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 .
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: receiver circuit configured to receive information and breath analyzer circuit configured to analyze the received data in claim 1, the physiological event detector configured to detect events in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 sets forth a receiver circuit configured to receive respiration information of a patient. The specification sets forth in paragraphs [0057] and [0058] that the receiver circuit may receive physiologic information from a patient and may sense a signal from a patient “via” a sensor and the sensor may be incorporated into a IMD or WMD. The receiver circuit may also receive a signal from a storage device and the receiver circuit may include other circuits( respiration, physical activity, or posture). Furthermore in paragraph [0063] the data receiver circuit can communicate a separate device and in paragraph [0077] the input unit may receive user input for programming the data receiver circuit and the controller circuit. It is clear in paragraph [0065] that the controller circuit(220) can be implemented as a microprocessor or general purpose processor that receives and executes instructions. However, the data receive circuit (210) appears to be more than just a sensor receiving physiologic signals. There does not seem to be similar details regarding the data receiver circuit(210) and how it is structurally implemented and how it receives sensed signals from a sensor or stored physiologic signal data, communicates with other devices, or may be programmed. It is not clearly set forth whether the data receiver circuit(210) is also a microprocessor or general purpose computer similar to the controller circuit(220) or a physical sensor for detecting physiologic signals.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 , the claim sets forth a data receiver circuit configured to receive respiration information from a patient however it is not clear from the specification what structure realizes the function. Does the data receiver circuit include sensors or is it a processor or computer in combination with sensors. For the purposes of examination it will be interpreted as a microprocessor or general purpose computer similar to the controller circuit set forth in the specification.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to an abstract idea without significantly more.
With Respect to claims 1, and 14 the claims recite the following limitation(s):
Claim 1: a receiver circuit configured to receive respiration information of a patient; and
a breath analyzer circuit configured to:
determine, from the received respiration information, two or more spatial respiration components along respective anatomical axes of the patient, including a first respiration component along an anterior-posterior (AP) axis and one or more second respiration components along a superior-inferior (SI) axis or a left-right (LR) axis; and
classify a breathing pattern as one of either chest breathing or diaphragmatic breathing using the determined two or more spatial respiration components.
Claim 14: method of monitoring respiration using a medical-device system, the method comprising:
receiving respiration information sensed from a patient;
determining, from the received respiration information, two or more spatial respiration components along respective anatomical axes of the patient, including a first respiration component along an anterior-posterior (AP) axis and one or more second respiration components along a superior-inferior (SI) axis or a left-right (LR) axis; and
classifying a breathing pattern as one of either chest breathing or diaphragmatic breathing using the determined two or more spatial respiration components.
Step 1- Claims 1, and 14 as a whole fall within one or more statutory categories since they are directed to a system and a method for classifying a breathing pattern.
Step 2a Prong 1 – The claimed invention is directed to non-statutory subject matter. The above limitations, under their broadest reasonable interpretation, fall within the “Certain
Mathematical concepts and mental processes grouping of abstract ideas, enumerated in MPEP
2106.04(a)(2)(II), in that they recite a series of mathematical calculations and mental steps which
Classify a breathing pattern of a patient. When given their BRI, the limitations are considered an abstract idea of being certain mathematical concepts and mental processes.
With respect to claim 1, It appears the primary improvement the claim is directed to is a system for recognizing breathing patterns such as chest breathing or diaphragmatic breathing based on a spatial analysis of the movement or acceleration of the chest or abdomen. The analyzed breathing patterns may then be used to determine risk of other physiologic events such as worsening heart failure.
The receiver circuit appears to be a general purpose processor that receives physiologic signals either from a sensor or from stored data and is considered an additional element and will be discussed as part of Step 2a prong 2.
The breath analyzer circuit is a microprocessor or general purpose processor programmed to determine from the received information from the receiver circuit two or more spatial components along anatomical axes and from the spatial components classify the breathing pattern as chest breathing or abdominal( diaphragmatic) breathing. The breath analyzer circuit appears to be directed to mathematical determinations and mental steps of taking the received signals and determining spatial components and once the spatial components are determined deciding whether they are indicative of chest breathing or abdominal breathing. It also seems this could be done simply by mentally observing a patient and watching their breathing and deciding whether the chest is primarily moving during breathing or the abdomen is primarily moving and designating the breathing as either chest or abdominal.
