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 09/02/2026. Claims 1-2, 5, 7-9, 11-14, 16, 18-20, and 22-24 are pending. Claims 3-4, 6, 10, 15, 17, 21 and 25-62 have been cancelled. Claims 1, 5, 7-9, 11 and 13 are newly amended. Claims 1-2, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24 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. Claim 13 is allowable for the reasons stated in the Allowable Subject Matter section below.
Response to Arguments
Applicant’s arguments, see Remarks pages 7-8, filed 09/02/2026, with respect to the objections to the drawings, specification and claims have been fully considered and are persuasive. The objections to the drawings, specification and claims in the non-final rejection of 06/04/2026 have been withdrawn.
Applicant’s arguments, see Remarks pages 8-11, filed 09/02/2026, with respect to the rejection of the claims under 35 U.S.C. 102 have been fully considered and are persuasive.
Regarding claim 1, the claim has been amended to recite: “performing an analysis of the anatomic model to facilitate selection of a plurality of nodal sites for analysis, wherein performing the analysis includes identifying a plurality of lymph nodes in the anatomic model; displaying, on a graphical user interface, an image of the anatomic model and an image of a lymph node of the plurality of lymph nodes; highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node”.
When rejecting previously pending claim 6, the Office Action cites to Kopel's paragraph [0072] as disclosing the "highlighting the image of the segmented lymph node if a staging threshold is met" recited in previously pending claim 6.
Amended claim 1 now recites "highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node."
As discussed during the interview, Applicant respectfully submits that Kopel's highlighting in paragraph [0072] is not "based on a measurable characteristic of the lymph node," as recited by amended claim 1. Rather, Kopel's highlighting is based on whether targets have been imaged by the EBUS instrument. For example, cited paragraph [0072] of Kopel states that "the additional targets may be highlighted and/or displayed with a different characteristic, such as a different color, than targets that have already been imaged."
For at least these reasons, Kopel does not disclose amended claim 1. Accordingly, amended claim 1 is allowable over Kopel.
The examiner respectfully acknowledges that paragraph [0072] of Kopel states that “the additional targets may be highlighted and/or displayed with a different characteristic, such as a different color, than targets that have already been imaged”. Therefore, the examiner agrees that Kopel does not teach that highlighting is performed “based on a measurable characteristic of the lymph node” as recited in amended claim 1. Rather, Kopel’s highlighting is based on whether targets have been imaged by the EBUS instrument.
Therefore, the rejection of claim 1 under 35 U.S.C. 102 in the non-final rejection of 06/04/2026 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Periaswamy et al. US 2008/0298662 A1 “Periaswamy” as discussed in the 35 U.S.C. 103 section below.
Regarding claim 13, the claim has been amended to recite: […] providing navigational guidance to direct a medical instrument to a nodal site of the plurality of nodal sites in the procedure sequence, wherein the navigational guidance includes an image of the anatomic model and a representation of a navigable path through the procedure sequence for the plurality of nodal sites, wherein the representation of the navigable path includes a first line segment extending between at least two of the plurality of nodal sites and indicating a portion of the navigable path that has been reached by the medical instrument and a second line segment extending between at least two of the plurality of nodal sites and indicating a portion of the navigable path that has not been reached by the medical instrument, and wherein the first line segment is visually distinguishable from the second line segment;”
When rejecting previously pending claim 13, the Office Action cites to the highlighting in Kopel's paragraph [0072] as disclosing the "wherein the representation of the navigable path includes a first portion indicating a portion of the navigable path that has been reached by the medical instrument and a second portion indicating a portion of the navigable path that has not been reached by the medical instrument and wherein the first portion is visually distinguishable from the second portion" recited in previously pending claim 13.
Amended claim 13 now recites, among other things, that the representation of the navigable path includes "a first line segment extending between at least two of the plurality of nodal sites and indicating a portion of the navigable path that has been reached by the medical instrument and a second line segment extending between at least two of the plurality of nodal sites and indicating a portion of the navigable path that has not been reached by the medical instrument, and wherein the first line segment is visually distinguishable from the second line segment."
As discussed during the interview, Applicant respectfully submits that Kopel's paragraph [0072] disclosure relates to coloring individual target nodes differently based on their imaging status. The individual target nodes are not a "line segment" and do not "extend[] between at least two of the plurality of nodal sites." As such, paragraph [0072] does not disclose a representation of a navigable path including first and second line segments each extending between at least two of the plurality of nodal sites "wherein the first line segment is visually distinguishable from the second line segment," as recited by amended claim 13.
For at least these reasons, Kopel does not disclose amended claim 13. Accordingly, amended claim 13 is allowable over Kopel.
The examiner agrees that Kopel’s paragraph [0072] disclosure is related to coloring individual target nodes differently based on their imaging status. The individual target nodes are not a “line segments” and do not “extend between at least two of the plurality of nodal sites”. Thus, the examiner acknowledges that paragraph [0072] does not disclose a representation of a navigable path including first and second line segments each extending between at least two of the plurality of nodal sites “wherein the first line segment is visually distinguishable from the second line segment” as recited in amended claim 13.
