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 .
Formal Matters
Applicant’s Response and Amendments filed 10/23/2025 is acknowledged. Claims 1-19, 25, 26 are cancelled. Claims 20-24, 27-32, and 35 are currently amended. New claims 37-39 are added. Dependencies have been altered such that the previously examined claims now depend from directly or indirectly from new claim 39. New claims 37 and 38 are also independent claims.
Priority/Benefit
The ADS filed 1 May 2023 actually contains incorrect continuity type data. An annotated image is provided below so that Applicant may file a corrected ADS and remedy the matter at the earliest possible time. The application claims benefit as a Continuation of US PCT/IB2022/061636 (1 December 2022) which is proper. PCT/IB2022/061636 claims benefit of 63/285,218 (2 December 2021), which is proper. However, PCT/IB2022/061636 is not a proper Continuation of US Provisional 63/406,881. The ADS should be corrected such that PCT/IB2022/061636 may show a claim of benefit to both US Provisional applications, but not a claim of benefit to one and as a Continuation of the other. See MPEP 211.01b, as provided in detail in the prior Office Action mailed 23 July 2025 at numbered page 2 (Priority/Benefit section).
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Information Disclosure Statement
The information disclosure statements (IDS) submitted on 23 October 2025 and 31 October 2025 have been considered by the examiner. Signed copies are attached.
Objections/Rejections Withdrawn
The objection to the first paragraph of the Specification is withdrawn in light of Applicant’s amendments.
The rejection of claims 19, 25, 27-31, and 35 under 35 U.S.C. 102(a)(1) as being anticipated by Draelos et al., US 20170015167 (17 January 2019), is withdrawn in light of Applicant’s amendments.
The rejection of claim 20 under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20190015167 (17 January 2019), as set forth above, and further in view of Rozum Robotics, “How to Select the Best Motor for a Jointed Arm Robot” Robotics Tomorrow, published online 21 October 2021 (9 pages total) (https://www.roboticstomorrow.com/article/2021/10/how-to-select-the-best-motor-for-a-jointed-arm-robot/17618) (Last accessed 7/18/2025), is withdrawn in light of Applicant’s amendments.
The rejection of claims 21 and 22 under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20170015167 (17 January 2019), as set forth above, in view of Mitros et al., "Optic Nerve Sheath Fenestration With a Multi-Arm Continuum Robot," in IEEE Robotics and Automation Letters, vol. 5, no. 3, pp. 4874-4881, July 2020, doi: 10.1109/LRA.2020.3005129. (Last accessed 17 July 2025) (26 pages, as attached), is withdrawn in light of Applicant’s amendments.
The rejection of claims 32-34, and 36 under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20170015167 (17 January 2019), is withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claims 20-24, 27-36 have been considered. However, a further search and consideration is always required in response to each submission by Applicant. The combination of the claims caused a shift in the search strategy, which identified relevant prior art that should be applied to the claims. In light of the extensive amendments and the new claims, which encompass combinatorial subject matter from prior claims, as well as the additional search and further consideration, the examiner has reconsidered the prior indication of allowable subject matter. Accordingly the prior indication of allowable subject matter is WITHDRAWN. New rejections are set forth below. In light of these considerations, this Office Action is NON-FINAL.
Claim Objections
Claims 39 is objected to for having a period at the end of line 26, which is not at the end of the claim.
Claim Rejections - 35 USC § 112(b)
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 29 and 30 are 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.
Regarding claims 29 and 30, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 22, 23, 27-36, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20190015167 (17 January 2019), in view of Savall, US 20200237467 (30 Jul 2020) and further in view of Charles, US 20190254868 (22 August 2019).
Examiner’s Note: claims 37-39 are independent claims. Claims 20-24 and 27-36 are all directly or indirectly dependent on claim 39. Accordingly, independent claim 39 will be addressed out of numerical claim order herein for the purpose of readability. Independent claims 37 and 38, which have no dependent claims at present, will be presented in their regular order.
