DETAILED ACTION
Applicant’s arguments, filed on 07/24/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 07/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 27-28,31-35 and 37-46 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 27, 32, 33, 35, 41, and 43 are objected to because of the following informalities:
In claim 27, “a signal representative of the cardiac cycle” should read “a signal representative of a cardiac cycle”
In claim 32, “the similarity” should read “a similarity”
In claim 33, “a multiple number of first signals” should read “a multiple number of the first signals”
In claim 35, “the heart rate signal representative of the cardiac cycle” should read “the signal representative of the cardiac cycle”
In claim 41, “a signal representative of the cardiac cycle” should read “a signal representative of a cardiac cycle”
In claim 43, “prior to combining combining” should read “prior to combining”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31, 33-34, 40, and 44-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 31, the claim recites the limitation “an average oscillation period”. It is unclear if this is the same oscillation period as the oscillation cycle introduced in claim 27, or a different period. If it is the same as the oscillation cycle from claim 27, it should read “the oscillation cycle”. If it is referring to a different oscillation period, it needs to be distinguished. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the oscillation cycle from claim 27.
Regarding claim 33, the claim recites the limitation “a number of sensors”. It is unclear if this is referring to the first sensor and the second sensor from claim 27, or different sensors. If it is referring to the sensors from claim 27, it needs to refer back to them. If it is referring to different sensors, it needs to be distinguished. For purposes of examination, it is being interpreted as referring to the sensors from claim 27.
Regarding claim 34, the claim recites the limitation “a time period”. It is unclear if this is referring to the time period from claim 27, or a different time period. If it is referring to the time period from claim 27, it needs to refer back to it. If it is referring to a different time period, it needs to be distinguished. For purposes of examination, it is being interpreted as referring to the time period from claim 27.
Further regarding claim 34, the claim recites the limitation “a corresponding oscillation cycle”. It is unclear if this is referring to the oscillation cycle from claim 27, or a different oscillation cycle. If it is referring to the oscillation cycle from claim 27, it needs to refer back to it. If it is referring to a different oscillation cycle, it needs to be distinguished. For purposes of examination, it is being interpreted as referring to the oscillation cycle from claim 27.
Regarding claim 40, the claim recites the limitation “a charge time of the device”. It is unclear how long a charge time of the device would be, making it unclear what the predetermined period of time is. Furthermore, the limitation is defined as a reference to a variable, which renders the claim indefinite. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any predetermined time period will teach on this limitation.
Regarding claim 44, the claim recites the limitation “an average oscillation period”. It is unclear if this is the same oscillation period as the oscillation cycle introduced in claim 41, or a different period. If it is the same as the oscillation cycle from claim 41, it should read “the oscillation cycle”. If it is referring to a different oscillation period, it needs to be distinguished. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the oscillation cycle from claim 41.
Regarding claim 45, the claim recites the limitation “a time period”. It is unclear if this is referring to the time period from claim 41, or a different time period. If it is referring to the time period from claim 41, it needs to refer back to it. If it is referring to a different time period, it needs to be distinguished. For purposes of examination, it is being interpreted as referring to the time period from claim 41.
Further regarding claim 45, the claim recites the limitation “a corresponding oscillation cycle”. It is unclear if this is referring to the oscillation cycle from claim 41, or a different oscillation cycle. If it is referring to the oscillation cycle from claim 41, it needs to refer back to it. If it is referring to a different oscillation cycle, it needs to be distinguished. For purposes of examination, it is being interpreted as referring to the oscillation cycle from claim 41.
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 27-28,31-35 and 37-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Under the two-step 101 analysis, the claims fail to satisfy the criteria for subject matter eligibility.
Regarding Step 1, claims 27-46 are all within at least one of the four statutory categories.
Claim 27 and its dependents disclose a device (machine).
Claim 41 and its dependents disclose a method.
Regarding Step 2A, Prong One, the independent claims 27 and 41 recite an abstract idea. In particular, the claims generally recite the following:
Receive the first signal and the signal representative of the cardiac cycle of the individual, wherein the first signal is a perfusion signal or a signal which is a measure of a volume of blood in the thoracic cavity of the individual;
Extract a plurality of frames from the first signal, each extracted frame of the plurality of extracted frames having an extracted frame length which is a time period determined from an oscillation cycle from the signal representative of the cardiac cycle of the individual;
Determine a magnitude of the first signal from the plurality of extracted frames, determining the magnitude comprising combining the plurality of frames to generate a combined frame and determining an amplitude of the combined frame.
