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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2024 and 10/30/2024 have been considered by the examiner.
Claim Objections
Claim 21 is objected to because of the following informalities:
In claim 21, line 3, “best fit a model” should read “best fit model”.
In claim 45, line 2, “SED” should read “single equivalent dipole”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations found in claim 1 are the following:
data collection system
data processing system
display system
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 25 and 36 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.
Claim 25 recites the limitation "probability distribution”. There is insufficient antecedent basis for this limitation in the claim. The specification does not disclose how the probability distribution is calculated.
The terms “low resolution” and “high resolution” in claim 36 are relative terms which renders the claim indefinite. The terms “low resolution” and “high resolution” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification fails to disclose a value for what is considered as “low resolution” and “high resolution”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 22 and 31 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 introduces a new element, “an emitting device”, which is not properly recited in claim 1.
Claim 31 fails to further limit claim 1. Claim 31 appears to further limit the "location of the cardiac conduction pathway" of claim 1. However, the "location of the cardiac conduction pathway" is not positively recited in claim 31.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carbonera et al., (US 20130138404), hereinafter Carbonera.
Regarding claim 1, Carbonera teaches a system for mapping (Fig. 1, element 10, para. 0029 (system), 0032 (mapping system), para. 0029 (generation of surface models including anatomic structures)) at least a portion of a cardiac conduction pathway in a patient (para. 0002 (heart or a particular portion thereof), 0035 (cardiac mapping)) the system comprising:
a plurality of sensors (Fig. 1, element 32, para. 0031 (sensors));
a data collection system for collecting sensor data from the plurality of sensors (para. 0008 (a catheter used to collect the plurality of location data points));
a data processing system (Fig. 1, element 16, para. 0036 (processing apparatus)) for calculating a center of electrical activity (CEA) data from the sensor data (para. 0036 (acquires location data points collected by the sensors), 0056 (data points collected by a sensor correspond to the center of the electrical activity of the sensor), 0045 (dipoles set in a coordinate system... dipoles may be used to perform the position sensing function and to collect the location data points));
and a display system (Fig. 1, element 44, para. 0048 (display device)) for presenting a three-dimensional (3D) model of a portion of the cardiac conduction pathway based on the calculated CEA data (para. 0047 (3d surface model)).
Regarding claim 5, Carbonera teaches the system of claim 1, wherein the display system (Fig. 1, element 44, para. 0048 (display device)) displays the portion of the cardiac conduction pathway located between an atrioventricular (AV) node and Purkinje fibers of a heart (para. 0002 (heart or a particular portion thereof)).
Regarding claim 49, Carbonera teaches the system of claim 1, further comprising an emitting device (Fig. 1, element 12, para. 0031 (catheter)), wherein the data processing system is configured to determine a location of the emitting device relative to the location of a portion of the cardiac conduction pathway (para. 0036 (location data collected by the catheter, 0042 (electrodes generate electrical signals used in determining the position and orientation of the catheter; x,y, and z axis)).
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.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Carbonera and in view of Armoundas et al. (US 6370412), hereinafter Armoundas.
Regarding claim 4, Carbonera teaches the system of claim 1, wherein the plurality of sensors (Fig. 1, element 32, para. 0031 (sensors)) detect a signal propagating through segments of the cardiac conduction pathway (para. 0043 (sensors are placed within electric fields created within the heart)).
Carbonera does not explicitly disclose detecting a signal during a PR segment of a cardiac cycle.
Armoundas teaches wherein the plurality of sensors detect a signal propagating through segments of the cardiac conduction pathway (col. 8, lines 42-43 (electrodes are used to acquire ECG potentials from the body)) during a PR segment of a cardiac cycle (col. 8, lines 52-53 (each beat is adjusted relative to an identified PR segment).
Carbonera and Armoundas are considered to be analogous to the clamed invention because they are in the same field of mapping and detecting electrical signals originating from the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carbonera to incorporate the teachings of Armoundas and provide a specific segment of the cardiac cycle for the sensors to collect information. Doing so would allow sensors to acquire data points from the same segment within the cardiac cycle to improve location accuracy.
Claims 6 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Carbonera and in view of Wang et al. (US 20190304186), hereinafter Wang.
