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 .
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 03/04/2026. Claims 1-10, 12, 14-15, 18-20, 23, 25, 62, and 64 are pending. Claims 16-17, 21-22, 24, and 26-61, and 63 are cancelled. Claims 1 and 14 are amended. Claim 64 is newly added. Claims 1-10, 12, 14-15, 18-20, 23, 25, 62, and 64 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Applicant’s request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action (i.e. dated 01/07/2026) is withdrawn.
The examiner notes that this final office action replaces the final rejection of 01/07/2026.
The examiner respectfully refers the Applicant to MPEP 706.07(a): “Second or any subsequent actions on the merits shall be final, except where the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p).”.
Response to Arguments
Applicant’s arguments, see Remarks, page 7-8, filed 03/04/2026 with respect to the finality of the office action of 01/07/2026 have been fully considered and are persuasive.
The examiner acknowledges that the finality of the office action (i.e. of 01/07/2026) introducing the new ground of rejection is procedurally improper. The examiner recognizes that the amendment made in the prior response merely incorporated the subject matter from previously presented dependent claim 13 (including the subject matter of intervening dependent claim 11) into independent claim 1. Therefore, claim 1 did not introduce new subject matter, and thus did not require a new search, and did not present new issues for consideration. The subject matter was already of record and was previously examined by the Office.
Furthermore, claims 62 and 63 were added in response to the non-final office action. Claims 62 and 63 were never properly rejected on a non-final basis because the pending Office Action introduced a new ground of rejection that was not necessitated by amendment.
The examiner has withdrawn the finality of the rejection of 01/07/2026 and instead issues a new final rejection to incorporate the subject matter of previously presented dependent claim 13 (including the subject matter of claim 11) into independent claim 1. Furthermore, this rejection also addresses the features of claim 63 which was incorporated into claim 1 as well.
Applicant’s arguments, see Remarks page 8-9, filed 03/04/2026, with respect to the rejection of claims 1-2, 12, 14-15, 18-20, 23 and 62-63 under 35 U.S.C. 103 have been fully considered and are persuasive.
Regarding claim 1, the claim has been amended to incorporate the limitations of claim 63. Therefore, claim 1 further recites “wherein generating the three-dimensional image based on the plurality of image data sets comprises: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image with anatomical features identified in the second two-dimensional image; and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features, the first localization data, and the second localization data”. Because, as discussed above, the Applicant argues that since claim 63 was never rejected on a non-final basis, any subsequent action rejecting claim 1 cannot be made final.
As discussed during the interview, the Applicant notes that cited paragraphs [0068] and [0077] of Zhai fail to teach the above-emphasized features of amended claim 1.
Paragraph [0068] of Zhao states that “although the image 650 is two-dimensional, a three-dimensional image may be constructed from a plurality of two-dimensional ultrasound scans”. Paragraph [0077] of Zhao states “a three-dimensional image may be constructed from two-dimensional scans”. Regarding these statements in the cited paragraphs of Zhao, the Office Action on page 19 alleges that “in order to generate a three-dimensional image from a plurality of two-dimensional images, the anatomical structures present within the images must be identified and matched in order to ensure that the three-dimensional image accurately depicts the anatomy”.
The Applicant respectfully submits that nowhere do the cited paragraphs of Zhao teach such an assumption by the office. Similarly, the Applicant argues that nowhere do cited paragraphs [0068] and [0077] teach “wherein generating the three-dimensional image based on the plurality of image data sets comprises: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image; and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features, the first localization data and the second localization data” as recited by amended claim 1.
As such, the cited portions of Zhao in view of Holsing fails to teach the features of amended claim 1. Thus, the Applicant argues that amended claim 1 is allowable over the cited portions of Zhao in view of Holsing. Further, claims 2-10, 12, 14-15, 18-20, 23, 25 and 62, which depend from claim 1 and recite additional features, are allowable over the cited portions of the cited art for at least the same reasons as those discussed above with respect to amended claim 1, and further in view of their own respective features.
At the onset, the examiner respectfully acknowledges that Zhao includes channel 219 which is used to advance a tool 228 to perform a procedure (see [0049]). However, the examiner respectfully maintains that Zhao teaches “wherein the elongate flexible instrument further includes a tool channel, and wherein the tool channel terminates on a side wall of the elongate flexible instrument” (see [0049]: “The interventional tool 228 may be removed from the proximal end 217 of the catheter flexible body or from another optional instrument port (not shown) along the flexible body”. Thus, the optional instrument port along the flexible body represents a tool channel which terminates on a side wall of the elongate flexible instrument (i.e. 216) for the reasons stated in the 35 U.S.C. 103 section below.
Furthermore, the examiner respectfully maintains that incorporating the limitations of claim 63 into claim 1 can result in the rejection being made final. The finality of the office action of 01/07/2026 was withdrawn, therefore the limitations of claim 63 (i.e. now incorporated into claim 1) represent newly added limitations which necessitate new ground(s) of rejection. Furthermore, the Applicant has amended the claims to include claim 64, thereby making a final rejection proper (see MPEP 706.07(a) cited above).
In spite of this, the examiner respectfully acknowledges that cited paragraphs [0068] and [0077] of Zhao fail to teach the above-emphasized features of amended claim 1 (i.e. the limitations disclosed in previous claim 63).
Paragraph [0068] states “although the image 650 is two-dimensional, a three-dimensional image may be constructed from a plurality of two-dimensional ultrasound scans”. Furthermore, paragraph [0077] states “a three-dimensional image may be constructed from two-dimensional scans”. The examiner acknowledges that Zhao does not support the allegation that “in order to generate a three-dimensional image from a plurality of two-dimensional images, the anatomical structures present within the images must be identified and matched in order to ensure that the three-dimensional image accurately depicts the anatomy”, as stated in the office action of 01/07/2026 on page 19 (i.e. now withdrawn).
