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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/29/2022, 07/12/2023, and 10/25/2023 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of the comp in the reply filed on 09/15/2025 is acknowledged.
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 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23, 28 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT03830762 (provided as cite no. C4 on IDS filed 3/29/22).
NCT03830762 teaches the oral administration of XanamemTM to cognitively healthy subjects. The subjects are 50 to 75 and in good health (Brief Summary). Doses of 20mg or 30mg are administered daily (Brief Summary, Detailed Description). Instant claims drawn to outcomes are inherent to said administration. Accordingly, claims 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23, 28 and 31 are anticipated.
Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Claims 1, 3-7, 12, 14-15, 17-19, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webster et al (provided as cite no. C8 on IDS filed 3/29/22).
Webster teaches administration of UE2343 which is equivalent to the elected species (compound 4, p. 401) to healthy subjects (including males). Doses of 10, 20 and 35 mg were administered twice daily (p. 399). Under broadest reasonable interpretation, this reads on the administration of the elected species to the claimed patient population (a cognitively healthy subject). Claims drawn to patient outcomes are drawn to inherent properties upon administration. Accordingly, claims 1, 3-7, 12, 14-15, 17-19, 21-23, 28 and 30-31 are anticipated.
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.
Claims 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over NCT03830762 (provided as cite no. C4 on IDS filed 3/29/22).
NCT03830762 teaches the oral administration of XanamemTM to cognitively healthy subjects. The subjects are 50 to 75 and in good health (Brief Summary). Doses of 20mg or 30mg are administered daily (Brief Summary, Detailed Description). Instant claims drawn to outcomes are inherent to said administration.
NCT03830762 does not teach a twice-daily dosage of 10 mg per dosage.
Modification of dosage and dose scheduling is routine in the art and amounts to routine optimization. A PHOSITA would have found the dosing parameters of claim 30 obvious in view of the once-daily 20mg or 30mg dosage taught by NCT03830762. Accordingly, claims 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23 and 30-31 are obvious.
Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Claims 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (provided as cite no. C8 on IDS filed 3/29/22).
Webster teaches administration of UE2343 which is equivalent to the elected species (compound 4, p. 401) to healthy subjects. Doses of 10, 20 and 35 mg were administered twice daily (p. 399). Under broadest reasonable interpretation, this reads on the administration of the elected species to the claimed patient population (a cognitively healthy subject). Claims drawn to patient outcomes are drawn to inherent properties upon administration.
Webster does not teach administration to cognitively healthy subjects wherein the subject has an increased risk of cognitive decline (claims 9 and 11).
Webster teaches UE2343 as a 11beta-HSD1 inhibitor and its use for treating AD (Conclusions and Implications, Abstract). “In aged rodents, modulation of 11β-HSD1 by genetic knockdown or pharmacological inhibition improves memory ..., while treatment of cognitively impaired healthy elderly men and patients with type 2 diabetes, with the non-selective 11β-HSD1 inhibitor carbenoxolone, has been shown to improve memory.” (Introduction, p. 397). A PHOSITA would have been motivated to administer UE2343 to subjects at increased risk of cognitive decline in view of these teachings. There would have been a reasonable expectation of success in preventing and/or treating cognitive decline based on its known 11beta-HSD1 inhibitory activity. Accordingly, claims 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23, 28 and 30-31 are obvious.
Conclusion
Claims 1, 3-7, 9, 11-12, 14-15, 17-19, 21-23, 28 and 30-31 are rejected.
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