CTNF 18/905,879 CTNF 95490 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 5 is objected to because of the following informalities: i. Regarding Claim 5, the limitation “wherein the producing the missing data using includes the at least one of the neurostimulation device and the programmer producing the missing data using” is grammatically incorrect. Based on the similar Claim 16, the Examiner presumes it should read “wherein producing the missing data includes using one or more of…” Appropriate correction is required. 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 5 and 13 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. Regarding Claims 5 and 13, the claims are indefinite because they merely recite a use without any active, positive steps delimiting how this use is actually practiced. Claims 5 and 13 define that the missing data is produced using one or more of an algorithm, but don’t specify how the one or more algorithms produce the missing data. “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim” (MPEP 2173.05(q)). 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. 07-15 AIA Claim s 1-4, 7-12, and 15-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by U.S. Patent Publication 20190038902 awarded to Kaemmerer et al . Regarding Claim 1, Kaemmerer teaches a computer-implemented method of operating a neurostimulation system (Para. 0002), the method comprising: delivering neurostimulation to a subject using a neurostimulation device of the neurostimulation system when the neurostimulation device is connected to an implantable stimulation lead (IMD 16, Fig. 1, Para. 0027); recording electrical signals sensed using the implantable stimulation lead (Para. 0039, “In other examples, IMD 16 is configured to deliver electrical stimulation therapy to brain 28 of patient 12 in a closed loop manner, in which IMD 16 controls the timing of the delivery of electrical stimulation to brain 28, the output parameters of the electrical stimulation, or both based on one or more of user input and input from one or more sensing sources. The sensing sources may, for example, provide feedback that may be used to control the electrical stimulation output from IMD 16. For instance, therapy system 10 is an example of an autonomous adaptive system that delivers therapy to patient 12 in a manner that varies in real time according to sense information about patient 12”); detecting and correcting errors in a recorded electrical signal to produce a corrected recorded electrical signal (Para. 0023, “The medical device may be configured to replace the missing or out-of-band samples, which may result in reduction of unnecessary therapy adjustment. One example way in which the medical device may replace missing or out-of-band samples is to interpolate values based on valid samples. As an example, the medical device may utilize linear interpolation with one or more preceding samples to the missing or out-of-band samples and with one or more subsequent samples to the missing or out-of-band samples to generate interpolated sample values that replace (e.g., fill-in) the missing or out-of-band sample values. For instance, the medical device may interpolate sensor data values in error locations (e.g., missing or out-of-band samples) based on sensor data values in non-error locations of the sensor data”); and adjusting a device-based neurostimulation therapy provided to the subject using the corrected recorded electrical signal (Para. 0113, “In general, application 88 may cause processing circuit 60 to repeatedly determine whether the confidence levels are compliant with conditions of rules until the confidence levels are compliant with conditions of a rule. Processing circuit 60 may determine a set of available therapy parameter values associated with the rule, and determine the one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 2, Kaemmerer teaches the method of claim 1, wherein the detecting and correcting errors in the recorded electrical signal includes at least one of the neurostimulation device and a programmer of the neurostimulation device detecting incorrect data and removing the incorrect data from the recorded electrical signal (Para. 0023, “The medical device may be configured to replace the missing or out-of-band samples, which may result in reduction of unnecessary therapy adjustment. One example way in which the medical device may replace missing or out-of-band samples is to interpolate values based on valid samples. As an example, the medical device may utilize linear interpolation with one or more preceding samples to the missing or out-of-band samples and with one or more subsequent samples to the missing or out-of-band samples to generate interpolated sample values that replace (e.g., fill-in) the missing or out-of-band sample values. For instance, the medical device may interpolate sensor data values in error locations (e.g., missing or out-of-band samples) based on sensor data values in non-error locations of the sensor data”). Regarding Claim 3, Kaemmerer teaches the method of claim 2, wherein the removing the incorrect data includes the at least one of the neurostimulation device and the programmer applying a signal smoothing algorithm to the recorded electrical signal (Para. 0087, “There may be various algorithms to interpolate. As one example, processing circuit 60, via application 84, may interpolate based on sensor data values (e.g., sample values) in non-error locations of the sensor data to generate interpolated data values. For instance, processing circuit 60 may interpolate sensor data values in the error locations based on sensor data values in non-error locations of the sensor data. The interpolations may be linear interpolation (e.g., average of sensor data value of immediately preceding non-error location relative to error location and sensor data value of immediately subsequent non-error location relative to error location) but other interpolation techniques may be possible”). Regarding Claim 4, Kaemmerer teaches the method of claim 1, wherein the detecting and correcting errors in the recorded electrical signal includes at least one of the neurostimulation device and a programmer of the neurostimulation device detecting missing data in the recorded electrical signal and producing the missing data using a data interpolation algorithm ( Para. 0087, “There may be various algorithms to interpolate. As one example, processing circuit 60, via application 84, may interpolate based on sensor data values (e.g., sample values) in non-error locations of the sensor data to generate interpolated data values. For instance, processing circuit 60 may interpolate sensor data values in the error locations based on sensor data values in non-error locations of the sensor data. The interpolations may be linear interpolation (e.g., average of sensor data value of immediately preceding non-error location relative to error location and sensor data value of immediately subsequent non-error location relative to error location) but other interpolation techniques may be possible”). Regarding Claim 7, Kaemmerer teaches the method of claim 1, including: extracting one or more features from the corrected recorded electrical signal, detecting an error in the one or more extracted features of the corrected recorded electrical signal, and removing the one or more extracted features having the detected error or correcting the error in the one or more extracted features (Para. 0097, “To determine which control policies in rules and control policies 76 are available, processing circuit 60, via application 88, may repeatedly determine whether the one or more confidence levels are compliant with one or more conditions of the plurality of rules in rules and control policies 76 until the one or more confidence levels are compliant with one or more conditions of a rule of the plurality of rules (e.g., until condition or conditions of a rule are satisfied). Processing circuit 60, via application 88, may determine a set of available therapy parameter values associated with a rule. For example, processing circuit 60, via application 88, may determine which control policies are associated with the rule, and determine which set of therapy parameter values define the available control policies. In this example, processing circuit 60, via application 88, may determine one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 8, Kaemmerer teaches the method of claim 1, including: extracting one or more features from the corrected recorded electrical signal, and identifying, by at least one of the neurostimulation device and a programmer for the neurostimulation device, an evoked response signal of interest from among the recorded electrical signals using the one or more extracted features of the corrected recorded electrical signal (Para. 0097, “To determine which control policies in rules and control policies 76 are available, processing circuit 60, via application 88, may repeatedly determine whether the one or more confidence levels are compliant with one or more conditions of the plurality of rules in rules and control policies 76 until the one or more confidence levels are compliant with one or more conditions of a rule of the plurality of rules (e.g., until condition or conditions of a rule are satisfied). Processing circuit 60, via application 88, may determine a set of available therapy parameter values associated with a rule. For example, processing circuit 60, via application 88, may determine which control policies are associated with the rule, and determine which set of therapy parameter values define the available control policies. In this example, processing circuit 60, via application 88, may determine one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 9, Kaemmerer teaches a programming device (memory 62 containing therapy programs 72, Para. 0072, Fig. 2) for a neurostimulation device (IMD 16, Fig. 2) that provides electrical neurostimulation to a subject (Para. 0027) according to at least one neurostimulation therapy parameter when coupled to an implantable stimulation lead (Para. 0072), the programming device comprising: a communication circuit configured to receive a recorded electrical signal from the neurostimulation device and send the at least one therapy parameter to the neurostimulation device (telemetry circuit 70, Fig. 2, Para. 0103); and signal processing circuitry configured to: detect and correct errors in the recorded electrical signal to produce a corrected recorded electrical signal (interpolation application 84, Fig. 2, Para. 0110, “In addition, processing circuit 60, via application 82, may identify which sample values for the sensor data are invalid and/or valid. In some examples, processing circuit 60 may execute interpolation application 84 to generate interpolated values that fill in for the invalid data. Processing circuit 60, via application 84, may identify sample values that were interpolated/extrapolated”); and determine a value of the at least one therapy parameter using the corrected recorded electrical signal (Para. 0113, “In general, application 88 may cause processing circuit 60 to repeatedly determine whether the confidence levels are compliant with conditions of rules until the confidence levels are compliant with conditions of a rule. Processing circuit 60 may determine a set of available therapy parameter values associated with the rule, and determine the one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 10, Kaemmerer teaches the programming device of claim 9, wherein the signal processing circuitry is configured to detect incorrect data in the recorded electrical signal and remove the incorrect data from the recorded electrical signal to produce the corrected recorded electrical signal (Para. 0110). Regarding Claim 11, Kaemmerer teaches the programming device of claim 10, wherein the signal processing circuitry is configured to perform a signal smoothing algorithm on the recorded electrical signal to produce the corrected recorded electrical signal (Para. 0087, “There may be