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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 05/30/2024 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
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 1-15 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to “a system,” (i.e. a machine) and claim 14 is directed to “a method,” (i.e. a process), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
However, the claims are drawn to an abstract idea of “determination of whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated,” in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion) which requires the following limitations:
“Receive a first signal responsive to the subject’s breathing during the sleep session;
receive a second signal responsive to baroreceptor-initiated changes in sympathetic activity of the subject;
process the first and second signals to detect a change in sympathetic activity;
in response to the detected change in sympathetic activity exceeding a predetermined activity threshold:
process the first and second signals to determine whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated; and
generate a control signal for controlling the SDB therapy device, based on the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated.”
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea. In other words, Step 2A, Prong 1 of the subject-matter eligibility analysis is “Yes.”
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “a SDB therapy device,” “one or more first sensors,” “one or more second sensors,” “output user interface” and “computer program product,” are merely claimed to generally link the use of a judicial exception (e.g., pre-solution activity of data gathering and post-solution activity of presenting data) to (1) a particular technological environment or (2) field of use, per MPEP §2106.05(h); and are applying the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, per MPEP §2106.05(f). In other words, the claimed “gathering data regarding sympathetic activity and determining as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated,” is not providing a practical application, thus Step 2A, Prong 2 of the subject-matter eligibility analysis is “No.”
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “a SDB therapy device,” “one or more first sensors,” “one or more second sensors,” “output user interface” and “computer program product,” are claimed, these are generic, well-known, and conventional elements. As evidence that these are generic, well-known, and a conventional elements (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known, the Applicant’s specification discloses these in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a). As such, this satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
Moreover, the element of “SDB therapy device” is described in page 7, as follows:
“…the SDB therapy device 110 is a positive airway pressure (PAP) device… however, any PAP device may be used (e.g. having a CPAP machine, BiPAP machine or APAP machine, having a mask that fits only over the nose or mouth, etc.).” The element is reasonably interpreted as a CPAP machine, BiPAP machine or APAP machine which provides no details of anything beyond ubiquitous standard equipment. Similarly, the elements of a “one or more first sensor” and “one or more second sensors” are described in page 5, as follows “The one or more first sensors may include an airflow sensor. The one or more second sensors may, for example, include a cardiac sensor, an electrodermal response sensor, a brain activity sensor, a muscle sensor, a pulse oximetry sensor, an exhaled breath sensor, a pressure sensor and/or an ultrasound sensor.” These elements are a generic plurality of sensors used to measure a parameter with no description beyond what is otherwise known to be in existence. The element of “output user interface” is described on page 17, as follows “In Fig. 2, the output user interface 170 is a computer monitor; however, the skilled person will readily appreciate that any output user interface capable of providing a suitable user-perceptible output may be
used (e.g. a mobile device or a speaker).” This element is reasonably interpreted as any known generic output user interface capable of providing a suitable user-perceptible output. The element of “computer program product” is described in page 19, as follows “A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.” This element is reasonably interpreted as a storage medium which provides no details of anything beyond ubiquitous standard equipment
As such, the elements of “a SDB therapy device,” “one or more first sensors,” “one or more second sensors,” “output user interface” and “computer program product,” are reasonably understood as ubiquitous standard equipment within modern mobiles/smartphones having generic, well-known, and conventional elements and the elements do not provide anything significantly more. Therefore, Step 2B, of the subject-matter eligibility analysis is “No.”
In addition, dependent claims 2-13 and 15 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 2-13 and 15 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to claim 1 or 14. Therefore, claims 1-15 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The term “computer program code means” of claim 15 invoke 112(f). The specification cites “As such, there is also proposed a concept of a computer program comprising code means for implementing any described method when said program is run on a processing system (see page 18, lines 19-21)” but provides no further details.
Claim limitation “computer program code means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not provide further detail on what the “computer program code means” as it is only mentioned once on page 5, lines 35-37 without providing anymore structure or material. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “A computer program product comprising computer program code means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method according to claim 14.” However, it is unclear what is meant by “computer program code means” as it is unclear whether the computer program code means is a computer medium or software. The specification recites “There is also provided a computer program product comprising computer program code means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method described above (see page 5, lines 35-37)” but provides no further clarification. Furthermore, the phrase of “computer program code means” invokes the means-plus function treatment due to the lack of structure. It should be noted the claim language should include non-transitory (e.g. non-transitory computer program product). For examination purposes, as best understood, the “computer program code means” is read as a computer medium.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 11 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kahlert (US 20220203063 A1).
Regarding claim 1, Kahlert teaches a processing system (controller 16, Fig. 2 and [098]) for controlling a sleep disordered breathing, SDB, therapy device (CPAP 20, see Fig. 2) providing therapy to a subject during a sleep session of the subject (Kahlert teaches a sleep therapy system for providing PAP therapy to a user for the treatment of sleep apnea using a controller as seen in Fig. 2 and [0036], [0079]-[0080] and [0121]), the processing system being configured to:
receive a first signal responsive to the subject’s breathing during the sleep session (Kahlert teaches having an airflow sensor 10e to monitor for Cheyne-Stokes Respiration and therefore is monitoring a subject’s breathing when the subject is asleep as seen in Fig. 2 and [0130] and [0054]. Kahlert further teaches a chest belt 10f to sense respiration drive as seen in Fig. 2 and [0026]);
receive a second signal responsive to baroreceptor-initiated changes in sympathetic activity of the subject (Kahlert teaches an ECG sensor 10d wherein the ECG sensor detects a change in heart rate variability as seen in Fig. 2 and [0134]);
process the first and second signals to detect a change in sympathetic activity;
in response to the detected change in sympathetic activity exceeding a predetermined activity threshold (Kahlert teaches the sympathetic response to cardiac volume can be derived from the sensed parameters due to the fluid change as seen in [0189]-[0191]. Kahlert teaches the air flow sensor to detect a CSR pattern and the ECG sensor to detect a change in heart rate variability wherein a processing unit will quantify the data as seen in [0134]. Kahlert further teaches the CSR flow pattern is specific for an atrial overloading as seen in [0130]. The quantified data is than compared to prerecorded data to see if the changes are above a predefined threshold as seen in [0134], wherein sympathetic activity is a response to the increase in heart rate variability as seen in [0133]):
process the first and second signals to determine whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated; and
generate a control signal for controlling the SDB therapy device, based on the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated (Kahlert teaches an air flow sensor and a ECG sensor and therefore, controller 16 is able to determine whether the detected change is chemoreceptor-initiated or baroreceptor-initiated base on which sensor measurement is above the predefined threshold. Kahlert further teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134], therefore controller 16 is sending a signal to control the CPAP).
Regarding claim 2, Kahlert teaches the system of claim 1, and further teaches wherein:
the SDB therapy device is a positive airway pressure, PAP, device (CPAP 20, see Fig. 2);
wherein the control signal comprises a first control signal (Kahlert teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134], therefore controller 16 is sending a first control signal to control the CPAP 20), and
wherein the processing system is configured to:
determine an adjusted pressure to be provided by the PAP device, based on the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor; and
generate the first control signal to control the PAP device to provide air to the subject at an adjusted pressure (Kahlert teaches an air flow sensor and a ECG sensor and therefore, controller 16 is able to determine whether the detected change is chemoreceptor-initiated or baroreceptor-initiated base on which sensor measurement is above the predefined threshold. Kahlert further teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134], therefore controller 16 is sending a first control signal to control the CPAP 20).
Regarding claim 11, Kahlert teaches the system of claim 2, but does not teach configured to determine whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated by:
processing the first and second signals to determine whether the detected change in sympathetic activity corresponds to a sleep disordered breathing event;
in response to a determination that the detected change in sympathetic activity does not correspond to a sleep disordered breathing event, determining that the detected change in sympathetic activity is baroreceptor-initiated;
in response to a determination that the detected change in sympathetic activity corresponds to a sleep disordered breathing event, determining that the detected change in sympathetic activity is chemoreceptor-initiated.
However, Kahlert further teaches detecting and reacting to airway tissue welling using an air flow sensor 10g and a chest belt 10h to sense respiration drive as seen in [0155]-[0156] and [0161]-[0162]. Kahlert teaches increased respiration drive is a surrogate for increased sympathetic activity as seen in [1062]. When the measured data is above a predefined threshold, positional therapy is triggered along with controlling a CPAP therapy as seen in [0164] and [0172]. The CPAP pressure will be increased during inspiration to treat an obstructive event as seen in [0172]. Kahlert further teaches the analysis of the flow sensor in the expiration cycle is specific for an increased flow resistance of the upper airway which can be due to a narrowing of the upper airway as seen in [0161] and [0168]). The flow processing unit can be used to analyze the flow patterns to distinguish between an airway narrowing by an OSA event and an airway narrowing by tissue swelling as seen in [0169].
Kahlert teaches various physiological conditions can be identified from combinations of these sensed parameters and for the system to preferably detect each of the three types of fluid shift as seen in [0189] and [0191]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to include the chest belt and controller as taught by Kahler to sense respiration drive and increase CPAP pressure during inspiration to treat an obstructive event (see [0162] and [0172]). Modified Kahlert teaches configured to determine whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated by:
processing the first and second signals to determine whether the detected change in sympathetic activity corresponds to a sleep disordered breathing event (Modified Kahlert teaches detecting and reacting to airway tissue welling using an air flow sensor and a chest belt to sense respiration drive (see in [0155]-[0156] and [0161]-[0162]). Kahlert further teaches the analysis of the flow sensor in the expiration cycle is specific for an increased flow resistance of the upper airway which can be due to a narrowing of the upper airway as seen in [0161] and [0168]). The flow processing unit can be used to analyze the flow patterns to distinguish between an airway narrowing by an OSA event and an airway narrowing by tissue swelling as seen in [0169]. Therefore, the airflow sensor and chest belt can detect respiratory changes in sympathetic activity corresponding to a sleep disordered breathing event while the cardiac changes detected by the air flow sensor and ECG sensor does not correspond to a sleep disordered breathing event);
in response to a determination that the detected change in sympathetic activity does not correspond to a sleep disordered breathing event, determining that the detected change in sympathetic activity is baroreceptor-initiated (Page 13, lines 15-21 of applicant’s specification discusses a baroreceptor-initiated change in sympathetic activity is a change in sympathetic activity as a result of intrathoracic pressure. The change in cardiac parameters include venous flow return, atrial filling and stroke volume. Page 8, lines 16-23 further discusses an ECG sensor to measure cardiac activity. Kahlert teaches air flow sensor 10e to detect a CSR pattern wherein the CSR pattern is specific for an atrial overloading (see [0130]) and the ECG sensor 10d to detect a change in heart rate variability as seen in [0134]. When the quantified data from the sensors is compared to prerecorded data to see if the changes are above a predefined threshold, and the changes are above the predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [1034]. Kahlert further teaches lowering the mean PAP pressure to improve venous return flow and pulmonary flow as seen in [0144]);
in response to a determination that the detected change in sympathetic activity corresponds to a sleep disordered breathing event, determining that the detected change in sympathetic activity is chemoreceptor-initiated (Kahlert teaches detecting and reacting to airway tissue welling using an air flow sensor and a chest belt to sense respiration drive as seen in [0155]-[0156] and [0161]-[0162]. Kahlert teaches increased respiration drive is a surrogate for increased sympathetic activity as seen in [1062]. When the measured data is above a predefined threshold, positional therapy is triggered along with controlling a CPAP therapy as seen in [0164] and [0172]. The CPAP pressure will be increased during inspiration to treat an obstructive event as seen in [0172]).
Regarding claim 13, Kahlert teaches a system (Fig. 2 and [0121]) for controlling a sleep disordered breathing, SDB, therapy device providing therapy to a subject during a sleep session of the subject (Kahlert teaches a sleep therapy system for providing PAP therapy to a user for the treatment of sleep apnea as seen in Fig. 2 and [0036] and [0079]-[0080]), the system comprising:
one or more first sensors (airflow sensor 10e, see Fig. 2) configured to generate the first signal responsive to the subject’s breathing during the sleep session (Kahlert teaches having an airflow sensor 10e to monitor for Cheyne-Stokes Respiration and therefore is monitoring a subject’s breathing when the subject is asleep as seen in Fig. 2 and [0130] and [0054]);
one or more second sensors (ECG sensor 10d, see Fig. 2) configured to generate the second signal responsive to baroreceptor-initiated changes in sympathetic activity of the subject (Kahlert teaches an ECG sensor 10d wherein the ECG sensor detects a change in heart rate variability as seen in Fig. 2 and [0134]); and the
processing system of claim 1 (see claim 1 above), configured to receive the first and second signals from the one or more first sensors and one or more second sensors respectively (Kahlert teaches controller 16/processing unit to receive the measurements from the air flow sensor and the ECG sensor as seen in [0134]).
Regarding claim 14, Kahlert teaches a computer-implemented method for controlling a sleep disordered breathing, SDB, therapy device (CPAP 20, see Fig. 2) providing therapy to a subject during a sleep session of the subject (Kahlert teaches a sleep therapy system for providing PAP therapy to a user for the treatment of sleep apnea using a computer program to implement the method seen in Fig. 2 and [0036], [0071] and [0079]-[0080]), the computer-implemented method comprising:
receiving a first signal responsive to the subject’s breathing during the sleep session (Kahlert teaches having an airflow sensor 10e to monitor for Cheyne-Stokes Respiration and therefore is monitoring a subject’s breathing when the subject is asleep as seen in Fig. 2 and [0130] and [0054]. Kahlert further teaches a chest belt 10f to sense respiration drive as seen in Fig. 2 and [0026]);
receiving a second signal responsive to baroreceptor-initiated changes in sympathetic activity of the subject (Kahlert teaches an ECG sensor 10d wherein the ECG sensor detects a change in heart rate variability as seen in Fig. 2 and [0134]);
processing the first and second signals to detect a change in sympathetic activity;
in response to the detected change in sympathetic activity exceeding a predetermined activity threshold (Kahlert teaches the sympathetic response to cardiac volume can be derived from the sensed parameters due to the fluid change as seen in [0189]-[0191]. Kahlert teaches the air flow sensor to detect a CSR pattern and the ECG sensor to detect a change in heart rate variability wherein a processing unit will quantify the data as seen in [0134]. Kahlert further teaches the CSR flow pattern is specific for an atrial overloading as seen in [0130]. The quantified data is than compared to prerecorded data to see if the changes are above a predefined threshold as seen in [0134], wherein sympathetic activity is a response to the increase in heart rate variability as seen in [0133]):
processing the first and second signals to determine whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated; and
generating a control signal for controlling the SDB therapy device, based on the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated (Kahlert teaches an air flow sensor and a ECG sensor and therefore, controller 16 is able to determine whether the detected change is chemoreceptor-initiated or baroreceptor-initiated base on which sensor measurement is above the predefined threshold. Kahlert further teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134], therefore controller 16 is sending a signal to control the CPAP).
Regarding claim 15, Kahlert teaches a computer program product comprising computer program code means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method according to claim 14 (Kahlert teaches a computer program comprising computer program code to implement the method (see [0071], wherein the program may be stored/distributed on a suitable medium as seen in [0203]. Therefore, the process/method will be executed on a computer device comprising controller 16).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1).
Regarding claim 3, Kahlert teaches the system of claim 2, and further teaches wherein:
in response to a determination that the detected change in sympathetic activity is baroreceptor-initiated, the adjusted pressure is a decreased pressure (Page 13, lines 15-21 of applicant’s specification discusses a baroreceptor-initiated change in sympathetic activity is a change in sympathetic activity as a result of intrathoracic pressure. The change in cardiac parameters includes venous flow return, atrial filling and stroke volume. Page 8, lines 16-23 further discusses an ECG sensor to measure cardiac activity. Kahlert teaches air flow sensor 10e to detect a CSR pattern wherein the CSR pattern is specific for an atrial overloading (see [0130]) and the ECG sensor 10d to detect a change in heart rate variability as seen in [0134]. When the quantified data from the sensors is compared to prerecorded data to see if the changes are above a predefined threshold, and the changes are above the predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [1034]. Kahlert further teaches lowering the mean PAP pressure to improve venous return flow and pulmonary flow as seen in [0144])
But does not teach in response to a determination that the detected change in sympathetic activity is chemoreceptor-initiated, the adjusted pressure is an increased pressure.
However, Kahlert further teaches detecting and reacting to airway tissue welling using an air flow sensor 10g and a chest belt 10h to sense respiration drive as seen in [0155]-[0156] and [0161]-[0162]. Kahlert teaches increased respiration drive is a surrogate for increased sympathetic activity as seen in [1062]. When the measured data is above a predefined threshold, positional therapy is triggered along with controlling a CPAP therapy as seen in [0164] and [0172]. The CPAP pressure will be increased during inspiration to treat an obstructive event as seen in [0172].
Kahlert teaches various physiological conditions can be identified from combinations of these sensed parameters and for the system to preferably detect each of the three types of fluid shift as seen in [0189] and [0191]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to include the controller as taught by Kahler to sense respiration drive and increase CPAP pressure during inspiration to treat an obstructive event (see [0162] and [0172]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Matthew (US 20030111079 A1).
Regarding claim 4, Kahlert teaches the system of claim 2, but does not teach wherein the processing system is configured to:
generate the first control signal configured to control the PAP device to provide air to the subject at the adjusted pressure for a predetermined time period;
in response to the predetermined time period elapsing, generate a second control signal configured to control the PAP device to provide air to the subject at a previous pressure.
However, Matthew teaches generate the first control signal configured to control the PAP device to provide air to the subject at the adjusted pressure for a predetermined time period (Matthew teaches the controller to monitor gas leakage from the patient circuit and reduces a pressure provided to the patient by the pressure generating system for a predetermined period of time due to a determination the rate of leakage of gas exceeds a predetermined threshold as seen in [0016]);
in response to the predetermined time period elapsing, generate a second control signal configured to control the PAP device to provide air to the subject at a previous pressure (Matthew teaches increasing the pressure back to a prior pressure level after the predetermined period of time has elapsed as seen in [0016], and therefore generating a second control signal for the increase).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to include the controller as taught by Matthew to aid in preventing arousals by the patient while keeping a baseline pressure for the patient for comfort (see [0003]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Shelly (US 20110297156 A1).
Regarding claim 5, Kahlert teaches the system of claim 2, and further teaches wherein the processing system is configured to:
continue to process the first and second signals to detect a change in sympathetic activity (Kahlert teaches the processing unit to quantify the data from the air flow sensor and ECG sensor as seen in [0134])
but does not teach in response to the change in sympathetic activity failing to exceed the predetermined activity threshold, generate the second control signal configured to control the PAP device to provide air to the subject at a previous pressure.
However, Shelly teaches a flow sensor 62, pressure sensor 68 and controller 64 as seen in Fig. 1 and [0039]-[0041]. Shelly further teaches a method where if no SDB event has been detected, the method will return to step 80 as seen in Fig. 2 and [0048], wherein the primary cause of the SDB event is the lack of a respiratory drive as seen in [0049].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to include the controller as taught by Matthew to continue detecting and processing without any changes to pressure. Therefore, if no event has been found, the controller will only react after the event/threshold has been found/reached. This will prevent any unnecessary pressure changes that may lead to discomfort in the patient.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Novotni (US 20160008561 A1).
Regarding claim 6, Kahlert teaches the system of claim 2, and further teaches wherein the processing system is configured:
process the first and second signals to detect a change in sympathetic activity;
in response to the detected change in sympathetic activity exceeding a predetermined activity threshold (Kahlert teaches the sympathetic response to cardiac volume can be derived from the sensed parameters due to the fluid change as seen in [0189]-[0191]. Kahlert teaches the air flow sensor to detect a CSR pattern and the ECG sensor to detect a change in heart rate variability wherein a processing unit will quantify the data as seen in [0134]. Kahlert further teaches the CSR flow pattern is specific for an atrial overloading as seen in [0130]. The quantified data is than compared to prerecorded data to see if the changes are above a predefined threshold as seen in [0134], wherein sympathetic activity is a response to the increase in heart rate variability as seen in [0133]):
process the first and second signals to determine whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated;
determine an adjusted pressure to be provided by the PAP device, based on the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated; and
generate a first control signal configured to control the PAP device to provide air to the subject at the adjusted pressure (Kahlert teaches an air flow sensor and a ECG sensor and therefore, controller 16 is able to determine whether the detected change is chemoreceptor-initiated or baroreceptor-initiated based on which sensor measurement is above the predefined threshold. Kahlert further teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134], therefore controller 16 is sending a first control signal to control the CPAP 20 for the adjusted pressure).
But does not teach the processing system is configured to repeatedly, at predetermined intervals.
However, Novotni teaches respirator 10 for generating breathing gas flows and controlling breathing and an EIT arrangement 20 as seen in Fig. 1 and [0057]. Novotni further teaches maximum airway pressure to be kept stable until the percentage of extended alveoli exceeds a second threshold value, wherein the comparison is repeated in predetermined intervals in time during respiration as seen in [0040], [0095] and [0099].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to have the processing system configured to repeat at predetermined intervals as taught by Novotni to repeatedly check if a measurement has met/exceeded a threshold (see [0040]). This allows the processing system to repeatedly check at a specific predictable time period and can be adjusted if needed.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Burton (US 20050217674 A1).
Regarding claim 7, Kahlert teaches the system of claim 2, and further teaches configured to:
determine an initial adjusted pressure value based on the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated (Kahlert teaches an air flow sensor and a ECG sensor and therefore, controller 16 is able to determine whether the detected change is chemoreceptor-initiated or baroreceptor-initiated base on which sensor measurement is above the predefined threshold. Kahlert further teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134]. Therefore, there is an initial adjusted pressure value);
but does not teach obtain a pressure threshold value;
compare the initial adjusted pressure value and the pressure threshold value;
in response to the initial adjusted pressure value exceeding the pressure threshold value, set the pressure threshold value as the adjusted pressure; and
in response to the initial adjusted pressure value failing to exceed the pressure threshold value, set the initial adjusted pressure value as the adjusted pressure.
However, Burton teaches using different treatments to determine patient-specific thresholds values for arousals and SBD, wherein the template or profile are determined from the appropriate treatment at particular stage in a subject’s sleep as seen in [0111]. Burton further teaches the threshold characteristics can vary parameters such as the maximum delivered pressure values as seen in [0152]. Not to mention, Burton teaches significantly reducing arousal by restricting the application of pressure treatment until a patient is in a sleep stage where this pressure is not experienced or causes no adverse patient discomfort as seen in [0139]. Therefore, Burton teaches having a maximum pressure value based on sleep stage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to have a maximum pressure value based on sleep stage as taught by Burton since restricting pressure treatment until the patient is in a sleep stage where the pressure is not experienced would aid in reducing arousal and increasing comfort (see [0139]). Kahlert in view of Burton teaches obtain a pressure threshold value (Burton teaches obtaining a maximum pressure depending on the sleep stage as seen in [0111] and [0152]);
compare the initial adjusted pressure value and the pressure threshold value;
in response to the initial adjusted pressure value exceeding the pressure threshold value, set the pressure threshold value as the adjusted pressure; and
in response to the initial adjusted pressure value failing to exceed the pressure threshold value, set the initial adjusted pressure value as the adjusted pressure (Kahlert teaches an initial adjusted pressure value when the sensor measurement changes are above a predefined threshold as seen in [0134]. Burton teaches a maximum pressure depending on the sleep stage. As such, Kahlert in view of Burton teaches adjusting the CPAP 20 of Kahlert when the sensor measurements changes are above a predefined threshold. Wherein the change in pressure cannot exceed the maximum pressure value depending on the sleep stage (as taught by Burton), and as such the adjusted value would become the maximum pressure value. Else, the initial adjusted pressure value would be the adjusted pressure).
Regarding claim 8, Kahlert in view of Burton teaches the system of claim 7, and Burton further teaches configured to obtain the pressure threshold value by:
estimating a current sleep stage of the subject; and
selecting the pressure threshold value, from a set of pressure threshold values, according to the estimated current sleep stage (Burton teaches using different treatments to determine patient-specific thresholds values for arousals and SBD, wherein the template or profile are determined from the appropriate treatment at a particular stage in a subject’s sleep as seen in [0111]. Burton further teaches the threshold characteristics can vary parameters such as the maximum delivered pressure values as seen in [0152]. Therefore, Burton teaches selecting a maximum pressure value based on sleep stage).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Burton (US 20050217674 A1), as applied to claim 7 above, and further in view of Hete (US 20070044799 A1) as evidenced by Lotz (US 20140076317 A1).
Regarding claim 9, Kahlert in view of Burton teaches the system of claim 7, but does not teach wherein, in response to the initial adjusted pressure value exceeding the pressure threshold value, the processing system is further configured to generate a third control signal configured to control the PAP device to provide supplementary oxygen to the subject.
However, Hete teaches a patient treatment system 10 including a gas delivery system 16 and oxygen source 24 as the supplemental oxygen as seen in Fig. 1 and [0018].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert in view of Burton to include the supplemental oxygen as taught by Hete as it is known within the field of art to use supplemental oxygen with a gas delivery source (see [0005] and [0053]).
Furthermore, as evidenced by Lotz, supplemental oxygen can be used to support the patient if a patient’s SpO2 levels were to drop below a certain threshold despite receiving adequate therapy to treat a disorder (e.g. pressure for sleep disorder).
Modified Kahlert in view of Hete and evidenced by Lotz teaches wherein, in response to the initial adjusted pressure value exceeding the pressure threshold value, the processing system is further configured to generate a third control signal configured to control the PAP device to provide supplementary oxygen to the subject (Hete teaches having supplemental oxygen, wherein the supplemental oxygen would be used to support the patient alongside a gas delivery system to treat a sleep disorder (as evidenced by Lotz). Therefore, modified Kahlert in view of Hete and evidenced by Lotz teaches when the initial adjusted pressure value (taught by Kahlert) exceeds the maximum pressure value (taught by Burton), the controller would have CPAP 20 provide supplemental oxygen (taught by Hete as evidenced by Lotz) to the patient).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Eckert (US 20220218274 A1).
Regarding claim 10, Kahlert teaches the system of claim 1, but does not teach wherein the predetermined activity threshold is determined by:
using a machine-learning algorithm trained to predict a likelihood of arousal for the subject based on changes in sympathetic activity; and
wherein the predetermined activity threshold is set as a value of a change in sympathetic activity for which a likelihood of arousal predicted by the machine-learning algorithm exceeds a predetermined likelihood of arousal.
However, Eckert teaches taking data from measurements of patients with OSA to predict their key causes of OSA so that targeted treatments for optimal patient outcomes can be recommended as seen in [0034]. Eckert further teaches a method of determining a likely indicator for obstructive sleep apnea by including a step of measuring a subject’s parameters and utilizing the machine learning structure to determine arousal threshold as seen in [0040].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to use the machine learning algorithm as taught by Eckert for the arousal thresholds to constantly update based on subject’s parameters for a targeted treatment for optimal patient outcomes (see [0034] and [0040]). Kahlert in view of Eckert teaches wherein the predetermined activity threshold is determined by:
using a machine-learning algorithm trained to predict a likelihood of arousal for the subject based on changes in sympathetic activity; and
wherein the predetermined activity threshold is set as a value of a change in sympathetic activity for which a likelihood of arousal predicted by the machine-learning algorithm exceeds a predetermined likelihood of arousal (Eckert teaches using machine learning to determine arousal threshold based on the measurements of a subject’s parameter. As such, Kahlert in view of Eckert teaches the predetermined activity threshold is set based on the air flow sensor 10e measurements, ECG sensor 10d measurements and sympathetic activity in response to the measurements as seen in [0134] of Kahlert due to the machine learning as taught by Eckert).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahlert (US 20220203063 A1) in view of Shouldice (US 20200297955 A1).
Regarding claim 12, Kahlert teaches the system of claim 1, and further teaches configured to generate the control signal by:
processing the determination as to whether the detected change in sympathetic activity is chemoreceptor-initiated or baroreceptor-initiated to determine a control instruction for controlling the SDB therapy device (Kahlert teaches an air flow sensor and a ECG sensor and therefore, controller 16 is able to determine whether the detected change is chemoreceptor-initiated or baroreceptor-initiated base on which sensor measurement is above the predefined threshold. Kahlert further teaches when the changes are above a predefined threshold, the CPAP pressure settings are adapted accordingly as seen in [0134], therefore controller 16 is sending a signal to control the CPAP)
but does not teach generating a fourth control signal configured to control an output user interface to provide a user-perceptible output of the control instruction.
However, Shouldice teaches an output interface such as a display that can provide information and instructions to the user and an input interface to receive data and commands from the user as seen in [0109].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Kahlert to include the output interface and input interface as taught by Shouldice to provide information and/or instructions to the user and allow the user to input commands to make changes to the system (see [0109]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mulcahy (US 20090038616 A1) teaches acclimatizing a patient to pressure, wherein the pressure is adjusted for sleep stage.
Sorresso (US 20160067081 A1) teaches using positive pressure with supplemental oxygen to treat sleep disorders.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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