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 on 10/03/2025 have been fully considered but they are not persuasive. Applicant argues that Miesel fails to disclose the newly amended limitation of “sensing circuitry configured to sense bioelectrical signals via a second set of electrodes of the plurality of electrodes implanted proximal to the spinal cord during the therapy phase for storage as part of the sensed signals”. Examiner respectfully disagrees as Miesel discloses circuitry that conditions signals generated by sensors 40 such that they may be analyzed by the processor [0062]. Miesel also teaches that leads 16 may each include eight electrodes 40 [0059], and further discloses sensors/electrodes 40 may be coupled to IMD 14 via therapy leads 16A-16D [0063], which may be implanted proximate to the spinal cord of the patient (Figure 1A; [0028]). Therefore the sensing circuitry [0062] is configured to sense bioelectrical signals via a second set of electrodes of the plurality of electrodes [0059] implanted proximal to the spinal cord [0028] as shown in Figure 2A.
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) 1-2, 7-11, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miesel (US Publication 2012/0150258).
Regarding claim 1, Miesel discloses an implantable medical device, the device comprising:
a memory configured to store sensed signals (Figure 2A: memory 48; [0084] processor 46 may periodically store samples of the signals generated by sensors 40 in memory 48; [0092] Memory 48 also stores postures 62 or postural transitions identified by processor 46);
one or more sensors configured to determine posture and activity information of the patient during a therapy phase for storage as part of the sensed signals ([0062] Each of sensors 40 generates a signal that varies as a function of patient activity and/or posture);
stimulation circuitry configured to deliver electrical stimulation to a patient via a first set of electrodes of a plurality of electrodes implanted proximal to a spinal cord of the patient ([0028] Leads 16A and 16B may, as shown in FIG. 1A, be implanted proximate to the spinal cord 18; [0059] IMD 14A may deliver neurostimulation therapy via electrodes 42A-D of lead 16A and electrodes 42E-H of lead 16B; [0060] Therapy delivery module 44 may deliver electrical pulses to a patient 12 via at least some of electrodes 42 under the control of a processor 46);
sensing circuitry configured to sense bioelectrical signals via a second set of electrodes of the plurality of electrodes implanted proximal to the spinal cord during the therapy phase for storage as part of the sensed signals ([0062] An IMD 14 may include circuitry (not shown) that conditions the signals generated by sensors 40 such that they may be analyzed by processor 46; [0059] leads 16 may each include eight electrodes 40; [0028] Leads 16A and 16B may, as shown in FIG. 1A, be implanted proximate to the spinal cord 18); and
processing circuitry operably coupled to the memory (Figure 2A: processor 46, memory 48), the processing circuitry configured to:
during the therapy phase, receive the sensed signals ([0062] the signals generated by sensors 40 such that they may be analyzed by processor 46), wherein the sensed signals comprise:
bioelectrical signals via one or more electrodes of the plurality of electrodes and
the posture and activity information determined by the one or more sensors ([0062] Each of sensors 40 generates a signal that varies as a function of patient activity and/or posture; Examiner notes that any signal sensed by electrodes 40 would be a bioelectrical signal; [0068] Processor 46 may identify postures and record activity levels continuously or periodically, e.g., one sample of the signals output by sensors 40);
determine, during the therapy phase, respiration activity of the patient based on the sensed signals ([0071] processor 46 may monitor any one or more physiological parameters that discernibly change when the patient 12 falls asleep, such as respiration rate, respiratory volume; [0082] processor 46 may monitor one or more signals that indicate a physiological parameter of a patient 12, which in turn varies as a function of patient activity. For example, processor 46 may monitor a signal that indicates the respiration rate, respiratory volume; Examiner notes that the respiration rate/ respiratory volume vary as a function of patient activity);
determine, during the therapy phase, a degree of distress of the patient based on the sensed signals and the determined respiration activity ([0131] an IMD 14 then compares a value of the one or more metrics defined by the perturbed therapy parameter set to a corresponding value of the metric defined by the baseline therapy parameter set during the initial baseline identification phase (142); [0136] Systems according to the invention may monitor activity and activity metrics to evaluate the extent to which the patient is experiencing pain); and
responsive to determining the degree of distress, increase or decrease the electrical stimulation ([0131] If the metric values do improve with the perturbation, an IMD 14 perturbs the therapy parameter value again (146) in the same direction that defined the previous improvement in the metric values; [0137] evaluate the extent to which a therapy or therapy parameter set is alleviating chronic pain by evaluating the extent to which the therapy or therapy parameter set allows the patient to be more active or engage in particular activities or postures).
