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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 10/06/2025 has been entered.
Claims Pending
Applicant’s cancellation of claims 4, 7, and 16 in the response filed 10/06/2025 is acknowledged.
Claims 1-3, 5-6, 8-15, and 17-20 are the current claims hereby under examination.
Claim Objections
Claim 6 objected to because of the following informalities:
In claim 6, “further and configured for” (line 2), should read -further configured for-
Appropriate correction is required.
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 1-3, 5-6, 8-15, and 17-20 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.
Claim 1 recites the limitation “the evaluation device is further configured to determine the at least one characteristic number during ventilation and for continuously updating the at least one characteristic number at defined time intervals, such that the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods”, which fails to effectively define the metes and bounds of the claim as it is unclear how the characteristic number is calculated. Claim 1 also recites “evaluation device being configured for calculating, from a time profile of the at least two respiration parameters, at least one stability rate and for determining from the at least one stability rate at least one characteristic number for a respiration stability of the patient”, which presents the characteristic number as being from the stability rate. However, this appears to contradict the indicated limitation of the claim that recites “the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods”. How is the characteristic number taking account for values of past characteristic numbers when the previous limitation did not involve using the characteristic number for the calculation of the characteristic number? The applicant’s specification indicates “For example, a characteristic number that indicates low stability can, after quite a long phase of good respiration stability, assume a value that takes account of the improved respiration stability. In particular, the updated characteristic number is averaged from previous characteristic numbers and/or is derived statistically in another way.” (Page 7, line 1-6 of applicant’s spec.), which indicates that the characteristic number is calculated by an average of previous numbers or derived statistically. The applicant’s specification further indicates which indicates that the characteristic number can be determined from a trend of a characteristic value of a respiration parameter and the characteristic value can be determined from a statistical variation for respiration parameter values (Page 7, lines 17-32 of applicant’s spec.). The applicant’s specification further states “such that the characteristic number takes at least partial account of past time periods and of the values assigned to these time periods for the characteristic number” (Page 23, claim 7 of applicant’s spec.), which indicates that the updating takes partial account of values assigned to the time periods for the characteristic number. The above limitation states “the evaluation device is further configured to determine the at least one characteristic number during ventilation and for continuously updating the at least one characteristic number at defined time intervals”, which indicates that this is the same characteristic number and that evaluation device is configured to determine the characteristic number in this manner. Since this is the same characteristic number, and both are occurring during ventilation, how is there a different determination made that results in the same output? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, “such that the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods” will be interpreted as -such that the characteristic number takes at least partial account of past time periods and of the values assigned to these time periods for the characteristic number- (Page 23, claim 7 of applicant’s spec.).
Claim 8 recites the limitation “respiration parameter” in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -respiration parameters-.
Claim 9 recites the limitation “respiration parameter” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -respiration parameters-.
Claims 2-3, 5-6, 8-15, and 17-20 are dependent on claim 1, and as such are also rejected. For examination purposes, these claims will be examined under the same limitations of the claim they are dependent on.
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.
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 1-3, 5-6, 8-15, and 18-20 are rejected under 35 USC 101 because the claimed invention is directed towards a judicial exception without significantly more. These claims do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception
Step 1 of the subject matter eligibility test
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter.
Step 2A of the subject matter eligibility test
Prong One: Claim 1 recites the abstract idea of a mental process as follows:
“recording, over time, at least two different respiration parameters selected from respiratory rate, tidal volume, respiratory gas flow and respiratory gas pressure detected”, “calculating, from a time profile of the at least two respiration parameters, at least one stability rate and for determining from the at least one stability rate at least one characteristic number for a respiration stability of the patient, such that the at least one characteristic number provides an assessment of a quality of the ventilation during a period of time”, “determine the at least one characteristic number during ventilation and for continuously updating the at least one characteristic number at defined time intervals, such that the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods”.
