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 .
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.
Applicant's response, filed on 07/02/2025, has 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.
Status of Claims
Claims 1-12 and 14-20 are pending. Claims 1, 3-5, 11, 14-15 are amended. Claim 13 is canceled. Claims 1-12 and 14-20 are examined below.
Priority
As detailed on the 04/05/2023 filing receipt, this application claims domestic priority to as early as 02/01/2020.
Drawings
The drawings filed 02/11/2021 are accepted.
Withdrawn Rejections/Objections
The rejection of claims 1-12 and 14-20 under 35 U.S.C. §101, in the Office action mailed 04/17/2025 is withdrawn in view of the amendments filed 07/02/2025.
The rejection of claims 1-3 under 35 U.S.C. §102(a)(2) over Lopez-Perez ("Personalized cardiac computational models: from clinical data to simulation of infarct-related ventricular tachycardia. "Frontiers in physiology 10 (2019): 580., published 2019; as cited on the attached "Notice of References Cited" 892 form), in the Office action mailed 04/17/2025 is withdrawn in view of the amendments filed 07/02/2025. However, a new rejection is applied.
The rejection of claims 4-20 under 35 U.S.C. §103(a) over Lopez-Perez ("Personalized cardiac computational models: from clinical data to simulation of infarct-related ventricular tachycardia. "Frontiers in physiology 10 (2019): 580., published 2019; as cited on the attached "Notice of References Cited" 892 form) as applied to claims 1-3 above, in view of Yang (US Patent Application 2019/0053728 A1, published Feb. 21, 2019; cited on the 11/30/2023 IDS Document), in the Office action mailed 04/17/2025 is withdrawn in view of the amendments filed 07/02/2025. However, a new rejection is applied.
The rejection of claims 1-20 as being provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 12-14, 16, 19 and 21 of copending Application No. 17174308 in view of Lopez-Perez and Yang, in the Office action mailed 04/17/2025 is withdrawn in view of Notice of Abandonment dated 10/04/2024.
The rejection of claims 1-20 as being provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 12 of copending Application No. 17372470 in view of Lopez-Perez and Yang, in the Office action mailed 04/17/2025 is withdrawn in view of the amendments filed 07/02/2025. However, a new rejection is applied.
Regarding 35 USC 101
Claims 1-12 and 14-20 are patent-eligible under 35 U.S.C. 101 because independent claim 1 recites “…delivering, based on the patient-specific 3D localization of the arrhythmia and the patient-specific cardiac activation map ablation therapy to a localization point of the arrhythmia activation in a heartbeat” and independent claim 11 recites “…displaying the patient-specific 3D localization of the arrhythmia and the patient- specific cardiac activation map during a medical procedure that applies an ablation therapy to a localization point of the arrhythmia activation based on the patient- specific 3D localization of the arrhythmia and the patient-specific cardiac activation map.” The claims are implementing a judicial exception with, or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Therefore, the judicial exception is integrated into a practical application under Step 2A, 2nd prong of the 101 analysis.
Claim Rejections - 35 USC § 102
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, 4, 6-12, 14, 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adler (US 2018/0303345 A1, Publication Date Oct. 25, 2018; Filed April. 18, 2018 as cited on the 06/10/2021 IDS Document). Any newly recited rejections are necessitated by claim amendments.
Regarding independent claim 1, Adler teaches selecting a 3D heart electrical conduction model from a database of representative 3D heart models based on patient demographic information, the selected 3D heart electrical conduction model including a 3D surface model with “In various embodiments, a cardiac imaging method may include recording electrocardiogram (ECG) data of a patient having an episodic cardiac condition using a portable ECG recorder for a time period sufficient for symptoms of the episodic cardiac condition to occur, providing patient data comprising the recorded ECG data to a processing unit, generating, by the processing unit, a three-dimensional (3D) activation map showing the propagation of electrical signals through the patient's heart based on the provided patient data, and displaying, by the processing unit, an ablation point on the 3D activation map, the ablation point being selected to alleviate the episodic cardiac condition. In some embodiments, the patient data provided to the processing unit may further include computed tomography (CT) or magnetic resonance imaging (MRI) data of the patient's heart and 3D image data of the patient's chest. In some embodiments, the time period may range from about 12 hours to about 48 hours. In some embodiments, the portable ECG recorder may include a 12-lead ECG recorder comprising 10 electrodes. In some embodiments, displaying the ablation point may include displaying multiple ablation points.” ([0010]); “In the example illustrated in FIG. 3A, the heart 1 is stimulated beginning at an earliest activation location 10. From the earliest activation location 10, the electrical signals will travel through the heart tissue. Hence, different parts of the heart will be activated at different times. Each location on the heart has a particular delay relative to the initial stimulation. Each node 8 has associated therewith a value representative of a time delay between stimulation of the heart 1 at the earliest activation location 10 and activation of the heart at that respective node 8. In the example illustrated in FIG. 3A, locations that share the same delay time are connected by isochrones 12. As used herein, isochrones are lines drawn on a 3D heart surface model connecting points on this model at which the activation occurs or arrives at the same time. The delay time for nodes across the heart surface in this example is also displayed by differing rendering shades. The vertical bar indicates the time delay in milliseconds associated with the respective shade. It will be appreciated that the stimulation location 10 can be the location of intrinsic activation of the heart 1.” ([0048]) and with “The 3D model 4 may also include further information. For example, the 3D model 4 may include cardiac blood vessels 14 and/or veins on the myocardium. This information may be added to the 3D model 4 in that nodes are indicated as being associated with such blood vessel. The blood vessels 14 may then be identified and optionally shown in the 3D model 4. Optionally, the processing unit 400 may include a first recognition unit arranged for automatically retrieving information representative of the location of such blood vessels from the patient's 3D anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0049]).
Adler teaches obtaining a 3D image of electrocardiographic (ECG) electrodes on a torso of the patient using a 3D camera with “FIG. 2A is a block diagram of a cardiac imaging system 200 according to various embodiments. Referring to FIG. 2A, the imaging system 200 may include a processing unit 400, a CT or MRI device 108, a 3D camera 109, and an ECG recorder 106. The cardiac imaging system 200 may also include a real-time imaging device 328 and a display 330. The CT/MRI device 108 may be configured to generate a 3D model of the chest and/or heart of the patient. The 3D camera 109 may be configured to generate a 3D image of the patient's torso. The ECG recorder 106 may be configured to record ECD data from the patient, which may include extrinsic and/or intrinsic stimulation signals..” ([0030]).
Adler teaches merging the 3D image of the patient's torso with the selected 3D heart electrical conduction model by aligning locations of ECG electrodes in the selected 3D heart electrical conduction model with corresponding ECG electrodes in the 3D image with “FIG. 2A is a block diagram of a cardiac imaging system 200 according to various embodiments. Referring to FIG. 2A, the imaging system 200 may include a processing unit 400, a CT or MRI device 108, a 3D camera 109, and an ECG recorder 106. The cardiac imaging system 200 may also include a real-time imaging device 328 and a display 330. The CT/MRI device 108 may be configured to generate a 3D model of the chest and/or heart of the patient. The 3D camera 109 may be configured to generate a 3D image of the patient's torso. The ECG recorder 106 may be configured to record ECD data from the patient, which may include extrinsic and/or intrinsic stimulation signals.” ([0030]) and with “In some embodiments, the method may optionally include additional operations 510, 512, and 514. In operation 510, the activation map may be used to guide the positioning of a cardiac catheter to an ablation location and/or to guide diagnostic electrodes to appropriate locations on the heart, in real time. The patient's heart may then be ablated at the ablation location in operation 510.” ([0044]).
Adler teaches generating a patient-specific 3D localization of an arrhythmia based on the selected 3D electrical conduction model and electrocardiographic (ECG) data; generating a patient-specific cardiac activation map based the 3D electrical conduction model and ECG data with “Various embodiments provide a cardiac imaging system and method that includes using a portable electrocardiogram (ECG) recorder to record ECG data of a patient having an episodic cardiac condition for a time period sufficient for symptoms of the episodic cardiac condition to occur. The recorded ECG data may be provided to a processing unit along with other patient data. The processing unit may generate a three-dimensional (3D) activation map showing the propagation of electrical signals through the patient's heart. Based on the provided patient data, the processing unit may display an ablation point on the 3D activation map, the ablation point being configured to alleviate the episodic cardiac condition.” (Abstract).
Adler teaches merging the patient-specific 3D localization of the arrhythmia and the 3D surface model to generate a 3D arrhythmia activation surface model with “The processing unit 400 may include an image integrator 326, which may be connected to a real-time imaging device 328, such as a fluoroscope, a radiography device, an X-ray computed tomography (CT) device, or the like. The image integrator 326 may compare and/or align the activation map and real-time images provided by the imaging device 328. Based on the comparison and/or alignment, the ablation point(s) may be added to the real-time images as virtual ablation point(s) to produce modified real-time images. The modified real-time images may be provided to and presented on a display 330.” ([0032]) and with “The 3D model 4 may also include information on scar tissue. Scar tissue locations may be obtained from delayed enhancement MRI images and added to the 3D model 4. Scar tissue may be simulated in the 3D model 4 by reducing the propagation velocity of electrical signals there through. Scar tissue may also be accounted for by selling the transition from one node to another to very slow or non-transitional for the areas in the heart wall where scar tissue is present. Optionally, the processing unit 400 may include a second recognition unit arranged for automatically retrieving information representative of the location of such scar tissue from the patient-specific three-dimensional anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0050]).
