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
`
`95/002,171
`
`09/10/2012
`
`7666337
`
`117744—00030
`
`1084
`
`Hoffmann & B aron LLP
`
`6900 Jericho Turnpike
`Syosset, NY 11791
`
`DIAMOND» ALAN D
`
`ART UNIT
`
`3991
`
`MAIL DATE
`
`03/27/2015
`
`PAPER NUMBER
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`DELIVERY MODE
`
`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.
`
`PT0L'90A <ReV~ 04/07)
`
`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA INC. v. IVIONOSOL RX LLC
`
`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`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
`
`Appeal 20l4—0O8893
`Reexamination Control 95/002, l7l
`
`Patent 7,666,337 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 7,666,337 B2 (hereinafter the “’337 patent”).1
`
`1 The ’337 patent issued February 23, 2010, to Robert K. Yang, et al.
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

`
`Appeal 2014—0O8893
`Reexamination Control 95/002, 1 7 1
`
`Patent 7,666,337 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.F.R. §§ 1.902—1.997 for the ’O8O 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 April 18, 2014 (hereinafter “Req. App. Br.”); Requester’s Respondent
`
`Brief, dated May 22, 2014 (hereinafter “Req. Res. Br.”); Requester’s
`
`Rebuttal Brief, dated July 1, 2014 (hereinafter “Req. Reb. Br.”). The Patent
`
`Owner and Appellant is MonoSol Rx, LLC (hereinafter “Patent Owner”).
`
`Patent Owner’s Appeal Brief 1, dated March 31, 2014 (hereinafter “PO App.
`
`Br.”); Patent Owner’s Respondent Brief, dated May 19, 2014 (hereinafter
`
`“PO Res. Br.”); Patent Owner’s Rebuttal Brief, dated July 7, 2014 (herein
`
`after “PO Reb. Br.”).
`
`The ’337 patent is the subject of a litigation proceeding in the United
`
`States District Court for the Eastern District of North Carolina styled
`
`Bi0Delivery Sciences International, Inc. V. Reckitt Benckiser
`
`Pharmaceuticals, Inc. et al., 5—14—cV—0O529 (NCED). The litigation was
`
`filed on September 20, 2014 and is currently pending.
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Appeal 20l4-008893
`Reexamination Control 95/002, l 7 1
`
`Patent 7,666,337 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 ’337 patent is directed to a method for forming a rapidly
`
`dissolving film containing an active ingredient evenly or uniformly
`
`distributed throughout the film.
`
`’337 patent, col. 1, 11. 35-40. According to
`
`the ’337 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 fonns into
`
`a solid structure.” Id., col. 1, 11. 40-45.
`
`The ’337 patent originally contained claims 1-30, of which claims 1-
`
`24 were not subject to reexamination. During reexamination, Patent Owner
`
`cancelled claim 28 and added claims 31-404. Patent Owner cancelled
`
`claims 55-61, 76, and 78-404 in the Appeal Brief (see PO App. Br. 3 and 4)
`
`and in a separate Amendment filed April 22, 2014. The April 22, 2014
`
`amendment was entered by the Examiner in a communication mailed April
`
`24, 2014 and was noted in the Examiner’s Answer. Thus, claims 25-27, 29-
`
`54, 62-75, and 77 currently are pending and are rejected by the Examiner.
`
`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.F.R. § 4l.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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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Appeal 20l4—008893
`Reexamination Control 95/002, l 7 1
`
`Patent 7,666,337 B2
`
`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 of
`
`enablement and/or lack of written descriptive support for several recitations
`
`within the claims.
`
`Claim 25 is the sole independent claims at issue in this appeal, is
`
`representative, and reads as follows (with underlining showing added
`
`language and brackets showing deleted language over the original patented
`
`claim):
`
`A process for [making a ]manufacturing a resulting
`25.
`pharmaceutical film suitable for commercialization and
`regulatory approval said film having a substantially unifonn
`distribution of components comprising a pharmaceutical active,
`comprising the steps of:
`(a) forming a flowable polymer matrix comprising a
`water—soluble polymer, a solvent and a[n] phannaceutical active
`selected from the group consisting of | a list of pharmaceutical
`drug categories3| and combinations thereof, said matrix having
`a unifonn distribution of said pharmaceutical active;
`(b) casting said flowable polymer matrix, said polymer
`matrix having a viscosity from about 400 to about 100,000 cps;
`(c) conveying said polymer matrix through a drying
`apparatus and evaporating at least a portion of said solvent
`[from said flowable polymer matrix] to rapidly fonn a visco-
`elastic film having said pharmaceutical active unifonnly
`distributed throughout by rapidly increasing the viscosity of
`said polymer matrix upon initiation of drying within about th_e
`first [l0]fl minutes [or fewer ]to maintain said uniform
`
`3 In the interest of brevity, we do not repeat the entire list of over 100 recited
`pharmaceutical active categories, which are not particularly relevant to the
`issues on appeal. See PO App. Br. CA—l to CA—2, Claim App’x; Req. App.
