IN THE UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF NEW YORK

____________________________________

)

MEDTECH PRODUCTS INC., )

)

Plaintiff, )

)

v. )

)

RANIR, LLC and )

CVS PHARMACY, INC. )

)

Defendant. )

____________________________________)

)

MEDTECH PRODUCTS INC., )

)

Plaintiff, )

)

v. )

)

DENTEK ORAL CARE, INC., )

KELLY M. KAPLAN, )

RAY DUANE, and )

C.D.S. ASSOCIATES, INC., )

)

Defendants. )

____________________________________)

)

MEDTECH PRODUCTS INC., )

)

Plaintiff, )

)

v. )

)

POWER PRODUCTS, INC., )

d/b/a/ SPLINTEK, )

)

Defendant. )

____________________________________)

Civil Action No. 07 CV 3302 (KMK)(LMS)

ECF FILED

ORAL ARGUMENT REQUESTED

PLAINTIFF’S OBJECTION TO REPORT AND RECOMMENDATION REGARDING

DISPUTED TERMS OF CLAIM 17 OF U.S. PATENT NO. 6,830,051

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Table of Contents

Page

i

THE APPLICABLE STANDARD OF REVIEW..................................................................... 1

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

INTRODUCTION........................................................................................................................ 2

SUMMARY OF OBJECTIONS................................................................................................. 4

ARGUMENT................................................................................................................................ 4

I. The recommended definition for the term “a resin” improperly imposes the

limitation that “a resin” can only be “thermoplastic” even though the parties,

as well as their respective experts, agree that in Claim 17 “a resin” can also

be “thermosetting.”.......................................................................................................... 7

II. Even though the claim language itself is devoid of any reference to

manufacturing by injection molding or to the physical appearance of the

resulting device, the recommended definition of the term “molding over the

base” imposes manufacturing specifications and structural requirements that

improperly limit the scope of Claim 17........................................................................ 10

A. Injection Molding Limitation is Improper. .......................................................... 11

B. Structural Limitation is Improper. ....................................................................... 14

(1) The Summary is not a proper basis for imposing structural

limitations on Claim 17............................................................................ 15

(2) The Figures or illustrations in the Specification do not impose

structural limitations on Claim 17............................................................ 18

III. Although bonding methods have not previously been raised or addressed by

the parties or the Court, footnote 4 of the Report could be read to improperly

limit the invention to require that the unitary bond between the base and

preform be achieved only by one or more of the following: “heating the resin,

coating the base with a bonding agent or priming material, or texturing the

surface of the base.”....................................................................................................... 19

IV. The definition of the term “an impression preform” should properly omit the

Report’s limiting phrase “consistent with the remainder of the requirements

in Claim 17” in order to conform to the Court’s reasoning and intent as

stated on page 20 of the Report because the present construction can be read

to improperly incorporate all of the other terms of the entire Claim 17 and

their limitations, rather than the Court’s intended result of defining the

disputed term as “a thermoplastic resin which serves as an impression

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Table of Contents

(continued)

Page

ii

material” and that definition being later independently modified by the

chemical makeup as recited in subpart (b) of the claim............................................. 22

CONCLUSION .......................................................................................................................... 23

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1

Plaintiff Medtech Products, Inc. (“Medtech”) objects to the Report and Recommendation

Regarding Disputed Terms of Claim 17 of U.S. Patent No. 6,830,051 (“the ‘051 Patent”) of Lisa

Margaret Smith, Chief United States Magistrate Judge (“Magistrate Judge Smith”) (the

“Report”) (Docket No. 71) in four very narrow respects.

THE APPLICABLE STANDARD OF REVIEW

In the context of a Report and Recommendation, the Court must “make a de novo

determination ... of any portion of the magistrate judge’s disposition to which specific written

objection has been made.” Medinol Ltd. v. Guidant Corp., 500 F. Supp. 2d 345, 349 (S.D.N.Y.

2007); Pizarro v. Bartlett, 776 F. Supp. 815, 817 (S.D.N.Y. 1991); Fed. R. Civ. P. 72(b). This

standard of review applies to Reports and Recommendations related to claim construction. See,

e.g., ABP Patent Holding, LLC. v. Convergent Label Technology, Inc., 194 F.Supp.2d 1257,

1259 (M.D. Fla. 2002); Golden Voice Technology & Training, L.L.C. v. Rockwell Firstpoint

Contact Corp., 267 F. Supp. 2d 1190, 1194 (M.D. Fla. 2003).

BACKGROUND

Medtech and its predecessor-in-interest pioneered the over-the-counter sale of dental

protectors – products that are designed to prevent the harmful effects of bruxing and clenching.

Medtech sells a dental protector that is the subject of the ‘051 Patent. Medtech’s dental protector

is self-fitted without the need for a dental professional. The dental protector is generally

comprised of two main components, a base and a preform, that are unitarily bonded together. To

self-fit the device, the dental protector is immersed in water hot enough to soften the preform and

then dipped into cooler water. The device is inserted into the user’s mouth and the impression

preform is bitten into just enough to form an impression of the teeth in the impression preform as

it cools. The preform conforms to the unique configuration of tooth structure in the user’s mouth

as it rehardens. The base remains hardened and retains its original shape throughout the heating

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and cooling phases of the self-fitting process. After achieving proper fit, the user may use the

fitted dental protector on a nightly basis to prevent the detrimental effects of bruxing and

clenching.

INTRODUCTION

In its Second Amended Complaint, Medtech alleges that Defendant DenTek Oral Care,

Inc. (“DenTek”) has, inter alia, infringed the ‘051 Patent. (See generally Second Amended

Complaint, Docket No. 66). Specifically, Medtech asserts that DenTek has infringed Claim 17

of the ‘051 Patent, which claims a method for fabricating a dental protector device as follows:

A method of fabricating an interocclusal appliance for alleviation

of the adverse effects of bruxing or clenching events, the method

comprising the steps of:

a) molding and [sic] appliance base from a resin having a Vicat

softening temperature of at least 70° C and a Shore A hardness of

at least 80; and

b) molding over the base an impression preform from a resin

comprising an ethylene vinyl acetate copolymer having

approximately 30% by weight vinyl acetate.

Col. 12:47-56. Notably, it is only the method of fabrication itself that is the subject of the

asserted claim in this case, not the product that is fabricated from that method.

Medtech and DenTek initially identified thirteen terms of Claim 17 (the “terms”) for the

Court to construe, but ultimately stipulated to the definitions of all but the following five terms:

(1) “interocclusal appliance,” (2) “a resin,” (3) “molding over the base,” (4) “an impression

preform,” and (5) “having approximately 30% by weight vinyl acetate” (collectively “the

Disputed Terms”). Report, p. 8. On July 13, 2007 and July 20, 2007, Medtech and DenTek filed

claim construction statements and responses related to the Disputed Terms. (See Docket Nos.

45, 46, 49, and 50). On September 5, 2007, a claim construction hearing (the “9/5/07 Hearing”)

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was held and during which the Court heard the testimony of Medtech’s and DenTek’s respective

expert witnesses and argument from counsel. (Docket No. 52).

Magistrate Judge Smith issued the Report on October 12, 2007. The recommended

definitions for the terms “interocclusal appliance” and “having approximately 30% by weight

vinyl acetate” as set forth in the Report are in all respects correct, and Medtech urges the Court

to adopt these definitions. See Report, pp. 10, 21. Medtech, however, respectfully submits that

the Report’s definitions of “a resin,” “molding over the base” and “an impression preform” place

improper limitations on the scope of Claim 17 and/or are at odds with the language of the ‘051

Patent and the understanding that one of ordinary skill in the art would have of the ‘051 Patent.

Accordingly, Medtech respectfully requests that this Court reject the Report’s recommended

definitions for the terms “a resin,” “molding over the base,” and “impression preform,” as well as

any limitation the Report may place on the manner in which bonding of the base and preform

may be achieved1. Instead, Medtech urges this Court to adopt Medtech’s proposed definitions

for the three remaining terms in dispute – definitions which are directly supported by the

intrinsic and extrinsic evidence of record in this case – and also to clarify and rule that the Report

does not implicitly or explicitly define or limit the methods of bonding the preform to the base.

Medtech respectfully requests that the Court grant oral argument on a date and at a time

designated by the Court on Medtech’s Objection to the Report and Recommendation Regarding

Disputed Terms of Claim 17 of U.S. Patent No. 6,830,051.

1 Report, pg. 17, fn. 4.

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SUMMARY OF OBJECTIONS

1. The recommended definition for the term “a resin” improperly imposes the

limitation that “a resin” can only be “thermoplastic” even though the parties, as well as their

respective experts, agree that in Claim 17 “a resin” can also be “thermosetting.”

2. Even though the claim language itself is devoid of any reference to manufacturing

by injection molding or to the physical appearance of a resulting device, the recommended

definition of the term “molding over the base” imposes manufacturing specifications and

structural requirements that improperly limit the scope of Claim 17.

3. Although bonding methods have not previously been raised or addressed by the

parties or the Court and no limitation exists in Claim 17, footnote 4 of the Report could be read

to limit improperly the invention to require that the unitary bond between the base and preform

be achieved only by one or more of the following: “heating the resin, coating the base with a

bonding agent or priming material, or texturing the surface of the base.”

4. The definition of the term “an impression preform” should properly omit the

Report’s limiting phrase “consistent with the remainder of the requirements in Claim 17” in

order to conform to the Court’s reasoning and intent as stated on Page 20 of the Report because

the present construction can be read to improperly incorporate all of the other terms of the entire

Claim 17 and their limitations, rather than the Court’s intended result of defining the disputed

term as “a thermoplastic resin which serves as an impression material” and that definition being

later independently modified by the chemical makeup as recited in subpart (b) of the claim.

ARGUMENT

“It is a ‘bedrock principle’ of patent law that the claims of a patent define the invention to

which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312

(Fed. Cir. 2005) (en banc) (citations omitted). Accordingly, “claim construction analysis must

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begin and remain centered on the claim language itself, for that is the language that the patentee

has chosen to ‘particularly point[] out and distinctly claim[] the subject matter which the patentee

regards as his invention.” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d

1111, 1116 (Fed. Cir. 2004) (quoting Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d

1323, 1331 (Fed. Cir. 2001)). The role of claim construction “is neither to limit nor to broaden

the claim, but to define, as a matter of law, the invention that has been patented.” Netword, LLC

v. Central Corp., 242 F.3d 1347, 1352 (Fed. Cir. 2005).

The words of a claim “are generally given their ordinary and customary meaning.”

Phillips, 415 F.3d at 1313. It is well established that the ordinary and customary meaning of a

claim term is the meaning that the term would have to a person of ordinary skill in the relevant

art at the time of the invention, i.e., as of the effective filing date of the patent application. Id.

Unless otherwise compelled, a court should give full effect to the ordinary meaning of claim

terms even if the terms are broad. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d

985, 989 (Fed. Cir. 1999).

The claims, however, are not construed in a vacuum. Toro Co. v. White Consolidated

Indus., Inc., 199 F.3d 1295, 1301 (Fed. Cir. 1999). If the ordinary meaning of claim language as

understood by a person of skill in the relevant art is not readily apparent, a court may determine

the ordinary and customary meaning of the term by looking beyond the claims to the

specification of the patent, the prosecution history or the patent, and prior art references cited

during the prosecution history of the patent. Phillips, 415 F.3d at 1312. In an appropriate case,

the specification often is the single best guide to the meaning of a disputed term. Phillips, 1303

at 1312.

However, there is a “thin line” between reading a claim in light of the specification and

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the well-established principle that the specification cannot import limitations into the claims.

Comark Comm., Inc. v. Harris Corp., 156 F.3d 1182, 1186-87 (Fed. Cir. 1998). If a claim term

is readily apparent to one with ordinary skill in the relevant art, then consideration of the

specification and the prosecution history is typically limited to confirming whether the ordinary

meaning applies or whether the patentee intended to deviate from this meaning. Interactive Gift

Express, 256 F.3d at 1331. The Federal Circuit has repeatedly recognized that there is a

difference between construing a term appearing in a claim, and adding a limitation that is not

there in the first place. The former is permissible; the latter is not. See, e.g., Interactive Gift

Express, 256 F.3d at 1331-32 (citations omitted); Burke, Inc. v. Bruno Indep. Living Aids, Inc.,

183 F.3d 1334, 1340 (Fed. Cir. 1999).

It is particularly inappropriate to import attributes of the preferred embodiment portion of

the specification into the claims as limitations. Innova/Pure Water, 381 F.3d at 1117.

“References to a preferred embodiment, such as those often present in a specification, are not

claim limitations.” Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d 855, 865 (Fed. Cir.

1988). “This court has cautioned against limiting the claimed invention to preferred

embodiments or specific examples in the specification.” Texas Instruments, Inc. v. United States

Int’l Trade Comm’n, 805 F.2d 1558, 1563 (Fed. Cir. 1986).

Definitions that arise from extrinsic evidence, such as dictionaries, also may be used but

are limited by the intrinsic evidence. Phillips, 415 F.3d at 1322. Subsequent Federal Circuit

decisions have interpreted Phillips to mean that dictionaries may be used in one of two

situations. First, dictionaries may be used to confirm the definition supported by the intrinsic

evidence. Nystrom v. Trex Co., Inc., 424 F.3d 1136, 1145-46 (Fed. Cir. 2005). Second, it is

appropriate to look to dictionaries, including scientific and technical dictionaries, to construe the

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ordinary and customary meaning of a word when there is “no suggestion in the intrinsic

evidence” that defines a term. Atofina v. Great Lakes Chemical Corp., 78 USPQ2d 1417, 1421

(Fed. Cir. March 23, 2006).

I. The recommended definition for the term “a resin” improperly imposes the

limitation that “a resin” can only be “thermoplastic” even though the parties, as

well as their respective experts, agree that in Claim 17 “a resin” can also be

“thermosetting.”

The Report’s definition of “a resin” improperly limits the term to “a thermoplastic solid

or semi-solid substance” when it should include “thermosetting or thermoplastic.” In the Report,

it is recommended that the term “a resin” in Claim 17 should be defined as “a thermoplastic solid

or semi-solid substance.” Report, p. 12 (emphasis added). The Report bases this conclusion on

the reasoning that “thermoplastic” is “used either in place of or to modify the word ‘resin’

numerous times throughout the patent and there is no indication anywhere in the patent that the

invention can be created with something other than a thermoplastic resin.” Report, pp. 13-14.

Medtech respectfully submits that the recommended definition is too narrow and should instead

be “a thermosetting2or thermoplastic3solid or semi-solid substance” in light of the intended

functionality of the invention as is described and claimed in the patent as well as is understood

by those of ordinary skill in the art.

Notably, Medtech and DenTek agree that in Claim 17, the term “a resin” should include

thermosetting and thermoplastic materials. Report, p. 11. For the purposes of claim

construction, the parties, instead, disputed only whether the term “a resin” should be further

2 As the Report acknowledges in footnote 3, “thermosetting” is defined as “[r]elating to a compound that softens

when initially heated, but hardens permanently once it is cooled . . . .” This is the characteristic exhibited by the

base of the device which softens during manufacturing but hardens thereafter.

3 The Report defines “thermoplastic” as “of or relating to a compound that can be repeatedly made soft and hard

through heating and cooling . . . .” This is the characteristic exhibited by the preform and, in certain circumstances

as are described in footnote 5 herein below, may also be exhibited by the base of the device.

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limited by the classifications of “organic,” “natural,” and “synthetic.” The Court in its Report

properly declined to include the limitations of “organic,” “natural,” or “synthetic” in its

definition of “a resin.” Accordingly, Medtech’s objection is directed only to the Report’s

exclusion of “thermosetting” from the construction of the term “a resin” and not the

recommended definition in its entirety.

Claim 17 of the ‘051 Patent uses the term “resin” as a general term to designate two

separate resin materials: the resin material used to fabricate the base in subpart (a) of the claim

and the resin material used to fabricate the impression preform in subpart (b) of the claim. Claim

17 expressly dictates that the resin material in subpart (a) must have different chemical and

physical properties from those of the resin material in subpart (b). Specifically, the resin used for

the base described in subpart (a) must have a Vicat softening temperature and a Shore A

hardness that are higher than those of the preform described in subpart (b) in order for the device

to function as intended during the self-fitting process. The patent recites that initially the device

(base and preform) is in a hardened state. When the device (base and preform) is heated in

water, the impression preform softens but the base remains hardened. As the preform cools, it

rehardens to encase the teeth with which it contacts. The base remains hardened during the

cooling phase. If reheated, the preform will again soften and reconform to the shape of the teeth

then being encased. Conversely, again the base remains hardened in its original shape and will

not deform. This distinction in the attributes of the base and preform is paramount to the

invention and dictates that the general term “resin” as used in both subparts (a) and (b) includes

both thermosetting resins4and also thermoplastic resins5.

4 The base does not require the thermoplastic property of being “repeatedly made soft and hard through heating and

cooling.” See Report, p. 13 fn. 3. The thermoplastic characteristic is only necessary to the preform, which requires

the ability to be softened to mold to the user’s teeth. Col. 2:22-24. The base only needs to be softened once when it

is initially formed in the manufacturing process. Its very purpose is to retain its rigidity and shape under

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That thermoplastic and thermosetting resins are both covered by Claim 17 of the ‘051

Patent is a conclusion that one of ordinary skill in the art of resins would understand in light of

the clear explanation of the hardening and softening characteristics that the resins must exhibit

during self-fitting. This conclusion is unchanged by the absence of an express statement in the

patent that the word “resin” includes thermosetting resins6. First, the accepted meaning and

definition of “resin,” even as used in commonly accepted dictionaries, includes both

thermosetting and thermoplastic materials7. Second, Federal Circuit precedent dictates that the

description of the preferred embodiment set forth in the Specification should not arbitrarily be

interpreted as limiting the scope of the claim, but rather should be viewed as providing an

example of at least one embodiment of the invention that falls within the scope of the claims8.

temperatures that will soften the preform. See Col. 2:26-30; Col. 4:59-64. Accordingly, it is not necessary for the

base to be thermoplastic; it could just as simply be permanently hardened after manufacture, the defining

characteristic of a thermosetting resin. See Report, p. 13 fn. 3.

5 The base and preform could each be fabricated from thermoplastic resins as long as the thermoplastic resin used

for the base has a softening temperature and hardness that meet or exceed those minimum values in subpart (a) of

the claim and also exceed the softening temperature and hardness of the thermoplastic resin used to fabricate the

corresponding preform.

6 Claim 17 does not include the words “thermoplastic” or “thermosetting.” Any reference to thermoplastic resins is

only in the Specification where an example of an embodiment of the invention is described.

7 The Report relies on the website www.dictionary.reference.com/browse/resin for the definition of “resin.”

Notably, the American Heritage Dictionary and the American Heritage Stedman’s Medical Dictionary exhibited on

this webpage explicitly state that the definition of “resin” includes thermosetting and thermoplastic materials and the

remaining definitions exhibited there implicitly include thermosetting and thermoplastic in their definitions.

8 Although a claim should be read in light of the specification, it is particularly inappropriate to arbitrarily import

attributes of the preferred embodiment portion of the specification into the claims as limitations. Innova/Pure

Water, Inc., 381 F.3d at 1117; see also Burke, 183 F.3d at 1341. “References to a preferred embodiment, such as

those often present in a specification, are not claim limitations.” Laitram Corp., 863 F.2d at 865. “This court has

cautioned against limiting the claimed invention to preferred embodiments or specific examples in the

specification.” Texas Instruments, 805 F.2d at 1563. “Although the specification often describes very specific

embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”

Acumed, LLC v. Stryker Corp., 82 U.S.P.Q.2d 1481, 1485 (Fed. Cir. 2007) (citing Phillips, 415 F.3d at 1323)

(holding that specification did not limit claim term). The scope of the ‘051 Patent is not limited to the specific

examples or “embodiments” set forth in the ‘051 Patent, but rather covers all embodiments that satisfy the physical

and chemical requirements of Claim 17. Accordingly, the preferred embodiment should be not deemed to exclude

thermosetting resins which clearly satisfy the requirements of the claim.

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Third, the ‘051 Patent expressly states that the scope of the patent (as is dictated by the claims) is

not limited by the embodiment described in the Specification9. Fourth, DenTek’s own expert Dr.

Rancourt at the 9/5/07 Hearing, acknowledged that the base could be made from thermosetting

resins10. See 9/5/07 Hearing Tr. at p. 136:9-183:9

For these reasons, the recommended definition of “a resin” should be amended to include

thermosetting resins as follows: “a thermosetting or thermoplastic solid or semi-solid substance.”

II. Even though the claim language itself is devoid of any reference to manufacturing

by injection molding or to the physical appearance of the resulting device, the

recommended definition of the term “molding over the base” imposes

manufacturing specifications and structural requirements that improperly limit the

scope of Claim 17.

The Report’s definition of “molding over the base” improperly limits the scope of Claim

17 to manufacturing by injection molding and the physical appearance of the resulting device.

The Report recommends that “molding over the base” in Claim 17 should be defined as “the step

of injecting a thermoplastic resin, the characteristics of which are further defined in 17(b), into

an occlusal mold cavity into which the base described in 17(a) has been placed so that the

thermoplastic resin becomes an impression preform that covers the space between the side walls

9 The ‘051 Patent expressly disclaims any limitation that may be implied by the description and exemplars shown in

the Description section. The ‘051 Patent states:

It should be appreciated that the foregoing is merely exemplary and various other and alternate

thermoplastic resins may be selected for use in accordance with the invention. The principal

rheological and other attributes of the selected resins include a suitable softening temperature

range for the impression preform resin which will not create temperature induced discomfort or

damage to oral tissue, a softening temperature range and hardness of the base resin such that

substantial deformation of the base does not occur during fitting and over prolonged usage.

Col. 10:29-38 (emphasis added). The words “various other” modify the word resin. Thermosetting resins fall

within the “various other” types of resins contemplated by the ‘051 Patent.

10 Although the Court’s Report states that it deems the intrinsic evidence in the ‘051 Patent sufficient to make a

recommendation regarding the disputed terms, it notes that the expert testimony at the 9/5/07 Hearing provided the

Court with background on the materials science of resins and the types of resins commercially available. Report, p.

8.

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of the base, the inner surfaces of the side walls, and the space above and on top of the horizontal

surfaces of the side walls of the base.” Medtech respectfully submits that the Court should

decline to adopt this definition because it improperly incorporates the limitations of injection

molding and structure.

A. Injection Molding Limitation is Improper.

The recommended definition for “molding over the base” improperly limits the

fabrication process of the invention to “injection molding.” The Report concludes that

“incorporating the process of injecting the impression preform resin into a mold that already

contains the base into the definition of ‘molding over the base’ is appropriate,” for two reasons:

“[1] the parties discussed the process of injection molding with the Court at the Markman

hearing and [2] the preferred embodiments describe using injection molding to mold the

impression perform over the base.” Report, p. 17. Neither reason is appropriate to limit Claim

17. Accordingly, Medtech respectfully submits that the recommended definition should not be

adopted because it imports limitations on the manufacturing process from the Specification and

its exemplary embodiment.

The Report’s requirement that the term “molding over the base” dictates that a particular

type of manufacturing is required by Claim 17 – namely that Claim 17 requires that only

“injection molding” may be used to the exclusion of any other manufacturing or fabrication

process – is unsupported by the intrinsic and extrinsic evidence in this case, as well as Federal

Circuit precedent11. See Report, p. 17 (“injecting a thermoplastic resin . . . into an occlusal mold

11 It is well-settled that patents, and the claims contained therein, are not intended to be manufacturing specifications

or production documents. Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544, 1562 (Fed. Cir. 1987),

vacated on jurisdictional grounds, 486 U.S. 800 (1988), and cited with approval on remand, 870 F.2d 1292 (7th Cir.

