Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Instant application 18/627,081 filed on 04/04/2024 claims benefit as follows:
CONTINUING DATA:
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Status of the Application
Claims 23-52 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/16/2026 is acknowledged.
Claims 34, 35, 47, 48, 51 and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/16/2026.
Regarding species election, Applicant’s election without traverse of compound 326 in the reply filed on 06/16/2026 is acknowledged.
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Claims 25, 31 and 36-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/16/2026.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Double Patenting
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
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 23, 24, 26-30, 32, 33 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25 of U.S. Patent No. 9682966-B2. Although the claims at issue are not identical, they are not patentably distinct from each.
The claims of U.S. Patent No. 9682966-B2 recite:
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Further, regarding instant claim 28, the claims of U.S. Patent No. 9682966-B2 recite:
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Furthermore, the claims of U.S. Patent No. 9682966-B2 (see claim 12) recite compound 233
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Compound 233 falls under instant Formula (I) wherein m = 0 (R2 is absent); W and X taken together with the atoms to which they are bonded form a fused 6-membered aryl substituted with methyl; Y is H; Z is 5 membered heteroaryl mono substituted with C1 alkyl (3-methyl-1,2,4-oxadiazol-5-yl); Cyc is piperidine, bonded to Ring A via the nitrogen atom; R1 is (CH2)nNRaRb, Ra and Rb taken together form a unsubstituted heterocyclyl (substituted with 0 independently selected J.
The claims of U.S. Patent No. 9682966-B2 also recite:
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Therefore, the instant claims are anticipated.
Claims 23, 24, 26-30, 32, 33 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-34 of U.S. Patent No. 10,118,915-B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of U.S. Patent No. 10,118,915-B2 are directed to the use of compounds falling under instant Formula (I).
The claims of U.S. Patent No. 10,118,915-B2 recite:
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For example, the claims of U.S. Patent No. 10,118,915-B2 recite the method wherein the compound is (see claim 22):
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The above compound falls under instant Formula (I) wherein m = 0. (R2 is absent W and X taken together with the atoms to which they are bonded form a fused 6-membered aryl substituted with methyl; Y is H; Z is 5 membered heteroaryl mono substituted with C1 alkyl (3-methyl-1,2,4-oxadiazol-5-yl); Cyc is piperidine, bonded to Ring A via the nitrogen atom; R1 is (CH2)nNRaRb, Ra and Rb taken together form a unsubstituted heterocyclyl (substituted with 0 independently selected J.
For double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), See Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). We held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use." Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86
In Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n. 9; see U.S. Patent No. 5,563,165 ("′165 patent"), at col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n. 9; see U.S. Patent No. 5,760,068 ("′068 patent") col.97 l.49-col.108 l.29. After rejecting the patentee's objection to our consideration of the specification of the earlier patent, we determined that the later patent "merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent." Pfizer, 518 F.3d at 1363. As such, we concluded that the asserted claims of the later patent were not "patentably distinct" from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
Thus, the holding of Geneva and Pfizer, that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," extends to any and all such uses disclosed in the specification of the earlier patent. Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.
Conclusion
Claim 49 is allowed.
Claims 23, 24, 26-30, 32, 33 and 50 are rejected.
Claims 25, 31, 34-48 and 51-52 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A 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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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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