*NOT FOR PUBLICATION* 

OREXO,AB, 

UNITED STATES DISTRICT COURT 

DISTRICT OF NEW JERSEY 

RECEIVED 

MAR 3 1 2014 

AT 8:30 M 

WILLIAM T. WALSH CL RK 

Plaintiff, Civil Action No.: 11-3788 (FLW) 

v. 

MYLAN PHARMACEUTICAL, INC. and 

MYLANINC., 

Defendants. 

WOLFSON, District Judge: 

OPINION 

In this claim construction Opinion, the Court construes certain disputed terms in U. 

Patent No. 6,791,910 (the '"910 Patent"), held by PlaintiffOrexo ("Plaintiff' or "Orexo"), whi h 

describes an invention for a sublingual method of administrating active pharmaceutical agen s. 

In this infringement suit, Plaintiff accuses Defendants Mylan Pharmaceutical, Inc. and Myl n 

Inc. 1 of engaging in activities directed toward infringement of the '910 Patent by, inter ali_, 

submitting an abbreviated new drug application designated ANDA seeking FDA approval o 

manufacture and commercially market its proposed Zolpidem Tartrate Sublingual product. T e 

Court has considered the parties' written submissions and presentations at the Markman hearin , 

as well as expert declarations. The Court's claim constructions are reflected in the chart locat d 

on the last page of this Opinion. 

Because the parties refer to these defendants as one entity, the Court will, thus, refer to 

defendants collectively as "Mylan" or "Defendant." 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 1 of 38 PageID: 9786
BACKGROUND 

I. Overview of the '910 Patent 

Orexo manufactures Edluar, a sublingual tablet for treating insomnia. The acti e 

ingredient in Edluar is zolpidem tartrate. Orexo's sublingual drug delivery technology used n 

Edluar is based on the '91 0 Patent, the subject of this patent suit. While the invention taught n 

the '91 0 Patent is a sublingual pharmaceutical composition to be used in the treatment of acu e 

disorders, such as insomnia, it also teaches a method for making such composition. 

The pharmaceutical composition described by the '910 Patent has three rna n 

components: (1) microparticles of a pharmaceutically active agent, (2) carrier particles, and (3) a 

bio/mucoadhesion promoting agent (bio/mucoadhesive ). These three components form discre e 

subunits within the pharmaceutical composition. ·Markman Hr' g Tr. p.6, ll. 1-2. Once t e 

composition is placed under the tongue, it dissolves into said subunits, and the presence oft e 

bio/mucoadhesive helps the subunits adhere to the mucosal surface under the tongue, allowi g 

for rapid absorption of the pharmaceutical active agent. Id., p. 6, ll. 23-25, p. 7, ll. 1-2. 

The objectives of the invention are as follows: 

1. To provide for the treatment of acute disorders by perorally administering at least o e 

pharmaceutically active agent in a manner giving rise to pharmacologically effecti e 

plasma levels of said agent or agents within a short time after administration. 

2. To provide a pharmaceutical composition suitable for that purpose; and to provide a 

method of making such a composition. 

3. To provide a method of manufacture of a medicament for sublingual administrati n 

containing a physiologically effective dose of at least one pharmaceutically acti' e 

compound useful in the treatment of acute disorders. 

'910 Patent at col. 2. 

2 

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II. Specification of the '910 Patent 

According to the '910 Patent, the pharmaceutical composition is comprised of an order d 

mixture containing a pharmacologically effective amount of at least one pharmaceutically acti e 

agent and a bio/mucoadhesion promoting compound. '91 0 Patent, col. 2, ll. 51-56. The Pate t 

states that it is preferable to formulate such a composition by using the rapidly-dissolvi g 

technology taught in European Patent EP, 324 725 ("Nystrom"), which is a disclosed prior at. 

Id. at col. 3, 26-29. The '910 Patent further teaches that the composition covered by Nystrom is 

comprised solely of pharmaceutical agents, in a finely dispersed state, covering the surface o a 

substantially larger carrier particle, and that the composition disintegrates rapidly in wat r, 

thereby dispersing the microscopic drug particles or pharmaceutical agents. Id. at col. 3, ll. 3 -

34. Indeed, according to Nystrom, the dissolution of the drug would take place in the stomac , 

where there is a relatively large volume of liquid to dissolve the drug particles. Id. at col. 3, 3 -

42. 

In contrast, the '910 Patent allows the drug to dissolve in an environment with a ve y 

small amount of water-the mouth. ld. at col. 3, ll. 42-46. In that regard, the '910 Pate t 

teaches that it is possible to use ordered mixtures for sublingual administration, where t e 

volume of liquid available as a solvent is limited to a few milliliters, which, previously, has n t 

been considered a feasible approach. Id. Similarly, the fact that dissolution occurs in the mout , 

and not the stomach, allows the '910 patent to be used in conjunction with active agents who e 

efficacy is negatively affected by dissolution in gastro-intestinal liquids. See Id. at col. 1, ll. 4 -

56. 

An issue that arises with previous methods of sublingual administration is that patien s 

swallow the medication that dissolves in their saliva before the active ingredient adheres to t e 

3 

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mucosa. This can lead to erratic drug absorption. Id. at col. 2, 11. 62-64. To combat t is 

problem, the '91 0 Patent inc~udes a bio/mucoadhesion promoting agent, which helps the acti e 

agent adhere to the mucus membranes. Id. at col. 3, 11. 57-59. According to the Patent, t e 

expression "mucoadhesion" denotes an adhesion to mucous membranes which are covered y 

mucus, such as those in the oral cavity. Id. at col. 3, 11. 65-67, col. 4, I. 1. Together with its 

mucoadhesive properties, the bio/mucoadhesive used in the composition may also possess tl e 

ability to swell and expand when in contact with water, helping the composition dissolve in tl e 

presence of water. Id. at col. 3, ll. 57-63. The Patent additionally provides a list f 

bio/mucoadhesives known to those skilled in the art; however, said list is non-limiting, and a y 

compound that exhibits bio/mucoadhesive characteristics may be used in the invention. Id. t 

col. 5., ll. 8-22. In fact, the Patent specifies a method for determining whether a compound h s 

bio/mucoadhesive characteristics in vitro. Id. at col. 5, 11. 24-26. 

The bio/mucoadhesive agent can be incorporated into the pharmaceutical composition ·n 

several ways. In a preferred embodiment of the invention, a fine particulate quality of t e 

bio/mucoadhesive is mixed together with the coarse carrier for a sufficient time to produce n 

ordered mixture, where the finer particles exist as discrete primary particles adhered to t e 

surfaces of the carrier particles. Id. at col. 5, 11. 58- 63. This is also the method used £ r 

admixing the active agent in Nystrom. Id. at col. 5, 11. 63-65. 

In addition to detailing the preferential characteristics and methods of incorporating t e 

bio/mucoadhesive agent, the '91 0 Patent specification also teaches preferences for the carri r 

particles and the active agent. For example, the '91 0 Patent instructs that the carrier particl s 

used in the composition have a preferred size from 50 to 750 J.Lm. Id. at col. 4, I. 28. The carri r 

particles should also be highly soluble in water and be receptive to the incorporation of a 

4 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 4 of 38 PageID: 9789
bio/mucoadhesive agent. Id. at col. 4, 11. 34-37. Like the non-limiting list ofbio/mucoadhesiv s, 

the '91 0 Patent delineates potentially useful carrier particles. A similar list is also included r 

active agents that are well-suited to administration by the invention. Id. at col. 6. As stated, t is 

invention is useful for treating conditions that require rapid and temporary onset of relief, such s 

pain and insomnia. Id. at col. 6, 11. 33-37. 

III. Prosecution History of the '91 0 Patent 

The original application of what would become the '910 Patent was initially rejected 

the patent examiner for obviousness in light of the prior art-the Nystrom Patent. 

Koutsoubas Decl., Ex. 2 at ORM_00000159. In the original '910 Patent application, the '91 0 

Patent disclosed the following combination of components: MCC (as a bio/mucoadhesiv ), 

cross-linked PVP (as the disintegrant), and the carbohydrate (mannitol). See Id. 

ORM _ 00000161. Nystrom also disclosed those three same compounds for use in the Nystro 

invention, albeit the functions of the components differed from the '910 Patent. Because ofth's 

overlap, however, the examiner rejected the '910 application for obviousness. See Id. n 

response, the applicants amended the application, removing MCC from the list of possib e 

bio/mucoadhesives. See id. at ORM_0000178. In their amendment, the applicants explain d 

that the inclusion of the MCC in the list of bio/mucoadhesives was an error, see Id. t 

ORM_0000181, and expressly disclaimed MCC as a bio/mucoadhesive. Eventually, He 

application was accepted and MCC was not included in the list ofbio/mucoadhesives. 

IV. Claims at Issue 

Terms in Claims 1 and 19 are disputed. The full language of those claims appears belo , 

followed by a list of the disputed terms. 

