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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Response to Amendment
This action is in response to Applicant’s remarks, filed on 11/25/2025. The amendments to claim(s) 1 and 7 filed on 11/25/2025 have been entered. Claim(s) 2-3, 6, 11-12 and 17-18 is/are cancelled by Applicant and therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). Corresponding rejections of claim(s) 2-3, 6, 11-12 and 17-18 from prior office action are withdrawn as moot in light of the Applicant’s cancellation. Claim(s) 4-5, 10, 15-16 and 19-24 were withdrawn by Applicant from consideration. New claim(s) 25 have been entered. Accordingly, claim(s) 1, 7-9, 13-14 and 25 remain pending for examination on the merits (of which claims 1 and 25 are independent).
Response to Arguments
Applicant’s arguments, see p.8-12, filed 11/25/2025, with respect to the rejections of claim(s) 1, 7-9 and 13-14 have been fully considered.
After review of the amendments and remarks regarding the rejections to claim(s) 1, 7-9 and 13-14, Examiner respectfully disagrees with the Applicant. The 35 USC §112(b) rejections have been revised in view of the amended language and are maintained.
Applicant’s arguments with respect to claim(s) 1, 7-9, and 13-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner respectfully notes that Applicant' s arguments only address independent claim(s) 1, and no remarks regarding the subject matter of dependent claim(s) 7-9 and 13-14 have been presented. Rejections to the dependent claims are modified to address Applicant' s amendments and the new rejection to independent claim(s) 1 and are sustained. New claim 25 is rejected as discussed in the current office action. The rejections of claim(s) 1, 7-9, 13-14 and 25 under 35 U.S.C. §102 and 35 U.S.C. §103 are maintained.
Claim Objections
Claim(s) 1 recite(s) the limitation “such that […]”. It is suggested to replace the phrase “such that” with the term —wherein— to ensure the positive recitation of all elements in the claim. The use of the phrase “such that” may be interpreted as a negative limitation in the claim, resulting in an interpretation of subsequent limitations (i.e., “such that the displayed electro-anatomical data remain spatially registered with the anatomical structures depicted in the ultrasonic images; and” in claim 1) as preferred or suggested limitations, and therefore may be excluded from examination. Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 25 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 recites the limitations “a data interface configured to receive electro-anatomical data acquired from one or more electrodes disposed within the body region”, which is unsupported by the Applicant’s specification. The written description is devoid of any ‘data interface’, and there is no instance of a ‘data interface’ in the drawings.
35 USC § 112(b)
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.
Claim(s) 1, 7-9, 13-14 and 25 is/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. Dependent claim(s) 7-9 and 13-14 are also rejected at least by virtue of dependency upon a rejected base claim. Further, independent claim 1 and its dependent claims use specific terms and phrases inconsistently (noted below) and should be reviewed and amended to conform with standard U.S. practice.
Claim 1 recites the limitations “render to the display respective representations of electro-anatomical data obtained from a (3D) electro-anatomical map, the representations being superimposed on corresponding two- dimensional (2D) ultrasonic images wherein the 2D ultrasonic images represent slices through the 3D electro-anatomical map” which renders the claim indefinite. The claim language is unclear and there is insufficient antecedent basis for the limitations in the claim. The use of ‘corresponding two- dimensional (2D) ultrasonic images’ lacks antecedent basis because it is not certain if the ultrasonic images refer to those captured by the ‘ultrasound probe’ recited earlier in the claim or if they are new, distinct 2D ultrasonic images (e.g., ultrasonic images captured from a prior examination, reference ultrasonic images, etc.). Similarly, the source of the ‘electro-anatomical data’ and the ‘3D electro-anatomical map’ is unclear. First, it is not clear if either of the ‘3D electro-anatomical map’ – or the ‘electro-anatomical data’ obtained from the aforementioned ‘map’ – are generated from the ‘electrode of the mapping catheter’ recited earlier in the claim or if these data structures are new and distinct (e.g., an ‘electro-anatomical map’ captured from a prior examination, reference ‘electro-anatomical data/map’, etc.). It is suggested to amend the claim to clearly identify the source of both the ‘2D ultrasonic images’ and the ‘3D electro-anatomical map’. For the purposes of examination the broadest reasonable interpretations of the ‘2D ultrasonic images’ and the ‘3D electro-anatomical map’ – including those discussed above – may be any source for ultrasonic images and ‘electro-anatomical data.
