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 .
Response to Arguments
Applicant’s amendments overcome the objections to the claims, and therefore they are withdrawn. Applicant’s amendments further merit new grounds of rejection under 35 U.S.C. § 103 in view of Tehrani et al. (U.S. Patent Application Publication No. 2011/0288609) hereinafter referred to as Tehrani; in view of Christopherson et al. (U.S. Patent Application No. 2024/0197200 with internal incorporation by reference to U.S. Patent Application Publication No. 2011/0264164) hereinafter respectively referred to as Christopherson ‘200 and Christopherson ‘164. Claims 17-20 merit new grounds for rejection in view of Meyyappan et a. (U.S. Patent Application Publication No. 2022/0023625) hereinafter referred to as Meyyappan.
Applicant's arguments filed 8/7/2026 have been fully considered but they are not persuasive. With respect to claims 17-20, Applicant argues that Mahony alone does not anticipate the amended claims. The Examiner does not dispute this argument, but the new grounds for rejection below with citations to Meyyappan, and subsequently, Tehrani and Christopherson ‘200 render the arguments unpersuasive.
Similarly, with respect to the remaining claims, Applicant’s arguments are directed to whether the previous rejection teaches the amended portions of the instant claims. These arguments are unpersuasive in light of the new grounds for rejection, below.
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) 1-4, 8-14, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Mahony (U.S. Patent Application Publication No. 2019/0134394) hereinafter referred to as Mahony; in view of Tehrani et al. (U.S. Patent Application Publication No. 2011/0288609) hereinafter referred to as Tehrani; in view of Christopherson et al. (U.S. Patent Application No. 2024/0197200 with internal incorporation by reference to U.S. Patent Application Publication No. 2011/0264164) hereinafter respectively referred to as Christopherson ‘200 and Christopherson ‘164.
Regarding claim 1, Mahony teaches a phrenic nerve stimulation (¶[0002]) system, comprising:
a phrenic nerve stimulation control console configured to control a stimulation intensity of a phrenic nerve stimulation signal deliverable to at least one phrenic nerve (¶[0048] PEPNS system, Fig. 1a, operating console) during mechanical ventilation (¶[0049] mechanical ventilator element 108); and
a phrenic nerve stimulation lead assembly (element 16 lead system, ¶[0049], Fig. 1a) including at least one electrode lead (Fig. 2, electrode lead 200) positionable proximate to the at least one phrenic nerve to output the phrenic nerve stimulation signal from the phrenic nerve stimulation control console to the corresponding phrenic nerve (¶[0049]),
wherein, in response to a detected level of patient respiratory effort being outside a predetermined range (¶[0104] work of breathing WOB reflects respiratory effort, when the average WOB is below a desired WOB level, it is outside a predetermined range, ¶[0026] and Fig. 7) during a first stimulated breath (any single breath may be considered a first breath), to adjust the stimulation intensity (¶[0096], ¶[0104]).
Mahony does not teach the phrenic nerve stimulation control console automatically and controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal by a preset increment value for a second stimulated breath after the first stimulated breath, wherein the preset increment value is independent of the detected level of patient respiratory effort.
Attention is brought to the Tehrani reference, which teaches a phrenic nerve stimulation (¶[0128]) control console (¶[0269]) controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal (¶[0293] automatically adjusted by the device) for a second stimulated breath after the first stimulated breath (¶[0271]) coordinated with patient breaths and mechanical ventilation, e.g. only during exhalation or only during inhalation and therefore, breath to breath).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony to include breath-to-breath stimulation adjustment, as taught by Tehrani, because Tehrani teaches adjustability meets respiratory demands/needs of specific patients (Tehrani ¶[0288]).
Mahony as modified does not specifically teach wherein the preset increment value is independent of the detected level of patient respiratory effort.
Attention is brought to the Christopherson ‘200 reference, which teaches nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0076], ¶[0183]).
The internally referenced Christopherson ‘164 reference, more explicitly describing the following: nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0049] and ¶[0050] increment function, one or more steps, ¶[0143] specific percentage steps e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony as modified to automatically and controllable increment or decrement nerve stimulation, as taught in Christopherson ‘200 (and further described in internally incorporated Christopherson ‘164) because doing so maximizes efficacy while minimizing power consumption and patient annoyance and avoids unnecessary stimulation (Christopherson ‘164 ¶[0049-0050]).
Regarding claim 2, Mahony as modified teaches the system of claim 1.