Therefore, the rejection of claim 13 under 35 U.S.C. 102 in the non-final rejection of 06/04/2026 has been withdrawn. The examiner respectfully refers the Applicant to the Allowable Subject Matter section below.
Regarding claims 2, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24, the examiner notes that these claims depend from claim 1, respectively. Therefore, these claims are subject to the reasoning provided therein. Thus, these claims are subject to the new ground(s) of rejection made in view of Periaswamy et al. US 2008/0298662 A1 “Periaswamy” as discussed in the 35 U.S.C. 103 section below.
Regarding claims 3-4 and 6, since these claims have been canceled herein, the rejections of these claims are rendered moot and are therefore withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-2, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, as written it reads “highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node”. However, there is a lack of written description for the staging threshold being “based on a measurable characteristic of the lymph node” or what the measurable characteristic includes. Thus, there is a lack of written description regarding this limitation and claim 1 is rejected under 35 U.S.C 112(a).
Regarding claims 2, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24, due to their dependence on claim 1, either directly or indirectly, these claims are subject to the reasoning provided therein. Thus, they inherit the rejection made under 35 U.S.C. 112(a).
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.
Claims 1-2, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24 are 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.
Regarding claim 1, as written it reads “highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node”. However, it is unclear what the scope of “measurable characteristics” is within the claim. When stated this way, measurable characteristics could be one or more of the following: diameter, size, shape, length, risk/malignancy level, brightness, and the like. The examiner recommends clarifying the scope of the term “measurable characteristics” as it relates to claim 1. Therefore, the claim is rejected under 35 U.S.C. 112(b).
Regarding claims 2, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24, due to their dependence on claim 1, either directly or indirectly, these claims are subject to the reasoning provided therein. Thus, they inherit the rejection made under 35 U.S.C. 112(b).
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, 5, 7-9, 11-12, 14, 16, 18-20, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable by Kopel et al. US 2019/0247127 A1 “Kopel” and further in view of Periaswamy et al. US 2008/0298662 A1 “Periaswamy”.
Regarding claim 1, Kopel teaches “A system for providing navigational guidance for a medical procedure, the system comprising:” (“FIG. 1 shows an electromagnetic navigation (EMN) system 100 suitable for implementing methods for performing endobronchial diagnostic and/or treatment procedures in an area of a patient's chest in accordance with this disclosure” [0041]. Therefore, FIG. 1 shows a system for providing navigational guidance (i.e. electromagnetic navigation) for a medical procedure (i.e. endobronchial diagnostic and/or treatment procedures.);
“a processor” (“FIG. 2 shows a simplified block diagram of computing device 80. Computing device 80 may include a memory 202, a processor 204, a display 206, a network interface 208, an input device 210, and/or an output module 212. Memory 202 may store the application 81 and/or image data 214. The application 81 may, when executed by the processor 204, cause the display 206 to present a graphical user interface (GUI) based on GUI instructions 216” [0051]. As shown in FIG. 1, the electromagnetic navigation (EMN) system 100 includes the computing device 80, the computing device 80 including the components shown in FIG. 2. Therefore, the system includes a processor.); and
“a memory operably coupled to the processor and storing instructions that, when executed by the processor, cause the system to perform operations comprising:” (See memory 202 as discussed in [0051] above. Therefore, the system includes a memory operably coupled to the processor and storing instructions (i.e. application 81) that when executed by the processor, cause the system to perform specific operations.);
“receiving an anatomic model of an anatomic region” (“Starting at step S302, the computing device 80 receives first image data [of] a surgical site. As noted above, the surgical site includes at least a portion of the patient's body. For illustrative purposes, the description below will use the patient's lungs as the surgical site. In some embodiments, the first image data may include image data from multiple pre-operative scans” [0056]; “Next, at step S304, the computing device 80 processes the first image data to identify one or more structures in the first image data. For example, the computing device 80 may identify the patient's lungs, and particularly, the bronchial network of the patient's airways in the first image data. The computing device 80 may further identify one or more lumens of the patient's vascular system, one or more lymph nodes and/or ducts of the patient's lymphatic system, other organs, markers, and/or one or more cysts or lesions or other aberrant structures in the first image data, as well as the pleural surfaces and/or fissures of the patient's lungs” [0057]; “Thereafter, at step S306, application 81 generates a three-dimensional (3D) model of the surgical site. The 3D model includes graphical representations of the surgical site, such as the patient's lungs, showing the locations of the lumens and structures of the bronchial, vascular, and lymphatic trees, as well as the pleural surfaces and fissures of the patient's lungs, markers, and/or lesions or other aberrant structures that may be present in the patient's lungs, as was identified in step S304. Next, at step S308, the computing device 80 labels one or more of the structures identified at step S304 in the model generated at step S306. In embodiments, the computing device 80 may label one or more lymph nodes based on a predetermined naming scheme or convention, such as based on the International Association for the Study of Lung Cancer's (IASLC) lymph node map” [0058]. Therefore, since the computing device 80 receives first image data of a surgical site, such as a patient’s lungs, processed the first image data to identify one or more structures in the first image data (i.e. including one or more lymph nodes), and generates a 3D model of the surgical site, the method carried out by the system involves receiving an anatomic model of an anatomic region (i.e. patient’s lungs).);