These elements recites in claims 27 and 41 are drawn to abstract ideas since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgement, and opinion and using pen and paper.
Receiving the first signal and the signal representative of the cardiac cycle of the individual, wherein the first signal is a perfusion signal or a signal which is a measure of a volume of blood in the thoracic cavity of the individual is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably receive the first signal and a signal representative of the heart rate of the individual on paper. There is nothing to suggest an undue level of complexity in receiving the first signal and a signal representative of the heart rate from the individual.
Extracting a plurality of frames from the first signal, each extracted frame of the plurality of extracted frames having an extracted frame length which is a time period determined from an oscillation cycle from the signal representative of the cardiac cycle of the individual is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably take the first signal that they received on paper and divide it into frames based on an oscillation period of the heart rate signal. These techniques are based on algorithms, calculations, mathematical principles, evaluation, and judgement which can be performed by hand. The mathematics of dividing a signal into frames based on an oscillation period are not overly complicated to perform using pen and paper given enough time, therefore it is defined as an abstract idea. There is nothing to suggest an undue level of complexity in extracting a plurality of frames from the first signal, each extracted frame of the plurality of extracted frames having an extracted frame length which is a time period determined from an oscillation cycle from the signal representative of the cardiac cycle of the individual.
Determining a magnitude of the first signal from the plurality of extracted frames, determining the magnitude comprising combining the plurality of frames to generate a combined frame and determining an amplitude of the combined frame is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably determine a magnitude of the first signal from the plurality of extracted frames mentally or with the aid pf pen and paper. These techniques are based on algorithms, calculations, mathematical principles, evaluation, and judgement, which can be performed by hand. The mathematics of determining a magnitude of the first signal are not overly complicated to perform using pen and paper given enough time, therefore it is defined as an abstract idea. There is nothing to suggest an undue level of complexity in determining a magnitude of the first signal from the plurality of extracted frames, determining the magnitude comprising combining the plurality of frames to generate a combined frame and determining an amplitude of the combined frame.
Regarding Step 2A, Prong Two, claims 27 and 41 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are directed to the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a controller” and “a device”), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g., “a first sensor” and “a second sensor”) or insignificant post-solution activity (e.g., “the controller is further configured to output a third signal to the device for hemodynamic intervention based on the determined magnitude of the first signal”)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Regarding Step 2B, claims 27 and 41 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Claims 27 and 41 do not recite additional elements that amount to significantly more than the judicial exception itself. In particular, “a first sensor, configured to measure a first signal, wherein the first signal is a perfusion signal of an individual or a signal which is a measure of a volume of blood in the thoracic cavity of the individual” does not qualify as significantly more because this limitation merely describes a conventional sensor. Similarly, “a second sensor, configured to measure a signal representative of the cardiac cycle of the individual” also does not qualify as significantly more because this limitation merely describes a conventional sensor.
The data gathering step of “a first sensor, configured to measure a first signal, wherein the first signal is a perfusion signal of an individual or a signal which is a measure of a volume of blood in the thoracic cavity of the individual” is nothing more than a conventional sensor. Such sensors are evidenced by:
US Patent Application Publication No. 20070118187 (Denker) discloses sensors that measure blood volume as conventional (Denker, [0040]);
US Patent Application Publication No. 20090326342 (Huiku) discloses conventional sensors monitoring blood volume status (Huiku, [0136]);
US Patent Application Publication No. 20170020398 (Emadzadeh) discloses sensors measuring perfusion of blood as conventional (Emadzadeh, [0016]).
The data gathering step of “a second sensor, configured to measure a signal representative of the cardiac cycle of the individual” is nothing more than a conventional sensor. Such sensors are evidenced by:
US Patent No. 5980548 (Evans) discloses a sensor measuring cardiac cycle as conventional (Evans, Column 10, lines 62-64);
US Patent No. 5311867 (Kynor) discloses conventional sensors that gather cardiac cycle data (Kynor, Column 4, lines 10-11);
US Patent 4903704 (Van Eggermond) discloses a conventional heartbeat sensor for determining cardiac cycle parameters (Van Eggermond, Column 3, lines 43-45).
