DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's arguments in the reply filed on 2/26/2026 is acknowledged. The traversal is on the ground(s) that the structures of Formulas 5-8 share a common structure. These arguments are found persuasive and thereby the restriction requirement set forth on 12/11/2025 is withdrawn.
Claim Objections
Claim 1 is object to because it recites “of the total composition” in lines 7-8. It is suggested to be changed to “the pharmaceutical composition” for consistency.
Claim Rejections - 35 USC § 112
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.
Claim(s) 1-3, 5-6, 8-37, and 40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 because:
Claim 1 recites the limitation "the polyester" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the claim will be interpreted as “wherein the at least three polyester arms comprise poly(ε-caprolactone-co-lactic acid)”.
Claims 2-3, 5-6, 8-37 and 40 are also rejected because they are dependent on a rejected base claim.
Allowable Subject Matter
The present claims are allowable over the closest references: WO2019/016233 (as found on the IDS dated 7-6-2023). Citations are taken from the US equivalent document of US2020/0163873 to Roberge et al.
The following is a statement of reasons for the indication of allowable subject matter:
Roberge teaches a pharmaceutical composition [title] comprising biodegradable triblock and diblock copolymers [abstract] wherein the diblock copolymers are a combination of end-capped poly(ethylene-glycol) (i.e., polyether) and a block selected from a list comprising poly(lactic-co-glycolic acid) (PLGA) [0151] wherein the block copolymers are substantially insoluble in an aqueous solution [0062]. Roberge’s composition further comprises a pharmaceutically active ingredient [0043] and an organic solvent in an amount of 35-75 wt% of the total composition [0190].
Roberge does not teach or fairly suggest a multi-branched copolymer comprising at least three polyester arms, wherein the at least three polyester arms comprise poly(ε-caprolactone-co-lactic acid) attached to a central core which comprises a polyether. Moreover, Roberge teaches the poly(ethylene glycol) is specifically an end-capped polyethylene glycol wherein one terminal hydroxyl group is reacted with a capping group that is a chemical group which does not contain a chemical function susceptible to react with cyclic esters or other esters [0101]. As such, it would not have been obvious to one of ordinary skill in the art to attempt to modify this copolymer into a multi-branched copolymer as Roberge teaches capping the terminal group to prevent further reactions.
Double Patenting
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.
Claims 1-3, 5-6, 8-37, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. US 12,485,139 to Roberge (herein after US139’). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims have a different amount of solvent (i.e., at least 20 wt% of the total composition) and the polyester is specified to be poly(ε-caprolactone-co-lactic acid). However, these limitations are within the scope of the co-pending claims as the co-pending claims set forth an organic solvent in an amount of at least 25 wt% [US139’, Claim 1] (thereby overlapping with at least 20 wt%) and that the polyester is formed from at least one polymer or copolymer such as poly(epsilon-caprolactone) and poly(lactic acid) [US139’, Claim 17] (i.e., poly(ε-caprolactone-co-lactic acid)).
Claims 1-3, 5-6, 8-37, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. US 12,427,165 to Roberge (herein after US165’). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims have a different amount of solvent (i.e., at least 20 wt% of the total composition), a different molecular weight of the polyether (10 kDa or less) and the polyester is specified to be poly(ε-caprolactone-co-lactic acid). However, these limitations are within the scope of the co-pending claims as the co-pending claims set forth an organic solvent in an amount of at least 25 wt% [US139’, Claim 1] (thereby overlapping with at least 20 wt%), a molecular weight of the polyether is 5 kDa or less [US139’ Claim 2] (thereby overlapping with 10 kDa or less) and that the polyester is formed from poly(lactic acid) [US139’, Claim 1] and further comprises at least one polymer or copolymer such as poly(epsilon-caprolactone) [US139’, Claim 12] (i.e., poly(ε-caprolactone-co-lactic acid)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner
should be directed to Devin Darling whose telephone number is (703) 756-5411. The examiner can normally be reached M-F 9:00-5:00.
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, Arrie Lanee Reuther can be reached on (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.
/DEVIN MITCHELL DARLING/Examiner, Art Unit 1764
/ARRIE L REUTHER/Supervisory Primary Examiner, Art Unit 1764
Prosecution Insights