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 2 & 9 – 15 are objected to because of the following informalities:
In claim 2, the word “Claim” should be changed to “claim” in order to maintain consistency.
In claim 9 – 12, the phrase “at lease” does not make sense with the claim limitation. It is believed the phrase should be “at least”.
In claims 13 – 15, the word “Claim” should be changed to “claim” in order to maintain consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim1 – 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of the claims has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Representative claim 9 states the following:
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:
a base configuration for configuring the ventilator system to provide a base mechanical ventilation to the target person, intervention logic for identifying an intervention entrance condition of the target person, and an intervention configuration for configuring the ventilator system to provide interventional mechanical ventilation to the target person;
configuring the ventilator system according to the base configuration;
operating the ventilator system according to the base configuration;
during operation of the ventilator system while configured according to the base configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person;
determining, according to the intervention logic and based on the monitored readings, if an intervention entrance condition is present in the target person; and
if an intervention entrance condition is present, dynamically reconfiguring the ventilator system according to the intervention configuration to provide interventional mechanical ventilation to the target person according to the intervention configuration.
Independent claim 1 recites a method/process, which is a statutory category of invention.
Step 2A, Prong One
Claim 1 recites the following claim limitations that, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human ming, e.g., using pen and paper (mental process grouping):
accessing a prescription for automatic control of the ventilator system in providing mechanical ventilation to the target person (In light of Applicant’s specification, e.g. Paragraph 00109, a human being is able to manually change the prescription to an alternating mode and mentally determine the prescription needed), the prescription comprising:
a base configuration for configuring the ventilator system to provide a base mechanical ventilation to the target person, intervention logic for identifying an intervention entrance condition of the target person, and an intervention configuration for configuring the ventilator system to provide interventional mechanical ventilation to the target person (In light of Applicant’s specification, e.g. Paragraph 0019, a human being is capable of monitoring readings from a plurality of biometric sensors and determine based on the monitored readings if the intervention entrance condition is present, e.g., by mentally noting sensor rada that is obtained from the user and decide if intervention is needed based on the results);
during operation of the ventilator system while configured according to the base configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person (In light of Applicant’s specification, e.g. Paragraph 0019, a human being is capable of monitoring readings from a plurality of biometric sensors and determine based on the monitored readings if the intervention entrance condition is present, e.g., by mentally noting sensor rada that is obtained from the user);
determining, according to the intervention logic and based on the monitored readings, if an intervention entrance condition is present in the target person (In light of Applicant’s specification, e.g. Paragraph 0019, a human being is capable of monitoring readings from a plurality of biometric sensors and determine based on the monitored readings if the intervention entrance condition is present, e.g., by mentally noting sensor rada that is obtained from the user and decide if intervention is needed based on the results; it is noted that there is no recitation of a structure which stores/implements the readings and thus the broad recitation of the decision can be implemented mentally); and
if an intervention entrance condition is present, dynamically reconfiguring the ventilator system according to the intervention configuration to provide interventional mechanical ventilation to the target person according to the intervention configuration (In light of Applicant’s specification, e.g. Paragraph 0019, a human being is capable of monitoring readings from a plurality of biometric sensors and determine based on the monitored readings if the intervention entrance condition is present, e.g., by mentally noting sensor rada that is obtained from the user and decide if intervention is needed based on the results; it is noted that there is no recitation of a structure which stores/implements the readings and thus the broad recitation of the decision can be implemented mentally).
Thus, claim 1 recites the abstract idea of observing or evaluating data and forming an evaluation or judgement based on said data.
Step 2A, Prong Two
Claim 1 recites the following additional elements that, when considered either alone or in an ordered combination, do not integrate the abstract idea into a practical application thereof:
a plurality of biometric sensors (The sensors of the treatment device is recited at a high-level of generality and merely performs the generic sensing-related computer functions of receiving data, which are insignificant extra-solution activity, or in other words, the steps of the claim. See MPEP 2106.05(b), (f), & (g).)
the ventilator system (This refers to a limitation indicative of mere instruction to implement the abstract idea on a computer, or merely using a device as a tool to perform an abstract idea. It is also noted that the treatment device is a recitation of a field of use limitation which is not significantly more than the abstract idea);
Thus, the abstract idea recited claim 1 is not integrated into a practical application and the claim is directed to the abstract idea of observing or evaluating data and forming an evaluation or judgment based on said data.
