U.S. International Trade Commission

Publication 4143 April 2010

Washington, DC 20436

In the Matter of

Investigation Nos. 337-TA-608, -612 

Certain Nitrile Gloves 

and 

Certain Nitrile Rubber Gloves
U.S. International Trade Commission

COMMISSIONERS 

Shara L. Aranoff, Chairman 

Daniel R. Pearson, Vice Chairman 

Deanna Tanner Okun 

Charlotte R. Lane 

Irving A. Williamson 

Dean A. Pinkert 

Address all communications to 

Secretary to the Commission 

United States International Trade Commission 

Washington, DC 20436
U.S. International Trade Commission

Washington, DC 20436 

www.usitc.gov

Publication 4143 April 2010

In the Matter of

Investigation Nos. 337-TA-608, -612 

Certain Nitrile Gloves 

and 

Certain Nitrile Rubber Gloves

UNITED ST ATJ:S INTERNA TIOSAL TRADE CO~M SS ON 

W .... '.I ..... D.C. ZOOi 

CERTAIN NITRitE GI,o",J:S 

1., ... d • • UOll No. 1J7·TA-61l 

CUITAIN NITRILE RUBBERGLO"'ES 

NOTICE OF COMMISSION DETERMINATION O F NO VIOLATION OF 

SECT10S 337; TERMINATIOll' OFT" E INVl"STIGATION 

AGENCY; U.S.lotomllional TndoConuni .. ion. 

ACTION: NOIice. 

SU~MAll.Y: Notice iI bc<d>y &i .... !hal ,be U.S. Lntem.Uional Trade Conunilok>n .... _" ~ 

deIennined lha! then i • ..., YioI2tion of 19 U.S.C. § In7 by respondeou in !be abo ... "'r", .. .....J 

;'w.ltiption. The ;n .... ;gabon ;, <=nina'ed. 

!'OR FURTIIER INFORMATION COSTACT, Michelle Wal, ..... 0010< oflbe Gcnmol 

Counoe~ U.S. Ln<enWk>nal Tndo Conuni~ SOO E Street. S. W. Woshiogton. D.C. 20436. 

«\ephono (202) 708·S468. Cop;es ofllOn-conJidential do<:lIDI<Jl!s filed in <OMe<:Ii"" .... i1/llbi. 

investipian .... or ""ill be .>1Iilabk fOr insp«tion durina; ollkial bu,iDeO' hours (S:4S •. m. 10 

S:]S p.m.) in tile Office of tile Scoretar)'. U.s. International Tndo COmmillion, SOO E S~ 

S.W .• W~ D.C. 204:;6. tel,,:,..o.,. (202) 20S-2000. Gencn.] infornutioo concerni~ the 

Commisoion may WeI be oblained by fICC"" "lI iullltcmet...-vcr II h'''';I'''.,. .... wile VOl'. Tho 

public """"" for Ibi. in.estiptian may be viewed 0f1!be Commission', elocbtlnk dod .. 

(EDlS) 1I1'/Ir-(!111i!; lui'" WI'. Hcaring-impairtd]lCflOOS ..... ,l\iOOll !hal infurmotion on thia 

matter cal) be obtained by con1a<Ii"ll tIIc Conuni .. k>n·. TOO t«nIinaI "" (202) 2O'i·18]O. 

SUPPLEMENTARY INFORMATION: The Conunillion natitoted Inv. No. )37·TA-608 on 

luly 6. 2001. baoed "" • oomploint filed by TiUotOOll COI,.,.'ti"" d.b.L Bell Mmufacnrrin, 

CornpMy (""TilloUonj. The """",tain' .Uelled viol.!i"", of S«1ion 3J7 oflb< Tori/f Ac, of 

1930 ( 19 U.S.C. f \JJ7) in 1be ill1]><>lU!iotl into ,be United S1a1eO. tile sale roo- importation ...... 
the sale within the United States after importation of certain nitrile gloves by reason of 

inhngement of various claims of United States Patent No. Re. 35,616 (“the ‘616 patent”). The 

complaint named over thirty respondents. The Commission instituted a second investigation, 

Inv. No. 337-TA-612, on August 22,2007, based on a complaint filed by Tillotson. That 

complaint also alleged violations of section 337 in the importation into the United States, the sale 

for importation, and the sale within the United States after importation of certain nitrile gloves by 

reason of infringement of various claims of the ‘616 patent and named seven respondents. On 

September 19,2007, the ALJ consolidated Inv. No. 337-TA-608 with Inv. No. 337-TA-612. 

On August 25,2008, the ALJ issued a final ID and recommended determination on 

remedy and bonding in the above-referenced consolidated investigation, finding that the active 

respondents did not violate section 337. Specifically, he found that while the majority of accused 

gloves infringe claims 17, 18, and 19 of the ‘616 patent, the asserted claims are invalid. He 

concluded that when the patentees amended the claims through a reissue application filed more 

than two years after the grant of the original patent, they improperly enlarged the scope of the 

claims, rendering them invalid. The ALJ further concluded that the claims are invalid because 

the patentees filed a defective reissue declaration when applying for the reissue patent. He 

rejected other arguments of invalidity and unenforceability. Accordingly, the ALJ concluded that 

respondents had not violated section 337. 

On September 8,2008, complainant Tillotson filed a petition for review, as did several 

respondents. On September 16,2008, respondents filed a response to complainant’s petition and 

complainant filed a response to respondents’ petition. 

On October 24,2008, the Commission determined to review a portion of the ALJ’s ID 

and requested briefing from the parties on the issues under review and on remedy, the public 

interest, and bonding. On November 10,2008, complainant Tillotson, certain respondents, and 

the Commission investigative attorney (724“) each filed responses to the Commission’s request 

for written submissions. On November 17,2008, complainant, certain respondents, and the IA 

filed reply submissions. 

Having examined the record of this investigation, including the ALJ’s ID and the 

submissions of the parties, the Commission has determined to affirm the ALJ’s determination 

that the respondents did not violate section 337 because the asserted claims are invalid under 35 

U.S.C. tj 251 and 37 C.F.R. tj 1.175(a) (1996), but will clarify a portion of his claim construction 

in a separate opinion. 

2 
The authority for the Commission’s determination is contained in section 337 of the 

Tariff Act of 1930, as amended (19 U.S.C. 8 1337)’ and in section 210.45 of the Commission’s 

Rules of Practice and Procedure (1 9 C.F.R. 9 2 10.45). 

By order of the Commission. 

Marilyn K* R. Abbott 

Secretary to the Commission 

Issued: December 22,2008 

3 
CERTAIN NITRILE GLOVES AND 

CERTAIN NITRILE RUBBER GLOVES 

337-TA-608 and 612 

(Consolidated) 

PUBLIC CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached NOTICE OF COMMISSION 

DETERMINATION OF NO VIOLATION OF SECTION 337; TERMINATION 

OF THE INVESTIGATION has been served by hand upon the Commission 

Investigative Attorney Vu Q. Bui, Esq., and the following parties as indicated, on 

December 23, 2008. 

/Mrilyn R. gott, Secretary JdiG 

U.S. Int ernafonal Trade Commission 

500 E Street, SW 

Washington, DC 20436 

ON BEHALF OF COMPLAINANT TILLOTSON 

CORPORATION: 

Gilbert B. Kaplan, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, NW 

Suite 200 

Washington, DC 20006-4706 

P-202-737-0500 

F-202-626-3 73 7 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

WVia First Class Mail 

( )Other: 
Page 2 - Certificate of Service 

ON BEHALF OF RESPONDENTS TOP GLOVE 

CORPORATION Bhd, LAGLOVE 0 Sdn. 

Bhd.,HARTALEGA HOLDINGS Bhd., KOSSAN 

RUBBER INDUSTRIES Bhd., Ltd., RIVERSTONE 

RESOURCES Sdn. Bhd., YTY HOLDINGS Sdn. Bhd. 

PT MEDISAFE TECHNOLOGIES, JL, PT 

SHAMROCK, LATEXX PARTNERS BERHAD and 

JDA (Tianiin) PLASTIC RUBBER COMPANY, 

LIMITED: 

Perry R. Clark, Esq. 

KIRKLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

P-415-439- 1400 

F-415-439-1500 

ON BEHALF OF RESPONDENTS ANSELL 

HEALTHCARE PRODUCTS LLC, ANSELL 

PROTECTIVE PRODUCTS, INC., AND ANSELL 

{THAILAND) LIMITED: 

Thomas B. Kenworthy, Esq. 

MORGAN LEWIS & BOCKIUS LLP 

1701 Market Street 

Philadelphia, PA 19 103-292 1 

P-2 15-963-5000 

F-215-963-5001 

ON BEHALF OF RESPONDENT QFW 

INCORPORATED: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL, PLC 

2730 E. Broadway Boulevard, Suite 160 

Tucson, AZ 85716-5384 

P-520-326-4600 

F-520-203 -0202 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

#Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

QVia First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail KV;r Class Mail 
Page 3 - Certificate of Service 

ON BEHALF OF RESPONDENT PROTECTIVE 

INDUSTRIAL PRODUCTS, INCORPORATED: 

Elizabeth G. Borland, Esq. 

SMITH GAMBRELL & RUSSELL, LLP 

Promenade 11, Suite 3 100 

+1230 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-815-3500 

F-404-815-3509 

ON BEHALF OF RESPONDENT ADENNA, 

INCORPORATED: 

Douglas A. Frymer, Esq. 

498 1 Irwindale Avenue 

Suite 100 

Irwindale, CA 91 706 

P-626-8 13-7076 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

g0 Via First Class Mail 

( )Other: 

ON BEHALF OF RESPONDENT LIBERTY GLOVE: 

Rosa S. Jeong, Esq. 

GREENBERG TRAURIG LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-33 1-3 100 

F-202-331-3101 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

&Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

aVia First Class Mail 

( )Other: 
Page 4 - Certificate of Service 

ON BEHALF OF RESPONDENT TRONEX 

INTERNATIONAL, INCORPORATED: 

Maureen F. Browne, Esq. 

COVINGTON & BURLING LLP 

120 1 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

P-202-662-6000 

F-202-662-629 1 

ON BEHALF OF RESPONDENTS CARDINAL 

HEALTH, INC., CARDINAL HEALTH 200, INC., 

AND CARDINAL HEALTH MALAYSIA 211 SDN 

BHD: 

Paul F. Brinkman, Esq. 

ALSTON & BIRD LLP 

950 F Street, NW 

Washington, DC 20004 

P-202-756-3 3 00 

F-202-756-3333 

ON BEHALF OF RESPONDENTS HENRY SCHEIN, 

INC., HSi GLOVES, INC. AND SMART GLOVE 

HOLDINGS Sdn.Bhd.,:: 

Scott M. Daniels, Esq. 

WESTERMAN, HATTORI, DANIELS 

& ADRIAN, LLP 

1250 Connecticut Avenue, NW - Suite 700 

Washington, DC 20036 

P-202-822-1100 

F-202-822-1111 

RESPONDENTS: 

DentexxRirst Medica Infection Control 

Association 

3704C Boren Dr. 

Greensboro, NC 27407 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

()u Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

@ Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(%Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Via First Class Mail 

( )Other: 
Page 5 - Certificate of Service 

Medtexx Partners, Inc. 

102 Engle St. FL2 

Englewood, NJ 0763 1 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(*Via First Class Mail 

( )Other: 
PUBLIC VERSION 

L1'oTfED SfATES IlO'EItXAllOl';AL lllADE COMMISSlOl'; 

W"'br.O.c. 

I. Ike M. "te of 

Cf.RT AIN NITRILE GWVES 

c f.ln AIN NtTIlU.E IW BBt:.It GWVr,5 

ro.\!..\1 ISSlOl'; OPINION 

joodac·.("AUJ_n .... ;... .......... ;, no) ,",'"ix of .. ' 001 JJ7 of .... T.-ilf ..... of 1930(19 

U.s.c., U)1) in .... obo_fmnoed in,...u,.oioa.. The: C""",,;.w. odop ..... ALJ't r",", 

initial del""";"",,,,,, ("ID 1 issued "" A"i"" lj. 2001. and hi< onIet """"",I .. tho diJpUtcd daim 

1mnJ 1_"" MardlI 4.2OOI. III lh4o,i"",,, .... Commissimd .. maj .... AlJ·.diOCUHion 

C<>mntiJoion', o~_ ....... "+ .. ... ,,....., lliao .... ,( ...... 0IId do .... _1lis 

, 
PUBLIC VERSION 

I. BACKGROUND 

A. Procedural History 

The Commission instituted Investigation No. 337-TA-608 on July 6,2007, based on a 

complaint filed by Tillotson Corporation d.b.a. Best Manufacturing Company (“Tillotson”). 72 

Fed. Reg. 37052 (July 6,2007). The complaint alleged violations of section 337 in the importation 

into the United States, the sale for importation, and the sale within the United States after 

importation of certain nitrile gloves by reason of infringement of claims 1, 17,18, and 19 of United 

States Reissue Patent No. Re. 35,616 (“the ‘616 patent”). The complaint named thirty-one 

respondents. The Commission instituted a second investigation, Investigation No. 3 37-TA-6 12, 

on August 22,2007, based on another complaint filed by Tillotson. 72 Fed. Reg. 47072 (Aug. 22, 

2007). The complaint similarly alleged violations of section 337 in the importation into the United 

States, the sale for importation, and the sale within the United States after importation of certain 

nitrile rubber gloves by reason of infringement of the same four claims. The complaint named 

seven additional respondents. On September 19,2007, the ALJ consolidated the two 

investigations and allowed Tillotson to name fifteen additional respondents. 

On December 13,2007, Judge Essex held a Murkman hearing to consider the meaning of 

several claim terms. On March 14,2008, he issued an order construing the terms. See Order No. 

63 : Order Construing the Terms of the Asserted Claims of the Patents at Issue (“Murkman Order”). 

The ALJ held an evidentiary hearing on May 19-27,2008, and thereafter received post-hearing 

briefing from the parties. 

On August 25,2008, the ALJ issued his final ID, finding that the respondents did not 

2 
PUBLIC WRSION 

violate section 337 and also including his recommended determination on remedy and bonding. 

He found that while the vast majority of accused gloves infringe claims 1, 17, 18, and 19 of the 

‘616 patent and that the domestic industry requirement was met, the asserted claims are invalid. ID 

at 48-49 & 11 1-17. Specifically, he found that when the patentees amended the claims through a 

reissue application filed more than two years after the grant of the original patent, they improperly 

enlarged the scope of the claims, rendering them invalid. ID at 54-66. The ALJ also found the 

claims invalid because the patentee filed a defective reissue declaration when applying for the 

reissue patent. ID at 66-74. He rejected respondents’ arguments, however, that the claims are 

invalid as anticipated and obvious and that they are invalid for failing to disclose the best mode, for 

lack of enablement, and for being indefinite. ID at 75- 10 1. He also rejected respondents’ 

arguments that the patent is unenforceable for inequitable conduct. ID at 10 1 - 10. Accordingly, the 

ALJ concluded that respondents did not violate section 337. 

On September 8, 2008, Tillotson filed a petition for review, challenging the ALJ’s 

interpretation of the original claim phrase “predetermined pressure” and his conclusion that the 

asserted claims are invalid. On the same day, certain respondents filed a contingent petition for 

review, challenging another claim construction and the ALJ’s infringement determinations. In 

addition, they challenged the ALJ’s conclusions that the claims are not invalid for failing to 

disclose the best mode and for lack of enablement, but did not challenge his conclusions with 

regard to anticipation or obviousness. Finally, they challenged the ALJ’s conclusion that the patent 

Under the Commission’s rules, contingent petitions for review are treated as petitions for review. 

19 C.F.R. (j 210.42(b)(3). 

3 
PUBLIC WRSION 

is not unenforceable for inequitable conduct. 

On October 24,2008, the Commission determined to review a portion of the ALJ’s final ID. 

Specifically, the Commission determined to review (1) the ALJ’s claim construction of the term 

“predetermined pressure;” (2) his determination that the claims are invalid under 35 U.S.C. 6 251 

because of a broadening reissue; (3) his determination that the claims are invalid because of a 

deficient reissue declaration filed under 37 C.F.R. 5 1*175(a) (1 996); (4) his determination that the 

claims are not invalid for failing to disclose the best mode; and (5) his determination that the 

claims are not invalid for lack of enablement. The Commission determined not to review the 

remaining issues. Finally, the Commission requested briefing on the issues on review, remedy, the 

public interest, and bonding. 

On November 10,2008, Tillotson, certain respondents, and the Commission investigative 

attorney (“IA”) each filed responses to the Commission’s request for written submissions. See 

Complainant’s Memorandum in Response to the Commission’s Determination to Review-in-Part 

the Administrative Law Judge’s Final Initial Determination (“Comp. Submission”); Respondents’ 

Written Submission on the Issues Under Review by the Commission; Office of Unfair Import 

Investigations’ Response to Questions Posed in the Commission Notice of October 24,2008 and 

Briefing on the Issue of Remedy, Public Interest, and Bonding. On November 17,2008, Tillotson, 

the respondents, and the IA each filed reply submissions. 

B. Patent at Issue 

The ‘616 patent is entitled “Elastomeric Covering Material and Hand Glove Made 

Therewith.” It is a reissue of United States Patent No. 5,014,362 (“the ‘362 patent”), which issued 

4 
PUBLIC VERSION 

on May 14, 199 1 , based on an application filed on May 1 1, 1990. The reissue application that 

resulted in the ‘616 patent was filed on November 13, 1995, and issued on September 30, 1997. 

The ‘6 16 patent has twenty-four claims, three of which have been cancelled, but only claims 1, 17, 

18, and 19 are asserted in this investigation. The claims are generally directed to gloves that are 

designed to conform to the shape of the hand when stretched and then to relax so the pressure on 

the hand is substantially reduced. 

11. ANALYSIS 

The claim term “predetermined pressure” does not appear in the reissued claims, but 

appeared in original claim 1 of the ‘362 patent and is relevant to the broadening reissue question 

raised by the parties. Claim 1 of the ‘61 6 patent, with its additions shown in italics, its deletions in 

brackets, and the disputed claim tern in bold, recites: 

1. A closelyjitting glove comprising a layer of elastomeric material (a) comprising nitrile 

butadiene rubber, (6) having an initial configuration adapted to receive andfit 

closely about a hand, and (c) characterized by (i) being substantially impermeable 

to water vapor and liquid water, (ii) having a tensile strength of at least about 1500 

psi as measured according to ASTM D-4 12 on a sample of the elastomeric material 

having a thickness from about 4.0 to about 4.5 mils, and (iii) having a thickness and 

elastic properties such that the glove is capable of being stretched tojit closely 

about the hand and when stretched from the initial configuration to fit closely about 

the hand, the elastomeric material conforms to the configuration of the hand, 

initially exerting [a predetermined] an initial pressure on the hand and 

thereafter stillfitting closely about the hand, but relaxing, within about 6 minutes 

after the glove is stretched tofit about said hand, to exert on the hand a reduced 

pressure which is [substantially] less than about [SO%] 50% of the [predetermined] 

initial pressure. 

JX-3 (‘616 patent), col. 6,ll. 33-50. 

The ALJ construed the claim term “predetermined pressure” to mean “the amount of 

5 
PUBLIC VERSION 

pressure decided in advance that will be exerted on the hand by the glove after the glove is 

donned.” Markman Order at 14. In reaching this interpretation, he disposed of Complainant’s 

assertion that the terms “predetermined” and “initial” have the same meaning by relying on the 

inventor’s explanation in the reissue prosecution history that the “term ‘predetermined’ has been 

replaced with the term ‘initial’ in amended claim 1 to more clearly define the glove in claim 1 in 

accordance with p. 1 1 line 22 of the applicant’s description.” Id. at 14 (citing JX-4 at TLC000035); 

see also JX-4 at TLC000178. The ALJ’s conclusion is further supported by the fact that the 

inventor distinguished the two terms when he stated during prosecution that claim 1 recites a glove 

that “when stretched from an initial configuration to fit closely about the hand, exerts an initial, 

rather thanpredetermined, pressure on the hand . . .” JX-4 at TLCOOOOl 1 & TLCOOOl78 

(emphasis added); see also ID at 59-60. The ALJ also relied on the ‘61 6 patent specification to 

support his conclusion, finding that the specification only uses the term “initially” to describe when 

the predetermined pressure is exerted on the hand, i. e., “initially exerting a predetermined pressure 

on the hand,” an$ does not use the term interchangeably with the term “predetermined.” Markman 

Order at 15. He concluded therefore that giving them the same meaning would render the term 

“predetermined” superfluous. Id. 

The ALJ also found that the intrinsic evidence did not suggest that the patentees were their 

own lexicographers. Marbzan Order at 14. As such, the ALJ gave the term “predetermined 

pressure” what he regarded as its ordinary and customary meaning to a person of ordinary skill in 

the art, namely, “the amount of pressure decided in advance that will be exerted on the hand by the 

glove after the glove is donned.” Id. at 15. It is our understanding that by citing Phillips v. A WH 

6 
PUBLIC VERSION 

Corp., 415 F.3d 1303, 1322 (Fed. Cir. 2005) (en bane), he was indicating that he based his claim 

construction on dictionary definitions, and that, although he did not cite specific dictionaries, the 

dictionaries that he relied upon were those identified by respondents: MERRIAM-WEBSTER’S 

COLLEGIATE DICTIONARY 9 15 (1 0th ed. 2002); THE RANDOM HOUSE COLLEGE DICTIONARY 

REVISED EDITION 1044 (Revised ed. 1988); THE AMERICAN HERITAGE DICTIONARY OF THE 

ENGLISH LANGUAGE 1382 (4th ed. 2000). 

In discussing whether the inventors improperly enlarged the scope of the claims through a 

reissue application filed more than two years after the grant of the original patent under 35 U.S.C. 

0 25 1, the ALJ further discussed his interpretation of the term “predetermined pressure.” He stated 

that the “initial pressure” can be “any pressure that is first exerted, while the amount of pressure for 

‘predetermined pressure’ requires that the amount be ‘decided in advance.”’ ID at 61. He labeled 

the requirement that the pressure be decided or determined in advance as a “cognitive function.” 

ID at 61. Complainant Tillotson seizes on the phrase “cognitive function” to argue that the ALJ 

required a mental step, which according to Tillotson is not appropriate in a product claim. Comp. 

Submission at 15-1 6. Tillotson improperly attributes meaning to the phrase “cognitive function” 

that was not intended by the ALJ. Claim 1 does not require a mental step insomuch as no one needs 

to select a specific pressure in designing a glove. Indeed, the ALJ said so in his opinion. He stated 

in footnote 12 of his ID that his “claim construction does not require a specific selection or 

determination of a speczjk pressure in advance, rather the [ALJ’s] claim construction requires a 

determination in advance of what amount of pressure will be exerted on the hand by the glove after 

the glove is domed.” ID at 61 n. 12 (emphasis added). Thus, a glove maker need not design a 

7 
PUBLIC VERSION 

glove to achieve a particular pressure; it is sufficient that the amount of the pressure for a particular 

glove is known in advance of putting the glove on. ID at 65-66. One way this is done, according 

the specification and to the ALJ, is by simulating the predetermined pressure with the 100% 

Modulus Test. JX-3 (‘616 patent), col. 6’11. 11-26 & Figures 1 & 2; ID at 64. 

Tillotson further attempts to read ambiguity into the ALJ’s opinion where none is 

warranted by arguing that his statement in footnote 12 quoted above is inconsistent and unclear. 

However, the ALJ simply said that the claim term “predetermined pressure” requires that the 

amount of the pressure that will be exerted on the hand be determined before it is exerted. ID at 6 1 

n. 12; see also ID at 62 (“What this demonstrates is not a specific amount of pressure or that the 

patentees had any ‘foreknowledge’ of what the actual amount of pressure would be, rather it 

evidences that the amount of pressure on the hand when the glove is donned was decided in 

advance.” (emphasis in original)). He went on to explicitly reject respondents’ argument that 

claim 1 requires selection of a specific pressure in advance. He explained that “[tlhere is no 

requirement that [the] ‘predetermined pressure’ be a specific starting pressure or that the designer 

of the glove ‘knowingly select a specific pressure.”’ ID at 63. His opinion is consistent throughout: 

the specific pressure exerted by the glove need not be selected when designing the glove. ID at 62 

& 64. Nor is it enough for the predetermined pressure to be fixed by basic physics, he found. We 

agree with his reasoning for this conclusion and note that Tillotson’s argument essentially boils 

down to an assertion that the pressure is determinable, when the claims clearly require that the 

pressure be determined in advance. ID at 64-66. Thus, in our view, there is no confusion as to the 

meaning of the ALJ’s claim construction. 

8 
PUBLIC VERSION 

Because we agree with the ALJ that the claim term ‘‘predetermined pressure” means “the 

amount of pressure decided in advance that will be exerted on the hand by the glove after the glove 

is donned,” we agree with him regarding the invalidity of the asserted claims. Accordingly, the 

Commission affirms the ALJ’s determination that there is no violation of section 337. Further, the 

Commission adopts the ALJ’s ID and Markman Order in their entirety with the clarifications 

provided above. 

By order of the Commission. 

MarilwAbbott 

Secretary to the Commission 

Issued: January 15,2009 

9 
CERTAIN NITRILE GLOVES AND 

CERTAIN NITRILE RUBBER GLOVES 

337-TA-608 and 612 

(Consolidated) 

PUBLIC CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached COMMISSION OPINION 

(PUBLIC VERSION) has been served by hand upon the Commission Investigative 

Attorney Vu Q. hi, Esq., and the following parties as indicated, on 

January 15, 2009. 

U.S. Lternational Trade Commission 

500 E Street, SW 

Washington, DC 20436 

ON BEHALF OF COMPLAINANT TILLOTSON 

CORPORATION: 

Gilbert B. Kaplan, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, NW 

Suite 200 

Washington, DC 20006-4706 

P-202-737-0500 

F-202-626-3737 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

( ) Other: 
Page 2 - Certificate of Service 

ON BEHALF OF RESPONDENTS TOP GLOVE 

CORPORATION Bhd, LAGLOVE (M) Sdn. 

Bhd.,HARTALEGA HOLDINGS Bhd., KOSSAN 

RUBBER INDUSTRIES Bhd., Ltd., RIVERSTONE 

RESOURCES Sdn. Bhd., YTY HOLDINGS Sdn. Bhd. 

PT MEDISAFE TECHNOLOGIES, JL, PT 

SHAMROCK, LATEXX PARTNERS BERJ3AD and 

JDA (Tianiin) PLASTIC RUBBER COMPANY, 

LIMITED: 

Perry R. Clark, Esq. 

KIRISLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

P-415-439-1400 

F-415-439-1500 

ON BEHALF OF RESPONDENTS ANSELL 

HEALTHCARE PRODUCTS LLC, ANSELL 

PROTECTIVE PRODUCTS, INC., AND ANSELL 

{THAILAND) LIMITED: 

Thomas B. Kenworthy, Esq. 

MORGAN LEWIS & BOCKIUS LLP 

1701 Market Street 

Philadelphia, PA 191 03-292 1 

P-215-963-5000 

F-215-963-5001 

ON BEHALF OF RESPONDENT ORP 

I NCOKPO KATE D: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL, PLC 

2730 E. Broadway Boulevard, Suite 160 

Tucson, AZ 85716-5384 

P-520-326-4600 

F-520-203-0202 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Via First Class Mail 

Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

ther: 
Page 3 - Certificate of Service 

ON BEHALF OF RESPONDENT PROTECTIVE 

INDUSTRIAL PRODUCTS, INCORPORATED: 

Elizabeth G. Borland, Esq. 

SMITH GAMBRELL & RUSSELL, LLP 

Promenade 11, Suite 3 100 

+1230 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-815-3500 

F-404-815-3509 

ON BEHALF OF RESPONDENT ADENNA, 

INCORPORATED: 

Douglas A. Frymer, Esq. 

498 1 Irwindale Avenue 

Suite 100 

Irwindale, CA 9 1706 

P-626-8 13-7076 

ON BEHALF OF RESPONDENT LIBERTY GLOVE: 

Rosa S. Jeong, Esq. 

GREENBERG TRAURIG LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-33 1-3 100 

F-202-331-3101 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Via First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

( )Other: 
Page 4 - Certificate of Service 

ON BEHALF OF RESPONDENT TRONEX 

INTERNATIONAL, INCORPORATED: 

Maureen F. Browne, Esq. 

COVINGTON & BURLING LLP 

120 1 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

P-202-662-6000 

F-202-662-629 1 

ON BEHALF OF RESPONDENTS CARDINAL 

HEALTH, INC., CARDINAL HEALTH 200, INC., 

AND CARDINAL HEALTH MALAYSIA 211 SDN 

BHD: 

Paul F. Brinkman, Esq. 

ALSTON & BIRD LLP 

950 F Street, NW 

Washington, DC 20004 

P-202-756-3300 

F-202-756-3333 

ON BEHALF OF RESPONDENTS HENRY SCHEIN, 

INC., HSi GLOVES, INC. AND SMART GLOVE 

HOLDINGS Sdn.Bhd.,:: 

Scott M. Daniels, Esq. 

WESTERMAN, HATTORI, DANIELS 

& ADRIAN, LLP 

1250 Connecticut Avenue, NW - Suite 700 

Washington, DC 20036 

P-202-822-1100 

F-202-822- 1 1 1 1 

RESPONDENTS: 

DentexxEirst Medica Infection Control 

Association 

37046 Boren Dr. 

Greensboro, NC 27407 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

ther: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

ia First Class Mail 

( )Other: 
Page 5 - Certificate of Service 

Medtexx Partners, Inc. 

102 Engle St. FL2 

Englewood, NJ 0763 I 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Via First Class Mail 

PUBLIC VERSION 

Pass, Ph.D, Esq. of King & Spalding LLP of Atlanta, Georgia. 

For the Respondents Cardinal Health Inc., Cardinal Health 200, Inc. and Cardinal Health 

Malaysia 21 I Sdn. Bhd. : 

Paul F. Brinkman, Esq. and Bryan Blades, Esq. of Alston & Bird LLP of Washington, D.C. 

Michael S. Connor, Esq.; Don W. Anthony, Esq.; Brian F. McMahon, Esq.; and Jessica J. Sibley, 

Esq. of Alston & Bird LLP of Charlotte, North Carolina. 

For the Respondents Ansell Ltd.. Ansell Healthcare Products LLC, Ansell Protective Products, 

Inc. and Ansell (Thailand) Ltd. : 

Thomas B. Kenworthy, Esq.; David W. Marston, Jr., Esq.; Kenneth J. Davis, Esq.; and Rebecca J. 

Hillyer, Esq. of Morgan, Lewis & Bockius LLP of Philadelphia, Pennsylvania. 

For the Respondent Libery Glove, Inc. : 

Luisa Jaffe, Esq. of Claremont Law Group, Inc. of Claremont, California. 

Rosa S. Jeong, Esq. of Greenburg Traurig LLP of Washington, D.C. 

For the Respondents Henry Schein, INc., HSI Gloves, Inc., Smart Glove Corporation Sdn. Bhd. 

and Smart Glove Holdings, Sdn. Bhd. : 

Scott M. Daniels, Esq. of Westerman, Hattori, Daniels and Adrian LLP of Washington, D.C. 

For the Respondents Top Glove, Corp Bhd., Riverstone Resources Sdn. Bhd., Smart Glove 

Holdings Sdn. Bhd., Laglove (M) Sdn. Bhd., Latexx Partners Berhad, YTY Holdings, Sdn. Bhd. 

Kossan Rubber Industries Bhd Ltd. ; PT Mediasafe Technologies, JL & Hartalega Hodlings Bhd., 

JDA (Tianiin) Plastic Rubber Co. Ltd., PT Shamrock Manufacturinn Corporation and PT 

Medisa fe Technologies: 

Perry R. Clark, Esq.; Jenny N. Lee, Esq.; and Michael T. Pieja, Esq. of Kirkland & Ellis LLP of 

San Francisco, California. 

For the Respondent ORO, Inc., db/a GRP Gloves: 

Daniel J. Quigley, Esq. of Quigley & Whitehill PC of Tucson, Arizona. 

For the Respondent Protective Industrial Products: 

Elizabeth Borland, Esq. of Smith, Gambrell, and Russell LLP of Atlanta, Georgia. 

For the Respondent Dynarex Corporation: 

J. Kevin Horgan, Esq. of DeKieffer and Horgan of Washington, D.C. 
PUBLIC VERSION 

For Respondent Adenna, Inc. : 

Douglas A. Fryrner, Esq. of Irwindale, California. 

For Respondent Dentexx/First Medica Infection Control Association: 

James Lester, Esq. of Maccord Mason PLLC of Greensboro, North Carolina 

For Respondent Tronex International , Inc. : 

Marueen F. Browne, Esq. of Heller Ehrman, LLP of Washington, D.C. 

For the Commission Investigative Staff 

Lynn I. Levine, Esq., Director; Thornas S. Fusco, Esq., Supervising Attorney; Erin D.E. Joffre, 

Esq., Investigative Attorney of the Office of Unfair Irnport Investigations, U.S. International 

Trade Commission, of Washington, D.C. 
PUBLIC VERSION 

TABLE OF CONTENTS 

I . 

I1 . 

I11 . 

Iv . 

V . 

VI . 

VI1 . 

VI11 . IX . 

BACKGROUND .............................................................................................................................. 1 

A . Institution and Procedural History of This Investigation ......................................................... 1 

B . The Parties ............................................................................................................................... 8 

C . Overview ofthe Technology ................................................................................................. 17 

D . The Patent At Issue ................................................................................................................ 18 

E . The Products At Issue ............................................................................................................ 19 

IMPORTATION OR SALE ........................................................................................................... 19 

CLAIM CONSTRUCTION ............................................................................................................ 20 

A . Applicable Law ...................................................................................................................... 20 

B . The Disputed Claim Terms and Their Proper Construction .................................................. 22 

1 . “Less than about 50%’’ ................................................................................................. 22 

INFRINGEMENT DETERMINATION ........................................................................................ 24 

A . Applicable Law ...................................................................................................................... 24 

1 . Claim 1 ......................................................................................................................... 26 

2 . Claims 17, 18 and 19 .................................................................................................... 49 

VALIDITY ..................................................................................................................................... 53 

A . Background ............................................................................................................................ 53 

B . 35 U.S.C. $251(Broadening Reissue) .................................................................................... 54 

C . Defective Reissue Certificate ................................................................................................ 66 

D . Anticipation ........................................................................................................................... 75 

E . Obviousness ........................................................................................................................... 79 

1 . Analysis ofthe Asserted Claims .................................................................................. 83 

2 . Secondary Considerations ............................................................................................ 88 

F . Best Mode .............................................................................................................................. 90 

G . Enablement ............................................................................................................................ 96 

H . Definiteness ......................................................................................................................... 100 

UNENFORCEABILITY .............................................................................................................. 101 

A . Applicable Law .................................................................................................................... 101 

B . Reissue Declaration ............................................................................................................. 103 

C . Scott Tester Data ................................................................................................................. 107 

D . Q-Test Machine ................................................................................................................... 110 

DOMESTIC INDUSTRY ............................................................................................................. 111 

A . Technical Analysis .............................................................................................................. 111 

1 . N-DEX Gloves ........................................................................................................... 113 

B . Economic Analysis .............................................................................................................. 115 

CONCLUSIONS OF LAW ................................................................................................. 118 

INITIAL DETERMINATION AND ORDER ............................................................................. 1 19 
PUBLIC VERSION 

Pursuant to the Notices of Investigation, 72 Fed. Reg. 37052 and 72 Fed. Reg. 47072 

(2007), this is the Initial Determination of the consolidated investigations in the matter of 

Certain Nitrile Gloves, United States International Trade Commission Investigation No. 3 3 7-TA608, and Certain Nitrile Rubber Gloves, United States International Trade Commission 

Investigation No. 337-TA-612. See 19 C.F.R. $ 210.42(a). 

It is held that no violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 

$ 1337, has occurred in the importation into the United States, the sale for importation, or the 

sale within the United States after importation of certain nitrile rubber gloves by reason of 

infringement of one or more of claims 1, 17 through 19 of United States Patent No. Re. 35,616. 
PUBLIC VERSION 

CFF 

CIB 

The following abbreviations may be used in this Initial Determination: 

Complainants’ proposed findings of fact 

Complainants’ initial post-hearing brief 

1 CDX 

COSFF 

CPX 

I Complainants’ demonstrative exhibit I 

Complainants’ objections to Staffs proposed findings of fact 

Complainants’ physical exhibit 

CRB 

cx 

Dep. 

I CORFF I Complainants’ objections to Respondents’ proposed findings of fact 

Complainants’ reply post-hearing brief 

Complainants’ exhibit 

Deposition 

JSUF 

Jx 

Joint Statement of Undisputed Facts 

Joint Exhibit 

ROCFF 

ROSFF 

I I I 

Respondents’ objections to Complainants’ proposed findings of fact 

Respondents’ objections to Staffs proposed findings of fact 

I Respondents’ demonstrative exhibit I 

RRB 

RRX 

I Respondents’ proposed findings of fact I 

Respondents’ reply post-hearing brief 

Respondents’ rebuttal exhibit 

1 Respondents’ initial post-hearing brief I 

SFF 

SIB 

Staffs proposed findings of fact 

Staffs initial post-hearing brief 

I Respondents’ physical exhibit I 

SOCFF 

SORFF 

SRB 

Staffs objections to Complainants’ proposed findings of fact 

Staffs objections to Respondents’ proposed findings of fact 

Staffs reply post-hearing brief 

1 Respondents’ exhibit I 
PUBLIC VERSION 

I. BACKGROUND 

A. Institution and Procedural History of This Investigation 

By publication of a notice in the Federal Register on July 6,2007, pursuant to subsection 

(b) of section 337 of the Tariff Act of 1930, as amended, the Commission instituted Investigation 

No. 337-TA-608 with respect to U.S. Patent No. Re. 35,616 (“the ‘616 Patent”) to determine: 

[whether there is a violation of subsection (a)(l)(B) of section 

337 in the importation into the United States, the sale for 

importation, or the sale within the United States after importation 

of certain nitrile gloves by reason of infringement of one or more 

of claims 1 and 17-19 of U.S. Patent No. Re. 35,616, and whether 

an industry in the United States exists as required by subsection 

(a)(2) of section 337. 

72 Fed. Reg. 37052 (2007). 

Tillotson Corporation d/b/a Best Manufacturing Company (“Tillotson”) of Menlo, 

Georgia, is the complainant. Id. The respondents named in the Notice of Investigation were: Top 

Glove Corporation Bhd. of Selangor. D.E., Malaysia; Ansell Ltd. of Victoria, Australia; Beijing 

Huateng Rubber Plastic of Beijing, China; Glovco(m) Sdn. Bhd. of Selangor D.E., Malaysia; 

Hartalega Holdings Bhd. of Kuala Lampur, Malaysia; Ideal Healthcare Group Co. Ltd. of 

Ningbo, China; JDA (Tianjin) Plastic Rubber Co. Ltd. of Tianjin, China; Kossan Rubber 

Industries Bhd. of Selangor D.E., Malaysia; Laglove (M) Sgn. Bhd. of Selangor, Malaysia; PT 

Medisafe Technologies of Utar, Indonesia; PT Shamrock Manufacturing Corporation of Sumatra, 

Indonesia; Riverstone Resources Sdn. Bhd. of Kuala Lumpur, Malaysia; Seal Polymer Industries 

Bhd. of Perak, Malaysia; Smart Glove Holdings Sdn. Bhd. of Selangor D.E., Malaysia; 

Supermax Corporation Bhd. of Selangor D.E., Malaysia; Yee Lee Corporation Bhd. of Perak 

Darul Ridzuan, Malaysia; YTY Holdings Sdn. Bhd. of Selangor D.E., Malaysia; Adenna, Inc. of 

Santa Fe Springs, California; Basic Medical Industries, Inc. of Chino, California; Cypress 

1 
PUBLIC VERSION 

Medical Products LLC of Chicago, Illinois; Darby Group Companies, Inc. of Jericho, New York; 

Dash Medical Gloves of Franklin, Wisconsin; Delta Medical Systems, Inc. d/b/a The Delta 

Group of Alpharetta, Georgia; Dentexflirst Medica Infection Control Assoc. of Greensboro 

North Carolina; Dynarex Corp. of Orangeburg, New York; Liberty Glove and Safety Co. of 

Walnut, California; Magla Products LLC of Albemarle, North Carolina; Protective Industrial 

Products, Inc. of Alpharetta, Georgia; QRP Inc. d/b/a QRP Gloves, Inc. of Tuscon, Arizona; 

Tronex International, Inc. of Denville, New Jersey and West Chester Holdings, Inc. of Monroe, 

Ohio. Id. The Commission Investigative Staff (“Staff’) of the Commission’s Office of Unfair 

Import Investigations is also a party in this investigation. Id. The investigation was originally 

assigned to Administrative Law Judge Bullock. Id. 

On August 2,2007, Judge Bullock issued an initial determination terminating respondent 

Cypress Medical Products, LLC from the investigation based on withdrawal of the Complaint. 

(See Order No. 7.) The Commission determined not to review the order. (See Notice of 

Commission Decision Not To Review an Initial Determination Terminating the Investigation as 

to Respondent Cypress Medical Products, LLC Based on Withdrawal of Complaint (August 22, 

2007).) 

On August 3,2007, Judge Bullock issued an initial determination terminating respondent 

Westchester Holdings, Inc. from the investigation based on settlement agreement. (See Order No. 

8.) The Commission determined not to review the order. (See Notice of Commission Decision 

Not To Review an Initial Determination Terminating the Investigation as to Respondent West 

Chester Holdings, Inc. On the Basis of a Settlement Agreement (August 29,2007).) 

2 
PUBLIC VERSION 

By publication of a notice in the Federal Register on August 22,2007, pursuant to 

subsection (b) of section 337 of the Tariff Act of 1930, as amended, the Commission instituted 

Investigation No. 337-TA-6 12 with respect to the ‘6 16 Patent to determine: 

[whether there is a violation of subsection (a)(l)(B) of section 

337 in the importation into the United States, the sale for 

importation, or the sale within the United States after importation 

of certain nitrile gloves by reason of infringement of one or more 

of claims 1 and 17-19 of U.S. Patent No. Re. 35,616, and whether 

an industry in the United States exists as required by subsection 

(a)(2) of section 337. 

72 Fed. Reg. 47072 (2007). 

Tillotson is the complainant. Id The respondents named in the Notice of Investigation 

are: Cardinal Health, Inc. of Dublin, Ohio; Cardinal Health 200, Inc. of McGaw Park, Illinois; 

Cardinal Health Malaysia 2 1 1 Sdn. Bhd. of Bayan Lepas, Malaysia; Henry Schein, Inc. of 

Melville, New York; HSI Gloves Inc. of Melville, New York; Latexx Partners Berhad of Dam1 

Ridzuan, Malaysia; and Medtexx Partners Inc. of Englewood, New Jersey. Id Staff was also 

named a party to the investigation. Id. The investigation was originally assigned to 

Administrative Law Judge Bullock. Id. 

On August 30,2007, Judge Bullock issued an initial determination terminating 

respondent Beijing Huateng Rubber Plastic & Latex Products Co., Ltd. fiom the investigation 

based on consent order. (See Order No. 13.) The Commission determined not to review the 

order. (See Notice of Commission Decision Not To Review an Initial Determination 

Terminating the Investigation With Respect to Respondent Beij ing Huateng Rubber Plastic & 

Latex Products Co., Ltd. Based On Consent Order (September 26,2007).) 

On September 4,2007, Judge Bullock issued an initial determination terminating 

respondent Delta Medical Systems, Inc. from the investigation based on settlement agreement. 

