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 .
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 4th, 2025 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63551991, filed on February 9th, 2024. Examiner acknowledges the applicant’s claim for priority.
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 3-14, 16, 17 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.
The antecedent basis of the limitation “the neurostimulation action” in claims 3, 4, 5, 9, 12, and 13 seems indefinite since it is unclear if the limitation “the neurostimulation action” in claims 3, 4, 5, 9, 12, and 13 is the same as the limitation “a neurostimulator action” in claim 1. For the purpose of examination, “the neurostimulation action” in claims 3, 4, 5, 9, 12, and 13 has been interpreted as referring to “a neurostimulator action” in claim 1.
Claim 4 recites “estimating a confidence or a significance of dropping the neurostimulator; and /or estimating at least one of a confidence or significance of an expected patient risk or device harm”. The term “confidence or significance” in claim 4 is a relative term which renders the claim indefinite. The term “confidence or significance” 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. It is unclear what are the available measurements for “confidence or significance” are for an expected patient risk or device harm.
Claim 4 recites “an expected patient risk or device harm”. The terms “risk” and “harm” in claim 4 are relative terms which render the claim indefinite. The terms “risk” and “harm” are 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. It is unclear what type of events would be considered as an expected patient risk or device harm.
Claim 5 recites “and the unintended neurostimulator event the patient experiencing an unusual force that has a potential to adversely affect operation of the neurostimulator or effects of unaltered operation on the patient,” is missing a verb and the metes and bounds are unascertainable as written.
Claim 5 recites “an unusual force that has a potential to adversely affect operation of the neurostimulator”. The term “unusual” in claim 5 is a relative term which renders the claim indefinite. The term “unusual” 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. It is unclear what “force that has a potential to adversely affect operation of the neurostimulator” is considered usual or unusual.
The antecedent basis of the limitation “the intentional user action” in claims 6, 7, 8, 11, 14, 16, and 17 seems indefinite since it is unclear if the limitation “the intentional user action” in claims 6, 7, 8, 11, 14, 16, and 17 is the same as the limitation “an intentional user interaction” in claim 1. For the purpose of examination, “the intentional user action” in claims 6, 7, 8, 11, 14, 16, and 17 has been interpreted as referring to “an intentional user interaction” in claim 1.
Claim 10 depends from claim 8, which recites its action in the alternative. Thus, claim 10’s “the wireless communication session” lacks antecedent basis.
The terms “protective state” and “lower-power state ” in claim 14 are relative terms which render the claim indefinite. The terms “protective state” and “lower-power state ” are 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. The specification describes protective states, lower-power states, and transitions between low and nominal or operating power states. See, e.g., paragraphs [0017], [0035], and [0069]. However, the claim language does not clearly define the boundaries of these states.
The state of the neurostimulator is rendered indefinite by the use of the relative term “protective state” and in claim 14. The state of the neurostimulator is rendered indefinite by the use of the relative term “protective state” and “lower-power state ” in claim 14.
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 1-16 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention a judicial exception without significantly more.
Step 1
The claims recite subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1-16 and 18-20 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 1 states:
A method performed using an accelerometer within a neurostimulator, the method including:
monitoring an output of the accelerometer;
detecting an event from the output of the accelerometer, wherein the event includes an intentional user interaction with the neurostimulator or an unintended neurostimulator event;
and performing a neurostimulator action in response to the detected event.
At least claim 1 recite limitations (bolded above), as drafted, describe a process that, under the broadest reasonable interpretation, includes performance of the limitations in the mind or organizing human activities. The limitations of “accelerometer” and “neurostimulator” are associated with data being monitored and detected but are not implementing these steps. While the specification does disclose that steps of applicant’s invention are computer-implemented steps (see [0071] of the USPGPub. version of the specification), current method claim does not recite or require computer to perform any of the steps recited in claim 1. That is, nothing in the claim precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity. MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, the claim encompasses a medical professional observing and evaluating a patient’s movement data and recommending or communicating a therapy to a patient.
Independent claims 19 and 20 recites similar steps of monitoring, detecting, and performing as discussed above for claim 1 and these claims fall under the same category of an abstract idea and follows the same rationale as claim 1.
