DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Election/Restriction
Applicant’s election without traverse of Group I, claims 1-12, in the reply filed on 15 July 2026, is acknowledged.
Status of Claims
The amendment, filed on 15 July 2026, is acknowledged.
Claims 13-18 are cancelled.
Claims 1-12 are pending and under consideration in the instant Office Action.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 7 October 2024, and 12 February 2025, were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs are being considered by the examiner.
Claim Objections
Claims 1-7 and 9-12 are objected to because of the following informalities:
Claims 2-7 and 10-12 recite “the topical skin composition” in the first line of each claim. Each claim depends from claim 1, which recites “topically applying to skin an effective amount of composition”. While it is apparent that claims 2-7 and 10-12 are referring to the composition recited as being topically applied in claim 1, clarity would be improved if claim 1 were amended to recite “an effective amount of a topical skin composition”.
Claim 1 recites “increased oxytocin levels” in the final line. The word “increased” should be “increases”.
Claim 3 depends from claim 1 and recites the same extracts recited in claim 1 in italics. Binomial nomenclature for the same taxon must be presented uniformly throughout the claims. Alternating between roman and italic type for the identical plant/algal names creates inconsistency as to whether the terms in claim 1 and claim 3 are intended to identify the same extracts. The claims must use one consistent typographical convention preferably italicized genus and species throughout as conventionally used in the art, as in claim 3 and as used in the specification.
Claim 4 recites “The method of claim 1, wherein the topical skin composition further comprises: Andrographis paniculata leaf extract; Aphanothece sacrum polysaccharides; and/or sodium ascorbyl phosphate.” Claim 5 recites “The method of claim 1, wherein the topical skin composition comprises: about 0.0001 to about 10% by weight of Andrographis paniculata leaf extract; about 0.0001 to about 10% by weight of Aphanothece sacrum polysaccharides; and/or about 0.0001 to about 10% by weight of sodium ascorbyl phosphate.” It is recommended that Applicant amend claim 5 to depend from claim 4 as the amount recitations in claim 5 are drawn to the further added ingredients in claim 4.
Claim 9 recites “reduce the appearance of dark spots, reduced skin discoloration, improved skin radiance and/or improved overall skin tone”. Each past tense verb should be changed to present tense to improve consistency (i.e., “reduced” should be “reduce” and “improved” should be “improve”).
Appropriate correction is required.
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.
Claims 1-2 and 8-9 are rejected under 35 U.S.C. 101 because the claimed process is directed to a natural-based product and natural phenomenon without significantly more as outlined in MPEP § 2106. Claim 1 recites the method step of increasing oxytocin levels in users by topically applying a composition comprising extracts from the Spiraea ulmaria and/or Laminaria japonica plants, which is not markedly different from the natural phenomenon exhibited by the plant extracts in their naturally occurring state. This judicial exception is not integrated into a practical application because the specification treats crude botanical/algal extracts as the active ingredients but never identifies the chemical species responsible for the recited oxytocin effect, amounting to reciting only the natural-based product exhibiting its natural phenomenon. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because it does not recite any additional manipulative step beyond application of the composition to the skin of a user. Following analysis according to MPEP § 2106, the claimed process does not recite significantly more, also known as an “inventive concept”, than the judicial exception and is therefore ineligible under 35 U.S.C. § 101. For further information on recitation of significantly more than the judicial exception, see MPEP § 2106.05(d).
Claims 2 and 8-9 are also ineligible under 35 U.S.C. § 101 for reciting natural phenomenon resulting from the recited natural-based product, which does not amount to significantly more than the judicial exception. Similarly, claim 4 recites the inclusion of the additional natural-based extract of Andrographis paniculata without identifying the chemical species responsible for the recited effects, which does not amount to significantly more than the judicial exception and is also ineligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
The MPEP states in § 2163 that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Claim 1 is not limited to a particular plant part, solvent system, extraction process, standardized marker, or commercial lot. It therefore reads on the entire genus of extracts obtainable from the two recited plants, so long as the extract, when applied, increases oxytocin. Note that the “wherein” clause is a functional limitation that further defines the genus by a biological result rather than by structure. The specification does not demonstrate possession of the recited genus. The specification in Table 1 discloses registered trademark and trade name products for each of the plant extracts. However, the specification does not provide any description or identify constituents or the active ingredients within the extracts that are responsible for the oxytocin effect. It is clear that an extract of a plant or alga is a complex mixture of undetermined constitution. The failure to identify “what exactly the active ingredients are” is therefore relevant not as a standalone demand that every molecule in a botanical extract be listed, but as evidence that the inventors have not described a structural feature that would support the full scope of claim 1.
To satisfy the written description requirement, Applicant may consider reciting the particular or specific disclosed extracts (identified plant part, solvent, and or commercial source which may clearly recite the active constituents), or identifying the active constituents, or providing a representative set of extracts plus a structure-function correlation sufficient to show possession of the genus. However, as currently presented it is deemed that the specification fails to provide adequate written description for the genus of the claim and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention. Claims 2-12 depend from claim 1, incorporate all of its limitations, and therefore are also rejected for failing to comply with the written description requirement.
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.
Claims 2-7 and 10-12 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.
