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 26 May 2026 is acknowledged. Claims 1-19, 25, 26 are cancelled. Claims 29, 30, and 39 are currently amended. Claims 37, 38, and 39 are independent claims. Claims 20-24 and 27-39 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 May 2026 has been considered by the examiner. A signed copy is attached.
Objections/Rejections Withdrawn
The objection over claim 39 is withdrawn in light of Applicant’s amendment.
The rejection of claims 29 and 30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicant’s amendment.
The rejection of claims 22, 23, 27-36, and 39 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in view of Savall, US 20200237467 (30 Jul 2020) and further in view of Charles, US 20190254868 (22 August 2019), is withdrawn in light of Applicant’s amendments.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) (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(Last accessed 7/18/2025), is withdrawn in light of Applicant’s amendments.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 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 (Last accessed 17 July 2025) (26 pages, as attached), is withdrawn in light of Applicant’s amendments.
Response to Arguments
With regard to Applicant’s arguments Applicant’s arguments with respect to claims 37 and 38 (Remarks, pp. 11-14), Applicant apparently misconstrues the statements in the prior Office Action regarding the three rotary encoders. The prior Office Action mentioned nothing about the “benefits” of having or not having the three rotary encoders. The point that the prior (and current) Office Actions make is that the originally filed disclosure does not teach the criticality of the presence of three encoders. Applicant’s explanation in the Response filed 26 May 2026 is noted, as are the sections of the originally filed Specification pointed to in the response. However, the positive and negative implications of having more encoders are noted in the disclosure and known. There are always tradeoffs in any engineering endeavor. One encoder per degree of freedom is a standard in robotics, in general. Upon further review of the disclosure in light of Applicant’s remarks, it still does not appear that the criticality of having three encoders was disclosed, such that it could be determined that the specific number of them (e.g. three) would produce a new and unexpected result over the prior art.
The disclosure of a critical feature of the claimed invention is a legal test under US case law precedent, not an opinion or assessment about the claimed invention or the benefits thereof. Components of systems may have benefits that are the result of ordinary additive effects or tradeoffs and could even be synergistic (as strictly defined as being more than additive or more than the sum of the parts as a whole). Early identification of the criticality of components and a disclosure that those specific critical components would produce a new and unexpected effect over the prior art is the essence of criticality.
The concept that duplicative components have no patentable significance unless a new and unexpected result is produced, is not opinion or assessment about the claimed invention or its benefits, but is rather a long-standing legal test (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)). Evidence of criticality must be originally disclosed in the application (original Specification, original Claims, original Drawings, etc). That evidence is then analyzed within the context of examination, as assessed against the relevant prior art, to determine the sufficiency of the evidence to overcome the “mere duplication of parts” legal test established by In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). However, the original disclosure does not provide evidence of the criticality of having three encoders such that the number of encoders produces a new and unexpected result. Accordingly, claims 37 and 38, which are not commensurate in scope with the amended limitations of independent claim 39, remain rejected over Draelos et al., US 20190015167 (17 January 2019), in view of Savall, US 20200237467 (30 Jul 2020), for the reasons of record and the reasons set forth herein.
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 37 and 38 remain 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), for the reasons of record and the reasons set forth herein.
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 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.
Allowable Subject Matter
Claims 20-24, 27-36, and 39 are allowed.
Reasons for allowance:
Regarding independent claim 39 and the claims dependent thereof (claims 20-24 and 27-36), the closest prior art of Draelos et al., US 20190015167 (17 January 2019), Savall, US 20200237467 (30 Jul 2020) and Charles, US 20190254868 (22 August 2019) does not teach or reasonably suggest Applicant’s amendments to independent claim 39 wherein the method comprises “determining an identity of the ophthalmic tool that has been inserted into the patient’s eye; based on the identity of the identified ophthalmic tool, calculating a disposition of the remote center of motion location of the identified ophthalmic tool relative to the incision”.
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). However, Charles does not teach 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) and 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). However, Savall does not expressly teach calculating a disposition of the remote center of motion location of the ophthalmic tool relative to the incision, and based upon the identity of the ophthalmic tool.
Conclusion
Claims 20-24, 27-36, and 39 are allowed. Claims 37 and 38 remain rejected.
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 CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