Step 2A Prong Two
This judicial exception of “Mental Processes” or “Organizing Human Activity” is not integrated into a practical application. Independent claim 1’s method does not include any additional elements. Independent claims 19 and 20 includes non-transitory computer readable medium, a waveform generator, and a controller. The non-transitory computer readable medium, a waveform generator, and a controller will be treated as a generic computer component (see [0071] of the USPGPub. version of the specification). In particular, these additional elements do not integrate the abstract idea into a practical application because the additional elements: amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f)). Claim 20 further recites “accelerometer”, which recited at a high level of generality and is nothing more than pre-solution activity of data gathering, which does not amount to an inventive concept.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in [0071] does not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
The additional element of “accelerometer” amount to nothing more than pre-solution activity of data gathering, which does not amount to an inventive concept as set forth above. The specification discloses variety of accelerometers available in medical device technology (see [0004]). As such, the additional element of “accelerometer” is well understood, routine, conventional activity in the medical device technology.
Regarding claim 10, which depends from claim 8, elements recited in claim 10 (“external pulse generator…computer”) do not limit the communication protocol recited in claim 8.
Regarding claims 12 and 13, the limiting where neurostimulation action is taking place does not fundamentally change the act of recommending or communicating a therapy to a patient, which is interpreted as organizing human activity.
Dependent claims 2-9, 11, 14-16, and 18 recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 2, reciting particular aspects of how “wherein the event includes the unintended neurostimulator event and the neurostimulator is external to a patient, and the unintended neurostimulator event includes dropping the neurostimulator” may be performed independently but for recitation of generic computer components).
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
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.
(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.
Claims 1 and 6-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al. (US20230310856).
Regarding claim 1, Shelton teaches a method performed using an accelerometer within a neurostimulator, the method including: ([0004] “methods for VNS described herein” and [0046] “The VNS stimulator 204 may include a motion sensor 212 (e.g. a one- or two-axis accelerometer”) monitoring an output of the accelerometer; ([0049] “VNS stimulator 110 can … assert a discrete output when the double-tap has been detected.”) detecting an event from the output of the accelerometer, ([0004] “taps and/or bodily gestures that are sensed by a motion sensor”) wherein the event includes an intentional user interaction [i.e., bodily gestures above] with the neurostimulator or an unintended neurostimulator event ([0052] “the VNS system 100 may … avoid inadvertent modulation”); and performing a neurostimulator action in response to the detected event. ([0004] “users to manually adjust stimulation parameters when needed using a predefined pattern of tactile input and/or voice commands”)
Regarding claim 6, Shelton teaches all of the limitations of claim 1. Shelton also teaches wherein the neurostimulator is external to a patient, ([0042] “part of or within the VNS stimulator 110, a separate external or implanted device”) and the event includes the intentional user action [i.e., tactile input] with the neurostimulator. ([0004] the motion sensor … can provide a fast and accurate means for controlling VNS”); see optionally [0004] “to manually adjust stimulation parameters when needed using a predefined pattern of tactile input”)
Regarding claim 7, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the intentional user action includes at least one … tapping the neurostimulator with one tap or a temporal pattern of two or more taps ([0015] “the tactile input comprises a double-tap or a triple-tap detected by the motion sensor”; see also [0051]).
Regarding claim 8, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the performing the neurostimulator action in response to the intentional user action with the neurostimulator includes: initiating a communication protocol to create a wireless communication session with the neurostimulator ([0042] “VNS system 100 may include a motion sensor … capable of communicating with the VNS stimulator 110 or other components of the VNS system 100 via a wired or wireless connection)”)… or transitioning to an implantation mode. ([0004] “users to manually adjust stimulation parameters when needed using a predefined pattern of tactile input”)
Regarding claim 9, Shelton teaches all of the limitations of claim 8. Shelton also teaches wherein the neurostimulation action includes the initiating the communication protocol, which includes sending advertising packets in response to the intentional user action. ([0047] “VNS stimulator 204 … includes a wireless receiver configured to receive wireless signals, e.g., Bluetooth Low Energy, from a source external to the patient (e.g., for communication with an external or implanted electronic device” where Bluetooth uses advertisement packets for communicating device pairing in response to tactile input)
Regarding claim 10, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the wireless communication session is between the neurostimulator and … a clinician programmer (CP), a remote control (RC) or a digital application on a phone, tablet or computer. ([0017 “an external device (e.g., a dedicated controller, or software on a computer, tablet, mobile phone, or smartphone paired with or otherwise communicatively linked with the VNS system).”)
