CTFR 18/002,119 CTFR 98754 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. Response to Arguments 07-38-02 AIA Applicant’s arguments, see pages 9-11 , filed on 03/27/2026 , with respect to the rejection(s) of claim(s) 1, 9, and 15 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Saab (US 2013/0066394) . 07-30-03-h AIA Claim Interpretation Regarding claims 1, 9, and 15 Examiner notes the limitation “…identify a corrective electrical stimulation signal that, when delivered by the one or more stimulating electrodes to peripheral nerves, reduces pathological neuronal events while preserving acute pain response” is a contingent limitation. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04(II)). Therefore, Examiner will be interpreting claim 9 as not requiring the step of “…identify a corrective electrical stimulation signal that, when delivered by the one or more stimulating electrodes to peripheral nerves, reduces pathological neuronal events while preserving acute pain response” under the broadest reasonable interpretation. Examiner notes the system claims 1 and 15 only require the structure that performs the function of the contingent step along with the other recited claim limitations. Claim Objections Claim 4 is objected to because of the following informalities: Claim 4, line 3 recites “…the-peripheral nerves…”. Examiner suggests amending the claim to include a space between each word. Appropriate correction is respectfully requested. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 23-25 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 23 recites the limitation "the trained healthy computer model" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending claim 23 to depend from claim 20 in order to correct the lack of antecedent basis. Claim 24 recites the limitation "the trained healthy computer model" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending claim 24 to depend from claim 21 in order to correct the lack of antecedent basis. Claim 25 recites the limitation "the trained healthy computer model" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending claim 25 to depend from claim 22 in order to correct the lack of antecedent basis 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. 07-21-aia AIA Claim (s) 1, 4-7, 9, 12-13, 15, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Saab (US 2013/0066394) in view of Thakur et al (US 2020/0188673) hereinafter Thakur . Regarding claim 1, Saab discloses a closed-loop implantable neurostimulator system for mitigating chronic pain (Fig. 2A), the closed-loop implantable neurostimulator system comprising: a neuromodulation device ([0086] DBS system 5) configured to be implanted in a user comprising one or more recording electrodes ([0077] measure electrical activity in the brain using implanted electrodes) configured to measure a physiological signal at a ventral posterolateral nucleus of a thalamus of a subject ([0087] electrical lead 40 can be configured to measure electrical activity of the patient 10 in other areas (e.g., the VPL)) and deliver an electrical stimulation signal to the subject using one or more stimulating electrodes ([0090] electrical signal to be provided to the brain of the patient 10 via an electrical lead 45); and a controller ([0086] processor 20), in communication with the one or more recording electrodes and the one or more stimulating electrodes (Fig. 2A shows processor 20 in communication with leads 40 and 45), the controller configured to analyze the physiological signal that is measured by comparing the physiological signal to a healthy physiological signal to identify a corrective electrical stimulation signal that, when delivered by the one or more stimulating electrodes to the peripheral nerves, reduces pathological neuronal events in the peripheral nerves while preserving acute pain response ([0090] processor 20 can differentiate between multiple recognized patterns, and determine an appropriate response strategy which can cause an electrical signal to be provided to the brain of the patient; Examiner notes that by recognizing patterns (healthy vs abnormal patterns) and determining a response including delivering electrical stimulation, the controller disclosed by Saab satisfies the claim language. The reduction of neuronal events and preservation of acute pain responses are directed towards an intended use of the system). While Saab fails to expressly disclose delivering an electrical stimulation signal to peripheral nerves in the subject using one or more stimulating electrodes, Saab does disclose treating pain-related LFP with peripheral nerve stimulation [0162]. Therefore, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the DBS system as taught by Saab to deliver an electrical stimulation signal to peripheral nerves in the subject using one or more stimulating electrodes in order to reverse pain-related LFP [0162]. Saab further fails to expressly disclose the controller being configured to be implanted in the user. However, Thakur discloses a controller configured to be implanted in the user [0050]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Saab with a controller configured to be implanted in the user as taught by Thakur. Such a modification would provide the predictable results of a closed-loop implantable system that would not require the user to manage and maintain an external controller. Regarding claims 4, 12, and 18 the modified Saab discloses the system of claim 1 and the method of claim 9 as discussed above, but fails to disclose wherein the corrective electrical stimulation signal causes at least one of neuronal inhibition in the-peripheral nerves, neuronal excitation in the peripheral nerves, or no induced change to neuronal activity in the peripheral nerves. However, Saab does disclose reversing pain-related LFP with peripheral nerve stimulation ([0162] Pain-related LFP can be reversed by peripheral nerve stimulation (PNS); Examiner notes in order to reverse the pain related LFPs the stimulation would necessarily have to cause neural inhibition or excitation). Therefore, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Saab to deliver an electrical stimulation signal that causes at least one of neuronal inhibition in the-peripheral nerves, neuronal excitation in the peripheral nerves, or no induced change to neuronal activity in the peripheral nerves in order to reverse pain-related LFP [0162]. Regarding claims 5 and 13, Saab discloses a pulse generator that generates the corrective electrical stimulation signal under direction of the controller ([0086] signal generator 25; Fig 2A shows processor 20 in communication with signal generator 25). Saab fails to expressly disclose that the pulse generator is configured to be implanted in the user. However, Thakur discloses a pulse generator being implanted in a user ([0150] implantable neuromodulator 210A contains electrostimulator 213). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Saab with a pulse generator being implanted in a user as taught by Thakur. Such a modification would provide the predictable results of a closed-loop implantable system that would not require the user to manage and maintain an external pulse generator. Regarding claim 6, the modified Saab discloses the system of claim 4 as discussed above, but fails to disclose a power source configured to be implanted in the user that powers the controller and pulse generator. However, Thakur discloses a power source (battery) configured to be implanted in the user that powers the controller and pulse generator ([0043] IND may include a battery). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Saab with a power source configured to be implanted in the user that powers the controller and pulse generator as taught by Thakur. Such a modification would provide the predictable results of a closed-loop implantable system that would not require the user to manage and maintain an external battery. Regarding claim 7, Saab discloses an insulated lead coupling of one or more electrodes to the controller (Fig. 2A shows lead 45 being coupled to the processor 20). Regarding claim 9, Saab discloses a computer-implemented method for controlling an implantable neurostimulator system for mitigating chronic pain, the computer-implemented method comprising: measuring, by using one or more recording electrodes that are configured to be implanted in a user ([0077] measure electrical activity in the brain using implanted electrodes), a physiological signal at a ventral posterolateral nucleus of a thalamus in a subject ([0087] electrical lead 40 can be configured to measure electrical activity of the patient 10 in other areas (e.g., the VPL)); analyzing, using a controller ([0086] processor 20) in communication with the one or more recording electrodes and one or more stimulating electrodes (Fig. 2A shows processor 20 in communication with leads 40 and 45), the physiological signal that is measured to identify a corrective electrical stimulation signal that, when delivered by the one or more stimulating electrodes to peripheral nerves, reduces pathological neuronal events while preserving acute pain response ([0090] processor 20 can differentiate between multiple recognized patterns, and determine an appropriate response strategy which can cause an electrical signal to be provided to the brain of the patient; Examiner notes that by recognizing patterns (healthy vs abnormal patterns) and determining a response including delivering electrical stimulation, the controller disclosed by Saab satisfies the claim language. The reduction of neuronal events and preservation of acute pain responses are directed towards an intended use of the system); and delivering the corrective electrical stimulation signal using the one or more stimulating electrodes based on the physiological signal that is analyzed ([0090] processor 20 can determine an appropriate response strategy which can cause an electrical signal to be provided to the brain of the patient 10 via an electrical lead 45). While Saab fails to expressly disclose delivering the electrical stimulation signal to peripheral nerves in the subject using one or more stimulating electrodes, Saab does disclose treating pain-related LFP with peripheral nerve stimulation [0162]. Therefore, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the DBS system as taught by Saab to deliver an electrical stimulation signal to peripheral nerves in the subject using one or more stimulating electrodes in order to reverse pain-related LFP [0162]. Saab further fails to expressly disclose the controller being configured to be implanted in the user. However, Thakur discloses a controller configured to be implanted in the user [0050]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Saab with a controller configured to be implanted in the user as taught by Thakur. Such a modification would provide the predictable results of a closed-loop implantable system that would not require the user to manage and maintain an external controller. Regarding claim 15, Saab discloses a closed-loop implantable neurostimulator system for mitigating chronic pain, the closed-loop implantable neurostimulator system comprising: a controller ([0086] processor 20), in communication with one or more recording electrodes ([0077] measure electrical activity in the brain using implanted electrodes) and one or more stimulating electrodes (Figure 2A shows processor 20 in communication with leads 40 and 45; [0087] lead 40 can be configured to measure activity; [0090] lead 45 can deliver electrical stimulation), the controller configured to analyze a physiological signal that is measured using the one or more recording electrodes at a ventral posterolateral nucleus of a thalamus to identify a corrective electrical stimulation signal that, when delivered by the one or more stimulating electrodes to peripheral nerves a target area, reduces pathological neuronal events in the peripheral nerves target area while preserving acute pain response ([0090] processor 20 can differentiate between multiple recognized patterns, and determine an appropriate response strategy which can cause an electrical signal to be provided to the brain of the patient; Examiner notes that by recognizing patterns (healthy vs abnormal patterns) and determining a response including delivering electrical stimulation, the controller disclosed by Saab satisfies the claim language. The reduction of neuronal events and preservation of acute pain responses are directed towards an intended use of the system). Saab fails to expressly disclose the controller being configured to be implanted in the user. However, Thakur discloses a controller configured to be implanted in the user [0050]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Saab with a controller configured to be implanted in the user as taught by Thakur. Such a modification would provide the predictable results of a closed-loop implantable system that would not require the user to manage and maintain an external controller. Regarding claim 19, Saab discloses wherein the one or more recording electrodes comprise deep brain stimulation electrodes ([0077] measuring electrical activity using electrodes implanted into a patient's brain). Regarding claims 20-22, Saab discloses wherein the controller is further configured to analyze the physiological signal that is measured using a trained healthy computer model ([0090] processor 20 is configured to differentiate between various patterns that can be recognized by the pattern recognition system 15 and to determine an appropriate response. The processor 20 can differentiate between multiple recognized patterns, and determine an appropriate response strategy using, for example, a look-up table; Examiner notes that the look-up table will have healthy patterns as well as unhealthy patterns) . 07-21-aia AIA Claim (s) 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Saab (US 2013/0066394) in view of Thakur (US 2020/0188673) and further in view of Sarma et al (US 2012/0016436) hereinafter Sarma . Regarding claims 8 and 14, the modified Saab discloses the system of claim 1 and the method of claim 9 as discussed above, but fails to disclose wherein the controller further identifies the corrective electrical stimulation signal by minimizing a difference between a computer model representing the response to stimuli of a pathological dorsal horn and/or VPL Thalamus system and a computer model representing the response to stimuli of a healthy dorsal horn and/or VPL Thalamus system. However, Sarma discloses wherein the controller further identifies the corrective electrical stimulation signal by minimizing a difference between a computer model representing the response to stimuli of a pathological dorsal horn and/or VPL Thalamus system and a computer model representing the response to stimuli of a healthy dorsal horn and/or VPL Thalamus system (Claim 7: the controller is further configured to identify the corrective electrical stimulation signal by minimizing a difference between predicted pathological neuronal activity determined by analyzing the measured physiological parameter with the pathological model and predicted healthy neuronal activity determined by analyzing the measured physiological parameter with the healthy model). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Saab with the controller further identifying the corrective electrical stimulation signal by minimizing a difference between a computer model representing the response to stimuli of a pathological dorsal horn and/or VPL Thalamus system and a computer model representing the response to stimuli of a healthy dorsal horn and/or VPL Thalamus system as taught by Sarma. Such a modification would provide the predictable results of providing more immediate and effective treatment to the patient (Sarma, [0006]). Allowable Subject Matter Examiner notes that claims 23-25 are rejected under 35 USC 112 as discussed above. However, Examiner has not found any prior art that teach or suggest in combination the limitations recited in claims 23-25. Conclusion 07-40 AIA Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). 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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm. 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, Benjamin 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLOW GRACE WELCH/Examiner, Art Unit 3792 /Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/002,119 Page 2 Art Unit: 3792 Application/Control Number: 18/002,119 Page 3 Art Unit: 3792 Application/Control Number: 18/002,119 Page 4 Art Unit: 3792 Application/Control Number: 18/002,119 Page 5 Art Unit: 3792 Application/Control Number: 18/002,119 Page 6 Art Unit: 3792 Application/Control Number: 18/002,119 Page 7 Art Unit: 3792 Application/Control Number: 18/002,119 Page 8 Art Unit: 3792 Application/Control Number: 18/002,119 Page 9 Art Unit: 3792 Application/Control Number: 18/002,119 Page 11 Art Unit: 3792 Application/Control Number: 18/002,119 Page 12 Art Unit: 3792
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