5 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 5 of 38 PageID: 9790
Claim 1: A pharmaceutical composition for the treatment of acute disorders by sublingual 

administration, comprising an essentially water-free, ordered mixture of microparticles of at le st 

one pharmaceutically active agent adhered to the surfaces of carrier particles, said particles bei g 

substantially larger than said microparticles and being water-soluble, and a bioadhesion and/ r 

mucoadhesion promoting agent mainly adhered to the surfaces of the carrier particles. 

Claim 19: A method for the treatment of acute disorders, wherein to an individu I 

afflicted with said disorder is administered sublingually at least one dose unit of an essential y 

water-free pharmaceutical composition containing an effective amount of at least o e 

pharmaceutically active agent in the form of microparticles adhered to the surfaces of carri r 

particles, which are substantially larger than said microparticles, and are essentially wate -

soluble, and a bioadhesion and/or mucoadhesion promoting agent. 

I d., col. 10. 

Disputed claim terms: 

A. "Essentially water-free" (claims 1 and 19) 

B. "Bioadhesion and/or mucoadhesion promoting agent" (claims 1 and 19). 

C. "Ordered mixture" (claim 1) 

D. "Microparticles of at least one pharrriaceutically active agent" (claims 1 and 19). 

E. "Adhered to the surfaces" (claims 1 and 19). 

F. "Substantially larger" (claims 1 and 19). 

G. "Treatment" (claims 1 and 19). 

H. "Effective amount" (claim 19). 

On the next page, the Chart represents the parties' respective proposed constructions fc r 

each of the disputed terms. 

6 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 6 of 38 PageID: 9791
prevent the bio/mucoadhesion 

promoting properties in a 

pharmaceutical composition for 

sublingual administration. 

A material that enables 

adhesion of an active agent(s) to 

oral mucous membranes, oral 

mucosa or oral biological 

surfaces. 

Microcrystalline Cellulose 

''""'''''""·'"',,, ("MCC") is not a bioadhesion ,,,v· .•• ,,;••,,::jri;;;/,,: and/or mucoadhesion promoting 

agent. 

A drug, in particulate form that 

is used for the treatment of 

medical conditions. 

Pharmaceutically active agent 

includes zolpidem and its 

pharmacologically acceptable 

salts and specifically zolpidem 

tartrate. 

No water is intentionally added 

manufacturing process. 

" 

A substance that is effective in •1u"''-11Jl5 

active agent adhere to the oral 

For the '910 Patent, neither 

microcrystalline cellulose nor £!~~~:!!!~1!. 

polyvinylpyrrolidone is such 

Particles of the pharmaceutical 

agent have a particle size no 

about 24 microns. 

active 

ter than 

Active agent held at the outside Binding to the surfaces 

part or layer of carrier particles. 

Carrier particles are appreciably Substantially greater than 24 mi 

> ~ctZ.;:~~ ~.:;:;,c,;:; ~·-ZI 

larger than the microparticles of 

the pharmaceutically active 

ingredient. 

The particles of at least one 

material distributed fairly 

evenly on carrier particles. 

The application of medicines, 

surgery, psychotherapy, etc., to 

~'•'·''~''·"· ,.,'.""'''···'"'·"'· a patient or to a disease or 

symptom. 

therapeutic response 

A mixture of carrier particles 

particles of an active phaJ:nlcice:U!ttcal agent. 

Control [the acute disorder] 

The amount of active agent ent for 

treatment of an acute disorder is in the 

form of microparticles 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 7 of 38 PageID: 9792
DISCUSSION 

I. Standard of Review 

Claims define the scope of the inventor's right to exclude. Phillips v. A WH Corp .. 4 I 5 

F.3d 1303, 1312 (Fed. Cir. 2005). Claim construction determines the correct claim scope, and 's 

a determination exclusively for the court as a matter of law. Markman v. Westvie y: 

Instruments. Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995) (en bane). Indeed, the court can on y 

interpret claims, and "can neither broaden nor narrow claims to give the patentee somethi g 

different than what it has set forth" in the specification. E.I. Du Pont de Nemours v. Philli § 

Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir.1 988). 

This interpretive analysis begins with the language of the claims, which is to be read and 

understood as it would be by a person of ordinary skill in the art. Dow Chern. Co. v. SumitomQ 

Chern. Co .. 257 F.3d 1364, 1372 (Fed. Cir. 2001); see also Markman. 52 F.3d at 986 ("The foe s 

[in construing disputed terms in claim language] is on the objective test of what one of ordina y 

skill in the art at the.time of invention would have understood the terms to mean"); Phillips. 41:5 

F .3d at 1312-13. In construing the claims, the court may examine both intrinsic evidence (e. . , 

the patent, its claims, the specification, and prosecution history) and extrinsic evidence (e.g., 

expert reports, testimony, and anything else). Pitney Bowes, Inc. v. Hewlett-Packard Co .. 182 

F.3d 1298, 1309 (Fed. Cir. 1999). Courts first look to intrinsic evidence. when interpreting 

disputed terms. Vitronics Corp. v. Conceptronic, Inc ... 90 F.3d 1576, 1582 (Fed .Cir. 1996 . 

Generally, words in patent claims are given their "ordinary and accustomed meaning s 

understood by one of ordinary skill in the art" at the priority date of the patent application. Do 

Chern., 257 F.3d at 1372; K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1362 (Fed. Cir. 1999 . 

The claims must be construed objectively in the context of both the particular claim and the 

8 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 8 of 38 PageID: 9793
entire patent because "the claims themselves provide substantial guidance as to the meaning f 

particular claim terms," and claim terms are normally used consistently throughout t e 

patent. Phillips. 415 F.3d at 1313-14. 

Moreover, courts are instructed to look to the specification, which is a written descripti n 

of the invention. "[C]laims 'must be read in view of the specification, of which they are a pa . ' 

"Id. at 1315 (quoting Markman. 52 F.3d at 979). Indeed, the specification is perhaps "the singe 

best guide to the meaning of a claim term" due to its statutory requirements of being in "full, 

clear, concise, and exact terms." Id. at 1316; see 35 U.S.C. § 112. "The specification acts as a 

dictionary when it expressly" or implicitly defines terms used in the claims. Markman. 52 F.3d t 

979. Thus, it effectively limits the scope of the claim. On Demand Mach. Co . v. In ra1 _ 

Industries, Inc., 442 F.3d 1331, 1340 (Fed.Cir.2006). Due to its nature, "the specification ' s 

always highly relevant to the claim construction analysis. Usually it is dispositive " 

Id. (quoting Vitronics Com .. 90 F.3d at 1582). 

Extrinsic evidence includes all evidence external to the patent and prosecution histor , 

i.e., expert and inventor testimonies, dictionaries, and learned treaties. Markman. 52 F.3d at 98 

It is considered supplemental to the intrinsic evidence when ambiguities remai 

See Vitronics. 90 F.3d at 1583; Johnson Worldwide Assocs. v. Zebco Com .. 175 F.3d 985, 9 ·9 

(Fed. Cir. 1999). Yet, extrinsic evidence cannot be used to vary or contradict claim terms wh n 

their meanings are discernible from intrinsic evidence. C.R. Bird, Inc. v. U.S. Surgic· 1 

QmL., 388 F.3d 858, 862 (Fed. Cir. 2004). 

9 

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II. Disputed Terms 

A. Essentially Water-Free 

The parties dispute whether "essentially water-free" refers to the final pharmaceutic 1 

formulation or the process by which the formulation is made. Plaintiff proposes that "essential y 

water-free" means "a water. content that does not prevent the bio/mucoadhesion promoti g 

properties in a pharmaceutical composition for sublingual administration." Defendant, on t e 

other hand, contends that "essentially water-free" should be construed as "no water · s 

intentionally added during the manufacturing process." Thus, both parties acknowledge th Lt 

there may be some water present in the pharmaceutical composition,2 but they disagree as o 

whether the term "essentially water-free" applies to the final product or the process by which th t 

product is manufactured. 

Defendant premises its argument on this notion: what is destroyed by water cannot l e 

made with water. In that regard, Defendant reasons that because water interferes with tl e 

advantageous characteristics of the invention, there is no feasible way to create the invention 

using water. To support its construction, Defendant references a passage from the '910 pate 

which states: 

Irrespective of the form given to the preparation, it -is important that the 

preparation is essentially free from water, since its bio/mucoadhesion promoting 

character results from its practically instantaneous hydration when brought into 

contact with water or saliva. Premature hydration would drastically decrease the 

2 Indeed, as a general principle for claim construction, "essentially" refers to a lack of a stri t 

numerical limitation. See Edelstein v. Frank, 52 F.3d 1035, 1039-40 (Fed. Cir. 1995 . 

Consequently, "essentially water-free" cannot mean that the composition is entirely free frot 

water because that imposes a stringent limitation on the claims, and it would render "essentiall " 

meaningless. In fact, Defendant proposed several constructions during the parties' preheari g 

proceedings, some of which included language that "the ordered mixture contains so little wat r 

that there is no premature hydration of the bioadhesion and/or mucoadhesion promoting agent " 

Def. ['s] Responding Claim Construction Br. 14. 

10 

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mucoadhesion promoting properties and result in a premature dissolution of the 

active substance. 

'910 Patent, col. 7, 11. 36-43. From this excerpt, Defendant concludes that the "premature 

hydration" warned by the specification can only be avoided if there is no water added duri1 g 

manufacturing. However, in quoting the above passage, Defendant neglects to include t . e 

immediately preceding sentence which reads: "The ordered mixture prepared in accordance wi h 

the invention can be incorporated into various kinds of pharmaceutical preparations intended r 

sublingual administration." '910 Patent, col. 7, 11. 33-36. When read together, it becomes cle r, 

in this Court's view, that the term "preparation" is describing a pharmaceutical product, not a 

method of manufacture. Indeed, one of the definitions of "preparation" is, "something that is 

prepared; specifically: a medicinal substance made ready for use." Preparation definitio , 

Merriam-Webster. com, http://www.merriam-webster.com/dictionary/preparation. 

passage only describes the characteristics of the pharmaceutical substance or composition ··-

which would be essentially water-free -- and based on the plain language, the passage is silent n 

how that substance is made. 

Defendant also supports its construction with language from the Nystrom Pater t, 

contending that "essentially free from water," as used in the prior art, has the same meaning : s 

"essentially water-free." While the Court acknowledges that this language is interchangeabl ', 

the Court does not find that the language of the prior art supports Defendant's construction th tt 

preparation refers to a process. Mirroring the language of the '910 Patent, the prior art states: 

The ordered mixtures prepared in accordance with the invention can be 

incorporated in various kinds of pharmaceutical preparations .... Irrespective of 

the form given to the preparation, it is important that the preparation is essentially 

free from water, since the presence of water would result in premature dissolution 

of the active substance. 

11 

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Nystrom Patent col. 4-5, 11. 55-57, 65; 1-4 (emphasis added). Again, the word "preparation" in 

the above-quoted passage refers to a final pharmaceutical product. This passage teaches that t e 

final pharmaceutical product is essentially free from water and, similar to the '910 Pat nt 

passage relied upon by Defendant in this context, is silent as to the method of manufacture. 

Next, Defendant argues that when a process step is fundamental to the final product, a 

product claim can be limited by its method o(manufacture. According to Defendant, prior ca e 

law allows such a limitation. See, e.g., Andersen Corp. v. Fiber Composites, LLC 474 F.: d 

1361, 1375 (Fed. Cir. 2007) ("However, process steps can be treated as part of a product claim if 

the patentee has made clear that . the process steps are an essential part of the claim< d 

invention."). Defendant points to the portions of the preferred embodiments of the '91 0 Pate 1t 

that describe three water-free methods of producing the invention. The first is the "dry mixin " 

method of producing the ordered mixtures described in Nystrom. See '91 0 Pat~nt col. 3, 11. 2 i34. The second and third methods specify that a liquid can be used during the manufacturing ,f 

the composition, but it cannot be one that will cause the bio/mucoadhesive to swell. See '9 0 

Patent col. 6 11. 6-9; 15-16. 

In general, however, the scope of a product claim is not restricted to the process by whi h 

it is made. See Vanguard Prods. Com. v. Parker Hannifin Com., 234 F.3d 1370, 1372 (Fed. Cr. 

2000). While there are exceptions to this tenet, neither the language of the '910 Patent nor t e 

prosecution history supports the idea that this invention must be limited to a water-fr e 

manufacturing process. The prior cases that have allowed for this kind of limitation have do e 

so because the patentee specifically limited its own claims during the prosecution history. S e 

Id. For example, in Southwall Technologies, Inc. v. Cardinal IG Co., a product claim w s 

limited to a particular process because the patentee had specifically restricted its claim to a 

12 

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method of manufacture in order to avoid rejection for obviousness. 54 F.3d 1570, 1576 (F d. 

Cir. 1995). Here, the patentee never specifically disavowed methods of manufacture that utili e 

water in the '91 0 Patent application. And, a patentee is not required to specify every possi le 

method of producing its invention. SRI Int'l v. Matsushita Elec. Com. of Am., 77 F.2d 11 7, 

1121 (Fed. Cir. 1985). In fact, immediately following the embodiments cited by Defendant, t te 

'91 0 Patent explicitly states that there are other feasible methods of preparation. that are not 

described in the specification. See '910 Patent col. 6, ll. 18-19. Also, as a preamble to t e 

claims, the Patent explicitly states that only the claims, not the embodiments and examples, re 

limiting, and that it is possible to vary from the specification "without departing from t e 

inventive idea." Id. at col. 10, ll. 36-41. Accordingly, absent any clear and unambiguo s 

disclaimer, the preferred embodiments are not dispositive of a manufacturing process that does 

not include water. 

Defendant additionally points to the prosecution history as intrinsic evidence supporti 

its contention. Specifically, Defendant cites an excerpt from a previous claim rejection oft e 

'910 Patent where the patent examiner stated that "[t]he composition is an ordered mixture f 

microparticles that is free of water." Koutsoubas Decl., Ex. 2 at ORM_00000159 (Sept. 6, 

2002 Office Action at 4-5). In addition, the examiner said, "[t]he most important aspect oft e 

invention is the fact that the compound remains water-free so that the active agents do ot 

dissolve too quickly." Id. at ORM_00000160. From these statements, Defendant concludes that 

the examiner was under the impression that the composition must remain completely free f 

water throughout the process, even though the claim language inserts "essentially" befo ·e 

"water-free." First and foremost, the language cited by Defendant is consistent with Plaintifi s 

13 

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construction; like the passage Defendant cited from the '910 Patent, this language refers to t e 

final pharmaceutical composition and not the manufacturing process. 

Having found that the term "essentially water-free" describes the final composition, t 1e 

Court must accept a construction that elucidates the meaning of "essentially water-free" in t at 

light. Plaintiffs proposed construction - "A water content that. does not prevent t e 

bio/mucoadhesion promoting properties 1n a pharmaceutical composition for subling al 

administration" - accomplishes that goal. As referenced previously, for the purposes of cla1m 

construction, the use of "essentially" indicates that there is no fixed numerical.limitation to t e 

terms described thereby. See Edelstein, 52 F.3d at 1039. Plaintiffs construction contains .o 

numerical limitation; instead, it introduces a certain threshold for the level of water that can e 

present in a pharmaceutical composition covered by Claims 1 and 19. The construction indicat 3

S 

a likelihood that some water may be present in the pharmaceutical composition, whether t e 

water comes from ambient moisture or is introduced along with the excipients. See Peppas De l 

~ 35. 

As previously mentioned, the '910 Patent warns that "premature hydration" will interfe ·e 

with the bio/mucoadhesive properties of the preparation. See '91 0 Patent, col. 7, 11. 40-43. 

Considering that the hallmark of the invention is, in fact, its bio/mucoadhesive characteristi s, 

while there could potentially be some water in the preparation, it cannot be of an amount t at 

would destroy those essential properties. Therefore, Plaintiffs construction addresses t e 

inherent limitations of the invention without reading a process limitation into a product clai 

As such, the Court accepts Plaintiffs construction of "essentially water-free": "A water conte t 

that does not prevent the bio/mucoadhesion promoting properties in a pharmaceutical 

composition for sublingual administration." 

14 

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B. Bioadhesion and/or Mucoadhesion Promoting Agent 

As to this claim, both parties agree that a bioadhesion and/or mucoadhesion promoti 

agent helps the active agent adhere to the oral mucosa. There are a few semantic differenc s 

between the two proposed constructions, but in essence, the first portion of each of the parti s' 

proposals conveys the same idea. Plaintiff proposes "a material that enables adhesion of n 

active agent(s) to oral mucous membranes, oral mucosa, or oral biological surfaces." Tracki1 g 

the language of the '910 Patent, Defendant proposes "a substance that is effective in making t e 

active agent adhere to the oral mucosa" to describe the functional characteristics of t . e 

bio/mucoadhesive. Indeed, Defendant's proposed language comes directly from the '910 Pate t 

specification: "The bioadhesion and/or mucoadhesion promoting agent is effective in making t .~ 

active agent or agents adhere to the oral mucosa ... " '910 Patent, col. 3, 11. 57-59 (empha is 

added). I agree that the term "promoting agent" need not be further construed, particularly sin e 

it .is clear from the claim language and the specification what that term means. 

Defendant's construction. 

