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 .
Current Status
This action is responsive to the amended claims of 07/01/2026. Claims 1-3, 13-20, 25-27, and 32 are pending. Claims 4 and 8 have been canceled. Claims 25 and 32 are withdrawn. Claims 1-3, 13-20, and 26-27 have been examined on the merits.
Election/Restrictions
The amendments and arguments of 07/01/2026 have overcome the prior art rejection of record. The Markush search has been expanded to the full scope of Formula (I) (independent claim 1) and Formula (II) (independent claim 26). No prior art was retrieved (see SEARCH 6 of the attached search notes). Thus, the election of species is rendered moot and withdrawn.
The Group I claims 1-3, 13-20, and 26-27 are still subject to rejections. Thus, the restriction requirement is still in place.
Claims 25 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/25/2026.
Priority
The effective filing date is 11/30/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/01/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 07/01/2026; no new matter is found.
On Pg. 15 of the remarks, Applicant argues improper withdrawal of claims 2, 4, and 13-19. Applicant argues the originally elected species reads on such claims and thus, the claim should not have been withdrawn. Examiner notes, the Markush search was extended when no art was found for the originally elected claims. The withdrawn and examined claims were determined based on the extended, i.e., the next elected species after the first was found free of the art. However, this point is moot as the search has been fully extended, and all Group I claims are under examination.
Note, no new rejections are held against the previously withdrawn claims based on the previously presented content. Any objections and rejections are necessitated by the amendments – i.e., a degradation in the image quality of structures in the amended claims of 07/01/2026 when compared to the previously presented claims of 02/25/2026 (see below).
The objection to the specification abstract is withdrawn since the abstract now recites the general nature of the claimed compound.
The objection to claims 1, 3, 20, and 26-27 (¶11-12 of prev. action) are withdrawn since Applicant has amended in line with Examiner’s suggestions.
The objections to claim 8 are withdrawn because claim 8 is canceled.
The objection to claim 26 over grammar is withdrawn since Applicant has amended in line with Examiner’s suggestions.
Applicant has addressed the concerns expressed by Examiner over previously withdrawn claims 2, 4, and 19 (¶15 of prev. action). Claim 4 is canceled and claims 2 and 19 are amended in line with Examiner’s suggestion.
The 102(a)(2) rejection of claims 1, 3, 8, 20, 26, and 27 over FUHRMANN (WO 2022/103411, provided in IDS of 09/14/2023) is withdrawn. Applicant states FUHRMANN was commonly owned by the instant Applicant Genentech Inc. and is an exception under 102(b)(2)(C). Thus, FUHRMANN cannot be prior art.
The anticipatory, provisional nonstatutory double patenting rejection of claims 1, 3, 8, 20, and 26-27 over copending Application No. 18/195,134 is maintained for claims 1, 3, 20, and 26-27. The rejection is withdrawn for claim 8 since the claim is canceled.
Applicant argues that the compounds recited in the reference Application do not fall within the instant Formulas (I) and (II) since the Rs substituted on R1 is a 5 membered heteroaryl containing a S. Applicant argues the instant claims recite the heteroaryl “has one or more annular atoms, independently selected from N and O.” Accordingly a thiazole ring as recited in the reference compounds does not fall within the scope of the instant claims.
Examiner respectfully disagrees. As explained in the previous action (mailed 04/01/2026 – see Pg. 7 ¶18), the instant recitation of “has one or more annular atoms, independently selected from N and O” does not limit the heteroatoms of the heteroaryl to only N and O, it simply requires that at least one of the atoms in the cycle is N or O. Under the broadest reasonable interpretation (BRI), the phrase “has one or more” is not closed language (e.g., consisting of). Further, the claim does not use Markush language (i.e., “selected from the group consisting of”) to limit the heteroatoms present in the heterocycle. Thus, the recitation of “has one or more annular atoms, independently selected from N and O” only requires the heteroaryl to have at least a N or O. The other atoms present are not specified (i.e., left open to the BRI). Further, the instant claim invokes “annular atoms”, not specifically heteroatoms. The annular atoms necessarily require atoms other than N and O (e.g., at least carbon) to make a full heterocycle. Each of these considerations leaves the annular and heteroatoms, beyond at least one N or O, open to the broadest reasonable interpretation (e.g., C, S, etc.). Thus, the rejection is maintained.
Double Patenting – Maintained
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, 3, 20, and 26-27 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claim 1, 36-38, and 40-42 of copending Application No. 18/195,134 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 36 and 37 recite species of formula (I) (ref. claim 1) including
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and
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and stereoisomers thereof
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and
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. These species read on instant Formula (I) II) and Formula (II) II); wherein L2-R2 is cyclopropyl, L1 is C1 alkylene (-CH-) substituted with one Re, Re is C1 alkyl (Me), and R1 is C6 aryl substituted with one or two Rs wherein Rs is 5 membered heteroaryl which has one annular atom selected from N and halo (Cl). Reference claim 38 is drawn to a pharmaceutical composition comprising said species and one or more pharmaceutically acceptable excipients. Reference claims 40-42 are drawn to methods of use thereof. Thus, the reference claims are drawn to species of the instant claims and therefore anticipate instant claims 1, 3, 20, and 26-27.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Amendment – Necessitated by Amendment
Claim Objections
Claims 13-18 and 26-27 are objected to because of the following informalities: the images of the structures provided in claims 13-18 and 26 have visibly degraded in resolution compared to the previously presented claims of 02/25/2026. The pixelation/low resolution makes the structures difficult to read, but ultimately, they are readable. However, it is appreciated if a higher resolution version can be filed to replace the current images (to avoid any further resolution loss). Dependent claim 27 is similarly objected to since it depends from claim 26. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19: the structures in the claim are of low resolution (compared to the claims of 02/25/2026) making the atoms/bonds impossible to interpret with confidence. For example,
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based on parent claim 1, these moieties should be triazoles; however, the bonds and atoms are unclear and determination cannot be predicated on an assumption. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: please provide higher resolution images of the structures in claim 19. All structures recited in claim 19 are affected by the degraded resolution.
Conclusion
Claims 1, 3, 19-20, and 26-27 are rejected.
Claims 13-18 are objected to.
Claim 2 is objected to as dependent from a rejected claim (claim 1).
The close art is represented by: FUHRMANN (WO 2022/103411, provided in IDS of 09/14/2023). FUHRMANN teaches 3 compounds which fall under Formula (I) II) and Formula (II) II) of the instant claims; e.g., Compound 24
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(Pg. 180 ¶384; PD Pg. 62 specification) wherein L2-R2 is cyclopropyl, L1 is C1 alkylene (-CH2-), and R1 is C6 aryl substituted with one Rs, Rs is 5 membered heteroaryl which has one annular atom selected from N.
However, FUHRMANN is commonly owned and is an exception under 102(b)(2)(C). Thus, it cannot be prior art, only close art.
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 SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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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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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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