1989); see also CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1339 (Fed. Cir. 2003); S.C. Johnson & Son,

Inc. v. Carter-Wallace, Inc., 614 F. Supp. 1278, 1302 (S.D.N.Y. 1985), aff’d on point, vacated in part on other

grounds, 781 F.2d 198 (Fed. Cir. 1986) (“There is no need for a manufacturing specification.”). “Patents are not

production documents, and nothing in patent law requires that a patentee must disclose data on how to mass-produce

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cavity”).

The Report states that it bases its recommendation on the parties’ discussion of injection

molding at the 9/5/07 Hearing and the Preferred Embodiments section of the ‘051 Patent.

Report, p. 17. However, Medtech did not adopt any such limitation on its manufacturing

processes at the 9/5/07 Hearing. Also, there are no references to injection molding in the claim

at issue. Instead, any mention of injection molding in the ‘051 Patent is in the Specification of

the Patent. Relevant case law cited above supports the conclusion that Claim 17 is not limited by

its description of a preferred embodiment (or otherwise) in the Specification. In fact, in this

case, the ‘051 Patent particularly and expressly teaches away from such limitations:

Since various possible embodiments might be made of the present

invention and since various changes might be made in the

exemplary embodiments shown herein, without departing from the

spirit if the invention, it should be understood that all matter herein

described or shown in the accompanying drawings should be

interpreted as illustrative and not in a limiting sense.

‘051 Patent, Col. 10:61-67. Accordingly, it is improper to import “injection molding” from the

exemplary embodiments into the definition of “molding over the base.”

Other manufacturing or fabrication processes may be used to achieve the invention. As

acknowledged by Dr. James Rancourt, DenTek’s own expert witness at the 9/05/07 Hearing, the

impression preform could be molded over the base through any number of molding techniques,

not just injection molding. 9/5/07 Hearing Tr. at p. 142:9 – p. 147:18. For example, Dr.

Rancourt testified that an impression preform could also be fabricated simply by inserting the

resin material into any two-piece mold and then closing the mold. Id. Therefore, discussing at

oral argument one manufacturing process should not be to the exclusion of the others mentioned.

the invented product, in patents obtained on either individual parts of the product or on the entire product.”

Christianson, 822 F.2d at 1562. Moreover, “the law requires that patents disclose inventions, not mass production

data, and the patents enable the practice of inventions, not the organization and operation of factories.” Id.

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The preferred embodiments should not limit Claim 17. There are no references to

injection molding in Claim 17. Claim 17 does not claim or place any limitations on the process

by which the base or preform may be molded. Nowhere in the ‘051 Patent is injection molding

stated to be the only way to mold the device. Rather, injection molding is described as an

example of one way that the device may be manufactured in the Description section of the

Specification. Claim 17 is not limited by its description of a preferred embodiment (or

otherwise) in the Specification.

Merely describing an example of the invention is not limiting on Claim 1712. In fact, to

adopt such a limitation is improper in this case. The Federal Circuit instructs that it is

particularly inappropriate to import attributes of the preferred embodiment portion of the

specification into the claims as limitations. Innova/Pure Water, 381 F.3d at 1117; see also

Burke, 183 F.3d at 1341. “References to a preferred embodiment, such as those often present in

a specification, are not claim limitations.” Laitram Corp., 863 F.2d at 865. “This court has

cautioned against limiting the claimed invention to preferred embodiments or specific examples

12 There is a “thin line” between reading a claim in light of the specification and the well-established principle that

the specification cannot import limitations into the claims. Comark Comm., 156 F.3d at 1186-87; Arlington Indus.,

Inc. v. Bridgeport Fittings, Inc., 345 F.3d 1318, 1327 (Fed. Cir. 2003). If a claim term is readily apparent to one

with ordinary skill in the relevant art, then consideration of the specification and the prosecution history is typically

limited to confirming whether the ordinary meaning applies or whether the patentee intended to deviate from this

meaning. Interactive Gift Express, 256 F.3d at 1331; Ventana Med. Sys., Inc. v. Biogenex Labs., Inc., 473 F.3d

1173, 1179 (9th Cir. 2006) (holding that district court improperly imported limitations from specification when

interpreting claim term). The Federal Circuit has repeatedly recognized that there is a difference between construing

a term appearing in a claim, and adding a limitation that is not there in the first place. The former is permissible; the

latter is not. See, e.g., Interactive Gift Express, 256 F.3d at 1331-32 (“in looking to the specification to construe

claim terms, care must be taken to avoid reading limitations appearing in the specification . . . into [the] claims”)

(citations omitted); Burke, 183 F.3d at 1340 (“Consistent with the principle that the patented invention is defined by

the claims, we have often held that limitations cannot be read into the claims from the specification or the

prosecution history.”); Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1348 (Fed. Cir. 1998) (“interpreting what is

meant by a word and a claim is not to be confused with adding an extraneous limitation appearing in the

specification, which is improper”). In Liebel-Flarsheim Co. v. Medrad, Inc., the Federal Circuit noted that the key

to looking to the specification is to view it “without unnecessarily importing limitations from the specification into

the claims.” 385 F.3d 898 (Fed. Cir. 2004) (citations omitted). “These two rules lay out the general relationship

between the claims and written description.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248

(Fed. Cir. 1998).

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14

in the specification.” Texas Instruments, 805 F.2d at 1563. “Although the specification often

describes very specific embodiments of the invention, we have repeatedly warned against

confining the claims to those embodiments.” Acumed, LLC v. Stryker Corp., 82 U.S.P.Q.2d at

1485 (citing Phillips, 415 F.3d at 1323) (holding that specification did not limit claim term).

For these reasons, Claim 17 should be construed without any limitation on the manner in

which the base or preform are molded, fabricated or manufactured.

