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 .
Response to Amendment
Claims 22-41 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 05/15/2026.
Response to Arguments
Applicant’s arguments, see pg. 11-12, filed 08/13/2026, with respect to the rejection(s) of claim(s) 22 under 35 U.S.C. 103 (Krimsky in view of Kim), 35 U.S.C. 101, and 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Krimsky in view of Kim and Hillis, as shown below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 22-28, 30-36, and 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Krimsky (US 20210153955 A1, published May 27, 2021 with a priority date of September 1, 2016) in view of Kim et al. (US 20170000567A1, published January 5, 2017) and Hillis et al. (US 20090222059 A1, published September 3, 2009), hereinafter referred to as Krimsky, Kim, and Hillis, respectively.
Regarding claim 22, Krimsky teaches a method (Fig. 3A-3C) comprising:
displaying image data of an anatomical region via a display system (Fig. 4, 3D model 408 (from image data) of lung (anatomical region); see para. 0050 "The planning phase of method 300 may begin at step S302, where computing device 80 receives image data of the patient's chest, including the patient's lungs."; see para. 0051 "At step S304, a 3D model of the patient's chest is generated. The 3D model may be based on the image data received during stepS302...");
determining a target location in the anatomical region (Fig. 4, target 415 as target region in anatomical region (lung); see para. 0053 "At step S308, a target location is identified in the 3D model of the patient's airways.");
determining an anatomical boundary, the anatomical boundary indicating a surface of an anatomical structure in the anatomical region, the anatomical structure to be avoided by a tool extendable from a medical instrument (see para. 0052 "Thereafter, at step S306, a location of anatomical features [anatomical boundary], such as the pleura of the patient's lungs as well as vascular structures and/or other physiological elements is determined...");
determining a path between a distal end of the medical instrument and the target location (Fig. 4; see para. 0070 "At trajectory 404 may show the trajectory of EM sensor 94." trajectory 404 is between digital marker 406 representing EM sensor 94 of catheter 100 (medical instrument) of Fig. 1 and target location 415),
wherein the target location is between the distal end of the medical instrument and the anatomical boundary (Fig. 4, target location (target 415) is between instrument (digital marker 406 representing EM sensor 94 of catheter 100 (medical instrument) of Fig. 1) and boundary (pleural surface 402)); and
determining a zone boundary based on an intersection of the trajectory zone with the anatomical boundary (Fig. 4, zone boundary as area between the trajectory zone (trajectory 404) and the anatomical boundary (pleural surface 402), such as area of proximity indicator 410).
Krimsky teaches determining a path between a distal end of the medical instrument and the target location, but does not explicitly teach a trajectory zone around the path.
Whereas, Kim, in an analogous field of endeavor, teaches a trajectory zone around a path (Fig. 22b, safe entry region 280 (trajectory zone) around central line 250 (path); see para. 0120 "The safe entry region 280 thus generated represents the range of an insertion trajectory that is applicable to an actual surgical operation.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a path between a distal end of the medical instrument and the target location, as disclosed in Krimsky, by having a trajectory zone around the path, as disclosed in Kim. One of ordinary skill in the art would have been motivated to make this modification in order to provide a safe range of an insertion trajectory that is applicable to an actual surgical operation without invading prohibited regions, as taught in Kim (see para. 0120).
Krimsky in view of Kim teaches determining an anatomical boundary, but does not explicitly teach determining an anatomical boundary based on the target location.
Whereas, Hillis, in an analogous field of endeavor, teaches determining an anatomical boundary based on the target location (see para. 0048 – “For example, a practitioner may identify a target area to reach with the shaped surgical tool 402 and may, based on general anatomical knowledge, wish to avoid a region proximate to the target area…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determining an anatomical boundary, as disclosed in Krimsky, by also determining the anatomical boundary based on the target location, as disclosed in Hillis. One of ordinary skill in the art would have been motivated to make this modification in order to decide on and obtain a user-specific shaped surgical tool of a specific shape, as taught in Hillis (see para. 0048).
Furthermore, regarding claim 23, Krimsky further teaches displaying the zone boundary with the image data via the display system (Fig. 4, zone boundary as area between the trajectory zone (trajectory 404) and the anatomical boundary (pleural surface 402), such as area of proximity indicator 410).
Furthermore, regarding claim 24, Krimsky further teaches wherein displaying the zone boundary comprises overlaying the zone boundary on the image data via the display system (Fig. 4, zone boundary as area between the trajectory zone (trajectory 404) and the anatomical boundary (pleural surface402), such as area of proximity indicator410).
Furthermore, regarding claim 25, Krimsky further teaches wherein determining the anatomical boundary further comprises determining at least one intersection of a target border region with the anatomical structure (Fig. 5, target 615 of lungs 625 (anatomical structure)).
