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 .
Claim Status
Claims 20-28 are pending. Claims 22-28 are withdrawn. Claims 20 and 21 are rejected.
Response to Arguments
Applicant’s statement of common ownership has overcome the previously presented rejections.
Information Disclosure Statement
The information disclosure statement filed June 25th, 2026, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the lined-through information referred to therein has not been considered. The IDS references JP 2015/137266 A, however no copy of the reference or abstract were submitted.
Election/Restrictions
Applicant’s elected species was previously found allowable. As per MPEP 803.02: should the elected species be found allowable, the examination of the Markus-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration. In view of Applicant’s amendments, the examination of the Markush-type claims has been extended to include the scope of claims 20 and 21 where the compound is the following:
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This species has been rejected for nonstatutory double patenting.
Claims 22-28 remain withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 20 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11618746.
The patent discloses compound 16 which is analogous to compound 242 of instant claim 20 (Col. 351):
Compound 16
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Compound 16 differs from the instant compound by having an ethyl linker where the instant compound contains propyl:
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Claim 1 of the patent discloses the following genus which embraces both the instant compound and compound 16 of the patent (Col. 342-345):
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Compound 16 is embraced by formula (I) where R1 is halogen, m is 2, R2 is halogen, n is 1, Y is divalent C2 linear alkyl, R3 and R4 together with the carbon to which they attached form a carbonyl, R5-R8 are each hydrogen.
Instant compound 242 is embraced by prior art formula (I) where R1 is halogen, m is 2, R2 is halogen, n is 1, Y is divalent C3 linear alkyl, R3 and R4 together with the carbon to which they attached form a carbonyl, R5-R8 are each hydrogen.
The patent discloses the genus of formula (I) above where linker Y may be divalent linear or branched C1-C8 alkyl. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
In the interest of generating additional compounds that have the same utility as the compounds taught by the patent, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the patent that have the desired utility. Accordingly, a person of ordinary skill would have been motivated to generate permutations of compound 16 where Y is C3 alkyl as in instant compound 242 of claim 20. MPEP 2144.09 (VIII) states, “[a] prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
Regarding claim 21, claim 18 of the patent discloses a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier (Col. 381).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
