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 .
Claim Objections
Claims 1, 5-14 objected to because of the following informalities:
Regarding Claim 1, line 8, “ventilator” should read as “ventilator system”
Regarding Claims 5-14, line 1, a “,” should be added after “The method of claim _”
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 1-15 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 current condition value" in lines 21 and 23. There is insufficient antecedent basis for this limitation in the claim. Examiner is unsure if applicant is referring to “a current condition value” in line 9 or line 18 or if line 18 was supposed to be “the current condition value”.
Claim 2, 13, and 14 recites the limitation "the current condition value" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1 and its dependencies claims 2-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recite a system two of the statutory categories; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a method for dynamically controlling the operation of a ventilator system in providing mechanical ventilation to a target person. The claims recite an abstract idea in the form of continuously monitoring readings from a plurality of biometric sensors and biomarker calculators corresponding to the target person and periodically: at predetermined titration intervals, determining a current condition value for the target person based one or more readings from said plurality of biometric sensors and biomarker calculators; determining whether the current condition value of the target condition meets the target biometric value according to the comparator formulae; and upon determining that the current condition value does not meet the target biometric value. This represents a mental processes because it can equivalently be done by a person simply observing the readings of the biometric sensors and biomarker calculators and determine a current condition value for the target person are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 1, as a representative example that is applicable to claims 2-15, the abstract idea is defined by the elements of:
A method for dynamically controlling the operation of a ventilator system in providing mechanical ventilation to a target person, comprising:
accessing a prescription for automatic control of the ventilator system in providing mechanical ventilation to the target person,
the prescription comprising: an initial configuration for configuring the ventilator system to provide an initial mechanical ventilation to the target person, a prescribed target biometric value for a target condition of the target person, comparator formulae by which the ventilator determines an ordinal relationship of a current condition value to the prescribed target biometric value; and modification formulae by which the ventilator system generates modification parameters to modify a current configuration of the ventilator system based on the ordinal relationship between the current condition value and the prescribed target biometric value;
configuring the ventilator system according to the initial configuration;
operating the ventilator system according to the initial configuration;
during operation of the ventilator system, continuously monitoring readings from a plurality of biometric sensors and biomarker calculators corresponding to the target person and periodically:
at predetermined titration intervals, determining a current condition value for the target person based one or more readings from said plurality of biometric sensors and biomarker calculators;
determining whether the current condition value of the target condition meets the target biometric value according to the comparator formulae; and
upon determining that the current condition value does not meet the target biometric value;
generating modification parameters to modify the current configuration of the ventilator system based on the ordinal relationship between the current condition value and the prescribed target biometric value; and
reconfiguring the current configuration of the ventilator system according to the modification parameters.
The above bolded limitations recite a method for dynamically controlling the operation of a ventilator system in providing mechanical ventilation to a target person, configuring the ventilator system according to the initial configuration; operating the ventilator system according to the initial configuration; during operation of the ventilator system, continuously monitoring readings from a plurality of biometric sensors and biomarker calculators corresponding to the target person and periodically: at predetermined titration intervals, determining a current condition value for the target person based one or more readings from said plurality of biometric sensors and biomarker calculators; determining whether the current condition value of the target condition meets the target biometric value according to the comparator formulae; and upon determining that the current condition value does not meet the target biometric value generating modification parameters and reconfiguring according to those parameters, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of continuously monitoring readings from a plurality of biometric sensors and biomarker calculators corresponding to the target person and periodically can be carried out in a person’s mind. This is further defining the abstract idea. Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of monitoring a parameter and determining whether the current condition value of the target condition meets the target biometric value according to the comparator formulae can be done through observations. This is further defining mental process in the form of observations, evaluations, judgments, and opinions. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “ventilation system ”, “biometric sensors”, “biomarkers calculators,” “ventilator” does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “biometric sensors”, “biomarkers calculators,” which is used for extra solution data gathering shown in US 20140060150 A1 (para. 0030) US20190053540 A1 (para. 0063), US 20220288398 A1 (para. 0004). Additionally, the use of “ventilator” are field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). In addition, the use of “ventilation system ” has limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as shown in US 20120118285 A1 (para. 0030 and 0063) (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
A “biometric sensors”, “biomarkers calculators,” which is used for extra solution data gathering; “a ventilator system” is general purpose computers and is filed of use or extra solution activity, are all considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The “system” recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component; for example, the additional elements are directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner. The 101 rejection is made because of upon determining that the current condition value does not meet the target biometric value then a change maybe made but if the current condition does meet the target, the system is operating, monitoring, and determining and nothing is changing making the limitation read as abstract idea, then only if the current condition value does not meet then a change may happen but vice versa nothing happens to the abstract idea making it continuous reading. Also, no practical application is made outside an organized human event. A person can reconfigure the current configuration of the ventilator system according to the new parameters when the reading of the current condition value is not met.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim 1 is also applicable to Claim 2-15. In regards to Claims 2-4, the applicant is reciting elements that further limit the claims to include wherein the modification parameters are further based on a correlation of the current condition value to the configuration of the ventilator system; and wherein the initial configuration comprises one or more predetermined parameters and/or operating modes selected from the group consisting of: Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), Pressure control (PC), Volume-Limited Assist Control (AC), Synchronized intermittent Mandatory Ventilation (SIMV), Pressure Support Ventilation (PSV), Continuous Mandatory Ventilation (CMV), High Flow Nasal Therapy (HFNT), High Flow Oxygen Therapy (HFOT), or Spontaneous/Timed mode (S/T); Positive end expiratory pressure (PEEP), Pressure Support (PS), Respiratory rate (RR), Tidal volume (VT), Inspiratory airflow (V'), FiO2, Inspiratory positive applied pressure (IPAP), Peak inspiratory pressure (PIP), Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Expiratory trigger sensitivity, Transpulmonary driving pressure (?P) and combinations thereof. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 5-8, the applicant is reciting elements that further limit the claims to include wherein the sensor readings comprise readings selected from the group consisting of: heart rate, respiratory rate, blood pressure, Oxygen Saturation (SpO2) End-Tidal Carbon Dioxide (ETCO2), Minute Ventilation (V?), Exhaled Tidal Volume (Vte), Static Lung Compliance (Cstat), Intrinsic PEEP (iPEEP), Apnea Hypopnea Index (AHI), Asynchrony Index (AI), Peak Inspiratory Flow (PIF), Peak Expiratory Flow (PEF), Percent of Spontaneous Triggers (%Spon), Static Lung Resistance (Rlung), Plateau Pressure (Pplat), Inspiratory to Expiratory Ratio (I:E Ratio), and Respiratory Rate Oxygenation (Rox). This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 9-12, the applicant is reciting elements that further limit the claims to include wherein said biomarker calculators are selected from the group consisting of: Peak inspiratory pressure (PIP), Peak pressure, Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Support pressure, Expiratory trigger sensitivity, Plateau pressure (Pplat), Transpulmonary pressure, Transpulmonary driving pressure (?P), Mechanical energy, Mechanical power and intensity, and Pressure-time product per minute (PTP).This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 13-14, the applicant is reciting elements that further limit the claims to include wherein the current condition value comprises a mean, median or most recent value of a predetermined biometric sensor and wherein the current condition value comprises a plurality of current condition values, and the comparator formulae determines ordinal relationships between the current condition values and the prescribed target biometric value. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 15, the claim recites a new additional element of “A dynamically configurable ventilator system” which is routine and conditional using as mentioned above. Also, the applicant is reciting elements that further limit the claims to providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method in claim1. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Habashi (WO 2008146264 A2).
Regrading Claim 1, Habashi discloses a method for dynamically controlling the operation of a ventilator system (Fig. 1; 10) in providing mechanical ventilation to a target person, comprising (para. 0032, 0097-0098; claim 1; Examiner notes: system can start and stop controls of ventilation):
accessing a prescription for automatic control of the ventilator system (Fig. 1; 10) in providing mechanical ventilation to the target person, the prescription comprising: an initial configuration for configuring the ventilator system to provide an initial mechanical ventilation to the target person (Fig. 2; 100; para. 0103; Examiner notes: Prior art teaches during initial ventilator startup, a number of initial parameters are set based upon input from the clinician or by accessing a predefined set of parameters)
a prescribed target biometric value for a target condition of the target person (para. 0051; “a target peripheral 02 concentration or an SpO2 quantity”),
comparator formulae by which the ventilator determines an ordinal relationship of a current condition value to the prescribed target biometric value (para. 0066; Fig. 3A; claim 1; Examiner notes: The command routine compares the patient actual data array to at least one of the settings); and
modification formulae by which the ventilator system generates modification parameters to modify a current configuration (left side of Fig. 3A) of the ventilator system based on the ordinal relationship between the current condition value and the prescribed target biometric value (Fig. 3A-3B; para. 104-105; Examiner notes: the modification can be done on the detected of hypoventilation);
configuring the ventilator system according to the initial configuration (Fig. 2; para. 103-104; initial set-up);
operating the ventilator system according to the initial configuration (Fig. 2; Examiner notes: this figure is showing adjusting/monitoring that is done at the initial configuration);
during operation of the ventilator system, continuously monitoring readings from a plurality of biometric sensors (56, 58) biomarker calculators corresponding to the target person and periodically: at predetermined titration intervals, determining a current condition value for the target person based one or more readings from said plurality of biometric sensors and biomarker calculators (Fig. 2-4; para. 104-106; Examiner notes: the patient's SpO2 and etCO2 are continuously monitored via the respective SpO2 and etC02 sensors 56, 58);
determining whether the current condition value of the target condition meets the target biometric value according to the comparator formulae (Fig. 3A-3B; para. 104-105; Examiner notes: current value is compared with the target value); and
upon determining that the current condition value does not meet the target biometric value; generating modification parameters to modify the current configuration of the ventilator system based on the ordinal relationship between the current condition value and the prescribed target biometric value (Fig. 3A-3B; para. 104-105; increasing the t(low) by 0.5 seconds); and
reconfiguring the current configuration of the ventilator system according to the modification parameters (Fig. 2; para. 0104-016; the parameter is changed).
Regrading Claim 2, Habashi discloses the method of claim 1, wherein the modification parameters are further based on a correlation of the current condition value to the configuration of the ventilator system (Fig. 3A-3B; para. 0104-106).
Regrading Claim 3, Habashi discloses the method of claim 1, wherein the initial configuration comprises one or more predetermined parameters and/or operating modes selected from the group consisting of: Continuous Positive Airway Pressure (CPAP) (para. 0048).
Regrading Claim 4, Habashi discloses the method of claim 2, wherein the initial configuration comprises one or more predetermined parameters and/or operating modes selected from the group consisting of: Continuous Positive Airway Pressure (CPAP) (para. 0048), Bi-Level Positive Airway Pressure (BiPAP), Pressure control (PC), Volume-Limited Assist Control (AC), Synchronized intermittent Mandatory Ventilation (SIMV), Pressure Support Ventilation (PSV), Continuous Mandatory Ventilation (CMV), High Flow Nasal Therapy (HFNT), High Flow Oxygen Therapy (HFOT), or Spontaneous/Timed mode (S/T); Positive end expiratory pressure (PEEP), Pressure Support (PS), Respiratory rate (RR), Tidal volume (VT), Inspiratory airflow (V'), FiO2, Inspiratory positive applied pressure (IPAP), Peak inspiratory pressure (PIP), Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Expiratory trigger sensitivity, Transpulmonary driving pressure (?P) and combinations thereof.
Regrading Claim 5, Habashi discloses the method of claim 1 wherein the sensor readings comprise readings selected from the group consisting of: heart rate, respiratory rate, blood pressure, Oxygen Saturation (SpO2) End-Tidal Carbon Dioxide (ETCO2), Minute Ventilation (V?), Exhaled Tidal Volume (Vte), Static Lung Compliance (Cstat), Intrinsic PEEP (iPEEP), Apnea Hypopnea Index (AHI), Asynchrony Index (AI), Peak Inspiratory Flow (PIF), Peak Expiratory Flow (PEF), Percent of Spontaneous Triggers (%Spon), Static Lung Resistance (Rlung), Plateau Pressure (Pplat), Inspiratory to Expiratory Ratio (I:E Ratio), and Respiratory Rate Oxygenation (Rox) (claim 1).
Regrading Claim 6, Habashi discloses the method of claim 2 wherein the sensor readings comprise readings selected from the group consisting of: heart rate, respiratory rate, blood pressure, Oxygen Saturation (SpO2) End-Tidal Carbon Dioxide (ETCO2), Minute Ventilation (V?), Exhaled Tidal Volume (Vte), Static Lung Compliance (Cstat), Intrinsic PEEP (iPEEP), Apnea Hypopnea Index (AHI), Asynchrony Index (AI), Peak Inspiratory Flow (PIF), Peak Expiratory Flow (PEF), Percent of Spontaneous Triggers (%Spon), Static Lung Resistance (Rlung), Plateau Pressure (Pplat), Inspiratory to Expiratory Ratio (I:E Ratio), and Respiratory Rate Oxygenation (Rox) (claim 1).
