Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Applicants filed claims 1 – 102 with the instant application on 3 May 2024. In a Preliminary Amendment filed 19 August 2024, Applicants amended claims 44, 49, 51, 52, 55 – 57, 58, 64,67, 71, 73, 77, 82, 84, 85, 87, 89, 90, 92, 94, 98, and 100, and canceled claims 1 – 41, 45, 46, 56, 59 – 63, 65, 66, 68 – 70, 75, 76, 78 – 81, 83,86, 88, 95, 97, 99, 100, and 102. Upon finalization and entry of the Restriction/Election Requirement (see below), claims 42 – 44, 47 – 49, 51 - 55, 57, 58, 64, 67, 71, 73, 74, 77, 82, 84, and 85 will be available for substantive examination.
Response to Restriction/Election Requirement
Applicant's election with traverse of the invention of Group I, claims 42 – 44, 47 – 49, 51 - 55, 57, 58, 64, 67, 71, 73, 74, 77, 82, 84, and 85, in the Response filed on 12 June 2026 is acknowledged. The traversal is on the grounds that “the Examiner has not established that both (A) [combination does not require the particulars of the sub-combination for patentability] and (B) [the sub-combination can be shown to have utility either by itself or in another materially different combination] are satisfied, which is required by MPEP § 806.05(c). Applicants base their argument on the allegation that “the Group II claims depend from, and therefore require, the particulars of claim 42 in Group I,” so that part (A) is not satisfied. However, the Examiner notes that the Restriction Requirement of 15 April 2026 had inadvertently reversed the characterizations of Groups I and II. In fact, Group 1 (broad) is the combination invention, and Group II (narrow) is the sub-combination (see MPEP § 806.05(c) II A.). Thus, Group I (combination) does not require the particulars of the sub-combination of Group II (capsule dosage forms) as claimed for patentability, and the sub-combination can be shown to have utility either by itself, or in another materially different combination.
The Examiner also acknowledges Applicants election of the following species from the genera identified in the Action of 15 April 2026: reduced fine lines and/or wrinkles, from the genus of skin property; facial region from the genus of body site; crow's feet wrinkles from the genus of dermatological sign of aging; and eye from the genus of facial region.
Accordingly, claims 42 – 44, 47 – 49, 51 - 55, 57, 58, 64, 67, 71, 73, 74, 77, 82, 84, and 85 are subject to examination on the merits, to the extent that reduced fine lines and/or wrinkles, are the skin property; facial region is the body site; crow's feet wrinkles are the dermatological sign of aging; and eye is the facial region.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 42 – 44, 47 – 49, 51 - 55, 57, 58, 64, 67, 71, 73, 74, 77, 82, 84, and 85 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Boisnic, S., et al., Journal of Cosmetic Dermatology 2019: 1 – 10, identified in the Information Disclosure Statement (IDS) filed 29 January 2025, cite no. 31 (NPL) (“Boisnic (2019)”), in view of Hsu, T.-F., et al., Nutrients 13: 2220 (2021) (“Hsu (2021)”), and Oe, M., et al., Clinical, Cosmetic and lnvestigational Dermatology 10: 267 – 273 (2017), identified on the IDS filed 29 January 2025, cite no. 72 (NPL) (“Oe (2017)).
The Invention As Claimed
Applicants claim methods for improving a skin property, improving a dermatological sign of aging, and improving skin smoothness, wherein each method comprises the step of orally administering to a human subject a skincare supplement that comprises a dose of hyaluronic acid and a dose of a lipid extract comprising a ceramide and a glycolipid, the administration being once per day for at least eight weeks, wherein the skin property, and the dermatological sign of aging, is fine lines and/or wrinkles, such as crow’s feet wrinkles, wherein the skin property, and the dermatological sign of aging, is improved by about day 56, wherein the dermatological sign of aging occurs in a facial region, wherein skin smoothness is improved and maintained by at least about day 63, wherein the facial region is the eye, wherein the human subject is an adult of about 18 years old to about 65 years old, wherein the supplement is essentially free of a component derived from an animal, wherein the HA has an average molecular weight of about 2 kDa to about 800 kDa, wherein the dose of HA is about 25 mg to about 240 mg, wherein the dose of lipid extract is about 70 mg to about 400 mg, wherein the weight per cent, in the lipid extract, of the ceramide is about 2%, and the weight per cent of the phospholipid is about 15%, wherein the dose of lipid extract is about 70 mg to about 400 mg, and wherein the lipid extract is obtained from wheat.
