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 .
Information Disclosure Statement
Citation 10 on the IDS dated 4/29/2024 has been considered. An updated/signed copy of the IDS dated 4/29/2024 has been placed in the application file.
Response to Amendment
The Applicant's amendments and/or arguments filed 6/12/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant's arguments filed 6/12/2026 have been fully considered. In view of the claims as amended, all rejections presented in the Office Action mailed 3/13/2026 have been withdrawn and new rejections presented below. The arguments in the response filed 6/12/2026 will be addressed below to the extent that they apply to the current rejections.
Regarding Applicant’s assertion of superior results in Table 6, this is not found persuasive. Applicant has not explained why the results are significant and unexpected, nor demonstrated that the results are unexpected compared to the closest prior art.
New 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.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over KR20160096155A (cited on the 8/8/24 IDS), and further in view of JP11343232A (cited on the 4/29/24 IDS), WO2020175395A1 (cited on the 4/29/24 IDS), and KR101436282 (published 8/29/2014).
Regarding claim 1, KR20160096155A teaches an adhesive patch comprising a support layer (reads on backing) [Fig 1 ref 101] and a drug retention layer (reads on drug layer) [Fig 1 ref 102], and a cover material (reads on cover part) [Fig 1 ref 20] comprising a cover layer [Fig 1 ref 201] and a cover adhesive layer [Fig 1 ref 202], wherein the drug retention layer is laminated on one surface of the support layer, the cover material comprising the cover layer and the adhesive layer is laminated on one surface of the cover layer and containing an adhesive material, and the patch and the cover material are arranged such that the adhesive layer is laminated on the other surface of the support layer [claim 1]. KR’155 further teaches that the cover layer may comprise any material capable of supporting and protecting the adhesive layer, including those listed as suitable for use as the support layer [0086], including non-woven fabrics [0054]. KR’155 discloses that adhesive may be a rubber-based adhesive [claim 6].
KR’155 fails to explicitly disclose the elongation rate of the material comprising the cover layer. JP11343232A teaches a cover sheet for a transdermal drug administration patch. JP’232 teaches that the entire cover sheet (reads on flow direction and width direction) may have an elongation rate of 200 to 1500% [claim 1]. JP’232 further teaches that the cover sheet may comprise a non-woven fabric [0010]. It would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of KR’155 with that of JR’232 to select a non-woven fabric material for the cover sheet with an elongation rate taught by JP’232 to impart specific elastic and skin fixation properties [JP’232 0005] to the adhesive patch taught by KR’155. Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
KR’155 fails to explicitly disclose the loss tangent of the rubber-based adhesive. WO’395 teaches a transdermal adhesive patch wherein the adhesive base comprises a styrene-based thermoplastic elastomer (reads on rubber-based adhesive) [claim 1] wherein the adhesive layer has a loss tangent of 0.53 to 0.8 at 1 Hz [claim 4] and 32°C [0058]. It would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of KR’155 with that of WO’395 to formulate a rubber-based adhesive with a loss tangent of 0.53 to 0.8 to obtain an adhesive for use in transdermal patches that maintains adhesion on skin during repeat extension and contraction of joints [0007]. As the prior art teaches a range that overlaps with the claimed loss tangent range of 0.7 to 0.95, a prima facie case of obviousness exists.
KR’155 fails to explicitly an elongation recover rate of 20% to 70% in the flow direction and the width direction. KR101436282 teaches a multi-layer, fiber structure comprising a non-woven web layer [0018-0019], wherein an adhesive may be provided on one side of the multilayered fiber structure [0003; see also 0098]. The invention of KR’282 is suitable for use in bandages [0098] and preferably has a stretch recovery rate of 15% or more [0024]. KR’282 further teaches that if the elongation rate is less than 15% when the multilayered fiber structure is used as an adhesive support, there is a risk that the adhesiveness is insufficient and the fiber structure peels off the skin [0024]. KR’282 discloses that the upper limit of the elongation recovery rate will vary depending on the intended use and site of use of the invention [0024; see also 0002]. For example, the elongation rate may be up to 100% when used in medical sanitary materials [0024]. The instantly claimed range overlaps with the range taught in the prior art and is therefore prima facie obvious. Furthermore, "where 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). The elongation recovery rate is recognized in the prior art as a result-effective variable, thus it would be obvious to a skilled artisan to optimize such a parameter. In the instant case, varying the elongation recovery rate with an expectation of adjusting the adhesive properties, based on the desired use of the non-woven structure, would be obvious. Thus, it would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of KR’155 with that of KR’282 arrive at the instantly claimed elongation recovery rate in order to optimize for desired adhesive properties.
Regarding claims 2 and 3, KR’155 teaches that the rubber-based adhesive may comprise of polyisobutylene or polyisoprene [claim 7]. It would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to select a rubber-based adhesive from adhesives known in the art to be suitable for such purpose.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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