Regarding claim 2, Miesel discloses wherein the processing circuitry is further configured to output a command signal based on the degree of distress ([0131] If the metric values do improve with the perturbation, an IMD 14 perturbs the therapy parameter value again (146); Examiner notes the processor would have to output a command signal in order for the subsequent perturbation to occur).
Regarding claim 7, Miesel discloses wherein the processing circuitry is configured to analyze the sensed signals and based on the analyzed signals determine for the patient: a respiration rate, cardiac rhythm, and biological impedance ([0071] processor 46 may monitor any one or more physiological parameters that discernibly change when the patient 12 falls asleep, such as activity level, heart rate, ECG morphological features, respiration rate, respiratory volume, blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity and tone, core temperature, subcutaneous temperature, arterial blood flow, brain electrical activity, eye motion, and galvanic skin response; [0078] sensors 40 may include an electrode pair, including one electrode integrated with the housing of an IMD 14 and one of electrodes 42, that generates a signal as a function of the thoracic impedance of a patient 12).
Regarding claim 8, Miesel discloses wherein the sensed signals comprise signals from sensors external to the device ([0055] systems 10 may include a separate implanted or external monitor that includes or is coupled to such sensors).
Regarding claim 9, Miesel discloses wherein the processing circuitry is configured to: detect a predetermined posture ([0065] processor 46 may be able to periodically determine whether patient is, for example, upright or recumbent, e.g., lying down); and
determine the degree of distress based on detecting the predetermined posture ([0136] chronic pain chronic pain may cause a patient to avoid particular activities, high levels of activity, or activity in general. Systems according to the invention may monitor activity and activity metrics to evaluate the extent to which the patient is experiencing pain).
Regarding claim 10, Miesel discloses a system comprising:
an implantable lead comprising a plurality of electrodes, the lead configured to be implanted proximal to a spinal cord of a patient ([0028] Leads 16A and 16B may, as shown in FIG. 1A, be implanted proximate to the spinal cord 18 of patient 12A; [0059] electrodes 42A-D of lead 16A and electrodes 42E-H of lead 16B); and
an implantable medical device ([0027] an implantable medical device (IMD) 14A), the device comprising:
a memory configured to store sensed signals (Figure 2A: memory 48; [0084] processor 46 may periodically store samples of the signals generated by sensors 40 in memory 48; [0092] Memory 48 also stores postures 62 or postural transitions identified by processor 46);
one or more sensors configured to determine posture and activity information of the patient during a therapy phase for storage as part of the sensed signals ([0062] Each of sensors 40 generates a signal that varies as a function of patient activity and/or posture);
stimulation circuitry configured to deliver electrical stimulation to the patient via a first set of electrodes of the plurality of electrodes ([0060] Therapy delivery module 44 may deliver electrical pulses to a patient 12 via at least some of electrodes 42 under the control of a processor 46);
sensing circuitry configured to sense bioelectrical signals via a second set of electrodes of the plurality of electrodes implanted proximal to the spinal cord during the therapy phase for storage as part of the sensed signals ([0062] An IMD 14 may include circuitry (not shown) that conditions the signals generated by sensors 40 such that they may be analyzed by processor 46; [0059] leads 16 may each include eight electrodes 40; [0028] Leads 16A and 16B may, as shown in FIG. 1A, be implanted proximate to the spinal cord 18); and
processing circuitry operably coupled to the memory (Figure 2A: processor 46, memory 48), the processing circuitry configured to:
during the therapy phase, receive the sensed signals ([0062] the signals generated by sensors 40 such that they may be analyzed by processor 46), wherein the sensed signals comprise:
the bioelectrical signals sensed via the second set of electrodes of the plurality of electrodes and the posture and activity information determined by the one or more sensors ([0062] Each of sensors 40 generates a signal that varies as a function of patient activity and/or posture; Examiner notes that any signal sensed by electrodes 40 would be a bioelectrical signal; [0068] Processor 46 may identify postures and record activity levels continuously or periodically, e.g., one sample of the signals output by sensors 40);
determine, during the therapy phase, respiration activity of the patient based on the sensed signals ([0071] processor 46 may monitor any one or more physiological parameters that discernibly change when the patient 12 falls asleep, such as respiration rate, respiratory volume; [0082] processor 46 may monitor one or more signals that indicate a physiological parameter of a patient 12, which in turn varies as a function of patient activity. For example, processor 46 may monitor a signal that indicates the respiration rate, respiratory volume; Examiner notes that the respiration rate/ respiratory volume vary as a function of patient activity);
determine, during the therapy phase, a degree of distress of the patient based on the sensed signals and the determined respiration activity ([0131] an IMD 14 then compares a value of the one or more metrics defined by the perturbed therapy parameter set to a corresponding value of the metric defined by the baseline therapy parameter set during the initial baseline identification phase (142); [0136] Systems according to the invention may monitor activity and activity metrics to evaluate the extent to which the patient is experiencing pain); and
responsive to determining the degree of distress, increase or decrease the electrical stimulation ([0131] If the metric values do improve with the perturbation, an IMD 14 perturbs the therapy parameter value again (146) in the same direction that defined the previous improvement in the metric values; [0137] evaluate the extent to which a therapy or therapy parameter set is alleviating chronic pain by evaluating the extent to which the therapy or therapy parameter set allows the patient to be more active or engage in particular activities or postures).
