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
The amendment filed 11/20/2025 has been entered. Claims 1-19 remain pending in the application, and claim 21 has been newly added. Applicant’s amendments to the claims and drawings have overcome the objections previously set forth in the Non-Final Office Action mailed 08/28/2025.
Response to Arguments
Applicant’s arguments presented in “Remarks” dated 11/20/2025 have been carefully considered. The drawing and claim objections have been withdrawn in light of the amendments to each.
Applicant’s arguments with respect to amended claims 1 and 11 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. The scope of the claims has changed from the computing device selecting a ventilation parameter having the highest probability of positively influencing the current ventilation to selecting a ventilation parameter having a highest probability of causing the patient ventilation to be terminated. Please see below for the updated rejection.
Claim Objections
Claim 11 is objected to because of the following informalities: there is a typographical error in line 8, page 7: “the predicting model” has been previously recited as “the prediction model”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-13, 15-18, and 21 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Gross et al. (US 2023/0157544 A1), hereafter Gross.
Regarding Claim 1, Gross discloses a machine-implemented method for predicting a parameter for adjusting an operational mode of a ventilator (fig. 4 [0067]), comprising: receiving, by one or more first computing devices (fig. 1, training application 122 [0041]), a plurality of sets of sampled ventilation parameter values for a plurality of patient ventilations in a patient population (fig. 4, historical health data of ventilator patients 402 [0068]), each patient ventilation being associated with a group of ventilation parameters for which one or more of the plurality of sets is sampled during a same time period ([0068] and [0057]); receiving, by the one or more first computing devices, a plurality of weaning indicators ([0057] the predictive model is trained to select the best indicators for weaning), each of the plurality of weaning indicators representing an outcome of a respective patient ventilation of the plurality of patient ventilations and during which one or more of the plurality of sets were sampled ([0068]); generating, by the one or more first computing devices, a trained prediction model based on the received plurality of sets of sampled ventilation parameter values and the received plurality of weaning indicators (fig. 4, 404 [0068]), wherein the trained prediction model is trained to, based on an input of ventilation parameter values for corresponding ventilation parameters sampled during a current patient ventilation performed by a ventilator ([fig. 4, 406 [0068]): determine, for the ventilation parameters of the current patient ventilation, a likelihood that the current patient ventilation can be terminated ([0064] the predictive model identifies parameters with a high likelihood of leading to successful extubation, i.e. the termination of ventilation) based on setting a respective ventilation parameter of the ventilation parameters to a parameter value or to a value within a range of parameter values ([0064]), and select, a ventilation parameter of the ventilation parameters and a corresponding parameter value or range of parameter values having a highest probability, within the group of ventilation parameters, of positively influencing of causing the current patient ventilation to be terminated (fig. 4, 410 [0068]); receiving, by the one or more second computing devices (fig. 1, control application 118 receives current data [0042]), the ventilation parameter values for the corresponding ventilation parameters sampled during the current patient ventilation (fig. 4, 406 [0068]); automatically inputting, by the one or more second computing devices, the ventilation parameter values for the corresponding ventilation parameters sampled during the current patient ventilation into the trained prediction model (fig. 4, 408 [0068]); selecting, by the trained prediction model based on the inputting of ventilation parameter values for the corresponding ventilation parameters, a selected ventilation parameter and corresponding selected parameter value or selected range of parameter values having the highest probability of causing the current patient ventilation to be terminated (fig. 4, 410 [0068]); causing, by the one or more second computing devices, an operational mode of a ventilator associated with the current patient ventilation to be adjusted based on setting the selected ventilation parameter on the ventilator to the selected parameter value or a value within the selected range of parameter values selected by the trained prediction model ([0029] the weaning platform itself may control ventilators without human intervention).
