DETAILED ACTION
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 Application
Receipt is acknowledged of Applicants’ remarks, filed on 12/23/25. No claims have been amended.
Claims 1-4, 6, 8, 10, 13, 48-49, 51-55, and 58 are pending and are examined on the merits herein.
Priority
The instant application claims domestic benefit to 63/232,561 filed on 08/12/2021.
The following are maintained grounds of rejection.
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.
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.
Claims 1-2, 6, 8, 10, 13, 48-49, 51-55, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Ou (US20200113803A1; IDS 02/09/2023) in view of Marini et al. (US 10,610,479 B2; IDS 02/09/2023).
Ou teaches anhydrous compositions comprising small molecule polysaccharides that are capable of direct penetration across the horny layer of the skin as well as a method of effectively maintaining skin hydration level in a subject in need thereof, comprising topically administering to the subject an anhydrous composition of small-molecule polysaccharides (abstract). Ou discloses an anhydrous hyaluronic acid containing composition wherein the small-molecule hyaluronic acid has a molecular weight ranging from 4 kDa to 8 kDa. (claim 2, [0010], and Table 4). Ou further discloses compositions of an anhydrous hyaluronic acid containing composition wherein the hyaluronic acid is at a concentration from 0.5% w/v to 3% w/v, based on a total volume of the anhydrous composition (claim 4). Ou states that hyaluronic acid can refer to hyaluronic or a salt thereof [0032]. Ou discloses that the composition was capable of increasing skin elasticity and the increased skin elasticity was effectively maintained for at least 14 days ([0058] and Figure 5). Ou further demonstrates that the presence or absence of water in the sample and the molecular weight of HA both affected the skin hydration level of the applied skin area. In particular, the anhydrous formulation of HA compositions exhibits better ability to retain water for a longer period of time [0049]. The retention of water leads to an improvement in wrinkle formation, skin laxity, or sunken skin [0063].
Ou does not teach that the composition comprise a retinoid (instant claim 1), or wherein the composition is a cream, gel, lotion, emulsion, or serum (instant claim 49).
Marini teaches that skin volume, resilience, and pliability are decreased with age at least in part due to altered patterns and levels of glycosaminoglycans (GAGs), especially hyaluronic acid (HA) and that HA forms large complexes that crosslink to other matrix proteins, such as collagen, resulting in the formation of supramolecular structures and functions to provide structure to the skin (col. 1, lines 11-17). Marini teaches cosmetic formulations comprising HA for improving the appearance of the skin (abstract). Marini further teaches that it is advantageous to administer retinol with HA containing compositions because hyaluronic acid and retinol work together to improve the appearance of visible signs of aging to the lips (col. 2, lines 58-60). Retinol brightens the skin and reduces the appearance of fine lines and wrinkles (col. 2, lines 18-20). Marini discloses an HA containing composition further comprising 0.05% to 0.5% retinol, (claim 2), in particular about 0.1% (col. 5, line 15). Marini teaches that the HA containing composition may be formulated as a cream (claim 12 and col. 1, line 59).
One of ordinary skill in the art would have been motivated to incorporate the retinol of Marini in the anhydrous HA composition of Ou because Marini teaches that retinol brightens the skin and reduces the appearance of fine lines and wrinkles and that it is advantageous to administer retinol with HA containing compositions because hyaluronic acid and retinol work together to improve the appearance of visible signs of aging to the lips. One of ordinary skill in the art would have had a reasonable expectation of success because Ou teaches compositions for improving skin appearance and Marini teaches cosmetic formulations comprising HA and retinol for improving the appearance of the skin and states that hyaluronic acid and retinol work together to improve the appearance of visible signs of aging to the lips, thus indicating that retinol is suitable for administration with hyaluronic acid.
