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 .
Specification
The use of the term ”Bluetooth” at [Page 15, Line 18], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 10 is objected to because of the following informalities: there appears to be an “of” missing between “system” and “claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 (line 10) and Claim 14 (line 10) each recite the limitation, “select breath intervals based on the breathing characteristics”. It is unclear if these are intended to be the same or different than the previously-recited multiple breath intervals. For the purposes of examination, the term “select breath intervals based on the breathing characteristics” is deemed to claim “select additional breath intervals based on the breathing characteristics.” Claims 2 – 13 and 15 are similarly rejected due to their respective dependence on Claims 1 and 14.
Claim 2 (line 3) recites the limitation “determine the occurrence and/or severity of sleep apnea”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited occurrence. For the purposes of examination, the term “determine the occurrence and/or severity of sleep apnea” is deemed to claim “determine an occurrence and/or a severity of sleep apnea”.
Claim 3 (lines 3 – 4) recites the limitation “setting the negative derivative filtered value to zero”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited negative derivative filtered value. For the purposes of examination, the term “setting the negative derivative filtered value to zero” is deemed to claim “setting a negative derivative filtered value to zero”.
Claim 5 (line 3) recites the limitation “and the neighboring determined valley position”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited neighboring determined valley position. For the purposes of examination, the term “and the neighboring determined valley position” is deemed to claim “and a neighboring determined valley position”.
Claim 8 (line 2 – 3) recites the limitation “as the average or median of a plurality”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited average or median of a plurality. For the purposes of examination, the term “as the average or median of a plurality” is deemed to claim “as an average or a median of a plurality”. Claim 9 is similarly rejected due to its dependence on Claim 8.
The term “average or median of a plurality of most recent selected breath intervals” in claim 8 is a relative term which renders the claim indefinite. The term “most recent selected” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear if this is intended to mean that “most” of the recently-selected intervals are used for the average or median, that the intervals that a person chose immediately prior to the average or median are used, or if they are the recorded that are closest to the current timestamp. For the purposes of examination, the term “average or median of a plurality of most recent selected breath intervals” is deemed to claim “average or median of a plurality of selected breath intervals.” Claim 9 is similarly rejected due to its dependence on Claim 8.
Claim 9 (line 2) recites the limitation “derive a final breath interval by smoothing a plurality of selected breath intervals”. It is unclear if this is intended to be the same or different than the previously-recited plurality of most recent selected breath intervals. For the purposes of examination, and in light of the interpretation above, the term “derive a final breath interval by smoothing a plurality of selected breath intervals” is deemed to claim “derive a final breath interval by smoothing the plurality of selected breath intervals”.
Claim 10 (line 2) recites the limitation “wherein the controller is configured to select the multiple breath intervals with one or more of the following breathing characteristics”. In the previously-recited claim, the multiple breath intervals were “determined”, and the selection was for the “breath intervals”. Due to the lack of clarity discussed for Claim 1 above, it is also unclear which breath intervals are intended in this claim. For the purposes of examination, the term “wherein the controller is configured to select the multiple breath intervals with one or more of the following breathing characteristics” is deemed to claim “wherein the controller is configured to select the additional breath intervals with one or more of the following breathing characteristics.” Claims 11 – 12 are similarly rejected due to their dependence on Claim 10.
Claim 11 (line 2) recites the limitation, “predict the timing of a start of a next inhalation”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited timing. For the purposes of examination, the term “predict the timing of a start of a next inhalation” is deemed to claim “predict a start time of a next inhalation.” Claim 12 is similarly rejected due to their dependence on Claim 11. The limitation in Claim 12 of “between the predicting timing of the start of the next inhalation” is similarly interpreted as “between the predicted start time of the next inhalation”.
Claim 12 (line 2) recites the limitation “determine the occurrence and/or severity of sleep apnea”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited occurrence. For the purposes of examination, the term “determine the occurrence and/or severity of sleep apnea” is deemed to claim “determine an occurrence and/or a severity of sleep apnea”.
Claim 12 (line 4) recites the limitation “the calculated inhalation to exhalation ratio”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited calculated inhalation to exhalation ratio in the claims from which Claim 12 depends. For the purposes of examination, the term “the calculated inhalation to exhalation ratio” is deemed to claim “a calculated inhalation to exhalation ratio”.
Claim 13 recites the term “a breathing signal for a subject”. It is unclear if this is intended to be the same or different than the breathing signal and subject previously-recited in Claim 1, from which this claim depends. For the purposes of examination, the term “a breathing signal for a subject” is deemed to claim “the breathing signal for the subject.”
