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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 May 2026 has been entered.
Status of Claims
Receipt is acknowledged of the claim amendments filed on 08 May 2026.
Claims 1 and 5-6 have been amended.
Claims 7-8 are cancelled.
Claims 10-21 remains withdrawn from consideration.
In light of the claim amendments claims 3-6 are withdrawn from consideration because Applicant elected PFK15 as a species for an at least one additional agent in the response filed 03 July 2025.
Consequently, claims 1-2, 9 and 22 are examined herein to the extent that the at least one additional agent is PFK15, e.g., applicant's elected species.
Rejections Withdrawn
The rejection of claims 1-6, 9 and 22 under 35 U.S.C. 103(a) as being unpatentable over BRUGGEMAN (WO 2008/144514 A2, 27 November 2008) in view of NATHAN (EP 1431327 A1, PUBLICATION DATE OF 23 June 2004) and ZHU (“PFK15, a Small Molecule Inhibitor of PFKFB3, Induces Cell Cycle Arrest, Apoptosis and Inhibits Invasion in Gastric Cancer”, PLOS ONE, 14 pages, published 26 September 26, 2016), is withdrawn in view of the claim amendments filed 08 May 2026 and after further consideration and an updated search.
New Grounds of Rejections
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over BRUGGEMAN (WO 2008/144514 A2, 27 November 2008) in view of NATHAN (EP 1431327 A1, PUBLICATION DATE OF 23 June 2004) and ZOU (“Inhibition of 6-phosphofructo-2-kinase suppresses fibroblast-like synoviocytes-mediated synovial inflammation and joint destruction in rheumatoid arthritis”, British Journal of Pharmacology, 174, pages 893-908, 2017).
Bruggeman is primarily directed towards including polyol-based polymers and pharmaceutical compositions (abstract).
Regarding claims 1-2 and 9, Bruggeman discloses polymers from including condensing polyols with polycarboxylic acids (paragraph [0006]). Bruggeman discloses a pharmaceutical compositions comprising the polymer and a biologically active agent (e.g., additional agent) (paragraph [0007]). Bruggeman discloses that the polymers are including biodegradable and biocompatible (paragraph [0006]). Bruggeman discloses embodiments where the biologically active agent is entrapped (e.g., encapsulated) by the polymer (paragraph [00193]). Bruggeman discloses that the polymer and a polymer composition can be used to treat a disease or disorder that includes arthritis and inflammation (paragraph [00205-00207]). Bruggeman discloses that the polycarboxylic acid includes a metabolite that further includes α-ketoglutaric acid (paragraph [00163]). Bruggeman discloses that biologically active agent includes a small organic molecule (paragraph [00197]).
Regarding claim 22, although the claims recite a kit, no positive recitation of the kit ingredients/elements distinguishes the claim over the reference(s). Therefore, the references read on the claimed kit. Further, it is a well-known convention in the art to place the recited elements in a kit for the advantages of convenience and economy.
Bruggeman does not specifically teach that the polymer comprises a diol. Bruggeman does not specifically teach that the biologically active agent is PFK15. The deficiencies is made up for by the teachings of Nathan and Zou.
Nathan is primarily directed towards biodegradable and biocompatible polymers (abstract).
Regarding claim 1, Nathan teaches polymers including aliphatic polyesters that degrade by a hydrolytic mechanism in the body and then are absorbed by the body (paragraph [0004]). Nathan teaches that alkyd-type polyesters are prepared by the polycondensation of including a polyol and polyacid (paragraph [0008]). Nathan teaches that polyol suitable for the polyester includes 1,10-decanediol (paragraph [0018]).
Zou is primarily directed towards targeting PFKFB3 to prevent synovial inflammation and joint destruction in RA (rheumatoid arthritis) (abstract).