Further, the element of a controller in claims 27 and 41 does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above judicial exception. Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Regarding the dependent claims, claims 28, 30-35, and 37-40 depend on claim 27 and claims 42-46 depend on claim 41. The dependent claims merely further define the abstract idea or are additional data output that is well-understood, routine, and previously known to the industry.
For example, the following are dependent claims reciting abstract ideas and can be performed in the human mind:
(Claim 28): “wherein the device combined frame is an average frame” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 30): “configured to adjust the plurality of extracted frames to have the same frame length prior to combining the plurality of frames” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 31): “wherein the frame length is determined from an average oscillation period of the signal representative of the cardiac cycle of the individual” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 32): “configured to determine a confidence measure value which indicates the similarity of the plurality of extracted frames” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 33): “configured to receive a multiple number of first signals from a number of sensors and determine the magnitude of each of the first signals” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 34): “wherein the extracted frame length is a time period determined from a corresponding oscillation cycle from the signal representative of the cardiac cycle of the individual” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 35): “configured to correct for a difference in phase between the heart rate signal representative of the cardiac cycle of the individual and the first signal” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 37): “the control system according to claim 27, wherein the controller is further configured to output the third signal to activate the device for hemodynamic intervention when a magnitude of the signal representative of the cardiac cycle of the individual is above a first threshold value and the magnitude of the first signal is below a second threshold value” further describes insignificant post-solution activity. Furthermore, it is not described how this device functions or any structure of it;
(Claim 38): “wherein the device for hemodynamic intervention is an implantable device or an externally wearable device” further defines the abstract idea as it limits the type of device required, but does not add anything that incorporates it into a practical application;
(Claim 39): “wherein the first signal is a lead impedance signal” further defines the abstract idea by limiting the type of signal that can be received;
(Claim 40): “wherein the plurality of frames of the first signal are extracted over a charge time of the device” further defines the abstract idea as it limits the time period the signal is collected over;
(Claim 42): “wherein the combined frame is an average frame” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 43): “further comprising adjusting, by the controller, the plurality of extracted frames to have the same frame length prior to combining combining the plurality of frames” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 44): “wherein the frame length is determined from an average oscillation period of the signal representative of the cardiac cycle of the individual” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 45): “wherein the extracted frame length is a time period determined from a corresponding oscillation cycle from the signal representative of the cardiac cycle of the individual” is based in mathematical concept that can be performed mentally or with the aid of pen and paper. This technique is based on algorithms and calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 46): “a computer storage medium comprising code for execution by a processor, the code, when executed by the processor causing the processor to perform the method of claim 41” further describes insignificant pre-solution activity.
The dependent claims do not recite significantly more than the abstract ideas. Therefore, the claims 27-28,31-35 and 37-46 are rejected as being directed to non-statutory subject matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 27-28, 31-35, 37-38, 40-42, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis (US Patent Application Publication No. 20080208066) in further view of Bukkapatnam (US PG Pub 20140207005).
Regarding independent claim 27, Cinbis teaches a system ([0100]: “the device may also calculate a blood volume index, Block 410, and an oxygenation index, Block 412 that are utilized to provide input to a medical device concerning the hemodynamic status of the patient”) comprising:
a first sensor, configured to measure a first signal, wherein the first signal is a perfusion signal of an individual or a signal which is a measure of a volume of blood in the thoracic cavity of the individual ([0028]: “a sensor system and method for monitoring changes in tissue perfusion that is adaptable for use in medical devices”; [0028]: “Specifically, by determining if tissue oxygenation and/or blood volume is being maintained, the system and method can be used, along with other sensor measurements, to determine what action, if any, the implantable medical device should take”);
a second sensor, configured to measure a signal representative of the cardiac cycle of the individual ([0092]: “a heart rate monitor within the implanted device are evaluated to determine whether the patient is resting and has a normal heart rate.”);
a controller ([0039]: “Sensor processing unit 194 provides sensor data to microprocessor”), configured to:
receive the first signal and the signal representative of the cardiac cycle of the individual ([0046]: “a tissue perfusion sensor system 100 is illustrated schematically. The sensor system 100 includes at least two light sources 102, a light detector 104, and a sensor controller 106 … The sensor controller 106 receives the light measurements from the light detector and uses the measurements at the isobestic light source to calculate the volume index, which indicates the change from a baseline value in the percentage of the volume of the illuminated tissue that contains blood”);
extract a plurality of frames from the first signal ([0098]-[0099]; Fig. 4F), each extracted frame of the plurality of extracted frames having an extracted frame length which is a time period determined from an oscillation cycle from the signal representative of the cardiac cycle of the individual ([0098]-[0099]; Fig. 4F; [0099]: “As illustrated in FIG. 4F, the curve 527 represents measured amplitude of light as a function of time, from one light source, that passes through perfused tissue. The pulsing of the blood in the arteries and arterioles changes the volume of blood in the tissue for every heart beat. The result is that curve 527 has a pulsatile shape. Each pulse represents the time from one heart beat to the next, called the cardiac cycle 528. Each cardiac cycle has a maximum value and a minimum value. The difference between the maximum and the minimum is the AC pulse amplitude, 523. The measured waveform 527 also has an average DC value, 525, which is the average amplitude of all of the points of curve 527 during the cardiac cycle 528.”)
