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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
Status of Claims
This Office Action is in response to the remarks and amendments filed on May 4th, 2026. Claim 9 has been canceled as such claims 1-8 and 10-20 are pending consideration in this Office Action.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
Claim 1, lines 2, 15, and 16, “a ventilation device” in line 2 should read “a ventilator” or “the ventilator” in lines 15 and 16 should read “the ventilation device”
Claim 12, lines 2, 20, and 21, “a ventilation device” in line 2 should read “a ventilator” or “the ventilator” in lines 20 and 21 should read “the ventilation device”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-8 and 10-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-8 and 10-20 recites at least one step or instruction for determining a patient component based on a filtered muscle pressure, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-8 and 10-20 recites an abstract idea.
Specifically, Claim 1 recites
a device for determining a patient component of an exchange of gas of a patient being ventilated (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG), for a measuring device or a ventilation device (additional element), the device comprising:
an interface configuration comprising one or more interfaces (additional element) configured for an exchange of information with the measuring device or with the ventilation device (additional element) during a patient measurement or during a patient ventilation (prior insignificant extra-solutional activity);
a control unit (additional element) configured:
to determine a time course of a respiratory muscle pressure of the patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
to carry out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
to determine the patient component based on the time course of the filtered respiratory muscle pressure during the patient measurement or during the patient ventilation (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG)
wherein the control unit is configured to output a trigger signal for the ventilator (post insignificant extra-solutional activity); and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins (post insignificant extra-solutional activity).
Specifically, Claim 12 recites
a measuring device or ventilation device system comprising:
a measuring device or ventilation device (additional element); and
a device (additional element) for determining a patient component of an exchange of gas of a patient being ventilated (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG),
the device comprising: an interface configuration comprising one or more interfaces (additional element) configured for an exchange of information with the measuring device or with the ventilation device (additional element; prior insignificant extra-solutional activity);
a control unit (additional element) configured:
to determine a time course of a respiratory muscle pressure of the patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
to carry out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
to determine the patient component based on the time course of the filtered respiratory muscle pressure (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG),
wherein the interface is configured to send the determined patient component to the measuring device or ventilation device (post insignificant extra-solutional activity) and
the measuring device or ventilation device (additional element) is configured to receive the determined patient component from the interface and to synchronize the measuring device or ventilation device to the determined patient component or set ventilation parameters based on the determined patient component (post insignificant extra-solutional activity)
wherein the control unit is configured to output a trigger signal for the ventilator (post insignificant extra-solutional activity); and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins (post insignificant extra-solutional activity).
Specifically, Claim 18 recites
A process for determining a patient component of a gas exchange of a patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG) being ventilated (insignificant extra-solution), the process comprising process steps of:
detecting and determining a time course of a respiratory muscle pressure of the patient based on an electromyographic signal, or a pneumatic signal or a mechanical signal during a patient ventilation (prior insignificant extra-solutional activity);
performing an adapted high-pass filtering for the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
determining the patient component of the airway flow based on the time course of the filtered respiratory muscle pressure during the patient ventilation (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-8, 10, 11, 13-17, and 19-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1, 12, and 18 (and their respective dependent Claims 2-8, 10, 11, 13-17, and 19-20) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 12, and 18), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of:
a measuring device or a ventilation device, an interface configuration comprising one or more interfaces, and a control unit as recited in independent claim 1 and its dependents
a measuring device or a ventilation device, a device comprising: an interface configuration comprising one or more interfaces, and a control unit as recited in independent claim 12 and its dependents
a computer, a processor, or programmable hardware component as recited in dependent claim 20
are generically recited computer which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 12, and 18 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (control unit, computer, processor, or programmable hardware component as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 12, and 18 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 12, and 18 (and its respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-8 and 10-20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
Independent claims 1, 12, and 18 requires the additional elements of:
a measuring device or a ventilation device, an interface configuration comprising one or more interfaces, and a control unit as recited in independent claim 1 and its dependents
a measuring device or a ventilation device, a device comprising: an interface configuration comprising one or more interfaces, and a control unit as recited in independent claim 12 and its dependents
a computer, a processor, or programmable hardware component as recited in dependent claim 20
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, a basic embodiment may comprise a computer program with a program code for carrying out at least one of the above-described embodiments. The program code may advantageously be executed on a computer, on a processor or on a programmable hardware component [0172] and any desired processor core or even a plurality of processor cores or microcontrollers are conceivable for implementing a control unit [0071].
Accordingly, in light of Applicant’s specification, the claimed term a computer, a processor, or a programmable hardware component is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computer, processor, or programmable hardware component. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-8 and 10-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, process of Claims 1-8 and 10-20 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-8 and 10-20 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 12, and 18 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-8 and 10-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-8 and 10-20 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1-8 and 10-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
While independent claims 1 and 12 initially appears to integrate the claims in practical application using the controller to control the ventilator with trigger/cycling-off signals, the limitation as claimed uses an and/or statement where “the control unit is configured to output a trigger signal for the ventilator; and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins”. This creates issues as the and/or statement means it can be the first half or the second half of the limitation. The first half of the limitation “wherein the control unit is configured to output a trigger signal for the ventilator” does not link the abstract idea into practical application as it is not controlling the ventilator based on the determined patient component (abstract idea). The second half of the limitation is also unclear if it integrates into practical application as “a breathing effort of the patient” as recited is not linked to the determined patient component.
