DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 01/20/2026. As directed by the amendment, claims 43-57 and 59-62 have been amended. As such, claims 43-62 are pending in the instant application.
Applicant has amended claims 53; the objection to the claim has been withdrawn as the language has been removed.
Response to Arguments
Applicant's arguments, see pages 8-11 of Remarks, filed 01/20/2026, pertaining to the
35 USC 101 recites “the claimed technology "is advantageous in that it allows the accurate setting of a fault boundary regardless of the configuration of the breathing system."” Applicant further argues that a human cannot perform measuring via a sensor within Step 2A, Prong one, the pending claims recite additional elements that are integrated into a practical application in Step 2A, Prong Two and the pending claims clearly recite meaningful and specific limitations that satisfy the second part of the eligibility analysis set forth in the 2014 Guidelines. The examiner is not persuaded. The examiner directed the sensor to be an additional element of Step 2A, Prong 2 and only discussed “setting a fault boundary for the first parameter” and “updating the fault boundary, the updated fault boundary being dependent on an updated set of measurements of the first parameter, the updated set of measurements of the first parameter including at least one of the further measurements of the first parameter” in the form of “mental processes,” in terms of processes that can be performed in the human mind. The examiner would further like to point out the claim is still missing a practical application. Although claim 43 has been amended to output an indication of the fault, the output of the fault does not affect the operation of the system (e.g. after indicating the fault, the breathing system is to adjust its parameters and/or method of operation and/or state of operation accordingly as seen on page 8, last paragraph to page 9, first paragraph of applicant’s specification).
Applicant's arguments, see pages 12-14 of Remarks, filed 01/20/2026, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been provided below to address the newly added limitations.
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 43-62 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 43 is directed to “a respiratory apparatus,” (i.e. a machine) and claim(s) 59 and 60 are directed to “a method,” (i.e. a process), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
However, the claims are drawn to an abstract idea of “setting a fault boundary for the first parameter,” “updating the fault boundary, the updated fault boundary being dependent on an updated set of measurements of the first parameter, the updated set of measurements of the first parameter including at least one of the further measurements of the first parameter” and “determine whether there is a fault with an operation of the breathing system based on a comparison of a measurement of the first parameter with the fault boundary or the updated fault boundary” in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion).
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea. In other words, Step 2A, Prong 1 of the subject-matter eligibility analysis is “Yes.”
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “a respiratory apparatus,” “at least one sensor,” “a controller,” and ”a breathing system,” are merely claimed to generally link the use of a judicial exception (e.g., pre-solution activity of data gathering and post-solution activity of presenting data) to (1) a particular technological environment or (2) field of use, per MPEP §2106.05(h); and are applying the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, per MPEP §2106.05(f). In other words, the claimed “setting a fault boundary for the first parameter,” “updating the fault boundary, the updated fault boundary being dependent on an updated set of measurements of the first parameter, the updated set of measurements of the first parameter including at least one of the further measurements of the first parameter” and “determine whether there is a fault with an operation of the breathing system based on a comparison of a measurement of the first parameter with the fault boundary or the updated fault boundary” is not providing a practical application, thus Step 2A, Prong 2 of the subject-matter eligibility analysis is “No.”
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “a respiratory apparatus,” “at least one sensor,” “a controller,” and” breathing system,” are claimed, these are generic, well-known, and conventional elements. As evidence that these are generic, well-known, and a conventional elements (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known, the Applicant’s specification discloses these in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a). As such, this satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
The element of “a respiratory apparatus supplying gas” is described on page 10, lines 9-13, states: “In use, the breathing system may be connected to an apparatus for supplying gas, which may comprise a gas bottle or cannister, or a fixed gas line in a hospital wall, for example.” As such, the element can be any generic gas bottle, cannister or a fixed gas line in the art that can be used with the device and therefore can be any generic and conventional gas bottle, cannister or a fixed gas line.
Similarly, the element of ““at least one sensor” is described on page 15, lines 28-32, as follows “Measuring the first parameter may comprise measuring the first parameter using at least one sensor. The at least one sensor may comprise a plurality of sensors positioned at different positions throughout the device and each measurement of the first parameter may comprise taking an instantaneous average of the measurements measured by the plurality of sensors. This element is a generic plurality of sensors used to measure a parameter with no description beyond what is otherwise known to be in existence.
