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) 1-11 in the reply filed on March 26, 2026 is acknowledged.
Claim(s) 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-11 are examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 15, 2024 and March 26, 2026 are being considered by the examiner. However, the foreign patent document #2 in IDS from March 26, 2026 were lined through and not considered. The information disclosure statement filed March 26, 2026 fails 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. It has been placed in the application file, but the information referred to therein has not been considered.
The signed IDS forms are attached with the instant office action.
Specification
The disclosure is objected to because of the following informalities:
On page 5 at the top of the page, “In the drawing:” should read “Brief Description of The Drawings:”
Appropriate correction is required.
The abstract of the disclosure is objected to because it is more than one paragraph. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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) 2-4 and 8-11 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 2 recites 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 2 recites the broad recitation “a content of…”, and the claim also recites “preferably” and “particularly preferably” which are the narrower statement of the range/limitation. The claim(s) are 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 3 is indefinite because there is a lack of antecedent basis for the limitation “the lecithin” as recited in line 1 of the claim.
Claim 4 is indefinite because there is a lack of antecedent basis for the limitation “the lecithin” as recited in line 2 of the claim.
Claims 8-11 recite the broad recitation “a range of…”, and the claims also recite “preferably” and “more preferably” which are the narrower statement of the range/limitation. The claim(s) are 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 11 is indefinite because there is a lack of antecedent basis for the limitation “the content of lecithin” as recited in line 1 and 2 of the claim.
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(s) 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A cosmetic composition comprising the aerial plant parts of the royal fern, water, polyhydric alcohols and a liposomally (e.g. lecithin) encapsulated form of the three ingredients of claim(s) 1-11 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 claim 11 is drawn to a cosmetic composition that comprises the royal fern (e.g. Osmunda regalis), water, polyhydric alcohols and a liposomally (e.g. lecithin) encapsulated form of the three ingredients. Royal fern is a naturally occurring plant, water, polyhydric alcohols (e.g. glycerol and pentylene glycol) 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 (e.g. maceration) 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 the royal fern (e.g. Osmunda regalis), water, polyhydric alcohols and a liposome (e.g. lecithin) 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 composition. 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 the royal fern (e.g. Osmunda regalis), water, polyhydric alcohols and a liposome (e.g. lecithin) 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goluke (EP 2752183 A1 – English translation provided).
Goluke teaches auxiliaries and concomitants according to the invention may be those which are conventionally used in cosmetic compositions, such as, for example, water, mono- or polyhydric alcohols (page 3). Goluke teaches [that] it is advantageous if the proportion of fern extracts in the natural product complex is present [in] liposomally encapsulated form (page 2). Goluke teaches [that the] cosmetic product with organic natural product complex comprises: the natural product complex consisting of an extract from one or more ferns [such as] Osmunda regalis ([e.g. royal fern]) (abstract). Goluke teaches the cosmetic according to any one of claims 1-6, characterized in that the proportion of ferns in the range of 0.1 - wt .-% is 8 with respect to the total weight of the cosmetic (claim 7).
The Goluke reference does not specifically teach that all of the three ingredients (e.g. the royal fern, water and polyhydric alcohols) are a first ingredient and that as a second ingredient, all of the first ingredients are liposomally encapsulated. In addition, although Goluke teaches the extract of royal fern, that does not negate the fact that in order to acquire the desired components from the royal fern plant to use within a first ingredient, there would have to be a form of extraction present. Lastly, the Goluke reference does teach that the composition containing the royal fern can be within a liposomal form, therefore, the addition of water and polyhydric alcohols would naturally occur in order to achieve a more efficient form of encapsulation.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Goluke (EP 2752183 A1 – English translation provided) in view of Berthon (FR 2876032 A1 – English translation provided) and Fernandez (EP 2536815 B1).
The teachings of Goluke are above.