Additionally, the parties agree that, for purposes of the '910 Patent, Microcrystalli e 

Cellulose ("MCC") is not a bio/mucoadhesive because it was expressly disclaimed during tl e 

prosecution history. The parties' dispute relating to the definition of "bioadhesion and/ >r 

mucoadhesion promoting agent" is whether cross-linked polyvinylpyrrolidone ("cross-link d 

PVP") was also disclaimed or disavowed as a bio/mucoadhesive. Plaintiff proposes that MCC is 

the only compound expressly disclaimed as a bio/mucoadhesive, while Defendant contends th' t 

both MCC and cross-linked PVP were disclaimed. In that connection, Plaintiffs 

construction for the term "bioadhesion and/or mucoadhesion promoting agent" is: "a material 

that enables adhesion of an active agent(s) to oral mucous membranes, oral mucosa or o al 

15 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 15 of 38 PageID: 9800
biological surfaces. Microcrystalline Cellulose ("MCC") is not a bioadhesion an or 

mucoadhesion promoting agent." On the other hand, Defendant's construction is: "a substan e 

that is effective in making the active agent adhere to the oral mu9osa. For the '910 Patel t, 

neither microcr stalline cellulose nor cross-linked olidone is such an a 

(emphasis added). 

Defendant primarily relies on the prosecution history to support its construction. 

the prosecution of the '91 0 Patent, the '91 0 application was rejected for obviousness in light >f 

the fact that the Nystrom Patent, a prior art, disclosed the same combination of substances, i .. , 

. MCC, cross-linked PVP and mannitol. To cure this defect, the '910 applicant removed M C 

from the list of possible bio/mucoadhesive agents. See supra, Background, Sec. III. In so doing, 

the applicants attempted to distinguish the '91 0 application from Nystrom by stating: 

Moreover, applicants note that NYSTROM fails to mention muco- or bioadhesive 

components. In fact, NYSTROM fails to disclose or suggest a combination of 

ordered mixtures and mucoadhesive agents. Moreover, applicants note that one 

of ordinary skill in the art would appreciate that microcrystalline cellulose does 

not exhibit bio/mucoadhesive properties. While it is true that this is stated in the 

specification and claims, applicants have amended claims and specification to 

correct this obvious error. 

Koutsoubas Decl., Ex. 2 at ORM_00000181 (Feb. 23, 2003 Amendment, p. 6) (emphasis adde ). 

See Nystrom Patent, col. 3, ll. 17-18. Unpersuasively, Defendant argues that this statement n t 

only disavows MCC, but also cross-linked PVP as bio/mucoadhesive agents. According o 

Defendant, the above underlined statement cannot be true if cross-linked PVP 1s a 

bio/mucoadhesive in the '910 Patent because it was disclosed in Nystrom, albeit as a 

disintegrant. Indeed, cross-linked PVP was disclosed as a disintegrant in Nystrom in t] e 

following passage: 

The pharmaceutical disintegrant may comprise any substance which is known for 

this purpose by those skilled in the art. Particularly effective agents in this respect 

16 

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are those which swell drastically in water, through hydratization, and thus exhibit 

an increase in volume of up to 10-20 times their dry volume. Examples of such 

agents are cellulose and starch derivatives in the form of water-insoluble, crosslinked polymers which swell markedly in water. Derivatives of 

polvvinylpvrrolidone are other examples of such agents. 

Nystrom Patent, col. 3, ll. 8-18 (emphasis added). As such, Defendant reasons that because bo h 

MCC and cross-linked PVP are disclosed in the Nystrom Patent- albeit as disntegrants -- th y 

sho"!Jld nonetheless be excluded from the possible bio/mucoadhesives that could be used in t . e 

'91 0 Patent. 

In response to Defendant's argument, Plaintiff claims that the disputed passage was a 

general statement, based on the fact that the Nystrom Patent does not address whether any oft] e 

materials disclosed in that patent can function as a bio/mucoadhesive. Indeed, the Nystro n 

language does not include the term "bioadhesion and/or mucoadhesion promoting agent" )r 

anything similar in its specification or claims. Therefore, the applicants' statement seeming y 

explains such a distinction between the Nystrom Patent and the '91 0 Patent. 

However, Defendant argues that even though Nystrom never referred to MCC as a 

bio/mucoadhesive, nonetheless the patent examiner still rejected the patent for obviousne ;s 

because Nystrom disclosed MCC. Defendant further argues that, regardless of whether it w LS 

specifically noted in the patent, if MCC can function as a bio/mucoadhesive, then it is immaterial 

whether it was categorized as such in Nystrom. See In re Kao, 639 F.3d 1057, 1066 ("Th s, 

while it matters not whether the hypothetical skilled artisan would have appreciated t] e 

'correlation' at issue here, it matters greatly whether anything the skilled artisan would e 

prompted by the prior art to do is in fact within the scope of the pending claim"). Defenda t 

extends this line of reasoning to cross-linked PVP; however, that interpretation is incongruo s 

with the specification and embodiments of the '91 0 Patent because, if the Court were to app y 

17 

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such an interpretation, it would result in a disclaimer that essentially encompasses all t e 

compounds disclosed in the Nystrom Patent. 

To illustrate, in addition to disclosing MCC and cross-linked PVP as disintegran s, 

Nystrom also discloses Ac-Di-Sol, which is a commercial form of cellulose gum. See Nystr 

Patent, col. 3, ll. 18-22. In the '91 0 Patent, Ac-Di-Sol is categorized as both a bio/mucoadhesi e 

and a disintegrant. See '910 Patent col. 5, ll. 41-42; col. 7, ll. 20-24. It is also utilized in both 

embodiments of the '91 0 Patent, serving the dual function of bio/mucoadhesive and disintegrat t. 

See '91 0 Patent col. 8, ll. 6-7; col. 8, 11. 34-36. Applying Defendant's reasoning would result in 

the disavowal of Ac-Di-Sol. Considering that Ac-Di-Sol is employed in every preferr d 

embodiment of the '910 Patent, it would be illogical to adopt Defendant's interpretation of tl e 

prosecution history in this regard. 3 

Defendant also contends that the intrinsic evidence concerning MCC and cross-link d 

PVP is so similar that the disavowal of MCC during the prosecution history should also apply o 

cross-linked PVP. Defendant identifies three similarities between the intrinsic evidence relati g 

to MCC and cross-linked PVP: (1) both were disclosed in Nystrom; (2) both were noted in t e 

examiner's rejection; (3) both materials are listed only as disintegrants. Nevertheless, the e 

similarities are not sufficient to result in the disavowal of cross-linked PVP. Indeed, there is a 

"heavy presumption that claim terms carry their full ordinary and customary meaning, unless ... 

3 Defendant claims that the intrinsic evidence concerning Ac-Di-Sol and cross-linked PVP is 

different, and thus, cross-linked PVP can be disavowed without disavowing Ac-Di-Sol. 

According to Defendant, the statement made by the applicants in response to the examiner's 

initial rejection for obviousness should not apply to Ac-Di-Sol because Ac-Di-Sol was never 

referenced in that rejection. In other words, it is Defendant's position that, because the 

examiner's statement only referenced MCC and cross-linked PVP, any disavowal would only 

apply to those substances. Contrary to Defendant's assertion, the applicants' response referred o 

the entire Nystrom Patent, not merely the substances listed in the rejection. Koutsoubas Decl., 

Ex. 2 at ORM_00000181 (Feb. 23, 2003 Amendment, p. 6) ("In fact, NYSTROM fails to 

disclose or suggest a combination of ordered mixtures and mucoadhesive agents"). 

18 

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the patentee expressly relinquished claim scope." Epistar Com. v. Int'l Trade Comm'n, 566 F. d 

1321, 1335 (Fed. Cir. 2009). Therefore, "bioadhesion and/or mucoadhesion promoting age t" 

encompasses "any physiologically acceptable agent showing bio/mucoadhesive characteristi s" 

('910 Patent, col. 5, ll. 21-23), absent a clear relinquishment of scope. In that regard, he e, 

similarities between MCC and cross-linked PVP do not rise to the level of a clear 

relinquishment. First, the fact that both materials were disclosed in Nystrom as disintegrants h ts 

little relation to whether either is a bio/mucoadhesive in the context of the '91 0 Patent. Agai , 

for example, Ac-Di-Sol was also disclosed as a disintegrant in Nystrom, yet, Defendant has n )t 

argued that Ac-Di-Sol is not a bio/mucoadhesive in the context of the '91 0 Patent. Secon , 

while both agents were discussed in the examiner's rejection, the examiner did not treat M C 

and PVP as similar substances; rather, the examiner referenced cross-linked PVP as a 

disintegrant, and MCC as a bio/mucoadhesive. Finally, the '910 Patent states that there is n 

overlap between the disintegrating agents and the bio/mucoadhesives, and the two functions m y .._./ . 

be served by the same material. See '910 Patent, col. 7, ll. 25-28. While Defendant is correct ·n 

noting that the two categories are not necessarily equivalent, see Id., col. 7, ll. 29-32, that fa t 

does not preclude cross-linked PVP from qualifying as a bio/mucoadhesive.4 

I further note that the inclusion of MCC on the list of bio/mucoadhesives in the initial 

patent application was admittedly an error, which is why the applicants removed only MCC fro 

the list, and the examiner found that to be acceptable. See Koutsoubas Decl., Ex. 2 

ORM 00000181 (Feb. 23, 2003 Amendment, p. 6) ("Moreover, applicants note that one 

ordinary skill in the art would appreciate that microcrystalline cellulose does not exhi 

4 Whether cross-linked PVP is actually a bio/mucoadhesive is not being addressed at this stage< f 

the proceedings. 

