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 .
Information Disclosure Statement
Information Disclosure Statements (IDS)s submitted on 03/20/2024, 05/16/2024, 11/21/2024, and 01/17/2025 have been entered and fully considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soto et al. (U.S. Publication No. 2023/0397961) hereinafter “Soto.
Regarding claim 15, Soto discloses a surgical kit [surgical kit 200 of FIG. 4] comprising:
a surgical component, [component 206; see FIG. 4] including:
a component body [ section 203 and 207 is the component body; see FIG. 4]; and
a connector socket; [socket of FIG. 7A and [0137]; the socket is a part of the component 206 of FIG. 4] wherein the connector socket comprises:
a coupling socket [coupling socket 308; see FIG. 7A and [0137]] configured to receive a coupling stud when the coupling socket moves along a first direction relative to the coupling stud; [see [0137]; the arm interface 212 (i.e. the coupling stud) is inserted into the socket 308 of connector socket of FIG. 7A]
a partial collar structure; [the second end 307 and the walls w1 and w2 make up the exterior surface which makes the partial collar structure; see FIG. 7A and [0137]] and
a release mechanism hinged to the component body with a movable terminal edge in a distal relationship to the hinge; [clamp handle 312; see FIG. 8a-b and [0141]]
wherein the release mechanism is configured to oppose a biasing force that is directed opposite the first direction; [see [0142]; the clamp handle and jaw 312-314 secure the coupling stud (tracker interface 206)]
wherein the partial collar structure is configured to engage a narrow neck portion of a distally-positioned locking stud adjacent a tapered head portion on the locking stud when the coupling stud is received in the coupling socket in the first direction and the movable terminal edge of the release mechanism is adjacent a surface of the tapered head portion; [see FIG. 13C; the coupling stud 308 is received in the narrow neck portion and it is adjacent to the release mechanism 312]
and wherein an application of a release force on the release mechanism opposite the biasing force releases the engagement of the partial collar structure with the narrow neck portion and causes the coupling socket to move opposite the first direction. [see [0155]-[0156]; the release of the latch allows the stud 308 to be removed; see FIG. 13B-C ]
Regarding claim 18, Soto further discloses that the coupling stud exhibits a cylindrical shape. [see FIG. 4 of Soto; the coupling stud 208 is cylindrical in shape]
Regarding claim 19, Soto further discloses that the release mechanism is a button release. [the release switch 226 may be a button; see [0184] and FIG. 4 of Soto]
Regarding claim 20, Soto further discloses that the movable terminal edge is between the hinge and the coupling socket. [see FIG. 4 of Soto]
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Soto et al. (U.S. Publication No. 2023/0397961) hereinafter “Soto” in view of Dumpe et al. (WO 2021/127,161) hereinafter “Dumpe” and Rybnikov et al. (WO 2025/153,975) hereinafter “Rybnikov”.
Regarding claim 1, Soto discloses a surgical kit [surgical kit of Dumpe; see FIG. 12] comprising:
a first component [component 200; see FIG. 4 of Soto] including:
a handgrip portion; [element 214 can be held in hand]
a connector; [end portion 212 is the connector] wherein the first component exhibits a component axis enclosed by the handgrip portion [see FIG. 4; the axis first component is along the longitudinal axis of the element 214] and the connector is situated at a terminal portion of the component axis; [see FIG. 4; element 212 is located at the distal termination of the longitudinal axis of element 902]
Soto does not expressly disclose that the connector comprises: a distally positioned locking stud with a tapered head portion; and an array of coupling studs between the locking stud and the handgrip portion; wherein the locking stud further exhibits a narrow neck portion between the tapered head portion and the array of coupling studs, the narrow neck portion being adjacent the tapered head portion, the locking stud further exhibiting an axis of symmetry along its length, the axis of symmetry being aligned with the component axis; wherein the array of coupling studs comprise four coupling studs situated such that two of the four coupling studs share a first axis of symmetry along their length, and another two of the four coupling studs share a second axis of symmetry along their length, the first axis of symmetry forming a right angle with the second axis of symmetry, and the four coupling studs extending radially outward from a point where the first axis of symmetry intersects the second axis of symmetry; and wherein the first axis of symmetry and the second axis of symmetry define a plane such that the component axis forms a right angle to the plane
Dumpe, directed towards a connector to a surgical tool [see abstract of Dumpe] further discloses wherein the connector comprises:
a distally positioned locking stud with a tapered head portion; [element 514B is the equivalent to the locking stud as they engage the bone and lock the connector to the bone; see FIG. 8; and [0176]]; it includes a tapered end] and
an array of coupling studs between the locking stud and the handgrip portion; [see FIG. 8, guide shafts 506 A-B-C are used to receive and couple to shafts; see [0172]]
wherein the locking stud further exhibits a narrow neck portion between the tapered head portion and the array of coupling studs, [see FIG. 8; there is a narrow neck immediately distal to the tapered portion of element 514B] the narrow neck portion being adjacent the tapered head portion,[see FIG. 8] the locking stud further exhibiting an axis of symmetry along its length, the axis of symmetry being aligned with the component axis [the axis of symmetry of the element 514B is along the longitudinal axis of the element 902];
Rybnikov, directed towards a connectable surgical tool [see abstract of Rybnikov] further disclose wherein the array of coupling elements [alignment sockets 6012 are used for connection and act equivalent to the coupling studs as they are used for coupling; see FIG. 52 and [0426]; the examiner notes that Dumpe has already disclosed use of coupling studs and Rybnikov is merely used to show the orientation of an array of coupling elemetns] comprise four coupling elements situated such that two of the four coupling studs share a first axis of symmetry along their length, [see Fig. 52] and another two of the four coupling elements share a second axis of symmetry along their length, the first axis of symmetry forming a right angle with the second axis of symmetry, and the four coupling elements extending radially outward from a point where the first axis of symmetry intersects the second axis of symmetry;[see FIG. 52] and wherein the first axis of symmetry and the second axis of symmetry define a plane such that the component axis forms a right angle to the plane. [see [0162] discloses that the sockets have 90 degree angular orientation with respect to each other, therefore they have two axis of symmetry which are perpendicular to each other]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the connector of Soto such that the connector comprises: a distally positioned locking stud with a tapered head portion; and an array of coupling studs between the locking stud and the handgrip portion; wherein the locking stud further exhibits a narrow neck portion between the tapered head portion and the array of coupling studs, the narrow neck portion being adjacent the tapered head portion, the locking stud further exhibiting an axis of symmetry along its length, the axis of symmetry being aligned with the component axis according to the teachings of Dumpe in order to allow for coupling in more locations depending on the need. Further, doing so would have been substituting a type of connector element with another equivalent connector with improved and predictable results and would have been obvious to try to a person of ordinary skill in the art. (KSR Rationale B)
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the array of coupling studs of Soto as modified by Dumpe such that the array of coupling studs comprise four coupling studs situated such that two of the four coupling studs share a first axis of symmetry along their length, and another two of the four coupling studs share a second axis of symmetry along their length, the first axis of symmetry forming a right angle with the second axis of symmetry, and the four coupling studs extending radially outward from a point where the first axis of symmetry intersects the second axis of symmetry; and wherein the first axis of symmetry and the second axis of symmetry define a plane such that the component axis forms a right angle to the plane according to the teachings of Rybnikov in order to allow for the coupling elements to be equally spaced and [see [0162] of Rybnikov]
Regarding claim 2, Soto in view of Dumpe and Rybnikov discloses all the limitations of claim 1 [see rejection of claim 1 above]
Soto further discloses a second component [element 201; see FIG. 5] with a component body [elements 203 and 207 are the element body] and connector socket [element 206; see FIGs. 4-5]; wherein the connector socket comprises:
a coupling socket [element 308; see FIG. 7A and [0137]] configured to receive at least one of the four coupling studs when the coupling socket moves along a first direction relative to the at least one of the four coupling studs; [see FIG. 8a-b; the coupling studs can enter the socket and attach to the second component]
a partial collar structure; and [the second end 307 and the walls w1 and w2 make up the exterior surface which makes the partial collar structure; see FIG. 7A and [0137]]
a release mechanism hinged to the component body with a movable terminal edge in a distal relationship to the hinge; [clamp handle 312; see FIG. 8a-b and [0141]]
wherein the release mechanism is configured to oppose a biasing force that is directed opposite the first direction; [see [0142]; the clamp handle and jaw 312-314 secure the coupling stud (tracker interface 206)]
wherein the partial collar structure is configured to engage the narrow neck portion of the distally positioned locking stud adjacent the tapered head portion when the at least one of the four coupling studs is received in the coupling socket in the first direction and the movable terminal edge of the release mechanism is adjacent a surface of the tapered head; [see FIG. 13C; the coupling stud 308 is received in the narrow neck portion and it is adjacent to the release mechanism 312]
and wherein an application of a release force on the release mechanism in the direction of the biasing force releases the engagement of the partial collar structure with the narrow neck portion and causes the coupling socket to move opposite the first direction. [see [0155]-[0156]; the release of the latch allows the stud 308 to be removed; see FIG. 13B-C ]
Regarding claim 3, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Dumpe further discloses that the tapered head portion exhibits a narrowing head circumference in a direction away from the handheld grip portion. element 514B is the equivalent to the locking stud as they engage the bone and lock the connector to the bone; see FIG. 8; and [0176]]; it includes a tapered end]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto in view of Dumpe and Rybnikov further such that the tapered head portion exhibits a narrowing head circumference in a direction away from the handheld grip portion according to the teachings of Dumpe in order for the tip to be able to secure in connection with the further elements using it’s pointed tip.
Regarding claim 5, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Dumpe further discloses that each of the four coupling studs exhibit a cylindrical shape. [see FIG. 8; each of the coupling studs 506a-C are a cylinder]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto in view of Dumpe and Rybnikov further such that each of the four coupling studs exhibit a cylindrical shape according to the teachings of Dumpe in order to allow for smooth coupling with the socket.
Regarding claim 6, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Soto further discloses that the application of the release force causes the second component to disengage from the first component in the direction of the release force. [see [0155]-[0156]; the release of the latch allows the stud 308 to be removed; see FIG. 13B-C ; the latch is pulled towards the same direction as the stud is being reoved]
Regarding claim 7, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Soto further discloses that when the partial collar structure engages the narrow neck portion of the distally positioned locking stud adjacent the tapered head portion, and when the movable terminal edge of the release mechanism is adjacent a surface of the tapered head, the movable terminal edge of the release mechanism is configured to apply a force along the axis of symmetry of the locking stud in the direction of the first component. [see FIG. 13C; the coupling stud 308 is received in the narrow neck portion and it is adjacent to the release mechanism 312]
Regarding claim 8, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Soto further discloses that the release mechanism is a button release. . [the release switch 226 may be a button; see [0184] and FIG. 4 of Soto]
Regarding claim 9, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Soto further discloses that the movable terminal edge is between the hinge and the coupling socket. [see FIG. 4 of Soto]
Regarding claim 10, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 1 [see rejection of claim 1 above]
Soto further discloses that the first component is a handheld probe with a pointer structure [see FIG. 4; the structure can be held in hand and is resembles a pointer structure. The examiner notes that the term “pointer structure” has been interpreted in the broadest reasonable interpretation as any structure that is pointed at the end] such that the connector is situated along the component axis in a distal relationship with the pointer structure and the handgrip portion lies between the pointer structure and the connector. [see FIG. 4 of Soto]
Regarding claim 11, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Rybnikov, directed towards tracking and registration of surgical devices [see abstract of Rybnikov] further discloses that the surgical component is a paddle attachment and the component body is a paddle body [see FIG. 27; element 24 is attached at the end and is a paddle structure]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto as modified by Dumpe and Rybnikov further such that the surgical component of Soto would be in the form of a paddle attachment and the component body is a paddle body according to the teachings of Rybnikov since doing so would have been substituting a type of tracking end device with another equivalent tracking end device shape and would have been obvious to try to a person of ordinary skill in the art. (KSR Rationale B)
Regarding claim 12, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Soto further discloses that the first component is a handheld probe with a pointer structure [see FIG. 4; the structure can be held in hand and is resembles a pointer structure. The examiner notes that the term “pointer structure” has been interpreted in the broadest reasonable interpretation as any structure that is pointed at the end] such that the connector is situated along the component axis in a distal relationship with the pointer structure and the handgrip portion lies between the pointer structure and the connector. [see FIG. 4 of Soto]
Regarding claim 13, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 12 [see rejection of claim 12 above]
the handheld probe with the pointer structure is configured to enable registration of points of interest on a patient. [see [0103] of Soto]
Regarding claim 14, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 12 [see rejection of claim 12 above]
Rybvnikov further disclose that the paddle attachment, in combination with the handheld probe, is configured to enable navigation of surgical cutting jigs. [see [0082] of Rybnikov]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto as modified by Dumpe and Rybnikov further such that the paddle attachment, in combination with the handheld probe, is configured to enable navigation of surgical cutting jigs according to the teachings of Rybnikov in order to allow for the use of the navigation tool in surgical procedures involving cutting [see [0082] of Rybnikov]
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Soto et al. (U.S. Publication No. 2023/0397961) hereinafter “Soto” in view of Dumpe et al. (WO 2021/127,161) hereinafter “Dumpe” and Rybnikov et al. (WO 2025/153,975) hereinafter “Rybnikov” as applied to claim 1 above, and further in view of Anderson et al. (U.S. Patent No. 5,481,634) hereinafter “Anderson”.
Regarding claim 4, Soto in view of Dumpe and Rybnikov discloses all the limitations of Claim 2 [see rejection of claim 2 above]
Soto in view of Dumpe and Rybnikov does not expressly disclose that the hinge is a living hinge.
Anderson, directed towards a surgical device with a hinged attachment [see abstract of Anderson] further discloses that the hinge is a living hinge. [see column 3, lines 32-50 discloses a latch for a surgical coupling with a living hinge]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto further such that the hinge is a living hinge according to the teachings of Anderson in order to allow the handle of the hinge to move up and down [see column 3, lines 32-50 of Anderson]. Further, doing so would have been substituting a type of hinge with another equivalent hinge and would have been obvious to try to a person of ordinary skill in the art. (KSR Rationale B)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Soto et al. (U.S. Publication No. 2023/0397961) hereinafter “Soto” in view of Rybnikov et al. (WO 2025/153,975) hereinafter “Rybnikov”.
Regarding claim 16, Soto discloses all the limitations of Claim 15 [see rejection of claim 15 above]
Soto does not expressly disclose that the surgical component is a paddle attachment and the component body is a paddle body.
Rybnikov, directed towards tracking and registration of surgical devices [see abstract of Rybnikov] further discloses that the surgical component is a paddle attachment and the component body is a paddle body [see FIG. 27; element 24 is attached at the end and is a paddle structure]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto further such that the surgical component of Soto would be in the form of a paddle attachment and the component body is a paddle body according to the teachings of Rybnikov since doing so would have been substituting a type of tracking end device with another equivalent tracking end device shape and would have been obvious to try to a person of ordinary skill in the art. (KSR Rationale B)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Soto et al. (U.S. Publication No. 2023/0397961) hereinafter “Soto” in view of Anderson et al. (U.S. Patent No. 5,481,634) hereinafter “Anderson”.
Regarding claim 17, Soto discloses all the limitations of Claim 15 [see rejection of claim 15 above]
Soto does not expressly disclose that the hinge is a living hinge.
Anderson, directed towards a surgical device with a hinged attachment [see abstract of Anderson] further discloses that the hinge is a living hinge. [see column 3, lines 32-50 discloses a latch for a surgical coupling with a living hinge]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Soto further such that the hinge is a living hinge according to the teachings of Anderson in order to allow the handle of the hinge to move up and down [see column 3, lines 32-50 of Anderson]. Further, doing so would have been substituting a type of hinge with another equivalent hinge and would have been obvious to try to a person of ordinary skill in the art. (KSR Rationale B)
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795