Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 24, 27-28, 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over single reference 7660628 to Libbus et al. (hereinafter “Libbus”).
Regarding claim 24. (New) Libbus discloses a system for determining stimulus protocols (Fig. 11; Col 1, ln 52-55, col. 15 lines 37- 67 and col. 16 lines 1-9), the system comprising: a processor operatively coupled to a memory configured to store computer-readable instructions that, when executed by the processor, cause the processor to perform one or more operations comprising (fig 11, 1152 memory, 1159 processor/controller; col. 14 lines 50-66, col. 15 lines 37-67 and col. 16 lines 1-9) receiving a physiological input value (measured cardiac function such as blood pressure); calculating a pacing rate based on the physiological input value (inherent to modulation of CRM and neural stimulation delivery based on cardiac function measurements); determining, based on the pacing rate, one or more of a supra-threshold stimulus protocol to produce cardiac pacing and stimulation of one or both of local sympathetic tissue or parasympathetic tissues to modify the physiological input value and a sub-threshold stimulus protocol to produce feedback inhibition of a portion of an autonomic nervous system to modify the physiological input value (neural stimulation therapy only; col. 11 lines 36-54, col. 18 lines 44-51, 64-67, and col. 19 lines 1-17, Figs. 14A-14C, col. 17 lines 58-67 and col. 18 lines 1-21); determining, for the one or more of the supra-threshold stimulus protocol and the sub- threshold stimulus protocol, a respective composite amplitude of pacing stimulus, frequency of sub-pulses, duration of sub-pulses, and refractory period between a current pacing stimulus and a subsequent pacing stimulus (CRM therapy combined with neural stimulation therapy; col. 9 lines 54- 67, col 10 lines 1-13 and col. 11 lines 48-54; Figs. 14A-14C, col. 17 lines 58-67 and col. 18 lines 1-21); and transmitting, to a pacemaker for pacing a heart, the one or more of the supra-threshold stimulus protocol and the sub-threshold stimulus protocol, wherein the pacemaker is configured to pace the heart at a new pacing rate based on the one or more of the supra-threshold stimulus protocol and the sub-threshold stimulus protocol and the respective composite amplitude of pacing stimulus, frequency of sub-pulses, duration of sub-pulses, and refractory period (Id, col 3, ln 51 “delivers a stimulating waveform for cardiac pacing”).
Regarding claim 27. (New) The system of claim 24, wherein the physiological input value is a blood pressure value (Col 9, ln 17-40, col 13, ln 60-67, etc.).
Regarding claim 28. (New) The system of claim 24, wherein the calculating the pacing rate comprises: comparing the physiological input value to a target physiological input value; and determining the pacing rate based on comparing the physiological input value to the target physiological input value (Col 15, ln 25-27).
Regarding claim 32. (New) The system of claim 24, wherein the computer-readable instructions, when executed by the processor, cause the processor to perform one or more further operations comprising: receiving autonomic nervous system (ANS) activity from one of a direct sensor or an indirect function; and calculating the pacing rate further based on the ANS activity (col 6, ln 1-6 “The ANS includes, but is not limited to, the sympathetic nervous system and the parasympathetic nervous system”).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Libbus as applied to claims above, and further in view of US 20170157399 to Anderson et al. (hereinafter “Anderson”).
Regarding claim 25. (New) The system of claim 24, but fails to disclose wherein the respective composite amplitude of pacing stimulus is reached based on a number of sub-pulses, the number of sub-pulses having amplitudes totaling the composite amplitude of pacing stimulus.
However, the use of multiple sub-pulses to elicit CRM therapy or neural stimulation is considered well-established in the art of cardiac pacemakers (col. 9 lines 17-35, col. 18 lines 44-51)
Anderson, from a similar field of endeavor teaches that it is known to provide multiple individual electrical pulses in succession within a selected pacing pulse with to produce a composite, low voltage pacing pulse having an overall pulse width that is long enough to successfully pace the heart… (para 0032). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention seeking to optimize the stimulation waveforms taught in Libbus with the known teachings of Anderson and/or during routine experimentation with the frequency and amplitude of CRM and neural stimulation protocols to provide the predictable result of producing a composite, low voltage pacing to successfully pace the heart.
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Libbus as applied to claims above, and further in view of US 20170333712 to Chen
Regarding claim 30. (New) Libbus discloses the system of claim 24, wherein the computer-readable instructions, when executed by the processor, cause the processor to perform one or more further operations comprising: receiving a sympathetic or parasympathetic activity; and calculating the pacing rate further based on the skin sympathetic or parasympathetic activity (col 6, ln 1-6 “The ANS includes, but is not limited to, the sympathetic nervous system and the parasympathetic nervous system”) but fails to disclose using skin ANS.
Chen, from a similar field of endeavor teaches the electrical activity in the nerves that innervate the skin occurs at higher frequencies and lower amplitudes compared to the electrical signals generated in the cardiac muscle during a heartbeat. As such, processor 116 may be configured to identify and monitor the electrical signals corresponding to specific signals in the subject, such as nerve or cardiac activity, by processing data samples received from the signal detector 104. That is, the processor 116 may apply appropriate filters, such as low-pass filters, high-pass filters (para 0050-0057). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Libbus with the teachings of Chen to provide the predictable result of monitoring and filtering the signals.
Regarding claim 31. (New) Libbus discloses the system of claim 24, but fails to disclose wherein the computer-readable instructions, when executed by the processor, cause the processor to perform one or more further operations comprising: receiving a skin sympathetic or parasympathetic activity; and calculating the pacing rate further based on the skin sympathetic or parasympathetic activity, wherein the skin sympathetic or parasympathetic activity is received from at least one of a high-pass or a band-pass filter.
Chen, from a similar field of endeavor teaches the electrical activity in the nerves that innervate the skin occurs at higher frequencies and lower amplitudes compared to the electrical signals generated in the cardiac muscle during a heartbeat. As such, processor 116 may be configured to identify and monitor the electrical signals corresponding to specific signals in the subject, such as nerve or cardiac activity, by processing data samples received from the signal detector 104. That is, the processor 116 may apply appropriate filters, such as low-pass filters, high-pass filters (para 0050-0057). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Libbus with the teachings of Chen to provide the predictable result of monitoring and filtering the signals.
Claim(s) 29, 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Libbus as applied to claims above, and further in view of US Pat Pub No. 20180235537 granted to Whiting et al. (hereinafter “Whiting”).
Regarding claim 29. (New) The system of claim 24, but fails to disclose wherein the calculating the pacing rate comprises: comparing the physiological input value to a target physiological input value; and determining the pacing rate based on comparing the physiological input value to the target physiological input value, and wherein the target physiological input value is based on one or more of a patient state, a patent demographic, a patient medication, an ambient condition, or a patient symptom.
Whiting, from a similar field of endeavor teaches that it is known to use a machine learning tool based upon historical data (including age, demographic, etc.) and models to perform computational and assisting in performing various determinations (para 0119, 0133). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Libbus as modified by Libbus ‘864 with the known machine learning tools of Whiting to provide the predictable result of performing computational and performing determinations.
Regarding claim 33. (New) Libbus discloses the system of claim 24, wherein the computer-readable instructions, when executed by the processor, cause the processor to perform one or more further operations comprising: receiving autonomic nervous system (ANS) activity from one of a direct sensor or an indirect function; and calculating the pacing rate further based on the ANS activity, but fails to disclose wherein one or both of the supra-threshold stimulus protocol or the sub-threshold stimulus protocol are output by an artificial intelligence (AI) model.
Whiting, from a similar field of endeavor teaches that it is known to use a machine learning tool based upon historical data and models to perform computational and assisting in performing various determinations (para 0119, 0133). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Libbus with the known machine learning tools of Whiting to provide the predictable result of performing computational and performing determinations.
Regarding claim 34. (New) Libbus discloses the system of claim 24, wherein the computer-readable instructions, when executed by the processor, cause the processor to perform one or more further operations comprising: receiving autonomic nervous system (ANS) activity from one or more of a direct sensor or an indirect function; and calculating the pacing rate further based on the ANS activity, wherein one or both of the supra-threshold stimulus protocol or the sub-threshold stimulus protocol are output by an artificial intelligence (AI) model, wherein the AI model is trained to output a stimulus protocol based on training data comprising the physiological input value and one or more of ANS activity, a patient age, a patient sex, a patient medication, an ambient temperature, or a patient symptom.
Whiting, from a similar field of endeavor teaches that it is known to use a machine learning tool based upon historical data and models to perform computational and assisting in performing various determinations (para 0119, 0133). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Libbus with the known machine learning tools of Whiting to provide the predictable result of performing computational and performing determinations.
Allowable Subject Matter
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: Claim 35 recites “receiving one of an indication that a paced cardiac beat is required or that a paced cardiac beat is not required; determining, based on receiving the indication that the paced cardiac beat is required, a supra-threshold stimulus protocol to produce cardiac pacing and stimulation of one or both of local sympathetic tissue or parasympathetic tissues to modify the physiological input value, based on the pacing rate; determining for the supra-threshold stimulus protocol, a first composite amplitude of pacing stimulus, a first frequency of sub-pulses, a first duration of sub-pulses, and a first refractory period between a current pacing stimulus and a subsequent pacing stimulus; determining, based on receiving the indication that the paced cardiac beat is not required, a sub-threshold stimulus protocol to produce feedback inhibition of a portion of an autonomic nervous system to modify the physiological input value based on the pacing rate; determining, for the sub-threshold stimulus protocol, a second composite amplitude of pacing stimulus, a second frequency of sub-pulses, a second duration of sub-pulses, and a second refractory period between a current pacing stimulus and a subsequent pacing stimulus”. The references discovered to not disclose, teach or render obvious the limitation above when taken as a whole with the remaining limitation of the claim. Claim 35 includes allowable subject matter which dependent claims 36-38 inherit.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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