19 

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bio/mucoadhesive properties. While it is true that this is stated in the specification and clai s, 

applicants have amended claims and specification to correct this obvious error"). Indeed, h d 

this error not been committed in the early application, Defendant would likely not be putti1 g 

forth the same argument. 

In conclusion, while the applicants expressly disclaimed MCC as a bio/mucoadhesi 

there is no equivalent disavowal for cross-linked PVP. Accordingly, Defendant attempts to build 

a case for disavowal of cross-linked PVP by piecing together statements from the prosecuti< n 

history. The law, however, requires more concrete evidence of a disavowal than Defendant h s 

provided. In fact, the Federal Circuit has found it "particularly important not to limit claim sco1 e 

passed on statements made during prosecution ' [a ]bsent a clear disavowal or contra y 

definition." Digital-Vending Services Intern., LLC v. University of Phoenix, Inc., 672 F. d 

1270, 1273 (Fed. Cir. 2012) (citing August Tech. Corp. v. Camtek, Ltd., 655 F.3d 1278, 12 6 

(Fed. Cir. 2011) (quoting Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fe . 

Cir. 2004)). No such "clear disavowal or contrary definition" exists in the prosecution histo y 

regarding cross-linked PVP as a bio/mucoadhesive. Moreover, the specification of the '9 0 

Patent makes clear that the list of bio/mucoadhesives is non-exhaustive. See '91 0 Patent, col. '5, 

11. 21-23. In fact, after the exemplary list of bio/mucoadhesive agents, the specification stat s: 

"[ m ]ore generally, any physiologically acceptable agent showing bio/mucoadhesi ·e 

characteristics may be used successfully to be incorporated in the carrier." '91 0 Patent, ~ol. 5, I. 

21-23 (emphasis added). The specification further details a method for determining whether a 

compound has bio/mucoadhesive characteristics in vitro. See '910 Patent, col. 5, ll. 23-2 ·. 

There would be no need to include a method for determining the mucoadhesive characteristics f 

20 

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a compound if the patent is restricted to the bio/mucoadhesives listed in the specificatio . 

5 

Indeed, Defendant recognizes that this is not a "classic disavowal," Markman Hr' g Trans. p. 2, 

1. 19, but a "classic disavowal" is exactly what the law requires. See Stora e Tech. Co . v. 

Cisco Sys., 329 F.3d 823, 833-34 (Fed. Cir. 2003) (explaining that a patent application's 

statement made before the [Patent Prosecution Office] must be clear and unambiguous o 

constitute a limitation of a patent claim); see also Schwin GmbH v. Putzmeist! 

Aktiengesellschaft, 305 F.3d 1318, 1324-25 (Fed. Cir. 2004). 

Based on the lack of any language in the '910 Patent or in its prosecution history clear y 

excluding cross-linked PVP as a potential bio/mucoadhesive, the Court rejects the Defendanfs 

proposal that cross-linked PVP cannot qualify as a bio/mucoadhesive. As a consequence, t e 

Court adopts Plaintiffs limiting language that "Microcrystalline Cellulose ("MCC") is not a 

bioadhesion and/or mucoadhesion promoting agent." Thus, the Court construes the te 

"bioadhesion and/or mucoadhesion promoting agent" as follows: "a substance that is effective n 

making the active agent adhere to the oral mucosa. Microcrystallin~ Cellulose ("MCC") is not a 

bioadhesion and/or mucoadhesion promoting agent." 

C. Ordered Mixture 

The parties dispute the meaning of "ordered mixture" in claim 1. Plaintiffs propos d 

construction is based on a general scientific understanding of the term "ordered mixture," wi h 

5 Defendant attempts to rely on the statutory construction principle, expressio unius est exlusio 

alterius, which means: the mention of one thing implies an intent to exclude similar things that 

were not mentioned. Thus, according to Defendant, since the '91 0 Patent mentions suitable 

bio/mucoadhesives and cross-linked PVP was omitted from that list but included as a 

disintegrant, there is an implied intent to exclude cross-linked PVP from the bio/mucoadhesives 

But, importantly, expressio unius est exlusio alterius does not apply to non-exhaustive lists. Se 

generally, United States v. Comelio-Pena, 435 F.3d 1279, 1284 (lOth Cir. 2006); Singh-Kaur v. 

Ashcroft, 385 F.3d 293, 307 (3d Cir. 2004); Exelon Generation Co., LLC v. Local 15, IBEW, 

676 F.3d 566, 571 (ih Cir. 2012). 

21 

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support from various academic articles. 6 From these articles, Plaintiff concludes that an "order d 

mixture" is formed when one type of particle is distributed fairly evenly on carrier particles a d 

the two different types of particles do not need to be the same size. Plaintiffs propos d 

construction is: "The particles of at least one material distributed fairly evenly on carri ·r 

particles." Generally, Defendant does not dispute the foregoing principles; rather, Defendant s 

construction specifically describes the components of the ordered mixture as set forth in the '91 0 

Patent, because, according to Defendant, its construction is supported by a plain reading of clai 

1. Its proposal reads as: "A mixture of carrier particles and adherent particles of an acti e 

pharmaceutical agent." 

At the outset, the Court finds Plaintiffs construction overly broad. Claim 1 provides: 

A pharmaceutical composition for the treatment of acute disorders by sublingual 

administration, comprising an essentially water-free, ordered mixture of 

microparticles of at least one pharmaceutically active agent adhered to the 

surfaces of carrier particles, said particles being substantially larger than said 

microparticles and being water-soluble, and a bioadhesion and/or mucoadhesion 

promoting agent mainly adhered to the surfaces of the carrier particles. 

'910 Patent, col. 10, 11. 34-41 (emphasis added). Based on that language, "ordered· mixture",' s 

used in the claim, describes a certain combination of particles. Hence, giving "ordered mixtur " 

its general scientific meaning, as suggested by Plaintiff, does not suffice here. Indeed, the Cou t 

cannot define the term "ordered mixture" in isolation, without the accompanying language oft e 

claim. See Bd. of Regents v. BenO Am. Com., 533 F.3d 1362, 1368 n.5 (Fed. Cir. 2008) ("Oth r 

6 Plaintiff primarily supports its argument with an article by Hersey that was cited in an article by 

C. Nystrom and M. Westerberg, which was the foundation for the Nystrom Patent. The Hersey 

article describes, generally, the difference between ordered mixing and random mixing: 

"Ordered mixing may be considered to be different from random mixing since it does not requir 

equally sized or weighted particles it requires particle interaction, i.e. adsorption, chemisorption 

surface tension, frictional, electrostatic or any other form of adhesion." J.A. Hersey, Ordered 

Mixing: A New Concept in Powder Mixing Practice. 11 Powder Technology 41, 41 (1975). 

22 

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claim[] [language] ... can also be valuable sources of enlightenment as to the meaning o a 

claim term.")( quoting Phillips, '415 F .3d at 1314) Thus, for purposes of claim constructi n, 

the more appropriate focus is on the components constituting the ordered mixture consistent with 

the language of claim 1. I reject Plaintiffs construction. 

Defendant's construction attempts to identify components that make up the order d 

mixtures. According to Defendant, the ordered mixture consists of carrier particles and adhere 1t 

particles of an active pharmaceutical agent, and may sometimes consist of a bio/mucoadhesi 'e 

agent. In response, Plaintiff controverts, in its briefs filed in connection with 

construction, that the carrier particles and the bio/mucoadhesive are the only 

components of the ordered mixture described by the '91 0 Patent. 

More specifically, Plaintiff contends that the '910 Patent requires the presence of tl e 

carrier particles and the bio/mucoadhesive in the ordered mixture, while the presence of tl e 

pharmaceutically active agent is optional. Plaintiff cites an embodiment from the '9 0 

'specification, which Plaintiff interprets as instructive that the active agent is replaced by t e 

bio/mucoadhesive in the ordered mixture. Plaintiff only references one sentence from t e 

preferred embodiment, but the full passage provides: 

In order for the pharmaceutical composition of the invention to function properly 

when a bio/mucoadhesion promoting agent is added thereto, this agent must be 

positioned at the surfaces of the carrier particles. The bio/mucoadhesion 

promoting agent can then be admixed to the carrier particles in several ways. In a 

preferred embodiment of the invention, a fine particulate quality of the 

bio/mucoadhesion promoting agent is mixed together with the course carrier for a 

sufficient time to produce an ordered mixture, where the finer particles exist as 

discrete primary particles adhered to the surfaces of the carrier particles. Thus, 

the bio/mucoadhesion promoting agent is admixed in the same way as the active 

compound described in European patent No. 0 324 725. 

'910 Patent, col. 5, ll. 53-65. 

