U NITED STATES P ATENT AND TRADEMARK O FFICE
`
`UNITED STATES DEPA RTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. ll<>x 1450
`Alexandria. Virginia 22313-1450
`www.uspto.go''
`
`APPLICATION NO.
`
`FIUNGDATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`95/001.753
`
`09/12/2011
`
`7.824.588
`
`117744-00016
`
`6620
`
`23869
`7590
`Hoffmann & Baron LLP
`6900 Jericho Turnpike
`Syosset, NY 11791
`
`04117/2014
`
`EXAMINER
`
`DIAMOND, ALAN D
`
`ART UNIT
`
`PAPER NUMBER
`
`3991
`
`MAil. DATE
`
`04/17/2014
`
`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.
`
`PTOL-90A (Rev. 04/07)
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`DRL - EXHIBIT 1038
`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
`
`v.
`
`MONOSOL RX, LLC
`Patent Owner and Appellant
`
`Appeal 2014-000547
`Reexa1nination Control 951001, 7 53
`Patent 7 ,824,588 B2
`Technology Center 3900
`
`Before CHUNG K. PAK, JEFFREY B. ROBERTSON, and
`RAEL YNN 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 ,824,588 B2 (herein after the "'588 patent"). 1
`
`1 The ' 588 patent issued November 2, 2010, to Robert K. Yang, et al.
`
`DRL - EXHIBIT 1038
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`

`
`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 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 interpartes reexamination under 35 U.S.C. §§ 311-318
`
`and 37 C.F.R. §§ 1.902-1.997 for the '588 patent was filed on
`
`September 12, 2011 , by a Third-Party Requester, BioDelivery Sciences
`
`International, Inc. (hereinafter "Requester"). See Request for Inter Partes
`
`Reexamination 1 (hereinafter "Request"); Requester's Respondent Brief,
`
`dated July 24, 2013 (hereinafter "Res. Br."). The Patent Owner and
`
`Appellant is MonoSol Rx, LLC (hereinafter "Patent Owner"). Patent
`
`Owner's Appeal Br. 1, dated June 24, 2013 (hereinafter "App. Br.").
`
`The '588 patent is the subject of a litigation proceeding in the United
`
`States District Court for the District of New Jersey styled MonoSol Rx, LLC
`
`v. BioDelivery Sciences Int'l, Inc. , 10-cv-5695. The litigation is currently
`
`stayed pending the outcome of this Reexamination proceeding. See App.
`
`Br. 2.
`
`An oral hearing was held March 26, 2014. A transcript of the hearing
`
`will be entered into the record in due course.
`
`The '588 patent is directed to a method for fom1ing a rapidly
`
`dissolving film containing an active ingredient evenly or uniformly
`
`distributed throughout the film. '588 patent, col. 1, 11. 35-42. According to
`
`the '588 patent, "uniform distribution is achieved by controlling one or more
`
`parameters, and particularly the elimination of air pockets prior to and
`
`during film fonnation and the use of a drying process that reduces
`
`2
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`
`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`aggregation or conglomeration of the components in the film as it fonns into
`
`a solid structure." Id. at col. 1, 11. 37-42.
`
`The '588 patent originally contained claims 1-191. During
`
`reexamination, Patent Owner amended claim 1 and added new independent
`
`claims 192 and 193. Claims 1-193 are currently rejected by the Examiner.
`
`Although Patent Owner appeals the rejection of all of the claims so
`
`rejected, with respect to independent claims 25 and 50 and the claims that
`
`depend therefrom, 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. 4. Accordingly, we summarily affirm the
`
`Examiner's rejections of claims 25 and 50 and the claims that depend
`
`therefrom.
`
`Consistent with the arguments presented by Patent Owner, we address
`
`the rejections of claims 1-24, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 106,
`
`111-132, 177, 178, 183, 186, 189, 192,and 193. Id.
