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 .
Response to Arguments
Applicant's arguments filed June 22nd, 2026 have been fully considered but they are not persuasive. Applicant’s arguments that Bonutti et al. fail to teach the newly amended subject matter are not found persuasive to overcome the prior art of record. Under the new interpretation of Bonutti et al. all of the claimed features are anticipated. The inclusion of at least one implant can be found throughout Bonutti and includes but it not limited to the implants of figures 3E, 3F and/or 368, figures 22A/22B and/or 670, figures 44A-44B all of which have thermoplastic properties and an axially extending cavity seen in each respective figure which houses the tapered tip of the sonotrode. All of the implants are capable of undergoing liquification and re-solidification (¶222-223, ¶306). In at least these exemplary embodiments of Bonutti et al. (if not others) the sonotrode and the implant are configured such that the tapered tip is exclusively in contact with the axially extended cavity of the implant figures 3E, 3F, 22A-B, 44A-44B) only the tip is inserted into the cavity and therefore is exclusively in contact with the cavity).
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 1-10 and 12-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonutti et al. (US 2008/0021747).
Regarding claim 1, Bonutti et al. disclose a kit of parts comprising at least one implant (cylindrical block in figures 3E, 3F and/or 368, figures 22A/22B and/or 670, figures 44A-44B) having thermoplastic properties and an axially extending cavity (cavity which houses 124E/126F, figures 3E, 3F), and a sonotrode for inserting and fixating the implant having thermoplastic properties in a recess of an object by liquification and re-solidification (¶306), wherein the sonotrode comprises a body (figure 3E, or alternatively figures 22A-22B, 57A-57D) having a proximal end for attaching an ultrasound generating device (e.g. 150, figure 6, 152, figure 7 and 154, figure 8A), a distal end (see figure below), a tapered tip (124e, 362, “chamfered distal portion” ¶351, figures 57A-57D) at the distal end of the body, wherein the tapered tip is tapered towards a distal end of the tip and wherein the tapered tip is configured to receive an implant having thermoplastic properties by inserting the tip at least partially into a cavity of the implant (“channel” ¶282 figures 22A-22B/¶246, “anchor bore” ¶352), and a z-axis from the distal end of the tapered tip to the proximal end of the body, wherein an area of the tapered tip at the distal end of the body projected onto a plane normal to the z-axis fully covers an area of the distal end of the body projected onto the plane normal to the z-axis (figures 3E/22A-22B/57A-57D), wherein the sonotrode and the implant are configured such that the tapered tip is exclusively in contact with the axially extended cavity of the implant (figures 3E, 3F, 22A-B, 44A-44B) only the tip is inserted into the cavity and therefore is exclusively in contact with the cavity).
Regarding claim 2, Bonutti et al. disclose the area of the body projected onto the plane normal to the z-axis is constant along the z-axis from the proximal end of the body to the distal end of the body or decreases along the z-axis from the proximal end of the body to the distal end of the body (figures 3E, 22A).
Regarding claim 3, Bonutti et al. disclose the body is essentially cylindrical (figure 22A) and a largest diameter of the tapered tip is the same or larger than the diameter of the body at the distal end of the body (figure 22A).
Regarding claim 4, Bonutti et al. disclose the tapered tip has a cone shape (figure 3E, 22A).
Regarding claim 5, Bonutti et al. disclose the tapered tip ends in a flat tip (figure 22A) or in a pointy tip (figure 3E).
Regarding claim 6, Bonutti et al. disclose the body and the tapered tip are one piece or two pieces, wherein the two pieces are separable or not separable (figures 3E/22A).
Regarding claim 7, Bonutti et al. disclose the body is prismatic or essentially cylindrical (figures 3E/22A/57A-57D) and has a diameter of 2 mm to 20 mm (¶438 0.18” = 4.57 mm).
Regarding claim 8, Bonutti et al. disclose the tapered tip has a cone shape (figures 3E/22A/57A-57D) and at least one of: a largest diameter of 2 mm to 8 mm, a smallest diameter of 0.1 mm to 3 mm, a length along the z-axis of 1 mm to 10 mm, and a taper angle α of 1 degree to 20 degrees (¶438 0.18” = 4.57 mm).
