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 . In the event the determination of the status of the application as subject to 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.
Election/Restrictions
Applicant’s election, without traverse, of Group 1A, Group 2E, and Group 3Ii in the reply filed on 26 February 2026 is acknowledged. As this election was made without traverse, it is made FINAL.
Applicant states the species elected for examination are encompassed by claims 1-2, 5-7, 10-12, 15-17, and 20-23. Therefore, Claims 3-4, 8-9, 13-14, and 18-19 are presently withdrawn by the examiner for being directed to a non-elected species.
Domestic Benefit
Acknowledgment is made of applicant’s claim for domestic benefit to provisional application 63/416,149 filed 14 October 2022. The provisional application was reviewed by the examiner and is substantially similar to the claims, specification, and drawings of the instant application.
Information Disclosure Statement
Four Information disclosure statements (dated 18 October 2023, 29 June 2024, 24 March 2025, and 26 September 2025) have been considered by the examiner.
Claim Rejections - 35 USC § 102 / 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 1-2, 5, 10-12, 15, 17, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Pub. No. 2018/0263714 (Kostrzewski et al., hereinafter, Kostrzewski).
Regarding Claim 1, Kostrzewski teaches A force sensor unit (see at least [0168], [0244], and FIG. 7D: drill with force sensor 604; “it is to be understood that the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations”; “In certain embodiments, this is accomplished with a force sensor that comprises a plurality of force sensing units”), comprising:
a beam at least partially surrounded by a hard stop structure (see at least FIG. 7D: drill bit 602 surrounded by body 610 including force sensor 604);
a first strain sensor coupled to the beam (see at least [0147]-[0148] and FIG. 7A: strain gauge 706 integrated into drill bit 602); and
a second strain sensor (see at least FIG. 7D: force sensor 604);
wherein the beam includes a proximal end portion and a distal end portion (see at least FIG. 7D: the motor 608 is at the proximal end);
wherein the hard stop structure includes a reference location at which the distal end portion of the beam contacts the hard stop structure on a condition in which a deflection of the beam is larger than a beam deflection threshold (see at least [0148] and FIG. 7D: drill bit 602 will slightly bend into force sensor 604);
wherein the first strain sensor generates a first signal associated with the deflection of the beam (see at least [0147]: strain gauges generate signals from deflection; “strain gauge 706 integrated directly into the shaft of the drill bit 602”); and
wherein the second strain sensor produces a second signal in response to contact between the reference location and the distal end portion of the beam (see at least [0148]: “As shown in FIG. 7D, the shaft of the drill bit 602, in some implementations, includes a flexible element 708 that allows the drill bit 602 to bend (e.g., only slightly) such that after deflection of the shaft of the drill bit 602, forces can be measured by the force sensor 604”).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to combine the strain gauge 706 of figure FIG. 7B of Kostrzewski with the force sensor 604 external to the beam and flexible element 708 of FIG. 7D of Kostrzewski with the motivation of accurately detecting contact / force on the tip of the tool in more conditions including with robustness to spinning (for the location in FIG. 7D) and with deflections not large enough to deform the beam into the sensor (for the location in FIG. 7B) (see at least [0146]). As part of this combination, one of ordinary skill in the art would determine the applied force based on the signals from both sensors.
Regarding Claim 2, Kostrzewski teaches the limitations of Claim 1. Furthermore, Kostrzewski discloses wherein: the hard stop structure is any of a shroud or an outer shaft and surrounds at least a portion of the beam; and the second strain sensor is positioned on the hard stop structure (see at least FIG. 7D: body 610 with force sensor 604 surrounding the drill bit 602 is at least an outer shaft).
Regarding Claim 5, Kostrzewski teaches the limitations of Claim 2. Furthermore, Kostrzewski discloses wherein: the hard stop structure is the outer shaft; the outer shaft further includes a wall surrounding any of the beam and a portion of the shroud; the wall includes an inner face; and the second strain sensor is coupled to the inner face of the wall at the reference location (see at least FIG. 7D: body 610 (the outer shaft) includes a wall surrounding the beam; the force sensor 604 is either directly or indirectly coupled to the inner face of the body 610; Examiner notes that “any of the beam and a portion of the shroud” has been interpreted to include at least the following definitions “the beam and/or a portion of the shroud” or “both a portion of the shroud and any of the beam” because, as written, “any of” could be “any of the beam” or “any of” the list; as there are a finite number of possibilities, this has not been rejected under 35 U.S.C. 112(b)).
Regarding Claim 10, Kostrzewski teaches the limitations of Claim 1 and the entire rejection for Claim 1 is incorporated to this rejection of Claim 10. Furthermore, Kostrzewski teaches A surgical system (see at least [0123] and FIG. 1), comprising:
a manipulator unit (see at least FIG. 1: surgical robot 102);
a medical instrument supported by and operated by the manipulator unit and including a force sensor unit (see at least [0032] and FIG. 7D: “a robotic arm with an end-effector having an instrument attached thereto; a force sensor attached directly or indirectly to the robotic arm”);
an input device (see at least [0158]); and
a controller operably coupling the input device and the manipulator unit, operatively coupling the force sensor unit and the input device, and including a logic system and a memory system (see at least FIG. 37 and FIG. 38);
wherein the force sensor unit includes a beam, a first strain sensor, and a second strain sensor; wherein the beam includes a proximal end portion and a distal end portion; wherein the first strain sensor is positioned to produce a first signal associated with a deflection of the beam; wherein a hard stop structure at least partially surrounds the beam; wherein the hard stop structure includes a reference location at which the distal end portion of the beam contacts the hard stop structure on a condition in which a deflection of the beam is larger than a beam deflection threshold (see rejection for Claim 1); and
wherein the controller includes a haptic feedback module (see at least [0192]-[0195] and FIG. 50: “In certain embodiments, a robotic surgical system provides haptic feedback when a surgeon attempts to move the surgical instrument outside of the operational volume. In this way, the surgeon feels resistance when the surgical instrument is at the boundary of the operational volume and can redirect the surgical tool away from the boundary”), and
the controller is configured to perform a plurality of operations including:
receiving a first signal from the first strain sensor, the first signal being associated with a strain associated with the deflection of the beam in response to an applied force (see rejection for Claim 1),
receiving a second signal from the second strain sensor, the second signal being produced in response to contact at the distal end portion of the beam and the reference location (see rejection for Claim 1),
determining, via the controller and based at least in part on the first signal and at least in part on the second signal, a determined magnitude of the applied force (see at least [0023], [0134], [0168], and FIG. 44: “a force feedback subsystem (e.g., including sensor(s), actuator(s), controller(s), servo(s), and/or other mechanisms) for delivering a haptic force to a user manipulating the end effector (e.g., manipulating a surgical instrument inserted in the instrument holder of the end effector) (e.g., wherein the force feedback subsystem includes one or more sensors for performing one or more of (I) to (IV) as follows: (I) detecting a resistive force caused by the surgical instrument contacting, moving against, penetrating, and/or moving within a tissue of the patient, (II) distinguishing between contacted tissue types (e.g., determining when contacted tissue meets or exceeds a threshold resistance, e.g., when the tissue is bone), (III) detecting a force delivered by the operator (e.g., the surgeon, e.g., delivered by direct manipulation of the surgical instrument inserted in the surgical instrument holder of the end effector) (e.g., to cause movement of the surgical instrument and, therefore, the end effector), and (IV) distinguishing between the force delivered by the operator and the resistive force caused by movement of the surgical instrument in relation to the tissue of the patient”; “(IV) distinguish between the force delivered by the operator and the resistive force caused by movement of the surgical instrument in relation to the tissue of the patient”; “As the operative moves the position of the end effector, the position of the end effector is dynamically determined (e.g., by processor 3812). Specifically, in some implementations, the system dynamically determines a 3D position of one or more points of a surgical instrument. Forces received by the surgical instrument are dynamically determined when the surgical instrument contacts, moves against, penetrates, and/or moves within the patient. The system can measure these forces and distinguish between contacted tissue types. This can be accomplished, for example, by determining when contacted tissue meets or exceeds a threshold resistance, such as when the tissue is bone). The system can further detect forces applied to the surgical instrument by the operator and distinguish between forces delivered by the operator and the resistive force caused by movement of the surgical instrument in relation to the tissue of the patient”; “A force sensor attached to the robotic arm can be used to measure the force applied by a surgeon relative to the force exerted by the material in order for the processor to determine when contact is made to the material (e.g., by determining mechanical properties). In certain embodiments, this is accomplished with a force sensor that comprises a plurality of force sensing units (e.g., one sensing unit to measure feedback from the surgical instrument and a separate sensing unit force applied by the surgeon)”; combining force measurements from a plurality of force sensing units to make determinations of the amount of force applied is taught), and
providing, via the haptic feedback module and based on the determined magnitude of the applied force, haptic feedback to a human operator of the input device (see at least [0023] and [0131]: “This allows the operator to both apply forces to the system as well as feel resistance (e.g., via haptic feedback) as a surgical instrument contacts tissue in the patient”).
Regarding Claim 11, Kostrzewski teaches the limitations of Claim 10. Furthermore, Kostrzewski teaches wherein: the second signal is indicative of whether the distal end portion of the beam is in contact with the hard stop structure at the reference location (see at least [0148]: “after deflection of the shaft of the drill bit 602, forces can be measured by the force sensor 604”; the deflection is into the force sensor 604);
on a condition in which the distal end portion of the beam is not in contact with the hard stop at the reference location, the haptic feedback is a designed haptic feedback (see at least [0023], [0041], and [0192]: “(vii) dynamically determine a force feedback to deliver via the force feedback subsystem (e.g., to an operator of the robotic arm during the surgical procedure) based at least in part on the re-registered patient position [(e.g., based at least on the updated 3D representation of the patient situation and a current position of the end effector (and/or the surgical instrument) (e.g., subject to predetermined go/no-go zones) (e.g., thereby permitting, facilitating, directing (e.g., imposing a haptic detent or well), inhibiting (e.g., imposing a speed constraint), and/or disallowing movement of the surgical instrument in go/no-go zones, e.g., by direct manipulation of the surgical instrument by the operator, e.g., surgeon)”; “In certain embodiments, a robotic surgical system provides haptic feedback when a surgeon attempts to move the surgical instrument outside of the operational volume. In this way, the surgeon feels resistance when the surgical instrument is at the boundary of the operational volume and can redirect the surgical tool away from the boundary”; haptic feedback due to moving within the operational volume, one of ordinary skill in the art would understand this this occurs regardless of contacting the bone / force on the sensors); and
on a condition in which the distal end portion of the beam is in contact with the hard stop at the reference location, the haptic feedback is a modified haptic feedback (see at least [0023] and [0131]: “This allows the operator to both apply forces to the system as well as feel resistance (e.g., via haptic feedback) as a surgical instrument contacts tissue in the patient”; resistance to the operator based on tissue contact which is determined from the force sensors).
Regarding Claim 12, Kostrzewski teaches the limitations of Claim 11. Furthermore, Kostrzewski teaches providing, via the controller, an indication to the operator of the input device that the modified haptic feedback is provided to, or is available to be provided to, the input device (see at least [0131]: “This allows the operator to both apply forces to the system as well as feel resistance (e.g., via haptic feedback) as a surgical instrument contacts tissue in the patient”; the resistance is the modified haptic feedback (i.e., not the boundary resistance, which is the designed haptic feedback) and is an indication to the operator).
Regarding Claim 15, Kostrzewski teaches the limitations of Claim 11. Furthermore, Kostrzewski teaches the second signal corresponds to a reactive force magnitude that is larger than a reactive-force minimum threshold (see at least [0015] and [0023]-[0024]: “In certain embodiments, a threshold (e.g., a magnitude of haptic feedback) must be exceeded in order to register the contact as belonging to the patient's anatomy. Furthermore, in this way, the magnitude of haptic feedback can be used to determine the type of tissue being contacted (e.g., because bone is harder than soft tissue)”; “(iii) a force feedback subsystem (e.g., including sensor(s), actuator(s), controller(s), servo(s), and/or other mechanisms) for delivering a haptic force to a user manipulating the end effector (e.g., manipulating a surgical instrument inserted in the instrument holder of the end effector) (e.g., wherein the force feedback subsystem includes one or more sensors for performing one or more of (I) to (IV) as follows: (I) detecting a resistive force caused by the surgical instrument contacting, moving against, penetrating, and/or moving within a tissue of the patient, (II) distinguishing between contacted tissue types (e.g., determining when contacted tissue meets or exceeds a threshold resistance, e.g., when the tissue is bone), (III) detecting a force delivered by the operator (e.g., the surgeon, e.g., delivered by direct manipulation of the surgical instrument inserted in the surgical instrument holder of the end effector) (e.g., to cause movement of the surgical instrument and, therefore, the end effector), and (IV) distinguishing between the force delivered by the operator and the resistive force caused by movement of the surgical instrument in relation to the tissue of the patient”).
Regarding Claim 17, this claim is substantially similar to Claim 2, and rejected for the same reasons as Claim 2.
Regarding Claim 20, this claim is substantially similar to Claim 5, and rejected for the same reasons as Claim 5.
Claims 6-7 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski in view of U.S. Patent No. 4,982,611 (Lorenz and Van Dr Riet, hereinafter, Lorenz).
Regarding Claim 6, Kostrzewski teaches the limitations of Claim 5. Furthermore, Kostrzewski suggests but does not appear to explicitly teach wherein: the second strain sensor includes at least one force sensor operably coupled to a load ring; and the load ring is a deformable member (see at least [0148] and FIG. 7D: in FIG. 7D, a section of the force sensor is shown which implies to one of ordinary skill in the art that it is a ring, one of ordinary skill in the art would consider that the load ring would be some amount deformable).
Lorenz, in the same field of robotics, and therefore analogous art, explicitly teaches force sensors distributed around a circumference and embedded into the deformable body (see at least column 2 and FIG. 1: “The elements of the preferred sensor tip 10 include an elastomeric body 12 and four transducers 14, 16, 18, and 20”).
Therefore, at least one force sensor operably coupled to a load ring; and the load ring is a deformable member would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, because one of ordinary skill in the art would have looked for a specific solution for the force sensor 604 of Kostrzewski and substituted four force sensors embedded in an elastomeric body of Lorenz with the motivation of using a known technique that measures force from multiple directions / so that the a force will be registered from deformation in the left, right, front, or back direction.
Regarding Claim 7, the Kostrzewski and Lorenz combination teaches the limitations of Claim 6. Furthermore, Lorenz teaches four sensors distributed around a cross-section circumference in an elastomeric member (see at least FIG. 3: transducers 14, 16, 18, and 20, elastomeric body 12). Therefore, wherein: the deformable member is an elastomeric member; the second strain sensor includes three or more force sensors embedded in the elastomeric member; and the three or more force sensors are distributed equidistantly about a cross-sectional circumference of the outer shaft would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, for the same reasons / with the same motivation as Claim 6.
Regarding Claim 21, this claim is substantially similar to Claim 6, and rejected for the same reasons as Claim 6.
Regarding Claim 22, this claim is substantially similar to Claim 7, and rejected for the same reasons as Claim 7.
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski in view of U.S. Pub. No. 2013/0296886 (Green and Jensen, hereinafter, Green).
Regarding Claim 23, Kostrzewski teaches the limitations of Claim 10. Furthermore, Kostrzewski teaches wherein: the surgical system includes a surgical instrument shaft; the proximal end portion of the beam is coupled to the surgical instrument shaft (see at least [0127], [0144], and FIG. 7D: the motor 608 is and/or leads to the surgical instrument shaft).
Kostrzewski does not explicitly teach the structure of the tools other than the drill (i.e., the surgical system includes…a surgical instrument wrist assembly; the distal end portion of the beam is coupled to the surgical instrument wrist assembly).
Green, in the same field of robots for surgery, and therefore analogous art, teaches the surgical system includes…a surgical instrument wrist assembly; the distal end portion of the beam is coupled to the surgical instrument wrist assembly (see at least [0027], FIG. 1, and FIG. 2A: there is a wrist on the distal end of instrument 14 between shaft 100 and jaws 122, 124).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art to substitute the instrument with a wrist between a beam and pair of jaws of Green into Kostrzewski because Kostrzewski provided the drill as one exemplary embodiment and envisioned application to other surgical instruments (see at least Kostrzewski [0144]).
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: Kostrzewski, the closest prior art, does not disclose, teach, suggest, nor render obvious wherein: the second signal corresponds to a reactive force magnitude that is larger than a reactive-force maximal threshold; on a condition when the reactive force magnitude is larger than the reactive-force maximal threshold, the plurality of operations include halting an operation of the surgical system; and the modified haptic feedback corresponds to the halted state of the surgical system in combination with the limitations of Claims 1 and 11, and there is not another reference that could be combined with Kostrzewski, without impermissible hindsight, to reject these limitations as obvious under 35 U.S.C. 103.
Additional Relevant Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure and may be found on the accompanying PTO-892 Notice of References Cited:
U.S. Pub. No. 2018/0021058 which teaches combining information from sensors on a port with information from sensors in an end-effector and providing feedback to an user.
U.S. Pub. No. 2018/0113038 which teaches combining sensor measurements from multiple sensors on an instrument.
Conclusion
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/A.R.M./Examiner, Art Unit 3658
/JASON HOLLOWAY/Primary Examiner, Art Unit 3658
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