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 .
Status of the Claims
This office action is responsive to the amendment filed on 02/26/2026. As directed by the
amendment: claims 1-2, 13-19, 21-23, 26, and 28 have been amended, claim 27 has been canceled, and claim 30 has been added. Thus, claims 1-3, 13-26, and 28-30 are presently pending in the application.
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, 13, and 21 and dependent claims 2-3, 14-20, 22-26, and 28-30 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.
The processor configured to cause the ventilation device to set the ventilation rate based on the blood oxygenation of the individual in response to identifying the leak between the duct of the ventilation device and the airway is not clearly described in the specification in such a way as to reasonably convey to one skilled in the relevant art. The specification does state in [0033]: “perform an action to adjust a suspected condition of the ventilation device 108, such as a leak”, but says nothing to tie an identification of a leak to set the ventilation rate based on the blood oxygenation and is therefore not described sufficiently.
Claim Interpretation
For examination purposes, Examiner is taking the limitation: a “waveform indicating the partial pressure of CO2” to mean a CO2 waveform that demonstrates, through the values demonstrated by the waveform, the maximal partial pressure of CO2 at the end of an exhaled breath of the patient.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Walker (US 20200253820 A1), Alahmadi (US 20190015614 A1), and Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2).
Regarding claim 1, Silver discloses a system, comprising: a ventilation device (FIG. 1B Airflow from the ventilation apparatus such as bag-valve mask, ventilator; ventilation bag 112 and valve 113 (or via a mechanical ventilator) as set forth in [0101], [0106], and [0123]) comprising a duct configured to be connected to an airway of an individual (FIG. 1B Endotracheal tube 129 with airways sensors 127 are properly placed in the subject's trachea and the subject's lungs are ventilated as set forth in [0123]), the ventilation device being configured to administer positive pressure ventilation (PPV) breaths at a ventilation rate (As set forth in [0019] and [0130]); a CO2 sensor configured to detect a partial pressure of CO2 in the duct (FIG. 1B Airway sensors 127 which may include a capnography sensors to measure gas parameters, such as the concentration and partial pressure of carbon dioxide (CO2) in the respiratory gases of the subject as set forth in [0131]); an airway sensor configured to detect an airway parameter in the duct of the ventilation device, the airway parameter being different than the partial pressure of CO2 (FIG. 1 One or more airway sensors 127 may be employed, for monitoring various characteristics of the air flow within the patient's airway. The airway sensor(s) may include a capnography sensor. For example, the capnography sensor may be equipped to measure gas parameters, such as the concentration and partial pressure of carbon dioxide (CO2) in the respiratory gases of the subject. Signals/data from the capnography sensor may be further processed to determine physiological parameters, such as end-tidal CO2 of the patient. In addition, the airway sensor(s) may include a flow sensor that communicates information related to the subject's inspiratory and expiratory gas flow. The airway sensor(s) may further communicate information related to the concentration and partial pressure of respiratory gases, oxygen and water vapor for example. As discussed herein, the airway sensor(s) may include, for example, capnography for measuring CO2, an oxygen sensor for measuring the amount of oxygen, and/or a flow sensor for measuring the rate and volume of flow within the patient's airway, separate or integrated together as set forth in [0131]); an oxygenation sensor configured to detect a blood oxygenation of the individual (The medical system may include one or more physiological sensors that comprises at least one of: pulse oximeter for obtaining oxygen saturation information from the patient as set forth in [0006]); a display configured to output a first waveform indicating the partial pressure of CO2 (FIG. 15A Graphical user interface window 510 displaying a ETCO2 waveform, 514 as set forth in [0163] and [0233]) during a time interval (Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A; the time interval comprising an inhalation and exhalation phase denoted by the ETCO2 waveform as shown in the annotated figure below) and a second airway parameter that is different than the partial pressure of CO2 during the time interval (The medical system may include visual feedback that includes respiration rate as set forth in [0008]; it would be understood by one of ordinary skill in the art that the parameter could be observed over the same interval as the one where the expiratory CO2 vs. time (ETCO2) is displayed); and a processor (The patient monitoring device further includes at least one processor as set forth in [0005]) configured to: identify a breath event in the first waveform indicating the partial pressure of CO2 in the duct of the ventilation device during the time interval (The expiratory CO2 vs. time (ETCO2) waveform received by the sensors and identified by the processor, shown in FIG. 15 A demonstrates one patient exhalation phase as denoted in the annotated figure below, would be understood by one of ordinary skill in the art that the portion before the presence of a CO2 partial pressure indicates the inhalation phase); identify a leak between the duct of the ventilation device and the airway and in response to identifying the leak between the duct of the ventilation device and the airway: cause the display to output a first alert warning to check for the leak between the duct of the ventilation device and the airway of the individual (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184]); and cause the display to output a second alert indicating that the airway parameter indicated by the second airway parameter data is erroneous (FIG. 1B The medical device 202 monitors for deviations from the prescribed patterns in the rate, in this case respiration rate, and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event the prescribed pattern of ventilation is not followed, which could affect patient safety, are detected as set forth in [0184]).
PNG
media_image1.png
419
689
media_image1.png
Greyscale
Fails to explicitly disclose that the second airway parameter, the respiration rate, is displayed as a waveform.
However, Walker teaches the respiration rate displayed as a waveform (Walker: FIG. 4(a) Graphical trend data for the monitored physiologic parameters such Respiration/Ventilation rate, depicting for each parameter the entire interval that was monitored, which may be selected or determined for only a subset of the overall treatment time interval as set forth in [0095] and [0099]).
Silver and Walker are both considered to be analogous to the claimed invention because they are in the same field of systems directed to the collection and analysis of data related to a patient during an emergency advanced airway management process. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Silver to incorporate the teaching of Walker and include where the respiration rate is displayed as a waveform (Walker: FIG. 4(a) Graphical trend data for the monitored physiologic parameters such Respiration/Ventilation, depicting for each parameter the entire interval that was monitored, which may be selected or determined for only a subset of the overall treatment time interval as set forth in [0095] and [0099]). Doing so would allow for the depiction of the parameter over a given interval.
Silver as modified fails to explicitly disclose that the identification of a leak is by determining that the breath event lacks a plateau phase.
However, Alahmadi teaches the identification of a leak is by determining that the breath event comprises an abnormal capnography waveform, which would indicate the lack of a plateau phase (Alahmadi: As set forth in [0093] and [0111] and shown in FIG. 6L).
Silver and Alahmadi are both considered to be analogous to the claimed invention because they are in the same field of system for monitoring respiratory waveforms. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Silver to incorporate the teaching of Alahmadi and include where the identification of a leak is by determining that the breath event comprises an abnormal capnography waveform, which would indicate the lack of a plateau phase (Alahmadi: As set forth in [0093] and [0111] and shown in FIG. 6L). Doing so would provide early detection of an abnormality in the waveform that could have been overlooked or discovered late while using a mechanical ventilator, the system automatically generating an alert to physicians, as well as providing the ability to process waveform data to provide a technical solution to the technical problem of optimally controlling a ventilator and detecting abnormalities, such as one indicative of a leak (Alahmadi: As set forth in [0111]).
Silver as modified fails to explicitly disclose that determining the breath event lacks a plateau phase is by: determining that a slope of the breath event following a maximum partial pressure of CO2 in the breath event is greater than a first threshold; or determining that a time interval between the maximum partial pressure of CO2 and a local minimum partial pressure of CO2 after the maximum partial pressure of CO2 is greater than a second threshold.
However, The limitation “determining that a slope of the breath event following a maximum partial pressure of CO2 in the breath event is greater than a first threshold; or determining that a time interval between the maximum partial pressure of CO2 and a local minimum partial pressure of CO2 after the maximum partial pressure of CO2 is greater than a second threshold”, as drafted, under its broadest reasonable interpretation, indicates that the inspiratory downstroke of the partial pressure CO2 waveform is not a nearly vertical negative slope. Silver as modified by Alahmadi is able to determine that the breath event comprises an abnormal capnography waveform as set forth in [0093] and [0111], by analyzing the waveform shown in FIG. 6L, the abnormal capnography, used in processing and computing technologies to determine the presence of a leak, shows wherein the inspiratory downstroke of the waveform is not a nearly vertical negative slope as would be present in a normal CO2 waveform without the presence of a leak.
PNG
media_image2.png
358
654
media_image2.png
Greyscale
It is obvious to one of ordinary skill in the art that the abnormal waveform shown in FIG. 6L indicates that slope of the breath event following a maximum partial pressure of CO2 in the breath event would greater than a first threshold, the first threshold being a value representing a nearly vertical negative slope; or determining that a time interval between the maximum partial pressure of CO2 and a local minimum partial pressure of CO2 after the maximum partial pressure of CO2 is greater than a second threshold, the second threshold being a value representing the time frame that indicates a nearly vertical slope of the waveform during the short interval. Therefore, given the ability of the processor of Alahmadi, it would be obvious that a processor would be capable performing the limitations claimed in claim 1.
Silver as modified fails to explicitly disclose, wherein in response to identifying a leak, modifying operation of the ventilator.
However, Jafari teaches wherein in response to identifying a leak, modifying operation of the ventilator (Jafari: As shown in FIG. 3 and set forth in column 5 line 61 – column 9 line 30).
Silver and Jafari are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the ventilator of Silver to incorporate the teaching of Alahmadi and include wherein in response to identifying a leak, modifying operation of the ventilator (Jafari: As shown in FIG. 3 and set forth in column 5 line 61 – column 9 line 30). Doing so would allow for compensation is gas delivery basedo n the detection of the leakage (Jafari: As set forth in column 5 line 61 – column 9 line 30 and FIG. 2 step 312).
Silver as modified fails to explicitly disclose, wherein a ventilation rate is set based on the blood oxygenation of the individual.
However, Tehrani teaches, wherein a ventilation rate is set based on the blood oxygenation of the individual (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP, breathing frequency as set forth in column 3 line 65-column 4 line 43).
Silver and Tehrani are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the ventilator of Silver to incorporate the teaching of Tehrani and include, wherein a ventilation rate is set based on the blood oxygenation of the individual (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP, breathing frequency as set forth in column 3 line 65-column 4 line 43). Doing so would allow for the blood oxygenation of the individual to be used in order to set a ventilation rate (As set forth in column 3 line 65-column 4 line 43). In the case of Silver as modified, a ventilation rate is set based on the blood oxygenation of the individual in response to identifying a leak.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Walker (US 20200253820 A1), Alahmadi (US 20190015614 A1), and Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 1, in further view of Euliano (US 20210016035 A1).
Regarding claim 2, Silver as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Silver as modified further discloses the system, wherein the time interval being a first time interval (Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A; the time interval comprising an inhalation and exhalation phase denoted by the ETCO2 waveform), the breath event being a first breath event, wherein the processor is further configured to: identify breath events comprising the first breath event by analyzing second data, the second data indicating the airway parameter during a third time interval (The expiratory CO2 vs. time (ETCO2) waveform received by the sensors and identified by the processor, shown in FIG. 15 A demonstrates one patient exhalation phase as denoted in the annotated figure; the third time interval being the time wherein the exhalation phase is of the breath event is taking place), the breath events comprising a positive pressure ventilation (PPV) breath event (The medical system may provide a correlation that includes a confirmation that a positive pressure breath given to the patient has reached the patient's lungs as set forth in [0019], [0026], and [0130]); identify a spontaneous breath among the breath events; in response to identifying the spontaneous breath event, cause the display to output an indication of the spontaneous breath event (The medical device may generate an alert informing a caregiver to check the patient, for example, in the even that spontaneously respiration as set forth in [0260]).
Silver as modified fails to explicitly disclose wherein the processor is further configured to: determine that a paralytic has prevented the individual from breathing by analyzing first data, the first data indicating the airway parameter during a second time interval;
However, Walker teaches wherein the processor is further configured to: determine that a paralytic has prevented the individual from breathing (Walker: Spontaneous respiratory activity during positive pressure ventilation could indicate that a patient requires administration of additional medication, such as a sedative and/or analgesic and in the context of an RSI or other advanced airway management process involving administration of a paralytic agent, spontaneous respiratory activity indicates that the paralytic effect is wearing off as set forth in [0194]; therefore, no spontaneous breath activity would indicate the paralytic has prevented the individual from breathing) by analyzing first data (Walker: The proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team that the CO2 waveform exhibited evidence of spontaneous respiratory activity as set forth in [0169]-[0170]), the first data indicating the airway parameter during a second time interval (Walker: The proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team as set forth in [0169]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of Walker and include wherein the processor is further configured to: determine that a paralytic has prevented the individual from breathing (Walker: Spontaneous respiratory activity during positive pressure ventilation could indicate that a patient requires administration of additional medication, such as a sedative and/or analgesic and in the context of an RSI or other advanced airway management process involving administration of a paralytic agent, spontaneous respiratory activity indicates that the paralytic effect is wearing off as set forth in [0194]; therefore, no spontaneous breath activity would indicate the paralytic has prevented the individual from breathing) by analyzing first data (Walker: The proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team that the CO2 waveform exhibited evidence of spontaneous respiratory activity as set forth in [0169]-[0170]), the first data indicating the airway parameter during a second time interval (Walker: The proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team as set forth in [0169]). Doing so would mean that in the context of an RSI (or other advanced airway management process involving administration of a paralytic agent), spontaneous respiratory activity indicates that the paralytic effect is wearing off. Knowledge of this development can thus serve, for example, as a valuable passage-of-time indicator for the medical provider, and may represent an indication for administration of additional medication (Walker: As set forth in [0194]).
Silver as modified fails to explicitly disclose that based on determining that the paralytic has prevented the individual from spontaneously breathing, cause the display to output a recommendation to connect the ventilation device to the airway of the individual.
However, Euliano teaches that based on determining that spontaneous breathing has been prevented, cause the display to output a recommendation to connect the ventilation device to the airway of the individual (Euliano: FIG. 10 Step 1012 provides a recommendation to increase ventilator support as set forth in [0070]; it would be understood by one of ordinary skill in the art that connecting the ventilation device to the airway of the individual would be increasing ventilator support).
Silver and Euliano are both considered to be analogous to the claimed invention because they are in the same field of systems for helping the clinician setup, maintain, and interpret physiological measurements of the patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver wherein when determining that the paralytic has prevented the individual from spontaneously breathing, to incorporate the teaching of Euliano and include that based on determining that spontaneous breathing has been prevented, cause the display to output a recommendation to connect the ventilation device to the airway of the individual (Euliano: FIG. 10 Step 1012 provides a recommendation to increase ventilator support as set forth in [0070]; it would be understood by one of ordinary skill in the art that connecting the ventilation device to the airway of the individual would be increasing ventilator support). Doing so would optimize patient care by alerting for example, a clinician, of a patients need for ventilator support (Euliano: As set forth in [0070]-[0071]), in this case, due to a paralytic being delivered.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Walker (US 20200253820 A1), Alahmadi (US 20190015614 A1), and Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 1, in further view of Helfenbein (US 20180325468 A1) and DeMarzo (US 5031629 A).
Regarding claim 3, Silver as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Silver as modified further discloses the system, the time interval being a first time interval (Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A; the time interval comprising an inhalation and exhalation phase denoted by the ETCO2 waveform), the system further comprising: a blood pressure sensor configured to detect a blood pressure of the individual (Noninvasive blood pressure sensors for obtaining blood pressure of the patient as set forth in [0096]).
Silver as modified fails to explicitly disclose wherein a processor is further configured to: determine a second time interval during which the partial pressure of CO2 is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determine that the individual is being hyperventilated by determining a hyperventilation index proportional to a duration of the second time interval; and in response to determining that the individual is being hyperventilated, cause the blood pressure sensor to detect the blood pressure of the individual.
However, Helfenbein teaches wherein a processor is further configured to: determine a second time interval during which the partial pressure of CO2 is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determine that the individual is being hyperventilated proportional to a duration of the second time interval (Helfenbein: FIG. 1 Respiration monitor 21 may determine a hyperventilating ventilation being applied to the patient whenever respiration monitor 21 concurrently detects the end-tidal carbon dioxide expired by the patient is less than the end-tidal carbon dioxide threshold, a first threshold, AND the respiratory rate of the patient is greater than the respiration rate threshold, a second threshold, for a duration greater than the specified time period or the specified number of respiration cycles as set forth in [0031]; the second time interval being the time interval of the exhalation phase containing the end-tidal carbon dioxide value).
Silver and Helfenbein are both considered to be analogous to the claimed invention because they are in the same field of monitoring devices having a capnography capability employs a ventilation monitoring controller including a capnography monitor and a respiration monitor. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of Helfenbein and include wherein the processor is further configured to: determine a second time interval during which the partial pressure of CO2 is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determine that the individual is being hyperventilated proportional to a duration of the second time interval (Helfenbein: FIG. 1 Respiration monitor 21 may determine a hyperventilating ventilation being applied to the patient whenever respiration monitor 21 concurrently detects the end-tidal carbon dioxide expired by the patient is less than the end-tidal carbon dioxide threshold, a first threshold, AND the respiratory rate of the patient is greater than the respiration rate threshold, a second threshold, for a duration greater than the specified time period or the specified number of respiration cycles as set forth in [0031]; the second time interval being the time interval of the exhalation phase containing the end-tidal carbon dioxide value). Doing so would enable the device to determine hyperventilation of a patient and alert a clinician to avoid the poor outcomes associated with inadvertent hyperventilation (Helfenbein: As set forth in [0002] and [0007]).
Silver as modified fails to explicitly disclose that determining that the individual is being hyperventilated is one of determining a hyperventilation index proportional to a duration of the second time interval.
However, despite the lack of the use of the term “hyperventilation index”, the ability of Silver as modified by Helfenbein performs the identical function specified in the claim in substantially the same way, by determining a hyperventilating ventilation being applied to the patient whenever respiration monitor concurrently detects the end-tidal carbon dioxide expired by the patient is less than (or equal to) the end-tidal carbon dioxide threshold AND the respiratory rate of the patient is greater than (or equal to) the respiration rate threshold for a duration greater than the specified time period or the specified number of respiration cycles (Helfenbein: As set forth in [0031]), and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. Both the processor function of modified Silver and the processor claimed by Applicant are configured to determine a patient is being hyperventilated. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the processor’s determination method shown in the prior art for the corresponding processor method disclosed in the specification. Both would result in the same completion of the same function, determining the patient is being hyperventilated. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Silver as modified to obtain the invention as specified in claim 3 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Silver as modified.
Silver as modified fails to explicitly disclose that in response to determining that the individual is being hyperventilated, cause the blood pressure sensor to detect the blood pressure of the individual.
However, DeMarzo teaches that in response to determining that the individual is being hyperventilated, cause a set of physiological parameters of the individual to be detected, including blood pressure (DeMarzo: A set of measurements are taken when the patient is in a hyperventilated condition including the blood pressure as set forth in Column 5 lines 47-54).
Silver as modified and DeMarzo are both considered to be analogous to the claimed invention because they are in the same field of medical devices capable of measuring parameters including noninvasive blood pressure for monitoring the status of a patient, as well as accounting for a hyperventilated state of a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of DeMarzo and include where in response to determining that the individual is being hyperventilated, cause a set of physiological parameters of the individual to be detected, including blood pressure (DeMarzo: A set of measurements are taken when the patient is in a hyperventilated condition including the blood pressure as set forth in Column 5 lines 47-54). Doing so would account for the change in parameters due to the patient being in a hyperventilated state (DeMarzo: As set forth in Column 5 lines 47-54), providing a more accurate depiction of the state of the user.
Claims 13-14, 19, 21-22, 25, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2).
Regarding claim 13, Silver discloses a medical device (FIG. 1B Medical device 202 as set forth in [0105]), comprising: an airway sensor (FIG. 1B Airway sensors 127 which may include a capnography sensors to measure gas parameters, such as the concentration and partial pressure of carbon dioxide (CO2) in the respiratory gases of the subject as set forth in [0131]) configured to detect an airway parameter in a duct of a ventilation device configured to administer positive pressure ventilation (PPV) breaths to an individual at a ventilation rate (As set forth in [0019] and [0101]); an output device (FIG. 15A Graphical user interface window 510 displaying a ETCO2 waveform, 514 as set forth in [0163] and [0233]); a non-airway sensor configured to detect a non-airway parameter of the individual (The medical system may include one or more physiological sensors that comprises at least one of: pulse oximeter for obtaining oxygen saturation information from the patient as set forth in [0006]); and a processor (The patient monitoring device further includes at least one processor as set forth in [0005]) configured to: determine that a leak is present between the duct of the ventilation device and an airway of the individual by analyzing the airway parameter; in response to determining that the leak is present between the duct of the ventilation device and the airway of the individual: cause the output device to output an alert indicating the leak (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184]).