3 
PUBLIC VERSION 

(See Order No. 15.) The Commission determined not to review the order. (See Notice of 

Commission Decision Not To Review an Initial Determination Terminating the Investigation 

With Respect to Respondent Delta Medical Systems, Inc. On the Basis of a Settlement 

Agreement (September 26,2007).) 

On September 19,2007, the Complaint and Notice of Investigation were amended to add 

fourteen additional respondents. (See Order No. 2 1 .) The respondents named are subsidiaries of 

already named respondents, namely: Ansell (Thailand) Ltd.; Ansell Healthcare Products LLC; 

Ansell Protective Products Inc.; Top Glove Sdn. Bhd.; TG Medical (USA) Inc.; Hartalega Sdn. 

Bhd.; Phannatex USA Inc.; Perusahaan Getah Asas Sdn. Bhd.; Kossan Gloves Inc. d/b/a Sintex; 

PT Haloni Jane; Shamrock Manufacturing Company Inc.; Smart Glove Corporation Sdn. Bhd.; 

YTY Industry (Manjung) Sdn. Bhd.. Respondent Delta Medical Supply Group, Inc. d/b/a The 

Delta Group was also added as a respondent. The Commission determined not to review the 

order amending the Complaint and Notice of Investigation. (See Notice of Commission Decision 

Not to Review Initial Determination Granting Complainant’s Motion to Amend the Complaint 

and Notice of Investigation (October 17,2008).) 

On September 19,2007, Judge Bullock consolidated Investigation Nos. 337-TA-608 and 

337-TA-612. (See Order No. 19.) The Commission determined not to review the order 

consolidating the investigation. (See Notice of Commission Decision Not to Review Order No. 

19 (October 1 1,2007).) 

On the same day, Judge Bullock also issued an initial determination terminating 

respondent Magla Products LLC from the investigation based on settlement agreement. (See 

Order No. 20.) The Commission determined not to review the order. (See Notice of 

Commission Decision Not To Review an Initial Determination Terminating the Investigation 

4 
PUBLIC VERSION 

With Respect to Respondent Magla Products LLC On the Basis of a Settlement Agreement 

(October 1 1,2007).) 

On September 25,2007, Judge Bullock found respondents Basic Medical Industries, Inc.; 

Glovco (M) Bhd.; and Ideal Healthcare Group Co. Ltd. in default. (See Order No. 22.) The 

Commission determined not to review the order. (See Notice of Commission Decision Not To 

Review an Initial Determination Finding Three Respondents in Default (October 15,2007)) 

On October 16,2007, the Commission reassigned the consolidated investigations to this 

Court. (See Notice of a Commission Decision to Reassign Certain Section 337 Investigations.) 

On November 27,2008, the Court issued an initial determination terminating respondent 

Delta Medical Supply Group, Inc. d/b/a The Delta Group from the investigation based on 

settlement agreement. (See Order No. 41 .) The Commission determined not to review the order. 

(See Notice of Commission Decision Not To Review an Initial Determination Terminating the 

Investigation With Respect to Respondent Delta Medical Supply Group, Inc. On the Basis of a 

Settlement Agreement (December 21,2007)) 

On December 13,2007, the Court held a Markman hearing in the consolidated 

investigations. On March 14,2008, the Court issued its Order Construing the Terms of the 

Asserted Claims of the Patent at Issue. (See Order No. 63.) 

On January 8,2008, the Complaint was amended to reflect changes in Tillotson’s 

domestic industry, namely to reflect the recent sale of its manufacturing operations and 

subsidiaries and to include recently concluded license agreements. (See Order No. 47.) The 

Commission determined not to review the order. (See Notice of Commission Decision Not To 

Review Initial Determination Granting Complainant’s Motion to Amend the Complaint (January 

22,2008).) 

5 
PUBLIC VERSION 

On February 8,2008, the Court issued an initial determination terminating respondents 

Supermax Corporation Bhd. and Seal Polymer Industries Bhd. fiom the investigation based on 

settlement agreement. (See Order No. 55.) The Commission determined not to review the order. 

(See Notice of Commission Decision Not To Review an Initial Determination Terminating the 

Investigation With Respect to Respondents Supermax Corporation Bhd. and Seal Polymer 

Industries Bhd. On the Basis of a Settlement Agreement (February 22,2008).) 

On March 10,2008, the Court found respondent Yee Lee Corporation Bhd. in default. 

(See Order No. 61 .) The Commission determined not to review the order. (See Notice of 

Commission Decision Not To Review an Initial Determination Finding Respondent Yee Lee 

Corporation Bhd, in Default (March 28,2008).) 

On May 6,2008, the Court found that Tillotson had satisfied the economic prong of the 

domestic industry requirement. (See Order No. 79.) The Commission determined not to review 

the order. (See Notice of Commission Decision Not to Review an Initial Determination Granting 

a Motion for Summary Determination That Economic Prong of the Domestic Industry 

Requirement Has Been Met (May 30,2008.).) 

On May 19,2008, the Court issued an initial determination terminating respondent Darby 

Group Companies, Inc. from the investigation based on consent order. (See Order No. 87.) The 

Commission determined not to review the order. (See Notice of Commission Decision Not To 

Review an Initial Determination Terminating the Investigation With Respect to Respondent 

Darby Group Companies, Inc. Based On Consent Order (July 7,2008).) 

The evidentiary hearing on the question of violation of section 337 commenced on May 

19,2008, and concluded on May 27,2008. Tillotson; Cardinal Health Inc., Cardinal Health 200, 

Inc. and Cardinal Health Malaysia 21 1 Sdn. Bhd (collectively “Cardinal Health”); Ansell 

6 
PUBLIC VERSION 

Limited, Ansell (Thailand) Ltd., Ansell Healthcare Products LLC, and Ansell Protective 

Products Inc. ( collectively “Ansell”); Hartelega Holdings Bhd., Hartelega Sdn. Bhd. and 

Phamtex U.S.A. Inc. (collectively “Hartelega”); JDA (Tianjin) Plastic Rubber Co., Ltd. (“JDA”); 

Kossan Rubber Industries Bhd, Kossan Gloves d/b/a Sintex, and Perusahaan Getah Asas Sdn. 

Bhd. (collectively “Kossan”); PT Shamrock Manufacturing Corporation and PT Haloni Jane 

(collectively “PT Shamrock”); PT Medisafe Technologies (“PT Medisafe”); Riverstone 

Resources Sdn. Bhd. (“Riverstone”); Top Glove Corporation Bhd., Top Glove Sdn. Bhd., and 

TG Medical (U.S.A.), Inc. (collectively “Top Glove”); YTY Holdings Sdn. Bhd. and YTY 

Industry (Manjung) Sdn. Bhd. (collectively “YTY”); Dynarex Corporation (“Dynarex”); 

Protective Industrial Products (“PIP”); Smart Glove Holdings, Sdn. Bhd. and Smart Glove 

Corporation Sdn. Bhd. (collectively “Smart Glove”); Henry Schein, Inc. and HSI Gloves, Inc. 

(collectively “Henry Schein”); Laglove (M) Sdn. Bhd.; and Staff, were represented at the hearing. 

(Hearing Tr. 1 : 1-6:8.) 

On June 19,2008, the Court found respondent Medtexx Partners, Inc. in default. (See 

Order No. 88.) The Commission determined not to review the order. (See Notice of 

Commission Decision Not To Review an Initial Determination Finding Respondent Medtexx 

Partners, Inc. in Default (July 1 1,2008).) 

On June 30,2008, the Court issued an initial determination terminating respondent 

Tronex International, Inc. from the investigation based on settlement agreement. (See Order No. 

89.) The Commission determined not to review the order. (See Notice of Commission Decision 

Not To Review an Initial Determination Terminating the Investigation With Respect to 

Respondent Tronex International, Inc. On the Basis of a Settlement Agreement (July 18,2008).) 
PUBLIC VERSION 

On July 23,2008, Court issued an initial determination terminating respondent Dynarex 

Corporation from this investigation based on settlement agreement. (See Order No. 91 .) The 

Commission determined not to review the order. (See Notice of Commission Decision Not To 

Review an Initial Determination Terminating the Investigation With Respect to Respondent 

Dynarex Corporation Based on Settlement Agreement (August 8,2008).) 

On August 1,2008, the Court found respondent Dash Medical Gloves, Inc. in default. 

(See Order No. 92.) The Commission determined not to review the order. (See Notice of 

Commission Decision Not To Review an Initial Determination Finding Respondent Dash 

Medical Gloves, Inc. in Default (August 20,2008).) 

B. TheParties 

1. Tillotson Corporation 

Tillotson Corporation designed, developed, and manufactured hand protection products, 

including nitrile hand gloves. (Am. Complaint, lfl 1 1-1 3.) On or about October 1,2007, 

Tillotson sold its Best Manufacturing operations and all subsidiaries to Showa Glove Co., which 

resulted in Showa’s subsidiary, Best Glove Inc. (“Best Glove”), acquiring Tillotson’s 

manufacturing operations and facilities in Fayette, Alabama, and Menlo, Georgia. As part of this 

transaction, Tillotson retained its corporate headquarters in Lexington, Massachusetts, and 

ownership of the ‘616 Patent, which it licensed to Best Glove. After the sale, Best Glove has 

continued to manufacture nitrile gloves at the Fayette facility and it maintains the Menlo 

manufacturing headquarters. (CX-788C (Tillotson Direct) at Q&A 159- 172; (CX-790C (Groce 

Direct) at Q&A 7- 17). 

8 
PUBLIC VERSION 

2. Ansell Respondents 

Ansell Ltd. (“Ansell”) is an Australian entity that is allegedly engaged in the manufacture, 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 7 16.) ’ 

Ansell (Thailand) Ltd. is a wholly-owned subsidiary of Ansell, which is allegedly 

engaged in the manufacture, importation, offer for sale after importation, sale and/or use after 

importation into the United States of gloves that infringe certain claims of the ‘61 6 Patent. (Am. 

Complaint, 7 18,30.) 

Ansell Healthcare Products, LLC (New Jersey) is a wholly-owned subsidiary of Ansell, 

which is allegedly engaged in the importation, offer for sale after importation, sale and/or use 

after importation into the United States of gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 7 26,3 1-32.) 

Ansell Protective Products, Inc. (New Jersey) is a wholly-owned subsidiary of Ansell, 

which is allegedly engaged in the importation, offer for sale after importation, sale and/or use 

after importation into the United States of gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 7 25,33.) 

3. Top Glove Respondents 

Top Glove Corporation Bhd. (“Top Glove”) is a Malaysian entity that is allegedly 

engaged in the manufacture, importation, sale for importation, offer for sale after importation, 

sale and/or use after importation into the United States of nitrile gloves that infringe certain 

claims of the ‘616 Patent. (Am. Complaint, 7 34-36.) 

’ “Am. Complaint” refers to the Amended Complaint in Inv. No. 337-TA-608. “Complaint” refers to the 

Complaint in Inv. No. 337-TA-612. 

9 
PUBLIC VERSION 

Top Glove Sdn. Bhd. (Malaysia) is a wholly-owned subsidiary of Top Glove which is 

allegedly engaged in the manufacture, importation, offer for sale after importation, sale and/or 

use after importation into the United States of gloves that infiinge certain claims of the ‘616 

patent. (Am. Complaint, 7 35-36,45-46.) 

TG Medical (USA) Inc. (California) is a wholly-owned subsidiary of Top Glove which 

is allegedly engaged in the importation, offer for sale after importation, sale and/or use after 

importation into the United States of gloves that infringe certain claims of the ‘616 Patent. (Am. 

Complaint, 7 43-44,47-48.) 

4. Hartalega Respondents 

Hartalega Holdings Bhd. (“Hartalega”) is a Malaysian entity that is allegedly engaged 

in the manufacture, importation, sale for importation, offer for sale after importation, sale and/or 

use after importation into the United States of nitrile gloves that infringe certain claims of the 

‘616 Patent. (Am. Complaint, 7 49.) 

Hartalega Sdn. Bhd. (Malaysia) is a wholly-owned subsidiary of Hartalega that is 

allegedly engaged in the manufacture, importation, offer for sale after importation, sale and/or 

use after importation into the United States of gloves that infringe certain claims of the ‘61 6 

Patent. (Am. Complaint, 7 50-52, 55-57.) 

Pharmatex USA, Inc. (California) is a wholly-owned subsidiary of Hartalega that is 

allegedly engaged in the importation, offer for sale after importation, sale and/or use after 

importation into the United States of gloves that infiinge certain claims of the ‘616 Patent. (Am. 

Complaint, 7 53-54,58.) 

5. Kossan Respondents 

Kossan Rubber Industries Bhd. (“Kossan Rubber”) is a Malaysian entity that is 

10 
PUBLIC VERSION 

allegedly engaged in the manufacture, importation, sale for importation, offer for sale after 

importation, sale and/or use after importation into the United States of nitrile gloves that infringe 

certain claims of the ‘616 Patent. (Am. Complaint, 760.) 

Perusahaan Getah Asas Sdn. Bhd. (Malaysia) is a wholly-owned subsidiary of Kossan 

Rubber that is allegedly engaged in the manufacture, importation, offer for sale after importation, 

sale and/or use after importation into the United States of gloves that infringe certain claims of 

the ‘616 Patent. (Am. Complaint, 7 63-65,69-71.) 

Kossan Gloves Inc. d/b/a Sintex (Texas) is a wholly-owned subsidiary of Kossan 

Rubber that is allegedly engaged in the importation, offer for sale after importation, sale and/or 

use after importation into the United States of gloves that infringe certain claims of the ‘6 16 

patent. (Am. Complaint, 7 72 .) 

6. PT Shamrock Respondents 

PT Shamrock Manufacturing Corporation (“PT Shamrock”) is an Indonesian entity 

that is allegedly engaged in the manufacture, importation, sale for importation, offer for sale after 

importation, sale and/or use after importation into the United States of nitrile gloves that infringe 

certain claims of the ‘616 Patent. (Am. Complaint, 7 73-74.) 

PT Haloni Jane (Indonesia) is under common control with PT Shamrock. PT Haloni 

Jane is allegedly engaged in the manufacture, importation, offer for sale after importation, sale 

and/or use after importation into the United States of gloves that infringe certain claims of the 

‘616 Patent. (Am. Complaint, 7 75, 84.) 

Shamrock Manufacturing Company, Inc. (California) is under common control with 

PT Shamrock. Shamrock Manufacturing Company Inc. is allegedly engaged in the, importation, 

offer for sale after importation, sale and/or use after importation into the United States of gloves 

I1 
PUBLIC VERSION 

that infringe certain claims of the ‘616 Patent. (Am:Complaint, fi 77-79, 85-87.) 

7. Smart Glove Respondents 

Smart Glove Holdings Sdn. Bhd. (“Smart Glove”) is a Malaysian entity that is allegedly 

engaged in the manufacture, importation, sale for importation, offer for sale after importation, 

sale and/or use after importation into the United States of nitrile gloves that infringe certain 

claims of the ‘616 Patent. (Am. Complaint, fi 88.) 

Smart Glove Corporation Sdn. Bhd (Malaysia) is a wholly-owned subsidiary of Smart 

Glove that is allegedly engaged in the manufacture, importation, offer for sale after importation, 

sale and/or use after importation into the United States of gloves that infringe certain claims of 

the ‘616 Patent. (Am. Complaint, fi 89-91, 100-102.) 

8. YTY Respondents 

YTY Holdings Sdn. Bhd. (“YTY”) is a Malaysian entity that is allegedly engaged in the 

manufacture, importation, sale for importation, offer for sale after importation, sale and/or use 

after importation into the United States of nitrile gloves that infringe certain claims of the ‘616 

patent. (Am. Complaint, fi 103.) 

YTY Industry (Manjung) Sdn. Bhd. (Malaysia) is a subsidiary of YTY that is allegedly 

engaged in the manufacture, importation, offer for sale after importation, sale and/or use after 

importation into the United States of gloves that infringe certain claims of the ‘616 Patent. (Am. 

Complaint, fl 109- 1 10.) 

9. Delta 

Delta Medical Systems, Inc. (“Delta Medical”) of Georgia is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘6 16 Patent. 

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PUBLIC VERSION 

(Am. Complaint, 7 1 1 1 .) 

10. JDA (Tianjin) 

JDA (Tianjin) Plastic Rubber Co. Ltd. (“JDA”) is a Chinese entity that is allegedly 

engaged in the manufacture, importation, sale for importation, offer for sale after importation, 

sale and/or use after importation into the United States of nitrile gloves that infringe certain 

claims of the ‘6 16 Patent. (Am. Complaint, 7 120-2 1 .) 

11. Laglove 

Laglove (M) Sdn. Bhd. (“Laglove”) is a Malaysian entity that is allegedly engaged in 

the manufacture, importation, sale for importation, offer for sale after importation, sale and/or 

use after importation into the United States of nitrile gloves that infringe certain claims of the 

‘616 Patent. (Am. Complaint, 7 122-23.) 

12. PT MediSafe 

PT MediSafe Technologies (“PT MediSafe”) is an Indonesian entity that is allegedly 

engaged in the manufacture, importation, sale for importation, offer for sale after importation, 

sale and/or use after importation into the United States of nitrile gloves that infringe certain 

claims of the ‘616 Patent. (Am. Complaint, 7 124.) 

13. Riverstone 

Riverstone Resources Sdn. Bhd. (“Riverstone”) is a Malaysian entity that is allegedly 

engaged in the manufacture, importation, sale for importation, offer for sale after importation, 

sale and/or use after importation into the United States of nitrile gloves that infringe certain 

claims of the ‘616 Patent. (Am. Complaint, 7 125-126.) 

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PUBLIC VERSION 

14. Adenna 

Adenna, Inc. (“Adenna”) of California is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 7 153-156.) 

15. Darby Group 

Darby Group Companies, Inc. (“Darby”) of New York is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 7 160-161.) 

16. Dash 

Dash Medical Gloves, Inc. (“Dash”) of Wisconsin is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 7 166-67.) 

17. Dentexx 

Dentexx/First Medica Infection Control Assoc. (“Dentexx”) of North Carolina is 

allegedly engaged in the importation, sale for importation, offer for sale after importation, sale 

and/or use after importation into the United States of nitrile gloves that infringe certain claims of 

the ‘61 6 Patent. (Am. Complaint, 7 170.) 

18. Dynarex 

Dynarex Corp (“Dynarex”) of New York is allegedly engaged in the importation, sale 

for importation, offer for sale after importation, sale and/or use after importation into the United 

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PUBLIC VERSION 

States of nitrile gloves that infringe certain claims of the ‘61 6 Patent. (Am. Complaint, fi 171- 

172.) 

19. Liberty Glove 

Liberty Glove and Safety Co. (“Liberty Glove”) of California is allegedly engaged in 

the importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that idtinge certain claims of the ‘616 Patent. 

(Am. Complaint, fi 176-1 77.) 

20. Protective Industrial Products 

Protective Industrial Products, Inc. (,‘PIP”) of New York is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, 1180-1 8 1 -) 

21. QRP 

QRP, Inc. D/b/a GRP Gloves Inc. (“QRP”) of Arizona is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘616 Patent. 

(Am. Complaint, fi 182-83.) 

22. Tronex 

Tronex International, Inc. (“Tronex”) of New Jersey is allegedly engaged in the 

importation, sale for importation, offer for sale after importation, sale and/or use after 

importation into the United States of nitrile gloves that infringe certain claims of the ‘61 6 Patent. 

(Am. Complaint, fi 184-85.) 

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PUBLIC VERSION 

23. Cardinal Health Respondents 

Cardinal Health, Inc. (“Cardinal Health”) of Ohio, purportedly the parent corporation of 

Cardinal Health 200 Inc. and Cardinal Health Malaysia 21 1 Sdn. Bhd., allegedly manufactures 

abroad, imports into, and sells in the United States, either alone or through its subsidiaries, nitrile 

rubber gloves that infringe certain claims of the ‘616 Patent. (Complaint 1 8,11 35-37.) 

Cardinal Health 200 Inc. (Illinois) is allegedly a wholly-owned subsidiary of Cardinal 

Health and purportedly imports into and sells in the United States nitrile rubber gloves that 

infringe certain claims of the ‘616 Patent. (Complaint 1 9, 11 38-39.) 

Cardinal Health Malaysia 21 1 Sdn. Bhd. is a Malaysian entity and a foreign subsidiary of 

Cardinal Health, Inc., which purportedly imports into and sells in the United States nitrile rubber 

gloves that infringe certain claims of the ‘616 Patent. (Complaint 1 10,140.) 

24. Henry Schein Respondents 

Henry Schein, Inc. (“Henry Schein”) of New York, purportedly the parent corporation of 

HSI Gloves, Inc., allegedly imports into and sells in the United States, either alone or through its 

subsidiaries, nitrile rubber gloves that infringe certain claims of the ‘61 6 Patent. (Complaint 1 1 1, 

1 41.) 

HSI Gloves, Inc. of Melville, New York, allegedly a wholly-owned subsidiary of Henry 

Schein, Inc., purportedly imports into and sells in the United States nitrile rubber gloves that 

infringe certain claims of the ‘616 Patent. (Complaint 1 12,1 42.) 

25. Latexx Partners 

Latexx Partners Berhad is a Malaysian entity that allegedly manufactures abroad, imports 

into, and sells in the United States through its subsidiaries nitrile rubber gloves that infringe 

certain claims of the ‘616 Patent. (complaint 7 13, 7143-44.) 

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PUBLIC VERSION 

26. Medtexx Partners, Inc. 

Medtexx Partners, Inc. (New Jersey) purportedly imports into and sells in the United 

States nitrile rubber gloves that infringe certain claims of the ‘616 Patent. (Complaint 7 14,y 45.) 

Some of the respondents listed above have been terminated from the investigation based 

on settlement agreement and/or consent order or have been found in default. (See supra Section 

I.A.) The remaining respondents are Adenna, Inc. (“Adenna”); Ansell, Ltd., Ansell (Thailand) 

Ltd., Ansell Healthcare Products LLC (collectively “An~ell~’); Cardinal Health, Inc., Cardinal 

Health 200, Inc., Cardinal Health Malaysia 21 1 Sdn. Bhd. (collectively “Cardinal Health”); 

Hartalega Holdings Bhd., Hartalega Sdn. Bhd., JDA (Tianjin) Plastic Rubber Co. Ltd., Kossan 

Gloves Inc. d/b/a Sintex, Kossan Rubber Industries Bhd., Laglove (M) Sdn. Bhd., Latexx 

Partners Berhad, Perusahaan Getah Asas Sdn. Bhd., Pharmatex USA Inc., PT Haloni Jane, PT 

Medisafe Technologies, PT Shamrock Manufacturing Corporation, Riverstone Resources Sdn. 

Bhd., Shamrock Manufacturing Company Inc., TG Medical (USA) Inc., Top Glove Corporation 

Bhd., Top Glove Sdn. Bhd., YTY Holdings Sdn. Bhd., and YTY Industry (Manjung) Sdn. Bhd. 

(collectively “the K&E Respondents”); Henry Schein, Inc. and HIS Gloves Inc. (collectively 

“Henry Schein”); Liberty Glove, Inc. d/b/a Liberty Glove and Safety Co.; Protective Industrial 

Products, Inc.; QRP, Inc. d/b/a QRP Glove, Inc.; and Smart Glove Holdings Sdn. Bhd. and Smart 

Glove Corporation Sdn. Bhd. (collectively “Smart Glove”) (collectively “Respondents”). 

C. Overview of the Technology 

The products at issue are nitrile rubber gloves. (Am. Complaint, 1 188.) These nitrile 

rubber gloves are made from a nitrile butadiene latex rubber elastomeric material, are 

substantially impermeable to water vapor and liquid water, and have a relatively high tensile 

strength. (Am. Complaint, 77 188- 190.) 

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PUBLIC VERSION 

D. The Patent At Issue 

This investigation pertains to US. Patent No. Re. 35,616 (“the ‘616 Patent”), entitled 

“Elastomeric Covering Material and Hand Gloves Made Therewith,” which is a reissue of U.S. 

Patent No. 5,014,362 (“the ‘362 Patent”). The ‘362 Patent was filed on May 11, 1990, and 

issued on May 14, 1991. (See JX-1 (‘362 Patent)). On November 13,1995 Mr. Tillotson and 

Tillotson Corporation filed a reissue patent application, which resulted in the ‘6 16 Patent now at 

issue in these investigations. The ‘616 Patent issued on September 30, 1997. (See JX-3 (‘616 

Patent)). 

The asserted claims of the ‘6 16 Patent in these investigations are claims 1, 17- 19. 

Claim 1 reads as follows: 

1. A closelyfitting glove comprising a layer of elastomeric material (a) 

comprising nitrile butadiene rubber, (b) having an initial configuration adapted to 

receive andfit closely about a hand and (c) characterized by (I, being 

substantially impermeable to water vapor and liquid water, (iI, having a tensile 

strength of at least about 1500 psi as measured according to ASTM D-4 12 on a 

sample of the elastomeric material having a thickness from about 4.0 to about 4.5 

mils, and (iii) having a thickness and elastic properties such that the glove is 

capable of being stretched tofit closely about the hand and when stretched from 

the initial configuration to fit closely about the hand, the elastomeric material 

conforms to the configuration of the hand initially exerting [a predetemined] an 

initial pressure on the hand and thereafter stillfitting closely about the hand, but 

relaxing, within about 6 minutes after the gloves is stretched to fit about said hand, 

to exert on the hand a reduced pressure which is [substantially] less than about 

[80%] 50% of the [predetermined] initial pressure. 

Claims 17, 18 and 19 read as follows: 

17. A glove as in Claim 1, wherein the layer of elastomeric material has a 

thickness up to about 4.5 mils. 

18. A glove as in Claim 1 wherein the layer of elastomeric materila has a 

thicknessfiom about 4 to about 4.5 mils. 

19. A glove as in Claim 1, therein the layer of elastomeric material is further 

characterized by having an elongation of greater than about 800 lbs/in. 

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PUBLIC VERSION 

(Id. at 6:33-50, 8:9-15) (emphasis in original). The ‘616 Patent names Mr. Neil Tillotson and Mr. 

Luc DeBecker as the inventors. (Id.) 

The ‘6 16 Patent discloses a closely-fitting latex glove made of nitrile rubber having the 

initial shape of a hand. The ‘61 6 Patent further discloses a glove that is impermeable to water, 

has a tensile strength of at least about 1500 psi, and is capable of being stretched to fit on the 

hand of a wearer as the glove is donned. (JX-3 at 2:6-21 (‘616 Patent).) The ‘616 Patent 

discloses a glove that exerts an initial pressure on the hand when the glove is donned and then 

relaxes within a few minutes to substantially reduce the pressure on the hand while retaining a 

close fit. (Id.) Claim 1 is the only independent claim. The remaining claims at issue, claims 17- 

19, depend directly from claim 1. The ‘6 16 Patent is assigned and owned by Tillotson. (Am. 

Complaint, fl 199; Complaint Ex. 2.) 

E. The Products At Issue 

The products at issue in this investigation are nitrile gloves. The accused products are 

listed by respondent(s) in Appendix B. 

11. IMPORTATION OR SALE 

The importation or sale requirement of section 337 has not been contested. (RIB at 6.) 

Thus, it is found that Respondents sell for importation, import and, or, sells after importation 

articles accused in this investigation. The importation or sale requirement of section 337 is 

satisfied. (CX-162; CX-235C; CX-238C; CX-264C;CX-308C; CX-456C; CX-457C; CX-458C; 

CX-46OC;CX-46 1 C; CX-462C; CX-463C; CX-464C; CX-465C; CX-466C; CX-467C; CX-468C; 

CX-785C; CX-789C at Q&A 166-78, 190-206,210-15,217-23,270-76,230-43,263-76; CX19 
PUBLIC VERSION 

939C; CX-943C; CX-946C; CX-947C; CX-948C; CX-949C;CX-95OC; ROCFF IV. 1 1-501 ; 

ROSFF 73-94.) 

1II.CLAIM CONSTRUCTION 

A. Applicable Law 

Pursuant to the Commission’s Notices of Investigation, these consolidated investigations 

are patent-based investigations. See 72 Fed. Reg. 37052,47072 (2007). Accordingly, all of the 

unfair acts alleged by Tillotson to have occurred are instances of alleged infringement of the 

‘6 16 Patent. Any finding of infringement or non-infringement requires a two-step analytical 

approach. First, the asserted patent claims must be construed as a matter of law to determine 

their proper scope.2 Second, a factual determination must be made as to whether the properly 

construed claims read on the accused devices. See Markman v. Westview Instruments, Inc., 52 

F.3d 967,976 (Fed. Cir. 1995)(en banc), aff’d, 517 U.S. 370 (1996). 

Claim construction begins with the language of the claims themselves. Claims should be 

given their ordinary and customary meaning as understood by a person of ordinary skill in the art, 

viewing the claim terms in the context of the entire patent. Phillips v. A WH Corp., 415 F.3d 

1303, 1312-13 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006). With respect to claim 

preambles, the Court of Appeals for the Federal Circuit has explained that: 

[A] Claim preamble has the import that the claim as a whole suggests for it. In 

other words, when the claim drafter chooses to use both the preamble and the 

body to define the subject matter of the claimed invention, the invention so 

defined, and not some other, is the one the patent protects. 

Only those claim terms that are in controversy need to be construed, and only to the extent necessary to resolve 2 

the controversy. Vanderlande Indus. NederlandBVv. Int’l Trade Comm., 366 F.3d 131 1, 1323 (Fed. Cir. 2004); 

Vivid Tech., Inc. v. American Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). 

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PUBLIC VERSION 

Eaton Corp. v. Rockwell Int ’I Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) (quoting Bell 

Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 61 5,620 (Fed. Cir. 

1995)). 

In some instances, claim terms do not have particular meaning in a field of art, and claim 

construction involves little more than the application of the widely accepted meaning of 

commonly understood words. Phillips, 41 5 F.3d at 13 14. In such circumstances, general 

purpose dictionaries may be helpful. In many cases, claim terms have a specialized meaning, 

and it is necessary to determine what a person of skill in the art would have understood disputed 

claim language to mean, by analyzing the words of the claims themselves, the remainder of the 

specification, the prosecution history, and extrinsic evidence concerning relevant scientific 

principles, as well as the meaning of technical terms, and the state of the art. Id. (quoting 

InnovdPure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1 1 1 1, 1 1 16 (Fed. Cir. 

2004)). 

In cases in which the meaning of a claim term is uncertain, the specification usually is the 

best guide to the meaning of the term. Id. at 13 15. As a general rule, the particular examples or 

embodiments discussed in the specification are not to be read into the claims as limitations. 

Markman, 52 F.3d at 979. However, the specification is always highly relevant to the claim 

construction analysis. The specification is usually dispositive. It is the single best guide to the 

meaning of a disputed term. Phillips, 41 5 F.3d at 13 15. Moreover, “[tlhe construction that stays 

true to the claim language and most naturally aligns with the patent’s description of the invention 

will be, in the end, the correct construction.” Id. at 13 16. 

If the intrinsic evidence does not establish the meaning of a claim, then extrinsic evidence 

may be considered. Extrinsic evidence consists of all evidence external to the patent and the 

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PUBLIC VERSION 

prosecution history, including inventor testimony, expert testimony and learned treatises. Id. at 

13 17. Inventor testimony can be useful to shed light on the relevant art. In evaluating expert 

testimony, a court should discount any expert testimony that is clearly at odds with the claim 

construction mandated by the claims themselves, the written description, and the prosecution 

history, in other words, with the written record of the patent. Id. at 13 18. Extrinsic evidence 

may be considered if a court deems it helpful in determining the true meaning of language used 

in the patent claims. Id. 

B. The Disputed Claim Terms and Their Proper Construction 

On March 14,2008, the Court issued Order No. 63: Construing the Disputed Terms of 

the Asserted Claims of the Patent at Issue. Order No. 63 is incorporated herein in its entirety. 

1. “Less than about 50%’’ 

In Order No. 63, this Court construed “about 50%’ to mean approximately 50%, which 

literally encompassed values between 45% to 55%. (See Order No. 63 at 41.) The parties now 

dispute the construction of “less than about 50%” 

Respondents argue that “less than about 50%’ “must include only values less than 45%.” 

(RIB at 7-8.) Respondents argue that “[tlo hold otherwise would be contrary to the ordinary 

meaning of ‘less than’ and would broaden the scope of the claim term to read ‘less than or equal 

to about 50% of the initial pressure.” (Id. at 8.) Respondents argue that Tillotson has 

impermissibly read the term “less than” out of claim 1 for those accused gloves whose relaxation 

values fall within 45% to 55%. (Id. at 8.) 

Tillotson argues that relaxation values of less than 55% would fall within the range of 

45% to 55% and meet the limitation of claim 1. (CRB at 1 .) Tillotson further argues that such 

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PUBLIC VERSION 

an interpretation is consistent with how both Respondents’ and Tillotson’s experts applied the 

Court’s claim construction. (Id. at 1 .) Tillotson hrther argues that Respondents’ interpretation 

contradicts the plain language of the claims of the ‘6 16 Patent, file history, and understanding 

and interpretation by one of ordinary skill in the art. (Id. at 1 .) Staff agrees and further argues 

that the Court construed about 50% to encompass values between 45% to 55%, which would 

include values as high as 54%. (SIB at 12, note 20.) 

In response, Respondents argue that since the applicants chose to use the adjectives “less 

than,” then it must exclude values equal to the range of numbers encompassed by “about 50%.” 

(RRB at 3 1-32.) Respondents argue that had the applicants sought to include the matters within 

the range, then the applicants would have used adjectives such as “at least” or “within,” which 

the applicants had used to modify other “about” terms. (Id. at 3 1-32.) 

The Court finds that “less than about 50%’ encompasses values between 45% to 55% and 

is not limited to values that fall below 45%. The Court noted in Order No. 63 that the intrinsic 

evidence supported its construction of “about 50%.” (See Order No. 63 at 4 1-42.) The intrinsic 

evidence further supports the Court’s findings in this instance. Claim 13 of the original reissue 

application also uses the terms “less than about 50%”: 

A glove as in Claim 1, further characterized by having elastomeric properties such 

that the reduced pressure is less than about 50% of said predetermined pressure. 

(JX-4 at TLC000013 (‘616 Prosecution History)) (emphasis added.) In rejecting Claim 13 in the 

original reissue application, the examiner stated that “the value of 54%’ which was reached with 

the 5 mil sample, is sufficiently close to meet a limitation of “about 50%” such as in Claim 13.” 

(Id. at TLCOO153-154.) Thus, the examiner found that the value of 54% was sufficient to fall 

within the limitation of Claim 13, which is the exact same claim language at issue here. As such, 

to accept Respondents interpretation of “less than about 50%” to be limited to values that are less 

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PUBLIC VERSION 

than 45% would blatantly ignore the prosecution history. Phillips, 41 5 F.3d at 13 17 ("In 

addition to consulting the specification, we have held that a court "should also consider the 

patent's prosecution history, if it is in evidence.") (citations omitted.); see also Graham v. John 

Deere Co., 383 US. 1,33 (1966) ("An invention is construed not only in the light of the claims, 

but also with reference to the file wrapper or prosecution history in the Patent Office."). 

IV. INFRINGEMENT DETERMINATION 

A. Applicable Law 

In a section 337 investigation, the complainant bears the burden of proving infringement 

of the asserted patent claims by a preponderance of the evidence. Certain Flooring Products, 

Inv. No. 337-TA-443, Commission Notice of Final Determination of No Violation of Section 

337,2002 WL 448690 at 59, (March 22,2002); Enercon GrnbHv. Int'l Trade Comm'n, 151 F.3d 

1376 (Fed. Cir. 1998). 

Each patent claim element or limitation is considered material and essential. London v. 

Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991). Literal infringement of a claim 

occurs when every limitation recited in the claim appears in the accused device, i. e., when the 

properly construed claim reads on the accused device exactly. Amhil Enters., Ltd. v. Wawa, Inc., 

81 F.3d 1554, 1562 (Fed. Cir. 1996); Southwall Tech. v. Cardinal IG Co., 54 F.3d 1570, 1575 

(Fed Cir. 1995). 

If the accused product does not literally infringe the patent claim, infringement might be 

found under the doctrine of equivalents. The Supreme Court has described the essential inquiry 

of the doctrine of equivalents analysis in terms of whether the accused product or process 

contains elements identical or equivalent to each claimed element of the patented invention. 

Wurner-Jenkinson Co., Inc. v. Hiddon Davis Chemical Co., 520 U.S. 1 7,40 (1 997). 

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PUBLIC VERSION 

Under the doctrine of equivalents, infringement may be found if the accused product or 

process performs substantially the same function in substantially the same way to obtain 

substantially the same result. Valmont Indus., Inc. v. Reinke Mfg. Co., 983 F.2d 1039, 1043 (Fed. 

Cir. 1993). The doctrine of equivalents does not allow claim limitations to be ignored. Evidence 

must be presented on a limitation-by-limitation basis, and not for the invention as a whole. 

Warner-Jenkinson, 520 U.S. at 29; Hughes Aircraft Co. v. US., 86 F.3d 1566 (Fed. Cir. 1996). 

Thus, if an element is missing or not satisfied, infringement cannot be found under the doctrine 

of equivalents as a matter of law. See, e.g., Wright Medical, 122 F.3d 1440, 1444 (Fed. Cir. 

1997); Dolly, Inc. v. Spalding & Evenflo Cos., Inc., 16 F.3d 394,398 (Fed. Cir. 1994); London v. 

Carson Pirie Scott & Co., 946 F.2d 1534, 1538-39 (Fed. Cir. 1991); Becton Dickinson and Co. v. 

C. R. Bard, Inc., 922 F.2d 792,798 (Fed. Cir. 1990). 

The concept of equivalency cannot embrace a structure that is specifically excluded from 

the scope of the claims. Athletic Alternatives v. Prince Mfg., Inc., 73 F.3d 1573, 1581 (Fed. Cir. 

1996). In applying the doctrine of equivalents, the Commission must be informed by the 

fundamental principle that a patent’s claims define the limits of its protection. See Charles 

Greiner & Co. v. Mari-Med. Mfg., Inc., 92 F.2d 1031, 1036 (Fed. Cir. 1992). As the Supreme 

Court has affirmed: 

Each element contained in a patent claim is deemed material to defining the scope 

of the patented invention, and thus the doctrine of equivalents must be applied to 

individual elements of the claim, not to the invention as a whole. It is important 

to ensure that the application of the doctrine, even as to an individual element, is 

not allowed such broad play as to effectively eliminate that element in its entirety. 

Warner-Jenkinson, 520 U.S. at 29. 

Prosecution history estoppel may bar the patentee from asserting equivalents if the scope 

of the claims has been narrowed by amendment during prosecution. A narrowing amendment 

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PUBLIC VERSION 

may occur when either a preexisting claim limitation is narrowed by amendment, or a new claim 

limitation is added by amendment. These decisions make no distinction between the narrowing 

of a preexisting limitation and the addition of a new limitation. Either amendment will give rise 

to a presumptive estoppel if made for a reason related to patentability. Honeywell Int ’I Inc. v. 

Hamilton Sundstrand Corp., 370 F.3d 1131, 1139-41 (Fed. Cir. 2004), cert. denied, 545 U.S. 

1127 (2005)(citing Warner-Jenkinson, 520 U.S. at 22,33-34; and Festo Corp. v. Shoketsu 

Kinzoku Kogvo Kabushiki Co., 535 US. 722,733-34,741 (2002)). The presumption of estoppel 

may be rebutted if the patentee can demonstrate that: (1) the alleged equivalent would have been 

unforeseeable at the time the narrowing amendment was made; (2) the rationale underlying the 

narrowing amendment bore no more than a tangential relation to the equivalent at issue; or (3) 

there was some other reason suggesting that the patentee could not reasonably have been 

expected to have described the alleged equivalent. Honeywell, 370 F.3d at 1140 (citing, inter 

alia, Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359 (Fed. Cir. 2003)(en 

banc)). 

B. Analysis of the Accused ProductsError! Bookmark not defined. 

1. Claim 1 

Tillotson has accused Respondents of infringement of independent claim 1 and dependent 

claims 17- 19 of the ‘6 16 Patent by the importation, the sale for importation or the sale after 

importation of nitrile gloves in the United States. 

a) Literal Infringement 

Tillotson argues that the gloves identified in Table A attached to its post-hearing brief 

meet all of the limitations of claim 1 of the ‘616 Patent. The gloves identified in CX-33, CX-80 

and CX-802 were evaluated to determine whether they met the limitations of the asserted claims 

26 
PUBLIC VERSION 

of the ‘616 Patent. (CX-786C at Q&A 34-41 (Moalli Direct).) Specifically, the gloves were 

tested to evaluate the fit of the glove, composition, water and water vapor permeability, tensile 

strength, stress relaxation, thickness and puncture resistance. (Id. at Q&A 34.) Tillotson 

presented its conclusions on each of the limitations in CX34-50, CX-8 1-90 and CX-803-805. (Id. 

at Q&A 123-128.) The column headings and associated footnotes all refer to specific limitations 

of claim 1. (Id. at Q&A 129.) Each glove is identified by the respondent, a description of the 

glove and assigned an identification number by Tillotson’s expert, Dr. John E. Moalli. (Id. at 

Q&A 130.) If the glove meets the specific limitation, then an affirmative response (Y) is placed 

in that column. (Id. at Q&A 13 1 and 135.) If a claim limitation is not met, then a negative 

response (N) is place in that column. ( Id. at Q&A 13 1 .) If a certain parameter was not tested, 

then an “NIX’ is placed in that column. (Id. at Q&A 134.) This identification and determination 

are consistent for all of the gloves listed in CX34-50, CX-8 1-90 and CX-803-805. (Id. at Q&A 

136- 139.) 

(1) A closely fitting glove; an initial configuration adapted to receive 

andfit closely about a hand; and a thickness and elastic properties such 

that the glove is capable of being stretched to fit closely about the hand 

and when stretched from the initial configuration to fit closely about the 

hand 

In order to evaluate whether the gloves were met these closely fitting limitations of Claim 

1, Dr. Moalli, conducted a “fit test” by performing a visual inspection of the glove and donning 

the glove: 

Analysis of “having an initial configuration adapted to receive and fit closely 

about the hand” was initially assessed by visual inspection of the glove geometry 

and verified by hand insertion. Analysis of “closely fitting” and “fitting closely” 

was also performed by hand insertion (and subsequently wearing the glove for at 

least 7 minutes) and noting whether or not the glove followed the contours of, and 

generally conformed to, the hand; it was determined by tactile means if the glove 

exerted an initial preswre on the hand at this time as well. Finally, “thickness and 

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PUBLIC VERSION 

elastic properties such that the glove is capable of being stretched to fit closely 

about the hand” was also evaluated during hand insertion by observation of the 

ability to stretch the glove such that it fit closely while donning it. 

(CX-786C at Q&A 44 (Moalli Direct).) If the gloves met these limitations, then a “I”’ is placed 

in the columns labeled “Closely Fitting,” “Initial Configuration,’’ “Capable of Being Stretched to 

Fit Closely,” and “Exerts an Initial Pressure.” (Id. at Q&A 140-148 and 190-202; CX-34-50, 

CX-81-90, and CX-803-805.) 