Goluke does not teach that the second ingredient contains a content of 1 to 10% by weight, preferably of 3 to 7% by weight, particularly preferably of 5% by weight of lecithin (as stated in claim 2 of the present invention). Goluke does not teach that the lecithin is a sunflower lecithin (as stated in claim 3 of the present invention). Goluke does not specifically teach a proportion of 20% by weight of the first ingredient is present liposomally encapsulated in the lecithin of the second ingredient (as claimed within claim 4 of the present invention). Goluke does not teach that the polyhydric alcohols comprise pentylene glycol (as stated within claim 5 of the present invention). Goluke does not teach the aerial plant parts of the royal fern comprise the stalk and the leaves of the plant and does not teach that the first ingredient is prepared in a maceration process (as stated within claims 6 and 7 of the present invention, respectively). Goluke does not teach [that the] first ingredient comprises a range from 0.01 to 1.0% by weight, preferably a range from 0.1 to 0.8% by weight, more preferably 0.5% by weight (as stated within claim 8 of the present invention). Goluke does not teach the content of the second ingredient comprises a range from 0.01 to 1.0% by weight, preferably a range from 0.1 to 0.8% by weight, more preferably 0.5% by weight (as stated within claim 9 of the present invention). Goluke does not teach the particle size of the second ingredient is in a range from 50 to 300nm, preferably in a range from 100 to 250nm, more preferably 200nm (as stated within claim 10 of the present invention). Goluke does not teach the content of lecithin comprises a range from 0.01 to 0.5% by weight, preferably from 0.02 to 0.1% by weight, more preferably 0.025% by weight (as stated within claim 11 of the present invention).
Berthon teaches a cosmetic or dermatological product that contains the extract of [the] aerial parts of ferns (claim(s) 1 and 2). Berthon teaches [that] these properties are due to the presence of active molecules extracted either from the roots and/or the rhizome for the underground parts, or for the aerial parts of the stem and/or leaf (page 2). Berthon teaches the use of Osmunda regalis (page 3). Berthon teaches the cosmetic or dermatological compositions according to the invention may also take the form of a lotion or solution in which the extract is in encapsulated form. The microspheres according to the invention may for example consist of fatty substances, agar and water. The extract can be incorporated into liposome, glycosphere-type vectors in chylomicrons, macro, micro, nano-particles as well as macro-, micro- and nanocapsules (page 5). Berthon teaches [to] grind the dry plant material to a particle size of less than 1 mm (page 3).
Fernandez teaches a composition of ingredients [that contains 10% in weight of lecithin] (pages 16-17, under ‘example 1’). Fernandez teaches in a particular embodiment, the phospholipid of the liposomes of this invention is a natural or synthetic phosphoglyceride [such as] natural lecithins [from] sunflower (page 3, paragraph 0012).
The cosmetic composition as taught by Goluke can be modified to include that the royal fern (e.g. Osmunda regalis) portion that can be used are portions from the aerial parts of the stem and/or leaf as taught by Berthon, in which, the royal fern plant can be subjected to maceration also taught by Berthon. In addition, the glycerol as taught by Goluke can also include pentylene glycol as taught by Fernandez that would comprise the two polyhydric alcohols used within the first ingredient. In addition, Goluke’s composition can be modified to further include that the liposomal encapsulation is a natural lecithin, such as a sunflower lecithin as taught by Fernandez. One of ordinary skill in analytical chemistry would reasonably expect that maceration is another form of an extraction that can be used in order to retrieve desired compounds necessary for Goluke’s cosmetic composition. Furthermore, one would reasonably expect to use the combination of references in order to create the ideal cosmetic composition that would include a first ingredient and a second ingredient.
Regarding claim(s) 4 and 8-11, the aforementioned references combined does not teach a proportion of 20% by weight of the first ingredient is present liposomally encapsulated in the lecithin of the second ingredient, the content of the first ingredient comprises a range from 0.01 to 1.0% by weight, preferably a range from 0.1 to 0.8% by weight, more preferably 0.5% by weight, the content of the second ingredient comprises a range from 0.01 to 1.0% by weight, preferably a range from 0.1 to 0.8% by weight, more preferably 0.5% by weight, the particle size of the second ingredient is in a range from 50 to 300nm, preferably in a range from 100 to 250nm, more preferably 200nm and that the content of lecithin comprises a range from 0.01 to 0.5% by weight, preferably from 0.02 to 0.1% by weight, more preferably 0.025% by weight. However, 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 cosmetic composition. Varying the concentration of ingredients within a cosmetic 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. One of ordinary skill in the art would reasonably expect to experiment with the content percentages of the first and second ingredients along with optimizing the particle size of the second ingredient in order to create the ideal liposomal encapsulation of the 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.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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