Adler teaches delivering, based on the patient-specific 3D localization of the arrhythmia and the patient-specific cardiac activation map ablation therapy to a localization point of the arrhythmia activation in a heartbeat with “In some embodiments, the method may optionally include additional operations 510, 512, and 514. In operation 510, the activation map may be used to guide the positioning of a cardiac catheter to an ablation location and/or to guide diagnostic electrodes to appropriate locations on the heart, in real time. The patient's heart may then be ablated at the ablation location in operation 510.” (para. [0044]).
Regarding claim 2, Adler teaches wherein the patient demographic information includes one or more of the patient's gender, age, weight, height, body mass index, waist circumference, chest circumference, or underlying etiology with “Some heart defects in the conduction system result in asynchronous contraction (arrhythmia) of the heart and are sometimes referred to as conduction disorders. As a result, the heart does not pump enough blood, which may ultimately lead to heart failure. Conduction disorders can have a variety of causes, including age, heart (muscle) damage, medications and genetics.” ([0002]).
Regarding claim 4, Adler teaches wherein merging the patient-specific 3D localization of the arrhythmia and the 3D surface model to generate a 3D arrhythmia activation surface model comprises aligning locations of ECG electrodes used in generating patient-specific electrical conduction map of a patient's heart with the ECG electrodes within the 3D image with “FIG. 2A is a block diagram of a cardiac imaging system 200 according to various embodiments. Referring to FIG. 2A, the imaging system 200 may include a processing unit 400, a CT or MRI device 108, a 3D camera 109, and an ECG recorder 106. The cardiac imaging system 200 may also include a real-time imaging device 328 and a display 330. The CT/MRI device 108 may be configured to generate a 3D model of the chest and/or heart of the patient. The 3D camera 109 may be configured to generate a 3D image of the patient's torso. The ECG recorder 106 may be configured to record ECD data from the patient, which may include extrinsic and/or intrinsic stimulation signals.” ([0030]) and with “In some embodiments, the method may optionally include additional operations 510, 512, and 514. In operation 510, the activation map may be used to guide the positioning of a cardiac catheter to an ablation location and/or to guide diagnostic electrodes to appropriate locations on the heart, in real time. The patient's heart may then be ablated at the ablation location in operation 510.” ([0044]).
Regarding claim 6, Adler teaches wherein the arrhythmia is a ventricular arrhythmia with “In some embodiments, the episodic cardiac condition may include ventricular tachycardia (VT) or premature ventricular contraction (PVC). In some embodiments, displaying an ablation point may include displaying a location on the heart where the PVC occurs, or a location on the heart where the onset of the VT occurs.” ([0014])
Regarding claim 7, Adler teaches wherein the ventricular arrhythmia is a pre-ventricular contraction (PVC) with “Premature Ventricular Contractions (PVCs) are abnormal or aberrant heart beats that start somewhere in the heart ventricles rather than a normal sinus beat that starts from the upper chambers of the heart. PVCs typically result in a lower cardiac output heart beat because the ventricles contract before they have had the chance to completely fill with blood, which may be symptomatic. PVCs may also trigger Ventricular Tachycardia (VT or V-Tach .” ([0003])
Regarding claim 8, Adler teaches wherein the ventricular arrhythmia is a ventricular tachycardia with “Ventricular tachycardia (VT or V-Tach) is a heart arrhythmia disorder caused by abnormal electrical signals in the heart ventricles. In VT, the abnormal electrical signals cause the heart to beat faster than normal, usually more than 100 beats per minute, with the beats starting in the heart ventricles.” ([0004])
Regarding claim 9, Adler teaches using the patent's demographic information and the patient-specific 3D heart model to create a new 3D heart model for inclusion in the database of representative 3D heart models with “The 3D model 4 may also include further information. For example, the 3D model 4 may include cardiac blood vessels 14 and/or veins on the myocardium. This information may be added to the 3D model 4 in that nodes are indicated as being associated with such blood vessel. The blood vessels 14 may then be identified and optionally shown in the 3D model 4. Optionally, the processing unit 400 may include a first recognition unit arranged for automatically retrieving information representative of the location of such blood vessels from the patient's 3D anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0049]) and with “The 3D model 4 may also include information on scar tissue. Scar tissue locations may be obtained from delayed enhancement MRI images and added to the 3D model 4. Scar tissue may be simulated in the 3D model 4 by reducing the propagation velocity of electrical signals there through. Scar tissue may also be accounted for by selling the transition from one node to another to very slow or non-transitional for the areas in the heart wall where scar tissue is present. Optionally, the processing unit 400 may include a second recognition unit arranged for automatically retrieving information representative of the location of such scar tissue from the patient-specific three-dimensional anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0050]).
Regarding claim 10, Adler teaches using the patent's demographic information and the patient-specific 3D heart model to adjusting a 3D heart model in the database of representative 3D heart models with “In various embodiments, a cardiac imaging method may include recording electrocardiogram (ECG) data of a patient having an episodic cardiac condition using a portable ECG recorder for a time period sufficient for symptoms of the episodic cardiac condition to occur, providing patient data comprising the recorded ECG data to a processing unit, generating, by the processing unit, a three-dimensional (3D) activation map showing the propagation of electrical signals through the patient's heart based on the provided patient data, and displaying, by the processing unit, an ablation point on the 3D activation map, the ablation point being selected to alleviate the episodic cardiac condition. In some embodiments, the patient data provided to the processing unit may further include computed tomography (CT) or magnetic resonance imaging (MRI) data of the patient's heart and 3D image data of the patient's chest. In some embodiments, the time period may range from about 12 hours to about 48 hours. In some embodiments, the portable ECG recorder may include a 12-lead ECG recorder comprising 10 electrodes. In some embodiments, displaying the ablation point may include displaying multiple ablation points.” ([0010]).; “Some embodiments may further include ablating the heart at the displayed ablation location. Such embodiments may further include generating an updated 3D activation map of the heart after the ablating of the heart. Such embodiments may further include determining, based on the updated 3D activation map, whether a desired synchronization of the heart was achieved.” ([0015]) and with “In operation 512, an updated 3D activation map may be generated showing the results of the ablations performed in operation 510. For example, the updated activation map may be generated using ECG data collected after ablation is performed. Such ECG data may be collected during the procedure or afterwards, such as using a portable ECG recorder, such as a Holter-type ECG recorder, as in operation 500. The updated activation map may then be used to determine cardiac synchronicity” ([0045]).
Regarding independent claim 11, Adler teaches A computing system, comprising: a memory having stored thereon a database of representative three-dimensional (3D) heart models; and a processor coupled to the memory and configured with processor-executable instructions to perform operations with “In one or more aspects, the functions described may be implemented in hardware, software, firmware, or any combination thereof If implemented in software, the functions may be stored as one or more instructions or code on a non-transitory computer-readable storage medium or non-transitory processor-readable storage medium. The operations of a method or algorithm disclosed herein may be embodied in a processor-executable software module or processor-executable instructions, which may reside on a non-transitory computer-readable or processor-readable storage medium. Non-transitory computer-readable or processor-readable storage media may be any storage media that may be accessed by a computer or a processor. By way of example but not limitation, such non-transitory computer-readable or processor-readable storage media may include RAM, ROM, EEPROM, FLASH memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage smart objects, or any other medium that may be used to store desired program code in the form of instructions or data structures and that may be accessed by a computer. Disk and disc, as used herein, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk, and Blu-ray disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. Combinations of the above are also included within the scope of non-transitory computer-readable and processor-readable media. Additionally, the operations of a method or algorithm may reside as one or any combination or set of codes and/or instructions on a non-transitory processor-readable storage medium and/or computer-readable storage medium, which may be incorporated into a computer program product.” ([0056]).
Adler teaches selecting a 3D heart electrical conduction model from a database of representative 3D heart models based on patient demographic information, the selected 3D heart electrical conduction model including a 3D surface model with “In various embodiments, a cardiac imaging method may include recording electrocardiogram (ECG) data of a patient having an episodic cardiac condition using a portable ECG recorder for a time period sufficient for symptoms of the episodic cardiac condition to occur, providing patient data comprising the recorded ECG data to a processing unit, generating, by the processing unit, a three-dimensional (3D) activation map showing the propagation of electrical signals through the patient's heart based on the provided patient data, and displaying, by the processing unit, an ablation point on the 3D activation map, the ablation point being selected to alleviate the episodic cardiac condition. In some embodiments, the patient data provided to the processing unit may further include computed tomography (CT) or magnetic resonance imaging (MRI) data of the patient's heart and 3D image data of the patient's chest. In some embodiments, the time period may range from about 12 hours to about 48 hours. In some embodiments, the portable ECG recorder may include a 12-lead ECG recorder comprising 10 electrodes. In some embodiments, displaying the ablation point may include displaying multiple ablation points.” ([0010]); “In the example illustrated in FIG. 3A, the heart 1 is stimulated beginning at an earliest activation location 10. From the earliest activation location 10, the electrical signals will travel through the heart tissue. Hence, different parts of the heart will be activated at different times. Each location on the heart has a particular delay relative to the initial stimulation. Each node 8 has associated therewith a value representative of a time delay between stimulation of the heart 1 at the earliest activation location 10 and activation of the heart at that respective node 8. In the example illustrated in FIG. 3A, locations that share the same delay time are connected by isochrones 12. As used herein, isochrones are lines drawn on a 3D heart surface model connecting points on this model at which the activation occurs or arrives at the same time. The delay time for nodes across the heart surface in this example is also displayed by differing rendering shades. The vertical bar indicates the time delay in milliseconds associated with the respective shade. It will be appreciated that the stimulation location 10 can be the location of intrinsic activation of the heart 1.” ([0048]) and with “The 3D model 4 may also include further information. For example, the 3D model 4 may include cardiac blood vessels 14 and/or veins on the myocardium. This information may be added to the 3D model 4 in that nodes are indicated as being associated with such blood vessel. The blood vessels 14 may then be identified and optionally shown in the 3D model 4. Optionally, the processing unit 400 may include a first recognition unit arranged for automatically retrieving information representative of the location of such blood vessels from the patient's 3D anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0049]).
