Ex Parte Andjelic et alDownload PDFPatent Trials and Appeals BoardMay 23, 201914176232 - (D) (P.T.A.B. May. 23, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/176,232 02/10/2014 27777 7590 05/28/2019 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 FIRST NAMED INVENTOR Sasa Andjelic 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 ATTORNEY DOCKET NO. CONFIRMATION NO. ETH5660USDIV1 2343 EXAMINER BABSON, NICOLE PLOURDE ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 05/28/2019 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pairjnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SASA ANDJELIC and DENNIS D. JAMIOLKOWSKI 1 Appeal2018-007617 Application 14/176,232 Technology Center 1600 Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and ELIZABETH A. LA VIER, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to semi-crystalline segmented copolymer having an A-B-A block configuration made by melt polymerization. The Examiner rejected the claims as obvious under 35 U.S.C. § 103(a). Pursuant to 35 U.S.C. § 134(a), Appellants appeal the Examiner's determination that the claims are unpatentable. We have jurisdiction under 35 U.S.C. § 6(b). The Examiner's decision is affirmed. 1 The Appeal Brief ("Br."; entered Jan.29.2018) lists Ethicon, Inc. as the real party in interest. Appeal2018-007617 Application 14/176,232 STATEMENT OF THE CASE This appeal is related to Appeal No. 2018-001382 of Application 13/417,810. A decision in that appeal was entered Jan. 31, 2019. The application was abandoned April 26, 2019. The Examiner finally rejected claims 23, 24, and 26-31 under pre- AIA 35 U.S.C. § 103(a) as obvious in view ofVenkatraman et al. (WO 2011/059408 Al, published May 19, 2011) ("Venkatraman"), Baimark et al. (Synthesis and characterization of poly(L-lactide-co-E-caprolactone) (B)- poly(L-lactide) (A) ABA block copolymers, Polym. Adv. Technol., 16: 332- 337, 2005) ("Baimark"), and Verser et al. (U.S. Pat. No. 5,633,342, issued May 27, 1997) ("Verser"). Final Act. 3. Claim 23, the only independent claim on appeal, is reproduced below: 23. A bioabsorbable semi-crystalline segmented copolymer having an A-B-A block configuration made by melt polymerization comprising the reaction product of product of: (a) a fully amorphous pre-polymer formed from polymerizing lactide monomer, and epsilon-caprolactone monomer in the presence of an initiator, wherein the mole ratio of lactide to epsilon-caprolactone in the prepolymer is between about 45:55 to about 30:70 forming a center B block; and (b) lactide monomer forming end blocks A, wherein the mole ratio of the lactide to epsilon-caprolactone in said copolymer is between about 72:28 to about 76:24, wherein the center B block is fully amorphous. DISCUSSION Claim 23 is directed to a semi-crystalline copolymer of an A-B-A block configuration made by melt polymerization. The polymer is a reaction product of: 2 Appeal2018-007617 Application 14/176,232 (a)"[ A] fully amorphous prepolymer" which is formed from "lactide monomer" and "epsilon-caprolactone monomer" in the ratio between about 45:55 to about 30:70. The claim recites that the "polymerizing" of these two monomers is "forming a center B block." We, therefore, interpret the "fully amorphous prepolymer" to be the center B block of the A-B-A polymer. The center block B is recited by the claim to be "fully amorphous." (b) Lactide monomer forming end blocks A. The claim recites that mole ratio of the lactide to epsilon-caprolactone in the copolymer is between about 72:28 to about 76:24. The Examiner found that V enkatraman describes an A-B-A copolymer with the same structure as claimed, but not produced by melt polymerization. Final Act. 3. The Examiner also found that V enkatraman also discloses that the B block is amorphous and the ratio of monomers overlaps with the claimed ratio. Id. The Examiner found that V enkatraman describes a mole ratio of lactide to epsilon-caprolactone in the copolymer "which is slightly below the claimed range," but found that the claimed range would have been obvious based on the teachings in Verser and Baimark, which describe overlapping ranges. Final Act. 4-5. The Examiner found that V enkatraman does not describe making the copolymer by "melt polymerization" as required by the claims. Final Act. 4. To meet this deficiency, the Examiner cited the disclosure in Verser of melt polymerization. Final Act. 4-5. The Examiner found that Verser describes making a copolymer of lactide and epsilon-caprolactone by melt polymerization, the same monomers as claimed. Id. at 5. The Examiner 3 Appeal2018-007617 Application 14/176,232 also found that Verser teaches "that the pre-copolymer has 'reduced crystallinity' and is exemplified as having no melting peak, which would indicate an amorphous pre-copolymer (e.g. column 4, lines 55-63; Example 50)." Id. The Examiner also found that Baimark teaches "ABA block copolymers of lactide and