DETAILED ACTION
Applicant’s response filed 10/20/2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-4, 6-10, and 12-15 are pending and under consideration in this action. Claims 5 and 11 were canceled in the amendment filed 10/20/2025.
Priority
This application claims foreign priority from Indian Application No. 202121010972, filed 03/15/2021, as reflected in the filing receipt mailed 07/21/2022. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1-4, 6-10, and 12-15 is 03/15/2021.
Specification
The objection to the specification is withdrawn in view of Applicant’s amendment to the specification filed 10/20/2025.
Claim Objections
Withdrawn Objections
The objections to claims 2, 8 and 14 are withdrawn in view of Applicant’s amendments to the claims filed 10/20/2025.
Newly Recited Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites the phrase “when performing a activity” in line 11 of the claim, which should be corrected to “when performing an activity” for clarity.
This objection is newly recited and necessitated by claim amendment. Appropriate correction is required.
Withdrawn Rejections
35 U.S.C. 103
The rejection of claims 1-2, 4, 6-8, 10, and 12-14 under 35 U.S.C. 103 as being unpatentable over Mazumder et al, Jain et al., Neal et al., and Anselmino et al. is withdrawn in view of Applicant’s amendments to the claims filed 10/20/2025, and Applicant’s arguments were found persuasive (Applicant’s Remarks, Pg. 28-32). Specifically, Applicant incorporated the limitations from claims 5, 11, and 15, which were found to be free of the prior art in the Non-Final Office action dated 7/29/2025, into independent claims 1, 7, and 13.
The rejection of claims 3 and 9 under 35 U.S.C. 103 as being unpatentable over unpatentable over Mazumder et al, Jain et al., Neal et al., Anselmino et al., and Roy et al. is withdrawn for the same reasons as described for claims 1-2, 4, 6-8, 10, and 12-14 above.
Claim Rejections - 35 USC § 112(b)
Withdrawn Rejections
The rejection of claims 1-6, 9, 11, and 16 are withdrawn in view of Applicant’s amendments to the claims filed 10/20/2025 and Applicant’s arguments were found persuasive (Applicant’s Remarks, Pg. 16-19).
Newly Recited Rejections
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 6 and 12 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.
This rejection is newly recited and necessitated by claim amendment.
Claims 6 and 12 recites the limitation “the ECG signal from the wearable device worn by the subject” in lines 3-4 of the claims. There is insufficient antecedent basis for this limitation in the claim, since there is no prior mention of this phrase in claims 1 or 7, to which these claims depend. This rejection can be overcome by amendment of claims 6 and 12 to change their dependency to claims 2 and 8, respectively, which contains “an electrocardiogram (ECG) signal obtained from a wearable device worn by the subject”.
Claim Rejections - 35 USC § 101
Maintained Rejections
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 1-4, 6-10, and 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite both (1) mathematical concepts (mathematical relationships, formulas or equations, or mathematical calculations) and (2) mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Any newly recited portions herein are necessitated by claim amendment.
Step 1:
In the instant application, claims 1-4 and 6 are directed towards a method, claims 7-10 and 12 are directed towards a system, and claims 13-15 are directed towards a manufacture, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claims 1 and 7 recite a mathematical concept (i.e., using an algorithm to estimate input parameters) in “estimating a plurality of input parameters for a personalized cardiovascular hemodynamic model associated with a subject being monitored, the plurality of input parameters comprising: (i) Systemic Vascular Resistance (SVR), (ii) unstressed blood volume, (iii) total blood volume in a body of the subject, and (iv) heart rate of the subject”; a mathematical concept (i.e., using an algorithm to calculate the SVR levels) in “estimating the SVR using Metabolic EquivalenT (MET) levels associated with an activity level of the subject, wherein the step of estimating the SVR is represented as
R
s
(
t
)
=
R
s
(
0
)
R
s
(
0
)
M
E
T
(
t
)
*
e
t
-
M
E
T
(
t
)
τ
i
f
M
E
T
t
<
2.5
o
t
h
e
r
w
i
s
e
, wherein
R
s
(
0
)
represents the SVR at rest,
M
E
T
(
t
)
represents a metabolic equivalent of the activity performed at an tth time, and
τ
is a time constant, wherein the SVR corresponds to a section of the body of the subject”; mathematical concepts (i.e., calculating the SVR) in “wherein the SVR across the section is modulated based on the MET levels, depending on the activity being performed by the subject”, “wherein the SVR of remaining sections are considered constant or modulated by an autoregulation method”, and “wherein in order to simulate effect of the activity with a variation of the SVR, a systemic circulation part in the body is subdivided into three generic sections as an upper body, a middle body or a lower body of the subject”; a mathematical concept (i.e., using an algorithm to calculate updated blood volume) in “updating the unstressed blood volume estimated when the subject is at rest, using an autoregulation method, when an activity is performed by the subject”; a mathematical concept (i.e., using an equation to calculate neural firing frequency) in “converting the sensed aortic pressure into a neural firing frequency via afferent sympathetic pathways”; a mathematical concept (i.e., using equations to calculate sympathetic and parasympathetic nervous activities) in “generating sympathetic and parasympathetic nervous activities via a central nervous system and efferent pathway depending on the neural firing frequency”; a mathematical concept (i.e., using an algorithm to calculate additional blood demand) in “updating an additional blood demand representing the unstressed blood volume during the activity using the generated sympathetic and parasympathetic nervous activities”; and a mathematical concept (i.e., using an algorithm to calculate output cardiac parameters) in “estimating, via the personalized cardiovascular hemodynamic model, cardiac parameters including cardiac output, ejection fraction and mean arterial pressure, using the estimated plurality of input parameters”.
Claims 2, 8, and 14 recite a mental process (i.e., a judgement of input data to include in the model to make it personalized) in “personalizing/personalize a cardiovascular hemodynamic model to obtain the personalized cardiovascular hemodynamic model, the personalizing being based on one or more of (i) cardiac parameters obtained from an echocardiogram, (ii) an Electrocardiogram (ECG) signal obtained from a wearable device worn by the subject when performing the activity, and (iii) metadata of the subject including height and weight associated thereof”.
Claims 3 and 9 recites a mathematical calculation in “ wherein the step of estimating a plurality of input parameters comprises sequential activation of a right atrium ra, a left atrium la, a right ventricle rv and a left ventricle lv of the personalized cardiovascular hemodynamic model using compliance functions
C
r
a
(
t
)
,
C
l
a
(
t
)
,
C
r
v
(
t
)
and
C
l
v
(
t
)
, respectively”, a mathematical calculation in “the compliance function to actuate ra,
C
r
a
t
=
C
m
i
n
,
r
a
+
0.5
×
C
m
a
x
,
r
a
-
C
m
i
n
,
r
a
u
(
t
)
, wherein
u
t
=
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,
1
-
cos
2
π
t
-
T
a
T
-
T
a
,
0
≤
t
<
T
a
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a
≤
t
<
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,
C
m
i
n
,
r
a
and
C
m
a
x
,
r
a
are minimum and maximum values of the ra compliance,
u
(
t
)
is an activation function, time t is considered over a complete cardiac cycle,
T
a
is the start of a activation of ra and T is an end of the cardiac cycle”, a mathematical calculation in “the compliance function to actuate la,
C
l
a
t
=
C
m
i
n
,
l
a
+
0.5
×
C
m
a
x
,
l
a
-
C
m
i
n
,
l
a
u
(
t
-
d
l
a
)
, wherein
C
m
i
n
,
l
a
and
C
m
a
x
,
l
a
are minimum and maximum values of the la compliance and
d
l
a
represents a time delay between actuation of the ra and la”, and a mathematical calculation in “the compliance functions to actuate rv and lv are represented as
C
i
t
=
C
i
×
u
v
t
-
d
,
i
∈
l
v
,
r
v
wherein
u
v
t
=
0.5
-
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cos
π
1
T
1
,
0.5
+
0.5
cos
π
t
-
T
1
T
2
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T
1
,
0
,
0
≤
t
<
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1
T
1
≤
t
<
T
2
T
2
≤
t
<
T
,
C
i
;
i
∈
l
v
,
r
v
is a systolic compliance across lv or rv and is estimated as a ratio of R-peak and T-peak of the ECG signal,
u
v
(
t
)
is an activation function, d represents a time delay in the activation of lv or rv from ra, and T1 and T2 are systolic and diastolic activation time instances of the cardiac cycle, respectively”.