Regarding claim 11, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the performing the neurostimulator action in response to the intentional user action with the neurostimulator includes performing a measurement [i.e., events recorded] using the neurostimulator. [0047] “VNS stimulator 204 further may include a transceiver… to receive information including events recorded or detected by one or more external sensors”)
Regarding claim 12, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the neurostimulation action [i.e., deactivation] is performed during device manufacture, distribution or shipping. ([0048] “controller 220 may access the memory 214 to receive and process instructions to … temporarily deactivate the pulse generator” or [0013] “a motion sensor and the controller is configured to: a) place the system in a training mode wherein the system is configured to obtain training data” which occurs during quality checks for manufacturing)
Regarding claim 13, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the neurostimulation action is performed in operating room or in clinic. ([0042] “the VNS system 100 may… detect tactile input, … from the human subject, a clinician, an operator, or from the environment. These signals may be used to control the VNS system”)
Regarding claim 14, Shelton teaches all of the limitations of claim 6. Shelton also teaches wherein the performing the neurostimulator action in response to the intentional user action includes causing the neurostimulator to turn off, causing the neurostimulator to enter a sleep state, a protective state, or lower-power state. ([0048] “controller 220 may access information including physical events detected by one or more implanted or external sensors (e.g., by a motion sensor or acoustic sensor as described herein). The processor may evaluate the detected events and … ramp-off rate of the electrical stimulation pulses” comprises using less power when turning off)
Regarding claim 15, Shelton teaches all of the limitations of claim 1. Shelton also teaches wherein the neurostimulator is implanted in a patient, and the event includes the intentional user action with the neurostimulator. ([0004] “users to manually adjust stimulation parameters when needed using … bodily gestures that are sensed by a motion sensor”)
Regarding claim 16, Shelton teaches all of the limitations of claim 15. Shelton also teaches wherein the intentional user action includes a tap or one or more taps applied to the patient over the neurostimulator. ([0004] “users to manually adjust stimulation parameters when needed using … taps”)
Regarding claim 17, Shelton teaches all of the limitations of claim 15. Shelton also teaches wherein the neurostimulator action includes delivering a dose of neurostimulation, changing a dose of neurostimulation, switching a neurostimulation program, modifying a neurostimulation program schedule, or changing neurostimulator operating modes. ([0006] “stimulation parameter comprises a pulse amplitude, pulse width, duty cycle, pulse frequency, ramp-on rate, and/or ramp-off rate of the electrical stimulation pulses.” And [0015] “tactile input comprises a double-tap or a triple-tap … to modulate the at least one stimulation parameters” and [0022] “the value of the increase (or the decrease) is selected based on one or more preset values, e.g., stored in a profile on the VNS system”)
Regarding claim 18, Shelton teaches all of the limitations of claim 15. Shelton also teaches wherein the neurostimulator action includes uploading data from the neurostimulator. ([0047] VNS stimulator 204 further may include a transceiver/receiver… provide feedback signals to external sources using data generated”).
Regarding claim 19, Shelton teaches a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform ([0040] “the functions may be stored on or encoded as one or more instructions or code on a computer-readable medium”) a method performed using an accelerometer within a neurostimulator ([0046] “The VNS stimulator 204 may include a motion sensor 212 (e.g. a one- or two-axis accelerometer”), the method of claim 1 (see above).
Regarding claim 20, Shelton teaches a system comprising a neurostimulator, wherein the neurostimulator includes: a waveform generator configured to deliver neurostimulation ([0031] “a VNS stimulator including a pulse generator and a controller configured to modulate one or more parameters”); a controller operably connected to the waveform generator to control the neurostimulation ([0031] “a VNS stimulator including a pulse generator and a controller configured to modulate one or more parameters”); and an accelerometer, ([0046] “The VNS stimulator 204 may include a motion sensor 212 (e.g. a one- or two-axis accelerometer”) wherein the controller is configured to ([0005] “VNS stimulator comprises a controller configured to”): monitor an output of the accelerometer ([0049] “VNS stimulator 110 can … assert a discrete output when the double-tap has been detected.”); detect an event from the output of the accelerometer, ([0004] “taps and/or bodily gestures that are sensed by a motion sensor”) wherein the event includes at least one intentional user interaction [i.e., bodily gestures above] with the neurostimulator or an unintended neurostimulator event; ([0052] “the VNS system 100 may … avoid inadvertent modulation”) and perform a neurostimulator action in response to the detected event. ([0004] “users to manually adjust stimulation parameters when needed using a predefined pattern of tactile input and/or voice commands”)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (US20230310856) as applied to claim 1 above, and further in view of Galarneau et al. (US20200380840).
