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 .
Priority
Instant application 17/439,763 filed on 09/15/2021 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
The amendment filled on 12/05/2025 has been entered.
Claims 1, 3-5, and 20-22 are pending.
Information Disclosure Statement
All references from IDS documents received 09/01/2022, 01/14/2022, and 04/28/2025 have been considered unless marked with strikethrough
Response to Arguments/Amendments
The amendment filled on 07/09/2025 has been entered.
Applicant amended claim 1 and limited the method to treating breast cancer, prostate cancer, ovarian cancer, melanoma, and glioblastoma. The recited cancers are documented as depend on fatty acid metabolism.
Further, Applicant cancelled claim 2.
Applicant’s amendment and Applicant’s arguments have overcome the 112(a) rejection of record; therefore, the 112 rejection of record are withdrawn.
However, upon further consideration, a new ground(s) of rejection is made.
Election/Restrictions
Applicant’s species election of compound of formula (X) and prostate cancer in the reply filed on 12/09/2024 is acknowledged.
Claims 1, 3-5 and 20-22 read on the elected species.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries 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, 3-5 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Camarda (Camarda, R., Zhou, A., Kohnz, R. et al. Inhibition of fatty acid oxidation as a therapy for MYC-overexpressing triple-negative breast cancer. Nat Med 22, 427–432 (2016)) in view of Newell (US-20090258064-A1) and in view of Levin (US-20180360975-A1, publication date: December, 20, 2018).
The applied reference, US-20180360975-A1, has a common inventor with the instant application. However, the instant application lists additional Inventors and a different Applicant.
Based upon the earlier publication date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1).
Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Camarda teaches inhibition of fatty acid oxidation is effective as therapy for breast cancer (see title).
Further, Camarda teaches administration of etomoxir (see page 431, second paragraph) and inhibition of FAO as a therapeutic strategy for breast cancer (see last paragraph):
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Camarda is silent about prostate cancer and Camarda does not teach the elected compound, 2-(4-(2,3,4-trimethoxybenzyl)piperazin-1-yl)ethyl nicotinate.
Newell discloses method of treating cancer (paragraph 0024):
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Newell teaches fatty acid metabolism inhibitors including trimetazidine for treatments of cancer (paragraphs 0028 and 0166):
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Newell teaches cancer include prostate cancer, breast cancer, ovarian cancer, melanoma and glioblastoma (see paragraph 0195).
Regarding instant claim 20, Newell teaches combination with one or more chemotherapeutic agent:
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Regarding instant claims 21-22, Newell teaches the method may be used in conjugation with chemotherapy:
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Regarding instant claims 3-5, Newell teaches dosing amounts, dosing schedule and route of administration may be adjusted to achieve desired drug levels:
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Further, regarding instant claims 3-4, Newell teaches single and multiple unit doses (paragraphs 0240-0245).
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Regarding instant claim 5, Newell teaches oral and intravenous administrations (paragraph 0247):
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Newell does not teach the elected compound, 2-(4-(2,3,4-trimethoxybenzyl)piperazin-1-yl)ethyl nicotinate.
Levin teaches compounds of formula A-L-C for treatment of any disease that may be treated using trimetazidine with more efficacious results and fewer side effects (paragraphs 0033 and 0045):
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Further, Levin teaches compounds of formulas IX and the elected species (formula X):
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Furthermore, Levin discloses a method of treating diseases of metabolic dysfunction with the disclosed compounds (see claim 27):
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Since Camarda teaches inhibition of fatty acid oxidation as therapy for breast cancer, Newell discloses method of treating cancer comprising a compound that inhibits fatty acids metabolism, Levin teaches a method of treating diseases of metabolic dysfunction, Levin discloses compounds of Formula (VII) including the elected species (compound of formula (X)) - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one fatty acid metabolism inhibitor, the trimetazidine disclosed by Newell or etoxomir disclosed by Camarda for a different fatty acid metabolism inhibitor, 2-(4-(2,3,4-trimethoxybenzyl)piperazin-1-yl)ethyl nicotinate disclosed by Levin, and use it for the same purpose, treating cancer, with a reasonable expectation of success. Since prior art discloses various compounds as inhibitors of fatty acid oxidation, one of ordinary skill would have understood that the structure of the compound is not necessarily important (see the compounds disclosed by Newell and Camarda). A skilled artisan would expect success after replacing one fatty acid oxidation inhibitor for a different fatty acid oxidation inhibitor.
