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 .
Response to Arguments
Applicant’s arguments, see pp. 10-11, with respect to the objection to claim 11; the rejection to claims 12 and 15 under 35 U.S.C. 112(a); and the rejection of claims 11-17 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Amendments overcome the objection/rejection(s). The rejection of 02/26/2026 has been withdrawn.
Applicant's arguments filed 06/24/2026 with respect to the rejection of claims 11-17 under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by WO2018132372A1 have been fully considered and are persuasive in part.
Amendments overcome the rejection of claims 13-14 and 16-17.
With respect to claims 11-12 and 15, applicant argues that the reference does not disclose the compounds recited as Formulas I and II, the compounds’ unique binding mode with NAMPT, the compounds’ distinct SAR, or the use of the compounds in treating CIPN.
The compound cited reads on a compound of Formula II as explained in the 02/26/2026 Non-Final Rejection at p. 6. Claims 11-13 do not require any of the properties cited by applicant, and therefore the arguments are moot. Claim 15 recites “(G) a NAMPT agonist, wherein the NAMPT agonist comprises the aromatic compound of Formula I or Formula II as defined in claim 11; or (H) a drug for treating neurodegenerative diseases or anti-aging, wherein the drug comprises the aromatic compound of Formula I or Formula II as defined in claim 11, and wherein the neurodegenerative disease is CIPN”. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See NOEO 2111.02(II). In the instant case, the body of the claim defining the compound as a compound of Formula I or II and administration thereof fully sets forth all of the limitations of the claimed invention. Furthermore, applicant argues that the prior art compound exhibits only weak NAMPT agonist activity. Strong activity is not required by the claims. Applicant’s arguments at 12-14 appear to be directed toward obviousness. It remains that the cited compound reads on a compound of Formula II of claim 11 wherein X is NH; Y is O; n is 0, R10 is ester, and R1-R9 are reach H. See below for reference:
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. Applicant suggests that the prior art compound would not be selected as a lead compound and that other(s) may be preferred by a PHOSITA; however, the compound is used as a reference for anticipation and not obviousness and therefore lead compound analysis is moot. With respect to arguments regarding various properties, the properties discussed are not required by the claims. Furthermore, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Note that (F) of claim 12 remains anticipated, as (F) merely requires administration of the aromatic compound of Formula I or Formula II as defined in claim 11. The intended use is not given patentable weight as there is no requirement that administration be directed to a subject in need thereof. "If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999). See also Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In considering the effect of the preamble in a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the claims’ recitation of a patient or a human "in need" gives life and meaning to the preamble’s statement of purpose.). Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). See MPEP 2111.02. Accordingly, the rejection of claims 11-12 and 15 under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by WO2018132372A1 is maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-13 and 15-17 are rejected under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by WO2004009533A1 to Wilde et al.
Wilde et al. teaches the compound
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(p. 34) which is a compound of Formula I of claim 11 wherein X is O; Y is O; n is 0; R2 is C1 alkyl; R3 is branched C3 alkyl; R10 is carboxyl; and R1 and R4-R9 are H. The compound is a sodium salt, thereby reading on claims 13 and 16-17. The compounds are useful for treating or preventing diseases such as aging (p. 7), thereby reading on (F) of claim 12 and (H) of claim 15. Accordingly, claims 11-13 and 15-17 are anticipated.
Conclusion
Claims 11-13 and 15-17 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam 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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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
