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 .
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 4/29/26 are acknowledged and have been considered. Claims 1-7, 9, 17, 22, 34-36, 41-44, 49-52, 57-59, 65-68, 73-76, and 81 are pending and have no amendments.
Applicant notes that claim 6 was not addressed in any rejection. This was an inadvertent omission. In the previous action, Claim 6 should have been indicated as allowable but objected to as dependent upon a rejected claim. The correct status has been clarified/identified in the instant action.
With regards to the enablement rejection, applicant argues that copending 18/578,932, relied on in the NSDP, does not have an enablement rejection pending, and thus is evidence the instant claims are enabled. While Applicant argues that the related application should control the enablement analysis here, it is noted that each application is examined on its own merits based on the record in that case. It is also noted that enablement has not been raised in ‘932 because the claims are not further considered on the merits as improperly multiply dependent. As such, the claims have not been examined for statutory compliance under any statute. It is inaccurate to insinuate that such absence of a rejection is evidence of enablement. In any event, prosecution positions in related cases can change as the record develops, and the fact that an issue was not previously raised in another application does not establish enablement in the present one or overcome the current concern here (see MPEP § 2164.01, enablement must be evaluated on the record of the present application). As such, the enablement rejection is maintained and restated below.
With regard to the non-statutory double patenting rejection, Applicant argues that the application is in condition for allowance and that the rejection should be withdrawn. This argument is not persuasive. Applicant has not shown that the claims are patentably distinct, and reliance on the earlier filing date of the instant application does not overcome the rejection (see MPEP § 804). In addition, the 35 U.S.C. § 112(a) enablement rejection is maintained (above), and therefore the application is not in condition for allowance.
While Applicant’s arguments were not convincing on their own merits, upon further consideration, the NSDP rejection of claims 1-5, 7, 9, 17, and 22 is withdrawn. The core structure of instant formula I-a has a bridging ring nitrogen:
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that is not found in the copending ‘932:
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, and while it is maintained that the obviousness to substitute a bioisoster at X1, there is nothing in the claims or art that would have led to substituting the X1 in conjunciton with an addition ring substituion. Thus, the rejection as being an obvious variant is unsustainable and is withdrawn. Accordingly, claims 1-5, 7, 9, and 17 are allowed.
Claim 22 remains rejected under 112a, as set forth previously, and below, and is not allowable.
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 remain 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.
Allowable Subject Matter
Claims 1-5, 7, 9, 17, 34-36, 42-44, 50-52, 58-60, 66-68, and 74-76 are allowed.
As set forth above, the core structure of instant formula I-a has a bridging ring nitrogen on the fused ring system:
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that is not found in the closest art (copending application ‘932, discussed above):
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, and it while bioisosteric replacement at X1 might be obvious, to have made that modificaiton in conjunciton with a change of a ring atom in the fused system, that finds no suggestion to make, would not have been obvious.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 571-272-1600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew D Kosar/ Supervisory Patent Examiner, Art Unit 1625
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