Ex Parte Angel et alDownload PDFPatent Trial and Appeal BoardFeb 7, 201712065525 (P.T.A.B. Feb. 7, 2017) 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. 12/065,525 03/03/2008 Maximilian Angel 074008-0648-US (286092) 1578 123223 7590 02/09/2017 Drinker Biddle & Reath LLP (WM) 222 Delaware Avenue, Ste. 1410 Wilmington, DE 19801-1621 EXAMINER MERCIER, MELISSA S ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 02/09/2017 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): IPDocketWM @ dbr.com penelope. mongelluzzo @ dbr. com DB RIPDocket @ dbr. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MAXIMILIAN ANGEL and KARL KOLTER Appeal 2016-003741 Application 12/065,525 Technology Center 1600 Before DONALD E. ADAMS, RICHARD J. SMITH, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134(a) involves claims 17, 19-24, and 26—38 (Br. 3). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellants identify the real party in interest as “BASF SE” (Br. 2). Appeal 2016-003741 Application 12/065,525 STATEMENT OF THE CASE Appellants’ disclosure “relates to polyvinyl acetate dispersions with improved shear stability and to a process for preparing such dispersions” (Spec. 1: 5—6). Claims 17, 23, 30-32, 35 are representative and reproduced below: 17. An aqueous polymer dispersion prepared by a process comprising: providing a monomer composition comprising a vinyl acetate monomer component and second monomer component comprising an additional monomer selected from the group consisting of acrylic acid, methacrylic acid and mixtures thereof in an amount of 0.1 to 0.6% by weight, wherein the vinyl acetate monomer component and the second monomer component comprise 100% by weight of the monomer composition; and ffee-radically polymerizing the monomer composition in the presence of 0.1 to 0.5% by weight of an ionic emulsifier, based on the weight of the monomer composition. (Br. 18.) 23. The aqueous polymer dispersion according to claim 17, further comprising a protective colloid. (Id.) 30. A polymer in powder form prepared by a process comprising drying an aqueous polymer dispersion according to claim 17. (Id. at 19.) 31 A pharmaceutical or cosmetic formulation comprising an aqueous polymer dispersion according to claim 17. (Id.) 32. A pharmaceutical or cosmetic formulation comprising a powdered polymer according to claim 30. (Id. at 20.) 2 Appeal 2016-003741 Application 12/065,525 35. A delayed-release pharmaceutical formulation comprising at least one active pharmaceutical ingredient coated with a film prepared from an aqueous polymer dispersion according to claim 17. (Id.) The claims stand rejected as follows: Claims 17, 19—22, 26—28, 31, 33, and 37 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey2 and Brown.3 Claims 32 and 34—36 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey, Brown, and Hotko.4 Claims 23, 24, 28—30, and 38 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey, Brown, Hotko, and Kolter.5 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Corey “relates to polyvinyl acetate lattices in which the polymer particles are of ultra fine size, a characteristic which in combination with high polymer molecular weight renders polyvinyl acetate available for uses 2 Corey et al., US 3,245,936, issued Apr. 12, 1966. 3 Brown, US 6,306,952 Bl, issued Oct. 23, 2001. 4 Hotko et al., US 3,325,365, issued June 13, 1967. 5 Kolter et al., WO 02/26845 Al, published Apr. 2, 2002. Examiner relied upon Kolter et al., US 7,094,831 B2, issued Aug. 22, 2006 “as an English translation of WO 02/26845 [Al]” (see Ans. 7). 3 Appeal 2016-003741 Application 12/065,525 hitherto beyond its compass” (Corey 1: 10-14; see generally Final Act.6 5 (“Corey [] taught there were [] uses other than for the purpose of coating paper”); see Corey 1: 40-44 (Although “the observations, [] concepts and [] methods that follow will be presented in their relation to mineral printing paper coating, one of the most important commercial uses for the new lattices. There are other[]” uses for the lattices disclosed by Corey)). FF 2. Corey discloses that the “lattices are formed by the polymerization of vinyl acetate monomer in aqueous emulsion at a temperature sensibly lower than that normally necessary for such polymerization reaction to occur within an economically reasonable period, such a temperature becoming functional through the agency of a free radical producing redox initiator” (Corey 3: 9-15). FF 3. Corey discloses: 1. A stable aqueous latex comprising as essential constituents 30 to 55 % by weight of a resinous binder which