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 Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/22025 has been entered.
Claims 1, 4-10, and 17-21 are pending and under examination in this application.
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 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Shiratori (JP 2008179629) in view of Saquing (Alginate-Polyethylene Oxide Blend Nanofibers and the Role of the Carrier Polymer in Electrospinning), Hyeong (KR 101578535 B1) and further in view of Vicini (Alginate and alginate/hyaluronic acid membranes generated by electrospinning in wet conditions: Relationship between solution viscosity and spinnability.
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 - ¶ 0008, and claims 1 and 7--9) and alginate (¶ 0014). Therefore, the structural features and limitations of a cosmetic patch product of an electrospun fiber comprising pullulan, hyaluronate acid and alginate is taught.
Regarding claim 5, Shiratori teaches non-woven fabric form of the electrospun nanoweb fibers (¶ 0016).
Regarding claim 6, 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 7, Shiratori teaches in the cosmetic sheet comprising the nanoweb is made to hold cosmetics or ingredients holding inside the nanoweb, holding (encapsulating) in the nanofiber, and combining these holding forms and the cosmetic ingredients are mixed into the polymer compound solution and electrospun (¶ 0013).
Regarding claim 8, Shiratori teaches anti-inflammatory (¶ 0006) and turmeric, ginger extract, and menthol (¶ 0014). Therefore, the limitations of the at least one active ingredient comprises an anti-inflammatory and/or one or more analgesics are explicitly taught.
Regarding claims 9-10, Shiratori teaches support base material and the nanofiber sheet was prepared on the surface of the substrate (wrap) and the reason for covering with the base material (wrap) is to promote the penetration of the cosmetic into the skin by the sealing effect (¶ 0025). Therefore, the limitation of protection for the patch product and support base are taught.
Regarding claim 17, Shiratori teaches pullulan, hyaluronic acid and polyethylene oxide (PEO) (claim 7, ¶ 0006, ¶ 0011) and methods of manufacturing the cosmetic sheet comprising the above ingredients via electrospinning the nanowebs fibers (¶s 0011-0026). Thus, the subject matter of a patch product comprising a membrane substrate absorbable by the skin with at least one active ingredient, formed via at least one electrospun fiber comprising hyaluronic acid and the electrospinning promoter comprising pullulan and alginate, and wherein the active ingredient is at least one selected from the group consisting of cosmetic, pharmaceutical and nutritional active ingredients are explicitly taught.
However, Shiratori fails to specifically teach the claimed ratios of alginate, PEO, and HA.
Saquing teaches why aqueous sodium alginate can only be electrospun into fibers through a blend with another polymer; specifically, polyethylene oxide (PEO) as the “carrier polymer” and the addition of PEO favorably reduces electrical conductivity and surface tension of the alginate solution, aiding in fiber formation and While PEO has the ability to coordinate through its ether group (−COC−) with metal cation like the sodium cation of sodium alginate, we demonstrate in this study using PEO as well as polyvinyl alcohol (PVA) that coordination may have little effect on electrospinnability. More importantly, we show that PEO as carrier polymer provides molecular entanglement that is required for electrospinning (abstract).
Regarding claim 18, Saquing teaches fiber formation is realized at an alginate: PEO ratio between 40:60 and 50:50 (¶ conclusions) corresponding to the limitation of the electrospinning promoter is a mixture of alginate and polyethylene oxide (PEO) in a weight ratio of 1:1.
Hyeong teaches multi-layered nanofibrous structure manufactured by electrospinning method comprising hydrophilic natural polymer chitosan and the like, wherein the method comprises electrospinning a mixed polymer solution including a biodegradable natural polymer to form a hydrophilic substrate layer on non-woven fabric (abstract).
Regarding claim 8, Hyeong teaches non-steroidal anti-inflammatory and/or one or more analgesics (page 6, ¶ 5).
Regarding claims 19-21, Hyeong teaches pullulan, alginate mixed in a nanofiber structured hydrophilic base layer obtained by electrospinning a hydrophilic mixed polymer solution (page 3, ¶ In the present invention), and the biodegradable synthetic polymer solution in step (c), at least one biodegradable hydrophilic polymer (D) selected from polyethylene glycol and polyvinyl pyrrolidone is added to make it hydrophobic, preparing a mixed polymer solution (C+D) and (e) electrospinning the hydrophilic mixed polymer solution (A+B) prepared in the step (b) to obtain a nanofibrous hydrophilic base layer, and (f) comprising a step of laminating a hydrophobic layer of nanofiber structure by electrospinning the hydrophobic mixed polymer solution (C+D) prepared in step (d) on the hydrophilic substrate layer obtained in step (e), A method of manufacturing a nanofibrous multi-layer adhesion preventing film is provided (page 4, ¶ c-d). Moreover, Hyeong teaches as the hydrophilic polymer (D) added to the biodegradable synthetic polymer (C) of the present invention, poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA), PVP, gelatin, silk fibroin , Collagen, cellulose, alginic acid and hyaluronic acid may be used alone or in combination (page 6, ¶ 2). Hyeong further discloses
the hydrophilic natural polymer (A) is one or more selected from the group consisting of chitosan, fluran (pullulan), gelatin (gelatin), γ-PGA [Poly(γ-glutamic acid)] and alginate (alginate), Preferably it can be chitosan (page 5, ¶ 4), and the ratio of the biodegradable synthetic polymer (C) to the biodegradable synthetic polymer (C) is preferably 10 to 20 parts by weight of the biodegradable hydrophilic polymer (D) relative to 100 parts by weight of the biodegradable synthetic polymer (C). If it is less than 10 parts by weight, there is a problem in adhesion of the multi-layered nanofibers, and if it exceeds 20 parts by weight, the biodegradation period is short, which may degrade the efficiency for adhesion prevention. Even when using PLGA and PEG or PVP, PEG or PVP is
preferably 10 to 20 parts by weight relative to 100 parts by weight of PLGA. If it is less than 10 parts by weight, there is a problem of adhesion between nanofibers of a multi-layered structure, and when it exceeds 20 parts by weight, it may be difficult to control the biodegradation period, and the anti-adhesion film of the present invention may further include a drug as necessary. The drug can be added to all layers, and preferably, may be included in a hydrophilic mixed polymer solution (A+B) forming the
hydrophilic layer or a hydrophobic mixed polymer solution (C+D) forming a hydrophobic layer. The drugs included are, for example, anti-inflammatory drugs, antibiotics, and anti-cancer drugs (page 6, ¶ 2-4).
