DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 23 December 2024 has been considered by the Examiner.
Claim Objections
3. Claim 9 is objected to because of the following informality.
Claim 9 contains a minor typographical error.
Claim 9, line 1: The Examiner suggests changing “wherein at least two electrodes” to “wherein the at least two electrodes”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
4. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
5. Claims 1, 3-6, 13, and 15 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Shah et al. (WO 2020/198120 A1, with citations to the corresponding US Publication No. 2022/0175320 A1).
Regarding claims 1 and 15, Shah teaches a device and a method for electrically stimulating at least one nerve (the neuromodulation system 100 comprises a pulse generator 140 that generates a signal to deliver an electrical current to a nerve via electrodes 165 [0063-0065]), the device comprising:
a bendable substrate configured to be arranged at least partially surrounding the nerve so as to define an inner surface of the substrate that faces an outer surface (5) of the nerve (the neuromodulation system 100 comprises a thin-film neural interface 160 which is a bendable or flexible substrate [0054-0055, 0062-0063, 0067]. Specifically, the thin-film neural interface 160 (e.g., flexible substrate) comprises cuff electrodes which are known to wrap around the nerve [0062, 0067]); and
at least two electrodes, at least one of the electrodes of the at least two electrodes being a surface electrode and at least one of the electrodes of the at least two electrodes being an intraneural electrode, the surface electrode and the intraneural electrode being arranged on the inner surface of the substrate, wherein the surface electrode is configured to establish an electric connection with a part of the nerve on the outer surface of the nerve, and wherein the intraneural electrode is configured to penetrate the outer surface of the nerve to establish an electric connection with a part of the nerve within the nerve (the inner surface of thin-film neural interface 160 may include a plurality of electrodes 165 using various shapes and patterns to form certain types of interfaces (e.g., spiral cuff electrodes, epidural electrodes, linear electrodes, and intraneural electrodes) [0067]. For example, the thin-film neural interface 160 may include cuff electrodes and/or linear electrodes which are considered to be surface electrodes which contact the outer surface of the nerve to establish an electrical connection [0064, 0067]. Meanwhile, the thin-film neural interface 160 may also include intraneural electrodes (e.g. needle or spike electrodes) which are known to penetrate the outer surface of the nerve to establish an electrical connection within the nerve [0064, 0067]).
Regarding claim 3, Shah teaches wherein the device is configured to supply electric current via a respective electrode of the at least two electrodes to a respective part of the nerve (the neuromodulation system 100 comprises a pulse generator 140 that generates a signal to deliver an electrical current to a nerve via electrodes 165 [0063-0065]) and/or wherein the device is configured to receive a neuro-signal from a respective part of the nerve via the respective electrode (the neuromodulation system 100 comprises a controller 145 that controls the stimulation parameters based on determined or sensed electrical activity and physiological responses via the electrodes 165 and sensors [0063-0065]).
Regarding claim 4, Shah teaches wherein the substrate comprises at least one connector, wherein the connector comprises at least two electrically conducting channels (the connector or cable 155 consist of one or more conductive traces 175 which are routed through the wiring layer on the thin-film neural interface 160 (e.g., flexible substrate) to connect with the electrodes 165 and the sensors [0062, 0066-0067]), wherein at least one of the conducting channels is an electric current channel and/or at least one of the conducting channels is a neuro-signal channel (the conductive traces 175 are connected to the electrodes 165 and the sensors [0064, 0066-0067]. The Examiner respectfully submits that the conductive traces 175 that provide stimulation signals to electrodes 165 are considered to be the electric current channels [0064, 0066-0067]. Meanwhile, the conductive traces 175 that receive sensing signals from the sensors from the sensor are considered to be the neuro-signal channels [0064, 0066-0067]. As stated previously in claim 3, the neuromodulation system 100 comprises a controller 145 that controls the stimulation parameters based on determined or sensed electrical activity and physiological responses via the electrodes 165 and sensors [0063-0065]), wherein the at least two electrically conducting channels are connected to a respective electrode, wherein one end of the electric current channel is connected or is connectable to an electric energy source in order to supply electric current to a part of the nerve (the one or more conductive traces 175 are routed through the wiring layer on the thin-film neural interface 160 (e.g., flexible substrate) to connect with the electrodes 165 and the sensors [0062, 0066-0067]. Furthermore, the one or more conductive traces 175 are electrically connected to an energy source or pulse generator 140 to supply the electrical current to the electrodes 165 [0064, 0066-0067]).
Regarding claim 5, Shah teaches wherein the device comprises a control unit that is configured to adjust a property of the electric current that is transmitted to a respective electrode (the neuromodulation system 100 comprises a controller 145 that controls the stimulation parameters based on determined or sensed electrical activity and physiological responses via the electrodes 165 and sensors [0063-0065]).
Regarding claim 6, Shah teaches wherein the device comprises a recorder which is configured to record at least one neuro-signal from at least one part of the nerve and which is connected to the control unit in order to transmit a signal corresponding to the recorded neuro-signal from at least one part of the nerve to the control unit, such that the control unit is adapted to adjust a property of the electric current that is transmitted to a respective electrode to stimulate the at least one part of the nerve based on the at least one neuro-signal recorded by the recorder (the neuromodulation system 100 comprises sensors that are configured to record physiological response (e.g., neural signals) during stimulation [0064, 0067]. Specifically, the electrodes 165 are configured to provided the stimulation to the nerve [0064, 0066-0067]. Furthermore, the controller 145 that controls the stimulation parameters based on determined or sensed electrical activity and physiological responses via the sensors [0063-0065]).
Regarding claim 13, Shah teaches wherein the substrate is a nerve cuff comprising a flexible material for wrapping the nerve cuff around the nerve (the neuromodulation system 100 comprises a thin-film neural interface 160 which is a bendable or flexible substrate [0054-0055, 0062-0063, 0067]. Specifically, the thin-film neural interface 160 (e.g., flexible substrate) comprises cuff electrodes which are known to wrap around the nerve [0062, 0067]).
Claim Rejections - 35 USC § 103
6. 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.
7. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shah et al in view of Wahlstrand et al. (US 2006/0206163 A1).
Regarding claim 2, Shah teaches wherein the intraneural electrode is a spike extending from the inner surface of the substrate and arranged to penetrate the outer surface of the nerve and configured to establish the electric connection with a part of the nerve within the nerve (the inner surface of the thin-film neural interface 160 (e.g., flexible substrate) may include a plurality of electrodes 165 using various shapes and patterns to form certain types of interfaces (e.g., spiral cuff electrodes, epidural electrodes, linear electrodes, and intraneural electrodes) [0062, 0067]. For example, the thin-film neural interface 160 may also include intraneural electrodes which are known to consist of spikes or needles that penetrate the outer surface of the nerve to establish an electrical connection within the nerve [0064, 0067]).
Shah does not explicitly teach wherein the spike comprises a partially insulated part made of electrically conductive material, and wherein a tip of the spike is non-insulated, so that the electric connection is established with the part of the nerve within the nerve.
The prior art by Wahlstrand is analogous to Shah, as they both teach intraneural electrodes (e.g., needle or spike) that is provides stimulation to a nerve ([0068-0069]).
Wahlstrand teaches wherein the spike comprises a partially insulated part made of electrically conductive material, and wherein a tip of the spike is non-insulated, so that the electric connection is established with the part of the nerve within the nerve (“each needle electrode 22 may be insulated by an outer sheath that extends along substantially the entire length of the needle electrode, leaving a distal tip exposed for delivery of stimulation energy” [0069]. In other words, the distal tip of the needle electrodes 22 establishes the electrical connection with the target nerve [0068-0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the spike suggested by Shah to include a partially insulated portion and a tip having an uninsulated portion, as taught by Wahlstrand. The advantage of such modification will allow controlling the depth at which the stimulation is delivered (see paragraph [0069] by Wahlstrand).
8. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shah et al in view of Shah et al. (US 2016/0296130 A1, referred to herein as “Shah-130”).
Regarding claim 7, Shah teaches substrate comprises a central section (the Examiner respectfully submits that the thin-film neural interface 160 (e.g., flexible substrate) would inherently have a center region [0062, 0067]).
Shah does not explicitly teach wherein a longitudinal direction of the substrate is substantially parallel to an axis of the nerve when the substrate is placed on the nerve.
The Examiner respectfully submits, as Shah teaches the use of a substrate being placed on the nerve (the thin-film neural interface 160 (e.g., flexible substrate) comprises electrodes 165 which are placed on the nerve [0062, 0064, 0067]), configuring the longitudinal direction of the substrate to be substantially parallel to an axis of the nerve when the substrate is placed on the nerve would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Shah does not explicitly teach wherein the inner surface of the substrate corresponding to the central section comprises a central conductive surface pad extending at least 90% of a width of the central section, the width being substantially perpendicular to the longitudinal direction and within a plane of the substrate, and wherein the central conductive surface pad is configured to establish the electric connection with a respective part of the nerve on the outer surface of the nerve.
The prior art by Shah-130 is analogous to Shah, as they both teach a neural interface comprising a substrate and electrodes ([0028]).
Shah-130 teaches wherein the inner surface of the substrate comprises a central conductive surface pad (the neural interface component 12 comprises the conductive pads 32 are disposed within a region 34 of the substrate 24 [0028]), wherein the central conductive surface pad is configured to establish the electric connection with a respective part of the nerve on the outer surface of the nerve (the conductive pads 32 are disposed on the substrate 24 which is coupled to the target region of the human body [0028]. Specifically, the conductive pads 32 conduct electrical signals to the electrically conductive elements 26 (e.g., electrodes) on the substrate 24 to stimulate the target region (e.g., nerve) [0028])
Shah-130 does not explicitly teach the central conductive surface pad extending at least 90% of a width of the central section, the width being substantially perpendicular to the longitudinal direction and within a plane of the substrate.
The Examiner respectfully submits, as Shah-130 teaches the use of a substrate having a central section and a central conductive surface pad (see the explanation above), configuring the central conductive surface pad to extend at least 90% of a width of the central section and the width to be substantially perpendicular to the longitudinal direction and within a plane of the substrate would be a matter of changing the size and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Shah’s the substrate to include a central conductive surface pad that extends along the width of the central section and establishes an electrical connection with the nerve, as suggested by Shah-130. This medication is beneficial as the conductive surface pad will improve the conductivity of the electrodes during stimulation (see paragraph [0028] by Shah-130).
9. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. in view of Shah-130, further in view of Romero-Ortega et al. (US 2019/0290902 A1).
Regarding claim 8, Shah in view of Shah-130 suggests the device according to claim 7. Shah and Shah-130 wherein the device is configured to apply electric current within a frequency range between about 4 kHz to 100 kHz via the central conductive surface pad or between about 10 kHz and 20 kHz so that a virtual cut of the nerve in a longitudinal direction substantially parallel to the axis of the nerve is performed, in which a part of the nerve on one side of the central section in the longitudinal direction of the nerve is adapted to be treated independent of the part of the nerve on an other side of the central section.
The prior art by Romero-Ortega is analogous to Shah, as they both teach neuromodulation devices ([abstract]).
Romero-Ortega teaches wherein the device is configured to apply electric current within a frequency range between about 1 kHz to 100 kHz via the central conductive surface pad (the contact pads are coupled to the electrodes for electrical stimulation [0217]. Specifically, the electrical stimulation has a frequency between about 1 kHz and 100 kHz [0235]).
Romero-Ortega does not explicitly teach the frequency to range between about 4 kHz to 100 kHz.
However, Applicant’s claimed frequency range of about 4 kHz to 100 kHz lies entirely within Romero-Ortega’s frequency range of about 1 kHz to 100 kHz ([0235]). Therefore, a prima facie case of obviousness exists. Based on the overlapping range a person having ordinary skill in the art would have found it obvious to use a frequency of about 4 kHz to 100 kHz (MPEP 2144.05). The advantage of such modification may improve the regeneration of the nerve during the electrical stimulation (see paragraphs [0126, 0217, 0235] by Romero-Ortega).
The Examiner respectfully submits that the remaining limitations are not required due to the “or” terminology. For example, the remaining limitations are drawn to using a frequency of 10 kHz to 20 kHz to form a virtual cut of the nerve in a longitudinal direction to the axis of the nerve. This limitation is not required, as the Examiner has addressed the limitations concerning applying the electric current within a frequency range of about 4 kHz to 100 kHz via the central conductive surface pad (see the teachings of Romero-Ortega above).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the device suggested by Shah in view of Shah-130 to apply an electric current within a frequency ranged between about 4 kHz to 100 kHz via the central conductive surface pad, as further suggested by Romero-Ortega. The advantage of such modification may improve the regeneration of the nerve during the electrical stimulation (see paragraphs [0126, 0217, 0235] by Romero-Ortega).
10. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shah et al.
Regarding claim 9, Shah teaches the device according to claim 1, wherein the at least two electrodes are arranged on the inner surface of the substrate (the inner surface of thin-film neural interface 160 may include a plurality of electrodes 165 using various shapes and patterns to form certain types of interfaces (e.g., spiral cuff electrodes, epidural electrodes, linear electrodes, and intraneural electrodes) [0067]. For example, the thin-film neural interface 160 may include cuff electrodes and/or linear electrodes which are considered to be surface electrodes which contact the outer surface of the nerve to establish an electrical connection [0064, 0067]. Meanwhile, the thin-film neural interface 160 may also include intraneural electrodes (e.g. needle or spike electrodes) which are known to penetrate the outer surface of the nerve to establish an electrical connection within the nerve [0064, 0067]).
Shah does not explicitly teach wherein each of the at least two electrodes are arranged opposite to each other in a longitudinal direction of the substrate, wherein, when the substrate is placed on the nerve the longitudinal direction of the substrate is substantially parallel to the axis of the nerve, wherein the at least two electrodes are arranged at a predetermined distance from each other, and wherein the predetermined distance is at least 75% of the length of the substrate in the longitudinal direction.
The Examiner respectfully submits, Shah teaches the use of electrodes arranged on the inner surface of the substrate (see the explanation above), configuring the exact arrangement of the electrodes on the substrate (e.g., distance between electrodes) and the longitudinal direction of the substrate to be parallel when placed on the nerve would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
11. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. in view of Pepin et al. (US 2018/0272126 A1).
Regarding claim 14, Shah teaches the device according to claim 1. Shah does not explicitly teach wherein the substrate comprises at least one tightening strip so that when the substrate is placed on the nerve, the tightening strip is configured to tighten the grip of the substrate around the nerve.
The prior art by Pepin is analogous to Shah, as they both teach an electrode cuff that is configured to contact a nerve ([abstract]).
Pepin teaches wherein the substrate comprises at least one tightening strip so that when the substrate is placed on the nerve, the tightening strip is configured to tighten the grip of the substrate around the nerve (the clamp is configured tighten the grip of the substrate of the electrode cuff around the nerve [0054, 0126]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Shah’s substrate to include a tightening strip that is configured to tighten the grip of the substrate around the nerve, as taught by Pepin. The advantage of such modification will improve the engagement of the electrodes into the nerve (see paragraphs [0047, 0054, 0126 by Pepin).
Allowable Subject Matter
12. Claim 10-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided a description below which demonstrates how the prior art of record fails to suggest the corresponding claims.
Regarding claim 10, Shah teaches the device according to claim 1. Shah does not explicitly teach wherein the substrate comprises at least two structures comprising a gap therebetween, wherein the at least two structures are directed substantially parallel to a longitudinal direction of the substrate, so that when the substrate is placed on the nerve, the longitudinal direction of the substrate is substantially parallel to the axis of the nerve, and wherein the gap facilitates a bendability of the substrate when the substrate is arranged at least partially surrounding the nerve.
However, Pepin teaches wherein the substrate comprises at least two structures comprising a gap therebetween (the electrode cuff 404 comprises a substrate 428 including one or more electrode protrusions 418 [0088]. Specifically, figure 4 illustrates a gap between the electrode protrusions 418 of the substrate 428 [0088, FIG. 4]), and wherein the gap facilitates a bendability of the substrate when the substrate is arranged at least partially surrounding the nerve (the gap allows the substrate 428 to be flexed open to accept a nerve during implantation [0088]).
Pepin does not explicitly teach wherein the at least two structures are directed substantially parallel to a longitudinal direction of the substrate, so that when the substrate is placed on the nerve, the longitudinal direction of the substrate is substantially parallel to the axis of the nerve.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 11-12 are considered to contain allowable subject matter, as claims 11-12 depend upon claim 10.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. The Examiner respectfully submits that the prior art by Schmidt (US 2018/0117313 A1) is pertinent to Applicant’s disclosure, as Schmidt teaches a substrate that is a nerve cuff ([0010, 0020, 0041, 0080]).
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair- my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 272-1000.
/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
Prosecution Insights