Regarding Claim 2, Gross discloses a method of Claim 1, wherein the trained prediction model selects the ventilation parameter and a corresponding selected parameter value or range of parameter values (fig. 4, 410 [0068] the trained model selects recommended timing and method for ventilator weaning) which satisfies a threshold value of the selected ventilation parameter ([0064] the predictive model 120 identifies parameters with a high likelihood of leading to successful extubation for the particular patient), and wherein each outcome indicates whether the patient ventilation associated with a given patient was reduced or terminated during a given sampling period ([[0068] fig. 4, 406, the training data includes historical health data to identify timing and methods for weaning based on successful outcomes).
Regarding Claim 3, Gross discloses a method of Claim 2, further comprising, by the one or more second computing devices: setting the selected ventilation parameter on the ventilator with the parameter value or range of parameter values received from the trained prediction model ([0029] the ventilator may automatically adjust settings); receiving a plurality of updated ventilation parameter values sampled during the current patient ventilation, after setting the selected ventilation parameter ([0037] the monitoring data is ongoing in order to aggregate data leading to extubation); automatically inputting the plurality of updated ventilation parameter values sampled during the current patient ventilation into the trained prediction model (in order to complete ongoing monitoring, the step of 406 is understood to be repeated); receiving, from the trained prediction model, based on the inputting of the plurality of updated ventilation parameter values, an updated ventilation parameter selected from the group of ventilation parameters and an updated parameter value or updated range of parameter values for the updated ventilation parameter (fig. 4 408 and 410); and setting the updated ventilation parameter on the ventilator with the updated parameter value or updated value within the updated range of parameter values received from the trained prediction model ([0029] the settings may be adjusted based on new input from the patient’s current condition).
Regarding Claim 5, Gross discloses a method of Claim 2, further comprising, by the one or more second computing devices: determining a likelihood that a patient associated with the current patient ventilation is a candidate for extubation and termination of the current patient ventilation based on the adjustment of the operational mode of the ventilator based on the ventilation parameter being set to the parameter value or to a value within the range of parameter values (Gross [0053]).
Regarding Claim 6, Gross discloses a method of Claim 5, further comprising, by the one or more second computing devices: sending the selected ventilation parameter and the parameter value or range of parameter values to a computing device associated with a clinician assigned to the current patient ventilation (Gross [0054]).
Regarding Claim 7, Gross discloses a method of Claim 1, wherein each of the plurality of weaning indicators indicates whether a respective patient was extubated during the same time period associated with the respective patient ventilation ([0055] the predictive model is trained using data including time of extubation).
Regarding Claim 8, Gross discloses a method of Claim 1, wherein each of the plurality of weaning indicators corresponds to a patient outcome for a respective patient of the patient population, each patient outcome indicating whether the patient ventilation associated with a given patient was reduced or terminated during the sampling period ([0055]).
Regarding Claim 9, Gross discloses a method of Claim 1, wherein a respective set of the plurality of sets of sampled ventilation parameter values corresponds to a ventilation statistic or measurement indicating one of: inspiratory-expiratory ratio (IE), total lung ventilation per minute (Ve), or peak expiratory flow rate (PEFR), peak inspiratory flow rate (PIFR) ([0030]).
Regarding Claim 10, Gross discloses a method of Claim 1, wherein the one or more first computing devices and the one or more second computing devices are different computing devices (fig. 1, the predictive training application 122 is a different computing device than the control application 118 which receives data a ventilation settings [0042]).
