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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 09/08/2022 and 03/19/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 09/08/2022. As directed by the preliminary amendments, claims 8, 10, 11, 15, 17-19, 21, 24, 27-29, 31, 32, 35 and 37 have been amended. As such, claims 1-37 are being examined in this application.
Claim Objections
Claim(s) 35 is objected to because of the following informalities:
Claim 35, lines 5-6, recites “…using the range for the level of ventilatory assist…” but should recite “…using the range for a level of ventilatory assist…” due to lack of antecedent basis.
Appropriate correction is required.
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) 1-2, 4-5, 27-29 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinderby (US 20190015615 A1).
Regarding claim 1, Sinderby teaches a method for controlling a level of ventilatory assist applied to a patient by a mechanical ventilator (“…the present disclosure provides a method for controlling a level of ventilatory assist applied to a patient by a mechanical ventilator…” see [0006]), comprising:
determining a first respiratory volume of the patient during at least a part of the under-assisted breath of the patient (Sinderby teaches measuring the inspiratory volume V.sub.no-assist during the non-assisted breath which is seen as curve 202 in Fig. 2 and [0032]-[0035]);
determining a second respiratory volume of the patient during at least a part of the assisted breath of the patient for a duration matching the at least a part of the under-assisted breath of the patient (Sinderby teaches measuring the inspiratory volume V.sub.assist during the assisted breath (for a duration that matches that under-assisted breath) which is seen as curve 201 in Fig. 2 and [0032]-[0035]);
calculating a volume assistance correction based on the first and second respiratory volumes (Sinderby teaches calculating V.sub.vent which is the difference in inspiratory volume between the assisted and non-assisted breaths, wherein V.sub.vent is the patient's inspiratory volume contributed by the mechanical ventilator 902 (and therefore is taken as the volume assistance correction) as seen in Fig. 2 and [0034]-[0035]);
measuring a pressure at the mechanical ventilator or at an airway of the patient (“…a pressure sensor 913 measures the mechanical ventilatory assist pressure P.sub.vent.” see [0041]);
calculating a load of the respiratory system of the patient based on the volume assistance correction and on the pressure at the mechanical ventilator or at the airway of the patient ([0011] of applicant’s specification recites “Using NAVA to calculate the respiratory system pressure/volume curve by removing the patient's inspiratory volume generation during the non-assisted breath from that of the assisted breath and plotting it against the measured pressure assist generated by the ventilator provides a trustworthy pressure/volume curve or relationship to describe the patient's respiratory system load...” Sinderby teaches the controller 904 to be based on NAVA (Neurally Adjusted Ventilatory Assist) mechanical ventilatory assist mode as seen in [0025] and teaches calculator 915 to calculate a relation between P.sub.vent and V.sub.vent as shown in Fig. 4 and [0043]. Sinderby further teaches assessing the load of breathing (see [0002]) and overcoming 100% of the patient’s respiratory system load with ventilatory assist as seen in [0047] and [0072]. As such, the load of the patient’s respiratory system is calculated based on the pressure/volume curve shown in Fig. 4); and
controlling the mechanical ventilator according to the load of the respiratory system of the patient (“…the ventilatory assist level controlling device and method is based upon subtracting inspiratory volume V.sub.no-assist of a non-assisted breath from inspiratory volume V.sub.assist of an assisted breath, the resulting volume value will be reduced, e.g. V.sub.vent cannot reach end-inspiration volume, unless the ventilatory assist overcomes 100% of the patient's respiratory system load.” See [0047]; Sinderby teaches determining the neuromechanical efficiency of the patient's respiratory system (NMERS) and calculating the ratio of P.sub.pred/EAdi.sub.no-assist to overcome the total respiratory system load, i.e. NMERS as seen in [0072]. Sinderby further teaches using controller 904 to control mechanical ventilator 902 according to the variables of patient’s ventilatory assist as seen in [0085] to overcome the load of the respiratory system (see [0072]) and therefore is controlled according to the load).
Regarding claim 2, Sinderby teaches the method of claim 1, and further teaches wherein the first and second respiratory volumes are measured for a same value of a neural respiratory drive of the patient ([0089] of applicant’s speficiation recites “…EAdi or equivalent measure of the respiratory drive of the patient…” and therefore equates EAdi to a neural respiratory drive which can further be seen in claim 4. Sinderby teaches if two breaths have the same neural activation, one can assume that the force to expand the patient's respiratory system and inflate the lungs was similar during both breaths as seen in [0004]. Sinderby further teaches the assisted and non-assisted breath to have similar neural recruitment and similar EAdi as seen in [0031], [0034] and [0039]. Not to mention, Sinderby also relates respiratory drive to EAdi in [0050]. As such, Sinderby teaches both the inspiratory volume V.sub.no-assist (taken during the non-assisted breath) and inspiratory volume V.sub.assist (taken during the assisted breath) are measured for a same value of neural respiratory drive).
Regarding claim 4, Sinderby teaches the method of claim 2, and further teaches wherein the value of the neural respiratory drive of the patient is obtained by measuring an electrical activity of a respiratory muscle of the patient during an under-assisted breath of the patient and during an assisted breath of the patient (see claim 2 rejection above; Sinderby teaches measuring the diaphragm electrical activity (EAdi) during the non-assisted breath and the assisted breath using EAdi detector 905 as seen in [0028]. As such, the value of the neural respiratory drive is obtained as well).
Regarding claim 5, Sinderby teaches the method of claim 4, and further teaches wherein the mechanical ventilator is controlled according to the load of the respiratory system of the patient so that at least one of the following conditions is met:
a target respiratory volume is delivered to the patient,
the electrical activity of the respiratory muscle during an assisted breath of the patient meets or exceeds a target threshold, and
a total respiratory pressure of the patient is equal to a target respiratory pressure plus or minus a safety margin (Sinderby teaches comparing a target P.sub.pat% VT.sub.target to the patient's contribution P.sub.pat% VT and increasing or decreasing the NAVA level based on the comparison as seen in [0095]-[0096] and [0025] and [0049]-[0050], such that the ventilatory assist overcomes 100% of the patient's respiratory system load as seen in [0047] and [0072]).
Regarding claim 27, Sinderby teaches the method of claim 1, and further teaches wherein the under-assisted breath is a non-assisted breath (Sinderby teaches measuring the inspiratory volume V.sub.no-assist during the non-assisted breath which is seen as curve 202 in Fig. 2 and [0032]-[0035]).
Regarding claim 28, Sinderby teaches the method of claim 1, and further teaches wherein the under-assisted breath is a breath during which the mechanical ventilator provides less assist than in the assisted breath (Sinderby teaches measuring the inspiratory volume V.sub.no-assist during the non-assisted breath which is seen as curve 202 in Fig. 2 and [0032]-[0035], and therefore provides less assistance than the assisted breath).
Regarding claim 29, Sinderby teaches a system for controlling a level of ventilatory assist (ventilatory assist level controlling device 900, see Fig. 9) applied to a patient by a mechanical ventilator (mechanical ventilator 902, see Fig. 9), comprising:
a determiner (pneumatograph 907, see Fig. 9) of a respiratory volume delivered to the patient (“During an operation 1007 of measuring patient's inspiratory volume during the non-assisted breath, a pneumatograph 907 (detector) measures the inspiratory volume V.sub.no-assist during the non-assisted breath. In the same manner, during an operation 1008 of measuring patient's inspiratory volume during the assisted breath, the pneumatograph 907 measures the inspiratory volume V.sub.assist during that non-assisted breath.” See [0032]);
a pressure sensor (pressure sensor 913, see Fig. 9) adapted for measuring a pressure at the mechanical ventilator or at an airway of the patient (“…a pressure sensor 913 measures the mechanical ventilatory assist pressure P.sub.vent.” see [0041]); and
a controller (controller 904, processor 1106 and memory 1108, see Fig. 9 and Fig. 11) operatively connected to the determiner of the respiratory volume, and to the pressure sensor (controller 904 is operatively connected to pneumatograph 907 and pressure sensor 913 as seen in Fig. 9. Furthermore, Fig. 11 shows input 1102 configured to receive the EAdi, ventilator's pressure, inspiratory volume, and inspiratory flow measurements, is operatively connected to processor 1106 as seen in [0102]-[0104]), the controller comprising:
a processor (processor 1106, see Fig. 11), and
a non-transitory computer-readable medium (memory 1108, see Fig. 11) having stored thereon machine executable instructions for performing, when executed by the processor, the method according to claim 1 (“The memory 1108 may comprise a non-transient memory for storing code instructions executable by the processor 1106, specifically, a processor-readable memory comprising non-transitory instructions that, when executed, cause a processor to implement the modules of the ventilatory assist level controlling device 900 (FIG. 9) and the operations of the ventilatory assist level controlling method 1000 (FIG. 10) as described in the present disclosure.” See [0105]).
