Fang Liu et al.Download PDFPatent Trials and Appeals BoardJul 22, 201913603984 - (D) (P.T.A.B. Jul. 22, 2019) 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. 13/603,984 09/05/2012 Fang LIU 000270US 5301 151167 7590 07/22/2019 Gruneberg and Myers PLLC 1775 Tysons Blvd 5th Floor Tysons, VA 22102 EXAMINER BARHAM, BETHANY P ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 07/22/2019 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): em@gandmpatent.com kg@gandmpatent.com patent@gandmpatent.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte FANG LIU, ABDUL W. BASIT, ROSARIO LIZIO, HANS-ULRICH PETEREIT, CHRISTIAN MEIER, and MICHAEL DAMM1 __________ Appeal 2018-004419 Application 13/603,984 Technology Center 1600 __________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. 1 Appellants identify the Real Party in Interest as EVONIK ROEHM GMBH. Appeal Br. 1. Appeal 2018-004419 Application 13/603,984 2 DECISION ON APPEAL This is an appeal2 under 35 U.S.C. § 134(a) involving claims to gastric resistant, enteric coated sold dosage forms which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).3 We AFFIRM-IN-PART. STATEMENT OF THE CASE “Enteric coated products are designed to remain intact in the stomach and then to release the active substance in the intestine. . . . The purpose of enteric coating is to protect the stomach from irritating active compounds such as aspirin, or to improve drug bioavailability by preventing degradation of acid or gastric enzyme labile drugs.” Spec. ¶ 2. An ideal enteric coating should possess the following properties: “1. Must resist disintegration or dissolution in the stomach for as long as the dosage form remains there; 2. Must dissolve or disintegrate rapidly in the small intestine; 3. Must be physically and chemically stable during storage; 4. Must be non-toxic; 5. Must be easily applied as a coating; 6. Must be economical.” Id. ¶ 3. The Specification describes “solid dosage forms with enteric coatings where the drug release is faster at lower pH compared to state of art solid dosage forms.” Id. ¶ 13. 2 We have considered and herein refer to the Specification of Sept. 5, 2012 (“Spec.”); Final Office Action of June 13, 2017 (“Final Act.”); Appeal Brief of Nov. 3, 2017 (“Appeal Br.”); Examiner’s Answer of Feb. 22, 2018 (“Ans.”); and Reply Brief Mar. 22, 2018 (“Reply Br.”). 3 Oral arguments were heard on July 2, 2019. A transcript of the hearing will be added to the record when it becomes available. Appeal 2018-004419 Application 13/603,984 3 Claims 63, 65, 66, 68–72, and 76–87 are on appeal. Claims 63 and 76 are the sole independent claims and read as follows: 63. A gastric resistant, enteric-coated solid dosage form comprising an inner coating located between a core containing a pharmaceutically active ingredient and an outer enteric coating; wherein said inner coating comprises a partially neutralized anionic polymeric material; wherein said inner coating further comprises at least one water soluble inorganic salt, wherein the cation of the inorganic salt is selected from the group consisting of alkali metal, alkaline earth metal, ammonium, manganese, iron, copper, zinc, and molybdenum cations, and the anion of the inorganic salt is selected from the group consisting of chloride, fluoride, bromide, iodide, nitrate, nitrite, and sulphate anions, with the proviso that carbonates and bicarbonates are excluded: and wherein said outer coating comprises an anionic polymeric material which is not neutralized or partially neutralized but less neutralized than the anionic polymeric material of the inner coating. 76. A gastric resistant, enteric-coated solid dosage form comprising an inner coating located between a core containing a pharmaceutically active ingredient and an outer enteric coating; wherein said inner coating comprises a partially neutralized anionic polymeric material; wherein said inner coating further comprises at least one water soluble inorganic salt, wherein the cation of the inorganic salt is selected from the group consisting of alkali metal, alkaline earth metal, ammonium, manganese, iron, copper, zinc, and molybdenum cations, and the anion of the inorganic salt is selected from the group consisting of chloride, fluoride, bromide, iodide, nitrate, nitrite, and sulphate anions, with the proviso that carbonates and bicarbonates are excluded: and wherein said outer coating comprises the same anionic polymeric material of the inner coating, with the proviso that the anionic polymeric material of the outer coating is not Appeal 2018-004419 Application 13/603,984 4 neutralized or less neutralized than the partially neutralized anionic polymeric material of the inner coating. The claims stand rejected as follows: Claims 63, 65, 66, 68, 