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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/826,275
This Office Action is in response to the amended claims of 11/19/2024.
Claims 32-43 are new and are examined in this office action.
Priority
The effective filing date is 05/17/2022 because application find support on Provisional application no 63/342,828.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/06/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 32-42 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-2, 7, 13, 19 and 21-28 of U.S. Patent No. 12,122,750. Claim set of 11/19/2024 was used to write this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-11, 13 19, 21-22 discloses the compound genus formula
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(reference claims 1-11) corresponding to the species(
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,
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and
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in reference claims 21-22) where X is
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(C5-10 heteroaryl); R1 is
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(aryl) R2 is
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(substituted C3-6cyclo alkyl) and R3 is H same as compound of instants claims 32-34.
Furthermore reference claim 21 discloses compound
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of claim 32(Column 333, lines 30-50), reference claims 21-22 discloses compound
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of claim 33 (column 365, lines 25-45, in claim 22 column 368, lines 50-65) and compound
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of claim 34 (in claim 21 column 365, lines 45-65, in claim 22 column 369, lines 5-20) thus anticipating claims 32-34.
Reference claim 22 discloses pharmaceutical composition, or a pharmaceutically acceptable salt there of and one or more pharmaceutically acceptable carrier, diluent or excipients same as instant claims 35-37.
Reference claim 24 discloses method of treating pain comprising administering to a subject in need thereof a therapeutically effective amount of the compound or a pharmaceutically acceptable salt thereof same as instant claims 38, 40 and 42.
Reference claims 25-28 discloses method wherein the pain is neuro-pathic pain, inflammatory pain, nociceptive pain, mixed nociceptive and neuropathic pain(reference claim 26), visceral pain, post-operative pain, post-herpetic pain, traumatic pain, phantom-limb pain, fibromyalgia syndrome, back pain, cancer pain, chemotherapy induced neuropathic pain (CINP), or osteoarthritic (OA) pain same as instant claim 39,41 and 43.
Conclusion
No claims are allowed as written.
Applicants are encouraged to file terminal disclaimer to over anticipatory double patenting rejection.
US’ Patent no. 12,122,750 teaches compounds
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,
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and ,
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of independent claims 32, 33 and 34 respectively. However publication date of US ‘750 is Nov. 23, 2023 after the priority date of instant application, therefore US ‘750 is a close art not a prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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