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 .
Application Status
Claim 16 has been added in the amendment filed 18 May 2026. Claims 1-3, 5, and 9-16 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04 March 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
NEW AND REPEATED 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 9-16 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(a) 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].
Regarding claim 16, Among the various examples of the separator layer arrangements shown in the figures of JP ‘860, FIG. 14(b) depicts an arrangement in which the second corner is rounded continuously from the first side of the covering without creating a pointed or sharp portion. FIG. 17 also shows a sinusoidal interface between the separator sections as shown below which also does not create a pointed or sharp pattern.
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FIG. 14(b) FIG. 17
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant’s arguments in the response filed 18 May 2026 regarding the 35 U.S.C. § 102 rejection of claims 1-3, 5, and 9-15 of record over JP H09-135860 A have been carefully considered but are deemed unpersuasive.
Applicant argues on p. 9 of the remarks that JP ‘860 is structurally and functionally distinct from the claimed invention. In particular, applicant notes that JP ‘860 discloses a sheet having a two-part release paper structure in which one of the split release papers is first peeled off to temporarily attach the sheet to skin, after which the remaining release paper is peeled off so that the entire surface of the sheet is adhered to the skin. Applicant argues that the sheet of the invention does not require peeling off the covering paper in this manner. In other words, JP ‘860 allegedly does not disclose the post-removal structure of claim 1.
The Examiner is not persuaded. The manner of separation of the release liners when used to contact the skin is concerned with the method of using the claimed skin adhesive sheet. However, the claims are directed to the skin adhesive sheet structure having the functional limitations as specified. The adhesive sheets of JP ‘860 are capable of meeting the claimed structural and functional limitations as noted in the rejection above. In particular, there is no requirement that both portions of the release liner be removed in order to contact the skin. Instead, claim 1 specifies that “…the release liner is removable to expose the adhesive so that the base layer can be adhered to the skin with the exposed adhesive while having the non-adhesive region”. The structure of the adhesive sheets of JP ‘860 meets this condition.
Applicant argues that claim 1 distinguishes from the “release liner” and the “covering” that forms the non-adhesive region, while JP ‘860 discloses that the separator pieces are used for staged exposure of the adhesive layer during application. However, JP ‘860 reads on such a structure as one portion of the release liner may be the claimed “release liner” and another portion may be the “covering”, as one such portion can be removed and another such portion can be left on the adhesive.
Applicant also argues that JP ‘860 does not disclose the claimed side protection zone, and points to the specification which describes this as an adhesive-region feature.
The Examiner is not persuaded. The claims require that the side protection zone is included in the adhesive region between the covering second corner and the first side of the base layer. JP ‘860 includes additives in the adhesive for reducing skin irritation, and as such these additives provide for a side protection zone as claimed.
Regarding new claim 16, applicant argues that JP ‘860 does not disclose that the covering second corner is rounded continuously from the first side of the covering without creating a pointed or sharp portion. However, JP ‘860 depicts many examples of suitable release liner portions including those in FIGS. 14(a), 14(b), and 17 as depicted above, each of which shows arrangements which allow for one portion to be moved such that no sharp corners remain.
Accordingly, this 35 U.S.C. § 102 rejection is maintained.
Conclusion
All claims are rejected.
THIS ACTION IS MADE FINAL. 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 extension fee 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 Scott R. Walshon whose telephone number is (571)270-5592. The examiner can normally be reached Mon-Fri from 9am - 6pm.
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, 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
Prosecution Insights