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 .
The current application has the priority date of 05/16/2019 according to the priority chain on the record.
Claim Status
As per preliminary claim amendment received on 05/14/2024, claims 1-34 have been cancelled, and claims 35-60 are pending.
Claim Objection
Claim 57 is objected to because of the following informalities: the phrase “an implanted movement sensor” is recited twice. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 35-51 and 60 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claims 35 and 61, individually recite, an implantable pulse generator, and thus, claims 35-51 and 60 all fall under one of the four patent eligible categories.
To Step 2(a) prong 1:
Independent claim 1 recites:
An implantable pulse generator comprising:
a non-transitory computer readable memory comprising instructions to:
calculate a heart rate parameter from cardiac data received from a cardiac sensor;
calculate a disease activity parameter from disease activity data received from a disease activity sensor;
calculate a bodily activity parameter from bodily activity data received from a bodily activity sensor;
determine an autonomic nervous system state, physiological state, and/or disease state of the patient based on the heart rate parameter, the disease activity parameter, and the bodily activity parameter; and
adjust a nerve stimulation parameter of a stimulation signal based on the determined autonomic nervous system state, the physiological state, and/or the disease state; and
a microcontroller configured to execute the instructions.
Under the broadest reasonable interpretation, these italicized limitations, i.e. the various calculate, determine and adjusts steps, can be wholly performed by a person mind via a series of mental observations, judgements and calculations. In particularly, a person can read or observe sensor readings of cardiac data, disease activity data, and bodily activity data, the person can then mentally determine and/or calculate the heart rate parameter, disease activity parameter and bodily activity parameter; the person can also mental determine mentally determine an autonomic nervous system state, physiological state, and/or disease state of a patient, and lastly, the person can also adjust a nerve stimulation parameter based on the previous calculations. Accordingly, claim 35 is directed to a judicial exception including one or more abstract ideas under mental process buckets.
Applying the same rationale, independent claim 60, is also directed to a judicial exception including one or more abstract ideas under mental process buckets.
As for dependent claims 36-61, these claims recite limitations that refine or further limit the “heart rate parameter”, the “cardiac data”, the “disease activity parameter”, the “disease activity sensor”, the “bodily activity parameter”, the “adjusted stimulation parameter”, the stimulation signal”; currently, all dependent claims fall under one or more abstract ideas under the same mental process buckets as independent claim 35 because these limitations only pertain to insignificant pre-solution activity, i.e. data gathering steps, and/or post-solution activity.
Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claims 35 and 60 recites the additional bolded limitations, i.e. “implantable pulse generator” (IPG), “non-transitory computer readable memory”, and a “microcontroller”. As drafted, the recited IPG (in both claims 35 and 60) do not actually include any sensing and/or stimulation/therapeutic elements, and also does not recite structures for implantation. In fact, in both claims 35 and 60, the IPG merely comprises said “non-transitory computer readable memory”, and a “microcontroller”; thus, under BRI, the recited IPG is functionally equivalent to a computer, which comprises memory, and a processor. These additional elements do not practically integrate the judicial exception because these elements do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the certain methods of organizing human activity grouping.
Dependent claims 35-51 do not recite additional element(s) which practically integrate the recited judicial exception into a practical application of the exception.
Under Step 2b: The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As such, claims 35-51 and 60 are rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
Note to applicant: Independent claims 52 and 55 recite an implantable signal delivery device for delivering stimulation signal/treatment, and thus satisfy practical integration under step 2A prong 2.
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.
Claims 35-59 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, line 9, “the patient” lacks proper antecedent basis in the claim. Dependent claims 48 and 49 inconsistently uses the phrase “a patient” and “the patient”, the Applicant is advised to amend accordingly.
Regarding claim 1, the claim clause “determine an autonomic nervous system state, physiological state and/or disease state of the patient based on the heart rate data, the disease activity parameter and the bodily activity parameter” is vague and indefinite. In here the claim requires calculating up to three types of outputs (i.e. “an autonomic nervous system state, physiological state and/or disease state” based on all three types of inputs (i.e. “based on the heart rate data, the disease activity parameter and the bodily activity parameter”). It is unclear to the Examiner as to whether all three types of outputs are calculated from all three inputs, or a combination of some of the three types of inputs. If all three inputs are used for each of the three types of output, how are each output calculated, and if specific algorithms are involved. The Applicant is advised to break this claim clause into a plurality of steps to clarify.
Independent claim 55 recite “determine an autonomic nervous system state, physiological state, and disease state of the patient based on the heart rate parameter, the disease activity parameter, and the bodily activity parameter”, this claim clause is rejected as vague and indefinite under the same rationale discussed to claim 35 immediately above.
