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 Argument and Amendment
The response filed on 2/2/26 has been entered.
Applicant’s arguments filed 2/22/26 have been fully considered but they are not deemed to be persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 7-9 and 19-22 are pending in this office action.
The rejection of claims 1-3 under 35 U.S.C. 112, second paragraph, as being indefinite is withdrawn due to the amendment of the claims.
Claims 1-2 rejected under 35 U.S.C. 102(b) as being anticipated by Zhang et al. (WO 2007/070643) is withdrawn based on the argument and the amendment submitted found persuasive..
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) !-3, 7-9 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (WO 2007/070643) in view of Quinlan et al. (WO 2017/108215) and Othel-Jacobsen (US 2022/0339349) and further in view of O’Connor et al. (US 2002/0185184).
With regards to instant claims 1,nand 19, Zhang teaches an adhesive layer for the skin (i.e., a patch as interpreted , see pg 1, lines 9+, see pg 14, lines 11+) that is flexible (see pg 14, lines 29+) with a therapeutic agent i.e., a corticosteroid (see pg. 6, lines 19+, as required by instant claims 1-2) when applied to the skin (see abstract).
However, fails to teach that the adhesive patch composition is comprises an adhesive patch in a selective pattern, and fails to teach a second flexible layer of material and a medical device.
With regards to instant claim 1, Quinlan teaches an adhesive patch (see para 0004) comprising a flexible adhesive layer that can be adhered to the skin (see para 0004) and a second layer (see 0073, as required by instant claim 4) adaptable to a health device (see abstract). With regards to the second flexible layer adapted to adhere to the first layer material, as they comprise the same material and therefore adaptable to adhere to the first layer (see 0073, as required by instant claim 5) to a medical device a health device (see 0005, 0007, as required by claim 5-6) wherein the health device is a glucose monitor (see 0049, as required by instant claim 7). Therefore it would have been obvious to one of ordinary skill in the art to include in the teaching of Zhang to include a medical device as taught by Quinlan because Quinlan teaches an adhesive patch that has a medical device.
Banyal teaches a transdermal drug delivery system containing a discrete dosage form as medicated adhesive for the skin wherein the adhesive is a multi-layer drug in adhesive (as required by instant claim 8, wherein the drug is disposed between the backing and the liner (see diagram , pg 115) and therefore the drug will diffuse through the adhesive composition (as required by instant claim 9).
Othel-Jacobsen teach with regards to instant claims 1 and 19 a patch (see tittle) comprising a first and second layer (see abstract) configured to adhere to the skin (see abstract) and configured to adhere to a medical device (see 0021) wherein the adhesive layers may be replaced with microneedles 9see 0057) wherein the begins to release into patient skin upon application of the patch and may comprise anti-inflammatory agent (see 0057, as required by instant claims 1-2).
O’Connor teaches an adhesive tape (see 0047), comprising a microfluidic path (see 0043), see
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and would therefore would dispose the therapeutic in a selective pattern.
It would have been obvious to one of ordinary skill in the art to adhere one of the layers to the medical device and the skin.
It would have been obvious to one of ordinary skill in the art to expand the teachings of Zhang to include Quinlan, Banyal, Othel-Jacobsen and O’Connor to result in the instant claimed invention with a reasonable expectation of success because they are drawn to the same technical feature.
Applicant’s argument have been considered and the response is moot based on the new rejection above.
No claims are allowed.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 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, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 3/17/26
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