UNITED STATES pATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`95/002,170
`
`09/10/2012
`
`7897080
`
`1177 44-00023
`
`6418
`
`23869
`7590
`Hoffmann & Baron LLP
`6900 Jericho Turnpike
`Syosset, NY 11791
`
`03/27/2015
`
`EXAMINER
`
`DIAMOND, ALAND
`
`ART UNIT
`
`PAPER NUMBER
`
`3991
`
`MAIL DATE
`
`DELIVERY MODE
`
`03/27/2015
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
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`DRL - EXHIBIT 1039
`DRL001
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`

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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE PATENT TRIAL AND APPEAL BOARD
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Requester and Cross Appellant
`
`v.
`
`MONOSOL RX, LLC
`Patent Owner and Appellant
`
`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`Technology Center 3900
`
`Before CHUNG K. PAK, JEFFREY B. ROBERTSON, and
`RAE LYNN P. GUEST, Administrative Patent Judges.
`
`GUEST, Administrative Patent Judge.
`
`DECISION ON APPEAL
`
`This is a decision on appeal by the Patent Owner from the Patent
`
`Examiner's decision to reject pending claims in an inter partes
`reexamination of U.S. Patent 7,897,080 B2 (hereinafter the "'080 patent"). 1
`
`1 The '080 patent issued March 1, 2011, to Robert K. Yang, et al.
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`

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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`
`The Board's jurisdiction for this appeal is under 35 U.S.C. §§ 6(b ), 134, and
`
`315. We AFFIRM.
`
`I. BACKGROUND
`
`A request for inter partes reexamination under 35 U.S.C. §§ 311-318
`
`and 37 C.P.R.§§ 1.902-1.997 for the '080 patent was filed on
`
`September 10, 2012, by a Third-Party Requester, BioDelivery Sciences
`
`International, Inc. (hereinafter "Requester"). See Request for Inter Partes
`
`Reexamination 1 (hereinafter "Request"); Requester's Cross-Appeal Brief,
`
`dated March 10, 2014 (hereinafter "Req. App. Br."); Requester's
`
`Respondent Brief, dated April 10, 2014 (hereinafter "Req. Res. Br.");
`
`Requester's Rebuttal Brief, dated May 27, 2014 (hereinafter "Req. Reb.
`
`Br. "). The Patent Owner and Appellant is Mono Sol Rx, LLC (hereinafter
`
`"Patent Owner"). Patent Owner's Appeal Brief 1, dated March 10, 2014
`
`(hereinafter "PO App. Br."); Patent Owner's Respondent Brief, dated April
`
`10, 2014 (hereinafter "PO Res. Br."); Patent Owner's Rebuttal Brief, dated
`
`May 27, 2014 (hereinafter "PO Reb. Br.").
`
`The '080 patent is the subject of a litigation proceeding in the United
`
`States District Court for the Eastern District of North Carolina styled
`
`BioDelivery Sciences International, Inc. v. Reckitt Benckiser
`
`Pharmaceuticals, Inc. et al., 5-14-cv-00529 (NCED). The litigation was
`
`filed on September 20, 2014 and was stayed on December 23, 2014.
`
`2
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`
`An oral hearing was held November 5, 2014. A transcript of the
`hearing will be entered into the record in due course. 2
`
`The '080 patent is directed to a method for forming a rapidly
`
`dissolving film containing an active ingredient evenly or uniformly
`
`distributed throughout the film. '080 patent, col. 1, ll. 35-42. According to
`
`the '080 patent, "uniform distribution is achieved by controlling one or more
`
`parameters, and particularly the elimination of air pockets prior to and
`
`during film formation and the use of a drying process that reduces
`
`aggregation or conglomeration of the components in the film as it forms into
`
`a solid structure." Id., col. 1, ll. 42-47.
`
`The '080 patent originally contained claims 1-299. During
`
`reexamination, Patent Owner cancelled claims 12, 16, 91, 95, 173, 177, 254,
`
`255,257,272,273,275,290,291, and293 and added claims 300-318.
`
`Claims 1-11, 13-15, 17-90,92-94,96-172, 174-176, 178-253,256,258-271,
`
`274, 276-289, 292 and 294-318 currently are pending and rejected by the
`
`Examiner. Patent Owner appeals the rejection of all of the claims. Requester
`
`appeals the Examiner's decision not to adopt rejections of all of the claims
`
`under 35 U.S. C. § 112, first and second paragraphs, for lack of clarity, lack
`
`2 Several new arguments were raised for the first time during the oral
`hearing. The oral hearing transcript identifies some of these new arguments,
`and we note others that were not necessarily identified during the hearing.
