DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The Applicant filed Amendments to the Claims and Remarks on February 3, 2026 in response to the Examiner’s Non-Final Office Action, mailed November 3, 2025.
Amendments to the Claims
At this time, claims 1-9 and 11-21 are pending. Claims 1, 9, and 11 have been amended. Claim 10 has been cancelled. (Remarks, pg. 5)
Claim Rejections - 35 U.S.C. § 112(b)
Claim 11 was previously rejected under 35 U.S.C. 112(b) because the term “groves” lacked antecedent bases. (Remarks, pg. 5) Due to Amendments, Applicant’s arguments, see Remarks, pg. 5, with respect to claim 11 have been fully considered and are persuasive. The rejection of November 3, 2025 has been withdrawn.
Claim Rejections - 35 U.S.C. § 103
Claims 1 to 21 were previously rejected under 35 U.S.C. § 103 as being unpatentable over U.S. Publication No. 2021/0289189 to Sela ("Sela") in view of U.S. Publication No. 2020/0315432 to Tully et al. ("Tully"). Applicant’s arguments, see Remarks, pg. 5, with respect to the rejections of claims 1-21 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Sela in view of Flatt (cited below), in further view of Tully.
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.
Claims 1-4, 7-9, and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sela (US 2021/0289189) (cited previously) in view of Flatt (US 2019/0290379).
Regarding amended, independent claim 1, Sela discloses optical imaging system for imaging a target during a medical procedure. Sela further discloses a shell apparatus (housing of the optical imaging system 500 in Figs. 4A-4B) for a surgical imaging camera (camera 535 in Figs. 4A-4B), the shell apparatus comprising:
a top surface integrally formed with a front surface and two opposing side surfaces (Each of Figs. 5A-5E depict a different side and perspective view of the housing surrounding the optical imaging system.) defining empty space therebetween, each of the top surface, the side surfaces, and the front surface including at least three tracking features ([0073]: “The housing is provided with a frame on which trackable markers are mounted to enable tracking by a navigation system.”; [0053]: “In typical use with navigation systems, at least three markers 212 are provided on a tracked tool to define the tool in virtual space; however, four or more markers 212 can be used.”); and
a connector that is positioned within a centroid ([0038]; [0073]: “…the optical imaging system 500 comprises a support connector, such as a mechanical coupling, to enable removably coupling the optical imaging system 500 with the support structure.”).
Sela is silent to at least six kinematic constraints configured to form at least three kinematic constraint pairs that are located on an internally facing side of at least one of the top surface, the side surfaces, or the front surface, the at least three kinematic constraint pairs forming points of a triangle; and a connector that is positioned within a centroid of a triangle that is defined by the at least six kinematic constraints.
However, Flatt teaches a sterile barrier assembly, mounting system, and method for kinematically coupling first and second surgical components together through the sterile barrier assembly so that positioning is repeatable and deterministic. Flatt further teaches at least six kinematic constraints (first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 in Figs. 3-6) configured to form at least three kinematic constraint pairs ([0060]: “…a plurality of kinematic couplers (also referred to as kinematic elements) of the sterile barrier assembly 22 are used to kinematically couple the mounting portions 24, 26. In the embodiment shown, the kinematic couplers are spherical balls 28. During use, the balls 28 are seated in first and second pluralities of receptacles 30, 32, 34, 36, 38, 40 of the mounting portions 24, 26. The receptacles 30, 32, 34, 36, 38, 40 are sized and shaped to receive the balls 28.”) that are located on an internally facing side of at least one of the top surface, the side surfaces, or the front surface (mounting portions 24, 26 in Figs. 3-6), the at least three kinematic constraint pairs forming points of a triangle (see annotated Figs. 5-6 below showing that the first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 form points of a triangle, depicted by the dashed arrows.); and
a connector that is positioned within a centroid of a triangle (depicted by the dashed arrows in annotated Figs. 5-6) that is defined by the at least six kinematic constraints (load bar receiver 100 with load bar slot 104 in Fig. 5 connect with elongated slot 116 in Fig. 6).
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Flatt is analogous to the instant case in describing details of sterile barrier assembly that can hold or “sandwich” a surgical drape between two surfaces. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to kinematic constraints of Flatt in order to effectively secure the shell apparatus to the surgical imaging camera. Flatt additionally is concerned with minimizing movement between the two surfaces ([0059]: “Kinematic coupling exactly constrains the number of degrees of freedom that are to be constrained, i.e., no degree of freedom is overconstrained. For instance, in one embodiment there are six degrees of freedom between the mounting portions 24, 26, e.g., three translational and three rotational. Thus, kinematic coupling constrains exactly those six degrees of freedom.”).
