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
The amendments filed 02 FEBRUARY 2026 have been entered. Claims 1 – 16, and 18 - 20 are pending. Applicant’s amendments to the claims have overcome each and every rejection to the claims under 35 U.S.C. 112 previously applied in the office action dated 01 AUGUST 2025.
Information Disclosure Statement
The items on the IDS submitted 04/03/2024 are duplicate to that submitted on 3/16/2023, so they have been crossed out, as they have already been documented as considered on the IDS submitted on 3/16/2023. As described in the office action dated 01 AUGUST 2025, Applicant has submitted these documents in duplicate which should be avoided in the future, as this add unnecessary volume to the record.
Claim Objections
Claim 3 objected to because of the following informalities: the term “during paradoxical movement of the abdomen and thorax” is suggested to be revised to “during paradoxical movement of the abdomen and the thorax of the subject” for readability and consistency with Claim 1, from which this claim depends. 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 – 16 and 18 - 20 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.
Regarding Claim 1, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claims 19 and 20, the claims each recite an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 16 and 18 - 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 16 and 18 - 20 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 16 and 18 - 20 recites an abstract idea.
Specifically, Independent Claims 1, 19, and 20 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
A computer-implemented method for determining a respiratory flow of a subject from data from respiratory inductance plethysmography (RIP) signals obtained from the subject, the method comprising:
receiving by one or more processors data of a thoracic signal of a first RIP belt arranged proximate with a thorax of a subject;
receiving by one or more processors data of an abdomen signal of a second RIP belt arranged proximate with an abdomen of the subject; and
determining by one or more processors a respiratory flow of the subject based on the data of the thoracic signal and the data of the abdomen signal,
wherein determining the respiratory flow includes two or more calibrations performed by one or more processors, including:
performing by one or more processors a first calibration by applying a first calibration coefficient that relates an amplitude of a differential change in the thoracic signal to an amplitude of a differential change in the abdomen signal to obtain a determined respiratory flow,
and
performing by one or more processors a second calibration on the determined respiratory flow that corrects for a non-linearity in the determined respiratory flow.
Claim 19
A device for determining a respiratory flow from data from respiratory inductance plethysmography (RIP) signals, the device comprising:
a processor configured to
receive data of a thoracic signal of a first RIP belt arranged proximate with a thorax of a subject;
receive data of an abdomen signal of a second RIP belt arranged proximate with an abdomen of the subject; and
determine a respiratory flow of the subject based on the data of the thoracic signal and the data of the abdomen signal,
wherein in determining the respiratory flow, the processor is configured to perform at least two or more calibrations, including:
performing a first calibration by applying a first calibration coefficient that relates an amplitude of a differential change in the thoracic signal to an amplitude of a differential change in the abdomen signal to obtain a determined respiratory flow, and
performing a second calibration on the determined respiratory flow that corrects for a non-linearity in the determined respiratory flow.
Claim 20
A system comprising:
a plurality of respiratory inductance plethysmography (RIP) belts, including a thoracic RIP belt configured to obtain a thoracic signal and an abdomen RIP belt configured to obtain an abdomen signal; and
a processor configured to
receive data of the thoracic signal of the thoracic RIP belt arranged proximate with a thorax of a subject;
receive data of the abdomen signal of the abdomen RIP belt arranged proximate with an abdomen of the subject; and
determine a respiratory flow of the subject based on the data of the thoracic signal and the data of the abdomen signal,
wherein in determining the respiratory flow, the processor is configured to perform at least two or more calibrations, including:
performing a first calibration by applying a first calibration coefficient that relates an amplitude of a differential change in the thoracic signal to an amplitude of a differential change in the abdomen signal to obtain a determined respiratory flow, and
performing a second calibration on the determined respiratory flow that corrects for a non-linearity in the determined respiratory flow.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1, 19, and 20, these limitations include:
Observation and judgment of data of a thoracic signal of a first RIP belt arranged proximate with a thorax of a subject;
Observation and judgment of data of an abdomen signal of a second RIP belt arranged proximate with an abdomen of the subject
Observation and judgment of a respiratory flow of the subject based on the data of the thoracic signal and the data of the abdomen signal
Observation and judgment of two or more calibrations to Observe and judge the respiratory flow performed
Observation and judgment to evaluate a first calibration by evaluating a first calibration coefficient that relates an amplitude of a differential change in the thoracic signal to an amplitude of a differential change in the abdomen signal to obtain a determined respiratory flow
Observation and judgment to evaluate a second calibration on the determined respiratory flow that corrects for a non-linearity in the determined respiratory flow
Similarly, the Dependent Claims include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1, 19, and 20 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
determining one or more endotypes of an obstructive sleep apnea or of another sleep disorder of the subject based on the determined, calibrated respiratory flow.
Observation and judgment of one or more endotypes of an obstructive sleep apnea or of another sleep disorder of the subject based on the determined, calibrated respiratory flow.
taking respective derivatives of the thoracic signal and the abdomen signal
evaluating respective derivatives of the thoracic signal and the abdomen signal
combining the derivatives using a scaling coefficient to determine the respiratory flow.
evaluating the derivatives using a scaling coefficient to determine the respiratory flow.
calculating a change of the thoracic signal and the abdomen signal each with respect to time to generate a derivative corresponding to a time derivative of a thoracic volume and abdomen volume, respectively,
evaluating a change of the thoracic signal and the abdomen signal each with respect to time to generate a derivative corresponding to a time derivative of a thoracic volume and abdomen volume, respectively
the respiratory flow is determined by combining the derivative and the another derivative using a weighted sum that is based on the first calibration coefficient.
the respiratory flow is determined by evaluating the derivative and the another derivative using a weighted sum that is based on the first calibration coefficient.
calculating a time derivative of a calibrated sum of the thoracic signal and the abdomen signal
evaluating a time derivative of a calibrated sum of the thoracic signal and the abdomen signal
first calibration is determined using the thoracic signal and the abdomen signal in an absence of any directly-measured flow signal obtained by a flow sensor, and also if the absence of flow signals measured by one or more nasal canula
first calibration is observed, judged, and evaluated using the thoracic signal and the abdomen signal in an absence of any directly-measured flow signal obtained by a flow sensor, and also if the absence of flow signals measured by one or more nasal canula
the first calibration is carried out by selecting a value of the calibration coefficient that minimizes a function that represents a ratio of numerator to a denominator,
the first calibration is carried out by observation and judgment of a value of the calibration coefficient that minimizes a function that represents a ratio of numerator to a denominator,
wherein the first calibration is carried out by finding the value of k that satisfies to a predetermined threshold equation
wherein the first calibration is carried out by observation, judgement, and evaluation of the value of k that satisfies to a predetermined threshold equation
the first calibration is carried out using a PowerLoss calibration method.
the first calibration is evaluated using a PowerLoss calibration method.
determining a correlation factor between the thoracic signal and the abdomen signal,
observation, judgement, and evaluation of a correlation factor between the thoracic signal and the abdomen signal,
calculating an overestimation correction factor based on the correlation factor
evaluating an overestimation correction factor based on the correlation factor
the determining of the respiratory flow further includes scaling the thoracic signal and abdomen signal or a derivative of a weighted sum of the thoracic signal and the abdomen signal by the overestimation correction factor or a non-linearity correction factor
the observation, judgement, and evaluation of the respiratory flow further includes evaluating the thoracic signal and abdomen signal or a derivative of a weighted sum of the thoracic signal and the abdomen signal by the overestimation correction factor or a non-linearity correction factor
calculating a non-linearity correction factor based on a curve fit,
evaluating a non-linearity correction factor based on a curve fit,
all of which are grouped as mental processes or mathematical algorithm under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1, 19 and 20 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 – 16 and 18 - 20), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“first RIP belt”, “a thoracic belt”
“second RIP belt”, “an abdomen belt”
“respiratory inductance plethysmography (RIP) belts
“processor”, “one or more processors”
“computer-readable medium”
“computing system”
Additional elements recited include a RIP Belts, “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system” in Independent Claims 1, 19, and 20 (and their respective Dependent Claims 2 - 18). These components are recited at a high level of generality, , i.e., as a generic respiratory inductance plethysmography (RIP) belt performing a generic function of collecting respiratory signals; a processor performing a generic function of processing data (the receiving, determining, and performing calibration calculations); a computer-readable medium performing a generic function of storing data (the storing). These generic hardware component limitations for “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1, 19 and 20 includes pre-solution activity limitations, such as:
receiving data of a thoracic signal of a first RIP belt (or the thoracic RIP Belt) arranged proximate with a thorax of a subject;
receiving data of an abdomen signal of a second RIP belt (or the abdomen RIP Belt) arranged proximate with an abdomen of the subject; and
wherein determining the respiratory flow includes two or more calibrations
a plurality of respiratory inductance plethysmography (RIP) belts, including a thoracic belt configured to obtain a thoracic signal and an abdomen belt configured to obtain an abdomen signal; and
a processor
In addition the aforementioned extra-solution activity limitations in Independent Claims 1, 19, and 20, additional extra-solution activity limitations recited in the Dependent Claims include:
further includes a third calibration that corrects for an overestimation of flow during paradox.
the calibrated sum being based on the first calibration coefficient.
the numerator being a power of a weighted/scaled sum of the thoracic signal and the abdomen signal, wherein a weighting/scaling of the weighted/scaled sum is based on the value of the calibration coefficient,
the denominator being a power of the scaled thoracic signal summed with a power of a weighted/scaled abdomen signal, which is the abdomen signal that has been weighted/scaled sum is based on the value of the calibration coefficient,
wherein a weighting/scaling factor used to weight/scale the thoracic signal relative to the abdomen signal is the calibration coefficient or a function of the calibration coefficient.
PNG
media_image1.png
48
389
media_image1.png
Greyscale
wherein RMS is the root mean square, k is a test value of the calibration coefficient, dRIPth represents a derivative of the thoracic signal with respect to time, dRIPab represents a derivative of the abdomen signal with respect to time.
the curve fit having been generated from calibration data that includes the respiratory flow, which is uncorrected for the non-linearity, and a reference flow, which is measured using trusted/validated method and is acquired concurrently with the respiratory flow of the calibration data, and
wherein the curve fit for the calculating of the non-linearity correction factor has an exponential functional form and the non-linearity correction factor is an exponent.
A computer readable medium having stored thereon instructions that, when executed by one or more processors of a computing system cause the one or more processors to execute the steps
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system” as recited in Independent Claims 1, 19, and 20 (and their respective Dependent Claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in independent Claims 1, 19 and 20 (and their dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these 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. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 19 and 20 (and their dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 19, and 20 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 16 and 18 - 20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system” as recited in independent Claims 1, 19, and 20 (and their dependent claims).
The additional elements of the “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system” in independent Claims 1, 19, and 20 (and their dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; is described generically in [048], [058] – [060], [063], [065], that “RIP belts measure an inductance from which changes in the length of the belts can be determined” and they are placed around the thorax and abdomen to capture respiratory movements. They are shown as “(RIP) stretchable belts 351 and 352” in FIG 3, “stretchable belts 31, 32” in Fig 2B, “stretchable belt 31” and “conductor 34" in Fig 2c, and “(RIP) stretchable belts 451 and 452” in FIG 4.
Per Applicant’s specification, the “computer-readable medium” is described generically as in [0313], [0387], and [0410] as a medium with instructions stored thereon. Additionally, [147] describes that the method can be stored on “computer storage media”, which includes general computer storage structures like “computer hardware, such as RAM, ROM, EEPROM, solid state drives ("SSDs"), and flash memory”. The “computer-readable medium” is potentially shown as a generic box element “Memory 1002” in Figure 22.
Per Applicant’s specification, the “computing system“ is described generically in [0151], that the disclosure may be practiced with “many types of computer system configurations” including a list of computer types including “personal computers, desktop computers, and laptop computers.” The “computing system” is shown as a generic box element “CPU 1001” in Figure 22.
Per Applicant’s specification, the “processor” and “one or more processors” is described generically described generically in [0151], that the disclosure may be practiced with generic hardware such as “message processors”, “multi-processor systems”, and “microprocessor-based” electronics. The “one or more processors” is shown as a generic box element “signal processor 350” in Fig. 3.
Accordingly, in light of Applicant’s specification, the claimed terms “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “first RIP belt”, “a thoracic belt”, “second RIP belt”, “an abdomen belt”, “respiratory inductance plethysmography (RIP) belts; “processor”, and “one or more processors”; “computer-readable medium”, and “computing system”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements 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) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in independent Claims 1, 19, and 20 (and their dependent claims) amounts to mere instructions to implement the abstract idea on a computer. Simply using 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 Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and apparatuses of Claims 1 – 16 and 18 - 20 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 16 and 18 - 20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in independent Claims 1, 19, and 20 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 16 and 18 - 20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 16 and 18 - 20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 16 and 18 - 20 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1—7, 9—13, and 18 –20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Höskuldsson et. al., (United States Patent Application Publication US 2018/0049678 A1), hereinafter Höskuldsson 2018.
Regarding Claims 1, 19, and 20, Höskuldsson 2018 discloses
Claim 1: A computer-implemented method for determining a respiratory flow of a subject from data from respiratory inductance plethysmography (RIP) signals obtained from the subject ([Abstract], Fig 1a and 1b; [0017] – [0018]), the method comprising:
Claim 19: A device for determining a respiratory flow from data from respiratory inductance plethysmography (RIP) signals ([Abstract], Fig 1a and 1b), the device comprising:
a processor ([0188] “one or more processors”) configured to
Claim 20: A system ([Abstract], Fig 1a and 1b), comprising:
a plurality of respiratory inductance plethysmography (RIP) belts ([0019] “RIP belts”), including a thoracic belt (Figs 1a and 1 b, “stretchable belt 31” and “conductor 34”) configured to obtain a thoracic signal ([0036] “…a value is obtained…”; [0015] “thoracic effort signal (T)”) and an abdomen belt (Figs 1a and 1 b, “stretchable belt 32” and “conductor 35”) configured to obtain an abdomen signal ([0036] “…a value is obtained…”; [0015] “abdomen effort signal (A)”); and
a processor ([0188] “one or more processors”) configured to
For the remainder of Claims 1, 19, and 20 Höskuldsson 2018 discloses:
receiving data by one or more processors ([0017] – [0018] “one or more processors, implement a method…”) of a thoracic signal ([0015] “thoracic effort signal (T)”) of a first RIP belt arranged proximate with a thorax of a subject (Figs 1a and 1 b, “stretchable belt 31” and “conductor 34”; [0036] “…a value is obtained…”)
receiving by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) data of an abdomen signal ([0015] “abdomen effort signal (A)”); of a second RIP belt arranged proximate with an abdomen of the subject (Figs 1a and 1 b, “stretchable belt 32” and “conductor 35”; [0036] “…a value is obtained…”) and
determining by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a respiratory flow of the subject based on the data of the thoracic signal and the data of the abdomen signal ([0015] “obtaining a respiratory flow (F)”; [0035] “If the areal changes of both the
thorax and abdomen are known…the respiratory flow can be derived.”);
wherein determining the respiratory flow includes two or more calibrations performed by the one or more processors ([0012] “recalibration” after movements and changes; [0017] – [0018] “one or more processors, implement a method…”) including:
performing by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a first calibration by applying a first calibration coefficient ([0051]; Eq 5, “correctly calibrated…”, “Gain factor KA”) that relates an amplitude of a differential change ([0055] “thorax…RIP signals contain information on the total areal change of the rib cage…”)in the thoracic signal ([0051] “thorax RIP signal”, T in Eq 5) to an amplitude of a differential change ([0055] “abdomen…RIP signals contain information on the total areal change of the abdomen area…”) in the abdomen signal ([0051] “abdomen RIP signal”, A in Eq 5) to obtain a determined respiratory flow ([0015] “obtaining a respiratory flow (F)”; [0035] “If the areal changes of both the thorax and abdomen are known…the respiratory flow can be derived.”);
and performing by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a second calibration on the determined respiratory flow that corrects for a non-linearity in the determined respiratory flow ([0090] “3. Minimum Obstruction Amplitude (MOA) Optimization”; [0091] including “…calibration, by selecting the kA that minimized in the best way the VS during obstruction”, “More weight can be given to the timeframes that performed in the best way by using a non - linear weight transformation.”)
Regarding Claim 2, Höskuldsson 2018 discloses as described above, The method according to claim 1. For the remainder of Claim 2, Höskuldsson 2018 discloses further comprising a step of determining by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) one or more endotypes ([0052] “This method may be useful for respiratory analysis and sleep diagnostics.”, [0116] “power loss index… a quantitative measure of the level of partial obstruction.”) of an obstructive sleep apnea or of another sleep disorder of the subject ([0052] “…subject's suffering from sleep disordered breathing.”; [0116] “partial obstruction”) based on the determined, calibrated respiratory flow ([0091] including “…calibration, by selecting the kA that minimized in the best way the VS during obstruction”; ([0015] “obtaining a respiratory flow (F)”; [0035] including “areal changes of both the thorax and abdomen …the respiratory flow can be derived”);
Regarding Claim 3, Höskuldsson 2018 discloses as described above, The method according to claim 1. For the remainder of Claim 3, Höskuldsson 2018 discloses wherein determining the respiratory flow further includes a third calibration performed by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) that corrects for an overestimation of flow during paradoxical movement of the abdomen and thorax ([0062] – [0068] Equations 6 and 7 with KA and KVT, “…paradox component P”…” by summing the two, the P and -P cancel the effect of each other, as this movement is not contributing any respiratory volume.”; [0074] “In a correctly calibrated system, the paradox component P is equivalent to, but opposite in amplitude in both thorax and abdomen signals.”; [0094] “…maintaining minimal paradoxical components”)(Examiner notes that failing cancelling out or minimizing the “paradox component” leads to an overestimation of the flow. Therefore, minimizing or cancelling this quantity corrects for an overestimation.)
Regarding Claim 4, Höskuldsson 2018 discloses as described above, The method according to claim 1. For the remainder of Claim 4, Höskuldsson 2018 discloses wherein the method further comprises taking by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) respective derivatives of the thoracic signal ([0168] “the first derivative of T (T')”) and the abdomen signal ([0168] “the first derivative…and (A')”) and combining the derivatives using a scaling coefficient ([0168] “to minimize the residues of the PT and PA resulting in a Respiratory Flow proportional signal FS”; [0167] “kA is selected by seeking a value of kA that minimizes the residues of the PT and PA components in the resulting sum Vs)· to determine the respiratory flow ([0168] “..resulting in a Respiratory Flow proportional signal FS”); [0063]).
Regarding Claim 5, Höskuldsson 2018 discloses as described above, The method according to claim 1, wherein determining of the respiratory flow. For the remainder of Claim 5, Höskuldsson 2018 discloses includes
calculating by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a change of the thoracic signal with respect to time to generate a derivative corresponding to a time derivative of a thoracic volume ([0168] “the first derivative of T (T')”),
calculating by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a change of the abdomen signal with respect to time to generate another derivative corresponding to a time derivative of an abdomen volume ([0168] “the first derivative…and (A')”), and
combining by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) the derivative and the another derivative ([0168] …”the first derivative of T (T') and A (A') are used instead of the T and A to minimize the residues of the PT and PA resulting in a Respiratory Flow proportional signal FS “; [0063]) using a weighted sum that is based on the first calibration coefficient [0165] - [0167] “weighted sum of the T and A signals…VS”, “kA is selected by seeking a value of kA that minimizes the residues of the PT and PA...resulting sum Vs”; [0051] “Gain factor KA”))
Regarding Claim 6, Höskuldsson 2018 discloses as described above, The method according to claim 1, wherein determining of the respiratory flow. For the remainder of Claim 6, Höskuldsson 2018 discloses includes calculating by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a time derivative of a calibrated sum of the thoracic signal and the abdomen signal ([0165] – [0168] “the weighted sum of the T and A signals is used to derive a Volume proportional signal VS”; [0175] “a method is provided for evaluating flow … with the first derivative of VS)·, the calibrated sum being based on the first calibration coefficient ([0167] “a value of kA “; [0051] “Gain factor KA”))
Regarding Claim 7, Höskuldsson 2018 discloses as described above, The method according to claim 1, For the remainder of Claim 7, Höskuldsson 2018 discloses includes wherein the first calibration is determined by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) using the thoracic signal and the abdomen signal ([0051] and Equation (5), KA , A, and T) in an absence of any directly-measured flow signal obtained by a flow sensor (([0051] “The QDC algorithm allows a qualitative calibration of the RIP signals during normal breathing to estimate the KA without the use of a reference volume signal.”)(Examiner notes the 112(b) interpretation as in the absence of any directly-measured flow signal obtained by a flow sensor)
Regarding Claim 9, Höskuldsson 2018 discloses as described above, The method according to claim 1, For the remainder of Claim 9, Höskuldsson 2018 discloses includes the first calibration is carried out by selecting by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a value of the calibration coefficient ([0088- [0089] “Sl min; [0089] “MSA method seeks by trial and error for a given period the KA …”) that minimizes a function that represents a ratio of numerator to a denominator ([0088] – [0089] “Minimum Signal Amplitude Optimization”, “minimizes the resulting signal compared with the amplitude of T and KAA”; Eq 11)
the numerator being a power of a weighted/scaled sum of the thoracic signal and the abdomen signal (Eq 11, RMS(Vs); [0089] Vs = T + KAA)(Examiner notes that this term includes scaling by KA), wherein a weighting/scaling of the weighted/scaled sum is based on the value of the calibration coefficient [0089] Vs = T + KAA; [0051] “Gain factor KA”),
the denominator being a power of the scaled thoracic signal ([0089], Equation 11, RMS(T)) Examiner notes that the thoracic signal is scaled by 1.) summed with a power of a weighted/scaled abdomen signal ([0089], Equation 11 “+ RMS(KAA)”, scaled by kA), which is the abdomen signal that has been weighted/scaled sum is based on the value of the calibration coefficient ([0089] Vs = T + KAA; [0051] “Gain factor KA”),
wherein a weighting/scaling factor used to weight/scale the thoracic signal relative to the abdomen signal is the calibration coefficient or a function of the calibration coefficient ([0088- [0089] “Sl min is calculated wherein KA; ([0088- [0089] “Sl min; [0089] “MSA method seeks by trial and error for a given period the KA …”; [0051] “Gain factor KA”)
Regarding Claim 10, Höskuldsson 2018 discloses as described above, The method according to claim 1, For the remainder of Claim 10, Höskuldsson 2018 discloses includes
wherein the first calibration is carried out by finding by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) the value of k that satisfies to a predetermined threshold the equation
PNG
media_image1.png
48
389
media_image1.png
Greyscale
([0166] “the ratio of the weights for A towards T is kA “: Examiner notes that the ratio of the weights for T towards A would then be
k
t
= (1 - kA); [0061] “thorax and abdomen could have weights other than 1””
V
s
w
=
k
t
T
+
k
A
A
”: Examiner notes plugging in
k
t
= (kA – 1) yields
V
s
w
=
(
1
-
k
A
)
T
+
k
A
A
; [0155] “evaluating the ratio of signal loss Sl “”ratio of…power or any transformation f” using middle term
f
T
'
+
k
A
A
'
f
T
'
+
f
(
k
A
A
'
)
; [0168 – 0169] “…T (T’) and A (A’) are used..” [0089] minimize S with RMS function, Eq 11: (Examiner notes, with the
k
t
= (1 - kA) weighting yields
f
1
-
k
A
T
'
+
k
A
A
'
f
(
1
-
k
A
T
'
+
f
(
k
A
A
'
)
, where f is RMS function.)
wherein RMS is the root mean square ((Eq 11, RMS), k is a test value of the calibration coefficient ([0089] “kA” “A MSA method seeks by trial and error for a given period”; dRIPth represents a derivative of the thoracic signal with respect to time ([0168] “the first derivative of T (T')”), dRIPab represents a derivative of the abdomen signal with respect to time ([0168] “the first derivative…and (A')”).
Regarding Claim 11, Höskuldsson 2018 discloses as described above, The method according to claim 1, For the remainder of Claim 11, Höskuldsson 2018 discloses includes wherein the first calibration is carried out using by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a PowerLoss calibration method ([0026] – [0028]; [0112] - [0115] “index is the same as is used to seek the calibration value kAA…””kA that results in the minimum…that value as a power loss index”).
Regarding Claims 13 and 12, Höskuldsson 2018 discloses, The method according to claim 3 (See citation above), wherein the third calibration includes steps of determining by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a correlation factor between the thoracic signal and the abdomen signal ([0070] “a constant, tc and (1-tc)”), and
calculating by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) an overestimation correction factor based on the correlation factor ([0070] including “scaled with the correct value of x” and “xAb=tcS+P and (1-x)Th=(l-tc)S-P, where S=xAb+(lx)Th”; “The flow contributing parts of xAb and (1-x)Th are in phase and the paradox, non-flow contributing parts P cancel each other when xAb and (1-x)Th are scaled with the correct value of x and added.”) and
For the remainder of Claim 13, Höskuldsson 2018 discloses and the determining of the respiratory flow further includes scaling by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) the thoracic signal and the abdomen signal by the overestimation correction factor ([0070] “The flow contributing parts of xAb and (1-x)Th are in phase and the paradox, non-flow contributing parts P cancel each other when xAb and (1-x)Th are scaled with the correct value of x and added.”, “…respiratory flow (F) of the subject may be found by derivation”; [0069] including “xAb=tcS+P and (1-x)Th=(l-tc)S-P, where S=xAb+(lx)Th”)
For the remainder of Claim 12, Höskuldsson 2018 discloses and the determining of the respiratory flow further includes scaling by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a derivative of a weighted sum of the thoracic signal and the abdomen signal by the overestimation correction factor ([0070], [0069], [0168] including “instead of processing the respiratory effort signals T and A, the first derivative of T (T') and A (A') are used instead of the T and A to minimize the residues of the PT and PA resulting in a Respiratory Flow proportional signal Fs·”; [0167] “weighted sum of the T and A signals…”, “value of kA that minimizes the residues of the PT and PA”) Examiner notes that the calculation proceeds similarly to Claim 13, where the substitution of T’ and A’ occurs in those equations of Claim 12)
Regarding Claim 18, Höskuldsson 2018 discloses A non-transitory computer readable medium having stored thereon instructions that ([0191] “hardware storage device has stored thereon computer executable instructions…”), when executed by one or more processors of a computing system cause the one or more processors ([0191] “one or more processors”) to execute the steps of the method ([Abstract]; [[0191]) according to claim 1 (See citation in Claim 1 above).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Höskuldsson 2018 In view of Höskuldsson et. al, (United States Patent Application Publication US 2019/0274586 A1), hereinafter Höskuldsson 2019.
Regarding Claim 8, Höskuldsson 2018 discloses as described above, The method according to claim 1, wherein the first calibration is determined by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) using the thoracic signal and the abdomen signal in an absence of any directly-measured flow signal obtained (See Claim 7 for citation). For the remainder of Claim 8, Höskuldsson 2018 does not specifically disclose obtained by one or more nasal canulas.
Höskuldsson 2019 teaches a non-invasive method and system for determining respiratory flow and respiratory effort using calibrated RIP belt sensors. Specifically for Claim 8, Höskuldsson 2019 teaches in an absence of any directly-measured flow signal obtained by one or more nasal canulas ([0078] “Since the nasal cannula does not account for oral breathing and tends to dislocate during sleep it can, for simplicity, be omitted, and the RIP belts can be used as the primary flow measurement device.”).
Höskuldsson 2019 provides a motivation to combine at [0078], since “the nasal cannula does not account for oral breathing and tends to dislocate during sleep”, and it can be “for simplicity, be omitted”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that performing the calibration without the need for an extra cannula would allow for simpler, more consistent measurements for instrumented sleep studies. As the calibration method disclosed by Höskuldsson 2018 already uses [0051] a method to calibrate “without the use of a reference volume signal.” it would have been predictable to perform the calibrations without requiring nasal cannula flow signals, as taught by Höskuldsson 2019.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to not include a nasal cannula as an extra flow measuring device when performing RIP belt system calibration, in order to have a simpler instrumentation and consistent measurements in sleep studies.
Claims 14 - 15 are rejected under 35 U.S.C. 103 as being unpatentable over Höskuldsson 2018 In view of Seppänen et. al. “Reducing the airflow waveform distortions from breathing style and body position with improved calibration of respiratory effort belts”, hereinafter Seppänen.
Regarding Claims 15 and 14, Höskuldsson 2018 discloses The method according to claim 1, wherein the second calibration includes steps of calculating by the one or more processors a non-linearity correction factor ([0090] – [0091]; [0017] – [0018] “one or more processors, implement a method…”)
For both Claims 15 and 14, Höskuldsson 2018 does not disclose based on a curve fit, the curve fit having been generated from calibration data that includes the respiratory flow, which is uncorrected for the non-linearity, and a reference flow, which is measured using trusted/validated method, and is acquired concurrently with the respiratory flow of the calibration data
Seppänen teaches a method of calibrating inductive-based respiratory effort belts with spirometer respiratory airflow measurements using multiple linear regression curve fitment. Specifically for Claims 15 and 14, Seppanen teaches calculating a non-linearity correction factor ([Page 3 and 4 “Proposed calibration method” section] “β”,. “β 1 T and β 2 T “) based on a curve fit ([Page 3, 2nd Full paragraph] “…applying the method of multiple linear regression”)(Examiner notes that multiple linear regression can be used to model an overall non-linear system.), the curve fit having been generated from calibration data that includes the respiratory flow, which is uncorrected for the non-linearity ([Page 3, 2nd Full paragraph] “dimensional changes of the respiratory effort belt signals”), and a reference flow, which is measured using trusted/validated method ([Page 3, 2nd Full paragraph] “respiratory airflow from spirometer”), and is acquired concurrently with the respiratory flow of the calibration data ([Page 3, 2nd Full paragraph] “…time-synchronized signals”), and
For the remainder of Claim 15, Höskuldsson 2018 discloses the determining of the respiratory flow further includes scaling by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) the thoracic signal and the abdomen signal by the non-linearity correction factor ([0090] “3. Minimum Obstruction Amplitude (MOA) Optimization”; [0091] including “…calibration, by selecting the kA that minimized in the best way the VS during obstruction”, “More weight can be given to the timeframes that performed in the best way by using a non - linear weight transformation.”).
Seppänen also teaches the determining of the respiratory flow further includes scaling the thoracic signal and the abdomen signal by the non-linearity correction factor ([Page 3, 3rd Full Paragraph] x = belt signals, β = regression coefficients (correction factor), y = flow) Eq 1 ; [Page 4], Eq 3
PNG
media_image2.png
27
147
media_image2.png
Greyscale
)
Seppänen provides a motivation to combine at [Page 4, Paragraph 1] that fitting the belt signal waveforms to the spirometer signal waveform with the multiple linear regression allows the “the result of the prediction much more accurate than with the standard method”, as well as “selected nonlinear components can be included in the system”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that it would be useful to use multiple non-linear regression in order to obtain higher accuracy with tunable non-linear elements.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute Höskuldsson 2018’s non-linear MAO fitment method of fitment between RIP sensors and a flow meter with Seppänen’s multiple linear regression method of fitment between RIP signals and flow meter data, for a tunable calibration fitment for non-linear elements.
For the remainder of Claim 14, Höskuldsson 2018 discloses the determining of the respiratory flow further includes scaling by the one or more processors ([0017] – [0018] “one or more processors, implement a method…”) a derivative ([0169] “…any of the embodiments above or below, any level of…derivative of T and A are used”) of a weighted sum of the thoracic signal and the abdomen signal by the non-linearity correction factor ([0090] “3. Minimum Obstruction Amplitude (MOA) Optimization”; [0091] including “…calibration…selecting the kA…a non - linear weight transformation.”). .
Seppänen teaches the determining of the respiratory flow further includes scaling the thoracic signal and the abdomen signal by the non-linearity correction factor ([Page 3, 3rd Full Paragraph] x = belt signals, β = regression coefficients (correction factor), y = flow) Eq 1 ; [Page 4], Eq 3
PNG
media_image2.png
27
147
media_image2.png
Greyscale
; [Page 2, 1st full paragraph] “the derivative of the respiratory volume yields respiratory flow”)
The motivation for Claim 14 to combine Höskuldsson 2018 with Seppänen is the same as that described in Claim 15. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute Höskuldsson 2018’s non-linear MAO fitment method of fitment between RIP sensors and a flow meter with Seppänen’s multiple linear regression method of fitment between RIP signals and flow meter data, for a tunable calibration fitment for non-linear elements.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Höskuldsson 2018 In view of Seppänen, further in view of Schranz et. al., “Iterative integral parameter identification of a respiratory mechanics model”, hereinafter Schranz.
Regarding Claim 16, Höskuldsson 2018 in view of Seppänen discloses The method according to claim 15, wherein the curve fit for the calculating of the non-linearity correction factor. For the remainder of Claim 16, Höskuldsson 2018 does not disclose has an exponential functional form and the non-linearity correction factor is an exponent.
Schranz teaches an exponential function fitment of respiratory mechanics data, as an alternative to multiple linear regression curve fitment. Specifically for Claim 16, Schranz teaches wherein the curve fit for the calculating of the non-linearity correction factor has an exponential functional form and the non-linearity correction factor is an exponent ([Page 7, 1st full paragraph] “the time constant τ of the exponential pressure drop…fitted by an exponential function”)
Schranz provides a motivation to combine at [Page 7, 1st full paragraph] with “This method improved the robustness of the subsequent parameter identification significantly by reducing the potential for poorly estimated initial values to result in local minima identification” and [Abstract] “Multiple linear regression or gradient-based parameter identification methods are highly sensitive to noise and initial parameter estimates…they are difficult to apply at the bedside to support therapeutic decisions.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that an exponential function is another type of curve fitting that is effective for non-linear data fitting of respiratory flow data, as is the multiple linear regression disclosed by Höskuldsson 2018 in view of Seppänen, and that it would be useful for fitting respiratory data for therapeutic decisions. As they are both non-linear data fitting methods, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the multiple linear regression curve fitting disclosed by Höskuldsson 2018 in view of Seppänen with the exponential curve fitting taught by Seppänen to improve the robustness of the estimation using an alternative method. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Response to Arguments
Applicant's arguments filed 02 FEBRUARY 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 Rejections:
Applicant argues at [Page 13, “Rejection of Claims 1 – 20 under 35 U.S.C. 101” Section, Paragraph 1 - 3] that claim 1 is integrated into a particular machine, a processor, and that the steps cannot be considered to cover concepts that can be performed in the human mind using pen and paper. The limitations of receiving are each broadly the act of a researcher obtaining a file or print-off of graphical or tabulated RIP sensor data signals. The determining a respiratory flow of the subject based on the data of the thoracic signal and the data of the abdomen signal and performing a first calibration and performing a second calibration can broadly encompass a researcher applying equations and observation and judgment of the result with the air of their education, background, experience, time, and a pen and paper or a processor with calculation software used as a tool in a usual way. There is nothing claimed about the processor itself to indicate that it is more than a standard computer system used for standard processing of data. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. The argument is not persuasive.
Applicant argues at [Page 13, Bottom] – [Page 15, 3rd Full Paragraph] that Claim 1 provides significant improvements to the field of physiological studies like sleep studies, where respiratory flow of a subject is determined because they do not use a nasal cannula. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic RIP sensor components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant argues at [Page 15, Paragraph 4] – [Page 16, Top] that the features of the current pending claims as a whole are not disclose or suggested by the prior art of record, and the claims provide significant advantages over previously-known flow measuring systems by increasing accuracy of a determination of respiratory flow. From MPEP § 2106.05 I: Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.”). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (“The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.”).
The limitations do not change the functionality of any of the sensors or of the processor itself, as the claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic RIP sensor components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. The variable manipulation is not applied to a practical application to the enhance how the RIP sensors originally measure the signal or how a processor processes data. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Regarding the 35 U.S.C. 102 and 103 Rejections:
Applicant argues at [Page 16, “Rejection of claims…being anticipated by Hoskuldsson” Section] – [Page 17, Paragraph 3] and [Page 19, 1st Full Paragraph – 4th Full Paragraph] that Hoskuldsson ‘678 fails to disclose or suggest the features of claim 1 from “wherein determining the respiratory flow includes two or more calibrations” to “…corrects for a non-linearity in the determined respiratory flow” because kA does not describe a “differential change” in the thoracic signal for the first calibration. A gain factor is a factor that is used in an equation at a multiplier that relates to the term of the thoracic signal, representing a differential change to a term, in this case, the RIP signals that include the amplitude of a differential change in the thoracic and abdomen signal in equation 5. The gain term serves to calibrate the signal in this first way. The argument is not persuasive.
Applicant argues at [Page 17, Paragraph 4] – [Page 19, Top] and [Page 19, 1st Full Paragraph – 4th Full Paragraph] that Hoskuldsson ‘678 does not mention or disclose “correcting for non-linearity in the determined respiratory flow” as required in the second calibration, as using a non-linear weight transformation to give more weight to timeframes that perform best to determine a weight factor kA cannot be considered to be analogous. The non-linearity of breathing can be broadly attributed to the variation in the timing of the individual breaths, with quick changes in the signal amplitudes between breaths and periods of obstructions (Hoskuldsson ‘678: [0091]). As recited, the claim is broadly correcting for non-linearity in the determined respiratory flow, which would include applying non-linear weight factor transformation to accommodate of broadly correct for the variation in time of the breaths or the quick, non-linear changes in the signal amplitudes, as described by Hoskuldsson ‘678. The weight factor serves to calibrate the signal in this second way. The argument is not persuasive.
Applicant summarily argues at [Page 19, 5th Full Paragraph] – [Page , Bottom] that since Hoskuldsson ‘678 fails to disclose all of the elements of Claim 1, (and the further references of Hoskuldsson ‘586, Seppanen, and Shranz do not remedy the deficiencies of Hoskuldsson ‘678), then the rejections for claims 1 – 7, 8 – 13 and 18 – 20 should be withdrawn. Based on the 35 U.S.C. 102 AND 35 U.S.C. 103 rejections and the discussion of arguments above, Hoskuldsson ‘678 discloses all of the elements of Claim 1. The argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272 - 4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791