DETAILED ACTION
This Office Action is in response to the amendment, filed on June 8, 2026. Primary Examiner acknowledges Claims 128-147 are pending in this application, with Claims 128 and 138 having been currently amended, and Claims 1-127 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 128 is objected to because of the following informalities:
In Line 8, the word “sur” is found; which appears to be a typographical error of the word “user”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 128-147 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
(STEP 1): Four Categories of Statutory Subject Matter
This application contains two (2) independent claims, Claims 128 and 138, wherein independent claim, Claim 128, and its dependent claims, Claims 129-137, recite a method that is one of the four statutory categories, and wherein independent claim, Claim 138, and its dependents claims, Claims 139-147, recite an apparatus that is one of the four statutory categories.
In particular, the subject matter of the independent method claim, Claim 128, and further as incorporated into its dependent claims, Claims 129-137, explicitly recite:
A method for determining a user interface issue with a respiratory therapy system, the method comprising:
generating, via a flow rate sensor positioned within the respiratory therapy system, a plurality of flow rate values, wherein the plurality of flow rate values are associated with pressurized air directed to an airway of a user of the respiratory therapy device; generating, via a pressure sensor positioned within the respiratory therapy system, a plurality of pressure values, wherein the plurality of pressure values are associated with the pressurized air directed to the airway of the sur [sic: user], each of the plurality of pressure values corresponding to a respective one of the plurality of flow rate values;
determining, based on the plurality of flow rate values and the plurality of pressure values, an intentional leak characteristic curve for the respiratory therapy system, wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure;
determining, based on the intentional leak characteristic curve, an occurrence of an unintentional leak; and
determining, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists.
In particular, the subject matter of the independent apparatus claim, Claim 138, and further as incorporated into its dependent claims, Claims 139-147, explicitly recite:
A system for determining a user interface issue with a respiratory therapy system, the system comprising:
a flow rate sensor, wherein the flow rate sensor is configured to detect flow rate values associated with the respiratory therapy system;
a pressure sensor, wherein the pressure sensor is configured to generate pressure values associated with the respiratory therapy system;
a control system, wherein the control system is configured to:
determine, based on a plurality of flow rate values and a plurality of pressure values, an intentional leak characteristic curve for the respiratory therapy system;
determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure; and
determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists.
The commonality of independent claims, Claims 128 and 138, both reciting the operations of:
determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure;
determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak; and
determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists.
Consequently, the foregoing analysis is based on the commonality of limitations.
(STEP 2): Whether a Claim is Directed to a Judicial Exception
(STEP 2A, PRONG ONE): Whether a Claim Recites an Abstract Idea, Law of Nature, or Natural Phenomenon
Regarding “determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system, wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure”, this limitation appears to be directed towards a mental process that can be performed by a person simply observing the output of “a flow rate sensor” and “a pressure sensor”. Thus, this limitation is an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG. Additionally it is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Regarding “determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak”, this limitation appears to be directed to mathematical concepts performed by a person. Thus, this limitation is a mathematical formula or equation, which is grouped as mathematical concepts under 2019 PEG. Additionally it is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Regarding “determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists” this limitation is a mathematical relationship, which is grouped as a mathematical concept under 2019 PEG. Additionally it is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Therefore, the subject matter of the independent claims, Claims 128 and 138 and further as incorporated into their dependent claims, Claims 129-137 and 139-147, are directed to a judicial exception because they recite an abstract idea.
(STEP 2A, PRONG TWO): Whether a Claim Recites Additional Elements that Integrate the Judicial Exception into a Practical Application
With respect to the independent method claim, Claim 128, and further as incorporated into its dependent claims, Claims 129-137, although the subject matter of Claim 128 is directed to a judicial exception – abstract idea, this judicial exception is not integrated into a practical application as the additional element of “a respiratory therapy system” (Claim 128, Line 1) is simply an element that is known to convey air or breathable gas to a patient and amounts to being conventional practice in the field of the use.
With respect to the independent apparatus claim, Claim 138, and further as incorporated into its dependent claims, Claims 139-147, although the subject matter of Claim 138 is directed to a judicial exception – abstract idea, this judicial exception is not integrated into a practical application as the additional elements of “a respiratory therapy system” (Claim 138, Line 1) is simply an element that is known to convey air or breathable gas to a patient, the “flow rate sensor” (Claim 138, Line 3) is a simple element known to detect flow rate values, the “pressure sensor” (Claim 138, Line 5) is a simple element known to detect pressure values, and the “control system” (Claim 138, Line 7) is a simple element known to receive signals from the “flow rate sensor” and/or “pressure sensor” to modulate the conveyance of air or breathable gas patient at the desired levels. Thus, these additional elements amount to being conventional practice in the field of the use.
Consequently, addressing the commonality of independent claims, Claims 128 and 138, it is noted Applicant’s invention does not include any discussion of how the claimed invention provides a technical improvement realized by the claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex., LLC v. DirecTV, LLC, No. 15-1845 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
Therefore, for these reasons, the aforementioned abstract idea of the independent claims, Claims 128 and 138 and further as incorporated into their dependent claims, Claims 129-137 and 139-147, are not integrated into a practical application under 2019 PEG.
(STEP 2B): Whether a Claim Amounts to Significantly More
Regarding “determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system, wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure”, Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses a method and system for determining a user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) with a respiratory therapy system (Figure 1), comprising: a flow rate sensor (4f, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053), wherein the flow rate sensor (4f) is configured to detect flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) associated with the respiratory therapy system (Figure 1); a pressure sensor (4p, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053), wherein the pressure sensor (4p) is configured to detect pressure values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) associated with the respiratory therapy device (Figure 1); a control system (15, “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t). The controller or processor is configured and adapted to perform the methodology described in more detail herein. The controller or processor may include integrated chips, a memory and/or other instruction or data storage medium to implement the control methodology.” Para 0056; also see: “The controller or processor 15 is further adapted to derive parameters indicative of the patient's breathing and sleep pattern, such as for deriving indications of flow limitation, such as flow flattening, snore, apnea and hypopnea and the Apnea Hypopnea Index (AHI), and for distinguishing between REM and non-REM sleep.” Para 0057; “If more than a predetermined number of successive--or cumulative--negative feedback responses are recorded, the controller will cause display of a message advising the patient to contact the clinician.” Para 0067; “Details of the patient feedback responses, and the treatment pressures may be stored in the controller for later review by the clinician.” Para 0068; “In an embodiment, the controller may be programmable by the clinician using the menu system to alter the parameters of the `first timer` mode, for example, to set the initial therapy session pressure and/or the daily pressure increment according to the severity of the patient's sleep disordered breathing and the clinician's opinion of how long the patient may take to acclimatize to the sensations of the CPAP therapy.” Para 0069), wherein the control system (15) is configured to: determine, based on a plurality of flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) and a plurality of pressure values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) corresponding to the plurality of flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) a leak characteristic curve (Figures 4 and 5, wherein “FIG. 4 is a graph of a mask pressure against blower set pressure, showing mask leak” Para 0048 and wherein “FIG. 5 is a flowchart illustrating mask leak control according to an embodiment of the invention” Para 0049; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “In a further embodiment of the invention, described with reference to FIGS. 4 and 5, the response of the blower to changes indicative of excessive air leakage at the patient interface is controlled for improved patient comfort and compliance and reduced possibility of disturbance.” Para 0143; “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) for the respiratory therapy system (Figure 1) was known.
Consequently, as the additional elements of “a respiratory therapy system” (Claim 138, Line 1) is simply an element that is known to convey air or breathable gas to a patient, the “flow rate sensor” (Claim 138, Line 3) is a simple element known to detect flow rate values, the “pressure sensor” (Claim 138, Line 5) is a simple element known to detect pressure values, and the “control system” (Claim 138, Line 7) is a simple element known to receive signals from the “flow rate sensor” and/or “pressure sensor” to modulate the conveyance of air or breathable gas patient at the desired levels. Thus, the usage of these additional elements to arrive upon the aforementioned operational limitations of the claims are well-known routine, and conventional practice in the art and field of endeavor in order to achieve the step to “determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system, wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure”.
Regarding “determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak”, Armitstead et al. (2011/0203588, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the distinction between “an intentional leak” and “an unintentional leak” as claimed, whereby “determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system; determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak; and determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists”, Armitstead teaches the explicit methodology utilized to identify a distinction between “an intentional leak” and “an unintentional leak” as claimed. Explicitly, Armitstead teaches “5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154) was known.
Consequently, as the additional elements of “a respiratory therapy system” (Claim 138, Line 1) is simply an element that is known to convey air or breathable gas to a patient, the “flow rate sensor” (Claim 138, Line 3) is a simple element known to detect flow rate values, the “pressure sensor” (Claim 138, Line 5) is a simple element known to detect pressure values, and the “control system” (Claim 138, Line 7) is a simple element known to receive signals from the “flow rate sensor” and/or “pressure sensor” to modulate the conveyance of air or breathable gas patient at the desired levels. Thus, the usage of these additional elements to arrive upon the aforementioned operational limitations of the claims are well-known routine, and conventional practice in the art and field of endeavor in order to achieve the step to “determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak”.
Regarding “determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists” Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the determine based on the occurrence of a leak, that the user interface (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) with the respiratory therapy system (Figure 1) exists, whereby the data ascertained by the controller can be utilized to notify the user “adjust the fit of the mask” (“The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) was known.
Consequently, as the additional elements of “a respiratory therapy system” (Claim 138, Line 1) is simply an element that is known to convey air or breathable gas to a patient, the “flow rate sensor” (Claim 138, Line 3) is a simple element known to detect flow rate values, the “pressure sensor” (Claim 138, Line 5) is a simple element known to detect pressure values, and the “control system” (Claim 138, Line 7) is a simple element known to receive signals from the “flow rate sensor” and/or “pressure sensor” to modulate the conveyance of air or breathable gas patient at the desired levels. Thus, the usage of these additional elements to arrive upon the aforementioned operational limitations of the claims are well-known routine, and conventional practice in the art and field of endeavor in order to achieve the step to Regarding “determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists”.
Therefore, the aforementioned abstract idea of the independent claims, Claims 128 and 138 and further as incorporated into their dependent claims, Claims 129-137 and 139-147, are conventional practice in the field of use.
Consideration of Additional Subject Matter of the Dependent Claims
Explicitly, regarding the additional subject matter added to the dependent claims, Claims 129-137 and 139-147, these additional limitations do not appear to further do not appear to further define the abstract idea to be significantly more.
With respect to Claims 129 and 139, the subject matter appears to be directed to the known disclosure of Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) considers “the quality of the mask-to-patient seal.” (Para 0159) as a function of “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” (Para 0144) in order to notify the user “adjust the fit of the mask” (“The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165). There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 130 and 140, Armitstead et al. (2011/0203588, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the occurrence of unintentional leak (“5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154) is determined based on a total flow rate (“the flow measured at the FG to give the sum of patient flow (respiratory flow)” Para 0153) and an vent flow (“calculate the flow through the vent in the mask (sometimes called intentional leak)” Para 0152). Additionally, the concept of leak detection is based in a mathematical relationship and/or calculation which is grouped as a mathematical concept under 2019 PEG. There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 131 and 141, Armitstead et al. (2011/0203588, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses when the occurrence of unintentional leak (“5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154) is determined based on a total flow rate (“the flow measured at the FG to give the sum of patient flow (respiratory flow)” Para 0153) being greater than the vent flow (“calculate the flow through the vent in the mask (sometimes called intentional leak)” Para 0152). Based on the aforementioned calculations, if the total flow rate was less than the average flow rate, then there would be no unintentional leak to filter from the system. Additionally, the concept of leak detection is based in a mathematical relationship and/or calculation which is ground as a mathematical concept under 2019 PEG. There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 132 and 142, Bassin (2015/0059755, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the features of operation over breaths and the use of a filter in the calculated data signals (“FIG. 7f is a flow chart illustrating a method 7600 that may be used to implement hypopnea detection as part of the algorithm 4325 in one form of the present technology. The method 7600 starts at step 7610, which applies a lowpass filter with a characteristic response time on the order of one or two typical breaths to the absolute value of airflow. In one implementation of step 7610, the lowpass filter is a second order Bessel lowpass filter, implemented digitally using the bilinear transform method, with a frequency response having its -3 dB point at 3.2/60 seconds. The output of step 7610 is denoted AbsAirflowFilterOutput.” Para 0223), whereby the leak flow is calculated “over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds.” (Paras 0141 and 0142) to achieve measured and gradual adjustments to the respiratory therapy system treatment operations (“This more than compensates for the mild reduction in prescriptiveness of the ventilator with respect to maintenance of target ventilation and respiratory rate in the very short term, over one or two breaths.” Para 0160). Additionally, the concept of leak detection is based in a mathematical relationship and/or calculation which is grouped as a mathematical concept under 2019 PEG. There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claim 133 and 143, Bassin (2015/0059755, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the leak characteristic curve calculation (“Leak Flow 4316 In one form of the present technology, a leak flow algorithm 4316 receives as an input a total flow, Qt, and a vent flow Qv, and provides as an output a leak flow Ql by calculating an average of Qt-Qv over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds. In one form, the leak flow algorithm 4316 receives as an input a total flow, Qt, a vent flow Qv, and an estimated pressure, Pm, in the patient interface 3000, and provides as an output a leak flow Ql by calculating a leak conductance, and determining a leak flow Ql to be a function of leak conductance and interface pressure, Pm. In one implementation, leak conductance is calculated as the quotient of low pass filtered non-vent flow Qt-Qv, and low pass filtered square root of mask pressure Pm, where the low pass filter time constant has a value sufficiently long to include several breathing cycles, e.g. about 10 seconds.” Para 0141-0142). Additionally, the equation recited in the claims based in a mathematical relationship and/or calculation which is grouped as a mathematical concept under 2019 PEG, and further is a mathematical formulation or equation whereby the determined solution is achieved by a determination, which is also grouped as a mental process under 2019 PEG. There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 134 and 144, Berthon-Jones (2006/0150974) discloses the consideration of diffuser loss (“The flow through the mask exhaust diffuser is calculated from the known parabolic resistance of the diffuser holes, and the square root of the mask pressure: diffuser flow=exhaust resistance*sign(mask pressure)*root(abs(mask pressure)) Finally, the mask flow is calculated: mask flow=sensor flow-diffuser flow ” Para 0202) in the calculation of leak (“Conductance of Leak The conductance of the leak is calculated as follows: root mask pressure=sign(P.sub.MASK) {square root over (abs(P.sub.MASK))} LP mask airflow=low pass filtered mask airflow LP root mask pressure=low pass filtered root mask pressure conductance of leak=LP mask airflow/LP root mask pressure The time constant for the two low pass filtering steps is initialized to 10 seconds and adjusted dynamically thereafter (see below). Instantaneous Flow Through Leak The instantaneous flow through the leak is calculated from the instantaneous mask pressure and the conductance of the leak: instantaneous leak=conductance of leak*root mask pressure Respiratory Airflow The respiratory airflow is the difference between the flow at the mask and the instantaneous leak: respiratory airflow=maskflow-instantaneous leak Low Pass Filtered Respiratory Airflow Low pass filter the respiratory airflow to remove cardiogenic airflow and other noise. … ” Para 0202). The resultant effect of this determination is the ability to properly ascertain the operational parameters of the respiratory therapy system. Additionally, the concept of leak detection is based in a mathematical relationship and/or calculation which is grouped as a mathematical concept under 2019 PEG. There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 135 and 145, Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses a determination based on the user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) with the respiratory therapy system (Figure 1), and provides a recommendation (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) to address the user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144). There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 136 and 146, Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the recommendation (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) is associated with user interface tightness (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165). There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
With respect to Claims 137 and 147, Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) discloses the recommendation (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) is presented (“displayed on the machine a message alerting the patient” Paras 0164 and 0165) to the user. There are no additional elements recited within this claim listing that would further define the abstract idea to be significant more in order to overcome the current rejection under 35 U.S.C. 101 abstract idea.
Additionally, with respect to Claims 137 and 147, it is noted Applicant’s specification does not include any discussion of how the “presentation” is significantly more than the concept of a generic alarm/display of the results or insignificant extra-solution activity realized by the claims over the prior art or any explanation as to how this gathering and analyzing of information utilizing conventional techniques and displaying the result is expressed in the claims. This is, like TLI Communications, the specification fails to provide sufficient detail regarding the manner of operation in which the claimed invention accomplishes any technical improvement or solution.
Therefore, the additional subject matter added to the dependent claims, Claims 129-137 and 139-147, retain the status of not being integrated into a practical application as the subject matter is not significantly more than the aforementioned abstract idea method and apparatus.
Conclusion of the 35 U.S.C. 101 Analysis
In light of the aforementioned reasoning, Claims 128-147 are deemed rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 128-131, 135-141, and 145-147 are rejected under 35 U.S.C. 103 as being obvious over Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) in view of Armitstead et al. (2011/0203588, which shares a common assignee with the instant invention but has a disclosure date before the grace period) and Ho et al. (2012/0247470).
As to Claims 128 and 138, Kwok discloses a method and system for determining a user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) with a respiratory therapy system (Figure 1), comprising: a flow rate sensor (4f, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053), wherein the flow rate sensor (4f) is configured to detect flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) associated with the respiratory therapy system (Figure 1); a pressure sensor (4p, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053), wherein the pressure sensor (4p) is configured to detect pressure values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) associated with the respiratory therapy device (Figure 1); a control system (15, “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t). The controller or processor is configured and adapted to perform the methodology described in more detail herein. The controller or processor may include integrated chips, a memory and/or other instruction or data storage medium to implement the control methodology.” Para 0056; also see: “The controller or processor 15 is further adapted to derive parameters indicative of the patient's breathing and sleep pattern, such as for deriving indications of flow limitation, such as flow flattening, snore, apnea and hypopnea and the Apnea Hypopnea Index (AHI), and for distinguishing between REM and non-REM sleep.” Para 0057; “If more than a predetermined number of successive--or cumulative--negative feedback responses are recorded, the controller will cause display of a message advising the patient to contact the clinician.” Para 0067; “Details of the patient feedback responses, and the treatment pressures may be stored in the controller for later review by the clinician.” Para 0068; “In an embodiment, the controller may be programmable by the clinician using the menu system to alter the parameters of the `first timer` mode, for example, to set the initial therapy session pressure and/or the daily pressure increment according to the severity of the patient's sleep disordered breathing and the clinician's opinion of how long the patient may take to acclimatize to the sensations of the CPAP therapy.” Para 0069), wherein the control system (15) is configured to: determine, based on a plurality of flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) and a plurality of pressure values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) corresponding to the plurality of flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) a leak characteristic curve (Figures 4 and 5, wherein “FIG. 4 is a graph of a mask pressure against blower set pressure, showing mask leak” Para 0048 and wherein “FIG. 5 is a flowchart illustrating mask leak control according to an embodiment of the invention” Para 0049; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “In a further embodiment of the invention, described with reference to FIGS. 4 and 5, the response of the blower to changes indicative of excessive air leakage at the patient interface is controlled for improved patient comfort and compliance and reduced possibility of disturbance.” Para 0143; “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) for the respiratory therapy system (Figure 1); determine, based on the leak characteristic curve (Figures 4 and 5), an occurrence of a leak (“FIG. 5 is a flowchart illustrating the steps of the mask leak control method according to an embodiment of the invention. At first detection of excessive mask leak (step 501), for example as determined by low mask pressure, by an excessive differential between the blower pressure and the pressure at the mask or by a computed mask impedance parameter below a certain threshold, the blower controller causes an increase in the blower pressure (step 502) to compensate for the leak and maintain the therapeutic pressure to desired levels, thus moving further to the right along the mask pressure curve of FIG. 4.” Paras 0149 and 0150; also see: Section “MASK LEAK CONTROL” Paras 0143-0169); and determine based on the occurrence of a leak, that the user interface (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) with the respiratory therapy system (Figure 1) exists.
Additionally, it is noted Kwok the intention of the data ascertained by the controller can be utilized to notify the user “adjust the fit of the mask” (“The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165).
Yet, Kwok does not expressly disclose the distinction between “an intentional leak” and “an unintentional leak” as claimed, whereby “determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system; determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak; and determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists” nor the configuration whereby “wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure”.
Regarding the remaining limitations to the distinction between “an intentional leak” and “an unintentional leak” as claimed, whereby “determine, based on a plurality of flow rate values and a plurality of pressure values corresponding to the plurality of flow rate values, an intentional leak characteristic curve for the respiratory therapy system; determine, based on the intentional leak characteristic curve, an occurrence of an unintentional leak; and determine, based on the occurrence of the unintentional leak, that the user interface issue with the respiratory therapy system exists”, was known.
Explicitly, Armitstead teaches a similar system for determining a user interface issue (via 406, “In reference to FIG. 4, the present technology involves a pressure delivery and/or flow limitation detection device that may include a flow generator such as a servo-controlled blower 402. The device will typically also include a patient interface such as a mask 406 and an air delivery conduit 408 to carry a flow of air or breathable gas to and/or from a patient. The blower 402 may be coupled with the air delivery conduit 408 and the mask 406.” Para 0077, whereby – “5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154) with the respiratory system (Figure 4), comprising: a flow rate sensor (404f, “Optionally, a flow sensor 404f and/or pressure sensor 404p may also be utilized. … The pressure sensor 404f and flow sensor 404p have only been shown symbolically in FIG. 4 since it is understood that other configurations and other devices may be implemented to measure flow and pressure. The flow F(t) and pressure P.sub.mask(t) signals may be sent to a controller or microprocessor 415 via one or more analog-to-digital (A/D) converters/samplers (not shown) to derive a pressure request signal P.sub.request(t).” Para 0077), a pressure sensor (404p, “Optionally, a flow sensor 404f and/or pressure sensor 404p may also be utilized. … The pressure sensor 404f and flow sensor 404p have only been shown symbolically in FIG. 4 since it is understood that other configurations and other devices may be implemented to measure flow and pressure. The flow F(t) and pressure P.sub.mask(t) signals may be sent to a controller or microprocessor 415 via one or more analog-to-digital (A/D) converters/samplers (not shown) to derive a pressure request signal P.sub.request(t).” Para 0077), and a control system (415, “The flow F(t) and pressure P.sub.mask(t) signals may be sent to a controller or microprocessor 415 via one or more analog-to-digital (A/D) converters/samplers (not shown) to derive a pressure request signal P.sub.request(t).” Para 0077, and “The controller or processor 415 is configured and adapted to implement the methodology or algorithms described in more detail herein and may include integrated chips, a memory and/or other control instruction, data or information storage medium.” Para 0079).
With respect to the remaining limitations of the claims, Armitstead teaches the explicit methodology utilized to identify a distinction between “an intentional leak” and “an unintentional leak” as claimed. Explicitly, Armitstead teaches “5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154).
In light of the teachings of Armitstead as modifying Kwok, the specific leak type of an unintentional leak, commonly known as mask or mouth leak, can be explicitly identified, as taught by Armitstead, and further utilized by the operations of Kwok to unequivocally notify the user of the necessity to “adjust the fit of the mask” (“The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) in order to yield “improved patient comfort and compliance and reduced possibility of disturbance.” (Para 0143) during respiratory therapy system treatments.
Regarding the configuration whereby “wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure”, Ho teaches the correlation between the intentional leak of the respiratory system and the corresponding flow rate for a given pressure was known.
Explicitly, Ho teaches a similar system for determining a user interface issue (58, “The pressurized flow of breathing gas, generally indicated by arrow D from gas flow generator 52, is delivered via delivery conduit 56 to patient interface device 58, which is typically worn by or otherwise attached to patient 54 to communicate the flow of breathing gas to the airway of patient 54. Delivery conduit 56 and patient interface device 58 are typically collectively referred to as a patient circuit.” Para 0022; “Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56. The pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56. Alternatively, the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.” Para 0027; “If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face.” Para 0032; “If the test failed at either step 102 or step 110, then patient 54 may be instructed (e.g., through input/output device 66) to manually input the mask type (e.g., as displayed on or with patient interface device 58) using input/output device 66.” Para 0035; “The example routine 100 provides a method of automatically identifying patient interface device 58 in use with pressure support system 50. This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037), including a flow rate sensor (62, “Pressure support system 50 further includes flow sensor 62 that measures the flow of the breathing gas within delivery conduit 56. Flow sensor 62 is interposed in line with delivery conduit 56, most preferably downstream of valve 60. Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54.” Para 0026; “Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “For example, routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68.” Para 0034; “This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040), a pressure sensor (68, “Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54. Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56.” Para 0027; “Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “For example, routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68.” Para 0034; “This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040), and a control system (64, “ Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54. Of course, other techniques for measuring the respiratory flow of patient 54 can be employed, such as measuring the flow directly at patient 54 or at other locations along delivery conduit 56 and communicating the measured flow by direct electrical connection between a flow sensor (not shown) and controller 64, measuring patient flow based on the operation of flow generator 52, and measuring patient flow using a flow sensor (not shown) upstream of valve 60.” Para 0026; “Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54. Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56. The pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56. Alternatively, the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.” Para 0027; “ Controller 64 may be, for example, a microprocessor, a microcontroller or some other suitable processor or processing device, that includes or is operatively coupled to a memory (not shown) that provides a storage medium for data and software executable by controller 64 for controlling the operation of pressure support system 50.” Para 0028; “FIG. 3 shows a routine 100 executed by processor 101 of controller 64 of FIG. 2. First, at step 102, it is determined if the mask auto detection is enabled. This can be, for example and without limitation, a configuration parameter of controller 64. If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face. Providing a specific instruction to the patient is optional if the system detects that the user already has placed the patient interface in communication with his or her airway.” Para 0032; “Next, at step 106, controller 64 functions to deliver specific pressure levels to patient 54 by controlling gas flow generator 52 and/or valve 60. Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “Finally, at step 114, controller 64 causes delivery of customized flow and pressure to patient 54 based upon the mask type. For example, controller 64 can control the pressure generator to provide pressure and flow to the mask based upon the type of mask.” Para 0034; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040).
Regarding the remaining limitations of the claims, Ho teaches “A patient interface device typically includes three different types of leaks: total, intentional, and unintentional. The total leak is the sum of the intentional leak and the unintentional leak.” (Para 0007); “It is known to determine and report the unintentional leak by measuring the total leak while the patient is using the patient interface device (e.g., which total leak can be measured at the beginning of the night) and then subtracting the intentional leak.” (Para 0008); whereby “the ventilator uses the corresponding intentional leak value (not shown) to subtract from the measured total leak in the calculation of the unintentional leak.” (Para 0009). In this configuration, as shown in Figure 1 there are a series of curvatures with correlate the flow rate of the intentional leak with the pressure as a function of the attached user interface (68). (See: Paras 0009 and 0054).
In light of the teachings of Ho, the modification of the control system to output an intentional leak curve as a function of the flow rate and pressure applied to the user interface is a known modification in order to determine the efficacy of the user interface types to achieve a desired constant leak.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the leak characteristic curve based on the plurality of flow rate values and plurality of pressure values of Kwok, to make a distinction between the intentional leak and the unintentional leak, as taught by Armitstead to ensure the type of leak is unequivocally an unintentional leak, commonly known as mask or mouth leak, in order to improve patient comfort and compliance and reduced possibility of disturbance, and to modify the plotting of the characteristic curve of Kwok to measure the intentional leak as a function of the corresponding flow rate and pressure, as taught by Ho to determine the efficacy of the user interface types to achieve a desired constant leak.
As to Claims 129 and 139, the modified Kwok, specifically Kwok discloses the user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) is an issue (“quality of the mask-to-patient seal.” Para 0159) is associated with a user position (“the mask is not sitting properly and sealing completely on the patient's face” Para 0144), user interface tightness (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165).
As to Claims 130 and 140, the modified Kwok, specifically Armitstead teaches the occurrence of unintentional leak (“5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154) is determined based on a total flow rate (“the flow measured at the FG to give the sum of patient flow (respiratory flow)” Para 0153) and an vent flow (“calculate the flow through the vent in the mask (sometimes called intentional leak)” Para 0152).
Yet, although the modified Kwok, specifically Armistead does not expressly disclose the use of an “average vent flow”, the use of an “average” over a period of time rather than an instantaneous data point is obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to make pressure adjustments based on a running average rather than an instantaneous data point so that the change in pressure adjustments is measured and gradual to affirm the patient’s comfort and compliance.
Further, it should be noted that Armistead does acknowledge consideration of “average” and “mean” values in the operation of the respiratory therapy system was known, discussed, and considered with pros and cons by Armistead (“The breath duty cycle measure may be a ratio such as a ratio of a current breath inspiration time to breath cycle time ratio and a prior average breath inspiration time to breath cycle time ratio.” Para 0016; “In order to reduce the effects of noise and increase specificity, a typical pressure setting algorithm may also use a five breath point-wise moving average.” Para 0068; “ 1. A five-breath moving average slows down the detection of flow-limitation. This is illustrated in FIG. 2. In FIG. 2, the top trace shows a plot of a traditional five-breath moving-average flattening index. The bottom trace shows a measure of respiratory flow. The patient begins to obstruct mildly and the flattening trace descends in staircase fashion at 202 due to the five-breath average.” Para 0070; “2. Because different inspiratory shapes can average to give a completely new shape, the five breath moving average can have consequences.” Para 0071; “14. This final FFL value may optionally be used in a ring buffer of a length, such as three, and the value of FFL that is ultimately used by a pressure setting algorithm can be based on a running average of the most recent FFL values of the buffer.” Para 0145; “In order to allow for the fact that breaths might not be four seconds in length, a breath detection algorithm may be used to get the current respiration rate (RR, breaths per minute) which can be determined as an average of the five most recent breaths detected.” Para 0243).
As Applicant has not asserted the specific use of an “average vent flow” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of enabling a gradual change of data points as compared to an instantaneous change in data points, the use of the specific “average vent flow” appears to lack criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Kwok, as the use of an “average vent flow” would yield the predictable results of making measured and gradual adjustments to the respiratory therapy system treatment operations rather than rapid and dynamic adjustments which may hinder the patient’s comfort and/or compliance.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the modified Kwok to include the use of an “average vent flow”, a known result effective variable, in order to permit measured and gradual adjustments to the respiratory therapy system treatment operations rather than rapid and dynamic adjustments which may hinder the patient’s comfort and/or compliance.
As to Claims 131 and 141, the modified Kwok, specifically Armitstead teaches considers the use of an “average vent flow” whereby when the occurrence of unintentional leak (“5. Using the pressure at the mask, calculate the flow through the vent in the mask (sometimes called intentional leak). 6. Subtract the vent flow from the flow measured at the FG to give the sum of patient flow (respiratory flow) plus any unintentional (mask or mouth) leak. 7. Filter the signal from step 6 to extract the DC (unintentional leak) component.” Paras 0152-0154) is determined based on a total flow rate (“the flow measured at the FG to give the sum of patient flow (respiratory flow)” Para 0153) being greater than the vent flow (“calculate the flow through the vent in the mask (sometimes called intentional leak)” Para 0152). Based on the aforementioned calculations, if the total flow rate was less than the average flow rate, then there would be no unintentional leak to filter from the system.
As to Claims 135 and 145, the modified Kwok, specifically Kwok discloses a determination based on the user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144) with the respiratory therapy system (Figure 1), and provides a recommendation (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) to address the user interface issue (via 6, “For example, FIG. 1 illustrates a ventilator device according to an embodiment of the invention. As illustrated, the ventilator device may include a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, and an air delivery conduit 8 for connection between the blower 2 and the mask 6.” Para 0053; whereby – “The controller may be programmed to make one or more further attempts to ramp up blower pressure after a predetermined time periods, for example 15 minutes, have elapsed to reassess the quality of the mask-to-patient seal.” Para 0159; also see: Section “MASK LEAK CONTROL” Paras 0143-0169, in particular: “FIG. 4 is a schematic graph of mask pressure against flow generator pressure illustrating mask leak where the mask is not sitting properly and sealing completely on the patient's face, for example where the mask and headgear has not been optimally adjusted or where the patient may have partially dislodged the mask during sleep.” Para 0144).
As to Claims 136 and 146, the modified Kwok, specifically Kwok discloses the recommendation (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) is associated with user interface tightness (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165).
As to Claims 137 and 147, the modified Kwok, specifically Kwok discloses the recommendation (“adjust the fit of the mask”, “The controller keeps a record of incidents where the blower pressure is reduced in response to excessive mask leak, for subsequent review by the clinician to help with mask selection and adjustment for the patient. Also, at the end of a session where excessive mask leak has been detected, the controller may cause to be displayed on the machine a message alerting the patient to the need to adjust the fit of the mask, and/or to contact the clinician.” Paras 0164 and 0165) is presented (“displayed on the machine a message alerting the patient” Paras 0164 and 0165) to the user.
Claims 132, 133, 142, and 143 are rejected under 35 U.S.C. 103 as being obvious over Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) in view of Armitstead et al. (2011/0203588, which shares a common assignee with the instant invention but has a disclosure date before the grace period) and Ho et al. (2012/0247470), as applied to Claims 128 and 138, and further in view of Bassin (2015/0059755, which shares a common assignee with the instant invention but has a disclosure date before the grace period).
As to Claims 132 and 142, the modified Kwok, specifically Kwok discloses the controller (15) concerned with a plurality of flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) and a plurality of pressure values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056); and specifically Armitstead teaches the distinction between leak types of “unintentional leak” and “intentional leak”.
Yet, does not expressly disclose the steps to “receive, the plurality of flow rate values, wherein the plurality of flow rate values are associated with pressurized air directed to an airway of a user of the respiratory therapy system; receive the plurality of pressure values, wherein the plurality of pressure values are associated with the pressurized air directed to the airway of the user, each of the plurality of pressure values corresponding to a respective one of the plurality of flow rate values; identify a first time associated with a first breath of the user and a second time associated with a second breath of the user; filter the plurality of flow rate values based at least in part on the identified first time and the identified second time, the filtering producing a subset of the plurality of flow rate values; and wherein the intentional leak characteristic curve is determined using at least two of the subset of the plurality of values and the corresponding pressure values for the at least two of the subset of the plurality of flow rate values.”
Bassin teaches a system for determining a user interface issue (via 3000, “FIG. 1a shows a system in accordance with the present technology. A patient 1000 wearing a patient interface 3000, receives a supply of air at positive pressure from a PAP device 4000. Air from the PAP device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.” Para 0052; also see: Paras 0073, 0077-0099, 0139-0142, and 0150; wherein leak is determined “Leak Flow 4316 In one form of the present technology, a leak flow algorithm 4316 receives as an input a total flow, Qt, and a vent flow Qv, and provides as an output a leak flow Ql by calculating an average of Qt-Qv over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds. In one form, the leak flow algorithm 4316 receives as an input a total flow, Qt, a vent flow Qv, and an estimated pressure, Pm, in the patient interface 3000, and provides as an output a leak flow Ql by calculating a leak conductance, and determining a leak flow Ql to be a function of leak conductance and interface pressure, Pm. In one implementation, leak conductance is calculated as the quotient of low pass filtered non-vent flow Qt-Qv, and low pass filtered square root of mask pressure Pm, where the low pass filter time constant has a value sufficiently long to include several breathing cycles, e.g. about 10 seconds.” Para 0141-0142) with a respiratory therapy system (Figure 1a), comprising: a flow rate sensor (4274, “A flow transducer 4274 … In use, a signal or total flow Qt signal, from the flow transducer 4274, is received by the processor 4230.” Paras 0122-0123), a pressure sensor (4272, “A pressure transducer 4272 … In use, a signal from the pressure transducer 4272, is received by the processor 4230.” Para 0124-0125), and a control system (4230, “Central Controller 4230” Para 0081, “The central controller 4230 of the PAP device 4000 is programmed to execute one or more algorithm modules 4300, including in one implementation a pre-processing module 4310, a therapy engine module 4320, a pressure control module 4330, and a fault condition module 4340.” Para 0082, Paras 0102-0113; also see: “In use, a signal or total flow Qt signal, from the flow transducer 4274, is received by the processor 4230.” Para 0123 and “In use, a signal from the pressure transducer 4272, is received by the processor 4230.” Para 0125).
Regarding the remaining limitations to “receive, the plurality of flow rate values, wherein the plurality of flow rate values are associated with pressurized air directed to an airway of a user of the respiratory therapy system; receive the plurality of pressure values, wherein the plurality of pressure values are associated with the pressurized air directed to the airway of the user, each of the plurality of pressure values corresponding to a respective one of the plurality of flow rate values; identify a first time associated with a first breath of the user and a second time associated with a second breath of the user; filter the plurality of flow rate values based at least in part on the identified first time and the identified second time, the filtering producing a subset of the plurality of flow rate values; and wherein the intentional leak characteristic curve is determined using at least two of the subset of the plurality of values and the corresponding pressure values for the at least two of the subset of the plurality of flow rate values”, Bassin teaches the features of operation over breaths and the use of a filter in the calculated data signals (“FIG. 7f is a flow chart illustrating a method 7600 that may be used to implement hypopnea detection as part of the algorithm 4325 in one form of the present technology. The method 7600 starts at step 7610, which applies a lowpass filter with a characteristic response time on the order of one or two typical breaths to the absolute value of airflow. In one implementation of step 7610, the lowpass filter is a second order Bessel lowpass filter, implemented digitally using the bilinear transform method, with a frequency response having its -3 dB point at 3.2/60 seconds. The output of step 7610 is denoted AbsAirflowFilterOutput.” Para 0223), whereby the leak flow is calculated “over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds.” (Paras 0141 and 0142) to achieve measured and gradual adjustments to the respiratory therapy system treatment operations (“This more than compensates for the mild reduction in prescriptiveness of the ventilator with respect to maintenance of target ventilation and respiratory rate in the very short term, over one or two breaths.” Para 0160).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manner of determining the intentional leak characteristic curve of the modified Kwok, based on the use of a series of breaths and filtering of the data signals as taught by Bassin to provide a measured and gradual adjustments to the respiratory therapy system treatment operations.
As to Claims 133 and 143, the modified Kwok, specifically Bassin teaches the leak characteristic curve calculation (“Leak Flow 4316 In one form of the present technology, a leak flow algorithm 4316 receives as an input a total flow, Qt, and a vent flow Qv, and provides as an output a leak flow Ql by calculating an average of Qt-Qv over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds. In one form, the leak flow algorithm 4316 receives as an input a total flow, Qt, a vent flow Qv, and an estimated pressure, Pm, in the patient interface 3000, and provides as an output a leak flow Ql by calculating a leak conductance, and determining a leak flow Ql to be a function of leak conductance and interface pressure, Pm. In one implementation, leak conductance is calculated as the quotient of low pass filtered non-vent flow Qt-Qv, and low pass filtered square root of mask pressure Pm, where the low pass filter time constant has a value sufficiently long to include several breathing cycles, e.g. about 10 seconds.” Para 0141-0142).
Claims 134 and 144 are rejected under 35 U.S.C. 103 as being obvious over Kwok et al. (2009/0205662, which shares a common assignee with the instant invention but has a disclosure date before the grace period) in view of Armitstead et al. (2011/0203588, which shares a common assignee with the instant invention but has a disclosure date before the grace period) and Ho et al. (2012/0247470), as applied to Claims 128 and 138, and further in view of Berthon-Jones (2006/0150974).
As to Claims 134 and 144, the modified Kwok, specifically Kwok discloses the controller (15) concerned with a plurality of flow rate values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056) and a plurality of pressure values (“The device also includes a flow sensor to measure the flow of air along the conduit, and pressure sensors to measure the pressure of air at the blower outlet.” Para 0051; also see: “Flow F(t) and pressure P.sub.mask(t) signals are sent to a controller or microprocessor--referred to herein as processor 15--to derive a pressure request signal P.sub.Request(t).” Para 0056); and specifically Armitstead teaches the distinction between leak types of “unintentional leak” and “intentional leak”.
Yet, does not expressly disclose the step to “determine, based at least in part on the determined intentional leak characteristic curve, a diffuser loss.”
Berthon-Jones teaches a system for determining a user interface issue (via 11, “Apparatus to give effect to a first embodiment of the apparatus is shown in FIG. 1a. A blower 10 supplies a breathable gas to mask 11 in communication with the subject's airway via a delivery tube 12 and exhausted via a exhaust diffuser 13. Airflow to the mask 11 is measured using a pneumotachograph 14 and a differential pressure transducer 15. The mask flow signal from the transducer 15 is then sampled by a microprocessor 16. Mask pressure is measured at the port 17 using a pressure transducer 18. The pressure signal from the transducer 18 is then sampled by the microprocessor 16. The microprocessor 16 sends an instantaneous mask pressure request signal to the servo 19, which compares said pressure request signal with actual pressure signal from the transducer 18 to the control fan motor 20. The microprocessor settings can be adjusted via a serial port 21.” Para 0126; whereby leak is determined “3. Calculate the mean leak as the low pass filtered airflow, with a time constant long compared with a breath. … 5. Calculate the modulation of the flow through the leak as: .delta.(leak)=0.5 times the mean leak times the inducing pressure, where the inducing pressure is P.sub.MASK-mean mask pressure. Thence the instantaneous respiratory airflow can be calculated as: f.sub.RESP=f.sub.MASK-mean leak-.delta.(leak)” Paras 0166-0168) with a respiratory therapy system (Figure 1a), comprising: a flow rate sensor (via 14 and 15, “Airflow to the mask 11 is measured using a pneumotachograph 14 and a differential pressure transducer 15. The mask flow signal from the transducer 15 is then sampled by a microprocessor 16.” Para 0126), a pressure sensor (18, “ Mask pressure is measured at the port 17 using a pressure transducer 18. The pressure signal from the transducer 18 is then sampled by the microprocessor 16. The microprocessor 16 sends an instantaneous mask pressure request signal to the servo 19, which compares said pressure request signal with actual pressure signal from the transducer 18 to the control fan motor 20.” Para 0126), and a control system (16, “a microprocessor 16” Para 0126).
Regarding the remaining limitation to “determine, based at least in part on the determined intentional leak characteristic curve, a diffuser loss”, Berthon-Jones teaches the consideration of diffuser loss (“The flow through the mask exhaust diffuser is calculated from the known parabolic resistance of the diffuser holes, and the square root of the mask pressure: diffuser flow=exhaust resistance*sign(mask pressure)*root(abs(mask pressure)) Finally, the mask flow is calculated: mask flow=sensor flow-diffuser flow ” Para 0202) in the calculation of leak (“Conductance of Leak The conductance of the leak is calculated as follows: root mask pressure=sign(P.sub.MASK) {square root over (abs(P.sub.MASK))} LP mask airflow=low pass filtered mask airflow LP root mask pressure=low pass filtered root mask pressure conductance of leak=LP mask airflow/LP root mask pressure The time constant for the two low pass filtering steps is initialized to 10 seconds and adjusted dynamically thereafter (see below). Instantaneous Flow Through Leak The instantaneous flow through the leak is calculated from the instantaneous mask pressure and the conductance of the leak: instantaneous leak=conductance of leak*root mask pressure Respiratory Airflow The respiratory airflow is the difference between the flow at the mask and the instantaneous leak: respiratory airflow=maskflow-instantaneous leak Low Pass Filtered Respiratory Airflow Low pass filter the respiratory airflow to remove cardiogenic airflow and other noise. … ” Para 0202). The resultant effect of this determination is the ability to properly ascertain the operational parameters of the respiratory therapy system.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the control system of the modified Kwok to include a consideration of diffuser loss in the calculation of leak, as taught by Berthon-Jones to determine the operational parameters of the respiratory therapy system.
Response to Arguments
Applicant’s arguments with respect to claims, with respect to the rejection under 35 U.S.C. 101, have been considered but are moot.
Applicant asserts the positive recitation of the “flow rate sensor” and the “pressure sensor” in the independent claim, Claim 128, overcome the rejection under 35 U.S.C. 101. (Remarks, Page 16/21, Paragraphs 1 and 2). However, it should be noted this amendment although clarifying does not overcome the rejection of the claims under 35 U.S.C. 101 as the other independent claim, Claim 138, already considered the usage of each of the “flow rate sensor” an the “pressure sensor” in the determination of a user interface issue.
Regarding the additional limitations incorporated in both independent claims, Claims 128 and 138, reciting “wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure”, it should be noted this limitation is simply a manipulation of a mathematical formulation or equation to achieve a plot and/or graphical representation of the curvature – as shown in Figure 1 of Ho et al. (2012/0247470). It is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Ho teaches a similar system for determining a user interface issue (58, “The pressurized flow of breathing gas, generally indicated by arrow D from gas flow generator 52, is delivered via delivery conduit 56 to patient interface device 58, which is typically worn by or otherwise attached to patient 54 to communicate the flow of breathing gas to the airway of patient 54. Delivery conduit 56 and patient interface device 58 are typically collectively referred to as a patient circuit.” Para 0022; “Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56. The pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56. Alternatively, the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.” Para 0027; “If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face.” Para 0032; “If the test failed at either step 102 or step 110, then patient 54 may be instructed (e.g., through input/output device 66) to manually input the mask type (e.g., as displayed on or with patient interface device 58) using input/output device 66.” Para 0035; “The example routine 100 provides a method of automatically identifying patient interface device 58 in use with pressure support system 50. This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037), including a flow rate sensor (62, “Pressure support system 50 further includes flow sensor 62 that measures the flow of the breathing gas within delivery conduit 56. Flow sensor 62 is interposed in line with delivery conduit 56, most preferably downstream of valve 60. Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54.” Para 0026; “Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “For example, routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68.” Para 0034; “This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040), a pressure sensor (68, “Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54. Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56.” Para 0027; “Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “For example, routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68.” Para 0034; “This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040), and a control system (64, “ Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54. Of course, other techniques for measuring the respiratory flow of patient 54 can be employed, such as measuring the flow directly at patient 54 or at other locations along delivery conduit 56 and communicating the measured flow by direct electrical connection between a flow sensor (not shown) and controller 64, measuring patient flow based on the operation of flow generator 52, and measuring patient flow using a flow sensor (not shown) upstream of valve 60.” Para 0026; “Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54. Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56. The pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56. Alternatively, the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.” Para 0027; “ Controller 64 may be, for example, a microprocessor, a microcontroller or some other suitable processor or processing device, that includes or is operatively coupled to a memory (not shown) that provides a storage medium for data and software executable by controller 64 for controlling the operation of pressure support system 50.” Para 0028; “FIG. 3 shows a routine 100 executed by processor 101 of controller 64 of FIG. 2. First, at step 102, it is determined if the mask auto detection is enabled. This can be, for example and without limitation, a configuration parameter of controller 64. If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face. Providing a specific instruction to the patient is optional if the system detects that the user already has placed the patient interface in communication with his or her airway.” Para 0032; “Next, at step 106, controller 64 functions to deliver specific pressure levels to patient 54 by controlling gas flow generator 52 and/or valve 60. Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “Finally, at step 114, controller 64 causes delivery of customized flow and pressure to patient 54 based upon the mask type. For example, controller 64 can control the pressure generator to provide pressure and flow to the mask based upon the type of mask.” Para 0034; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040).
Regarding the remaining limitations of the claims, Ho teaches “A patient interface device typically includes three different types of leaks: total, intentional, and unintentional. The total leak is the sum of the intentional leak and the unintentional leak.” (Para 0007); “It is known to determine and report the unintentional leak by measuring the total leak while the patient is using the patient interface device (e.g., which total leak can be measured at the beginning of the night) and then subtracting the intentional leak.” (Para 0008); whereby “the ventilator uses the corresponding intentional leak value (not shown) to subtract from the measured total leak in the calculation of the unintentional leak.” (Para 0009). In this configuration, as shown in Figure 1 there are a series of curvatures with correlate the flow rate of the intentional leak with the pressure as a function of the attached user interface (68). (See: Paras 0009 and 0054).
In light of the teachings of Ho, the modification of the control system to output an intentional leak curve as a function of the flow rate and pressure applied to the user interface is a known modification in order to determine the efficacy of the user interface types to achieve a desired constant leak.
Thus, the explicit axis of the intentional leak curve having a flow rate and corresponding pressure is not significantly more and does not appear to thrust the claim listing beyond to overcome the rejection under 35 U.S.C. 101.
Applicant’s arguments with respect to claims, with respect to the rejection under 35 U.S.C. 103, have been considered but are moot.
Although Primary Examiner appreciates the further limitation incorporation the features of “wherein the intentional leak characteristic curve defines an intentional leak of the respiratory therapy system by providing a corresponding flow rate of the intentional leak for a given pressure” into the independent claims, Claims 128 and 138, these limitations appear to have been taught by Figure 1 of Ho et al. (2012/0247470).
Ho teaches a similar system for determining a user interface issue (58, “The pressurized flow of breathing gas, generally indicated by arrow D from gas flow generator 52, is delivered via delivery conduit 56 to patient interface device 58, which is typically worn by or otherwise attached to patient 54 to communicate the flow of breathing gas to the airway of patient 54. Delivery conduit 56 and patient interface device 58 are typically collectively referred to as a patient circuit.” Para 0022; “Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56. The pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56. Alternatively, the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.” Para 0027; “If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face.” Para 0032; “If the test failed at either step 102 or step 110, then patient 54 may be instructed (e.g., through input/output device 66) to manually input the mask type (e.g., as displayed on or with patient interface device 58) using input/output device 66.” Para 0035; “The example routine 100 provides a method of automatically identifying patient interface device 58 in use with pressure support system 50. This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037), including a flow rate sensor (62, “Pressure support system 50 further includes flow sensor 62 that measures the flow of the breathing gas within delivery conduit 56. Flow sensor 62 is interposed in line with delivery conduit 56, most preferably downstream of valve 60. Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54.” Para 0026; “Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “For example, routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68.” Para 0034; “This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040), a pressure sensor (68, “Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54. Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56.” Para 0027; “Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “For example, routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68.” Para 0034; “This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.” Para 0037; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040), and a control system (64, “ Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54. Of course, other techniques for measuring the respiratory flow of patient 54 can be employed, such as measuring the flow directly at patient 54 or at other locations along delivery conduit 56 and communicating the measured flow by direct electrical connection between a flow sensor (not shown) and controller 64, measuring patient flow based on the operation of flow generator 52, and measuring patient flow using a flow sensor (not shown) upstream of valve 60.” Para 0026; “Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54. Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56. The pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56. Alternatively, the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.” Para 0027; “ Controller 64 may be, for example, a microprocessor, a microcontroller or some other suitable processor or processing device, that includes or is operatively coupled to a memory (not shown) that provides a storage medium for data and software executable by controller 64 for controlling the operation of pressure support system 50.” Para 0028; “FIG. 3 shows a routine 100 executed by processor 101 of controller 64 of FIG. 2. First, at step 102, it is determined if the mask auto detection is enabled. This can be, for example and without limitation, a configuration parameter of controller 64. If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face. Providing a specific instruction to the patient is optional if the system detects that the user already has placed the patient interface in communication with his or her airway.” Para 0032; “Next, at step 106, controller 64 functions to deliver specific pressure levels to patient 54 by controlling gas flow generator 52 and/or valve 60. Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.” Para 0033; “Finally, at step 114, controller 64 causes delivery of customized flow and pressure to patient 54 based upon the mask type. For example, controller 64 can control the pressure generator to provide pressure and flow to the mask based upon the type of mask.” Para 0034; and “As can be seen, for example, with reference to FIGS. 1 and 3, if the test at step 110 passes, then at step 112, routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).” Para 0040).
Regarding the remaining limitations of the claims, Ho teaches “A patient interface device typically includes three different types of leaks: total, intentional, and unintentional. The total leak is the sum of the intentional leak and the unintentional leak.” (Para 0007); “It is known to determine and report the unintentional leak by measuring the total leak while the patient is using the patient interface device (e.g., which total leak can be measured at the beginning of the night) and then subtracting the intentional leak.” (Para 0008); whereby “the ventilator uses the corresponding intentional leak value (not shown) to subtract from the measured total leak in the calculation of the unintentional leak.” (Para 0009). In this configuration, as shown in Figure 1 there are a series of curvatures with correlate the flow rate of the intentional leak with the pressure as a function of the attached user interface (68). (See: Paras 0009 and 0054).
In light of the teachings of Ho, the modification of the control system to output an intentional leak curve as a function of the flow rate and pressure applied to the user interface is a known modification in order to determine the efficacy of the user interface types to achieve a desired constant leak.
Therefore, the further modification of Kwok in view of Armistead and Ho appears to teach the newly added features of the claim listing. Thus, Claims 128-147 remain rejection and made FINAL.
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.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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