DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites “a shifted boundary” but the term was previously recited in line 14 of claim 1 (“receiving an indication of a shifted boundary…”).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “wherein the images the second excision plan is based on indicate boundaries of the targeted tissue portion with adjacent tissue less distinctly than the pre-operative images.” Claim 7 depends from claim 6.
First, Examiner suspects that the term “the images” is modified by the subsequent clause “the second excision plan is based on.” However, the clause is not introduced by “that” or “which.” If that is the case, a more direct statement that the second excision plan is based on the images will make the claim clearer.
Second, the phrase “less distinctly than the pre-operative images” is relative and one skilled in the art would not understand what is claimed even in light of the specification. (MPEP 2173.05). The term “less distinctly” is not used in the specification other than to repeat the claim language of claim 7 in paragraph [0012]. The phrase “may or may not be unambiguously distinct” is used at [0140] to describe the boundary region in intraoperative images, but this description does not help better understand the scope of claim 7. Examiner suspects that the meaning of “less distinctly” relates to contrast/resolution of the imaging modality used intraoperatively (see, e.g., [0086], [0137]) but the disclosure also describes the content of the images providing greater contrast. (see, e.g., [0104], [0105]).
For the purpose of compact prosecution, Examiner is interpreting claim 7 as follows:
“wherein the second excision plan is based on the images, and wherein pre-operative images have at least one of a higher resolution or greater contrast than the images of the second excision plan.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 8, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”).
With respect to claim 1, SHELTON discloses a method of guiding a robotically controlled surgical tool to excise a targeted tissue portion within neural tissue. ([0003]; see also [0130]). “The surgical device 102 can be any suitable surgical device such as, for example, a dissector, a stapler, a grasper, a clip applier, and/or an energy device including mono-polar probes, bi-polar probes, ablation probes, and/or an ultrasonic end effector.” ([0153]).
The method comprising receiving a first excision plan specifying a first working volume of the targeted tissue portion. “The process 4150 identifies 4151 an anatomical organ targeted by the surgical procedure, identifies 4152 anatomical structures of the anatomical organ which are relevant to the surgical procedure, and proposes 4153 surgical resection paths [i.e., first excision plan] for removing a portion of the anatomical organ by the surgical instrument....” ([0356]). SHELTON also discloses excising targeted tissue with the surgical tool with movements limited to within the first working volume according to the
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first excision plan. “FIG. 32C illustrates a live view 4201′ of the surgical field on the screen 4230 of the visualization system at a later time (00:43). An end effector 4202 of the surgical instrument 4200 resects tissue along the predefined resection path defined by the layout plan 4209.” ([0360]). SHELTON also discloses before the targeted tissue portion is fully excised: imaging the targeted tissue portion in its incomplete excised state, generating a second excision plan defining a second working volume, based on the imaging. “A volume change of tissue including the region 4203 due tissue inflammation, for example, causes critical structures 4206 and 4208 to be shifted into the predefined resection path. In response, the control circuit proposes an alternative resection path 4210 [i.e., second excision plan] that navigates around the critical structures 4206, 4208, which protects the critical structures 4206, 4208 from being damaged, as illustrated in FIG. 32D.” ([0360]). SHELTON also discloses continuing excision with the surgical tool according to the second excision plan, and while limited to the second working volume. See, e.g., Figure 32D that is captioned “User starts cut here causing inflammation or trauma resulting in critical structures shifting to original cut Re-direct/Re-route user to optimize cut path based on changes.” SHELTON also discloses wherein generating the second excision plan comprises: receiving an indication of a shifted boundary of the targeted tissue portion, and defining the second working volume within the targeted tissue portion, based on the indication of the shifted boundary. “For instance, the tissue resection process can sometimes lead to tissue inflammation that changes the tissue shape and/or volume, which can cause a critical structure (e.g. a blood vessel) to shift position. Dynamic visualization data enable the control circuit to detect position and/or volume changes of critical structures and/or relevant anatomical structure near a set resection path. If the changes in position and/or volume cause the critical structures to shift into, or within a safe margin from, the resection path, the control circuit modifies the set resection path by selecting, or at least recommending, an alternative resection path of the surgical instrument.” ([0358]).
With respect to claim 6, SHELTON also discloses wherein the indication of a shifted boundary is derived from images obtained by the imaging. "In at least one example, the control circuit modifies a set resection path (FIG. 32B) for removing a portion of an organ or an abnormality (e.g. a tumor or region) by a surgical instrument to an alternative resection path (FIG. 32D) based on the dynamic visualization data from one or more imaging devices of a visualization system ( e.g. visualization system 100, 160, 500, 2108) tracking progress of the tissue being resected and surrounding tissue." ([0358]). Example imaging devices are described in [0154]-[0157].
With respect to claim 8, SHELTON also discloses wherein the indication of the shifted boundary comprises intraoperatively obtained images of the targeted tissue portion. “In various aspects, the present disclosure provides a surgical visualization system for intraoperative identification and avoidance of critical structures.” ([0135]). (See also [0177]: "The camera 612 receives intraoperative images through optics 632 and the image sensor 634." ([0177])).
With respect to claim 20, SHELTON also discloses wherein the imaging is performed using an ultrasound imager. "The identification of the critical structure 101 can be accomplished through spectral analysis, photo-acoustics, and/or ultrasound, for example." ([0157]).
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 2, 3, 15, 21, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”) and U.S. Patent Appl. Publ. No. 2021/0137612 to Staid et al. (hereinafter “STAID”).
With respect to claim 2, SHELTON does not teach that the first and second excision plans specify automatic motions of the robotically controlled surgical tool within their respective first and second working volumes.
In the same field of endeavor, STAID teaches surgical probes for tissue resection with robotic arms. (Title). STAID in particular teaches a water jet as the “energy source” that removes tissue but suggests various other mechanisms. “The energy source may comprise one or more of a laser beam, a water jet, an electrode, ultrasound, high intensity focused ultrasound, mechanical vibrations, radiofrequency (RF) energy an ultrasound transducer, microwave energy, cavitating energy such as a cavitating water jet or ultrasonic cavitations, radiation such as ionizing radiation from a radioisotope, or ion energy from ionization electrodes or plasma energy from plasma electrodes.” ([0032]).
STAID teaches using a surgical plan that specifies automatic motions of the robotically controlled surgical tool within a working volume. "The tissue can be resected in accordance with a defined tissue resection volume that can be determined based on images of the patient. The probe can be moved to a plurality of positions with movement of a distal end of the robotic arm and tissue resected in accordance with the treatment plan." (emphasis added) ([0005]). “The one or more computing devices operably coupled to the first and second robotic arms may be configured to automatically control the movement of the treatment probe and/or the imaging probe. For example, the robotic arms may be configured to automatically adjust the position and/or orientation of the treatment probe and/or imaging probe during treatment of the patient, according to one or more pre-programmed parameters.” (emphasis added) ([0052]; see also [0062]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON system to use surgical plans that specify automatic motions of a robotically controlled surgical tool within a working volume as taught in STAID. First, SHELTON suggests using automated or semi-automated robotics during surgical procedures. (see, e.g., [0173]: "Various algorithms can be employed to guide robotic automation and semi-automated approaches based on the surgical procedure and proximity to the critical structure(s)."). Second, one would have been motivated to use robotically-controlled arms that operate in accordance with surgical plans because robotically-controlled surgical tools offer more precision and can remove human error. There would have been a reasonable expectation of success because such surgical plans and robotically-controlled arms can be incorporated into image-guided systems.
With respect to claim 3 (depending from claim 2), the combined references of SHELTON-STAID teach the claimed invention and STAID further teaches wherein the automatic motion of the surgical tool is performed according to a progressive cutting pattern.
Specifically, STAID teaches that a “tissue resection profile 700 can be generated with instructions on the processor to move the tissue in a scanning pattern 702 by moving the proximal end of the robotic arm to move the tip of the probe and water jet to appropriate locations about the resection boundary 704.” (emphasis added) ([0077]). "…in some embodiments tissue is sequentially resected with a plurality of removal layers. For example, a first layer can be removed with tissue resected up to the resection boundary 600, and a second removal layer resected up to a second removal boundary." ([0077]). NOTE: The water jet of STAID is similar to one of the tools described in Applicant’s disclosure: “In some embodiments, the tissue-dissecting portion of the surgical tool comprises an aperture through which energy is applied (e.g., pressure and/or a jetting fluid) to controllably dissect adjacent tissue.” ([0080]).
With respect to claim 15, SHELTON does not explicitly teach wherein the second working volume is defined by one or more 2-D perimeters corresponding to 2-D cross-sections of the targeted tissue portion.
However, STAID teaches that "[i]n some embodiments, the tissue 600 can be resected in a plurality of layers of substantially equal depth, in which the probe removes each subsequent layer after the tissue has been resected along the boundary for a prior layer." ([0078]). Each layer constitutes a 2-D cross-section (or perimeter) of the working volume.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON system to use surgical plans that specify that the working volume includes one or more 2-D perimeters corresponding to 2-D cross-sections of the targeted tissue portion. One would have been motivated to define the working volume as a stack of 2-D perimeters (or cross-sections) because STAIN teaches that an effective way to carefully remove tissue is to remove one cross-section (or 2-D perimeter) at a time. There would have been a reasonable expectation of success because such surgical plans and progressive cutting patterns can be incorporated into image-guided systems.
With respect to claim 21, SHELTON does not explicitly teach that the excising proceeds through a series of layers, stacked along a longitudinal axis of the surgical tool.
However, STAID teaches that “[i]n some embodiments, the water jet is directed out the end of the probe aligned with the axis of the probe, e.g. substantially straight. The proximal end of the probe can be translated and rotate to provide resection along the three-dimensional tissue resection boundary 704. In some embodiments, the tissue 600 can be resected in a plurality of layers of substantially equal depth, in which the probe removes each subsequent layer after the tissue has been resected along the boundary for a prior layer.” (emphasis added) ([0078]).
With respect to claim 24, SHELTON teaches a system for automatic excision of a tissue portion within neural tissue, the system comprising. ([0003]; see also [0130]). The system includes a robotically operated surgical tool (see, e.g., the “surgical instrument 4200” described at [0360]) and a robotic controller (see, e.g., the “control circuit” described at [0357] and [0173]) configured to: receive an excision plan comprising a defined working volume. “The process 4150 identifies 4151 an anatomical organ targeted by the surgical procedure, identifies 4152 anatomical structures of the anatomical organ which are relevant to the surgical procedure, and proposes 4153 surgical resection paths [i.e., first excision plan] for removing a portion of the anatomical organ by the surgical instrument....” ([0356]). SHELTON also teaches operating the surgical tool to excise tissue within the working volume. “FIG. 32C illustrates a live view 4201′ of the surgical field on the screen 4230 of the visualization system at a later time (00:43). An end effector 4202 of the surgical instrument 4200 resects tissue along the predefined resection path defined by the layout plan 4209.” ([0360]). SHELTON also teaches an imager, operable to obtain images of the tissue portion during operation of the surgical tool to excise tissue. "In at least one example, the control circuit modifies a set resection path (FIG. 32B) for removing a portion of an organ or an abnormality (e.g. a tumor or region) by a surgical instrument to an alternative resection path (FIG. 32D) based on the dynamic visualization data from one or more imaging devices of a visualization system (e.g. visualization system 100, 160, 500, 2108) tracking progress of the tissue being resected and surrounding tissue." ([0358]). Example imaging devices are described in [0154]-[0157]. SHELTON also teaches that the controller is configured to provide the robotic controller with the new excision plan to continue automatic operation of the surgical tool to excise tissue within the new working volume. See, e.g., Figure 32D that is captioned “User starts cut here causing inflammation or trauma resulting in critical structures shifting to original cut Re-direct/Re-route user to optimize cut path based on changes.” (see also [0358]: “…the control circuit modifies the set resection path by selecting, or at least recommending, an alternative resection path of the surgical instrument.”). SHELTON also teaches that the controller is configured to define, using images obtained with the imager, a changed position of an un-excised fraction of the tissue portion after movement of the un-excised fraction due to operation of the robotically operated surgical tool, and generate, based on the changed position, a new excision plan comprising a new working volume including the un-excised fraction of the tissue portion. “For instance, the tissue resection process can sometimes lead to tissue inflammation that changes the tissue shape and/or volume, which can cause a critical structure (e.g. a blood vessel) to shift position. Dynamic visualization data enable the control circuit to detect position and/or volume changes of critical structures and/or relevant anatomical structure near a set resection path. If the changes in position and/or volume cause the critical structures to shift into, or within a safe margin from, the resection path, the control circuit modifies the set resection path by selecting, or at least recommending, an alternative resection path of the surgical instrument.” ([0358]).
However, SHELTON does not explicitly teach automatically operating the surgical tool to excise tissue within the working volume. However, SHELTON does suggest using automated or semi-automated robotics during surgical procedures. (see, e.g., [0173]: "Various algorithms can be employed to guide robotic automation and semi-automated approaches based on the surgical procedure and proximity to the critical structure(s).").
STAID teaches automatically operating the surgical tool to excise tissue within the working volume according to a surgical plan that specifies the automatic motions. "The tissue can be resected in accordance with a defined tissue resection volume that can be determined based on images of the patient. The probe can be moved to a plurality of positions with movement of a distal end of the robotic arm and tissue resected in accordance with the treatment plan." (emphasis added) ([0005]). “The one or more computing devices operably coupled to the first and second robotic arms may be configured to automatically control the movement of the treatment probe and/or the imaging probe. For example, the robotic arms may be configured to automatically adjust the position and/or orientation of the treatment probe and/or imaging probe during treatment of the patient, according to one or more pre-programmed parameters.” (emphasis added) ([0052]; see also [0062]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON system to use surgical plans that specify automatic motions of a robotically controlled surgical tool within a working volume as taught in STAID. First, SHELTON suggests using automated or semi-automated robotics during surgical procedures. (see, e.g., [0173]: "Various algorithms can be employed to guide robotic automation and semi-automated approaches based on the surgical procedure and proximity to the critical structure(s)."). Second, one would have been motivated to use automatic robotically-controlled surgical tools that operate in accordance with surgical plans because such robotically-controlled surgical tools offer more precision and can remove human error. There would have been a reasonable expectation of success because such surgical plans and robotically-controlled tools can be incorporated into image-guided systems.
With respect to claim 25, SHELTON teaches that the system comprises a user interface, wherein the target tissue tracker also defines the changed position of the tissue portion using user-generated selections guided by the images obtained with the imager. “In at least one example, a user may select the anatomical structures using any suitable input device.” ([0332]). The user interface is taught by the suitable input device. See also monitors 652a and 652b in Figure 11. “The identified anatomical structures can be anatomical structures in a surgical field and/or anatomical structures are selected by a user. In various examples, position tracking of the relevant anatomical structures can be expanded beyond a current visibility view of a camera directed at the surgical field.” ([0333]).
With respect to claim 26, SHELTON does not explicitly teach the claim limitations. However, STAID teaches that the robotically operated surgical tool comprises a longitudinally extended device having a flexible and steerable tip with a cutting end. “In some embodiments, the deflectable tip 462 comprises a controllable tip in which the amount of deflection 604 can be controlled in response to instructions. For example, the tip 462 may comprise pull wires or other elongate elements that allow the angle of deflection to be controlled, for example in response to one or more of the processor, the user interface, or the user input device.” ([0065]).
It would have been obvious to modify the SHELTON system to include a robotically operated surgical tool that has a longitudinally extended device having a flexible and steerable tip with a cutting end as taught in STAID. One would have been motivated to use the STAID tool because a flexible and controllable/steerable tip allows the operator to more precisely remove tissue while also reducing the likelihood of damaging the healthy tissue. There would have been a reasonable expectation of success because such tools can be used by image-guided robotic systems as taught in STAID.
Claims 27, 29, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”) and U.S. Patent Appl. Publ. No. 2021/0137612 to Staid et al. (hereinafter “STAID”) as applied to claims 24 and 26 above and further in view of U.S. Patent Appl. Publ. No. 2016/0374710 to Sinelnikov et al. (hereinafter “SINELNIKOV”).
With respect to claim 27 (depending from claim 26), neither SHELTON nor STAID explicitly teach the claim limitations.
However, SINELNIKOV teaches wherein the imager is rotatingly coupled to the robotically operated surgical tool to allow rotation of the imager around a longitudinal axis of the surgical tool.
SINELNIKOV teaches a variety of ablation catheters that include an ablation transducer for applying therapeutic ultrasound and an imaging transducer for identifying the tissue to ablate. (see, e.g., [0187] and [0310]). The catheters are configured to ablate “at least one of a carotid body, two carotid bodies, and a nerve associated therewith.” ([0006]). A variety of ablation elements can be used, for example, “ultrasound ablation transducer, RF needle, needle for injecting a chemical agent, RF electrode, laser emitter.” ([0269]).
Figure 33 and Figures 45A-45E illustrate different ablation catheters that are each delivered within a sheath and each include imaging transducers (imager) that define an exterior of the catheter. With respect to Figures 45A-45E (see, e.g., [0304]-[0310]), the catheter is delivered within a sheath 722 and is rotatably coupled to a surgical tool (see Figure 45E). The catheter 700 is rotatable in order to position an ablation transducer 726. ([0310]). The catheter includes imaging transducers 702 that form an imager of the catheter. ([0308], [0311]). The imaging transducers 702 are used to position the catheter for ablating target tissue. (Id).
Without each element being numerically referenced, the embodiment of Figure 33 also illustrates an ablation catheter having an imaging transducer 472 that is delivered within a sheath and is necessarily rotatably coupled to the surgical tool in order to position a needle for ablation.
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It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include a catheter having an imager that is rotatably coupled to the robotically controlled tool to allow rotation of the imager around a longitudinal axis of the surgical tool as taught in SINELNIKOV. One would have been motivated to add the imager to the catheter in order to identify the target tissue and/or confirm that the target tissue has been removed. There would have been a reasonable expectation of success because catheters can have both tools for removing/ablating tissue and tools for imaging the target tissue as taught by SINELNIKOV.
With respect to claim 29 (depending from claim 27), neither SHELTON nor STAID explicitly teach the claim limitations.
However, SINELNIKOV teaches a catheter that includes a cannula through which the surgical tool inserts to the tissue portion; wherein the imager is attached to an outer surface of the cannula.
As shown in Figure 33 of SINELNIKOV the catheter includes an imaging transducer 472 that forms a part of the outer surface of the catheter (i.e., the imager is attached to an outer surface of the cannula). The surgical tool includes a needle that extends through a needle lumen 473 of the catheter and is permitted to exit the catheter into a tissue portion. The needle is described in greater detail with respect to Figure 32 and a needle 465.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include a cannula through which the surgical tool inserts to the tissue portion and wherein the imager is attached to an outer surface of the cannula as taught in SINELNIKOV. One would have been motivated to add the imager of SINELNIKOV along the outer surface of the catheter in order to identify the target tissue and/or confirm that the target tissue has been removed. There would have been a reasonable expectation of success because catheters can have imagers attached to an outer surface as taught in SINELNIKOV.
With respect to claim 31 (depending from claim 27), neither SHELTON nor STAID explicitly teach the claim limitations.
However, SINELNIKOV teaches an ablation catheter comprising a cannula having a laterally positioned window, sized to allow a distal tip of the surgical tool protrude through.
As shown in Figure 33 of SINELNIKOV teaches a cannula having a laterally positioned window. The surgical tool includes a needle having a distal tip that extends through a needle lumen 473 of the catheter. The needle is described in greater detail with respect to Figure 32 and a needle 465.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include a cannula having a laterally positioned window that is sized to allow a distal tip of the surgical tool protrude through as taught in SINELNIKOV. One would have been motivated to add the laterally-positioned window of SINELNIKOV to allow passage of the ablating tools into the exterior. There would have been a reasonable expectation of success because catheters can such windows as taught in SINELNIKOV.
With respect to claim 32 (depending from claim 24), neither SHELTON nor STAID explicitly teach the claim limitations.
However, SINELNIKOV teaches a catheter in which the imager is an ultrasound imager.
As described above with respect to claims 27 and 29, SINELNIKOV teaches ultrasound imaging transducers (i.e., imager) being integrated with ablation tools. Each embodiment of Figure 33 and Figures 45A-45E include ultrasound imaging transducers (see [0293] for ultrasound imaging transducers 472 and [0310] for ultrasound imaging array 702).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include an imager in which the imager is an ultrasound imager as taught in SINELNIKOV. One would have been motivated to add the ultrasound imager to the catheter in order to identify the target tissue and/or confirm that the target tissue has been removed. There would have been a reasonable expectation of success because catheters can have both tools for removing/ablating tissue and tools for imaging the target tissue as taught in SINELNIKOV.
Claims 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”) and U.S. Patent Appl. Publ. No. 2021/0137612 to Staid et al. (hereinafter “STAID”) as applied to claim 26 above and further in view of an alternative embodiment of U.S. Patent Appl. Publ. No. 2016/0374710 to Sinelnikov et al. (hereinafter “SINELNIKOV-II”).
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With respect to claim 27 (depending from claim 26), neither SHELTON nor STAID explicitly teach the claim limitations.
However, SINELNIKOV-II teaches wherein the imager is rotatingly coupled to the robotically operated surgical tool to allow rotation of the imager around a longitudinal axis of the surgical tool. More specifically, SINELNIKOV-II teaches “[a]n embodiment shown in FIG. 38 comprises an ablation transducer 585 positioned to emit ablative ultrasound energy approximately laterally from a catheter. Distal to the ablation transducer is a rotating imaging transducer 587 that is mounted to a drive shaft 588, which may pass through the catheter shaft to a proximal end of the catheter where it is rotated by a motor.” ([0300]). Although Figure 38 shows the imaging transducers positioned distal to the ablation transducer, other embodiments may have the imager positioned proximal. ([0301]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include a catheter having an imager that is rotatably coupled to the robotically controlled tool to allow rotation of the imager around a longitudinal axis of the surgical tool as taught in SINELNIKOV-II. One would have been motivated to add the imager to the catheter in order to identify the target tissue and/or confirm that the target tissue has been removed. There would have been a reasonable expectation of success because catheters can have both tools for removing/ablating tissue and tools for imaging the target tissue as taught in SINELNIKOV-II.
With respect to claim 30 (depending from claim 27), neither SHELTON nor STAID explicitly teach the claim limitations.
However, SINELNIKOV-II teaches an ablation catheter comprising a cannula through which the surgical tool inserts to the tissue portion; wherein the imager is held within an inner lumen of the cannula.
In Figure 38 of SINELNIKOV-II, the rotating imaging transducer 587 is mounted to a drive shaft 588. ([0300]). With respect to the phrase, “a cannula through which the surgical tool inserts to the tissue portion,” Examiner is interpreting this phrase to include the surgical tool being disposed within the cannula as the cannula is inserted through the patient’s anatomy to the tissue portion.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include a catheter having a cannula through which the surgical tool inserts to the tissue portion; wherein the imager is held within an inner lumen of the cannula as taught in SINELNIKOV-II. One would have been motivated to have such a cannula in order to protect the surgical tool and the imager as the catheter is inserted through the patient’s anatomy. There would have been a reasonable expectation of success because catheters can have such cannulas as taught in SINELNIKOV-II.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”) and U.S. Patent Appl. Publ. No. 2021/0137612 to Staid et al. (hereinafter “STAID”) as applied to claim 24 above and further in view of U.S. Patent Appl. Publ. No. 2015/0057646 to Aljuri et al. (hereinafter “ALJURI”).
As discussed above with respect to claim 24, STAID teaches a robotic controller configured to implement a treatment plan (see, e.g., [0005], [0062]). STAID also teaches removing the tissue through a sequence of individual layers. “In some embodiments, the tissue 600 can be resected in a plurality of layers of substantially equal depth, in which the probe removes each subsequent layer after the tissue has been resected along the boundary for a prior layer.” (emphasis added) ([0078]; see also [0077] describing “tissue is sequentially resected with a plurality of removal layers…”). Accordingly, STAID teaches a robotic controller that is configured by the excision plan to move the surgical tool through a pattern that excises tissue throughout a first selected planar section, before moving to excise tissue in an at least second selected planar section.
However, neither SHELTON nor STAID explicitly teach wherein the imager images the tissue portion through a selectable planar section thereof.
In the same field of endeavor, ALJURI teaches using acquired ultrasound images to view the target tissue in selectable planar sections. More specifically, Figures 21A-21G show planar sections of ultrasound image data. “FIGS. 21C to 21F show a plurality of axial images 525 of a target tissue to define a three dimensional treatment plan and a user defined treatment profile in each of the plurality of images.” (emphasis added) ([0382]). “Each image 510 comprises a user input treatment profile 520. The user input treatment profile may comprise a plurality of points that are user adjustable on the image to define the treatment profile.” ([0383]). Notably, images 525A, 525B, 525C, and 525D are at different depths. (see, e.g., [0384]: “A second image 525B of the plurality of images at a second depth is shown on the display as described herein.” See also subsequent paragraphs [0385] and [0386]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON-STAID system to include an imager that images the tissue portion through a selectable planar sections thereof and a robotic controller that configures an excision plan to move the surgical tool through a pattern that excises tissue throughout a first selected planar section, before moving to excise tissue in an at least second selected planar section as taught in STAID and ALJURI. One would have been motivated to use a predetermined scan pattern that includes incremental changes in depths (as taught in STAID) and would use an imager that provided the planar selections to plan the treatment (as taught in ALJURI) to more precisely plan and remove the tissue. There would have been a reasonable expectation of success as both STAID and ALJURI teach that such systems and treatment plans can be implemented.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 A1 to Shelton et al. (hereinafter “SHELTON”) and U.S. Patent Appl. Publ. No. 2021/0137612 A1 to Staid et al. (hereinafter “STAID”) and U.S. Patent Appl. Publ. No. 2015/0057646 A1 to Aljuri et al. (hereinafter “ALJURI”) as applied to claim 33 above and further in view of International Application Publication No. WO 2019/049154 A1 (hereinafter “TECHNION”).
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With respect to claim 35, none of SHELTON, STAID, nor ALJURI teach wherein, within each selected planar section, the robotic controller is configured to move the surgical tool distally and proximally along a longitudinal axis of the tissue portion, and radially outward, while successively excising a plurality of layers of tissue.
TECHNION teaches a rigid cannula needle 3 that surrounds a flexible inner probe 4. (Figure 1 and claim 10). After the cannula needle is inserted into the tissue, the inner flexible probe exits through an end of the needle and is “advanced laterally until it reaches the outer edge of the tumor 10, at which point the detection unit will instruct the device controller that no further tumorous tissue is apparent, ablation is ceased, and the tip is withdrawn by the internal flexible probe into the external cannula. The entire device can now be rotated by an incremental angle, typically 1°, and the procedure repeated with the detection/ablation module removing tumorous tissue from another azimuthal angle at the level at which the orifice is stationed. Once this radial path has been cleared of tumorous tissue, the procedure is repeated at yet another incremental angle, until the entire circumferential slice of the tumor at the first lateral level has been removed. The device is then moved incrementally downwards, typically by 1 mm., and the entire procedure repeated at this new radial lateral level. The procedure is repeated at successive radial lateral levels until a level is reached where no tumorous tissue is found through the entire 360° rotation at that level, signifying that the flexible probe has reached the most distal and of the tumor. The tumor should then have been completely eradicated.” (emphasis added) (page 12, middle paragraph).
Claim 10 of TECHNION summarizes this procedure as “(v) continually repeating said deploying of said flexible inner probe after performing successive incremental deployment steps of said rigid outer cannula in longitudinal and rotational directions….”
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the robotic controller of the SHELTON-STAID-ALJURI system to, for each planar selection, move the surgical tool distally and proximally along a longitudinal axis of the tissue portion, and radially outward, while successively excising a plurality of layers of tissue as taught in TECHNION. One would have been motivated to use this incremental and methodical scan pattern to ensure that the tumor target tissue was completely removed. There would have been a reasonable expectation of success as TECHNION teach that such systems and treatment plans can be implemented.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”) as applied to claim 6 above and further in view of U.S. Patent Appl. Publ. No. 2021/0042878 A1 to Ghose et al. (hereinafter “GHOSE”).
With respect to claim 7 (and in light of the Section 112(b) rejection), SHELTON teaches the limitations of claims 1 and 6 as discussed above. While SHELTON does teach using intraoperative imaging, SHELTON does not teach wherein the images the second excision plan is based on indicate boundaries of the targeted tissue portion with adjacent tissue less distinctly than the pre-operative images.
GHOSE teaches that MR imaging provides higher contrast for soft tissues but is not convenient during surgery, whereas ultrasound is more convenient intraoperatively but has poorer soft tissue contrast. ([0003], [0004]). Yet “[i]n certain contexts, such imaging technologies may be used together to provide or facilitate real-time tracking of moving (i.e., dynamic) objects (e.g., moving tissues or organs), such as by using a combination of imaging technologies to allow the internal structures or features of a patient/object to be recognized and monitored.” ([0005]). As such, GHOSE teaches an automatic, real-time registration of pre-operative magnetic resonance imaging (MRI) data to intra-operative ultrasound (US) data (e.g., reconstructed images or unreconstructed data), such as to facilitate surgical guidance or other interventional procedures. (Abstract). In this case, the pre-operative images would have at least one of a higher resolution or greater contrast than the images acquired intraoperatively.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON system such that the images used to generate the second excision plan provide poorer contrast of the tissue than the pre-operative images. One would have been motivated to use MRI for pre-operative imaging and ultrasound for the interoperative imaging because, as taught in GHOSE, because while ultrasound may provide poorer contrast, it is superior to MRI for real-time imaging. There would have been a reasonable expectation of success because MRI and ultrasound images can be registered to provide surgical guidance.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2021/0196385 to Shelton et al. (hereinafter “SHELTON”) as applied to claim 1 above and further in view of U.S. Patent Appl. Publ. No. 2013/0030283 A1 to Vortman et al. (hereinafter “VORTMAN”).
With respect to claim 9¸ SHELTON does not teach the claim limitations. However, SHELTON does teach a system that includes “[d]ynamic visualization data enable the control circuit to detect position and/or volume changes of critical structures and/or relevant anatomical structure near a set resection path. If the changes in position and/or volume cause the critical structures to shift into, or within a safe margin from, the resection path, the control circuit modifies the set resection path by selecting, or at least recommending, an alternative resection path of the surgical instrument.” ([0358]).
VORTMAN teaches wherein the indication of the shifted boundary includes an indication of an excision boundary between excised and non-excised tissue, and the second working volume is defined using the excision boundary as a fiducial mark. VORTMAN teaches an image-guided therapy system. (Abstract). VORTMAN concerns movement between the treatment device and the patient. “If unplanned movement of either the transducer or the patient is detected, however, one or both of these coordinate systems become mis-registered with the other coordinate systems.” ([0006]). VORTMAN notes that some methods have been developed to address periodic motion but those are not sufficient for “non-periodic movement of the target tissue mass; for example, when the patient moves within the imaging device.” ([0009]).
VORTMAN solves this problem by tracking both the treated tissue and the non-treated tissue. VORTMAN generates a treatment plan which is to “ensure complete ablation of the target tissue mass.” ([0045]). “[T]he images are used to define a treatment boundary around the target tissue mass 16, e.g., by tracing a line on the image displayed on the display 74.” ([0047]). “After each sonication, the treated regions and untreated regions may be taken into account in generating an updated treatment plan.” ([0048]). “Once a sonication is applied, the area of the target tissue mass 16 that is destroyed (the treated region) is presented in the same fashion as the untreated region shown in FIG. 6A, and the treated region is subtracted from the untreated region in order to define the remaining untreated region within the target tissue mass 16.” ([0050]).
Notably, by subtracting the treated region from the untreated region, the indication of the shifted boundary includes an indication of a boundary between treated and untreated tissue, and the second working volume is defined using this boundary as a fiducial mark.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SHELTON system so that the shifted boundary includes an indication of a boundary between excised and non-excised tissue and the second working volume is defined using this boundary as a fiducial mark. One would have been motivated to subtract the before and after images, as taught in VORTMAN, to determine how the boundary has changed and, therefore, deicide how to change the next treatment round. There would have been a reasonable expectation of success because VORTMAN teaches that such a process can be used to determine how treatment progresses.
Conclusion
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/JASON P GROSS/Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797