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 .
Status of the Claims
Claims 1-12 and 14 are pending. Claim 14 is withdrawn. Claims 1-12 are rejected.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 3/20/2024 and 5/31/2024 were considered by the Examiner.
Election/Restrictions
Applicant’s election of Group I (claims 1-12) in the reply filed on 7/20/2026 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Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Interpretation
Regarding instant claims 10-12, the claims do not require an active step of assessing, only that skin signs/parameters will be assessed using image and blood analysis. Therefore, the prior art is not required to teach active steps of assessing, neither by image, nor blood.
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.
Claims 3, 4, 6, 9, 10, 11 and 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.
Regarding claims 3, 4, 6, and 9-12, the phrase "e.g." (multiple locations) (and “for example”-claims 11 and 12) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 3 recites the broad recitations “dosage of resveratrol is 50 mg to 1000 mg per day”, and the claim also recites “especially” (line 3) with smaller amounts directly following,
claim 4 recites the broad recitations “topical formulation of resveratrol is administered to the skin in an amount of about 2 mg/cm2”, and the claim also recites “especially” (line 4) with smaller amounts directly following,
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 § 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) 1, 2, 4, 6, 7, 8, 9, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US20200046617).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Thomas et al. discloses a method of treating aging skin comprising administering to a person in need thereof a composition including resveratrol or a derivative thereof (see claim 17). The composition may be delivered orally and topically (see claims 18 and 19). The composition is administered to treat one or more of loss of skin firmness, thinning of the skin, wrinkles, fine lines, dull complexion and pigmentary spots (see claim 20). The resveratrol may be “trans”-resveratrol [also known as “3,5,4’-trihydroxy-trans-stilbene”] (see para. [0033]). (Thomas also discloses the inclusion of betaine, wherein the instant claims transitional phrase of “comprising” allows for the addition of other components.) The prior art also allows for the combination of both oral and topical treatments simultaneously, separately, or sequenced over time (see para. [0142]). Thomas defines elderly as “in particular over 40 years old” (see para. [0054]), with the resveratrol composition increasing mitochondrial activity under conditions mimicking that of cells of an elderly subject (see para. [0098]).
Thomas teaches the following in para. [0132]: “According to one aspect of the invention, resveratrol, or derivatives thereof, increase the production of collagen and/or elastin by the cutaneous cells, in particular by fibroblasts of human skin.” Example 1 of Thomas on p. 7 demonstrates the action of trans-resveratrol on ATP production (in vitro). “The association of resveratrol and betaine significantly increases the intracellular ATP production, which is 68% greater than that of untreated cells” (see para. [0176]).
Regarding application intervals and treatment lengths, Thomas teaches the following:
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67
298
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. Additionally regarding percentages, Thomas teaches the following:
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96
299
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach a single embodiment of 3,5,4’-trihydroxy-trans-stilbene administered both orally and topically (in vivo).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1, 2, 7, and 10-12, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to administer trans-resveratrol both orally and/or topically to a human over the age of 40, in view of the teachings of Thomas. One of ordinary skill in the art would have been motivated to do so, with a reasonable expectation of success, because:
Thomas’s resveratrol composition increased mitochondrial activity under conditions mimicking that of cells of an elderly subject (see para. [0098]).
Thomas’s resveratrol, or derivatives thereof, increase the production of collagen and/or elastin by the cutaneous cells, in particular by fibroblasts of human skin (see para. [0132]).
Example 1 of Thomas on p. 7 demonstrates the action of trans-resveratrol on ATP production (in vitro). “The association of resveratrol and betaine significantly increases the intracellular ATP production, which is 68% greater than that of untreated cells” (see para. [0176]).
Regarding instant claim 4, which is rejected supra for being indefinite, the prior art percentages embrace the instant claims. Regarding instant claim 6 and the limitation of treatment for “at least four weeks”, the prior art teaches the treatment may endure several weeks. A skilled artisan would have been motivated to arrive at “at least four weeks” as a result of routine experimentation, with a reasonable expectation in treatment success. “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)”. See MPEP 2144.05(IIA). Additional limitations following an “e.g.” are not required because of the indefiniteness described supra.
Regarding instant claims 8 and 9, it would have been obvious to a skilled artisan trying to improve skin health (including wrinkle treatment) that signs of skin aging would have been reduced as a result of administering resveratrol, as this is an indicator of treatment efficacy. Therefore, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”. Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. See MPEP 2145(II).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US20200046617), as applied to claims 1, 2, 4, 6, 7, 8, 9, and 10-12 above, and further in view of Howe et al. (US20160213584).
**The 103 rejection of claims 1, 2, 4, 6, 7, 8, 9, and 10-12 over Thomas et al. (US20200046617), supra, is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Howe’s invention provides compositions comprising resveratrol with increased bioactivity, bioavailability and/or efficacy and methods of using such compositions in health maintenance and the treatment of conditions and disorders (see para. [0002]).
Regarding amounts of resveratrol, Howe specifically teaches a method for treating a skin condition comprising administering a composition comprising resveratrol, wherein the composition comprises 50% resveratrol (see claims 37 and 45). In one embodiment, “a composition comprising resveratrol, lecithin, and grape seed oil is administered orally to a subject at a dosage of between 50-500 mg, or topically at a dosage of between about 25-50 mg” (see para. [0029]). ***[The whole oral composition of Howe is 50-500 mg, with the teaching that compositions may comprise 50% resveratrol rendering the amount of resveratrol from 25-250 mg.]
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment in the prior art of the mg amounts of an oral dose of resveratrol, with the simultaneous administration of topical resveratrol.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 3 and 5, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the amount of oral resveratrol taught by Thomas in the composition, in view of Howe. One of ordinary skill in the art would have been motivated to do so, with a reasonable expectation of success, because:
*** The whole oral composition of Howe may be 50-500 mg, with Howe also teaching that compositions may comprise 50% resveratrol, rendering the amount of resveratrol from 25-250 mg.
Both Howe and Thomas teach the use of resveratrol in skin treatment.
The prior art oral resveratrol amount overlaps with the instant range of 50 mg to 1000 mg per day, particularly 150 mg per day. Specifically regarding instant claim 5, the topical percentage dose was embraced by Thomas, supra, and taught the inclusion of trans-resveratrol [also known as “3,5,4’-trihydroxy-trans-stilbene”]. The limitations of orally “administered in a divided dose of 75 mg in the morning and 75 mg in the evening” and topically “administered to the face of the subject in a dosage of about 1 g in the morning and about 1 g in the evening” would have been obvious to a skilled artisan as a result of routine optimization. “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)”. See MPEP 2144.05(IIA).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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