CTNF 18/956,972 CTNF 98977 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. Information Disclosure Statement The information disclosure statements (IDS) submitted on 03/11/2025 and 04/22/2025 are being considered by the examiner. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-20 are currently pending and under examination. Priority The instant application was filed on 11/22/2024 under 35 USC 111(a). Acknowledgment is made of Applicant's claim for domestic priority based on provisional application 63/603,478 (filed on 11/28/2023). Instant claims 1-20 are adequately supported in the provisional application to receive an effective filing date of 11/28/2023. 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 1-20 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. Claims 1 and 19: The use of “the patient” lacks an antecedent basis and renders claims 1 and 19 indefinite. Claim 1 states “A method of operation in a neuromodulation system having an implantable pulse generator including a housing containing operational circuitry configured to deliver therapy to the patient using one or more therapy programs” and claim 19 states “A neuromodulation system comprising an implantable pulse generator including a housing containing operational circuitry having therein a microcontroller and a memory, the memory storing patient data and readable instructions for one or more programs for treating the patient .” Claims 2-9, 14, and 17-18 are directed to a process (method of operation of a neuromodulation system) and a product (a neuromodulation system), which renders the claim indefinite. MPEP 2173.05(p).II states: A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112 , second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011) These rejections may be overcome by amending the claim to (1) recite the method steps of using the neuromodulation system components rather than separately reciting the components of the apparatus or (2) recite an apparatus which is configured to perform the method steps (i.e. amending the claim to be an apparatus claim). • Claim 2 is directed to both a product and a process. Claim 2 is directed to the method of claim 1 and also requires the limitation “wherein the neuromodulation system also includes a patient remote control in communication with the implantable pulse generator,” which defines components of the neuromodulation system. • Claim 3 is directed to both a product and a process. Claim 3 is directed to the method of claim 1 and also requires the limitation “wherein the neuromodulation system includes a patient remote control in communication with the implantable pulse generator, and a lead coupled to the implantable pulse generator,” which defines components of the neuromodulation system. • Claim 4 is directed to both a product and a process. Claim 4 is directed to the method of claim 1 and also requires the limitation “wherein: the neuromodulation system includes a lead having a proximal end for coupling to the pulse generator and a distal end with a plurality of electrodes thereon, wherein the first therapy program is delivered using a first electrode of the plurality of electrodes on the lead,” which defines components of the neuromodulation system. • Claim 5 is directed to both a product and a process. Claim 5 is directed to the method of claim 4 and also requires the limitation “wherein: the operational circuitry includes a memory storing instructions for executing the one or more therapy programs; the memory contains a clinical effects map indicating beneficial combinations of therapy amplitude and lead position that cause clinical benefits and side-effect combinations of therapy amplitude and lead position that cause side effects in the patient; the first therapy program uses a first combination of therapy amplitude and lead position that cause clinical benefits having a first location on the clinical effects map,” which defines components of the neuromodulation system. • Claim 6 is directed to both a product and a process. Claim 6 is directed to the method of claim 4 and also requires the limitation “wherein: the operational circuitry includes a memory storing instructions for executing the one or more therapy programs; the memory contains an anatomical mapping of target locations and avoid locations, relative to the lead in the patient; the first therapy program is configured to issue therapy to a first target location,” which defines components of the neuromodulation system. • Claim 7 is directed to both a product and a process. Claim 7 is directed to the method of claim 4 and also requires the limitation “wherein: the neuromodulation system includes a patient remote control having a memory storing a clinical effects map indicating benefit combinations of therapy amplitude and lead position that cause clinical benefits and side-effect combinations of therapy amplitude and lead position that cause side effects in the patient; the first therapy program uses a first combination of therapy amplitude and lead position that cause clinical benefits having a first location on the clinical effects map,” which defines components of the neuromodulation system. • Claim 8 is directed to both a product and a process. Claim 8 is directed to the method of claim 4 and also requires the limitation “wherein: the neuromodulation system includes a patient remote control having a memory storing an anatomical mapping of target locations and avoid locations, relative to the lead in the patient; the first therapy program is configured to issue therapy to a first target location,” which defines components of the neuromodulation system. • Claim 9 is directed to both a product and a process. Claim 9 is directed to the method of claim 4 and also requires the limitation “wherein: the operational circuitry includes a memory storing instructions for executing at least the first set of program parameters and the second set of program parameters, and an active list identifying which of the plurality of sets of program parameters are available to be selected by a patient for use at any given time,” which defines components of the neuromodulation system. • Claim 14 is directed to both a product and a process. Claim 14 is directed to the method of claim 1 and also requires the limitation “wherein the system also includes a patient remote control configured to present queries to a patient and receive responses therefrom,” which defines components of the neuromodulation system. • Claim 17 is directed to both a product and a process. Claim 17 is directed to the method of claim 15 and also requires the limitation “wherein the system also includes a patient remote control configured to present queries to a patient and receive responses therefrom,” which defines components of the neuromodulation system. • Claim 18 is directed to both a product and a process. Claim 18 is directed to the method of claim 15 and also requires the limitation “wherein: the system also includes a patient remote control adapted to communicate with the implantable pulse generator and having an interface for communicating with the patient; the patient motion sensor is a component of a wearable device; and the patient remote control is further adapted to communicate with the wearable device,” which defines components of the neuromodulation system. Claims 20 is directed to a product (a neuromodulation system) and to a process (method of operation of a neuromodulation system), which renders the claim indefinite. MPEP 2173.05(p).II states: A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112 , second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011) This rejection may be overcome by amending the claim to recite the apparatus configuration, rather than actual method steps (e.g. the operational circuitry is “configured to determine”). • Claim 20 is directed to both a product and a process. Claim 20 is directed to the apparatus of claim 19 and also requires the limitation “the operational circuitry determines a loss of system integrity in response to the data from the patient remote control indicating: the patient was previously satisfied with therapy delivered using the first set of program parameters; and that the patient is no longer satisfied with therapy delivered using the first set of program parameters,” which is a method step. Claims 10-13 and 15-16 are rejected for being dependent on rejected claims. Claim Rejections - 35 USC § 102 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. Claims 1-4, 9-10, and 14-20 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Giftakis (US PG Pub 2018/0071530 A1, see “Notice of References Cited). Regarding Claim 1 , Giftakis discloses a method of operation in a neuromodulation system ([0003] – method of using a neuromodulation system) having an implantable pulse generator including a housing containing operational circuitry ([0041]) configured to deliver therapy to the patient using one or more therapy programs ([0033-0034]) , the method comprising: applying a first set of program parameters to deliver therapy to a patient, the first set of program parameters being in a first therapy program ([0033] – parameters defining programmable waveforms); checking system integrity ([0004-0005] – fault detection performed to identify problems in the circuity such as a short-circuit). The instant specification establishers that system integrity can be assessed via position measurements, impedance measurements, or treatment efficacy feedback (Page 2, Lines 15-21). Giftakis establishes fault detection as similarly being based on position measurements ([0182]), impedance measurements ([0166-0168]), or changes to treatment efficacy ([0198-0201]). determining a loss of system integrity ([0196-0197] – fault detection can be based on position/motion data, impedance, or loss of treatment efficacy); in response to determining a loss of system integrity, applying a second set of program parameters to deliver therapy to the patient, the second set of program parameters being in a second therapy program (Fig. 14, [0198-0201] – determination of change in efficacy with titration used to determine fault, where factors such as impedance or motion are further analyzed to determine the extent of the fault in 178; [0200] – a new, more efficacious setting is selected based on the titration showing a loss of efficacy: “the parameters that are ultimately selected as the most efficacious provide a baseline set of parameters that may be stored within memory 62 and/or memory 82. These parameters may be used to deliver therapy to a patient for a selected period of time after the titration is performed”); obtaining patient feedback ([0197-0198] – the assessment of efficacy during titration is based on patient feedback) in response to the application of the second set of program parameters to deliver therapy to the patient ([0201] – once a new set of parameters is chosen, the method of Fig. 14 can be later repeated to assess potential loss of efficacy of these new parameters) ; and determining whether the patient feedback indicates acceptability of the second set of program parameters ([0201] – acceptability would be a finding of the settings being efficacious). Therefore, Claim 1 is anticipated by Giftakis. Regarding Claim 2, Giftakis anticipates the method according to Claim 1, as indicated hereinabove. Giftakis further discloses wherein the neuromodulation system also includes a patient remote control in communication with the implantable pulse generator ([0089] – a wireless external programmer classified as a patient programmer (as opposed to the clinician programmer) is used to control the electrical stimulator), wherein: • checking system integrity includes obtaining, from the patient remote control ([0198] – user input entered on patient programmer), data indicating whether the patient is satisfied with therapy delivered using the first set of program parameters (Fig. 14, [0198-0201] - determination of change in efficacy with titration used to determine fault based on patient feedback); and • determining a loss of system integrity includes finding that: the patient was previously satisfied with therapy delivered using the first set of program parameters ([0200] – an efficacious set of parameters was selected and becomes a baseline value) ; and that the patient is no longer satisfied with therapy delivered using the first set of program parameters ([0201] – once a set of baseline parameters are chosen, the method of Fig. 14 can be repeated to assess potential loss of efficacy of these baseline settings) . Therefore, Claim 2 is anticipated by Giftakis. Regarding Claim 3, Giftakis anticipates the method according to Claim 1, as indicated hereinabove. Giftakis further discloses the implantable pulse generator, and a lead coupled to the implantable pulse generator (Fig. 3, [0109]), wherein: • checking system integrity includes obtaining one or more of position or impedance data related to the lead ([0196] – impedance or position used to monitor and detect faults, potentially in combination with a loss of efficacy as described in [0197]), and • obtaining, from the patient remote control ([0198] – user input entered on patient programmer) , data indicating whether the patient is satisfied with therapy delivered using the first set of program parameters ([0197-0198] – the assessment of efficacy during titration is based on patient feedback) ; and • determining a loss of system integrity includes finding each of: the position or impedance data related to the lead has changed ([0196] – impedance or position used to monitor and detect faults; Fig. 14, [0198-0201] – determination of change in efficacy with titration used to determine fault, where factors such as impedance or motion are further analyzed to determine the extent of the fault in 178) from a prior state to a current state ([0171-0172] – comparing current to baseline values); and the data from the patient remote control indicates: the patient was previously satisfied with therapy delivered using the first set of program parameters ([0200] – an efficacious set of parameters was selected and becomes a baseline value) ; and the patient is no longer satisfied with therapy delivered using the first set of program parameters ([0201] – once a set of baseline parameters are chosen, the method of Fig. 14 can be repeated to assess potential loss of efficacy of these baseline settings) . Therefore, Claim 3 is anticipated by Giftakis. Regarding Claim 4, Giftakis anticipates the method according to Claim 1, as indicated hereinabove. Giftakis further discloses wherein: • the neuromodulation system includes a lead having a proximal end for coupling to the pulse generator (Fig. 3, [0101-102] – proximal ends of leads 20A and 20B attached to stimulation generator 64) and a distal end with a plurality of electrodes thereon (Fig. 3, [0101-102] – distal ends of leads 20A and 20B contain electrode groups 24 and 26) , wherein the first therapy program is delivered using a first electrode of the plurality of electrodes on the lead ([0113] – stimulation signals applied to electrodes); • the method comprises measuring impedance at the first electrode while therapy is delivered using the first electrode ([0079-0081] - real-time impedance measurements to determine if a fault has occurred); and • determining a loss of system integrity is performed by finding the measured impedance has crossed above a first threshold or below a second threshold, indicating a potential failure with the first electrode ([0082], [0094] – a fault is detected by impedance values being measured outside of a predetermined range). Therefore, Claim 4 is anticipated by Giftakis. Regarding Claim 9 , Giftakis anticipates the method according to Claim 4, as indicated hereinabove. Giftakis further discloses wherein: • the operational circuitry includes a memory storing instructions for executing at least the first set of program parameters and the second set of program parameters ([0102] – memory to store different sets of parameters) , and an active list identifying which of the plurality of sets of program parameters are available to be selected by a patient for use at any given time ([0089] – programmer which contains a user interface with selectable programs, as exemplified in Figs. 16-19, [0096] – programmer allows adjustment of parameters or constraint of values within a specific range); • the method includes determining that the second set of program parameters is not in-use at the time the loss of system integrity occurs, and the first set of program parameters is in use at the time the loss of system integrity occurs ([0197-0201] – change parameters from first set to a second set to make the treatment more efficacious again after a fault is detected during titration); and • the method includes removing the first set of program parameters from the active list, and adding the second set of program parameters to the active list ([0089], [0121] – the programmer updates the stored program with new parameter values in response to therapeutic needs). Therefore, Claim 9 is anticipated by Giftakis. Regarding Claim 10 , Giftakis anticipates the method according to Claim 4, as indicated hereinabove. Giftakis further discloses wherein the second set of program parameters does not use the first electrode in therapy delivery ([0065-0066] – different electrode combinations are tried in order to identify and isolate electrode combinations causing the fault). Therefore, Claim 10 is anticipated by Giftakis. Regarding Claim 14 , Giftakis anticipates the method according to Claim 1, as indicated hereinabove. Giftakis further discloses wherein the system also includes a patient remote control ([0089-0090] – patient programmer) configured to present queries to a patient and receive responses therefrom ([0093], [0190], [0192], [0197-0198] – patient feedback provided via programmer), wherein the step of obtaining patient feedback includes communicating to the patient remote control to present a query to the patient, and then receiving an indication of the patient feedback from the patient remote control ([0198] – in response to a change in settings, “In some cases, the patient may provide feedback, as by entering information into an electronic diary”). Therefore, Claim 14 is anticipated by Giftakis. Regarding Claim 15 , Giftakis anticipates the method according to Claim 1, as indicated hereinabove. Giftakis further discloses wherein the step of obtaining patient feedback includes monitoring a patient motion sensor to analyze one or more of gait or tremor ([0198] – “In some cases, automated feedback may be provided as a user performs a task. For instance, accelerometers and/or other motion/activity sensors may be used to access tremor, determine smoothness and/or speed of gait, the quickness of a finger tap exercise, and so on”). Therefore, Claim 15 is anticipated by Giftakis. Regarding Claim 16, Giftakis anticipates the method according to Claim 15, as indicated hereinabove. Giftakis further discloses wherein the patient motion sensor is contained in or on the implantable pulse generator ([0120], [0146] – IMD is described as containing an on-board accelerometer). Note the specification at page 12, lines 26-31 (see Figure 2) defines the implantable pulse generator as having housing 50 which also contains the stimulator 54, meaning the IMD in Giftakis is equivalent to the implantable pulse generator in the instant application. Therefore, Claim 16 is anticipated by Giftakis. Regarding Claim 17 , Giftakis anticipates the method according to Claim 15, as indicated hereinabove. Giftakis further discloses wherein the patient motion sensor is a component of a wearable device ([0192] – “As still another example, a movement indication may be provided automatically by an accelerometer, gyroscope, or other movement sensor worn by the patient”) , and the implantable pulse generator contains communication circuitry configured to communicate with the wearable device ([0188-0194] – the motion data from the sensor is communicated to the analysis system in order to determine if motion artifacts are causing the detected faults). Therefore, Claim 17 is anticipated by Giftakis. Regarding Claim 18, Giftakis anticipates the method according to Claim 15, as indicated hereinabove. Giftakis further discloses wherein: • the system also includes a patient remote control adapted to communicate with the implantable pulse generator and having an interface for communicating with the patient ([0089] – a wireless external programmer classified as a patient programmer (as opposed to the clinician programmer) is used to control the electrical stimulator) ; • the patient motion sensor is a component of a wearable device ([0192] – “As still another example, a movement indication may be provided automatically