DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/21/2026 has been entered.
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 05/21/2026. Claims 21-40 are pending. Claims 1-20 were previously cancelled. Claims 21 and 36 are amended. Claims 21-40 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/30/2024, 03/26/2025, 07/16/2025, 10/09/2025, and 11/17/2025, 04/15/2026 and 06/08/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks pages 5-9, filed 05/21/2026, with respect to the rejection of the claims under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive.
Regarding claim 21, the claim has been amended to recited “after receiving the user input and based on the user input, determining an uncertainty zone associated with the target”.
Applicant respectfully submits that the cited portions of Donhowe do not disclose at least the above-emphasized subject matter of amended claim 21. For example, the cited portions of Donhowe do not disclose "receiving a user input via the user input device associated with a target relative to the anatomical model" and "after receiving the user input and based on the user input, determining an uncertainty zone associated with the target" as recited by amended claim 21. (Emphasis added.)
Regarding "receiving a user input via the user input device associated with a target relative
to the anatomical model," the Office Action states:
In this case, this target structure is identified based on a user viewing the anatomical model (i.e. on display system 110) and selecting the target structure 302 (i.e. via the operator input system 106). Furthermore, the clinician selects a planned deployment location corresponding to the target structure. Therefore, the one or more processors perform the step of receiving a user input via the user input device associated with a target relative (i.e. target structure 302) to the anatomical model
(i.e. obtained in step 252 of FIG. 4). (Page 13) (emphasis added.)
In the Response to Arguments section, the Office Action further states:
The examiner respectfully asserts that the clinician selects a planned deployment location in order to carry out the interventional procedure on a target structure (See [0054]). In this case, the planned deployment location is within the target structure. Therefore, the one or more processors is configured to perform operations including: "receiving a user input via the user input device associated with a target relative to the anatomical model." (Page 7) (emphasis added.)
Regarding, "based on the user input, determining an uncertainty zone associated with the target," the Office Action states:
In this case, the probabilistic target region includes a collection or cloud of target points (i.e. target point cloud, see [0054], [0058]) which represent the uncertainties or error values associated with the location of the target structure. This probabilistic target region/target region 311 (i.e. target point cloud) is displayed around the theoretical location of the target (see [0061]) and its shape and size depends on the properties of the specific location in the anatomy of the target structure and takes into account areas to be avoided when conducting the interventional procedure. Therefore, the one or more processors perform the step of, based on the user input, determining an uncertainty zone (i.e. probabilistic target region/target point cloud/target region 311) associated with the target. (Page 14) (emphasis added.)
In the Response to Arguments section, the Office Action further states:
Furthermore, the examiner respectfully notes that the target region 311 (see FIG. 5, for example), represents an uncertainty zone because its size and shape: 1) dependent on the properties of the specific location in the anatomy of the target structure (i.e. corresponding to the planned deployment location); 2) take into account areas to be avoided when conducting an interventional procedure. Thus, the examiner respectfully asserts that Donhowe teaches that the one or more processors is configured to perform operations including "based on the user input, determining an uncertainty zone associated with the target." (Page 8) (emphasis added.).
The Office Action therefore appears to analogize: (1) the clinician's selection of a planned deployment location in Donhowe to "receiving a user input via the user input device associated with a target relative to the anatomical model" of claim 21, and (2) the target region 311 of Donhowe to the "uncertainty zone" of claim 21. Even assuming, without conceding, that the Office Action's statements and analogies are accurate, the cited portions of Donhowe do not disclose "after receiving the user input and based on the user input, determining an uncertainty zone associated with the target," as recited by amended claim 21. (Emphasis added.).
The examiner respectfully agrees that the Office Action analogizes: 1) the clinician's selection of a planned deployment location in Donhowe to "receiving a user input via the user input device associated with a target relative to the anatomical model" of claim 21, and (2) the target region 311 of Donhowe to the "uncertainty zone" of claim 21. Furthermore, the examiner acknowledges that Donhowe does not disclose "after receiving the user input and based on the user input, determining an uncertainty zone associated with the target," as recited by amended claim 21. (Emphasis added.).
Instead, the cited portions of Donhowe state (emphasis added):
At a process 256, a target structure is identified in the model frame of reference and is transformed to a location in the patient frame of reference. As shown in FIG. 5, a virtual image 300 from the model depicts a target structure 302, such as a tumor, and nearby anatomic passageways 304. The passageways include passageway walls 306 and carina 308. 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. (Para. [0056].)
Referring again to FIG. 4, a process 258 includes determining a target region which represents the location of the target structure 302 with respect to the instrument as a probabilistic collection or cloud of target points. The target region may be a three dimensional area in the patient reference frame. An image of the target region 311 is shown in FIG. 5. The target region 311 is comprised of a plurality of target points 312. The distribution of target points 312 and thus the three-dimensional shape of the target region may be based upon a variety of factors, as described above.... (Para. [0058].)
Referring again to FIG. 4, a process 262 includes identifying a planned catheter park location from which the interventional tool may be deployed. In one embodiment, a navigation planning module of the control system 112 identifies the planned deployment location as a location 314 along a wall of an anatomic passageway closest to or nearby to the target region or to specific target points within the target region(s). If more than one target region is identified, more than one deployment location may be determined. A different deployment location may also be identified for each target point. (Para. [0064].)
In use, a clinician or the control system may select a planned deployment location within an anatomical passageway for parking a distal end of the interventional instrument to conduct the interventional procedure on a target structure....Uncertainties or error values associated with the location of the target structure, with the registration of the patient model and the patient anatomy, and with the navigation of the interventional instrument impact the identification of a planned deployment location and the effectiveness of the procedure. As described below, the risk of missing the target structure due to navigational and target location uncertainty may be mitigated by representing the location of the target structure as a probabilistic target region including a collection or cloud of target points. The clinician or control system may select one or more deployment locations for parking the catheter within an anatomic passageway and then deploy the tool to engage multiple target points from the target region.... (Para. [0054].).
As noted above, Donhowe states: "[A] process 258 includes determining a target region which represents the location of the target structure 302 with respect to the instrument as a probabilistic collection or cloud of target points." (Para. [0058]) Donhowe then states: "a process 262 includes identifying a planned catheter park location from which the interventional tool may be deployed" (para. [0064]); and "[u]ncertainties or error values associated with the location of the target structure, with the registration of the patient model and the patient anatomy, and with the navigation of the interventional instrument impact the identification of a planned deployment location" (para. [0054]). Therefore, the cited portions of Donhowe do not disclose "after receiving the user input and based on the user input, determining an uncertainty zone associated with the target," as recited by amended claim 21. (Emphasis added.)
For at least these reasons, the cited portions of Donhowe do not disclose "receiving a user input via the user input device associated with a target relative to the anatomical model" and "after receiving the user input and based on the user input, determining an uncertainty zone associated with the target," as recited by amended claim 21. Accordingly, amended claim 21 is patentable over Donhowe.
Further, claims 22-27, 29-31, and 35, which depend from claim 21 and recite additional features, are patentable over Donhowe for at least the same reasons as those discussed above with respect to claim 21, and further in view of their own respective features.
The examiner respectfully agrees that Donhowe, particularly in the paragraphs cited above (i.e. [0058], [0064], and [0054]) does not disclose “after receiving the user input and based on the user input, determining an uncertainty zone associated with the target” as recited in amended claim 21.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Koudijs et al. US 2012/0120091 A1 “Koudijs” as discussed in the 35 U.S.C. 103 section below. Additionally, claims 22-27, 29-31 and 35, which depend from claim 21, are subject to the new ground(s) of rejection made in view of Koudijs as stated in the 35 U.S.C. 103 section below.
Independent Claim 36
Amended independent claim 36 recites features similar to those recited in amended independent claim 21. Therefore, the Applicant argues that claim 36 is patentable over Donhowe for at least the same reasons as those discussed above with respect to claim 21, and further in view of its own respective features.
Further, claims 37-40, which depend from claim 36 and recite additional features, are patentable over Donhowe for at least the same reasons as those discussed above with respect to claim 36, and further in view of their own respective features.
The examiner respectfully notes that this claim recites similar features to that of amended claim 21, therefore, this claim is subject to the reasoning provided therein. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Koudijs et al. US 2012/0120091 A1 “Koudijs” as discussed in the 35 U.S.C. 103 section below.
Applicant’s arguments, see Remarks pages 9-10, filed 05/21/2026, with respect to the rejection of claims 28, and 32-34 under 35 U.S.C. 103 have been fully considered and are not persuasive with respect to claim 28, but are persuasive with respect to claims 32-34.
Compliance with § 103 - Donhowe and Koudijs
Dependent claim 28 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Donhowe in view of U.S. Pat. App. Pub. No. 2012/0120091 to Koudijs et al. ("Koudijs"). Applicant respectfully submits that Koudijs fails to remedy the deficiencies of Donhowe with respect to independent claim 21. Accordingly, Applicant respectfully requests that the rejection of claim 28 be withdrawn and that claim 28 be allowed.
The examiner respectfully asserts that Donhowe teaches the limitations of claim 21 for the reasons stated above. Furthermore, the examiner respectfully maintains that Koudijs teaches “after receiving the user input and based on the user input, determining an uncertainty zone associated with the target” as recited claim 21 (i.e. as stated in the 35 U.S.C 103 section below) and features of claim 28 not taught by Donhowe.
Therefore, the examiner respectfully maintains the rejection of claim 28 for the reasons stated in the 35 U.S.C. 103 section below.
Compliance with § 103 - Donhowe and Kesten
Dependent claim 32 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Donhowe in view of U.S. Pat. App. Pub. No. 2016/0008083 to Kesten et al. ("Kesten"). Applicant respectfully submits that Kesten fails to remedy the deficiencies of Donhowe with respect to independent claim 21. Accordingly, Applicant respectfully requests that the rejection of claim 32 be withdrawn and that claim 32 be allowed.
The examiner respectfully asserts that Donhowe teaches the limitations of claim 21 for the reasons stated above. Furthermore, the examiner respectfully maintains that Kesten teaches the features of claim 32 not taught by Donhowe. In spite of this, the examiner respectfully notes that this claim is subject to the new ground(s) of rejection made in view of Koudijs et al. US 2012/0120091 A1 “Koudijs” as stated in the 35 U.S.C. 103 section below.
Compliance with § 103 - Donhowe and Bharadwaj
Dependent claims 33 and 34 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Donhowe in view of U.S. Pat. App. Pub. No. 2016/0038248 to Bharadwaj et al. ("Bharadwaj"). Applicant respectfully submits that Bharadwaj fails to remedy the deficiencies of Donhowe with respect to independent claim 21. Accordingly, Applicant respectfully requests that the rejection of claims 33 and 34 be withdrawn and that claims 33 and 34 be allowed.
The examiner respectfully asserts that Donhowe teaches the limitations of claim 21 for the reasons stated above. In spite of this, the examiner respectfully notes that this claim is subject to the new ground(s) of rejection made in view of Koudijs et al. US 2012/0120091 A1 “Koudijs” as stated in the 35 U.S.C. 103 section below.
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) 21-31, and 33-40 is/are rejected under 35 U.S.C. 103 as being unpatentable by Donhowe et al. WO 2016/018648 A1 “Donhowe” and further in view of Koudijs et al. US 2012/0120091 A1 “Koudijs”.