The parties do not dispute that Respondents’ gloves meet certain of the limitations of 

Claim 1 ofthe ‘616 Patent. (CIB at 21-22; RIB at 67-88; SIB at 10-1 1. CX-106-183C; CX-241; 

CX-460-468C; CX-908C; CX-238C;CX-235C; CX-457-458C; CX-785C.) Respondents do not 

argue that its gloves fail to satis@ the limitations “closely fitting,” to “have an initial 

configuration adapted to receive and fir closely about a hand,” to “have a thickness and elastic 

properties such that the glove is capable of being stretched to fit closely about the hand”, and 

when so stretched to “conform[] to the configuration of the hand, initially exerting an initial 

pressure on the hand.” (FUZCPFF V.B.43; ROCPFF V.B.43-816; CX-33, CX-80, CX-802; CX34-50, CX-8 1-90, CX-803-805; CX-786C at Q&A 42-47 (Moalli Direct).) Staff also does not 

dispute that Respondents’ gloves meet this limitation. (SIB at 1 1 .) 

The Court finds that the evidence shows that Respondents’ tested gloves elastically 

conform to the shape of the hand when stretched to fit the hand. (CX-34-50; CX-81-90 and CX803-805; CPX 2-55; CPX 57-78; CPX 80-172; CPX 193-217.) Therefore, the Court finds that 

all of Respondents’ gloves listed in CX-34-50, CX-8 1-90 and CX-803-805 with a “Y” in the 

column labeled “Closely Fitting,” “Initial Configuration,’’ “Capable of Being Stretched to Fit 

Closely,” and “Exerts an Initial Pressure” meet the limitations of claim 1 of the ‘61 6 Patent that 

require “a closely fitting glove;” “an initial configuration adapted to receive and fit closely about 

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PUBLIC VERSION 

a hand;” and “a thickness and elastic properties such that the glove is capable of being stretched 

to fit closely about the hand and when stretched from the initial configuration to fit closely about 

the hand.” (CX-34-50, CX-81-90 and CX-803-805.) 

(2) Comprising nitrile butadiene rubber 

In order to determine the composition of the gloves, Dr. Moalli used a Fourier Transform 

Infrared Spectrometer (“FTIR”). (CX-786 C at Q&A 49-50 (Moalli Direct).) The FTIR allowed 

Dr. Moalli to determine whether there was a nitrile peak in the FTIR spectra for each sample and, 

therefore, determine whether the glove was made from nitrile. (Id. at Q&A 5 1 .) The FTIR data 

for each of the tested gloves is listed in CX-68; CX-75; CX-102 and CX 809. (Id. at Q&A 52- 

56.) Dr. Moalli determined that if the peak in the graph was about 2240 wave numbers, then it is 

indicative of nitrile and a layer of elastomeric material comprised of nitrile rubber. (Id. at Q&A 

15 1-1 56.) Thus, if the glove met this limitation of being comprised of nitrile butadiene rubber, 

then a “Y” is placed in the column labeled “NBR Rubber.” (Id. at Q&A 149-1 59 and 190-202; 

CX-34-50, CX-81-90, and CX-803-805.) 

Respondents do not dispute that its gloves comprise a layer of elastomeric material 

comprising nitrile butadiene rubber. (RROCPFF-V.B.825; 826-1008; CIB at 21-22; RIB at 67- 

88.) Staff also does not dispute that Respondents’ gloves meet this limitation. (SIB at 1 1 .) 

The Court finds that, with the exception of the Ambi-Gard Pre-Powdered Nitrile Exam 

Gloves Surgi-Grip Textured Finish and Ambi-Gard Powder-Free Nitrile Exam Gloves SurgiGrip Textured Finish gloves (see CX-43 (“N” under column labeled “NBR Rubber”), the 

evidence shows that respondents gloves listed in CX-34-50, CX-81-90 and CX-803-805 with a 

“Y” in the column labeled “NBR Rubber” are comprised of nitrile butadiene rubber. (CX-34-50; 

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PUBLIC VERSION 

CX-81-90 and CX-803-805.) Therefore, the Court finds that those gloves listed meet the claim 

limitation of being comprised of nitrile butadiene rubber. 

(3) Being substantially impermeable to water vapor and liquid water 

In order to determine whether the glove was impermeable to liquid water and water vapor, 

Dr Moalli designed a test setup that would measure the amount of weight loss from a portion of a 

finger excised from each glove and filled with water over the course of a four hour period. (CX786C at Q&A 57-60 (Moalli Direct).) He recorded the data gathered from this test in CX-69, 

CX-76, CX- 103 and CX-8 10. (Id. at Q&A 6 1-66.) Thus, if the glove met this limitation of 

being impermeable to water vapor and liquid water, then a “Y” is placed in the column labeled 

“Impermeable to Water Vapor.” (Id. at Q&A 13 1-1 39, 161 -169 and 190-202; CX-34-50, CX81-90, and CX-803-805.) 

Respondents do not dispute that its gloves are substantially impermeable to water vapor 

and liquid water. (ROCPFF V.B.1453-1644; CIB at 21-22; RIB at 67-88.) Staff also does not 

dispute that Respondents’ gloves meet this limitation. (SIB at 1 1 .) 

The Court finds that the evidence shows that Respondents’ gloves listed in CX-34-50, 

CX-8 1-90 and CX-803-805 with a “Y” in the column labeled “Impermeable to Water Vapor” are 

impermeable to liquid water and water vapor and, therefore, meet the claim limitation of being 

“substantially impermeable to water vapor and liquid water.” (CX-34-50, CX-8 1-90, and CX803-805.) 

(4) Having a tensile strength of at least about 15OOpsi as measured 

according to ASTM 0-412 on a sample of the elastomeric material 

having a thickness from about 4.0 to about 4.5 mils 

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PUBLIC VERSION 

In order to determine the glove’s tensile strength, Dr. Moalli performed the test in 

accordance with ASTM D-412. (CX-786 C at Q&A 79-81 (Moalli Direct).) Dr. Moalli created 

a dog bone shaped, also known as dumbbell shaped, sample from each glove using a punch die 

that was certified to the Type C dimensions of ASTM D-412 and had a thickness of 3.5 to 5.0 

mils. (Id. at Q&A 74-78; 87.) To measure the thickness of the glove samples for purposes of 

testing tensile strength, stress relaxation and puncture resistance, Dr. Moalli measured the 

thickness of the gloves using a Mitutoyo Model 7326 flat anvil-type dial thickness gauge. (Id. at 

Q&A 67-71 .) (See inpa part B.2.a.i) The sample was then conditioned pursuant to the ASTM 

D-4 12 standard and placed in an Instron mechanical testing machine to evaluate the tensile 

strength of the accused gloves. (Id. at Q&A 82-84.) The Instron machine was programmed in 

accordance with ASTM D-4 12 standards, which allowed Dr. Moalli to evaluate the tensile 

strength of the sample. (Id. at Q&A 85-88.) The data collected by Dr. Moalli is set forth in CX71; CX-78; CX-105 and CX-812. (Id. Q&A 89-93.) Thus, if the glove met this limitation of 

having a tensile strength of at least 1500 psi, then a “Y” is placed in the column labeled “Tensile 

strength of at least 1,500 psi.” (Id. at Q&A 131-139, 182-189 and 190-202; CX-34-50, CX-81- 

90, and CX-803-805.) 

For those samples from which Dr. Moalli could not obtain sample that had a thickness 

from 3.5 to 5.0 mils, Dr. Moalli still evaluated the sample in accordance with ASTM D-412. 

(CX-786 C at Q&A 203-204 (Moalli Direct).) He recorded the data in CX-91 and CX-51 and 

concluded that “if the measured value is at least about 1,500 psi, and the thickness of the sample 

is greater than 5.0 mils, the sample of the elastomeric material will more likely than not have a 

tensile strength of at least 1,500 psi.” (Id. at Q&A 205-207.) Dr. Moalli bases his conclusion on 

the fact that “tensile strength often goes down with increased thickness,” so if samples have a 

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PUBLIC VERSION 

thickness greater than 5.0 mils and it meets the tensile strength limitation, then it unlikely that a 

thinner sample would fail to meet the limitation as well. (Id. at Q&A 208-209.) 

Respondents do not dispute that its gloves have a tensile strength of at least 1500 psi as 

measured on a sample of elastomeric material with a thickness of about 4.0 to 4.5 mils. 

(ROCPFF-V.B. 1039-122 1 .) Staff also does not dispute that Respondents gloves meet this 

limitation. (SIB at 1 1 .) 

The Court finds that the evidence shows that all of Respondents’ gloves from which Dr. 

Moalli could obtain an sample of elastomeric material with a thickness of 3.5 to 5.0 mils had a 

tensile strength of at least 1400-1600 psi, e.g. those listed in CX-34-50, CX-81-90, and CX-803- 

805 with a “Y” under the column labeled “Tensile strength of at least 1500 psi” and, therefore, 

meet the claim limitation of “having a tensile strength of at least 1500 psi as measured on a 

sample of elastomeric material with a thickness of about 4.0 to 4.5 mils.” (CX-34-50, CX-8 1-90, 

and CX-803-805.) 

For those samples from which a sample of 3.5 to 5.0 mils could not be obtained, the 

Court finds that Tillotson had failed to meet its burden of proving by a preponderance of the 

evidence that these gloves meet this claim limitation. Dr. Moalli provided no additional support 

for his contention that the thinner thickness would meet the limitation if the thicker thickness did. 

(Moalli, Tr. 388:9-389:18.) Therefore, those gloves for which Dr. Moalli could not obtain a 

sample of 3.5 to 5.0 mils do not meet this limitation of claim 1. 

(5) Initially exerting an initial pressure on the hand and thereafter still 

fitting closely about the hand, but relaxing, within about 6 minutes after 

the gloves is stretched to fit about said hand, to exert on the hand a 

reducedpressure which is less than about 50% of the initialpressure. 

(a) 100% Modulus Test 

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PUBLIC VERSION 

The main dispute between the parties focuses on whether Respondents’ gloves meet the 

relaxation limitation of claim 1. (CIB at 22; RIB at 67; SIB at 1 1 .) Tillotson argues that 

Respondents’ gloves meet the relaxation requirements of claim 1 under the 100% modulus test 

set forth in the ‘616 Patent. (CIB at 22.) Dr. Moalli analyzed Respondents’ accused gloves 

using the 100% modulus test and in accordance with the industry standard guidelines of ASTM 

D-412. (Id. at 22-23.) Dr. Moalli directed trained technicians at Exponent, Dr. Moalli’s 

employer, to perform the test on the Instron tensile test machine, which is an industry accepted 

machine. (Id. at 23; CX-786 C at Q&A 102-106 (Moalli Direct).) According to Dr Moalli, the 

test was performed as follows: 

The strip sample was placed into grips on the Instron. As with the tensile test, one 

grip is fixed at the machine’s base while the other is attached to a moveable 

crosshead. The Instron was programmed to move the crosshead upward at 20 

inches per minute, in accordance with ASTM D4 12, until the specimen reached 

the required strain level (the strain was measured using a device called an 

extensometer). The strain was then held constant, and the load required to 

maintain the sample at this strain was measured for 8 minutes. The load at 6 

minutes was compared to the initial load in order to evaluate the percentage of 

relaxation. 

(CX-786C at Q&A 102 (Moalli Direct).) For each glove type, five (5) gloves were tested and 3 

tests were performed on strip sample from each glove. (Id. at Q&A 172.) Dr. Moalli recorded 

the results of the relaxation tests in CX-70. (Id. at Q&A 171 .) Dr. Moalli then took the average 

value of the relaxations tests performed on a particular glove and determined whether that value 

met the relaxation claim limitation, ie., whether the glove relaxed to less than about 50% of the 

pressure. (Id. at Q&A 173-1 8 1 .) If the glove met this limitation of relaxing to less than about 

50% of the initial pressure, then a “Y” was placed in the column labeled “Relaxes to Less Than 

About 50% of Initial Pressure.” (Id. at Q&A 13 1 - 139, 173-1 79 and 190-202; CX-34-50, CX-8 1- 

90, and CX-803-805.) Thus, Tillotson argues that under the 100% modulus test performed by Dr. 

33 
PUBLIC VERSION 

Moalli, well over 90% of the 200 different glove types tested were found to infringe the ‘616 

Patent. (CIB at 23.) 

Respondents argue that its accused gloves do not meet the relaxation limitation for a 

variety of reasons. First, Respondents argue that Dr. Moalli’s 100% modulus test cannot 

establish that Respondents’ accused gloves infringe Claim 1 because of the high variability in 

test results, which apply only to the specific lots of gloves tested and cannot support a general 

exclusion order. (RIB at 67-70.) Respondents further argue that Dr. Moalli’s 100% modulus test 

fails to show that Respondents’ accused gloves meet the relaxation limitation because Dr. Moalli 

conducted the 100% modulus tests improperly and selectively picked data to maximize his 

results while ignoring test reports that showed that the data he had relied upon were unreliable 

and faulty. (Id. at 70.) Specifically, Respondents argue that Dr. Moalli improperly began 

recording relaxation data before the cross head in the Instron machine had stopped moving, 

rather than waiting until the sample had reached a constant deformation. (Id. at 70-71 .) As a 

result of this, Respondents argue that the data collected by Dr. Moalli is unreliable and 

inaccurate. (Id. at 71-72.) Respondents argue that the proper method of performing the 100% 

modulus test involves only taking into consideration relaxation data after the cross head had 

stopped moving and the sample had reached constant deformation. (Id. at 72-73.) 

Second, Respondents argue that the 100% modulus test fails to show that Respondents’ 

accused gloves meet the relaxation limitation of claim 1 of the ‘616 Patent because Dr. Moalli 

cannot correlate the results of the 100% modulus test with the actual relaxation in pressure on the 

hand. (Id. at 74.) Respondents argue that the claim language, e.g. “to exert on the hand the 

reduced pressure which is less than about 50% of the initial pressure,” requires a measurement of 

the actual pressure exerted on the hand by the glove based on the ordinary meaning of the words. 

34 
PUBLIC VERSION 

(Id. at 74.) Respondents further argue that this is supported by the specification, prosecution 

history, and testimony of one of the inventors, Mr. Luc DeBecker. (Id. at 74-76.) Respondents 

further argue that its construction does not conflict with the Court’s claim construction, which 

Respondents argue only construed the term “initial pressure” as not requiring a direct 

measurement of the actual pressure on the hand. (Id. at 76.) Respondents further argue that 

while any measurements may be taken, such measurements must be used to show a reduction in 

pressure on the hand. (Id. at 76-77.) Respondents argue that Dr. Moalli was unable to show how 

the data generated by the 100% modulus test correlate with an actual reduction in pressure on the 

hand by the glove and, therefore, cannot show that Respondents’ accused gloves infiinge any 

claim of the ‘616 Patent. (Id. at 77.) 

Third, even if the Court were to accept the 100% modulus test data, Respondents argue 

that none of the accused gloves infringe because an “adjustment factor” must be applied to 

account for the difference in degree of relaxation when the glove is stretched 100% instead of 

lo%, which more accurately reflects the amount of stretch when the gloves are on the hand. (Id. 

at 88.) Respondents argue that “one needs to adjust the 100%-stretch figure upwardly by 24%” 

to obtain the correct stretch relaxation figure for a glove that is donned on the hand. (Id. at 88.) 

Taking into consideration that adjustment factor, Respondents argue that all of the accused 

gloves would fail to satisfy the relaxation limitation of claim 1. (Id. at 88.) 

Staff argues that Tillotson has met its burden of demonstrating by a preponderance of the 

evidence that certain of Respondents’ gloves meet the relaxation requirement of claim 1. (SIB at 

1 1 .) Staff argues that Dr. Moalli’s use of the 100% modulus test to determine the amount of 

relaxation to prove infringement is appropriate in light of the Court’s Murkmun Order, Dr. 

Moalli’s testimony that the test is an appropriate surrogate for measuring actual pressure, and 

35 
PUBLIC VERSION 

similar testing of elastomeric materials by other third parties. (Id. at 1 1 - 12.) Staff further argues 

that Dr. Moalli’s 100% modulus test was performed in accordance with the method and protocol 

set forth in the ASTM D-412 standard. (Id. at 13.) Staff further argues that Respondents’ 

arguments requiring that the actual pressure on the hand be measured in order to meet the 

relaxation requirement is simply a re-argument of its claim construction argument for claim 1. 

(Id. at 13.) Staff argues that Respondents’ argument is contradicted by Dr. Moalli’s testimony, 

the patent specification, and the Court’s Markman order, which all acknowledge that the 100% 

modulus test can assess reduction in pressure on the hand. (Id. at 13-14.) 

Both Tillotson and Staff argue that small differences in the relaxation results does not 

mean that the 100% modulus test performed by Dr. Moalli is inconsistent or unreliable such that 

Respondents gloves cannot be found to infringe. (CRB at 37-38; SRB at2-3.) The Court agrees. 

Respondents argument that any variability in results automatically negates Dr. Moalli’s 

relaxation results and a finding of infringement fails in light of the evidence and expert 

te~timony.~ First, Dr. Moalli performed the 100% modulus test in accordance with ASTM D412 standards and found that most of Respondents’ gloves infringe Claim 1. (CX-786 C at Q&A 

102-108; 131-139, 170-179 and 190-202 (Moalli Direct); CX-34-50, CX-81-90, and CX-803- 

805.) Dr. Moalli testified that if a particular glove style was found to infringe, then all gloves of 

the same style that were manufactured under the same conditions would yield the same results: 

Q. And, sir, the differences between lot numbers that counsel questioned you 

about earlier, do you recall that testimony generally? 

A. Yes. 

Q. 

an opinion in general as to whether if you found a particular glove style to 

Would you, based on all the testing you have done in this case, do you have 

Respondents’ argument also fails in light of its own expert’s test results. Respondents’ own expert, Mr. Del 

Vecchio, tested only 88 glove styles, which Respondents argued was a “statistically valid sample of Respondents 

overall glove population.” (RIB at 79; inpa Section 1V.B. 1. a) (5) (b).) Dr. Moalli tested over 200 different styles 

of gloves. (CX-786C at Q&A 35-41 (Moalli Direct); CX-33, CX-80 and CX-802.) If Mr. Del Vecchio provided a 

“statistically valid sample”, then Dr. Moalli has as well. 

3 

36 
PUBLIC VERSION 

infringe, it would be likely that all gloves of that style would likewise infringe, 

absent contrary information? 

A. 

Q. 

A. 

believe why one would infringe and another wouldn't. 

I do have an opinion, yes. 

And what is that opinion, sir? 

I would, provide the gloves are made consistently, I would have no reason to 

(Moalli, Tr. 5 13: 1 1-5 14: 1 .) Dr. Moalli testified that some small variations in results are expected 

given certain conditions such as different manufacturing conditions, different testing conditions, 

and different glove styles. (Moalli, Tr. 444:16-21; 457:19-23; 502:8-12; 1608:lO-16.) 

In response to Respondents' argument that the 100% modulus test was improperly 

conducted, both Staff and Tillotson argue that Dr. Moalli properly performed the 100% modulus 

test according to ASTM D-412 standards and the '616 Patent. (CRB at 38-41; SRB at 3-4.) The 

Court agrees. First, Dr. Moalli explained that he properly performed the 100% modulus test in 

accordance with the procedures set forth in ASTM D-412 standards and the '616 Patent. (CX786 C at Q&A 102 (Moalli Direct).) Second, Respondents have mischaracterized the test data in 

an attempt to argue that Dr. Moalli improperly performed the 100% modulus test and produced 

unreliable data. Dr. Moalli explained the effect of the crosshead movement during the 100% 

modulus test on the Instron machine and the effect that had on the data that Respondents argue is 

evidence of unreliability: 

THE WITNESS: Okay. So as Mr. Pieja said, our instrument is very productive 

here. In this span of one second, we probably gathered 100,200 data points. So it 

is sampling very quickly. But you need to understand what happens. Otherwise it 

can be very confusing and misleading. 

So the machine, we tell the machine to pull to this 100 percent extension, right. 

And so as Mr. Pieja described, the cross-head moves up, all right? When it gets 

to 100 percent extension, it can't stop just like that. What it does is it slows down. 

So we have this, we have a load cell and attached to that load cell are some grips. 

And they are, compared to the weight of the sample, they are fairly beefy, they are 

pneumatic and they're used to clamp the sample title. 

37 
PUBLIC VERSION 

So as that cross-head comes up and slows down, it is just like putting on the 

brakes in your car. What happens to you? You go forward and you are sort of 

restrained by your seatbelt. 

So what happens here is that the grip that's holding the sample doesn't 

instantaneously stop? It moves up. Okay? And so what happens is the load cell 

thinks that everything is getting lighter. And the reason is it is being unloaded by 

this inertia of what we call the sprung mass. Okay? 

So even though this little blip which happens over, what, a tenth of a second, 

something like that, shows that there is a drop in the load here, there is actually 

not. What is really happening is this grip is trying to slow down. And when it 

does that, it takes load off of the load cell. 

So the sample still feels and, in fact, if you look at the extension at this time, I was 

just looking at that, it is actually going up, right? Or the strain in the 

extensometer. So what the sample is actually feeling is different than the load 

output. And anyone who is skilled in testing will understand that this is a 

phenomena that happens and you just -- it happens over such a small time frame, 

we don't even consider it. We disregard it. 

(Moalli, Tr. 474:8-476:6.) Dr. Moalli even testified that one of ordinary skill would understand 

this process and disregard it. Thus, the minor fluctuation in the data that Respondents argue 

evidences unreliability is not a result of changes in the elastomeric sample, but rather a result of 

the mechanics of the Instron machine. The Court finds Respondents' arguments unpersuasive. 

Dr. Moalli properly performed the 100% modulus test in accordance with ASTM D-412 

standards and the '6 16 Patent, and the data he relied upon to show the relaxation qualities of 

Respondents' accused gloves were accurate and reliable. 

Both Tillotson and Staff also disagree with Respondents contentions that the amount of 

actual pressure on the hand must be determined. Staff and Tillotson argue that the 100% 

modulus test is an appropriate surrogate for evaluating a reduction in pressure on the hand. (SIB 

12-25; CRB at 40-4 1 .) As the Court explained in the Markman Order, the amount of stress 

measured by the 100% modulus test can be used to simulate the amount of pressure on the hand. 

The Court noted that this was supported by the specification: 

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PUBLIC VERSION 

The specification of the ‘616 Patent discusses the pressure exerted by the 

elastomeric material in the context of discussing the resilience and relaxation of 

the material: 

The invention fulfills these and other objects by providing an 

elastomeric material characterized by . . . having a relatively high 

tensile strength, and having a relatively low level of resilience. 

More specifically, the elastomeric material of the present invention 

is characterized by having a tensile strength . . . and having elastic 

properties such that when the elastomeric material is stretched 

from an initial configuration to fit about an object, the elastomeric 

material conforms to the configuration of the object, initially 

exerting a predetermined pressure on the object and thereafter 

relaxing to exert on the object a reduced pressure which is 

substantially less than about 80% of the Predetermined pressure. 

(‘616 Patent 25-21) 

. . . The relatively low resilience, allows the elastomeric material 

of the present invention and gloves made therewith to relax after 

being stretched while the stretch is maintained. In other words, the 

elastomeric material of the present invention has elastic properties 

such than [sic] when the elastomeric material is stretched from an 

initial configuration to fit about an object such as a hand, the 

elastomeric material conforms to the configuration of the object, 

initially exerting a predetermined pressure on the object and 

thereafter relaxing to exert on the object a reduced pressure which 

is substantially less than about 80% or [sic] the predetermined 

pressure. (‘616 Patent 4:46-57.) 

Thus, while the patent does not explicitly state that the relaxation in stress 

and resilience directly correlates to the reduction in pressure, the patent repeatedly 

discusses the elastomeric material’s low resiliency as affecting the ability of the 

elastomeric material to relax, i.e. to reduce the pressure on an object. The 

specification further describes the manner in which the resilience is measured, 

namely the 100% modulus test: 

The resilience of the gloves made according to Example 1 and a 

conventional natural rubber latex glove was tested as follows. A 

sample was cut from each glove and stretched to 100% of its 

length to determine the initial 100% modulus according to ASTM 

D - 412 . . . As can be seen from FIGS 1 and 2, the stress required 

to maintain the 100% stretch of the Example 1 glove sample was 

substantially zero within six minutes after the initial stretch, while 

the stress required to maintain the 100% stretch of the conventional 

glove sample dropped to only about 80% of the initial stress over 

the 30 minute period. (‘6 16 Patent 6: 1 1-26.) 

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PUBLIC VERSION 

The amount of relaxation of the elastomeric material is measured 

according to the 100% modulus test. As noted above, the specification repeatedly 

discusses the elastomeric material’s relaxation properties as affecting the 

material’s ability to exert pressure. As such, the relaxation measurements from 

the 100% modulus test can be used to “simulate” the reduction in pressure on the 

hand. 

(Order No. 63 at 35-36.) The Court further noted that the prosecution history supported 

the use of the 100% modulus test to measure relaxation: 

The prosecution history also supports the use of the 100% modulus test in 

simulating the measurements of the “amount of pressure.” In rejecting Claim 1, 

the examiner stated: 

With regard to the recitation in Claim 1 of the glove “relaxing to 

exert on the hand a reduced pressure which is substantially less 

than about 80% of the initial pressure”, Applicant’s Table 5 (see 

Declaration Under 37 C.F.R. tj 1.132) shows that the 5mil sample 

of Miller’s material exerts a pressure of less than about 80% of the 

initial pressure after about 1 minute. (Tillotson App., Ex. 2 at 

TLCOOO 152) 

Applicant’s table 5 (see Declaration Under 37 C.F.R. tj 1.132) 

shows values of remaining stress after specified time periods for a 

two samples of material disclosed in the Miller ‘ 189 patent. It can 

be seen that such values approach 50% such as in Claim 13, but the 

testing was extended only to a time which showed 54% of the 

pressure remaining. Thus, if the testing continued on for a longer 

period of time, it appears that the value of 50% would have been 

reached. Morever, the value of 54%, which was reached with the 5 

mil sample, is sufficiently close to meet a limitation of “about 

50%” such as in Claim 13. 

1.. 

Alternatively, even if the 54% reduction of the 5 mil sample is not 

sufficient to meet the limitation of about 50%, and if the sample 

used in the testing for Table 5 would at no time reach 54% of 

pressure remaining, Miller ‘ 189 teaches that various modifications 

may be made in the amount used of the components of the 

material. . . . (Tillotson App., Ex. 2 at TLCOOO153-TLC000154) 

The examiner used the data obtained in the stress-relaxation test as the 

measurement of the amount of reduced pressure, e.g. “[a]pplicant’s Table 5 . . . shows that the 5 mil sample of Miller’s material exerts a pressure of less than 

about 80% of the initial pressure after about 1 minute.” (Tillotson App., Ex. 2 at 

TLC000152) Thus, the prosecution history supports the use of the 100% modulus 

40 
PUBLIC VERSION 

test to measure the “amount of pressure.” There is no evidence in the patent or 

prosecution history that shows or requires that the actual pressure on the hand had 

been measured or that it must be measured. 

(Order No. 63 at 36-37.) Dr. Moalli also testified that the 100% modulus test was a 

“fantastic surrogate” for measuring the actual pressure on the hand because “the pressure 

on the hand is caused by the stress in the glove.” (Moalli, Tr. 414:21-415:9.) Even 

Respondents’ expert, Mr. Del Vecchio, acknowledged the relationship between stress and 

pressure: 

Q. When you report pressure remaining, in fact, what you’re evaluating is force, 

true? 

A. That’s true. There is actually no such thing as a direct measurement of 

pressure. 

Q. And the thing that causes the force on the spherical indenter in your test is 

the stress in the glove sample that is being pushed down on the spherical indenter, 

true? 

A. Actually, the indenter exerts a force on the rubber, so to speak, and that’s 

what’s being measured by the force cell, but, yes, the stress in the rubber has to 

equal the force that’s being actually exerted. So whether you say it’s the rubber 

exerting force on the rubber or the indenter exerting, actually, the indenter exerts 

strain on the rubber. 

And the strain on the rubber generates a force in the rubber which is reflected 

through the inventor piston down to the load cell. 

Q. And that force in the rubber would be referred to as stress, true? 

A. Yes. 

(Del Vecchio, Tr. 1008:21-1009: 18.) Respondents continue to seek a measurement of actual 

pressure on the hand, but points to nothing in the language of the ‘6 16 Patent or the prosecution 

history that requires a measurement of actualpressure on the hand As noted above, there is 

clearly a correlation between the reduction in pressure and the stress of the elastomeric material, 

i.e., the resiliency and relaxation properties of the elastomeric material. That correlation is 

taught both in the specification and in the prosecution history and has been confirmed by those of 

skill in the art. Thus, the 100% modulus test can be used to determine the relaxation properties 

41 
PUBLIC VERSION 

and reduction in pressure of the gloves without any need to measure andor provide a direct 

correlation to the actual pressure, or reduction thereof, on the hand. 

In response to Respondents’ argument that an “adjustment factor” must be applied to the 

results of the 100% modulus test, Tillotson and Staff argue that no adjustment factor needs to be 

applied to the test results. (CRB at 44-45; SRB at 5.) The Court agrees. Respondents provide 

no basis for the “adjustment factor” nor do they point to anything in the record that would 

indicate that such an adjustment factor is “necessary” or how it would function to “more 

accurately reflect what the relaxation in pressure on the hand would be.” (See RIB at 88.) 

Thus, the Court finds that the 100% modulus test was properly conducted by Dr. Moalli 

and that the results from the test are an acceptable means of determining the relaxation properties 

of the Respondents accused gloves and whether those gloves infringe the ‘61 6 Patent. 

(b) Del Vecchio Test 

In addition to arguing that Tillotson failed to prove infringement, Respondents argue that 

they affirmatively have proven non-infringement of their gloves using a test designed by Mr. R.J. 

Del Vecchio (“the Del Vecchio Test”). (RIB at 77-78.) Respondents argue that the Del Vecchio 

Test was designed to measure the “relaxation behavior of a glove when worn on a user’s hand” 

and that it “closely mirror[s] both the degree and the type of stretching that a glove sample would 

experience in actual use.” (Id. at 78.) The Del Vecchio Test took such measurements by 

measuring the actual pressure exerted by the accused gloves and by measuring the relaxation of a 

sample of the accused gloves. (Id. at 78-79.) 

Specifically, Mr. Del Vecchio created a device that could measure the actual pressure 

exerted by the accused gloves by mounting six thin pressure sensors on the outside of a thin, 

form fitting cotton glove. (Id. at 78.) This device was then placed on the hand of one of the 

42 
PUBLIC VERSION 

engineers assisting Mr. Del Vecchio and samples of the accused gloves were donned over the 

cotton glove. (Id. at 78.) Based on the data produced by the device, Mr. Del Vecchio 

determined that the pressure exerted on the hand by any of the accused gloves was 

approximately 1.50 pounds per square inch (psi). (Id. at 79.) 

Mr. Del Vecchio then took a circular sample of material from the accused glove and 

mounted it in on a drum, which was secured on vertical mount and lowered until the sample 

came into contact with a piston with a spherical indenter mounted on it. (Id. at 79.) The sample 

was lowered until the load cell, which was located under the piston to measure the force exerted 

by the glove sample on the indenter, recorded a value equivalent to a pressure of 1.50 psi. (Id. at 

79.) At that point, the drum was locked into place and an initial pressure value was recorded. 

(Id. at 79.) The decay in force was recorded over the course of seven minutes, from which Mr. 

Del Vecchio calculated the relaxation in the samples. (Id. at 79.) 

Mr. Del Vecchio tested 88 different types of gloves produced by the K&E Respondents 

in this investigation and determined that 85 retained more than 55% of their initial stress after six 

minutes of testing. Based on this test, Respondents argue that these accused gloves failed to 

satisfl the relaxation requirement of claim 1. Respondents fiwther argue that the Del Vecchio 

Test was of crucial significance because he tested 10 styles of gloves that Dr. Moalli argued had 

the greatest degree of stress relaxation. (Id. at 79.) Respondents hrther argue that while Mr. Del 

Vecchio did not test all of the accused gloves, he had tested a large enough sampling such that it 

provided a statistically valid sampling of Respondents’ overall accused gloves. (Id. at 79-80.) 

Respondents argue that the Del Vecchio Test should be credited over the 100% modulus 

test because “Mr. Del Vecchio’s tests were conducted under conditions designed to more closely 

approximate the relaxation claimed in the ‘616 [Platent” and more closely replicates the 

43 
PUBLIC VERSION 

conditions that a glove would experience when it is actually worn on the hand. (Id. at 80.) 

Respondents further argue that the Del Vecchio Test takes into account the fundamental 

chemistry of carboxylated nitrile rubber (L‘XBNR’), which dictates that it will relax more if it is 

subject to a higher degree of strain and that Dr. Moalli has failed to address the chemistry of 

relaxation in XNBR and, instead, resorted to collateral attacks4 (Id. at 8 1-84.) 

Respondents also argue that Tillotson’s attacks on the validity and acceptability of the 

Del Vecchio Test are irrelevant and disingenuous in light of the fact that the 100% modulus test 

has not been accepted as a standard test for stress relaxation. (Id. at 86.) Similarly, Respondents 

argue that Tillotson’s attacks on the Del Vecchio Test data because of too much “pre-stress” on 

the sample are unfounded and inaccurate because the samples were not greatly stressed when 

they were loaded on the drum nor were the samples subject to stress for too long of a period 

before secured into the proper position before taking relaxation measurements. (Id. at 87.) 

Tillotson argues that the Del Vecchio Test has fundamental flaws in the manner in which 

it was conceived, executed, and presented to the Court and, as such, is entitled to no weight. 

(CIB at 24.) Tillotson argues that Mr. Del Vecchio admitted that the Del Vecchio Test is wildly 

imprecise and gives results varying by as much as 50% for gloves taken from the same box. (Id. 

at 24-25.) Tillotson further argues that the relaxation values of the Del Vecchio Test are 

artificially depressed because the engineers were untrained and inexperienced in using an 

uncalibrated prototype device and because engineers placed stress on the sample, which caused 

some relaxation, prior to beginning to record relaxation data. (Id. at 25.) Tillotson further argues 

that the Del Vecchio Test actually refutes Respondents’ non-infringement contentions because 

In mher support of the validity of the Del Vecchio Test, Respondents point to laboratory data fiom third party 

Zeon Corporation. (RIB at 84.) The laboratory data showed that tests performed on two commercially available 

nitrile gloves yielded consistent results, namely that the more a glove stretched, the more it relaxed. (FUB at 84-85.) 

Thus, Respondents argue that the relaxation of XNBR is dependent on the degree of strain. (RIB at 85.) 

4 

44 
PUBLIC VERSION 

some gloves were actually found to infringe the ‘616 Patent, but that Mr. Del Vecchio and the 

engineers continued to test those gloves until they produced non-idringing results. (Id. at 25-26.) 

Tillotson further argues that had the Del Vecchio Test been performed using an “automatic 

operation” for lowering the drum as Dr. Moalli had done in recreating the Del Vecchio Test, the 

test results would have shown relaxation values significantly lower than 50%. (Id. at 26-27.) 

Staff argues that the manner in which the Del Vecchio Test was conducted was flawed, 

resulting in inaccurate and unreliable results. (SIB at 16.) Staff further argues that the drum 

portion of the Del Vecchio Test failed to accurately measure the stress relaxation of the gloves to 

simulate the pressure on the hand due to the unintentional stretching of the elastomeric sample 

over the drum and the delay in recording the pressure. (Id. at 16-17.) Staff argues that Mr. Del 

Vecchio’s failure to record any data prior to the sample being locked into place failed to take into 

account the force that was being applied to the sample and the relaxation of the sample during 

that time. (Id. at 17.) Staff argues these flaws render the test results an inaccurate measure of the 

stress relaxation of the properties of the gloves examined. (Id. at 17.) Staff further argues that 

the Del Vecchio Test is not easily reproduced and that, even with correction of some deficiencies, 

Dr. Moalli notes that it would be nearly impossible to consistently perform the Del Vecchio Test 

compared to the 100% modulus test. (Id. at 17.) 

The Court finds that the Del Vecchio Test produced unreliable results and fails to show 

non-infringement. As an initial matter, the Court notes that neither the 100% modulus test nor 

the Del Vecchio Test are accepted ASTM standards for measuring stress relaxation. The 100% 

modulus test is a modification of the ASTM D-412 test for tensile strength. (RX-10) The Del 

Vecchio Test was designed solely in response to this litigation in order to “closely mirror both 

the degree and the type of stretching that a glove sample would experience in actual use.” (RIB 

45 
PUBLIC VERSION 

at 78.) However, the Del Vecchio Test suffers from some serious flaws compared to the 100% 

modulus test and those flaws have a significant impact on test results and on Respondents' proof 

on non-infringement. 

First, the Del Vecchio Test requires the elastomeric sample be subject to some stretching 

when the sample is being mounted to the drum. At the hearing, the Court viewed a video 

showing the placement of the elastomeric sample on the drum while the engineer explained what 

he was doing: 

THE NARRATOR: First thing we do is cut out a section of the glove to use as 

test film. We're going to mount the film across this cup, it's a -- cup, and it has a 

square groove with a square O-ring. We've affixed the edges of the film in place. 

The goal is to have the film stretched smoothly, but not tightly across the cup. So 

we get the O-ring in place, to lock the film in place, and then we kind of pull it to 

make sure we have a nice surface to test. 

(Del Vecchio, Tr. 992: 14-24.) The video shows the engineer pulling and stretching the sample 

into place, which Mr. Del Vecchio admitted, would result in some stress relaxation. (Del 

Vecchio, Tr. 997:3-19.) Dr. Moalli also testified that some degree of stress relaxation occurred 

during the mounting of the elastomeric sample. (CX-839C at Q&A 209-210 (Moalli Rebuttal).) 

Thus, even before actual testing has begun, the elastomeric sample was already subject to a 

degree of stress relaxation. 

The Del Vecchio Test is further and more significantly flawed by the significant delay in 

time between the point when force was applied to the sample by the spherical indentor and the 

point where the engineers began to collect data. Mr. Del Vecchio explained the process as 

follows: 

A. That's correct. As best I understand this process, the process involves 

lowering a frame with the rubber sheath or diaphragm fixed on it until it contacts 

the indenter and to apply pressure, and you keep doing that until you get to the 

pressure neighborhood, preferably 1.5, that you wish to be in. 

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PUBLIC VERSION 

(Del Vecchio, Tr. 971 :25-972:6; RX-114B.) Thus, once the sheath came into contact with the 

indentor, force was applied to the sample and continued to be applied while the engineer 

manually adjusted the machine until it reached approximately 1.5 psi, the pressure that was 

determined in the first part of the Del Vecchio Test when it was placed on the sensor-mounted 

cotton glove. (Del Vecchio, Tr. 970:22-24.) During this adjustment time, the force applied to 

the sample was essentially ignored by the engineers and Mr. Del Vecchio even though there was 

admittedly a degree of stress relaxation. (Del Vecchio, Tr. 970:24-97 1 : 16.) This initial, 

unrecorded relaxation resulted in depressed, unreliable test results. (CX-896C at Q&A 195 

(Moalli Rebuttal) .) 

In addition to failing to take into account the stress relaxation that occurred to the sample 

during mounting and the adjustment period, the Del Vecchio Test is also subject to significant 

human error. Mr. Del Vecchio himself admitted that the test was subject to a significant amount 

of data scatter due to “the fact that a human operator is lowering this is a major source of scatter 

in itself.” (Del Vecchio, Tr. 1025:22-24.) Moreover, when questioned by the Court about the 

varying test results, Mr. Del Vecchio admitted that several adjustments to the Del Vecchio Test 

were necessary: 

I would center the ball better, I would probably find other ways to make the 

specimen mounted more evenly. So the test is clearly subject to more scatter than 

I wish it were ... 

(Del Vecchio, Tr. 1026: 17-22.) Thus, the Del Vecchio Test, as it was conducted for this 

consolidated investigation, is flawed enough such that the Court finds that the data produced is 

unreliable. 

Respondents argue that any such stress relaxation is de minimus and no more significant 

than those of the 100% modulus test. (Del Vecchio, Tr. 997:3-19.) In particular, Respondents 

47 
PUBLIC VERSION 

argue that the adjustment period for most of the samples tested by Mr. Del Vecchio was only 6-9 

seconds before the sample was locked into place and readings of the sample were collected. 

(RIB at 86-87.) Respondents argue that this time frame is almost identical to the amount time 

the samples were stressed in the 100% modulus test. (Id at 87.) A cursory review of RX-328, 

however, shows that the adjustment varied from 4 seconds to as much as 25 seconds. (RX-328 

at RJD0002708-9 and RJD0003616-7.) Moreover, as Mr. Del Vecchio acknowledged, since the 

engineer was manually trying to adjust the sample, the adjustment period was longer and more 

varied due to human error compared with the 100% modulus test where the stretching of the 

sample was automated on the Instron machine. (Del Vecchio, Tr. 969:3-12.) 

Thus, given the unreliability of the data generated by the Del Vecchio Test, the Court 

finds that Respondents have failed to show non-infringement of the accused gloves. 

(e) Conclusion 

Based on the reasons set forth above, the Court finds that the evidence shows that the 

100% modulus test can be used to determine whether the accused gloves meet the relaxation 

limitation of claim 1. The Court further finds that Dr. Moalli properly conducted the 100% 

modulus test and that those test results are acceptable to show whether the Respondents’ accused 

gloves meet the relaxation limitation. The Court finds that the evidence shows that Respondents 

gloves listed in CX-34-50, CX-8 1-90, and CX-803-805 with a “Y” under the column labeled 

“Relaxes to Less than 50% of Initial Pressure” relax to “initially exerting an initial pressure on 

the hand and thereafter still fitting closely about the hand, but relaxing, within about 6 minutes 

after the gloves is stretched to fit about said hand, to exert on the hand a reduced pressure which 

is less than about 50% of the initial pressure.” (CX-34-50; CX-81-90 and CX-803-805.) 

Therefore, the Court finds that those gloves meet the relaxation claim limitation. 

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PUBLIC VERSION 

b) The Doctrine of Equivalents 

Tillotson did not offer any evidence that Respondents’ nitrile gloves infringe the ‘61 6 

Patent under the doctrine of equivalents. Pursuant to Ground Rules 8(f) and 1 1.1 ,5 Tillotson has 

waived the opportunity to raise this issue. 

e) Conclusion 

As set forth supra, the evidence shows that certain of Respondents’ gloves listed in CX34-50, CX-81-90 and CX-803-805 meet some or all of the claim limitations of claim 1 of the 

‘616 Patent. (CX-34-50; CX-81-90 and CX-803-805.) Those gloves that meet every limitation 

of claim 1 have been consolidated into a single list attached hereto as Appendix C. Therefore, 

the Court finds those of Respondents gloves listed in Appendix C literally infringe Claim 1 of the 

‘616 Patent6 

2. Claims 17,18 and 19 

Claims 17, 18 and 19 depend on independent claim 1 of the ‘6 16 Patent. Inasmuch as 

each claim limitation must be present in an accused device in order for infringement to be found 

(either literally or under the doctrine of equivalents), a device cannot infringe a dependent claim 

’ Ground Rule 8(f) states (emphasis added): 

A statement of the issues to be considered at the hearing that sets forth with particularity a party’s contentions on 

each of the proposed issues, including citations to legal authorities in support thereof. Any contentions not set 

forth in detail as required herein shall be deemed abandoned, or withdrawn, except for contentions of which 

a party is not aware and could not be aware in the exercise of reasonable diligence at the time of filing the 

pre-hearing statements. . . . 

Ground Rule 1 1.1 states (emphasis added): 

The post-trial brief shall discuss the issues and evidence tried within the fi-amework of the general issues determined 

by the Commission’s Notice of Investigation, the general outline of the briefs as set forth in Appendix B, and those 

issues that are included in the pre-trial brief and any permitted amendments thereto. All other issues shall be 

deemed waived. . . . 