`Br. CA—l to CA—2, Claim App’x.
`
`4
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Appeal 2014-008893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
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`distribution of said pharmaceutical active by locking-in or
`substantially preventing migration of said pharmaceutical active
`within said visco—elastic film wherein the polymer matrix
`temperature is 1000C or less; [and]
`(d) forming [a]th_e resulting pharmaceutical film from
`said visco—elastic film, wherein said resulting pharmaceutical
`film has a water content of 10% or less and said uniform
`
`distribution of pharmaceutical active by said locking-in or
`substantially preventing migration of said pharmaceutical active
`is maintained,
`
`gej taking samples of the resulting pharmaceutical film at
`different locations of the resulting pharmaceutical film; and
`1f) performing analytical chemical tests for content
`uniformity of said pharmaceutical active in substantially egual
`sized individual dosage units of said sampled resulting
`pharmaceutical film, said tests indicating said substantially
`uniform distribution of the pharmaceutical active, in that the
`amount of the pharmaceutical active varies by no more than
`1 0%.
`
`CLAIM INTERPRETATION AND
`
`REJECTIONS UNDER 35 U.S.C. § 314(a) (pre-AIA)
`
`The Examiner maintained the rejection of claims 55-61, 76, and 78-
`
`404 under 35 U.S.C. § 314(a) as enlarging the scope of the claims of the
`
`patent being reexamined. RAN 12-13.
`
`We agree with the Patent Owner that the cancellation of claims 55-61,
`
`76, and 78-404 render the rejection of such claims moot. PO App. Br. 34.
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Appeal 2014-008893
`Reexamination Control 95/002, 1 7 1
`
`Patent 7,666,337 B2
`
`CLAIM INTERPRETATION AND
`
`REJECTIONS UNDER 35 U.S.C. § 112 (pre—AIA)
`
`A.
`
`CLAIM INTERPRETATION AND PATENT OWNER’S APPEAL
`
`OF REJECTIONS OF CLAIMS BASED ON SECTION 112
`
`All of the claims on appeal stands rejected under 35 U.S.C. § 112, second
`
`paragraph (pre—AIA), as being indefinite.
`
`Mulfiplicizy
`
`The Examiner rejected claims 31-404 for undue multiplicity. The
`
`Examiner indicated that “such a large number of claims, i.e., 374 new
`
`claims, is unreasonable .
`
`.
`
`. the net result of which is to confuse rather than
`
`clarify.” RAN 25.
`
`Patent Owner contends that, with cancellation of claims 55-61, 76,
`
`and 78-404, “[t]he remaining 39 claims, claims 31-54, 62-75 and 77, have
`
`no multiplicity, at all, and therefore the rejections (RAN 25) as to these
`
`claims should be withdrawn.” PO App. Br. 35.
`
`Requester disagrees indicating that cancellation of claims does not
`
`create an error in a rejection that was otherwise appropriate. Req. Res. Br.
`
`36. Requester further notes that at least claim 32 still includes repetition in
`
`that a requirement for FDA approval is the only regulatory agency to
`
`provide approval for a process for making a pharmaceutical film. Id.
`
`Cancellation of claims can render a particular rejection maintained by
`
`the Examiner moot. Moreover, we disagree with Requester that claim 32 is
`
`duplicative of claim 25. The language of claim 32 is not identical to that of
`
`claim 25, and we determine that the claim language, properly interpreted, as
`
`6
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Appeal 2014-008893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
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`discussed in detail below, does not render the language of claim 32
`
`indefinite.
`
`With the cancellation of claims 55-61, 76, and 78-404, the rejection of
`
`claims 31-404 under 35 U.S.C. § 112 for undue multiplicity is rendered
`
`moot.
`
`“wherein the polymer matrix temperature is 1000C or less”
`
`Claim 25, as amended, recites a step of “conveying said polymer
`
`matrix through a drying apparatus and evaporating at least a portion of said
`
`solvent to rapidly form a visco-elastic film .
`
`.
`
`. wherein the polymer matrix
`
`temperature is 1000C or less;
`
`According to the Examiner, “[i]t is not clear if the term ‘the polymer
`
`matrix’ is referring to the flowable polymer matrix in steps (a) and (b), or a
`
`polymer matrix that is present in the formed visco-elastic film.” RAN 25.