`The parties are reminded that such new arguments are not proper and will
`not be considered. 37 C.P.R.§ 41.73(e)(l) ("At the oral hearing, each
`appellant and respondent may only rely on evidence that has been previously
`entered and considered by the primary examiner and present argument that
`has been relied upon in the briefs except as permitted by paragraph ( e )(2) of
`this section."). We will only consider arguments and evidence addressed in
`the briefs of record in this appeal.
`
`3
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`
`of enablement and/or lack of written descriptive support for several
`
`recitations within the claims.
`
`Claims 1, 82, 161, and 315-318 are the independent claims at issue in
`
`this appeal. Claims 1 and 82 are representative and read as follows (with
`
`underlining showing added language and brackets showing deleted language
`
`over the original patented claim):
`
`1. (Twice Amended) A process for manufacturing a
`resulting film 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 [making a] film having a
`substantially uniform distribution of components comprising a
`substantially uniform distribution of said active in individual
`dosage units of said resulting film, comprising the steps of:
`(a) forming a masterbatch pre-mix comprising a solvent
`and a polymer selected from the group consisting of water(cid:173)
`soluble polymers, water-swellable polymers and combinations
`thereof;
`(b) adding [an] said active, said active selected from the
`group consisting ofbioactive actives, pharmaceutical actives
`and combinations thereof, to a pre-determined amount of said
`masterbatch pre-mix to form a flowable polymer matrix, said
`matrix having a substantially uniform distribution of said
`active;
`(c) casting said flowable polymer matrix, said flowable
`polymer matrix having a viscosity from about 400 to about
`100,000 cps;
`(d) controlling drying through a process comprising
`conveying said flowable polymer matrix through a drying
`apparatus and evaporating at least a portion of said solvent from
`said flowable polymer matrix to form a visco-elastic film!.
`having said active substantially uniformly distributed
`throughout, within about the first [10]1_ minutes [or fewer] by
`rapidly increasing the viscosity of said flowable polymer matrix
`
`4
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`Appeal2014-007671
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`Patent 7,897,080 B2
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`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, wherein during said drying said flowable polymer matrix
`temperature is 100°C or less; [and]
`(e) forming [a] said resulting film from said visco-elastic
`film, wherein said resulting film has a water content of 1 0% or
`less and said substantially uniform distribution of active by said
`locking- in or substantially preventing migration of said active
`is maintained; and
`(f) performing analytical chemical tests for uniformity of
`content of said active in substantially equal sized individual
`dosage units sampled from different locations of said resulting
`film, said tests indicating that uniformity of content in the
`amount of the active varies by no more 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.
`
`Claim 82 is also representative. Claim 82 is substantially similar to
`
`claim 1 above and includes the additional step of forming multiple films:
`
`82. 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 [making
`a]film§ 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:
`(a) forming a flowable polymer matrix comprising a
`polymer selected from the group consisting of a water-soluble
`polymer, a water swellablc polymer and combinations thereof, a
`solvent and [an]said active, said active selected from the group
`consisting ofbioactive actives, pharmaceutical actives[, drugs,
`
`5
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
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`medicaments] and combinations thereof, said matrix having a
`substantially uniform distribution of said active;
`(b) casting said flowable polymer matrix, said flowable
`polymer matrix having a viscosity from about 400 to about
`100,000 cps;
`(c) controlling drying through a process comprising
`conveying said flowable polymer matrix through a drying
`apparatus and evaporating at least a portion of said solvent from
`said flowable polymer matrix to form a visco-elastic film!.
`having said active substantially uniformly distributed
`throughout, within about the first [10].4 minutes [or fewer].Qy
`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, wherein during said drying said flowable polymer matrix
`temperature is 1 00°C or less, and wherein uniformity of content
`of said active in substantially equal sized individual dosage
`units of said visco-elastic film is such that the amount of the
`active varies by no more than 1 0%; [and]
`(d) forming [a] said resulting film from said visco-elastic
`film, wherein said resulting film has a water content of 1 0% or
`less and said substantially uniform distribution of active by said
`locking-in or substantially preventing migration of said active is
`maintained~
`(e) performing analytical chemical tests for uniformity of
`content of said active in substantially equal sized individual
`dosage units sampled from different locations of said resulting
`film, said tests indicating that uniformity of content in the
`amount of said active varies by no more 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; and
`(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 1 0% from the desired amount of the
`active as indicated by said analytical chemical tests.
