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 .
Examiner's Note
Applicant is reminded that claim amendments must comply with 37 CFR 1.121(c) (see also MPEP 714 c). In the interest of compact prosecution, the amended claims have been accepted, but the Examiner notes the following: canceled claim 17 should be listed by only the claim number and status identifier without presenting the text of the claim.
Applicant is advised that any future amendments that are not in compliance with 37 CFR 1.121 will result in the mailing of a notice of non-compliant amendment.
Status of the Claims
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/09/2025 has been entered.
Claims 10-11 and 17 are cancelled.
Claims 1-8 are withdrawn.
Claims 9, 12-16, and 18 are under current examination.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 07/07/2025 has been considered by the Examiner. The Examiner notes that no copies of foreign references CN 101485647 B, JP 2015091772 A, and WO 2010086717 A2 were provided, and accordingly, these references were not considered.
Claim Interpretation
Claim 9 recites “A method of cosmetic treatment comprising the step of topically applying to the skin, the scalp or the appendages a composition comprising a physiologically acceptable medium and, as an active substance, a solubilized patchouli extract obtained by a process comprising the following steps:
a) harvesting the upper part of the patchouli aerial parts and then drying and grinding or cryogenically grinding;
b) performing a supercritical carbon dioxide extraction in the presence of a polar co-solvent, said polar co-solvent being ethanol at a concentration of between 50 and 96% volume/volume percentage;
c) recovering a crude patchouli extract and decolouring in the presence of activated carbon and filtering before the co-solvent is evaporated;
d) solubilizing the crude extract obtained in step c) in a saturated or unsaturated, linear or branched fatty alcohol solvent comprising 8 to 30 carbon atoms to obtain the crude extract concentration in the final solubilized extract between 2 and 6% by weight of the total weight of the solubilized extract,
for care of the skin, the scalp and the appendages, wherein the said solubilized patchouli extract has at least one of the properties selected among: combatting the signs of skin ageing, reinforcing the barrier function, and any combinations thereof, wherein the crude extract of patchouli leaves obtained by the method recited from steps a) to c) comprises 60 to 70% weight/weight percentage of volatile compounds mainly of sesquiterpenes and sesquiterpene alcohols; from 26 to 32% weight/weight percentage of lipid compounds in particular fatty acids, phytosterols, triterpenes, acyl glycerides, and lastly from 3 to 4% weight/weight percentage of phenolic compounds, primarily flavonoids.”
The solubilized patchouli extract recited in claim 9 is a product-by-process limitation. Per MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Here, the product defined by the process of claim 9 is a patchouli extract solubilized in a saturated or unsaturated, linear or branched fatty alcohol solvent comprising 8 to 30 carbon atoms wherein the extract comprises 60 to 70% weight/weight percentage of volatile compounds mainly of sesquiterpenes and sesquiterpene alcohols; from 26 to 32% weight/weight percentage of lipid compounds in particular fatty acids, phytosterols, triterpenes, acyl glycerides, and lastly from 3 to 4% weight/weight percentage of phenolic compounds, primarily flavonoids.
The method of instant claim 9 is therefore interpreted as a method of cosmetic treatment comprising topically applying to the skin, the scalp or the appendages a composition comprising a patchouli extract having the above structural limitations and a saturated or unsaturated, linear or branched fatty alcohol solvent comprising 8 to 30 carbon atoms (which is a physiologically acceptable medium). Claims 14-16 further limit the process of obtaining a patchouli extract and do not limit the patchouli extract itself, absent evidence to the contrary.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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 9, 12-16, and 18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 9, the phrase "in particular" in line 22 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 12-16 and 18 are rejected under 35 U.S.C. 112(b) by virtue of their dependence on indefinite claim 9 and failure to cure the deficiency noted above.
Claim Rejections - 35 USC § 103
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.
