CTNF 18/893,364 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. Specification 07-29 AIA The disclosure is objected to because of the following informalities: Application Serial No. is missing from Specification [0002] line 2 . Appropriate correction is required. 07-30-03-h AIA Claim Interpretation The term “pattern” is interpreted to comprise any programmable stimulation parameter such as amplitude and/or electrode configuration and any combination thereof herein [0059]. The term “dimensions” is interpreted to comprise patient feedback for categorical metrics such as pain and/or emotional state herein [00103]. 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 1-20 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 of significantly more than the judicial exception. Under Step 1 : Independent claims 1, 9, and 11 are directed to a system and a method, and thus, the claims all fall under one of the four patent eligible categories. Under Step 2A, Prong 1 : Claims 1, 9, & 11 recite steps for receiving an objective function, model, and patterns of neurostimulation; determining an optimal pattern of neurostimulation for first stimulation parameters by using a simulation with said objective function that corresponds to minimized values of second stimulation parameters, model, and patterns of neurostimulation; and generating information for programming neurostimulation according to said optimal pattern of neurostimulation. Under broadest reasonable interpretation, these limitations appear to be directed to mental processes because they concern observing and evaluating signal data using mathematical formulas and identifying and selecting optimal stimulation parameters which can be performed in the mind or with pen and paper. A trained clinician can evaluate a set of data gathered from a patient; derive an objective function from said data; construct a mathematical model to simulate the effects of neurostimulation on said patient; identify effective neurostimulation patterns for therapy of said patient; and optimize selection of neurostimulation parameters by iterating through said steps until objective function is minimized. Accordingly, claims 1, 9, & 11 are directed to a judicial exception including one or more abstract ideas under mental processes. Dependent claims 2 & 12 recite additional limitations for determining the fixed value or value range for each parameter of the first stimulation parameters using the simulation with the objective function and the model but appear to be directed to mental processes because they concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claims 3, 10, & 13 recite additional steps for receiving patient information from assessments including dimensions of neurostimulation and calibration information including patient’s response to neurostimulation; and determining the objective function using said patient dimensions and model state personalized to the patient using said response to neurostimulation. These limitations appear to be directed to mental processes because they concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claim 4 recites additional steps to program the implantable stimulator but appears to be directed to mental processes because it concerns selecting data through observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claims 5 & 6 recite additional steps to personalize the model and to receive the personalized model but appears to be directed to mental processes because they concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claims 7 & 8 recite additional steps to select a pattern and to determine the optimal pattern by tuning the selected pattern using the objective function and the model but appears to be directed to 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 receiving the patterns of neurostimulation comprises neurostimulation pulses but appears to be directed to mental processes because it concerns observations and judgements which can be performed in the mind or with pen and paper. Dependent claim 15 recites an additional limitation of receiving dynamic patterns of neurostimulation affected by a modulating waveform but appears to be directed to mental processes because it concerns observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claim 16 recites additional limitations of stimulation parameters comprising at least one of a pulse amplitude, a pulse width, or a pulse frequency that is modulated by modulation depth and modulation frequency; and generating the information for programming comprises a modulation depth between 0% and 40% and modulation frequency between 0.5 Hz and 1.1 Hz but appears to be directed to mental processes because they further limit an abstract process and concern observations, calculations, and judgements which can be performed in the mind or with pen and paper. Dependent claim 17 recites an additional limitation of the first stimulation parameters comprise a pulse frequency but appears to be directed to mental processes because it further limits an abstract process. Dependent claim 18 recites an additional limitation wherein generating the information for programming comprises setting the pulse frequency to between 20 Hz and 30 Hz but appears to be directed to mental processes because it further limits an abstract process. Dependent claim 19 recites an additional limitation wherein the first stimulation parameters comprise a pulse width frequency but appears to be directed to mental processes because it further limits an abstract process. Dependent claim 20 recites an additional limitation wherein generating the information for programming comprises setting the pulse width to between 0.25 ms and 0.4 ms but appears to be directed to mental processes because it further limits an abstract process. Under Step 2A, 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, 9, & 11 fail to include any additional elements that integrate the abstract idea into a practical application. Claim 1 includes a pattern optimization circuit and the step of receiving an objective function, a model, and patterns of neurostimulation wherein the circuit is a generic computer structure for implementing the abstract idea on a computer and receiving is insignificant pre-solution activity; an optimization processing circuitry and the step to determine an optimal pattern of neurostimulation using a simulation wherein the processing circuitry is a generic computer structure for implementing the abstract idea on a computer; and a programming control circuit and the step to generate information for programming wherein the control circuit is a generic computer structure for implementing the abstract idea on a computer and generate information is insignificant post-solution activity. Claim 3 includes a personalization circuit and the steps of receiving patient-specific information including patient dimensions of neurostimulation and calibration information including the patient’s response to neurostimulation wherein the circuit is a generic computer structure for implementing the abstract ideas on a computer and receive is insignificant pre-solution activity; a personalization processing circuitry with the steps to determine the objective function and model state wherein the processing circuitry is a generic computer structure for implementing the abstract ideas on a computer. Claim 4 includes an implantable stimulator and an external programming device with additional steps to program the implantable stimulator and additional limitations of the external programming device including the pattern optimization circuit and the programming control circuit wherein the implantable stimulator only generally links the abstract idea to another technology or field of use; and the external programming device is a generic computer structure that includes the pattern optimization circuit and the programming control circuit for implementing the abstract ideas on a computer. Claims 5 & 6 include a personalization circuit and steps to receive the personalized model wherein the personalization circuit is a generic computer structure for implementing the abstract ideas on a computer; and to receive is insignificant pre-solution activity. Claim 5 includes a remote device from which the personalized model is determined wherein the remote device is a generic computer structure for implementing the abstract ideas on a computer. Claims 7 & 8 include optimization processing circuitry and steps to select a pattern of neurostimulation wherein the optimization processing circuitry is a generic computing structure for implementing the abstract ideas on a computer; and to select is insignificant post-solution activity. 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, “pattern optimization circuit”, “optimization processing circuitry”, “programming control circuit”, “personalization circuit”, and “remote device”, and “external programming device” 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 : Claims 1, 9, & 11 fail to include any additional elements that, alone or in combination, amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the claim 1 limitation to determine using a simulation with the objective function, the model, and patterns of neurostimulation and the additional elements of “pattern optimization circuit”, “optimization processing circuitry”, “programming control circuit”, “personalization circuit”, “remote device”, “external programming device”, and “implantable stimulator” are well-understood, routine, and conventional activities previously known in the field of neurostimulation as indicated in the following references: US 2014/0005743 A1: See [0134] for determine using a simulation with the objective function, the model, and patterns of neurostimulation; See [0009] for external programming device and IPG for implantable stimulator; See [0108] intelligent remote system for remote device; See [0078] micro-controller; [0083-0084] data acquisition circuitry, inputs; [0136] tuning algorithm; [0147] tuning maps; for “pattern optimization circuit”, “optimization processing circuitry”, “programming control circuit”, and “personalization circuit.” US 2017/0100601 A1: See [0009], [0053] for determine using a simulation with the objective function, the model, and patterns of neurostimulation; See [0031] programmer device (502, Fig. 5) for external programming device and remote device; [0031], Fig. 1 pulse generator (108) for implantable stimulator; See [0031], Fig. 6A microprocessor; [0037], Fig. 6A data lead engine (606); [0041], Fig. 6A optimization engine (608); [0035], Fig. 6A brain geometry engine (604); for “pattern optimization circuit”, “optimization processing circuitry”, “programming control circuit”, and “personalization circuit.” 