Regarding claim 1, Zou teaches that rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by chronic synovial inflammation and progressive joint destruction (e.g., inflammatory or autoimmune disease or disorder) (page 894, first column, first paragraph). Zou teaches that a study showed that increased glycolytic metabolism in RA fibroblast-like synoviocytes contributes to synovial inflammation and joint damage, suggesting that glycolytic suppression might be an effective therapeutic strategy for inflammatory arthritis (page 894, first column, second paragraph). Zou teaches that only PFKFB3 expression was increased in RA FLS compared with the expression levels in OA FLS (page 896, second column, last paragraph). Zou teaches that PFK15 is a potent and selective inhibitor of PFKFB3 (page 898, first column, first paragraph). Zou teaches that PFKFB3 inhibition decreased the expression of proinflammatory cytokines, migration, invasion and proliferation of RA FLSs. The NF-B and p38, JNK and ERK MAPK pathways were blocked by the PFKFB3 inhibitor. PFKFB3 inhibition also reduced glucose uptake and lactate secretion by RA FLSs. Treatment with PFK15 in vivo markedly reduced the severity of synovial hyperplasia, inflammatory cell infiltration and joint destruction in mice with CIA (collagen-induced arthritis) (page 902, first column, first paragraph). Zou teaches that the administration of PFK15 in vivo did not result in toxicity in mice (page 902, second column, third paragraph).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising a PFK15 and polymer formed from a polyol including 1, 10-decanediol and a polycarboxylic acid including α-ketoglutaric acid (e.g., polymer of α-ketoglutarate), wherein the polymer encapsulates PFK15 in the form of a particle (e.g., polymeric particle). The person of ordinary skill in the art would have been motivated to make those modifications: 1) because other known polyols that can be used to make biodegradable polymers for pharmaceutical compositions includes 1, 10-decanediol, as taught by Nathan, which one of ordinary skill in the art would expect to be suitable as the polyol in the biodegradable polymer of Bruggeman and substituted in 1, 10-decanediol as the polyol of Bruggeman; and 2) to obtain a composition that treats rheumatoid arthritis, an inflammatory arthritis disease, by including PFK15 as a biologically active agent, which is a small molecule and can be administered to treat rheumatoid arthritis as taught by Zou. The person of ordinary skill in the art would have reasonably expected success because Bruggeman discloses polymers from including condensing polyols with polycarboxylic acids (paragraph [0006]). Bruggeman discloses a pharmaceutical compositions comprising the polymer and a biologically active agent (paragraph [0007]). Bruggeman discloses that the polymers are including biodegradable and biocompatible (paragraph [0006]). Bruggeman discloses that the polymer and a polymer composition can be used to treat a disease or disorder that includes arthritis and inflammation (paragraph [00205-00207]). Bruggeman discloses that the polycarboxylic acid includes a metabolite that further includes α-ketoglutaric acid (paragraph [00163]). Bruggeman discloses that biologically active agent includes a small organic molecule (paragraph [00197]). Nathan teaches polymers including aliphatic polyesters that degrade by a hydrolytic mechanism in the body and then are absorbed by the body (paragraph [0004]). Nathan teaches that alkyd-type polyesters are prepared by the polycondensation of including a polyol and polyacid (paragraph [0008]). Nathan teaches that polyol suitable for the polyester includes 1,10-decanediol (paragraph [0018]). Zou teaches that treatment with PFK15 in vivo markedly reduced the severity of synovial hyperplasia, inflammatory cell infiltration and joint destruction in mice with CIA (collagen-induced arthritis) (page 902, first column, first paragraph). Zou teaches that the administration of PFK15 in vivo did not result in toxicity in mice (page 902, second column, third paragraph).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 9 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 9 and 13 of copending Application No. 17/611,758 (reference application, cited as US 20220226499 in IDS filed 07/01/2025 (9 pages), hereafter ‘758) in view of BRUGGEMAN (WO 2008/144514 A2, 27 November 2008), NATHAN (EP 1431327 A1, PUBLICATION DATE OF 23 June 2004) and ZOU (“Inhibition of 6-phosphofructo-2-kinase suppresses fibroblast-like synoviocytes-mediated synovial inflammation and joint destruction in rheumatoid arthritis”, British Journal of Pharmacology, 174, pages 893-908, 2017).
Regarding instant claims 1 and 9, claim 1 of ‘758 recites a particle comprising a polymer of a metabolite. Claim 3-4 recites that the metabolite is α-ketoglutarate. Claim 9 of ‘758 recites that the particle encapsulates an active agent. Claim 13 of ‘758 recites a pharmaceutical composition comprising a particle of claim 1.
Regarding instant claim 22, although the claims recite a kit, no positive recitation of the kit ingredients/elements distinguishes the claim over the reference(s). Therefore, the references read on the claimed kit. Further, it is a well-known convention in the art to place the recited elements in a kit for the advantages of convenience and economy.
The claims of ‘758 do not specifically teach that the polymer comprises a diol. The claims of ‘758 do not specifically teach that the active is PFK15. The deficiencies are made up for by the teachings of Bruggeman, Nathan and Zou.
Bruggeman (WO 2008/144514 A2) is primarily directed towards including polyol-based polymers and pharmaceutical compositions (abstract).
Regarding claims 1 and 9, Bruggeman discloses polymers from including condensing polyols with polycarboxylic acids (paragraph [0006]). Bruggeman discloses that the polymer and a polymer composition can be used to treat a disease or disorder that includes arthritis and inflammation (paragraph [00205-00207]). Bruggeman discloses that the polymers are including biodegradable and biocompatible (paragraph [0006]). Bruggeman discloses that the polymer and a polymer composition can be used to treat a disease or disorder that includes cancer (paragraph [00205-00207]). Bruggeman discloses that the polycarboxylic acid includes a metabolite that further includes α- ketoglutaric acid (paragraph [00163]). Bruggeman discloses that biologically active agent includes a small organic molecule (paragraph [00197]).
