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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
Claims 106-110 are pending.
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.
Claims 106-110 are rejected under 35 U.S.C. 103 as being unpatentable over Veiseh WO2018067615; Takeuchi, (2021). R-group Replacement Database for Medicinal Chemistry. Future Science OA, 7(8); Kaschula, J. Med. Chem. 2002, 45, 3531−3539; Bissantz, J. Med. Chem. 2010, 53, 5061–5084 5061 and Atzrodt, Angew. Chem. Int. Ed. 2018, 57, 1758 – 1784.
Veiseh teach
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The difference between the above compound and that of claims 106-110 (see compound No.304) is the triazole heterocycle H of Veiseh is replace with substituents in the instant claims.
Substituents are routinely used in the medicinal chemistry art to arrive at alternate versions of previously known structural templates (pharmacophores).
H, alkyl, halogen, isotopes etc. are obvious variants of each other and used interchangeably, as result effective variables, in the art to optimize desired physical and biological properties.
According to Takeuchi, to optimize the biological activity of small molecules in medicinal chemistry, series of analogues are generated by introducing substituents on the core template of the small molecule lead compound. (See for more on Takeuchi)
Employing well-established ‘click chemistry. using alkyne substituted (at the terminal C of the alkyne) with routinely used groups,
in the place of the Veiseh
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one of skill in the art would arrive at the instantly pictured compounds.
it would have been within the routine practice of one of skill in the art to make the compounds of the instant formula. Similarly, making amide bonds to install the acrylate would be elementary to one of skill in the art.
Veiseh teaches the method of making the compounds as follows:
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Bissantz teaches titled
“A Medicinal Chemist’s Guide to Molecular Interactions’
for rationale underlying routine substitution of H for other groups. For specific C-halogen bond for C-H bond replacement, see page 5070 column B onto page 5071, with specific examples.
Similarly, see Kaschula Table at page 3352 for Cl substitution for H:
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(see below for more on the above Cl for H).
According to Atzrodt, in medicinal chemistry, the replacement of a hydrogen by a deuterium atom has recently received much attention as a way to alter the absorption, distribution, metabolism, and excretion (ADME) properties of drug candidates. See multiple examples in Schemes 1-10. (see below for more on Atzrodt).
The rejection is not under Claim Rejections - 35 USC § 102.
The cited references are art in the same area of endeavor.
Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Response to Remarks filed Remarks 03/13/2026.
Applicants argument with regards to Takeuchi:
Takeuchi does not cure the deficiency of Veiseh. Takeuchi relates to R group replacement in medicinal chemistry. Takeuchi, however, is completely silent towards the scaffold structure of the claimed compounds, or the benefits thereof.
Takeuchi at the minimum is ‘analogous art’.
In this regard, Applicant ignores Chiodi, (J. Med. Chem. 2023, 66, 5305−5331) and Atzrodt, Angew. Chem. Int. Ed. 2018, 57, 1758 – 1784 Review articles placed on record in the office action filed 01/29/2026. While Applicant overlooks these Review articles, because these citations were not entered in the ‘rejection statement’. That said, Applicant is reminded of the following.
Review papers are generally considered secondary research publications that sum up already existing works on a particular research topic or question and relate them to the current status of the topic.
For example, Kaschula, J. Med. Chem. 2002, 45, 3531−3539 cited in this action is found in the Chiodi.
Substituting H on the periphery of ring system of known structural core (pharmacophore) is routinely practiced in the medicinal chemistry art to arrive at alternate optimized versions of prior art compound.
H, alkyl, halogen, isotopes etc. are obvious variants of each other and are used interchangeably, as result effective variables, to optimize desired physical and biological properties. The argued upon ‘unexpected activity’ is limited to chloro substituted compounds (claim 109) The claims are not limited to chloro.
This is not hind sight analysis. Veiseh provides the template/pharmacophore. Takeuchi provides the fundamentals of the medicinal chemistry exercise of why and how. The multiple citations of Takeuchi is not presented here to avoid redundancy. Why and how of the above routine optimization is/re the subject matter of previously presented Takeuchi teaching.
With respect to the specific D replacement for H, in the above pointed out Applicant’s argument: See Atzrodt.
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 106-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11945786 further in view of Veiseh WO2018067615; Takeuchi, (2021). R-group Replacement Database for Medicinal Chemistry. Future Science OA, 7(8); Kaschula, J. Med. Chem. 2002, 45, 3531−3539; Bissantz, J. Med. Chem. 2010, 53, 5061–5084 5061 and Atzrodt, Angew. Chem. Int. Ed. 2018, 57, 1758 – 1784.
The difference in the conflicting claims is the substituents (instant claims) on the triazole rings. Replacement of H with other groups such as halogen, alkyl etc. is part of routine optimization exercise in the art.
The redundancy below is as per Examination guidelines
Veiseh teach
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The difference between the above compound and that of claims 106-110 (see compound No.304) is the triazole heterocycle H of Veiseh is replace with substituents in the instant claims.
Substituents are routinely used in the medicinal chemistry art to arrive at alternate versions of previously known structural templates (pharmacophores).
H, alkyl, halogen, isotopes etc. are obvious variants of each other and used interchangeably, as result effective variables, in the art to optimize desired physical and biological properties.
According to Takeuchi, to optimize the biological activity of small molecules in medicinal chemistry, series of analogues are generated by introducing substituents on the core template of the small molecule lead compound. (See for more on Takeuchi)
Employing well-established ‘click chemistry. using alkyne substituted (at the terminal C of the alkyne) with routinely used groups,
in the place of the Veiseh
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72
82
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Greyscale
one of skill in the art would arrive at the instantly pictured compounds.
it would have been within the routine practice of one of skill in the art to make the compounds of the instant formula. Similarly, making amide bonds to install the acrylate would be elementary to one of skill in the art.
Veiseh teaches the method of making the compounds as follows:
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Bissantz teaches titled
“A Medicinal Chemist’s Guide to Molecular Interactions’
for rationale underlying routine substitution of H for other groups. For specific C-halogen bond for C-H bond replacement, see page 5070 column B onto page 5071, with specific examples.
Similarly, see Kaschula Table at page 3352 for Cl substitution for H:
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(see below for more on the above Cl for H).
According to Atzrodt, in medicinal chemistry, the replacement of a hydrogen by a deuterium atom has recently received much attention as a way to alter the absorption, distribution, metabolism, and excretion (ADME) properties of drug candidates. See multiple examples in Schemes 1-10. (see below for more on Atzrodt).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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