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 February 4, 2026 have been fully considered but they are not persuasive.
Applicant argues that “Bernstein fails to disclose or suggest a controller configured to receive structural information and functional information and that is configured to control a location of selective stimulation of a position within a part of the peripheral nervous system based on the structural information and the functional information. Indeed, there are no teachings in Bernstein directed in any way to using structural or functional information of the neural tissue to control a stimulation location. In fact, Bernstein does not even disclose sensing both structural information and functional information” (page 7 of Remarks). However, the examiner respectfully disagrees.
Claim 1 recites “wherein the sensor unit is configured to determine structural information of the part of the peripheral nervous system and functional information of the part of the peripheral nervous system based on at least one sensing mode of the sensor unit”. As previously made of record, “the sensor unit is configured to determine structural information of the part of the peripheral nervous system and functional information of the part of the peripheral nervous system based on at least one sensing mode of the sensor unit ([0020, 0024]; “The tissue interface is also configured to monitor the target tissue by recording electrical activity of the target tissue with one or more of the electrodes and image the target tissue with one or more of the ultrasound transducers”[0020])”. Imaging of target tissue provides “structural information” and recording of electrical activity provides “functional information”. As such, Bernstein et al. does in fact disclose “the sensor unit is configured to determine structural information of the part of the peripheral nervous system and functional information of the part of the peripheral nervous system based on at least one sensing mode of the sensor unit”.
For similar reasons, claim 15 which recites “determining structural information of the part of the peripheral nervous system; determining functional information of the part of the peripheral nervous system” also remains rejected under Bernstein et al. for reasons previously made of record and discussed above.
Additionally, regarding the Applicant’s argument that Bernstein fails to disclose or suggest a controller “that is configured to control a location of selective stimulation of a position within a part of the peripheral nervous system based on the structural information and the functional information”. However the examiner respectfully disagrees.
As previously made of record, Bernstein et al. teaches “a controller (controller, depicted as 110 in Figure 1) configured to receive the structural information and the functional information (memory, depicted as 120 in Figure 1, of the controller, [0021, 0023]) and configured to control a location of the selective stimulation of the position within the part of the peripheral nervous system based on the structural information and the functional information ([0024, 0030-0031, 0038]).
Bernstein et al. discloses “the transducers 106 can be used to both image and to stimulate the tissue 104. Stimulation of tissue, such as neurons, with ultrasonic energy from the transducers 106 can be advantageous in comparison to stimulating the tissue with only electrical energy from the electrodes 108. For example, ultrasonic energy may travel through connective and other fibrous tissue better than electrical energy. Because the patient's body naturally encapsulates foreign objects with a fibrous tissue electrical stimulation may become less effective over time; however, the ultrasonic energy can still be effective in stimulating target tissue even after the cuff 102 is encapsulated by the patient's body” ([0030]).
As such, Bernstein et al. discloses providing ultrasonic energy to a particular location of a position within the part of the peripheral nervous system when the structural information and functional information indicate a presence of fibrous tissue, which can develop over time. Thus, Bernstein et al. does in face disclose control of how stimulation is provided to “a location of the selective stimulation of the position within the part of the peripheral nervous system based on the structural information and the functional information”.
Therefore, for the reasons stated above and previously made of record, claim 1 remains rejected under Bernstein et al. as previously made of record and presented below.
For similar reasons, claim 15 which recites “determining a location within the part of the peripheral nervous system for which selective stimulation is desired, wherein the location of the selective stimulation within the part of the peripheral nervous system is determined based on the structural information and the functional information” also remains rejected under Bernstein et al. for reasons previously made of record and discussed above.
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.
Claims 1-11 and 15 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernstein et al. (US 20160235329 A1).
As to claim 1, Bernstein et al. discloses an apparatus for stimulating a part of a peripheral nervous system (Abstract) comprising: a sensor unit (system, depicted as 100 in Figure 1) comprising at least one ultrasound transducer (depicted as 106 in Figure 1; [0021]) and at least one pair of electrodes (depicted as 108 in Figure 1; [0021]) configured to be arranged in different locations in relation to the part of the peripheral nervous system (Figure 1), wherein the at least one ultrasound transducer is configured to transmit ultrasound into the part of the peripheral nervous system ([0023, 0030-0031, 0038]) and wherein the at least one pair of electrodes is configured to detect electrical signals ([0021-0023, 0031, 0038]) in the part of the peripheral nervous system ([0036]; Figure 1), wherein the sensor unit is configured to determine structural information of the part of the peripheral nervous system and functional information of the part of the peripheral nervous system based on at least one sensing mode of the sensor unit ([0020, 0024]; “The tissue interface is also configured to monitor the target tissue by recording electrical activity of the target tissue with one or more of the electrodes and image the target tissue with one or more of the ultrasound transducers”[0020]), wherein the sensor unit is configured to, in the at least one sensing mode ([0020-0021, 0030-0031]), perform ultrasound detection and/or electrical signal detection based on transmitting ultrasound into the part of the peripheral nervous system ([0030-0031]); a stimulation unit (microprocessor, depicted as 114 in Figure 1) configured to transmit a stimulation signal into the part of the peripheral nervous system for selective stimulation of a position within the part of the peripheral nervous system ([0030-0031]); and a controller (controller, depicted as 110 in Figure 1) configured to receive the structural information and the functional information (memory, depicted as 120 in Figure 1, of the controller, [0021, 0023]) and configured to control a location of the selective stimulation of the position within the part of the peripheral nervous system based on the structural information and the functional information ([0024, 0030-0031, 0038]).
