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 .
Priority
The instant application was filed 18 April 2024 and is the national stage entry of PCT/IL2022/051150 filed 30 October 2022. The Applicant claims priority to provisional application 63/273,947 filed 31 October 2021. The effective filing date of the instant application is 31 October 2021.
Election/Restrictions
Applicant’s election of Group I (claims 1-11 and 17) and acetyl hexapeptide in the reply filed on 30 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claim 1 is 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 describes a composition for treatment of the skin comprising at least two components selected from a superfood, a peptide, a hyaluronic acid or derivative, and an agent selected from a prebiotic and a postbiotic. The Applicant’s specification does not define or specify the derivatives for hyaluronic acid and thus may vary greatly in structure and/or function. The specification also does not provide for a sufficient representative number of species that would allow for all the types of derivatives or analogues that can exist for the listed compounds. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (MPEP 2163 II).
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 1 is 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 1 recites “a hyaluronic acid (HA) or derivative thereof.” The Applicant’s specification does not define or specify the derivatives for hyaluronic acid and thus may vary greatly in structure and/or function. The specification also does not provide for a sufficient representative number of species that would allow for all the types of derivatives that can exist for hyaluronic acid.
MPEP 2163 II - A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). In this case, the genus is “derivatives” of hyaluronic acid.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Avram (US 2024/0299338 A1).
Regarding claim 1, Avram teaches a composition comprising glycerin (superfood), hyaluronic acid, and a prebiotic (Tables 3 and 4). The composition for treatment of the skin is interpreted as intended use and is given minimal patentable weight. See MPEP 2111.02(II).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4, 7, 8, 10, 11, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeson et al. (US 2020/0060957 A1).
Regarding claim 1, Leeson teaches a skin composition formulated as a cream (abs; entire teaching). The composition may comprise a peptide (para. 17), hyaluronic acid (para. 56), and a prebiotic (para. 16).
Regarding claim 2, the composition may comprise both a prebiotic and postbiotic (para. 16).
Regarding claim 3, glycerin (para. 54), citric acid (para. 17), peptides (para. 17), and hyaluronic acid (para. 56) may be active ingredients in the formulation (para. 55) in an amount of 0.005-99% (para. 14).
Regarding claim 4, the composition may comprise glycerin (para. 54) and citric acid (para. 17).
Regarding claim 7, the composition may also include a probiotic (para. 16).
Regarding claim 8, the composition may include Lactobacillus probiotics (para. 54).
Regarding claim 10, the amount of hyaluronic acid as an acid (para. 56) or active ingredient (para. 55) may be 0.005-99% (para. 14).
Regarding claim 11, the composition may comprise a UV agent, which is interpreted as a SPF agent (para. 53).
Regarding claim 17, the composition may be in the form of a cream (abs).
Leeson does not teach an exact combination of hyaluronic acid, peptide, and a prebiotic in claim 1.
In regards to selecting the combination of hyaluronic acid, peptide, and a prebiotic in claim 1, “[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.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 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 at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Leeson teaches a skin composition formulated as a cream comprising a peptide (para. 17), hyaluronic acid (para. 56), and a prebiotic (para. 16), whereas the claimed invention is directed towards a composition comprising at least two components selected from a superfood, a peptide, a hyaluronic acid, and an agent selected from a prebiotic and a postbiotic. Since Leeson teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeson et al. (US 2020/0060957 A1), as applied to claim(s) 1-4, 7, 8, 10, 11, 17 above, in view of Tiege (tiege.com).
In regards to claim(s) 1-4, 7, 8, 10, 11, 17, Leeson et al., as applied supra, is herein applied in its entirety for its teachings of a skin composition formulated as a cream comprising a peptide (para. 17), hyaluronic acid (para. 56), and a prebiotic (para. 16).
Leeson does not teach acetyl hexapeptide in claim 5.
Regarding claim 5, Tiege teaches that acetyl hexapeptide is used in skincare for antiaging and wrinkle-reducing properties (pg. 1).
Since Leeson does not teach acetyl hexapeptide in claim 5, one of ordinary skill in the art would have been motivated to use Tiege’s teaching of acetyl hexapeptide in skincare with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings to improve Leeson’s anti-aging and anti-wrinkle skin composition (para. 16) comprising peptides (para. 17). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeson et al. (US 2020/0060957 A1), as applied to claim(s) 1-5, 7, 8, 10, 11, 17 above, in view of Tiege (tiege.com), and further in view of Ultrus Prospector (ulprospector.com).
In regards to claim(s) 1-5, 7, 8, 10, 11, 17, Leeson et al., as applied supra, is herein applied in its entirety for its teachings of a skin composition formulated as a cream comprising a peptide (para. 17), hyaluronic acid (para. 56), and a prebiotic (para. 16).
Regarding claim 6, Leeson teaches palmitoyl tetrapeptide-7 as a cosmetic active ingredient (para. 54) in an amount of 0.005-99% (para. 14).
Leeson does not teach palmitoyl tripeptide-1 in claim 6.
Regarding claim 6, Ultrus Prospector teaches that palmitoyl tripeptide-1 is used in anti-aging products and wrinkle treatment skin products (pg. 1).
Since Leeson does not teach palmitoyl tripeptide-1 in claim 6, one of ordinary skill in the art would have been motivated to use Ultrus Prospector’s teaching of palmitoyl tripeptide-1 in skincare in an amount of 0.005-99% with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings to improve Leeson’s anti-aging and anti-wrinkle skin composition (para. 16) comprising peptides (para. 17). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeson et al. (US 2020/0060957 A1), as applied to claim(s) 1-8, 10, 11, 17 above, in view of Tiege (tiege.com) and Ultrus Prospector (ulprospector.com), and further in view of Kawada et al. (Ingestion of hyaluronans (molecular weights 800 k and 300 k) improves dry skin conditions: a randomized, double blind, controlled study, J. Clin. Biochem. Nutr., 2014).
In regards to claim(s) 1-8, 10, 11, 17, Leeson et al., as applied supra, is herein applied in its entirety for its teachings of a skin composition formulated as a cream comprising a peptide (para. 17), hyaluronic acid (para. 56), and a prebiotic (para. 16).
Leeson does not teach a molecular weight for hyaluronic acid in claim 9.
Regarding claim 9, Kawada teaches that hyaluronic acid is used in cosmetics to improve skin conditions, where the molecular weight of 50k to 200k for hyaluronic acid is found to moisturize the skin (pg. 66).
Since Leeson does not teach a molecular weight for hyaluronic acid in claim 9, one of ordinary skill in the art would have been motivated to use Kawada’s teaching of 50k to 200k for hyaluronic acid with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings to improve Leeson’s anti-aging, anti-wrinkle skin (para. 16), and moisturizing (claim 5) composition comprising hyaluronic acid (para. 56). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
