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 .
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 33, 34, 39, 41, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 9 of U.S. Patent No. 11,819,284 in view of Fujita et al. (US 2015/0223670; hereinafter “Fujita”). Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are considered trivial variations of the patented claims.
The following table illustrates a mapping of the conflicting claims:
Current Application
33
34
39
41
50
Patent 11,819,284
8
8
9
8
1
The following table illustrates a sample mapping of the limitations of claim 33 of the current application when compared against the pertinent limitations of claim 8 of the patent. The remaining claims can be mapped in a similar manner.
Current Application
Patent (pertinent limitations)
33. A medical system comprising: an elongate device including a flexible body; a tracking system disposed along at least a portion of the flexible body;
8. A medical device comprising: an elongate device including a flexible body; a tracking system disposed along at least a portion of the flexible body
a display device;
display at least one portion of the graphical representation
and one or more processors coupled to the tracking system;
one or more processors coupled to the tracking system
wherein the one or more processors are configured to: receive data from the tracking system; based on the received data, determine a bending condition of a distal portion of the flexible body;
wherein the one or more processors are configured to: receive data from the tracking system; calculate a bend radius along a length of the flexible body based on the received data
and display a bend indicator on the display device, wherein the bend indicator visually indicates … a degree of the bending condition of the distal portion of the flexible body
display at least one portion of the graphical representation of the flexible body with a different visual property … based on the bend radius
The patented claims do not recite the bend indicator visually indicating a bending direction of the current bending condition.
In the same art of displaying bending indicators for a flexible medical instrument, Fujita teaches displaying a bend indicator on the display device, wherein the bend indicator visually indicates a direction and a degree of the bending condition of the distal portion of the flexible body (“the two-dimensional views 6421 and 6422 are produced by the control section 66 on the basis of the shape information of the inserting section 31,” para. 90; see Fig. 1C which illustrates a display output of bending direction and degree).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Fujita to the patented claims. The motivation would have been “the output can be easy to understand (easy to see, hard to be mistaken, or can quickly be judged)” (Fujita, para. 16).
Claims 33, 34, 39, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 10 of U.S. Patent No. 12,274,514 in view of Fujita et al. (US 2015/0223670; hereinafter “Fujita”). Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are considered trivial variations of the patented claims.
The following table illustrates a mapping of the conflicting claims:
Current Application
33
34
39
50
Patent 11,819,284
9
9
10
1
The following table illustrates a sample mapping of the limitations of claim 33 of the current application when compared against the pertinent limitations of claim 9 of the patent. The remaining claims can be mapped in a similar manner.
Current Application
Patent (pertinent limitations)
33. A medical system comprising: an elongate device including a flexible body; a tracking system disposed along at least a portion of the flexible body;
9. A medical system comprising: an elongate device including a flexible body; a tracking system disposed along at least a portion of the flexible body;
a display device;
a display device;
and one or more processors coupled to the tracking system;
one or more processors coupled to the tracking system;
wherein the one or more processors are configured to: receive data from the tracking system; based on the received data, determine a bending condition of a distal portion of the flexible body;
wherein the one or more processors are configured to: receive data from the tracking system; based on the received data, determine a buckling condition along a length of the flexible body;
and display a bend indicator on the display device
using the supplemental guidance information, augment one or more images
The patented claims do not recite wherein the bend indicator visually indicates a direction and a degree of the [current] bending condition of the distal portion of the flexible body.
In the same art of displaying bending indicators for a flexible medical instrument, Fujita teaches displaying a bend indicator on the display device, wherein the bend indicator visually indicates a direction and a degree of the bending condition of the distal portion of the flexible body (“the two-dimensional views 6421 and 6422 are produced by the control section 66 on the basis of the shape information of the inserting section 31,” para. 90; see Fig. 1C which illustrates a display output of bending direction and degree).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Fujita to the patented claims. The motivation would have been “the output can be easy to understand (easy to see, hard to be mistaken, or can quickly be judged)” (Fujita, para. 16).
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.
Claim 36 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 36 lacks proper antecedent basis for the phrase “the representation,” and therefore the scope of the claim is unclear. It appears that claim 36 is meant to depend on claim 35, which would provide proper antecedent basis.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 33, 34, 39, 49, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujita et al. (US 2015/0223670; hereinafter “Fujita”).
Regarding claim 33, Fujita discloses A medical system (“an endoscope or a catheter … to perform an observation or an operation,” para. 3) comprising: an elongate device including a flexible body (“an inserting tool 3 including an inserting section 31 to be inserted into an insertion subject 2,” para. 57; “the inserting section 31 includes a bending portion 35,” para. 60); a tracking system disposed along at least a portion of the flexible body (“a fiber shape sensor 5 as detecting sections that detect displacement amount information of the inserting section 31,” para. 57); a display device (“display and output the calculation result,” para. 57); and one or more processors coupled to the tracking system (“the computer executes this program,” para. 147); wherein the one or more processors are configured to: receive data from the tracking system; based on the received data, determine a bending condition of a distal portion of the flexible body (“The fiber shape sensor 5 is constituted of optical fibers, and one of the optical fibers has a bend detecting portion 51,” para. 67; “detect a bend amount of one region,” para. 68); and display a bend indicator on the display device, wherein the bend indicator visually indicates a direction and a degree of the bending condition of the distal portion of the flexible body (“the two-dimensional views 6421 and 6422 are produced by the control section 66 on the basis of the shape information of the inserting section 31,” para. 90; see Fig. 1C which illustrates a display output of bending direction and degree).
Regarding claim 34, Fujita discloses wherein the distal portion of the flexible body includes a distal tip of the flexible body (e.g. Fig. 2A).
Regarding claim 39, Fujita discloses wherein the tracking system includes a shape sensor configured to generate the received data (“The fiber shape sensor 5 is constituted of optical fibers, and one of the optical fibers has a bend detecting portion 51,” para. 67).
Regarding claim 49, Fujita discloses wherein the bend indicator visually depicts the distal portion of the flexible body only and portions of the flexible body proximal of the distal portion are hidden (e.g. Fig. 1C).
Regarding claim 50, it is rejected using the same citations and rationales described in the rejection of claim 33.
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.
Claims 35-38, 40, 46-48, 51, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita in view of Ambwani et al. (US 2016/0335766; hereinafter “Ambwani”).
Regarding claim 35, Fujita discloses wherein the bend indicator includes a representation of the distal portion of the flexible body (see Fig. 1C).
Fujita does not explicitly specify whether the views in Fig. 1C are facing in a distal or proximal direction, therefore Fujita does not specifically recite the claimed from a perspective along a length of the flexible body facing distally toward the distal tip.
In the same art of in-vivo imaging and medical device delivery, Ambwani teaches displaying a graphical representation from a perspective along a length of the flexible body facing distally toward the distal tip (“the various circles/line segments C1, C2 in the top right view can be rotated to navigate through various views of the image. FIGS. 8A to 9B show additional interfaces and control information for navigating image data sets and performing diagnostics such as stent planning. Various proximal and distal views and other perspective views can be navigated using the tools shown herein,” para. 79).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Ambwani to Fujita. The motivation would have been “to facilitate stent delivery planning and stent deployment” (Ambwani, para. 5).
Regarding claim 36, Fujita discloses wherein a portion of the representation of the distal portion of the flexible body remains centered in the bend indicator as the distal tip is moved (the circles on the right side of Fig. 1C illustrate part of the distal portion of the flexible body remaining centered).
Fujita does not explicitly specify whether the views in Fig. 1C are facing in a distal or proximal direction, therefore Fujita does not specifically recite whether it is the proximal portion that remains centered (as opposed to the distal tip).
In the same art of in-vivo imaging and medical device delivery using a flexible insertion device, Ambwani teaches various perspective views: “the various circles/line segments C1, C2 in the top right view can be rotated to navigate through various views of the image. FIGS. 8A to 9B show additional interfaces and control information for navigating image data sets and performing diagnostics such as stent planning. Various proximal and distal views and other perspective views can be navigated using the tools shown herein” (para. 79).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Ambwani to Fujita, thereby rendering obvious a distally-facing perspective where the portion of Fig. 1C of Fujita that remains centered is the proximal portion. The motivation would have been “to facilitate stent delivery planning and stent deployment” (Ambwani, para. 5).
Regarding claim 37, Fujita discloses wherein the bend indicator includes a representation of the distal portion of the flexible body (see Fig. 1C).
Fujita does not explicitly specify whether the views in Fig. 1C are facing in a distal or proximal direction, therefore Fujita does not specifically recite the claimed from a perspective distal of the distal tip and facing proximally toward the flexible body.
In the same art of in-vivo imaging and medical device delivery, Ambwani teaches displaying a graphical representation from a perspective distal of the distal tip and facing proximally toward the flexible body (“the various circles/line segments C1, C2 in the top right view can be rotated to navigate through various views of the image. FIGS. 8A to 9B show additional interfaces and control information for navigating image data sets and performing diagnostics such as stent planning. Various proximal and distal views and other perspective views can be navigated using the tools shown herein,” para. 79).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Ambwani to Fujita. The motivation would have been “to facilitate stent delivery planning and stent deployment” (Ambwani, para. 5).
Regarding claim 38, the combination of Fujita and Ambwani renders obvious wherein the distal tip of the flexible body remains centered in the bend indicator as the distal tip is moved (the circles on the right side of Fig. 1C of Fujita illustrate part of the distal portion of the flexible body remaining centered, Ambwani renders obvious a proximally-facing perspective, and when the perspective of Ambwani is applied to Fujita, the combination would render obvious the distal tip remaining centered; see claim 37 for motivation to combine).
Regarding claim 40, it is rejected using the same citations and rationales described in the rejection of claim 35.
Regarding claim 46, Fujita discloses display the bend indicator in a first window and … display a graphical representation of the flexible body in a second window (Fig. 1C illustrates multiple windows including bend indicators and graphical representations of the flexible body).
Fujita does not disclose select a viewing angle of the graphical representation of the flexible body in the second window to optimize viewability of the bending condition.
In the same art of in-vivo imaging and medical device delivery, Ambwani teaches select a viewing angle of the graphical representation of the flexible body in the second window to optimize viewability (“as shown in FIG. 5, an indicator W is used to point to a guidewire image … FIG. 6 shows a three-dimensional fly though,” para. 78; “the various circles/line segments C1, C2 in the top right view can be rotated to navigate through various views of the image. FIGS. 8A to 9B show additional interfaces and control information for navigating image data sets and performing diagnostics such as stent planning. Various proximal and distal views and other perspective views can be navigated using the tools shown herein,” para. 79).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Ambwani to Fujita, thereby optimizing viewability of the bending condition. The motivation would have been “to facilitate stent delivery planning and stent deployment” (Ambwani, para. 5).
Regarding claim 47, the combination of Fujita and Ambwani renders obvious wherein the second window displays a virtual global view of the flexible body and a three-dimensional anatomical model (e.g. Figs. 5 and 6 of Ambwani illustrate a virtual global view of a flexible guidewire W and a three-dimensional anatomical model; see claim 46 for motivation to combine).
Regarding claim 48, Fujita discloses display the bend indicator in a first window and … display a graphical representation of the flexible body in a second window (Fig. 1C illustrates multiple windows including bend indicators and graphical representations of the flexible body).
Fujita does not disclose select a viewing angle of the graphical representation of the flexible body in the second window that corresponds to a view of an intraoperative imaging device.
In the same art of in-vivo imaging and medical device delivery, Ambwani teaches select a viewing angle of the graphical representation of the flexible body in the second window that corresponds to a view of an intraoperative imaging device (“as shown in FIG. 5, an indicator W is used to point to a guidewire image … FIG. 6 shows a three-dimensional fly though,” para. 78; “a stent strut indicator and overlaid on angiography frames co-registered with an intravascular data set such as a set of OCT scan lines or images generated with respect thereto,” para. 10; “FIG. 2B shows a zoomed view of the angiography image of FIG. 1 which is co-registered with the OCT data of FIG. 1,” para. 70; “the various circles/line segments C1, C2 in the top right view can be rotated to navigate through various views of the image. FIGS. 8A to 9B show additional interfaces and control information for navigating image data sets and performing diagnostics such as stent planning. Various proximal and distal views and other perspective views can be navigated using the tools shown herein,” para. 79).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Ambwani to Fujita. The motivation would have been “to facilitate stent delivery planning and stent deployment” (Ambwani, para. 5).
Regarding claims 51 and 52, they are rejected using the same citations and rationales described in the rejections of claims 35 and 37, respectively.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Fujita in view of Koudijs et al. (US 2012/0120091; hereinafter “Koudijs”).
Regarding claim 41, Fujita does not disclose augment the bend indicator by applying a color scheme to a graphical representation of the flexible body, wherein at least one portion of the graphical representation of the flexible body corresponding to a first degree of bending is shaded differently than another portion of the graphical representation of the flexible body corresponding to a second degree of bending.
In the same art of computer-assisted medical procedures, Koudijs teaches augment the bend indicator by applying a color scheme to a graphical representation of the flexible body, wherein at least one portion of the graphical representation of the flexible body corresponding to a first degree of bending is shaded differently than another portion of the graphical representation of the flexible body corresponding to a second degree of bending (“The surgical tool may, e.g., not be suitable for turning sharp corners,” para. 10; “it may not be possible to take sharp corners ... the violating part of the surgical path is marked as a restricted segment,” para. 34; “different color intensities may be used for indicating how much the … tool restriction is violated. If, e.g., the surgical path is green for the segments without any problem, segments with smaller problems ... may turn a little red and segments with bigger problems ... may be fully red,” para. 38; Fig. 4 illustrates adjacent/contiguous segments 43 and 44 in different alert ranges, and although this particular example illustrates safety margin alerts, it is clear that the same techniques would be applied to tool restriction/bend alerts).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Koudijs to Fujita. The motivation would have been “to optimize the surgical path before as well as during surgery” (Koudijs, para. 4).
Claims 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita in view of Taniguchi et al. (US 6,432,041; hereinafter “Taniguchi”).
Regarding claim 42, Fujita does not disclose wherein the bend indicator includes an alphanumeric representation of the degree of the bending condition.
In the same art of determining a bend amount of a flexible medical device, Taniguchi teaches wherein the bend indicator includes an alphanumeric representation of the degree of the bending condition (“As shown in FIG. 108, the monitor 24a displays the insertion shape graphics, marking graphics, and marking values. The monitor 24A displays graphics indicating the curvature radius display position for each place wherein the curvature radius of the insertion portion 7 is under a certain value, such as 25 cm for example, and also characters indicating the curvature radius near the graphic representation, and graphics indicating the curvature center position,” col. 67, lines 20-30).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Taniguchi to Fujita. The motivation would have been for “improving the efficiency of endoscopic examination” (Taniguchi, col. 6, lines 10-15).
Regarding claim 43, Fujita does not disclose wherein at least a portion of the bend indicator is hidden when the degree of the bending condition is below a threshold value and is displayed when the degree of the bending condition exceeds the threshold value.
In the same art of determining a bend amount of an flexible medical insertion device, Taniguchi teaches wherein at least a portion of the bend indicator is hidden when the degree of the bending condition is below a threshold value and is displayed when the degree of the bending condition exceeds the threshold value (“As shown in FIG. 108, the monitor 24a displays the insertion shape graphics, marking graphics, and marking values. The monitor 24A displays graphics indicating the curvature radius display position for each place wherein the curvature radius of the insertion portion 7 is under a certain value, such as 25 cm for example, and also characters indicating the curvature radius near the graphic representation, and graphics indicating the curvature center position,” col. 67, lines 20-30).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Taniguchi to Fujita. The motivation would have been for “improving the efficiency of endoscopic examination” (Taniguchi, col. 6, lines 10-15).
Claims 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Fujita and Taniguchi, and further in view of Lwin et al. (US 2019/0053861; hereinafter “Lwin”).
Regarding claim 44, the combination of Fujita and Taniguchi does not recite wherein the threshold value is determined based on at least one of manual selection, a type of the elongate device, or a type of a tool configured to pass through the flexible body.
In the same art of determining a bend amount of a flexible medical insertion device, Lwin teaches wherein the threshold value is determined based on at least one of manual selection, a type of the elongate device, or a type of a tool configured to pass through the flexible body (“When the bending angle of the bending section exceeds the maximum bending angle at which the surgical instrument can be inserted, a warning sign can be displayed,” para. 95).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the teachings of Lwin to the combination of Fujita and Taniguchi. The motivation would have been for “surgical instrument damage protection through bending angle sensing” (Lwin, para. 1).
Regarding claim 45, the combination of Fujita, Taniguchi, and Lwin renders obvious wherein the threshold value is determined based on the type of the tool and corresponds to a minimum allowable bend radius of the flexible body that permits unimpeded passage of the tool through the flexible body (“When the bending angle of the bending section exceeds the maximum bending angle at which the surgical instrument can be inserted, a warning sign can be displayed,” Lwin, para. 95; see claim 44 for motivation to combine).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ryan McCulley whose telephone number is (571)270-3754. The examiner can normally be reached Monday through Friday, 8:00am - 4:30pm.
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/RYAN MCCULLEY/Primary Examiner, Art Unit 2611
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