69, 71, 72, 76–80, 82–84, and 86 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Patel4 as evidence by Rudolph5, in view of ACRYL-EZE6 and Oshlack.7 Claims 63, 65, 66, 68–72, and 76–87 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Patel as evidence by Rudolph, in view of ACRYL-EZE and Oshlack and in further view of Petereit.8 Claims 63, 65, 66, 68, 69, 71, 72, 76-80, 82–84, and 86 rejected under 35 U.S.C. § 103(a) as unpatentable over Patel as evidence by Rudolph, in view of ACRYL-EZE and Oshlack and in further view Degussa.9 PATEL COMBINED WITH ACRYL-EZE AND OSHLACK Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 63, 65, 66, 68, 69, 71, 72, 76–80, 82–84, and 86 would have been obvious over Patel combined with ACRYL-EZE and Oshlack. 4 Patel et al., US 2006/0210631 A1, published Sept. 21, 2006 (“Patel”). 5 Markus W. Rudolph et al., A new 5–aminosalicylic acid multi-unit dosage form for the therapy of ulcerative colitis, 51 Eur. J. Pharm. and Biopharm. 183 (2001)(“Rudolph”). 6 Colorcom, Acryl-EZE Product Information, (2013) (“ACRYL-EZE”). 7 Oshlack et al., US 5,639,476, issued June 17, 1977 (“Oshlack”). 8 Petereit et al., US 2005/0079216 A1, published Apr. 14, 2005 (“Petereit”) 9 Röhm Pharma Polymers Degussa, Enteric Coatings-pH control with EUDRAGIT®, 2002 (“Degussa”) Appeal 2018-004419 Application 13/603,984 5 The Examiner finds that Patel discloses “a gastric resistant, enteric- coated solid dosage form comprising an inner coating located between a core containing a pharmaceutically active ingredient and an outer enteric coating.” Final Act. 3. The Examiner finds that Patel discloses that the inner coating comprises a partially neutralized anionic polymer material and contains at least one water soluble inorganic salt such as sodium chloride. Id. The Examiner finds that Patel discloses an outer layer comprising an anionic polymer material, which is not neutralized. Id. The Examiner concludes: Because Patel et al. teach alkali metal, alkaline earth metal cations, and the anion of the inorganic salt is selected from the group consisting of chloride and borate anions are functionally equivalent agents for providing a latex of the first coating, it would have been obvious to a person of ordinary skill in the art to substitute some of the ammonia, with sodium chloride to provide a latex for the purpose of coating the drug particles. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Furthermore, mixtures of neutralizing agents are expressly suggested (para. [0031]). Id. at 3–4. Findings of Fact We adopt the Examiner’s findings as our own, including with regard to the scope and content of, and motivation to modify or combine, the prior Appeal 2018-004419 Application 13/603,984 6 art. The following findings are included for emphasis and reference purposes. FF1. Patel discloses a pharmaceutical composition comprising an active ingredient core, a first coating applied to the surface of the core, which is insoluble in gastric and intestinal juices but soluble in colonic juice, and a second coating applied to the surface of the first coating. Patel Abstract. FF2. Patel teaches that the first coating is preferably an anionic polymer such as a polymer of methacrylic acid and methacrylic acid methyl ester. More preferably, the polymer of methacrylic acid and methacrylic acid methyl ester has a ratio of free carboxyl groups to ester groups of about 1:2 or 1:1. A preferred anionic polymer is available under the trademark “Eudragit® S 100” from Rohm Pharma. Patel ¶ 30. FF3. Patel teaches In one embodiment of the invention, the first coating additionally comprises an alkali agent. While not wishing to be bound by any particular theory, the present inventors believe that the alkali agent form a latex dispersion with the first coating polymer which maintains homogeneity of a first coating dispersion. Suitable alkali agents include, but are not limited to, the inorganic salts of metals of Groups I and II of the Periodic Table. Thus, salts of alkali and alkaline earth metals are operable. The anionic portion of the salt may be any which does not deleteriously affect the adhesive properties of the first coating. Thus, borates, silicates and carbonates are contemplated. Specific examples of alkali agents include ammonia, ammonium hydroxide, sodium chloride, calcium Appeal 2018-004419 Application 13/603,984 7 hydroxide, lithium hydroxide, magnesium hydroxide, potassium hydroxide, barium hydroxide, sodium hydroxide, calcium carbonate, lithium carbonate, magnesium carbonate, potassium carbonate, sodium carbonate, calcium hydrogencarbonate, lithium hydrogencarbonate, magnesium hydrogencarbonate, potassium hydrogencarbonate and sodium hydrogencarbonate. A preferred alkali agent is ammonium hydroxide. A