The Teachings of the Cited Art
Boisnic (2018) discloses that polar lipids from wheat (Triticum vulgare) extract oil (WEO) are known to improve skin hydration (see Abstract), wherein the antiaging effects and benefits for the skin from administration of these polar lipids was investigated in a double-blind, randomized, placebo-controlled clinical study on 64 healthy women, aged from 45 to 60 years, the study lasting for 20 weeks, including 12 weeks of administration of oral supplementation with WEO or placebo, and 8 weeks of follow-up, wherein wrinkles in the crow’s-feet area, skin hydration, skin roughness, and radiance of participants were evaluated by clinical scoring (see Methods), wherein a lipid extract prepared from the endosperm of wheat grain (Triticum vulgare) in the form of a wheat extract oil, the extract being rich in polar lipids and used for its skin moisturizing benefits, wherein a study reported that the highly complex lipid composition WEO primarily comprises phospholipids (PL’s), glycolipids (GL’s), and sphingolipids (SL’s) (see p. 2, 1st col., 2nd para.), wherein ceramides from the sphingolipid family represent 35%-40% of the lipid cement ensuring cell cohesion in the stratum corneum, and are highly involved in skin hydration by limiting excessive water loss from the epidermis (see p. 2, 1st col., 3rd para.), wherein WEO has significant clinical effects on the skin, demonstrating clinically a significant increase in skin hydration with clinical improvements in flakiness, roughness, and redness after 3 months of WEO supplementation (see p. 2, 1st col., 4th para.), wherein, in investigating the potential anti-aging effects of WEO, the primary outcome of the clinical trial was the efficacy of WEO on wrinkle reduction, and the secondary end points were the confirmation of the hydrating properties, its positive effect on skin condition and appearance, and the duration of these effects following the
end of oral supplementation (see p. 2, 2nd col., 1st para.), wherein the WEO capsules administered to study participants contained 70 mg of glycolipids [20%], such as digalactodiacylglycerol (DGDG), 9.5 mg [2.7%] of sphingolipids, such as ceramides and glycoceramides, 35 mg [10%] of phospholipids, and 235.5 mg of triglycerides and other lipids (350 mg total) (see p. 2, 2nd col., 7th para.), wherein the wrinkle evaluation score decreased in the WEO group by 1.00 ± 0.7 points after 12 weeks of supplementation compared to the placebo group, which score decreased by 0.34 ± 0.5 points (see Figure 1A), and the change from baseline being significant between the two groups, particularly in the WEO group after 8 weeks of supplementation (P < 0.0002), the effect continuing for 8 weeks after the end of supplementation, with a visible improvement of the crow's-feet wrinkles seen from 8 weeks and maintained at 12 weeks (see p. 4, 1st col., 5th para.; see also, Figure 1C), wherein corneometry measurements showed a significant improvement in facial skin hydration in the WEO group after 12 weeks of supplementation, compared with the placebo group (+5.18 ± 2.19; P 0.0211) (see p. 4, 1st col., 6th para.; see also, Figure 2B), and wherein the improvements in skin hydration and wrinkle reduction are concomitant with the improvement of skin qualities such as skin roughness and radiance along with global satisfaction
by the subjects (see p. 7, 1st col., last para. – 2nd col., 1st para.). The reference does not disclose a skincare supplement comprising hyaluronic acid, with molecular weights between about 2 kDa and about 300 kDa, in addition to the wheat extract oil (WEO). The teachings of Hsu (2021) and Oe (2017) remedy those deficiencies.
Hsu (2021) discloses the results of a placebo-controlled, randomized, double-blind trial of daily hyaluronic acid (HA) (120 mg) intake for 12 weeks in 40 healthy Asian men and women (aged 3~ years), where skin condition was determined by an evaluation of wrinkles, stratum corneum water content, the amount of transepidermal water loss, and elasticity, and through image analysis, wherein, after 12 weeks, skin condition was significantly improved in terms of wrinkle assessment, stratum corneum water content, transepidermal water loss, and elasticity in the HA group compared to the placebo group (see Abstract), wherein study subjects received 120 mg/ capsule/day of HA or the placebo, taken orally, for 12 consecutive weeks (see p. 2, 3rd para.), wherein an assessment of skin hydration showed that the HA group had significantly higher stratum corneum water content in the facial measurement sites (p = 0.02) as compared with the placebo group, at 12 weeks after ingestion, while, with respect to change from baseline after treatment, the HA group showed a significantly higher percentage change in stratum corneum water content compared with the placebo group at 8 weeks (p = 0.01) and 0.01) and 12 weeks (p = 0.0003) for the face (see p. 4, 1st para.), wherein the results of the study revealed that oral ingestion of HA for 12 weeks significantly improved multiple parameters (e.g., skin moisturization and wrinkles) compared to the placebo, with no adverse events attributable to the consumption of HA (see p. 8, 1st para.), and wherein oral ingestion of HA for 12 weeks can improve wrinkle control and skin condition demonstrating that the consumption of HA can be used as a functional food that contributes to the maintenance of skin health (see p. 9, 4th para.).
