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 .
Status of the Claims
Claims 1, 2, 4-6, and 14 are pending.
Claims 1, 2, 5, and 6 are currently amended.
Claims 3 and 15-17 are currently cancelled.
Claims 7-13 were previously withdrawn.
Election/Restrictions
As stated on pages 2-4 in the previous office action dated 17 September 2025 (hereinafter POA), the Group I claims 1-6 and 14-17 species election of instant formula (I) compound 77, see below, drawn to claims 1, 2, 4-6, and 14-17 appears to be free of prior art; therefore, the search and examination was extended to the non-elected species or group of species of claim 1 general formula (IA) that fall within the scope of a proper Markush grouping that include the elected species of instant compound 77 of Group I, see MPEP 803.02 III.C.2. As a result, claims 1, 2, 4-6, and 14-17 were examined on the merits, and claim 3 drawn to formula (II) and the Group II claims 7-13 were withdrawn in the POA.
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Newly amended claim 5 to independent form is directed to inventions that are independent or distinct from the invention originally claimed for the following reasons:
Newly amended claim 5 is directed to compounds of differing species of claim 1 formula (IA) without at least one R1 as ethynyl, such as compound 2, without Ring A substituted, such as compound 45, etc., and compounds of formula (II), such as compound 75. Newly amended claim 5 may also contain compounds that detail variables that are not detailed in claim 1.
Since applicant has received an action on the merits for the originally presented elected without traverse inventive species of claim 1 general formula (IA) that fall within the scope of a proper Markush grouping that include the elected species of instant compound 77 of Group I for prosecution on the merits, and formula (IA) compound 77 was deemed free of the prior art, where examination was then extended to additional species of formula (IA),- claims 5 and 6 are herein withdrawn from consideration as being directed to a non-elected invention and non-elected species, see 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Accordingly, the species of claims 1, 2, 4, and 14 of general formula (IA) that fall within the scope of a proper Markush grouping that include the elected species of instant compound 77 of Group I are herein examined on the merits, claims 5 and 6 are herein withdrawn, and claims 7-13 remain withdrawn.
Response to Amendments
Applicant’s amendments filed 11 December 2025 are acknowledged.
Claim Objections
Applicant’s appear to have filed a non-compliant amendment, see MPEP 714 II.F. Claim 14 has been amended without the proper mark-ups, see MPEP 714 II.C. Applicant’s non-compliant amendment to claim 14 removing the multiple claim dependency is sufficient to overcome the objection of the claim. The objection is withdrawn.
Applicant’s current cancellation of claims 15-17 is sufficient to overcome the objection of the claims. The objections are withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s cancellation of claims 3 and 15-17 is sufficient to overcome the rejections of claims 15-17 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. All of the rejections of claims 3 and 15-17 under 35 U.S.C. 112(b) are withdrawn.
Applicant’s amendment to claim 1 regarding the Ring A substituent variables is not sufficient to overcome the rejection of claims 1, 2, 4-6, and 14 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The rejection is maintained, modified, and a new ground(s) of rejection is/are provided below.
Applicant’s amendment to claim 1 identifying all of the wavy line attachments of the Ring A substituent structures is sufficient to overcome the rejection of claims 1, 2, 4-6, and 14 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The rejection is withdrawn.
Applicant’s amendment to claims 1 and 2 removing the parentheticals is sufficient to overcome the rejection of claims 1, 2, 4-6, and 14 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The rejection is withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s cancellation of claims 15-17 is sufficient to overcome the rejections of claims 15-17 under 35 U.S.C. 102 as being anticipated. All of the rejections of claims 15-17 under 35 U.S.C. 102 are withdrawn.
Applicant’s amendment to claim 1 where at least one R1 is ethynyl is not taught by Lairson and is sufficient to overcome the rejection of claims 1, 2, 4, and 14 under 35 U.S.C. 102(a)(2) as being anticipated by Lairson et al. (WO2019165032, filed 21 February 2019, hereinafter Lairson). Due to the statement of common ownership, see the response to arguments below, and the amendment to claim 1 where at least one R1 is ethynyl not taught by Lairson, the rejection is withdrawn and a new ground(s) of rejection is/are provided below.