`
`Claims 1, 192 and 193 are at issue in this appeal and read as follows
`
`(with underlining showing additional language over the original patented
`
`claim):
`
`1. A method of making a self-supporting therapeutic
`active-containing film comprising:
`(a) Mixing at least one edible polymer component, a
`therapeutic active composition, and at least one polar solvent to
`fom1 a matrix;
`(b) Forming a wet film from said matrix, said wet film
`having a substantially uniform content of therapeutic active
`composition throughout said wet film;
`( c) Removing said polar solvent from said matrix with
`heat and/or radiation energy by exposing said matrix to a
`
`3
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`temperature greater than the degradation temperature of said
`therapeutic active composition to form a self-supporting film;
`wherein the temperature of the matrix is l 00° C. or less
`during said step of removing said polar solvent from said
`matrix~
`wherein the resulting self-supporting film maintains the
`substantially uniform content of therapeutic active composition
`per unit of film.
`
`192. A method of making a self-supporting therapeutic
`active-containing film comprising:
`Ca) Mixing at least one edible polymer component, a
`therapeutic active composition and at least one polar solvent to
`fom1 a matrix;
`Cb) Forming a wet film from said matrix, said wet film
`having a substantially unifom1 content of therapeutic active
`composition throughout said wet film;
`Cc) Removing said polar solvent from said matrix with
`heat and/or radiation energy by heating said matrix to a
`temperature that is less than the boiling point of said at least
`one polar solvent so as to fon11 a viscoelastic film;
`wherein the resulting viscoelastic film maintains the
`substantially uniform content of therapeutic active composition
`per unit of fihn.
`
`193. A method of making a self-supporting therapeutic
`active-containing film comprising:
`Ca) Mixing at least one edible polymer component, a
`therapeutic active composition. and at least one polar solvent to
`form a matrix;
`(b) Forming a wet film from said matrix. said wet film
`having a substantially uniform content of therapeutic active
`composition throughout said wet film;
`(c) Using heat and/or radiation energy to remove said
`polar solvent from said matrix to form a self-supporting
`therapeutic active-containing film without fom1ing bubbles;
`
`4
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`wherein the resulting self-supporting film maintains the
`substantially uniform content of therapeutic active c0111position
`per unit of film.
`
`REJECTIONS OF CLAIMS BASED ON SECTION 112
`
`Claims 1-24, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 106, 111-
`
`132, 177, 178, 183, 186, 189, 192 and 193 stand rejected under 35 U.S.C.
`
`§ 112, first and second paragraphs as indefinite, lacking in written
`
`description support, and lacking an enabling disclosure.
`
`Claim 1 was amended during reexamination to recite a self-supporting
`
`therapeutic active-containing film in which there is "a substantially unifonn
`
`content of therapeutic active composition" in both the wet film and
`
`maintained in the resulting self-supporting film "per unit of film."
`
`Claims 192 and 193 are new claims and have similar language to that added
`
`to claim l .
`
`The Examiner found that "[i]t is not clear exactly what is
`
`encompassed by a substantially uniform content of therapeutic active
`
`composition, and the '588 patent does not provide a definition for a
`
`substantially uniform content of therapeutic active composition." RAN at 9.
`
`The Examiner thus rejects the clailn as being indefinite under 35 U.S.C.
`
`§ 112, second paragraph, and as lacking adequate written descriptive support
`
`and lacking an enabling disclosure in the '588 patent under 35 U.S.C. § 112,
`
`first paragraph. Id. at 9-10. The Examiner further explains that "it is not
`
`clear how close to being uniform the product must be in order to be
`
`considered 'substantially unifonn'. 'Substantially uniform' is not defined in
`
`the '588 patent." Id. at 68-69.
`
`5
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`Patent Owner argues that the phrase "substantially unifonn content of
`
`therapeutic active composition" means "a film having a degree of unifom1ity
`
`of± 10% from the FD A label amount for the active per dosage unit." App.
`Br. 20.2 In other words, the Patent Owner is arguing that the substantially
`
`uniform content must be defined with respect to a particular active content
`
`recognized and labeled by the FDA as a proper "dosage."
`
`In support of this meaning, the Patent Owner points to the background
`
`of the '588 patent where the process of Fuchs is discussed as follows:
`
`dosage fonns fanned 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 fonns. 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.
`'588 patent, col. 2, 11. 25-44.
`
`We disagree with the Patent Owner's interpretation of the phrase
`
`"substantially uniform content of therapeutic active composition." The
`
`2 LY App. Br. 24 (defining the phrase as "a degree ofunifom1ity sufficient to
`maintain the amount of active in each dosage unit within 10% of the
`FDA amount of active."); App. Br. 15 (defining only the tem1 uniformity as
`"the amount of active present may not vary more than 10% from amount of
`the active set by the FDA, for example, in a unit dose (per unit of film, i.e. in
`a film unit)"); Patent Owner's Rebuttal Brief 3, dated September 9, 2013
`(hereinafter "Reb. Br.") (defining the phrase as "a degree ofunifon11ity
`consistent with FDA phan11aceutical products and must include the limited
`variation such that the amount of active present may not vary more than
`10% from the amount of the active set by the FDA per unit of film , i.e. per
`therapeutic dosage unit.").
`
`6
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`
`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`FDA standard identified by Patent Owner in the portion of the '588 patent
`
`reproduced supra, is not again referenced. In the remaining parts of the
`
`' 588 patent, uniformity is characterized not with respect to an FDA
`
`recognized dosage, but with respect to the lack of agglomeration of active
`
`material in any part of the film. For example, the '588 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." '588 patent, col. 1, 11. 37-42. An objective of the process is "a
`
`substantially non-self-aggregating uniform heterogeneity throughout the area
`
`of the films. " Id. at col. 4, 11. 5-9. The ' 588 patent further describes "a
`
`substantially reduced occurrence of, i.e. little or no, aggregation or
`
`conglomeration of components within the film as is non11ally experienced
`
`when films are formed by conventional drying methods." Id. , col. 6, 11. 25-
`
`32. The process of the ' 588 patent provides "uniform distribution of
`
`components/or any given area in the film." Id. at col. 7, 11. 26-29 (emphasis
`
`added).
`
`Requiring a particular film to have an amount of active relative to a
`
`FDA recognized dosage considers the active amount in each individual
`
`"dosage unit" as compared to a particularly preferred or desired dosage.
`
`Patent Owner's interpretation disregards whether or not the active is
`
`agglomerated within the film and considers only a total amount of active
`
`material per dosage sized film rather than unifon11ity at any given area in the
`
`film, be it a small selected area, an area of the film consistent with a
`
`particular dosage, or an entire roll of film. Accordingly, the sentence relied
`
`7
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`
`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`upon by the Patent Owner, stating that uniformity is "virtually mandated" by
`
`FD A requirements that the actual dosage be within a range of the labeled
`
`dosage, does not provide a definition of what would be considered
`
`''uniform," in light of the description of the '588 patent.
`
`Further, the '588 patent describes three tests for determining
`
`uniformity. The first test was a visual inspection by "either the naked eye or
`
`under slight magnification. By viewing the films it was apparent that they
`
`were substantially free of aggregation, i.e. the carrier and the actives
`
`remained substantially in place and did not move substantially from one
`
`portion of the film to another." Id. at col. 28, 11. 1-9. This first test is not
`
`consistent with the Patent Owner's interpretation because the test does not
`
`measure the active content with respect to any particular desired dosage.
`
`Further, Patent Owner's interpretation does not exclude the presence of
`
`agglomerated particles, which is the purpose of the visual appearance test.
`
`The second test involved cutting out "dosage forms" "from random
`
`locations throughout the film" and additively weighing the randomly
`
`selected dosage fon11s. Id. at col. 28, 11. 10-16. Table 2 shows that with
`
`each additional dosage fonn, the weight increased by exactly 0.04g. Id. at
`
`col. 28, 11. 19-65. The '588 patent explains that "each component has a
`
`unique density. Therefore, when the components of different densities are
`
`combined in a uniform manner in a film, as in the present invention,
`
`individual dosages forms from the same film of substantially equal
`
`dimensions, will contain the same mass." Id. at col. 29, 11. 3-9. This second
`
`test also is not consistent with the Patent Owner's interpretation because the
`
`test does not measure the active content with respect to any particular
`
`8
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`desired dosage. Rather, the second test is directed towards comparing the
`
`active content at various locations on the same film.
