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 .
Status of Claims
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 1, 4, 10, and 13 were amended. Claims 1-18 are currently pending in this application.
Drawings
The drawings were received on 4/17/25. These drawings are unacceptable.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the part corresponding to reference number 40 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
(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.
Claims 1-6, 8-15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuason et al. (US 20190060003 A1, hereinafter Tuason).
Regarding Claim 1 and Claim 10, Tuason teaches a medical system (70), comprising:
a utility probe (i.e. a delivery catheter (186) for insertion into a cavity of an organ (i.e. a patient (72)) (at least fig. 6a [see below] and corresponding disclosure in at least [0053]) comprising:
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a distal end effector (189) fitted at a distal end (at 189) of the utility probe (Fig 12 and [0053] disclose a prosthetic valve, which is placed at the distal end of the catheter)
a first sensor, configured to output first signals indicative of first positions of the distal end effector inside the cavity (positioning sensors are mentioned but not shown in the figure, positioned at the distal portions of the catheters (186, 188), corresponding disclosure at least [0053]).
an ultrasound probe for insertion into an organ of a body (an ECHO imaging catheter (188) disclosed in [0053] and fig. 11 for insertion into the organ of the body) comprising:
an ultrasound transducer array configured to image a volume of the organ, the volume comprising at least a portion of the distal end effector (see ECHO imaging catheter with an ultrasound transducer array as shown in below re-produced fig. 11, which is configured to image a volume (184) and confirm the proper position of the delivery catheter (186). The ECHO imaging catheter (188) also includes electrodes/sensors on the distal end, which is disclosed at least in fig. 8a, 8b, and [0049]).
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and a second sensor configured to output second signals indicative of second positions of the ultrasound transducer array inside the cavity (corresponding disclosure in at least [0017], where multiple position indicators (sensors) are configured for locating the position of the distal end; having multiple sensors would indicate a second position “The delivery catheter distal end may comprise one or more position indicators thereon configured to provide information to the real-time imaging system and/or 3D imaging system regarding the position of the delivery catheter distal end”).
a processor (88), which is configured to:
using the imaged volume, the first positions, and the second positions, select one or more of slices of the imaged volume that comprise at least part of the distal end effector in spatial relation with the organ (corresponding disclosure in at least [0052] and Figure 10, where an ECHO image (slice) is selected and can be viewed in Figure 10, with the distal end in view in relation to the surrounding organs “ an ECHO image 164 in side-to-side configuration, where a heart 10 is depicted as well as a valve delivery catheter 166, prosthetic valve 168, and ECHO catheter 170”) ; generate from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector(189); and present the at least one of the biplane view and triplane view to a user (at least fig. 10 shows the 2D and 3D imaging; fig 11 and 12, which display the prosthetic (i.e. artificial) valve of the 3D mapped image alongside the ECHO image, which is a 2D view, and corresponding disclosure in at least [0052]).
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Figure 10 of Tuason
Regarding Claim 2 and Claim 11,
Tuason further teaches wherein the part of the distal end effector comprises one of expandable splines and expandable arms. The catheter (186) incorporates an elongated shaft (132) at the distal end (189) with a distal array (142), which can be extended outwards. The expansion occurs through the use of a push rod (123) (corresponding disclosure in at least [0049] and [0050]).
Regarding Claim 3 and Claim 12, Tuason further teaches wherein part of the distal end effector comprises an artificial valve (189) (at least [0053] and fig. 11).
Claims 4 and 13 are rejected, Tuason further teaches wherein the ultrasound probe is an intracardiac echography (ICE) four-dimensional (4D) ultrasound (US) catheter (186). A “four-dimensional (4D) US probe” acquires a series of 3D ultrasound (US) images over time, which is completed through the use of a 3D imaging system (80) via a communication cable (102), and real-time movements (104) can be captured (corresponding disclosure in at least [0048]).
Regarding Claim 5 and Claim 14, Tuason further teaches wherein the first and second sensors are magnetic position sensors configured to generate the first and second signals in response to a magnetic field applied by a position tracking system (corresponding disclosure in at least [0009], [0011], and [0012], the catheter has one or more tracking electrode/sensor, which interacts with an external sensor/electromagnetic array, or magnetic coils to track the position of the catheter tracking sensor/electrode).
Regarding Claim 6 and Claim 15, Tuason further teaches wherein the first sensor is an electrode of the distal end effector configured to generate the first signals as part of an electrical position tracking system (An electrode/sensory array (142) is positioned distally alongside the prosthetic valve (138), which is on the distal end effector (189) (corresponding disclosure in at least [0050] and in fig. 9b)).
Regarding Claim 8 and Claim 17, Tuason further teaches wherein the processor is configured to generate from one or more selected slices at least one of a biplane view and triplane view using an image processing algorithm. A biplane and triplane view can be selected using an overlaid display (190) of various views (162, 164, 172) of the position of the valve delivery catheter (186) (corresponding disclosure in at least fig. 10, fig. 12 and [0054]).
Regarding Claim 9 and Claim 18, Tuason further teaches wherein the cavity of the organ is a cardiac chamber of a heart (10) (corresponding disclosure in at least [0040]).
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.
In the alternative,
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tuason et al., in view of Subramaniam et al. (US 9687166 B2).
Regarding Claim 2 and Claim 11, Tuason teaches the elements of claims 1 and 10 as previously stated. Tuason further teaches the catheter (188) incorporating an elongated shaft (132) at the distal end (189) with a distal array (142), which can be extended outwards. (corresponding disclosure in at least [0049] and [0050]). In an interpretation if one argues that (which the office does not concede), Tuason fails to explicitly teach a distal end effector, specifically one that is expandable.
Nonetheless, Subramaniam teaches a catheter device that has a distal end that can have various assembly attachments, such as an expandable configuration (24, 26) or an expandable balloon-like structure (corresponding disclosure in at least Fig. 2 and at least col 5, lines 32-60). The reference goes to further state that “other shapes and/or configurations are contemplated” and various other assemblies can be used (corresponding disclosure in at least col 6, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have any configuration at the end of a distal end effector, as taught by Subramaniam. One of ordinary skill in the art would have been motivated to take the idea of having various configurations of a distal end effector based on what is best suited for the use.
In the alternative,
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Tuason et al., in view of Kanade et al. (US 8480588 B2).
Regarding Claim 4 and Claim 13, Tuason teaches the elements of claims 1 and 10 as previously stated. Tuason further teaches the use of a real-time imaging system (100), such as fluoroscopy or ECHO or CT, which can be combined with a 3D imaging system (80) to provide 3D images over time (corresponding disclosure in at least [0048]). While this covers the scope of a 4D catheter device, it takes the use of two modalities.
Thus, in an interpretation if one argues that (which the office does not concede), Tuason fails to explicitly teach wherein the device is a single intracardiac echography (ICE) 4D ultrasound (US) catheter.
Nonetheless, Kanade teaches an ultrasound catheter device that is capable of performing 4D imaging. The 4D ultrasound catheter in the reference further states that the “high-resolution model may be a 2D or 3D image of static anatomy, or it may be a 4D model in which the fourth dimension depicts changes in the anatomy as a function of time…”, which aligns with the defined term for 4D imaging (corresponding disclosure in at least column 2, lines 23-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a 4D ultrasound catheter during medical procedures for high resolution real-time imaging, as taught by Kanade. One of ordinary skill in the art would have been motivated to use this system because of the inaccuracies that can be seen with current inventions and the complexities of organs (i.e. the heart), leading to inefficiency and complications (corresponding disclosure in at least column 1, lines 28-32).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tuason et al., in view of Urman et al. (US 20240173016 A1).
Regarding Claim 7 and Claim 16, Tuason teaches the elements of claim 7 and 16 as previously stated. Tuason further teaches that the user of the device can view various images (162, 164, 172) on the display (160) for purposes of guiding the prosthetic valve positioning (corresponding disclosure in at least [0052]). While this covers the scope of being able to select image slices, it does not mention a processor. Thus, Tuason fails to explicitly teach wherein the system has a processor for selecting one or more slices using an image processing algorithm.
Nonetheless, Urman teaches a processor (77) that is “configured to select one or more pairs of 2D slices of the 3D US images (60, 70)…” where the processor has an algorithm for image identification and selection (corresponding disclosure in at least fig. 3a and fig. 2b and pg. 10 line 29-30, pg. 11 line 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a processor or algorithm in place for ultrasound image selection, as disclosed by Urman. One of ordinary skill in the art would have been motivated to have a processor to display the necessary ultrasound slices for the respective purposes (selection of ultrasound images where ablation occurs, or where the distal end is located). In particular, having the 3D image alone is not sufficient as they “may not provide physician(s) with sufficient information for assessing the quality…” (corresponding disclosure in [0057]). Therefore, having the processor for 2D ultrasound slice selection provides more information for quality assurance.
Response to Arguments
For purposes of clarity of the record, the Examiner notes that the amendments to the specification dated 4/17/25 are accepted.
With respect to the claim objections, the amendment dated 4/17/25 obviates the issues and so these objections have been withdrawn.
With respect to the drawing objections, the Examiner notes that the changes dated 4/17/25 are not accepted. Figure 1 was objected to previously due to the distal end effector 40 not being clearly annotated. It is still unclear what reference character 40 is pointing to.
Applicant's arguments filed 4/17/25 with respect to the rejections under 35 U.S.C. 102(a)(1) have been fully considered but they are not persuasive.
Regarding Claim 1, the applicant argues, see Pages 8 and 9, that Tuason does not teach or suggest slices of the imaged volume in any capacity, let alone the claimed limitations of "using the imaged volume, the first positions, and the second positions, select one or more slices of the imaged volume that comprise at least part of the distal end effector in spatial relation with the organ," and "generate from the one or more selected slices at least one of a biplane view and triplane view of the part of the distal end effector." The examiner respectfully disagrees that these features are not disclosed by Tuason. Specifically, Figure 11 of Tuason shows an ECHO image of the volume, where “The user (e.g., physician) can view the combined images on the display 180 and use the information provided to guide the proper positioning of the prosthetic valve (i.e. the distal end)” (corresponding disclosure in at least [0053]). In regards to the selection of one or more slices of the imaged volume that comprise at least part of the distal end effector in spatial relation with the organ, corresponding disclosure can be found in at least [0052], where an ECHO image (slice) is selected and can be viewed in Figure 10, with the distal end in view in relation to the surrounding organs “ an ECHO image 164 in side-to-side configuration, where a heart 10 is depicted as well as a valve delivery catheter 166, prosthetic valve 168, and ECHO catheter 170”. Further, the biplane and triplane view views are generated with views of the distal end effector (the valve) (at least fig. 10 shows the 2D and 3D imaging; fig 11 and 12, which display the prosthetic (i.e. artificial) valve of the 3D mapped image alongside the ECHO image, and corresponding disclosure in at least [0052]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.K./Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797