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 .
Amendment
This action is in response to the Amendment filed on 8/6/2026.
Claims 1 and 3-15 are pending.
Examiner’s note: The Application serial number in the header section of the Remarks and the Claims filed on 8/6/2026 is for a different application. However the arguments and the claims correspond to the current application.
Response to Arguments
Applicant's arguments with respect to claims 1 and 3-15 have been considered but are moot in view of the new grounds of rejection.
Claim Objections
In view of the amendments, the claim objections have been withdrawn.
Claim Rejections - 35 U.S.C. 101
In view of the amendments and the arguments, the rejections under 35 USC 101 have been withdrawn.
Claim Rejections - 35 U.S.C. 102- Ghaffari et al. (U.S. Patent Application Publication No. 2017/0095670 Al) ("Ghaffari").
Independent claim 1 (and similarly independent claims 13 and 16) have been amended to include the limitations: “an electrode system configured to be coupled to a nervous system of a patient; a control unit coupled to the electrode system and configured to control electrical stimulation delivered by the electrode system to the nervous system to provide a neurostimulation therapy to the patient; … wherein the health status comprises a likelihood of a medical condition”.
In view of the amendments and arguments, the rejection has been withdrawn. However, upon further search and consideration, the claims are now rejected as discussed in the current office action below.
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, 3-7, 9-11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnes et al (U.S. Patent Application Publication Number: US 2010/0114195 A1, hereinafter “Burnes”).
Regarding claims 1 and 13-15, Burnes teaches an implantable neurostimulation device (e.g. 16 Fig. 3) a method carried out by the implantable stimulation device, a non transitory computer readable medium storing instructions that when executed by a computer, cause the computer to perform the method and use of a neurostimulation device comprising:
an electrode system (e.g. 46,48 50 Fig.3 [0050]: Lead 18 is also implanted within patient 12 such that electrodes 46, 48, and 50 are positioned proximate to spinal cord 38) configured to be coupled to a nervous system of a patient;
a control unit coupled to the electrode system and configured to control electrical stimulation delivered by the electrode system to the nervous system to provide a neurostimulation therapy to the patient (e.g. [0069]: therapy module coupled to the electrodes);
a system (S) for determining one or both of at least one physiological or at least one biological parameter (e.g. [0025]: IMD 16 may sense electrical cardiac signals attendant to the depolarization and repolarization of heart 14 via extravascular electrodes carried by lead 18. These signals may be referred to as electrocardiogram (ECG) signals or electrogram (EGM) signals, cardiac therapy module of IMD 16 may provide pacing pulses to heart 14 based on the electrical cardiac signals.,[0032]: A sensing module of IMD 16 may detect an arrhythmia using any suitable technique, such as techniques that rely on detected electrical cardiac signals generated by the depolarization and repolarization of heart 14, heart rate, or hemodynamic parameters, such as blood oxygen levels, blood pressure, stroke volume, and the like. IMD 16 may also sense other parameters, such as tissue perfusion, transthoracic impedance, cardiac impedance, and/or acoustic cardiac sound)
wherein the device is configured to derive a health status based at least in part on the at least one parameter, wherein the health status comprises a likelihood of a medical condition (e.g. [0025]: IMD 16 may detect an arrhythmia of heart 14, such as fibrillation of ventricles 26 and 28), and
wherein the system (S) comprises at least one element or shares at least one element associated with a neurostimulation therapy for determining the at least one parameter (e.g. [0069], [0075], [0078]: processor detects arrhythmia and controls the neurostimulation module, [0020] [0069]: common housing 54, power source 100, memory 82).
Regarding claims 3-5, Burnes teaches the device is configured to derive the health status based at least in part on one or both of a signature or a statistic of the at least one parameter over a predetermined period of time and the system (S) is configured to determine the at least one parameter based at least in part on a predetermined timing and wherein the system (S) is configured to determine one or both of an abrupt change or a gradual change of the at least one parameter (e.g. [0032]: sensing module of IMD 16 may detect an arrhythmia using any suitable technique, such as techniques that rely on detected electrical cardiac signals generated by the depolarization and repolarization of heart 14, heart rate, or hemodynamic parameters, such as blood oxygen levels, blood pressure, stroke volume, and the like. IMD 16 may also sense other parameters, such as tissue perfusion, transthoracic impedance, cardiac impedance, and/or acoustic cardiac sounds., [0081],[0082])
Regarding claim 6, Burnes teaches the device is configured to derive the health status based at least in part on comparing the at least one parameter with a parameter specific threshold (e.g. [0081]-[0082]: sensing threshold).