E-caprolactone in a mole ratio of 75:25 (e.g. abstract and Table I)," the same ratio which is claimed. The Examiner determined it would have been obvious to have used melt polymerization, as required by the claim, to make Venkatraman' s polymer: One of ordinary skill in the art would have been motivated to produce the polymers via melt polymerization, as in Verser et al., as Verser et al. teach that the material costs for melt polymerization are reduced relative to those for solution polymerization (as in Venkatraman) and when using melt polymerization techniques the amount of by-products and wastes produced are typically minimized, less equipment is needed because there is no solvent to be removed from the synthesized block copolymers and treated or otherwise handled and as a result, melt polymerization generates less volatile organics than solution polymerization, making melt polymerization a technically less complicated and more environmentally sound process than solution polymerization). Final Act. 6. The Examiner further found that Baimark describes copolymers of lactide and epsilon-caprolactone and that such copolymers are used as absorbable monofilament sutures. Final Act. 6. Appellants did not dispute the Examiner's finding that V enkatraman describes a copolymer of the ABA structure comprised of the lactide and epsilon-caprolactone monomers. Br. 12. Consequently, we consider this 4 Appeal2018-007617 Application 14/176,232 issued to be waived and have not addressed it further in this Decision on Appeal. Appellants argue that the copolymers of V enkatraman are made by a solution polymerization process and that it "would not be possible to manufacture Applicants' novel copolymers using the solution polymerization process disclosed and required by Venkatraman, et al." Br. 11. Appellants contend that "it would be impossible to obtain Applicants' novel block copolymers having a fully amorphous center block B and having a unique morphology, and it would be impossible to obtain Applicants' fully amorphous prepolymers." Id. As evidence of this, Appellants provided a declaration under 37 C.F.R. § 1.132 by Sasa Andjelic, Ph.D., a co-inventor of the claimed invention which was submitted on July 29, 2014 ("1st Andjelic Deel."). Dr. Andjelic stated in his declaration that bioabsorbable copolymers, having a composition similar to the polymers disclosed in his patent application, which are made by a solution polymerization process as disclosed in V enkatraman, would have a semi-crystalline "B" segment of the lactide-epsilon-caprolactone copolymer because "the transesterification reactions that would normally occur in high temperature melt polymerizations would be very much reduced (minimized) in the low temperature, solvent polymerization" of Venkatraman. 1st Andjelic Deel. ,i 5. Dr. Andjelic explained that the "transesterification reactions scramble the sequence distribution making it difficult to retain the chain symmetry to allow crystallization." Id. Dr. Andjelic provided evidence to support his opinion, citing the Grijpma publication as showing that a lactide and epsilon-caprolactone copolymer formed a semi-crystalline structure when 5 Appeal2018-007617 Application 14/176,232 prepared by solution polymerization as in the V enkatraman process. Id. Dr. Andjelic also cited a publication by den Dunnen to further support his opinion. Id. Dr. Andjelic stated that the molecular weight distribution of the claimed polymers distinguishes them from Venkatraman. 1st Andjelic Deel. ,i 5 (p. 3). Dr. Andjelic stated the polymers made by the "patent application," although not reported in the application, had a molecular weight distributions which "were generally about half, or a little less" than those ofVenkatraman. Id. at ,i 5 (pp. 4-5). The referenced data were not shown in his declaration. Dr. Andjelic also provided a second declaration executed July 19, 2016 in which he described experiments "to determine whether the solvent polymerization process of V enkatraman et al. would yield block copolymers having a fully amorphous center block." 2nd Andjelic Deel. ,i 6. Based on the test results of the experiments described in that declaration, Dr. Andjelic reported Id. copolymers having the chemical composition of the copolymers of the present invention that were made using the solvent process of V enkatraman et al. had a semicrystalline middle block (prepolymer) structure in contrast to the copolymers of the present invention which have a fully amorphous middle block and which are made using fully amorphous prepolymer. Dr. Andjelic also stated that it is his opinion that Baimark does not disclose an amorphous prepolymer as claimed, and that such copolymers would by crystalline. 