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 .
Election/Restrictions
Applicant’s election without traverse of the species compound Vb
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as set forth in Claim 9 without traverse in the reply filed on 11/25/2025 is acknowledged.
Claims 1-5, 7 and 9-25 are currently pending.
Claims 4-5 and 7 are withdrawn from consideration as being drawn to non-elected species..
Claims 1-3 and 9-25 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 5/19/2023 is acknowledged and has been considered except where lined through.
Claim Objections:
Claim 24 is confusing in that it recites that R20a and R20b is independently:
i)-(CH2)tR19, wherein R19 is Hydrogen, a C1-C6 alkyl …, iv)-OR24, wherein R24 is C1-C6 alkyl; … vi) -C1-C6 alkyl, -OH… t is 0….”. As such, if t is 0, iv) and vi) equals -OH is duplicative of i). Appropriate corrections are required.
Claim Interpretation
Claims 1 and 9 are confusing. Both claims 1 and 9 recite “…at least one R1 is NR9R10, wherein NR9R10 is piperidinyl, piperazinyl or pyrrolidinyl, each of which is substituted by –(CH2)OR19…”. Claim 1 further defines R9 and R10. As such, it is unclear how to interpret NR9R10. For example, is the whole variable NR9R10 a piperidinyl, piperazinyl or pyrrolidinyl. Alternatively, is “N” the piperidinyl, piperazinyl or pyrrolidinyl, which is substituted with R9 and R10 or does R9 and R10 come together to form a piperidinyl, piperazinyl or pyrrolidinyl with the nitrogen to which they are bonded. For prior art purposes the examiner is going to interpret NR9R10 to be alternatives, wherein the whole variable NR9R10 a piperidinyl, piperazinyl or pyrrolidinyl, each of which is substituted by –(CH2)OR19 (Claim 12) or NR9R10 is not limited to piperidinyl, piperazinyl or pyrrolidinyl, but R9 and R10 as defined in claim 1.
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.
Claims 1-5, 7 and 9-23 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.
Regarding claim 1, claim 1 recites …”(ii) at least one R1 is NR9R10, wherein NR9R10 is piperidinyl, piperazinyl or pyrrolidinyl, each of which is substituted by –(CH2)OR19…” and further defines R9 and R10 as “…each R9 and R10 is independently alkyl, alkenyl, alkynyl… or R9 and R10 together with the nitrogen atom to which R9 and R10 are attached form a heterocyclic or heteroaromatic ring, which is unsubstituted or substituted….”. As such, the claims are confusing and indefinite in that it defines NR9R10 to be multiple variables which are restrictive in some instances, e.g. piperidinyl has to be substituted by –(CH2)OR19, or broadly wherein R9 and R10 together with the nitrogen atom to which R9 and R10 are attached form a heterocyclic or heteroaromatic ring, which is unsubstituted or substituted. For prior art purposes, the claims will be interpreted broadly.
Regarding claim 12, claim 12, which depends from claim 9, recites that at least one R1 is NR9R10, wherein NR9R10 is piperidinyl, piperazinyl, azetidinyl, pyrrolidinyl or morpholinyl…”. However, neither claim 9 or claim 1 recites that NR9R10 is azetidinyl or morpholinyl. As such, claim 12 appears to lack antecedent basis.
Regarding claim 13, claim 13, which depends from claim 12, recites “…wherein each piperidinyl, piperazinyl, pyrrolidinyl or morpholinyl is independently substituted by an oxygen substituted containing heterocyclic ring.” While the claims from which 12 depends recite piperidinyl, piperazinyl, pyrrolidinyl or morpholinyl are substituted by–(CH2)OR19, neither claim 12, 9 or 1 recites that these rings can be further substituted with an oxygen substituted containing heterocyclic ring. Accordingly, the claims are indefinite. Note: It does not appear that claim 13 is further defining R19.
Improper Markush
Claims 1-5, 7 and 9-25 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the 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 Markush grouping of claim 1 which has the generic formula (Ib)
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is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: While genus set forth in formula (Ib) appears to contain a similar backbone of a 5 membered ring bonded to a fused bicyclic ring composed of a 5 membered nitrogen containing ring and a 6 membered ring
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, the claims encompass an enormous number of compounds considering that each
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is independently a single or double bond, Y1 is C, N or O, Y2 is C or N, each Y3, Y4, Y5 and Y6 is independently CR2, N, NR2 or O or S, Z1 is C, N or O, Z2 is C, N or O and Z3 is C, N or O. As such, the genus as claimed does not share a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1-3, 15-17, 19-22 and 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Langlet et al. (Cell 2017; 171:824-835, IDS).
Langlet et al. teach a compound having the formula
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which reads on the instant claims wherein Y1 is N, Y2 is C, each Y3, Y4, Y5 and Y6 is independently CR2 , Z1 is C, Z2 is N and Z3 is N, A is a phenyl having at least one R1 which is NR9R10, R9 and R10 together with the nitrogen atom to which R9 and R10 are attached form a heterocyclic which is substituted with a methyl (page 30 of article submitted in the IDS).
Claim(s) 1-3, 15-17 and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number 2423080-92-4 (Entered 2020-06-11).
CAS Registry Number 2423080-92-4 teaches a compound having the structure
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which reads on the instant claims wherein Y1 is N, Y2 is C, each Y3, Y4, Y5 and Y6 is independently CR2 , Z1 is C, Z2 is N and Z3 is N, A is a phenyl having at least one R1 which is NR9R10, R9 and R10 together with the nitrogen atom to which R9 is hydrogen and R10 is a substituted heterocycle.
Claim(s) 1-3, 15-17, 19-22 and 24-25 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Univ. Columbia (US) et al. (WO2020/198351A1, 2020-10-01, IDS).
The applied reference has a common inventor/assignee 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.
Univ. Columbia et al. teach compounds having the following structures which read on the instant invention, specifically where NR9R10, R9 and R10 together with the nitrogen atom to which R9 is hydrogen and R10 is a substituted heterocycle or alternatively, wherein R9 and R10 are defined by the claims including, but not limited to:
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,
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,
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and
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to name a few (see Table 1).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Langlet et al. (Cell 2017; 171:824-835, IDS), as applied above to claims 1-3, 15-17, 19-22 and 24-25.
Langlet et al. teach a compound having the formula
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which reads on the instant claims wherein Y1 is N, Y2 is C, each Y3, Y4, Y5 and Y6 is independently CR2 , Z1 is C, Z2 is N and Z3 is N, A is a phenyl having at least one R1 which is NR9R10, R9 and R10 together with the nitrogen atom to which R9 and R10 are attached form a heterocyclic which is substituted with a methyl (page 30 of article submitted in the IDS). Langlet et al. further teaches that compound 10 is a non-specific inhibitor of FOXO which decreased the expression of both G6pc and Gck expression (page 832, 2nd column, lines 2-4).
Langlet et al. does not specifically teach that the hydrogen of compound 10 has been substituted with a methyl
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the hydrogen taught by Langlet with a methyl. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success of a compound having similar properties, because:
-Hydrogen and methyl are deemed obvious variants. In re Wood, 199 USPQ 137 (CCPA 1978).
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 17/598,695 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of formula I of the copending Application overlap in scope with the compound of formula (Ib) claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-CN110835333 A to Lu et al. (2020-02-05, google translation provided)
-Varnes et al. (Bioorganic & Medicinal Chemistry Letters 2016; 26(1), 197-202).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626