Regarding claim 31, Sinderby teaches the system of claim 29, and further teaches comprising the mechanical ventilator (mechanical ventilator 902, see Fig. 9).
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
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.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinderby (US 20190015615 A1) in view of Schomber (US 3480006 A).
Regarding claim 30, Sinderby teaches the system of claim 29, but does not teach wherein the determiner of the respiratory volume delivered to the patient comprises:
a flow meter adapted for detecting a respiratory flow of the patient; and
an integrator adapted for determining the respiratory volume delivered to the patient by integrating the respiratory flow of the patient.
However, Schomber teaches wherein the determiner of the respiratory volume delivered to the patient comprises:
a flow meter adapted for detecting a respiratory flow of the patient; and
an integrator adapted for determining the respiratory volume delivered to the patient by integrating the respiratory flow of the patient (claim 4; [00145] of applicant’s specification recites “A flow sensor 250, for example a pneumotachograph, detects a respiratory flow delivered in each breath to the patient 220 by the mechanical ventilator 210. A volume integrator 252 integrates over time the respiratory flow detected by the flow sensor 250 to obtain a respiratory volume delivered in each breath to the patient 220 by the mechanical ventilator 210.” Schomber teaches a respiratory volume measuring means using a pneumotachograph for measuring the velocity of air in a respiratory passage and an integrator connected to said pneumotachograph to determine the respiratory volume as seen in claim 4 and Col 2, lines 32-52).
Sinderby teaches a pneumatograph 907 to measure the inspiratory volume and further teacehes implementing implement at least one volume/flow detector other than a pneumatograph as seen in [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Sinderby to include the pneumotachograph and integrator taught by Schomber as an alternative method of detecting/measuring volume (see claim 4).
Claim(s) 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinderby (US 20190015615 A1) in view of Sinderby (US 20170128684 A1; hereinafter known as “Beck”).
Regarding claim 32, Sinderby teaches the system of claim 29, but does not teach further comprising an operator interface operatively connected to the controller and adapted for providing to the controller at least one configuration parameter for controlling the mechanical ventilator.
However, Beck teaches comprising an operator interface (operator interface 854, see Fig. 8) operatively connected to the controller (computer 850, see Fig. 8) (“The computer 850 may also be connected to an operator interface 854, such as for example a keyboard. Alternatively, the monitor 852 and the keyboard may be substituted by or supplemented with a touch sensitive screen (not specifically shown) displaying a graphical user interface acting at once as the monitor 852 and the operator interface 854.” See [0083]) and adapted for providing to the controller at least one configuration parameter for controlling the mechanical ventilator (mechanical ventilator 830, see Fig. 8) (Beck teaches receiving a control value at the mechanical ventilation system as a setting, in which the control value can be for a target tidal volume as seen in Fig. 1 and [0064]-[0066]. Beck further teaches computer 850 to act as a controller of the mechanical ventilator 830 in which a value of predicted body weight PBW can be entered using operator interface 854 to help determine a tidal volume as seen in [0083], [0090] and [0094]-[0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Sinderby to include the operator interface and controller as taught by Beck to allow a medical practitioner to insert values/inputs regarding the patient into the controller (see [0094]) and to manually adjust the mechanical ventilation system (see [0091]) and therefore giving the medical practitioner more control over the system.
Regarding claim 33, Sinderby in view of Beck teaches the system of claim 32, and further teaches wherein the controller further comprises a memory adapted to store the at least one configuration parameter (Sinderby teaches memory 1108 for storing code instructions executable by the processor 1106 and can further comprise a random access memory or buffer(s) to store intermediate processing data from the various functions performed by the processor 1106 as seen in [0105]. Sinderby in view of Beck teaches an operator interface 854 (taught by Beck) used to input a value of predicted body weight PBW, gender and height of the patient wherein the value/parameter is stored by memory 1108 as seen in [0105] of Sinderby).
Regarding claim 34, Sinderby in view of Beck teaches the system of claim 33, and further teaches wherein the at least one configuration parameter defines a range for the level of ventilatory assist applied to the patient by the mechanical ventilator, a low end of the range causing the mechanical ventilator to provide no assist to the patient, a high end of the range causing the mechanical ventilator to fulfill a totality of a ventilatory need of the patient (Sinderby teaches controller 904 to command the mechanical ventilator 902 to provide no ventilatory assist or to provide ventilatory assist as seen in [0026]-[0027]. Beck teaches entering a value of PBW on the operator interface 854 which can be used to determine the nominal tidal volume Vt.sub.PBW in which the controller would have all the necessary parameters for computing the level of ventilatory assist ASSIST to adjust the level of ventilatory assist to the patient as seen in [0094]-[0102]. Therefore, Sinderby in view of Beck teaches the value of PBW to help define a range for the level of ventilatory assist (see [0064]-[0066] of Beck), wherein the range is from no assist to a total assist).
Regarding claim 35, Sinderby in view of Beck teaches the system of claim 33, and further teaches further comprising an electrical sensor (EAdi detector 905, see Fig. 9 and [0029]) operatively connected to the controller (see Fig. 9), the electrical sensor being adapted for detecting an electrical activity of a respiratory muscle of the patient (EAdi detector 905 measure the patient's diaphragm electrical activity (EAdi) as seen in [0025] and [0028]), wherein the controller is adapted to:
control an initial operation of the mechanical ventilator using the range for the level of ventilatory assist applied to the patient by the mechanical ventilator defined by the at least one configuration parameter (Beck teaches entering a value of PBW on the operator interface 854 which can be used to determine the nominal tidal volume Vt.sub.PBW in which the controller would have all the necessary parameters for computing the level of ventilatory assist ASSIST to adjust the level of ventilatory assist to the patient as seen in [0094]-[0102]. As such, Sinderby in view of Beck teaches controlling an initial operation of mechanical ventilator 902 (taught by Sinderby) using the range for a level of ventilatory assist defined by the at least one configuration parameter by entering a value of PBW on the operator interface 854 (taught by Beck));
implement a recurring sequence, each instance of the sequence comprising controlling the mechanical ventilator for at least one under- assisted breath and for a plurality of assisted breaths (Sinderby teaches measuring the inspiratory volume V.sub.no-assist during the non-assisted breath in operation 1007, measuring the inspiratory volume V.sub.assist during the assisted breath in operation 1008 and calculating a V.sub.vent which is the difference in inspiratory volume between the assisted and non-assisted breaths in operation 1009 as seen in Fig. 10 and [0032] and [0034]. Sinderby further teaches operation 1014 in which a calculator 914 calculates a relation between the mechanical ventilatory assist pressure P.sub.vent and the inspiratory volume V.sub.assist and operation 1015 in which a calculator 915 calculates a relation between the mechanical ventilatory assist pressure P.sub.vent and the inspiratory volume V.sub.vent as seen in Fig. 10 and [0042]-[0043]. Operation 1016 determines a ratio between values of the ventilator's assist pressure P.sub.vent at same inspiratory volumes V.sub.vent and V.sub.assist for a plurality of inspiratory volumes V.sub.vent and V.sub.assist. as seen in [0053]-[0054]. As such, Sinderby in view of Beck teaches at least one under-assisted breath for operation 1015 and a plurality of assisted breaths for operations 1014 and 1015 for operation 1016 (taught by Sinderby) and further teaches operations to be repeated until the control value is met (see [0037] of Beck)); and
following each instance of the sequence:
recalculate the load of the respiratory system of the patient using electrical activity measurements of the respiratory muscle of the patient, respiratory volume determinations and pressure measurements obtained in the course of the sequence (Sinderby teaches using electrical activity EAdi, V.sub.vent and P.sub.vent to overcome the total respiratory system load i.e. NMERS as seen in Fig. 10 and [0052]-[0055] and [0071]-[0073] in which the load is to be assessed as seen in [0002] such that the pressure can overcome the patient’s respiratory system load to generate inspiratory volume as seen in [0044]. [0047] and [0072]. As such, Sinderby in view of Beck teaches recalculating the load/NMERS in operation 1023 which relies on operation 1022 and 1018 (and therefore operations 1014-1017) as seen in Fig. 10 of Sinderby and further teaches operations to be repeated until the control value is met (see [0037] of Beck)), and
modify control of the mechanical ventilator according to the recalculated load of the respiratory system of the patient (Sinderby teaches adjusting the mechanical ventilatory assist to the load of breathing as seen in [0002] such that the pressure can overcome the patient’s respiratory system load to generate inspiratory volume as seen in [0044]. [0047] and [0072]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinderby (US 20190015615 A1) in view of Sinderby (US 20170128684 A1; hereinafter known as “Beck”), as applied to claim 35 above, and further in view of O’Connor (US 20040118403 A1).
Regarding claim 36, Sinderby in view of Beck teaches the system of claim 35, but does not teach wherein: the at least one configuration parameter further comprises:
an inclusion criterion for the electrical activity measurements,
an inclusion criterion for respiratory volume determinations, and
an inclusion criterion for pressure measurements; and
the controller is further adapted for ignoring measurements obtained during a given assisted or under-assisted breath when recalculating the load of the respiratory system of the patient when at least one of the inclusion criteria is not met.
[00157] of applicant’s specification recites “In the same or another non-limiting embodiment, the flow sensor 250, the volume integrator 252 or the controller 300 evaluates the quality of the obtained under-assisted and assisted breaths to exclude measurements that fail to meet some inclusion criteria. The criteria may include, for example, that for either breath a target limit should be exceeded for a flow or a volume…The criteria may include, for example, that a lower pressure threshold should be exceed for either breaths.” O’Connor teaches a controller 32 (see [0041]) and learn mode as seen in [0093], wherein if the mask pressure exceeds a threshold value, the learn process is stopped and the determined values may be ignored/disregarded as seen in [0108]. Similarly, if any predetermine flow level in the test range cannot be generated, the learn mode may be aborted as seen in [0108].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Sinderby in view of Beck to include the controller and learn mode as taught by O’Connor to ignore/disregard measurements that exceeds a threshold value to remove errors (see [0108]). Modified Sinderby teaches wherein: the at least one configuration parameter further comprises:
an inclusion criterion for the electrical activity measurements,
an inclusion criterion for respiratory volume determinations, and
an inclusion criterion for pressure measurements; and
the controller is further adapted for ignoring measurements obtained during a given assisted or under-assisted breath when recalculating the load of the respiratory system of the patient when at least one of the inclusion criteria is not met (Sinderby teaches measuring EAdi (see [0028]-[0029]), measuring patient's inspiratory volume as seen in [0032]-[0034] and measuring the mechanical ventilatory assist pressure P.sub.vent as seen in [0041]. Beck teaches entering a value of PBW on the operator interface 854 which can be used to determine the nominal tidal volume Vt.sub.PBW in which the controller would have all the necessary parameters for computing the level of ventilatory assist ASSIST to adjust the level of ventilatory assist to the patient as seen in [0094]-[0102] (which uses electrical activity measurements, respiratory volume determinations and pressure measurements). O’Connor teaches ignoring/disregarding determined values if pressure/flow exceeds a threshold value as seen in [0108]. As such, modified Sinderby teaches using an inclusion criterion for electrical activity measurements, respiratory volume determinations, and pressure measurements and ignoring measurements when one of the inclusion criteria is not met).
