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 .
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Applicant’s arguments, filed March 13, 2026, with respect to the non-statutory double patenting rejections have been fully considered, are persuasive and have been withdrawn.
Upon reconsideration, the presently claimed impedance-triggered treatment methodology of the present claims are distinct from the cited co-pending claims.
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) 46-54, 56-67 & 69-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claude et al. (US 2019/0217094) in view of Liss et al. (US 4,586,509).
Claude et al. teaches:
46.
A housing including a treatment electrode and a return electrode
E.G. [0002], [0006] & (Figs. 1-3)
circuitry configured to measure impedance between the treatment electrode and return electrode while the treatment electrode is moved across a facial treatment region.
E.G. [0002], [0039]-[0046].
a detection mode in which impedance is monitored
E.G. [0039]-[0046].
circuitry configured to initiate a treatment mode when the trigger condition is satisfied
E.G. [0040]-[0042]
output of a user indication when treatment mode is entered
E.G. [0028], [0040]-[0042]
delivery of therapeutic microcurrent through the user after the trigger condition is met
E.G. [0041], [0077]-[0078].
Claude et al. teaches impedance-based identification of treatment locations and administration of therapeutic microcurrent to facial treatment regions. However, Claude et al. does not explicitly disclosed a specific current magnitude. Liss et al. teaches facial electrical stimulation utilizing approximately 4mA is effective for transcutaneous stimulation of facial nerve regions to alleviate facial pain [(col. 2, lines 10-27); (col 4, lines 25-30)]. Therefore, it would have been obvious to one having ordinary skill in the art to utilize the stimulation amplitude taught by Liss et al. in Claude’s system in order to provide an effective therapeutic current for facial nerve stimulation because Liss et al. provides a known workable stimulation parameter for the same type of electrical treatment applied to facial tissue. Doing so would merely involve selecting a known stimulation parameter from a finite number of predictable options.
Claims 47-54 are rejected with claim 46
Claude et al. teaches;
47.
dynamically establishing trigger conditions from impedance measurements
E.G. [0039]-[0046].
48.
impedance thresholds based on impedance variables
E.G. [0040]-[0045].
49.
threshold determination using impedance measurements acquired during detection
E.G. [0039]-[0045].
50.
averaging impedance values in determining treatment threshold
E.G. [0041]-[0042]
51.
determining a first derivative of impedance measurements for treatment identification
E.G. [0043]-[0044]
52.
determining a second derivative of impedance measurements
E.G. [0044]-[0045]
53.
identifying treatment regions based on impedance characteristics
E.G. [0043]-[0046]
54.
adaptive treatment initiation based on impedance derived thresholds
E.G. [0039]-[0046].
56.
Claim 56 is rejected for substantially the same reasons set forth for claim 46 because Claude et al. teaches the recited impedance-detection circuitry, trigger-condition establishment, treatment-mode initiation, user indication and therapeutic microcurrent delivery features and Liss et al. teaches the claimed current magnitude.
57-58.
therapeutic microcurrent values less than 300 microamps (e.g., approximately 120 microamps) for treatment stimulation
E.G. [0075]-[0078].
59.
a biphasic waveform comprising alternating current pulses of alternating polarity
E.G. [0075]-[0078].
60-64.
Claims 60-64 recite waveform parameters associated with the biphasic therapeutic microcurrent of claim 59, including waveform frequency, zero DC offset, and pulse duty cycle characteristics. Claude et al. teaches such biphasic stimulations waveforms and associated pulse characteristics [0075]-[0078]. Alternatively, it would have been obvious to one of ordinary skill in the art at the time invention was made to select particular waveform frequencies, duty cycles, etc. for the therapeutic microcurrent taught by Claude et al. because such parameters were recognized in the art as result-effective variables affecting therapeutic efficacy, patient comfort, and stimulation performance. Optimization of known stimulation waveform parameters would have involved only routine experimentation to achieved a desired therapeutic effect. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
65.
applying a stimulation voltage between the treatment electrode and return electrode to generate the therapeutic microcurrent
E.G. [0075]-[0078].
67.
Claim 67 is substantially the same limitation as claim 59 and is rejected for the same reasons set forth above.
69.
Claim 69 is substantially the same limitation as claim 59 and is rejected for the same reasons set forth above.
70.
Claim 70 is substantially the same limitation as claim 57 and is rejected for the same reasons set forth above.
71.
Claim 71 is substantially the same limitation as claim 58 and is rejected for the same reasons set forth above.
Response to Arguments
Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive. The applicant argues the following point(s) in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant’s previous arguments have been considered but are not persuasive for the reasons set forth in the present rejection. Claude et al. teaches the claimed impedance-based triggering and therapeutic microcurrent delivery, while the modifying reference, Liss et al., teaches application of microcurrent therapy to TMJ treatment regions. One of ordinary skill in the art would have been motivated to combine the references to apply Claude’s adaptive triggering techniques to the known TMJ treatment methods of Liss et al. to improve treatment localization and therapeutic effectiveness. Accordingly, the rejection is maintained.
Conclusion
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
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