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 .
Information Disclosure Statement
The references listed on the IDS filed 8/21/2025, 10/29/2025, and 5/11/2026 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, claim 10 recites the limitation “wherein the first robotic arm is configured to carry a first component and the second robotic arm is configured to carry a second component in a fixed spatial relationship, such that the pose of the first component and the second component is known relative to the subject.”
The limitation is unclear regarding what the second component is carried in a fixed relationship to. It could conceivably refer to the first component, the second robotic arm, the subject, or something else.
The specification does not provide clarity regarding this limitation. The only mention of a “fixed spatial relationship” comes in Fig. 3 paragraph [0012] and refers to the pose of a tool holder and image detection plate which are mounted to the same robotic arm.
Since the first and second arms can move relative to each other, there is no support for the first and second components being in a fixed spatial relationship while attached to separate arms. Because the fixed spatial relationship of Fig. 3 and [0012] is described in dependent claim 14, Examiner assumes that this is not what is intended in claim 10.
It is therefore unclear what is intended by the limitation of “the second robotic arm is configured to carry a second component in a fixed spatial relationship,”
Therefore, claims 10-17 are rejected under 35 USC 112(a).
For the sake of expediting prosecution, the Examiner will be evaluating claim 10 without the limitation of “in a fixed spatial relationship.”
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4, 7, and 10-14 of U.S. Patent No. 12,268,457. This is a statutory double patenting rejection.
Regarding claim 1, Zehavi ‘457 teaches: A robotic surgical system comprising:
a first robotic arm configured to orient a first component; (See Zehavi ‘457 claim 1) and
a second robotic arm mounted in a known position relative to the first robotic arm, and configured to orient a second component, wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm, (See Zehavi ‘457 claim 1 for known mechanical arrangement)
wherein the known mechanical arrangement is defined by the first robotic arm connected to a common base with the second robotic arm, and (See Zehavi ‘457 claim 1 for common base)
wherein a pose of the first robotic arm and the first component and a pose of the second robotic arm and the second component are known relative to a subject. (See Zehavi ‘457 claim 1 for positioning of the subject between the first and second arm to generated images, and position of the surgical tool or tool holder known relative to the images generated of the subject.)
Regarding claim 2, Zehavi ‘457 teaches: The robotic surgical system of claim 1, wherein the first component comprises an imaging device (See Zehavi claim 1) and the second component comprises a surgical tool or a surgical tool holder. (See Zehavi claim 1 for second arm further configured to carry surgical tool or tool holder)
Regarding claim 3, Zehavi ‘457 teaches: The robotic surgical system according to claim 2, wherein the surgical tool comprises at least one of a surgical scalpel, a surgical drill, a guide tube, and a retractor. (See Zehavi ‘457 claim 7)
Regarding claim 4, Zehavi ‘457 teaches: The robotic surgical system of claim 1, wherein the first component comprises an imager source and the second component comprises an imager detection element, and wherein when the subject is positioned between the first robotic arm and the second robotic arm, images of a region of interest of the subject can be generated. (See Zehavi ‘457 claim 1)
Regarding claim 5, Zehavi ‘457 teaches: The robotic surgical system of claim 4, wherein the second robotic arm is further configured to carry a surgical tool or a surgical tool holder and the imager detection element in a fixed spatial relationship, such that a pose of the surgical tool or the surgical tool holder is known relative to the images generated of the subject. (See Zehavi ‘457 claim 1)
Regarding claim 6, Zehavi ‘457 teaches: The robotic surgical system of claim 5, wherein the second robotic arm comprises an attachment element adapted to be attached either to the surgical tool or the surgical tool holder, the attachment element being such that the fixed spatial relationship between the surgical tool or the tool holder and the imager detection element is accurately known. (See Zehavi ‘457 claim 2)
Regarding claim 7, Zehavi ‘457 teaches: The robotic surgical system according to claim 4, where the imager source is either an X-ray imager or an ultrasound imager. (See Zehavi ‘457 claim 4)
Regarding claim 8, Zehavi ‘457 teaches: The robotic surgical system according to claim 1, wherein the pose of the first robotic arm and the first component and the pose of the second robotic arm and the second component being known relative to the subject enables autonomous guidance of the first component and the second component to a position on the subject, determined by a user. (See Zehavi ‘457 claim 3 for autonomous guidance)
Regarding claim 9, Zehavi ‘457 teaches: The robotic surgical system according to claim 1, further comprising a third robotic arm whose co-ordinate system is co-related to those of the first robotic arm and the second robotic arm, and which is adapted to hold additional surgical elements. (See Zehavi ‘457 claim 4)
Regarding claim 10, Zehavi ‘457 teaches: A robotic surgical system comprising:
at least a first robotic arm and a second robotic arm, the first robotic arm and the second robotic arm being mutually mounted such that their co-ordinate systems are known relative to each other, the first robotic arm being disposed on a first side of a support element and the second robotic arm being disposed on a second side of the support element on which a subject is to be positioned, (See Zehavi ‘457 claim 10)
wherein the second robotic arm is mounted in a known position relative to the first robotic arm, (See Zehavi ‘457 claim 10)
wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm, (See Zehavi ‘457 claim 10)
wherein the known mechanical arrangement is defined by the first robotic arm being connected to a common base with the second robotic arm, and (See Zehavi ‘457 claim 10)
wherein the first robotic arm is configured to carry a first component and the second robotic arm is configured to carry a second component [in a fixed spatial relationship], such that a pose of the first component and the second component is known relative to the subject. (See Zehavi ‘457 claim 10 for positioning of the subject between the first and second arm to generated images, and position of the surgical tool or tool holder known relative to the images generated of the subject.)
Regarding claim 11, Zehavi ‘457 teaches: The robotic surgical system of claim 10, wherein the first component comprises an imaging device and the second component comprises a surgical tool or a surgical tool holder. (See Zehavi ‘457 claim 10)
Regarding claim 12, Zehavi ‘457 teaches: The robotic surgical system of claim 10, wherein the first component comprises an imager source and the second component comprises an imager detection element, and wherein when the subject is positioned between the first robotic arm and the second robotic arm, images of a region of interest of the subject can be generated. (See Zehavi ‘457 claim 10)
Regarding claim 13, Zehavi ‘457 teaches: The robotic surgical system of claim 12, wherein the second robotic arm is further configured to carry a surgical tool or a surgical tool holder and the imager detection, such that a pose of the surgical tool or the surgical tool holder is known relative to the images generated of the subject. (See Zehavi ‘457 claim 10)
Regarding claim 14, Zehavi ‘457 teaches: The robotic surgical system of claim 13, wherein the second robotic arm comprises an attachment element adapted to be attached either to the surgical tool or the surgical tool holder, the attachment element being such that the fixed spatial relationship between the surgical tool or tool holder and the imager detection element is accurately known. (See Zehavi ‘457 claims 10 and 2)
Regarding claim 15, Zehavi ‘457 teaches: The robotic surgical system according to claim 12, where the imager source is either an X-ray imager or an ultrasound imager. (See Zehavi ‘457 claim 11)
Regarding claim 16, Zehavi ‘457 teaches: The robotic surgical system according to claim 10, wherein the pose of the first robotic arm and the first component and the pose of the second robotic arm and the second component being known relative to the subject enables autonomous guidance of the first component and the second component to a position on the subject, determined by a user. (See Zehavi ‘457 claims 10 and 3)
Regarding claim 17, Zehavi ‘457 teaches: The robotic surgical system according to claim 10, further comprising a third robotic arm whose co-ordinate system is co-related to those of the first robotic arm and the second robotic arm, and which is adapted to hold additional surgical elements. (See Zehavi ‘457 claims 10 and 4)
Regarding claim 18, Zehavi ‘457 teaches: A method of performing a surgical procedure on a region of a subject, comprising:
orienting a first component attached to a first robotic arm;
orienting a second component attached to a second robotic arm, wherein the second robotic arm is mounted in a known position relative to the first robotic arm, wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm, and wherein the known mechanical arrangement is defined by the first robotic arm being on a common base with the second robotic arm; and
using the first component carried on the first robotic arm and the second component carried on the second robotic arm to implement the surgical procedure, wherein a pose of the first component and the second component is known relative to at least one image generated of the subject. (See Zehavi ‘457 claim 12 for first and second arms on common base, with first and second components (image source and detector elements) mounted on first and second arms, used to implement surgical procedure, with pose of components known relative to image generated of the subject)
Regarding claim 19, Zehavi ‘457 teaches: The method according to claim 18, wherein the surgical procedure is performed using intraoperative alignment of a tool trajectory in the at least one image generated having a co-ordinate system common to that of the first component and the second component. (See Zehavi ‘457 claim 13)
Regarding claim 20, Zehavi ‘457 teaches: The method according to claim 19, wherein determining on the at least one image the tool trajectory includes determining on the at least one image the tool trajectory in real-time. (See Zehavi ‘457 claim 14)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Banks et al. (US 20110276179 A1) in view of Kang (US 20140188132 A1).
Regarding claim 1, Banks teaches: A robotic surgical system (See Banks Fig. 2 and [0010]) comprising:
a first robotic arm configured to orient a first component; (See Banks Fig. 2 and [0010] for robotic arms for imaging and tool holding) and
a second robotic arm mounted in a known position relative to the first robotic arm, and configured to orient a second component, … (See Banks Fig. 2 and [0010] for robotic arms for imaging and tool holding. See [0019] for generation of images within the same coordinate space. See [0023] for calibration and computation of robot locations. )
… and
wherein a pose of the first robotic arm and the first component and a pose of the second robotic arm and the second component are known relative to a subject. (See Banks [0026] for spatial registration of robots, patient, table used to generate scan trajectory.)
Banks does not explicitly teach:
…wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm,
wherein the known mechanical arrangement is defined by the first robotic arm connected to a common base with the second robotic arm, …
Examiner notes that Banks teaches the first and second robotic arms mounted to the structure of a room in a static manner, which could be interpreted as a common base in a known mechanical arrangement.
However, Kang teaches a multi-armed robotic surgery system, wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm,
wherein the known mechanical arrangement is defined by the first robotic arm connected to a common base with the second arm, (See Kang Fig. 8A and [0075] for multi-armed system, including the two parts of an imaging pair on separate arms above and below the operating table, a third arm holding a tool, all connected to a base, and the coordinate systems of the various components may all be kept in registration by monitoring of positions and/or orientation of the various components. See Fig. 8B and [0076] where encoded joints are used to maintain registration. This requires that the physical relationship of the arms be known so that the angle of each joint is all that is needed in order to maintain registration of the coordinate systems.)
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the application, to modify the system of Banks to rely upon a known mechanical arrangement of the robot arms, connected to a common base, as taught in Kang, in order to simplify the calibration process of Banks.
Regarding claim 2, modified Banks teaches: The robotic surgical system of claim 1, wherein the first component comprises an imaging device (See Banks Fig. 2 and [0020] for arms holding imaging devices) and the second component comprises a surgical tool or a surgical tool holder. (See Banks Fig. 2 and [0020] for arm holding surgical tool.)
Regarding claim 3, modified Banks teaches: The robotic surgical system according to claim 2, wherein the surgical tool comprises at least one of a surgical scalpel, a surgical drill, a guide tube, and a retractor. (See Banks Fig. 2 and [00029] for tool holder compatible with common surgical tools including drills. )
Regarding claim 4, modified Banks teaches: The robotic surgical system of claim 1, wherein the first component comprises an imager source and the second component comprises an imager detection element, and wherein when the subject is positioned between the first robotic arm and the second robotic arm, images of a region of interest of the subject can be generated. (See Banks Fig. 2 and [0020] first arm with x-ray source, second arm with x-ray receiver, positioned above and below patient)
Regarding claim 7, modified Banks teaches: The robotic surgical system according to claim 4, where the imager source is either an X-ray imager or an ultrasound imager. (See Banks Fig. 2 and [0020] first arm with x-ray source, second arm with x-ray receiver)
Regarding claim 8, modified Banks teaches: The robotic surgical system according to claim 1, wherein the pose of the first robotic arm and the first component and the pose of the second robotic arm and the second component being known relative to the subject enables autonomous guidance of the first component and the second component to a position on the subject, determined by a user. (See Banks [0026] for automatic operation of the arms, [0030] for image guidance of tools)
Regarding claim 9, modified Banks teaches: The robotic surgical system according to claim 1, further comprising a third robotic arm whose co-ordinate system is co-related to those of the first robotic arm and the second robotic arm, and which is adapted to hold additional surgical elements. (See Banks Fig. 2 and [0020] for third tool holding robotic arm)
Regarding claim 10, Banks teaches: A robotic surgical system comprising:
at least a first robotic arm and a second robotic arm, the first robotic arm and the second robotic arm being mutually mounted such that their co-ordinate systems are known relative to each other, the first robotic arm being disposed on a first side of a support element and the second robotic arm being disposed on a second side of the support element on which a subject is to be positioned, (See Banks Fig. 2 and [0020] for robotic arms for imaging and tool holding arranged around patient bed. See [0019] for generation of images within the same coordinate space. See [0023] for calibration and computation of robot locations. )
wherein the second robotic arm is mounted in a known position relative to the first robotic arm, ( See Banks [0023] for calibration and computation of robot locations. )
…
wherein the first robotic arm is configured to carry a first component and the second robotic arm is configured to carry a second component [in a fixed spatial relationship], such that a pose of the first component and the second component is known relative to the subject. (See Banks Fig. 2 and [0020] for robotic arms for imaging and tool holding. See [0026] for spatial registration of robots, patient, table used to generate scan trajectory.)
Banks does not explicitly teach:
…wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm,
wherein the known mechanical arrangement is defined by the first robotic arm connected to a common base with the second robotic arm, …
Examiner notes that Banks teaches the first and second robotic arms mounted to the structure of a room in a static manner, which could be interpreted as a common base in a known mechanical arrangement.
However, Kang teaches a multi-armed robotic surgery system, wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm,
wherein the known mechanical arrangement is defined by the first robotic arm connected to a common base with the second arm, (See Kang Fig. 8A and [0075] for multi-armed system, including the two parts of an imaging pair on separate arms above and below the operating table, a third arm holding a tool, all connected to a base, and the coordinate systems of the various components may all be kept in registration by monitoring of positions and/or orientation of the various components. See Fig. 8B and [0076] where encoded joints are used to maintain registration. This requires that the physical relationship of the arms be known so that the angle of each joint is all that is needed in order to maintain registration of the coordinate systems.)
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the application, to modify the system of Banks to rely upon a known mechanical arrangement of the robot arms, connected to a common base, as taught in Kang, in order to simplify the calibration process of Banks.
Examiner notes that, if the limitation of “in a fixed spatial relationship,” was intended to mean the relationship between the first and second components, respectively carried by the first and second robotic arms, then this limitation would be taught by Popovic (US 20190307519 A1), which teaches maintaining fixed distance and angular orientation between two surgical arms.
Regarding claim 11, modified Banks teaches: The robotic surgical system of claim 10, wherein the first component comprises an imaging device (See Banks Fig. 2 and [0020] for arms holding imaging devices) and the second component comprises a surgical tool or a surgical tool holder. (See Banks Fig. 2 and [0020] for arm holding surgical tool.)
Regarding claim 12, modified Banks teaches: The robotic surgical system of claim 10, wherein the first component comprises an imager source and the second component comprises an imager detection element, and wherein when the subject is positioned between the first robotic arm and the second robotic arm, images of a region of interest of the subject can be generated. (See Banks Fig. 2 and [0020] first arm with x-ray source, second arm with x-ray receiver, positioned above and below patient)
Regarding claim 13, modified Banks teaches: The robotic surgical system of claim 12, wherein the second robotic arm is further configured to carry a surgical tool or a surgical tool holder and the imager detection, such that a pose of the surgical tool or the surgical tool holder is known relative to the images generated of the subject. (See Kang Fig. 3A and [0055] where a second movable structure 40 is mounted to the imaging component and has an instrument 38. Registration is maintained between all relevant coordinate systems, therefore the spatial relationships of all components are known.)
Regarding claim 15, modified Banks teaches: The robotic surgical system according to claim 12, where the imager source is either an X-ray imager or an ultrasound imager. (See Banks Fig. 2 and [0020] first arm with x-ray source, second arm with x-ray receiver)
Regarding claim 16, modified Banks teaches: The robotic surgical system according to claim 10, wherein the pose of the first robotic arm and the first component and the pose of the second robotic arm and the second component being known relative to the subject enables autonomous guidance of the first component and the second component to a position on the subject, determined by a user. (See Banks [0026] for automatic operation of the arms, [0030] for image guidance of tools)
Regarding claim 17, modified Banks teaches: The robotic surgical system according to claim 10, further comprising a third robotic arm whose co-ordinate system is co-related to those of the first robotic arm and the second robotic arm, and which is adapted to hold additional surgical elements. (See Banks Fig. 2 and [0020] for third tool holding robotic arm)
Regarding claim 18, Banks teaches: A method of performing a surgical procedure on a region of a subject, comprising:
orienting a first component attached to a first robotic arm;
orienting a second component attached to a second robotic arm, wherein the second robotic arm is mounted in a known position relative to the first robotic arm, … and (See Banks Fig. 2 and [0010] for robotic arms for imaging and tool holding. See [0019] for generation of images within the same coordinate space. See [0023] for calibration and computation of robot locations. )
using the first component carried on the first robotic arm and the second component carried on the second robotic arm to implement the surgical procedure, wherein a pose of the first component and the second component is known relative to at least one image generated of the subject. (See Banks [0026] for spatial registration of robots, patient, table used to generate scan trajectory.)
Banks does not explicitly teach:
wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm, and wherein the known mechanical arrangement is defined by the first robotic arm being on a common base with the second robotic arm;
Examiner notes that Banks teaches the first and second robotic arms mounted to the structure of a room in a static manner, which could be interpreted as a common base in a known mechanical arrangement.
However, Kang teaches a multi-armed robotic surgery system, wherein the known position of the second robotic arm relative to the first robotic arm is based on a known mechanical arrangement connecting the first robotic arm and the second robotic arm,
wherein the known mechanical arrangement is defined by the first robotic arm connected to a common base with the second arm, (See Kang Fig. 8A and [0075] for multi-armed system, including the two parts of an imaging pair on separate arms above and below the operating table, a third arm holding a tool, all connected to a base, and the coordinate systems of the various components may all be kept in registration by monitoring of positions and/or orientation of the various components. See Fig. 8B and [0076] where encoded joints are used to maintain registration. This requires that the physical relationship of the arms be known so that the angle of each joint is all that is needed in order to maintain registration of the coordinate systems.)
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the application, to modify the system of Banks to rely upon a known mechanical arrangement of the robot arms, connected to a common base, as taught in Kang, in order to simplify the calibration process of Banks.
Regarding claim 19, modified Banks teaches: The method according to claim 18, wherein the surgical procedure is performed using intraoperative alignment of a tool trajectory in the at least one image generated having a co-ordinate system common to that of the first component and the second component. (See Banks [0019] for third arm with tool holder to implement image-guided surgical plan. See [0028] for alignment of third arm with ideal trajectory. See [0023] for the computation of base reference frames with respect to the source so that all robotic arms use a common reference frame.)
Regarding claim 20, modified Banks teaches: The method according to claim 19, wherein determining on the at least one image the tool trajectory includes determining on the at least one image the tool trajectory in real-time. (See Banks [0010] where the system is used for image guided surgery which inherently involves the use of images taken during the procedure to guide the procedure.)
Conclusion
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/JACOB KENT BESTEMAN-STREET/
Examiner, Art Unit 3661
/PETER D NOLAN/Supervisory Patent Examiner, Art Unit 3661
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