`
`6
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`
`CLAIM INTERPRETATION AND
`REJECITONS UNDER 35 U.S.C. § 112 (pre-AlA)
`
`A.
`
`PATENT OWNER'S APPEAL OF REJECTIONS OF CLAIM 318
`BASED ON SECTION 112
`
`Claim 318 stands rejected under 35 U.S.C. § 112 (pre-AlA), first and
`
`second paragraphs, as indefinite and lacking written descriptive support.
`
`Patent Owner does not address the Examiner's specific findings and
`
`conclusions articulated in the rejections or explain why these positions are
`
`deficient. PO App. Br. 34-35. Instead, Patent Owner requests entry of an
`
`amendment filed September 3, 2013, which was not entered by the Examiner.
`
`I d. Matters that are petitionable are not before a merits panel for review on
`
`appeal. See 3 7 C.F .R. § 1.181; Manual of Patent Examining Procedure
`
`§ 1002.02(c)(3) (8th ed., Rev. 2, May 2004) and§ 1201 (8th ed., Rev. 3,
`
`August 2005); see also, e.g., In re Berger, 279 F.3d 975, 984-85 (Fed. Cir.
`
`2002) (Issues regarding whether an examiner abused his or her discretion in
`
`matters of practice and procedure are not subject to appeal). Accordingly,
`
`we summarily affirm the Examiner's rejections of claim 318 under 35 U.S.C.
`
`§ 112.
`
`B.
`
`CLAIM INTERPRETATION AND REQUESTER'S APPEAL OF
`NON-ADOPTED REJECTIONS OF CLAIMS BASED ON
`SECTION 112
`
`"suitable for commercialization and regulatory approval ... "
`
`Each of the independent claims recites in the preamble a process of
`
`manufacturing a resulting film or films that are "suitable for
`
`commercialization and regulatory approval, said regulatory approval
`
`7
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
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`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," and the body of each of the claims further recites "said
`
`resulting film is suitable for commercial and regulatory approval, wherein
`
`said regulatory approval is provided by the U.S. Food and Drug
`
`Administration."
`
`Requester proposes the rejection of all the claims on appeal under 35
`
`U.S.C. § 112, first and second paragraphs (pre-AlA), because the above
`
`phrases lack written descriptive support and an enabling disclosure and are
`
`unclear. Req. App. Br. 14-21. In particular, Requester argues that the
`
`phrases require "films meeting all of the requirements for FDA approval."
`
`!d. at 17 and 20. Moreover, Requester contends that the phrases are unclear
`
`because they are subject to at least two interpretations, the Patent Owner's
`
`interpretation, and the interpretation by the Examiner. !d. at 20-21.
`
`Patent Owner contends that the phrases are clear, supported, and
`
`enabled in light of the following portion of the '080 patent:
`
`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 U. S. Federal
`Drug Administration ("FDA"), relating to the variation of
`active in dosage forms. Currently, as 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.
`
`'080 patent, col. 2, ll. 36-46.
`
`8
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
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`The Examiner determined that the language is enabled and definite
`
`and found that the language had written descriptive support in view of the
`
`language in the claim reciting a step of "performing analytical chemical tests
`
`for uniformity of content . . . said tests indicating that uniformity of content
`
`in the amount of the active varies by no more than 10%." RAN 13.
`
`According to the Examiner,
`
`The claims do not require commercialization and regulatory
`approval, they set forth suitability for commercialization and
`regulatory approval. The bright line test for such suitability is
`based on performing analytical chemical tests for uniformity of
`content of active, said tests showing a particular variation of
`active, for example, not more than 10%.
`
`RAN 14. In other words, the Examiner determined that the phrase "suitable
`
`for commercialization and regulatory approval . . . " is limited in scope by
`
`the claim language and the '080 patent to require the film to have a property
`
`of uniformity that varies by not more than 1 0%.
`
`On its face, the phrase "suitable for commercialization and regulatory
`
`approval . . . " suggests much more stringent requirements than merely the
`
`degree of uniformity recited in the claims, as exemplified by Dr. Clevenger's
`
`Declaration. See Clevenger Declaration, executed April 12, 2013, ,-r 4 ("the
`
`route to regulatory approval is an ongoing negotiation with the FDA through
`
`the New Drug Application (NDA) process.
