DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Previous Rejections
Applicant’s arguments, filed December 30, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-71, 74, 77, 79, 81, 84, 87, 89, and 91 are cancelled.
Claims 72-73, 75-76, 80, 82-83, 85-86, 88, and 90 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 72-73, 75-76, 80, 82-83, 85-86, 88, and 90 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chaudhuri (US 2009/0036545 A1; of record), in view of Mehta (US 8,865,138; of record).
Chaudhuri teaches compositions comprising bakuchiol for ameliorating, reducing and/or reversing the manifestation of the dermatological signs of chronologically aged, hormonally-aged and/or photo-aged skin (pg 20, claim 1). Chaudhuri teaches the limitation of an oral capsule (pg 4, [0039]).
For the amount of bakuchiol in the oral capsule recited in claims 72, 76, 80, 82, 86, and 90, Chaudhuri teaches (pg 6, [0059]): “For oral application, a dose/day/adult is about 10 to 500 mg one or twice a day. Still, as with all pharmacological agents, it is best to use only that level of the meroterpene active as is necessary to achieve the desired result without adverse consequences to the individual.” As such, Chaudhuri teaches the amount of bakuchiol in an oral capsule is between about 10 to 500 mg and one of ordinary skill is able to determine the required dose through routine optimization. The person of ordinary skill in the art would have found it obvious to optimize within the range taught by Chaudhuri because Chaudhuri teaches a range of bakuchiol that is effective in an oral capsule.
Regarding the limitations regarding the amount of furanocoumarin impurities recited in claims 72, 73 and 83, Chaudhuri teaches: “The preferred meroterpene or meroterpene extract is that comprising bakuchiol, especially purified bakuchiol, and extracts containing the same, most especially those that are free of or substantially free of furocoumarins.”
The limitation of “wherein the composition is effective to alleviate, reduce, or treat the excess pigmentation resulting from post inflammatory hyperpigmentation” does not appear to alter the elements of the claimed composition, and these elements are identical to the composition taught by Chaudhuri. As set forth in MPEP 2112.01(I), “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant
discloses and/or claims are necessarily present. Id. Chaudhuri teaches a composition comprising bakuchiol of the claimed purity and in the claimed amount, and therefore is considered to be obvious over the claimed composition.
For the claims 76-78 and 87-88, Chaudhuri teaches (at pg 7, [0064]):
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For claims 77 and 87, Chaudhuri teaches oral capsules, as discussed supra.
Chaudhuri does not teach the addition of salicylic acid to the composition comprising an oral capsule.
Mehta teaches the missing element of Chaudhuri.
Mehta teaches salicylic acid as a skin lightening agent in an oral carrier or capsule (col 2: 9-10; col 49: 59-65; col 60; and col 60: 66 to col 61: 2).
The skilled artisan would have expected success in combining Mehta's salicylic acid to the oral bakuchiol composition taught by Chaudhuri since Chaudhuri teaches the oral bakuchiol composition is useful for ameliorating, reducing and reversing the visual manifestations of chronologically aged, hormonally-aged and/or photo-aged skin, which frequently include age spots and Mehta teaches orally dosed salicylic acid as a skin lightening agent. It is noted that both Chaudhuri and Mehta teach the form of an oral capsule. The person of ordinary skill in the art would have
found it obvious to make the combination because ordinarily skilled artisans would have predicted that salicylic acid would be safe and effective based on the compounds' shared activity. See MPEP 2144.06 and 2144.07.
Examiner’s Reply to Attorney Arguments dated 12/30/2025
1. Rejection of claims 72-73, 75-78, 80, 82-83, 85-88, and 91 under 35 USC §103(a) over Chaudhuri and Mehta
The applicant argues that the cited prior art of Chaudhuri and Mehta, either individually or together, does not teach the limitation of claims 72 and 82 of: “a composition that is effective to alleviate, reduce, or treat the excess pigmentation resulting from post inflammatory hyperpigmentation”.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. Claims 72 and 82 are directed to a composition, specifically an oral capsule comprising purified bakuchiol. As set forth in MPEP 707.07(f), “a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.” In the instant case, the recitation of “a composition that is effective to alleviate, reduce, or treat the excess pigmentation resulting from post inflammatory hyperpigmentation” merely recites an intended use or purpose of the claims’ composition and does not result in a structural difference between the claimed invention between the claimed invention and the invention described by Chaudhuri, as modified by Mehta, discussed in the rejection above.
CONCLUSION
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612