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 .
Election/Restrictions
Claims 17, 21-26 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
Applicant’s election without traverse of claims 1-16 & 18-20 in the reply filed on 6/8/2026 is acknowledged. Examiner notes that claim 17 was not withdrawn from the claim set but is hereby withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16, 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step 1:
Independent claim 1 is directed to a method, and thus, the claims all fall under one of the four patent eligible categories.
Under Step 2A, Prong 1:
Claim 1 recites steps comprising electrically stimulating different regions of the peripheral nerve; detecting activity from the stimulated regions; and correlating the detected activity from the stimulated regions to the presence of a fascicle or a portion of a fascicle at the stimulated regions.
Under broadest reasonable interpretation, these limitations appear to be directed to mental processes because they concern evaluating signal data which can be performed in the mind or with pen and paper. A trained clinician can compare the detected activity to signal data; make mental judgements correlating detected activity to tissue types and functions; then make determinations of the presence of fascicles. Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas under mental processes.
Dependent claim 3 recites additional limitations of detecting activity but appears to be directed to mental processes because it concerns observations, calculations, and judgments which can be performed in the mind with pen and paper.
Dependent claims 6 & 7 recite additional limitations wherein the detected activity is represented by a change in muscle contraction, a change in heart rate, a change in brain activity, a change in joint motion, a change in sensation, or combinations thereof; and from the group consisting of visual detection, verbal confirmation of sensation felt, imaging, impedance spectroscopy, optical computed tomography, electromyography (EMG), joint angle kinematics, nerve recording, cortical recording, electroencephalography (EEG), or combinations thereof but appears to be directed to mental processes because it further limits the abstract process of claim 1 by defining and selecting the detected activity and the method by which the detected activity is detected.
Dependent claims 8-9 recite additional limitations wherein the correlating comprises correlating the detected activity to a fascicle's function and fascicle’s type but appears to be directed to mental processes because it further limits the abstract process of claim 1 by defining correlating the detected activity as a fascicle’s function and type.
Dependent claim 10 recites additional limitations wherein the detected activity is correlated to a sensory fascicle, a motor fascicle, or combinations thereof but appears to be directed to mental processes because it further limits the abstract process of claim 1 by defining correlating the detected activity as a sensory and/or motor fascicle.
Dependent claims 11-13 recite additional limitations comprising a step of generating a map of fascicles in the peripheral nerve based on the correlating; and a map of fascicles based on fascicle function and fascicle type but appears to be directed to mental processes because they concern observations and judgements that can be performed in the mind with pen and paper. Claims 12 & 13 further limit the abstract process of claim 11 by defining fascicle function and type.
Dependent claims 15 & 16 recite additional limitations wherein the peripheral nerve is selected from the group consisting of a sensory nerve, a motor nerve, an autonomic nerve, a brachial plexus, a peroneal nerve, a femoral nerve, a lateral femoral cutaneous nerve, a sciatic nerve, a spinal accessory nerve, a tibial nerve, or combinations thereof; and comprises a sciatic nerve but appears to be directed to mental processes because it concerns observations and judgements which can be performed in the mind or with pen and paper and further limits the abstract process of claim 1.
Under Step 2A, Prong 2:
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claim 1 does not include any additional elements that integrate the abstract idea into a practical application. The steps of electrically stimulating and detecting activity are insignificant pre-solution activity (data gathering).
Claim 2 includes a support and steps of placing the peripheral nerve on said support wherein the support merely generally links the use of the judicial exception to a particular technological environment or field of use and is directed to pre-solution activity (data gathering).
Claims 3-5 include electrodes and steps of placing electrodes at different regions; aligned parallel; and span an entire width of the peripheral nerve wherein the electrodes only generally link the use of the judicial exception to a particular technological environment or field of use and are directed to pre-solution activity (data gathering); detecting activity is insignificant pre-solution activity (data gathering).
Claims 6-10 do not include any additional elements and only further define the correlating step of claim 1.
Claims 11-13 do not include any additional elements and include steps of generating a map based on correlating; and based on fascicle function and type; generating is insignificant post-solution activity (data outputting).
Claim 14 includes electrodes and steps of implanting electrodes into located fascicles wherein electrodes generally link the use of the judicial exception to a particular technological environment or field of use; implanting does not appear to integrate the claimed invention into a practical application because the implantation is performed by a person utilizing post-solutions determined by the claimed invention.
Claims 15-16 do not include any additional elements.
Claims 18-19 include a subject and a step of occurs in vivo wherein the subject generally links the use of the judicial exception to a particular technological environment or field of use and appears to be directed to pre-solution activity (data gathering).
Claim 20 does not include any additional elements; examiner notes that the step of repairing does not appear to integrate the claimed invention, for the same reason as claim 14, even with the inclusion of an additional element.
Under Step 2b:
Claims 1-16, 18-20 fail to include any additional elements that, alone or in combination, amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “support”, “electrodes”, and “subject” are well-understood, routine, and conventional activities previously known in the field of electrostimulation as indicated in the following references:
US 2021/0315638 A1:
See [0029], Fig. 6 for support
See [0029], Fig. 6 for electrode
See [0006] patient’s body for subject
WO 2019/122817 A1:
See [0007] for support
See [0029] for electrode
See [0035] for subject
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-15, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley et al (US Pre Grant Publication 2021/0315638 A1).
Regarding claim 1, Townley teaches a method of locating or mapping a fascicle or a portion of a fascicle of a peripheral nerve ([0060]; target site is a nerve, then generally associated with peripheral nerve fibers, [0067]; system 100 locates nerves), said method comprising:
electrically stimulating different regions of the peripheral nerve ([0070]; peripheral nervous system, [0125], Fig. 9A & 9B; non-therapeutic stimulating energy used to sense properties associated with different types of tissue),
detecting activity from the stimulated regions ([0125], Fig. 9B; console 104 determines anatomy at target site); and
correlating the detected activity from the stimulated regions to the presence of a fascicle or a portion of a fascicle at the stimulated regions ([0125], Fig. 9B; end effector 214 detects neural fibers (portion of fascicle).
Regarding claim 2, Townley teaches the method of claim 1, and further teaches comprising a step of placing the peripheral nerve on a support (240, Fig. 4) prior to the electrical stimulation ([0124]; struts 240 form frame and position electrodes 244 onto target site).
Regarding claim 3, Townley teaches the method of claim 1, and further teaches wherein the electrical stimulation occurs by placing a plurality of electrodes (244, Fig. 9B) at different regions of the peripheral nerve, individually stimulating each of the plurality of electrodes, and detecting activity from each of the plurality of electrodes ([0124], struts 240 (Fig. 4) contact multiple locations with electrodes 244 along target site; deliver non-therapeutic stimulating energy to sense bioelectric properties).
Regarding claim 4, Townley teaches the method of claim 3, and further teaches wherein the plurality of electrodes are aligned parallel to one another (Fig. 4; electrodes 244 parallel).
Regarding claim 5, Townley teaches the method of claim 3, and further teaches wherein the plurality of electrodes span an entire width of the peripheral nerve (Fig. 4; peripheral nerve that fits between two adjacent strut 240 pairs necessarily requires electrodes to span entire width of nerve).
Regarding claim 6, Townley teaches the method of claim 1, and further teaches wherein the detected activity is represented by a change in muscle contraction ([0202]; muscular activation), a change in heart rate, a change in brain activity, a change in joint motion, a change in sensation, or combinations thereof.
Regarding claim 7, Townley teaches the method of claim 1, and further teaches wherein the detected activity is detected by a method selected from the group consisting of visual detection ([0134]; detected complex impedance displayed to user to visualize structures), verbal confirmation of sensation felt, imaging, impedance spectroscopy, optical computed tomography, electromyography (EMG), joint angle kinematics, nerve recording, cortical recording, electroencephalography (EEG), or combinations thereof.
Regarding claim 8, Townley teaches the method of claim 1, and further teaches wherein the correlating comprises correlating the detected activity to a fascicle's function ([0202]; function of neural tissue).
Regarding claim 9, Townley teaches the method of claim 1, and further teaches wherein the correlating comprises correlating the detected activity to a fascicle's type ([0185]; differentiate between different types of neural tissue).
Regarding claim 10, Townley teaches the method of claim 9, and further teaches wherein the detected activity is correlated to a sensory fascicle ([0135]; distinguish between targeted parasympathetic nerves and non-targeted sensory nerves), a motor fascicle, or combinations thereof.
Regarding claim 11, Townley teaches the method of claim 1, and further teaches further comprising a step of generating a map of fascicles in the peripheral nerve based on the correlating ([0236]; measurements converted to map/image).
Regarding claim 12, Townley teaches the method of claim 11, and further teaches wherein the map comprises a map of fascicles based on fascicle function ([0236]; map of bioelectric properties; properties determine fascicle type and function).
Regarding claim 13, Townley teaches the method of claim 11, and further teaches wherein the map comprises a map of fascicles based on fascicle type ([0236]; map of anatomical structure).
Regarding claim 14, Townley teaches the method of claim 1, further teaches comprising a step of implanting one or more electrodes into one or more of the located fascicles ([0006]; determine desired effect, then implant permanent electrode).
Regarding claim 15, Townley teaches the method of claim 1, and further teaches wherein the peripheral nerve is selected from the group consisting of a sensory nerve, a motor nerve, an autonomic nerve ([0135]; distinguish between targeted parasympathetic nerves and non-targeted sensory nerves), a brachial plexus, a peroneal nerve, a femoral nerve, a lateral femoral cutaneous nerve, a sciatic nerve, a spinal accessory nerve, a tibial nerve, or combinations thereof.
Regarding claim 18, Townley teaches the method of claim 1, and further teaches wherein the method occurs in vivo in a subject ([0059-0060]; clinician performs procedure on a patient with device 102).
Regarding claim 19, Townley teaches the method of claim 18, and further teaches wherein the subject is a human being ([0059-0060]; clinician performs procedure on a patient with device 102).
Regarding claim 20, Townley teaches the method of claim 1, and further teaches comprising a step of repairing the peripheral nerve ([0153]; ablation of target neural tissue).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al (US Pre Grant Publication 2021/0315638 A1), in view of Han et al (US Pre Grant Publication 2013/0030510 A1).
Regarding claim 16, Townley teaches the method of claim 1, but does not disclose wherein the peripheral nerve comprises a sciatic nerve.
However, Han teaches a system and a method for electrical stimulation of nerves. Han is analogous to the claimed invention because it is reasonably pertinent to the problem of stimulating peripheral nerves.
Han further teaches, wherein the peripheral nerve comprises a sciatic nerve ([0030]; calcium ions associated with peripheral nerve excitability; A-fibers in sciatic nerves of frogs exhibit peripheral nerve excitability associated with calcium ion concentrations).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Townley, with a sciatic nerve, as taught by Han. One of ordinary skill in the art would have been motivated to make these modifications to improve neurostimulation therapy by suppressing unwanted nerve signals such as pain originating from the legs (Han, [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Donega et al (WO 2019122817 A1) discloses a system and a method for nerve stimulation; position of peripheral nerve fascicles determined by correlation of signal data [003]; nerve cuff 7 wraps around nerve with parallel electrodes 17 that surround entire width of nerve ([035], Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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