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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 63/244939 filed on 09/16/2021.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1 -3 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 20190344034).
Regarding claim 1, Li discloses a method, performed by a ventilator, for automatic synchrony adjustment in medical ventilation (see [0023], [0032], [0079]), the method comprising: delivering positive pressure during a first inhalation phase (e.g. pressure support, see [0085]; see [0023]); cycling to a first exhalation phase at an end of the first inhalation phase according to a cycling sensitivity of the ventilator (see [0085], cycling to exhalation at default value); at an end of the first exhalation phase, triggering a second inhalation phase (see [0023], wherein the ventilator cycle is continuous, see also Figs. 1, 2, 7, illustrating multiple I/E phases); during at least one of the first exhalation phase or the second inhalation phase, detecting a cycling-related asynchrony event (cycling effort is determined within defined period of time before the end of the phase, see [0087], [0035]); in response to the detecting, automatically adjusting the cycling sensitivity without additional user input (see [0086], [0082]); delivering positive pressure during the second inhalation phase (see [0023], wherein the ventilator cycle is continuous, see also Figs. 1, 2, 7, illustrating multiple I/E phases); and cycling from the second inhalation phase to a second exhalation phase according to the adjusted cycling sensitivity (see [0087], [0035], [0081], wherein monitoring/adjustment is performed in the same phase for optimizing each breath).
2. The method of claim 1, wherein the cycling-related asynchrony event is detected during the first exhalation phase (e.g. premature cycling occurs in exhalation phase, see [0083]).
3. The method of claim 1, wherein the cycling-related asynchrony event is detected during the second inhalation phase (e.g. delayed cycling occurs in inhalation phase, see [0083]).
9. A method, performed by a ventilator, for automatic synchrony adjustment in medical ventilation (see [0023], [0032], [0079]), the method comprising: triggering a first inhalation phase according to a triggering sensitivity of the ventilator (see [0087]; note also [0085], providing general teaching of triggering to inhalation at default value); delivering positive pressure during the first inhalation phase (e.g. pressure support, see [0085]; see [0023]); cycling to a first exhalation phase at an end of the first inhalation phase (see [0087]; see also [0023]); during the first exhalation phase, detecting a missed-triggering event associated with the first inhalation phase (triggering effort is determined within defined period of time before the end of the phase, see [0087], [0035]); in response to detecting the missed-triggering event, automatically increasing the triggering sensitivity without additional user input (see [0086], [0082]); at an end of the first exhalation phase, triggering a second inhalation phase according to the increased triggering sensitivity (see [0087], [0035], [0081], wherein monitoring/adjustment is performed in the same phase for optimizing each breath); and delivering positive pressure during the second inhalation phase (see [0023], wherein the ventilator cycle is continuous, see also Figs. 1, 2, 7, illustrating multiple I/E phases).
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.
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) 4 - 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Angelico (US 20140034054).
Regarding claim 4, Li discloses the method of claim 1, wherein the cycling-related asynchrony event is one of a premature-cycling event or a double-triggering event (see [0083]), but does not explicitly disclose that adjusting the cycling sensitivity decreases the cycling sensitivity. Nonetheless, Angelico discloses that a double-triggering should decrease the cycling sensitivity (see table 1, p. 22, rows involving “double trigger” asynchrony). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the double-trigger adjustment of Li according to the decrease in sensitivity as discussed in Angelico for the benefit of ensuring the trigger is not so sensitive so as to initiate exhalation before the patient is actually exhaling.
Regarding claim 5, Li discloses the method of claim 1, wherein the cycling-related asynchrony event is a delayed-cycling event (see [0083]), but does not explicitly disclose that adjusting the cycling sensitivity increases the cycling sensitivity. Nonetheless, Angelico di8sclsoes that a delayed-cycling event should increase the cycling sensitivity (see table 1, p. 22, rows involving “late cycle” asynchrony”). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the delayed-cycling adjustment of Li according to the increase in sensitivity as discussed in Angelico for the benefit of ensuring the trigger is sensitive enough to initiate exhalation when the patient actually exhales.
Claim(s) 6 – 7, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Xu (US 20210154423).
