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`US Patent No. 7,897,080
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`CLAIMS APPENDIX - ALL INDEPENDENT CLAIMS
`......................................... CA - All Independent Claims - page
`
`CLAIMS APPENDIX- ALL CLAIMS .......................................... CA-1
`
`CLAIM AMENDMENTS AFTER ACP- NOT ENTERED .......... CA-Not Entered Page-l
`
`EVIDENCE APPENDIX ...................................................... EA-i
`
`Declaration of B. Arlie Bogue, Ph.D. Under 37 C.F.R. § 1.132, dated March 13, 2013
`("Bogue Declaration I") .. .............................................. EA-1
`
`Declaration of B. Arlie Bogue, Ph.D. Under 37 C.F.R. § 1.132, executed August 29,
`2013 ("Bogue Declaration II") .. ......................................... EA-2
`
`RELATED PROCEEDINGS APPENDIX ...................................... RJ>A-1
`
`CERTIFICATE OF SERVICE. .............................................. CoS- 1
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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`TABLE OF AUTHORITIES
`
`CASES
`
`In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) ................................. -41-
`
`In re Royka, 490 F 2d 981, 180 USPQ 580 (CCPA 1974) ............................ -35-
`
`Institut Pasteur & Universite Pierre et Marie Curie V Focarino, Nos. 2012-1485, 2012-1486,
`2012-1487 (Fed. Cir. December 30, 2013) ........................................ -18-
`
`Leo Pharmaceutical Products, Ltd. v. Rea, 726 F. 3d 1346 (Fed. Cir. 2013) ..... -28--32-, -41-,
`-42-, -53-, -55-
`
`Peters v. Active Mfg. Co., 129 US 530 (1889) ...................................... -19-
`
`STATUTES
`
`35 U.S.C. § 103 ............................................................. -35-
`
`RULES &MPEP
`
`MPEP § 2112 IV ............................................................ -41-
`
`MPEP § 2143 ............................................................... -35-
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`-v-
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`US Patent No. 7,897,080
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`APPELLANT'S APPEAL BRIEF
`
`I.
`
`Statement of the Real Party in Interest
`
`MonoSol Rx, LLC, owner ofU.S. Patent No. 7,897,080 (the" '080 Patent"), is the
`
`real party in interest for Appellant.
`
`II.
`
`Related Appeals and Interferences
`
`Other than as noted below, Appellant is not aware of any related appeals, interferences or
`
`judicial proceedings which will directly affect or be directly affected by or have a bearing on the
`
`Board's decision in the pending appeal.
`
`On November 2, 2010, Appellant commenced an action, for patent infringement of
`
`several patents it owns, namely, U.S. 7,824,588 (the" '588 Patent"), U.S. 7,357,891 (the" '891
`
`Patent") and U.S. 7,425,292 (the" '292 Patent"), against Third Party Requestor, inter alia, in the
`
`U.S. District Court for the District ofNew Jersey, captioned MonoSol Rx, LLC v. BioDelivery
`
`Sciences International, Inc., MEDA Pharmaceuticals, Inc. and Aveva Drug Delivery Systems,
`
`Inc., 10-cv-5695 ("the Litigation").
`
`While the Litigation was ongoing, Third Party Requester first requested inter partes
`
`reexamination of the '588 Patent (95/001,753, filed September 12, 2011); and then requested ex
`
`parte reexamination of the remaining patents in the Litigation, the '891 Patent (90/012,098, filed
`
`January 20, 2012) and the '292 Patent (90/012,097, filed January 20, 2012). After filing all of its
`
`reexamination requests, Third Party Requestor, inter alia, moved the District Court to stay the
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`Litigation and on March 7, 2012, the Court stayed the Litigation and the stay is still in effect.
`
`The '891 Patent and the '292 Patent successfully exited reexamination with reexamination
`
`certificates, leaving the '588 Patent inter partes reexamination pending and currently on appeal to
`
`the PTAB.
`
`On June 12, 2013, Third-Party Requestor, improperly petitioned for Inter Partes Review
`
`of the '891 Patent (IPR2013-00316) and the '292 Patent (IPR2013-00315) which had recently
`
`successfully exited reexamination. The PTAB denied both petitions on November 13, 2013, as
`
`untimely.
