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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/386,731 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the differences would have been obvious to one of ordinary skill in the art. For example, while the application claim 1 recites, a hollow needle “configured to pierce a user’s skin” and the copending claim 1 only recites a hollow needle, it would have been obvious to one of ordinary skill in the art that the copending application’s hollow needle would be capable of piercing a user’s skin. While the application claim 1 recites, a controller… “configured to provide stimulation parameters to the stimulator to control the electrical signal” and the copending claim 1 only recites the controller... “configured to control the electrical signal”, a POSITA would understand stimulation parameters would necessarily be provided to the stimulator. These are exemplary examples but other differences would have been equally obvious to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, “a feedback sensor configured to be secured to the user’s skin and to provide stimulation information associated with activity of a muscle associated with a target nerve”. However the remainder of the claim does not associate the system to the target nerve. For instance, while stimulation parameters are provided to control an electrical signal to the first conductive surface of a hollow needle to provide a directional electrical field around the needle, claim 1 does not state this directional electrical field is delivered to the target nerve. The claim is indefinite because it is unclear where the needle is being positioned and if the stimulation information received from the feedback sensor is a result of the directional electrical field delivered to the target nerve, or delivered to another tissue that somehow then affects the target nerve.
Claim 14 recites the limitation "the high frequency bi-polar exponentially decaying waveform" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "at least one of the EEG information, brain stem response information, compound action potentials, nociceptive reflex information, EMG information and pupillometry information" in lines 1-3. There is antecedent basis for referencing the EEG information (since claim 17 introduces the EEG information), but there is insufficient antecedent basis for referencing the “brain stem response information, compound action potentials, nociceptive reflex information, EMG information and pupillometry information" in the claim as this limitation has not yet been properly introduced.
Claims 2-22 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
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) 1-3, 7, 9-10, 12, 16, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389).
Regarding claim 1, Jiang et al. discloses a system for positioning a needle comprises: a needle (“foramen needle”) configured to pierce a user’s skin and including at least a first conductive surface adjacent to a point of the needle (“a foramen needle includes a discrete electrode” [0096]); a stimulator (“EPG”) electrically connected to the first conductive surface and configured to provide an electrical signal to the first conductive surface ([0095]); a feedback sensor (“EMG electrodes”) configured to be secured to the user’s skin and to provide stimulation information associated with activity of a muscle associated with a target nerve ([0093], [0096-0097]); a controller 60 operably connected to the stimulator and the feedback sensor and configured to: provide stimulation parameters to the stimulator to control the electrical signal provided to the first conductive surface to provide a directional electrical field around the needle (“The user may increase the stimulation level in desired increments or the system may automatically increase the stimulation until the EMG response is recorded.” [0096]), receive stimulation information from the feedback sensor ([0096-0097]); and generate image information associated with a position of the needle in the user’s body based on the stimulation parameters and stimulation information (fig. 9E-G).
Jiang et al. does not expressly disclose the needle is a hollow needle. Stylos et al. teaches an analogous system where are needle is placed adjacent to and electrically stimulates a target nerve ([0061]) to determine if the target nerve is optimal for implanting a percutaneous nerve ([0062]). Stylos et al. teaches the needle may be hollow needles with inner diameters sufficiently large to accept percutaneous leads ([0062]). Given Jiang et al. is also concerned with advancing a lead to a target nerve located by a needle ([0099]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. to use a hollow needle as taught by Stylos et al., in order to assist in the implantation of the neurostimulation lead after the target nerve has been determined by the needle, the results of such a modification being reasonably predictable.
Regarding claim 2, Jiang et al. discloses a display element 61 operably connected to the controller ([0097]) and operable to receive the image information and provide an image of the needle in the user’s body ([0098]; fig. 9G).
Regarding claim 3, Jiang et al. discloses wherein the controller 60 comprises: a processor (“microprocessor”); and a memory operably connected to the processor and including processor executable code (“specialized computer-code instructions” [0064]), that when executed by the processor: generates the stimulation parameters based at least on the stimulation information ([0064]; [0096]); and generates the image information based at last on the stimulation parameters and the stimulation information ([0097]).
Regarding claim 7, Jiang et al. discloses wherein the stimulation parameters and stimulation information are provided to the display element and illustrated on the display element (fig. 9G).
Regarding claim 9, Jiang et al. discloses wherein the display element is a touch screen configured to enter information associated with the stimulation parameters ([0010]).
Regarding claim 10, Jiang et al. discloses an input element (“EPG”) configured to receive the stimulation parameters (fig. 9A; [0062]).
Regarding claim 12, Jiang et al. in view of Stylos et al. discloses a lead (“percutaneous leads 18 and 20” [0062]) mounted in the needle with a distal end of the lead extending beyond the hollow needle, the distal end including a conductive portion electrically connected to the stimulator (“the proximal ends of leads 18 and/or 20 are operably connected to EPG 12” [0063]), wherein the stimulator provides a pain relieving waveform to the conductive portion of the catheter for application to the target nerve ([0064]). While the claim recites a catheter instead of a lead, no other structural limitations differentiating a catheter from a lead are currently recited, therefore one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that a catheter could be substituted with a lead, as they are both implanted elongated structures similar enough in the art.
Regarding claim 16, Jiang et al. discloses wherein the stimulation information indicates effectiveness of the pain relieving waveform based on activity of the muscle associated with the target nerve ([0061]).
Regarding claim 19, Jiang et al. discloses wherein the controller is operably connected to a user device (“clinician programmer” [0062]) associated with the user, wherein the user device provides control information to the controller to control the stimulator to provide the pain relieving waveform (fig. 1, 9A).
Regarding claim 20, Jiang et al. discloses wherein the user device is connected to the controller via a wired connection (fig. 7).
Regarding claim 21, Jiang et al. discloses wherein the user device is connected to the controller via a wireless connection ([0062]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of Wang et al. (US 2011/0319758).
Regarding claim 4, Jiang et al. does not expressly disclose the image information includes distance information and direction information associated with the needle and the target nerve. Wang et al. teaches enhancing the process of implanting a needle into a user’s body by utilizing an ultrasound to provide accurate placement of a needle tip in a specific target position ([0005]). Using ultrasound to provide image information during the placement of the needle allows for visualization of the needle position, needle path tip, and interaction with the tissue in real time ([0030]), thus providing distance information and distance information associated with the needle and the target tissue. It would have been obvious to one of ordinary skill in the art to modify Jiang et al. and utilize ultrasound imaging to provide distance information and direction information associated with the needle and the target nerve as taught by Wang et al. in order to further enhance the process of implanting the needle into the user’s body, the results of such a modification being reasonably predictable in the art.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of King et al. (US 2020/0368532).
Regarding claim 8, Jiang et al. does not expressly disclose wherein the display element of the clinician programmer 60 is one of a liquid crystal display, a cathode ray tube display, light emitting diode display and a plasma display, but King et al. teaches clinician programmers can comprise liquid crystal display (LCD) or light emitting diode (LED) displays ([0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. to select an LCD or an LED display as the clinician programmer as taught by King et al. as it is a known display type for such devices, the results of such a modification being reasonably predictable.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of Hochman et al. (US 2021/0290843).
Regarding claim 11, Jiang et al. does not expressly disclose wherein the hollow needle is configured to provide a pharmaceutical anesthesia to the target nerve. Hochman et al. teaches providing a fluid anesthetic solution through a hollow needle ([0030], [0088]) during nerve stimulation ([0082], [0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. to configure the hollow needle to provide a pharmaceutical anesthesia to the target nerve as taught by Hochman et al. in order to increase the impedance so that electrical current charge can more effectively be dispersed through the tissues at a smaller voltage so that the stimulating current is less painful ([0017]) and since it is a known technique in the art, the results of such a modification being reasonably predictable.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of Birkill et al. (US 2012/0143281).
Regarding claim 13, Jiang et al. does not expressly disclose wherein the pain relieving waveform includes a low frequency square wave with a high frequency bi-polar exponentially decaying waveform superimposed thereon. Birkill et al. teaches it is known in the art for a pain relieving waveform to comprise a low frequency square wave with a high frequency bi-polar exponentially decaying waveform superimposed thereon ([0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. to try delivering a pain relieving waveform comprising a low frequency square wave with a high frequency bi-polar exponentially decaying waveform superimposed thereon as taught by Birkill et al. as it is a known waveform in the art for treating pain, the results of such a modification being reasonably predictable.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of Prebeg et al. (US 2022/0096857).
Regarding claim 14, Jiang et al. does not expressly disclose wherein the high frequency bi-polar exponentially decaying waveform has a frequency of about 133 kHz. Prebeg et al. teaches that a pain relieving waveform of an exponential decay is known to have a frequency from 20 kHz to 350 kHz ([0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. to try delivering a pain relieving waveform comprising a a bi-polar exponentially decaying waveform with a frequency of about 133 kHz as taught by Prebeg et al. as it is a known waveform in the art for treating pain, the results of such a modification being reasonably predictable.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of Gross (US 2015/0245867).
Regarding claim 15, Jiang et al. does not expressly disclose wherein the pain relieving waveform includes a radio frequency component between 50kHz and 500kHz of varying or non-varying amplitude. Gross teaches providing electrical current to nerve tissue ([0029]) and additionally applying ablative current to the nerve tissue ([0030]) at a radio frequency component between 50kHz and 500kHz (“apply a radio-frequency current having a frequency of between 5 kHz and 1 GHz” [0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. and try applying a radio frequency component of between 50kHz and 500kHz as part of the pain relieving waveform as taught by Gross as it is a known technique in the art, the results of such a modification being reasonably predictable.
Claim(s) 17-18, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2016/0045746) in view of Stylos et al. (US 2022/0088389) and further in view of Annoni et al. (US 2020/0238087).
Regarding claims 17-18, Jiang et al. does not expressly disclose a plurality of EEG electrodes configured for attaching to a user’s head and configured to provide EEG information indicating brain activity associated with pain of a user; wherein the stimulation parameters are set based on the EEG information. Annoni et al. teaches that evaluating the pain of a user can be achieved from a plurality of EEG electrodes ([0087]) that are configured for attaching to a user’s head ([0044]), this EEG information combined with delivery of neurostimulation energy to a nerve ([0093]), specifically the EEG ingormation can be used for closed-loop control of a pain therapy ([0008], [0090]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jiang et al. to include a plurality of EEG electrodes configured for attaching to a user’s head and configured to provide EEG information indicating brain activity associated with pain of a user, wherein the stimulation parameters are set based on the EEG information as taught by Annoni et al. in order to provide an objective measurement assessment of a user’s pain, and to provide closed-loop pain therapy, the results of such a modification being reasonably predictable.
Regarding claim 22, Jiang et al. disclose wherein EMG information is provided to the display element and illustrated on the display element (fig. 9G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