In claim 41, the terms “about 1 hour” and “about 12 hours” are relative terms which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 48, the limitations “the production of pro-inflammatory cytokines” and “the production of anti-inflammatory” lack proper antecedent basis in the claim.
Other dependent claims are rejected as indefinite based on a rejected independent claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 42-45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 42-45, these claims solely recite limitations pertaining to the “disease activity sensor.” However claim 35, from which 42-45 depends, does not positively recite the “disease activity sensor” as part of the “implantable pulse generator.” Since the “implantable pulse generator” does not include the “disease activity sensor”, dependent claims 42-45 fail to further limit the base claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretations
Claim 48 recites “wherein the stimulation signal is configured to suppress the production of pro-inflammatory cytokines, increase the production of anti-inflammatory cytokines, and/or reduce the sympathetic tone in a patient that has a chronic gastrointestinal disorder, a chronic auto-immune disease, or a metabolic disorder.” The limitations following ‘configured to’ are treated as intended use/functional language of the “stimulation signal.”
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 the33 claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 35-44 and 46-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al. US 2017/0203103 A1 (hereinafter “Levine”, cited in IDS).
Regarding claim 35, Levine discloses an implantable pulse generator (see Abstract and [0106:1st sentence] implanted neurostimulator, e.g. microstimulator, IPG, etc.) comprising:
a non-transitory computer readable memory ([0160] method and user interface implemented as software, hardware or firmware, stored on non-transitory computer readable memory) comprising instructions to:
calculate a heart rate parameter ([0010, 0039] physiological metric, e.g. heart rate, heart rate variability/HRV;) from cardiac data (ECG) received from a cardiac sensor ([0039] electrodes; also see [0107]);
calculate a disease activity parameter (biomarker metric of inflammatory disease state) from disease activity data (e.g. temperature, cytokine level, and memory T cell level) received from a disease activity sensor ([0043, 0124, 0125, 0148] measured by the built-in analyte sensor at the microstimulator or thermometer, [0107] measured by a separate sensor, parameter received at microstimulator);
calculate a bodily activity parameter (activity metric) from bodily activity data (body motion) received from a bodily activity sensor ([0147- 0151] motion sensor, accelerometer);
determine an autonomic nervous system state, physiological state, and/or disease state of the patient based on the heart rate parameter, the disease activity parameter, and the bodily activity parameter ([0093] “Described herein are methods and apparatuses in which one or more metrics, including biomarker metrics, activity metrics, physiological metrics, or the like, may be used to determine which patients may be treated by VNS and/or the dose or level of applied VNS…”; [0151: 2nd to last sentence] “physical activity level can be used to determine a disease state.” Also see [0158] measured sensor data and received data are correlated to a patient’s disease state, and used to modulate stimulation parameter in a closed loop manner); and
adjust a nerve stimulation parameter ([0010-0011] vagus nerve stimulation signal) of a stimulation signal based on the determined autonomic nervous system state, the physiological state, and/or the disease state (see immediately above [0093, 0151, 0158] determining patient disease state and modulate stimulation signal and dose); and
a microcontroller configured to execute the instructions ([0160] computer instructions executable by a processor).
Regarding claim 36, Levine discloses the implantable pulse generator of claim 35, wherein the heart rate parameter comprises a frequency-domain parameter. ([0044] “determining a ratio of high frequency to low frequency components of heart rate variability.”)
Regarding claim 37, Levine discloses the implantable pulse generator of claim 36, wherein the frequency-domain parameter comprises a power of a low frequency (LF) band, a power of a high frequency (HF) band, or an LF/HF power ratio. ([0044] “determining a ratio of high frequency to low frequency components of heart rate variability.”)
Regarding claim 38, Levine discloses the implantable pulse generator of claim 35, wherein the cardiac data is electrocardiographic or photoplethysmographic data. ([0039: 3rd sentence], [0107: 3rd sentence] ECG)
Regarding claim 39, Levine discloses the implantable pulse generator of claim 35, wherein the disease activity parameter comprises an inflammatory disease activity parameter or an oxidative stress activity parameter. ([0007-0008] inflammatory disease metric, e.g. inflammatory biomarker signal)
Regarding claim 40, Levine discloses the implantable pulse generator of claim 35, wherein the disease activity parameter comprises one or more of: an average of inflammatory disease activity data, a percentage of time with elevated inflammatory disease activity, an amplitude of oxidative stress activity, and a percentage of time with elevated oxidative stress activity. (see [0137: last sentence] percentage increase of memory Treg cells- which is an inflammatory biomarker; also see [0098] monitoring percentage of time of inflammatory reflex)
Regarding claim 41, Levine discloses the implantable pulse generator of claim 35, wherein the disease activity parameter is calculated over a period of time of about 1 hour to about 12 hours. ([0008] “metric(s) taken from the patient immediately or at one or more time intervals thereafter (e.g., within the first hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours”)
Regarding claim 42, Levine discloses the implantable pulse generator of claim 35, wherein the disease activity sensor is an implanted core body temperature sensor and the disease activity data is core body temperature data. ([0107] microstimulator is an implanted device, and has a built-in temperature sensor for detecting temperature, e.g. nerve, body, blood, or at the implanted site, this is taken to encompass “implanted core body temperature sensor/data” in this claim. Also see [0148:2nd sentence] “… core body temperature may be used to detect changes in body temperature indicative of disease states.”)