Regrading Claim 7, Habashi discloses the method of claim 3 wherein the sensor readings comprise readings selected from the group consisting of: heart rate, respiratory rate, blood pressure, Oxygen Saturation (SpO2) End-Tidal Carbon Dioxide (ETCO2), Minute Ventilation (V?), Exhaled Tidal Volume (Vte), Static Lung Compliance (Cstat), Intrinsic PEEP (iPEEP), Apnea Hypopnea Index (AHI), Asynchrony Index (AI), Peak Inspiratory Flow (PIF), Peak Expiratory Flow (PEF), Percent of Spontaneous Triggers (%Spon), Static Lung Resistance (Rlung), Plateau Pressure (Pplat), Inspiratory to Expiratory Ratio (I:E Ratio), and Respiratory Rate Oxygenation (Rox) (claim 1).
Regrading Claim 8, Habashi discloses the method of claim 4 wherein the sensor readings comprise readings selected from the group consisting of: heart rate, respiratory rate, blood pressure, Oxygen Saturation (SpO2) End-Tidal Carbon Dioxide (ETCO2), Minute Ventilation (V?), Exhaled Tidal Volume (Vte), Static Lung Compliance (Cstat), Intrinsic PEEP (iPEEP), Apnea Hypopnea Index (AHI), Asynchrony Index (AI), Peak Inspiratory Flow (PIF), Peak Expiratory Flow (PEF), Percent of Spontaneous Triggers (%Spon), Static Lung Resistance (Rlung), Plateau Pressure (Pplat), Inspiratory to Expiratory Ratio (I:E Ratio), and Respiratory Rate Oxygenation (Rox) (claim 1).
Regrading Claim 9, Habashi discloses the method of claim 1 wherein said biomarker calculators are selected from the group consisting of: Peak inspiratory pressure (PIP), Peak pressure, Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Support pressure, Expiratory trigger sensitivity, Plateau pressure (Pplat), Transpulmonary pressure, Transpulmonary driving pressure (?P), Mechanical energy, Mechanical power and intensity, and Pressure-time product per minute (PTP) (para. 0051-0055).
Regrading Claim 10, Habashi discloses the method of claim 2 wherein said biomarker calculators are selected from the group consisting of: Peak inspiratory pressure (PIP), Peak pressure, Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Support pressure, Expiratory trigger sensitivity, Plateau pressure (Pplat), Transpulmonary pressure, Transpulmonary driving pressure (?P), Mechanical energy, Mechanical power and intensity, and Pressure-time product per minute (PTP) ) (para. 0051-0055).
Regrading Claim 11, Habashi discloses the method of claim 3 wherein said biomarker calculators are selected from the group consisting of: Peak inspiratory pressure (PIP), Peak pressure, Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Support pressure, Expiratory trigger sensitivity, Plateau pressure (Pplat), Transpulmonary pressure, Transpulmonary driving pressure (?P), Mechanical energy, Mechanical power and intensity, and Pressure-time product per minute (PTP) ) (para. 0051-0055).
Regrading Claim 12, Habashi discloses the method of claim 4 wherein said biomarker calculators are selected from the group consisting of: Peak inspiratory pressure (PIP), Peak pressure, Inspiratory time, Inspiratory-to-expiratory ratio, Time of pause, Trigger sensitivity, Support pressure, Expiratory trigger sensitivity, Plateau pressure (Pplat), Transpulmonary pressure, Transpulmonary driving pressure (?P), Mechanical energy, Mechanical power and intensity, and Pressure-time product per minute (PTP) (para. 0051-0055).
Regrading Claim 13, Habashi discloses the method of claim 1 wherein the current condition value comprises a mean, median or most recent value of a predetermined biometric sensor (para. 0117).
Regrading Claim 14, Habashi discloses the method of claim 1 wherein the current condition value comprises a plurality of current condition values (claim 1), and the comparator formulae determines ordinal relationships between the current condition values and the prescribed target biometric values (Claim 1; many different condition can be used).
Regrading Claim 15, Habashi discloses a dynamically configurable ventilator system (Fig. 1) for providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method of Claim 1 (Claim 1; para. 0032, 0097-0098).
Conclusion
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights