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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, (i.e., the term “comprises” in line 8 of the abstract). Correction is required. See MPEP § 608.01(b).
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 10-19 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 pre-AIA the applicant regards as the invention.
Regarding claims 10 and 15, the limitation “the external sensor” (claim 10, lines 6 and 13 and claim 15, line 1) lacks proper antecedent basis. Furthermore, it is unclear if the external sensor is the same as or different from the “electrical impedance tomography sensor” being claimed in claim 10, line 3.
Regarding claim 19, the limitation “the external sensor” (lines 7 and 14) lacks proper antecedent basis. Furthermore, it is unclear if the external sensor is the same as or different from the “electrical impedance tomography sensor” being claimed in claim 19, line 4.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-10, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lyon (2023/0364368) in view of Stender (2020/0221970).
Regarding claim 1, Lyon discloses a titration support system (100, fig. 1, paragraphs 0038-0039) for a positive air pressure device (120, fig. 1, paragraphs 0038-0039 and 0043), the system comprising: at least one controller (110 and 112, fig. 1, paragraphs 0038-0040); an external sensor (130, fig. 1) comprising a plurality of sensors (see the plurality of sensors within 130, fig. 1, paragraphs 0056-0057), the external sensor configured to: determine whether the sensor is coupled to the skin of a user (see contact sensors 390 in paragraphs 0116 and 0118, furthermore see PPG sensor 184 that can be worn on the user in paragraph 0081, and see paragraphs 0082-0084, 0095, 0144, 0151, when the controller detects a signal from the sensor, there would be a determination that the sensor is coupled to the skin of a user since the sensors are either in contact or worn by/coupled to the user); establish communication with the at least one controller in response to determining that the external sensor is coupled to the skin of the user (see figs. 1 and 6 and paragraph 0119 and full disclosure, the controller would need to establish communication with the sensors in order to receive the signals coming from the sensors); sense a physiological parameter of the user and form corresponding sensor information; determine whether cardiac output is diminished based upon the sensor information; and transmit the sensor information including an indication of whether the cardiac output is diminished to the at least one controller; the at least one controller configured to: control a flow generator (122 of 120, fig. 1, paragraphs 0052-0053, 0156, 0160-0161, and 0169-0171) to provide therapeutic air assist to the user; receive the sensor information from the external sensor; determine whether the sensor information comprises the indication that the cardiac output is diminished; and begin auto titration to restore the cardiac output to homeopathic levels in response to determining that the cardiac output is diminished (see figs. 1 and 6 and paragraphs 0144-0174, step 601 of the method, the physiological data can be generated and received from, one or more of the sensors 130 which includes heart rate, heart rate variability, cardiac waveform, which are then used to determine a physiological state of the user, and based on the state of the user, the controller would then control the pressure/flow of the flow generator, the physiological data from any sensors that related to measuring the heart or an indirect physiological parameter that can be related to the heart is a cardiac output, the state (emotional score) of the user that is used to determine the therapy being provided would see if the cardiac output is being diminished since the physiological parameters being measured are related to the emotional score that is related to the heart, relatively, furthermore, more direct physiological parameters that are related to the cardiac output includes sensors that measure hear rate, heart rate pattern, heart rate variability and cardiac cycle, cardiac waveform, other cardiac-related parameters (see paragraphs 0058, 0081, 0144 and 00151-0152), and the adjustment made to the flow/pressure (titration) would be to bring the user/patient back to a homeopathic levels, see paragraphs 0091, 0152-0156 and 0168 regarding controlling of the pressure based on the emotional score), but fails to disclose that the external sensor comprises at least an electrical impedance tomography sensor.
However, Stender teaches an external sensor comprises at least an electrical impedance tomography sensor for sensing cardiac parameters (see EIT sensor in paragraphs 0140-0146 and 0169-0174), the EIT sensor is configured to couple to the user (see paragraphs 0033-0034 and 0124, the electrodes are arranged on the thorax and are configured to detect perfusion of the heart and lungs of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of Lyon to have the EIT sensor for measuring physiological parameters including cardiac parameters as taught by Stender for the purpose of providing an additional sensor for determining cardiac parameters that would be useful in determining a physiological state of the user (see paragraphs 0033-0034 and 0140-0146 and 0169-0174 of Stender).
Regarding claim 4, the modified Lyon discloses that the external sensor is further configured to sense sympathetic nervous system activity by measuring electrodermal activity, for corresponding sensor information, and transmit this sensor information to the at least controller (see paragraphs 0083 and 0095 of Lyon, Lyon discloses that ECG signal and/or a PPG signal can be used in concert with a secondary estimate of sympathetic innervation, such as via a galvanic skin response (GSR) sensor, which would measure electrodermal activity, see paragraphs 0038-0040, 0042-0043, 0083-0085 and 0089 of Lyon).
Regarding claim 5, the modified Lyon discloses that the external sensor determines that the cardiac output is diminished when increased sympathetic nervous system activity is detected (see paragraphs 0083 and 0095 of Lyon, Lyon discloses that ECG signal and/or a PPG signal can be used in concert with a secondary estimate of sympathetic innervation, such as via a galvanic skin response (GSR) sensor, which would measure electrodermal activity, see paragraphs 0038-0040, 0042-0043, 0083-0085 and 0089 of Lyon, furthermore, by detecting the sympathetic nervous system activity, the external sensor would be determining cardiac output is being diminished).
Regarding claim 6, the modified Lyon discloses that the external sensor further comprises a galvanic skin response (see paragraphs 0038-0040, 0042-0043, 0083-0085 and 0089 of Lyon).
Regarding claim 7, the modified Lyon discloses that to restore the cardiac output to homeopathic levels, the at least one controller is further configured to control the flow generator to decrease expiratory positive airway pressure by a particular amount every threshold time period until the cardiac output is restored to the homeopathic levels (see paragraphs 0144-0156 and 0168 of Lyon, Lyon discloses that when the emotion score satisfies the predetermine condition, the user is sufficiently relaxed such that the user can fall asleep and the respiratory therapy system 120 can be used and the pressure of the air supplied to the user via the user interface 124 can be increased, and that determining the sleep state, awake, asleep, and/or the sleep stage, step 605 can modify a pressure setting including decreasing the pressure, therefore, there would be a decrease in pressure to bring the user to a desired level, that level is considered as the homeopathic level), but fails to disclose decrease by 1 cm H2O. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify rate of change in pressure of the modified Lyon to be 1 cm H2O for the purpose of providing a workable pressure change value, and since it has been held that discovering an optimum value or workable ranges involves only routine skill in the art. MPEP 2144.05(II).
Regarding claim 8, the modified Lyon discloses that the at least one controller is further configured to determine the homeopathic levels during a titration period (see figs. 1 and 6 of Lyon and paragraphs 0144-0156 and 0168 of Lyon, to adjust pressure of the respiratory device based on physiological parameters would mean that the controller would know the homeopathic levels during the titration period, which is the physiological data and/or the emotional score, see paragraph 0153, the titration period can be interpreted as the period where the sensor senses the physiological parameters and pressure is being actively adjusted).
Regarding claim 9, the modified Lyon discloses that the at least one controller is further configured to determine a maximum pressure Pmax of therapeutic air to assist (see paragraphs 0153 and 0156 and 0168 of Lyon, for the controller to detect what pressure to provide would have a max pressure, whichever the max pressure the controller is providing would be the pressure that is Pmax, this pressure is determined by the controller since the controller would need to know what pressure to provide depending on the physiological parameters).
Regarding claim 10, Lyon discloses a method of providing titration support for titration support system (100, fig. 1, paragraphs 0038-0039) having a positive air pressure device (120, fig. 1, paragraphs 0038-0039 and 0043), the method comprising acts of: determining whether an external sensor (130, fig. 1) comprising a plurality of sensors (see the plurality of sensors within 130, fig. 1, paragraphs 0056-0057) are coupled to the skin of a user (see contact sensors 390 in paragraphs 0116 and 0118, furthermore see PPG sensor 184 that can be worn on the user in paragraph 0081, and see paragraphs 0082-0084, 0095, 0144, 0151, when the controller detects a signal from the sensor, there would be a determination that the sensor is coupled to the skin of a user since the sensors are either in contact or worn by/coupled to the user); establishing communication with at least one controller (110 and 112, fig. 1, paragraphs 0038-0040) in response to determining that the external sensor is coupled to the skin of the user (see figs. 1 and 6 and paragraph 0119 and full disclosure, the controller would need to establish communication with the sensors in order to receive the signals coming from the sensors); sensing a physiological parameter of the user and form corresponding sensor information; determining whether cardiac output is diminished based upon the sensor information; and transmitting the sensor information including an indication of whether the cardiac output is diminished to the at least one controller; controlling a flow generator (122 of 120, fig. 1, paragraphs 0052-0053, 0156, 0160-0161, and 0169-0171) to provide therapeutic air assist to the user; receiving the sensor information from the external sensor; determining whether the sensor information comprises the indication that the cardiac output is diminished; and beginning auto titration to restore the cardiac output to homeopathic levels in response to determining that the cardiac output is diminished (see figs. 1 and 6 and paragraphs 0144-0174, step 601 of the method, the physiological data can be generated and received from, one or more of the sensors 130 which includes heart rate, heart rate variability, cardiac waveform, which are then used to determine a physiological state of the user, and based on the state of the user, the controller would then control the pressure/flow of the flow generator, the physiological data from any sensors that related to measuring the heart or an indirect physiological parameter that can be related to the heart is a cardiac output, the state (emotional score) of the user that is used to determine the therapy being provided would see if the cardiac output is being diminished since the physiological parameters being measured are related to the emotional score that is related to the heart, relatively, furthermore, more direct physiological parameters that are related to the cardiac output includes sensors that measure hear rate, heart rate pattern, heart rate variability and cardiac cycle, cardiac waveform, other cardiac-related parameters (see paragraphs 0058, 0081, 0144 and 00151-0152), and the adjustment made to the flow/pressure (titration) would be to bring the user/patient back to a homeopathic levels, see paragraphs 0091, 0152-0156 and 0168 regarding controlling of the pressure based on the emotional score), but fails to disclose an electrical impedance tomography sensor.