Furthermore, regarding claim 26, Krimsky further teaches wherein determining the trajectory zone comprises determining a distance between the distal end of the medical instrument and a distal end of the tool extendable from the medical instrument (Fig. 1; see para. 0038 "Catheter guide assemblies 90, 100 including LG 92 and EWC [extended working channel] 96 are configured for insertion through a working channel of bronchoscope 50 into the patient's airways...In the operation of each assembly 90, 100, a locatable guide (LG) 92, including an EM sensor 94, is inserted into EWC 96 and locked into position such that EM sensor 94 extends a desired distance beyond the distal tip 93 of EWC 96.").
Furthermore, regarding claim 27, Krimsky further teaches displaying an intersection point between the zone boundary and a tool trajectory of the tool (Fig. 4, any point along proximity indicator 410 (intersection point) between zone boundary (pleural surface 402) and tool trajectory 404).
Furthermore, regarding claim 28, Kim further teaches receiving, via a user input device, a user input adjusting an angle of the trajectory zone, wherein the trajectory zone is cone-shaped (Fig. 9; see para. 0096 "Besides this insertion trajectory 251, another insertion trajectory can be selected [user input] within the range of the narrowed entry region 235 [cone-shaped trajectory zone].").
Furthermore, regarding claim 30, Krimsky further teaches displaying guidance information via the display system during the determination of the zone boundary (see para. 0071 "While the above provided embodiments are directed to providing proximity awareness to pleural surfaces and/or vascular structures, it is envisioned that the above-described system may be used to provide guidance while navigating to a pleural surface or vascular structure, for example, to inject a dye or place a marker subpleurally or proximate the pleural surface or vascular structure.").
Furthermore, regarding claim 31, Krimsky further teaches deforming the zone boundary to conform with deformations of an anatomic model derived from the image data based on movement of a patient anatomy; and displaying the deformed zone boundary (see para. 0052 "In addition, data regarding the movement of the patient's airways during the patient's respiratory cycle may be used to compensate for differences in the detected locations of the pleural surfaces and vascular structures.'").
Furthermore, regarding claim 32, Krimsky further teaches displaying the anatomical boundary overlaid on fluoroscopic image data obtained during a patient procedure (Fig. 4; see para. 0060 "For example, after EM sensor 94 is navigated to the target location, placement of EM sensor 94 at the target location may be confirmed using one or more imaging modalities, including a CT scan, a CBCT scan, an ultrasound scan, and/or fluoroscopy.").
Furthermore, regarding claim 33, Krimsky further teaches displaying the zone boundary overlaid on an anatomic model derived from the image data (Fig. 4, zone boundary as area between the trajectory zone (trajectory 404) and the anatomical boundary (pleural surface 402), such as area of proximity indicator 410).
Furthermore, regarding claim 34, Krimsky further teaches receiving a user input via a user input device while the medical instrument is located within the anatomical region; and responsive to the user input, directing an orientation of the distal end of the medical instrument away from the zone boundary (see para. 0062 "In another embodiment where EM sensor94 [of medical instrument] is being navigated away from the anatomical feature, such as the pleura, [zone boundary] the distance and direction from the pleura may be determined.").
Furthermore, regarding claim 35, Krimsky further teaches determining a distance between a distal end of the tool and the zone boundary (Fig. 4, measure 412(distance) between digital marker406 of tool and zone boundary (pleural surface 402)).
Furthermore, regarding claim 36, Krimsky further teaches providing a visual, audible, or haptic indicator when the distance between the distal end of the tool and the zone boundary is less than a predetermined threshold distance (see para. 0065 "If it is determined that EM sensor 94 [distal end of tool] is in close proximity to a pleural surface and/or vascular structure [less than predetermined threshold distance], a proximity alert is provided at step S332, whereafter processing returns to step S318. The proximity alert may be a visual alert displayed by application 81 and/or an audible or sensory alert provided by application 81.").
Furthermore, regarding claim 38, Kim further teaches providing one or more suggested deployment locations for the medical instrument, wherein the one or more suggested deployment locations are located at least a threshold distance from the zone boundary (Fig. 22, suggested deployment locations as entry points of safe entry region 280; see para. 0120 "Whether or not the initial entry region 240 intersects with the invasion prohibited regions 120, 140, the initial entry region 240 is diminished anyway such that it is spaced a marginal distance away [threshold distance] from the boundary of the invasion prohibited regions 120, 140 [zone boundary] to ensure the safety involved.").
Furthermore, regarding claim 39, Krimsky further teaches determining a viability of the path by at least determining whether the tool extendable from the medical instrument will puncture a portion of interest of a patient anatomy along the path (Fig. 4, viability of path as distance between tool 406 and pleural surface 402 (portion of interest)).
Furthermore, regarding claim 40, Krimsky further teaches wherein the portion of interest includes at least one of a pleura of the patient anatomy, a fissure of the patient anatomy, or blood vessels in the patient anatomy (Fig. 4; see para. 0046 "The 3D model may include, among other things, a model airway tree corresponding to the actual airways of the patient's lungs, and showing the various passages, branches, and bifurcations of the patient's actual airway tree. Additionally, the 3D model may include lesions, markers, blood vessels and vascular structures, lymphatic vessels and structures, organs, other physiological structures, and/or a 3D rendering of the pleura.").
Furthermore, regarding claim 41, Krimsky further teaches displaying the target location with the image data via the display system (Fig. 4, displaying target 415 in GUI 400 of display).
The motivation for claims 28 and 38 was shown previously in claim 22.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Krimsky in view of Kim and Hillis, as applied to claim 22 above, and in further view of Khadem et al. (US 20090259230 A1, published October 15, 2009), hereinafter referred to as Khadem.
Regarding claim 29, Krimsky in view of Kim and Hillis teaches all of the elements disclosed in claim 22 above.
Krimsky in view of Kim and Hillis teaches determining trajectory zones, but does not explicitly teach determining additional trajectory zones.
Whereas, Khadem, in an analogous field of endeavor, teaches wherein determining the zone boundary comprises determining additional trajectory zones and determining the zone boundary based on an intersection of each trajectory zone with the anatomical boundary (Fig. 3-4; see para. 0071-0072 "The processor, either alone or in combination with the user 22, can also identify a plurality of trajectories from each of the entry points 166 a-166 C to the target 164. The plurality of trajectories can be identified as various regions of trajectories 170 a-170 c.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determining trajectory zones, as disclosed in Krimsky in view of Kim and Hillis, by determining additional trajectory zones, as disclosed in Khadem. One of ordinary skill in the art would have been motivated to make this modification in order to allow for greater variability of specific surgical occurrences, such as placement of an instrument guide, movement of the instrument, brain or anatomical shift, and other various factors, as taught in Khadem (see para. 0058).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Krimsky in view of Kim and Hillis, as applied to claim 35 above, and in further view of Zhang et al. (CN 109875659 A, published June 14, 2019), hereinafter referred to as Zhang.
Regarding claim37, Krimsky in view of Kim and Hillis teaches all of the elements disclosed in claim 35 above.
Krimsky in view of Kim and Hillis teaches moving a tool, but does not explicitly teach altering the advancement speed of the tool.
Whereas, Zhang, in an analogous field of endeavor, teaches altering an advancement speed of the tool based on the determined distance (see pg. 4, para. 4 "two direct current motors, one is used for controlling the feeding motor of the flexible needle feeding speed...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified moving a tool, as disclosed in Krimsky in view of Kim and Hillis, by also altering the advancement speed of the tool, as disclosed in Zhang. One of ordinary skill in the art would have been motivated to make this modification in order to obtain needle movement control, as taught in Zhang (see Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Abovitz et al. (US 20040034302 A1, published February 19, 2004) discloses defining the target region on the display device, then defining the anatomical obstacles to be avoided during surgery on the display device (Fig. 3C).
Mukumoto et al. (US 20140072099 A1, published March 13, 2014) discloses a X-ray CT apparatus, where a configuration by which a puncture needle insertion route and new insertion route are set while avoiding blood vessels.
Vancamberg et al. (US 20110270270 A1, published November 3, 2011) discloses allowing the tool to avoid obstacles contained within the tissular matrix, and the tool passes at a certain distance from the obstacles. Taking into account the obstacles during determination of the insertion trajectory improves the comfort of the patient, for example by decreasing pain, and also improves the safety of the procedure.
Miyamoto (US 20150272692 A1, published October 1, 2015) discloses storing obstacle regions which are set in advance as regions that will become obstacles in ranges of view within the three dimensional region, judging whether each of the plurality of line of sight vectors pass through the obstacle regions or pass through the vicinities of the obstacle regions, and displaying projected images generated for line of sight vectors which have been judged to pass through the obstacle regions or the vicinities thereof and projected images generated for line of sight vectors which has been judged to not pass through the obstacle regions or the vicinities thereof in a visually distinguishable manner.
Glozman et al. (US 20090149867 A1, published June 11, 2009) discloses calculates a needle tip trajectory that hits the desired target while avoiding potentially dangerous obstacles en route by a predetermined distance.
Jenkins et al. (US 20100312095 A1, published December 9, 2010) discloses generating proximity alerts for an MRI-guided procedure associated with at least one target site and/or at least one avoid zone.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
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