Moreover, the element of “a controller” is described on page 20, line 19 as follows: “The controller may comprise a processor.” This element is reasonably interpreted as a processor with no details of anything beyond ubiquitous standard equipment.
The element of “a breathing system,” is described on page 21, lines 30-34 as follows: “The breathing system may comprise a patient interface for providing the gas supply to a patient. The breathing system may comprise a breathing tube arranged to deliver the gas supply from the outlet to the patient interface.” Patient interfaces and breathing tubes are generic and known in the art to be provided with a flow of gas towards the patient as taught by Duff (US 6269811 B1) which recites “It is conventional to introduce the supplemental flow of gas into the conduit or at the patient interface device, both of which are downstream of the pressure generator in the pressure generating system (see Col. 1, lines 64-67).”
As such, the elements of “a respiratory apparatus,” “at least one sensor,” “a controller,” and “a breathing system,” are reasonably understood as ubiquitous standard equipment within modern computers/inhalers having generic, well-known, and conventional elements and the elements do not provide anything significantly more. Therefore, Step 2B, of the subject-matter eligibility analysis is “No.”
In addition, dependent claims 44-58 and 61-62 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 44-58 and 61-62 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to claim 1 or 31. Therefore, claims 43-62 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 43-44, 46-47, 52-54 and 56-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brand (US 20160287823 A1) in view of Gottlib (US 20080053441 A1).
Regarding claim 43, Brand teaches a respiratory apparatus (pressure generator 14, sensor 18 and processor 22, see Fig. 1) for monitoring a breathing system (system 10, see Fig. 1) (Brand teaches one or more sensors 18 to output or more output signals conveying information related to one or more parameters of the pressurized flow of breathable gas as seen in Fig. 4 and [0022]), the respiratory apparatus comprising:
at least one sensor (one or more sensors 18, see Fig. 1) configured to take a series of measurements of a first parameter of the breathing system after a gas is first supplied to the breathing system (Brand teaches one or more sensors 18 to convey one or more output signals conveying information related to one or more parameters of the pressurized flow of breathable gas as seen in [0022]. Brand further teaches method 400 with at operation 402 a pressurized flow of breathable gas is generated before operation 404 of generating outputting signals conveying information related to gas parameters as seen in Fig. 4 and [0047]), the at least one sensor configured, in at least one update procedure, to take one or more further measurements of the first parameter (Brand teaches operation 408 of adjusting/updating the first negative pressure level based on the output signals as seen in Fig. 4 and [0049]), wherein the first parameter comprises or is indicative of flow rate, back pressure within the breathing system, or patient pressure (Brand teaches sensors 18 to output signals indicative of one or more of a flow rate or a pressure as seen in [0022]); and
a controller (processor 22, see Fig. 1) configured to:
set a level for the first parameter, the level being dependent on a first plurality of the series of measurements of the first parameter (Brand teaches parameter module 30 to determine one or more parameters based on the output signals of sensors 18 and further teaches the pressure generator is controlled to provide the pressurized flow of breathable gas at a first negative pressure level based on the output signals as seen in [0028], [0037] and [0048]. As such, Brand teaches setting the negative pressure level based on the one or more parameters based on the output signals),
in the at least one update procedure, update the level, the updated level dependent on an updated set of measurements of the first parameter, the updated set of measurements of the first parameter including at least one of the one or more further measurements of the first parameters (Brand teaches the sensors 18 generating output signals in operation 404 and further teaches operation 408 wherein the first negative pressure level is adjusted with the titration module based on the output signals (and as such the updated/adjusted negative pressure level depends on updated measurements/output signals) as seen in Fig. 4 and [0037] and [0049])
But does not teach set a fault boundary for the first parameter, the fault boundary being dependent on a first plurality of the series of measurements of the first parameter,
automatically determine whether there is a fault with an operation of the breathing system based on a comparison of a measurement of the first parameter with the fault boundary or the updated fault boundary; and
in response to determining the fault, output an indication of the fault.
