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 1-30, 32-43, and 48 are pending.
Claims 6, 17, 24-26, 30, 32-43, and 48 are withdrawn (see election/restriction below).
Claim 48 is new.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/GB2021/051396, filed 06/04/2021; and further claims priority to foreign Patent Application numbers GB2103704.9 and GB2008526.2, filed on 03/17/2021 and 06/05/2020, respectively.
Information Disclosure Statement
All references from IDS(s) received 11/16/2022, 10/03/2023, 12/16/2024, 5/21/2025, and 7/7/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 10/27/2025 is acknowledged.
Claims 30 and 32-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medicament/composition and method of use, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/2025.
Applicant’s election of the compound below without traverse in the reply filed on 10/27/2025 is acknowledged.
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Claims 6, 17, 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as not reading on the elected species.
No anticipatory art was found of the elected specie, so the Examiner expanded her scope pursuant to MPEP 803. The expanded species are described in the 103 rejection. See 103 analysis below. No 103 rejection could be made over the elected specie and the elected specie would be considered allowable.
Claim 48 is withdrawn as not reading on the expanded specie, but would be considered allowable in independent form.
Claims 1-5, 7-16, 18-23, and 27-29 will be examined upon their merits.
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.
Claims 1-5, 7-16, 18-23, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada, A. et al. (US20040048904A1; “Yamada”).
This rejection applies to the expanded specie, compound 10, see below.
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Yamada teaches an overlapping structure with the expanded specie, 2-(4-Fluorophenylcarbamoyl)-1,2,3,4-tetrahydroisoquinoline (Page 5, Example 3; Structure seen below drawn by examiner for convenience).
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Yamada fails to teach a structural example where instant R3 is CF3 and instant R2 is Cl. However, Yamada does teach in the genus structure that the aryl ring may be substituted with any amount of halogen group or alkyl group, since a singular substitution was not specified (Claim 1). Therefore, it would be obvious to extract the structure taught by Yamada and substitute different halogens on the -R3 phenyl ring as there is only a finite list of possible structures.
Yamada teaches the compounds for use in diseases but fails to teach the compounds as explicitly modulators of gpr65. However, the MPEP states that compounds with structural similarity are expected to have similar properties. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In rePapesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In reDillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). See MPEP 2144.09(I).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the structure taught by Yamada and substitute different halogens on the -R3 phenyl ring, since Yamada does not specify the amount of substitutions allowed and there is only a finite list of possible structures. Therefore, claims 1-5, 7-16, 18-23, and 27-29 would be obvious to a person skilled in the art at the time.
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 1-5, 7-16, 18-23, and 27-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, 11, 13, 16-21, 24-25, 27-28, 30, 32-33, 37-39, 43-44, and 46 of copending Application No. 18/849,834.
Although the claims of the instant application are not exactly the same as the ‘834 application, the applications have overlapping genus structures. See the genus structure presented in the ‘834 application below:
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The ‘834 application claims recite where ring A can be a 5-6 membered aromatic or heteroaromatic ring, Y and Z can be -CH, and Ring B can be a monocyclic heteroaromatic group substituted with at least one halogen. Claim 9 of the ‘834 application recites the same exact limitations as claim 7 of the instant application. Compounds of the ‘834 application would fall under the genus structure of the instant application and vice versa.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-5, 7-16, 18-23, and 27-29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621