`
`Third-Party Requester has also requested inter partes reexamination of two additional
`
`patents of Appellant, namely, the '080 Patent and U.S. 7,666,337 (the" '337 Patent") (Control
`
`No. 95/002,171). The '337 Patent reexamination is currently on appeal to the PTAB. All five
`
`(5) reexaminations were assigned to the same examiner, Alan D. Diamond.
`
`Several ANDA-based actions have been recently commenced for patent infringement
`
`arising from the submission of ANDAs regarding' 150 Patent, inter alia., in the U.S. District
`
`Court for the District of Delaware. The '150 Patent is a divisional of the application for the
`
`'337 Patent, of which the '080 Patent is a continuation. On August 20, 2013, Reckitt Benckiser
`
`Pharmaceuticals, Inc. ("RBP"), RB Pharmaceuticals Limited ("RBP UK") and Appellant
`
`commenced their patent action against Par Pharmaceutical, Inc., IntelGenX Technologies Corp.,
`
`and LTS Lohmann Therapy Systems Corp., captioned Reckitt Benckiser Pharmaceuticals, Inc.,
`
`et al. v. Par Pharmaceutical, Inc., et al., 1:13-cv-01461. On October 8, 2013, RBP, RBP UK
`
`and Appellant commenced their patent action against Watson Laboratories, Inc. and Actavis,
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`US Patent No. 7,897,080
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`Inc., captioned Reckitt Benckiser Pharmaceuticals, Inc., et al. v. Watson Laboratories, Inc. , et
`
`al., 1:13-cv-01674. On December 6, 2013, RBP, RBP UK and Appellant commenced their
`
`patent action against Alvogen Pine Brook, Inc. and Alvogen Group, Inc., captioned Reckitt
`
`Benckiser Pharmaceuticals, Inc., et al. v. Alvogen Pine Brook, Inc., et al., 1:13-cv-02003.
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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`III.
`
`Status of Claims
`
`Claims 1-299 were issued in the '080 Patent; these claims, subject to reexamination, were
`
`rejected in the Office Action dated November 29, 2012 ("Office Action").
`
`In Patentee's
`
`Response to Office Action dated March 13, 2013 ("Patentee's ROA''), claims 12, 16, 91, 95, 173,
`
`177,254,255,257,272,273,275,290,291, and 293 were canceled and claims 300 through 318
`
`were added.
`
`In Appellant's Response to Action Closing Prosecution dated September 3, 2013,
`
`Appellant attempted to amend claims 1, 82, 161 and 315-318 in an effort to advance the
`
`prosecution of the reexamination and to address rejections made by the Examiner based on new
`
`references. See Action Closing Prosecution ("ACP"), pp. 3, 48-51. In the RAN, the Examiner
`
`refused to enter the claim amendments, see infra.
`
`After the RAN, the following claims are pending and currently stand rejected: claims:
`
`1-11, 13-15, 17-90, 92-94, 96-172, 174-176, 178-253, 256, 258-271, 274, 276-289, 292 and
`
`2 94-318. Appellant is appealing each and every claim rejected and all the grounds therefor.
`
`IV.
`
`Status of Amendments
`
`In the RAN, the Examiner, in connection with Appellant's September 3, 2013 Reply to
`
`the July 31,2013 Action Closing Prosecution ("ACP"), refused entry of Appellant's amendment
`
`to claims 1, 82, 161 and 315-318 (see attached CA-Not Entered).
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`US Patent No. 7,897,080
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`V.
`
`Summary of Claimed Subject Matter
`
`The present invention is directed to novel and non-obvious processes for manufacturing
`
`pharmaceutical and bioactive active containing films, suitable for commercialization and U.S.
`
`Food and Drug Administration ("FDA") approval (i) where the degree of uniformity of content of
`
`active throughout a particular lot of resulting films, as well as (ii) where the degree of uniformity
`
`of content of active in dosage units taken from different lots of resulting films can also be strictly
`
`maintained through the claimed processes. Processes for such control of content uniformity are
`
`not present in the prior art.
`
`A.
`
`The Pending Independent Claims 1
`
`There are seven independent claims on appeal, i.e., claims 1, 82, 161, 315, 316, 317 and
`
`318.
`
`Claims 1, 82, 161, 315, 316, 317 and 318 are generally directed to:
`
`A process for manufacturing resulting films suitable for commercialization
`and regulatory approval, said regulatory approval including analytical chemical testing
`which meets the standards of the U.S. Food and Drug Administration relating to
`variation of an active in individual dosage units, said films having a substantially
`uniform distribution of components comprising a substantially uniform distribution
`of [a desired amount of] said active in individual dosage units of said resulting
`films, comprising the steps of:
`[Preamble- Claims 82 and 315 included bracketed limitation; claim 161 adds "film
`capable of being administered to a body suiface ".]
`
`1 The support provided herein for the claimed subject matter is by way of example only.
`Additional support for the claimed subject matter may be found throughout the issued '080
`Patent, including in the Tables, Figures, Examples, and claims of the issued '080 Patent.
`Moreover, as stated in MPEP 2258.II, "[ c ]onsideration of 35 U.S. C. 112 issues should ... be
`limited to the amendatory (e.g., new language) matter."
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`US Patent No. 7,897,080
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`(a) forming a flowable polymer matrix comprising a water-soluble polymer, a solvent
`and said active, said active selected from the group consisting of bioactive actives,
`pharmaceutical actives and combinations thereof, said matrix having a substantially
`uniform distribution of said active;
`[(a)- Claim 1 does step (a) in 2 steps (a) and (b), generally by adding active last.]
`
`(b) casting said flowable polymer matrix, said flowable polymer matrix having a
`viscosity from about 400 to about 100,000 cps;
`[(b)- Claim 1 's version is denoted step (b).]
`
`(c) controlling drying through a process comprising conveying said flowable
`polymer matrix through a drying apparatus [at a temperature of about 60 °C and
`using air currents, which have forces below a yield value of the polymer matrix
`during drying,] to evaporate at least a portion of said solvent to form a visco-elastic
`film, having said active substantially uniformly distributed throughout, within about the
`first 4 minutes by rapidly increasing the viscosity of said flowable polymer matrix
`upon initiation of drying to maintain said substantially uniform distribution of said
`active by locking-in or substantially preventing migration of said active within said
`visco-elastic film[[, such that uniformity of content in the amount of said active in
`substantially equal sized individual dosage units, sampled from different locations of said
`visco-elastic film, varies by less than 5%,]] and wherein during said drying said
`flowable polymer matrix temperature is 100 °C or less;
`[(c) - Claim 1 does not have the bracketed limitations and it is denoted as step (d); in
`claims 82 and 161 the double bracketed percent is 10%; only claim 318 has single
`bracketed limitation of 60 oc .]
`
`(d) forming said resulting film from said visco-elastic film by further controlling
`drying by continuing evaporation to a water content of said resulting film of 10% or
`less and wherein said substantially uniform distribution of active by said locking-in
`or substantially preventing migration of said active is maintained[, such that uniformity
`of content in the amount of said active in substantially equal sized individual dosage
`units, sampled from different locations of said resulting film, varies by no more than
`10%];
`[(d)- Claim 1 denotes this as step (e); claims 1, 82 and 161 do not have bracketed
`limitation; claim 318 replaces bracketed "varies by no more than 10%" with "varies by
`less than 5% ".]
`
`(e) performing analytical chemical tests for uniformity of content of said active in
`said substantially equal sized individual dosage units of said sampled resulting film, said
`tests indicating that uniformity of content in the amount of said active varies by no more
`
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`than 10% and said resulting film is suitable for commercial and regulatory approval,
`wherein said regulatory approval is provided by the U.S. Food and Drug Administration.
`[(e)- Claim 1 denotes this as step (f); claim 318 replaces "varies by no more than 10%"
`with "varies by less than 5% ".]
`
`(f) repeating steps (a) through (e) to form additional resulting films, such that
`uniformity of content in the amount of said active in said resulting film and said
`additional resulting films varies no more than 10% from the desired amount of said
`active as indicated by said analytical chemical tests.
`[(f)- only claims 82 and 315 have this step.]
`
`(f) administering said resulting film to a body surface.
`[(f) -only claim 161 has this step.]
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`US Patent No. 7,897,080
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`B.
