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
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.
Claim(s) 1-4, 6-14, and 16-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2019/0009094 Zhang et al., hereinafter “Zhang”.
Regarding claim 1, Zhang discloses a data processing system (Abstract and Figure 13 and 14) for planning neurostimulation of a patient (Abstract), comprising:
at least one memory device (Para 82) configured to store user input data corresponding to an autonomic condition of a patient (Para 80, 103, and 135; the memory hold the program instructions, which include pain regions inputted by the patient) and autonomic mapping data corresponding to a physiological state of one or more anatomical systems or organs of the patient affected by the autonomic condition (Para 6, 103, and 135; Pain syndrome is directly affected by the autonomic nervous system; Applicants specification discloses that the maps could be dermatomal maps which are disclosed by Para 134-135); and
at least one processor (Para 82 and Figure 13, element 1316) configured to:
identify a configuration of a neurostimulation device and one or more neurostimulation leads and electrodes to the neurostimulation device (Para 67, 69, and 77; determine number of leads and electrodes needed to be used);
determine a simulated placement of the one or more neurostimulation leads and electrodes onto one or more neural targets of the patient (Para 58; “receive recommendations regarding neural targets, and/or may select one or more neural targets and receive recommendation for a waveform”, Para 19, 21, 58, and 64), based on the user input data corresponding to the autonomic condition and the autonomic mapping data corresponding to the physiological state (Para 58 and 128), wherein the user input data includes data from a symptom questionnaire, and wherein the symptom questionnaire provides a measurement of severity and effects of the autonomic condition from multiple anatomical systems or organs (Para 135 shows a graphical interface that allows the user to highlight areas of pain when prompted, see Also Para 134 and 138; Examiner believes these disclosures are enough to read on this limitation, a dermatome map asking the user to highlight areas of pain is a form of questionnaire that allows the user to show a symptom (i.e. pain) they are experiencing; examiner also believes that any indication of pain is a measurement of severity. Applicant has not defined what a measurement of severity means, under BRI a user experiencing pain vs. no pain are two levels of severity. Examiner suggests amending to define what a measurement of severity entails. Lastly, effects of the autonomic condition from multiple anatomical systems or organs are also shown in Para 135 and Figure 20. When a user identifies that they are feeling pain in a region, the system identifies anatomical systems or neural targets that are associated with that area of pain and recommends neurostimulation to that area); and
output a graphical representation to depict the simulated placement of the one or more neurostimulation leads and electrodes in the patient, based on a simulated neurostimulation treatment for the autonomic condition (Para 135 and Figure 20).
Regarding claim 2, Zhang discloses the one or more neural targets of the patient include one or more spinal neural targets (Para 68), and wherein the neurostimulation includes spinal cord stimulation (SCS) to be provided via the one or more neurostimulation leads and electrodes to the one or more spinal neural targets (Para 77 and 92).
Regarding claim 3, Zhang discloses the data processing system (Abstract and Figure 13 and 14) is further configured to:
determine one or more stimulation settings to provide the simulated neurostimulation treatment via the one or more neurostimulation leads and electrodes, based on the autonomic condition and the simulated placement of the one or more neurostimulation leads and electrodes (Para 58, 64, and 112; stimulation parameters are set based on user input and are customized based on user’s condition).
Regarding claim 4, Zhang discloses the data processing system is further configured to:
output information to depict the one or more stimulation settings to provide the simulated neurostimulation treatment, wherein the information includes:
one or more spatial targets, one or more frequencies, and one or more pulse-widths used for the neurostimulation (Para 135 and Figure 20 show a display of a user interface with output information that discusses the spatial target, a recommended frequency and PW, these can be seen in the neural targets image).
Regarding claim 6, Zhang discloses the autonomic mapping data includes a mapping of effects of the autonomic condition at multiple areas corresponding to the one or more neural targets (Para 103, 111, 131).
Regarding claim 7, Zhang discloses the graphical representation is further configured to display anatomical maps (Para 134 and Figure 20; Dermatome Map), and wherein the anatomical maps include one or more visceral maps or dermatomal maps (Para 134 and Figure 20; Dermatome Map).
Regarding claim 8, Zhang discloses the configuration of the one or more neurostimulation leads and electrodes to a neurostimulation device is based on: type of implantable pulse generator, type of lead, number of leads, and number of electrodes on respective leads (Para 77 and 82); and wherein the simulated placement of the one or more neurostimulation leads and electrodes onto the one or more neural targets of the patient is based on a patient-specific anatomy determined from medical imaging or recorded measurements of the patient (Para 58).
