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 Status
Claims 14 and 17 are cancelled.
Claims 1-13, 15 and 16 are pending. Applicant’s IDS has necessitated a new ground of rejection. Accordingly, this Action is FINAL.
Priority
The Examiner acknowledges the certified translation of the foreign priority document.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/3/26 was filed after the mailing date of the non-FINAL Office Action on 9/3/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's Declaration under 37 CFR 1.132 by Dr. Klaus Hinkelmann, amendments and arguments filed 2/3/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-17 were rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement; Claims 1-17 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement; and claims 1-17 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s Declaration, amendments and arguments are persuasive.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Allowable Subject Matter
Claims 1-13 appear free of the art pending a search update at the time of allowance. The following is a statement of reasons for the indication of allowable subject matter: It appears to be a novel concept to employ a non-UV curable acrylate adhesive on the patch and have activation of the patch by repeated irradiation of the underside with UV light either before or after application of the adhesive.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over MOSKINTO 2018 (IDS filed 2/3/26 NPL reference #4) and Copeland (US3121021; IDS filed 2/3/26).
Applicant claims:
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Considering objective evidence present in the application indicating obviousness or nonobviousness
The specification teaches that the irradiation modifies the adhesive in “a beneficial way, which also has a positive effect on the mechanical properties of the patch” (Page 5, line 33 through page 6, line 2). The specification also teaches that: “Irradiation with different wavelengths results in different penetration depths, which leads to different mechanical stress patterns at these depths” (Page 6, lines 5-8); “ the mechanical properties of the patch, as well as the "composite system" of patch and skin, are optimally improved.” (Page 6, lines 9-12); and “the manufacturing process according to the invention improves the mechanical properties of the patch” (Page 6, lines 31-32). However, actual testing to confirm the alleged improved mechanical properties, such as a side by side comparison with MOSKINTO, which appears to be the closest prior art, has not been done. There appears to be no evidence of any improvement in this record at this time.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a topical patch research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from transdermal drug delivery systems, wearables, or medical adhesives, which requires a multidisciplinary knowledge base spanning materials science, chemistry, biomedical engineering, and dermatological safety. The topical patch artisan combines expertise in polymer chemistry to design sticky, biocompatible materials with clinical knowledge of how these adhesives perform over time on human skin.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 15-16, MOSKINTO teaches a lattice shape, grid structure that is tailored to a size suitable for covering an area from which itching and swelling originates (see figure), skin pad that is the salvation for insect bite itching. The product is free of drugs and prevents itching and swelling subsides, is made of polyester and polyurethane and has a skin friendly acrylate adhesive.
Regarding claim 15, Copeland teaches breathable surgical adhesive tape with an adhesive that is non-irritating to the human skin (Abstract; Column 1, lines 15-24) and that coatable acrylic adhesives are in a solvent mixture of isopropanol (isopropyl alcohol), heptane and ethyl acetate (Column 5, lines 44-52; column 8, lines 9-12). The acrylate adhesive is not UV-cured but rather dried in an oven (Column 6, lines 5-10). Thus, solvent borne polyacrylate solutions are well-known in the art.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and MOSKINTO is that MOSKINTO do not expressly teach employing a non-UV curable acrylate adhesive in a solvent selected from isopropanol, heptane and ethyl acetate. This deficiency in MOSKINTO is cured by the teachings of Copeland.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a non-UV curable acrylate adhesive in a solvent selected from isopropanol, heptane and ethyl acetate, as suggested by Copeland, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. MOSKINTO teaches a skin friendly acrylate adhesive and Copeland guide the artisan to non-UV curable acrylate adhesives that are non-irritating to the human skin and are in the solvents of isopropanol, heptane and ethyl acetate. Consequently, it would be obvious to use the non-skin irritating heat curable non-skin irritating acrylate adhesives in isopropanol, heptane and/or ethyl acetate solvent of Copeland in the insect bite lattice shaped plaster of MOSKINTO with a reasonable expectation of success. In an alternative interpretation, the ordinary artisan in this art would be aware of UV-curable acrylate adhesives and non-UV-curable acrylate adhesives and it would merely be judicious selection of one adhesive over the other with a reasonable expectation of success. As the Supreme Court explained in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), "when 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." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). Furthermore, "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982). The instant specification does not appear to provide any objective evidence of significant improvement(s) from the use of non-UV-curable acrylate adhesive over the prior art acrylate adhesive system.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
Claims 15-16 are rejected.
Claims 1-13 are allowed pending a search update at the time of allowance. Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 2/3/26 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613