Ex Parte 7,824,588 et alDownload PDFPatent Trial and Appeal BoardApr 17, 201495001753 (P.T.A.B. Apr. 17, 2014) Copy Citation 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. 95/001,753 09/12/2011 7,824,588 117744-00016 6620 23869 7590 04/17/2014 Hoffmann & Baron LLP 6900 Jericho Turnpike Syosset, NY 11791 EXAMINER DIAMOND, ALAN D ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 04/17/2014 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) 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 Reexamination Control 95/001,753 Patent 7,824,588 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 7,824,588 B2 (herein after the “’588 patent”). 1 1 The ’588 patent issued November 2, 2010, to Robert K. Yang, et al. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 2 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 ’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 forming a rapidly dissolving film containing an active ingredient evenly or uniformly distributed throughout the film. ’588 patent, col. 1, ll. 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 formation and the use of a drying process that reduces Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 3 aggregation or conglomeration of the components in the film as it forms into a solid structure.” Id. at col. 1, ll. 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 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) Removing said polar solvent from said matrix with heat and/or radiation energy by exposing said matrix to a Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 4 temperature greater than the degradation temperature of said therapeutic active composition to form a self-supporting film; wherein the temperature of the matrix is 100° 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: (a) 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) 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 form a viscoelastic film; wherein the resulting viscoelastic film maintains the substantially uniform content of therapeutic active composition per unit of film. 193. 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 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 forming bubbles; Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 5 wherein the resulting self-supporting film maintains the substantially uniform content of therapeutic active composition 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 uniform 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 1. 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 claim 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 uniform’. ‘Substantially uniform’ is not defined in the ’588 patent.” Id. at 68-69. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 6 Patent Owner argues that the phrase “substantially uniform content of therapeutic active composition” means “a film having a degree of uniformity of ± 10% from the FDA 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 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. ’588 patent, col. 2, ll. 25-44. We disagree with the Patent Owner’s interpretation of the phrase “substantially uniform content of therapeutic active composition.” The 2 Cf. App. Br. 24 (defining the phrase as “a degree of uniformity 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 term 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 of uniformity consistent with FDA pharmaceutical 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.”). Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 7 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, ll. 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, ll. 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 normally experienced when films are formed by conventional drying methods.” Id., col. 6, ll. 25- 32. The process of the ’588 patent provides “uniform distribution of components for any given area in the film.” Id. at col. 7, ll. 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 uniformity 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 Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 8 upon by the Patent Owner, stating that uniformity is “virtually mandated” by FDA 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, ll. 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 forms. Id. at col. 28, ll. 10-16. Table 2 shows that with each additional dosage form, the weight increased by exactly 0.04g. Id. at col. 28, ll. 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, ll. 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 Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 9 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, ll. 10-12. 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, ll. 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 “uniform” 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 Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 10 a degree of agglomeration or an amount of unevenly dispersed active material for which the film 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 uniformity. Words of degree may lack precision, but they do not necessarily render a claim indefinite. Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984) (A term of degree is definite if the 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, under the proper interpretation of the term “uniform,” the ’588 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 Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 11 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, ¶ 2 . . . . [T]his section puts the burden of precise claim drafting squarely on the applicant.”). Since we are unable to determine an acceptable degree of agglomeration or degree of uniformity for any area of a given film to be considered “substantially uniform,” 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. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 12 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, ll. 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 pharmaceutical thin films: experimental analysis of internal mass transport,” Chem. Eng. Processing, Vol. 37, 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. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 13 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, ll. 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, ll. 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, ll. 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, ll. 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 uniform content of therapeutic active composition per unit of film.” According to Patent Owner, Chen does “not indicate or establish that the substantially uniform Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 14 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 uniformity 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 10% 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 Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 15 of Chen, to be compelling of a lack of uniformity. 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 determining 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 Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 16 a substantially identical process to that described in the ’588 patent. RAN 70 and 75. Claim 1 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- agglomerating drying methods in the ’588 patent does not clearly distinguish such drying equipment. See col. 14, ll. 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, ll. 6-25; col. 25, ll. 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, ll. 19-21; see also col. 6, ll. 50-61; col. 12, ll. 47-57 (“The films are Controllably dried to prevent aggregation and migration of components, as well as preventing heat build up within.”); col. 10, l. 67-col. 11, l. 4; col. 13, ll. 13-15; col. 25, ll. 2-8. The ’588 patent does not exclude top air flow (id. at col. 11, ll. 6-23) nor does the ’588 patent require bottom directed Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 17 drying, since it only describes this process as either exemplary or preferable. See id. at col. 6, ll. 53-58; col. 7, ll. 6-8; col. 12, ll. 56-57; col. 25, ll. 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, l. 2. Figure 2 is reproduced below. Figure 2 depicts a schematic of a manufacturing process for a dosage unit. Chen, p. 5, l. 31-p. 6, l. 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 ’588 patent. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 18 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 Decl. ¶ 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 forms from the same film of substantially equal dimensions, will contain the same mass.” ’588 patent, col. 29, ll. 4-9. Because the claims require only a “substantially uniform” film, which is broader than complete uniformity, but 6 Declaration of Rhyta S. Rounds, dated January 9, 2012 and entered into the record on January 10, 2012 with Patent Owner’s Response (hereinafter “Rounds Declaration” or “Rounds Decl.”). Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 19 indefinite as to the degree of agglomeration or unevenly dispersed active material that would still be considered substantially uniform, for the purpose of applying art to the claims, we find that a weight deviation of ± 0.001 satisfies the limitation of “substantially uniform” active content. This amount is well within the less than 10% variation of active content per film unit requirement of claim 3. 7 Patent Owner does not persuasively show a distinction between the additive weight test of the ’588 patent and the consistent weight measurements of Chen. Accordingly, the Examiner’s finding of inherency based on the processes of Chen and the ’588 patent being “substantially identical” is supported by the evidence of record, as well as the Examiner’s finding that Chen teaches films with consistent weight per unit film. Accordingly, the burden was properly shifted to Patent Owner to demonstrate that the process of Chen does not, in fact, teach a film having a substantially uniform content of therapeutic active composition per unit of film. REJECTIONS BASED ON PEH Claims 192 and 193 stand rejected under 35 U.S.C. § 102(b) as being anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Peh, 8 either alone or in view of additional prior art. 9 7 While Patent Owner does not clearly argue the limitation of claim 3 separately from independent claims 1, 192 and 193, we note that Patent Owner refers to claim 3 in distinguishing the scope over that of claim 1. App. Br. 23; Reb. Br. 3. 8 Kok Khiang Peh et al., “Polymeric Films as Vehicle for Buccal Delivery: Swelling, Mechanical, and Bioadhesive Properties,” J. Pharm. Pharmaceut. Sci., Vol. 2, No. 2, pp. 53-61 (1999). Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 20 In affirming the rejection of claims 192 and 193 as anticipated by Chen under 35 U.S.C. § 102(b) and as unpatentable under 35 U.S.C. § 112, it is unnecessary to address the additional rejections maintained by the Examiner for claims 192 and 193. See In re Gleave, 560 F.3d 1331, 1338 (Fed. Cir. 2009) (holding that obviousness rejections need not be reached upon affirming a rejection of all claims as anticipated). SUMMARY For the reasons discussed above, we affirm the Examiner’s rejections of: 1. 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, under 35 U.S.C. § 112, as being indefinite; 2. Claims 25-28, 30-33, 35, 36, 40, 42-53, 55-58, 60, 61, 65, 67-74, 76, 77, 79, 80, 82, 83, 85, 86, 88, 89, 91, 92, 94, 95, 97, 98, 100, 101, 103, 104, 107-110, 133-139, 141-143, 155-161, 163-165, 179- 182, 184, 185, 187, 188, 190-193 under 35 U.S.C. § 102(b) as being anticipated by Chen; 3. Claims 1-3, 5-8, 10, 11, 15, 17-24, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 106, 111-117, 119-121, 177, 178, 183, 186, and 189 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; 4. Claims 4, 14, 29, 39, 54, 64, 118, 140, and 162 under 35 U.S.C. § 103(a) as being unpatentable over Chen; 5. Claims 1, 122-132, 144-154 and 166-176 under 35 U.S.C. § 103(a) as being unpatentable over the combination of Chen and Le Person; 6. Claims 2, 5, 8, 9, 12, 15, 16, 18, 34, 37, 41, 59, 62, 66, 84, 99, 113, and 121 under 35 U.S.C. § 103(a) as being unpatentable over the combination of Chen and Bernstein; 9 Other additional art combined with Peh includes Le Person, Staab, Chen, Strobush (U.S. 5,881,476, issued March 16, 1999), Bernstein, and Hijiya. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 21 7. Claims 13, 14, 17, 38, 39, 42, 63, 64 and 67 under 35 U.S.C. § 103(a) as being unpatentable over Chen in combination with Staab or Hijiya; 8. Claims 2, 5, 8, 15, 84, 99 and 113 under 35 U.S.C. § 103(a) as being unpatentable over the combination of Chen and Hijiya. For the reasons discussed above, we do not reach the Examiner’s rejections based on 35 U.S.C. § 112, first paragraph, or the Examiner’s rejections based on the teachings of Peh alone or in view of additional prior art. TIME PERIOD FOR RESPONSE In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the appeal may file a request for rehearing of the decision within one month of the date of: . . . [t]he original decision of the Board under § 41.77(a).” A request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). Comments in opposition to the request and additional requests for rehearing must be in accordance with 37 C.F.R. § 41.79(c) & (d), respectively. Under 37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) of this section, for requesting further rehearing under paragraph (d) of this section, and for submitting comments under paragraph (c) of this section may not be extended. An appeal to the United States Court of Appeals for the Federal Circuit under 35 U.S.C. §§ 141-144 and 315 and 37 C.F.R. § 1.983 for an inter partes reexamination proceeding “commenced” on or after November 2, 2002 may not be taken “until all parties’ rights to request rehearing have been exhausted, at which time the decision of the Board is final and appealable by any party to the appeal to the Board.” 37 C.F.R. Appeal 2014-000547 Reexamination Control 95/001,753 Patent 7,824,588 B2 22 § 41.81. See also MPEP § 2682 (8th ed., Rev. 7, July 2008). In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. AFFIRMED ak PATENT OWNER: Hoffmann & Baron, LLP 6900 Jericho Turnpike Syosset, NY 11791 THIRD-PARTY REQUESTER: McCarter & English, LLP 265 Franklin Street Boston, MA 02110 Copy with citationCopy as parenthetical citation