B. Structural Limitation is Improper.

Medtech also submits that the recommended definition for “molding over the base” also

improperly incorporates structural limitations into Claim 17. Specifically, the Report asserts that

the definition should require the molding process to result in a preform that “covers the spaces

between the side walls of the base, the inner surfaces of the side walls, and the space above and

on top of the horizontal surfaces of the side walls of the base.” Report, p. 16. The Report bases

the adoption of such a structural limitation on (1) the section entitled “Summary of the

Invention” and (2) the illustrations contained in the Preferred Embodiment section. Report, p.

17. However, neither of the stated reasons support the structural limitations. Notably, the Court

expressly found that to incorporate structure into the claim was improper when it construed the

term “an impression preform.” Report, pp. 19-2013. Accordingly, Medtech submits that this

Court should adopt Medtech’s definition for “molding over the base” as “the step of forming the

impression preform of the appliance into a shape on top of the appliance base.”

13 As noted by the Court in its Report where it recommends a definition for “an impression preform,” it also is

inappropriate to incorporate structural subparts into Claim 17 that are found in other claims of the ‘051 Patent. The

Court specifically states, “there is no indication that Claim 17 was meant to incorporate the structural description of

the impression preform as it is stated in Claims 1 and 13, and there is no indication that Claim 17 was meant to be

dependent on Claims 1 and 13 . . .Accordingly the fact that Claim 1 and 13 are referenced in other claims and are

not referenced in Claim 17 gives rise to the presumption that the limitations – the structural descriptions –include in

Claims 1 and 13 were not intended to be present in Claim 17.” Report, pp. 19-20.

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(1) The Summary is not a proper basis for imposing structural limitations on

Claim 17.

The Summary is part of the Specification section of a patent. It is simply “a brief

summary of the invention indicating its nature and substance, which may include a statement of

the object of the invention” and precedes the detailed description of the invention. 37 C.F.R. §

1.73. The summary “should be commensurate with the invention as claimed and any object

recited should be that of the invention as claimed.” Id. The Summary in the ‘051 Patent

complies with 37 C.F.R. § 1.73 because it jointly summarizes the claims directed to the structure

of the device (Claims 1-16) and the claim directed to the method by which the device is

manufactured/fabricated (Claim 17). Thus, because the ‘051 Patent claims both the structure of

the device in Claims 1-16 and the method of manufacturing the device in Claim 17, the

Summary of the ‘051 Patent must necessarily include a summary of the structure of the device

when it also recites the manner in which that device is made.

Medtech respectfully submits that the Report improperly relies on the Summary to

impose certain structural requirements on the shape of the base – namely that it must have side

walls with horizontal surfaces that can be covered by the impression preform. Likewise, the

recommended definition imposes structural limitations on the shape of the impression preform –

namely that it must cover the interior side walls of the base and the entire horizontal surface of

the base.

These structural limitations are contrary to the language of Claim 17 of the ‘051 Patent.

Of significance is the fact that there is not a single reference in Claim 17 to the structural

attributes of either the base or the impression preform. Absent those structural requirements

being expressly recited in Claim 17, to read them in from the Summary or other parts of the

Specification is improper. See Interactive Gift Express, 256 F.3d at 1331-32 (“in looking to the

Case 7:07-cv-03302-KMK-LMS Document 95 Filed 10/29/2007 Page 18 of 27
16

specification to construe claim terms, care must be taken to avoid reading limitations appearing

in the specification . . . into [the] claims”) (citations omitted); Laitram Corp. v. NEC Corp., 163

F.3d 1342, 1348 (Fed. Cir. 1998) (“interpreting what is meant by a word and a claim is not to be

confused with adding an extraneous limitation appearing in the specification, which is

improper”).

Furthermore, the recommended definition does not consider that Claim 17 teaches only

that the interocclusal appliance is formed by molding an impression preform over a base in such

a manner as to create a unitary appliance. Col. 2:15-16; Col. 12:51-57. Claim 17 does not teach

that the shape of the preform is determined by the shape of the base. Rather, “molding over the

base” teaches that the shape of the preform is determined by the shape of the mold. See 9/5/07

Hearing Tr. at p. 146:10-22. The preform will assume whatever shape is dictated by the shape of

the mold from which it is made. This conclusion was supported by the testimony of DenTek’s

own expert Dr. Rancourt at the 9/5/07 Hearing. At the 9/05/07 Hearing, Medtech’s counsel

introduced a hand-drawn diagram that demonstrated examples of three different molds (and

accordingly three different shapes of the claimed invention) that could be used to shape the

preform. This document was entered into evidence as Exhibit 1 to the 9/5/07 Hearing. As

acknowledged by Dr. Rancourt, the diagram shows at least two possible configurations of a mold

whereby the preform would not cover the entire horizontal face of the base. See 9/5/07 Hearing

Tr. at p. 146:23 – p. 149:16. Dr. Rancourt specifically confirmed that at least these two mold

configurations would create a preform that does not cover the entire interior side walls and/or all

horizontal surfaces of the base:

Q: And on the top one, if we were to remove the device from

the mold, wouldn’t, in fact, the preform material not cover the

walls of the base?

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17

Dr. Rancourt: It would cover up to and beyond the top edges of

the walls, not over the top surface of what form the walls of the

base layer.

The Court: I’m sorry, say that again. It would cover - -

Dr. Rancourt: The preform material would cover up the interior

sidewalls of the base, and the way it is drawn here in Exhibit 1

would continue even higher, but would not cover the very top

horizontal surfaces of the base.

9/5/07 Hearing Tr. at p. 148:7-20 and Exhibit 1 thereto.

Q: And then the last one at the bottom, if we were to remove a

product from this interocclusal device mold, wouldn’t it, in fact

have no preform above the base walls, in fact, it would be level

with the base walls?

Dr. Rancourt: The way you have drawn this picture, the preform

would be up to the top edge of the interior walls of the base layer.

Q: That’s correct. So it would not go over the walls?

Dr. Rancourt: As drawn, right, the preform would not go over the

top edge of the base.

Id. at p. 149:5-12.

