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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kato et al. (U.S. Patent Application Publication 2017/0239458). Kato et al., hereafter “Kato,” show that it is known to have a microneedle sheet (Abstract, 0006) comprising a sheet body having a main surface (Figure 1, element 30); one or more microneedles formed in the sheet body, each microneedle having a tip end (Figure 2, element 22), and an X-shaped cut formed in vicinity of the tip end of at least one microneedle among the one or more microneedles (Figure 31C).
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato, in view of Melsheimer (U.S. Patent Application Publication 2011/0034860).
Regarding Claim 2, Kato shows the sheet of claim 1 above, but he does not show states of the sheet being bent. Melsheimer shows a microneedle sheet wherein in a first state in which the sheet body is not bent, the tip end of each of the one or more microneedles is oriented toward one end of the sheet body (0033), and in a second state in which the sheet body is bent, among the one or more microneedles, at least one microneedle positioned at a bent portion of the sheet body is raised from the main surface (0033-0034). It would have been obvious to allow Kato’s sheet to move in the way disclosed by Melsheimer to allow for easy introduction to the therapeutic target and diminish injury (Melsheimer, 0033).
Regarding Claim 3, Kato shows the sheet of claim 2 above, but he does not show states of the sheet between a first state and a second state. Melsheimer shows a microneedle sheet wherein when returning from the second state to the first state, the at least one microneedle having raised and the main surface reduce an angle formed therebetween (0033-0034). It would have been obvious to allow Kato’s sheet to move in the way disclosed by Melsheimer to allow for easy introduction to the therapeutic target and diminish injury (Melsheimer, 0033).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato. Kato shows the sheet of claim 1, including that the size and configuration of the projections can be varied (0107-0121). Kato does not specifically disclose the claimed radius of curvature. However, since radius of curvature is size-dependent, it would have been obvious to one of ordinary skill in the art to choose any appropriate radius of curvature, such as that which is claimed, because where the general conditions of a claim are disclosed by the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05 (II)(A)).
Conclusion
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MONICA ANNE HUSON
Primary Examiner
Art Unit 1742
/MONICA A HUSON/Primary Examiner, Art Unit 1742
