FINAL 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 .
Status of Claims
Receipt is acknowledged of claim amendments filed on 30 October 2025.
Claim 1 has been amended.
Claims 7-8 are cancelled.
Claims 10-21 remains withdrawn from consideration.
Claims 1-6, 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Rejections Withdrawn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 as being unpatentable over LANGER (US 2013/0231412 A1, publication date of 5 September 2013) in view of 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Arrest, Apoptosis and Inhibits Invasion in Gastric Cancer”, PLOS ONE, 14 pages, published 26 September 26, 2016), is withdrawn in view of the claim amendments on 30 October 2025.
The provisional rejection of claims 1-6, 9 and 22 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 LANGER (US 2013/0231412 A1, publication date of 5 September 2013) in view of 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Arrest, Apoptosis and Inhibits Invasion in Gastric Cancer”, PLOS ONE, 14 pages, published 26 September 26, 2016), is withdrawn in view of the claim amendments on 30 October 2025.
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 1-6, 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 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).
Bruggeman (WO 2008/144514 A2) is primarily directed towards including polyol-based polymers and pharmaceutical compositions (abstract).
Regarding claims 1, 3 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 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]).
Regarding claim 2, Bruggeman discloses that polymer can have a shape of including particles (paragraphs [00176] and [00204], claim 65).
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 (e.g., at least one additional agent) is PFK15. The deficiencies is made up for by the teachings of Nathan and Zhu.
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]).
Zhu is primarily directed towards PFK15, a small molecule inhibitor of PFKFB3, that is a promising anticancer drug for treating gastric cancer (abstract).
Regarding claims 1 and 3-6, Zhu teaches that PFK15, a small molecular PFKFB3 inhibitor, displayed potent and selective activity against PFKFB3 and displayed antitumor capacity in various animal models (page 2/14, third paragraph). Zhu teaches that PFK15 exhibited anti-glycolytic effect in gastric cancer cells and further demonstrated that the antitumor activities of PFK15 were associated with cell apoptosis, cell cycle block and cell invasion inhibition in gastric cancer models. Zhu teaches that PFK15 is a promising anti-cancer drug for treating gastric cancer by targeting aerobic glycolysis (page 12/14, last 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 biologically active agent (e.g., additional agent) 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 encapsulates a therapeutic agent in the form of a particle (e.g., polymeric particle), wherein the therapeutic agent is PFK15. 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 gastric cancer by including PFK15 as a biologically active agent, which is a small molecule and an anti-cancer for gastric cancer as taught by Zhu. 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]). Zhu teaches that PFK15, a small molecular PFKFB3 inhibitor, displayed potent and selective activity against PFKFB3 and displayed antitumor capacity in various animal models (page 2/14, third paragraph). Zhu teaches that PFK15 exhibited anti-glycolytic effect in gastric cancer cells and further demonstrated that the antitumor activities of PFK15 were associated with cell apoptosis, cell cycle block and cell invasion inhibition in gastric cancer models. Zhu teaches that PFK15 is a promising anti-cancer drug for treating gastric cancer by targeting aerobic glycolysis (page 12/14, last paragraph). 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]).
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 1-6, 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 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).
Regarding instant claims 1-3 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 deficiency is made up for by the teachings of Bruggeman, Nathan and Zhu.
Bruggeman (WO 2008/144514 A2) is primarily directed towards including polyol-based polymers and pharmaceutical compositions (abstract).
Regarding claims 1, 3 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 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]).
Zhu is primarily directed towards PFK15, a small molecule inhibitor of PFKFB3, that is a promising anticancer drug for treating gastric cancer (abstract).
Regarding claims 4-6, Zhu teaches that PFK15, a small molecular PFKFB3 inhibitor, displayed potent and selective activity against PFKFB3 and displayed antitumor capacity in various animal models (page 2/14, third paragraph). Zhu teaches that PFK15 exhibited anti-glycolytic effect in gastric cancer cells and further demonstrated that the antitumor activities of PFK15 were associated with cell apoptosis, cell cycle block and cell invasion inhibition in gastric cancer models. Zhu teaches that PFK15 is a promising anti-cancer drug for treating gastric cancer by targeting aerobic glycolysis (page 12/14, last 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 gastric cancer because suitable actives for polymers of including α-ketoglutarate to encapsulate and provide delivery includes small organic molecules and for treating cancers, which Bruggeman teaches, and PFK15 is a small molecule that is a promising anti-cancer drug for treating gastric cancer, which Zhu 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]). Zhu teaches that PFK15, a small molecular PFKFB3 inhibitor, displayed potent and selective activity against PFKFB3 and displayed antitumor capacity in various animal models (page 2/14, third paragraph). Zhu teaches that PFK15 exhibited anti-glycolytic effect in gastric cancer cells and further demonstrated that the antitumor activities of PFK15 were associated with cell apoptosis, cell cycle block and cell invasion inhibition in gastric cancer models. Zhu teaches that PFK15 is a promising anti-cancer drug for treating gastric cancer by targeting aerobic glycolysis (page 12/14, last paragraph). 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]).
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 claim(s) 1-6, 9 and 22 have been considered but are moot because the new ground of rejection described above that is necessitated by the claim amendments filed 30 October 2025 relies of different references than the references applied in the prior rejection of record.
Thus, for the reasons of record and for the reasons presented above claims 1-6, 9 and 22 are rejected under 35 U.S.C. 103(a) and provisionally rejected on the ground of nonstatutory double patenting.
Conclusion and Correspondence
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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.
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, David Blanchard can be reached on (571) 272-0827. 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.
/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600