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 .
Claims Pending
Claims 1-20 are currently under examination.
Claim Objections
Claim 20 objected to because of the following informalities:
In claim 20, “and posture” (line 2) should read -posture-
Appropriate correction is required.
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:
Claim 1 and 16: The claim limitation “sensing circuitry configured to sense cardiac activity of a patient” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to sense cardiac activity of a patient” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
Claim 1 and 16: The claim limitation “processing circuitry configured to…” “…determine a heart failure risk based on the first posture state and the second posture state” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to…” “…determine a heart failure risk based on the first posture state and the second posture state” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
Claim 1 and 16: The claim limitation “processing circuitry configured to…” “…generate output based at least in part on the heart failure risk” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to…” “…generate output based at least in part on the heart failure risk” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
Claim 9: The claim limitation “processing circuitry configured to configured to determine the heart failure risk further based on the parameter indicative of heart failure” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to determine the heart failure risk further based on the parameter indicative of heart failure” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
Claim 12: The claim limitation “processing circuitry is further configured to automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
Claim 12: The claim limitation “adjustable bed is configured to elevate an upper body of the patient relative to a lower body of the patient” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “adjustable bed” coupled with functional language “configured to elevate an upper body of the patient relative to a lower body of the patient” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “adjustable bed”.
Claim 13: The claim limitation “processing circuitry is configured to determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
Claim 14: The claim limitation “processing circuitry is configured to determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “circuitry” coupled with functional language “configured to determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “circuitry”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Circuitry with electrodes, accelerometers, pressure sensors, optical sensors, or equivalents thereof, as described on Par. 61-62 of the disclosure filed on 07/25/2024.
A computational structure with an algorithm that outputs a metric based on posture changes, or equivalents thereof, as described on Par. 61, 62, and 70 and of the disclosure filed on 07/25/2024.
Communication circuitry, or equivalents thereof, as described on Par. 64 of the disclosure filed on 07/25/2024.
A computational structure with an algorithm that outputs a metric based on changes in a measured parameter, or equivalents thereof, as described on Par. 61, 62, and 88 of the disclosure filed on 07/25/2024.
A computational structure connected to a bed, or equivalents thereof, as described on Par. 61, 62, and 96 of the disclosure filed on 07/25/2024, which lacks sufficient detail within the applicant’s specification regarding the structure that achieves the indicated function, and will be interpreted as any generic computational structure connected to a bed.
A bed, or equivalents thereof, as described on Par. 96 of the disclosure filed on 07/25/2024, which lacks sufficient detail within the applicant’s specification regarding the structure of the bed that achieves the indicated function, and as such will be interpreted as the presence of any bed structure.
A computational structure with an algorithm, or equivalents thereof, as described on Par. 61, 62, and 40 of the disclosure filed on 07/25/2024, which lacks sufficient detail within the applicant’s specification, and will be interpreted as a generic computational structure with a generic algorithm capable of the indicated function.
A computational structure with an algorithm, or equivalents thereof, as described on Par. 61, 62, and 40 of the disclosure filed on 07/25/2024, which lacks sufficient detail within the applicant’s specification, and will be interpreted as a generic computational structure with a generic algorithm capable of the indicated function.
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 12-14 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 12 recites “wherein the processing circuitry is further configured to automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state”, where the applicant’s specification lacks sufficient detail in regards to the structure of the processing circuitry that achieves the function of “automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state”. The applicant’s specification does state “processing circuitry of system 2 may automatically regulate an angle of an adjustable bed on which patient 4 is sleeping based on the second posture state, where the adjustable bed is configured to elevate an upper body of patient 4 relative to a lower body of patient 4. For example, if at a first sleep angle patient 4 is changing sleep positions very frequently (which may indicate that patient 4 has difficulty breathing), processing circuitry of system 2 may automatically increase an angle of the adjustable bed to increase the sleep angle of patient 4.” (Par. 96 of applicant’s spec.). However, this merely further recites the function, without providing additional detail in regards to the structures that are involved with the indicated function. Is the bed electronic? How does the bed move? How does the angle increase? Does the bed have a processor? As such, the claim is rejected.
Claim 12 recites “adjustable bed is configured to elevate an upper body of the patient relative to a lower body of the patient”, where the applicant’s specification lacks sufficient detail in regards to the structure of the bed that achieves the function “elevate an upper body of the patient relative to a lower body of the patient”. The applicant’s specification does state “processing circuitry of system 2 may automatically regulate an angle of an adjustable bed on which patient 4 is sleeping based on the second posture state, where the adjustable bed is configured to elevate an upper body of patient 4 relative to a lower body of patient 4. For example, if at a first sleep angle patient 4 is changing sleep positions very frequently (which may indicate that patient 4 has difficulty breathing), processing circuitry of system 2 may automatically increase an angle of the adjustable bed to increase the sleep angle of patient 4.” (Par. 96 of applicant’s spec.). However, this merely further recites the function, without providing additional detail in regards to the structures that are involved with the indicated function. Is the bed electronic? How does the bed move? How does the angle increase? Does the bed have a processor? Is the bed a single unitary structure that bends? As such, the claim is rejected.
Claim 13 recites “processing circuitry is configured to determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model”, where the applicant’s specification lacks sufficient detail in regards to the structure of the processing circuitry that achieves the function of “determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model”. The applicant’s specification does state “may be inputs to a machine learning model and/or probability model configured to determine a heart failure risk (or other health condition) of patient 4. For example, techniques for applying physiological parameters to a Bayesian Belief Network or other probability model, such as deep learning convolution or long short term neural networks” (Par. 40 of applicant’s spec.). However, this merely further recites the existence of differing machine learning techniques without identifying the manner in which the techniques are used by the applicant. For example, the applicant’s specification lacks sufficient detail in regards to the specific weights, biases, or layers in the model itself or the manner in which the model is trained. As such, the claim is rejected.
Claim 14 recites “processing circuitry is configured to determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model”, where the applicant’s specification lacks sufficient detail in regards to the structure of the processing circuitry that achieves the function of “determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model”. The applicant’s specification does state “may be inputs to a machine learning model and/or probability model configured to determine a heart failure risk (or other health condition) of patient 4. For example, techniques for applying physiological parameters to a Bayesian Belief Network or other probability model, such as deep learning convolution or long short term neural networks” (Par. 40 of applicant’s spec.). However, this merely further recites the existence of differing machine learning techniques without identifying the manner in which the techniques are used by the applicant. For example, the applicant’s specification lacks sufficient detail in regards to the specific weights, biases, or layers in the model itself or the manner in which the model is trained. As such, the claim is rejected.
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “A system comprising:
an implantable medical device comprising:
an accelerometer configured to sense activity and posture of a patient; and
sensing circuitry configured to sense cardiac activity of a patient; and
processing circuitry configured to:”, which fails to effectively define the metes and bounds of the claim as it is unclear whether the “processing circuitry” is meant to be included as part of the “implantable medical device”. The paragraph spacing present within the filed appears to indicate that the processing circuitry is not included within the implantable device due to the lack of an indentation. However, at the same time, the claim also states “sensing circuitry configured to sense cardiac activity of a patient; and processing circuitry configured to:”, which appears to potentially indicate that the processing circuitry was intended to be part of the implantable medical device. Is the processing circuitry part of the implantable medical device or separate? As the claims are viewed in light of the applicant’s specification, Figure 3 of the applicant’s drawings further indicate the processing circuitry as being part of the implantable medical device. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the processing circuitry being part of the implantable medical device (Fig. 3 of applicant’s drawings).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 16, and 20 recite the broad recitation “responsive to one or more of a first signal from the accelerometer satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold”, and the claim also recites “wherein the accelerometer outputs the first signal at a first time, and wherein the sensing circuitry senses the first set of cardiac activity data at the first time” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, this will be interpreted as only a single of the limitations of “wherein the accelerometer outputs the first signal at a first time,” or “wherein the sensing circuitry senses the first set of cardiac activity data at the first time” as being required for the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 16, and 20 recites the broad recitation “responsive to one or more of a second signal satisfying a second threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold”, and the claim also recites “wherein the accelerometer outputs the second signal at a second time, and wherein the sensing circuitry senses the second set of cardiac activity data at the second time” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, this will be interpreted as only a single of the limitations of “wherein the accelerometer outputs the second signal at a second time” or “wherein the sensing circuitry senses the second set of cardiac activity data at the second time” as being required for the claim.
Claim 8 recites the limitation “wherein the first threshold is greater than the second threshold, wherein the first heart rate threshold is greater than the second heart rate threshold”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the manner in which the claim is intended to be interpreted. As indicated above, the limitations of claim 1 were interpreted as only a single of the limitations of “wherein the accelerometer outputs the second signal at a second time” or “wherein the sensing circuitry senses the second set of cardiac activity data at the second time” as being required for the claim. Additionally, as indicated above, the limitations of claim 1 were interpreted as only a single of “wherein the accelerometer outputs the first signal at a first time,” or “wherein the sensing circuitry senses the first set of cardiac activity data at the first time” as being required for the claim. As such, the applicant has failed to effectively define the metes and bounds of the claim as it is unclear as to whether both limitations of claim 8 are required or only a single limitation. For examination purposes, this will be interpreted as only a single limitation of “wherein the first threshold is greater than the second threshold” and “wherein the first heart rate threshold is greater than the second heart rate threshold” as being required for the claim (Examiner's Note: This interpretation aligns with the interpretation of independent claim 1).
Claim 12 limitation “wherein the processing circuitry is further configured to automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state” 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. It is unclear as to the manner in which the processing circuitry regulates the angle of the bed. The applicant’s specification does state “processing circuitry of system 2 may automatically regulate an angle of an adjustable bed on which patient 4 is sleeping based on the second posture state, where the adjustable bed is configured to elevate an upper body of patient 4 relative to a lower body of patient 4. For example, if at a first sleep angle patient 4 is changing sleep positions very frequently (which may indicate that patient 4 has difficulty breathing), processing circuitry of system 2 may automatically increase an angle of the adjustable bed to increase the sleep angle of patient 4.” (Par. 96 of applicant’s spec.). However, this merely further recites the function, without providing additional detail in regards to the structures that are involved with the indicated function. Is the bed electronic? How does the bed move? How does the angle increase? Does the bed have a processor? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. 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. For examination purposes, this will be interpreted as any generic computational structure connected to a bed.
Claim 12 limitation “adjustable bed is configured to elevate an upper body of the patient relative to a lower body of the patient” 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. It is unclear as to the manner in which the bed is adjustable to elevate an upper body of the patient relative to a lower body of the patient. The applicant’s specification does state “processing circuitry of system 2 may automatically regulate an angle of an adjustable bed on which patient 4 is sleeping based on the second posture state, where the adjustable bed is configured to elevate an upper body of patient 4 relative to a lower body of patient 4. For example, if at a first sleep angle patient 4 is changing sleep positions very frequently (which may indicate that patient 4 has difficulty breathing), processing circuitry of system 2 may automatically increase an angle of the adjustable bed to increase the sleep angle of patient 4.” (Par. 96 of applicant’s spec.). However, this merely further recites the function, without providing additional detail in regards to the structures that are involved with the indicated function. Is the bed electronic? How does the bed move? How does the angle of the bed change? Does the bed have a processor? Is the bed a single unitary structure that bends? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. 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. For examination purposes, this will be interpreted as any generic computational structure connected to a bed.
Claim 13 limitation “processing circuitry is configured to determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model” 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. It is unclear as to the structure of the machine learning or probability model in the processing circuitry that performs the indicated function. The applicant’s specification does state “may be inputs to a machine learning model and/or probability model configured to determine a heart failure risk (or other health condition) of patient 4. For example, techniques for applying physiological parameters to a Bayesian Belief Network or other probability model, such as deep learning convolution or long short term neural networks” (Par. 40 of applicant’s spec.). However, this merely further recites the existence of differing machine learning techniques without identifying the manner in which the techniques are used by the applicant. For example, the applicant’s specification lacks sufficient detail in regards to the specific weights, biases, or layers in the model itself or the manner in which the model is trained. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. 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. For examination purposes, this will be interpreted as a generic computational structure with a generic algorithm capable of the indicated function
Claim 14 limitation “processing circuitry is configured to determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model” 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. It is unclear as to the structure of the machine learning or probability model in the processing circuitry that performs the indicated function. The applicant’s specification does state “may be inputs to a machine learning model and/or probability model configured to determine a heart failure risk (or other health condition) of patient 4. For example, techniques for applying physiological parameters to a Bayesian Belief Network or other probability model, such as deep learning convolution or long short term neural networks” (Par. 40 of applicant’s spec.). However, this merely further recites the existence of differing machine learning techniques without identifying the manner in which the techniques are used by the applicant. For example, the applicant’s specification lacks sufficient detail in regards to the specific weights, biases, or layers in the model itself or the manner in which the model is trained. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. 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. For examination purposes, this will be interpreted as a generic computational structure with a generic algorithm capable of the indicated function
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.
Claims 2-15 are dependent on claim 1, and as such are also rejected.
Claims 17-19 are dependent on claim 16, and as such are also rejected.
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 1-11 and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards a judicial exception without significantly more. These claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception or that are sufficient to amount to significantly more than the judicial exception.
Step 1 of the subject matter eligibility test
Claims 1, 16, and 20 are directed towards a system, device, and method respectively, which describes one of the four statutory categories of patentable subject matter.
Step 2A of the subject matter eligibility test
Prong 1: Claims 1 and 16 recite the abstract idea of a mental process as follows: “responsive to one or more of a first signal…” “… satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold, determine a first posture state based on the first signal”, “responsive to one or more of a second signal satisfying a second threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold, determine a second posture state based on the second signal”, “determine a heart failure risk based on the first posture state and the second posture state”, and “generate output based at least in part on the heart failure risk”.
The responsive to one or more of a first signal satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold, determining a first posture state based on the first signal, responsive to one or more of a second signal satisfying a second threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold, determining a second posture state based on the second signal, determining a heart failure risk based on the first posture state and the second posture state, and generating output based at least in part on the heart failure risk can be practically performed by the human mind, with the aid of a pen and paper, but for performance on a generic processor, in a computer environment, or merely using the computer as a tool to perform the steps.
A person of ordinary skill in the art could reasonably determine a first posture state based on being handed a piece of paper with first signal data that satisfies a first threshold or a first heart rate that satisfies a first heart rate threshold mentally or with a pen and paper. A person of ordinary skill in the art could reasonably determine a second posture state based on being handed a piece of paper with second signal data that satisfies a second threshold or a second heart rate that satisfies a second heart rate threshold mentally or with a pen and paper. A person of ordinary skill in the art could reasonably mentally make a determination regarding heart failure risk based on being handed a piece of paper with first and second posture state data. A person of ordinary skill in the art could reasonably generate an output verbally, or with a generic computer based on being handed a piece of paper with a heart failure risk.
There is currently nothing to suggest an undue level of complexity in the determining or generating steps. Therefore, a person would be able to practically be able to perform the generating and determining steps mentally or with the aid of pen and paper.
Prong Two: Claims 1 and 16 do not recite additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., processing circuitry), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. an implantable medical device with an accelerometer, sensing circuitry, and processing circuitry, an accelerometer, sensing circuitry).
Prong 1: Claim 20 recites the abstract idea of a mental process as follows: “responsive to one or more of a first signal…” “…satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold, determining…” “…a first posture state based on the first signal”, “responsive to one or more of a second signal satisfying a second threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold, determining…” “… a second posture state based on the second signal”, “determining…” “…a heart failure risk based on the first posture state and the second posture states”, and “generating…” “… output based at least in part on the heart failure risk”.
The responsive to one or more of a first signal satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold, determining a first posture state based on the first signal, responsive to one or more of a second signal satisfying a second threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold, determining a second posture state based on the second signal, determining a heart failure risk based on the first posture state and the second posture states, and generating output based at least in part on the heart failure risk can be practically performed by the human mind, with the aid of a pen and paper, but for performance on a generic processor, in a computer environment, or merely using the computer as a tool to perform the steps.
A person of ordinary skill in the art could reasonably determine a first posture state based on being handed a piece of paper with first signal data that satisfies a first threshold or a first heart rate that satisfies a first heart rate threshold mentally or with a pen and paper. A person of ordinary skill in the art could reasonably determine a second posture state based on being handed a piece of paper with second signal data that satisfies a second threshold or a second heart rate that satisfies a second heart rate threshold mentally or with a pen and paper. A person of ordinary skill in the art could reasonably mentally make a determination regarding heart failure risk based on being handed a piece of paper with first and second posture state data. A person of ordinary skill in the art could reasonably generate an output verbally, or with a generic computer based on being handed a piece of paper with a heart failure risk.
There is currently nothing to suggest an undue level of complexity in the determining or generating steps. Therefore, a person would be able to practically be able to perform the generating and determining steps mentally or with the aid of pen and paper.
Prong Two: Claim 20 does not recite additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. processing circuitry).
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “sensing, by an accelerometer of an implantable medical device, and posture of a patient,”, “sensing, by sensing circuitry of the implantable medical device, cardiac activity of a patient”, an implantable medical device with an accelerometer and sensing circuitry)).
For claims 1, 16, and 20. The additional elements merely serve to gather data to be used by the abstract idea. The processing circuitry, implantable device, accelerometer, and sensing circuitry are merely used as a pre-solution step of necessary data gathering to be used by the abstract idea. The sensing is merely used as additional types data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing that is performed remains in the abstract realm, i.e. the gathered data is not used for a treatment or meaningful purpose. Additionally, there is no overall improvement to existing technology present. The mental process merely functions on generic computer elements that do not change the functionality of the device itself. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test for Claims 1, 16, and 20
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
An implantable device with an accelerometer, processing circuitry, and sensing circuitry as disclosed by Soykan (US Pub. No. 20120277546) hereinafter Soykan “The medical device can be a unit with no leads or may contain leads and external sensors. Units with no leads such as the Medtronic Reveal.RTM. device, or other known devices familiar to those of ordinary skill…” “…device can contain a power source such as a battery, a computing hardware, a data storage unit such as electronic memory and communication hardware or related systems.” (Par. 134) and Ziegler et al (“Real-World Experience with Insertable Cardiac Monitors to Find Atrial Fibrillation in Cryptogenic Stroke”, 2015)(Cited 48 times) “The Reveal LINQ™ ICM measures 44.8 mm long by 7.2 mm wide by 4.0 mm thick, has a volume of 1.2 cm3, and weighs 2.5 g. Electrodes on the ends of the device record ECG signals and an embedded accelerometer measures patient activity. The device has a dedicated AF detection algorithm (described below) from which the incidence and duration of AF episodes can be determined. The device can store up to 14 AF episodes with electrocardiogram (ECG) data after which the earliest episode gets overwritten by newer episodes….” (Page 176, Col. 1)
are all well-understood, routine, and conventional.
Claims 2-11, 13-15, and 17-19 do not include additional elements, alone or in combination that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) as all of the elements are directed to the further describing of the abstract idea, pre-solution activities, and computer implementation.
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely further describe the abstract idea:
determine the heart failure risk based on a change in the second posture state over a period of time (Claim 2),
wherein the period of time comprises a plurality of days (Claim 3),
determine a metric based on the first posture state and the second posture state (Claim 4)(Examiner's Note: A person of ordinary skill in the art could reasonably determine a metric based on receiving a piece of paper with a first posture state and second posture state),
determine the heart failure risk based on the metric (Claim 4),
wherein the metric is a sleep angle (Claim 5),
determine the metric based on a difference between the first posture state and the second posture state (Claim 6),
wherein the first time is during a wake phase of the patient, and wherein the second time is during a sleep phase of the patient (Claim 7),
wherein the first threshold is greater than the second threshold, wherein the first heart rate threshold is greater than the second heart rate threshold (Claim 8),
determine the heart failure risk further based on the parameter indicative of heart failure (Claim 9),
the output comprises an indication of the health failure risk (Claim 10),
the output further comprises an indication of a pulmonary condition risk (Claim 11),
determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model (Examiner's Note: A person of ordinary skill in the art could reasonably determine a heart failure risk by applying a first and second posture state to a probability model with a generic computer based on receiving a piece of paper with first and second posture states) (Claim 13),
determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model (Claim 14),
determine the heart failure risk based on a change in the second posture state over a period of time (Claim 17).
Further describe the pre-solution activity (or structure used for such activity):
Processing circuitry (Claims 2, 4, 6, 9, 13-15, 17),
Electrodes (Claims 9, 15, and 18),
An insertable cardiac monitor (Claim 15, 18, and 19),
a housing configured for subcutaneous implantation in the patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width (Claim 19),
two electrodes (Claim 19).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
Processing Circuitry, electrodes, and an insertable cardiac monitor as disclosed by Soykan and Ziegler above
a housing configured for subcutaneous implantation in the patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width and two electrodes as disclosed by Ziegler above.
are all well-understood, routine, and conventional.
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, data gathering, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements improves the functioning of a mobile device, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The claims are generally directed towards an implantable device with an accelerometer, sensing circuitry, and processing circuitry. The processing circuitry is configured to determine a first posture stated based on a first signal satisfying a first threshold and second posture stated based on a second signal satisfying a second threshold. The processing circuitry is further configured to determine a heart failure risk based on the first and second posture states and generate an output.
Claim(s) 1-10 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aranda (US Pub. No. 20200345240) hereinafter Aranda, and further in view of Lee (US Pub. No. 20190365290) hereinafter Lee.
Regarding claim 1, Aranda discloses A system comprising (Fig. 1, Par. 43, “FIG. 1 illustrates the environment of an example medical device system 2 in conjunction with a patient 4 and a heart 6, in accordance with an apparatus and method of certain examples described herein.”):
an implantable medical device (Par. 38, 43-44, IMD – 10 (implantable medical device)) comprising:
an accelerometer configured to sense activity and posture of a patient (Par. 46, “the one or more sensors may include one or more accelerometers or other sensors configured to detect the at least one first signal, which may be at least one signal indicative of one or more aspects of an activity state of patient 4, such as activity level, posture, and/or respiration rate. As discussed in further detail below with respect to FIGS. 3-4B, such one or more accelerometers may be enclosed within a housing of IMD 10. The one or more accelerometers may comprise one or more three-axis accelerometers and may be a component of IMD 10 or a component of another medical device of medical device system 2.”) (Par. 45, “Medical device system 2 may include one or more sensors (e.g., for sensing an activity state of patient 4 and/or cardiac function of patient 4).”); and
sensing circuitry configured to sense cardiac activity of a patient (Par. 47, “the one or more sensors may include a plurality of electrodes, which may be positioned on the housing of IMD 10. The plurality of electrodes may be configured to detect the at least one second signal, which may be a cardiac electrogram. The processing circuitry may determine the values of the at least one HBV metric based on the at least one second signal.”) (Par. 107, “processing circuitry 50 then determines a first value of the at least one HBV metric of patient…” “…the at least one second signal may be a cardiac electrogram signal received by processing circuitry 50 from electrodes 16A and 16B or any other combination of at least two electrodes on IMD 10.”); and
processing circuitry configured to (Par. 85, “FIG. 3 is a functional block diagram illustrating an example configuration of IMD 10 of FIGS. 1 and 2. As shown in FIG. 3, IMD 10 includes processing circuitry 50…”) (Par. 86, “Processing circuitry 50 may include fixed function circuitry and/or programmable processing circuitry…”) (Par. 105, “FIG. 6 is a flow diagram illustrating an example technique for determining, by processing circuitry of medical device system 2 (e.g., processing circuitry 50 of IMD 10), a heart failure status of patient 4 based on a difference between a first value of at least one HBV metric of patient 4 and a second value of the at least one HBV metric of patient…”):
responsive to one or more of a first signal from the accelerometer satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold (Fig. 6, step 110, Par. 106, “processing circuitry 50 determines that an activity state of patient 4 satisfies at least one inactivity criterion based on at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4, or a time of day…”), determine a first posture state based on the first signal (Fig. 6, step 110-112)(Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…” “…the at least one inactivity criterion may be associated with patient 4 lying down and/or being asleep.”)(Par. 107, “After determining that the activity state of patient 4 satisfies the at least one inactivity criterion, processing circuitry 50 then determines a first value of the at least one HBV metric of patient 4 while the activity state of patient 4 satisfies the at least one inactivity criterion…”), wherein the accelerometer outputs the first signal at a first time (Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…”), and wherein the sensing circuitry senses the first set of cardiac activity data at the first time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”);
responsive to one or more of a second signal satisfying a threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state…”) (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate…”), determine a second posture state based on the second signal (Fig. 6, step 114-116)(Par. 108, “processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)…”) (Par. 108, “in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state. Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric while the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one second signal (116)…”), wherein the accelerometer outputs the second signal at a second time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”) (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)”), and wherein the sensing circuitry senses the second set of cardiac activity data at the second time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”) (Par. 108, “Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric…”);
determine a heart failure risk based on the first posture state and the second posture state (Fig. 6, step 120)(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120). Processing circuitry 50 may determine the heart failure status of patient 4 by determining whether the difference between the first and second values of the at least one HBV metric satisfies an HBV difference threshold value associated with a change in the heart failure status of patient 4, which may be stored in baseline/threshold tables 64 of memory 56.”); and
generate output based at least in part on the heart failure risk (Fig. 6, step 122) (Par. 114, “Processing circuitry then transmits the health status of patient 4 to a remote computer, such as external device 12 (122)…”).
Aranda fails to explicitly disclose responsive to one or more of a second signal satisfying a second threshold (Examiner's Note: Aranda fails to explicitly state that a second signal satisfies a separate, second threshold).
Aranda does disclose responsive to one or more of a second signal satisfying a threshold (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state…”) (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate…”).
Lee teaches a plurality of thresholds (Par. 182, “The processor may compare the scalar dot product to a set of thresholds (514). In some examples the threshold comparison may indicate that the patient is in a lying down posture (516). If the patient is in a lying down posture (YES of 516) the processor may use the heuristic sign (positive or negative) of the posture vector signals (ax, ay, az) and magnitude comparisons to classify which lying down posture that patient is in. For example, supine, prone, right-side up or left-side up (518).”) (Par. 183, “If the patient is not in a lying down posture (NO of 516), the processor may compare the scalar dot product to one or more thresholds to determine which of the upright postures the patient is in (520). Some example upright postures may include standing upright, upside down or sitting. For either lying down or upright postures, the processor may store the information at a memory location (480).”) (Fig. 11, (multiple thresholds)) (Par. 184, “The determine posture (500) steps may also be described in terms of a logic flow, similar to a computer program. The values in the below logic flow description (e.g. 0.5, 0.85) are for illustration purposes only. Other thresholds may be equally valid depending on the compensation, programming, selected hardware, accelerometer characteristics and other parameters…”).
Aranda and Lee are considered to be analogous art to the claimed invention as they are involved with posture related devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Aranda with that of Lee to include responsive to one or more of a second signal satisfying a second threshold through the combination of references and addition of a second threshold as it would have yielded the predictable result of enabling the identification of multiple user postures (Lee (Par. 182-184)).
Regarding claim 16, Aranda discloses An implantable medical device (Par. 38, 43-44, IMD – 10 (implantable medical device)) comprising:
an accelerometer configured to sense activity and posture of a patient (Par. 46, “the one or more sensors may include one or more accelerometers or other sensors configured to detect the at least one first signal, which may be at least one signal indicative of one or more aspects of an activity state of patient 4, such as activity level, posture, and/or respiration rate. As discussed in further detail below with respect to FIGS. 3-4B, such one or more accelerometers may be enclosed within a housing of IMD 10. The one or more accelerometers may comprise one or more three-axis accelerometers and may be a component of IMD 10 or a component of another medical device of medical device system 2.”) (Par. 45, “Medical device system 2 may include one or more sensors (e.g., for sensing an activity state of patient 4 and/or cardiac function of patient 4).”);
sensing circuitry configured to sense cardiac activity of a patient (Par. 47, “the one or more sensors may include a plurality of electrodes, which may be positioned on the housing of IMD 10. The plurality of electrodes may be configured to detect the at least one second signal, which may be a cardiac electrogram. The processing circuitry may determine the values of the at least one HBV metric based on the at least one second signal.”) (Par. 107, “processing circuitry 50 then determines a first value of the at least one HBV metric of patient…” “…the at least one second signal may be a cardiac electrogram signal received by processing circuitry 50 from electrodes 16A and 16B or any other combination of at least two electrodes on IMD 10.”); and
processing circuitry configured to (Par. 85, “FIG. 3 is a functional block diagram illustrating an example configuration of IMD 10 of FIGS. 1 and 2. As shown in FIG. 3, IMD 10 includes processing circuitry 50…”) (Par. 86, “Processing circuitry 50 may include fixed function circuitry and/or programmable processing circuitry…”) (Par. 105, “FIG. 6 is a flow diagram illustrating an example technique for determining, by processing circuitry of medical device system 2 (e.g., processing circuitry 50 of IMD 10), a heart failure status of patient 4 based on a difference between a first value of at least one HBV metric of patient 4 and a second value of the at least one HBV metric of patient…”):
responsive to one or more of a first signal from the accelerometer satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold (Fig. 6, step 110, Par. 106, “processing circuitry 50 determines that an activity state of patient 4 satisfies at least one inactivity criterion based on at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4, or a time of day…”), determine a first posture state based on the first signal (Fig. 6, step 110-112)(Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…” “…the at least one inactivity criterion may be associated with patient 4 lying down and/or being asleep.”)(Par. 107, “After determining that the activity state of patient 4 satisfies the at least one inactivity criterion, processing circuitry 50 then determines a first value of the at least one HBV metric of patient 4 while the activity state of patient 4 satisfies the at least one inactivity criterion…”), wherein the accelerometer outputs the first signal at a first time (Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…”), and wherein the sensing circuitry senses the first set of cardiac activity data at the first time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”);
responsive to one or more of a second signal satisfying a threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state…”) (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate…”), determine a second posture state based on the second signal (Fig. 6, step 114-116)(Par. 108, “processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)…”) (Par. 108, “in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state. Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric while the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one second signal (116)…”), wherein the accelerometer outputs the second signal at a second time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”) (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)”), and wherein the sensing circuitry senses the second set of cardiac activity data at the second time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”) (Par. 108, “Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric…”);
determine a heart failure risk based on the first posture state and the second posture state (Fig. 6, step 120)(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120). Processing circuitry 50 may determine the heart failure status of patient 4 by determining whether the difference between the first and second values of the at least one HBV metric satisfies an HBV difference threshold value associated with a change in the heart failure status of patient 4, which may be stored in baseline/threshold tables 64 of memory 56.”); and
generate output based at least in part on the heart failure risk (Fig. 6, step 122) (Par. 114, “Processing circuitry then transmits the health status of patient 4 to a remote computer, such as external device 12 (122)…”).
Aranda fails to explicitly disclose responsive to one or more of a second signal satisfying a second threshold (Examiner's Note: Aranda fails to explicitly state that a second signal satisfies a separate, second threshold).
Aranda does disclose responsive to one or more of a second signal satisfying a threshold (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state…”) (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate…”).
Lee teaches a plurality of thresholds (Par. 182, “The processor may compare the scalar dot product to a set of thresholds (514). In some examples the threshold comparison may indicate that the patient is in a lying down posture (516). If the patient is in a lying down posture (YES of 516) the processor may use the heuristic sign (positive or negative) of the posture vector signals (ax, ay, az) and magnitude comparisons to classify which lying down posture that patient is in. For example, supine, prone, right-side up or left-side up (518).”) (Par. 183, “If the patient is not in a lying down posture (NO of 516), the processor may compare the scalar dot product to one or more thresholds to determine which of the upright postures the patient is in (520). Some example upright postures may include standing upright, upside down or sitting. For either lying down or upright postures, the processor may store the information at a memory location (480).”) (Fig. 11, (multiple thresholds)) (Par. 184, “The determine posture (500) steps may also be described in terms of a logic flow, similar to a computer program. The values in the below logic flow description (e.g. 0.5, 0.85) are for illustration purposes only. Other thresholds may be equally valid depending on the compensation, programming, selected hardware, accelerometer characteristics and other parameters…”).
Aranda and Lee are considered to be analogous art to the claimed invention as they are involved with posture related devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Aranda with that of Lee to include responsive to one or more of a second signal satisfying a second threshold through the combination of references and addition of a second threshold as it would have yielded the predictable result of enabling the identification of multiple user postures (Lee (Par. 182-184)).
Regarding claim 20, Aranda discloses A method comprising:
sensing, by an accelerometer of an implantable medical device (Par. 38, 43-44, IMD – 10 (implantable medical device)) (Par. 46, “the one or more sensors may include one or more accelerometers or other sensors configured to detect the at least one first signal, which may be at least one signal indicative of one or more aspects of an activity state of patient 4, such as activity level, posture, and/or respiration rate. As discussed in further detail below with respect to FIGS. 3-4B, such one or more accelerometers may be enclosed within a housing of IMD 10. The one or more accelerometers may comprise one or more three-axis accelerometers and may be a component of IMD 10 or a component of another medical device of medical device system 2.”) (Par. 45, “Medical device system 2 may include one or more sensors (e.g., for sensing an activity state of patient 4 and/or cardiac function of patient 4).”), and posture of a patient (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture”)(Fig. 6, step 110);
sensing, by sensing circuitry of the implantable medical device (Par. 47, “the one or more sensors may include a plurality of electrodes, which may be positioned on the housing of IMD 10. The plurality of electrodes may be configured to detect the at least one second signal, which may be a cardiac electrogram. The processing circuitry may determine the values of the at least one HBV metric based on the at least one second signal.”) (Par. 107, “processing circuitry 50 then determines a first value of the at least one HBV metric of patient…” “…the at least one second signal may be a cardiac electrogram signal received by processing circuitry 50 from electrodes 16A and 16B or any other combination of at least two electrodes on IMD 10.”), cardiac activity of a patient (Par. 107, “processing circuitry 50 then determines a first value of the at least one HBV metric of patient…” “…the at least one second signal may be a cardiac electrogram signal received by processing circuitry 50 from electrodes 16A and 16B or any other combination of at least two electrodes on IMD 10.”);
responsive to one or more of a first signal from the accelerometer satisfying a first threshold or a first heart rate determined from a first set of cardiac activity data satisfying a first heart rate threshold (Fig. 6, step 110, Par. 106, “processing circuitry 50 determines that an activity state of patient 4 satisfies at least one inactivity criterion based on at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4, or a time of day…”), determining, by processing circuitry, a first posture state based on the first signal (Fig. 6, step 110-112)(Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…” “…the at least one inactivity criterion may be associated with patient 4 lying down and/or being asleep.”)(Par. 107, “After determining that the activity state of patient 4 satisfies the at least one inactivity criterion, processing circuitry 50 then determines a first value of the at least one HBV metric of patient 4 while the activity state of patient 4 satisfies the at least one inactivity criterion…”), wherein the accelerometer outputs the first signal at a first time (Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…”), and wherein the sensing circuitry senses the first set of cardiac activity data at the first time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”);
responsive to one or more of a second signal satisfying a threshold or a second heart rate determined from a second set of cardiac activity data satisfying a second heart rate threshold (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state…”) (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate…”), determining, by the processing circuitry, a second posture state based on the second signal (Fig. 6, step 114-116)(Par. 108, “processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)…”) (Par. 108, “in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state. Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric while the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one second signal (116)…”), wherein the accelerometer outputs the second signal at a second time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”) (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)”), and wherein the sensing circuitry senses the second set of cardiac activity data at the second time (Par. 106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4,”) (Par. 108, “Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric…”);
determining, by the processing circuitry, a heart failure risk based on the first posture state and the second posture state (Examiner's Note: Interpreted in light of the applicant’s specification as a computational structure with an algorithm that outputs a metric based on posture changes, or equivalents thereof, as described on Par. 61, 62, and 70 of the disclosure filed on 07/25/2024)(Fig. 6, step 120)(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120). Processing circuitry 50 may determine the heart failure status of patient 4 by determining whether the difference between the first and second values of the at least one HBV metric satisfies an HBV difference threshold value associated with a change in the heart failure status of patient 4, which may be stored in baseline/threshold tables 64 of memory 56.”); and
generating, by the processing circuitry, output based at least in part on the heart failure risk (Fig. 6, step 122) (Par. 114, “Processing circuitry then transmits the health status of patient 4 to a remote computer, such as external device 12 (122)…”).
Aranda fails to explicitly disclose responsive to one or more of a second signal satisfying a second threshold (Examiner's Note: Aranda fails to explicitly state that a second signal satisfies a separate, second threshold).
Aranda does disclose responsive to one or more of a second signal satisfying a threshold (Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state…”) (Par. 106, “one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate…”).
Lee teaches a plurality of thresholds (Par. 182, “The processor may compare the scalar dot product to a set of thresholds (514). In some examples the threshold comparison may indicate that the patient is in a lying down posture (516). If the patient is in a lying down posture (YES of 516) the processor may use the heuristic sign (positive or negative) of the posture vector signals (ax, ay, az) and magnitude comparisons to classify which lying down posture that patient is in. For example, supine, prone, right-side up or left-side up (518).”) (Par. 183, “If the patient is not in a lying down posture (NO of 516), the processor may compare the scalar dot product to one or more thresholds to determine which of the upright postures the patient is in (520). Some example upright postures may include standing upright, upside down or sitting. For either lying down or upright postures, the processor may store the information at a memory location (480).”) (Fig. 11, (multiple thresholds)) (Par. 184, “The determine posture (500) steps may also be described in terms of a logic flow, similar to a computer program. The values in the below logic flow description (e.g. 0.5, 0.85) are for illustration purposes only. Other thresholds may be equally valid depending on the compensation, programming, selected hardware, accelerometer characteristics and other parameters…”).
Aranda and Lee are considered to be analogous art to the claimed invention as they are involved with posture related devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Aranda with that of Lee to include responsive to one or more of a second signal satisfying a second threshold through the combination of references and addition of a second threshold as it would have yielded the predictable result of enabling the identification of multiple user postures (Lee (Par. 182-184)).
Regarding claim 2, modified Aranda further discloses wherein the processing circuitry is configured to determine the heart failure risk based on a change in the second posture state over a period of time (Fig. 6, step 114-116) (Par. 108, “processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)…”) (Par. 108, “in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state. Processing circuitry 50 then determines, within a predetermined period of time after determining that the activity state of patient 4 no longer satisfies the at least one inactivity criterion, a second value of the at least one HBV metric while the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one second signal (116)…”) (Fig. 6, step 120) (Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120)...”).
Regarding claim 16, modified Aranda discloses the system of claim 2 above, which comprises the device of claim 16. As the claims are similar, claim 16 is rejected in the same manner as claim 2.
Regarding claim 3, modified Aranda further discloses wherein the period of time comprises a plurality of days (Aranda (Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period…”) (Par. 52 (multiple days))).
Regarding claim 4, modified Aranda further discloses wherein the processing circuitry is further configured to determine a metric based on the first posture state and the second posture state (Aranda (Fig. 6, step 110-118) (Par. 108, “processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)…” (determination of whether there is a change in activity state)) (Par.106, “at least one first signal received by processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110). The at least one inactivity criterion may be, in some examples, at least one of an activity level, posture, heart rate, or respiration rate of patient 4…” “…the at least one inactivity criterion may be associated with patient 4 lying down and/or being asleep.”)(Par. 107, “After determining that the activity state of patient 4 satisfies the at least one inactivity criterion, processing circuitry 50 then determines a first value of the at least one HBV metric of patient 4 while the activity state of patient 4 satisfies the at least one inactivity criterion…”)), wherein the processing circuitry is configured to determine the heart failure risk based on the metric (Aranda (Fig. 6, step 120)(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120). Processing circuitry 50 may determine the heart failure status of patient 4 by determining whether the difference between the first and second values of the at least one HBV metric satisfies an HBV difference threshold value associated with a change in the heart failure status of patient 4, which may be stored in baseline/threshold tables 64 of memory 56.”)).
Regarding claim 5, modified Aranda further discloses wherein the metric is a sleep angle (Aranda (Par. 108, “In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture…”)).
Regarding claim 6, modified Aranda further discloses wherein the processing circuitry is configured to determine the metric based on a difference between the first posture state and the second posture state (Aranda (Fig. 6, step 110-118) (Par. 108, “In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture…”) (Par. 108, “processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114)…” (determination of whether there is a change in activity state))).
Regarding claim 7, modified Aranda fails to explicitly disclose the limitations of the claim.
However, Aranda does teach in an example wherein the time is during a wake phase of the patient, and wherein the time is during a sleep phase of the patient (Aranda (Par. 106, “the at least one inactivity criterion may be associated with patient 4 lying down and/or being asleep.”)(Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state.”)).
Aranda further teaches measurements during a plurality of activity states (Aranda (Par. 53, “the processing circuitry may determine a baseline difference between a first value of the at least one HBV metric determined while the activity state of patient 4 satisfies at least one inactivity criterion (e.g., during a sleep state) and a second value of the at least one HBV metric determined while the activity state of patient 4 no longer satisfies the inactivity criterion (e.g., soon after waking)…”) (Par. 106, “the at least one inactivity criterion may be associated with patient 4 lying down and/or being asleep.”)(Par. 108, “After determining the first value of the at least one HBV metric, processing circuitry 50 then determines that the activity state of patient 4 no longer satisfies the at least one inactivity criterion based on the at least one first signal received by processing circuitry from sensors 58 (114). In examples in which the at least one inactivity criterion is associated with patient 4 lying down and/or being asleep, the determination that the activity state of patient 4 no longer satisfies the at least one inactivity criterion may comprise a determination that patient 4 is in an upright posture and/or has awakened from a sleep state.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Aranda and Lee with an example of Aranda to include wherein the first time is during a wake phase of the patient, and wherein the second time is during a sleep phase of the patient through the combination of examples and switching the first time to being during a wake phase and the second time to be during a sleep phase as measurements during different activity states are known (Aranda (Par. 53, 106, 108)) and it would have yielded the same or similar result of taking measurements between different activity states (Aranda (Par. 108)).
Regarding claim 8, modified Aranda fails to explicitly disclose the limitations of the claim.
However, Aranda does disclose wherein the first threshold is greater (Aranda (Par. 108 (inactivity threshold differences))), wherein the first heart rate threshold is greater than the second heart rate threshold (Examiner's Note: Interpreted under 112b as indicated above).
Lee further teaches a plurality of thresholds (Par. 182, “The processor may compare the scalar dot product to a set of thresholds (514). In some examples the threshold comparison may indicate that the patient is in a lying down posture (516). If the patient is in a lying down posture (YES of 516) the processor may use the heuristic sign (positive or negative) of the posture vector signals (ax, ay, az) and magnitude comparisons to classify which lying down posture that patient is in. For example, supine, prone, right-side up or left-side up (518).”) (Par. 183, “If the patient is not in a lying down posture (NO of 516), the processor may compare the scalar dot product to one or more thresholds to determine which of the upright postures the patient is in (520). Some example upright postures may include standing upright, upside down or sitting. For either lying down or upright postures, the processor may store the information at a memory location (480).”) (Fig. 11, (multiple thresholds)) (Par. 184, “The determine posture (500) steps may also be described in terms of a logic flow, similar to a computer program. The values in the below logic flow description (e.g. 0.5, 0.85) are for illustration purposes only. Other thresholds may be equally valid depending on the compensation, programming, selected hardware, accelerometer characteristics and other parameters…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Aranda and Lee with that of Lee to include wherein the first threshold is greater than the second threshold, wherein the first heart rate threshold is greater than the second heart rate threshold for the reasoning as indicated in claim 1 above.
Regarding claim 9, modified Aranda further discloses wherein the implantable medical device further comprises a set of electrodes configured to sense a parameter indicative of heart failure (Aranda (Par. 47, “the one or more sensors may include a plurality of electrodes, which may be positioned on the housing of IMD 10. The plurality of electrodes may be configured to detect the at least one second signal, which may be a cardiac electrogram. The processing circuitry may determine the values of the at least one HBV metric based on the at least one second signal.”)), wherein the processing circuitry is configured to determine the heart failure risk further based on the parameter indicative of heart failure (Aranda(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period…”) (Par. 106, “processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110)…”) (Par. 107, “one or more of electrodes 16A, 16B (112). For example, the at least one second signal may be a cardiac electrogram signal received by processing circuitry 50 from electrodes 16A and 16B or any other combination of at least two electrodes on IMD 10.”).
Regarding claim 9, modified Aranda further discloses wherein the output comprises an indication of the health failure risk (Par. 114, “heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization. Processing circuitry then transmits the health status of patient 4 to a remote computer, such as external device 12 (122). In some examples, processing circuitry 50 may transmit the heart failure status of patient 4 to the remote computer each time processing circuitry 50 determines the heart failure status of patient 4. In other examples, processing circuitry 50 may transmit the heart failure status of patient 4 to the remote computer less frequently, such as weekly or at any other suitable interval”).
Regarding claim 13, modified Aranda further discloses wherein the processing circuitry is configured to determine the heart failure risk by applying the first posture state and the second posture state to at least one of a machine learning model or a probability model (Aranda (Fig. 6, step 120)(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120). Processing circuitry 50 may determine the heart failure status of patient 4 by determining whether the difference between the first and second values of the at least one HBV metric satisfies an HBV difference threshold value associated with a change in the heart failure status of patient 4, which may be stored in baseline/threshold tables 64 of memory 56.”)(Examiner's Note: Interpreted as indicated in the 112b rejection above)).
Regarding claim 14, modified Aranda further discloses wherein the processing circuitry is configured to determine the heart failure risk by applying a metric determined based on the first and second posture states to at least one of a machine learning model or a probability model (Aranda (Fig. 6, step 120)(Par. 114, “Processing circuitry 50 may repeat steps 110-120 to periodically determine updated heart failure statuses of patient 4 such as daily, weekly, monthly, or at any other suitable period. In some examples, the heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization…”) (Par. 111, “After determining the first and second values of the at least one HBV metric of patient 4, processing circuitry 50 determines a difference between the first and second values of the at least one HBV metric (118) and determines a heart failure status of patient 4 based on the difference (120). Processing circuitry 50 may determine the heart failure status of patient 4 by determining whether the difference between the first and second values of the at least one HBV metric satisfies an HBV difference threshold value associated with a change in the heart failure status of patient 4, which may be stored in baseline/threshold tables 64 of memory 56.”)(Examiner's Note: Interpreted as indicated in the 112b rejection above)).
Regarding claim 15, modified Aranda further discloses wherein the implantable medical device comprises an insertable cardiac monitor (Aranda (Par. 44, “In some examples, IMD 10 may take the form of a Reveal LINQ™ Insertable Cardiac Monitor (ICM), available from Medtronic plc, of Dublin, Ireland. External device 12 may be a computing device configured for use in settings such as a home, clinic, or hospital, and may further be configured to communicate with IMD 10 via wireless telemetry.”)), and wherein the plurality of sensors comprises one or more electrodes (Aranda (Par. 47, “the one or more sensors may include a plurality of electrodes, which may be positioned on the housing of IMD 10. The plurality of electrodes may be configured to detect the at least one second signal, which may be a cardiac electrogram. The processing circuitry may determine the values of the at least one HBV metric based on the at least one second signal.”) (Par. 106, “processing circuitry 50 from sensors 58, such as from one or more accelerometers, one or more microphones, one or more pressure sensors, and/or one or more of electrodes 16A, 16B (110)…”)).
Regarding claim 18, modified Aranda discloses the system of claim 15 above, which comprises the device of claim 18. As the claims are similar, claim 18 is rejected in the same manner as claim 15.
Regarding claim 19, modified Aranda fails to explicitly disclose the limitations of the claim.
However, Aranda does teach in an example wherein the insertable cardiac monitor comprises:
a housing configured for subcutaneous implantation in the patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width (Aranda (Par. 68, “In the example shown in FIG. 2, IMD 10 is defined by a length L, a width W, and thickness or depth D. In this example, IMD 10 is in the form of an elongated rectangular prism in which length L is significantly greater than width W, and in which width W is greater than depth D…”) (Par. 69, “Overall, IMD 10 may have a length L of about 20-30 mm, about 40-60 mm, or about 45-60 mm. In some examples, the width W of first major surface 18 may range from about 3-10 mm, and may be any single width or range of widths between about 3-10 mm. In some examples, a depth D of IMD 10 may range from about 2-9 mm. In other examples, the depth D of IMD 10 may range from about 2-5 mm, and may be any single or range of depths from about 2-9 mm.”)),
wherein the one or more electrodes comprises:
a first electrode at or proximate to the first end of the housing (Aranda (Fig. 2, electrode – 16A) (Par. 72, “Integrated antenna 26 is located on the same major surface (e.g., first major surface 18) as electrode 16A, and may be an integral part of header assembly 32. In other examples, integrated antenna 26 may be formed on the major surface opposite from electrode 16A or may be incorporated within housing 14 of IMD 10.”) (Par. 67, “a proximal electrode 16A, and a distal electrode 16B. Housing 14 encloses electronic circuitry located inside the IMD 10, and protects the circuitry contained therein from fluids such as body fluids. In some examples, 14 may comprise first major surface 18, second major surface 20, proximal end 22, and distal end 24. Proximal electrode 16A and distal electrode 16B may be positioned near respective proximal and distal ends 22 and 24 of IMD 10,”)), and
a second electrode at or proximate to the second end of the housing (Aranda (Fig. 2, electrode 16B)(Par. 72, “Integrated antenna 26 is located on the same major surface (e.g., first major surface 18) as electrode 16A, and may be an integral part of header assembly 32. In other examples, integrated antenna 26 may be formed on the major surface opposite from electrode 16A or may be incorporated within housing 14 of IMD 10.”) (Par. 67, “a proximal electrode 16A, and a distal electrode 16B. Housing 14 encloses electronic circuitry located inside the IMD 10, and protects the circuitry contained therein from fluids such as body fluids. In some examples, 14 may comprise first major surface 18, second major surface 20, proximal end 22, and distal end 24. Proximal electrode 16A and distal electrode 16B may be positioned near respective proximal and distal ends 22 and 24 of IMD 10,”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Aranda and Lee with an example of Aranda to include wherein the insertable cardiac monitor comprises: a housing configured for subcutaneous implantation in the patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width, wherein the one or more electrodes comprises: a first electrode at or proximate to the first end of the housing, and a second electrode at or proximate to the second end of the housing through the combination of examples as differing housing configurations are known (Aranda (Par. 67-69)) and it would have yielded the same or similar results.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aranda in view of Lee as applied to claim 10 above, and further in view of An (US Pub. No. 20170281095) hereinafter An.
Aranda and Lee teach the system of claim 1 above
Regarding claim 11, modified Aranda fails to explicitly disclose the limitations of the claim.
Aranda does disclose wherein the output further comprises an indication of a condition risk (Aranda (Par. 114, “heart failure status of patient 4 may indicate a possibility that patient 4 may experience an adverse medical event within a certain period of time, such as a recurrence of symptoms, acute heart failure decompensation, or other adverse medical events that may require medical intervention such as hospitalization. Processing circuitry then transmits the health status of patient 4 to a remote computer, such as external device 12 (122). In some examples, processing circuitry 50 may transmit the heart failure status of patient 4 to the remote computer each time processing circuitry 50 determines the heart failure status of patient 4. In other examples, processing circuitry 50 may transmit the heart failure status of patient 4 to the remote computer less frequently, such as weekly or at any other suitable interval”)).
However, An teaches an indication of a pulmonary condition risk (Par. 56, “The risk stratifier circuit 232 may additionally use one or more signal metrics generated by the signal processor circuit 220 to determine a risk of future pulmonary disease such as COPD, asthma, pulmonary edema, or pulmonary hypertension, or to determine a risk of future renal disease such as chronic kidney failure. The signal metrics for assessing the risk of one disease (such as WHF) may also be used for assessing the risk of another different disease (such as COPD or acute kidney failure)…”).
Aranda, Lee, and An are considered to be analogous art to the claimed invention as they are involved with implantable medical devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Aranda and Lee with that of An to include wherein the output further comprises an indication of a pulmonary condition risk through the combination of references as different health conditions are known (An (Par. 56)) and it would have yielded the predictable result of providing additional disease information to the user.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aranda in view of Lee as applied to claim 1 above, and further in view of Bond (US Pub. No. 20220322839) hereinafter Bond.
Aranda and Lee teach the system of claim 1 above.
Regarding claim 12, modified Aranda fails to explicitly disclose the limitations of the claim.
However, Bond teaches wherein the processing circuitry is further configured to automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state (Par. 52, “Referring now to FIG. 12, there is shown a block diagram of a control circuit of an embodiment of the bed inclining system. In some embodiments, the bed inclining system 1000 comprises a remote electronic device 1800 configured to activate and control the lifting assembly 1200…”) (Par. 49, “Referring now to FIGS. 10-11, there is shown a rear view of a third embodiment of the bed inclining system in use and a side view of a third embodiment of the bed inclining system in use, respectively...”) (Par. 50, “As a result of the housing 1310 movement via the actuator and the position of the base frame 1100 at the head of the bed, the bed 6000 is configured to be moved between a level configuration and an inclined or raised configuration. In the level configuration, the bed is in a substantially horizontal position, and, in the inclined or raised configuration, the head end or foot end of the bed frame is raised from a floor and is raised relative to the opposite end of the bed frame.”), wherein the adjustable bed is configured to elevate an upper body of the patient relative to a lower body of the patient (Par. 52, “Referring now to FIG. 12, there is shown a block diagram of a control circuit of an embodiment of the bed inclining system. In some embodiments, the bed inclining system 1000 comprises a remote electronic device 1800 configured to activate and control the lifting assembly 1200…”) (Par. 49, “Referring now to FIGS. 10-11, there is shown a rear view of a third embodiment of the bed inclining system in use and a side view of a third embodiment of the bed inclining system in use, respectively...”) (Par. 50, “As a result of the housing 1310 movement via the actuator and the position of the base frame 1100 at the head of the bed, the bed 6000 is configured to be moved between a level configuration and an inclined or raised configuration. In the level configuration, the bed is in a substantially horizontal position, and, in the inclined or raised configuration, the head end or foot end of the bed frame is raised from a floor and is raised relative to the opposite end of the bed frame.”).
Aranda, Lee, and Bond are considered to be analogous art to the claimed invention as they are involved with posture related devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Aranda and Lee with that of Bond to include wherein the processing circuitry is further configured to automatically regulate an angle of an adjustable bed on which the patient is sleeping based on the second posture state of Aranda, wherein the adjustable bed is configured to elevate an upper body of the patient relative to a lower body of the patient through the combination of references as it would have yielded the predictable result of allowing for the optimization of the sleep of the patient (Bond (Par. 56)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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, Jason Sims can be reached at (571) 272-7540. 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.
/ARI S PADDA/Examiner, Art Unit 3791 /ADAM J EISEMAN/Primary Examiner, Art Unit 3791
Prosecution Insights