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 .
Reply to Response
The response filed May 15, 2026 has been entered. Applicant amended claims 1, 11, and 12. Examiner withdraws objections to claims 1 and 11. Claims 1-20 remain pending in the application.
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.
Step 1: Does the claimed invention fall inside one of the four statutory categories (process, machine, manufacture, or composition of matter)? Yes for claims 1-20. Claims 1-10 are drawn to a portable smart device for loop gain detection and breath training (i.e., a manufacture). Claims 11-20 are drawn to a method for loop gain detection and breath training (i.e., a process).
Step 2A - Prong One: Do the claims recite a judicial exception (an abstract idea enumerated in the 2019 PEG, a law of nature, or a natural phenomenon)? Yes, for claims 1-20.
Claim 1 recites:
A portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude sense;
and a processor configured to: perform a breath training session to determine breathing loop gain in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, determine a value of the loop gain based on the
These steps amount to a form of mental process and organizing human activity (i.e., an abstract idea) because a human can conduct a breath training session where a user is instructed to breathe in a specified manner, a human can collect physiological data (i.e., measurements that can monitor both the mental and physical status) of a user, and a human can calculate loop gain for a user. “One example of instructions for a sufferer to execute a sequence of forced breath holds is: Step 1: Breathe normally for 3 minutes. … Step 2: Breathe normally, then when prompted hold the breath after exhaling until the first clear urge to breathe is felt … Step 3: Breathe normally for approximately five minutes, until prompted to hold the breath after breathing out. … Step 4: From normal breathing, when prompted, gradually slow down until breathing is as slow as comfortable … Step 5: From slow breathing, exhale, hold the breath until a strong need to breathe is felt … Step 6: Repeat steps 3,4,5 … and Step 7: Breathe normally for 3 minutes to relax” [0054].
Independent claim 11 describes steps that are similar to steps of claim 1 (and therefore recite limitations that fall within this subject matter of grouping abstract ideas), and these claims are therefore determined to recite an abstract idea under the same analysis. Dependent claims 2-10 and 12-20 are directed towards mini-tasks (determining heart rate and blood oxygen saturation, tracking loop gain changes, classifying the user, etc.) for a portable smart device for loop gain detection and breath training. Each claim amounts to a form of collecting, generating, and analyzing information, and therefore falls within the scope of a method for organizing human activity, (i.e., an abstract idea). As such, the Examiner concludes that claims 2-10 and 12-20 recite an abstract idea.
Step 2A – Prong Two: Do the claims recite additional elements that integrate the exception into a practical application of the exception? No
In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
The requirement to execute the claimed steps/functions using a processor (independent claims 1 and 11 and dependent claims 2-10 and 12-20) is equivalent to adding the words “apply it” on a generic computer and/or mere instructions to implement the abstract idea on a generic computer.
Similarly, the limitations of processors (independent claims 1 and 11 and dependent claims 2-10 and 12-20) are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. These limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
Use of a computer, processor, memory 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 integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015) (See MPEP 2106.05(f)).
Further, the additional limitations beyond the abstract idea identified above, serve merely to generally link the use of the judicial exception to a particular technological environment or field of use. Specifically, they serve to limit the application of the abstract idea to a computerized environment (e.g., identifying and displaying, etc.) performed by a computing device, processor, and memory, etc. This reasoning was demonstrated in Intellectual Ventures I LLC v. Capital One Bank (Fed. Cir. 2015), where the court determined "an abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment, such as the Internet [or] a computer"). These limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(h)).
Dependent claims 2-10 and 12-20 fail to include any additional elements. In other words, each of the limitations/elements recited in respective dependent claims are further part of the abstract idea as identified by the Examiner for each respective independent claim (i.e., they are part of the abstract idea recited in each respective claim). The Examiner has therefore determined that the additional elements, or combination of additional elements, do not integrate the abstract idea into a practical application. Accordingly, the claims are directed to an abstract idea.
