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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3, 5, 7, 9, 11, 12, 14, 17, 18, and 68 as well as newly added claim 77, in the reply filed on 2/19/2026 is acknowledged.
Claims 19, 22, 28, 34, 36, 37, 43, 51, 53, 56, 61, 62, 64, 70, and 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected products and methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/19/2026.
Accordingly, claims 1, 3, 5, 7, 9, 11, 12, 14, 17, 18, 68, and 77 are under current examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/6/2024 and 3/27/2024 have been considered by the examiner.
Claim Objections
Claim 68 is objected to because of the following informalities: claim 68 requires all limitations of claim 19 which is not under current examination as a result of the restriction requirement and subsequent election. Appropriate correction is required.
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, 3, 5, 18, 68, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0399430A1 (Maharjan et al.; hereafter “Maharjan”) in view of US 2020/0352990A1 (Brown et al.; hereafter “Brown”).
The elected claims are drawn to a method for preparing a temperature-sensitive hydrogel for administration to the skin of a subject in need thereof, comprising aerosol mixing (a) a first solution comprising water and (b) a second solution, to form a hydrogel; wherein the second solution comprises an organic solvent and a polymer comprising a copolymer of a first monomer and a second monomer as further specified in the claims. It is noted that the administration to skin is interpreted an intended use of the product encompassed in the instantly elected process of making a hydrogel product.
Maharjan discloses a temperature-sensitive hydrogel system (see paragraphs [0074], [0079]-[0082], [0087], and [0090] as well as Example 9). Maharjan specifies poly N-isopropylacrylamide as a thermo-responsive hydrogel that shows different water absorption behavior as a function of temperature (see [0074]). Example 9 discloses an embodiment including poly N-isopropylacrylamide (PNIPAM) in ethanol (limitation of claim 18) aqueous solution. It is noted that ethanol is considered an organic solvent. Paragraph [0079] shows the F-PNIPAM copolymer has a first monomer of CH2-CHRaCNHR1 with Ra = H and R1=isopropyl, and methylenebisacrylamide and 1H,1H,2H,2H_perfluorodecyl acrylate as additional monomers in the copolymer.
Maharjan teaches all elements instantly claimed except the stepwise aerosol mixing of a first solution comprising water and the second solution as claimed, as otherwise addressed above in combination in a temperature-sensitive hydrogel product.
Brown teaches the state of the art with regard to NIPAM copolymers by its teaching of microgels of poly(N-alkylacrylamide) copolymers (see [0072]) for promoting wound healing upon topical application (see [0036]-[0042]). Brown teaches that the formulations may be administered by spray or aerosol topically (see [0049] and [0065]-[0068]).
Regarding claims 1 and 3, Maharjan and Brown both pertain to polyacrylamide copolymers including NIPAM components. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to make by mixing and to administer a topical hydrogel as in Maharjan by Brown’s method of aerosol application, with a reasonable expectation of success. One would have been motivated to do so to facilitate combination of formulation components for topical application as taught by Brown. Brown’s disclosure describes a “spray deposition (SD) applicator” as recited in claim 5.
Regarding claim 68, its limitations have been addressed above in regard to claim 1. While claim 68 is noted to depend from claim 19, claim 19 is not under current examination, and limitations are not imported from the specification into the claim beyond those elements addressed above in regard to claims overlapping in scope. Limitations of new claim 77 have been addressed above in regard to claim 1.
Claims 7, 9, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0399430A1 (Maharjan et al.; hereafter “Maharjan”) in view of US 2020/0352990A1 (Brown et al.; hereafter “Brown”) as applied to claims 1, 3, 5, 18, 68, and 77 above, and further in view of KR 10-2062093 (“Jeong”).
Regarding claims 11 and 12, the aforementioned references do not teach the claimed mesh or support component. Nor does the combination of Maharjan and Brown teach the recited amounts of water and polymer or evaporation step in a process of making. Jeong cures these deficiencies.
Jeong teaches a self-transforming mask pack and method of its manufacture (see title, in particular). Jeong’s product includes a temperature sensitive material which may be NIPAM (page 5/16 of translation, paragraph 6) as a hydrogel component at 20% w/v (see page 11/16, paragraph 4 of translation)(limitation of claim 9) wherein the prepared hydrogel layer is immersed in distilled water, swelled, and dried (page 8/16 of translation, paragraph 9, starting “Experimental example for the physical property analysis…”); this drying step is considered the same or substantially the same as the instantly claimed “evaporating” step (limitation of claim 11). Accounting for Jeong’s requisite components of monomer/polymer components and photoinitiator appears to, by deduction, teach an amount of water overlapping the range recited in claim 7 since all percentages must sum to 100% (see page 11/16 which teaches for instance Fig. 8 including Aam concentration up to 20%, NIPAM up to 20%, MBA 0.01 to 2%, and a remaining percentage of hydrogel presumably being or including water).
Jeong’s hydrogel may be on top of a base material which may be considered fibrous (see page 5/16, paragraph 2 of translation)(limitation of claim 12). Jeong describes a temperature reduction step (see page 10/16, description of FIG 5c)(limitation of claim 14); it is noted that claim 14 structurally requires only a temperature reduction of the gel and not its intended use or the optional recited additional element.
Maharjan, Brown, and Jeong are all directed to NIPAM or similar hydrogel products and their methods of making. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to utilize amounts of water and polymer concentrations in a hydrogel product, evaporation to dry in a process of making, and addition of a fibrous support structure for a hydrogel as taught by Jeong for the particular hydrogel materials of Maharjan and Brown, with a reasonable expectation of success. One would have been motivated to do so to provide good hydrogel structure as well as good total product structure such as in a layered or scaffolded hydrogel layered product as in Jeong.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0399430A1 (Maharjan et al.; hereafter “Maharjan”) in view of US 2020/0352990A1 (Brown et al.; hereafter “Brown”) as applied to claims 1, 3, 5, 18, 68, and 77 above, and further in view of WO2021/081241A1 (“Lubet”).
The teachings of Maharjan and Brown have been delineated above. Neither of these specifies a monomer as in claim 17.
Lubet cures this deficiency. Lubet teaches temperature-sensitive hydrogels (see Tables 2 and 12 and paragraphs [0150] and [0185] in particular) wherein a poly(N-alkylacrylamide) copolymer of a first monomer (“NIPAM”) and an acrylate component is included (see Example 7, Table 13, and [00195], [0184]). Lubet’s materials may be topically applied. At Table 3B [0190], Lubet teaches “M-254” formulation including NIPAM and acrylic acid components as well as PPG-DA components and comonomer EHA. Lubet’s acrylic acid component meets claim 17’s component 3a.
Maharjan, Brown, and Lubet are all directed to hydrogel materials and their making wherein said hydrogels include NIPAM components. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add an acrylic acid monomer as in Lubet to a NIPAM copolymer in a hydrogel of Maharjan and Brown, with a reasonable expectation of success. One would have been motivated to do so to achieve additional benefit of improved thermal responsiveness from the NIPAM and adhesive strength from the acrylic acid as explicitly taught by Lubet (see [0184]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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