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 § 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)(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.
Claim(s) 19-20, 22-25 & 27-35 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kowalski et al. (US 2015/0057563).
19.
A computer-implemented method for monitoring diaphragmatic response to phrenic nerve stimulation, comprising: receiving in real-time a diaphragmatic compound motor action potential (CMAP) signal of a human patient;
E.G. via the disclosed method for monitoring patient phrenic nerve function in response to stimulation and recording CMAP signals using a plurality of assessment electrodes 24 {[0010], [0030] & (Fig 3)}.
computing a baseline value of a characteristic of the CMAP signal, the characteristic representing a diaphragmatic response intensity to phrenic nerve stimulation;
E.G. via the disclosed processing device including an algorithm for determining a baseline amplitude value {[0037] & (Fig 11)}.
determining a threshold value of the characteristic, the threshold value representing a boundary of values of the characteristic indicative of upcoming diaphragmatic palsy, the determining of the threshold value including shifting the baseline value;
E.G. via the disclosed baseline amplitude used to by the processing device to produce a threshold percentage of CMAP amplitude which may be used to determine if the patient is susceptible to phrenic nerve palsy [0037].
repeating in real-time: monitoring the CMAP signal; computing a real-time value of the characteristic, the real-time value of the characteristic being asynchronous to a QRS complex of the human patient; comparing the real-time value to the threshold value; and outputting an alert when the threshold is passed.
E.G. via the disclosed processing device to monitor the CMAP signal slope and/or amplitude as compared to the preset threshold in order to identify the change in phrenic nerve function of the CMAP signal received once the amplitude may shift and/or ‘decline’ in order to generate an alert or alarm signal, wherein said processing device goes through a loop to repeat the detection sequence {[0037]-[0039] & (Fig 12)}.
20.
The method of claim 19, wherein the method comprises discarding diaphragmatic responses synchronous to QRS complexes.
E.G. via the disclosed processing device 26 further comprising an ECG acquisition circuitry which is used by the microcontroller may assess whether CMAP baseline is too low relative to a running average [0041].
21.
The method of claim 19, wherein the method further comprises commanding phrenic nerve stimulation, the method comprising triggering an occurrence of the phrenic nerve stimulation a predetermined amount of time after detection of an occurrence of the QRS complex such that diaphragmatic response to the triggered occurrence of the phrenic nerve stimulation occurs and ends before a next occurrence of the QRS complex.
22.
The method of claim 19, wherein the real-time value of the characteristic is an average of the characteristic for several occurrences of the phrenic nerve stimulation.
E.G. via the disclosed processing device being programmable to average the diaphragmatic CMAP signals based on a running average of CMAP signal amplitudes ([0008]-[0009] & [0041]).
23.
The method of claim 22, wherein the real-time value of the characteristic is an average of the characteristic for a predetermined number of consecutive occurrences of the phrenic nerve stimulation.
E.G. ([0008]-[0009] & [0041]).
24.
The method of claim 23, wherein the predetermined number is below or equal to 5.
E.G. ([0008]-[0009] & [0041]).
25.
The method of claim 19, wherein the computing of the real-time value of the characteristic comprises calculating one or more CMAP measures performed each on a portion of the CMAP signal beginning at a predetermined amount of time after an occurrence of the phrenic nerve stimulation and lasting for a predetermined time duration after the occurrence of the phrenic nerve stimulation.
E.G. via the disclosed time value for the diaphragmatic CMAP signals amplitudes and the predetermined threshold, wherein the detection window in which the CMAP signals is monitored ([0010] & [0036])
26. (New) The method of claim 25, wherein: the predetermined amount of time is larger than 3ms and/or lower than 50ms; and/or the predetermined time duration is larger than 50ms and/or lower than 150ms.
27.
The method of claim 19, wherein: the characteristic is: an amplitude difference between two consecutives peaks of the CMAP signal; or an area between an isoelectric line and a portion of a curve representing two consecutive peaks of the CMAP signal; and/or the threshold value corresponds to a drop of the baseline value which is larger than 25% and/or lower than 35%; and/or the CMAP signal is received from one or more surface electrodes and/or one or more intravascular electrodes.
E.G. [0036].
28.
The method of claim 19, wherein the repeating in real-time of the monitoring of the CMAP signal, of the computing of the real-time value of the characteristic which is asynchronous to the QRS complex, of the comparing of the real-time value to the threshold value, and of the outputting of the alert when the threshold is passed, is performed as the phrenic nerve stimulation is stable.
E.G. ([0036]-[0038]).
29.
The method of claim 19, wherein the phrenic nerve stimulation comprises a series of electrical pulses delivered to the patient, the phrenic nerve receiving, at each respective pulse during a period of time, a respective electrical energy that results from the pulse, the respective electrical energy received by the phrenic nerve for the respective pulse being equal to or larger than an electrical energy threshold, the electrical energy threshold being equal to or larger than a minimal electrical energy that is sufficient to cause a diaphragmatic response to phrenic nerve stimulation of the patient at rest.
E.G. [0010].
30.
The method of claim 29, wherein the electrical energy threshold is equal to or larger than an electrical energy value that corresponds to a supramaximal stimulation energy.
E.G. [0030].
31.
A non-transitory computer-readable data storage medium having recorded thereon a computer program comprising instructions for performing a computer-implemented method for monitoring diaphragmatic response to phrenic nerve stimulation, comprising: receiving in real-time a diaphragmatic compound motor action potential (CMAP) signal of a human patient;
E.G. via the disclosed method for monitoring patient phrenic nerve function in response to stimulation and recording CMAP signals using a plurality of assessment electrodes 24 {[0010], [0030] & (Fig 3)}.
computing a baseline value of a characteristic of the CMAP signal, the characteristic representing a diaphragmatic response intensity to phrenic nerve stimulation;
E.G. via the disclosed processing device including an algorithm for determining a baseline amplitude value {[0037] & (Fig 11)}.
determining a threshold value of the characteristic, the threshold value representing a boundary of values of the characteristic indicative of upcoming diaphragmatic palsy, the determining of the threshold value including shifting the baseline value;
E.G. via the disclosed baseline amplitude used to by the processing device to produce a threshold percentage of CMAP amplitude which may be used to determine if the patient is susceptible to phrenic nerve palsy [0037].
repeating in real-time: monitoring the CMAP signal; computing a real-time value of the characteristic, the real-time value of the characteristic being asynchronous to a QRS complex of the human patient; comparing the real-time value to the threshold value; and outputting an alert when the threshold is passed of claim 13.
E.G. via the disclosed processing device to monitor the CMAP signal slope and/or amplitude as compared to the preset threshold in order to identify the change in phrenic nerve function of the CMAP signal received once the amplitude may shift and/or ‘decline’ in order to generate an alert or alarm signal, wherein said processing device goes through a loop to repeat the detection sequence {[0037]-[0039] & (Fig 12)}.
32.
A device including a control unit comprising a processor coupled to a memory, the memory having recorded thereon a computer-implemented method for monitoring diaphragmatic response to phrenic nerve stimulation, comprising: receiving in real-time a diaphragmatic compound motor action potential (CMAP) signal of a human patient;
E.G. via the disclosed method for monitoring patient phrenic nerve function in response to stimulation and recording CMAP signals using a plurality of assessment electrodes 24 {[0010], [0030] & (Fig 3)}.
computing a baseline value of a characteristic of the CMAP signal, the characteristic representing a diaphragmatic response intensity to phrenic nerve stimulation; determining a threshold value of the characteristic, the threshold value representing a boundary of values of the characteristic indicative of upcoming diaphragmatic palsy, the determining of the threshold value including shifting the baseline value;
E.G. via the disclosed processing device including an algorithm for determining a baseline amplitude value {[0037] & (Fig 11)}.
repeating in real-time: monitoring the CMAP signal; computing a real-time value of the characteristic, the real-time value of the characteristic being asynchronous to a QRS complex of the human patient; comparing the real-time value to the threshold value; and outputting an alert when the threshold is passed.
E.G. via the disclosed processing device to monitor the CMAP signal slope and/or amplitude as compared to the preset threshold in order to identify the change in phrenic nerve function of the CMAP signal received once the amplitude may shift and/or ‘decline’ in order to generate an alert or alarm signal, wherein said processing device goes through a loop to repeat the detection sequence {[0037]-[0039] & (Fig 12)}.
33.
The device of claim 32, further comprising: a plurality of electrodes configured to measure the CMAP signal, a phrenic nerve stimulation system, and a cryoablation catheter.
E.G. [0030].
34.
The device of claim 33, wherein the plurality of electrodes comprises one or more surface electrodes and/or one or more intravascular electrodes.
E.G. [0028].
35.
The device of claim 33, wherein the system further comprises: a display for outputting a visual alert when the threshold is passed; and/or a sound emitting device for outputting a sound alert when the threshold is passed.
E.G. via the disclosed display 54 [0030].
Allowable Subject Matter
Claim 21 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.
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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796