However, Gottlib teaches set a fault boundary for the first parameter (Gottlib teaches pressure detector 42 to detect a pressure of gas as seen in [0023], wherein the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Fig. 3a and [0039]), the fault boundary being dependent on a first plurality of the series of measurements of the first parameter (Gottlib teaches the pressure error threshold value can be determined based on starting pressure as seen in [0047], and therefore is dependent on a first plurality of measurements);
automatically determine whether there is a fault with an operation of the breathing system based on a comparison of a measurement of the first parameter with the fault boundary or the updated fault boundary (Gottlib teaches fault detection system 46 wherein the measured pressured is subtracted from a target pressure through a subtractor 60a giving a pressure error value as seen in Fig. 3a and [0039]. The pressure error value is then sent through a filter 62a before being compared to a pressure error threshold value to indicate whether or not a fault condition has been detected as seen in Fig. 3a and [0040]); and
in response to determining the fault, output an indication of the fault (Gottlib teaches generating an alert detectable by a human when the fault detection system 46 detects that a fault condition exists as seen in Fig.4 and [0026], [0044] and [0060]).
Brand teaches a negative pressure level based on the output of signals as seen in [0028], [0037] and [0048]. Gottlib teaches wherein the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Fig. 3a and [0039]-[0040]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Brand to include the fault detection system as taught by Gottlib to detect operational faults that can lead to injury or cause mechanical stresses within the breathing device (see [0003]).
Regarding claim 44, Brand in view of Gottlib teaches the apparatus of claim 43, and Gottlib further teaches wherein the controller is further configured to set the fault boundary for the first parameter to be offset from a measurement parameter that is dependent on one or more of the first plurality of the series of measurements of the first parameter or a second plurality of the series of measurements of the first parameter (Gottlib teaches the pressure error threshold value can be determined based on starting pressure as seen in [0047]. Furthermore, Gottlib teaches the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Figs. 3a and 4 and [0039]-[0040]). Therefore, the pressure error threshold value is an offset from a measurement parameter that is also dependent on a first plurality of measurements).
Regarding claim 46, Brand in view of Gottlib teaches the apparatus of claim 44, and Brand further teaches wherein after taking the one or more further measurements of the first parameter, the controller is further configured to update the measurement parameter, the updated measurement parameter being dependent on at least the one or more further measurements of the first parameter (Brand teaches parameter module 30 to determine one or more parameters based on the output signals of sensors 18 (see [0022] and [0028]) and further teaches control module 34 to maintain pressure due to parameter information determined by parameter module 30 (see [0042]). As such, the parameter information needs to be updated dependent on at least one or more further output signals/measurements of the sensor to maintain pressure).
Regarding claim 47, Brand in view of Gottlib teaches the apparatus of claim 46, and further teaches wherein the controller is further configured to set the updated fault boundary to be offset from the updated measurement parameter (Brand teaches parameter module 30 to determine one or more parameters based on the output signals of sensors 18 (see [0022] and [0028]) and further teaches control module 34 to maintain pressure due to parameter information determined by parameter module 30 (see [0042]). Furthermore, Brand also teaches adjusting the first negative pressure level based on the output signals as seen in in Fig. 4 and [0037] and [0049]. As such, Brand in view of Gottlib teaches the parameters to be updated based on at least one or more further output signals/measurements of the sensor to maintain pressure and therefore the negative pressure level and pressure error threshold value will also be updated (as the negative pressure level is adjusted due to the output signals and parameter module 30)).
Regarding claim 52, Brand in view of Gottlib teaches the apparatus of claim 43, and Gottlib further teaches wherein the controller is further configured to determine the fault with the operation of the breathing system in response to the measurement being outside of the fault boundary or the updated fault boundary (Gottlib teaches the fault detection system 46 to determine a fault if the measured pressure is greater than the pressure error threshold as seen in Figs. 3a and 4 and [0036] and [0039]-[0040]).
Regarding claim 53, Brand in view of Gottlib teaches the apparatus of claim 52, and Brand further teaches wherein back pressure is a difference between pressure at any point within the breathing system and an ambient pressure and the patient pressure is another pressure at or in proximity of a patient interface of the breathing system (see claim 43 above where the first parameter is indicative of flow rate and pressure but not back pressure; Brand teaches one or more sensors 18 can be located within interface application 26 to measure pressure as seen in [0022], and therefore measures patient pressure in proximity of the interface application 26 as seen in Fig. 1).
