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
Claim 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim one calls to “a health score formulae” by which the ventilator determines a current health score. However, the specification fails to provide information on a formula for determining a health score. While one of ordinary skill in the art would understand how to determine a health score based on one or more biometric variables. The examiner recommends removing “formula” from the claims and instead calling to determining a health score according to one or more biometric variables. Any claims not expressly discussed are rejected by dependency.
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 9-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-12, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-8 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kimm (US 2021/0316094 A1) in view of Dong (US 2021/0393902 A1).
Regarding claim 1, Kimm discloses a method for dynamically controlling the operation of a ventilator system in providing mechanical ventilation to a target person (abstract, par 0049, fig 4), comprising: accessing a prescription for automatic control of the ventilator system in providing mechanical ventilation to the target person (par 0049 disclosing initial ventilator settings calibrated by medical provider), the prescription comprising: an initial configuration comprising a plurality of initial operational settings of the ventilator system to provide an initial mechanical ventilation to the target person (par 0049 disclosing initial setting, par 0050 disclosing various setting adjustment thus disclosing additional initial settings), a health score formulae (par 0031 discloses “determine lung parameters using various algorithms”, and par 0044 discloses area above a curve thus disclosing an integral formula) representing a quantitative measure of response by which the ventilator determines a current health score (par 0044/0031 disclosing a lung parameter as a health score)according to one or more biometric variables corresponding to the target person (par 0044 discloses determining the lung parameter based on acoustic signals of the target person’s airway openness); an interval setting defining an interval period for evaluating a current health score of the target person (par 0048 discloses "alternatively, the monitor 24 may instruct the acoustic sensor 26 to provide the updated signal in response to the monitor 24 determining that a treatment has been performed (e.g., a threshold time period after the monitor 24 sends control signals, in response to user input)" thus disclosing an interval period of the "threshold time period"); and a selected optimization method by which the ventilator system systematically trials modifications of one or more of said plurality operational settings to improve the current health score (par 0050-0051 disclose an optimization method for updating ventilator settings in order to improv lung parameter/health score), configuring the ventilator system according to the initial configuration (#302 fig 4); operating the ventilator system according to the initial configuration (#302 fig 4); determining a current health score according to the initial configuration (#304 fig 4); during operation of the ventilator system, periodically according to the interval setting, systematically trialing modifications to one or more of the plurality of operational settings according to the selected optimization protocol (#306 fig 4, par 0050 disclosing adjustment, par 0048 disclosing the interval setting); determining an updated health score for the target person corresponding to the trialed operational settings (#310 fig 4); tracking in a memory, the current health score, current operational settings, updated health score and trialed operational settings (par 0032 discloses the use of a memory, par 0051-0052 discloses comparing values thus disclosing storing at least temporarily the values); and upon determining that the updated health score is higher than the current health score (#312 fig 4), reconfiguring the ventilator system according to the trialed operational settings (par 0052); and saving in memory the trialed operational settings as the current operational settings (par 0052 discloses a closed loop thus disclosing trialed settings becoming current settings).
Kimm is silent to minimum and maximum operational boundaries corresponding to each of the plurality of operational settings.
Dong teaches a similar system utilizing minimum and maximum operational boundaries (par 0060 discloses minimum and maximum thresholds for operation such as respiratory rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate minimum and maximum boundaries as taught by Dong for the operational setting of Kimm as doing so can provide safeguard values preventing injury to the user due to extreme values.
Regarding claim 2, modified Kimm discloses the method of claim 1. Kimm further discloses the generated modification is an increase in the predetermined operational setting (par 0050).
Regarding claim 3, modified Kimm discloses the method of claim 1. Kimm further discloses the generated modification is a decrease in the predetermined operational setting (par 0041).
Regarding claim 4, modified Kimm discloses the method of claim 1. Kimm further discloses the initial configuration comprises one or more predetermined operational settings and/or operating modes selected from the group consisting of: Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), Pressure control (PC) (par 0050 “ventilatory pressure”), 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) (par 0050), Pressure Support (PS) (par 0050 “ventilatory pressure”), Respiratory rate (RR) (par 0050 “respiratory frequency”), Tidal volume (VT) (par 0050 “tidal volume”), Inspiratory airflow (V'), FiO2, Inspiratory positive applied pressure (IPAP), Peak inspiratory pressure (PIP), Inspiratory time (par 0050), Inspiratory-to-expiratory ratio (par 0050), Time of pause (par 0050), Trigger sensitivity, Expiratory trigger sensitivity, Transpulmonary driving pressure (∆P) and combinations thereof.
Regarding claim 5, modified Kimm discloses the method of claim 1. Kimm does not expressly disclose the one or more biometric variables are 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), Respiratory Rate Oxygenation (Rox) and combinations thereof. Kimm instead discloses acoustic signals and airway openness.
Dong teaches a similar method where biometric variables are 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), Respiratory Rate Oxygenation (Rox) and combinations thereof (par 0061 disclosing oxygen saturation, end tidal carbon dioxide and blood pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize biometric variables as taught by Dong for the biometric variables of modified Kimm as doing so allows for additional health scores to be calculated.
Regarding claim 6, modified Kimm discloses the method of claim 4. Kimm does not expressly disclose the one or more biometric variables are 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), Respiratory Rate Oxygenation (Rox) and combinations thereof. Kimm instead discloses acoustic signals and airway openness.
Dong teaches a similar method where biometric variables are 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), Respiratory Rate Oxygenation (Rox) and combinations thereof (par 0061 disclosing oxygen saturation, end tidal carbon dioxide and blood pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize biometric variables as taught by Dong for the biometric variables of modified Kimm as doing so allows for additional health scores to be calculated.
Regarding claim 7, modified Kimm discloses the method of claim 5. Dong further discloses one or more biometric variables are further 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, Pressure-time product per minute (PTP), and combinations thereof (par 0007 discloses “patient effort” thus disclosing mechanical energy, and par 0048 disclosing plateau pressure).
Regarding claim 8, modified Kimm discloses the method of claim 6. Dong further discloses one or more biometric variables are further 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, Pressure-time product per minute (PTP), and combinations thereof (par 0007 discloses “patient effort” thus disclosing mechanical energy, and par 0048 disclosing plateau pressure).
Regarding claim 13, modified Kimm discloses the method of claim 1. Kimm further discloses the optimization formulae identifies a plateau condition of decreasing improvement to the current health score and maintains current operational settings in a steady state condition (par 0053).
Regarding claim 14, modified Kimm discloses the method of claim 4. Kimm further discloses the optimization formulae identifies a plateau condition of decreasing improvement to the current health score and maintains current operational settings in a steady state condition (par 0053).
Regarding claim 15, modified Kimm discloses a dynamically configurable ventilator system for providing mechanical ventilation to a target person according to a prescription (abstract), configured to operate in accordance with the method of Claim 1 (see claim 1 above).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over modified Kimm as applied to claims 1, 4 and 5 above, and further in view of O’Brien (US 2017/0188992 A1).
Regarding claim 9, modified Kimm discloses the method of claim 1. Kimm does not expressly disclose the optimization method is selected from the group consisting of: a hill climbing method, a stochastic hill climbing method, two-dimensional hill climbing method, and an n-dimensional hill climbing method, each method optionally including a circuit breaker method.
O’Brien teaches the use of a hill climbing method for optimization (par 0201).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a hill climbing method as taught by O’Brien for the optimization of modified Kimm as a hill climb technique is known for efficiently finding local optima.
Regarding claim 10, modified Kimm discloses the method of claim 4. Kimm does not expressly disclose the optimization method is selected from the group consisting of: a hill climbing method, a stochastic hill climbing method, two-dimensional hill climbing method, and an n-dimensional hill climbing method, each method optionally including a circuit breaker method.
O’Brien teaches the use of a hill climbing method for optimization (par 0201).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a hill climbing method as taught by O’Brien for the optimization of modified Kimm as a hill climb technique is known for efficiently finding local optima.
Regarding claim 11, modified Kimm discloses the method of claim 4. Kimm does not expressly disclose the optimization method is selected from the group consisting of: a hill climbing method, a stochastic hill climbing method, two-dimensional hill climbing method, and an n-dimensional hill climbing method, each method optionally including a circuit breaker method.
O’Brien teaches the use of a hill climbing method for optimization (par 0201).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a hill climbing method as taught by O’Brien for the optimization of modified Kimm as a hill climb technique is known for efficiently finding local optima.
Regarding claim 12, modified Kimm discloses the method of claim 5. Kimm does not expressly disclose the optimization method is selected from the group consisting of: a hill climbing method, a stochastic hill climbing method, two-dimensional hill climbing method, and an n-dimensional hill climbing method, each method optionally including a circuit breaker method.
O’Brien teaches the use of a hill climbing method for optimization (par 0201).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a hill climbing method as taught by O’Brien for the optimization of modified Kimm as a hill climb technique is known for efficiently finding local optima.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Orlovsky US 20230181059 A1 discloses a method of monitoring health utilizing a hill climbing method
Du US 20240316301 A1 discloses a ventilator with a closed loop control system
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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