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 .
Claim Status
Applicant’s remarks and amendments, filed 2 June 2026 in response to the non-final rejection mailed 9 February 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 2 June 2026 replaces all prior versions and listings of the claims.
Claims 1 and 3-8 are pending. Claim 2 is canceled by Applicant’s amendment. Claims 1, 3, and 7 are amended. Claims 1 and 3-8 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Claim Objections
Applicant is advised that should Claims 7 and 8 be found allowable, Claims 5 and 6, respectively, will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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 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.
Claims 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Morley (US 10,709,659 B1) as evidenced by Sangwan et al. (US 7,108,870 B2) and in view of Pandey et al. (Asian J Biol Sci, 2019, 10 pages).
The instant claims are as of record, drawn to a method for stimulating hair growth in a person comprising administration of a composition comprising a Withania somnifera extract.
Morley teaches methods for promoting (stimulating) hair growth and reducing hair loss by administering to a subject (human; Morley, col. 10, ln. 10-11) an effective amount of a composition comprising at least 100 mg of withanolides (extract of Withania somnifera; Morley, col. 8, ln. 49-64; as required for instant Claim 1). The composition comprises 100-1000 mg of an extract of the roots and leaves of Withania somnifera, which comprises the active compounds known as withanolides, including withaferin A (extract of Withania somnifera; Morley, col. 5, ln. 1-20; as required for instant Claims 1 and 3). The extract of Withania somnifera is obtained via known methods (Morley, col. 5, ln. 18-19), which includes the method Sangwan et al., and thus the extract may comprise 100% withaferin A (Sangwan et al., Abstract). A composition of Claim 6 (Morley, col. 12, ln. 45-50) would therefore comprise 100-1000 mg of Withania somnifera extract which is withaferin A, in a composition with a total weight of 405-2205 mg, or 4.5-76.6% (w/w) withaferin A (all withanolides) by total weight of the composition (as required for instant Claims 2-4). Calculations are as follows:
Minimum: 100 mg withaferin A in 2205 mg composition [Wingdings font/0xE0] 4.5%
Maximum: 1000 mg withaferin A in 1305 mg composition [Wingdings font/0xE0] 76.6%
The composition also comprises an extract of Curcuma longa, which comprises volatile oils of turmeric rhizome (essential oils; Morley, col. 10, ln. 45-47; as required for instant Claims 5 and 7), and a pharmaceutically suitable vehicle (carrier; Morley, col. 9, ln. 26-37; as required for instant Claims 5 and 7). The composition is provided in various dosage forms, including for parenteral administration and as transdermal patches (topical application; Morley, col. 9, ln. 38-50; as required for instant Claims 5 and 7).
Morley does not explicitly teach that the transdermal patch or parenteral formulation is applied to the scalp.
Pandey et al., however, teach a method for stimulating hair growth in rats comprising administration of a composition to denuded skin (topical scalp application; Pandey et al., In vivo hair growth activity, p. 3-4; as required for instant Claim 1). The composition comprises an extract of Withania somnifera fruits, aloe vera gel as a spreading agent (surfactant; pharmaceutically acceptable carrier; Pandey et al., page 7; as required for instant Claims 6 and 8), and stabilizers (Pandey et al., Preparation of formulations, page 3).
It would have been obvious a person of ordinary skill in the art prior to the effective filing date of the instant application to administer the topically applied composition of Morley to the scalp as taught by Pandey et al. A skilled artisan would know that in a human, hair loss often occurs on the scalp, and therefore would be motivated to topically apply the composition of Morley to the scalp of a person requiring stimulation of hair growth because Pandey et al. show the effectiveness of a composition comprising an extract of Withania somnifera to denuded skin. Additionally, Pandey et al. demonstrate that the topically applied composition comprising an extract of Withania somnifera was non-irritating and non-toxic to the skin, providing further motivation and a reasonable expectation of success for topical application of the composition of Morley.
Morley and Pandey et al. are relied upon for the reasons discussed above. If not expressly taught by Morley, based upon the overall beneficial teaching provided by this reference with respect methods of withanolide extraction produced in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable withaferin A or total withanolide ranges in which to perform such a method), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
(grounds modified as necessitated by amendment)
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 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 24 and 26-29 of copending U.S. Patent Application No. 18/272,015 (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, wherein withaferin A is added to the extract such that the composition includes at least 20% (w/w) withaferin A (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 Claim 3 differs from ‘015 Claim 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 extract which comprise at least 20% (w/w) withaferin A.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have, as of the mailing of the instant communication, not in fact been patented.
Response to Arguments
Applicant's arguments filed 2 June 2026 have been fully considered but they are not persuasive.
Applicant argues that an extract of Withania somnifera cannot comprise 100% withaferin A, however the extract of Withania somnifera as taught by Morley is obtained via known methods (Morley, col. 5, ln. 18-19), which includes the withaferin A isolation method disclosed by Sangwan et al. (Sangwan et al., Abstract) and referenced as a known method in the disclosure of Morley, and thus the extract may comprise 100% withaferin A. It is additionally noted that the applicant argues their method differs from the prior art because purified (e.g., isolated) withaferin A is used to supplement the composition of the instant disclosure. A composition of Claim 6 as disclosed by Morley (col. 12, ln. 45-50) would therefore comprise 100-1000 mg of Withania somnifera extract which is withaferin A, in a composition with a total weight of 405-2205 mg, or 4.5-76.6% withaferin A (all withanolides) by total weight of the composition. Calculations are as follows:
Minimum: 100 mg withaferin A in 2205 mg composition [Wingdings font/0xE0] 4.5%
Maximum: 1000 mg withaferin A in 1305 mg composition [Wingdings font/0xE0] 76.6%
These ranges overlap those of the instant claims and thus the composition is the same, absent evidence that adding additional withaferin A to achieve the same total amount results in a composition different from that of the prior art.
Applicant additionally argues that Morley discloses a host of agents for formulation of a hair growth composition and therefore does not describe or suggest using a Withania somnifera extract alone which has been modified to formulate a hair growth composition. Firstly, it is noted that the composition applied to the scalp for stimulating hair growth on a person merely comprises Withania somnifera extract. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP § 2111.03). Secondly, instant Claim 5 indicates that the composition is combined with one or more essential oils, which encompasses the extract of Curcuma longa, which comprises volatile oils of turmeric rhizome as taught by Morley (col. 10, ln. 45-47).
Conclusion
No claims are currently allowed.
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 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
