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 .
DETAILED ACTION
Status of the Claims
Claims 1-4, 7-9, 15-16, 20-21, 24, 27, 29, 31-32, 34, 36-37, 39, 41-43, 51, and 54-67 are pending and are examined on their merits.
35 U.S.C. § 101 Rejections Overcome by Argument
Applicant’s arguments in the response filed on March 5th 2026 are acknowledged. Applicant argues that the compounds of claim 1 do not occur naturally, and thus the method of claim 67 is not a natural phenomenon. Applicant’s argument is found persuasive and the 101 rejection over claim 67 is thereby withdrawn.
Nonstatutory Double Patenting Rejections Overcome by Terminal Disclaimer
Applicant’s terminal disclaimers over co-pending Application No. 18/467,790 in the response filed on March 5th 2026 is acknowledged. The terminal disclaimer is sufficient to overcome the provisional nonstatutory double patenting rejections over co-pending Application No. 18/467,790, and the rejections are thereby withdrawn.
Nonstatutory Double Patenting Rejections Overcome by Argument
Applicant’s arguments in the response filed on March 5th 2026 are acknowledged. Applicant argues that the ULM moiety of co-pending Application No. 18/508,666 does not encompass the ULM moiety of the instant application. The ULM of the instant application,
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is not included in the compound genus of the reference application, which defines the ULM moiety to be selected from:
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Applicant’s argument is thereby found persuasive and the provisional nonstatutory double patenting rejections over co-pending Application No. 18/508,666 are thereby withdrawn.
Nonstatutory Double Patenting Rejections Maintained
Applicant’s arguments in the response filed on March 5th 2026 are acknowledged. Applicant argues that the compounds of the instant application,
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are related to those of Application No. 17/521,195 (now U.S. Patent No. 12,448,389), in that the pending claims are a patently distinct species of the compounds of the reference patent,
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and one of ordinary skill in the art would not reasonably make all of the selections necessary to come upon compounds in the genus of the instant application.
However, not only do the compounds of the instant application act as a subgenus of the reference patent, but the species recited in the instant application make the majority of those selections irrelevant. For example, see the claimed compounds of the reference patent,
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Such compounds differ from applicant’s compound genus,
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ONLY in the selection of R1, which is allowed to be halo, C1-6- alkyl, or haloalkyl in the instant application and H, D, Halo, C1-3 alkyl, C1-3 haloalkyl, or C1-4 alkoxyl in the reference patent. One of ordinary skill in the art would therefore only have to make a single substituent selection to come upon compounds of the instant application, changing the H of the reference patent to any of Halo, C1-3 alkyl, or C1-3 haloalkyl. The subgenus of the instant application is therefore obvious over the compounds of the reference patent.
Nonstatutory Double Patenting Rejections Reiterated
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 1-4, 7-9, 15-16, 20-21, 24, 27, 29, 31-32, 34, 36-37, 39, 41-43, 51, and 54-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 10-12, 14-15, 19, 25, 27, 33-34, 37, 42, 45-53, 66-68, and 72 of copending Application No. 17/521,195 (reference application; now U.S. Patent No. 12,448,389). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application encompasses the claims of the instant application, differing only in certain aspects of the generic claim:
The reference application teaches the compound,
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The reference application claims that the structural portion ULM is “a small molecule E3 ubiquitin ligase binding moiety that binds a Cereblon E3 Ubiquitin Ligase,” while the equivalent position on the generic structure of the instant application is
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, which falls into the genus of ULM on the reference application.
The reference application claims a generic linker group, R1, while the equivalent position on the instant application requires 2 ring structures in the linker, again falling into the genus of the reference application.
Application No. 17/521,195 have been allowed as U.S. Patent No. 12,448,389. The provisional nonstatutory double patenting rejections have thus been converted to nonstatutory double patenting rejections.
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 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629