The recording, over time, at least two different respiration parameters selected from respiratory rate, tidal volume, respiratory gas flow and respiratory gas pressure detected, calculating, from a time profile of the at least two respiration parameters, at least one stability rate and for determining from the at least one stability rate at least one characteristic number for a respiration stability of the patient, such that the at least one characteristic number provides an assessment of a quality of the ventilation during a period of time, and determining the at least one characteristic number during ventilation and for continuously updating the at least one characteristic number at defined time intervals, such that the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods can be practically performed by the human mind, with the aid of a pen and paper, but for performance on a generic processor, in a computer environment, or merely using the computer as a tool to perform the steps.
A person of ordinary skill in the art could reasonably calculate a time profile and determine a respiration stability parameter with a generic computer based upon the receipt of respiration data. A person of ordinary skill in the art could reasonably record two different respiration parameters with a pencil and paper or using a generic computer based on being handed a piece of paper with respiration data. A person of ordinary skill in the art could reasonably determine at least one characteristic number and continuously update the number with a generic computer or a pen and paper based on having past respiration data and current respiration data.
There is currently nothing to suggest an undue level of complexity in the calculating, recording, or determining. Therefore, a person would be able to practically be able to perform the calculating and determining steps mentally or with the aid of pen and paper.
Prong Two: Claim 1 does not recite additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., a computer), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “at least one sensor” and “a ventilator”).
The additional elements merely serve to gather data to be used by the abstract idea. The sensor and ventilator are merely used as a pre-solution step of necessary data gathering to be used by the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing that is performed remains in the abstract realm, i.e. the gathered data is not used for a treatment or meaningful purpose. Additionally, there is no overall improvement to existing technology present. The mental process merely functions on generic computer elements that do not change the functionality of the computer unit itself. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
a ventilator as disclosed by Bennarsten (US Pat. No. US 6694978) hereinafter Bennarsten “HFO ventilators are well known and generally have an oscillator which is connectable in gas communication with one end of the gas tubing of a patient circuit.” (Col. 1, lines 24-26) and Acker (US Pub. No. 20070125380) hereinafter Acker “many types of mechanical ventilators are well-known, and they can be generally classified into one (1) of three (3) broad categories: spontaneous, assisted, and/or controlled mechanical ventilators.” (Par. 8),
a sensor as disclosed by Misholi (US Pub. No. 20040016302) hereinafter Misholi “It will be well known to those familiar with the art that many mechanical ventilators utilize a flow sensor fashioned in the form of a bore of cylindrical tubing containing within it a strut, also known as an interfering body, in a manner which facilitates differential pressure measurements, at either end of the strut, that are proportional to the flow rate of the respiratory gases that pass through the sensor. Such a flow sensor is hereinafter referred to as a differential-pressure flow sensor, and is described in more detail below” (Par. 3) and Daniels (US Pat. No. 6099481) hereinafter Daniels “Sensors that are capable of measuring the partial pressure of carbon dioxide content in a patient's breath are well known. The currently preferred device for measuring breath carbon dioxide content is a gas analyzer of the type employing non-dispersive infrared radiation which presents data representing the %CO.sub.2 (or pCO.sub.2) of a sample of exhaled breath.” (Col. 3, lines 58-64).
Claims 2-3, 5-6, 8-15, and 18-20 not include additional elements, alone or in combination that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) as all of the elements are directed to the further describing of the abstract idea, pre-solution activities, computer implementation, generic post-solution activities.