“performing an analysis of the anatomic model to facilitate selection of a plurality of nodal sites for analysis, wherein performing analysis includes identifying a plurality of lymph nodes in the anatomic model” (See [0057] and [0058] above and “Then, at step S310, a target is selected. The target may be selected from among the structures identified at step S304. The target may be automatically selected by the computing device 80, semi-automatically, and/or manually by the clinician providing input to the computing device 80, such as via input device 210. […] The clinician may also select one or more lesions and/or targets by viewing the first image data and/or the 3D model. […] In some embodiments, a plurality of targets are selected at step S310 and ordered in a list. For example, the computing device 80 may select a plurality of lymph nodes identified at step S304 as the targets” [0059]. In order for the computing device 80 to identify structures within the image data (i.e. received in step S302) in step S304 and subsequently generate a 3D model for a clinician (i.e. and/or computing device 80) to view/access when selecting one or more targets (i.e. corresponding to a plurality of lymph nodes, for example), the method carried out by the system must involve performing an analysis of the anatomic model to facilitate selection of a plurality of nodal sites for analysis, wherein performing the analysis includes identifying a plurality of lymph nodes in the anatomic model.);
“displaying, on a graphical user interface, an image of the anatomic model and an image of a lymph node of the plurality of lymph nodes” (See [0057] above and FIG. 3A. As shown in FIG. 3A, the planning phase 301 includes steps of generating a 3D model of the surgical site (i.e. 5306), labeling the structures on the 3D model (i.e. 5308), selecting a target (i.e. 5310) and determining a pathway to the target (i.e. 5312). Once these steps have been performed, the method exits the planning phase 301 and step 5314 is performed which involves displaying the target (i.e. lymph node, see [0057]) and the pathway on the 3D model. Therefore, the method involves displaying, on a graphical user interface, an image of the anatomic model and an image of a lymph node of the plurality of lymph nodes.).
[…]
“generating a procedure sequence for the plurality of nodal sites” (“After a target is selected, the computing device 80, at step S312, determines a pathway to the target. In embodiments, the computing device 80 determines a pathway via a luminal network, such as the patient's airways, from the target to the patient's trachea. […] In embodiments where multiple targets are selected, a plurality of pathways may be determined to visit each target. Additionally, the computing device 80 may automatically, or with input from the clinician, generate a diagnosis and/or treatment plan based on the identified structures, the selected targets, and/or the pathway” [0060]. Therefore, since the computing device 80 determines a plurality of pathways when multiple targets (i.e. corresponding to lymph nodes identified in step S304 and selected in step S310) are selected, the method carried out by the system involves generating a procedure sequence for the plurality of nodal sites.);
“providing navigational guidance to direct a medical instrument to a nodal site of the plurality of nodal sites in the procedure sequence” (“Following step S312, a navigation phase, as described above, may commence. Those of skill in the art will recognize that the planning phase may occur as a separate action from the navigation phase (e.g., at some date or time prior to the actual procedure). The navigation phase may include the endobronchial navigation of the LG 92 and/or the EBUS 62 of the system 100 to the target selected at step S310 via the pathway determined at step S312. As an initial step of the navigation phase a navigation plan is selected and loaded for display of the target and the pathway on the 3D model at step S314. In embodiments, the computing device 80 may cause a display device, such as display 206, to display the 3D model with the target and the pathway indicated thereon” [0061]. In this case, the LG 92 is a locatable guide (see [0042]) and the EBUS 62 is an endobronchial ultrasound tool (see [0045]). Therefore, since the navigation phase includes endobronchial navigation of the LG 92 and/or the EBUS 62 to the target selected at step S310 (see [0059]) along the pathway determined at step S312 (see [0060]), the method carried out by the system involves providing navigational guidance to direct a medical instrument (i.e. LG 92 and/or EBUS 62) to a nodal site of the plurality of nodal sites in the procedure sequence.); and
“gathering local image data from the medical instrument at the nodal site” (“At step S328, the computing device 80 provides guidance for positioning the LG 92 and/or EBUS 62 relative to the target. For example, the computing device 80 may cause the display 206 to display visual guidance for positing the LG 92 and/or EBUS 62 relative to the target. […] The computing device 80 then, at step S330, determines whether the LG 92 and/or EBUS 62 are correctly positioned relative to the target […] Alternatively, if the computing device 80 determines that the LG 92 and/or EBUS 62 are correctly positioned relative to the target (“YES” at step S330), processing proceeds to step S332” [0066]; “At step S332, the computing device 80 receives ultrasound image data of the target. The ultrasound image data may be captured by the EBUS 62 and may be provided to the computing device 80 via an ultrasound workstation and/or a direct connection between the EBUS 62 and the computing device 80” [0067]. Therefore, since the computing device 80 receives ultrasound image data of the target via the EBUS 62 once it has been positioned correctly relative to the target, the method carried out by the system involves gathering local image data (i.e. ultrasound image data) from the medical instrument (i.e. EBUS 62) at the nodal site (i.e. target/lymph node selected in step S310).).
However, Kopel does not teach “highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node”.
Periaswamy is within the same field of endeavor as the claimed invention because it involves a method for detecting lymph nodes in a medical image (see [Abstract]).
Periaswamy teaches “highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node” (“As discussed above, examples of parameters that may be used to identify lymph nodes include intensity of the lymph node candidate, size of the lymph node candidate, sphericity of the lymph node candidate and other shape descriptors” [0043]; “According to an exemplary embodiment of the present invention, one or more slider bars may be illustrated in conjunction with the medical image. Detected lymph nodes may be highlighted or otherwise identified within the medical image data. There may be one or more slider bars for each user-adjustable parameter. For example, there may be a first slider bar indicating minimum size and a second slider bar indicating maximum size. There may also be a third slider bar for minimum sphericity and a fourth slider bar for maximum sphericity. The user may then adjust slider bars, for example, using a pointing device such as a mouse, to change one or more parameters. For example, the user may lower the minimum size parameter to broaden what is considered to be a lymph node. As this parameter is changed, additional locations may light up as identified lymph nodes. The user may increase the minimum sphericity to narrow what is considered to be a lymph node. As this parameter is changed, locations previously highlighted as identified lymph nodes may be un-highlighted” [0045].
Therefore, since the user can adjust slider bars indicating minimum size, maximum size, minimum sphericity and maximum sphericity, respectively, and the detected lymph nodes are highlighted or un-highlighted based on the user’s adjustment, the method carried out by the system of Periaswamy involves highlighting the image of the lymph node (see FIG. 2, for example) if a staging threshold (i.e. corresponding to the position of the sliders) is met, wherein the staging threshold is based on a measurable characteristic of the lymph node (i.e. size, sphericity).).
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 Kopel such that the processor performs the operation of highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node as discussed in Periaswamy in order to allow a user to have more control over selecting the parameters used in identifying lymph nodes within the image. Adjusting slider bars on a graphical user interface which correspond to the minimum size, maximum size, minimum sphericity and maximum sphericity is one of a finite number of techniques which can be used to select the characteristics of lymph nodes to be highlighted with a reasonable expectation of success. Thus, modifying the system of Kopel such that the processor performs the operation of highlighting the image of the lymph node if a staging threshold is met, wherein the staging threshold is based on a measurable characteristic of the lymph node as discussed in Periaswamy would yield the predictable result of allowing a user to have more control over selecting the parameters used in identifying/highlighting lymph nodes within the image.
Regarding claim 2, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein performing the analysis includes identifying a plurality of anatomic stations for the anatomic model” (See [0057] and [0058] as discussed in claim 1 above. Therefore, since the computing device 80 may identify one or more lumens of the patient’s vascular system, one or more lymph nodes and/or ducts of the patient’s lymphatic system, other organs, markers, and/or one or more cysts or lesions or other aberrant structures in the first image data, as well as the pleural surfaces and/or fissures of the patient’s lungs and label the structures on the 3D model (see step S308, in [0058]), the step of performing the analysis includes identifying a plurality of anatomic stations (i.e. lumens, lymph nodes, etc.) for the anatomic model (i.e. 3D model of patient’s lungs).).
Regarding claim 5, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the image of the lymph node is overlayed on an image of an anatomic station of the anatomic model” (See [0059] and [0060] as discussed in claim 1 above and “At step S370, the computing device 80 displays a view of the 3D rendering showing the position of the treatment tool relative to the target. In embodiments, the computing device 80 may cause the display 206 to display a view of the 3D rendering showing the pose of the treatment tool relative to the target and any interaction between the treatment tool and the target. For example, as shown in FIG. 5, a view of the 3D model may be displayed showing the pose of an EBUS 508 relative to a target 516, and interaction between a biopsy needle 512 and the target 516” [0076] and “Ultrasound images 514 captured by the ultrasound sensor are shown overlaid onto the 3D model, with a 3D rendering of the target 516 displayed thereon” [0083]. As shown in FIG. 5, the ultrasound images 514 is overlaid onto the 3D model. Therefore, the image of the lymph node (i.e. target 516) is overlayed on an image of an anatomic station of the anatomic model (i.e. 3D model).).