`
`The third test involved dissolving "individual doses" and testing for
`
`the amount of active in films of particular size. Id. at col. 29, 11. l 0-12. The
`
`'588 patent states that "[t]his demonstrates that films of substantially similar
`
`size cut from different locations on the same film contain substantially the
`
`same amount of active." Id. at col. 29, 11. 13-15. Although the third test
`
`determines the actual amount of active within a dosage sized film, the third
`
`test also is not consistent with Patent Owner's interpretation because the test
`
`does not measure the active content with respect to any particular desired
`
`dosage. Rather, the third test is directed towards comparing the active
`
`content at various locations on the same film.
`
`Accordingly, we conclude that the term "uniform" in the claims is not
`
`directed to uniformity as compared to a particular FDA dosage as proposed
`
`by Patent Owner, but rather non-agglomerated and evenly dispersed active
`
`content for any area of a given film.
`
`This claim interpretation is more consistent with the Examiner's
`
`interpretation of the phrase "unit of film," with which the Patent Owner
`
`agrees. App. Br. 17. The Examiner determined that the phrase "unit of
`
`film" was broad, but definite, and indicated that " [i]t could be a roll of
`
`finished film, it could be a standard area of dried film before being cut, or it
`
`could be a dosage unit. Any size can be a unit." RAN 11.
`
`Further, we agree with the Examiner that, while the term "unifonn"
`
`appears definite in light of the '588 patent, we are not instructed as to the
`
`scope to which a film may be "substantially uniform." We are not provided
`
`9
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`a degree of agglomeration or an amount of unevenly dispersed active
`
`material for which the filn1 would still be acceptable. Considering that the
`
`second, additive-weight-based test shows only complete uniformity, with no
`
`additional films weighing more or less than exactly 0.04g, we are not
`
`instructed as to what deviation in weight would be considered "substantially
`
`uniform." Further, we are not provided the results of the dissolution test as
`
`evidence of a range of acceptable unifon11ity.
`
`Words of degree may lack precision, but they do not necessarily
`
`render a claim indefinite. Seattle Box Co. , Inc. v. Indus. Crating & Packing,
`
`Inc. , 731F.2d818, 826 (Fed. Cir. 1984) (A tem1 of degree is definite ifthe
`
`specification "provides some standard for measuring that degree .... that is,
`
`whether one of ordinary skill in the art would understand what is claimed
`
`when the claim is read in light of the specification."). As discussed above,
`
`w1der the proper interpretation of the term "uniform," the '5 88 patent
`
`provides no standard or guidance by which the term "substantially" can be
`
`measured or determined. Nor is there any intrinsic and/or extrinsic evidence
`
`relied upon by Patent Owner to show that such term has a known meaning in
`
`the art. Thus, we agree with the Examiner that such relative expression,
`
`amenable to any number of plausible claim constructions, is deemed
`
`indefinite within the meaning of 35 U.S.C. § 112, second paragraph.
`
`Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) ("[During
`
`prosecution of a patent application,] if a claim is amenable to two or more
`
`plausible claim constructions [upon giving it the broadest reasonable
`
`interpretation consistent with the Specification], the USPTO is justified in
`
`requiring the applicant to more precisely define the metes and bounds of the
`
`10
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`claimed invention by holding the claim unpatentable under 35 U.S.C. § 112,
`
`second paragraph, as indefinite."); see also In re Morris, 127 F.3d 1048,
`
`1056 (Fed. Cir. 1997) ("It is the applicants' burden to precisely define the
`invention, not the PTO's. See 35 U.S.C. § 112, if 2 .... [T]his section puts
`the burden of precise claim drafting squarely on the applicant.").
`
`Since we are unable to detennine an acceptable degree of
`
`agglomeration or degree of uniformity for any area of a given fi Im to be
`
`considered "substantially unifonn," we decline to reach the question of
`
`whether the '588 patent provides written descriptive support and an enabling
`
`disclosure under 35 U.S.C. § 112, first paragraph. In re Wilson, 424, F.2d
`
`1382, 1385 (CCPA 1970); In re Steele, 305 F.2d 859, 862 (CCPA 1962).
`
`However, we will address the propriety of the certain prior art rejections
`
`maintained by the Examiner for the sake of administrative and judicial
`
`efficiency because we need not understand the exact scope of "substantially
`
`uniform" to resolve certain prior art rejections and/or can give a certain
`
`conditional interpretation of "substantially uniform" to resolve certain prior
`
`art rejections as is readily apparent from the discussions below. See, e.g.,
`
`Ex parte Saceman, 27 USPQ2d 1472, 1474 (Bd. Pat. App. & Int. 1993);
`
`Ex parte Ionescu, 222 USPQ 537, 540 (Bd. Pat. App. & Int. 1984).
`
`REJECTIONS BASED ON CHEN
`Claims 192 and 193 stand rejected under 35 U.S.C. § 102(b) as being
`anticipated by Chen. 3 Claim 1 and the claims that depend therefrom stand
`
`3 WO 00/42992, published July 27, 2000, naming Li-Lan Chen et al. as
`inventors.
`
`11
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`rejected under 35 U.S.C. § 102(b) as anticipated by or, in the alternative,
`under 35 U.S.C. § 103(a) as obvious over Chen, either alone or view of
`additional prior art. 4 Patent Owner does not argue for the separate
`
`patentability of any dependent claims. Accordingly, the dependent claims
`
`stand or fall with claim 1.
`
`Patent Owner contends that Chen fails to disclose a step of removing
`
`the polar solvent "by exposing the matrix to a temperature greater than the
`
`degradation temperature of said therapeutic active composition," as recited
`in claim 1. 5 Patent Owner argues that Chen teaches away from drying a film
`
`at a temperature above the degradation temperature of the therapeutic active
`
`composition. PO App. Br. 25-27. Patent Owner relies on the statement in
`
`Chen that the film is "dried under aeration at a temperature between 40-
`
`100°C so as to avoid destabilizing the agents contained within the
`
`formulation." Id. at 27; Chen, p. 15, 11. 19-29. Patent Owner argues that by
`
`this statement "Chen says such temperatures should be avoided" and that
`
`"Chen is concerned about keeping the temperature low to avoid destabilizing
`
`active agents." App. Br. 26 and 27.
`
`4 Other additional art combined with Chen includes Le Person (Le Person,
`et al., "Near infrared drying of phannaceutical thin films: experimental
`analysis of internal mass transport," Chem. Eng. Processing, Vol. 3 7,
`pp. 257-263 (1998)), Bernstein (US 5,656,297, issued August 12, 1997),
`Staab (US 5,393,528, issued February 28, 1995) and Hijiya (US 4,562,020,
`issued December 31, 1985).
`5 Patent Owner does not present separate the arguments with respect to
`claims 1, 192, and 193. However, only claim 1 includes a requirement that
`the temperature be greater than the degradation temperature of the
`therapeutic active composition.
`
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`We disagree with Patent Owner that Chen's statement suggests that
`
`higher temperatures "should be avoided" or "keeping the temperature low."
`
`Rather, Chen teaches a temperature range in order "to avoid destabilizing the
`
`agents contained within the formulation." Chen, p. 15, 11. 28-29. We
`
`disagree with Patent Owner that this statement would have suggested the
`
`skilled artisan limit the drying temperature to any particular temperature
`
`within the recited range of 40-100°C, provided that the film does not, in fact,
`
`result in degraded active ingredients. Thus, we find this statement in Chen
`
`consistent with the '588 patent. See '588 patent, col. 12, 11. 33-43.
`
`Moreover, we agree with the Examiner that the skilled artisan would
`
`"have optimized Chen's drying step by using as high a drying temperature as
`
`possible within Chen's disclosed the range of 40-100°C without
`
`destabilizing the active agent because temperature is a results-effective
`
`variable with respect to active agent destabilization as taught by Chen; and
`
`so as to dry Chen's film as quickly as possible." RAN 28-29 and 74. We
`
`note that the example in Chen of drying for only 9 minutes (Chen, p. 17,
`
`11. 13-15) is consistent with the description in the '588 patent of "drying the
`
`film within about 10 minutes or fewer." '588 patent, col. 7, 11. 33-35; see
`
`RAN 74. Patent Owner has not persuasively rebutted the Examiner's
`
`rationale as to the skilled artisan's reasonable optimization of temperatures
`
`within the range disclosed in Chen.
`
`With respect to all of the claims on appeal, Patent Owner contends
`
`that Chen fails to disclose a film having a "substantially unifon11 content of
`
`therapeutic active composition per unit of film." According to Patent
`
`Owner, Chen does "not indicate or establish that the substantially uniform
`
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
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`content of the components is such that, for example, the amount of the active
`
`in individual dosage units varies by no more than 10% with respect to the
`
`desired/label amount for a particular film." App. Br. 28. Patent Owner
`
`argues that "[t]he actual degree of uniformity must be established through a
`
`determination of the actual amount of therapeutic active in at least samples
`
`of dosage units, which Chen does not disclose." Id. at 28 and 31-32. Patent
`
`Owner further argues that Figure 5 of Chen demonstrates that "in six
`
`instances the amount of active released from Chen's films is greater than
`
`110% of the expected/desired amount." Id. at 30; Reb. Br. 5-6.
`
`Initially, we note that Patent Owner's arguments substantially rely on
`
`Patent Owner's proposed claim interpretation which emphasizes unifonnity
`
`with respect to a FDA-recognized dosage. For example, Patent Owner
`
`emphasizes a lack of evidence to support that the films of Chen are
`
`inherently within l Oo/o of a recognized FDA dosage. Reb. Br. 5-6 Also,
`
`Patent Owner's arguments with respect to Figure 5 are exclusively related to
`
`release of an amount of active being more than 110% of "an
`
`expected/desired amount of pharmaceutical active for that drug." Reb. Br. 5.
`
`We did not adopt the Patent Owner's proposed claim interpretation for
`
`the reasons discussed above and determine that the term "uniform content of
`
`therapeutic active composition" means non-agglomerated and evenly
`
`dispersed active content for any area of a given film, with the qualifier
`
`"substantially" expanding the scope to encompass some undefined
`
`agglomeration or some undefined degree of unevenly dispersed active
`
`material to also be acceptable. Accordingly, we do not find Patent Owner's
`
`arguments, including those regarding the release data over time in Figure 5
`
`14
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`

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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`of Chen, to be compelling of a lack of unifon11ity. Figure 5 does not suggest
`
`agglomerated or unevenly dispersed active content for any area of a given
`
`film. Figure 5 merely indicates that different amounts of active material
`
`releases from the Chen films at various times, which is not shown to be an
`
`indicator that the active material is agglomerated or unevenly dispersed.
`
`We agree with the Examiner that there is sufficient evidence to find
`
`that Chen inherently discloses a film with a substantially uniform content of
`
`therapeutic active composition per unit of film. RAN 21, 69-73 , and 75.
`
`In a case such as this where patentability rests upon a property of the
`
`claimed material not disclosed within the art, the PTO has no reasonable
`
`method of detennining whether there is, in fact, a patentable difference
`
`between the prior art materials and the claimed material. Therefore, where
`
`the claimed and prior art products are identical or substantially identical, or
`
`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 re Spada, 911 F .2d
`
`705, 708 (Fed. Cir. 1990); In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
`
`However, the initial burden of presenting a case of unpatentability remains
`
`with the Requester and Examiner. If that burden is met, only then does the
`
`burden of coming forward with evidence or argument shift to the Patent
`
`Owner. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
`
`Although Patent Owner argues that the drying process of Chen is a
`
`conventional drying method that is distinguishable from the drying process
`
`of the '588 patent (App. Br. 29; Reb. Br. 14-15), we find that Chen describes
`
`15
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
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`a substantially identical process to that described in the '588 patent. RAN
`
`70 and 75.