Regarding claim 43, Levine discloses the implantable pulse generator of claim 42, wherein the disease activity parameter comprises an average core body temperature or a percentage of time with elevated core body temperature. (see [0148])
Regarding claim 44, Levine discloses the implantable pulse generator of claim 35, wherein the disease activity sensor and the bodily activity sensor are the same sensor. ([0149-0150] both rheumatoid arthritis (RA) and bodily activity/motion can be detected by motion sensor/accelerometer)
Regarding claim 46, Levine discloses the implantable pulse generator of claim 35, wherein the bodily activity parameter comprises a respiratory activity parameter, a metabolic activity parameter, a gastrointestinal activity parameter, or a circadian rhythm parameter. ([0041] respiratory movements)
Regarding claim 47, Levine discloses the implantable pulse generator of claim 35, wherein the adjusted stimulation parameter comprises one or more of amplitude, frequency, pulse width, burst interval, and elapsed duration. ([0043: last sentence] “wherein increasing or decreasing the stimulation may comprise increasing or decreasing one or more of: the frequency of stimulation, the duration of stimulation, the burst duration, the amplitude of electrical stimulation, and the peak-to-peak voltage of the stimulation.” Modulating the stimulation signal include all of amplitude, frequency, pulse width, burst interval and elapsed duration; also see [0046, 0048, 0101-0104] and Table 1 and Table 2 for microstimulator parameters)
Regarding claim 48, Levine discloses the implantable pulse generator of claim 35, wherein the stimulation signal is configured to suppress the production of pro-inflammatory cytokines, increase the production of anti-inflammatory cytokines, and/or reduce the sympathetic tone in a patient that has a chronic gastrointestinal disorder, a chronic auto-immune disease, or a metabolic disorder. (Intended use claim, see [0092-0093] stimulation intended to suppress inflammatory response, e.g. “A reduction in the level or release of an inflammatory cytokine, such as TNF for example, may indicate that the patient is responding to VNS, and/or may give an indication of the level of response”)
Regarding claim 49, Levine discloses the implantable pulse generator of claim 35, wherein the disease activity data is inflammatory disease activity data (see rejection to claim 35, [0043, 0124, 0125] (chronic) inflammatory disease), the disease activity parameter is a time-dependent disease activity parameter ([0104] time-dependent inflammatory disease), the implantable pulse generator is configured to determine a disease state of the patient, and the disease state is an inflammatory disease state. ([0093, 0151, 0158] determining patient disease state and modulate stimulation signal and dose)
Regarding claim 50, Levine discloses the implantable pulse generator of claim 49, wherein the inflammatory disease state is early inflammatory response, flare of inflammatory disease activity, no flare in inflammatory disease activity, or late inflammatory response. ([0150] inflammatory flare-ups)
Regarding claim 51, Levine discloses the implantable pulse generator of claim 50, wherein the inflammatory disease state is flare of inflammatory disease activity, and wherein in the inflammatory disease state of flare, inflammatory disease activity in an inflammatory, auto-immune, or metabolic disease is increased. ([0150] inflammatory flare-ups)
Regarding claim 52, Levine discloses a system for delivering an electrical stimulus to a nerve of a patient comprising:
the implantable pulse generator of claim 35 (see rejection to claim 35 above);
the cardiac sensor ([0039] electrodes; also see [0107]);
the disease activity sensor ([0043, 0124, 0125, 0147-0148] measured by the built-in sensor at the microstimulator, e.g. implanted core body temperature, [0107] measured by a separate sensor, parameter received at microstimulator);
the bodily activity sensor ([0147- 0151] motion sensor, accelerometer) and
an implantable signal delivery device (electrodes of the microstimulator, see Fig. 1D and [0037]) configured to deliver the stimulation signal to the nerve.
Regarding claim 53, Levine discloses the system of claim 52 further comprising a temporary signal delivery device configured to deliver a screening stimulation signal to the nerve. ([0121] “Programs may be loaded into one of four available slots and can be tested before they start running”; [0140] “In other embodiments, the minimally invasive electrical stimulation used in the screening test can be delivered directly to the nerve using a needle electrode.”)