Those accused gloves that fail to meet each and every limitation of claim I have been consolidated into a single 

list attached hereto as Appendix D. 

49 
PUBLIC VERSION 

if it does not practice every limitation of the independent claim from which it depends. See 

Warner-Jenkinson Co., 520 U.S. at 40; Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 

1359 (Fed. Cir. 2007). Furthermore, the Federal Circuit explained that: 

One may infringe an independent claim and not infringe a claim dependent on 

that claim. The reverse is not true. One who does not infringe an independent 

claim cannot infringe a claim dependent on (and thus containing all the limitations 

of) that claim. 

Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed.&. 1989). 

As noted above, those accused gloves listed in Appendix C have been found to literally 

infringe independent Claim 1 of the ‘616 Patent. (Supra B. 1 .a.) Therefore, the Court must now 

determine whether those gloves that infringe independent claim 1 infringe dependent claims 17, 

18 and/or 19 as well. 

a) Literal Infringement 

(1) Claim 1 I: A glove as in Claim 1, wherein the layer of 

elastomeric material has a thickness up to about 4.5 mils; 

And 

Claim 18. A glove as in claim 1 wherein the layer of 

elastomeric material has a thickness from about 4 to about 

4.5 mils. 

As set forth in B.1 .ah above, Dr. Moalli measured the thickness of a sample of 

elastomeric material using a Mitutoyo Model flat anvil-type thickness gauge. Dr. Moalli 

described how he measured the thickness of the gloves: 

The gauge has a 10-mm (0.394-in) diameter anvil attached to a spring-loaded 

spindle to provide a consistent applied force to the sample; this insured that the 

same pressure was applied to each sample during measurement and minimized 

any error associated with compressing the rubber samples. Three thickness 

measurements were taken from each specimen and the mean value was computed 

(median values of thickness were used for the calculation of stress in accordance 

with ASTM D412). For each glove type, I tested 5 individual gloves. From each 

glove, I excised 3 relaxation samples (15 total) and 1 tensile sample (5 total). 

50 
PUBLIC VERSION 

Because I measured the thickness of each of these samples in 3 locations, I 

actually measured the thickness of each glove type 60 times. 

(CX-786C at Q&A 70 (Moalli Direct).) Dr. Moalli then reported the results of his analysis as to 

whether the gloves met the claim limitation of Claim 17, i. e. whether the gloves had a thickness 

of up to about 4.5 mils. (Id. at Q&A 212-219.) Those results are contained in CX-52-CX-67; 

CX-92-101; CX-806-808. (Id. at Q&A 212-219; 228-235.) If the glove met this limitation of 

having a thickness of at least 4.5 mils, then a “Y” is placed in the column labeled “Up to About 

4.5 mils.” (Id.; CX-52-67; CX-92- 101; CX-806-808.) 

Similarly, if the gloves met the claim limitation of Claim 18, then a “Y” is placed in the 

column labeled “From About 4 to About 4.5 mils.” (CX-786C at Q&A 220-223; 228-235 

(Moalli Direct); CX-52-67; CX-92-101; CX-806-808.) 

The parties do not dispute that to the extent certain of Respondents’ gloves meet claim 1 

of the ‘6 16 Patent, then those gloves meet the limitations of Claims 17 and 18 of the ‘6 16 Patent. 

(CIB at 20; RIB at 67-88; SIB at 18) Respondents do not dispute that certain of its gloves have 

a thickness up to 4.5 mils. (ROCPFF-V.B.181 1-1975.)7 Respondents also do not dispute that 

certain of its gloves have a thickness of about 4.0 to about 4.5 mils. (ROCPFF- 1982-2134.)’ 

Staff also does not dispute that Respondents gloves meet this limitation. (SIB at 18.) 

The Court finds that the evidence shows that Respondents’ gloves listed in CX-52-67, 

CX-92-101, CX-806-808 with a “Y” in the column labeled “From About 4 to About 4.5 Mils” 

have a thickness of about 4.0 to 4.5 mils and, therefore, meet the claim limitation of Claim 17. 

(CX-52-67, CX-92-101, CX-806-808.) The Court finds that the evidence shows that 

In ROCPFF V.B. 1913-1921, PIP argues that the description do not identify a class of gloves imported and/or 

In ROCPFF V.B. 2077-2085, PIP argues that the description do not identify a class of gloves imported and/or 

distributed by it. However, does not dispute that it meets this limitation. a 

distributed by it. However, does not dispute that it meets this limitation. 

51 
PUBLIC VERSION 

Respondents’ gloves listed in CX-52-67, CX-92-101, CX-806-808 with a “Y” in the column 

labeled “Up to About 4.5 Mils” have a thickness up to about 4.5 mils and, therefore, meet the 

claim limitation of claim 18. (CX-52-67, CX-92-101, CX-806-808.) 

(2) Claim 19. A glove as in claim 1, therein the layer of elastomeric 

material is further characterized by having an elongation of greater 

than about 800 lbs/in. 

In order to determine the puncture resistance of the gloves, Dr. Moalli tested the accused 

gloves using a puncture test that comprised of testing round samples of the gloves with a needle. 

Dr. Moalli described his test as follows: 

In the puncture test, round samples were cut from the palms and backs of gloves, 

and then positioned between two plates mounted to a mechanical testing machine. 

A needle was attached to the crosshead of the testing machine, and as the 

crosshead was lowered at 20 inches per minute, the needle was pushed against the 

round specimen until was punctured. In the first picture [COX-1 551, we can see 

the testing machine, the sample sandwiched between the two circular plates, and 

the needle, attached to the crosshead, that is used to puncture the sample. The 

second picture [CDX-1541 is a close-up view of the needle about to contact the 

sample sandwiched between the metal plates. 

(CX-786 C at Q&A 1 15 (Moalli Direct).) Dr. Moalli reported his findings in CX-52-67 and CX92-101. (Id. at Q&A 210-214; 224-232.) If the gloves met the limitation of have a puncture 

resistance of greater than about 800 lbs/in, then a “Y” was placed in the column labeled 

“Puncture Resistance Greater Than About 800 lbs/in.” (Id. ; CX-52-67; CX-92-101.) 

The parties do not dispute that to the extent certain of Respondents’ gloves meet claim 1 

of the ‘616 Patent, then those gloves meet the limitations of Claim 19 of the ‘616 Patent. (CIB at 

20; RIB at 67-88; SIB at 18.) Respondents do not dispute that certain of its gloves have a 

52 
PUBLIC VERSION 

puncture resistance of greater than about 800 lbs/in. (ROCPFF-V.B 1648-1 8 1 0.)9 Staff also does 

not dispute that the respondents gloves meet this limitation. (SIB at 18.) 

The Court finds that the evidence shows that respondents gloves listed in CX-52-67 and 

CX-92- 10 1 with “Y” in the column labeled “Puncture Resistance Greater Than About 800 

lbs/in” have a puncture resistance of about 800 lbs/in and, therefore, meet the claim limitation of 

claim 19. (CX-5 1-67; CX-92- 10 1 .> 

b) The Doctrine of Equivalents 

Tillotson did not offer any evidence that respondents’ nitrile gloves idringe the ‘6 16 

Patent under the doctrine of equivalents. Pursuant to Ground Rules 8(f) and 1 1.1, Tillotson has 

waived the opportunity to raise this issue. 

e) Conclusion 

As set forth supra, the evidence shows that certain of Respondents’ gloves listed in CX52-67, CX-92-101, CX-806-808 meet the claim limitations of Claims 17, 18 and/or 19 of the 

‘616 Patent. (CX-52-67, CX-92-101, CX-806-808.) Those gloves that meet the claim 

limitations of claim 17, 18 and/or 19 have been consolidated into a single list attached hereto as 

Appendix C. Therefore, the Court finds those of Respondents gloves that literally infringe 

claims 17, 18 and/or 19 of the ‘6 16 Patent are listed in Appendix C and identified as infringing 

therein. 

V. VALIDITY 

A. Background 

In ROCPFF V.B. 1749-1756, PIP argues that the description do not identify a class of gloves imported and/or 99 

distributed by it. However, does not dispute that it meets this limitation. 

53 
PUBLIC VERSION 

One cannot be held liable for practicing an invalid patent claim. See Pandrol USA, LP v. 

AirBoss Railway Prods., Inc., 320 F.3d 1354, 1365 (Fed. Cir. 2003). However, the claims of a 

patent are presumed to be valid. 35 U.S.C. 9 282; DMIInc. v. Deere & Co., 802 F.2d 421 (Fed. 

Cir. 1986). Although a complainant has the burden of proving a violation of section 337, it can 

rely on this presumption of validity. A respondent that has raised patent invalidity as an 

affirmative defense must overcome the presumption by "clear and convincing" evidence of 

invalidity. Checkpoint Systems, Inc. v. United States Int 'I Trade Comm 'n, 54 F.3d 756,761 (Fed. 

Cir. 1995). 

B. 35 U.S.C. §251(Broadening Reissue) 

35 U.S.C. 9 251 7 4 states: 

No reissued patent shall be granted enlarging the scope of the claims of the 

original patent unless applied for within two years Erom the grant of the original 

patent. 

35 U.S.C. 3 251. In determining whether claims "enlarge the scope," the test is whether any 

reissue claim "contains within its scope any conceivable apparatus or process which would not 

have infringed the original patent." In re Ruth, 278 F.2d 729,730 (CCPA 1960); see also 

Tillotson Ltd. v. Walbro Corp., 831 F.2d 1033, 1037 note 2 (Fed. Cir. 1987) ("Tillotson'y. A 

reissue claim that is broader in any respect is considered to be broader than the original claims 

even though it may be narrower in other respects. Id. (internal citations omitted) A new claim 

enlarges if it includes within its scope any subject matter that would not have infringed the 

original patent. Thermalloy, Inc. v. Aavid Eng'g, 121 F.3d 691,692 (Fed. Cir. 1997) Whether 

amendments enlarge the scope of a claim is a matter of claim construction. Id.; see also In re 

Freeman, 30 F.3d 1459, 1464(Fed Cir. 1994). 

54 
PUBLIC VERSION 

Respondents argue that the ‘61 6 Patent is invalid because Tillotson improperly broadened 

the scope of the ‘362 Patent through a reissue application filed more than two years after the 

‘362 Patent issued. (RIB at 9.) Specifically, Respondents argue that Tillotson improperly 

broadened the scope of the claims by amending the claims of the ‘362 Patent from claiming a 

glove that initially exerted a “predetermined” pressure to a glove that exerted an “initial” 

pressure in the ‘616 Patent. (Id. at 10.) Respondents argue that in light of the Court’s claim 

construction and Federal Circuit precedent, the amendment invalidates the ‘61 6 Patent. (Id. at 

10.) 

Respondents argue that Tillotson has based the entirety of its argument as to why the 

amendment was not broadening on its claim construction position that “predetermined pressure” 

and “initial pressure” mean the same thing. (Id. at 1 1 .) Respondents argue that Tillotson’s 

amended claim of “initial pressure’’ fails to include the “predetermined”) limitation in the original 

claim. (Id. at 1 1 .) Respondents mher argue that the Court rejected Tillotson’s argument noting 

that since the concept of initial pressure was already in the original claim, then Tillotson’s 

argument would render the term “predetermined” superfluous. (Id. at 1 1 - 12.) 

Respondents argue that the Court’s claim construction has given clear and independent 

meaning to the “predetermined” limitation and that Tillotson omitted that limitation during the 

reissue and that by omitting that limitation Tillotson relieved itself of the need to prove that the 

pressure that is actually initially exerted on the hand upon the donning of gloves is an amount of 

pressure that has been decided in advance. (Id. at 12.) 

Respondents further argue that another test shows that Tillotson improperly broadened 

the scope of the ‘616 Patent, namely that claim 1 of the ‘616 Patent encompasses gloves that 

would not have been found to infringe the ‘362 Patent. (Id. at 12.) Respondents argue that the 

55 
PUBLIC VERSION 

use of the 100% modulus test produces results that are in no way influenced by either the size or 

shape of the hand or by the geometry of the glove. (Id. at 13.) Respondents argue that under the 

100% modulus test, which Tillotson and the Court have linked to determining the “initial 

pressure,” an Ansell glove was found to infringe claim 1 of the ‘6 16 Patent. (Id. at 13- 14.) 

Respondents argue, however, that there is no such link between “predetermined pressure” and 

the 100% modulus test and that Tillotson has, instead, argued that “predetermined pressure is a 

function of the size and shape of the hand and the geometry of the glove.” (Id. at 14.) 

Respondents then create a correction factor based on Tillotson’s sworn interrogatory answer 

where Tillotson calculated the percentages of initial stress retained after 6 minutes with respect 

to a sample stretched loo%, e.g. “initial pressure,” and a sample stretched 0.10 inches, which 

more closely simulates the performance of the glove when properly donned on one’s hand, e.g. 

“predetermined pressure.” (Id at 14.) Respondents argue that by adding the correction factor, 

the Ansell glove goes from infringing to non-infringing. (Id at 14-15.) As such, Respondents 

argue that Tillotson has improperly broadened the scope of the claims under either the limitation 

omission test or the infringing to non-infringing test and that, therefore, the asserted claims are 

invalid. (Id. at 15.) 

Tillotson argues that Respondents have failed to meet their burden of showing by clear 

and convincing evidence that Tillotson improperly broadened its claims. (CIB at 67-68.) 

Tillotson argues that there is no evidence that the initial pressure limitation encompasses any 

glove that would not have also infringed the predetermined pressure limitation. (Id. at 68.) 

Specifically, Tillotson argues that since the initial stress is determined in advance as dictated by 

physics and mechanical properties, then there is no glove that would meet the “initial pressure 

limitation” that would not also meet the “predetermined pressure” limitation. (Id at 69-70.) 

56 
PUBLIC VERSION 

Thus, Tillotson argues that while the terms “initial pressure” and “predetermined pressure” have 

different meaning, physics dictates that they encompass the same limitations. (Id. at 70.) 

Tillotson further argues that the Court’s construction of “predetermined pressure” does 

not require that an individual knowingly select a specific pressure in designing a glove. (Id. at 

70.) Tillotson argues that there is nothing in the ordinary and customary meaning of 

“predetermined” that imposes such a requirement and nothing in the file wrapper or prosecution 

history that teaches such a requirement. (Id. at 70-72.) Tillotson argues that the specification 

does not show any “foreknowledge” or “knowing selection in advance” of particular pressure. 

(Id. at 72.) Tillotson further argues that a glove designer would not be able to design a glove 

such that the 100% modulus test would result in a glove with a specific initial stress result and 

that such an impossibility is supported by the data submitted to the PTO where the initial stress 

for each of the gloves was different. (Id. at 72-73.) 

Tillotson further argues that the Court’s claim construction establishes that the 

amendment was not broadening. (Id. at 73.) Tillotson argues that since “predetermined 

pressure” is used only in the context of measuring relaxation and the Court determined that the 

100% modulus test measures relaxation, then “predetermined pressure” is clearly tied to the 

100% modulus test. (Id. at 73-74.) Tillotson fbrther argues that the Court’s understanding that 

the teaching of the patent is the reduction in pressure between the first pressure and the second 

pressure and that the reduction can be measured by the 100% modulus test, regardless of whether 

the first pressure is the “initial pressure” or “predetermined pressure,” supports its position that 

knowingly selecting the pressure in advance is not required. (Id. at 74.) 

Staff argues that the ‘61 6 Patent is invalid under 35 U.S.C. tj 25 1 74 because Tillotson 

improperly broadened the scope of the claims by replacing “predetermined pressure” in the ‘362 

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Patent with “initial pressure” in the ‘616 Patent. (SIB at 36-38.) Staff argues that Tillotson 

relies on the same logic it used to argue that “predetermined pressure” and “initial pressure” have 

the same meaning to argue that they have the same scope. (Id. at 39.) Staff argues that, based on 

the Court’s claim construction, Tillotson’s argument fails and “initial pressure” is broader than 

“predetermined pressure.” (Id. at 39.) Staff argues that the critical difference between the 

Court’s construction of the two terms is that “predetermined pressure” requires that the amount 

of pressure be decided in advance and that absent this critical difference, both terms would 

merely measure the amount of pressure exerted on the hand after the glove is donned. (Id. at 39- 

40.) 

Staff argues that the intrinsic record refutes Tillotson’s position that the scope of “initial 

pressure” and “predetermined pressure” are the same. (Id. at 40.) Staff argues that the plain 

language of “predetermined” requires that one decide in advance the amount of pressure that will 

be exerted. (Id. at 40.) Staff argues that Tillotson attempts to read this limitation out of the 

claim by arguing that the “predetermined pressure” can be any pressure. (Id. at 40.) Staff further 

argues that the specification discloses the predetermination as evidenced by Figure 2 of the ‘616 

Patent. (Id. at 40.) Staff argues that Figure 2 shows that the inventors actually determined the 

stress of the gloves in actual psi over time rather then just a percentage comparison of relaxation 

over time. (Id. at 40.) Staff argues that this evidences not a specific predetermined pressure, but 

rather evidences that the amount of pressure on the hand when the glove is donned must be 

decided in advance. (Id at 40.) Staff argues that this is distinct from “initial pressure,” which 

only requires that there be an amount of pressure when the glove is donned. (Id. at 41 .) 

Staff further argues that it is clear that claim 1 of the ‘616 Patent is broader than the ‘362 

Patent because it contains within its scope a glove that would not have infringed Claim 1 of the 

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‘362 Patent. (Id. at 41 .) Staff argues that a glove could have an arbitrary “initial pressure” on a 

hand where it was not decided or known in advance what the pressure was when the glove was 

donned, i. e., there was no “predetermined pressure.” As such, the glove would fall outside the 

scope of claim 1 and not infringe the ‘362 Patent. (Id. at 41 .) 

First, the parties do not dispute that the reissue application for the ‘616 Patent (November 

13, 1995) was filed more than two years after the issuance of the ‘362 Patent (May 14, 1991). 

(RIB at 10; CIB 67-74; SIB at 39, note 31.) The Court finds that the reissue application for the 

‘616 Patent was filed more than two years after the issuance of the original ‘362 Patent. (JX-3, 

cover page (‘6 16 Patent).) The question remaining is whether the amended claims of the ‘6 16 

Patent are broader than those of the original ‘362 Patent. For the reasons set forth below, the 

Court finds that Tillotson has improperly broadened the scope of the original claims of the ‘362 

Patent more than two years after its issuance.” 

During the reissue, Tillotson replaced the term “predetermined pressure” in claim 1 with 

‘‘initial pressure.” Specifically, the term was replaced in the relaxation limitation of the claim: 

initially exerting [a predetermined] an initial pressure on the hand and thereafter 

stillfitting closely about the hand, but relaxing, within about 6 minutes after the 

glove is stretched tofit about said hand, to exert on the hand a reduced pressure 

which is [substantially] less than about [SO%] 50% of the [predetermined] initial 

pressure. 

(JX-3 at 6:44-50 (‘616 Patent)) (emphasis in original, where “Matter enclosed in heavy brackets 

[ ] appears in the original patent but forms no part of this reissue specification; matter printed in 

italics indicates the additions made by reissue” Id. at 1 :4-8.). During the reissue proceedings, 

Mr. Tillotson submitted a Supplemental Reissue Declaration and Power of Attorney, in which he 

explained that “[almended Claim 1 differs from claim 1 of the original patent in that amended 

lo Claims 17, 18, and 19 of the ‘6 16 Patent depend from and contain all the limitations of claim 1 of the ‘6 I6 Patent. 

‘616 Patent at col. 8:9-15. 

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claim 1 describes a glove . . . capable of being stretched to fit closely about the hand and when 

stretched from an initial configuration to fit closely about the hand, exerts an initial, rather than 

predetermined, pressure on the hand.” (JX-4 at TLCOOO 178 (‘616 Prosecution History) 

(emphasis added)). Mr. Tillotson further explained that “[tlhe term ‘predetermined’ has been 

replaced with the term ‘initial’ in amended claim 1 to more clearly define the glove of claim 1 in 

accordance with p. 11 line 22 of the applicant’s description,” which forms part of a sentence 

reciting, inter alia, “the initial 100% modulus.” Id. l1 Mr. Tillotson also explained that “[tlhe 

term initial pressure more definitely describes the elastomeric properties of the glove.” (Id. at 

TLC000 182.) 

The Court construed the claim terms in dispute in the Markman Order. (See Order No. 

63 .) Specifically, the terms “a predetermined pressure on the hand” and “the predetermined 

pressure” were construed to mean “the amount of pressure decided in advance that will be 

exerted on the hand by the glove after the glove is donned.” (Id. at 14.) In rejecting Tillotson’s 

argument that “initial pressure” and “predetermined pressure” were synonymous, the Court 

explained: 

There is no evidence in the patent itself or the prosecution history that the 

patentees were their own lexicographers or that any special meaning for the term 

“predetermined” can be ascertained from the intrinsic evidence, i. e., nothing in 

the ‘362 Patent or in the prosecution history indicates that the patentees defined 

“predetermined” to mean “initial.”. . . In the reissue declaration, the patentee stated 

“[tlhe term ‘predetermined’ has been replaced with the term ‘initial’ to more 

clearly define the glove of claim 1 in accordance with p. 11 line 22 of the 

applicant’s description.” (Tillotson Br., App., Ex. 2 at TLC000035.) Such a basis 

indicates that, at a minimum, the terms “predetermined” and “initial” have a 

different meaning. Similarly, the specification does not support Tillotson’s 

construction because the specification uses the term “initially” only in the context 

of describing at what point the predetermined pressure is exerted on an object, i. e. 

“initially exerting a predetermined pressure on the object.” (‘616 Patent 3:33-34.) 

I’ The complete sentence on lines 21-23 of page 11 of the applicant’s description corresponds to that description in 

the specification of the ‘616 Patent: “A sample was cut fi-om each glove and stretched 100% of its length to 

determine the initial 100% modulus according to ASTM D-412.” (JX-3 at 6:13-15 (‘616 Patent).) 

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Predetermined Pressure 

the amount of pressure decided in advance that 

will be exerted on the hand by the glove after 

the glove is donned 

The fact that the terms are coupled together does not, as Tillotson asserts, support 

its contention that the terms should be construed to have the same meaning. 

Rather, the fact that “predetermined” and “initial” are coupled together in claim 1 

of the ‘362 Patent would indicate that the terms have separate meanings and are 

not interchangeable. Indeed, if such were the case then “predetermined” would be 

superfluous and such a construction is impermissible. 

Initial Pressure 

the amount of pressureJirst exerted on the 

hand by the glove after the glove is donned 

(Id. at 14-15.). The Court went on to find that the claim terms “an initial pressure on the hand” 

and “the initial pressure” were construed to mean “the amount of pressure first exerted on the 

hand by the glove after the glove is donned.” (Id. at 33.) The Court further found that this 

pressure can be determined by the 100% modulus test and need not be a measurement of the 

actual pressure on the hand. (Id. at 38.) 

A simple comparison of the Court’s construction of “predetermined pressure” and “initial 

(Id. at 14,33) (emphasis added). At a minimum, it is clear that the “predetermined pressure” 

requires that the amount of pressure be “decided in advance” as opposed to simply the amount of 

pressure that was “first exerted.” The amount of pressure for the “initial pressure” can be any 

pressure that is first exerted, while the amount of pressure for “predetermined pressure” requires 

that the amount be “decided in advance.” This requires a “cognitive function”, i. e. , that the 

pressure be decided or determined in advance. l2 Failure to make that decision or determination 

effectively reads that limitation out of the claim as noted by Staff and Respondents. See Pannu v. 

’* Tillotson argues that the dictionary definition of “predetermined” does not require “conscious intent on the part of 

an individual to select a particular pressure.” (CIB at 71-72.) Tillotson misunderstands the Court’s claim 

construction. The Court’s claim construction does not require a specific selection or determination of a specific 

pressure in advance, rather the Court’s claim construction requires a determination in advance of what amount of 

pressure will be exerted on the hand by the glove after the glove is donned. 

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Storz Instruments, Inc., 258 F.3d 1366, 1371 (a reissue claim that does not include a limitation 

present in the original claims is broader than the original claim). In other words, Tillotson 

improperly broadened the original claim by eliminating this limitation, i. e., deciding the amount 

of pressure in advance, to instead accepting any arbitrary amount of pressure first exerted. 

The specification and prosecution history show that the patentees themselves made such a 

predetermination. Figure 2 compares the stress required to maintain the stretch of the glove and 

is presented as stress in psi versus time. (JX-3 at 3:3-6; 6:ll-26 (‘616 Patent).). Figure 2 

demonstrates that the patentees determined the stress of the gloves in actual psi over a measure 

of time. Similarly, Table 5 of the prosecution history of the ‘616 Patent shows that Mr. Tillotson 

and Mr. DeBecker determined the stress of the listed gloves in actual psi over a measure of time. 

(JX-4 at TLC000049 (‘616 Prosecution History).) What this demonstrates is not a specific 

amount of pressure or that the patentees had any “foreknowledge” of what the actual amount 

pressure would be, rather it evidences that the amount of pressure on the hand when the glove is 

donned was decided in advance. This stands in stark contrast to the limitation in reissued claim 

1 that merely requires an “initial pressure,” which does not require any advanced determination 

of that pressure when the glove is donned and only requires that there be an undetermined 

amount of pressure when the glove is donned. (JX-3 at 6:33-50 (‘616 Patent, Claim l).). Thus, 

the absence of the limitation requiring that the amount of pressure be decided in advance in the 

construction of “initial pressure” results in a broadening of claim 1. , 

Moreover, claim 1 of the ‘6 16 Patent is broader because it contains within its scope a 

glove that would not have infringed original claim 1 of the ‘362 Patent. For example, one could 

have a glove with an arbitrary amount of ‘‘initial pressure,” without any advance determination 

of the amount pressure exerted by that glove will be when it is donned, but which met every 

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other limitation of claim 1 and all other elements of the relaxation limitation of claim 1 of the 

‘616 Patent, e.g. was shown to relax to less than about 50% of the of the “initial pressure.” 

However, since there is no determination or decision in advance as to the amount of pressure that 

will be exerted on the hand by the glove after the glove is donned, then the “predetermined 

pressure” claim limitation of the original ‘362 Patent is not met. In other words, as aptly stated 

by Staff “a glove that exerts an undetermined amount of initial pressure and that otherwise 

satisfies all of the limitations of reissued Claim 1 would infiinge the reissued claim, but would 

not infringe original claim 1 of the ‘362 patent, which requires that the glove exert a 

predetermined pressure, i. e., an amount of pressure determined in advance.” (SIB at 4 1 .) 

Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed. Cir. 1999) (“A claim 

of a reissue patent application is broader in scope than the original claims if it contains within its 

scope any conceivable apparatus or process which would not have infringed the original patent.”). 

Respondents have added an additional step to the Court’s construction, namely requiring 

that a specific amount of pressure that will be exerted on the glove will be decided in advance, 

e.g. “predetermining [ ] a starting pressure.” (RRB at 2; RIB at 12.) The Court’s construction 

does not require this - it only requires that the amount of pressure that will be exerted on the 

hand after the glove is donned be decided in advance, not that a specific amount of pressure that 

was decided in advance, or a “preset” specific amount of pressure, be exerted by the glove. 

(Order No. 63, at 10-14.) In other words, to satisfy claim 1 of the ‘362 Patent under the Court’s 

claim construction, one only needs to determine the amount of pressure to be exerted by the 

glove, whatever that number may be, but that number need not be decided in advance.I3 There 

l3 The plain and ordinary meaning of “decide” as defined by the American Heritage Dictionary is “1 a. To settle 

conclusively all contention or uncertainty about. b. To make up one’s mind about.” See American Heritage 

Dictionary of the English Language, Fourth Edition (2000). Here, one must “settle conclusively all contention or 

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is no requirement that “predetermined pressure” be a specific starting pressure or that the 

designer of the glove “knowingly select a specific pressure.” (See RIB at 12; CIB at 70-73.) 

Moreover, there is nothing in the specification or prosecution history that requires the 

amount of pressure be a specific amount or that the designer of the glove have any 

“foreknowledge” of a specific amount. The tern “predetermined pressure” is used multiple 

times throughout the specification in describing the relaxation qualities of the elastomeric 

material and glove, but there is no reference to a specific amount of pressure or selecting a 

specific pressure. (See generally JX-3 specification (‘61 6 Patent).) Rather, the original claim 

language requires a “predetermined pressure,” which requires, quite simply, that the amount of 

pressure must be decided or determined in advance. There is no requirement that a specific 

amount of pressure be determined in advance. 

There also is no requirement that the “predetermined pressure” be a measurement of 

actual pressure on the hand as asserted by Respondents. (RIB at 14-1 5.) As the Court explained 

supra Section IV.B.l. a)(5) and in the Markman Order, there need not be any measurement of 

actual pressure on the hand. Rather, the amount of stress measured by the 100% modulus test 

can simulate the pressure on the hand. (See Order No. 63 at 34-38.) 

Tillotson argues that while the claim constructions of “predetermined pressure’’ and 

“initial pressure’’ are different, the scope and limitations of the claims encompass the same glove. 

(CIB at 68-69.) The reason for this, Tillotson argues, is because the stress of a glove is “dictated 

by the physics and mechanical properties of the sample.” (Id. at 69-70.) The Court does not 

dispute the fact that basic physics will dictate that the stress of the glove or its physical properties. 

However, the repeated use of “predetermined pressure” in the specification and its use in the 

uncertainty about” in advance the actual amount of pressure that will be exerted on the hand when the glove is 

donned. It is not required that a specific amount of pressure that will be exerted on the hand be decided in advance. 

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original claim indicate that more was intended than just a simple acknowledgement of basic 

physics. Tillotson’ s argument would effectively read the term “predetermined” out of the claim 

and make its repeated usage in the specification of the patent completely meaningle~s,’~ as every 

glove in the world will provide some pressure on the hand as dictated by the laws of physics and 

mechanical properties. Rather, it is the “cognitive function”, the determination of what “basic 

physics had decided in advance,” e.g., the physical property of stress of the gloves, that is 

required. It is deciding or determining in advance the amount of pressure that will be exerted by 

the glove when the glove is donned, i. e., knowing in advance the amount of pressure. In contrast, 

“initial pressure” means only that some initial pressure be exerted without knowing in advance 

what it is. If this predetermination is not performed, claim 1 of the ‘362 Patent would not be 

satisfied, whereas failure to determine in advance the amount of pressure that will be exerted on 

the hand has no bearing on whether claim 1 of the ‘61 6 Patent is satisfied. There only needs to 

be some initial pressure. Therefore, the scope of these two terms is not the same. 

The Federal Circuit’s discussion in Koito Mfg. Co., Ltd. v. Turn-key-tech, LLC, 381 F.3d 

1142 (Fed. Cir. 2004) is instructive. In Koito, the parties disputed the term “predetermined 

general direction” relating to plastic flow direction in injection molding. Id. at 1 145-48. The 

district court construed this term to mean that the direction must be chosen or at least known in 

advance of the injection, despite the plaintiffs argument that the term simply meant any 

direction following the shape of the mold cavity. Id. at 1 150. The Federal Circuit upheld the 

jury’s finding of non-infringement based on a showing that the defendant did not know 

beforehand (i. e., predetermined) the direction of its flow. Koito, 38 1 F.3d at 1 1 5 1. As in Koito, 

the term “predetermined” in the clams at issue requires actual knowledge of the pressure. Also, 

Indeed, the patentees use the term “predetermined pressure” repeated throughout the entire specification. (See 14 

generally JX-3 specification (‘6 16 Patent).) 

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PUBLIC VERSION 

as in Koito, it is not enough that one could later attempt to reconstruct the initial pressure or flow 

after the fact. Rather, one needs to know the amount of pressure that will be exerted on the hand 

when the glove is first donned. 

In sum, it is clear that Claim 1 of the ‘616 Patent is broader because the critical 

limitation of “decided in advance” has been omitted from the claim and because there are 

embodiments within the scope of the claim 1 of the ‘616 Patent that would not have been within 

the scope of the ‘362 Patent. As such, the asserted claims of the ‘616 Patent, independent claim 

1 and dependent claims 17, 18 and 19, which depend from claim 1, are invalid under 35 U.S.C. 3 

251,fl 4. 

C. Defective Reissue Certificate 

The provision for the reissue of defective patents is 35 U.S.C. 8 251 fl 1, which states: 

Whenever any patent is, through error without any deceptive intention, deemed 

wholly or partly inoperative or invalid, by reason of a defective specification or 

drawing, or by reason of the patentee claiming more or less than he had a right to 

claim in the patent, the Director shall, on the surrender of such patent and the 

payment of the fee required by law, reissue the patent for the invention disclosed 

in the original patent, and in accordance with a new and amended application, for 

the unexpired part of the term of the original patent. No new matter shall be 

introduced into the application for reissue. 

35 U.S.C. 3 251,v 1. “The reissue statute was not enacted as a panacea for all patent prosecution 

problems, nor as a grant to the patentee of a second opportunity to prosecute de novo his original 

application.” In re Weiler, 790 F.2d 1576, 1582 (Fed. Cir. 1986). Rather, the reissue procedure 

is only available to correct “error” in claims in patents as originally issued. Nupla Corp. v. LXL 

Mfg. Co., Inc., 114F.3d 191, 195 (Fed. Cir. 1997). “[Tlhe ‘error’ must only be the ‘claiming of 

more or less than he [or she] had a right to claim’ for some excusable reason.” Id. at 194. In light 

of these strictures, the reissue regulations require full explanation of what is claimed to be an 

“error” in the original claims. Id. at 195. 

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Under the reissue regulations in effect at the time that the reissue application at 

issue in this consolidated investigation was pending, an applicant was required to file a 

statement under oath or declaration as follows: (1) when the applicant verily believes the 

original patent to be wholly or partly inoperative or invalid, stating such belief and the 

reasons why; (2) when it is claimed that such patent is inoperative or invalid by reason of 

a defective specification or drawing, particularly specifying such defects; (3) when it is 

claimed that such patent is inoperative or invalid by reason of the patentee claiming more 

or less than he had a right to claim in the patent, distinctly specifying the excess or 

insufficiency in the claims; (4) particularly specifying the errors relied upon, and how 

they arose or occurred; (5) stating that such errors arose without any deceptive intention 

on the part of the applicant; and (6) acknowledging the duty to disclose all information 

known to the applicant to be material to patentability. See 37 C.F.R.9 1.175(a)(1996). 

See Dethmers Mfg. Co., Inc. v. Automatic Equipment Mfg. Co., 272 F.3d 1365, 1369 (Fed. Cir. 

2001). A patentee seeking reissue must also include in the reissue affidavit or declaration an 

explanation of how and when the asserted error was discovered. Hewlett-Packard Co. v. Bausch 

& Lomb Inc., 882 F.2d 1556, 1565 (Fed. Cir. 1989). 

As aptly noted by the Federal Circuit, “[tlhe Manual of Patent Examining Procedure, at 

1414.03, illustrate[d] the scope of the regulatory provision, by stating, in part: 

It is particularly important that the reissue oath or declaration specify in detail 

how the errors arose or occurred . . . . If the reissue oath or declaration does not 

particularly specify ‘how,’ i.e., the manner in which the errors arose or occurred, 

the Office will be unable to adequately evaluate reissue applicant’s statement in 

compliance with 9 1.175(a)(6) that the ‘errors arose “without deceptive intention” 

on the part of the applicant’. See 91414.04. 

Whether a declaration satisfies the requirements of 37 C.F.R. 9 1.175 is reviewed de novo, 

without deference to previous determinations of the U.S. Patent and Trademark Office. 

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Dethmers, 272 F.3d at 1370. When applicants fail to submit declarations satisfying these 

requirements, the affected reissue claims are invalid. See, e.g., Dethmers, 272 F.3d at 1374-76; 

Nupla, 114 F.3d at 194-95; In re Constant, 827 F.2d at 729, and Certain Magnetic Resonance 

Injection Systems and Components Thereof; Inv. No. 337-TA-434, Order No. 16 (October 17, 

2000). 

Respondents argue that the’616 Patent is invalid because of a deficient reissue declaration. 

(RIB at 15 .) Respondents argue that, assuming arguendo, that use of the term “predetermined 

pressure” was in error, Tillotson failed to comply with Rule 175, and all of the asserted claims 

are invalid. (Id. at 16.) Respondents argue that Tillotson failed to submit a statement under oath 

or declaration with its reissue application that “( 1) particularly specified that the use of the term 

“predetermined pressure” in Claim 1 of the original ’362 Patent was an error; (2) particularly 

specified how any purported error in using the term “predetermined pressure” arose or occurred; 

(3) specified when and how any purported error in using the term “predetermined pressure” in 

Claim 1 of the original ’362 Patent was discovered; and (4) stated that the purported error in 

using the term “predetermined pressure” in Claim 1 of the original ’362 Patent arose ‘without 

any deceptive intention on the part of the applicant.’” (Id. at 16.) Respondents Wher argue that 

Tillotson failed to state that the replacement of “predetermined” with “initial” was to correct an 

error or defect, but instead that the replacement was “to more clearly define the glove of claim 1 

in accordance with p. 11 line 22 of applicant’s description.” (Id. at 16, note 8.) Respondents 

argue that sincecclaims 17, 18 and 19 depend from claim 1 and Tillotson failed to comply with 

Rule 175, the asserted claims of the’616 Patent are invalid. (Id. at 16-17.) 

Tillotson counters that Respondents arguments rely on two incorrect premises. (CIB at 

59.) First, Tillotson argues that it was not required to separately explain the amendment from 

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“predetermined pressure” to “initial pressure’’ in a reissue declaration because it was a small 

language change that did not alter the scope of the claims. l5 (Id at 59.) Tillotson argues that the 

Federal Circuit has held that substitution of a term to clarify and more clearly describe the 

claimed invention does not materially change the scope of the claims and, as such, does not 

require a separate and detailed explanation. (Id. at 59-6 1 .) 

Second, Tillotson argues that the Supplemental Reissue Declaration adequately discussed 

the substitution of “initial” for “predetermined” by specifically addressing the change in the 

original claims and specifying how the reissue overcomes the defect. (Id. at 62.) Tillotson 

further argues that both the “Errors” section and the “Claim 1” section in the Supplemental 

Reissue discuss how the errors arose and were discovered by reference to the discussion of 

newly discovered prior art and states that all of the errors occurred without deceptive intent. (Id 

at 62-64.) 

Lastly, Tillotson argues that the patent examiner fully considered and allowed the 

substitution of “initial” for “predetermined” to clarify claim 1 ; that the examiner did not find a 

deficiency with the substitution in the Supplemental Reissue Declaration since she did not 

specifically point the substitution out as a deficiency as required by the MPEP; and that the fact 

that the examiner accepted the substitution weighs heavily against a finding of invalidity on that 

basis. l6 (Id. at 61-66.) 

l5 Tillotson cites to the statement in both the Reissue Declaration and Supplemental Reissue Declaration that 

plainly states that the substitution of “initial” for “predetermined” was “to more clearly define the glove of claim 1 

in accordance with p. 11 line 22 of the description.” (CIB at 61, JX-4 at TLC000034-35 (‘616 Prosecution History).) 

In its reply brief, Tillotson asserts a new argument for the first time. In Section I11 B-D, Tillotson argues for the 

first time that a deficient reissue declaration is not an invalidity defense under 35 U.S.C. 4 282; allowing a deficient 

reissue declaration to invalidate the ‘6 16 Patent would be unjust; and Rule 1.175 exceeds the PTO’s authority and is 

invalid. (CRB at 8-16.) Tillotson’s Reply Brief Section I11 B-D is subject to a motion to strike by Ansell. (Motion 

Docket No. 608-158.) For the reasons set forth in Order No. 93, the Court GRANTED Ansell’s motion to strike. 

(See Order No. 93) 

16 

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Staff agrees with Respondents and argues that the ‘6 16 Patent is invalid based on 

deficient reissue declaration. (SIB at 42.) Staff argues that neither the Reissue Declaration nor 

the Supplemental Reissue Declaration specifies that the use of “predetermined pressure” was in 

error. (Id at 45.) Staff argues that the Supplemental Reissue Declaration fails to state in its 

“Summary” section or in the “Claim 1 ” “The Errors” subsection that the use of “predetermined 

pressure” was in error. (Id. at 45-46.) Staff further argues that even if Mr. Tillotson’s statement 

that ‘‘[tlhe term ‘predetermined’ has been replaced with the term ‘initial’ in amended claim 1 to 

more clearly define the glove of claim 1. . . .” (JX-4 at TLCOOO 178 (‘6 16 Prosecution History)) 

were to be accepted as a statement of error, the other reissue requirements still have not been 

satisfied, “including specifying how any such error arose or occurred and when and how any 

such error was discovered.” (SIB 46.) Staff hrther argues that Tillotson’s explanation of the 

reason for the substitution is absent from the Reissue Declaration and Supplemental Reissue 

Declaration, despite Tillotson’s explanation in response to a motion in this investigation. (Id. at 

46.) 

Staff further argues that the one of ordinary skill in the art would not consider the change 

from “predetermined” to “initial” to be a small change in language that does not affect the scope 

of the claims such that no explanation in the reissue declaration is required. (Id. 46-47.) Staff is 

of the view, therefore, that the clear and convincing evidence shows that the reissue certificate is 

defective and the reissued claims are invalid. (Id. at 47.) 

During the prosecution of the reissue application, Mr. Tillotson submitted a Reissue 

Declaration for the ‘616 Patent. (JX-4 at TLC00029-50 (‘616 Prosecution History).) The patent 

examiner found the Reissue Declaration to be defective for failure to meet the requirements of 37 

C.F.R. $ 1.175 and rejected all ofthe claims in the reissue application. (Id at TLC000146-160.) 

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In response to the first Office Action, Mr. Tillotson filed a Supplemental Reissue Declaration 

that addressed the deficiencies cited by the examiner. (Id. at TLCOOOl71-184.) 

In the “Summary” section of the Supplemental Reissue Declaration, Mr. Tillotson 

describes the “errors” that prompted the reissue and stated: 

I believe the original US. Patent 5,O 14,362 (hereinafter “the Original 

Patent”) to be partly inoperative or invalid by reason of Patentee claiming 

more than Patentee had a right to claim in the Original Patent, an 

inadvertent drafting error, and the specification not providing proper 

antecedent basis for a claim as amended by this reissue application. More 

particularly, the claims of the Original Patent are too broad in view of prior art 

that has come to the attention of the Applicant and its attorneys since issuance of 

the Original Patent. The prior art includes elastomeric gloves, both nitrile rubber 

and natural rubber gloves, that have relaxation properties such that the prior art 

gloves would relax fiom an initial pressure to a reduced pressure substantially less 

than 80% of the initial pressure. This prior art is cited in the Information 

Disclosure Statement filed with the reissue application. In addition, due to an 

inadvertent drafting error, one of the dependent claims of the Original Patent, 

claim 15, broadens the independent claim of the Original Patent, by broadening 

the degree of relaxation described, instead of narrowing the degree of relaxation 

as was intended. These errors in the Original Patent claims and specification, 

described generally above and in detail below, arose without any deceptive 

intention on the part of the Applicant. 

With the Amendment to be filed concurrently with this Supplemental Reissue 

Declaration and Power of Attorney, claims 1,2,7, 14 and 15 of the Original 

Patent are amended, new claims 17-24 are added, claims 12, 13, and 16 of the 

Original Patent are cancelled, and claims 25-43 initially added in the reissue 

application are cancelled. The claims of the reissue patent application now define 

a glove which I believe is novel and nonobvious over the prior art cited in the 

Information Disclosure Statement. 

(JX-4 at TLCOOOl84A-N (‘616 Prosecution History)) (emphasis added).I7 There is no mention, 

however, of replacing the term “predetermined” with “initial.” 

In the “Claim 1 ” section, “The Errors” subsection, of the Supplemental Reissue 

Declaration, Mr. Tillotson fkther stated, inter alia, that “[Cllaim 1 of the Original Patent does 

The Supplemental Reissue Declaration begins on TLCOOO171-184, but it appears that a page is missing. The full 17 

Supplemental Reissue Declaration was submitted to the PTO and immediately follows on TLCOOOl 84A-N. (JX-4 

(‘6 16 Prosecution History).) 

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not specify the chemical nature of the elastomer, the type of fit of the glove, or the thickness of 

the elastomeric material from which the glove is made.” (JX-4 at TLC000184C (‘616 

Prosecution History).) Mr. Tillotson then proceeds to explain the prior art and how the ‘362 

Patent is too broad in light of the prior art. (Id. at TLCOOOl84C-E.) Mr. Tillotson concludes by 

stating that “Claim 1 of the Original Patent is defective in that it does not specify the chemical 

name of the elastomer, does not clearly define the fit of the glove, does not clearly define the 

thickness of the glove, and describes the relaxation properties of the glove too broadly.” (Id. at 

TLCOOO 1 84C-E.) Again, there is no mention of replacing the term “predetermined” with 

“initial .” 

In the “How and When Errors Occurred” and “How and When the Errors Were 

Discovered” subsections, Mr. Tillotson again makes no mention of replacing the term 

“predetermined” with “initial.” (JX-4 at TLCOOOl84E-G (‘61 6 Prosecution History).) The first 

mention of replacing the term “predetermined” with “initial” comes under the subsection titled 

“Amended Claim 1 ,” where Mr. Tillotson states: 

Amended claim 1 differs from Claim 1 of the original patent in that 

amended claim 1 describes a glove which is closely fitting and comprises a later 

of elastomeric material which fits closely about a hand, comprises nitrile 

butadiene rubber, has an initial configuration adapted to fir closely about a hand, 

and has a thickness and elastic properties such that the glove is capable of being 

stretched to fit closely about the hand and when stretched from an initial 

configuration to fit closely about the hand, exerts an initial, rather than 

predetermined, pressure on the hand, and thereafter still fits closely about the 

hand, but relaxes, within about 6 minutes after the glove is stretched to fit about 

the hand, to exert on the hand a reduced pressure which is less than about 50% of 

the initial pressure, rather than a reduced pressure which is merely substantively 

less than about 80 % of the initial pressure. These changes to claim 1 are 

discussed in more detail below. 

More particularly, amended claim 1 defines the glove as having an initial 

configuration adapted to receive and fit closely about a hand. The term 

“predetermined” has been replaced with the term “initial” in amended claim 

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1 to more clearly define the glove of claim 1 in accordance with p. 11 line 22 

of the applicant’s description [i.e., the 100% modulus test]. . . . 

.... 

The amendments of claim 1 overcome the defects of the Original 

Patent by specifying the chemical name of the elastomer, further defining the 

fit of the glove, and further defining the thickness and elastomeric properties 

of the glove, including the degree of relaxation of the glove. . . . 

(Id. at TLCOOO 184H-I.) (emphasis added). However, there is no mention or explanation of how 

the use of “predetermined pressure” in the ‘362 Patent was in error. Rather, Mr. Tillotson 

explains that the use of “initial” was intended to “more clearly define the glove” in accordance 

with the 100% modulus test. (Id at TLCOOO 184H.) Tillotson argues that this is sufficient to 

explain “how the reissue declaration overcomes the defect” and “how the amended claim differs 

from the [‘362 Patent].” (CIB at 62.) The Court disagrees. First, there is no indication in the 

Supplemental Reissue Declaration or even the original Reissue Declaration that the use of 

“predetermined” instead of “initial” in the ‘362 Patent was actually a defect. In addition, this 

statement does not show that “predetermined” was erroneously used, nor does it explain how or 

why “predetermined” was erroneously used, or how it was discovered that “predetermined” was 

erroneously used. (See 37 C.F.R. 3 1.175(a).) 

The “error” that the inventors sought to correct does not become clear until this 

investigation. In response to Ansell’s Motion for Summary Determination of Invalidity of the 

Asserted Claims of the ‘6 16 Patent By Reason of Broadening Amendment More Than Two 

Years After the Issuance of the Original Patent, Tillotson stated that it “realized that 

‘predetermined pressure’ could be misinterpreted to mean something other than ‘initial pressure” 

and that this “possible misinterpretation” constituted the error that Tillotson corrected in the 

Reissue Patent. (Tillotson’s Opposition Motion for Summary Determination of Invalidity of the 

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Asserted Claims of the ‘6 16 Patent By Reason of Broadening Amendment More Than Two 

Years After the Issuance of the Original Patent at 31; see also Tillotson, Tr. 1228:8-19.) This 

explanation, however, does not cure the deficient reissue declaration or Tillotson’s failure to 

explain the “error” of mistakenly using “predetermined” instead of “initial” in claim 1 of the 

‘362 Patent during the reissue application process. 

Tillotson argues that “[tlhe substitution of ‘initial’ for “predetermined” in amended claim 

1 , . . is the correction of an error that is allowed during reissue. Because this correction is a 

‘small language change{ } that {did) not affect the scope of the claims,’ however, it is not a 

change that must be separately ‘explained in the reissue declaration.”’ (CIB at 61 .) Based on the 

Court’s ruling supra Section V.B., the substitution of “initial” for “predetermined” in claim 1 

significantly changed the scope of the claims. It was not a simple clarification, but instead 

broadened the scope of the claims and, as such, is not a “small language change.” In addition, 

the substitution of “initial” for “predetermined”, where it was repeatedly used in the specification 

and claims of the ‘362 Patent hardly seems to be a “small” language change, especially when 

such a change occurs in the only independent claim of the patent. Moreover, the use of the 

phrase “initial, rather than predetermined, pressure” indicates a change of meaning and not a 

mere substitution of words. 

Based on the reasons set forth above, the Court finds that the evidence clearly and 

convincingly shows that Tillotson failed to submit a reissue declaration that specified that the use 

of “predetermined pressure” in claim 1 of the ‘362 Patent was an error, failed to specify how the 

erroneous use of the term “predetermined pressure” arose or occurred, or how it was discovered 

that “predetermined” was erroneously used. Therefore, the asserted claims of the ‘616 Patent are 

invalid based on a deficient reissue declaration. 

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D. Anticipation 

A patent may be found invalid as anticipated under 35 U.S.C. Q 102(a) if “the invention 

was known or used by others in this country, or patented or described in a printed publication in 

this country, or patented or described in a printed publication in a foreign country, before the 

invention thereof by the applicant for patent.” 35 U.S.C. Q 102(a). A patent may be found invalid 

as anticipated under 35 U.S.C. 0 102(b) if “the invention was patented or described in a printed 

publication in this or a foreign country or in public use or on sale in this country, more than one 

year prior to the date of the application for patent in the United States.” 35 U.S.C. Q 102(b). 

Under 35 U.S.C. Q 102(e), a patent is invalid as anticipated if “the invention was described in a 

patent granted on an application for patent by another filed in the United States before the 

invention thereof by the applicant for patent.” 35 U.S.C. Q 102(e). Anticipation is a question of 

fact. Texas Instruments, Inc. v. US. Int’l Trade Comm’n, 988 F.2d 1165, 1177 (Fed. Cir. 1993) 

(“Texas Instruments If’). While anticipation is a question of fact, it is determined by properly 

construing the claims and then comparing the claims, as construed, to the prior art. In re 

Cruciferous Sprout Litig., 301 F.3d 1343, 1346 (Fed. Cir. 2002). It is axiomatic that claims are 

construed the same way for both invalidity and infringement. W.L. Gore v. Garlock, Inc., 842 

F.2d 1275,1279. 

In order to prove anticipation, Respondents must present clear and convincing evidence 

that a single prior art reference discloses, either expressly or inherently, each limitation of the 

claim. Cruciferous Sprout, 301 F.3d at 1349. A claim is anticipated and therefore invalid when 

“the four corners of a single, prior art document describe[s] every element of the claimed 

invention, either expressly or inherently, such that a person of ordinary skill in the art could 

practice the invention without undue experimentation.” Advanced Display Sys., Inc. v. Kent 

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PUBLIC VERSION 

State Univ., 212 F.3d 1272, 1282 (Fed. Cir. ZOOO), cert. denied, 532 U.S. 904 (2001). To be 

considered anticipatory, the prior art reference must be enabling and describe the applicant’s 

claimed invention sufficiently to have placed it in possession of a person of ordinary skill in the 

field of the invention. HeliJx Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000); In re 

Paulsen, 30 F.3d 1475, 1478 (Fed. Cir. 1994). But, the degree of enabling detail contained in the 

reference does not have to exceed that contained in the patent at issue. Paulsen, 30 F.3d at 1481 

n.9. 

Further, the disclosure in the prior art reference does not have to be express, but may 

anticipate by inherency where the inherency would be appreciated by one of ordinary skill in the 

art. Glmo Inc. v. Novopharm Ltd, 52 F.3d 1043,1047 (Fed. Cir.), cert. denied, 516 U.S. 988 

(1 995). To be inherent, the feature must necessarily be present in the prior art. See Finnigan 

Corp. v. US. Int’Z Trade Comm’n, 180 F.3d 1354, 1365-66 (Fed. Cir. 1999). Inherency may not 

be established by probabilities or possibilities. The mere fact that a certain thing may result from 

a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show 

that the natural result flowing from the operation as taught would result in the performance of the 

questioned hction, it seems to be well settled that the disclosure should be regarded as 

sufficient. This modest flexibility in the rule that “anticipation” requires that every element of 

the claims appear in a single reference accommodates situations where the common knowledge 

of technologists is not recorded in the reference; that is, where technological facts are known to 

those in the field of the invention, albeit not known to judges. See Cont ’I Can Co. v. Monsanto 

Co., 948 F.2d 1264, 1268-69 (Fed. Cir. 1991); Finnigan, 180 F.2d at 1365. 

Respondents argue that the ‘616 Patent is invalid as anticipated by U.S. Patent No. 

2,880,189 (“the Miller Patent”). Respondents argue that the Miller Patent contains all the 

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information one of ordinary skill in the art would need to manufacture what was claimed in the 

‘616 Patent. (RIB at 37.) Respondents argue that PTO found the ‘616 Patent as anticipated by 

the Miller Patent because while the Miller Patent failed to disclose specific relaxation values, the 

relaxation data submitted by the inventors on Miller Patent sample showed them to be 

sufficiently close to those of the ‘616 Patent. (Id. at 38.) Respondents further argue that the 

inventors effectively conceded that the Miller Patent contained all of the limitation of the ‘6 16 

Patent by failing to argue that the Miller Patent did not contain all of the limitations of the ‘6 16 

Patent. (Id. at 39.) Respondents argue that, instead, the inventors merely argued that the Miller 

Patent failed to give one of ordinary skill in the art the means and motivation to enhance the 

relaxation properties of the Miller Patent invention. (Id. at 39.) 

Tillotson argues that Respondents have failed to prove anticipation by the Miller Patent. 

(CIB at 3 1 .) As an initial matter, Tillotson argues that Respondents’ arguments ignore the fact 

that the PTO had considered the Miller Patent during the prosecution of the reissue application 

and had found that the Miller Patent did not anticipate the ‘61 6 Patent. (Id. at 3 1 .) Tillotson 

fbrther argues that the Miller Patent does not anticipate the ‘616 Patent because the ‘616 Patent 

contains numerous claim limitations that the Miller Patent does not, such as providing a targeted 

amount of relaxation, i.e. a reduced pressure that is 50% of the initial pressure, and providing for 

a closely fitting glove of certain tensile strength, elasticity and thickness that is impermeable to 

water and water vapor. (Id. at 32.)” 

Staff argues that Respondents have failed to show by clear and convincing evidence that 

the Miller Patent anticipates the ‘616 Patent. (SIB at 29.) Staff argues that the relaxation 

l8 Tillotson then discusses that the ‘616 Patent is not inherently anticipated by the Zeon reference and Dr. Mill’s 

testimony regarding the same. (CIB at 33-35.) However, Respondents have made no inherency argument (see RIB 

at 33-45) and, in fact, notified Staff and Tillotson of their decision not to rely on the Zeon data for any purpose (SIB 

at 30.) As such, the Court finds that Respondents have waived any arguments that assert that the Miller Patent 

inherently discloses the relaxation limitations of the ‘6 16 Patent. (See Ground Rule 1 1. I .) 

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properties of the ‘616 Patent are not taught or suggested by the Miller Patent. (Id. at 29-30.) 

Staff further argues that other limitations in the ‘616 Patent are not disclosed in the Miller Patent, 

namely “a closely fitting glove (or any other nitrile composition) that relaxes from an initial 

pressure to a reduced pressure that is less than about 50% of the initial pressure within about six 

minutes after the glove is donned.” (Id. at 30.) Staff further argues that the Miller Patent fails to 

discuss stress relaxation or how to use metal oxides to manipulate the relaxation and it further 

fails to discuss the resilience or relaxation behavior of the elastomers. (Id. at 30.) Staff further 

argues that Dr. Mills testimony regarding the nitrile films disclosed in the Miller Patent are 

unsupported and that they are contradicted by the inventors’ own Miller Patent samples and data. 

(Id. at 30-31.) 

The Court finds that Respondents have failed to show by clear and convincing evidence 

that the Miller Patent discloses each claim limitation of claim 1 of the ‘616 Patent. The Miller 

Patent was considered during the prosecution of the ‘6 16 Patent, but the examiner still found the 

‘616 Patent to be patentable over the prior art. (JX-4 at TLCOOO150-152; TLC000160 (‘616 

Prosecution History)); See Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F. 2d 1464, 1467 

(Fed. Cir. 1990) (particularly heavy burden in establishing invalidity on the same prior art that 

was examined in the PTO). The evidence shows that the Miller Patent fails to disclose the 

several limitations of the ‘6 16 Patent including the relaxation limitation of relaxing to less than 

about 50% of the initial pressure. (Rx-5; CX-839C at 83,95, 107 (Moalli Rebuttal); Mills, Tr. 

866:3-13.) The evidence further shows that the Miller Patent fails to discuss the relaxation or 

resilience behaviors of the elastomers described therein or even disclose a closely fitting glove 

(RX-5; CX-839C at Q&A 88,91-92, 107 (Moalli Rebuttal); Mills, Tr. 866:3-13.) Moreover, 

even assuming that relaxation was disclosed in the Miller Patent, the patentee’s experiments on 

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the Miller Patent samples shows that they did not meet the relaxation limitations of the ‘616 

Patent because they relaxed to only 63-64% of their initial stress. (JX-4 at TLC00040,44- 

49,174-175,180 (616 Prosecution History); CX839C at Q&A 150,161-163,285-188 (Moalli 

Rebuttal).) Therefore, the Court finds that the evidence shows that the Miller Patent fails to 

disclose all of the limitations in independent claim 1 of the ‘616 Patent. 

E. Obviousness 

Obviousness is grounded in 35 U.S.C. 5 103, which provide, inter alia, that: 

A patent may not be obtained though the invention is not identically disclosed or 

described as set forth in section 102 of this title, if the differences between the 

subject matter sought to be patented and the prior art are such that the subject 

matter as a whole would have been obvious at the time the invention was made to 

a person having ordinary skill in the art to which said subject matter pertains. 

Patentability shall not be negative by the manner in which the invention was made. 

35 U.S.C. 8 103(a). Under 35 U.S.C. 9 103(a), a patent is valid unless “the differences between 

the subject matter sought to be patented and the prior art are such that the subject matter as a 

whole would have been obvious at the time the invention was made to a person having ordinary 

skill in the art to which said subject matter pertains.” 35 U.S.C. 9 103(a). The ultimate question 

of obviousness is a question of law, but “it is well understood that there are factual issues 

underlying the ultimate obviousness decision.” Richardson-Vicks Inc., 122 F.3d at 1479; Wang 

Lab., Inc. v. Toshiba Corp., 993 F.2d 858,863 (Fed. Cir. 1993). 

Once claims have been properly construed, “[tlhe second step in an obviousness inquiry 

is to determine whether the claimed invention would have been obvious as a legal matter, based 

on underlying factual inquiries including: (1) the scope and content of the prior art, (2) the level 

of ordinary skill in the art, (3) the differences between the claimed invention and the prior art; 

and (4) secondary considerations of non-obviousness” (also known as “objective evidence”). 

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Smiths Indus. Med. Sys., Inc. v. Vital Signs, Inc., 183 F.3d 1347, 1354 (Fed. Cir. 1999), citing 

Graham v. John Deere Co., 383 U.S. 1, 17 (1966). 

The Federal Circuit case law required that, in order to prove obviousness, the patent 

challenger must demonstrate, by clear and convincing evidence, that there is a “teaching, 

suggestion, or motivation to combine. The Supreme Court has rejected this “rigid approach” 

employed by the Federal Circuit in KSR Int’l Co. v. Telefex Inc., 500 U.S. - (2007), 127 S.Ct. 

1727, 1739. The Supreme Court stated: 

When a work is available in one field of endeavor, design incentives and other 

market forces can prompt variations of it, either in the same field or a different 

one. If a person of ordinary skill can implement a predictable variation, 4 103 

likely bars its patentability. For the same reason, if a technique has been used to 

improve one device, and a person of ordinary skill in the art would recognize that 

it would improve similar devices in the same way, using the technique is obvious 

unless its actual application is beyond his or her skill. Sakraida and Anderson’sBlack Rock are illustrative-a court must ask whether the improvement is more 

than the predictable use of prior art elements according to their established 

fimction. 

Following these principles may be more difficult in other cases than it is here 

because the claimed subject matter may involve more than the simple substitution 

of one known element for another or the mere application of a known technique to 

a piece of prior art ready for the improvement. Often, it will be necessary for a 

court to look to interrelated teachings of multiple patents; the effects of demands 

known to the design community or present in the marketplace; and the 

background knowledge possessed by a person having ordinary skill in the art, all 

in order to determine whether there was an apparent reason to combine the known 

elements in the fashion claimed by the patent at issue. To facilitate review, this 

analysis should be made explicitly. See In re Kahn, 441 F.3d 977,988 (CA Fed. 

2006) (“[Rlejections on obviousness grounds cannot be sustained by mere 

conclusory statements; instead, there must be some articulated reasoning with 

some rational underpinning to support the legal conclusions of obviousness”). As 

our precedents make clear, however, the analysis need not seek out precise 

teachings directed to the specific subject matter of the challenged claim, for a 

court can take account of the inferences and creative steps that a person of 

ordinary skill in the art would employ. 

L.1 

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The obviousness analysis cannot be confined by a formalistic conception of the 

words teaching, suggestion, and motivation, or by overemphasis on the 

importance of published articles and the explicit content of issued patents. The 

diversity of inventive pursuits and of modern technology counsels against limiting 

the analysis in this way. In many fields it may be that there is little discussion of 

obvious techniques or combinations, and it often may be the case that market 

demand, rather than scientific literature, will drive design trends. Granting patent 

protection to advance that would occur in the ordinary course without real 

innovation retards progress and may, in the case of patents combining previously 

known elements, deprive prior inventions of their value or utility. 

KSR, 550 US. at - ; 127 S.Ct. at 1740-41. 

“Secondary considerations,” also referred to as “objective evidence of non-obviousness,” 

such as “commercial success, long felt but unsolved needs, failure of others, etc.” may be used to 

understand the origin of the subject matter at issue, and may be relevant as indicia of 

obviousness or non-obviousness. Graham, 383 U.S. at 17-1 8. Secondary considerations may 

also include copying by others, prior art teaching away, and professional acclaim. See PerkinElmer Corp. v. Computervision Corp., 732 F.2d 888,894 (Fed. Cir. 1984), cert. denied, 469 U.S. 

857 (1984); Avia Group Int’l, Inc. v. L.A. Gear California, 853 F.2d 1557, 1564 (Fed. Cir. 1988) 

(copying by others); In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986) (prior art teaching away; 

invention contrary to accepted wisdom); Kloster Speedsteel AB v. Crucible Inc., 793 F.2d 1565 

(Fed. ir. 1986), cert. denied, 479 U.S. 1034 (1 987) (wide acceptance and recognition of the 

invention). 

Evidence of “objective indicia of non-obviousness,” also known as “secondary 

considerations,” must be considered in evaluating the obviousness of a claimed invention, but the 

existence of such evidence does not control the obviousness determination. A court must 

consider all of the evidence under the Graham factors before reaching a decision on obviousness. 

Richardson-Vicks Inc., 122 F.3d at 1483-84. In order to accord objective evidence substantial 

weight, its proponent must establish a nexus between the evidence and the merits of the claimed 

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invention, and a prima facie case is generally made out “when the patentee shows both that there 

is commercial success, and that the thing (product or method) that is commercially successful is 

the invention disclosed and claimed in the patent.” In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. 

Cir. 1995); Demaco Corp. v. F. Von LangsdorffLicensing Ltd, 851 F.2d 1387, 1392 (Fed. Cir. 

1988), cert. denied, 488 US. 956 (1988); Certain Crystalline Cefadroxil Monohydrate, Inv. No. 

337-TA-293, Commission Opinion (March 15, 1990),15 U.S.P.Q.2d 1263, 1270 (“Certain 

Crystalline”). Once the patentee has made a prima facie case of nexus, the burden shifts to the 

challenger to show that the commercial success was caused by “extraneous factors other than the 

patented invention, such as advertising, superior workmanship, etc.” Id at 1393. 

The Federal Circuit has harmonized the KSR opinion with many prior circuit court 

opinions by holding that when a patent challenger contends that a patent is invalid for 

obviousness based on a combination of prior art references, “the burden falls on the patent 

challenger to show by clear and convincing evidence that a person of ordinary skill in the art 

would have had reason to attempt to make the composition or device, or carry out the claimed 

process, and would have had a reasonable expectation of success in doing so. PharmaStem 

Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007)(citing Medichem S.A. v. 

Rolabo S.L., 437 F.3d 1175, 1164 (Fed. Cir. 2006)); Noelle v. Lederman, 355 F.3d 1343, 1351- 

52 (Fed. Cir. 2004); Brown & Williamson Tobacco Corp. v. Philip Morris, Inc., 229 F.3d 1120, 

1121 (Fed .Cir. 2000) and KSR, 127 S.Ct. at 1740 (“a combination of elements ‘must do more 

than yield a predictable result’; combining elements that work together ‘in an unexpected and 

fruitful manner’ would not have been obvious”). 

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The ultimate determination of whether an invention would have been obvious is a legal 

conclusion based on underlying findings of fact. In re Dembiczak, 175 F.3d 994,998 (Fed. Cir. 

1999). 

1. Analysis of the Asserted Claims 

Respondents argue that the ‘616 Patent is obvious in light of the prior art, namely the 

Miller Patent and U.S. Patent No. 3,094,704 (“the Abildgaard Patent”), prior art gloves available 

on the market and common knowledge about latex rubber chemistry and rubber c~mpounding.’~ 

(RIB at 33-34.) Specifically, Respondents argue that closely fitting rubber articles, with good 

relaxation and without excess pressure on the wearer, were known in the art; that high resilience 

and low relaxation were only desirable depending on the use of the article in question; and that 

there were a number of contemporaneous patent applications for which low stress relaxation was 

not desirable. (Id. at 34-35.) 

Respondents argue that the asserted claims 1,17, 18 and 19 are obvious in light of the 

Miller Patent combined with what of one of ordinary skill in the art knew about modifying 

material to achieve specific elastic and relaxation properties. (Id. at 37-38.) Respondents further 

argue that in light of the Supreme Court’s decision in KSR, the need to show a teaching, 

suggestion or motivation to enhance the relaxation properties of the Miller Patent need not be 

shown. (Id at 39.) Instead, it is sufficient to show that market pressures andor designs would 

lead one of ordinary skill in the art to try a finite number of identified, predictable solutions to 

arrive at what was claimed in the ‘616 Patent. (Id. at 39-40.) Respondents argue that the two 

phenomena contemporaneous with the application for the ‘6 16 Patent, namely the natural rubber 

Respondents further argue that the Abildgaard Patent combined with other prior art Wher renders the ‘616 Patent 19 

obvious. (RIB at 44-45, RX-156.) However, the Court finds no evidence of the Ablidgaard Patent in Respondents’ 

pre-hearing brief or testimony during the hearing relating to this prior art. (See Respondents’ prehearing brief at 

106-123.) Therefore, the Court finds that, pursuant to Ground Rule 8(Q, Respondents have waived any argument 

related to the Abildgaard Patent. 

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latex allergies of healthcare providers and the AIDS epidemic, would have made the creation of 

nitrile butadiene rubber gloves obvious to one of ordinary skill in the art. (Id. at 40.) 

Respondents fkther argue that the Miller Patent combined with the gloves commercially 

available during the prosecution of the ‘616 Patent, namely the SOLVEXB and DERMATHINTM gloves, would render the ‘616 Patent obvious. (Id. at 41 .) Respondents argue that the 

thickness, stress relaxation, and tensile strength properties of the ‘6 16 Patent were already 

present in the combination of the Miller Patent and the SOLVEX@ and DERMA-THINTM gloves. 

(Id. at 41-44.) Specifically, Respondents argue that the DERMA-THINTM glove disclosed a 

closely fitting glove with a tensile strength of at least 1500 psi, the SOLVEXB glove disclosed a 

nitrile butadiene rubber glove with a tensile strength of 1500 psi and relaxation properties such 

as those in the ‘616 Patent, and the Miller Patent disclosed a 5mil glove, all of which combined 

with the understanding of the alteration of chemical properties would lead one of ordinary skill 

in the art to find the ‘616 Patent obvious. (Id at 43-44.) 

Tillotson argues that the Miller Patent, alone or in combination with the state of art, fails 

to render the ‘616 Patent obvious. (CIB at 38.) Tillotson argues that the SOLVEXB glove is a 

fundamentally different glove from that of the ‘616 Patent, namely that it is a thick, stiff, loosefitting industrial glove that cannot be stretched to fit about a hand and will restrict blood flow. 

(Id at 38-39.) Tillotson argues that the DERMA-THINTM glove is a natural rubber glove that 

only relaxes to 67% of its initial stress after 6 minutes and, as such, fails to meet the relaxation 

and nitrile butadiene limitations of the ‘616 Patent glove. (Id. at 39-40.) Tillotson further argues 

that the state of the art teaches away from the ‘616 Patent because it taught that stress relaxation 

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was an undesirable feature and it taught the use of high levels of zinc oxide when making nitrile 

films2’ (Id. at 40.) 

Staff argues that the Miller Patent alone does not render the ‘616 Patent invalid for 

obviousness based on the same reasons that the Miller Patent fails to render the ‘616 Patent 

anticipated and invalid. (SIB at 32.) Staff argues that the physical and mechanical differences 

between the glove claimed in the ‘616 Patent and the SOLVEX@ and DEW-THINTM gloves 

fails to render the ‘616 Patent obvious, even in combination with the Miller Patent. (Id. at 32, 

note 27.) Staff further argues that the state of the art also fails to render the ‘616 Patent obvious 

because it did not teach the combination of thickness, modulus, tensile strength and relaxation 

that would create a close fitting glove that solved the squeezing caused by pressure on the hand. 

(Id. at 33.) Staff further argues that the ‘616 Patent solved the long standing problem of a close 

fitting glove that applied excessive pressure on the hand by using a solution, i.e., stress relaxation 

to reduce pressure, that ran against conventional thought, which taught that relaxation was an 

undesirable feature of rubber composition. (Id. at 33.) Staff fiu-ther argues that the use of the 

relaxation characteristics of nitrile rubber to solve the squeezing problem on the hand by a 

closely fitting glove and the level of relaxation taught in the ‘616 Patent was not known at the 

time of the invention. (Id. at 34.) 

The Court finds that Respondents have failed to show by clear and convincing evidence 

that the ‘6 16 Patent is obvious in light of the prior art, including the Miller Patent, alone, or in 

combination with the SOLVEX@ and DERMA-THTNTM gloves. As an initial matter, 

Respondents argue that the “teaching, suggestion, or motivation” test has been completely 

“eviscerated” in light of the Supreme Court’s decision in KSR. (NU3 at 21 .) Respondents 

blatantly ignore the language of KSR, which still requires that there still needs to be a “reason to 

*’ The ‘6 16 Patent teaches the use of lower zinc oxide levels. (CIB at 40.) 

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combine the known elements in the fashion claimed by the patent at issue.” KSR, 127 S. Ct. at 

173 1. Respondents also ignore the Federal Circuit’s recent decisions, which still use the 

“teaching, suggestion or motivation” test under a flexible approach rather than the past rigid 

approach, which was rejected by the Supreme Court. (See Ortho-McNeil Pharmaceutical, Inc. v. 

Mylan Laboratories, Inc., 520 F.3d 1358, 1364-65 (Fed. Cir. 2008) (“The TSM test, flexibly 

applied, merely assures that the obviousness test proceeds on the basis of evidence--teachings, 

suggestions (a tellingly broad term), or motivations (an equally broad term)--that arise before the 

time of invention as the statute requires. As KSR requires, those teachings, suggestions, or 

motivations need not always be written references but may be found within the knowledge and 

creativity of ordinarily skilled artisans.”); Takeda Chem. Indus., Ltd. v. Alphapharm Pty. Ltd., 

492 F.3d 1350, 1356-1357 (Fed Cir. 2007); In re Translogic Tech., Inc., 504 F.3d 1249, 1257 

(Fed. Cir. 2007.)) 

The Court finds that Respondents have failed to show how one of ordinary skill in the art 

with knowledge of modifying material to achieve certain elastic and relaxation properties would, 

combined with the Miller Patent, come up with the ‘6 16 Patent. Respondents argue that market 

forces would motivate one to modify the Miller Patent. Respondents have, however, failed to 

show how the Miller Patent combined with market forces of natural rubber latex allergies and the 

AIDS epidemic would lead one of ordinary skill in the art to create a closely fitting glove that 

relaxed to a reduced pressure of less than 50% of the initial pressure. (See RIB at 37-41; RRB at 

20-22.) In other words, even assuming Respondents’ argument of “evisceration” of the 

“teaching, suggestion, or motivation” test were correct, the Respondents still have failed to 

provide a correlation between, at a minimum, the relaxation properties of the ‘6 16 Patent and 

natural rubber latex allergies and the AIDS epidemic. Moreover, the Miller Patent was 

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considered by the patent examiner during the prosecution of the ‘616 Patent, but the examiner 

still found the ‘616 Patent to be patentable. (JX-4 at TLCOOO150-152; TLC000160 (‘616 

Prosecution History)); See Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F. 2d 1464, 1467 

(Fed. Cir. 1990) (particularly heavy burden in establishing invalidity on the same prior art that 

was examined in the PTO). 

The Court further finds that the Miller Patent, in combination with the SOLVEX@ and 

DERMA-THINTM gloves fails to render the ‘616 Patent obvious. The Miller Patent combined 

the SOLVEX@ and DERMA-THINTM gloves were considered by the patent examiner during the 

prosecution of the ‘616 Patent, but, as noted above, the examiner still found the ‘616 Patent to be 

patentable. (JX-4 at TLCOOO 1 50- 152; TLC000 160 (‘6 16 Prosecution History)). The evidence 

shows that these prior art references fail to disclose various limitations of the ‘6 16 Patent. The 

SOLVEX@ glove is a thick, stiff, loose-fitting industrial glove; the DERMA-THINTM glove is a 

natural rubber glove that did not exhibit the relaxation properties of the claimed glove; and the 

Miller Patent fails to teach a glove that includes the relaxation properties disclosed in the ‘616 

Patent. (Id. at TLC00040-50, TLC000184G-L; CX-839C at Q&A 83,95, 107-8,275,282-83, 

288,333-37 (Moalli Rebuttal); Moalli, Tr. 1455:13-1456:14; Mills Tr. 866:6-13.) Moreover, 

Respondents fail to point to any reason to combine these different prior art references.21 (See 

RIB at 4 1-44; RRB at 20-23 .) Rather, the state of the art actually teaches away from the ‘6 16 

Patent by teaching that stress relaxation was undesirable and that low stress relaxation was 

preferred. (CX-839C at Q&A 30-34, 71 -76, 1 10; Mills, Tr. 867: 17-868: 17; Moalli Tr. 1546: 13- 

24, 1602:16-1603:lO; Rx-183; Moalli, Tr. 1544:s-14; RX-12.) 

Tillotson argues that Respondents have improperly used hindsight in combining the prior art references. (CRB 

at 25-26.) The Court agrees. The relaxation data relied upon by Respondents were all collected by the applicants 

during the prosecution of the ‘616 Patent. In other words, Respondents use previously unknown data generated after 

the date of the invention to argue that such data was known prior to the invention. 

21 

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2. Secondary Considerations 

As indicated above, one of the Graham factors that must be considered in an obviousness 

analysis, is “objective evidence of nonobviousness,” also called “secondary considerations.” See 

Stratoflex, Inc. v. Aeroquip Corp., 71 3 F.2d 1530, 1536 (Fed. Cir. 1983) (“Thus evidence arising 

out of the so-called ‘secondary considerations’ must always when present be considered en route 

to a determination of obviousness.”). However, secondary considerations, such as commercial 

success, will not always dislodge a determination of obviousness based on analysis of the prior 

art. See KSR Int’E, 127 S.Ct. at 1745 (Commercial success did not alter conclusion of 

obviousness). 

Respondents argue that the evidence of commercial success of the N-DEX glove cannot 

overcome the overwhelming evidence of obviousness. (RIB at 45-46.) Respondents further 

argue that Tillotson cannot show the required nexus between N-DEX’s commercial success and 

the features of ‘616 Patent. (Id. at 45-46.) Specifically, Respondents argue that Tillotson has 

failed to show that the commercial success of the N-DEX gloves was a direct result of the 

relaxation features and that such success could be attributed to the natural rubber latex allergies 

and AIDS epidemic. (Id. at 46-47.) 

Tillotson argues that the commercial success of the N-DEX glove, the commercial 

embodiment of the ‘616 Patent, supports the validity of the ‘616 Patent. (CIB at 40.) Tillotson 

argues that there was a long felt, unsolved need for the invention and that the industry recognized 

Tillotson for fulfilling that need. (Id. at 40-41 .) Tillotson further argues that many in the glove 

industry have copied its invention and that, prior to the issuance of the ‘362 Patent, many were 

unable to create a thin nitrile glove, despite repeated efforts. (Id. at 41-42.) Tillotson further 

argues that the ‘616 Patent was and continues to be a major commercial success with Best 

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Manufacturing grossing tens of millions of dollars and cornering nearly 80% of the market. (Id. 

at 42-43.) Tillotson further argues that several manufacturers and distributors have taken 

licenses from Tillotson, while others, including Respondents, have continued to sell infringing 

gloves. (Id. at 43 .) Tillotson argues that these secondary considerations clearly demonstrate that 

the ‘616 Patent is not obvious. (Id. at 44.) 

Staff argues that the long felt need for the invention claimed in the ‘6 16 Patent and the 

significant commercial success are objective indicia showing non-obviousness. (SIB at 35.) 

Staff argues that the commercial success of the N-DEX glove, combined with Best Industry’s 

market share, copying by others in the industry, and industry awards and recognition all indicate 

that the ‘616 Patent was not obvious. (Id. at 35.) 

The Court Wher finds that secondary considerations weigh heavily against a finding of 

obviousness. Tillotson fulfilled a long felt but unsolved need by creating a closely fitting glove 

that allowed for dexterity without applying excessive pressure to the hand. (CX-838C at Q&A 

30-54,60,62,66 (Tanger Rebuttal); CX-839C Q&A 6-7 (Moalli Rebuttal).) Tillotson achieved 

great commercial success with its N-DEX glove, which embodied the glove disclosed in the ‘616 

Patent, receiving industry recognition and awards (CX-787C at Q&A 43,70 (Tanger Direct); 

CX-837 at Q&A 62,85B, 105,125 (Tillotson Rebuttal); CX-841C; CX-842C; CX-848C; CX849C; CX-895-897C) and generating tens of millions in sales and capturing more than 80% of 

the non-vinyl synthetic examination glove market. (CX-838C at Q&A 52-53 (Tanger Rebuttal); 

CX-821C at TLC038438-441; CX-824C at TLC104783; CX-837C at Q&A 47 (Tillotson 

Rebuttal).). This commercial success is related to the improved comfort and dexterity of the NDEX glove compared to traditional natural rubber gloves. (CX-838C at Q&A 36-40,48 (Tanger 

Rebuttal); Tillotson Tr. 1253:5-15; Tanger Tr., 136O:lO-1363:17; CX-822C; CX-846C.) 

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Tillotson also currently continues its success by licensing the ‘61 6 Patent, which generated 

nearly $5 million in revenue in 2006 and 2007, respectively. (CX-838C Q&A 63-70 (Tanger 

RebuttaI).) Thus, the Court finds that the forgoing considerations evidence non-obviousness of 

the ‘6 16 Patent. 

Therefore, the Court finds that Respondents have failed to meet their burden of showing 

by clear and convincing evidence that the asserted claims of the ‘61 6 Patent are invalid for 

obviousness. 

F. BestMode 

Section 112,l 1 of Title 35 of the United States Code sets out the best mode requirement, 

stating in relevant part that “[tlhe specification shall contain . . . and shall set forth the best mode 

contemplated by the inventor of carrying out the invention.” 35 U.S.C. tj 112 7 1. The Court of 

Appeals for the Federal Circuit has held that “[tlhe purpose of the best mode requirement is to 

ensure that the public, in exchange for the rights given the inventor under the patent laws, obtains 

from the inventor a full disclosure of the preferred embodiment of the invention.” Dana Corp. v. 

IPC Ltd. Partnership, 860 F.2d 41 5,418 (Fed. Cir. 1988), cert. denied, 490 U.S. 1067 (1 989). 

The determination of whether the best mode requirement is satisfied is a question of fact, which 

must be proven by clear and convincing evidence. Transco Products Inc. v. Performance 

Contracting, Inc., 38 F.3d 551, 559-60 (Fed. Cir. 1994). 

In determining compliance with the best mode requirement, two inquires are undertaken. 

The first inquiry is whether, at the time of filing the patent application, the inventor possessed a 

best mode of practicing the invention. Eli Lilly and Co. v. Barr Laboratories, Inc., 25 1 F.3d 955, 

963 (Fed. Cir. 2001); see also Liquid Dynamics Corp. v. Vaughan Co., Inc., 449 F.3d 1209, 1223 

(Fed.Cir. 2006); Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1535 (Fed. Cir. 1987) 

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(The specificity of disclosure necessary to meet the best mode requirement is determined “by the 

knowledge of facts within the possession of the inventor at the time of filing of the application.”). 

This first inquiry is subjective and focuses on the inventor’s state of mind at the time the patent 

application was filed. Eli Lilly, 251 F.3d at 963. The second inquiry is, if the inventor did 

possess the best mode, whether the inventor’s disclosure is adequate to enable one of ordinary 

skill in the art to practice the best mode of the invention. Id. This second inquiry is objective 

and depends on the scope of the claimed invention and the level of skill in the relevant art. Id. 

The “contours of the best mode requirement are defined by the scope of the “claimed 

invention” and thus, the first task in any best mode analysis is to define the invention. Northern 

Telecom Ltd. v. Samsung Electronics Co., Ltd., 215 F.3d 1281, 1286-87 (Fed. Cir. 2000). “The 

definition of the invention, like the interpretation of the patent claims, is a legal exercise, wherein 

the ordinary principles of claim construction apply.” Id. Once the invention is defined, the best 

mode inquiry moves to determining whether a best mode of carrying out that invention was held 

by the inventor. If so, that best mode must be disclosed. In P’zer, Inc. v. Teva Pharmaceuticals 

USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), the Federal Circuit summarized its best mode 

jurisprudence as follows: 

We held that the best mode requirement does demand disclosure of an inventor’s 

preferred embodiment of the claimed invention. However, it is not limited to that. 

We have recognized that best mode requires inventors to disclose aspects of making 

or using the claimed invention [when] the undisclosed matter materially affects the 

properties of the claimed invention. 

P’zer, 5 18 F.3d at 1364 (internal quotations and citations omitted). 

Respondents argue that the ‘616 Patent is invalid for failure to disclose the best as 

required under 35 U.S.C. 5 112,T 1. (RIB at 48.) Specifically, Respondents argue that the 

inventors failed to disclose their preferred mode for practicing the claimed invention, namely the 

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use of Reichhold 68073 as the nitrile butadiene rubber. (Id. at 48-49.) Respondents argue that 

the inventors failed to disclose their preference of using Reichhold 68073, even though Mr. 

DeBecker considered it one of the components that made their invention unique. (Id. at 50-52.) 

Respondents further argue that the inventors failed to disclose the fact that they considered 

Reichhold 68074 to be an inferior rubber for their claimed invention and that the inventors’ 

laboratory notebook confirmed their preference for Reichhold 68073. (Id. at 52-55.) 

Respondents argue that Tillotson concealed its best mode, noting that “Example 1 Latex 

Formulation” contained trade names for some of the “relatively minor’’ ingredients yet failed to 

identifj Reichhold 68073 as the preferred nitrile butadiene rubber. (Id. at 55-56.) Respondents 

argue that the inventors specifically deleted the trade name for their preferred nitrile butadiene 

rubber even though the inventors considered it to be the most critical aspect of their invention. 

(Id. at 56.) 

Respondents further argue that Tillotson’s legal arguments incorrectly state the law: (1) 

Tillotson incorrectly focuses on the superiority of Reichhold 68073 when the focus should be on 

the inventor’s subject belief at the time of the application is controlling; (2) Tillotson 

incorrectly focuses on whether the inventors deliberately concealed Reichhold 68073 when 

deliberate concealment is not an element of best mode defense; (3) Tillotson incorrectly argues 

that nitrile rubber latex was not claimed when the best mode need only relate to an aspect recited 

in the claims but need not be the entire claimed invention; (4) the commercial availability of 

Reichhold 68073 does not absolve Tillotson of the obligation to disclose its best mode; (5) 

Tillotson confuses the best mode requirement with the enablement requirement; and (6) 

Tillotson’s argument that its selection of Reichhold 68073 was merely a “production detail” is 

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not enough to meet its best mode requirement because Tillotson is required to disclose any 

specific techniques recognized at the time of filing. (Id. at 58-60.) 

Tillotson argues that Mr. DeBecker testified that he did not believe that the particular 

latex made the N-DEX glove different from earlier gloves and that he and Mr. Tillotson believed 

that they could get “good relaxation” from other types of latex as well. (CIB at 52.) Tillotson 

further argues that the decision to use Reichhold 68073 was based on reasons other than the 

relaxation properties of latex, namely production details and commercial and manufacturing 

considerations. (Id. at 52-53.) Tillotson further argues that there is no evidence that Reichhold 

68073 was any better than other nitrile lattices and that one of ordinary skill in the art would 

realize that other brands of nitrile latex could be used. (Id at 53.) Tillotson further argues that it 

continued to experiment with different nitrile lattices even after the ‘362 Patent and the ‘616 

Patent had been issued. (Id. at 53.) Tillotson further argues that there is no evidence of 

“deliberate concealment” because, as Mr. DeBecker testified, the “patentable” portion of the 

invention was that it was a nitrile glove and that all other ingredients of the N-DEX formula were 

relatively minor. (Id. at 53.) 

Staff agrees and argues that Respondents have failed to show by clear and convincing 

evidence that Mr. DeBecker and Mr. Tillotson failed to disclose the best mode. (SIB at 23-24.) 

Staff argues that the ‘61 6 Patent does not claim nitrile rubber latex or a manner of making such 

latex; that the specification identifies carboxylated nitrile butadiene rubber as one of the starting 

materials in producing the glove; and that the inventors’ failure to list the particular brand of 

nitrile butadiene rubber does not rise to a best mode violation. (Id. at 23.) Staff argues that the 

inventors’ decision to use a particular brand of latex was a commercial consideration and, as 

such, was not required to be disclosed under the best mode requirement. (Id. at 24.) 

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Staff further argues that the disclosure a production or routine detail, such as a particular 

brand of commercially available nitrile latex is not required since it would be readily apparent to 

one of ordinary skill in the art. (Id. at 23.) Staff further argues that Mr. DeBecker explained his 

reasons as to why he chose Reichhold 68073, namely the large quantities of that latex at the plant, 

which Staff argues is a commercial consideration not related to the quality or nature of the 

invention. (Id. at 24.) Staff further argues that since the inventors disclosed nitrile butadiene 

rubber and one of ordinary skill in the art would be able to choose any brand of commercially 

available latex, then the disclosure of a specific brand is merely routine detail. (Id. at 24.) 

The Court finds that Respondents have failed to show by clear and convincing evidence 

that the inventors, Mr. DeBecker and Mr. Tillotson, failed to disclose their best mode for 

practicing the claimed invention. Respondents argue that Mr. DeBecker’s statement that “We 

felt we could get a better glove with [Reichhold 680173” and his lab notebook, which 

Respondents argue shows a clear preference for Reichhold 68073, is evidence that the inventors 

preferred Reichhold 68073 and that their failure to disclose this preference violates the best mode 

requirement. The Court disagrees. First, the evidence shows that Mr. DeBecker did not consider 

Reichhold 68073 the “best” latex and that he believed that he could get “good relaxation with 

other latexes as well.” (DeBecker, Tr. 702: 16-17.) Second, Mr. DeBecker specifically stated 

that the decision to use Reichhold 68073 was based on reasons other than those related to the 

relaxation properties of that latex: 

Q. Yet somehow between the time your laboratory notebook was written and 

the time this ‘362 application was filed, the key element, the latex designation, 

68073, was deleted, other trade names were maintained and other trade names 

were actually added to the recipe that you disclose in example 1, correct? 

A. I don’t know deleted. It is not there. 

Q. Okay. 

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A. At the time we knew that we could get good relaxation with other latexes. I 

think it shows in my lab book we could get good relaxation with a 68074 also. So 

we realized that what we needed was a carboxylated nitrile butadiene latex, not 

that we necessarily needed the specific 68073 latex. 

Q. You didn’t need it, but it was the best one you found, wasn’t it? 

A. Not for relaxation specifically. 

Q. But for your glove, it was the best one, wasn’t it? 

A. But for other reasons. The patent is about relaxation. 

(DeBecker, Tr. 702:6-703:4.) Mr. DeBecker testified that the other reasons for preferring 

Reichhold 68073 included its ready availability at the plant since it was being used to 

manufacture other gloves and since there were already appropriate storage tanks for large 

quantities of it. (DeBecker, Tr. 85 1 : 17-25.) Mr. DeBecker further testified that to introduce “a 

different raw material” would require addition storage tanks and that the decision to use 

Reichhold 68073 was because “it was really simpler to use that which we already had on hand.” 

(DeBecker, Tr. 85 1:7-852:5.) Thus, the evidence does not show clearly and convincingly that 

Mr. DeBecker preferred Reichhold 68073 because it was better than any other latex. Rather, the 

evidence shows that decision to test and use Reichhold 68073 was based on a production detail, 

i. e., what Tillotson already had available in large quantities. 

Even assuming that Mr. DeBecker considered the use of Reichhold 68073 to be the best 

mode, the Court finds that the evidence does not clearly and convincingly show that the written 

description failed to disclose the best mode such that one of ordinary skill could not practice it. 

The claimed invention is directed to “a closely fitting glove Comprising a layer elastomeric 

material (a) comprising nitrile butadiene rubber.” (JX-3 at 6:33-34 (‘61 6 Patent).) The claimed 

invention is not directed to a specific brand of nitrile rubber or even the production of nitrile 

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rubber such that absent the preferred brand of latex, one could not practice the claimed invention. 

Moreover, the ‘6 16 Patent specification further lays out a specific formula for one of ordinary 

skill in the art to practice the invention and lists carboxylated nitrile butadiene rubber as its first 

ingredient. (‘616 Patent, 5:35-45.) 

The fact that Mr. DeBecker and Mr. Tillotson had a preferred brand of commercially 

available nitrile butadiene rubber, Reichhold 68073, which was not disclosed in the ‘616 Patent, 

does not rise to a best mode violation. Rather, “the best mode requirement does not extend to 

production details or routine details.” Eli Lilly, 251 F.3d at 963. The Federal Circuit explained: 

However, the best mode requirement does not require an inventor to disclose 

production details so long as the means to carry out the invention are disclosed. 

This includes providing supplier/trade name information where it is not needed, 

i.e., where such information would be “mere surplusage -- an addition to the 

generic description.” Such supplier/trade name information must be provided only 

when a skilled artisan could not practice the best mode of the claimed invention 

absent this information. 

Transco Prods. v. Performance Contracting, 38 F.3d 551,560 (Fed. Cir. 1994) (internal 

citations omitted). Here, there is no evidence that one of ordinary skill in the art could 

not practice the invention based absent the disclosure of the use of Reichhold 68073. 

Therefore, the Court finds that the ‘616 Patent is not invalid for failure to disclose 

best mode. 

G. Enablernent 

Section 112, fl 1 of Title 35 requires that the specification describe the manner and 

process of making and using the invention “in such full, clear, concise, and exact terms as to 

enable any person skilled in the art to which it pertains, or with which it is most nearly connected, 

to make and use the same.” 

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The issue of whether a disclosure is enabling is a matter of law. Applied Materials, Inc. v. 

Advanced Semiconductor Materials America, Inc., 98 F.3d 1563, 1575 (Fed. Cir. 1996). “To be 

enabling, the specification of a patent must teach those skilled in the art how to make and use the 

full scope of the claimed invention without ‘undue experimentation.’” Genentech, Inc. v. Novo 

Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997). “Patent protection is granted in return for an 

enabling disclosure of an invention, not for vague, intimations of general ideas that may or may 

not be workable.” Id. at 1366. Although a specification need not disclose minor details that are 

well known in the art, “[ilt is the specification, not the knowledge of one skilled in the art, that 

must supply the novel aspects of an invention in order to constitute adequate enablement,” and in 

so doing the specification cannot merely provide “only a starting point, a direction for further 

research.” Id. On the other hand, ‘‘Lilt is not fatal if some experimentation is needed, for the 

patent document is not intended to be a production specification.” Northern Telecom, Inc. v. 

Datapoint Corp., 908 F.2d 93 1,941 (Fed. Cir. 1990). “Undue experimentation” is “a matter of 

degree” and “not merely quantitative, since a considerable amount of experimentation is 

permissible, if it is merely routine, or if the specification in question provides a reasonable 

amount of guidance with respect to the direction in which the experimentation should 

proceed ....” PPG Industries, Inc. v. Guardian Industries Corp., 75 F.3d 1558, 1564 (Fed. Cir. 

1996). 

It is well-settled that in order to be enabling under Section 112, “the patent must contain a 

description sufficient to enable one skilled in the art to make and use the full scope of the 

claimed invention.” United States v. Teletronics, Inc., 857 F.2d 778,785 (Fed. Cir. 1988); see 

also Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd, 927 F.2d 1200, 1213 (Fed. Cir. 1991) 

(inventor’s disclosure must be “sufficient to enable one skilled in the art to carry out the 

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invention comensurate with the scope of his claims”). Section 112 requires that the scope of 

the claims must bear a reasonable correlation to the scope of enablement provided by the 

specification to such persons. Application ofFischer, 427 F.2d 833,839 (C.C.P.A. 1970). 

Respondents argue that the specification of the ‘616 Patent does not enable the full scope 

of the claims. (RIB at 62.) Specifically, Respondents argue that the specification fails to specify 

whether the nitrile butadiene rubber (“NBR’) is carboxylated or non-carboxylated and the ‘6 16 

claims can encompass both possibilities. (Id. at 62.) Respondents’ expert, Dr. Mills, concluded 

that while some carboxylated NBR gloves could be made, it would take a substantial amount of 

experimentation to make non-carboxylated NBR gloves due to the large number of candidate 

materials and parameters. (Id. at 63.) Dr. Mills further testified that the limited information and 

failure to disclose a working embodiment of a non-carboxylated NBR glove in the ‘6 16 Patent 

would cause undue experimentation. (Id. at 63-64.) Respondents further argue that if one of the 

inventors, Mr. DeBecker, could not make embodiments within the scope of the claims without 

undue experimentation, then clearly one of ordinary skill in the art also could not. (Id. at 64-65.) 

Tillotson argues that Respondents have failed to meet their burden of showing by clear 

and convincing evidence that the asserted claims fail to satisfy the enablement requirement. 

(CIB at 46-47.) Tillotson argues that Respondents proffer only conclusory statements from Dr. 

Mills and that Dr. Mills only testified that it would take a substantial amount of experimentation 

and not “undue” experimentation to produce a non-carboxylated NBR glove. (Id. at 47.) 

Tillotson argues that one of ordinary skill in the art could create a non-carboxylated NBR glove 

without undue experimentation because the composition of both carboxylated and noncarboxylated NBR are similar; because they are compounded in the same manner to produce 

articles; and because the mechanical properties of both are affected in a similar manner. (Id. at 

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47-48.) Tillotson further argues that Mr. DeBecker and Dr. Moalli testified that while neither 

had made a non-carboxylated NBR glove, that it was possible to create one with the properties 

claimed in the ‘616 Patent. (Id. at 48.) Tillotson further argues that one of ordinary skill in the 

art could create a non-carboxylated NBR glove based on the teachings of the ‘616 Patent without 

undue experimentation because of the information available on non-carboxylated NBR in 1990. 

(Id. at 48-49.) Staff agrees and argues that Respondents have failed to meet their burden for the 

same reasons argued by Tillotson above. (SIB at 25-27.) 

The Court finds that Respondents have failed to show by clear and convincing evidence 

that the ‘616 Patent fails to meet the enablement requirement. First, Dr. Mills testified that it 

would only take “substantial experimentation” to produce a non-carboxylated NBR glove, but 

did not testify that it would require “undue experimentation.” (RX-162C at Q&A 135 (Mills 

Direct).) Undue experimentation is required for a patent to fail the enablement requirement. See 

Genentech, 108 F.3d at 1365; Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 

1384 (Fed.Cir. 1986) (enablement “is not precluded even if some experimentation is necessary, 

although the mount of experimentation needed must not be unduly extensive”); Wands, 858 

F.2d at 737 (“a considerable amount of experimentation is permissible, if it is merely routine, or 

if the specification in question provides a reasonable amount of guidance with respect to the 

direction in which the experimentation should proceed”). Dr. Mills further testified that there 

was information in 1990 regarding the use of non-carboxylated NBR in the thin film. (Id. at 

Q&A 137.) The evidence further shows that: (1) both carboxylated and non-carboxylated NBR 

contain essentially the same constituents (butadiene and acrylonitrile) with carboxylated NBR 

having an acid group for additional cross-linking; (2) there was some knowledge in the art as to 

the effect of non-carboxylated NBR on relaxation; (3) when formulating products, both non99 
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carboxylated and carboxylated NBR are typically combined with the same materials such as 

sulfur; and (4) the mechanical properties of both are affected to a similar degree by the various 

links and sulfur cross-links (which affect mechanical properties including tensile strength and 

stress relaxation), as well as by the length and structure of the individual polymer chains. 

(Moalli, Tr. 1465:9-1466:ll; 1469:20-24; CX-839C at Q&A 8-24 (Moalli Rebuttal); RX- 162C 

at Q&A 34, 117, 137 (Mills Direct).). 

The evidence Wher shows that information relating to changes in the chemistry and 

processing of both carboxylated and non-carboxylated NBR that led to increased tensile strength 

would also reduce relaxation was readily available, thereby allowing persons of skill in the art 

obtain the desired relaxation for a given non-carboxylated NBR glove in view of such 

information. (CX-839C at Q&A 16-1 7,22-23 (Moalli Rebuttal).) The evidence fbrther shows 

that it would be possible to formulate a glove meeting the limitations of claim 1 using noncarboxylated NBR as well as carboxylated NBR. (Moalli, Tr. 1465:l-18; DeBecker, Tr. 8545- 

16.) 

Therefore, the Court finds that Respondents have failed to meet their burden of showing 

by clear and convincing evidence that the ‘6 16 Patent fails to meet the enablement requirement. 

H. Definiteness 

Respondents did not address definiteness in its invalidity section in its post-hearing brief, 

and Respondents have waived any arguments with regard to this affirmative defense. 

Respondents extensively briefed this issue in their combined pre-hearing brief and presented 

expert testimony at the hearing. (See Respondents Combined Pre-hearing Brief at 13 1 - 137; 1 see 

also RX-162C (Mills Direct) and RX-324 (Begley Direct); see generdy Mills, Tr. 863- Begley, 

Tr. 11 15-1 124 .) However, Respondents did not address definiteness at all in its initial post100 
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hearing brief. (See generally RIB at 48-67.) Therefore, pursuant to Ground Rule 1 1.1, 

Respondents have waived any arguments relating to indefiniteness. 

VI. UNENFORCEABILITY 

A. Applicable Law 

A patent is unenforceable on grounds of “inequitable conduct” if the patentee withheld 

material information from the PTO with intent to mislead or deceive the PTO into allowing the 

claims. LaBounty Mfi., Inc. v. US. Int’l Trade Comm’n, 958 F.2d 1066, 1070-1074 (Fed. Cir. 

1992). Both materiality and intent must be proven by clear and convincing evidence. Id.; 

Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 872 (Fed. Cir. 1988), cert. 

denied, 490 U.S. 1067 (1 989); Certain Salinomycin Biomass and Preparations Containing Same, 

Inv. No. 337-TA-370, Unreviewed Initial Determination at 76, 1995 WL 1049822 (U.S.I.T.C. 

November 6,1995), afd sub nom. Kaken Pharmaceutical Co., Ltd. v. US. Int ’I Trade Comm ’n, 

1 1 1 F.3d 143 (Fed. Cir. 1997) (Table) (nonprecedential) (“Salinomycin”). When inequitable 

conduct occurs in relation to one or more claims of a patent, the entire patent is unenforceable. 

Kingsdown, 863 F.2d at 874. 

According to the rules of the PTO, the duty to disclose information “exists with respect to 

each pending claim until the claim is canceled or withdrawn from consideration, or the 

application becomes abandoned. Information material to the patentability of a claim that is 

canceled or withdrawn from consideration need not be submitted if the information is not 

material to the patentability of any claim remaining under consideration in the application. There 

is no duty to submit information which is not material to the patentability of any existing claim.” 

37 C.F.R. 0 1.56(a). 

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Generally, when withheld information is highly material, a lower showing of deceptive 

intent will be sufficient to establish inequitable conduct. American Hoist & Derrick Co. v. Sowa 

& Sons, Inc., 725 F.2d 1350, 1363 (Fed. Cir.), cert. denied, 469 U.S. 821 (1984). Moreover, 

“[dlirect proof of wrongful intent is rarely available but may be inferred from clear and 

convincing evidence of the surrounding circumstances.” LaBounty, 958 F.2d at 1076; 

Salinomycin, ID at 77. The conduct at issue must be viewed in light of all the evidence, 

including evidence of good faith. Kingsdown, 863 F.2d at 876; Salinomycin, ID at 77. 

“Information is material where there is a substantial likelihood that a reasonable examiner 

would consider it important in deciding whether to allow the application to issue as a patent.” 

LaBounty, 958 F.2d at 1074; Salinomycin, ID at 77. A patent applicant, however, has no 

obligation to disclose a reference that is cumulative or less pertinent than those already before 

the examiner. Halliburton Co. v. Schlumberger Tech. Corp., 925 F.2d 1435, 1439-40 (Fed. Cir. 

1991). Under the rules of the PTO, information is material when it is not cumulative to 

information of record and it either (i) “establishes, by itself or in combination with other 

information, a prima facie case of unpatentability of a claim”; or (ii) “it refutes, or is inconsistent 

with, a position the applicant takes” in either opposing the PTO’s argument of unpatentability or 

asserting the applicant’s own argument of patentability. 37 C.F.R. 0 1.56(b). Close cases, 

however, “should be resolved by disclosure, not unilaterally by applicant.” Abbott Laboratories 

v. TorPharm, Inc., 300 F.3d 1367,1379 (Fed. Cir. 2002) quoting LaBounty, 958 F.2d at 1076. 

Respondents argue that the asserted claims of the ‘61 6 Patent are unenforceable by 

reason of inequitable conduct for three reasons. First, Mr. Tillotson submitted a false reissue 

declaration to the PTO during the prosecution of the ‘616 Patent. (RIB at 24.) The second 

reason is the failure to disclose the unreliability of the Scott Tester data upon which the inventors 

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relied upon to support the reissue of Claim 23. (Id. at 28.) The third reason is the failure to 

disclose that the Q-Test was used instead of the Scott Tester to obtain the test results to 

overcome prior art. (Id at 32.) 

B. Reissue Declaration 

Respondents argue that “Tillotson could only avoid a finding that the failure to originally 

disclose the prior art DERMA-THINTM and SOLVEX 8 gloves was with deceptive intent by 

further deceptive intent - representing to the PTO that it had not been aware of those gloves until 

after the original ‘362 patent issued. It willfully did just that.” (RIB at 25.) Respondents argue 

that the patent examiner relied on these false statements that the inventors were unaware of the 

DERMA-THINTM and SOLVEX 8 gloves and that such reliance is evidenced by the fact that 

the ‘616 Patent issued. (Id at 25-26.) Respondents argue that the evidence shows that the 

inventors were aware of the prior art gloves and that Tillotson has not and cannot present any 

evidence to the contrary. (Id. at 27.) Respondents argue that the intentional misrepresentation 

of the inventors’ alleged ignorance of the DERMA-THINTM and SOLVEX 8 gloves clearly 

constitutes inequitable conduct rendering the ‘61 6 Patent invalid. (Id. at 27-28.) 

Tillotson argues that the Reissue Declaration did not contain any false statements and that 

Respondents have failed to meet their burden of showing by clear and convincing evidence that 

such statement was material or that it was made with intent to deceive the PTO. (CIB at 83.) 

Tillotson argues that the Reissue Declaration and the Supplemental Reissue Declaration further 

state that the inventors were not aware of the elastic properties of the DERMA-THINTM and 

SOLVEX 8 gloves and that the PTO was well aware of the fact that the DERMA-THINTM 

gloves were manufactured by Tillotson’s wholly owned subsidiary. (Id. at 84.) Tillotson further 

argues that Respondents failed to present evidence that the inventors were aware of the SOLVEX 

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PUBLIC VERSION 

@ glove or its relaxation properties prior to 1993 or that Mr. Tillotson, the declarant on the 

Reissue and Supplemental Reissue Declaration, was aware of the relaxation properties of the 

DERMA-THINTM glove. (Id. at 85.) Tillotson further argues that, even assuming that the 

statements were false, Respondents have failed to show that the statements were considered 

material to patentability. (Id. at 85.) Tillotson further argues that Respondents have failed to 

show that the statements were made with an intent to deceive the PTO. (Id. at 85-86.) 

Staff argues that, while it is a close call, the evidence does establish that the inventors 

acted with intent to deceive the PTO. (SIB at 48-49.) Staff acknowledges that while the 

statements are material, there is evidence that shows that there was no intent to deceive the PTO 

with the false statements. (Id. at 49.) Specifically, Staff argues that Mr. DeBecker’s limited role 

in the actual reissue application process, outside of providing test data, evidences a material 

mistake which does not rise to an actual intent to deceive the PTO. (Id. at 49-50.) 

The Court finds that Respondents have failed to show by clear and convincing evidence 

that the inventors acted with intent to deceived the PTO. As an initial matter, the Court finds that 

the inventors’ knowledge of the DERMA-THINTM and SOLVEX @ gloves prior to 1993 is 

material. More than just knowing of the gloves existence, the inventors would have to realize 

that the property of the gloves made them relevant to the invention. The DERMA-THINTM 

glove was a natural latex glove, the SOLVEX (33 was a thick industrial glove. While the inventors 

may have known the two existed, they did not realize they could be relevant to the invention. 

These gloves form the basis for reissue application and are listed in the Information Disclosure 

Statement of the reissue application. (JX-4 at TLC000184B-G and at TLC00059-61 (‘616 

Prosecution History).) Specifically, the Court finds that it was not merely the inventors’ 

knowledge of the existence of the gloves that is material, but whether the inventors realized that 

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the properties of these gloves made them relevant to the invention claimed in the ‘616 Patent. 

Therefore, the inventors’ knowledge of the properties of these prior art gloves is highly material 

to the ‘616 Patent. 

The Court finds, however, that the evidence fails to establish by clear and convincing 

evidence that the inventors intended to deceive the PTO. First, statements within the 

Supplemental Reissue Declaration and Reissue Declaration weigh against finding an intent to 

deceive. Respondents argue that Mr. Tillotson’s statement that neither he nor Mr. Pappas were 

aware of the prior art in the information disclosure statement prior to the issuance of the ‘362 

Patent is plainly false and that Mr. Tillotson lied about his knowledge in order to deceive the 

PTO in order to obtain the reissue patent. (RIB at 24-28.) The Court notes, however, that Mr. 

Tillotson further explained in the declaration that “[nleither Applicant nor his attorney were 

aware of the elastic properties of the SOLVEX 8 or DERMA-THINTM glove prior to 1993 .” 

(JX-4 at TLCOOOl84F (‘616 Prosecution History) (emphasis added).) Such a clarification 

evidences a good faith effort on the inventors’ part to explain their position, i. e., what they did 

not know, to the examiner and the PTO and provide more complete and full disclosure. In 

addition, the inventors conducted extensive testing of the prior art samples, indeed they went 

through great efforts to recreate certain samples, in an effort to disclose the properties of these 

gloves. (CX-836C at Q&A 291-293 (DeBecker Rebuttal); DeBecker Tr., at 694:16-695:2.) This 

further evidences good faith on the part of the inventors during the reissue application process. 

The conduct at issue must be viewed in light of all the evidence, including evidence of good faith. 

Kingsdown, 863 F.2d at 876; Salinomycin, ID at 77. 

In addition, the Court had the opportunity to take testimony fi-om one of the inventors, Mr. 

DeBecker, and found him to be an extremely credible and honest witness. Mr. DeBecker 

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testified that he knew about the SOLVEX 8 or DERMA-THINTM gloves. (DeBecker, Tr. 

779:23-780:6.) Mr. DeBecker further testified, however, that he had a limited role in the reissue 

prosecution and did not recall having a role in preparing any declaration. (CX-786C at Q&A 54- 

59 (Moalli Direct); DeBecker, Tr. 767:4-14; 770: 14-771 :4; 776: 10-20.) Mr. DeBecker further 

testified that he did not review the reissue declaration and did not see the statement about not 

knowing about the relaxation properties of the prior art gloves. (DeBecker Tr., 783:15-20.) 

While Mr. DeBecker acknowledged receiving information about the reissue application and the 

process, he candidly admits that he probably did not read the “legal stuff.’’ (DeBecker Tr., 

772:6-25.) Quite simply, it appears that Mr. DeBecker chose to focus on his job, which was to 

create the samples and test them, and neglected to follow Mr. Pappas’s instructions to carefully 

read over the “legal stuff’ and the reissue declaration. Such neglect, however, does not appear to 

be based on a purposeful decision to ignore Mr. Pappas’s instructions so much as the fact that, 

based on Mr. DeBecker’s testimony and demeanor at the hearing, Mr. DeBecker was focused on 

the task assigned to him - namely to test the prior art samples. 

Moreover, there is no clear and convincing evidence that Mr. Tillotson, the declarant in 

the reissue declaration, knew of the SOLVEX @ glove prior to 1 993?2 Respondents’ main 

argument appears to be that Mr. Tillotson should have known about this glove (DeBecker Tr., 

780: 12-782:4.) and that should suffice for the Court infer that Mr. Tillotson did know and that he 

purposefully lied about knowing, without having to identify “specific evidence.” (RRB at 15-1 6.) 

While Respondents are correct in that intent to deceive is often “proven by the acts, the natural 

consequences of which are presumed intended by the actor,” the Federal Circuit has also stated 

that “the involved conduct viewed in light of all the evidence, including evidence indicative of 

** Mr. DeBecker stated that he did not discuss the test results of relaxation properties of the DERMA-THINTM 

gloves that he obtained in 1990 with Mr. Tillotson because, at the time, Mr. DeBecker did not consider that glove to 

be pertinent to the ‘362 Patent. (CX-836C at Q&A 263-266 (DeBecker Rebuttal).) 

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good faith, must indicate sufficient culpability to require a finding of intent to deceive.” 

Kingsdown, 863 F.2d at 876. Therefore, given the totality of circumstances, the Court finds that 

Respondents have failed to meet their burden of showing by clear and convincing evidence that 

the reissue declaration was submitted with an intent to deceive. 

C. Scott Tester Data 

Respondents argue that the inventors were aware that the Scott Tester was unreliable, 

particularly at low stress levels. (RIB at 28.) Respondents argue that the inventors knew that the 

Scott Tester and Q-Tester machine differed by 44 percentage points; that as the pressure 

approached zero, the Scott Tester became unreliable; 23 that the inventors still submitted 

unreliable Scott Tester data to the PTO; and that the inventors withheld the known unreliability 

of the Scott Tester data from the PTO. (Id. at 28-29.) 

Respondents argue that the unreliability of the Scott data was highly material and that 

such information should have been disclosed to the PTO because the PTO relied on the data 

generated by the Scott Tester in granting claim 23. (Id. at 30.) Respondents argue that Mr. 

Tillotson purposely withheld this information and that Mr. Tillotson’s failure to disclose this 

information to his patent attorney where he knew, or should have known, that the information 

would be material implied intent to deceive the PTO. (RIB at 30.) Respondents further argue 

that this failure to disclose information regarding the unreliability of the Scott Tester to Mr. 

Tillotson’s own patent attorney, Mr. Pappas, coupled with the high materiality of the information, 

creates a strong inference of intent to deceive. (Id. at 30-3 1 .) Respondents argue that this is 

clear evidence of inequitable conduct on the part of Mr. Tillotson and renders the claims of the 

‘616 Patent invalid. 

Claim 23 claims “[a] glove as in claim 1, wherein the layer of elastomeric material is further characterized 

having elastomeric properties such that said reduced pressure is about zero.” (JX-3 at 8:25-28 (‘61 6 Patent).) 

23 

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PUBLIC VERSION 

Tillotson argues that Respondents have‘ failed to show by clear and convincing evidence 

that the prosecution of Claim 23 was inequitable because of the inventors’ reliance on the data 

generated by the Scott Tester. (CIB at 86-87.) Tillotson argues that the evidence shows that the 

data generated by the Scott Tester and submitted to the PTO was accurate and that Mr. Tillotson 

reasonably believed and relied on this fact without intent to deceive. (Id. at 86-87.) Tillotson 

argues that the evidence shows that the Scott Tester was an accurate testing device, despite the 

fact that it sometimes produced variable results. (Id. at 87.) Tillotson further argues that Mr. 

Tillotson’s preference for the Scott Tester was based on his own repeated use of the throughout 

the course of his working life. (Id. at 87-88.) As noted below, Mr. DeBecker confirmed this and 

testified that Mr. Tillotson preferred the Scott Tester and believed it to be reliable. 

Staff argues that the evidence is far from clear and convincing to establish inequitable 

conduct. (SIB at 50.) Staff argues that, even assuming that such information was material, the 

evidence only shows that one inventor, Mr. Tillotson, preferred the Scott Tester while the other 

inventor, Mr. DeBecker, preferred the Q-tester. (Id. at 50.) Staff further argues that Mr 

DeBecker did not think the Scott Tester was per se unreliable, but that he questioned the results 

of the Scott Tester at low pressure levels given his own experience and belief with the N-DEX 

gloves, which he felt relaxed to zero pressure. Staff further argues that Dr. Moalli testified that 

his own tests on the N-DEX gloves using the Instron machine yielded similar results to those 

reported in the Scott Tester and that the use of different machines to measure the properties set 

forth in the ‘616 Patent is contemplated in the ASTM D-412 standard. (Id. at 50-51 .) The use of 

different machines will still yield similar results, assuming that the machines are properly 

calibrated and the tests are done in a similar manner. (Id. at 5 1 .) 

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The Court finds that Respondents have failed to meet their burden of proving by clear 

and convincing evidence that the inventors committed inequitable conduct. First, the parties 

dispute whether the examiner found the test data generated by the Scott Tester to be material in 

granting claim 23 ?4 (RIB at 28-29; CRB at 2 1 ; RRB at 17- 18.) The Court finds that 

Respondents have failed to show that the reliability of the Scott Tester was material. Rather, 

Respondents simply make the statement that Tillotson’s attorney, Mr. Pappas, would have found 

the information regarding the unreliability of the Scott Tester data “important to the PTO” and 

that “but for the withholding of this information, Claim 23 of the ‘61 6 reissue Patent would not 

have been allowed.” (RIB at 30.) Respondents point to nothing in the prosecution history, 

however, evidencing that the examiner relied on any inaccurate data generated by the Scott 

Tester in granting Claim 23 of the ‘616 Patent. 

Even assuming, however, that the reliability Scott Tester data at lower pressures was 

highly material, the Court further finds that Respondents have failed to show by clear and 

convincing evidence that Mr. Tillotson’s failure to disclose this information was based on intent 

to deceive the PTO. Respondents argue that such intent is evidenced by a “standing policy” to 

report to the PTO only results that give the inventors the greatest advantage in defending their 

patent and a willingness to manipulate data that the inventors both recognized might be 

considered cheating. (RRB at 19.) The evidence shows, however, that the decision to submit the 

Scott Tester data came down to a matter of preference rather than intent to deceive. Mr. 

Tillotson preferred the Scott Tester data because of his familiarity with the machine, which he 

had used for several years, and his confidence in the results. (CX-836C at Q&A 2 17-2 1 8 

24 Respondents argue that Staff does not dispute the materiality of the Scott Tester data. However, the Court notes 

that the Staff never addresses the materiality of the data, rather the Staff specifically states that it “even assuming 

such information was material” that it did not find that Respondents had proven by clear and convincing evidence 

that there was intent to deceive the PTO. (SIB at 50.) 

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(DeBecker Rebuttal); CX-837C at Q&A 42-46 (Tillotson Rebuttal).) The evidence further 

shows that the decision not to disclose the fact that the Scott Tester produced unreliable and 

sometimes physically impossible results was based simply on the fact that the inventors truly 

believed that such results were unreliable based on their own experience, and not, as 

Respondents assert, on an intent to hide such results from the PTO. (CX-836C at Q&A 219-35 

(DeBecker Rebuttal); RX-55C.00001; DeBecker, Tr. 737:4-8,790:18-791: 12,808: 19-809: 1, 

8 10: 13-1 6.) Moreover, the evidence further shows that the N-DEX gloves, do, in fact, reach zero 

pressure and, as such, the inventors belief in such results was reasonable. (CX-836C at 228-229 

(DeBecker Rebuttal); CX-839C at Q&A at 289-91,3 17-23 (Moalli Rebuttal); Moalli Tr. 

1441 ~15-1445~9; CX-45; CX-74.) 

Therefore, the Court finds that Respondents have failed to show by clear and convincing 

evidence that the inventors conducted inequitable conduct by failing to disclose the unreliability 

of the Scott Tester at lower stress levels. 

D. Q-Test Machine 

Respondents argue that the inventors committed inequitable conduct by failing to 

disclose the fact that they used the Q-Test to obtain the test results needed to overcome 

the prior art Miller patent instead of using the Scott Tester, which the inventors used on 

their own N-DEX gloves. (RIB at 32-33.) Respondents failed to raise this basis as 

evidence of inequitable conduct in their pre-hearing brief.25 (See Respondents Combined 

Pre-hearing Brief at 157- 168.) Therefore, pursuant to Ground Rule 8(f), Respondents 

have waived any arguments relating to this inequitable conduct defense. 

Indeed, it appears that Respondents originally only intended to rely on two bases for inequitable conduct because 25 

it specifically stated in the introduction to its unenforceability arguments that “[tlhe ‘616 reissue patent is 

unenforceable by reason of Tillotson’s inequitable conduct in two independent regards.” (RIB at 22) (emphasis 

added.) 

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VII. DOMESTIC INDUSTRY 

As stated in the notice of investigation, a determination must be made as to whether an 

industry in the United States exists as required by subsection (a)(2) of section 337. Section 337 

declares unlawful the importation, the sale for importation or the sale in the United States after 

importation of articles that infringe a valid and enforceable U.S. patent only if an industry in the 

United States, relating to articles protected by the patent . . . concerned, exists or is in the process 

of being established. There is no requirement that the domestic industry be based on the same 

claim or claims alleged to be infringed. 19 U.S.C. 3 1337(a)(2). 

The domestic industry requirement consists of both an economic prong (i.e., there must 

be an industry in the United States) and a technical prong (i.e., that industry must relate to 

articles protected by the patent at issue). See Certain Ammonium Octamolybdate Isomers, Inv. 

No. 337-TA-477, Comm’n Op. at 55, USITC Pub. 3668 (Jan. 2004). The complainant bears the 

burden of proving the existence of a domestic industry. Certain Methods of Making Carbonated 

Candy Products, Inv. No. 337-TA-292, Comm’n Op. at 34-35, USITC Pub. 2390 (June 1991). 

Thus, in this investigation Tillotson must show that it satisfies both the technical and 

economic prongs of the domestic industry requirement with respect to the ‘616 Patent. As noted, 

and as explained below, it is found that these domestic industry requirements have been satisfied. 

A. Technical Analysis 

A complainant in a patent-based Section 337 investigation must also demonstrate that it 

is practicing or exploiting the patents at issue. See 19 U.S.C. tj 1337(a)(2) and (3); also see 

Certain Microsphere Adhesives, Process for Making Same, and Products Containing Same, 

Including SeEf-Stick Repositionable Notes, Inv. No. 337-TA-366, Commission Opinion at 8, 1996 

WL 1056095 (U.S.I.T.C., January 16, 1996) (“Certain Microsphere Adhesives”), afd sub nom. 
PUBLIC VERSION 

Minnesota Mining & Mfg. Co. v. US. Int‘l Trade Comm ’n, 91 F.3d 171 (Fed. Cir. 1996) (Table); 

Certain Encapsulated Circuits, Commission Opinion at 16. The complainant, however, is not 

required to show that it practices any of the claims asserted to be inffinged, as long as it can 

establish that it practices at least one claim of the asserted patent. Certain Point of Sale 

Terminals and Components Thereof, Inv. No. 337-TA-524, Order No. 40,2005 ITC LEXIS 374, 

*26 (April 1 1,2005). Fulfillment of this so-called “technical prong” of the domestic industry 

requirement is not determined by a rigid formula, but rather by the articles of commerce and the 

realities of the marketplace. Certain Diltiazem Hydrochloride and Diltiazem Preparations, Inv. 

No. 337-TA-349, U.S.I.T.C. Pub. No. 2902, Initial Determination at 138, 1995 WL 945191 

(U.S.I.T.C., February 1, 1995) (unreviewed in relevant part) (“Certain Diltiazem”); Certain 

Double-Sided Floppy Disk Drives and Components Thereof, Inv. No. 337-TA-215,227 U.S.P.Q. 

982,989 (Commission Opinion 1985) (“Certain Floppy Disk Drives”). 

The test for claim coverage for the purposes of the technical prong of the domestic 

industry requirement is the same as that for infringement. Certain Doxorubicin and 

Preparations Containing Same, Inv. No. 337-TA-300, Initial Determination at 109, 1990 WL 

710463 (U.S.I.T.C., May 21, 1990) (“Certain Doxorubicin”), aff’d, Views of the Commission at 

22 (October 3 1, 1990). “First, the claims of the patent are construed. Second, the complainant’s 

article or process is examined to determine whether it falls within the scope of the claims.” Id. 

As with infringement, the first step of claim construction is a question of law, whereas the 

second step of comparing the article to the claims is a factual determination. Markman, 52 F.3d 

at 976. The technical prong of the domestic industry can be satisfied either literally or under the 

doctrine of equivalents. Certain Excimer Laser Systems for Vision Correction Surgery and 

Components Thereof and Methods for Performing Such Surgery, Inv. No. 337-TA-419, Order 

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PUBLIC VERSION 

No. 43, 1999 ITC LEXIS 245, "7 (July 30, 1999). The patentee must establish by a 

preponderance of the evidence that the domestic product practices one or more claims of the 

patent. See Bayer, 212 F.3d at 1247. 

1. N-DEX Gloves 

Tillotson argues that its nitrile rubber gloves practice claim 1 of the '616 Patent. (CIB at 

28.) Specifically, Tillotson argues that its (1) N-DEX; (2) N-DEX Nighthawk Defender Nitrile 

Powder Free Textured Fingertips Accelerator-Free; (3) Ultimate N-DEX Free Nitrile Medical 

Examination Gloves Powder Free; (4) N-DEX Nitrile Medical Examination Gloves Powder Free; 

(5) N-DEX Free Nitrile Medical Examination Gloves Powder Free; (6) N-DEX Nitrile Glove; (7) 

Best 8 mil compound (4 mil); (8) Best Black compound (4 mil); and (9) Best NitriCare 

compound (4 mil) (collectively, the "Tillotson Gloves") practice claim 1 of the '616 Patent. (Id. 

at 28.) Dr. Moalli performed the same tests on the Tillotson Gloves that he did on respondents' 

accused gloves as set forth supra IV.B., e.g., glove fit, composition, water and water vapor 

permeability, tensile strength, thickness and puncture resistance. (CIB at 29; CX-45; CX-74; 

CPX- 173- 1 8 1 .) Dr. Moalli concluded that Tillotson's Gloves practice those claim limitations of 

claim 1 of the '616 Patent. (CIB at 29; CX-45; CX-74.) Staff also does not dispute that 

Tillotson's Gloves practice these claim limitations. (SIB at 53.) Respondents do not dispute that 

Tillotson's Gloves practice these claim limitations. (RIB at 89.) 

Respondents argue, however, that the Tillotson Gloves do not practice the relaxation 

limitation of claim 1 of the '616 Patent. (RIB at 89.) Respondents argue that the Tillotson 

GIoves fad to satisfy the relaxation limitation of claim I as set forth in Section 1V.B. 1 .a.)(5). 

(RIB at 89.) Respondents likewise argue that the Tillotson Gloves failed to meet the relaxation 

limitation under the Del Vecchio Test. (RIB at 89; supra Section 1V.B. 1 .a.)(5).) Respondents 

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PUBLIC VERSION 

state that the Tillotson Gloves do not practice claim 1 of the ‘616 Patent and that Tillotson fails 

to meet the technical prong of the domestic industry requirement. 

Staff argues that it views the 100% modulus test as the test that should be applied to 

determine if the relaxation is met. Staff argues that the results of Dr. Moalli’s 100% modulus 

test show that the Tillotson Gloves have met the relaxation limitation of claim 1. (SIB at 53.) 

For the reasons set forth above in Section 1V.B. 1 .a)(5), the Court found that the 100% 

modulus was an acceptable test to determine whether the relaxation requirement of claim 1 was 

satisfied. (See supra Section 1V.B. 1 .a)(5)(a).) The Court further found that the Del Vecchio 

Test was not an acceptable test for determining whether the relaxation requirement had been 

satisfied and found the data produced from the test unreliable. (See supra Section 

IV.B.1 .a)(5)(b).) Therefore, the Court finds that the evidence shows that, based on the 100% 

modulus test, the Tillotson Gloves relax to initially exerting an initial pressure on the hand and 

thereafter still fitting closely about the hand, but relaxing, within about 6 minutes after the gloves 

is stretched to fit about said hand, to exert on the hand a reduced pressure which is less than 

about 50% of the initial pressure. (CX-45; CX-74.) The Court finds that the Tillotson Gloves 

meet the relaxation claim limitation and other limitations of claim 1 of the ‘616 Patent. 

Therefore, the Court finds that the Tillotson Gloves satisfy the technical prong of the domestic 

industry requirement. 

Assuming that Tillotson failed to establish that the Tillotson Gloves practice the ‘61 6 

Patent, Tillotson still satisfies the domestic industry requirement as set forth below. See inj-a 

Section V1I.B. 

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PUBLIC VERSION 

B. Economic Analysis 

The economic prong of the domestic industry requirement is defined in subsection 

337(a)(3) as follows: 

(3) For purposes of paragraph (2), an industry in the United States shall be 

considered to exist if there is in the United States, with respect to the articles 

protected by the patent, copyright, trademark or mask work concerned - 

(A) Significant investment in plant and equipment; 

(B) Significant employment of labor or capital; or 

(C) Substantial investment in its exploitation, including 

engineering, research and development, or licensing. 

19 U.S.C. 3 1337(a)(3). 

The economic prong of the domestic industry requirement is satisfied by meeting the 

criteria of any one of the three factors listed above. 

The economic domestic industry requirement has been satisfied as per the Initial 

Determination of the Court of May 6,2008 (Order No. 79: Initial Determination Finding That 

Complainant Has Satisfied the Economic Prong of the Domestic Industry Requirement). The 

Commission determined not to review the order. (See Notice of Commission Decision Not to 

Review an Initial Determination Granting A Motion for Summary Determination That The 

Economic Prong of the Domestic Industry Requirement Has Been Met (May 30,2008).) 

As the Staff briefly noted in its initial post hearing brief, Tillotson is also exploiting the 

‘616 Patent through its licensing activities. (SIB at 54-55.) 

Section 337(a)(3)(C) provides for domestic industry based on “substantial investment” in 

the enumerated activities, including licensing of a patent. See Certain Digital Processors and 

Digital Processing Systems, Components Thereox and Products Containing Same, Inv. No. 337- 

TA-559, Initial Determination at 88 (May 11,2007) (“Certain Digital Processors”). Mere 

ownership of the patent is insufficient to satisfjr the domestic industry requirement. Certain 

I15 
PUBLIC VERSION 

Digital Processors at 93. (Citing the Senate and House Reports on the Omnibus Trade and 

Competitiveness Act of 1988, S.Rep. No. 71. However, entities that are actively engaged in 

licensing their patents in the United States can meet the domestic industry requirement. Certain 

Digital Processors at 93. 

complainant does not need to show that it or one of its licensees is practicing a patent-in-suit. 

See Certain Semiconductor Chips with Minimized Chip Package Size and Products Containing 

Same, Inv. No. 337-TA-432, Order No. 13, at 11, (Jan. 24,2001) (“Certain Semiconductor 

Chips”). The complainant must, however, receive revenue, e.g. royalty payments, from its 

licensing activities. Certain Digital Processors, at 93-95 (“Commission decisions also reflect 

the fact that a complainant’s receipt of royalties is & important factor in determining whether the 

domestic industry requirement is satisfied ... [tlhere is no Cornmission precedent for the 

establishment of a domestic industry based on licensing in which a complainant did not receive 

any revenue fiom alleged licensing activities. In fact, in previous investigations in which a 

complainant successfully relied solely on licensing activities to satisfy section 337(a)(3), the 

complainant had licenses yielding royalty payments.”) (citations omitted). See also Certain 

Video Graphics Display Controllers and Products Containing Same, Inv. No. 337-TA-4 12, 

Initial Determination at 13 (May 14, 1 999) ( “Certain Video Graphics Display Controllers ”); 

In establishing a domestic industry under Section 337(a)(3)(C), the 

Certain Integrated Circuit Telecommunication Chips and Products Containing Same Including 

Dialing Apparatus, Inv. No. 337-TA-337, U.S.I.T.C. Pub. No. 2670, Initial Determination at 98 

(March 3, 1993) ( “Certain Integrated Circuit Telecommunication Chips”); Certain ZeroMercury-Added Alkaline Batteries, Parts Thereof and Products Containing Same, Inv. No. 337- 

TA-493, Initial Determination at 142 (June 2,2004) ( “Certain Zero-Mercury-Added Alkaline 

Batteries”); Certain Semiconductor Chips, Order No. 13 at 6 (Jan. 24,2001); Certain Digital 

116 
PUBLIC VERSION 

Satellite System DSS Receivers and Components ThereoA Inv. No. 337-TA-392, Initial and 

Recommended Determinations at 11 (Dec. 4, 1997) (“Certain Digital Satellite System DSS 

Receivers ”). 