Step 2B: Does the claim as a whole amount to significantly more than the judicial exception? i.e., Are there any additional elements (features/limitations/step) recited in the claim beyond the abstract idea? No
In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, are sufficient to ensure that the claims amount to significantly more than the judicial exception. This analysis is also termed a search for an “inventive concept.” An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amount to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
As discussed above in “Step 2A – Prong Two”, the identified additional elements in independent claims 1 and 11 and dependent claims 2-10 and 12-20 are equivalent to adding the words “apply it” on a generic computer, and/or generally link the use of the judicial exception to a particular technological environment or field of use. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself.
Viewing the additional limitations in combination also shows that they fail to ensure the claims amount to significantly more than the abstract idea. When considered as an ordered combination, the additional components of the claims add nothing that is not already present when considered separately, and thus simply append the abstract idea with words equivalent to “apply it” on a generic computer and/or mere instructions to implement the abstract idea on a generic computer or/and append the abstract idea with insignificant extra solution activity associated with the implementation of the judicial exception, (e.g., mere data gathering, post-solution activity) and/or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Dependent claims 2-10 and 12-20 fail to include any additional elements. In other words, each of the limitations/elements recited in respective independent claims are further part of the abstract idea as identified by the Examiner for each respective dependent claim (i.e. they are part of the abstract idea recited in each respective claim). The Examiner has therefore determined that no additional element, or combination of additional claims elements are sufficient to ensure the claims amount to significantly more than the abstract idea identified above. Therefore, claims 1-20 are not eligible subject matter under 35 USC 101.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being unpatentable under US 20230337937 A1 (“Barlow”) in view of US 20210213001 A1 (“Cooke”).
In regards to claim 1, Barlow discloses the following limitations with the exception of the underlined limitations.
A portable ([0114], “the present technology is a portable ... device”) smart device, comprising ([0364], “the ... system ... may comprise features considered to be “smart” features, such as the ability to interact with the user”): a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude ([0417], “the oxygen saturation sensor … may comprise a photoplethysmogram (PPG) sensor” Examiner notes that a PPG sensor can detect volumetric blood changes and can generate pulse amplitude data.);
and a processor coupled to the sensor, the processor configured to ([0367], “the … system … comprises a processor”): perform a breath training session to ([0568], “the … system … may be configured to operate in a breath training mode”) determine breathing loop gain in an awake state ([0078], “the … system is configured to detect that the user is awake”) by instructing the user to perform a breath-hold while in an awake state ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”), receive physiological data from the sensor ([0368], “The processor … may … interface with the communication module … to send and receive data to … sensors”) during a recovery phase following the breath-hold ([0506], “the … system … is configured to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”), automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase ([0433], “The … system … may be configured to detect … pulse”), determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain , generate tailored breath training exercises ([0507], “the … system … may be configured to monitor the user’s breathing during breath training”), specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain deliver the tailored breath training exercises to the user via the portable smart device ([0506], “the … system … may be configured to operate in a breath training mode”), and track changes in the loop gain over time across multiple breath training sessions and modify the tailored breath training exercises based on the tracked changes ([0510], “the … system … is configured to be used to assist/encourage sleep in the breath training mode … the … system … is configured to be used for relaxation or meditation while the user is awake … the breath training mode may be used for anti-anxiety purposes or to provide a calming effect.)
Cooke discloses
determine breathing loop gain ([0152], “In some embodiments, the subject is tested for … loop gain”)
determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user ( [0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”), identify the user as having a high loop gain based on the determined value of the loop gain ([0049], “The epoch of periodic breathing illustrated … the average value of loop gain across the epoch was 1.71”)
specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”)
and track changes in the loop gain over time across multiple breath training sessions ([0152], “In some embodiments, the subject is tested for elevated loop gain prior to or following administration of a KCNQ potassium channel opener.”)
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 2, Barlow discloses
wherein the sensor is at least one of a heart rate sensor or a blood oxygen saturation sensor ([0095], “the … transducers may comprise … a heart rate sensor; … an oxygen saturation sensor”).
In regards to claim 3, Barlow discloses the following limitation with the exception of the underlined limitation.
wherein the processor is further configured to guide the breath training session by instructing the user to breathe in a specified manner by performing breath holds and rhythmic breathing patterns intended to ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”) reduce the loop gain.
Cooke discloses
reduce the loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”)
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, wherein the processor is further configured to guide the breath training session by instructing the user to breathe in a specified manner by performing breath holds and rhythmic breathing patterns intended to, as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, reduce the loop gain, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 4, Barlow discloses the following limitation with the exception of the underlined limitation.
wherein the processor is further configured to track changes in ([0368], “Actions described herein as being steps performed by the … system … (such as actions, determinations, identifications, comparisons, optimisations, operations, among others) are to be understood to be steps performed in … by a processor”) the loop gain over time.
Cooke discloses
the loop gain over time ([0152], “In some embodiments, the subject is tested for elevated loop gain prior to or following administration of a KCNQ potassium channel opener.”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, wherein the processor is further configured to track changes in, as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, the loop gain over time, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 5, Barlow discloses the following limitation with the exception of the underlined limitation.
wherein the processor is further configured to ([0368], “Actions described herein as being steps performed by the … system … (such as actions, determinations, identifications, comparisons, optimisations, operations, among others) are to be understood to be steps performed in … by a processor”) determine a value of the loop gain based on a phenotype classification of the user.
Cooke discloses
determine a value of the loop gain based on a phenotype classification of the user ([0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 6, Barlow discloses
wherein the sensor is integrated directly into the portable smart device ([0067], “the … system may comprise an ECG sensor; … a heart rate sensor; … an oxygen saturation sensor; … a blood pressure sensor” Examiner notes that comprise can mean directly integrated into.).
In regards to claim 7, Barlow discloses
wherein the sensor is external to and in communication with the portable smart device ([0233], “External transducers may be in the form of non- contact sensors such as a Doppler radar movement sensor that transmit or transfer data”).
In regards to claim 8, Barlow discloses the following limitations with the exception of the underlined limitation.
wherein the processor is further configured to ([0367], “the … system … comprises a processor”) instruct the user to perform breathing exercises for the ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”) determination of the loop gain.
Cooke discloses
determination of the loop gain ([0152], “In some embodiments, the subject is tested for … loop gain”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, wherein the processor is further configured to instruct the user to perform breathing exercises for the, as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, determination of the loop gain, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 9, Barlow discloses the following limitation with the exception of the underlined limitation.
wherein the processor is further configured to ([0367], “the … system … comprises a processor”) perform a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data.
Cooke discloses
perform a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data ([0049], “The epoch of periodic breathing illustrated … the average value of loop gain across the epoch was 1.71”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, wherein the processor is further configured to, as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, perform a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 10, Barlow discloses the following limitations with the exception of the underlined limitations.
wherein the processor is further configured to ([0367], “the … system … comprises a processor”) tailor breath training exercises specifically to ([0568], “the … system … may be configured to operate in a breath training mode”) reduce the high loop gain, the tailoring based on the classification of the user and the determined value of the loop gain.
Cooke discloses
reduce the high loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”),
the tailoring based on the classification of the user and the determined value of the loop gain ([0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”)
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a portable smart device, comprising: a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; and a processor coupled to the sensor, the processor configured to: perform a breath training session to in an awake state by instructing the user to perform a breath-hold while in an awake state, receive physiological data from the sensor during a recovery phase following the breath-hold, automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generate tailored breath training exercises deliver the tailored breath training exercises to the user via the portable smart device and modify the tailored breath training exercises based on the tracked changes, wherein the processor is further configured to tailor breath training exercises specifically to as disclosed by Barlow, determine breathing loop gain, determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identify the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and track changes in the loop gain over time across multiple breath training sessions, reduce the high loop gain, the tailoring based on the classification of the user and the determined value of the loop gain, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 11, Barlow discloses the following limitations with the exception of the underlined limitations.