Regarding claim 2, in view of the Sela/Flatt combination, Sela is silent to that the at least six kinematic constraints are located on an underside of the top surface.
However, Flatt teaches that the at least six kinematic constraints (first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 in Figs. 3-6) are located on an underside of the top surface (between mounting portions 24, 26 in Figs. 3-6).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to kinematic constraints of Flatt, located between the two connecting mounting portions, in order to effectively secure the shell apparatus to the surgical imaging camera.
Regarding claim 3, in view of the Sela/Flatt combination, Sela discloses that the connector is located at the top surface ([0038]; [0073]: “…the optical imaging system 500 comprises a support connector, such as a mechanical coupling, to enable removably coupling the optical imaging system 500 with the support structure.”).
Regarding claim 4, in view of the Sela/Flatt combination, Sela discloses that each of the top surface, the side surfaces, and the front surface is configured to cradle or at least partially cover a housing (housing of the optical imaging system 500 in Figs. 4A-4B) of the surgical imaging camera (camera 535 in Figs. 4A-4B) within the empty space ([0073]: “…referring to FIG. 4B… the primary camera 535, the optical assembly 505 (including the zoom optics 510 and focus optics 515), the controller 530, and the memory 550 are housed within a single housing of the optical imaging system 500.”).
Regarding claim 7, in view of the Sela/Flatt combination, Sela discloses that the connector is configured to engage a screw hole or receptor on the top surface of the surgical imaging camera ([0038]; [0073]: “…the optical imaging system 500 comprises a support connector, such as a mechanical coupling, to enable removably coupling the optical imaging system 500 with the support structure.”).
Regarding claim 8, in view of the Sela/Flatt combination, Sela discloses that the top surface, the side surfaces, and the front surface are configured to sandwich a surgical drape between the surgical imaging camera (camera 535 in Figs. 4A-4B) and the shell apparatus (housing of the optical imaging system 500 in Figs. 4A-4B).
Flatt further describes sandwich a surgical drape between two mounting portions (drape 62 of sterile barrier assembly 22 in Figs. 7 and 8). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Sela/Flatt combination in order to insert a surgical drape between the surgical imaging camera and the shell apparatus of the Sela/Flatt combination in order to maintain a sterile surgical environment during use of the instant invention.
Regarding amended, independent claim 9, Sela discloses shell apparatus (housing of the optical imaging system 500 in Figs. 4A-4B) for a surgical imaging camera (camera 535 in Figs. 4A-4B), the apparatus comprising:
a top surface integrally formed with a front surface and two opposing side surfaces (Each of Figs. 5A-5E depict a different side and perspective view of the housing surrounding the optical imaging system.) defining empty space therebetween, each of the top surface, the side surfaces, and the front surface including at least three tracking features ([0073]: “The housing is provided with a frame on which trackable markers are mounted to enable tracking by a navigation system.”; [0053]: “In typical use with navigation systems, at least three markers 212 are provided on a tracked tool to define the tool in virtual space; however, four or more markers 212 can be used.”).
Sela is silent to at least six kinematic constraints configured to form at least three kinematic constraint pairs that are located on at least one of the top surface, the side surfaces, or the front surface, the at least three kinematic constraint pairs forming points of a triangle for minimizing motion of the shell apparatus in an orthogonal direction relative to the triangle.
However, Flatt teaches at least six kinematic constraints (first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 in Figs. 3-6) configured to form at least three kinematic constraint pairs ([0060]: “…a plurality of kinematic couplers (also referred to as kinematic elements) of the sterile barrier assembly 22 are used to kinematically couple the mounting portions 24, 26. In the embodiment shown, the kinematic couplers are spherical balls 28. During use, the balls 28 are seated in first and second pluralities of receptacles 30, 32, 34, 36, 38, 40 of the mounting portions 24, 26. The receptacles 30, 32, 34, 36, 38, 40 are sized and shaped to receive the balls 28.”) that are located on at least one of the top surface, the side surfaces, or the front surface, the at least three kinematic constraint pairs forming points of a triangle (mounting portions 24, 26 in Figs. 3-6) for minimizing motion of the shell apparatus in an orthogonal direction relative to the triangle ([0059]: “Kinematic coupling exactly constrains the number of degrees of freedom that are to be constrained, i.e., no degree of freedom is overconstrained. For instance, in one embodiment there are six degrees of freedom between the mounting portions 24, 26, e.g., three translational and three rotational. Thus, kinematic coupling constrains exactly those six degrees of freedom.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to kinematic constraints of Flatt in order to effectively secure the shell apparatus to the surgical imaging camera. Flatt additionally is concerned with minimizing movement between the two surfaces ([0059]).
Regarding amended claim 11, in view of the Sela/Flatt combination, Sela discloses the surgical imaging camera (camera 535 in Figs. 4A-4B) and the shell apparatus (housing of the optical imaging system 500 in Figs. 4A-4B).
Sela is silent to that each of the at least six kinematic constraints is configured to mate or engage a magnetic object on a respective surface of the surgical imaging camera to create a magnetic coupling between the surgical imaging camera and the shell apparatus.
However, Flatt teaches that each of the at least six kinematic constraints (first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 in Figs. 3-6) is configured to mate or engage a magnetic object on a respective surface of the surgical imaging camera to create a magnetic coupling between the surgical imaging camera and the shell apparatus ([0183]: “One or more of the first plurality of receptacles and/or the second plurality of receptacles may comprise magnets to magnetically engage the balls in the receptacles. For instance, the first plurality of receptacles may comprise magnets to hold the balls to the first mounting portion until the second mounting portion is clamped to the first mounting portion. Similarly, the first mounting portion, having the contact surfaces of the receptacles integrated therein for kinematic coupling, could comprise magnets to hold the balls against the contact surfaces in the first mounting portion until the second mounting portion engages the first mounting portion.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to magnetic kinematic constraints of Flatt in order to effectively secure the shell apparatus to the surgical imaging camera.
Regarding claim 12, in view of the Sela/Flatt combination, Sela is silent to that the object includes at least one of a spherical object or semi-spherical object.
However, Flatt discloses various potential embodiments coupling mechanisms, including that the object includes at least one of a spherical object or semi-spherical object ([0060]: “In the embodiment shown, the kinematic couplers are spherical balls 28.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to spherical kinematic constraints of Flatt in order to effectively secure the shell apparatus to the surgical imaging camera.
Regarding claim 13, in view of the Sela/Flatt combination, Sela is silent to at least one magnetic connector configured to magnetically couple to a corresponding at least one magnetic connector on the surgical imaging camera (camera 535 in Figs. 4A-4B).
However, Flatt teaches at least one magnetic connector (first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 in Figs. 3-6) configured to magnetically couple to a corresponding at least one magnetic connector on the surgical imaging camera ([0183]: “One or more of the first plurality of receptacles and/or the second plurality of receptacles may comprise magnets to magnetically engage the balls in the receptacles. For instance, the first plurality of receptacles may comprise magnets to hold the balls to the first mounting portion until the second mounting portion is clamped to the first mounting portion. Similarly, the first mounting portion, having the contact surfaces of the receptacles integrated therein for kinematic coupling, could comprise magnets to hold the balls against the contact surfaces in the first mounting portion until the second mounting portion engages the first mounting portion.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to magnetic kinematic constraints of Flatt in order to effectively secure the shell apparatus to the surgical imaging camera.
Regarding claim 14, in view of the Sela/Flatt combination, Sela is not specific to the two opposing side surfaces each having a boot shape.
However, the particular shape of the two opposing side surfaces is of no patentable significance. The Examiner asserts that the boot shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed housing shape is significant. (See MPEP 2144.04.IV.B.)
Regarding claim 15, in view of the Sela/Flatt combination, Sela discloses that at least one of the top surface, the side surfaces, or the front surface includes at least one window for weight reduction or heat dissipation (Figs. 5A-5C (and further Figs. 5D-5E) depict windows on the exterior of augmented optical imaging system 600, highlighted within rectangles in the annotated figures below.; [0074]-[0075]: “The augmented optical imaging system 600 comprises one or more of the components of the optical imaging system 500.”).
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Regarding claim 16, in view of the Sela/Flatt combination, Sela is silent to that each of the at least six kinematic constraints are orientated at different angles with respect to each other.
However, Flatt teaches that each of the at least six kinematic constraints are orientated at different angles with respect to each other ([0182]: “The cone receptacles may be simplified by being replaced with three blocks having planar surfaces circumferentially equally spaced from one another and arranged at an angle approximating the cone angle. In this embodiment, the ball 28, 228, 428 seats within the three planar surfaces just like being seated in the cone, but contact is made at three contact points with the three planar surfaces.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include different angles of the kinematic constraints in order to further limit motion between the connecting surfaces.
Regarding claim 17, in view of the Sela/Flatt combination, Sela discloses that each of the top surface, the side surfaces, and the front surface includes protrusions ([0073]: “The housing is provided with a frame on which trackable markers are mounted to enable tracking by a navigation system.”) configured to accept or support a respective tracking feature (such as markers 212 in Fig. 2; [0054]-[0057]: “…fiducial markers 212 coupled with, such as placed on, or otherwise in fixed to, e.g., in rigid connection, any of the positioning system 208, the access port 12, the introducer 210, the tracked pointer 222, and/or other tracked instruments. …Still referring to FIG. 2, the active or passive fiducial markers 212 are coupled with, e.g., placed on, tools, such as the access port 12 and/or the optical imaging system 500, to be tracked, to determine the location and orientation of these tools using the tracking camera 213 and navigation system 205.”; [0073]).
Regarding claim 18, in view of the Sela/Flatt combination, Sela discloses that each of the protrusions extend orthogonally from the respective surface (such as markers 212 in Fig. 2; [0054]-[0057]: “…fiducial markers 212 coupled with, such as placed on, or otherwise in fixed to, e.g., in rigid connection… Still referring to FIG. 2, the active or passive fiducial markers 212 are coupled with, e.g., placed on, tools, such as the access port 12 and/or the optical imaging system 500, to be tracked, to determine the location and orientation of these tools using the tracking camera 213 and navigation system 205.”; [0073]: “The housing is provided with a frame on which trackable markers are mounted to enable tracking by a navigation system.”).
Regarding claim 19, in view of the Sela/Flatt combination, Sela discloses that each of the protrusions and the respective tracking feature has a circular shape or an oval shape ([0060]: “Printed markers may also be used as a calibration pattern, for example to provide distance information, e.g., 3D distance information, to an optical detector. Printed identification markers have configurations, such as concentric circles with different ring spacing and/or different types of bar codes, among other configurations.”).
Regarding claim 20, in view of the Sela/Flatt combination, Sela discloses that each of the tracking features includes at least one of a cross point, a fiducial, or a target (such as fiducial markers 212 in Fig. 2; [0054]-[0057]).
Regarding claim 21, in view of the Sela/Flatt combination, Sela discloses that each of the top surface, the side surfaces, and the front surface are constructed from plastic, carbon fiber, fiberglass, nylon, metal, or composites thereof ([0105]: “…various changes and modifications in form, material, work-piece, and fabrication material detail may be made, without departing from the spirit and scope of the present disclosure, as set forth in the appended claims, as may be apparent to those of ordinary skill in the art, are also encompassed by the present disclosure.”).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over the Sela/Flatt combination in further view of Tully et al. (US 2020/0315432, hereinafter referred to as Tully).
Regarding claim 5, in view of the Sela/Flatt combination, Sela is silent to that each of the at least six kinematic constraints is configured to mate or engage an object on a top surface of the surgical imaging camera.
However, Flatt teaches the at least six kinematic constraints (first plurality of receptacles 30, 32, 34 and second plurality of receptacles 36, 38, 40 in Figs. 3-6).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to kinematic constraints of Flatt, located between the two connecting mounting portions, in order to effectively secure the shell apparatus to the surgical imaging camera.
The Sela/Flatt combination is silent to that each of the at least six kinematic constraints is configured to mate or engage an object on a top surface of the surgical imaging camera.
However, Tully teaches systems and methods for medical imaging utilizing an optical adapter with a housing. Tully further teaches that each of the at least six kinematic constraints is configured to mate or engage an object on a top surface of the surgical imaging camera ([0079]; [0083]: “…the second end of the housing may be configured to releasably couple to the camera of the scope assembly using a quick release mechanism (e.g., snap-fit, latches, etc.).”).
Tully is analogous to the instant case in describing details of medical imaging and the constructional details of housings. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of the Sela/Flatt combination to include to kinematic constraints of Tully in order to effectively secure the shell apparatus to the surgical imaging camera.
Regarding claim 6, in view of the Sela/Flatt/Tully combination, Sela is silent to that the object includes at least one of a spherical object or semi-spherical object.
However, Flatt discloses various potential embodiments coupling mechanisms, including that the object includes at least one of a spherical object or semi-spherical object ([0060]: “In the embodiment shown, the kinematic couplers are spherical balls 28.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Sela to include to spherical kinematic constraints of Flatt in order to effectively secure the shell apparatus to the surgical imaging camera.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Orban, III et al. (US 2006/0161138); and
Kline et al. (US 2019/0076199).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796