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 .
DETAILED ACTION
This office action is in reply to the Response to Restriction/Election filed on 03 June 2026 for application 18/685,690 filed on 22 February 2024, 371 of PCT/US2022/041253 filed on 23 August 2022, with PRO 63/236,145 filed on 23 August 2021. Claims 4, 8, 12, 15, 24, 29, 32, 35 and 50-51 are amended. Claims 2-3, 5-7, 9-11, 13-14, 17-19, 21-23, 25-28, 30-31, 33-34, 37-39, 41-49, 52-54, 57-58, 60 and 64-66. Currently, claims 1, 4, 8, 12, 15-16, 20, 24, 29, 32, 35-36, 40, 48-51, 55-56, 59 and 61-63 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 04 June 2026 were filed after the mailing date of the application on 22 February 2024. The submission is 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 of Group I without traverse in the reply filed on 03 June 2026 is acknowledged.
Applicant’s election of compound 5a/b, 4-(4-Hydroxyphenyl)tricyclo[3.3.1.13,7]-decane-1-methanol, illustrated below, in the reply filed on 03 June 2026 is acknowledged:
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Lack of election made on the second species for Group II in the reply filed on 03 June 2026 is acknowledged.
As informed by the Applicant, claims 20, 32, and 35 read upon the elected species.
Claims 1, 4, 8, 12, 15-16, 24, 29, 36, 40, 48-51, 55-56, 59 and 61-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03 June 2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 20 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Basarić et al. (Photochemical formation and chemistry of long-lived adamantylidene-quinone methides and 2-adamantyl cations, J. Org. Chem. 2010, 75, 102-116).
Basarić discloses compounds 10 and 12 which read upon formula II where R1a = R1b = R2 = R3 = R4 = R5 = R6 = H and R1c = OH or H:
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As such, Basarić anticipates claim 20.
With regards to the limitation of claim 32, where R2 = R3 = R4 = R5 = R6 = R1c = H, are met as Basarić discloses compound 12 which reads upon formula II(c).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 non-obviousness.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Basarić et al. (Photochemical formation and chemistry of long-lived adamantylidene-quinone methides and 2-adamantyl cations, J. Org. Chem. 2010, 75, 102-116) in view of Allen et al. (Ansel’s pharmaceutical dosage forms and drug delivery systems 10th edition, Wolters Kluwer Health 2005).
Basarić discloses compounds 10 and 12 which read upon formula II and II(c).
They do not, however teach about pharmaceutical compositions.
Allen rectifies this deficiency by extensively covering many topics within the field of drug formulation, including, but not limited to, typical properties of select excipients, incompatibilities, safety, related substances, along with numerous other examples in categories such as disintegrants, adhesives, and surfactants (select reading; pg. 1 – section I: introduction to drugs, drug dosage forms, and drug delivery systems; pg. 101 – section II: drug dosage form and drug delivery system design).
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to incorporate the teachings of Allen to develop an appropriate formulation for a structure according to formula II or II(c) for use in the desired method of treatment utilizing well established literature that is exemplified by Allen.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the elected species 5a/b, 4-(4-Hydroxyphenyl)tricyclo[3.3.1.13,7]-decane-1-methanol was found to be free of the prior art:
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The closest match is compound 12 disclosed by Basarić et al. (Photochemical formation and chemistry of long-lived adamantylidene-quinone methides and 2-adamantyl cations, J. Org. Chem. 2010, 75, 102-116):
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Summary
Claims 20 and 32 are rejected under 35 U.S.C. 102(a)(1). Claim 35 is rejected under 35 U.S.C. 103. The elected species was found to be allowable subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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