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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 5, 2025 has been entered.
Response to Amendment
Applicant’s amendment to the claims filed November 5, 2025 has been entered. Claim 1 is currently amended. Claims 9-15 remain withdrawn from further consideration. Claims 1-8, 16 and 17 are under examination.
Claim Rejections - 35 USC § 103
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.
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 1-8, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 2018/0186117) in view of either one of Kannan et al. (US 2022/0354752; priority date of October 8, 2019) or Sato et al. (US 2017/0136157) and in view of any one of Locke et al. (US 11,969,317), Suzuki et al. (US 2013/0015092), Delury et al. (US 2022/0142820), Locke et al. (US 2020/0093646), Payne et al. (US 2015/0174284), Cassin (US 2010/0003344), or Ishida (US 6,467,621).
Regarding claim 1, Seo et al. teach a method to produce a packaged cosmetic product (Title; Abstract; paragraph [0001]; Figures 1, 4 and 5), comprising: a step of feeding a support film/release film (30) along a feed path (Figure 6 (30)), a step of electrospinning a composition based on polymer and biocompatible material/functional material (Figure 6); paragraphs [0040], [0056]-[0066], [0072]-[0073], in which an electrospun substrate absorbable by the skin (paragraphs [0003], [0042]-[0048], [0059]; Figure 3 (14); water-soluble material – paragraphs [0023], [0062], [0063]) is formed which is deposited directly on said fed support film (Figures 1 and 6; electrospun layer (10) is formed directly on layer (30)), and a step of packaging said electrospun substrate, wherein the packaging step comprises: a step of coating the electrospun substrate, in which a coating film is fed along the feed path and applied onto the support film so as to cover the electrospun substrate (Figures 1 and 6; film/layer (20) is applied generally onto the support film to cover layer (10)). Seo et al. teach the material can include a range of water-soluble materials including hyaluronic acid (paragraphs [0023], [0062] – any suitable water-soluble materials may be used, [0063]).
Seo et al. do not teach the packaging step further comprises applying the coating film onto the support film in a manner which further includes a step of reciprocally joining the support film and said coating film (e.g., bringing the support film and coating film into direct contact with each other to join them together and form a sealed package).
However, each of Locke et al. (Figure 2; col. 8, lines 9-20), Suzuki et al. (Abstract; Figures 1A, 1B, 2A, 2B, 6A and 6B), Delury et al. (Figure 1D; paragraph [0068]), Locke et al. (paragraph [0040] – last sentence; Figures 1-4), Payne et al. (Figure 31; paragraphs [0138], [0196]), Cassin (paragraph [0168]) and Ishida (Abstract; Figures 3A, 3B; col. 3, lines 33-42 for cosmetic materials; col. 6, line 22-col. 8, line 34) disclose analogous methods wherein corresponding support films and coating films which surround interiorly contained analogous materials are reciprocally joined in a packaging step.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Seo et al. and any one of the secondary references and to have reciprocally joined the corresponding support film and coating film in the method of Seo et al., as suggested by any one of the secondary references, for the purpose, as suggested by the references of protecting the product within the package to avoid external contamination and/or to reduce exposure to outside air and/or to reduce potential leakage or evaporation of active/functional/cosmetic/medical/therapeutic materials from the package.
Further, beyond rationale (G) as set forth above, exemplary rationales (A), (B), (C) and (D), as set forth in MPEP 2143, are reasonably understood to be instructive and applicable in this instance. Seo et al. teach the basic claimed process, but do not teach the packaging step includes forming a sealed package around the periphery/perimeter of the contained electrospun functional material/cosmetic material by bringing exterior layers together as claimed. Each of the secondary demonstrate that this is a known and effective packaging technique in the analogous art. One having ordinary skill in the art would have recognized that the results of the combination were predictable and would have found it prima facie obvious to have sealed the package of Seo et al. in this way.
