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 .
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.
Claim 3 is 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.
Claim 3 recites the limitation " the method of claim 1 wherein the at least one additional active agent" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 from which claim 3 depends from fails to recite an additional agent. For purposes of prior art examiner is interpreting claim 3 to depend from claim 2 which recites “further comprises at least one additional agent”.
Claim Rejections - 35 USC § 102
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.
Claims 1-7, 12 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lazar (WO 2020024056 A1).
Regarding claims 1-7, 12 and 25, Lazar teaches a method for treating/reducing hair loss or promotion of hair growth in a subject in need (para. 0008) comprising administration of a topical composition (para. 0010) to the skin/scalp region (para. 0093) of a cannabinoid of CBD (relevant to claims 1 and 6)(para. 0007) and absorbable material (abstract). The composition as taught by Lazar in the form of a cream, a lotion, a cosmetic serum, a solution, a gel, an ointment, a paste, a bio adhesive and powder (relevant to claims 4 and 25) (para. 0096).
The amount of CBD present in the composition is between about 0.001 wt% and about 20 wt% of the total weight of the composition (relevant to claims 5 and 7) (para. 0044). Lazar additionally teaches the composition further comprising agents of caffeine, ginseng extract and hydrolyzed wheat powder (relevant to claims 2-3 and 12) (para. 0064, 0070).
Claims 1-4, 6, 8 and 12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Roots Professional, “Imperium CBD hair products”, https://web.archive.org/web/20210422170341/https://www.rootsprofessional.com/pages/comparison-chart-education, April 2021, Pages 1-7 (from the IDS).
Roots professional hereafter will be referred to as Roots.
Regarding claims 1-4, 6, 8 and 12, Roots teaches a composition for reducing hair loss and promoting hair growth comprising CBD, caffeine, arginine and minoxidil (relevant to claims 1-3, 6 and 12) (Pg. 1 and 6). Roots additionally teaches the composition as a topical shampoo and conditioner (known in the art to be a gel, cream or lotion) (relevant to claim 4) (Pg. 7) and the composition is released over 12 hours (relevant to claim 8) (Pg. 3).
Claims 1-4, 6 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. Hair Regrowth with Cannabidiol (CBD)-rich Hemp Extract -A Case Series, Medical life Care Planners, January 2021, Pages 53-59.
Regarding claims 1-4, 6 and 11, Smith teaches a composition for the treatment of Androgenetic alopecia (AGA) and promoting hair growth comprising a topical hemp oil formulation of CBD in conjunction with minoxidil (relevant to claims 1-4 and 6) (abstract). Smith additionally teaches the minoxidil present in an amount of 1% topical solution (relevant to claim 11) (Pg. 54, 2nd para.).
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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lazar (WO 2020024056 A1) in view of Bissett et al. (WO 2019232242 A1).
The teachings of Lazar for the above 102 rejections of claims 1-7, 12 and 25 are incorporated herein by reference.
Lazar fails to teach the hair loss composition administered between 0.1 g and 30 g, and the composition applied in combination with microneedling.
Bissett teaches methods for promoting hair growth comprising disruption of the skin with a powered needling device (microneedling), followed by an administration of one or more hair growth-promoting agent (abstract). Of the hair growth-promoting agent Bissett teaches a topical solution of minoxidil and/or caffeine (Pg. 3-4, 68). Bissett additionally teaches any agent that promotes hair growth and/or treats a disease or condition associated with hair loss that is known in the art or yet developed is contemplated for use in the methods disclosed (Pg. 65-66).
Therefore it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the CBD composition taught by Lazar in conjunction with the microneedle, wherein the composition is administered between 0.1g and 30g. One would have been motivated to do so from the teachings of Bissett of microneedling in combination with hair growth agents of minoxidil and/or caffeine as well as stating any agent that promotes hair growth with the teachings of Lazar of promoting hair growth comprising agents of CBD and caffeine. There is a reasonable expectation of promoting hair growth in a subject in need comprising a composition of CBD and caffeine in conjunction with a microneedle from the teachings of Lazar and Bissett.
One would also be motivated to administer the composition taught by Lazar between 0.1 g and 30 g as of routine experimentation. As 0.1 g to 30 g is a wide difference in dosage amounts one would by routine experimentation apply different administration amounts to test for the least to best results, additionally as per MPEP 2144.05 (II): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627