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 9, 12-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 108096315A, published June 1, 2018; of record), hereafter “Li” in view of Muttucumaru (“Alcohol-should your skincare be teetotal?” August 20, 2017, https://www.getthegloss.com/beauty/skincare/alcohol-should-your-skincare-be-teetotal; of record), Donelian et al. (“Comparison of extraction of patchouli (Pogostemon cablin) essential oil with supercritical CO2 and by steam distillation” J. Supercritical Fluids 2009, 48, 15-20; included on IDS submitted 07/29/2021), hereafter “Donelian”, and Soh et al. (“A study of essential oil extraction and antioxidant activity of patchouli (Pogostemon cablin) using supercritical carbon dioxide” ON12 2018, 1-8; of record), hereafter “Soh”, as evidenced by Buschhaus et al. (“Chemical Composition of the Epicuticular and Intracuticular Wax Layers on Adaxial Sides of Rosa canina Leaves” Annals of Botany 2007, 1-8).
As set forth above, the process of obtaining a patchouli extract set forth in instant claims 9 and 14-16 are interpreted as product-by-process limitations which do not materially limit the patchouli extract beyond the structural features claimed.
Regarding instant claims 9 and 14-16, Li teaches an anti-acne compound medicine comprising patchouli extract dissolved in a mixture of an oil phase, emulsifier, and co-emulsifier (abstract, claim 1). The patchouli extract can be extracted by supercritical carbon dioxide extraction (claim 2, paragraph [0012]). The compound medicine can be prepared into a water solution, emulsion, gel, cream etc. for use in anti-acne skin care products and/or cosmetics (abstract). Li teaches the application of the medicine to ear skin (paragraphs [0061]-[0062]). Li teaches that the occurrence of acne is the result of multiple factors including bacterial infection (paragraph [0004]), and that the anti-acne compound containing patchouli extract is antibacterial (paragraphs [0034]-[0035] and [0052]-[0058]). Following application, reductions in the amount of acne and the keratinization of the sebaceous gland ducts of the hair follicles of the skin occurred, promoting the healing of the acne and the repair of the affected skin (paragraph [0066]).
Per the instant specification at pg. 18, “The expression "improving the barrier function" means that the skin's protective properties against external aggressions (UV radiation, pollution, microorganisms, etc.) are improved.” As the anti-acne compound containing patchouli extract is antibacterial (improves protective properties against microorganisms), reduces acne and keratinization of the sebaceous gland ducts, and promotes repair of affected skin, it is interpreted that the patchouli extract has the property of reinforcing the barrier function of the skin.
Regarding instant claim 18, Li teaches that the compound medicine contains 1-10 wt.% of patchouli extract.
Li does not teach the inclusion of a saturated or unsaturated, linear or branched fatty alcohol solvent comprising 8 to 30 carbon atoms.
Muttucumaru teaches that use of certain alcohols in skincare and cosmetics, such as ethyl alcohol, denatured alcohol, methanol, isopropyl alcohol, SD alcohol, and benzyl alcohol, can cause dryness that can be a problem for acne-prone skin and result in oil glands going into overdrive (pg. 2-3 “2. Some types can be problematic for the acne-prone”). They further teach that fatty alcohols such as cetyl (C16), stearyl (C18), and cetearyl (mixture comprising C16 and C18) can help hydrate skin and are used as thickening agents and emulsifiers in skincare products (pg. 2, “1. Some can be good for dry skin types”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the anti-acne compound medicine of Li with the fatty alcohols taught by Muttucumaru. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate an emulsifier that is known to hydrate skin and avoid dryness that can be problematic for acne-prone skin, as suggested by Muttucumaru. There is a reasonable expectation of success as Li teaches an anti-acne compound medicine which includes an emulsifier and co-emulsifier that can be used in anti-acne skin care products and/or cosmetics.
Li does not teach that the patchouli extract comprises from 60 to 70% weight/weight percentage of volatile compounds, from 26 to 32% weight/weight percentage of lipid compounds, and from 3 to 4% weight/weight percentage of phenolic compounds, as required by instant claim 9.