Regarding claim 54, Brand in view of Gottlib teaches the apparatus of claim 43, and further teaches wherein the one or more of the at least one sensor or the controller are configured to repeat the update procedure at least once (Brand teaches method 400 is used to enhanced secretion removal from an airway of a subject using processor 22 as seen in Fig. 4 and [0045]-[0046] and [0050], wherein the processor operation can be repeated), wherein the fault boundary being updated in each subsequent update procedure is the updated fault boundary from a previous update procedure (Brand teaches parameter module 30 to determine one or more parameters based on the output signals of sensors 18 (see [0022] and [0028]) and further teaches control module 34 to maintain pressure due to parameter information determined by parameter module 30 (see [0042]). Furthermore, Brand also teaches adjusting the first negative pressure level based on the output signals as seen in in Fig. 4 and [0037] and [0049]. As such, Brand in view of Gottlib teaches the pressure error threshold value to be updated (as the negative pressure level is adjusted) in each subsequent update (as the pressure error threshold value is the allowed difference from the target pressure/negative pressure level)).
Regarding claim 56, Brand in view of Gottlib teaches the apparatus of claim 43, and Brand further teaches wherein the at least one sensor is further configured to take the series of measurements of the first parameter during operation of the breathing system (Brand teaches one or more sensors 18 to convey one or more output signals conveying information related to one or more parameters of the pressurized flow of breathable gas as seen in [0022]. Brand further teaches method 400 with operation 402 wherein a pressurized flow of breathable gas is generated before operation 404 of generating outputting signals conveying information related to gas parameters as seen in Fig. 4 and [0047]), or the controller is further configured to set the fault boundary for the first parameter during operation of the breathing system.
Regarding claim 57, Brand in view of Gottlib teaches the apparatus of claim 43, and Brand further teaches wherein the respiratory apparatus is further configured to commence supplying the gas to the breathing system before the at least one sensor takes the series of measurements of the first parameter (Brand teaches method 400 with operation 402 wherein a pressurized flow of breathable gas is generated before operation 404 of generating outputting signals conveying information related to gas parameters as seen in Fig. 4 and [0047]).
Regarding claim 58, Brand in view of Gottlib teaches the apparatus of claim 43, and Brand further teaches a breathing system (conduit 24 and interface applicant 26, see Fig. 1) in fluid communication with the respiratory apparatus (pressure generator 14, sensor 18 and processor 22, see Fig. 1) (see Fig. 1 and [0021]), the breathing system comprising a patient interface (interface appliance 26, see Fig. 1) arranged to supply the gas to a patient (subject 12, see Fig. 1) in use (see Fig. 1 and [0021]), and a breathing tube (conduit 24, see Fig. 1) arranged to deliver the gas supply from the respiratory apparatus to the patient interface (see [0021]).
Regarding claim 59, Brand teaches a method of monitoring a breathing system (Brand teaches method 400 which comprises using sensors 18 to output signals conveying information related to gas parameters as seen in Figs. 1 and 4 and [0022] and [0047]), the method comprising:
taking a series of measurements of a first parameter of the breathing system after a gas is first supplied to the breathing system (Brand teaches one or more sensors 18 to convey one or more output signals conveying information related to one or more parameters of the pressurized flow of breathable gas as seen in [0022]. Brand further teaches method 400 with at operation 402 a pressurized flow of breathable gas is generated before operation 404 of generating outputting signals conveying information related to gas parameters as seen in Fig. 4 and [0047]), wherein the first parameter comprises or is indicative of flow rate, back pressure within the breathing system, or patient pressure (Brand teaches sensors 18 to output signals indicative of one or more of a flow rate or a pressure as seen in [0022]); and
setting a level for the first parameter, the level being dependent on a plurality of the series of measurements of the first parameter (Brand teaches parameter module 30 to determine one or more parameters based on the output signals of sensors 18 and further teaches the pressure generator is controlled to provide the pressurized flow of breathable gas at a first negative pressure level based on the output signals as seen in [0028], [0037] and [0048]. As such, Brand teaches setting the negative pressure level based on the one or more parameters based on the output signals), wherein the method further includes at least one update procedure comprising the steps of:
taking one or more further measurements of the first parameter; and
updating the fault level, the updated fault level being dependent on an updated set of measurements of the first parameter, the updated set of measurements of the first parameter including at least one of the one or more further measurements of the first parameter (Brand teaches the sensors 18 generating output signals in operation 404 and further teaches operation 408 wherein the first negative pressure level is adjusted with the titration module based on the output signals (and as such the updated/adjusted negative pressure level depends on updated measurements/output signals) as seen in Fig. 4 and [0037] and [0049]. As such, sensors 18 will be generating further measurements/output signals to determine the parameter for the parameter module 30)
But does not teach setting a fault boundary for the first parameter, the fault boundary being dependent on a plurality of the series of measurements of the first parameter, wherein the method further includes at least one update procedure comprising the steps of:
taking one or more further measurements of the first parameter; and
updating the fault boundary, the updated fault boundary being dependent on an updated set of measurements of the first parameter, the updated set of measurements of the first parameter including at least one of the one or more further measurements of the first parameter;
automatically determining whether there is a fault with an operation of the breathing system based on a comparison of a measurement of the first parameter with the fault boundary or the updated fault boundary; and
in response to determining the fault, outputting an indication of the fault.
