DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 23 June 2026. Claims 1-5 and 10-20 are currently pending.
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 2-5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (International Publication WO 2021/207471) in view of Fitzpatrick et al. (U.S. Patent 5,551,429).
Henderson et al. disclose (as to part of claim 2) a registration system (see Figure 1) compatible with a surgical navigation system having a processor (30, see paragraph 0046) and a localizer (26) connected to (i.e. via the use of optical cameras 28a and 28b) the processor comprising a probe (10) having a probe body (12) and a first array of markers (18a, 18b and 18c) connected to the probe body, each of the markers being detectable by (i.e. via 28a and 28b) the localizer, the probe having a probe tip (14) disposed at an end (i.e. end defining 14) of the probe body, the probe tip having an apex (i.e. apex defined at free end of 14), a central axis (i.e. axis defined along and through center of 12/14) extending through the apex, and an outer surface (i.e. surface defining outer periphery of 14) extending away from the apex; and an implant (20, i.e. as 20 is capable of being fixed to bone for repair, it is being interpreted as a generic implant, see Note below regarding the term “implant”) being connectable to a bone (B, see paragraph 0043) and having an exterior surface (i.e. surface defining 24), the exterior surface having a plurality of indentations (24, see paragraph 0043) extending therein, each of the indentations having an apex (i.e. apex not shown, but defined by surface extending within 24 for contact with 14), a central axis (i.e. axis defined along and through center of 24) extending through the apex of the indentation, and an inner surface (i.e. surface defining inner periphery of 24) extending away from the apex of the indentation, wherein the outer surface of the probe tip and inner surface of each of the indentations are configured such that, when the probe tip is fully received in any one of the indentations, the apex of the probe tip engages the apex of the indentation such that a location each apex is coincident (i.e. due to complementary shapes of 14 and 24, see paragraph 0043), wherein (as to claim 3) the outer surface of the probe tip has a convex curvature (e.g. in the event that the indentation is a divot or recession, and due to 14 and 24 having complementary shapes) defining a first radius of curvature (e.g. in the event that the indentation is a divot or recession, and due to 14 and 24 having complementary shapes) extending from the central axis of the probe tip to the outer surface (see paragraph 0043), wherein (as to claim 4) the inner surface of each of the indentations has a concave curvature (e.g. in the event that the indentation is a divot or recession) defining a second radius of curvature (e.g. in the event that the indentation is a divot or recession) extending from the central axis of the indentation to the inner surface, the second radius of curvature being equal to the first radius of curvature (i.e. due to 14 and 24 having complementary shapes, see paragraph 0043), and wherein (as to claim 10) the system is capable of further comprising a reference tracker (e.g. 20b) having a body (e.g. body similar to 21) connectable to a bone (B) and a second array of markers (e.g. markers similar to 22a-22d) connected to the body, each of the markers of the second array capable of being detectable by the localizer (see paragraphs 0047-0049) (see Figures 1-9B, and paragraphs 0029-0072).
Henderson et al. teach wherein the plurality of indentations are capable of taking on a feature (e.g. a shape of a divot or recession) capable of receiving the probe tip, and wherein the probe tip and indentations are capable of being complementary in cross-section (see paragraph 0043); however, fail to explicitly disclose wherein (as to the remainder of claim 2) the inner surface of each of the indentations is a surface of revolution extending symmetrically about the central axis of the indentation and including a spherical portion extending from the apex and a conical portion extending from the spherical portion, wherein (as to claim 5) the first radius of curvature is 1 mm, wherein (as to claim 11) a depth of each indentation as measured from the apex of the indentation to an opening of the indentation is 0.3 mm to 0.5 mm, and wherein (as to claim 12) a plane tangent to the outer surface of the probe tip forms an angle of 60 degrees relative to the central axis of the probe tip.
Fitzpatrick et al. teach the use of a probe (50) having a probe body (i.e. body defined by 50), the probe having a probe tip (52) disposed at an end (i.e. end defining 52) of the probe body, the probe tip having an apex (i.e. apex defined at free end of 52), a central axis (i.e. axis defined along and through center of 50/52) extending through the apex, and an outer surface (i.e. surface defining outer periphery of 52) extending away from the apex; and an implant (10, i.e. as 10 is capable of being fixed to bone for repair, it is being interpreted as a generic implant, see Note below regarding the term “implant”) being connectable to a bone (i.e. via 32) and having an exterior surface (e.g. surface defining 134), the exterior surface having an indentation (134) extending therein, the indentation having an apex (i.e. apex defined by surface extending within 134 for contact with 52), a central axis (i.e. axis defined along and through center of 134) extending through the apex of the indentation, and an inner surface (i.e. surface defining inner periphery of 134) extending away from the apex of the indentation, the inner surface of the indentation being a surface of revolution (i.e. due to spherical shape) extending symmetrically about the central axis of the indentation (see Figure 5A), and including a spherical portion (i.e. portion defined by 134) extending from the apex (see column 4, lines 51-53), wherein the outer surface of the probe tip and inner surface of the indentation are configured such that, when the probe tip is fully received in the indentation, the apex of the probe tip engages the apex of the indentation such that a location of each apex is coincident (i.e. due to complementary shapes of 52 and 134) (see Figures 2A-5A, and column 3, line 34 – column 6, line 29). Furthermore, Fitzpatrick et al. teach wherein the indentation includes a conical portion (i.e. portion defined by 434), wherein the indentation is capable of including any shape that provides a fixed mating surface for the probe tip of the probe to be employed (see column 4, lines 51-64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Henderson et al. with wherein the inner surface of each of the indentations is a surface of revolution extending symmetrically about the central axis of the indentation and including a spherical portion extending from the apex and a conical portion extending from the spherical portion, wherein the first radius of curvature is 1 mm, wherein a depth of each indentation as measured from the apex of the indentation to an opening of the indentation is 0.3 mm to 0.5 mm, and wherein a plane tangent to the outer surface of the probe tip forms an angle of 60 degrees relative to the central axis of the probe tip in view of the teachings of Henderson et al. and Fitzpatrick et al. in order to provide a desired complementary probe tip shape/configuration for physically contacting the plurality of indentations and provide a fixed mating surface for the probe tip of the probe to be employed to yield predictable results. Furthermore, the applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a probe tip curvature (In re Dailey and Eilers, 149 USPQ 47 (1966)), and such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955)).
