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 1 July, 2024, is a national stage application of PCT/US2023/010228, filed 5 January, 2023, which claims prior benefit of application PRO 63/296,811, filed 5 January, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1 July, 2024 is acknowledged and has been considered.
Election/Restrictions
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Applicant’s election without traverse of Group I, directed to compounds and compositions of Formula I, and to Compound 127, shown to the right, as the elected Species, in the reply filed on 16 September, 2026 is acknowledged.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 16 September, 2026, in the matter of Application N° 18/726,007. Said documents have been entered on the record.
Claims 1-2, 6, 15, 21, 24, 35, 50-51, 54-55, 61-62, 68-70, 73-75, 77, 79, 81, 84-85, 89, 91-93, 96, 98-99, 101, 103-104, and 113-114 were previously presented. Claims 74-75, 77, 79, 81, 84-85, 89, 91, 98-99, 101, 103-104 and 113-114 are withdrawn by Applicant.
Claims 6, 50, 55 and 96 are also withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Thus, Claims 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, 73 and 92-93 represent all claims currently under consideration.
Claim Rejections - 35 USC § 112
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 73 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 73 is incomplete in itself because it incorporates subject matter from the specification (“…the compounds shown in Table 1”). 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).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Examiner notes: Consistent with Applicant’s election, examination has been directed to the elected species having a 1,5-naphthpyridine core with both linker moieties absent, as reflected in the prior-art rejections below. No determination of patentability is made herein as to nonelected species encompassed by Formula I.
Claims 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, 73, and 92-93 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moreau et al. (WO 2022/006550 A1, cited in IDS, effective filing date 2 July, 2020), hereinafter Moreau.
The applied reference has a common applicant and overlapping inventors with the instant application. 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. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Regarding Claims 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, and 73, Moreau expressly teaches the synthesis of the elected species, Compound 127 (‘550, Pg. 310, Example 32).
Regarding Claim 92, Moreau teaches compounds of Formula I alter a target nucleic acid (‘550, Pg. 3, Para 3).
Regarding Claim 93, Moreau teaches pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt, solvate, hydrate, tautomer, or stereoisomer thereof, and optionally a pharmaceutically acceptable excipient (‘550, Pg. 3, Para 2).
As such, Claims 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, 73, and 92-93 are anticipated by Moreau.
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Claims 1-2, 15, 61-62 and 92 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armstrong et al. (WO 2010/088177 A1), hereinafter Armstrong.
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Regarding Claims 1-2, 15, 61-62, Armstrong teaches 1-{4-[3-phenyl-6-(1H-pyrazol-4-yl)-1,5-naphthyridin-2-yl]phenyl}Cyclobutanamine (‘177, Pg 177, Scheme 79, Compound 79-9), shown top right, which is fully encompassed by instant Formula I (as in instant Claim 1), shown bottom right, wherein A is
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(as in instant Claims 2 and 15), L1 and L2 are each independently absent, m is 0, n is 1, R3 is phenyl, X is CR6 where R6 is H, Y is N, Z is N, (as in instant Claims 61-62) and B is phenyl, substituted with R1 which is a cycloalkyl, which is substituted with R7 which is NRARB, where RA and RB are each independently H.
Regarding Claim 92, Armstrong teaches a pharmaceutical composition comprising the compound and an excipient (‘177, Pg 49, Lines 19-21).
As such, Claims 1-2, 15, 61-62 and 92 are anticipated by Armstrong.
Claims 1-2, 21, 51, 54, and 61-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheinkman et al. (“Naphthyridines in hetarylation”, ISSN/ISBN 04538234, 1986), hereinafter Sheinkman.
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Sheinkman teaches Compound XI (1986, Pg 4), shown top right, which is fully encompassed by instant Formula I (as in instant Claim 1), shown bottom right, wherein A and B are each a nitrogen-containing bicyclic heteroaryl (as in instant Claims 2 and 21), L1 and L2 are each independently absent, m and n are each independently 0 (as in instant Claim 54), X is CR6 where R6 is H (as in instant Claim 51), Y is N, and Z is N, (as in instant Claims 61-62).
As such, Claims 1-2, 21, 51, 54, and 61-62 are anticipated by Sheinkman.
Claims 1-2, 21, 51, 54, and 61-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh and Thummel (Inorganic Chemistry, Vol. 48, No. 14, 2009).
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Singh and Thummel teach Compound 11 (2009, Pg 6460), shown top right, which is fully encompassed by instant Formula I (as in instant Claim 1), shown bottom right, wherein A and B are each a
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nitrogen-containing monocyclic heteroaryl (as in instant Claims 2 and 21), L1 and L2 are each independently absent, m and n are each independently 0 (as in instant Claim 54), X is CR6 where R6 is H (as in instant Claim 51), Y is N, and Z is N, (as in instant Claims 61-62).
As such, Claims 1-2, 21, 51, 54, and 61-62 are anticipated by Singh and Thummel.
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 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, 73 and 92-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4, 6, 8, 10, 13, 15, 19, 22, 24-25, 28, 31, 35, 37, 45-46, 54, 56, 59-61, 63, 65, 68, and 91 of copending Application No. 18/014,059 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed genera substantially overlap, including hundreds of overlapping specifically claimed species (for example, the instantly elected species Compound 127 is claimed in both copending applications).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, 73 and 92-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2, 6, 15, 21, 24, 35, 44, 46, 48, 52, 54, 105-106 and 109 of copending Application No. 18/726,008 (reference application).
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Instant Formula I
‘008 Formula I
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed compounds differ principally in the positional arrangement of a heteroatom within the otherwise corresponding bicyclic core, and such closely related structural variations would have been obvious to one of ordinary skill in the art with a reasonable expectation of similar properties. See MPEP §2144.09.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 15, 21, 24, 35, 51, 54, 61-62, 68-70, 73 and 92-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-71, 74, and 79-84 of copending Application No. 19/492,989 (reference application).
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Instant Formula I
‘989 Formula I
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed compounds differ principally in the positional attachment of the linker-containing substituent to the bicyclic core. Such positional isomers are closely structurally related and would have been expected to possess similar properties. See MPEP §2144.09(II). “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