A method for determining breathing loop gain in an awake state ([0078], “the … system is configured to detect that the user is awake”) using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device ([0095], “the ... transducers may comprise ... a heart rate sensor ... a blood pressure sensor ... a temperature sensor” Examiner notes that physiological parameters include heart rate, blood pressure, and temperature.) volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude ([0417], “the oxygen saturation sensor … may comprise a photoplethysmogram (PPG) sensor” Examiner notes that a PPG sensor can detect volumetric blood changes and can generate pulse amplitude data.);
instructing the user to perform a breath-hold while in an awake state ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”);
receiving physiological data from the sensor ([0368], “The processor … may … interface with the communication module … to send and receive data to … sensors”) during a recovery phase following the breath-hold ([0506], “the … system … is configured to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”);
automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase ([0433], “The … system … may be configured to detect … pulse”);
determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user;
identifying the user as having a high loop gain based on the determined value of the loop gain;
generating tailored breath training exercises ([0507], “the … system … may be configured to monitor the user’s breathing during breath training”) specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain;
delivering the tailored breath training exercises to the user via the portable smart device ([0506], “the … system … may be configured to operate in a breath training mode”);
and tracking changes in the loop gain over time across multiple breath training sessions and modifying the tailored breath training exercises based on the tracked changes ([0510], “the … system … is configured to be used to assist/encourage sleep in the breath training mode … the … system … is configured to be used for relaxation or meditation while the user is awake … the breath training mode may be used for anti-anxiety purposes or to provide a calming effect.).
Cooke discloses
determining breathing loop gain ([0152], “In some embodiments, the subject is tested for … loop gain”)
determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user ( [0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”), identifying the user as having a high loop gain based on the determined value of the loop gain ([0049], “The epoch of periodic breathing illustrated … the average value of loop gain across the epoch was 1.71”)
specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”)
and tracking changes in the loop gain over time across multiple breath training sessions ([0152], “In some embodiments, the subject is tested for elevated loop gain prior to or following administration of a KCNQ potassium channel opener.”)
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 12, Barlow discloses
wherein the sensing optically detecting step involves using at least one of a heart rate sensor or a blood oxygen saturation sensor ([0095], “the … transducers may comprise … a heart rate sensor; … an oxygen saturation sensor”).
In regards to claim 13, Barlow discloses the following limitations with the exception of the underlined limitations.
further comprising guiding the breath training session by instructing the user to breathe in a specified manner by performing breath holds and rhythmic breathing patterns intended to ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”) reduce the loop gain.
Cooke discloses
reduce the loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”)
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, further comprising guiding the breath training session by instructing the user to breathe in a specified manner by performing breath holds and rhythmic breathing patterns intended to, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, reduce the loop gain, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 14, Barlow does not disclose further comprising tracking changes in the loop gain over time.
Cooke discloses
further comprising tracking changes in the loop gain over time ([0152], “In some embodiments, the subject is tested for elevated loop gain prior to or following administration of a KCNQ potassium channel opener.”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, further comprising tracking changes in the loop gain over time, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 15, Barlow does not disclose further comprising determining a value of the loop gain based on a phenotype classification of the user.
Cooke discloses
further comprising determining a value of the loop gain based on a phenotype classification of the user ([0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, further comprising determining a value of the loop gain based on a phenotype classification of the user, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 16, Barlow discloses
wherein the sensor is integrated directly into the portable smart device ([0067], “the … system may comprise an ECG sensor; … a heart rate sensor; … an oxygen saturation sensor; … a blood pressure sensor” Examiner notes that comprise can mean directly integrated into.).
In regards to claim 17, Barlow discloses
wherein the sensor is external to and in communication with the portable smart device ([0233], “External transducers may be in the form of non- contact sensors such as a Doppler radar movement sensor that transmit or transfer data”).
In regards to claim 18, Barlow discloses the following limitation with the exception of the underlined limitation.
further comprising instructing the user to perform breathing exercises for the ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”) determination of the loop gain.
Cooke discloses
determination of the loop gain ([0152], “In some embodiments, the subject is tested for … loop gain”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, further comprising instructing the user to perform breathing exercises, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, determination of the loop gain, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 19, Barlow does not disclose further comprising performing a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data.
Cooke discloses
further comprising performing a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data ([0049], “The epoch of periodic breathing illustrated … the average value of loop gain across the epoch was 1.71”).
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, further comprising performing a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
In regards to claim 20, Barlow discloses the following limitation with the exception of the underlined limitation.
further comprising tailoring breath training exercises specifically to ([0568], “the … system … may be configured to operate in a breath training mode”) reduce the high loop gain, the tailoring based on the classification of the user and the determined value of the loop gain.