Adler teaches obtaining a 3D image of electrocardiographic (ECG) electrodes on a torso of the patient using a 3D camera with “FIG. 2A is a block diagram of a cardiac imaging system 200 according to various embodiments. Referring to FIG. 2A, the imaging system 200 may include a processing unit 400, a CT or MRI device 108, a 3D camera 109, and an ECG recorder 106. The cardiac imaging system 200 may also include a real-time imaging device 328 and a display 330. The CT/MRI device 108 may be configured to generate a 3D model of the chest and/or heart of the patient. The 3D camera 109 may be configured to generate a 3D image of the patient's torso. The ECG recorder 106 may be configured to record ECD data from the patient, which may include extrinsic and/or intrinsic stimulation signals.” ([0030]).
Adler teaches merging the 3D image of the patient's torso with the selected 3D heart electrical conduction model by aligning locations of ECG electrodes in the selected 3D heart electrical conduction model with corresponding ECG electrodes in the 3D image with “FIG. 2A is a block diagram of a cardiac imaging system 200 according to various embodiments. Referring to FIG. 2A, the imaging system 200 may include a processing unit 400, a CT or MRI device 108, a 3D camera 109, and an ECG recorder 106. The cardiac imaging system 200 may also include a real-time imaging device 328 and a display 330. The CT/MRI device 108 may be configured to generate a 3D model of the chest and/or heart of the patient. The 3D camera 109 may be configured to generate a 3D image of the patient's torso. The ECG recorder 106 may be configured to record ECD data from the patient, which may include extrinsic and/or intrinsic stimulation signals.” ([0030]) and with “In some embodiments, the method may optionally include additional operations 510, 512, and 514. In operation 510, the activation map may be used to guide the positioning of a cardiac catheter to an ablation location and/or to guide diagnostic electrodes to appropriate locations on the heart, in real time. The patient's heart may then be ablated at the ablation location in operation 510.” ([0044]).
Adler teaches generating a patient-specific 3D localization of an arrhythmia based on the selected 3D electrical conduction model and electrocardiographic (ECG) data; generating a patient-specific cardiac activation map based the 3D electrical conduction model and ECG data with “Various embodiments provide a cardiac imaging system and method that includes using a portable electrocardiogram (ECG) recorder to record ECG data of a patient having an episodic cardiac condition for a time period sufficient for symptoms of the episodic cardiac condition to occur. The recorded ECG data may be provided to a processing unit along with other patient data. The processing unit may generate a three-dimensional (3D) activation map showing the propagation of electrical signals through the patient's heart. Based on the provided patient data, the processing unit may display an ablation point on the 3D activation map, the ablation point being configured to alleviate the episodic cardiac condition.” (Abstract).
Adler teaches merging the patient-specific 3D localization of the arrhythmia and the 3D surface model to generate a 3D arrhythmia activation surface model with “The processing unit 400 may include an image integrator 326, which may be connected to a real-time imaging device 328, such as a fluoroscope, a radiography device, an X-ray computed tomography (CT) device, or the like. The image integrator 326 may compare and/or align the activation map and real-time images provided by the imaging device 328. Based on the comparison and/or alignment, the ablation point(s) may be added to the real-time images as virtual ablation point(s) to produce modified real-time images. The modified real-time images may be provided to and presented on a display 330.” ([0032]) and with “The 3D model 4 may also include information on scar tissue. Scar tissue locations may be obtained from delayed enhancement MRI images and added to the 3D model 4. Scar tissue may be simulated in the 3D model 4 by reducing the propagation velocity of electrical signals there through. Scar tissue may also be accounted for by selling the transition from one node to another to very slow or non-transitional for the areas in the heart wall where scar tissue is present. Optionally, the processing unit 400 may include a second recognition unit arranged for automatically retrieving information representative of the location of such scar tissue from the patient-specific three-dimensional anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0050]).
Adler teaches displaying the patient-specific 3D localization of the arrhythmia and the patient- specific cardiac activation map during a medical procedure that applies an ablation therapy to a localization point of the arrhythmia activation based on the patient- specific 3D localization of the arrhythmia and the patient-specific cardiac activation map with “In some embodiments, the activation map and images generated by the real-time imaging device 328 may be provided to the image integrator 326. The image integrator 326 may compare and/or align the activation map and the real-time images. Based on the comparison and/or alignment, the ablation point(s) may be added to the real-time images as virtual ablation point(s) to produce modified real-time images. The modified real-time images may be provided to and presented on the display 330 in operation 508.” ([0043]).
Regarding claim 12, Adler teaches wherein the patient demographic information includes one or more of the patient's gender, age, weight, height, body mass index, waist circumference, chest circumference, or underlying etiology with “Some heart defects in the conduction system result in asynchronous contraction (arrhythmia) of the heart and are sometimes referred to as conduction disorders. As a result, the heart does not pump enough blood, which may ultimately lead to heart failure. Conduction disorders can have a variety of causes, including age, heart (muscle) damage, medications and genetics.” ([0002]).
Regarding claim 14, Adler teaches wherein the processor is configured with processor-executable instructions to perform operations such that merging the patient-specific 3D localization of the arrhythmia and the 3D surface model to generate a 3D arrhythmia activation surface model comprises aligning locations of ECG electrodes used in generating patient-specific electrical conduction map of a patient's heart with the ECG electrodes within the 3D image with “FIG. 2A is a block diagram of a cardiac imaging system 200 according to various embodiments. Referring to FIG. 2A, the imaging system 200 may include a processing unit 400, a CT or MRI device 108, a 3D camera 109, and an ECG recorder 106. The cardiac imaging system 200 may also include a real-time imaging device 328 and a display 330. The CT/MRI device 108 may be configured to generate a 3D model of the chest and/or heart of the patient. The 3D camera 109 may be configured to generate a 3D image of the patient's torso. The ECG recorder 106 may be configured to record ECD data from the patient, which may include extrinsic and/or intrinsic stimulation signals.” ([0030]) and with “In some embodiments, the method may optionally include additional operations 510, 512, and 514. In operation 510, the activation map may be used to guide the positioning of a cardiac catheter to an ablation location and/or to guide diagnostic electrodes to appropriate locations on the heart, in real time. The patient's heart may then be ablated at the ablation location in operation 510.” ([0044]).
Regarding claim 16, Adler teaches wherein the arrhythmia is a ventricular arrhythmia with “In some embodiments, the episodic cardiac condition may include ventricular tachycardia (VT) or premature ventricular contraction (PVC). In some embodiments, displaying an ablation point may include displaying a location on the heart where the PVC occurs, or a location on the heart where the onset of the VT occurs.” ([0014])
Regarding claim 17, Adler teaches wherein the ventricular arrhythmia is a pre-ventricular contraction (PVC) with “Premature Ventricular Contractions (PVCs) are abnormal or aberrant heart beats that start somewhere in the heart ventricles rather than a normal sinus beat that starts from the upper chambers of the heart. PVCs typically result in a lower cardiac output heart beat because the ventricles contract before they have had the chance to completely fill with blood, which may be symptomatic. PVCs may also trigger Ventricular Tachycardia (VT or V-Tach).” ([0003])
Regarding claim 18, Adler teaches wherein the ventricular arrhythmia is a ventricular tachycardia with “Ventricular tachycardia (VT or V-Tach) is a heart arrhythmia disorder caused by abnormal electrical signals in the heart ventricles. In VT, the abnormal electrical signals cause the heart to beat faster than normal, usually more than 100 beats per minute, with the beats starting in the heart ventricles.” ([0004])
Regarding claim 19, Adler teaches wherein the processor is configured with processor-executable instructions to perform operations further comprising using the patent's demographic information and the patient-specific 3D heart model to create a new 3D heart model for inclusion in the database of representative 3D heart models with “The 3D model 4 may also include further information. For example, the 3D model 4 may include cardiac blood vessels 14 and/or veins on the myocardium. This information may be added to the 3D model 4 in that nodes are indicated as being associated with such blood vessel. The blood vessels 14 may then be identified and optionally shown in the 3D model 4. Optionally, the processing unit 400 may include a first recognition unit arranged for automatically retrieving information representative of the location of such blood vessels from the patient's 3D anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0049]) and with “The 3D model 4 may also include information on scar tissue. Scar tissue locations may be obtained from delayed enhancement MRI images and added to the 3D model 4. Scar tissue may be simulated in the 3D model 4 by reducing the propagation velocity of electrical signals there through. Scar tissue may also be accounted for by selling the transition from one node to another to very slow or non-transitional for the areas in the heart wall where scar tissue is present. Optionally, the processing unit 400 may include a second recognition unit arranged for automatically retrieving information representative of the location of such scar tissue from the patient-specific three-dimensional anatomical model of the heart. The processing unit 400 may then automatically insert this information into the 3D model 4.” ([0050]).
Regarding claim 20, Adler teaches wherein the processor is configured with processor-executable instructions to perform operations further comprising using the patent's demographic information and the patient-specific 3D heart model to adjusting a 3D heart model in the database of representative 3D heart models. with “In various embodiments, a cardiac imaging method may include recording electrocardiogram (ECG) data of a patient having an episodic cardiac condition using a portable ECG recorder for a time period sufficient for symptoms of the episodic cardiac condition to occur, providing patient data comprising the recorded ECG data to a processing unit, generating, by the processing unit, a three-dimensional (3D) activation map showing the propagation of electrical signals through the patient's heart based on the provided patient data, and displaying, by the processing unit, an ablation point on the 3D activation map, the ablation point being selected to alleviate the episodic cardiac condition. In some embodiments, the patient data provided to the processing unit may further include computed tomography (CT) or magnetic resonance imaging (MRI) data of the patient's heart and 3D image data of the patient's chest. In some embodiments, the time period may range from about 12 hours to about 48 hours. In some embodiments, the portable ECG recorder may include a 12-lead ECG recorder comprising 10 electrodes. In some embodiments, displaying the ablation point may include displaying multiple ablation points.” ([0010]).; “Some embodiments may further include ablating the heart at the displayed ablation location. Such embodiments may further include generating an updated 3D activation map of the heart after the ablating of the heart. Such embodiments may further include determining, based on the updated 3D activation map, whether a desired synchronization of the heart was achieved.” ([0015]) and with “In operation 512, an updated 3D activation map may be generated showing the results of the ablations performed in operation 510. For example, the updated activation map may be generated using ECG data collected after ablation is performed. Such ECG data may be collected during the procedure or afterwards, such as using a portable ECG recorder, such as a Holter-type ECG recorder, as in operation 500. The updated activation map may then be used to determine cardiac synchronicity” ([0045]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 3, 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Adler (US 2018/0303345 A1, Publication Date Oct. 25, 2018; Filed April. 18, 2018 as cited on the 06/10/2021 IDS Document) as applied to claims 1-2, 4, 6-12, 14 and 16-20 above, in view of Yang (US Patent Application 2019/0053728 A1, published Feb. 21, 2019; cited on the 11/30/2023 IDS Document).
Adler is applied to claims 1-2, 4, 6-12, 14 and 16-20 as discussed above.
Adler does not teach generating the patient-specific 3D localization of the arrhythmia comprises applying an inverse solution calculation to ECG data obtained with a 12-lead ECG system to identify a localization point of arrhythmia activation within a heartbeat of claim 3; wherein ECG data obtained with 12 ECG electrodes is combined with the patient specific 3D heart model using an inverse solution calculation to generate the localization point of the arrhythmia activation in the heartbeat of claim 5; wherein the processor is configured with processor-executable instructions to perform operations further comprising combining ECG data obtained with 12 ECG electrodes is combined with the patient specific 3D heart model using an inverse solution calculation to generate the localization point of the arrhythmia activation in the heartbeat of claim 15. However, these limitations are taught by Yang.