Regarding independent claim 39, Draelos teaches a method (¶8) for performing a procedure on an eye of a patient using an ophthalmic tool (FIG 16B, 1606) that has a tip (DALK needle 1608, ¶149; ¶153) the method comprising:
driving a robotic unit (FIGs 16A; ¶¶148-149) to insert the ophthalmic tool (1606) into the patient's eye via an incision in a cornea of the patient's eye (¶153), such that a tip (1608) of the ophthalmic tool (1606) is disposed within the patient's eye (¶151);
determining the location and the orientation of the tip of a control-component tool (tool, ¶¶58-60, 160, 163) that is configured to be moved by an operator (¶160), based upon data received from one or more location sensors that are disposed on a control-component arm (1604) of a control component (FIG 17; ¶¶46, 146, MIOCT), the control-component arm (1604) being coupled to the control-component tool (¶¶159, 160);
moving the tip (1608) of the ophthalmic tool (1606) within the patient's eye in a manner that corresponds with movement of the control-component tool (tool, ¶¶58-60, 160, 163); and
providing force feedback (¶129) to the operator via (¶147) the control-component arm (1604), wherein the control component arm (1604) includes a plurality of links (FIG 16A) that are coupled to each other via arm joints (FIG 16A) and one or more motors (¶147) that are operatively coupled to respective arm joints (¶147) and the force feedback (¶129) is provided to the operator by driving the control-component arm (1604) using the plurality of motors (¶¶147, 152),
wherein: driving the robotic unit (FIG 16A; 1604) to insert the ophthalmic tool (1606) into the patient's eye via the incision in the cornea of the patient's eye (¶153) comprises driving the robotic unit (FIG 16A; 1604) to insert the ophthalmic tool (1608) into the patient's eye via the incision in the cornea of the patient's eye (¶153), such that the tip of the ophthalmic tool (1608, ¶149) is disposed within the patient's eye (¶153) and a remote center of motion location of the ophthalmic tool (1606) is disposed within the incision (¶147); and
providing force feedback (¶129) to the operator via the control-component arm (1604) comprises providing force feedback (¶129) to the operator that is indicative of a disposition of the remote center of motion (¶147) location of the ophthalmic tool relative to the incision[.] (¶147).
Draelos does not teach the method further comprising: determining an identity of the ophthalmic tool that has been inserted into the patient's eye, and based upon the identity of the ophthalmic tool, calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision.
Charles teaches surgical instruments for determining one or more parameters associated with ocular surgery, including determining an identity of the ophthalmic tool that has been inserted into the patient's eye (FIG 3B, ¶34). Charles also provides a basis for differentiating reflective markings and different methods of determining different types of tools based on tool surface material, finish, color, markers, radiopacity, and different levels of detected reflected light (¶18).
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63).
Draelos, Charles, and Savall all teach in the field of robotic surgical system components and the use thereof. Draelos and Charles teach specific robotic components and methods related to ophthalmic tools and ocular surgery. Although, Draelos discloses the claimed base method (using a robotic system to perform a procedure on an eye of a patient using an ophthalmic tool that has a tip shaft in a controlled manner with feedback). Draelos does not teach the method further comprising: determining an identity of the ophthalmic tool that has been inserted into the patient's eye, and based upon the identity of the ophthalmic tool, calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision.
Charles specifically addresses surgical instruments for determining one or more parameters associated with ocular surgery, including determining an identity of the ophthalmic tool that has been inserted into the patient's eye (FIG 3B, ¶34). Charles teaches that tool markings may be reflective or more reflective than other surfaces (¶18). Because Draelos includes image-guided robotic systems in ocular surgery and teaches that the system provides the capability to control multiple physical tools from one haptic input device (¶44) and also teaches that the needle is hyperreflective (¶166) one of ordinary skill in the art seeking to control multiple tools would reasonably consult Charles’ marker identification solution. Charles marker solutions in an ocular surgery setting can be incorporated into Draelos’ base device and methods of use using known assembly methods without redesigning the base device or substantially altering their methods of use.
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). This permits calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision. Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Draelos expressly teaches that a robot’s control system can derive the surgeon’s desired tool motion from the measured forces subject to any virtual fixes in effect, such as a remote center of motion. A person of ordinary skill in the art attempting to render Draelos’ optical surgery method robot-compatible encompassing remote center of motion would look for established connector and articulation tools and sensors that are modular and can be adapted to the RCM requirements of the system of devices used in Draelos’ method in order to enable robotic actuation.
Because the references address the same engineering problem (using markers and sensors to refine end-point control of surgical tools in robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a marker identification component and sensor encoder to the existing robotic DALK surgical system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
A ”control-component arm” is interpreted under the broadest reasonable interpretation standard. The specification states that “[t]he terms “joystick” and “control-component arm” are used interchangeably in the present disclosure.” The specification refers to element 30 as the joystick in FIGs 6A-C.
