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 .
Priority
The instant application is a Continuation of PCT/US2021/072505 filed 19 November 2021. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US application 63/117,112 filed 23 November 2020.
Examiner's Note
Applicant's amendments and arguments filed 12 January 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 12 January 2026, it is noted that claims 1, 9, and 13 have been amended and no new matter or claims have been added. Support can be found in the specification at [0044].
Status of the Claims
Claims 1-20 are pending.
Claims 13-20 are withdrawn.
Claims 1-12 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. (US 2021/0345995) in view of Foreman et al. (US 2003/0022980).
Dobak teaches non-invasive adhesive patches for collecting cell samples [0002]. The patch comprises a sample collector and an adhesive patch [0040]. The collection area (layer) can be a polyurethane carrier film while the adhesive matrix can be comprised of a synthetic rubber compound and can be a pressure sensitive adhesive [0063-0064]. The rubber can be a mixture of acrylics and rubbers comprising a hydrophobicity (moisture vapor transmission rate - MVTR) ranging from 2000 g/m2/24 hours or less, with “no more than 400” g/m2/24 hours as a preferred embodiment [0064]. The adhesive material can be flexible [0075]. The composition can comprise a backing layer, which also comprises polyurethane, and which is no more than 7 mils (177 mm) thick [0069, 0074]. The patch, as a whole, has a thickness such that it does not self-adhere when supported by the non-adhesive layer [0067] and can be sized larger than the desired collection area [0003]. Moreover, the composition can comprise a peelable release sheet or removable liner [0077, 0080].
Dobak does not teach the adhesive matrix is prepared with acrylic polymers copolymerized with rubber polymers.
Foreman teaches pressure sensitive adhesive formulations comprising acrylic polymer grafted with hydrogenated rubber (abstract). The adhesives can be used on articles such as tapes and transfer films [0009]. The adhesive formulations provide an exceptional combination of adhesion to low energy surfaces and high temperature cohesive strength (abstract) [0005]. The pressure-sensitive adhesive can comprise an acrylic polymer grafted with a rubber macromer such as ethylene-butylene [0006] wherein the acrylic acid can be used in about 7 wt% [0016] and the rubber can be formed from 1,3-butadiene or isoprene [0021]. The adhesive can further comprise excipients, plasticizers, and antioxidants [0027].
It would have been prima facie obvious to prepare the medical patch of Dobak comprising a polyurethane carrier layer and an adhesive layer, wherein the composition further comprises a release liner. The adhesive is not particularly limited in Dobak, except for the requirement that the moisture vapor transmission rate be preferably no more than 400 g/m2/24 hours. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of layers including a polyurethane layer, adhesive layer, and release liner from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
The skilled artisan would have been motivated to look to Foreman, which teaches an adhesive layer useful in tapes and films that has improved adhesion to low energy surfaces. The adhesive composition of Foreman can comprise a copolymer of acrylic acid monomers and rubber formed from isoprene. The modified patch of Dobak would accordingly comprise a polyurethane layer and an adhesive layer of Foreman, thus rendering obvious instant claims 1, 3-6, and 8. Regarding instant claim 2, Dobak teaches the polyurethane-containing backing layer is no more than 177 mm thick and further teaches that the patch can be sized larger than the desired collection area but does not teach a suitable weight of the polyurethane backing layer or collection layer. That being said and in lieu of objective evidence of unexpected results, the weight of polyurethane layer can be viewed as a variable which achieves the recognized result of successfully preparing a patch with a suitably sized backing layer and collection layer. The optimum or workable range of polyurethane can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). Claims 1-6 and 8 are accordingly rejected as obvious over the prior art.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. (US 2021/0345995) in view of Foreman et al. (US 2003/0022980) in view of Yie et al. (US 2009/0196910).
Dobak and Foreman, as applied supra, are herein applied in their entireties for the teaching of a patch composition comprising a polyurethane layer, an adhesive layer, and a release liner.
Dobak does not teach wherein the release liner is a siliconized released paper.
Yie teaches transdermal patches comprising a peelable release liner wherein the release liner is to be peeled off before use [0031]. The release liner can be made of siliconized polyester films [0031].
It would have been prima facie obvious to prepare the patch composition of Dobak and Foreman, which comprises a release liner, and make said release liner using siliconized polyester films as required in instant claim 7. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07). Claims 1-8 are accordingly rejected as obvious over the prior art.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. (US 2021/0345995) in view of Foreman et al. (US 2003/0022980) in view of Yie et al. (US 2009/0196910) in view of Toth et al. (WO 2016/019250).
Dobak, Foreman, and Yie, as applied supra, are herein applied in their entireties for the teaching of a patch composition comprising a polyurethane layer, an adhesive layer, and a release liner.
Dobak does not teach a device comprising an adhesive matrix, polyurethane layer, second adhesive, and a detector.
Toth teaches systems, devices, and kits for monitoring one or more physiologic signals from a subject including in the form of patches (abstract). Toth teaches that it is advantageous to work towards minimization of size and weight of the patch [00194]. The patch may include an adhesive layer comprising a biocompatible pressure sensitive adhesive [00245]. The patch may further comprise one or more photodetectors configured to determine signals such as hydration of the tissue contained therein [00414].
It would have been prima facie obvious to prepare the patch composition of Dobak, Foreman, and Yie and further include it in the device of Toth. The resulting device would comprise a patch comprising at least one adhesive layer of Dobak and Foreman, a flexible polyurethane layer, and a detector. Including a second adhesive would have been obvious since Dobak teaches combinations of adhesives can be used. The detector of Toth would have been obvious to include due to the benefit of being able to monitor physiologic signs from a subject such as tissue hydration (a biochemical change). The resulting device renders obvious instant claims 9-12 in addition to previously rejected claims 1-8.
Response to Arguments
Applicant's arguments filed 12 January 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 6-7 of their remarks, that Dobak teaches a MVTR of no more than 150 g/m2/24 hours and that there is no teaching for a skilled artisan to increase it to 300-400 g/m2/24 hours.
In response, the Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). Dobak more broadly teaches a hydrophobicity (moisture vapor transmission rate - MVTR) ranging from 2000 g/m2/24 hours or less, with “no more than 400” g/m2/24 hours as a preferred embodiment. As such, a moisture vapor transmission rate of 300 to less than 400 g/m2/24 hours would have been obvious based on Dobak as it falls within the range taught in the prior art.
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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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