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 .
Claims 1-41 are currently pending in this Application.
Priority
CONTINUING DATA
This application has PRO 63/430,989 12/07/2022
Information Disclosure Statement
Applicant’s Information Disclosure Statements, filed on 10/25/2024 and 05/01/2025 have been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
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, 22-24 and 26-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-11 of U.S. Patent No.12,351,537. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claims are either anticipated by, or would have been obvious over, the reference claims.
The instant claims are directed to products of Formula I,
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165
227
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as defined in claim 1. The species that are covered by the products of Formula (I) include,
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133
252
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Claim 1 in US Patent No. 12,351,537 B2 is directed to a method of treating mental health disease using products of Formula:
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135
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Claim 7 in US ‘537 specifically claims the method of using compound:
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141
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Therefore, both sets of claims ( claims 27-41 of the instant claims) use the same products to treat the same disorders. The difference is only in scope.
With respect to some of the instant claims (claims 1-5, 23, 24) being directed to a different statutory class of invention compared to the conflicting claims of US ‘537 (some of the instantly claimed invention is drawn to compounds rather than the method of using the compound), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer.
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
MPEP 804 states : “where the claims of an application are not the "same” as those of the first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper.”
Although the conflicting claims are not identical, the Examiner finds that a person having ordinary skill in the art would recognize that the claimed invention would unjustly extend the rights granted to U.S. Patent No.12,351,537, because a hypothetical infringer of U.S. Patent No.12,351,537 would necessarily be an infringer of the claimed invention. Accordingly, U.S. Patent No.12,351,537 renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise.
Claim Objections
Claims 6-21 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The products claimed in these claims are outside the scope of the claims of the specific products used in U.S. Patent No.12,351,537.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
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