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 3 & 10 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 3, line 8, recites “determine the objective function” and claim 10, line 8, recites “determining the objective function.” These claims can be construed to mean that the objective function, to be used with the received patient dimensions, is determined by the circuitry or that the circuitry determines the objective function using the received patient dimensions by providing an optimized output value. It is unclear if the determination is for the objective function itself, or the result obtained from the objective function. Therefore, one of ordinary skill in the art cannot reasonably determine the metes and bounds necessary to distinctly claim the subject matter. Examiner interprets these recitations to mean determine the objective function using the patient dimensions by providing an optimized output value herein. 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) 1-13 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Giuffrida et al (US Pre Grant Publication 2014/0005743 A1) . Regarding claims 1 & 9, Giuffrida teaches a system (Fig. 1, therapy device not shown) for delivering neurostimulation to a patient using a stimulation device [0113], the system comprising: a pattern optimization circuit (6, Fig.1; including tuning assistant software and at least tuning algorithm) [0118] including: an objective function input configured to receive an objective function (6, Fig.1; including tuning assistant software and at least tuning algorithm) ([0117-0118], [0134]; “The tablet computer 6 is used to collect data transmitted from the control module 3, allow user inputs to store and track motor performance and therapy device parameter settings, and provide clinicians with real-time symptom quantification feedback.”), a model input configured to receive a model (6, including tuning assistant software and at least tuning algorithm) ([0117-0118], [0124], Fig. 4; “In other embodiments, an algorithm of tablet computer 6 then computes suggested therapy device parameter settings based at least in part upon the current therapy device parameter settings and the collected movement data and/or the quantified score computed therefrom”); a pattern input configured to receive one or more patterns of neurostimulation each including multiple stimulation parameters ([0117-0118], [0143]; tablet computer (6) stores and tracks therapy parameter settings for tuning maps (20) generated for tasks, symptoms, and/or side effects) and optimization processing circuitry configured to determine an optimal pattern of neurostimulation using a simulation with the objective function ([0134], Fig. 3; quantified score derived from objective function; “Thus, one objective function is to minimize the sum of average tremor score (ATS) and average bradykinesia score (ABS), known as the summed motor score (SMS) 11”), the model ([0134]; “The tuning algorithm output provides a suggested parameter direction output after each motor task evaluation by utilizing the movement disorder quantification algorithm”), and the one or more patterns of neurostimulation ([0124]; “The processor of the tablet computer 6 processes the movement data to extract kinematic features which are then fed into a trained algorithm implemented as a software algorithm in the tablet computer 6.”), the optimal pattern of neurostimulation including one or more first stimulation parameters and one or more second stimulation parameters, the one or more first stimulation parameters each identified by the simulation to have a fixed value or value range with which a sensitivity to values of each of the one or more second stimulation parameters on the objective function is identified by the simulation to be minimized ([0134], Fig. 3; “This objective is achieved in the tuning algorithm by continuing to increase stimulation in the same direction as long as SMS is decreasing. A higher SMS corresponds to worse motor symptoms.”; first stimulation parameters continue in the same direction as long as second stimulation decreases (summed motor score (SMS); SMS is objective function that minimizes average tremor score (ATS) and average bradykinesia score (ABS))); and a programming control circuit (6, Fig. 1; including tuning assistant software and at least tuning algorithm) configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to the optimal pattern of neurostimulation ([0134]; “The tuning algorithm output provides a suggested parameter direction output after each motor task evaluation by utilizing the movement disorder quantification algorithm.”). Regarding claim 2, Giuffrida teaches the system of claim 1, and further teaches a system wherein the optimization processing circuitry is configured to use the simulation with the objective function and the model to identify the one or more first stimulation parameters from the multiple stimulation parameters of the optimal pattern of neurostimulation