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely Further describe the abstract idea:
outputting the at least one characteristic number as at least one number and/or graph and/or at least one symbol and/or word (Claim 2) (Examiner's Note: A person of ordinary skill in the art could reasonably output a number with a generic computer or verbally),
the determined characteristic number corresponds to at least one value on a scale, one end of the scale being assigned a higher or maximum respiration stability and another end of the scale being assigned a lower or minimum respiration stability (Claim 3),
outputting the value and/or the scale with the at least one value positioned thereon (Claim 3),
Assigning, to a time period in which a stability rate exceeds a threshold value for the stability, a characteristic number with a value provided for a maximum respiration stability and/or for assigning, to a time period in which the stability rate exceeds a threshold value for the instability, a characteristic number with a value provided for a minimum respiration stability (Claim 5) (Examiner's Note: A person of ordinary skill in the art could reasonably assign a characteristic number with values provided for respiration stability with a generic computer, mentally, or with a pen and paper),
Assigning, to a time period in which the stability rate lies between a threshold value for the stability and a threshold value for the instability, a characteristic number with one value (Claim 6),
Calculating the value from the stability rate by at least one assignment function (Claim 6),
Determining the at least one characteristic number using at least one statistical characteristic value for a trend of a time profile of the respiration parameter (Claim 8),
Determining the at least one characteristic number at least from at least one statistical variation measure for a distribution of values in a time profile of the respiration parameter (Claim 9),
Calculating and outputting a trend for a past and/or future development of the at least one characteristic number (Claim 10),
wherein the at least two different respiration parameters used for determining the at least one characteristic number are selected from respiratory rate, respiratory gas flow, and respiratory gas pressure (Claim 11),
Changing the at least one characteristic number in a direction of poor respiration stability (Claim 12),
executing at least one action if the at least one characteristic number lies in at least one defined critical value range for a respiration stability and/or has a trend toward this, and wherein the action comprises an output of at least one warning and/or alarm and/or an action description (Claim 13) (Examiner's Note: A person of ordinary skill in the art could verbally provide an alarm based on being handed a piece of paper with respiration data),
wherein at least one critical value range is provided for too high a respiration stability and at least one critical value range is provided for too low a respiration stability (Claim 14),
wherein the evaluation device is further configured for outputting the at least one characteristic number in combination with at least one value for at least one respiration parameter (Claim 15),
outputting the at least one characteristic number only after a defined minimum duration of the ventilation and/or for taking account of an action (Claim 18),
outputting the at least one characteristic number together with at least one warning as regards undershooting of a minimum duration and/or together with at least one warning as regards undershooting of the minimum duration for an action, the minimum duration comprising at least two hours and/or at least one night sleep phase of the patient (Claim 18),
Detecting an acute exacerbation if the characteristic number indicates a rise of a respiration stability of the patient (Claim 19).
Further describe the pre-solution activity (or structure used for such activity):
ventilator (Claim 20).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
A ventilator as indicated by Bennarsten and Acker above
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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 claims are generally directed towards an evaluation system that includes an evaluation device that measures respiratory stability over a period of time. Wherein said evaluation device contains a sensor that measures different respiratory values over time, analyzes those values, and the evaluation device uses those respiratory values to determine a characteristic number that is representative of the respiratory stability.
Claims 1-3, 8-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (US Pub. No. 20140330155) hereinafter Brewer, and further in view of Freeman (US Pub. No. 20200383647) hereinafter Freeman.
Regarding claim 1, Brewer discloses An evaluation system for at least one ventilator provided for machine ventilation of a patient (Par. 5 (a system configured to monitor respiration of a subject with sensors and a processor)), wherein the evaluation system comprises at least one evaluation device which is configured for recording (Fig. 1, Par. 14, (system – 10 with processor -24)) (Par. 21, 22, (processor – 24 executes software)), over time, at least two different respiration parameters selected from respiratory rate (Par. 28 (respiratory rate monitor - 40)) (Par. 25 (breathing parameter module – 36)), tidal volume (Par. 32, (tidal volume monitor module - 64)), respiratory gas flow and respiratory gas pressure (Par. 24, “Gas parameter module 34 is configured to determine one or more gas parameters of the flow of breathable gas within subject interface 26 based on the output signals generated by gas parameter sensors 20. The one or more gas parameters may include, for example, one or more of a pressure, a flow rate, a volume, a composition or concentration…”) (Par. 25 (breathing parameter module – 25)) detected by at least one sensor (Par. 24 (from gas parameter sensor)) (Par. 35 (ventilation index module – 35)),
