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 Status: Claims 1-2, 5-6, 9, 13-15, 17, 19-24, 28, 36, 42, 44 and 46 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 5, 6, 9, 13-15, 17, and 19-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a method of providing sensory feedback to an operator of a mechanical circulatory support (MCS) device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 1 is directed towards a method.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “monitoring, using a controller of the MCS device, one or more physiological signals associated with a heart of a patient within which the MCS device is placed; generating an alert signal based, at least in part, on the monitored one or more physiological signals.”
The reason that the above limitation is considered an abstract idea is because it is directed to mental processes (observation, evaluation, judgment, opinion). The above step can be performed in the mind or by hand. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claims recite “a controller of the MCS device” which can be interpreted as a generic processor. The processing device and the programmable processor do not integrate the judicial exception into a practical application, because it is merely using a generic processor as a tool to perform an abstract idea (see MPEP 2106.05(f)).
The claim also recites “transmitting in response to generating the alert signal, a control signal from the controller of the MCS to a feedback device, wherein the feedback device is configured to provide sensory feedback to an operator of the MCS device based on the control signal.” Merely outputting sensory feedback using known, generic feedback device in response to an alert signal only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g).
The recitation is a use of generically recited computer element for its standard, well-known purpose, which does not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e).
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “a controller of the MCS device” and “transmitting in response to generating the alert signal, a control signal from the controller of the MCS to a feedback device, wherein the feedback device is configured to provide sensory feedback to an operator of the MCS device based on the control signal.”
The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, or as insignificant extra-solution activity to the judicial exception (See MPEP 2106.05(d)) and Berkheimer Memo.
Celentano (US 2010/0160860 A1) discloses a feedback device - a conventional liquid crystal display (para. [0043]), a conventional audible indication device 72, and a conventional vibratory device 74 (para. [0056], The UI processor 50 is generally operable to control the audible indication device 72 and the vibratory device 74 to produce one or more audible sounds and/or vibrations respectively to provide for the capability of the device 12 to produce corresponding audible and/or tactile notifications, i.e., alarms or the like) – to produce alarm notification.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 2, 5, 6, 9, 13-15, 17, and 19-23, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claims 24, 28, 36, 42, and 44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a mechanical circulatory support (MCS) device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 24 is directed towards a machine.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “monitor one or more physiological signals associated with the heart of the patient during operation of the pump; generate an alert signal based, at least in part, on the monitored one or more physiological signals”.
The reason that the above limitation is considered an abstract idea is because it is directed to mental processes (observation, evaluation, judgment, opinion). The above step can be performed in the mind or by hand. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claims recite “a controller” which can be interpreted as a generic processor. The processing device and the programmable processor do not integrate the judicial exception into a practical application, because it is merely using a generic processor as a tool to perform an abstract idea (see MPEP 2106.05(f)).
The claim also recites “a pump configured to be placed in a heart of a patient” generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and does not improve the functioning of any technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Additionally, it is an extra-solution activity in order to generate a physiological signal used for analysis in the abstract idea; see MPEP § 2106.05(g).
The claim also recites “a feedback device configured to provide sensory feedback to an operator of the MCS device” and “transmit in response to generating the alert signal, a control signal from the controller of the MCS to the feedback device, wherein the feedback device is configured to provide the sensory feedback based on the control signal.” Merely outputting sensory feedback using known, generic feedback device in response to an alert signal only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g).
The recitation is a use of generically recited computer element for its standard, well-known purpose, which does not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e).
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “a controller”, “a pump configured to be placed in a heart of a patient,” “a feedback device configured to provide sensory feedback to an operator of the MCS device,” and “transmit in response to generating the alert signal, a control signal from the controller of the MCS to the feedback device, wherein the feedback device is configured to provide the sensory feedback based on the control signal.”
The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, or as insignificant extra-solution activity to the judicial exception (See MPEP 2106.05(d)) and Berkheimer Memo.
Celentano (US 2010/0160860 A1) discloses a feedback device - a conventional liquid crystal display (para. [0043]), a conventional audible indication device 72, and a conventional vibratory device 74 (para. [0056], The UI processor 50 is generally operable to control the audible indication device 72 and the vibratory device 74 to produce one or more audible sounds and/or vibrations respectively to provide for the capability of the device 12 to produce corresponding audible and/or tactile notifications, i.e., alarms or the like) – to produce alarm notification.
Throckmorton (US 20160271309 A1) discloses a pump configured to be placed in a heart of a patient is well-understood, routine, and conventional (para. [0054], conventional blood pumps and ventricular assist devices).
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 28, 36, 42, and 44, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claim 46 is rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a controller for a mechanical circulatory support (MCS) device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 46 is directed towards a machine.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “generate an alert signal based, at least in part, on one or more physiological signals associated with a heart of a patient within which the MCS device is placed.”
The reason that the above limitation is considered an abstract idea is because it is directed to mental processes (observation, evaluation, judgment, opinion). The above step can be performed in the mind or by hand. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claims recite “at least one hardware computer processor” which can be interpreted as a generic processor. The processing device and the programmable processor do not integrate the judicial exception into a practical application, because it is merely using a generic processor as a tool to perform an abstract idea (see MPEP 2106.05(f)).
The claim also recites “transmit, in response to generating the alert signal, a control signal to a feedback device, wherein the feedback device is configured to provide sensory feedback to an operator of the MCS device based on the control signal.” Merely outputting sensory feedback using known, generic feedback device in response to an alert signal only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g).
The recitation is a use of generically recited computer element for its standard, well-known purpose, which does not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e).
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “at least one hardware computer processor” and “transmit, in response to generating the alert signal, a control signal to a feedback device, wherein the feedback device is configured to provide sensory feedback to an operator of the MCS device based on the control signal.”
The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, or as insignificant extra-solution activity to the judicial exception (See MPEP 2106.05(d)) and Berkheimer Memo.
Celentano (US 2010/0160860 A1) discloses a feedback device - a conventional liquid crystal display (para. [0043]), a conventional audible indication device 72, and a conventional vibratory device 74 (para. [0056], The UI processor 50 is generally operable to control the audible indication device 72 and the vibratory device 74 to produce one or more audible sounds and/or vibrations respectively to provide for the capability of the device 12 to produce corresponding audible and/or tactile notifications, i.e., alarms or the like) – to produce alarm notification.
Therefore, the claim is not patent eligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 9, 13, 14, 15, 17, 19, 22, 24, 28, 36, 44, and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moyer et al. (US 2021/0038793 A1).
Re Claim 1, Moyer discloses a method of providing sensory feedback to an operator of a mechanical circulatory support (MCS) device, the method comprising:
monitoring, using a controller of the MCS device, one or more physiological signals associated with a heart of a patient within which the MCS device is placed (para. [0057], The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure. The pressure signal waveform 302 and the LVP waveform 303 can be used by a healthcare professional to properly place an intravascular heart pump (such as intravascular heart pump 100 in FIG. 1) in the heart. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle.);
generating an alert signal based, at least in part, on the monitored one or more physiological signals (para. [0078], the controller can determine that there is a suction risk or a suction event based on current placement of the blood pump; para. [0079], The notification may indicate that there is a positioning problem; para. [0090], In addition to displaying the waveforms and cardiac metric values, the user interface may provide a warning and/or recommendations if a blood pump positioning problem is detected; para. [0057], The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform; para. [0068], warnings or alarms are triggered by a cardiac metric calculated, measured or monitored by the controller exceeding a set threshold value or falling below a set threshold value.); and
transmitting in response to generating the alert signal, a control signal from the controller of the MCS to a feedback device, wherein the feedback device is configured to provide sensory feedback to an operator of the MCS device based on the control signal (para. [0067], the display 300 in conjunction with an attached blood pump. The controller may issue warning notifications to a user regarding the use of the display, blood pump and related systems, or the cardiac metrics calculated by the controller. The warnings and alarms may be audible alarms, pop-up screens on the display 300, or may be sent directly to a clinician, for example through a text, page, or email; para. [0079], The notification may indicate that there is a positioning problem; para. [0090], In addition to displaying the waveforms and cardiac metric values, the user interface may provide a warning and/or recommendations if a blood pump positioning problem is detected).
Re Claim 24, Moyer discloses a mechanical circulatory support (MCS) device, comprising:
a pump configured to be placed in a heart of a patient (para. [0041], The motor 108 also drives a rotor (not visible in figure) which rotates to pump blood from the pump inlet 114 through the cannula 111 to the pump outlet 110.);
a feedback device configured to provide sensory feedback to an operator of the MCS device (para. [0067], the display 300 in conjunction with an attached blood pump. The warnings and alarms may be audible alarms, pop-up screens on the display 300, or may be sent directly to a clinician, for example through a text, page, or email); and
a controller configured to:
monitor one or more physiological signals associated with the heart of the patient during operation of the pump (para. [0057], The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure. The pressure signal waveform 302 and the LVP waveform 303 can be used by a healthcare professional to properly place an intravascular heart pump (such as intravascular heart pump 100 in FIG. 1) in the heart. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle.);
generate an alert signal based, at least in part, on the monitored one or more physiological signals (para. [0078], the controller can determine that there is a suction risk or a suction event based on current placement of the blood pump; para. [0079], The notification may indicate that there is a positioning problem; para. [0090], In addition to displaying the waveforms and cardiac metric values, the user interface may provide a warning and/or recommendations if a blood pump positioning problem is detected; para. [0057], The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform; para. [0068], warnings or alarms are triggered by a cardiac metric calculated, measured or monitored by the controller exceeding a set threshold value or falling below a set threshold value.); and
transmit in response to generating the alert signal, a control signal from the controller of the MCS to the feedback device, wherein the feedback device is configured to provide the sensory feedback based on the control signal (para. [0067], the display 300 in conjunction with an attached blood pump. The controller may issue warning notifications to a user regarding the use of the display, blood pump and related systems, or the cardiac metrics calculated by the controller. The warnings and alarms may be audible alarms, pop-up screens on the display 300, or may be sent directly to a clinician, for example through a text, page, or email; para. [0079], The notification may indicate that there is a positioning problem; para. [0090], In addition to displaying the waveforms and cardiac metric values, the user interface may provide a warning and/or recommendations if a blood pump positioning problem is detected).
Re Claim 46, Moyer discloses a controller for a mechanical circulatory support (MCS) device, the controller comprising:
at least one hardware computer processor (para. [0047], a processor within a blood pump controller; para. [0150], The processor 1408 includes software and/or hardware allowing it to receive the motor current and pressure measurements from the drive unit 1404) programmed to:
generate an alert signal based, at least in part, on one or more physiological signals associated with a heart of a patient within which the MCS device is placed (para. [0078], the controller can determine that there is a suction risk or a suction event based on current placement of the blood pump; para. [0079], The notification may indicate that there is a positioning problem; para. [0090], In addition to displaying the waveforms and cardiac metric values, the user interface may provide a warning and/or recommendations if a blood pump positioning problem is detected; para. [0057], The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform; para. [0068], warnings or alarms are triggered by a cardiac metric calculated, measured or monitored by the controller exceeding a set threshold value or falling below a set threshold value.); and
transmit, in response to generating the alert signal, a control signal to a feedback device, wherein the feedback device is configured to provide sensory feedback to an operator of the MCS device based on the control signal (para. [0067], the display 300 in conjunction with an attached blood pump. The controller may issue warning notifications to a user regarding the use of the display, blood pump and related systems, or the cardiac metrics calculated by the controller. The warnings and alarms may be audible alarms, pop-up screens on the display 300, or may be sent directly to a clinician, for example through a text, page, or email; para. [0079], The notification may indicate that there is a positioning problem; para. [0090], In addition to displaying the waveforms and cardiac metric values, the user interface may provide a warning and/or recommendations if a blood pump positioning problem is detected).
Re Claim 2, Moyer discloses that the one or more physiological signals include an electrocardiogram signal and/or a pressure signal sensed by at least one pressure sensor associated with the MCS device (para. [0057], The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure.).
Re Claim 5, Moyer discloses that generating the alert signal comprises generating the alert signal when it is determined based, at least in part, on the one or more physiological signals that the heart of the patient is in a systolic phase (fig. 5B, para. [0083], [0084], The determination of continuous or systolic suction events is informed by the LVP waveform 526 and aortic pressure waveform 524, indication of LVP 528, and indication of aortic pressure 532. By displaying these and other cardiac metrics to a user via the user interface 501, a user such as a clinician or physician can be aware of continuous suction events and can appropriately react to address them. Continuous suction events are typically caused by poor positioning of the blood pump or a cardiac structure blocking the blood pump inflow (e.g., pump inlet 114). During a continuous suction event, the LVP waveform 526 falls below zero during diastole and never rises above the aortic pressure waveform 524 during systole.).
Re Claim 9, Moyer discloses that the feedback device is a wearable device configured to be worn by the operator of the MCS device (para. [0130], the alarm can be sent, via a Wi-Fi network, blue tooth signal, or cellular signal, to a clinician by page, text, or email – Pager can be worn).
Re Claim 13, Moyer discloses that the feedback device (para. [0067], display 300) is coupled to a catheter (fig. 1, catheter 106, para. [0067], The menu button 326 may also allow a user to calibrate the display 300 or allow a user to access options or instructions for the calibration of the display 300 in conjunction with an attached blood pump) associated with the MCS device (fig. 1, heart pump system 100).
Re Claim 14, Moyer discloses that transmitting the control signal comprises wirelessly transmitting the control signal from the controller of the MCS device to the feedback device (para. [0130], the alarm can be sent, via a Wi-Fi network, blue tooth signal, or cellular signal, to a clinician by page, text, or email.).
Re Claim 15, Moyer discloses that generating the alert signal comprises generating the alert signal when it is determined based, at least in part, on the one or more physiological signals, that the MCS device is not in a desired position within the heart of the patient (para. [0057], The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure. The pressure signal waveform 302 and the LVP waveform 303 can be used by a healthcare professional to properly place an intravascular heart pump (such as intravascular heart pump 100 in FIG. 1) in the heart. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle.).
Re Claim 17, Moyer discloses that generating the alert signal comprises generating the alert signal when it is determined based, at least in part, on the one or more physiological signals, that the MCS device is in a desired position within the heart of the patient (para. [0057], The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure. The pressure signal waveform 302 and the LVP waveform 303 can be used by a healthcare professional to properly place an intravascular heart pump (such as intravascular heart pump 100 in FIG. 1) in the heart. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle.).
Re Claim 19, Moyer discloses that monitoring one or more physiological signals associated with a heart of a patient within which the MCS device is placed is performed during insertion of the MCS device into the heart of the patient (para. [0057], The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform.).
Re Claim 22, Moyer discloses receiving information associated with manipulation of the MCS device by the operator of the MCS device, wherein generating the alert signal is further based, at least in part, on the information associated with manipulation of the MCS device (para. [0057], The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform.).
Re Claim 28, Moyer discloses that generating the alert signal comprises generating the alert signal when it is determined based, at least in part, on the one or more physiological signals that the heart of the patient is in a systolic phase (fig. 5B, para. [0083], [0084], The determination of continuous or systolic suction events is informed by the LVP waveform 526 and aortic pressure waveform 524, indication of LVP 528, and indication of aortic pressure 532. By displaying these and other cardiac metrics to a user via the user interface 501, a user such as a clinician or physician can be aware of continuous suction events and can appropriately react to address them. Continuous suction events are typically caused by poor positioning of the blood pump or a cardiac structure blocking the blood pump inflow (e.g., pump inlet 114). During a continuous suction event, the LVP waveform 526 falls below zero during diastole and never rises above the aortic pressure waveform 524 during systole.).
Re Claim 36, Moyer discloses a catheter (para. [0041], a catheter 106), wherein the feedback device is coupled to the catheter (para. [0067], the display 300 in conjunction with an attached blood pump.).
Re Claim 44, Moyer discloses that the controller is further configured to: receive information associated with manipulation of the pump by the operator, wherein generating the alert signal is further based, at least in part, on the information associated with manipulation of the pump device (para. [0057], The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into an incorrect location in the ventricle. The pressure signal waveform 302 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 302 is an aortic or ventricular waveform.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (US 2021/0038793 A1) in view of Van der Helm (US 2011/0082445 A1).
Re Claim 6, Moyer discloses the claimed invention substantially as set forth in claim 1.
Moyer discloses that the feedback device is a pager (para. [0067], the display 300 in conjunction with an attached blood pump. The controller may issue warning notifications to a user regarding the use of the display, blood pump and related systems, or the cardiac metrics calculated by the controller. The warnings and alarms may be audible alarms, pop-up screens on the display 300, or may be sent directly to a clinician, for example through a text, page, or email).
Moyer is silent regarding wherein the sensory feedback includes tactile feedback.
However, Van der Helm discloses a medical device (abstract) and teaches an alarming unit that includes a tactile alarm generator such as a pager vibrator (para. [0027], [0065]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Moyer, by configuring the sensory feedback to include tactile feedback, as taught by Van der Helm, for the purpose of providing an alert through sensory feedback (para. [0027], [0065]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (US 2021/0038793 A1) in view of Almedhychy et al. (US 2022/0184377A1)
Re Claim 23, Moyer discloses the claimed invention substantially as set forth in claims 1 and 22.
Moyer is silent regarding training a machine learning (ML) model based on the information associated with manipulation of the MCS device to generate a trained ML model, wherein generating the alert signal is further based, at least in part, on an output of the trained ML model.
However, Almedhychy discloses monitoring one or more physiological signals associated with a heart of a patient within which the mechanical circulatory support device is placed (para. [0054], intracardiac blood pump assembly 506 is configured with electrical sensors 508 a and 510 a capable of sensing the electrical potential propagating through the heart during each heartbeat as described above with respect to FIG. 5.), generating an alert signal based, at least in part, on the monitored one or more physiological signals (para. [0055], [0059], The position of the intracardiac blood pump assembly 506 may be determined based (in whole or in part) on the time difference between the signals from electrical sensors 508 a and 510 a during a heartbeat. For example, if the time difference is too small, it may indicate that the intracardiac blood pump assembly 506 has folded back on itself such that the atraumatic tip is resting near the first portion 508 b of the left ventricle 502. Likewise, if the time difference is too big, it may indicate that the intracardiac blood pump assembly 506 has become kinked such that the atraumatic extension is wedged against the wall opposite the first portion 508 b of the left ventricle 502.); training a machine learning (ML) model based on the information associated with manipulation of the MCS device to generate a trained ML model, wherein generating the alert signal is further based, at least in part, on an output of the trained ML model (para. [0059], In addition, as typical shapes of ECG signals are generally known, the controller (e.g., controller 302) may be configured to compare the shape of one or both of the signals from electrical sensors 508 a and 510 a to the shape of an expected ECG signal in order to determine where electrical sensors 508 a and 510 a must be within the heart. This may be accomplished, for example, using computer modeling, neural networks trained to recognize ECG signals, etc.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Moyer, adding a step of training a machine learning (ML) model based on the information associated with manipulation of the MCS device to generate a trained ML model, wherein generating the alert signal is further based, at least in part, on an output of the trained ML model, as taught by Almedhychy, for the purpose of determining the position of the intracardiac blood pump assembly (para. [0055], [0059]).
Claims 20 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (US 2021/0038793 A1) in view of Nix et al. (US 6,176,822).
Re Claim 20, Moyer discloses the claimed invention substantially as set forth in claim 1.
Moyer discloses that generating an alert signal is further based, at least in part, on the determination that the MCS device is being repositioned in the heart of the patient (para. [0089], the display of the waveforms can be useful during a repositioning of a pump that has migrated into the left ventricle and that the separate LVP and aortic pressure waveforms can be viewed to confirm a distinct aortic pressure signal and can provide instantaneous feedback to the physician or technician during repositioning).
Moyer is silent regarding determining that the MCS device is being repositioned in the heart of the patient without reducing a pump speed of the MCS device, wherein generating an alert signal is further based, at least in part, on the determination that the MCS device is being repositioned in the heart of the patient without reducing the pump speed.
However, Nix discloses determining that the MCS device is being repositioned in the heart of the patient without reducing a pump speed of the MCS device, wherein generating an alert signal is further based, at least in part, on the determination that the MCS device is being repositioned in the heart of the patient without reducing the pump speed (col. 6, lines 25-48, Measuring the pressures and the differential pressures is important in particular for the insertion of the pump into the correct position in the heart. The insertion may be done with the pump at a standstill or running at a low rotational Speed while the heart is beating. When one pressure sensor detects the strongly pulsating pressure variation p1 and the other detects the weakly pulsating pressure variation p2, the pump is positioned correctly. However, measuring the pressure is not necessary for positioning. Rather, the positioning may also be monitored by means of the current variation of the pump. As long as the inlet and the outlet of a pump are in the same space, both are subjected to the same pressure. If the pump is driven with a certain rotational speed, the variation in time of the pump current is constant. If, however, the outlet and the inlet of the pump are in different spaces with pressures varying in time, no smooth, but a pulsating pump current will be obtained. Thus, it can be determined on the basis of the pump current, whether the cardiac valve correctly encloses the pump housing or the hose so that the inlet of the pump is located in the ventricle or the vestibule and the outlet is in the aorta or the pulmonary artery.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Moyer, by adding the step of determining that the MCS device is being repositioned in the heart of the patient without reducing a pump speed of the MCS device, wherein generating an alert signal is further based, at least in part, on the determination that the MCS device is being repositioned in the heart of the patient without reducing the pump speed, as taught by Nix, for the purpose of observing the pressures and pump current to determine that the pump is in the correct position in the heart (col. 6, lines 25-48).
Re Claim 42, Moyer discloses the claimed invention substantially as set forth in claim 24.
Moyer discloses that generating an alert signal is further based, at least in part, on the determination that the pump is being repositioned in the heart of the patient (para. [0089], the display of the waveforms can be useful during a repositioning of a pump that has migrated into the left ventricle and that the separate LVP and aortic pressure waveforms can be viewed to confirm a distinct aortic pressure signal and can provide instantaneous feedback to the physician or technician during repositioning).
Moyer is silent regarding the controller being further configured to: determine that the pump is being repositioned in the heart of the patient without reducing a pump speed of the pump, wherein generating an alert signal is further based, at least in part, on the determination that the pump is being repositioned in the heart of the patient without reducing the pump speed.
However, Nix discloses determining that the MCS device is being repositioned in the heart of the patient without reducing a pump speed of the MCS device, wherein generating an alert signal is further based, at least in part, on the determination that the MCS device is being repositioned in the heart of the patient without reducing the pump speed (col. 6, lines 25-48, Measuring the pressures and the differential pressures is important in particular for the insertion of the pump into the correct position in the heart. The insertion may be done with the pump at a standstill or running at a low rotational Speed while the heart is beating. When one pressure sensor detects the strongly pulsating pressure variation p1 and the other detects the weakly pulsating pressure variation p2, the pump is positioned correctly. However, measuring the pressure is not necessary for positioning. Rather, the positioning may also be monitored by means of the current variation of the pump. As long as the inlet and the outlet of a pump are in the same space, both are subjected to the same pressure. If the pump is driven with a certain rotational speed, the variation in time of the pump current is constant. If, however, the outlet and the inlet of the pump are in different spaces with pressures varying in time, no smooth, but a pulsating pump current will be obtained. Thus, it can be determined on the basis of the pump current, whether the cardiac valve correctly encloses the pump housing or the hose so that the inlet of the pump is located in the ventricle or the vestibule and the outlet is in the aorta or the pulmonary artery.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Moyer, by configuring the controller to determine that the pump is being repositioned in the heart of the patient without reducing a pump speed of the pump, wherein generating an alert signal is further based, at least in part, on the determination that the pump is being repositioned in the heart of the patient without reducing the pump speed, as taught by Nix, for the purpose of observing the pressures and pump current to determine that the pump is in the correct position in the heart (col. 6, lines 25-48).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (US 2021/0038793 A1) as modified by Nix et al. (US 6,176,822), and further in view of Mouchawar (US 6,009,349A).
Re Claim 21, Moyer as modified by Nix discloses the claimed invention substantially as set forth in claims 1 and 20.
Moyer and Nix are silent regarding determining that the MCS device is being repositioned in the heart of the patient without reducing a pump speed of the MCS device comprises detecting a femoral arterial pulse while the MCS device is operating.
However, Mouchawar discloses a processing system and method for deriving an improved hemodynamic indicator from cardiac wall acceleration signals (abstract) and teaches detecting a femoral arterial pulse (col. 5, FIG. 4 is a graph showing a direct arterial blood pressure signal (the upper channel) as measured in the femoral artery and a cardiac wall displacement signal (the lower channel) derived in accordance with the principles of the present invention, both plotted simultaneously as a function of time, each indicative of a subject in normal sinus rhythm; FIG. 5 is a graph showing a direct arterial blood pressure signal (the upper channel) as measured in the femoral artery and a cardiac wall displacement signal (the lower channel) derived in accordance with the principles of the present invention, both plotted simultaneously as a function of time, each indicative of a subject that first experienced fibrillation, and then hemodynamically unstable tachycardia induced by an unsuccessful defibrillation shock; FIG. 6 is a graph showing a direct arterial blood pressure signal (the upper channel) as measured in the femoral artery and a cardiac wall displacement signal (the lower channel) derived in accordance with the principles of the present invention, both plotted simultaneously as a function of time, each indicative of a subject that experienced fibrillation and a successful defibrillation shock; FIG. 7 is a graph showing a direct arterial blood pressure signal (the upper channel) as measured in the femoral artery and a cardiac wall displacement signal (the lower channel) derived in accordance with the principles of the present invention, both plotted simultaneously as a function of time, each indicative of a subject that experienced an ectopic heartbeat during normal sinus rhythm; col. 10, lines 52-63).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Moyer as modified by Nix, by configuring determining that the MCS device is being repositioned in the heart of the patient without reducing a pump speed of the MCS device to comprise detecting a femoral arterial pulse while the MCS device is operating, as taught by Mouchawar, for the purpose of detecting normal sinus rhythm, fibrillation, or an ectopic heartbeat during normal sinus rhythm (col. 5, fig. 4-fig. 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, June 22, 2026Examiner, Art Unit 3792
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