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 .
Response to Arguments
Applicant’s arguments filed 05/29/2025 have been fully considered but are not persuasive.
Applicant argues, “there is no teaching or suggestion within Walker regarding a user interface being configured to acquire a spatial positioning of a user input in a time-resolved manner with regard to the graphic display, wherein the user input includes an input gesture as a specification of a movement parameter for the predefined section.”
Examiner respectfully disagrees. Walker discloses
wherein the user interface is configured to acquire a spatial positioning of a user input in a time-resolved manner ([0055]: tracking sensors allow for tracking information to be displayed in real-time through an anatomical image or model) with regard to the graphic display ([0014]: “the user provides the robotic medical system with an identification of the target using a user input device…the user command to drive the instrument is received from the user via a user input device”; [0094]: displays position of the user input device may show displayed images; [0017]: “one or more user inputs received via the user input device”),
wherein the user input specifies a movement parameter ([0014]: “the user command to drive the instrument is received from the user via a user input device”) for the predefined section ([0014]: “navigating a distal tip of a flexible inner member of the medical instrument to the target”),
wherein the user input comprises an input gesture as a specification of the movement parameter for the predefined section ([0094]: a user input device configured to detect input gestures and also allows an assistant to choose target locations at a remote workstation while a physician continues the navigation bedside) and a movement parameter ([0070]: user can drive or manipulate objects relative to other objects).
Applicant argues, “while Walker discloses a color on or around a target being changed, there is no teaching or suggestion for any scaling, windowing, or transformation of a dataset regarding an imaging level or direction of view”.
Examiner respectfully disagrees. Walker discloses
wherein, when the predefined section is in the at least one first defined area ([0115]: “when the instrument is aligned with the target”), the apparatus is configured to
adjust the graphic display ([0115]: the color on or around the target can be changed to green when the instrument is aligned with the target, i.e., the apparatus is configured to adjust the graphic display; [0014]: image may be displayed in different viewing angles; [0074]: viewing angle may also rotate depending on user input) and
provide a recording parameter to a medical imaging device for recording a further dataset ([0098]: once outer member is aligned, inner member may be automatically positioned to align with an inner member target, which would provide a new recording parameter for the inner member; [0064]: inner member is tracked)
wherein the adjustment of the graphic display is a scaling, windowing, and/or transformation of the dataset with regard to an imaging level and/or direction of view of the graphic display ([0014]: image may be displayed in different viewing angles which would be a transformation regarding direction of view of the graphic display; [0074]: viewing angle may also rotate depending on user input).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 8-16, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker et al. (US 2017/0151027).
In re claim 1, Walker discloses an apparatus (apparatus shown in Figs. 1 and 3) for moving [0042-0043] a medical object (Fig. 3: medical instrument 18), the apparatus comprising:
a robotic apparatus (fig. 3: comprising robotic arm 20 and instrument driver 22) for robotic movement of the medical object (Fig. 3; [0049]); and
a user interface (fig. 3; user workstation 31, [0050]: 31 includes user input device 33; [0053]),
wherein, in an operating state of the apparatus, a predefined section (fig. 7: the distal tip of medical instrument 18, i.e., the portion where tracking sensors 714, 724, and 734 are located) of the medical object is configured to be arranged in an examination region ([0045-0046]: 18 is located in an “anatomical space”; [0042]) of an examination object ([0045]: “a patient”),
wherein the apparatus is configured to receive a dataset ([0051]: comprising the set of data received, generated, and used by controller 34) having an image ([0045]: images of the anatomical space) and/or a model ([0055]: image or model of the anatomy; [0077]: 3-D model of the anatomy is generated from pre-operative imaging) of the examination region [0045, 0055, 0077],
wherein the apparatus is configured to receive and/or determine positioning information for a spatial positioning of the predefined section of the medical object ([0055]: the “tracking sensors” are located on the predefined section and provide real-time sensing of instrument’s position, see above),
wherein the user interface is configured to display a graphic display of the predefined section of the medical object with regard to the examination region based on the dataset and the positioning information ([0014]: “superimposing the current location and position of at least a portion of the medical instrument on the registered images includes overlaying a graphical representation of the instrument on at least two different images…”; [0055, 0073]),
