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 the Application
Applicant's election of the species (urolithin A and hair loss caused by alopecia other than androgenic alopecia) in the reply filed on 11/10/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-25 are pending and examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 18 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The limitation “common foods and drinks” renders the claim indefinite as to what exactly this food or drink is. The specification does not clearly define what the definition of “common” is. Therefore, the metes and bounds of patent protection sought for this specific limitation has not been defined.
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 6-11, 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishida et al. (WO 2014/042261, of record).
Nishida et al. teach a sirtuin gene potentiatior comprising as an active ingredient a specific polyphenol for use in pharmaceutical, cosmetic, and food products (abstract on page 2). A preferred polyphenol is urolithin A (first paragraph on page 4). The pharmaceutical composition can be in the form of a tablet, capsule, powder, granule, sustained-release agents, solutions, syrups, and emulsions. The active ingredients can be in the amount of 0.1-50% by mass (second full paragraph on page 6). Additives conventionally used in the preparation of pharmaceuticals, for example excipients, can be used (paragraph bridging pages 5-6).
It is noted that the limitation “a method for preventing hair loss or gray hair, or inhibiting hair follicle stem cell aging” reads on everyone because everyone is in need of hair loss or gray hair prevention. Furthermore, since all the elemental steps of the method claim has been taught by the cited prior art, it is inherent that hair follicle stem cell aging will be inhibited.
Claims 6-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinsch et al. (WO 2019/211294, of record).
Rinsch et al. teach the method of preventing, inhibiting, or slowing bodily hair loss or baldness, loss of hair color or hair greying during ageing, or a method of hair follicle stem cell regeneration by administering a compound of formula I (page 24, lines 12-25), for example urolithin A (claim 19). Those that would benefit from an increase in hair follicle stem cell growth or hair growth are subjects with alopecia areata, androgenic alopecia, male pattern baldness, and chemotherapy induced alopecia (page 25, lines 18-26). The amount of the active agent can be from 250-1500 mg once or twice a day (page 36, lines 10-27) or can be from 0.1 to 80% w/w of the composition, preferably 0.25 to 5% or 20-40% (page 46, lines 1-13). In the case for improving existing hair or improving hair growth, the composition is a tonic, lotion, serum, shampoo, conditioner, spray, gel, or cream in a concentration of 0.01 µM to 100 mM, for example 50 µM or 100 µM (which equates to 11.4 mg and 22.8 mg due to the molecular weight of urolithin A being 228 g/mol) (page 26, lines 1-10). Oral compositions in the form of a tablet, capsule, granule, powder, suspension, solution, emulsion, or syrup are taught (page 42, lines 10-17). The composition can be provided as a single serving supplement to a subject’s general diet, for example a bar or drink or can be part of or the whole of a meal (page 45, lines 7-11). Pharmaceutical excipients are taught (page 53, line 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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