determine a magnitude of the first signal from the plurality of extracted frames and determining an amplitude of the combined frame ([0098]-[0099]; Fig. 4F, reference character “523”; [0100]: “The number of cardiac cycles or time periods utilized in Block 520 will depend upon what the user determines can be averaged to reduce the error in any one measurement and provide a value representative of the true AC and DC measures. According to one embodiment, for example, the light measurements are taken over ten cardiac cycles or ten one second time periods. Once the light measurements have been obtained for the predetermined number of cardiac or arterial cycles, or for the one second time periods, No in Block 520, the device calculates, from the 10 stored AC and DC amplitudes, an average or median AC pulse amplitude and average or median DC amplitude, Block 518, for each of the wavelengths, Block 522.”; [0100]: “The number of cardiac cycles or time periods utilized in Block 520 will depend upon what the user determines can be averaged to reduce the error in any one measurement and provide a value representative of the true AC and DC measures. According to one embodiment, for example, the light measurements are taken over ten cardiac cycles or ten one second time periods. Once the light measurements have been obtained for the predetermined number of cardiac or arterial cycles, or for the one second time periods, No in Block 520, the device calculates, from the 10 stored AC and DC amplitudes, an average or median AC pulse amplitude and average or median DC amplitude, Block 518, for each of the wavelengths, Block 522.”).
However, Cinbis does not teach determining the magnitude comprising combining the plurality of frames to generate a combined frame and determining an amplitude of the combined frame.
Bukkapatnam discloses a system for modeling cardiovascular dynamics. Specifically, Bukkapatnam teaches combining the plurality of frames to generate a combined frame ([0118]: “One approach to smoothing the model would be to utilize a simple average. In this particular approach, the previous frame, current frame, and next frame were averaged to get an interpolated plot”). Cinbis and Bukkapatnam are analogous arts as they are both related to monitoring cardiovascular functions of the user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the combined frame from Bukkapatnam into the system from Cinbis as it helps to smooth the model, which can provide a more accurate and comprehensive analysis for the user.
The Cinbis/Bukkapatnam combination teaches a device for hemodynamic intervention (Cinbis, [0034]: “the present invention may be employed in a device that provides only one therapy, such as a high power defibrillation therapy, for example.”; [0033]: “The tissue perfusion sensing system and method is particularly applicable to implantable medical devices. In particular, because the system and method can be implemented in a relatively simple device with relatively simple processing it lends itself to applications such as implantable cardiac devices”; [0045]: “The device 14 can be programmed to attempt to deliver cardioversion shocks to the heart in the manners described above in timed synchrony with a detected R-wave or can be programmed or fabricated to deliver defibrillation shocks to the heart in the manners described above without attempting to synchronize the delivery to a detected R-wave.”), wherein the controller is further configured to output a third signal to the device for hemodynamic intervention based on the determined magnitude of the first signal (Cinbis, [0146]: “The measurement of perfusion is used to help distinguish between a tolerated ventricular tachyarrhythmia (VT) and an untolerated VT. In general, a VT event is where the heart beats are much faster than normal sinus rhythm and the origin of the rapid beats are within ventricles. An untolerated VT will cause syncope of the patient due to inadequate perfusion of the brain. In an untolerated VT, it is desirable to shock the patient to alleviate the tachyarrhythmia, while in a tolerated VT this is generally not desirable or necessary. Since ECG signal does not tell anything about mechanical performance of the heart as a pump, it is difficult for the implanted device to distinguish between these types of events based solely on ECG signals. However, a tolerated VT typically does not result in a substantial drop in perfusion, while an untolerated VT does. Thus, the perfusion sensor can provide information to the implanted cardiac device to distinguish between VT events.”; [0133]: “when it is determined that the change exceeds the threshold, the medical device determines what action to take. Again, in one specific example the change can be used to determine whether or not defibrillation is desirable.”; [0110]: “Block 412 that are utilized to provide input to a medical device concerning the hemodynamic status of the patient, according to an embodiment of the invention. This input may be used, for example, to improve the sensing capability of a defibrillator.”).
