DETAILED ACTION
Notice of Pre-AIA or AIA Status
Status of Application
Receipt of Applicants’ Arguments, Remarks and amended claims filed on 07/07/2026 is acknowledged. Claims 1, 4-10, and 17-21 are pending. Claim 22 is new.
Claims 1, 4-10, and 17-22 are pending and under examination in this application. This action is NON-FINAL. This action introduces additional prior art directly supporting the composition limitations of claim 1 and claim 17 that were not separately articulated in the prior Office action, and is issued in response to Applicant's remarks and amendment filed 07/07/2026.
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, 4-10, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shiratori (JP 2008179629) in view of Sandri et al. (WO 2019/021325 A1, corresponding to US Patent No. 11,801,328 B2, hereinafter "Sandri"); Saquing et al., (Alginate-Polyethylene Oxide Blend Nanofibers and the Role of the Carrier Polymer in Electrospinning, hereinafter “Saquing”); further in view of Vicini et al., (Alginate and alginate/hyaluronic acid membranes generated by electrospinning in wet conditions: Relationship between solution viscosity and spinnability, hereinafter “Vicini”); and further in view of and further in view of Witting et al., (Interactions of Hyaluronic Acid with the Skin and Implications for the Dermal Delivery of Biomacromolecules, hereinafter “Witting”).
Shiratori teaches a cosmetic sheet for skin comprising cosmetic ingredients on a network structure composed of nano-fibers of a polymeric compound (abstract).
Regarding claim 1, Shiratori teaches electrospinning method of a cosmetic sheet network structure composed of nanofibers comprising pullulan or hyaluronic acid, polymers, collagen, PVA copolymer, cellulose acetate, … polyethylene terephthalate and cosmetic ingredients (¶ 0006 - ¶ 0011, and claims 1 and 7--9). Shiratori further teaches that the nanoweb holds cosmetic, pharmaceutical, or nutritional ingredients by mixing the ingredient into the polymer solution prior to electrospinning, or by encapsulation within the nanofiber (¶ 0013-0014).
Vicini remedies this gap with respect to the alginate alternative. Vicini teaches ternary systems of sodium alginate (SA), poly(ethylene oxide) (PEO), and hyaluronic acid (HA) co-electrospun into a single membrane, at a weight ratio of 60:30:10 (SA:PEO:HA) at 4 wt% total polymer concentration (page 3, left column, ¶ 4; page 6, right column, last ¶; Table 1). This is a single electrospun fiber composition comprising hyaluronic acid together with alginate, and therefore satisfies the limitation that "the electrospinning promoter comprises at least one of pullulan and alginate" directly, without requiring selection of discrete polymers from separate lists in a single reference.
Sandri remedies this gap with respect to the pullulan alternative. Sandri teaches an aqueous composition to be electrospun comprising hyaluronic sodium salt and pullulan, dissolved together and co-electrospun in a single solution (Sandri, pg. 8, line 6 - pg. 9, line 3, Composition 5). Sandri thus teaches co-electrospinning hyaluronic acid together with pullulan within a single fiber composition, directly satisfying the pullulan alternative of the "electrospinning promoter" limitation.
Sandri remedies this gap with respect to the pullulan alternative. Sandri teaches an aqueous composition to be electrospun comprising hyaluronic sodium salt and pullulan, dissolved together and co-electrospun in a single solution (Sandri, pg. 8, line 6 - pg. 9, line 3, Composition 5). Sandri thus teaches co-electrospinning hyaluronic acid together with pullulan within a single fiber composition, directly satisfying the pullulan alternative of the "electrospinning promoter" limitation.
It would have been obvious to a person having ordinary skill in the art (POSITA) before the effective filing date to modify Shiratori's cosmetic patch by forming its nanoweb from an electrospun fiber comprising hyaluronic acid together with alginate (as taught by Vicini) or hyaluronic acid together with pullulan (as taught by Sandri), rather than a single polymer selected in isolation. A POSITA would have been motivated to do so because Saquing establishes that natural polysaccharides such as alginate are difficult to electrospin alone and benefit from a co-polymer that provides molecular entanglement and favorable solution conductivity (Saquing, abstract), and because Vicini and Sandri each demonstrate that hyaluronic acid can be successfully co-electrospun with alginate or pullulan, respectively, into stable, structurally sound fiber membranes suitable for topical or wound-care application. A POSITA would therefore have had a reasonable expectation of success in combining Shiratori's cosmetic-sheet concept with the specific HA/alginate or HA/pullulan compositions of Vicini and Sandri.