is the polymerized produce of a monomer mixture, consisting of [(a)] vinyl acetate and [(b)] 0.5 to 3.0%, based on the total monomer mixture weight, of acrylic acid, and from about 1 to 5% by weight, based on the latex weight, of emulsifier [/surfactant]; wherein the diameter of the polymer particles is smaller than the wavelength of visible light. (Corey 8: 48—55 (Corey’s claim 1) (emphasis added);; see Final Act. 2-4; Final Act. 3 (Examiner reasons that, because “the monomer mixture ‘consists’ of [vinyl acetate and acrylic acid] these two types of monomers . . . comprise 100% by weight of the monomer composition (see also [Corey’s] Example 1, at column 4, where the only two polymerizable monomers are vinyl acetate and acrylic acid)); Final Act. 3, citing Corey 4: 9-21 (for a 6 Examiner’s Final Office Action mailed Jan. 29, 2015. 4 Appeal 2016-003741 Application 12/065,525 disclosure of a polyvinyl acetate latex prepared from ingredients wherein vinyl acetate and acrylic acid are “the only two polymerizable monomers” in the composition.) FF 4. Corey discloses: It has been found that in the exercise of [Corey’s] invention the best results are obtained when the polymerized vinyl acetate contains from 1.0 to \.5% of acrylic acid, based on the total weight of the monomers. Satisfactory stabilization and increased adhesion to substrates may be obtained, however, with any acrylic acid content within the range of 0.5 to 3.0 %. (Corey 7: 22-28.) FF 5. Corey discloses “[a] printing paper coating composition comprising essentially an aqueous pigment suspension and the latex of claim 1, in proportions such that there are 3 to 25 parts by weight of the resinous binder for each 100 parts of pigment, on a dry basis” (Corey 8: 61—65 (Corey’s claim 3); see Final Act. 3; Final Act. 4 (Examiner reasons that “[although Corey [discloses] a printing paper coating composition, it is submitted that one could also apply such a composition to one’s skin, if desired; hence [Corey suggests] a ‘cosmetic formulation’ comprising pigment”)). FF 6. Corey discloses that [t]he surfactants usable in [Corey’s] formulations may be anionic, cationic or nonionic [and that] [variations in the type and amount of [surfactants] will influence the stability of the emulsions as well as the progress of the polymerization in known manner but the effect of such variations is not contemplated as part of [Corey’s] invention, except as further influenced by the action of the acrylic acid. (Corey 7: 34^42; Final Act. 4.) 5 Appeal 2016-003741 Application 12/065,525 FF 7. Examiner finds that Corey fails to disclose a composition comprising an ionic emulsifier in the range of 0.1 to 0.5% and relies on Brown to make up for this deficiency in Corey (Final Act. 4). FF 8. Brown discloses “coating compositions having a low [volatile organic components (VOC)] content and which are quick to dry but easy to apply, [as well as,] their preparation and use” (Brown 1: 9-11; see generally Final Act. 4). FF 9. Brown discloses that “vinyl acetate copolymers are well-known and include copolymers such as vinyl acetate/butyl acrylate/2-ethylhexyl acrylate, vinyl acetate/butyl maleate, vinyl acetate/ethylene, vinyl acetate/vinyl chloride/butyl acrylate and vinyl acetate/vinyl chloride/ethylene” (Brown 7: 45 49; Final Act. 4). FF 10. Brown discloses that “[t]he polymerization techniques used for preparing the latex binder of [Brown’s] invention are well known in the art. The binder may be prepared by emulsion or solution polymerization, preferably by free-radical initiation” (Brown 8: 6—9; Final Act. 4). FF 11. Brown discloses that “[w]hen the latex binder in the form of a dispersed polymer is utilized, the polymer particle size is controlled by the amount of conventional surfactants added during the emulsion polymerization process,” that “[conventional surfactants include anionic, nonionic emulsifiers or their combination,” and that “[t]ypical ranges for surfactants are between 0.1 to 6 percent by weight based on the total weight of the monomer mixture” (Brown 8: 47—51 and 63—65; Final Act. 4). FF 12. Examiner finds that the combination of Corey and Brown fails to suggest “a delayed release pharmaceutical formulation” and relies on Hotko 6 Appeal 2016-003741 Application 12/065,525 to make up for this deficiency in the combination of Corey and Brown (Final Act. 5). FF 13. Hotko “relates to a process for coating tablets, and in particular to a process for the compression coating of tablets with an enteric coating containing a film-forming copolymer” (Hotko 1: 10—13; Final Act. 5). FF 