and to determine the fixed value or value range for each parameter of the identified one or more first stimulation parameters ([0134]; clinician sets initial parameter settings or fixed value or value range, then adjusts settings in subsequent iterations wherein the tuning algorithm output suggests an optimal fixed value or value range based on model simulation that minimizes objective function or SMS score using initial or previous values for parameter settings). Regarding claims 3 & 10, Giuffrida teaches the system of claim 2, and teaches a system further comprising a personalization circuit including: an assessment input (6; with at least movement disorder diagnostic device (2) and command module (3), Fig. 1) and configured to receive patient-specific information resulting from a patient assessment, the patient-specific information including one or more patient dimensions of the neurostimulation ([0122]; patient uses display unit to input answers to self-assessment questions that comprise symptom severity and level of activity throughout the day); a calibration input (6; with at least therapy device) configured to receive calibration information resulting from a patient calibration, the calibration information including the patient’s response to the neurostimulation ([0133]; baseline measurements used to determine best monopolar electrode contact that provides largest therapeutic benefit). personalization processing circuitry (6) configured to determine the objective function using the received one or more patient dimensions and to determine the model having a model state personalized to the patient’s response to the neurostimulation ([0124], [0136]; trained algorithm outputs a quantified score computed from collected movement data or patient dimensions; [0134], Fig. 3, Fig. 4; tablet (6, Fig. 1) determines objective function from patient assessment responses or patient dimensions and minimizes SMS). Regarding clam 4, Giuffrida teaches the system of claim 1, and further teaches a system comprising: the stimulation device being an implantable stimulator (Fig. 1; therapy device not shown) ([0113]; therapy device is an implanted DBS device); and an external programming device (6) configured to be communicatively coupled to the implantable stimulator via telemetry and to program the implantable stimulator [0120], the external programming device including the pattern optimization circuit (6, Fig.1; including tuning assistant software and at least tuning algorithm) [0118] and the programming control circuit (6, Fig. 1; including tuning assistant software and at least tuning algorithm) [0134]. Regarding claim 5, Giuffrida teaches the system of claim 4, and teaches a system further comprising a remote device (intelligent remote system; at least one of centralized database or cloud-based database) configured to be communicatively coupled to the external programmer (6) via a telecommunication network ([0121]; external programmer can communicate with either centralized database or cloud-based database) and including a personalization circuit configured to personalize the model to the patient, and wherein the model input is configured to receive the personalized model from the remote device ([0108]; “The system may provide automated, objective functional mapping algorithms to take the programming expertise out of the hands of a clinician”). Regarding claim 6, Giuffrida teaches the system of claim 4, and further teaches a system wherein the external programmer (6, Fig.1; including tuning assistant software and at least tuning algorithm) further comprises a personalization circuit configured to personalize the model to the patient, and wherein the model input is configured to receive the personalized model from the personalization circuit ([0118]; personalization model or tuning algorithm adjusts and stores therapy device parameter settings prior to programming of implantable device). Regarding claim 7, Giuffrida teaches the system of claim 1, and further teaches a system wherein the received one or more patterns of neurostimulation (45, Fig. 8) ([0149]; tuning map (45) or patterns of neurostimulation represents a grouping of therapy parameters comprising a performed task, symptom, or side effect) comprise multiple patterns of neurostimulation, and the optimization processing circuitry (42, at least one of automated or intelligent system) is configured to select the optimal pattern of neurostimulation from the multiple patterns of neurostimulation ([0149], Fig. 8; “Alternatively, the system may utilize the tuning map 45 to suggest DBS parameters that will activate the necessary therapeutic regions, avoid the side effect regions, and optimize the life of the device (i.e., battery life, etc.)”). Regarding claim 8, Giuffrida teaches the system of claim 1, and further teaches a system wherein the received one or more patterns of neurostimulation comprise multiple patterns of neurostimulation (20, Fig. 6) [0143], and the optimization processing circuitry is configured to select a pattern of neurostimulation from the multiple patterns of neurostimulation ([0143], Fig. 6; “In such embodiments, for example, the axis would provide a representation of a group (e.g., 1 representing group 1), which would