Mahony teaches further comprising a breath sensor (¶¶[0048-0049] wye sensor element 102/106) in communication with the phrenic nerve stimulation control console (¶[0048] PEPNS system in communication with instrumented wye sensor, Fig. 1a) and being configured to couple with an air flow path of a breathing circuit during mechanical ventilation (¶¶[0048-0049] wye sensor element 102/106, Fig. 1a), wherein a sensor information from the breath sensor is received at the phrenic nerve stimulation control console so that the phrenic nerve stimulation control console identifies the detected level of patient respiratory effort (Fig. 1a, output from element 106 is input as WOB “work of breathing” into control console).
Regarding claim 3, Mahony as modified teaches the system of claim 1.
Mahony further teaches detecting a level of patient respiratory effort being lower than the predetermined range (¶[0104] work of breathing WOB reflects respiratory effort, when the average WOB is below a desired WOB level, it is outside a predetermined range, ¶[0026] and Fig. 7) to adjust the stimulation intensity (¶[0096], ¶[0104]).
Mahony does not teach wherein the phrenic nerve stimulation control console controllably increments the stimulation intensity of the phrenic nerve stimulation signal by the preset increment value in response to the detected level of patient respiratory effort being lower than the predetermined range.
Attention is brought to the Tehrani reference, which teaches a phrenic nerve stimulation control console (Abstract) controllably increments the stimulation intensity of the phrenic nerve stimulation signal in response to the detected level of patient respiratory effort being lower than the predetermined range (¶[0293])
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony to include breath-to-breath stimulation adjustment, as taught by Tehrani, because Tehrani teaches adjustability meets respiratory demands/needs of specific patients (Tehrani ¶[0288]).
Mahony as modified does not specifically teach wherein the preset increment value is independent of the detected level of patient respiratory effort.
Attention is brought to the Christopherson ‘200 reference, which teaches nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0076], ¶[0183]).
The internally referenced Christopherson ‘164 reference, more explicitly describing the following: nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0049] and ¶[0050] increment function, one or more steps, ¶[0143] specific percentage steps e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony as modified to automatically and controllable increment or decrement nerve stimulation, as taught in Christopherson ‘200 (and further described in internally incorporated Christopherson ‘164) because doing so maximizes efficacy while minimizing power consumption and patient annoyance and avoids unnecessary stimulation (Christopherson ‘164 ¶[0049-0050]).
Regarding claim 4, Mahony as modified teaches the system of claim 3.
Mahony further teaches detecting a level of patient respiratory effort being higher than the predetermined range (¶[0104] work of breathing WOB reflects respiratory effort, when the average WOB is above a desired WOB level, it is outside a predetermined range, ¶[0026] and Fig. 7) to adjust the stimulation intensity (¶[0096], ¶[0104], Fig. 7).
Mahony does not teach wherein the phrenic nerve stimulation control console controllably decrements the stimulation intensity of the phrenic nerve stimulation signal by the preset increment value.
Attention is brought to the Tehrani reference, which teaches a phrenic nerve stimulation control console (Abstract) controllably decrements the stimulation intensity of the phrenic nerve stimulation signal in response to the detected level of patient respiratory effort being higher than the predetermined range (¶[0293])
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony to include breath-to-breath stimulation adjustment, as taught by Tehrani, because Tehrani teaches adjustability meets respiratory demands/needs of specific patients (Tehrani ¶[0288]).
Mahony as modified does not specifically teach wherein the preset increment value is independent of the detected level of patient respiratory effort.
Attention is brought to the Christopherson ‘200 reference, which teaches nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0076], ¶[0183]).
The internally referenced Christopherson ‘164 reference, more explicitly describing the following: nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0049] and ¶[0050] increment function, one or more steps, ¶[0143] specific percentage steps e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony as modified to automatically and controllable increment or decrement nerve stimulation, as taught in Christopherson ‘200 (and further described in internally incorporated Christopherson ‘164) because doing so maximizes efficacy while minimizing power consumption and patient annoyance and avoids unnecessary stimulation (Christopherson ‘164 ¶[0049-0050]).
Regarding claim 8, Mahony as modified teaches the system of claim 1.
Mahony further teaches wherein the phrenic nerve stimulation control console is integrated into a console of a mechanical ventilator such that a cable of the phrenic nerve stimulation lead assembly mates with the mechanical ventilator (Fig. 1a, mechanical ventilator “MECH VENT” connected to console via at least connection represented by callout element 113, ¶[0050]).
Regarding claim 9, Mahony as modified teaches the system of claim 1.
Moahony further teaches, wherein the at least one electrode lead of the phrenic nerve stimulation lead assembly comprises a first electrode lead and a second electrode lead (¶[0054]), and each of the first and second electrode leads comprises one of: multiple segmented electrodes along a cylindrical portion of a percutaneously insertable lead tip (Fig. 2, ¶[0049]).
