DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the second Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 08 October 2025, Applicant amended claims 1, 2, 4-7, 11, 16, 18, 23, 28-30, 33, 36, 40, and 53-54. Claims 8, 10, 15, 17, 19-22, 24-27, 31-32, 34, 37-39, 41-46, 57-58, and 62 were previously cancelled by Applicant. Claims 1-7, 9, 11-14, 16, 18, 23, 28-30, 33, 35-36, 40, 47-56, and 59-61 are pending. Claims 35, 47-56, and 59-60 remain withdrawn because each of those claims is directed to a non-elected invention or species. Claims 1-7, 9, 11-14, 16, 18, 23, 28-30, 33, 36, 40, and 61 are under consideration.
Status of the Rejections and Objections
The rejection of claims 1-7, 9, 11-14, 18, 28-30, 33, 36, 40, and 61 under 35 U.S.C. 101 is maintained. Applicant’s argument is considered in paragraphs 15-18 of this Office action.
The rejection of claims 1-7, 9, 11-14, 16, 18, 23, 28-30, 33, 36, 40, and 61 under 35 U.S.C. 112(b) has been modified in view of Applicant’s recent amendments. This rejection now applies to claims 2, 5-7, and 11 only.
The rejection of claims 2, 7, and 11 under 35 U.S.C. 112(d) is withdrawn in view of Applicant’s recent amendments thereto. However, the examiner notes that those amendments have rendered claims 2, 7, and 11 indefinite under 35 U.S.C. 112(b).
The objection to claims 16 and 23 indicating allowable subject matter is new and has been necessitated by Applicant’s clarifying amendment to claim 1.
Claim Rejections – 35 U.S.C. 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 9, 11-14, 18, 28-30, 33, 36, 40, and 61 are rejected under 35 U.S.C. 101 because they are directed to non-statutory subjected matter defined by the judicial exception for products of nature.
Exosome-like nanovesicles or exosomes extracted from Withania somnifera are products of nature, as evidenced by the specification of the present application. See, e.g., page 32 at lines 1-4 (“As used herein, the term ‘extract’ or ‘isolated’ are used interchangeably herein and includes separating one or more substances (e.g. Withania somnifera exosome-like nanovesicles) from a mixture (e.g. a Withania somnifera plant).”). The examiner’s position is additionally supported by the following three evidentiary references: (1) Nemati, M., et al. Plant-derived extracellular vesicles: a novel nanomedicine approach with advantages and challenges. Cell Commun Signal 20, 69 (2022); (2) Mu, N., et al. (2023). Plant-Derived Exosome-Like Nanovesicles: Current Progress and Prospects. International Journal of Nanomedicine, 18, 4987–5009; and (3) Chu, K., et al. (2024). Herbal Medicine-Derived Exosome-Like Nanovesicles: A Rising Star in Cancer Therapy. Int’l Journal of Nanomedicine, 19, 7585–7603.
The foregoing evidentiary references, as well as the specification, individually and collectively support the examiner’s position that claims 1-7, 9, 11-14, 18, 28-30, 33, 36, 40, and 61 are directed to a product of nature. Stated another way, the exosomes and compositions comprising them — as claimed — lack markedly different characteristics from their naturally occurring counterparts. The presence of a pharmaceutically acceptable carrier (e.g., water, glycerin, alcohol) is merely a nominal or token extra-solution component of the claims, and is nothing more than an attempt to generally link the product of nature (exosomes/nanovesicles from Withania somnifera) to a particular technological environment (pharmaceutical or cosmeceutical formulations). Therefore, even claims 9, 29-30, 33, and 36 — when considered as a whole — fail to integrate the judicial exception for natural products into a practical application.
In the interest of clarity, the examiner notes this rejection does not apply to claims 16 and 23, both of which require combinations of products of nature that are not naturally occurring.