the evaluation device (Par. 22, 35, processor – 24, Ventilation index module - 50) being configured for calculating, from a time profile of the at least two respiration parameters, at least one characteristic number for a respiration stability of the patient (Par. 22, 35, Ventilation index module - 50) (Par. 35 “The ventilation index represents the respiratory stability and/or effectiveness of subject 12. Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics…”),
such that the at least one characteristic number provides an assessment of a quality of the ventilation during a period of time (Par. 35, (ventilation index module – 50) (“Ventilation index module 50 is configured to determine a ventilation index for the subject in an ongoing manner. The ventilation index represents the respiratory stability and/or effectiveness of subject 12. Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics…” “… ventilation index may be a score, an amount of time, a condition rating (e.g., red-yellow-green, good-medium-bad, and/or other rating systems), and/or other indices”)), and
wherein the evaluation device is further configured to determine the at least one characteristic number during ventilation (Par. 35, “Ventilation index module 50 is configured to determine a ventilation index for the subject in an ongoing manner. The ventilation index represents the respiratory stability and/or effectiveness of subject 12. Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics…”) (Par. 5, 14 (monitoring respiration)) (Par. 24, “Gas parameter module 34 is configured to determine one or more gas parameters…” “…The "ongoing" determination of a gas parameter (and/or other parameters, indices, metrics, scores, etc.) may refer to individual determinations of the gas parameter at different times as time goes on. The different times may be determined, for example, by a sampling rate.”) and for continuously updating the at least one characteristic number at defined time intervals (Par. 35, “Ventilation index module 50 is configured to determine a ventilation index for the subject in an ongoing manner…”) (Par. 24, “Gas parameter module 34 is configured to determine one or more gas parameters…” “…The "ongoing" determination of a gas parameter (and/or other parameters, indices, metrics, scores, etc.) may refer to individual determinations of the gas parameter at different times as time goes on. The different times may be determined, for example, by a sampling rate.”) (Par. 31, “end tidal carbon dioxide metric is determined in an ongoing manner (e.g., on a per-breath basis) based on a moving window…” “…The length of time that corresponds to the moving window may be a configurable setting (e.g., by a caregiver), or may be pre-defined without the possibility of customization. The length of time may be the same (or different) as corresponds to the length of time for the moving window implemented by respiratory rate monitor module 40.”) (Par. 28, “respiratory rate monitor module 40 is configured such that the rate metric is determined in an ongoing manner (e.g., on a per-breath basis) based on a moving window within which the average and standard deviation of breath time are calculated for a set of breaths of subject 12 taken within the moving window of time…”) (Par. 35 (tidal volume window of time)).
Brewer highly suggests but fails to explicitly disclose the “characteristic number” that is claimed by the applicant.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention that the ventilation index that represents the respiratory stability (Par. 35) in Brewer reads on the “characteristic number” that is for the respiration stability in the claim.
Brewer fails to explicitly disclose calculating at least one stability rate and for determining from the at least one stability rate at least one characteristic number. (Examiner's Note: Brewer fails to explicitly disclose a separate characteristic number determined from the stability rate).
However, Brewer does disclose a ventilation index based upon a rate metric, the ventilation index that represents the respiration stability at a given time and is calculated in an ongoing manner (Par. 5) (Par. 35).
Freeman teaches calculating at least one stability rate and for determining from the at least one stability rate at least one characteristic number (Par. 239, “… In one embodiment, the pattern analysis includes a combination of parameters which could include any or all of the following: respiratory rate, minute ventilation, tidal volume, slope of inspiration, slope of expiration, respiratory variability. In one embodiment, these parameters are used within the calculation of a Respiratory Health Index (RHI) that provides a standardized quantitative measure of adequacy of ventilation.”).
Brewer and Freeman are considered to be analogous art to the claimed invention as they are involved with the measurement of respiratory parameters.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Brewer with that of Freeman to explicitly include calculating at least one stability rate and for determining from the at least one stability rate at least one characteristic number through the combination of references as differing inputs known for calculating respiratory indices (Freeman (Par. 239)) and it would have yielded the same or similar result of determining respiratory stability (Brewer (Par. 35)).
Modified Brewer highly suggests fails to explicitly disclose such that the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods. (Examiner's Note: Brewer fails to explicitly disclose taking partial account of past characteristic number values) (Examiner's Note: Interpreted under 112(b) as indicated above)
However, Brewer does teach such that the at least one characteristic number takes at least partial account of past time periods (Par. 33, (tidal volume metric based on historical data)) (Par. 31 (end tidal carbon dioxide metric based on historical data)) (Par. 28 (rate metric based on historical data)) (Par. 35, “Ventilation index module 50 is configured to determine a ventilation index for the subject in an ongoing manner. The ventilation index represents the respiratory stability and/or effectiveness of subject 12. Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics…” (the ongoing ventilation index is determined based on the indicated metrics, which involve historical data)) and of values for the at least one characteristic number assigned to these time periods (Par. 33, (tidal volume metric based on historical data)) (Par. 31 (end tidal carbon dioxide metric based on historical data)) (Par. 28 (rate metric based on historical data)) (Par. 35, “Ventilation index module 50 is configured to determine a ventilation index for the subject in an ongoing manner. The ventilation index represents the respiratory stability and/or effectiveness of subject 12. Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics…” (the ongoing ventilation index is determined based on the indicated metrics, which involve historical data)).
Brewer does teach using historical data for improving respiration stability measurements (Par. 4).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Brewer and Freeman with that of Brewer to include such that the at least one characteristic number takes at least partial account of past time periods and of values for the at least one characteristic number assigned to these time periods as using historical data is a known improvement for respiration stability measurements (Brewer (Par. 4)) and it would have yielded the predictable result of improving measurement quality (Brewer (Par. 4)).
Regarding claim 2, modified Brewer further discloses wherein the evaluation device is further configured for outputting the at least one characteristic number as at least one number and/or graph and/or at least one symbol and/or word (Brewer (Par. 35)).
Regarding claim 3, modified Brewer discloses the determined characteristic number corresponds to at least one value on a scale (Par. 35, “The ventilation index may be a score, an amount of time, a condition rating (e.g., red-yellow-green, good-medium-bad, and/or other rating systems), and/or other indices.”).
Modified Brewer highly suggests but fails to explicitly disclose one end of the scale being assigned a higher or maximum respiration stability and another end of the scale being assigned a lower or minimum respiration stability, and wherein the evaluation device is further configured for outputting the value and/or the scale with the at least one value positioned there.
Brewer does disclose a ventilation index that is classified among three condition ratings that make up a scale (Par. 35, “The ventilation index may be a score, an amount of time, a condition rating (e.g., red-yellow-green, good-medium-bad, and/or other rating systems), and/or other indices.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Brewer and Freeman with that of Brewer to include one end of the scale being assigned a higher or maximum respiration stability and another end of the scale being assigned a lower or minimum respiration stability, and wherein the evaluation device is further configured for outputting the value and/or the scale with the at least one value positioned there, where the higher stability is the green value and the lower stability is the yellow value of Brewer as differing data comparison methods are known in the art (Brewer (Par. 35)) and it would have yielded the predictable result of organizing the data output the data.
Regarding claim 8, modified Brewer further discloses wherein the evaluation device is further configured for determining the at least one characteristic number using at least one statistical characteristic value for a trend of a time profile of the respiration parameter (Brewer (Par. 28 (moving average for respiratory rate)) (Par. 31 (moving average for end tidal carbon dioxide)) (Par. 33 (moving average for tidal volume)) (Par. 35, “Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics.)).
Regarding claim 9, modified Brewer further discloses wherein the evaluation device is further configured for determining the at least one characteristic number at least from at least one statistical variation measure for a distribution of values in a time profile of the respiration parameter (Brewer (Par. 28 (standard deviation for respiratory rate)) (Par. 31 (standard deviation for end tidal carbon dioxide)) (Par. 33 (standard deviation for tidal volume)) (Par. 35, “Ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics.)).