Seo et al. teach the material can include a range of water-soluble materials including hyaluronic acid (paragraphs [0023], [0062] – any suitable water-soluble materials may be used, [0063]), but do not teach utilizing hyaluronic acid together with pullulan.
However, each of Kannan et al. (Abstract; paragraphs [0002], [0015], [0052] – electrospinning combinations of materials including hyaluronic acid and pullulan, [0065], [0068] – preferably selecting hyaluronic acid, pullulan and combinations thereof, [0069], [0072], [0087] – analogous applications, [0094], [0096]-[0108], claims 3 and 4) and Sato et al. (Abstract – layer (B); paragraphs [0017], [0082], [0083] – both hyaluronic acid and pullulan are preferably used materials for their spinnability and are set forth in a small list of materials that are disclosed as being usable in combination with each other) teach analogous electrospinning methods where hyaluronic acid and pullulan are disclosed and are also disclosed as being suitably used together.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Seo et al. with either one of Kannan et al. or Sato et al. and to have utilized a composition comprising hyaluronic acid and pullulan as the water-soluble composition of Seo et al., as suggested by either one of Kannan et al. or Sato et al., for the purpose, as suggested by the references, of utilizing compositions known to be suitable for the intended purpose, that provide an intended benefit/functionality to the product (e.g. paragraphs [0065] and [0072] of Kannan et al.), and that are able to be effectively electrospun as fibers.
Further, as set forth in MPEP 2144.06 I, combining art recognized equivalents known to be useful for the same purpose in order to form a third composition to be used for the same purpose is prima facie obvious. In this case, the prior art establishes that both hyaluronic acid and pullulan are biocompatible water-soluble materials that may be electrospun and that they can be utilized for the same purpose in the prior art.
Further, the prior art set forth above in the body of the rejection teaches that combinations of these materials may be utilized. As such, combining them as claimed is understood to be prima facie obvious absent a clarifying amendment or evidence commensurate in scope with any assertion of new or unexpected results.
Alternatively, each of Kannan et al. and Sato et al. individually are reasonably understood to be a primary reference that can be modified by the teaching of Seo with the other alternatively applied secondary references to arrive at the claimed invention. In such a combination, the electrospun compositions of Kannan et al. or Sato et al. cited above provide the primary teaching directed to the claimed electrospun composition and the additional reference of Seo et al. (now as a secondary reference and as cited above for teaching directed to supporting and packaging electrospun compositions) taken with the alternatively applied additional references (relied upon for the same reasons) provide a teaching and suggestion to package the compositions of either of Kannan et al. or Sato et al. in the claimed manner. The motivation to combine the teachings in the reverse order is to effectively package and prepare the electrospun compositions of Kannan et al. of Sato et al. for storage, shipping, and use. In the combinations, in either direction, each and every limitation of the claims is taught and suggested.
As to claims 2, 3, and 16 as set forth and described above, the combination of Seo et al. with any one of the secondary references is understood to join the films in zones which are in reciprocal contact and they are joined in a manner that forms an internal space which encloses the electrospun substrate as claimed. The reason to combine the references is the same as that set forth above.
As to claims 4 and 17, it implicitly follows from the combination as set forth above that the packaged product of Seo et al. would be cut as claimed. This is not explicitly shown in all the secondary references, but it is understood to be reasonably suggested by them. Further, each of Ishida (Figure 4; col. 7, lines 14-col. 8, line 34) and Payne et al. (Figure 31 (2924) (2926)) explicitly teach the claimed limitation. The reason to combine the references is the same as that set forth above and the packaged product would be cut as claimed to provide a single product that is in condition for use and/or individual sale.
