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 .
Claim Rejections - 35 USC § 102
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.
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 –
(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.
Claims 1-4, 7-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20170080234 awarded to Gillespie et al, hereinafter Gillespie.
Regarding Claims 1 and 14, Gillespie teaches a system and method for providing electrostimulation to a patient (abstract), comprising: an electrostimulator configured to provide a neuromodulation therapy to a patient (implantable stimulator 4, Para. 0025); and a programmer device operable by a user to program the electrostimulator (programmer 20, Para. 0034), the programmer device including: a user interface (Para. 0034, “Programmer 20 may be a handheld computing device that permits a user to program stimulation therapy for patient 6 via a user interface, e.g., using input keys and a display”); and a controller circuit configured to: collect user commands and contextual information during a programming session including a sequence of programming instructions from the user via the user interface (Para. 0034, “For example, using programmer 20, the clinician may specify stimulation parameters, i.e., create programs, for use in delivery of stimulation therapy”); determine a programming quality indicator using the collected user commands and contextual information and based at least in part on the programming quality indicator, generate an individualized programming workflow to guide the user to test and program a therapy setting to the electrostimulator (Para. 0122, “The predictions may be further tailored by tracking historical usage of actual parameters versus clinician parameter settings, in situations where the patient may have control over at least a portion of the parameters. This may be further used to determine longevity versus effectiveness of therapy, if it is assumed that the parameter settings by the patient correspond to a more effective therapy, as the patient may alter the parameters to accommodate his/her pain level, for example”); wherein the electrostimulator is configured to provide neuromodulation therapy in accordance with the user programmed therapy setting (Para. 0124, “A user may use a programmer, such as, for example, programmer 20 or 40 of FIGS. 1 and 2, respectively, to program stimulation therapy by selecting parameters (1100) defining the therapy. The programming may be direct, i.e., selecting parameters for electrodes individually, or zone-based, i.e., by defining characteristics or parameters of a zone where therapy is to be applied”).
Regarding Claims 2 and 15, Gillespie teaches the system of Claim 1 and 14, wherein the sequence of programming instructions from the user during the programming session includes one or more of a timing of a programmable parameter being selected, a frequency of a programmable parameter being selected over a specific time period, or an order of selecting multiple programmable parameters, wherein the individualized programming workflow includes selection or deselection of a programmable parameter, or an order of selecting multiple programmable parameters (Para. 0049, “In some examples, implantable stimulator 34 delivers stimulation according to a group of programs at a given time. Each program of such a program group may include respective values for each of a plurality of therapy parameters, such as respective values for each of current or voltage amplitude, pulse width, pulse shape, pulse rate and electrode configuration (e.g., electrode combination and polarity). Implantable stimulator 34 may interleave pulses or other signals according to the different programs of a program group, e.g., cycle through the programs, to simultaneously treat different symptoms or different body regions, or provide a combined therapeutic effect”).
Regarding Claim 3, Gillespie teaches the system of Claim 1, wherein the controller circuit is configured to receive image or video data from an imaging system during the programming session, and to extract information about the sequence of programming instruction from the received image or video data (Para. 0063, “The information stored in the memory 52 may be an image captured and downloaded into the implantable stimulator 34 by a programmer, such as clinician programmer 20 by wireless telemetry. As an example, the image may be obtained during an in-clinic programming session, and may show, for example, lead configuration and placement within a therapy region targeted by one or more leads implanted in the therapy region. Information stored in memory 52 may be retrieved by the programmer to effectively deliver therapy in subsequent sessions”).
Regarding Claim 4, Gillespie teaches system of Claim 1, wherein the user commands and contextual information collected during the programming session further includes time elapsed during an entirety or a portion of the programming session, including time spent when the programmer device is in active communication with the electrostimulator during the programming session (Para. 0093, “Other automatic inputs 700-3 may include performance data, such as the duration of a programming session, the number of time a parameter set was tested and the related patient scores/feedback, etc”).
Regarding Claim 7, Gillespie teaches the system of Claim 1, wherein the user commands and contextual information collected during the programming session further includes patient responses indicative of a therapeutic effect or a side effect of the neuromodulation therapy (Para. 0066, “The remote control device may also provide a mechanism for the patient to provide feedback on the operation of the implantable neuromodulation system. Feedback may be metrics reflecting perceived pain, effectiveness of therapies, or other aspects of patient comfort or condition”).
