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 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: “mechanical circulatory support device” in claims 1 and 19.
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 § 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.
Claims 1-6, 8-15, 17-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 11357968 to El Katerji, and incorporated therein US 2018/0078159 by Edelman.
Regarding Claim 1, El Katerji teaches a method of determining a contractile reserve of a heart of a patient [According to Applicant, “contractile reserve metric” in the context of this application, is a “cardiac metric …that provides a numeric assessment of the ability of the ventricle to adapt to changing levels of workload”, see ¶ 66. While the units of this numeric assessment are not explicitly mentioned by Applicant, it is mentioned that “it may be determined by examining the variability of the cardiac contractility metric(s) across the different performance levels”, see ¶ 68. Wherein, “performance levels” are “pump speeds”, see ¶ 43, and “cardiac contractility metrics” are “estimates” that “can be related to” the slope of the pressure during contraction (dP/dt), “may be” a coefficient of cardiac contractility that represents the inherent strength and vigor of the heart’s contraction during systole, may correspond to values from look-up tables, “may be non-dimensional” and in one example is represented by stroke volume, see ¶ 47-49. Thus, under the broadest reasonable interpretation in light of Applicant’s specification, “cardiac contractility metric”: a) would include any metric indicative of “cardiac contractility”, a generic indicator of “strength and vigor”, and b) would include for example stroke volume. Thus, “contractile reserve” would include a change of this indicative metric across two different pump speed levels. El Katerji discloses determining a “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”, see 9:1-3, and “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”, see 3:45-56, wherein the “hemodynamic parameter” includes “cardiac contractility”, “stroke volume”, “stroke volume index”, stroke volume variation”, “left ventricular stroke work”, “left ventricular stroke work index”, “ejection fraction”, “cardiac power output”, etc., all of which are indicative of cardiac contractility, see 5:6-48, 9:1-40 and 23:55-62, and the two phases include a controlled change in pump speed in order to perform a controlled perturbation, see abstract and 9:1-40 (emphasis added). Thus, El Katerji discloses determining a change in a cardiac contractility metric across different motor speeds, which anticipates determining a “contractile reserve”, as further discussed below], the heart having a mechanical circulatory support device arranged therein, the method comprising:
controlling the mechanical circulatory support device to operate at a first performance level (e.g. abstract, 2:36-57, 19:44—20:11: operating the pump at a “normal” operation speed; Also see 17:46-65, 18:5-20);
determining based, at least in part, on a motor current signal received from a motor when the mechanical circulatory support device is operating at the first performance level, at least one first value for a cardiac contractility metric (e.g. 19: 44—20:11, 20:31—21:4: motor current is used to determine the hemodynamic parameters, including contractility, stroke volume, ejection fraction, cardiac power output etc., all indicators of cardiac contractility; It is also noted that the comparisons may be synchronized to begin at the onset of systole and be taken during systole, something which is also evidence of contractility measurements. Also see 5:6-48, 9:1-40 and 23:55-62 and the parameter “ip” in equations 1, 4-6, including the two different speed measurements of equations 5-6);
controlling the mechanical circulatory support device to operate at a second performance level (e.g. abstract, 2:36-57: increasing the speed of the pump from the normal operating speed);
determining based, at least in part, on the motor current signal received from the motor when the mechanical circulatory support device is operating at the second performance level, at least one second value for the cardiac contractility metric (e.g. 19: 44—20:11, 20:31—21:4: motor current is used to determine the hemodynamic parameters, including contractility, stroke volume, ejection fraction, cardiac power output etc., all indicators of cardiac contractility; Also see 5:6-48, 9:1-40 and 23:55-62 and the parameter “ip” in equations 1, 4-6, including the two different speed measurements of equations 5-6);
determining a contractile reserve metric based, at least in part, on the at least one first value and the at least one second value of the cardiac contractility metric [According to Applicant, “contractile reserve metric” in the context of this application, is a “cardiac metric …that provides a numeric assessment of the ability of the ventricle to adapt to changing levels of workload”, see ¶ 66. While the units of this numeric assessment are not explicitly mentioned by Applicant, it is mentioned that “it may be determined by examining the variability of the cardiac contractility metric(s) across the different performance levels”, see ¶ 68. Wherein, “performance levels” are “pump speeds”, see ¶ 43, and “cardiac contractility metrics” are “estimates” that “can be related to” the slope of the pressure during contraction (dP/dt), “may be” a coefficient of cardiac contractility that represents the inherent strength and vigor of the heart’s contraction during systole, may correspond to values from look-up tables, “may be non-dimensional” and in one example is represented by stroke volume, see ¶ 47-49. Thus, under the broadest reasonable interpretation in light of Applicant’s specification, “cardiac contractility metric”: a) would include any metric indicative of “cardiac contractility”, a generic indicator of “strength and vigor”, and b) would include for example stroke volume. Thus, “contractile reserve” would include a change of this indicative metric across two different pump speed levels. El Katerji discloses determining a “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”, see 9:1-3, and “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”, see 3:45-56, wherein the “hemodynamic parameter” includes “cardiac contractility”, “stroke volume”, “stroke volume index”, stroke volume variation”, “left ventricular stroke work”, “left ventricular stroke work index”, “ejection fraction”, “cardiac power output”, “heart recovery”, etc., all of which are indicative of cardiac contractility, see 5:6-48, 9:1-40 and 23:55-62, and the two phases include a controlled change in pump speed in order to perform a controlled perturbation, see abstract and 9:1-40 (emphasis added). Thus, El Katerji discloses determining a change in a cardiac contractility metric across different motor speeds, which anticipates determining a “contractile reserve”; Also see 19:32—21:4, 21:65—38, 23:55—24:36].
El Katerji does not explicitly disclose outputting an indication of the contractile reserve metric on a user interface associated with the mechanical circulatory support device.
However, El Katerji teaches displaying measurements on a display of the control system (19:38-43). Furthermore, El Katerji via Edelman, which is incorporated by reference in El Katerji (18:22-26), teaches displaying hemodynamic parameters, including contractility indicators and changes thereof (¶¶ 162,168, Fig. 20A-20B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate outputting an indication of the contractile reserve metric on a user interface associated with the mechanical circulatory support device in a method according to the teachings of El Katerji, as taught by El Katerji and incorporated therein Edelman, in order to: a) predictably display the indication of the metric, b) inform a clinician as it relates to the health status of the patient, the progress of the health condition and treatment, c) permit the clinician to make informed decisions as it relates to titration and weaning off the treatment, as suggested by Edelman (¶5,113) and El Katerji (17:27—18:5).
Regarding Claim 2, El Katerji as modified in Claim 1 teaches the method of claim 1, wherein the mechanical circulatory support device is configured to operate at a predetermined number of performance levels including the first performance level and the second performance level, and wherein the method further comprises: controlling the mechanical circulatory support device to operate at each of the predetermined number of performance levels; and determining based, at least in part, on the motor current signal received from the motor when the mechanical circulatory support device is operating at each of the predetermined number of performance levels, a corresponding at least one value for the cardiac contractility metric, wherein the contractile reserve metric is determined based, at least in part, on the at least one value determined when the mechanical circulatory support device was operating at each of the predetermined number of performance levels (e.g. 2:36-57, 5:49-65: multiple speeds are used to determine the changes to the hemodynamic parameter, which includes contractility indicators; As a side note, the claim does not require more than two speed levels in order to be met as currently drawn).
Regarding Claim 3, El Katerji as modified in Claim 1 teaches the method of claim 1, further comprising: receiving, from a pressure sensor associated with the mechanical circulatory support device, a pressure signal, wherein the at least one first value for the cardiac contractility metric is determined based, at least in part, on the pressure signal when the mechanical circulatory support device was operating at the first performance level, and the at least one second value for the cardiac contractility metric is determined based, at least in part, on the pressure signal when the mechanical circulatory support device was operating at the second performance level (e.g. 20:31-67: pressure head sensing is used along with motor current measurement in order to determine the hemodynamic parameters, which include indicators of contractility).
Regarding Claim 4, El Katerji as modified in Claim 1 teaches the method of claim 1, wherein the at least one first value for the cardiac contractility metric and/or the at least one second value for the cardiac contractility metric is determined based, at least in part, on data stored in data storage associated with the mechanical circulatory support device (e.g. 20:55-65, 30:5-22: stored values in look-up tables; Also, note here that all processors rely on cache memory to operate).
Regarding Claim 5, El Katerji as modified in Claim 1 teaches the method of claim 1, wherein determining a contractile reserve metric based, at least in part, on the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric comprises analyzing a variance between the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric [e.g. 9:1-3: “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”; 3:45-56: “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”]
Regarding Claim 6, El Katerji as modified in Claim 1 teaches the method of claim 1, wherein the cardiac contractility metric includes a contractility index and/or a contractility score (Any numerical value reads on “index” or “score”, and as discussed in Claim 1, contractility is measured by a variety of “hemodynamic parameters” represented by numerical values, including “cardiac contractility”, “stroke volume”, “stroke volume index”, stroke volume variation”, “left ventricular stroke work”, “left ventricular stroke work index”, “ejection fraction”, “cardiac power output”, “heart recovery”, etc., all of which are indicative of cardiac contractility, see 5:6-48, 9:1-40 and 23:55-62; Contractility indices are also taught via Edelman, see Fig. 20B: contractility score 2010).
Regarding Claim 8, El Katerji as modified in Claim 1 teaches the method of claim 1, wherein outputting an indication of the contractile reserve metric comprises displaying on the user interface, a graph of the at least one value for the cardiac contractility metric determined at each of the first and second performance levels (e.g. as modified in Claim 1, according to the teachings of Edelman, see Fig. 20A: graph of changes to contractility 2008).
Regarding Claim 9, El Katerji as modified in Claim 1 teaches the method of claim 1, wherein outputting an indication of the contractile reserve metric comprises displaying on the user interface, a numerical value for the contractile reserve metric (as modified in Claim 1, according to the teachings of El Katarji and Edelman, the value of the metric would be displayed, see e.g. Fig. 20B of Edelman: similar to contractility score 2010, state score 2012 or the tracking of contractility changes via a numerical graph such as 2008/2010 of Fig. 20A).
Regarding Claim 10, El Katerji teaches a mechanical circulatory support device (e.g. 4:13-16: blood pump), comprising:
a rotor (e.g. 4:4-10: rotor);
a motor configured to drive rotation of the rotor at a plurality of speeds (e.g. 4:4-10; 5:49-65: motor with multiple speeds); and
at least one controller (e.g. 3:65—4:16: controller/control system) configured to:
control the motor to operate at a first speed (e.g. abstract, 2:36-57, 19:44—20:11: operating the pump at a “normal” operation speed; Also see 17:46-65, 18:5-20);
determine based, at least in part, on a motor current signal received from the motor when operating at the first speed, at least one first value for a cardiac contractility metric (e.g. 19: 44—20:11, 20:31—21:4: motor current is used to determine the hemodynamic parameters, including contractility, stroke volume, ejection fraction, cardiac power output etc., all indicators of cardiac contractility; Also see 5:6-48, 9:1-40 and 23:55-62 and the parameter “ip” in equations 1, 4-6, including the two different speed measurements of equations 5-6);
control the motor to operate at a second speed (e.g. abstract, 2:36-57: increasing the speed of the pump from the normal operating speed);
determine based, at least in part, on a motor current signal received from the motor when operating at the second speed, at least one second value for the cardiac contractility metric (e.g. 19: 44—20:11, 20:31—21:4: motor current is used to determine the hemodynamic parameters, including contractility, stroke volume, ejection fraction, cardiac power output etc., all indicators of cardiac contractility; Also see 5:6-48, 9:1-40 and 23:55-62 and the parameter “ip” in equations 1, 4-6, including the two different speed measurements of equations 5-6);
determine a contractile reserve metric based, at least in part, on the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric [According to Applicant, “contractile reserve metric” in the context of this application, is a “cardiac metric …that provides a numeric assessment of the ability of the ventricle to adapt to changing levels of workload”, see ¶ 66. While the units of this numeric assessment are not explicitly mentioned by Applicant, it is mentioned that “it may be determined by examining the variability of the cardiac contractility metric(s) across the different performance levels”, see ¶ 68. Wherein, “performance levels” are “pump speeds”, see ¶ 43, and “cardiac contractility metrics” are “estimates” that “can be related to” the slope of the pressure during contraction (dP/dt), “may be” a coefficient of cardiac contractility that represents the inherent strength and vigor of the heart’s contraction during systole, may correspond to values from look-up tables, “may be non-dimensional” and in one example is represented by stroke volume, see ¶ 47-49. Thus, under the broadest reasonable interpretation in light of Applicant’s specification, “cardiac contractility metric”: a) would include any metric indicative of “cardiac contractility”, a generic indicator of “strength and vigor”, and b) would include for example stroke volume. Thus, “contractile reserve” would include a change of this indicative metric across two different pump speed levels. El Katerji discloses determining a “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”, see 9:1-3, and “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”, see 3:45-56, wherein the “hemodynamic parameter” includes “cardiac contractility”, “stroke volume”, “stroke volume index”, stroke volume variation”, “left ventricular stroke work”, “left ventricular stroke work index”, “ejection fraction”, “cardiac power output”, “heart recovery”, etc., all of which are indicative of cardiac contractility, see 5:6-48, 9:1-40 and 23:55-62, and the two phases include a controlled change in pump speed in order to perform a controlled perturbation, see abstract and 9:1-40 (emphasis added). Thus, El Katerji discloses determining a change in a cardiac contractility metric across different motor speeds, which anticipates determining a “contractile reserve”; Also see 19:32—21:4, 21:65—38, 23:55—24:36].
El Katerji does not explicitly disclose that the controller is configured to output an indication of the contractile reserve metric on a user interface associated with the mechanical circulatory support device.
However, El Katerji teaches displaying measurements on a display of the control system (19:38-43). Furthermore, El Katerji via Edelman, which is incorporated by reference in El Katerji (18:22-26), teaches displaying hemodynamic parameters, including contractility indicators and changes thereof (¶¶ 162,168, Fig. 20A-20B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate outputting an indication of the contractile reserve metric on a user interface associated with the mechanical circulatory support device in a controller according to the teachings of El Katerji, as taught by El Katerji and incorporated therein Edelman, in order to: a) predictably display the indication of the metric, b) inform a clinician as it relates to the health status of the patient, the progress of the health condition and treatment, c) permit the clinician to make informed decisions as it relates to titration and weaning off the treatment, as suggested by Edelman (¶5,113) and El Katerji (17:27—18:5).
Regarding Claim 11, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, wherein the at least one controller is further configured to: control the motor to operate at a predetermined number of speeds including the first speed and the second speed; and determine based, at least in part, on the motor current signal received from the motor when the motor is operating at each of the predetermined number of speeds, a corresponding at least one value for the cardiac contractility metric, wherein the contractile reserve metric is determined based, at least in part, on the at least one value determined when the motor was operating at each of the predetermined number of speeds (e.g. 2:36-57, 5:49-65: multiple speeds are used to determine the changes to the hemodynamic parameter, which includes contractility indicators).
Regarding Claim 12, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, further comprising: a pressure sensor configured to measure a pressure signal, wherein the at least one first value for the cardiac contractility metric is determined based, at least in part, on the pressure signal when the motor was operating at the first speed, and the at least one second value for the cardiac contractility metric is determined based, at least in part, on the pressure signal when the motor was operating at the second speed (e.g. 20:31-67: pressure head sensing is used along with motor current measurement in order to determine the hemodynamic parameters, which include indicators of contractility).
Regarding Claim 13, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, further comprising data storage, wherein the at least one first value for the cardiac contractility metric and/or the at least one second value for the cardiac contractility metric is determined based, at least in part, on data stored in the data storage (e.g. 20:55-65, 30:5-22: stored values in look-up tables; Also, note here that all processors rely on cache memory to operate).
Regarding Claim 14, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, wherein determining a contractile reserve metric based, at least in part, on the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric comprises analyzing a variance between the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric [e.g. 9:1-3: “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”; 3:45-56: “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”].
Regarding Claim 15, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, wherein the cardiac contractility metric includes a contractility index and/or a contractility score (Any numerical value reads on “index” or “score”, and as discussed in Claim 1, contractility is measured by a variety of “hemodynamic parameters” represented by numerical values, including “cardiac contractility”, “stroke volume”, “stroke volume index”, stroke volume variation”, “left ventricular stroke work”, “left ventricular stroke work index”, “ejection fraction”, “cardiac power output”, “heart recovery”, etc., all of which are indicative of cardiac contractility, see 5:6-48, 9:1-40 and 23:55-62; Contractility indices are also taught via Edelman, see Fig. 20B: contractility score 2010).
Regarding Claim 17, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, wherein outputting an indication of the contractile reserve metric comprises displaying on the user interface, a graph of the at least one value for the cardiac contractility metric determined at each of the first and second speeds (e.g. as modified in Claim 1, according to the teachings of Edelman, see Fig. 20A: graph of changes to contractility 2008).
Regarding Claim 18, El Katerji as modified in Claim 10 teaches the mechanical circulatory support device of claim 10, wherein outputting an indication of the contractile reserve metric comprises displaying on the user interface, a numerical value for the contractile reserve metric (as modified in Claim 1, according to the teachings of El Katarji and Edelman, the value of the metric would be displayed, see e.g. Fig. 20B of Edelman: similar to contractility score 2010, state score 2012 or the tracking of contractility changes via a numerical graph such as 2008/2010 of Fig. 20A).
Regarding Claim 19, El Katerji discloses a controller for a mechanical circulatory support device, the controller (e.g. 3:65—4:16: controller/control system) comprising:
at least one hardware processor (e.g. 34:20-58: processor) configured to:
control the motor to operate at a first speed (e.g. abstract, 2:36-57, 19:44—20:11: operating the pump at a “normal” operation speed; Also see 17:46-65, 18:5-20);
determine based, at least in part, on a motor current signal received from the motor when operating at the first speed, at least one first value for a cardiac contractility metric (e.g. 19: 44—20:11, 20:31—21:4: motor current is used to determine the hemodynamic parameters, including contractility, stroke volume, ejection fraction, cardiac power output etc., all indicators of cardiac contractility; Also see 5:6-48, 9:1-40 and 23:55-62 and the parameter “ip” in equations 1, 4-6, including the two different speed measurements of equations 5-6);
control the motor to operate at a second speed (e.g. abstract, 2:36-57: increasing the speed of the pump from the normal operating speed);
determine based, at least in part, on a motor current signal received from the motor when operating at the second speed, at least one second value for the cardiac contractility metric (e.g. 19: 44—20:11, 20:31—21:4: motor current is used to determine the hemodynamic parameters, including contractility, stroke volume, ejection fraction, cardiac power output etc., all indicators of cardiac contractility; Also see 5:6-48, 9:1-40 and 23:55-62 and the parameter “ip” in equations 1, 4-6, including the two different speed measurements of equations 5-6);
determine a contractile reserve metric based, at least in part, on the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric [According to Applicant, “contractile reserve metric” in the context of this application, is a “cardiac metric …that provides a numeric assessment of the ability of the ventricle to adapt to changing levels of workload”, see ¶ 66. While the units of this numeric assessment are not explicitly mentioned by Applicant, it is mentioned that “it may be determined by examining the variability of the cardiac contractility metric(s) across the different performance levels”, see ¶ 68. Wherein, “performance levels” are “pump speeds”, see ¶ 43, and “cardiac contractility metrics” are “estimates” that “can be related to” the slope of the pressure during contraction (dP/dt), “may be” a coefficient of cardiac contractility that represents the inherent strength and vigor of the heart’s contraction during systole, may correspond to values from look-up tables, “may be non-dimensional” and in one example is represented by stroke volume, see ¶ 47-49. Thus, under the broadest reasonable interpretation in light of Applicant’s specification, “cardiac contractility metric”: a) would include any metric indicative of “cardiac contractility”, a generic indicator of “strength and vigor”, and b) would include for example stroke volume. Thus, “contractile reserve” would include a change of this indicative metric across two different pump speed levels. El Katerji discloses determining a “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”, see 9:1-3, and “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”, see 3:45-56, wherein the “hemodynamic parameter” includes “cardiac contractility”, “stroke volume”, “stroke volume index”, stroke volume variation”, “left ventricular stroke work”, “left ventricular stroke work index”, “ejection fraction”, “cardiac power output”, “heart recovery”, etc., all of which are indicative of cardiac contractility, see 5:6-48, 9:1-40 and 23:55-62, and the two phases include a controlled change in pump speed in order to perform a controlled perturbation, see abstract and 9:1-40 (emphasis added). Thus, El Katerji discloses determining a change in a cardiac contractility metric across different motor speeds, which anticipates determining a “contractile reserve”; Also see 19:32—21:4, 21:65—38, 23:55—24:36].