Oe (2017) discloses the results of a study involving sixty male and female subjects aged 22 - 59 years who presented with crow's feet wrinkles, and were randomly assigned to the HA 2 kDa or HA 300 kDa groups receiving 120 mg HA/day, or to the placebo group for 12 weeks, with skin wrinkles being evaluated by image analysis of skin wrinkle replicas (see Abstract), wherein the effect on skin wrinkles through the use of oral HA is expected because a decrease in skin damage leads to relieving of skin wrinkles (see p. 267, 3rd para.), wherein the placebo group received two capsules containing 210 mg microcrystalline per capsule, and the HA 2 kDa group received two capsules comprising 60 mg HA and 150 mg of microcrystalline cellulose each day, while the HA 300 kDa group received two capsules comprising 60 mg HA and 150 mg microcrystalline cellulose each day (see p. 268, 2nd col., 2nd para.), wherein, in a wrinkle volume ratio measure after 8 weeks ingestion, the HA 300 k group showed significantly lower values than the placebo group (p = 0.05) (see p. 270, 2nd col., 1st para.), and wherein study results showed that oral ingestion of 2 kDa and 300 kDa HA for 12 weeks suppresses wrinkle and improves the skin’s luster and suppleness in people aged 59 or less (see p. 272, 2nd col., 2nd para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to treat various skin conditions with a skin care supplement that comprise polar lipids from wheat (Triticum vulgare) extract oil (WEO), wherein the antiaging effects and benefits for the skin from administration of these polar lipids was investigated in a double-blind, randomized, placebo-controlled clinical study on 64 healthy women, aged from 45 to 60 years, the study lasting for 20 weeks, including 12 weeks of administration of oral supplementation with WEO or placebo, and 8 weeks of follow-up, wherein wrinkles in the crow’s-feet area, skin hydration, skin roughness, and radiance of participants were evaluated by clinical scoring, wherein a lipid extract was prepared from the endosperm of wheat grain (Triticum vulgare) in the form of a wheat extract oil, the extract being rich in polar lipids and used for its skin moisturizing benefits, wherein WEO has significant clinical effects on the skin, demonstrating clinically a significant increase in skin hydration with clinical improvements in flakiness, roughness, and redness after 3 months of WEO supplementation, wherein, in investigating the potential anti-aging effects of WEO, the primary outcome of the clinical trial was the efficacy of WEO on wrinkle reduction, and the secondary end points were the confirmation of the hydrating properties, its positive effect on skin condition and appearance, and the duration of these effects following the end of oral supplementation, wherein the WEO capsules administered to study participants contained 70 mg of glycolipids [20%], such as digalactodiacylglycerol (DGDG), 9.5 mg [2.7%] of sphingolipids, such as ceramides and glycoceramides, 35 mg [10%] of phospholipids, and 235.5 mg of triglycerides and other lipids (350 mg total) (see p. 2, 2nd col., 7th para.), wherein the wrinkle evaluation score decreased in the WEO group by 1.00 ± 0.7 points after 12 weeks of supplementation compared to the placebo group, which score decreased by 0.34 ± 0.5 points (see Figure 1A), and the change from baseline being significant between the two groups, particularly in the WEO group after 8 weeks of supplementation (P < 0.0002), the effect continuing for 8 weeks after the end of supplementation, with a visible improvement of the crow's-feet wrinkles seen from 8 weeks and maintained at 12 weeks, wherein corneometry measurements showed a significant improvement in facial skin hydration in the WEO group after 12 weeks of supplementation, compared with the placebo group (+5.18 ± 2.19; P 0.0211), wherein the improvements in skin hydration and wrinkle reduction are concomitant with the improvement of skin qualities such as skin roughness and radiance along with global satisfaction by the subjects, as taught by Boisnic (2018), wherein the skin care supplement also comprises hyaluronic acid (HA) orally administered daily at 120 mg for 12 weeks in 40 healthy men and women, wherein, after 12 weeks, skin condition was significantly improved in terms of wrinkle assessment, stratum corneum water content, transepidermal water loss, and elasticity in the HA group compared to the placebo group, wherein an assessment of skin hydration showed that the HA group had significantly higher stratum corneum water content in the facial measurement sites (p = 0.02) as compared with the placebo group, at 12 weeks after ingestion, while, with respect to change from baseline after treatment, the HA group showed a significantly higher percentage change in stratum corneum water content compared with the placebo group at 8 weeks (p = 0.01) and 0.01) and 12 weeks (p = 0.0003) for the face (see p. 4, 1st para.), wherein the results of the study revealed that oral ingestion of HA for 12 weeks significantly improved multiple parameters (e.g., skin moisturization and wrinkles) compared to the placebo, with no adverse events attributable to the consumption of HA, and wherein oral ingestion of HA for 12 weeks can improve wrinkle control and skin condition demonstrating that the consumption of HA can be used as a functional food that contributes to the maintenance of skin health, as taught by Hsu (2021), and wherein study results showed that oral ingestion of 2 kDa and 300 kDa HA for 12 weeks suppresses wrinkle and improves the skin’s luster and suppleness in people aged 59 or less (see p. 272, 2nd col., 2nd para.), as taught by Oe (2017). One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Hsu (2021) to the effect that, after 12 weeks of administration of 120 mg HA/day, skin condition was significantly improved in terms of wrinkle assessment, stratum corneum water content, transepidermal water loss, and elasticity in the HA group compared to the placebo group, and wherein an assessment of skin hydration showed that the HA group had significantly higher stratum corneum water content in the facial measurement sites (p = 0.02) as compared with the placebo group, at 12 weeks after ingestion, while, with respect to change from baseline after treatment, the HA group showed a significantly higher percentage change in stratum corneum water content compared with the placebo group at 8 weeks (p = 0.01) and 0.01) and 12 weeks (p = 0.0003) for the face (see p. 4, 1st para.), and by the teachings of )e (2017) to the effect that oral ingestion of 2 kDa and 300 kDa HA for 12 weeks suppresses wrinkles and improves the skin’s luster and suppleness in people aged 59 or less (see p. 272, 2nd col., 2nd para.).
The Examiner notes that the methods of the claimed invention are directed to improvements in various measures of skin condition as the result of oral administration of a skin care supplement comprising HA and a lipid extract. It is the Examiner’s position that the skin conditions addressed by administration of the supplements of the invention are all based on the same underlying physiological phenomena, such as moisture content in the stratum corneum, as addressed in the cited art. Consequently, one of ordinary skill in the relevant art would recognize that administration of the supplement of the invention to address any one of the skin conditions recited in the claims would necessarily the other skin care conditions.
With respect to claim 71, which claim recites a limitation directed to the supplement being essentially free of components derived from an animal, the Examiner notes that the cited references do not directly address the question of animal sources for components of the supplements. However, the lipid extract disclosed in Hsu (2021) is prepared from the endosperm of wheat grain (Triticum vulgare) in the form of a wheat extract oil and, further, that the HA used by both Hsu (20217) and Oe (2017) were obtained from the same commercial source, Kewpie Corporation, Tokyo, Japan, and obtained from vegetarian sources. Thus, all components of the supplements disclosed in the cited art are presumed to not have been obtained from animal sources.
With respect to those claims reciting limitations directed to quantitative measures of the content of various components in the supplements, the Examiner notes that the relative content disclosed in the cited references are not exactly congruent with the claim limitations. However, it is the Examiner’s position that the cited art teaches a range of loadings of these components that significantly overlap with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘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).”
Further with respect to claim 82, which claim recites a limitation directed to the relative mass amounts of glycolipid and ceramide in the lipid extract, the Examiner notes that the cited references do not specifically address such relative loadings. However, Hsu (2021) discloses that the lipid extracts from wheat germ (WEO) have complex highly complex lipid compositions primarily comprising phospholipids (PL’s), glycolipids (GL’s), and sphingolipids (SL’s) (see p. 2, 1st col., 2nd para.). Thus, the cited art does not characterize such complex extracts in terms only of DGDG and ceramides. However, the reference does disclose a more specific breakdown of relative mass contents in supplement capsules of the various lipids in the extracts (70 mg of glycolipids [20%], such as digalactodiacylglycerol (DGDG), 9.5 mg [2.7%] of sphingolipids, such as ceramides and glycoceramides, 35 mg [10%] of phospholipids, and 235.5 mg of triglycerides and other lipids (350 mg total) (see p. 2, 2nd col., 7th para.)). Consequently, it is the Examiner’s position that the disclosures read on, or overlap with, the claim limitation. However, the Examiner would further note that one of ordinary skill in the relevant art would appreciate that the identities and contents of various fractions obtained by extraction from natural sources, such as wheat germ, can be rather complex, the exact makeup of which would be a function not only of the natural source for the extracts, but also of the conditions of extraction. Consequently, it is the Examiner’s position that obtaining wheat germ extracts that comprise amounts of ceramide and glycolipids that read on the claimed amounts would amount to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameters, these limitation cannot support patentability. See MPEP § 2144.05 II. A.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 42 – 44, 47 – 49, 51 - 55, 57, 58, 64, 67, 71, 73, 74, 77, 82, 84, and 85 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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