The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 15, 2026 has been entered.
Response to Arguments
The previous rejections of claims 22, 35 and 38 under 35 USC 112(a) are withdrawn in view of the amendments to claims 22 and 35 and the cancellation of claim 38.
The previous rejections of claims 24, 27 and 35-37 under 35 USC 112(b) are withdrawn in view of the amendments to claim 35 and the cancellation of claims 24, 27 and 36-37.
The respect to the prior art rejections utilizing Simon in view of Karmarkar, the applicant states on page 13 of the remarks that the combination of these references does not teach or suggest the claimed closed-loop intraoperative update in which:
The MRI imaging device operates with the instrument-borne micro-coil to acquire a subsequent MRI image during the intervention;
The tractography-based surgical plan is updated based on that subsequent MRI image; and
The updated plan is provided to the guidance module during the same intervention.
It is initially noted that Simon alone was described on page 2-3 of the previous Office action’s Response to Arguments section in how it is interpreted to read on the supposed deficiencies of the second and third bullets above. Additionally, Simon teaches that “One skilled in the art will understand that the tract and confidence factor information can be determined pre-operatively or intra-operatively. Thus the system 120 can be substantially a planning system, a navigation system, or combinations thereof” (see paragraph 76). And “It will be understood, therefore, that the processing and the confidence system 120 can be performed at any appropriate location and at any appropriate time such as pre-operatively, intra-operatively, or post-operatively” (see paragraph 85). Therefore, the examiner does not agree that a closed-loop system is not taught by Simon.
However, in order to expedite prosecution, additional prior art is incorporated into the rejections of the independent claims to illustrate additional prior art that teaches these aspects.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (any paragraphs cited come from PGPUB 2024/0090949, representative of the specification of the instant application):
Claim 1
A planning module configured to determine…
This limitation utilizes the generic placeholder “module”, transitional phrase “configured to” and functional language “determine”. The preceding term “planning” does not apply specific structure that performs the function.
The specification states the following in paragraphs 8 and 32 that this system is a software package.
A guidance module configured to guide…
This limitation utilizes the generic placeholder “module”, transitional phrase “configured to” and functional language “guide”. The preceding term “guidance” does not apply specific structure that performs the function.
The specification states the following in paragraphs 8 and 32 that this system is a software package.
A control module configured to: receive…, provide…, etc. … update
This limitation utilizes the generic placeholder “module”, transitional phrase “configured to” and functional language of “receive”, “provide” and “update”. The preceding term “control” does not apply specific structure that performs the function.
The specification states the following in paragraphs 8 and 32 that this system is a software package.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 21-22, 28, 31-33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Simon (US Patent Pub. No. 2009/0232374) in view of Karmarkar et al. (WO 2007/064739), in view of Thomas et al. (US Patent Pub. No. 2016/0070436).
Regarding claim 1, Simon discloses an integrated system for supporting minimally invasive surgery, the system comprising:
an MRI imaging device (see numeral 26 in Figure 1, see paragraphs 18-19);
a planning module configured to determine a tractography-based surgical plan from at least one initial MRI image of anatomy (see “surgical planning” block 138 in Figure 2, from which data is obtained via “imaging and diffusion data acquisition” block 122 and through confidence building or determining sub-routine” block 128 – see at least paragraph 39 and 48);
a guidance module configured to guide a medical instrument during an ongoing surgical intervention according to the tractography-based surgical plan (see “navigate surgical procedure” block 140 and at least paragraph 49);
the medical instrument (see paragraph 20, which lists potential surgical instruments that may be used including deep brain stimulators) …;
a control module (see processor system 40 in Figure 1), configurable by a set of executable instructions stored in a non-transitory memory (see memory 46 in Figure 1), the control module configured to (note that Figure 2 illustrates a visualization or tractography confidence system 120, where “The confidence system 120 can include or be defined by algorithms to process data with the processor system 40” – see paragraph 35):
receive at least one initial MRI image from the MRI imaging device (see block 122 through block 126 of Figure 2);
provide the at least one initial MRI image to the planning module (see blocks 126 – 138);
receive the tractography-based surgical plan by the planning module (see block 138);
provide the tractography-based surgical plan to the guidance module (see line connecting block 138 to block 140);
receive, from the MRI imaging device during the ongoing surgical intervention, at least one subsequent MRI image of the medical instrument in relation to the anatomy (see paragraph 24 of Simon, “the controller 34 can be used intra- or pre-operatively to control and obtain image data of the patient 28” and paragraph 29 teaches that image data of a brain of a patient can be obtained and used “for viewing during the procedure and navigating the instrument 24 relative to the image data 23. Further, the acquired image data can be used to plan the movement of the instrument 24 or for positioning of an implant during an operative procedure.”).