`
`Patent Owner responds that “[i]t is quite clear from the claims that
`
`‘the polymer matrix’ in step (c) refers to ‘said flowable polymer matrix’ in
`
`step (b) and to ‘a flowable polymer matrix’ in step (a).” PO App. Br. 36.
`
`Requester notes Patent Owner “does not, and cannot, explain why the
`
`temperature limitation at the end of a drying step does not reference and
`
`apply to the article in the drying step.” Req. Res. Br. 34-35.
`
`We agree with the Patent Owner that the reference the “the polymer
`
`matrix” reasonably refers to the “flowable polymer matrix.” See PO App.
`
`Br. 36. Moreover, one of ordinary skill
`
`in the art would not find the
`
`temperature recitation unclear. The temperature is recited as a part of the
`
`“conveying” and “evaporating” step. Thus, the temperature is directed to the
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Appeal 2014—008893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
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`time frame during which the flowable polymer matrix of steps (a) and (b) is
`
`being “conveyed” and some solvent is being “evaporated,” i.e., while the
`
`flowable polymer matrix is being dried. The phrase merely identifies a
`
`parameter for the “conveying” and “evaporating” step. This interpretation is
`
`consistent with the ’337 patent which sets 100 0C as a preferred maximum
`
`temperature because “[t]emperatures that approach 100 0C. will generally
`
`cause degradation of proteins as well as nucleic acids.” ’337 patent, col. 12,
`
`11. 20-25; col. 27, 11. 53-55. Thus, allowing the polymer matrix temperature
`
`to reach over 100 0C during the drying process might lead to degradation of
`
`some active material.
`
`To the extent that Requester cannot identify solvents and/or oven
`
`temperatures that are excluded by the language (see Requester’s Comments
`
`of February 28, 2013), we decline to determine the language indefinite on
`
`this basis. “[B]readth is not indefiniteness.” In re Gardner, 427 F.2d 786,
`
`788 (CCPA 1970).
`
`Accordingly, we reverse the Examiner’s rejection of all the claims
`
`under 35 U.S.C. § 112, second paragraph (pre—AIA).
`
`“a process for manufacturing a resulting pharmaceuticalfilm suitable for
`commercialization and regulatory approval”
`
`Claim 25 recites in the preamble a process of manufacturing a
`
`resulting film that is “suitable for commercialization and regulatory approval
`
`said film having a substantially unifonn distribution of components
`
`comprising a pharmaceutical active.” Claim 32 further recites “wherein
`
`regulatory approval is provided by the U.S. Food and Drug Administration.”
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Appeal 2014—008893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
`
`The Examiner rejected the claim under 35 U.S.C. § 112, second
`
`paragraph (pre—AIA), because the language is not clear in the body of the
`
`claim what makes the resulting film suitable for commercialization and
`
`regulatory approval. RAN 26. Requester further contends that the phrases
`
`are unclear because they are subject to multiple interpretations argued at
`
`different times by Patent Owner. Req. Res. Br. 35.
`
`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 tenns 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 tenns.”
`
`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.” Id.
`
`Patent Owner contends that the phrase is clear in light of the
`
`additional language of the preamble reciting “having a substantially uniform
`
`distribution of components” and the following portion of the ’337 patent (PO
`
`App. Br. 36-37):
`
`Failure to achieve a high degree of accuracy with respect to the
`amount of active ingredient in the cut film can be hannful to the
`patient. For this reason, dosage fonns formed by processes such
`as Fuchs, would not likely meet the stringent standards of
`governmental or regulatory agencies, such as the U. S. Federal
`
`9
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
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`Appeal 2014-008893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
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`Drug Administration (“FDA”), relating to the variation of
`active in dosage forms. Currently, as required by various world
`regulatory authorities, dosage fonns 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.
`
`’337 patent, col. 2, 11. 34-44.
`
`The ’337 patent describes “various world regulatory authorities”
`
`requiring that “dosage fonns may not vary more than 10% in the amount of
`
`active present.” Id. The ’08O 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.
`
`Id. at col. 2, 11. 5-24. The
`
`’337 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
`
`11. 55-57) and that “[o]ther factors, such as mixing techniques, also plays role
`
`in the manufacture of a pharmaceutical film suitable for commercialization
`
`and regulatory approval.” Id. at col. 3, 11. 56-58. Thus, our interpretation of
`
`“suitability” must be considered in this context.