However, Stender teaches an external sensor comprises at least an electrical impedance tomography sensor for sensing cardiac parameters (see EIT sensor in paragraphs 0140-0146 and 0169-0174), the EIT sensor is configured to couple to the user (see paragraphs 0033-0034 and 0124, the electrodes are arranged on the thorax and are configured to detect perfusion of the heart and lungs of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external sensor and method of Lyon to have the EIT sensor for measuring physiological parameters including cardiac parameters as taught by Stender for the purpose of providing an additional sensor for determining cardiac parameters that would be useful in determining a physiological state of the user (see paragraphs 0033-0034 and 0140-0146 and 0169-0174 of Stender).
Regarding claim 13, the modified Lyon discloses sensing sympathetic nervous system activity by measuring electrodermal activity, forming corresponding sensor information, and transmitting this sensor information to the at least one controller (see paragraphs 0083 and 0095 of Lyon, Lyon discloses that ECG signal and/or a PPG signal can be used in concert with a secondary estimate of sympathetic innervation, such as via a galvanic skin response (GSR) sensor, which would measure electrodermal activity, see paragraphs 0038-0040, 0042-0043, 0083-0085 and 0089 of Lyon).
Regarding claim 14, the modified Lyon discloses determining that cardiac output is diminished when increased sympathetic nervous activity is detected (see paragraphs 0083 and 0095 of Lyon, Lyon discloses that ECG signal and/or a PPG signal can be used in concert with a secondary estimate of sympathetic innervation, such as via a galvanic skin response (GSR) sensor, which would measure electrodermal activity, see paragraphs 0038-0040, 0042-0043, 0083-0085 and 0089 of Lyon, furthermore, by detecting the sympathetic nervous system activity, the external sensor would be determining cardiac output is being diminished).
Regarding claim 15, the modified Lyon discloses that the external sensor further comprises a galvanic skin response (see paragraphs 0038-0040, 0042-0043, 0083-0085 and 0089 of Lyon).
Regarding claim 16, the modified Lyon discloses that to restore the cardiac output to homeopathic levels, the at least one controller is further configured to control the flow generator to decrease expiratory positive airway pressure by a particular amount every threshold time period until the cardiac output is restored to the homeopathic levels (see paragraphs 0144-0156 and 0168 of Lyon, Lyon discloses that when the emotion score satisfies the predetermine condition, the user is sufficiently relaxed such that the user can fall asleep and the respiratory therapy system 120 can be used and the pressure of the air supplied to the user via the user interface 124 can be increased, and that determining the sleep state, awake, asleep, and/or the sleep stage, step 605 can modify a pressure setting including decreasing the pressure, therefore, there would be a decrease in pressure to bring the user to a desired level, that level is considered as the homeopathic level), but fails to disclose decrease by 1 cm H2O. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify rate of change in pressure of the modified Lyon to be 1 cm H2O for the purpose of providing a workable pressure change value, and since it has been held that discovering an optimum value or workable ranges involves only routine skill in the art. MPEP 2144.05(II).
Regarding claim 17, the modified Lyon discloses that the at least one controller is further configured to determine the homeopathic levels during a titration period (see figs. 1 and 6 of Lyon and paragraphs 0144-0156 and 0168 of Lyon, to adjust pressure of the respiratory device based on physiological parameters would mean that the controller would know the homeopathic levels during the titration period, which is the physiological data and/or the emotional score, see paragraph 0153, the titration period can be interpreted as the period where the sensor senses the physiological parameters and pressure is being actively adjusted).
