Ex Parte Schlienger et alDownload PDFPatent Trial and Appeal BoardJun 3, 201511343857 (P.T.A.B. Jun. 3, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/343,857 01/30/2006 Andre Schlienger 10139/11302 8296 76960 7590 06/04/2015 Fay Kaplun & Marcin, LLP 150 Broadway, suite 702 New York, NY 10038 EXAMINER COTRONEO, STEVEN J ART UNIT PAPER NUMBER 3733 MAIL DATE DELIVERY MODE 06/04/2015 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 ANDRE SCHLIENGER, DANKWARD HONTZSCH, MARKUS BUETTLER, and PETER SENN 1 __________ Appeal 2012-010195 Application 11/343,857 Technology Center 3700 __________ Before ERIC B. GRIMES, CHRISTOPHER G. PAULRAJ, and AMANDA F. WIEKER, Administrative Patent Judges. WIEKER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an intramedullary nail, which have been rejected as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellants, the Real Party in Interest is Synthes USA, LLC (App. Br. 2). Appeal 2012-010195 Application 11/343,857 2 STATEMENT OF THE CASE Intramedullary nails are locked in place by a locking screw placed in a transverse borehole of the nail (Spec. ¶ 3). Often “the outside diameter of the screw is underdimensioned such that it will be less than the diameter of the transverse bore,” allowing “the locking screw to enter into and pass through the transverse bore despite [any] aiming error” (id.). “While some play or clearance is essential to guarantee the usefulness of the locking for surgeons, in the case of some indications (e.g. in the case of metaphysial fragments) it is clinically undesirable” (id. ¶ 4). The present invention, therefore, provides “an intramedullary nail, where the clearance between the nail and the locking screw can be eliminated without risk, and where an improved holding force as well as an improved guiding effect can be achieved between the locking screw and the medullary nail” (id. ¶ 7). Claims 1–19 are on appeal (App. Br. 10–13). Claim 1 is illustrative and reads as follows: 1. An intramedullary nail comprising: a nail body having a central longitudinal axis, an outer wall surrounding a longitudinal bore and defining an inner wall surface, and a transverse opening through the outer wall, the transverse opening having a central axis and a cross-sectional profile F and configured for receiving a bone fixation element; and a longitudinal component disposed within the longitudinal bore and extending partially into the transverse opening to abut against a bone fixation element inserted through the transverse opening without being penetrated by the bone fixation element. (id. at 10 (emphasis added)). Independent claims 17 and 18 contain language similar to that emphasized above (id. at 12–13). Appeal 2012-010195 Application 11/343,857 3 The claims stand rejected as follows: Claims 1–4 and 6–19 under 35 U.S.C. § 102(e) as anticipated by Hover 2 (Ans. 2–4). Claim 5 under 35 U.S.C. § 103(a) as obvious over Hover (id. at 4–5). DISCUSSION Issue The Examiner has rejected claims 1–19 as anticipated by, or as obvious in view of, Hover. The Examiner finds that Hover discloses, inter alia, an intramedullary nail with a transverse opening that receives a bone fixation element (screw) (Ans. 2). The Examiner finds that Hover discloses a longitudinal component (346) disposed near the transverse opening, wherein “[t]he screw does not penetrate the insert (fig 23 screw is next to the insert and in alternative col. 20, ll. 48-55, the bone fastener is placed between [two] spacers… therefor[e] it is not penetrating either spacer)” (id. at 2–3). Appellants contend that “Hover discloses an insert positioned within a transverse window extending through an intramedullary nail such that a bone fixation element inserted through the window must penetrate the insert” (App. Br. 5). The issue presented is whether Hover discloses a longitudinal component that is not penetrated by a bone fixation element. 2 Hover et al., US 6,783,529 B2, issued Aug. 31, 2004. Appeal 2012-010195 Application 11/343,857 4 Principles of Law “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Analysis We conclude that the Examiner has not established that Hover’s longitudinal component is not penetrated by the bone fixation element. Specifically, we find that Hover discloses a spacer 46/346 (see, e.g., Hover at col. 6, ll. 57–59; col. 15, ll. 38–40). As shown in Figure 18, Hover discloses a bone screw 48 extending through spacer 46, to secure the nail to the bone (id. at col. 4, ll. 45–46; col. 7, ll. 34–41). Indeed, Hover specifies that “the spacer 46 spaces the bone fastener 48 relative to the nail structure 22 . . . . Force is transmitted between the nail structure 22 and the bone fastener 48 primarily as a compressive load on a portion of the spacer 46” (id. at col. 7, ll. 35–41). Over time, Hover discloses that the spacer will be resorbed by the body “until resorption to the point where the [spacer] material will no longer support a load” and “all compressive stresses placed on the bone [will then be] carried across the fracture site 66 rather than by the nail 20” (id. at col. 7, ll. 55–58; col. 17, ll. 58–59). To shift the compressive stress and load from spacer 46 and bone fastener 48 to the fracture site, it appears that the bone fastener must extend through the spacer 46/346 (as shown in Hover’s Figures 18–22 and 24, and as described with respect to Hover’s Figure 23) so that the spacer will bear that force prior to resorption of the spacer material. We address the Examiner’s findings below. Appeal 2012-010195 Application 11/343,857 5 First, the Examiner finds that Hover’s Figure 23 illustrates that bone screw 48 is positioned next to insert 46, but is not penetrating it (Ans. 3). We do not agree with the Examiner’s finding. Regarding Figure 23, Hover discloses that “the width of the two windows 44 is preferably greater than the width of the bone fastener 48. . . . [which] permits some transverse displacement 74 of the bone screw” (Hover at col. 20, ll. 1–4). But regardless of its transverse placement, Hover specifies that the spacer “is drilled in-situ or the bone fastener 48 used opens its own hole through the spacer 46” (id. at col. 20, ll. 9–11). Therefore, whether the bone fastener is placed in a drilled hole or whether the bone fastener itself forms the hole, Hover’s arrangement requires that the bone fastener penetrate the spacer. This is consistent with Hover’s disclosed purpose that the bioresorbable spacer varies the amount of force that is borne by the fracture site over time (see, e.g., col. 6, l. 61–col. 7, l. 64; col. 17, ll. 33–59). Second, the Examiner finds that “the bone fastener is placed between [two] spacers… therefor[e] it is not penetrating either spacer,” citing column 20 at lines 48–55 (Ans. 3). We do not agree. The cited portion of Hover discloses that “the spacer(s) 46 may be formed of two or more distinct bioresorbable materials. . . . [and] [t]he bone fastener 48 may be positioned in the dynamization window 44 between a proximal spacer portion of one material and a distal spacer portion of a second material” (Hover at col. 20, ll. 44–55). However, as noted by Appellants, “Hover clearly indicates that the proximal and distal spacer portions form a single unitary spacer 46” (App. Br. 6; see Hover at col. 20, ll. 47–55). Therefore, this portion of Appeal 2012-010195 Application 11/343,857 6 Hover demonstrates only that the bone fixation element penetrates the spacer between two adjacent portions of different materials. Finally, in the Response to Argument section of the Examiner’s Answer, the Examiner finds that Hover discloses: that the longitudinal component (or spacer 46) does not need to extend the full width of the window. . . . [and] disclose[s] that force transmitted through the component can be in shear. For shear force to happen as opposed to compression and tension the fixation element must be aligned next [to] the component without penetrating it (i.e. not being located in a channel or hole of the component which would lead to compression of tensile forces) and just abutting a side of the component. (Ans. 5, citing Hover at col. 8, ll. 14–20). We agree with Appellants that the Examiner’s conclusion is speculative (Reply Br. 4). The Examiner has not established that the mere transmission of shear forces necessarily requires that the bone fixation element is “aligned next [to] the component without penetrating it.” See Akamai Techs., Inc. v. Cable & Wireless Internet Servs., Inc., 344 F.3d 1186, 1192 (Fed. Cir. 2003) (“A claim limitation is inherent in the prior art if it is necessarily present in the prior art, not merely probably or possibly present.”). Conclusion of Law The evidence of record does not support the Examiner’s finding that Hover discloses a longitudinal component that is not penetrated by a bone fixation element, as required by independent claims 1, 17, and 18. We reverse the rejection of these independent claims. The rejections of dependent claims 2–16 and 19 are also reversed. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988) (“Dependent claims are nonobvious under Appeal 2012-010195 Application 11/343,857 7 section 103 if the independent claims from which they depend are nonobvious.”). SUMMARY We reverse the rejections of claims 1–19. REVERSED cda Copy with citationCopy as parenthetical citation