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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02-10-2026 has been entered.
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.
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, 9, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gullotti et al. (U.S. Pub. 2019/0209080).
Regarding claim 1, Gullotti discloses (Figs. 14-15 and 28) a device for computer aided surgery (see par. [0027]), comprising:
a body 1510 [0541] (as shown in Figs. 15A-C);
an optical element 1525 [0541] (Figs. 15A-C) coupled to the body 1510 (as shown in Figs. 15A-C);
a fiducial (1515: [0539]-[0541]; Figs. 14-15) coupled to the body 1510 (as shown in Figs. 15A-C); and
at least one calibration element 1505/1560 (probe/tip: [0541]; is used in a calibration procedure: [0795]) formed on the body 1510 (as shown in Figs. 15A-C);
wherein the calibration element 1505/1560 includes a pointer extension post 1505 and a pointer tip 1560 [0541] extending from the body 1510 (as shown in Figs. 15A-C).
Gullotti does not disclose that the calibration element is integrally formed on the body, however, such a modification (to make one part integral to another) would be obvious – see MPEP 2144.04(V)(B) – “the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”
Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the calibration element is integrally formed on the body.
Regarding claim 3, Gullotti discloses (Figs. 14-15 and 28) the device comprises at least three fiducials 1515 (as shown in Figs. 15A-C).
Regarding claim 9, Gullotti does not disclose that the pointer tip 1560 is removable from the pointer extension post 1505, however, such a modification (to make one part separable from another) would be obvious – see MPEP 2144.04(V)(C).
Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the pointer tip is removable from the pointer extension post.
Regarding claim 10, Gullotti discloses (Figs. 14-15 and 28) the pointer tip 1560 is affixed to the pointer extension post 1505 on the body 1510 (as shown in Figs. 15A-C).
Regarding claim 12, Gullotti discloses (Figs. 14-15 and 28) a computer [0496], wherein the device is used in connection with the computer for surgical registration [0027], and wherein the computer is configured to perform a surgical registration using at least one of: data representing an actual as-is manufactured locations of the optical element 1525, the fiducial 1515, and the calibration element 1560 (i.e. during a calibration process, all these elements are tracked/registered, meaning data is recorded for each: see Fig. 82A-B; [0795]).
Claims 2, 4-6, 13-16, 19, 20, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gullotti et al. (U.S. Pub. 2019/0209080) in view of Lennertz et al. (U.S. Pub. 2018/0116746).
Regarding claim 13, Gullotti discloses (Figs. 14-15 and 28) a device for computer aided surgery (see par. [0027]), comprising:
a body 1510 [0541] (as shown in Figs. 15A-C);
an optical element 1525 [0541] (Figs. 15A-C) coupled to the body 1510 (as shown in Figs. 15A-C), wherein the optical element 1525 is configured to be visible to a location camera (see pars. [0536] and [0544])
at least one calibration element 1505/1560 (probe/tip: [0541]; is used in a calibration procedure: [0795]) formed on the body 1510 (as shown in Figs. 15A-C), wherein the optical element 1525, the fiducial (per the combination, below), the body 1510, and the calibration element 1560 are held in relation to each other in a fixed position (as shown in Figs. 15A-C);
wherein the calibration element 1505/1560 includes a pointer extension post 1505 and a pointer tip 1560 [0541] extending from the body 1510 (as shown in Figs. 15A-C).
Gullotti does not disclose that the calibration element is integrally formed on the body, however, such a modification (to make one part integral to another)would be obvious – see MPEP 2144.04(V)(B) – “the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”
Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the calibration element is integrally formed on the body.
Gullotti also does not disclose a fiducial, wherein the fiducial is radiopaque.
Lennertz discloses (Figs. 1-4) a fiducial 31 [0052] coupled to the body 1 (as shown in Fig. 1) wherein the fiducial 31 is radiopaque [0040].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device to include a fiducial, wherein the fiducial is radiopaque, as taught by Lennertz.
Such a modification would further assist in the tracking of the surgical tool.
Regarding claim 2, Gullotti’s device is applied as above (see the rejection of claim 1, above), but does not disclose that the device comprises at least three optical elements.
Lennertz discloses (Figs. 1-4 and 8) the device comprises at least three optical elements 6 (as shown in Figs. 1 and 8: Fig. 8 shows a third element 6 on one of the other legs).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the device comprises at least three optical elements, as taught by Lennertz.
Such a modification would further assist in the tracking of the surgical tool.
Regarding claims 4, 6, 14, and 16, Gullotti’s device/modified device is applied as above, but does not disclose the calibration element includes a calibration divot forming an indentation on the body configured to receive a surgical instrument; wherein the calibration divot further comprises a conical positioning divot.
Lennertz discloses (Figs. 1-4) the calibration element 5/34 includes a calibration divot 5/34 [0051] forming an indentation on the body 1 [0051] configured to receive a surgical instrument [0051]; and the calibration divot further comprises a conical positioning divot 5/34 (as shown in Figs. 1 and 4: the divot has a round base with straight angled sides that meet at a middle point, i.e. a conical shape; see par. [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the calibration element includes a calibration divot forming an indentation on the body configured to receive a surgical instrument; wherein the calibration divot further comprises a conical positioning divot, as taught by Lennertz.
Such a modification would be the combination of prior art elements according to known methods to yield predictable results – see MPEP 2143(I)(A).
Regarding claims 5 and 15, Lennertz is applied as above, but does not disclose the calibration divot further comprises a flat cylindrical positioning divot.
However, such a modification would be merely a change in shape of the divot, whichi is obvious – see MPEP 2144.04(IV)(B). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lennertz so that the calibration divot further comprises a flat cylindrical positioning divot.
Regarding claim 19, Gullotti does not disclose that the pointer tip 1560 is removable from the pointer extension post 1505, however, such a modification (to make one part separable from another) would be obvious – see MPEP 2144.04(V)(C).
Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the pointer tip is removable from the pointer extension post.
Regarding claim 20, Gullotti discloses (Figs. 14-15 and 28) the pointer tip 1560 is affixed to a pointer extension post 1505 on the body 1510 (as shown in Figs. 15A-C).
Regarding claim 22, Gullotti discloses (Figs. 14-15 and 28) a computer [0496], wherein the device is used in connection with the computer for surgical registration [0027], and wherein the computer is configured to perform a surgical registration using at least one of: data representing an actual as-is manufactured locations of the optical element 1525, the fiducial 1515, and the calibration element 1560 (i.e. during a calibration process, all these elements are tracked/registered, meaning data is recorded for each: see Fig. 82A-B; [0795]).
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gullotti et al. (U.S. Pub. 2019/0209080) in view of Jutras et al. (WO 2004/030555).
Also, claims 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gullotti et al. (U.S. Pub. 2019/0209080) in view of Lennertz et al. (U.S. Pub. 2018/0116746), and further in view of Jutras et al. (WO 2004/030555).
Regarding claims 8, 10-11, 18, and 20-21, Gullotti is applied as above, but does not disclose the pointer tip is adapted to receive a first pointer extension; the pointer tip is affixed to a pointer extension on the body; and a second pointer extension having a different length than the first pointer extension.
Jutras discloses (Figs. 1-10) the pointer tip 44 is adapted to receive a first pointer extension 44 (p. 10, linew 6-9; see Figs. 1-2); the pointer tip 44 is affixed to a pointer extension 44 on the body 42 (as shown in Figs. 1-2); and a second pointer extension 74 having a different length than the first pointer extension 44 (p. 12, lines 4-24; see Fig. 10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Gullotti’s device so that the pointer tip is adapted to receive a first pointer extension; the pointer tip is affixed to a pointer extension on the body; and a second pointer extension having a different length than the first pointer extension, as taught by Jutras.
Such a modification would allow different tips and pointer lengths to be attached to the body, and would be a combination of prior art elements according to known methods to yield predictable results – see MPEP 2144.03(I)(A).
Response to Arguments
Applicant's arguments filed 02-10-2026 have been fully considered but they are not persuasive. Applicant argues that the pointer extension post 1505 is not integrally formed with the body, however, a modification to Gullotti’s device to make the post integral with the body would be an obvious one – see MPEP 2144.04(V)(B) – “the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”
Applicant also argues that the probe/probe tip of Gullotti is not a calibration device, and argues that “a calibration element is a thing whose existence provides calibration.” However, the examiner fails to see how this definition of a calibration device excludes the probe and probe tip of Gullotti. In par. [0795], Gullotti describes that:
“…a non-tracked display monitor 8210 communicates calibration instructions 8205 and displays calibration markers 8230 on the display monitor to guide a user holding a 3D-tracked probe with triggering capability 8240 to calibrate the probe to the screen dimensions and location in space relative to the 3D-tracking camera by sequentially orienting the probe tip and its computed line of trajectory 8245 to each indicated marker on the display monitor…”
As can be seen from the quoted section of Gullotti, above, the probe and probe tip are used in a calibration procedure, and thus their existence provides calibration.
Furthermore, Applicant's arguments regarding the combination of Gullotti with Lennertz and Jutras fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Also, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Benjamin Schmitt, whose telephone number is (571) 270-7930. The examiner can normally be reached M-F | 8:30-5:00.
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/BENJAMIN R SCHMITT/Primary Examiner, Art Unit 2852