14. Hotko’s “tablets can be compressed coated with an enteric coating by using an enteric coating granulate composition containing a polyvinyl acetate copolymer as the film-forming copolymer and a substrate” (Hotko 2: 54—57; Final Act. 5—6). FF 15. Hotko discloses that “[t]he polyvinyl acetate copolymer[ is] prepared according to known methods [ and] is made up of two comonomers, one of which is[] vinyl acetate monomer” and the other monomer is preferably a compound “having [an] acrylic acid moiety” (Hotko 3: 8—19). FF 16. Hotko’s “objective] is to obtain a coating impermeable to gastric fluids, which, however, erodes or yields the core contents in the intestinal tract” (Hotko 2: 2-4; Final Act. 5 (Examiner interprets Hotko’s disclosure to read on “a ‘delayed-release’ formulation”). FF 17. Hotko discloses that “a plasticizer [may be, if desired,] added to the granulate composition to give the enteric coating the desired plasticity” (Hotko 3: 46-47; Final Act. 6). FF 18. Examiner finds that “whether the aqueous polymer of Corey had been dried to a powder form or not, the finished product (i.e. the coated tablet of Hotko made with the polymer of Corey) would be of the same composition and structure” (Final Act. 6). FF 19. Examiner finds that the combination of Corey, Brown, and Hotko does not suggest “a ‘protective colloid’” or “drying [the] aqueous polymer 7 Appeal 2016-003741 Application 12/065,525 dispersion” and relies on Kolter to make up for this deficiency in the combination of Corey, Brown, and Hotko (Final Act. 7). FF 20. Kolter “relates to an aqueous polymer dispersion prepared by free- radical polymerization of vinyl acetate, to a process for preparing an aqueous polymer dispersion of this type, and to the use thereof’ (Kolter 1: 3—6; see generally Final Act. 7). FF 21. Kolter discloses: It is an object of [Kolter’s] invention to provide starting materials for producing in particular pharmaceutical dosage forms, which are very stable on storage, which can be processed very easily, which in particular easily result in good, homogeneous film coatings with very reproducible release and which, where appropriate, need not be prepared from powders which are initially dried and then redispersed in H20. (Kolter 2: 26—33; Final Act. 8.) FF 22. KoIter’s objective] is achieved by an aqueous polymer dispersion prepared by free-radical polymerization of vinyl acetate in the presence of at least one ionic emulsifier, at least one free- radical initiator and at least one protective colloid, wherein the polymerization is carried out in the presence of a polymerization regulator and wherein the ratio by weight of protective colloid to ionic emulsifier is at least 4:1, preferably at least 8:1, particularly preferably in the range between 8:1 and 12:1, and wherein the ratio by weight of vinyl acetate monomer to protective colloid is between 19:1 and 4:1, preferably between 15:1 and 6:1. (Kolter 2: 34-44; Final Act. 8—9.) FF 23. Kolter discloses “aqueous polymer dispersions” and “polymer powders produced therefrom in a conventional way” (Kolter 4: 30-32; see Final Act. 9). 8 Appeal 2016-003741 Application 12/065,525 ANALYSIS The combination of Corey and Brown: Based on the combination of Corey and Brown, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to modify the compositions and processes disclosed by Corey from 1% to 0.5% emulsifier, [because] both Corey and Brown taught the amount of emulsifier to be a results-effective variable and thus subject to routine optimization” (Final Act. 4—5). See In re Alter, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”). Claim 17: Corey claims a composition comprising “0.5 to 3.0%, based on the total monomer mixture weight, of acrylic acid” (FF 3) and discloses that “[satisfactory stabilization and increased adhesion to substrates may be obtained, however, with any acrylic acid content within the range of 0.5 to 3.0% (FF 4). The range of 0.5 to 3.0% overlaps the concentration of acrylic acid required by Appellants’ claimed invention. Overlapping ranges support a prima facie case of obviousness. See In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997). Therefore, we are not persuaded by Appellants’ contentions regarding Corey’s disclosure of “[t]he best results” or that Corey “teaches away” from Appellants’ acrylic acid concentration (Br. 11). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). 