Silver fails to explicitly disclose, where in response to determining that the leak is present between the duct of the ventilation device and the airway of the individual: cause setting of the ventilation rate administer by the ventilation device based on the non-airway parater.
However, Jafari teaches wherein in response to identifying a leak, modifying operation of the ventilator (Jafari: As shown in FIG. 3 and set forth in column 5 line 61 – column 9 line 30).
Silver and Jafari are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the ventilator of Silver to incorporate the teaching of Alahmadi and include wherein in response to identifying a leak, modifying operation of the ventilator (Jafari: As shown in FIG. 3 and set forth in column 5 line 61 – column 9 line 30). Doing so would allow for compensation is gas delivery basedo n the detection of the leakage (Jafari: As set forth in column 5 line 61 – column 9 line 30 and FIG. 2 step 312).
Silver as modified fails to explicitly disclose, wherein a ventilation rate is set based on the blood oxygenation of the individual.
However, Tehrani teaches, wherein a ventilation rate is set based on the blood oxygenation of the individual (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP, breathing frequency as set forth in column 3 line 65-column 4 line 43).
Silver and Tehrani are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the ventilator of Silver to incorporate the teaching of Tehrani and include, wherein a ventilation rate is set based on the blood oxygenation of the individual (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP, breathing frequency as set forth in column 3 line 65-column 4 line 43). Doing so would allow for the blood oxygenation of the individual to be used in order to set a ventilation rate (As set forth in column 3 line 65-column 4 line 43). In the case of Silver as modified, cause setting of the ventilation rate administer by the ventilation device based on the non-airway parameter, specifically, wherein a ventilation rate is set based on the blood oxygenation of the individual in response to identifying a leak.
Regarding claim 14, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver further discloses the medical device, wherein the airway parameter comprises a partial pressure of CO2 in the duct (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184]; the waveform being the expiratory CO2 vs. time (ETCO2) waveform shown in FIG. 15).
Regarding claim 19, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver as modified by Tehrani further teach, wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by analyzing first data indicating the airway parameter detected by the airway sensor during a first time interval (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184], Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A; the time interval comprising an inhalation and exhalation phase denoted by the ETCO2 waveform), and wherein the processor is further configured to: identify breath events by analyzing second data indicating the airway parameter detected by the sensor during a second time interval (The expiratory CO2 vs. time (ETCO2) waveform received by the sensors and identified by the processor, shown in FIG. 15 A demonstrates one patient exhalation phase as denoted in the annotated figure; the second time interval being the time wherein the exhalation phase is of the breath event is taking place), the breath events comprising a positive pressure ventilation (PPV) breath event (The medical system may provide a correlation that includes a confirmation that a positive pressure breath given to the patient has reached the patient's lungs as set forth in [0019], [0026], and [0130]); identify a spontaneous breath event among the breath events (The medical device may generate an alert informing a caregiver to check the patient, for example, in the even that spontaneously respiration as set forth in [0260]); and in response to identifying the spontaneous breath event, cause adjustment of the ventilation rate (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP and breathing frequency as set forth in column 3 line 65-column 4 line 43; wherein the spontaneous breathing event would be reflected in the sensor data and the breathing frequency would be controlled as a result of the analysis of the data).
Regarding claim 21, Silver discloses a method, comprising: identifying data indicating an airway parameter in a duct of a ventilation device configured to administer positive pressure (PPV) breaths to an individual at a ventilation rate (FIG. 1B Airway sensors 127 which may include a capnography sensors to measure gas parameters, such as the concentration and partial pressure of carbon dioxide (CO2) in the respiratory gases of the subject as set forth in [0131]; receiving a positive pressure ventilation (PPV) from a ventilation device (As set forth in [0019] and [0101]); determining that a leak is present between the duct of the ventilation device and an airway of the individual by analyzing the airway parameter; and in response to determining that the leak is present between the duct of the ventilation device and the airway of the individual: causing an output device to output an alert indicating the leak (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184]).
Silver fails to explicitly disclose, where in response to determining that the leak is present between the duct of the ventilation device and the airway of the individual: cause setting of the ventilation rate administer by the ventilation device based on the non-airway parameter.
However, Jafari teaches wherein in response to identifying a leak, modifying operation of the ventilator (Jafari: As shown in FIG. 3 and set forth in column 5 line 61 – column 9 line 30).
Silver and Jafari are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the ventilator of Silver to incorporate the teaching of Alahmadi and include wherein in response to identifying a leak, modifying operation of the ventilator (Jafari: As shown in FIG. 3 and set forth in column 5 line 61 – column 9 line 30). Doing so would allow for compensation is gas delivery basedo n the detection of the leakage (Jafari: As set forth in column 5 line 61 – column 9 line 30 and FIG. 2 step 312).
Silver as modified fails to explicitly disclose, wherein a ventilation rate is set based on a non-airway parameter of the individual.
However, Tehrani teaches, wherein a ventilation rate is set based on a non-airway parameter of the individual, and in this case, the blood oxygenation of the individual (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP, breathing frequency as set forth in column 3 line 65-column 4 line 43).
Silver and Tehrani are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operation of the ventilator of Silver to incorporate the teaching of Tehrani and include, wherein a ventilation rate is set based on the blood oxygenation of the individual (Tehrani: FIG. 1 The digital processor 10 includes a programmable controller coupled to receive the outputs of 8 bit A/D converters 12, 14 and 16 as shown. The A/D converters 18 and 20 are each a single 8 bit A/D converter. The A/D converter unit 22 is an A/D board containing three 8 bit A/D converters. The inputs 24, 26, and 28 of the A/Ds are from an oxygen sensor, preferably a pulse oximeter, 30, a CO.sub.2 sensor, such as a transcutaneous monitor or preferably a capnograph, 32, and a lung mechanics calculator and PV monitor, 34; The mechanical ventilator 56 receives the control signals 48 from the Signal Generator Circuit 46. These consist of signals to control PEEP, breathing frequency as set forth in column 3 line 65-column 4 line 43). Doing so would allow for the blood oxygenation of the individual to be used in order to set a ventilation rate (As set forth in column 3 line 65-column 4 line 43). In the case of Silver as modified, cause setting of the ventilation rate administer by the ventilation device based on the non-airway parameter, specifically, wherein a ventilation rate is set based on the blood oxygenation of the individual in response to identifying a leak.
Regarding claim 22, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver further discloses the method, wherein the airway parameter comprises an end tidal CO2 (FIG. 1B Airway sensors 127 which may include a capnography sensors to measure gas parameters, such as the concentration and partial pressure of carbon dioxide (CO2) in the respiratory gases of the subject as set forth in [0131]; FIG. 15A Graphical user interface window 510 displaying a ETCO2 waveform, 514 as set forth in [0163] and [0233]; Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096]).