Claim 13 recites the term “determining a breathing rate”. It is unclear if this is intended to be the same or different than the breathing rate previously-recited in Claim 1, from which this claim depends. For the purposes of examination, the term “determining a breathing rate” is deemed to claim “determining the breathing rate.”
Claim 15 recites the term “when said program is run on a computer”. It is unclear if this is intended to be the same or different than the computer and program of the previously-recited “computer program”. For the purposes of examination, the term “when said program is run on a computer” is deemed to claim “when said computer program is executed”.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim recites a “computer program comprising computer program code means which is adapted, when said program is run on a computer, to implement the method of claim 14”, which can be considered either software per se or signals per se, which are not one of the statutory categories of invention. The claim should be amended to recite “A non-transitory computer readable medium”. A suggestion would be “A non-transitory computer readable medium comprising computer program code which is executed by a computer to implement the method of claim 14”. The forthcoming 101 analysis regarding Claim 15 is provided assuming that this amendment is made.
Claims 1 - 15 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 apparatus, which is one of the statutory categories of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 14, 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).
Each of claims 1 – 15 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 15 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 – 15 recites an abstract idea.
Specifically, Claims 1 – 15 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1
A system for determining a breathing rate of a subject, comprising a controller which is configured to: receive a breathing signal for the subject;
low-pass filter the breathing signal to obtain a filtered breathing signal;
determine a transformed signal at least by obtaining a derivative signal of the filtered breathing signal;
determine multiple breath intervals from the transformed signal;
determine breathing characteristics in the filtered breathing signal for the determined multiple breath intervals;
select breath intervals based on the breathing characteristics; and
calculate a breathing rate based on the selected breath intervals.
Claim 14
A computer-implemented method for determining a breathing rate of a subject, comprising:
receiving a breathing signal for the subject;
low-pass filtering the breathing signal to obtain a filtered breathing signal;
determining a transformed signal at least by obtaining a derivative signal of the filtered breathing signal;
determining multiple breath intervals from the transformed signal;
determining breathing characteristics in the filtered breathing signal for the determined multiple breath intervals;
selecting breath intervals based on the breathing characteristics; and
calculating a breathing rate based on the selected breath intervals.
(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 and 14, these limitations include:
Observation and judgment of a breathing rate of a subject
Observation and judgment of a transformed signal at least by evaluating a derivative signal of the filtered breathing signal;
Observation and judgment of multiple breath intervals from the transformed signal;
Observation and judgment of breathing characteristics in the filtered breathing signal for the observed and judged multiple breath intervals;
Observation and judgment of breath intervals based on the breathing characteristics
Evaluating a breathing rate based on the selected breath intervals.
all of which are grouped as mental processes under the 2019 PEG.
Similarly, the Dependent Claims include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1 and 14 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
determine the occurrence and/or severity of sleep apnea based on the calculated breathing rate.
Observation and judgment of the occurrence and/or severity of sleep apnea based on the calculated breathing rate.
applying a derivative filter to the filtered breathing signal
evaluate using a derivative filter to the filtered breathing signal
setting the negative derivative filtered value to zero to obtain the derivative signal
evaluate by setting the negative derivative filtered value to zero to obtain the derivative signal
applying a slope sum filter to the derivative signal.
evaluate by applying a slope sum filter to the derivative signal.
detect a peak in the transformed signal;
Observation and judgment of a peak in the transformed signal;
determine a peak position and a valley position in the filtered breathing signal, which correspond to the detected peak in the transformed signal
Observation and judgment of a peak position and a valley position in the filtered breathing signal, which correspond to the detected peak in the transformed signal
determine the breathing characteristics based on the determined peak position and valley position.
Observation and judgment of the breathing characteristics based on the Observation and judgment of peak position and valley position.
determine a height difference between an inhalation and exhalation as a magnitude difference between the determined peak position and the neighboring determined valley position in the filtered breathing signal.
Observation and judgment of a height difference between an inhalation and exhalation as a magnitude difference between the determined peak position and the neighboring determined valley position in the filtered breathing signal.
determine an inhalation duration and an exhalation duration, based on the determined peak position and valley position in the filtered breathing signal.
Observation and judgment of an inhalation duration and an exhalation duration, based on the determined peak position and valley position in the filtered breathing signal.
calculate an inhalation to exhalation ratio based on the determined inhalation duration and the determined exhalation duration.
evaluate an inhalation to exhalation ratio based on the determined inhalation duration and the determined exhalation duration.
derive a candidate breath interval as the average or median of a plurality of most recent selected breath intervals
evaluate a candidate breath interval as the average or median of a plurality of most recent selected breath intervals
calculate the breathing rate based on the candidate breath interval.
evaluate the breathing rate based on the candidate breath interval.
derive a final breath interval by smoothing a plurality of selected breath intervals,
evaluate a final breath interval by smoothing a plurality of selected breath intervals,
calculate the breathing rate based on the final breath interval.
evaluate the breathing rate based on the final breath interval.
select the multiple breath intervals with one or more of the following breathing characteristics:
a height difference within a predetermined height range; an inhale upstroke which is increasing stably; a breathing signal with a mean value within a predetermined mean range; a breathing signal with one or more higher order parameters within predetermined respective parameter ranges; and/or a cosine similarity of consecutive breathing waveforms of the breathing signal within a predetermined similarity range.
Observation and judgment of the multiple breath intervals with one or more of the following breathing characteristics: a height difference within a predetermined height range; an inhale upstroke which is increasing stably; a breathing signal with a mean value within a predetermined mean range; a breathing signal with one or more higher order parameters within predetermined respective parameter ranges; and/or a cosine similarity of consecutive breathing waveforms of the breathing signal within a predetermined similarity range.
predict the timing of a start of a next inhalation based on a most recent valley position, a breath interval based on lengths of previously selected breathing intervals and a phase delay caused by the low-pass filtering.
Observation and judgment to predict the timing of a start of a next inhalation based on a most recent valley position, a breath interval based on lengths of previously selected breathing intervals and a phase delay caused by the low-pass filtering.
determine the occurrence and/or severity of sleep apnea based on a comparison between the predicted timing of the start of the next inhalation and an actual timing of the start of the next inhalation, and/or the calculated inhalation to exhalation ratio.
Observation and judgment of the occurrence and/or severity of sleep apnea based on a comparison between the predicted timing of the start of the next inhalation and an actual timing of the start of the next inhalation, and/or the calculated inhalation to exhalation ratio.
all of which are grouped as mental processes 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 and 14 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 14), 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:
“controller”
“sensor arrangement”
“computer program”
“computer”
Additional elements recited include an “controller”, “sensor arrangement”, “computer program”, “computer” in the Independent Claims 1 and 14 their dependent claims. These generic hardware component limitations for “controller”, “sensor arrangement”, “computer program”, “computer” 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 and 14 include pre-solution activity limitations, such as:
receive a breathing signal for the subject;
low-pass filter the breathing signal to obtain a filtered breathing signal;
In addition to the aforementioned extra-solution activity limitations in Independent Claims 1, and 14, additional extra-solution activity limitations recited in the Dependent Claims include:
a sensor arrangement for generating a breathing signal for a subject
A computer program comprising computer program code means, which is adapted, when said program is run on a computer
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 “controller”, “sensor arrangement”, “computer program”, “computer” as recited in Independent Claims 1 and 14 and their 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 and 14 (and their respective 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 and 14 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 14 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 15 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: “controller”, “sensor arrangement”, “computer program”, “computer” as recited in Independent Claims 1 and 14 and their dependent claims.
The additional elements of the “controller”, “sensor arrangement”, “computer program”, “computer” in Claims 1 - 15, 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 “controller” is described generically in [Page 9, Bottom] with “The system 14 comprises a controller which processes the breathing signal BS” and [Page 17, 2nd Full Paragraph] as a generic processor with “software which controls a processor to perform the signal analysis…” The computer is shown as generic block element “system 14” in Figure 1.
Per Applicant’s specification, the “sensor arrangement” is described generically at [Page 10, Paragraph 1] with “The breathing signal can be obtained by any suitable sensor forming part of a sleep monitoring application for detecting respiratory vibrations or flows, such as a pillow or a mattress, or a bed side system using a radar or ultrasound, or piezoelectric sensor, or an air flow sensor.” The “sensor arrangement” is shown as generic block element 12 in Figure 1.
Per Applicant’s specification, the “computer program” is described generically in [Page 17, 2nd Full Paragraph] with “software comprises a computer program, i.e. computer program code means, which is run by a processor forming part of the analysis system. The computer program is for example embodied as a computer program medium (i.e. a memory device).”
Per Applicant’s specification, the “computer” is described generically in [Page 17, 2nd Full Paragraph] as a processor, since it is used to run the “computer program” with “software which controls a processor to perform the signal analysis. The software comprises a computer program, i.e. computer program code means, which is run by a processor forming part of the analysis system…” The computer is shown as generic block element “system 14” in Figure 1.
Accordingly, in light of Applicant’s specification, the claimed terms “controller”, “sensor arrangement”, “computer program”, “computer” 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 “controller”, “sensor arrangement”, “computer program”, “computer”. 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 Claims 1 – 15 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 apparatus and method of Claims 1 - 15 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 - 15 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 and 14 (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 - 15 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 - 15 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 - 15 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 – 2, 4, 6, 8 – 10, and 13 – 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sarkar et. al., (US 2020/0397308 A1).
Regarding Claims 1 and 14, Sarkar discloses
For Claim 1:
A system for determining a breathing rate of a subject ([Abstract]), comprising a controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) which is configured to:
For Claim 14:
A computer-implemented method for determining a breathing rate of a subject ([Abstract]; Fig. 3; [0040]), comprising:
For both Claim 1 and Claim 14:
receive a breathing signal for the subject (Fig. 9, “Receive a first set of impedance values” 902; [0027] “…the impedance data may be analyzed to distinguish between different types of breathing…”);
low-pass filter the breathing signal to obtain a filtered breathing signal ([0031] “…the IMD may apply a high-pass filter and a low-pass filter to the impedance data”);
determine a transformed signal at least by obtaining a derivative signal of the filtered breathing signal ([0137] “…an impedance derivative plot 720…derivative signal 722…”; [0139]; Fig. 7);
determine multiple breath intervals from the transformed signal ([0139] “…comparing derivative signal 722 with auto-adjusting thresholds 724, 726, processing circuitry 14 may improve an accuracy in which respiration intervals are identified…”; [0137] “…FIG. 7 illustrates respiration intervals derived from positive zero crossings 716A-716C “);
determine breathing characteristics in the filtered breathing signal for the determined multiple breath intervals ([0032] “…the IMD may determine a set of respiratory intervals, where each respiratory interval represents a full respiratory cycle of inhaling and exhaling…calculate a mean respiratory interval…”; [0027] “…impedance data may be analyzed to distinguish between different types of breathing (e.g., eupnea (normal breathing), apnea, Cheyne-Stokes breathing, dyspnea, hyperpnea, hyperventilation, hypopnea, hypoventilation, tachypnea…”; [0097] – [0099]);
select breath intervals based on the breathing characteristics ([0006] “…identify the set of respiratory intervals”; [0032] “…Based on the mean respiratory interval…may calculate the respiration rate…”; [0097] – [0099] “…valid impedance measurements…”); and
calculate a breathing rate based on the selected breath intervals ([0006] “….calculate the respiration rate based on the set of respiratory intervals”; [0099] “…Respiration Rate is equal to 60*8/(Median Respiration cycle lengths in number of samples during valid impedance segments) breaths per minute …”).
Regarding Claim 2, Sarkar discloses as described above, The system of claim 1. For the remainder of Claim 2, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is further configured to:
determine the occurrence and/or severity of sleep apnea based on the calculated breathing rate ([0142] “…patient conditions such as…sleep apnea… processing circuitry 14 may process the impedance data to determine one or more parameters (e.g., respiratory rate, respiratory rate variability… associated with respiratory cycles of the patient… analyze such parameters to identify or monitor one or more medical conditions.”)
Regarding Claim 4, Sarkar discloses as described above, The system of claim 1. For the remainder of Claim 4, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to:
detect a peak in the transformed signal ([0061] “…correspond to mid-points or peaks in patient 4's inhale phases and exhale phases..
determine a peak position ([0093] “…positive peaks…”; Fig. 13, “…maximum impedance value…”) and a valley position ([0093] “…negative peaks…”; Fig. 13, “minimum impedance value…”) in the filtered breathing signal, which correspond to the detected peak in the transformed signal ([0061] mid-points or peaks in patient 4’s inhale phases and exhale phases“; [0093] “…positive peaks…negative peaks…”; Fig. 8; Fig. 13); and
determine the breathing characteristics based on the determined peak position and valley position ([0093] “…group of positive peaks and a group of negative peaks…peak-to-peak value…”; [0094] “… the set of features includes the peak-to-peak amplitude of the respiration waveform and a patient motion level…”).