Regarding claim 2, Shelton teaches all of the limitations of claim 1. Shelton does not explicitly teach, as taught by Galarneau wherein the event includes the unintended neurostimulator event and the neurostimulator is external to a patient ([0019] “A medical device, which may be implantable or wearable is configured to detect… an accelerometer spike… in a variety of medical devices, which may include neurostimulator”), and the unintended neurostimulator event includes dropping the neurostimulator. ([0020] “ medical device system performing the techniques disclosed herein at least includes an accelerometer producing a signal correlated to … patient body motion”). Shelton and Galarneau both come from the same field of invention of treating patients with neurostimulation devices. Galarneau explains “a fall may be related to an undiagnosed medical condition or a medical condition that has worsened” [0003] and “to increase specificity of fall detection by improving discrimination between posture and acceleration signals corresponding to a fall” would increase the accuracy of fall detection for the purpose of improving a patient’s treatment protocol. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the neurostimulator in Shelton’s reference to measure the device’s fall rate, as taught and suggested by Galarneau, with a reasonable expectation of success, for the purpose of improving a patient’s treatment protocol.
Regarding claim 3, Shelton and Galarneau as a combination teach all of the limitations of claim 2. Galarneau also teaches wherein the performing the neurostimulation action in response to the detected event includes initiating communication, creating a log, or adjusting or stopping activity in response to dropping the neurostimulator. ([0051] “Control circuit 80 performs a response to a fall detection which may include storing fall related data in memory 82, generating an alert or notification … and/or adjusting a therapy delivered by therapy delivery circuit (which may include turning on or off a therapy).”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the neurostimulator in Shelton’s reference to alter device activity based on the device’s fall rate, as taught and suggested by Galarneau, with a reasonable expectation of success, for the purpose of improving a patient’s treatment protocol.
Regarding claim 4, Shelton and Galarneau as a combination teach all of the limitations of claim 2. Galarneau also teaches wherein the performing the neurostimulation action in response to the detected event includes: estimating at least one of a confidence or a significance of dropping the neurostimulator; and/or estimating at least one of a confidence or significance of an expected patient risk or device harm. ([0104] “Fall data… transmission and review … may include trends in fall data, such as frequency of fall detections and/or trend in fall severity based on the trend in fall recovery time durations so that a clinician can recognize if the patient is falling more often”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the neurostimulator in Shelton’s reference to estimate fall severity based on the device’s fall rate, as taught and suggested by Galarneau, with a reasonable expectation of success, for the purpose of improving a patient’s treatment protocol.
Regarding claim 5, Shelton teaches all of the limitations of claim 1. Shelton does not explicitly teach, as taught by Galarneau, wherein the event includes the unintended neurostimulator event and the neurostimulator is internal to a patient ([0019] “A medical device, which may be implantable or wearable is configured to detect… an accelerometer spike… in a variety of medical devices, which may include neurostimulator”), and the unintended neurostimulator event the patient experiencing an unusual force that has a potential to adversely affect operation of the neurostimulator or effects of unaltered operation on the patient, wherein the performing the neurostimulation action in response to the detected event includes adjusting or stopping activity in response to the unusual force. ([0104] “Fall data… transmission and review … may include trends in fall data, such as frequency of fall detections and/or trend in fall severity based on the trend in fall recovery time durations so that a clinician can recognize if the patient is falling more often”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the neurostimulator in Shelton’s reference to estimate fall severity based on the device’s fall rate, as taught and suggested by Galarneau, with a reasonable expectation of success, for the purpose of improving a patient’s treatment protocol.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Angara et al. (US20160271405) discloses an implantable pulse generator with a touch indicator and 3 axis accelerometer that changes programming based on inputs.
Gonzani et al. (US20190022386) discloses a transcutaneous electrical nerve stimulation in a user that uses Bluetooth connectivity, monitors electrical impedance, and more.
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
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, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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