CTNF 18/753,812 CTNF 101525 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim s 1 & 15 are objected to because of the following informalities: claim 1, in line 12, & claim 15, in line 13 - "electrodes_based" typographical error . Appropriate correction is required. 07-29-01 AIA Claim s 1 & 15 are objected to because of the following informalities: claim 1 in line 5 & claim 15 in line 6 - "control a stimulation circuitry" for consistency and clarity of record . Appropriate correction is required. 07-30-03-h AIA Claim Interpretation Regarding claim 1, in lines 1-2, & claim 15, in lines 2-3, examiner interprets patient implanted with electrode leads as part of the preamble for intended use, thereby requiring the electrode leads to only be capable of implantation not necessitated as claimed. Regarding claim 1 claim 1 in line 5 & claim 15 in line 6, examiner interprets “control stimulation circuitry” to mean “control a stimulation circuitry” whereby a stimulation circuitry is controlled by the system herein. Double Patenting 08-33 AIA 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. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1 & 15 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 & 6 of U.S. Patent No. 10912944. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader than the patent claims in at least one aspect. Regarding claim 1, the following table compares application claim 1 to patent claims 1 & 6. Instant Application 18753812 US Patent 10912944 Claim 1 : A system for providing electrical stimulation to a patient wherein the patient is implanted with one or more spinal electrode leads within the patient’s spinal column and comprising a plurality of spinal electrodes, the system comprising: Claim 1 : A method of determining a physiological midline of a patient, the method comprising: control circuitry configured to: control stimulation circuitry to provide a first electrical stimulation at a first one or more peripheral electrodes positioned at a first location of the patient other than the patient’s spinal column, providing electrical stimulation at a first one or more peripheral electrodes positioned on a first side the patient's anatomical midline and at a second one or more peripheral electrodes positioned on a second side of the patient's anatomical midline; receive data from the one or more leads that is indicative of a first action potential evoked by the first electrical stimulation at one or more of the plurality of spinal electrodes, and receiving data indicative of a response at one or more spinal electrodes to the electrical stimulation provided at the first and second one or more peripheral electrodes ; and calculating, based on the received data, a measure of each of the one or more spinal electrodes' position with respect to the patient's physiological midline. determine at least one stimulation parameter to be applied using one or more of the spinal electrodes based on the first action potential. Claim 6 : The method of claim 5, wherein providing further stimulation at the first and second one or more peripheral electrodes comprises increasing an amplitude of the stimulation provided at the first and second one or more peripheral electrodes . Patent claims 1 & 6 further limits and/or includes additional elements which encompass application claims 1 & 15. Therefore, patent claims 1 & 6 anticipate application claims 1 & 15. Following the rationale in In re Goodman , cited above, where applicant has been granted a patent containing a claim for the specific or narrower invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-18 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 to significantly more than the judicial exception. Under Step (1): Independent claims 1 and 15 are directed to a system, and thus, the claims all fall under one of the four patent eligible categories. Under Step 2(a) prong 1: Independent claims 1 & 15 recite limitations of: control stimulation circuitry to provide a first electrical stimulation at a first one or more peripheral electrodes positioned at a first location of the patient other than the patient’s spinal column, receive data from the one or more leads that is indicative of a first action potential evoked by the first electrical stimulation at one or more of the plurality of spinal electrodes, and determine at least one stimulation parameter to be applied using one or more of the spinal electrodes based on the first action potential. Under broadest reasonable interpretation, these limitations appear to be directed toward mental processes because control circuitry concerns providing, receiving, and selecting signal data based on comparisons and/or evaluations which can be performed in the mind or with pen a paper. Electrodes and leads for providing electrical stimulation are not positively claimed. Examiner interprets control circuitry to pass and receive, stored and/or reprogrammed, signal data to and from stimulation device, respectively. For example, a person can identify evoked signals by observing and comparing signal data, then select additional stimulation parameter values through observation and judgement. Accordingly, claims 1 & 15 are directed to a judicial exception including one or more abstract ideas under mental processes. Dependent claims 2 & 16, recite additional limitations of “provide a second electrical stimulation at a second one or more peripheral electrodes positioned at a second location” and “receive data from the one or more leads indicative of a second action potential evoked by the second electrical stimulation at the one or more of the plurality of spinal leads” but do not further limit the control circuit in any reasonable way, because the first and second locations are locations of electrodes that are not positively claimed, therefore they are not part of the claimed control circuit. Dependent claims 3-4, 17-18 recite additional limitations of “determine a ratio of the first and second recorded action potentials” and “determine a measure of the one or more spinal electrodes’ position with respect to a physiological midline of the patient based on the ratio” but appear to be directed toward mental processes because they concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claims 8-9, recite additional limitations of “determine a measure of correlation of each of the more than one of the spinal electrodes” and “use the determined measure of correlation to determine the at least one stimulation parameter” but appear to be directed toward mental processes because they concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claim 10, recites an additional limitation of “use the data indicative of the first and second action potentials to calculate a position of the patient’s physiological midline” but appears to be directed toward mental processes because it concerns observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claims 5, 6, 15, 16, recite additional limitations of “first and second locations are on opposite sides of the patient’s anatomical midline” and “first and second locations are on the same side of the patient’s anatomical midline” but do not further limit the control circuit in any reasonable way, because the first and second locations are locations of electrodes that are not positively claimed, therefore they are not part of the claimed control circuit. Dependent claims 11-13, recite additional limitations of “display an indication of the patient’s physiological midline”, “indication of the patient's physiological midline is displayed with respect to a fluoroscopic image”, and “display an indication of the spinal electrodes with respect to the patient’s physiological midline” but appear to be directed toward mental processes because they concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claim 14, recites an additional limitation of “the first action potential is an evoked compound action potential (ECAP)” but appears to be directed toward mental processes because it further limits an abstract idea. Under Step 2(a) 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). Claims 1 & 15 include an additional element of stimulation circuitry and recite limitations of “control stimulation circuitry to provide a first electrical stimulation” and “receive data from the one or more leads that is indicative of a first action potential evoked.” These limitations appear to be directed toward insignificant pre-solution activity while the stimulation circuitry only generally links the abstract idea to another technology or field of use. Furthermore, these claims recite an additional element of “control circuitry” but do not improve upon a technology or technical field and appears to implement abstract ideas using generic computer components and/or link these judicial exceptions to a field of use. Claims 2 & 16 recite limitations of “provide a second electrical stimulation” and “receive data from the one or more leads indicative of a second action potential evoked” and appear to be directed toward insignificant pre-solution activity. Claim 11 recites an additional element of “display” but does not improve upon a technology or technical field and appears to implement abstract ideas using a generic computer and/or components. Claims 11-13 recite limitations of “to display” and “is displayed” and appear to output data using a generic computer component and are directed to post-solution activity. Claims 15-18 recite additional elements of “non-transitory computer-readable medium” and “instructions” but do not improve upon a technology or technical field and appears to implement abstract ideas using a generic computer and/or components. Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). See MPEP 2106.04(a)(2)(III). Furthermore, generic computer components that perform abstract ideas are still abstract mental processes unless the claim limitation cannot be practically performed in the mind. As such, “control circuitry”, “stimulation circuitry”, “display”, and “non-transitory computer-readable medium” appear to amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Under Step 2b: The claims also do not include additional elements that are sufficient to 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 “control circuitry”, “stimulation circuitry”, “display”, and “non-transitory computer-readable medium” are well-understood, routine, and conventional activities previously known in the field of electrostimulation as indicated in the applicant’s published disclosure whereby stimulation circuitry is recited to include application specific integrated circuits (ASIC, 36, Fig. 2) [0005] and control circuitry is recited to include microprocessors, microcomputers, and FPGAs [0018] and the following references: US 2004/0138716 A1: See [0032] microcontroller (at least RAM/ROM or memory) for control circuitry and non-transitory computer-readable medium. US 2003/0153953 A1: See [0079] timing control circuitry (479, integrated with processor (460), Fig. 4) for stimulation circuitry. US 2012/0265268 A1: See [0100] for display. US 2013/0245719 A1: See [0015] user interface for display. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15-aia AIA Claim(s) 1-2, 6-9, 14-16 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zhu et al (US Pre Grant Publication 2013/0245719 A1) . Regarding claims 1 & 15, Zhu teaches a system for providing electrical stimulation (10, Fig. 1) to a patient wherein the patient (46) is implanted with one or more spinal electrode leads (12a and or 12b, Fig. 3) within the patient’s spinal column and comprising a plurality of spinal electrodes (26, Fig. 1), the system comprising [0038]: control circuitry (at least one of ETS (20) or CP (18)) configured to: control stimulation circuitry to provide a first electrical stimulation at a first one or more peripheral electrodes (12b, Fig. 3) positioned at a first location of the patient other than the patient’s spinal column ([0040], [0042], [0050]); leads (12) connected to one of ETS (20) or CP (18); for peripheral nerve field stimulation, leads (12b) are implanted in the lower back. receive data from the one or more leads that is indicative of a first action potential evoked by the first electrical stimulation at one or more of the plurality of spinal electrodes ([0052-0056]; “In the illustrated embodiment, the electrical measurements taken by the monitoring circuitry 60 for the purpose of determining the location and/or depth of each stimulation lead 12 are electrical impedances, although other suitable measurements, such as, e.g., electrical field potentials or evoked potential measurements, can be obtained.”) and determine at least one stimulation parameter to be applied using one or more of the spinal electrodes based on the first action potential ([0071-0072]; “In any event, the CP 18 may actively control the characteristics of the electrical stimulation generated by the IPG 14 to allow the optimum stimulation parameters to be determined based on patient response and feedback and for subsequently programming the IPG 14 with the optimum stimulation parameters.”; patient response includes evoked potential measurements as recited in [0056].) Regarding claims 2 & 16, Zhu teaches the system of claim 1 & 15, wherein the control circuitry (Fig.1; at least one of ETS (20) or CP (18) and telemetry circuitry (118)) is configured to control the stimulation circuitry (IPG (14)) to provide a second electrical stimulation [0071] at a second one or more peripheral electrodes (12b, Fig. 3, peripheral lead and/or electrodes not selected for first location) positioned at a second location of the patient other than the patient’s spinal column ([0040], [0042], [0050]; second electrical stimulation of electrodes (12b, electrode set at second location and not subject to first electrical stimulation)); and to receive data from the one or more leads indicative of a second action potential evoked by the second electrical stimulation at the one or more of the plurality of spinal leads ([0056]; evoked potential measurements can be obtained through any combination of stimulation leads (12) and electrodes (26) including same lead electrodes and surface electrodes.) PNG media_image1.png 583 284 media_image1.png Greyscale Regarding claim 6, Zhu teaches the system of claim 2, and further teaches a system wherein the first and second locations are on the same side of the patient’s anatomical midline ([0056], Fig. 3); superior lateral peripheral lead (12b) and inferior lateral peripheral lead (12b) are first and second locations located on the same side of the midline. PNG media_image1.png 583 284 media_image1.png Greyscale Regarding claim 7, Zhu teaches the system of claim 1, and further teaches a system wherein the control circuitry is configured to receive data from the one or more electrode leads indicative of action potentials at more than one of the spinal electrodes evoked by stimulation at the first one or more peripheral electrodes positioned at the first location of the patient [0056-0060]; “While a selected one of the electrodes 26 is activated to generate the electrical field, a selected one or ones of the electrodes 26 (different from the activated electrode) is operated to record a measurable deviation in the voltage caused by the evoked potential due to the stimulation pulse at the stimulating electrode.” Regarding claim 8, Zhu teaches the system of claim 7, wherein the control circuitry is configured to determine a measure of correlation of each of the more than one of the spinal electrodes to the first location of the patient ([0056], [0078-0081], [0058-0059]); examiner notes, under BRI, measure of correlation is interpreted to include impedance vectors calculated from interelectrode voltage or impedance measurements; impedance vectors can be measured from any lead with at least two electrodes or at least two distinct leads with at least one electrode; therefore, impedance vectors correlate measurements to location. Regarding claim 9, Zhu teaches the system of claim 8, and further teaches a system wherein the control circuitry is configured to use the determined measure of correlation to determine the at least one stimulation parameter [0080]. “Thus, if the measured electrical parameter data indicates a tissue impedance of a few hundred ohms, the implantation site of the stimulation lead configuration may be determined to be in the epidural space, thereby requiring a stimulation regimen conducive to SCS therapy.” Regarding claim 14, Zhu teaches the system of claim 1, and further teaches a system wherein the first action potential is an evoked compound action potential (ECAP) ([0056], [0059-0060]); “The evoked potential measurement technique may be performed by generating an electrical field at one of the electrodes 26, which is strong enough to depolarize the neurons adjacent the stimulating electrode beyond a threshold level, thereby inducing the firing of action potentials (APs) that propagate along the neural fibers.” Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 3, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al (US Pre Grant Publication 2013/0245719 A1) , in view of Parker et al (US Pre Grant Publication 2014/0236257 A1) . Regarding claims 3 & 17, Zhu teaches the system of claims 2 & 16, and further teaches a system wherein the control circuitry is configured to determine a ratio between electrodes on the same lead ([0056], [0058], [0059]; “For example, a known current can be applied between a pair of electrodes 26, a voltage between the electrodes 26 can be measured, and an impedance between the electrodes 26 can be calculated as a ratio of the measured voltage to known current.”); Zhu does not teach a system wherein the control circuitry is configured to determine a ratio of the first and second recorded action potentials as claimed. However, Parker teaches a system wherein the control circuitry is configured to determine a measurement between the first and second recorded action potentials ([0039], Fig. 12; electrode-to-fiber distance can be estimated by measuring neural response amplitudes or evoked responses at different locations). 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 system of Zhu with the system to determine a measurement between the first and second recorded action potentials as taught by Parker. One of ordinary skill in the art would have been motivated to make these modifications to minimize unwanted neural recruitment by aligning electrodes to preferred locations (Parker, [0039]) . 07-21-aia AIA Claim (s) 4, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al (US Pre Grant Publication 2013/0245719 A1) , in view of Parker et al (US Pre Grant Publication 2014/0236257 A1) , and in further view of Holley (US Pre Grant Publication 2015/0127062 A1 . Regarding claims 4 & 18, Zhu & Parker teach the system of claims 3 & 17, but do not disclose a system wherein the control circuitry is configured to determine a measure of the one or more spinal electrodes’ position with respect to a physiological midline of the patient based on the ratio as claimed. However, Holley teaches a system (at least CP 18, Fig. 2) to calculate a position of the patient’s physiological midline [0068-0069]; 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 system of Zhu & Parker with the system to calculate a position of the patient’s physiological midline as taught by Holley. One of ordinary skill in the art would have been motivated to make these modifications to improve accuracy of lead placement and thereby treatment efficacy by determining the patients’ physiological midline (Holley, [0011], [0015]) . 07-21-aia AIA Claim (s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al (US Pre Grant Publication 2013/0245719 A1) . Regarding claim 5, Zhu teaches the system of claim 2, but does not disclose a system wherein the first and second locations are on opposite sides of the patient’s anatomical midline as claimed. However, Zhu further teaches, at least in an embodiment without lead extensions (24) connected to the IPG (14) and leads (12) implanted in the lower back ([0051], Fig. 1), a system wherein the first and second locations are on opposite sides of the patient’s anatomical midline; at least one of superior lateral peripheral lead (12b) or inferior lateral peripheral lead (12b) without lead extension would cause first and second locations to be on opposite sides of the midline. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Zhu with the system without at least one lead extension connected to at least one lower back lead as taught by Zhu. One of ordinary skill in the art would have been motivated to make these modifications to allow electrode measurements closer to the IPG by connecting leads directly to the IPG [0051] . 07-21-aia AIA Claim (s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al (US Pre Grant Publication 2013/0245719 A1) , in view of Holley (US Pre Grant Publication 2015/0127062 A1) . Regarding claim 10, Zhu teaches the system of claim 2, and further teaches a system wherein the control circuitry is configured to use the data indicative of the first and second action potentials to calculate a position ([0056], [0078-0081], Fig. 3). Zhu does not disclose a system to calculate a position of the patient’s physiological midline as claimed. However, Holley teaches a system (at least CP 18, Fig. 2) to calculate a position of the patient’s physiological midline [0068-0069]; 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 system of Zhu with the system to calculate a position of the patient’s physiological midline as taught by Holley. One of ordinary skill in the art would have been motivated to make these modifications to improve accuracy of lead placement and thereby treatment efficacy by determining the patients’ physiological midline (Holley, [0011], [0015]) . 07-21-aia AIA Claim (s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al (US Pre Grant Publication 2013/0245719 A1) , in view of Holley (US Pre Grant Publication 2015/0127062 A1) , and in further view of Blum et al (US Pre Grant Publication 2012/0265268 A1) . Regarding claim 11, Zhu and Holley teach the system of claim 10, and Holley further teaches a system wherein the system (CP 18, Fig. 2) further comprises a display [0053]. Zhu and Holley do not disclose wherein the control circuitry is configured to display an indication of the patient’s physiological midline. However, Blum teaches a system [0099-0102] wherein the system further comprises a display and wherein the control circuitry [0100] is configured to display an indication of the patient’s physiological midline (78, Fig. 8B) ([0079-0080], Fig. 8B & 9); “The tool determines the functional midline for the one or more electrodes and may display on a display screen, an image of a spinal cord and the one or more electrodes such that the functional midline of the one or more electrodes is aligned to the physiologic midline of the spinal cord.”; aligning functional midline of electrodes to physiological midline of patient necessitates displaying physiological midline. 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 system of Zhu and Holley with the system wherein the system further comprises a display and wherein the control circuitry is configured to display an indication of the patient’s physiological midline as taught by Blum. One of ordinary skill in the art would have been motivated to make these modifications to improve accuracy of lead placement and thereby treatment efficacy by determining the patients’ physiological midline (Holley, [0011], [0015]). Regarding claim 12, Blum teaches the modified system of claim 11, and further teaches a system wherein the indication of the patient's physiological midline (78, Fig. 8B) is displayed with respect to a fluoroscopic image ([0079-0080], Fig. 8B & 9); [0047] “The radiologic image may be any type of body imaging used in medicine, such as x-rays (including conventional film and fluoroscopic x-rays), magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), etc.” It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Blum with the system wherein the indication of the patient's physiological midline is displayed with respect to a fluoroscopic image as taught by Blum. One of ordinary skill in the art would have been motivated to make these modifications to improve accuracy of lead placement and thereby treatment efficacy by determining the patients’ physiological midline (Holley, [0011], [0015]). Regarding claim 13, Blum teaches the modified system of claim 11, and further teaches a system wherein the control circuitry is configured to display an indication of the spinal electrodes (50 and/or 51; at least one electrode from each lead or at least two electrodes from one lead, Fig. 8B) with respect to the patient’s physiological midline (78, Fig. 8B) ([0079-0080], Fig. 8B & 9). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Blum with the system wherein the control circuitry is configured to display an indication of the spinal electrodes with respect to the patient’s physiological midline as taught by Blum. One of ordinary skill in the art would have been motivated to make these modifications to improve accuracy of lead placement and thereby treatment efficacy by determining the patients’ physiological midline (Holley, [0011], [0015]) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baynham et al (US Pre Grant Publication 2015/0032181 A1) discloses a spinal cord stimulation system that measures eCAPs for field potential measurements and additional morphological analysis. Although Baynham discloses peripheral nerve stimulators, peripheral electrodes for midline estimation are not disclosed. 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. 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DWANE COLLARD/Examiner, Art Unit 3792 /William J Levicky/ Primary Examiner, Art Unit 3796 Application/Control Number: 18/753,812 Page 2 Art Unit: 3792
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