The evidence shows that Tillotson continues its licensing-related activities of the ‘61 6 

Patent at its headquarters in Lexington, Massachusetts and at its New Hampshire location where 

it employs seven people substantially involved in licensing and licensing-related activities, 

including identifying, approaching and negotiating with potential licensees, and maintaining and 

enforcing licensing agreements. (CX-788C at Q&A 105-1 15 (Tillotson Direct).) Tillotson also 

expends over $350,000 a year in connection with its licensing of the ‘616 Patent, which has 

resulted in over twenty-two license agreements. (Id. at Q&A 103, 116.) These licenses generate 

revenue of approximately $4 million per year. (Id. at 118.) The evidence shows that the ‘616 

Patent plays an important role in Tillotson’s licensing activities thereby provides a sufficient 

nexus those licensing activities and the ‘616 Patent. (See also Order No. 78 at 5 listing 

Undisputed Findings of Fact.) Therefore, the Court finds that Tillotson has also satisfied the 

domestic industry requirement under 337(a)(3)(C). 

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PUBLIC VERSION 

VIII. CONCLUSIONS OF LAW 

1. The Commission has personal jurisdiction over the parties, and subject-matter 

jurisdiction over the accused products. 

2. The importation or sale requirement of section 337 is satisfied. 

3. The accused gloves listed in Appendix C literally the asserted claims of the ‘616 

Patent 

4. The accused gloves listed in Appendix C do not infringe the asserted claims of the 

‘6 16 Patent under the doctrine of equivalents. 

5. The asserted claims of the ‘616 Patent are invalid under 35 U.S.C. 0 251 7 4 based on 

a broadening reissue amendment more than two years after the issuance of the 

original claims. 

6. The asserted claims of the ‘616 Patent are invalid based upon a deficient reissue 

certificate. 

7. The asserted claims of the ‘616 Patent are not invalid under 35 U.S.C. 

anticipation. 

8. The asserted claims of the ‘616 Patent are not invalid under 35 U.S.C. 3 103 for 

obviousness. 

9. The asserted claims of the ‘616 Patent satisfy the best mode requirement of 35 U.S.C. 

102 for 

5 1127 1. 

10. The asserted claims of the ‘61 6 Patent satisfy the enablement requirement of 35 

U.S.C. 3 112 7 1. 

1 1. The asserted claims of the ‘6 16 Patent satisfy the definiteness requirement of 35 

U.S.C. fj 112 7 2. 

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PUBLIC VERSION 

12. The asserted claims of the ‘616 Patent are enforceable. 

13. A domestic industry exists, as required by section 337. 

14. It has not been established that a violation exists of section 337. 

IX. INITIAL DETERMINATION AND ORDER 

Based on the foregoing, it is the INITIAL DETERMINATION (,‘ID’) of this Court that 

no violation of section 337 of the Tariff Act of 1930, as amended, has occurred in the 

importation into the United States, the sale for importation, or the sale within the United States 

after importation of certain nitrile rubber gloves by reason of infringement of one or more of 

claims 1, 17, 18 and 19 of United States Patent No. Re. 35, 616. The Court further determines 

that a domestic industry exists that practices U.S. Patent No. Re. 35,616. 

Further, this Initial Determination, together with the record of the hearing in this 

investigation consisting of: 

(1) 

ordered, and 

the transcript of the hearing, with appropriate corrections as may hereafter be 

(2) 

exhibit lists in Appendix A, 

the exhibits received into evidence in this investigation, as listed in the attached 

are CERTIFIED to the Commission. In accordance with 19 C.F.R. 5 210.39(c), all material 

found to be confidential by the undersigned under 19 C.F.R. 5 210.5 is to be given in camera 

treatment. 

The Secretary shall serve a public version of this ID upon all parties of record and the 

confidential version upon counsel who are signatories to the Protective Order (Order No. 1 .) 

issued in this investigation, and upon the Commission investigative attorney. 

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PUBLIC VERSION 

RECOMMENDED DETERMINATION ON REMEDY AND BOND 

I. Remedy and Bonding 

The Commission’s Rules provide that subsequent to an initial determination on the 

question of violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 3 1337, the 

administrative law judge shall issue a recommended determination containing findings of fact 

and recommendations concerning: (1) the appropriate remedy in the event that the Commission 

finds a violation of section 337, and (2) the amount of bond to be posted by respondents during 

Presidential review of Commission action under section 3370). See 19 C.F.R. §210.42(a)(l)(ii). 

A. General Exclusion Order 

Under Section 337(d), the Commission may issue either a limited or a general exclusion 

order. A limited exclusion order instructs the U.S. Customs and Border Protection (“CBP”) to 

exclude from entry all articles that are covered by the patent at issue and that originate from a 

named respondent in the investigation. A general exclusion order instructs the CBP to exclude 

from entry all articles that are covered by the patent at issue, without regard to source. 

A general exclusion order may issue in cases where (a) a general exclusion from entry of 

articles is necessary to prevent circumvention of an exclusion order limited to products of named 

respondents; or (b) there is a widespread pattern of violation of Section 337 and it is difficult to 

identifl the source of infringing products. 19 U.S.C. 3 1337(d)(2). The statute essentially 

codifies Commission practice under Certain Airless Paint Spray Pumps and Components 

ThereoJ; Inv. No. 337-TA-90, Commission Opinion at 1 8-1 9, USITC Pub. 1 19 (Nov. 198 1) 

C‘Spray Pumps”). See Certain Neodymium-Iron-Boron Magnets, Magnet Alloys, and Articles 

Containing the Same, lnv. No. 337-TA-372 (“Magnets”), Commission Opinion on Remedy, the 

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PUBLIC WRSION 

Public Interest and Bonding at 5 (USITC Pub. 2964 (1996)) (statutory standards “do not differ 

significantly” from the standards set forth in Spray Pumps). 

In Magnets, the Commission confirmed that there are two requirements for a general 

exclusion order: a “widespread pattern of unauthorized use;” and “certain business conditions 

from which one might reasonably infer that foreign manufacturers other than the respondents to 

the investigation may attempt to enter the U.S. market with infringing articles.” The 

Commission went on to state the following factors as relevant to determining whether there is a 

“widespread pattern of unauthorized use”: 

(1) 

article into the United States by numerous foreign manufacturers; or 

a Commission determination of unauthorized importation of the infringing 

(2) 

corresponding to the U.S. patent; [or] 

the pendency of foreign infringement suits based on foreign patents 

(3) 

of the patented invention. 

other evidence which demonstrates a history of unauthorized foreign use 

Magnets, Commission Opinion on Remedy, the Public Interest, and Bonding at 6 (citing Spray 

Pumps). 

In addition, the Commission listed the following factors as relevant to showing whether 

“certain business conditions” - the second Spray Pumps factor - exist: 

(1) 

and conditions of the world market; 

the existence of an established demand for the article in the US. market 

(2) 

distribution networks; 

the availability to foreign manufacturers of U.S. marketing and 

(3) 

patented articles; 

the cost for foreign entrepreneurs to build a facility that can produce the 

(4) 

to manufacture the patented article; and 

the number of foreign manufacturers whose facilities could be converted 

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PUBLIC VERSION 

(5) 

patented articles. 

the foreign manufacturers’ cost to convert a facility to produce the 

Id. 

Tillotson requests that a general exclusion order be issued that prohibits the importation 

of all infringing nitrile gloves. (CIB at 90.) 

1. Widespread Pattern of Unauthorized Use 

Tillotson argues that there is a widespread pattern of unauthorized use of the invention 

described and claimed in the ‘616 Patent. (CIB at 90.) Tillotson argues that Respondents have 

imported and sold approximately 1 1.7 billion nitrile gloves in the United States since January 

2003 and that over 90% of the approximately 230 gloves manufactured and/or sold by 

Respondents infringe claim 1 of the ‘616 Patent. (Id. at 90.) Tillotson fbrther argues that it has 

entered into license agreements with more than 40 manufacturers and distributors and that the 

licensees have admitted to importing and selling infringing gloves in United States. (Id. at 90.) 

Respondents argue that Tillotson deliberately chose not to name a majority of accused 

infringers, despite having the ability to track them down. (RIB at 94.) Respondents point to the 

fact that Tillotson filed a complaint in the Northern District of Georgia one day after filing a 

complaint with the ITC, which named 253 but Tillotson failed to name those 

defendants in the current investigation. (Id. at 94.) Respondents further argue CBP would likely 

be incapable of administering the general exclusion order due to the limited resources available 

to it. (Id. at 94-95.) Respondents further argue that since it is difficult for CBP to determine 

whether an imported product infringes since specialized testing and equipment is often required, 

Respondents assert that should the Commission find a violation, then a limited exclusion order 

26 Respondents argue that none of the defendants in the U.S. District Court case are domestic producers of gloves. 

122 
PUBLIC VERSION 

along with a certification by the respondent that the imported goods are not covered by the 

asserted claims of the patent. (Id. at 95-96.) 

Staff argues that the evidence shows that a vast majority of Respondents’ gloves in this 

investigation infringe the ‘6 16 Patent and are imported in significant quantities into the United 

States. (SIB at 58.) 

2. Business Conditions 

Tillotson argues that there is an established demand for nitrile gloves embodied in the 

‘6 16 Patent; that Tillotson’s licensee, Best Glove Inc., continues to manufacture and sell the NDEX glove; that Respondents have imported and sold billions of infringing nitrile gloves; and 

that the nitrile glove market is expected to continue to grow and expand. (Id. at 91 .) Tillotson 

further argues that marketing and distribution networks exist for use by foreign manufacturers, 

including the networks of Best Glove, Tillotson’s other licensees, those of certain Respondents 

and other distributors. (Id. at 91-92.) Tillotson further argues that it would not be costly for a 

foreign manufacturer to construct a new nitrile glove production line or to retool latex glove 

production lines, of which there are hundreds, to produce nitrile gloves. (Id. at 91 -93 .) 

Staff argues that certain business conditions exist such that other foreign manufacturers 

may attempt to enter the U.S. market; that there is an established market and demand for nitrile 

gloves; there are a significant number of distributors that could be utilized by foreign 

manufacturers; and that there are minimal barriers to foreign manufacturers constructing a new 

nitrile production line or retooling an existing glove line. (SIB at 59-60.) As such, should the 

Commission find a violation of Section 337, Staff supports the general exclusion order. (Id. at 

60.) 

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PUBLIC VERSION 

3. Risk of Circumvention 

Tillotson further argues that there is a substantial risk of circumvention absent a general 

exclusion order. (CIB at 93.) Tillotson argues that a general exclusion order is required to 

capture all of the infringing nitrile gloves imported and sold in the United States. (Id. at 93.) 

Tillotson argues that it is impossible to identify all of the companies currently importing and 

selling nitrile gloves in the United States because they are not required to identify the imported 

goods as “nitrile gloves,” but can use other descriptions such as “medical synthetic glove” 

instead. (Id. at 93-94.) Tillotson further argues that given the numerous different companies in 

different countries who manufacture, distribute, sell and market disposable medical gloves, it is 

even more difficult to identify the companies and increases the likelihood of circumvention and 

that a limited exclusion order would simply cause other companies to enter into the glove market. 

(Id. at 94.) 

Respondents argue that Tillotson has failed to present any evidence showing that 

circumvention would occur. (RIB at 91 .) Respondents further argue that the mix of allegedly 

infringing and non-infringing products that compete on equal footing makes a general exclusion 

order inappropriate and that there is no incentive for circumvention. (Id. at 9 1-92.) Respondents 

further argue that should the Commission issue a general exclusion order, it would provide 

powerful incentive for unlicensed manufacturers and importers to develop and purchase nitrile 

gloves that design around the limitations of the ‘61 6 Patent and avoid the significant legal risks 

in attempting to circumvent the exclusion order. (Id. at 92-93 .) 

Staff argues that ample evidence exists to demonstrating the need for a general exclusion 

order to prevent circumvention of a limited exclusion order. (SRB at 20-21 .) Staff further 

argues that the Commission can also crafl a general exclusion order that includes a certification 

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PUBLIC VERSION 

requirement in order to alleviate the burden on the CBP in enforcing the general exclusion 

0rder.2~ (Id. at 21-22.) 

4. Conclusion 

The Court agrees that the evidence supports a general exclusion order should the 

Commission find a violation of Section 337. The evidence shows that there is a widespread 

pattern of unauthorized use: over 90% of Respondents’ accused nitrile gloves were found to 

infringe the ‘61 6 Patent and Respondents have imported and sold approximately 1 1.7 billion 

nitrile gloves in the U.S. since January 2003. (See supra Section I1 (Importation); Section IV 

(Infringement); CX-787C at Q&A 104 (Tanger Direct); ROCFF VII. 2.) The evidence further 

shows that certain business conditions exist supporting the issuance of a general exclusion order. 

Specifically, the evidence shows that there is an established demand for nitrile gloves and that 

such a market is expected to continue to grow in the coming years (CX-308, 74; CX-457,7 4; 

CX-460C f 18; CX-467C 714; CX-492C; CX-825; CX-788C (Tillotson Direct) at Q&A 32; CX787C at 73, 86 (Tanger Direct); Tanger, Tr. 541:s-16,565:7-11.); marketing and distribution 

networks are readily available to foreign manufacturers (Tanger, Tr. 599:20-600:s; CX-282C; 

CX-176C 7 333; CX-308C 7 4; CX-457C 714; CX-460C 7 18; CX-467C 7 14; CX-501C 7333; 

CX-503C f 333; CX-506C f 333; CX-508C f 333; CX-509C f 333; CX-5317 333; CX-535C 7 

333; CX-787C at Q&A75-76 (Tanger Direct); CX-837C at Q&A 67 (Tillotson Direct); CX-838C 

at Q&A 75 (Tanger Rebuttal)); and the cost for foreign manufacturers to start-up a nitrile 

production line or retool a latex glove production line are relatively low in light of the profit 

potential (Tanger Tr., 538:l-18 , 566:5-9,569:lO-25, 572:2-24; CX-291C; CX-787C at Q&A 83- 

86,88-95, 191,216 (Tanger Direct); CX-783). The evidence further shows that a general 

27 Tillotson argues that the Commission should not include a certification provision, but that should the 

Commission decide to do so Tillotson requests the opportunity to work with Staff and the CBP in fashioning an 

appropriate certification provision. (CRB at 45.) 

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PUBLIC VERSION 

exclusion order is appropriate to prevent circumvention of a limited exclusion order, especially 

since there is a significant market and demand for nitrile gloves, the barrier to entry into the 

nitrile glove market is minimal, and extensive marketing and distribution networks are available 

to foreign manufacturers. (See supra; See also Tanger, Tr. 583:5-17, 1393:16-1395:9). 

The Court Mher recommends that the Commission should include a certification 

provision in the exclusion order in order. 

B. Limited Exclusion Order 

Under Section 337(d), the Commission may issue either a limited or a general exclusion 

order. A limited exclusion order directed to respondents’ idringing products is among the 

remedies that the Commission may impose, as is a general exclusion order that would apply to 

all infringing products, regardless of their manufacturer. See 19 U.S.C. 0 1337(d). 

Tillotson requests that, should the Commission deny its request for general exclusion 

order, a limited exclusion order be issued that prohibits the importation of all infringing nitrile 

gloves by Respondents and all of their affiliated companies, parents, subsidiaries, or other related 

business entities of their successors or assigns. (CIB at 94-95.) 

Respondents assert that should a limited exclusion order be issued, the Cornmission 

should include a certification requirement given the large number of non-infringing gloves. (RIB 

at 95; RRB at 45.). 

Staff asserts that a limited exclusion order as to the infringing nitrile gloves imported by 

or on behalf of Respondents would be appropriate and that any such limited exclusion order 

should apply to Respondents and any affiliated companies, parents, subsidiaries or other related 

business entities, or their successor or assigns. (SIB at 60-61 .) Staff argues, however, that the 

exclusion order should apply only to the gloves identified by Tillotson as infringing, but should 

126 
PUBLIC VERSION 

not apply to all nitrile gloves imported, sold for importation or sold after importation by 

Respondents. (Id. at 61 .) Staff argues that the limited exclusion order should be limited to those 

gloves identified in Appendix B of its initial post-hearing brief. 

The Court agrees that the evidence shows that, if a violation is found and the Commission 

decides not to issue a general exclusion order, a limited exclusion order would be proper. The 

limited exclusion order should apply to Respondents and all of their affiliated companies, parents, 

subsidiaries, or other related business entities, or their successors or assigns and should be 

limited to those of Respondents’ gloves that have been found to infringe the ‘616 Patent, as set 

forth in Appendix C. The Court further recommends that the Commission should include a 

certification provision in the exclusion order in order. 

C. Cease and Desist Order 

Section 337 provides that in addition to, or in lieu of, the issuance of an exclusion order, 

the Commission may issue a cease and desist order as a remedy for violation of section 337. See 

19 U.S.C. 5 1337(f)(l). The Commission generally issues a cease and desist order directed to a 

domestic respondent when there is a “commercially significant” amount of infringing, imported 

product in the United States that could be sold so as to undercut the remedy provided by an 

exclusion order. See Certain Crystalline Cefadroxil Monohydrate, Inv. No. 337-TA-293, USITC 

Pub. 2391, Comm’n Op. on Remedy, the Public Interest and Bonding at 37-42 (June 1991); 

Certain Condensers, Parts Thereof and Products Containing Same, Including Air Conditioners 

for Automobiles, Inv. No. 337-TA-334, Comm’n Op. at 26-28 (Aug. 27, 1997). 

Tillotson requests a cease and desist order against each of the Respondents based in the 

United States as they all have, or the Court should infer that they have, significant inventories of 

nitrile gloves in the United States. (CIB at 95-97.) 

127 
PUBLIC VERSION 

Staff argues that a cease and desist order should be issued only against those Respondents 

for which the evidence shows that these entities maintain a commercially significant inventory of 

nitrile gloves.28 (SIB at 63.) Staff argues, however, that Tillotson has failed to present any 

evidence of commercially significant inventories for the remaining respondents and that the 

Court should not infer that these entities contain significant inventories of nitrile gloves based on 

mere affiliation. (Id. at 63.) 

The Court agrees that the evidence shows that Ansell Healthcare Products LLC, Ansell 

Protective Products Inc., Protective Industrial Products Inc., Adenna, Inc., Liberty Glove, Inc., 

QRF’ Inc., Dentexx Nevada Inc., Henry Schein Inc., HSI Inc., Cardinal Health 200, Inc. maintain 

significant inventories of nitrile gloves in the United States and that if a violation is found, a 

cease and desist order is warranted. (CX-461C, Ex. D; CX-308, ’I[ 5; CX-238,y 3; CX-46OC, 7 

10; CX-235C 7 4; CX-458C7 73; CX-456C, 7 4; CX-467C, Ex. E.) The Court further agrees that 

for those domestic respondents found in default, Basic Medical Industries, Medtexx Partners, Inc. 

and Dash Medical, a cease and desist order is also warranted. The Court, however, will not 

“infer” that Kossan Gloves, Inc. d/b/a Sintex, Pharmatex USA Inc., Shamrock Manufacturing 

Co., Inc., and TG Medical have significant inventories and, as such, does not recommend a cease 

and desist order be issued against those en ti tie^.^' 

28 Staff argues that these include Ansell Healthcare Products LLC, Ansell Protective Products Inc., Protective 

Industrial Products Inc., Tronex International, Adenna, Inc., Liberty Glove, Inc., QRP Inc., Dentexx Nevada Inc., 

Henry Schein Inc., HSI Inc., Cardinal Health 200, Inc. (SIB at 63.) 

of a foreign named respondent, for failing to comply with Order No. 75. On May 19,2008, these respondents 

responded to the motion for sanctions arguing that as a subsidiary of a parent respondent, any responsive 

information in the possession of the subsidiary was produced by the parent respondent prior to the addition of the 

subsidiary in this investigation. On May 2 1,2008, the Court denied the motion for sanctions. (Tr. 622:2-7.) 

On May 7,2008, Tillotson tiled a motion for sanctions against these respondents, each of which is a subsidiary 29 

128 
PUBLIC VERSION 

D. Bond During Presidential Review Period 

The Administrative Law Judge and the Commission must determine the amount of bond 

to be required of a respondent, pursuant to section 337(i)(3), during the 60-day Presidential 

review period following the issuance of permanent relief, in the event that the Commission 

determines to issue a remedy. The purpose of the bond is to protect the complainant from any 

injury. 19 C.F.R. 0 210.42(a)(l)(ii), 4 210.50(a)(3). 

When reliable price information is available, the Commission has often set the bond by 

eliminating the differential between the domestic product and the imported, infringing product. 

See Certain Microsphere Adhesives, Processes for Making Same, and Products Containing Same, 

Including Self-stick Repositionable Notes, Inv. No. 337-TA-366, Comm’n Op. a 24 (1995). In 

other cases, the Commission has turned to alternative approaches, especially when the level of a 

reasonable royalty rate could be ascertained. See, e.g., Certain Integrated Circuit 

Telecommunication Chips and Products Containing Same, Including Dialing Apparatus, Inv. No. 

337-TA-337, Comm’n Op. at 41 (1995). A 100 percent bond has been required when no 

effective alternative existed. See, e.g., Certain Flash Memory Circuits and Products Containing 

Same, Inv. No. 337-TA-382, USITC Pub. No. 3046, Comm’n Op. at 26-27 (July 1997)(a 100% 

bond imposed when price comparison was not practical because the parties sold products at 

different levels of commerce, and the proposed royalty rate appeared to be de minimis and 

without adequate support in the record). 

Tillotson requests a bond be set in the amount of 100% of the entered value of accused 

products, or a bond be set at the minimum royalty rate paid by Tillotson’s licensees, which is 

approximately $2.00 per thousand nitrile gloves. (CIB at 97-98.) Respondents argue that the 

bond should be set at Tillotson’s minimum royalty rate of $2.00 per thousand nitrile gloves. 

129 
PUBLIC VERSION 

(RIB at 96.) Staff agrees that the bond should be set at Tillotson’s standard royalty rate of $2.00 

per thousand nitrile gloves. (SIB at 64.) 

In this case, a reasonable royalty rate can be ascertained, namely Tillotson’s standard 

royalty rate of $2.00 per thousand nitrile gloves. Accordingly, the Court recommends a bond in 

the amount of $2.00 per thousand nitrile gloves. 

11. Conclusion 

In accordance with the discussion of the issues contained herein, it is the 

RECOMMENDED DETERMINATION (“RD”) of the Court that in the event the Commission 

finds a violation of section 337, the Commission should issue a general exclusion order that 

includes a certification provision. Should the Commission decide not to issue a general 

exclusion order, the Commission should issue limited exclusion order directed only to those 

Respondents’ nitrile gloves that were found to infringe the ‘616 Patent as listed in Appendix C. 

The Commission should also issue a cease and desist order directed toward the domestic 

respondents identified supra. (See Remedy, Section I.C.) Furthermore, if the Commission 

imposes a remedy following a finding of violation, Respondents should be required to post a 

bond of $2.00 per thousand nitrile gloves imported during the Presidential review period. 

Within seven days of the date of this document, each party shall submit to the office of 

the Administrative Law Judge a statement as to whether or not it seeks to have any portion of 

this document deleted from the public version. The parties’ submissions must be made by hard 

copy by the aforementioned date. 

Any party seeking to have any portion of this document deleted from the public version 

thereof must submit to this office a copy of this document with red brackets indicating any 

portion asserted to contain confidential business information by the aforementioned date. The 

130 
PUBLIC VERSION 

parties' submission concerning the public version of this document need not be filed with the 

Commission Secretary. 

SO ORDERED. 

Administrative Law Judge 

131 
IN THE MATTER OF CERTAIN NITRILE GLOVES 337-TA-608 & 337-TA-612 

CERTIFICATE OF SERVICE - Pape 2 

RESPONDENT DYNAREX CORPORATION: 

Merritt R. Blakeslee, Esq. 

DEKIEFFER & HORGAN 

729 Fifteenth Street, N.W., Suite 800 

Washington, DC 20005 

FOR RESPONDENTS 

HARTALEGA HOLDINGS Bhd. 

JDA (TIANJIN) PLASTIC RUBBER CO. LTD 

KOSSAN RUBBER INDUSTRIES Bhd. Ltd. 

LAGLOVE (M) Sdn. Bhd. 

LATE= PARTNERS BERHAZ) 

PT MEDISAFE TECHNOLOGIES 

PT SHAMROCK MANUFACTURING CORPORATION 

RIVERSTONE RESOURCES Sdn. Bhd. 

YTY HOLDINGS Sdn. Bhd. 

TOP GLOVE CORPORATION Bhd.: 

Perry R. Clark, Esq. 

Jenny Lee, Esq. 

Kenny Nguyen, Esq. 

KIRKLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

( ) Via Hand Delivery 

( ia Overnight Mail 

( ) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

ia Overnight Mail 

ia First Class Mail 

( )Other 

RESPONDENT SMART GLOVE HOLDINGS, Sdn.Bhd. and HENRY SCHEIN, INC. 

& HSI GLOVES INC.: 

Scott M. Daniels, Esq. ( ) Via Hand Delivery 

WESTERMAN, HATTORI, DANIELS ( ia Overnight Mail 

& ADRIAN, LLP ( ) Via First Class Mail 

1250 Connecticut Avenue, N. W. ,Suite 700 ( )Other 

Washington, DC 20036 

RESPONDENT LIBERTY GLOVE, INC.: 

Rosa S. Jeong, Esq. 

GREENBERG TRAURIG, LLP 

2101 L Street, NW 

Washington, D.C. 20037 

( ) Via Hand Delivery 

( a Overnight Mail 

( la First Class Mail 

( ) Other 
IN THE MATTER OF CERTAIN NITRILE GLOVES 337-TA-608 & 337-TA-612 

PUBLIC CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached INITIAL DETERMINATION OF 

SECTION 337 AND RECOMMENDED DETERMINATION ON RICMEDY AND BOND 

has been served by hand upon the Commission Investigative Attorney, Erin D.E. Joffre, Esq., 

and the following parties as indicated below on February lo’ ,2009. 

U.S. International Trade Commission 

500 E Street, S.W., Room 112A 

Washington, DC 20436 

COMPLAINANT TILLOTSON CORPORATION: 

Gilbert B. Kaplan, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, N. W. 

Washington, DC 20006-4706 

( ) Via Hand Delivery 

( ia Overnight Mail 

( ) Via First Class Mail 

( )Other: 

RESPONDENT ANSELL LTD.: 

Thomas B. Kenworthy, Esq. ( ) Via Hand Delivery 

Rebecca J. Hillyer, Esq. ( ia Overnight Mail 

MORGAN, LEWIS & BOCKIUS LLP ) Via First Class Mail 

1701 Market Street ( )Other: 

Philadelphia, PA 19 103-292 1 

( 

RESPONDENTS CARDINAL HEALTH, INC., CARDINAL HEALTH 200, INC. & 

CARDINAL HEALTH MALAYSIA 211 Sdn. Bhd.: 

Paul F. Brinkman, Esq. 

ALSTON & BIRD LLP 

950 F Street, N.W. 

Washington, DC 20004- 1404 

Via Hand Delivery 

Overnight Mail 

) Via First Class Mail ( 

( )Other 
IN THE MATTER OF CERTAIN NITRILE GLOVES 337-TA-608 & 337-TA-612 

CERTIFICATE OF SERVICE - Page 3 

RESPONDENT PROTECTIVE INDUSTRIAL PRODUCTS, INC.: 

Elizabeth Borland, Esq. 

SMITH, GAMBRELL, AND RUSSELL LLP 

Promenade 11, Suite 3 100 

Atlanta, GA 30309 

RESPONDENT TRONEX INTERNATIONAL, INC.: 

Maureen F. Browne, Esq. 

HELLER EHRMAN, LLP 

17 17 mode Island Avenue, N. W. 

Washington, DC 20036-3001 

RESPONDENT QRP INC. d/b/a QRP GLOVES: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL P.L.C. 

2730 E. Broadway Blvd., Suite 160 

Tucson, AZ 85716-5384 

RESPONDENTS ADENNA, INC.: 

Douglas A. Frymer, Esq. 

498 1 Inwindale Avenue, Suite 100 

Inwindale, CA 9 1706 

DASH MEDICAL GLOVES, INC. 

c/o Robert J. Sullivan 

10 1 8 South 54'h Street 

Franklin, WI 53132 

DENTEXWF'IRST MEDICA INFECTION 

CONTROL ASSOCIATE 

3704C Boren Drive 

Greensboro, NC 27407 

( ) Via Hand Delivery 

ia Overnight Mail 

ia First Class Mail 

( )Other 

( ) Via Hand Delivery 

) Via Overnight Mail 

( ) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

Via Overnight Mail 

( ) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

) Via Overnight Mail 

) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

ia Overnight Mail 

( ) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

( a Overnight Mail 

( a First Class Mail 

( )Other 
IN THE MATTER OF CERTAIN NITRILE GLOVES 337-TA-608 & 337-TA-612 

CERTIFICATE OF SERVICE - Pa& 

RESPONDENT DENTEXX NEVADA, INC. AND FIRST MEDICA 

INFECTION CONTROL ASSOCIATES, INC.: 

James Lester, Esq. 

MACCORD MASON PLLC 

1600 Wachovia Tower 

300 N. Greene Street 

Greensboro, NC 2740 1 

Ansell (Thailand) Ltd. 

Chalonghg Road 

Bangkok, Thailand 10520 

' llOMoo4 

Ansell Healthcare Products LLC 

200 Schulz Drive 

Red Bank, NJ 07701 

Ansell Protective Products Inc. 

200 Schulz Drive 

Red Bank, NJ 07701 

( ) Via Hand Delivery 

' Via Overnight Mail 

Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

ia Overnight Mail 

ia First Class Mail 

( )Other 

( ) Via Hand Delivery 

Via Overnight Mail 

Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

ia Overnight Mail 

ia First Class Mail 

( )Other 

Top Glove Sdn. Bhd. ( ) Via Hand Delivery 

Lot 4968 ) Via Overnight Mail 

Jalan Teratai ) Via First Class Mail 

Batu 6 ( )Other 

Off Jalan Meru,4 1050 Klang 

Selangor D.E. 

Malaysia 

TG Medical (USA) Inc. 

165 North Aspen Ave. 

Azusa, CA 91 702 

Hartalega Sdn. Bhd. 

Lot 9 

Jalan Kuang Bulan 

Taman Kepong Industrial Estate 

52100 Kuala Lmpur 

( ) Via Hand Delivery 

Via Overnight Mail 

Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

( a Overnight Mail 

( ia First Class Mail 

( )Other 
IN THE MATTER OF CERTAIN NITRILE GLOVES 337-TA-608 & 337-TA-612 

Malaysia 

CERTIFICATE OF SERVICE - Page 5 

RESPONDENT DENTEXX NEVADA, INC. AND FIRST MEDICA 

INFECTION CONTROL ASSOCIATES, INC.: 

Pharmatex USA Inc. 

77530 Enfield Lane Bldg. 1, Suite 203 

Palm Desert, CA 9221 1 

Perusahaan Getah Asas Sdn. Bhd. 

Lot 754 

Jalan Haji Sirat 

Off Jalan Kapur 

42 100 Klang, Selangor D.E. 

Malaysia 

Kossan Gloves Inc. d/b/a Sintex 

168 10 Baker Springs #2 19 

Houston, TX 77084 

( ) Via Hand Delivery 

Via Overnight Mail 

( ) Via First Class Mail 

( ) Other 

( ) Via Hand Delivery 

) Via Overnight Mail 

( ) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

) Via Overnight Mail 

( ) Via First Class Mail 

( )Other 

PT Haloni Jane ( ) Via Hand Delivery 

JL. Raya Serang KM 13.8 Cikupa Tangerang -- ) Via Overnight Mail 

Indonesia ) Via First Class Mail 

( )Other 

Shamrock Manufacutring Company Inc. ( ) Via Hand Delivery 

5445 Daniels Street ) Via Overnight Mail 

Chino, CA 91710 ) Via First Class Mail 

( )Other 

Smart Glove Corporation Sdn. Bhd. 

Lot 6487 

Batu 5 3f4 

Sementajln Kapar, 42100 Klang 

Selangor D.E., Malaysia 

YTY Industry (Manjung) Sdn. Bhd. 

Batu 10 Lekir, 32020 Sitiawan 

Per& Dam1 Ridzuan, Malaysia 

Lot 1422- 1424 

( ) Via Hand Delivery 

) Via Overnight Mail 

) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

Via Overnight Mail 

Via First Class Mail 

( )Other 
IN THE MATTER OF CERTAIN NITRILE GLOVES 337-TA-608 & 337-TA-612 

CERTIFICATE OF SERVICE - Pwe 6 

PUBLIC MAILING LIST 

Sherry Robinson 

8891 Gander Creek Drive 

Miamisburg, OH 45342 

LEXIS - NEXIS 

Kenneth Clair 

Thomson West 

1100 - 13' Street NW 

Suite 200 

Washington, DC 20005 

( ) Via Hand Delivery 

) Via Overnight Mail 

) Via First Class Mail 

( )Other 

( ) Via Hand Delivery 

ia Overnight Mail 

( ) Via First Class Mail 

( )Other 

UNITED STATES INTER."!ATlONAL TRADE COMMISSION 

W .... im~ D.C. lIJo436 

I .... Matl ... of 

CERTAIN NITRILE GLOVES 

CERTAIN NITRILE RUBBER GLOVES 

NOTICE OF COM.VlISSION DITERMINA nON NOT TO RtViEW AN INITIAL 

DITERMINA nON FINDING il£SI'ONDf.NT DASH MEDICAL GLOVES, INC. IN 

DEPAULT 

AGENCY: U.S. International Trade C<>mmiooioo.. 

ACllON: Noti.,.. 

SUMMARY: Noti.,. is h=:by iivenlbat tile U.S. llltemaIionoiTradeCommi.soiou ""' 

<i<1om>iDod no< to ""';ow the p.aidina odminiSlJali ... low jooll<"'. ,AU") initial doterminotioo 

,IDj (Older No. 92) in the abo ... ·"'ferenced in .... iption findina mpondent u..b Medical 

Oloves,!no. ,o..h") in d<fauJ1. 

FOR FURTHER INFORMA nON CONT Acr: Michelle Walte-rJ. omce of the Oenmol 

Counool. U.S. tnternotional Trade Commi.soioa. 500 E SU"ffi. S.W .• Woshington. D.C. 21)436. 

telephone (202) 10«·5461. C<>pieo of lIOIKXHIMen(ial documents filed in connection with !hi. 

inveotiption .... 0< will be avoll&ble for lnspe<1ion duril\ll ofllcia) 1:-"1,,... bours (':45 o.m. 10 ':1' p.m.) in tbe Off""", "ftbe SecmaIy. U.S. In!ema!lonalTradeCommissioo.SO!) E St=t. 

S. W .• WodJUWon. D.C. 21)436. telephone (202) 205·2000. (lenenl information ~ the 

Commission may olIO be oI:uinod by ~i"i its Interne! ..,....,. .. "'m-0rwtr UWg<>l'. Th< 

public""""" for!hi. im· .. tiption may be viewed on the Commission' •• loctn>oic docket 

(EDlS) 01 ilwl"lltdis ... itc.W!. Huring.impiOiml...,..,.,. .... ad-.-ioed thai inf<>mlotioo on !hi, 

.... tter can be _ by OOIllai:tiDol the Coouni;;i",,·. TDD temtinal on (2(12) 205-1 310. 
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation, on July 

6,2007, based on a complaint filed by Tillotson Corporation d.b.a. Best Manufacturing Company 

(“Tillotson”). The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 

U.S.C. 0 1337) in the importation into the United States, the sale for importation, and the sale 

within the United States after importation of certain nitrile gloves by reason of infringement of 

various claims in United States Patent No. Re. 35,6 16. The complaint named over thirty 

respondents, including Dash. On September 19,2007, the ALJ consolidated Inv. No. 337-TA608 With I~v. NO. 337-TA-612. 

On July 1,2008, Tillotson filed a motion for an order to show cause and default against 

respondent Dash. On July 18,2008, the ALJ issued Order No. 90 ordering respondent Dash to 

show cause why it should not be found in default for failing to respond to the complaint and 

notice of investigation by July 25,2008. 

As of August 1 , 2008, no response to the order had been filed by respondent Dash and the 

ALJ issued the subject ID finding Dash in default. As a consequence, the ALJ found that Dash 

had waived its right to appear, to be served with documents, and to contest the allegations against 

it. No petitions for review of this ID were filed. 

The Commission has determined not to review the ID. 

The authority for the Commission’s determination is contained in section 337 of the 

TariffAct of 1930, as amended (19 U.S.C. 5 1337), and in section 210.42 of the Commission’s 

Rules of Practice and Procedure (19 C.F.R. 3 210.42). 

By order of the Commission. 

Marilyn R. Abbov 

Secretary to the Commission 

Issued: August 20,2008 

2 
CERTAIN NITRILE GLOVES AND 

CERTAIN NITRILE RUBBER GLOVES 

337-TA-608 and 612 

(Consolidated) 

PUBLIC CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached NOTICE OF COMMISSION 

DETERMINATION NOT TO REVIEW AN INITIAL DETERMINATION 

FINDING RESPONDENT DASH MEDICAL GLOVES, INC. IN DEFAULT has 

been served by hand upon the Commission Investigative Attorney Vu Q. Bui, Esq., and 

the following parties as indicated, on 

August 21, 2008 

&d/ 

N@ U.S. International Trade Commission 

500 E Street, SW 

Washington, DC 20436 

ON BEHALF OF COMPLAINANT TILLOTSON 

CORPORATION: 

Gilbert B. Kaplan, Esq. 

Jeffkey M. Telep, Esq. 

Taryn L. Koball, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, NW 

Suite 200 

Washington, DC 20006-4706 

P-202-737-0500 

F-202-626-3737 

Anthony B. Askew, Esq. 

Katrina M. Quicker, Esq. 

Jason M. Pass, Esq. 

KING & SPALDING LLP 

1 180 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-572-4600 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

k) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

) Via First Class Mail 

( )Other: 
Page 2 - Certificate of Service 

F-404-572-5 100 

Gregory C. Doris, Esq. 

Charles H. Carpenter, Esq. 

Sean P. Bamford, Esq. 

PEPPER HAMILTON LLP 

Hamilton Square 

600 Fourteenth Street, NW 

Washington, DC 20005-2004 

P-202-220-1200 

F-202-220- 1665 

William D. Belanger, Esq. 

Aaron J. Levangie, Esq. 

Michael T. Renaud, Esq. 

PEPPER HAMILTON LLP 

125 High Street 

1 5th Floor, Oliver Street Tower 

Boston, MA 021 10-2736 

P-6 17-204-5 100 

F-617-204-5150 

ON BEHALF OF RESPONDENTS TOP GLOVE 

CORPORATION Bhd, LAGLOVE (M) Sdn. 

Bhd.,HARTALEGA HOLDINGS Bhd., KOSSAN 

RUBBER INDUSTRIES Bhd., Ltd., FUVERSTONE 

RESOURCES Sdn. Bhd., YTY HOLDINGS Sdn. Bhd. I 

PT MEDISAFE TECHNOLOGIES, JL, PT 

SHAMROCK, LATEXX PARTNERS BERHAD and 

JDA (Tianiin) PLASTIC RUBBER COMPANY, 

LIMITED : 

Perry R. Clark, Esq. 

Jenny N. Lee, Esq. 

Michael T. Pieja, Esq. 

KIRKLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

P-415-439-1400 

F-415-439- 1500 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

k) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(X) Via First Class Mail 

( )Other: 
Page 3 - Certificate of Service 

ON BEHALF OF RESPONDENTS ANSELL 

HEALTHCARE PRODUCTS LLC, ANSELL 

PROTECTIVE PRODUCTS, INC., AND ANSELL 

[THAILAND) LIMITED: 

Thomas B. Kenworthy, Esq. 

David W. Marston, Esq. 

Kenneth J. Davis, Esq. 

MORGAN LEWIS & BOCKIUS LLP 

1701 Market Street 

Philadelphia, PA 19 103-292 1 

P-215-963-5000 

F-215-963-5001 

ON BEHALF OF RESPONDENT QRP 

INCORPORATED: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL, PLC 

2730 E. Broadway Boulevard, Suite 160 

Tucson, AZ 85716-5384 

P-520-326-4600 

F-520-203-0202 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( ) Other: - 
Page 4 - Certificate of Service 

ON BEHALF OF RESPONDENT PROTECTIVE 

INDUSTRIAL PRODUCTS, INCORPORATED: 

J. Rodgers Lunsford, 111, Esq. 

Elizabeth G. Borland, Esq. 

Suzannah K. Sundby, Esq. 

SMITH GAMBRELL & RUSSELL, LLP 

Promenade 11, Suite 3 100 

1230 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-8 15-3500 

F-404-815-3509 

ON BEHALF OF RESPONDENT ADENNA, 

INCORPORATED: 

Douglas A. Frymer, Esq. 

498 1 Irwindale Avenue 

Suite 100 

Irwindale, CA 9 1706 

P-626-8 13-7076 

ON BEHALF OF RESPONDENTS BEIJING 

. HUATENG RUBBER PLASTIC & LATEX 

PRODUCTS COMPANY, LTD.: 

Mark L. Hogge, Esq. 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

GREENBERG TRAURIG LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-33 1-3 100 

F-202-331-3101 

Brad Bertoglio, Esq. 

WOOD PHILLIPS 

500 West Madison Street 

Suite 3800 

Chicago, IL 60661-2562 

P-312-876-2105 

F-3 12-876-2020 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

@) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

$) Via First Class Mail 

( )Other: 
Page 5 - Certificate of Service 

ON BEHALF OF RESPONDENT TRONEX 

INTERNATIONAL, INCORPORATED: 

Maureen F. Browne, Esq. 

Jenny L. Workman, Esq. 

HELLER EHRMAN LLP 

17 17 Rhode Island Avenue, NW 

Washington, DC 20036 

P-202-912-2000 

F-202-912-2020 

ON BEHALF OF RESPONDENT LIBERTY GLOVE, 

INCORPORATED: 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

Mark L. Hogge, Esq. 

GREENBERG TRAURIG, LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-331-3100 

F-202-331-3101 

ON BEHALF OF RESPONDENTS CARDINAL 

HEALTH, INC., CARDINAL HEALTH 200, INC., AND 

CARDINAL HEALTH MALAYSIA 211 SDN BHD: 

Paul F. Brinkman, Esq. 

Jeffrey Schwartz, Esq. 

ALSTON & BIRD LLP 

950 F Street, NW 

Washington, DC 20004 

P-202-756-3300 

F-202-756-3333 

Michael S. Connor, Esq. 

Jessica J. Sibley, Esq. 

