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 1, 3, 5 and 11 are objected to because of the following informalities:
Claim 1 line 5, limitation "a patient" should read "the patient".
Claim 3 line 1, limitation "a CT-visible element" should read "the CT-visible element".
Claim 5 line 4, limitation "the trajectory" should read "the actual trajectory".
Claim 11 line 1 – 2, limitation "wherein the surgical trajectory includes a brain of the patient" should read "wherein the target surgical trajectory includes a brain of the patient as a surgical target", to avoid potential 101 issue of claiming living object.
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 15 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 15 recites the limitation "the ceramic stylet" in line 1. There is insufficient antecedent basis for this limitation in the claim. Limitation “ceramic stylet” is first introduced in claim 14, however, claim 15 is dependent on claim 1 not claim 14.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 – 13 and 16 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vij et al. (US 2021/0282866 A1; published on 09/16/2021) (hereinafter "Vij") in view of Truwit (US 6,267,769 B1; published on 07/31/2001).
Regarding claim 1, Vij teaches a method of adjusting a surgical trajectory pursuant to a surgical intervention ("Embodiments of the invention are directed to image-guided surgical methods … providing a trajectory guide ..." [0013]), comprising:
obtaining a target surgical trajectory into a patient ("The computer system 31 of the surgical procedure workstation 30 can be configured to provide a defined workflow(s) of actions including identifying a desired trajectory to a target surgical site …" [0148]);
grossly aligning an aiming device to the target surgical trajectory ("The computer system 31 can be configured to calculate positional adjustments of the actuators 200 a for moving the trajectory guide 200 to provide the desired trajectory." [0148]; "A rough or preliminary adjustment can be provided by an ‘Align’ action(s) in the surgical procedure workflow." [0199]) wherein the aiming device is coupled to a patient ("That is, the trajectory guide 200 can be directly attached to a skull of a patient ..." [0198]);
coupling an imaging-visible element to the aiming device ("The trajectory guide 200 can include a tower 210 defining a through-channel for releasably holding a targeting cannula Tc (FIG. 9) …" [0156]);
using intraoperative scan to obtain an image of a surgical field ("During an interventional surgical procedure … which iteratively (1) acquires MRI images at certain imaging planes in 3D space …" [0197]);
obtaining an actual trajectory of the imaging-visible element and extending forward the actual trajectory down to a surgical plan's target depth for comparison to the target surgical trajectory ("Referring to FIG. 9, from these new images, the current position and orientation of the targeting cannula Tc (FIG. 9) is identified through segmentation of images from orthogonal scan planes 1500 1, 1500 2 …" [0192]; "... compare the first intrabody trajectory to the desired intrabody trajectory that intersects a target intrabody site ..." [0020]; see Fig.9);
adjusting the actual trajectory to obtain an adjusted trajectory prior to insertion of a device via the aiming device into the patient ("… whereby slices can be aligned and a trajectory provided by the trajectory guide 200 can be re-calculated and new actuator (e.g., thumb wheel) 200 a adjustment values to move the trajectory guide to provide the desired trajectory are generated by the surgical workstation 30 and/or computer system thereof 31." [0192]).
Although Vij does not explicitly teach the targeting cannula is CT-visible, it is implied such cannula is could be visible in CT-guided procedure ("Embodiments of the present invention provide image-guided surgical systems 10 that can be configured to carry out or facilitate CT and/or MRI guided procedures ..." [0141])
In addition, in the same field of endeavor, Truwit teaches coupling a CT-visible element ("The entire positioning stem 400 or selected portions of the positioning stem may be doped so as to produce a detectable image on the display 180 of the CT scanning device 100." Col.10, Ln.25 - 41) to the aiming device ("FIG. 8 also shows a positioning stem 400. The positioning stem 400 is dimensioned so that it fits snugly within the passageway 822." Col.9, Ln.14 - 23);
using intraoperative computerized tomography (iCT) scan to obtain an image of a surgical field ("Another CT scan is then done, as depicted by step 1106, to confirm that the instrument is at the target 270. If the instrument has not reached the target 270, the needle is inserted another selected distance (step 1105)." Col.12, Ln.54 - 56; see also the loop in Fig.11).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the targeting cannula as taught by Vij with the doping material on positioning stem as taught by Truwit. Doing so would make it possible to provide a method "for accurate placement of an instrument using CT scanning equipment would be even more widely available to patients around the world than a similar MR method" (see Truwit; Col.3, Ln.22 - 55).