However, Gottlib teaches setting a fault boundary for the first parameter (Gottlib teaches pressure detector 42 to detect a pressure of gas as seen in [0023], wherein the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Fig. 3a and [0039]), the fault boundary being dependent on a plurality of the series of measurements of the first parameter (Gottlib teaches the pressure error threshold value can be determined based on starting pressure as seen in [0047], and therefore is dependent on a first plurality of measurements)
automatically determining whether there is a fault with an operation of the breathing system based on a comparison of a measurement of the first parameter with the fault boundary or the updated fault boundary (Gottlib teaches fault detection system 46 wherein the measured pressured is subtracted from a target pressure through a subtractor 60a giving a pressure error value as seen in Fig. 3a and [0039]. The pressure error value is then sent through a filter 62a before being compared to a pressure error threshold value to indicate whether or not a fault condition has been detected as seen in Fig. 3a and [0040]); and
in response to determining the fault, outputting an indication of the fault (Gottlib teaches generating an alert detectable by a human when the fault detection system 46 detects that a fault condition exists as seen in Fig.4 and [0026], [0044] and [0060]).
Brand teaches a negative pressure level based on the output of signals as seen in [0028], [0037] and [0048]. Gottlib teaches wherein the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Fig. 3a and [0039]-[0040]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Brand to include the fault detection system as taught by Gottlib to detect operational faults that can lead to injury or cause mechanical stresses within the breathing device (see [0003]).
Regarding claim 60, Brand teaches a method of monitoring a breathing system (Brand teaches method 400 which comprises using sensors 18 to output signals conveying information related to gas parameters as seen in Figs. 1 and 4 and [0022] and [0047]), the method comprising:
supplying a gas to the breathing system (Brand teaches a pressurized flow of breathable gas for delivery to the airway of the subject is generated with the pressure generator for operation 402 in method 400 as seen in Figs. 1 and 4 and [0021] and [0047]);
taking a series of measurements of a first parameter of the breathing system after the gas is first supplied to the breathing system (Brand teaches one or more sensors 18 to convey one or more output signals conveying information related to one or more parameters of flow rate (taken as first parameter) of the pressurized flow of breathable gas as seen in [0022]. Brand further teaches method 400 with at operation 402 a pressurized flow of breathable gas is generated before operation 404 of generating outputting signals conveying information related to gas parameters as seen in Fig. 4 and [0047]), wherein the first parameter comprises or is indicative of flow rate, back pressure within the breathing system, or patient pressure (Brand teaches sensors 18 to output signals indicative of one or more of a flow rate or a pressure as seen in [0022]);
setting a fault level for the first parameter, the fault level being dependent on a plurality of the series of measurements of the first parameter (Brand teaches parameter module 30 to determine one or more parameters based on the output signals of sensors 18 and further teaches the pressure generator is controlled to provide the pressurized flow of breathable gas at a first negative pressure level based on the output signals as seen in [0028], [0037] and [0048]. As such, Brand teaches setting the negative pressure level based on the one or more parameters based on the output signals);
controlling a second parameter of the breathing system during the supply of the gas to the breathing system (Brand teaches the pressure generator 14 can control one or more parameters of the pressurized flow including pressure (taken as second parameter) and flow rate as seen in [0019] and [0022]), wherein the first parameter of the breathing system is dependent on the second parameter and the breathing system (the flow rate of the breathable gas is dependent on the pressure level set by from the pressure generator 14 as seen in [0019]-[0020])
but does not teach setting a fault boundary for the first parameter, the fault boundary being dependent on a plurality of the series of measurements of the first parameter;
automatically determining whether there is a fault with an operation of the breathing system based on a change in the first parameter; and
in response to determining the fault, outputting an indication of the fault.
However, Gottlib teaches setting a fault boundary for the first parameter (Gottlib teaches pressure detector 42 to detect a pressure of gas as seen in [0023], wherein the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Fig. 3a and [0039]), the fault boundary being dependent on a plurality of the series of measurements of the first parameter (Gottlib teaches the pressure error threshold value can be determined based on starting pressure as seen in [0047], and therefore is dependent on a first plurality of measurements);
automatically determining whether there is a fault with an operation of the breathing system based on a change in the first parameter (Gottlib teaches fault detection system 46 wherein the measured pressured is subtracted from a target pressure through a subtractor 60a giving a pressure error value as seen in Fig. 3a and [0039]. The pressure error value is then sent through a filter 62a before being compared to a pressure error threshold value to indicate whether or not a fault condition has been detected as seen in Fig. 3a and [0040]); and
in response to determining the fault, outputting an indication of the fault (Gottlib teaches generating an alert detectable by a human when the fault detection system 46 detects that a fault condition exists as seen in Fig.4 and [0026], [0044] and [0060]).
Brand teaches a negative pressure level based on the output of signals as seen in [0028], [0037] and [0048]. Gottlib teaches wherein the measured pressure is compared with a target pressure and the difference is a pressure error value that is compared to a pressure error threshold value (taken as fault boundary) as seen in Fig. 3a and [0039]-[0040]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Brand to include the fault detection system as taught by Gottlib to detect operational faults that can lead to injury or cause mechanical stresses within the breathing device (see [0003]).
Regarding claim 61, Brand in view of Gottlib teaches the method of claim 60, and further teaches wherein the second parameter is flow rate or pressure within the breathing system (Brand teaches the pressure generator 14 can control one or more parameters of the pressurized flow including pressure (taken as second parameter) and flow rate as seen in [0019] and [0022]).
Regarding claim 62, Brand in view of Gottlib teaches the method of claim 60, and Brand further teaches wherein the back pressure is a difference between pressure at any point within the breathing system and an ambient pressure and the patient pressure is another pressure at or in proximity of a patient interface of the breathing system (see claim 60 above where the first parameter is indicative of flow rate and pressure but not back pressure; Brand teaches one or more sensors 18 can be located within interface application 26 to measure pressure as seen in [0022], and therefore measures patient pressure in proximity of the interface application 26 as seen in Fig. 1).
Claim(s) 45 and 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brand (US 20160287823 A1) in view of Gottlib (US 20080053441 A1) as applied to claim 44/47 above, and further in view of Bonomi (US 20200273584 A1).
Regarding claim 45, Brand in view of Gottlib teaches the apparatus of claim 44, but does not teach wherein the offset of the fault boundary from the measurement parameter is a predetermined amount or an amount that is dependent on a variance factor of one or more of the first plurality of the series of measurements of the first parameter, the second plurality of the series of measurements of the first parameter, or a third plurality of the series of measurements of the first parameter.
However, Bonomi teaches wherein the offset of the fault boundary from the measurement parameter is a predetermined amount or an amount that is dependent on a variance factor of a series of measurements (Bonomi teaches using the center points of measurements in which an offset is added/subtracted to determine the upper trend line and lower trend line, wherein the offset is estimated from the variance as seen in [0084]).
Bonomi teaches an apparatus 20 comprising a control unit 22 to implement the monitoring method, wherein the control unit 22 is configured to process a time series of measurements of a physiological characteristic for a subject as seen in [0057]. Apparatus 20 further teaches a physiological characteristic sensor 36 that is for measuring one or more physiological characteristics of a subject as seen in [0059]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brand in view of Gottlib to include the control unit to have the offset be estimated from the variance as taught by Bonomi as a known way to calculate/set the offset that is to be added/subtracted from a central point of measurement/central tendency and to assure that the trend lines/thresholds are still adapted to the maximum/minimum values (see [0084]). Modified Brand teaches wherein the offset of the fault boundary from the measurement parameter is a predetermined amount or an amount that is dependent on a variance factor of one or more of the first plurality of the series of measurements of the first parameter, the second plurality of the series of measurements of the first parameter, or a third plurality of the series of measurements of the first parameter (modified Brand teaches using the center points of measurements in which an offset is added/subtracted to determine the upper trend line and lower trend line, wherein the offset is estimated from the variance as seen in [0084] of Bonomi, wherein the measurements are the first plurality of series of measurements of the first parameter taught by Brand).
Regarding claim 48, Brand in view of Gottlib teaches the apparatus of claim 47, but does not teach wherein the offset of the fault boundary from the measurement parameter is a first amount that is dependent on a variance factor of one or more of the first plurality of the series of measurements of the first parameter, the second plurality of the series of measurements of the first parameter, or a third plurality of the series of measurements of the first parameter, and after the one or more further measurements of the first parameter are taken, the controller is further configured to update the variance factor, the updated variance factor being dependent on the updated set of measurements of the first parameter, and the offset of the updated fault boundary from the updated measurement parameter is a second amount that is dependent on the updated variance factor.
However, Bonomi teaches wherein the offset of the fault boundary from the measurement parameter is an amount that is dependent on a variance factor of a plurality of the measurements (Bonomi teaches using the center points of measurements in which an offset is added/subtracted to determine the upper trend line and lower trend line, wherein the offset is estimated from the variance as seen in [0084]).
Bonomi teaches an apparatus 20 comprising a control unit 22 to implement the monitoring method, wherein the control unit 22 is configured to process a time series of measurements of a physiological characteristic for a subject as seen in [0057]. Apparatus 20 further teaches a physiological characteristic sensor 36 that is for measuring one or more physiological characteristics of a subject as seen in [0059]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brand in view of Gottlib to include the control unit to have the offset be estimated from the variance as taught by Bonomi as a known way to calculate/set the offset that is to be added/subtracted from a central point of measurement/central tendency and to assure that the trend lines/thresholds are still adapted to the maximum/minimum values (see [0084]). Modified Brand teaches wherein the offset of the fault boundary from the measurement parameter is a first amount that is dependent on a variance factor of one or more of the first plurality of the series of measurements of the first parameter, the second plurality of the series of measurements of the first parameter, or a third plurality of the series of measurements of the first parameter (modified Brand teaches using the center points of measurements in which an offset is added/subtracted to determine the upper trend line and lower trend line, wherein the offset is estimated from the variance as seen in [0084] of Bonomi, wherein the measurements are the first plurality of series of measurements of the first parameter taught by Brand), and after the one or more further measurements of the first parameter are taken, the controller is further configured to update the variance factor, the updated variance factor being dependent on the updated set of measurements of the first parameter, and the offset of the updated fault boundary from the updated measurement parameter is a second amount that is dependent on the updated variance factor (modified Brand teaches after taking outputting further signals of the first parameter, updating the variance due to the new set of measurements (see [0084 of Bonomi) and the offset of the updated pressor error threshold value from the updated measurement parameter is also updated base on the variance. As such, the offset based off the variance (taught by Bonomi) is also to be updated based on the new measurements to assure that the trend lines/thresholds are still adapted to the maximum/minimum values as seen in [0084] of Bonomi).
Regarding claim 49, modified Pittman teaches the apparatus of claim 48, and further teaches wherein the updated variance factor is dependent on at least one of the one or more further measurements of the first parameter (modified Brand teaches after taking outputting further signals of the first parameter, updating the variance due to the new set of measurements (see [0084 of Bonomi). As such, the updated variance is dependent on at least one of the one or more further measurements).
Claim(s) 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brand (US 20160287823 A1) in view of Gottlib (US 20080053441 A1) as applied to claim 43/46 above, and further in view of Consentino (US 20060064030 A1).
Regarding claim 50, Brand in view of Gottlib teaches the apparatus of claim 46, but does not teach wherein the measurement parameter is an average of one or more first, second or third plurality of the series of measurements or the updated measurement parameter is an average of the one or more further measurements of the first parameter
However, Consentino teaches wherein the measurement parameter is an average of one or more first, second or third plurality of the series of measurements or the updated measurement parameter is an average of the one or more further measurements of the first parameter (Consentino teaches a patient monitoring device 3800 to obtain information regarding a physiological parameter (see [0226]), and further teaches software to be find a central tendency of measurements, wherein, the central tendency can be the average value over a series of measurements of the parameter as seen in [0239] and [0201]. Additionally, the central tendency is updated based on the updated time period of measurements as seen in Figs. 39A-39B and [0236]-[0237]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brand in view of Gottlib to include the microprocessor system as taught by Consentino to use an average of measurements for a parameter as a known method of representing datapoints (see [0239]).
Regarding claim 51, Brand in view of Gottlib teaches the apparatus of claim 43, but does not teach wherein the updated set of measurements comprises at least one of the measurements upon which the fault boundary being updated is dependent and at least one of the one or more further measurements, and wherein the at least one of the one or more further measurements replaces an equivalent number of one or more earliest measurements upon which the fault boundary being updated is dependent.
However, Consentino teaches wherein the updated set of measurements comprises at least one of the measurements upon which the fault boundary being updated is dependent and at least one of the one or more further measurements (Consentino teaches the software to re-establish a new threshold as seen in [0236], wherein the software is to find a central tendency over a time period and an offset variable may be added/subtracted to the central tendency as seen in [0239]. Wherein, the central tendency can be the average value over a series of measurements of the parameter as seen in [0239] and the updated/new threshold is based on the average value over the new set of measurements as seen in Fig. 39B and [0234] and [0236]-[0238]) and wherein the at least one of the one or more further measurements replaces an equivalent number of one or more earliest measurements upon which the fault boundary being updated is dependent (Consentino teaches the software to re-establish a new threshold as seen in [0236], wherein the software is to find a central tendency over a time period and an offset variable may be added/subtracted to the central tendency as seen in [0239]. Wherein, the central tendency can be the average value over a series of measurements of the parameter as seen in [0239] and the updated/new threshold is based on the average value over the new set of measurements as seen in Fig. 39B and [0234] and [0236]-[0238]. Therefore, the software can choose a time period one measurement after the previous one has ended to replace an equivalent number of the earliest measurements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brand in view of Gottlib to include the microprocessor system as taught by Consentino to use an average of measurements within a time period for a parameter as a known method of representing datapoints (see [0239]).
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brand (US 20160287823 A1) in view of Gottlib (US 20080053441 A1) as applied to claim 54 above, and further in view of Gavriely (US 20120215126 A1).
Regarding claim 55, Brand in view of Gottlib teaches the apparatus of claim 54, but does not teach wherein the one or more of the at least one sensor or the controller are configured to repeat the update procedure at intervals during operation of the breathing system, including at least a period during which the gas is supplied to the breathing system, or another period during which treatment is being provided to a patient, wherein at least one of the intervals is less than 10 seconds.
However, Gavriely teaches “…collected sound recordings from transducers T1 and T2 can be analysed discretely by processor 205 providing updates on the subject's condition at regular intervals (e.g. 1-10 seconds) over a period of time (see [0042]).”
Gavriely teaches a system determining a broncho-dynamic response of a subject 200 comprising interface to a subject as seen in [0039] and further teaches the subject interface to have provisions for oxygen delivery into the subject’s airway (see [0040] and [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brand in view of Gottlib to have the processor provide updates on the subject conditions at regular intervals of 1-10 seconds as taught by Gavriely. Modified Brand teaches wherein the one or more of the at least one sensor or the controller are configured to repeat the update procedure at intervals during operation of the breathing system (Modified Brand teaches updating the thresholds (as Brand teaches updating the first pressure negative level which then updates the pressure error threshold values taught by Gottlib) at intervals (taught by Gavriely) during operation of the breathing system, as Brand teaches sensors 18 to output signals conveying information regarding one or more parameters of the pressurized flow of breathable gas as system 10 is operating as seen in Fig. 1 and [0022]), including at least a period during which the gas is supplied to the breathing system, or another period during which treatment is being provided to a patient, wherein at least one of the intervals is 1-10 seconds (Brand teaches a pressurized flow of breathable gas for delivery to the airway of the subject is generated with the pressure generator for operation 402 in method 400 as seen in Figs. 1 and 4 and [0021] and [0047]. Modified Brand teaches analyzing a period which gas is supplied to the breathing in an interval from 1-10 seconds (see [0042] of Gavriely).
However, modified Brand does not explicitly disclose the intervals being less than 10 seconds.
It would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to modify the interval of modified Brand from 1-10 seconds to between 1-9.5 seconds as applicant appears to have placed no criticality on the claimed range (see page 9, lines 21-27, indicating the interval is “may be less than”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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