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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 14, 2025 has been entered.
Claims Status and Response to Amendments
The amendments filed August 14, 2025 have been acknowledged and entered. Claims 1, 4-6, 8-9, and 14-25 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statement filed on December 17, 2025. All references have been considered except where marked with a strikethrough.
Election/Restriction
The present examination is based on Applicant’s election without traverse of Group I, presently claims 1, 4-6, 8-9, and 14-25, and species of Formula (I) corresponding to B-647, in the response filed September 27, 2024.
As noted previously, the examiner need not extend the search beyond a proper Markush grouping. See MPEP § 803.02. The search has thus been limited to the subgenus indicated below:
Formula I wherein
X is -CH-;
Y is N; and
R2 and R3 together with their mutually-attached N form an unsubstituted C5 heterocycloalkyl group consisting of 1 N atom.
Or the subgenus of Formula (II) wherein
X is -CH-;
Y is N; and
Z is -CR9R10-
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Claim 6 (in full) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 1, 4-5, 8-9, and 14-25 (except for the above indicated subgenus) are withdrawn with regard to prior art search as being drawn to a nonelected species.
Claim Objections
Claims 5, 19-21 and 24 are objected to because of the following informalities:
Claims 19-20 recite the limitation “6-membered" in line 2 in the definition of R2 and R3 which is not supported by claim 1. It is suggested the claim be amended to recite a C5-membered heterocycloalkyl group consisting of one N atom, which is also based on the improper Markush rejection.
Claims 5 and 21 are objected to for having the same scope. Applicant is advised that should claim 5 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 24 is objected to for having blurry structures (examples pictured below). The claim should be amended to provide clear structures of each compound.
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Appropriate correction is required.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Claims Rejections
Improper Markush Grouping Rejection
Claims 1, 8-9, 14-20 and 24-25 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The reasons for this rejection were set forth in the previous Office Action mailed December 10, 2024 and are incorporated herein by reference.
Response to Arguments
Applicant' s arguments filed August 14, 2025 have been fully considered but they are not persuasive.
Applicant states that in the interest of expediting prosecution, claims 1 and 4 are amended and in view of these amendments withdrawal of the rejection is requested (see page 2 of remarks).
Examiner respectfully disagrees because the scope of the claims still includes an improper Markush grouping.
Claim 1 is drawn to wherein R2 and R3 form a heterocycloalkyl group comprising 1 N atom. The claim is thus opened ended and R2 and R3 can form heterocycloalkyl groups comprising additional heteroatoms. This limitation does not limit Formula I to wherein R2 and R3 together with their mutually-attached N form an unsubstituted 6-membered heterocycloalkyl group consisting of 1 N atom. Claims 8 and 14-20 depend from claim 1 and include this limitation of R2 and R3.
Claim 24 includes compounds of Formula (I) wherein variable X is N or CH and variable Y is N or CH. Claim 25 includes compounds of Formula (II) wherein variable X is N or CH, variable Y is N or CH and variable Z is CR9R10, O or S.
The claims are therefore still drawn to numerous different heterocyclic cores.
The rejection is still deemed proper and thus maintained. The rejection could be overcome by amending the claims to recite wherein R2 and R3 form a C5-membered heterocycloalkyl group comprising 1 N atom.
New Rejections/Rejections Necessitated by Applicant Amendment.
Claim Rejections - 35 USC § 112a
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 1, 4-5, 8-9 and 14-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims have been amended to recite 3-10 membered and 3-6 membered heterocycloalkyl (see R1 definitions), 5-10 membered heteroaryl (see definitions of A), and 3-10 membered heterocycloalkyl and 5-10 membered heteroaryl (see R4 definitions). The former definitions (e.g C3-C10 heterocycloalkyl) allowed a minimum of 3 carbons in a heterocycloalkyl ring or 5 carbons in a heteroaryl ring. By changing the definition to the ladder definition, the claims allow a broader scope of rings which are not supported by the specification as filed. For instance, a 3 membered heterocycloalkyl ring could correspond to a ring having 2 carbon atoms and 1 oxygen atom. Similarly, a 5 membered heteroaryl ring could correspond to a ring having 1 carbon atom and 4 nitrogen atoms (i.e. tetrazole).
Examiner previously rejected the prior claim terms (e.g. C3-10 heterocycloalkyl) as being indefinite (see page 6 of office action mailed May 14, 2025); however, has reconsidered these limitations and finds them to be definite. Examiner thus recommends amending the claims to recite the former definitions (e.g. C3-C10 heterocycloalkyl, C5-C10 heteroaryl) to overcome the rejection.
Claim Rejections - 35 USC § 112b
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 9 and 24-25 are 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. [A] claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear (MPEP 2173.04). The following terms and/or phrases render the scope of the claims unclear because the specification does not provide a scope limiting definition of the phrase or term, or any direction for ascertaining the scope of the limitation indicated by the term or phrase. Accordingly, one skilled in the art could not ascertain the metes and bounds of the claimed invention.
Claim 9 depends from canceled claim 2. The metes and bounds of claim 9 are therefore unclear. Claim 9 should be amended to depend from a claim that is not canceled.
Claim 24 depends form claim 1 and recites compounds of Formula I wherein X is N and Y is CH (examples pictured below). There is insufficient antecedent basis for these limitations in the claims because the claims depend form claim 1 which requires that X is CH and Y is N.
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Claim 25 depends form claim 4 and recites compounds of Formula II wherein X is N, Y is CH, and Z is O or S (examples pictured below). There is insufficient antecedent basis for these limitations in the claims because the claims depend form claim 4 which requires that X is CH, Y is N and Z is CR9R10.
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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, 4-5, 8-9, and 14-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-8 of copending Application No. 18/155,281 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the reference application.
A non-statutory obviousness-type 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); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
Obviousness-type double patenting requires rejection of an application claim when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent, or a non-commonly owned patent but subject to a joint research agreement as set forth in 35 U.S.C. 103 (c)(2) and (3), when the issuance of a second patent would provide unjustified extension of the term of the right to exclude granted by a patent. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 58 USPQ2d 1869 (Fed. Cir. 2001); Ex parte Davis, 56 USPQ2d 1434, 1435-36 (Bd. Pat. App. & Inter. 2000).
One having ordinary skill in the art at the time of the invention would have noted that subject matter exists in both the instant invention and the copending application that is not patentably distinct from each other. It has also been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
In the present case, the reference claims are drawn to a composition comprising the compound of instant Formula (I) (see reference claim 6) and a composition comprising a compound of instant Formula (II) (see reference claim 7). The compounds of the reference claims overlap and teach the instant claims and therefore anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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January 22, 2026
/K.S.M./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624