Ex Parte Appenzeller et al

Patent Trial and Appeal BoardSep 7, 2018

13793044 (P.T.A.B. Sep. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/793,044 03/11/2013 Andreas Appenzeller 76960 7590 09/10/2018 Fay Kaplun & Marcin, LLP 150 Broadway, suite 702 New York, NY 10038 UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. 10139/32401 (SYN1401USNP) CONFIRMATION NO. 5916 EXAMINER JOHANAS, JACQUELINE T ART UNIT PAPER NUMBER 3733 MAIL DATE DELIVERY MODE 09/10/2018 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANDREAS APPENZELLER, LADISLA V NAGY, DANIEL FLURI, CHRISTOF DUTOIT, and ANDRE GALM 1 Appeal2017-008208 Application 13/793,044 Technology Center 3700 Before RICHARD M. LEBOVITZ, MICHAEL J. FITZPATRICK, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. Â§ 134(a) involving claims to a styloid intramedullary device. 2 The Examiner's rejection of claims 1-13 and 21-23 under 35 U.S.C. Â§ 102(b) is appealed. 3 We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm-in-part. 1 The Real Parties in Interest are identified as "DePuy Synthes Products, Inc. and Universitat Zurich." Appeal Br. 2. And further, "Johnson & Johnson, Inc. is the parent corporation of DePuy Synthes Products, Inc." Id. 2 Herein we refer to the Specification of Mar. 11, 2013 ("Spec."); Final Office Action of Feb. 5, 2016 ("Final Action"); Advisory action of May 13, 2016 ("Advisory Action"); Appeal Brief of Oct. 28, 2016 ("Appeal Br."); Examiner's Answer of Mar. 29, 2017 ("Answer"); and Reply Brief of May 12, 2017 ("Reply Br."). 3 A rejection under 35 U.S.C. Â§ 112, first paragraph, has been withdrawn. Advisory Action. Appeal2017-008208 Application 13/793,044 STATEMENT OF THE CASE Independent claims 1 and 8, reproduced below, are representative: 1. A styloid intramedullary fixation device dimensioned to lie within a medullary canal of a distal radius when implanted, the styloid intramedullary fixation device comprising: a) a curvilinear body having a head portion and an end opposite the head portion, the curvilinear body elongate along a central axis from the head portion to the end such that the central axis lies in a first plane; b) a first insertion channel configured to accept a first bone screw, the first insertion channel having a first channel insertion point located at the head portion, a first channel exit point from the curvilinear body, and a first channel axis that extends centrally through the first channel insertion point and the first channel exit point such that, as the central axis extends in a direction from the head portion to the end, the central axis converges with the first channel axis at a select side of the first channel axis, then is tangent to the first channel axis at a tangent location, and then diverges from the first channel axis at the select side; and c) a second insertion channel configured to accept a second bone screw, the second insertion channel having a second channel insertion point located at the head portion, a second channel exit point located at the head portion, and a second channel axis that extends centrally, wherein the tangent location is disposed between the end and the second channel axis on a second plane that extends through the end, the tangent location, and the second channel axis, and the styloid intramedullary fixation device is devoid of an insertion channel that is configured to accept a bone screw and that has an exit point that is positioned closer to the end than the first channel exit point is positioned to the end. 8. A styloid intramedullary nail dimensioned to lie within a medullary canal of a distal radius when implanted, the styloid intramedullary fixation nail comprising: 2 Appeal2017-008208 Application 13/793,044 (a) a curvilinear body elongate along a central axis of the styloid intramedullary fixation nail, the curvilinear body having a head portion and a shaft portion terminating in an end opposite the head portion, the head portion defining a first width that is measured along a straight line perpendicular to the central axis, and the shaft portion defining a second width that is measured along a straight line perpendicular to the central axis and that is less than the first width, the central axis extending along a length of the body from the head portion to the end such that the central axis lies in a first plane; (b) a first insertion channel having a first channel insertion point into the curvilinear body and a first channel exit point from the curvilinear body, the first insertion channel configured to accept a first bone screw, the first insertion channel defining a first channel axis that extends centrally through the first channel insertion point and the first channel exit point such that the first channel axis intersects the central axis at a first point and a second point spaced from the first point along the length of the body, the first channel insertion point located within the head portion; and ( c) a second insertion channel having a second channel insertion point into the curvilinear body and a second channel exit point from the curvilinear body, the second insertion channel configured to accept a second bone screw, the second insertion channel defining a second channel axis that extends centrally through the second channel insertion point and the second channel exit point, the second channel insertion point and exit point located within the head portion; wherein the second channel axis diverges from the first plane, and the first channel axis diverges from a second plane that is orthogonal to the first plane. Appeal Br. 10-11, 12-13 (Claims Appendix). 3 Appeal2017-008208 Application 13/793,044 The following rejection is appealed: Claims 1-13 and 21-23 are rejected under 35 U.S.C. Â§ I02(b) as anticipated by Mazur. 4 Final Action 3. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision; arguments not so presented in the Briefs are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). "Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference." In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). The Examiner determined that the claims are anticipated by Mazur. See Final Action 3-24 and Answer 2-21 ( collectively citing Mazur abstract, ,r,r 13, 21, 88, 93, 95-97, 99, 106, 115, Figures llA-llD, 12A-I2D, 18A, 18B). Appellants have argued the claims in two groups, focusing on independent claim 1 and independent claim 8. We, therefore, address the claims on appeal in the same fashion and all claims stand or fall with the independent claims, respectively. We address Appellants' arguments below. 4 US 2011/0087227 Al (pub. Apr. 14, 2011) ("Mazur"). 4 Appeal2017-008208 Application 13/793,044 CLAIM] Appellants argue that Mazur fails to disclose the screw channel configuration required by claim 1, specifically that Mazur fails to show or suggest a styloid intramedullary fixation device "devoid of an insertion channel that is configured to accept a bone screw and that has an exit point that is positioned closer to the end than the first channel exit point is positioned to the end," as recited in claim 1. In support of the rejection, the Examiner created a marked version of up Fig. 11 C purportedly identifying a "first channel axis" extending from the proximal end of the hub 302 to a hole 316 on the convexly curved wall of the hub 302. Appeal Br. 5. In summary, Appellants contend Mazur does not disclose that a screw channel for a bone screw that tracks the central axis of the overall device for some part thereof has an exit hole closer to the device's distal end than the exit hole for any other similar screw. The Examiner's rationale in support of the rejection is adequately captured in the Examiner's annotated version of Mazur' s Figure 11 C, which is reproduced below: channel ax~ 5 tangfrnt kJcaoon ct-)ntral fix.IS 0 --- Appeal2017-008208 Application 13/793,044 Final Action 6. The Examiner's annotated Mazur Figure 1 lC shows a bone fixation device's hollow, tubular, curved hub portion having a threaded proximal end and several holes 316 for bone screws. Mazur ,r,r 92-95. The Examiner has labeled what she considers the respective bone screw holes that are insertion points and exit points using dashed arrows and has drawn what she considers the device's central axis and the first bone screw's channel, as partly and tangentially overlapping that axis. Appellants contend that the Examiner's analysis relating to the positioning of Mazur' s bone screws, and thus too the related channels, is not supported by Mazur's disclosure and amounts to "pure speculation." Appeal Br. 5---6. The Examiner determined that the first bone screw channel of the embodiment of Mazur' s Figure 11 C is provided for a bone screw to be inserted at the threaded proximal end opening of the device and extend to the hub's most distal bone screw opening in the fashion illustrated by the Examiner (above). Final Action 4--6. However, while the Mazur disclosure specific to Figures 1 lA-1 lD is not definitive as to what screw holes should be considered pairs for screw entry and exit (providing a channel there between), it is clear from Mazur's disclosure relating to its Figures 12A-12F that Mazur does not disclose what the Examiner interprets it to disclose. Regarding Figures 12A-12F, Mazur states "FIGS. 12A-12F show details of a curved hub 400 similar to hub 302 illustrated in FIGS. 11A- 11D." Mazur ,r 96. As to the screw holes illustrated in Figures 12A-12F (and also, relatedly, Figures 1 lA-1 lD), Mazur states: Exemplary hub 400 includes three holes 406, 408 and 410 through the wall thickness on its concave side, as best seen in FIG. 12C. Similarly, hub 400 includes four holes 412,414,416, 6 Appeal2017-008208 Application 13/793,044 and 418 through the wall thickness on its convex side, as best seen in FIG. l2D. At least a portion of all seven holes may be seen in FIG. 12F. Holes 406 and 412 on opposite sides of hub 400 are aligned to allow a bone screw to be inserted through the two holes across the hub to secure hub 400 to the bone and/or to secure bone fragment(s) with the screw. Similarly, holes 408 and 414 are aligned to receive a second bone screw, and holes 410 and 416 are aligned to receive a third bone screw. A fourth screw may be inserted through the open proximal end 402 of hub 400 and out through hole 418. Each screw may be passed first through cortical bone, then cancellous bone, then through the two holes of hub 400, through more cancellous bone and possibly into more cortical bone on the opposite side of the bone from where the screw entered. Mazur ,r 97. Thus, Mazur discloses that screw holes are paired. Mazur' s Figures 12A and 12H (annotated) are reproduced below to illustrate this: 400- ~ FIG. 12A FIG., 12H 7 Appeal2017-008208 Application 13/793,044 Figure 12A shows a curved, hollow, tubular bone-fixation hub having holes for screws and Figure 12H shows a similar hub implanted in a bone and having screws in its holes and in the bone. Mazur explains, "FIGS. 12G-121 illustrate an example [ of] how bone screws 420, 422, 424 may be inserted through hub 400' ( which is similar to hub 400" of Figure 11 C). Mazur ,r 99. Figure 12A above-left is annotated with red, double ended arrows to show how the bone screw holes are paired in such a way that the channels for bone screws are oriented substantially perpendicularly to the central axis of the hub, but for the channel between the open proximal threaded end of the hub 402 and its exit opening 418, which together provide the most proximal screw openings and the most proximal screw channel of the device. All of this is well illustrated by Figure 12H above-right, which shows the screws inserted into such screw opening and channels, with the channels highlighted with similar red, double ended arrows. As noted with the bare holes of Figure 1 lC, Figures 12A and 12H show a screw inserted through the proximal end of the device exits through the nearby hole that is closer to the proximal end of the device than the other screw holes, whether entry or exit. [U]nless a [prior art] reference discloses within the four comers of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. Â§ 102. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Here, without resorting to speculation, Mazur's disclosure does not support all the limitations of claim 1 and, for the reasons discussed above, we 8 Appeal2017-008208 Application 13/793,044 conclude the Examiner has not established a prima facie case that claim 1 is anticipated by the reference. CLAIM8 Regarding independent claim 8, Appellants argue that the structure identified by the Examiner's rejection as the claimed head portion of the claimed curvilinear body elongate along a central axis of the styloid intramedullary fixation nail is a mesh structure, which the skilled artisan would recognize would not have the structural characteristics necessary to serve as a fixation device. Specifically, Appellants argue: With respect to independent claim 8, it is respectfully submitted that the mesh ofMazur's Fig. 18B does not constitute an intramedullary nail or intramedullary fixation device, as required by independent claim 8. Those skilled in the art will recognize that meshes do not have the physical strength or support necessary for fixation, especially intramedullary fixation where the implant will bear a load in maintaining stability of bone fragments during the healing process. Rather, messhes [sic] are used as substrates for bone growth. While the mesh is created to avoid impeding the passage of bone screws used with the hub 650, the Examiner has failed to show a device capable of intramedullary fixation that teaches, describes or suggests each element and limitation of claim 8. Appeal Br. 8. Upon review of the Mazur reference, this argument is not persuasive. Regarding the mesh structure at issue, Mazur discloses: FIGS. 18A and 18B show another exemplary embodiment of a bone fixation hub 650. Hub 650 has at least a portion that is fabricated from a mesh structure, forming a plurality of diamond or other shaped apertures 652. Apertures 652 may be configured with dimensions smaller than the major diameter of the threads of the bone screws to be used. Aperture dimensions may even 9 Appeal2017-008208 Application 13/793,044 be smaller than the minor thread diameter, such that the apertures are stretched and/ or deformed as the screw enters the aperture, thereby providing an increased ability to hold the screws in place. The use of a mesh hub 650 may reduce the amount or possibility of debris being formed and released inside the body during in vivo screw hole formation. Mazur ,r 115. This disclosure is clear that the mesh structure 650 is "a bone fixation hub." On its face, this phrase indicates that the mesh hub is structurally sufficient to fix bone. The structures "400" and "400"' shown in Mazur's Figures 12A and 12H are also hubs, like the mesh shown in Figure 18A. Each of these hubs is a fixation structure. Appellants have not argued the hubs of the embodiments shown in Mazur' s Figures 11 A-12I, also referenced by the Examiner as disclosing claim elements, "do not have the physical strength or support necessary for fixation," and we conclude the disclosure of Mazur supports that they do. See, e.g., id. ,r 63 ("The device 100 is used for fixation of fractures of the proximal or distal end of long bones such as intracapsular, intertrochanteric, intercervical, supracondular, or condular fractures of the femur .... "), ,r 92. Being intended for the same purpose, we conclude the mesh also has such a structure. "[A] prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant .... " In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). We presume the bone fixation hubs disclosed by Mazur, including the mesh bone fixation hub of Figure 18A, can do what Mazur teaches they do. For the reasons above, we are unpersuaded by Appellants' arguments that the Examiner has erred in presenting a prima facie case that claim 8 is 10 Appeal2017-008208 Application 13/793,044 anticipated by Mazur or that the preponderance of the evidence on appeal does not support such a case for anticipation. Therefore, we affirm the rejection as to this claim. As noted above, Appellants do not argue the dependent claims separately and so they fall with claim 8. SUMMARY The anticipation rejection is affirmed as to claims 8-13 and 23; it is reversed as to claims 1-7, 21, and 22. No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. Â§ 1.13 6( a )(1 )(iv). AFFIRMED-IN-PART 11