Regarding claim 18, the modified Lyon discloses that the at least one controller is further configured to determine a maximum pressure Pmax of therapeutic air to assist (see paragraphs 0153 and 0156 and 0168 of Lyon, for the controller to detect what pressure to provide would have a max pressure, whichever the max pressure the controller is providing would be the pressure that is Pmax, this pressure is determined by the controller since the controller would need to know what pressure to provide depending on the physiological parameters).
Regarding claim 19, Lyon discloses a computer readable non-transitory medium having a computer readable program code for operating on a computer (computer is the computer of 100, which includes control system 110, processor 112, memory device 114, electronic interface 119, user device 170, see paragraphs 0038-0040, the computer readable non-transitory medium is the medium that contains all of the instruction to perform all of the task performed by the sensors and controller as disclosed by Lyon, see full disclosure) for performing a method of providing titration support for titration support system (100, fig. 1, paragraphs 0038-0039) having a positive air pressure device (120, fig. 1, paragraphs 0038-0039 and 0043), the method comprising acts of: determining whether an external sensor (130, fig. 1) comprising a plurality of sensors (see the plurality of sensors within 130, fig. 1, paragraphs 0056-0057) are coupled to the skin of a user (see contact sensors 390 in paragraphs 0116 and 0118, furthermore see PPG sensor 184 that can be worn on the user in paragraph 0081, and see paragraphs 0082-0084, 0095, 0144, 0151, when the controller detects a signal from the sensor, there would be a determination that the sensor is coupled to the skin of a user since the sensors are either in contact or worn by/coupled to the user); establishing communication with at least one controller (110 and 112, fig. 1, paragraphs 0038-0040) in response to determining that the external sensor is coupled to the skin of the user (see figs. 1 and 6 and paragraph 0119 and full disclosure, the controller would need to establish communication with the sensors in order to receive the signals coming from the sensors); sensing a physiological parameter of the user and form corresponding sensor information; determining whether cardiac output is diminished based upon the sensor information; and transmitting the sensor information including an indication of whether the cardiac output is diminished to the at least one controller; controlling a flow generator (122 of 120, fig. 1, paragraphs 0052-0053, 0156, 0160-0161, and 0169-0171) to provide therapeutic air assist to the user; receiving the sensor information from the external sensor; determining whether the sensor information comprises the indication that the cardiac output is diminished; and beginning auto titration to restore the cardiac output to homeopathic levels in response to determining that the cardiac output is diminished (see figs. 1 and 6 and paragraphs 0144-0174, step 601 of the method, the physiological data can be generated and received from, one or more of the sensors 130 which includes heart rate, heart rate variability, cardiac waveform, which are then used to determine a physiological state of the user, and based on the state of the user, the controller would then control the pressure/flow of the flow generator, the physiological data from any sensors that related to measuring the heart or an indirect physiological parameter that can be related to the heart is a cardiac output, the state (emotional score) of the user that is used to determine the therapy being provided would see if the cardiac output is being diminished since the physiological parameters being measured are related to the emotional score that is related to the heart, relatively, furthermore, more direct physiological parameters that are related to the cardiac output includes sensors that measure hear rate, heart rate pattern, heart rate variability and cardiac cycle, cardiac waveform, other cardiac-related parameters (see paragraphs 0058, 0081, 0144 and 00151-0152), and the adjustment made to the flow/pressure (titration) would be to bring the user/patient back to a homeopathic levels, see paragraphs 0091, 0152-0156 and 0168 regarding controlling of the pressure based on the emotional score), but fails to disclose an electrical impedance tomography sensor.
However, Stender teaches an external sensor comprises at least an electrical impedance tomography sensor for sensing cardiac parameters (see EIT sensor in paragraphs 0140-0146 and 0169-0174), the EIT sensor is configured to couple to the user (see paragraphs 0033-0034 and 0124, the electrodes are arranged on the thorax and are configured to detect perfusion of the heart and lungs of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external sensor of Lyon to have the EIT sensor for measuring physiological parameters including cardiac parameters as taught by Stender for the purpose of providing an additional sensor for determining cardiac parameters that would be useful in determining a physiological state of the user (see paragraphs 0033-0034 and 0140-0146 and 0169-0174 of Stender).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lyon (2023/0364368) in view of Stender (2020/0221970) as applied to claim 1 above, and further in view of Pinsky (2014/0107437).
Regarding claim 2, the modified Lyon fail to disclose that the external sensor is further configured to determine mean pulmonary arterial pressure.
