DETAILED ACTION
Status of the Claims
Applicant’s response dated August 7, 2026 has been entered. Claims 19, 21, 23-30, 35, and 36 are pending and under examination. Claims 1-18, 20, 22, and 32-34 are cancelled. Claim 31 is withdrawn from further consideration as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112 – Indefiniteness – Withdrawal
The rejection of claims 19-30, 35, and 36 under 35 U.S.C. 112(b) is withdrawn. Applicant has amended independent claim 19 to recite a specific numerical range for the amount of oil of Anisomeles species, thereby removing the “effective amount” language that formed the basis of the indefiniteness rejection. In view of the amendment, the prior 112(b) rejection is no longer maintained.
Claim Rejections - 35 USC § 101 – Judicial Exception – Maintained
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 19, 21, 23-30, 35, and 36 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, namely a product of nature / natural phenomenon, without reciting additional elements that integrate the exception into a practical application or amount to significantly more than the exception itself.
The following rejections are made under 35 U.S.C. § 101 for the presently pending claims. The eligibility analysis follows the two‑step process set forth in Mayo/Alice and USPTO guidance (see MPEP 2106).
Step 1 — Statutory category
The pending claims are directed to compositions (composition of matter) comprising oils or extracts of Anisomeles species and related constituents (hexahydrofarnesyl acetone, farnesyl acetone) together with delivery vehicles, fixatives, or concentration ranges. Accordingly, the claims are drawn to statutory subject matter categories (composition of matter and article of manufacture), and the eligibility analysis proceeds to the judicial-exception inquiry per MPEP § 2106.
Step 2A — Prong One: Is a judicial exception recited?
The composition claims require as a material element an oil of an Anisomeles species that comprises hexahydrofarnesyl acetone (HFA), enriched/refined Anisomeles extracts, or added naturally occurring farnesyl-type compounds. The specification expressly identifies HFA and farnesyl acetone as naturally occurring constituents of Anisomeles oil (see specification [0031]–[0034], [0047]–[0053], Table 1) and describes routine hydrodistillation and solvent extraction methods for obtaining such oils ([0076]–[0080], [0081]–[0083]). These materials and constituents are therefore products of nature or naturally occurring substances.
Because the claims recite nature-based materials (plant oil and plant-derived constituents), the claims implicate a judicial exception (product of nature / natural phenomenon). See Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013); MPEP § 2106.04(c).
Step 2A — Prong Two: Does the claim integrate the exception into a practical application? (Mayo/Alice / MPEP § 2106)
The additional claim recitations — for example, “a delivery vehicle” (aqueous aliphatic alcohol, cream, gel, spray, roll-on, etc.; see [0043]–[0046], [0063]), numeric concentration limits for components ([0038]–[0040], [0052], [0061]), and the functional utility of “repelling insects” — are conventional formulation features, known methods of delivery, and an intended use of the natural product. The specification discloses these elements as standard carriers, routine formulation types, and ordinary extraction/enrichment steps.
Under MPEP § 2106.05(d)–(f) and controlling case law, mere combination of a natural product with conventional carriers, routine concentration/optimization, or statements of intended use does not integrate a judicial exception into a practical application in the manner required to avoid exclusion. See Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948); Myriad, 569 U.S. at 590–91.
Step 2B — Does the claim recite “significantly more” than the judicial exception?
To be patent eligible, claims that recite a judicial exception must add inventive concepts or additional elements that amount to “significantly more” than the natural product itself (Alice/Mayo framework; MPEP § 2106.05). The composition claims at issue do not recite structural changes to the natural products, nor do they disclose manufacturing steps or technological features that transform the naturally occurring material into a new composition having markedly different characteristics from the materials as they occur in nature.
Specifically:
Specifying amounts or concentration ranges of naturally occurring constituents (HFA, FA, Anisomeles oil, enriched extract) does not itself transform the natural product into a patent-eligible composition absent evidence of new structural or functional properties arising from those specific concentrations. See Myriad; MPEP § 2106.04(c).
Enrichment or concentration of natural constituents by routine extraction, adsorption, or solvent partitioning is a purification/ concentration step that does not, by itself, create a composition “markedly different” from its natural counterpart unless the Applicant demonstrates distinctive structural or functional attributes not present in nature. See MPEP § 2106.04(c)(II).
Addition of other natural products (e.g., natural fixatives) or using conventional carriers/delivery vehicles are well-understood, routine activities in formulation practice and do not amount to an inventive concept that renders the claim eligible. See MPEP § 2106.05(d).
Claim 30 does not recite structural alterations to the natural composition, nor technological or manufacturing steps that produce a composition or article having markedly different characteristics from the natural product and the conventional article. Impregnation of a conventional article with a naturally occurring oil — without recited structural transformation, unconventional processing that yields new properties, or other non-routine features — reflects ordinary, routine application and does not add an inventive concept that is “significantly more” than the product-of-nature exception.
The claims therefore lack the “significantly more” necessary to transform the judicial exception into patent-eligible subject matter.
For the foregoing reasons, the claims are rejected under 35 U.S.C. § 101 as being directed to a judicial exception (product of nature / natural phenomenon) without reciting additional elements that integrate the exception into a practical application or otherwise provide “significantly more” than the judicial exception itself.
Response to Arguments
Applicant argues that amended claim 19 is eligible under 35 U.S.C. 101 because it allegedly recites a composition having markedly different characteristics from a natural product, relying on the recited combination of Anisomeles oil with added HFA, added farnesyl acetone, or both, and on the specification’s repellency data. This argument is not persuasive.
The claims remain directed to nature-based materials, including Anisomeles oil and naturally occurring constituents such as hexahydrofarnesyl acetone (HFA) and farnesyl acetone, as well as enriched or refined plant-derived extracts. The fact that claim 19 now recites a numerical amount of Anisomeles oil and the presence of added HFA and/or farnesyl acetone does not, by itself, remove the claim from the judicial exception. The recited ingredients are still natural products or natural-product-derived materials, and the amendment does not recite a structural transformation of those materials into something markedly different from what occurs in nature.
Applicant’s reliance on test data in the specification is also unavailing. Evidence of repellency or improved performance does not establish patent eligibility where the claim remains directed to a natural product or a combination of natural products and conventional formulation features. The inquiry under 35 U.S.C. 101 is whether the claim, as a whole, integrates the judicial exception into a practical application or adds significantly more than the exception itself. Even accepting Applicant’s comparative data as true, the evidence shows at most improved repellency performance, not a structurally or functionally markedly different natural product within the meaning of MPEP § 2106.04(c). The record does not establish that the claimed composition as a whole possesses characteristics markedly different from the naturally occurring materials from which it is derived. Further, the additional recitations of a delivery vehicle, concentration ranges, and intended insect-repelling use are conventional formulation and use limitations that do not amount to significantly more.
In sum, Applicant has not shown that the amended claims recite a new composition with markedly different structural characteristics from the naturally occurring materials, nor has Applicant identified claim language that imposes a nonconventional technological solution beyond the use of natural products in conventional carriers at selected concentrations. Accordingly, the rejection under 35 U.S.C. 101 is maintained.
Claim Rejections - 35 USC § 103 – Maintained
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19, 21, 23, 26-30, 35, and 36 remain rejected under 35 U.S.C. 103 as being unpatentable over Kenichi et al. (EP1483965A1; July 2, 2003), as evidenced by NIST (https://webbook.nist.gov/cgi/cbook.cgi?ID=C68607885; accessed 4/1/2026), in view of Pandey et al. (J Food Sci Technol. 2014 Dec;51(12):4066-71; Epub 2012 Dec 4).
Independent claim 19 recites an insect repellent composition comprising an amount of oil of Anisomeles species of at least about 5% to about 50% by weight of the composition, a delivery vehicle, and that the oil comprises hexahydrofarnesyl acetone (HFA) and/or that the composition includes added HFA, added farnesyl acetone, or both.
Kenichi teaches pest repellent compositions comprising farnesylacetone-type compounds of formula (I) as active ingredients, where the relevant bond may be a single bond or a double bond (see [0009]-[0012]), and teaches use of such actives in a broad range of delivery vehicles and formulation types, including liquids, emulsions, creams, aerosol forms, powders, sheets, and other preparations (see [0013]). Kenichi teaches use of farnesylacetone-type repellents and further discloses use of phytone in repellent examples (see p. 16, Example 6; p. 17, Example 10). The NIST Chemistry WebBook identifies phytone as hexahydrofarnesyl acetone (HFA). Thus, Kenichi teaches use of HFA as an insect repellent active.
