DETAILED ACTION
This office action is in response to the amendment filed 8/1/2025. As directed by the amendment, claims 41, 46, and 56 have been amended, claims 1-40 claims have been cancelled and no claims have been newly added. Thus, claims 41-60 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 8/1/2025 has been entered.
Drawings
The drawings are objected to because the unlabeled rectangular box(es) shown in the drawings should be provided with descriptive text labels. In figures 2-3, unlabeled box elements should be provided with descriptive text labels. For clarification, “conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box)”. See 37 CFR 1.83(a) and 37 CFR 1.84(n).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“at least one ventilation device which is suitable and configured for producing at least one respiratory gas flow for ventilating a patient and setting the respiratory gas flow to at least one ventilation pressure depending on at least one respiratory phase of the patient” in claims 41 and 56.
“at one monitoring device which is suitable and configured for monitoring a synchronicity between respiratory phase and ventilation pressure by capturing at least one characteristic signal for the ventilation pressure and at least one characteristic signal for the respiratory phase of the patient and comparing the at least one characteristic signal for the ventilation pressure and the at least one characteristic signal for the respiratory phase to one another and determining at least one characteristic for the synchronicity based on the comparison, the monitoring device being further suitable and configured for identifying at least one type of lack of synchronicity and using said at least one type of lack of synchronicity for determining the characteristic of the synchronicity” in claims 41 and 56.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 41-46, 51-52, 55-56, 58, and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al (10,137,266) in view of Sinderby (10,376,663), Jafari et al (2009/0241955), Thiessen (2011/0029910), and Milne et al (2015/0090258).
Regarding claim 41, Shelly discloses a ventilator (50) (pressure support system), wherein the ventilator (50) comprises at least one ventilation device (52) (gas flow generator) which is suitable and configured for producing at least one respiratory gas flow for ventilating a patient and setting the respiratory gas flow to at least one ventilation pressure depending on at least one respiratory phase of the patient (col 6, ln 26-33), and further comprises at least one monitoring device (64) (controller (64) includes software for monitoring sensor data to determine if dyssynchrony occurs) (col 8, ln 3-16) which is suitable and configured for monitoring a synchronicity between respiratory phase and ventilation pressure by capturing at least one characteristic signal for the ventilation pressure and at least one characteristic signal for the respiratory phase of the patient (monitoring device (64) checks for synchrony by obtaining a flow signal from the user and adjusting the ventilation device (52) when dyssynchrony between the ventilator (50) and the patient is determined, the monitoring device captures a characteristic signal for ventilation pressure and shows said sigh as a patient flow waveform (col 6, ln 45-61), and a characteristic signal for the respiratory phase is captured and shown as an inspiratory and expiratory phase waveform (col 7, ln 20-36), and determining dyssynchrony between the ventilator and patient by checking to see if the characteristic signal for ventilation pressure and the characteristic signal for respiratory phase meet certain criterion to determine a characteristic for synchronicity, (col 8 ln 3-16).
Shelly does not disclose comparing the characteristic signal for the ventilation pressure and the characteristic signal for the respiratory phase to one another and determining at least one characteristic for the synchronicity based on the comparison, the at least one type of lack of synchronicity being taken from (i) target ventilation pressures specified prematurely in relation to the respiratory phase of the patient; (ii) target ventilation pressures specified belatedly in relation to the respiratory phase of the patient; (iii) target ventilation pressures missed in relation to the respiratory phase of the patient, the target ventilation pressures missed in relation to the respiratory phase of the patient comprising at least one missed target expiration pressure and/or the target ventilation pressures specified prematurely in relation to the respiratory phase of the patient comprising a premature target inspiration pressure and/or a premature target expiration pressure and/or the target ventilation pressures specified belatedly in relation to the respiratory phase of the patient comprising a belated target inspiration pressure and/or a belated target expiration pressure.
However, Sinderby in figs 1-7 teaches a ventilator including a monitoring device comprising a computer (19) and sensors (30) (col 10, ln 58-col 11, ln 10), wherein the monitoring device is configured to characteristic signal for ventilation pressure and the characteristic signal for respiratory phase to one another to determine at least one characteristic for the synchronicity based on the comparison (sensors are used to obtain the characteristic signals, which are plotted as a waveform, and compares the signals to determine if there is synchronicity between the signals or if the compared signals represent early or late triggering of the ventilator assist) (col 2, ln 14-24, col 7 ln 3-33),
the at least one type of lack of synchronicity being taken from (i) target ventilation pressures specified prematurely in relation to the respiratory phase of the patient
(the peak of a target ventilation pressure Pvent, which is a target ventilator assist pressure, is shown to be specified prematurely in relation to the respiratory phase of the patient) (fig 4, col 5 ln 52-67, col 6 ln 9-17); (ii) target ventilation pressures specified belatedly in relation to the respiratory phase of the patient (the peak of the target ventilation pressure Pvent is shown to be specified belatedly in relation to the respiratory phase of the patient) (fig 5, col 6, ln 18-25); (iii) target ventilation pressures missed in relation to the respiratory phase of the patient (the peak of the target ventilation pressure Pvent is shown to have missed in relation to the respiratory phase of the patient) (fig 7, col 6 ln 34-45), the target ventilation pressures missed in relation to the respiratory phase of the patient comprising at least one missed target expiration pressure (a sensed target expiration pressure of the target ventilation pressure Pvent is shown to have missed as the target expiration pressure occurs before the exhalation phase of the respiratory phase, shown as between On1 and Off1) (fig. 3 col 5 ln 7-23, col 3, ln 52-col 6, ln 8).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the monitoring device of Shelly to be configured to compare the characteristic signal for the ventilation pressure and the characteristic signal for the respiratory phase to one another and determining at least one characteristic for the synchronicity based on the comparison, the at least one type of lack of synchronicity being taken from (i) target ventilation pressures specified prematurely in relation to the respiratory phase of the patient; (ii) target ventilation pressures specified belatedly in relation to the respiratory phase of the patient; (iii) target ventilation pressures missed in relation to the respiratory phase of the patient, the target ventilation pressures missed in relation to the respiratory phase of the patient comprising at least one missed target expiration pressure and/or the target ventilation pressures specified prematurely in relation to the respiratory phase of the patient comprising a premature target inspiration pressure and/or a premature target expiration pressure and/or the target ventilation pressures specified belatedly in relation to the respiratory phase of the patient comprising a belated target inspiration pressure and/or a belated target expiration pressure as taught by Sinderby in order to increase to accuracy of the monitoring device to detect dyssynchrony to allow the user to better account for the needs of the patient (Sinderby, col 8, ln 58-61).
The now-modified Shelly’s device does not disclose the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold for a period of time and/or a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow for a period of time
However Jafari teaches a ventilator, wherein the ventilator includes monitoring device including sensors and a controller (50) (para [0022]) and wherein the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold (flow triggering threshold can be set by the operate in the form of a fixed flow rate for triggering sensitivity) (para [0049]) for a period of time (flow threshold may be characterized as a flow rate over a period of time, such as an average flow rate or a total flow volume for a designated period) (para [0050]), and/or a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow (peak inspiratory flow cycling threshold may be set as a fixed percentage of peak flow for cycling sensitivity (para [0049]) for a period of time (para [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Shelly so that the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold for a period of time and/or a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow for a period of time as taught by Jafari in order to allow lung flow information to be used to identify patient-initiated phase transitions (Jafari, para [0049]).
The now-modified Shelly’s device does not disclose the at least one threshold defining a respiratory air flow of less than or equal to 4 l/min for a period of time of more than half a second and less than six seconds.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the at least one threshold defining a respiratory air flow of less than or equal to 4 l/min for a period of time of more than half a second and less than six seconds, as the flow trigger threshold and/or peak inspiratory flow cycling threshold may be set by the operator (Jafari, para [0049]), and it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, modifying the threshold values of respiratory air flow and the period of time by routine experimentation would have been an obvious modification in order to provide suitable valves to identify patient-initiated phase transitions (Jafari, para [0049]).
In the alternative, although the modified Shelly references do not explicitly disclose the at least one threshold defining a respiratory air flow of less than or equal to 4 l/min for a period of time of more than half a second and less than six seconds, Thiessen in figs 2 and 5 teaches that a ventilator (202) includes a monitoring device (224) that monitors a threshold for respiratory air flow to determine if the respiratory air flow is less than 4 I/min for a period of time (the monitoring device (224) monitors the respiratory airflow to determine if the respiratory air flow is 2.5 l/min for a period of time to determine if a recruitment maneuver is necessary (paras [0012] and para [0057]); and Milne discloses that a ventilator (202) includes a monitoring device (224) which determines if a threshold for a respiratory air flow’s period of time is 5 seconds (the monitoring device (224) determines if a respiration air flow breaches a predetermined threshold for a period of 5 seconds to determine if a ventilator 202 error occurred (paras [0141]-[0144]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shelly monitoring device to determine if the respiratory air flow has fallen below the threshold for a period of 5 seconds, as taught by Thiessen and Milne in order to be able to allow the monitoring device to be provided with known flow thresholds to be able to detect and respond to respiratory air flow events (Thiessen, para [0012]), and to allow the monitoring device to be provided with a known time threshold that would allow the monitoring device to be able to further prevent patient discomfort (Milne, para. [0139]).
Regarding claim 42, the modified Shelly reference discloses that the target ventilation pressures missed in relation to the respiratory phase of the patient comprise the missed target expiration pressure (a sensed target expiration pressure of the target ventilation pressure Pvent is shown to have missed as the target expiration pressure occurs before, but not during, the exhalation phase of the respiratory phase, shown as between On1 and Off1) (Sinderby, fig 3, col 5, ln 7-23, col 5, ln 52-col 6, line 8).
Regarding claim 43, the modified Shelly’s reference discloses that the target ventilation pressures specified prematurely in relation to the respiratory phase of the patient comprise a premature target inspiration pressure and/or a premature set expiration pressure (a sensed target inspiration pressure of the target ventilation pressure Pvent is shown to be premature as the target inspiration pressure occurs before the inspiratory phase of the respiratory phase, shown as between On1 and Off1) (Sinderby, fig 4, col 5, ln 7-23, col 5, ln 52-col 6, line 8).
Regarding claim 44, the modified Shelly’s reference discloses that the target ventilation pressures specified belatedly in relation to the respiratory phase of the patient comprise a belated target inspiration pressure (a sensed target inspiratory pressure of the target ventilation pressure Pvent is shown to be belated as the target expiration pressure occurs after the inspiratory phase of the respiratory phase has occurred, shown as between On1 and Off1) (Sinderby, fig 5, col 5, ln 7-23, col 5, ln 52-col 6, line 8).
Regarding claim 45, the modified Shelly’s reference discloses the monitoring device is suitable and configured for identifying a missed target inspiration pressure by virtue of the characteristic signal for the respiratory phase at a defined time representing an exhalation phase and by virtue of the characteristic signal for the ventilation pressure indicating that the last ventilation pressure set before the defined time is a target expiration pressure and not a target inspiration pressure (the missed target inspiration pressure is identified by detecting that the characteristic signal for the respiratory phase at a defined time represents an exhalation phase, which is shown as after Off1 and point C but before On2, and detecting that the characteristic signal for the ventilation pressure indicating that the last target ventilation pressure set before the defined time is a target expiration pressure. The target expiration pressure is represented as the portion of the waveform after point C but before point T, which is when the target ventilation pressure Pvent is providing the target expiration pressure not the inspiration pressure) (Sinderby, figs 7 and 9, col 5, ln 33-67, col 6 ln 9-17, col 7 ln 39-59).
Regarding claim 46, modified Shelly discloses the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold, the at least one threshold defining a drop in the respiratory air flow of in relation to a maximum value of the respiratory air flow (a peak inspiratory flow cycling threshold in the form a fixed percentage of peak flow for cycling sensitivity) (Jafari, para [0049]) for a period of time (flow threshold may be characterized as a flow rate over a period of time, such as an average flow rate or a total flow volume for a designated period) (Jafari, para [0050]).
Modified Shelly does not disclose the threshold defining a drop in the respiratory air flow of at least 5 l/min in relation to a maximum value of the respiratory air flow for a period of time of more than half a second and less than six seconds.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the at least one threshold defining a drop in the respiratory air flow of at least 5 l/min in relation to a maximum value of the respiratory air flow for a period of time of more than half a second and less than six seconds, as the flow trigger threshold and/or peak inspiratory flow cycling threshold may be set by the operator (Jafari, para [0049]), and it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, modifying the threshold values of a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow and the period of time by routine experimentation would have been an obvious modification in order to provide suitable valves to identify patient-initiated phase transitions (Jafari, para [0049]).
Regarding claim 51, the modified Shelly’s discloses the monitoring device is suitable and configured for identifying a missed premature target ventilation pressure by virtue of a ventilation parameter derived from the characteristic signal for the ventilation pressure reaching a threshold (the step of identifying a missed premature target ventilation pressure Pvent, shown to be premature by being a target ventilation pressure occurring before an inspiratory phase, is made by checking if there is a delay, which is a trigger and cycling off error represented by point T and point C, in the characteristic signal for the ventilation pressure and if the delay has reached an error threshold in a negative quadrant) (Sinderby, figs 4 and 9, col 5, ln 33-67, col 6, ln 9-25, col 7, ln 39- 52 and ln 58-67 and col 8, ln 1-61).
Regarding claim 52, the modified Shelly’s discloses the monitoring device is suitable and configured for identifying an occurrence of a lack of synchronicity by virtue of a similarity measure between the characteristic signal for the respiratory phase and the characteristic signal for the ventilation pressure reaching a threshold (the step of identifying a lack of synchronicity is made by checking if there is a similarity measure in the form of a delay, which is a trigger and cycling off error represented by point T and point C. A delay of zero percent being representative of the characteristic signal for ventilation pressure and characteristic signal for the respiratory phase being synchronized and a delay reaching an error threshold in a positive or negative quadrant indicating a lack of synchronicity) (figs 9-10, col 5, ln 33-51, col 6, ln 18-25, col 7, ln 39-52 and ln 58-67, col 8, ln 1-61).
Regarding claim 55, the modified Shelly’s reference discloses that the monitoring device is suitable and configured for counting a frequency of an occurrence of the types of lack of synchronicity (i) to (iii) during a defined time interval and taking the frequency of the occurrence into account in the characteristic (the type, frequency, and occurrence of the characteristic of the lack of synchronicity, represented as a delay in the form of trigger and cycling-off errors, during the defined time interval between on1 and off3 are used to correct the ventilation device) (Sinderby, figs 9 and 13, col 8, ln 6-61 and col 9, ln 45-63).
Regarding claim 56, Shelly discloses a ventilator (50) (pressure support system), wherein the ventilator (50) comprises at least one ventilation device (52) (gas flow generator) which is suitable and configured for producing at least one respiratory gas flow for ventilating a patient and setting the respiratory gas flow to at least one ventilation pressure depending on at least one respiratory phase of the patient (col 6, ln 26-33), and further comprises at least one monitoring device (controller (64) includes software for monitoring sensor data to determine if desynchrony occurs) (col 8, ln 3-16)
which is suitable and configured for monitoring a synchronicity between respiratory phase and ventilation pressure by capturing at least one characteristic signal for the ventilation pressure and at least one characteristic signal for the respiratory phase of the patient (monitoring device checks for synchrony by obtaining a flow signal from the user and adjusting the ventilation device (52) when desynchrony between the ventilator (50) and the patient is determined, the monitoring device captures a characteristic signal for ventilation pressure and shows said sigh as a patient flow waveform (col 6, ln 45-61), and a characteristic signal for the respiratory phase is captured and shown as an inspiratory and expiratory phase waveform (col 7, ln 20-36), the monitoring device further influencing a function of a control device comprised in the ventilator by way of information feedback about an occurrence of a lack of synchronicity, or type, frequency and strength thereof (the monitoring device controls a control device, software of the controller (64) which controls the flow generator (52) and valve (60), to decrease a backup frequency provided by the ventilator 50 and decrease an expiratory positive airway pressure in response to detecting a lack of synchronicity (col 7 ln 28-36 and col 12 ln 42-53).
Shelly does not disclose comparing the characteristic signal for the ventilation pressure and the characteristic signal for the respiratory phase to one another and determining at least one characteristic for the synchronicity based on the comparison.
However, Sinderby in figs 1-7 teaches a ventilator including a monitoring device comprising a computer (19) and sensors (30) (col 10, ln 58-col 11, ln 10), wherein the monitoring device is configured to characteristic signal for ventilation pressure and the characteristic signal for respiratory phase to one another to determine at least one characteristic for the synchronicity based on the comparison (sensors are used to obtain the characteristic signals, which are plotted as a waveform, and compares the signals to determine if there is synchronicity between the signals or if the compared signals represent early or late triggering of the ventilator assist) (col 2, ln 14-24, col 7 ln 3-33).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the monitoring device of Shelly to be configured to compare the characteristic signal for the ventilation pressure and the characteristic signal for the respiratory phase to one another and determining at least one characteristic for the synchronicity based on the comparison as taught by Sinderby in order to increase to accuracy of the monitoring device to detect desynchrony to allow the user to better account for the needs of the patient (Sinderby, col 8, ln 58-61).
The now-modified Shelly’s device does not disclose the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold for a period of time and/or a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow for a period of time
However Jafari teaches a ventilator, wherein the ventilator includes monitoring device including sensors and a controller (50) (para [0022]) and wherein the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold (flow triggering threshold can be set by the operate in the form of a fixed flow rate for triggering sensitivity) (para [0049]) for a period of time (flow threshold may be characterized as a flow rate over a period of time, such as an average flow rate or a total flow volume for a designated period) (para [0050]), and/or a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow (peak inspiratory flow cycling threshold may be set as a fixed percentage of peak flow for cycling sensitivity (para [0049]) for a period of time (para [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Shelly so that the monitoring device is suitable and configured for identifying a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold for a period of time and/or a drop in the respiratory air flow in relation to a maximum value of the respiratory air flow for a period of time as taught by Jafari in order to allow lung flow information to be used to identify patient-initiated phase transitions (Jafari, para [0049]).
The now-modified Shelly’s device does not disclose the at least one threshold defining a respiratory air flow of less than or equal to 4 l/min for a period of time of more than half a second and less than six seconds.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the at least one threshold defining a respiratory air flow of less than or equal to 4 l/min for a period of time of more than half a second and less than six seconds, as the flow trigger threshold and/or peak inspiratory flow cycling threshold may be set by the operator (Jafari, para [0049]), and it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, modifying the threshold values of respiratory air flow and the period of time by routine experimentation would have been an obvious modification in order to provide suitable valves to identify patient-initiated phase transitions (Jafari, para [0049]).
In the alternative, although the modified Shelly references do not explicitly disclose the at least one threshold defining a respiratory air flow of less than or equal to 4 l/min for a period of time of more than half a second and less than six seconds,
Thiessen in figs 2 and 5 teaches that a ventilator (202) includes a monitoring device (224) that monitors a threshold for respiratory air flow to determine if the respiratory air flow is less than 4 I/min for a period of time (the monitoring device (224) monitors the respiratory airflow to determine if the respiratory air flow is 2.5 l/min for a period of time to determine if a recruitment maneuver is necessary (paras [0012] and para [0057]); and Milne discloses that a ventilator (202) includes a monitoring device (224) which determines if a threshold for a respiratory air flow’s period of time is 5 seconds (the monitoring device (224) determines if a respiration air flow breaches a predetermined threshold for a period of 5 seconds to determine if a ventilator 202 error occurred (paras [0141]-[0144]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shelly monitoring device to determine if the respiratory air flow has fallen below the threshold for a period of 5 seconds, as taught by Thiessen and Milne in order to be able to allow the monitoring device to be provided with known flow thresholds to be able to detect and respond to respiratory air flow events (Thiessen, para [0012]), and to allow the monitoring device to be provided with a known time threshold that would allow the monitoring device to be able to further prevent patient discomfort (Milne, para. [0139]).
Regarding claim 58, the modified Shelly’s device discloses that the information feedback influences the control device to change a backup frequency (the information feedback from the monitoring device controls the control device to decrease a backup frequency provided by the ventilator in response to detecting a lack of synchronicity) (Shelly, col 7, ln 28-36, col 12, ln 42-53).
Regarding claim 60, the modified Shelly’s device discloses that the information feedback influences the control device to change an inspiratory positive airway pressure (the information feedback from the monitoring device controls the control device to change a backup breath rate, which increases inspiratory positive airway pressure by having the ventilator (50 of Shelly) provide a machine breath to the user, in response to detecting a lack of synchronicity) (Shelly, col 5, ln 4-14, col 7, ln 20-32, col 12, ln 42-53).
Claims 47-50, 57 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al, Sinderby, Jafari et al, Thiessen, and Milne et al as applied to claims 41 and 56 above, and further in view of Angelico et al (9,027,552).
Regarding claim 47, modified Shelly discloses that the monitoring device is suitable and configured for identifying a belated target ventilation pressure by virtue of a characteristic functional feature in a time curve of the characteristic signal for the ventilation pressure occurring with a delay in relation to a corresponding characteristic functional feature in a time curve of the characteristic signal for the respiratory phase and by virtue of the delay reaching a threshold (the identification of a belated target ventilation pressure Pvent is determined when the ventilation pressure Pvent occurs after the patient's inspiratory effort, shown as the increase of Pvent waveform when the peak inspiratory effort waveform is closest to its decline at Off1 (see fig 5 of Sinderby); a characteristic function feature in a time curve, being the start of the target ventilation pressure at T on the time curve, occurring with a delay in relation to a corresponding characteristic functional feature in a time curve of the characteristic signal for the respiratory phase, being represented as the On1 characteristic functional feature in a time curve for the respiratory phase of the patient, the delay being shown to reach a threshold where the delay is a period of time past the patient's inspiratory effort such that a trigger and cycling off error is recorded) (Sinderby, fig 5, col 5, ln 33-51, col 6, ln 9-17, col 7, ln 39-52, col 7, ln 58-col 8, line 61).
Modified Shelly does not disclose the virtue of the delay reaching a threshold being at least 100 ms.
However, Angelico in figures 2A-4 teaches that a monitoring device (224) determines a threshold for a delay of a belated ventilation pressure is at least 100 ms (a late trigger for a ventilation pressure is recorded when a ventilation pressure is delayed, past a patient's inspiratory effort, for at least 100 ms, the threshold being adjustable to at least 150 ms based on the patient) (col 27, ln 37-col 28, ln 15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of modified Shelly so that the threshold for the delay to be at least 100 ms as taught by Angelico, to be able to allow the monitoring device to accommodate different patients to prevent patient discomfort (Angelico, col 27, ln 40-47).
Regarding claim 48, the modified Shelly device discloses that the threshold for the delay is at least 150 ms (the threshold for the delay can be adjusted to within 10 ms to 200 ms, or 150 ms, based on the patient) (Angelico, col 27, ln 37-col 28, ln 15).
Regarding claim 49, modified Shelly discloses that the monitoring device is suitable and configured for identifying a premature target ventilation pressure by virtue of a characteristic functional feature in a time curve of the characteristic signal for the ventilation pressure occurring with a delay in relation to a corresponding characteristic functional feature in a time curve of the characteristic signal for the respiratory phase and by virtue of the delay dropping below a threshold (the identification of a premature target ventilation pressure Pvent is determined when the set ventilation pressure Pvent starts before the beginning of the patients inspiratory effort, shown as the increase of Pvent waveform before the peak inspiratory effort waveform starts to increase at On1, see fig. 4; a characteristic function feature in a time curve, being the start of the target ventilation pressure at T on the time curve, occurring with a delay in relation to a corresponding characteristic functional feature in a time curve of the characteristic signal for the respiratory phase, being represented as the On1 characteristic functional feature in a time curve for the respiratory phase of the patient, the delay being shown to reach a threshold where the delay is a period of time before the patient's inspiratory effort such that a trigger and cycling off error is recorded) (Sinderby, fig 4, col 5, ln 33-51, col 6, ln 18-25, col 7, ln 39-67, col 8, ln 1-61).
Modified Shelly does not disclose the threshold being not more than 10 ms.
However, Angelico in figures 2A-4 teaches that a monitoring device (224) determines a threshold for a delay of an premature ventilation pressure is at least 10 ms (an early trigger for a ventilation pressure is recorded when a ventilation pressure is delayed, occurring before a patient's inspiratory effort, within 10 ms based on the patient) (col 26, line 42-col 27, line 18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shelly threshold for the delay to be not more than 10 ms as taught by Angelico, to be able to allow the monitoring device to accommodate different patients to prevent patient discomfort, patient fatigue, hypercapnia, and/or hypoxemia (Angelico, col 26, ln 43-53)
Regarding claim 50, the modified Shelly’s reference discloses that the threshold is less than 10 ms (Angelico, col 27, ln 64-66), and therefore, because the disclosed range overlaps with the claimed threshold range of less than 5 ms, a prima facie case of obviousness exists.
Regarding claims 57 and 59, modified Shelly discloses everything as claimed including the information feedback influencing a function of the control device based on an occurrence of a lack of synchronicity (Shelly, col 7, ln 28-36, col 12, ln 42-53).
Shelly does not disclose the information feedback influences the control device to change trigger sensitivities for spontaneous inspirations and expirations or that the information feedback influences the control device to change an inspiration duration for mandatory inspirations and expirations.
However, Angelico in figures 1-4 discloses that a ventilator (202) includes a monitoring device (224) influencing a function of a control device (226) comprised in the ventilator (202) by way of information feedback to influence the control device (224) to change trigger sensitivities for spontaneous inspirations and expirations and to change an inspiration duration for mandatory inspirations and expirations (when the monitoring device (224) detects a lack of synchronicity, the monitoring device (202) will influence a function of the control device (226) to change trigger sensitivities for spontaneous inspirations and expirations (col 12, ln 2-14, col 36 ln 7-19 and 64-67), and to change an inspiration duration for mandatory inspirations and expirations (col 14, ln 50-65, col 15, ln 5-28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shelly monitoring device to influence the control device to change trigger sensitivities for spontaneous inspirations and expirations and to influence the control device to change an inspiration duration for mandatory inspirations and expirations, as taught by Angelico in order to be able to allow the monitoring device to influence the control device to provide a higher likelihood of mitigating the detected lack of synchronicity (Angelico, col 36, ln 33-35).
Claims 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al, Sinderby et al, Jafari et al, Thiessen, and Milne et al as applied to claims 41 and 56 above, and further in view of Masic et al (2012/0167885).
Regarding claim 53, modified Shelly discloses that the monitoring device is suitable and configured for ascertaining a missed target ventilation pressure by searching for at least one characteristic curve in a characteristic signal for the respiratory phase or in the characteristic signal for the ventilation pressure which does not occur in the other characteristic signal (the set ventilation pressure Pvent is shown to have missed as the rise in the waveform for the characteristic signal for the ventilation pressure occurs during the exhalation phase of the characteristic signal for the respiratory phase, shown as between Off1 and On2) (Sinderby, figs 7 and 9, col 5, ln 33-67, col 6, ln 34-45, and col 7, line 39 and ln 58-59)
Modified Shelly does not disclose the monitoring device ascertaining a missed target ventilation pressure by virtue of at least one pattern recognition.
However, Masic teaches in figures 1-4 that a monitoring device 20 for a ventilator (10) performs pattern recognition for obtaining and determining a characteristic signal for a ventilator (10) (a ventilation system (1) uses the monitoring device (20) to determine and calculates several predicted characteristic signals for a respiratory phase to more accurately account for patient effort during operation) (para [0030] ln 17-30, para [0031], para [0036] and paras [0055]-[0057]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shelly monitoring device to perform pattern recognition to ascertain the missed target ventilation pressure, as taught by Masic, so as to be able to allow the monitoring device to more accurately control the ventilator by providing a gas delivery metric that that is based on a computed patient effort value to cause gas to be delivered consistent with the gas delivery metric (Masic, para [0004]).
Regarding claim 54, modified Shelly discloses everything as claimed including the monitoring device being suitable and configured for ascertaining a premature target ventilation pressure by searching for at least one time duration in time curves in the characteristic signal for the respiratory phase and in the characteristic signal for the ventilation pressure which leads to the greatest similarity of these characteristic signals in the case of a temporal displacement of at least one of the characteristic signals (a premature target ventilation pressure Pvent is determined when the set ventilation pressure Pvent starts before the beginning of the patients inspiratory effort, shown as the increase of Pvent waveform before the peak inspiratory effort waveform starts to increase at On, where the set ventilation pressure Pvent waveform and the characteristic signal for the respiratory phase have the greatest similarity of characteristic signals during the temporal displacement of the characteristic signal for the ventilation pressure (Sinderby, figs 4 and 9, col 5, ln 33-51, col 6, ln 18-25, col 7, ln 39-52 and 58-67, col 8 ln 1-61),
Modified Shelly does not disclose the monitoring device ascertaining a premature target ventilation pressure by way of pattern recognition.
However, Masic in figures 1-4 teaches that a monitoring device (20) for a ventilator (10) performs pattern recognition for obtaining and determining a characteristic signal for a ventilator (10) (a ventilation system (1) uses the monitoring device (20) to determine and calculates several predicted characteristic signals for a respiratory phase to more accurately account for patient effort during operation (paras [0030], ln 17-30, para [0031], para [0036] and paras. [0055]-[0057]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Shelly monitoring device to perform pattern recognition to ascertain the premature target ventilation pressure, as taught by Masic, so as to be able to allow the monitoring device to more accurately control the ventilator by providing a gas delivery metric that that is based on a computed patient effort value to cause gas to be delivered consistent with the gas delivery metric (Masic, para [0004]).
Response to Arguments
Applicant's arguments filed 8/1/2025 have been fully considered but they are not persuasive.
Applicant argues on page 9, fifth full paragraph-page 11, first full paragraph of applicant’s remarks that Thiessen and Milne do not relate to a characteristic signal representing an exhalation phase, and therefore, it would not have been obvious to apply the teaching of Thiessen and Milne to teach flow threshold values for an exhalation phase. However, Jafari teaches a ventilator configured to identify a characteristic signal representing the exhalation phase by virtue of a respiratory air flow of the patient dropping below at least one threshold (flow triggering threshold can be set by the operate in the form of a fixed flow rate for triggering sensitivity) (para [0049]) for a period of time (flow threshold may be characterized as a flow rate over a period of time, such as an average flow rate or a total flow volume for a designated period) (para [0050]), and/or a drop in the respiratory air flow in rela