Regarding claims 13, 52, and 55, Ou does not disclose the composition having a hyaluronic acid with a molecular weight of 10-40 kDa or 25-100 kDa. However, Ou teaches that the molecular weight of HA affected the skin hydration level of the applied skin area [0049]. Ou demonstrates the application of 2% anhydrous HA compositions comprising small molecule HA with a molecular weight of 110 kDa-120 kDa or 4 kDa-8 kDa [0048]. Ou demonstrates that both the 110 kDa-120 kDa and the 4 kDa-8 kDa compositions were capable of increasing the hydration level of skin (table 5). It would have been prima facie obvious to optimize the molecular weight of the HA in the anhydrous compositions of Ou and Marini beginning with HA in the range of 110 kDa-4 kDa because Ou teaches that the molecular weight of the small-molecule hyaluronic acid affected the skin hydration level provided by the cosmetic composition. Ou thus teaches that molecular weight is a result effective variable such that one of ordinary skill in the art would be motivated to optimize the HA molecular weight to achieve an optimal hydration level for the specific composition suggested by Ou and Marini.
Regarding instant claim 58, instant claim 58 depends on instant claim 48 and recites additional limitations for collagen, elastin, fibronectin, and hyaluronic acid gene expression. However, instant claim 48 recites the alternatives of (a) increasing one or more of collagen, elastin, fibronectin, and hyaluronic acid gene expression in the skin of a subject along with (b) improving the look, feel and/or appearance of the skin, hydrating the skin; plumping the skin; improving skin elasticity; improving the appearance of fine lines and wrinkles; reducing the depth, length, or width of fine lines and wrinkles; and/or smoothing the skin and along with (c) increasing and/or replenishing the level of or increasing production of hyaluronic acid on the surface of the skin and/or in the skin. Thus although instant claim 58 limits the collagen, elastin, fibronectin, and hyaluronic acid gene expression it does not in fact require that (a) is selected. Rather, instant claim 58 contains all of the limitations of instant claim 48 and so also contains (a), (b), and (c) as alternatives. Thus the limitations of instant claim 58 are met by prior art teaching a method of improving the skin comprising improving skin elasticity.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ou (US20200113803A1; IDS 02/09/2023) in view of Marini et al. (US 10,610,479 B2; IDS 02/09/2023), as applied to claim 1, further in view of Bonnet et al. (US20150283055A1; IDS 10/06/2022) and Kondo et al. (J Tissue Eng Regen Med, 2009; PTO-892).
The combined teachings of Ou and Marini are as above.
The combined teachings of Ou and Marini do not teach wherein the composition comprises konjac glucomannan (instant claim 3).
Bonnet teaches polymers of hyaluronate and glucomannan useful as hydration agents (abstract). The polymers are excellent cosmetic ingredients for preventing and/or treating the appearance of wrinkles in the epidermis [0017]. Bonnet teaches that glucomannan is a compound capable of inducing the accumulation of fibroblasts allowing for tissue regeneration. Glucomannan may be cross-linked with hyaluronic acid [0008]. Furthermore, the natural origins of the hyaluronate and the glucomannan makes them entirely biocompatible for topical application [0021].
Kondo teaches a scaffold comprising konjac glucomannan and hyaluronic acid as a scaffold for cartilage regeneration when cultured with chondrocytes (abstract). The konjac glucomannan and hyaluronic acid scaffold is a hydrogel useful for tissue regeneration and the tissue engineering of artificial cartilage (page 366, paragraph 1). Kondo teaches Amorphophallus konjac as the source of the glucomannan (page 362, paragraph 1), and teaches konjac glucomannan as useful for the formation of hydrogels that also comprise hyaluronic acid (page 362, paragraph 2).
One of ordinary skill in the art would have been motivated to combine konjac glucomannan with the hyaluronic acid in the composition of Ou and Marini because Bonnet teaches that hyaluronic acid compositions further comprising glucomannan have the property of inducing the accumulation of fibroblasts to allow for tissue regeneration, and Kondo teaches konjac glucomannan as a source of glucomannan that is suitable for the formation of hydrogels further comprising hyaluronic acid. One of ordinary skill in the art would have had a reasonable expectation of success because Ou teaches hyaluronic acid containing topically applied compositions useful for maintaining skin hydration level and Bonnet teaches that a crosslinked polymer of hyaluronate and glucomannan is useful as a hydration agent in cosmetics and is biocompatible for topical application.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues that the specification does provide the formulations for the RoC HA Capsules and the RoC Retinal capsules in table B and table D, respectively (Remarks, page 6, paragraph 1) and gives the contents of a commercially available HA aqueous formulation (Remarks, page 7, paragraph 1). Applicant argues that appropriate comparisons of these formulations can thus be made evidencing the unexpected superiority of the claimed formulations in relation to either Ou or Marini (Remarks, page 7, paragraph 1). This is not persuasive.
The instant specification gives Tables B and D [0121] as specific examples of an HA and retinoid composition, respectively. The instant specification does not indicate that RoC® HA Serum Capsules and RoC® Retinol Serum Capsules are defined as having the contents of these tables, and thus the comparison cannot be made between the experimental results of the instant specification and that of the closest prior art because there is no way of knowing that any possible unexpected results are due to the anhydrous nature of the anhydrous serum capsules and not to other differences that may be present in the serum compositions and formulations. Regarding the contents of a commercially available HA aqueous formulation and retinol formulation reported in the Remarks, this data is not included in the specification. In order to be considered as evidence of unexpected results, this data would need to be included in a declaration stating that this is the formulation that was tested experimental results. However, if it were submitted in a declaration, there are a number of differences between the components of the claimed and commercially available formulations such that there is no way of knowing what differences in results are due to the claimed features rather than the other differences in the formulations, and thus the claims would not be commensurate in scope with any unexpected results that were shown. For example, the commercially available retinol and HA aqueous formulations are described as containing different ingredients than the respective RoC capsules. For example, hydroxyethylpiperazine ethane sulfonic acid, rye seed, hydrogenated castor oil, and others are listed as components in the commercially available HA aqueous formulation, but not in the RoC formulation. Additionally, it is not clear that the amounts of the components are equal in the claimed versus commercially available formulations. For example, the commercially available retinol formulation comprises glycine soja oil, but it is not clear that the amount of glycine soja oil is the same as that included in the RoC retinol capsule. Similarly, it is not clear that the dosage of retinol is the some in the two compositions.
The closest prior art is Ou, which discloses compositions of an anhydrous hyaluronic acid containing composition wherein the hyaluronic acid is at a concentration from 0.5% w/v to 3% w/v, based on a total volume of the anhydrous composition. MPEP 716.02(e) states that an affidavit or declaration must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, and if not explained should be noted and evaluated, and if significant, explanation should be required.
The Examiner further notes that MPEP 716.02(b) states that the evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and are of both statistical and practical significance.
Applicant further argues that because the vehicle control group in these experiments was "0.15% Retinal in DMSO," an anhydrous formulation of retinol, the statistically significant results of the blended capsule formulations illustrate a statistically significant result over an anhydrous formulation (Remarks, paragraph bridging page 7-8). This is not persuasive.
The instant specification does not indicate that the vehicle control group referred to in Tables 2.1 and 2.2 is synonymous with the 0.15% retinal in DMSO. Rather, one of ordinary skill in the art would expect that the vehicle control group contains only the vehicle and no active compound.
Applicant further provides a graph of COL3A1 expression profiles (Remarks, page 9) and argues that this data shows statistical significance regarding the unexpected results of the instantly claimed invention (Remarks, paragraph bridging page 7-8). This is not persuasive.
This data is not included in the specification. In order to be considered as evidence of unexpected results, this data would need to be included in a declaration. However, if it were submitted in a declaration, this graph does not make clear that the statistical significance is determined in comparison of the claimed composition in comparison with the prior art compositions, as it seems that the statistical difference is between two tested time points (24 versus 72 hours) rather than a comparison of the different compositions.
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/
Supervisory Patent Examiner, Art Unit 1693