Regarding claim 25, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver further discloses the method, the data being first data indicating the airway parameter during a first time interval (Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A; the time interval comprising an inhalation and exhalation phase denoted by the ETCO2 waveform), wherein the method further comprises: identifying breath events by analyzing second data indicating the airway parameter during a second time interval (The expiratory CO2 vs. time (ETCO2) waveform received by the sensors and identified by the processor, shown in FIG. 15 A demonstrates one patient exhalation phase as denoted in the annotated figure; the second time interval being the time wherein the exhalation phase is of the breath event is taking place), the breath events comprising a positive pressure ventilation (PPV) breath event (The medical system may provide a correlation that includes a confirmation that a positive pressure breath given to the patient has reached the patient's lungs as set forth in [0019], [0026], and [0130]); identifying a spontaneous breath event among the breath events; and in response to identifying the spontaneous breath event, outputting an indication of the spontaneous breath event (The medical device may generate an alert informing a caregiver to check the patient, for example, in the even that spontaneously respiration as set forth in [0260]).
Regarding claim 30, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver further discloses, wherein the non-airway parameter comprises a blood oxygenation of the individual (The medical system may include one or more physiological sensors that comprises at least one of: pulse oximeter for obtaining oxygen saturation information from the patient as set forth in [0006]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 13, in view of Alahmadi (US 20190015614 A1).
Regarding claim 15, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver further discloses the medical device, wherein the airway parameter comprises a partial pressure of CO2 in the duct (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184]; the waveform being the expiratory CO2 vs. time (ETCO2) waveform shown in FIG. 15, the end-tidal carbon dioxide (ETCO2) waveform demonstrating the maximal partial pressure of CO2 at the end of an exhaled breath of the patient as set forth in [0131]).
Silver as modified fails to explicitly disclose wherein the processor is configured to determine that the leak is present between the duct of the ventilation device and the airway of the individual by determining that the airway parameter lacks a plateau phase.
However, Alahmadi teaches wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the airway parameter lacks a plateau phase (Alahmadi: As set forth in [0093] and [0111] and shown in FIG. 6L).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of Alahmadi and include wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the airway parameter lacks a plateau phase (Alahmadi: As set forth in [0093] and [0111] and shown in FIG. 6L). Doing so would provide early detection of an abnormality in the waveform that could have been overlooked or discovered late while using a mechanical ventilator, the system automatically generating an alert to physicians, as well as providing the ability to process waveform data to provide a technical solution to the technical problem of optimally controlling a ventilator and detecting abnormalities, such as one indicative of a leak (Alahmadi: As set forth in [0111]).
Silver as modified fails to explicitly disclose that determining the breath event lacks a plateau phase is by: identifying a breath event in a waveform of the airway parameter, the breath event comprising an inspiratory phase and an expiratory phase; identifying a segment of the breath event defined after a local maximum of the airway parameter in the breath event and defined before a local minimum of the airway parameter in the breath event; and determining that a slope of the segment is greater than a threshold.
However, the limitation “identifying a breath event in a waveform of the airway parameter, the breath event comprising an inspiratory phase and an expiratory phase; identifying a segment of the breath event defined after a local maximum of the airway parameter in the breath event and defined before a local minimum of the airway parameter in the breath event; and determining that a slope of the segment is greater than a threshold”, as drafted, under its broadest reasonable interpretation, indicates that the inspiratory downstroke of the partial pressure CO2 waveform is not a nearly vertical negative slope. Silver as modified by Alahmadi is able to determine that the breath event comprises an abnormal capnography waveform as set forth in [0093] and [0111], by analyzing the waveform shown in FIG. 6L, the abnormal capnography, used in processing and computing technologies to determine the presence of a leak, shows wherein the inspiratory downstroke of the waveform is not a nearly vertical negative slope as would be present in a normal CO2 waveform without the presence of a leak.
PNG
media_image2.png
358
654
media_image2.png
Greyscale
It is obvious to one of ordinary skill in the art that the abnormal waveform shown in FIG. 6L indicates that slope of the breath event following a local maximum of the airway parameter in the breath event and defined before a local minimum of the airway parameter in the breath event is greater than a threshold, the threshold being a value representing the time frame that indicates a nearly vertical slope of the waveform during the short interval. Therefore, given the ability of the processor of Alahmadi, it would be obvious that a processor would be capable performing the limitations claimed in claim 15.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 13, in view of Kelly (US 7040319 B1).
Regarding claim 16, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver fails to explicitly disclose wherein the airway parameter comprises a partial pressure of 02 in the duct, and wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the partial pressure of O2 in the duct is below a threshold.
However, Kelly teaches wherein the airway parameter used to detect a leak comprises a partial pressure of 02 in the airway of the individual, and wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the airway parameter is below a threshold (Kelly: FIG.1 The hypoxia warning device 110 is configured to detect and monitor the oxygen partial pressure directly within the air mask 100. By measuring the atmosphere directly within the air mask, the hypoxia warning device 110 can detect malfunctions such as a leak in the air hose connecting the oxygen system and the air mask 100, if the oxygen partial pressure falls below a certain acceptable level, the hypoxia warning device 110 is configured to activate a vibrator that vibrates the air mask 100, or portions thereof, to warn the user that a potentially hypoxic condition exists as set forth in column 5 lines 22-32).
Silver and Kelly are both considered to be analogous to the claimed invention because they are in the same field of apparatuses involving the delivery of gas to a patent disclosed for monitoring parameters for providing a tactile warning to the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of Kelly and include wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the airway parameter is below a threshold (Kelly: FIG.1 The hypoxia warning device 110 is configured to detect and monitor the oxygen partial pressure directly within the air mask 100. By measuring the atmosphere directly within the air mask, the hypoxia warning device 110 can detect malfunctions such as a leak in the air hose connecting the oxygen system and the air mask 100, if the oxygen partial pressure falls below a certain acceptable level, the hypoxia warning device 110 is configured to activate a vibrator that vibrates the air mask 100, or portions thereof, to warn the user that a potentially hypoxic condition exists as set forth in column 5 lines 22-32). Doing so would warn the user that a potentially hypoxic condition exists due to a leak (Kelly: As set forth in column 5 lines 22-32).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 13, in view of Heinonen (US 20100078018 A1).
Regarding claim 17, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver fails to explicitly disclose, wherein the airway parameter comprises a volume of air received from the airway of the individual, and wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the volume of air received from the airway of the individual is lower than a volume of air output by the ventilation device.
