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 .
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.
Claim 1 is 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 limitation “deliver a stimulation…at a beginning of the inspiratory respiratory phases” is unclear because “a beginning” is singular while “phrases” is plural. Accordingly, it is unclear whether stimulation is delivered at the beginning of each detected inspiratory respiratory phase, at the beginning of only phase, or at some other time associated with the phases.
And,
The term “optimal sensing electrode” and “optimal stimulation electrodes” in claim 1 are relative terms which renders the claim indefinite. The terms 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 claim and specification do not identify the measured parameter, comparison criterion, or threshold used to designate an electrode an “optimal.”
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.
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) 2-7, 9, 15, 26, 34-40, 42 & 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papay et al. (US 2020/0016401) in view of Suri et al. (US 2018/0221660).
Claim 1.
Papay et al. teaches a system for treating obstructive sleep apnea comprising
An array of multiple electrodes:
E.G. via the disclosed neuromuscular stimulation system having multiple electrodes, including an electrode array configured to stimulate arborizing hypoglossal branches associated with the anterior lingual musculature ([0051], [0076]).
Memory and a processor configured to execute instructions:
E.G. via the disclosed controller that receives and processes sensor information, stores stimulation programs, and controls delivery of therapy signals ([0005]-[0007])
Receiving EMG signals from electrodes located in the floor-of-mouth region:
E.G. via the disclosed intraoral or submental implantation of electrodes in electrical communication with the sublingual/anterior lingual musculature, including the genioglossus ([0065]-[0070]).
Measuring genioglossus activity:
E.G. via the disclosed EMG sensor records electrical activity of the genioglossus, which serves as a respiratory biomarker ([0080]-[0081]).
Determining inspiratory and expiratory respiratory phases:
E.G. via the disclosed genioglossus EMG activity that is monitored to identify periods of the respiratory cycle and trigger stimulation during the appropriate phase [0080].
Delivering stimulation in response to the detected inspiratory phase:
E.G. via a stimulating electrode delivers a therapy signal to the genioglossus muscle or associated nerve in response to the respiratory EMG signal ([0080]-[0081]).
Closed-loop confirmation:
E.G. via the disclosed sensing component detects physiological activity associated with treatment efficacy and adjusts stimulation in response to the detected feedback ([0007], [0076], [0080]-[0081]).
Papay et al. does not expressly teach filtering the EMG signals to generate an envelope, selecting optimal sensing electrodes from the envelope, or sequentially pulsing the electrodes to determine optimal stimulation electrodes.
Suri et al. teaches:
Sequentially pulsing the available electrodes:
E.G. via the disclosed sequential delivery of electrical pulse train to each electrode contact or set of contacts ([0041]-[0042]),
Measuring the resulting physiological response:
E.G. via the disclosed EMG sensors measuring muscle-cell electrical potentials, and tongue-movement sensors to determine the physiological effect of stimulation ([0021], [0034]).
Scoring electrodes based on the measured response:
E.G. via the disclosed programmer that computes an electrode score using the measured physiological parameter ([0021], [0035])
Selecting optimal stimulation electrodes:
E.G. via the disclosed control circuitry selects the electrode contacts that optimally activate HGN fascicles innervating the genioglossus while avoiding recruitment of tongue retractor muscle [0093].
Delivering hypoglossal-nerve stimulation at inspiration:
E.G. via the disclosed stimulation that is synchronized with the onset of the inspiratory phase ([0083]-[0084] & [0094]-[0095]).
It would have been obvious to one having ordinary skill in the art to modify Papay’s multiple-electrode, EMG-feedback system according to Suri et al. by sequentially stimulating the available electrodes, measuring the resulting genioglossus response with Papay’s EMG-sensing electrodes, and selecting the electrode configuration producing the desired response. The modification would provide patient-specific stimulation, preferentially recruit tongue-protrusor musculature, avoid tongue-retractor recruitment, and improve airway-opening efficacy ([0041]-[0042], [0093]).
It would further have been obvious to filter or rectify Papay’s EMG signals to obtain a signal envelope representing genioglossus activity and to select the sensing electrodes providing the strongest or most reliable muscle-activity signal. Such signal conditioning and channel selection represent predictable processing of Papay’s multichannel physiological signals for reliably detecting respiratory activity and measuring stimulation response.
Claim 2.
Papay in view of Suri teaches the system of claim 1 and further teaches:
Measuring a physiological response indicative of the efficacy of the delivered stimulation parameters based on sensor feedback ([0007], [0076], [0080]-[0081]; Suri [0021], [0034]-[0035]); and
Stimulation amplitude as an adjustable stimulation parameter (Papay, [0016], [0052], [0074]; Suri, [0026], [0043], [0119]).
It would have been obvious to adjust stimulation amplitude based on the measured response to provide sufficient muscle recruitment while avoiding unnecessary or excessive stimulation.
Claim 3.
Papay in view of Suri teaches:
Stimulation signals having selectable polarity and electrodes capable of positive current, negative current, stopping current, and changing current direction ([0016], [0031], [0052]); and
Selecting individual contacts or contact pairs for monopolar and bipolar stimulation (Suri, [0042], [0119], 0128]).
Accordingly, adjusting an electrode’s polarity or removing the electrode from the active configuration would have been an obvious selection among disclosed electrode-operating modes.
Claim 4.
Suri teaches:
Sequentially stimulating each electrode contact or contact set;
Measuring the resulting physiological response; and
Identifying the contact configuration providing the best treatment response ([0042], [0044]-[0046], [0128]-[0129]).
Under BRI, the sequential test-stimulation procedures constitute “maneuvers” that activate the genioglossus and permit identification of the electrodes producing the best response.
