DETAILED ACTION
Notice of AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
Claim Objections
Claim 25 is objected to because of the following informalities: “…is configured to engagement with an aperture…” appears to contain a grammatical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim(s) 1-4, 6, 7, and 21-25 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, “downward” and “upward” are indefinite because it is unclear as to what direction is down or up with respect to the marker shaft.
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.
Claim(s) 1, 2, 4, 21, 23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sela (US 2017/0265943, of record).
Regarding claim 1, Sela discloses a surgical registration probe including: a marker shaft with at least one marker or fiducial, the marker shaft having a straight shape positioned along an axis; and a probe shaft having at least three segments (Figs. 6E-6G show at least three bends along the straight supporting structure of the markers). While Sela does not explicitly disclose angle values in the range of 20-120 degrees for each bend in the probe shaft, Sela does teach in Fig. 6G that the bends in the probe shaft approximately belong in that range:
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Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the angle bends of Sela, as to provide a way to properly position markers with respect to a probe shaft.
Regarding claim 2, Sela discloses that the marker shaft includes four markers or fiducials (Figs. 6E-6G show four markers/fiducials).
Regarding claim 4, while Sela does not explicitly disclose that the end of the probe shaft includes a spherical ball for placement against a patient’s skin, Sela does teach spherical balls at the end of a tracking device that may come into contact with a patient’s skin (Figs. 6E-6G). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the spherical balls of Sela, as to provide a conventional type of tracking marker.
Regarding claim 21, Sela discloses that the at least one marker or fiducial includes at least one spherical marker (Fig. 6G shows spherical markers).
Regarding claim 23, Sela discloses that the at least one marker is configured to be tracked by a localizer for surgical registration ([0057]: “tracking system 213 comprises at least one sensor”).
Regarding claim 24, Sela discloses a tip located at the end of the third segment (Fig. 6G shows a third segment that has a tip).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sela (US 2017/0265943, of record), as applied to claim 1 above, in view of Ohlhues (US 2013/0093866, of record).
Regarding claim 3, Sela does not explicitly disclose a mirror connected to at least one segment of the probe shaft and positioned to reflect an end of the probe shaft. However, Sela teaches an instrument access port ([0093]: “access port 680”) and Ohlhues teaches providing a mirror at a distal end of an instrument to enhance visibility ([0032]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the mirror of Ohlhues to the access port of Sela, as to provide enhanced and robust visualization at a distal end of a tracking marker.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sela (US 2017/0265943, of record), as applied to claim 1 above, in view of Jutras (US 2006/0015018, of record).
Regarding claims 6 and 7, Sela does not explicitly disclose that the surgical registration probe is reusable after sterilization using autoclave. However, Jutras teaches autoclaving a registration probe device ([0036]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the sterilization of Jutras to the device of Sela, as to provide a sterilized device.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sela (US 2017/0265943, of record), as applied to claim 1 above, in view of Lang (US 10292768).
Regarding claim 22, Sela does not explicitly disclose a marker with a grid pattern. However, Lang teaches an optical tracking marker with patterns or codes (44:53-67…45:1-45). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the optical marker of Lang to the marker system of Sela, as to provide a robust optical marker.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sela (US 2017/0265943, of record), as applied to claim 1 above, in view of Sheffer (US 2007/0038059).
Regarding claim 25, Sela does not explicitly disclose that the probe tip is configured to be engaged with an aperture or hole of a registration plate. However, Sheffer teaches touching the tip of a tracked probe against a device to register the tracked position of the probe ([0050]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the probe registration of Sheffer to the system of Sela, as to provide a conventional and robust manner of registering a probe.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/JASON M IP/Primary Examiner, Art Unit 3793
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