Regarding Claim 8, Gillespie teaches the system of Claim 1, wherein the controller circuit is configured to determine the programming quality indicator based on a comparison of the sequence of programming instructions to a reference sequence of programming instructions (Para. 0105, “FIG. 16 illustrates, by way of example, an embodiment of a gradient descent method 1600. At block 1602, an initial value of the parameter(s) P is taken. The outcome of the parameter(s) P is evaluated (block 1604). This establishes a starting point for the rest of the evaluations. At block 1606, a descent direct (+ or −) is determined based on the results from adjacent values of P. For example, a value higher than the initial value of P is evaluated and a value lower than the initial value of P is evaluated. Based on which value shows a better result, the descent method 1600 is set to an increasing direction or a decreasing direction. At block 1608, a step size ΔP is selected. The ΔP may be a value based on the initial value of P. For example, if the initial value of P is 200, the ΔP step size may be 50% of the current value of such that the ΔP=100”).
Regarding Claims 9 and 18, Gillespie teaches the inventions of Claims 1 and 14 above, wherein the programming quality indicator includes a programming quality score computed using a weighted combination of various sources of the user commands and contextual information collected during the programming session (Para. 0091, “The search objective may tune the search method 702 to work toward a program that achieves a desired outcome. One or more objectives may be selected. When more than one objective is selective, the combination of objectives may be weighted or ranked”).
Regarding Claim 10, Gillespie teaches the system of Claim 1, wherein the controller circuit is configured to determine the programming quality indicator by applying a trained machine learning model to the user commands and contextual information collected during the programming session (Para. 0110, “It is understood that other methods may be used to determine or classify sensitive/insensitive parameter sets, such as machine learning, neural networks, or guided selection. With guided selection, a user may be presented with various stimulation parameter sets and may drop the insensitive parameters, focusing on the sensitive parameter adjustment. Users may have the option to include insensitive parameters during later stimulation testing. Using sensitivity analysis, a system may automatically choose dimensions or recommend default stimulation parameters”).
Regarding Claims 11 and 19, Gillespie teaches the inventions of Claims 1 and 14, wherein the controller circuit is configured to present on the user interface the individualized programming workflow, including to prompt the user to select or deselect one or more programmable parameters, or to select multiple programmable parameters in a specific order (Para. 0097, “The number of user interface elements in FIG. 8A is five, but it is understood that other numbers of user interface elements may be used, such as, but not limited to ten, twenty, or fifty. In the first instance 802, the UI elements 800 include P1 and P2, which correspond to the first and second programming sets that the patient experienced. The patient is provided user interface element 804, which represents the third programming set P3, to insert among the ordered UI elements 800. The patient may move the UI element 804 to place it in order of perceived performance (e.g., preference)”).
Regarding Claim 12, Gillespie teaches the system of Claim 11, wherein the programmable parameters include at least one of a signal analysis parameter (Para. 0109), or a neuromodulation therapy parameter (Para. 0125).
Regarding Claims 13 and 20, Gillespie teaches the inventions of Claims 1 and 14, wherein the programmer device includes a communication circuit to communicate with a cloud computing system, and to use one or more cloud services provided by the cloud computing system to perform one or more operations including collecting the user commands and contextual information during the programming session, determining the programming quality indicator, or generating the individualized programming workflow (Para. 0087, “The algorithm may reside on the CP, the IPG, the ETS, the RC or other external device used by the patient, or in the cloud or remote servers connected to patient external via Wi-Fi, Bluetooth, cellular data, or other wired/wireless scheme. There may be a GUI on the CP, remote control, or other external device, that enables selection of algorithm as well as manual input. Training of the algorithm may take place in the clinic or in daily life, and may be set to be execute continually or only at certain times. Optimization data may be stored in the cloud so that optimized patterns and history can be transferred when the patient moves from trial to permanent implant and also if the IPG is replaced”).
Regarding Claim 16, Gillespie teaches the system of Claim 14, wherein the user commands and contextual information collected during the programming session includes at least one of: time elapsed during an entirety or a portion of the programming session, including time spent when the programmer device is in active communication with the electrostimulator during the programming session (Para. 0093, “Other automatic inputs 700-3 may include performance data, such as the duration of a programming session, the number of time a parameter set was tested and the related patient scores/feedback, etc.”).
Claim Rejections - 35 USC § 103
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.
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.
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20170080234 awarded to Gillespie et al, hereinafter Gillespie as applied to the claims above, and further in view of U.S. Patent Publication 20240139527 awarded to Taff et al, hereinafter Taff.
Regarding Claim 5, Gillespie teaches the system of Claim 1, wherein Gillespie teaches the need to minimize power consumption of the device (Para. 0125). Gillespie does not teach wherein the user commands and contextual information collected during the programming session further includes wherein the user commands and contextual information collected during the programming session further includes an estimate of power consumption during an entirety or a specific portion of the programming session, including an estimate of power consumption when the programmer device is in active communication with the electrostimulator during the programming session.
