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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1 has a square in the place of the degree symbol in the last line and the square should be replaced with the degree symbol.
Appropriate correction is required.
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.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Rowley (US 2021/0000754) in view of Kawarama et al. (US 2009/0043236).
Regarding claim 1, Rowley discloses a microneedle patch (Figure 1), comprising:
a backing (Figure 1, 110);
an adhesive layer (130) provided on a main surface of the backing (the main surface is the lower surface of 110 that is not visible in figure 1); and
a microneedle array (claim 18 describes microneedles, i.e. a microneedle array in the embossed release liner 120), at least a part of the microneedle array being positioned within the adhesive layer (paragraph 25 describes the adhesive matrix 130 absorbs into the embossed release liner 120), wherein
the adhesive layer comprises a water-soluble polymer (paragraph 28 describes polyacrylic acid, a water-soluble polymer) and water (paragraph 25).
Rowley is silent on a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25 C and a frequency of 1 Hz is 0.20 to 0.41.
Kawarama teaches a loss tangent of the adhesive layer (Table 1) under measurement conditions of an environmental temperature of 25 C (Table 1 shows a wide range of temperatures and a line at 25.12 °C) and a frequency of 1 Hz (paragraph 21 describes the frequency as 6,2832 rad/s, which is 1 Hz) is 0.20 to 0.41 (The table 1 loss tangent value that corresponds to 25.12 °C is 0.294 and the loss tangent value that corresponds to 19.11 °C is 0.337, so the loss tangent at exactly 25 °C would be slightly larger than 0.294 and less than 0.337).
Therefore it would have been obvious to modify Rowley’s invention to include a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25 C and a frequency of 1 Hz is 0.20 to 0.41 in order to provide a gentle enough adhesion to the skin to avoid excessive pain and improved water resistance as suggested and taught by Kawarama in paragraphs 9-11.
Regarding claim 2, Rowley in view of Kawarama teach the invention as claimed and described above. Rowley further teaches wherein the water-soluble polymer comprises at least one of a polyacrylic acid and a partially-neutralized polyacrylate (paragraph 25 describes polyacrylic acid).
Regarding claim 3, Rowley in view of Kawarama teach the invention as claimed and described above. Rowley further teaches wherein the adhesive layer further comprises a polyhydric alcohol (paragraph 27 describes the adhesive layer including glycerin, a polyhydric alcohol).
Regarding claim 4, Rowley in view of Kawarama teach the invention as claimed and described above. Rowley further teaches wherein the polyhydric alcohol is glycerin (paragraph 27 describes the adhesive layer including glycerin).
Regarding claim 5, Rowley in view of Kawarama teach the invention as claimed and described above. Kawarama further teaches wherein the loss tangent is 0.202 to 0.404 (The table 1 loss tangent value that corresponds to 25.12 °C is 0.294 and the loss tangent value that corresponds to 19.11 °C is 0.337, so the loss tangent at exactly 25 °C would be slightly larger than 0.294 and less than 0.337).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katheryn Malatek whose telephone number is (571)272-5689. The examiner can normally be reached Monday - Thursday, 9 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERYN A MALATEK/Primary Examiner, Art Unit 3741
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