Regarding claim 11, Miesel discloses wherein the processing circuitry is further configured to output a command signal based on the degree of distress ([0131] If the metric values do improve with the perturbation, an IMD 14 perturbs the therapy parameter value again (146); Examiner notes the processor would have to output a command signal in order for the subsequent perturbation to occur).
Regarding claim 16, Miesel discloses wherein the processing circuitry is configured to analyze the bioelectrical signals sensed via the one or more electrodes and based on the analyzed signals determine for the patient: a respiration rate, cardiac rhythm, and biological impedance ([0071] processor 46 may monitor any one or more physiological parameters that discernibly change when the patient 12 falls asleep, such as activity level, heart rate, ECG morphological features, respiration rate, respiratory volume, blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity and tone, core temperature, subcutaneous temperature, arterial blood flow, brain electrical activity, eye motion, and galvanic skin response; [0078] sensors 40 may include an electrode pair, including one electrode integrated with the housing of an IMD 14 and one of electrodes 42, that generates a signal as a function of the thoracic impedance of a patient 12).
Regarding claim 17, Miesel discloses wherein the sensed signals comprise signals from sensors external to the device ([0055] systems 10 may include a separate implanted or external monitor that includes or is coupled to such sensors).
Regarding claim 18, Miesel discloses wherein the processing circuitry is configured to: detect a predetermined posture ([0065] processor 46 may be able to periodically determine whether patient is, for example, upright or recumbent, e.g., lying down); and
determine the degree of distress based on detecting the predetermined posture ([0136] chronic pain chronic pain may cause a patient to avoid particular activities, high levels of activity, or activity in general. Systems according to the invention may monitor activity and activity metrics to evaluate the extent to which the patient is experiencing pain).
Regarding claim 19, Miesel discloses a method for operating an implantable medical device, the method comprising:
receiving, during a therapy phase and by processing circuitry located within a housing of the medical device, sensed signals ([0062] the signals generated by sensors 40 such that they may be analyzed by processor 46), wherein the sensed signals comprise:
bioelectrical signals received by sensing circuitry via one or more electrodes of a plurality of electrodes on an implantable lead coupled to the implantable medical device ([0062] An IMD 14 may include circuitry (not shown) that conditions the signals generated by sensors 40 such that they may be analyzed by processor 46; [0059] leads 16 may each include eight electrodes 40), the lead configured to be implanted such that the electrodes are proximal to a spinal cord of a patient ([0028] Leads 16A and 16B may, as shown in FIG. 1A, be implanted proximate to the spinal cord 18); and
signals indicative of patient posture and patient activity information from one or more sensors located within the housing of the implantable medical device ([0062] Each of sensors 40 generates a signal that varies as a function of patient activity and/or posture; [0068] Processor 46 may identify postures and record activity levels continuously or periodically, e.g., one sample of the signals output by sensors 40);
storing the sensed signals at a memory device operatively coupled to the processing circuitry (Figure 2A: memory 48; [0084] processor 46 may periodically store samples of the signals generated by sensors 40 in memory 48; [0092] Memory 48 also stores postures 62 or postural transitions identified by processor 46);
determining, during the therapy phase, respiration activity of the patient based on the sensed signals ([0071] processor 46 may monitor any one or more physiological parameters that discernibly change when the patient 12 falls asleep, such as respiration rate, respiratory volume; [0082] processor 46 may monitor one or more signals that indicate a physiological parameter of a patient 12, which in turn varies as a function of patient activity. For example, processor 46 may monitor a signal that indicates the respiration rate, respiratory volume; Examiner notes that the respiration rate/ respiratory volume vary as a function of patient activity);
determining, during the therapy phase, a degree of distress of the patient based on the sensed signals and the determined respiration activity ([0131] an IMD 14 then compares a value of the one or more metrics defined by the perturbed therapy parameter set to a corresponding value of the metric defined by the baseline therapy parameter set during the initial baseline identification phase (142); [0136] Systems according to the invention may monitor activity and activity metrics to evaluate the extent to which the patient is experiencing pain); and
responsive to determining the degree of distress, by the processing circuitry, increasing or decreasing the electrical stimulation ([0131] If the metric values do improve with the perturbation, an IMD 14 perturbs the therapy parameter value again (146) in the same direction that defined the previous improvement in the metric values; [0137] evaluate the extent to which a therapy or therapy parameter set is alleviating chronic pain by evaluating the extent to which the therapy or therapy parameter set allows the patient to be more active or engage in particular activities or postures).