Donelian teaches the extraction of patchouli essential oil with supercritical carbon dioxide (scCO2) (abstract). Patchouli plants were collected and the leaves were collected manually, dried in an oven, and the dried leaves were ground with a knife grinder (pg. 16, “2.1 Material”). The patchouli plant material was extracted with supercritical CO2 and the extract samples collected (pg. 17, “2.3 Supercritical extraction procedure”). Donelian teaches that volatile compounds were identified at between 75.89 and 80% in the extract (Table 3), with the majority of these comprised of sesquiterpenes and sesquiterpene alcohols, particularly patchoulol, α-guaiene, δ-guaiene, and α-patchoulene. Donelian further teaches that extraction using supercritical carbon dioxide shows better results in terms of yield and oil quality than steam distillation and offers the advantage of not promoting the decomposition of possibly thermolabile compounds (pg. 19, “4. Conclusions”). Donelian further teaches that lipid components such as cuticular waxes are extracted with the oil (pg. 18, column 2, paragraph 4), indicating that lipidic components can make up the remainder of approximately 20-24.11% of patchouli extract obtained by supercritical CO2 extraction. As evidenced by Buschhaus et al., cuticular waxes comprise components such as fatty acids (“Introduction”, paragraph 3), consistent with the lipid compounds of the instant invention. Donelian further teaches that the temperature and pressure can be adjusted, leading to a change in patchoulol present (pg. 18, column 2, paragraph 4), the desired active principle of patchouli oil (pg. 18, column 1, paragraph 2), and a change in the total amount of volatile compounds extracted (see Table 3).
Soh teaches a study investigating the extraction of patchouli oil using supercritical carbon dioxide (abstract). The extract yielded antioxidant activity with total phenols in the range of 3.41 to 3.95% and 1.869 to 2.756 mg GAE/g respectively, which were higher than steam distillation (abstract, Table 1). Soh teaches that high temperatures used in steam distillation are detrimental to heat sensitive compounds resulting in a different flavor profile (“Introduction”, paragraph 2). Soh further teaches the supercritical extraction offers a selective extraction which can be targeted towards recovering compounds of interest by changing operating parameters such as pressure (Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art to modify the patchouli extract in the method of Li in view of Muttucumaru with the amounts of volatile compounds, lipid compounds, and phenolic compounds suggested by Donelian and Soh. The amounts of Donelian and Soh are interpreted as close to those instantly claimed, and the prior art further suggests optimization of the supercritical carbon dioxide extraction conditions to achieve an extract with a desired amount of target compounds that is advantageously of high quality (as suggested by Donelian) and has antioxidant activity (as suggested by Soh). From MPEP 2144.05 I., “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. " The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."), and from MPEP 2144.05, “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. There is a reasonable expectation of success as Li teaches the use of patchouli extract obtained by supercritical CO2 extraction that contains volatile components such as patchouli alcohol and patchouli ketone (claims 2-3), and that the anti-acne medicine used in the method comprises an antioxidant (claim 1).
The recitations of instant claim 9 of “for care of the skin, the scalp and the appendages”, instant claim 12 “for increasing the expression of CB2 endocannabinoid receptors in the skin”, and instant claim 13 “for decreasing the expression of TRPV1 endocannabinoid receptors in the skin, after UVB irradiation” characterize the benefit or result of the claimed method and do not materially limit the claimed method step. As the modified Li renders obvious the active method step of applying to the skin a composition comprising patchouli extract and a saturated or unsaturated, linear or branched fatty alcohol solvent comprising 8 to 30 carbon atoms for care of the skin, the method will necessarily result in the above properties, absent evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 06/09/2025 have been fully considered.
Regarding the claim rejections under 35 U.S.C. § 103, Applicant argues that Li fails to teach or suggest several features of the presently claimed method, and that the other cited references fail to cure Li’s deficiencies. Specifically, Applicant argues that Li does not teach that:
the patchouli extract has the properties of combatting the signs of skin ageing or reinforcing the barrier function,
the patchouli extract is obtained from leaves, using a supercritical CO2 extraction in the presence of ethanol as a polar co-solvent at a concentration of between 50 and 96% (volume/volume), or
the crude extract of patchouli leaves obtained by the method recited from steps a) to c) comprises: 60 to 70% of volatile compounds mainly of sesquiterpenes and sesquiterpene alcohols; 26 to 32% of lipid compounds in particular fatty acids, phytosterols, triterpenes, acyl glycerides, and 3 to 4% of phenolic compounds primarily flavonoid.
