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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 8-11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2011/0160654 to Hanson et al. (Hanson) in view of U.S. Patent 6,242,665 to Malowaniec (Malowaniec).
Regarding claim 11, Hanson teaches a medical device (12) comprising a skin-facing surface (22), and adhesive layer (paragraph 115) secured to the skin-facing surface. Hanson does not teach varying adhesive strength areas. Malowaniec teaches an on-body medical device (1) comprising a skin-facing surface (visible side in Fig. 1) and an adhesive layer (2) comprising a stronger adhesive (4) around the periphery and a weaker adhesive (3) within the periphery, wherein the stronger adhesive is as much as 16 (1600%) times as strong as the weaker adhesive (see col. 2, ln. 46-53). Malowaniec teaches that this provides decreased skin stress and pain (col. 2, ln. 6-21). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use stronger peripheral and weaker internal adhesives with the patch of Hanson in order to lessen skin stress and pain in the use thereof. Regarding the intermediate strength adhesive, considering Hanson in light of Malowaniec, it would have been obvious to use a stronger (as taught by Hanson, paragraph 280) adhesive weaker than the perimeter adhesive (4 of Malowaniec) in order to maintain the decreased skin stress and pain of Malowaniec while reinforcing the needle stick itself. The examiner notes that there are three possibilities for the adhesive surrounding the needle site: weaker than both the weaker and the stronger, between them, and greater than the strength of the stronger adhesive. As such, and given that Hanson teaches a stronger adhesive, it would have been obvious to use an intermediate strength as one of a finite set of choices.
Regarding claim 2, Hanson teaches a needle (58) inserted into an opening in the skin of the patient (paragraph 101) and an opening in the adhesive (see Fig. 4) surrounding it.
Regarding claim 8, Hanson teaches a medicament delivery device (12).
Regarding claim 9, Hanson teaches an insulin pump (12).
Regarding claim 10, Hanson teaches a surface (22) on a housing (20).
Regarding claim 11, Malowaniec teaches surrounding holes in the adhesive, as previously discussed. Any of the enumerated elements of claim 11 would be well known in the art and commercially available and the examiner therefore takes Official Notice that a hole in the adhesive therefor would have been obvious at the time of the effective filing date of the application.
Regarding claim 22, Hanson as modified by Malowaniec teaches a stepwise gradient as previously described, wherein the stronger adhesive is as much as 16 (1600%) times as strong as the weaker adhesive (see Malowaniec col. 2, ln. 46-53).
Claim(s) 5-7 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson in view of Malowaniec as applied to claim 1 above, and further in view of CA 2305796 to Webster (Webster, copy attached herewith).
Regarding claims 5-7, the previously applied references teach the invention of claim 1 as discussed above, but do not teach the particular loss profiles of these claims. Webster teaches another type of switchable polymer adhesive for skin, which is light sensitive for causing degradation of the adhesive strength (see page 19, lines 12-27) and decreased trauma to the patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a switchable polymer adhesive as taught by Webster in order to selectively reduce removal trauma to the patient. Thus utilized, the timing of the degradation becomes largely optional and the specific windows of claims 5-7 are effectively only functional limitations on an otherwise identical apparatus.
Regarding claim 21, as above, this limitation is functionally achieved by the switchable nature of the adhesive of Webster. Specifically, a user may peel back part of the occlusive layer and the exposed portion will become the weaker or no adhesive portion of the outer perimeter.
Allowable Subject Matter
Claims 12-20 are allowable over the prior art of record.
The following is a statement of reasons for the indication of allowable subject matter: the limitations of an adhesive layer having multiple islands each with stronger acrylate-based adhesive surrounding a weaker silicone-based adhesive as in claims 12 and 17 are not shown in or fairly suggested by the prior art of record in combination with the remaining limitations of those claims.
Response to Arguments
Applicant’s arguments, see page 7, filed 6 May 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Hanson in view of Malowaniec and Webster.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 20 August 2026
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