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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12, 207, 892. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim discloses all of the claimed limitations as follow:
a patient support, an imaging device including an imaging gantry with one or more imaging components configured for linear movement along a longitudinal axis of the patient support to obtain imaging data of the patient, a motion tracking apparatus configured to track at least one of the patient and the imaging device, and a robotic arm having a first end supporting an end effector and configured to extend into an imaging area of imaging gantry, and a second end operatively attached to the patient support, the method comprising:
moving the imaging gantry along the longitudinal axis of the patient support;
tracking the imaging gantry and the patient;
controlling the robotic arm to avoid collision with the patient and the imaging gantry as at least one of the imaging device and patient is moved as detected by the motion tracking apparatus [see column 20 lines 15-33].
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12, 207, 892. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim discloses all of the claimed limitations as follow:
a patient support for supporting a patient above a ground surface;
an imaging device including a support structure supporting an imaging gantry for linear movement along a longitudinal axis of the patient support, the imaging gantry supporting an x- ray source and an x-ray detector arranged for movement relative to the gantry to obtain imaging data of the patient;
a motion tracking apparatus configured to track at least one of the patient and the imaging device; and
a robotic arm having a first end supporting an end effector and configured to extend into an imaging area of imaging gantry, and a second end operatively attached to the patient support, the robotic arm being configured to avoid collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus [see column 20 lines 15-33].
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12, 207, 892. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim discloses all of the claimed limitations as follow:
a patient support coupled to a column for supporting a patient above a ground surface; an imaging device including a support structure supporting an imaging gantry for linear movement along an axis of a bore of the imaging gantry, the imaging gantry supporting one or more imaging components arranged for movement relative to the support structure to obtain imaging data of the patient;
a motion tracking apparatus configured to track at least one of the patient and the imaging device; and
a robotic arm having an end effector and configured to extend into an imaging area of imaging gantry, the robotic arm being configured to avoid collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus [see column 20 lines 15-33].
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.
Claim(s) 1-5, 8-10, 12-14, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kuduvalli et al (Pub. No.: US 2012/0035470) in view of Heuscher (Pub. No.: US 2010/0274120) and further in view of Stefanchik et al (Pub. No.: US 2013/0085510).
Regarding claim 1, Kuduvalli et al disclose a method for performing robotically-assisted surgery
including a system, comprising
a patient support (treatment couch TC) [see 0037 and figs 5-7, 9,12, 17A, 18A-18D];
an imaging device including an imaging gantry [see 0012] with one or more imaging components (kV imaging source and kV imaging detector) configured for linear movement along a longitudinal axis of the patient support to obtain imaging data of the patient [see 0038, 0040, 0045, 0056] by disclosing each of the kV imaging source and kV imaging detector may be slidably coupled toa single continuous beam member that extends outwardly at a fixed orientation [see 0040];
a motion tracking apparatus configured to track at least one of the patient and the imaging device [see 0034] by disclosing a non-x-ray based position sensing system 134 senses position and/or movement of external marker(s) strategically affixed to the patient, and/or senses position and/or movement of the patient skin surface itself [see 0034];
a robotic arm having a first end supporting an end effector and configured to extend into an imaging area of imaging gantry [see figs 2A-4, 11-12];
tracking the imaging gantry and the patient [see 0034];
Kuduvalli et al don’t disclose moving the imaging gantry along the longitudinal axis of the patient support.
Nonetheless, Heuscher discloses moving the imaging gantry along the longitudinal axis of the patient support [see 0023 and fig 1] by disclosing support 126 is stationary while the rotating gantry 104 is axially movable along tracks 128 that run parallel to the axis 120, which enables an operator of the system to suitably define the VOI to encompass the whole subject or a portion thereof for scanning [see 0023]
Kuduvalli et al and Heuser don’t disclose controlling the robotic arm to avoid collision with the patient and the imaging gantry as at least one of the imaging device and patient is moved as detected by the motion tracking apparatus.
Nonetheless, Stefanchik et al disclose the robotic arm being configured to avoid (by having the awareness of the position and orientation of end effector, etc., emphasis added) collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus [see 0033-0035, 0040-0043] by disclosing the controller can have an awareness of the position and orientation of the platform 118 relative to the support frame 108 or other components of the robot 104 (e.g., the surgical arms 110 to which the various end effectors 116 are coupled) and when the position or orientation of the platform 118 is adjusted and the controller 106 can automatically make corresponding adjustments to the position or orientation of one or more of the end effectors 116 [see 0034].
a second end operatively attached to the patient support [see figs 3, 5].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by moving the imaging gantry along the longitudinal axis of the patient support; to enable an operator of the system to suitably define the VOI to encompass the whole subject or a portion thereof for scanning [see 0023, Heuser] and by controlling the robotic arm to avoid collision with the patient and the imaging gantry as at least one of the imaging device and patient is moved as detected by the motion tracking apparatus; so that the controller 106 can automatically make corresponding adjustments to the position or orientation of one or more of the end effectors 116 [see 0034 Stefanchik et al].
Regarding claim 2, Kuduvalli et al and Heuser don’t disclose maintain a pre-determined position and orientation of the end effector while the imaging device obtains the imaging data of the patient.
Nonetheless, Stefanchik et al disclose maintain a pre-determined position and orientation of the end effector while the imaging device obtains the imaging data of the patient [see 0034] by disclosing controller 106 can thus be configured to maintain a fixed frame of reference between the platform 118 and one or more of the end effectors 116 [see 0032-0034, 0040, abstract].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by maintaining a pre-determined position and orientation of the end effector while the imaging device obtains the imaging data of the patient; for eliminating the need for recalibration of the system due to patient movement [see abstract, Stefanchik et al].
Regarding claim 3, Kuduvalli et al and Heuser don’t disclose wherein the motion tracking apparatus is further configured to track the robotic arm.
Nonetheless, Stefanchik et al disclose motion tracking apparatus is further configured to track the robotic arm [see 0033] by disclosing robot 104 can also include a sensor system 120 configured to provide closed loop feedback as to the position and orientation of the surgical platform 118 and/or of the various end effectors 116 and the sensor data can also be used to create a 3D rendering of the respective positions and orientations of the surgical arms 110, end effectors 116, platform 118, etc., which can be displayed to a user via the user interface 102 [see 0033].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by tracking the robotic arm; to confirm its understanding of the position and orientation of such components [see 0033, Stefanchik et al].
Regarding claims 4-5, Kuduvalli et al and Heuser don’t disclose tracking the end effector of the robotic arm and detect movement of the end effector from the pre-determined position and orientation with respect to the patient.
Nonetheless, Stefanchik et al disclose tracking the end effector of the robotic arm and detect movement of the end effector from the pre-determined position and orientation (fixed frame of reference) with respect to the patient [see 0033-0035, 0040] by disclosing it will thus be appreciated that movement of the platform 118, whether inadvertent or intentional, can be detected by the controller 106 and compensated for, without the need for the cumbersome and complicated recalibration procedures required in systems of the type illustrated in FIG. 1 [see 0035] and maintain a fixed positional and/or orientational relationship between said surgical arms 110 and the platform 118 before, during, and after platform movement [see 0040].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by tracking the end effector of the robotic arm and detect movement of the end effector from the pre-determined position and orientation with respect to the patient; to confirm its understanding of the position and orientation of such components [see 0033, Stefanchik et al].
Regarding claim 8, Kuduvalli et al disclose wherein the imaging device includes a support structure supporting the imaging gantry, the imaging gantry supporting the one or more imaging components (kV imaging source and kV imaging detector) arranged for movement relative to the support structure to obtain imaging data of the patient [see 0038, 0040, 0045, 0056] by disclosing each of the kV imaging source and kV imaging detector may be slidably coupled toa single continuous beam member that extends outwardly at a fixed orientation [see 0040];
Regarding claim 9, Kuduvalli et al disclose wherein the imaging device includes a base (gantry frame 1851) [see abstract, fig 18A];
Kuduvalli et al disclose wherein the support structure is configured to linearly translate along the base to obtain the imaging data the patient positioned on the patient support [see fig 18A].
Regarding claims 10, 12, Kuduvalli et al disclose system for performing robotically-assisted surgery, comprising:
a patient support for supporting a patient above a ground surface [see 0037 and figs 5-7, 9,12, 17A, 18A-18D];
the imaging gantry supporting an x- ray source and an x-ray detector arranged for movement relative to the gantry to obtain imaging data of the patient [see 0038, 0040, 0045, 0056] by disclosing each of the kV imaging source and kV imaging detector may be slidably coupled toa single continuous beam member that extends outwardly at a fixed orientation [see 0040];
a motion tracking apparatus configured to track at least one of the patient and the imaging device [see 0034];
a robotic arm having a first end supporting an end effector and configured to extend into an imaging area of imaging gantry [see figs 2A-4, 11-12].
Kuduvalli et al don’t disclose an imaging device including a support structure supporting an imaging gantry for linear movement along a longitudinal axis of the patient support
Nonetheless, Heuscher discloses an imaging device including a support structure supporting an imaging gantry for linear movement along a longitudinal axis of the patient support [see 0023 and fig 1] by disclosing support 126 is stationary while the rotating gantry 104 is axially movable along tracks 128 that run parallel to the axis 120, which enables an operator of the system to suitably define the VOI to encompass the whole subject or a portion thereof for scanning [see 0023]
Kuduvalli et al and Heuser don’t disclose a second end operatively attached to the patient support, the robotic arm being configured to avoid collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus.
Nonetheless, Stefanchik et al disclose the robotic arm being configured to avoid (by having the awareness of the position and orientation of end effector, etc., emphasis added) collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus [see 0033-0035, 0040-0043] by disclosing the controller can have an awareness of the position and orientation of the platform 118 relative to the support frame 108 or other components of the robot 104 (e.g., the surgical arms 110 to which the various end effectors 116 are coupled) and when the position or orientation of the platform 118 is adjusted and the controller 106 can automatically make corresponding adjustments to the position or orientation of one or more of the end effectors 116 [see 0034].
a second end operatively attached to the patient support [see figs 3, 5].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by moving the imaging gantry along the longitudinal axis of the patient support; to enable an operator of the system to suitably define the VOI to encompass the whole subject or a portion thereof for scanning [see 0023, Heuser] and by a second end operatively attached to the patient support, the robotic arm being configured to avoid collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus; so that the controller 106 can automatically make corresponding adjustments to the position or orientation of one or more of the end effectors 116 [see 0034 Stefanchik et al].
Regarding claims 13-14, Kuduvalli et al and Heuser don’t disclose tracking the end effector of the robotic arm and detect movement of the end effector from the pre-determined position and orientation with respect to the patient.
Nonetheless, Stefanchik et al disclose tracking the end effector of the robotic arm and detect movement of the end effector from the pre-determined position and orientation (fixed frame of reference) with respect to the patient [see 0033-0035, 0040] by disclosing it will thus be appreciated that movement of the platform 118, whether inadvertent or intentional, can be detected by the controller 106 and compensated for, without the need for the cumbersome and complicated recalibration procedures required in systems of the type illustrated in FIG. 1 [see 0035] and maintain a fixed positional and/or orientational relationship between said surgical arms 110 and the platform 118 before, during, and after platform movement [see 0040].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by tracking the end effector of the robotic arm and detect movement of the end effector from the pre-determined position and orientation with respect to the patient; to confirm its understanding of the position and orientation of such components [see 0033, Stefanchik et al].
Regarding claim 17, Kuduvalli et al disclose wherein the robotic arm, the imaging device, and the motion tracking apparatus operate in a common coordinate system [see 0034].
Regarding claim 18, Kuduvalli et al disclose system for performing robotically-assisted surgery, comprising:
a patient support coupled to a column for supporting a patient above a ground surface [see 0037 and figs 5-7, 9,12, 17A, 18A-18D];
the imaging gantry supporting one or more imaging components arranged for movement relative to the support structure to obtain imaging data of the patient [see 0038, 0040, 0045, 0056] by disclosing each of the kV imaging source and kV imaging detector may be slidably coupled toa single continuous beam member that extends outwardly at a fixed orientation [see 0040];
a motion tracking apparatus configured to track at least one of the patient and the imaging device [see 0034];
a robotic arm having an end effector and configured to extend into an imaging area of imaging gantry [see figs 2A-4, 11-12].
Kuduvalli et al don’t disclose an imaging device including a support structure supporting an imaging gantry for linear movement along a longitudinal axis of the patient support
Nonetheless, Heuscher discloses an imaging device including a support structure supporting an imaging gantry for linear movement along a longitudinal axis of the patient support [see 0023 and fig 1] by disclosing support 126 is stationary while the rotating gantry 104 is axially movable along tracks 128 that run parallel to the axis 120, which enables an operator of the system to suitably define the VOI to encompass the whole subject or a portion thereof for scanning [see 0023]
Kuduvalli et al and Heuser don’t disclose a robotic arm being configured to avoid collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus.
Nonetheless, Stefanchik et al disclose the robotic arm being configured to avoid (by having the awareness of the position and orientation of end effector, etc., emphasis added) collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus [see 0033-0035, 0040-0043] by disclosing the controller can have an awareness of the position and orientation of the platform 118 relative to the support frame 108 or other components of the robot 104 (e.g., the surgical arms 110 to which the various end effectors 116 are coupled) and when the position or orientation of the platform 118 is adjusted and the controller 106 can automatically make corresponding adjustments to the position or orientation of one or more of the end effectors 116 [see 0034].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher and Stefanchik et al by moving the imaging gantry along the longitudinal axis of the patient support; to enable an operator of the system to suitably define the VOI to encompass the whole subject or a portion thereof for scanning [see 0023, Heuser] and by having a robotic arm being configured to avoid collisions with the imaging device and with the patient in response to relative movement occurring between the imaging device and patient detected by the motion tracking apparatus; so that the controller 106 can automatically make corresponding adjustments to the position or orientation of one or more of the end effectors 116 [see 0034 Stefanchik et al].
Regarding claim 19, Kuduvalli et al disclose wherein the one or more imaging components includes an emitter and a detector [see 0032] by disclosing One or more imaging (kV) radiation sources 110 selectively emit relatively low-energy x-ray imaging radiation under the control of kV radiation controller 126, the imaging radiation being captured by one or more imaging detectors 112 [see 0032].
Claim(s) 6-7, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kuduvalli et al (Pub. No.: US 2012/0035470) in view of Heuscher (Pub. No.: US 2010/0274120) and further in view of Stefanchik et al (Pub. No.: US 2013/0085510) as applied to claims 1 and 10 above and further in view of Kostrzewski et al (Pub. No.: US 2015/0100066).
Regarding claims 6, 15, Kuduvalli et al, Heuser Stefanchik et al don’t disclose notifying a user with a notification device configured to generate an alarm in response to detecting movement of the end effector from the pre-determined position and orientation with respect to the patient.
Nonetheless, Kostrzewski et al disclose notifying a user with a notification device configured to generate an alarm in response to detecting movement of the end effector from the pre-determined position and orientation with respect to the patient [see 0015-0016] by disclosing
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher, Stefanchik et al and Kostrzewski et al by notifying a user with a notification device configured to generate an alarm in response to detecting movement of the end effector from the pre-determined position and orientation with respect to the patient; in order to require additional checks be performed, and/or requires user confirmation [see 0015, Kostrzewski et al].
Regarding claims 7, 16, Kuduvalli et al, Heuser Stefanchik et al don’t disclose stopping movement of the imaging device when movement of the end effector from the pre-determined position and orientation with respect to the patient is detected.
Nonetheless, Kostrzewski et al disclose stopping movement of the imaging device when movement of the end effector from the pre-determined position and orientation with respect to the patient is detected [see 0015-0016, 0087] by disclosing supervisory interlock system, in some implementations, is configured to brake any movement of the robotic arm upon detection by the supervisory interlock system of an anomaly or problem [see 0015-0016]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher, Stefanchik et al and Kostrzewski et al by stopping movement of the imaging device when movement of the end effector from the pre-determined position and orientation with respect to the patient is detected; in order to require additional checks be performed, and/or requires user confirmation [see 0015, Kostrzewski et al].
Claim(s) 11, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuduvalli et al (Pub. No.: US 2012/0035470) in view of Heuscher (Pub. No.: US 2010/0274120) and further in view of Stefanchik et al (Pub. No.: US 2013/0085510) as applied to claims 10 and 18 above and further in view of Langan et al (Pub. No.: US 2014/0037049).
Regarding claims 11, 20, Kuduvalli et al, Heuser Stefanchik et al don’t disclose wherein the imaging gantry of the imaging device is configured to tilt with respect to the support structure.
Nonetheless, Langan et al disclose wherein the imaging gantry of the imaging device is configured to tilt with respect to the support structure [see 0020, 0045, 0052] by disclosing the gantry can be positioned at a specific angular orientation, tilt angle [see 0020]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kuduvalli et al, Heuscher, Stefanchik et al and Langan et al by tilting the gantry with respect to the support structure; in order to enable imaging during an interventional procedure [see 0020, Langan et al].
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798