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 .
Election/Restrictions
Applicant’s election without traverse of Species A, shown in Figs. 4A-B, in the reply filed on March 6, 2026, is acknowledged.
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.
Claims 1, 6-11 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezach (US 2020/0268452 A1).
Regarding claim 1, Rezach discloses a method of installing a modular orthopedic fixation device in bone, the method comprising:
attaching a screw extender instrument (driver 18; Figs. 2, 15-16; para. 0051) to a modular screw (22; Figs. 2-9) having a screw head (26; Fig. 3) and a shaft (see Fig. 3), wherein the screw extender instrument includes an outer sleeve (34; Figs. 2, 15-16) and an inner shaft (32; Figs. 2, 15-16) extending through the outer sleeve receivable in a recess (30; Figs. 2-9, 15) in the screw head (as described in para. 0051-0052), wherein movement (shown by arrow A; Fig. 15) of the outer sleeve or inner shaft secures the screw extender instrument to the screw head (see para. 0052; Fig. 15);
inserting the modular screw into bone with the screw extender instrument (see para. 0052; Fig. 15); and
connecting a tulip head assembly (28; Figs. 5-9; para. 0049) to the screw head (26; Figs. 5-9), wherein the tulip head assembly includes a tulip head having two arms defining a rod slot therebetween (as shown, two arms defining cavity/slot 56; Figs. 5-9; para. 0056), a saddle (crown 54; Figs. 6-9) received in a first groove (52; Fig. 6) and a clip (circumferential ring 44; Figs. 5-9; para. 0054) received in a second groove (defined by channels 46 and 48, collectively; Figs. 5-9; para. 0054), wherein when the screw head contacts a bottom of the clip (shown between Figs. 5-8), the clip moves upward to an upper portion of the second groove (clip/ring 44 moves upward to upper channel portion 48 of second groove 46/48, as shown between Figs. 5-7), and expands the clip until the screw head passes through the clip, thereby assembling the tulip head to the screw (as shown; Figs. 5-9).
Regarding claim 6, Rezach discloses the method of claim 1, further comprising attaching a navigated inserter instrument (navigation component 58; Fig. 2; para. 0059) having tracking elements (fiducial markers 80 of emitter array 62; Fig. 2; para. 0068) to the screw extender instrument (18; Fig. 2).
Regarding claim 7, Rezach discloses the method of claim 6, further comprising inserting the attached modular screw into bone while the tracking elements of the navigated instrument is being monitored by a camera tracking system (inserting screw 22 with screw extender driver instrument 18, at step 760 in Fig. 10B, is performed while tracking elements 80 of navigated instrument 58 are monitored by imaging/camera sensor array 60 to acquire data points of screw shaft 22, at step 860 in Fig. 10B; also see Figs. 1-2; para. 0068, 0078, 0085-0086).
Regarding claim 8, Rezach discloses the method of claim 1, further comprising recording a final inserted position of the modular screw (at step 860/865 in Fig. 10B, acquiring data points of screw shaft 22 subsequent to insertion step 760 and manipulation step 770, and transmitting these data points to store within a database; para. 0085, 0095).
Regarding claim 9, Rezach discloses the method of claim 8, further comprising continuously tracking a position of the bone to which the modular screw has been inserted based on the final inserted position of the modular screw and a tracking array attached to a patient (para. 0070 teaches that the surgical navigation system “registers the patient anatomy with respect to the location of robot 86, which includes the location of the robot’s end effector 20, such that robotic arm 14 extends and moves relative to a base of robot 86 to assist in surgical procedures” and para. 0074 recites that “patient anatomy and robot 86 may each have reference markers […] which are visible by the surgical navigation system 16” so that the real-time tracking of the position of screw 22 relative to the inserter instrument 18 and tissue described in para. 0068 involves tracking a position of the bone based on the final position of the screw 22 and fiducials attached to the patient during manipulation of vertebrae at steps 770, 870 in Fig. 10B; also see para. 0088-0089, 0095).
Regarding claim 10, Rezach discloses the method of claim 8, further comprising continuously tracking a position of the bone to which the modular screw has been inserted based on a position of the attached screw extender instrument (para. 0070 teaches that the surgical navigation system “registers the patient anatomy with respect to the location of robot 86, which includes the location of the robot’s end effector 20, such that robotic arm 14 extends and moves relative to a base of robot 86 to assist in surgical procedures” and para. 0074 recites that “patient anatomy and robot 86 may each have reference markers […] which are visible by the surgical navigation system 16” so that the real-time tracking of the position of screw 22 relative to the inserter instrument 18 and tissue described in para. 0068 involves tracking a position of the bone based on the final position of the inserter instrument 18 during manipulation of vertebrae at steps 770, 870 in Fig. 10B; also see para. 0088-0089, 0095).
Regarding claim 11, Rezach teaches a method of installing an orthopedic fixation device in bone, the method comprising:
attaching a screw extender instrument (driver 18; Figs. 2, 15-16; para. 0051) to a bone screw (22; Figs. 2-9) having a screw head (26; Fig. 3) and a shaft (see Fig. 3), wherein the screw extender instrument includes an outer sleeve (34; Figs. 2, 15-16) and an inner shaft (32; Figs. 2, 15-16) extending through the outer sleeve receivable in a recess (30; Figs. 2-9, 15) in the screw head (as described in para. 0051-0052), wherein movement (shown by arrow A; Fig. 15) of the outer sleeve or inner shaft secures the screw extender instrument to the screw head (see para. 0052; Fig. 15) such that a central longitudinal axis of the bone screw is aligned with a central longitudinal axis of the screw extender instrument (as shown in Fig. 2);
attaching a navigated inserter instrument (navigation component 58; Fig. 2; para. 0059) to the screw extender (as shown in Fig. 2), wherein the navigated inserter instrument includes tracking elements that are trackable by a camera tracking system (fiducial markers 80 of emitter array 62, trackable by imaging sensor array 60; Figs. 1-2; para. 0068);
inserting the bone screw into bone with the attached navigated inserter instrument while monitoring the position of the tracking elements by the camera tracking system (inserting screw 22 with screw extender driver instrument 18, at step 760 in Fig. 10B, is performed while tracking elements 80 of navigated instrument 58 are monitored by imaging/camera sensor array 60 to acquire data points of screw shaft 22, at step 860 in Fig. 10B; also see Figs. 1-2; para. 0068, 0078, 0085-0086); and
connecting a tulip head assembly (28; Figs. 5-9; para. 0049) to the screw head (26; Figs. 5-9), wherein the tulip head assembly includes a tulip head having two arms defining a rod slot therebetween (as shown, two arms defining cavity/slot 56; Figs. 5-9; para. 0056).
Regarding claim 15, Rezach teaches the method of claim 11, further comprising recording a final inserted position of the bone screw (where at least para. 0068 describes “real-time tracking”, steps 860/865 in Fig. 10B of acquiring the position of screw 22 and storing this data, subsequent to inserting the screw at step 760, include recording a final inserted position of the bone screw; para. 0088).
Regarding claim 16, Rezach teaches the method of claim 15, wherein recording a final inserted position includes recording based on monitoring of a position of the tracking elements (as described above, via monitoring position of fiducials 80 via sensor array 60; Figs. 1-2, 10B; para. 0068, 0088).
Regarding claim 17, Rezach teaches the method of claim 15, further comprising continuously tracking a position of the bone to which the bone screw has been inserted based on the final inserted position of the bone screw and a tracking array attached to a patient (para. 0070 teaches that the surgical navigation system “registers the patient anatomy with respect to the location of robot 86, which includes the location of the robot’s end effector 20, such that robotic arm 14 extends and moves relative to a base of robot 86 to assist in surgical procedures” and para. 0074 recites that “patient anatomy and robot 86 may each have reference markers […] which are visible by the surgical navigation system 16” so that the real-time tracking of the position of screw 22 relative to the inserter instrument 18 and tissue described in para. 0068 involves tracking a position of the bone based on the final position of the screw 22 and fiducials attached to the patient during manipulation of vertebrae at steps 770, 870 in Fig. 10B; also see para. 0088-0089, 0095).
Regarding claim 18, Rezach teaches the method of claim 15, further comprising continuously tracking a position of the bone to which the modular screw has been inserted based on a position of the attached screw extender instrument (para. 0070 teaches that the surgical navigation system “registers the patient anatomy with respect to the location of robot 86, which includes the location of the robot’s end effector 20, such that robotic arm 14 extends and moves relative to a base of robot 86 to assist in surgical procedures” and para. 0074 recites that “patient anatomy and robot 86 may each have reference markers […] which are visible by the surgical navigation system 16” so that the real-time tracking of the position of screw 22 relative to the inserter instrument 18 and tissue described in para. 0068 involves tracking a position of the bone based on the final position of the inserter instrument 18 during manipulation of vertebrae at steps 770, 870 in Fig. 10B; also see para. 0088-0089, 0095).
Regarding claim 19, Rezach teaches the method of claim 18, wherein the continuously tracking of the bone position is performed based on monitoring of a plurality of tracking markers of the screw extender instrument (the continuous tracking described above in claim 18 is based on monitoring tracking markers/fiducials 80 of screw extender driver instrument 18; Figs. 1-2; para. 0068).
Regarding claim 20, Rezach teaches the method of claim 19, wherein the tracking markers are disposed along the central longitudinal axis of the screw extender instrument (as shown in Fig. 2, tracking markers/fiducials 80 are disposed alongside a central axis of instrument 18).
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 1-5 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Biester (US 2019/0150989 A1) in view of Rezach (US 2020/0268452 A1).
Regarding claim 1, Biester teaches a method of installing a modular orthopedic fixation device in bone, the method comprising:
attaching a screw extender instrument (driver instrument 700; Fig. 7A, 7E-G; para. 0198-0199) to a modular screw (400) having a screw head (402) and a shaft (404), wherein the screw extender instrument includes an outer sleeve (counter-torque sleeve704; Figs. 7A-B; para. 0216) and an inner shaft (driver shaft 702; Figs. 7A-B) extending through the outer sleeve receivable in a recess (threaded distal end 702d receivable in threaded internal cavity 414 defining a drive interface of screw 400 drive interface defined by distal cavity 412 and proximal cavity 410; Figs. 4F-G; para. 0193) in the screw head, wherein movement of the outer sleeve or inner shaft secures the screw extender instrument to the screw head (inner driver shaft 702 is rotated relative to outer sleeve 704 to secure threads on distal end 702d of the inner shaft to the threaded recess of the screw head 402, and outer sleeve 704 is moved relative to inner shaft 702 so that sleeve abutment surfaces 724 bear against abut surfaces 424 of the screw head; Figs. 7A-7G ; para. 0217-0218);
inserting the modular screw into bone with the screw extender instrument (para. 0216 recites “driver instrument 700 that can be used to drive bone anchors into the bone, e.g., bone anchors of the type shown in FIGS. 4F-4G”); and
connecting a tulip head assembly to the screw head (tulip receiver member 200 coupled to head 402 of screw 400 using a head insertion instrument 1100 shown in Figs. 11A-11H; para. 0200), wherein the tulip head assembly includes a tulip head having two arms (202, 204; Figs. 2A-2J; para. 0167) defining a rod slot (206; Fig. 2A) therebetween, a saddle (collet 300; Figs. 1A-1H).
Examiner also notes that, in another embodiment (shown in Figs. 14A-14K, described in para. 0272-0273), Biester discloses a tulip head assembly (1400) having a saddle (1402/1404) and a clip (1302).
However, Biester does not disclose wherein the tulip head assembly includes “a saddle received in a first groove and a clip received in a second groove, wherein when the screw head contacts a bottom of the clip, the clip moves upward to an upper portion of the second groove, and expands the clip until the screw head passes through the clip, thereby assembling the tulip head to the screw”.
Rezach, in analogous art, discloses a method of installing a fixation device in bone, the method comprising: attaching a screw extender instrument (driver 18; Figs. 2, 15-16; para. 0051) to a modular screw (22) having a screw head (26; Fig. 3) and a shaft (see Fig. 3); inserting the modular screw into bone with the screw extender instrument (see para. 0052; Fig. 15); and connecting a tulip head assembly (28; Figs. 5-9; para. 0049) to the screw head (26; Figs. 5-9), wherein the tulip head assembly includes a tulip head having two arms defining a rod slot therebetween (as shown, two arms defining cavity/slot 56; Figs. 5-9; para. 0056), a saddle (crown 54; Figs. 6-9) received in a first groove (52; Fig. 6) and a clip (circumferential ring 44; Figs. 5-9; para. 0054) received in a second groove (defined by channels 46 and 48, collectively; Figs. 5-9; para. 0054), wherein when the screw head contacts a bottom of the clip (shown between Figs. 5-8), the clip moves upward to an upper portion of the second groove (clip/ring 44 moves upward to upper channel portion 48 of second groove 46/48, as shown between Figs. 5-7), and expands the clip until the screw head passes through the clip, thereby assembling the tulip head to the screw (as shown; Figs. 5-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Biester’s tulip head assembly to include the internal structures/configuration of Rezach described above, i.e. having a saddle received in a first groove and a clip in a second groove where the clip moves upward as the screw head contacts a bottom thereof as claimed, because where Biester recognizes alternate internal configurations within the tulip head assembly for securing the screw head therein (e.g., the embodiment of Figs. 14A-14K noted above, as well as other embodiments shown in Figs. 13A-13F and 13G-13K), Rezach recognizes that providing the tulip head assembly with a saddle and clip configured in the claimed manner is a suitable structure for receiving and retaining the screw head of a bone screw (see Rezach, Figs. 1-9).
Regarding claim 2, Biester and Rezach disclose the method of claim 1, and Biester discloses wherein during installation, the tulip head assembly (200; Figs. 11E-11H; para. 0109-0112) is engaged with a head inserter instrument (1100; Figs. 11A-11H; para. 0200) having an external sleeve (1104; Figs. 11A-11H; para. 0238) with inwardly facing prongs (defined by arcuate shelves 1112; Figs. 11C, 11E-11F; para. 0238) configured to engage with a groove (210; Figs. 2A-2B, 11E; para. 0169, 0238) on an outside of the tulip head (as shown; Figs. 2A-2B, 11E).
Regarding claim 3, Biester and Rezach disclose the method of claim 2, and Biester discloses wherein the head inserter instrument (1100; Figs. 11A-11H) includes a sensing pin (1106; Figs. 11A-11H) extending beyond the external sleeve (1104, as shown; Figs. 11A, 11E-11H), wherein when the sensing pin is depressed by the screw head, the external sleeve is released from the tulip head (see Figs. 11E-11H, para. 0238-0245).
Regarding claim 4, Biester and Rezach disclose the method of claim 1 and Biester teaches the method further comprising positioning a rod (R1; Figs. 1A-1B, 12H-12K) between the two arms and into the rod slot of the tulip head (see Figs. 1A, 12H-12K).
Regarding claim 5, Biester and Rezach disclose the method of claim 4 and Biester teaches the method further comprising threading a locking cap (102; Figs. 1A-1B, 12J-12K) downwardly between the two arms of the tulip head, wherein the rod presses against the saddle, and the saddle presses against the screw head, thereby securing the rod and the modular screw (as shown in at least Figs. 1F-1G, described in para. 0165 and 0259).
Regarding claim 11, Biester discloses a method of installing an orthopedic fixation device in bone, the method comprising:
attaching a screw extender instrument (driver instrument 700; Fig. 7A, 7E-G; para. 0198-0199) to a bone screw (400; Figs. 1A-H, 7A, 7E-G) having a screw head (402) and a shaft (404), wherein the screw extender instrument includes an outer sleeve (counter-torque sleeve704; Figs. 7A-B; para. 0216) and an inner shaft (driver shaft 702; Figs. 7A-B) extending through the outer sleeve receivable in a recess (threaded distal end 702d receivable in threaded internal cavity 414 defining a drive interface of screw 400 drive interface defined by distal cavity 412 and proximal cavity 410; Figs. 4F-G; para. 0193) in the screw head, wherein movement of inner shaft relative to the outer sleeve secures the screw extender instrument to the screw head such that a central longitudinal axis of the bone screw is aligned with a central longitudinal axis of the screw extender instrument (inner driver shaft 702 is rotated relative to outer sleeve 704 to secure threads on distal end 702d of the inner shaft to the threaded recess of the screw head 402, and outer sleeve 704 is moved relative to inner shaft 702 so that sleeve abutment surfaces 724 bear against abut surfaces 424 of the screw head, with central longitudinal axes of the instrument 700 and bone screw 400 aligned as shown; Figs. 7A-7G ; para. 0217-0218);
inserting the bone screw into bone (para. 0216 recites “driver instrument 700 that can be used to drive bone anchors into the bone, e.g., bone anchors of the type shown in FIGS. 4F-4G”); and
connecting a tulip head assembly to the screw head (tulip receiver member 200 coupled to head 402 of screw 400 using a head insertion instrument 1100 shown in Figs. 11A-11H; para. 0200), wherein the tulip head assembly includes a tulip head having two arms (202, 204; Figs. 2A-2J; para. 0167) defining a rod slot (206; Fig. 2A) therebetween.
Biester does not disclose the steps of: attaching a navigated inserter instrument to the screw extender, wherein the navigated inserter instrument includes tracking elements that are trackable by a camera tracking system, and inserting the bone screw into bone with the attached navigated inserter instrument while monitoring the position of the tracking elements by the camera tracking system.
Rezach, in analogous art, discloses a method of installing a fixation device in bone, the method comprising: attaching a screw extender instrument (driver 18; Figs. 2, 15-16; para. 0051) to a modular screw (22) having a screw head (26; Fig. 3) and a shaft (see Fig. 3); attaching a navigated inserter instrument (navigation component 58; Fig. 2; para. 0059) to the screw extender (as shown in Fig. 2), wherein the navigated inserter instrument includes tracking elements that are trackable by a camera tracking system (fiducial markers 80 of emitter array 62, trackable by imaging sensor array 60; Figs. 1-2; para. 0068); inserting the bone screw into bone with the attached navigated inserter instrument while monitoring the position of the tracking elements by the camera tracking system (see para. 0052, Figs. 1-2, 10B and 15 describing monitoring position of tracking emitter array 62 by system 60 during manipulation/insertion of screw 22, and “real-time tracking” recited in para. 0068, 0088, 0097, 0116 and 0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Biester’s system and method for installing the bone screw to further include attaching Rezach’s navigated inserter instrument to the screw extender and inserting the bone screw while monitoring the position of the tracking elements of the navigated inserter instrument by Rezach’s camera tracking system, as claimed, utilizing such a surgical navigation system aids in overcoming visibility obstruction and/or visibility challenges associated with screw shank location (see Rezach, para. 0031, 0102).
Regarding claim 12, Biester and Rezach disclose the method of claim 11, and Biester discloses wherein during installation, the tulip head assembly (200; Figs. 11E-11H; para. 0109-0112) is engaged with a head inserter instrument (1100; Figs. 11A-11H; para. 0200) having an external sleeve (1104; Figs. 11A-11H; para. 0238) with inwardly facing prongs (defined by arcuate shelves 1112; Figs. 11C, 11E-11F; para. 0238) configured to engage with a groove (210; Figs. 2A-2B, 11E; para. 0169, 0238) on an outside of the tulip head (as shown; Figs. 2A-2B, 11E).
Regarding claim 13, Biester and Rezach disclose the method of claim 12, and Biester discloses wherein the head inserter instrument (1100; Figs. 11A-11H) includes a sensing pin (1106; Figs. 11A-11H) extending beyond the external sleeve (1104, as shown; Figs. 11A, 11E-11H), wherein when the sensing pin is depressed by the screw head, the external sleeve is released from the tulip head (see Figs. 11E-11H, para. 0238-0245).
Regarding claim 14, Biester and Rezach disclose the method of claim 11 and Biester teaches the method further comprising positioning a rod (R1; Figs. 1A-1B, 12H-12K) between the two arms and into the rod slot of the tulip head (see Figs. 1A, 12H-12K; para. 0165, 0167, 0187).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant prior art references can be found in the attached PTO-892, including Ghanam (US 2020/0360106 A1) teaching a surgical navigation system and Whipple (US 2016/0206357 A1) teaching a tulip head assembly with a saddle and a clip received in first and second grooves, respectively.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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