by an accelerometer, gyroscope, or other movement sensor worn by the patient”) ; and • the patient remote control is further adapted to communicate with the wearable device ([0198] – communication with accelerometer). Therefore, Claim 18 is anticipated by Giftakis. Regarding Claim 19 , Giftakis discloses a neuromodulation system ([0003] – system to deliver neuromodulation, such as deep brain stimulation) comprising an implantable pulse generator including a housing containing operational circuitry having therein a microcontroller and a memory ([0041] – “IMD 16 can comprise a hermetic outer housing 34, which substantially encloses components, such as a processor, therapy module, and memory”) , the memory storing patient data and readable instructions for one or more programs for treating the patient ([0101-0102], [0105-0106], [0108] – memory used to store program instructions and patient data); wherein the operational circuitry is configured to: • apply a first set of program parameters to deliver therapy to a patient ([0033] – parameters defining programmable waveforms), the first set of program parameters stored in the memory ([0102]); • check system integrity ([0004-0005] – fault detection performed to identify problems in the circuity such as a short-circuit). The instant specification establishers that system integrity can be assessed via position measurements, impedance measurements, or treatment efficacy feedback (Page 2, Lines 15-21). Giftakis establishes fault detection as similarly being based on position measurements ([0182]), impedance measurements ([0166-0168]), or changes to treatment efficacy ([0198-0201]). • determine a loss of system integrity ([0196-0197] – fault detection can be based on position/motion data, impedance, or loss of treatment efficacy); •obtain or determine a second set of program parameters in response to the loss of system integrity; apply the second set of program parameters to deliver therapy to the patient (Fig. 14, [0198-0201] – determination of change in efficacy during titration used to determine fault, where factors such as impedance or motion are further analyzed to determine the extent of the fault in 178; [0200] – a new, more efficacious setting is selected based on titration showing a loss of efficacy: “the parameters that are ultimately selected as the most efficacious provide a baseline set of parameters that may be stored within memory 62 and/or memory 82. These parameters may be used to deliver therapy to a patient for a selected period of time after the titration is performed”); • obtain patient feedback ([0197-0198] – the assessment of efficacy during titration is based on patient feedback) in response to the application of the second set of program parameters to deliver therapy to the patient ([0201] – once a new set of parameters is chosen, the method of Fig. 14 can be later repeated to assess potential loss of efficacy of these new parameters) ; and • determine whether the patient feedback indicates acceptability of the second set of program parameters ([0201] – acceptability would be a finding of the settings being efficacious). Therefore, Claim 19 is anticipated by Giftakis. Regarding Claim 20 , Giftakis anticipates the neuromodulation system according to Claim 19, as indicated hereinabove. Giftakis discloses further comprising a patient remote control, wherein the operational circuitry comprises a communications circuit adapted to communicate with the patient remote control ([0089] – a wireless external programmer classified as a patient programmer (as opposed to the clinician programmer) is used to control the electrical stimulator) , wherein: • the operational circuitry is configured to check system integrity by obtaining, from the patient remote control ([0198] – user input entered on patient programmer) , data indicating whether the patient is satisfied with therapy delivered using the first set of program parameters (Fig. 14, [0198-0201] – determination of change in efficacy during titration based on patient feedback); and • the operational circuitry determines a loss of system integrity in response to the data from the patient remote control (Fig. 14, [0198-0201] – determination of change in efficacy during titration used to determine fault, where factors such as impedance or motion are further analyzed to determine the extent of the fault in 178) indicating: the patient was previously satisfied with therapy delivered using the first set of program parameters ([0200] – an efficacious set of parameters was selected and became a baseline value) ; and that the patient is no longer satisfied with therapy delivered using the first set of program parameters ([0201] – once a set of baseline parameters is chosen, the method of Fig. 14 can be repeated to assess potential loss of efficacy of these baseline settings) . Therefore, Claim 20 is anticipated by Giftakis. 