DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 4/3/2026 with respect to the rejection of claim 6 under 35 USC 112 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments regarding the rejection of Independent Claims 1, 19 and 20 under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0280500 A1 to Skelton et al. (“Skelton”) have been fully considered and are persuasive. The Examiner agrees that Skeleton does not disclose or suggest that Skelton’s first function of time is “analyzed at the external device” “to determine a periodic variation as a function of time and a non-periodic trend as a function of time” as required by the independent Claims as amended. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of CN 108392735 A.
Applicant’s arguments regarding dependent Claims 2-8 and 11-18 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive as explained above. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of CN 108392735 A.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-9, 11-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2010/0280500 A1 to Skelton et al. (“Skelton”) in view of CN 108392735 A (“CN ‘735”).
Regarding Independent Claim 1, Skelton teaches:
A method using an external device for controlling a stimulator device that provides stimulation to a patient, the method comprising: (Para. [0058], “Referring still to FIG. 1A, a user, such as a clinician or patient 12, may interact with a user interface of external programmer 20 to program IMD 14. Programming of IMD 14 may refer generally to the generation and transfer of commands, programs, or other information to control the operation of IMD 14. For example, external programmer 20 may transmit programs, parameter adjustments, program selections, group selections, or other information to control the operation of IMD 14, e.g., by wireless telemetry. As one example, external programmer 20 may transmit parameter adjustments to support therapy modifications relating to changes in the posture state of patient 12 at particular times of day;” Para. [0060], “If a user adjusts a given therapy at a given time of the day for a given posture, via external programmer 20, IMD 14 (or programmer 20) may be configured to store the configuration defined by the adjustment;” Paras. [0226] through [0230]; Para. [0230], “Thus, according to the process of FIG. 12, IMD 14 can receive patient feedback that defines or adjusts therapy;” Fig. 12, “Receive Therapy Adjustment From Programmer to Define New Therapy Parameters for IMD 220”);
receiving at the external device a plurality of adjustments to a stimulation parameter of the stimulation provided by the stimulator device, (Para. [0058], “Referring still to FIG. 1A, a user, such as a clinician or patient 12, may interact with a user interface of external programmer 20 to program IMD 14. Programming of IMD 14 may refer generally to the generation and transfer of commands, programs, or other information to control the operation of IMD 14. For example, external programmer 20 may transmit programs, parameter adjustments, program selections, group selections, or other information to control the operation of IMD 14, e.g., by wireless telemetry. As one example, external programmer 20 may transmit parameter adjustments to support therapy modifications relating to changes in the posture state of patient 12 at particular times of day;” Para. [0060], “If a user adjusts a given therapy at a given time of the day for a given posture, via external programmer 20, IMD 14 (or programmer 20) may be configured to store the configuration defined by the adjustment;” Paras. [0226] through [0230]; Para. [0230], “Thus, according to the process of FIG. 12, IMD 14 can receive patient feedback that defines or adjusts therapy;” Fig. 12, “Receive Therapy Adjustment From Programmer to Define New Therapy Parameters for IMD 220”);
wherein the plurality of adjustments comprises a first function of time; (Para. [0058], “As one example, external programmer 20 may transmit parameter adjustments to support therapy modifications relating to changes in the posture state of patient 12 at particular times of day.”);
In accordance with the Present Specification (see, e.g., Present Specification at Paras. [0048] and [0049]), the term “function of time” is being interpreted to simply require time dependence for a given event, e.g., a time at which an amplitude adjustment is made. Skelton’s external programmer “transmit[s] parameter adjustments to support therapy modifications relating to changes in the posture state of patient 12 at particular times of day” (Skelton at Para. [0058]). That these adjustments are made at a particular time of day renders them “a function of time.” Skelton thus discloses “wherein the plurality of adjustments comprises a first function of time.”