Regarding Claim 11, Gross discloses a system, comprising: one or more first computing devices configured to execute first instructions (fig. 1, computing device 106 having predictive model training application 122 [0041]) to: receive a plurality of sets of sampled ventilation parameter values (fig. 4, 402 [0068]) for a plurality of patient ventilations in a patient population ([0068] data is from historical patient data), each patient ventilation being associated with a group of ventilation parameters for which one or more of the plurality of sets is sampled during a same time period ([0068]);
receive a plurality of weaning indicators ([0057] the predictive model is trained to select the best indicators for weaning), each of the plurality of weaning indicators representing an outcome of a respective patient ventilation of the plurality of patient ventilations and during which one or more of the plurality of sets were sampled ([0068]); and
generate a trained prediction model based on the received plurality of sets of sampled ventilation parameter values (fig. 4, 404 [0068]) and the received plurality of weaning indicators (fig. 4, 404 [0068]), wherein the trained prediction model is trained to, based on an input of ventilation parameter values for corresponding ventilation parameters sampled during a current patient ventilation performed by a ventilator (fig. 4, 404 [0068]),
determine, for the ventilation parameters of the current patient ventilation, a likelihood that the current patient ventilation can be terminated based on setting a respective ventilation parameter of the ventilation parameters to a parameter value or to a value within a range of parameter values ([fig. 4, 410 [0068]), and
select a ventilation parameter of the ventilation parameters and a corresponding parameter value or range of parameter values having a highest probability of causing the current patient ventilation to be terminated (fig. 4, 410 includes selecting timing and methodology for ventilation parameters to wean the patient [0068]; [0064] the predictive model identifies parameters with a high likelihood of leading to successful extubation, i.e. the termination of ventilation);
and one or more second computing devices (fig. 1, control application 118 [0042]) configured to execute second instructions to: receive the ventilation parameter values for the corresponding ventilation parameters sampled during the current patient ventilation ([0042]); automatically input the ventilation parameter values for the corresponding ventilation parameters sampled during the current patient ventilation into the trained prediction model (fig. 4 406 [0068]); selecting, by the trained predicting model, based on the inputting of the ventilation parameter values for the corresponding ventilation parameters, a selected ventilation parameter value and corresponding selected parameter value or selected range of parameter values (fig. 4, 408 and 410, apply and identify methodology for weaning [0068]) having the highest probability of causing the current patient ventilation to be terminated (0064] the predictive model identifies parameters with a high likelihood of leading to successful extubation, i.e. the termination of ventilation); and cause an operational mode of a ventilator associated with the current patient ventilation to be adjusted based setting the selected ventilation parameter on the ventilator to the selected parameter value or a value within the selected range of parameter values selected by the trained prediction model ([0031]; [0029] the weaning platform itself may control ventilators without human intervention).
Regarding Claim 12, Gross discloses a system of Claim 11, wherein the trained prediction model selects the selected ventilation parameter and corresponding selected parameter value or range of parameter values (fig. 4, 410 [0068] the trained model selects recommended timing and method for ventilator weaning) which satisfies a threshold value of the selected ventilation parameter ([0064] the predictive model 120 identifies parameters with a high likelihood of leading to successful extubation for the particular patient), and wherein each outcome indicates whether the patient ventilation associated with a given patient was reduced or terminated during a given sampling period ([[0068] fig. 4, 406, the training data includes historical health data to identify timing and methods for weaning based on successful outcomes).
Regarding Claim 13, Lain discloses a system of Claim 12, wherein the one or more second computing devices (fig. 1, control application 118 [0042]) are further configured to execute the second instructions to: set the selected ventilation parameter on the ventilator with the parameter value or range of parameter values received from the trained prediction model ([0029] the platform may automatically adjust ventilator settings); receive a plurality of updated ventilation parameter values sampled during the current patient ventilation, after setting the selected ventilation parameter ([0037] the monitoring data is ongoing in order to aggregate data leading to extubation); automatically input the plurality of updated ventilation parameter values sampled during the current patient ventilation into the trained prediction model (in order to complete ongoing monitoring, the step of 406 is understood to be repeated); receive, from the trained prediction model, based on the inputting of the plurality of updated ventilation parameter values, an updated ventilation parameter selected from the group of ventilation parameters and an updated parameter value or updated range of parameter values for the updated ventilation parameter (fig. 4 408 and 410); and set the updated ventilation parameter on the ventilator with the updated parameter value or updated value within the updated range of parameter values received from the trained prediction model (it is understood that the adjustment of ventilation settings based on feedback data from the patient is iterative until extubation [0037]; [0029] the settings may be adjusted based on new input from the patient’s current condition).
