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 Amendment
The amendment filed on 04/06/2026 has been entered:
Claim 1 – 14, 17, 19, 22 and 26 – 28 remain pending in the application;
Claim 1, 3, 4, 6, 9 – 14, 17, 19, 22 and 26 – 28 are amended.
Applicant’s amendments to claim overcome each and every claim objection and 112 claim rejection as set forth in the Non-Final Office Action mailed on 01/13/2026. The corresponding claim objections and 112 claim rejections are withdrawn.
Response to Arguments
Applicant’s arguments with respect to the claim interpretation under 35 U.S.C. 112 (f) have been fully considered but they are not persuasive.
Regarding the 112 (f) claim interpretations, applicant submitted on p.7 – 8 that “In claims 1-3, 11, and 12 it is clear that "visualization means," "augmenting means," and "pattern recognition means" limitations represent structure that would be readily recognized by one of ordinary skill in the art. Thus, it is respectfully submitted that the interpretation of claims 1-3, 11, and 12 under 35 U.S.C. § 112(f) is neither necessary nor proper.” Applicant’s arguments have been fully considered but they are not persuasive.
As recited on p.7 – 9 of the Non-Final Office Action mailed on 01/13/2026, the limitations use the term “means” or “device” coupled with functional language without reciting any structure to perform the recited function. In addition, one of ordinary skill in the art would not recognize any structure information regarding those “means” or “device”. Such limitations must be interpreted according to the structural disclosure in the specification.
Therefore, all corresponding 112 (f) claim interpretation as set forth in the Non-Final Office Action mailed on 01/13/2026 are maintained.
Applicant’s arguments with respect to the rejections of claim 1 – 14, 17, 19, 22 and 26 – 28 under 35 U.S.C. 102/103 have been fully considered but they are not persuasive.
Regarding the rejection of independent claim 1, applicant submitted on p.8 – 10 that “It is not apparent, though, that Steinberg discloses a radio dense geometry "adapted for providing a unique radiographic projection for any proximal-to-distal orientation", i.e., a geometry that yields a unique projection for each possible orientation of the guiding body along its proximal-distal axis in the intended use orientation. Steinberg references to "comprehension of the orientation" (para. [0490]) and a "defined 3D arrangement" indicate that some orientation information can be derived, but they do not establish that the projection is unique across the full range of relevant orientations, nor do they exclude the possibility that different orientations could produce identical or ambiguous projections”; “Steinberg does not specify any radio dense geometry that is adapted to provide a unique radio projection for any proximal to distal orientation of a guiding body.”
Applicant’s arguments have been fully considered but they are not persuasive for the following reasons.
First, as recited in the Non-Final Office Action, Steinberg does teach a radio dense geometry which is in asymmetric form (“… by adding an additional radiopaque element to the tool (such as clip 180), such that the tool has at least two identifiable features in each 2D image, namely, its distal tip and the additional radiopaque element.” [0490]). It is clearly illustrated in Fig.24 that the clip 180 is arranged on the elongate member asymmetrically. The distal tip and the clip form the radio dense geometry.
Second, the unique projected pattern is the inherently result of asymmetric 3D pattern. This is fundamental fact in 3D geometry. The asymmetry breaks the possibility of generating two identical projections from any two angles. Such inherency can be evidenced in the cited prior art Gullotti (“… the arrangement of the radiopaque fiducial markers 444 can be designed in an asymmetric pattern to enable an X-ray image of the fiducial from any perspective to visualize a unique pose of the pattern and to subsequently enable the system to automatically estimate the 3D orientation of the fiducial 442.” [0505]).
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). See MPEP 2112.
Thus, applicant’s arguments regarding the rejection of independent claim 1 have been fully considered but they are not persuasive.
Regarding the rejection of all other corresponding dependent claims, applicant’s remarks submitted on p.10 rely on supposed deficiencies with the rejection of parent claim 1. Applicant’s arguments are not persuasive for the same reasons detailed above.
Overall, applicant’s remarks submitted on p.7 – 10 have been fully considered, but they are not persuasive. THIS ACTION IS MADE FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 18, limitation "a traveling path" should read "the traveling path".
Appropriate correction is required.
Claim Interpretation
The claim interpretation under 35 U.S.C. 112(f) as set forth in the Non-Final Office Action mailed on 01/13/2026 are maintained.
Claim Rejections - 35 USC § 102
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 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.
Claim 1 – 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinberg et al. (US 2020/0405399 A1; published on 12/31/2020) (hereinafter "Steinberg).
Regarding claim 1, Steinberg discloses a surgical guiding system for computer-assisted-surgery (CAS) ("… the following steps are typically performed during procedures that are performed on skeletal anatomy, using a system that includes a computer processor." [0015]), wherein the surgical guiding system comprises:
a surgical guiding device ("Reference is now made to FIG. 24, which is a schematic illustration of Jamshidi™ needle 36 …" [0490]) comprising:
a guiding body having a longitudinal extension from a proximal end of the surgical guiding device to a distal end of the surgical guiding device (see Fig.24, the elongated body), and being adapted for guiding at least one of a longitudinal surgical implant and a longitudinal surgical tool ("… the tool and/or implant is inserted by removing the inner tube of the Jamshidi™ needle, inserting a stiff wire through the outer tube, removing the outer tube, and then inserting the tool and/or implant along the stiff wire." [0236]), and having a guiding trajectory extending along the guiding body and succeeding in distal direction along a traveling path of at least one of the surgical implant and the surgical tool to be inserted and guided (see above citations, the stiff wire along the tube of Jamshidi needle is the guiding trajectory), and
a radio dense geometry being located in a predetermined spatial position and orientation with respect to the guiding body (“… by adding an additional radiopaque element to the tool (such as clip 180), such that the tool has at least two identifiable features in each 2D image, namely, its distal tip and the additional radiopaque element.” [0490]; see Fig.24 for position and orientation), and being adapted for providing a unique radio projection for any proximal to distal orientation of the guiding body in an intended use orientation of the surgical guiding device ("… the additional radiopaque element is configured to be have a defined 3D arrangement such that the additional radiopaque element provides comprehension of the orientation of the tool." [0490]; see Fig.24 that the clip 180 is arranged on the elongate member asymmetrically, and the distal tip and the clip form the asymmetric radio dense geometry; the unique projected pattern is the inherently result of asymmetric 3D pattern, which can be evidenced by later cited prior art Gullotti [0505]); and
an image processing device ("… by computer processor 22 of system 20, by means of image processing …" [0544]) comprising:
visualization means being adapted for a virtual visualization of the orientation of the guiding body with respect to a patient's anatomy ("The location of a portion of the tool with respect to the skeletal portion is identified within the first and second 2D x-ray images … Typically, an output is generated in response thereto (e.g., by displaying the derived location of the tool relative to the x-ray image view with respect to which the location has been derived)." [0544]), based on the unique radio projection of the radio dense geometry ("For some applications, the additional radiopaque element is configured to be have a defined 3D arrangement such that the additional radiopaque element provides comprehension of the orientation of the tool." [0490]), and
augmenting means being adapted for augmenting the guiding trajectory onto the virtual visualization of the orientation of the guiding body, so as to visualize a traveling path of at least one of the surgical implant and the surgical tool ("For example, based upon the determined location of at least the tip of the tool (or distal portion of the tool), the computer processor may drive the display to update the indication of the location of the tip of the tool (or distal portion of the tool) with respect to the vertebra with respect to the 3D image data. For some applications, the navigation systems comprise the use of augmented reality, or virtual reality, or robotic manipulation of tools, or any combination thereof." [0572]).
Regarding claim 2, Steinberg discloses all claim limitations, as applied in claim 1, and further discloses wherein the augmenting means further being adapted for augmenting a reproducible scale along the augmented guiding trajectory ("Typically, the tool is placed along the centerline at an appropriate scale with the dimensions being derived from the 3D image data." [0486]).
Regarding claim 3, Steinberg discloses all claim limitations, as applied in claim 1, and further discloses wherein the augmenting means further being adapted for augmenting a geometry related to an implant to be implanted with respect to the patient's anatomy ("… a cylindrical representation of the tool is overlaid upon the derived centerline upon the 3D image data." [0486]), based on the unique radio projection of the radio dense geometry ("For some applications, the additional radiopaque element is configured to be have a defined 3D arrangement such that the additional radiopaque element provides comprehension of the orientation of the tool." [0490]).
Regarding claim 4, Steinberg discloses all claim limitations, as applied in claim 1, and further discloses wherein the guiding body comprises a hollow shaft with a guiding channel, wherein the guiding channel is configured to follow the guiding trajectory ("A Jamshidi™ needle typically includes an inner tube and an outer tube … inserting a stiff wire through the outer tube, removing the outer tube, and then inserting the tool and/or implant along the stiff wire." [0236]).
Regarding claim 5, Steinberg discloses all claim limitations, as applied in claim 1, and further discloses wherein the guiding body has a straight trajectory ("… in the case of a tool with straight shaft in whole or in its distal portion, or one that may be assumed to be straight once inserted into bone, or at least straight in its distal portion once inserted into bone …" [0454]).
Regarding claim 6, Steinberg discloses all claim limitations, as applied in claim 5, and further discloses wherein the radio dense geometry comprises a first radio dense sub-geometry and a second radio dense sub-geometry ("… by adding an additional radiopaque element to the tool (such as clip 180), such that the tool has at least two identifiable features in each 2D image, namely, its distal tip and the additional radiopaque element." [0490]), wherein the first radio dense sub-geometry is provided at a proximal end of the surgical guiding device (see Fig.24, the position of clip 180) and the second radio dense sub-geometry is provided at a distal end of the surgical guiding device ("… namely, its distal tip …" [0490]), wherein a radio projection of the first sub-geometry and a radio projection of the second sub-geometry toward the straight longitudinal extension is configured to provide a radio projection, which is distinguishable from any other radio projection toward a direction different from the direction of the straight longitudinal direction ("… such that the tool has at least two identifiable features in each 2D image …" [0490]).
Regarding claim 7, Steinberg discloses all claim limitations, as applied in claim 6, and further discloses wherein the first radio dense sub-geometry and the second radio dense sub-geometry, each projected toward the straight longitudinal extension, have a complementary pattern (this is the inherent result of the structure as shown in Fig.24, where clip 180 and tool tip would be projected to be side by side).
Regarding claim 8, Steinberg discloses all claim limitations, as applied in claim 1, and further discloses wherein the guiding body has a bent trajectory ("Reference is now made to FIGS. 28A-E, which show an example of a tool bending during its insertion … and the dashed white line 376 is where the tool becomes further away from the anticipated longitudinal progression path." [0558]).
Regarding claim 9, Steinberg discloses all claim limitations, as applied in claim 8, and further discloses wherein the guiding body has the bent trajectory along a circle section ("Reference is now made to FIGS. 28A-E, which show an example of a tool bending during its insertion … and the dashed white line 376 is where the tool becomes further away from the anticipated longitudinal progression path." [0558]; bent line can be approximated by portion of a circle, which is inherently defined in geometry).
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.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Steinberg, as applied in claim 1, and further in view of Gullotti et al. (US 2019/0209080 A1; published on 07/11/2019) (hereinafter "Gullotti).
Regarding claim 10, Steinberg teaches all claim limitations, as applied in claim 1, except wherein the radio dense geometry comprises a third radio dense sub-geometry, which the third radio dense sub-geometry comprises a plurality of fiducial markers being distributed in the third radio dense sub-geometry such that the third radio dense sub-geometry has a unique projection in each projection direction.
However, in the same field of endeavor, Gullotti teaches wherein the radio dense geometry comprises a third radio dense sub-geometry ("FIG. 121A illustrates a perspective of an example embodiment of the X-Ray adapter device 12101 that contains three or more radiopaque fiducial spheres 12103 within the fiducial body 12105 …" [1338]; here the fiducial body 12105 is position on the proximal end of the instrument, which is different from where the position of clip 180 and tip as taught by Steinberg), which the third radio dense sub-geometry comprises a plurality of fiducial markers being distributed in the third radio dense sub-geometry such that the third radio dense sub-geometry has a unique projection in each projection direction ("... the arrangement of radiopaque fiducial spheres 12103 involves an asymmetric distribution of spheres in a 3D-offset pattern that produces a unique 3D pose for all rotational views of the sphere arrangement." [1338]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional proximal end fiducial device as taught by Gullotti. "with the engaged adapter device containing four radiopaque fiducial spheres arranged in a unique, asymmetric geometric distribution", it is possible to "facilitate auto-pose detection of the fiducial in X-Ray images relative to the detector imaging plane" (see Gullotti; [1339]).
Claim 11 – 14, 17, 19, 22 and 26 – 28 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg, as applied in claim 1, and further in view of Stemniski et al. (US 2024/0398489 A1; priority date on 05/20/2021) (hereinafter "Stemniski").
Regarding claim 11, Steinberg teaches all claim limitations, as applied in claim 1, except an optical imaging device representing a position and orientation of one of the surgical guiding device and a surgical reference body attachable to the patient's anatomy, the optical imaging device having a predetermined viewing direction; an optical pattern representing a position and orientation of the other of the surgical guiding device and said surgical reference body, the optical pattern having at least one unique optical sub-pattern, which is configured to allow determination of a relative position and orientation of said surgical reference body with respect to the position and orientation of said surgical guiding device; and the image processing device comprising: pattern recognition means being adapted for recognizing the position and orientation of the at least sub-pattern of the optical pattern with respect to a position and viewing direction of the optical imaging device based on an image taken from the optical imaging device and a stored representation of the optical pattern, and the visualization means being adapted for virtually visualizing the surgical guiding device represented by the respective one of the optical imaging device and the optical pattern and virtually visualizing a surgical reference body and patient's anatomy, respectively, represented by the respective other of the optical pattern and the optical imaging device.
However, in the same field of endeavor, Stemniski teaches an optical imaging device representing a position and orientation of one of the surgical guiding device ("FIG. 7A is an illustration of an operational jig 120 according to an embodiment of the present disclosure in which the reference body 200 includes an optical fiducial 220 that can be used by an optical imaging system to determine the position and orientation of the guide assembly 100." [0101]) and a surgical reference body attachable to the patient's anatomy ("The patient-matched guide body 110 can comprise a unitary block structure with bone engaging surface features configured for complementarily matching with anatomical surface features of a selected region of the patient's natural bone ..." [0038]), the optical imaging device having a predetermined viewing direction (viewing angle is inherent property of optical imaging device which defines FOV);
an optical pattern representing a position and orientation of the other of the surgical guiding device and said surgical reference body, the optical pattern having at least one unique optical sub-pattern, which is configured to allow determination of a relative position and orientation of said surgical reference body with respect to the position and orientation of said surgical guiding device ("The optical fiducial 220 has an optical pattern 80 thereon that is a unique pattern that can be recognized by the optical imaging system to determine the location and orientation of the structure, in this example the operational jig 120, on which the optical fiducial 220 is provided. The optical pattern 80 can be printed directly to the reference body 200." [0101]); and
the image processing device ("The optical system 700 can include a computing device 710 …" [0106]) comprising:
pattern recognition means being adapted for recognizing the position and orientation of the at least sub-pattern of the optical pattern with respect to a position and viewing direction of the optical imaging device based on an image taken from the optical imaging device ("The optical fiducial 220 has an optical pattern 80 thereon that is a unique pattern that can be recognized by the optical imaging system to determine the location and orientation of the structure …" [0101]) and a stored representation of the optical pattern ("… the optical pattern 80 on the optical fiducial 220 is a known parameter." [0103]; in image processing, known parameter is also a stored data), and
the visualization means being adapted for virtually visualizing the surgical guiding device represented by the respective one of the optical imaging device and the optical pattern and virtually visualizing a surgical reference body and the patient's anatomy, respectively, represented by the respective other of the optical pattern and the optical imaging device ("… the outline of the patient-matched guide body 110 can be extrapolated from the optical image of the optical pattern 80." [0104]; "The optical system 700 presents an optical digital image of the patient's anatomy and overlay the outline of the patient-matched guide body 110 on a display along with an overlaid image of the target outline of the patient-matched guide body 110 where the target outline represents the intended position of the patient-matched guide body 110 ..." [0105]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 12, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 11, and Stemniski further teaches wherein the image processing device further comprises:
the augmenting means being adapted for augmenting a predetermined operating trajectory of the surgical guiding device onto the virtual visualization of the surgical guiding device, based on the recognized position and orientation of the at least sub-pattern of the optical pattern with respect to the position and viewing direction of the optical imaging device, so as to visualize an operating path of the surgical guiding device relative to the surgical reference body and the patient's anatomy, respectively, represented by the optical pattern ("The optical system 700 presents an optical digital image of the patient's anatomy and overlay the outline of the patient-matched guide body 110 on a display along with an overlaid image of the target outline of the patient-matched guide body 110 where the target outline represents the intended position of the patient-matched guide body 110 so that a surgeon can visually assess the placement and orientation of the patient-matched guide body 110 relative to the intended placement and orientation and make appropriate adjustments." [0105]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 13, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 11, and Stemniski further teaches wherein the optical pattern is configured to form a reproducible relation between the geometry of the surgical guiding device and the position and orientation of the optical pattern ("Because the location of the optical fiducial 220 and the orientation of the optical pattern 80 thereon in relation to the structures of the components of the guide assembly 100 are known parameters, when the guide assembly 100 is viewed, along with the patient's body portion on which the guide assembly 100 is being placed, with an optical imaging device (i.e., an optical digital camera) the outline of the patient-matched guide body 110 can be extrapolated from the optical image of the optical pattern 80." [0104]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 14, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 11, and Stemniski further teaches wherein the optical imaging device is configured to form a reproducible relation between the geometry of the surgical guiding device and the position and orientation of the optical imaging device ("Because the location of the optical fiducial 220 and the orientation of the optical pattern 80 thereon in relation to the structures of the components of the guide assembly 100 are known parameters, when the guide assembly 100 is viewed, along with the patient's body portion on which the guide assembly 100 is being placed, with an optical imaging device (i.e., an optical digital camera) the outline of the patient-matched guide body 110 can be extrapolated from the optical image of the optical pattern 80." [0104]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 17, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 11, and Stemniski further teaches wherein the optical pattern is composed of a honeycomb raster of light and dark fields ("… the optical pattern 80 can be composed of a honeycomb raster of light and dark fields as shown in the example illustrated in FIG. 7B. The fields may be hexagonal or round fields, or have a shape which has a certain fit to a honeycomb raster." [0102]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 19, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 11, and Stemniski further teaches the surgical reference body attachable to the patient's anatomy, which the surgical reference body has mounted thereon the other of the optical imaging device and the optical pattern ("The patient-matched guide body 110 can comprise a unitary block structure with bone engaging surface features configured for complementarily matching with anatomical surface features of a selected region of the patient's natural bone ..." [0038]; "… in which the reference body 200 includes an optical fiducial 220 that can be used by an optical imaging system to determine the position and orientation of the guide assembly 100. The optical fiducial 220 has an optical pattern 80 ..." [0101]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 22, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 19, and Stemniski further teaches wherein the surgical reference body ('… both the radio-opaque markers 210 and the optical fiducial 220 features may be incorporated into the guide assembly 100." [0116]) comprises:
the radio dense geometry having a first radio dense sub-geometry, a second radio dense sub-geometry, and a third radio dense sub-geometry each being fixedly and spatially reproducibly connected to the surgical reference body ("The radio-opaque markers 210 can be pieces of radio-opaque material and can be provided in the reference body 200 in a three-dimensional cluster of predefined pattern." [0046]; see Fig.1A, each of the three surfaces has different pattern);
a first leg (see Fig.1A) having an anatomically adapted surface for the patient's anatomy ("The second side 102 is the side that engages the patient bone and the second side comprises at least one patient-specific surface PS that is configured for complementarily engaging the anatomical surface features of a target area of the patient's natural bone." [0042]); and
a second leg (see Fig.1A) having an anatomically adapted surface for the patient's anatomy ("The second side 102 is the side that engages the patient bone and the second side comprises at least one patient-specific surface PS that is configured for complementarily engaging the anatomical surface features of a target area of the patient's natural bone." [0042]),
wherein the first leg with a first end is connected to a first end of the second leg at a leg joining portion (see Fig.1A),
wherein each of the first radio dense sub-geometry, the second radio dense sub-geometry, and the third radio dense sub-geometry has a unique radio projection for each proximal to distal orientation of the surgical reference body, so that each of the first radio dense sub-geometry, the second radio dense sub-geometry, and the third radio dense sub-geometry alone is configured to allow determination of the spatial position and orientation of the surgical reference body based on a two dimensional radio projection of at least a part of the surgical reference body ("The pattern of the cluster of the radio-opaque markers 210 can be asymmetric to readily indicate the orientation, position, and attitude of the reference body 200 when viewed with a fluoroscope." [0047]),
wherein the first radio dense sub-geometry is allocated to a second end of the first leg (see Fig.1A, the left side surface is close to left leg), the second radio dense sub-geometry is allocated to a second end of the second leg (see Fig.1A, the right side surface is close to right leg), and the third radio dense sub-geometry is allocated to the leg joining portion of the first leg and the second leg (see Fig.1A, the front surface is close to the joining portion).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 26, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 22, and Stemniski further teaches wherein a sub-leg joining portion comprises at least one of the at least one apex-pin holes ("… the operational jig 120 is a pin guide comprising one or more pin guiding holes 124 for surgical pins …" [0083]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 27, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 22, and Stemniski further teaches wherein an angle between a first leg and a second leg at its joining point is less than 90° (see Fig.1A for the angle less than 90°).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Regarding claim 28, Steinberg in view of Stemniski teaches all claim limitations, as applied in claim 22, and Stemniski further teaches wherein an angle between a first sub-leg and a second sub-leg at its joining point is less than 90° (see Fig.1A for the angle less than 90°).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the surgical tool with tracking patterns as taught by Steinberg with the additional optical markers and tracking device as taught by Stemniski. By using optical fiducials, it is possible to provide additional information that "can be used during surgery to confirm that correct components are assembled for that specific surgery and side of the anatomy", in addition to pose tracking (see Stemniski; [0101]).
Conclusion
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Al Jewad et al. (US 2019/0380794 A1; published on 12/19/2019) teach a surgical robot system with asymmetric markers pattern to estimate instrument pose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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