Step 2B
Claim 1 includes additional elements that do not amount to significantly more than the abstract idea for the following reasons:
A plurality of biometric sensors (This consideration is the same as that noted above from Step 2A, Prong Two, considering the discussion for the sensing and receiving steps below.);
the ventilator system (This refers to a limitation indicative of instructions to implement an abstract idea on the device.)
Thus, claim 1 does not amount to significantly more than the abstract idea of observing or evaluating data and forming an evaluation based on said data since the recited additional elements do not provide for an inventive concept.
Dependent claims
Claims 3 – 15 merely further define the abstract idea by specifying the type of data to be evaluated or the parameters for the evaluation or judgement to be made. Claim 2 is similar to the pre-solution activity above. Thus, these claims do not amount to significantly more than the abstract idea.
Conclusion
For these reasons, claims 1 – 15 are rejected under 35 USC 101 as they constitute patent ineligible subject matter
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 12 & 14 - 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 2, 4 & 8 of copending Application No. 18/741612 in view of Milne et al. (US 20120226444 A1). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, A method for dynamically controlling the operation of a ventilator system in providing mechanical ventilation to a target person (Claim 1), comprising:
accessing a prescription for automatic control of the ventilator system in providing mechanical ventilation to the target person (Claim 1),
the prescription comprising:
a base configuration for configuring the ventilator system to provide a base mechanical ventilation to the target person (Claim 1),
configuring the ventilator system according to the base configuration (Claim 1);
operating the ventilator system according to the base configuration (Claim 1);
during operation of the ventilator system while configured according to the base configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person (Claim 1).
App. 18/741612 does not disclose intervention logic for identifying an intervention entrance condition of the target person, and an intervention configuration for configuring the ventilator system to provide interventional mechanical ventilation to the target person;
determining, according to the intervention logic and based on the monitored readings, if an intervention entrance condition is present in the target person; and
if an intervention entrance condition is present, dynamically reconfiguring the ventilator system according to the intervention configuration to provide interventional mechanical ventilation to the target person according to the intervention configuration.
Milne discloses a ventilation module 212 that oversees the ventilation of a patient according to ventilatory settings. The ventilatory settings may include any appropriate input for configuring the ventilator to deliver breathable gases to a particular patient. The ventilation settings may be automatically generated by the ventilator based on the attributes of the patient according to any appropriate standard protocol or otherwise. (Paragraph 0030)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify App. 18/741612 to include intervention logic for identifying an intervention entrance condition of the target person, and an intervention configuration for configuring the ventilator system to provide interventional mechanical ventilation to the target person, determining, according to the intervention logic and based on the monitored readings, if an intervention entrance condition is present in the target person and if an intervention entrance condition is present, dynamically reconfiguring the ventilator system according to the intervention configuration to provide interventional mechanical ventilation to the target person according to the intervention configuration in order to have the correct adjustments be made that can address certain patient conditions or the effectiveness of ventilator system. A threshold is used to determine if the conditions are above the normal conditions established to allow the necessary adjustments to be made. (Paragraph 0005)
Regarding claim 2, Modified App. 18/741612 discloses the method as claimed in claim 1.
Modified App. 18/741612 discloses wherein the intervention logic further comprises:
intervention logic for identifying an intervention exit condition of the target person (Claim 1 & 2); and
wherein the method further comprises, during operation of the ventilator system while configured according to the intervention configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person (Claim 1 & 2);
determining, according to the intervention logic and based on the monitored readings, if an intervention exit condition is present in the target person (Claim 1 & 2); and
if an intervention exit condition is present, dynamically reconfiguring the ventilator system to provide the base mechanical ventilation to the target person according to the base configuration. (Claim 1 & 2)
Regarding claim 3, Modified App. 18/741612 discloses the method as claimed in claim 1.
Modified App. 18/741612 discloses wherein the base configuration and the intervention configuration each comprise one or more predetermined operational 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 (ΔP) and combinations thereof (Claim 3).
Regarding claim 4, Modified App. 18/741612 discloses the method as claimed in claim 2.