Applicant’s amendment to claim 1 where at least one R1 is ethynyl is not taught by Riordan and is sufficient to overcome the rejection of claims 1, 2, and 4 under 35 U.S.C. 102(a)(1) as being anticipated by Riordan et al. (US5756524, patented 26 May 1998, hereinafter Riordan). Due to the amendment to claim 1 where at least one R1 is ethynyl not taught by Riordan, the rejection is withdrawn and a new ground(s) of rejection is/are provided below.
Claim Rejections - 35 USC § 103
Applicant’s amendment to claim 1 where at least one R1 is ethynyl is not taught by Lairson and is not sufficient to overcome the rejection of claims 5 and 6 under 35 U.S.C. 103 as being 35 U.S.C. 103 as being unpatentable over Lairson et al. (WO2019165032, filed 21 February 2019, hereinafter Lairson). Due to the statement of common ownership, see the response to arguments below, the amendment to claim 1 where at least one R1 is ethynyl not taught by Lairson, and the current withdrawal of claims 5 and 6, the rejection is withdrawn.
Applicant’s amendment to claim 1 where at least one R1 is ethynyl is not taught by Riordan and is sufficient to overcome the rejection of claim 14 under 35 U.S.C. 103 as being unpatentable over Riordan et al. (US5756524, patented 26 May 1998, hereinafter Riordan) in view of Banerjee et al. (WO2018234807, hereinafter Banerjee). Due to the amendment to claim 1 where at least one R1 is ethynyl not taught by Riordan the rejection is withdrawn and a new ground(s) of rejection is/are provided below.
Response to Arguments
Applicant’s arguments filed 11 December 2025 have been fully considered and are rendered moot.
Applicant’s argue that Lairson, Riordan, and Banerjee are not prior art or do not disclose the limitations as recited in amended claim 1. These arguments have been considered; however, the arguments are rendered moot for the reasons set forth in the new grounds of rejection below and the response to arguments below.
Applicant’s arguments with respect to Lairson, Riordan, and Banerjee throughout the remarks filed on 11 December 2025 have been considered but are moot because the new ground of rejection does not rely on Lairson, Riordan, and Banerjee applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s 35 U.S.C. § 102(b)(2)(c) Response
Applicant’s statement on page 26 of the remarks filed on 11 December 2025 that “[p]ursuant to 35 U.S.C. § 102(b)(2)(c), Applicant avers that as of the effective filing date of the present invention, the subject matter of the present claims and the subject matter disclosed by Lairson were owned by, and subject to obligation of assignment to, the same person, namely The Scripps Research Institute”, is sufficient to overcome the rejections of:
Claims 1, 2, 4, and 14-17 under 35 U.S.C. 102(a)(2) as being anticipated by Lairson et al. (WO2019165032, filed 21 February 2019, hereinafter Lairson); and,
Claims 5 and 6 under 35 U.S.C. 103 as being obvious over Lairson et al. (WO2019165032, filed 21 February 2019, hereinafter Lairson).
Due to applicant’s clear and conspicuous statement that the claimed invention of the application under examination and the subject matter disclosed in WO2019165032 to Lairson et al. applied as prior art were owned by the same person or subject to an obligation of assignment to the same person, namely The Scripps Research Institute, not later than the effective filing date of the claimed invention the rejections are withdrawn, see MPEP 2154.02(c).
New, Maintained, and Modified Rejections Based on Amendments to the Claims in the reply filed on 11 December 2025
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites “according to any one of claim 1”, which appears to include typographical mistakes. Claim 14 is interpreted to state “according to
Appropriate correction is required.
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.
Claims 1, 2, 4, and 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
If the language of the claim is such that a person of ordinary skill in the art could
not interpret the metes and bounds of the claim so as to understand how to avoid
infringement, a rejection of the claim under 35 USC 112(b) is appropriate, see MPEP
2173.02.
As stated in the POA, “Claim 1 includes a listing of shown structures as potential variables for Ring A. It is unclear as to whether or not the shown structures are attached to ring A.”