However, Pinsky teaches an external sensor is configured to determine mean pulmonary arterial pressure (see paragraphs 0014 and 0027, Pinsky discloses that the physiological parameters can be monitored non-invasively and includes mean pulmonary artery pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external sensor of the modified Lyon to include a sensor for measuring the mean pulmonary arterial pressure as taught by Pinsky for the purpose of providing useful physiological parameters of the patient.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lyon (2023/0364368) in view of Stender (2020/0221970) and Pinsky (2014/0107437) as applied to claim 2 above, and alternatively in view of Radiopaedia (“Mean Pulmonary Arterial Pressure”, 2020).
Regarding claim 3, the modified Lyon discloses that the external sensor determines that the cardiac output is diminished when the mean pulmonary arterial pressure is determined to be equal to or greater than 25 mm Hg (see the modification above with Pinsky, one having ordinary skill in the art would have the external sensor be able to determine a typical pressure range of the mean pulmonary arterial pressure of a patient, which would include 25 mm Hg, therefore, if the patient is experiencing greater than 25 mm Hg, the sensor would be able to determine/capture such pressure, and any pressure that is greater than 25 mm Hg would be an indication of the cardiac output being diminished).
However, if there is any doubt that the modified Lyon’s external sensor is able to determine that the mean pulmonary arterial pressure to be equal to or greater than 25 mm Hg.
Radiopaedia teaches that normal mean pulmonary arterial pressure (MPAP) is less than 20 mm Hg and is considered elevated when MPAP exceeds 25 mm Hg at rest or 30 mm Hg with exertion (see page 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external sensor of the modified Lyon to be able to measure mean pulmonary arterial pressure that exceeds 25 mm Hg and 30 mm Hg as taught by Radiopaedia to be able to detect and determine the patient’s physiological state at all possible mean pulmonary arterial pressure level (see page 1 of Radiopaedia).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lyon (2023/0364368) in view of Stender (2020/0221970) as applied to claim 10 above, and further in view of Pinsky (2014/0107437).
Regarding claim 11, the modified Lyon fail to disclose that the external sensor is further configured to determine mean pulmonary arterial pressure.
However, Pinsky teaches an external sensor is configured to determine mean pulmonary arterial pressure (see paragraphs 0014 and 0027, Pinsky discloses that the physiological parameters can be monitored non-invasively and includes mean pulmonary artery pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external sensor of the modified Lyon to include a sensor for measuring the mean pulmonary arterial pressure as taught by Pinsky for the purpose of providing useful physiological parameters of the patient.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lyon (2023/0364368) in view of Stender (2020/0221970) and Pinsky (2014/0107437) as applied to claim 11 above, and alternatively in view of Radiopaedia (“Mean Pulmonary Arterial Pressure”, 2020).
Regarding claim 12, the modified Lyon discloses that the external sensor determines that the cardiac output is diminished when the mean pulmonary arterial pressure is determined to be equal to or greater than 25 mm Hg (see the modification above with Pinsky, one having ordinary skill in the art would have the external sensor be able to determine a typical pressure range of the mean pulmonary arterial pressure of a patient, which would include 25 mm Hg, therefore, if the patient is experiencing greater than 25 mm Hg, the sensor would be able to determine/capture such pressure, and any pressure that is greater than 25 mm Hg would be an indication of the cardiac output being diminished).
However, if there is any doubt that the modified Lyon’s external sensor is able to determine that the mean pulmonary arterial pressure to be equal to or greater than 25 mm Hg.
Radiopaedia teaches that normal mean pulmonary arterial pressure (MPAP) is less than 20 mm Hg and is considered elevated when MPAP exceeds 25 mm Hg at rest or 30 mm Hg with exertion (see page 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external sensor of the modified Lyon to be able to measure mean pulmonary arterial pressure that exceeds 25 mm Hg and 30 mm Hg as taught by Radiopaedia to be able to detect and determine the patient’s physiological state at all possible mean pulmonary arterial pressure level (see page 1 of Radiopaedia).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Elaz (CN 1871610) is cited to show an EIT sensor.
Mitton (2008/0202525) is cited to show a ventilation parameters comprising an EIT sensor.
Evans (2020/0360690) is cited to show a system comprising a respiratory support and an EIT sensor.
Kremeier (2020/0324067) (2020/0260985) is cited to show a ventilator comprising an EIT sensor for controlling the ventilator.
Stender (2020/0016352) is cited to show a ventilator comprising an EIT sensor.
Tucker (7,338,443) is cited to show a sensor for measuring mean pulmonary arterial pressure.
Sola i Caros (2013/0123617) is cited to show an EIT sensor.
Banner (2007/0000494) is cited to show a ventilator monitoring system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
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, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TU A VO/Primary Examiner, Art Unit 3785
Prosecution Insights