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 .
Priority
This application, filed 22 June, 2023, is a national stage application of PCT/US2021/064478, filed 21 December, 2021, which claims the benefit of U.S. Provisional Application 63/131,459, filed 29 December, 2020.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 23 February, 2026, in the matter of Application N° 18/258,903. Said documents have been entered on the record.
Claims 1 and 4 are amended. No new matter was introduced.
Thus, Claims 1-12 and 14-21 represent all claims currently under consideration.
Response to Amendments/Arguments
Applicant’s amendments are sufficient to overcome the objection and the previous rejections of Claims under 35 U.S.C. 102(a)(1) and 103.
Regarding the rejection of Claim 15 under 35 U.S.C. 112(b), Applicant contends that the rejection was based on the use of identifier numbers (e.g., compounds numbered 3, 4, and 6-189) rather than reciting chemical structures, and argues that such identification is sufficient (Remarks, Pg. 11.) This argument is not persuasive because it does not address the actual basis of the rejection.
The rejection under 35 U.S.C. 112(b) is not premised on the use of compound numbering per se, but rather on the improper incorporation of essential claim limitations by reference to the specification. Specifically, the claim recites “…compounds numbered 3, 4, and 6-189, in the above specification…”, which requires the reader to consult the specification to determine the identity and scope of the claimed subject matter.
Claims must particularly point out and distinctly claim the subject matter regarded as the invention. The metes and bounds of the claim must be ascertainable from the claim language itself, without requiring reference to the specification to supply essential limitations.
Therefore, the rejection under 35 U.S.C. 112(b) is maintained.
Additionally, Applicant contends that the provisional nonstatutory double patenting rejection should be deferred until the claims are in condition for allowance. This argument is acknowledged; however, the double patenting rejection is maintained. Resolution of this rejection, for example by appropriate amendment or the filing of a terminal disclaimer, will be required prior to allowance.
Claim Rejections - 35 USC § 112 (MAINTAINED)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “…one of the compounds numbered 3, 4, and 6-189, in the above specification…” The recitation renders the claim indefinite because the metes and bounds of the claimed subject matter cannot be determined without reference to the specification. The claim thus improperly relies upon incorporation of subject matter by reference rather than setting forth all essential limitations within the claim itself.
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) See MPEP § 2173.05(s).
Double Patenting (MAINTAINED)
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 1-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18 of copending Application No. 18/257,003 in view of St. John and Fotsch (J. Med. Chem. 2012, 55, 6002−6020.)
The claims of the instant application are not patentably distinct from those of the copending application, as both are directed to compounds and compositions having the same overall scaffold and pharmacophore, differing only in the position of a ring nitrogen within the heteroaryl moiety.
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Instant Formula I
‘003 Formula I
It would have been prima facie obvious to one of ordinary skills in the art, at the time the invention was made, to modify the heteroaryl ring of the compound disclosed in the copending application by shifting the position of the nitrogen atom within the ring, as such positional interchange represents a routine and conservative variation in medical chemistry. One of ordinary skill in the art would have been motivated to make this modification in view of St. John and Fotsch, which teaches that altering the location of heteroatoms within aromatic systems in a common strategy to mitigate metabolic instability and optimize physicochemical properties of heterocycles during drug discovery. St. John and Fotsch explicitly demonstrates positional isomerism in metabolite identification studies (2012, Pg. 6013, Figure 37) as an established optimization technique. One would have had a reasonable expectation of success, as the modification does not alter the overall structure of pharmacophore of the compound, preserves aromaticity and substituent orientation, and is shown in the art to produce analogues with similar or improved potency and metabolic stability.
The methods claims likewise are not patentably distinct, as they are directed to the same therapeutic use of the same compounds and compositions that differ only by the above described, routine nitrogen positional variation.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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 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 Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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