Regarding claim 1, the description for Ring A remains unclear. Newly amended claim 1 states the Ring A limitations of “substituted with 1, 2, or 3 groups independently selected from the group consisting of NH2, NH-benzyl, wherein the benzyl is unsubstituted or is substituted with methoxyl, cyano, alkylnitrile, haloalkyl, hydroxymethyl, aminomethyl, aminopropyl, carboxamido, alkoxy,” shown structures, and last shown structure, which all refer to the substitution of the NH-benzyl and not Ring A.
In an examiner-initiated interview on 04 March 2026, the interview summary is to be mailed approximately 09 March 2026, the attorney for the applicant explained that only methoxy is a substitute on the NH-benzyl ring and the rest of the limitations starting with cyano are individually each substitutions of the Ring A “substituted with 1, 2, or 3 groups independently selected from the group consisting of …”. The claim limitation is interpreted to state, “substituted with 1, 2, or 3 groups independently selected from the group consisting of NH2, NH-benzyl optionally substituted with methoxyl,
Claims 2, 4, and 14 depend from base claim 1 and are included in this rejection as they do not correct the informalities identified in base claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 4, the claim states Ring A “can be unsubstituted or substituted”. Claim 4 depends from claim 1. Newly amended claim 1 states Ring A must be substituted; therefore, claim 4 broadens claim 1 failing to further limit the subject matter of the claim upon which it depends and fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
In the Spirit of Compact Prosecution
While the examiner has attempted to identify all objections and clarity issues amongst the claims, applicant is advised that some objections and clarity issues may still remain. Going forward, the examiner respectfully requests applicant to perform a detailed review of the claims regarding clarity, grammar, antecedent basis, word spacing, and spelling issues.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, and 14 are newly rejected under 35 U.S.C. 103 as being obvious over Green et al. (WO2018183145, published 04 October 2018, hereinafter Green) in view of Cramp et al. (EP0053011, published 02 June 1982, hereinafter Cramp).
Green is in the known prior art field of nicotinamide compounds, see Paras. [0005]-[0009];[0243]-[0244].
Regarding instant application claim 1, Green teaches the nicotinamide compound x88, where X is -C(R1)=C(R1)- and each R1 is H; R1 is cyano; the next adjacent R1 is H; R2 is a 6 membered heterocycle; R is absent; and, Ring A is a 6 membered heterocycle comprising 1 N atom substituted with 1 alkoxy, see below and Paras. [0243]-[0244],
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, meeting formula (IA) variables X, R2, one R1, and Ring A in instant application claim 1.
Green does not specifically emphasize together in one specifically synthesized and/or one specifically shown chemical structure the claim 1 limitations of at least one R1 is ethynyl.
Green differs from the instantly claimed formula (IA) by teaching compound x88 has at least one R1 as cyano instead of the instantly claimed ethynyl, i.e., to replace the triple bond nitrogen atom with a carbon atom. Green teaches compound x88 which is a structurally similar analog and/or homolog to the compound of formula (IA), see above, and ethynyl may be a substituent within the compounds, see Para. [0030]. Compound x88 modified to replace cyano with ethynyl leads to a structurally similar analog and/or homolog of instantly claimed formula (IA).
Since analogs, homologs, and/or compounds having very close structural similarities and similar utilities, are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties, see MPEP 2144.08-2144.09, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified compound x88 of Green to select the desired triple bond moiety, such as ethynyl instead of cyano, with a reasonable predictability of success for the purpose of synthesizing the optimal 2-methoxynicotinamide compound with the optimal activity, see Paras. [0003];[0023];[0030];[0088];[0243]-[0244], meeting formula (IA) in instant application claim 1.
By applying “routine optimization” and “predictable results” to select the optimal triple bond moiety, such as ethynyl instead of cyano, one of ordinary skill in the art would have been motivated to make these modifications because Green provides a finite number of identified, predictable solutions. A person of ordinary skill in the art has good reason to produce a compound structurally similar to Compound x88 by pursuing the known options within their technical grasp for the benefit of obtaining a structurally similar nicotinamide compound with a ethynyl triple bond moiety in order to synthesize the optimal 2-methoxynicotinamide compound with the optimal activity, see Paras. [0003];[0023];[0030];[0088];[0243]-[0244]; MPEP 2143 and 2144.08-2144.09.