`
`The additional language of the preamble directs the meaning of the phrase to
`
`the unifonnity context and the body of the claim further defines what is
`
`meant by uniformity. 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 ’337 patent, one of ordinary skill in
`
`the art would have understood the phrase to mean producing a film having a
`
`10
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`Appeal 2014-008893
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`Patent 7,666,337 B2
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`uniformity of active content that may not vary by more than 10% within the
`
`film matrix, which we discuss in further detail below.
`
`The ’337 patent
`
`also provides written descriptive support for the
`
`claimed phrase. See e.g., ’337 patent, col. 15, 11. 37-40 (“the unifonnity 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 ’337 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 ’337 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 claim 25, see Appendix A, Bogue
`
`Declaration 11, EA -2), M (ii) in individual dosage units sampled from two
`
`or more lots of resulting films within 10% of the pre-detennined desired
`
`amount (dependent claim 32, see Appendix B, Bogue Declaration 11, EA-
`
`2).” PO App. Br. 17-18 (emphasis added). According to Patent Owner:
`
`the ’337 Patent is directed to novel and non-obvious processes
`for manufacturing pharmaceutical and bioactive active-
`containing films suitable for commercialization and regulatory
`approval, ultimately by the U.S. Food and Drug Administration
`(“FDA”). Suitability is with respect to uniformity of content in
`the amount of active in the resulting films, such that:
`(i) the degree of unifonnity 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 (all claims); M
`
`11
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`TEVA EXHIBIT 1037
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`Appeal 20l4—0O8893
`Reexamination Control 95/002, l 7 1
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`Patent 7,666,337 B2
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`(ii) the degree of unifonnity 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
`10% from the expected or desired amount) taken from different
`manufactured rolls (lots) of resulting films can also be strictly
`maintained through the claimed process of claim 32, thus
`meeting the uniformity requirements across different
`manufacturing rolls of resulting films.
`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. 4-5 (emphasis added). In other words, Patent Owner suggests
`
`that the phrase “wherein regulatory approval is provided by the U.S. Food
`
`and Drug Administration” 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.”
`
`Id. In other words, Patent Owner argues that this phrase requires
`
`reproducibility among dosage fonns within a film matrix and between film
`
`matrices.
`
`In support of this interpretation, the Patent Owner again points to the
`
`background of the ’337 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 fonns may not vary more than
`10% in the amount of active present. When applied to dosage
`
`l2
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Appeal 20l4—0O8893
`Reexamination Control 95/002, l 7 1
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`Patent 7,666,337 B2
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`units based on films, this virtually mandates that uniformity in
`the film be present.
`
`’337 patent, col. 2, 11. 36-44.
`
`We disagree that the phrase “wherein regulatory approval is provided
`
`by the U.S. Food and Drug Administration” requires reproducibility among
`
`dosage forms within a film matrix and between film matrices in claim 32.
`
`Claim 25, from which claim 32 depends, is directed to “A process for
`
`manufacturing a resultingfilm. ” 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. Neither claim
`
`25 nor claim 32 recites any additional films. Thus, we cannot agree that
`
`reproducibility is a requirement of the claims, as argued by Patent Owner.
`
`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 unifonnity in the film be present.” ’337 patent, col. 2, ll. 43-
`
`44 (emphasis added). Accordingly, this passage is directed to uniformity
`
`within “the film” as is substantially all of the ’337 patent and not between
`
`films. For example, the ’337 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. Furthennore, 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% variance of a
`pharmaceutical and/or cosmetic active per unit area. In
`
`13
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Appeal 2014-008893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
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`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,
`
`11. 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 ’337 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 fonns into a solid structure.” ’337 patent, col. 1, 11. 38-45. An objective
`
`of the process is “a substantially non—self—aggregating uniform heterogeneity
`
`throughout the area of the films.” Id. at col. 4, 11. 7-9. The ’337 patent
`
`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, 11. 25-29. The process of the ’337 patent provides “uniform
`
`distribution of components for any given area in the film.” Id. at col. 7, 11.
`
`23-25 (emphasis added). Further, the ’337 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. 38 to col. 32, 1. 40; see also col.
`
`29, 11. 33-39. The ’337 patent does not expressly describe using these tests
`
`for uniformity with respect to more than one “resulting film.”
`
`The ’337 patent also recites:
`
`If the testing results show non-uniformity between film
`samples, the manufacturing process may be altered. This can
`
`14
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

`
`Appeal 20l4—0O8893
`Reexamination Control 95/002, l 7 1
`
`Patent 7,666,337 B2
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`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.
`
`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—unifonnity
`between samples.
`
`’337 patent, col. 29, 11. 39-53. Thus, the ’337 patent suggests that consistent
`
`manufacturing processes can be expected to produce consistent product.
