Ex Parte Schmieding et alDownload PDFPatent Trial and Appeal BoardSep 23, 201311155742 (P.T.A.B. Sep. 23, 2013) 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. 11/155,742 06/20/2005 Reinhold Schmieding A8130.0425/P425 3535 24998 7590 09/23/2013 DICKSTEIN SHAPIRO LLP 1825 EYE STREET NW Washington, DC 20006-5403 EXAMINER MASHACK, MARK F ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 09/23/2013 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 REINHOLD SCHMIEDING, R.D. GRAFTON, PETER J. DREYFUSS, and STEPHEN S. BURKHART __________ Appeal 2012-002999 Application 11/155,742 Technology Center 3700 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a surgical method. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Arthrex, Inc. (See App. Br. 2.) Appeal 2012-002999 Application 11/155,742 2 Statement of the Case Background “The present invention includes soft-tissue connectors, anchoring devices (anchors), instrumentation, and related surgical techniques and constructs used to secure suture to bone without the need to tie a knot in suture” (Spec. 2 ¶ 0005). The Claims Claims 9, 12, and 13 are on appeal. Claim 9 is representative and reads as follows: 9. A surgical method comprising: forming a socket in bone; attaching a soft tissue connector formed as a flat narrow tape to soft tissue by looping the flat narrow soft-tissue connector through soft tissue and then through itself, to thereby form a flat, narrow connector limb attached to the soft tissue, wherein the step of looping the flat narrow soft-tissue connector through itself comprises passing the soft tissue connector through an eye of the soft tissue connector; extending the connector limb over the opening of the socket; engaging and urging the connector limb into the socket with the tip of an instrument; and securing the connector limb within the socket by interference fixation by installing a bone anchor in the socket. The issue The Examiner rejected claims 9, 12, and 13 under 35 U.S.C. § 103(a) as obvious over Thal2 and Lizardi3 (Ans. 4-6). The Examiner finds that Thal teaches a method comprising “forming a socket in bone (Fig 4-5); attaching a soft tissue connecter 26 formed as a flat 2 Thal, R., 5,569,306, issued Oct. 29, 1996. 3 Lizardi, J., 5,782,864, issued Jul. 21, 1998. Appeal 2012-002999 Application 11/155,742 3 narrow tape to soft tissue by looping the flat narrow tape through soft tissue and then through an eye 28 (Column 3, Lines 11-16 and Fig 4-5); the connector limb is extended over the opening of the socket (Fig 4-5)” (Ans. 4). The Examiner finds that Thal “does not explicitly disclose of the ‘engaging and urging’ step, ‘the bone anchor [being] cannulated’, or ‘the interference fixation’” (id. at 5). The Examiner finds that Lizardi teaches “a similar method of securing a suture anchor into bone comprising urging the bone anchor with the tip of an instrument 20 and the anchor is cannulated 38 in order to engage the instrument” (id.). The Examiner finds it obvious to provide the instrument and the cannulated anchor as taught by Lizardi to the method of Thal. One of ordinary skill in the art would understand the advantages of providing the driver and the cannulated anchor as taught by Lizardi to secure the anchor of Thal would include facilitating the engaging and rotating in “the tight space encountered during endoscopic surgery” (id.). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Thal and Lizardi render claim 9 obvious? Findings of Fact 1. Thal teaches “a process for reattachment of tissue to bone mass. Bone mass 42 has a slot or hole 44 wherein a hollow anchoring sleeve 46 has been inserted” (Thal, col. 6, ll. 20-23). Appeal 2012-002999 Application 11/155,742 4 2. Thal teaches that: The spike or plug member is inserted during an open or endoscopic procedure, or the like, through the soft tissue and its piercing or pointed end is then threaded through the loop portion formed in the suture material prior to its ultimate insertion into the anchoring sleeve to facilitate a secure mating. (Thal, col. 3, ll. 11-16.) 3. Figure 13 of Thal is reproduced below: “FIG. 13 illustrates the embodiment of FIG. 12 in conjunction with a bone mass and tissue during surgical reattachment” (Thal, col. 4, ll. 37-39). 4. Thal teaches that when “performing a procedure, loop portion 156 is pulled through soft tissue 160. Once the loop portion 156 has been pulled through the soft tissue 160, the spike/anchor means 152 is inserted through the loop portion 156 and directly into bone mass 170 for attachment of tissue 160 to bone mass 170” (Thal, col. 8, ll. 32-37). Appeal 2012-002999 Application 11/155,742 5 5. Thal teaches that the “exterior of the spike or plug member 12 may be ribbed or threaded 24 . . . or may be beaded or expandable to allow for a secure tight fit with the inner hollow cylinder of the anchoring sleeve” (Thal, col. 5, l. 65 to col. 6, l. 2). 6. Thal teaches that The spike or plug member may take the form of any structure and preferably has an exterior which is ribbed, threaded, beaded, expandable or smooth. The diameter of thickness of the member is preferably equal to or incrementally less than the entire diameter of the hollow anchoring sleeve for a secure fit. In situations where ribs, threads, beads, or the like, are utilized on the spike member, the diameter of the member with protrusions may initially exceed the inner diameters of the hollow anchoring sleeve and would deform upon insertion. (Thal, col. 7, ll. 21-30.) 7. Thal teaches that “the suture element 88 may be made of any acceptable surgical suture material and in addition is lengthened based upon thickness and need requirements” (Thal, col. 6, ll. 55-57). 8. Lizardi teaches that the “first suture loop 14 may be constructed from thread suitable for use as a suture. A variety of suture materials are well known to those of ordinary skill in the art. Exemplary materials include braided polyester and polydioxanone (PDS)” (Lizardi, col. 4, ll. 5-9). 9. The Specification teaches that the “tape material can be formed of suture can be configured as a webbing which is manufactured by weaving or braiding” (Spec. 2 ¶ 0005). Appeal 2012-002999 Application 11/155,742 6 10. Lizardi teaches “a system 10 for anchoring tissue to bone . . . . The system may also include an anchor insertion tool 20” (Lizardi, col. 3, ll. 6-13). 11. Lizardi teaches that the “two free ends of the suture thread are then entered into the suture loop closure 44 and the suture loop closure 44 is crimped to retain the ends of the suture thread and form the second suture loop 18” (Lizardi, col. 4, ll. 51-54). 12. Figure 6 of the Specification is reproduced below: “FIG. 6 illustrates [the] use of an alternative anchoring device having a pointed tip or sharp spike for engaging soft-tissue connector by penetrating the tape and preventing slip” (Spec. 4 ¶ 00016). Principles of Law “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). Appeal 2012-002999 Application 11/155,742 7 “‘[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Analysis Thal teaches a surgical method for attaching tissue to bone (FF 3) in which the loop of a suture material is pulled through soft tissue (FF 4, 7) following a spike is threaded through a loop portion (FF 2) and then inserted into an anchoring sleeve in bone (FF 4). Lizardi teaches braided suture materials (FF 8) as well as the use of an anchor insertion tool (FF 10) and crimping the suture material onto a suture loop closure (FF 11). Even if we agree with the Examiner that the insertion of the suture through a loop is equivalent to “passing the soft tissue connector through an eye of the soft tissue connector” as required by claim 9, we cannot agree that either Thal or Lizardi teach or suggest the steps of “engaging and urging the connector limb into the socket with the tip of an instrument; and securing the connector limb within the socket by interference fixation by installing a bone anchor in the socket” as required by claim 9. That is, claim 9 requires formation of a narrow “connector limb” from the “flat narrow tape” looped through itself. Consequently, the “connector limb” must be composed of the tape material, and not a separate anchor of the sort disclosed in Figure 13 of Thal. More importantly, claim 9 requires an order of operations where the “connector limb” composed of the looped tape is first inserted into the Appeal 2012-002999 Application 11/155,742 8 socket in the bone (using an instrument), after which a “bone anchor” is placed on top of the “connector limb” located within the socket. This results in embedding a portion of the “connector limb” underneath the bone anchor, which is secured into the socket by an interference fit between the “connector limb,” bone anchor, and bone socket. Neither Thal nor Lizardi teach placement of the “connector limb” or looped suture into the socket prior to insertion of the bone anchor. Instead, these references place the bone anchor, attached to a looped suture, into the socket, but the looped suture will not be embedded underneath the bone anchor as required by claim 9 using the method of either Thal or Lizardi. This result is most clearly shown in Figure 6 of the Specification (FF 12), where the “connector limb” is clearly located beneath the anchor pin (FF 12). The Examiner finds that there “is no claim language requiring that the connector limb is further engaged by a bone anchor after the limb is extended over the socket” (Ans. 6). We disagree. The final two steps of claim 9 require placement of the connector limb into the socket, following which the connector limb is fixed by interference fixation using a bone anchor. This is an express requirement for an interaction between the bone anchor and the connector limb. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Thal and Lizardi render claim 9 obvious. Appeal 2012-002999 Application 11/155,742 9 SUMMARY We reverse the rejection of claims 9, 12, and 13 under 35 U.S.C. § 103(a) as obvious over Thal and Lizardi. REVERSED cdc Copy with citationCopy as parenthetical citation