various algorithms to interpolate. As one example, processing circuit 60, via application 84, may interpolate based on sensor data values (e.g., sample values) in non-error locations of the sensor data to generate interpolated data values. For instance, processing circuit 60 may interpolate sensor data values in the error locations based on sensor data values in non-error locations of the sensor data. The interpolations may be linear interpolation (e.g., average of sensor data value of immediately preceding non-error location relative to error location and sensor data value of immediately subsequent non-error location relative to error location) but other interpolation techniques may be possible”). Regarding Claim 12, Kaemmerer teaches the programming device of claim 9, wherein the signal processing circuitry is configured to detect missing data in the recorded electrical signal and perform a data interpolation algorithm to include the missing data in the corrected recorded electrical signal (Para. 0087, “There may be various algorithms to interpolate. As one example, processing circuit 60, via application 84, may interpolate based on sensor data values (e.g., sample values) in non-error locations of the sensor data to generate interpolated data values. For instance, processing circuit 60 may interpolate sensor data values in the error locations based on sensor data values in non-error locations of the sensor data. The interpolations may be linear interpolation (e.g., average of sensor data value of immediately preceding non-error location relative to error location and sensor data value of immediately subsequent non-error location relative to error location) but other interpolation techniques may be possible”). Regarding Claim 15, Kaemmerer teaches the programming device of claim 9 , wherein the signal processing circuitry is configured to: extract one or more features from the corrected recorded electrical signal; detect an error in the one or more extracted features of the corrected recorded electrical signal; and remove the one or more extracted features having the detected error or correct the error in the one or more extracted features (Para. 0097, “To determine which control policies in rules and control policies 76 are available, processing circuit 60, via application 88, may repeatedly determine whether the one or more confidence levels are compliant with one or more conditions of the plurality of rules in rules and control policies 76 until the one or more confidence levels are compliant with one or more conditions of a rule of the plurality of rules (e.g., until condition or conditions of a rule are satisfied). Processing circuit 60, via application 88, may determine a set of available therapy parameter values associated with a rule. For example, processing circuit 60, via application 88, may determine which control policies are associated with the rule, and determine which set of therapy parameter values define the available control policies. In this example, processing circuit 60, via application 88, may determine one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 16, Kaemmerer teaches the programming device of claim 9, wherein the signal processing circuitry is configured to: extract one or more features from the corrected recorded electrical signal; and identify an evoked response signal of interest from among the recorded electrical signals using the one or more extracted features of the corrected recorded electrical signal (Para. 0097, “To determine which control policies in rules and control policies 76 are available, processing circuit 60, via application 88, may repeatedly determine whether the one or more confidence levels are compliant with one or more conditions of the plurality of rules in rules and control policies 76 until the one or more confidence levels are compliant with one or more conditions of a rule of the plurality of rules (e.g., until condition or conditions of a rule are satisfied). Processing circuit 60, via application 88, may determine a set of available therapy parameter values associated with a rule. For example, processing circuit 60, via application 88, may determine which control policies are associated with the rule, and determine which set of therapy parameter values define the available control policies. In this example, processing circuit 60, via application 88, may determine one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 17, Kaemmerer teaches a neurostimulation device (IMD 16, Para. 0027) comprising: a stimulation circuit configured to deliver electrical neurostimulation to a subject when coupled to an implantable stimulation lead (signal generator circuit 64, Fig. 2, Para. 0076); a sensing circuit configured to sense electrical signals when coupled to the stimulation lead (electrical sensing circuit 66, Fig. 2, Para. 0077); a control circuit operatively coupled to the stimulation circuit and the sensing circuit (processing circuit 60 and memory circuit 62), and configured to initiate delivery of neurostimulation to the subject and record sensed electrical signals resulting from the neurostimulation (Para. 0077); and signal processing circuitry configured to detect and correct errors in a recorded electrical signal to produce a corrected recorded electrical signal (interpolation application 84, Fig. 2, Para. 0110, “In addition, processing circuit 60, via application 82, may identify which sample values for the sensor data are invalid and/or valid. In some examples, processing circuit 60 may execute interpolation application 84 to generate interpolated values that fill in for the invalid data. Processing circuit 60, via application 84, may identify sample values that were interpolated/extrapolated”); wherein the control circuit is configured to adjust a device-based neurostimulation therapy provided to the subject using the corrected recorded electrical signal (Para. 0113, “In general, application 88 may cause processing circuit 60 to repeatedly determine whether the confidence levels are compliant with conditions of rules until the confidence levels are compliant with conditions of a rule. Processing circuit 60 may determine a set of available therapy parameter values associated with the rule, and determine the one or more therapy parameter values based on the determined set of available therapy parameter values”). Regarding Claim 18, Kaemmerer teaches the neurostimulation device of claim 17, wherein the signal processing circuitry is configured to detect incorrect data in the recorded electrical signal and remove the incorrect data from the recorded electrical signal to produce the corrected recorded electrical signal (interpolation application 84, Fig. 2, Para. 0110, “In addition, processing circuit 60, via application 82, may identify which sample values for the sensor data are invalid and/or valid. In some examples, processing circuit 60 may execute interpolation application 84 to generate interpolated values that fill in for the invalid data. Processing circuit 60, via application 84, may identify sample values that were interpolated/extrapolated”). Regarding Claim 19, Kaemmerer teaches the neurostimulation device of claim 17, wherein the signal processing circuitry is configured to detect missing data in the recorded electrical signal and perform a data interpolation algorithm to include the missing data in the corrected recorded electrical signal (interpolation application 84, Fig. 2, Para. 0110, “In addition, processing circuit 60, via application 82, may identify which sample values for the sensor data are invalid and/or valid. In some examples, processing circuit 60 may execute interpolation application 84 to generate interpolated values that fill in for the invalid data. Processing circuit 60, via application 84, may identify sample values that were interpolated/extrapolated”). Regarding Claim 20, Kaemmerer teaches the neurostimulation device of claim 17, wherein the signal processing circuitry is configured to: extract one or more features from the corrected recorded electrical signal; and identify an evoked response signal of interest from among the recorded electrical signals using the one or more extracted features of the corrected recorded electrical signal (Para. 0097, “To determine which control policies in rules and control policies 76 are available, processing circuit 60, via application 88, may repeatedly determine whether the one or more confidence levels are compliant with one or more conditions of the plurality of rules in rules and control policies 76 until the one or more confidence levels are compliant with one or more conditions of a rule of the plurality of rules (e.g., until condition or conditions of a rule are satisfied). Processing circuit 60, via application 88, may determine a set of available therapy parameter values associated with a rule. For example, processing circuit 60, via application 88, may determine which control policies are associated with the rule, and determine which set of therapy parameter values define the available control policies. In this example, processing circuit 60, via application 88, may determine one or more therapy parameter values based on the determined set of available therapy parameter values”) . Claim Rejections - 35 USC § 103 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. 07-20-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 5-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kaemmerer, as taught in Claims 1, 4, 9, and 12 above, in view of U.S. Patent Publication 20190246927 awarded to Vayrynen et al . Regarding Claims 5-6 and 13-14, Kaemmerer teaches the inventions of Claims 1, 4, 9 and 12 above. Kaemmerer does not teach wherein producing the missing data includes using one or more of an expectation-maximization (EM) algorithm, a maximum-likelihood estimation algorithm, a Kalman smoothing algorithm, or low pass filtering of the recorded electrical signal, and further including filtering the corrected recorded electrical signal, using at least one of the neurostimulation device and a programmer for the neurostimulation device, to produce a filtered corrected recorded electrical signal; and detecting and correcting a signal artifact in the filtered corrected recorded electrical signal introduced by the filtering. However, in the art of electric stimulators (Para. 0119), Vayrynen teaches the usage of an expectation-maximization algorithm to perform a first filtering step (Para. 0044), followed by further correcting the signal to remove additional artifacts using either a Kalman estimator or MLE (Para. 0045) to “improve signal-to noise ratio and/or limit or filter out random spikes” (Para. 0045). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaemmerer by Vayrynen, i.e. by using the filtering systems of Vayrynen above, for the predictable purpose of improving the signal quality as set forth in Vayrynen above. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F. 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, Unsu Jung, can be reached at (571)-272-8506. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call (800)-786-9199 (In USA or Canada) or (571)-272-1000. /JLM/ Examiner, Art Unit 3792 /ALLEN PORTER/Primary Examiner, Art Unit 3796 Application/Control Number: 18/905,879 Page 2 Art Unit: 3792 Application/Control Number: 18/905,879 Page 3 Art Unit: 3792 Application/Control Number: 18/905,879 Page 4 Art Unit: 3792 Application/Control Number: 18/905,879 Page 5 Art Unit: 3792 Application/Control Number: 18/905,879 Page 6 Art Unit: 3792 Application/Control Number: 18/905,879 Page 7 Art Unit: 3792 Application/Control Number: 18/905,879 Page 8 Art Unit: 3792 Application/Control Number: 18/905,879 Page 9 Art Unit: 3792 Application/Control Number: 18/905,879 Page 10 Art Unit: 3792 Application/Control Number: 18/905,879 Page 11 Art Unit: 3792 Application/Control Number: 18/905,879 Page 12 Art Unit: 3792 Application/Control Number: 18/905,879 Page 13 Art Unit: 3792 Application/Control Number: 18/905,879 Page 14 Art Unit: 3792
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