Regarding claim 28, the Cinbis/Bukkapatnam combination teaches the system according to claim 27, wherein the combined frame is an average frame (Bukkapatnam, [0118]: “One approach to smoothing the model would be to utilize a simple average. In this particular approach, the previous frame, current frame, and next frame were averaged to get an interpolated plot”).
Regarding claim 31, the Cinbis/Bukkapatnam combination teaches the system according to claim 27, wherein the frame length is determined from an average oscillation period of the signal representative of the cardiac cycle of the individual (Cinbis, [0100]: “The number of cardiac cycles or time periods utilized in Block 520 will depend upon what the user determines can be averaged to reduce the error in any one measurement and provide a value representative of the true AC and DC measures. According to one embodiment, for example, the light measurements are taken over ten cardiac cycles or ten one second time periods. Once the light measurements have been obtained for the predetermined number of cardiac or arterial cycles, or for the one second time periods, No in Block 520, the device calculates, from the 10 stored AC and DC amplitudes, an average or median AC pulse amplitude and average or median DC amplitude, Block 518, for each of the wavelengths, Block 522.”; Fig. 4F).
Regarding claim 32, the Cinbis/Bukkapatnam combination teaches the system according to claim 28, wherein the controller is further configured to determine a confidence measure value which indicates the similarity of the plurality of extracted frames (Cinbis, [0104]: “A standard deviation or percentile of the current light measurements is determined for each light source and a variation between the determined standard deviations is utilized to generate an AC vibration amplitude for each of the wavelengths, i.e., light sources”).
Regarding claim 33, the Cinbis/Bukkapatnam combination teaches the system according to claim 27, wherein the controller is configured to receive a multiple number of first signals from a number of sensors and determine the magnitude of each of the first signals (Cinbis, [0029]: “the tissue perfusion sensor system includes at least two light sources and a light detector”; Fig. 3, reference characters “302”, “304”, and “305”. Multiple light sources means there are multiple first signals.; [0100]: “The number of cardiac cycles or time periods utilized in Block 520 will depend upon what the user determines can be averaged to reduce the error in any one measurement and provide a value representative of the true AC and DC measures. According to one embodiment, for example, the light measurements are taken over ten cardiac cycles or ten one second time periods. Once the light measurements have been obtained for the predetermined number of cardiac or arterial cycles, or for the one second time periods, No in Block 520, the device calculates, from the 10 stored AC and DC amplitudes, an average or median AC pulse amplitude and average or median DC amplitude, Block 518, for each of the wavelengths, Block 522.”; Fig. 4F).
Regarding claim 34, the Cinbis/Bukkapatnam combination teaches the system according to claim 27, wherein the extracted frame length is a time period determined from a corresponding oscillation cycle from the signal representative of the cardiac cycle of the individual (Cinbis, [0098]-[0099]; Fig. 4F; [0099]: “As illustrated in FIG. 4F, the curve 527 represents measured amplitude of light as a function of time, from one light source, that passes through perfused tissue. The pulsing of the blood in the arteries and arterioles changes the volume of blood in the tissue for every heart beat. The result is that curve 527 has a pulsatile shape. Each pulse represents the time from one heart beat to the next, called the cardiac cycle 528. Each cardiac cycle has a maximum value and a minimum value. The difference between the maximum and the minimum is the AC pulse amplitude, 523. The measured waveform 527 also has an average DC value, 525, which is the average amplitude of all of the points of curve 527 during the cardiac cycle 528.”).