9 Appeal 2016-003741 Application 12/065,525 We are not persuaded by Appellants’ contention that modifying the amount of emulsifier in Corey’s composition “would be in direct contradiction to the express teachings of Corey which specifies much higher amounts of emulsifier” (Br. 12). To the contrary, Corey discloses variations in the amount of emulsifier and discloses that such “[variations in the type and amount of [surfactants] will influence the stability of the emulsions as well as the progress of the polymerization in known manner’’ (FF 6 (emphasis added)). In this regard, Brown discloses that “polymer particle size is controlled by the amount of conventional surfactants added during the emulsion polymerization process,” and that “[tjypical ranges for surfactants are between 0.1 to 6 percent by weight based on the total weight of the monomer mixture” (FF 11). Therefore, notwithstanding Appellants’ contention to the contrary, we find no error in Examiner’s conclusion that “it is not inventive to discover the optimum or workable ranges by routine experimentation” (Final Act. 5, citing Alien, 220 F.2d at 456; cf. Br. 12). We recognize Appellants’ assertion “that both Corey and Brown are concerned with controlling particle size” (Br. 12). We are not, however, persuaded by Appellants’ contention that Examiner’s conclusion of obviousness is in error, because “controlling particle size ... is not the inventive concept of [Appellants’] claimed invention” (id.). In re Beattie, 91A F.2d 1309, 1312 (Fed. Cir. 1992) (“[T]he law does not require that the references be combined for the reasons contemplated by the inventor”). Therefore, we are not persuaded by Appellants’ contentions regarding “shear-stability of the dispersion,” which is not required by Appellants’ claim 17 (see Br. 11—12; cf. Br. 18 (Appellants’ claim 17)). 10 Appeal 2016-003741 Application 12/065,525 Claim 31\ While Corey exemplifies the use of Corey’s composition for coating paper, Corey expressly discloses that other uses are within the scope of Corey’s disclosure (FF 1). Examiner reasons that “[although Corey [exemplifies] a printing paper coating composition, it is submitted that one could also apply such a composition to one’s skin, if desired; hence [Corey suggests] a ‘cosmetic formulation’ comprising pigment” (FF 5). Thus, Examiner articulated a rationale with some rational underpinning that supports Examiner’s conclusion of obviousness. Cf. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). A fact-finder “need not seek out precise teachings directed to the specific subject matter of the challenged claim [in an analysis of obviousness], for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSRInt’lv. Teleflex Inc., 550 U.S. 398, 418 (2007). Appellants provide no persuasive evidence or argument to support a conclusion that a person of ordinary skill in this art would not have found it prima facie obvious to utilize the composition suggested by the combination of Corey and Brown as a cosmetic formulation or component thereof (see FF 5; cf. Br 13 (“[A]pellant[s] believe[] that there is no disclosure that the printing paper coating composition could be applied to a person’s skin. The Examiner has just asserted this statement without any basis”); Br. 14 (“There is nothing in Corey to indicate that the other uses can be pharmaceutical or cosmetic”)). “Attorney’s argument in a brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). For the foregoing reasons we are not persuaded by Appellants’ contention that Examiner’s conclusion of obviousness is based in hindsight (Br. 14). 11 Appeal 2016-003741 Application 12/065,525 The combination of Corey, Brown, and Hotko\ Based on the combination of Corey, Brown, and Hotko, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to use the polymer dispersion taught by Corey to provide the enteric coating taught by Hotko[, because] Hotko expressly suggested using a copolymer of vinyl acetate and [a compound having an] acrylic acid [moiety] as the enteric coating” (Final Act. 6). In this regard, Examiner reasons that “the selection of Corey’s vinyl acetate/acrylic acid copolymer would have represented nothing more than selecting a known material for its intended purpose” (id.). See KSR Int T Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”). Claims 32 and 34: Appellants correctly explain that Appellants’ claim 32 and 34 depend directly or indirectly from Appellants’ claim 30, which was not included in the rejections over: (i) Corey and Brown or (ii) Corey, Brown, and Hotko (Br. 14). Therefore, Examiner failed to establish a prima facie case of obviousness with respect to Appellants’ claims 32 and 34. Thus, we are compelled to reverse the rejection of claims 32 and 34 over the