However, Heinonen teaches wherein the airway parameter comprises a volume of air received from the airway of the individual, and wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the airway parameter is lower than a volume of air output by the ventilation device (Heinonen: FIG. 1 Leak analyzer 40 is adapted to determine both the gas volume added and the gas volume removed during the breath cycle and is adapted to compare these determined gas volumes to each other and the change in the gas volume stored in the system and is adapted to determine based on the comparison the system leakage, the system is leaking in case the gas volume added and the gas volume removed are substantially non-equal, which would be understood by one of ordinary skill in the art to mean volume removed during the breathing cycle is lower than a volume of air output by the device, the system is leaking in the case that the gas volume added is substantially larger than the gas volume removed as set forth in [0038]).
Silver and Heinonen are both considered to be analogous to the claimed invention because they are in the same field of medical devices with an arrangement for detecting a leak in the system. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver, in terms of the air/gas supplied to the patient, to incorporate the teaching of Heinonen and include wherein the airway parameter comprises a volume of air in the airway of the individual, and wherein the processor is configured to determine that the leak is present between the ventilation device and the airway of the individual by determining that the airway parameter is lower than a volume of air output by the ventilation device (Heinonen: FIG. 1 Leak analyzer 40 is adapted to determine both the gas volume added and the gas volume removed during the breath cycle and is adapted to compare these determined gas volumes to each other and the change in the gas volume stored in the system and is adapted to determine based on the comparison the system leakage, the system is leaking in case the gas volume added and the gas volume removed are substantially non-equal, which would be understood by one of ordinary skill in the art to mean volume removed during the breathing cycle is lower than a volume of air output by the device, the system is leaking in the case that the gas volume added is substantially larger than the gas volume removed as set forth in [0038]). Doing so would enable the device to determine a leak based off of the difference in gas between the volume supplied by the device and the volume in the airway of the individual (Heinonen: As set forth in [0038]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 13, in view of Walker (US 20200253820 A1) and Euliano (US 20210016035 A1).
Regarding claim 18, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver further discloses the medical device, wherein the processor is configured to determine that the leak is present between the duct of the ventilation device and the airway of the individual by analyzing first data indicating the airway parameter detected by the airway sensor during a first time interval (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184], Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A; the time interval comprising an inhalation and exhalation phase denoted by the ETCO2 waveform).
Silver fails to explicitly disclose wherein the processor is further configured to: determine that a medication has prevented the individual from breathing by analyzing second data indicating the airway parameter detected by the sensor during a second time interval; and based on determining that the medication has prevented the individual from spontaneously breathing, cause the ventilation device to administer the PPV breaths.
However, Walker teaches wherein the processor is further configured to: determine that a medication has prevented the individual from breathing (Walker: Spontaneous respiratory activity during positive pressure ventilation could indicate that a patient requires administration of additional medication, such as a sedative and/or analgesic and in the context of an RSI or other advanced airway management process involving administration of a paralytic agent, spontaneous respiratory activity indicates that the paralytic effect is wearing off as set forth in [0194]; therefore, no spontaneous breath activity would indicate the paralytic has prevented the individual from breathing) by analyzing second data indicating the airway parameter detected by the sensor during a second time interval (Walker: The proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team that the CO2 waveform exhibited evidence of spontaneous respiratory activity as set forth in [0169]-[0170]; the second time interval being the proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team as set forth in [0169]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of Walker and include wherein the processor is further configured to: determine that a medication has prevented the individual from breathing (Walker: Spontaneous respiratory activity during positive pressure ventilation could indicate that a patient requires administration of additional medication, such as a sedative and/or analgesic and in the context of an RSI or other advanced airway management process involving administration of a paralytic agent, spontaneous respiratory activity indicates that the paralytic effect is wearing off as set forth in [0194]; therefore, no spontaneous breath activity would indicate the paralytic has prevented the individual from breathing) by analyzing second data indicating the airway parameter detected by the sensor during a second time interval (Walker: The proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team that the CO2 waveform exhibited evidence of spontaneous respiratory activity as set forth in [0169]-[0170]; the second time interval being the proportion of time between the time of successful placement of an advanced airway and the time of hand-off of the patient to the next care location or team as set forth in [0169]). Doing so would mean that in the context of an RSI (or other advanced airway management process involving administration of a paralytic agent), spontaneous respiratory activity indicates that the paralytic effect is wearing off. Knowledge of this development can thus serve, for example, as a valuable passage-of-time indicator for the medical provider, and may represent an indication for administration of additional medication (Walker: As set forth in [0194]).
Silver as modified fails to explicitly disclose that based on determining that the paralytic has prevented the individual from spontaneously breathing, cause the ventilation device to administer the PPV breaths.
However, Euliano teaches that based on determining that spontaneous breathing has been prevented, cause the ventilation device to administer the PPV breaths (Euliano: FIG. 10 Step 1012 provides a recommendation or automatically implements an increase in ventilator support as set forth in [0070], which would be the PPV breaths of Silver as modified).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver wherein when determining that the paralytic has prevented the individual from spontaneously breathing, to incorporate the teaching of Euliano and include that based on determining that spontaneous breathing has been prevented, cause the ventilation device to administer the PPV breaths (Euliano: FIG. 10 Step 1012 provides a recommendation or automatically implements an increase in ventilator support as set forth in [0070], which would be the PPV breaths of Silver as modified). Doing so would optimize patient care by alerting for example, a clinician, of a patients need for ventilator support and providing an automatically implemented increase in ventilator support (Euliano: As set forth in [0070]-[0071]), in this case, due to a paralytic being delivered.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 13, in view of Heinonen (US 20100078018 A1).
Regarding claim 20, Silver discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Silver further discloses the medical device, further comprising: a blood pressure sensor configured to detect a blood pressure of the individual (Noninvasive blood pressure sensors for obtaining blood pressure of the patient as set forth in [0096]), wherein the airway parameter comprises an end tidal CO2 (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184], Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A).
Silver fails to explicitly disclose wherein a processor is further configured to: determine a time interval during which the airway parameter is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determine that the individual is being hyperventilated by determining a hyperventilation index using the time interval; and in response to determining that the individual is being hyperventilated, cause the blood pressure sensor to detect the blood pressure of the individual.
However, Helfenbein teaches wherein a processor is further configured to: determine a time interval during which the airway parameter is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determine that the individual is being hyperventilated by determining hyperventilation over the time interval; and in response to determining that the individual is being hyperventilated, cause the blood pressure sensor to detect the blood pressure of the individual (Helfenbein: FIG. 1 Respiration monitor 21 may determine a hyperventilating ventilation being applied to the patient whenever respiration monitor 21 concurrently detects the end-tidal carbon dioxide expired by the patient is less than the end-tidal carbon dioxide threshold, a first threshold, AND the respiratory rate of the patient is greater than the respiration rate threshold, a second threshold, for a duration greater than the specified time period or the specified number of respiration cycles as set forth in [0031]; the time interval being the interval of time of the exhalation phase containing the end-tidal carbon dioxide value).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of Helfenbein and include wherein the processor is further configured to: determine a time interval during which the airway parameter is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determine that the individual is being hyperventilated by determining hyperventilation over the time interval; and in response to determining that the individual is being hyperventilated, cause the blood pressure sensor to detect the blood pressure of the individual (Helfenbein: FIG. 1 Respiration monitor 21 may determine a hyperventilating ventilation being applied to the patient whenever respiration monitor 21 concurrently detects the end-tidal carbon dioxide expired by the patient is less than the end-tidal carbon dioxide threshold, a first threshold, AND the respiratory rate of the patient is greater than the respiration rate threshold, a second threshold, for a duration greater than the specified time period or the specified number of respiration cycles as set forth in [0031]; the time interval being the interval of time of the exhalation phase containing the end-tidal carbon dioxide value). Doing so would enable the device to determine hyperventilation of a patient and alert a clinician to avoid the poor outcomes associated with inadvertent hyperventilation (Helfenbein: As set forth in [0002] and [0007]).