`
`While one of ordinary skill in the art would expect substantially identical
`
`results with a repetition of substantially identical process steps, the language
`
`of claim 32, “wherein regulatory approval is provided by the U.S. Food and
`
`Drug Administration,” is not adequately identified in the specification to
`
`specifically refer to reproducibility between film matrices.
`
`For these reasons, we reverse the Examiner’s rejection of all the
`
`claims under 35 U.S.C. § 112, second paragraph (pre—AIA).
`
`CLAIM INTERPRETATION AND REQUESTER’S APPEAL OF
`B.
`NON-ADOPTED REJECTIONS OF CLAIMS BASED ON SECTION ll2
`
`“analytical chemical tests ”
`
`Claim 25,
`
`as
`
`amended,
`
`recites
`
`a process
`
`step that
`
`includes
`
`“perfonning analytical chemical
`
`tests
`
`for content uniformity of said
`
`15
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Appeal 2014—0O8893
`Reexamination Control 95/002, 1 7 1
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`Patent 7,666,337 B2
`
`pharmaceutical active in substantially equal sized individual dosage units of
`
`said sampled resulting pharmaceutical film.”
`
`Requester proposes the rejection of all the claims on appeal under 35
`
`U.S.C. § 112, first and second paragraphs (pre—AIA), because the above
`
`phrase lacks written descriptive support and is unclear. Req. App. Br. 17.
`
`According to Requester, the term “analytical chemical tests” is not used in
`
`the ’337 patent, and the ’337 patent does not describe or employ analytical
`
`chemical test to verify the amount of pharmaceutical active in any dosage
`
`unit.
`
`Id. at 18.
`
`In particular, the Requester argues that the light absorption
`
`test for determining the specific amount of dye content in a film (Example M
`
`of the ’337 patent) is not a “chemical based” test. Id.
`
`The Examiner detennined that the phrase “analytical chemical tests”
`
`means “analytical tests for detennining the amount of active content in the
`
`recited sample.”
`
`RAN 9-10 and 22.
`
`The Examiner
`
`reached this
`
`interpretation because the ’337 patent describes “testing films of the present
`
`invention for chemical and physical uniformity.” RAN 9 (citing ’337 patent,
`
`col. 28, 1. 66 to col. 29, 1. 1). The ’337 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.” Id. (citing col. 29, 11. 3-47 and col. 31, 1. 38 to
`
`col. 32, l. 40). According to the Examiner, “physical” uniformity refers to
`
`unifonnity in appearance and physical properties, such as weight, while
`
`“chemical” unifonnity refers to the actual amount of active material
`
`dispersed within the film matrix.
`
`Id.
`
`Patent Owner agrees with the
`
`Examiner’s interpretation. PO Res. Br. 19.
`
`16
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`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1037
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

`
`Appeal 20l4—0O8893
`Reexamination Control 95/002, l 7 1
`
`Patent 7,666,337 B2
`
`The additional claim language reveals that the results of “perfonning
`
`chemical analytical tests for content unifonnity” is an indication of “said
`
`substantially uniform distribution of the pharmaceutical active, in that the
`
`amount of the pharmaceutical active varies by no more than 10%.”
`
`It is
`
`only through a test that detennines the actual amount of active content
`
`within the film matrix that it can be determined whether or not the “amount
`
`of the pharmaceutical active” varies by no more than 10%. The ’337 patent
`
`does not suggest that “amount of pharmaceutical active” can be determined
`
`by visual
`
`inspection or by weight measurements alone, although these
`
`methods nonetheless may be used to determine whether or not the active
`9
`amount within a film matrix is “substantially uniform.’ Accordingly, we
`
`find the Examiner’s interpretation reasonable in light of the claim language
`
`and ’337 patent disclosure.
`
`Further, it is particularly relevant that the ’337 patent states that “[a]ny
`
`conventional means for examining and testing the film pieces may be
`
`employed,
`
`such as,
`
`for example, visual
`
`inspection, use of analytical
`
`equipment, and other suitable means known to those skilled in the art.” ’337
`
`patent, col. 29, 11. 35-39. In other words, the tenn “analytical chemical tests”
`
`are not limited to a dissolution test or a light absorption test, as described in
`
`the ’337 patent. Rather, any test known in the art for determining the actual
`
`amount of active content within samples of a film matrix would fall within
`
`the scope of the phrase “analytical chemical tests.”
`
`We determine that the phrase, “analytical chemical tests,” in light of
`
`the claim language and the ’337 patent, would have been clear to one of
`
`ordinary skill in the art, and would mean analytical tests for detenninin