Regarding claim 10, modified Brewer further discloses wherein the evaluation device is further configured for calculating and outputting a trend for a past and/or future development of the at least one characteristic number (Brewer (Par. 35 (a ventilation index module with the output based on a tidal volume metric and/or additional metrics) (Par. 33 (the tidal volume analysis is done using historical data to form thresholds)) (Par. 36 (alarm module generates alarms based on ventilation indexes with a threshold and previously gathered data))).
Regarding claim 11, modified Brewer further discloses wherein the at least two different respiration parameters used for determining the at least one characteristic number are selected from respiratory rate, respiratory gas flow, and respiratory gas pressure (Brewer (Par. 35, “ventilation index module 50 is configured to determine the ventilation index based on one or more of the rate metric, the apnea metric, the end tidal carbon dioxide metric, the tidal volume metric, and/or one or more of the other metrics”) (Par. 29, “This may include determining the apnea metric based on one or more of the gas parameters determined by gas parameter module 34 (e.g., pressure and/or flow of the flow of breathable gas”) (Par. 25, “breathing parameters determined by breathing parameter module 36 may include one or more of a respiratory rate, a breath time, an inhalation time, an exhalation time, end-exhalation pause time, end tidal carbon dioxide (e.g., amount, partial pressure, etc.), a inspiratory tidal volume, a expiratory tidal volume, carbon dioxide volume excretion, and/or other breathing parameters.”)).
Regarding claim 12, modified Brewer further discloses wherein the evaluation device is further configured for changing the at least one characteristic number in a direction of poor respiration stability based on at least one of the following causes (Brewer (Par. 35 (ventilation index that represents respiratory stability)) (Par. 36 (an alarm generated based on the ventilation index, and specifically if there is instability in the respiration of the subject))): asynchrony between ventilator and patient; occurrence of partial or complete intermittent airway obstructions; insomnia; problems caused by mask and/or therapy pressure; apnea (Brewer (Par. 35 (apnea metric)) (Par. 36 (alarm generation in cases of respiratory instability))); strong formation of secretion; coughing; unstable respiratory drive; periodic breathing; strong leakages.
Regarding claim 13, modified Brewer further discloses wherein the evaluation device is further configured for executing at least one action if the at least one characteristic number lies in at least one defined critical value range for a respiration stability and/or has a trend toward this (Brewer (Par. 35 (the ventilation index that represents the respiratory stability)) (Par. 36 (alarm module that has specific thresholds for the ventilation index))), and wherein the action comprises an output of at least one warning and/or alarm and/or an action description (Brewer (Par. 36 (if the ventilation index crosses a specific threshold, an alarm is generated))).
Regarding claim 14, modified Brewer further discloses wherein at least one critical value range is provided for too high a respiration stability and at least one critical value range is provided for too low a respiration stability, such that breathing that is too rigid can also lead to an action (Brewer (Par. 35 (the ventilation index that represents the respiratory stability)) (Par. 36 (alarm module that has specific thresholds for the ventilation index)) (Par. 36 (if the ventilation index crosses a specific threshold, an alarm is generated))).
Regarding claim 15, modified Brewer further discloses wherein the evaluation device is further configured for outputting the at least one characteristic number in combination with at least one value for at least one respiration parameter (Brewer (Par. 35 (the ventilation index that represents the respiratory stability)) (Par. 34 (output signals that include respiratory rate)))
Regarding claim 19, modified Brewer further discloses wherein the evaluation device is further configured for detecting an acute exacerbation if the at least one characteristic number indicates a rise of a respiration stability of the patient and a detected respiration parameter indicates a rising respiratory rate (Brewer (Par. 28 (a respiratory rate module that measures the respiration rate that is capable of measuring a respiratory depression event) (Par. 35 (the ventilation index that represents the respiratory stability)) (Par. 36 (alarm module that has specific thresholds for the ventilation index)) (Par. 36 (if the ventilation index crosses a specific threshold, an alarm is generated))) and shallower breathing (Brewer (Par. 32 (Tidal volume measurement)))
Modified Brewer fails to explicitly disclose but highly suggests a respiration stability of the patient and a detected respiration parameter at the same time.