As to claim 2, Bernstein et al. discloses the sensor unit is configured to determine structural information of the part of the peripheral nervous system based on a first sensing mode (“In some implementations, the ultrasound transducers 106 are used to detect the presence of scar tissue that may accumulate around the tissue interface 102 over time. For example, the increase in the acoustic mismatch between the ultrasound transducer 106 and the tissue target can result in a larger echo return, which can signal the development of scar tissue of the tissue target” [0024]) and determine functional information of the part of the peripheral nervous system based on a second sensing mode (“In some implementations, the ultrasound transducers 106 are used to image the changes that within the target tissue in response to the ultrasonic and/or electrical stimulation to the target tissue.” [0024]). Additionally, ([0030-0031, 0038]).
As to claim 3, Bernstein et al. discloses the controller is configured to receive the structural information and configured to control a selective sensing by the sensor unit of functional information of the part of the peripheral nervous system for determining functional information in selected locations of the part of the peripheral nervous system ([0021-0023, 0026]; Figure 1).
As to claim 4, Bernstein et al. discloses the sensor unit is configured to determine functional information of the part of the peripheral nervous system based on an acousto-electric sensing mode, wherein the at least one ultrasound transducer is configured to transmit ultrasound pulses into the part of the peripheral nervous system and the at least one pair of electrodes is configured to detect acousto-electric interaction between the ultrasound pulses and the part of the peripheral nervous system, wherein the acousto-electric interaction is modulated by neural activity ([0027-0031]).
As to claim 5, Bernstein et al. discloses the stimulation unit comprises a plurality of stimulation elements (Figures 1-2; [0021]) configured to be arranged in relation to the part of the peripheral nervous system (Figures 1-2), wherein the stimulation elements comprise ultrasound transducers and/or electrodes for providing the selective stimulation of the part of the peripheral nervous system by an ultrasound stimulation signal and/or an electrical stimulation signal (Figures 1-2; [0026, 0030-0031]).
As to claim 6, Bernstein et al. discloses the sensor unit and the stimulation unit are arranged in a carrier (polymer backing, depicted as 202 in Figure 2) configured to conform to an outer surface of the part of the peripheral nervous system (Figures 1-2; [0026-0027]).
As to claim 7, Bernstein et al. discloses the carrier has form of a cuff configured to be arranged around a nerve (Figures 1-2; [0026]).
As to claim 8, Bernstein et al. discloses the sensor unit comprises a set of ultrasound transducers and a set of electrodes ([0021, 0026, 0028]), wherein the set of ultrasound transducers and the set of electrodes are arranged in a sensing area of the carrier with the ultrasound transducers arranged intermixed with electrodes such that at least one ultrasound transducer is arranged between two electrodes (Figures 1-4B; [0028, 0032-0033]).
As to claim 9, Bernstein et al. discloses the sensor unit comprises a first set and a second set of ultrasound transducers and a first set and a second set of electrodes (Figures 1-4B), wherein the first set of ultrasound transducers and the first set of electrodes are arranged in a first sensing area of the carrier (Figures 1-4B) and the second set of ultrasound transducers and the second set of electrodes are arranged in a second sensing area of the carrier (Figures 1-4B), and wherein the first sensing area and the second sensing area are arranged on opposite sides of a stimulation area of the carrier (Figures 1-2 and 4A-4B).
As to claim 10, Bernstein et al. discloses the carrier comprises an acoustically transparent material such that the carrier is configured to be arranged in relation to the part of the peripheral nervous system with the acoustically transparent material between the part of the peripheral nervous system and ultrasound transducers ([0027]).
As to claim 11, Bernstein et al. discloses the controller is further configured to control one or more of a size of the location of the selective stimulation of the part of the peripheral nervous system, a stimulation modality of the stimulation signal, a type of effect by the stimulation signal on the part of the peripheral nervous system, and timing of the stimulation signal ([0021-0023]).
As to claim 15, Bernstein et al. discloses controlling stimulation of a part of a peripheral nervous system, said method comprising: determining structural information of the part of the peripheral nervous system ([0024, 0038]); determining functional information of the part of the peripheral nervous system ([0024, 0030-0031]); and determining a location within the part of the peripheral nervous system for which selective stimulation is desired, wherein the location of the selective stimulation within the part of the peripheral nervous system is determined based on the structural information and the functional information ([0024, 0030-0031, 0038])
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.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein et al. (US 20160235329 A1).
As to claims 12-14, Bernstein et al. discloses the invention substantially as claimed but does not explicitly disclose the incorporation of a biomarker sensor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the peripheral nerve stimulation system to incorporate a biomarker sensor in order to provide the predictable results of ensuring proper position and location for implantation of the neural stimulation device in order to provide the predictable results to optimize treatment to meet specific patient therapeutic needs and requirements.
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796