Furthermore, there are numerous other base and preform shapes that would fall within the

scope of Claim 17. For example, there is nothing in Claim 17 that prohibits the base from having

a flat horizontal surface that did not contain a groove or indentation. In such a case, it would be

impossible for a preform to cover the entirety of the interior side walls because no such walls

would exist. This, however, would not prevent a preform from being molded over this base.

Claim 17 also contemplates that the preform could cover less than all of the surface of the mold.

A mold could be configured that would render a preform that rested on only a portion of the

horizontal surface. Claim 17 only requires that the preform must be molded over at least some

portion, but not all, of the base and that the base and preform bond.

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18

Notably, the variety of permissible shapes that the base and preform may assume and still

fall within Claim 17 is further enhanced by the fact that the ‘051 Patent does not claim any one

method of bonding the preform to the base. The Specification even contemplates that primers,

bonding agents and texturing may be used to augment the bond:

In this regard, it should be noted that in the foregoing examples,

the surface 38 of the base over which the impression preform resin

is molded may include a coating of a bonding agent or priming

material or may be textured to augment the bond, all within the

context of the present invention.

Col. 10:45-50. Thus, Claim 17 is not limited by any shape or structure of the base or preform.

(2) The Figures or illustrations in the Specification do not impose structural

limitations on Claim 17.

As an additional basis for the recommendation that the structure of the device should

impose limitations on the claimed method of fabricating it, the Report relies on Figures 1, 4, 5,

and 7 of the ‘051 Patent. However, the ‘051 Patent includes both apparatus and method claims.

Claims 1-16 are apparatus claims which are directed to the structure of the invention. The

Description section of the patent describes the apparatus of Claims 1-16 in great detail. The

drawings are each associated with and directed to the description of the structure of the apparatus

of Claims 1-16. No Figures are referenced in Col. 5, lines 6-12 of the Description section of the

‘051 Patent where the method of Claim 17 is described. Yet, even if a figure or drawing were

associated with the method of producing the device as claimed in Claim 17, the Specification

would still not be limiting on Claim 17. Instead, the Specification merely provides an example

or embodiment of the invention, at best. In fact, the Federal Circuit has ruled that the Figures in

the Specification, like the Description section, are not limiting on the claim: “[A] patent’s

drawings may illustrate only a preferred embodiment and, therefore, do not limit the patent’s

claim scope.” Donald S. Chisum, 5A Chisum on Patents § 18.03[2][c]; see also Gart v. Logitech,

Case 7:07-cv-03302-KMK-LMS Document 95 Filed 10/29/2007 Page 21 of 27
19

Inc., 254 F.3d 1334, 1342 (Fed. Cir. 2002) (noting that “drawings [depicting the preferred

embodiment] are not meant to represent ‘the’ invention or to limit the scope of coverage defined

by the words used in the claims themselves”).

In the present case, the Figures merely illustrate exemplars of the device and not

limitations on the scope of Claim 17. See Col. 10:29-30. Indeed, the ‘051 Patent expressly

disclaims any limitations created by the illustrations, stating:

Since various possible embodiments might be made of the present

invention and since various changes might be made in the

exemplary embodiments might be made of the present invention

and since various changes might be made in the exemplary

embodiments shown herein, without departing form the spirit of

the invention, it should be understood that all matter herein

described or show in the accompanying drawings should be

interpreted as illustrative and not in a limiting sense.

Col. 10:61-67 (emphasis added). The illustrations, therefore, should not be used to determine the

meaning of the term “molding over the base” or to impose structural or other limitations on

Claim 17 or the ‘051 Patent. This Court should adopt Medtech’s proposed definition of

“molding over the base” which comports with the intrinsic and extrinsic evidence of this case as

follows: “the step of forming the impression preform of the appliance into a shape on top of the

appliance base.”

III. Although bonding methods have not previously been raised or addressed by the

parties or the Court, footnote 4 of the Report could be read to improperly limit the

invention to require that the unitary bond between the base and preform be

achieved only by one or more of the following: “heating the resin, coating the base

with a bonding agent or priming material, or texturing the surface of the base.”

Footnote 4 of the Report should not be read to improperly limit the invention to require

that the unitary bond between the base and preform be achieved only by the included methods.

Claim 17 of the ‘051 Patent does not claim the existence or nonexistence of any particular

bonding material or otherwise specify the particular manner in which any bond is achieved by

Case 7:07-cv-03302-KMK-LMS Document 95 Filed 10/29/2007 Page 22 of 27
20

the base and preform. See Claim 17. No such requirement or limitation exists. The

Specification does instruct that an important characteristic of the invention is the unitary bond of

the preform and the base. See ‘051 Patent, Col. 10:39-44. The ‘051 Patent states:

An additional and significant characteristic upon which the

selection of resins is predicated is the ability to obtain a unitary

molded over bond between the base and the preform/maxillary

dentition encasement which is well-suited to withstand the high

shear and compression forces generated during bruxing and

clenching events.

Col. 10:39-44. The Specification then goes on to acknowledge that the bond between the base

and preform may be achieved in many ways in addition to those in which the base and preform

structurally fit together or in which the materials of the base and preform chemically bond

together:

In this regard, it should be noted that in the foregoing examples,

the surface 38 of the base over which the impression preform resin

is molded may include a coating of a bonding agent or priming

material or may be textured to augment the bond, all within the

context of the present invention.

Col. 10:45-50.

Although the Report recognized that a variety of bonding methods exist, the Report, most

likely unintentionally, could be read to create a finite list of suitable bonding methods which

would implicitly narrow the scope of Claim 17. Report, pp. 17-18 fn. 4. According to Footnote

4 of the Report:

Your Honor does not limit the creation of the bond to simply

“contacting a heated resin with the entire upper surface of the

base,” but instead leaves open the possibility that the unitary bond

that is formed between the impression preform and the base may

be achieved by any one or more of the following: heating the resin,

coating the base with a bonding agent or priming material, or

texturing the surface of the base, as envisioned by the inventor.

