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 Amendment
The Amendment filed December 15th, 2025 has been entered. Claims 1 and 4 have been amended. Claims 1-14 are now pending in the application. The previous claim interpretation under 35 USC 112 (f) of claim 1 and the 35 USC 112 (b) rejection of claim 4 are withdrawn in light of Applicant's amendment. The previous drawings and specification objections are withdrawn in light of Applicant’s arguments.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
In regards to the 35 U.S.C. 112(b) rejection of claim 2, the applicant argues that claim 2, as amended, overcomes the rejection, however, claim 2 is not amended as of the most updated set of claims. The examiner asserts that the proposed amendment of “the controller is configured, when the distal end position of the surgical instrument changes from being outside the field of view of the endoscope to being within the field of view of the endoscope, to release the second operation mode that changes the operation of the surgical instrument that corresponds to the command received by the operating device” is exactly the same limitation as before, therefore, the rejection is maintained. The examiner reiterates that the limitation of “to release the second operation mode that changes the operation of the surgical instrument that corresponds to the command received by the operating device” is indefinite because claim 1 establishes the first operation mode as controlling the operation of the surgical instrument in response to the command received through the operating device, hence this function is directly associated with the first operation mode, which is why it is confusing when claim 2 attempts to establish the second operation mode as sharing this same function, without any prior context. The aspect of releasing the second operation mode once the surgical instrument changes from being outside the field of view of the endoscope to being within the field of view of the endoscope is understandable and clear. The examiner suggests amending claims 1 or 2 to clarify the intended functions of the first and second operation modes.
The applicant further argues that the rejections of claims 1-14 under 35 U.S.C. 102(a)(1) and 103 under Itkowitz et al. (US 20170165013 A1, hereinafter Itkowitz), taken alone, or in any combination, fails to disclose all of the elements recited in the claims as amended. The applicant suggests that Itkowitz does not explicitly disclose the second operation mode as claimed and that the office action does not prove that aspects disclosed in Itkowitz are sufficient to prove inherency.
The examiner makes the argument that any notion or mention of inherency in the office action is simply used as a figure of speech and not as the crux of the examiner’s rejections. The use of “it is inherent” and/ or “inherently” in the previous office action can simply be replaced with other terminology such as “i.e.” which aim to point out the obvious implications of the invention disclosed in Itkowitz and this is reflected in the rejections below; the second operation mode as claimed is being interpreted as a mode of a controller/ control device that becomes activated upon a surgical instrument being outside a field of view of an endoscope, that causes restriction of the surgical instrument and its operation. Itkowitz explicitly describes a state in which operation of an out-of-view surgical instrument is restricted in paragraph 48, [0048] “the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled,” directly disclosing technical/control influence on the surgical instrument. It is reasonable to interpret the state described by Itkowitz as the second operation mode as claimed since Itkowitz directly discloses the necessary functions and structure of the invention as claimed. Furthermore, the examiner asserts that Itkowitz discloses all of the elements of the claims as amended, described in the rejections below, and the examiner argues that Itkowitz discloses a second operation mode in which restricted operation is maintained while the surgical instrument is located outside the field of view of the endoscope since “maintained” can be interpreted in several ways and the examiner is interpreting this as the operation is kept in the restricted state while the surgical instrument is located outside the field of view of the endoscope, which is described by Itkowitz since the restricted operation is initiated and is kept that way while the surgical instrument is out-of-view until an acknowledgment is made by a clinician, as further described in the rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 2 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the surgical" in its first appearance. There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending the claim language to recite “the surgical instrument”
Claim 2 recites the limitation of “release the second operation mode that changes the operation of the surgical instrument that corresponds to the command received by the operating device” which is confusing and hard to understand, especially since the structure of the second operation mode defined in this limitation seems to be the same as that of the first operation mode defined in the claim language of claim 1.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 6, 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Itkowitz et al. (US 20170165013 A1, hereinafter Itkowitz).