combination of Corey, Brown, and Hotko. Claim 35: For the reasons set forth above, we are not persuaded by Appellants’ arguments relating to claim 31 (“Group II”) (see Br. 15). In this regard, we are not persuaded by Appellants’ contention that “Corey does not disclose 12 Appeal 2016-003741 Application 12/065,525 polymers with a low content of emulsifier,” which fails to account for Brown’s contribution to the rejection over the combination of Corey, Brown, and Hotko (Br. 16). Similarly, we are not persuaded by Appellants’ contention that “Hotko is completely silent on the amount of acidic monomers” and “Hotko contains no information on the composition of the co-monomers,” which fails to account for the contribution of the combination of Corey and Brown, to the rejection over the combination of Corey, Brown, and Hotko. In this regard, we note that Hotko discloses that “[t]he polyvinyl acetate copolymer[ is] prepared according to known methods[ and] is made up of two comonomers, one of which is[] vinyl acetate monomer” and the other monomer is preferably a compound “having [an] acrylic acid moiety (FF 15 (emphasis added); cf. Br. 16). Hotko’s “objective] is to obtain a coating impermeable to gastric fluids, which, however, erodes or yields the core contents in the intestinal tract” (FF 16). Examiner interprets Hotko’s disclosure to read on “a ‘delayed-release’ formulation” (id.). We find no error in Examiner’s conclusion of obviousness. Appellants provide no persuasive evidence or argument to support a contrary conclusion (cf. Br. 16 (“[A]ppellant[s] do[] not believe that [Hotko’s disclosure] necessarily means that this is time release”)). “Attorney’s argument in a brief cannot take the place of evidence.” Pearson, 494 F.2d at 1405. The combination of Corey, Brown, Hotko, and Kolter. Based on the combination of Corey, Brown, and Hotko, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to modify the teachings of Corey and Hotko by 13 Appeal 2016-003741 Application 12/065,525 including a protective colloid during the polymerization process, [because] Kolter taught this provided the advantage of stability, easy processing, and good, homogeneous film coatings with very reproducible release” (Final Act. 9 ; see FF 21). Claim 23 is representative. Having found no error in the rejections over Corey and Brown with or without Hotko as they apply to Appellants’ claims 17, 31, and 35 we are not persuaded by Appellants’ reference to their foregoing arguments or contention that, because “the combination of Corey, Brown and Hotko does not lead to the claimed invention, the further combination with Kilter cannot render these claims obvious” (Br. 16). We are not persuaded by Appellants’ contention that “Kolter does not cure the deficiencies of Corey and Brown[, because Kolter] does not hint or suggest the combination of low emulsifier contents and low acrylic acid monomer contents,” which fails to account for the combination of Corey, Brown, and Hotko in the rejection over the combination of Corey, Brown, Hotko, and Kolter (see Br. 16). We recognize, but are not persuaded by Appellants’ contentions regarding “shear stability” which are not commensurate in scope with claim 23, which does not require any particular shear stability (see Br. 17; cf. Br. 18 (Appellants’ claim 23)). For the foregoing reasons, we are not persuaded by Appellants’ contention that Examiner’s conclusion of obviousness is based in hindsight (Br. 16). 14 Appeal 2016-003741 Application 12/065,525 CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness with respect to claims 17, 31, 35, and 23. The rejection of claims 17 and 31 under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey and Brown is affirmed. Claims 19-22, 26—28, and 37 fall with claim 17 (see Br. 7 (“Group I”). Claim 33 falls with claim 31 (see Br. 13 (“Group [II]”). The rejection of claim 35 under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey, Brown, and Hotko is affirmed. Claim 36 is not separately argued and falls with claim 35 (see Br. 14 (“Group IV”). The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey, Brown, Hotko, and Kolter is affirmed. Claims 24, 28—30, and 38 are not separately argued and fall with claim 23 (see Br. 16 (“Group V”). The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness with respect to claims 32 and 34. The rejection of claims 32 and 34 under 35 U.S.C. § 103(a) as unpatentable over the combination of Corey, Brown, and Hotko is reversed. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART 15 Copy with citationCopy as parenthetical citation