In sum, claims 1-7, 9, 11-14, 18, 28-30, 33, 36, 40, and 61 do not include additional elements that are sufficient to amount to significantly more than the judicial exception for products of nature. Accordingly, it is appropriate to reject them under 35 U.S.C. 101. MPEP §§ 2106.04–2106.07.
Response to Applicant’s Argument
The following remarks are provided in response to the argument raised by Applicant on page 9 of the Reply filed 08 October 2025:
In Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), the Pseudomonas bacterium had a different structural characteristic: it was genetically modified to include more plasmids than are found in a single naturally-occurring Pseudomonas bacterium. It is that genetic modification which resulted in the advantageous functional characteristic, i.e., the ability to degrade at least two different hydrocarbons as compared to naturally-occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. Thus, the Supreme Court’s holding in Chakrabarty is predicated on a markedly different structural characteristic (genetic modification). Turning to the present application, the isolated exosomes, as presently claimed, do not require a structural characteristic that markedly differentiates them from their naturally-occurring counterparts. Accordingly, Chakrabarty does not support Applicant’s position. See MPEP § 2106.04(c)(II)(C)(1).
In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 106 USPQ2d 1972 (2013), the Supreme Court made clear that not all changes in structural characteristics will rise to the level of a marked difference. For example, the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. MPEP § 2106.04(c)(II)(C)(2). Applicant argues that the claimed exosomes “never result from natural phenomena and are products of purely human engineering” because they have been isolated “from the remainder of the organic matrix and cellular milieu in which the exosomes naturally occur.” Reply, p. 9. However, the changes asserted by Applicant are merely incidental to the process of isolation. In other words, they are not different enough from what exists in nature to avoid improperly tying up the future use and study of exosomes that naturally occur in Withania somnifera. MPEP § 2106.04(c)(II)(C)(2) (“The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes.”), citing Myriad, 569 at 585, 106 USPQ2d at 1977.
The foregoing §101 rejection is maintained.
* * *
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 2, 5-7, and 11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claims 2, 7, and 11 (as amended), the phrases “suitable for stimulating hair growth or preventing hair loss in a subject” (claim 2), “suitable for treating, preventing, or reversing sparse hair growth, short hair growth, thin hair growth…” (claim 7), and “suitable for preventing or reversing cortisol-induced growth arrest in human follicle dermal papilla cells” (claim 11) are functional limitations. Persons having ordinary skill in the art can reasonably disagree over the scope of those limitations because it is unclear how they further limit the exosome composition defined in claim 1. For example, do they require a minimum effective concentration of the extracted exosomes to be capable of (suitable for) achieving the recited therapeutic effect, e.g., stimulating hair growth? Are specific classes of carrier, penetration enhancer, and/or other excipient required? Applicant is referred to MPEP § 2173.05(g), which provides that “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite.”
Regarding claims 5 and 6 (as amended), the phrase <heat shocked> remains unclear. Persons having ordinary skill in the art can reasonably disagree over which combinations of heating temperature and heating duration are sufficient to heat shock Withania somnifera. MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”). Applicant is again encouraged to clarify these claims by incorporating the heat shock conditions described on page 17 of the specification. Both temperature and duration are required to bring the claims into compliance with 35 U.S.C. 112(b). The new phrase recited at the end of claims 5 and 6 — i.e., “wherein the heat-shock conditions comprise heating the Withania somnifera” — does not overcome the §112(b) rejection because it still is unclear what degree of heating and for what duration is sufficient to induce heat-shock. For example, is placing the Withania somnifera in a greenhouse on a hot, sunny summer day sufficient? What about growing lamps? How much time (exposure to the heat) is needed? Those questions underscore the uncertain scope of claims 5 and 6.
Claim Objections
Claims 16 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
* * *
Conclusion
Claims 1-7, 9, 11-14, 18, 28-30, 33, 36, 40, and 61 are rejected.
Claims 16 and 23 are objected to.
No claim is allowed.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax 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 Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/P.A./
24 January 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611