DETAILED ACTION
The amendment submitted on February 6, 2026 has been entered. Claims 32-45 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obvious-ness 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) resolv-ing the level of ordinary skill in the pertinent art; and (4) considering objective evidence present in the application indicating obviousness or nonobviousness. See MPEP1 2141 et seq.
Claims 32-39 remain rejected and new claims 40-45 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/036835 A1 by Upasani et al.
Upasani (cited in the prior action) discloses pharmaceutical compositions (pp. 105-10) of compounds having the following generic chemical structure (p. 79):
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485
701
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,
wherein “R3a is … unsubstituted alkyl … R2 is hydrogen … R11a is hydrogen and R11b is hydrogen … ········ represents a single bond … [or] … a double bond … R6a and R6b are both hydrogen” (para. 00252). For the stereocenters that are not specifically indicated in Formula I-y, the reference clearly contemplates all these enantiomers and diastereomers (para. 0029). With regard to the R3a substituent as an “unsubstituted alkyl” group, the reference provides as examples both methyl and ethyl groups (para. 0030 and 0032), i.e., the same substituents found in all of the compounds of the instant claims. The “Z” substituent is
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186
289
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(para. 00189), wherein L3 is
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182
355
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(para. 00224), Y is –O– (p. 5; see also para. 00230), RZ5 is hydrogen (para. 00192), and RZ6 is an “unsubstituted C1-6alkyl” group (para. 00204). The reference (para. 00204) further explains that the RZ6 substituent is, for example, a “n-butyl (C4)” group, which suggests the first compound in claims 32-33 and 35. Alternatively, the RZ6 substituent is an “ethyl (C2)” group, which suggests the first compound in claim 34. Other such compounds within the scope of the instant claims would have been apparent to the skilled artisan.
Although Upasani does not specifically disclose any of the claimed compounds, the exam-iner nevertheless concludes that subject matter within the scope of the claims would have been prima facie obvious to one of ordinary scope as of the effective filing date when the teachings of the reference are considered as a whole. As outlined in the preceding paragraph, it appears that one would simply follow the instructions in Upasani and reduce its teachings to practice, using nothing more than routine experimentation, and thereby arrive at the compounds of claims 32-35.
With respect to new claims 40-45, the reference discloses pharmaceutically acceptable salts at para. 00102. One would have viewed the subject matter of the new claims as being a matter of reduction to practice of the generic teachings of the cited reference by nothing more than routine experimentation.
Response to Arguments
Applicant argues that “[i]n order to arrive at the species of the substitute claims, the ordinary skilled worker would have had to make multiple selections from lists of substituents,” but “nothing in Upasani would have motivated the ordinary skilled worker to make these selec-tions from multiple lists to arrive at the compounds claimed in the instant claims any more so than any other compound arising from different combinations of selections from the panoply of recited substituent groups for Formula (I-y) of Upasani. Moreover, Upasani does not specifically teach or suggest any of the combinations of substituents that characterize the instantly claimed species. Nor does Upasani disclose any specific compounds (and the Examiner does not point to any specific compounds), comprising a combination of substituents that characterizes any of the species recited in the instant claims.” See applicant’s Remarks, submitted February 6, 2026, at pp. 16-18.
But applicant’s specification makes qualitatively the same description of the claimed compounds. See applicant’s own specification at pp. 2-3 and 23-42. Applicant’s description of their invention requires one of skill in the art to make various selections from a variety of different lists of substituents in order to arrive at specific chemical compounds. It is unclear why this manner of description is acceptable for applicant, yet improper in the prior art. In any case, applicant’s position, taken to the logical extreme, is that Upasani cannot be prior art because it essentially contains too much information, or as applicant describes it, Upasani requires “differ-ent combinations of selections from the panoply of recited substituent groups.” Remarks at p. 18. Surely it cannot be the law that Upasani is not prior art simply because it contains too much information. Applicant’s arguments have been fully considered but are not persuasive. The examiner maintains that the instant claims would have been viewed as being prima facie obvious over Upasani, and the rejection is accordingly maintained.
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 possi-ble harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined appli-cation 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 Good-man, 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 applica-tions 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 accompa-nied 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(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 that 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/terminaldisclaimer.
Claims 32-39 remain provisionally rejected and new claims 40-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 16-19, 22, 26-29, 36, 38, and 42 of copending Application No. 18/893,387. Although the claims at issue are not identical, they are not patentably distinct from each other. The copending ’387 Application is equivalent to WO 2013/036835 A1 by Upasani et al., discussed above. The obviousness rationale explained in detail above applies likewise to the claims of the ‘387 Appli-cation, mutatis mutandis. See, e.g., claim 1 submitted on May 1, 2025 in the ‘387 Application. By selecting the same substituents in substantially the same manner outlined above, one arrives at the subject matter of the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented.
Response to Arguments
Applicant present similar arguments as discussed above. Briefly, applicant argues that “[n]othing in the claims of the ‘387 Application would have led the ordinary skilled worker to make selections from the multiple lists of substituents recited for the compounds recited in claim 1, so as to obtain the specific compounds of the instant claims with any reasonable expec-tation success. Indeed, the general formula recited in claim 1 of the '387 Application encom-passes a larger number of compounds than does Formula (I-y) of Upasani. As such, the ordinary skilled worker would have had to make a selection from an even larger number of different lists of substituents.” See applicant’s Remarks at pp. 18-19. This argument is not persuasive for substantially the same reasons discussed above. Applicant’s arguments have been fully consid-ered, but are not persuasive. This provisional rejection is therefore maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 advi-sory 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 Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Exam-iner 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
April 2, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]