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 24 June 2026 in response to the non-final rejection mailed 24 March 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 24 June 2026 replaces all prior versions and listings of the claims.
Claims 1-9 and 21-31 are pending. Claims 10-20 are canceled by Applicant’s amendment. Claims 21-31 are newly added. Claims 1-3 and 7 are amended. Claims 1-9 and 21-31 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on page 4 of the reply filed 24 June 2026 with respect to the rejection of Claims 1 and 4-9 under 35 USC § 102 have been fully considered. The rejections of Claims 1 and 4-9 are withdrawn due to amendment of Claim 1.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Leclere (FR 2876909 A1, Translation, 8 pages) in view of Dell’Acqua et al. (US 2022/0323532).
The instant claims are as of record, drawn to hair treatment compositions comprising a first and a second fraction of lipid vesicles, each comprising different materials.
Leclere teaches cosmetic compositions comprising liposomes of chaulmoogra oil (second fraction of lipid vesicles encapsulating a second material; botanical bioactive material) and liposomes of caffeine (first fraction of lipid vesicles encapsulating a first material; stimulant material; first material and second material are different; Leclere, Example 1, page 7; as required for instant Claims 1 and 4-6). The caffeine is present between 0.1-8% by weight of the composition and the chaulmoogra oil is present between 0.1-15% by weight of the composition (no more than approximately 15 wt%; no more than approximately 20 wt% of total of first and second fractions of lipid vesicles; e.g., 5 wt% caffeine and 10 wt% chaulmoogra oil would be 15 wt% total; Leclere, page 5; as required for instant Claims 8 and 9). Additionally, chaulmoogra oils are known in the art to be used in hair lotions for promotion of hair growth (hair treatment; Leclere, page 3; as required for instant Claim 1).
Leclere does not teach wherein the first or second fraction of lipid vesicles are extracellular vesicles or plant-derived lipid vesicles or the specific Ayurvedic botanical bioactive materials of Claim 7.
Dell’Acqua et al. teach a composition comprising exosome-like nanovesicles or exosomes (extracellular vesicles, see e.g., [0244]; plant-derived lipid vesicles, see e.g., [0260]) derived from Withania somnifera (e.g., plant-derived; Dell’Acqua, Abstract; as required for instant Claims 2, 3, and 7). The composition may also comprise caffeine (Dell’Acqua, [0083]) and is useful for effecting a change in hair appearance, hair growth, hair pigmentation, hair follicle size or hair shaft size (Dell’Acqua, Abstract).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the Withania somnifera exosomes of Dell’Acqua in the composition of Leclere because plant-derived exosomes are biological nanostructures which provide various hair-related improvements and are provided in compositions for topical application to the hair, such as shampoos and conditioners (Dell’Acqua, [0221], [0244]). Alternatively, a skilled artisan could provide exosomes derived from chaulmoogra with a reasonable expectation of success because proteins in exosomes from the same cell-type but of different species are highly conserved (Dell’Acqua, [0260]), and thus a skilled artisan could reasonably expect similar hair-related improvements by providing exosomes extracted from another plant type known to have hair-related benefits. A skilled artisan could therefore incorporate both chaulmoogra exosomes and Withania somnifera exosomes into the composition in order to arrive at the instantly claimed invention with a reasonable expectation of success.
Claims 1-9 and 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (US 20240075089 A1) in view of Lian et al. (J Extracell Vesicles, 2022, 32 pages).
The instant claims are as of record, drawn to a hair treatment compositions comprising a first and a second fraction of lipid vesicles, each comprising different materials.
Feldman et al. teach compositions suitable for growing and melanizing hair (hair treatment composition) comprising 0.0001-0.0010 wt% caffeine (first material; stimulant material; no more than 15 wt% or 20 wt%; Feldman et al., Claims 63-66; Tables 14 and 17; as required for instant Claims 1, 4, 5, 8, 9, 22, 25, 27, and 29) and 0.01-4.00 wt% Eclipta prostrata (second material; botanical bioactive material; Ayurvedic botanical bioactive material; extract see e.g., [0090]; no more than 15 wt% or 20 wt%; Feldman et al., Claim 63; as required for instant Claims 1, 6, 7, 8, 9, 22, 26, 27, 30, and 31).
Feldman et al. do not teach wherein the first and second materials are encapsulated in plant-derived exosomes.
Lian et al., however, teach that plant-derived extracellular vesicles (lipid vesicles; exosomes) represent a new class of therapeutics and are biocompatible and remain stable in the human body even when administered orally (Lian et al., pg. 3). Additionally, they are capable of protecting and delivering hydrophilic or hydrophobic payloads to target sites and can be derived from various plant sources such as grapefruit, strawberries, ginger, ginseng, tomatoes, oranges, red cabbage, cabbage, cucumbers, peppers, and carrots (Lian et al., pg. 3 & Table 2; as required for instant Claims 1-3, 21-24, 27, and 28).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the compounds of the composition of Feldman et al. as encapsulated compounds as taught by Lian et al. and would be motivated to do so because plant-derived extracellular vesicles are useful for drug loading and delivery, are cost-effective, safe, and have excellent cellular update (Lian et al., pg. 18-19). Additionally, a skilled artisan could do so with a reasonable expectation of success because plant-derived vesicles have successfully been used in preclinical trials (Lian et al., Abstract, pg. 1).
With respect to the rejections above, please note that the intended use of the claimed
Composition as a hair care composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
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.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 24 June 2026 have been fully considered but they are not persuasive.
Applicant argues that there is not a prima facie case of obviousness because Leclere is directed to a topical slimming gel, however the intended use of the claimed composition as a hair care composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP § 2112).
Additionally, the chaulmoogra oils are known in the art to be used in hair lotions for promotion of hair growth (hair treatment; Leclere, page 3; as required for instant Claim 1) and the composition of Dell’Acqua comprises Withania somnifera and caffeine and is useful for effecting a change in hair appearance, hair growth, hair pigmentation, hair follicle size or hair shaft size (Dell’Acqua, Abstract). It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose (see e.g., MPEP § 2144.06). A skilled artisan would therefore have a reasonable expectation of success at combining these ingredients and obtaining a hair care composition.
Applicant also argues that adding Withania somnifera to the composition of Leclere would render it unsatisfactory for its intended purpose and destroy the caffeine/chaulmoora synergy, however, is not found to be persuasive, because such a teaching is not present in the disclosure of Leclere. Leclere indicates that various other ingredients can be included in the composition (Leclere, pg. 5-6), including one or more substances known to have beneficial effects on the skin such as plant extracts (Leclere, pg. 5).
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).
Conclusion
No claims are currently 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 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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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.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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