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
The information disclosure statement filed 4/29/24 lists a reference (cite no. 10) that fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of the reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0067], in the section entitled “Description of Reference Signs”, reference 2 (release liner) seems to have been omitted.
Appropriate correction is required.
The use of the terms including Quintac, SIBSTAR, Oppoanol, and DURO-TAK which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware of in the specification
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR20160096155A (cited on the 8/8/24 IDS), further in view of JP11343232A (cited on the 4/29/24 IDS), and even further in view of WO2020175395A1 (cited on the 4/29/24 IDS).
For ease of examination, the Examiner has relied upon US 2022/0142940 A1 as an equivalent English translation of the Japanese WO2020175395 publication. All citations henceforth to WO’395 are locations in the US’940 publication.
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.
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.
Regarding claim 4, JP’232 teaches that the stretch recovery rate (reads on elongation recovery rate) of the entire cover sheet (reads on flow direction and width direction) is 80 to 100% [claim 2]. 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 improve the skin followability of the adhesive patch cover sheet [0014] to ensure skin adhesion [0005]. As the prior art teaches a range that overlaps with the claimed elongation recovery rate of 85% or less, a prima facie case of obviousness exists.
Conclusion
No claims are allowable.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613