2nd Andjelic Deel. ,i 7. Dr. Andjelic explained technically why Baimark's process utilizing solid state polymerization would result in crystallization in contrast to the melt polymerization in the 6 Appeal2018-007617 Application 14/176,232 claims. Id. While Baimark concluded their polymers were amorphous, Dr. Andjelic stated, "their own data suggest that all of their prepolymers are, in fact, semicrystalline." Id. (para. 7). We have considered the 1st and 2nd Andjelic declarations, but are not persuaded that they demonstrate an error in the Examiner's rejection. Dr. Andjelic's declarations explain why the process described in Venkatraman and Baimark would not result in the claimed amorphous copolymer. However, the Examiner specifically cited Verser for teaching the melt polymerization process to produce the claimed copolymer with the amorphous center block B. The Examiner did not rely on the processes described in V enkatraman and Baimark to make the claimed copolymer. Rather, these publications were cited for their description of copolymers within the scope of the claim and with the claimed ratio of monomers. Final Act. 3, 5. Thus, while certain process conditions in Venkatraman and Baimark might produce crystalline polymers, this argument is unavailing because the rejection was based on Verser's process, not on those of V enkatraman and Baimark. Nonetheless, Venkatraman describes making its B segment amorphous. Venkatraman ,-J,-J 23, 42. Verser, as found by the Examiner, "further teach that the pre-copolymer has 'reduced crystallinity' and is exemplified as having no melting peak, which would indicate an amorphous pre-copolymer (e.g. column 4, lines 55-63; Example 50)." Final Act. 5. As found by the Examiner, the skilled worker reading Venkatraman's disclosure of making the B segment amorphous would have had reason to use Verser' s melt polymerization process to make a polymer with reduced crystallinity and amorphous. Final Act. 6. 7 Appeal2018-007617 Application 14/176,232 Appellants also argue that Verser teaches that its polymers "are environmentally degradable for use in plastic bags and packaging films having accelerated degradation after disposal" and "distinguish their polymers from biodegradable plastics that are implanted in the body and teach away from bioabsorbable implantable polymers (See col. 3, lines 20- 30)." Br. 7. While we agree that Verser distinguishes its polymers from ones utilized in the body, Verser specifically states this is a preferred embodiment. ("Preferably, the environmentally degradable block copolymers of the present invention can be distinguishable from biodegradable plastics which are used in the body ... "). Verser col. 3, 11. 20-22. Thus, Verser is not limited to such embodiments. Verser distinguishes its own preferred copolymers from plastics used in the body, but Verser characterizes its polymers as degradable, which is the same property as those of Venkatraman (Abstract). The properties overlap, providing an additional reason why one of ordinary skill in the art would looked to Verser for guidance on how to make Venkatraman's copolymers. Moreover, the Examiner did not rely on Verser for disclosing the claimed copolymer structure, rather the Examiner cited V enkatraman for describing the claimed bioabsorbable copolymer structure. See Venkatraman Abstract, ,-J,-J 2-4, 6, and 44 ( describing the polymers as "biodegradable"). Appellants did not dispute the Examiner's finding regarding Venkatraman's description of a copolymer comprising the claimed epsilon-caprolactone and lactide with the recited A-B-A structure. Baimark also describes a copolymer of lactide and epsilon-caprolactone as biodegradable and biocompatible materials, a finding not disputed by 8 Appeal2018-007617 Application 14/176,232 Appellants. Baimark § 332. Appellants did not establish that one of ordinary skill in the art would have been dissuaded from utilizing melt polymerization, as taught by Verser, for making the bioabsorbable copolymers as required by all the rejected claims. Molar ratio Appellants contend that the overall mole ratio of lactide to epsilon- caprolactone described in the claims is not disclosed in either V enkatraman or Baimark. Br. 13. This argument is not persuasive. Claim 23 recites "the mole ratio of the lactide to epsilon-caprolactone in said copolymer is between about 72:28 to about 76:24." The Examiner found that Venkatraman teaches "the overall mole ratio of polymerized lactide to polymerized epsilon-caprolactone is between about 25:75 to about 70:30 (as calculated from paragraph 0028), which is slightly below the claimed range of about 72:78 to 76:24." Final Act. 3-4. To address this deficiency, the Examiner found that Baimark describes a mole ratio of 75:25 of lactide to epsilon-caprolactone which falls within the scope of the claim. Id. at 5. The Examiner found that one of ordinary skill in the art would have had reason to use Baimark's ratio in Venkatraman because both cited publications describe making suture and monofilament sutures from "a substantially similar block copolymer." Id. at 6. Appellants did not identify a deficiency in this argument and we find none. The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims ... in such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. 