ALSTON & BIRD LLP 

101 South Tyron Street, Suite 4000 

Charlotte, NC 28280 

P-704-444- 1000 

F-704-444-1111 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(X) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(x) Via First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(X) Via First Class Mail 

( )Other: 
Page 6 - Certificate of Service 

Robert M. Mitchell, Esq. 

Angela Payne James, Esq. 

Elizabeth Kemmerer Haynes, Esq. 

ALSTON & BIRD LLP 

1201 West Peachtree Street 

Atlanta, GA 30309-3424 

P-404-88 1-7000 

F-404-88 1-7777 

ON BEHALF OF RESPONDENTS HENRY SCHEIN, 

INC. AND HSi GLOVES, INC.: 

Scott M. Daniels, Esq. 

Ken-Ichi Hattori, Esq. 

Ryan B.Chirnomas, Esq. 

WESTERMAN, HATTORI, DANIELS 

& ADRIAN, LLP 

1250 Connecticut Avenue, NW - Suite 700 

Washington, DC 20036 

P-202-822- 1 100 

F-202-822-1111 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

F) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(X) Via First Class Mail 

( ) Other: 

ON BEHALF OF RESPONDENT SMART GLOVE 

HOLDINGS Sdn. Bhd.,: 

Scott M. Daniels, Esq. 

Ken-Ichi Hattori, Esq. 

Ryan B. Chimomas, Esq. 

WESTERMAN, HATTORI, DANIELS & ADRIAN 

LLP 

1250 Connecticut Avenue NW 

Suite 700 

Washington, DC 20036 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(9 Via First Class Mail 

( ) Other: 

P-202-822-1100 

F-202-822-1111 

RESPONDENTS: 

Dash Medical Gloves, Inc., 101 8 

c/o Robert J. Sullivan 

1018 South 54h St. 

Franklin, WI 53132 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(X) Via First Class Mail 

( )Other: 
Page 7 - Certificate of Service 

Dentexxmirst Medica Infection Control 

Association 

3704C Boren Dr. 

Greensboro, NC 27407 

Medtexx Partners, Inc. 

102 Engle St. FL2 

Englewood, NJ 0763 1 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

6) Via First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

k) Via First Class Mail 

( ) Other: 

VNITED STATES INTERNATIONAL TRADE COMMISSION 

Wu blelle" D,C. 1_ 

C£RTAIN NITRILE GLOVES 

IUuMottffor 

CERTAIN NITRILE RUBBER GWVES 

NOTICE or COMMISSION DETERMINATION NOT TO RF;V1EW AIf INlTlAL 

DETERMINATION FINDING RESPONDENT MEDTEXX PARTNERS, INC. IN 

DEFAULT 

AGENCY; U,S, lD1<moti<><>lOl Trade Coouni>sionACTION: NOli«. 

SUMMARV: Notice i, ~by aiven thoI\he U,S, InternatiooaI Tndt Commission bas 

dotennin<d not to ""jew \he p<esidi", odministrlllive low judao', ("AU") initio! d<I<nninaIion 

("10'1 (Onkr N .. , ") iD "'" _ .. f<ICo:ed imo .. tiiOtion ftndiDo: ~ Medlen 

","u .. ,,- Il10, r'Medlnxj iD de/'oult, 

FOR FURTHER INFORMATION com Aer: M iobelle Wolle,,- Offie< oftbo GcctnoI 

Counsel, U,S, 1n1mwi<><>lOl Tndc Commiooion. SOO E su-..et. S.W, Washi~ D,C. 2<l436, 

I<Iephoo< (202) 701_5463, Copies ofcoo-<:ODfidenlial <b;umects filed iD COIIIIe<:Iion "ith this 

in"<Sliption art or will be available for jD>po<tion durica otl"t"ial b"g· houn (I,~S LI"- to 

5:15 p.m,) in \he ome< .. [the Sccttto!y, U,S, Imcmotiocal Trade Comntiosinn, SOO Ii S~ 

S, W .. W~ D.C, 2<l416. telephone (202) 2OS-2000. O<neral information ~ \he 

CornrniMioc may aloo be "t .. i ..... by O<" ' ,,;nl its In\emtl .... 'er ,,/WP'Mrlyrr MIl« w. The 

public ICO<Il'd [01' !hi, ~ may be viewed OIl the Commission', . lcctronk docl<t 

(EDIS)" http://tdit!!Sll£gqr Helll'ing-imI*ted _ .. art odviotd thai infonnaboc on this 

IDlltl<r can be obWne<l by ~'" the Commission', TOO Itrminal "" (202) 205-1 &10, 
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation, on July 

6,2007, based on a complaint filed by Tillotson Corporation d.b.a. Best Manufacturing Company 

(“Tillotson”). The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 

U.S.C. 0 1337) in the importation into the United States, the sale for importation, and the sale 

within the United States after importation of certain nitrile gloves by reason of infringement of 

various claims in United States Patent No. Re. 35,616. The complaint named over thirty 

respondents. On September 19,2007, the ALJ consolidated Inv. No. 337-TA-608 with Inv. No. 

337-TA-6 12. 

On April 25,2008, Tillotson filed a motion for an order to show cause and default against 

respondent Medtexx Partners, Inc. (“Medtexx”). On May 2 1,2008, the ALJ issued Order No. 85 

ordering respondent Medtexx to show cause why it should not be found in default for failing to 

respond to the complaint and notice of investigation. 

As of June 20,2008, no response to the order had been filed by respondent Medtexx and 

the ALJ issued the subject ID finding Medtexx in default. As a consequence, the ALJ found that 

Medtexx had waived its right to appear, to be served with documents, and to contest the 

allegations against it. No petitions for review of this ID were filed. 

The Commission has determined not to review the ID. 

The authority for the Commission’s determination is contained in section 337 of the 

Tariff Act of 1930, as amended (1 9 U.S.C. $ 1337), and in section 2 10.42 of the Commission’s 

Rules of Practice and Procedure (19 C.F.R. 9 210.42). 

By order of the Commission. L 

Marilyn R. AbbottSecretary to the Commission 

Issued: July 11,2008 

2 
CERTAIN NITRILE GLOVES AND 

CERTAIN NITRILE RUBBER GLOVES 

337-TA-608 and 612 

(Consolidated) 

PUBLIC CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached NOTICE OF COMMISSION 

DETERMINATION NOT TO REVIEW AN INITIAL DETERMINATION 

FINDING RESPONDENT MEDTEXX PARTNERS, INC. IN DEFAULT has been 

served by hand upon the Commission In5y@vafive +@Fey Vu Q. Bui, Esq., and the 

following parties as indicated, on 9 

a 

U.S. International Trade Commission 

500 E Street, SW 

Washington, DC 20436 

ON BEHALF OF COMPLAINANT TILLOTSON 

CORPORATION: 

Gilbert B. Kaplan, Esq. 

Jeffrey M. Telep, Esq. 

Taryn L. Koball, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, NW 

Suite 200 

Washington, DC 20006-4706 

P-202-737-0500 

F-202-626-3737 

Anthony B. Askew, Esq. 

Katrina M. Quicker, Esq. 

Jason M. Pass, Esq. 

KING & SPALDING LLP 

1 180 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-572-4600 

F-404-572-5 100 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

&a First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail (fl ia First Class Mail 

( )Other: 
Page 2 - Certificate of Service 

Gregory C. Dorris, Esq. 

Charles H. Carpenter, Esq. 

Sean P. Bamford, Esq. 

Hamilton Square 

600 Fourteenth Street, NW 

Washington, DC 20005-2004 

P-202-220-1200 

F-202-220-1665 

PEPPER HAMILTON LLP' 

William D. Belanger, Esq. 

Aaron J. Levangie, Esq. 

Michael T. Renaud, Esq. 

PEPPER HAMILTON LLP 

125 High Street 

15fh Floor, Oliver Street Tower 

Boston, MA 02 1 10-2736 

1 

P-617-204-5 100 

F-617-204-5 150 

ON BEHALF OF RESPONDENTS TOP GLOVE 

CORPORATION Bhd, LAGLOVE 0 Sdn. 

Bhd.,HARTALEGA HOLDINGS Bhd., KOSSAN 

RUBBER INDUSTRIES Bhd., Ltd., RIVERSTONE 

RESOURCES Sdn. Bhd., YTY HOLDINGS Sdn. Bhd. 'I 

PT MEDISAFE TECHNOLOGIES, JL, PT 

SHAMROCK, LATEXX PARTNERS BERHAD and 

JDA flianjin) PLASTIC RUBBER COMPANY, 

LIMITED: 

Perry R. Clark, Esq. 

Jenny N. Lee, Esq. 

Michael T. Pieja, Esq. 

KIRKLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

P-415-439-1400 

F-415-439-1500 

( ) Via Hand Delivery 

( )Other: 

( ) Via Hand Delivery 

Overnight Mail 

First Class Mail 

( )Other: 

( ) Via Hand Delivery 

vernight Mail 

( )Other: 
Page 3 - Certificate of Service 

ON BEHALF OF RESPONDENTS ANSELL 

HEALTHCARE PRODUCTS LLC, ANSELL 

PROTECTIVE PRODUCTS, INC., AND ANSELL 

JTHAILAND) LIMITED: 

Thomas B. Kenworthy, Esq. 

David W. Marston, Esq. 

Kenneth J. Davis, Esq. 

MORGAN LEWIS & BOCKIUS LLP 

170 1 Market Street 

Philadelphia, PA 19 103-292 1 

P-215-963-5000 

F-215-963-5001 

ON BEHALF OF RESPONDENT DYNAREX 

CORPORATION: 

Donald E. deKieffer, Esq. 

J. Kevin Horgan, Esq. 

Merritt R. Blakeslee, Esq. 

DeKIEFFER & HORGAN 

729 Fifteenth Street, NW 

Suite 800 

Washington, DC 20005 

P-202-783-6900 

F-202-783 -6909 

ON BEHALF OF RESPONDENT QRP 

INCORPORATED: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL, PLC 

2730 E. Broadway Boulevard, Suite 160 

Tucson, AZ 85716-5384 

P-520-326-4600 

F-520-203-0202 

( ) Via Hand Delivery 

Overnight Mail 

First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

HVia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

Overnight Mail 

First Class Mail 

( )Other: 
Page 4 - Certificate of Service 

ON BEHALF OF RESPONDENT PROTECTIVE 

INDUSTRIAL PRODUCTS, INCORPORATED: 

J. Rodgers Lunsford, 111, Esq. 

Suzannah K. Sundby, Esq. 

SMITH GAMBRELL & RUSSELL, LLP 

Promenade 11, Suite 3 100 

1230 Peachtree Street, NE 

Atlanta, GA 30309 

Elizabeth G. Borland, Esq. 0 

P-404-815-3500 

F-404-815-3509 

ON BEHALF OF RESPONDENT ADENNA, 

INCORPORATED: 

Douglas A. Frymer, Esq. 

498 1 Irwindale Avenue 

Suite 100 

Irwindale, CA 91706 

P-626-8 13-7076 

ON BEHALF OF RESPONDENTS BEIJING 

HUATENG RUBBER PLASTIC & LATEX 

PRODUCTS COMPANY, LTD.: 

Mark L. Hogge, Esq. 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

GREENBERG TRAURIG LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-33 1-3 100 

F-202-33 1-3 10 1 

Brad Bertoglio, Esq. 

WOOD PHILLIPS 

500 West Madison Street 

Suite 3800 

Chicago, IL 60661-2562 

P-3 12-876-2105 

F-3 12-876-2020 

( ) Via Hand Delivery 

Overnight Mail 

First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Wia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

-Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(qia First Class Mail 

( )Other: 
Page 5 - Certificate of Service 

ON BEHALF OF RESPONDENT TRONEX 

INTERNATIONAL, INCORPORATED: 

Maureen F. Browne, Esq. 

Jenny L. Workman, Esq. 

HELLER EHRMAN LLP 

17 17 Rhode Island Avenue, NW 

Washington, DC 20036 

P-202-912-2000 

F-202-912-2020 

ON BEHALF OF RESPONDENT LIBERTY GLOVE, 

INCORPORATED: 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

Mark L. Hogge, Esq. 

GREENBERG TRAURIG, LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-33 1-3 100 I 

F-202-331-3101 

ON BEHALF OF RESPONDENTS CARDINAL 

HEALTH, INC., CARDINAL HEALTH 200, INC., AND 

CARDINAL HEALTH MALAYSIA 211 SDN BHD: 

Paul F. Brinkman, Esq. 

Jeffrey Schwartz, Esq. 

ALSTON & BIRD LLP 

950 F Street, NW 

Washington, DC 20004 

P-202-756-3300 

F-202-756-3333 

Michael S. Connor, Esq. 

Jessica J. Sibley, Esq. 

ALSTON & BIRD LLP 

101 South Tyron Street, Suite 4000 

Charlotte, NC 28280 

P-704-444- 1000 

F-704-444-1111 

( ) (r Via Hand Delivery 

Overnight Mail 

( Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Yf7i;ia. First Class Mail 

( )Other: 

( ) Via Hand Delivery 

Overnight Mail 

ia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

Overnight Mail 

ia First Class Mail 

( )Other: 
Page 6 - Certificate of Service 

Robert M. Mitchell, Esq. 

Angela Payne James, Esq. 

Elizabeth Kemmerer Haynes, Esq. 

ALSTON & BIRD LLP 

1201 West Peachtree Street 

Atlanta, GA 30309-3424 

P-404-88 1-7000 

F-404-88 1-7777 

ON BEHALF OF RESPONDENTS HENRY SCHEIN, 

INC. AND HSi GLOVES, INC.: 

Scott M. Daniels, Esq. 

Ken-Ichi Hattori, Esq. 

Ryan B.Chirnomas, Esq. 

WESTERMAN, HATTORI, DANIELS 

1250 Connecticut Avenue, NW - Suite 700 

Washington, DC 20036 

& ADRIAN, LLP 

P-202-822-1100 

F-202-822-1111 

( ) Via Hand Delivery 

()$dvernight Mail 

( ia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

Overnight Mail 

First-class Mail 

( )Other: 

ON BEHALF OF RESPONDENT SMART GLOVE 

HOLDINGS Sdn. Bhd., 

Scott M. Daniels, Esq. 

Ken-Ichi Hattori, Esq. 

Ryan B. Chirnomas, Esq. 

WESTERMAN, HATTORI, DANIELS & ADRIAN 

LLP 

1250 Connecticut Avenue NW 

Suite 700 

Washington, DC 20036 

( ) Via Hand Delivery 

( ) Via Overnight Mail d ia First Class Mail 

( )Other: 

P-202-822- 1 100 

F-202-822-1111 

RESPONDENTS: 

Dash Medical Gloves, Inc., 101 8 

c/o Robert J. Sullivan 

101 8 South 54' St. 

Franklin, WI 53132 

( ) Via Hand Delivery 

Overnight Mail 

First Class Mail 

( )Other: 
Page 7 - Certificate of Service 

DentexxEirst Medica Infection Control 

Association 

3704C Boren Dr. 

Greensboro, NC 27407 

Medtexx Partners, Inc. 

102 Engle St. FL2 

Englewood, NJ 0763 1 

( ) Via Hand Delivery 

( ) Via Overnight Mail (fi First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail WT ia First Class Mail 

( )Other: 
Page 8 - Certificate of Service 
UNIT'-D ST ATF..'l INn;RN"ATIOI'IAl TRAIlI! COMM ISS ION" W."" ....... D.C. 

CERTAIN" I'IlTRlLE GLOVES 

I. 'be M.uer o' 

, ....... '10. No. ll7_TA-6I Z 

CIRTAIl'I NITRILE RUBBER GLOVES 

NOTICE OF COM!IUSSION DETERMINATION NOTTO REVlF-W AN INITIAL 

DETERMINATION rr:',IING RESf'ONDENT VEE LEE CORJ'OAATION BHD. IN 

OF-FAULT 

ACTIO : NOli«. 

SUMMARY' Noo.:. is hcrcb-j ,;""" ......... U.s. , ...... .. .-. Trodo 0>nmI00.,., .... "' ....... i.0c4 ... ., <e"iow .... ptnldMa __ i"" liw Jo..oIIo:', ("AU; .. mol . """"otion 

('1[)") (Ordoor /'10. 61) in ..... bo,,_ .. ta.n«<I inv<>oigao"" find ........... 1: ... Y .. Lee 

Coo"", .. .,., BIId. ("Y .. Leo") in ""WilL 

FOR FURTHER INfORMATION CONY A~ Micholl. W ....... om... of ..... 00 ..... , 

Counod. U.s. ,-,-T ...... c.onom...,.., 500 E Slim. s.w" Woshinpxr. [).C. 20436, 

RIephooI& (201) 701-54a. Copieo of.........,..,r ....... <kot...-.. filecl in """""","", ,.illl Ohi • 

.. ...oipti<.rr II'< ","';11 too: •• .u lotol< for",-ion _I o/f"'ioIbwin<>o ........ (1:45 '.m. ., 5:1 5 PJIl.) in .... ocr"", of .... Soc~. U.s. 1"'""'"'"-1 Tnde CMn ..... 5O(l E St-. 

S.W. W''''inp:oo'o. D.C. 2001>6, «-iophoo .. (2~2) 2(1S..2OQ(). ~ infonnolion """""""" .... 

CorrorliIsion may .1"" "" _ined by -"'s its In __ at Nw1a.- "'1Ir "'Y Tho 

po.obIio "'""'" r .. Oh" ",>'Uiption "'-Y boo ..... "" on .... C< .... , ,;.,.. •• < ........ , .. _co 

(WIS) at 1rtIp:lI<dU."'I~. l-karina: in ......... pen<JIlIore odYised ..... infonnolion Oft Oh" 

....... ..., to. __ by <Ofof>c<1q .... Coonn<_', 1UD ",""",,,Ion (202) 2OS. 1"O. 
SUPPLEMENTARY INFORMATION: The Commission instituted Inv. No. 337-TA-608 on 

July 6,2007, based on a complaint filed by Tillotson Corporation d.b.a. Best Manufacturing 

Company (“Tillotson”). The complaint alleges violations of section 337 of the Tariff Act of 

1930 (1 9 U.S.C. 6 1337) in the importation into the United States, the sale for importation, and 

the sale within the United States after importation of certain nitrile gloves by reason of 

infringement of various claims in United States Patent No. Re. 35,616. The complaint named 

over thirty respondents. On September 19,2007, the ALJ consolidated Inv. No. 337-TA-608 

with Inv. No. 337-TA-612. 

On August 22,2007, Tillotson filed a motion for an order to show cause and default 

against six respondents: Basic Medical Industries, Inc.; Blovco (M) Bhd.; Ideal Healthcare 

Group Co. Ltd.; Seal Polymer Industries Bhd. (“Seal Polymer”); Supermax Corporation Bhd. 

(“Supermax”); and Yee Lee. On September 10,2007, the ALJ issued Order No. 17 ordering 

these respondents to show cause why they should not be found in default for failing to respond to 

the complaint and notice of investigation. 

Respondents Seal Polymer, Supermax, and Yee Lee all filed responses requesting more 

time to respond to the complaint. Yee Lee subsequently submitted two more requests for 

additional time. On November 27,2008, Tillotson filed a motion for a finding of default against 

Yee Lee. On February 21,2008, the ALJ issued another order to show cause why Yee Lee 

should not be held in default for failing to respond to the complaint and notice of investigation. 

No responses were received. On March 10,2008, the ALJ issued the subject ID finding Yee Lee 

in default. The ALJ also found that Yee Lee had waived its right to appear, to be served with 

documents, and to contest the allegations against it. No petitions for review of this ID were 

filed. 

The Commission has determined not to review the ID. 

The authority for the Commission’s determination is contained in section 337 of the 

Tariff Act of 1930, as amended (19 U.S.C. 6 1337), and in section 210.42 of the Commission’s 

Rules of Practice and Procedure (1 9 C.F.R. 6 2 10.42). 

By order of the Commission. . 

Marilyn Mbott 

Secretary to the Commission 

Issued: March 28,2008 
CERTAIN NITRILE GLOVES AND 

CERTAIN NITRILE RUBBER GLOVES 

337-TA-608 and 612 

(Consolidated) 

PUBLIC CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached NOTICE OF COMMISSION 

DETERMINATION NOT TO REVIEW AN INITIAL DETERMINATION 

FINDING RESPONDENT YEE LEE CORPORATION BHD. IN DEFAULT has 

been served by hand upon the Commission Investigative Attorney Vu Q. Bui, Esq., and 

the following parties as indicated, on March 28, 2008 

U.S. International Trade Co&ission 

500 E Street, SW 

Washington, DC 20436 

ON BEHALF OF COMPLAINANT TILLOTSON 

CORPORATION: 

Gilbert B. Kaplan, Esq. 

Jeffrey M. Telep, Esq. 

Taryn L. Koball, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, NW 

Suite 200 

Washington, DC 20006-4706 

P-202-737-0500 

F-202-626-3737 

Anthony B. Askew, Esq. 

Katrina M. Quicker, Esq. 

Jason M. Pass, Esq. 

KING & SPALDING LLP 

1 180 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-572-4600 

F-404-572-5 100 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

W Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 8 Ft;rst Class Mail 
Page 2 - Certificate of Service 

Gregory C. Dorris, Esq. 

Charles H. Carpenter, Esq. 

Sean P. Bamford, Esq. 

PEPPER HAMILTON LLP 

Hamilton Square 

600 Fourteenth Street, NW 

Washington, DC 20005-2004 

P-202-220- 1200 

F-202-220-1665 

William D. Belanger, Esq. 

Aaron J. Levangie, Esq. 

PEPPER HAMILTON LLP 

Suite 1010 

101 Federal Street 

Boston, MA 02 1 10-1 8 17 

P-617-956-4350 

F-617-956-435 1 

ON BEHALF OF RESPONDENTS TOP GLOVE 

CORPORATION Bhd, LAGLOVE (M) Sdn. 

Bhd.,HARTALEGA HOLDINGS Bhd., KOSSAN 

RUBBER INDUSTRIES Bhd., Ltd., RIVERSTONE 

RESOURCES Sdn. Bhd., YTY HOLDINGS Sdn. Bhd. 

PT MEDISAFE TECHNOLOGIES, JL, PT 

SHAMROCK, LATEXX PARTNERS BERHAD and 

JDA (Tianiin) PLASTIC RUBBER COMPANY, 

LIMITED: 

Perry R. Clark, Esq. 

Jenny N. Lee, Esq. 

Michael T. Pieja, Esq. 

KIRKLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

P-415-439-1400 

F-415-439-1500 

( ) Via Hand Delivery 

( ) Via Overnight Mail E :;rst Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

$?Q Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail (a Via First Class Mail 

( )Other: 
Page 3 - Certificate of Service 

ON BEHALF OF RESPONDENTS ANSELL 

HEALTHCARE PRODUCTS LLC, ANSELL 

PROTECTIVE PRODUCTS, INC., AND ANSELL 

(THAILAND) LIMITED: 

Thomas B. Kenworthy, Esq. 

David W. Marston, Esq. 

Kenneth J. Davis, Esq. 

MORGAN LEWIS & BOCKIUS LLP 

1701 Market Street 

Philadelphia, PA 19 103-292 1 

P-215-963-5000 

F-2 15-963-5001 

ON BEHALF OF RESPONDENT DYNAREX 

CORPORATION: 

Donald E. deKieffer, Esq. 

J. Kevin Horgan, Esq. 

Merritt R. Blakeslee, Esq. 

DeKIEFFER & HORGAN 

729 Fifteenth Street, NW 

Suite 800 

Washington, DC 20005 

P-202-783-6900 

F-202-783-6909 

ON BEHALF OF RESPONDENT DARBY GROUP 

COMPANIES: 

Michael S. French, Esq. 

Shanon J. McGinnis, Esq. 

Sara-Ne11 H. Walsh, Esq. 

WARGO & FRENCH 

1 170 Peachtree Street NE 

Suite 2020 

Atlanta, GA 30309 

P-404-853-1500 

F-404-853-1501 

( ) Via Hand Delivery 

( ) Via Overnight Mail Rt;F Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

p) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail ti :;rst Class Mail 
Page 4 - Certificate of Service 

ON BEHALF OF RESPONDENT QRP 

INCORPORATED: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL, PLC 

2730 E. Broadway Boulevard, Suite 160 

Tucson, AZ 85716-5384 

P-520-326-4600 

F-520-203-0202 

ON BEHALF OF RESPONDENT PROTECTIVE 

INDUSTRIAL PRODUCTS, INCORPORATED: 

J. Rodgers Lunsford, 111, Esq. 

Elizabeth G. Borland, Esq. 

Suzannah K. Sundby, Esq. 

SMITH GAMBRELL & RUSSELL, LLP 

Promenade 11, Suite 3 100 

1230 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-815-3500 

F-404-815-3509 

ON BEHALF OF RESPONDENT ADENNA, 

INCORPORATED: 

Douglas A. Frymer, Esq. 

498 1 Irwindale Avenue 

Suite 100 

Irwindale, CA 9 1706 

P-626-813-7076 

ON BEHALF OF RESPONDENTS BEIJING 

HUATENG RUBBER PLASTIC & LATEX 

PRODUCTS COMPANY, LTD.: 

Mark L. Hogge, Esq. 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

GREENBERG TRAURIG LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

( ) Via Hand Delivery 

( ) Via Overnight Mail p; Vi~irst Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail t; E~irst Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail fi Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 8 ;;rst Class Mail 
Page 5 - Certificate of Service 

P-202-33 1-3 100 

F-202-33 1-3 101 

Brad Bertoglio, Esq. 

WOOD PHILLIPS 

500 West Madison Street 

Suite 3800 

Chicago, IL 60661 -2562 

P-3 12-876-2 105 

F-3 12-876-2020 

ON BEHALF OF RESPONDENT TRONEX 

INTERNATIONAL, INCORPORATED: 

Maureen F. Browne, Esq. 

Jenny L. Workman, Esq. 

HELLER EHRMAN LLP 

17 17 mode Island Avenue, NW 

Washington, DC 20036 

P-202-9 12-2000 

F-202-9 12-2020 

ON BEHALF OF RESPONDENT LIBERTY GLOVE, 

INCORPORATED: 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

Mark L. Hogge, Esq. 

GREENBERG TRAUFUG, LLP 

2101 L Street, NW 

Suite 1000 

Washington, DC 20037 

P-202-331-3 100 

F-202-33 1-3 10 1 

ON BEHALF OF RESPONDENTS CARDINAL 

HEALTH, INC., CARDINAL HEALTH 200, INC., AND 

CARDINAL HEALTH MALAYSIA 211 SDN BHD: 

Paul F. Brinkman, Esq. 

Jeffrey Schwartz, Esq. 

ALSTON & BIRD LLP 

950 F Street, NW 

Washington, DC 20004 

P-202-756-3300 

( ) Via Hand Delivery 

( ) Via Overnight Mail 1/”3 Vidirst Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail Viirst Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

($) Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail E ;i,”,i”’ Class Mail 
Page 6 - Certificate of Service 

F-202-756-3333 

Michael S. Connor, Esq. 

Don W. Anthony, Esq. 

Jessica J. Sibley, Esq. 

ALSTON & BIRD LLP 

101 South Tyron Street, Suite 4000 

Charlotte, NC 28280 

P-704-444-1000 

F-704-444- 1 1 1 1 

Robert M. Mitchell, Esq. 

Angela Payne James, Esq. 

Elizabeth Kemmerer Haynes, Esq. 

ALSTON & BIRD LLP 

1201 West Peachtree Street 

Atlanta, GA 30309-3424 

P-404-88 1-7000 

F-404-881-7777 

ON BEHALF OF RESPONDENTS HENRY SCHEIN, 

INC. AND HSi GLOVES, INC.: 

Scott M. Daniels, Esq. 

Ken-Ichi Hattori, Esq. 

Ryan B.Chirnomas, Esq. 

WESTERMAN, HATTORI, DANIELS 

& ADRIAN, LLP 

1250 Connecticut Avenue, NW - Suite 700 

Washington, DC 20036 

P-202-822- 1 100 

F-202-822-1111 

( ) Via Hand Delivery 

( ) Via Overnight Mail W;i. Class Mail 

( ) Via Hand Delivery 

( ) Via Ovemight Mail 

(H Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

pW Via First Class Mail 

( ) Other: 

ON BEHALF OF RESPONDENT SMART GLOVE 

HOLDINGS Sdn. Bhd., 

Scott M. Daniels, Esq. 

Ken-Ich Hattori, Esq. 

Ryan B. Chirnomas, Esq. 

WESTERMAN, HATTORI, DANIELS & ADRIAN 

LLP 

1250 Connecticut Avenue NW 

Suite 700 

Washington, DC 20036 

( ) Via Hand Delivery 

( ) Via Overnight Mail fl Vh,",i" Class Mail 

P-202-822- 1 100 
Page 7 - Certificate of Service 

F-202-822-1111 

RESPONDENTS: 

Dash Medical Gloves, Inc., 1018 

c/o Robert J. Sullivan 

1018 South 54th St. 

Franklin, WI 53132 

Dentexflirst Medica Infection Control 

Association 

3704C Boren Dr. 

Greensboro, NC 27407 

Medtexx Partners, Inc. 

102 Engle St. FL2 

Englewood, NJ 0763 1 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

Via First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 8 41$rst Class Mail 

( ) Via Hand Delivery 

( ) Via Overnight Mail e gik~rst Class Mail 

UNITED STATES 1Nn:ItNATIONAL TRADE COMMISSION 

Wullo_D.C. 

CEIITAIN/'IITRIU GI.OVI:S 

I. I •• M . .... 01 I .. ·.. tipolo. No. 337_TA-liU 

CERTAL~ NITRILE RIIBBER GLOVI:S 

NOTICE or CO .... M ISSION DETERMINATION NOT TO JU:VIEW ANINlnAL 

DETtKlllINATION FINDING THRf.t R£SPOND£NTS lI'I DEFAUI.T 

AGENCY: u.s. inlernaIiooal T ...... Conuni"""". 

SUMMARY: Notice i, benby Ii-_ .... u.s .... ..-ional T_ Commi"""" 11M 

<k<ennined _ to review .... ~ odminiotnti"" _ iu4a:e', ("AU") ;";tiol deIernlinati .. 

("IIY') (Ordeo No. 22) r~ u.........,....,.... in do::fauJl 

SUPPLEMENTARY INFORMATION: Tho Conuninion iIwtiIul«ll ... No. 337_TA4)8 .. 

loIy~, 2007, buod 011 . '"""1' .... flied by n_ Coopototi .. d. .L Beat ......... faeturiq 
Company (“Tillotson”). The complaint alleges violations of section 337 of the Tariff Act of 

1930 (19 U.S.C. 0 1337) in the importation into the United States, the sale for importation, and 

the sale within the United States after importation of certain nitrile gloves by reason of 

infringement of various claims in United States Patent No. Re. 35,616. The complaint named 

over thirty respondents. On September 19,2007, the ALJ consolidated Inv. No. 337-TA-608 

with Inv. No. 337-TA-612 

On August 22,2007, Tillotson filed a motion for an order to show cause and default 

against six respondents: Basic Medical Industries, Inc. (“Basic Medical”); Glovco (M) Bhd. 

(“Glovco”); Ideal Healthcare Group Co. Ltd. (“Ideal Healthcare”); Seal Polymer Industries Bhd. 

(“Seal Polymer”); Supermax Corporation Bhd. (“Supermax”); and Yee Lee Corporation Bhd. 

(“Yee Lee”). On September 10,2007, the ALJ issued Order No. 17 ordering these respondents 

to show why they should not be found in default for failing to respond to the complaint and 

notice of investigation. 

Respondents Seal Polymer, Supermax, and Yee Lee all filed responses requesting more 

time to respond to the complaint. The ALJ granted these requests. However, the ALJ found 

pursuant to Commission Rule 210.16, 19 U.S.C. 0 210.16, that Basic Medical, Glovco, and Ideal 

Healthcare were in default because they failed to respond to the complaint and notice of 

investigation and failed to respond to the ALJ’s order to show cause why they should not be 

found in default. The ALJ also found that they have waived their rights to appear, be served with 

documents, and to contest the allegations against them. No petitions for review of this ID were 

filed. The Commission has determined not to review the ID. 

The authority for the Commission’s determination is contained in section 337 of the 

Tariff Act of 1930, as amended (19 U.S.C. 8 1337), and in section 210.42 of the Commission’s 

Rules of Practice and Procedure (19 C.F.R. 0 210.42). - 

By order of the Commission. 

Acting Secretary to the Commission 

Issued: October 15,2007 

2 
CERTAIN NITRILE RUBBER GLOVES 337-TA-608 and 

612 

(Consolidated) 

CERTIFICATE OF SERVICE 

I, Marilyn R. Abbott, hereby certify that the attached NOTICE OF COMMISSION 

DETERMINATION NOT TO REVIEW AN INITIAL DETERMINATION 

FINDING THREE RESPONDENTS IN DEFAULT has been served by hand upon 

the Commission Investigative Attorney Vu Q. Bui, Esq., and the following parties as 

indicated, on nrtnher 17, 7nn7 

Id7d k)d &lf &$ R.’hbbott, Secretary 

U.S. International Trade Commission 

500 E Street, SW 

Washington, DC 20436 

ON BEHALF OF COMPLAINANT TILLOTSON 

CORPORATION: 

Gilbert B. Kaplan, Esq. 

Jeffrey M. Telep, Esq. 

Taryn L. Koball, Esq. 

KING & SPALDING LLP 

1700 Pennsylvania Avenue, NW 

Suite 200 

Washington, DC 20006-4706 

P-202-737-0500 

F-202-626-3737 

Anthony B. Askew, Esq. 

Katrina M. Quicker, Esq. 

Jason M. Pass, Esq. 

KING & SPALDING LLP 

1 180 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-572-4600 

F-404-572-5 100 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(&a First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

( @6ia First Class Mail 

( )Other: 
Page 2 - Certificate of Service 

Gregory C. Dorris, Esq. 

Charles H. Carpenter, Esq. 

Sean P. Bamford, Esq. 

PEPPER HAMILTON LLP 

Hamilton Square 

600 Fourteenth Street, NW 

Washington, DC 20005-2004 

P-202-220- 1200 

F-202-220-1665 

William D. Belanger, Esq. 

Aaron J. Levangie, Esq. 

PEPPER HAMILTON LLP 

Suite 1010 

101 Federal Street 

Boston, MA 02110-1817 

P-6 17-956-4350 

F-617-956-435 1 

ON BEHALF OF RESPONDENTS TOP GLOVE 

CORPORATION Bhd, LAGLOVE (M) Sdn. 

Bhd.,HARTALEGA HOLDINGS Bhd., KOSSAN 

RUBBER INDUSTRIES Bhd., Ltd., RIVERSTONE 

RESOURCES Sdn. Bhd., YTY HOLDINGS Sdn. Bhd. 

PT MEDISAFE TECHNOLOGIES, JL, PT 

SHAMROCK AND LATEXX PARTNERS BERHAD: 

Perry R. Clark, Esq. 

Jenny N. Lee, Esq. 

Michael T. Pieja, Esq. 

KIRKLAND & ELLIS LLP 

555 California Street 

San Francisco, CA 94104-1501 

P-415-439-1400 

F-415-439-1500 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(Wia First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(ryfria First Class Mail 

( ) Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

( yfria First Class Mail 

( )Other: 
Page 3 - Certificate of Service 

ON BEHALF OF RESPONDENT ANSELL LIMITED: 

Thomas B. Kenworthy, Esq. 

David W. Marston, Esq. 

MORGAN LEWIS & BOCKIUS LLP 

1701 Market Street 

Philadelphia, PA 19 103-292 1 

P-215-963-5000 

F-215-963-5001 

ON BEHALF OF RESPONDENT DYNAREX 

CORPORATION: 

Donald E. deKieffer, Esq. 

J. Kevin Horgan, Esq. 

Merritt R. Blakeslee, Esq. 

DeKIEFFER & HORGAN 

729 Fifteenth Street, NW 

Suite 800 

Washington, DC 20005 

P-202-783-6900 

F-202-783-6909 

ON BEHALF OF RESPONDENT DARBY GROUP 

COMPANIES: 

Michael S. French, Esq. 

Shanon J. McGinnis, Esq. 

Sara-Ne11 H. Walsh, Esq. 

WARGO & FRENCH 

1 170 Peachtree Street NE 

Suite 2020 

Atlanta, GA 30309 

P-404-853-1500 

F-404-853-1501 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(wia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

( ) Via Overnight Mail 

(gia First Class Mail 

( )Other: 

( ) Via Hand Delivery 

(?a Overnight Mail 

( Via First Class Mail 

( ) Other: 
Page 4 - Certificate of Service 

ON BEHALF OF RESPONDENT QRP 

INCORPORATED: 

Daniel J. Quigley, Esq. 

QUIGLEY & WHITEHILL, PLC 

2730 E. Broadway Boulevard, Suite 160 

Tucson, AZ 85716-5384 

P-520-326-4600 

F-520-203-0202 

ON BEHALF OF RESPONDENT DELTA MEDICAL 

SYSTEMS, INCORPORATED.: 

Michael J. Powell, Esq. 

BAKER DONELSON BEARMAN CALDWELL & 

BERKOWITZ, P.C. 

6 Concourse Parkway, Suite 3 100 

Atlanta, GA 30328 

P-678-406-8700 

F-678-406-8701 

Lea H. Speed, Esq. 

BAKER DONELSON BEARMAN CALDWELL & 

BERKOWITZ, P.C. 

165 Madison Avenue, Suite 2000 

Memphis, TN 38103 

P-901-526-2000 

F-901-577-2303 

ON BEHALF OF RESPONDENT PROTECTIVE 

INDUSTRIAL PRODUCTS, INCORPORATED.: 

J. Rodgers Lunsford, 111, Esq. 

Elizabeth G. Borland, Esq. 

SMITH GAMBRELL & RUSSELL, LLP 

Promenade 11, Suite 3 100 

1230 Peachtree Street, NE 

Atlanta, GA 30309 

P-404-815-3500 

F-404-815-3509 

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Page 5 - Certificate of Service 

ON BEHALF OF RESPONDENT ADENNA, 

INCORPORATED: 

Douglas A. Frymer, Esq. 

498 1 Irwindale Avenue 

Suite 100 

Irwindale, CA 9 1706 

P-626-813-7076 

ON BEHALF OF RESPONDENTS BEIJING 

HUATENG RUBBER PLASTIC & LATEX 

PRODUCTS COMPANY, LTD.: 

Mark L. Hogge, Esq. 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

GREENBERG TRAURIG LLP 

800 Connecticut Avenue, NW 

Suite 500 

Washington, DC 20006 

P-202-33 1-3 100 

F-202-331-3101 

Brad Bertoglio, Esq. 

WOOD PHILLIPS 

500 West Madison Street 

Suite 3800 

Chicago, IL 60661 -2562 

P-3 12-876-2105 

F-3 12-876-2020 

ON BEHALF OF RESPONDENT TRONEX 

INTERNATIONAL, INCORPORATED: 

Maureen F. Browne, Esq. 

Jenny L. Workman, Esq. 

HELLER EHRMAN LLP 

17 17 Rhode Island Avenue, NW 

Washington, DC 20036 

P-202-9 12-2000 

F-202-912-2020 

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Page 6 - Certificate of Service 

ON BEHALF OF RESPONDENT LIBERTY GLOVE, 

INCORPORATED: 

Rosa S. Jeong, Esq. 

Philippe M. Bruno, Esq. 

Mark L. Hogge, Esq. 

GREENBERG TRAURIG, LLP 

800 Connecticut Avenue, NW 

Suite 500 

Washington, DC 20006 

P-202-33 1-3 100 

F-202-331-3101 

ON BEHALF OF CARDINAL HEALTH, INC., 

CARDINAL HEALTH 200, INC., AND CARDINAL 

HEALTH MALAYSIA 211 SDN BHD: 

Paul F. Brinkman, Esq. 

Jeffrey Schwartz, Esq. 

ALSTON & BIRD LLP 

950 F Street, NW 

Washington, DC 20004 

P-202-756-3300 

F-202-756-3333 

Michael S. Connor, Esq. 

Don W. Anthony, Esq. 

Jessica J. Sibley, Esq. 

ALSTON & BIRD LLP 

101 South Tyron Street, Suite 4000 

Charlotte, NC 28280 

P-704-444-1000 

F-704-444- 1 1 1 1 

Robert M. Mitchell, Esq. 

Angela Payne James, Esq. 

Elizabeth Kemmerer Haynes, Esq. 

ALSTON & BIRD LLP 

1201 West Peachtree Street 

Atlanta, GA 30309-3424 

P-404-88 1-7000 

F-404-88 1-7777 

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(iyfria First Class Mail 

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Page 7 - Certificate of Service 

ON BEHALF OF RESPONDENTS HENRY SCHEIN, 

INC. AND HSi GLOVES, INC.: 

Lawrence K. Nodine, Esq. 

Robin L. Gentry, Esq. 

J. Scott Anderson, Esq. 

NEEDLE & ROSENBERG, P.C. 

999 Peachtree Street, Suite 1000 

Atlanta, GA 30309-3915 

P-678-420-9300 

F-678-420-930 1 

ON BEHALF OF RESPONDENTS SEALPOLYMER 

INDUSTRIES AND SUPERMAX CORPORATION: 

William J. Hallihan, Esq. 

AMIN & HALLIHAN 

217 N. Jefferson Street, 1'' Floor 

Chicago, IL 60661 

P-3 12-466- 1033 

F-312-223-1515 

Todd L. Juneau, Esq. 

JUNEAU PARTNERS, PLLC 

2121 Eisenhower Avenue, Suite 200 

Alexandria, VA 223 14 

P-703-548-3569 

F-703-940- 1 142 

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ON BEHALF OF RESPONDENT SMART GLOVE 

HOLDINGS Sdn. Bhd., 

Scott M. Daniels, Esq. ( ) Via Hand Delivery 

Ken-Ichi Hattori, Esq. (ra Overnight Mail 

Ryan B. Chirnomas, Esq. ( Via First Class Mail 

WESTERMAN, HATTORI, DANIELS & ADRIAN ( )Other: 

LLP 

1250 Conn. Ave., NW 

Suite 700 

Washington, DC 20036 

P-202-822-1100 

F-202-822-1111 
Page 8 - Certificate of Service 

RESPONDENTS: 

Glovco (M) Sdn. Bhd. 

Lot 760, Jalan Haji Sirat, 

Off Jalan Meru Klang, 42100, 

Selangor D.E., Malaysia 

Ideal Healthcare Group Co., Ltd., Bldg. 18, No. 1, 

South Section of Huacheng (W) Road, 

Ningbo, China 3 1500 

JDA (Tianjin) Plastic Rubber Co., Ltd. 

No. 17 Hai Bin No. 7 Rd, 

Tianjin Port Free Trade Zone 

Tianjin, 300456, China 

Yee Lee Corporation Bhd., Lot 85 Jalan 

Portland, Tasek Industrial Estates, 3 1400 Ipoh 

Perak Dad Ridzuan, Malaysia 

Basic Medical Industries Inc. 

12390 East End Ave. 

Chino, CA 91710 

Dash Medical Gloves, Inc., 1018 

c/o Robert J. Sullivan 

1018 South 54th St. 

Franklin, WI 53132 

Dentexflirst Medica Infection Control 

Association 

3704C Boren Dr. 

Greensboro, NC 27407 

Medtexx Partners, Inc. 

102 Engle St. FL2 

Englewood, NJ 0763 1 

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( )Other: 

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($Via First Class Mail 

( )Other: 

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(+Via First Class Mail 

( )Other: 

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( )Other: 

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( )Other: