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 .
Status of Claims
Receipt of Arguments/Remarks filed on 6/9/2026 is acknowledged. Claim 29 was amended. New claims 30-36 were added. Claims 1-28 have been canceled. Claims 29-36 are pending.
Withdrawn Rejections
The rejection of claim 29 under 35 U.S.C. § 112(b) is withdrawn.
The rejection of claim 29 under 35 U.S.C. § 101 is withdrawn.
The rejection of claim 29 under 35 U.S.C. § 102 over Deleyrolle et al. is withdrawn.
New rejections necessitated by amendment
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 29, 31, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., WO 2020/224027 in view of Commo, FR2902329A1.
Regarding claim 29, Li teaches a composition comprising glucoraphanin and myrosinase (Li p. 1 para. 2). Li teaches administering the composition to a patient to treat diseases which can be prevented or treated by using glucoraphanin (Li p. 1 para. 2). Li teaches that glucoraphanin is a precursor of sulforaphane that is not biologically active and must be converted to active sulforaphane by myrosinase (Li p. 3 para. 7).
Regarding claim 31, Li teaches that the glucoraphanin in the composition has a content of 9.09% (Li p. 7 para. 28).
Regarding claim 33, Li teaches that the glucoraphanin and myrosinase are derived from cruciferous plants, extracts thereof, and mixtures thereof, i.e. a natural product extract (Li pp. 4-5 para. 13-14).
Regarding claim 34, Li teaches that glucoraphanin is derived from broccoli sprouts (Li claims 3-6; p. 4 para. 13-14), and that myrosinase is derived from kale (Li p. 5 para. 14).
Regarding claim 35, Li teaches that the composition comprising glucoraphanin and myrosinase is a powder, capsule, or tablet (Li p. 6 para. 21).
Regarding claim 36, Li teaches that the product is a food, i.e. is administered or consumed orally (Li p. 6 para. 23).
Li does not teach a method of administering the pharmaceutical composition to a treat leukotrichia in a subject in need thereof (claim 29).
Regarding claim 29, Commo teaches that hair pigmentation requires melanocytes at the hair follicle, and hair whitening is caused by loss of melanocytes (Commo p. 2 para. 1 and 6). Commo teaches that isothiocyanate and its derivatives can be used to treat hair whitening and restore hair pigmentation (Commo p. 3 para. 2). Commo teaches that glucoraphanin is an isothiocyanate derivative which can be used in mixtures for treating hair whitening and loss of pigmentation (Commo p. 3 para. 5; p. 4 first partial para. and first full para.).
It would have been obvious for a skilled artisan to combine the teachings of Li and Commo, arriving at a method of treating leukotrichia comprising administering a pharmaceutical composition as taught by Li to a subject in need thereof. Both Li and Commo teach compositions comprising glucoraphanin that can be administered to patients to treat diseases. Commo teaches that glucoraphanin can be used to treat hair whitening and loss of hair pigmentation. Thus, it would have been obvious that a composition as taught by Li, comprising glucoraphanin, could be administered to a patient to treat leukotrichia, or whitening of the hair.
A person of ordinary skill in the art would have been motivated to use the composition of Li in a method of treating leukotrichia because Commo teaches that isothiocyanate derivatives such as glucoraphanin can oppose hair whitening and lead to the restoration of pigmentation. Leukotrichia is a whitening of hair, and thus a skilled artisan would have been motivated to administer a composition comprising glucoraphanin, which is known to treat hair whitening, to treat a patient with this condition. Further, Li teaches that glucoraphanin must be activated by myrosinase, as it is not biologically active, as discussed above. Therefore, it would be considered advantageous to use a composition comprising both glucoraphanin and myrosinase, which activates the glucoraphanin, to treat a condition with glucoraphanin.
A skilled artisan would have had a reasonable expectation of success in using the composition of Li in a method of treating leukotrichia because Commo teaches administering compositions comprising isothiocyanate derivatives to restore pigmentation of hair. Thus, a skilled artisan could expect that a composition as taught by Li, which comprises glucoraphanin and its activator myrosinase, could be successfully used for this same purpose.
Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Li and Commo, as applied to claims 29, 31, and 33-36 above, and further in view of Bramanti et al., WO 2014/060509 A1.
Regarding claims 30 and 32, Li and Commo teach a method for treating leukotrichia by administering a composition of glucoraphanin and myrosinase as set forth above. Li teaches that glucoraphanin is not biologically active and must be activated by myrosinase (Li p. 3 para. 7). These references do not teach that the myrosinase has an enzyme activity of 0.1 mU to 10 U, or 0.3 mU to 5 U based on total weight of the composition.
However, the amount of myrosinase in the composition would have been routinely optimized by a skilled artisan based on the other assay conditions. Li clearly teaches that the myrosinase is provided in an amount effective to achieve the result of activation of glucoraphanin. That means the conditions necessary to achieve the activation of glucoraphanin by myrosinase were result-effective variables. Result-effective variables would be optimized through routine experimentation by one having ordinary skill in the art. Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A).
Additionally, Bramanti teaches a composition comprising glucoraphanin and myrosinase that is administered to treat diseases (Bramanti p. 1 lines 5-11, p. 3 lines 19-25). Bramanti teaches that glucoraphanin is activated with myrosinase and has antioxidant and anti-inflammatory properties (Bramanti p. 8 lines 1-3). Bramanti teaches that myrosinase is administered in the composition in an amount of 0.4-120 U/day (Bramanti p. 10 lines 25-34). Therefore, a skilled artisan would have found it obvious, through the process of routine experimentation, to arrive at a composition for use in treating leukotrichia comprising myrosinase with a total enzyme activity in the range of 0.3 mU to 5 U, given the teachings of Bramanti that such an amount of myrosinase can be administered daily as a treatment in combination with glucoraphanin, and is sufficient to activate glucoraphanin.
Response to Arguments
In light of amendments to the claims, the rejection of claim 29 under 35 U.S.C. § 102 has been withdrawn. However, upon further consideration, new grounds of rejection of claims 29-36 are made under 35 U.S.C. § 103 as set forth above. Given these new grounds of rejection, the arguments presented regarding claim 29 rejected under 35 U.S.C. § 102 are moot.
Conclusion
Claims 29-36 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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