Regarding claim 35, the Cinbis/Bukkapatnam combination teaches the system according to claim 27, wherein the controller is further configured to correct for a difference in phase between the heart rate signal representative of the cardiac cycle of the individual and the first signal (Cinbis, [0101]: “Once the average AC pulse amplitude and the average DC amplitude are determined, Block 522, the device determines a gain coefficient for each of the light sources, Block 524, using the average AC pulse amplitude determined in Block 522 and a determined baseline AC pulse amplitude, and an offset coefficient, Block 526 for each of the light sources, using the current average DC amplitude determined in Block 522 and a baseline DC amplitude, Block 526. … The offset coefficient B is calculated for each wavelength using the difference between the product of the current determined gain coefficient M and the current average DC amplitude determined in Block 522 and the baseline DC amplitude. Thus the determination of the gain coefficient M, Block 524, and the offset coefficient B, Block 526, can be made using Equations 2 and 3, respectively, set forth below”; [0102]: “Once the gain coefficient M and the offset coefficient B have been determined separately for each of the light sources, the device utilizes the normalization coefficients M and B to correct the respective light measurements subsequently made for each of the light sources for tissue encapsulation”. The offset coefficient is used to correct different phases of the signals if necessary.”).
Regarding claim 37, the Cinbis/Bukkapatnam combination teaches the system according to claim 27, wherein the controller is further configured to output the third signal to activate the device for hemodynamic intervention when a magnitude of the signal representative of the cardiac cycle of the individual is above a first threshold value and the determined magnitude of the first signal is below a second threshold value (Cinbis, [0146]: “The measurement of perfusion is used to help distinguish between a tolerated ventricular tachyarrhythmia (VT) and an untolerated VT. In general, a VT event is where the heart beats are much faster than normal sinus rhythm and the origin of the rapid beats are within ventricles. An untolerated VT will cause syncope of the patient due to inadequate perfusion of the brain. In an untolerated VT, it is desirable to shock the patient to alleviate the tachyarrhythmia, while in a tolerated VT this is generally not desirable or necessary. Since ECG signal does not tell anything about mechanical performance of the heart as a pump, it is difficult for the implanted device to distinguish between these types of events based solely on ECG signals. However, a tolerated VT typically does not result in a substantial drop in perfusion, while an untolerated VT does. Thus, the perfusion sensor can provide information to the implanted cardiac device to distinguish between VT events.”; [0133]: “when it is determined that the change exceeds the threshold, the medical device determines what action to take. Again, in one specific example the change can be used to determine whether or not defibrillation is desirable.”).
Regarding claim 38, the Cinbis/Bukkapatnam combination teaches the system according to claim 37, wherein the device for hemodynamic intervention is an implantable device or an externally wearable device (Cinbis, [0028]: “The invention provides a sensor system and method for monitoring changes in tissue perfusion that is adaptable for use in medical devices, including implantable and external medical devices.”).
Regarding claim 40, the Cinbis/Bukkapatnam combination teaches the system according to claim 38, wherein the plurality of frames are extracted over a charge time of the device for hemodynamic intervention ([0098]: “the measurements could be taken over a predetermined time period”).
Regarding independent claim 41, Cinbis teaches a method ([0028]: “The invention provides a sensor system and method for monitoring changes in tissue perfusion that is adaptable for use in medical devices, including implantable and external medical devices.” )comprising:
receiving, by a controller ([0039]: “Sensor processing unit 194 provides sensor data to microprocessor”), a first signal from a first sensor, wherein the first signal is a perfusion signal of an individual or a signal which is a measure of a volume of blood in the thoracic cavity of the individual ([0028]: “a sensor system and method for monitoring changes in tissue perfusion that is adaptable for use in medical devices”; [0028]: “Specifically, by determining if tissue oxygenation and/or blood volume is being maintained, the system and method can be used, along with other sensor measurements, to determine what action, if any, the implantable medical device should take”),
receiving, by the controller, a signal representative of the cardiac cycle of the individual, from a second sensor ([0092]: “a heart rate monitor within the implanted device are evaluated to determine whether the patient is resting and has a normal heart rate.”);
extracting, by the controller, a plurality of frames from the first signal ([0098]-[0099]; Fig. 4F), each extracted frame of the plurality of extracted frames having an extracted frame length which is a time period determined from an oscillation cycle from the signal representative of the cardiac cycle of the individual ([0098]-[0099]; Fig. 4F; [0099]: “As illustrated in FIG. 4F, the curve 527 represents measured amplitude of light as a function of time, from one light source, that passes through perfused tissue. The pulsing of the blood in the arteries and arterioles changes the volume of blood in the tissue for every heart beat. The result is that curve 527 has a pulsatile shape. Each pulse represents the time from one heart beat to the next, called the cardiac cycle 528. Each cardiac cycle has a maximum value and a minimum value. The difference between the maximum and the minimum is the AC pulse amplitude, 523. The measured waveform 527 also has an average DC value, 525, which is the average amplitude of all of the points of curve 527 during the cardiac cycle 528.”);