Cooke discloses
reduce the high loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”),
the tailoring based on the classification of the user and the determined value of the loop gain ([0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”)
Barlow and Cooke are considered analogous to the claimed invention because they are in the fields of respiratory-related disorders and sleep breathing disorder treatments. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a method for in an awake state using a portable smart device, the method comprising: optically detecting, with a sensor coupled to the portable smart device volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude; instructing the user to perform a breath-hold while in an awake state; receiving physiological data from the sensor during a recovery phase following the breath-hold; automatically analyzing, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase, generating tailored breath training exercises; delivering the tailored breath training exercises to the user via the portable smart device; and modifying the tailored breath training exercises based on the tracked changes, further comprising tailoring breath training exercises specifically to, as disclosed by Barlow, determining breathing loop gain, determining a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user, identifying the user as having a high loop gain based on the determined value of the loop gain specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain and tracking changes in the loop gain over time across multiple breath training sessions, further comprising performing a classification by classifying the user as having a high loop gain based on the determined value of the loop gain and previously determined physiological data, reduce the high loop gain, the tailoring based on the classification of the user and the determined value of the loop gain, as disclosed by Cooke, to provide loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea. One skilled in the art would understand and recognize the value of the addition of loop gain, a sleep breathing disorder treatment, and a KCNQ potassium channel opener for a method that treats or prevents sleep apnea.
Response to Remarks
Applicant's arguments filed May 15, 2026 have been fully considered but are not persuasive. Applicant amended claims 1, 11, and 12. Claims 1-20 remain pending in the application. With respect to claim rejections under 35 U.S.C. 101, Applicant states “The amended claims include limitations that cannot practically be performed in the human mind, including a sensor that optically detects volumetric changes in blood of a user to generate physiological data indicative of pulse interbeat interval or pulse amplitude, and a processor that automatically analyzes recovery characteristics of the pulse interbeat interval or pulse amplitude during the recovery phase following a breath-hold.” (See RESPONSE, Remarks, § 101 Rejection, page 7, paragraph 3.) and “the claims are eligible under Step 2A Prong 2 because the alleged abstract idea is integrated into a practical application” (See RESPONSE, Remarks, § 101 Rejection, page 9, paragraph 4.) Examiner acknowledges Applicant’s remarks. Regarding the claims, the limitations of the claims amount to an abstract idea, which includes a form of mental process and organizing human activity because a human can conduct a breath training session where a user is instructed to breathe in a specified manner, a human can collect physiological data (i.e., measurements that can monitor both the mental and physical status) of a user, and a human can calculate loop gain for a user. The claimed invention includes steps or a procedure for providing a breath training session. Examiner notes that steps are individual, sequential actions that make up a procedure. The Supreme Court has identified a number of concepts falling within this grouping as abstract ideas including: a procedure for converting binary-coded decimal numerals into pure binary form, Gottschalk v. Benson, 409 U.S. 63, 65, 175 USPQ2d 673, 674 (1972); a mathematical formula for calculating an alarm limit, Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ2d 193, 195 (1978); the Arrhenius equation, Diamond v. Diehr, 450 U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ 2d 1001, 1004 (2010). Dependent claims 2-10 and 12-20 are directed towards mini-tasks (determining heart rate and blood oxygen saturation, tracking loop gain changes, classifying the user, etc.) for a portable smart device for loop gain detection and breath training. Each claim amounts to a form of collecting, generating, and analyzing information, and therefore falls within the scope of a method for organizing human activity, (i.e., an abstract idea). As such, the Examiner concludes that claims 2-10 and 12-20 recite an abstract idea.
Furthermore, the requirement to execute the steps using a processor of the claimed invention is equivalent to adding the words “apply it” on a computer and/or instructions to implement the abstract idea on a computer. The limitations of the processor system amount to no more than instructions to apply the exception using computer components. These limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)) or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015) (See MPEP 2106.05(f)).
