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
The 35 U.S.C. 112(f) interpretation and 35 USC § 101 have been withdrawn as the applicant has amended the claim language “a motion detector” to “an electrode”.
Applicant’s arguments, filed 2/28/2026, with respect to the rejection(s) of claim(s) 1-6 and 8-10 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under Kilgard in view of Einav. The new grounds of rejection are necessitated by the applicant’s heavily amended claims and thus the rejection is made final.
In response to the applicant’s persuasive argument that “Kilgard for example merely triggers stimulation after a rat travels a certain distance on a wheel or after a lever is pressed, which is not the same criteria as a threshold for "contraction" as recited in claim 1”, the examiner has cited Einav to illustrate it is known to use such a modification as set forth in [0095] to provide rehabilitative stimulation after stroke that assists in contracting only the intended muscle (e.g. see [0095]). It would have been obvious to PHOSITA to send the stimulation signal based on the voluntary muscle electrical activity feedback signal meeting a minimum muscle electrical activity threshold criteria for contraction as taught by Einav in the system/method of Kilgard, since said modification would provide the predictable results of rehabilitative stimulation after stroke that assists in contracting only the intended muscle.
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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kilgard et al. (Pub. No.: US 2015/0073493 A1); hereinafter referred to as “Kilgard”, in view of Dietrich et al. (U.S. Pat. No. 7,797,042 B2), (which is referenced in [0097] of Kilgard); hereinafter referred to as “Dietrich”, in view of Einav et al. (Pub. No.: US 2008/0234781 A1); hereinafter referred to as “Einav”.
Regarding claim 1, Kilgard discloses an electrode configured to detect muscle electrical activity (e.g. see [0110]. Note: EMG signals can only be measured with electrodes) and generate a voluntary muscle electrical feedback signal (e.g. see [0110]); a vagus nerve stimulation module (e.g. see [0097]); and a controller (e.g. see figures 6 and 7 element 604, [0098]-[0102]) configured to receive the voluntary muscle electrical feedback signal (e.g. see [0110]) from the electrode and send a stimulation signal to the transcutaneous auricular vagus nerve stimulation module with a delay of 2 seconds or less (e.g. see [0134] (e.g. “Stimulations were delivered approximately 75 ms after the wheel reached 145.degree. or the lever triggered the second press”).
Kilgard discloses a vagus nerve stimulation module (e.g. see [0097]. NOTE: Kilgard discloses in [0097] “Stimulation of the vagus nerve may be done at other sites along the vagus nerve and branches of the vagus nerve” and “An example of a transcutaneous electrical stimulation system that could be adapted for use in the described therapy may be found in U.S. Pat. No. 7,797,042”) but does not explicitly disclose a transcutaneous auricular vagus nerve stimulation module. Dietrich (U.S. Pat. No. 7,797,042) teaches it is known to use such a modification as set forth in column 6 lines 7-23, and column 6 lines 65 thru column 7 line 8 to provide an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person (e.g. see column 3 lines 45-53). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a transcutaneous auricular vagus nerve stimulation module as taught by Dietrich in the system/method of Kilgard, since said modification would provide the predictable results of an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person.
Kilgard and Dietrich disclose the invention but are silent as to the stimulation signal is sent based on the voluntary muscle electrical activity feedback signal meeting a minimum muscle electrical activity threshold criteria for contraction. Einav teaches it is known to use such a modification as set forth in [0095] to provide rehabilitative stimulation after stroke that assists in contracting only the intended muscle (e.g. see [0095]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to send the stimulation signal based on the voluntary muscle electrical activity feedback signal meeting a minimum muscle electrical activity threshold criteria for contraction as taught by Einav in the system/method of Kilgard and Dietrich, since said modification would provide the predictable results of rehabilitative stimulation after stroke that assists in contracting only the intended muscle.
Regarding claim 2, Kilgard discloses a vagus nerve stimulation module (e.g. see [0097]. NOTE: Kilgard discloses in [0097] “Stimulation of the vagus nerve may be done at other sites along the vagus nerve and branches of the vagus nerve” and “An example of a transcutaneous electrical stimulation system that could be adapted for use in the described therapy may be found in U.S. Pat. No. 7,797,042”) but does not explicitly the transcutaneous auricular vagus nerve stimulation module comprise a surface electrode. Dietrich teaches it is known to use such a modification as set forth in column 6 lines 7-23, and column 6 lines 65 thru column 7 line 8 to provide an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person (e.g. see column 3 lines 45-53). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a surface electrode transcutaneous auricular vagus nerve stimulation module as taught by Dietrich in the system/method of Kilgard and Einav, since said modification would provide the predictable results of an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person.
Regarding claim 3, Kilgard discloses the stimulation signal comprises an electrical intensity greater than 0 mA and up to 10 mA, a frequency of greater than 0Hz and up to 100Hz, and a pulse width greater than 0µs and up to 500µs. (e.g. see [0134]. “0.8 mA, 100µs pulse width, and 30 Hz”).
Regarding claim 4, Kilgard discloses the stimulation signal comprises an electrical intensity greater than 0.5mA and up to 5mA and a pulse width greater than 100µs and up to 250µs (e.g. see [0134]. “0.8 mA and about 100µs pulse width”). Kilgard further discloses using a frequency of 30Hz but is silent as to a frequency of 10 Hz and up to 25 Hz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Kilgard with a frequency range of 10Hz to 25Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] (NOTE: Kilgard establishes that frequency is a result effective variable in [0162]-[0163] where the reference discloses frequency can be determined experimentally and may differ depending on differing stimulation conditions) and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding claim 5, Kilgard discloses a vagus nerve stimulation module (e.g. see [0097]. NOTE: Kilgard discloses in [0097] “Stimulation of the vagus nerve may be done at other sites along the vagus nerve and branches of the vagus nerve” and “An example of a transcutaneous electrical stimulation system that could be adapted for use in the described therapy may be found in U.S. Pat. No. 7,797,042” and “Vagus nerve stimulation may be delivered with electrodes placed in direct contact (or proximate to) the left cervical vagus nerve, in the patient's neck”) but does not explicitly the transcutaneous auricular vagus nerve stimulation module comprises a surface electrode configured to interface a head or neck area. Dietrich teaches it is known to use such a modification as set forth in column 6 lines 7-23, and column 6 lines 65 thru column 7 line 8 to provide an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person (e.g. see column 3 lines 45-53). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the transcutaneous auricular vagus nerve stimulation module comprising a surface electrode configured to interface a head or neck area as taught by Dietrich in the system/method of Kilgard and Einav, since said modification would provide the predictable results of an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person.
Regarding claim 6, Kilgard discloses a vagus nerve stimulation module (e.g. see [0097]. NOTE: Kilgard discloses in [0097] “Stimulation of the vagus nerve may be done at other sites along the vagus nerve and branches of the vagus nerve” and “An example of a transcutaneous electrical stimulation system that could be adapted for use in the described therapy may be found in U.S. Pat. No. 7,797,042”) but does not explicitly the transcutaneous auricular vagus nerve stimulation module is configured to stimulate an auricular branch of the vagus nerve. Dietrich teaches it is known to use such a modification as set forth in column 6 lines 7-23, and column 6 lines 65 thru column 7 line 8 to provide an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person (e.g. see column 3 lines 45-53). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the transcutaneous auricular vagus nerve stimulation module being configured to stimulate an auricular branch of the vagus nerve as taught by Dietrich in the system/method of Kilgard, since said modification would provide the predictable results of an apparatus which is particularly simple and especially safe for the patient, removable from the body where appropriate quickly and safely, enables non-invasive stimulation in particular of portions of the vagus nerve and is very comfortable to wear, and which does not require force over a fabrication or fitting by a skilled person.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kilgard, Dietrich, and Einav as applied to claim 1 above, and further in view of Lundqvist (Pub. No.: US 2012/0245483 A1).
Regarding claims 8-10, Kilgard, Dietrich, and Einav disclose the claimed invention but are silent as to the motion detection feedback signal is based on a plurality of muscle activity feedback signals, the muscle activity feedback signals are based on two or more muscles from the group consisting of flexor carpi radilalis, flexor capri ulnaris, biceps, triceps, anterior deltoid and middle deltoid, and the muscle activity signals are based on: at least a first signal from an upper limb indicative of movement from one or more of a trapezius, deltoid, biceps brachii, triceps, flexor/extensor carpi radialis, flexor/extensor digitorum, and flexor/extensor pollicis brevis; and at least a second signal from a lower limb indicative of movement from one or more of a gluteus maximus, quadriceps femoris, anterior compartment of the leg, quadriceps femoris, foot inverters and evertors, biceps femoris, semitendinosus and semimembranosus. Lundqvist teaches that it is known to use such a modification as set forth in [0076], claim 8 of Lundqvist, [0184] (NOTE: Claim 8 of Lundqvist addresses the claimed muscles. [0076] discloses one pair of arm EMG electrodes and one pair of leg EMG electrodes. [0184] discloses the application of stroke rehabilitation.) to provide improved muscle recovery after stroke (e.g. see [0184]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use EMG feedback for muscle stimulation for stroke rehabilitation in the muscles dictated in applicant’s claims 8-10 as taught by Lundqvist in the system of Kilgard, Dietrich, and Einav, since said modification would provide the predictable results of improved muscle recovery after stroke.
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.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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