Regarding Claim 15, Gross discloses a system of Claim 12, wherein the one or more second computing devices are further configured to execute the second instructions to: determine a likelihood that a patient associated with the current patient ventilation is a candidate for extubation and termination of the current ventilation based on the adjustment of the operational mode of the ventilator based on the ventilation parameter being set to the parameter value or to a value within the range of parameter values (Gross [0053]).
Regarding Claim 16, Gross discloses a system of Claim 15, wherein the one or more second computing devices are further configured to execute the second instructions to: send the selected ventilation parameter and the parameter value or range of parameter values to a computing device associated with a clinician assigned to the current patient ventilation (Gross [0054]).
Regarding Claim 17, Gross discloses a system of Claim 11, wherein each of the plurality of weaning indicators indicates whether a respective patient was extubated during the same time period associated with the respective patient ventilation ([0055]) the predictive model is trained using data including time of extubation).
Regarding Claim 18, Lain discloses a system of Claim 11, but does not explicitly disclose wherein each of the plurality of weaning indicators corresponds to a patient outcome for a respective patient of the patient population, each patient outcome indicating whether the patient ventilation associated with a given patient was reduced or terminated during the sampling period ([0055]).
Regarding Claim 21, Gross discloses a system of claim 11, wherein the one or more first computing devices and the one or more second computing devices are different computing devices (fig. 1, the predictive training application 122 is a different computing device than the control application 118 which receives data a ventilation settings [0042]).
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 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 4, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Lain et al. (WO 2010/150264 A1), hereafter Lain.
Regarding Claim 4, Gross discloses a method of Claim 3, further comprising: by the trained prediction model, assigning the current patient ventilation to one of a plurality of cluster categories ([0045] data can be sorted into health status categories) based on the plurality of updated ventilation parameter values sampled during the current patient ventilation ([0045]), each cluster category being associated with a probability that current patient ventilation is a candidate for extubation or termination of the current patient ventilation ([0045]; the categories are associated with good/intermediate/bad status, which one of ordinary skill in the art would have been able to correlate to whether the patient is able to be weaned).
However, Gross is silent on by the trained prediction model, selecting the updated parameter value or updated value within the updated range of parameter values based on the cluster category assigned to the current patient ventilation (emphasis added), wherein as the probability decreases, the less the updated parameter value or updated value within the updated range of parameter values differs from a current value of the updated parameter value toward weaning or terminating the current ventilation.
However, Lain teaches a trained prediction model for weaning a patient from ventilation (abstract) which uses cluster categories (fig. 3, a pulmonary index (IPI or PI) is used to adjust ventilation parameters, page 3 first para.; the index reflects a risk to the patient’s health including low and high risk categories, page 49 last para.), wherein as the probability of weaning decreases, the less the updated ventilation parameter differs from a current ventilation parameter (page 22 last para. to page 23, a decreasing IPI score means that a patient is not ready to be weaned; i.e., the ventilation settings will not be reduced, page 23 lines 25-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross’s method to use the health status categories as taught by Lain, to select the updated parameter value within the updated range of parameter values based on the cluster category assigned to the current patient ventilation, wherein as the probability decreases, the less the updated parameter value or updated value within the updated range of parameter values differs from a current value of the updated parameter value toward weaning or terminating the current ventilation, so that if a patient is classified in a category that is not ready for weaning, the updated settings will not be changed from the current ventilation support settings (Lain page 24 first para.).
Regarding Claim 14, Gross discloses a system of Claim 13, wherein the one or more second computing devices are further configured to execute the second instructions to: cause the trained prediction model to assign the current patient ventilation to one of a plurality of cluster categories ([0045] data can be sorted into health status categories) based on the plurality of updated ventilation parameter values sampled during the current patient ventilation ([0045]), each cluster category being associated with a probability that current patient ventilation is a candidate for extubation or termination of the current ventilation ([0045]; the categories are associated with good/intermediate/bad status, which one of ordinary skill in the art would have been able to correlate to whether the patient is able to be weaned).
However, Gross is silent on the second computing device being able to cause the trained prediction model to select the updated parameter value or updated value within the updated range of parameter values based on the cluster category assigned to the current patient ventilation (emphasis added), wherein as the probability decreases, the less the updated parameter value or updated value within the updated range of parameter values differs from a current value of the updated parameter value toward weaning or terminating the current patient ventilation.
However, Lain teaches a trained prediction model for weaning a patient from ventilation (abstract) which uses cluster categories (fig. 3, a pulmonary index (IPI or PI) is used to adjust ventilation parameters, page 3 first para.; the index reflects a risk to the patient’s health including low and high risk categories, page 49 last para.), wherein as the probability of weaning decreases, the less the updated ventilation parameter differs from a current ventilation parameter (page 22 last para. to page 23, a decreasing IPI score means that a patient is not ready to be weaned; i.e., the ventilation settings will not be reduced, page 23 lines 25-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross’s method to use the health status categories as taught by Lain, to select the updated parameter value within the updated range of parameter values based on the cluster category assigned to the current patient ventilation, wherein as the probability decreases, the less the updated parameter value or updated value within the updated range of parameter values differs from a current value of the updated parameter value toward weaning or terminating the current ventilation, so that if a patient is classified in a category that is not ready for weaning, the updated settings will not be changed from the current ventilation support settings (Lain page 24 first para.).
Regarding Claim 19, Gross discloses a system of Claim 11, further comprising: a ventilation communication device configured to receive the sampled ventilation parameter values (fig. 1, the computing device 106 comprising the ventilator weaning predictive model training application 122 receives historical ventilator patient data 126 and historical ventilator operational data 128 [0055] from a database), wherein the one or more processors second computing devices are further configured to execute the second instructions to: execute the instructions to organize the sampled ventilation parameter values into the plurality of sets of sampled ventilation parameter values ([0063]).
Gross is silent on a medication delivery communication device configured to receive current medication delivery information associated with an ongoing administration of a medication to a patient, wherein the one or more processors second computing devices are further configured to execute the second instructions to: automatically input the current medication delivery information into the trained prediction model, wherein the trained prediction model is further trained based on previously known medication delivery information, and wherein the trained prediction model selects one or more ventilator parameters having the highest probability of positively influencing the patient ventilation based on the respective threshold values and the current medication delivery information.
Lain teaches a system comprising a medication delivery communication device configured to receive current medication delivery information associated with an ongoing administration of a medication to a patient (pages 47-48, additional parameters affecting the IPI include medications given, page 48 line 15; this information is added to the system either manually or by any route of communication, page 47 lines 26-27), and automatically input the current medication delivery information into the trained prediction model, wherein the trained prediction model is further trained based on previously known medication delivery information (page 52, last para., the decision tree incorporates medication into the predictive model), and wherein the trained prediction model selects the one or more ventilator parameters having the highest probability of positively influencing the patient ventilation based on the respective threshold values and the current medication delivery information (since medication is incorporated into the decision tree predictive model, the resulting IPI and ventilation settings adjustments takes into account the current medication delivery information).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a medication delivery communication system and use the medication delivery in the trained prediction model, as well as to select ventilator settings based current medication delivery information as taught by Lain, since medication delivery can have a marked effect on patient status (Lain, page 51 last para., medications including steroids, sedatives, etc. should be included in patient status data collected).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Milne et al. (WO 2012/074958 A1) trains a system with population sampled patient data (page 12 lines 17-30 in particular).
Walsh (US 2018/0325463 A1) discloses a ventilator predictive analysis system which uses a history of measurements and outcomes from a set of patients in order to detect a potential post-extubation outcome in a current patient (see [0009], [0013], [[029-0030]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785