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 1-20 are pending.
Claims 5, 7, 11, 18, and 20 are withdrawn (see election/restriction).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application claims priority to PRO application number 63/540,821, filed 9/27/2023.
Information Disclosure Statement
No IDS has been filed as of 6/16/2026.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 6/01/2026 is acknowledged. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of using.
Applicant’s election of the compound of claim 16 (see below) without traverse in the reply filed on 6/01/2026 is acknowledged. Claims 5, 7, 11, and 18 are withdrawn as not reading on the elected species.
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(Elected Species)
Claims 1-4, 6, 8-10, 12-17, and 19 will be examined on their merits.
Anticipatory art was not found on the elected species, however the Examiner found anticipatory art on two expanded species (see below).
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(Expanded Species from claims)
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(Expanded species- dexamethasone)
Further, the elected species is rejected using an obviousness-type rejection. See 102/103 analysis below.
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 1-4, 9-10, 14-15, and 19 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Merck (US3079383A; published 1963; “Merck”).
This rejection applies to the expanded species.
Merck teaches compounds for use as steroid bio isosteres. More specifically, Merck teaches a structural example of the expanded specie (Example 5, Compound 3, Page 6).
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(Merck, Page 6)
The expanded specie reads on claims 1-4, 9-10, 14-15, and 19, and therefore, these claims are anticipated by Merck.
Claims 1-4, 8-9, 12, and 19 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Merck (US3049556A; published 1962; “Merck”).
This rejection applies to the expanded species of dexamethasone.
Merck teaches compounds for use as steroids. More specifically, Merck teaches a structural (via text) example of the expanded specie (Example 5, Page 3).
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(Merck, Page 3)
The expanded specie reads on claims 1-4, 8-9, 12, and 19, and therefore, these claims are anticipated by Merck.
Allowable Subject Matter
Claims 6, 13, 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Closest prior art:
Merck (US3079383A; published 1963; “Merck”). Merck teaches dexamethasone. Dexamethasone has a similar structure to the elected species (which reads on the objected claims) however dexamethasone and its derivatives do not allow for a pyrroline ring replacement for the 5-memebered ring. Indole derivatives on other anti-inflammatory compounds are known for improved biological activity in many different drug classes (Kumari, A. et al. Bioorganic Chemistry, 89, 2019, 103021). However, pyrroline and indole are not isosteres nor could the examiner find any prior art claiming them as bioisosteres. Therefore, the Examiner does not think it would be obvious to a person skilled in the art to substitute the 5-memebered ring in dexamethasone with a pyrroline ring.
Conclusion
Claims 1-4, 8-10, 12, 14-15, and 19 are rejected. Claims 6, 13, 16-17 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621