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 with traverse of Group 1, claims 1, 2, 6, 8, 11, 20, 21, 25, 32, 35, 36, 43, and 46 drawn to product in the reply filed on 03/16/2026 is acknowledged. The traversal is on the ground(s) that the compound in the art cited, do not fall within the scope of claim 1. This is not found persuasive because as explained in the previous action the invariable moiety in the formulae of claims do not make a contribution over the prior art (see below) cited. Further Applicant is not responsive to the citations with regards to search burden.
Claims 47, 48, 55, 57, 62-64 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/16/2026.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1, 2, 6, 8, 11, 20, 21, 25, 32, 35, 36, 43, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan, European Journal of Medicinal Chemistry (2018), 154, 233-252 and Ojima, WO2017156354.
Yan teach, Table at page 241
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Ojima also teach
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More specifically Ojima teaches substructure formulae of the above formula at claim 10 page 15, and also specific species at pages 15-17, 86-89.
The Difference:
While the core structure of the above Ojima formula, that is structure without the multiple R groups and of Yan and the instant claims are the same, Ojima and Yan do not teach the compounds of the instant formula, because as recited in the claims, the multiple provisos in the instant claims exclude specific selective combination the R groups disclosed in Yan and Ojima. The key word here is ‘combination’ (more on this later with an example). These provisos are recited with ‘other than’ claim language to avoid anticipatory rejections of claims. The position taken by the Examiner is that the compounds of instant claims including that of species claim 43 represent ‘selective combination’ (more on this later with an example) of R group substituent combinations. Substituents such as the R groups recited and exemplified in the cited references and in the instant claims are routinely used to decorate core templates of biologically active compounds to optimize desired physical and chemical properties. The limitations of dependent claims are further selection of combination of R group possibilities. The first word ‘SAR’ in the title of cited Yan means ‘structure-activity-relationship’, the elementary medicinal chemistry principle illustrated in the last four columns of Yan Table. The actual values in these columns are irrelevant since the examined claims are drawn to products. It is acknowledged that Yan and Ojima are focused on the antinociceptive activity of the compounds and Yan and Ojima are silent with respect any and all inherent property of the compounds. Even though the elected claims are drawn to product, disclosure throughout the specification are considered including the intended use of the compounds. That said the following Examination guidelines is relevant in this context:
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
Provisos and selective combination:.
Consider the elected species (Remarks 03/16/2026 page 2) that is included in claims and the Ojima compound shown below:
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Elected species Ojima at page 87 claim 37
The difference is methoxy (OMe) group in the compound for which protection is sought.
This group OMe explicitly is included in other exemplified species (plural) in the instant claims (see claim numbered pages 16-17) and in Ojima claims (numbered pages 87-88) with other combinations of R possibilities. This is an example of deliberate exclusion of otherwise same prior art compound structure to avoid rejection under 35 USC § 102.
As such the position taken is that the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Accordingly, the claims do not appear to recite an unobvious distinction over the prior art. 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.
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.
Claim(s) 1, 2, 6, 8, 11, 20, 21, 25, 32, 35, 36, 43, and 46 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10968163. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
The formula of 10968163 falls under the scope of the claim 1 of instant case in a species (10968163) and genus relationship. With core invariable moiety being the same in both cases, the difference is the combination of various R groups decorating the core template.
Instant claim
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(numbered page 2) and also at page 17
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(of instant dependent claim) overlap with
10968163 base claim 1
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Claim(s) 1, 2, 6, 8, 11, 20, 21, 25, 32, 35, 36, 43, and 46 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11026910 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
The formula of 11026910 falls under the scope of the claim 1 of instant case in a species (11026910 ) and genus relationship. With core invariable moiety being the same in both cases, the difference is the combination of various R groups decorating the core template.
The language ‘enantiomerically enriched’ compounds of claim 1 of 11026910
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falls under the scope of the racemate of instant claim 1 formula.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32
(2010) 324–330.
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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