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
This Office Action is in response to applicant’s arguments filed on 4/28/26. Claims 1-5, 13 have been cancelled. Claims 26-28 have been added. Claims 6-12, 14-28 are pending. Claims 6, 17-18 have been amended. Claims 6-12, 14-28 are examined herein.
The claim amendments have rendered the 112 and 102 rejections over Nishida et al. of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with respect to the remaining 102 rejection over Rinsch et al. has been fully considered but found not persuasive, therefore maintained for reasons of record and modified below due to the claim amendments.
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 6-12, 14-28 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).
Response to Arguments
Applicant argues that the potentially relevant disclosures cited in Rinsch are scattered throughout various parts of the reference and are not arranged exactly as recited in instant claim 6. It is noted that the rejection does not point to Example 7 in the rejection, which is drawn to hair regeneration and not the claimed treatment of alopecia.
This is not persuasive because one of ordinary skill in the art would look to the totality of a reference for what it teaches. Applicant is reminded that Rinsch clearly teaches methods of treating hair loss (claim 36 and throughout the reference) by administering a compound of formula I (page 24, lines 12-25), for example urolithin A (claim 19). Furthermore, just because Example 7 or any other examples may or may not show a preferred embodiment does not take away from the broader teaching.
It is well-settled that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31, USPQ2d 1130, 1132 (Fed. Cir. 1994).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant also argues that Rinsch appears to speculate that hair growth effects may be obtained through modulation of mitochondrial function. However, Rinsch provides no actual results to support this speculation. Moreover, Rinsch discusses a relationship between hair follicle stem cells and mitochondrial function, it provides no objective evidence regarding the relationship between urolithin A and mitochondrial function. Regardless, the present invention is based on the first discovery that urolithin A activates SIRT6. Accordingly, a person of ordinary skill in the art would not have reasonably predicted from Rinsch’s mechanism of action that urolithin would be useful for treating alopecia associated with decreased or deficient SIRT6 activity.
This is not persuasive because whether the mechanism of action goes through mitochondrial function or SIRT6 matters little as long as the cited prior art teaches administration of urolithin A for treating hair loss. Moreover, since these elemental method steps are taught, it is argued that SIRT6 will inherently be activated.
Applicant’s arguments herein are related to the mechanism of action of an agent in the treatment. Note that the mechanism of action of an agent in the treatment, by itself, does not have a bearing on the patentability of the invention if the method steps are already known even though applicant has proposed or claimed the mechanism. Applicant’s recitation of a new mechanism of action for the prior art method will not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
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 extension fee 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 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free).
/Yong S. Chong/Primary Examiner, Art Unit 1623
Prosecution Insights