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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 11/26/25 is acknowledged. Claims 1, 3-10, 12, 23, 24, 27-29, 31, 77, 81, and 82 are withdrawn from consideration.
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) 44, 46, 54, 64, and 65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansoor et al. (US 20200078575).
Regarding claim 44, Mansoor et al. discloses a device (fig. 1-5B) comprising: a substrate 12; and an array of needles 24 disposed on or through the substrate; wherein one or more of the needles is hollow through the entire length of the needle (par. 0060-0066); wherein the array is configured to allow fluid transport through at least one hollow needle of the array (par. 0060-0066); and wherein the array is configured to receive and communicate one or more electrical signals (par. 0064).
Regarding claim 46, Mansoor et al. discloses one or more needles in the array further comprises a coating to penetrate skin to epidermis, dermis, or further beneath the skin (par. 0064, fig. 3A).
Regarding claim 54, Mansoor et al. discloses one or more of the needles is a stimulating electrode (par. 0064, fig. 3A).
Regarding claims 64 and 65, Mansoor et al. discloses a substrate/array configuration that is fully capable of being adjusted for different depths of penetration by a spacer (see structure in fig. 3A). Additionally, Mansoor et al. discloses utilizing a spacer (36; fig. 5A-B) which alters penetration depth of the needles (par. 0078).
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.
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) 47, 49, 50, and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansoor et al. in view of Arias et al. (US 20020133129).
Regarding claims 47, 49, 50, and 55, Mansoor et al. discloses the device as claimed, except for specifically disclosing one or more needles in the array comprise a coating to insulate an electrical signal, one or more needles in the array is coated with an electrically conductive material, one or more needles in the array is at least partially filled with an electrically conductive material, and/or one or more needles is a reference or ground electrode. However, Arias et al. teaches providing insulative coatings on microneedles (par. 0156), conductive coatings on microneedles (par. 0162), filling microneedles with an electrically conductive material (par. 0162), and/or utilizing a reference electrode (par. 0066). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mansoor et al. to utilize any combination of the structures of claims 47, 49, 50, and 55, as taught by Arias et al., since Arias et al. teaches that these structures are all options for fabricating/arranging microneedles in an electrically active array depending on their desired properties.
Claim(s) 64 and 65, in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansoor et al. in view of Hantash et al. (US 20070142885).
Regarding claims 64 and 65, in the alternative to what is disclosed by Mansoor et al. as discussed under 35 U.S.C. 102 above, Hantash et al. teaches utilizing an adjustable spacer 106 to create a desired penetration depth for a needle array (par. 0071; fig. 13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mansoor et al. to utilize an adjustable spacer such as the one taught by Hantash et al. for the purpose of providing sufficient structure for the spacer to enable a variety of possible penetration depths as needed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
O’Brien, III et al. (US 20170354810): energized needle array with spacer
Unger et al. (US 20020099356): layered microneedle construction
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783