`
`Examples of claim elements as referenced in the '080 Patent
`
`Support for claims may be found throughout the '080 Patent, including, the Abstract,
`
`Specification, Figures and Claims, for example, at:
`
`Preamble and Step (e); step (f) for claim 1: col. 3, ll. 58-60 ("the manufacture of a
`
`pharmaceutical film suitable for commercialization and regulatory approval").
`
`Step ((a); steps (a) and (b) for claim 1: col. 19, 1. 30 through col. 21, 1. 31 (actives including
`
`pharmaceutical actives, bioactive actives, and combinations thereof).
`
`Steps (b) and (c); steps (c) and (d) for claim 1: col. 6, ll. 49-52 ("These films provide a
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`non-self-aggregating uniform heterogeneity of the components within them by utilizing a
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`selected casting or deposition method and a controlled drying process."); Figures 6, 7, 8, 35 and
`
`36 and col. 14, ll. 20-25 ("drying" and "drying apparatus"); col. 11, ll. 17-19 ("Any top fluid
`
`flow, such as air, also must not overcome the inherent viscosity of the film-forming
`
`composition"); col. 11, ll. 21-23 ("yield values ... force"); col. 12, ll. 20-36, col. 13, ll. 37-38
`
`("After mechanical mixing, the film may be placed on a conveyor"); col. 29, ll. 11-13 ("As the
`
`film is conveyed through the manufacturing process, for example on a conveyor belt apparatus");
`
`col. 33, 1. 10 through col. 34, 1. 24 (example M); col. 44, 11. 9-13 ("the controlled drying process
`
`of the present invention allows for uniform drying to occur, whereby evaporative cooling and
`
`thermal mixing contribute to the rapid formation of viscoelastic film and the 'locking-in' of
`
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`uniformity of content throughout the film"); col. 6, ll. 52-60 ("Examples of controlled drying
`
`processes include ... hot air impingement across the bottom substrate and bottom heating plates .
`
`. . controlled radiation drying ... such as infrared and radio frequency radiation .... "); col. 7,
`
`lines 5 through 16 ("This may be achieved by applying heat to the bottom surface of the film ...
`
`or alternatively by the introduction of controlled microwaves to evaporate the water . . . . air
`
`currents directed at the bottom of the film should desirably be controlled"); col. 27, ll. 53-55
`
`("The temperature at which the films are dried is about 1 00°C. or less"); col. 41, ll. 49-50 ("films
`
`were dried in an oven at approximately 60° C."); col. 13, ll. 23-36 ("For instance, the films of the
`
`present invention desirably are dried for 10 minutes or less. Drying the films at 80° C. for 10
`
`minutes produces a temperature differential of about 5° C. This means that after 10 minutes of
`
`drying, the temperature of the inside of the film is 5° C. less than the outside exposure
`
`temperature. In many cases, however, drying times of less than 10 minutes are sufficient, such as
`
`4 to 6 minutes. Drying for 4 minutes may be accompanied by a temperature differential of about
`
`30° C., and drying for 6 minutes may be accompanied by a differential of about 25° C. Due to
`
`such large temperature differentials, the films may be dried at efficient, high temperatures
`
`without causing heat sensitive actives to degrade."); col. 16, 1. 62 through col. 17, 1. 3 ("The
`
`polymer plays an important role in affecting the viscosity of the film. Viscosity is one property of
`
`a liquid that controls the stability of the active in an emulsion, a colloid or a suspension.
`
`Generally the viscosity of the matrix will vary from about 400 cps to about 100,000 cps,
`
`preferably from about 800 cps to about 60,000 cps, and most preferably from about 1,000 cps to
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`about 40,000 cps. Desirably, the viscosity of the film-forming matrix will rapidly increase upon
`
`initiation of the drying process.").