Regarding claim 7, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 4 above, and Kopel further teaches “wherein the performed operations further comprise overlaying positron emission tomography (PET) imaging information on the image of the anatomic model” (“The computing device 80 includes hardware and/or software, such as an application 81, used to facilitate the various phases of an EMN procedure, as described further below. For example, computing device 80 utilizes radiographic image data acquired from a CT scan, cone beam computed tomography (CBCT) scan, magnetic resonance imaging (MRI) scan, positron emission tomography (PET) scan, X-ray scan, and/or any other suitable imaging modality to generate and display a 3D model of the patient's airways, identify a target on the radiographic image data and/or 3D model (automatically, semi-automatically or manually), and allow for the determination and selection of a pathway through the patient's airways to the target” [0046]; “For example, the first image data may include image data from a CT scan, a CBCT scan, a MRI scan, a PET scan, an X-ray scan, etc.” [0056]; “FIG. 6 shows yet another illustrative GUI that may be displayed during various steps of the method 300. Similar to FIGS. 4 and 5, FIG. 6 also shows a view of the 3D model including the patient's trachea 602 and airway tree 604, along with the positions of a plurality of lymph nodes 606 displayed thereon. […] Additional details, such as anatomical features or characteristics, regarding the selected lymph node 608 may be displayed in a view 610. The additional details may include a PET uptake, a size, etc. Additional structures, such as one or more lesions 612 may also be displayed on the view of the 3D model” [0084]. Therefore, since the computing device 80 can utilize radiographic image data acquired from a PET scan to generate and display a 3D model of the patient’s airways, and the GUI may display additional details regarding the selected lymph node 608, such as PET uptake, the performed operations further comprise overlaying positron emission tomography (PET) imaging information (i.e. PET image data or PET uptake) on the image of the anatomical model (i.e. 3D model, see FIG. 6, for example).).
Regarding claim 8, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the navigational guidance includes a displayed list view of the plurality of lymph nodes grouped by a plurality of anatomic stations for the anatomic model” (“FIG. 7 shows another view of the GUI of FIG. 6 showing additional features and/or details that may be displayed during various steps of the method 300. […] Additionally, FIG. 7 may show a list 722 of lymph nodes for which treatment is required” [0085]. As shown in FIG. 7, a list 722 of lymph nodes is displayed, where each of the lymph nodes (i.e. 4R, 7, 4L, 10L and 11L) are located at different positions (i.e. anatomic stations) in the center/center left portion of the model. Therefore, the navigational guidance includes a displayed list view of the plurality of lymph nodes grouped by a plurality of anatomic stations for the anatomic model.).
Regarding claim 9, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 8 above, and Kopel further teaches “wherein the displayed list view includes a size or a shape for at least one of the plurality of lymph nodes” (See [0085] as discussed in claim 8 above and FIGS. 7 and 8. As shown in FIG. 7, the PET uptake, Size on CT, Size on U/S and U/S Features are displayed for lymph node 10L. Additionally, FIG. 8 shows the PET uptake, Size on CT, Size on U/S and U/S Features are displayed for lymph node 4L. Therefore, the list view includes a size or a shape for at least one of the plurality of lymph nodes.).
Regarding claim 11, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the performed operations further comprise displaying critical anatomy near at least one of the plurality of nodal sites” (See [0084] as discussed in claim 7 above. As shown in FIG. 6, for example, the lymph nodes 606 are present at various positions along the patient’s trachea 602 and airway tree 604. Therefore, since the 3D model shows the patient’s trachea 602 and airway tree 604 with the lymph nodes displayed throughout, the performed operations further comprise displaying critical anatomy (i.e. trachea, airway tree) near at least one of the plurality of nodal sites (i.e. lymph nodes).).
Regarding claim 12, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the navigational guidance includes an image of the anatomic model and a representation of a navigable path through the procedure sequence for the plurality of nodal sites” (See [0060] and [0061] as discussed in claim 1 above. Therefore, since the computing device 80 causes a display device to display the 3D model with the target and the pathway indicated thereon (see [0061]) and a plurality of pathways are determined to visit each target (i.e. lymph node, see [0060]), the navigational guidance includes an image of the anatomical model and a representation of a navigable path through the procedure sequence for the plurality of nodal sites.).
Regarding claim 14, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 12 above, and Kopel further teaches “wherein the navigational guidance further includes a displayed representation of critical anatomy along the navigable path or displayed nodal markers adjacent to one or more of the plurality of nodal sites” (See [0084] and FIG. 6 as discussed in claim 7 above. As shown in FIG. 6, the patient’s trachea 602 and airway tree 604 are displayed along with the plurality of lymph nodes 606. Therefore, the navigational guidance further includes a displayed representation of critical anatomy along the navigable path or displayed nodal markers (i.e. ovals/circles shown in FIGS. 4-6, for example) adjacent to one or more of the plurality of nodal sites.).
Regarding claim 16, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the navigational guidance includes an indicator configured to indicate that at least one nodal site of the plurality of nodal sites has or has not been sampled by the medical instrument” (See [0072] as discussed in claim 13 above. Furthermore, as shown in FIG. 8, the box on the right includes check marks next to lymph nodes 4R and 7, thus indicating that these targets have been imaged by the EBUS 62 already. Therefore, since additional targets may be highlighted and/or displayed with a different characteristic, such as a different color, than targets that have already been imaged or a check mark can be displayed (see FIG. 8), the navigational guidance includes an indicator (i.e. color or check mark) configured to indicate that at least one nodal site (i.e. lymph node) of the plurality of nodal sites has or has not been sampled by the medical instrument.).
Regarding claim 18, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the navigational guidance includes an indicator configured to indicate a nodal site of the plurality of nodal sites to be sampled by the medical instrument” (See [0072] as discussed in claim 13 above. Furthermore, as shown in FIG. 8, the box on the right includes check marks next to lymph nodes 4R and 7, thus indicating that these targets have been imaged by the EBUS 62 already. Therefore, lymph nodes 4L, 10L and 11L have not been imaged by the EBUS 62. Therefore, since additional targets may be highlighted and/or displayed with a different characteristic, such as a different color, than targets that have already been imaged or a check mark can be displayed indicating which lymph nodes have been imaged already (i.e. lymph nodes without a check having not been imaged yet, see FIG. 8), the navigational guidance includes an indicator (i.e. color or check mark) configured to indicate that at least one nodal site (i.e. lymph node) of the plurality of nodal sites to be sampled by the medical instrument.).
Regarding claim 19, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 18 above, and Kopel further teaches “wherein the indicator is displayed with a three-dimensional image of the anatomic model” (See [0072] as discussed in claim 13, FIG. 8 and “FIG. 6 is a view of yet another illustrative graphical user interface showing a 3D model of at least a portion of the patient's chest which may be displayed by the computing device of FIG. 2 during performance of the method of FIGS. 3A-3D” [0031]; “FIG. 8 is yet another view of the graphical user interface of FIGS. 6 and 7 showing additional details that may be displayed by the computing device of FIG. 2 during performance of the method of FIGS. 3A-3D” [0033]. As shown in FIG. 8, the list with the check marks is displayed along with the 3D model of the patient’s lungs. Therefore, the indicator is displayed with a three-dimensional image of the anatomic model.).
Regarding claim 20, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 18 above, and Kopel further teaches “wherein the indicator is displayed with a virtual or a real-time endoscopic image view” (See [0086] as discussed with respect to claim 4 above. In this case, the view 830 represents a virtual endoscopic image view which is acquired by the EBUS 62. As shown in FIG. 8, the indicators (i.e. check marks on list) are displayed on the same GUI screen as the view 830. Therefore, the indicator is displayed with a virtual or a real-time endoscopic image view.).
Regarding claim 22, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein providing navigational guidance includes displaying a user interface orientation element including a direction indicator for an imaging element of the medical instrument and a representation of a critical anatomy” (“FIG. 5 shows another illustrative GUI that may be displayed during various steps of the method 300. As noted above, FIG. 5 shows a view of the 3D model including portions of the patient's bronchial tree 502, vascular tree 504, and lymph nodes 506. Also shown in FIG. 5 is a representation of the EBUS 508 including an ultrasound sensor 510 and a biopsy needle 512. FIG. 5 is a representation of the EBUS 508 including an ultrasound sensor 510 and a biopsy needle 512. Ultrasound images 514 captured by the ultrasound sensor are shown overlaid onto the 3D model, with a 3D rendering of the target 516 displayed thereon” [0083]. As shown in FIG. 5, the ultrasound sensor 510 is oriented toward the target 516. Therefore, the step of providing navigational guidance includes displaying a user interface orientation element including a direction indicator (i.e. corresponding to the location of the ultrasound sensor 510) for an imaging element (i.e. 510) of the medical instrument (i.e. EBUS 508) and a representation of a critical anatomy (i.e. bronchial tree 502, vascular tree 504).).
Regarding claim 23, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein providing navigational guidance includes displaying a representation of a field of view area of an imaging element of the medical instrument” (See [0086] as discussed with respect to claim 4 above. The view 830 represents a field of view area of an imaging element of medical instrument (i.e. EBUS 62). Thus, the step of providing navigational guidance includes displaying a representation of a field of view area of an imaging element of the medical instrument (i.e. EBUS 62).).
Regarding claim 24, Kopel in view of Periaswamy discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kopel further teaches “wherein the performed operations further comprise displaying the local image data with an image annotation of the local image data” (“FIG. 8 further shows a view 830 of the ultrasound image data captured by the EBUS 62, where the ultrasound image data is augmented with indicators 832 representing the positions of identified structures in the ultrasound image data” [0086]. As shown in FIG. 8, the indicators 832 (i.e. annotations indicating the borders of structures within the image) are presented on the view 830. In this case, the view 830, shown in FIG. 8, represents a local image of the lymph node (i.e. target) which is captured by the EBUS 62. Therefore, the performed operations further comprise displaying the local image data with an image annotation of the local image data (i.e. indicators 832).).
Allowable Subject Matter
Claim 13 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 13, Kopel (US 2019/0247127 A1) teaches “A system for providing navigational guidance for a medical procedure, the system comprising:” (“FIG. 1 shows an electromagnetic navigation (EMN) system 100 suitable for implementing methods for performing endobronchial diagnostic and/or treatment procedures in an area of a patient's chest in accordance with this disclosure” [0041]. Therefore, FIG. 1 shows a system for providing navigational guidance (i.e. electromagnetic navigation) for a medical procedure (i.e. endobronchial diagnostic and/or treatment procedures.);
“a processor” (“FIG. 2 shows a simplified block diagram of computing device 80. Computing device 80 may include a memory 202, a processor 204, a display 206, a network interface 208, an input device 210, and/or an output module 212. Memory 202 may store the application 81 and/or image data 214. The application 81 may, when executed by the processor 204, cause the display 206 to present a graphical user interface (GUI) based on GUI instructions 216” [0051]. As shown in FIG. 1, the electromagnetic navigation (EMN) system 100 includes the computing device 80, the computing device 80 including the components shown in FIG. 2. Therefore, the system includes a processor.); and
“a memory operably coupled to the processor and storing instructions that, when executed by the processor, cause the system to perform operations comprising:” (See memory 202 as discussed in [0051] above. Therefore, the system includes a memory operably coupled to the processor and storing instructions (i.e. application 81) that when executed by the processor, cause the system to perform specific operations.);
“receiving an anatomic model of an anatomic region” (“Starting at step S302, the computing device 80 receives first image data [of] a surgical site. As noted above, the surgical site includes at least a portion of the patient's body. For illustrative purposes, the description below will use the patient's lungs as the surgical site. In some embodiments, the first image data may include image data from multiple pre-operative scans” [0056]; “Next, at step S304, the computing device 80 processes the first image data to identify one or more structures in the first image data. For example, the computing device 80 may identify the patient's lungs, and particularly, the bronchial network of the patient's airways in the first image data. The computing device 80 may further identify one or more lumens of the patient's vascular system, one or more lymph nodes and/or ducts of the patient's lymphatic system, other organs, markers, and/or one or more cysts or lesions or other aberrant structures in the first image data, as well as the pleural surfaces and/or fissures of the patient's lungs” [0057]; “Thereafter, at step S306, application 81 generates a three-dimensional (3D) model of the surgical site. The 3D model includes graphical representations of the surgical site, such as the patient's lungs, showing the locations of the lumens and structures of the bronchial, vascular, and lymphatic trees, as well as the pleural surfaces and fissures of the patient's lungs, markers, and/or lesions or other aberrant structures that may be present in the patient's lungs, as was identified in step S304. Next, at step S308, the computing device 80 labels one or more of the structures identified at step S304 in the model generated at step S306. In embodiments, the computing device 80 may label one or more lymph nodes based on a predetermined naming scheme or convention, such as based on the International Association for the Study of Lung Cancer's (IASLC) lymph node map” [0058]. Therefore, since the computing device 80 receives first image data of a surgical site, such as a patient’s lungs, processed the first image data to identify one or more structures in the first image data (i.e. including one or more lymph nodes), and generates a 3D model of the surgical site, the method carried out by the system involves receiving an anatomic model of an anatomic region (i.e. patient’s lungs).);
“performing an analysis of the anatomic model to facilitate selection of a plurality of nodal sites for analysis” (See [0057] and [0058] above and “Then, at step S310, a target is selected. The target may be selected from among the structures identified at step S304. The target may be automatically selected by the computing device 80, semi-automatically, and/or manually by the clinician providing input to the computing device 80, such as via input device 210. […] The clinician may also select one or more lesions and/or targets by viewing the first image data and/or the 3D model. […] In some embodiments, a plurality of targets are selected at step S310 and ordered in a list. For example, the computing device 80 may select a plurality of lymph nodes identified at step S304 as the targets” [0059]. In order for the computing device 80 to identify structures within the image data (i.e. received in step S302) in step S304 and subsequently generate a 3D model for a clinician (i.e. and/or computing device 80) to view/access when selecting one or more targets (i.e. corresponding to a plurality of lymph nodes, for example), the method carried out by the system must involve performing an analysis of the anatomic model to facilitate selection of a plurality of nodal sites for analysis, wherein performing the analysis includes identifying a plurality of lymph nodes in the anatomic model.);
“generating a procedure sequence for the plurality of nodal sites” (“After a target is selected, the computing device 80, at step S312, determines a pathway to the target. In embodiments, the computing device 80 determines a pathway via a luminal network, such as the patient's airways, from the target to the patient's trachea. […] In embodiments where multiple targets are selected, a plurality of pathways may be determined to visit each target. Additionally, the computing device 80 may automatically, or with input from the clinician, generate a diagnosis and/or treatment plan based on the identified structures, the selected targets, and/or the pathway” [0060]. Therefore, since the computing device 80 determines a plurality of pathways when multiple targets (i.e. corresponding to lymph nodes identified in step S304 and selected in step S310) are selected, the method carried out by the system involves generating a procedure sequence for the plurality of nodal sites.);
“providing navigational guidance to direct a medical instrument to a nodal site of the plurality of nodal sites in the procedure sequence, wherein the navigational guidance includes an image of the anatomic model and a representation of a navigable path through the procedure sequence for the plurality of nodal sites” (“For example, the additional targets may be highlighted and/or displayed with a different characteristic, such as a different color, than targets that have already been imaged. In some embodiments, one or more regions of the 3D model may be displayed with a different characteristic, such as a different color, to indicate that there are additional targets to be imaged in those regions of the 3D model. Thereafter, at step S364, the computing device 80 selects (automatically, semi-automatically, or manually) a next target. The next target may be selected based on the predetermined diagnosis and/or treatment plan, based on its proximity to the previous target, based on its accessibility from the current position of the EBUS 62, etc. The computing device 80 then, at step S366, determines a pathway from the current position of the EBUS 62 to the next target. The computing device 80 may further cause the display 206 to display the pathway to the next target on the 3D model” [0072]. Therefore, the method carried out by the system involves providing navigational guidance to direct a medical instrument (i.e. endobronchial ultrasound tool, EBUS 62) to a nodal site of the plurality of nodal sites in the procedure sequence, wherein the navigational guidance includes an image of the anatomic model and a representation of a navigable path through the procedure sequence for the plurality of nodal sites (see step 5314 in FIG. 3A: display the target (i.e. lymph node) and the pathway on the 3D model).);
[…] and
“gathering local image data from the medical instrument at the nodal site” (“At step S328, the computing device 80 provides guidance for positioning the LG 92 and/or EBUS 62 relative to the target. For example, the computing device 80 may cause the display 206 to display visual guidance for positing the LG 92 and/or EBUS 62 relative to the target. […] The computing device 80 then, at step S330, determines whether the LG 92 and/or EBUS 62 are correctly positioned relative to the target […] Alternatively, if the computing device 80 determines that the LG 92 and/or EBUS 62 are correctly positioned relative to the target (“YES” at step S330), processing proceeds to step S332” [0066]; “At step S332, the computing device 80 receives ultrasound image data of the target. The ultrasound image data may be captured by the EBUS 62 and may be provided to the computing device 80 via an ultrasound workstation and/or a direct connection between the EBUS 62 and the computing device 80” [0067]. Therefore, since the computing device 80 receives ultrasound image data of the target via the EBUS 62 once it has been positioned correctly relative to the target, the method carried out by the system involves gathering local image data (i.e. ultrasound image data) from the medical instrument (i.e. EBUS 62) at the nodal site (i.e. target/lymph node selected in step S310).).
However, Kopel does not teach “wherein the representation of the navigable path includes a first line segment extending between at least two of the plurality of nodal sites and indicating a portion of the navigable path that has been reached by the medical instrument and a second line segment extending between at least two of the plurality of nodal sites and indicating a portion of the navigable path that has not been reached by the medical instrument, and wherein the first line segment is visually distinguishable from the second line segment”.
The examiner acknowledges that Periaswamy (US 2008/0298662 A1) does not cure the deficiencies of Kopel with respect to the limitation above.
Furthermore, during the examiner’s search, no prior art references were found to teach the above limitation both individually and in combination with Kopel.
Thus, claim 13 contains allowable subject matter and is therefore allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sartor et al. US 2018/0333095 A1 “Sartor” is pertinent to the applicant’s disclosure because it discloses “Turning now to FIG. 7, a flowchart illustrating an exemplary method 700 for performing lymph node surgical procedures and presenting lymph node information data 255 is shown, in accordance with the present disclosure. Method 700 details steps taken during removal of all or a portion of region of interest 209 and lymph nodes 205 and confirmation that accurate and correct lymph nodes 205 were removed. Method 700 begins at step 705 where a clinician selects a 3D model 215 including region of interest 209 or lymph node 205 for which a surgical procedure is to be performed. Next, at step 707, the selected 3D model is registered with the patient. Thereafter, at step 710, the clinician performs a laparoscopic procedure and moves surgical tool 32 and laparoscope 30 to region of interest 209 or lymph node 205, as further described in the detailed description of FIG. 1. As surgical tool 32 is moved to the physical location of lymph nodes 205 and/or region of interest 209, the location of EM sensor 94 of surgical tool 32 is tracked at step 715. Next, at step 720, using the physical location of laparoscope 30, laparoscopic view 310 changes. Location window 320 including images generated from 3D model 215 changes based on the physical location of EM sensor 94 of laparoscope 30 due to the registration between 3D model 215 and the patient and detection of EM sensor 94 in the EM field. Additionally, based on the location of EM sensor 94 of surgical tool 32 and or laparoscope camera 30, current and previous lymph node information data 255 of those lymph nodes 205 may be obtained. For example, where lymph nodes 205 have been previously biopsied, previous lymph node information data 255 may be obtained from computing device 80 and displayed” [0066].
Georgescu et al. US 2020/0193594 A1 “Georgescu” is pertinent to the applicant’s disclosure because it discloses “Systems and methods for identifying and assessing lymph nodes are provided. Medical image data (e.g., one or more computed tomography images) of a patient is received and anatomical landmarks in the medical image data are detected. Anatomical objects are segmented from the medical image data based on the one or more detected anatomical landmarks. Lymph nodes are identified in the medical image data based on the one or more detected anatomical landmarks and the one or more segmented anatomical objects. The identified lymph nodes may be assessed by segmenting the identified lymph nodes from the medical image data and quantifying the segmented lymph nodes. The identified lymph nodes and/or the assessment of the identified lymph nodes are output” [Abstract].
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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