23 

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Plaintiff insists that the active agent is not required to be in the ordered mixture, and it 

reasons that the embodiment teaches that the active agent can be replaced by t e 

bio/mucoadhesive in the ordered mixture because it instructs that the bio/mucoadhesive shou d 

be mixed in the same way the active agent is incorporated into the ordered mixture in t e 

Nystrom Patent. However, the Nystrom Patent never addresses the presence of a 

bio/mucoadhesive agent. The absence of that agent is, in fact, what differentiates the Nystro1. 

Patent from the '91 0 Patent. Also, the Nystrom Patent does not contain any embodiments th t 

would replace the active agent with another substance. Thus, Plaintiffs attempt to incorpora e 

a limitation into claim 1, which it contends is based on the prior art, is not persuasive. 

Additionally, Plaintiffs interpretation of the preferred embodiment from the '91 0 Pate t 

IS flawed. Plaintiff takes a sentence that discusses purely a method of preparation a d 

improperly construes it to place a limitation on a claim. The passage cited by Plaintiff simp y 

states that the bio/mucoadhesive agent can be mixed in the same manner as the active compou d 

in the Nystrom Patent. The Court does not interpret that passage to mean that t e 

bio/mucoadhesive replaces the active compound in the ordered mixture. Even more damning, t e 

language of the '910 Patent belies Plaintiffs construction. As to the active agent, claim 1 clear y 

states that the ordered mixture consists of microparticles of the active agent adhered to t e 

carrier particles. See '910 Patent, col. 10, 11. 34-41 ("ordered mixture of microparticles of 

least one pharmaceutically active agent adhered to the surfaces of carrier particles . . . " . 

Nothing in '91 0 Patent describes an ordered mixture without the active agent. See Unithen 

Food Sys. v. Swift-Eckrich, Inc., 375 F.3d 1341, 1351 (Fed. Cir. 2004)("[where] the plain 

language of a patent claim is clear and uncontradicted by anything in the written description r 

the figures, the district court should not rely upon the written description, the figures, or the 

24 

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prosecution history to add limitations to the claim. Under such circumstances, relying on t e 

written description and prosecution history to reject the ordinary and customary meanings oft e 

words themselves is impermissible."). Accordingly, the Court rejects Plaintiffs contention th t 

the active agent is not necessary to form the ordered mixture in claim 1. 

Having found that the active agent is a part of the ordered mixture and that there is o 

dispute that the carrier particles are -also a part of the mixture, the Court considers whether t e 

bio/mucoadhesive agent is another component. A plain reading of claim 1 gives two possib e 

interpretations for the components of the ordered mixture. The first, which is Defendant s 

proposed construction, includes the active agent and the carrier particles in the ordered mixtur . 

This interpretation is supported by a close examination of the comma placement in claim , 

which can be broken into three clauses: (1) "a pharmaceutical composition for the treatment ( f 

acute disorders by sublingual administration," (2) "comprising an essentially water-free, ordere 

mixture of microparticles of at least one pharmaceutically active agent adhered to t e 

surfaces of carrier particles, said particles being substantially larger than said microparticl s 

and being water soluble," (3) "and a bioadhesion and or/mucoadhesion promoting agent main y 

adhered to the surfaces of carrier particles." '91 0 Patent, col. 10, ll. 42-49 (emphasis added . 

Broken down in this manner, clause 2 describes all the required components to form an order d 

mixture en~ompassed by this claim, and the bio/mucoadhesive is not listed in clause 2. Thu , 

when claim 1 is read in this light, the claimed pharmaceutical composition consists of an order d 

mixture of microparticles of the active agent adhered to the carrier particles and, additionally, a 

bio/mucoadhesive. 

There is, however, as proposed by Plaintiff, another interpretation of claim 1 that also 

makes grammatical sense. In this version, every substance listed after the "ordered mixture" is a 

25 

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component of that mixture. The commas, in this interpretation, are not used to separ te 

components; rather, they offset phrases describing the characteristics of the components. 

another possible way to read claim 1 is that the ordered mixture consists of microparticles oft e 

active agent, carrier particles, and a bio/mucoadhesive. 

Attempting to determine which interpretation is correct, the Court examines the'9 0 

Abstract, which states: 

The composition comprises an essentially water-free, ordered mixture of at least 

one pharmaceutically active agent in the form of microparticles which are adhered 

to the surfaces of carrier particles which are substantially larger than the particles 

of the active agent or agents, and are essentially water soluble, in combination 

with the bioadhesion and/or mucoadhesion promoting agent. 

'91 0 Patent Abstract. The language of the abstract mimics the language of claim 

significant difference is the "and" before the phrase "bioadhesion and/or mucoadhesi n 

promotion agent" in claim 1 is replaced by "in combination with" in the Abstract. However, t is 

parallel language could be consistent with either of the proposed readings of claim 1 and hence, 

gives little guidance as to the proper interpretation. 

I now tum to the preferred embodiments. A review of the '910 Patent's embodimen s 

reveals that the ordered mixture includes the bio/mucoadhesive agent, albeit t e 

bio/mucoadhesive is incorporated in the mixture differently. In fact, in that connection, t e 

specification specifically discusses a preferred particle size for the bio/mucoadhesive when it · s 

in an ordered mixture ("When the particles of this agent are to be mixed with the carrier particl s 

to form an ordered mixture, their size suitably is then below 10 J.tm"). '91 0 Patent, col. 6, ll. 2 -

30. While a reading of claim 1 where the bio/mucoadhesive is not included in the order d 

mixture can make sense grammatically, a claim construction that excludes a preferr d 

embodiment is heavily disfavored. Vitrionics, 90 F.3d at 1583. And, Defendant's propos d 

26 

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written construction for the term "ordered mixture" - which is only composed of the carri r 

particles and the pharmaceutical active agent - excludes the bio/mucoadhesive agent. As sue , 

the Court cannot accept a construction· of "ordered mixture" that does not include 

bio/mucoadhesive in the ordered mixture because it would exclude the embodiments. 

I further note that while Defendant does not explicitly endorse it in its proposed writt n 

construction, it concedes, in its briefing, that an ordered mixture may sometimes include a 

bio/mucoadhesive. Such a relaxation of construction would not exclude the embodiments, s 

distinguished from Defendant's proposed construction. Given this concession, the inquiry th n 

is whether an ordered mixture, according to claim 1, must contain the bio/mucoadhesive agent. 

In that regard, as discussed previously, the language of claim 1 - which strongly suggests t e 

presence of a bio/mucoadhesive agent in the ordered mixture - can be interpreted in two differe t 

ways. Thus, since the intrinsic evidence does not provide the Court with sufficient guidance n 

this point, consultation of the extrinsic evidence is helpful. The '910 Patent inventors author d 

two articles in 2003 which discuss the "ordered mixture" they invented and claimed in the paten . 

Specifically, they describe how to formulate an ordered mixture that includes a 

bio/mucoadhesive agent. For example, one of the articles explains that 

A new approach to the problem has been suggested by Bredenberg and Nystrom 

(2003), who found that by dry mixing, carrier particles could be partially covered 

with fine dry particles of a bioadhesive material to form an interactive mixture. 

These small, bioadhesive units could then replace the large, bioadhesive, single 

unit (tablet or disc). It is then theoretically possible to add the active substance to 

the surface of these carrier particles, resulting in ordered units comprising coarse 

particles carrying both bioadhesive component and drug. 

See Peppas Decl., Ex. 16 at ORM_00001223 (emphasis added). Based on those articles, t e 

focus of the '91 0 inventors was on ordered mixtures comprised of the carrier particles, 

pharmaceutical active agent and the bio/mucoadhesive. 

27 

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After evaluating the intrinsic and extrinsic evidence, the Court determines that, in t e 

context of the '91 0 Patent, both the pharmaceutically active agent and the bio/mucoadhesive e 

components of the ordered mixture for purposes of claim 1. Accordingly, the Court rejects bo h 

parties' constructions, and instead, adopts the following construction for "ordered mixture": 

mixture of microparticles of at least one pharmaceutically active agent adhered to the surfaces f 

carrier particles and a bioadhesive and/or mucoadhesive promoting agent." 

D. Microparticles of least One Pharmaceutically Active Agent 

The parties dispute the meaning of "microparticles of at least one pharmaceutically acti e 

agent" in claims 1 and 9. In general terms, the two parties differ as to whether the phrase limi s 

the size of the pharmaceutically active agent particles in the ordered mixture. Specificall , 

Defendant contends that the claim language places an upper limit of 24 microns on the size 

the active ingredient particles. In contrast, Plaintiff proposes a broad construction that contai s 

no size limitation.7 

Defendant's construction, with which I do not agree, is based on two portions of the '91 0 

Patent's specification. The first describes the preferred and maximum particle size (1 0 and 4 

microns, respectively) when fentanyl is used as the active agent. See '91 0 Patent, col. 7, 11. 4- . 

Indeed, the language setting forth the maximum size of fentanyl merely illustrates the gener 1 

characteristic of fentanyl, and therefore, it cannot impose a limitation on the patent claims. S ~ 

Advanced Cardiovascular Sys. v. Scimed Life Sys., 261 F.3d 1329, 1339 (Fed. Cir. 2001 . 