Claims 4 and 10 recite a mathematical concept (i.e., using an algorithm to calculate total blood volume) in “wherein the total blood volume is estimated using height and weight of the subject”.
Claims 6 and 12 recites a mathematical concept (i.e., using an algorithm to estimate data) and a mental process (i.e., a judgement of data to include) in “wherein the heart rate of the subject is estimated using (i) a Photoplethysmogram (PPG) signal and an accelerometer signal or (ii) the ECG signal, from the wearable device worn by the subject when performing the activity”.
Claim 13 recites a mathematical concept (i.e., using an algorithm to estimate input parameters) in “estimating a plurality of input parameters for a personalized cardiovascular hemodynamic model associated with a subject being monitored, the plurality of input parameters comprising: (i) Systemic Vascular Resistance (SVR), (ii) unstressed blood volume, (iii) total blood volume in a body of the subject using height and weight of the subject, and (iv) heart rate of the subject using (i) a Photoplethysmogram (PPG) signal and an accelerometer signal or (ii) an Electrocardiogram (ECG) signal, from a wearable device worn by the subject when performing an activity”; a mathematical concept (i.e., using an algorithm to calculate the SVR levels) in “estimating the SVR using Metabolic EquivalenT (MET) levels associated with an activity level of the subject, wherein the one or more processors are configured to estimate the SVR based on
R
s
(
t
)
=
R
s
(
0
)
R
s
(
0
)
M
E
T
(
t
)
*
e
t
-
M
E
T
(
t
)
τ
i
f
M
E
T
t
<
2.5
o
t
h
e
r
w
i
s
e
, wherein
R
s
(
0
)
represents the SVR at rest,
M
E
T
(
t
)
represents a metabolic equivalent of the activity performed at the tth time, and
τ
is a time constant”; mathematical concepts (i.e., calculating the SVR) in “wherein the SVR corresponds to a section of the body of the subject, wherein the SVR across the section is modulated based on the MET levels, depending on the activity being performed by the subject”, “wherein the SVR of remaining sections are considered constant or modulated by an autoregulation method”, and “wherein in order to simulate effect of the activity with a variation of the SVR, a systemic circulation part in the body is subdivided into three generic sections as an upper body, a middle body or a lower body of the subject”; a mathematical concept (i.e., using an algorithm to calculate updated blood volume) in “updating the unstressed blood volume estimated when the subject is at rest, using the autoregulation method, when the activity is performed by the subject”; a mathematical concept (i.e., using an equation to calculate neural firing frequency) in “converting the sensed aortic pressure into a neural firing frequency via afferent sympathetic pathways”; a mathematical concept (i.e., using equations to calculate sympathetic and parasympathetic nervous activities) in “generating sympathetic and parasympathetic nervous activities via a central nervous system and efferent pathway depending on the neural firing frequency”; a mathematical concept (i.e., using an algorithm to calculate additional blood demand) in “updating an additional blood demand representing the unstressed blood volume during the activity using the generated sympathetic and parasympathetic nervous activities”; and a mathematical concept (i.e., using an algorithm to calculate output cardiac parameters) in “estimating cardiac parameters including cardiac output, ejection fraction and mean arterial pressure, using the estimated plurality of input parameters”.
Claim 15 recites a mathematical calculation in “(a) estimate a plurality of input parameters comprises sequential activation of a right atrium ra, a left atrium la, a right ventricle rv and a left ventricle lv of the personalized cardiovascular hemodynamic model using compliance functions
C
r
a
(
t
)
,
C
l
a
(
t
)
,
C
r
v
(
t
)
and
C
l
v
(
t
)
, respectively”, a mathematical calculation in “the compliance function to actuate ra,
C
r
a
t
=
C
m
i
n
,
r
a
+
0.5
×
C
m
a
x
,
r
a
-
C
m
i
n
,
r
a
u
(
t
)
, wherein
u
t
=
0
,
1
-
cos
2
π
t
-
T
a
T
-
T
a
,
0
≤
t
<
T
a
T
a
≤
t
<
T
,
C
m
i
n
,
r
a
and
C
m
a
x
,
r
a
are minimum and maximum values of the ra compliance,
u
(
t
)
is an activation function, time t is considered over a complete cardiac cycle,
T
a
is a start of the activation of ra and T is an end of the cardiac cycle”, a mathematical calculation in “the compliance function to actuate la,
C
l
a
t
=
C
m
i
n
,
l
a
+
0.5
×
C
m
a
x
,
l
a
-
C
m
i
n
,
l
a
u
(
t
-
d
l
a
)
, wherein
C
m
i
n
,
l
a
and
C
m
a
x
,
l
a
are minimum and maximum values of the la compliance and
d
l
a
represents a time delay between actuation of the ra and la”, a mathematical calculation in “the compliance functions to actuate rv and lv are represented as
C
i
t
=
C
i
×
u
v
t
-
d
,
i
∈
l
v
,
r
v
wherein
u
v
t
=
0.5
-
0.5
cos
π
1
T
1
,
0.5
+
0.5
cos
π
t
-
T
1
T
2
-
T
1
,
0
,
0
≤
t
<
T
1
T
1
≤
t
<
T
2
T
2
≤
t
<
T
,
C
i
;
i
∈
l
v
,
r
v
is a systolic compliance across lv or rv and is estimated as a ratio of R-peak and T-peak of the ECG signal,
u
v
(
t
)
is an activation function, d represents a time delay in the activation of lv or rv from ra, and T1 and T2 are systolic and diastolic activation time instances of the cardiac cycle, respectively”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). The following claims recite limitations that equate to additional elements:
Claim 1 recites “via one or more hardware processors” and “sensing aortic pressure by baroreceptors located at carotid sinus and aortic arch”.
Claim 7 recites “one or more data storage devices operatively coupled to one or more hardware processors and configured to store instructions for execution via the one or more hardware processors” and “sensing aortic pressure by baroreceptors located at carotid sinus and aortic arch”.
Claim 13 recites “a computer program product comprising a non-transitory computer readable medium having a computer readable program embodied therein” and “sensing aortic pressure by baroreceptors located at carotid sinus and aortic arch”.
Regarding the above cited limitations in 1, 7, and 13 of (i) via one or more hardware processors, (ii) one or more data storage devices operatively coupled to one or more hardware processors and configured to store instructions for execution via the one or more hardware processors, and (iii) a computer program product comprising a non-transitory computer readable medium having a computer readable program embodied therein. These limitations require only a generic computer component, which does not improve computer technology. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the above cited limitations in claims 1, 7, and 13 of (iv) sensing aortic pressure by located at carotid sinus and aortic arch. These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exceptions of estimating, via the personalized cardiovascular hemodynamic mode!, cardiac parameters including cardiac output, ejection fraction and mean arterial pressure, using the estimated plurality of input parameters (see MPEP § 2106.04(d)). As such, claims 1-4, 6-10, and 12-15 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The instant claims recite same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in 1, 7, and 13 of (i) via one or more hardware processors, (ii) one or more data storage devices operatively coupled to one or more hardware processors and configured to store instructions for execution via the one or more hardware processors, and (iii) a computer program product comprising a non-transitory computer readable medium having a computer readable program embodied therein. These limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitations in claims 1, 7, and 13 of (iv) sensing aortic pressure by located at carotid sinus and aortic arch. These limitations when viewed individually and in combination, are WURC limitations as taught by Lau et al. (Aortic Baroreceptors Display Higher Mechanosensitivity than Carotid Baroreceptors. Front. Physiol. 7: 384 (2016); previously cited). Lau et al. teaches that the two arterial baroreceptors, the aortic and the carotid, are mechanical sensors that detect blood pressure changes with different sensitives (limitation (iv)) (Abstract).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-4, 6-10, and 12-15 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 10/20/2025 have been fully considered but they are not persuasive.
Applicant argues that amended claims 1, 7, and 13 are patent eligible as they integrate the judicial exception into a practical application in terms of improvement in the functionality of the computer by simulating the effect of the activity with a variation of the systemic vascular resistance (SVR), with a systemic circulation part in a body is subdivided into three generic sections. The SVR across the section is modulated based on MET levels and the SVR in the other sections are considered constant or modulated by an autoregulation method (Applicant’s Remarks, Pg. 19-21). Applicant’s arguments are not persuasive for the following reasons:
MPEP 2106.04(d)(II) recites:
The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).
The limitations of “estimating the SVR using Metabolic EquivalenT (MET) levels associated with an activity level of a subject...” and “wherein in order to simulate effect of the activity with a variation of the SVR, a systemic circulation part in the body is subdivided into three generic sections as an upper body, a middle body or a lower body of the subject” have been identified as judicial exceptions in Step 2A, Prong One above. The integration of a judicial exception into a practical application can only be achieved by additional elements, not by a limitation that recites a judicial exception. Thus, the recited limitation is not considered as an improvement in the functionality of a computer.
MPEP 2106.05(a)(I) recites:
"In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification's discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691."
Furthermore, no evidence has been presented to suggest that the computer itself has been altered in any way, i.e., by changing the functioning of a processor or by changing the way in which it stores or accesses memory. Nothing about the physical components of the computer nor the way the computer operates is changed by the limitations in claims 1, 7, and 13. Therefore, the use of a computer to perform the limitations in claims 1, 7, and 13 merely invokes a computer as a tool (see MPEP 2106.05(a)(I)). This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it improves the functionality of a computer by estimating the heart rate for a specific time-window by employing a noise cancellation technique, captured continuously via the wearable device (Applicant’s Remarks, Pg. 21). Applicant’s arguments are not persuasive for the following reasons:
The limitation of “estimate a plurality of input parameters for a personalized cardiovascular hemodynamic model associated with a subject being monitored, the plurality of input parameters comprising (i) Systemic Vascular Resistance (SVR), (ii) unstressed blood volume, (iii) total blood volume in a body of the subject using height and weight of the subject, and (iv) heart rate of the subject using (i) a Photoplethysmogram (PPG) signal and an accelerometer signal or (ii) an Electrocardiogram (ECG) signal, from a wearable device worn by the subject when performing an activity” in claim 13 has been identified as reciting a judicial exception in Step 2A, Prong One above. Similar limitations are recited in claims 1-2 and 7-8. Similar to the arguments directly above, the integration of judicial exceptions into practical applications can only be achieved by additional elements, not by limitations that recite judicial exceptions. Additionally, similar to the arguments directly above, there is no indication that the functioning of the computer has been improved, and thus the limitations merely invoke the computer as a tool. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it improves the functionality of a computer by estimating via the personalized cardiovascular hemodynamic model, cardiac parameters at different levels of physical activity, which is performed in real time (Applicant’s Remarks, Pg. 22-23). Applicant’s arguments are not persuasive for the following reasons:
The limitations of “estimating, via the personalized cardiovascular hemodynamic model, the cardiac parameters including cardiac output, ejection fraction, and mean arterial pressure, using the estimated plurality of input parameters” and “wherein the SVR across the section is modulated based on the MET levels, depending on the activity being performed by the subject” have been identified as reciting judicial exceptions in Step 2A, Prong One above. Similar to the arguments directly above, the integration of judicial exceptions into practical applications can only be achieved by additional elements, not by limitations that recite judicial exceptions. Additionally, similar to the arguments directly above, there is no indication that the functioning of the computer has been improved, and thus the limitations merely invoke the computer as a tool. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it integrates the judicial exception for a prophylaxis for a disease or medical condition by emulating underlying cardiac pathology in a personalized cardiovascular hemodynamic model for the subject being monitored. As part of a post-operative monitoring process, during therapy planning, a care giver simulates different heart rate conditions along with post-operative valvular conditions and selects different exercise levels, linked with MET value (Applicant’s Remarks, Pg. 23). Applicant’s arguments are not persuasive for the following reasons:
MPEP 2106.05(a) recites:
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., thereby increasing the bandwidth of the channel"). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim "as a whole," in other words, the claim should be evaluated "as an ordered combination, without ignoring the requirements of the individual steps." When performing this evaluation, examiners should be "careful to avoid oversimplifying the claims" by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
The alleged improvements indicated by Applicant are not commensurate in scope with the claimed invention. Applicant appears to assert that the claimed features may be used for therapy planning, or as part of the post-operative monitoring process (specification, para. [0090]). However, the claim only estimates the output cardiac parameters and does not provide any indication of using the cardiac parameters estimated from the personalized model for therapy planning or post-operative monitoring. Therefore, it appears the alleged improvements are not commensurate in scope with the claimed invention. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it improves the functionality of a computer by simulating cardiac output that provides a baseline activity response based on which the caregiver may plan daily ambulatory activities and therapy (Applicant’s Remarks, Pg. 24). Applicant’s arguments are not persuasive for the following reasons:
Similar to the arguments recited above, the limitation of “estimating, via the personalized cardiovascular hemodynamic model, the cardiac parameters including cardiac output, ejection fraction, and mean arterial pressure, using the estimated plurality of input parameters” has been identified as reciting a judicial exception in Step 2A, Prong One above. Similar to the arguments directly above, the integration of a judicial exception into practical applications can only be achieved by additional elements, not by limitations that recite judicial exceptions. Additionally, similar to the arguments directly above, there is no indication that the functioning of the computer has been improved, and thus the limitations merely invoke the computer as a tool.
Furthermore, similar to the arguments recited above, the alleged improvements are not commensurate in scope with the claimed invention (see MPEP 2106.05(a)). Applicant appears to assert that the claimed features may be used to plan daily ambulatory activities and therapies (specification, para. [0090]). However, the claim only estimates the output cardiac parameters and does not provide any indication of using the cardiac parameters estimated from the personalized model for therapy planning. Therefore, it appears the alleged improvements are not commensurate in scope with the claimed invention. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it improves the functionality of a computer by activating cardiac chambers sequentially in a synchronized manner, by time-varying compliance functions (Applicant’s Remarks, Pg. 24). Applicant’s arguments are not persuasive for the following reasons:
The limitations reciting time-varying compliance functions in claims 3, 9, and 15 have been identified as reciting judicial exceptions in Step 2A, Prong One above. Similar to the arguments directly above, the integration of a judicial exception into practical applications can only be achieved by additional elements, not by limitations that recite judicial exceptions. Additionally, similar to the arguments directly above, there is no indication that the functioning of the computer has been improved, and thus the limitations merely invoke the computer as a tool. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it improves the functionality of a computer by estimating metabolic rate for a specific activity, by a metabolic equivalent of task. The MET is defined as the ratio of an exercise metabolic rate to a resting metabolic rate (Applicant’s Remarks, Pg. 25). Applicant’s arguments are not persuasive for the following reasons:
The limitations of “estimating the SVR using Metabolic EquivalenT (MET) levels associated with an activity level of the subject…” and “wherein the SVR across the section is modulated based on the MET levels, depending on the activity being performed by the subject” have been identified as reciting judicial exceptions in Step 2A, Prong One above. Similar to the arguments directly above, the integration of judicial exceptions into practical applications can only be achieved by additional elements, not by limitations that recite judicial exceptions. Additionally, similar to the arguments directly above, there is no indication that the functioning of the computer has been improved, and thus the limitations merely invoke the computer as a tool. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is similar to XY, LLC v. Trans Ova Genetics, 968 F.3d 1323, 1330-32 (Fed. Cir. 2020), which determined that claims to a method of operating flow cytometry apparatus to classify and sort particles into at least two populations in real time was not directed to an abstract idea of using a mathematical equation that permits rotating multidimensional data. The claimed subject matter includes the step of estimating the SVR using MET levels. Further, the claims provide post-operative monitoring, during therapy planning, and enable personalized cardiac rehabilitation guidance and care continuum using a personalized hemodynamic model that effectively simulates cardiac parameters when the patient performs an activity using a wearable device (Applicant’s Remarks, Pg. 25-26). Applicant’s arguments are not persuasive for the following reasons:
Similar to the arguments directly above, the alleged improvements indicated by Applicant are not commensurate in scope with the claimed invention. Applicant appears to assert that the claimed features may be used for therapy planning, as part of the post-operative monitoring process and care continuum (specification, para. [0090]). However, the claim only estimates the output cardiac parameters and does not provide any indication of using the cardiac parameters estimated from the personalized model for therapy planning, post-operative monitoring, or continuing care. Therefore, it appears the alleged improvements are not commensurate in scope with the claimed invention. This argument is thus not persuasive.
Applicant argues that the claimed subject matter is patent eligible because it improves the functionality of a computer by updating parameters associated with a personalized cardiovascular hemodynamic model (Applicant’s Remarks, Pg. 26-27). Applicant’s arguments are not persuasive for the following reasons:
The limitation of “updating an additional blood demand representing the unstressed blood volume during the activity using the generated sympathetic and parasympathetic nervous activities” has been identified as reciting a judicial exception in Step 2A, Prong One above. Similar to the arguments directly above, the integration of judicial exceptions into practical applications can only be achieved by additional elements, not by limitations that recite judicial exceptions. Additionally, similar to the arguments directly above, there is no indication that the functioning of the computer has been improved, and thus the limitations merely invoke the computer as a tool. This argument is thus not persuasive.
Applicant argues that the subject matter achieves significantly more in terms of emulating underlying cardiac pathology in a personalized cardiovascular hemodynamic model. As part of a post-operative monitoring process, during therapy planning, a care giver simulates different heart rate conditions along with post-operative valvular conditions and selects different exercise levels, linked with MET value (Applicant’s Remarks, Pg. 27). Applicant’s arguments are not persuasive for the following reasons:
Similar to the arguments above, the alleged improvements indicated by Applicant are not commensurate in scope with the claimed invention. Applicant appears to assert that the claimed features may be used for therapy planning, as part of the post-operative monitoring process by simulating different heart rate conditions at different exercise/MET levels (specification, para. [0090]). However, the claim only estimates the output cardiac parameters and does not provide any indication of using the cardiac parameters estimated from the personalized model for therapy planning or post-operative monitoring. Therefore, it appears the alleged improvements are not commensurate in scope with the claimed invention. This argument is thus not persuasive.
Conclusion
No claims allowed.
Claims 1, 7, and 13 are free from the prior art because the prior art does not fairly teach or suggest the following limitations: wherein the step of estimating the SVR is represented as
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or wherein the SVR corresponds to a section of the body of the subject depending on the activity being performed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.P.S./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687