Ex Parte Wheatley et alDownload PDFPatent Trial and Appeal BoardJun 21, 201310512964 (P.T.A.B. Jun. 21, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARGARET A. WHEATLEY and ARI D. BROOKS1 __________ Appeal 2011-011762 Application 10/512,964 Technology Center 3700 __________ Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a tissue joining device and method. The Examiner has rejected the claims as anticipated or obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Drexel University (App. Br. 1). Appeal 2011-011762 Application 10/512,964 2 STATEMENT OF THE CASE Claims 1, 2, and 5-14 are pending and on appeal (App. Br. 2). Claims 6, 7, 12, and 13 are representative and read as follows: 6. A tissue joining device comprising a closing means of one or more components which bend, interconnect or attract magnetically so that there is a variable gap size between the bent, interconnected or magnetically attracted component or components, the closing means, comprising a rivet, comprising a head portion situated adjacent to a tubular portion, a lumen passing through the head and tubular portions, and ratchetable spikes situated outwardly around the tubular portion, and a ratchet nut into which the tubular portion is capable of being inserted, the ratchetable spikes capable of operating with the ratchet nut to give rise to a variable ratchetable gap size in discrete steps between the head portion of the rivet and the ratchet nut, and wherein the tissue joining device is capable of joining tissue at an anastomosis site and sized to fit within a vessel or organ having a lumen diameter of about 10 mm or less. 7. The tissue joining device of claim 6 wherein at least one of the components is loaded with a bioactive agent. 12. A method for joining tissue at an anastomosis site or surgical site within a vessel or organ having a lumen diameter of about 10 mm or less, said method comprising contacting said tissue using a tissue joining device comprising a closing means of one or more components which bend, interconnect or attract magnetically so that there is a variable gap size between the bent, interconnected or magnetically attracted component or components, the closing means, comprising a rivet, comprising a head portion situated adjacent to a tubular portion, a lumen passing through the head and tubular portions, and ratchetable spikes situated outwardly around the tubular portion, and a ratchet nut into which the tubular portion is capable of being inserted, the ratchetable spikes capable of operating with the ratchet nut to give rise to a variable ratchetable gap size in discrete steps between the head portion of the rivet and the ratchet nut. Appeal 2011-011762 Application 10/512,964 3 13. The method of claim 12 wherein at least one of said components is loaded with a bioactive agent. Claims 6, 12, and 14 stand rejected under 35 U.S.C. § 102(b) as anticipated by Kaster (US 4,366,819, Jan. 4, 1983) (Ans. 3). Claims 1, 2, 5, 7-11, and 13 stand rejected under 35 U.S.C. § 103(a) as obvious over Kaster in view of Nash et al. (US 6,063,114, May 16, 2000) (Ans. 4). ISSUES With regard to both grounds of rejections, Appellants raise the following issues: Does Kaster disclose a rivet comprising a head portion situated adjacent to a tubular portion? Does Kaster disclose the tissue joining method recited in claim 12? ANTICIPATION In rejecting claims 6 and 12, inter alia, the Examiner finds: Kaster discloses . . . a tissue joining device and a method for joining tissues at an anastomotic site or surgical site within a vessel or organ, the method including contacting tissue using the tissue joining device, which comprises closing means, where the closing means includes a rivet (12) with a head portion (12b or 12c) adjacent to a tubular portion, a lumen passing through the head and tubular portions, and ratchetable spikes (at 12e) situated around the tubular portion; and a ratchet nut (18) into which the tubular portion is capable of being inserted, the ratchetable spikes capable of operating with the ratchet nut as claimed; where the joining device is capable of joining tissue at an anastomosis site and is sized to fit within a vessel or organ with a lumen diameter of about 10 mm or less. Appeal 2011-011762 Application 10/512,964 4 (Ans. 3-4.) The Examiner also finds, “assuming arguendo, that element 12b or 12c cannot be a head portion, then element 14 may be deemed a head portion having a diameter greater than tubular portion 12, and elements 14 and 12 would comprise a two-part rivet” (id. at 6). Analysis We agree with the Examiner that Kaster’s “element 14 may be deemed a head portion having a diameter greater than tubular portion 12, and elements 14 and 12 would comprise a two-part rivet” (Ans. 6). Appellants argue “that the language ‘a rivet’ when combined with ‘a head portion’ which is ‘situated adjacent to a tubular portion’, when read by one skilled in the art would be interpreted to be a single piece construction” (Reply Br. 2). However, Appellants have not provided any evidence to support this position. Therefore, we conclude that it was reasonable for the Examiner to interpret claims 6 and 12 to include a rivet of two-part construction. With regard to claim 12, Appellants additionally argue that the method “very clearly involves placing the device in contact with blood flow, a concept that the Kaster patent distinctly teaches away from” (Reply Br. 2). We are not persuaded. Kaster discloses