DETAILED ACTION
This office action is in response to application filed on September 3, 2024.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/03/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Preliminary amendments filed on November 18, 2024 have been entered.
Claims 1-18 have been added.
Claims 1-18 have been examined.
Specification
The disclosure is objected to because multiple informalities have been found throughout the specification (e.g., see below). Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Paragraphs [0004], [0028], [0066], [0074], [0076], [0101], [0109], [0110], [0112], [0113], [0120], [0131], [0142], [0166], [0168], [0171] appear to break between words.
Equations in paragraphs [0077], [0079], [0081], [0084], [0133], [0164] are not correctly illustrated.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim language “analyze the plurality of features with time and magnitude thresholds;” should read “analyze the plurality of features with a time threshold and a magnitude threshold; and” in order to provide appropriate antecedence basis and correct for minor informalities.
Appropriate correction is required.
Claim 2 is objected to because of the following informalities:
Claim language “The apparatus of claim 1 wherein the plurality of features comprises first and second features, and wherein the analysis comprises a comparison of the first feature to detect a change in the first feature existing for a pre-determined period of time attributable to the time threshold” should read “The apparatus of claim 1, wherein the plurality of features comprises a first feature and a second feature, and wherein the analysis comprises a comparison of the first feature with the time threshold to detect a change in the first feature existing for a pre-determined period of time .
Appropriate correction is required.
Claim 6 is objected to because of the following informalities:
Claim language should read “The apparatus of claim 5, wherein the leak indicator is set to represent [[a]]the continuous mouth leak if the comparison detects that the second feature falls below the magnitude threshold” in order to provide appropriate antecedence basis and clarify the recited subject matter for compliance under 35 U.S.C. 112.
Appropriate correction is required.
Claim 7 is objected to because of the following informalities:
Claim language should read “The apparatus of claim 5, wherein the first feature and the second feature are derived from a measure of ventilation and a measure of instantaneous leak” in order to provide appropriate antecedence basis and clarify the recited subject matter for compliance under 35 U.S.C. 112.
Appropriate correction is required.
Claim 10 is objected to because of the following informalities:
Claim language “A leak detection method for a respiratory treatment apparatus, the method comprising …” should read “A leak detection method for a respiratory treatment apparatus, the leak detection method comprising …” in order to provide appropriate antecedence basis.
Claim language “analyzing in a processor the plurality of features with time and magnitude thresholds” should read “analyzing in a processor the plurality of features with a time threshold and a magnitude threshold” in order to provide appropriate antecedence basis.
Appropriate correction is required.
Claim 11 is objected to because of the following informalities:
Claim language “The method of claim 10 wherein the plurality of features comprises first and second features, and wherein the analysis comprises a comparison of the first feature to detect a change in the first feature existing for a pre-determined period of time attributable to the time threshold” should read “The leak detection method of claim 10, wherein the plurality of features comprises a first feature and a second feature, and wherein the analysis comprises a comparison of the first feature with the time threshold to detect a change in the first feature existing for a pre-determined period of time .
Appropriate correction is required.
Claim 12 is objected to because of the following informalities:
Claim language “The method of claim …” should read “The leak detection method of claim …” in order to provide appropriate antecedence basis.
Appropriate correction is required.
Claim 13 is objected to because of the following informalities:
Claim language “The method of claim …” should read “The leak detection method of claim …” in order to provide appropriate antecedence basis.
Appropriate correction is required.
Claim 14 is objected to because of the following informalities:
Claim language “The method of claim …” should read “The leak detection method of claim …” in order to provide appropriate antecedence basis.
Appropriate correction is required.
Claim 15 is objected to because of the following informalities:
Claim language should read “The leak detection method of claim 14, wherein the leak indicator is set to represent [[a]]the continuous mouth leak if the comparison detects that the second feature falls below the magnitude threshold” in order to provide appropriate antecedence basis and clarify the recited subject matter for compliance under 35 U.S.C. 112.
Appropriate correction is required.
Claim 16 is objected to because of the following informalities:
Claim language should read “The leak detection method of claim 14, wherein the first feature and the second feature are derived from a measure of ventilation and a measure of instantaneous leak” in order to provide appropriate antecedence and clarify the recited subject matter for compliance under 35 U.S.C. 112.
Appropriate correction is required.
Claim 17 is objected to because of the following informalities:
Claim language should read “The leak detection method of claim 10, wherein the respiratory treatment apparatus comprises: a flow sensor, wherein the processor is further configured to determine the measured flow of breathable gas with the flow sensor; and a flow generator configured to produce a breathable gas for a patient at a pressure above atmospheric pressure, wherein the processor is further configured to control the flow generator to produce the breathable gas according to a pressure therapy regime” in order to provide appropriate antecedence and clarify the recited subject matter for compliance under 35 U.S.C. 112.
Appropriate correction is required.
Claim 18 is objected to because of the following informalities:
Claim language should read “The leak detection method of claim 17, wherein the processor controls the flow generator to produce the breathable gas according to the pressure therapy regime based on the leak indicator” in order to provide appropriate antecedence and clarify the recited subject matter for compliance under 35 U.S.C. 112.
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 1-8 and 10-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Regarding claim 1, the examiner submits that under Step 1 of the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (see also 2019 Revised Patent Subject Matter Eligibility Guidance) for evaluating claims for eligibility under 35 U.S.C. 101, the claim is to a machine, which is one of the statutory categories of invention.
Continuing with the analysis, under Step 2A - Prong One of the test:
the limitation “determine a plurality of features from the measured flow of breathable gas” is a process that, under its broadest reasonable interpretation in light of the specification, covers performance of the limitation using mathematical concepts to obtain additional data (i.e., plurality of features; see specification at [0021]-[0022], [0030], [0032], [0034], [0074]). Except for the recitation of the extra-solution activities (e.g., source/type of data being evaluated), the limitation in the context of the claim mainly refers to applying mathematical concepts to manipulate data and obtain additional information.
the limitation “analyze the plurality of features with time and magnitude thresholds” is a process that, under its broadest reasonable interpretation in light of the specification, covers performance of the limitation using mathematical concepts to compare data (see specification at [0023], [0030]-[0031], [0075]-[0076], [0083]-[0087], [0094], [0134]). Except for the recitation of the extra-solution activities (e.g., source/type of data being evaluated), the limitation in the context of the claim mainly refers to applying mathematical concepts to compare data against thresholds.
the limitation “based on the analysis, set a leak indicator, the leak indicator representative of a continuous mouth leak” is a process that, under its broadest reasonable interpretation and in light of the specification, covers performance of the limitation using mental processes and/or mathematical concepts (see specification at [0031]-[0032], [0139]). Except for the recitation of the extra-solution activities (e.g., source/type of data being evaluated), the limitation in the context of the claim mainly refers to performing a mental evaluation and/or applying mathematical concepts to set a flag.
Therefore, the claim recites a judicial exception under Step 2A - Prong One of the test.
Furthermore, under Step 2A - Prong Two of the test, this judicial exception is not integrated into a practical application when considering the claim as a whole. In particular, the additional elements recited in the claim:
“A leak detection apparatus” generally link the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)); and
“a controller having at least one processor to access data representing a measured flow of breathable gas” merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) while also adding extra-solution activities (e.g., mere data gathering, source/type of data to be manipulated) (see MPEP 2106.05(g)).
Accordingly, these additional elements, when considered individually and in combination, do not integrate the judicial exception into a practical application because they do not impose any meaningful limits on practicing the abstract idea when considering the claim as a whole. The claim is directed to a judicial exception under Step 2A of the test.
Additionally, under Step 2B of the test, the claim, when considered as a whole, does not include additional elements that, when considered individually and in combination, are sufficient to amount to significantly more than the judicial exception because the additional elements:
generally link the use of the judicial exception to a particular technological environment or field of use (i.e., leak detection), which as indicated in the MPEP: “As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible “simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use.” Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself” (see MPEP 2106.05(h));
recite extra-solution activities (i.e., mere data gathering by selecting a particular data source/type to be manipulated), which as indicated in the MPEP: “Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term “extra-solution activity” can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process” (see MPEP 2106.05(g)); and
append generic computer components (i.e., a controller having at least one processor) used to facilitate the application of the abstract idea (i.e., mere computer implementation), which as indicated in the MPEP: “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more” (see MPEP 2106.05(f), item 2).
The claim, when considered as a whole, does not provide significantly more under Step 2B of the test.
Based on the analysis, the claim is not patent eligible.
Similarly, independent claim 10 is directed to a judicial exception (abstract idea) without significantly more as explained above with regards to claim 1.
With regards to the dependent claims, they are also directed to the non-statutory subject matter because:
they just extend the abstract idea of the independent claims by additional limitations (Claims 2-7 and 11-16), that under the broadest reasonable interpretation, cover performance of the limitations using mental processes and/or mathematical concepts, and
the additional elements, when considered individually and in combination, recited in the dependent claims refer to refer to extra-solution activities (e.g., mere data gathering using a data type or source), generic computer components and/or field of use (Claims 8 and 17), which as indicated in the Office’s guidance does not integrate the judicial exception into a practical application (Step 2A – Prong Two) and/or does not provide significantly more (Step 2B) when considering the claimed invention as a whole.
Examiner’s Note
Claims 9 and 18 were evaluated for patent eligibility under 35 U.S.C. 101 using the SUBJECT MATTER ELIGIBILITY TEST FOR PRODUCTS AND PROCESSES described in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (see also 2019 Revised Patent Subject Matter Eligibility Guidance) to determine patent eligibility under 35 U.S.C. 101.
Regarding claim 9, the examiner submits that under Step 1 of the test for evaluating claims for eligibility under 35 U.S.C. 101, the claim is to a machine, which is one of the statutory categories of invention.
Continuing with the analysis, under Step 2A - Prong One of the test, the examiner submits that claim 9 recites a judicial exception (i.e., abstract idea) as indicated above with respect to claim 1. Therefore, the claim recites a judicial exception under Step 2A - Prong One of the test.
Furthermore, under Step 2A - Prong Two of the test, the examiner submits that claim 9 recites the additional elements of claim 1 and “the controller is further configured to control the flow generator to produce the breathable gas according to the pressure therapy regime based on the leak indicator”, which when considering the claim as a whole, integrates the judicial exception into a practical application by effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)).
Therefore, these additional elements, when considered individually and in combination, integrate the judicial exception into a practical application. The claim, when considered as a whole, is eligible at Prong Two of the Revised Step 2A (see 2019 Revised Patent Subject Matter Eligibility Guidance – Revised Step 2A, see also MPEP 2106.04(d)).
Similar analysis applies to claim 18, which also becomes eligible under Step 2A - Prong Two of the test.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 34-43 of U.S. Patent No. 10328219. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the U.S. Patent anticipate the claims in the current application (see table for comparison wherein the bold text in the claims in the U.S. Patent anticipates the claimed subject matter in the current application; the examiner notes that claim 34 of the U.S. Patent depends from claim 32, which depends from claim 28, which depends from claim 27, which depends from claim 17; see also current application at [0022] and claim 7 regarding plurality of features including measure of ventilation and measure of instantaneous leak, and U.S. Patent claims 6 and 23 regarding the leak measure comprising an instantaneous leak).
Application 18/822737
US 10328219 B2
Claim 1.
A leak detection apparatus comprising:
a controller having at least one processor to access data representing a measured flow of breathable gas, the controller being configured to:
determine a plurality of features from the measured flow of breathable gas;
analyze the plurality of features with time and magnitude thresholds;
based on the analysis, set a leak indicator, the leak indicator representative of a continuous mouth leak.
Claim 17.
A leak detection apparatus comprising:
a controller having at least one processor to access data representing a measured flow of breathable gas measured with a sensor, the flow of breathable gas provided with a respiratory pressure treatment apparatus, the controller being further configured to:
determine a ventilation measure and a leak measure from the measured flow;
analyze a covariance signal from the ventilation measure and the leak measure to detect a contemporaneous change comprising a change in the ventilation measure contemporaneous with a change in the leak measure;
identify a continuous mouth leak event based on the contemporaneous change; and
control a respiratory therapy provided with the flow of breathable gas generated by the respiratory pressure treatment apparatus based on the covariance signal.
Claim 34.
The apparatus of claim 32, wherein the controller is further configured to access data representing a measured flow of breathable gas so as to:
determine a plurality of features from the ventilation measure and the leak measure;
analyze the plurality of features with a time threshold and a magnitude threshold; and
based on the analysis, set a leak indicator representative of the continuous mouth leak event.
Claim 2.
The apparatus of claim 1 wherein the plurality of features comprises first and second features, and wherein the analysis comprises a comparison of the first feature to detect a change in the first feature existing for a pre-determined period of time attributable to the time threshold; and wherein the analysis further comprises a comparison of the second feature with the magnitude threshold based on the comparison of the first feature detecting the change for the pre-determined period of time.
Claim 35.
The apparatus of claim 34 wherein the plurality of features comprise a first feature and a second feature, and wherein the analysis comprises evaluation of the first feature to detect a change in the first feature existing for a pre-determined period of time attributable to the time threshold; and wherein the analysis further comprises a comparison of the second feature with the magnitude threshold, based on the comparison of the first feature detecting the change for the pre-determined period of time.
Claim 3.
The apparatus of claim 2, wherein the first feature comprises a modified covariance signal.
Claim 5.
The apparatus of claim 3, wherein the second feature comprises a covariance sum.
Claim 36.
The apparatus of claim 35 wherein the first feature comprises a modified covariance signal and the second feature comprises a covariance sum.
Claim 1.
A leak detection apparatus comprising:
a controller having at least one processor to access data representing a measured flow of breathable gas, the controller being configured to:
determine a plurality of features from the measured flow of breathable gas;
analyze the plurality of features with time and magnitude thresholds;
based on the analysis, set a leak indicator, the leak indicator representative of a continuous mouth leak.
Claim 17.
A leak detection apparatus comprising:
a controller having at least one processor to access data representing a measured flow of breathable gas measured with a sensor, the flow of breathable gas provided with a respiratory pressure treatment apparatus, the controller being further configured to:
determine a ventilation measure and a leak measure from the measured flow;
analyze a covariance signal from the ventilation measure and the leak measure to detect a contemporaneous change comprising a change in the ventilation measure contemporaneous with a change in the leak measure;
identify a continuous mouth leak event based on the contemporaneous change; and
control a respiratory therapy provided with the flow of breathable gas generated by the respiratory pressure treatment apparatus based on the covariance signal.
Claim 37.
The leak detection apparatus of claim 17 wherein the controller is configured to:
determine a plurality of features from the determined ventilation measure and leak measure;
analyze the plurality of features with a time threshold and a magnitude threshold;
based on the analysis, set a leak indicator, the leak indicator representative of the continuous mouth leak event.
Claim 2.
The apparatus of claim 1 wherein the plurality of features comprises first and second features, and wherein the analysis comprises a comparison of the first feature to detect a change in the first feature existing for a pre-determined period of time attributable to the time threshold; and wherein the analysis further comprises a comparison of the second feature with the magnitude threshold based on the comparison of the first feature detecting the change for the pre-determined period of time.
Claim 38.
The apparatus of claim 37 wherein the plurality of features comprise first and second features, and wherein the analysis comprises evaluation of the first feature to detect a change in the first feature existing for a pre-determined period of time attributable to the time threshold; and wherein the analysis further comprises a comparison of the second feature with the magnitude threshold based on the comparison of the first feature detecting the change for the pre-determined period of time.
Claim 3.
The apparatus of claim 2, wherein the first feature comprises a modified covariance signal.
Claim 39.
The apparatus of claim 38 wherein the first feature comprises a modified covariance signal.
Claim 4.
The apparatus of claim 3, wherein the change in the first feature is negative.
Claim 40.
The apparatus of claim 39 wherein the change in the first feature is negative.
Claim 5.
The apparatus of claim 3, wherein the second feature comprises a covariance sum.
Claim 41.
The apparatus of claim 39 wherein the second feature comprises a covariance sum.
Claim 6.
The apparatus of claim 5, wherein the leak indicator is set to represent a continuous mouth leak if the comparison detects that the second feature falls below the threshold.
Claim 42.
The apparatus of claim 41 wherein the leak indicator is set to represent the continuous mouth leak event if the comparison detects that the second feature falls below the magnitude threshold.
Claim 7.
The apparatus of claim 5, wherein the first and second features are derived from a measure of ventilation and a measure of instantaneous leak.
Claim 43.
The apparatus of claim 41 wherein the first and second features are derived from the ventilation measure and the leak measure.
Claim 10.
A leak detection method for a respiratory treatment apparatus, the method comprising:
determining a plurality of features from a measured flow of breathable gas associated with a respiratory treatment apparatus;
analyzing in a processor the plurality of features with time and magnitude thresholds; and
based on the analysis, setting a leak indicator, the leak indicator representative of a continuous mouth leak.
Claim 1
A method for controlling a processor to detect leak from a flow of breathable gas within a respiratory pressure treatment apparatus, the method comprising:
measuring the flow using a sensor; and
in the processor:
determining a ventilation measure and a leak measure from the measured flow;
analyzing a covariance signal from the ventilation measure and the leak measure to detect a contemporaneous change comprising a change in the ventilation measure contemporaneous with a change in the leak measure;
identifying a continuous mouth leak event based on the contemporaneous change; and
controlling a respiratory therapy provided with the flow of breathable gas generated by the respiratory pressure treatment apparatus based on the covariance signal.
Claim 11.
The method of claim 1, the method further comprising:
determining a plurality of features from the ventilation measure and the leak measure;
analyzing in the processor the plurality of features with a time threshold and a magnitude threshold; and
based on the analysis, setting a leak indicator, the leak indicator representative of the continuous mouth leak event.
Subject Matter Not Rejected Over Prior Art
Claims 1-8 and 10-17 are distinguished over the prior art of record for the following reasons:
Regarding claim 1.
Jourdain (US 20110196251 A1, IDS reference) discloses:
A leak detection apparatus (Fig. 2, [0001], [0021]: estimation of leak flow in a breathing assistance system is presented) comprising:
a controller (Fig. 2, item 50 – ‘controller’) having at least one processor (Fig. 2, item 56 – ‘processor’, [0025]: controller is part of the breathing assistance system, and includes one or more processors) to access data representing a measured flow of breathable gas (Fig. 5, item 204, [0064]: controller records a flow vs. time waveform indicating flow of breathable gas between a ventilation device and a patient (see also [0013] and [0022])), the controller being configured to:
determine a plurality of features from the measured flow of breathable gas ([0033]: flow waveform is analyzed in order to identify an “end of exhalation phase” (Fig. 4, item 102), and further an “end exhalation steady phase - EESP phase” (Fig. 4, item 106));
analyze the plurality of features ([0033]: the controller performs linear regression on the EESP phase in order to calculate an “estimated end-of-exhalation leak flow” (Fig. 4, item 110) (see also [0032] regarding using thresholds for analysis of respiratory phases));
based on the analysis, set a leak indicator ([0033]: leak flow is used to calculate a leak factor).
Regarding “analyze the plurality of features with time and magnitude thresholds”, Douglas (US 20070215146 A1, IDS reference) discloses:
“In delivering pressure, the triggering module monitors the patient to make a determination of the patients respiratory phase in order to synchronise the blower output with the patient’s efforts. In one form, the determination is whether the patient is inhaling or exhaling (a discrete variable). In another form, the determination is of the proportion into the overall respiratory cycle of the patient (a periodic variable). Determination of phase may be made by some combination of pressure, flow and effort sensors. For example, in one form, when mask pressure drops below a threshold, the transition to inhalation is taken to have occurred and correspondingly when mask pressure rises above a threshold, the transition to exhalation is taken to have occurred. In another form, when patient respiratory flow exceeds a threshold, inhalation is taken to have started and when patient respiratory flow falls below a threshold, exhalation is taken to have started” ([0032]: thresholds are used for analysis of respiratory phases (see also [0033])).
Douglas (US 20070215146 A1, IDS reference) also discloses:
“In one form, the apparatus includes mouth leak detection apparatus, particularly useful for detection of mouth leak when a nasal mask is used ... Thus, the apparatus may include a module, such as a software module or process, that receives a signal indicative of total leak from the mask, as well as a signal indicating whether the patient is inhaling or exhaling. Additionally or alternatively, the software module receives a signal which includes markers indicating trigger and cycle time points. The mouth leak detection software module analyzes the total leak signal and determines whether or not there is a mouth leak, or that the mouth has opened resulting when leak increases coincident with exhalation ... Alternatively, as illustrated in FIG. 7, in the presence of leak, the EPAP pressure or end expiratory pressure may be reduced to reduce mouth leak or any other detected mask leak. In one form, the software module integrates the total leak flow during inhalation to calculate total inhalation leak volume. A similar calculation is made to determine total leak exhalation volume. If the leak exhalation volume is greater than the leak inhalation volume by a threshold value, then the software module determines that mouth leak is present or that the mouth is opening or open during exhalation” ([0063]: a mouth leak detection apparatus receives a total leak signal in order to determine whether or not there is a mouth leak and control the pressure delivered to a patient).
The closest prior art of record, taken individually or in combination, fail to teach or suggest:
“the leak indicator representative of a continuous mouth leak”
in combination with all other limitations within the claim, as claimed and defined by the applicant.
Regarding claim 8.
Jourdain (US 20110196251 A1, IDS reference) discloses:
A leak detection method (Fig. 5) for a respiratory treatment apparatus (Fig. 2, [0001], [0021]: estimation of leak flow in a breathing assistance system is presented), the method comprising:
determining a plurality of features from a measured flow of breathable gas associated with a respiratory treatment apparatus (Fig. 5, item 204, [0033], [0064]: controller records a flow vs. time waveform indicating flow of breathable gas between a ventilation device and a patient (see also [0013] and [0022]); flow waveform is analyzed in order to identify an “end of exhalation phase” (Fig. 4, item 102), and further an “end exhalation steady phase - EESP phase” (Fig. 4, item 106));
analyzing in a processor (Fig. 2, item 56 – ‘processor’, [0025]: controller is part of the breathing assistance system, and includes one or more processors) the plurality of features ([0033]: the controller performs linear regression on the EESP phase in order to calculate an “estimated end-of-exhalation leak flow” (Fig. 4, item 110)); and
based on the analysis, setting a leak indicator ([0033]: leak flow is used to calculate a leak factor).
Regarding “analyzing in a processor the plurality of features with time and magnitude thresholds”, Douglas (US 20070215146 A1, IDS reference) discloses:
“In delivering pressure, the triggering module monitors the patient to make a determination of the patients respiratory phase in order to synchronise the blower output with the patient’s efforts. In one form, the determination is whether the patient is inhaling or exhaling (a discrete variable). In another form, the determination is of the proportion into the overall respiratory cycle of the patient (a periodic variable). Determination of phase may be made by some combination of pressure, flow and effort sensors. For example, in one form, when mask pressure drops below a threshold, the transition to inhalation is taken to have occurred and correspondingly when mask pressure rises above a threshold, the transition to exhalation is taken to have occurred. In another form, when patient respiratory flow exceeds a threshold, inhalation is taken to have started and when patient respiratory flow falls below a threshold, exhalation is taken to have started” ([0032]: thresholds are used for analysis of respiratory phases (see also [0033])).
Douglas (US 20070215146 A1, IDS reference) also discloses:
“In one form, the apparatus includes mouth leak detection apparatus, particularly useful for detection of mouth leak when a nasal mask is used ... Thus, the apparatus may include a module, such as a software module or process, that receives a signal indicative of total leak from the mask, as well as a signal indicating whether the patient is inhaling or exhaling. Additionally or alternatively, the software module receives a signal which includes markers indicating trigger and cycle time points. The mouth leak detection software module analyzes the total leak signal and determines whether or not there is a mouth leak, or that the mouth has opened resulting when leak increases coincident with exhalation ... Alternatively, as illustrated in FIG. 7, in the presence of leak, the EPAP pressure or end expiratory pressure may be reduced to reduce mouth leak or any other detected mask leak. In one form, the software module integrates the total leak flow during inhalation to calculate total inhalation leak volume. A similar calculation is made to determine total leak exhalation volume. If the leak exhalation volume is greater than the leak inhalation volume by a threshold value, then the software module determines that mouth leak is present or that the mouth is opening or open during exhalation” ([0063]: a mouth leak detection apparatus receives a total leak signal in order to determine whether or not there is a mouth leak and control the pressure delivered to a patient).
The closest prior art of record, taken individually or in combination, fail to teach or suggest:
“the leak indicator representative of a continuous mouth leak”
in combination with all other limitations within the claim, as claimed and defined by the applicant.
Regarding claims 2-8 and 10-17.
They are also distinguished over the prior art of record due to their dependency.
Allowable Subject Matter
Claims 9 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ARMITSTEAD JEFFREY PETER et al., WO 2008138040 A1, AUTOMATED CONTROL FOR DETECTION OF FLOW LIMITATION
Reference discloses a respiratory flow limitation devices that determines flow limitation measure based on shape indices for detecting partial obstruction and ventilation duty cycle.
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/LINA CORDERO/Primary Examiner, Art Unit 2857
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