Regarding Claim 6, Sarkar discloses as described above, The system of claim 4. For the remainder of Claim 6, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to determine an inhalation duration ([0061] “…inhale phases…”; Fig. 7; [0137]; [0043] “…impedance measurements may be conducted for a measurement duration…”; [0143] “…each respiratory cycle includes an inhale phase and an exhale phase.”; [0089] – [0090]) and an exhalation duration ([0061] “…exhale phases…”; Fig. 7; [0137]; [0043] “…impedance measurements may be conducted for a measurement duration…”; [0143] “…each respiratory cycle includes an inhale phase and an exhale phase.”; [0089] – [0090]), based on the determined peak position and valley position in the filtered breathing signal ([0061] “…the third set of secondary impedance values (e.g., the derivative of the second set of secondary impedance values…Zero crossings in the impedance signal may approximately correspond to mid-points or peaks in patient 4's inhale phases and exhale phases…”; [0058] “…may apply a low pass filter to the first set of secondary impedance values in order to obtain the second set of secondary impedance values.”; Fig. 7)(Examiner notes that zero crossings in the derivative signal “third set” would correspond to peaks and valleys in the “second set of secondary impedance values”.)
Regarding Claim 8, Sarkar discloses as described above, The system of claim 1. For the remainder of Claim 8, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to derive a candidate breath interval as the average or median of a plurality of most recent selected breath intervals ([0148] “…Using the set of respiration cycles, processing circuitry 14 may calculate a mean respiration cycle, determine a median respiration cycle…”; [0155] “…a moving average of the first set of impedance values…”; Fig 9, Fig 8), and the controller is further configured to calculate the breathing rate based on the candidate breath interval ([0148] “…processing circuitry 14 may calculate a respiration rate corresponding to a median respiration cycle of the set of respiration cycles.”; [0098] “…to calculate the respiration rate, processing circuitry 14 is configured to combine the first set of respiration intervals and the second set of respiration intervals into a third set of respiration intervals…”).
Regarding Claim 9, Sarkar discloses as described above, The system of claim 8. For the remainder of Claim 9, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to derive a final breath interval by smoothing a plurality of selected breath intervals ([0054] “… IMD 10 may apply a 64-point smoothing filter and subtract an output of the smoothing filter from the original impedance signal to remove DC and linear components of the impedance signal…”; [0146] - [0148] including “…collects the set of impedance values…’, “…filter out high-frequency and low-frequency components…”, “…Using the set of respiration cycles, processing circuitry 14 may calculate a mean respiration cycle, determine a median respiration cycle…”), and the controller is further configured to calculate the breathing rate based on the final breath interval ([0098] “…to calculate the respiration rate, processing circuitry 14 is configured to combine the first set of respiration intervals and the second set of respiration intervals into a third set of respiration intervals…”).
Regarding Claim 10, Sarkar discloses as described above, The system of claim 1. For the remainder of Claim 10, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to select the multiple breath intervals [0006] “…identify the set of respiratory intervals”; [0032] “…Based on the mean respiratory interval…may calculate the respiration rate…”; [0097] – [0099] “…valid impedance measurements…”) with one or more of the following breathing characteristics:
a height difference within a predetermined height range ([0095] “…Determine that an impedance measurement is valid for determining respiration parameters, in some cases, the peak-to-peak amplitude of the respiration waveform must be greater than a peak-to-peak threshold”);
an inhale upstroke which is increasing stably;
a breathing signal with a mean value within a predetermined mean range;
a breathing signal with one or more higher order parameters within predetermined respective parameter ranges ([0090] “…an impedance measurement is valid if a number of positive zero-crossing intervals is greater than zero…”); and/or
a cosine similarity of consecutive breathing waveforms of the breathing signal within a predetermined similarity range.
Regarding Claim 13, Sarkar discloses A breathing monitoring system ([Abstract]; Fig. 3), comprising: a sensor arrangement for generating a breathing signal for a subject (Fig. 3, “sensor(s) 62 and “sensing circuitry 52”); and the system for determining a breathing rate of claim 1 (See citation above).
Regarding Claim 15, Sarkar discloses A computer program comprising computer program code means ([0129] – [0130]), which is adapted, when said program is run on a computer ([0129] “…Storage device 84 may be used by software or applications running on external device 12 to temporarily store information during program execution…processing circuitry 80…”), to implement the method of claim 14 (See citations 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sarkar in view of Su et. al., (US 2016/0113618 A1), further in view of Liu et. al., “A Novel Beat Detection Method for Blood Pressure Signals Using Slope Sum Mean Shift Technology”.
Regarding Claim 3, Sarkar discloses as described above, The system of claim 1. For the remainder of Claim 3, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to determine the transformed signal ([0137] “…an impedance derivative plot 720…derivative signal 722…”; [0139]; Fig. 7); by:
applying a derivative filter to the filtered breathing signal ([0137] “…an impedance derivative plot 720…derivative signal 722…”; [0139]; Fig. 7);
Sarkar does not disclose setting the negative derivative filtered value to zero to obtain the derivative signal; and applying a slope sum filter to the derivative signal.