9 Appeal2018-007617 Application 14/176,232 In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Appellants have not provided evidence that the claimed ratio of lactide to epsilon-caprolactone is critical, achieves unexpected results, or has different properties that the broader ranges disclosed in V enkatraman. Appellants state: "None of the references in the combination disclose or suggest the criticality of utilizing a fully amorphous prepolymer to form the fully amorphous middle B block of Applicants' copolymers." Br. 13. Appellants state: "None of the references provide for Applicants' novel copolymers having a fully amorphous center block." Id. As already discussed above, V enkatraman discloses a B block which is amorphous. V enkatraman teaches that "B is the middle segment of the triblock elastomer A-B-A and may be called the 'soft' segment. In one embodiment this segment is made to be amorphous." V enkatraman ,i 23. The critical feature asserted by Appellants is therefore described by V enkatraman. Appellants state: "None of the references recognize the criticality of utilizing melt polymerization processes to obtain Applicants' novel copolymers." Br. 13. Verser teaches melt polymerization to make lactide and E- caprolactone copolymers. See, e.g., Verser 3:40-55; 6:11-18. Appellants do not dispute this. Thus, melt polymerization was used by Verser to make a copolymer with the same monomers as claimed. Appellants did not explain the criticality of this step when it is used by Verser to make a polymer of the same constituent monomers which are claimed. 10 Appeal2018-007617 Application 14/176,232 Reasonable expectation of success Appellants contend "that a person skilled in this art would have no reasonable expectation of success in obtaining Applicants' novel fibers and polymers by combining the references cited by the Examiner." Br. 13. Appellants also contend that the "novel polymers and fibers surprisingly and unexpectedly provide" certain advantages that "derive from the morphology of Applicants' novel block copolymers having a fully amorphous center block formed from a fully amorphous prepolymer." Id. at 10. First, Appellants have not provided persuasive evidence or explanation as to why it would not have been expected that Verser' s process could be used to produce a polymer of V enkatraman. Appellants have simply made conclusory statements, without identifying a specific reason as to why melt polymerization as described in Verser would not have been reasonably expected to successfully produce V enkatraman' s polymer made the same monomeric constituents. As explained above, the declarations by Dr. Andjelic address the process described in Verser and Baimark, but not the melt polymerization process of Verser, which formed the basis of the obviousness rejection of the claims. Second, Appellants have not provide adequate evidence of unexpected results. A showing of "unexpected results" can be used to demonstrate the non-obviousness of the claimed invention. In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). Id. One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of 'unexpected results,' i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected. 11 Appeal2018-007617 Application 14/176,232 Appellants state in the Appeal Brief that the claimed polymers have surprisingly and unexpected advantages, but provided no extrinsic, objective evidence that such properties are possessed by the claimed polymers and not by other polymers, namely, an adequate "showing" under Soni was not made. In addition to this, to establish unexpected results, the claimed subject matter must be compared with the closest prior art. Soni, 54 F.3d at 750; Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (A showing of "new and unexpected results" must be "relative to the prior art."); In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art."). Appellants did not provide a comparison with the closest prior art to establish that the properties asserted to be surprising and unexpected were not possessed by the cited prior art polymers. Unexpected results also must be "commensurate in scope with the degree of protection sought by the claimed subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). Appellants have not explained or provided evidence that the surprising and unexpected results are for the full scope of each rejected independent and dependent claim. Summary For the foregoing reasons, the obviousness rejection of claim 23 is affirmed. Claims 24 and 26-31 were not argued separately and fall with claim 60. See 37 C.F.R. § 41.37(c)(l)(iv). 12 Appeal2018-007617 Application 14/176,232 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv). AFFIRMED 13 Copy with citationCopy as parenthetical citation