Vicini teaches the methodology to create alginate and alginate/hyaluronic acid membranes, which involves wet conditions electrospinning, wherein the wet conditions allow simultaneously to work in water solutions avoiding the toxic solvents and
to obtain crosslinked alginate. An accurate rheological characterization of all solutions examined is performed, and by optimizing the electrospinning parameters, it is possible to obtain alginate membranes with homogeneous nanofibers and a narrow diameter distribution (i.e., around 100 nm) as well as alginate/hyaluronic acid membranes characterized by a network of bimodal distribution of the dimensions, namely nanofibers with a diameter comparable to the ones of the alginate membrane, in which are blocked microfibers with a ribbon like appearance. In order to facilitate the electrospinning process, poly(ethylene oxide) is added to the solutions and then removed after membranes preparation (abstract).
Regarding claim 18, Vicini teaches sodium alginate (SA) and poly(ethylene oxide) (PEO) solutions were mixed and gently stirred to prepare homogeneous binary systems SA/PEO at a total polymer concentration of 4 wt %. The two polymers were mixed at the weight ratios of 50:50, 60:40, and 70:30 (page 3, left column, ¶ 3; page 4 left column, last ¶).
Regarding claims 19-21, Vicini teaches ternary systems SA/PEO/HA were prepared at a total polymer concentration of 1.5, 2, and 4 wt %, and at the concentrations of 1.5% and 2%, the polymers were mixed at the weight ratio of 33:33:33 using the HMW-HA, and at the total polymer concentration of 4 wt %, the polymers were mixed at the weight ratio of 60:30:10 with both molecular weights of hyaluronic acid, and 1 wt % of Triton X-100 was also added to these preparations (page 3, left column, ¶ 4 and table 1). Furthermore, Vicini discloses binary system SA/PEO at different concentrations (i.e., 1.5, 2, and 4 %) (table 1). Moreover, Vicini discloses Alginate/Hyaluronic Acid Membranes, and the 2 wt % ternary systems
(SA/PEO/HMW-HA 33:33:33) satisfied the electrospinning parameters from a viscosity point of view (Table I), and despite the fact that other combinations of electrospinning
parameters were tested, it was not possible to achieve homogeneous fibers, free of defects with ternary systems at 2 wt %. As result of this, 4 wt % of total polymer concentration was taken into account. In this case it was necessary to modify the polymers ratio from 33:33:33 to 60:30:10 in order to satisfy the viscosity requirement, choosing the same amount of SA of the binary systems already experimented in the production of alginate membranes (page 6, right column, last ¶). This suggests that the subject matter of the electrospinning promoter is a mixture of alginate/PEO and/or alginate and hyaluronic acid (HA) is known, able to modify, and taught and it would have been obvious for a person having ordinary skill in the art to adjust/optimize the weight ratios of the electrospinning promoter and HA in order to achieve stability, homogenous, biocompatibility, with good mechanical and absorption properties.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate a patch product comprising a membrane substrate, wherein the membrane substrate is formed by at least one electrospun fiber and that the active ingredient is integrated in the membrane as taught by Shiratori in view of Saquing and further in view of Hyeong. One would have been motivated to do so because the combined teachings of Shiratori in view of Saquing and further in view of Hyeong discloses compositions and methods for a patch product that can be absorbed by the skin, and based on biocompatible polymer compounds, consisting of electrospun nanofibers, pullulan, alginate and PEO. One would have been motivated to incorporate mixture of alginate and polyethylene oxide (PEO) in order to enable the electrospinning process, and spinning aid polymers to entanglement as taught by Saquing in view of Vicini and further incorporate pullulan, alginate and optimize ratios in order to achieve good mechanical, electrospinning and absorption properties as taught by Hyeong in view of Vicini. One of ordinary skill in the art would have been motivated to combine anti-inflammatory and/or analgesics active ingredients of Hyeong with Shiratori or Saquing patch/sheet composition because both references are drawn to methods for manufacturing a patch product to be absorbed by the skin with an active ingredient. One of ordinary skill in the art would have found it obvious to apply the different methods of manufacturing the patch product to improve absorption of the active ingredient for use in wound healing to improve the effectiveness in treatment as taught by all the above references.
It is obvious to combine prior art elements according to the known methods to yield predictable results. Please see MPEP 2141 (III)(A)-(G).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. Examiner respectfully disagrees with applicants’ arguments that the cited prior art in the Final office action filed 08/22/2025 failed to teach pullulan as electrospun material, electrospun promoter, HA and alginate. However, in view of applicants arguments, newly cited prior art of record are applied to the rejections above for clarity in the subject matter of claimed invention.
Conclusion
No claims are allowed.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615