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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on July 29, 2026, has been entered.
Response to Arguments
Applicant’s arguments, see Remark page 3, filed July 29, 2026, with respect to claims 26-29 have been reversed by Board Decision. Therefore, the U.S.C 103 rejection of claims 26-29 has been withdrawn. Claims 1-25 and 30-37 have been canceled. The Double Patenting of claims 26-29 has been maintained, since Applicant has not been amended/filed Terminal Disclaimer. Also, upon further consideration, new grounds of rejections are made in view of newly applied prior arts.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. US 11941754 in view of Mihailescu (US 20160135762 A1).
Table below illustrates example of claim 26 of the present Application compared against claims 9 of U.S Patent No. 11941754.
Present Application
US. Patent No. 11941754
Claim 26,
A method of generating a three-dimensional geometric model of a heart, the method comprising:
Claim 9,
A method of generating a three-dimensional geometric model of a heart, the method comprising:
receiving a plurality of two-dimensional image slices of the heart from an intracardiac echocardiography ("ICE") catheter, wherein each image slice of the plurality of image slices is associated with localization information of the ICE catheter;
receiving a plurality of two-dimensional image slices of the heart from an intracardiac echocardiography (“ICE”) catheter, wherein each image slice of the plurality of image slices is associated with localization information of the ICE catheter;
graphically outputting the plurality of two-dimensional image slices in a plurality of voxels according to the associated localization information of the ICE catheter, thereby creating a three-dimensional geometric model of the heart; and
graphically outputting the plurality of two-dimensional image slices in a plurality of voxels according to the associated localization information of the ICE catheter, thereby creating a three-dimensional geometric model of the heart;
graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies.
graphically representing data sufficiency of the three-dimensional geometric model of the heart, wherein graphically representing data sufficiency of the three-dimensional geometric model of the heart comprises one or more of: representing data sufficiency of the three-dimensional geometric model of the heart using a one-dimensional illustration of data sufficiency relative to angular rotation of the ICE catheter; and representing data sufficiency of the three-dimensional geometric model of the heart using a two-dimensional illustration of data sufficiency relative to localization of the ICE catheter.
Although the claims at issued are not identical, they are patentably distinct for each other because:
Comparing of the table above shows the claim 9 of Patent No. US 11941754 discloses claim 26 of present Application, but does not explicitly disclose graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies. However,
Mihailescu discloses:
graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies (Mihailescu, see pars. [0089-0090]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of claimed invention, to modify the method and apparatus of Claim 9 of U.S Patent No. 11941754, and have graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies, as taught by Mihailescu. The modification provides an improved system and method for generating a three-dimensional geometric model of medical image and improve quality of the image data, thereby to improve scanning quality and reduce errors by better defining the precise location of a detected signal. (Mihailescu, see par. [0007]).
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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over in view of Hill et al. (US 20120169712 A1) in view of Barbagli et al. (US 20120035481 A1) and further in view of Mihailescu et al. (US 20160135762 A1).
Regarding claim 26. Hill discloses a method of generating a three-dimensional geometric model of a heart, the method comprising:
receiving a plurality of two-dimensional image slices of the heart from an intracardiac echocardiography ("ICE") catheter, wherein each image slice of the plurality of image slices is associated with localization information of the ICE catheter (Hill, see at least par [0017] Device 12 is provided for the diagnosis and/or treatment of tissues within body 14 such as cardiac tissue. In the illustrated embodiment, device 12 comprises an intracardiac echocardiography (ICE) catheter. It should be understood, however, that the system and method as described herein could be used with other medical devices including, but not limited to, electrophysiological (EP) mapping catheters and ablation catheters. Device 12 includes one or more position sensors 24 mounted thereon that are configured to generate an induced current or voltage based on the location of sensors within a electric or magnetic field generated by system 18. Sensors 24 may comprise electrodes or coils, for example. Referring to FIG. 4 an exemplary ICE catheter 56 is shown. Catheter 56 include a conventional transducer array 58 and a plurality of electrodes 60, 62, 64, 66 acting as the position sensors 24. The position and orientation of array 58 is controlled in a conventional manner (e.g., through a physician activated or a motor driven shaft 68) and array 58 provides ultrasound data (i.e. two dimensional slice image data) to ECU 20 through conductors 70 connected to array 58. In the embodiment shown in FIG. 4, three electrodes 60, 62, 64 are equally spaced circumferentially about catheter 56 and, together with electrode 66 provide position and orientation data to ECU 20 such that the position and orientation of catheter 56--and the image data provided by array 58--can be determined in six degrees of freedom);
Hill does not disclose graphically outputting the plurality of two-dimensional image slices in a plurality of voxels according to the associated localization information of the ICE catheter, thereby creating a three-dimensional geometric model of the heart; and graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies. However,
Barbagli discloses:
graphically outputting the plurality of two-dimensional image slices in a plurality of voxels according to the associated localization information of the ICE catheter, thereby creating a three-dimensional geometric model of heart (Barbagli, see at least par. [0043] FIG. 4A illustrates that two catheters have been advanced into the right atrium of the heart of a patient. For example, one of the two catheters may be an intracardiac echocardiographic (ICE) catheter assembly (402) that may include one or more ultrasound transducers (502) (e.g., linear array ultrasound transducers, phased array ultrasound transducers, etc.) capable of producing two dimensional intracardiac echocardiograms. The ICE catheter (402) may be capable of producing two dimensional intracardiac echocardiograms of the heart (1102).).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of claimed invention, to modify the method and apparatus of Hill, and have graphically outputting the plurality of two-dimensional image slices in a plurality of voxels according to the associated localization information of the ICE catheter, thereby creating a three-dimensional geometric model of the heart, as taught by Barbagli. The modification provides an improved system and method for generating a three-dimensional geometric model of medical image and improve quality of the image data, thereby to advance the art of minimally invasive surgery, there is a need to overcome the limitations of access to internal tissues and organs; in particular, the limitation of visual access to the tissues and organs that are being diagnosed and treated. (Barbagli, see par. [0003]).
Hill in view of Barbagli does not disclose graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies. However,
Mihailescu discloses:
graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies (Mihailescu, see pars. [0089] In order to intuitively present to the operator the distribution of voxels that have been sufficiently scanned, or insufficiently, over the scanning period, a rendering of the image representing one or more versions of SCV can be performed and displayed. In some embodiments, the rendering of the SCV map can be overlapped onto the visual streaming image taken by the tracking camera or other camera whose position and orientation is known in respect to the patient. In such embodiments, the pixel intensity from a selected area in the video stream can be modified to indicate skin transparency. The rendering of the SCV map may, for example, be performed so that, voxels with incomplete scanning show transparent, and voxels with sufficient scanning show more opaque and/or with a higher intensity color. Various volumetric rendering or maximum intensity projection methods can be used for the visualization of the SCV map. Alternatively, the rendering of the SCV map may be performed so that, voxels with incomplete scanning show opaque, and voxels with sufficient scanning show more transparent. An advantage of this second visualization approach is that the voxels that become transparent can leave a clear line of sight to visualize a rendering of the 3-D sensor created map that may form in the areas being scanned. The resulting visual effect will be that, as the sensor scans a certain volume, that volume will become transparent (or eroded), leaving behind volumetrically rendered colored voxels corresponding the highest intensities in the sensor produced images.
[0090] The change in opacity to full transparency may appear gradual, or in discrete steps. Using discrete steps may help give the operator a better impression of volume, especially when 3-D displays are not used for visualization. One example in which discrete steps can be used is when only 2 transparency values are used: full transparency and full opacity. For example, the transition between the two states may be set at a point where the calculated MDQ for a specific volumetric element reaches a preset value. For example, when the volumetric element's MDQ is above that limit, full opacity can be associated with that volumetric element, when the MDQ is below that limit, full transparency can be associated with that volumetric element. The value of the preset MDQ may vary and may be determined by the particular scope of the measurement).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of claimed invention, to modify the method and apparatus of Hill, and have graphically representing data sufficiency of the three-dimensional geometric model of the heart by adjusting opacities of the plurality of voxels according to their respective data sufficiencies, as taught by Mihailescu. The modification provides an improved system and method for generating a three-dimensional geometric model of medical image and improve quality of the image data, thereby to improve scanning quality and reduce errors by better defining the precise location of a detected signal. (Mihailescu, see par. [0007]).
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Hill et al. (US 20120169712 A1) in view of Barbagli et al. (US 20120035481 A1) and further in view of Mihailescu et al. (US 20160135762 A1), as applied claim 26 above and further in view of Razzaque et al. (US 20110137156 A1)
Regarding claim 28. Hill in view of Bargagli and further in view of Mihailescu claim 26, but Hill in view of Bargagli and further in view of Mihailescu does not disclose graphically representing data sufficiency of the three-dimensional geometric model of the heart region further comprises outputting a data collection cue. However,
Razzaque discloses:
graphically representing data sufficiency of the three-dimensional geometric model of the heart region further comprises outputting a data collection cue (Razzaque, see at least [0135], The rings may be spaced at regular (e.g., 0.5, 1, or 2 cm) intervals to provide the physician with visual cues regarding the distance from the needle tip to the targeted anatomy. In some embodiments, the spacing of the rings may indicate other aspects of the data, such as the drive speed of the needle, the density of the tissue, the distance to a landmark, such as the ultrasound data, or any other appropriate guidance data or property).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of claimed invention, to modify the method and apparatus of Hill, and have graphically representing data sufficiency of the three-dimensional geometric model of the heart region further comprises outputting a data collection cue, as provided by Razzaque. The modification provide an improved system and method for generating a three-dimensional geometric model of medical image; thereby to aid the surgeon to identify important features in the medical image. In addition, when image guidance cues are co-located with medical display object on the display, the medical device system may switch between displaying the image guidance cue and the medical display object, resulting in a flicker (Razzaque, see par. [0004]).
