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 Objections
Claims 1 & 11 are objected to because of the following informalities:
The phrase “each having a one or more pulse instructions” should be amended to “each having one or more pulse instructions.”
The phrase “identifying a one or more aggregate instructions” should be amended to “identifying one or more aggregate instructions.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. The limitation (line 27) “two therapy configurations to operate simultaneously, using separate DACs and any of the electrodes” fails to clearly define the required relationship between the therapy configurations and the electrodes. It is unclear whether “any of the electrodes” requires different electrodes, requires all electrodes, or merely permits an arbitrary subset of the plurality of electrodes.
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.
Claim(s) 1-5, 9-14 & 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (US 2018/0071516) in view of Skelton et al. (US 2010/0010580).
Claim 1.
Weiss et al. teaches:
Implantable medical device;
E.G. via the disclosed pulse generation having a housing containing a power source, controller and circuitry, including multiple DAC stages ([0034]-[0040], [0060]-[0062]), [0113]).
Leads and electrodes:
E.G. via the disclosed one or more leads carrying a plurality of electrodes through which the stimulation circuitry delivers stimulus pulse patterns ([0034]-[0036]).
Controller memory:
E.G. via the disclosed steering memory, pulse memory, aggregate memory, and configuration memory [0064].
Pulse-definition circuits:
E.G. via the disclosed multiple PDCs, each including steering logic, pulse logic, and aggregate logic and controlling designated DAC circuitry ([0064] & [0113]).
Steering programs:
E.G. via the disclosed steering instructions sets defining electrode polarity and the fractional allocation of total stimulation current among selected electrodes, implemented by the steering logic ([0064]-[0065] & [0084]).
Pulse programs:
E.G. via the disclosed pulse instructions defining pulse components having pulse types and corresponding characteristics, including amplitude, pulse width, compliance, and delay duration ([0068]-[0081])
Aggregate instructions:
E.G. instructions pairing a selected steering program with a selected pulse program and specifying a repeat count defining the number of times the pulse program is executed with the steering program ([0082]-[0083] and [0085]-[0091]).
Therapy configurations:
E.G. via the disclosed PDC-specific configuration identifying aggregate-program addresses and defining output-current scaling, arbitration mode, arbitration holdoff, enable and timing parameters ([0083], [0085], [0094]-[0099], [0100]-[0106]).
Simultaneous operation using separate DACs:
E.G. via the disclosed multiple PDCs simultaneously executing different therapy programs using separately designated DAC circuitry and selected electrodes, including different or overlapping electrode sets subject to arbitration ([0092]-[0093], [0100]-[0105], [0113]).
Weiss et al. does not expressly teach:
Linking data in the configuration memory that associates two therapy configurations for simultaneous operation.
Skelton et al. teaches:
Selectively linking therapy-related posture states and selecting program groups for which linking is active, such that the linked states share therapy parameter values and changes [0239].
Using the linking and link-active group selections to determine the therapy-program changes, or lack of changes, made by the implantable medical device ([0240]-[0241]).
Selecting one or more therapy program groups and the posture states to which the selected groups apply ([0244]-[0248]).
Employing linking to propagate therapy-programming changes among linked states, thereby improving the efficiency and ease of programming the implantable medical device [0242].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Weiss’s configuration memory to incorporate Skelton’s linking information for associating therapy configurations executed by respective PDCs. Weiss already teaches simultaneously executing different therapy configurations using separate PDCs and corresponding DAC circuitry. Incorporating Skelton’s linking mechanism would have predictably allowed the associated configurations to be selected and controlled together for simultaneous execution, thereby improving the efficiency and ease of programming and coordinating multiple stimulation therapies, as expressly recognized by Skelton, ([0239]-[0242]).
Claim 2.
The combination further teaches:
First configuration identifying a second configuration. Skelton et al. teaches linking therapy-related states and selecting program groups for which linking is active. The stored linking information associates the corresponding therapy programs and parameter values, thereby identifying the linked therapy to be applied (Skelton, [0239]-[0241], [0266]).
Under a broadest reasonable interpretation, stored information associating two therapy configurations identifies each configuration as linked with the other.
Claim 3.
Regarding claim 3, the combination further teaches:
Pulses from first and second DACs:
E.G. Weiss et al. teaches different PDCs simultaneously executing different therapy programs through separately designated DAC circuitry, with each program defining its respective pulse amplitude and electrode allocation (Weiss, [0068]-[0081], [0092]-[0093], [0113]).
Simultaneous pulses through the same electrode:
E.G. via the disclosed simultaneous allocation of current from different PDCs to the same electrode, including sharing currents delivered by multiple PDCs through the case electrodes [0093].
Under the BRI a “a first electrode” is not expressly limited to an electrode located on the lead and encompasses Wiess’s case electrode.
Claim 4.
Different total currents:
E.G. via the taught independently programmable, PDC-specific amplitude-scale values that modify the stimulation-current amplitudes generated by the respective DAC circuitry (Weiss, [0094] & [0106]).
First current larger than second current:
E.G. via the disclosed selecting different amplitude-scale values predictably producing different total currents, including a first total current larger than a second total current. Selecting the relative current magnitudes would have been an obvious optimization based on the requirements of the respective therapies.
Claim 5.
Different pulse trains:
E.G. Weiss teaches different PDCs simultaneously executing different aggregate and pulse programs to generate different stimulation patterns ([0074]-[0083] & [0092]-[0093]).
Different pulse-train parameters:
Skelton teaches programs defining different amplitude, pulse widths, pulse rates, durations, and electrode configurations, with multiple programs being delivered simultaneously as part of a program group ([0070]-[0075] and [0116]).
Claim 9.
Deep-brain stimulation systems:
E.G. Weiss expressly teaches that its implantable stimulation architecture is applicable to cortical and deep-brain stimulation.
Lead adapted for placement in the brain:
E.G. Skelton teaches configuring an implantable stimulation system to provide deep-brain stimulation for treating Parkinson’s disease, tremor, epilepsy, etc. ([0064], [0115]).
Clinician programmer:
E.G. Weiss teaches external clinician-programmer software that communicates instructions and configuration parameters to the implantable device [0093].
E.G. Skelton likewise teaches a clinician programmer that communicates with an implantable device and programs of modifies stimulation therapies and program groups ([0075], [0080], [0101]-[0104]).
Programming arbitration mode and holdoff:
E.G. Weiss teaches configuration memory storing arbitration-mode and holdoff settings and clinician programmer software writing the configuration parameters to the implantable device ([0093]-[0105]).
Claim 10.
Spinal-cord stimulation system:
E.G. Weiss expressly describes its implantable pulse generator and stimulation architecture in an SCS system ([0002]-[0003]).
Lead adapted for placement in the spinal column:
E.G. Skelton teaches an implantable SCS system having electrode-bearing leads positioned adjacent the patient’s spinal cord ([0062]-[0066] and [0081]-[0082]).
Clinician programmer and stored settings:
E.G. Weiss and Skelton teach the communicating clinician programmer and programming of the stored arbitration-mode and holdoff setting for the reasons stated regarding claim 9 (Weiss [0093]-[0105]; Skelton [0075], [0080], [0101]-[0104]).
Claim 11
Regarding claim 11, Weiss teaches the limitations shared with claim 1 for the reasons and citations previously provided. Those findings are incorporated herein, except for claim limitation of claim 1 “linking data,” which claim 11 does not recite.
Weiss further teaches:
Scheduler and execution timing:
E.G. via the disclosed controller that executes stored therapy configurations and aggregate programs according to programmed sequencing, repetition, and timing information ([0082]-[0091], [0094]-[0106]).