A “control-component tool” is interpreted under the broadest reasonable interpretation standard. The specification defines a “control-component tool” as element 32 in FIGs 6A-C and 7.
Regarding claim 23, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches the tip of the control-component tool (tool, ¶¶58-60, 160, 163).
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63).
Savall teaches and an inertial measurement unit (tracking sensor 214; ¶32) comprising at least one of sensor selected from the group consisting of: a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit being configured to generate inertial- measurement-unit data indicative of an orientation of the tip of control-component tool (¶32).
None of Draelos, Savall or Charles expressly teaches three rotary encoders, each of the three rotary encoders coupled to a respective one of the arm joints.
There is no teaching in the instant disclosure as to the criticality of exactly three rotary encoders or where each of the three rotary encoders are coupled to a respective one of the arm joints. The selection of the number and type of encoders for any particular use is dependent on the use (Savall: ¶62) and there is nothing of record to suggest that “three rotary encoders coupled to respective arm joints” would produce new and unexpected results over the robotic arm functionality taught by Savall. Applicant is reminded that In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Regarding claim 24, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein the control-component tool (tool, ¶¶58-60, 160, 163); is coupled to the control-component arm (1604) via three tool joints (FIG 16A).
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Savall teaches rotary-encoder data indicative of an XYZ location of the tip of the control-component tool (¶55, rotation, pitch, yaw; ¶62 rotation, roll, and yaw).
Savall teaches and an inertial measurement unit (tracking sensor 214; ¶32) comprising at least one of sensor selected from the group consisting of: a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit being configured to generate inertial- measurement-unit data indicative of an orientation of the tip of control-component tool (¶32).
None of Draelos, Savall or Charles expressly teaches two rotary encoders coupled to each one of the arm joints and one rotary encoder coupled to each one of the tool joints and configured to detect movement of the tool joint and to generate rotary-encoder data indicative of an orientation of the tip of the control-component tool, in response thereto.
There is no teaching in the instant disclosure as to the criticality of exactly two rotary encoders coupled to each one of the arm joints; and one rotary encoder coupled to each one of the tool joints. The selection of the number and type of encoders for any particular use is dependent on the use (Savall: ¶62) and there is nothing of record to suggest that “two rotary encoders coupled to respective arm joints” and “one rotary encoder coupled to each one of the tool joints” would produce new and unexpected results over the robotic arm functionality taught by Savall. Applicant is reminded that In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Regarding claim 27, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein providing force feedback (¶129) to the operator (¶147) via the control-component arm (1604) comprises:
performing velocity measurements (¶147) on the control-component tool (tool, ¶¶58-60, 160, 163),
calculating a force to be applied to the operator based on the velocity measurements (¶147), and
driving the control-component arm (1604) to apply the calculated force to the operator (¶¶147, 151, 152).
Regarding claim 28, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein providing force feedback (¶129) to the operator via the control-component arm (1604) comprises: performing measurements of a position (¶¶147, 148) of the ophthalmic tool (1606) relative to the incision (¶156), calculating a force to be applied to the operator based on the position measurements (¶148), and driving the control-component arm (1604) to apply the calculated force to the operator (¶¶147, 151, 152).
Savall also teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Savall teaches rotary-encoder data indicative of an XYZ location of the tip of the control-component tool (¶55, rotation, pitch, yaw; ¶62 rotation, roll, and yaw).
Regarding claim 29, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein providing force feedback (¶129) to the operator via the control-component arm (1604) comprises calculating a force to be applied to the operator (¶150) such as to be equal and opposite to a force applied to the control-component tool (tool, ¶¶58-60, 160, 163) by the operator (¶¶150, 152), and driving the control-component arm (1604) to apply the calculated force to the operator (¶151).
Regarding claim 30, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches providing force feedback (¶129) to the operator via the control-component arm (1604) comprises calculating a force to be applied to the operator (¶150) such as to be proportional to a distance (¶¶146, 150-152, 169) of an outer edge of the ophthalmic tool (1606) from a center of the incision (¶150), and driving the control-component arm (1604) to apply the calculated force to the operator (¶151).
Regarding claim 31, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches further comprising receiving an input (¶147) from the operator (¶150) that is indicative of a stiffness of force feedback (¶129) that they wish to receive (¶147),
wherein providing force feedback (¶129) to the operator (¶150) via the control-component arm (1604) comprises calculating a force to be applied to the operator at least partially based upon the input from the operator and driving the control-component arm (1604) to apply the calculated force to the operator (¶147).
Regarding claim 32, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein providing force feedback (¶129) to the operator (¶150) via the control-component arm (1604) comprises constraining movement (¶¶153-155) of the control-component tool (tool, ¶¶58-60, 160, 163) in a manner that corresponds to how movement of the remote center of motion location of the ophthalmic tool (1606) relative to the incision should be constrained (¶147).
The phrase “manner” in which it “should be constrained” is also a results-effective variable which is influenced by individualized factors such as the surgery to be performed, the unique patient needs, and the unique set of circumstances of the patient. In so far as the method taught by Draelos, it is capable of performing in a “manner” consistent with the disclosed parameters of how movement of the remote center of motion location of the ophthalmic tool relative to the incision should be constrained. As such, the manner of selection of the constrains to be implemented would amount to nothing more than routine experimentation of the methods taught by Draelos that can be optimized on an individual use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 33, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein constraining movement (¶¶153-155) of the control-component tool (tool, ¶¶58-60, 160, 163) comprises constraining movement (¶¶153-155) of the control-component tool (tool, ¶¶58-60, 160, 163) in a manner that constrains (¶¶153-155) the remote center of motion location of the ophthalmic tool (1606) to remain within an incision zone that is larger than the incision (¶147).
The “manner” in which it “should be constrained” is also a results-effective variable which is influenced by individualized factors such as the surgery to be performed, the unique patient needs, and the unique set of circumstances of the patient. In so far as the method taught by Draelos, it is capable of performing in a “manner” consistent with the disclosed parameters of how movement of the remote center of motion location of the ophthalmic tool relative to the incision should be constrained. As such, the manner of selection of the constrains to be implemented would amount to nothing more than routine experimentation of the methods taught by Draelos that can be optimized on an individual use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 34, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein constraining movement (¶¶153-155) of the control-component tool (tool, ¶¶58-60, 160, 163) comprises constraining movement (¶¶153-155) of the control- component tool (tool, ¶¶58-60, 160, 163) in a manner that constrains (¶¶153-155) the remote center of motion location of the ophthalmic tool (1606) to remain within the incision (¶147).
The “manner” in which it “constrains” is also a results-effective variable which is influenced by individualized factors such as the surgery to be performed, the unique patient needs, and the unique set of circumstances of the patient. In so far as the method taught by Draelos, it is capable of performing in a “manner” consistent with the disclosed parameters of how movement of the remote center of motion location of the ophthalmic tool relative to the incision should be constrained. As such, the manner of selection of the constrains to be implemented would amount to nothing more than routine experimentation of the methods taught by Draelos that can be optimized on an individual use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 35, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein providing force feedback (¶129) to the operator via the control-component arm (1604) comprises calculating a force function that is based on a distance (¶146) of an outer edge of the ophthalmic tool (1606) from a center of the incision in two directions (¶147), wherein providing force feedback (¶129) to the operator (¶150) via the control-component arm (1604) comprises driving the control-component arm (1604) to apply force to the operator (¶147) based on the calculated force function (¶¶153-155).
Regarding claim 36, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos teaches wherein a first one of the two directions (¶153) is parallel to the incision and at a tangent to the cornea of the patient's eye at the incision (¶153), and a second one of the two directions is normal to the first direction and at a tangent to the cornea of the patient's eye at the incision (¶¶154-155).
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20190015167 (17 January 2019), in view of Savall, US 20200237467 (30 Jul 2020).
Regarding independent claim 37, Draelos teaches a method (¶8) for performing a procedure on an eye of a patient using an ophthalmic tool (FIG 16B, 1606) that has a tip (DALK needle 1608, ¶149; ¶153) the method comprising:
driving a robotic unit (FIGs 16A; ¶¶148-149) to insert the ophthalmic tool (1606) into the patient's eye via an incision in a cornea of the patient's eye (¶153), such that a tip (1608) of the ophthalmic tool (1606) is disposed within the patient's eye (¶151);
determining the location and the orientation of the tip of a control-component tool (tool, ¶¶58-60, 160, 163) that is configured to be moved by an operator (¶160), based upon data received from one or more location sensors that are disposed on a control-component arm (1604) of a control component (FIG 17; ¶¶46, 146, MIOCT), the control-component arm (1604) being coupled to the control-component tool (¶¶159, 160);
moving the tip (1608) of the ophthalmic tool (1606) within the patient's eye in a manner that corresponds with movement of the control-component tool (tool, ¶¶58-60, 160, 163); and
providing force feedback (¶129) to the operator via (¶147) the control-component arm (1604), wherein the control component arm (1604) includes a plurality of links (FIG 16A) that are coupled to each other via arm joints (FIG 16A) and one or more motors (¶147) that are operatively coupled to respective arm joints (¶147) and the force feedback (¶129) is provided to the operator by driving the control-component arm (1604) using the plurality of motors (¶¶147, 152),
Draelos does not teach wherein the one or more location sensors include: three rotary encoders, each of the three rotary encoders coupled to a respective one of the arm joints and configured to detect movement of the respective arm joint and to generate rotary-encoder data indicative of an XYZ location of the tip of the control-component tool in response thereto; and
an inertial measurement unit comprising at least one of sensor selected from the group consisting of: a three-axis accelerometer, a three-axis gyroscope, and a three-axis
magnetometer, the inertial measurement unit being configured to generate inertial- measurement-unit data indicative of an orientation of the tip of control-component tool.
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63).
Savall teaches and an inertial measurement unit (tracking sensor 214; ¶32) comprising at least one of sensor selected from the group consisting of: a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit being configured to generate inertial- measurement-unit data indicative of an orientation of the tip of control-component tool (¶32).
Draelos and Savall all teach in the field of robotic surgical system components and the use thereof. Although, Draelos discloses the claimed base method (using a robotic system to perform a procedure on an eye of a patient using an ophthalmic tool that has a tip shaft in a controlled manner with feedback). Draelos does not teach the method further comprising: determining an identity of the ophthalmic tool that has been inserted into the patient's eye, and based upon the identity of the ophthalmic tool, calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision.
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). This permits calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision. Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Draelos expressly teaches that a robot’s control system can derive the surgeon’s desired tool motion from the measured forces subject to any virtual fixes in effect, such as a remote center of motion. A person of ordinary skill in the art attempting to render Draelos’ optical surgery method robot-compatible encompassing remote center of motion would look for established connector and articulation tools and sensors that are modular and can be adapted to the RCM requirements of the system of devices used in Draelos’ method in order to enable robotic actuation.
Because the references address the same engineering problem (using markers and sensors to refine end-point control of surgical tools in robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a marker identification component and sensor encoder to the existing robotic DALK surgical system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
There is no teaching in the instant disclosure as to the criticality of exactly three rotary encoders or where each of the three rotary encoders are coupled to a respective one of the arm joints. The selection of the number and type of encoders for any particular use is dependent on the use (Savall: ¶62) and there is nothing of record to suggest that “three rotary encoders coupled to respective arm joints” would produce new and unexpected results over the robotic arm functionality taught by Savall. Applicant is reminded that In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
A ”control-component arm” is interpreted under the broadest reasonable interpretation standard. The specification states that “[t]he terms “joystick” and “control-component arm” are used interchangeably in the present disclosure.” The specification refers to element 30 as the joystick in FIGs 6A-C.
A “control-component tool” is interpreted under the broadest reasonable interpretation standard. The specification defines a “control-component tool” as element 32 in FIGs 6A-C and 7.
Regarding independent claim 38, Draelos teaches a method (¶8) for performing a procedure on an eye of a patient using an ophthalmic tool (FIG 16B, 1606) that has a tip (DALK needle 1608, ¶149; ¶153) the method comprising:
driving a robotic unit (FIGs 16A; ¶¶148-149) to insert the ophthalmic tool (1606) into the patient's eye via an incision in a cornea of the patient's eye (¶153), such that a tip (1608) of the ophthalmic tool (1606) is disposed within the patient's eye (¶151);
determining the location and the orientation of the tip of a control-component tool (tool, ¶¶58-60, 160, 163) that is configured to be moved by an operator (¶160), based upon data received from one or more location sensors that are disposed on a control-component arm (1604) of a control component (FIG 17; ¶¶46, 146, MIOCT), the control-component arm (1604) being coupled to the control-component tool (¶¶159, 160);
moving the tip (1608) of the ophthalmic tool (1606) within the patient's eye in a manner that corresponds with movement of the control-component tool (tool, ¶¶58-60, 160, 163); and
providing force feedback (¶129) to the operator via (¶147) the control-component arm (1604), wherein the control component arm (1604) includes a plurality of links (FIG 16A) that are coupled to each other via arm joints (FIG 16A) and one or more motors (¶147) that are operatively coupled to respective arm joints (¶147) and the force feedback (¶129) is provided to the operator by driving the control-component arm (1604) using the plurality of motors (¶¶147, 152), wherein the control-component tool (tool, ¶¶58-60, 160, 163); is coupled to the control-component arm (1604) via three tool joints (FIG 16A).
Draelos does not expressly teach wherein the one or more location sensors include:
two rotary encoders coupled to each one of the arm joints and configured to detect movement of the arm joint and to generate rotary-encoder data indicative of an XYZ location of the tip of the control-component tool, in response thereto; and one rotary encoder coupled to each one of the tool joints and configured to detect movement of the tool joint and to generate rotary-encoder data indicative of an orientation of the tip of the control-component tool, in response thereto;
an inertial measurement unit comprising at least one of sensor selected from the group consisting of: a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit being configured to generate inertial- measurement-unit data indicative of an orientation of the tip of control-component tool.
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Savall teaches rotary-encoder data indicative of an XYZ location of the tip of the control-component tool (¶55, rotation, pitch, yaw; ¶62 rotation, roll, and yaw).
Savall teaches and an inertial measurement unit (tracking sensor 214; ¶32) comprising at least one of sensor selected from the group consisting of: a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit being configured to generate inertial-measurement-unit data indicative of an orientation of the tip of control-component tool (¶32).
Neither Draelos nor Savall expressly teaches two rotary encoders coupled to each one of the arm joints and one rotary encoder coupled to each one of the tool joints and configured to detect movement of the tool joint and to generate rotary-encoder data indicative of an orientation of the tip of the control-component tool, in response thereto.
There is no teaching in the instant disclosure as to the criticality of exactly two rotary encoders coupled to each one of the arm joints; and one rotary encoder coupled to each one of the tool joints. The selection of the number and type of encoders for any particular use is dependent on the use (Savall: ¶62) and there is nothing of record to suggest that “two rotary encoders coupled to respective arm joints” and “one rotary encoder coupled to each one of the tool joints” would produce new and unexpected results over the robotic arm functionality taught by Savall. Applicant is reminded that In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Draelos and Savall all teach in the field of robotic surgical system components and the use thereof. Although, Draelos discloses the claimed base method (using a robotic system to perform a procedure on an eye of a patient using an ophthalmic tool that has a tip shaft in a controlled manner with feedback). Draelos does not teach the method further comprising: determining an identity of the ophthalmic tool that has been inserted into the patient's eye, and based upon the identity of the ophthalmic tool, calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision.
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). This permits calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision. Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Draelos expressly teaches that a robot’s control system can derive the surgeon’s desired tool motion from the measured forces subject to any virtual fixes in effect, such as a remote center of motion. A person of ordinary skill in the art attempting to render Draelos’ optical surgery method robot-compatible encompassing remote center of motion would look for established connector and articulation tools and sensors that are modular and can be adapted to the RCM requirements of the system of devices used in Draelos’ method in order to enable robotic actuation.
Because the references address the same engineering problem (using markers and sensors to refine end-point control of surgical tools in robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a marker identification component and sensor encoder to the existing robotic DALK surgical system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
A ”control-component arm” is interpreted under the broadest reasonable interpretation standard. The specification states that “[t]he terms “joystick” and “control-component arm” are used interchangeably in the present disclosure.” The specification refers to element 30 as the joystick in FIGs 6A-C.
A “control-component tool” is interpreted under the broadest reasonable interpretation standard. The specification defines a “control-component tool” as element 32 in FIGs 6A-C and 7.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20190015167 (17 January 2019) (previously cited of record), in view of Savall, US 20200237467 (30 Jul 2020), further in view of Charles, US 20190254868 (22 August 2019) as set forth above, and further in view of Rozum Robotics, “How to Select the Best Motor for a Jointed Arm Robot” Robotics Tomorrow, published online 21 October 2021 (9 pages total) (https://www.roboticstomorrow.com/article/2021/10/how-to-select-the-best-motor-for-a-jointed-arm-robot/17618) (Last accessed 7/18/2025) (previously cited of record).
Regarding claim 20, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos modified by Savall and Charles does not expressly teach wherein the control component includes exactly three motors operatively coupled to respective arm joints.
However, Draelos teaches robotic arm 1604 comprising three joints (FIG 16A). Draelos also teaches that a robotic tool may be moveable by any suitable robot as will be understood by those of skill in the art (¶59). Additionally, Draelos teaches that “an admittance controller can produce a robot end-effector velocity (v, ω) which the robot's internal joint position controller tracks with feedback (q) using joint motor techniques” (¶147) and teaches “[t]o complement fine force sensing using the end-effector's force sensor, control systems and methods disclosed herein can estimate robot joint forces with motor drive currents to detect manipulation of the robot at points other than its end-effector” (¶152).
Rozum Robotics teaches methods of determining the selection of motors to power a robot with a robotic joint (pp. 2-3). Rozum Robotics teaches that the type of robotic joints, the application need of linear, orthogonal, dynamic rotational, twisting or revolving joints, or combinations thereof will determine the types of motions and the related nuances of their requirements will impact the selection of the types and numbers of motors (p. 3). The tolerability of the device and use-case for noise and the amount or degree of noise, the degree of precision required, and the amount of torque at various speeds are other considerations that are routinely considered (p. 3).
Draelos, Charles, Savall and Rozum Robotics all teach in the field of robotic surgical system components and the use thereof. Draelos modified by Savall and Charles does not expressly teach wherein the control component includes exactly three motors operatively coupled to respective arm joints. Rozum Robotics teaches that there is a recognized need in the art to provide robotic arms with motors suited to the particular functionality of the use-case for which the robot is used. Draelos expressly teaches a robotic arm comprising three joints (FIG 16A). Although Draelos is silent as to the number of motors that the robotic arm contains, a person of ordinary skill in the art would reasonably understand that it is common for at least one motor to be coupled to each of the respective joints.
Rozum Robotics demonstrates that the selection of motors is a results-effective variable which can be optimized. One of ordinary skill in the art would clearly recognize that the number and type of motors must be sufficient to operate the robotic arm as desired and is dependent on the type of joints, the degree of noise tolerability, the degree of precision required, and how much torque is necessary for the robotic unit to perform its function. As such, the selection of the number of motors coupled to respective arm joints would amount to nothing more than routine experimentation that can be optimized on an individual use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Additionally, there is no teaching in the instant disclosure as to the criticality of “exactly three motors” coupled to respective arm joints. Applicant is reminded that In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The selection of the number and type of motors for any particular use is dependent on the use and there is nothing of record to suggest that “exactly three motors operatively coupled to respective arm joints” would produce new and unexpected results over the robotic arm functionality taught by Draelos.
The recitation of “wherein a control component comprises exactly three motors operatively coupled to respective arm joints” is broadly interpreted as one motor coupled to each of three respective arm joints, comprising a total of three motors, with one motor driving one joint.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Draelos et al., US 20190015167 (17 January 2019) (previously cited of record), in view of Savall, US 20200237467 (30 Jul 2020), further in view of Charles, US 20190254868 (22 August 2019) as set forth above, and further in view of Mitros et al., "Optic Nerve Sheath Fenestration With a Multi-Arm Continuum Robot," in IEEE Robotics and Automation Letters, vol. 5, no. 3, pp. 4874-4881, July 2020, doi: 10.1109/LRA.2020.3005129. (Last accessed 17 July 2025) (26 pages, as attached) (previously cited of record).
Regarding claim 21, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos does not teach wherein the control-component arm includes a belt, and at least one of the motors is operatively coupled to a corresponding one of the arm joints via the belt, such that the at least one of the motors is disposed closer to a base of the control-component unit than if the at least one of the motors directly drove the corresponding one of the arm joints.
Mitros teaches a multi-arm continuum robot for ophthalmic operations (optic nerve sheath fenestration (ONSF)) (Abstract). Mitros teaches wherein the control-component arm includes a belt, and at least one of the motors is operatively coupled to a corresponding one of the arm joints via the belt (p. 6, II. B. Motion Transmission Mechanism, ¶2: “[a] timing belt is used for each rotational DoF”), such that the at least one of the motors is disposed closer to a base of the control-component unit than if the at least one of the motors directly drove the corresponding one of the arm joints (FIG 3; p. 6, B. Motion Transmission Mechanism, ¶2).
Draelos, Savall, Charles, and Mitros all teach in the field of robotic surgical system components and the use thereof. Draelos and Charles teach specific robotic components and methods related to ophthalmic tools and ocular surgery. Although, Draelos discloses the claimed base method (using a robotic system to perform a procedure on an eye of a patient using an ophthalmic tool that has a tip shaft in a controlled manner with feedback). Draelos does not teach the method wherein the control-component arm includes a belt, and at least one of the motors is operatively coupled to a corresponding one of the arm joints via the belt, such that the at least one of the motors is disposed closer to a base of the control-component unit than if the at least one of the motors directly drove the corresponding one of the arm joints.
Charles specifically addresses surgical instruments for determining one or more parameters associated with ocular surgery, including determining an identity of the ophthalmic tool that has been inserted into the patient's eye (FIG 3B, ¶34). Charles teaches that tool markings may be reflective or more reflective than other surfaces (¶18). Because Draelos includes image-guided robotic systems in ocular surgery and teaches that the system provides the capability to control multiple physical tools from one haptic input device (¶44) and also teaches that the needle is hyperreflective (¶166) one of ordinary skill in the art seeking to control multiple tools would reasonably consult Charles’ marker identification solution. Charles marker solutions in an ocular surgery setting can be incorporated into Draelos’ base device and methods of use using known assembly methods without redesigning the base device or substantially altering their methods of use.
Savall teaches the use of sensor encoders to detect relative position of components to determine pose (¶62). Savall teaches that encoders can be used to determine the overall orientation of the support structure a linkage and a relative position and orientation of center of rotation and that relative position can be determined through kinematics of the linkage system as described by the encoder information (¶62). This permits calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision. Savall also teaches that the position and orientation information derived from the encoders can be combined with other tracking information to determine an overall spatial state (¶63). Draelos expressly teaches that a robot’s control system can derive the surgeon’s desired tool motion from the measured forces subject to any virtual fixes in effect, such as a remote center of motion. A person of ordinary skill in the art attempting to render Draelos’ optical surgery method robot-compatible encompassing remote center of motion would look for established connector and articulation tools and sensors that are modular and can be adapted to the RCM requirements of the system of devices used in Draelos’ method in order to enable robotic actuation.
Mitros teaches that there is a recognized need in the art to include a design need or market pressure to provide robotic arms with motors suited to the particular functionality of the use-case for which the robot is used. This is similar to the teachings of Savall regarding motors attached to joints at ¶65. Savall teaches that motors can be used to avoid singularities within the mechanism (¶65). Singularities occur when robotic manipulators lose the abilities to control certain movements due to the alignment of joints, leading to a reduction in its degrees of freedom (¶65). The teaching and suggestion of Mitros of using timing belts for each rotational degree of freedom (DoF) would provide more control, precision, and could overcome the problem of singularities in joints. The teachings of both Savall and Mitros demonstrate a finite number of identified predictable potential solutions to the structure of robotics which are readily adaptable for precision robotic control in limited spaces, such as ophthalmic DALK settings as discussed by Draelos (micrometer-scale precision, ¶163).
Because the references address the same engineering problem (using markers, sensors/encoders/motor timing belts to refine end-point control of surgical tools in robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (facilitating marker identification, promoting sensor encoding, and engaging enhanced motor precision to limit singularities to the existing robotic DALK surgical system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 22, Draelos modified by Savall and Charles teaches the method according to claim 39, as set forth above.
Draelos suggests, but does not expressly teach, wherein a majority of the one or more motors directly drive a corresponding one of the arm joints to which they are operatively coupled (¶¶147, 152).
Mitros teaches devices and methods for performing procedures on patients using robotic ophthalmic tools (Abstract). Mitros teaches “[e]very translational DoF is actuated by a continuous RS motor with a maximum torque of 1.47 Nm while servo motors with maximum torque of 3.43 Nm and range from 0° — 270° are selected for the rotational DoFs” (FIG 3; p. 6, B. Motion Transmission Mechanism, ¶2).
Draelos and Mitros teach in the same field of endeavor, surgical robotic systems. Draelos teaches feedback control using joint motor techniques to control the motors (¶147) and estimates robot joint forces with motor drive currents to detect manipulation of the robot at points other than its end-effector (¶152). Mitros expressly teaches motors actuated for each translational and rotational degree of freedom (DoF) within the arm joint. The teachings of both Draelos and Mitros demonstrate a finite number of identified predictable potential solutions to the structure of robotics which are readily adaptable for precision robotic control in limited spaces, such as ophthalmic DALK settings as discussed by Draelos (¶163).
Because the references address the same engineering problem (using motors in robotic arm joints which provide for refined control of robots other than at their end-point) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (facilitating motor-driven robotic joint movement based on applicable degrees of freedom), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed. This Office Action is NON-FINAL.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771