Su teaches signal processing for a cyclic respiratory signal to detect respiratory events to determine a disease state, using a rectified derivative filter followed by moving window integration of the rectified derivative signal in order to extract an envelope of the respiratory signal ([0069]; [Abstract]). Specifically for Claim 3, Su teaches applying a derivative filter to the filtered breathing signal and setting the negative derivative filtered value to zero to obtain the derivative signal ([0069] “… envelope extractor 90 may use other methods to generate the envelope signal, such as…rectifying the derivative of the signal…extract or generates the envelope signal of the processed signal…the band pass filtered, rectified, and smoothed signal…”)(Examiner notes that “rectifying” removes the negative portion of the signal, or sets it to zero.) and
applying a slope sum filter to the derivative signal ([0069] “…followed by moving window integration of the rectified derivative…”)(Examiner notes that a moving window integration performs a summation of the slopes within the window, and is broadly a slope sum filter.)
Su provides a motivation to combine at [0069] with “envelope extractor 90 may use other methods to generate the envelope signal, such as…rectifying the derivative of the signal followed by moving window integration of the rectified derivative. In such examples, envelope extractor 90 extracts or generates the envelope signal of the processed signal, i.e., the band pass filtered, rectified, and smoothed signal…” and [0036] with “Signal analyzer 46 may generate an envelope signal and apply an algorithm that uses an adaptively decaying threshold, to detect events within the envelope signal.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that extracting envelopes of the signal using a rectified derivative and moving window integration summation would be useful for isolating particular features of the signal in an “envelope” in which events can be identified.
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 combine the respiratory monitoring system for identifying respiratory rate including filtering and preprocessing the signal into intervals of interest disclosed in Sarkar with the rectified derivative and moving window integration of the rectified derivative signal taught by Su, creating a single respiratory monitoring system to smooth the signal and isolate particular features of the signal in an “envelope” in which events can be identified.
Su does not specifically recite a named slope sum filter.
Liu teaches peak detection in a cyclic signal using low pass filtering followed by a slope sum function to enhance the morphological upslope features ([Abstract]). Specifically for Claim 3, Liu teaches applying a slope sum filter to the preprocessed signal (Fig. 1, “Lowpass Filter”, “Slope Sum Function Calculation”; [Page 2, Left Column] including “The purpose of the slope sum function is to enhance the morphological upslope features of the pressure waveform and to suppress the remainder of the blood pressure signals…”)
Sarkar and Liu both disclose and teach cyclic signals with peaks/valleys that are desired for identification, along with upslopes and downslopes, Sarkar with respiratory impedance signals (Fig. 7), and Liu with cardiac pulse signals (Fig. 3). Liu provides a motivation to combine at [Page 1, Right Column, “II. Theory” Section] with “we compute the slope sum function to enhance the morphological upslope features of the pressure waveform and to suppress the remainder of the blood pressure signals, while it can greatly improve the computation efficiency of the mean shift algorithm in the next step.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a signal that has already been emphasized for the upslope using rectified derivative filtering, further using a slope sum function would also be helpful for this goal, “enhancing the morphological upslope features” of the waveform for more accurate isolation of signal features.
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 combine the respiratory monitoring system using a extracting envelopes of the signal using a rectified derivative and low-pass filtering preprocessing disclosed by Sarkar in view of Su disclosed in Sarkar with the slope sum function applied to preprocessed signal data, creating a single respiratory monitoring system to emphasize the upslope portion of the respiratory waveform for more accurate identification of signal features.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sarkar in view of Koh et. al., (US 7,223,244 B1).
Regarding Claim 5, Sarkar discloses as described above, The system of claim 4. For the remainder of Claim 5, Sarkar discloses the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3)
Sarkar does not specifically disclose determine a height difference between an inhalation and exhalation as a magnitude difference between the determined peak position and the neighboring determined valley position in the filtered breathing signal. Sarkar does broadly disclose determining the height of the peaks and the valleys for [0095] “…the peak-to-peak amplitude of the respiration waveform must be greater than a peak-to-peak threshold …”; Fig. 13 “maximum impedance value…” and Fig. 13 “minimum impedance value…”.
Koh teaches determination of tidal volume by subtracting the difference between peak and valley values in a measured cyclic respiratory signal. Specifically for Claim 5, Koh teaches determine a height difference between an inhalation and exhalation as a magnitude difference between the determined peak position and the neighboring determined valley position in the filtered breathing signal (Fig. 4, [Col 10, Lines 30 – 41] “the tidal volume is calculated as the difference between the peak and valley values…”)
Koh provides a motivation to combine at [Col 9, Lines 39 – 44] with “As is well known to those skilled in the art, the magnitude of the change of the impedance signal corresponds to the tidal volume and the frequency of change corresponds to respiration rate…”, and [Col 2, Lines 7 – 13] “The CO2 and respiration values are compared to each other (in one embodiment, by calculating a ratio of CO2 to TV), which provides an indication of a cardiac condition, such as a surrogate for heart failure progression and/or regression.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize having a tidal volume level would be useful in combination with other biological parameters (such as CO2 level) to diagnose cardiac conditions such as heart failure that have associated respiratory issues (such as reduced tidal volume).
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 combine the respiratory monitoring system for identifying respiratory rate including determining peaks and valleys in the respiratory signal disclosed in Sarkar with the calculation of tidal volume using the height difference between peaks and valleys taught by Koh, creating a single respiratory monitoring system that can be used to help diagnose respiratory conditions that affect tidal volume, or cardiac conditions such as heart failure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sarkar in view of Yuen et. al., (US 2010/0130873 A1).
Regarding Claim 7, Sarkar discloses as described above, The system of claim 6. For the remainder of Claim 7, Sarkar discloses wherein the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to determine the inhalation duration ([0061] “…inhale phases…”; Fig. 7; [0137]; [0043] “…impedance measurements may be conducted for a measurement duration…”; [0143] “…each respiratory cycle includes an inhale phase and an exhale phase.”; [0089] – [0090]) and the determined exhalation duration ([0061] “…exhale phases…”; Fig. 7; [0137]; [0043] “…impedance measurements may be conducted for a measurement duration…”; [0143] “…each respiratory cycle includes an inhale phase and an exhale phase.”; [0089] – [0090]).
Sarkar does not specifically disclose calculate an inhalation to exhalation ratio based on the determined inhalation duration and the determined exhalation duration.
Yuen teaches a physiological motion sensor for determining respiratory characteristics relative to detecting sleep apnea or other sleep disorders, with alert functionality based on calculation of an inhale time to exhale time ratio ([0188]; [Abstract]; [0117]; [0142]). Specifically for Claim 7, Yuen teaches calculate an inhalation to exhalation ratio based on the determined inhalation duration and the determined exhalation duration ([0142] “…variables extracted from the cardiopulmonary motion signal…variables include respiratory rate, inhale time, exhale time, inhale time to exhale time ratio…”; [0159]).
Yuen provides a motivation to combine at [0117] with “Various embodiments of the system 100 can provide alerts for…high inhale time to exhale time ratio, low inhale time to exhale time ratio, and changes in inhale time to exhale time ratio…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that calculating a specific inhale/exhale time ratio from an obtained inhale duration and exhale duration would be useful in creating alerts for breathing problems, such as when a high or low inhale time to exhale time ratio is detected, leading to better medical intervention for respiratory distress.
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 combine the respiratory monitoring system for identifying respiratory rate including determining inhale and exhale phase times disclosed in Sarkar with the calculation of an inhale/exhale time ratio taught by Yuen, creating a single respiratory monitoring system that can provide alerts when there are signs of respiratory distress such as a high or low inhale/exhale time ratio.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sarkar in view of Bolea et. al., (US 2008/0103407 A1).
Regarding Claim 11, Sarkar discloses as described above, The system of claim 10. For the remainder of Claim 11, Sarkar discloses the controller ([0114] “… Processing circuitry 50 may include…a controller…”; Fig. 3) is configured to determine a most recent valley position (Fig. 7), a breath interval based on lengths of previously selected breathing intervals (Fig. 7, [0006] “…identify the set of respiratory intervals”; [0032] “…Based on the mean respiratory interval…may calculate the respiration rate…”; [0097] – [0099] “…valid impedance measurements…”) and a phase delay caused by the low-pass filtering ([0031] “…the IMD may apply a high-pass filter and a low-pass filter to the impedance data.”)
Sarkar does not particularly disclose predict the timing of a start of a next inhalation based on a most recent valley position, a breath interval based on lengths of previously selected breathing intervals, and a phase delay caused by the low-pass filtering.
Bolea teaches a predictive algorithm for predicting the start of the next inspiration in cyclic respiratory data using previously-measured breathing intervals from cyclic respiratory data which was low-pass filtered (Fig. 48, Fig. 49; [0167] – [0172]; [0141]). Specifically for Claim 11, Bolea teaches the controller is configured to predict the timing of a start of a next inhalation based on a most recent valley position, a breath interval based on lengths of previously selected breathing intervals and a phase delay caused by the low-pass filtering ([0167] ‘…A self-adjusting predictive algorithm utilizes a reference datum to which the algorithm can be adjusted”; [0172] “…The Current Algorithm may use historic and/or real-time sensor fiducial variables to predict the next onset of inspiration. This predicted onset of inspiration may be referred to as Predicted Onset”; Fig. 48, Fig. 49; [0141] “…the signal processing step 374 may involve the use of a low pass filter (e.g., less than 1 Hz)…to remove cardiac frequency noise components…“; Fig. 40).
