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 5/21/2026. Currently elected claims 6-13 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) 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 the amended claim language of from a power supply examiner is of the position that the electrodes apply voltage from a source of power or power supply. Further see Watanabe at para [0037-0039] for example of power supply. Further examiner is of the position that the interior of 1 would be considered a reservoir as it holds internal components within such as plates and substance agent “A” as shown in figure 1. Further this substance “A” flows from the interior of A to the needles 4 arranged on the skin as in figure 1-7.)
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.
Response to Arguments
Applicant's arguments filed 5/21/2026 have been fully considered but they are not persuasive. Examiner argue that the prior art fails to show a “reservoir”, which “flow from the reservoir to the microneedles”, and further a “power supply”. Examiner disagrees.
As explained in the rejection above, concerning the amended claim language of from a power supply examiner is of the position that the electrodes apply voltage from a source of power or power supply. Further see Watanabe at para [0037-0039] for example of power supply. Examiner is of the position that the interior of 1 would be considered a reservoir as it holds internal components within such as plates and substance agent “A” as shown in figure 1. Examiner is of the position that even if described as a “cloth” it satisfies the broadest reasonable definition of a “reservoir”. Further this substance “A” flows from the interior of A to the needles 4 arranged on the skin as in figure 1-7.
Applicant is recommended to amend the claims to greater define structures to overcome the prior art of record and any obvious modifications thereof.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
Prosecution Insights