DETAILED ACTION
Response to Amendment/Corrective Action
In response to Applicant’s call on 1/23/26, requesting the supervisor review the finality of the Finality/Advisory action, the following corrective action has been taken:
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
The amendment submitted 11/25/25 has been entered.
With entry of the amendment, claims 1-7, 9, 17, 22, 34-36, 41-44, 49-52, 57-60, 65-68, 73-76, and 81 are pending and have been examined on the merits.
Any rejection and/or objection not specifically addressed below in original or modified form is herein withdrawn.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22, 41, 49, 57, 65, 73, and 81 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of the recited diseases with the PDHK inhibitors claimed, does not reasonably provide enablement for preventions of the conditions recited. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claims are drawn generally to treatment or prevention of diseases, such as cancer, mitochondrial disease, Alzheimer’s, and others, via administration of a PDHK inhibitor.
While the art recognizes that the conditions are treatable with PDHK inhibitors, it does not recognize that they are preventable with them, nor are the recognized to be preventable by any known prophylactic therapy. For example, Cleveland Clinic (14 Ways To Limit Your Risk of Alzheimer’s Disease., attached PTO-892) provides that there is no prevention of Alzheimer’s, stating, “There is no 100% guaranteed way to prevent Alzheimer's, given the many factors that can contribute to the onset of the disease.” The specification does not provide guidance on how to overcome such hurdles to prevention, and one of skill in the art would not know how to prevent something, when the art lacks sufficient guidance or recognition of the prevention of the conditions (e.g. dose that would prevent, regimen required, how to identify who would need prevention, when to start the ‘prevention’, etc.), and the specification does not cure this lack of knowledge in the art, and thus it would an undue burden to practice the scope of the invention as claimed.
While the specification reasonably enables therapeutic treatment, it does not enable the prophylactic “preventing” aspect across the full scope of the claims without undue experimentation (see MPEP § 2164). The disclosure lacks sufficient guidance to identify at‑risk subjects, establish timing prior to onset, define prophylactic dosing ranges and duration, or specify reliable predictive biomarkers/endpoints in a highly unpredictable art. Implementing prevention would require extensive screening, and iterative clinical studies to determine effective and safe prophylaxis across patient populations and comorbidities, resulting in an undue burden. Accordingly, claims reciting “preventing” are rejected under 35 U.S.C. § 112(a) for lack of enablement.
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 1-5, 7, 9, 17, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, 15-20, and 32-35 of copending Application No. 18/578,932 (reference application, claim set amendments of 8/22/24) in view of THORNBER (Isosterism and Molecular Modification, attached PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn generally to compounds of formula I-a and their use in methods of inhibiting PDHK and treatments (and prevention) of diseases.
‘932 teaches compounds of formulae I and III,
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and specific species, such as that of ‘932 claims 32-35, e.g.
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, are within the scope of the instant claimed genus. The methods of ‘932 administer the compounds to inhibit PDHK and treat (and prevent) the same diseases.
The compound
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differs from the instant claims in that the ring -O- is instantly claimed as -NH-. Thornber, teaches that -O- and -NH- are classic isosteric replacements, such that substitution of one for the other would be expected to function in the same manner. Thus, the modification of the ring would have been a predictable modification resulting in a PDHK inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 34-36, 42-44, 50-52, 58-60, 66-68, and 74-76 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest art is that of Applicant, found in application 18/578,932. While the compounds may be embraced generally in the generic independent claim, the reference only qualifies under double patenting, and there is nothing in the ‘932 claims that would lead one to make the modifications specific to these compounds.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew D Kosar whose telephone number is (571)272-0913. The examiner can normally be reached Monday-Friday, 7am-3:30pm.
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/Andrew D Kosar/ Supervisory Patent Examiner, Art Unit 1625