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 .
Election/Restrictions
Claims 24-34 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 24-29 in the reply filed on 6 October 2025 is acknowledged. Claims 30-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 October 2025.
Claims 24-29 are being examined on the merits.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuang et al. (Int Immunopharmacol, 2020, 7 pages).
The instant claims are as of record, drawn to a method for increasing expression of beta-catenin or mTOR in a group of cells by providing said group of cells with an effective amount of a composition comprising an extract of Withania somnifera.
Kuang et al., however, anticipate the claims by teaching a method wherein human bone mesenchymal stem cells (group of cells) are treated (provided) with Withanolide B extractable from Withania somnifera (composition; extract of Withania somnifera; Kuang et al., Introduction, pages 1-2; Materials and methods, pages 2-3; as required for instant Claim 24). This treatment resulted in an increase in expression of beta-catenin in the cells (effective amount; Kuang et al., Figure 3, pages 3; as required for instant Claim 24).
Claim Objections
Claims 25-29 are objected to as depending directly or indirectly from rejected base claim 24.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of copending Application No. 18/395,515 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘515 Claim 1 and ‘015 Claim 24 both recite administration of a composition comprising Withania somnifera to a subject (e.g., human which comprises mammalian cells). While the intended uses of the compositions differ (stimulating hair growth versus increasing expression of β-Catenin or mTOR), the composition and manner of use (e.g., “applying” and “providing” as a topical application) are the same. Additionally, applying the composition of ‘515 to the skin of the scalp places it into contact with cells, which would then be subject to increased expression of β-Catenin or mTOR. Absent evidence to the contrary, the single-step method of applying a composition comprising an extract of Withania somnifera does not result in a structural difference due to the differing intended uses and therefore the claims are not patentably distinct from one another.
‘515 Claims 2 and 3 differ from ‘015 Claims 25 and 26 regarding wording, however the ultimate result of an extract of Withania somnifera comprising Withaferin A wherein the composition comprises at least 20% (w/w) Withaferin A are the same and thus not patentably distinct.
‘515 Claims 4, 5 and 7, and 6 and 8 comprise the same limitations as ‘015 Claims 27, 28, and 29, respectively, and differ only regarding dependency, however they are not patentably distinct because the extract of Withania somnifera broadly encompasses extracts which comprise at least 20% (w/w) Withaferin A.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant Art Made of Record
The following art is considered relevant and puts into context the state of the art regarding Withaferin A, its inclusion in hair growth compositions, and its biochemical activity.
Nile et al. (Food Chem Toxicol, 2019, 9 pages) teaches the yield and composition of withanolides extracted from Withania somnifera. While Withaferin A is one of the most prevalent withanolides, it comprises 20-23 weight% of the total withanolides within the extract (Nile et al., Table 2, page 6); it is important to consider that withanolides are not the only compounds present in water, methanolic, or ethanolic extracts of Withania somnifera, and thus the percentage of Withaferin A in the extract as a whole will be lower, necessitating the addition of exogenous Withaferin A to obtain the claimed amounts. While Withaferin A may be isolated from various plants including Withania somnifera as taught by Sangwan et al. (US 7,108,870 B2) and purified Withaferin A obtained via this method can be included in hair growth and hair loss reduction compositions for topical application as taught by Morley (US 10,709,659 B1), Withaferin A is known in the art to down regulate beta-catenin and mTOR expression. Suman et al. (Oncotarget, 2016, 13854-13864) teaches that Withaferin A administered to human colorectal cancer cells causes significant inhibition of beta-catenin expression (Suman et al., Abstract, page 13854; Figure 5C, page 13858). Additionally, Grogan et al. (Invest New Drugs, 2013, 20 pages) teaches that Withaferin A administered to human glioblastoma multiforme cells inhibits the Akt/mTOR signaling pathway (Grogan et al., 3.4, page 6). Ultimately, a skilled artisan would not be motivated to add Withaferin A to the composition of Kuang et al. or have a reasonable expectation of success with doing do because it is known in the art to have the opposite effect of the intended utility of the method for increasing beta-catenin and mTOR expression in a group of cells.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655