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 .
Benefit of Earlier Filing Date
The instant application, filed 22 March 2024, is a national stage application of PCT/US2022/076868, filed 22 September 2022, which claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/248,047, filed 24 September 2021. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Requirement for Restriction/Election was mailed 22 May 2026.
Applicant’s Response to Requirement for Restriction/Election was received 22 July 2026.
Applicant’s election without traverse of Group I (Claims 1-4, 11-12, 17-20, 24-26, 32-33, and 37-40) and Compound TM2, shown below, and indication of claims 1, 2, 11, 17, 20, 26, 32, and 37-40 as being readable on the elected species in the Response filed 22 July 2026 is acknowledged.
The claim in Group II (Claim 42) is withdrawn.
The claims which do not read on the elected species (Claims 3-4, 12, 18-19, 24-25, and 33) are also withdrawn.
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In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable.
Status of the Claims
The listing of claims filed 24 June 2024 has been examined.
Claims 1-4, 11-12, 17-20, 24-26, 32-33, 37-40, and 42 are pending.
Claims 2-4, 11-12, 17-20, 24-26, 32-33, 40, and 42 amended.
Claims 3-4, 12, 18-19, 24-25, 33, and 42 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species.
Claims 5-10, 13-16, 21-23, 27-31, 34-36, 41, and 43-53 are cancelled.
Claims 1-2, 11, 17, 20, 26, 32, and 37-40 are examined on the merits.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 30 July 2024, 07 October 2025, and 31 March 2026 are acknowledged and have been considered. Any lined-through references have not been considered and must be submitted or resubmitted in proper format for consideration. For example, a copy of an NPL document titled “International Preliminary Report on Patentability in International Appln. No. PCT/US2022/076868, mailed March 26, 2024, 8 pages” is missing. However, an International Preliminary Report on Patentability mailed 04 April 2024 is present, but not listed on the IDS filed 30 July 2024. Additionally, an NPL document titled “Wagner et al., “Kovalente Bindung von 1-Aminoadamantanderivaten an Proteinantigene nach dem Isothiocyanat-und dem Imidasaureesterverfahren,” Pharmazie, 1981, 36(6):400-402 (English Abstract)” is too blurry to read.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains a phrase which can be implied, specifically the phrase, “The present disclosure relates to…,” as well as legal phraseology, specifically the term “comprising.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “…RB and RC is independently hydrogen, C1-C6 alkyl, C1-C6 haloalkyl, or…” [Emphasis added.] For clarity, Examiner suggests amending “is” to “are.”
Appropriate correction is requested.
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 1-2, 11, 17, 20, 26, 32, and 37-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishii (US 2011/0172230 A1).
Regarding claims 1-2, 11, 17, 20, 26, 32, and 37-39, Ishii teaches a compound of Formula (I), which is called Ex 293 by Ishii (p. 103, Table 52, Ex 293):
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In Ex 293, X is -CA-R1, Y is CH, Z is CH, Q is C(=O), A is O, R1 is C2 alkyl substituted with C6 cycloalkyl, Ring B is 6 membered heterocyclyl, R3 is -C(=O)NHRA, and RA is phenyl. Ishii’s Ex 293 is structurally identical to instantly claimed Compound TM2.
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 1-2, 11, 17, 20, 26, 32, and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Ishii (US 2011/0172230 A1).
Regarding claims 1-2, 11, 17, 20, 26, 32, and 37-40, Ishii teaches pharmaceutical compositions containing an active ingredient which may further comprise a pharmaceutically acceptable carrier and/or an excipient (p. 14, ¶ [0279]). When said composition is solid, Ishii discloses possible inactive excipients include lactose, mannitol, glucose, hydroxypropylcellulose, microcrystalline cellulose, starch, polyvinyl pyrrolidone, and/or magnesium aluminometasilicate or inactive additives like magnesium stearate and/or carboxymethylstarch sodium (p. 14, ¶ [0281])..
Ishii does not explicitly teach exemplary compositions.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Ishii would have found it prima facie obvious to prepare a composition comprising Compound TM2 and a pharmaceutically acceptable excipient based on the teachings of Ishii because Ishii discloses pharmaceutical compositions and various excipients as well as a compound which is structurally identical to Compound TM2 (p. 103, Table 52, Ex 293). Furthermore, Ishii’s compound is structurally similar to and used in producing compounds which have activity as fatty acid amide hydrolase (FAAH) inhibitors (p. 36, ¶ [504]; p. 1, [0006]). Thus, a PHOSITA would have been motivated to prepare a composition comprising Compound TM2 and an excipient since both elements are taught by Ishii and a PHOSITA would recognize including additional excipients in a composition can result in improved pharmaceutical characteristics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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, ADAM C 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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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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