However, Brewer does disclose the processor with the tidal volume module, respiratory rate module, and ventilation index module (Brewer (Par. 22)), where these modules are all capable of operating in an ongoing manner (Brewer (Par 5, 28, 33, 35)), and respiratory stability based on the tidal volume, rate, and/or additional metrics (Brewer (Par. 35)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Brewer and Freeman with that of Brewer to explicitly include a respiration stability of the patient and a detected respiration parameter at the same time as the modules (Brewer (Par. 5, 28, 33, 35 (tidal volume module, respiratory rate module, and ventilation index module) (Par. 35 (ventilation index module)) are all able to operate in an ongoing manner and as such are highly capable of operating at the same time.
Regarding claim 20, modified Brewer further discloses wherein the system further comprises at least one ventilator (Par. 21 (ventilator)).
Claim(s) 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer in view of Freeman as applied to claim 1 above, and further in view of Asanoi (US Pub. No. 20120125337) hereinafter Asanoi.
Brewer and Freeman teach the limitations of claim 1 as described above.
Regarding claim 18, Brewer fails to disclose the limitation of the claim
However, Asanoi teaches wherein the evaluation device is further configured for outputting the at least one characteristic number only after a defined minimum duration of the ventilation and/or for taking account of an action (Par. 246 (the respiratory stability index (RSI), which is the inverse of the standard deviation of the standard respiratory cycle, where the RSI is calculated for each Fourier window of 50 seconds)), and/or wherein the evaluation device is further configured for outputting the at least one characteristic number together with at least one warning as regards undershooting of a minimum duration and/or together with at least one warning as regards undershooting of the minimum duration for an action, the minimum duration comprising at least two hours and/or at least one night sleep phase of the patient (Par. 196 (measurement of the respiratory waveform for 8 hours)).
Brewer, Freeman, and Asanoi are considered to be analogous art to the claimed invention as they are involved with the measurement of respiratory parameters.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brewer and Freeman with that of Asanoi wherein the evaluation device is further configured for outputting the at least one characteristic number only after a defined minimum duration of the ventilation and/or for taking account of an action, and/or wherein the evaluation device is further configured for outputting the at least one characteristic number together with at least one warning as regards undershooting of a minimum duration and/or together with at least one warning as regards undershooting of the minimum duration for an action, the minimum duration comprising at least two hours and/or at least one night sleep phase of the patient through the combination of references as quality of sleep is lowered due to various diseases (Asanoi (Par. 14)), RSI provides information necessary to determine the sleep cycle expression and comfort level for the patient (Asanoi (Par. 242)) and it would have yielded the predictable result of monitoring sleep quality and stability (Asanoi (Par. 246)).
Claim(s) 5-6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer in view of Freeman as applied to claim 1 above, and further in view of McDarby (US Pub. No. 20150230750) hereinafter McDarby.
Brewer and Freeman teach the limitations of claim 1 as described above.
Regarding claim 5, modified Brewer fails to explicitly disclose the limitations of the claim.
Brewer does teach stability thresholds and a scale (Brewer (Par. 35, “The ventilation index may be a score, an amount of time, a condition rating (e.g., red-yellow-green, good-medium-bad, and/or other rating systems), and/or other indices”) (Par. 36, “alarm module 52 is configured generate one or more alarms based on the ventilation index. The generation of an alarm may be based, for example, on a comparison of the ventilation index with a threshold, an observation of the frequency of the index value within a defined range, mapping of the ventilation index to an alarm, and/or other techniques. Comparing the ventilation index with a threshold may include determining an amount of time (or number of breaths) for which the ventilation has crossed the threshold.”).