Regarding claims 10-14 and 16/20, the claims are directed to a system/method comprising substantially the same subject matter as claims 1-4/1 and 8 and are rejected under substantially the same sections of Mahony, Tehrani, and Christopherson ‘200.
Claim(s) 5-7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahony, Tehrani, and Christopherson ‘200 as applied to claim 1 above, and further in view of Gani et al. (U.S. Patent Application Publication No. 2020/0147364) hereinafter referred to as Gani.
Regarding claim 5/15, Mahony as modified teaches the system of claim 4/14.
Mahony further teaches a graphic user interface to receive user input of a selected value for stimulation parameters (Fig. 1b).
Mahony as modified does not teach a selected value for a preset increment value.
Attention is drawn to the Gani reference, which teaches a graphic user interface to receive user input of a selected value for a preset increment value (¶[0072], Fig. 4).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the graphical user interface of Mahony as modified to include increment values for titrating therapy, as taught by Gani, because Gani teaches a user interface for weaning from mechanical ventilation via input from a clinician (Gani, ¶[0003], ¶[0145])
Regarding claim 6, Mahony as modified teaches the system of claim 5.
Mahony further teaches wherein the graphic user interface of the phrenic nerve stimulation control console (Fig. 1b, user interface) is configured to receive a customized selection of an operating range for the stimulation of the phrenic nerve stimulation signal (Fig. 1b, stimulation parameters include pulse rate, pulse width and current, polarity, etc. the combination of which sets a range for stimulation intensity).
Mahony does not teach a specified intensity of stimulation.
Attention is brought to the Gani reference, which teaches user input specifying an intensity range for stimulation (¶[0072], Fig. 4).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the graphical user interface of Mahony as modified to include increment values for titrating therapy, as taught by Gani, because Gani teaches a user interface for weaning from mechanical ventilation via input from a clinician (Gani, ¶[0003], ¶[0145])
Regarding claim 7, Mahony as modified teaches the system of claim 1.
Mahony does not teach wherein the phrenic nerve stimulation control console is configured to automatically identify a maximum level of stimulation intensity of an operating range for the stimulation intensity of the phrenic nerve stimulation signal, wherein the phrenic nerve stimulation control console controllably increments or decrements the stimulation intensity by the preset increment value so that the stimulation intensity remains within the operating range.
Attention is brought to the Gani reference, which teaches wherein the phrenic nerve stimulation control console is configured to automatically identify a maximum level of stimulation intensity of an operating range for the stimulation intensity of the phrenic nerve stimulation signal (¶[0145]), wherein the phrenic nerve stimulation control console controllably increments or decrements the stimulation intensity by the preset increment value so that the stimulation intensity remains within the operating range (¶¶[0076-0077]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the graphical user interface of Mahony as modified to include increment values for titrating therapy, as taught by Gani, because Gani teaches a user interface for weaning from mechanical ventilation via input from a clinician (Gani, ¶[0003], ¶[0145])
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Mahony (U.S. Patent Application Publication No. 2019/0134394) hereinafter referred to as Mahony; in view of Meyyappan et a. (U.S. Patent Application Publication No. 2022/0023625) hereinafter referred to as Meyyappan.
Regarding claim 17, Mahony teaches a method of controlling phrenic nerve stimulation (Abstract), comprising:
after delivering a first cycle of phrenic nerve stimulation at a first intensity level (¶[0052], Fig. 1b) from a phrenic nerve stimulation apparatus to at least one stimulation lead proximate to at least one phrenic nerve (¶[049]),
delivering a second cycle of phrenic nerve stimulation at the first intensity level (¶[0052], Fig. 1b) from the phrenic nerve stimulation apparatus to the at least one stimulation lead proximate to the at least one phrenic nerve (¶[0049]);
comparing a parameter indicative of diaphragm contractile force detected during the first cycle to the parameter detected during the second cycle; and
in response to determining that the parameter indicative of diaphragm contractile force is greater during the second cycle than the first cycle (Fig. 7, ¶[0026], ¶[0091]), outputting an alert via a user interface of the phrenic nerve stimulation apparatus indicative of a readiness to wean from mechanical ventilation (¶[0091]).
Mahony does not teach comparing a parameter indicative of diaphragm contractile force detected during the first cycle to the parameter detected during the second cycle for determining increasing WOB and readiness to wean.