It is recommended to amend “wherein the control unit is configured to output a trigger signal for the ventilator; and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins” to instead read
“wherein the control unit is configured to output a trigger signal for the ventilator based on the determined patient component; and/or the control unit is configured to output a cycling-off signal for the ventilator based on the determined patient component” in order to integrate independent claims 1 and 12 (and their dependents) into practical application.
It is recommended to amend claim 18 to further include a similar limitation to claims 1 and 12 such as “controlling a ventilator by outputting a trigger signal for the ventilator based on the determined patient component and/or outputting a cycling-off signal for the ventilator based on the determined patient component”.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-3, 5-7, 11-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eger (US 20090159082) in view of Vicario (US 20210205558) and further in view of Mulqueeny (WO 2010121313).
Regarding claim 1, Eger discloses
a device for determining a patient component of an exchange of gas of a patient being ventilated, for a measuring device or a ventilation device (fig. 1; a respiration system for proportional assist ventilation with a control unit, EMG electrodes 1, 2 and ventilator 5 that determines a respiratory effort; abstract, [0011], [0040]), the device comprising:
a control unit configured: to determine a time course of a respiratory muscle pressure of the patient (figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated);
a t = R/E relationship as a time constant (determining the time constant .tau. during a passive period of the breathing cycle during inspiration or expiration according to E=R/.tau.; [0061], rearranged, tau =R/E), wherein R and E are lung mechanical parameters of the patient being ventilated (lung mechanical parameters resistance (R), elastance (E) of the patient; [0058]-[0064]), wherein R is the resistance (lung mechanical parameter resistance (R); [0058]-[0064]) and E is the elastance of the patient's lung (lung mechanical parameter elastance (E); [0058]-[0064]);
to determine the patient component based on the time course of the respiratory muscle pressure during the patient measurement or during the patient ventilation (determining a respiratory effort pressure p.sub.pat(t) by the control unit as a weighted mean according to p.sub.pat(t)=ap.sub.mus(t)+(1-a)p.sub.emg(t); claim 1 and 37; [0014], [0025]; volume flow of the patient is also correlated with p.sub.mus(t); [0012])
While Eger does disclose an exchange of information with the measuring device or with the ventilation device during a patient measurement or during a patient ventilation (fig. 1; signals generated by electrodes are subjected to signal processing in the control means and ventilator is set by the control until; claim 1; [0011]; therefore, signals are transmitted between the electrodes, control unit, and ventilator), it does not explicitly disclose an interface configuration comprising one or more interfaces configured for an exchange of information with the measuring device or with the ventilation device during a patient measurement or during a patient ventilation; and the control unit configured: to carry out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung; and to determine the patient component based on the time course of the filtered respiratory muscle pressure; wherein the control unit is configured to output a trigger signal for the ventilator; and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins.
Vicario discloses an analogous respiratory monitory apparatus that determines a respiratory muscle pressure P.sub.mus(t) and comprises
an interface configuration comprising one or more interfaces (communication network (e.g., a wireless network, a local area network, a wide area network, a personal area network, BLUETOOTH®, and the like; [0086]) configured for an exchange of information with the measuring device or with the ventilation device during a patient measurement or during a patient ventilation (figs. 1-14; the various signals and values (air flow, ECG, described herein can be communicated to the various processors 36, 38, 40, 58 and components ventilator 12, display 22, estimating processor 42, WoB calculator 44, closed loop controller 60 via a communication network (e.g., a wireless network, a local area network, a wide area network, a personal area network, BLUETOOTH®, and the like); [0086])
the control unit (fig. 14; processors 36, 38, 40, 42, 58, calculator 44, and controller 60; [0085]-[0086] and [0089]) configured:
to carry out a filtering of the time course of the respiratory muscle pressure (fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]) and
to determine the patient component based on the time course of the filtered respiratory muscle pressure (fig. 14; controller 60 and WOB calculator 44 uses p.sub.mus(t) to compute patient work of breath and power of breath, [0075] and [0085]; and detection processor 40 with classification processor 58 is used to detect abnormalities and asynchronies extracted from the p.sub.mus,surr signal; [0081]-[0083]; fig. 1; signals are analyzed; [0043]-[0044])
wherein the control unit is configured to output a trigger signal for the ventilator (fig. 14; classification processor 58 and controller 60 is used to adjust the ventilator setting based on asynchronies (see Table 1 on page 8; corrective actions for triggering asynchronies) and the difference between the actual and desired power or work of breathing in order to optimally support the patient's spontaneous respiratory effort [0083]); and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control and analysis unit of Eger with the various processors and controllers as disclosed in Vicario to provide filtering, signal to noise ratio reduction, data smoothing, and identify asynchronies in the filtered muscle pressure p.usb.mus(t) for adjusting ventilation (Vicario: [0076], [0080]-[0085] and [0087]-[0088]). Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control means and ventilator of Eger with the communication network of Vicario to yield the predictable results of communicating the various signals and values to the processors and components such as the ventilator (Vicario: [0086]).
The modified device of Eger does not explicitly disclose carrying out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung.
Mulqueeny discloses methods and devices for automating detection of asynchrony where
high-pass filtering using a t = R/E relationship as a time constant to obtain a filtered signal (a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating), wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (Tau = R*C. The patient's time constant (Tau) , a respiratory mechanics based feature, may also be determined as the resistance times the compliance; where R is resistance and C is compliance of the respiratory system; [0065]; while this does not explicitly state t=R/E, it would have been readily understood that elastance is the inverse of compliance (C=1/E); therefore, the time constant Tau =R*C is equivalent to tau = R/E)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filtering of the muscle pressure p.sub.mus(t) of the modified device of Eger with the filtering technique of Mulqueeny to provide a smoother version of the original signal (Mulqueeny: [0065]-[0071] and [0106]).
It directly follows that the resultant control unit and filtering of the modified device of Eger combined with the filtering technique of Mulqueeny would meet the claimed structural limitations since:
to carry out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]), wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (Mulqueeny: Tau = R*C. The patient's time constant (Tau) , a respiratory mechanics based feature, may also be determined as the resistance times the compliance; where R is resistance and C is compliance of the respiratory system; [0065]; while this does not explicitly state t=R/E, it would have been readily understood that elastance is the inverse of compliance (C=1/E); therefore, the time constant Tau =R*C is equivalent to tau = R/E; Eger: determining the time constant .tau. during a passive period of the breathing cycle during inspiration or expiration according to E=R/.tau.; [0061], rearranged, tau =R/E).
Regarding claim 2, Eger further discloses
a device (a respiration system for proportional assist ventilation) in accordance with claim 1,
wherein the control unit is configured to carry out the determination of the time course of the respiratory muscle pressure based on an electromyographic signal, a pneumatic signal or a mechanical signal (figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t) using the signals determined for the breathing activity u.sub.emg(t), airway pressure and volume flow; claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated).
Regarding claim 3, the modified device of Eger further discloses
a device (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 1,
wherein the control unit is configured to carry out the high-pass filtering in the time domain (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating where the filter uses the time constant/is done in the time domain) in order to obtain the time course of the filtered respiratory muscle pressure (Mulqueeny: subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]).
Regarding claim 5, the modified device of Eger discloses
a device (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 1,
wherein the patient component of the exchange of gas comprises a minute volume or a tidal volume, which is based on a spontaneous activity of the patient.
While Eger does not explicitly disclose “wherein the patient component of the exchange of gas comprises a minute volume or a tidal volume, which is based on a spontaneous activity of the patient”, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the modified device of Eger would have been able to calculate the tidal volume based on a spontaneous activity of the patient (Vicario: patient’s spontaneous respiratory effort, [0085]; Eger: patient’s respiratory effort, [0014], [0025]) as Eger discloses a mathematical relationship between respiratory muscle pressure p.sub.mus(t) and volume flow Flow(t) which can be used to determine tidal volume Vol(t) through integration (Eger: [0012]).
Regarding claim 6, the modified device of Eger further discloses
a device (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 1,
wherein the control unit is configured to determine a high-pass characteristic for the adapted performance of the high-pass filtering (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average; [0065]-[0071]; the time constant tau (high-pass characteristic) is used in the filtering/de-trending to obtain high-frequencies/perform a high-pass filtering operating) based on at least one of:
the time course of the respiratory muscle pressure; and a kinetic equation for the breathing circuit of the patient (Mulqueeny: where Pressure = Flow*R + Volume/C + PEEPtot is also used to determine lung mechanics and tau; [0065] and Eger: parameters of tau=R/E is determined using linear regression and lung mechanical equations; [0058]-[0064] and p.sub.mus(t) is determined from measured values of airway pressure, volume flow, and lung parameters E=R/T; claim 1, [0058]-[0064]).
Regarding claim 7, the modified device of Eger further discloses
a device in accordance (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) with claim 6,
wherein the control unit is configured to determine the high-pass characteristic by performing a linear regression (Mulqueeny: automated determination of resistance R and compliance C values for the feature sets as previously described may be calculated by a multiple linear regression method; [0065] and [0121]; where the time constant (high-pass characteristic) tau =R*C is equivalent to tau =R/E ), a Kalman filtering or an estimation based on the kinetic equation (Mulqueeny: where Pressure = Flow*R + Volume/C + PEEPtot is also used to determine lung mechanics and tau; [0065] and Eger: parameters of tau=R/E is determined using linear regression and lung mechanical equations; [0058]-[[0064]).
Regarding claim 11, Eger further discloses
a device (a respiration system for proportional assist ventilation) in accordance with claim 2, further comprising:
electrodes for detecting the electromyographic signal (fig. 1; two signal electrodes (1, 2); [0040]); or sensors for detecting the pneumatic signal (an esophageal catheter, which is equipped with pressure sensors for measuring the intrathoracic pressure p.sub.es(t) and optionally the abdominal pressure p.sub.abd(t); [0012]); or sensors for detecting the mechanical signal.
Regarding claim 12, Eger discloses
a measuring device or ventilation device system (fig. 1; a respiration system for proportional assist ventilation; abstract, [0011], [0040]) comprising:
a measuring device or ventilation device (fig. 1; EMG electrodes 1, 2 and ventilator 5’ [0011], [0040]); and
a device for determining a patient component of an exchange of gas of a patient being ventilated (fig. 1; control unit that determines a respiratory effort; abstract, [0011], [0040]), the device comprising:
a control unit configured: to determine a time course of a respiratory muscle pressure of the patient (figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated);
a t = R/E relationship as a time constant (determining the time constant .tau. during a passive period of the breathing cycle during inspiration or expiration according to E=R/.tau.; [0061], rearranged, tau =R/E), wherein R and E are lung mechanical parameters of the patient being ventilated (lung mechanical parameters resistance (R), elastance (E) of the patient; [0058]-[0064]), wherein R is the resistance (lung mechanical parameter resistance (R); [0058]-[0064]) and E is the elastance of the patient's lung (lung mechanical parameter elastance (E); [0058]-[0064]);
to determine the patient component based on the time course of the respiratory muscle pressure during the patient measurement or during the patient ventilation (determining a respiratory effort pressure p.sub.pat(t) by the control unit as a weighted mean according to p.sub.pat(t)=ap.sub.mus(t)+(1-a)p.sub.emg(t); claim 1 and 37; [0014], [0025]; volume flow of the patient is also correlated with p.sub.mus(t); [0012])
While Eger does disclose an exchange of information with the measuring device or with the ventilation device during a patient measurement or during a patient ventilation (fig. 1; signals generated by electrodes are subjected to signal processing in the control means and ventilator is set by the control until; claim 1; [0011]; therefore, signals are transmitted between the electrodes, control unit, and ventilator), it does not explicitly disclose an interface configuration comprising one or more interfaces configured for an exchange of information with the measuring device or with the ventilation device during a patient measurement or during a patient ventilation; and the control unit configured: to carry out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung; and to determine the patient component based on the time course of the filtered respiratory muscle pressure; wherein the interface is configured to send the determined patient component to the measuring device or ventilation device and the measuring device or ventilation device is configured to receive the determined patient component from the interface and to synchronize the measuring device or ventilation device to the determined patient component or set ventilation parameters based on the determined patient component wherein the control unit is configured to output a trigger signal for the ventilator; and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins.
Vicario discloses an analogous respiratory monitory apparatus that determines a respiratory muscle pressure P.sub.mus(t) and comprises
an interface configuration comprising one or more interfaces (communication network (e.g., a wireless network, a local area network, a wide area network, a personal area network, BLUETOOTH®, and the like; [0086]) configured for an exchange of information with the measuring device or with the ventilation device during a patient measurement or during a patient ventilation (figs. 1-14; the various signals and values (air flow, ECG, described herein can be communicated to the various processors 36, 38, 40, 58 and components ventilator 12, display 22, estimating processor 42, WoB calculator 44, closed loop controller 60 via a communication network (e.g., a wireless network, a local area network, a wide area network, a personal area network, BLUETOOTH®, and the like); [0086])
the control unit (fig. 14; processors 36, 38, 40, 42, 58, calculator 44, and controller 60; [0085]-[0086] and [0089]) configured:
to carry out a filtering of the time course of the respiratory muscle pressure (fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]) and
to determine the patient component based on the time course of the filtered respiratory muscle pressure (fig. 14; controller 60 and WOB calculator 44 uses p.sub.mus(t) to compute patient work of breath and power of breath, [0075] and [0085]; and detection processor 40 with classification processor 58 is used to detect abnormalities and asynchronies extracted from the p.sub.mus,surr signal; [0081]-[0083]; fig. 1; signals are analyzed; [0043]-[0044]);
wherein the interface is configured to send the determined patient component to the measuring device or ventilation device (figs. 1-14; the various signals and values (air flow, ECG, described herein can be communicated to the various processors 36, 38, 40, 58 and components ventilator 12, display 22, estimating processor 42, WoB calculator 44, closed loop controller 60 via a communication network (e.g., a wireless network, a local area network, a wide area network, a personal area network, BLUETOOTH®, and the like); [0086]) and the measuring device or ventilation device is configured to receive the determined patient component from the interface and to synchronize the measuring device or ventilation device to the determined patient component or set ventilation parameters based on the determined patient component (fig. 14; classification processor 58 and controller 60 is used to adjust the ventilator setting based on asynchronies (see Table 1 on page 8; corrective actions for triggering asynchronies) and the difference between the actual and desired power or work of breathing in order to optimally support the patient's spontaneous respiratory effort [0083]; therefore, signals and values of asynchronies and the breathing effort of the patient are sent to the ventilator 12 for adjustment based on asynchronies);
wherein the control unit is configured to output a trigger signal for the ventilator (fig. 14; classification processor 58 and controller 60 is used to adjust the ventilator setting based on asynchronies (see Table 1 on page 8; corrective actions for triggering asynchronies) and the difference between the actual and desired power or work of breathing in order to optimally support the patient's spontaneous respiratory effort [0083]); and/or the control unit is configured to output a cycling-off signal for the ventilator based on times at which a breathing effort of the patient begins.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control and analysis unit of Eger with the various processors and controllers as disclosed in Vicario to provide filtering, signal to noise ratio reduction, data smoothing, and identify asynchronies in the filtered muscle pressure p.usb.mus(t) for adjusting ventilation (Vicario: [0076], [0080]-[0085] and [0087]-[0088]). Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control means and ventilator of Eger with the communication network of Vicario to yield the predictable results of communicating the various signals and values to the processors and components such as the ventilator (Vicario: [0086]).
The modified device of Eger does not explicitly disclose carrying out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung.
Mulqueeny discloses methods and devices for automating detection of asynchrony where
high-pass filtering using a t = R/E relationship as a time constant to obtain a filtered signal (a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating), wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (Tau = R*C. The patient's time constant (Tau) , a respiratory mechanics based feature, may also be determined as the resistance times the compliance; where R is resistance and C is compliance of the respiratory system; [0065]; while this does not explicitly state t=R/E, it would have been readily understood that elastance is the inverse of compliance (C=1/E); therefore, the time constant Tau =R*C is equivalent to tau = R/E)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filtering of the muscle pressure p.sub.mus(t) of the modified device of Eger with the filtering technique of Mulqueeny to provide a smoother version of the original signal (Mulqueeny: [0065]-[0071] and [0106]).
It directly follows that the resultant control unit and filtering of the modified device of Eger combined with the filtering technique of Mulqueeny would meet the claimed structural limitations since:
to carry out a high-pass filtering of the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]), wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (Mulqueeny: Tau = R*C. The patient's time constant (Tau) , a respiratory mechanics based feature, may also be determined as the resistance times the compliance; where R is resistance and C is compliance of the respiratory system; [0065]; while this does not explicitly state t=R/E, it would have been readily understood that elastance is the inverse of compliance (C=1/E); therefore, the time constant Tau =R*C is equivalent to tau = R/E; Eger: determining the time constant .tau. during a passive period of the breathing cycle during inspiration or expiration according to E=R/.tau.; [0061], rearranged, tau =R/E).
Regarding claim 13, Eger further discloses
a measuring device or ventilation device system (a respiration system for proportional assist ventilation) in accordance with claim 12,
wherein the control unit is configured to carry out the determination of the time course of the respiratory muscle pressure based on an electromyographic signal, a pneumatic signal or a mechanical signal (figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t) using the signals determined for the breathing activity u.sub.emg(t), airway pressure and volume flow; claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated).
Regarding claim 14, the modified device of Eger further discloses
a measuring device or ventilation device system (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 12,
wherein the control unit is configured to carry out the high-pass filtering in the time domain (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating where the filter uses the time constant/is done in the time domain) in order to obtain the time course of the filtered respiratory muscle pressure (Mulqueeny: subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]).
Regarding claim 16, the modified device of Eger discloses
a measuring device or ventilation device system (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 12,
wherein the patient component of the exchange of gas comprises a minute volume or a tidal volume, which is based on a spontaneous activity of the patient.
While Eger does not explicitly disclose “wherein the patient component of the exchange of gas comprises a minute volume or a tidal volume, which is based on a spontaneous activity of the patient”, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the modified device of Eger would have been able to calculate the tidal volume based on a spontaneous activity of the patient (Vicario: patient’s spontaneous respiratory effort, [0085]; Eger: patient’s respiratory effort, [0014], [0025]) as Eger discloses a mathematical relationship between respiratory muscle pressure p.sub.mus(t) and volume flow Flow(t) which can be used to determine tidal volume Vol(t) through integration (Eger: [0012]).
Regarding claim 17, the modified device of Eger further discloses
a measuring device or ventilation device system (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 12,
wherein the control unit is configured to determine a high-pass characteristic for the adapted performance of the high-pass filtering based (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average; [0065]-[0071]; the time constant tau (high-pass characteristic) is used in the filtering/de-trending to obtain high-frequencies/perform a high-pass filtering operating) on at least one of:
the time course of the respiratory muscle pressure; and a kinetic equation for the breathing circuit of the patient (Mulqueeny: where Pressure = Flow*R + Volume/C + PEEPtot is also used to determine lung mechanics and tau; [0065] and Eger: parameters of tau=R/E is determined using linear regression and lung mechanical equations; [0058]-[0064] and p.sub.mus(t) is determined from measured values of airway pressure, volume flow, and lung parameters E=R/T; claim 1, [0058]-[0064]).
Regarding claim 18, Eger discloses
a process for determining a patient component of a gas exchange of a patient being ventilated (fig. 1; method using a respiration system for proportional assist ventilation with a control unit, EMG electrodes 1, 2 and ventilator 5 to determine a respiratory effort; abstract, [0011], [0040]), the process comprising process steps of:
detecting and determining a time course of a respiratory muscle pressure of the patient based on an electromyographic signal, or a pneumatic signal or a mechanical signal during a patient ventilation (figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t) using the signals determined for the breathing activity u.sub.emg(t), airway pressure and volume flow; claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated);
a t = R/E relationship as a time constant (determining the time constant .tau. during a passive period of the breathing cycle during inspiration or expiration according to E=R/.tau.; [0061], rearranged, tau =R/E), wherein R and E are lung mechanical parameters of the patient being ventilated (lung mechanical parameters resistance (R), elastance (E) of the patient; [0058]-[0064]), wherein R is the resistance (lung mechanical parameter resistance (R); [0058]-[0064]) and E is the elastance of the patient's lung (lung mechanical parameter elastance (E); [0058]-[0064]);
determining the patient component of the airway flow based on the time course of the respiratory muscle pressure during the patient ventilation (determining a respiratory effort pressure p.sub.pat(t) by the control unit as a weighted mean according to p.sub.pat(t)=ap.sub.mus(t)+(1-a)p.sub.emg(t); claim 1 and 37; [0014], [0025]; volume flow of the patient is also correlated with p.sub.mus(t); [0012]).
Eger does not disclose performing an adapted high-pass filtering for the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung; and determining the patient component of the airway flow based on the time course of the filtered respiratory muscle pressure during the patient ventilation
Vicario discloses an analogous respiratory monitory apparatus that determines a respiratory muscle pressure P.sub.mus(t) and comprises
performing a filtering for the time course of the respiratory muscle pressure (fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]); and
determining the patient component of the airway flow based on the time course of the filtered respiratory muscle pressure during the patient ventilation (fig. 14; controller 60 and WOB calculator 44 uses p.sub.mus(t) to compute patient work of breath and power of breath, [0075] and [0085]; and detection processor 40 with classification processor 58 is used to detect abnormalities and asynchronies extracted from the p.sub.mus,surr signal; [0081]-[0083]; fig. 1; signals are analyzed; [0043]-[0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control and analysis unit of Eger with the various processors and controllers as disclosed in Vicario to provide filtering, signal to noise ratio reduction, data smoothing, and identify asynchronies in the filtered muscle pressure p.usb.mus(t) for adjusting ventilation (Vicario: [0076], [0080]-[0085] and [0087]-[0088]).
The modified method of Eger does not explicitly disclose performing an adapted high-pass filtering for the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure, wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung.
Mulqueeny discloses methods and devices for automating detection of asynchrony where
performing an adapted high-pass filtering using a t = R/E relationship as a time constant to obtain a filtered signal (a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating), wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (Tau = R*C. The patient's time constant (Tau) , a respiratory mechanics based feature, may also be determined as the resistance times the compliance; where R is resistance and C is compliance of the respiratory system; [0065]; while this does not explicitly state t=R/E, it would have been readily understood that elastance is the inverse of compliance (C=1/E); therefore, the time constant Tau =R*C is equivalent to tau = R/E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filtering of the muscle pressure p.sub.mus(t) of the modified device of Eger with the filtering technique of Mulqueeny to provide a smoother version of the original signal (Mulqueeny: [0065]-[0071] and [0106]).
It directly follows that the resultant control unit and filtering of the modified device of Eger combined with the filtering technique of Mulqueeny would meet the claimed structural limitations since:
performing an adapted high-pass filtering for the time course of the respiratory muscle pressure using a t = R/E relationship as a time constant to obtain a time course of a filtered respiratory muscle pressure (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average, in other words , subtracting the moving average from the original respiratory signal to obtain the resulting signal; [0065]-[0071]; therefore, the de-trending of the moving average is capable of obtaining high-frequencies/performing a high-pass filtering operating; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]), wherein R and E are lung mechanical parameters of the patient being ventilated, wherein R is the resistance and E is the elastance of the patient's lung (Mulqueeny: Tau = R*C. The patient's time constant (Tau) , a respiratory mechanics based feature, may also be determined as the resistance times the compliance; where R is resistance and C is compliance of the respiratory system; [0065]; while this does not explicitly state t=R/E, it would have been readily understood that elastance is the inverse of compliance (C=1/E); therefore, the time constant Tau =R*C is equivalent to tau = R/E; Eger: determining the time constant .tau. during a passive period of the breathing cycle during inspiration or expiration according to E=R/.tau.; [0061], rearranged, tau =R/E).
Regarding claim 19, the modified method of Eger further discloses
a process (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 18,
wherein a determination of a high-pass characteristic is performed for the adapted performance of the high-pass filtering (Mulqueeny: a segmented moving average filter with the time constant (Tau = R*C) is applied to the signal and is further de-trended by subtraction of the moving average; [0065]-[0071]; the time constant tau (high-pass characteristic) is used in the filtering/de-trending to obtain high-frequencies/perform a high-pass filtering operating) at least one of:
based on the time course of the respiratory muscle pressure; and based on a kinetic equation for the breathing circuit of the patient (Mulqueeny: where Pressure = Flow*R + Volume/C + PEEPtot is also used to determine lung mechanics and tau; [0065] and Eger: parameters of tau=R/E is determined using linear regression and lung mechanical equations; [0058]-[0064] and p.sub.mus(t) is determined from measured values of airway pressure, volume flow, and lung parameters E=R/T; claim 1, [0058]-[0064]).
Regarding claim 20, the modified device of Eger discloses
a process (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) according to claim 19,
While Eger does disclose a control unit (abstract, claim 1, claim 37, [0012]-[0014] and [0064]), it does not explicitly disclose wherein a computer program with a program code performs at least some of the process steps when the program code is executed on a computer, on a processor or on a programmable hardware component.
However, Mulqueeny further discloses
wherein a computer program with a program code performs at least some of the process steps when the program code is executed on a computer, on a processor or on a programmable hardware component (some or all of the processor control instructions and data for controlling may be contained in a computer readable recording medium as software for use by a general purpose computer so that the general purpose computer may serve as a specific purpose computer; and where the computer may be programmed; [00138], [00151], [00165], [00167]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the control unit of Eger to be a programmable computer as disclosed in Mulqueeny to yield the predictable results of being able to implement the algorithms (i.e.. filtering and calculation algorithms) or methodologies (Mulqueeny: [00138], [00151], [00165], [00167]).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Eger (US 20090159082) in view of Vicario (US 20210205558) and further in view of Mulqueeny (WO 2010121313) and Wu (CN 109330569) and its translation (EspaceNet Translation Wu).
Regarding claim 4, the modified device of Eger discloses
a device (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 1,
The modified device of Eger does not explicitly disclose wherein the control unit is configured: to carry out a transformation of the time course of the respiratory muscle pressure into the frequency domain; to carry out the high-pass filtering in the frequency domain in order to obtain a filtered spectrum; and to carry out a transformation of the filtered spectrum into the time domain in order to obtain the time course of the filtered respiratory muscle pressure.
wherein the control unit (main chip; [0026]) is configured:
to carry out a transformation of the signal into the frequency domain (transform the
time-varying resultant acceleration signal to the frequency domain; [0026]);
to carry out the high-pass filtering in the frequency domain in order to obtain a filtered spectrum (the transformed spectrum sequence of different acceleration analog signals can be seen; where the transformed value of the low-frequency band signal is multiplied by a high-pass filter the high frequency band acceleration analog signal [0026]); and
to carry out a transformation of the filtered spectrum into the time domain in order to obtain the time course of the filtered signal (after high-pass filtering, an inverse Fourier transform is performed to obtain the filtered signal in the time domain; [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit and filtration of p.sub.mus(t) of the modified device of Eger with the filtration technique of Wu to transform the time domain signal into the frequency domain, carry out a high-pass filter so that the low-frequency band interference signal is attenuated to zero, thereby filtering out the interference signal and retaining the high frequency
band, and perform the inverse Fourier transform to obtain the filtered time domain signal (Wu: [0026]); therefore, isolating the time domain signal from interference signals.
It directly follows that the resultant control unit of the modified device of Eger combined with the filtration technique of Wu would meet the claimed structural limitations since:
wherein the control unit (Eger: figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated) is configured:
to carry out a transformation of the time course of the respiratory muscle pressure into the frequency domain (Wu: transform the time-varying signal to the frequency domain; [0026]; Eger: respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]);
to carry out the high-pass filtering in the frequency domain in order to obtain a filtered spectrum (Wu: the transformed spectrum sequence of different analog signals can be seen; where the transformed value of the low-frequency band signal is multiplied by a high-pass filter the high frequency band analog signal [0026]); and
to carry out a transformation of the filtered spectrum into the time domain in order to obtain the time course of the filtered respiratory muscle pressure (Wu: after high-pass filtering, an inverse Fourier transform is performed to obtain the filtered signal in the time domain; [0026]; Eger: respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]).
Regarding claim 15, the modified device of Eger discloses
a measuring device or ventilation device system (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 12,
The modified device of Eger does not explicitly disclose wherein the control unit is configured: to carry out a transformation of the time course of the respiratory muscle pressure into the frequency domain; to carry out the high-pass filtering in the frequency domain in order to obtain a filtered spectrum; and to carry out a transformation of the filtered spectrum into the time domain in order to obtain the time course of the filtered respiratory muscle pressure.
wherein the control unit (main chip; [0026]) is configured:
to carry out a transformation of the signal into the frequency domain (transform the
time-varying resultant acceleration signal to the frequency domain; [0026]);
to carry out the high-pass filtering in the frequency domain in order to obtain a filtered spectrum (the transformed spectrum sequence of different acceleration analog signals can be seen; where the transformed value of the low-frequency band signal is multiplied by a high-pass filter the high frequency band acceleration analog signal [0026]); and
to carry out a transformation of the filtered spectrum into the time domain in order to obtain the time course of the filtered signal (after high-pass filtering, an inverse Fourier transform is performed to obtain the filtered signal in the time domain; [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit and filtration of p.sub.mus(t) of the modified device of Eger with the filtration technique of Wu to transform the time domain signal into the frequency domain, carry out a high-pass filter so that the low-frequency band interference signal is attenuated to zero, thereby filtering out the interference signal and retaining the high frequency
band, and perform the inverse Fourier transform to obtain the filtered time domain signal (Wu: [0026]); therefore, isolating the time domain signal from interference signals.
