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 .
Acknowledgment
Claims 1, 6, 9-10, 12, 15-16, 19 are amended and filed on 5/22/2026.
Claims 2, 17 are canceled.
Claim Objections
Claims 4, 9 are objected to because of the following informalities:
In lines 1-2 of claim 4, “ when the user pulls the tab the corresponding portion” should read as“ when the user pulls the tab, the corresponding portion” ( add comma after tab).
In last 3 lines of claim 9, “ when the user pulls the at least one tab a force removing” should read as“ when the user pulls the at least one tab, a force removing” ( add comma after at least one tab) . Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-16, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gyrn (US. 20110152778A1).
Re claim 1, Gyrn discloses an infusion set configured to facilitate delivery of medicament from an infusion pump to a user (¶0025, ¶0047, Fig. 1-11c, abstract), comprising: an adhesive patch having an adhesive on an underside of the adhesive patch configured to attach the adhesive patch to a body of the user (1, ¶0036) and an opening (7, Fig. 3, Fig. 7, Fig 8, ¶0046, wherein the opening can be located within the periphery of the pad 1 or near the center so that in Fig. 8 can have the opening 7 within 3b portion) extending through the underside of the adhesive patch through which a cannula is configured to be inserted into the body of the user (9, Fig. 10, ¶0046); and a patch liner (liner 3 has at least two sections 3a-b) removably attached to the underside of the patch (¶0036), the patch liner including a continuous spline-shaped liner cut (4 in Fig. 8 the one that separated the 3a and 3b) extending across a diameter of the adhesive patch to divide the patch liner into a first portion and a second portion (¶0037, lines that separate a first portion 3a and a second portion 3b, in Fig. 2-9 see an example of Annotated Fig. 6-8 of Gyrn), wherein the continuous spline-shaped liner cut does not intersect the opening extending through the underside of the patch.(as the opening can be located within the periphery of the mounting pad 1 or near the central part see ¶0038, ¶0046).
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Annotated Fig. 6-8 of Gyrn
Re claim 3, Gyrn discloses wherein the first portion and the second portion of the patch liner each include a tab (6a, 6b) configured to be grasped by the user to pull the corresponding portion off of the adhesive patch, ¶037).
Re claim 4, Gyrn discloses wherein each tab is aligned such that when the user pulls the tab the corresponding portion of the patch liner initially separates from the adhesive patch at a single point on the adhesive patch (Fig. 6-9, ¶0037).
Re claim 5, Gyrn discloses wherein the first portion and the second portion of the patch liner increase in width from the single point around a circumference of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 6, Gyrn discloses wherein each tab is aligned such that when the user pulls the tab a force removing the corresponding portion of the patch liner is directed generally along a circumference of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 7, Gyrn discloses wherein the first portion and second portion of the patch liner each overlap the diameter of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 8, Gyrn discloses wherein at least a portion of each of the first portion and the second portion of the patch liner that overlaps the diameter of the adhesive patch is concentrically aligned with a circumference of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 9, Gyrn discloses an infusion set configured to facilitate delivery of medicament from an infusion pump to a user (¶0025, ¶0047, Fig. 1-11c, abstract ), comprising: an adhesive patch (1, ¶0036) having an adhesive on an underside of the patch (1, ¶0036) configured to attach that adhesive patch to a body of a user ( ¶0046) and an opening (7, Fig. 3, Fig. 7, Fig.9, ¶0046, wherein the opening can be located within the periphery if the pad 1 or near the center so that in Fig. 8 can have the opening 7 within 3b portion) extending through the underside of the adhesive patch through which a cannula is configured to be inserted into the body of the user (9, Fig. 10, ¶0046); and a patch liner (liner 3 has at least two sections 3a-b, ¶0036) removably attached to the underside of the patch, wherein the patch liner include at least one tab configured to be grasped by the user to pull the patch liner off of the adhesive patch (¶0037), and wherein the at least one tab (6a, 6b) is oriented such that when the user pulls the at least one tab a force removing the patch liner from the adhesive patch is directed generally along a circumference of the adhesive patch (¶0037, ¶0047).
Re claim 10, Gyrn discloses wherein the at least one tab I (6a, 6b) s aligned such that when the user pulls the at least one tab the patch liner initially separates from the adhesive patch at a single point on the adhesive patch (¶0047).
