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 3 and 7 have been canceled. Claims 9-12 previously were withdrawn. Accordingly, claims 1, 2, 4, 5, 6, and 8 are pending and under current examination.
Withdrawn Objections/Rejections
The objection to claims 5-8 is withdrawn in view of Applicant’s amendments to the claims.
The rejection of claims 1,2, and 4 under 35 U.S.C. 103 as being unpatentable over US 2018/0236215A1 (Liu et al., “Liu) in view of CH711092A2 is withdrawn in view of Applicant’s amendments to the claims. Subsequently, the following rejections relying thereon are also withdrawn: the rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over US 2018/0236215A1 (Liu et al., “Liu) in view of CH711092A2 as applied to claims 1, 2, and 4 above, and further in view of US 2020/0375873A1 (Shih et al., “Shih”); the rejection of claims 5, 6, and 8 under 35 U.S.C. 103 as being unpatentable over US 2018/0236215A1 (Liu et al., “Liu) in view of CH711092A2 as applied to claims 1, 2, and 4 above, and further in view of US 2015/0057604A1 (Arami et al., “Arami”); and the rejection of claim under 35 U.S.C. 103 as being unpatentable over US 2018/0236215A1 (Liu et al., “Liu) in view of CH711092A2 and US 2020/0375873A1 (Shih et al., “Shih”) as applied to claims 1-4 above, and further in view of US 2015/0057604A1 (Arami et al., “Arami”).
Response to Arguments
Applicant’s arguments filed 9/4/2025 (hereafter, “Remarks’) have been fully considered and are addressed as follows. Applicant’s delineation of the claim amendments and rejections previously issued as outlined on page 7 of Remarks is noted. Applicant’s delineation of the prior art cited as outlined on page 11 of Remarks is note as well.
As noted above, Applicant’s argument against the previously issued objection is persuasive in view of the claim amendments filed 9/4/2025.
Regarding the rejections under 35 U.S.C. 103, Applicant argues that none of Liu, AG, and Shih teach the claimed combination of three hyaluronic acids and the weight ratio thereof. In reply, Applicant’s argument has been fully considered but is not persuasive in view of the new grounds of rejection necessitated by amendments filed 9/4/2025, detailed below. Specifically, the previously cited references have been newly applied in a new combination and with new rationale in order to properly address the claims as amended.
Applicant takes the position that Liu requires a hydrophobically modified hyaluronic acid, but that histidine as in the instant claims is a hydrophilic amino acid; Applicant then concludes that one would not use histidine to form a hydrophobically modified hyaluronic acid and further concludes that Liu and Shih’s modified hyaluronic acids cannot be combined (see paragraph bridging pages 12 and 13 of Remarks). In reply, Applicant’s argument is not persuasive because there is no teaching away from the combination of a histidine-modified hyaluronic acid as in Shih with Liu’s combination of multiple hyaluronic acid or hyaluronic acid-derived components. Moreover, there is no claim language excluding the addition of a histidine-modified hyaluronic acid from being combined with a hydrophobic-modified hyaluronic acid since the prior art references considered together provided for compositions which are emulsions and therefore combining hydrophilic and hydrophobic components in a single topical formulation.
Applicant argues that the composition of the instant invention can be formed into needles having mechanical strength to penetrate skin, and Applicant contrasts this with the gel format of the AG composition and the miceller component of Shih, then concludes that one could not combine AG and Shih and then expect mechanical strength sufficient for needles, allegedly attributable to the instant invention. In reply, Applicant’s argument has been considered but is not persuasive in view of the evidence of record in combination with the particular claim language. A nexus between needle components and the components included in claim 1 has not been established; limitations are not imported from the specification into the claim.
Regarding groups of dependent claims 2 and 4 as well as claims 5, 6, and 8, Applicant argues that secondary references do not cure the aforementioned alleged deficiencies. In reply, this argument has been considered but is not persuasive in view of the new grounds of rejection presented below, wherein a new combination of references is applied against the claims as amended.
New Grounds of Rejection Necessitated by Amendments of 9/4/2025
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.
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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0236215A1 (Liu et al., “Liu) in view of US 2020/0375873A1 (Shih et al., “Shih”) and CH711092A2.
The claims are drawn to a composition comprising a low-molecular hyaluronic acid, a modified hyaluronic acid which is a histidine-modified hyaluronic acid, and a cross-linked hyaluronic acid, having weight ratios and features further recited in the claims.
Liu teaches formulations comprising an active ingredient for administration via a microneedle array product (see abstract, in particular). The formulations may include an active ingredient which is for instance a drug molecule or some other type of specific active agent (see [0013]) The formulations comprise a first dissolvable polymer or a plurality of dissolvable polymers (see [0014] and [0015]). In some embodiments, the at least one dissolvable polymer comprises hyaluronic acid, crosslinked hyaluronic acid, hydrophobically modified hyaluronic acid, or any combination thereof (see [0016] and [0156]). Hyaluronic acid having a low molecular weight can dissolve quickly in the skin to promote better delivery of the active ingredient, and low molecular weight hyaluronic acid such as hyaluronic acid having a molecular weight of about 5kDa or 10 kDa for instance may be included (see [0072], see also limitation of claim 2). Accordingly, Liu is considered to teach a low-molecular weight hyaluronic acid as well as a crosslinked hyaluronic acid in combination in a composition for topical application (see Liu [0132] for instance).
Liu does not teach a modified hyaluronic acid having a histidine modification in particular, as in claim 1 as amended. Shih cures this deficiency.
Shih teaches biomedical compositions for skin care and/or maintenance and delaying and/or inhibiting skin aging (see title, in particular) for instance by managing wrinkles of the skin (see [0003]). Shih’s formulations include hyaluronic acid components (see [0004] and [0005]) in the form of micelles (see [0017]) which may be prepared in the form of an emulsion for example (see [0033]). Shih’s micelles include a hyaluronic acid and/or a derivative thereof and a modified histidine which is grafted to at least one primary hydroxyl group of the hyaluronic acid and/or the derivative thereof (see [0017] and [0019]).
Liu and Shih are directed to topically applicable formulations comprising hyaluronic acid components wherein said formulations may be used to combat wrinkles in the skin. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the histidine-modified hyaluronic acid as taught by Shih into the formulations of Liu, with a reasonable expectation of success. One would have been motivated to do so in view of Liu general teachings of different forms of hyaluronic acid as providing desirable topical benefit and further in view of Shih’s teaching of histidine modification in particular to provide desirable skin care and/or maintenance benefits (see Shih claims 4 and 5 in particular). Moreover, one would have been motivated to perform additional routine optimization procedures as to how much of this component would be desirably and beneficially included in combination with the additional hyaluronic acid components of Liu, as is customary in the art. One would have been motivated to do so to optimize both formulation stabilization (i.e., emulsion stability as suggested by Shih) and to optimize skin benefit effects as well, starting with Shih’s suggested weight percentage amount (see Shih claim 3).
While Liu generally provides for a combination of components instantly claimed, Liu does not recommend a particular ratio of the components which are hyaluronic acid, crosslinked hyaluronic acid, and histidine-modified hyaluronic acid (see Liu [0132]). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to utilize these three components as suggested by Liu and Shih in a single embodiment and further to perform routine optimization procedures with regard to the particular ratio of each component one to another. CH711092A2 provides motivation for performing routine optimization procedures for adjusting the presence of the aforementioned hyaluronic acid components for their dissolvability parameters, as detailed below.
CH711092A2 teaches a dermocosmetic biorevitalizing kit for external use and rapid entry (see title and abstract, in particular). The kit comprises a gel and is topically applicable for the treatment of wrinkles for instance (see last paragraph page 1 of translation and first paragraph page 2 of translation) via topical application (see last paragraph page 2 of translation). A mixture of hyaluronic acid components may be present and may be selected from those including hyaluronic acid of various molecular weight categories including (a) hyaluronic acid with a molecular weight of 800 to 1200 Daltons, (b) hyaluronic acid having a molecular weight of 4000 to 6000 Daltons, as well as additional disclosed hyaluronic acid molecules having higher molecular weight (see page 3, paragraph 6 of translation) and further still may include a hyaluronic acid component which is crosslinked with a polymer.
Accordingly, one would have been motivated to adjust the relative presence of hyaluronic acid, crosslinked hyaluronic acid, and modified hyaluronic acid as in Liu and Shih based on CH711092A2’s suggestion that the particular molecular weight can be used to control dissolvability properties, where one reasonably would have expected the relative presence of each to influence the dissolvability of the final product as result effective variables. One reasonably would have expected success from doing so based on Liu’s teaching that various properties of these components can be modulated to adjust the release profile of the active ingredient from microneedles upon application of a microneedle array to the skin surface of a subject and that other dissolvable polymers can also be blended with hyaluronic acid to further modulate these properties (see [0059] of Liu). Based on Liu’s teaching of three components constituting a dissolvable hyaluronic acid component, one reasonably would have expected success from starting at using a 1:1:1 ratio of Liu’s three hyaluronic acid components in the embodiment addressed above and, from there, to perform routine optimization procedures so to achieve the desired dissolution properties and effects in accordance with the teachings of Liu and CH711092A2, including increasing the relative amount of increasing the histidine modified hyaluronic acid component. Shih recommends increasing the amount of micelle component on a weight ratio basis (see [0051]) as well as increasing the amount of histidine in the micelle where increased functional efficacy is desired in a topical formulation (see [0055], [0057] in particular). Doing so would have resulted in overlapping ratio ranges as those recited in the last two lines of claim 1. Moreover, “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).
Further regarding claim 4, the product-by-process language pertaining to the preparation of a formulation component included in claim 1, crosslinked hyaluronic acid, reasonably would have been expected to take place so to achieve the crosslinked hyaluronic acid component addressed above in claim 1 and prior to the inclusion of this crosslinked component.
Claims 5, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0236215A1 (Liu et al., “Liu) in view of US 2020/0375873A1 (Shih et al., “Shih”) and CH711092A2 as applied to claims 1, 2, and 4 above, and further in view of US 2015/0057604A1 (Arami et al., “Arami”).
The teachings of Liu and CH711092A2 have been delineated above. Neither of these teaches the further inclusion of a component as instantly recited.
Arami cures this deficiency. Arami teaches microneedle products for delivering cosmetic formulations to the skin (see abstract, in particular) including anti-wrinkle drugs (see [0087]). Hyaluronic acid is named among examples of anti-wrinkle ingredients useful (see [0090]). The formulations may include other functional ingredients such as antimicrobial agents such as benzethonium chloride (see [0093]) where antimicrobial benefits are desired. See also [0100].
Liu, CH711092A2, and Arami are all directed to products for anti-wrinkle benefit. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add benzethonium chloride as taught by Arami to the formulations of Liu and CH711092A2, with a reasonable expectation of success. One would have been motivated to do so to provide desirable antimicrobial benefit as taught by Arami and as reasonably understood from Arami’s teaching by an ordinary artisan that antimicrobial benefit may be conferred topically or may alternately be considered desirable for maintaining reduced microbial growth upon storage prior to use in a topical formulation.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617