`
`Step ((e); step (f) for claim 1: col. 28, 1. 66 through col. 29, 1. 6 ("It may be desirable to test the
`
`films of the present invention for chemical and physical uniformity during the film
`
`manufacturing process. In particular, samples of the film may be removed and tested for
`
`uniformity in film components between various samples. Film thickness and overall appearance
`
`may also be checked for uniformity. Uniform films are desired, particularly for films containing
`
`pharmaceutical active components for safety and efficacy reasons." ); col. 29, ll. 20 through 35
`
`("The cut film then may be sampled by removing small pieces from each of the opposed ends of
`
`the portion(s), without disrupting the middle of the portion(s) .... After the end pieces, or
`
`sampling sections, are removed from the film portion( s ), they may be tested for uniformity in the
`
`content of components between samples."); col. 32, ll. 34-41 ("An alternative method of
`
`determining the uniformity of the active is to cut the film into individual doses. The individual
`
`doses may then be dissolved and tested for the amount of active in films of particular size. This
`
`demonstrates that films of substantially similar size cut from different locations on the same film
`
`contain substantially the same amount of active."); col. 33, 1. 10 through col. 34, 1. 24 (example
`
`M); col. 15, ll. 28-43 (emphasis supplied) ("Consideration of the above discussed parameters,
`
`such as but not limited to rheology properties, viscosity, mixing method, casting method and
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`drying method, also impact material selection for the different components of the present
`
`invention. Furthermore, such consideration with proper material selection provides the
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`compositions of the present invention, including a pharmaceutical and/or cosmetic dosage form
`
`or film product having no more than a 10% variance of a pharmaceutical and/or cosmetic active
`
`per unit area. In other words, the uniformity of the present invention is determined by the
`
`presence of no more than a 10% by weight of pharmaceutical and/or cosmetic variance
`
`throughout the matrix. Desirably, the variance is less than 5% by weight, less than 2% by
`
`weight, less than 1% by weight, or less than 0.5% by weight. '')(this is the substantial uniformity
`
`of film as measured by percent difference in amount between samples where the samples differ in
`
`amount of active by 10% or less claim claim limitation a more exacting degree of uniformity
`
`than that required by, e.g., the FDA).
`
`Step (f), only claims 82 and 315: col. 2, ll. 27-46 (emphasis supplied) ("The formation of
`
`agglomerates randomly distributes the film components and any active present as well. When
`
`large dosages are involved, a small change in the dimensions of the film would lead to a large
`
`difference in the amount of active per film. If such films were to include low dosages of active, it
`
`is possible that portions of the film may be substantially devoid of any active. Since sheets of
`
`film are usually cut into unit doses, certain doses may therefore be devoid of or contain an
`
`insufficient amount of active for the recommended treatment. Failure to achieve a high degree of
`
`accuracy with respect to the amount of active ingredient in the cut film can be harmful to the
`
`patient. For this reason, dosage forms formed by processes such as Fuchs, would not likely meet
`
`the stringent standards of governmental or regulatory agencies, such as the US. Federal Drug
`
`Administration ("FDA''), relating to the variation of active in dosage forms. Currently, as
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`required by various world regulatory authorities, dosage forms may not vary more than 10%
`
`in the amount of active present. When applied to dosage units based on films, this virtually
`
`mandates that uniformity in the film be present. '') (this is the substantial uniformity within 10%
`
`of desired amount of active claim limitation).
`
`Step (f), only claim 161: col. 29, 1. 64 to col. 30., 1.2 ("In addition, the films maybe used for the
`
`administration of an active to any of several body surfaces, especially those including mucous
`
`membranes, such as oral, anal, vaginal, opthalmological, the surface of a wound, either on a skin
`
`surface or within a body such as during surgery, and similar surfaces.")
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`US Patent No. 7,897,080
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`VI.
`
`Issues to be Reviewed on Appeal
`
`A.
`
`Claim Rejections based on 35 U.S.C. § 112.
`
`1.
`
`2.
`
`Was the rejection of Claim 318 under 35 U.S.C. § 112(a) or 35 U.S.C. §
`112 (pre-AlA), first paragraph, as failing to comply with the written
`description requirement (RAN, pp. 27-28) proper?
`
`Was the rejection of Claim 318 under 35 U.S.C. § 112(b) or 35 U.S.C. §
`112 (pre-AlA), second paragraph, as being indefinite for failing to
`particularly point out and distinctly claim the subject matter which the
`inventor or a joint inventor, or for pre-AlA the applicant regards as the
`invention (RAN, p. 28) proper?
`
`B.
`
`Claim Rejections based on 35 U.S.C. §§ 102 & 103.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Were the rejections of Claims 1-11, 13-15, 17-71, 82-90, 92-94, 96-150,
`161-172, 174-176, 178-232, 243-253, 256, 258-271, 274, 276-289, 292
`and 294-318 under 35 U.S.C. § 103(a) as being unpatentable over Chen
`(RAN, pp. 29-44) proper?
`
`Were the rejections of Claims 2, 3, 32, 55, 72-81, 111, 134, 151-160, 193,
`216 and 233-242 under 35 U.S.C. §103(a) as being unpatentable over the
`combined teaching of Chen and Staab (RAN, pp. 45-48) proper?
`
`Were the rejections of Claims 317 and 318 under 35 U.S.C. § 103(a) as
`being unpatentable over the combined teachings of Chen and Arter are
`improper (RAN, pp. 48-50).
`
`Were the rejections of Claims 317 and 318 under 35 U.S.C. § 103(a) as
`being unpatentable over the combined teachings of Chen and Strobush
`(RAN, pp. 50-52) proper?
`
`Were the rejections of Claims 1-5, 10, 13-15,21,24,25, 32,44-46, 54, 55,
`59, 63-70, 72-75, 78-84, 89, 92-94,100,103,104,111,123-125,133,134,138,
`142-149, 151-154, 157-166,171, 174-176, 182, 185, 186, 193,205-207,
`215,216,220,224-231,233-236,239-242,249-252,258-260,267-270,
`276-278,285-288 and 294-318 under 35 U.S.C. § 102(b) as anticipated by
`or, in the alternative under 35 U.S.C. § 103(a) as being obvious over
`Staab (RAN, pp. 52-62) proper?
`
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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`6.
`
`7.
`
`Were the rejections of Claims 8, 9, 76, 77, 87, 88, 155, 156, 169, 170,237
`and 238 under 35 U.S.C. § 103(a) as being unpatentable over Staab are
`(RAN, pp. 62-63) proper?
`
`Were the rejections of Claims 82, 89, 90, 92, 161, 171, 172, 174,274,292,
`304-311 and 313-318 under 35 U.S.C. § 103(a) as being unpatentable over
`Le Person (RAN, pp. 63-71) proper?
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`-14-
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`TEVA EXHIBIT 1007
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`VII.
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`Prior art cited by Examiner in rejecting '080 Patent Claims
`
`The Examiner cited the following against Appellant's claims in the RAN:
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`Chen (WO 00/42992) ("Chen");
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`Staab (U.S. 5,393,528) ("Staab");
`
`Le Person ("Near infrared drying of pharmaceutical thin films: experimental
`
`analysis of internal mass transport, " Chemical Engineering and Processing, Vol.
`
`37, pp. 257-263 (1998)) ("Le Person");
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`Arter (U.S. 4,365,423) ("Arter"); and
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`Strobush (U.S. 5,881,476) ("Strobush").
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`-15-
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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`VIII.
`
`ARGUMENT
`
`A.
`
`Preliminary Statement
`
`Prior to the present invention, commercial, FDA approved, prescription pharmaceutical
`
`sublingual and lingual films for systemic delivery did not exist. Patent Owner/ Appellant
`
`MonoSol Rx is the uniquely successful pioneer in prescriptive film manufacturing. Success can
`
`be measured in part by the fact that the retail sales of Mono Sol Rx' s drug delivery films sold in
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`2012 was almost US $1,000,000,000 (One Billion US Dollars), due to their new dosage form.
`
`The '080 Patent discloses methods for the manufacture of a pharmaceutical film suitable for
`
`commercialization and regulatory approval, including FDA approval. These methods are used by
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`Appellant in the manufacture of its highly successful film products.
`
`None of the prior art drug delivery films disclose, recognize or suggest the problem of
`
`uniformity of content as recited in the claims. The prior art mentioned problems of such things
`
`as release characteristics, residence times, mechanical characteristics or adhesion characteristics,
`
`but these problems are completely different than the problem of maintaining the uniformity of
`
`content of active. The prior art incorrectly presumed that uniformity was essentially a "given"
`
`and achievable simply by providing a uniform mix of active in a carrier and forming this mixture
`
`into resultant film product. This presumption is completely erroneous. The '080 Patent
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`describes in great detail that this is not the case and offers the means to address this problem in
`
`order to produce a film with the claimed degree of uniformity.
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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`Some prior art references, e.g. Chen, refer to physical measurements and the glossy
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`appearance of the film, which the Examiner misconstrues as indicative of uniformity of content
`
`of active. Uniformity of weight and uniformity of appearance are insufficient measurements for
`
`purposes of the present claims. The information provided in such measurements cannot be relied
`
`on to determine whether the uniformity of active content has been preserved from the original
`
`mixture through film formation and processing to arrive at a resultant film product with the
`
`desired degree of uniformity. These measurements, while helpful (Appellant's own specification
`
`discuss these) are by no means dispositive as to the existence of uniformity of active content in
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`the final film product. Only by analytical chemical testing is it possible to determine the actual
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`amount of active present and hence whether uniformity of active content has been maintained
`
`during processing. This is the essence of the '080 Patent claims.
`
`It should be mentioned that the Le Person reference raised the question as to whether
`
`uniformity of films was a problem. To begin with, Le Person's films did not contain active. His
`
`inquiry was a general investigation as to what problems may exist in the film making process. Le
`
`Person posited that uniformity was a complex issue which needed addressing, but failed to fully
`
`recognize the problem articulated by Appellant's invention, and certainly failed to suggest any
`
`potential causes and solutions. At best, Le Person stands for the proposition that uniformity in
`
`non-active-containing film forming had not been achieved.
`
`The '080 Patent claims clearly recite, for the first time, those steps necessary for
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`maintaining the recited uniformity of active content throughout the film-making process, in order
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`to obtain exceptionally high degrees of uniformity of active content in the resultant film product.
`
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`Inter Partes Reexamination Control No. 95/002, l 70
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`US Patent No. 7,897,080
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`These high degrees of uniformity of active content as recited in the '080 claims exceed even the
`
`stringent requirements placed on pharmaceutical products by the FDA.
`
`B.
`
`Bogue Declarations (EA-1 & EA-2) Demonstrate Uniformity of Content and
`Locking-In in 4 Minutes2
`
`The inventive methods and processes of the '080 Patent maintain the desired uniformity
`
`of content of active by, inter alia, controlling polymer matrix viscosity and controlling the drying
`
`processes so as to form a visco-elastic film that locks-in the substantially uniform distribution of
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`active(s) during the first about 4 minutes of drying. This ability to lock-in the substantially
`
`uniform distribution of active(s) provides the novel and non-obvious processes for manufacturing
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`pharmaceutical and bioactive active containing films, suitable for commercialization and FDA
`
`approval. As noted in Bogue Declaration I, EA-1, ~ 4, one manufactured lot of resulting film can
`
`contain 2,000,000 individual dosage units. The claimed processes accomplish this feat while
`
`providing the necessary narrow ranges in variation of the amount of active in individual dosage
`
`units across all lots and even narrower ranges of uniformity of content in variation of active
`
`within a single lot of resulting film. Thus, as claimed, the '080 Patent requires a uniformity of
`
`content in amount of active (i) in individual dosage units sampled from a single lot of resulting
`
`film of 10% or less (independent claims 1, 161 and 316-318, see Appendix A, Bogue Declaration
`
`2 Importantly, the Examiner did not give the appropriate weight to Appellant's
`declarations which dealt, in part, with the non-obvious uniformity obtained by practicing the '080
`Patent in manufacturing the extremely successful commercial Suboxone® sublingual unit dose
`film products. See Institut Pasteur & Universite Pierre et Marie Curie V Focarino, Nos.
`2012-1485, 2012-1486, 2012-1487 (Fed. Cir. December 30, 2013) ("Institut Pasteur"), e.g., at
`pp. 19-21.
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`US Patent No. 7,897,080
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`I, EA -1 ), and (ii) in individual dosage units sampled from two or more lots of resulting films of
`
`+/-10% of the pre-determined desired amount (independent claims 82 and 315, see Appendix B,
`
`Bogue Declaration I, EA-1).
`
`None of Chen, Staab, Le Person, Arter and/or Strobush separately or together
`
`disclose or inherently possess the novel, non-obvious claimed degrees of uniformity of
`
`distribution of active in (1) dosage units from a single lot of resulting film and (2) dosage
`
`units from different lots of resulting film; or the novel, non-obvious degree of uniformity of
`
`content obtained by within about the first 4 minutes of initiation of drying locking-in
`
`migration of the active within said visco-elastic film.
`
`There are many typ