However, in the art of stimulation devices (abstract), Taff teaches wherein the user commands and contextual information collected during the programming session further includes wherein the user commands and contextual information collected during the programming session further includes an estimate of power consumption during an entirety or a specific portion of the programming session, including an estimate of power consumption when the programmer device is in active communication with the electrostimulator during the programming session to maintain battery health of the apparatus (Para. 0013, “A remote monitoring device that utilizes RF telemetry for communication thus has the potential to prematurely deplete the battery of an implantable device. Described below are power management schemes that may be implemented in the patient management system for optimizing, limiting, and/or monitoring RF telemetry usage by the implantable device to avoid premature battery depletion and/or raise an alert if excessive battery depletion is beginning to occur”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gillespie by Taff, i.e. by using the power monitoring system of Taff in the system of Gillespie, for the predictable purpose of improving the battery management of Gillespie in the same manner as in Taff.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20170080234 awarded to Gillespie et al, hereinafter Gillespie as applied to the claims above, and further in view of U.S. Patent Publication 20240139527 awarded to Taff et al, hereinafter Taff, in further view of U.S. Patent Publication 20070150028 awarded to Parkinson et al, hereinafter Parkinson.
Regarding Claim 6, Gillespie modified by Taff makes obvious the system of Claim 5. Gillespie further teaches the need to minimize power consumption of the device (Para. 0125). Gillespie does not teach wherein the individualized programming workflow includes an ordered selection of multiple programmable parameters based on their respective dependencies on an active communication during the programming session, such that a first group of programmable parameters that do not require active communication during the programming session are selected prior to a second group of programmable parameters that require active communication during the programming session.
However, in the art of stimulation therapy (abstract), Parkinson teaches wherein the individualized programming workflow includes an ordered selection of multiple programmable parameters based on their respective dependencies on an active communication during the programming session, such that a first group of programmable parameters that do not require active communication during the programming session are selected prior to a second group of programmable parameters that require active communication during the programming session (Para. 0029, “In the following, the processing state is also called the ‘busy state’. When the IMD's communication support is not in the ‘busy state’ but engaged in a communication link with the external device it simply resides in an ‘active state’ (where the transceiver is ON and the IMD is ready for further interaction with the external device). In the active state, the processor is not ‘busy’ and is capable of receiving requests from an external device that may be subsequently handled. Conditions where the processor may change from the ‘active state’ (i.e., an initial standby state) to the ‘processing state’ may be predefined and, for example, stored in a data memory of the IMD or the handling of any specific request from the external device and the emergent, resulting durations needed for such handling may simply instate such transitions. After finishing the respective task that has held the IMD in a ‘busy state” the processor switches back to the ‘active state’”) for the purpose of improving battery longevity and allowing smaller batteries/smaller device sizes (Para. 0005-0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gillespie by Parkinson, i.e. by using the ordering system of Parkinson above in the system of Gillespie, for the predictable purpose of improving the battery management of Gillespie in the same manner as in Parkinson.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20170080234 awarded to Gillespie et al, hereinafter Gillespie as applied to claims above, and further in view of U.S. Patent Publication 20070150028 awarded to Parkinson et al, hereinafter Parkinson.
Regarding Claim 17, Gillespie teaches the method of Claim 16, wherein Gillespie teaches the need to minimize power consumption of the device (Para. 0125). Gillespie does not teach wherein the individualized programming workflow includes an ordered selection of multiple programmable parameters based on their respective dependencies on an active communication during the programming session, such that a first group of programmable parameters that do not require active communication during the programming session are selected prior to a second group of programmable parameters that require active communication during the programming session.
However, in the art of stimulation therapy (abstract), Parkinson teaches wherein the individualized programming workflow includes an ordered selection of multiple programmable parameters based on their respective dependencies on an active communication during the programming session, such that a first group of programmable parameters that do not require active communication during the programming session are selected prior to a second group of programmable parameters that require active communication during the programming session (Para. 0029, “In the following, the processing state is also called the ‘busy state’. When the IMD's communication support is not in the ‘busy state’ but engaged in a communication link with the external device it simply resides in an ‘active state’ (where the transceiver is ON and the IMD is ready for further interaction with the external device). In the active state, the processor is not ‘busy’ and is capable of receiving requests from an external device that may be subsequently handled. Conditions where the processor may change from the ‘active state’ (i.e., an initial standby state) to the ‘processing state’ may be predefined and, for example, stored in a data memory of the IMD or the handling of any specific request from the external device and the emergent, resulting durations needed for such handling may simply instate such transitions. After finishing the respective task that has held the IMD in a ‘busy state” the processor switches back to the ‘active state’”) for the purpose of improving battery longevity and allowing smaller batteries/smaller device sizes (Para. 0005-0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gillespie by Parkinson, i.e. by using the ordering system of Parkinson above in the system of Gillespie, for the predictable purpose of improving the battery management of Gillespie in the same manner as in Parkinson.
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
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792