As to claims 5-8, Seo et al. teach the material can include polysaccharides such as starch, hyaluronic acid, carboxy methyl cellulose and mixtures of these materials (paragraph [0023]). A mixture of these materials is understood to disclose first and second polysaccharides as claimed. It is noted that the same claimed materials are suggested for use, even if applicant’s reasons for selecting the same materials is different, a prima facie case of obviousness exists because any advantage would flow naturally from following the suggestion of the prior art. Further, Kannan et al. (Abstract; paragraphs [0002], [0015], [0052], [0065], [0068], [0069], [0072], [0087], [0094], [0096]-[0108], claims 3 and 4) and Sato et al. (Abstract – layer (B); paragraphs [0017], [0082], [0083]) suggest additional materials as claimed beyond pullulan and are combined with Seo et al. for the same reasons set forth above. Similar to the rejection of claim 1, these claims are also properly rejected in reverse order where either one of Kannan et al. or Sato et al. provides the primary teaching directed to the claimed compositions and Seo et al. with the additional references are combined with the primary teaching to provide a teaching and reason for packaging, storing and preparing the composition for use in the claimed manner.
Response to Arguments
Applicant’s arguments filed November 5, 2025 have been fully considered. The arguments and amendments have overcome the previous rejections. As set forth above, new grounds of rejection have been made. To the extent the argument remains applicable, the argument that Seo does not teach an electrospun substrate that is absorbable by the skin has been fully considered, but is not persuasive. Seo electrospins a water-soluble material and this material is distinct from the other materials. The water-soluble material of Seo et al. is reasonably understood to read upon the claimed electrospun substrate. For example, Figure 3 shows (14) as an outer layer of the water-soluble material and paragraphs [0042], [0045], and [0046] teach the water-soluble material may be laminated to the other materials. These water-soluble components are absorbable by the skin and read upon the claimed composition based on polymer and biocompatible material that is electrospun into a substrate as claimed absent further specificity (also see paragraphs [0003], [0019]-[0023], [0047], [0048], [0059], [0062] and [0063]). Further, Seo makes clear that a range of water-soluble materials may be employed, as desired and not limited to the exemplary materials (paragraphs [0023], [0062] and [0063]) and this teaching provides a reasonable basis for combination with the secondary references that teach and suggest both hyaluronic acid and pullulan for use together as water soluble materials.
It is noted as set forth above that each of Kannan et al. (US 2022/0354752) and Sato et al. (US 2017/0136157) individually are reasonably understood to be a primary reference that can be modified by the teaching of Seo with the other alternatively applied secondary references to arrive at the claimed invention. In such a combination, the electrospun compositions of Kannan et al. or Sato et al. provide the primary teaching directed to the claimed electrospun composition that is electrospun as a substrate that is absorbable by the skin and the additional reference of Seo et al. (now as a secondary reference) taken with the alternatively applied additional references provide a teaching and suggestion to package the compositions of either of Kannan et al. or Sato et al. in the claimed manner. The motivation to combine the teachings in the reverse order is to effectively package and prepare the electrospun compositions of Kannan et al. of Sato et al. for storage, shipping, and use. In combination, each and every limitation of the claims is taught and suggested.
It is submitted the claims would need to be further amended to overcome the prima facie case of obviousness. As to arguments directed to new or unexpected results, it is noted that the arguments do not appear to be commensurate in scope with the claimed invention (e.g. amounts of hyaluronic acid in the composition are not claimed and the claims remain open to a broad reasonable interpretation and do not exclude other materials).
Further, as set forth in MPEP 2144.06 I, combining art recognized equivalents known to be useful for the same purpose in order to form a third composition to be used for the same purpose is prima facie obvious. In this case, the prior art establishes that both hyaluronic acid and pullulan are biocompatible materials that may be electrospun and that they can be utilized for the same purpose in the prior art. Further, the prior art set forth above in the body of the rejection teaches that combinations of the materials may be utilized. As such, combining them as claimed is understood to be prima facie obvious absent a clarifying amendment or evidence commensurate in scope with any assertion of new or unexpected results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sandri et al. (US 2020/0230290) disclose an analogous electrospun composition (paragraphs [0029], [0038]-[0054], [0092]-[0096] – same claimed starting materials, [0118] – composition is insoluble).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742