Bolea provides a motivation to combine at [00160] with “…data may be used to turn stimulus on (e.g., when apnea or hypopnea events start occurring or when motion artifact is absent)…” and [0161] with “…a predictive algorithm may be used to predict the inspiratory phase and deliver stimulation accordingly…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that determining a predicted inspiration time from respiratory data would be useful for potentially detecting apnea or applying treatment stimulation that is synchronized with the inhale portion of the respiratory cycle.
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 combine the respiratory monitoring system for identifying respiratory rate including determining inspiration and expiration phases and valleys in the respiratory signal disclosed in Sarkar with the prediction of an expected inspiration time using intervals of the respiratory cycle taught by Bolea, creating a single respiratory monitoring system that can predict the next inspiration time for potentially detecting apnea or applying treatment stimulation that is synchronized with the inhale portion of the respiratory cycle.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sarkar in view of Bolea et. al., (US 2008/0103407 A1), further in view of Yuen et. al., (US 2010/0130873 A1), further in view of Palley et. al., (US 2019/0167193 A1).
Regarding Claim 12, Sarkar in view of Bolea discloses as described above, The system of claim 11. For the remainder of Claim 12, Sarkar discloses wherein the controller is configured to determine the occurrence and/or severity of sleep apnea ([0142] “…patient conditions such as…sleep apnea… processing circuitry 14 may process the impedance data to determine one or more parameters (e.g., respiratory rate, respiratory rate variability… associated with respiratory cycles of the patient… analyze such parameters to identify or monitor one or more medical conditions.”)
Sarkar does not disclose based on a comparison between the predicted timing of the start of the next inhalation and an actual timing of the start of the next inhalation, and/or the calculated inhalation to exhalation ratio.
Yuen teaches calculated inhalation to exhalation ratio ([0142] “…variables extracted from the cardiopulmonary motion signal…variables include respiratory rate, inhale time, exhale time, inhale time to exhale time ratio…”; [0159]).
The motivation for Claim 12 to combine Sarkar with Yuen is the same as that described in more detail above for Claim 7. 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 combine the respiratory monitoring system for identifying respiratory rate including determining inhale and exhale phase times disclosed in Sarkar with the calculation of an inhale/exhale time ratio taught by Yuen, creating a single respiratory monitoring system that can provide alerts when there are signs of respiratory distress such as a high or low inhale/exhale time ratio.
Yuen does not specifically teach determine the occurrence and/or severity of sleep apnea based on a comparison between the predicted timing of the start of the next inhalation and an actual timing of the start of the next inhalation, and/or the calculated inhalation to exhalation ratio.
Palley teaches a system and method of monitoring respiration of a user, including using estimation of tidal volume as an indicator of apnea ([Abstract]; [0025]). Specifically for Claim 12, Palley teaches determine the occurrence and/or severity of sleep apnea based on a comparison between the predicted timing of the start of the next inhalation and an actual timing of the start of the next inhalation, and/or the calculated inhalation to exhalation ratio ([0025] “…The set of respiration characteristics characterized the set of respiration signals preferably comprises any one or more of…tidal volume (or an estimation thereof)… the set of respiration characteristics can indicate respiration events associated with…apnea…”)(Examiner notes that as described above, the ratio of the inhalation to exhalation is tidal volume.)
Palley provides a motivation to combine at [0025] with “…The set of respiration characteristics characterized the set of respiration signals preferably comprises any one or more of…tidal volume (or an estimation thereof)…the set of respiration characteristics can indicate respiration events associated with laughter, sighing, wheezing, coughing, apnea, and/or any other suitable event associated with the user’s respiration…”) A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that that tidal volume (ratio of inhalation to exhalation) is a useful metric for determining if apnea occurs.
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 combine the respiratory monitoring system for identifying respiratory rate including determining inspiration and expiration phases and a tidal volume disclosed by Sarkar in view of Yuan with the use of estimated tidal volume as an indicator of apnea taught by Palley, creating a single respiratory monitoring system that can determine evidence of apnea when there are signs of respiratory distress such as a high or low inhale/exhale time ratio (tidal volume).
Conclusion
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.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