Silver as modified fails to explicitly disclose that determining that the individual is being hyperventilated by determining a hyperventilation index using the time interval.
However, despite the lack of the use of the term “hyperventilation index”, the ability of Silver as modified by Helfenbein performs the identical function specified in the claim in substantially the same way, by determining a hyperventilating ventilation being applied to the patient whenever respiration monitor concurrently detects the end-tidal carbon dioxide expired by the patient is less than (or equal to) the end-tidal carbon dioxide threshold AND the respiratory rate of the patient is greater than (or equal to) the respiration rate threshold for a duration greater than the specified time period or the specified number of respiration cycles (Helfenbein: As set forth in [0031]), and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. Both the processor function of modified Silver and the processor claimed by Applicant are configured to determine a patient is being hyperventilated. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the processor’s determination method shown in the prior art for the corresponding processor method disclosed in the specification. Both would result in the same completion of the same function, determining the patient is being hyperventilated. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Silver as modified to obtain the invention as specified in claim 20 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Silver as modified.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 21, in view of Wondka (US 20100083968 A1).
Regarding claim 23, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver further discloses the method, wherein the airway parameter being a first airway parameter (FIG. 1B Airway sensors 127 which may include a capnography sensor to measure gas parameters, such as the partial pressure of carbon dioxide (CO2) in the respiratory gases of the subject as set forth in [0131]), the method further comprising: identifying data indicating a second airway parameter in the duct of the ventilation device (The medical system may include visual feedback that includes respiration rate as set forth in [0008])
Silver fails to explicitly disclose generating data indicating a corrected airway parameter by decreasing a value of the data indicating the second airway parameter; and outputting the data indicating the corrected airway parameter.
However, Wondka teaches decreasing a value of the data indicating the second airway parameter (Wondka: The respiration rate may be a measure of consecutive breaths over the predetermined time, and ventilation is adjusted after a predetermined number of breaths at a predetermined rate as set forth in [0013]; adjustment of the ventilation would involve decreasing the respiration rate as needed according to the measurements), which would in turn generate data indicating a corrected airway parameter by and outputting the data indicating the corrected airway parameter (Wondka: The ventilation therapy uses biofeedback control of ventilation as set forth in [0003] and [0049]).
Silver and Wondka are both considered to be analogous to the claimed invention because they are in the same field of respiratory devices that may monitor the health status of the patient and process this information in order assess the status of a patient and the degree of success of the ventilation therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Silver to incorporate the teaching of Wondka and include decreasing a value of the data indicating the second airway parameter (Wondka: The respiration rate may be a measure of consecutive breaths over the predetermined time, and ventilation is adjusted after a predetermined number of breaths at a predetermined rate as set forth in [0013]; adjustment of the ventilation would involve decreasing the respiration rate as needed according to the measurements), which would in turn generate data indicating a corrected airway parameter by and outputting the data indicating the corrected airway parameter (Wondka: The ventilation therapy uses biofeedback control of ventilation as set forth in [0003] and [0049]). Doing so would optimize ventilation parameters to improve the health of the patient (Wondka: As set forth in the Abstract).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 21, in view of Helfenbein (US 20180325468 A1) and DeMarzo (US 5031629 A).
Regarding claim 24, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver further disclose the method, wherein the airway parameter comprises an end tidal CO2 (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184], Capnography sensor to measure expiratory CO2, typically presented as a waveform of expiratory CO2 vs. time (ETCO2) as set forth in [0096] and shown in FIG. 15A).
Silver fails to explicitly disclose the method further comprising: determining a time interval during which the airway parameter is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determining that the individual is being hyperventilated by determining hyperventilation over the time interval
However, Helfenbein teaches a method further comprising: determining a time interval during which the airway parameter is less than a first threshold and a respiration rate of the individual is greater than a second threshold; determining that the individual is being hyperventilated by determining hyperventilation over the time interval (Helfenbein: FIG. 1 Respiration monitor 21 may determine a hyperventilating ventilation being applied to the patient whenever respiration monitor 21 concurrently detects the end-tidal carbon dioxide expired by the patient is less than the end-tidal carbon dioxide threshold, a first threshold, AND the respiratory rate of the patient is greater than the respiration rate threshold, a second threshold, for a duration greater than the specified time period or the specified number of respiration cycles as set forth in [0031]; the time interval being the time interval of the exhalation phase containing the end-tidal carbon dioxide value).
Silver as modified fails to explicitly disclose that determining that the individual is being hyperventilated is one of determining a hyperventilation index for the timer interval.
However, despite the lack of the use of the term “hyperventilation index”, the ability of Silver as modified by Helfenbein performs the identical function specified in the claim in substantially the same way, by determining a hyperventilating ventilation being applied to the patient whenever respiration monitor concurrently detects the end-tidal carbon dioxide expired by the patient is less than (or equal to) the end-tidal carbon dioxide threshold AND the respiratory rate of the patient is greater than (or equal to) the respiration rate threshold for a duration greater than the specified time period or the specified number of respiration cycles (Helfenbein: As set forth in [0031]), and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. Both the processor function of modified Silver and the processor claimed by Applicant are configured to determine a patient is being hyperventilated. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the processor’s determination method shown in the prior art for the corresponding processor method disclosed in the specification. Both would result in the same completion of the same function, determining the patient is being hyperventilated. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Silver as modified to obtain the invention as specified in claim 24 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Silver as modified.
Silver as modified fails to explicitly disclose that in response to determining that the individual is being hyperventilated, causing a blood pressure sensor to detect the blood pressure of the individual.
However, DeMarzo teaches that in response to determining that the individual is being hyperventilated, cause a set of physiological parameters of the individual to be detected, including blood pressure (DeMarzo: A set of measurements are taken when the patient is in a hyperventilated condition including the blood pressure as set forth in Column 5 lines 47-54).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Silver to incorporate the teaching of DeMarzo and include where in response to determining that the individual is being hyperventilated, cause a set of physiological parameters of the individual to be detected, including blood pressure (DeMarzo: A set of measurements are taken when the patient is in a hyperventilated condition including the blood pressure as set forth in Column 5 lines 47-54). Doing so would account for the change in parameters due to the patient being in a hyperventilated state (DeMarzo: As set forth in Column 5 lines 47-54), providing a more accurate depiction of the state of the user.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 21, in view of Alahmadi (US 20190015614 A1).