Claims 2-7 and 10-12 recite “the topical skin composition”, respectively. There is no antecedent basis in claim 1, from which claims 2-7 and 10-12 depend, for the phrase “the topical skin composition”. Claim 1 never introduces a “topical skin composition”; it introduces a “composition”. The sudden appearance of the definite article “the” before an introduced, differently worded term renders the metes and bounds of claims 2-7 and 10-12 unclear. A person of ordinary skill in the art cannot determine with reasonable certainty whether “the topical skin composition” of claims 2-7 and 10-12 is intended to be the same “composition” of claim 1, a distinct composition, or some other formulation. Applicant may overcome this rejection by amending claim 1 to recite “an effective amount of a topical skin composition”.
The three ingredients recited in claim 5 (Andrographis paniculata leaf extract; Aphanothece sacrum polysaccharides; and/or sodium ascorbyl phosphate) appear for the first time in a claim that depends solely from claim 1. Those ingredients are first introduced in claim 4 (which also depends from claim 1). Because claim 5 does not depend from claim 4, there is no antecedent basis in claim 1 to claim 5 chains for treating those ingredients as already present components whose amounts are merely being further limited. Amendment of claim 5 to depend from claim 4 (or to recast the language as “wherein the composition of claim 1 further comprises...) and consistent use of the same term introduced in claim 1 “the composition” would be required to restore antecedent basis.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Banowski et al. (German Patent Application Publication No. DE 10 2011 118 016 A1, published on 2 May 2013, provided by Applicant in the IDS filed on 12 February 2025, references to English translation, hereafter referred to as Banowski).
Banowski teaches skin-applied cosmetic products, which are considered equivalent to the recited topical skin compositions, and methods which improve the “emotional well-being” of the user using oxytocin, which is considered equivalent to the recited increase of oxytocin levels (Abstract). The method for improving the mood of a user is taught to comprise the step of applying the cosmetic composition to the skin, leaving on the skin for 30 min. to “several hours”, and then removing by washing (claim 9). The instant spec. defines a leave-on composition in para. [0021] as one that “is topically applied to skin and remains on the skin for a period of time” that ranges from 5-30 minutes, 1-24 hours, overnight, or throughout the day and a rinse off composition as a product that is applied to the skin and subsequently removed or rinsed from the skin with water. Therefore, the teachings of Banowski that their method comprises topically applying the cosmetic composition, leaving on the skin for 30 min. to “several hours”, and then removing by washing is considered equivalent to a leave on product and a rinse off product.
The cosmetic product is recited as comprising monomers, oligomers, and/or polymers of amino acids (pg. 14, final para.), which in one embodiment are peptides which stimulate collagen synthesis (pg. 15, para. 4). Banowski teaches that their product also comprises at least one sebum-regulating active ingredient, which in one embodiment is an extract of Spiraea ulmaria and is present in an amount from 1x10-5-10% w/w (pg. 23, para. 2). The composition is further taught to comprise at least one vitamin (pg. 17, para. 3), which in one embodiment is the vitamin C derivative sodium ascorbyl phosphate and is present in an amount from 0.01-5% w/w (pg. 18, lines 34-38). The compositions may also comprise preservatives to protect from microorganisms and spoilage, which in some embodiments may be paraben free (pg. 9, p) preservatives). The cosmetic product is taught to be aqueous, which Banowski defines as comprising at least 50% water (pg. 3, para. 8), and may be in the form of an emulsion, hydrogel, cream, or lotion (pg. 24, para. 6-8 and claim 8). Finally, Banowski teaches that their composition may comprise skin-lightening active ingredients to assist skin-lightening, which is considered equivalent to reducing the appearance of dark spots and/or improving the overall skin tone recited in instant claim 9 (pg. 23, para. 1).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the range of quantities of Spiraea ulmaria extract, sodium ascorbyl phosphate, and water taught by Banowski which either encompass, fall within, or significantly overlap with the ranges recited in instant claims 3, 5, and 7.
Although “picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference...has no place in...a 102, anticipation rejection,” picking and choosing may be entirely proper in an obviousness rejection. In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Addressing the issue of obviousness, the Supreme Court noted that analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007)). The Court further emphasized that “[a] person of ordinary skill is…a person of ordinary creativity, not an automaton” (Id. at 1742).
The only difference between Banowski and the instant claims is that Banowski does not teach the specific combination of components as claimed in a single embodiment (e.g., a single composition comprising Spiraea ulmaria extract, sodium ascorbyl phosphate, and water in the quantities recited), or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Banowski, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP § 2141.I. Consistent with this reasoning, it would have been prima facie obvious to a person having ordinary skill in the art, prior to the effective filing date of the instant application, to have selected various combinations of the various disclosed ingredients from within the teachings of Banowski, to arrive at a method such as the one being sought.
Banowski is silent regarding skin being treated to increase oxytocin production in the skin as recited in instant claim 8. However, a recitation of the intended use of the claimed method must result in a manipulative difference between the claimed method and the prior art in order to patentably distinguish the claimed method from the prior art. If the prior art method is capable of performing the intended use, then it meets the claim.
Applicant is claiming a method in instant claim 8 wherein the skin is treated to increase oxytocin production via the step of application of the recited topical skin composition. Once the method is met by the prior art the intended use of the claim is an innate property of the product or composition recited in the method step. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, because Banowski teaches the identical composition recited in instant claim 1 and the identical manipulative step of the method, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, because the method is taught by the prior art, the intended use of “skin is treated to increase oxytocin production” is met.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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