Regarding claim 7, Burnes teaches the device is configured to monitor the health status (e.g. e.g. [0032]: sensing module of IMD 16 may detect an arrhythmia using any suitable technique, such as techniques that rely on detected electrical cardiac signals generated by the depolarization and repolarization of heart 14, heart rate, or hemodynamic parameters, such as blood oxygen levels, blood pressure, stroke volume, and the like. IMD 16 may also sense other parameters, such as tissue perfusion, transthoracic impedance, cardiac impedance, and/or acoustic cardiac sounds., [0081],[0082).
Regarding claims 9 and 10, Burnes teaches an implantable neurostimulation device (100) according to claim 1 as discussed above, wherein the system (S) comprises at least one sensor and wherein the at least one sensor comprises at least one of the following: a temperature sensor (110), an evoked compound action potential sensor (120), an impedance sensor (130), a cardiac sensor (140), an activity sensor (150), or an accelerometer (e.g. [0095]: signals generated by an activity or motion sensor, such as an accelerometer, which may indicate the activity level or posture of patient 12).
Regarding claim 11, Burnes teaches an implantable neurostimulation device according to claim 1 as discussed above, wherein the at least one parameter comprises at least one of the following: a body temperature, an evoked compound action potential amplitude, an evoked compound action potential duration, an evoked compound action potential frequency component, an impedance, a heart rate (e.g. [0032]: A sensing module of IMD 16 may detect an arrhythmia using any suitable technique, such as techniques that rely on detected electrical cardiac signals generated by the depolarization and repolarization of heart 14, heart rate, or hemodynamic parameters, such as blood oxygen levels, blood pressure, stroke volume, and the like. IMD 16 may also sense other parameters, such as tissue perfusion, transthoracic impedance, cardiac impedance, and/or acoustic cardiac sounds), a heart rate variability, a body movement intensity, a daily step count, a gait, a body position (e.g. [0095]: signals generated by an activity or motion sensor, such as an accelerometer, which may indicate the activity level or posture of patient 12), a sleeping pattern, or a sleeping quality.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Burnes et al (U.S. Patent Application Publication Number: US 2010/0114195 A1, hereinafter “Burnes”) in view of Gaffari et al (U.S. Patent Application Publication Number: US 2017/0095670 A1, hereinafter “Ghaffari” – APPLICANT CITED).
Regarding claim 8, Burnes teaches the claimed invention as discussed above except for the device being configured to trigger an alert based at least in part on the health status.
In a similar field of endeavor, Ghaffari teaches a device that is configured to trigger an alert based at least in part on the health status (e.g. [0081]: the system can detect a nocturnal seizure (i.e. health status) from accelerometer data and cause a predefined action to occur such as sending an alert (e.g., an audible alarm, a text message or phone message) to a family member or care giver). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Burnes to send an alert to a caregiver based on the determined health status as taught by Ghaffari in order to provide the predictable results of alerting the family or caregiver of the patient’s status.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burnes et al (U.S. Patent Application Publication Number: US 2010/0114195 A1, hereinafter “Burnes”) in view of Li et al (U.S. Patent Application Publication Number: US 2022/00111211 A1, hereinafter “Li”).
Regarding claim 12, Burnes teaches the claimed invention as discussed above except for the at least one parameter comprises a perception threshold, and the system (S) is configured to determine the at least one parameter based at least in part on a manual input to the system.
In a similar field of endeavor, Li teaches a neurostimulation device (i.e. spinal cord stimulation (e.g. Abstract) that derives health status (i.e. heart rate variability e.g. [0004]) that comprises likelihood of a medical condition (i.e. pain [0004]) and at least one parameter comprises a perception threshold (i.e. ECAP e.g. [0004]), and the system (S) is configured to determine the at least one parameter based at least in part on a manual input to the system (e.g. [0035],[0036]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Burnes with the at least one parameter comprising a perception threshold, and the system (S) being configured to determine the at least one parameter based at least in part on a manual input to the system as taught by Li in order to provide the predictable results of further adjusting therapy as required by the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hill et al (U.S. Patent Application Publication Number: US 2002/0165586 A1, hereinafter “Hill”) teaches an implantable neurostimulation device comprising a system for determine a physiological parameter and determining a health status of the patient based on the parameter and shares at least one element associated with neurostimulation therapy for determining the at least one parameters (e.g. Abstract, [0051], Figs.1A-1C)
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 MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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