Claim 7 recites the limitations “the processor is configured to render to the display a respective representation of an electro-anatomical data subset superimposed over one of the ultrasonic images including an internal structure of a chamber of a heart with the one of the respective representations indicating electro-anatomical data of the internal structure” which renders the claim indefinite, and the claim language is inconsistent. The ‘ultrasonic images’ and ‘respective representations indicating electro-anatomical data’ lack sufficient antecedent basis; the use of ‘ultrasonic images’ is unclear because the inconsistent language (e.g., 2D ultrasonic images vs. ultrasonic images) does not particularly point out what ‘ultrasonic images’ is referring to, and the ‘respective representations indicating electro-anatomical data’ may refer to the previously recited ‘respective representations’ in independent claim 1 or to new ‘respective representations’. For the purposes of examination, the broadest reasonable interpretation of the claim language is applied to the limitations.
Claim 14 recites the limitations “wherein each respective ultrasound image of the respective ones of the ultrasonic images is a respective two-dimensional (2D) slice”, which renders the claim indefinite. First there is insufficient antecedent basis for the ‘ultrasound image(s)’ because it is not clear what they are referring to, as independent claim 1 introduces two potential sets of ‘ultrasonic images’ in different limitations. Furthermore it is not clear what is being claimed with the phrase ‘a respective two-dimensional (2D) slice’, as the ‘render’ clause in claim 1 already defines 2D ultrasonic images as representative of “slices through the 3D electro-anatomical map” – the redundant language may be interpreted as the previously recited slices or new and distinct 2D slices. In view of the discussion regarding the 35 U.S.C. §112 rejection above, it is suggested to amend the claim to clarify what the “respective ones of the ultrasonic images” are referring to and what “a respective two-dimensional (2D) slice” means within the context of the claims. For the purposes of examination, the broadest reasonable interpretation of the claim language is applied to the limitations.
Claim 25 recites the limitations “a data interface configured to receive electro-anatomical data acquired from one or more electrodes disposed within the body region; and”, which renders the claim indefinite. It is not clear what the ‘data interface’ is. Upon review of the instant specification, Applicant’s disclosure is devoid of adequate description. For the purposes of examination the broadest reasonable interpretation of the ‘data interface’ is any type of generic computing or processing component capable of receiving electro-anatomical data.
Claim 25 further recites the limitations “render, on a display, a composite image comprising the ultrasonic image and one or more graphical representations” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim. In particular, it is not clear what the ‘ultrasonic image’ is referring to: in an interpretation the ‘ultrasonic image’ may refer to one of the plurality of ‘ultrasonic images’ acquired by the ‘position-tracked ultrasound probe’ recited earlier in the claim, or may refer to a new, singular ‘ultrasonic image’ from another source. For the purposes of examination the broadest reasonable interpretation – including those discussed above – is applied to the limitation.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7-8, 14 and 25 is/are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Altmann et al. (US20060241445A1, 2006-10-26; hereinafter “Altmann”).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Altmann teaches a medical system (“A system for modeling of an anatomical structure,” [clm 19]; [fig. 1-2, 6]), comprising:
a mapping catheter configured to be inserted into a body part of a living subject, the mapping catheter comprising at least one electrode configured to capture electrical activity from tissue of the body part at respective locations over time (“the anatomical structure comprises a heart and wherein the probe comprises a catheter” [clm 21]; “a system 20 for imaging and mapping a heart 24 of a patient” [0138]; “the distal end of the catheter also comprises at least one electrode 46 for performing diagnostic and/or therapeutic functions, such as electro-physiological mapping […] The electrical potentials measured by electrode 46 may be used in mapping the local electrical activity on the endocardial surface.” [0155]; “system 20 supports a measurement of local electrical potentials on the surfaces of the target structure. In this measurement, each electrical activity data-point acquired by catheter 28 comprises an electrical potential or activation time value measured by electrode 46” [0175]; The catheter comprises electrodes disposed at the distal end of the probe which acquire local electrical activity over time which are mapped to the endocardial surface [0150-0181], [fig. 1-3, 6; see fig. 2 reproduced below]);
an ultrasound probe configured to capture ultrasonic images of at least a portion of the body part when inserted into the body of the living subject (“a probe, comprising: an ultrasonic sensor, which is configured to acquire a plurality of ultrasonic images of the anatomical structure at a respective plurality of spatial positions of the probe;” [clm 19]; “The catheter comprises an ultrasonic imaging sensor. The ultrasonic sensor typically comprises an array of ultrasonic transducers 40.” [0150]; “After receiving the reflected ultrasound echoes, electric signals based on the reflected echoes are sent by transducers 40 over cables 33 through catheter 28 to an image processor 42 in console 34, which transforms them into 2-D, typically sector-shaped ultrasound images.” [0153]; [0150-0181], [fig. 1-2, 6; see fig. 2 reproduced below]):
at least one position sensor configured to generate at least one signal indicative of positions of the ultrasound probe and of the at least one electrode of the mapping catheter (“a probe, comprising: […] a position sensor, which is configured to determine location and orientation coordinates of the ultrasonic sensor at each of the plurality of spatial positions;” [clm 19]; “Position sensor 32 is typically located within the distal end of catheter 28, adjacent to electrode 46 and transducers 40. […] offsets are typically used by positioning processor 36 to derive the coordinates of the ultrasonic sensor and of electrode 46, given the measured position of position sensor 32.” [0157]; System utilizes position sensor and positioning sub-system to measure location and orientation coordinates of catheter within the cardiac anatomy, including the locations of electrodes and ultrasound transducer [0150-0181], [fig. 1-2, 6; see fig. 2 reproduced below]);
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Catheter probe 28 comprising electrodes 46, position sensor 32 and ultrasonic sensor/transducers 40 disposed at distal end of the catheter probe (Altmann [fig. 2])
a display (“an interactive display,” [clm 19]; [0150-0181], [fig. 1-2, 6]); and
a processor (“a processor,” [clm 19]; [0150-0181], [fig. 1-2, 6]) configured to:
determine, in real time, positions of the ultrasound probe and of the at least one electrode of the mapping catheter within a shared three-dimensional (3D) coordinate frame responsive to the at least one signal generated by the at least one position sensor (“a processor, which is coupled to receive the ultrasonic images and the measured location and orientation coordinates, to accept the manually-marked contours-of-interest and to construct a 3-D model of the anatomical structure” [clm 19]; “Image processor 42 typically computes or determines position and orientation information, displays real-time ultrasound images, performs 3-D image or volume reconstructions and other functions” [0153]; “the positioning sub-system measures and calculates the position of the catheter. […] Typically, each position of the catheter is represented in coordinate form, such as a six-dimensional coordinate” [0165]; “The image processor subsequently assigns 3-D coordinates to the contours-of-interest identified in the set of images, […] the location and orientation of the planes of these images in 3-D space are known by virtue of the positional information, stored together with the images” [0171]; The processor determines the position of the catheter probe (including ultrasound transducer, electrodes and the corresponding ultrasound and local electrical activation data acquired by each) at respective positions within a shared 3D coordinate system co-registered with the cardiac anatomy in real-time [0150-0181], [fig. 1-2, 6]);
render to the display respective representations of electro-anatomical data obtained from a (3D) electro-anatomical map, the representations being superimposed on corresponding two-dimensional (2D) ultrasonic images wherein the 2D ultrasonic images represent slices through the 3D electro-anatomical map (“the processor and the interactive display are coupled to overlay at least one of an electrical activity map and a parametric map on the surface model” [clm 31]; “Image processor 42 typically computes or determines position and orientation information, displays real-time ultrasound images, performs 3-D image or volume reconstructions and other functions” [0153]; “each electrical activity data-point acquired by catheter 28 comprises an electrical potential or activation time value measured by electrode 46 and the corresponding position coordinates of the catheter measured by the positioning sub-system for creation or generation of an electrophysiological map (by the image processor). The image processor registers the electrical activity-data-points with the coordinate system of the 3-D model and overlays them on the model, […] the data-points are typically superimposed on the 3-D model of the structure” [0175]; “The surface of the right ventricle is overlaid with an electrical activity map 90, as measured by electrode 46 […] The map presents different electrical potential values using different colors” [0193]; The processor utilizes 2D ultrasound images to a reconstruct 3D model of the target structure (e.g., cardiac anatomy) and register, overlay and display in real-time an electro-anatomical map on the 3D reconstructed model [0150-0181], [fig. 1-3, 6; see fig. 6, 8 reproduced below]);
