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 § 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) 1 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hause et al. (EP 1707236) in view of Takahashi et al. (JP 2007/061483 A).
Regarding claim 1, Hause teaches an integrated transdermal electrical-treatment device comprising positive and negative electrodes, a power source, and respective hydratable matrices containing conductive ionic solutions. The matrices contact the skin to establish an electrical path through the body between the electrodes. See ([0019]-[0020], [0025]-[0029], [0033]-[0035] & [0044]-[0049]). Hause does not expressly disclose the claimed current-density range in these passages.
Takahashi et al. teaches applying weak current through skin using a battery-containing patch and hydrogel-covered electrodes. The “BEST-MODE” section, in the passages addressing energization methods and current density, identifies direct-current operation and a preferred density of 0.002-0.1 mA/cm², equivalent to 2-100 µA/cm². This preferred range falls entirely within the claimed range of at least 0.5 µA/cm² and less than 500 µA/cm². The same section expressly identifies iontophoresis devices operating methods as suitable for providing the treatment.
It would have been obvious, before the effective filing date of the claimed invention, to configure Hause’s patch for direct-current operation within Takahashi’s preferred density range to provide the weak-current skin treatment taught Takahashi. Takahashi expressly identifies iontophoresis equipment as suitable for this purpose, and Hause provides an integrated iontophoretic patch with current-control capability. Applying the disclosed operating parameters to that equipment would predictably deliver weak current through its existing electrode-matrix-skin interface.
Regarding claim 14, Hause teaches applying and operating the patch to pass electrical current through the living body. Operating the modified patch in the direct-current mode and density range discussed for claim 1 provides the claimed method of causing weak current to flow through the body.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hause et al. (EP 1707236) in view of Takahashi et al. (JP 2007/061483 A), as applied to claim 1, and further in view of Barbier et al. (WO 96/22808).
Hause and Takahashi et al. do not expressly establish the recited electrode-area ceiling in the passage relied upon above.
Barbier et al. teaches paired positive and negative adhesive electrode assemblies, each comprising a silver electrode disk having a 20-cm² planar cross-sectional area and contacting a conductive hydrogel. See Example 3 and the accompanying figure, particularly the description of electrode disk 6 and hydrogel 11. Each disclosed electrode therefore satisfies the claimed area of 80 cm² or less.
It would have been obvious to use the disclosed 20-cm² electrode footprint in the modified Hause patch to provide the established hydrogel-coupled contact area used by Barbier for transcutaneous electrical delivery. Both devices employ paired electrodes and conductive matrices for the same current-transfer function. Adopting that known electrode size, with the operating current selected to maintain the density discussed for claim 1, would predictably provide the claimed electrode dimension.
Allowable Subject Matter
Claims 2-11 & 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 2-8: The prior art of record teaches transdermal electrical patches with current regulation, but does not teach or render obvious the respective claimed combinations of patch structure and electrical performance under the specified resistive loads. In particular, the art does not establish the load-dependent current densities of claims 2-5 and 7, the time-dependent output of claim 6, or the energy delivery of claim 8. The identified disclosures do not provide a sufficient factual basis for concluding that these respective operating characteristics would necessarily result or constitute an obvious optimization.
Claims 9-11 and 13: Although the prior art teaches enzyme-bearing electrodes and electrolyte-containing conductive layers, it does not teach or render obvious their combination with the claimed porous sponge arrangement having solid buffer exposed along internal pore surfaces. This structural relationship, considered together with the remaining limitations of claim 9, distinguishes the claimed patch from the identified art. Claims 10, 11 and 13 incorporate this distinguishing combination and further limit the mediator or patch assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nishizawa et al. (JP 2014-207987 A): Discloses a skin-contacting patch having enzyme-bearing electrodes, an electrical connecting member, and electrolyte-containing conductive layers for passing weak current through biological tissue. Particularly pertinent to the enzyme-powered patch features of claims 9-11 and 13. See the patch embodiments and Examples 1 and 3.
Mavor et al. (US 2004/0267189): Discloses an electrically powered dermal patch with conductive fluid retained in porous separators, including sponges, positioned between electrodes and skin. Particularly pertinent to the conductive sponge interface of claim 9. See paragraphs [0034]-[0038].
Huelman et al. (US 2017/0354816): Discloses electrical treatment using current-limiting and feedback circuits that compensate for changes in load resistance, with electrode contact area used to calculate and control current density. Particularly pertinent to the circuit-performance subject matter of claims 2-8.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