Regarding claim 54, Levine discloses the system of claim 53, wherein the stimulation signal is delivered using the implantable signal delivery device or the temporary signal delivery device. ([0037, 0092-0093] microstimulator adapted to apply therapeutic stimulation to implanted site. Alternatively, [0140] “In other embodiments, the minimally invasive electrical stimulation used in the screening test can be delivered directly to the nerve using a needle electrode.” In here, the needle electrode is taken to encompass “temporary signal delivery device” in this claim.)
Regarding claim 55, Levine discloses a system (see Fig.1D) for delivering an electrical stimulus to a nerve of a patient ([0106]) comprising:
a cardiac sensor ([0039] electrodes; also see [0107]);
an activity sensor ([0147- 0151] motion sensor, accelerometer);
an implantable signal delivery device (electrodes of the microstimulator, see Fig. 1D and [0037]) configured to deliver a stimulation signal to the nerve; and
an implantable pulse generator ([0106:1st sentence] implanted neurostimulator, e.g. microstimulator, IPG, etc.) comprising a microcontroller ([0160] processor) configured to:
receive cardiac data (ECG) from the cardiac sensor and calculate a heart rate parameter ([0010, 0039] physiological metric, e.g. heart rate, heart rate variability/HRV) from the cardiac data;
receive activity data (body motion data) from the activity sensor and calculate a disease activity parameter ([0150] rheumatoid arthritis (RA) state exhibits less overall body motion, detected by motion sensor/accelerometer) and a bodily activity parameter from the activity data ([0149] physical motion detected by motion sensor/accelerometer);
determine an autonomic nervous system state, physiological state, and disease state of the patient based on the heart rate parameter, the disease activity parameter, and the bodily activity parameter ([0093] “Described herein are methods and apparatuses in which one or more metrics, including biomarker metrics, activity metrics, physiological metrics, or the like, may be used to determine which patients may be treated by VNS and/or the dose or level of applied VNS…”; [0151: 2nd to last sentence] “physical activity level can be used to determine a disease state.” Also see [0158] measured sensor data and received data are correlated to a patient’s disease state, and used to modulate stimulation parameter in a closed loop manner);
adjust a nerve stimulation parameter of a stimulation signal ([0010-0011] vagus nerve stimulation signal) based on the determined autonomic nervous system state, physiological state, and/or disease state (see immediately above [0093, 0151, 0158] determining patient disease state and modulate stimulation signal and dose); and
instruct the implantable signal delivery device to deliver an adjusted stimulation signal comprising the adjusted nerve stimulation parameter ([0037, 0092-0093] microstimulator adapted to apply therapeutic stimulation to implanted site.).
Regarding claim 56, Levine discloses the system of claim 55, wherein the cardiac sensor is an implanted electrocardiographic electrode ([0039] implanted electrodes in the microstimulator; also see [0107]) or external diagnostic device configured to measure values of the patient's heart rate.
Regarding claim 57, Levine discloses the system of claim 55, wherein the activity sensor comprises one or more of: an implanted core body temperature sensor ([0107] microstimulator is an implanted device, and has a built-in temperature sensor for detecting temperature, e.g. nerve, body, blood, or at the implanted site, this is taken to encompass “implanted core body temperature sensor/data” in this claim. Also see [0148:2nd sentence] “… core body temperature may be used to detect changes in body temperature indicative of disease states.”), an implanted electromyographic electrode, an implanted movement sensor ([0147- 0151] motion sensor, accelerometer in the implanted microstimulator), an implanted non-enzymatic electrochemical sensor, an implanted oxygenation sensor, an implanted movement sensor, and external diagnostic device.
Regarding claim 58, Levine discloses the system of claim 55, wherein the adjusted nerve stimulation parameter comprises one or more of a stimulation amplitude, a pulse width, a frequency, a burst interval, and an elapsed stimulation duration. ([0043: last sentence] “wherein increasing or decreasing the stimulation may comprise increasing or decreasing one or more of: the frequency of stimulation, the duration of stimulation, the burst duration, the amplitude of electrical stimulation, and the peak-to-peak voltage of the stimulation.” Modulating the stimulation signal include all of amplitude, frequency, pulse width, burst interval and elapsed duration; also see [0046, 0048, 0101-0104] and Table 1 and Table 2 for microstimulator parameters)
Regarding claim 59, this claim is rejected by Levine, under the same rationale as discussed to claim 53 above.
Regarding claim 60, this claim is rejected by Levine, under the same rationale as discussed to claim 55 above.
Allowable Subject Matter
Claim 45 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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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.
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
February 21, 2026