dynamically update, in real time, the superimposed representations in response to position signals provided by the position sensor indicating movement of the ultrasound probe, such that the displayed electro-anatomical data remain spatially registered with the anatomical structures depicted in the ultrasonic images (“Image processor 42 typically computes or determines position and orientation information, displays real-time ultrasound images, performs 3-D image or volume reconstructions and other functions” [0153]; “each electrical activity data-point acquired by catheter 28 […] and the corresponding position coordinates of the catheter measured by the positioning sub-system for creation or generation of an electrophysiological map (by the image processor). The image processor registers the electrical activity-data-points with the coordinate system of the 3-D model and overlays them on the model” [0175]; “system 20 can be used as a real-time or near real-time imaging system. […] During the procedure, system 20 can continuously track and display the 3-D position of the catheter with respect to the model and the tagged contours” [0181]; The position of the catheter probe and 2D ultrasound image are continuously updated in real-time during the procedure based on the tracked position of the catheter probe relative to the cardiac anatomy [0150-0181], [fig. 1-3, 6, 8; see fig. 6, 8 reproduced below]); and
display, in the superimposed representations, color-encoded lines or regions corresponding to local activation time (LAT) data or bipolar data (“wherein the processor and the interactive display are coupled to overlay at least one of an electrical activity map and a parametric map on the surface model.” [clm 31]; “electrode 46 is used for sensing local electrical potentials. The electrical potentials measured by electrode 46 may be used in mapping the local electrical activity on the endocardial surface. When electrode 46 is brought into contact or proximity with a point on the inner surface of the heart, it measures the local electrical potential at that point.” [0155]; “The measured parameters, such as local electrical potentials, are optionally overlaid and displayed as an additional layer on the reconstructed 3-D model of the target structure” [0166]; “The electrical potential values may be presented using a color scale, […] the image processor may interpolate or extrapolate the measured electrical potential values and display a full color map that describes the potential distribution across the walls of the target structure” [0176]; [0150-0181], [fig. 1-3, 6, 8; see fig. 6, 8 reproduced below]).
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Display of local electrical potentials, 2D ultrasound image and cardiac anatomy (Altmann [fig. 6, 8])
Regarding claim 7, Altmann teaches the system according to claim 1,
Altmann further teaching wherein the processor is configured to render to the display a respective representation of an electro-anatomical data subset superimposed over one of the ultrasonic images including an internal structure of a chamber of a heart with the one of the respective representations indicating electro-anatomical data of the internal structure (“electrode 46 is used for sensing local electrical potentials. The electrical potentials measured by electrode 46 may be used in mapping the local electrical activity on the endocardial surface. When electrode 46 is brought into contact or proximity with a point on the inner surface of the heart, it measures the local electrical potential at that point.” [0155]; “The measured parameters, such as local electrical potentials, are optionally overlaid and displayed as an additional layer on the reconstructed 3-D model of the target structure” [0166]; “each electrical activity data-point acquired by catheter 28 comprises an electrical potential or activation time value measured by electrode 46 and the corresponding position coordinates of the catheter measured by the positioning sub-system for creation or generation of an electrophysiological map (by the image processor). The image processor registers the electrical activity-data-points with the coordinate system of the 3-D model and overlays them on the model, […] the data-points are typically superimposed on the 3-D model of the structure” [0175]; “The surface of the right ventricle is overlaid with an electrical activity map 90, as measured by electrode 46 […] The map presents different electrical potential values using different colors” [0193]; Local electrical potentials (i.e., electro-anatomical subsets) may be overlaid on a 3D model of the heart corresponding to the anatomical locations where they are acquired [0150-0181], [fig. 1-3, 6, 8], [see claim 1 rejection]).
Regarding claim 8, Altmann teaches the system according to claim 7,
Altmann further teaching wherein the internal structure is a papillary muscle (“wherein the anatomical structure comprises a heart” [clm 21]; “Although the embodiments described herein refer particularly to structures in and around the heart, the principles of the present invention may similarly be applied, mutatis mutandis, in imaging of bones, muscles and other organs and anatomical structures” [0163]; “In this 2-D ultrasound image, feature 80 represents the mitral valve and feature 82 represent the aortic valve.” [0184]; “a solid 3-D model of the right ventricle, generated by the image processor. Some of contours 88 are overlaid on the solid model. In addition, contours 89 showing the left ventricle can also be seen in the figure. The surface of the right ventricle is overlaid with an electrical activity map 90, as measured by electrode 46” [0193]; The anatomical structures of the heart which may be ultrasonically imaged and whose local electrical activity measured include muscles inside the heart including the ventricular surfaces and valves (i.e., the papillary muscles) [0150-0181], [fig. 1-3, 6, 8]).
Regarding claim 14, Altmann teaches the system according to claim 1,
Altmann further teaching wherein each respective ultrasound image of the respective ones of the ultrasonic images is a respective two-dimensional (2D) slice (“an ultrasonic sensor, which is configured to acquire a plurality of ultrasonic images of the anatomical structure at a respective plurality of spatial positions of the probe; ” [clm 19]; “Image processor 42 typically computes or determines position and orientation information, displays real-time ultrasound images, performs 3-D image or volume reconstructions and other functions” [0153]; “each electrical activity data-point acquired by catheter 28 comprises an electrical potential or activation time value measured by electrode 46 and the corresponding position coordinates of the catheter measured by the positioning sub-system for creation or generation of an electrophysiological map (by the image processor). The image processor registers the electrical activity-data-points with the coordinate system of the 3-D model and overlays them on the model, […] the data-points are typically superimposed on the 3-D model of the structure” [0175]; [0150-0181], [fig. 1-3, 6, 8], [see claim 1 rejection]).
Regarding claim 25, Altmann teaches a medical imaging system (“A system for modeling of an anatomical structure,” [clm 19]; [fig. 1-2, 6]) comprising:
a position-tracked ultrasound probe configured to capture ultrasonic images of an internal body region of a subject (“a probe, comprising: an ultrasonic sensor, which is configured to acquire a plurality of ultrasonic images of the anatomical structure at a respective plurality of spatial positions of the probe; and a position sensor, which is configured to determine location and orientation coordinates of the ultrasonic sensor at each of the plurality of spatial positions;” [clm 19]; “The catheter comprises an ultrasonic imaging sensor. The ultrasonic sensor typically comprises an array of ultrasonic transducers 40.” [0150]; [0150-0181], [fig. 1-2, 6], [see claim 1 rejection]);
a data interface configured to receive electro-anatomical data acquired from one or more electrodes disposed within the body region (“wherein the probe and the processor are coupled to synchronize a timing of acquisition of the ultrasonic images and measurement of the location and orientation coordinates relative to a synchronizing signal comprising one of an electrocardiogram (ECG) signal,” [clm 23]; “the distal end of the catheter also comprises at least one electrode 46 for performing diagnostic and/or therapeutic functions, such as electro-physiological mapping […] The electrical potentials measured by electrode 46 may be used in mapping the local electrical activity on the endocardial surface.” [0155]; “the positioning and image processors are implemented using a general-purpose computer, […] The positioning processor and image processor may be implemented using separate computers or using a single computer, or may be integrated with other computing functions of system 20.” [0162]; The general purpose computer may function as a data interface [0150-0181], [fig. 1-2, 6], [see claim 1 rejection]); and
a processor (“a processor,” [clm 19]; [0150-0181], [fig. 1-2, 6]) configured to:
determine, in real time, the spatial relationship between the ultrasound probe and the electro-anatomical data in a common three-dimensional coordinate frame (“a processor, which is coupled to receive the ultrasonic images and the measured location and orientation coordinates, to accept the manually-marked contours-of-interest and to construct a 3-D model of the anatomical structure” [clm 19]; “Image processor 42 typically computes or determines position and orientation information, displays real-time ultrasound images, performs 3-D image or volume reconstructions and other functions” [0153]; “the positioning sub-system measures and calculates the position of the catheter. […] Typically, each position of the catheter is represented in coordinate form, such as a six-dimensional coordinate” [0165]; “The image processor subsequently assigns 3-D coordinates to the contours-of-interest identified in the set of images, […] the location and orientation of the planes of these images in 3-D space are known by virtue of the positional information, stored together with the images” [0171]; [0150-0181], [fig. 1-2, 6], [see claim 1 rejection]);
render, on a display, a composite image comprising the ultrasonic image and one or more graphical representations of the electro-anatomical data that are automatically updated in real time responsive to movement of the ultrasound probe (“Image processor 42 typically computes or determines position and orientation information, displays real-time ultrasound images, performs 3-D image or volume reconstructions and other functions” [0153]; “each electrical activity data-point acquired by catheter 28 comprises an electrical potential or activation time value measured by electrode 46 and the corresponding position coordinates of the catheter measured by the positioning sub-system for creation or generation of an electrophysiological map (by the image processor). The image processor registers the electrical activity-data-points with the coordinate system of the 3-D model and overlays them on the model, […] the data-points are typically superimposed on the 3-D model of the structure” [0175]; “system 20 can be used as a real-time or near real-time imaging system. […] During the procedure, system 20 can continuously track and display the 3-D position of the catheter with respect to the model and the tagged contours” [0181]; “The surface of the right ventricle is overlaid with an electrical activity map 90, as measured by electrode 46 […] The map presents different electrical potential values using different colors” [0193]; [0150-0181], [fig. 1-3, 6, 8], [see claim 1 rejection]); and
encode the graphical representations using color or motion cues indicative of local activation time or bipolar signal amplitude data (“wherein the processor and the interactive display are coupled to overlay at least one of an electrical activity map and a parametric map on the surface model.” [clm 31]; “electrode 46 is used for sensing local electrical potentials. The electrical potentials measured by electrode 46 may be used in mapping the local electrical activity on the endocardial surface. When electrode 46 is brought into contact or proximity with a point on the inner surface of the heart, it measures the local electrical potential at that point.” [0155]; “The measured parameters, such as local electrical potentials, are optionally overlaid and displayed as an additional layer on the reconstructed 3-D model of the target structure” [0166]; “The electrical potential values may be presented using a color scale, […] the image processor may interpolate or extrapolate the measured electrical potential values and display a full color map that describes the potential distribution across the walls of the target structure” [0176]; [0150-0181], [fig. 1-3, 6, 8], [see claim 1 rejection]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altmann as applied to claims 1 and 8 above, in view of Chou et al. (US2021/0169394 A1; 2021-06-10, hereinafter “Chou”).
Regarding claim 9, Altmann teaches the system according to claim 8,
but Altmann may fail to explicitly teach bipolar data.
However, in the same field of endeavor, Chou teaches a medical system (“A cardiac information processing system, comprising: multiple subsystems for performing a procedure and producing procedure data” [clm 1]; [fig. 1-3]);
Chou further teaching wherein the electro-anatomical data of the internal structure includes bipolar data (“Mapping subsystem 100 can comprise an electrical mapping system configured to produce mapping data 110 corresponding to: […] activation timing data (e.g. unipolar and/or bipolar activation timing data calculated from recorded electrocardiograms); and combinations of these.” [0069]; “data processing algorithm 551 is configured to determine a quantitative value and/or assess a qualitative state of a parameter of a portion of tissue, Assessed tissue parameters can include parameters selected from the group consisting of: electrical; mechanical; physiological; electrophysiological; histological; functional; dynamic; thermodynamic; chemical; biochemical; and combinations of these.” [0091]; “Calculated electrical activity data 2120 b can comprise data that represents instances of electrical activation […] calculated electrical activity data 2120 b comprises data that represents, conduction velocity, conduction velocity data 122, and/or conduction divergence, conduction divergence data 123. Calculated electrical activity data 2120 b can be correlated to one or more locations of the heart,” [0103]; [0059-0081, 0098-0145, 0177-0195], [fig. 1-2]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the instant application to combine the medical system taught by Altmann with the cardiac information processing system taught by Chou wherein the electro-anatomical data of the internal structure includes bipolar data. There is a general need for systems that process cardiac information to achieve improved outcomes in patients with one or more cardiac conditions (Chou [0022]). Real-time imaging improves physician performance and enables even relatively inexperienced physicians to perform complex surgical procedures more easily. 3-D imaging also helps to reduce the time needed to perform some surgical procedures (Altmann [0025]). Using the combined system complexity assessments based on electrical activity data can be provided in real time, such as during a treatment (e.g. ablation) to dynamically determine when the treatment has achieved a desired result (e.g. sufficient energy has been delivered to cause the desired effect, such as electrical block), and/or how to modify the therapy to achieve a therapeutic goal or otherwise improve efficiency (Chou [0162]).
