CTNF 18/552,360 CTNF 88592 DETAILED ACTION 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. This application is a national stage entry under 35 U.S.C. §371 of International Application No. PCT/JP2022/006067 filed 2/16/2022. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. §119(a)-(d) by Application No. JP 2021-058742 filed 3/30/2021, which papers have been placed of record in the file. Claims 1-9 are pending. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-37 AIA Claim s 1, 3, 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 2, 5, 8-9 of copending Application No. 18/552,349 in view of Buchholz et al. (US 2007/0014848) . This is a provisional nonstatutory double patenting rejection. Regarding claim 1: An amendment to incorporate claims 2 and 5 into claim 1 of copending 18/552,349 arrives at claim 1 of the present invention. While copending 18/552,349 claims 1, 2, and 5 disclose a molded body including additional components, e.g. a plasticizer, claims 1, 2, and 5 of copending 18/552,349 arrives at claim 1 of the present invention in an obviouness type manner. While the molecular weight of chain B is not claimed, Buchholz et al. (US 2007/0014848) discloses the chain B include PEG having a weight average molecular weight of 1500 or greater and 25000 or less in the working examples. One skilled in the art would have been motivated to have selected the chain B of Buchholz for improved properties and can be produced simply on an industrial scale ([0011] Buchholz). Regarding claims 3, 9: The reaction of the polyester and glycol produces an ester bond in 18/552,349. A molded article is claimed. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the weight average molecular weight of the glycolic acid copolymer composition is 15000 or greater. However, it would not be clear how a composition of a polymer and an anhydride can have a molecular weight. Specifically, a composition comprises more than one component, and hence a composition would have two components with two different molecular weights. Claims 2-9 are subsumed by this rejection because of their dependence. Claim 2 recites parenthesis, although it would not be clear why parenthesis are recited. The use of parenthesis renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction and/or clarification is required. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-21-aia AIA Claim s 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Buchholz et al. (US 2007/0014848) in view of Masaki et al. (US 2015/0051119) . Regarding claim 1 : Buchholz is directed to a glycolic acid copolymer composition comprising a glycolic acid copolymer. Specifically, the copolymer includes an absorbable polymer including polyglycolide ([0007]-[0008]) as a straight macromolecular chains A containing a repeating unit derived from glycolic acid. The polyglycolic acid is chemically bonded to a macromolecular chain B different than the macromolecular chains A. The macromolecular chain B is derived from a macromolecular compound having a weight average molecular weight of 1500 or greater and 250000 or less in the working examples. Specific macromolecular chains B include PEG 6000 utilized in the working examples, which is substantially identical to PEG 7500 utilized in the present invention having a Tg of -67 ˚C, and therefore one skilled in the art would conclude PEG 6000 has a Tg of lower than 45 ˚C. A carboxylic acid anhydride is not mentioned. Masaki is directed to a biodegradable polymer comprising a glycolic acid copolymer composition comprising a glycolic acid and a carboxylic acid anhydride. The carboxylic acid anhydride is added as a degradation accelerator. One skilled in the art would have been motivated to have included a carboxylic acid anhydride degradation accelerator since it results in a polyester resin composition with excellent degradability and excellent storing properties ([0056] Masaki). This is relevant since Buchholz is directed to degradable materials ([0010] Buchholz). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have included a carboxylic acid degradation accelerator. The weight average molecular weight of the glycolic acid composition is not mentioned. Masaki teaches the molecular weight of the glycolic acid is preferably 20,000 to 600,000. One skilled in the art would have been motivated to have selected a polyglycolic acid having a weight average molecular weight taught in Masaki to produce a molded article with sufficient strength and melt viscosity ([0025] Masaki). Selection of a glycolic acid having a weight average molecular weight of 20,000 to 600,000 would result in a glycolic acid copolymer composition having a weight average molecular weight of at least 150,000. Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have selected polyglycolic acid having a weight average molecular weight within the scope of claim 1. Regarding claim 2 : The copolymer includes an ABA type block copolymer ([0011] Buchholz). Regarding claim 3 : The macromolecular chains A and B are bonded by an ester bond since the ABA block copolymer is a polyetherester. Regarding claim 4 : The macromolecular chain B is derived from a macromolecular compound having a weight average molecular weight of 2500 or greater and 50000 or less in the working examples. Specific macromolecular chains B include PEG 6000 utilized in the working examples. The amount of macromolecular block B is 0.01-20 wt% in the copolymer ([0051] Buchholz) (equivalent to 0.5 or greater and 20 or less with respect to 100 total of the macromolecular chain A in mass ratio. Regarding claim 5 : The macromolecular chain B is derived from a macromolecular compound having a weight average molecular weight of 2500 or greater and 50000 or less in the working examples. Specific macromolecular chains B include PEG 6000 utilized in the working examples. Regarding claims 6-8: The hydrophilic polyhydric alcohol based polymer having a terminal hydroxy group is polyethylene glycol having a weight average molecular weight of 500-10,000 daltons on average ([0048] Buchholz). A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson , 315 F.3d 1325, 1329 (Fed. Cir. 2003). Regarding claim 9 : A solidification and extrusion molded article comprising the glycolic acid copolymer composition is disclosed. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT T BUTCHER whose telephone number is (571)270-3514. The examiner can normally be reached Telework M-F 9-5 Pacific Time Zone. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lanee Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROBERT T BUTCHER/Primary Examiner, Art Unit 1764 Application/Control Number: 18/552,360 Page 2 Art Unit: 1764 Application/Control Number: 18/552,360 Page 3 Art Unit: 1764