comprise a predetermined set of therapy parameters or settings being tested, where the grouping may include variations of any of the above described therapy parameters or settings, such as contact, current, frequency, waveform, polarity, pulse width, and the like, as well as combinations thereof.”) and to determine the optimal pattern of neurostimulation by tuning the selected pattern of neurostimulation using the objective function and the model ([0147], Fig. 6; combination (27) is a result of combining tuning maps A and B thereby allowing tuning software to determine optimal parameters or patterns of neurostimulation; combined scores are optimized according to objective function). Regarding claim 11, Giuffrida teaches a method for delivering neurostimulation to a patient, the method comprising: receiving an objective function ([0117-0118], [0134]); receiving a model ([0117-0118], [0124], Fig. 4); receiving one or more patterns of neurostimulation each including multiple stimulation parameters ([0117-0118], [0143]); determining an optimal pattern of neurostimulation using a simulation with the objective function ([0134], Fig. 3), the model [0134], and the one or more patterns of neurostimulation [0124], the optimal pattern of neurostimulation including one or more first stimulation parameters and one or more second stimulation parameters, the one or more first stimulation parameters each identified by the simulation to have a fixed value or value range with which a sensitivity to values of each of the one or more second stimulation parameters on the objective function is identified by the simulation to be minimized ([0134], Fig. 3); and generating information for programming a stimulation device to deliver the neurostimulation according to the optimal pattern of neurostimulation [0134]. Regarding claim 12, Giuffrida teaches the method of claim 11, and teaches a method further comprising identifying the one or more first stimulation parameters from the multiple stimulation parameters of the optimal pattern of neurostimulation and determining the fixed value or value range for each parameter of the identified one or more first stimulation parameters using the simulation with the objective function and the model [0134]. Regarding claim 13, Giuffrida teaches the method of claim 12, and a method further comprising: receiving patient-specific information resulting from a patient assessment, the patient-specific information including one or more patient dimensions of the neurostimulation [0122]; receiving calibration information resulting from a patient calibration, the calibration information including the patient's response to the neurostimulation [0133]; determining the objective function using the received one or more patient dimensions ([0124], [0136]); and determining the model having a model state personalized to the patient's response to the neurostimulation ([0134], Fig. 3, Fig. 4) . 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) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giuffrida et al (US Pre Grant Publication 2014/0005743 A1) , and in view of Buddha et al (US Pre Grant Publication 2022/0176133 A1) . Regarding claim 14, Giuffrida teaches the method of claim 11, but does not disclose wherein receiving the one or more patterns of neurostimulation comprises receiving one or more patterns of neurostimulation pulses as claimed. However, Buddha teaches wherein receiving the one or more patterns of neurostimulation comprises receiving one or more patterns of neurostimulation pulses ([0180], [0262], [0305-0306], [0308]). 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 method of Giuffrida with the method of receiving one or more patterns of neurostimulation pulses as taught by Giuffrida. One of ordinary skill in the art would have been motivated to make these modifications to improve therapeutic benefit by varying stimulation parameters [0310]. Regarding claim 15, Giuffrida & Buddha teach the method of claim 14, and Buddha further teaches a method wherein receiving the one or more patterns of neurostimulation pulses comprises receiving one or more dynamic patterns of neurostimulation each including at least one stimulation parameter of the multiple stimulation parameters being modulated by a modulating waveform ([0305-0306]; frequency and amplitude stimulation waveforms modulated with a carrier waveform at a carrier frequency given modulation parameters). 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 method of Giuffrida & Buddha with the method of receiving one or more dynamic patterns of neurostimulation including modulating at least one stimulation parameter by a modulating waveform as further taught by Buddha. One of ordinary skill in the art would have been motivated to make these modifications to improve therapeutic benefit by varying stimulation parameters [0310]. Regarding claim 16, Giuffrida and Buddha teach the method of claim 15, and Buddha further teaches a method wherein the at least one stimulation parameter being modulated by the modulating waveform comprises at least one of a pulse amplitude, a pulse width, or a pulse frequency that is modulated with a modulation depth and modulation frequency, and generating the information for programming the stimulation device comprises setting the modulation depth to a value between 0% and 40% and setting the modulation frequency to a value between 0.5 Hz and 1.1 Hz ([0306]; amplitude modulated (AM) pulses with carrier frequency of 1 Hz and modulation depth of 33%). 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 method of Giuffrida and Buddha with the pulse amplitude that is modulated with a modulation depth between 0% and 40% and modulation frequency between 0.5 Hz and 1.1 Hz as further taught by Buddha, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05). Regarding claim 17, Giuffrida & Buddha teach the method of claim 14, and Buddha further teaches wherein the one or more first stimulation parameters comprise a pulse frequency [0262]. 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 method of Giuffrida & Buddha wherein the one or more first stimulation parameters comprise a pulse frequency as further taught by Buddha. One of ordinary skill in the art would have been motivated to make these modifications to improve therapeutic benefit by varying stimulation parameters [0310]. Regarding claim 18, Giuffrida & Buddha teach the method of claim 17, but do not disclose wherein generating the information for programming the stimulation device comprises setting the pulse frequency to a value between 20 Hz and 30 Hz as claimed. However, Buddha teaches a method wherein generating the information for programming the stimulation device comprises setting the pulse frequency to a value between 5 Hz and 25 Hz ([0262]; apparatus (10) configured to deliver overlapping pulse frequency range; [0180]; controller (250) provides a pulse frequency range between 10 Hz and 500 Hz). 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 method of Giuffrida & Buddha with the pulse frequency range between 20 Hz and 30 Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05). Regarding claim 19, Giuffrida and Buddha teach the method of claim 14, and Buddha further teaches wherein the one or more first stimulation parameters comprise a pulse width [0308]. 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 method of Giuffrida & Buddha wherein the one or more first stimulation parameters comprise a pulse width as taught by Buddha. One of ordinary skill in the art would have been motivated to make these modifications to improve therapeutic benefit by varying stimulation parameters [0310]. Regarding claim 20, Giuffrida & Buddha teach the method of claim 19, but do not disclose wherein generating the information for programming the stimulation device comprises setting the pulse width to a value between 0.25 ms and 0.4 ms. However, Buddha teaches a method wherein generating the information for programming the stimulation device comprises setting the pulse width to a value between 5 micro seconds and 1 ms ([0308]; pulse width encompasses claimed range). 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 method of Giuffrida & Buddha with the pulse width between 0.25 ms and 0.4 ms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. John (US Patent 12,070,615) discloses a neurostimulation method and system for optimizing stimulation pulse parameters including pulse trains, determined through sensed and patient feedback, using a carrier waveform that can be adjusted with modulation settings. Dynamic modulation or roving, alternates stimulation parameters between a range of values. 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. 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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. /DWANE COLLARD/Examiner, Art Unit 3792 /William J Levicky/Primary Examiner, Art Unit 3796 Application/Control Number: 18/893,364 Page 2 Art Unit: 3792 Application/Control Number: 18/893,364 Page 3 Art Unit: 3792 Application/Control Number: 18/893,364 Page 4 Art Unit: 3792 Application/Control Number: 18/893,364 Page 5 Art Unit: 3792 Application/Control Number: 18/893,364 Page 6 Art Unit: 3792 Application/Control Number: 18/893,364 Page 7 Art Unit: 3792 Application/Control Number: 18/893,364 Page 8 Art Unit: 3792 Application/Control Number: 18/893,364 Page 9 Art Unit: 3792 Application/Control Number: 18/893,364 Page 10 Art Unit: 3792 Application/Control Number: 18/893,364 Page 11 Art Unit: 3792 Application/Control Number: 18/893,364 Page 12 Art Unit: 3792 Application/Control Number: 18/893,364 Page 13 Art Unit: 3792 Application/Control Number: 18/893,364 Page 14 Art Unit: 3792 Application/Control Number: 18/893,364 Page 15 Art Unit: 3792 Application/Control Number: 18/893,364 Page 16 Art Unit: 3792 Application/Control Number: 18/893,364 Page 17 Art Unit: 3792 Application/Control Number: 18/893,364 Page 18 Art Unit: 3792 Application/Control Number: 18/893,364 Page 19 Art Unit: 3792 Application/Control Number: 18/893,364 Page 20 Art Unit: 3792 Application/Control Number: 18/893,364 Page 21 Art Unit: 3792 Application/Control Number: 18/893,364 Page 22 Art Unit: 3792 Application/Control Number: 18/893,364 Page 23 Art Unit: 3792 Application/Control Number: 18/893,364 Page 24 Art Unit: 3792 Application/Control Number: 18/893,364 Page 25 Art Unit: 3792 Application/Control Number: 18/893,364 Page 26 Art Unit: 3792
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