Note: For examination purposes and in light of the broadest reasonable interpretation, the term “implant” is being interpreted as a device or material used for repairing or replacing part of the body (definition retrieved from https://www.thefreedictionary.com/implant).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (International Publication WO 2021/207471) in view of Fitzpatrick et al. (U.S. Patent 5,551,429), as applied to claim 2 above, further in view of Ching et al. (U.S. Patent Application Publication 2016/0100773).
Henderson et al. disclose wherein (as to part of claim 13) the implant includes a bone facing/contacting side (i.e. side facing/contacting B as best seen in Figure 3); however, Henderson et al. in view of Fitzpatrick et al. fail to explicitly disclose wherein (as to the remainder of claim 13) the implant is a patient specific implant, and the bone contacting surface that is capable of conforming to a surface of the bone.
Ching et al. teach the use of a device (100, i.e. similar in function to the interpreted implant as disclosed by Henderson et al.) that is patient specific (see paragraph 0017), and includes a bone contacting surface (104) capable of conforming to a surface of a bone (B) (see Figures 1A-1D, and paragraphs 0015-0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Henderson et al. in view of Fitzpatrick et al. with wherein the implant is a patient specific implant, and the bone contacting surface that is capable of conforming to a surface of the bone in view of Ching et al. in order to provide a well-known, obvious means for improving registration accuracy to yield predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (International Publication WO 2021/207471) in view of Fitzpatrick et al. (U.S. Patent 5,551,429) further in view of Ching et al. (U.S. Patent Application Publication 2016/0100773), as applied to claim 13 above, and further in view of Mahfouz (U.S. Patent 10,441,362).
Henderson et al. disclose (as to part of claim 14) the device having a registration side (i.e. side visible in Figure 3) opposite the bone facing side and being connectable to a bone (see paragraph 0040) and Ching et al. teach the device having a registration side (i.e. side visible in Figure 1A) opposite the bone facing side and being connectable to a bone (see paragraph 0087); however, Henderson et al. in view of Fitzpatrick et al. further in view of Ching et al. fail to explicitly disclose wherein (as to the remainder of claim 14) the implant includes a plurality of screw holes extending through the registration side and the bone facing side of the implant.
Mahfouz teaches the use of a device (200) capable of being used in a registration process, wherein the device includes a plurality of screw holes (220) extending through a first side (i.e. side defining 216) and a bone facing side (i.e. side defining 214) (see Figures 11 and 12, and column 5, line 48 – column 6, line 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Henderson et al. in view of Fitzpatrick et al. further in view of Ching et al. with wherein the implant includes a plurality of screw holes extending through the registration side and the bone facing side of the implant in view of Mahfouz in order to provide a well-known, obvious means for connecting the implant to a bone to yield predictable results.
Response to Arguments
The applicant’s arguments with respect to claims 2-5 and 10-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Statement of Reasons for Allowance
Claims 1 and 16-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter. The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the underlined limitations below, the following:
Regarding claim 1, a registration system compatible with a surgical navigation system having a processor and a localizer, comprising: a probe having a probe body and a probe tip disposed at an end of the probe body, the probe tip having an apex, a central axis extending through the apex, and an outer surface extending away from the apex; and an implant being connectable to a bone and having an exterior surface, the exterior surface having a plurality of registration features extending therein, each of the registration features having an apex, a central axis extending through the apex of the registration feature, and an inner surface extending about the apex of the registration feature, wherein a location of the apex of the probe tip within an intraoperative coordinate space is detected at any given time by the localizer and communicated to the processor, and wherein the outer surface of the probe tip and inner surface of each registration feature of the plurality of registration features are configured such that, when the probe tip is fully received in any one of the registration features, the apex of the probe tip engages the apex of the registration feature such that the locations of the probe tip and registration feature are coincident, and wherein a bone facing side of the implant includes a bone contacting surface that is configured to conform to a surface of the bone and a porous material configured to promote bony ingrowth.
Regarding at least claim 16, a method of registration in a robotic or computer assisted surgical procedure, comprising: connecting a reference tracker to a bone; positioning an implant adjacent to the bone; digitizing the reference tracker, the implant, and the bone within a first intraoperative coordinate system of a surgical navigation system; performing a first registration by: determining within the first intraoperative coordinate system a first position of the bone and a first position of the implant relative to a first position of the reference tracker, wherein the first position of the implant is determined by using a probe having a probe tip with an apex to engage an apex of an indentation of the implant, and aligning the first positions of the bone, the implant, and the reference tracker in the first intraoperative coordinate system with corresponding first positions within a pre-operative coordinate system based on a first registration transformation, and responsive to movement of the reference tracker relative to the bone after the aligning step, performing a second registration by: determining a second position of the implant relative to a second position of the reference tracker within a second intraoperative coordinate system, and aligning the second position of the reference tracker to a corresponding second position within the pre-operative coordinate space based on a second registration transformation and the second position of the reference tracker relative to the second position of the implant.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims (see “Allowable Subject Matter” section in the Non-Final Rejection mailed on 23 March 2026).
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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