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 .
Status of the Claims
Claims 1, 14-16, 21-24, 26-35 are pending. Claims 16, 21-22, and 26-34 are withdrawn. (**Note from Examiner: New claims 26-34 do not embrace Applicant’s elected species and are consequently withdrawn from consideration.) Claims 1, 14-15, 23-24, and 35 are rejected.
Response to Amendments/Arguments
Applicant’s arguments and amendments, filed 12/16/2025, with respect to the rejection(s) of claim(s) 1-5, 12, 14-15, and 23-24 under 35 USC 102 and 35 USC 103 have been fully considered and are persuasive. Therefore, these rejections have been withdrawn and Applicant remarks from 12/15/2025 will not be addressed. However, upon further consideration and as necessitated by amendments, a new ground(s) of rejection is made below.
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.
Claim(s) 1, 14-15, and 23 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by McCall et al. (US8916561).
Regarding instant claims 1 and 14-15, McCall teaches the following compound:
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, as useful in the treatment of diseases such as diabetes mellitus in human or animal subject (see column 1, lines 11-16 and column 56, bottom right). “Compounds and prodrugs may be administered orally or via injection….” (see column 19, lines 30-31). The prior art compound is embraced by a compound of the following formula in instant claim 1 (and dependent claims 14-15):
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, wherein R1 and R2 = C6 aryl, each substituted by one R10 (halo, F); R4 = Cy1 = 5 membered heteroaryl. Regarding instant claim 23, the compound shown supra is identical to BC19144.
The instant claims are drawn to a “method for increasing NAMPT activity within a mammal, wherein said method comprises administering, to said mammal, an effective amount [of an instantly claimed compound]”, wherein any compound embraced by instant formula:
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would inherently have such activity upon administration to a mammal (such as a human or animal subject). See MPEP 2112.02: “[W]hen the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated.” In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 24 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCall et al. (US8916561).
The 102 rejection supra of claims 1, 14-15, and 23 over McCall et al. (US8916561) is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
McCall discloses the following: “insulin resistance can be manifested in serval ways, including Type 2 diabetes. Type 2 diabetes is the condition most obviously linked to insulin resistance” (see column 22, lines 13-15).
McCall additionally teaches that Example 25, shown supra, has successfully inhibited the targeted kinase of the prior art:
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(see column 98).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art fails to disclose a single embodiment of Example 25 of the prior art treating insulin resistance syndrome.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
The inherency of the prior art compound increasing NAMPT activity was established supra in the 102 rejection.
Regarding instant claims 24 and 35, it would have been obvious to a skilled artisan to treat an insulin resistance syndrome with a compound that was suggested to treat diabetes. A PHOSITA would have reasonably had the knowledge that insulin resistance syndrome in a mammal is a very similar condition, if not overlapping with a diabetes in a mammal. A skilled artisan would have had a reasonable expectation of treatment success of insulin resistance in administering a compound of instant formula
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, suggested for the treatment of diabetes.
Conclusion
Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action. Accordingly, THIS ACTION IS MADE FINAL. 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 extension fee 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 MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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