Simultaneous execution on separate DACs:
E.G. via the disclosed multiple pulse-definition circuits simultaneously executing respective programs using separately designated DACs ([0092]-[0093], [0113]).
Weiss does not expressly teach the scheduler identifying a first therapy configuration as linked to a second therapy configuration.
Skelton teaches:
Therapy states and program groups that may be linked and selected together, and multiple programs within a group that may be delivered simultaneously ([0070]-[0075], [0116] and [0239]-[0248]).
It would have been obvious to modify Weiss’s scheduler to link two therapy configurations as taught by Skelton and execute the linked configurations simultaneously through Weiss’s separate DAC pathways. This would have predictably improved coordinated therapy programming and execution, consistent with Skelton’s expressly identified programming-efficiency benefit [0242].
Claim 12
Regarding claim 12, the rejection of claim 11 is incorporated herein. The additional limitations substantively correspond to those of claim 3. Accordingly, the findings, citations, and reasoning provided for claim 3 are incorporated herein, and claim 12 is rejected for the same reasons.
Claim 13.
Regarding claim 13, the rejection of claim 11 is incorporated herein. The additional limitations substantively correspond to those of claim 4. Accordingly, the findings, citations, and reasoning provided for claim 3 are incorporated herein, and claim 13 is rejected for the same reasons.
Claim 14.
Regarding claim 14, the rejection of claim 11 is incorporated herein. The additional limitations substantively correspond to those of claim 5. Accordingly, the findings, citations, and reasoning provided for claim 3 are incorporated herein, and claim 14 is rejected for the same reasons.
Claim 18.
Regarding claim 18, the rejection of claim 11 is incorporated herein. The additional limitations, such as the clinician programmer and deep brain stimulation limitations substantively correspond to those of claim 9. Accordingly, the findings, citations, and reasoning provided for claim 9 are incorporated herein, and claim 18 is rejected for the same reasons.
Claim 19.
Regarding claim 19, the rejection of claim 11 is incorporated herein. The additional limitations, such as the clinician programmer and spinal-cord stimulation limitations substantively correspond to those of claim 10. Accordingly, the findings, citations, and reasoning provided for claim 10 are incorporated herein, and claim 19 is rejected for the same reasons.
Claim 20.
Claim 20 recites the method counterpart of the linked-configuration and simultaneous-DAC operations addressed regarding claims 2-3, 11-12. The corresponding factual findings and citations are incorporated herein where applicable.
Weiss teaches:
Scheduled configuration execution:
E.G. via the disclosed selecting and executing stored therapy configurations according to programmed sequencing and timing information (Weiss, [0082]-[0091], [0094]-[0106])
Separate DACs:
E.G. via the disclosed simultaneous execution of respective therapy programs through separately designated pulse-definition circuit and DAC pathways (Weiss, [0092]-[0093], [0113])
Combined pulse:
E.G. via the disclosed simultaneous currents from multiple pulse-definition circuits that may be delivered through the common case electrode and combine at that electrode (Weiss, [0093]).
Weiss does not expressly teach calling the second configuration based on its identification as linked to the first configuration.
Skelton teaches linking therapy states and program groups and simultaneously delivering multiple programs within a selected group ([0070]-[0075], [0116] & [0239]-[0248]).
It would have been obvious to apply Skelton’s linking technique to Weiss’s scheduled therapy configurations so that calling the first configuration also calls the linked second configuration for simultaneous execution through separate DAC pathways. This would have predictably improved coordinated therapy programming and execution (Skelton, [0242]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wagenbach et al. (US 2018/0071514) is cited as pertinent but is not relied upon in the rejection. Wagenbach et al. discloses measurement circuitry responsive to triggers from multiple pulse-definition-circuits that generate different stimulation waveforms at different electrode groups. However, Wagenbach does not more directly teach the claimed linking and coordinated execution of therapy configurations than the applied combination of Weiss and Skelton.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796
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