`
`In this negotiation process,
`
`analytical testing and standards are determined for each product depending
`
`on its particular properties and characteristics.
`
`. . . Also, standardized test
`
`methods can change over time (e.g., USP <905> was revised in 2007 and
`
`2011)."). We agree with the Requester that actually obtaining FDA approval
`
`requires more than uniformity of active content.
`
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`Appeal2014-007671
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`However, claim language is not to be read in a vacuum. "Importantly,
`
`the person of ordinary skill in the art is deemed to read the claim term not
`
`only in the context of the particular claim in which the disputed term
`
`appears, but in the context of the entire patent, including the specification."
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). "While the
`
`Board must give the terms their broadest reasonable construction, the
`
`construction cannot be divorced from the specification and the record
`
`evidence." In re NTP, Inc., 654 F3d 1279, 1288 (Fed. Cir. 2011) (citing In
`
`re Suitco Surface, 603 F.3d 1255, 1259 (Fed. Cir. 2010). Moreover, "the
`
`claims themselves provide substantial guidance as to the meaning of
`
`particular claim terms." Phillips, 415 F.3d at 1314. "To begin with, the
`
`context in which a term is used in the asserted claim can be highly
`
`instructive." !d.
`
`The '080 patent describes "various world regulatory authorities"
`
`requiring that "dosage forms may not vary more than 10% in the amount of
`
`active present." Col. 2, 11. 43-45. Thus, our interpretation of "suitability"
`
`must be considered in this context. The '080 Patent discuses a prior art
`
`patent, U.S. Patent No. 4, 136,145 to Fuchs ("Fuchs"), which discloses films
`
`having an active agent that suffer from aggregation or conglomeration of
`
`active materials due to the process by which the films are formed. !d. at col.
`
`2, 11. 7-26. The '080 patent further states that Fuchs' process "is a multi-step
`
`process that adds expense and complexity and is not practical for
`
`commercial use" (id. at col. 2, 11. 57 -59) and that "[ o ]ther factors, such as
`
`mixing techniques, also plays role in the manufacture of a pharmaceutical
`
`10
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`Appeal2014-007671
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`film suitable for commercialization and regulatory approval." !d. at col. 3,
`
`ll. 58-60.
`
`Requester's
`
`interpretation,
`
`I.e.,
`
`reqmnng meeting all of the
`
`requirements for FDA approval, is inconsistent with the limited context with
`
`which FDA approval is described in the '080 patent. We determine that the
`
`phrase does not require that the process claimed actually produce a product
`
`that meets all of the requirements of FDA approval or actually obtain FDA
`
`approval, only a product that has uniformity that would make the product
`
`suitable for obtaining such approval.
`
`In light of the claim language and the
`
`'080 patent, one of ordinary skill in the art would have understood the
`
`phrase to mean producing a film having a uniformity of active content that
`
`may not vary by more than 10% within the film matrix, which we discuss in
`
`further detail below.
`
`The '080 patent also provides written descriptive support for the
`
`claimed phrase. See e.g., '080 patent, col. 15, ll. 37-42 ("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."). Additionally, the '080 patent enables one of ordinary skill in the
`
`art to achieve such suitability using the procedures and methods described
`
`and exemplified therein.
`
`Patent Owner further argues, based on the requirement that the film is
`
`"suitable for commercialization and regulatory approval ... ,"that the
`
`claims of the '080 patent require "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
`
`11
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`A, Bogue Declaration I, EA -1 ), and (ii) in individual dosage units sampled
`
`from two or more lots of resulting films of +I -10% of the pre-determined
`
`desired amount (independent claims 82 and 315, see Appendix B, Bogue
`
`Declaration I, EA-1)." PO App. Br. 18-19 (emphasis added). According to
`
`Patent Owner:
`
`the invention in U.S. Patent No. 7,897,080 (the "'080 Patent")
`is directed to novel and non-obvious processes for
`manufacturing pharmaceutical and bioactive active-containing
`films suitable for commercialization and regulatory approval by
`the U.S. Food and Drug Administration ("FDA"). The
`suitability is with respect to uniformity of content in the amount
`of active in the resulting films, such that:
`(i) the degree of uniformity of content of the amount of
`active (e.g., where the amount of active varies by no more that
`10% between equally sized dosage units) throughout a single
`manufactured roll (lot) of resulting film can also be strictly
`maintained through the claimed processes; and
`(ii) the degree of uniformity of content in the amount of
`active in individual dosage units (e.g., where the amount of
`active in any equally sized dosage unit varies by no more than
`1 0% from the expected or desired amount) taken from different
`manufactured rolls (lots) of resulting films can also be strictly
`maintained through the claimed processes.
