DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to an amendment filed on 10/30/2025. As directed by the amendment, no claims were canceled, claims 15-16 were amended, and no new claims were added. Thus, claims 1-20 are pending for this application, with claims 15-20 under examination and claims 1-14 withdrawn from consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15, the phrase “a corresponding ventilator” in line 6-7 is unclear whether “ventilator” refers to the “mechanical ventilator” in line 2 of claim 15 or a “ventilator” of the “fleet of ventilators” in line 2 of claim 15.
Regarding claim 15, the phrase “receiving sensed outputs” in line 9 is unclear as no structure has been recited for performing this sensing function (no sensors have been claimed), therefore the metes and bounds of the claim is unclear.
Regarding claim 15, the phrase “a ventilator supervisory control system running in real-time on a system” in line 14 is unclear whether “system” is in reference to the “system” of line 1 claim 15 or whether “system” is referencing a new system entirely.
Claim 15 recites the limitation "the output of the predictor-corrector" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the bias accumulation classified by ambient conditions or utilization" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected due to dependence on a rejected base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capelli (US 2015/0165140) in view of Fox (US 2023/0191063), Cipollone (US 2022/0148701), Schwaibold (US 2020/0053086) and Khachaturian (US 2019/0046056).
Regarding claim 15, as best understood, Cappelli discloses (Fig. 1-13) a system, comprising:
a mechanical ventilator (flow generator 102);
a ventilator model (pressure estimation unit 406, paragraph [0119]-[0120]) running in real-time on a processor (processor 116, paragraph [0057]));
a predictor-corrector (pressure validation unit 408) running in real-time on the processor (paragraph [0057]) receiving sensed outputs of the mechanical ventilator and an output of the ventilator model (receives outputs of pressure sensor and output of pressure estimation unit 406, see paragraph [0138]);
a GUI (display, not shown but in the form of a monitor or LCD panel) generating a display, the display based on an output of the predictor-corrector (displays status or warning message concerning determined faults of system, paragraph [0056] and [0184]);
a ventilator supervisory control system (fault handler 122) running in real-time on a system, the ventilator supervisory control system receiving the output of the predictor-corrector (“the pressure validation unit 408 may output a signal indicating that the pressure sensor 104 is inaccurate to the pressure sensor fault handler 122 for further execution”, paragraph [0139]), the ventilator supervisory control system communicating with the mechanical ventilator (adjusts operation of the mechanical ventilator, paragraph [0185]).
Capelli discloses the ventilatory control system may be remote from the ventilator and may communicate via a network, but does not disclose explicitly disclose an edge processor; wherein the ventilator supervisory control system communicating with the edge processor, the edge processor further communicating with the ventilator model and a cloud network.
However, Fox teaches (Fig. 1) a system comprising an edge processor (remote or local server that performs edge cloud processing, paragraph [0090]), and a ventilatory control system (control system 110 for ventilator 122) system communicating with the edge processor (paragraph [0090]), the edge processor further communicating with the ventilator model (processing mechanisms that receive and calculate data from ventilator sensors, paragraphs [0146]-[0148]) and a cloud network (cloud processing and therefore a cloud network, paragraph [0090]).
Therefore, 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 system of Capelli to include, an edge processor; wherein the ventilator supervisory control system communicating with the edge processor, the edge processor further communicating with the ventilator model and a cloud network, as taught by Fox, for the purpose of allowing the calculations to performed remote from the ventilator, thereby reducing the computing power required by the ventilator.
Modified Capelli discloses a single ventilator and discloses an edge processor that communicates over a cloud network (paragraph [0090 Fox), but does not disclose a fleet of ventilators comprising the mechanical ventilator; a cloud network comprising a plurality of fleet models for measuring conditions of the fleet of ventilators, wherein each of the plurality of fleet models is differentiated based on a closeness to triggering a fault.
However, Cipollone teaches (Fig. 1-8) a system comprising a fleet of ventilators (plurality of ventilators, paragraph [0031]) comprising the mechanical ventilator (the mechanical ventilator 200, used by the patient); a cloud network (“cloud platform”, paragraph [0031], that is connected to the server 150, paragraph [0031-[0032]]) comprising a plurality of fleet models (patient treatment data for the plurality of ventilators, which include a patient identifier (e.g., a unique alpha-numeric code that is HIPAA compliant for use with Electronic Medical Records), age, height, weight, sex, diagnosis, test results, condition, medical history, manufacturer, make, model, serial number, parts list, features list, location (e.g., GPS location of the ventilator), battery status, media bed status, environmental conditions, usage data (e.g., usage data associated with various therapy modules), trend data, event data, alarm data, compliance data, diagnostic data, or the like. See paragraph [0032]) for measuring conditions of the fleet of ventilators (i.e. location (e.g., GPS location of the ventilator), battery status, media bed status, environmental condition, usage data, event data, alarm data, compliance data, etc., paragraph [0032]), wherein each of the plurality of fleet models is differentiated based on a closeness to triggering a fault (each fleet model, which corresponds to data for a different ventilator, includes alarm data which indicates closeness to an alarm condition or even if an alarm condition was reached, paragraph [0032] and [0058]).
Therefore, 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 system of modified Capelli to include a fleet of ventilators comprising the mechanical ventilator; a cloud network comprising a plurality of fleet models for measuring conditions of the fleet of ventilators, wherein each of the plurality of fleet models is differentiated based on a closeness to triggering a fault, as taught by Cipollone, for the purpose of optimizing settings for a given user based on a plurality of conditions, including operation of similar and different models, and other information so that user experience can be improved.
Modified Capelli discloses clinician adjusts operation of the mechanical ventilator based on communication with the cloud network providing feedback related to other mechanical ventilators in a same fleet model of the plurality of fleet models with the mechanical ventilator (paragraphs [0047] and [0067]), and thus does not disclose the edge processor is responsible for adjusting operation of the mechanical ventilator.
However, Schwaibold teaches (Fig. 1-3) a system for adjusting operation of a mechanical ventilator wherein an edge processor (“server”, paragraph [0137]) is responsible for adjusting operation of the mechanical ventilator (settings of the mechanical verntilator provides adjusted appropriate settings for operation of the mechanical ventilator based on data collected which are specific to the specific mechanical ventilator model and previous data obtained form said model, see paragraphs [0137] and [0159]).
Therefore, 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 system of modified Capelli such that the operation adjustment of the ventilator is performed by the edge processor, as taught by Schwaibold, for the purpose of allowing for safe and accurate adjustment of the device to fit the needs of the user and specific specifications of the ventilator without requiring a clinician to be present.
Modified Capelli does not disclose each of the plurality of fleet models is configured to differentiate bias accumulation due to ambient conditions of a corresponding ventilator or utilization.
However, Khachaturian teaches (Fig. 21) a system comprising a model (estimator 2118) configured to differentiate bias accumulation due to ambient conditions (memory stores a bias representation and a calibration difference in consideration of temperature sensing mode in order to estimate actual temperature and thus provides for differentiation of bias accumulation (the accumulation being the bias and calibration differences stored in memory that are differentiated in order to perform the calculations), paragraph [0364]). It should be noted that while Khachaturian does not disclose this function is performed for a ventilator, the primary reference Cappelli already discloses the function of determining gas temperature for a ventilator using temperature measurement of ambient air temperature (paragraph [0053] Capelli), and thus one of ordinary skill would have found it obvious to incorporate the teaching of Khachaturian into the modified Capelli reference for the purpose of providing a more accurate temperature measurement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the fleet models of modified Capelli to be configured to differentiate bias accumulation due to ambient conditions of a corresponding ventilator or utilization, as taught by Khachaturian, for the purpose of providing a more accurate temperature measurement, thereby improving accuracy and functionality of the system.
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capelli (US 2015/0165140) in view of Fox (US 2023/0191063), Cipollone (US 2022/0148701), Schwaibold (US 2020/0053086), and Khachaturian (US 2019/0046056), as applied to claim 15, and further in view of Sanson (US 2022/0323711) and McCormick (US 2008/0295837).
Regarding claim 16, as best understood, modified Capelli discloses wherein the mechanical ventilator includes a state machine (programmable instructions/algorithms in memory of the apparatus, paragraph [0060]) controlling operation of the mechanical ventilator, the state machine including: a normal operation state (state when no faults have been detected) and a pressure bias state (“safe mode”, when a fault is detected so device is adjusted but still operable, paragraph [0185]).
Modified Capelli discloses the ventilator provides oxygen to a user (Capelli discloses in paragraph [0003] that a function of a ventilator is to provide oxygen to a user and move carbon dioxide from a user), but does not disclose the state machine includes an oxygen estimation state and oxygen backup state.
However, Sanson teaches (Fig. 1-8) a system for providing air to a user comprising a state machine (“closed loop control system”, paragraph [1035]) controlling operation of a mechanical ventilator including states of: oxygen estimation state (determines fed oxygen levels of a user and compares level to target level, paragraphs [1048]-[1049]) and oxygen backup state (issues an alarm if oxygen, paragraph [0400], is above or below threshold concentration, paragraph [0430]-[0431]).
Therefore, 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 system of modified Capelli to include an oxygen estimation state and oxygen backup state, as taught by Sanson, for the purpose of preventing damage to a user by regulating the amount of oxygen provided.
Modified Capelli discloses a flow sensor (106) to detect flow attributable to mask leak (paragraph [0051] Capelli) but does not disclose the state machine includes a gas leak state.
However, McCormick teaches (Fig. 1-3) a state machine (software of CPU 26) that includes a gas leak state (determines whether a gas leak occurs if and if it does it adjust operation to prevent injury to user, paragraphs [0031] and [0035]).
Therefore, 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 system of modified Capelli to include a gas leak state, as taught by McCormick, for the purpose of preventing volume trauma to a user that would otherwise occur if a user receives the compensated amount of oxygen (paragraph [0031] and [0035] McCormick).
Regarding the limitation “the bias accumulation classified by ambient conditions or utilization is deployed to the edge processor for adapting the ventilator model”, modified Capelli already discloses that the edge processor performs adjustment of the ventilator model based on specific mechanical ventilator data collection (paragraphs [0137] and [0159] Schwaibold), therefore one of ordinary skill in the art would recognize it would have also been obvious for bias accumulation to also be deployed to adapt the ventilator model because it is already disclosed by Khachaturian that bias accumulation differentiation is useful for accurately estimating a temperature (paragraph [0364] Khachaturian), and off-loading this adjustment to the edge processor would reduce the computing power requirements of the ventilator device.
Regarding claim 17, modified Capelli discloses wherein a transition from the normal operation state to the pressure bias state is determined based on detection of a pressure bias by the system (see Capelli paragraph 185).
Regarding claim 18, modified Capelli discloses wherein a transition from the normal operation state to the oxygen estimation state is determined based on detection of an oxygen bias by the system (paragraph [1048]-[1049] Sanson).
Regarding claim 19, modified Capelli discloses wherein a transition from the oxygen estimation state to the oxygen backup state is determined based on detection of an oxygen bias outside a first threshold (paragraphs [0430]-[0431] Sanson).
Regarding claim 20, modified Capelli discloses wherein a transition from the normal operation state to the gas leak state is determined based on a detection of a gas leak by the system (paragraphs [0031] and [0035[ McCormick).
Response to Arguments
Applicant’s arguments filed 10/30/2025 have been fully considered.
Applicant’s arguments with respect to claim(s) 15 have been considered but are moot because the new ground of rejection relies on one or more new references not applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the Schwaibold reference, applicant argued (page 9 paragraph 2 Remarks) that the Schwaibold reference does not disclose an edge processor and disagrees that the examiner’s assertion that the “server” of Schwaibold is similar to an edge processor, as the server of Schwaibold is a centralized remote system that cannot communicate over cloud network.
Examiner respectfully disagrees.
First, Applicant is reminded that the teaching of an “edge processor” is taught by the Fox reference, not Schwaibold. Thus, applicant’s argument that Schwaibold does not teach this feature is moot.
Furthermore, the server of Schwaibold is similar in functionally to an edge processor because it does have cloud communication, as recited in paragraph [0107] of Schwaibold.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785