Regarding claim 26, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver fails to explicitly disclose the method, wherein determining that the leak is present between the ventilation device and the airway of the individual comprises determining that the airway parameter lacks a plateau phase.
However, Alahmadi teaches the identification of a leak is by determining that the breath event comprises an abnormal capnography waveform, which would indicate the lack of a plateau phase (Alahmadi: As set forth in [0093] and [0111] and shown in FIG. 6L).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Silver to incorporate the teaching of Alahmadi and include where the identification of a leak is by determining that the breath event comprises an abnormal capnography waveform, which would indicate the lack of a plateau phase (Alahmadi: As set forth in [0093] and [0111] and shown in FIG. 6L). Doing so would provide early detection of an abnormality in the waveform that could have been overlooked or discovered late while using a mechanical ventilator, the system automatically generating an alert to physicians, as well as providing the ability to process waveform data to provide a technical solution to the technical problem of optimally controlling a ventilator and detecting abnormalities, such as one indicative of a leak (Alahmadi: As set forth in [0111]).
Silver as modified fails to explicitly disclose that determining the breath event lacks a plateau phase is by: identifying a breath event in a waveform of the airway parameter, the breath event comprising an inspiratory phase and an expiratory phase; identifying a segment of the breath event defined after a local maximum of the airway parameter in the breath event and defined before a local minimum of the airway parameter in the breath event; and determining that a time interval of the segment is greater than a threshold.
However, the limitation “identifyinq a breath event in a waveform of the airway parameter, the breath event comprising an inspiratory phase and an expiratory phase; identifying a segment of the breath event defined after a local maximum of the airway parameter in the breath event and defined before a local minimum of the airway parameter in the breath event; and determining that a time interval of the segment is greater than a threshold” as drafted, under its broadest reasonable interpretation, indicates that the inspiratory downstroke of the partial pressure CO2 waveform is not a nearly vertical negative slope. Silver as modified by Alahmadi is able to determine that the breath event comprises an abnormal capnography waveform as set forth in [0093] and [0111], by analyzing the waveform shown in FIG. 6L, the abnormal capnography, used in processing and computing technologies to determine the presence of a leak, shows wherein the inspiratory downstroke of the waveform is not a nearly vertical negative slope as would be present in a normal CO2 waveform without the presence of a leak.
PNG
media_image2.png
358
654
media_image2.png
Greyscale
It is obvious to one of ordinary skill in the art that the abnormal waveform shown in FIG. 6L indicates that the time interval of the segment of the breath event following a local maximum of the airway parameter in the breath event and defined before a local minimum of the airway parameter in the breath event is greater than a threshold, the threshold being a value representing the time frame that indicates a nearly vertical slope of the waveform during the short interval. Therefore, given the ability of the processor of Alahmadi, it would be obvious that a processor would be capable performing the limitations claimed in claim 26.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 21, in view of Heinonen (US 20100078018 A1).
Regarding claim 28, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver fails to explicitly disclose the method, wherein the airway parameter comprises a volume of air received from the airway of the individual, and wherein determining that the leak is present between the ventilation device and the airway of the individual comprises determining that the airway parameter is lower than a volume of air output by the ventilation device.
However, Heinonen teaches wherein the airway parameter comprises a volume of air in the airway of the individual, and wherein determining that the leak is present between the ventilation device and the airway of the individual comprises determining that the airway parameter is lower than a volume of air output by the ventilation device(Heinonen: FIG. 1 Leak analyzer 40 is adapted to determine both the gas volume added and the gas volume removed during the breath cycle and is adapted to compare these determined gas volumes to each other and the change in the gas volume stored in the system and is adapted to determine based on the comparison the system leakage, the system is leaking in case the gas volume added and the gas volume removed are substantially non-equal, which would be understood by one of ordinary skill in the art to mean volume removed during the breathing cycle is lower than a volume of air output by the device, the system is leaking in the case that the gas volume added is substantially larger than the gas volume removed as set forth in [0038]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Silver, in terms of the air/gas supplied to the patient, to incorporate the teaching of Heinonen and include wherein the airway parameter comprises a volume of air in the airway of the individual, and wherein determining that the leak is present between the ventilation device and the airway of the individual comprises determining that the airway parameter is lower than a volume of air output by the ventilation device(Heinonen: FIG. 1 Leak analyzer 40 is adapted to determine both the gas volume added and the gas volume removed during the breath cycle and is adapted to compare these determined gas volumes to each other and the change in the gas volume stored in the system and is adapted to determine based on the comparison the system leakage, the system is leaking in case the gas volume added and the gas volume removed are substantially non-equal, which would be understood by one of ordinary skill in the art to mean volume removed during the breathing cycle is lower than a volume of air output by the device, the system is leaking in the case that the gas volume added is substantially larger than the gas volume removed as set forth in [0038]). Doing so would provide the system with an additional leak determining airway parameter and enable the device to determine a leak based off of the difference in gas between the volume supplied by the device and the volume in the airway of the individual (Heinonen: As set forth in [0038]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20190224434 A1) in view of Tehrani (US 7802571 B2) in further view of Jafari (US 10207069 B2) as applied to claim 21.
Regarding claim 29, Silver discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Silver further discloses the method, wherein causing the output device to output the alert indicating the leak (FIG. 1B Medical device 202 monitors for deviations from the prescribed patterns in the waveform and an alarm or other feedback may be triggered to alert or otherwise better guide the user in the event of a mask leak, which could affect patient safety, are detected as set forth in [0184])
Silver fails to explicitly disclose the alert indicating the leak comprises causing the output device to: output an instruction to connect the ventilation device to the airway of the individual.
However, the ability of the method of Silver teaching an alarm or other feedback that may be triggered to alert or otherwise better guide the user in the event of a mask leak, which would be readily understood by one of ordinary skill in the art to include an instruction to connect the ventilation device to the airway of the individual in order to fix a leak in the system. Doing so would improve patient safety (As set forth in [0184]).
Response to Arguments
The rejections under 35 U.S.C. 101 have been withdrawn given the amendments to the claims.
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive.
New grounds of rejection are made above in response to the amendments to the claims.
Applicant argues that no part of Alahmadi teaches the lack of a plateau phase in the partial pressure of CO2 in a breath event.
However, as stated in the previous Office Action and discussed during the interview, that given paragraphs [0093], [0111], as well as paragraphs [0058] and [0063] that, while the language they're using to refer to the graph is "abnormal", and not specifically that there is "no plateau phase", it's clear that that would be the abnormality in the graph as processed by the system of Alahmadi, given that the methodology they're using while processing the waveform includes where they determine a slope based on a segment of a waveform and compare it with pre-stored slopes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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, Kendra Carter can be reached at (571) 272-9034. 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.
/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights