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
Response to Arguments
With regard to the applicant’s amendments and response related to the invoking of 35 USC 112(f), it is noted that the amendments to the claims of reciting “comprising one or more processors” is not supported by the specification. Contrary to the applicant’s statements on page 8 of the remarks, the specification fails to teach “processor system 40”, as numeral 40 relates to “a bore” of the MRI device; paragraph 35 of the PGPUB 2024/0090949 (which is the same paragraph 35 of the originally filed specification) discusses Figure 2 which is a screenshot of a display and does not include the sentence “The confidence system 120 can include or be defined by algorithms to process data with the processor system 40”. Additionally, Figure 1, which applicant cites and indicates shows “processor system 40” and “memory 46” merely shows four MR images in four quadrants; there is no illustration of a processor system 40 or memory 46. It is noted that paragraph 49 states that “The system S comprises a control module 310 (FIG. 3), configurable by a set of executable instructions storable in relation to a non-transient memory device (not shown)”, and that this is similarly stated at the top of each of Figures 9-11; however, none of these, nor any other portions of the specification teach a processor. Therefore, the “one or more processors” are rejected below under 35 USC 112(a), and assuming these recitations are removed from the claims since they are not supported by the specification, then 112(f) will remain invoked.
Applicant's arguments filed Juny 28, 2026 with respect to the rejections of the claims under prior art have been fully considered but they are not persuasive.
On page 9 of the remarks, the applicant argues that “Simon does not teach applying the tractography algorithm to intraoperative data” and then states that “The Office Action's own analysis confirms the gap. Discussing Simon, paragraphs 76 and 85, the Office Action states: "Simon does not explicit[ly] state that this intra-operative performance of the tract and confidence information would update the surgical plan intra-operatively." These are two distinct aspects. First with regard to “Simon does not teach applying the tractography algorithm to intraoperative data”, it is noted that Simon teaches “One skilled in the art will understand that the tract and confidence factor information can be determined … intra-operatively. Thus the system 120 can be substantially a planning system, a navigation system, or combinations thereof” (see paragraph 76). This explicitly statement clearly states that Simon teaches applying its tractography algorithm to intra-operative data. Therefore, that argument by the applicant is not persuasive. Secondly, the Office action’s statement that "Simon does not explicit[ly] state that this intra-operative performance of the tract and confidence information would update the surgical plan intra-operatively" is a statement that Simon does not outright state that the intra-operative tractography data would update the surgical plan intra-operatively”. However, it is noted that Simon’s explicit teaching in paragraph 76 that “Thus the system 120 can be substantially a planning system, a navigation system, or combinations thereof” would be obvious to one of ordinary skill in the art that a “combination thereof” with intra-operative data would be a system that plans, then navigates, then intra-operatively plans and navigates; i.e., updates a surgical plan intra-operatively. Again, while the examiner takes the position that this is obviously taught by Simon based on this passage (as well as the passage from paragraph 85 found on page 8 of the previous Office action), the previous Office action explicitly incorporated the Thomas reference for the purposes of intra-operative inputs (i.e., newly acquired images that includes tract information) can “be used to update the surgical plan during surgery”. Hence, the combination of Simon with Thomas teaches the acquiring intra-operative data (taught by both Simon and Thomas), utilizing tractography algorithms on the intra-operative imaging data (taught by both Simon and Thomas) and updating a surgical plan during the surgery with this intra-operative tractography analyzed image data (implied by Simon, explicitly taught by Thomas).
On pages 10-11, the applicant argues that Karmarkar does not make up for the deficiencies described above, because “Karmarkar's contribution, as the Office Action itself frames it, is limited to the physical, MRI-compatible probe/coil hardware (Office Action at 6-7, 12); it cannot, and the Office Action does not contend that it does, supply the tractography-algorithm-based update step now recited in claim 1.” The examiner agrees with this characterization.
On pages 11, the applicant argues that “Thomas's conditional, generic disclosure does not teach applying the tractography algorithm to a micro-coil-acquired image.” The examiner notes that Thomas is incorporated to teach the use of intra-operative imaging data, which is subjected to tractography analysis, is used for updating a surgical plan during the surgery. Thomas is not, and does not need to teach, “applying the tractography algorithm to a micro-coil-acquired image”. (1) The micro-coil aspect of the claims are covered by the incorporation of Kamarkar and the Thomas reference was never incorporated to teach this, and (2) the claims does not recite “applying the tractography algorithm to a micro-coil-acquired image”. Instead, the claims recite that subsequent MRI image(s) of the medical instrument in relation to the anatomy are acquired while the MRI imaging device operates with the at least one MRI micro-coil embedded within or affixed to the medical instrument. In other words, the subsequent MR image(s) acquires images during the surgical intervention, during which time the surgical instrument is within the patient and obviously then, the instrument is within the images along with the patient anatomy and visible within the image. There is no claim limitation that states that there is a “micro-coil-acquired image”. Therefore, this argument is not persuasive.
On page 11, the applicant states that “Three distinctions are decisive. First, Thomas's update is expressly conditional ("if desired") and tied to the specific contingency that a previously unknown anatomical structure happens to be revealed; it is not disclosed as a routine, closed-loop step performed on every subsequent MRI image acquired through the guided instrument's own micro-coil, as amended claim 1 requires.” Firstly, as explained above, the claims do not recite any “subsequent MRI image acquired through the guided instrument's own micro-coil.” Therefore, that portion of this argument is not persuasive. Secondly, the argument that Thomas’ update is conditional and tied to a specific contingency is not persuasive. Thomas explicitly teaches “The processor(s) of system and methods are programmed with instructions/algorithms 11 to analyze pre-operative data input(s) and intraoperative data input(s) to update surgical plans during the course of surgery.” This is not a contingency. This sentence if then followed with an example, in which it states that one situation which would warrant such updated surgical plan would be the identifying of a previously unknown nerve bundle or brain tract, and it states that these can be used to update the surgical plan during surgery to avoid contacting the nerve bundle. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that this exemplary situation would be desirable by a surgeon. If a previously unknown nerve bundle was discovered intra-operatively and represented a nerve bundle that needed to be avoided, then this would obviously be updated within the planning/navigation system intra-operatively. To state that this would be disregarded is not a decision that would be made by one of ordinary skill in the art.
On page 11, the applicant argues that “Second, Thomas … states only that, in an intraoperative setting, ‘data inputs may include examples from the above imaging’, a generic reference to imaging data, not to an image acquired specifically through an MRI micro-coil embedded within or affixed to the medical instrument being guided’”. Again, this (i.e., an image acquired specifically through an MRI micro-coil embedded within or affixed to the medical instrument) is not recited in the claims, and therefore it not a requirement of any reference.
On page 12, the applicant argues that “Third, Because Thomas nowhere discloses applying a tractography algorithm to a subsequently acquired MRI image obtained through an instrument-borne micro-coil, and because Simon's own confidence-system processing is, by the Examiner's own admission, not expressly tied to updating the surgical plan intraoperatively, the combination of Simon, Karmarkar, and Thomas does not teach or suggest the amended limitation that the planning module updates the tractography-based surgical plan "by applying the tractography algorithm to the at least one subsequent MRI image." The examiner respectfully disagrees with this assessment. As described above, the claims do not require “a subsequently acquired MRI image obtained through an instrument-borne micro-coil”. Therefore, the claims do not require a tractography algorithm to be applied to this specific type of MR image. Next, it has been addressed above that Simon explicitly teaches to use its tractography algorithm on intra-operative image data, and Simon implies that this will be used to update the surgical plan and intra-operative navigation; while Thomas, as explained above, explicitly teaches updating a surgical plan intra-operatively with intra-operative image data that has been analyzed with tractography algorithms. Therefore, this argument is not persuasive.
On page 13, the applicant argues that “the Office Action does not articulate, and none of the three references suggest, any reason a person of ordinary skill in the art would have gone further and re-executed the tractography algorithm itself on the newly acquired, micro-coil-derived image, rather than simply flagging that the plan should be updated in some unspecified manner.” Once again, the claims fail to recite that there is any “newly acquired, micro-coil-derived image”, which means that there is no claim recitation of “re-executed the tractography algorithm itself on” such an image. Further, the combination of Simon with Thomas presents the teaching of updating a surgical plan intra-operatively with newly acquired MR images based on tractography analysis. Therefore, this is all taught. Finally, motivation is provided for each additional reference. Applicant’s argument fails to refute any actual motivation statement provided in the previous Office action, and fails to point out any faults in such motivation statements. Instead, this argument simply states "no motivation has been provided". The examiner respectfully disagrees with this argument, and the motivation is clearly articulated in the previous Office action.
On page 14, the applicant argues “Gattani's trajectory revision is a generic geometric path recalculation keyed to tracked instrument position; it has nothing to do with MRI imaging, diffusion data, tractography, or an instrument-borne micro-coil, and Gattani does not disclose or suggest applying a tractography algorithm to any MRI image.” First, Gattani teaches that its surgical trajectory determination system 100 uses volumetric data, which is stated as being any one of “CT scan, PET scan, MRI, etc.” (see paragraph 76 and 78 of Gattani, noting also that paragraph 86 also teaches the techniques “can be utilized during the performance of an actual surgical procedure”); therefore Gattani does teach the use of MR imaging. Second, Gattani is not taught specifically for diffusion data, tractography, nor an instrument-borne micro-coil, nor applying a tractography algorithm to MR images. Those claim aspects are taught by the previously discussed references. Gattani is teaches updating a surgical plan where the updating comprises “to update a trajectory in response to a detected deviation of the medical instrument from the … surgical plan.” Whether or not that original surgical plan is based on a tractography algorithm or not has no bearing on a teaching to update a planned trajectory with a new trajectory. The claims do not require that the new trajectory be determined via the use of a tractography algorithm, and the specification does not support, specifically, that a tractography algorithm results in a trajectory to be determined. The word trajectory appears four times in the specification (i.e., in paragraphs 15, 35 and 37 of the PGPUB of the instant application), and all simply relate to Figure 2 which does not show any processor related steps that create the trajectory. Therefore, the teachings of Gattani are sufficient to teach the claims and what is actually supported in the specification.
On page 14, the applicant argues that “Barral's disclosure is again a generic, image-comparison-based trajectory correction for a robotically held surgical laser - it discloses no MRI imaging device, no tractography algorithm, and no MRI micro-coil.” The examiner respectfully disagrees that this is relevant. Specifically, claims 25 and 26, for which Barral was incorporated, recites a robotic arm that positions the medical instrument according to a surgical plan. In the claim, the surgical plan is the earlier claimed “updated tractography-based surgical plan”. However, the robotic arm does not determine this plan, nor does the robotic arm perform MR imaging techniques or analyze MRI data. The Office action does not present Barral as a prior art reference under 35 USC 102, but is a reference utilized under 35 USC 103 to provide additional teachings to the aspects of the claim that are further narrowing. Barral, in combination with the references previously described reads on claims 25 and 26. The applicant’s arguments are not persuasive.
On page 15, the applicant argues that “Dyer's alignment-confirmation graphic is keyed to conventional tool tracking (e.g., an access port, pointer tool, or stimulation tool); Dyer does not disclose that the "updated ... trajectory" it displays is itself derived by applying a tractography algorithm to an MRI image acquired through an instrument-borne micro-coil.” Again, the examiner respectfully disagrees that this is relevant. Specifically, claim 29, for which Dyer was incorporated, recites that the control module only updates the guidance module with an updated surgical plan after confirming target alignment based on the at least one subsequent MR image, where that updated surgical plan is a tractography-based plan. In the claim, the surgical plan is the earlier claimed “updated tractography-based surgical plan” which is taught by Simon and Thomas. However, the function of the control module to require confirmation before sending data to the guidance module does not determine this plan, nor does it perform MR imaging techniques or analyze MRI data. The Office action does not present Dyer as a prior art reference under 35 USC 102, but is a reference utilized under 35 USC 103 to provide additional teachings to the aspects of the claim that are further narrowing. Dyer, in combination with the references previously described reads on claim 29. The applicant’s arguments are not persuasive.
For at least the reasons presented above, the arguments are not persuasive and the following rejections apply.
Claim Objections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Cancelled claims 2-20 must be provided within the listing of claims and indicated with claim identifier “Cancelled”.
Claims 1, 21-23, 25-26, 28-29 and 31-35 are objected to because any and all recitations of “MRI imaging”, or the like, is redundant because “MRI” stands for “magnetic resonance imaging”. As such, this phrase in whole states “magnetic resonance imaging imaging”.
Claim Rejections - 35 USC § 112
First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 21-23, 25-26, 28-29, 31 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “one or more processors”, which is not supported by the application’s disclosure. Although applicant states in the response dated July 28, 2026 that the application discloses a processor system 40, the specification fails to teach “processor system 40”, as numeral 40 relates to “a bore” of the MRI device; paragraph 35 of the PGPUB 2024/0090949 (which is the same paragraph 35 of the originally filed specification) discusses Figure 2 which is a screenshot of a display and does not include the sentence “The confidence system 120 can include or be defined by algorithms to process data with the processor system 40”. Additionally, Figure 1, which applicant cites and indicates shows “processor system 40” and “memory 46” merely shows four MR images in four quadrants; there is no illustration of a processor system 40 or memory 46. It is noted that paragraph 49 states that “The system S comprises a control module 310 (FIG. 3), configurable by a set of executable instructions storable in relation to a non-transient memory device (not shown)”, and that this is similarly stated at the top of each of Figures 9-11; however, none of these, nor any other portions of the specification teach a processor.
Claims 21-23, 25-26, 28-29 and 31 are rejected for their dependency from claim 1, thereby incorporating the same issues.
Claim 34 recites “applying the tractography algorithm to update a trajectory”. However, the specification fails to teach that the tractography algorithm is used in the updating of a trajectory. The word trajectory appears four times in the specification (i.e., in paragraphs 15, 35 and 37 of the PGPUB of the instant application), and all simply relate to Figure 2 which does not show any processor related steps that create the trajectory. There is no teaching that the tractography algorithm results in a trajectory.
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 that utilizes “separate or individual processors” (see paragraph 27; and memory 46, see Figure 1) 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 by applying a tractography algorithm to 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.”);
provide the at least one subsequent MRI image to the planning module, the planning module further configured to update the tractography-based surgical plan by applying the tractography algorithm to the at least one subsequent MRI image, whereby an updated tractography-based surgical plan is generated (see paragraph 76, “One skilled in the art will understand that the tract and confidence factor information can be determined pre-operatively or intra-operatively” and a similar quote found in the last sentence of paragraph 85; also paragraph 22 states that “The navigation system 20 can include the optional imaging device 26 that is used to acquire … intra- …-operative or real-time image data of a patient 28 with additionally similar quote in paragraph 24; these teachings would therefore indicate that there could optionally be a dashed line from box 140 “Navigate Surgical Procedure” back up to box 122 “imaging and diffusion data acquisition”, such that the process can be a full loop).
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 an explicit teaching of (4) receive the updated tractography-based surgical plan from the planning module and provide the updated tractography-based surgical plan to the guidance module during the ongoing surgical intervention (although this is implied by Simon in paragraphs 22, 24, 76 and 85 as indicated in the immediately preceding paragraph above).
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, although the teachings of paragraphs 22, 24, 76 and 85 of Simon would therefore imply that there could optionally be a dashed line from box 140 “Navigate Surgical Procedure” back up to box 122 “imaging and diffusion data acquisition”, such that the process can be a full loop, but to further prosecution the following reference is incorporated.
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 by applying a tractography algorithm to 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.”);
updating, by the planning module, the tractography-based surgical plan by applying the tractography algorithm to the at least one subsequent MRI image, whereby an updated tractography-based surgical plan is generated (see paragraph 76, “One skilled in the art will understand that the tract and confidence factor information can be determined pre-operatively or intra-operatively” and a similar quote found in the last sentence of paragraph 85; also paragraph 22 states that “The navigation system 20 can include the optional imaging device 26 that is used to acquire … intra- …-operative or real-time image data of a patient 28 with additionally similar quote in paragraph 24; these teachings would therefore indicate that there could optionally be a dashed line from box 140 “Navigate Surgical Procedure” back up to box 122 “imaging and diffusion data acquisition”, such that the process can be a full loop).
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) providing the updated tractography-based surgical plan for guiding the medical instrument during the ongoing surgical intervention (although this is implied by Simon in paragraphs 22, 24, 76 and 85 as indicated in the immediately preceding paragraph above).
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, although the teachings of paragraphs 22, 24, 76 and 85 of Simon would therefore imply that there could optionally be a dashed line from box 140 “Navigate Surgical Procedure” back up to box 122 “imaging and diffusion data acquisition”, such that the process can be a full loop, but to further prosecution the following reference is incorporated.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