Moreover, the specification simply describes a preferred size for fentanyl, which is only one f 

7 Prior to the Markman hearing, Plaintiff proposed a construction for the term "microparticles of 

at least one pharmaceutically active agent" as "a drug, in particulate form, that is used for the 

treatment of medical condition. Pharmaceutically active agent induces zolpidem and its 

pharmacologically acceptable salts and specifically zolpidem tartrate." During the hearing, 

Plaintiff abandoned the second phrase from its proposed construction. Markman Hr' g Tr. 51. 

28 

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many possible active pharmaceutical agents. See Id., col. 7, ll. 7-10. In general, based on t e 

'910 Patent, the size of the active agent will vary depending on the chemical composition oft e 

agent used in the ordered mixture. In fact, the specification of the '910 Patent details a multituc e 

of active agents that could be used in the invention. See Id. Since the invention is not limited o 

use of fentanyl, the claims should not be limited to the preferred size for fentanyl particles. F r 

these reasons, I find that this portion of the specification is simply providing an example of a 

preferred particle size when using a specific active agent, not limiting the scope of the inventio . 

Another passage from the '91 0 Patent specification, referenced by Defendant, discuss s 

the invention's improvement on the prior art. Specifically, the passage states: 

The possibility to use ordered mixtures for sublingual administration, where the 

volume of liquid is available as solvent is limited to a few milliliters, has not been 

considered as a feasible approach. It was therefore unexpected that the present 

form of a solid dosage form preparation and administration route gives positive 

and useful results. In such an ordered mixture, the active agent or agents have a 

mean particle size below 10 microns. 

Id., col. 3, ll. 44- 52. According to Defendant, this passage indicates that the inventor's o" n 

conception of the invention has a size limitation. In addition to the 24 maximum micron si e 

limitation, Defendant also proposes that the '91 0 Patent contains a 10 micron size limitatio 1. 

The Court disagrees. As stressed by Plaintiff, the '91 0 Patent already contains a specific si· e 

limitation for the pharmaceutically active agent in claim 2.8 In that respect, the invent r 

expressly acknowledged the importance of a size limitation in claim 2. It follows logically that if 

a size limitation was necessary for claims 1 and 19, those limitations would have been include , 

similar to the limitations imposed in claim 2. In that connection, in the specific case f 

8 Claim 2 states, "A composition according to claim 1, wherein the microparticles of said active 

agent or agents have a weight based mean diameter or less than 10 p.m." '910 Patent, col. 10, ll. 

51-53. 

29 

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independent/dependent claims, a dependent claim places an additional limitation on the terms f 

the independent claim on which it depends. See generally, 35 U.S.C. § 114, ~ 4 ("[A] claim n 

dependent form shall contain a reference to a claim previously set forth and then specify a furth r 

limitation of the subject matter claimed"). Based on that principle, claim 2, the dependent clai 

limits the terms of claim 1 by adding a size limitation of 10 microns for the microparticles oft e 

pharmaceutically active agent. Hence, Claim 2 would be rendered superfluous if the terms < f 

claim 1 would also contain a numerical size limitation. 

Moreover, as mentioned previously,. Defendant attempts to use the above-quoted passa e 

in the specification apparently to show the inventor's intention to limit the active agent partie e 

size to 10 microns. However, applying that passage to limit claim 1 would violate the doctri e 

of claim differentiation. The doctrine of claim differentiation teaches that if different words a e 

used in separate claims, they have different meanings and scopes. Karlin Tech. Inc. v. Sur ic 1 

Dynamics, Inc., 177 F.3d 968, 971-72 (Fed. Cir. 1999). That doctrine does not apply if there is 

only one possible interpretation of the claim. Laitram Corp. v. Rexnord, Inc., 939 F.2d 153 , 

1538 (Fed. Cir. 1991). Here, the Court cannot interpret claim 1 in such a way thatwould requir ·, 

essentially, nullifying claim 2. Stated differently, "microparticles of at least o e 

pharmaceutically active agent" cannot mean particles of less than 10 microns because that · s 

precisely what claim 2 describes. Accordingly, Defendant cannot support its construction wi h 

this passage since doing so would violate the doctrine of claim differentiation. 

While Defendant is mistaken in including specific size limitations in its construction th t 

would, inter alia, make claim 2 superfluous, Plaintiff is equally mistaken in providing o 

limitation to the term "microparticles." Plaintiffs proposed construction of the term -- "a dru , 

in particulate form, that is used for the treatment of medical condition" -- ignores the meaning f 

30 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 30 of 38 PageID: 9815
"microparticles." It is the Court's responsibility to evaluate the proposed constructions, and aft r 

evaluating all the evidence, state the meaning of the claims. Exxon Chern. Patents Inc. ·~ 

Lubrizol Corp., 64 F.3d 1553, 1556 (Fed. Cir. 1995). The Court is not restricted by the propos d 

constructions. Id. I note that, scientifically, the term microparticles refers to a partie e 

measuring between 1 and 1000 microns. 9 Defendant's expert correctly recognizes that this ten 

distinguishes microparticles from larger (macroparticles) and smaller (nanoparticles) siz d 

particles. See Peppas Decl. ,-r,-r 86. More colloquially, the prefix "micro" refers to anything th t 

lS very small. Micro Definition, Dictionary.con _, 

http://dictionary.reference.com/browse/micro?s=t (last visited March 27, 20 14). Regardless < f 

whether the technical or common definition is used, the prefix "micro" -- by definition -

suggests the pharmaceutically active agent is restricted in size, albeit not by any specific nume c 

limitations. 

For the forgoing reasons, the Court rejects the constructions proposed by Plaintiff a d 

Defendant. After considering the intrinsic evidence, I adopt the following construction: " 

pharmaceutically active agent, in micro-particulate form, which is used for the treatment f 

medical conditions." 

E. Adhere to Surfaces 

The parties dispute the meaning of "adhered to the surfaces." Neither party supports ts 

construction with language from the '91 0 Patent. Plaintiff proposes a construction that defin s 

"adhered" and "surfaces" according to their commonly used meanings: "active agent held at tl e 

outside part or layer of carrier particles." Plaintiff supports its proposed construction wi h 

9 See, generally, Bureau International des Poids et Mesures [BIPM], International System of 

Units, gth Ed. (2008). 

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Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 31 of 38 PageID: 9816
dictionary definitions of the terms. 10 Defendant proposes a construction that defines "adhere" · s 

"to bind," which reads "binding to the surfaces." Defendant claims that its construction ·s 

supported by a passage in the Nystrom Patent that uses the language "in which the small r 

particles adhere or bind to the surfaces of the larger carrier particles." See Nystrom Patent, c l. 

1, 11. 21-22 (emphasis added). 

The language of the '910 gives little guidance for defining the term "adhere to surfaces" 

While Defendant supports its construction with a passage from the prior art, a type of intrins c 

evidence, see Vitrionics, 90 F. 3d at 1583, that passage provides little guidance as to the meani 

of the term "adhere." Indeed, the prior art specifies that the smaller particles "adhere or bind" o 

the carrier particles, see Nystrom Patent, col. 1, 11. 21-22, which signifies that these two tern s 

may be used interchangeably in that claim. Using those two terms interchangeably does not sh d 

light on the meaning of "adhere." Consequently, contrary to Defendant's position, "bind" do s 

not define "adhere" in the prior art, nor does it in the '910 Patent. Additionally, as noted y 

Plaintiffs expert, "bind" could imply that the pharmaceutically active agent is connected to t e 

carrier particles through a chemical reaction. See Peppas Dec I. ,-r 102. The '91 0 Pate t 

specification refers to the components of the invention as being "mixed" together, not react d 

together. See '910 Patent, col. 6, 1. 27. Therefore, Defendant's usage of the word "bind" cou d 

be incongruent with the specification of the Patent. The parties do not refer to any other intrins · c 

evidence to support their respective positions, and the Court has not independently found a y 

intrinsic evidence helpful in this context. 

10 Adhere is defined as "to stick together; become fastened together. Physics. of two or more 

dissimilar substances in contact, to be held together by molecular forces acting at the surface." 

Academy Press Dictionary of Science and Technology (1992). Surfaces is defined as "[t]he 

outer or topmost boundary of an object." ld. 

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Lacking any guidance from the intrinsic evidence, it is appropriate to consult extrins c 

evidence, such as dictionaries, to determine the scope of the claim. See Vitronics, 90 F.3d tt 

1583; Johnson, 175 F.3d at 989. According to a dictionary definition, adhere means "to st y 

attached; stick fast; cleave." Adhere Definition, Dictionary.co !, 

http://dictionary.reference.com/browse/adhere?s=t (last visited March 27, 2014). I find that t e 

ordinary meaning of the term adhere provides a clearer and more accurate picture of t e 

interactions present between the active agent and the carrier particles. Accordingly, the Court 

construes the term "adhere to the surfaces" as "active agent attached at the outside part or lay ·r 

of carrier particles." 