However, Simon does not teach (1) wherein at least one MRI micro-coil is embedded within or affixed to the medical instrument, (2) that the subsequent MRI images are images of the medical instrument directly (although this is implied based on the quotes from paragraphs 24 and 29 above), (3) that an MRI micro-coil is embedded in or affixed to the instrument, nor (4) update the tractography-based surgical plan based on the at least one subsequent MRI image and provide the updated tractography-based surgical plant to the guidance module during the ongoing surgical intervention (although this is implied by Simon in paragraph 76 and 85 as indicated in the Response to Arguments section).
Karmarkar teaches “MRI compatible localization and/or guidance systems for facilitating placement of an interventional therapy and/or device in vivo” (see Abstract), and specifically “to placement/localization of interventional medical devices and/or therapies in the body… for placing neuro-modulation leads, such as Deep Brain Stimulation ("DBS") leads” (see Field of the Invention). Karmarkar teaches that “the targeting … probe or components thereof may be MRI visible” and “The probe may hold a recording and a stimulating electrode. The probe and/or sheath can be MRI active (include MRI imaging coils and/or cooperate with other components to define an MRI antenna)” (see page 2, line 28 through page 3, line 9). “The elongate probe 30 can be MRI-visible and may optionally be configured to define an MRI antenna. The system 10 can be configured to allow for real-time tracking under MRI, with an SNR imaging improvement in a diameter of at least 5-10 mm proximate the probe 30 or cannula 20” (see page 16, lines 13-16), which teaches the #1 and #2 deficiencies of Simon. Additionally, Karmarkar teaches that “the progress of the cannula 20 and/or interventional probe 30 may optionally be tracked in substantially real-time as it advances to the target via the coils 21, 22 (similar ones of which may also or alternatively be on or in probe 30) and/or antenna 30a” (see page 16, lines 17-31), which also teaches the #2 deficiency of Simon. Additionally, it is noted that Karmarkar teaches that “the interventional tools can be configured to facilitate high resolution imaging via integral imaging coils” (see page 13, lines 27-28); which provides further evidence that the probe is within the MR imaging field of view during the imaging of the patient’s anatomy. Additionally, Karmarkar teaches that “as shown for example in Figure IB, the probe 30 comprises an MRI antenna 30a that is configured to pick-up MRI signals in local tissue during an MRI procedure. The MRI antenna 30a can be configured to reside on the distal portion of the probe 30” (see page 20, lines 6-9), with teaches deficiency #3 of Simon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize micro-coils on the probe and image via MR in real-time, as taught by Karmarkar, within the system and methods Simon. By doing so, this could eliminate the need for a separate electromagnetic tracking system and the processing of such tracking data to register the coordinate systems of the tracking system with those of the MR images, since the MR images themselves will have all of the data and information necessary to 3D tracking in real-time, and by doing so can then direct the MR system to change the acquired imaging plane (“the system 10 can be configured to identify and provide 3D coordinates of one or more of the elongate member, the target, the burr hole location, etc. in the MRI space. This data can direct which imaging plane to use to observe the probe and/or access path trajectory or direct the operator to prescribe the imaging plane on the scanner” – 31, lines 4-20) for improved guidance.
While Simon teaches that “One skilled in the art will understand that the tract and confidence factor information can be determined pre-operatively or intra-operatively. Thus the system 120 can be substantially a planning system, a navigation system, or combinations thereof” (see paragraph 76), and “It will be understood, therefore, that the processing and the confidence system 120 can be performed at any appropriate location and at any appropriate time such as pre-operatively, intra-operatively, or post-operatively” (see paragraph 85); Simon does not explicit state that this intra-operative performance of the tract and confidence information would update the surgical plan intra-operatively.
Thomas teaches “planning, navigation and simulation systems and methods for minimally invasive therapy in which the planning method and system uses patient specific pre-operative images” (see Abstract). “In some embodiments the systems and methods can include use of tractography” (see paragraph 52). “In some embodiments, the systems and methods may include data inputs including but not limited to MRI… In an embodiment where the present invention is used in an intra-operative setting, to set or update a surgical path, data inputs may include examples from the above imaging” (see paragraph 76). Additionally, paragraphs 141-142 states the following:
The embodiment of FIG. 2 provides a user, such as a surgeon, with a unified means of navigating through a surgical region by utilizing pre-operative data input(s) and updated intra-operative data input(s). The processor(s) of system and methods are programmed with instructions/algorithms 11 to analyze pre-operative data input(s) and intra-operative data input(s) to update surgical plans during the course of surgery. For example, if intra-operative input(s) in the form of newly acquired images identified a previously unknown nerve bundle or brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery to avoid contacting the nerve bundle.
In some embodiments, the system and methods of FIG. 2 may provide continuously updated intra-operative input(s) in the context of a specific surgical procedure by means of intraoperative imaging sensor(s) to validate tissue position, update tissue imaging after tumor resection and update surgical device position during surgery.
Of emphasis, paragraph 141 states “if intra-operative input(s) in the form of newly acquired images identified a previously unknown …brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery”. It is clear that a newly acquired image identifying a previously unknown brain tract would utilize tractography in order to identify said previously unknown brain tract. Additionally, this passage explicitly states that this would then “be used to update the surgical plan during surgery”. Additionally, paragraph 142 states that intra-operative imaging sensors may be used to continuously update surgical device position during surgery, which implies to image the surgical instrument intra-operative and update its position, which again relates to the #2 deficiency of Simon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide intra-operative imaging, as taught by both Simon and Thomas, to “update the surgical plan during surgery” as stated by Thomas when “a previously unknown …brain tract” is identified via the tractography techniques taught by both Simon and Thomas, in order “to avoid contacting the nerve bundle” (see paragraph 141 of Thomas).
Regarding claim 21, Karmarkar teaches that “as shown for example in Figure 1B, the probe 30 comprises an MRI antenna 30a that is configured to pick-up MRI signals in local tissue during an MRI procedure. The MRI antenna 30a can be configured to reside on the distal portion of the probe 30” (see page 20, lines 6-16).
Regarding claim 22, Simon teaches that “One skilled in the art will understand that the tract and confidence factor information can be determined pre-operatively or intra-operatively. Thus, the system 120 can be substantially a planning system, a navigation system, or combinations thereof”. As illustrated in Figure 2 of Simon, the tract and confidence factor information block 128 requires image and diffusion data acquisition, pre-processing of image data and visualize image data (i.e., blocks 122-126) as input. If this is performed intra-operatively with old, pre-operative image data, this would not provide safe and reliable data. Therefore, this alone would teach one of ordinary skill in the art that this is intra-operative data. Secondly, Thomas explicitly teaches “intra-operative input(s) in the form of newly acquired images identified a previously unknown nerve bundle or brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery” (see paragraph 141). Finally, the instrument taught by Karmarkar having an MRI antenna thereon is clearly and explicitly configured that way to be visible within MR images, and by the combination of Karmarkar with Simon and Thomas, the intra-operative images would obviously include the medical instrument therein.
Regarding claim 28, Simon teaches that “the navigation system 20 can be used to navigate or track instruments including: … deep brain stimulators, electrical leads, etc.” (see paragraph 20). Also see the last sentence of paragraph 83 and paragraph 92 (e.g. “This can allow for guiding a selected instrument, such as a deep brain stimulation probe, relative to a selected region”). It is noted that Karmarkar also teaches DBS throughout.
Regarding claim 31, it is noted that Figure 4 of Simon illustrates an example image displayed on a monitor, in which the brain anatomy is illustrated along with tracts 151a and 152a, probe icon 24i and target location icon 160i, among other features. Also, Thomas teaches that “the system may provide for overlays of veins, viable grey matter, and arteries, presented relative to an approach. From this information, the impact of an approach can be better assessed. For instance, the system may calculate the total volume, or number, or length of fiber tracts that may intersect the port at a given point, or along a given trajectory” (see paragraph 177). Additionally, Thomas teaches that “Other methods for visualizing patient imaging volumes and overlaying DTI information and displaying virtual surgical tools against 3D renderings of 3D sulcal surface maps, or other 3D imaged patient anatomy, will now occur to a person of skill in the art and are contemplated (see paragraph 206). Also, it is noted that “to adjust a placement trajectory for the medical instrument” is intended use of the “integration” that the planning module is configured to perform.