…determine a periodic variation as a function of time and a non-periodic trend as a function of time, and to determine a forecasted stimulation parameter as a function of time using both the periodic variation and the non-periodic trend; (Para. [0060], “In some aspects of this disclosure, an external programmer 20 may facilitate automatic learning of posture and timing-responsive therapy by IMD 14. If a user adjusts a given therapy at a given time of the day for a given posture, via external programmer 20, IMD 14 (or programmer 20) may be configured to store the configuration defined by the adjustment. Then, in a subsequent day, at the same given time if the same given posture is detected, IMD 14 may automatically adjust to the configuration that was selected by the user on the previous day;” Para. [0081], “In accordance with this disclosure, the ability to automate therapy based on posture state and timing may occur solely in IMD 14, may occur in IMD 14 in response to an initial programming of therapy by programmer 30, may occur in IMD 14 in response to automated time-controlled programming sessions initiated by programmer 30, or may occur in IMD in response to therapy adjustments by the user via programmer 30;” Fig. 12, “Detect Posture State Via IMD 222,” “Detect Timing Associated With Detected Posture State 224” and “Associate New Therapy Parameters With The Detected Posture State and the Timing 226;” Paras. [0226] through [0230]);
and automatically controlling the stimulator device over time to provide the stimulation in accordance with the forecasted stimulation parameter. (Para. [0055], “A processor within IMD 14 (or possibly within the programmer) may cause automatic adjustments to stimulation according to the detected posture state and timing;” Para. [0229], “If processor 80 determines that IMD 14 has detected the same posture state and the same timing (e.g., the same time of day) in a subsequent day (“yes” 231), processor 80 automatically adjusts the IMD to deliver the new therapy parameters (232) and causes IMD 14 to deliver therapy according to the new therapy parameters (234); Fig. 12, “Deliver Therapy to a Patient According to New Therapy Parameters;” Paras. [0226] through [0230]).
Skelton does not disclose:
analyzing at the external device the first function of time to determine…
That is, Skelton determines Skelton’s “non-periodic trend as a function of time” by analyzing discrete data points (i.e., historical times at which a patient has made an adjustment) rather than by analyzing the same “a first function of time” from which Skelton’s “periodic variation as a function of time” is derived.
CN ‘735 describes “…an electrical stimulation adjustment method…” (Abstract). CN ‘735 is analogous art.
CN ‘735 teaches:
analyzing at the external device the first function of time to determine… (Abstract, “The present invention is applicable to the technical field of wearable devices, and provides an electrical stimulation adjustment method, device, and wearable device, including: acquiring the data of the start time of pain generated by the user, and the output of the wearable device when the user uses the wearable device to relieve the pain. The historical output data of electrical stimulation signals; by analyzing the pain trend of the starting time data, the estimated time of the user's next pain is obtained; the user characteristics of the user are determined by analyzing the historical output data; based on the estimated time and user characteristics, the electrical stimulation mode corresponding to the user in the wearable device is used to adjust the electrical stimulation parameters. ;” Claims 1-2).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Skelton with the teachings of CN ‘735 (i.e., to modify the method of Skelton such that the same “a first function of time” from which Skelton’s “periodic variation as a function of time” is derived is analyzed to determine Skelton’s “non-periodic trend as a function of time” instead of analyzing discrete data points stored in memory representing historical times at which a patient has made an adjustment) in order to provide a more accurate and reliable pain relief (CN ‘735 at Abstract).
Regarding Claim 4, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the adjusted stimulation parameter and the forecasted stimulation parameter comprise a stimulation amplitude (Para. [0056], “In response to a posture state indication by the posture state module at specific times of day, IMD 14 may change program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy.”).
Regarding Claim 5, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the forecasted stimulation parameter comprises a sum of the periodic variation and the non-periodic trend (Para. [0058], “A group may be characterized by multiple programs that are delivered simultaneously or on an interleaved or rotating basis;” see also Para. [0108]).
Skelton’s simultaneous delivery of multiple programs is such “a sum of the periodic variation and the non-periodic trend” as claimed.
Regarding Claim 6, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
CN ‘375 additionally teaches:
wherein the forecasted stimulation parameter comprises a product of the periodic variation and the non-periodic trend (CN ‘375 Machine Translation at Pg. 7/12, Tenth Paragraph, “For example, assuming that the intensity incremental adjustment coefficient set in the electrical stimulation mode is 2V/hour, and the actual stimulation duration is divided by the set stimulation duration to calculate the ratio and the intensity incremental adjustment coefficient is 0.5, then use the intensity incremental adjustment Multiply the coefficient by the set intensity progressive change coefficient to get the latest intensity gradual change coefficient is 2V/hour*0.5=1V/hour.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of combined Skelton and CN ‘735 with the teachings of Skelton (i.e., to use such a forecasted stimulation parameter comprising a product of the periodic variation and the non-periodic trend as taught by CN ‘735) in order to account for user tolerance (CN ‘735 Machine Translation at Pg. 7/12, 7th Paragraph through 10th Paragraph).
Regarding Claim 7, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the forecasted stimulation parameter further comprises a time-invariant level (Para. [0103], “An exemplary range of electrical stimulation parameters likely to be effective in treating chronic pain, e.g., when applied to spinal cord 18, are listed below. While stimulation pulses are described, stimulation signals may be of any of a variety of forms such as sine waves or the like;” Para. [0104], “1. Pulse Rate: between approximately 0.5 Hz and approximately 1200 Hz…;” Para. [0105], “2. Amplitude: between approximately 0.1 volts and approximately 50 volts, more preferably between approximately 0.5 volts and approximately 20 volts, and still more preferably between approximately 1 volt and approximately 10 volts. In other examples, a current amplitude may be defined as the biological load in the voltage that is delivered;” Para. [0106], “3. Pulse Width: between approximately 10 microseconds and approximately 5000 microseconds…”).
Skelton’s above-noted ranges do not depend on time, and are thus “time-invariant” as claimed. Skelton’s ranges are “levels” when the term is afforded its broadest reasonable interpretation.
Regarding Claim 8, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 7 as explained above.
Skelton additionally discloses:
wherein the forecasted stimulation parameter comprises a function of the periodic variation, the non-periodic trend, and the time-invariant level (Paras. [0060], [0081] and [0103] through [0106]).
Skelton’s forecasted stimulation parameter is kept within the above-noted ranges. Skelton’s forecasted stimulation parameter is “a function of” those ranges when the term is afforded its broadest reasonable interpretation as the ranges act as limits.
Skelton’s forecasted stimulation parameter is a function of Skelton’s periodic variation and non-periodic trend as Skelton’s forecasted stimulation parameter is forecast based on those items.
Regarding Claim 9, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the external device comprises a portable patient external controller (Para. [0059], “In other cases, external programmer 20 may be characterized as a patient programmer if it is primarily intended for use by a patient. A patient programmer is generally accessible to patient 12 and, in many cases, may be a portable device that may accompany the patient throughout the patient's daily routine.”).
Regarding Claim 11, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the external device transmits the forecasted stimulation parameter to the stimulator device to automatically control the stimulator device in accordance with the forecasted stimulation parameter (Paras. [0058], [0060], and [0229]).
Regarding Claim 12, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the stimulator device is automatically controlled in accordance with the forecasted stimulation parameter by adjusting that stimulation parameter at the stimulator device as a function of time (Para. [0081], “In accordance with this disclosure, the ability to automate therapy based on posture state and timing may occur solely in IMD 14, may occur in IMD 14 in response to an initial programming of therapy by programmer 30, may occur in IMD 14 in response to automated time-controlled programming sessions initiated by programmer 30, or may occur in IMD in response to therapy adjustments by the user via programmer 30.”).
Regarding Claim 13, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the adjustments to the stimulation parameter are received at a user interface of the external device (Para. [0058], “Referring still to FIG. 1A, a user, such as a clinician or patient 12, may interact with a user interface of external programmer 20 to program IMD 14.”).
Regarding Claim 14, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 13 as explained above.
Skelton additionally discloses:
wherein the user interface comprises a selectable option to cause the external device to automatically control the stimulator device to provide the stimulation in accordance with the forecasted stimulation parameter (Para. [0080], “When patient 12 enters an automatic posture response screen of the user interface, pressing sync button 58 turns on the automatic posture response to allow IMD 14 to automatically change therapy according to the posture state of patient 12 at various times of the day.”).
Regarding Claim 15, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 13 as explained above.
Skelton additionally discloses:
further comprising overriding automatic control of the stimulator device by receiving at least one input at the user interface to manually control the stimulation parameter (Para. [0080], “Pressing sync button 58 again, when the automatic posture response screen is displayed, turns off the automatic posture response.”).
Regarding Claim 17, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the stimulator device provides the stimulation as electrical stimulation at one or more electrodes of the stimulator device (Para. [0044], “IMD 14 delivers electrical stimulation therapy to patient 12 via selected combinations of electrodes carried by one or both of leads 16.”).
Regarding Claim 18, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
Skelton additionally discloses:
wherein the stimulator device is implantable in the patient (Para. [0061], “IMD 14 may be constructed with a biocompatible housing, such as titanium or stainless steel, or a polymeric material such as silicone or polyurethane, and surgically implanted at a site in patient 12, e.g., near the pelvis. IMD 14 may also be implanted in patient 12 at other locations, preferably in locations that would be minimally noticeable to patient 12.”).
Regarding Independent Claim 19, Skelton discloses:
A system, comprising: (Title, “Medical device therapy based on posture and timing”);
an external device for controlling a stimulator device that provides stimulation to a patient, (Para. [0058]);
the external device comprising: a user interface (Para. [0058], “Referring still to FIG. 1A, a user, such as a clinician or patient 12, may interact with a user interface of external programmer 20 to program IMD 14.”);
configured to receive a plurality of adjustments to a stimulation parameter of the stimulation provided by the stimulator device, (Paras. [0058] and [0060]); Paras. [0226] through [0230]; Fig. 12, “Receive Therapy Adjustment From Programmer to Define New Therapy Parameters for IMD 220”);
wherein the plurality of adjustments comprises a first function of time; (Para. [0058], “As one example, external programmer 20 may transmit parameter adjustments to support therapy modifications relating to changes in the posture state of patient 12 at particular times of day.”);
This limitation is being interpreted similarly to the similar limitation of Claim 1. See explanation at Claim 1, above.
and controller circuitry programmed with an algorithm, wherein the algorithm is configured to: … determine a periodic variation as a function of time and a non-periodic trend as a function of time, and to determine a forecasted stimulation parameter as a function of time using both the periodic variation and the non-periodic trend, (Paras. [0060] and [0081]; Paras. [0226] through [0230]; Fig. 12, “Detect Posture State Via IMD 222,” “Detect Timing Associated With Detected Posture State 224” and “Associate New Therapy Parameters With The Detected Posture State and the Timing 226”);
and automatically control the stimulator device over time to provide the stimulation in accordance with the forecasted stimulation parameter. (Para. [0055]; Paras. [0226] through [0230]; Fig. 12, “Deliver Therapy to a Patient According to New Therapy Parameters).
Skelton does not disclose:
analyze the first function of time to determine
That is, Skelton determines Skelton’s “non-periodic trend as a function of time” by analyzing discrete data points (i.e., historical times at which a patient has made an adjustment) rather than by analyzing the same “a first function of time” from which Skelton’s “periodic variation as a function of time” is derived.
CN ‘735 describes “…an electrical stimulation adjustment method…” (Abstract). CN ‘735 is analogous art.
CN ‘735 teaches:
analyzing at the external device the first function of time to determine… (Abstract, “The present invention is applicable to the technical field of wearable devices, and provides an electrical stimulation adjustment method, device, and wearable device, including: acquiring the data of the start time of pain generated by the user, and the output of the wearable device when the user uses the wearable device to relieve the pain. The historical output data of electrical stimulation signals; by analyzing the pain trend of the starting time data, the estimated time of the user's next pain is obtained; the user characteristics of the user are determined by analyzing the historical output data; based on the estimated time and user characteristics, the The electrical stimulation mode corresponding to the user in the wearable device is used to adjust the electrical stimulation parameters.. ;” Claims 1-2).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Skelton with the teachings of CN ‘735 (i.e., to modify the method of Skelton such that the same “a first function of time” from which Skelton’s “periodic variation as a function of time” is derived is analyzed to determine Skelton’s “non-periodic trend as a function of time” instead of analyzing discrete data points stored in memory representing historical times at which a patient has made an adjustment) in order to provide a more accurate and reliable pain relief (CN ‘735 at Abstract).
Regarding Independent Claim 20, Skelton teaches:
A non-transitory computer readable medium (Para. [0009], “If implemented in software, this disclosure may be directed to a computer readable storage medium comprising instructions that when executed in a medical device system cause the medical device system to detect a posture state of a patient via a medical device of the medical device system….”);
comprising instructions executable on an external device for controlling a stimulator device that provides stimulation to a patient, (Para. [0058]);
wherein the instructions when executed enable the external device to: receive a plurality of adjustments to a stimulation parameter of the stimulation provided by the stimulator device, (Paras. [0058] and [0060]); Paras. [0226] through [0230]; Fig. 12, “Receive Therapy Adjustment From Programmer to Define New Therapy Parameters for IMD 220”);
wherein the plurality of adjustments comprises a first function of time;(Para. [0058], “As one example, external programmer 20 may transmit parameter adjustments to support therapy modifications relating to changes in the posture state of patient 12 at particular times of day.”);
This limitation is being interpreted similarly to the similar limitation of Claim 1. See explanation at Claim 1, above.
… determine a periodic variation as a function of time and a non-periodic trend as a function of time, and to determine a forecasted stimulation parameter as a function of time using both the periodic variation and the non-periodic trend (Paras. [0060] and [0081]; Paras. [0226] through [0230]; Fig. 12, “Detect Posture State Via IMD 222,” “Detect Timing Associated With Detected Posture State 224” and “Associate New Therapy Parameters With The Detected Posture State and the Timing 226”);
This limitation is being interpreted similarly to the similar limitation of Claim 1. See explanation at Claim 1, above.
wherein the forecasted stimulation parameter comprises a periodic variation as a function of time or a non-periodic trend as a function of time; (Para. [0229]);
This limitation is being interpreted similarly to the similar limitation of Claim 1. See explanation at Claim 1, above.
and automatically control the stimulator device over time to provide the stimulation in accordance with the forecasted stimulation parameter (Para. [0055]; Paras. [0226] through [0230]; Fig. 12, “Deliver Therapy to a Patient According to New Therapy Parameters).
Skelton does not disclose:
analyze the first function of time to determine…
That is, Skelton determines Skelton’s “non-periodic trend as a function of time” by analyzing discrete data points (i.e., historical times at which a patient has made an adjustment) rather than by analyzing the same “a first function of time” from which Skelton’s “periodic variation as a function of time” is derived.
CN ‘735 describes describes “…an electrical stimulation adjustment method…” (Abstract). CN ‘735 is analogous art.
CN ‘735 teaches:
analyzing at the external device the first function of time to determine… (Abstract, “The present invention is applicable to the technical field of wearable devices, and provides an electrical stimulation adjustment method, device, and wearable device, including: acquiring the data of the start time of pain generated by the user, and the output of the wearable device when the user uses the wearable device to relieve the pain. The historical output data of electrical stimulation signals; by analyzing the pain trend of the starting time data, the estimated time of the user's next pain is obtained; the user characteristics of the user are determined by analyzing the historical output data; based on the estimated time and user characteristics, the The electrical stimulation mode corresponding to the user in the wearable device is used to adjust the electrical stimulation parameters;” Claims 1-2).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Skelton with the teachings of CN ‘735 (i.e., to modify the method of Skelton such that the same “a first function of time” from which Skelton’s “periodic variation as a function of time” is derived is analyzed to determine Skelton’s “non-periodic trend as a function of time” instead of analyzing discrete data points stored in memory representing historical times at which a patient has made an adjustment) in order to provide a more accurate and reliable pain relief (CN ‘735 at Abstract).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2010/0280500 A1 to Skelton et al. (“Skelton”) in view of CN 108392735 A (“CN ‘735”) as applied to Claim 1 above, and further in view of previously cited Jason Brownlee, "A Gentle Introduction to SARIMA for Time Series Forecasting in Python," Machine Learning Mastery, https://machinelearningmastery.com/sarima-for-time-series-forecasting-in-python/, August 21, 2019 (Accessed 9/9/2024).
Regarding Claim 2, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 1 as explained above.
The combination of Skelton and CN ‘735 does not disclose:
wherein analyzing the adjustment to the stimulation parameter comprises use of a time series analysis algorithm
Brownlee describes a “method for time series forecasting with univariate data containing trends and seasonality” (Brownlee at Pg. 1, Fourth Paragraph). Brownlee is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
The problem faced by the inventor is to alleviate a stimulation patient’s burden of “hav[ing] to constantly adjust the amplitude of stimulation to address various changes (e.g., patient activity or posture, curative effects, formation of scar tissue, etc.)” (Present Specification at Para. [0046]) “by allowing the stimulation system to make automatic adjustments to the stimulation” given that “[the] patient likely follows a somewhat predictable routine during the day, and this is reflected in the amplitudes the patient has selected” (Present Specification at Para. [0045]). In other words, the problem faced by the inventor is how to use past stimulation adjustments to forecast the need for future such adjustments.
Brownlee pertains to a “method for time series forecasting with univariate data containing trends and seasonality” (Brownlee at Pg. 1, Fourth Paragraph). Such a method as described by Brownlee would logically have commended itself to an inventor's attention in considering his problem, because Brownlee’s method yields precisely such a forecast as the inventor’s problem requires. Brownlee is thus analogous art. See MPEP 2141.01(a)(I).
Brownlee discloses:
wherein analyzing the adjustment to the stimulation parameter comprises use of a time series analysis algorithm (Brownlee at Pg. 1, Fourth Paragraph).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Skelton and CN ‘735 with the teachings of Brownlee (i.e., to use in place of Skelton’s unspecified algorithm such a time series analysis algorithm as taught by Brownlee) because such a modification entails only a simple substitution of one known element for another.
The prior art contains a method (i.e., that described by Skelton) that differs from the claimed method by the substitution of some components (i.e., Skelton’s unspecified algorithm) with other components (i.e., a time series analysis algorithm).
The substituted components (i.e., a time series analysis algorithm) are known in the art. For example, Brownlee describes such an algorithm.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Such a substitution is similar to that at issue in Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 87 USPQ2d1350 (Fed. Cir. 2008) and Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 82 USPQ2d 1687 (Fed. Cir. 2007) as described at MPEP 2143(I)(B), Example 7. Similarly to both Muniauction and Leapfrog, market pressures would have prompted a person of ordinary skill to use a popular data forecasting algorithm for forecasting parameters.
Regarding Claim 3, the combination of Skelton, CN ‘735 and Brownlee renders obvious the entirety of Claim 2 as explained above.
Brownlee additionally discloses:
wherein the time series analysis algorithm comprises a seasonal autoregressive integrated moving average algorithm (Brownlee at Pg. 1, Fourth Paragraph, “In this tutorial, you will discover the Seasonal Autoregressive Integrated Moving Average, or SARIMA, method for time series forecasting with univariate data containing trends and seasonality.”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2010/0280500 A1 to Skelton et al. (“Skelton”) in view of CN 108392735 A (“CN ‘735”) as applied to Claim 1 above, and further in view of previously cited US 2020/0353269 A1 to Agnesi et al. (“Agnesi”).
Regarding Claim 16, the combination of Skelton and CN ‘735 renders obvious the entirety of Claim 13 as explained above.
The combination of Skelton and CN ‘735 does not disclose:
further comprising reverting to automatic control of the stimulator device a time period after manual control of the stimulation parameter
Agnesi describes “…identifying or otherwise programming one or more cycling parameters for operation of an implantable pulse generator to provide a neurostimulation therapy to a patient using a non-paresthesia stimulation pattern” (Abstract). Agnesi is thus analogous art.
Agnesi discloses:
further comprising reverting to automatic control of the stimulator device a time period after manual control of the stimulation parameter (Para. [0014], “In some embodiments, the bolus mode of operation is limited to a predetermined amount of time. In some embodiments, the implantable pulse generator automatically reverts to the regular mode of operation from the bolus mode of operation at an end of the predetermined amount of time.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Skelton and CN ‘735 with the teachings of Agnesi (i.e., to modify the method of Skelton such that it additionally includes reverting to automatic control of the stimulator device a time period after manual control of the stimulation parameter in the manner taught by Agnesi) because such a modification is use of a known technique to improve a similar method in the same way.
The prior art contained a base method upon which the claimed invention can be seen as an improvement. Specifically, the invention of Claim 16 (i.e., reverting to automatic control of the stimulator device a time period after manual control of the stimulation parameter) can be seen as an improvement to the method of Skelton, which does not include such automatic reverting.
The prior art contain a comparable method that has been improved in the same way as the claimed invention. Specifically, Agnesi’s “implantable pulse generator automatically revert[ing] to the regular mode of operation from the bolus mode of operation at an end of the predetermined amount of time” is such a comparable method that has been improved in the same way as the claimed invention.
One of ordinary skill in the art could have applied the known improvement technique in the same way to the base method and the results would have been predictable to one of ordinary skill in the art
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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