With respect to claim 14, , It appears the primary improvement the claim is directed to is a method for recognizing breathing patterns such as chest breathing or diaphragmatic breathing based on a spatial analysis of the movement or acceleration of the chest or abdomen. The analyzed breathing patterns may then be used to determine risk of other physiologic events such as worsening heart failure.
Similar to claim 1, the steps of claim 14 are merely directed to receiving respiration information, determining from the received information two or more spatial components along anatomical axes and from the spatial components classifying the breathing pattern as either chest breathing or abdominal( diaphragmatic) breathing.
This appears to be directed to merely the mathematical determinations and mental steps of taking the received signals and determining spatial components and once the spatial components are determined deciding whether they are indicative of chest breathing or abdominal breathing. It also seems this could be done simply by mentally observing a patient and watching their breathing and deciding whether the chest is primarily moving during breathing or the abdomen is primarily moving and designating the breathing as either chest or abdominal.
Step 2a Prong 2 - The recitation of the additional elements of a receiver circuit merely invokes such additional element(s) as a tool to perform the abstract idea. MPEP 2106.05(f). Further, the recitation of these additional element(s) in the claim generally links the use of the abstract idea to a particular technological environment or field of use, i.e., a computerized environment. MPEP 2106.05(h).
As such, under Prong 2 of Step 2A, when considered both individually and as a whole, the limitations of claims 1 and 14 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d)
With respect to claim 1, the receiver circuit appears to be a general purpose processor that receives physiologic signals either from a sensor or from stored data and is considered mere data gathering and does not appear that the receiver circuit includes more to integrate the abstract idea into a practical application. Receiving respiration information merely allows for the mathematical determination or mental steps of calculating, determining or observing from the data, spatial components of respiration, and based on the observation, classifying or deciding whether the data or the observation of the data is indicative of chest or diaphragmatic breathing.
With respect to claim 14, the steps of claim 14 do not appear to include additional elements that would include more to integrate the abstract idea into a practical application. The steps are merely directed to receiving respiration information, determining from the received information two or more spatial components along anatomical axes and from the spatial components classifying the breathing pattern as either chest breathing or abdominal( diaphragmatic) breathing.
This appears to be directed to merely the mathematical determinations and mental steps of taking the received signals and determining spatial components and once the spatial components are determined deciding whether they are indicative of chest breathing or abdominal breathing. It also seems this could be done simply by mentally observing a patient and watching their breathing and deciding whether the chest is primarily moving during breathing or the abdomen is primarily moving and designating the breathing as either chest or abdominal. As such, these additional elements do not integrate the abstract idea into a practical application and therefore the claim is directed to the judicial exception.
Step 2B - The recitation of the additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. These additional elements do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Even when considered as an ordered combination, the additional elements of claims 1 and 14 do not add anything that is not already present when they are considered individually. Therefore, under Step 2B, there are no meaningful limitations in claims 1 and 14 that transform the judicial exception into a patent eligible application such that the claim amounts to significantly more than the judicial exception itself (Step 2B: NO). MPEP 2106.05.
Accordingly, under the Subject Matter Eligibility test, claims 1 and 14 are ineligible.
Regarding claims 2 and 15, the addition of an accelerometer as a type of sensor to gather physiologic data and provide the data to the breath analyzer circuit is considered mere data gathering and does not appear to include more to integrate the abstract idea into a practical application. The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claims 3 and 16, The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern including calculating a breathing pattern score and does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claims 4 and 5, the addition of a plurality of accelerometers or a mulit-axis accelerometer as a type of sensor to gather physiologic data and provide the data to the breath analyzer circuit is considered mere data gathering and does not appear to include more to integrate the abstract idea into a practical application.
Regarding claim 6 , The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern including filtering the data and does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claims 7 and 17, the addition of an ambulatory medical device to gather physiologic data and provide the data to the breath analyzer circuit is considered mere data gathering and does not appear to include more to integrate the abstract idea into a practical application. The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claims 8 and 18 , The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern including the specific signal parameters and specific amplitudes and power of the signal and does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claim 9 , The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern including the type of physiologic signals received and does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claim 10 , The claim merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern including calculating a trend of the data and does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Regarding claims 11 -13 and 19-20 , the claims merely recites further mathematical concepts and mental processes to analyze the signal and classify the breathing pattern including detecting physiologic events and calculate a risk of disorder from the data and does not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
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 and 14 -15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheu et al.( US 20200038708) hereinafter Cheu et al.
Cheu et al. teaches system to optimize diaphragmatic breathing is disclosed. The system has a first sensor to measure breathing movement of a user's abdomen and output a signal related to the movement of the user's abdomen, a second sensor to measure breathing movement of the user's chest and output a signal related to the movement of the user's chest; and a control device communicatively coupled with the first sensor and the second sensor. The control device has one or more processors, a memory comprising set of program modules executable by one or more processors. an assessment module for receiving the signal from the first sensor and second sensor and converting the signals to a data input, and for comparing the data input to a predetermined data range representative of proper diaphragmatic breathing for the user and a communication interface for providing feedback based on the assessment modules comparison of the data input and the predetermined range so as to optimize the user's diaphragmatic breathing.
PNG
media_image1.png
621
608
media_image1.png
Greyscale
PNG
media_image2.png
364
488
media_image2.png
Greyscale
Regarding claims 1 and 14, Cheu et al. teaches receiver circuit configured to receive respiration information of a patient; and a breath analyzer circuit configured to determine, from the received respiration information, two or more spatial respiration components along respective anatomical axes of the patient, including a first respiration component along an anterior-posterior (AP) axis and one or more second respiration components along a superior-inferior (SI) axis or a left-right (LR) axis; and
classify a breathing pattern as one of either chest breathing or diaphragmatic breathing using the determined two or more spatial respiration components. Note Fig. 1 and 3, [0057] Still referring to FIG. 1, the chest sensor 102 may also comprise a plurality of hardware components 104. The hardware components 104 may comprise a microcontroller 106, a vibrating motor 108, a power source 110, an accelerometer 112, a gyroscope 160, and a communication interface 114. Paragraph [0058], The accelerometer 112 is configured to sense movement along the X, Y, and Z axis which is interpreted to include the superior-inferior (SI) axis or a left-right (LR) axis. Note figs. 4a and 4b and Paragraph [0071] and [0077], teaches when a user performs proper diaphragmatic breathing as it relates to their use scenario and as instructed by the control device 130 on which the interactive game is played, the chest sensor 102 will have minimal movement while the abdomen sensor 116 should move as much as possible up and down with each breath. This is interpreted by the examiner as a classification of whether the user is primarily chest breathing or diaphragmatically breathing and is based on degree or amount of movement of the chest relative to the abdomen.
Regarding claims 2 and 15, Cheu et al. teaches at least one accelerometer sensor configured to sense multiple directional acceleration signals of chest wall or abdominal movement correlated to respiration, the multiple directional acceleration signals including an anterior-posterior acceleration (XL-AP) signal, a superior-inferior acceleration (XL-SI) signal, and a left-right acceleration (XL-LR) signal,wherein the breath analyzer circuit is configured to: determine the two or more spatial respiration components using respective signal metrics of the sensed multiple directional acceleration signals; and classify the breathing pattern as the diaphragmatic breathing if the signal metric of the XL-AP signal is greater than the signal metric of the XL-SI signal and the signal metric of the XL-LR signal, and to classify the breathing pattern as the chest breathing if the signal metric of the XL-AP signal is no greater than any of the signal metric of the XL-SI signal or the signal metric of the XL-LR signal. Note Fig. 1 and 3, [0057] , Note figs. 4a and 4b and Paragraph [0071] and [0077]. The accelerometer 112 is configured to sense movement along the X, Y, and Z axis and the chest sensor 102 will have minimal movement while the abdomen sensor 116 should move as much as possible up and down with each breath. This is interpreted as a classification of whether the user is primarily chest breathing or diaphragmatically breathing.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3-5, 8-13, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheu et al.( US 20200038708) hereinafter Cheu et al. in view of Kwok et al.( US 7766840) herein after Kwok et al.
Regarding claims 3, 9-13, and 16 and 19-20, Cheu et al. teaches system to optimize diaphragmatic breathing as set forth above including [0055] Referring now to FIG. 1, a diagram of an exemplary diaphragmatic breathing system in accordance with one embodiment is shown generally at reference numeral 100. The embodiment 100 shows a diaphragmatic system for use in a therapy environment in which a first sensor or a chest sensor 102 and a second sensor or an abdomen sensor 116 act together with the control device 130 to train a patient or user on the best technique for proper diaphragmatic breathing based upon a medical condition input by an operator (e.g., medical professional) and [0073] the abdomen sensor 116 and chest sensor 102 may also be used to detect certain health conditions such as paradoxical breathing, which occurs when the diaphragm collapses during inhalation and expands during exhalation (the reverse of occurs during a normal breath), (interpreted by the examiner as chest breathing as opposed to abdominal breathing). Paragraph [0077], teaches when a user performs proper diaphragmatic breathing as it relates to their use scenario and as instructed by the control device 130 on which the interactive game is played, the chest sensor 102 will have minimal movement while the abdomen sensor 116 should move as much as possible up and down with each breath. This is interpreted by the examiner as a classification of whether the user is primarily chest breathing or diaphragmatically breathing and is based on degree or amount of movement of the chest relative to the abdomen. Paragraph [0088] the respirations or breathings of the user is compared with the predetermined values (or a value range) ( interpreted as a threshold) based on the user or the user's condition or the user's goals. Therefore, in Cheu et al., chest versus abdominal breathing is determined and “classified” or distinguished and can be used as an indicator of a medical condition of the patient and is based on degree of movement of the chest relative to the abdomen which will be seen as a difference in signal between the chest accelerometer versus the diaphragm accelerometer and is compared to a range or predetermined value i.e. threshold.
Cheu et al. does not specifically teach calculate a breathing pattern score and classify the breathing pattern as the diaphragmatic breathing if the breathing pattern score exceeds a threshold, or as the chest breathing if the breathing pattern score is below the threshold.
Kwok et al. teaches in the same field of endeavor evaluation of heart failure status based on a disordered breathing index. Patient respiration is sensed and a respiration signal is generated. Disordered breathing episodes are detected based on the respiration signal. A disordered breathing index is determined based on the disordered breathing episodes. The disordered breathing index is trended and used to evaluate heart failure status. The disordered breathing index may be combined with additional information and/or may take into account patient activity, posture, sleep stage, or other patient information. Paragraph (6), Various types of disordered respiration are associated with Heart Failure(HF). For example, rapid shallow breathing is one of the cardinal signs of heart failure. The appearance of rapid, shallow breathing in a HF patient is often secondary to increased pulmonary edema, and can indicate a worsening of patient status. An abnormally high respiration rate thus can be an indicator of HF decompensation. Paragraph (7), Because of the complex interactions between the cardiovascular, pulmonary, and other physiological systems, as well as the need for early detection of various diseases and disorders, an effective approach to monitoring and early diagnosis is needed. Accurately characterizing patient respiration aids in monitoring and diagnosing respiration-related diseases or disorders. Evaluating patient respiration information may allow an early intervention, preventing serious decompensation and hospitalization. Note paragraph (40), The combined metric or index may be compared to a threshold used for triggering an alert if a rapid increase in the severity of symptoms related to HF is detected. Paragraph (20) In accordance with embodiments of the invention, an implantable CRM device may monitor a patient's respiration, e.g., using transthoracic impedance sensors and/or other respiration sensors, to detect DB episodes and acquire other information related to the DB episodes. The DB information may be used to develop a DB index that quantifies some aspect of the patient's DB. The DB index may be trended over a period of time. The patient's HF status may be evaluated based on the DB trend and the evaluation may be presented to the clinician, possibly along with other information related to patient health. Paragraph (54) According to another aspect, the trend information may be used by the diagnostics unit 350 to automatically make a diagnosis and/or to automatically develop a control signal that is coupled to therapy control circuitry 370. The control signal may and direct the therapy control circuitry 370 to initiate, terminate, or modify therapy, such as a cardiac electrostimulation therapy, a drug therapy, a respiration therapy, and/or other types of therapy.
(55) The diagnostics unit 350 may compare the trends developed as described in the various embodiments, to one or more thresholds. The diagnostics unit 350 may detect or diagnose the presence of HF, may determine the progression or regression of HF symptoms, and/or may determine if therapy should be modified based on the comparison. Note also paragrphs (34) and (35) teach where the index may be indicative of worsening heart failure and (40) a metric or index based on a combination of patient activity and DB characteristics may be developed that allows earlier identification of patients in danger of a sudden worsening of HF symptoms. The combined metric or index may be compared to a threshold used for triggering an alert if a rapid increase in the severity of symptoms related to HF is detected.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Cheu et al. determining a breathing pattern score and classify the breathing pattern as the diaphragmatic breathing if the breathing pattern score exceeds a threshold, or as the chest breathing if the breathing pattern score is below the threshold and include other physical activity or posture information of the user and provide trend data and worsening heart failure event and likelihood of worsening heart failure as is recognized and taught by Kwok et al. to better diagnose disordered breathing and enhance the diaphragmatic breathing training to improve overall health.
Regarding claims 4-5, Cheu et al teaches wherein the at least one accelerometer sensor includes a plurality of single-axis accelerometers configured to sense, respectively, the multiple directional acceleration signals of chest wall or abdominal movement and wherein the at least one accelerometer sensor includes a multi-axis accelerometer. Note Fig. 1 and 3, [0057] Still referring to FIG. 1, the chest sensor 102 may also comprise a plurality of hardware components 104. The hardware components 104 may comprise a microcontroller 106, a vibrating motor 108, a power source 110, an accelerometer 112, a gyroscope 160, and a communication interface 114. Paragraph [0058], The accelerometer 112 is configured to sense movement along the X, Y, and Z axis which is interpreted to include the superior-inferior (SI) axis or a left-right (LR) axis. Note figs. 4a and 4b and Paragraph [0071] and [0077].
Regarding claims 8 and 18, Cheu et al does teach in paragraph [0077] the chest sensor 102 will have minimal movement while the abdomen sensor 116 should move as much as possible up and down with each breath. This is interpreted as a relationship to the sensor/accelerometer output will have a corresponding change in output due to the relative chest or abdominal movement. However Cheu et al. does not specifically teach wherein the respective signal metrics of the sensed multiple directional acceleration signals include respective signal amplitudes or signal power within a respiration cycle.
Kwok et al. teaches the centroid of the respiration signal with respect to tidal volume during hyperventilation portions of obstructive DB is expected to have a smaller time coordinate and a larger amplitude coordinate when compared to the respiration signal of central DB.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in Cheu et al where the respective signal metrics of the sensed multiple directional acceleration signals include respective signal amplitudes or signal power within a respiration cycle as taught by Kwok et al. as a means to determine sensor output characteristics and differences between chest and abdominal breathing patterns.
Claim(s) 6, 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheu et al.( US 20200038708) hereinafter Cheu et al. in view of Kwok et al.( US 7766840) herein after Kwok et al. and further in view of Shute et al.( US 20210030295) hereinafter Shute et al.
Regarding claims 7 and 17, Cheu et al. as modified by Kwok et al. does not teach an ambulatory medical device (AMD) configured for abdomen or chest placement, the at least one accelerometer sensor is included in the AMD and configured to sense the multiple directional acceleration signals along respective directions with respect to an orientation of the AMD, wherein the breath analyzer circuit is configured to determine a spatial relationship between the orientation of the AMD and the anatomical axes of the
patient, and to calibrate the multiple directional acceleration signals using the determined spatial relationship.
Shute et al. teaches in the same field of endeavor one or more sensors may be incorporated into or otherwise associated with the AMD 110, attached to the housing of the AMD 110, or associated with the AMD 100 or the lead system 108. Examples of the physiologic signals may include one or more of electrocardiogram, intracardiac electrogram, arrhythmia, heart rate, heart rate variability, intrathoracic impedance, intracardiac impedance, arterial pressure, pulmonary artery pressure, left atrial pressure, right ventricular (RV) pressure, left ventricular (LV) coronary pressure, coronary blood temperature, blood oxygen saturation, one or more heart sounds, endocardial acceleration or vibration signals, physical activity or exertion level, physiologic response to activity, posture, respiratory rate, tidal volume, respiratory sounds, body weight, or body temperature. The AMD 110 may include circuitry configured to process the received physiological signal, and detect a cardiac status (e.g., cardiac arrhythmia or worsening heart failure) or generate diagnostics, using the processed physiological signal. [0052] The device orientation calibration circuit 160 can calibrate subsequent information from the AMD sensor using the determined spatial relationship to correct for the orientation of the AMD.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Cheu et al. as modified by Kwok et al. an AMD configured to sense the multiple directional acceleration signals along respective directions with respect to an orientation of the AMD, wherein the breath analyzer circuit is configured to determine a spatial relationship between the orientation of the AMD and the anatomical axes of the patient, and to calibrate the multiple directional acceleration signals using the determined spatial relationship as taught by Shute et al. to improve overall physiologic sensing and event detection.
Regarding claim 6, Cheu et al. as modified by Kwok et al. does not teach wherein the breath analyzer circuit is configured to filter the sensed multiple directional acceleration signals to a respiration frequency range, and to determine the two or more spatial respiration components using the filtered multiple directional acceleration signals.
Shute et al. teaches in the same field of endeavor one or more sensors may be incorporated into or otherwise associated with the AMD 110, attached to the housing of the AMD 110, or associated with the AMD 100 or the lead system 108. Examples of the physiologic signals may include one or more of electrocardiogram, intracardiac electrogram, arrhythmia, heart rate, heart rate variability, intrathoracic impedance, intracardiac impedance, arterial pressure, pulmonary artery pressure, left atrial pressure, right ventricular (RV) pressure, left ventricular (LV) coronary pressure, coronary blood temperature, blood oxygen saturation, one or more heart sounds, endocardial acceleration or vibration signals, physical activity or exertion level, physiologic response to activity, posture, respiratory rate, tidal volume, respiratory sounds, body weight, or body temperature. The AMD 110 may include circuitry configured to process the received physiological signal, and detect a cardiac status (e.g., cardiac arrhythmia or worsening heart failure) or generate diagnostics, using the processed physiological signal. [0052] The device orientation calibration circuit 160 can calibrate subsequent information from the AMD sensor using the determined spatial relationship to correct for the orientation of the AMD. [0043] However, the IMD orientation may not be fixed in practice, but change over time. For example, some IMDs may migrate away from its initial implant position, rotate, or flip even if the IMD is initially implanted at a body position with proper device orientation. Some IMDs, such as insertable cardiac monitors (ICMs), may be associated with a higher incidence of rotation, flip, or migration, which may be due to their geometries and smaller sizes. In accordance with the changes in MD orientation, one or more signal characteristics (e.g., magnitudes, polarities, timing, temporal pattern, or frequency of spectral content, among others) may also change. [0073] In some examples, the IMD orientation circuit 222 may preprocess the IMD XL data 212. In an example, the preprocessing may include filtering the IMD XL data 212 using filters with specific passing/stop band and gain/attenuation effect to extract certain acceleration components of interest, such as those corresponding to body motion/vibration, heart sounds, or lung sounds.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Cheu et al. as modified by Kwok et al. a filtering the sensed multiple directional acceleration signals to a respiration frequency range, and to determine the two or more spatial respiration components using the filtered multiple directional acceleration signals as taught by Shute et. Al. to better compensate for patient motion while respiration monitoring is taking place.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al.( CN 115317870) teaches a device that can guide heart failure patients to perform abdominal respiration training; the quality of the abdominal breathing action is evaluated by the displacement induction between the waistband movable part and the waistband fixing part; monitoring the heart rate variation and evaluating the abdominal respiration training effect through the matched heart rate collecting device. The field needs related device guidance and management promoting abdominal respiration training of heart failure patients and evaluating feedback to ensure the training is effective, finally reducing heart failure patient breathing difficulty onset frequency, improving exercise tolerance, improving quality of life.
Tupin et al.( US 20110060215) teaches Existing methods used for respiratory assessment include: (1) the displacement method, which consists of wearing a chest wrap with adhesive sensors attached to it, (2) the thermistor method, which requires a facial mask for measuring respiration heat, (3) the impedance pneumography test, which attaches electrodes on the surface of the skin and measures chest movement, (4) the CO.sub.2 method, which consists of a continuous measurement of expired air and the utilization of infrared rays, and, (5) a piezoelectric external mechanical movement detection and correlation method. It is important to note that all of the above approaches fail to obtain direct information concerning the both the mechanical aspects of the respiratory process and the physiological changes within the lungs themselves during the respiratory process. [0138] An apparatus 10 of the present invention provides an individual with a simple, noninvasive apparatus 10 and one or more sensors 20 to distinguish chest breathing from abdominal breathing for diagnostic, biofeedback, drug/alcohol monitoring and other purposes.
Lange et al.( US 7077810) teaches method is provided for predicting an onset of a clinical episode, the method including sensing breathing of a subject, determining at least one breathing pattern of the subject responsively to the sensed breathing, comparing the breathing pattern with a baseline breathing pattern, and predicting the onset of the episode at least in part responsively to the comparison. Other embodiments are also described.
Zhang et al.( US 20150038854) teaches Systems and methods for detecting a worsening of patient's heart failure condition based, at least in part, on an increasing trend in a representative rapid shallow breathing index (RSBI) value over multiple days. [0038] The pulse generator 105 may optionally incorporate a patient activity sensor 120 such as, for example, an accelerometer that may be used to sense patient activity, posture, respiration and/or cardiac related conditions.
KUENZLER et al.( WO 2009094335) teaches Changes in patient status are assessed based at least in part on respiration parameters. A user can make selections regarding alert criteria options to be used in assessing patient status. Respiration is implantably sensed and respiration data is stored by an implantable device. A respiration parameter, such as respiration rate, is measured from the respiration data. The change in patient status is assessed by comparing the respiration parameter to the configured alert criteria. If the comparison of the respiration parameter and the configured alert criteria indicates a significant change in patient status, an alert signal is generated.
Persidsky et al.( US 20150342518) teaches a system and method to monitor, guide, and evaluate breathing, with respect to user definable breathing patterns, sequences, and preexisting breathing exercises, utilizing posture and diaphragm sensor signals and a method to process thereof, composed of hardware and software components. The application describes a system which monitors the output signals of sensors as part of a breath training device worn by a user for measuring the state of a user's posture and diaphragm to derive a filtered breath signal. [0020] One of the main challenges of such devices which track abdominal wall movement or angle changes, stems from the fact that various body movements, such as rocking back and forth, can mimic the angle changes and motions seen during breathing. Various mathematical and statistical techniques, with limited success, can be used in an attempt to isolate and disambiguate breathing components in the sensor signal from body movement noise, such as Principle Component Analysis and Fourier transforms. The ultimate problem is that the frequency of breathing, roughly in the 0.1 Hz to 0.4 Hz range, can largely overlap with the frequency of body movement, such as that resulting from posture changes or other natural movements. From a sensor's perspective, the difference can be practically indistinguishable.
ALLEN et al.( WO 2015171548) teaches a system for monitoring a respiratory rate that includes an accelerometer, a processor, and a casing that encloses the accelerometer and the processor. Optionally, the accelerometer is configured to measure movement of a diaphragm or breath-induced movements, in real time, by detecting tilts of the accelerometer. The accelerometer may be configured to measure movement of a diaphragm or breath-induced movements, in real time, by detecting tilts of the accelerometer. The accelerometer may be a one-axis, a two-axis, or a three-axis accelerometer. The processor may be connected to the accelerometer to process and filter signals that are associated with measurements from the accelerometer. In addition, the processor may be configured to compute the respiratory rate based on the filtered signals and convert the computed respiratory rate to a digital readout to then output the digital readout on a display. The filtering process of the signals received from the accelerometer may include establishing a baseline for each axis component of the accelerometer once the device is powered on and attached to a patient. An average acceleration from each axis component may then be determined and the measurements received from the accelerometer may be interpreted as deviations from the established baseline. The average acceleration may output peaks for each movement of the diaphragm, that is, for each breath that causes the chest of a patient to rise.
Dalal et al.( US 20080262360) teaches systems and methods for diagnosing one or more respiration distress manifestations by implantably recognizing their occurrence and evaluating information about the same to provide an indication of present or impending worsening heart failure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN L CASLER/Primary Examiner, Art Unit 3791
Prosecution Insights