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 set of claims received on 03 January 2024. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 03 January 2024 are accepted by the examiner.
Claim Rejections - 35 USC § 102
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 1-4 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henderson et al. (International Publication WO 2021/207471).
Regarding claim 1, Henderson et al. disclose a registration system (see Figure 1) compatible with a surgical navigation system having a processor (30, see paragraph 0046) and a localizer (26) comprising a probe (10) having a probe body (12) and 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 1 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 registration features (24, see paragraph 0043) extending therein, each of the registration features 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 registration feature, and an inner surface (i.e. surface defining inner periphery of 24) extending about the apex of the registration feature, wherein a location of the apex of the probe tip within an intraoperative coordinate space is capable of being detected at any given time by the localizer and communicated to the processor (see paragraph 0048, see Note 2 below regarding functional language), 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 (i.e. due to complementary shapes of 14 and 24, see paragraph 0043) (see Figures 1-9B, and paragraphs 0029-0072).
Regarding claims 2-4 and 10, Henderson et al. disclose (as to 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 1 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 about 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 indention 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).
Note 1: 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).
Note 2: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Claims 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spaelter et al. (U.S. Patent 11,337,761).
Spaelter et al. disclose (as to claim 16) a method (see Note 3 below regarding conditional/contingent limitations) of registration in a computer assisted surgical procedure (see Figure 1, and column 8, lines 33-57) comprising connecting a reference tracker (70A or 70B) to a bone (i.e. a femur) (see column 12, lines 51-67); positioning an implant (22) adjacent to the bone (see column 31, line 35 – column 32, line 18); digitizing the reference tracker, the implant, and the bone within a first intraoperative coordinate system (e.g. one of local or arbitrary aligning with 100C) of a surgical navigation system (i.e. digitized to be seen as VC) (see column 31, line
35 – column 32, line 18)); performing a first registration by (i.e. via 20) determining within the first intraoperative coordinate system a first position (e.g. position as best seen in Figure 8E) of the bone and a first position (e.g. position as best seen in Figure 8E) of the implant relative to a first position (e.g. position as best seen in Figure 8E) of the reference tracker (see column 15, lines 1-21, column 16, lines 9-63, and column 22, line 45 – column 24, line 2), and aligning the first positions of the bone, implant, and reference tracker in the first intraoperative coordinate system with corresponding first positions within a pre- operative coordinate system (e.g. the other of local or arbitrary) based on a first registration transformation (see column 16, lines 32-63), wherein (as to claim 17) the first registration transformation is capable of being a function of the first position of the reference tracker and the first position of the bone (see column 16, lines 32-63), and wherein (as to claim 20) the implant includes a bone facing side (i.e. side adjacent the femur as best seen in Figure 8F) and a registration side (i.e. visible side as best seen in Figure 8F), the registration side having a plurality of indentations (i.e. indentations defined by lateral sides extending into both the bone facing and registration sides as best seen in Figure 8A) extending therein (see Figures 1-9D, and column 7, line 48 – column 34, line 21).
Note 3: Since the method as recited in / required by claims 16 and 18-19 are conditional/contingent in nature and the condition that the first registration (i.e. as disclosed by Spaelter et al. and as interpreted by the examiner) has been performed (as recited in / required by claim 16), the following steps are not required to be performed (see MPEP 2111.04(II)):
Claim 16 - "if the reference tracker is moved 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;"
Claim 18 - "wherein the second registration transformation is a function of the first positions of the reference tracker, bone, and implant;” and
Claim 19 - "determining a second position of the bone relative to the second position of the reference tracker within the second intraoperative coordinate system based on the first positions of the bone and the implant relative to the first position of the reference tracker and the second position of the implant relative to the second position of reference tracker.”
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (International Publication WO 2021/207471), as applied to claim 4 above.
Henderson et al. disclose the claimed invention except for wherein the first radius of curvature is 1 mm.
However, 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).
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 first radius of curvature is 1 mm in view of the teaching of Henderson et al. in order to provide a desired complementary probe tip shape/configuration for physically contacting the plurality of indentations 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)).
Claims 6-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (International Publication WO 2021/207471), as applied to claim 2 above.
Henderson et al. disclose the claimed invention except for wherein (as to claim 6) the inner surface of each of the indentations is a surface of revolution extending symmetrically about the central axis of the indentation, wherein (as to claim 7) the inner surface is spherical, wherein (as to claim 8) the inner surface is conical, wherein (as to claim 9) the inner surface includes a spherical portion extending from the apex and a conical portion extending from the spherical portion, wherein (as to claim 11) a depth of each indentation as measured from the apex of the indention 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.
However, 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).
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, wherein the inner surface is spherical, wherein the inner surface is conical, and wherein the inner surface includes a spherical portion extending from the apex and a conical portion extending from the spherical portion, wherein a depth of each indentation as measured from the apex of the indention 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 teaching of Henderson et al. in order to provide a desired complementary probe tip shape/configuration for physically contacting the plurality of indentations 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)).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (International Publication WO 2021/207471), as applied to claim 2 above, 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, 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. 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 Ching et al. (U.S. Patent Application Publication 2016/0100773), as applied to claim 13 above, 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 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. 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.
Allowable Subject Matter
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.
The following is a statement of reasons for the indication of allowable subject matter. Claim 15 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the limitations required by claims 2 and 13-14, wherein the bone facing side of the implant includes a porous material configured to promote bony ingrowth.
Conclusion
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775