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 .
Claim Objections
Claim 1 is objected to because of the following informalities. Appropriate correction is required.
In re claim 1, the limitation “an assessment circuit configured to: to receive an indication of administered therapy;” should read “an assessment circuit configured to: receive an indication of administered therapy;”
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 limitations use 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 limitations are:
“a signal receiver circuit” (claim 1)
“an assessment circuit” (claim 1)
This application includes one or more claim limitations that use the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Such limitations are:
“means for receiving S3 heart sound information” (claim 3)
“means for receiving S1 heart sound information” (claim 5)
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 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 them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1
Independent claims 1 and 15 are directed to a medical device system and a method. Thus, the claims are directed statutory categories of invention (STEP 1: YES).
STEP 2a PRONG 1
Independent claims 1 and 15 recite the following limitations:
“determine a change in an HCM condition using the received S4 heart sound information by comparing S4 heart sound information by comparing S4 heart sound information over a first time period before the indication of administered HCM therapy with S4 heart sound information over a second time period subsequent to the indication of administered HCM therapy;” (mental process)
“determining, using the assessment circuit, an indication of patient condition based on the determined change in the HCM condition” (mental process)
Dependent claims recite the following limitations:
“wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound to indicate an improving patient condition” (further limiting the mental process of “determine a change”) (claim 2) (claim 17)
“compare the received S3 heart sound information over the first time period before the indication of administered HCM therapy with S3 heart sound information over the second time period subsequent to the indication of administered HCM therapy” (mental process) (claim 3) (claim 18)
“wherein to determine the change in HCM condition includes to detect an increasing S4 heart sound and a stable or decreasing S3 heart sound to indicate an improving patient condition” (further limiting the mental process of “determine a change”) (claim 4)
“compare the received S1 heart sound information over the first time period before the indication of administered HCM therapy with S1 heart sound information over the second time period subsequent to the indication of administered HCM therapy” (mental process) (claim 5, 19)
“wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound and a stable or increasing S1 heart sound to indicate an improving patient condition” (further limiting the mental process of “determining a change”) (claim 6)
“wherein the assessment circuit is configured to adjust the exercise therapy based on the determined change in the HCM condition” (mental process) (claim 11)
“determine an indication of dehydration using the received impedance information and the received indication of administered HCM therapy” (mental process and further limiting the mental process of “determining an indication of dehydration”) (claim 14)
“provide a change in the sample rate based on the change in HCM condition” (mental process) (claim 15).
The above limitations are examples of mental processes. Under the broadest reasonable interpretation, mental processes are defined as concepts performed in the human mind (including observations, evaluations, judgements and opinions). See MPEP 2106.04(a)(2)(III). Examiner notes that the courts do not distinguish between a mental process performed in the human mind and a mental process that requires the use of a physical aid. The above limitations are nothing more than a doctor determining a change in a patient’s condition by comparing the patients heart sounds before and after administering a therapy.
For the reasons described above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea. (STEP 2a, PRONG 1: YES).
STEP 2a PRONG 2
Independent claims 1 and 15 recite the following additional elements:
“a signal receiver circuit” (generic computer component)
“an assessment circuit” (generic computer component)
“receive physiologic information of a patient, including S4 heart sound information” (insignificant extra solution activity)
“receive an indication of administered HCM therapy” (insignificant extra solution activity)
“provide an indication of HCM therapy efficacy to a user or process based on the determined change in HCM condition” (insignificant extra solution activity)
“providing, using the assessment circuit, the determined indication of patient condition to a user or process” ” (insignificant extra solution activity)
Dependent claims recite the following additional elements:
“means for receiving S3 heart sound information” (generic computer component) (claim 3)
“means for receiving S1 heart sound information” (generic computer component) (claim 5)
“indication of administered HCM therapy includes an indication of septal ablation therapy” (further limiting the additional element of “indication of administered HCM therapy”) (claim 7)
“indication of administered HCM therapy includes an indication of septal myectomy therapy” (further limiting the additional element, “indication of administered HCM therapy”) (claim 8)
“indication of administered HCM therapy includes an indication of pharmaceutical therapy” (further limiting the additional element of “indication of administered HCM therapy”) (claim 9, claim 20)
“indication of administered HCM therapy includes an indication of exercise therapy” (further limiting the additional element of “indication of administered HCM therapy”) (claim 10)
“provide the adjusted exercise therapy to the patient or a user or process” (insignificant extra solution activity) (claim 11)
“provide the adjusted exercise therapy to the patient or a user or process based on the determined change in the HCM condition and the indication of respiration” (insignificant extra solution activity) (claim 12)
“receive an indication of respiration” (insignificant extra solution activity) (claim 12)
“wherein the indication of respiration includes respiration rate (RR) or rapid shallow breathing index (RSBI)” (further limiting additional element of “receive an indication of respiration”) (claim 13)
“receive impedance information of the patient” (insignificant extra solution activity) (claim 14)
“provide the determined indication of dehydration to the patient or a user or a process” (insignificant extra solution activity) (claim 14)
“receiving S3 heart sound information” (insignificant extra solution activity) (claim 18)
“receiving S1 heart sound information” (insignificant extra solution activity) (claim 19)
The additional elements recited in the independent claims are examples of insignificant extra solution activity and generic computer components. Examiner notes that “provide an indication of HCM therapy efficacy” and “providing…the determined indication of patient condition” are merely instances of data output. Additionally, “receive an indication of administered HCM therapy” and “receive physiological information of a patients, including S4 heart sound information” are examples of data gathering. Lastly, “a signal receiver circuit” and “an assessment circuit” fail to provide significantly more because they amount to merely applying the abstract idea using generic computer components.
Similarly, the additional elements recited in the dependent claims fail to provide significantly more as they are examples of generic computer components, insignificant extra solution activity, or limitations that further limit existing additional elements (STEP 2a PRONG 2: NO).
Regarding the additional elements “provide the adjusted exercise therapy to the patient or a user or process” (claim 11) and “provide the adjusted exercise therapy to the patient or a user or a process” (claim 12). While providing “adjusted” therapy “to the patient” appears to potentially provide a practical application, the additional elements as a whole are considered insignificant extra solution activity given that there is a version of the invention where providing adjusted therapy to “the patient” is not required.
STEP 2B
The claims do not include any additional elements that amount to significantly more than the judicial exception.
As discussed above in Step 2A, Prong 2, the additional elements amount to no more than generic computer components and insignificant extra solution activity.
Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101 (STEP 2B: NO).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 9 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US 2015/0343223), in view of Zalevsky et al. (US 2019/0290145).
In re claim 1, Thakur discloses a medical device system (FIG. 1), comprising:
a signal receiver circuit ([0048]: “one or more physiological sensors integrated with the IMD 110”) configured to receive physiologic information ([0048]: “physiological signal”) of a patient, including S4 heart sound information ([0048]: “Examples of the physiological signal can include…one or more heart sounds”; [0071]: “S1, S2, S3 and S4 heart sounds”); and
an assessment circuit (113) configured to (FIG. 5; [0086]):
to receive an indication of administered therapy (504);
determine a change in a condition using the received S4 heart sound information (506) by comparing S4 heart sound information over a first time period before the indication of administered therapy (503, “A FIRST VALUE OF A HEMODYNAMIC STATUS PARAMETER”; [0090]: “…sensing one or more heart sounds”) with S4 heart sound information over a second time period subsequent to the indication of administered therapy (505, “A SECOND VALUE OF THE HEMODYNAMIC PARAMETER”);
provide an indication of therapy efficacy (506; [0095]: “selection of desired therapy”) to a user or *process (FIG. 5) based on the determined change in the condition.
*Examiner notes that under the broadest reasonable interpretation “providing an indication” to a “process” could be any form of communication, even communication between computer components. Therefore, the ability of Thakur to select “a desired therapy” is an example of providing an indication of therapy efficacy to a “process”.
Thakur does not disclose the condition being HCM and thus lacks an assessment circuit configured to:
to receive an indication of administered HCM therapy;
determine a change in an HCM condition using the received S4 heart sound information by comparing S4 heart sound information over a first time period before the indication of administered HCM therapy with S4 heart sound information over a second time period subsequent to the indication of administered HCM therapy;
provide an indication of HCM therapy efficacy to a user or process based on the determined change in HCM condition.
Zalevsky discloses an analogous medical device system (FIG. 6) that collects and analyzes a patient’s heart sound data [0077]. As disclosed by Zalevsky, a S4 heart sound typically appears immediately before a normal S1 heart sound. Additionally, presence of the S4 heart sound has been found to be indicative of a variety of conditions including hypertrophic cardiomyopathy (HCM) [0074].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the condition of Thakur to be hypertrophic cardiomyopathy, given that the presence of S4 heart sounds is also known to be indicative of hypertrophic cardiomyopathy, as taught by Zalevsky.
In re claim 2, the proposed combination yields (all mapping directed to Thakur), wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound to indicate an improving patient condition ([0090]; [0094]: “…desired therapy can be selected as the hemodynamic status parameter that yields higher value of the hemodynamic parameter”).
In re claim 3, the proposed combination yields (all mapping directed to Thakur),
wherein the signal receiver circuit further includes means for receiving S3 heart sound information ([0076]: “HS component detector can further detect…one or more HS components including S1, S2, S3 and S4 heart sounds.”); and
wherein the assessment information is further configured to compare the received S3 heart sound information of a first time period before the indication of administered HCM therapy with S3 heart sound information over the second time period subsequent to the indication of administered HCM therapy (FIG. 5; [0078]: hemodynamic parameters used during comparison are generated “using the HS components such as one or more of S1, S2, S3 or S4 heart sounds”).
In re claim 4, the proposed combination yields (all mapping directed to Thakur),
wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound to indicate an improving patient condition ([0090]; [0094]: “…desired therapy can be selected as the hemodynamic status parameter that yields higher value of the hemodynamic parameter”).
The proposed combination does not yield,
wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound and a stable or decreasing s3 heart sound to indicate an improving patient condition.
Zalevsky further discusses a clinical significance of an S3 heart sound [0073]. As disclosed by Zalevsky, the S3 heart sound appears at the end of a cardiac cycle and is often indicative of ventricular dysfunction [0073].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to determine the change in the HCM condition by also detecting a stable or decreasing S3 heart sound given the presence of an S3 heart sound is known to be indicative of ventricular dysfunction as evidenced by Zalevsky (Zalevsky, [0073]).
In re claim 5, the proposed combination yields (all mapping directed to Thakur),
wherein the signal receiver circuit further includes means for receiving S1 heart sound information ([0076]: “HS component detector can further detect…one or more HS components including S1, S2, S3 and S4 heart sounds.”); and
wherein the assessment circuit is further configured to compare the received S1 heart sound information over the first time period before the indication of administered HCM therapy with S1 heart sound information over the second time period subsequent to the indication of administered HCM therapy (FIG. 5; [0078]: hemodynamic parameters used during comparison are generated “using the HS components such as one or more of S1, S2, S3 or S4 heart sounds”).
In re claim 6, the proposed combination yields (all mapping directed to Thakur),
wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound to indicate an improving patient condition ([0090]; [0094]: “…desired therapy can be selected as the hemodynamic status parameter that yields higher value of the hemodynamic parameter”).
The proposed combination does not yield,
wherein to determine the change in the HCM condition includes to detect an increasing S4 heart sound and a stable or increasing S1 heart sound to indicate an improving patient condition.
Zalevsky further discloses a clinical significance of an S1 heart sound [0070]. As disclosed by Zalevsky, intensity of the S1 sound directly relates to ventricular contraction force [0070]. Lower S1 intensities are commonly associate with decreased heart contractility [0070].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to determine the change in the HCM condition by also detecting a stable or increasing S1 heart sound given that lower S1 intensities are commonly associated with decreased heart contractility, as taught by Zalevsky (Zalevsky, [0073]).
In re claim 9, the proposed combination yields (all mapping directed to Thakur), wherein the indication of administered HCM therapy includes an indication of a pharmaceutical therapy (FIG. 2: 225, “PHARMACOLOGICAL THERAPY CIRCUIT”; [0060]).
In re claim 16, see above (In re claim 1).
The proposed combination also yields: a method (Thakur, Fig. 5; [0086]).
In re claim 17, see above (In re claim 2).
In re claim 18, see above (In re claim 3).
In re claim 19, see above (In re claim 4).
In re claim 20, see above (In re claim 9).
Claims 7, 8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US 2015/0343223), in view of Zalevsky et al. (US 2019/0290145), in view of Bayonas-Ruiz et al. ( Adrián Bayonas-Ruiz et al., Current Therapies for Hypertrophic Cardiomyopathy: A Systematic Review and Meta-Analysis of the Literature, ESC Heart Failure, Volume 10, Issue 1, February 2023, Pages 8–23).
In re claim 7, the proposed combination yields (all mapping directed to Thakur),
wherein the indication of administered HCM therapy includes an indication of ablation therapy (FIG. 2: 223, “CARDIAC ABLATION THERAPY CIRCUIT”; [0060]).
The proposed combination does not yield, the administered HCM therapy including septal ablation therapy.
Bayonas-Ruiz provides a summary of current therapies used to treat HCM. As disclosed by Bayonas-Ruiz, current therapies used to treat HCM include pharmacological agents, septal myectomy, septal ablation, right ventricular pacing, and physical conditioning (pg. 8, “Introduction”, [1]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ablation therapy of the proposed combination to be septal ablation therapy, as taught by Bayonas-Ruiz. One would have been motivated to make this modification because septal ablation therapy is a known treatment for patients with HCM (Bayonas-Ruiz: pg. 8, “Introduction”, [1]). Moreover, one of ordinary skill in the art would have the ability to choose the type of ablation therapy that would best meet their needs. Accordingly, such a modification would yield “wherein the indication of administered HCM therapy includes an indication of septal ablation therapy”.
In re claim 8, the proposed combination does not yield, wherein the indication of administered HCM therapy includes an indication of septal myectomy therapy.
As discussed in paragraph 61 , Bayonas-Ruiz discloses a variety of therapies used to treat HCM one of which is septal myectomy (pg. 8, “Introduction”, [1]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the administered HCM therapy of the proposed combination to be septal myectomy therapy, as taught by Bayonas-Ruiz. One would have been motivated to make this modification because septal myectomy therapy is a known treatment for patients with HCM (Bayonas-Ruiz: pg. 8, “Introduction”, [1]). Moreover, one of ordinary skill in the art would have the ability to choose the type of administered HCM therapy that would best meet their needs. Accordingly, such a modification would yield “wherein the indication of administered HCM therapy includes an indication of septal myectomy therapy”.
In re claim 10, the proposed combination does not yield, wherein the indication of administered HCM therapy includes an indication of exercise therapy.
As discussed in paragraph 61, Bayonas-Ruiz discloses a variety of therapies used to treat HCM one of which is physical conditioning (pg. 8, “Introduction”, [1]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the administered HCM therapy of the proposed combination to be exercise therapy, as taught by Bayonas-Ruiz. One would have been motivated to make this modification because exercise therapy is a known treatment for patients with HCM (Bayonas-Ruiz: pg. 8, “Introduction”, [1]). Moreover, one of ordinary skill in the art would have the ability to choose the type of administered HCM therapy that would best meet their needs. Accordingly, such a modification would yield “wherein the indication of administered HCM therapy includes an indication of exercise therapy”.
In re claim 11, the proposed combination yields (all mapping directed to Thakur unless indicated otherwise), wherein the assessment circuit is configured
to *adjust exercise therapy based on the determined change in the HCM condition (506, “determining a desirable therapy”; additionally see modification above (In re claim 10) that yields “administered HCM therapy” being “exercise therapy”) and
to provide the adjusted therapy to the patient or a user [0051; 0072] or a process (FIG. 5).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US 2015/0343223), in view of Zalevsky et al. (US 2019/0290145), in view of Bayonas-Ruiz et al. ( Adrián Bayonas-Ruiz et al., Current Therapies for Hypertrophic Cardiomyopathy: A Systematic Review and Meta-Analysis of the Literature, ESC Heart Failure, Volume 10, Issue 1, February 2023, Pages 8–23), in view of Min et al. (US 2020/0046312).
In re claim 12, the proposed combination yields, wherein the assessment circuit is configured
to provide the adjusted exercise therapy to the patient or a user or process based on the determined change in the HCM condition (see above In re claim 11).
The proposed combination does not yield, the assessment circuit being configured
to receive an indication of respiration and
to provide the adjusted exercise therapy to the patient or a user or process based on the determined change in the HCM condition and the indication of respiration.
Min discloses an analogous medical system (FIG. 2) that monitors a patient’s cardiac function by measuring heart sounds (abstract). In addition to measuring heart sounds the medical system measures other physiological information of the patient like respiration rate, position/posture, blood PH, and activity [0044]. As disclosed by Min, this additional measured physiological information is used to adjust therapy according to an exercise state of the patient [0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to receive an indication of respiration, as taught by Min. One would have been motivated to make this modification to account for changes in heart activity that may be unrelated to the patients changing HCM condition.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the adjusted therapy based on the determined change in the HCM condition and the indication of respiration, as taught by Min. One would have been motivated to make this modification because it is known to adjust therapy according to the patient’s exercise state (Min, [0044]).
In re claim 13, the proposed combination does not yield, wherein the indication of respiration includes respiration rate (RR) or rapid shallow breathing index (RSBI).
As discussed in paragraph 74, Min discloses adjusting therapy according to the patients exercise state [0044] which is determined in part by measuring the patient’s respiration rate [0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the indication of respiration of the proposed combination to include respiration rate (RR), as taught by Min. One would have been motivated to make this modification because respiration rate is a known parameter used to detect changes in a patient’s exercise state, as evidenced by Min (Min, [0044]).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US 2015/0343223), in view of Zalevsky et al. (US 2019/02901457), in view of Thakur et al. (US 2021/0204874; herein referred to as Thakur II).
In re claim 14, the proposed combination yields (all mapping directed to Thakur),
wherein the signal receiver circuit is configured to receive impedance information of the patient ([0061]: “Examples of the hemodynamic sensor and the physiological variables to sense can include…impedance sensors”) ,
The proposed combination does not yield:
wherein the assessment circuit is configured
to determine an indication of dehydration of the patient using the received impedance information and the received indication of administered HCM therapy and
to provide the determined indication of dehydration to the patient or a user or process.
Thakur II discloses a medical system (FIG. 10), that like the proposed combination, is capable of receiving and analyzing physiological information of a patient (abstract; FIG. 11: 1101). Examples of physiological information received and analyzed by the medical system include impedance information and heart sound information [0104]. As disclosed by Thakur II, impedance information is used in part to determine an indication of dehydration of the patient (1102; [0105, 0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to determine an indication of dehydration of the patient using the received impedance information, as taught by Thakur II. One would have been motivated to make this modification both because calculating an indication of dehydration using impedance information is known in the art (Thakur, [0105, 0106]) and because dehydration effects heart sound intensity (Thakur II, [0068]).
Thakur II further discloses having the ability to output information, like a determined indication, to a user via a display or alternative user interface [0081].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to provide the determined indication of dehydration to a user, as taught by Thakur II. One would have been motivated to make this modification because doing so would enable the user to immediately take steps to counteract the negative effects of dehydration (Thakur II, [0042]).
Regarding the limitation “and the received indication of administered HCM therapy”, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine an indication of dehydration using the impedance information and the received indication of administered HCM therapy, given that a delivered therapy would affect tissue impedance and thus effect the medical systems determination of dehydration.
In re claim 15, the proposed combination does not yield, wherein the assessment circuit is configured to provide a change in sample rate based on the change in the HCM condition.
Thakur II further discloses implementing a high-powered monitoring method in response to detecting a worsening patient condition [0061]. As disclosed by Thakur II, the high-powered monitoring method includes additional sensors, a higher sampling rate, and additional data processing [0061].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to provide a change in sample rate based on the change in a condition, as taught by Thakur II. One would have been motivated to make this modification because doing so would ensure that patients with worsening conditions can be more closely/frequently monitored (Thakur II; [0061]). Accordingly, such a modification would yield “wherein the assessment circuit is configured to provide a change in the sample rate based on the change in the HCM condition”.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mai et al. (US 6,643,584) discloses an implantable cardiac device (FIG. 1: 10) that detects heart disease by monitoring a patient’s heart sounds (abstract). As disclosed by Mai, the implantable cardiac device is capable of delivering stimulation therapy and adjusting said stimulation therapy in response to changes in the patient’s heart sounds (col. 2, lines 56-64 ; col. 11, lines 1-12)
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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