Re claim 11, Gyrn discloses wherein the patch liner includes a separate first portion (3a) and second portion (3b, ¶0047), and the at least one tab (6a, 6b) includes a first tab on the first portion (6a) and a second tab on the second portion (6b, ¶0047).
Re claim 12, Gyrn discloses wherein the first portion and the second portion of the patch liner increase in width around a circumference of the adhesive patch (Fig. 7).
Re claim 13, Gyrn discloses wherein the first and second portions are separated by a continuous spline-shaped liner cut extending across a diameter of the adhesive patch (line 4 between 3a and 3b, ¶0047).
Re claim 14, Gyrn discloses wherein the continuous spline-shaped liner cut does not intersect the opening extending through the underside of the adhesive patch (Fig. 7-8, ¶0038).
Re claim 15, Gyrn discloses wherein a body portion of the patch liner connected to the at least one tab overlaps a diameter of the adhesive patch around the circumference of the adhesive patch (Fig. 7-8, ¶0038).
Re claim 16, Gyrn discloses an infusion set configured to facilitate delivery of medicament from an infusion pump to a user (¶0025, ¶0047, Fig. 1-11c, abstract ), comprising: an adhesive patch (1, ¶0036) having an adhesive on an underside of the adhesive patch configured to attach that adhesive patch to a body of the user (1, ¶0036) and an opening (7, Fig. 3, Fig. 7, Fig.9, ¶0046 wherein the opening can be located within the periphery of the pad 1 or near the center) extending through the underside of the adhesive patch through which a cannula is configured to be inserted into the body of the user (9, Fig. 10, ¶0046); and a patch liner (liner 3 has at least two sections 3a-b, ¶0036) removably attached to the underside of the adhesive patch (¶0037), wherein the patch liner is divided into a separate first portion (3a) and second portion (3b), wherein each of the first portion and the second portion overlaps a diameter of the adhesive patch around a circumference of the adhesive patch (Fig. 2-9, ¶0037, ¶0047), wherein at least a portion of each of the first portion and the second portion of the patch liner that overlaps the diameter of the adhesive patch is concentrically aligned with the circumference of the adhesive patch (such as Fig. 8 a portion of 3a close to 6b and a portion of 3b close to 6a, Fig. 2-9).
Re claim 18, Gyrn discloses wherein the first portion and the second portion of the patch liner increase in width around the circumference of the adhesive patch (Fig. 7-8).
Re claim 19, Gyrn discloses wherein the first and second portions are separated by a continuous spline-shaped liner cut extending across a diameter of the adhesive patch (line 4 between 3a and 3d, Fig. 7-8, ¶0038).
Re claim 20, Gyrn discloses wherein the continuous spline-shaped liner cut does not intersect the opening extending through the underside of the adhesive patch (Fig. 7-8, ¶0038, ¶0046 the opening 7 can be on peripheral of the pad 1 or near the center , so that at least Fig. 8 can have a opening 7 not crossed with cut 4 that separated 3a and 3b).
Response to Arguments
Applicant's arguments filed 5/22/2026 have been fully considered but they are not persuasive.
The applicant argues with regards to claim 1 Gyrn fails to show that the continuous spline-shaped liner cut does not cross the opening 7. This is found not persuasive as Fig. 8, and ¶0046 discloses that the opening can be located within the periphery of the pad 1 or near the center so that in Fig. 8 can have the opening 7 within 3b portion as the continuous spline-shaped liner 4 that separate 3a and 3b do not cross the opening if it is located near the center).
The applicant argues with regards to claim 9 Gyrn fails to show that “a tab oriented such that ..the user pulls the tab a force….”. This is found not persuasive this is a functional language, and the tabs 6a and/or 6b are capable to be pulled out (to at least side pull) so that the force is directed generally along a circumference of the patch.
The applicant argues with regards to claim 16 Gyrn fails to show that “at least a portion of each of the first portion and the second portion of the patch liner …. is concentric alignment with the circumference of the patch”. This is found not persuasive as a term “a portion” means that the examiner may applied to any piece (any size) that can meet the limitation such as a piece of 3b near the tab 6a ( Fig. 8, 6c) will be is concentric alignment with the circumference of the patch. (Note: the applicant is advised to amend this claim to structurally define the portion with regards to spline liner cut and the tabs).
Conclusion
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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