determining, by the controller, a magnitude of the first signal from the plurality of extracted frames and determining an amplitude of the combined frame ([0098]-[0099]; Fig. 4F, reference character “523”; [0100]: “The number of cardiac cycles or time periods utilized in Block 520 will depend upon what the user determines can be averaged to reduce the error in any one measurement and provide a value representative of the true AC and DC measures. According to one embodiment, for example, the light measurements are taken over ten cardiac cycles or ten one second time periods. Once the light measurements have been obtained for the predetermined number of cardiac or arterial cycles, or for the one second time periods, No in Block 520, the device calculates, from the 10 stored AC and DC amplitudes, an average or median AC pulse amplitude and average or median DC amplitude, Block 518, for each of the wavelengths, Block 522.”; [0100]: “The number of cardiac cycles or time periods utilized in Block 520 will depend upon what the user determines can be averaged to reduce the error in any one measurement and provide a value representative of the true AC and DC measures. According to one embodiment, for example, the light measurements are taken over ten cardiac cycles or ten one second time periods. Once the light measurements have been obtained for the predetermined number of cardiac or arterial cycles, or for the one second time periods, No in Block 520, the device calculates, from the 10 stored AC and DC amplitudes, an average or median AC pulse amplitude and average or median DC amplitude, Block 518, for each of the wavelengths, Block 522.”).
However, Cinbis does not teach determining the magnitude comprising combining the plurality of frames to generate a combined frame and determining an amplitude of the combined frame.
Bukkapatnam discloses a system for modeling cardiovascular dynamics. Specifically, Bukkapatnam teaches combining the plurality of frames to generate a combined frame ([0118]: “One approach to smoothing the model would be to utilize a simple average. In this particular approach, the previous frame, current frame, and next frame were averaged to get an interpolated plot”). Cinbis and Bukkapatnam are analogous arts as they are both related to monitoring cardiovascular functions of the user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the combined frame from Bukkapatnam into the method from Cinbis as it helps to smooth the model, which can provide a more accurate and comprehensive analysis for the user.
The Cinbis/Bukkapatnam combination teaches outputting a third signal to a device for hemodynamic intervention based on the determined magnitude (Cinbis, [0034]: “the present invention may be employed in a device that provides only one therapy, such as a high power defibrillation therapy, for example.”; [0033]: “The tissue perfusion sensing system and method is particularly applicable to implantable medical devices. In particular, because the system and method can be implemented in a relatively simple device with relatively simple processing it lends itself to applications such as implantable cardiac devices”; [0045]: “The device 14 can be programmed to attempt to deliver cardioversion shocks to the heart in the manners described above in timed synchrony with a detected R-wave or can be programmed or fabricated to deliver defibrillation shocks to the heart in the manners described above without attempting to synchronize the delivery to a detected R-wave.”; [0146]: “The measurement of perfusion is used to help distinguish between a tolerated ventricular tachyarrhythmia (VT) and an untolerated VT. In general, a VT event is where the heart beats are much faster than normal sinus rhythm and the origin of the rapid beats are within ventricles. An untolerated VT will cause syncope of the patient due to inadequate perfusion of the brain. In an untolerated VT, it is desirable to shock the patient to alleviate the tachyarrhythmia, while in a tolerated VT this is generally not desirable or necessary. Since ECG signal does not tell anything about mechanical performance of the heart as a pump, it is difficult for the implanted device to distinguish between these types of events based solely on ECG signals. However, a tolerated VT typically does not result in a substantial drop in perfusion, while an untolerated VT does. Thus, the perfusion sensor can provide information to the implanted cardiac device to distinguish between VT events.”; [0133]: “when it is determined that the change exceeds the threshold, the medical device determines what action to take. Again, in one specific example the change can be used to determine whether or not defibrillation is desirable.”; [0110]: “Block 412 that are utilized to provide input to a medical device concerning the hemodynamic status of the patient, according to an embodiment of the invention. This input may be used, for example, to improve the sensing capability of a defibrillator.”).
Regarding claim 42, the Cinbis/Bukkapatnam combination teaches the method according to claim 41, wherein the combined frame is an average frame (Bukkapatnam