Regarding claim 6, Carbonera teaches wherein the system of claim 1, wherein the data collecting system comprises a digital converter for generating high resolution data from very low voltage signals sensed by the plurality of sensors (para. 0042 (voltage levels are converted and provided to processing apparatus)).
Carbonera does not explicitly disclose resolution data from voltage signals.
Wang discloses a digital converter for generating high resolution data (para. 0032 (electrical activity can be displayed at a desired resolution) from very low voltage signals sensed by the plurality of sensors (para. 0067 (control system can set the parameters of the signals supplied to the device (e.g. voltage)).
Carbonera and Wang are considered to be analogous to the clamed invention because they are in the same field of computing electrical activity based on a portion of the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carbonera to incorporate the teachings of Wang and provide a resolution based on the data acquired. Doing so would allow the location data points to be in high resolution to ensure a more clear and detailed view of the cardiac mapping. Additionally, Wang provides a control system that allows for controlling the voltage from signals, thereby allowing very low voltage signals to be processed.
Regarding claim 31, Carbonera teaches wherein the system of claim 1, a location of the portion of the conduction pathway (para. 0002 (heart or a particular portion thereof)).
Carbonera does not teach wherein a location is determined before and after a therapy is applied to the patient.
Wang teaches a system (Fig. 1, element 100, para. 0021 (system)) wherein a location of the portion of the cardiac conduction pathway (para. 0019 (conduction pathway)) is determined before and after a therapy is applied to the patient (para. 0068 (before, during and/or after delivering a therapy via the system)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carbonera to incorporate the teachings of Wang and provide a location of the portion of the cardiac conduction system before and after a therapy is applied. Doing so would allow the physician to moderate the location to ensure accuracy on whether the electrical activity moved during different treatment periods.
Claims 21-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Carbonera and in view of Saksena et al. (US 20070232949), hereinafter Saksena.
Regarding claim 21, Carbonera teaches the system of claim 1, and a location of a portion of the cardiac conduction pathway (para. 0002 (heart or a particular portion thereof))
Carbonera does not teach wherein the location is determined by combining the center of electrical activity data from multiple cardiac cycles into a best fit a model.
Saksena teaches wherein a location of a portion of the cardiac conduction pathway is determined by combining the center of electrical activity data (para. 0037 (centers of irregular electrical activity (rotors))) from multiple cardiac cycles (para. 0044 (cycle; beginning to the end of fibrillation)) into a best fit a model (para. 0050 (additional analyses of measured electrical activity may be performed, such as combining to calculate a figure of merit)).
Carbonera and Saksena are considered to be analogous to the clamed invention because they are in the same field of mapping electrical activity within the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carbonera to incorporate the teachings of Saksena and provide a best fit model. Carbonera teaches a point cloud that is formed from acquiring location data points (para. 0044) and the processing apparatus is able to perform post-operating operations by adding additional location data points to the point cloud (para. 0052). This updates the “surface model by computing the combination of the original data points and the added data points” (para. 0052). Therefore, adding the teaching of Saksena to form a best fit model based on the electrical activity based on the cardiac cycles, improves location accuracy.
Regarding claim 22, Carbonera (in view of Saksena) teaches the system of claim 21, wherein the system is further configured to determine a location of a septum of a patient’s heart using data collected from an emitting device (para. 0044 (as the catheter is swept along a surface of interest, the processing apparatus received signals (location information) from the sensor… processing apparatus records location data point and therefore, a point on the surface of the desired structure being modeled)).
Regarding claim 24, Carbonera (in view of Saksena) teaches the system of claim 22, wherein the system is used for navigating a catheter (Fig. 1, element 12, para. 0031 (catheter, navigation)) to a target on the septum (para. 0035 (catheter is moved along a surface of a desired structure of the heart)).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Saksena and in view of Carbonera.
Regarding claim 23, Saksena (in view of Carbonera) teaches the system of claim 22, wherein the location of the septum (para. 0028 (mapping septum)) constrains the best fit model of the cardiac conduction pathway (para. 0032 (electrical activity received by each electrode can be related to the corresponding location in the heart), 0050 (various types and locations of data may be combined to calculate a figure of merit that is useful for diagnostic and therapy planning purposes)).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Carbonera and in view of Saksena and further in view of Narayan et al., (US 20130006131), hereinafter Narayan.
Regarding claim 25, Carbonera (in view of Saksena) teaches the system of claim 22.
Carbonera (in view of Saksena) does not teach wherein a probability distribution for the location of the cardiac conduction pathway is graphically displayed on an image of the septum.
Narayan teaches a system (abstract) wherein a probability distribution (para. 0123 (data collected from sensors may take the form of a probability distribution map) for location of the cardiac conduction pathway (para. 0096 (rotational pattern around a core region indicative of a rotor) is graphically displayed (para. 0124 (visual display screen)) on an image of the septum.
Carbonera, Saksena, and Narayan are all considered to be analogous to the clamed invention because they are in the same field of mapping electrical activity within the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carbonera (in view of Saksena) to incorporate the teachings of Narayan and provide a probability distribution for the location of the cardiac conduction pathway. Doing so would have predictably resulted in an improved and more informative representation for displaying the location of electrical activity within the cardiac conduction pathway.
Claims 36, 40-41, and 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and in view of Armoundas.
Regarding claim 36, Wang teaches a method (para. 0004 (method)) of mapping at least a portion of a cardiac conduction pathway (para. 0004 (cardiac envelope), para. 0019 (conduction pathway is included in cardiac envelope)) comprising:
sensing, via sensors (Fig. 6, element 614, para. 0068 (sensor array includes one or more sensors)), signals indicative of cardiac electrical signals propagating through the cardiac conduction pathway (para. 0065 (electrical signal can be measured by a plurality of sensors));
combining the signals from each sensor (Fig. 2, element 214, para. 0042 (combinatorial function)), via a data collection system, (Fig. 6, element 610, para. 0065 (control processes measured signals)) to generate a first data stream (para. 0065 (measurement data));
identifying, via a data processing system (Fig. 1, element 104, para. 0033 (processor)), a waveform (para. 0065 (apply an electrical signal e.g., a waveform that can be measured by sensors)) from the data stream via a low resolution sampling of the first data stream (para. 0071 (data acquisition process (e.g., sample rate, line filtering), 0072 (set a resolution), 0053 (high spatial resolution));
sampling, via the data processing system, a segment of the identified waveform of the first data stream at a high-resolution to generate a second data stream (para. 0071 (data acquisition process (e.g., sample rate, line filtering), 0072 (set a resolution), 0053 (high spatial resolution));
determining, via the data processing system, center of electrical activity (CEA) data based on the second data stream (Fig. 2, para. 0018 (computations determines electrical activity; within the processor), 0057 (spatial distribution of electrode locations where the electrical activity is measured));
and generating, via a display system (Fig. 6, element 642, para. 0076 (output data can be rendered as a corresponding graphical map in a display such as electrical activities of patient anatomy)), a three-dimensional (3D) model of the CEA data in real time (para. 0022 (electrical data may include real time measurements of the electrical activity)).
Wang does not disclose identified sampling a segment of the identified waveform and a 3D model indicative of the cardiac conduction pathway.
Armoundas teaches a method (col. 4, line 15 (method)) of mapping at least a portion of a cardiac conduction pathway (col. 4, line 21 (heart)) comprising:
identifying, via a data processing system (col. 8, lines 42-43 (electrodes are used to acquire ECG potentials from the body)), a waveform (col. 8, lines 51-52 (QRS complex is identified in each ECG beat)) from the data stream via a low resolution sampling of the first data stream;
sampling, via the data processing system, a segment of the identified waveform (col. 8, lines 52-53 (each beat is adjusted relative to an identified PR segment)) of the first data stream at a high-resolution to generate a second data stream;
determining, via the data processing system, center of electrical activity (CEA) data based on the second data stream (col. 9, lines 12-14 (an algorithm to fit the SEMD parameters to the ECG potentials is applied for every time epoch in the cardiac cycle));
and generating, via a display system, a three-dimensional (3D) model of the CEA data in real time, wherein the 3D model is indicative of the cardiac conduction pathway (col. 11, lines 3-4 (cardiac electrical activity at each time epoch are displayed in a three-dimensional view of the heart)).
