DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant's election with traverse of Group I (claims 34-44) and the species of organic UV protecting chemical and glutathione in the reply filed on 12 August 2026 is acknowledged. The traversal is on the ground(s) that the cited art does not anticipate the shared technical feature. This is not found persuasive because anticipation is not required, as the reference cited suggests the combination of the elements of the shared technical feature. The requirement is still deemed proper and is therefore made FINAL.
Claim 37 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of promoter agents, there being no allowable generic or linking claim. Claims 45-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 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 34-36 and 38-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Independent claim 34 (and the dependent claims 39-41 and 43) are directed to a topical composition comprising ergosterol and a UV-protecting component such as zinc oxide. Dependent claims 35-36, 38, and 42 recite the further inclusion of an agent such as glutathione. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only components listed are the naturally occurring ingredients. There is nothing in the specification to indicate that, when combined, there is any additional functionality beyond that which each substance has individually.
The analysis set forth for evaluating subject matter eligibility under section 101 is discussed in MPEP 2106. Step 1 is to determine if the claim is to a process, machine, manufacture, or a composition of matter. For the instantly recited invention, this is true. The claims are directed to composition of matter. Thus, the analysis continues to step 2A.
Step 2A consists of two prongs. The first prong of step 2A is if the claim recites an abstract idea, a law of nature, or a natural phenomenon. The claims are directed to a natural phenomenon (i.e. products of nature as all elements are naturally occurring). Thus, the claims are drawn to products of nature, and the analysis continues to the second prong of step 2A.
The second prong of step 2A is does the claim recite additional elements that integrate the judicial exception into a practical application. The claims are directed to the topical composition, and there are no elements recited as limitations which integrate the mixture into a practical application. Thus, as there is nothing else in the claim other than the judicial exception, the analysis continues to step 2B.
Step 2B is does the claim recite additional elements that amount to significantly more than the judicial exception. And the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only components listed are the naturally occurring ingredients. The only additional limitations are uses for the composition, but the claims are not directed to the method. There is no limitation to the claimed invention requiring anything which is not drawn to a judicial exception. And there is nothing in the specification to indicate that for the mixture of these ingredients there is any additional functionality beyond that which each substance has individually. Thus, the claims are considered to not be drawn to eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claim 35 is 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 35, the phrase "such as" 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).
Claim 36 is 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.
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 36 recites the broad recitation lipoic acid, and the claim also recites that it is oxidized which is 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 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.
(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.
Claims 34, 39-41, and 43-44 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Robinson (US Patent 6,224,854).
Robinson discloses UV protection compositions that comprise dibenzyl methane sunscreen actives (which are organic sunscreen actives) (abstract). Robinson also suggests the option of including ergosterol in the composition (column 10, lines18-28). This disclosed composition anticipates the composition recited by instant claim 34.
Instant claims 39-41 and 43-44 recite limitations to the use of the composition (such as it being used to treat a disease associated with reduced levels of Vitamin D). Robinson does not teach these limitations. However, the claims are drawn to a composition, and the body of the claim recites a structurally complete invention. Furthermore, the intended use does not appear to result in a structural difference between the claimed invention and the prior art (the composition taught Robinson is applicable to skin and has the same active ingredients are required by the instant claims and thus appears to be useful for this purpose). See MPEP 2111.02(II).
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.
Claims 34-36 and 38-44 are rejected under 35 U.S.C. 103 as being unpatentable over Baptiste et al. (US Patent Application Publication 2020/0121575).
Baptiste et al. discloses cosmetic blends for use on skin (paragraph [1]). The blend can comprise actives for modulating skin pigmentation, such as the sterol ergosterol and/or the sulfur-containing molecule glutathione (paragraph [220]). The blend can also comprise sun protection factors, which include organic-molecule sun protection factors (paragraphs [118-119]).
Thus, Baptiste et al. discloses compositions comprising the individual elements the instantly recited composition and together these would provide a composition as instantly claimed. However, Baptiste et al. is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions, a prima facie case of obviousness exists. See MPEP 2141.
Instant claim 38 further limits the amount of the ergosterol, and the amount of the actives for modulating skin pigmentation taught by Baptiste et al. is from 0.001 to 5 wt% (paragraph [223]).
Instant claims 39-44 recite limitations to the use of the composition (such as it being used to treat a disease associated with reduced levels of Vitamin D). Baptiste et al. does not teach these limitations. However, the claims are drawn to a composition, and the body of the claim recites a structurally complete invention. Furthermore, the intended use does not appear to result in a structural difference between the claimed invention and the prior art (the composition taught by Baptiste et al. is applicable to skin and has the same active ingredients are required by the instant claims and thus appears to be useful for this purpose). See MPEP 2111.02(II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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