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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-17, in the reply filed on 1/22/26 is acknowledged. Claims 18-20 have been canceled in the amendment filed on 1/22/26
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation directed to the first compound of formula B where R is OH or alkoxy, and the claim also recites the second compound where R is limited to OH which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al (WO 2021/077119).
Scope of prior art
On pages 398, 399 and 406 Allred teaches compounds 4, 5 and 13, respectively, which are conjugates of the currently claimed compounds H and B:
Compound 4:
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242
716
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Compound 5:
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228
732
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Compound 13:
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236
708
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Compounds 4, 5 and 13 have a halogen counterion, however other non-halogen counterions are recited throughout the disclosure and in claim 2:
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110
800
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In claim 24 Allred teaches pharmaceutical composition for topical delivery.
Ascertaining the difference
The difference between rejected claims and disclosure of Allred is that the currently claimed compounds H and B are hydrolysis products of Allred’s compounds 4, 5 and 13. Also, while Allred teaches a chloride counterion, current claims exclude halogen anions.
Obviousness
A skilled artisan would have found it obvious to prepare a topical formulation comprising a non-halogen salt of compounds 4, 5 and 13 of Allred. At issue is whether the currently claimed compound H and B would be present in the topical formulation. Example 10 in the current specification indicates that the conjugate compound exists in equilibrium with the hydrolysis products, which are compound H and B of current claims. Compound of Allred therefore also exist in equilibrium with its hydrolysis products, compounds H and B. Therefore, the formulation of Allred inherently comprises the currently claimed compounds H and B at claimed ratios.
Current claims are directed to non-halogen counterion. While Allred exemplifies chloride counterion, art also establishes equivalency between chloride and non-halogen counterions. It would therefore be obvious to substitute one of the non-halogen counterions for chloride with an expectation that the resulting product will have the same utility.
Conclusion
Claims 1-17 are pending
Claims 1-17 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 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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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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