Modified App. 18/741612 discloses wherein the base configuration and the intervention configuration each comprise one or more predetermined operational 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 (ΔP) and combinations thereof (Claim 4).
Regarding claim 5, Modified App. 18/741612 discloses the method as claimed in claim 1.
Modified App. 18/741612 discloses wherein the biometric 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 5).
Regarding claim 6, Modified App. 18/741612 discloses the method as claimed in claim 2.
Modified App. 18/741612 discloses wherein the biometric 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 6).
Regarding claim 7, Modified App. 18/741612 discloses the method as claimed in claim 3.
Modified App. 18/741612 discloses wherein the biometric 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 7).
Regarding claim 8, Modified App. 18/741612 discloses the method as claimed in claim 4.
Modified App. 18/741612 discloses wherein the biometric 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 8).
Regarding claim 9, Modified App. 18/741612 discloses the method as claimed in claim 1.
Modified App. 18/741612 discloses wherein the intervention logic comprises at lease one selected operational parameter and an entrance threshold for the selected operational parameter. (Claim 1 & 2)
Regarding claim 10, Modified App. 18/741612 discloses the method as claimed in claim 2.
Modified App. 18/741612 discloses wherein the intervention logic comprises at lease one selected operational parameter, an entrance threshold for the selected operational parameter, and an exit threshold for the operational parameter. (Claim 1 & 2)
Regarding claim 11, Modified App. 18/741612 discloses the method as claimed in claim 3.
Modified App. 18/741612 discloses wherein the intervention logic comprises at lease one selected operational parameter and an entrance threshold for the selected operational parameter. (Claim 1 & 2)
Regarding claim 12, Modified App. 18/741612 discloses the method as claimed in claim 4.
Modified App. 18/741612 discloses wherein the intervention logic comprises at lease one selected operational parameter, an entrance threshold for the selected operation parameter, and an exit threshold for the operational parameter. (Claim 1 & 2)
Regarding claim 13, Modified App. 18/741612 discloses a dynamically configurable ventilator system 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)
Regarding claim 14, Modified App. 18/741612 a dynamically configurable ventilator system for providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method of Claim 2. (Claim 1)
Regarding claim 15, Modified App. 18/741612 a dynamically configurable ventilator system for providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method of Claim 4. (Claim 1)
Claim Objections
Claims 1 & 13 - 15 are objected to because of the following informalities:
Change the word “Claim” to “claim” in order to maintain consistency.
Change the word “lease” in claims 9 – 12 in order to be grammatically correct.
Based on the examiners understanding of the specification [0022], the limitations of claims 5 – 8 is considered as “one or more readings selected from the group consisting of”.
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)(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.
(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.
Claim(s) 1, 5 & 13 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Wondka et al. (WO 2010039989 A1).
Regarding claim 1, A method for dynamically controlling the operation of a ventilator system in providing mechanical ventilation to a target person (Paragraph 000105), comprising:
accessing a prescription for automatic control of the ventilator system in providing mechanical ventilation to the target person (Paragraph 000102), the prescription comprising:
a base configuration for configuring the ventilator system to provide a base mechanical ventilation to the target person (Paragraph 00073 discloses the doctor setting a specific ventilator setting), intervention logic for identifying an intervention entrance condition of the target person (Paragraph 00028 discloses the detection of exacerbation events), and an intervention configuration for configuring the ventilator system to provide interventional mechanical ventilation to the target person (Paragraph 000105 & 00092);
configuring the ventilator system according to the base configuration (Paragraph 00074);
operating the ventilator system according to the base configuration (Paragraph 00074);
during operation of the ventilator system while configured according to the base configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person (Paragraph 00059);
determining, according to the intervention logic and based on the monitored readings, if an intervention entrance condition is present in the target person (Paragraph 000105); and
if an intervention entrance condition is present, dynamically reconfiguring the ventilator system according to the intervention configuration to provide interventional mechanical ventilation to the target person according to the intervention configuration (Paragraph 000105).
Regarding claim 5, Wondka discloses the method as claimed in claim 1.
Wondka discloses wherein the biometric sensor readings comprise readings selected from the group consisting of: respiratory rate, Oxygen Saturation (SpO2) and End-Tidal Carbon Dioxide (ETCO2). (Paragraph 000105)
Regarding claim 13, Wondka discoses a dynamically configurable ventilator system for providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method of Claim 1. (as claimed in claim 1 / Paragraph 000102)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2, 6 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wondka et al. (WO 2010039989 A1).
Regarding claim 2, Wondka discloses the method as claimed in Claim 1.
Wondka does not disclose wherein the intervention logic further comprises:
intervention logic for identifying an intervention exit condition of the target person; and wherein the method further comprises, during operation of the ventilator system while configured according to the intervention configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person;
determining, according to the intervention logic and based on the monitored readings, if an intervention exit condition is present in the target person; and
if an intervention exit condition is present, dynamically reconfiguring the ventilator system to provide the base mechanical ventilation to the target person according to the base configuration.
However, Wondka discloses the ventilator setting is in response to a detected temporary critical condition of the patient and eventually when the patient is in uncritical medical state again, the ventilation parameters will be turned down again. (Paragraph 000105)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Wondka to include wherein the intervention logic further comprises: intervention logic for identifying an intervention exit condition of the target person; and wherein the method further comprises, during operation of the ventilator system while configured according to the intervention configuration, continuously monitoring readings from a plurality of biometric sensors corresponding to the target person, determining, according to the intervention logic and based on the monitored readings, if an intervention exit condition is present in the target person and
if an intervention exit condition is present, dynamically reconfiguring the ventilator system to provide the base mechanical ventilation to the target person according to the base configuration as permanently maintaining more ventilator support or more oxygen after the predicted issues would eventually result in providing more oxygen to the patient than needed. It also discloses if the goals are met, the ventilation parameters are turned down in order to reduce the patient’s dependency on the medical ventilation, meaning if more oxygen is given and not turned down the dependency of the user would be increased. (Paragraph 00075)
Regarding claim 6, Modified Wondka discloses the method as claimed in claim 2.
Modified Wondka discloses wherein the biometric sensor readings comprise readings selected from the group consisting of: respiratory rate, Oxygen Saturation (SpO2) and End-Tidal Carbon Dioxide (ETCO2). (Paragraph 000105)
Regarding claim 14, Wondka discloses a dynamically configurable ventilator system for providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method of Claim 2. ((as claimed in claim 1 / Paragraph 000102)
Claim(s) 3 – 4, 7 – 8, 11 – 12 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wondka et al. (WO 2010039989 A1) as claimed in claim 1, in further view of Nawar et al. (WO 2011090716 A2).
Regarding claim 3, Wondka discloses the method as claimed in claim 1.
Wondka discloses the ventilator can provide more ventilator support. (Paragraph 000105)
Wondka does not expressly disclose wherein the base configuration and the intervention configuration each comprise one or more predetermined operational 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.
Nawar discloses the ventilator can perform one of more of the following modes of ventilation: pressure-cycled ventilation: pressure support ventilation (PSV), and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP). (Claim 16)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Wondka to include wherein the base configuration and the intervention configuration each comprise one or more predetermined operational parameters and/or operating modes selected from the group consisting of: pressure support ventilation (PSV), and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) it is known that contemplated ventilators include those that accomplish many modes of ventilation. By doing different modes it can determine intervention efficacy. (Page 15, paragraph 2 & 3)
Regarding claim 4, Wondka discloses the method as claimed in claim 2.
Wondka discloses the control unit executes a change in ventilator parameters. (Claim 11)
Wondka does not expressly disclose wherein the base configuration and the intervention configuration each comprise one or more predetermined operational 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.
Nawar discloses the ventilator can perform one of more of the following modes of ventilation: pressure-cycled ventilation: pressure support ventilation (PSV), and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP). (Claim 16)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Wondka to include wherein the base configuration and the intervention configuration each comprise one or more predetermined operational parameters and/or operating modes selected from the group consisting of: pressure support ventilation (PSV), and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) it is known that contemplated ventilators include those that accomplish many modes of ventilation. By doing different modes it can determine intervention efficacy. (Page 15, paragraph 2 & 3)
Regarding claim 7, Wondka discloses the method as claimed in claim 3.
Wondka discloses wherein the biometric sensor readings comprise readings selected from the group consisting of: respiratory rate, Oxygen Saturation (SpO2) and End-Tidal Carbon Dioxide (ETCO2). (Paragraph 000105)
Regarding claim 8, Wondka discloses the method as claimed in claim 4.
Wondka discloses wherein the biometric sensor readings comprise readings selected from the group consisting of: respiratory rate, Oxygen Saturation (SpO2) and End-Tidal Carbon Dioxide (ETCO2). (Paragraph 000105)
Regarding claim 11, Modified Wondka discloses the method as claimed in claim 3.
Modified Wondka discloses wherein the intervention logic (as claimed in claim 1) comprises at lease one selected operational parameter (as claimed in claim 3)
Modified Wondka does not expressly disclose an entrance threshold for the selected operational parameter.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Wondka to include an entrance threshold for the selected operational parameter as it would allow the system to determine when the treatment is needed based on the intervention parameters established by the doctor on the therapy of the user. This would allow the system to automatically establish the therapy when needed. (Paragraph 000105)
Regarding claim 12, Modified Wondka discloses the method as claimed in claim 4.
Modified Wondka discloses wherein the intervention logic (as claimed in claim 1) comprises at lease one selected operational parameter (as claimed in claim 3), an entrance threshold (as claimed in claim 1) and an exit threshold. (as claimed in claim 2)
Modified Wondka does not expressly disclose an entrance threshold for the selected operational parameter and an exit threshold for the operational parameter.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Wondka to include an entrance threshold for the selected operational parameter and an exit threshold for the operational parameter as it would allow the system to determine when the treatment is needed based on the intervention parameters established by the doctor on the therapy of the user. This would allow the system to automatically establish the therapy when needed and when the therapy can automatically stop based on the sensors letting the system know the user does not need the intervention anymore. (Paragraph 000105)
Regarding claim 15, Wondka discloses a dynamically configurable ventilator system for providing mechanical ventilation to a target person according to a prescription, configured to operate in accordance with the method of Claim 4. (as claimed in claim 1 / Paragraph 000102)
Claim(s) 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wondka et al. (WO 2010039989 A1) as claimed in claim 1, in further view of Truschel et al. (US 20110197887 A1).
Regarding claim 9, Wondka discloses the method as claimed in claim 1.
Wondka discloses wherein the intervention logic (Note: the examiner considers this to be the selected detection by the user or doctor) comprises an entrance threshold. (as claimed in claim 1)
Wondka does not disclose at lease one selected operational parameter and an entrance threshold for the selected operational parameter.
Truschel discloses one selected operational parameter. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the intervention logic of Wondka to comprise at lease one selected operational parameter and an entrance threshold for the selected operational parameter as it allows the operation for the ventilator to provide a particular type of ventilator therapy which includes CPAP, SIMB, AC, etc. This help can include pressure support ventilation therapy, volume control ventilation therapy and suitable combinations thereof. By including this parameter for the entrance threshold will allow to ventilator to know what therapy is needed based on the needs of the patient. (Paragraph 0019 & 0023)
Regarding claim 10, Modified Wondka discloses the method as claimed in claim 2.
Modified Wondka discloses wherein the intervention logic comprises at lease one selected operational parameter, an entrance threshold for the selected operational parameter, and an exit threshold for the operational parameter.
wherein the intervention logic (Note: the examiner considers this to be the selected detection by the user or doctor) comprises an entrance threshold. (as claimed in claim 1)
Wondka does not disclose at lease one selected operational parameter and an entrance threshold for the selected operational parameter, and an exit threshold for the operational parameter.
Truschel discloses one selected operational parameter. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the intervention logic of Wondka to comprise at lease one selected operational parameter and an entrance threshold for the selected operational parameter, and an exit threshold for the operational parameter as it allows the operation for the ventilator to provide a particular type of ventilator therapy which includes CPAP, SIMB, AC, etc. This help can include pressure support ventilation therapy, volume control ventilation therapy and suitable combinations thereof. By including this parameter for the entrance threshold and exit threshold to determine when the mode must be applied automatically and when the treatment must automatically stop based on the biometrics sensed. (Paragraph 0019 & 0023)
Conclusion
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/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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