mixture of alkali agents may also be used. Id. ¶ 31 (emphasis added). FF4. Patel teaches that the second coating may comprises the same or a different polymer than the first coating, specifically the coating may comprise methacrylates or cellulose based polymers. Id. ¶ 40. FF5. Rudolph teaches that EUDRAGIT S can be neutralized by the addition of ammonia. Rudolph, 184–85. FF6. Oshlack discloses a stable controlled release formulation having a coating applied to an active agent substrate such as a therapeutic agent. Oshlack Abstract. FF7. Oshlack teaches that the coating may comprise a hydrophobic polymer such as acrylic polymers. Id. col. 9, ll. 1–65. FF8. Oshlack teaches that the release of the active agent can be controlled by the inclusion of pore-formers into the coating material. Id. col. 10, ll. 36–44. FF9. Oshlack teaches that sodium chloride can be used as a pore- former. Id. col. 10, ll, 61–62. Appeal 2018-004419 Application 13/603,984 8 Principles of Law [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992 Analysis Appellants have presented separate arguments with respect to claims 63 and 76, which we address below. The remaining claims subject to this rejection, 65, 66, 68, 71, 72, 77–80, and 82–84 fall with either claim 63 or 76. 37 C.F.R. § 41.37(c)(1)(iv). Claim 63 We agree with the Examiner that the subject matter of claim 63 would have been obvious over Patel as evidenced by Rudolph combined with ACRYL-EZE and Oshlack. Patel teaches a pharmaceutical composition having a core surrounded by two coatings. FF1. The polymer of the first coating may comprise an anionic polymer. FF2. The first coating may contain an alkali agent such as ammonia and sodium chloride or a mixture of alkali agents. FF3. Ammonia will neutralize an anionic polymer resulting in a partially neutralized polymer. FF5. Patel teaches that the polymer of the second coating may be the same or different than the polymer used in the first coating. FF4. Patel teaches that the alkali agents act to help improve the homogeneity of the polymer dispersion used in the first coating. FF3. We agree with the Examiner that one skilled in the art would have been Appeal 2018-004419 Application 13/603,984 9 motivated to use both ammonia and sodium chloride as Patel specifically teaches the use of a mixture of alkali agents and teaches that both compound can be used for the same purpose. Final Act. 3–4. Appellants contend that unlike the other alkali agents recited in Patel, sodium chloride is insufficiently basic to at least neutralize the anionic polymers used in Patel. Appeal Br. 7. Appellants contend that the use of sodium chloride would not result in the inner coating containing a partially neutralized polymer and would not produce a homogeneous dispersion. Id. at 8. Appellants also contend that sodium chloride is not functionally equivalent to the other alkali agents listed in Patel in that sodium chloride is not basic and cannot neutralize the anionic polymer. Id. at 9. We have considered Appellants’ arguments and are not persuaded. Although we agree with Appellants that sodium chloride may not neutralize an anionic polymer, Patel does not teach that use of sodium chloride to neutralize the anionic polymer but teaches that it may aid in maintaining the homogeneity of the polymer dispersion. FF3; Ans. 8–9. Although Appellants contend that, the statement in Patel is based on speculation and conjecture, Appellants offer no evidence that this statement is untrue and that it would not lead one skilled in the art to use sodium chloride to help maintain the stability of the dispersion. Appeal Br. 11. “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). As discussed above Patel teaches that a mixture of alkali agents can be used in the first coating and that both sodium chloride and ammonia can be used as alkali agents. FF3. Rudolph teaches that the addition of ammonia to anionic polymers at least partially neutralizes the polymer. FF4. Thus, a Appeal 2018-004419 Application 13/603,984 10 mixture of both ammonia and sodium chloride would result in a partially neutralized polymer containing sodium chloride. Final Act. 3–4. Appellants next contend that Patel teaches away from the use of sodium chloride in the first coating. Appeal Br. 10. Appellants contend that Oshlack teaches the use of sodium chloride as a pore-former. Id. Appellants contend that the formation of pores or channels in the first coating would be contrary to the teachings of Patel. Id. Appellants argue that Patel teaches that the damage to the first coating should be avoided to prevent partial coating of the active ingredient leading to unwanted variability of release of the active ingredient. Id. Appellants contend that this would discourage one skilled in the art from using sodium chloride in the first coating, as it would create partially coated active ingredient. Id. We have considered Appellants argument and are not persuaded. Paragraph 44 of Patel refers to ensuring that a sufficient amount of the second coating is applied to prevent damage to the first coating, “especially during compression of the coated particles to form tablets.” Patel ¶ 44. Thus, Patel is referring to damage, which might occur during manufacture, not pores that may appear during normal use of the compositions. Based on the explicit teaching in Patel, that sodium chloride can be used in the first coating and any reference to damage, is directed to damage that may occur during formation of a tablet, we are not persuaded that Patel and Oshlack teach away from the claimed composition. Appellants contend that there is evidence of unexpected results sufficient to rebut the Examiner’s finding of obviousness. Appeal Br. 13. Appellants contend that the Specifications shows that a solid dosage form with an outer coating of Eudragit®L30D- 55 and an inner coating of Eudragit®L30D-55, wherein 20% Appeal 2018-004419 Application 13/603,984 11 NaCl is added to the inner coating of Eudragit®L 30D-55 at pH 5.6, provides unexpectedly superior release delay over a solid dosage form with an outer coating and inner coating of Eudragit®L30D-55 wherein 10% Na citrate is added to the inner coating of Eudragit®L 30D-55 at pH 6.0. Thus, Applicant’s Table 13 fairly compares the closest prior art, as indicated by Oshlack. Id. at 13–14 citing to Spec, 62 and Table 13. Appellants contend the Examiner’s finding that the examples are not commensurate with the scope of the invention is in error. Id. at 14–15. Appellants point to the teachings of table 6 where it shows that the degree of neutralization affects the release rate of the active ingredient and tables 11 and 13 show that the presence of sodium chloride affects the release rate as well. Id. Appellants contend that taken together the examples are commensurate with the scope of the claims. We are not persuaded by Appellants’ arguments. Appellants have provided insufficient evidence that the reported results are unexpected. “[I]t is well settled that unexpected results must be established by factual evidence. ‘Mere argument or conclusory statements in the specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)). The Specification is silent on the matter and Appellants have not offered a declaration to support their contention that the results were unexpected. See Spec. 44–48, Appeal Br. 13–14. The only statements that the results are unexpected are only attorney argument. In addition, we agree with the Examiner that the evidence of record is not commensurate with the scope of the claims. The data cited by Appellants relates to compositions where the first coating is partially Appeal 2018-004419 Application 13/603,984 12 neutralized or where the inner coating contains sodium chloride. Spec. Tables 6 and 11. Appellants have not pointed to any example reporting the use of a composition where the polymer of the coating is partially neutralized and contains a water soluble inorganic salt as require by the claims. Thus the data relied upon by Appellants is not commensurate with the scope of the claims. “The evidence presented to rebut a prima facie case of obviousness must be commensurate in scope with the claims to which it pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). Claim 76 Appellants contend that the references do not teach the limitation of claim 76 calling for the polymer in the second coating to be the same as the polymer in the first coating. Appeal Br. 20. Appellants contend that to meet this limitation, the polymer must not just be the same type of polymer but that the identical polymer must be used in both the first and second coatings. Id. Appellants contend that while Patel speaks of using copolymer of acrylic acid and methacrylate, the actual polymer used, have different ratios of acrylate and methacrylate and are not the same polymer. Id. Appellants also contend that there is nothing in Patel that would motivate one skilled in the art to use the same anionic polymer in both the first and second coatings. Id. at 21. Appellants’ argument hinges on a narrow definition of the term “same anionic polymer material.” Appellants contend that this limitation requires complete identity of the materials, not merely that the polymers are of the same type. See Appeal Br. 20. We do not construe the term so narrowly. “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). In the present case, the Specification Appeal 2018-004419 Application 13/603,984 13 teaches that the first and second coating may comprise an anionic polymer material selected from the group consisting of “polymethacrylates, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate (HPMC-AS), cellulose acetate trimellitate or shellac.” Spec. ¶¶ 39 and 41. Claim 77, which depends from claim 76 reads The solid dosage form according to claim 76, wherein the anionic polymeric material of the inner and/or outer coating is selected from the group consisting of polymethacrylates, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate (HPMC-AS), cellulose acetate trimellitate, and shellac. Appeal Br. 35 (Claims App.). Given the teachings in the Specification and the claims the broadest reasonable interpretation of the claims is that the term “same anionic polymer material” refers to the same type of polymer material and does not require exactly the same material in both. Applying this construction, we agree with the Examiner that Patel teaches that the anionic polymer material in the first and second coating can be the same polymer. Final Act. 4, Ans. 16–17. Patel’s use of the same types of polymers in the examples cited by Appellants would have motivated one skilled in the art to use that type of polymer. Conclusion of Law We conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 63 and 76 would have been obvious over Patel as evidenced by Rudolph combined with ACRYL-EZE and Oshlack. Appeal 2018-004419 Application 13/603,984 14 Claims 65, 66, 68, 71, 72, 77–80, 82–84, and 86 have not been argued separately and therefore fall with claim 63 or 76. 37 C.F.R. § 41.37(c)(1)(iv). PATELCOMBINED WITH ACRYL-EZE, OSHLACK AND PETEREIT Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 63, 65, 66, 68–72, and 76–87 would have been obvious over Patel combined with ACRYL-EZE, Oshlack and Petereit. The Examiner reiterates the findings recited above. Final Act. 13. The Examiner finds that Patel does not teach a composition where the anionic polymer in the outer layer is partially neutralized. Id. The Examiner finds that this limitation is taught by Petereit. Id. The Examiner finds that Petereit teaches the use of a polymethacrylate coating for pharmaceutical compositions. Id. The Examiner finds that Petereit teaches that the coating can be partially neutralized. Id. The Examiner finds that Petereit teaches that the composition can have an additional layer between the coating and the active ingredient where the additional layer can be partially or completely neutralized. Id. at 14. The Examiner concludes it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the composition of Ex. 5 of Patel et al., having a mixture of ammonia and sodium chloride by adding the partially neutralized copolymer Ex. 14 of Petereit et al. to the ACRYL- EZE coating material to increase the shear stability of the composition and to avoid dissolution at 1.2. The skilled artisan would have had a reasonable expectation of success because Petereit et al. suggest controlling drug release by mixing the Appeal 2018-004419 Application 13/603,984 15 polymers of the invention with EUDRAGIT L 100-55, Petereit et al. teach the polymers are preferably applied by spraying aqueous dispersions, and because the polymers of Petereit et al. are intended to permit colonic delivery of active agents, which is the object of the delivery systems of Patel et al. The modification is reasonably expected to result in the outer enteric coating having a degree of neutralization that is less than the 15% neutralized carboxyl groups of the inner layer polymeric material because the mixture of the copolymers cannot have a degree of neutralization that is higher than 5%. Id. at 15. Appellants contend that Petereit does not teach or suggest a composition having an inner coating containing a water soluble inorganic salt. Appeal Br. 23. Appellants also contend that Petereit does not teach or suggest that the outer coating be partially neutralized to a lesser extent than the inner coating as required by claims 70, 81, 86, and 87. Id. at 23 and 27– 30. Analysis We begin by noting that while the rejection lists claims 63, 65, 66, 68–72, and 76–87, only claims 70, 81, 86, and 87 require that polymer of the outer coating be partially neutralized to a lesser extent than the inner coating. See, e.g., Appeal Br. 34 (Claims App.). Independent claims 63 and 76 call for the polymer of the outer coating to not be neutralized or partially neutralized. Id. at 33 and 35. Patel teaches that use of an outer coating where the polymer is not neutralized satisfy the limitation of claims 63 and 76. See Patel ¶ 31 (Alkali agent only added to the inner coating). We have considered the positions advanced by the Examiner and Appellants and find that Appellants have the better position. While Petereit teaches that both the inner and outer coatings may be partially