`
`Claim I does not recite any particular film drying steps. The evidence
`
`does not support Patent Owner's contention that the processes disclosed in
`
`Chen and in the '588 patent are clearly distinguishable. The '588 patent
`
`describes its drying process generally and does not clearly identify how a
`
`drying step can vary from a conventional drying process and avoid
`
`agglomerations of the active ingredients. For example, the '588 patent states
`
`that agglomerations form from "conventional drying methods such as a
`
`high-temperature air-bath using a drying oven, drying tunnel, vacuum drier,
`
`or other such drying equipment." However, the description of non(cid:173)
`
`agglomerating drying methods in the '588 patent does not clearly distinguish
`
`such drying equipment. See col. 14, 11. 13-14 ("the inventive process is not
`
`limited to any particular apparatus for the above-described desirable
`
`drying."). The '588 patent is not limited to any particular drying methods
`
`but rather includes a variety of drying methods. Id. col. 7, 11. 6-25; col. 25,
`
`11. 15-16 ("When a controlled or rapid drying process is desired, this may be
`
`through a variety of methods."). The only process clearly distinguished by
`
`the '588 patent is "uncontrolled air currents, either above or below the film"
`
`which "can create non-uniformity in the final film product." Id. , col. 7,
`
`11. 19-21; see also col. 6, 11. 50-61; col. 12, 11. 47-57 ("The films are
`
`Controllably dried to prevent aggregation and migration of components, as
`
`well as preventing heat build up within."); col. 10, 1. 67-col. 11 , 1. 4; col. 13,
`
`11. 13-15; col. 25, 11. 2-8. The ' 588 patent does not exclude top air flow
`
`(id. at col. 11, 11. 6-23) nor does the '588 patent require bottom directed
`
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`Appeal 2014-000547
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`Patent 7 ,824,588 B2
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`drying, since it only describes this process as either exemplary or preferable.
`
`See id. at col. 6, 11. 53-58; col. 7, 11. 6-8; col. 12, 11. 56-57; col. 25, 11. 22-23.
`
`Chen describes a process in which a film is dried in a "drying oven
`
`with aeration controller" as illustrated in Figure 2. Chen, p. 6, 1. 2. Figure 2
`
`is reproduced below.
`
`MIXING MID DEGASSlt~G TANK 8
`
`FfG.2
`
`Figure 2 depicts a schematic of a manufacturing process for a dosage
`
`unit. Chen, p. 5, I. 31-p. 6, I. 3.
`
`Figure 2 shows that at the initial drying stage, air currents are not
`
`directed onto the top of the film. Thus, we find that Chen teaches controlled
`
`drying and avoiding air currents directed onto the top surface of a film. The
`
`drying process of Chen is not sufficiently distinguished from the general
`
`drying method of the '5 88 patent.
`
`17
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`Appeal 2014-000547
`Reexamination Contra 1 951001, 7 53
`Patent 7 ,824,588 B2
`
`Patent Owner's position is supported by the testimony of Dr. Rounds,6
`
`who testifies that Chen uses "a high presence of air flowing over the
`
`surface(s) of the wet film product" and that "uneven air currents flow[ing]
`
`over the wet film surface ... can cause disruption of the fluid matrix and the
`
`components held therein, causing compositional non-uniformity of active
`content in the final, resulting film product." Rounds Deel. if 16. We give
`little weight to Dr. Rounds' testimony because neither the "hot air
`
`circulating oven" nor the controlled air flow of Chen is distinguished from
`
`the equipment of the '588 patent. Dr. Rounds does not address Figure 2
`
`which appears to show air diverted from the wet film surface consistent with
`
`the requirement for "controlled drying" in the '588 patent.
`
`Moreover, the Examiner also finds that Chen's Table 4 describes
`
`weight per dosage film, thickness, density and water content measurements
`
`with minimal deviation as evidence that substantially uniform content of
`
`therapeutic active is inherent in the films described by Chen. RAN 15 and
`
`71; see Chen p. 20, Table 4. The measured weight per dosage film as
`
`described in Chen is consistent with the additive weight test described in the
`
`'588 patent for determining uniformity. Specifically, the '588 patent states:
`
`"when the components of different densities are combined in a uniform
`
`manner in a film , as in the present invention, individual dosages fom1s from
`
`the same film of substantially equal dimensions, will contain the same
`
`mass." '588 patent, col. 29, 11. 4-9. Be