Kenichi further teaches applying or impregnating such repellent compositions into various articles and substrates, including cloth, fiber products, sheets, nonwoven materials, bedding, carpets, wood, and other household or wearable materials, for repellency against a broad range of pests including mosquitoes, cockroaches, ants, flies, and termites (see [0044], [0052]).
Kenichi does not teach oils from Anisomeles species.
Pandey teaches that essential oil of Anisomeles indica exhibits substantial insect repellency against C. chinensis and C. maculatus (see pp. 4067-4068, insecticidal bioassay, Table 1). Pandey also teaches that essential oils are obtained by hydrodistillation and that biological efficacy was evaluated across differing concentrations in the study, reflecting that repellency/insecticidal activity is concentration dependent and that oil loading is a variable affecting performance (see pp. 4067-4068, essential oil extraction; Table 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the Anisomeles oil of Pandey with the known HFA repellent taught by Kenichi, because both references teach insect-repellent or insect-control natural actives, and combining known repellency actives in a single composition would have predictably provided at least an additive repellent effect. In particular, the recited inclusion of Anisomeles oil together with HFA and/or farnesyl acetone amounts to the predictable use of known repellency ingredients according to their established functions.
The amended recitation of “at least about 5% to about 50% by weight” for the Anisomeles oil, as well as the recitation of added HFA and/or added farnesyl acetone, would have been the result of routine optimization of result-effective variables. The prior art establishes that repellency efficacy depends on the amount and identity of active ingredients, and that concentration variation is a recognized parameter affecting performance. Kenichi teaches repellent actives in different formulation types and delivery vehicles, which necessarily entails selection of active loading. Pandey teaches that Anisomeles oil is itself an active repellent material and that efficacy is evaluated at differing concentrations. Thus, varying the amount of Anisomeles oil within a practical formulation range, and further including HFA and/or farnesyl acetone at workable levels, would have been within the level of ordinary skill in the art and would have required no more than ordinary experimentation. Where the prior art recognizes that a property depends on concentration and teaches variation of that parameter, discovering an optimum or workable value is ordinarily the result of routine optimization of result-effective variables, absent a showing of criticality or unexpected results for the claimed range. See MPEP §§ 2144.05 and 2144.01. Applicant has not shown that the claimed range of about 5% to about 50% by weight for Anisomeles oil is critical, that it produces unexpected results, or that it is otherwise outside what would have been expected from routine formulation optimization.
Accordingly, claims 19, 21, 23, 26-30, 35, and 36 would have been obvious over Kenichi in view of Pandey.
Claims 24 and 25 remain rejected under 35 U.S.C. 103 as being unpatentable over Kenichi et al. (EP1483965A1; July 2, 2003), as evidenced by NIST (https://webbook.nist.gov/cgi/cbook.cgi?ID=C68607885; accessed 4/1/2026), in view of Pandey et al. (J Food Sci Technol. 2014 Dec;51(12):4066-71; Epub 2012 Dec 4), as applied to claim 19 above, and in further view of Unpaprom et al. (Chiang Mai J. Sci. 2015, 42(1):148-155).
The teachings of Kenichi and Pandey are set forth above. Neither Kenichi nor Pandey expressly teach oil from Anisomeles malabarica.
Unpaprom teaches that Anisomeles malabarica is an active mosquito-control botanical, specifically showing that methanolic leaf and inflorescence extracts exhibit larvicidal activity against Anopheles stephensi; and that efficacy was evaluated across a range of concentrations, e.g., 20-100 ppm (see pp. 151-152, Results and Discussion; Tables 1, 2). Unpaprom therefore provides additional evidence that Anisomeles malabarica was recognized in the art as an insect-control active and that varying its concentration to achieve desired efficacy was routine.