`Moreover, commercialization requires the ability to mass
`produce the films at scale and to ensure that resulting film
`products from different manufactured lots (runs) reproducibly
`meet the requisite degree of uniformity in amount of drug.
`PO Reb. Br. 1-2 (emphasis added). Patent Owner suggests that the phrase
`
`"suitable for commercialization and regulatory approval ... " informs one of
`
`ordinary skill in the art that the phrase "substantially uniform distribution of
`
`active" means both "throughout a single manufactured roll (lot) of resulting
`
`film" and "in individual dosage units . . . taken from different manufactured
`
`rolls (lots) of resulting films." !d. In other words, Patent Owner argues that
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`this phrase requires reproducibility among dosage forms within a film matrix
`
`and between film matrices.
`
`In support of this interpretation, the Patent Owner again points to the
`
`background of the '080 patent where the process of Fuchs is discussed as
`
`follows:
`
`dosage forms formed by processes such as Fuchs, would not
`likely meet the stringent standards of governmental or
`regulatory agencies, such as the U.S. Federal Drug
`Administration ("FDA"), relating to the variation of active in
`dosage forms. Currently, as 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.
`'080 patent, col. 2, ll. 38-46.
`
`We disagree that the phrase "suitable for commercialization and
`
`regulatory approval ... " requires reproducibility among dosage forms within
`
`a film matrix and between film matrices in claims 1, 161, 316, 317, or 318.
`
`Claims 1, 161, 316, 317, and 318 are each directed to "A process for
`
`manufacturing a resulting film. " While a process that produces many films
`
`may read on these claims because such a process produces at least one
`
`resulting film, a process that only produces one film also reads on the
`
`claims. Thus, the requirement of suitability "for commercialization and
`
`regulatory approval" must be a property of a single film itself. Claims 1,
`
`161, 316, 317, and 318 do not recite any additional films. Thus, we cannot
`
`agree that reproducibility is a requirement of claims 1, 161, 316, 317, and
`
`318, or the claims that depend therefrom.
`
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`Appeal2014-007671
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`
`This interpretation is supported by the language recited by Patent
`
`Owner that "[ w ]hen applied to dosage units based on films, this virtually
`
`mandates that uniformity in the film be present." '080 patent, col. 2, ll. 45-
`
`46 (emphasis added). Accordingly, this passage is directed to uniformity
`
`within "the film," as is substantially all of the '080 patent, and not between
`
`films. For example, the '080 patent states that
`
`Consideration of the above discussed parameters, such as
`but not limited to rheology properties, viscosity, mixing
`method, casting method and drying method, also impact
`material selection for the different components of the present
`invention. Furthermore, such consideration with proper material
`selection provides the compositions of the present invention,
`including a pharmaceutical and/ or cosmetic dosage form or film
`product having no more than a 10°/o 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.
`Col. 15, ll. 28-42 (emphasis added).
`
`In other words, the invention
`
`particularly addresses a "film product" with uniform active content and
`
`uniform active content "throughout the matrix."
`
`The '080 patent states that the active material is "evenly distributed
`
`throughout the film," which is "achieved by ... the use of a drying process
`
`that reduces aggregation or conglomeration of the components in the film as
`
`it forms into a solid structure." '080 patent, col. 1, ll. 37-47. An objective
`
`of the process is "a substantially non-self-aggregating uniform heterogeneity
`
`throughout the area of the films." !d. at col. 4, ll. 9-11. The '080 patent
`
`14
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`

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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
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`further describes "a substantially reduced occurrence of, i.e. little or no,
`
`aggregation or conglomeration of components within the film as is normally
`
`experienced when films are formed by conventional drying methods." Id.,
`
`col. 6, ll. 27-31. The process of the '080 patent provides "uniform
`
`distribution ofcomponentsfor any given area in the film." !d. at col. 7, ll.
`
`24-26 (emphasis added). Further, the '080 patent describes three tests for
`
`determining uniformity. Each of these tests is described with respect to unit
`
`dosage "from the same film." Id., col. 31, 1. 37 to col. 32, 1. 39; see also col.