Regarding claim 4, Shiratori teaches non-woven fabric form of the electrospun nanoweb fibers (¶ 0016).
Regarding claim 5, Shiratori teaches fiber diameter in the range of 30 to 2000 nm (¶ 0009). Therefore, the limitation of the electrospun fiber having a diameter smaller than 100 µm is taught.
Regarding claim 6, Shiratori teaches that cosmetic ingredients are mixed into the polymer compound solution and electrospun, such that the active ingredient is integrated within the electrospun fiber (¶ 0013).
Regarding claim 7, Shiratori teaches holding cosmetic ingredients within the interior of the nanoweb structure (encapsulation) as well as on its surface (¶ 0013).
Regarding claim 8, Shiratori teaches anti-inflammatory ingredients including turmeric extract, ginger extract, and menthol among the cosmetic ingredients that may be held by the nanoweb (¶ 0014). Therefore, the limitation that the active ingredient comprises a non-steroidal anti-inflammatory and/or one or more analgesics is taught.
Regarding claims 9-10, Shiratori teaches preparing the nanofiber sheet on the surface of a support base material (wrap), wherein the base material promotes penetration of the cosmetic into the skin by a sealing effect (¶ 0025). Therefore, the limitations directed to an article comprising the patch product disposed on a support base, and a wrapping providing protection for the patch product, are taught.
Regarding claim 17, the electrospinning promoter is pullulan alone (no alginate alternative). As set forth above, Sandri teaches a composition comprising hyaluronic sodium salt and pullulan (food grade) dissolved and co-electrospun together in a single aqueous solution (page 8, line 6 - page 9, line 3, Composition 5). Combining this teaching with Shiratori's cosmetic patch structure, for the reasons and with the motivation set forth above with respect to claim 1, renders claim 17 obvious.
Regarding claim 18, Saquing teaches that fiber formation is realized at an alginate:PEO ratio between 40:60 and 50:50 (¶ Conclusions), corresponding to the limitation that the electrospinning promoter is a mixture of alginate and polyethylene oxide (PEO) in a weight ratio of approximately 1:1.
Regarding claims 19-21, Vicini teaches ternary SA/PEO/HA systems prepared at weight ratios including 60:30:10 (SA:PEO:HA) (page 3, left column, ¶ 4; page 6, right column, last ¶), and further teaches that the polymer ratio was deliberately modified from an initial 33:33:33 ratio to 60:30:10 in order to satisfy viscosity and electrospinnability requirements (page 6, right column, last ¶). This demonstrates that the relative weight ratio of hyaluronic acid to electrospinning promoter is a result-effective variable known in the art to be adjusted to achieve stable, homogeneous, electrospinnable fibers. A POSITA would have been motivated to routinely optimize this ratio within the claimed ranges (10:1 to 1:10; 4:1 to 1:7; and 3:1 to 1:6, respectively) to balance mechanical integrity, biocompatibility, and electrospinnability, with a reasonable expectation of success. See In re Aller, 220 F.2d 454 (CCPA 1955); MPEP § 2144.05.
Witting teaches that the molecular weight of hyaluronic acid is a controlling variable governing HA's ability to penetrate the stratum corneum and enhance dermal absorption, comparing HA fractions of approximately 5 kDa, 100 kDa, and 1 MDa, with lower-molecular-weight HA showing enhanced penetration behavior relative to higher-molecular-weight HA (abstract; p. 1395, left column, ¶ 2; p. 1398, right column, last ¶).
Regarding claim 22, the claim recites that the hyaluronic acid has a molecular weight of less than 10,000 Da. Witting establishes that HA molecular weight is a result-effective variable directly controlling skin/stratum corneum penetration (MPEP § 2144.05; In re Aller, 220 F.2d 454 (CCPA 1955); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990)). A POSITA seeking to optimize the patch product of claim 1 for effective delivery of the active ingredient into the skin would have been motivated to select a hyaluronic acid molecular weight below 10,000 Da, consistent with Witting's teaching that lower-molecular-weight HA fractions (e.g., approximately 5 kDa) enhance penetration relative to higher-molecular-weight HA, and would have had a reasonable expectation of success given that claim 1's composition already includes an electrospinning promoter (pullulan or alginate, per Vicini and Sandri) that provides the molecular entanglement needed to electrospin HA regardless of the HA fraction's molecular weight. The combination therefore amounts to no more than the routine optimization of a recognized result-effective variable to achieve a predictable result. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive, for the reasons below.
A. Regarding the Limitation "a membrane substrate absorbable by the skin" (Claim 1)
Applicant argues that Shiratori merely discloses a cosmetic sheet carrying active ingredients rather than a membrane substrate that itself is absorbable by the skin within minutes, citing the specification's disclosure that the membrane is "completely absorbed by the skin, together with the active ingredient present" within "just a few minutes" (Specification, ¶ [0030]).
Examiner respectfully disagrees. As an initial matter, claim 1 does not recite that the membrane is "completely" absorbed, nor does it recite any timeframe such as "a few minutes." These are disclosed embodiment characteristics found only in the specification and are not claim limitations. Under the broadest reasonable interpretation consistent with the specification (MPEP § 2111), Applicant may not import unclaimed, more specific characteristics of a preferred embodiment into the broader claim term "absorbable by the skin" to distinguish over the prior art.
Further, and independent of the above, Shiratori's nanoweb is formed from water-soluble, skin-compatible polymers including pullulan and hyaluronic acid, and is designed for direct skin application such that cosmetic ingredients are "gradually absorbed" by the skin upon use with added water, lotion, or oily cosmetic (¶ 0013, ¶ 0015). A nanofiber web composed of such water-soluble polymers, applied to moist skin, inherently exhibits the capability of being absorbed by the skin. Applicant has not presented comparative evidence (e.g., under 37 CFR 1.132) demonstrating that the claimed membrane exhibits an unexpected or patentably distinct absorption property relative to Shiratori's water-soluble nanofiber sheet.
B. Regarding the Electrospun Fiber Composition (Claim 1)
Applicant argues that the cited references, individually or in combination, do not teach or suggest co-electrospinning hyaluronic acid together with pullulan or alginate as an electrospinning promoter within a single fiber, and that Shiratori's separate listing of these polymers as alternatives does not supply the requisite teaching or motivation to combine them.
Examiner respectfully agrees that Shiratori's list of candidate fiber-forming polymers, standing alone, does not by itself teach combining any two members of that list. However, this argument is now moot in view of the additional prior art applied above. Vicini expressly teaches a ternary composition in which hyaluronic acid and alginate are co-electrospun together within a single fiber membrane (SA:PEO:HA at 60:30:10), which is not a matter of selecting discrete members from separate lists but an express, working combination. Sandri likewise expressly teaches a composition in which hyaluronic sodium salt and pullulan are dissolved and co-electrospun together within a single fiber (Sandri, pg. 8, line 6 - pg. 9, line 3). Sandri and Vicini therefore each independently supply the missing teaching that Applicant correctly identified as absent from Shiratori standing alone, and each does so through an express working example rather than through selection from a Markush-type list.
Nor does Hyeong cure this gap. Hyeong's hydrophilic base layer (layer A+B) is formed from chitosan, pullulan, gelatin, γ-PGA, or alginate mixed with polyvinylpyrrolidone (claim 1(a); page 5). Hyaluronic acid, by contrast, appears only as an optional component (D) of Hyeong's separate hydrophobic layer, where it may be added to a biodegradable synthetic polymer such as PLGA, PCL, or PGA (page 6). These two layers are prepared as separate polymer solutions and electrospun sequentially in distinct steps, the hydrophobic layer being deposited only after the hydrophilic layer is already formed (claim 8(e)-(f); page 7). Hyeong therefore does not teach or suggest combining pullulan and hyaluronic acid within a single electrospun fiber; to the contrary, Hyeong's own design deliberately keeps these two polymers in structurally and compositionally separate layers with different functions (hydrophilic wound-contact layer versus hydrophobic barrier layer). Sandri's teaching of hyaluronic acid and pullulan dissolved and co-electrospun together within a single solution (Sandri, pg. 8, line 6 - pg. 9, line 3) thus supplies a teaching that is absent from, and not suggested by, Shiratori or Hyeong individually or in combination.
C. Regarding the molecular weight of hyaluronic acid (new Claim 22)
Applicant argues that Vicini's HA is high molecular weight (approximately 700 kDa to 2,000 kDa) and that the cited art does not suggest a hyaluronic acid molecular weight of less than 10,000 Da.
Examiner respectfully disagrees for the reasons set forth above in the rejection of claim 22. Witting establishes that HA molecular weight is a recognized result-effective variable controlling stratum corneum penetration and dermal absorption, such that a POSITA would have been motivated to select a molecular weight below 10,000 Da to optimize skin penetration of the claimed patch product, independent of the specific molecular weight used by Vicini for its electrospinnability studies. See MPEP § 2144.05.
Applicant's arguments have been fully considered but are unpersuasive for the reasons stated above. Claims 1, 4-10, and 17-22 stand rejected under 35 U.S.C. 103.
Conclusion
No claims are allowed.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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