In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is sufficient to ensure that the claims amount to significantly more than the judicial exception. This analysis is also termed a search for an “inventive concept.” An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amount to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Examiner notes that a sensor that optically detects volumetric blood changes and a processor that analyzes pulse amplitude recovery characteristics are not inventive concepts. The identified additional elements in independent claims 1 and 11 and dependent claims 2-10 and 12-20 are equivalent to adding the words “apply it” on a generic computer, and/or generally link the use of the judicial exception to a particular technological environment or field of use. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself. The Examiner has determined that no additional element or combination of additional elements is sufficient to ensure the claims amount to significantly more than the abstract idea identified above. Therefore, claims 1-20 are not eligible subject matter under 35 USC 101.
With respect to § 102 Rejection over Barlow, Applicant states, “Claim 1 recites, among other features, ‘automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase’ and ‘determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user.’ Barlow fails to disclose these features.” (See RESPONSE, Remarks, § 102 Rejection over Barlow, page 11, paragraphs 2-3.) Examiner acknowledges Applicant’s remarks. Regarding claim 1, Barlow discloses a portable ([0114], “the present technology is a portable ... device”) smart device, comprising ([0364], “the ... system ... may comprise features considered to be “smart” features, such as the ability to interact with the user”): a sensor coupled to the portable smart device, the sensor configured to optically detect volumetric changes in blood of a user to generate physiological data indicative of at least one of pulse interbeat interval or pulse amplitude ([0417], “the oxygen saturation sensor … may comprise a photoplethysmogram (PPG) sensor” Examiner notes that a PPG sensor can detect volumetric blood changes and can generate pulse amplitude data.); and a processor coupled to the sensor, the processor configured to ([0367], “the … system … comprises a processor”): perform a breath training session to ([0568], “the … system … may be configured to operate in a breath training mode”) in an awake state ([0078], “the … system is configured to detect that the user is awake”) by instructing the user to perform a breath-hold while in an awake state ([0506], “the … system … may be configured to operate in a breath training mode … to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”), receive physiological data from the sensor ([0368], “The processor … may … interface with the communication module … to send and receive data to … sensors”) during a recovery phase following the breath-hold ([0506], “the … system … is configured to assist the user to breathe in a manner conducive to relaxation, meditation, sleeping or the like”), automatically analyze, from the received physiological data, recovery characteristics of at least one of pulse interbeat interval or pulse amplitude during the recovery phase ([0433], “The … system … may be configured to detect … pulse”), generate tailored breath training exercises ([0507], “the … system … may be configured to monitor the user’s breathing during breath training”), deliver the tailored breath training exercises to the user via the portable smart device ([0506], “the … system … may be configured to operate in a breath training mode”), and modify the tailored breath training exercises based on the tracked changes ([0510], “the … system … is configured to be used to assist/encourage sleep in the breath training mode … the … system … is configured to be used for relaxation or meditation while the user is awake … the breath training mode may be used for anti-anxiety purposes or to provide a calming effect.) and Cooke discloses determine breathing loop gain ([0152], “In some embodiments, the subject is tested for … loop gain”), determine a value of the loop gain based on the analyzed recovery characteristics and a phenotype classification of the user ( [0153], “effectiveness of a sleep breathing disorder treatment … may be assessed by testing for reduced loop gain”), identify the user as having a high loop gain based on the determined value of the loop gain ([0049], “The epoch of periodic breathing illustrated … the average value of loop gain across the epoch was 1.71”)
specifically designed to reduce the high loop gain based on the identification of the user as having the high loop gain and the determined value of the loop gain ([0053], “The average value of loop gain across this epoch of period breathing was 1.16.”)
and track changes in the loop gain over time across multiple breath training sessions ([0152], “In some embodiments, the subject is tested for elevated loop gain prior to or following administration of a KCNQ potassium channel opener.”).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, independent claims 1 and 11, as obvious over Barlow in view of Cooke, are rejected. Furthermore, dependent claims 2-10 and 12-20, as obvious over Barlow in view of Cooke, are rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Antoine whose telephone number is (571)272-4252. The examiner can normally be reached Monday - Thursday 8:30 am - 6:30 pm EST.
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, Xuan Thai can be reached at (571) 272-7147. 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. 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.
LISA H ANTOINE
Examiner
Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
Prosecution Insights