Regarding claim 3, Yang teaches generating the patient-specific 3D localization of the arrhythmia comprises applying an inverse solution calculation to ECG data obtained with a 12-lead ECG system to identify a localization point of arrhythmia activation within a heartbeat. Yang teaches ECG data obtained with 12 ECG electrodes with "Referring to FIG. 2, in one configuration, ARI values 210 may be extracted from unipolar electrograms. Unipolar electrograms may be included in CARTO files. Any appropriate electrogram recording device may be used for recording electrogram data, such as a quad mapping catheter. In one example, at each recording site, four unipolar electrograms (M1 to M4) may be recorded along with 12-lead ECGs by CARTO system. The ECG data may be used to identify the PVC beats 220. An electrogram signal and the first derivative of this signal may be plotted along with a selected lead from the ECGs to help identify PVC beats 220. The time length of CARTO recording may be 2.5 seconds in all the channels. The minimum derivative in QRS and the maximum derivative in T wave may be automatically detected by an appropriate algorithm and marked as activation time and recovery time respectively. Then, within the time segment of QRS complexes (or T wave), the minimum derivative (or maximum derivative) may be automatically determined. The time window of calculating the first derivative is within a certain number of samples dependent upon the sampling frequency, such as 20 samples with a sampling frequency of 1 kHz, which means the first derivative at time point i is the difference between the magnitude at time point i+10 and i−10." (Para. [0041])
Yang teaches ECG data is combined with a patient specific heart model using an inverse solution calculation to generate a localization point of the arrhythmia activation in a heartbeat with "After solving the inverse problem on QRS complexes and T waves separately, the time course of the equivalent current density at each source location may be obtained. By definition, the amplitude of equivalent current density is proportional to the spatial gradient of transmembrane potential. During the process of activation (or recovery), the spatial distribution of equivalent current density is dominated by its values at the interface between the activated and non-activated myocardium (or between the recovered and non-recovered myocardium). According to the peak criteria, the activation time τa (or recovery time τr) is when the amplitude of J(t) reaches its maximum during the duration time T at a fixed location P...." (Para. [0039])
Regarding claim 5, Yang teaches wherein ECG data obtained with 12 ECG electrodes with "Referring to FIG. 2, in one configuration, ARI values 210 may be extracted from unipolar electrograms. Unipolar electrograms may be included in CARTO files. Any appropriate electrogram recording device may be used for recording electrogram data, such as a quad mapping catheter. In one example, at each recording site, four unipolar electrograms (M1 to M4) may be recorded along with 12-lead ECGs by CARTO system. The ECG data may be used to identify the PVC beats 220. An electrogram signal and the first derivative of this signal may be plotted along with a selected lead from the ECGs to help identify PVC beats 220. The time length of CARTO recording may be 2.5 seconds in all the channels. The minimum derivative in QRS and the maximum derivative in T wave may be automatically detected by an appropriate algorithm and marked as activation time and recovery time respectively. Then, within the time segment of QRS complexes (or T wave), the minimum derivative (or maximum derivative) may be automatically determined. The time window of calculating the first derivative is within a certain number of samples dependent upon the sampling frequency, such as 20 samples with a sampling frequency of 1 kHz, which means the first derivative at time point i is the difference between the magnitude at time point i+10 and i−10." (Para. [0041])
Yang teaches ECG data is combined with a patient specific heart model using an inverse solution calculation to generate the localization point of the arrhythmia activation in the heartbeat with "After solving the inverse problem on QRS complexes and T waves separately, the time course of the equivalent current density at each source location may be obtained. By definition, the amplitude of equivalent current density is proportional to the spatial gradient of transmembrane potential. During the process of activation (or recovery), the spatial distribution of equivalent current density is dominated by its values at the interface between the activated and non-activated myocardium (or between the recovered and non-recovered myocardium). According to the peak criteria, the activation time τa (or recovery time τr) is when the amplitude of J(t) reaches its maximum during the duration time T at a fixed location P...." (Para. [0039]).
Regarding claim 15, Yang wherein the processor is configured with processor-executable instructions to perform operations further comprising combining ECG data obtained with 12 ECG electrodes with the patient specific3D heart model using an inverse solution calculation to generate the localization point of the arrhythmia activation in the heartbeat. Yang teaches ECG data obtained with 12 ECG electrodes with "Referring to FIG. 2, in one configuration, ARI values 210 may be extracted from unipolar electrograms. Unipolar electrograms may be included in CARTO files. Any appropriate electrogram recording device may be used for recording electrogram data, such as a quad mapping catheter. In one example, at each recording site, four unipolar electrograms (M1 to M4) may be recorded along with 12-lead ECGs by CARTO system. The ECG data may be used to identify the PVC beats 220. An electrogram signal and the first derivative of this signal may be plotted along with a selected lead from the ECGs to help identify PVC beats 220. The time length of CARTO recording may be 2.5 seconds in all the channels. The minimum derivative in QRS and the maximum derivative in T wave may be automatically detected by an appropriate algorithm and marked as activation time and recovery time respectively. Then, within the time segment of QRS complexes (or T wave), the minimum derivative (or maximum derivative) may be automatically determined. The time window of calculating the first derivative is within a certain number of samples dependent upon the sampling frequency, such as 20 samples with a sampling frequency of 1 kHz, which means the first derivative at time point i is the difference between the magnitude at time point i+10 and i−10." (Para. [0041])
Yang teaches ECG data is combined with a patient specific heart model using an inverse solution calculation to generate a localization point of the arrhythmia activation in a heartbeat with "After solving the inverse problem on QRS complexes and T waves separately, the time course of the equivalent current density at each source location may be obtained. By definition, the amplitude of equivalent current density is proportional to the spatial gradient of transmembrane potential. During the process of activation (or recovery), the spatial distribution of equivalent current density is dominated by its values at the interface between the activated