Attention is drawn to the Meyyappan reference, which teaches comparing a parameter indicative of diaphragm contractile force detected during the first cycle to the parameter detected during the second cycle for determining increasing WOB and readiness to wean (¶¶[0172-0173] complete picture of diaphragm strength over time to predict readiness to wean, ¶¶[0051-0052]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the weaning of Mahony to incorporate user specific diaphragm contractile force changes, as taught by Meyyapan because it enables the clinician to assess the true status of the diaphragm in the absence of confounding factors usually associated with voluntary breathing maneuvers (Meyyappan ¶[0173]) and successfully weaning patients earlier than other known methods (Meyyappan ¶[0013], ¶[0109]).
Regarding claim 18, Mahony as modified teaches the method of claim 17.
Mahony further teaches, wherein the phrenic nerve stimulation apparatus includes: a phrenic nerve stimulation control console configured to control a stimulation intensity of a phrenic nerve stimulation signal deliverable to at least one phrenic nerve (¶[0048] PEPNS system, Fig. 1a, operating console) during mechanical ventilation (¶[0049] mechanical ventilator element 108); and
a phrenic nerve stimulation lead assembly (element 16 lead system, ¶[0049], Fig. 1a) including at least one electrode lead (Fig. 2, electrode lead 200) positionable proximate to the at least one phrenic nerve to output the phrenic nerve stimulation signal from the phrenic nerve stimulation control console to the corresponding phrenic nerve (¶[0049]).
Regarding claim 19, Mahony as modified teaches the method of claim 18.
Mahony teaches further comprising receiving breath sensor information from a breath sensor (¶¶[0048-0049] wye sensor element 102/106) in communication with the phrenic nerve stimulation control console (¶[0048] PEPNS system in communication with instrumented wye sensor, Fig. 1a) and being coupled with an air flow path of a breathing circuit during mechanical ventilation (¶¶[0048-0049] wye sensor element 102/106, Fig. 1a),and identifying a detected level of patient respiratory effort based upon the breath sensor information (Fig. 1a, output from element 106 is input as WOB “work of breathing” into control console).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahony and Meyyappan as applied to claim 17 above, and further in view of Tehrani et al. (U.S. Patent Application Publication No. 2011/0288609) hereinafter referred to as Tehrani; in view of Christopherson et al. (U.S. Patent Application No. 2024/0197200 with internal incorporation by reference to U.S. Patent Application Publication No. 2011/0264164) hereinafter respectively referred to as Christopherson ‘200 and Christopherson ‘164.
Regarding claim 20, Mahony as modified teaches the method of claim 19.
Mahony further teaches wherein, in response to a detected level of patient respiratory effort being outside a predetermined range (¶[0104] work of breathing WOB reflects respiratory effort, when the average WOB is below a desired WOB level, it is outside a predetermined range, ¶[0026] and Fig. 7) during a first stimulated breath (any single breath may be considered a first breath), to adjust the stimulation intensity (¶[0096], ¶[0104]).
Mahony does not teach the phrenic nerve stimulation control console automatically and controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal by a preset increment value for a second stimulated breath after the first stimulated breath, wherein the preset increment value is independent of the detected level of patient respiratory effort.
Attention is brought to the Tehrani reference, which teaches a phrenic nerve stimulation (¶[0128]) control console (¶[0269]) controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal (¶[0293] automatically adjusted by the device) for a second stimulated breath after the first stimulated breath (¶[0271]) coordinated with patient breaths and mechanical ventilation, e.g. only during exhalation or only during inhalation and therefore, breath to breath).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony to include breath-to-breath stimulation adjustment, as taught by Tehrani, because Tehrani teaches adjustability meets respiratory demands/needs of specific patients (Tehrani ¶[0288]).
Mahony as modified does not specifically teach wherein the preset increment value is independent of the detected level of patient respiratory effort.
Attention is brought to the Christopherson ‘200 reference, which teaches nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the phrenic nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0076], ¶[0183]).
The internally referenced Christopherson ‘164 reference, more explicitly describing the following: nerve stimulation control console for breathing controllably increments or decrements the stimulation intensity of the nerve stimulation signal by a preset increment value wherein the preset increment value is independent of the detected level of patient respiratory effort (¶[0049] and ¶[0050] increment function, one or more steps, ¶[0143] specific percentage steps e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Mahony as modified to automatically and controllable increment or decrement nerve stimulation, as taught in Christopherson ‘200 (and further described in internally incorporated Christopherson ‘164) because doing so maximizes efficacy while minimizing power consumption and patient annoyance and avoids unnecessary stimulation (Christopherson ‘164 ¶[0049-0050]).
Conclusion
The prior art made of record and not relied upon remains pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2019/0175908 to Thakkar et al. teaches titrating respiratory therapy muscle stimulation for weaning from mechanical ventilation.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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