Regarding claim 9, Bonutti et al. disclose the body is essentially cylindrical (figure 22A), the tapered tip has a cone shape (362) and the sonotrode has at least one of: a largest diameter of 2 mm to 20 mm, a smallest diameter of 0.1 mm to 3 mm, a length along the z-axis of 5 mm to 400 mm, and a taper angle α of the tapered tip of 1 degree to 20 degrees (¶438 0.18” = 4.57 mm).
Regarding claim 10, Bonutti et al. disclose the sonotrode is suitable to operate between 15 kHz and 45 kHz (¶260, ¶324). Regarding claim 11, Bonutti et al. disclose the sonotrode is configured to have operate between 10 kHz and 45 kHz (¶260, ¶324) and 5 W to 150 W (¶235).
However, Bonutti et al. fails to expressly teach or disclose an amplitude at the tapered tip of 10 µm to 45 µm when operated, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the sonotrode to have an amplitude at the tapered tip of 10 µm to 45 µm when operated between 10 kHz and 45 kHz (¶260, ¶324) and 5 W to 150 W (¶235), as it is a known workable amplitude range for the use of a sonotrode to soften a thermoplastic material anchor between 10 kHz and 45 kHz and 5 W to 150 W.
Regarding claim 12, Bonutti et al. disclose the sonotrode is made of steel, titanium, cobalt-based alloys, ceramic, silicon nitride, silicon carbide, zirconia, or an aluminum-zirconia alloy (¶237).
Regarding claim 13, Bonutti et al. disclose an implant (368, figure 22A) having thermoplastic properties plugged onto the tapered tip (figures 22A-22B), wherein the sonotrode and the implant are configured such that the tapered tip is exclusively in contact with a cavity in the implant (“channel” ¶282).
Regarding claim 14, Bonutti et al. disclose the cavity is an axially extended opening in direction of the z-axis (figures 22A-22B).
Regarding claim 15, Bonutti et al. disclose the tapered tip and the implant are configured such that implants of different sizes can be plugged onto the tapered tip (capable, based on the channel seize ¶282).
Regarding claim 16, Bonutti et al. disclose the implant having thermoplastic properties is a pin or a suture anchor (¶358-359, ¶379). Regarding claim 17, Bonutti et al. disclose the implant having thermoplastic properties is a pin or a suture anchor (¶358-359, ¶378).
Regarding claim 18, Bonutti et al. disclose an apparatus for fixating an implant in a recess of an object comprising the sonotrode according to claim 1 and an ultrasound generating device (150, figure 6/152, figure 7/154, figure 8B) attached to the proximal end of the body.
Regarding claim 19, Bonutti et al. disclose the apparatus is configured to at least one of: operate between 10 kHz and 45 kHz (¶260, ¶324), have an amplitude at the tapered tip of 10 µm to 45 µm when operated between 10 kHz and 45 kHz and 2 W to 150 W, or both.
Regarding claim 20, Bonutti et al. disclose a pin or a suture anchor (figure 22A, 59, 72-73), having thermoplastic properties plugged onto the tapered tip, wherein the tapered tip is exclusively in contact with an axially extended opening in the pin or anchor in direction of the z-axis (figures 22A, 59, 72-73). Regarding claim 21, Bonutti et al. disclose the suture anchor has a suture conduit (876, figure 59) at a distal end of the anchor.
Regarding claim 22, Bonutti et al. disclose a kit of parts comprising the sonotrode according to claim 1 and an ultrasound generating device suitable for attachment to the proximal end of the body (150, figure 6/152, figure 7, 154, figure 8B).
Regarding claim 23, Bonutti et al. disclose at least one implant (figure 22A, 59, 72-73) having thermoplastic properties suitable for being plugged onto the tapered tip (¶217, ¶246, ¶250). Regarding claim 24, Bonutti et al. disclose the kit comprises at least two implants of different sizes (¶338, ¶511). Regarding claim 25, Bonutti et al. disclose the at least one implant is a pin or suture anchor (Figures 22A/59/72-73), wherein the tapered tip and the pin or suture anchor are configured such that the tapered tip is exclusively in contact with an axially extended opening in the pin or anchor in direction of the z-axis (figures 22A/59/72-73).
Regarding claim 26, Bonutti et al. disclose the at least one implant is a pin or suture anchor (figures 22A/59/727-73), wherein the tapered tip and the pin or suture anchor are configured such that the tapered tip is exclusively in contact with an axially extended opening in the pin or anchor in direction of the z-axis, and wherein the suture anchor has a suture conduit (876, figure 59) at a distal end of the anchor (figure 59).
Regarding claim 27, Bonutti et al. disclose the at least one implant is a pin or suture anchor (figure 59), wherein the tapered tip and the pin or suture anchor are configured such that the tapered tip is exclusively in contact with an axially extended opening in the pin or anchor in direction of the z-axis, wherein the suture anchor has a suture conduit at a distal end of the anchor, and wherein the kit of parts further comprises a suture suitable for being threaded through the suture conduit or being threaded through the suture conduit (figure 59, 876, ¶358).
Regarding claim 28, Bonutti et al. disclose a method for assembling a device for fixating at least one implant having thermoplastic properties in a recess of an object, the method comprising the steps of: providing the sonotrode according to claim 1 (360, figure 22A/852, figures 57A-57D, ¶356), an ultrasound generating device (150, figure 6/152, figure 7/154, figure 8B) and at least one implant having thermoplastic properties (368/870), and in any order: attaching the ultrasound generating device to the proximal end of the body (figures 22A-B/57A-59), and plugging a proximal end of the at least one implant onto the tapered tip of the sonotrode (figures 22A-B/57A-C), wherein the sonotrode and the implant are configured such that the tapered tip is exclusively in contact with an axially extended opening in the implant in direction of the z-axis (figures 22A-B/57A-59).
Regarding claim 29, Bonutti et al. disclose the implant is a pin or a suture anchor (figures 22A-B/57A-59).
Regarding claim 30, Bonutti et al. disclose the implant is a suture anchor (figure 59) that comprises a suture (¶358, figure 59) threaded through a suture conduit (876) at a distal end of the suture anchor or wherein the method further comprises threading a suture through a suture conduit at a distal end of the suture anchor (figure 59).
Regarding claim 31, Bonutti et al. disclose a method for fixating at least one pin or at least one suture with at least one suture anchor in a recess of an object, the method comprising the steps of: (a) providing the sonotrode according to claim 1 (360, figure 22A-B/852, figures 57A-D ¶356) and attaching an ultrasound generating device (150, figure 6/152, figure 7/156, figure 8A) to the proximal end of the body, (b) providing at least one pin (368, figures 22A-22B) having thermoplastic properties or at least one suture anchor (866/870) having thermoplastic properties and comprising a suture (¶358, figure 59) in a conduit (876) at a distal end of the anchor or providing at least one suture anchor having thermoplastic properties and threading a suture through a conduit at a distal end of the suture anchor (figure 59), (c) plugging the at least one pin or suture anchor onto the tapered tip of the sonotrode such that the tapered tip is exclusively in contact with an axially extended opening in the pin or anchor in direction of the z-axis (figures 22A-22B/57A-59, ¶356), and (d) providing an object (370/860) with a recess having a cross-section corresponding to the cross-section of the at least one pin or suture anchor, or having a cross-section that is smaller than the cross-section of the at least one pin or suture anchor to the extent that an insertion of the at least one pin or suture anchor is possible (figures 22A-22B/figure 58), followed by (e) inserting the at least one pin or suture anchor into the recess of the object while transmitting ultrasound from the sonotrode to the at least one pin or suture anchor for a time sufficient to liquify the at least one pin or suture anchor to the extent that liquification results in fixation of the pin or suture by means of the at least one anchor in the recess (figures 22A-22B/57-58).
Regarding claim 32, Bonutti et al. disclose after step (e) the method comprises repeating step (b) with a further pin or suture anchor of the same or of a different size compared to the at least one pin or suture anchor of previous step (b), followed by repeating steps (c) to (e) with the further pin or suture anchor, wherein the steps (b) and (c) to (e) are repeated at least once in this sequence (figure 58, another 866).
Regarding claim 33, Bonutti et al. disclose the object is a human, animal or artificial hard tissue, a cartilage-covered hard tissue, or an implant structure (figures 22A/58).
Regarding claim 34, Bonutti et al. disclose the object is a human, animal or artificial hard tissue, a cartilage-covered hard tissue, or an implant structure, and wherein at least one of: the hard tissue is a hard tissue sample outside of the human or animal body, a hard tissue of a dead body or a hard tissue of a human or animal patient, (372, figure 22A-22B/862, figure 58) and the implant structure is a fixation plate or bone plate (372, figures 22A-22B ¶283/860, figure 58, ¶356).
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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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