Nathan is primarily directed towards biodegradable and biocompatible polymers (abstract).
Regarding claim 1, Nathan teaches polymers including aliphatic polyesters that degrade by a hydrolytic mechanism in the body and then are absorbed by the body (paragraph [0004]). Nathan teaches that alkyd-type polyesters are prepared by the polycondensation of including a polyol and polyacid (paragraph [0008]). Nathan teaches that polyol suitable for the polyester includes 1,10-decanediol (paragraph [0018]).
Zou is primarily directed towards targeting PFKFB3 to prevent synovial inflammation and joint destruction in RA (rheumatoid arthritis) (abstract).
Regarding claim 1, Zou teaches that rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by chronic synovial inflammation and progressive joint destruction (e.g., inflammatory or autoimmune disease or disorder) (page 894, first column, first paragraph). Zou teaches that a study showed that increased glycolytic metabolism in RA fibroblast-like synoviocytes contributes to synovial inflammation and joint damage, suggesting that glycolytic suppression might be an effective therapeutic strategy for inflammatory arthritis (page 894, first column, second paragraph). Zou teaches that only PFKFB3 expression was increased in RA FLS compared with the expression levels in OA FLS (page 896, second column, last paragraph). Zou teaches that PFK15 is a potent and selective inhibitor of PFKFB3 (page 898, first column, first paragraph). Zou teaches that PFKFB3 inhibition decreased the expression of proinflammatory cytokines, migration, invasion and proliferation of RA FLSs. The NF-B and p38, JNK and ERK MAPK pathways were blocked by the PFKFB3 inhibitor. PFKFB3 inhibition also reduced glucose uptake and lactate secretion by RA FLSs. Treatment with PFK15 in vivo markedly reduced the severity of synovial hyperplasia, inflammatory cell infiltration and joint destruction in mice with CIA (collagen-induced arthritis) (page 902, first column, first paragraph). Zou teaches that the administration of PFK15 in vivo did not result in toxicity in mice (page 902, second column, third paragraph).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a pharmaceutical composition comprising a particle comprising a polymer of α-ketoglutarate and a polyol including 1,10-decanediol that encapsulates an active agent, wherein the active agent is PFK15. The person of ordinary skill in the art would have been motivated to make those modifications: 1) to obtain a composition for treating rheumatoid arthritis, an inflammatory arthritis disease, because suitable actives for polymers of including α-ketoglutarate to encapsulate and provide delivery includes small organic molecules and actives for treating including arthritis and inflammation, which Bruggeman teaches, and PFK15 is a small molecule that that can be administered for treating rheumatoid arthritis, an inflammatory arthritis disease, which Zou teaches; and 2) because other known polyols that can be used to make biodegradable polymers for pharmaceutical compositions with polycarboxylic acids includes 1, 10-decanediol, as taught by Nathan, which one of ordinary skill in the art would expect to be suitable as a polyol in the polymer of α-ketoglutarate (e.g., polycarboxylic acid) that is recited in the claims of ‘758. The person of ordinary skill in the art would have reasonably expected success because Bruggeman discloses polymers from including condensing polyols with polycarboxylic acids (paragraph [0006]). Bruggeman discloses a pharmaceutical compositions comprising the polymer and a biologically active agent (e.g., additional agent) (paragraph [0007]). Bruggeman discloses that the polymers are including biodegradable and biocompatible (paragraph [0006]). Bruggeman discloses that the polymer and a polymer composition can be used to treat a disease or disorder that includes cancer (paragraph [00205-00207]). Bruggeman discloses that the polycarboxylic acid includes a metabolite that further includes α- ketoglutaric acid (paragraph [00163]). Bruggeman discloses that biologically active agent includes a small organic molecule (paragraph [00197]). Nathan teaches polymers including aliphatic polyesters that degrade by a hydrolytic mechanism in the body and then are absorbed by the body (paragraph [0004]). Nathan teaches that alkyd-type polyesters are prepared by the polycondensation of including a polyol and polyacid (paragraph [0008]). Nathan teaches that polyol suitable for the polyester includes 1,10-decanediol (paragraph [0018]). Zou teaches that treatment with PFK15 in vivo markedly reduced the severity of synovial hyperplasia, inflammatory cell infiltration and joint destruction in mice with CIA (collagen-induced arthritis) (page 902, first column, first paragraph). Zou teaches that the administration of PFK15 in vivo did not result in toxicity in mice (page 902, second column, third paragraph).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments will be addressed as they pertain to the new grounds of rejection above.
Applicant’s arguments with respect to claims 1-2, 9 and 22 have been considered but are moot because the new ground of rejection above over Bruggeman, Nathan and Zou.
Thus, for the reasons of record and for the reasons presented above claims 1-2, 9 and 22 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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