RESPONSE TO AMENDMENT
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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05 November 2025 has been entered.
Application Status
Amendments to claims 1, 2, 10, and 11, filed on 05 November 2025, have been entered in the above-identified application. Claims 1-3, 5, and 9-15 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 November 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
WITHDRAWN REJECTIONS
The 35 U.S.C. § 102 rejection of claims 1, 2, 3, 5, and 13-15 and the 35 U.S.C. § 103 rejection of claims 9 and 11 over Simmons (U.S. Pub. 2019/0167483), made of record on pages 3-7, paragraphs 4-5 of the office action mailed 08 September 2025 has been withdrawn due to Applicant’s amendment in the response filed 05 November 2025. In particular, the adhesive layer of Simmons relied upon for the rejection adheres to another layer and not to a skin layer as presently claimed.
The 35 U.S.C. § 103 rejection of claims 10 and 12 as over Simmons in view of Östan (U.S. Pub. 2017/367898), made of record on page 8, paragraph 6 of the office action mailed 08 September 2025 has been withdrawn due to Applicant’s amendment in the response filed 05 November 2025. Östan does not remedy the above described deficiency of Simmons.
NEW REJECTIONS
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claims 1-3, 5, and 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP H09-135860 A. Applicant’s provided translation of JP ‘860 was relied upon for analysis.
Regarding claim 1, JP ‘860 discloses a skin adhesive sheet having a base layer and an adhesive layer that can adhere to skin, and a release liner having at least two separable pieces that is removably attached to the adhesive layer, see paragraphs [0027-0028] and [0057]. Various configurations of the sheet are shown in FIGS. 3-31. Peeling one separator piece as seen in FIGS. 1-2 exposes a region of the sheet that is adhesive and can adhere to skin while leaving a non-adhesive region (that still covered by the release liner).
The base layer may be square or rectangular as shown in FIGS. 3-31 having a first and second side meeting at a corner. Figure 14 is exemplary of the adhesive sheet having two release liner portions, one portion having a first corner aligned with that of the base layer and having a second, rounded corner. See also discussion at paragraphs [0086-0088] describing the rounded corners.
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JP ‘860 further teaches that the pressure-sensitive adhesive layer that can attach to skin includes additives such as drugs, drug stabilizers, drug absorption enhancers, reducing modifiers to improve adhesive properties or skin irritation. See paragraph [0057]. Including these modifiers in the adhesive provides a side protection zone as claimed.
As shown in FIGS. 1-2, only one section of the separator may be removed, in which case the other separator section is not removed and my contact the skin after adhesion is completed. See paragraphs [0058-0059] regarding removing one section and leaving another section of the separator in place and paragraph [0064] describing the portion in contact with the skin.
The adhesive region necessarily has a higher adhesive strength than the non-adhesive separator portion.
As shown in FIGS. 1-2, the separator region can be pinched and removed with fingers. See also paragraph [0068].
JP ‘860 specifies including additives to reduce skin irritation, see paragraph [0057], and as a result the adhesive patch is hardly uncomfortable, see paragraph [0098].
As a result, JP ‘860 anticipates the claimed invention.
Regarding claim 2, JP ‘860 describes partially applying the adhesive patch to skin surface by removing one section of the separator, see paragraphs [0011] and [0042]. The reference teaches using the adhesive patch to fix an electrode terminal or catheter to the skin, see paragraph [0052], reading on a specific item adhered to the skin as claimed.
Regarding claim 3, as can be seen in the figures such as FIG. 14, the non-adhesive separator portion is located at a position along outer edges of the base layer.
Regarding claim 5, the skin adhesive patches shown in FIGS. 3-31 are rectangular in shape. FIG. 23 depicts a patch with a large separator portion 192A and a smaller one 192B; by removing the larger portion, there would not be a non-adhesive region present in the center region as claimed. FIG. 24 depicts a patch with three separator portions including a central portion which, when removed, results in no non-adhesive region present in the center region as claimed.
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See also discussion at paragraphs [0042-0043] describing the use of larger and smaller portions of the separator to adjust the effective adhesive area of the patch on skin.
Regarding claim 9, JP ‘860 teaches the radius of curvature of R5 (mm) of the adhesive sheets as shown in e.g. FIG. 23-24 above. See paragraphs [0081] and [0083]. The Examiner has interpreted this to mean the radius of curvature is 5 mm.
Regarding claim 10, JP ‘860 shows embodiments with a triangular shaped separator, see FIGS. 3B, 21, 27, 28, and 30. JP ‘860 teaches the radius of curvature of R5 (mm) of the adhesive sheets as shown in e.g. FIG. 23-24 above. See paragraphs [0081] and [0083]. The Examiner has interpreted this to mean the radius of curvature is 5 mm.
JP ‘860 further teaches that the pressure-sensitive adhesive layer that can attach to skin includes additives such as drugs, drug stabilizers, drug absorption enhancers, reducing modifiers to improve adhesive properties or skin irritation. See paragraph [0057]. Including these modifiers in the adhesive provides a side protection zone as claimed for each exposed adhesive portion.
Regarding claim 11, JP ‘860 further shows in FIG. 24 an embodiment with a rectangular adhesive sheet with a rectangular covering having first, second, and third corners and sides. The radius of curvature is 5 mm (R5. See FIG. 24 reproduced above and discussion at paragraphs [0081-0083] regarding the radius of curvature.
JP ‘860 further teaches that the pressure-sensitive adhesive layer that can attach to skin includes additives such as drugs, drug stabilizers, drug absorption enhancers, reducing modifiers to improve adhesive properties or skin irritation. See paragraph [0057]. Including these modifiers in the adhesive provides a side protection zone as claimed for each exposed adhesive portion.
Regarding claim 12, as shown in FIG. 1, removing one portion of the separator layer results in a recessed portion of the adhesive sheet (section B in the figure).
Regarding claim 13, by removing one portion of the separator layer, the adhesive patch has a portion where the adhesive is exposed (that in which a portion of the separator layer has been removed) and another portion where the adhesive is not exposed (that which retains another portion of the separator layer).
Regarding claim 14, the separator layer has dividing lines as shown in the figures, such as dividing liner 31 in FIG. 8. See discussion at paragraph [0065]. These dividing lines permit removal of portions of the separator layer and thus are considered to be cut lines.
Regarding claim 15, a release agent is provided on the separator facing the adhesive layer to permit easy separation. See paragraph [0058].
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant’s arguments in the response filed 05 November 2025 regarding the 35 U.S.C. § 102 and 103 rejection of the claims of record over Simmons (U.S. Pub. 2019/0167483) and other references have been considered but are moot due to the new grounds of rejection.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott R. Walshon whose telephone number is (571)270-5592. The examiner can normally be reached Mon-Fri from 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Scott R. Walshon/ Primary Examiner, Art Unit 1759