Regarding claim 2, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein the visible element comprises a cannula ("The trajectory guide 200 can include a tower 210 defining a through-channel for releasably holding a targeting cannula Tc (FIG. 9) …" [0156]).
In addition, Truwit teaches the modification of Vij’s targeting element to CT-visible element ("The entire positioning stem 400 or selected portions of the positioning stem may be doped so as to produce a detectable image on the display 180 of the CT scanning device 100." Col.10, Ln.25 - 41).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the targeting cannula as taught by Vij with the doping material on positioning stem as taught by Truwit. Doing so would make it possible to provide a method "for accurate placement of an instrument using CT scanning equipment would be even more widely available to patients around the world than a similar MR method" (see Truwit; Col.3, Ln.22 - 55).
Regarding claim 3, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein coupling a visible element to the aiming device comprises positioning a visible stylet into the aiming device ("The trajectory guide 200 can include a tower 210 defining a through-channel for releasably holding a targeting cannula Tc (FIG. 9) …" [0156]).
In addition, Truwit teaches the modification of Vij’s targeting element to CT-visible element ("The entire positioning stem 400 or selected portions of the positioning stem may be doped so as to produce a detectable image on the display 180 of the CT scanning device 100." Col.10, Ln.25 - 41).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the targeting cannula as taught by Vij with the doping material on positioning stem as taught by Truwit. Doing so would make it possible to provide a method "for accurate placement of an instrument using CT scanning equipment would be even more widely available to patients around the world than a similar MR method" (see Truwit; Col.3, Ln.22 - 55).
Regarding claim 4, Vij in view of Truwit teaches all claim limitations, as applied in claim 3, and Vij further teaches wherein the visible stylet is inserted into the aiming device without inserting the stylet into the patient ("The trajectory guide 200 can include a tower 210 defining a through-channel for releasably holding a targeting cannula Tc (FIG. 9) …" [0156]; see Fig.9).
In addition, Truwit teaches the modification of Vij’s targeting element to CT-visible element ("The entire positioning stem 400 or selected portions of the positioning stem may be doped so as to produce a detectable image on the display 180 of the CT scanning device 100." Col.10, Ln.25 - 41).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the targeting cannula as taught by Vij with the doping material on positioning stem as taught by Truwit. Doing so would make it possible to provide a method "for accurate placement of an instrument using CT scanning equipment would be even more widely available to patients around the world than a similar MR method" (see Truwit; Col.3, Ln.22 - 55).
Regarding claim 5, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein adjusting the actual trajectory comprises:
rotating the image to match an XY orientation of how the aiming device was mounted on the patient's head ("… through segmentation of images from orthogonal scan planes 1500 1, 1500 2, whereby slices can be aligned and a trajectory provided by the trajectory guide 200 can be re-calculated …" [0192]); and
using adjustment dials on an XY stage to refine the trajectory closer to target surgical trajectory ("… and new actuator (e.g., thumb wheel) 200 a adjustment values to move the trajectory guide to provide the desired trajectory are generated by the surgical workstation 30 and/or computer system thereof 31." [0192]; "After segmenting the cannula, the surgical procedure computer system 31 (e.g., software algorithms, circuits or modules) can then calculate one or more actuator 200 a adjustment, e.g., the thumbwheel or knob 200 k turn adjustment needed for one or more of the pitch, roll, X or Y actuators 205-208 to align the trajectory guide 200 to the desired trajectory." [0199]; see Fig.2).
Regarding claim 6, Vij in view of Truwit teaches all claim limitations, as applied in claim 5, and Vij further teaches wherein the adjustment dials include an X adjustment dial and a Y adjustment dial ("… a Y direction actuator 207 and an X direction actuator 208. Where used, the X and Y- direction actuators 207, 208 can both be coupled to an X-Y table 202." [0156]; see Fig.2).
Regarding claim 7, Vij in view of Truwit teaches all claim limitations, as applied in claim 5, and Vij further teaches wherein the adjustment dials are manually rotated by a user to obtain an X adjustment and a Y adjustment ("Our current Thumb Wheel Extension, which also uses a drive cable to manually operate the thumb wheels at a distance, has an exposed length of about 8 mm." [0231]).
Regarding claim 8, Vij in view of Truwit teaches all claim limitations, as applied in claim 5, and Vij further teaches wherein the adjustment dials are coupled to a motor ("The X-direction stepper motor 313 can be coupled to the X-direction actuator 208. The Y-direction stepper motor 314 can be coupled to the Y-direction actuator 207." [0172]).
Regarding claim 9, Vij in view of Truwit teaches all claim limitations, as applied in claim 8, and Vij further teaches wherein the motor automatically rotates the adjustment dials ("… automatically drives the thumbwheels using remote control inputs and motors coupled to the torque transfer shafts 220 to make required adjustments." [0197]).
Regarding claim 10, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein the actual trajectory is defined by a forward extension of a long axis of a stylet inserted into the aiming device (see Fig.9).
Regarding claim 11, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein the surgical trajectory includes a brain of the patient ("… including deep brain sites for neurosurgeries …" [0141]; see Fig.9).
Regarding claim 12, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches inserting a stylet into the brain along the adjusted trajectory ("… for guiding the alignment of the targeting cannula Tc held by the trajectory guide 200 to a planned trajectory, monitoring the insertion of a delivery cannula, and adjusting the (X-Y) position in cases where the placement needs to be corrected." [0205]).
Regarding claim 13, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein the adjusted trajectory reduces or eliminates a deviation in trajectory relative to an original surgical plan ("… automatically drives the thumbwheels using remote control inputs and motors coupled to the torque transfer shafts 220 to make required adjustments. This entire process is repeated until the user is satisfied with the projected error indicated by the software or based on a default or selected threshold or maximal acceptable error." [0197]).
Regarding claim 16, Vij in view of Truwit teaches all claim limitations, as applied in claim 3, and Vij further teaches wherein the stylet is initially positioned with a distal tip of the stylet adjacent dura matter of a brain (see Fig.9).
Regarding claim 17, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein the surgical intervention relates to a deep brain stimulation electrode lead placement procedure ("… place interventional devices to any desired internal region of the body or object, including deep brain sites for neurosurgeries ..." [0141]; "… an interventional device such as … a stimulation lead and the like." [0156]).
Regarding claim 18, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches automatically calculating a deviation between the target surgical trajectory and the actual trajectory ("… automatically drives the thumbwheels using remote control inputs and motors coupled to the torque transfer shafts 220 to make required adjustments. This entire process is repeated until the user is satisfied with the projected error indicated by the software or based on a default or selected threshold or maximal acceptable error." [0197]).
Regarding claim 19, Vij in view of Truwit teaches all claim limitations, as applied in claim 18, and Vij further teaches providing directional dial-turn instructions for an XY stage ("… and new actuator (e.g., thumb wheel) 200 a adjustment values to move the trajectory guide to provide the desired trajectory are generated by the surgical workstation 30 and/or computer system thereof 31." [0192]; "After segmenting the cannula, the surgical procedure computer system 31 (e.g., software algorithms, circuits or modules) can then calculate one or more actuator 200 a adjustment, e.g., the thumbwheel or knob 200 k turn adjustment needed for one or more of the pitch, roll, X or Y actuators 205-208 to align the trajectory guide 200 to the desired trajectory." [0199]; see Fig.2).
Claim 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vij in view of Truwit, as applied in claim 1, and further in view of Eklund (US 2008/0200798 A1; published on 08/21/2008) (hereinafter "Eklund").
Regarding claim 14, Vij in view of Truwit teaches all claim limitations, as applied in claim 3, except wherein the stylet is a ceramic stylet.
However, in the same field of endeavor, Eklund teaches wherein the stylet is a ceramic stylet ("With the above in mind, the trajectory guide may comprise components made of any materials known in the state of the art. Non-limiting examples of material which can be used in computed tomography and magnetic resonance imaging are carbon fiber, glass fiber, plastics or ceramics." [0039]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the targeting cannula as taught by Vij with the ceramic material for trajectory guide as taught by Eklund. Since ceramic is a material dense enough to be radiopaque, it is a good material "be visible in such a way that the markers are easily distinguishable in the produced image" (see Eklund; [0039]).
Regarding claim 15, Vij in view of Truwit teaches all claim limitations, as applied in claim 1, and Vij further teaches wherein the stylet has a hollow lumen ("The trajectory guide 200 can include a tower 210 defining a through-channel for releasably holding a targeting cannula Tc (FIG. 9) …" [0156]).
In addition, in the same field of endeavor, Eklund teaches wherein the stylet is a ceramic stylet ("With the above in mind, the trajectory guide may comprise components made of any materials known in the state of the art. Non-limiting examples of material which can be used in computed tomography and magnetic resonance imaging are carbon fiber, glass fiber, plastics or ceramics." [0039]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the targeting cannula as taught by Vij with the ceramic material for trajectory guide as taught by Eklund. Since ceramic is a material dense enough to be radiopaque, it is a good material "be visible in such a way that the markers are easily distinguishable in the produced image" (see Eklund; [0039]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797