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) 3, 12-13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Miesel (US Publication 2012/0150258) in view of Srivastava et al (US Publication 2021/0060343) hereinafter Srivastava.
Regarding claims 3, 12, and 20, Miesel discloses wherein to output the command signal, the processing circuitry is configured to output the command signal to communication circuitry (Figure 2A: processor 46, telemetry 50), but fails to disclose wherein the command signal causes the communication circuitry to send an electronic message comprising a notification of the degree of distress of the patient.
However, Srivastava discloses wherein to output the command signal, the processing circuitry is configured to output the command signal to communication circuitry ([0048] an external system 130 in communication with the implantable system 110 via a communication link 120), and wherein the command signal causes the communication circuitry to send an electronic message comprising a notification of the degree of distress of the patient ([0049] The IND 112 may generate an alert to indicate occurrence of a pain episode, pain exacerbation, or efficacy of pain therapy, and present the alert to a clinician).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Miesel with the command signal causes the communication circuitry to send an electronic message comprising a notification of the degree of distress of the patient as taught by Srivastava. Such a modification would provide the predictable results of allowing the patient or physician to analyze the efficacy of the delivered therapy and make adjustments to the parameters if needed.
Regarding claim 13, the modified Miesel discloses the system of claim 12 as discussed above, but fails to disclose wherein the electronic message is configured to notify a caregiver regarding the degree of distress of the patient. However, Srivastava discloses wherein the electronic message is configured to notify a caregiver regarding the degree of distress of the patient ([0049] The IND 112 may generate an alert to indicate occurrence of a pain episode, pain exacerbation, or efficacy of pain therapy, and present the alert to a clinician). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Miesel with the electronic message being configured to notify a caregiver regarding the degree of distress of the patient as taught by Srivastava. Such a modification would provide the predictable results of allowing the patient or physician to analyze the efficacy of the delivered therapy and make adjustments to the parameters if needed.
Claim(s) 5-6 and 14-15, are rejected under 35 U.S.C. 103 as being unpatentable over Miesel (US Publication 2012/0150258) in view of Hilderbrand et al (US Publication 2005/0177135) hereinafter Hilderbrand.
Regarding claims 5 and 14, Miesel discloses wherein to output the command signal, the processing circuitry is configured to output the command signal to communication circuitry (Figure 2A: processor 46, telemetry 50), but fails to disclose wherein the command signal causes a second medical device separate from the device to change an operation based on the degree of distress.
However, Hilderbrand discloses wherein to output the command signal, the processing circuitry is configured to output the command signal to communication circuitry, and wherein the command signal causes a second medical device separate from the device to change an operation based on the degree of distress ([0083] the operating system of the external drug pump 40 receives and stores dosage commands transmitted from the IHM 60 that establish the frequency of delivery and/or bolus volume of the dosage of the sympatholytic cardiovascular agent delivered through the drug infusion catheter 44).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the systems as taught by Miesel with the command signal causes a second medical device separate from the device to change an operation based on the degree of distress as taught by Hilderbrand. Such a modification would provide the predictable results of triggering delivery of an agent to a central nervous system site to alleviate symptoms [0039].
Regarding claims 6 and 15, the modified Miesel discloses the systems of claims 5 and 14 as discussed above, but fails to disclose wherein the second medical device is a drug pump, and wherein the change of operation comprises a change in drug dosage to the patient. However, Hilderbrand discloses wherein the second medical device is a drug pump ([0074] Referring again to FIG. 1, the external drug pump 40 may also be provided with the capability of communicating with an IHM 60), and wherein the change of operation comprises a change in drug dosage to the patient ([0083] commands transmitted from the IHM 60 that establish the frequency of delivery and/or bolus volume of the dosage of the sympatholytic cardiovascular agent delivered through the drug infusion catheter 44).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the systems as taught by Miesel with wherein the second medical device is a drug pump, and wherein the change of operation comprises a change in drug dosage to the patient as taught by Hilderbrand. Such a modification would provide the predictable results of triggering delivery of an agent to a central nervous system site to alleviate symptoms [0039].
Conclusion
Applicant's 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 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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792