neutralized, Appeal 2018-004419 Application 13/603,984 16 we find nothing in the references that teaches or suggests that the outer coating should be partially neutralized to a lesser degree than the inner coating. Petereit ¶¶ 43 and 90–91. The Examiner points to the teaching in Petereit that the outer coating can be partially neutralized whereas the inner coating can be partially or fully neutralized and argues that this would lead one skilled in the art to develop a composition where the outer coating is less neutralized than the inner coating. Ans. 18. We are not persuaded. We do not interpret the cited passages of Petereit as suggesting that the outer coating should be less neutralized than the inner coating. Conclusion of Law A preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 63 and 76 would have been obvious over Patel combined with ACRYL-EZE, Oshlack and Petereit. A preponderance of the evidence does not support the Examiner’s conclusion that the subject matter of claims 70, 81, 86, and 87 would have been obvious over Patel combined with ACRYL-EZE, Oshlack and Petereit. Claims 65, 66, 68, 69, 71, 72, 77–80, and 82–85 have not been argued separately and therefore fall with claims 63 and 76. 37 C.F.R. § 41.37(c)(1)(iv). PATEL COMBINED WITH ACRYL-EZE, OSHLACK AND DEGUSSA Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of the claims would have been obvious over Patel combined with ACRYL- EZE, Oshlack and Degussa. Appeal 2018-004419 Application 13/603,984 17 The Examiner reiterates the findings made with respect to the teachings of Patel, ACRYL-EZE and Oshlack. Final Act. 20. The Examiner finds that Patel does not teach the weight gain limitation recited in claims 71 and 82. Id. The Examiner finds that Degussa teaches the recited weight gain. Id. The Examiner concludes [I]t would have been obvious to a person of ordinary skill in the art to follow the teachings of Degussa for coating the pellets with EUDRAGIT S and the tablet comprising the pellets with EUDRAGIT L 100-55. Because the range in Degussa overlaps the instantly claimed range, and the amount was known to influence the mechanical stability or solubility of the dosage form, a prima facie case of obviousness exists. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257 (CCPA 1976). Id. Appellants argue that for the reasons stated above, claims 63 and 76 are patentable over the references. Appeal Br. 26. With respect to claims 71 and 82, Appellants contend that while Degussa teaches overlapping weight gain ranges for Eudragit L 100 and S 100, Degussa is not directed to a multilayer dosage form with at least one partially neutralized polymer nor does Degussa teach the inclusion of a water soluble inorganic salt. Id. at 27. Appellants contend that it is mere speculation that the teachings of Degussa are applicable to the claimed dosage form. Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established that the subject matter of the claims would have been obvious to one of ordinary Appeal 2018-004419 Application 13/603,984 18 skill in the art at the time the invention was made over Patel combined with ACRYL-EZE, Oshlack and Degussa. Appellants have not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellants in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. We address Appellants’ arguments below. With respect to claims 63 and 76, as discussed above, we agree with the Examiner that the subject matter of the claims would have been obvious over Patel combined with ACRYL-EZE, Oshlack. Degussa is not used to address any of the limitations in these claims. See Final Act. 19–21. Turning to claims 71 and 82, the rejection is based not on Degussa alone but on the combination of Degussa with Patel, ACRYL-EZE, and Oshlack. Final Act. 19. Degussa is used only to teach the weight gain achieved by application of the polymers taught in Patel. Id. at 20. Given the teaching in Patel to use the polymers discussed in Degussa and the relevance of Patel to the present claims, we do not agree with Appellants that the applicability of Degussa is based in mere speculation. Conclusion of Law We conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 63, 71, 76, and 82 would have been obvious over Patel combined with ACRYL-EZE, Oshlack and Degussa. Claims 65, 66, 68, 69, 72, 77–80 and 83–85 have not been argued separately and therefore fall with claims 23 and 76. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2018-004419 Application 13/603,984 19 SUMMARY We affirm the rejection of claims 63, 65, 66, 68, 69, 71, 72, 76–80, and 82–85 under 35 U.S.C. § 103(a). We reverse the rejection of claims 70, 81, 86, and 87 under 35 U.S.C. § 103(a). 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 Copy with citationCopy as parenthetical citation