El Katerji does not explicitly disclose that the controller is configured to output an indication of the contractile reserve metric on a user interface associated with the mechanical circulatory support device.
However, El Katerji teaches displaying measurements on a display of the control system (19:38-43). Furthermore, El Katerji via Edelman, which is incorporated by reference in El Katerji (18:22-26), teaches displaying hemodynamic parameters, including contractility indicators and changes thereof (¶¶ 162,168, Fig. 20A-20B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate outputting an indication of the contractile reserve metric on a user interface associated with the mechanical circulatory support device in a controller according to the teachings of El Katerji, as taught by El Katerji and incorporated therein Edelman, in order to: a) predictably display the indication of the metric, b) inform a clinician as it relates to the health status of the patient, the progress of the health condition and treatment, c) permit the clinician to make informed decisions as it relates to titration and weaning off the treatment, as suggested by Edelman (¶5,113) and El Katerji (17:27—18:5).
Regarding Claim 20, El Katerji as modified in Claim 19 teaches the controller of claim 19, wherein the at least one hardware processor is further configured to: control the motor to operate at a predetermined number of speeds including the first speed and the second speed; and determine based, at least in part, on the motor current signal received from the motor when the motor is operating at each of the predetermined number of speeds, a corresponding at least one value for the cardiac contractility metric, wherein the contractile reserve metric is determined based, at least in part, on the at least one value determined when the motor was operating at each of the predetermined number of speeds (e.g. 2:36-57, 5:49-65: multiple speeds are used to determine the changes to the hemodynamic parameter, which includes contractility indicators).
Regarding Claim 21, El Katerji as modified in Claim 19 teaches the controller of claim 19, wherein the at least one hardware processor is further configured to: receive, from a pressure sensor associated with the mechanical circulatory support device, a pressure signal, wherein the at least one first value for the cardiac contractility metric is determined based, at least in part, on the pressure signal when the motor was operating at the first speed, and the at least one second value for the cardiac contractility metric is determined based, at least in part, on the pressure signal when the motor was operating at the second speed (e.g. 20:31-67: pressure head sensing is used along with motor current measurement in order to determine the hemodynamic parameters, which include indicators of contractility).
Regarding Claim 23, El Katerji as modified in Claim 19 teaches the controller of claim 19, wherein determining a contractile reserve metric based, at least in part, on the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric comprises analyzing a variance between the at least one first value for the cardiac contractility metric and the at least one second value for the cardiac contractility metric [e.g. 9:1-3: “metric indicative of cardiac performance …based on the change in [a] hemodynamic parameter between the first phase and the second phase”; 3:45-56: “comparing the changes in one or more hemodynamic parameters during a “normal” or “reference” heartbeat (e.g., a heartbeat when the heart pump system is operating at a first pump speed) and during a “modulated” (e.g. a heartbeat when the heat pump system is operating at a different pump speed than the first pump speed for at least a portion of the heartbeat)”].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 1, 10 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18/628,505 in view of US 11357968 to El Katerji.
Regarding Claims 1, 10 and 19, Claim 17 of the copending application teaches a a method of: determining at least one first value for a cardiac contractility metric; determining at least one second value for the cardiac contractility metric; determining a contractile reserve metric based, at least in part, on the at least one first value and the at least one second value of the cardiac contractility metric (Claims 1,15-17).
Claim 17 of the copending application does not disclose that the two contractility metrics are based on two different motor speeds and determined via motor currents. However, El Katerji teaches an analogous method of monitoring cardiac hemodynamic parameters, including contractility metrics, by tracking changes to motor current of a blood pump operating at different speeds (as discussed in detail in the 103 rejection section above). It would have been obvious to a person having ordinary skill in the art to incorporate motor current derived contractility measurements at different operating speeds of a blood pump, as taught by El Katerji, in order to: a) predictably determine the contractility change indicators, and b) predictably track the state of the heart during treatment with a blood pump.
This is a provisional nonstatutory double patenting rejection.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796