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 .
Response to Arguments
Applicant's arguments filed 2/2/2026 have been fully considered but they are not persuasive.
Applicant argues “None of Hyde, Siff, nor Ochs describe such a probe, nor indeed are they cited for such. However, Francis also does not describe such a probe, although paragraphs [0037]- [0038] are cited in support of such. These paragraphs describe conically shaped microneedles of various diameters. However, nowhere does Francis describe tri-tip microneedles. Francis depicts long rows of microneedles, but no tri-tip probes.”
The examiner is maintaining the rejection for two reasons.
1) The examiner believes Francis reads on the tri-tip limitation. [0032] states “the microneedle array includes any number of microneedles”, which would encompass 3 microneedles. MPEP 2144.05(I) states that “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. As such the prior art’s range for the number of microneedles in Francis would overlap with having three microneedles. Even if more microneedles were used, they could be interpreted as discrete 3 microneedle “probes”. For example, 12 microneedles could be interpreted as 4 tri-tip probes. The applicant claims no structure with the probes to avoid this interpretation. Note that the microneedles of Francis penetrate to the same depth as claimed (e.g. see [0037]-[0038] of Francis).
2) The tri-tip probe claimed lacks criticality in the applicant’s specification. [0009] and [0028] of the applicant’s printed publication (Pub. No.: US 2025/0319310 A1) are the only places where the tri-tip probe is mentioned. [0028] discloses “[0028] The probes 120 make direct electrical contact with the patient, as generally described herein, and include at least one ground probe 206 and at least one signal probe. In various embodiments, the probe tips 120 include at least one of barbs, spring-barbs, tridents, tri-tips, and tri-tips with a ground, with each probe 120 sharpened so as to penetrate or make contact with the patient's skin as described herein. In some embodiments the probe 120 tips penetrate the epidermis and extend to the interface between the epidermis and the dermis, generally in the vicinity of the papillary and reticular layers. However, other depths of probe 120 penetration are also contemplated.” Thus, it seems to the examiner that the tri-tip is one of multiple configurations. The specification doesn’t disclose any criticality as to why the tri-tip probe must be used or what advantages it provides. Further, the number of microneedles is an art-recognized result-effective variable since Francis states “the microneedle array includes any number of microneedles as discussed above. The alternate configurations disclosed in [0028] further reinforce the lack of criticality for a tri-tip probe.
For the reasons mentioned above, the examiner is maintaining the rejection and making this action final.
Claim Rejections - 35 USC § 103
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 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) 1-4, 6-8, 10-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (Pub. No.: US 2017/0027812 A1); hereinafter referred to as “Hyde”, in view of Siff et al. (Pub. No.: US 2024/0252819 A1); hereinafter referred to as “Siff” and Francis et al (Pub. No.: US 2015/0141910 A1); hereinafter referred to as “Francis”.
Regarding claim 1, Hyde discloses a nerve stimulation device (e.g. see figure 13 element 1300), comprising: a processor (e.g. see [0149], “computation-based system (including, e.g. an artificial intelligence)”) adapted to receive input parameters pertaining to physiological conditions of a patient, and to processes the input parameters using AI to specify output parameters of a signal (e.g. see [0149], “Recommendation 1372 may relate to a configuration of neural stimulus control signal 1319 or secondary stimulus control signal 1346”), a waveform generator (e.g. see figure 13 element 1308) adapted to receive the output parameters and to create the signal having the output parameters, an output (e.g. see figure 13 element 1312) adapted to receive the signal, a lead (e.g. see figure 4A elements 408/410/412) adapted to receive the signal from the output, and a probe (e.g. see figure 4A elements 414a and 414b) adapted to receive the signal from the lead and to deliver the signal to a nerve of the patient.
Hyde discloses the claimed invention but is silent as to an amplifier adapted to receive the signal and to amplify it to a desired level. Siff teaches that it is known to use such a modification as set forth in [0006], [0058]-[0060], [0063]-[0074] to provide a wider range of voltages, better efficiency, and minimal heat generation (e.g. see [0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use amplifiers as taught by Siff in the system/method of Hyde, since said modification would provide the predictable results of a wider range of voltages, better efficiency, and minimal heat generation.
Hyde and Siff disclose the claimed invention for the probe is a tri-tip probe that pierces the patient’s epidermis and delivers the signal at an interface between the patient’s epidermis and dermis. Francis teaches it is known to use such a modification as set forth in [0037]-[0038] to allow penetration into the upper epidermis, as far as the deep epidermis or even the upper dermis, but not allowing penetration deep enough into the skin to cause bleeding (e.g. see [0037]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to pierce the epidermis with at least 3 skin piercing electrodes as taught by Francis in the system/method of Hyde and Siff, since said modification would provide the predictable results of allowing penetration into the upper epidermis, as far as the deep epidermis or even the upper dermis, but not allowing penetration deep enough into the skin to cause bleeding.
Regarding claims 2 and 12, Hyde discloses the physiological conditions include at least one of temperature, heart rate, HRV, blood pressure, electrical impulses of the patient’s nervous system, blood oxygenation, hydration, and brain activity (e.g. see figure 7 elements 702, 750, 758, 780).
Regarding claims 3 and 13, Hyde discloses sensors for measuring the physiological conditions (e.g. see figure 7 elements 702, 750, 758, 780).
Regarding claims 4 and 14, Hyde discloses a radio for receiving at least one of the physiological conditions, power for the device, and operating instructions (e.g. see figures 7 and 10, element 848).
Regarding claims 6 and 15, Hyde discloses the lead comprises multiple leads and the signal is applied to each of the multiple leads (e.g. see figure 5 elements 504a and 504b).
Regarding claims 7 and 16, Hyde discloses the lead comprises multiple leads and a different signal is applied to each of the multiple leads (e.g. see figure 5 elements 504a and 504b).
Regarding claims 8 and 17, Hyde discloses the output parameters include at least one of location of signal delivery, signal intensity, signal waveform shape, signal frequency, signal cadence, signal duration, and signal amplitude (e.g. see figure 13 elements 1326-1333).
Regarding claims 10 and 19, Hyde discloses the probe delivers the signal to at least one of the patient’s auriculotemporal nerve, trigeminal nerve, and vagal nerve (e.g. see [0087], [0106], [0127])
Regarding claim 11, Hyde discloses the invention (see the rejection for claim 1 above) and discloses the signal providing neuromodulation to the nerve (e.g. see figure 13 element 1303) and discloses reducing the pain in the patient (e.g. see [0104], [0128], [0138]).
Regarding claim 20, Hyde discloses 20. The method of claim 11, wherein the pain includes pain from at least one of post operative shoulder surgery, post operative knee surgery, post operative cardiovascular surgery, post operative caesarian section surgery, drug detox, migraine headaches, pediatric irritable bowel, and diabetic neuropathy (e.g. see [0104], [0128], [0138]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyde and Siff, in view of Ochs et al. (Patent No.: US 10,143,833 B1); hereinafter referred to as “Ochs”.
Regarding claim 5, Hyde and Siff disclose the claimed invention except for the lead comprises a signal lead and a ground lead. Ochs teaches that it is known to use such a modification as set forth in figure 4 elements 601a, 601b, 601c, column 7 line 34 through column 8 line 12 to provide a custom pain treatment region. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such a modification as taught by Ochs in the system/method of Hyde and Siff, since said modification would provide the predictable results of a custom pain treatment region.
Conclusion
THIS ACTION IS MADE FINAL. 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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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