`
`29, 11. 33-39. The '080 patent does not expressly describe using these tests
`
`for uniformity with respect to more than one "resulting film."
`
`Claims 82 and 315, however, are directed to "[a] process for
`
`manufacturing resulting films . .. "and include an additional step (f) of
`
`"repeating steps (a) through (e) to form additional resulting films .... "
`
`Accordingly, only with respect to claims 82 and 315 and the claims that
`
`depend therefrom does the phrase "suitable for commercialization and
`
`regulatory approval ... " include both uniformity within an individual film
`
`and reproducibility of the process in the formation of "additional resulting
`
`films."
`
`As pointed out by Patent Owner, the '080 patent recites:
`
`If the testing results show non-uniformity between film
`samples, the manufacturing process may be altered. This can
`save time and expense because the process may be altered prior
`to completing an entire manufacturing run. For example, the
`drying conditions, mixing conditions, compositional
`components and/or film viscosity may be changed. Altering the
`drying conditions may involve changing the temperature,
`drying time, moisture level, and dryer positioning, among
`others.
`
`15
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`
`Moreover, it may be desirable to repeat the steps of
`sampling and testing throughout the manufacturing process.
`Testing at multiple intervals may ensure that uniform film
`dosages are continuously produced. Alterations to the process
`can be implemented at any stage to minimize non-uniformity
`between samples.
`
`'080 patent, col. 29, ll. 39-53. The '080 patent suggests that consistent
`
`manufacturing processes can be expected to produce consistent product.
`
`The principle that identical processes lead to identical results is pervasive in
`
`the case law. See e.g., Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`
`246 F.3d 1368, 1376 (Fed. Cir. 2001) (explaining that newly discovered
`
`results of known processes are not patentable because those results are
`
`inherent in the known processes); In re Best, 562 F.2d 1252, 1255 (CCPA
`
`1977) (holding that where the claimed and prior art products are produced
`
`by identical or substantially identical processes, the PTO can require an
`
`applicant to prove that the prior art products do not necessarily possess the
`
`characteristics of his claimed product). In other words, one of ordinary skill
`
`in the art would expect substantially identical results with a repetition of
`
`substantially identical process steps. Thus, reproducibility of the film
`
`making process has written descriptive support in the '080 patent and is
`
`enabled because the skilled artisan would expect substantially identical
`
`results when merely repeating identical steps and different results using
`
`different steps, as described therein.
`
`For these reasons, we affirm the Examiner's decision not to adopt the
`
`proposed rejection of all the claims under 35 U.S.C. § 112, first and second
`
`paragraphs (pre-AlA).
`
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`Appeal2014-007671
`Reexamination Control 95/002,170
`Patent 7,897,080 B2
`
`"analytical chemical tests"
`
`All the claims on appeal recite a process step that includes
`
`"performing analytical chemical tests for uniformity of content of said active
`
`in substantially equal sized individual dosage units sampled from different
`
`locations of said resulting film."
`
`Requester proposes the rejection of all the claims on appeal under 35
`
`U.S.C. § 112, first and second paragraphs (pre-AlA), because the above
`
`phrase lacks written descriptive support and is unclear. Req. App. Br. 22-23.
`
`According to Requester, the term "analytical chemical tests" is not used in
`
`the '080 patent, and the '080 patent fails to describe any testing methods that
`
`are "chemical" in nature. !d.
`
`In particular, the Requester argues that the
`
`'080 patent describes only a "dissolution" test generally, with no associated
`
`procedure, and a light absorption test for determining the specific amount of
`
`dye content in a film, which is not a "chemical" analysis. !d.
`
`The Examiner determined that the phrase "analytical chemical tests"
`
`means "analytical tests for determining the amount of active content in the
`
`recited sample." RAN 8 and 16. The Examiner reached this interpretation
`
`because the '080 patent describes "testing films of the present invention for
`
`chemical and physical uniformity." RAN 8 (citing '080 patent, col. 28, 1. 66
`
`to col. 29, 1. 1 ). The
`
`'080 patent then describes testing by visual
`
`examination for agglomerations, weighing identically sized individual
`
`dosages cut from the film, and "dissolving individual doses and testing for
`
`the amount of active therein." RAN 8-9 (citing col. 29, ll. 3-47 and col. 31,
`
`1. 37 to col. 32, 1. 39). According to the Examiner, "physical" uniformity
`
`refers to uniformity in appearance and physical properties, such as weight,
`
`17
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`
`Appeal201