Regarding claim 9, Zhang discloses the simulated placement is determined by a planning model that uses a lookup table (Para 58 and 110), and wherein the lookup table provides a correspondence between the anatomical systems or organs of the patient affected by the autonomic condition and spinal column origins within a stimulation field created by the one or more neurostimulation leads and electrodes (Para 58).
Regarding claim 10, Zhang discloses programming circuitry (Figure 14, element 1419) configured to generate programming for an electrostimulator (Para 112), the programming corresponding to the neurostimulation to the one or more neural targets of the patient via the one or more neurostimulation leads and electrodes (Para 112);
wherein the programming includes one or more stimulation parameters including:
an electrode configuration (Para 6);
one or more stimulation pulse parameters including a pulse amplitude (Para 83), a pulse width (Para 83), or a stimulation frequency (Para 83);
a stimulation pulse waveform (Para 6);
an ON-OFF cycling scheme comprising an ON period for delivering stimulation pulses and a subsequent stimulation-free OFF period (Para 63); or
a charge per second (CPS) or a charge per hour (CPH) delivered to a respective neural target.
Regarding claim 11, Zhang discloses a method (Abstract and Figure 13 and 14) for planning neurostimulation of a patient (Abstract), comprising:
receiving user input data corresponding to an autonomic condition of a patient (Para 80, 103, and 135; pain regions inputted by the patient) and autonomic mapping data corresponding to a physiological state of one or more anatomical systems or organs of the patient affected by the autonomic condition (Para 6, 103, and 135; Pain syndrome is directly affected by the autonomic nervous system; Applicants specification discloses that the maps could be dermatomal maps which are disclosed by Para 134-135);
identifying a configuration of a neurostimulation device and one or more neurostimulation leads and electrodes to the neurostimulation device (Para 67, 69, and 77; determine number of leads and electrodes needed to be used);
determining a simulated placement of the one or more neurostimulation leads and electrodes onto one or more neural targets of the patient (Para 58; “receive recommendations regarding neural targets, and/or may select one or more neural targets and receive recommendation for a waveform”, Para 19, 21, 58, and 64), based on the user input data corresponding to the autonomic condition and the autonomic mapping data corresponding to the physiological state (Para 58 and 128), wherein the user input data includes data from a symptom questionnaire, and wherein the symptom questionnaire provides a measurement of severity and effects of the autonomic condition from multiple anatomical systems or organs (Para 135 shows a graphical interface that allows the user to highlight areas of pain when prompted, see Also Para 134 and 138; Examiner believes these disclosures are enough to read on this limitation, a dermatome map asking the user to highlight areas of pain is a form of questionnaire that allows the user to show a symptom (i.e. pain) they are experiencing; examiner also believes that any indication of pain is a measurement of severity. Applicant has not defined what a measurement of severity means, under BRI a user experiencing pain vs. no pain are two levels of severity. Examiner suggests amending to define what a measurement of severity entails. Lastly, effects of the autonomic condition from multiple anatomical systems or organs are also shown in Para 135 and Figure 20. When a user identifies that they are feeling pain in a region, the system identifies anatomical systems or neural targets that are associated with that area of pain and recommends neurostimulation to that area); and
outputting a graphical representation to depict the simulated placement of the one or more neurostimulation leads and electrodes in the patient, based on a simulated neurostimulation treatment for the autonomic condition (Para 135 and Figure 20).
Regarding claim 12, Zhang discloses the one or more neural targets of the patient include one or more spinal neural targets (Para 68), and wherein the neurostimulation includes spinal cord stimulation (SCS) to be provided via the one or more neurostimulation leads and electrodes to the one or more spinal neural targets (Para 77 and 92).
Regarding claim 13, Zhang discloses determining one or more stimulation settings to provide the simulated neurostimulation treatment via the one or more neurostimulation leads and electrodes, based on the autonomic condition and the simulated placement of the one or more neurostimulation leads and electrodes (Para 58, 64, and 112; stimulation parameters are set based on user input and are customized based on user’s condition).
Regarding claim 14, Zhang discloses outputting information to depict the one or more stimulation settings to provide the simulated neurostimulation treatment, wherein the information includes: one or more spatial targets, one or more frequencies, and one or more pulse-widths used for the neurostimulation (Para 135 and Figure 20 show a display of a user interface with output information that discuss the spatial target, a recommended frequency and PW, these can be seen in the neural targets image).
Regarding claim 16, Zhang discloses the autonomic mapping data includes a mapping of effects of the autonomic condition at multiple areas corresponding to the one or more neural targets (Para 103, 111, 131).