Regarding claim 13, Altmann teaches the system according to claim 1,
Altmann further teaching wherein the at least one position sensor comprises: at least one first magnetic position sensor disposed on the mapping catheter; and at least one second magnetic position sensor (“the positioning sub-system comprises a magnetic position tracking system that determines the position and orientation of catheter 28” [0140]; “Position sensor 32 typically comprises three non-concentric coils […] Alternatively, any other suitable position sensor arrangement can be used, such as sensors comprising any number of concentric or non-concentric coils, Hall-effect sensors and/or magneto-resistive sensors.” [0158]; [0150-0181], [fig. 1-3, 6, 8], [see claim 1 rejection]);
but Altmann may fail to explicitly teach at least one second magnetic position sensor disposed on the ultrasound probe.
However, in the same field of endeavor, Chou teaches wherein the at least one position sensor comprises: at least one first magnetic position sensor disposed on the mapping catheter (“Sensor 900 can comprise one or more sensors selected from the group consisting of: an electrode or other sensor for recording electrical activity; […] a magnetic sensor;” [0076]; “Mapping subsystem 100 can produce mapping data 110 comprising recorded cardiac activity data and/or device position data (e.g. data representing the 3D position of mapping catheter 10” [0079]; “a device of system 1000 (e.g. mapping catheter 10) can comprise a “multi-modal” device, for example a device including electrodes and ultrasound transducers that can be localized using impedance and ultrasonic methods.” [0081]; “LOC module 150 and LOC module 370 of mapping subsystem 100 and therapy subsystem 300, respectively, […] can each comprise modalities selected from the group consisting of: impedance-based localization; magnetic-based localization; any modality for localizing components in or around a body or body chamber; and combinations of these. LOC modules 150, 370 can each utilize transmitted, emitted and/or reflected energy modalities, such as ultrasound, RF, and/or fluoroscopy.” [0080]; The spatial position and orientation of the mapping catheter and electrodes is calculated by LOC module(s) of the subsystems using a magnetic sensor [0059-0081, 0098-0145, 0177-0195], [fig. 1-2]); and
at least one second magnetic position sensor disposed on the ultrasound probe (“LOC modules 150, 370 can each comprise modalities selected from the group consisting of: impedance-based localization; magnetic-based localization; any modality for localizing components in or around a body or body chamber; and combinations of these.” [0080]; The LOC modules may use the same method of localization (e.g., magnetic-based localization) for different subsystems (e.g., mapping catheter, therapy device, etc.) [0059-0081, 0098-0145, 0177-0195], [fig. 1-2]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the instant application to combine the medical system taught by Altmann with the cardiac information processing system taught by Chou with at least one second magnetic position sensor disposed on the ultrasound probe. There is a general need for systems that process cardiac information to achieve improved outcomes in patients with one or more cardiac conditions (Chou [0022]). Real-time imaging improves physician performance and enables even relatively inexperienced physicians to perform complex surgical procedures more easily. 3-D imaging also helps to reduce the time needed to perform some surgical procedures (Altmann [0025]). Furthermore, it is known that when the location of the surgical instrument relative to its immediate surroundings is displayed it may improve a physician's ability to precisely position the surgical instrument (Altmann [0018]).
Conclusion
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797