Allowable Subject Matter
Claim(s) 3, 6-26 and 37 is/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.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 3 recites “further comprising using respiratory volume measurements of the patient obtained over a plurality of under-assisted breaths of the patient and over a plurality of assisted breaths of the patient to predict a value of the neural respiratory drive of the patient based on a statistical probability of a similar mean neural drive between the under-assisted and assisted breaths of the patient.” Sinderby (US 20190015615 A1) teaches a respiratory drive depending on the patients neuro-mechanical efficiency (NME) as seen in [0050], but does not teach “comprising using respiratory volume measurements of the patient obtained over a plurality of under-assisted breaths of the patient and over a plurality of assisted breaths of the patient to predict a value of the neural respiratory drive of the patient based on a statistical probability of a similar mean neural drive between the under-assisted and assisted breaths of the patient.” As a result, because no references of record or reasonable conclusion thereof, could be found which disclose or suggest all features of claim 3, claim 3 is allowable subject matter over prior arts. Claims 20-26 depend from claim 3 and are considered allowable subject matter by virtue of their dependency on claim 3.
Claim 6 recites “further comprising: determining a time of an earliest peak of electrical activity between the electrical activity of the respiratory muscle of the patient measured during the under-assisted breath and the electrical activity of the respiratory muscle of the patient measured during the assisted breath of the patient; wherein: the first respiratory volume of the patient is determined from a start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity; the second respiratory volume of the patient is determined from a start of the assisted breath of the patient until the time of the earliest peak of electrical activity; and the pressure is measured at the mechanical ventilator or at the airway of the patient at the time of the earliest peak of electrical activity.” Sinderby (US 20190015615 A1) teaches comparing peak EAdi between assisted and non-assisted breaths as seen in [0091]-[0093] but does not teach determining a time of an earliest peak of electrical activity between the electrical activity of the respiratory muscle of the patient measured during the under-assisted breath and the electrical activity of the respiratory muscle of the patient measured during the assisted breath of the patient; wherein: the first respiratory volume of the patient is determined from a start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity; the second respiratory volume of the patient is determined from a start of the assisted breath of the patient until the time of the earliest peak of electrical activity; and the pressure is measured at the mechanical ventilator or at the airway of the patient at the time of the earliest peak of electrical activity. Garcia (US 20160220783 A1) teaches a first electrical activity peak, a second electrical activity peak and a duration of time between the first electrical activity peak and second electrical activity peak as seen in [0042]-[0044]. However, even if Sinderby was modified by Garcia, Sinderby in view of Garcia does not teach “the first respiratory volume of the patient is determined from a start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity; the second respiratory volume of the patient is determined from a start of the assisted breath of the patient until the time of the earliest peak of electrical activity; and the pressure is measured at the mechanical ventilator or at the airway of the patient at the time of the earliest peak of electrical activity.” As a result, because no references of record or reasonable conclusion thereof, could be found which disclose or suggest all features of claim 6, claim 6 is allowable subject matter over prior arts. Claims 7-8 depend from claim 6 and are considered allowable subject matter by virtue of their dependency on claim 6.
Claim 9 recites “wherein the volume assistance correction is calculated as follows:
VAssistCorr = VAssist@EAdiPeak1 - VAssist@EAdiPeak1 * (VNoAssist@EAdiPeak1 / VAssist@EAdiPeak1)n;
wherein:
VAssistCorr is the volume assistance correction,
VNoAssist@EAdiPeak1 is the first respiratory volume of the patient measured from the start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity,
VAssist@EAdiPeak1 is the second respiratory volume of the patient measured from the start of the assisted breath of the patient until the time of the earliest peak of electrical activity, and
n is a power factor selected from 2 and 3.” Sinderby (US 20190015615 A1) teaches a calculating V.sub.vent which is the difference in inspiratory volume between the assisted and non-assisted breaths, wherein V.sub.vent is the patient's inspiratory volume contributed by the mechanical ventilator 902 as seen in Fig. 2 and [0034]-[0035]. Sinderby (US 20120103334 A1; hereinafter known as Christer) teaches a patient-ventilator breath contribution (PVBC) index calculated as PVBC = (Vt/ EAdi no-assist)/ (Vt/ EAdiassist) as seen in [0057]. However, neither prior art teaches wherein the volume assistance correction is calculated as follows: VAssistCorr = VAssist@EAdiPeak1 - VAssist@EAdiPeak1 * (VNoAssist@EAdiPeak1 / VAssist@EAdiPeak1)n. As a result, because no references of record or reasonable conclusion thereof, could be found which disclose or suggest all features of claim 9, claim 9 is allowable subject matter over prior arts. Claims 11-19 depend from claim 9 and are considered allowable subject matter by virtue of their dependency on claim 9.
Claim 10 recites “wherein the volume assistance correction is calculated as follows:
VAssistCorr = VAssist@EAdiPeak1 - VAssist@EAdiPeak1 * (FNoAssist@EAdiPeak1 / FAssist@EAdiPeak1)n;
wherein:
VAssistCorr is the volume assistance correction,
VAssist@EAdiPeak1 is the second respiratory volume of the patient measured from the start of the assisted breath of the patient until the time of the earliest peak of electrical activity,
FNoAssist@EAdiPeak1 is a first respiratory flow of the patient measured between the start of the under-assisted breath of the patient and the time of the earliest peak of electrical activity,
FAssist@EAdiPeak1 is a second respiratory flow of the patient measured between the start of the assisted breath of the patient and the time of the earliest peak of electrical activity, and
n is a power factor selected from 2 and 3.” Sinderby (US 20190015615 A1) teaches a calculating V.sub.vent which is the difference in inspiratory volume between the assisted and non-assisted breaths, wherein V.sub.vent is the patient's inspiratory volume contributed by the mechanical ventilator 902 as seen in Fig. 2 and [0034]-[0035]. However, Sinderby does not teach wherein the volume assistance correction is calculated as follows: VAssistCorr = VAssist@EAdiPeak1 - VAssist@EAdiPeak1 * (FNoAssist@EAdiPeak1 / FAssist@EAdiPeak1)n. As a result, because no references of record or reasonable conclusion thereof, could be found which disclose or suggest all features of claim 10, claim 10 is allowable subject matter over prior arts.
Claim 37 recites “wherein the processor is further adapted to: calculate a spontaneous breathing prediction for the patient based on the calculated load of the respiratory system of the patient; store the spontaneous breathing prediction for the patient in the memory; and use the stored spontaneous breathing prediction for the patient for back-up control of the level of ventilatory assist to the patient when the patient is not spontaneous breathing.” Sinderby (US 20190015615 A1) teaches overcoming the load of the respiratory system as seen in [0072], but does not teach calculating a spontaneous breathing prediction for the patient based on the calculated load of the respiratory system of the patient. As a result, because no references of record or reasonable conclusion thereof, could be found which disclose or suggest all features of claim 37, claim 37 is allowable subject matter over prior arts.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Watarai (US 20190029547 A1) teaches excluding and discarding a respiratory rate exceeding the threshold value from the target of the averaging process.
Sinderby (US 20120006327 A1) teaches determining a level of ventilatory assist to be delivered to a patient by a mechanical ventilator in response to a measure of a patient's neural respiratory drive multiplied by an amplification factor.
Thakker (US 20190175908 A1) teaches stimulating a respiratory muscle of a patient and the electrical activity of the diaphragm can provide an accurate reflection of the patient's neural respiratory drive.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785