Regarding claims 21 and 36, Donhowe teaches “A system comprising: a display system; a user input device; and one or more processors configured to perform operations including:” (Claim 21) (“As shown in FIG. 1, the teleoperated system 100 generally includes an interventional manipulator assembly 102 for operating an interventional instrument 104 in performing various procedures on the patient P” [0023]; “The teleoperational medical system 100 also includes a display system 110 for displaying an image or representation of the surgical site and medical instrument system(s) 104 generated by sub-systems of the sensor system 108. The display 110 and the operator input system 106 may be oriented so the operator can control the medical instrument system 104 and the operator input system 106 with the perception of telepresence” [0028]; “The teleoperational medical system 100 also includes a control system 112. The control system 112 includes at least one memory and at least one processor (not shown), and typically a plurality of processors, for effecting control between the medical instrument system 104, the operator input system 106, the sensor system 108, and the display system 110” [0033]. Therefore, Donhowe discloses a system (i.e. teleoperated system 100) comprising a display system (i.e. display system 110), a user input device (i.e. operator input system 106) and one or more processors (i.e. within control system 112) configured to perform operations.);
“A non-transitory machine-readable media storing instructions that, when run by one or more processors, cause the one or more processors to:” (Claim 36) (“The control system 112 also includes programmed instructions (e.g., a computer-readable medium storing the instructions) to implement some or all of the methods described in accordance with aspects disclosed herein” [0033]; “Processor readable storage device examples include an electronic circuit; a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device” [0079]. Therefore, the processor readable storage device/computer-readable medium represents a non-transitory machine-readable media storing instructions that when run by one or more processors, cause the one or more processors to perform specific functions.); and
“receiving an anatomical model” (Claims 21 and 36) (“FIG. 4 illustrates a method 250 for identifying a procedure deployment location and navigating an interventional instrument to the deployment location. A process 252 includes obtaining an anatomical model of a patient anatomy. The anatomical model may be developed from an acquired dataset associated with the three dimensional structure of the anatomical passageways. More specifically, the model may be obtained by processing images of the interventional site recorded using imaging technology such as CT, MRI, fluoroscopy, thermography, ultrasound, OCT, DOT, thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, or the like” [0055]. Therefore, the one or more processors receive an anatomical model.);
“receiving a user input via the user input device associated with a target relative to the anatomical model” (Claim 21); “receive a user input via a user input device associated with a target relative to the anatomical model” (Claim 36) (“In use, a clinician or the control system may select a planned deployment location within an anatomical passageway for parking a distal end of the interventional instrument to conduct the interventional procedure on a target structure. […] Uncertainties or error values associated with the location of the target structure, with the registration of the patient model and the patient anatomy, and with the navigation of the interventional instrument impact the identification of a planned deployment location and the effectiveness of the procedure. As described below, the risk of missing the target structure due to navigational and target location uncertainty may be mitigated by representing the location of the target structure as a probabilistic target region including a collection or cloud of target points. The clinician or control system may select one or more deployment locations for paring the catheter within an anatomic passageway and then deploy the tool to engage multiple target point from the target region” [0054]; “At a process 256, a target structure is identified in the model frame of reference and is transformed to a location in the patient frame of reference. As shown in FIG. 5, a virtual image 300 from the model depicts a target structure 302, such as a tumor, and nearby anatomic passageways 304” [0056]. In this case, this target structure is identified based on a user viewing the anatomical model (i.e. on display system 110) and selecting the target structure 302 (i.e. via the operator input system 106). Furthermore, the clinician selects a planned deployment location corresponding to the target structure. Therefore, the one or more processors perform the step of receiving a user input via the user input device associated with a target relative (i.e. target structure 302) to the anatomical model (i.e. obtained in step 252 of FIG. 4); […] and […]
“an uncertainty zone […] display(ing) the target relative to the anatomical model via the display system, wherein the uncertainty zone is displayed as at least partially surrounding the target” (Claims 21 and 36) (“As shown in FIG. 5, a virtual image 300 from the model depicts a target structure 302, such as a tumor, and nearby anatomic passageways 304” [0056]; “The target region may be a three dimensional area in the patient reference frame. An image of the target region 311 is shown in FIG. 5. The target region 311 is comprised of a plurality of target points 312. The distribution of target points 312 and thus the three-dimensional shape of the target region may be based upon a variety of factors, as described above. For example, the probabilistic distribution of the location of the target structure in the patient frame of reference may contribute to the point distribution” [0058]. As shown in FIG. 5, the target region 311 includes a plurality of target points 312 which represent the probabilistic distribution (i.e. probabilistic target region/target point cloud, see [0054], [0058]). Furthermore, this target region 311 partially surrounds the target structure 302 (i.e. the target). Therefore, the one or more processors perform the step of displaying the target (i.e. 302) relative to the anatomical model via the display system (i.e. 110), wherein the uncertainty zone (i.e. 312 representing the probabilistic target region/target point cloud) is displayed as at least partially surrounding the target (i.e. 302)).
However, Donhowe does not teach “after receiving the user input and based on the user input, determining an uncertainty zone associated with the target” (Claim 21); “after receiving the user input and based on the user input, determine an uncertainty zone associated with the target” (Claim 36).
Koudijs is within the same field of endeavor as the claimed invention because it involves a method and system for visualizing a surgical path for a surgical tool (see [Abstract]).
Koudijs teaches “after receiving the user input and based on the user input, determining an uncertainty zone associated with the target” (Claim 21); “after receiving the user input and based on the user input, determine an uncertainty zone associated with the target” (Claim 36) (“The method to be performed by the processor 11 is schematically represented by the flow diagram of FIG. 2. In a data receiving step 21, the processor 11 receives all input data 20 that is used for visualizing a surgical path using the method of the invention. The input data 20 comprises geometric information describing the surgical path. […] The input data 20 further comprises at least one safety margin. Safety margins may, e.g., be provided together with the anatomical information or set by a user via the user interface 16” [0031]; “In an alternative embodiment, the safety margin may be drawn around the anatomical structure and violation indicators may point towards the anatomical structures coming too close to the surgical tool” [0049]. In this case, the safety margin represents the area in which the target is located an constitutes an uncertainty zone. Thus, since the safety margin is set by a user via the user interface, the processor 11 is configured to, after receiving the user input and based on the user input, determine an uncertainty zone (i.e. safety zone) associated with the target (i.e. anatomical structure).).
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 and non-transitory machine-readable media of Donhowe such that the one or more processors are configured to perform operations including: after receiving the user input and based on the user input, determining an uncertainty zone associated with the target as disclosed in Koudijs in order to effectively establish an area in which a procedure should be performed with respect to an anatomical target. Obtaining a user input to determine an uncertainty zone associated with the target is one of a finite number of techniques which can be used to establish an area where a procedure should be performed with a reasonable expectation of success. Thus, modifying the system and non-transitory machine-readable media of Donhowe such that the one or more processors are configured to perform operations including: after receiving the user input and based on the user input, determining an uncertainty zone associated with the target as disclosed in Koudijs would yield the predictable result of effectively establishing an area in which a procedure should be performed with respect to an anatomical target.
Regarding claims 22 and 37, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claims 21 and 36 above, and Donhowe further teaches “wherein the anatomical model is registered to an anatomy, and wherein the uncertainty zone is determined based on a registration uncertainty” (Claims 22 and 37) (See [0054] as discussed with respect to claims 21 and 36 above; “At a process 254, the model frame of reference is registered to a patient frame of reference so that the locations of anatomic structures identified in the model can be transformed to the patient frame of reference in which the actual patient and interventional instrument exist” [0056]; “A variety of error factors contribute to uncertainty about the true location of the target structure 302 relative to the instrument 307. For example, an error factor may be associated with movement of the patient after the model and patient frames of reference have been registered” [0057]. Therefore, the anatomical model (i.e. model frame of an anatomic structure) is registered to an anatomy (i.e. within the patient frame of reference). Furthermore, since a probabilistic target region including a collection or cloud of target points is generated to mitigate uncertainties or error values associated with the location of the target structure with the registration of the patient model and the patient anatomy (See [0054]), the uncertainty zone is determined based on a registration uncertainty. Thus, the anatomical model (i.e. model 300, for example) is registered to an anatomy (i.e. in the patient frame) and the uncertainty zone (i.e. probabilistic target region/target point cloud, see [0054], 311 in FIG. 5) is determined based on a registration uncertainty.).
Regarding claims 23 and 38, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claims 21 and 36 above, and Koudijs further teaches “wherein the uncertainty zone is determined based on a size of the target” (See [0031] and [0049] as discussed with respect to claims 21 and 36. In order for the user to set the safety margin (i.e. uncertainty zone) such that it surrounds the anatomical structure (See [0049]), the uncertainty zone is determined based on a size of the target.).
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 and non-transitory machine-readable media of Donhowe such that the one or more processors are configured to perform operations including: after receiving the user input and based on the user input, determining an uncertainty zone associated with the target, the uncertainty zone being determined based on a size of the target as disclosed in Koudijs in order to effectively establish an area in which a procedure should be performed with respect to an anatomical target. Obtaining a user input to determine an uncertainty zone associated with the size of a target is one of a finite number of techniques which can be used to establish an area where a procedure should be performed with a reasonable expectation of success. Thus, modifying the system and non-transitory machine-readable media of Donhowe such that the one or more processors are configured to perform operations including: after receiving the user input and based on the user input, determining an uncertainty zone associated with the target, the uncertainty zone being determined based on a size of the target as disclosed in Koudijs would yield the predictable result of effectively establishing an area in which a procedure should be performed with respect to an anatomical target.
Regarding claims 24 and 39, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claims 21 and 36 above, and Donhowe further teaches “wherein the anatomical model includes a model of a patient anatomy, and wherein the uncertainty zone is determined based on a position of the target relative to the patient anatomy” (See [0054] and [0061] as discussed with respect to claims 21 and 36 above. Therefore, the anatomical model (i.e. 300) includes a model of patient anatomy (i.e. anatomic passageways 304), wherein the uncertainty zone (i.e. 311) is determined based on a position of the target (i.e. 302) relative to the patient anatomy (i.e. main bronchi or anatomic passageways 304).).
Regarding claims 25 and 40, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claims 21 and 36 above, and Donhowe further teaches “wherein the uncertainty zone is determined based on an expected difficulty to access the target” (“The size and shape of the target region may also be influenced by the chance of a successful procedure. For example, a successful biopsy may be dependent upon avoiding target points with a trajectory nearly parallel to the approaching airway since such an approach would increase the risk of the interventional tool deflecting into an airway instead of puncturing the wall to obtain a biopsy” [0061]. Therefore, since the size and shape of the target region (i.e. 311) is influenced by the chance of a successful procedure (i.e. associated with the difficulty of said procedure), the uncertainty zone is determined based on an expected difficulty to access the target (i.e. 302).).
Regarding claim 26, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 21 above, and Donhowe further teaches “wherein the operations further include: determining a location of a potential hazard” (“The size and shape of the target region may also take into account areas to be avoided when conducting the interventional procedure. Areas to be avoided may include areas in which conducting an interventional procedure may be dangerous to the patient or areas that may be inaccessible. Areas to avoid may include blood vessels, bone, boundaries of the lung (e.g., near the pleura or diaphragm) or sensitive organs and therefore, the presence of these anatomical features may influence the size and shape of the target region” [0061]. Therefore, in order for the size and shape of the target region (i.e. 311) to take into account areas to be avoided (i.e. blood vessels, bone, boundaries of the lung, and/or sensitive organs), the operations performed by the one or more processors must further include determining a location of a potential hazard (i.e. areas to be avoided such as blood vessels, bone, boundaries of the lung, and/or sensitive organs).).
Regarding claim 27, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 26 above, and Donhowe further teaches “wherein the operations further include: displaying the potential hazard relative to the anatomical model via the display system” (See [0061] as discussed with respect to claim 26 above, and [0056] as discussed with respect to claims 21 and 36 above. Additionally, FIG. 5 shows boundaries of anatomic passageways 304, specifically passageway walls 306 and carina 308, these anatomic passageways representing bronchial passageways of the lung. Therefore, the one or more processors are further configured to display the potential hazard (i.e. boundaries of the lung, 306/308) relative to the anatomical model (i.e. 300) via the display system (i.e. 110 in FIG. 1).).
Regarding claim 28, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 27 above, and Koudijs further teaches “wherein the potential hazard is displayed with a different appearance than the anatomical model” (“With the method according to the invention, the path's critical information is provided in an easily interpretable and easily accessible way. Where the path tends to come to close to an important anatomical structure, it is highlighted. A user can easily see whether a path comprises critical segments. Especially in cases with complicated 3D anatomical geometry this allows a user to very quickly assess which part of a selected or proposed trajectory bears a risk related to a specific structure. […] Highlighting critical segments may, e.g., be done using color coding or different shades or by drawing circles or other shapes around the critical segments” [0007]; “Highlighting critical and/or restricted segments may be done in a lot of different ways. For examples, the highlighted segments may have a different color or shading than other parts of the surgical path. […] Different segments may be highlighted differently. E.g. a color coding may be used for showing what kind of structure (e.g., blood vessel, nerve) is threatened or what kind of restriction is violated” [0036].
Therefore, since critical structures (i.e. blood vessels, nerve) are highlighted using color coding or different shades to allow a user to easily interpret the location of these structures. Therefore, the potential hazard (i.e. critical structures such as blood vessels or nerves) is displayed with a different appearance (i.e. color or shade) than the anatomical model (i.e. 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 Donhowe such that the potential hazard (i.e. blood vessels, bone, boundaries of lung, or sensitive organs, see Donhowe: [0061]) is displayed with a different appearance than the anatomical model as disclosed in Koudijs in order to allow a user to easily interpret the location of the potential hazard when planning a surgical procedure. Highlighting critical structures (i.e. potential hazards) within an image is one of a finite number of techniques which can be used to allow a user to prepare a surgical procedure/path which avoids those critical structures with a reasonable expectation of success. Thus, modifying the system of Donhowe such that the display shows the potential hazard (i.e. blood vessels, bone, boundaries of lung, or sensitive organs, see Donhowe: [0061]) with a different appearance than the anatomical model as disclosed in Koudijs in order to allow a user to easily interpret the location of potential hazards when planning a surgical procedure.
Regarding claim 29, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 26 above, and Donhowe further teaches “wherein the anatomical model is enclosed by a boundary, and wherein the potential hazard corresponds to at least a portion of the boundary near the target” (See [0061] as discussed with respect to claim 26 above. As shown in FIG. 5, the anatomical model 300 includes the target region 311 which encloses at least part of the target region 302 and a portion passageway wall 306 (i.e. potential hazard corresponding to the boundary of the lung (e.g., near the pleura or diaphragm), see [0061]). Therefore, the anatomical model is enclosed by a boundary (i.e. 311), and wherein the potential hazard (i.e. boundary of the lung 306) corresponds to at least a portion of the boundary (i.e. 311) near the target (i.e. 302).).
Regarding claim 30, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 21 above, and Donhowe further teaches “wherein the anatomical model includes anatomical passageways” (“As shown in FIG. 5, a virtual image 300 from the model depicts a target structure 302, such as a tumor, and nearby anatomic passageways 304. The passageways include passageway walls 306 and carina 308. 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. The virtual image 300 further depicts an image of an interventional instrument 307 registered with the image of the anatomy” [0056]. Therefore, the anatomical model (i.e. 300) includes anatomical passageways (i.e. anatomic passageways 304).).
Regarding claim 31, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 30 above, and Donhowe further teaches “wherein the target is displayed outside of the anatomical passageways of the anatomical model” (See [0056] as discussed with respect to claim 30 above. As shown in FIG. 5, the target structure 302 (i.e. the target) is located outside of the anatomical passageways (i.e. 304) of the anatomical model (i.e. 300). Therefore, the target is displayed outside of the anatomical passageways of the anatomical model.).
Regarding claims 33 and 34, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 21 above, and Koudijs “wherein the display system includes a touchscreen” (Claim 33) and “wherein receiving the user input via the user input device includes receiving the user input via the touchscreen” (Claim 34) (“The user interface 16 may comprise all kinds of known user interface elements, such as a keyboard, pointing device, touch pad, touch screen or speech recognition system” [0028]. Therefore, the display system includes a touch screen and the step of receiving the user input via the user input device includes receiving the user input via the touchscreen.
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 Donhowe such that the display system includes a touchscreen and the step of receiving the user input via the user input device includes receiving the user input via the touchscreen as disclosed in Koudijs in order to simplify the process of selecting a target within the anatomical model. A touchscreen is one of a finite number of devices which can be used to provide an input to select a target structure with a reasonable expectation of success. Modifying the display system (i.e. 110) of Donhowe such that it includes a touchscreen, wherein the step of receiving the user input involves receiving the user input via the touchscreen as disclosed in Koudijs would yield the predictable result of allowing a user to easily provide an input to select a target within the anatomical model.
Regarding claim 35, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 21 above, and Donhowe further teaches “wherein receiving the user input via the user input device includes receiving the user input to identify a location of the target relative to the anatomical model” (See [0056] as discussed with respect to claim 21 above. In this case, this target structure (i.e. 302) is identified based on a user viewing the anatomical model (i.e. on display system 110) and selecting the target structure 302 with the operator input system 106). Therefore, the step of receiving the user input via the user input device includes receiving the user input (i.e. via the operator input system 106) to identify a location of the target (i.e. 302) relative to the anatomical model (i.e. 300).).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donhowe et al. WO 2016/018648 A1 “Donhowe” and Koudijs et al. US 2012/0120091 A1 “Koudijs” as applied to claim 21 above, and further in view of Kesten et al. US 2016/0008083 A1 “Kesten”.
Regarding claim 32, Donhowe in view of Koudijs discloses all features of the claimed invention as discussed with respect to claim 31 above, however the combination does not teach “wherein the anatomical passageways of the anatomical model are displayed in a translucent manner”.
Kesten is within the same field of endeavor as the claimed invention because it involves a graphical user interface which allows a user to define transparency and/or color for each anatomical structure (See [0085]).
Kesten teaches “wherein the anatomical passageways of the anatomical model are displayed in a translucent manner” (“By way of example only, this GUI may enable the physician (54) to define a transparency and/or color for each anatomical structure as desired (step (510)). As one merely illustrative example, where the three-dimensional image is being prepared to provide an operation plan to dilate a maxillary sinus ostium, the physician may set a graphical representation of the uncinate process as being approximately 50% transparent; and color the maxillary sinus ostium red” [0085]. An anatomical structure which is approximately 50% transparent is a translucent anatomical structure. Thus, since the GUI enables the physician to define a transparency for each anatomical structure in the three-dimensional image as desired (i.e. 50% transparent, for example), the anatomical passageways of the anatomical model (i.e. anatomical structures) are configured to be displayed in a translucent manner.).
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 Donhowe in view of Koudijs such that the user interface enables a physician to define a transparency for each anatomical structure as disclosed in Kesten such that anatomical passageways (i.e. 306) of the anatomical model (i.e. 300) are displayed in a translucent manner (i.e. 50% transparent, for example) in order to allow a user to more easily view features within an image. Displaying an anatomical structure (i.e. passageway) with a translucent manner is one of a finite number of techniques which can be used to suppress certain features within an image and therefore allow a user to more easily view features of interest. Therefore, modifying the system of Donhowe in view of Koudijs such that the anatomical passageways of the anatomical model are displayed in a translucent manner (i.e. 50% transparent, for example) as disclosed in Kesten would yield the predictable result of allowing a user to more easily view anatomical features of interest.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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