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 .
Non-Final Rejection
Priority
This Application was filed on 18 June 2024 and is a continuation of application 17951640, which was filed on 23 September 2022, issued as US 12054486 on 06 August 2024 and which claims priority to Provisional Application 63/248,330 filed on 24 September 2021.
Information Disclosure Statement
The IDS dated 05 November 2024 has been received, entered and considered, a copy is included herein.
Status of the claims
Amended claims dated 05 November 2024 have been entered.
Claims 1-23 were cancelled by the Applicant.
Claims 24-43 are pending and rejected.
Claim Objection
Claim 39 is objected to over the following informal issue:
There is an “is” missing in the definition for the R2 moiety:
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Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Said (Monatsh Chem 2009, 140, 573–579, IDS).
See compound 2 on page 574 and table 3 on page 576. The structure is shown below for convenience:
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Compound 2 is a compound of formula (I), wherein X is =C(R9)- and R9 is hydrogen; Y is =C(R9)- and R9 is methyl; R1 is phenyl
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, n is 1-3 and R4 is hydrogen; R2 is -R10-N(R11)2, R10 is a direct bond and each R11 is hydrogen; R3 is 4,5-dihydro-1H-imidazol-2-yl
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, and R6 and R7 are each hydrogen.
The compound is disclosed in table 3 at page 576 and the experimental part for “Analgesic activity” at page 579 as being administered to a mammal (a mouse) to effectively treat the pain condition induced by contact with a hot surface. The compound falls into the scope of the genus of formula (I) as above and pain is considered to be a condition “modulated by a voltage gated sodium channel” under the broadest reasonable interpretation of this claim term.
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 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 12054486 (IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are anticipated by and/or obvious over those of the reference patent.
Reference claim 24 is drawn to a method of use which falls entirely into the scope of examined independent claim 24.
Reference claim 26 falls entirely into the scope of examined dependent claim 28 and independent claim 32.
Reference claim 33 falls entirely into the scope of examined independent claim 39.
One or more of the species of examined claims 25-27, 33-35 and 40-41 are at least obvious to select from those listed in reference claims 25 or 30.
Examined claims 29-31, 36-38 and 42-43 specify the same diseases as those listed in reference claims 34-35 and it would at least be obvious to treat these diseases with the reference methods.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL R CARCANAGUE whose telephone number is (571)270-3023. The examiner can normally be reached 9 am to 5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on (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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/DANIEL R CARCANAGUE/ Primary Examiner, Art Unit 1621