wherein the user interface is configured to acquire a spatial positioning of a user input in a time-resolved manner ([0055]: tracking sensors allow for tracking information to be displayed in real-time through an anatomical image or model) with regard to the graphic display ([0014]: “the user provides the robotic medical system with an identification of the target using a user input device…the user command to drive the instrument is received from the user via a user input device”; [0094]: displays position of the user input device may show displayed images; [0017]: “one or more user inputs received via the user input device”),
wherein the user input specifies a movement parameter ([0014]: “the user command to drive the instrument is received from the user via a user input device”) for the predefined section ([0014]: “navigating a distal tip of a flexible inner member of the medical instrument to the target”),
wherein the user input comprises an input gesture as a specification of the movement parameter for the predefined section ([0094]: a user input device configured to detect input gestures and also allows an assistant to choose target locations at a remote workstation while a physician continues the navigation bedside) and a movement parameter ([0070]: user can drive or manipulate objects relative to other objects; see above),
wherein the user interface is configured to associate the user input spatially and temporally with the graphic display of the predefined section ([0014]: the user input can used to control the position of the instrument; [0055]: states that “the representation of the elongate instrument can be displayed moving in real-time in an anatomical image or model,” i.e., the graphic display is updated in real time according to its current position—it follows that, when the instrument is controlled by the user input, that input is spatially and temporally associated with the graphic display; thus, the user interface must be configured to associate the user input both spatially and temporally with the graphic display of the predefined section in order to provide the real-time position of the instrument on the display)
wherein the apparatus is further configured to determine a control instruction based on the user input ([0014]: “calculating a suitable movement includes calculating one or a series of bends, rolls, insertions, and/or retractions needed to move the instrument from its current location to or towards the target”; [0060]: “the system calculates one movement or a series of movements required for the instrument to move from its current position toward, to, or through the target”), and
wherein the robotic apparatus is configured to move the medical object in accordance with the control instruction ([0013] “navigating or assisting a user in navigating the medical instrument to the target based, at least in part, on the calculated movement”).
In re claim 2, Walker discloses the apparatus of claim 1,
wherein the dataset further has an image ([0076]: “tracking the elongate instrument via computer vision in a fluoroscopy image”) and/or a model ([0073]: “[the] tracked instrument is simulated by rendering it with 3-D computer graphics” i.e., a model of the predefined section) of the predefined section [0073, 0076],
wherein the apparatus is further configured to determine the positioning information based on the dataset ([0073]: the model is used to position the predefined section of the medical object; [0076]: “the accuracy of the virtual instrument 920 may be improved…”).
In re claim 3, wherein the apparatus is configured to determine, based on the user input, the control instruction having an instruction for
a forward movement ([0060]: “axial translation”) and/
or backward movement [0060]: “axial translation”) and/or
rotational movement ([0060]: “articulation (e.g., a bend and a roll)”) of the medical object [0060].
In re claim 4, Walker discloses
wherein the user interface is configured to acquire the user input repeatedly and/or continuously ([0108-0110]: the apparatus can be configured to allow a user to control the movement of the medical object directly through user inputs which would be acquired repeatedly and/or continuously to accommodate moving the medical object in response to the user’s inputs), and
wherein the apparatus is further configured to determine and/or adjust the control instruction based on a last user input acquired in each case ([0108-0110]: the system would have to adjust the control instruction based on the last user input since the robot is directly controlled by the user; [0060]: “the system calculates one movement or a series of movements…on-demand after a specific event or action is taken by the user” i.e., determine and/or adjust the control instruction based on a last user input).
In re claim 6, Walker discloses
wherein the user interface has an input display ([0050]: comprising user input device 33 and visual display 35), and
wherein the input display is configured to acquire the user input on a touch-sensitive surface of the input display ([0050]: 33 and 35 can comprise a touchscreen for “receiving commands from, and interfacing with, a user”).
In re claim 8, Walker discloses
wherein the dataset comprises planning information ([0094]: after the user designates the target position, the system “computes the target position, heading, ostium shape, vessel centerline, or other information useful for navigation” this information is considered planning information because it represents the planned trajectory of the medical object through the anatomical space; it includes the digital location of the target position and the desired path that the instrument should take, e.g., shown in Figs. 13 and 15A-D) for movement of the medical object [0094],
wherein the planning information has at least one first defined area in the dataset ([0116]: the area immediately surrounding the target position; Fig. 9: rectangle 940 around target 915),
wherein the apparatus is configured to identify based on the positioning information and of the dataset whether the predefined section is arranged in the at least one first defined area ([0115]: states that the position of the medical object can be monitored relative to the target, i.e., the at least one first defined area; this functionality would require using the positioning information, the image/model of the examination region (i.e., the dataset), and the planning information (i.e., the dataset), [0070]: “registration”),
wherein, when the predefined section is in the at least one first defined area ([0115]: “when the instrument is aligned with the target”), the apparatus is configured to
adjust the graphic display ([0115]: the color on or around the target can be changed to green when the instrument is aligned with the target, i.e., the apparatus is configured to adjust the graphic display; [0014]: image may be displayed in different viewing angles; [0074]: viewing angle may also rotate depending on user input) and
provide a recording parameter to a medical imaging device for recording a further dataset ([0098]: once outer member is aligned, inner member may be automatically positioned to align with an inner member target, which would provide a new recording parameter for the inner member; [0064]: inner member is tracked)
wherein the adjustment of the graphic display is a scaling, windowing, and/or transformation of the dataset with regard to an imaging level and/or direction of view of the graphic display ([0014]: image may be displayed in different viewing angles which would be a transformation regarding direction of view of the graphic display; [0074]: viewing angle may also rotate depending on user input).
In re claim 9 Walker discloses
wherein the apparatus is configured to identify geometrical and/or anatomical features in the dataset ([0095]: “the imagery video from an imaging system…may be frame grabbed by the system and then processed using computer vision techniques to determine anatomical features of interest to create targets or provide additional guidance as the user is creating the targets; [0094]: “the system automatically calculates where the targets would be based on known information such as a three-dimensional CT”),
wherein the apparatus is configured to determine at least one defined area in the dataset (the area immediately surrounding the target position, e.g., see [0116] and Fig. 9: rectangle 940 around target 915) based on the identified geometrical and/or anatomical features ([0094-0095]: the identified geometrical and/or anatomical features can be used to create targets),
wherein the apparatus is configured to identify based on the positioning information and the dataset whether the predefined section is arranged in the at least one defined area ([0115]: the position of the medical object can be monitored relative to the target, i.e., the at least one defined area; this functionality would require using the positioning information, the image/model of the examination region (i.e., the dataset), and the planning information (i.e., the dataset); [0070]: “registration”),
wherein, when the predefined section is in the at least one defined area ([0115]: “when the instrument is aligned with the target”), the apparatus is configured to
adjust the graphic display ([0115]: the color on or around the target can be changed to green when the instrument is aligned with the target, i.e., the apparatus is configured to adjust the graphic display; [0014]: image may be displayed in different viewing angles; [0074]: viewing angle may also rotate depending on user input) and
provide a recording parameter to a medical imaging device for recording a further dataset (see in re claim 8 above),
wherein the adjustment of the graphic display is a scaling, windowing, and/or transformation of the dataset with regard to an imaging level and/or direction of view of the graphic display (see in re claim 8 above).
In re claim 10, Walker discloses
wherein the dataset comprises planning information for movement of the medical object (after the target is identified using the geometric and/or anatomical features in the dataset (see above), the location of the target position and the desired path that the instrument should take, e.g., shown in Figs. 13 and 15A-D, are considered planning information because they represent the planned trajectory of the medical object through the anatomical space), and
wherein the apparatus is configured to determine the at least one defined area based on the planning information (the area immediately surrounding the target position, i.e., the at least one defined area, is based on the location of the target, i.e., the planning information, see above).
In re claim 11, Walker discloses a system (the system of Fig. 1) comprising:
a medical imaging device (imaging subsystem 16) configured to record a dataset having an image ([0045: “images of the anatomical space…”) of an examination region ([0045]: “anatomical space”) of an examination object ([0045]: “a patient’s”); and
an apparatus (comprising robotic arm 20, instrument driver 22, and user workstation 31) comprising a user interface (31) and a robotic apparatus (20 and 22) for robotic movement of a medical object (see above, in regards to claim 1),
wherein, in an operating state of the apparatus, at least one predefined section of the medical object is configured to be arranged in the examination region of the examination object (see above, in regards to claim 1),
wherein the apparatus is configured to receive the dataset from the medical imaging device (the “apparatus” uses the images from the medical imaging device throughout the disclosure, which would require it to be received).
Regarding the limitations
wherein the apparatus is configured to receive and/or determine positioning information for a spatial positioning of the predefined section of the medical object,
wherein the user interface is configured to display a graphic display of the predefined section of the medical object with regard to the examination region based on the dataset and the positioning information,
wherein the user interface is configured to acquire a spatial positioning of a user input in a time-resolved manner with regard to the graphic display,
wherein the user input specifies a movement parameter for the predefined section, wherein the user input comprises an input gesture as a specification of the movement parameter for the predefined section,
wherein the user interface is configured to associate the user input spatially and temporally with the graphic display of the predefined section,
wherein the apparatus is further configured to determine a control instruction based on the user input, and
wherein the robotic apparatus is configured to move the medical object in accordance with the control instruction”,
see in re claim 1 above.
In re claim 12, regarding the limitations, “a method for providing a control instruction, the method comprising:
receiving a dataset having an image and/or a model of an examination region of an examination object when a predefined section of a medical object is arranged in the examination region of the examination object;
receiving and/or determining positioning information about a spatial positioning of the predefined section; displaying a graphic display of the predefined section of the medical object with regard to the examination region based on the dataset and the positioning information;
acquiring a spatial positioning of a user input in a time-resolved manner with regard to the graphic display, wherein the user input specifies a movement parameter for the predefined section, wherein the user input comprises an input gesture as a specification of the movement parameter for the predefined section, and
wherein the user input is associated spatially and temporally with the graphic display of the predefined section
determining the control instruction based on the user input,
wherein the control instruction has an instruction for controlling a robotic apparatus”,
see in re claim 1 above.
Regarding the limitations,
“wherein the robotic apparatus is configured to hold and/or to move the medical object arranged at least partly in the robotic apparatus by transmitting a force in accordance with the control instruction; and
providing the control instruction”,
Walker discloses
wherein the movement apparatus is configured to hold and/or to move the medical object [0049] arranged at least partly in the movement apparatus (Fig. 3) by transmitting a force in accordance with the control instruction [0049, 0113] and
providing the control instruction [0049, 0113].
In re claim 13, regarding the limitations, “wherein the dataset further comprises an image and/or a model of the predefined section, and wherein the positioning information is determined based on the dataset”, see in re claim 2 above.
In re claim 14, regarding the limitations,
“wherein the dataset further comprises planning information for a planned movement of the medical object,
wherein the planning information has at least one first defined area in the dataset, and
wherein the method further comprises:
identifying, based on the positioning information and the dataset, whether the predefined section is arranged in the at least one first defined area; and
adjusting the graphic display and providing a recording parameter to a medical imaging device for recording a further dataset when the predefined section is arranged in the at least one first defined area,
wherein the adjusting of the graphic display is a scaling, windowing, and/or transformation of the dataset with regard to an imaging level and/or direction of view of the graphic display”,
see in re claim 8 above.
In re claim 15, regarding the limitations,
“wherein geometrical and/or anatomical features are identified in the dataset, wherein at least one defined area in the dataset is determined based on the identified geometrical and/or anatomical features, and
wherein the method further comprises:
identifying, based on the positioning information and the dataset, whether the predefined section is arranged in the at least one defined area, and adjusting the graphic display and
providing a recording parameter to a medical imaging device for recording a further dataset when the predefined section is arranged in the at least one defined area,
wherein the adjusting of the graphic display is a scaling, windowing, and/or transformation of the dataset with regard to an imaging level and/or direction of view of the graphic display”,
see in re claim 9 above.
In re claim 16, regarding the limitations,
“wherein the dataset comprises planning information for a planned movement of the medical object, and
wherein the at least one defined area is additionally determined based on the planning information”, see in re claim 10 above.
In re claim 23, Walker discloses wherein the apparatus is further configured to translate the user input into the control instruction comprising a plurality of part movements, and wherein each part movement of the plurality of part movements comprises a forward movement, a backward movement, or a rotational movement of the medical object ([0060]: system able to calculate movements based on a desired translation starting at a current position to a target position; [0098]: inner member able to be automatically positioned once a user aligns an outer member, which means control instructions must be translated to at least one of a forward, backward, or rotational movement; [0108]: robot may provide assistance with movement while user maintains some control over motions, which means user input must be translated to control instruction).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US 2017/0151027) in view of Srinivasan et al. (US 2019/0298458).
In re claim 7, Walker discloses
wherein the user interface has
a display ([0050]: visual display 35) and
a sensor ([0050]: user input device 33; since 33 senses inputs from a user, it is considered to be a sensor),
wherein the apparatus is configured to create the graphic display as a 2-D display ([0050]: 35 may be a touch screen, which generates 2-D displays; [0073]),
wherein the display is configured to display the 2-D display [0050 and 0073], and
wherein the sensor is configured to acquire the user input with regard to the 2-D display [0050].
Walker fails to explicitly disclose
wherein the apparatus is configured to create the graphic display as augmented reality and/or virtual reality,
wherein the display is configured to display the augmented reality and/or the virtual reality, and
wherein the input device or sensor is configured to acquire the user input with regard to the augmented reality and/or the virtual reality.
Srinivasan teaches a surgical robotic system (fig. 16A: 110) and an apparatus (the apparatus shown in Figs. 16A and 17)
configured to create a graphic display ([0124]: “the displays 202 can display a 3D model of the patient's luminal network and virtual navigation information”) as augmented reality and/or virtual reality ([0124]: when 202 comprises “virtual reality viewing devices,” the graphic display would be augmented reality and/or virtual reality),
wherein a display is configured to display the augmented reality and/or the virtual reality [0124], and
wherein an input device or sensor ([0124]: “control modules”) is configured to acquire user input with regard to the augmented reality and/or the virtual reality ([0124]: “the display modules 202 are integrated with the control modules” and the control modules acquire user input, thus user input is acquired “with regard to the augmented reality and/or the virtual reality”).
Srinivasan further teaches that either touch-sensitive displays or virtual reality viewing devices can be used as displays and input devices/sensors with the predictable results of controlling a surgical robot system [0124].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walker such that the apparatus is configured to create the graphic display as augmented reality and/or virtual reality, wherein the display is configured to display the augmented reality and/or the virtual reality, and wherein the input device or sensor is configured to acquire the user input with regard to the augmented reality and/or the virtual reality, as taught by Srinivasan, because doing so so would be a simple substitution of one known element for another and would yield the predictable results of reliably accepting user inputs and providing visual feedback while a user controls a surgical robot system.
Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US 2017/0151027) in view of Ye et al. (US 2021/0196398).
In re claim 17, Walker discloses
wherein the geometrical and/or anatomical features in the dataset are identified by applying a function ([0095]: the “computer vision techniques” are considered a function under the broadest reasonable interpretation) to input data ([0095]: “imagery video from an imaging system” that is “frame grabbed by the system”),
wherein the input data is based on the dataset (the input data is from the imaging system and would be used by controller 34, i.e., it is based on the dataset),
Walker fails to explicitly disclose
wherein the geometrical and/or anatomical features in the dataset are identified by applying a trained function and
wherein at least one parameter of the trained function is based on a comparison between training features and comparison features.
Ye teaches systems and methods for robotic control of surgical instruments ([0013]; Figs. 1-2) and teaches
identifying geometric and/or anatomical features ([0008]: “identifying an anatomical feature in the second image,”; [0124]) by applying a trained function ([0008]: “using the pretrained neural network,”; Fig. 7; [0124-0132]: “transform/classification framework 720”) and
wherein at least one parameter of the trained function ([0126]: “adjust one or more parameters or weights associated [with the trained function]”) is based on a comparison between ([0124]: the at least one parameter is adjusted, i.e., based on, a comparison between 712 and 732; [0127])
training features (Fig. 7: known target labels 732) and
comparison features (Fig. 7: known anatomical images 712).
Ye further teaches that the comparison provides the predictable results of correctly identifying a target anatomical feature [0137].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walker such that the geometrical and/or anatomical features in the dataset are identified by applying a trained function and wherein at least one parameter of the trained function is based on a comparison between training features and comparison features, as taught by Ye, because doing so would require no inventive effort and would provide the predictable results of correctly identifying a target anatomical feature.
In re claim 18, the proposed combination yields (all mapping is directed to Walker unless otherwise stated) wherein the input data is additionally based on the positioning information ([0095]: the imagery video (i.e., the input data) is shown in Fig. 11B; fig. 11B: shows that the virtual instrument is located in the video, and locating the virtual instrument requires using the positioning information, therefore, the input data is considered to be “based on” the positioning information; [0072]).
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796 /DAVID HAMAOUI/SPE, Art Unit 3796
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