Regarding Claim 1, Itkowitz discloses
A surgical system (teleoperational medical system 10; FIG. 1A) comprising:
a first manipulator (endoscopic imaging system 15; FIG. 1A) that supports an endoscope (imaging device 28; FIG. 1D);
a second manipulator (medical instrument system 14; FIG. 1A) that supports a surgical instrument (surgical tools 26; FIG. 1D);
an operating device (operator input system 16; FIG. 1B) comprising one or more of: handles; and pedals (par. 32 discloses control devices for operation input system consisting of a variety of input devices such as hand grips, hand-operated controllers, and actuatable handles),
the operating device configured to receive a command to operate the surgical instrument (par. 35 discloses operator input system receives signals, i.e. commands, to control the medical instrument); and
a controller (control system 20 + control devices disclosed in par. 32) including one or more processors (par. 34 discloses at least one processor) and configured to control operation of the surgical instrument in a first operation mode that controls the operation of the surgical instrument in response to the command received through the operating device (par. 35 discloses control system controls the operation of the medical instrument system),
wherein the controller is configured to determine, based on a relationship between a field of view of the endoscope (imaging instrument field of view 202; FIG. 3) and a position of a distal end of the surgical instrument, whether or not the distal end of the surgical instrument (distal instrument tip 210, 218; FIG. 4B) is located outside the field of view of the endoscope (par. 44 discloses determination of instruments inside or outside of the field of view),
when it is determined that the distal end of the surgical instrument is located inside the field of view of the endoscope, control the operation of the surgical instrument in the first operation mode (par. 48 discloses following mode in which the operator controls movement of the instruments; par. 32 discloses operator controls medical instrument system via control devices of the operator input system), and
when it is determined that the distal end of the surgical instrument is located outside the field of view of the endoscope, change the operation of the surgical instrument from the first operation mode to a second operation mode (par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation changes from the following mode to a restricted mode, i.e. second operation mode), and
the controller is configured, under the second operation mode, to change the operation of the surgical instrument by restricting the operation specified by the command (par. 35 discloses control system controls the operation of the medical instrument system; par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation changes from the following mode to a restricted mode, i.e. second operation mode, via the control system),
the restricted operation being maintained while the surgical is located outside the field of view of the endoscope (par. 48 discloses restricted mode is maintained when the surgical instrument is outside of the field of view until an acknowledgement is made by the clinician/ operator).
Regarding Claim 2,
The surgical system according to claim 1, wherein the controller is configured, when the distal end position of the surgical instrument changes from being outside the field of view of the endoscope to being within the field of view of the endoscope, to release the second operation mode that changes the operation of the surgical instrument that corresponds to the command received by the operating device (par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation changes from the following mode to a restricted mode, i.e. second operation mode, when acknowledgement of the indicators is not made, therefore the out of view indicators are tied to the restricted operation mode; FIGS. 4A-4F, par. 49 disclose that out of view indicators are only provided for instruments out of view, therefore, once instruments are within view, the restriction mode will be deactivated).
Regarding Claim 3,
The surgical system according to claim 1, wherein the command includes a movement command to move the surgical instrument, and the controller is configured, under the second operation mode, control the second manipulator not to move the surgical instrument regardless of the movement command (par. 35 discloses operator input system receives signals, i.e. commands, to move the medical instrument; par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the movement of the instrument is disabled despite movement commands until the acknowledgement of the indicator is made).
Regarding Claim 6,
The surgical system according to claim 1, wherein the surgical instrument includes jaws configured to open and close to each other, the command includes an opening/closing command to open or close the jaws, and the controller is configured, under the second operation mode, to control the jaws of the surgical instrument not to open or close the jaws of the surgical instrument regardless of the opening/closing command (par. 32 discloses control devices can close, i.e. as well as open, jaws of the medical instrument; par. 35 discloses the medical instruments of the system are controlled by signals, i.e. commands; par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the actuation of the jaws is disabled despite open/close commands until the acknowledgement of the indicator is made).
Regarding Claim 11,
The surgical system according to claim 1, further comprising
a display device configured to display an image captured by the endoscope (par. 38 discloses device which displays images captured by endoscope),
wherein the controller is configured, when it is determined that the distal end of the surgical instrument is located outside the field of view of the endoscope, to display a first indicator (visual indicator 244; FIG. 4B) that indicates the surgical instrument is located outside the field of view of the endoscope (par. 47 discloses out-of-view indicators that are visually presented; par. 44 discloses determination of instruments inside or outside of the field of view).
Regarding Claim 12,
The surgical system according to claim 11, wherein the controller is configured,
when it is determined that the distal end position of the surgical instrument is outside the field of view of the endoscope, to display a second indicator (textual information 246 + warning indicator 284; FIG. 4B, 4F) that prompts to pull back the endoscope toward a proximal end side of the endoscope so as to lead the distal end position of the surgical instrument to come in the field of view of the endoscope (par. 47 discloses textual information related to the out-of-view instrument may be provided identifying information and instructions to visualize the instrument, i.e. pull it back into field of view; par. 52 discloses warning indicator alerts user if instrument gets close to boundary of the field of view and when the instrument tips move a certain distance from the boundary, i.e. warning is to avoid going too far so that the operator can safely pull back).
Regarding Claim 13,
The surgical system according to claim 1, wherein the operating device is provided at the second manipulator (par. 32 discloses input devices are integral with the instruments of the medical instrument system, i.e. second manipulator).
Regarding Claim 14,
The surgical system according to claim 1, wherein the operating device (16) is provided independently from the first manipulator and the second manipulator (depicted in FIG. 1).
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) 4, 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itkowitz et al. (US 20170165013 A1, hereinafter Itkowitz) in view of Farlow (US 20200038125 A1).
Amended Claim 4:
The surgical system according to claim 1, wherein the command includes a movement command to move the surgical instrument,
the surgical instrument is set to move with a predetermined scaling amount in response to the movement command, and
the controller is configured, under the second operation mode, control the second manipulator to move the surgical instrument with a scaling amount that is smaller than the predetermined scaling amount in response to the movement command to move the surgical instrument.
Regarding Claim 4, Itkowitz discloses all of the elements of the current invention disclosed in claim 1, and, Itkowitz further discloses wherein the command includes a movement command to move the surgical instrument (par. 33 discloses motors that drive inputs on the medical instrument system, the motors moving in response to commands from the control system), the surgical instrument is set to move with a predetermined scaling in response to the movement command (par. 49 discloses in different embodiments the indicator can either be scaled as the surgical instrument moves, or remain the same as the indicator moves, i.e. a predetermined scaling between the indicator and instrument).
However, Itkowitz does not disclose a predetermined scaling amount, and the controller is configured, under the second operation mode, control the second manipulator to move the surgical instrument with a scaling amount that is smaller than the predetermined scaling amount in response to the movement command to move the surgical instrument.
Farlow teaches an analogous surgical system (robotic surgical system 1, FIG. 1) having linkages (12. i.e. manipulators) capable of comprising an end effector (20, i.e. surgical instrument) and an imaging device (16). Input handles (42, i.e. controller) have movement scaled to the movement of the linkages (12) within three-dimensional images which are scaled to be larger or smaller than the structures of a surgical site. Tools (20, i.e. surgical instruments) are moved within the surgical site, and are scaled with the input handles (42) and/or linkages, i.e. the movement of all of the working parts (input handles, linkages, tools) are scaled to set amounts in relation to one another so that during operation, there is consistency between the movement of the surgical instrument (20) and the three-dimensional image on a display (44), therefore, as the images are scaled to be smaller and larger, so is the movement of the surgical instrument [0032].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the surgical system of Itkowitz with the reduced scaling of Farlow in order to allow for surgical images to be more accurate and informative when depicting structures within the surgical site during operation/ providing a better view for the operator to understand the structures and their surroundings [0032].
Regarding Claim 7, Itkowitz discloses all of the elements of the current invention disclosed in claim 1, and Itkowitz further discloses
wherein in a state where the operation change mode is turned on (par. 48 discloses the initiation of a mode of the system),
the controller is configured to determine whether or not the distal end position of the surgical instrument is located outside the field of view of the endoscope, and configured (par. 44 discloses determination of instruments inside or outside of the field of view),
when it is determined that the distal end position of the surgical instrument is located outside the field of view of the endoscope, to change the operation of the surgical instrument from the first operation mode to the second operation mode that changes the operation of the surgical instrument that corresponds to the command (par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation changes from the following mode to a restricted mode, i.e. second operation mode).
However, Itkowitz does not disclose a mode setting device configured to set an operation change mode.
Farlow teaches an analogous surgical system (robotic surgical system 1, FIG. 1) having linkages (12. i.e. manipulators) capable of comprising an end effector (20, i.e. surgical instrument) and an imaging device (16). The system further including a processing unit (30, i.e. controller) which is in communication with a user console (40) to transmit control signals to the surgical robot (10, i.e. robot system 1) [0031]. Moreover, a graphical user interface (GUI, 100) on a display (44) depicts images captured from the camera of the robot system [0035] and includes a variety of indicators on the images such as an off-screen indicator (150) that alerts a user that an end effector is outside of the working area, as well as a mode indicator (166) which provides information relevant to a selected mode of the end effector [0041] by the user console (40; par. 34 discloses user console can control/ actuate various aspects of the surgical system, since par. 41 discloses that the modes of the end effector are selected, i.e. an aspect of the system is capable of selecting, i.e. most likely by the user console which controls the surgical system).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the surgical system of Itkowitz with the mode setting device of Farlow in order to provide a console which is capable of efficiently alternating between different modes of the system/ surgical instrument at the discretion of the user [0041-0043] or automatically based on the requirements of the system [0051].
Regarding Claim 8, Itkowitz, as previously modified by Farlow discloses all of the elements of the current invention disclosed in claim 7, and Itkowitz further discloses
wherein in a state where the operation change mode is turned off, the controller is configured, even when the distal end position of the surgical instrument is located outside the field of view of the endoscope, to not change from the first operation mode to the second operation mode, thereby to operate the surgical instrument according to the command without changing the operation of the surgical instrument that corresponds the command (par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation can be unrestricted outside of the field of view of the endoscope as long as acknowledgment is made).
However, Itkowitz does not disclose through the mode setting device.
Farlow further teaches the mode setting device (user console 40; par. 34 discloses user console can control/ actuate various aspects of the surgical system, par. 41 discloses that the modes of the end effector are selected, i.e. an aspect of the system is capable of selecting, i.e. most likely by the user console which controls the surgical system).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the surgical system of Itkowitz with the mode setting device of Farlow in order to provide a console which is capable of efficiently alternating between different modes of the system/ surgical instrument at the discretion of the user [0041-0043] or automatically based on the requirements of the system [0051].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itkowitz et al. (US 20170165013 A1, hereinafter Itkowitz) in view of Hares et al. (US 20220022982 A1, hereinafter Hares).
Regarding Claim 5, Itkowitz discloses all of the elements of the current invention disclosed in claim 1, however, Itkowitz does not disclose wherein the surgical instrument comprises an electrosurgical instrument configured to supply electrical energy to the distal end of the electrosurgical instrument, the command includes an energization command to supply the electrical energy, the controller is configured, under the second operation mode, to control the electrosurgical instrument not to supply the electrical energy regardless of the energizing command.
Hares teaches an analogous surgical system (typical surgical robot 100) consisting of an arm (102, par. 36 discloses at least two surgical robot arms, i.e. manipulators) which is attached to a surgical instrument (105). One of the least two arms comprises an endoscope while the other comprises an energized instrument, which can be an electrosurgical/ electrocautery instrument and is energized by an electrical current to perform a surgical function [0014-0015]. Moreover, the system further includes an assistance module (304, i.e. controller) which controls the operation of the energized instrument via sending control signals, including signals which prevent energization of the energized instrument [0019].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the surgical system of Itkowitz with the electrosurgical instrument of Itkowitz in order to provide a system in which the surgical instrument at the distal end can be provided with electrical energy to perform the surgical operations of cauterizing, cutting, etc. [0083] that also be prevented from receiving electrical energy when the system is in an unsafe state [0101].
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itkowitz et al. (US 20170165013 A1, hereinafter Itkowitz) in view of Hoffman et al. (US 20090248036 A1, hereinafter Hoffman).
Regarding Claim 9, Itkowitz discloses all of the elements of the current invention disclosed in claim 1, and Itkowitz further discloses
the controller is configured to determine whether or not the distal end position of the surgical instrument is located outside the field of view of the endoscope, and configured (par. 44 discloses determination of instruments inside or outside of the field of view),
when it is determined that the distal end position of the surgical instrument is located outside the field of view of the endoscope, to change the operation of the surgical instrument from the first operation mode to the second operation mode that changes the operation of the surgical instrument that corresponds to the command (par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation changes from the following mode to a restricted mode, i.e. second operation mode).
However, Itkowitz does not disclose further comprising a surgical site input device configured to input a surgical site, a state where a first surgical site is set through the surgical site input device.
Hoffman teaches an analogous surgical system (robotic surgery system 100) having one or more robotic arms (158, i.e. manipulators) which are attached to a robotic instrument (101) and/or an endoscopic camera (101B). An operator is able to view video images, of a surgical site including the robotic surgical tools that are in the field of view of the endoscopic camera, on a display device (164) [0047]. Moreover, the endoscope (101B) comprises a mechanical function (i.e. surgical input device) which allows it to switch between different positions at user discretion (i.e. user input) so that the observation window (fovea 650) of the display can be moved from a first area of the surgical site to a second area of the surgical site [0149-0150].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the surgical system of Itkowitz with the surgical site input device of Hoffman in order to capture a different high-definition spatial image to display pixels of a desired position [0150] which can potentially even be outside the display image [0149] which would be useful for locating surgical instruments outside the field of view of the endoscope.
Regarding Claim 10, Itkowitz, as previously modified by Hoffman discloses all of the elements of the current invention disclosed in claim 9, and Itkowitz further discloses
the controller is configured, even when the distal end position of the surgical instrument is outside the field of view of the endoscope, to not change the operation of the surgical instrument from the first operation mode to the second operation mode, thereby to operate the surgical instrument according to the command without changing the operation of the surgical instrument that corresponds to the command (par. 48 discloses the clinician must provide an acknowledgement that the instrument tip is outside of the field of view before operation of the out of view instrument is enabled, i.e. the operation can be unrestricted outside of the field of view of the endoscope as long as acknowledgment is made).
However, Itkowitz does not teach a second surgical site which is different from the first surgical site is set through the surgical site input device.
Hoffman further teaches a second surgical site (second fovea position 650B) which is different from the first surgical site is set through the surgical site input device (par. 149 discloses second area of surgical site, par. 150 discloses mechanical panning of endoscope to different positions).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the surgical system of Itkowitz with the surgical site input device of Hoffman in order to capture a different high-definition spatial image to display pixels of a desired position [0150] which can potentially even be outside the display image [0149] which would be useful for locating surgical instruments outside the field of view of the endoscope.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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