that anastomotic fitting 10 “can be used to connect both biologic as well as synthetic vascular grafts to blood vessels” (Kaster, col. 10, ll. 42-44). In particular, Kaster discloses: The gauged end of the vein graft is passed through the tube 10. . . . The tubed/graft is ready to receive the ringflange 14. . . . Proper placement of the ringflange 14 occurs when the slit has returned to or near its pre-engagement relaxed width and the spikes 14f and 14g in both encircling rows engage the surface Appeal 2011-011762 Application 10/512,964 5 of the tube 12. . . . This assembly is now attached to the aortic wall. A hole having a diameter equal to or slightly larger but not more than one millimeter larger than the outside diameter of the tube is made in the predetermined place in the aortic wall. . . . Because blood is an excellent lubricant, and is readily accessible in the operative field, the ringflange 14 is wetted with blood to facilitate and ease its passage through the smaller diameter aortic wall hole. Grasping the tube near its out[f]low end, the peripheral edge of the ringflange is positioned at the center of the hole and angled substantially 30 degrees relative to the plane of the hole. The leading peripheral edge of the ringflange is then advanced into the hole and with a firm continuous twisting motion and is engaged into the aortic lumen. As a result, the free edge of the graft 20 may have to be adjusted and continuing, therefore, to grasp the outflow end 12f of the tube 12, the assembly is gently retracted until the ringflange 14 engages the inside of the aortic wall 22 causing the peripheral edge of the hole to bulge outward in response to the angulation of the aortic wall surface of the ringflange 14 as illustrated in FIG. 1. (Id. at col. 10, l. 59, to col. 11, l. 60.) Thus, Kaster discloses that at least the ringflange 14 is inside a blood vessel and therefore, to the extent required by claim 12, in contact with blood flow. As noted by Appellants, claim 12 is directed to “a method for ‘joining tissue at an anastomosis site or surgical site within a vessel or organ having a lumen diameter of about 10 mm or less’” (Reply Br. 1-2). However, Appellants have not adequately explained why Kaster fails to disclose this. In particular, it is not clear to us how this language, or any other language in claim 12, requires use of the device as a stent, as argued by Appellants (App. Br. 8). Appeal 2011-011762 Application 10/512,964 6 Conclusion The evidence supports the Examiner’s conclusion that Kaster discloses a rivet comprising a head portion situated adjacent to a tubular portion. We therefore affirm the anticipation rejection of claim 6. The evidence also supports the Examiner’s conclusion that Kaster discloses the tissue joining method recited in claim 12. We therefore affirm the anticipation rejection of claim 12. Claim 14 has not been argued separately and therefore falls with claim 12. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS In rejecting claims 7 and 13, inter alia, the Examiner relies on Kaster as discussed above (Ans. 4). In addition, the Examiner finds that “Kaster also discloses a disk (16) situated between the head portion (12b) of the rivet and the ratchet nut (18)” (id.). However, the Examiner acknowledges that “Kaster does not disclose that the disk or one of the components of the closing means is loaded with a bioactive agent” (id.). The Examiner relies on Nash for teaching “a tissue joining device and a method with the device for delivering bioactive agents to a surgical site, where the device and method comprises . . . components loaded with bioactive agents” (id. at 4-5). The Examiner concludes that it would have been obvious, “in view of Nash et al., to modify the tissue joining device and method of Kaster, so that it includes . . . bioactive agents” because the “addition of bioactive agents would enhance the therapeutic value of the joining device by aiding in the connection and healing of tissues or by preventing disease of the tissues” (id. at 5). Appeal 2011-011762 Application 10/512,964 7 Analysis Appellants traverse the obviousness rejection based on the argument that Kaster fails to teach a rivet comprising a head portion situated adjacent to a tubular portion and the failure of Nash to cure this defect (App. Br. 9- 10). However, for the reasons discussed above, we do not agree that Kaster is defective. Appellants also traverse the rejection of claim 13 based on the argument that Kaster fails to teach the method of claim 12, on which claim 13 depends (id. at 10). However, we are not persuaded by this argument for the reasons discussed above. Conclusion The evidence supports the Examiner’s conclusion that Kaster discloses a rivet comprising a head portion situated adjacent to a tubular portion. We therefore affirm the obviousness rejection of claim 7. Claims 1, 2, 5, and 8-11 have not been argued separately and therefore fall with claim 7. 37 C.F.R. § 41.37(c)(1)(vii). The evidence also supports the Examiner’s conclusion that Kaster discloses the tissue joining method recited in claim 12. We affirm the obviousness rejection of claim 13, which depends from claim 12. SUMMARY We affirm the anticipation rejection of claims 6, 12, and 14 and the obviousness rejection of claims 1, 2, 5, 7-11, and 13. Appeal 2011-011762 Application 10/512,964 8 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED lp Copy with citationCopy as parenthetical citation