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 third 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.
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 18 May 2026 has been entered.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 18 May 2026 cites the following foreign patent publication: JP10045541 (Pola Chem Ind Inc). However, Applicant has not provided a copy of that publication, thereby failing to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document, each non-patent literature publication or that portion which caused it to be listed, and all other information or that portion which caused it to be listed. Furthermore, Applicant has not provided (1) an explanation of its relevance, (2) a written English-language translation, or (3) an English-language abstract. Applicant is referred to 37 CFR 1.98(a)(3)(i), which requires — in regard to each document listed on an IDS that is not in the English language — that patent applicants submit “[a] concise explanation of the relevance, as it is presently understood by the individual designated in § 1.56(c) most knowledgeable about the content of the patent.” Accordingly, JP10045541 has not been considered by the examiner.
Applicant is additionally referred to 37 CFR 1.98(a)(3)(ii), which further requires that patent applicants submit “[a] copy of the translation if a written English-language translation of a non-English-language document, or portion thereof, is within the possession, custody, or control of, or is readily available to any individual designated in § 1.56(c).”
Applicant is advised that the date of any resubmission of any item of information contained in this IDS or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all requirements for statements under 37 CFR 1.97(e). MPEP § 609.05(a).
Status of the Claims
Applicant amended claims 1, 5-6, 53-54, and 59. Additionally, Applicant (i) cancelled claims 2, 7, 11, 56, and 60; and (ii) added four new claims, i.e., claims 63-66. 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, 3-6, 9, 12-14, 16, 18, 23, 28-30, 33, 35-36, 40, 47-55, 59, 61, and 63-66 are pending. Claims 35, 47-55, and 59-60 remain withdrawn because each of those claims is directed to a non-elected invention or species.
Restriction/Election
Pursuant to 37 CFR 1.142(b), claims 63-65 are withdrawn from further consideration by the examiner because they are directed to non-elected Group II. See Office Action (06 December 2024) at page 2.
Claims 1, 3-6, 9, 12-14, 16, 18, 23, 28-30, 33, 36, 40, 61, and 66 are considered below.
Status of the Rejections and Objections
The rejection under 35 U.S.C. 101 is maintained. The examiner notes that the following evidentiary reference is newly cited: Jayathilaka (“Growth and polyphenol content of Ashwagandha (Withania somnifera L. Dunal) under combined drought stress and salicylic acid treatment.” Discover Plants 2.1 (2025): 56).
The rejection of claims 2, 5-7, and 11 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s (i) clarifying amendments to claims 5-6 and (ii) cancellation of claims 2, 7, and 11. The examiner appreciates Applicant’s effort to advance prosecution.
The objection to claims 16 and 23 indicating allowable subject matter is maintained.
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, 3-6, 9, 12-14, 18, 28-30, 33, 36, 40, 61, and 66 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.
Regarding claims 5-6 (as recently amended), the following additional evidentiary reference is considered especially relevant: (4) Jayathilaka, M. S., et al. “Growth and polyphenol content of Ashwagandha (Withania somnifera L. Dunal) under combined drought stress and salicylic acid treatment.” Discover Plants 2.1 (2025): 56. Jayathilaka states: “Ashwagandha (Withania Somnifera L. Dunal) is a medicinal plant, also known as Indian Ginseng and Amukkara, belonging to family Solanaceae. This woody shrub, which grows to a maximum height of 150 cm thrives in semi tropical with annual rainfall of 500 to 750 mm and temperatures between 20 °C to 38 °C, is cultivated as a late rainy season crop.” (Emphasis added) Page 1. The foregoing temperature range establishes that neither the heat-shock limitation of claim 5 nor the negative heat-shock limitation of claim 6 results in growing conditions that are not naturally occurring.
The isolated exosomes, as presently claimed, do not require a structural characteristic that markedly differentiates them from their naturally-occurring counterparts, in contrast to the bacterium in Diamond v. Chakrabarty, 447 U.S. 303 (1980) (a genetic modification to a naturally-occurring Pseudomonas bacterium that yields an advantageous functional characteristic is patent-eligible under 35 U.S.C. 101). See MPEP § 2106.04(c)(II)(C)(1).
The foregoing observations and evidentiary references, as well as the specification of the present application, support the examiner’s position that claims 1, 3-6, 9, 12-14, 18, 28-30, 33, 36, 40, 61, and 66 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., solution, aqueous solution, 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).
Applicant’s recent assertion that glycerin has “humectant,” “emollient,” and “texturizer” activities (Reply, p. 10) does not vitiate the well-known fact that glycerin (glycerol) has been commonly used as a solvent or co-solvent in biological research laboratories for decades. Applicant’s compositions, as claimed, still 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 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). Therefore, the claims — 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 again that 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, 3-6, 9, 12-14, 18, 28-30, 33, 36, 40, 61, and 66 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.
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.
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Conclusion
Claims 1, 3-6, 9, 12-14, 18, 28-30, 33, 36, 40, 61, and 66 are rejected.
Claims 16 and 23 are objected to.
No claim is allowed.
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.
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/P.A./
26 June 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
Prosecution Insights