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 .
Response to Arguments
Applicant's arguments filed 3/27/2026 have been fully considered.
Regarding claims 1 and 16, Applicant argues that Deck fails to teach the pull tab that is part of the release liner located in the cut-out and freely extending beyond the housing and the cut-out. Applicant points out that Deck discloses that the liner 174 is bent back and returned parallel to itself as can be seen in fig. 3A. The examiner agrees with this characterization of Deck, however, it is clear that when the release liner is not bent back and returned parallel to itself, it will be located in the cut-out and extend freely beyond the housing and the cut-out. Deck states that the liner is bent back, meaning that prior to being bent back, it extends straight away from the housing and extending beyond the housing and the cut-out.
Claim Rejections - 35 USC § 103
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(s) 1-8, 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deck (US 9,872,642).
Regarding claim 1, Deck discloses a patch injection device (col. 1, lines 24-27), comprising: a housing 164 (fig. 3A; col. 20, lines 8-9); an adhesive substrate 166 having a first surface 170 with a first surface area for skin attachment (col. 20, lines 8-14) and a second surface which is opposite the first surface for attaching partly to the housing (col. 20, lines 8-10; fig. 3A); and a removable release liner 174 (fig. 3A; col. 20, lines 18-19), wherein a surface area of the second surface attaching to the housing is smaller than the first surface area and wherein an excess area defines a skirt of the substrate and at least partially surrounds the housing (see fig. 3A annotated below), and wherein the first surface of the substrate attaches to the removable release liner which fully covers the first surface area of the substrate (col. 18, lines 44-47: while this passage describes a different embodiment from the one discussed above, it is understood that the purpose of the release line 172 is the same as the release liner 138, which is to completely cover the adhesive surface), wherein a cut-out of the skirt is adjacent to the housing (see fig. 3A below), wherein a pull tab 174 is part of the release liner and is located in a cut-out of the skirt of the substrate (see fig. 3A annotated below), such that a peel force is transmittable from the release liner to the housing at a location where the cut-out reaches the housing (fig. 3A; col. 20, lines 20-28: the force upon pulling the pull tabs is transmitted to the fold 176 which is at a location where the cutout reaches the housing and therefore this is where the peel force is applied).
Claim 1 calls for the pull tab to be located in the cut-out and freely extend beyond the housing and the cut-out. Deck discloses that the pull tab is bent back away from the cut-out and returned parallel to itself (col. 20, lines 20-25; fig. 1B shows a different embodiment but clearly shows the pull tab bent back). It is clear that when the pull tab is not bent back and returned parallel to itself, it would extend freely beyond the housing and the cut-out. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the pull tab of Deck, prior to being bent back and retuned parallel to itself would be arranged as claimed thereby meeting the claim limitation at the point prior to being bent back.
PNG
media_image1.png
840
1089
media_image1.png
Greyscale
Regarding claim 2, Deck discloses that the pull tabs 174 are folded under themselves at location 176 (col. 20, lines 20-24; fig. 3A). Therefore, should the tabs be extended out to their straight configuration, the release liner would extend partially beyond adhesive substrate in an area of the cut-out, such that a surface area of the release liner is larger than the first surface area.
Regarding claim 3, Deck discloses that the adhesive substrate is flexible (col. 21, lines 58-64: the adhesive substrate is part of the protective component and therefore is also flexible).
Regarding claim 4, Deck discloses that the pull tab is integrally formed with the release liner (col. 20, lines 20-24).
Regarding claim 5, Deck discloses that the pull tab has two branches with an opening therebetween (fig. 3A).
Regarding claim 6, in the device of Deck, when the pull tabs 174 are pulled away from the fold 176, the peel force is transmittable to the housing via the adhesive substrate at the location where the cut-out reaches the housing as the folds are located adjacent to the housing (fig. 3A).
Claim 7 calls for the cut-out to be arc shaped. Applicant has not provided any criticality to this shape by describing that the shape serves any advantage or particular purpose as it is disclosed that the cut-out may have different shapes such as an arc-shape or an elliptical shape or a circular shape (para. 0031). Furthermore, one or ordinary skill in the art would expect Deck’s device and Applicant’s invention to perform equally well with any shape cut-out. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the cut-out of Deck to be arc-shaped because doing so would have been a mere design consideration which fails to patentably distinguish over the prior art of Deck.
Regarding claim 8, Deck shows that the cut-out of the skirt is adjacent to a contacting surface between the housing and the substrate (see fig. 3A annotated above).
Regarding claim 16, Deck discloses a patch injection device (col. 1, lines 24-27), comprising: a housing 164 (fig. 3A; col. 20, lines 8-9); an adhesive substrate 166 having a first surface 170 with a first surface area for skin attachment (col. 20, lines 8-14) and a second surface, which is opposite the first surface for attaching partly to the housing (col. 20, lines 8-10; fig. 3A); and a removable release liner 174 (fig. 3A; col. 20, lines 18-19), wherein a surface area of the second surface attaching to the housing is smaller than the first surface area and wherein an excess area defines a skirt of the substrate and at least partially surrounds the housing (see fig. 3A annotated below), and wherein the first surface of the substrate attaches to the removable release liner which fully covers the first surface area of the substrate (see fig. 3A annotated below), and wherein the first surface of the substrate attaches to the removable release liner which fully covers the first surface area of the substrate (col. 18, lines 44-47: while this passage describes a different embodiment from the one discussed above, it is understood that the purpose of the release line 172 is the same as the release liner 138, which is to completely cover the adhesive surface), wherein a cut-out of the skirt is adjacent to the housing (fig. 3A), wherein a pull tab 174 that is a part of the release liner is located in a cut-out of the skirt of the substrate (fig. 3A: at edge 176) such that a peel force from the pull tab is transmittable to the housing via the adhesive substrate at the location where the cut-out reaches the housing (fig. 3A; col. 20, lines 20-28: the force upon pulling the pull tabs is transmitted to the fold 176 which is at a location where the cutout reaches the housing and therefore this is where the peel force is applied).
Claim 16 calls for the pull tab to be located in the cut-out and freely extend beyond the housing and the cut-out. Deck discloses that the pull tab is bent back away from the cut-out and returned parallel to itself (col. 20, lines 20-25; fig. 1B shows a different embodiment but clearly shows the pull tab bent back). It is clear that when the pull tab is not bent back and returned parallel to itself, it would extend freely beyond the housing and the cut-out. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the pull tab of Deck, prior to being bent back and retuned parallel to itself would be arranged as claimed thereby meeting the claim limitation at the point prior to being bent back.
PNG
media_image1.png
840
1089
media_image1.png
Greyscale
Claim 17 calls the cut-out of the skirt to arc shaped and the arc shaped cut-out is adjacent or congruent to a contacting surface between the housing and the substrate. Deck discloses that the cut-out is adjacent to a contacting surface between the housing and the substrate (fig. 3A), but fails to disclose that the cut-out is arc shaped. Applicant has not provided any criticality to this shape by describing that the shape serves any advantage or particular purpose as it is disclosed that the cut-out may have different shapes such as an arc-shape or an elliptical shape or a circular shape (para. 0031). Furthermore, one or ordinary skill in the art would expect Deck’s device and Applicant’s invention to perform equally well with any shape cut-out. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the cut-out of Deck to be arc-shaped because doing so would have been a mere design consideration which fails to patentably distinguish over the prior art of Deck.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as obvious over Deck in view of Gorman et al (US 2004/0116866).
Claim 18 differs from Deck in calling for the adhesive substrate to comprise a winglet that is not covered by the skin adhesive, whereas a remaining part on the first surface of the substrate is covered with the skin adhesive. Gorman teaches an adhesive substrate for connecting a patch pump to a user’s skin, wherein the adhesive substrate includes a winglet 273 that is not covered by the skin adhesive, whereas the remaining part of the first surface of the substrate is covered with the skin adhesive, the winglet provides an aid in removing the adhesive attachment from the skin when the patient is finished using the device (page 9, para. 0130; fig. 28). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive substrate of Deck to include a winglet that is not covered by the skin adhesive, whereas the remaining part of the first surface is covered with the adhesive as taught by Gorman to provide assistance in removing the device from the skin after use.
Allowable Subject Matter
Claims 9-15, 19, 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: see prior office action.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. 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.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights