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 1/9/2026. Currently elected claims 6-13 are pending and rejected below.
Election/Restrictions
Applicant’s election without traverse of Group I claims 6-13 in the reply filed on 1/9/2026 is acknowledged.
Claims 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/9/2025. Applicant’s remarks stating that Species D and E (figures 5A and 5B) are the same embodiment is convincing. Therefore those figures will represent Species E.
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) 6-8, and 11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WATANABE et al. (US 2011/0257582 A1).
Watanabe discloses a method comprising: applying a voltage (see para [0019]) differential to a first electrode of a medicament delivery device and a second electrode (electodes 2 and 3) of the medicament delivery device to generate an electric field, and flowing medicament (A) from a reservoir (interior of 1) to an array of microneedles (4) arranged on the skin, wherein the electric field increases the flow of medicament (see para [0036])..
Concerning claim 7 and ionizing molecules of air present between the first and second electrode using the electric field, and flowing the ionized molecules of air towards skin of a patient using the electric field such that a permeability of the skin is increased (see paras [0008], [0011], and [0038]).
Concerning claim 8 and applying the voltage differential to the first electrode of the medicament delivery device and the second electrode of the medicament delivery device to generate the electric field comprises applying a pulse to the voltage differential to generate a pulsing electric field (see para [0038]).
Concerning claim 11 and the second electrode is permeable (see para [0041] discussing holes, slits or the like formed through the electrode plates.).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WATANABE et al. (US 2011/0257582 A1).
Concerning claim 9, Watanabe discloses the claimed invention except for explicitly stating that the pulsing is for at least one second. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the pulsing is for at least one second, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). It is examiner’s position that a PHOSITA would look to various timings for the duration of the pulse. A plus of at least one second would allow the medicament to flow via electrical stimulation while providing a break in duration for cooling or intermittent delivery.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WATANABE et al. (US 2011/0257582 A1).
Watanabe discloses the claimed invention except for explicitly stating that the voltage differential is about 50 volts. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have that the voltage differential is about 50 volts, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). It is examiner’s position that a PHOSITA would have the voltage differential is about 50 volts as iontophoresis machines typically may use voltage from 10 to 54V in order to drive ionized medication or water effectively through the skin. Voltage of about 50 would be required depending on the type of medicament driven and the thickness of the skin barrier.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over WATANABE et al. (US 2011/0257582 A1) in view of SMITH. (WO 2010/030738 A2).
Concerning claim 12-13, Watanabe discloses the claimed invention except for the step of providing the ventilation comprises operating a fan. Smith teaches that it is known to use the step of providing the ventilation comprises operating a fan as set forth in paragraphs at page 48 lines 14-29 to provide a means to maintain proper moisture or drying of the composition from the porous substrate.. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Watanabe with the step of providing the ventilation comprises operating a fan as taught by Smtih since such a modification would provide the method with the step of providing the ventilation comprises operating a fan for providing a means to maintain proper moisture or drying of the composition from the porous substrate.
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