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: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue Resolving the level of ordinary skill in the pertinent art. Considering objective evidence present in the application indicating obviousness or non-obviousness. Claims 5-8 are rejected under U.S.C 103 as being unpatentable over Giftakis (US PG Pub 2018/0071530 A1, see “Notice of References Cited) in view of Roothans (US PG Pub 2016/0144194 A1, see “Notice of References Cited”). Regarding Claim 5 , Giftakis anticipates the method according to Claim 4, as indicated hereinabove. Giftakis further discloses wherein: • the operational circuitry includes a memory storing instructions for executing the one or more therapy programs ([0102]); • the first therapy program uses a first combination of therapy amplitude and lead position that cause clinical benefits having a first location ([0033], [0109] – the amplitude settings and electrode combinations to determine location of stimulation are used to provide a specific therapy to the target area of the brain) ; and • the method comprises determining the second set of program parameters in response to the loss of system integrity by identifying a second location that uses a combination of therapy amplitude and lead position ([0065-0066] – different electrode combinations are tested to identify combinations of stimulation intensity which are effective at different locations in the brain) which indicates will cause clinical benefits and not side effects ([0088] – “electrical stimulation may be directed to a specific direction from leads 20 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue”). Giftakis does not disclose the memory contains a clinical effects map indicating beneficial combinations of therapy amplitude and lead position that cause clinical benefits and side-effect combinations of therapy amplitude and lead position that cause side effects in the patient. Roothans, in the same field of endeavor of providing deep brain stimulation via the selection of combinations of electrodes ([0003-0004]), teaches a memory storing a clinical effects map for selecting an efficacious combination of stimulation parameters and electrodes ([0131-0136]). Roothans teaches the “processor 360 of IMD 350 may receive, as updates to programs, values for various stimulation parameters such as amplitude and electrode combination, from programmer device 400 via telemetry module 370. The updates to the therapy programs may be stored within therapy programs 374 portion of memory 362” ([0127]). Roothans additionally teaches: “ regions 412 stores information identifying one or more regions of tissue of the patient's brain (or another part of the body of the patient) associated with efficacious therapy delivery. These regions may be referred to as efficacy regions. Regions 412 also stores information identifying one or more regions of tissue of the patient's brain (or another part of the body of patient) associated with adverse stimulation effects. These regions may be referred to as adverse-effects regions” ([0132]). Roothans describes the time-saving nature of incorporating a clinical effects map ([0019]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Giftakis’ method of operation in a neuromodulation system by incorporating the clinical effects map for choosing stimulation parameters and electrode combinations in Roothans. This would have been obvious because both Giftakis and Roothans evaluate deep brain stimulation therapy and adjust settings to provide more efficacious therapy and Roothans provides a clinical effects map to estimate the probability of either effective therapy or side effects before applying stimulation with selected combinations of electrodes, which quickly tailors therapy without excessive trial and error corrections. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Giftakis by incorporating the clinical effects map for choosing stimulation parameters and electrode combinations in Roothans. Therefore, Claim 5 is obvious over Giftakis in view of Roothans. Regarding Claim 6 , Giftakis anticipates the method according to Claim 4, as indicated hereinabove. Giftakis further discloses wherein: • the operational circuitry includes a memory storing instructions for executing the one or more therapy programs ([0102] – therapy programs stored in memory); • the first therapy program is configured to issue therapy to a first target location ([0033], [0109] – the amplitude settings and electrode combinations to determine location of stimulation are used to provide a specific therapy to the target area of the brain) ; and • the method comprises determining the second set of program parameters in response to the loss of system integrity by identifying a second target location that is not the first target location ([0065-0066] – different electrode combinations are tested to identify combinations which are effective in response to a fault) , and configuring the second set of program parameters to issue therapy to the second target location ([0065-0066] – stimulation provided to second locations in the brain) . Giftakis does not disclose the memory contains an anatomical mapping of target locations and avoid locations, relative to the lead in the patient. Regarding Roothans’ clinical effects map in claim 5, Roothans teaches a memory storing a clinical effects map for selecting an efficacious combination of stimulation parameters and electrodes ([0131-0136]). Roothans teaches stimulation programs can be updated in terms of stimulation parameters and electrode combinations ([0127]). Roothans additionally teaches anatomical locations can either be marked as effective targets or as causing side effects ([0132]). Roothans describes the time-saving nature of incorporating a clinical effects map ([0019]). Therefore, Claim 6 is obvious over Giftakis in view of Roothans. Regarding Claim 7, Giftakis anticipates the method according to Claim 4, as indicated hereinabove. Giftakis further discloses wherein: • the neuromodulation system includes a patient remote control ([0089] – a wireless external programmer classified as a patient programmer (as opposed to the clinician programmer) is used to control the electrical stimulator) having a memory ([0102] – therapy programs stored in memory) indicating benefit combinations of therapy amplitude and lead position ([0033], [0109]) that cause clinical benefits ([0088] – “to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue”) ; and side-effect combinations of therapy amplitude and lead position ([0033], [0109]) that cause side effects in the patient ([0088]) ; • the first therapy program uses a first combination of therapy amplitude and lead position that cause clinical benefits having a first location ([0033], [0109] – the amplitude settings and electrode combinations to locate the stimulation are used to provide a specific therapy to the target area of the brain) ; • the method includes: identifying a second location that uses a second combination of therapy amplitude and lead position indicates will cause clinical benefits and not side effects ([0065-0066] – stimulation provided to second locations in the brain; [0088] – provide benefits and reduce side effects) ; determining the second set of program parameters from the second combination of therapy amplitude and lead position ([0065-0066] – different electrode combinations are tested to identify combinations which are effective at different locations in the brain) ; and the patient remote control communicating the second set of program parameters to the implantable pulse generator ([0089], [0121] – the programmer updates the stored program with new parameter values to be applied to the implantable generator in response to therapeutic needs) . Giftakis does not disclose the neuromodulation system includes a patient remote control having a memory storing a clinical effects map indicating benefit combinations of therapy amplitude and lead position that cause clinical benefits and side-effect combinations of therapy amplitude and lead position that cause side effects in the patient. Regarding Roothans’ clinical effects map in claim 5, Roothans teaches a memory storing a clinical effects map for selecting an efficacious combination of stimulation parameters and electrodes ([0131-0136]). Roothans teaches stimulation programs can be updated in terms of stimulation parameters and electrode combinations ([0127]). Roothans additionally teaches locations can either be marked as effective targets or as causing side effects ([0132]). Roothans describes the time-saving nature of incorporating a clinical effects map ([0019]). Therefore, Claim 7 is obvious over Giftakis in view of Roothans. Regarding Claim 8, Giftakis anticipates the method according to Claim 4, as indicated hereinabove. Giftakis further discloses wherein: • the neuromodulation system includes a patient remote control ([0089], [0096-0097]); • the first therapy program is configured to issue therapy to a first target location ([0033], [0109] – the amplitude settings and electrode combinations direct stimulation to provide a specific therapy to the target area of the brain) ; and the method includes: determining the second set of program parameters in response to the loss of system integrity by identifying a second target location that is not the first target location ([0065-0066] – different electrode combinations are tested to identify combinations which are effective at different locations in the brain) , and configuring the second set of program parameters to issue therapy to the second target location ([0065-0066] – stimulation provided to second locations in the brain) ; and the patient remote control communicating the second set of program parameters to the implantable pulse generator ([0089], [0121] – the programmer updates the stored program with new parameter values to be applied to the implantable generator in response to therapeutic needs). Giftakis does not disclose the neuromodulation system includes a patient remote control having a memory storing an anatomical mapping of target locations and avoid locations, relative to the lead in the patient. Regarding Roothans’ clinical effects map in claim 5, Roothans further teaches a programmer with a user interface ([0069-0071], [0129] – patient programmer) where a clinical effects map for selecting an efficacious combination of stimulation parameters and electrodes is stored in memory ([0131-0136]). Roothans teaches stimulation programs can be updated in terms of stimulation parameters and electrode combinations ([0127]). Roothans additionally teaches locations can either be marked as effective targets or as causing side effects ([0132]). Roothans describes the time-saving nature of incorporating a clinical effects map ([0019]). Therefore, Claim 8 is obvious over Giftakis in view of Roothans. Claims 11-13 are rejected under U.S.C 103 as being unpatentable over Giftakis (US PG Pub 2018/0071530 A1, see “Notice of References Cited) in view of Giuffrida (US 9,289,603 B1, see “Notice of References Cited”). Regarding Claim 11 , Giftakis anticipates the method according to Claim 1, as indicated hereinabove. Giftakis discloses further comprising: • generating an alert to request a change in response to the loss of system integrity ([0154] – “In this manner, the system may automatically provide guidance as to the likely cause of the fault and/or may even recommend an action to be taken to remedy the fault”). However, Giftakis does not disclose: • receiving a response to the alert, approving the change; • wherein the method includes waiting to apply the second set of program parameters to deliver therapy to the patient until after receiving the response approving the change. Giuffrida, in the same field of endeavor of providing deep brain stimulation (Col 1, Lines 19-49) via adjustment of stimulation settings (Col 6, Lines 27-67), teaches a step of a clinician review of recommended parameters before the recommended parameters are entered into the therapy device (Col 38, Lines 1-14 ; Col 37, Lines 43-52). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Giftakis’ method of operation in a neuromodulation system by incorporating a requirement for user approval before automatically implementing recommended new stimulation parameters in Giuffrida. This would have been obvious because both Giftakis and Giuffrida evaluate deep brain stimulation therapy and adjust settings to provide more efficacious therapy and Giuffrida provides a step to obtain a programmer’s approval before the device automatically changes stimulation parameters as a safety check. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Giftakis by incorporating a requirement for user approval before automatically implementing recommended new stimulation parameters in Giuffrida. Therefore, Claim 11 is obvious over Giftakis in view of Giuffrida. Regarding Claim 12, Giftakis anticipates the method according to Claim 11, as indicated hereinabove. Giftakis does not disclose wherein the step of generating an alert to request a change includes sending the second set of program parameters with the request. Regarding Giuffrida’s alert to request a change in claim 11, Giuffrida further teaches a step of a clinician review of recommended parameters before the recommended parameters are entered into the therapy device (Col 38, Lines 1-14 -the recommended set of parameters is reviewed by the clinician for approval before implementation; Col 37, Lines 43-52 – “communicates any data and suggested DBS parameter settings to the clinician, physician or technician”). Therefore, Claim 12 is obvious over Giftakis in view of Giuffrida. Regarding Claim 13 , Giftakis anticipates the method according to Claim 11, as indicated hereinabove. Giftakis does not disclose wherein the step of generating an alert to request a change includes alerting a physician. Regarding Giuffrida’s alert to request a change in claim 11, Giuffrida further teaches a step of a clinician review of recommended parameters before the recommended parameters are entered into the therapy device (Col 38, Lines 1-14 and Col 37, Lines 43-52). Therefore, Claim 13 is obvious over Giftakis in view of Giuffrida. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 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, Jennifer McDonald can be reached on 571-270-3061. 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. /Benjamin A. Schmitt/ Examiner Art Unit 3796 /William J Levicky/Primary Examiner, Art Unit 3796 Application/Control Number: 18/956,972 Page 2 Art Unit: 3796 Application/Control Number: 18/956,972 Page 3 Art Unit: 3796 Application/Control Number: 18/956,972 Page 4 Art Unit: 3796 Application/Control Number: 18/956,972 Page 5 Art Unit: 3796 Application/Control Number: 18/956,972 Page 6 Art Unit: 3796 Application/Control Number: 18/956,972 Page 7 Art Unit: 3796 Application/Control Number: 18/956,972 Page 8 Art Unit: 3796 Application/Control Number: 18/956,972 Page 9 Art Unit: 3796 Application/Control Number: 18/956,972 Page 10 Art Unit: 3796 Application/Control Number: 18/956,972 Page 11 Art Unit: 3796 Application/Control Number: 18/956,972 Page 12 Art Unit: 3796 Application/Control Number: 18/956,972 Page 13 Art Unit: 3796 Application/Control Number: 18/956,972 Page 14 Art Unit: 3796 Application/Control Number: 18/956,972 Page 15 Art Unit: 3796 Application/Control Number: 18/956,972 Page 16 Art Unit: 3796 Application/Control Number: 18/956,972 Page 17 Art Unit: 3796 Application/Control Number: 18/956,972 Page 18 Art Unit: 3796 Application/Control Number: 18/956,972 Page 19 Art Unit: 3796 Application/Control Number: 18/956,972 Page 20 Art Unit: 3796 Application/Control Number: 18/956,972 Page 21 Art Unit: 3796 Application/Control Number: 18/956,972 Page 22 Art Unit: 3796 Application/Control Number: 18/956,972 Page 23 Art Unit: 3796
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