Applicant further argues that nothing in Donelian indicates that lipidic components can make up the remainder of the patchouli extract and that the lipid compounds recited in claim 9 are different from cuticular waxes mentioned in Donelian; the teaching of Donelian would not have prompted one of ordinary skill in the art to derive the process steps a) to d) to prepare the patchouli leaf extract as recited in claim 9. Applicant argues that the present inventors have discovered that the combination of parameters such as supercritical CO2 and ethanol at 50-96 % plays a critical role on the extracted substances which differs from conventional essential oil, as demonstrated at Example 1 when compared to Example 3 (essential oil). Applicant argues that the general conditions of the present claims are not disclosed in the prior art, as the cited prior art uses different starting materials or fails to describe the required enrichment in lipid compounds and phenolic compounds; in addition, in order for "routine experimentation" to be applied, it is required that "there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp" (Id.), and this is not described or suggested in the cited references.
The argument that Li fails to teach or suggest that the patchouli extract has the properties of combatting the signs of skin ageing or reinforcing the barrier function is unpersuasive. As set forth in the above rejection, the instant specification defines “improving the barrier function” to mean that the skin's protective properties against external aggressions (UV radiation, pollution, microorganisms, etc.) are improved (pg. 18). Li teaches that the occurrence of acne is the result of multiple factors including bacterial infection (paragraph [0004]), and that the anti-acne compound containing patchouli extract is antibacterial (paragraphs [0034]-[0035], and [0052]-[0058]). Following application, reductions in the amount of acne and the keratinization of the sebaceous gland ducts of the hair follicles of the skin occurred, promoting the healing of the acne and the repair of the affected skin (paragraph [0066]). Accordingly, it is interpreted that the patchouli extract in the method of Li has the property of reinforcing the barrier function of the skin.
Regarding the argument that Li fails to teach to perform a supercritical CO2 extraction in the presence of a polar co-solvent such as ethanol at a concentration of between 50 and 96% (volume/volume) the Examiner notes that, as set forth above, the patchouli extract recited in claim 9 is a product-by-process limitation. The claims are drawn to a method of cosmetic treatment rather than a method of obtaining a solubilized patchouli extract. Per MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The Examiner respectfully maintains that the structural limitations of the patchouli extract in the method of cosmetic treatment which is defined by the process of the instant claims are rendered obvious by the teachings of the prior art, as set forth above.
Regarding the argument that the claimed extraction parameters play a critical role on the extracted substances which differs from conventional essential oil, the Examiner maintains that evidence of record merely compares an extract obtained by the method of claim 9 (Example 1) to an oil-type extract produced by steam distillation (Example 3). However, the prior art of Li, Donelian, and Soh teach a patchouli extract extracted using supercritical CO2, and Donelian and Soh both suggest that supercritical CO2 extraction produces higher quality extracts compared to steam distillation (see abstracts, respectively). Thus, from the evidence of record, it cannot be concluded that the process of extraction recited in the instant claims has limited the extract such that it is unobvious over the extract produced by the method of the modified Li.
The arguments regarding Donelian are unpersuasive. Particularly, as set forth above, Buschhaus evidences that cuticular waxes comprise components such as fatty acids, consistent with the lipid compounds of the instant invention. Further, the instant specification at pg. 11 states that “the global lipid content (fatty acids, sterols, triterpenes, acyl glycerides, etc.) was estimated by subtraction of the volatile and flavonoid contents”, in a similar fashion to the lipid content suggested by Donelian.
The arguments that the general conditions of the claims are not disclosed the prior art and that in order for routine "routine experimentation" to be applied, it is required that "there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp" are unpersuasive. MPEP 2144.05 II B. teaches that a design or market need and a finite number of identified, predictable solutions is required to support an “obvious to try” line of reasoning. However, the Examiner is not arguing an obvious to try rationale. Rather, the Examiner asserts that prior art as a whole discloses the general conditions regarding the content of volatile compounds, lipid compounds, and phenolic compounds in patchouli extract and that supercritical CO2 parameters such as temperature and pressure can be adjusted to target desired compounds (see particularly Donelian, pg. 18, column 1, paragraph 2 and column 2, paragraph 4; Soh, “Conclusion”). Thus, it would have been obvious to one of ordinary skill in the art to achieve an extract consistent with that of instant claim 9 which is advantageously of high quality (as suggested by Donelian) with good antioxidant activity (as suggested by Soh), and this could be achieved by optimization of the supercritical carbon dioxide extraction conditions.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611