Regarding claim 17, Zhang discloses the graphical representation is further configured to display anatomical maps (Para 134 and Figure 20; Dermatome Map), and wherein the anatomical maps include one or more visceral maps or dermatomal maps (Para 134 and Figure 20; Dermatome Map).
Regarding claim 18, Zhang discloses the configuration of the one or more neurostimulation leads and electrodes to a neurostimulation device is based on: type of implantable pulse generator, type of lead, number of leads, and number of electrodes on respective leads (Para 77 and 82); and
wherein the simulated placement of the one or more neurostimulation leads and electrodes onto the one or more neural targets of the patient is based on a patient-specific anatomy determined from medical imaging or recorded measurements of the patient (Para 58).
Regarding claim 19, Zhang discloses the simulated placement is determined by a planning model that uses a lookup table (Para 58 and 110), and wherein the lookup table provides a correspondence between the anatomical systems or organs of the patient affected by the autonomic condition and spinal column origins within a stimulation field created by the one or more neurostimulation leads and electrodes (Para 58).
Regarding claim 20, Zhang discloses generating programming for an electrostimulator (Para 112), the programming corresponding to the neurostimulation to the one or more neural targets of the patient via the one or more neurostimulation leads and electrodes (Para 112);
wherein the programming includes one or more stimulation parameters including:
an electrode configuration (Para 6);
one or more stimulation pulse parameters including a pulse amplitude (Para 83), a pulse width (Para 83), or a stimulation frequency (Para 83);
a stimulation pulse waveform (Para 6);
an ON-OFF cycling scheme comprising an ON period for delivering stimulation pulses and a subsequent stimulation-free OFF period (Para 63);
or a charge per second (CPS) or a charge per hour (CPH) delivered to a respective neural target.
Response to Arguments
Applicant’s arguments have been fully considered but are moot because of the new ground of rejection.
Regarding applicant’s arguments, examiner respectfully disagrees.
First, applicant argues that reference Zhang does not disclose autonomic conditions. However, Para 135 recites the treatment of complex regional pain syndrome (CRPS) which is an autonomic condition.
Second applicant argues that Zhang does not recite autonomic mapping data. Applicant recites in their specification that the mapping can include a dermatomal map (Para 12 of applicant’s specification), Zhang discloses exactly that in Para 135 “Neural elements believed to be associated with the pain state mat be shown and may be selectable in some examples. In the illustrated examples, dermatome maps are shown to allow the user or the patient to identify the painful region by highlighting”.
Applicant also argues the newly amended limitation from claims 5 and 15 “wherein the user input data includes data from a symptom questionnaire, and wherein the symptom questionnaire provides a measurement of severity and effects of the autonomic condition from multiple anatomical systems or organs”. Examiner respectfully disagrees with that argument. Para 135 shows a graphical interface that allows the user to highlight areas of pain when prompted, see Also Para 134 and 138; Examiner believes these disclosures are enough to read on this limitation, a dermatome map asking the user to highlight areas of pain is a form of questionnaire that allows the user to show a symptom (i.e. pain) they are experiencing; examiner also believes that any indication of pain is a measurement of severity. Applicant has not defined what a measurement of severity means, under BRI a user experiencing pain vs. no pain are two levels of severity. Examiner suggests amending to define what a measurement of severity entails. Lastly, effects of the autonomic condition from multiple anatomical systems or organs are also shown in Para 135 and Figure 20. When a user identifies that they are feeling pain in a region, the system identifies anatomical systems or neural targets that are associated with that area of pain and recommends neurostimulation to that area.
Applicants’ argument of claims 6 and 16 is addressed above.
Applicants’ argument regarding claims 7 and 17 is noted, but examiner respectfully disagrees. Para 135 clearly states that a dermatome map is displayed to the user so they can select areas of pain. Para 135 states “In the illustrated examples, dermatome maps are shown to allow the user or the patient to identify the painful region by highlighting.”
Lastly, applicants’ argument regarding claims 9 and 19 is noted, but examiner respectfully disagrees. Para 135 discloses when a user identifies that they are feeling pain in a region, the system identifies anatomical systems or neural targets that are associated with that area of pain and recommends neurostimulation to that area “In the illustrated examples, dermatome maps are shown to allow the user or the patient to identify the painful region by highlighting. Neural target information shown to the user include recommended lead placement, recommended stimulation waveform produced based on back-calculation from the selected neural target (pain dermatomes highlighted by the user or the patient)”, see also Figure 20 that shows the neural targets. These are neural targets affected by CPRS.
Examiner suggests an amendment to the claims to overcome reference Zhang.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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