Therefore, the rejection (i.e. with respect to the limitations of claim 63, specifically) has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hunter et al. US 2022/0375114 A1 “Hunter” as discussed in the 35 U.S.C. 103 section below.
Thus, the rejection of claim 1 has been updated to reflect the amended limitations.
Regarding claims 2, 10, 12, 15, 18-20, and 23, these claims depend from claim 1 and recite additional features which are taught by Zhao. Due to their dependence on claim 1 these claims are subject to the new ground(s) of rejection made in view of Hunter et al. US 2022/0375114 A1 “Hunter” as stated in the 35 U.S.C. 103 section below.
Regarding claim 14, the examiner notes that the claim has been amended to recite: “wherein the tool channel terminates at a location on the side wall proximal of a distal end face of the elongate flexible instrument”. While Zhao discloses “The interventional tool 228 may be removed from the proximal end 217 of the catheter flexible body or from another optional instrument port (not shown) along the flexible body” [0049], the examiner acknowledges that the tool channel (i.e. 219) itself does not terminate at a location on the side wall proximal of a distal end face. In FIG. 2 of Zhao, the tool channel 219 terminates on a distal end face of the elongate flexible instrument (i.e. 216).
Therefore, the rejection of claim 14 under 35 U.S.C. 102 in the non-final rejection of 09/11/2025 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Holsing et al. US 2013/0225943 A1 “Holsing” as discussed in the 35 U.S.C. 103 section below.
Regarding newly added claim 64, the examiner respectfully refers the Applicant to the 35 U.S.C. 103 section below with respect to the rejection of this claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2, 12, 15, 18-20, 23, 25, 62, and 64 is/are rejected under 35 U.S.C. 103 as being anticipated by Zhao et al. US 2020/0214664 A1 “Zhao” and further in view of Hunter et al. US 2022/0375114 A1 “Hunter”.
Regarding claims 1 and 64, Zhao teaches “A system comprising:” (Claims 1 and 64) (“FIG. 2 illustrates a minimally invasive system 200 utilizing aspects of the present disclosure. The system 200 may be incorporated into a teleoperated interventional system, such as system 100. […] The system 200 includes a catheter system 202 (e.g., part of the instrument 104) coupled by an interface unit 204 to a tracking system 206” [0036]. Therefore, Zhao discloses a system in FIG. 2.);
“an elongate flexible instrument including an imaging device disposed at a distal portion of the elongate flexible instrument and a localization sensor within the elongate flexible instrument, wherein the elongate flexible instrument further includes a tool channel” (Claim 1); “an elongate flexible instrument including an imaging device disposed at a distal portion of the elongate flexible instrument and a localization sensor within the elongate flexible instrument” (Claim 64) (“The catheter system 202 includes an elongated flexible body 216 having a proximal end 217 and a distal end 218. […] The catheter system 202 optionally includes a sensor system which includes a position sensor system 220 (e.g., an electromagnetic (EM) sensor system) and/or a shape sensor system 222 for determining the position, orientation, speed, pose, and/or shape of the catheter tip at distal end 218 and/or of one or more segments 224 along the body 216” [0037]; “The flexible body 216 may optionally house one or more image capture probes 226 that transmit captured image data to the imaging system(s) 212. For example, the image capture probe 226 may be an endoscopic probe including a tip portion with a stereoscopic or monoscopic camera disposed near the distal end 218 of the flexible body 216 for capturing images (including video images) that are transmitted to the imaging system 212” [0046]; “Additionally or alternatively, the image capture probe 226 may be a sensor probe for use with an imaging technology such as ultrasound, OCT, or DOT. For example, the probe may include a transmitter and receiver arrangement, such as an ultrasound transducer. The ultrasonic transducer can be mounted at an end of an elongated shaft” [0047]; “As shown in greater detail in FIG. 3, interventional tool(s) 228 for such procedures as surgery, biopsy, ablation, illumination, irrigation, or suction can be deployed through the channel 219 of the flexible body 216 and used at a target location within the anatomy. The intervertebral tool 228 may also be the image capture probe. The tool 228 may be advanced from the opening of the channel 219 to perform the procedure and then retracted back into the channel when the procedure is complete The interventional tool 228 may be removed from the proximal end 217 of the catheter flexible body or from another optional instrument port (not shown) along the flexible body.” [0049]. Therefore, the system includes an elongate flexible instrument (i.e. elongate flexible body 216 of catheter system 202) including an imaging device disposed at a distal portion of the elongate flexible instrument (i.e. probe 226, in the form of an ultrasound transducer, for example) and a localization sensor within the elongate flexible instrument (i.e. position sensor system 220 and/or shape sensor system 222), wherein the elongate flexible instrument further includes a tool channel (i.e. channel 219).);
“wherein the tool channel terminates on a side wall of the elongate flexible instrument” (Claim 1) (See [0049] as discussed above. Since the interventional tool 228 may be removed from an optional instrument port along the flexible body (i.e. the port being within a side wall of the elongate flexible instrument), the tool channel (i.e. 219 on which the optional instrument port is located) terminates on a side wall of the elongate flexible instrument.); and
“a controller comprising one or more processors configured to:” (Claims 1 and 64) (“A navigation system 210 (e.g., part of the control system 116) processes information from a virtual visualization system 208, one or more imaging systems 212, and/or the tracking system 206 to generate one or more image displays on a display system 214 (e.g., part of the display system 111)” [0036]. In this case, the control system 116 “includes at least one processor (not shown), and typically a plurality of processors, for effecting control between the slave surgical manipulator assembly 102, the master assembly 106, the visualization system 110, and the display system 111” [0033]. Thus, the control system 116 includes at least one or a plurality of processors (i.e. one or more processors). Therefore, since the navigation system 210 is part of the control system 116 which includes at least one processor (i.e. or a plurality), the system includes a controller comprising one or more processors configured to carry out specific functions.);
“capture a first two-dimensional image with the imaging device in a first imaging configuration” […] “capture a second two-dimensional image with the imaging device in a second imaging configuration” (Claims 1 and 64) (“As a two-dimensional source, the ultrasonic transducer can be used to obtain a single ultrasound image. As a three-dimensional source it can be used to obtain a plurality of spaced ultrasonic images, or cuts, thereby to provide sufficient information for construction of a three-dimensional model. Accordingly, it can be arranged to move, including rotate, within an anatomic site to capture such images, or cuts. This can typically be achieved, for example, in accordance with a pre-programmed sequence for moving the ultrasound transducer by teleoperational control, manual movement of the ultrasound transducer, or the like” [0047] and “A three-dimensional image may be constructed from two-dimensional scans” [0077]. Therefore, when the ultrasound transducer is operated as a three-dimensional source it obtains a plurality of spaced ultrasonic images (i.e. cuts) which are used to construct the three-dimensional model. These cuts represent two-dimensional images which are each associated with a specific location of the distal end of the catheter system 202. Therefore, the controller is configured to capture a first two-dimensional image with the imaging device in a first imaging configuration and a second two-dimensional image with the imaging device in a second imaging configuration.);
“receive first localization data for the distal portion of the elongate flexible instrument from the localization sensor while the imaging device is in the first imaging configuration” […] “receive second localization data for the distal portion of the elongate flexible instrument from the localization sensor while the imaging device is in the second imaging configuration” (Claims 1 and 64) (“As another example, historical pose, position, or orientation data may be stored for a known point of an instrument along a cycle of alternating motion, such as breathing. This stored data may be used to develop shape information about the catheter. […] Alternatively, a history of data from a positional sensor, such as an EM sensor, on the instrument during a procedure may be used to represent the shape of the instrument, particularly if an anatomical passageway is generally static” [0040]; “The position and orientation of the distal end portion 610 may be tracked, as described above, using sensor systems (e.g., position sensor system 220 and/or the shape sensor system 222) interfaced with a tracking system (e.g., tracking system 206)” [0067]. Therefore, the position and orientation of the distal end portion 610 (i.e. of flexible catheter body 608, see FIG. 10a), is tracked during a procedure using the position sensor system 220 and/or the shape sensor system 222. Furthermore, in order to store historical pose, position or orientation data (i.e. representative of the shape of an instrument) of the instrument during a procedure (i.e. involving the collection of first and second image data), the controller must receive first localization data for the distal portion of the elongate flexible instrument (i.e. 216 in FIG. 2, 610 in FIG. 10a, for example) from the localization sensor (i.e. position sensor system 220 and/or shape sensor system 222) while the imaging device is in the first imaging configuration (i.e. associated with first image data) and second localization data for the distal portion of the elongate flexible instrument (i.e. 216 in FIG. 2, 610 in FIG. 10a, for example) from the localization sensor while the imaging device is in the second imaging configuration (i.e. associated with second image data).);
“create a first image data set including the first localization data and the first two- dimensional image” […] “create a second image data set including the second localization data and the second two-dimensional image” (Claims 1 and 64) (See [0047], [0040] and [0067] above and “To transform the image coordinate system to the catheter coordinate system, the relative three-dimensional pose between the image coordinate system and the catheter coordinate system is determined. It can be measured directly by sensors on the catheter and imaging probe. Such sensors may include an EM sensor, fiber optic shape sensor, or the like” [0069]. In this case, each of the spaced ultrasonic images or cuts (i.e. two-dimensional images), used to construct the three-dimensional model (See [0047]), are associated with historical pose, position and orientation data of the distal end of the instrument (i.e. flexible catheter body, 216 in FIG. 2) (see [0040], [0067]). Therefore, in order for the spaced ultrasonic images or cuts, associated with historical pose, position and orientation data to be used to construct a three-dimensional model, the controller had to first create a first image data set including the first localization data and the first two-dimensional image and create a second image data set including the second localization data and the second two-dimensional image.);
“generate a three-dimensional image based on a plurality of image data sets, including the first and second image data sets” (Claims 1 and 64) (See [0047], and [0077] above and “Although the image 650 is two-dimensional, a three-dimensional image may be constructed from a plurality of two-dimensional ultrasound scans” [0068]. Therefore, the controller is configured to generate a three-dimensional image based on a plurality of image data sets, including the first and second image data sets.).
Although Zhao states “The image 650 has an image frame of reference and coordinate system (X.sub.I, Y.sub.I, Z.sub.I). The target structure P.sub.I is identified in the image frame of reference. It may be identified, for example, by a clinician, by an image analysis algorithm, or by a combination of the two. The ultrasound scan may be gated for respiratory and/or cardiac cycles. Although the image 650 is two-dimensional, a three-dimensional image may be constructed from a plurality of two-dimensional ultrasound scans. Data associated with the location of the target structure P.sub.I in the image frame of reference is transformed to the catheter coordinate system or the patient coordinate system (that has been registered with the catheter coordinate system) as P.sub.P” [0068]; “At 510, after the target structure is detected by the probe 606, a clinician may identify the target structure in the image using a pointing device. The image (e.g. the ultrasound image) may be generated by a scan that is gated for respiratory and/or cardiac cycles. A three-dimensional image may be constructed from two-dimensional scans. The location identified by the pointing device is identified and recorded as the pointer location data. At 512, the pointer location data is transformed from the image coordinate system (X.sub.I, Y.sub.I, Z.sub.I) to the catheter coordinate system (X.sub.C, Y.sub.C, Z.sub.C) or to the patient coordinate system (X.sub.P, Y.sub.P, Z.sub.P) (which has been previously registered to the catheter coordinate system)” [0077]; Zhao does not teach “wherein generating the three-dimensional image based on the plurality of image data sets comprises: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image; and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features, the first localization data and the second localization data” (Claims 1 and 64).
Hunter is within the same field of endeavor as the claimed invention because it involves systems and methods for generating three-dimensional measurements using endoscopic video data (See Title).
Hunter teaches “wherein generating the three-dimensional image based on the plurality of image data sets comprises: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image; and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features, the first localization data and the second localization data” (Claims 1 and 64) (“Optionally, the endoscopic imaging device comprises a stereo camera, and wherein capturing the one or more two-dimensional images comprises capturing a first two-dimensional image and a second two-dimensional image using the stereo camera of the endoscopic imaging device” [0073]; “Optionally, generating a three-dimensional model of the area based on the captured one or more two-dimensional images comprises applying a structure-from-motion procedure to the first and second two-dimensional images to generate the three-dimensional model of the area” [0074]; “Optionally, the first point on the one or more two-dimensional images is located on an end of a tool, the second-point on the one or more two dimensional images are located on an anatomical feature of the patient” [0105]; “Optionally, identifying the second point on the one or more two dimensional images comprises: identifying a fluoresced anatomical feature in the one or more captured two-dimensional images” [0106]; “Optionally, identifying the second point on the one or more two dimensional images comprises: applying a machine learning classifier to the one or more captured two-dimensional images to determine the location of an anatomical feature within the one or more captured two-dimensional images” [0107]; “Thus, the three-dimensional images acquired above using the processes described with respect to FIGS. 3-6 can also be combined (i.e., “stitched”) together to form larger single images, and thus can be used to generate three-dimensional models of the patient's anatomy” [0292].
In this case, the structure-from-motion procedure represents an algorithm which can be applied to the two-dimensional images so as to generate depth information about the image and then the depth information can be used to generate a three-dimensional model of the surgical space (see [0007]). Additionally, structure-from-motion process “can include finding corresponding features from each image and tracking those features from one image to the next. Once the features from each of the images acquired at step 604 and 606 are matched, the structure-from-motion process can use the feature trajectories over time to reconstruct their three-dimensional positions and acquire depth information” [0255]. Therefore, “[o]nce the structure-from-motion process is applied to the images at step 610, the process 600 can move to step 612 wherein the depth information acquired by the structure-from-motion process is used to generate a three-dimensional [model] of the surgical space as described above with respect to FIG. 3” [0256].
Therefore, the method carried out by the system involves generating the three-dimensional image (i.e. model, see [0074]) based on the plurality of image data sets (i.e. features and their depth information, see [0255], [0256]) comprises: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image (See [0255]); and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features (i.e. see [0074]; [0255]; [0292]), the first localization data (i.e. depth information of first two-dimensional image) and the second localization data (i.e. depth information of the second two-dimensional image).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zhao such that it generates that three-dimensional image based on the plurality of image data sets by: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image; and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features, the first localization data (i.e. depth information of the first two-dimensional image) and the second localization data (i.e. depth information of the second two-dimensional image) as disclosed in Hunter in order to produce a three-dimensional image which accurately represents the anatomy of the patient (see Hunter: [0291]). Combining multiple frames/images depicting an anatomy or internal portion of a patient is one of a finite number of techniques which can be used to allow a surgeon to view a larger portion of the anatomy in a single image with a reasonable expectation of success (see Hunter: [0291]). Thus, modifying the system of Zhao such that it generates that three-dimensional image based on the plurality of image data sets by: matching anatomical features identified in the first two-dimensional image with anatomical features identified in the second two-dimensional image; and combining the first two-dimensional image and the second two-dimensional image based on the matched anatomical features, the first localization data (i.e. depth information of the first two-dimensional image) and the second localization data (i.e. depth information of the second two-dimensional image) as disclosed in Hunter would yield the predictable result of producing a three-dimensional image which accurately represents the anatomy of the patient such that a physician can perform an assessment thereof.
Regarding claim 2, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the imaging device comprises an ultrasound imaging device” (See [0047] above and “An imaging probe 606 is inserted through the flexible catheter body 608. In one embodiment, the imaging probe is an ultrasound probe” [0066]. This imaging probe 606 is shown in FIG. 10a. Therefore, the imaging device comprises an ultrasound imaging device (i.e. ultrasound probe 606).).
Regarding claim 12, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1, above, respectively, and Zhao further teaches “further comprising an interventional tool extendable through the tool channel” (“A channel 219 extends within the flexible body 216” [0037]; “As shown in greater detail in FIG. 3, interventional tool(s) 228 for such procedures as surgery, biopsy ablation, illumination, irrigation, or suction can be deployed through the channel 219 of the flexible body 216 and used at a target location within the anatomy. […] The tool 228 may be advanced from the opening of the channel 219 to perform the procedure and then retracted back into the channel when the procedure is complete. The interventional tool 228 may be removed from the proximal end 217 of the catheter flexible body or from another optional instrument port (not shown) along the flexible body” [0049]. Therefore, the elongate flexible instrument (i.e. 216) further includes a tool channel (i.e. channel 219). Furthermore, FIG. 3 shows the interventional tools 228 extending through the channel 219. Additionally, the system further comprises an interventional tool extendable through the tool channel (i.e. advanced and retracted within the channel 219).
Regarding claim 15, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the one or more processors are further configured to move the imaging device from the first imaging configuration to the second imaging configuration” (“The teleoperated manipulator assembly 102 is driven by a plurality of actuators (e.g., motors). These motors actively move the teleoperated manipulators in response to commands from the control system 116. The motors are further coupled to the interventional instrument so as to advance the interventional instrument into a naturally or surgically created anatomical orifice and to move the distal end of the interventional instrument in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes)” [0035]; “For example, an encoder associated with a motor that drives the insertion of the probe may be used to determine the insertion length. Alternatively, the movement may be tracked by engaging a stepping motor to control the insertion motion of the imaging probe” [0067]. Therefore, since the control system 116 commands the plurality of actuators of the teleoperated manipulator assembly to advance the interventional instrument (i.e. probe, for example) in multiple degrees of freedom, the one or more processors are further configured to move the imaging device from the first imaging configuration to the second imaging configuration.).
