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 .
This office action is in response to applicant’s communication of 12/12/2022. Currently claims 17-30 are pending and rejected below.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17-30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2007/002523 A2 (Frederickson).
Frederickson teaches applicator (figure 14-17) for inserting a micro needle array (40) into skin, the applicator comprising: a holding part (132) that holds the micro needle array (40); an insertion assist (138) part that forms an insertion complete state in which a central array region of the micro needle array further protrudes on the skin side than a peripheral array region provided closer to a peripheral side of the micro needle array than the central array region (see figure 15); a first part at which the insertion assist part is provided (138); and a second part (134) at which the holding part is integrally provided at least in a pre- insertion state (figure 14), wherein a relative positional relation between the first part and the second part is changeable (see figures 14-17), and wherein a through-hole is provided at the second part (134), and the insertion assist part is held through the through-hole (see figure 15).
Concerning claim 18 and the insertion assist part (138) forms the pre- insertion state in which the central array region does not further protrude on the skin side than the peripheral array region before the insertion complete state (see figure 14-15).
Concerning claim 19 and receiving force toward the skin, the insertion assist part transitions from the pre-insertion state and forms the insertion complete state (see figure 17 state).
Concerning claim 20 and the holding part is provided on the peripheral array region (note position of 32 part).
Concerning claim 21 and wherein the through-hole includes a large-diameter part (lower portion that 138 goes through) and a small-diameter part (near upper portion of where 138 goes through), the large-diameter part being provided on the micro needle array side, the small-diameter part being provided at a position farther separated from the micro needle array than the large-diameter part, having a smaller diameter than the large-diameter part, and slidably holding the insertion assist part, wherein at least one protrusion is provided at the insertion assist part, and wherein the protrusion passes through the small-diameter part when a magnitude of force toward the skin exceeds a predetermined magnitude (see figures 14-17).
Concerning claim 22 and the through-hole penetrates through the holding part (132), and wherein the insertion assist part further protrudes on the skin side than the holding part in the insertion complete state (see figure 17).
Concerning claim 23 and the holding part (132) is formed such that a central holding region further protrudes on the skin side than a peripheral holding region provided on the peripheral side of the central holding region, and wherein the insertion assist part is formed when the central array region is held in the central holding region (see 40 inside of 132).
Concerning claim 24 and the insertion assist part (138) is formed such that a central assist region further protrudes on the skin side than a periphery assist region provided on the peripheral side of the central assist region (see figure 15).
Concerning claim 25 and the holding part (132) is formed such that a central holding region further protrudes on the skin side than a peripheral holding region provided on the peripheral side of the central holding region, and wherein the insertion assist part is formed when the micro needle array is held in the central holding region and the peripheral holding region (see figure 15).
Concerning claim 26 and the insertion assist part (138) forms the insertion complete state when receiving force along the skin (see figures 15-17).
Concerning claim 27 and the insertion assist part (138) forms the insertion complete state when receiving force that moves closer a pair of facing end parts of the micro needle array (again see figures 15-17).
Concerning claim 28 and a micro needle patch, wherein, in the micro needle patch (30), the micro needle array is bonded to one surface of a bonding tape (38).
Concerning claim 29 and the bonding tape (38) is provided with, in a region in which the insertion assist part contacts a surface (40) to which the micro needle array is not bonded, a recessed part or surface fabrication that increases friction.
Concerning claim 30 and an insertion method of inserting a micro needle array held by an applicator into skin, the insertion method comprising: inserting micro needles into the skin in a state in which a central array region of the micro needle array further protrudes on the skin side than a peripheral array region provided closer to a peripheral side of the micro needle array than the central array region; and removing the micro needle array from the applicator (see figures 15-17 and paragraphs at pages 5-7).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783