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 .
Status of the Claims
The office action is in response to the claims filed on February 24, 2023 for the application filed on February 24, 2023, which is a U.S. National Stage of International Application No. PCT/US2021/048459 filed on August 31, 2021, which claims the benefit of U.S. Provisional Application Serial No. 63/072,467 filed August 31, 2020. Claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 are currently pending and have been examined as discussed below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1– 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 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.
Eligibility Step 1:
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim as a whole falls within one of the statutory categories of invention (i.e., a process, machine, manufacture, or composition of matter). See MPEP 2106.03. In the instant application, claims 1– 5, 9, 11 – 14, 16 – 18, 21, and 30 are directed to a method (i.e., a process); and claims 35 – 44 are directed to a system (i.e., a machine).
While each one of claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 appears to fall within one or more statutory categories of invention, the Office has determined that the full eligibility analysis is required because there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself. The eligibility of each claim is not self-evident at least because each claim as a whole did not appear to clearly improve a technology or computer functionality. To the contrary, each claim as a whole appeared to merely apply one or more judicial exceptions on a computer.
Accordingly, it has been determined that each one of claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 28, 35, 37, and 39 – 44 as a whole falls within one or more statutory categories under Step 1, and the Office proceeds with the full eligibility analysis (the Alice/Mayo test described in MPEP 2106(III)) as discussed below.
Eligibility Step 2A, Prong One:
Under Step 2A, Prong One of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim is directed to one or more of the judicial exceptions (i.e., an abstract idea, law of nature, or natural phenomenon). See MPEP 2106.04(II)(A)(1). After evaluation, it has been determined that claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 are directed to judicial exceptions because claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 recite abstract ideas. (The Office will not determine that a claim is not directed to a judicial exception under Step 2A, Prong One for the mere reason that claim further recites one or more additional elements beyond the judicial exception.)
The abstract idea exception includes three groupings: (i) mathematical concepts, (ii) certain methods of organizing human activities (“CMOHA”), and (iii) mental processes. See MPEP 2106.04(a). The CMOHA grouping includes three sub-groupings: (i) "fundamental economic practices" or "fundamental economic principles," (ii) "commercial interactions" or "legal interactions"; and (iii) "managing personal behavior or relationships or interactions between people." See MPEP 2106.04(a). The sub-grouping "managing personal behavior or relationships or interactions between people" includes social activities, teaching, and following rules or instructions. See MPEP 2106.04(a)(2)(II)(C). The "mental processes" grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. See MPEP 2106.04(a)(2)(III). The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). Claims can recite a mental process even if they are claimed as being performed on a computer. See MPEP 2106.04(a)(2)(III)(c).
Claims 1 and 35 are determined to be directed to a judicial exception including abstract ideas (i.e., mental process and/or CMOHA). Representative claim 35 recites the mental process identified in bold as:
A system for determining a breathing habit of a user, comprising:
a substrate configured to be coupled to nostrils of the user, the substrate comprising:
a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate;
a memory storing machine-readable instructions; and
a control system integrated in the substrate, the control system including one or more processors configured to execute the machine-readable instructions to:
determine, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user;
responsive to the determination that the substrate is coupled to the nostrils of the user, turn on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor;
receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user;
analyze the received data to determine, a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing through the nostrils of the user;
determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses; and
based at least in part on a result of the analysis, cause a mask recommendation to be communicated to the user.
Claims 1 and 35 recite an the abstract ideas identified in bold as “determining a breathing habit of a user,” “determine … that the substrate is coupled to the nostrils of the user,” and “analyze the received data to determine, … for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing through the nostrils of the user.” At best, these limitations in combination amount to the activity of determining a mask recommendation, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion. Furthermore, the limitations in combination with computer components (i.e., the system, the substrate, the memory, the control system, the one or more processors, the motion sensor, the moisture sensor, the temperature sensor, the pressure sensor, the flow rate sensor, etc.) still amount to an abstract idea (i.e., determining a mask recommendation) because no distinction should be made between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). With the exception of generic computer-implemented steps, there is nothing in claims 1 and 35 themselves that foreclose them from being performed by a human, mentally or with tools such as pen and paper. The limitation is directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform conventional computer processes. See MPEP 2106.04(a)(2)(III)(C)(3). Thus, this activity is an abstract idea in the "mental process" grouping.
Accordingly, claim 1 and 35 are directed to judicial exceptions under Step 2A, Prong One.
Dependent claims 2 – 5, 9, 11 – 14, 16 – 18, 21, 37, and 39 – 44 are directed to one or more judicial exceptions (i.e., abstract idea exceptions) under Step 2A, Prong One of the full eligibility analysis as follows:
The limitations of “the selected timeframe is at least about 90 percent of the sleep session” in claim 2, “the selected timeframe is a total period of time during the sleep session that the user is asleep” in claim 3, and “a duration of the selected timeframe is adjusted based at least in part on an apnea hypopnea index (AHi) value for the user” in claim 4, “the mask recommendation indicates a breathing habit of the user, the breathing habit of the user being one of a mouth-breathing habit or a nose-breathing habit” in claim 5, “determining a nose-breathing percent for the selected timeframe indicating a percentage of the selected timeframe that the user breathed through the nostrils,” “determining that the user is a nose-breather based at least in part on the nose-breathing percent for the selected timeframe exceeding a threshold,” and “determining that the user is a mouth-breather based at least in part on the nose-breathing percent for the percent of time being below the threshold” in claim 9, “determining, from the received data, a breathing pattern of the user, wherein the breathing pattern includes (a) inhaling through the nostrils, inhaling through a mouth of the user, or both, and (b) exhaling through the nostrils, exhaling through the mouth, or both” and “the mask recommendation indicates the breathing pattern of the user” in claim 11, “the breathing pattern is determined to include inhaling through the nostrils followed by exhaling through the nostrils based at least in part on the received data indicating a change in airflow direction through the nostrils” in claim 12, “the breathing pattern is determined to include (i) inhaling through the nostrils followed by exhaling through the mouth, (ii) exhaling through the nostrils followed by inhaling through the mouth, (iii) inhaling through the mouth followed by exhaling through the nostrils, or (iv) exhaling through the mouth followed by inhaling through the nostrils, based at least in part on determining consecutive inhalations without expirations or consecutive expirations without inhalations through the nostrils” in claim 13, and “the breathing pattern is determined to include inhaling through both the nostrils and the mouth or exhaling through both the nostrils and the mouth based at least in part on a pressure level around the nostrils being below a threshold” in claim 14, “determining, from the received data, one or more sleeping positions of the user during the sleep session, the sleeping position including a supine sleep position, prone sleep position, left side sleep position, right side sleep position, a sleep position where a head of the user is elevated, or any combination thereof” and “determining, for each sleeping position, a corresponding breathing habit of the user” in claim 16, “the mask recommendation further indicates a recommended sleeping position of the user as any of the sleeping positions where the corresponding breathing habit of the user is a nose-breathing habit” in claim 17, “causing an instruction to perform at least one in-and-out breath pair to be communicated to the user, wherein the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils” in claim 18, “determining, from the received data, a congestion level of the user, wherein the mask recommendation further indicates that data from a subsequent sleep session is required based at least in part on the congestion level being above a congestion threshold” in claim 21, “the data is received from a substrate coupled to the nostrils of the user, and the mask recommendation to be communicated to the user is further communicated via is a visual signal including a light that is provided on the substrate” in claim 28, “the membrane is configured to measure a pressure associated with the user breathing” in claim 37, “the membrane is configured to determine whether the user is breathing through both nostrils or through one” in claim 39, “the membrane is configured to measure a flow rate of air through the nostrils of the user” in claim 40, “the mask recommendation includes a visual signal, an auditory signal, a tactile signal, or a combination thereof” in claim 41, “the substrate includes a light for providing the visual signal” in claim 42, “the substrate includes one or more additional sensors including a pressure sensor, a flow rate sensor, a tempera-tum sensor, an acoustic sensor, an infrared sensor, a camera, a force sensor, a capacitive sensor, a piezoresistive sensor, a moisture sensor, an oxygen sensor, or any combination thereof” in claim 43, and “the substrate is coupled to an external device including a mobile phone associated with the user, a smart speaker associated with the user, a desktop computer associated with the user, a laptop computer associated with the user, or any combination thereof” in claim 44, individually or in ordered combination, further define the activity of determining a mask recommendation, which can be practically performed in the human mind using observation, evaluation, judgment, and opinion. Furthermore, these limitations in combination with computer components (i.e., the system, the substrate, the memory, the control system, the one or more processors, the motion sensor, the moisture sensor, the temperature sensor, the pressure sensor, the flow rate sensor, etc.) still amount to an abstract idea because no distinction should be made between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). With the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with tools such as pen and paper. The limitations are directed to the mental process of parsing and comparing data, because the steps were recited at a high level of generality and merely used computer components as a tool to perform conventional computer processes. See MPEP 2106.04(a)(2)(III)(C)(3). Thus, this activity is an abstract idea in the "mental process" grouping.
Therefore, for at least these reasons, claims 2 – 5, 9, 11 – 14, 16 – 18, 21, 37, and 39 – 44 recite judicial exceptions under Step 2A, Prong One.
Eligibility Step 2A, Prong Two:
Under Step 2A, Prong Two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claims recite any additional limitations individually or in combination that integrate a judicial exception (i.e., the identified abstract ideas) into a practical application. After evaluation, it has been determined that claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 do not recite any additional elements individually or in combination that integrate the abstract ideas into a practical application.
Regarding claims 1 and 35, representative claim 35 recites the additional limitations identified in bold as:
A system for determining a breathing habit of a user, comprising:
a substrate configured to be coupled to nostrils of the user, the substrate comprising:
a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate;
a memory storing machine-readable instructions; and
a control system integrated in the substrate, the control system including one or more processors configured to execute the machine-readable instructions to:
determine, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user;
responsive to the determination that the substrate is coupled to the nostrils of the user, turn on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor;
receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user;
analyze the received data to determine, a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing through the nostrils of the user;
determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses; and
based at least in part on a result of the analysis, cause a mask recommendation to be communicated to the user.
Regarding the consideration under MPEP 2106.04(d)(2), the claim as a whole does not amount to a particular treatment or prophylaxis, but rather merely amount to instructions to “apply” the abstract idea in a generic way. Thus, each one of the claims as whole does not integrate the exception into a practical application.
Regarding the consideration under MPEP 2106.05(a), claims 1 and 35 recite the additional limitations identified in bold as “a system,” “a substrate configured to be coupled to nostrils of the user,” “a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate,” “a memory storing machine-readable instructions,” “a control system including one or more processors configured to execute the machine-readable instructions,” “at least one of the motion sensor, the moisture sensor, or the temperature sensor,” “responsive to the determination that the substrate is coupled to the nostrils of the user, turn on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor,” “receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user,” and “, a respiration signal associated with the user.” These limitations do not “purport to improve the functioning of the computer itself" or "any other technology or technical field.” The claims merely include mere instructions to perform the method on a generic component or machinery. Even assuming if the claims provide an improvement (which the Office does not agree), the claims provide an improvement in the abstract idea itself (i.e., determining a mask recommendation), and thus is not an improvement in technology. See MPEP 2106.05(a)(II). Thus, it is determined that each one of the claims as a whole and the additional elements, individually or in ordered combination, fail to integrate the abstract ideas into a practical.
Regarding the consideration under MPEP 2106.05(b), the claims merely add generic computer components (i.e., the system, the substrate, the memory, the control system, the one or more processors, the motion sensor, the moisture sensor, the temperature sensor, the pressure sensor, the flow rate sensor, etc.) to perform conventional computer functions. It is important to note that a general purpose computer or generic computer components that apply a judicial exception, such as an abstract idea, by use of conventional computer functions do not qualify as a particular machine. See MPEP 2106.05(b)(1). Thus, each one of the claims as whole does not integrate the exception into a practical application.
Regarding the consideration under MPEP 2106.05(f), each one of the additional limitations in bold above is determined to be mere instructions to apply an abstract idea. These limitations are used to implement the abstract ideas recited at a high level of generality and are determined to be no more than mere instructions to implement the abstract ideas (i.e., the mental process of determining a mask recommendation) on generic computer components including the system, the substrate, the memory, the control system, the one or more processors, the motion sensor, the moisture sensor, the temperature sensor, the pressure sensor, the flow rate sensor, etc.. Accordingly, for these additional reasons, each one of claims 1 and 35 as a whole and the additional limitations, individually or in ordered combination, do not integrate the abstract idea into a practical application.
Regarding the consideration under MPEP 2106.05(g), the additional limitation in bold as “receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user” is determined to not add more than insignificant extra-solution activity to the judicial exception. This limitation is a well-known pre-solution activity of necessary data gathering incidental to the primary process of determining a mask recommendation. Accordingly, for these additional reasons, each one of claims 1 and 35 as a whole and the additional limitations, individually or in combination, do not integrate the abstract idea into a practical application.
Regarding the consideration under MPEP 2106.05(h), the additional limitations, individually or in combination, also amount to merely indicating a field of use or technological environment in which to apply the judicial exception. In the instant application, the additional limitations of the system, the substrate, the memory, the control system, the one or more processors, the motion sensor, the moisture sensor, the temperature sensor, the pressure sensor, the flow rate sensor, etc. do no more than link the abstract idea (i.e., the mental process of determining a mask recommendation) to a particular technological environment, i.e., the field of respiratory therapy systems (as opposed to any other computer-aided diagnosis). Thus, the additional limitations fail to add an inventive concept to the claims.
Accordingly, in view of these considerations, the Office has determined each one of claims 1 and 35 as a whole and the additional limitations, individually or in combination, fail to integrate the abstract idea exception into a practical application under Step 2A, Prong Two.
Dependent claims 2 – 5, 9, 11 – 14, 16 – 18, 21, 37, and 39 – 44 present additional information in tandem with further details regarding elements from an associated one of independent claims 1 and 35 and are therefore directed to one or more abstract ideas for similar reasons as given under Step 2A, Prong One above. Claims 18, 37, and 39 – 44 further recite additional limitations, and these additional limitations fail to integrate the abstract idea into a practical application under Step 2A, Prong Two.
Regarding the consideration under MPEP 2106.04(d)(2), the claim as a whole does not amount to a particular treatment or prophylaxis, but rather merely amount to instructions to “apply” the abstract idea in a generic way. Thus, each one of the claims 18 and 36 – 44 as whole does not integrate the exception into a practical application.
Regarding the consideration under MPEP 2106.05(a), the additional limitations identified in bold as “receiving data associated with the at least one in-and-out breath pair” in claim 18, “the membrane is configured to measure a pressure associated with the user breathing” in claim 37, “the membrane is configured to determine whether the user is breathing through both nostrils or through one” in claim 39, “the membrane is configured to measure a flow rate of air through the nostrils of the user” in claim 40, “the substrate includes a light for providing the visual signal” in claim 42, “the substrate includes one or more sensors including a pressure sensor, a flow rate sensor, a temperature sensor, an acoustic sensor, an infrared sensor, a camera, a force sensor, a capacitive sensor, a piezoresistive sensor, a moisture sensor, an oxygen sensor, or any combination thereof” in claim 43, and “the substrate is coupled to an external device including a mobile phone associated with the user, a smart speaker associated with the user, a desktop computer associated with the user, a laptop computer associated with the user, or any combination thereof” in claim 44. These limitations further define the mental process of determining a mask recommendation and do not “purport to improve the functioning of the computer itself" or "any other technology or technical field.” The claims merely include mere instructions to perform the method on a generic component or machinery. Even assuming if the claims provide an improvement (which the Office does not agree), the claims provide an improvement in the abstract idea itself, and thus is not an improvement in technology. See MPEP 2106.05(a)(II). Thus, it is determined that each one of the claims as a whole and the additional elements, individually or in ordered combination, fail to integrate the abstract ideas into a practical.
Regarding the consideration under MPEP 2106.05(b), the claims merely add generic computer components (i.e., the system, the substrate, the memory, the control system, the one or more processors, etc.) to perform conventional computer functions. It is important to note that a general purpose computer or generic computer components that apply a judicial exception, such as an abstract idea, by use of conventional computer functions do not qualify as a particular machine. See MPEP 2106.05(b)(1). Thus, each one of the claims as whole does not integrate the exception into a practical application.
Regarding the consideration under MPEP 2106.05(f), each one of the additional limitations in bold above is determined to be mere instructions to apply an abstract idea. These limitations are used to implement the abstract ideas recited at a high level of generality and are determined to be no more than mere instructions to implement the abstract ideas (i.e., the mental process of determining a mask recommendation) on generic computer components including the system, the substrate, the memory, the control system, and the one or more processors. Accordingly, for these additional reasons, each one of the claims as a whole and the additional limitations, individually or in ordered combination, do not integrate the abstract idea into a practical application.
Regarding the consideration under MPEP 2106.05(g), the additional limitation of “receiving data associated with the at least one in-and-out breath pair” in claim 18 is determined to not add more than insignificant extra-solution activity to the judicial exception. This limitation is a well-known pre-solution activity of necessary data gathering and is incidental to the primary process and thus merely a nominal or tangential addition to the claim. Accordingly, for these additional reasons, claim 18 as a whole does not integrate the abstract idea into a practical application.
Regarding the consideration under MPEP 2106.05(h), the additional limitations, individually or in combination, also amount to merely indicating a field of use or technological environment in which to apply the judicial exception. In the instant application, the additional limitations do no more than link the abstract idea (i.e., the mental process of determining a mask recommendation) to a particular technological environment, i.e., the field of respiratory therapy systems (as opposed to any other computer-aided diagnosis). Thus, the additional limitations fail to add an inventive concept to the claims.
Therefore, for at least these reasons, each one of claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 as a whole and the above-identified additional elements, individually or in combination, do not integrate the abstract ideas into a practical application under Step 2A, Prong Two.
Eligibility Step 2B:
Under Step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claims include an element or a combination of elements that are sufficient to amount to significantly more than the judicial exception (i.e., whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry). See MPEP 2106.05(II).
This evaluation is made with respect to the considerations that the Supreme Court has identified as relevant to the eligibility analysis, which are discussed in detail in MPEP 2106.05(a) through (h). See MPEP 2106.05(I)(A). Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. See MPEP 2106.05(II). Not all considerations will be relevant to every element, or every claim. Id. Although the conclusion of whether a claim is eligible at Step 2B requires that all relevant considerations be evaluated, most of these considerations were already evaluated in Step 2A Prong Two. Id. Thus, in Step 2B, examiners should:
Carry over their identification of the additional element(s) in the claim from Step 2A Prong Two;
Carry over their conclusions from Step 2A Prong Two on the considerations discussed in MPEP 2106.05(a) through (c), (e), (f) and (h);
Re-evaluate any additional element or combination of elements that was considered to be insignificant extra-solution activity per MPEP 2106.05(g), because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and
Evaluate whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d). Id.
Regarding independent claims 1 and 35, the Office carries over its identification of the additional elements from Step 2A, Prong Two so as to apply the same additional elements in Step 2B. See MPEP 2106.05(II). The Office further carries over conclusions from Step 2A, Prong Two on the considerations discussed in MPEP 2106.05(a) through (c), (e) through (h) so as to apply the same considerations in Step 2B.
Claims 1 and 35 recite limitations that are not enough to qualify as “significantly more” because those limitations simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry (i.e., the system, the substrate, the memory, the control system, the one or more processors, the motion sensor, the moisture sensor, the temperature sensor, the pressure sensor, the flow rate sensor, etc.). See MPEP 2106.05(d) and 2106.05(I)(A). Because the Office has determined that the additional elements, individually or in combination, are not unconventional under MPEP 2106.05(d), the Office cannot find that the additional elements are significantly more than the judicial exception. See MPEP 2106.05(g).
Regarding dependent claims 2 – 5, 9, 11 – 14, 16 – 18, 21, 37, and 39 – 44, the Office carries over its identification of the additional limitations in claims 18 and 36 – 44 from Step 2A, Prong Two so as to apply the same additional elements for the associated claims in Step 2B. See MPEP 2106.05(II). The Office further carries over conclusions from Step 2A, Prong Two on the considerations discussed in MPEP 2106.05(a) through (c) and (e) through (h) so as to apply the same considerations in Step 2B.
Therefore, claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 35, 37, and 39 – 44 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 1 – 3, 11 – 13, 35, and 37 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan (U.S. Pat. No. 5,245,995 A) in view of Sokol (U.S. Pub. No. 2020/0139165 A1) and Starr (U.S. Pat. No. 6,342,040 B1).
Regarding independent claims 1 and 35, Sullivan teaches the limitations of representative claim 35 identified in bold as:
A system for determining a breathing habit of a user, comprising: (Col.4, Lines 28 – 31 of Sullivan, The present inventors have recognized the detection of the noise of snoring or more particularly snoring patterns as a reliable parameter for detecting apneas as well as the imminent onset of apneic episodes..), comprising:
a substrate configured to be coupled to nostrils of the user, the substrate comprising:
a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate;
a memory storing machine-readable instructions (Col.14, Lines 20 – 32 of Sullivan. In the instant application, the broadest reasonable interpretation of “a memory storing machine-readable instructions” reads on the programmed microprocessor in Sullivan (Col.14, Lines 20 – 32) including recorded tables of indexes such as number of hypopneas and/or apneic episodes, their duration and time of occurrence.);
a control system integrated in the substrate, the control system including one or more processors configured to execute the machine-readable instructions to (Col.8, Line 61 to Col.9, Line 1 of Sullivan. In the instant application, the broadest reasonable interpretation of “a control system … including one or more processors configured to execute the machine-readable instructions” reads on the detection device 10 in Sullivan (Col.8, Line 61 to Col.9, Line 1) including an electronic processor/recorder which records signals from the microphone 11 either on a time basis or after preprogrammed processing so as to record for example tables of indexes such as the number of apneic episodes, their duration, etc.):
determine, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user;
responsive to the determination that the substrate is coupled to the nostrils of the user, turn on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor;
receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user;
analyze the received data to determine a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing (Col.5, Line 65 to Col.6, Line 7 of Sullivan. In the instant application, the broadest reasonable interpretation of “analyze the received data to determine, for a selected timeframe, whether the user is breathing through the nostrils of the user” reads on the activity in Sullivan (Col.3, Lines 50 – 52) of deriving the breathing rate or interruption of breathing.) through the nostrils of the user;
determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses; and
based at least in part on a result of the analysis, cause a mask recommendation to be communicated to the user (Col.17, Lines 31 – 43 of Sullivan, A convenient way to gauge whether a correct therapeutic or maximum, pressure has been selected is to use the diagnostic device shown in FIG. 7 of this invention while the patient is undergoing CPAP therapy. Should the recorded data show no signs of apneic periods then the setting may be assumed to be adequate at least for the patient when in a similar physical condition. Another long term benefit can be gained by recording the pressure level applied to the patient during sleep periods in which CPAP is applied using the feedback device of this invention. By making such recordings spaced over a period of time the skilled physician can diagnose any long term changes in the patient's condition. In the instant application, the broadest reasonable interpretation of “based at least in part on a result of the analysis, cause a mask recommendation to be communicated to the user” reads on the recordings in Sullivan (Col.17, Lines 31 – 43), during sleep periods spaced over a period of time.)
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “a substrate configured to be coupled to nostrils of the user, the substrate comprising:” (Paragraphs [0110], [0124], and [0160] of Sokol. In the instant application, the broadest reasonable interpretation of “a substrate configured to be coupled to nostrils of the user” reads on the sensing module in Sokol (Paragraphs [0110], [0124], and [0160]) including a sensing device (i.e., the substrate) worn inside a user’s nasal passage.).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate” (Paragraph [0171] of Sokol. In the instant application, the broadest reasonable interpretation of “a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate” reads on the sensor module (i.e., the substrate) in Sokol (Paragraph [0171]) including more than one sensor for sampling parameters of moving air (e.g. pressure, velocity, temperature, and humidity).).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “a control system integrated in the substrate, the control system including one or more processors configured to execute the machine-readable instructions to” (Paragraph [0160] of Sokol. In the instant application, the broadest reasonable interpretation of “a control system integrated in the substrate” reads on the sensing module in Sokol (Paragraph [0160]) including the sensor module including complementary sensors, including the microelectromechanical systems (MEMS) or nanoelectromechanical systems (NEMS) sensors. The Office has determined that it was well-known to a person of ordinary skill in the art at the time of filing that the microelectromechanical systems (MEMS) or nanoelectromechanical systems (NEMS) sensors each includes processors, with the sensor module including the microelectromechanical systems (MEMS) or nanoelectromechanical systems (NEMS) sensors having the processors.).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “determine, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user” (Paragraphs [0171] and [0214] of Sokol. In the instant application, the broadest reasonable interpretation of “determine, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user” reads on the activity in Sokol (Paragraphs [0171] and [0214]) of determining, using improper sensor readings by the more than one sensor for sampling parameters of moving air (e.g. pressure, velocity, temperature, and humidity), that the sensing system is improperly positioned within a user's nose.).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “responsive to the determination that the substrate is coupled to the nostrils of the user, turn on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor” (Paragraphs [0170] – [0178] and [0214] of Sokol. In the instant application, the broadest reasonable interpretation of “electronics provided on the substrate … the electronics including at least one of a pressure sensor and a flow rate sensor” reads on the sensing module in Sokol (Paragraph [0171]) containing more than one sensor, such that other parameters of the moving air (e.g. pressure, velocity, temperature, and humidity) are sampled. The broadest reasonable interpretation of “responsive to the determination that the substrate is coupled to the nostrils of the user” reads on the activity in Sokol (Paragraph [0214]) of determining, using improper sensor readings by the more than one sensor for sampling parameters of moving air (e.g. pressure, velocity, temperature, and humidity), that the sensing system is improperly positioned within a user's nose. The broadest reasonable interpretation of “turn on electronics … to a monitoring state to monitor data associated with the user” reads on the sensing module in Sokol (Paragraphs [0170] – [0178]) partially or entirely powered by a power generating module capable of converting mechanical energy from breathing into electrical energy.).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user” (Paragraphs [0110], [0124], [0160], and [0170] – [0178] of Sokol. In the instant application, the broadest reasonable interpretation of “the substrate” reads on the sensing module in Sokol (Paragraphs [0110], [0124], and [0160]) including a sensing device (i.e., the substrate) worn inside a user’s nasal passage. The broadest reasonable interpretation of “the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor” reads on the parameters in Sokol (Paragraph [0171]) of the moving air (e.g. pressure, velocity, temperature, and humidity).).
Sullivan does not appear to explicitly disclose, but Starr teaches the limitation identified in bold as “receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user” (Col.9: Lines 24 – 41 of Starr. In the instant application, the broadest reasonable interpretation of “the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user” reads on the pressure sensor in Starr (Col.9: Lines 24 – 41) including a diaphragm having one side communicating with the interior portion of the user interface (e.g., the mask covering at least one of the nostrils of the user) and another side communicating with ambient atmosphere. The Office has determined that it was well known to a person of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing that a diaphragm for a pressure sensor that deflects based on a pressure differential, e.g., between ambient pressure and the user’s exhaled breath or inhaled breath.).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “analyze the received data to determine a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing” (Col.1: Lines 43 – 48; Col.9: Lines 6 – 12 and 24 – 41; and Col.10, Lines 1 – 17 of Starr. In the instant application, the broadest reasonable interpretation of “analyze the received data to determine a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level” reads on the activity in Starr (Col.9: Lines 6 – 12 and 24 – 41; and Col.10, Lines 1 – 17) of analyzing the pressure differential between the interior portion of the user interface (i.e., around the nostrils within a mask) and the ambient atmospheric pressure outside the user interface to determine a signal representing the total gas volume exiting or entering the interior portion of the user interface. The broadest reasonable interpretation of “using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing” reads on the activity in Starr (Col.1: Lines 43 – 48) of distinguishing between inspiration and expiration based on a signal associated with a difference between the temperature of breath exhaled by the patient and the temperature of breath inhaled by the patient.).
Sullivan does not appear to explicitly disclose, but Sokol teaches the limitation identified in bold as “determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses” (Paragraphs [0009], [0115], [0176], and [0189] of Sokol. In the instant application, the broadest reasonable interpretation of “determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline” reads on the activities in Sokol (Paragraphs [0009], [0115], and [0189]) of performing a pair of measurements (i.e., one occurring during inhalation and the other occurring during exhalation), providing a baseline profile specifying a user health profile at an initial point in time, and comparing changes in the user’s health profile (e.g., the composition of air exhaled by the user) with the baseline. The broadest reasonable interpretation of “configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses” reads on the activities in Sokol (Paragraphs [0176] and [0189]) of using information from a pressure sensor to anticipate when the next exhalation cycle will be, using that prediction to perform a pair of measurements (i.e., one occurring during inhalation and the other occurring during exhalation), and calibrating a sensor against a baseline sensor or baseline reference and/or correcting for sensor bias.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan to: implement the substrate configured to be coupled to nostrils of the user, implement the motion sensor, the moisture sensor, and the temperature sensor disposed on the substrate, implement the control system integrated in the substrate, include the activity of determining, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user, include the activity, responsive to the determination that the substrate is coupled to the nostrils of the user, of turning on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor, implement from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, and include the activity of determining a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses, as taught by Sokol (Paragraphs [0110], [0115], [0124], [0160], [0170] – [0178], [0189], and [0214]) in order to provide air filtration/respiratory devices that are effective, comfortable, easy to use by people suffering from various impairments, compact, aesthetically pleasing, can notify users of air pollution hazards and/or recommend certain corrective actions to users to improve their health and/or well-being, and that do not hinder a user's ability to communicate with others (Paragraph [0004] of Sokol); and implement the at least one of a pressure sensor and the flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user, and include the activity of analyze the received data to determine a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing, as taught by Starr (Col.1: Lines 43 – 48; Col.9: Lines 6 – 12 and 24 – 41; and Col.10, Lines 1 – 17) in order to improve the comfort and effectiveness of providing ventilatory support to a patient through the upper airways to assist the patient breathing and/or maintain adequate oxygen levels in the body by doing some or all of the work of breathing (Paragraph [0006] of Starr).
Regarding claim 2, Sullivan as modified by Sokol and Starr and applied to claim 1 teaches the limitation identified in bold as “the selected timeframe is at least about 90 percent of the sleep session” (Col.16, Lines 60 – 63 of Sullivan. In the instant application, the broadest reasonable interpretation of “the selected timeframe is at least about 90 percent of the sleep session” reads on the timeframe in Sullivan (Col.16, Lines 60 – 63) being an entire sleep period.).
Regarding claim 3, Sullivan as modified by Sokol and Starr and applied to claim 1 teaches the limitation identified in bold as “the selected timeframe is a total period of time during the sleep session that the user is asleep” (Col.16, Lines 60 – 63 of Sullivan. In the instant application, the broadest reasonable interpretation of “the selected timeframe is a total period of time during the sleep session that the user is asleep” reads on the timeframe in Sullivan (Col.16, Lines 60 – 63) being an entire sleep period.).
Regarding claim 11, Sullivan as modified by Sokol and Starr and applied to claim 1 teaches the limitation identified in bold as:
determining, from the received data, a breathing pattern of the user, wherein the breathing pattern includes (a) inhaling through the nostrils, inhaling through a mouth of the user, or both, and (b) exhaling through the nostrils, exhaling through the mouth, or both (Col.6, Lines 41 – 45 of Sullivan. In the instant application, the broadest reasonable interpretation of “determining, from the received data, a breathing pattern of the user, wherein the breathing pattern includes (a) inhaling through the nostrils, inhaling through a mouth of the user, or both, and (b) exhaling through the nostrils, exhaling through the mouth, or both” reads on the activity in Sullivan (Col.6, Lines 41 – 45) and known to one of ordinary skill in the art, because it would be obvious to try in view of the finite number of identified, predictable solutions.); and
wherein the mask recommendation indicates the breathing pattern of the user (Col.6, Lines 21 – 36, and Col.17, Lines 31 – 43 of Sullivan. In the instant application, the broadest reasonable interpretation of “wherein the mask recommendation indicates the breathing pattern of the user” reads on the recordings in Sullivan (Col.17, Lines 31 – 43), during sleep periods spaced over a period of time, including patterns of respiratory patterns, as well as snoring patterns, being used by the skilled physician to diagnose long-term changes in the patient’s condition to select correct therapeutic or maximum, pressure.).
Regarding claim 12, Sullivan as modified by Sokol and Starr and applied to claim 11 teaches the limitation identified in bold as “the breathing pattern is determined to include inhaling through the nostrils followed by exhaling through the nostrils based at least in part on the received data indicating a change in airflow direction through the nostrils” (Col.5, Line 65 to Col.6, Line 7 of Sullivan. In the instant application, the broadest reasonable interpretation of “the breathing pattern is determined to include inhaling through the nostrils followed by exhaling through the nostrils based at least in part on the received data indicating a change in airflow direction through the nostrils” reads on the activity in Sullivan (Col.5, Line 65 to Col.6, Line 7) of inhalation/exhalation including the beginning/end points of the breathing cycle, with the beginning/end points being used for integration of the air flow for the duration of the inspiration and/or expiration phase.).
Regarding claim 13, Sullivan as modified by Sokol and Starr and applied to claim 11 teaches the limitation identified in bold as “the breathing pattern is determined to include (i) inhaling through the nostrils followed by exhaling through the mouth, (ii) exhaling through the nostrils followed by inhaling through the mouth, (iii) inhaling through the mouth followed by exhaling through the nostrils, or (iv) exhaling through the mouth followed by inhaling through the nostrils, based at least in part on determining consecutive inhalations without expirations or consecutive expirations without inhalations through the nostrils” (Col.5, Line 65 to Col.6, Line 7 of Sullivan. In the instant application, the broadest reasonable interpretation of “the breathing pattern is determined to include (i) inhaling through the nostrils followed by exhaling through the mouth, (ii) exhaling through the nostrils followed by inhaling through the mouth, (iii) inhaling through the mouth followed by exhaling through the nostrils, or (iv) exhaling through the mouth followed by inhaling through the nostrils, based at least in part on determining consecutive inhalations without expirations or consecutive expirations without inhalations through the nostrils” reads on the activity in Sullivan (Col.5, Line 65 to Col.6, Line 7) and known to one of ordinary skill in the art, because it would be obvious to try in view of the finite number of identified, predictable solutions with a reasonable expectation of success.).
Regarding claim 37, Sullivan as modified by Sokol and Starr and applied to claim 35 teaches the limitation identified in bold as “the membrane is configured to measure a pressure associated with the user breathing” (Col.9: Lines 24 – 41 of Starr. In the instant application, the broadest reasonable interpretation of “the membrane is configured to measure a pressure associated with the user breathing” reads on the pressure sensor in Starr (Col.9: Lines 24 – 41) including a diaphragm having one side communicating with the interior portion of the user interface (e.g., the mask covering at least one of the nostrils of the user) and another side communicating with ambient atmosphere. The Office has determined that it was well known to a person of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing that the diaphragm for the pressure sensor measures a pressure associated with the user breathing in response to the diaphragm deflecting based on a pressure differential, e.g., between ambient pressure and the user’s exhaled breath or inhaled breath.).
Claims 4 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 1, and further in view of Doemer (U.S. Pub. No. 2018/0177433 A1).
Regarding claim 4, Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Doemer teaches the limitation identified in bold as “a duration of the selected timeframe is adjusted based at least in part on an apnea hypopnea index (AHi) value for the user” (Paragraph [0141] of Doeme. In the instant application, the broadest reasonable interpretation of “a duration of the selected timeframe is adjusted based at least in part on an apnea hypopnea index (AHi) value for the user” reads on the indices in Doemer (Paragraph [0141]) calculated for every sufficiently long nighttime therapy, namely: AHI (=number of apneas+hypopneas per artifact-free therapy period).).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to implement a duration of the selected timeframe is adjusted based at least in part on an apnea hypopnea index (AHi) value for the user, as taught by Doemer (Paragraph [0141]) in order to individually adapt a form of respiration to the patient’s needs (Paragraphs [0004] and [0005] of Doemer).
Claims 5 and 44 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to an associated one of claims 1 and 35, and further in view of Shouldice (U.S. Pub. No. 2023/0107369 A1).
Regarding claim 5, Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Shouldice teaches the limitation identified in bold as “the mask recommendation indicates a breathing habit of the user, the breathing habit of the user being one of a mouth-breathing habit or a nose-breathing habit” (Paragraphs [0004], [0163], [0166], and [0169] of Shouldice. In the instant application, the broadest reasonable interpretation of “the mask recommendation indicates a breathing habit of the user, the breathing habit of the user being one of a mouth-breathing habit or a nose-breathing habit” reads on the message in Shouldice (Paragraphs [0163], [0166], and [0169]) including reminders to the user to close his/her jaw during the sleep session or switch to a full-face mask because she is mouth breathing.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to implement the mask recommendation indicates a breathing habit of the user, the breathing habit of the user being one of a mouth-breathing habit or a nose-breathing habit, as taught by Shouldice (Paragraphs [0166] and [0169]) in order to provide a system that can detect if a user is mouth breathing, adjust appropriate settings on associated devices, and/or provide notifications to the user (Paragraph [0058] of Shouldice).
Regarding claim 44, Sullivan as modified by Sokol and Starr and applied to claim 35 teaches the limitation identified in bold as “the substrate is coupled to an external device including a mobile phone associated with the user, a smart speaker associated with the user, a desktop computer associated with the user, a laptop computer associated with the user, or any combination thereof” (Paragraph [0106] of Shouldice. In the instant application, the broadest reasonable interpretation of “the substrate is coupled to an external device including a mobile phone associated with the user, a smart speaker associated with the user, a desktop computer associated with the user, a laptop computer associated with the user, or any combination thereof” reads on the user device 170 in Shouldice (Paragraph [0106]) being a mobile device such as a smart phone, a laptop, or the like).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr such that the substrate is coupled to an external device including a mobile phone associated with the user, a smart speaker associated with the user, a desktop computer associated with the user, a laptop computer associated with the user, or any combination thereof, as taught by Shouldice (Paragraphs [0131) in order to provide a system that can detect if a user is mouth breathing, adjust appropriate settings on associated devices, and/or provide notifications to the user (Paragraph [0058] of Shouldice).
Claims 9 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 1, and further in view of White (U.S. Pub. No. 2019/0261889 A1).
Regarding claim 9, Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but White teaches the limitation identified in bold as:
determining a nose-breathing percent for the selected timeframe indicating a percentage of the selected timeframe that the user breathed through the nostrils (Col.6, Lines 54 – 66 of Sullivan. In the instant application, the broadest reasonable interpretation of “determining a …breathing percent for the selected timeframe indicating a percentage of the selected timeframe that the user breathed” reads on the activity in Sullivan (Paragraph [0035]) of determining the air flow rate inhaled or exhaled by the patient compared to a base line level for that patient during the time interval.); [and]
determining that the user is a nose-breather based at least in part on the nose-breathing percent for the selected timeframe exceeding a threshold (Col.6, Lines 54 – 68 of Sullivan. In the instant application, the broadest reasonable interpretation of “breathing percent for the selected timeframe exceeding a threshold” reads on the time interval in White (Paragraph [0035]) between the onset of each inspiration or expiration being compared to the base line level for that patient and further being greater than the base line.); and
determining that the user is a mouth-breather based at least in part on the nose-breathing percent for the percent of time being below the threshold (Col.6, Lines 64 – 68 of Sullivan. In the instant application, the broadest reasonable interpretation of “breathing percent for the percent of time being below the threshold” reads on the activity in Sullivan (Col.6, Lines 64 – 68) of determining the integrated inhaled or exhaled volume of air over the short time interval is less than the volume over the relatively large number of breaths by a specified amount.).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but White teaches the limitation identified in bold as “determining a nose-breathing percent for the selected timeframe indicating a percentage of the selected timeframe that the user breathed through the nostrils” (Paragraph [0035] of White. In the instant application, the broadest reasonable interpretation of “determining a nose-breathing percent for the selected timeframe indicating a percentage of the selected timeframe that the user breathed through the nostrils” reads on the activity in White (Paragraph [0035]) of determining whether the change in air pressure indicates that the user is breathing through the user's nose over a predetermined period of time.).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but White teaches the limitation identified in bold as “determining that the user is a nose-breather based at least in part on the nose-breathing percent for the selected timeframe exceeding a threshold” (Paragraph [0035] of White. In the instant application, the broadest reasonable interpretation of “determining that the user is a nose-breather based at least in part on the nose-breathing percent for the selected timeframe exceeding a threshold” reads on the activity in White (Paragraph [0035]) of determining whether the change in air pressure indicates that the user is breathing through the user's nose.).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but White teaches the limitation identified in bold as “determining that the user is a mouth-breather based at least in part on the nose-breathing percent for the percent of time being below the threshold” (Paragraph [0035] of White. In the instant application, the broadest reasonable interpretation of “determining that the user is a mouth-breather based at least in part on the nose-breathing percent for the percent of time being below the threshold” reads on the activity in White (Paragraph [0035]) of determining that the change in temperature indicates that the user is breathing through the user's mouth.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to include the activity of determining a nose-breathing percent for the selected timeframe indicating a percentage of the selected timeframe that the user breathed through the nostrils, the activity of determining that the user is a nose-breather based at least in part on the nose-breathing percent for the selected timeframe exceeding a threshold, and the activity of determining that the user is a mouth-breather based at least in part on the nose-breathing percent for the percent of time being below the threshold, as taught by White (Paragraph [0035]) in order to measure breathing in a sensitive, fast, and accurate manner that can lead to more effective interventions and provide longer term health benefits (Paragraph [0006] of White).
Claims 14 and 41 – 42 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to an associated one of claims 1, 11, 35, and 41, and further in view of Shah (U.S. Pub. No. 2017/0312117 A1).
Regarding claim 14, Sullivan as modified by Sokol and Starr and applied to claim 11 does not appear to explicitly disclose, but Shah teaches the limitation identified in bold as “the breathing pattern is determined to include inhaling through both the nostrils and the mouth or exhaling through both the nostrils and the mouth based at least in part on a pressure level around the nostrils being below a threshold” (Paragraph [0036] of Shah. In the instant application, the broadest reasonable interpretation of “the breathing pattern is determined to include inhaling through both the nostrils and the mouth or exhaling through both the nostrils and the mouth based at least in part on a pressure level around the nostrils being below a threshold” reads on the device in Shah (Paragraph [0036]) allowing for simultaneous nose and mouth breathing.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr such that the breathing pattern is determined to include inhaling through both the nostrils and the mouth or exhaling through both the nostrils and the mouth based at least in part on a pressure level around the nostrils being below a threshold, as taught by Shah (Paragraph [0036]) in order to provide a simpler and cheaper way to diagnose for obstructive sleep apnea (OSA) and develop portable sleep monitors—Home Sleep Testing machine (HST) complying with the federal Center for Medicare and Medicaid Services CMS guidelines and offering results comparable to that of a sleep laboratory setting (Polysomnography or PSG) in a home setting (Paragraph [0010] of Shah).
Regarding claim 41, Sullivan as modified by Sokol and Starr and applied to claim 35 teaches the limitation identified in bold as “the mask recommendation includes a visual signal, an auditory signal, a tactile signal, or a combination thereof” (Paragraph [0176] of Shah. In the instant application, the broadest reasonable interpretation of “the mask recommendation includes a visual signal, an auditory signal, a tactile signal, or a combination thereof” reads on the indicator in Shah (Paragraph [0176]) that can be a color coded system (such as green/yellow/red) or light up different labelled lights to depict the 3 outcomes.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr such that the mask recommendation includes a visual signal, an auditory signal, a tactile signal, or a combination thereof, as taught by Shah (Paragraph [0176]) in order to provide a simpler and cheaper way to diagnose for obstructive sleep apnea (OSA) and develop portable sleep monitors—Home Sleep Testing machine (HST) complying with the federal Center for Medicare and Medicaid Services CMS guidelines and offering results comparable to that of a sleep laboratory setting (Polysomnography or PSG) in a home setting (Paragraph [0010] of Shah).
Regarding claim 42, Sullivan as modified by Sokol and Starr and applied to claim 41 teaches the limitation identified in bold as “the substrate includes a light for providing the visual signal” (Paragraph [0176] of Shah. In the instant application, the broadest reasonable interpretation of “the substrate includes a light for providing the visual signal” reads on the indicator in Shah (Paragraph [0176]) that can be a color coded system (such as green/yellow/red) or light up different labelled lights to depict the 3 outcomes.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr such that the substrate includes a light for providing the visual signal, as taught by Shah (Paragraph [0036]) in order to provide a simpler and cheaper way to diagnose for obstructive sleep apnea (OSA) and develop portable sleep monitors—Home Sleep Testing machine (HST) complying with the federal Center for Medicare and Medicaid Services CMS guidelines and offering results comparable to that of a sleep laboratory setting (Polysomnography or PSG) in a home setting (Paragraph [0010] of Shah).
Claims 16 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 1, and further in view of Verzal (U.S. Pub. No. 2019/0175026 A1).
Regarding claim 16, Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but McCool teaches the limitations identified in bold as:
determining, from the received data, one or more sleeping positions of the user during the sleep session, the sleeping position including a supine sleep position, prone sleep position, left side sleep position, right side sleep position, a sleep position where a head of the user is elevated, or any combination thereof (Paragraph [0188] of Verzal. In the instant application, the broadest reasonable interpretation of “determining, from the received data, one or more sleeping positions of the user during the sleep session, the sleeping position including a supine sleep position, prone sleep position, left side sleep position, right side sleep position, a sleep position where a head of the user is elevated, or any combination thereof” reads on the activity in Verzal (Paragraph [0188]) of determining, by the data received from accelerometer 406, the sleep position (e.g. left side, right side, supine, etc.).); and
determining, for each sleeping position, a corresponding breathing habit of the user (Paragraph [0188] of Verzal. In the instant application, the broadest reasonable interpretation of “determining, for each sleeping position, a corresponding breathing habit of the user” reads on the activity in Verzal (Paragraph [0188]) of determining, by the data received from accelerometer 406, the effectiveness of SDB therapy according to sleep position.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to include the activity of determining, from the received data, one or more sleeping positions of the user during the sleep session, the sleeping position including a supine sleep position, prone sleep position, left side sleep position, right side sleep position, a sleep position where a head of the user is elevated, or any combination thereof, and the activity of determining, for each sleeping position, a corresponding breathing habit of the user, as taught by Verzal (Paragraph [0188]) in order to improve sleep parameters with obstructive sleep apnea (OSA) treatment (Paragraph [0337] of Verzal).
Claims 17 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol, Starr, and Verzal and applied to claim 16, and further in view of Shouldice.
Regarding claim 17, Sullivan as modified by Sokol, Starr, and Verzal and applied to claim 16 teaches the limitation identified in bold as “the mask recommendation further indicates a recommended sleeping position of the user as any of the sleeping positions where the corresponding breathing habit of the user is a nose-breathing habit” (Paragraph [0188] of Verzal, In the instant application, the broadest reasonable interpretation of “the mask recommendation further indicates a recommended sleeping position of the user as any of the sleeping positions” reads on the information in Verzal (Paragraph [0188]) regarding sleep position being communicated to the patient during a sleep period.).
Sullivan as modified by Sokol, Starr, and Verzal and applied to claim 16 does not appear to explicitly disclose, but Shouldice teaches the limitation in bold identified as “the mask recommendation further indicates a recommended sleeping position of the user as any of the sleeping positions where the corresponding breathing habit of the user is a nose-breathing habit” (Paragraph [0004] of Shouldice. In the instant application, the broadest reasonable interpretation of “the corresponding breathing habit of the user is a nose-breathing habit” reads on the activity in Shouldice (Paragraphs [0163], [0166], and [0169]) of reminding the user to close his/her jaw during the sleep session (e.g., via a chin strap or similar means), use a different mask, or wake up.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol, Starr, and Verzal to implement the mask recommendation further indicating a recommended sleeping position of the user as any of the sleeping positions where the corresponding breathing habit of the user is a nose-breathing habit, as taught by Shouldice (Paragraphs [0163], [0166], and [0169]) in order to provide a system that can detect if a user is mouth breathing and provide notifications to the user (Paragraph [0058] of Shouldice).
Claims 18 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 1, and further in view of NPL Pouriayevali and Hess (U.S. Pub. No. 2019/0209044 A1).
Regarding claim 18, Sullivan as modified by Sokol and Starr and applied to claim 1 teaches the limitation identified in bold as:
causing an instruction to perform at least one in-and-out breath pair to be communicated to the user, wherein the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils;
receiving data associated with the at least one in-and-out breath pair (Col.12, Line 54 to Col.13, Line 4 of Sullivan. In the instant application, the broadest reasonable interpretation of “receiving data associated with the at least one in-and-out breath pair” reads on the activity in Sullivan (Col.12, Lines 54 – 66) of receiving, from the pressure sensor, signals based on pressure waves generated by the patient snoring or by variations in the respiration rate or pattern of the patient.); and
determining a nose-breathing baseline for the user based at least in part on the data associated with the at least one in-and-out breath pair;
wherein the mask recommendation is further based at least in part on the nose-breathing baseline for the user (Col.17, Lines 31 – 43 of Sullivan. In the instant application, the broadest reasonable interpretation of “the mask recommendation” reads on the recordings in Sullivan (Col.17, Lines 31 – 43), during sleep periods spaced over a period of time in which CPAP is applied using the feedback device.).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Hess teaches the limitation identified in bold as “causing an instruction to perform at least one in-and-out breath pair to be communicated to the user, wherein the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils” (Paragraph [0161] of Hess. In the instant application, the broadest reasonable interpretation of “causing an instruction to perform at least one in-and-out breath pair to be communicated to the user, wherein the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils” reads on the activity in Hess (Paragraph [0161]) of saying, via the message 522 in the screen, “Breath into the mask to help Tobi walk to the zoo.”).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Hess teaches the limitation identified in bold as “causing an instruction to perform at least one in-and-out breath pair to be communicated to the user, wherein the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils” (First Paragraph on Page 10 of NPL Pouriayevali. In the instant application, the broadest reasonable interpretation of “the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils” reads on the device in NPL Pouriayevali (First Paragraph and Figure 5 on Page 10) having short tubes that are placed at the nostrils along the airflow direction, to sense the stagnation pressure for respiration monitoring.).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Hess teaches the limitation identified in bold as “determining a nose-breathing baseline for the user based at least in part on the data associated with the at least one in-and-out breath pair” (Paragraph [0163] of Hess. In the instant application, the broadest reasonable interpretation of “determining a nose-breathing baseline for the user based at least in part on the data associated with the at least one in-and-out breath pair” reads on the activity in Hess (Paragraph [0163]) of determining a baseline level of breathing for that particular patient is, such that the system can then calibrate the game automatically to the patient's breathing pattern, perhaps in a calm environment, e.g., of video games.)
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Hess teaches the limitation identified in bold as “the mask recommendation is further based at least in part on the nose-breathing baseline for the user” (Paragraph [0163] of Hess. In the instant application, the broadest reasonable interpretation of “the nose-breathing baseline for the user” reads on the baseline level in Hess (Paragraph [0163]) of breathing for that particular patient.)
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to: include the activity of causing an instruction to perform at least one in-and-out breath pair to be communicated to the user, as taught by Hess (Paragraph [0161]) in order to provide active distraction, such as playing video games, and facilitate improved management of anxiety, discomfort, and pain in pediatric patients (Paragraph [0005] of Hess); implement the in-and-out breath pair includes the user breathing in through the nostrils and breathing out through the nostrils, as taught by NPL Pouriayevali (First Paragraph and Figure 5 on Page 10) in order to provide the most comfort for the patient and avoid blocking the nasal airflow so the patient will not feel an external object in front of the nostrils (First Paragraph on Page 10 of NPL Pouriayevali); include the activity of determining a nose-breathing baseline for the user based at least in part on the data associated with the at least one in-and-out breath pair, and implement the nose-breathing baseline for the user, as taught by Hess (Paragraph [0163]) in order to provide active distraction, such as playing video games, and facilitate improved management of anxiety, discomfort, and pain in pediatric patients (Paragraph [0005] of Hess).
Claims 21 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 1, and further in view of Farrugia (U.S. Pub. No. 2008/0053440 A1).
Regarding claim 21, Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Farrugia teaches the limitation identified in bold as “determining, from the received data, a congestion level of the user, wherein the mask recommendation further indicates that data from a subsequent sleep session is required based at least in part on the congestion level being above a congestion threshold” (Col.17, Lines 31 – 43 of Sullivan. In the instant application, the broadest reasonable interpretation of “the mask recommendation” reads on the recordings in Sullivan (Col.17, Lines 31 – 43), during sleep periods spaced over a period of time in which CPAP is applied using the feedback device.).
Sullivan as modified by Sokol and Starr and applied to claim 1 does not appear to explicitly disclose, but Farrugia teaches the limitation identified in bold as “determining, from the received data, a congestion level of the user, wherein the mask recommendation further indicates that data from a subsequent sleep session is required based at least in part on the congestion level being above a congestion threshold” (Paragraphs [0020] – [0021] of Farrugia. In the instant application, the broadest reasonable interpretation of “determining, from the received data, a congestion level of the user, … data from a subsequent sleep session is required based at least in part on the congestion level being above a congestion threshold” reads on the activity in Farrugia (Paragraphs [0020] and [0021]) of determining, from a flow signal which is preferably calculated from speed of the blower or current to the blower, the apnea/hypopnea index (AHI), and automatically increasing the pressure for use during a new session when the AHI is greater than a threshold, e.g., 8.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to include the activity of determining, from the received data, a congestion level of the user, wherein the mask recommendation further indicates that data from a subsequent sleep session is required based at least in part on the congestion level being above a congestion threshold, as taught by Farrugia (Paragraphs [0020] and [0021]) in order to provide a device that can detect sleep disordered breathing (SDB) events and automatically and effectively determine an appropriate pressure response (Paragraph [0017] of Farrugia).
Claims 39 is rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 35, and further in view of NPL Pouriayevali and Shouldice.
Regarding claim 39, Sullivan as modified by Sokol and Starr and applied to claim 35 does not appear to disclose, but Shouldice teaches the limitation identified in bold as “the membrane is configured to determine whether the user is breathing through both nostrils or through one” (Last Paragraph on Page 69 of NPL Pouriayevali. In the instant application, the broadest reasonable interpretation of “the membrane” reads on the membrane or thin diaphragm in NPL Pouriayevali (Last Paragraph on Page 69). The broadest reasonable interpretation of “configured to determine whether the user is breathing through both nostrils or through one” reads on the activity in Shouldice (Paragraph [0131]) of using reflections to define aspects of the user's respiratory system (including if one or both nostrils are being used).).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to include the membrane, as taught by NPL Pouriayevali (Last Paragraph on Page 69) in order to provide the most comfort for the patient and avoid blocking the nasal airflow so the patient will not feel an external object in front of the nostrils (First Paragraph on Page 10 of NPL Pouriayevali); and implement the membrane being configured to determine whether the user is breathing through both nostrils or through one, as taught by Shouldice (Paragraphs [0131) in order to provide a system that can detect if a user is mouth breathing, adjust appropriate settings on associated devices, and/or provide notifications to the user (Paragraph [0058] of Shouldice).
Claims 40 and 43 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sullivan as modified by Sokol and Starr and applied to claim 35, and further in view of Farrugia (U.S. Pub. No. 2008/0053440 A1).
Regarding claim 40, Sullivan as modified by Sokol and Starr and applied to claim 35 does not appear to disclose, but NPL Pouriayevali teaches the limitation identified in bold as “the membrane is configured to measure a flow rate of air through the nostrils of the user” (Last Paragraph on Page 69 of NPL Pouriayevali. In the instant application, the broadest reasonable interpretation of “the membrane” reads on the membrane or thin diaphragm in NPL Pouriayevali (Last Paragraph on Page 69). The broadest reasonable interpretation of “the membrane is configured to measure a flow rate of air through the nostrils of the user” reads on the activity in NPL Pouriayevali (Last Paragraph on Page 9 to First Paragraph on Page 10; Figure 5 on Page 10) of placing short tubes at the nostril along the airflow, to sense the stagnation pressure for respiration monitoring.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to implement the membrane configured to measure a flow rate of air through the nostrils of the user, as taught by NPL Pouriayevali (Last Paragraph on Page 9 to First Paragraph on Page 10; Figure 5 on Page 10) in order to provide the most comfort for the patient and avoid blocking the nasal airflow so the patient will not feel an external object in front of the nostrils (First Paragraph on Page 10 of NPL Pouriayevali).
Regarding claim 43, Sullivan as modified by Sokol and Starr and applied to claim 35 does not appear to explicitly disclose, but NPL Pouriayevali teaches the limitation identified in bold as “the substrate includes one or more sensors including a pressure sensor, a flow rate sensor, a temperature sensor, an acoustic sensor, an infrared sensor, a camera, a force sensor, a capacitive sensor, a piezoresistive sensor, a moisture sensor, an oxygen sensor, or any combination thereof” (Last Paragraph on Page 69 to First Paragraph on Page 70 of NPL Pouriayevali. In the instant application, the broadest reasonable interpretation of “the substrate includes one or more sensors including a pressure sensor, a flow rate sensor, a temperature sensor, an acoustic sensor, an infrared sensor, a camera, a force sensor, a capacitive sensor, a piezoresistive sensor, a moisture sensor, an oxygen sensor, or any combination thereof” reads on the single substrate in NPL Pouriayevali (Last Paragraph on Page 9 to First Paragraph on Page 10; Figure 5 on Page 10; and Last Paragraph on Page 69 to First Paragraph on Page 70) including a pressure sensor, a temperature sensor, and a humidity sensor.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and computer-aided diagnosis at the time of filing to modify the system and method of Sullivan as modified by Sokol and Starr to implement the substrate including one or more sensors including a pressure sensor, a flow rate sensor, a temperature sensor, an acoustic sensor, an infrared sensor, a camera, a force sensor, a capacitive sensor, a piezoresistive sensor, a moisture sensor, an oxygen sensor, or any combination thereof, as taught by NPL Pouriayevali (Last Paragraph on Page 9 to First Paragraph on Page 10; Figure 5 on Page 10; and Last Paragraph on Page 69 to First Paragraph on Page 70) in order to provide the most comfort for the patient and avoid blocking the nasal airflow so the patient will not feel an external object in front of the nostrils (First Paragraph on Page 10 of NPL Pouriayevali).
Response to Arguments
Applicant's arguments (Third Paragraph on Page 8 to First Paragraph on Page 9 of the Amendment filed January 15, 2026) regarding the rejection of claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 28, and 35 – 44 under 35 U.S.C. § 101 have been fully considered and are moot in view of the new grounds of rejection necessitated by the amendment.
In the Amendment (Third Paragraph on Page 8 to First Paragraph on Page 9), Applicant argued that the limitation of “determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses” provides “a concrete, device-implemented calibration for the user (the nose-breathing baseline).” Applicant argued that the baseline calibrates the thresholds, and those calibrated thresholds are applied in subsequent processing. Applicant further argued that this process provides an enduring reconfiguration of the system's operating parameters rather than mere reporting of results, which amounts to a practical, machine focused implementation that addresses any alleged judicial exception by integrating the analysis into the operation of the device. The Office respectfully disagrees. At best, the combination of limitations identified as “determining a breathing habit of a user,” “determine … that the substrate is coupled to the nostrils of the user,” and “analyze the received data to determine, … for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing through the nostrils of the user” do not purport to improve the functioning of the computer itself or any other technology or technical field. The claims merely include mere instructions to perform the method on a generic component or machinery. Even assuming if the claims provide an improvement (which the Office does not agree), the claims provide an improvement in only the abstract idea itself (i.e., determining a mask recommendation), and thus is not an improvement in technology. See MPEP 2106.05(a)(II).
Applicant's arguments (Third Paragraph on Page 9 to First Paragraph on Page 10 of the Amendment filed January 15, 2026) regarding the rejections of claims 1 – 5, 9, 11 – 14, 16 – 18, 21, 28, and 35 – 44 under 35 U.S.C. § 103 have been fully considered and are moot in view of the new grounds of rejection necessitated by the amendment.
In the Amendment (filed January 15, 2026), Applicant amended independent claims 1 and 35, with representative claim 35 amended to add the limitations identified in bold as “a motion sensor, a moisture sensor, and a temperature sensor disposed on the substrate,” “a control system integrated in the substrate, the control system including one or more processors configured to execute the machine-readable instructions to,” “determine, using at least one of the motion sensor, the moisture sensor, or the temperature sensor that the substrate is coupled to the nostrils of the user,” “responsive to the determination that the substrate is coupled to the nostrils of the user, turn on electronics provided on the substrate to a monitoring state to monitor data associated with the user, the electronics including at least one of a pressure sensor and a flow rate sensor,” “receive, from the substrate, the data associated with the user during a sleep session, the data including respiration data associated with the user and at least one of moisture data generated by the moisture sensor or temperature data generated by temperature sensor, the at least one of a pressure sensor and a flow rate sensor including a membrane that deflects based on the user breathing, the membrane covering at least one of the nostrils of the user,” “analyze the received data to determine a respiration signal associated with the user, for a selected timeframe, wherein the analyzing comprises using pressure levels around the nostrils relative to an ambient pressure level, and using changes in at least one of humidity or temperature associated with exhalation and inhalation to determine whether the user is breathing through the nostrils of the user,” and “determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses.” In the Amendment (Third Paragraph on Page 9 to First Paragraph on Page 10), Applicant argued that the added limitation of “determine a nose-breathing baseline for the user based at least in part on data associated with at least one in-and-out breath pair and compare respiration data to the nose-breathing baseline, and configure one or more analysis thresholds based on the nose-breathing baseline for subsequent analyses” is not taught by the art of record. Therefore, the Office has determined that the amendment necessitated the new grounds of rejection and Applicant’s arguments have been fully considered and are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/V.C.I./Examiner, Art Unit 3686
/DEVIN C HEIN/Examiner, Art Unit 3686
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