McDarby teaches wherein the evaluation device is further configured for assigning, to a time period in which a stability rate exceeds a threshold value for the stability, a characteristic number with a value provided for a maximum respiration stability (Par. 63 ( stability rate threshold values chosen based on comparison with a measured respiratory signal and amplitude threshold value) (Par. 62 (where there are maximum and minimum stability rates)) and/or for assigning, to a time period in which the stability rate exceeds a threshold value for the instability, a characteristic number with a value provided for a minimum respiration stability (Par. 65 (a classification of deep sleep made in situations where the calculated respiratory range is smaller than the stability threshold)).
Brewer, Freeman, and McDarby are considered to be analogous art to the claimed invention as they are involved with the measurement of respiratory parameters.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brewer and Freeman with that of McDarby to include wherein the evaluation device is further configured for assigning, to a time period in which a stability rate exceeds a threshold value for the stability, a characteristic number with a value provided for a maximum respiration stability, and/or for assigning, to a time period in which the stability rate exceeds a threshold value for the instability, a characteristic number with a value provided for a minimum respiration stability through the combination of references as it would have yielded the predictable result of identifying the specific sleep stage (McDarby (Par. 66-67)) as sleep information is important for diagnosing and treating some respiratory issues that an individual may have (McDarby (Par. 33)).
Regarding claim 6, Modified Brewer further discloses wherein the evaluation device is further and configured for assigning, to a time period in which the stability rate lies between a threshold value for the stability and a threshold value for the instability, a characteristic number with one value, and for calculating the value from the stability rate by at least one assignment function (Brewer (Par. 35 (the ventilation index that represents the respiratory stability based upon a rate metric, the ventilation index module may output a specific score))(Par. 36 (an alarm module that generates alarms based on the ventilation index and a specific threshold that has been predetermined for when the ventilation index crosses the threshold)) (Claim 4 (Alarms indicate instability))).
Regarding claim 17, modified Brewer fails to explicitly disclose the limitations of the claim. (Examiner's Note: Brewer fails to explicitly disclose the controller for actuating the ventilator).
However, Brewer does disclose achieving a higher respiration stability by adapting a respiratory gas pressure and/or a respiratory gas flow and/or by adapting at least one of the following parameters: inspiratory pressure level; expiratory pressure level; trigger sensitivity; inspiration duration; expiration duration (Brewer (Par. 14 (monitoring respiratory stability and recommending suggestions of adjustments to a respiratory therapy)).
A person of ordinary skill in the art would not make recommendations for the adjustments to the therapy to go in a direction of worse respiratory stability as the definition of therapeutic is defined as “having a beneficial effect on the body or mind” (Meriam Webster Dictionary). A person of ordinary skill in the art would further recognize that the suggestions for the adjustments to the respiration therapy, as taught by Brewer (Brewer (Par. 14)), involve changing an aspect of an individual’s respiratory pattern, which reads on adapting the inspiration or expiration duration.
McDarby teaches wherein the evaluation device is further configured for achieving a higher respiration stability by adapting a respiratory gas pressure (Par. 77 (the controller and the flow generator communicate together to control operation based on the processed signals that were measured and modify the treatment pressure based on those signals)) (Par. 77, 330 (controller adjusts output based on input values, where a servo ventilator that provides different levels of pressure support based on the input provided, where the input may be the peak flow)) and/or a respiratory gas flow and/or by adapting at least one of the following parameters: inspiratory pressure level; expiratory pressure level; trigger sensitivity; inspiration duration; expiration duration; steepness of the pressure transitions between the pressure levels.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brewer and Freeman with that of McDarby to include wherein the evaluation device is further configured for achieving a higher respiration stability by adapting a respiratory gas pressure and/or a respiratory gas flow and/or by adapting at least one of the following parameters: inspiratory pressure level; expiratory pressure level; trigger sensitivity; inspiration duration; expiration duration; steepness of the pressure transitions between the pressure levels through the combination of references as it would have yielded the predictable result of directly and immediately controlling the treatment pressure provided to the patient based on the measured parameters (McDarby (Par. 77)).
Response to Arguments
Applicant’s arguments, filed 10/06/2025, have been fully considered and deemed as not persuasive.
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791