Secondly, Applying KSR prong (A) - Combining prior art elements according to known methods to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat a metabolic dysfunction disorder such as cancer with compounds of Formula (VII) of Levin, arriving at the claimed methodology with a reasonable expectation of success, as compounds of Formula (VII) are art-recognized at treating diseases of a metabolic dysfunction.
Thirdly, Applying KSR prong (C) - Use of known technique to improve similar devices (methods, or products) in the same way – it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to improve the method disclosed by Camarda and Newell because Levin teaches compounds of formula A-L-C (including the elected species) for treatment of any disease that may be treated using trimetazidine with more efficacious results and fewer side effects.
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 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10556013 in view of Newell (US-20090258064-A1) and in view of Camarda (Camarda, R., Zhou, A., Kohnz, R. et al. Inhibition of fatty acid oxidation as a therapy for MYC-overexpressing triple-negative breast cancer. Nat Med 22, 427–432 (2016)).
The claims of the U.S. Patent No. 10556013 recite a compound represented by formula (X) (the elected species):
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The claims of U.S. Patent No. 10556013 are silent about a method of treating cancer.
However, Newell discloses method of treating cancer (paragraph 0024):
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Newell teaches cancer include prostate cancer, breast cancer, ovarian cancer, melanoma and glioblastoma (see paragraph 0195).
Newell teaches fatty acid metabolism inhibitors including trimetazidine for treatments of cancer (paragraphs 0028 and 0166):
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Regarding instant claim 20, Newell teaches combination with one or more chemotherapeutic agent:
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Regarding instant claims 21-22, Newell teaches the method may be used in conjugation with chemotherapy:
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Regarding instant claims 3-4, Newell teaches single and multiple unit doses (paragraphs 0240-0245).
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Further, regarding instant claim 5, Newell teaches oral and intravenous administrations (paragraph 0247).
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In addition, Camarda teaches inhibition of fatty acid oxidation as therapy for breast cancer (see title).
Further, Camarda teaches administration of etomoxir (see page 431, second paragraph) and inhibition of FAO as a therapeutic strategy for breast cancer (see last paragraph).
Since the claims of U.S. Patent No. 10556013 recite the compound of formula (X), Newell and Camarda teaches fatty acid metabolism inhibitors including trimetazidine and etomoxir for treatments of cancer - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one fatty acid metabolism inhibitor, the trimetazidine disclosed by Newell or etomoxir disclosed by Camarda for a different fatty acid metabolism inhibitor, the 2-(4-(2,3,4-trimethoxybenzyl)piperazin-1-yl)ethyl nicotinate recited in the claims of U.S. Patent No. 10556013 and use it for the same purpose, treating cancer, with a reasonable expectation of success. A skilled artisan would have been motivated to improve the method disclosed by Newell. Since prior art discloses various compounds as inhibitors of fatty acid oxidation, one of ordinary skill would have understood that the structure of the compound is not necessarily important (see the compounds disclosed by Newell and Camarda). A skilled artisan would expect success after replacing one fatty acid oxidation inhibitor for a different fatty acid oxidation inhibitor.
Claims 1, 3-5 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10918728 in view of Newell (US-20090258064-A1) Camarda (Camarda, R., Zhou, A., Kohnz, R. et al. Inhibition of fatty acid oxidation as a therapy for MYC-overexpressing triple-negative breast cancer. Nat Med 22, 427–432 (2016)).
The claims of the U.S. Patent No. 10918728 recite a pharmaceutical composition comprising a controlled release formulation of compound represented by formula (X) (the elected species):
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The claims of U.S. Patent No. 10918728 are silent about a method of treating cancer.
However, Newell discloses method of treating cancer (paragraph 0024) including prostate cancer (paragraph 0195). Newell teaches fatty acid metabolism inhibitors including trimetazidine for treatments of cancer (paragraphs 0028 and 0166). Regarding instant claim 20, Newell teaches combination with one or more chemotherapeutic agent (paragraph 0012). Regarding instant claims 21-22, Newell teaches the method may be used in conjugation with chemotherapy (paragraph 0194). Regarding instant claims 3-4, Newell teaches single and multiple unit doses (paragraphs 0240-0245).
Further, regarding instant claim 5, Newell teaches oral and intravenous administrations (paragraph 0247).
In addition, Camarda teaches inhibition of fatty acid oxidation as therapy for breast cancer (see title).
Further, Camarda teaches administration of etomoxir (see page 431, second paragraph) and inhibition of FAO as a therapeutic strategy for breast cancer (see last paragraph).
Since the claims of U.S. Patent No. 10918728 recite the compound of formula (X), Newell teaches fatty acid metabolism inhibitors including trimetazidine for treatments of cancer and Camarda teaches inhibition of fatty acid oxidation as therapy for breast cancer (see title) - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one fatty acid metabolism inhibitor, trimetazidine, disclosed by Newell, or etomoxir disclosed by Camarda for a different fatty acid metabolism inhibitor, the 2-(4-(2,3,4-trimethoxybenzyl)piperazin-1-yl)ethyl nicotinate recited in the claims of U.S. Patent No. 10918728, and use it for the same purpose, treating cancer, with a reasonable expectation of success. A skilled artisan would have been motivated to improve the method disclosed by Newell. Since prior art discloses various compounds as inhibitors of fatty acid oxidation, one of ordinary skill would have understood that the structure of the compound is not necessarily important (see the compounds disclosed by Newell and Camarda). A skilled artisan would expect success after replacing one fatty acid oxidation inhibitor for a different fatty acid oxidation inhibitor.
Claims 1, 3-5 and 20-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 of U.S. Patent No. 11376330 in view of Newell (US-20090258064-A1) Camarda (Camarda, R., Zhou, A., Kohnz, R. et al. Inhibition of fatty acid oxidation as a therapy for MYC-overexpressing triple-negative breast cancer. Nat Med 22, 427–432 (2016)),
The claims of the U.S. Patent No. 11376330 recite a HCL salt of a compound represented by formula (X) (the elected species):
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Further, the claims of the U.S. Patent No. 11376330 recite a pharmaceutical composition formulated for oral administration (claim 5):
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The claims of U.S. Patent No. 11376330 are silent about a method of treating cancer.
However, Newell discloses method of treating cancer (paragraph 0024) including prostate cancer (paragraph 0195). Newell teaches fatty acid metabolism inhibitors including trimetazidine for treatments of cancer (paragraphs 0028 and 0166). Regarding instant claim 20, Newell teaches combination with one or more chemotherapeutic agent (paragraph 0012). Regarding instant claims 21-22, Newell teaches the method may be used in conjugation with chemotherapy (paragraph 0194).
Regarding instant claims 3-4, Newell teaches single and multiple unit doses (paragraphs 0240-0245). Further, regarding instant claim 5, Newell teaches oral and intravenous administration (paragraph 0247).
In addition, Camarda teaches inhibition of fatty acid oxidation as therapy for breast cancer (see title).
Further, Camarda teaches administration of etomoxir (see page 431, second paragraph) and inhibition of FAO as a therapeutic strategy for breast cancer (see last paragraph).
Since the claims of U.S. Patent No. 11376330 recite HCl salt of compound of formula (X) and Newell teaches fatty acid metabolism inhibitors including trimetazidine for treatments of cancer -Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one fatty acid metabolism inhibitor, trimetazidine, disclosed by Newell for a different fatty acid metabolism inhibitor, the HCl salt of 2-(4-(2,3,4- trimethoxybenzyl)piperazin-1-yl)ethyl nicotinate, recited in the claims of U.S. Patent No. 11376330 and use it for the same purpose, treating cancer, with a reasonable expectation of success. A skilled artisan would have been motivated to improve the method disclosed by Newell. The skilled artisan would expect that both HCl salt and free base to be useful for the same purpose. Since prior art discloses various compounds as inhibitors of fatty acid oxidation, one of ordinary skill would have understood that the structure of the compound is not necessarily important (see the compounds disclosed by Newell and Camarda). A skilled artisan would expect success after replacing one fatty acid oxidation inhibitor for a different fatty acid oxidation inhibitor.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621