Regarding claim 18, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the one or more processors are further configured to register the three-dimensional image to a pre-operative model” (“In some embodiments, the display system 111 may display a virtual visualization image in which the actual location of the interventional instrument is registered (e.g., dynamically referenced) with preoperative or concurrent images from the modeled anatomy to present the surgeon S with a virtual image of the internal interventional site at the location of the tip of the interventional instrument” [0031]; “The system of claim 33 wherein the anatomic frame of reference is a three-dimensional anatomic frame of reference and wherein identifying the target structure includes identifying a model target structure in a three-dimensional model frame of reference and registering the three-dimensional model frame of reference to the three-dimensional anatomic frame of reference” [Claim 34].
In this case, the location of the interventional instrument is known in three-dimensional space (see [0024]) based on the use of the position sensor system 220 and/or shape sensor system 222 (see [0037]). Thus, since the location of the interventional instrument is registered with preoperative images of the modeled anatomy, by registering the three-dimensional model frame of reference (i.e. the preoperative image) to the three-dimensional anatomic frame of reference (i.e. three-dimensional image), the one or more processors are further configured to register the three-dimensional image to a pre-operative model.).
Regarding claim 19, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the one or more processors are further configured to display the three-dimensional image with a real-time image of an interventional procedure” (“An optional visualization system 110 may include an endoscope system such that a concurrent (real-time) image of the interventional site is provided to surgeon console C. The concurrent image may be, for example, a two- or three-dimensional image captured by an endoscopic probe positioned within the interventional site” [0028]. Therefore, since the visualization system 110 displays a concurrent (real-time) image of the interventional site and the concurrent image may be a three-dimensional image captured by an endoscopic probe positioned within the interventional site (i.e. during an interventional procedure), the one or more processors are further configured to display the three-dimensional image with a real-time image of an interventional procedure.).
Regarding claim 20, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the elongate flexible instrument further includes an optical imaging system” (“The flexible body 216 may optionally house one or more image capture probes 226 that transmit captured image data to the imaging system(s) 212 […] The image capture probe 226 may include a cable coupled to the camera for transmitting the captured image data. Alternatively, the image capture instrument may be a fiber-optic bundle, such as a fiberscope, that coupled to the imaging system. The image capture instrument may be single or multi-spectral, for example capturing image data in the visible spectrum, or capturing image data in the visible and infrared or ultraviolet spectrums” [0046]; “Alternatively, the roll angle and the insertion length of the imaging probe with respect to the catheter may be measured by an optical sensor (e.g., a camera) that is fixed to the catheter observing a visual pattern placed around the imaging probe. The visual pattern may contain features that uniquely determine two-dimensional locations” [0073].
Therefore, since the flexible body 216 can house one or more image capture probes 226 (i.e. image capture instrument) which may be a fiber-optic bundle, single, or multi-spectral camera or optical sensor (i.e. camera) for capturing image data in the visible (i.e. optical/light) spectrum, the elongate flexible instrument further includes an optical imaging system (i.e. fiber-optic bundle, optical sensor, single or multi-spectral camera).).
Regarding claim 23, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the one or more processors are further configured to display a two-dimensional guidance image to guide positioning of the elongate flexible instrument” (“Referring again to FIG. 4, after the navigation planning module evaluates the factors related to the interventional instrument and the patient anatomy, a deployment location 314 on the wall of an anatomic passageway is identified. Optionally, the navigation planning module may provide a suggested navigational path to the deployment location. The clinician can then direct the distal end of the interventional instrument to the deployment location. The clinician may manually control the navigation of the interventional instrument based upon virtual or real image guidance” [0057]. As shown in FIG. 4, the virtual image 300 of target structure 302 is a two-dimensional image containing the flexible body 309 (i.e. elongate flexible instrument, see [0053]). Therefore, since the navigation planning module provides a suggested navigational path to the deployment location (i.e. target structure 302) such that the clinician can then direct the distal end of the interventional instrument (i.e. flexible body 309 with interventional tool 310 passing therethrough, see [0053]) based on real image guidance (i.e. two-dimensional image, see FIG. 4), the one or more processors are further configured to display a two-dimensional guidance image to guide positioning of the elongate flexible instrument.).
Regarding claim 25, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the one or more processors are further configured to: capture a third two-dimensional image with the imaging device” (“the image capture probe 226 may be a sensor probe for use with an imaging technology such as ultrasound […] such as an ultrasound transducer. The ultrasonic transducer can be mounted at an end of an elongated shaft […] As a two-dimensional source, the ultrasonic transducer can be used to obtain a single ultrasound image. As a three-dimensional source it can be used to obtain a plurality of spaced ultrasonic images, or cuts, thereby to provide sufficient information for construction of a three-dimensional model. Accordingly, it can be arranged to move, including rotate, within an anatomic site to capture such images, or cuts. This can typically be achieved, for example, in accordance with a pre-programmed sequence for moving the ultrasound transducer by teleoperational control, manual movement of the ultrasound transducer, or the like” [0047]; “A three-dimensional image may be constructed from two-dimensional scans” [0077]. As stated previously, spaced ultrasonic images or cuts represent two-dimensional images which are used to construct the three-dimensional model/image. It would be obvious to one of ordinary skill in the art to capture a third two-dimensional image with the image capture probe 226 (i.e. ultrasonic transducer) in order to effectively construct the three-dimensional image with multiple images indicative of different characteristics of the target structure.);
“receive a user selection of a reference marker on the third two-dimensional image” (“At 404, a location of a target structure (e.g., a tumor) is identified in the model. Identifying the target structure may include determining or receiving information about the target structure from the model, from user inputs describing the target structure, or from other reference sources. Such information about the target structure may include, for example, the shape of the target structure” [0059]; “wherein the control system is further configured to generate a graphical user interface (GUI) including a target marker representing the target structure” [Claim 40]. Therefore, the one or more processors are configured to receive a user selection (i.e. user input) of a reference marker (i.e. target marker). Additionally, it would be obvious to one of ordinary skill in the art to use any of the two-dimensional images obtained by the system, including a third two-dimensional image, in order to define a reference marker corresponding to the target structure such that an interventional instrument (i.e. 310 in FIG. 4, for example) can be guided thereto (see [0053]).; and
“transform the third two-dimensional image and the reference marker into a three-dimensional coordinate space” (“The confirmation of the location of the target structure and/or the identification of a revised location of the target structure may be performed using an ultrasound system. The use of ultrasound technology for confirmation and revision of the target structure location may allow for greater accuracy in biopsy or other focal therapies directed to nodules with small diameters (e.g., approximately 10 mm or smaller). FIG. 10a illustrates a virtual image 600 of a target structure P.sub.M, such as a tumor, and nearby anatomic passageway's 602. […] The passageways 602 are located in a patient frame of reference with coordinate system (X.sub.P, Y.sub.P, Z.sub.P).[…] The location of the target structure P.sub.M is determined from pre-operative or intra-operative imaging, as previously described, and is transformed to the patient frame of reference. In this embodiment, the anatomic passageways are bronchial passageways of the lung, but the systems and methods of this disclosure may be suitable for use in other natural or surgically created passageways in anatomical systems such as the colon, the intestines, the kidneys, the heart, or the circulatory system. As previously described, a flexible catheter body 608 (substantially similar to flexible body 216) may be navigated to a catheter park location that allows access to a target structure. […] An imaging probe 606 is inserted through the flexible catheter body 608” [0066]; “Data associated with the location of the target structure P.sub.I in the image frame of reference is transformed to the catheter coordinate system or the patient coordinate system (that has been registered with the catheter coordinate system) as P.sub.P. The location of the target structure P.sub.P as determined by the ultrasound probe may be compared to the location of the target structure P.sub.M determined from pre-operative or intra-operative imaging in the catheter or patient frame of reference to determine a correction vector 614” [0068]; “To transform the image coordinate system to the catheter coordinate system, the relative three-dimensional pose between the image coordinate system and the catheter coordinate system is determined” [0069].
In this case, the location of the target structure (i.e. corresponding to the reference marker) is determined from pre-operative or intra-operative imaging based on a user input, for example (see [0059], [Claim 40] above). After the location of the target structure is determined, it is transformed to the patient frame of reference (i.e. which is registered with the catheter coordinate system, see [0068]). The patient frame of reference includes bronchial passageways of the lung or any suitable other natural or surgically created passageways in anatomical systems (i.e. colon, intestines, kidneys, heart, circulatory system), each of which are located in three-dimensional space and thus possess a three-dimensional coordinate space. Since the location of the target structure in the image frame of reference (i.e. image coordinate system) is transformed to the catheter coordinate system/patient coordinate system based on the relative three-dimensional pose (See [0069]) therebetween, the one or more processors are further configured to transform the third two-dimensional image and the reference marker into a three-dimensional coordinate space (i.e. corresponding to the patient coordinate system/space).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zhao such that the one or more processors are further configured to capture a third two-dimensional image, receive a user selection of a reference marker on the third two-dimensional image and transform the third two-dimensional image and the reference marker into a three-dimensional coordinate space in order to 1) to effectively construct the three-dimensional image with multiple images indicative of different characteristics of the target structure; 2) establish/define the position of the target structure such that an interventional instrument (i.e. 310 in FIG. 4, for example) can be guided thereto (see Zhao: [0053]) and 3) allow for greater accuracy in biopsy or other focal therapies directed to nodules with small diameters (e.g., approximately 10 mm or smaller) (see Zhao: [0066]).
Regarding claim 62, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, and Zhao further teaches “wherein the tool channel terminates in the distal portion of the elongate flexible instrument” (See FIG. 2 and “The catheter system 202 includes an elongated flexible body 216 having a proximal end 217 and a distal end 218. A channel 219 extends within the flexible body 216” [0037] and “The tool 228 may be advanced from the opening of the channel 219 to perform the procedure and then retracted back into the channel when the procedure is complete” [0049]. Therefore, the tool 228 may be advanced through the channel 219. As shown in FIG. 2, the channel 219 terminates in the distal portion (i.e. 218) of the elongate flexible instrument. Therefore, the tool channel terminates in the distal portion of the elongate flexible instrument.
Claim(s) 3-5, and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. US 2020/0214664 A1 “Zhao” and Hunter et al. US 2022/0375114 A1 “Hunter” as applied to claim 2 above, and further in view of Barbagli et al. US 2008/0119727 A1 “Barbagli”.
Regarding claim 3, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 2 above. Although Zhao includes “an ultrasound imaging device” (see [0066] as discussed in claim 2 above), the combination does not explicitly teach “wherein the ultrasound imaging device includes an imaging array of ultrasound transducers”.
Barbagli is within the same field of endeavor as the claimed invention because it involves an ultrasound imaging catheter (see FIG. 4B).
Barbagli teaches “wherein the ultrasound imaging device includes an imaging array of ultrasound transducers” (“The depicted assembly (4000) also comprises an ultrasound imaging catheter (414) comprising an ultrasound transducer (416). […] The ultrasound transducers (416) depicted in FIGS. 4B and 4C preferably are linear array or phased array type ultrasound transducers, and ultrasound catheters comprising such transducers are available from manufacturers such as the Acuson division of Siemens under the trade name "AcuNav", for example” [0044]. Therefore, the ultrasound imaging device includes an imaging array of ultrasound transducers (i.e. linear array or phased array type ultrasound transducers).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that it includes an imaging array of ultrasound transducers as discussed in Barbagli in order to facilitate imaging within a patient’s body. A linear array and a phased array of ultrasound transducers, are two of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the linear array or phased array (i.e. 416) of ultrasound transducers of Barbagli into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body.
Regarding claim 4, Zhao in view of Hunter and Barbagli discloses all features of the claimed invention as discussed with respect to claim 3 above, and Barbagli further teaches “wherein the imaging array extends along the side wall of the elongate flexible instrument” (“The depicted guide instrument (412) is movably positioned within the working lumen of a sheath instrument (410) to enable relative insertion of the two instruments (412, 410), relative rotation, or "roll" of the two instruments (412, 410), and relative steering or bending of the two instruments (412, 410) relative to each other, particularly when a distal portion of the guide instrument (412) is inserted beyond the distal tip of the sheath instrument (410). […] The depicted assembly (4000) also comprises an ultrasound imaging catheter (414) comprising an ultrasound transducer (416)” [0044]. As shown in FIG. 4B, the imaging array (i.e. 416) extends along a side wall of the elongate flexible instrument (i.e. sheath instrument 410/guide instrument 412). Thus, the imaging array extends along the side wall of the elongate flexible instrument.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that it includes an imaging array which extends along the side wall of the elongate flexible instrument as discussed in Barbagli in order to facilitate imaging within a patient’s body. An imaging array which extends along a side wall of the elongate flexible instrument is one of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the linear array or phased array (i.e. 416) of ultrasound transducers of Barbagli into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body.
Regarding claim 5, Zhao in view of Hunter and Barbagli discloses all features of the claimed invention as discussed with respect to claim 4 above, and Barbagli further teaches “wherein the imaging array comprises a linear phased array” (See [0044] as discussed in claim 3 above. Therefore, the imaging array comprises a linear phased array.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that it includes an imaging array of ultrasound transducers as discussed in Barbagli in order to facilitate imaging within a patient’s body. A linear array (i.e. linear phased array) ultrasound transducers, is one of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the linear array (i.e. linear phased array) (see 416 in FIG. 4B) of ultrasound transducers of Barbagli into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body.
Regarding claim 7, Zhao in view of Hunter and Barbagli discloses all features of the claimed invention as discussed with respect to claim 3 above, and Zhao further teaches “wherein the imaging […] is arranged on a distal end surface of the elongate flexible instrument” (“In other embodiments, a forward-looking ultrasound probe may be used to image tissue distal of the imaging transducer. The ultrasound probe may be relatively small to navigate narrow anatomical passageways. For example, the ultrasound probe may have distal end diameter of approximately 1.4 mm” [0066]. In a forward-looking ultrasound probe, the ultrasound transducer must be arranged on a distal end surface (i.e. tip) of the elongate flexible instrument such that is faces tissue distal of the imaging transducer. Therefore, the imaging device is arranged on a distal end surface of the elongate flexible instrument (i.e. 216 in FIG. 2A,
Barbagli teaches that the imaging device is an “imaging array” (See [0044] as discussed with respect to claim 3 above.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that the forward-looking ultrasound probe of Zhao includes an imaging array of ultrasound transducers as discussed in Barbagli in order to facilitate imaging within a patient’s body. A linear array and a phased array of ultrasound transducers, are two of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the linear array or phased array (i.e. 416) of ultrasound transducers of Barbagli into the ultrasound imaging device (i.e. the forward-looking ultrasound probe) of Zhao would yield the predictable result of facilitating imaging within a patient’s body.
Regarding claim 8, Zhao in view of Hunter and Barbagli discloses all features of the claimed invention as discussed with respect to claim 7 above, and Barbagli further teaches “wherein the imaging array comprises a linear phased array” (See [0044] as discussed in claim 3 above. Therefore, the imaging array comprises a linear phased array.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that it includes an imaging array of ultrasound transducers in the form of a linear phased array as discussed in Barbagli in order to facilitate imaging within a patient’s body. A linear array (i.e. linear phased array) ultrasound transducers, is one of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the linear array (i.e. linear phased array) (see 416 in FIG. 4B) of ultrasound transducers of Barbagli into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body.
Regarding claim 9, Zhao in view of Hunter and Barbagli discloses all features of the claimed invention as discussed with respect to claim 7 above, and Barbagli further teaches “wherein the imaging array comprises an annular array” (“FIG. 4D depicts another variation similar to that of FIG. 4b, with the exception that the ultrasound catheter (414) comprises a set of circumferential ultrasound transducers (418) which may be selectively activated to enable perimetric image capture without as much roll activity as would be required by a more conventional linear or phased array transducer to capture an image of tissue or structures surrounding the entire perimeter of the ultrasound catheter (i.e., a conventional linear or phased array transducer would need to be rolled by about approximately 360 degrees to capture images about the entire perimeter, while a circumferential transducer set may be sequentially or simultaneously activated to capture a similar set of images about the perimeter). Catheters comprising circumferential transducer sets such as that depicted in FIG. 4D are available from suppliers such as Volcano Therapeutics, Inc.” [0045]. In this case, the circumferential ultrasound transducers 418 are positioned around the perimeter of the ultrasound imaging catheter 414 (see FIG. 4D). Therefore, the circumferential ultrasound transducer 418 represents an annular array.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that it includes an imaging array of ultrasound transducers in the form of an annular array (i.e. see 418 in FIG. 4D) as discussed in Barbagli in order to facilitate imaging within a patient’s body without as much roll activity as would be required by a more conventional linear or phased array transducer to capture an image of tissue or structures surrounding the entire perimeter of the ultrasound catheter (See Barbagli: [0045]). An annular array (i.e. circumferential transducer, 418 in FIG. 4D) of ultrasound transducers, is one of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the annular array (see 418 in FIG. 4D) of ultrasound transducers of Barbagli into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body with less roll activity than a conventional linear or phased array transducer.
Regarding claim 10, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 2 above, however, the combination does not teach “wherein the ultrasound imaging device includes a radial transducer”.
Barbagli teaches “wherein the ultrasound imaging device includes a radial transducer” (See [0045] as discussed in claim 9 above. Therefore, the ultrasound imaging device (i.e. circumferential ultrasound transducer 418) includes a radial (i.e. circumferential) transducer.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound imaging device of Zhao such that it includes a radial transducer (i.e. see 418 in FIG. 4D) as discussed in Barbagli in order to facilitate imaging within a patient’s body without as much roll activity as would be required by a more conventional linear or phased array transducer to capture an image of tissue or structures surrounding the entire perimeter of the ultrasound catheter (See Barbagli: [0045]). An annular array (i.e. circumferential transducer, 418 in FIG. 4D) of ultrasound transducers, is one of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the annular array (see 418 in FIG. 4D) of ultrasound transducers of Barbagli into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body with less roll activity than a conventional linear or phased array transducer.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. US 2020/0214664 A1 “Zhao”, Hunter et al. US 2022/0375114 A1 “Hunter” and Barbagli et al. US 2008/0119727 A1 “Barbagli” as applied to claim 4 above, and further in view of Lee et al. US 2007/0167824 A1 “Lee”.
Regarding claim 6, Zhao in view of Hunter and Barbagli discloses all features of the claimed invention as discussed with respect to claim 4 above. Although Barbagli discloses “The ultrasound transducers (416) depicted in FIGS. 4B and 4C preferably are linear array or phased array type ultrasound transducers, and ultrasound catheters comprising such transducers are available from manufacturers such as the Acuson division of Siemens under the trade name "AcuNav", for example” [0044], Barbagli does not explicitly teach “wherein the imaging array comprises a curved phased array”.
Lee is within the same field of endeavor as the claimed invention because it involves utilizing a catheter with an ultrasound transducer assembly 100 (See Lee: [0089]).
Lee teaches “wherein the imaging array comprises a curved phased array” (“The ultrasound transducer assembly 100 comprises a transducer array 110. This may be a phased array, which may include a flat phased array, a curved array, or a phased sector array, or other types of arrays as is appropriate for the application, such as, but not limited to, a linear sequential array, a multi-row array, and other 1D and 2D arrays” [0089]. Therefore, the phased array may include a curved phased array.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging array of Zhao in view of Barbagli such that the imaging array comprises a curved phased array as disclosed in Lee in order to facilitate imaging within a patient’s body. A curved phased array of ultrasound transducers, is one of a finite number of configurations which can be used to obtain ultrasound images from within a patient’s body with a reasonable expectation of success. Thus, substituting the curved phased array of ultrasound transducers of Lee into the ultrasound imaging device of Zhao would yield the predictable result of facilitating imaging within a patient’s body.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. US 2020/0214664 A1 “Zhao” and Hunter et al. US 2022/0375114 A1 “Hunter” as applied to claim 1 above, and further in view of Holsing et al. US 2013/0225943 A1 “Holsing”.
Regarding claim 14, Zhao in view of Hunter discloses all features of the claimed invention as discussed with respect to claim 1 above, although Zhao discloses “The tool 228 may be advanced from the opening of the channel 219 to perform the procedure and then retracted back into the channel when the procedure is complete. The interventional tool 228 may be removed from the proximal end 217 of the catheter flexible body or from another optional instrument port (not shown) along the flexible body” [0049], however Zhao does not teach “wherein the tool channel (i.e. 219) terminates at a location on the side wall proximal of a distal end face of the elongate flexible instrument”.
Holsing is within the same field of endeavor as the claimed invention because it involves a surgical instrument navigation system with a biopsy device which exits from a side of an elongate catheter body (see [Abstract], [0189]).
Holsing teaches “wherein the tool channel terminates at a location on the side wall proximal of a distal end face of the elongate flexible instrument” (“In yet another embodiment, biopsy device 220 is extendable is extendable along a path from a position within the outer wall 236 through a side exit to a position outside the outer wall 236 at an angle of at least 30 degrees relative to the longitudinal axis, wherein the path of biopsy device 220 can be calibrated to the location of an electromagnetic localization sensor positioned at the distal end portion of the elongate flexible shaft and displayed by a surgical instrument navigation system. Various embodiments of biopsy devices exiting from the side of the elongate catheter body can be seen in FIG. 37” [0189]; “As illustrated in FIG. 37, medical instrument 108 may comprise a variety of biopsy devices at the end 140 of medical instrument 108, including, but not limited to, for example, a forceps device 37A, an auger device 37D, a boring bit device 37B, and a brush device 37C” [0200]; “Referring now to FIG. 39, another embodiment of the side exiting catheter is shown wherein a side exiting tip component 101 is at distal end portion 134 of elongate flexible shaft 130 […] In this embodiment, medical instrument 108 extends through channel 106 of side exiting tip component 101 and channel 107 of elongate flexible shaft 130” [0202].
As shown in FIGS. 37 and 39, the medical instrument 108 extends through the side exit (i.e. side exit 105 in connection with channel 106) of the elongate flexible shaft 130, the side exit terminating at a location of the side wall proximal of a distal end face (i.e. tip) of the elongate flexible instrument (i.e. 130). Therefore, the tool channel terminates at a location on the side wall proximal of a distal end face of the elongate flexible instrument.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tool channel of Zhao such that it terminates at a location on the side wall proximal of a distal end face of the elongate flexible instrument as disclosed in Holsing in order to allow user to position a tool to easily gain access to, manipulate, remove, or otherwise treat tissue within the body (see Holsing: [0193]). A side exiting catheter, such as the ones shown in FIGS. 37 and 39 of Holsing, is one of a finite number of devices which can be used to perform a medical procedure within a patient’s body while also tracking a location of a surgical instrument (i.e. 108 in Holsing: FIGS. 37 and 39) via one or more localization elements 24 (see Holsing: [0076]) with a reasonable expectation of success. Thus, modifying the tool channel of Zhao such that it terminates at a location on the side wall proximal of a distal end face of the elongate flexible instrument as disclosed in Holsing would yield the predictable result of allowing a user to easily gain access to, manipulate, remove, or otherwise treat tissue within the body while also tracking the location thereof (i.e. via localization elements 24 of Holsing, for example).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797