Accordingly, it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to select Anisomeles malabarica as an obvious Anisomeles species for use in the repellent compositions suggested by Pandey, because Unpaprom provides reason to expect that this species would be useful for mosquito control. It further would have been obvious to combine that known Anisomeles-derived repellent ingredient with the known HFA repellent active of Kenichi, since both references teach known repellency actives that would have predictably provided additive or enhanced repellent effects when combined.
To the extent that claims 24 and 25 recite particular concentrations or relative amounts of the HFA compound and/or Anisomeles malabarica oil, those amounts would have been obvious through routine optimization of result-effective variables. Kenichi teaches varying active loading of farnesylacetone-type repellents, and Unpaprom teaches that Anisomeles malabarica-derived actives were evaluated at different concentrations for mosquito-control efficacy. The claimed concentration selections therefore represent ordinary optimization of a known parameter affecting a known result, namely repellency efficacy. Absent a showing of criticality or unexpected results, arriving at workable or optimum concentrations for the combined composition would have been within the ordinary skill in the art. See MPEP §§ 2143 and 2144.05.
Accordingly, claims 24 and 25 would have been obvious over Kenichi in view of Pandey and Unpaprom.
Response to Arguments
Applicant’s arguments have been fully considered but are not persuasive. Although Applicant relies on comparative data in the specification, the present record does not include sufficient objective evidence showing that the asserted results would have been unexpected to a person of ordinary skill in the art in view of the teachings of Kenichi, Pandey, and Unpaprom. The prior art already teaches that farnesylacetone-type compounds, including HFA/phytone, are effective pest-control actives, that such activity is concentration dependent, and that these compounds may be used in a variety of conventional delivery vehicles and formulations. The prior art also teaches that Anisomeles oils exhibit insect-control activity. Accordingly, combining the known Anisomeles oil with the known HFA/farnesylacetone repellent would have been expected to yield at least an additive or predictable repellent effect, absent persuasive evidence to the contrary. See MPEP §§ 2143, 2143.01, and 2144.
Applicant’s argument that the claimed composition shows improved repellency over the individual components is not sufficient, by itself, to overcome the rejection. A showing of improved performance does not establish nonobviousness unless the improvement is shown to be unexpected, critical to the claimed scope, and supported by evidence commensurate in scope with the claims. See MPEP § 716.02(a) and § 716.02(d). Here, Applicant has not provided objective evidence demonstrating that the claimed combination achieves more than the expected effect of combining two known repellency actives. The comparative data, while indicating performance differences among tested formulations, does not establish that those differences would have been surprising to one of ordinary skill in the art, particularly in view of the art’s teachings that repellency efficacy varies with concentration and formulation. Nor does Applicant provide persuasive evidence that the claimed ranges or combinations are critical, or that the results are outside the ordinary expectations of formulation optimization. See MPEP §§ 2144.05 and 716.01(c).
Applicant further argues that there was no reasonable expectation of success in combining the cited references because the references address different pests and because repellency can vary by species. This argument is not persuasive. The relevant inquiry is whether a person of ordinary skill in the art would have had a reasonable expectation that the combination of known repellent actives would function for their intended pest-control purpose, not whether every species-specific outcome was expressly exemplified in the references. Both references teach repellency against pests, and the cited art supports the general proposition that known repellency actives may be combined in conventional formulations to obtain useful pest-control compositions. That the exact combination was not expressly disclosed does not defeat obviousness where the combination would have been predictable to try and routine to optimize. See MPEP §§ 2143, 2143.02, and 2144.05.
To the extent Applicant relies on attorney statements characterizing the comparative data as “remarkable,” “significantly higher,” or otherwise unexpected, such statements are not evidence and cannot substitute for objective proof. See MPEP § 716.01(c). Likewise, unsupported assertions that the claimed results are superior do not outweigh the strong prima facie case of obviousness established by the prior art. In sum, Applicant has not shown that the comparative data reflect more than the expected additive effect of known repellency ingredients, nor has Applicant demonstrated a sufficient nexus between any alleged improvement and the full scope of the pending claims. Accordingly, the rejections under 35 U.S.C. 103 are maintained.
Conclusion
No claims are 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.
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/CHRISTOPHER M BABIC/ Supervisory Patent Examiner, Art Unit 1633
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