It directly follows that the resultant control unit of the modified device of Eger combined with the filtration technique of Wu would meet the claimed structural limitations since:
wherein the control unit (Eger: figs. 1-10; a control and analysis unit for: determining a respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; where the time curve p.sub.mus(t) can be calculated) is configured:
to carry out a transformation of the time course of the respiratory muscle pressure into the frequency domain (Wu: transform the time-varying signal to the frequency domain; [0026]; Eger: respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]);
to carry out the high-pass filtering in the frequency domain in order to obtain a filtered spectrum (Wu: the transformed spectrum sequence of different analog signals can be seen; where the transformed value of the low-frequency band signal is multiplied by a high-pass filter the high frequency band analog signal [0026]); and
to carry out a transformation of the filtered spectrum into the time domain in order to obtain the time course of the filtered respiratory muscle pressure (Wu: after high-pass filtering, an inverse Fourier transform is performed to obtain the filtered signal in the time domain; [0026]; Eger: respiratory muscle pressure p.sub.mus(t); claim 1, claim 37, [0012]-[0014] and [0064]; Vicario: fig. 14; per-breath P.sub.mus,surr signal is transmitted to the filtering processor 38, where it is filtered; [0080]).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Eger (US 20090159082) in view of Vicario (US 20210205558) and further in view of Mulqueeny (WO 2010121313) and Younes (US 20040050387).
Regarding claim 8, the modified device of Eger discloses
a device (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 1,
The modified device of Eger does not explicitly disclose wherein at least one of: the control unit is configured to determine times at which a breathing effort of the patient ends from the patient component; and the control unit is configured to determine times at which a breathing effort of the patient begins from the patient component.
However, Younes discloses an analogous device for determining muscle pressure and a respiratory time constant t=R/E
wherein at least one of:
the control unit is configured to determine times at which a breathing effort of the patient ends from the patient component (see figs. 3-8b and14a; at 1.0 sec an inspiratory effort begins. P.sub.mus rises at a rate of 10 cmH.sub.2O/sec, representative of a normal respiratory drive; [0012], where T.sub.onset identification circuit 32 detects the onset of the inspiratory effort [0165] and times where T.sub.onset are recorded; [0204]); and
the control unit is configured to determine times at which a breathing effort of the patient begins from the patient component (see figs. 3-8b and14a; a reasonable approximation of the shape of inspiratory muscle output (P.sub.mus) (for example, see FIG. 6). End of inspiratory effort (T.sub.end) is normally defined as the point at which inspiratory muscle output rapidly declines from its peak value; [0146], where T.sub.end identification circuit 33 is used to detect the end of inspiratory effort [0165] and times where T.sub.end are recorded; [0204]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control means of the modified device of Eger with the inspiratory onset and ends identification circuit of Younes to determine non-invasively, the true onset (T.sub.onset) and end (T.sub.end) of patient's inspiratory effort which can be used to monitor/inform the user of the presence and magnitude of trigger delays, ineffective efforts and cycling-off errors; take appropriate action to reduce the non-synchrony; and adjust ventilation cycles such that onset and end of ventilator cycles are automatically linked to onset and end of patient's efforts, thereby insuring synchrony without intervention by the user (Younes: [0034] and [0105]).
Regarding claim 10, the modified device of Eger discloses
a device (Eger: respiration system for proportional assist ventilation; Vicario: filtering of p.sub.mus (t); Mulqueeny: filtering technique using t=R/E to provide a high-pass filtering operation) in accordance with claim 1,
The modified device of Eger does not explicitly disclose wherein the control unit is configured to determine a spontaneous respiration rate of the patient from the patient component.
However, Younes discloses an analogous device for determining muscle pressure and a respiratory time constant t=R/E
wherein the control unit is configured to determine a spontaneous respiration rate of the patient from the patient component (see figs. 3-9 and14a; microprocessor uses "calculate patient rate function" (83, FIG. 9) calculates respiratory rate of patient 83 from the sum of number of T.sub.onset transitions during expiration 50 in the last minute and the number of additional efforts during inflation 82 in the last minute; [0188]; where t.sub.onset and t.sub.end are determined from the users muscle pressure using T.sub.onset identification circuit 32 and T.sub.end identification circuit 33; [0012], [0146], [0165], and [204]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control means of the modified device of Eger with the inspiratory onset and ends identification circuits and calculate patient function of Younes to determine non-invasively, the true onset (T.sub.onset), true end (T.sub.end) of patient's inspiratory effort and the patients respiratory rate which can be used to monitor/inform the user of the presence and magnitude of trigger delays, ineffective efforts and cycling-off errors; take appropriate action to reduce the non-synchrony; calculate the desirable duration of the ventilator; and adjust ventilation cycles such that onset and end of ventilator cycles are automatically linked to onset and end of patient's efforts, thereby insuring synchrony without intervention by the user (Younes: [0034], [0105], [0188]-[0189]).
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 1-8 and 10-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang (US 20180317808) – discloses respiratory monitory which uses an equation of motion of the lungs relating airway pressure and airway flow to generate asynchronously estimated respiratory parameters for the breath interval; estimates the respiratory muscle pressure (P.sub.mus(t)) parameter via a P.sub.mus(t) estimator 56; calculates the pob from an estimate of p.sub.mus(t); uses equation of motion of the lungs
Banner (US 6390091) – discloses parameters and data derived from sensors such as the determined respiratory muscle pressure (Pmus(t)), the determined tidal volume, the work of breathing of the patient, etc.
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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