DETAILED ACTION
Summary
Claims 1-8, 10-24 are pending in the application. Claims 22-24 are withdrawn from further consideration. Claims 1-8, 10-21 are rejected under 35 USC 103.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 3, 7, 13-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (U.S PGPub 2020/0289224 A1) in view of Stanton et al. (U.S PGPub 2018/0014890 A1) and Wilson (U.S Patent 9,386,974 B2).
Regarding Claim 1, Johnson teaches a brain surgery system having a robotic arm for guiding insertion of a retractor into a subject brain (Abstract) (the “brain surgery system” and “for insertion of a retractor into a subject brain” are considered statements of intended use, and the system of Johnson is capable of being used for brain surgery), the system comprising:
an imaging system (Fig. 12B, 1306) comprising a radiation source and a detector adapted to measure radiation emitted by the radiation source [0093], the detector being further adapted to output imaging data based on the measured radiation [0093];
a computer (Fig. 5, 408) system having at least one processor and memory [0065] (a computer necessarily contains at least one processor and memory);
a robotic arm (Fig. 1, 104) [0049] controlled by software executing on said at least one processor [0065]; and
an end effector (Fig. 20, 1600) attached to the robotic arm [0142]-[0143] and adapted to hold a retractor (Fig. 20, 608) [0076]+[0142], the end effector comprising:
a linear slide (Fig. 20, 1604) having a fixed portion (Fig. 20, 1606) adapted to attach to the robotic arm (Fig. 20, 1606 attaches to arm through 1600) and a movable portion (Fig. 20, 1608) [0144], the linear slide being adapted to move the retractor in a longitudinal direction of the retractor (Fig. 20+21, the moving portion 1608 moves in a longitudinal direction of the instrument) to insert the retractor into the subject brain [0145] (inserting the retractor into the brain is considered a statement of intended use, the linear slide is capable of being used to insert retractor 608 into a patient’s brain); and
a stand (Fig. 20, 1610) affixed to the linear slide (Fig. 20, 1608) and adapted to hold the retractor (Fig. 20, 608) [0145].
Johnson fails to explicitly teach the robotic arm is mounted on the imaging system. Johnson further fails to explicitly teach wherein the retractor comprises a vial with a trocar positioned within an interior of the vial, the retractor being adapted to be inserted into a subject brain, wherein the retractor is adapted to allow removal of the trocar from the retractor while leaving the vial in place in the subject brain.
Stanton teaches a retractor system (Abstract). This system uses a robotic arm (Fig. 3, 301) mounted to an imaging device (Fig. 3, 303) to use the medical instrument [0038]. Stanton further teaches wherein the retractor comprises a vial (Fig. 5B, 505) with a trocar (Fig. 5B, 509) positioned within an interior of the vial [0054]-[0056] (dilator is a vial, and the awl or similar device is a trocar), wherein the retractor is adapted to allow removal of the trocar from the retractor while leaving the vial in place in the subject brain [0062].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of mounting the robotic arm of Johnson to mount it on an imaging device, as taught by Stanton, as the substitution for one known method of mounting a robotic arm with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of mounting the robotic arm to an imaging device are reasonably predictable. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the tool so is a vial and trocar, as taught by Stanton, because this tool improves the safety and speed of minimally invasive procedures, as recognized by Stanton [0002].
The combination fails to teach the tool is a retractor adapted to be inserted into a subject brain.
Wilson teaches a system performing brain surgery (Abstract). This system uses a vial (Fig. 1, 12) and trocar (Fig. 1, 14) (Col 7, lines 14-20) as a retractor system for brain surgery (Col 7, lines 42-53).
It would have been obvious to one of ordinary skill in the art to use the retractor on a patient’s brain, as taught by Wilson, because this allows the user to operate further inside the brain than otherwise possible, thereby being able to treat more patients, as recognized by Wilson (Col 5-6, lines 62-12).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the linear slide comprises a sensor to measure movement of the movable portion relative to the fixed portion [0147].
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the stand (Fig. 20, 1610) is at a distal end of the movable portion of the linear slide (Fig. 20, 1608) and extends in a direction substantially perpendicular to a longitudinal direction of the movable portion of the linear slide (Fig. 20, 1610 extends in a direction perpendicular to a longitudinal direction of 1608) [0145].
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Johnson further teaches a controller (Fig. 5, 538) [0058] and being configured to control the robotic arm based on communication with the software executing on said at least one processor [0065]+[0067] (the controller controls the robotic arm, which in turn is controlled by the software running on a computer).
Johnson is silent regarding the controller containing a processor.
Stanton further teaches a controller can be a processor [0074].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the controller of Johnson with a processor, as taught by Stanton, as the substitution for one known controller with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a processor as a controller are reasonably predictable.
Regarding Claim 14, Johnson teaches an end effector (Fig. 20, 1600) adapted to attach to a robotic arm [0142]-[0143] and adapted to hold a retractor (Fig. 20, 608) [0076]+[0142] including a vial with a trocar positioned within an interior of the vial, the retractor being adapted to be inserted into a subject brain, the end effector comprising:
a linear slide (Fig. 20, 1604) having a fixed portion (Fig. 20, 1606) adapted to attach to the robotic arm (Fig. 20, 1606 attaches to arm through 1600) and a movable portion (Fig. 20, 1608) [0144], the linear slide being adapted to move the retractor in a longitudinal direction of the retractor (Fig. 20+21, the moving portion 1608 moves in a longitudinal direction of the instrument) to insert the retractor into the subject brain [0145] (inserting the retractor into the brain is considered a statement of intended use, the linear slide is capable of being used to insert retractor 608 into a patient’s brain); and
a stand (Fig. 20, 1610) affixed to the linear slide (Fig. 20, 1608) and adapted to hold the retractor (Fig. 20, 608) [0145].
Johnson fails to explicitly teach a retractor including a vial with a trocar positioned within an interior of the vial, the retractor being adapted to be inserted into a subject brain.
Stanton further teaches wherein the retractor comprises a vial (Fig. 5B, 505) with a trocar (Fig. 5B, 509) positioned within an interior of the vial [0054]-[0056] (dilator is a vial, and the awl or similar device is a trocar), wherein the retractor is adapted to allow removal of the trocar from the retractor while leaving the vial in place in the subject brain [0062].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the tool so is a vial and trocar, as taught by Stanton, because this tool improves the safety and speed of minimally invasive procedures, as recognized by Stanton [0002].
The combination fails to teach the tool is a retractor adapted to be inserted into a subject brain.
Wilson teaches a system performing brain surgery (Abstract). This system uses a vial (Fig. 1, 12) and trocar (Fig. 1, 14) (Col 7, lines 14-20) as a retractor system for brain surgery (Col 7, lines 42-53).
It would have been obvious to one of ordinary skill in the art to use the retractor on a patient’s brain, as taught by Wilson, because this allows the user to operate further inside the brain than otherwise possible, thereby being able to treat more patients, as recognized by Wilson (Col 5-6, lines 62-12).
Regarding Claim 15, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the linear slide comprises a sensor to measure movement of the movable portion relative to the fixed portion [0147].
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the stand (Fig. 20, 1610) is at a distal end of the movable portion of the linear slide (Fig. 20, 1608) and extends in a direction substantially perpendicular to a longitudinal direction of the movable portion of the linear slide (Fig. 20, 1610 extends in a direction perpendicular to a longitudinal direction of 1608) [0145].
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 1 above, and further in view of Cavanagh (U.S PGPub 2015/0100067 A1).
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the computer system is adapted to receive the imaging data [0088] and to control the robotic arm to move the end effector to the insertion position and insertion orientation [0123]+[0127] (A desired trajectory would be point and insertion position and orientation).
Johnson fails to explicitly teach the computer system is adapted to determine an insertion position and an insertion orientation.
Cavanagh teaches a method for surgical insertion (Abstract). This system has a computer (Fig. 1, 111) [0019] which determine an optimal entry point and orientation based on acquired image data [0019].
It would ha been obvious to one of ordinary skill in the art before the effective filing date to have the computer determine the entry point and trajectory, as taught by Cavanagh, because this improves the accuracy of placing the medical device, as recognized by Cavanagh [0003].
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 1 above, and further in view of Garcia Kilroy et al. (U.S PGPub 2018/0116741 A1).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach wherein the end effector comprises a knob turnable to move the movable portion relative to the fixed portion.
Garcia Kilroy teaches a robotic surgical assembly (Abstract). This system uses a turnable object to move the movable portion relative to the fixed portion [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of moving the movable portion to using a turnable object, as taught by Garcia, as the substitution for one known method of actuating the movable portion with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of turning the object to create linear motion are reasonably predictable.
The combination fails to explicitly teach a knob.
Stanton teaches the actuator for retracting or extending the guide can be a knob (Claims 14-15).
It would have been obvious to one of ordinary skill in the art to modify the combined system to include a knob for motion, as taught by Stanton, because this allow the user to manually move the movable portion to the fixed position, thereby increasing the ease of using the linear slide.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 1 above, and further in view of Garcia Kilroy et al. and Grover et al. (U.S PGPub 2017/0273749 A1)
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the fixed portion of the linear slide comprises at least one rail [0144], and the movable portion of the linear slide comprises a bar in communication with said at least one rail and adapted to move along said at least one rail [0145].
Johnson fails to explicitly teach wherein the bar is a substantially flat plate positioned between said at least one rail and a second rail.
Garcia Kilroy teaches a tool holder for robotic surgery (Abstract). This system has a linear guide (Fig. 3A, 310) with a moving portion which is a plate (Fig. 3A, 322) positioned between at least one rail and a second rail (Fig. 3A, 316) [0070]-[0071].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the moving portion be between at least one rail and a second rail, as taught by Garcia Kilroy, as the substitution for one known linear slide member with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a bar and two rails as the linear guide are reasonably predictable.
The combination is silent on the bar being a substantially flat plate.
Grover teaches a robotically controlled surgical system (Abstract). This system has a substantially flat plate as a mounting bracket (Fig. 5, 150) [0054].
It would have been obvious to one of ordinary skill in the art to substitute the mounting carriage of the combination to be a substantially flat plate, as taught by Grover, as the substitution for one known mounting carriage with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a substantially flat plated mounting carriage are reasonably predictable.
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach wherein the bar comprises two guides affixed to an underside thereof, the guides extending in a longitudinal direction of the bar and being positioned to engage with said at least one rail and the second rail, respectively.
Garcia Kilroy further teaches wherein the bar comprises two guides affixed to an underside thereof (Fig. 3B, 322 has guides on underside) [0071]-[0072], the guides extending in a longitudinal direction of the bar (See annotated figure below) and being positioned to engage with said at least one rail and the second rail, respectively [0071]-[0072].
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It would have been obvious to one of ordinary skill in the art to substitute the mounting carriage of the combination to be a substantially flat plate, as taught by Grover, as the substitution for one known mounting carriage with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a substantially flat plated mounting carriage are reasonably predictable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 1 above, and further in view of Huang et al. (U.S PGPub 2024/0009840 A1).
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the stand comprises an elongate portion (Fig. 20, 1610 is elongate, and has an elongate portion) and a clamp portion adapted to hold the retractor in place [0145], wherein the stand further comprises a base portion affixed to the linear slide (Fig. 20, 1610 the portion affixed to 1608 is the base portion).
Johnson fails to explicitly teach a receptacle to receive and lock in place the elongate portion of the stand.
Huang teaches a surgical robot system (Abstract). This system uses an end flange to connect the support to the linear slide block [0071].
It would have been obvious to one of ordinary skill in the art to modify the combined system so the support member locks in place to the linear member, as taught by Huang, because this allows the user to better choose the retractor and the stand based on the needs of the patient, thereby increasing the quality of surgery, as taught by Huang [0051]. One of ordinary skill would recognize the end flange of Huang would be connected into a receptacle, as taught by Johnson (Fig. 9B, 604 and 1206 shows an end flange connecting to a robotic arm, and the flange is described as connecting with depressions (i.e. receptables) for connection [0077].
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 1 above, and further in view of Wilson (U.S Patent 9,386,974 B2).
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach wherein the trocar comprises, at a proximal end, a base portion adapted to be in communication with a corresponding base portion of the vial, wherein the base portion of the trocar and the base portion of the vial cooperate to prevent separation of the trocar and the vial as the retractor is inserted into and/or retracted from the subject brain.
Stanton further teaches wherein the trocar comprises, at a proximal end, a base portion (Fig. 5B, 515) and a corresponding base portion of the vial (Fig. 5B, 506).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the tool so is a vial and trocar, as taught by Stanton, because this tool improves the safety and speed of minimally invasive procedures, as recognized by Stanton [0002].
Stanton is silent regarding the base portions in communication adapted to be in communication with each other, or wherein the base portion of the trocar and the base portion of the vial cooperate to prevent separation of the trocar and the vial as the retractor is inserted into and/or retracted from the subject brain.
Wilson further teaches the base portions in communication with each other (Fig. 7-8, the handle 26 of trocar interacts with proximal portion of 12) (Col 7, lines 49-53)+(Col 9, lines 25-28), or wherein the base portion of the trocar and the base portion of the vial cooperate to prevent separation of the trocar and the vial as the retractor is inserted into the subject brain (Fig. 7-8, the handle 26 of trocar interacts with proximal portion of 12) (Col 7, lines 49-53)+(Col 9, lines 25-28) (as the handle 26 is wider than the cannula, as the trocar is push in the base portion would push into cannular, which prevents separation of the trocar and the cannula (vial)).
It would have been obvious to one of ordinary skill in the art to use the retractor on a patient’s brain, as taught by Wilson, because this allows the user to operate further inside the brain than otherwise possible, thereby being able to treat more patients, as recognized by Wilson (Col 5-6, lines 62-12).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 1 above, and further in view of Stoianovici et al. (U.S Patent 7,822,466 B2) and Wilson.
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the computer system is adapted to execute software on said at least one processor [0065].
Johnson fails to explicitly teach displaying the imaging data on a display to provide one or more images; receiving a user input specifying a target location within a selected one of said one or more images of the subject brain; and receiving a user input specifying an insertion point of the retractor.
Stoianovici teaches a system for minimally invasive surgery (Abstract). This system displaying the imaging data on a display to provide one or more images (Col 12, lines 40-52), receiving a user input specifying a target location within a selected one of said one or more images of the subject brain (Col 12, lines 40-52); and receiving a user input specifying an insertion point of the retractor (Col 12, lines 40-52) (entry point).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to receive user input specifying the entry and target position, as taught by Stoianovici, because this reduces the radiation exposure of the physician, thereby increasing the safety of the procedure, as recognized by Stoianovici (Col 16, lines 26-33). One of ordinary skill would recognize that, in the combination, the insertion point would be of the retractor of Stanton.
The combination is silent regarding the system including images of the subject’s brain.
Wilson teaches a system performing brain surgery (Abstract). This system uses a vial (Fig. 1, 12) and trocar (Fig. 1, 14) (Col 7, lines 14-20) as a retractor system for brain surgery (Col 7, lines 42-53).
It would have been obvious to one of ordinary skill in the art to use the retractor on a patient’s brain, as taught by Wilson, because this allows the user to operate further inside the brain than otherwise possible, thereby being able to treat more patients, as recognized by Wilson (Col 5-6, lines 62-12). One of ordinary skill would recognize that, in the combination, the image’s would be of the subject’s brain as the procedure of Wilson is being performed on the brain.
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the computer system is further adapted to execute software on said at least one processor [0065], the end effector (Fig. 20, 1600) being attached to the robotic arm [0142]-[0143] and holding the retractor (Fig. 20, 608) [0076]+[0142].
Johnson fails to explicitly teach determining an insertion position and an insertion orientation based at least in part on the specified insertion point and the specified target location; and controlling the robotic arm to move an end effector to the insertion position and the insertion orientation, the end effector being attached to the robotic arm and holding the retractor.
Stoianovici further teaches determining an insertion position and an insertion orientation based at least in part on the specified insertion point and the specified target location (Col 12, lines 40-52) (the driver registration determines the insertion position and orientation from the selected position and orientation); and controlling the robotic arm to move an end effector to the insertion position and the insertion orientation (Col 12, lines 53-58)(Col 11, lines 18-22) (the system is computer controller).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to receive user input specifying the entry and target position, as taught by Stoianovici, because this reduces the radiation exposure of the physician, thereby increasing the safety of the procedure, as recognized by Stoianovici (Col 16, lines 26-33).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 14 above, and further in view of Garcia Kilroy et al.
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach wherein the end effector comprises a knob turnable to move the movable portion relative to the fixed portion.
Garcia Kilroy teaches a robotic surgical assembly (Abstract). This system uses a turnable object to move the movable portion relative to the fixed portion [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of moving the movable portion to using a turnable object, as taught by Garcia, as the substitution for one known method of actuating the movable portion with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of turning the object to create linear motion are reasonably predictable.
The combination fails to explicitly teach a knob.
Stanton teaches the actuator for retracting or extending the guide can be a knob (Claims 14-15).
It would have been obvious to one of ordinary skill in the art to modify the combined system to include a knob for motion, as taught by Stanton, because this allow the user to manually move the movable portion to the fixed position, thereby increasing the ease of using the linear slide.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 14 above, and further in view of Garcia Kilroy et al. and Grover et al.
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the fixed portion of the linear slide comprises at least one rail [0144], and the movable portion of the linear slide comprises a bar in communication with said at least one rail and adapted to move along said at least one rail [0145].
Johnson fails to explicitly teach wherein the bar is a substantially flat plate positioned between said at least one rail and a second rail.
Garcia Kilroy teaches a tool holder for robotic surgery (Abstract). This system has a linear guide (Fig. 3A, 310) with a moving portion which is a plate (Fig. 3A, 322) positioned between at least one rail and a second rail (Fig. 3A, 316) [0070]-[0071].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the moving portion be between at least one rail and a second rail, as taught by Garcia Kilroy, as the substitution for one known linear slide member with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a bar and two rails as the linear guide are reasonably predictable.
The combination is silent on the bar being a substantially flat plate.
Grover teaches a robotically controlled surgical system (Abstract). This system has a substantially flat plate as a mounting bracket (Fig. 5, 150) [0054].
It would have been obvious to one of ordinary skill in the art to substitute the mounting carriage of the combination to be a substantially flat plate, as taught by Grover, as the substitution for one known mounting carriage with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a substantially flat plated mounting carriage are reasonably predictable.
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach wherein the bar comprises two guides affixed to an underside thereof, the guides extending in a longitudinal direction of the bar and being positioned to engage with said at least one rail and the second rail, respectively.
Garcia Kilroy further teaches wherein the bar comprises two guides affixed to an underside thereof (Fig. 3B, 322 has guides on underside) [0071]-[0072], the guides extending in a longitudinal direction of the bar (See annotated figure below) and being positioned to engage with said at least one rail and the second rail, respectively [0071]-[0072].
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It would have been obvious to one of ordinary skill in the art to substitute the mounting carriage of the combination to be a substantially flat plate, as taught by Grover, as the substitution for one known mounting carriage with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a substantially flat plated mounting carriage are reasonably predictable.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton and Wilson as applied to claim 14 above, and further in view of Parrini et al. (U.S PGPub 2021/0275263 A1).
Regarding Claim 20, the combination teaches the invention substantially as claimed. Johnson further teaches wherein the stand comprises an elongate portion (Fig. 20, 1610 is elongate, and has an elongate portion) and a clamp portion adapted to hold the retractor in place [0145].
Johnson fails to explicitly teach wherein the clamp portion comprises two opposing portions that together form a portion of a circle.
Parrini teaches a surgical guide system (Abstract). This system uses an O-ring claim (which has two opposing portions which together form a circle) [0110].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the clamp of the combined system so it forms a portion of a circle, as taught by Parrini, as the substitution for one known clamp with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a clamp which forms a portion of a circle are reasonably predictable.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Stanton, Wilson, and Parrini as applied to claim 20 above, and further in view of Huang et al.
Regarding Claim 21, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the stand further comprises a base portion affixed to the linear slide (Fig. 20, 1610 the portion affixed to 1608 is the base portion).
Johnson fails to explicitly teach a receptacle to receive and lock in place the elongate portion of the stand.
Huang teaches a surgical robot system (Abstract). This system uses an end flange to connect the support to the linear slide block [0071].. The flange is attached using a bolt (i.e. receptable) [0051].
It would have been obvious to one of ordinary skill in the art to modify the combined system so the support member locks in place to the linear member, as taught by Huang, because this allows the user to better choose the retractor and the stand based on the needs of the patient, thereby increasing the quality of surgery, as taught by Huang [0051]. One of ordinary skill would recognize the end flange of Huang would be connected into a receptacle, as taught by Johnson (Fig. 9B, 604 and 1206 shows an end flange connecting to a robotic arm, and the flange is described as connecting with depressions (i.e. receptables) for connection [0077].
Response to Arguments
Applicant's arguments filed 1/16/2026 have been fully considered but they are not persuasive.
Applicant argues that the combination of Johnson, Stanton, and Wilson does not result in the combined invention.
Applicant argues that the Wilson’s disclosure is incompatible with the system of Johnson and Stanton, as the system of Wilson requires manual insertion of dilating obturator, and therefore Wilson teaches away from the combined system. The Examiner disagrees. Nowhere in the Wilson reference is it stated that the obturator must be inserted manually, and the Wilson reference does not state that the obturator is incapable of being inserted robotically. Wilson does not teach away from the robotic insertion because the “disclosure does not criticize, discredit, or otherwise discourage the solution claimed” (MPEP 2141.02(VI)). The Applicant further argues that the robotic arm of Johnson is not capable of “gently” inserting the obturator. The Examiner disagrees. The Johnson reference explicitly teaches that the system can be used with a retractor [0095]. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007) (MPEP 2141.03). It is well within the capabilities of one of ordinary skill to program a robotic arm to insert a medical object with reduced force (i.e. gently).
Applicant continues to argue that the Wilson reference requires direct visualization during the insertion step, which is incompatible with the Johnson reference. The Examiner disagrees. The insertion of the medical tools of Johnson are performed under image guidance (See at least Fig. 11, 1514, [0066], [0083], [0092]). One of ordinary skill would understand how to track the medical devices in the combined system.
Applicant argues that the tools of Stanton are not capable of being used in the brain. The Examiner disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Wilson is used to teach using the vial and trocar in the brain. Furthermore, "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007) (MPEP 2141.03). One of ordinary skill, wanting to perform surgery in the brain, would understand the types of tool needed to safely perform surgery in the brain.
Applicant argues that the teachings of Wilson teaches away from the combination. The Examiner disagrees. Nothing in Wilson “disclosure does not criticize, discredit, or otherwise discourage the solution claimed” (MPEP 2141.02(VI)). The claim is therefore suggested by the combination of references, and the rejection under 35 USC 103 is maintained. For similar reasons, the rejections of the other claims are also maintained.
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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/SEAN D MATTSON/Primary Examiner, Art Unit 3798