Wang and Armoundas are considered to be analogous to the clamed invention because they are in the same field of computing electrical activity based on a portion of the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to incorporate the teachings of Armoundas and provide sampling of an identified waveform. Doing so would allow for retrieving electrical activity from specific parts of the waveform, that specifically correlate with a fibrillation. Targeting this improves the accuracy of locating the center of the electrical activity. Additionally, although Wang teaches a display system that can display a graphical map, it does not explicitly disclose that the map is three-dimensional. Therefore, adding the display system from the teachings of Armoundas, would provide the three-dimensional view of the heart, which will allow the physicians to view the center of the electrical activity within the cardiac conduction system, more clearly than a 2D image.
Regarding claim 40, Wang (in view of Armoundas) teaches the method of claim 36.
Wang does not disclose wherein the segment of the identified waveform is a PR segment of the identified waveform.
However, Armoundas teaches wherein the segment of the identified waveform is a PR segment of the identified waveform (col. 8, line 52-53 (each beat is adjusted relative to an identified PR segment)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to incorporate the teachings of Armoundas and provide a PR segment of the identified waveform. Wang teaches a waveform that can be measured by sensors, but does not explicitly disclose identifying the PR segment of the waveform (para. 0065). Therefore, incorporating the identified PR segment disclosed by Armoundas would allow for identifying the specific activity within the waveform during fibrillation.
Regarding claim 41, Wang (in view of Armoundas) teaches the method of claim 36, further comprising determining locations of the sensors with respect to a heart of a subject by scanning the subject and the sensors, wherein the sensors are disposed on a body of the subject (para. 0025 (a location for each of the electrodes in the sensor array can be included in the geometry data, such as by acquiring the image while the electrodes are disposed on the patient, and identifying the electrode locations)).
Regarding claim 43, Wang (in view of Armoundas) teaches the method of claim 41, wherein determining CEA data is further based on the determined locations of the sensors (0067 (sensor can communicate sensor information back to the control), 0065 (control processes and control the capture of the measured signals), para. 0022 (memory stores electrical data such as representing electrical signals measured from the body surface over one or more time intervals)).
Regarding claim 44, Wang (in view of Armoundas) teaches the method of claim 36, further comprising sensing, via the sensors (Fig. 6, element 614, para. 0068 (sensor array includes one or more sensors)), a single dipole signal from an emitting device disposed within a heart of a subject (para. 0064 (localization engine can operate to localize the catheter employing an equivalent dipole model and measurements)).
Regarding Claim 45, Wang (in view of Armoundas) teaches the method of claim 44, further comprising determining, via the processing system, a location and orientation of the emitting device (para. 0064 (localization engine can provide coordinates for the catheter)) using SED analysis (para. 0064 (localization engine can operate to localize the catheter employing an equivalent dipole model and measurements)).
Regarding Claim 46, Wang (in view of Armoundas) teaches the method of claim 45, further comprising generating, via the display system, a 3D representation of the emitting device with respect to the 3D model indicative of the cardiac conduction pathway, wherein the 3D representation indicates a location and orientation of the emitting device in real time (para. 0022 (real time analysis), 0064 (localization engine can provide coordinates for the catheter), 0065 (three-dimensional coordinate system)).
Regarding Claim 47, Wang (in view of Armoundas) teaches the method of claim 46, further comprising navigating the emitting device so that it is proximate to a desired portion of the cardiac conduction pathway based on the 3D representation (para. 0064 (device (catheter) can be guided via a localization engine), 0064 (localization engine can provide coordinates for the catheter), 0065 (three-dimensional coordinate system)).
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, the primary reason for indication of allowable subject matter is that the prior art fails to teach voltage signals below 0.1 mV.
The closest prior art Wang, provides a control system that allows for controlling the voltage from signals, thereby allowing very low voltage signals to be processed. However, Wang does not explicitly disclose the value of the voltage range.
Conclusion
The prior art made of record and not relied on is considered pertinent to applicant’s disclosure. Chou et al., (US 20240206797) is another example of cardiac mapping that provides cardiac activity data associated with cardiac chambers. Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 7:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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