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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claim(s) 13-22 in the reply filed May 22, 2026. Claim(s) 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on May 07, 2024 are being considered by the examiner. The signed IDS form is attached with the instant office action.
Specification
The disclosure is objected to because of the following informalities:
Beginning on page 10 of the specification, applicant should have a header name for the figures/drawings (Fig. 1A-C and 2) such as “Brief Description of the Drawing(s)”. In addition, applicant should include a short description of each of the drawings within the specification.
The abstract of the disclosure is objected to because it is not a single paragraph preferably
within the range of 50 to 150 words in length. The abstract of the present invention consists of two separate paragraphs. A corrected abstract of the disclosure
within the preferred ranges disclosed is required. See MPEP § 608.01(b).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 14-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim(s) 14-22 are indefinite because the applicant references an incorrect claim; within claim(s) 14-22, applicant continuously refers back to “claim 1”. Claim 1 has been canceled and therefore, examiner will interpret dependent claim(s) 14-22 as dependent on independent claim 13. Applicant is required to state on the record the independent claim upon which claim(s) 14-22 depend on.
Claim 16 is indefinite because it is unclear what “anti-pollution” means; in addition; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim 17 is indefinite because it is directed to a non-therapeutic “use”. “Use” type claims are not a statutory category of invention. Thus, it is unclear if the claims are a method or a composition. Thus, the metes and bounds of the claim are unclear. For the sake of examination, the claim is examined as a composition with an intended use because this is the broadest reasonable interpretation of the claim and because the claim does not contain any active method steps. In addition, it is unclear what is considered a “non-therapeutic” use in comparison with “therapeutic” use. It is unclear what limitations are meant to be implied by “non-therapeutic”. Moreover, it is unclear what “light stabilizer” means; the specification does not list the exact meaning of the phrase. Lastly, “in particular” is considered indefinite. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Thus, the metes and bounds of the claim are unclear.
Claim 19 is indefinite because it recites “in particular”. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the
broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP §2173.05(c).
In the present instance, claim 20 recites the broader limitation “of more than 0.5% by weight”, and the claim also recites “in particular 1-2% by weight or 1-5% by weight in dry weight” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, “in particular” is considered indefinite. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 22 is indefinite because it is unclear what “auxiliary substances” means. In addition; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is directed to a “use” type claim which is a non-statutory category of invention.
Claim(s) 13-16 and 18-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A cosmetic composition comprising extracts of Gentiana, Leontopodium, and Centella of claim(s) 13-16 and 18-22 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims 13-16 and 18-22 are drawn to a composition that comprises extracts from Gentiana, Leontopodium, and Centella. In addition, applicant's claims in claim(s) 21 and 22 further recite the combination of an agent (e.g. an antioxidant like ascorbic acid), auxiliary substance (e.g. ascorbic acid) and additives (e.g. sorbic acid). Gentiana, Leontopodium and Centella are naturally occurring plants, ascorbic acid (e.g. vitamin C) and sorbic acid are also naturally occurring. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature- based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties”
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. In addition, the closest naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication that mixing the following ingredients together such as extracts from Gentiana, Leontopodium, and Centella, an agent (e.g. an antioxidant like ascorbic acid), auxiliary substance (e.g. ascorbic acid) and additives (e.g. sorbic acid) as commensurate in scope with the stated claims changes the structure, function, or other properties of the components in any marked way in comparison with the closest naturally occurring counterpart. Thus, the claims are drawn directly to a product of nature. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use as a cosmetic. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. In this case, the additional element is the mixing of the claimed ingredients. Mixing extracts from Gentiana, Leontopodium, and Centella, an agent (e.g. an antioxidant like ascorbic acid), auxiliary substance (e.g. ascorbic acid) and additives (e.g. sorbic acid) does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
In addition, applicant's intended use of a cosmetic composition is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Claim(s) 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Afornali (WO 2020087146 A1 – English translation provided).
Afornali teaches a formulation comprising at least one medicinal plant, or part or extract thereof, one or more extractor agents and one or more pharmaceutically or cosmetically acceptable excipients that provide a plant extract (plant derivative) that is rich in bioactive substances for regenerating the skin, dermal mucous membranes and the like (abstract). Afornali teaches [that the] formulation also provides cosmetic products for topical application intended to ensure the protection, maintenance and natural balance of the skin, dermal mucous membranes and the like (abstract). Afornali teaches [that the composition can include the plant extracts of] Centella, Gentiana and Leontopodium (claim 2). Afornali teaches [that the composition can include] kaempferol ([e.g. an antioxidant, auxiliary substance and an additive]) (paragraph 0054). Afornali teaches [that] the extracting agents are selected from among, but are not limited to: water, ethanol, ethers, methanol (paragraph 0050). Afornali teaches that the formulation can comprise 2 to 6% of a medicinal plant, part or extract thereof (claim 14).
The Afornali reference does not teach that the extracts of Gentiana : Leontopodium : Centella are present in a ratio of 2.5-4:0.5-1:0.5-1 (w/w/w) in dry weight) (as stated within claim 18 of the present invention). In addition, the Afornali reference does not explicitly teach an anti-ageing composition, an anti-wrinkle composition, an anti-pollution composition and a light stabilizer for non-therapeutic use, in particular a blue light and IR, UV stabilizer, comprising the cosmetic composition according to claim 1 (as stated across claim(s) 14-17 within the claims of the present invention).
Regarding claim(s) 13 and 18, although the cosmetic composition as taught by Afornali does not include the ratios of Gentiana, Leontopodium and Centella (as stated within claim 18 of the present invention) in the amounts as claimed by the applicant and does not specifically teach that the cosmetic composition comprises more extract in percentage by weight of Gentiana than Leontopodium or Centella (as stated within claim 13 of the present invention), as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. Also, one of ordinary skill in the art would reasonably expect that if a composition can comprise more than one plant extract, it is already known in the art to produce a composition that can possess a higher or lower concentration of plant extract(s) (in this case, a higher concentration of Gentiana and lower concentrations of Leontopodium or Centella) within a product given that the end goal is to provide the ideal cosmetic composition that would assist in anti-ageing, anti-wrinkle, anti-pollution, for protecting skin against blue light and in general, as an all-around cosmetic composition for use on the skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U 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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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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