Regarding claims 32-33, Simon teaches a method comprising:
receiving, from an MRI imaging device, at least one initial MRI image (see block 122 through block 126 of Figure 2);
determine, by a planning module, a tractography-based surgical plan from the at least one initial MRI (see “surgical planning” block 138 in Figure 2, from which data is obtained via “imaging and diffusion data acquisition” block 122 and through confidence building or determining sub-routine” block 128 – see at least paragraph 39 and 48);
guiding a medical instrument according to the tractography-based surgical plan during an ongoing surgical intervention (see “navigate surgical procedure” block 140 and at least paragraph 49; see paragraph 20, which lists potential surgical instruments that may be used including deep brain stimulators) …;
during the guiding, acquiring… at least one subsequent MRI image of the medical instrument in relation to the anatomy (see paragraph 24 of Simon, “the controller 34 can be used intra- or pre-operatively to control and obtain image data of the patient 28” and paragraph 29 teaches that image data of a brain of a patient can be obtained and used “for viewing during the procedure and navigating the instrument 24 relative to the image data 23. Further, the acquired image data can be used to plan the movement of the instrument 24 or for positioning of an implant during an operative procedure.”).
However, Simon does not teach (1) wherein at least one MRI micro-coil is embedded within or affixed to the medical instrument, (2) that the subsequent MRI images are images of the medical instrument directly (although this is implied based on the quotes from paragraphs 24 and 29 above), (3) that an MRI micro-coil is embedded in or affixed to the instrument, nor (4) update the tractography-based surgical plan based on the at least one subsequent MRI image and provide the updated tractography-based surgical plant to the guidance module during the ongoing surgical intervention (although this is implied by Simon in paragraph 76 and 85 as indicated in the Response to Arguments section).
Karmarkar teaches “MRI compatible localization and/or guidance systems for facilitating placement of an interventional therapy and/or device in vivo” (see Abstract), and specifically “to placement/localization of interventional medical devices and/or therapies in the body… for placing neuro-modulation leads, such as Deep Brain Stimulation ("DBS") leads” (see Field of the Invention). Karmarkar teaches that “the targeting … probe or components thereof may be MRI visible” and “The probe may hold a recording and a stimulating electrode. The probe and/or sheath can be MRI active (include MRI imaging coils and/or cooperate with other components to define an MRI antenna)” (see page 2, line 28 through page 3, line 9). “The elongate probe 30 can be MRI-visible and may optionally be configured to define an MRI antenna. The system 10 can be configured to allow for real-time tracking under MRI, with an SNR imaging improvement in a diameter of at least 5-10 mm proximate the probe 30 or cannula 20” (see page 16, lines 13-16), which teaches the #1 and #2 deficiencies of Simon. Additionally, Karmarkar teaches that “the progress of the cannula 20 and/or interventional probe 30 may optionally be tracked in substantially real-time as it advances to the target via the coils 21, 22 (similar ones of which may also or alternatively be on or in probe 30) and/or antenna 30a” (see page 16, lines 17-31), which also teaches the #2 deficiency of Simon. Additionally, it is noted that Karmarkar teaches that “the interventional tools can be configured to facilitate high resolution imaging via integral imaging coils” (see page 13, lines 27-28); which provides further evidence that the probe is within the MR imaging field of view during the imaging of the patient’s anatomy. Additionally, Karmarkar teaches that “as shown for example in Figure IB, the probe 30 comprises an MRI antenna 30a that is configured to pick-up MRI signals in local tissue during an MRI procedure. The MRI antenna 30a can be configured to reside on the distal portion of the probe 30” (see page 20, lines 6-9), with teaches deficiency #3 of Simon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize micro-coils on the probe and image via MR in real-time, as taught by Karmarkar, within the system and methods Simon. By doing so, this could eliminate the need for a separate electromagnetic tracking system and the processing of such tracking data to register the coordinate systems of the tracking system with those of the MR images, since the MR images themselves will have all of the data and information necessary to 3D tracking in real-time, and by doing so can then direct the MR system to change the acquired imaging plane (“the system 10 can be configured to identify and provide 3D coordinates of one or more of the elongate member, the target, the burr hole location, etc. in the MRI space. This data can direct which imaging plane to use to observe the probe and/or access path trajectory or direct the operator to prescribe the imaging plane on the scanner” – 31, lines 4-20) for improved guidance.
While Simon teaches that “One skilled in the art will understand that the tract and confidence factor information can be determined pre-operatively or intra-operatively. Thus the system 120 can be substantially a planning system, a navigation system, or combinations thereof” (see paragraph 76), and “It will be understood, therefore, that the processing and the confidence system 120 can be performed at any appropriate location and at any appropriate time such as pre-operatively, intra-operatively, or post-operatively” (see paragraph 85); Simon does not explicit state that this intra-operative performance of the tract and confidence information would update the surgical plan intra-operatively.
Thomas teaches “planning, navigation and simulation systems and methods for minimally invasive therapy in which the planning method and system uses patient specific pre-operative images” (see Abstract). “In some embodiments the systems and methods can include use of tractography” (see paragraph 52). “In some embodiments, the systems and methods may include data inputs including but not limited to MRI… In an embodiment where the present invention is used in an intra-operative setting, to set or update a surgical path, data inputs may include examples from the above imaging” (see paragraph 76). Additionally, paragraphs 141-142 states the following:
The embodiment of FIG. 2 provides a user, such as a surgeon, with a unified means of navigating through a surgical region by utilizing pre-operative data input(s) and updated intra-operative data input(s). The processor(s) of system and methods are programmed with instructions/algorithms 11 to analyze pre-operative data input(s) and intra-operative data input(s) to update surgical plans during the course of surgery. For example, if intra-operative input(s) in the form of newly acquired images identified a previously unknown nerve bundle or brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery to avoid contacting the nerve bundle.
In some embodiments, the system and methods of FIG. 2 may provide continuously updated intra-operative input(s) in the context of a specific surgical procedure by means of intraoperative imaging sensor(s) to validate tissue position, update tissue imaging after tumor resection and update surgical device position during surgery.
Of emphasis, paragraph 141 states “if intra-operative input(s) in the form of newly acquired images identified a previously unknown …brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery”. It is clear that a newly acquired image identifying a previously unknown brain tract would utilize tractography in order to identify said previously unknown brain tract. Additionally, this passage explicitly states that this would then “be used to update the surgical plan during surgery”. Additionally, paragraph 142 states that intra-operative imaging sensors may be used to continuously update surgical device position during surgery, which implies to image the surgical instrument intra-operative and update its position, which again relates to the #2 deficiency of Simon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide intra-operative imaging, as taught by both Simon and Thomas, to “update the surgical plan during surgery” as stated by Thomas when “a previously unknown …brain tract” is identified via the tractography techniques taught by both Simon and Thomas, in order “to avoid contacting the nerve bundle” (see paragraph 141 of Thomas).
Regarding claim 35, Simon teaches that “the navigation system 20 can be used to navigate or track instruments including: … deep brain stimulators, electrical leads, etc.” (see paragraph 20). Also see the last sentence of paragraph 83 and paragraph 92 (e.g. “This can allow for guiding a selected instrument, such as a deep brain stimulation probe, relative to a selected region”). It is noted that Karmarkar also teaches DBS throughout.
Claims 23 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Karmarkar and Thomas as applied to claims 1 and 32 above, and further in view of Gattani et al. (US Patent Pub. No. 2008/0097165).
Simon in combination with Karmarkar and Thomas is described above with regard to claims 1 and 32. In paragraph 141, Thomas teaches “if intra-operative input(s) in the form of newly acquired images identified a previously unknown …brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery”. And Thomas also states that “One disadvantage of current systems, however, is that this information regarding tumor location and trajectory can typically not be modified or interacted with in the surgical suite, resulting in limited utility of this detailed information if additional information during the surgery comes to light, for instance the location of a vessel or critical structure in conflict with the pre-selected trajectory. There is therefore a need for a system that provides real-time surgical procedure planning correction” (see paragraph 19). However, there is no clear statement in Thomas that a pre-selected trajectory is updated in response to a detected deviation of the medical instrument.
Gattani teaches “a method and corresponding system for calculating an optimum surgical trajectory or path for displacing a surgical instrument through the interior of the body of a patient (see Abstract). Specifically, Gattani teaches that “In a manner similar to a vehicle navigation system, if the surgeon deviates from the proposed trajectory, the system 400 will determine and propose a new optimum trajectory for reaching the target position from the current location of the instrument 112. Specifically, as the surgeon displaces the instrument 112 within the body 102 of the patient, the system 400 will continuously determine the position and orientation of the instrument 112 and, in real time, update and propose the most optimum trajectory to reach the designated target from the current location of the instrument 112” (see paragraph 98).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to update the trajectory of the surgical path/plan, thereby updating the surgical path, from the current location of the instrument, as taught by Gattani, and use this in the system and methods of Simon as combined with Karmarkar and Thomas, because Thomas essentially states that that when there is a conflict with the pre-selected trajectory, there is a need for real-time surgical procedure planning correction, but fails to teach when that conflict is a misplacement of the instrument from the path, which is one possible conflict amongst many. Additionally, this will allow a surgeon to safely and efficiently navigate within the body of the patient (see paragraph 99 of Gattani).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Karmarkar and Thomas as applied to claim 1 above, and further in view of Barral et al. (US Patent No. 9,833,254).
Simon in combination with Karmarkar and Thomas is described above with regard to claim 1. While Thomas teaches that “in some embodiments, the system and method may include robotic or semi-robotic manipulators”, there is not a detailed description of how robotics would work with the plan and updated plans of the combination of references.
Barral teaches a robotic surgical system includes a surgical instrument (see Abstract). Figure 1A illustrates robotic arm 120 holding the surgical end effector 110, which is a surgical laser, but column 1, lines 23-26 teach that surgical robots can utilize all sorts of other surgical instruments. In one example, Barral teaches that “the robotic surgical system could, while controlling the surgical instrument to make the initial cut, receive a plurality of images of the biological tissue over time (e.g., at a high frequency, e.g., 10s to 100s of Hertz) and could responsively update the initial trajectory in response to one or more of the plurality of images. Such imaging and responsive updating could increase the safety and/or accuracy of operation of the robotic surgical system to dissect tissue according to a determined trajectory or other specification by allowing for adaptation of the operation of the robotic surgical system to changes (e.g., translations, deformations) in a target biological tissue in nearly real-time” (see column 20, lines 9-16). Barral teaches that multiple new trajectories could be created in real-time and the robotic system can account for these changes, account for a target tissue, an avoidance tissue, or some other specified contents of a biological tissue based on a correspondence between the subsequent image and some previous image of the biological tissue (e.g., a pre-surgical image, an initial image, a preceding subsequent image) (see column 33, lines 16-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a robotic arm to guide the surgery and to allowing for adaptation of the operation of the robotic surgical system to changes (e.g., translations, deformations) in a target biological tissue in nearly real-time, as taught by Barral, within the system and methods of Simon as combined with Karmarkar and Thomas because “Such imaging and responsive updating could increase the safety and/or accuracy of operation of the robotic surgical system” to perform the surgical procedure (see column 20, lines 14-16).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Karmarkar and Thomas as applied to claim 1 above, and further in view of Dyer et al. (US Patent Pub. No. 2017/0265947).
Simon in combination with Karmarkar and Thomas is described above with regard to claims 1 and 32. In paragraph 141, Thomas teaches “if intra-operative input(s) in the form of newly acquired images identified a previously unknown …brain tract, these input(s) can, if desired, be used to update the surgical plan during surgery”. However, there is no discussion of updating based on a confirmation of target alignment.
Dyer teaches a trajectory guidance alignment system (see Abstract). Figure 12 illustrates an example display of a navigation system which shows an “approach” stage (see paragraph 150, also see Figures 11A-11D, where “approach” 1114 is shown as a step during navigation from a port to a location of a target region requiring surgical intervention). Figure 12 shows “navigation symbol S is rendered at a location relative to the real-time neural image NI, the location of the navigation symbol S corresponding to at least one of a planned trajectory and an updated trajectory. The alignment symbol A is rendered at a location relative to the real-time neural image NI, the location of the alignment symbol A corresponding to real-time data corresponding to movement of a tracked or tracking tool (not shown), such as an access port, a pointer tool, a surgical tool, a stimulation tool, and the like” (see paragraph 151). Paragraph 152 then discusses “when the system 200, using an trajectory alignment system, determines that the tracked tool is aligned within a predetermined, or interactively set, proximity threshold in relation to the planned, or updated, trajectory”, which is the situation in which it is confirmed that the surgical tool is aligned with the target by one of the original, or updated trajectory. When this has been achieved, then the surgical procedure would continue from this timepoint and from this tool location. When this is an updated trajectory, then the navigation would continue from this point, which teaches the claimed limitations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide confirmation of the alignment of the tool and target locations with an updated trajectory and based on updated imagery, as taught by Dyer, and to utilize this in the system and methods of Simon as combined with Karmarkar and Thomas, “the alignment system facilitates performing an “approach” by using a pointer, provides a graphic feature whereby alignment becomes intuitive”, thereby improving the surgeon’s experience and increasing the safety for the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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