Regarding claim 6, Li discloses the method of claim 1, and additionally discloses that signals used for distortion analysis for detection of patient effort events include net flow as well as derivatives thereof, see [0034], [0042 – 0043]. However, Li does not disclose that detecting the cycling-related asynchrony event comprises a slope of a net flow crossing zero during the first exhalation phase. Nonetheless, Xu discloses that detection of a cycling-related asynchrony event related to premature cycling comprises a slope of a net flow crossing zero during the first exhalation phase (see [0148-0149], wherein a change from increasing values to decreasing values involves the slope crossing zero; see also general teaching of using slope of the flow in [0102, 0110]; see Fig. 11, the inhalation phase is indicated by dashed lines, the exhalation phase by solid lines per [0145]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the cycling related asynchrony event discussed in Li according to the premature cycling analysis discussed in Xu for the benefit of appropriately identifying the asynchrony event according to the tell-tale waveform parameters, see [0050].
7. The method of claim 1, wherein detecting the cycling-related asynchrony event comprises at least one of a slope of a net flow exceeding a slope threshold during the first exhalation phase (see Xu, [0145], flow slope at an initial stage of the expiratory phase has the trend of comparative rising; alternatively, the threshold may be a lower threshold, i.e. zero, wherein negative values thus exceed the threshold), or a second slope of a net flow exceeding a slope threshold during the first exhalation phase (see general teaching of accelerated rise in [0107], which would have been an obvious parameter to detect based on the similarly shaped humps in Figs. 7 and 11; examiner lastly notes that claims 6 and 7 do not require the actual derivation of a first or second slope, but merely that the identified asynchronous waveform contain such qualities).
Regarding claim 13, Li discloses the method of claim 9, and additionally discloses that signals used for distortion analysis for detection of patient effort events include net flow as well as derivatives thereof, see [0034], [0042 – 0043]. However, Li does not disclose that the missed-triggering event is detected based on a local minimum and a local maximum of a slope of a net flow signal. Nonetheless, Xu discloses that detection of a cycling-related asynchrony event related to missed trigger is detected based on rises/drops in a slope of a net flow signal (Xu discloses detecting the accelerated rises and drop associated with missed triggering in [0102], [0107], or change in flow slope, which would characteristically include the local minimum/maximum of the flow slope per the characteristic wave shape in Fig. 7). As it would have been obvious to use derivatives of net flow including slope analysis as discussed in both Li and Xu, as well as to detect the characteristic rises/drops in acceleration associated with missed triggering, it would have been obvious to detect local minimum and maximum of the flow slope as the predictable result of the acceleration changes. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the cycling related asynchrony event discussed in Li according to the missed-triggering analysis discussed in Xu, based on rises and drops in flow slope, for the benefit of appropriately identifying the asynchrony event according to the tell-tale waveform parameters, see [0050].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Acker (US 20070028920).
Regarding claim 8, Li discloses the method of claim 1. Acker discloses, prior to detecting a cycling-related asynchrony event, receiving a user input to activate an automated synchronization mode [0021]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Li according to the “auto” option discussed in Acker, in order to verify that the clinician has accepted automatic ventilation.
Claim(s) 10 - 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Esmaeil-zadeh-azar (US 20160045694; hereinafter “Esmaeil”)
Regarding claim 10, Li discloses the method of claim 9. Esmaeil discloses, further comprising, subsequent to the first exhalation phase, detecting an auto-triggering event, and in response automatically decreasing the triggering sensitivity without additional user input (see [0043]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Li according to auto-triggering decrease in sensitivity discussed in Esmaeil for the benefit of ensuring auto-triggering does not occur prior to the patient initiating their actual inhalation.
11. The method of claim 10, wherein increasing the triggering sensitivity comprises increasing by a first amount, and decreasing the triggering sensitivity comprises decreasing by a second amount, and wherein the second amount is different than the first amount (auto-triggering may be caused by circuit vibrations/noise, creating relatively nominal flow fluctuations, whereas the increase in triggering sensitivity is associated with patient flow, creating flow changes magnitudes in difference; see [0043, 0048], Fig. 8; additionally, the triggering sensitivity should be as sensitive as possible, see [0043]; therefore, it would have been obvious to one of ordinary skill in the art to adjust the second amount associated with nominal fluctuations according to a relatively small or nominal amount in order to overcome the nominal fluctuations while still ensuring trigger sensitivity; it is additionally noted that a relatively quick increase in trigger sensitivity also ensures the safety of the patient).
12. The method of claim 11, wherein the second amount is less than the first amount (see claim 11 above).
Allowable Subject Matter
Claims 14 and 15 are 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zheng US 20140283833 A1 – adjust trigger sensitivity
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799