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 Amendment
Applicant’s amendment dated June 26, 2026 is acknowledged. Currently claims 15-21 and 35-42 are pending in this application.
Response to Arguments
Applicant's arguments filed June 24, 2026 have been fully considered but they are not persuasive.
Applicant argues that because Hershey discloses stimulation at a significantly higher frequency than the instant application, that it teaches away from Applicant’s invention. Examiner disagrees. Hershey is not relied upon for teaches of specific stimulation frequencies. As shown below, Tai discloses that desired frequencies. Hershey is relied upon solely to teach a feedback system for adjusting stimulation parameters, which is applicable across stimulators of all frequencies. It would have been obvious to one having ordinary skill in the art to include the biomedical sensor and feedback system of Hershey in the device of Tai since such a modification would provide the system the ability to provide the best treatment parameters based on feedback.
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.
Claims 15-18, 36-37, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Tai (US 2013/0006322, as previously cited) in view of Hershey (US 2015/005852).
Regarding claim 15 and 37, Tai discloses a wearable device for dual transcutaneous stimulation of a first peripheral nerve and a second peripheral nerve for treating inflammatory (e.g. two channel system; [0042] treatment of inflammatory gastrointestinal disorders; [0024]);
a controller (e.g. controller 30 as shown in Figure 1);
a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the first peripheral nerve (e.g. electrode 14 as shown in Figure 1);
a second peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the second peripheral nerve (e.g. electrode 15 as shown in Figure 1); and
deliver the first electrical stimulus to the first peripheral nerve through the first peripheral nerve effector and deliver the second electrical stimulus to the second peripheral nerve through the second peripheral nerve effector to reduce inflammatory disease symptoms based on the feedback information (e.g. delivery of stimulation via electrode 1 and 2 as shown in Figure 3),
providing feedback information (e.g. feedback and adjustment capability of the system as described in [0042]),
wherein the controller comprises a processor and a memory for receiving the feedback information from the sensor that, when executed by the processor, cause the device to: adjust one or more parameters of a first electrical stimulus and a second electrical stimulus based at least in part on the feedback information (e.g. adjustment capability of the system as described in [0042]),
wherein the device is not configured for implantation within the patient (e.g. as shown in Figure 3; Title); and
wherein the first electrical stimulus and the second electrical stimulus each have a frequency between 1 Hz and 100 Hz (e.g. stimulation using two channel system as described in [0042] wherein stimulation is between 1 and 500 Hz, and more specifically “1 to 50 Hz, 50 to 20 Hz or approximately 5 Hz”, which is in the range of 1 to 100 Hz (claim 15) and 5 to 200 HZ (claim 37) [0009]).
While Tai does disclose generically using feedback to control the system, Tai does not expressly disclose a biomedical sensor or data input source including instructions for adjusting parameters based on the feedback information. Hershey discloses that it was well known in the art of stimulation to include a biomedical sensor to collect feedback information and adjust the parameters based on the feedback information (e.g. adjustment of stimulation based on sensed paramaters as disclosed in [0018]). It would have been obvious to one having ordinary skill in the art to include the biomedical sensor and feedback system of Hershey in the device of Tai since such a modification would provide the system with the predictable results of a reliable means of providing stimulation.
Regarding claim 16, Tai additionally discloses wherein the first peripheral nerve is a tibial nerve (e.g. as described in [0030]). Tai does not expressly disclose a second peripheral nerve is a sapheous nerve, but the claim is an apparatus claim and the two nerves are close together, the device of Tai is capable of performing the functional limitation of stimulating the tibial nerve.
Regarding claims 17-18, Tai additionally discloses stimulation between 10 Hz and 20 Hz and between 5 Hz and 30 Hz. (e.g. stimulation using two channel system as described in [0042] wherein stimulation is between 1 and 500 Hz, and more specifically “1 to 50 Hz, 50 to 20Hz or approximately 5 Hz”, which is in the range of 1 to 100 Hz, [0009]).
Regarding claims 36 and 42, Hershey additionally disclose stimulating the vagus nerve (e.g. as disclosed in [0024] – [0030])
Claims 19-21 and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Tai and Hershey in further view of Yoo (US 2015/0148878, as previously cited).
Regarding claims 19-21 and 38-40, Tai discloses the claimed invention except the express mention that the feedback information comprises autonomic nervous system activity of the patient, heart rate variability, or information relating to inflammatory biomarker levels of the patient, but rather discloses the use of a wide variety of non-limiting physiological parameters such as blood pressure, acidic concentration, and/or temperature. Yoo teaches that it was well known in the art of stimulators for treating gastrointestinal problems to measure autonomic nervous system activity of the patient, heart rate variability, or information relating to inflammatory biomarker levels of the patient (e.g. sensor data that is processed by processor 58; [0346]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the sense feedback data of Yoo in the device of Tai since such a modification would provide the system with the predictable results of a reliable means of controlling the stimulation.
Claims 35 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Tai and Hershey in further view of Burnett (US 11,224,742).
Regarding claim 35 and 41, Tai and Hershey disclose the claimed invention except the express mention of the disease is selected from colitis, rheumatoid arthritis, and multiple sclerosis. Burnett discloses that it was well known the art of electrical stimulation to treat various conditions to treat arthritis (e.g. as disclosed in Col. 6, lines 30-45). It would have been obvious to one having ordinary skill in the art to include the treatment of arthritis as taught by Burnett in the device of Tai and Hershey in order to provide the system with the predictable results of a reliable means of treating a wide variety of conditions.
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 Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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