Regarding instant application claim 4, Green teaches Ring A is a 6 membered heterocycle comprising 1 N atom aka pyridine substituted with 1 alkoxy, see above and Paras. [0243]-[0244], meeting the specific Ring A in instant application claim 4.
Regarding instant application claim 14, Green teaches “a pharmaceutical composition which includes a compound of Formula 1 or a pharmaceutically acceptable salt thereof, or any one of the compounds or pharmaceutically acceptable salts” “and a pharmaceutically acceptable excipient”, see Paras. [0007];[0113], meeting the composition, salt thereof, and carrier in instant application claim 14.
As stated above, Green does not specifically emphasize together in one specifically synthesized and/or one specifically shown chemical structure the claim 1 limitations of at least one R1 is ethynyl.
Cramp is in the known prior art field of nicotinamide compounds, see Pg. 1, Ln. 5-Pg. 2, Ln. 22; Pg. 45, Ln. 20-Pg. 46, Ln. 3.
Regarding instant application claim 1, Cramp teaches a similar nicotinamide compound (VI), where X is -C(R1)=C(R1)- and each R1 is H, an additional R1 is R6, where “R6 represents a hydrogen, fluorine or chlorine atom or a cyano or ethynyl (CH≡C-) group”; and, Ring A is a 6 membered heterocycle comprising 1 N atom and is substituted, see below and Pg. 1, Ln. 5-Pg. 2, Ln. 22; Pg. 5, Compound 8; Pg. 45, Ln. 20-Pg. 46, Ln. 3,
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, meeting the formula (IA) R1 position as a cyano or ethynyl group in instant application claim 1.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Green to use a triple bond moiety, such as ethynyl instead of cyano, see MPEP 2144.08-2144.09 and as taught by Cramp with a reasonable predictability of success for the purpose of obtaining a structurally similar nicotinamide compound with an ethynyl triple bond moiety in order to synthesize the optimal nicotinamide compound with the optimal activity, see Cramp, Pg. 1, Ln. 5-Pg. 2, Ln. 22; Pg. 5, Compound 8; Pg. 8, Lns. 1-14; Pg. 45, Ln. 20-Pg. 46, Ln. 3; MPEP 2143 and 2144.08-2144.09.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Green and Cramp nicotinamide compounds, a person of ordinary skill in the art has good reason to modify Green by relying upon Cramp before the effective filing date of the claimed invention for knowledge generally available within the nicotinamide compound art regarding the optimal triple bond moiety group of cyano or ethynyl, see MPEP 2143 B & G, 2141, and 2144.08-2144.09, for the benefit of obtaining a structurally similar nicotinamide compound with an ethynyl triple bond moiety in order to synthesize the optimal nicotinamide compound with the optimal activity, see Cramp, Pg. 1, Ln. 5-Pg. 2, Ln. 22; Pg. 5, Compound 8; Pg. 8, Lns. 1-14; Pg. 45, Ln. 20-Pg. 46, Ln. 3; MPEP 2143 and 2144.08-2144.09.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as the triple bond moiety group of cyano or ethynyl, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Free of Prior Art
Regarding instant application claim 2, the claim appears to be free of prior art if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action.
The following is a statement of reasons as to why the claim is free of prior art:
Green et al. (WO2018183145, published 04 October 2018, hereinafter Green) teach compound x88 which is similar to the formula (IA) compound of claim 2, see below and Paras. [0243]-[0244],
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.
Green does not teach instant application formula (IA) is of formula (I) where R2 is -COOR as detailed in instant application claim 2.
Conclusion
No claims are allowed.
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 Y. Lynnette Kelly-O'Neill whose telephone number is (571)270-3456. The examiner can normally be reached Monday-Thursday, 8 a.m. - 6 p.m., EST, with Flex Time.
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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699