F. Substantially Larger 

Similar to their dispute over the construction of "microparticles," the parties disagree c n 

whether "substantially larger" refers to a specific size _limitation. Plaintiff posits th tt 

"substantially" means there is an appreciable difference between the size of the carrier partie! s 

and the pharmaceutically active agent. On the other hand, Defendant, basing its construction c n 

the proposed size limitation for the microparticles of the pharmaceutically active agent, sugges s 

that "larger" means greater than 24 microns. Defendant further contends that "substantial y 

greater than 24 microns" calls for the carrier particles to be at least two times larger than t e 

microparticles of the pharmaceutically active agent. To support that reasoning, Defendant poin s 

to a preferred embodiment (Example 1 ), which specifies that the carrier particle size should 1 e 

between 250 and 450 microns. See ld., col. 8, 1. 12. Additionally, Defendant notes that t e 

embodiment details a preferred carrier particle size. See Id., col. 4, ll. 29-34. ("Preferably t e 

carrier particle size is from 50 to 750 microns, and more preferably from 100 to 600 micron ). 

I d. Combining these portions of the '91 0 Patent, along with their proposed size limitation for tl e 

33 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 33 of 38 PageID: 9818
microparticles, Defendant concludes that "substantially larger" requires the carrier particles to e 

at least two times the size of the microparticles. 

As previously held, Defendant's position that the '910 Patent limits the size of the acti e 

agent microparticles to 24 microns is misplaced. For similar reasons, the Court cannot acce] t 

Defendant's construction of "substantially larger" because it is based on the same flaw d 

restriction. Furthermore, there is no specific size restriction for the carrier particles in the '91 0 

specification. The embodiments used by Defendant to substantiate its construction are preferr 4 

sizes, not absolute limitations. Also, Defendant's reliance on the preferred embodiments to li :it 

claim terms is strongly discouraged. Phillips, 415 F.3d at 1323. Therefore, claims 1 and 19 

should not be limited to the carrier particle sizes detailed in Example 1, as proposed 

Defendant. Accordingly, the Court rejects Defendant's construction of"substantially larger." 

Although there is no specific numerical limitation for the size of the carrier particles, it is 

clear from the specification of the '91 0 Patent that there needs to be a significant size differen e 

between the carrier particles and the microparticles of the pharmaceutically active ager t. 

Ptaintiffs proposed construction provides no guidance as to what "substantially" means; rath 

it simply replaces the term· "substantially" with "appreciably." While it is inappropriate o 

replace the term "substantially" with any numeric restrictions, I also find that substituting o e 

undefined term with another does not provide further clarity. In that regard, I do not find that tl e 

term "substantially" needs to be replaced by any other terms with similar meanings. Rather, it is 

apparent from the context of the claim what "substantially" means - its plain and ordina y 

meaning suffices - and therefore, that term need not be construed. See MeadW estVaco Co . . 

Rexam Beauty & Closures, Inc., 731 F.3d 1258, 1302 (Fed. Cir. 2013)(explaining that wh n 

34 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 34 of 38 PageID: 9819
there is no special definition for a term in a patent, the term should be afforded its plain a d 

ordinary meaning). 

G. Treatment 

The parties dispute whether "treatment" refers to a specific outcome when dealing wi h 

an acute condition, or, "treatment" refers more generally to different forms of medical car·. 

Plaintiff contends that "treatment" does not need construction and the Court should afford t e 

term its ordinary meaning. According to Plaintiff, a dictionary meaning of "treatment" is "t e 

application of medicines, surgery, psychotherapy, etc. to a patient or to a disease or symptoms " 

On the other side of the ledger, Defendant proposes that "treatment" means "control [the acu e 

disorder]." Defendant supports its construction with a passage from the background section f 

the '910 Patent, which states: "Presently available oral, rectal or sublingual formulations ha,ie 

relatively lengthy onset times or erratic absorption characteristics that are not well-suited o 

control acute disorders." '91 0 Patent, col. 1, ll. 31-34 (emphasis added). 

First, I find Defendant's proposal unnecessarily limits the claims in the '910 Patent. 

passage, cited by Defendant, recognizes that the prior art did not efficaciously administer a dn g 

to successfully control acute disorders. In that regard, the '91 0 Patent teaches a method f 

administration to improve that efficacy. Indeed, the term "control" means "to hold in check; o 

eliminate." Control Definition. 

http://dictionary.reference.com/browse/control?s=t (last visited March 27, 2014). Whether t e 

invention would successfully "control" an acute disorder will depend on a number of factm s, 

including the efficacy of the drug. In other words, although using the method of the inventi n 

along with an effective pharmaceutical agent may result in· controlling an acute disorder, t at 

result is not a foregone conclusion in the context of the '910 Patent; therefore, using the wo d 

35 

Case 3:11-cv-03788-FLW-LHG Document 191 Filed 03/31/14 Page 35 of 38 PageID: 9820
"control" limits the scope of the patent claims. See, e.g., Hone ell Inc. v. Victor Co. of Ja a h 

LTD., 298 F.3d 1317, 1325-26 (Fed. Cir. 2002) ("the inventor did not intend to limit the scope f 

the claim to structures that would solve both of the prior art problems identified in t e 

background section of the written description of the '50 1 patent"). Consequently, the Court 

rejects the Defendant's proposed construction of "treatment." 

In light of the fact that the purpose of the invention is to create an effective method f 

administration, and the '910 Patent language does not indicate that "treatment" has any speci tl 

meaning in this context, the Court finds that the ordinary meaning of the word is sufficient for i s 

construction. However, I find the medical definition of "treatment" more appropriate than t1 e 

definition proposed by Plaintiff. In a medical context, "treatment" is defined as "administratic n 

or application of remedies to a patient or for a disease or an injury." Treatment Definitio 1. 

Dictionary.com, http://dictionary.reference.com/browse/treatment?s=t (last visited March 27, 

2014). Using that definition, the Court construes "treatment" in Claims 1 and 9 as a 

pharmaceutical composition for the "administration or application of remedies for ac te 

disorders." 

H. Effective Amount 

Finally, the parties disagree on whether "effective amount" requires "control" of t e 

acute disorder. Plaintiff suggests the following construction: "An amount that elicits a 

therapeutic response." It supports this construction with language from the '910 Patent stati 

that the invention was intended to "giv[ e] rise to pharmacologically effective plasma levels" f 

an active agent. See '91 0 Patent, col. 2, 11. 26-31. Plaintiff also contends that the "amount that 

elicits a therapeutic response" is what skilled persons would appreciate to be the ordina y 

meaning of "effective amount." 

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In response, consistent with its proposal of "treatment", Defendant construes "effecti' e 

amount" as the "amount of active agent sufficient for treatment of an acute disorder is in t e 

form of microparticles adhered to the surfaces of carrier particles." Defendant's constructi n 

includes the term "treatment," and it defines "treatment" based on its previous construction < f 

the term ("control [the acute disorder]"). However, since the Court has rejected Defendant s 

proposed construction of "treatment," for the same reasons, the Court rejects Defendant s 

proposal with respect to the term "effective amount." 

Rather, I find Plaintiffs construction sound. In support of its construction, Plaintiff cit s 

a case where the court declined to construe "therapeutically effective amount" because i s 

meaning would have been apparent to skilled persons in the art. AstraZenaca AB v. Dr. Reddy· s 

Labs., Ltd., No. 05-5553(JAP), 2010 WL 1981790, at *27 (D.N.J. May 17, 2010). Like the co rt 

in that case, the Court here declines to construe "effective amount" beyond its ordinary meani g. 

( 

According to Plaintiff, the ordinary meaning of "effective amount" is "an amount that elicits a 

therapeutic response." Considering that Defendant's own expert agrees that persons skilled · n 

the art would recognize that "effective amount" means "an amount that elicits a therapeu ic 

response" (See Elder Tr, 43:8-1 0), the Court accepts Plaintiffs construction. 

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CONCLUSION 

The following Chart represents the Court's construction of the disputed claim terms: 

DATED: 3/3112014 

A water content that does not prevent the bio/mucoadhesion 

promoting properties in a pharmaceutical composition for 

sublingual administration. 

A substance that is effective in making the active agent adhere to 

the oral mucosa. 

Microcrystalline Cellulose ("MCC") is not a bioadhesion and/or 

mucoadhesion promoting agent. 

A pharmaceutically active agent, in micro-particulate form, that i 

used for the treatment of medical conditions. 

Active agent attached at the outside part or layer of carrier 

particles. 

Substantially larger 

A mixture of microparticles of at least one pharmaceutically 

active agent adhered to the surfaces of carrier particles and a 

bioadhesive and/or mucoadhesive promoting agent. 

Administration or application of remedies for acute disorders. 

An amount that elicits a therapeutic response 

Is/ Freda L. Wolfson 

Freda L. Wolfson 

United States District Judge 

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