Case 7:07-cv-03302-KMK-LMS Document 95 Filed 10/29/2007 Page 23 of 27
21

Report, p. 18 footnote 4. This appears to limit the methods of bonding only to those recited in

footnote 4 of the Report.

However, the manner in which a bond may be achieved should not be confined to the

three examples set forth in the Report. There is no support in the patent or the record for

imparting such a limitation. Rather, the ‘051 Patent merely suggests that the unitary bond

achieved by the preform and the base may be achieved using a bonding agent, priming material

or texturing augmentation:

In this regard, it should be noted that in the foregoing examples,

the surface 38 of the base over which the impression preform is

molded may include a coating of a bonding agent or priming

material or may be textured to augment the bond, all within the

context of the present invention.

‘051 Patent, Col. 10:45-51. Using a bonding agent, priming material or texturing augmentation

or even a heated resin, as the Report suggests, is not required by the ‘051 Patent. The

contemplated bond between the base and preform could be achieved any number of ways,

including but not limited to using different shapes of the base and preform that structurally fit

unitarily together or materials that chemically bond. In fact, the ‘051 Patent does not recite an

exhaustive list of the ways that the bond may be achieved, but rather expressly disclaims any

such limitation on the bonding agent where it states:

Since various possible embodiments might be made of the present

invention and since various changes might be made in the

exemplary embodiments shown herein, without departing form the

spirit of the invention, it should be understood that all matter

herein described or shown in the accompanying drawings should

be interpreted as illustrative and not in a limiting sense.

Col. 10:61-67. The Court, therefore, should clarify that there is no limitation on the manner or

type of bonding the preform to the base in Claim 17 of the ‘051 Patent.

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22

IV. The definition of the term “an impression preform” should properly omit the

Report’s limiting phrase “consistent with the remainder of the requirements in

Claim 17” in order to conform to the Court’s reasoning and intent as stated on page

20 of the Report because the present construction can be read to improperly

incorporate all of the other terms of the entire Claim 17 and their limitations, rather

than the Court’s intended result of defining the disputed term as “a thermoplastic

resin which serves as an impression material” and that definition being later

independently modified by the chemical makeup as recited in subpart (b) of the

claim.

The Report’s definition of the term “an impression preform” should properly omit the

Report’s limiting phrase “consistent with the remainder of the requirements in Claim 17.” The

Report recommends that “an impression preform” be defined as “a thermoplastic resin which

serves as an impression material consistent with the remainder of the requirements in Claim 17.”

Report, p. 19. Medtech respectfully points out that this recommended definition appears

improperly to incorporate all other definitions of all other terms (and their limitations) of Claim

17 into “an impression preform.” This appears to deviate from the well-established principal that

terms within a claim must have certain meanings. See Markman v. Westview Instruments, Inc.,

517 U.S. 370, 390 (1996). Broader terms contained in a patent claim are modified by the

narrower terms in the claim. In Claim 17, no single term encompasses the limitation of the entire

claim. They are not incorporated into the term itself. To do so in Claim 17 would produce the

illogical result of incorporating the base and its defining properties in Claim 17(a) into the

definition of the impression preform described in Claim 17(b). Col. 12:48-57. It also would

incorporate the other limitations discussed previously.

Accordingly, Medtech submits that the clause “consistent with the remainder of the

requirements in Claim 17” should be omitted from the construction of the term “an impression

preform” and the remainder of the Court’s recommended construction be retained so that the

term “an impression preform” is construed properly to mean “a thermoplastic resin which serves

as an impression material.”

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23

CONCLUSION

Medtech encourages the Court to adopt the Report’s recommendations as to the

construction of the terms “interocclusal device” and “having approximately 30% by weight vinyl

acetate,” but respectfully objects to the recommended construction for “a resin,” “molded over

the base,” and “an impression preform,” as well as any limitation on the manner in which the

base and preform are bonded together.

Medtech respectfully requests that the Court grant oral argument on a date and at a time

designated by the Court on Medtech’s Objection to the Report and Recommendation Regarding

Disputed Terms of Claim 17 of U.S. Patent No. 6,830,051.

Dated: October 29, 2007

New York, New York

Respectfully submitted,

ALSTON & BIRD LLP

By: s/ Karl Geercken

Karl Geercken (KG 5897)

Amy Manning (AM 0338)

90 Park Avenue

New York, New York 10016-1387

(212) 210-9471 (phone)

(212) 210-9444 (facsimile)

karl.geercken@alston.com

amy.manning@alston.com

Todd R. David, GA BPR No. 206526

ALSTON & BIRD LLP

One Atlantic Center

1201 West Peachtree Street

Atlanta, Georgia 30309-3424

todd.david@alston.com

W. Edward Ramage, TN BPR No. 16261

BAKER, DONELSON, BEARMAN,

CALDWELL & BERKOWITZ, P.C.

Case 7:07-cv-03302-KMK-LMS Document 95 Filed 10/29/2007 Page 26 of 27
24

Commerce Center, Suite 1000

211 Commerce Street

Nashville, Tennessee 37201

(615) 726-5600

eramage@bakerdonelson.com

Micheline Kelly Johnson, TN BPR No. 13847

Clinton P. Sanko, TN BPR No. 23354

BAKER, DONELSON, BEARMAN,

CALDWELL & BERKOWITZ, P.C.

1800 Republic Centre

633 Chestnut Street

Chattanooga, Tennessee 37450-1800

(423) 756-2010

mjohnson@bakerdonelson.com

csanko@bakerdonelson.com

Lea Hall Speed, TN BPR No. 19410

Samuel F. Miller, TN BPR No. 022936

(motion for pro hac pending)

BAKER, DONELSON, BEARMAN,

CALDWELL & BERKOWITZ, P.C.

165 Madison Avenue

Suite 2000

Memphis, Tennessee 38103

(901) 577-2175

gpodesta@bakerdonelson.com

lspeed@bakerdonelson.com

smiller@bakerdonelson.com

Attorneys for Plaintiff Medtech Products Inc.

Case 7:07-cv-03302-KMK-LMS Document 95 Filed 10/29/2007 Page 27 of 27