Regarding claim 29. Hill in view of Bargagli and further in view of Mihailescu claim 28, but Hill in view of Bargagli and further in view of Mihailescu does not disclose wherein the data collection cue is responsive to a rotational speed of the ICE catheter. However,
Razzaque discloses:
wherein the data collection cue is responsive to a rotational speed of the ICE catheter (Razzaque, see at least par. [0055] The rings can be spaced at regular (e.g., 0.5, 1, or 2 cm) intervals to provide the healthcare provider with visual or guidance cues regarding the distance from the medical device tip to the targeted anatomy. In some embodiments, the spacing of the rings can indicate other aspects of the data, such as the drive speed of the medical device, the density of the tissue, the distance to a landmark, such as the ultrasound data, or any other appropriate guidance data or property. In some embodiments, the rings or other trajectory indicators can extend beyond the medical device tip, by a distance equal to the length of the medical device-shaft. This way, the user knows if the medical device is long enough to reach the target--even before the tip enters the patient. That is, in some embodiments, if the rings do not reach the target with the tip still outside the body, then the tip won't reach the target even when the entire length shaft is inserted into the body. [0056] Other display markers can be used to show trajectory, such as a dashed, dotted, or solid line, transparent medical device shaft, point cloud, wire frame, etc. In some embodiments, three-dimensional rings can be used and provide depth cues and obscure little of the ultrasound image. Virtual rings or other virtual markers can be displayed semi-transparently, so that they obscure less of the ultrasound image than an opaque marker would.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of claimed invention, to modify the method and apparatus of Hill, and have wherein the data collection cue is responsive to a rotational speed of the ICE catheter, as provided by Razzaque. The modification provide an improved system and method for generating a three-dimensional geometric model of medical image; thereby to aid the surgeon to identify important features in the medical image. In addition, when image guidance cues are co-located with medical display object on the display, the medical device system may switch between displaying the image guidance cue and the medical display object, resulting in a flicker (Razzaque, see par. [0004]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over in view of Hill et al. (US 20120169712 A1) in view of Barbagli et al. (US 20120035481 A1) and further in view of Mihailescu et al. (US 20160135762 A1), as applied claim 26 above applied claim 26 above, and further in view of KIM (US 20140330121 A1 hereinafter KIM).
Regarding claim 27. Hill in view of Bargagli and further in view of Mihailescu discloses the method of claim 26, but does not teach wherein, for a selected voxel of the plurality of voxels, the opacity of the selected voxel increases as data sufficiency at the selected voxel increases. However,
KIM discloses:
wherein, for a selected voxel of the plurality of voxels, an opacity of the selected voxel increases as data sufficiency at the selected voxel increases (KIM, see at least par. [0166] When the operator wants to obtain information regarding the surface of the target region rather than the inside of the target region, the opacity value may be established as a 2D function with respect to the elasticity value and the voxel value, while only increasing proportionally to the voxel value. Thus, when the elasticity value is 0, the opacity value may be established as a 1D increasing function with respect to the voxel value.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of claimed invention, to modify the method and apparatus of Hill, and have wherein, for a selected voxel of the plurality of voxels, the opacity of the selected voxel increases as data sufficiency at the selected voxel increases, as provided by KIM. The modification provide an improved system and method for generating a three-dimensional geometric model of medical image and provide an ultrasonic imaging apparatus to output a multi-dimensional ultrasonic image of a target region of an object to be diagnosed in which lesion areas are separated from non-lesion tissues using elasticity data of the object and a method of controlling the ultrasonic imaging apparatus. (KIM, see par. [0009]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM THANH THI TRAN whose telephone number is (571)270-1408. The examiner can normally be reached Monday-Friday 8:00am-5:00pm.
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/KIM THANH T TRAN/Examiner, Art Unit 2612
/JAMES A THOMPSON/Primary Examiner, Art Unit 2615