Claim 5.
Papay and Suri teach:
Continuous monitoring of genioglossus EMG activity in a closed-loop system (Papay, [0076], [0080]-[0081]).
Using the same or associated electrodes for sensing and stimulation (Papay, [0061]-[0064], [0080]-[0081]); and
Measuring EMG or tongue-movement feedback to confirm the efficacy of the delivered stimulation (Suri, [0021], [0034]-[0035], [0044]-[0046]).
It would have been obvious to continually monitor the EMG response from the selected sensing electrodes to confirm continued activation of the genioglossus by the selected stimulation electrodes.
Claim 6.
Suri teaches:
Testing different individual contacts and electrode-contract pairs;
Determining the optimal contact set; and
Programming the stimulator to use the selected optimal set ([0042], [0128]-[0129]).
Papay further teaches adaptive stimulation programs responsive to physiological inputs. It would not have been obvious to repeat Suri’s titration process and update the optimal stimulation pair when another tested pair produces a superior response.
Claim 7.
Papay et al. teaches:
Multiple sensing electrodes or leads;
Physiological feedback obtained from the sensing components; and
Adaptive programs responsive to sensor input ([0061]-[0064], [0076], [0080]-[0081]).
Claim 9.
Papay teaches:
Adjustable stimulation amplitude and frequency; and
Manual adjustment of treatment parameters by the subject or physician ([0016], [0035], [0052], [0074]).
Suri et al. teaches a patient programmer for controlling the stimulation system ([0020], [0129]). It would have been obvious to permit the patient to adjust stimulation frequency based on perceived sensation to obtain an effective but tolerable stimulation setting.
Claim 15.
Papay et al. expressly teaches:
Detecting an increase in genioglossus EMG activity indicating imminent inspiration; and
Delivering stimulation before the onset of inspiration ([0080], [0083]-[0084]).
Suri likewise teaches predicting inspiratory onset and delivering stimulation immediately before, at, or slightly after the predicted onset ([0083]-[0084], [0094]-[0095]).
Claim 26.
Suri teaches a feedback system comprising one or more temperature sensors that measure inhaled and exhaled air as an indication of respiration ([0021], [0034], [0036])
Under BRI, the phrase “a temperature sensor and/or SpO2 sensor” encompasses a system having a temperature sensor alone. Thus, Suri satisfies the limitation.
Claim 34.
Papay and Suri teach performing the method corresponding to the functions mapped for claim 1:
Providing a multiple-electrode system (Papay, [0051], [0064], [0076]).
Receiving genioglossus EMG signals from sublingual electrodes (Papay, [0065]-[0070], [0080]-[0081]).
Filtering the EMG signals (Papay, [0082]-[0083]).
Determining respiratory phases from the processed EMG signals (Papay, [0080], [0082]-[0084])
Sequentially testing electrode contacts and measuring the physiological response (Sur, [0042], [0044]-[0046], [0128]).
Selecting optimal stimulation contacts and measuring the physiological response (Suri, [0093], [0128]-[0129]);
Delivering hypoglossal stimulation at inspiratory onset (Suri, [0083]-[0084], [0094]-[0095]); and
Monitoring EMG or tongue movement to confirm stimulation efficacy (Papay, [0076], [0080]-[0081]; Suri, [0021], [0034]-[0035]).
The same rationale stated for claim 1 applies to performing these operations as a method.
Claim 35-40.
Claims 35-40 respectively recite the method counterparts of claims 2-7. Papay et al. and Suri render these limitations obvious for the reasons stated from claims 2-7, incorporated from above.
Claim 42.
Claim 42 recites the method counterpart of claim 9. Papay teaches adjustable stimulation amplitude and frequency and permits the patient or physician to modify treatment parameters ([0016], [0035], [0052], [0074]). Suri teaches patient-programmer control ([0020], [0129]).
Claim 48.
Claim 48 recites the method counterpart of claim 15. Papay teaches detecting an EMG change indicative of imminent inspiration and delivering stimulation before inspiratory onset ([0080], [0082]-[0084]). Suri likewise teaches predicting inspiration and stimulating immediately before, at or after its onset ([0083], [0084], [0094]-[0095]).
Claim(s) 11 & 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papay et al. (US 2020/0016401) in view of Suri et al. (US 2018/0221660) and further in view of Bolea (US 2016/0089540), as applied to claim 1 and 34.
Papay et al. and Suri et al. teach predicting the beginning of inspiration and timing stimulation accordingly. Bolea further teaches:
Storing historical respiratory-cycle timing information;
Determining a predicted interval for a current respiratory cycle;
Predicting the next stimulation onset from preceding cycle timing; and
Alternatively setting stimulation according to an average sleeping respiratory rate ([0128], [0316]-[0327]).
It would have been obvious to use previous-cycle timing and average respiratory rate to predict inspiratory onset because this permits stimulation timing when the contemporaneous respiratory signal is noisy or temporarily unavailable.
Allowable Subject Matter
Claims 8, 10, 12-14, 16-25, 27-33, 41, 43, 45-47 and 49-60 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 prior art of record, including Papay, Suri and Bolea, fails to teach or suggest the claimed safety-threshold control; M-wave/H-reflex analysis; sleep and apnea prediction based on the specifically claimed respiratory or integrated-EMG parameters; claimed control equations; submental acoustic and posture-sensing arrangements; stimulation-artifact transfer function; EMG-frequency-based fatigue detection; or integration of the system into the claimed intraoral appliances. These limitations, in combination with the respective base-claim limitations, distinguish the claims from the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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