Ex Parte Jahns et alDownload PDFBoard of Patent Appeals and InterferencesJul 19, 201211604932 (B.P.A.I. Jul. 19, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte SCOTT E. JAHNS, JAMES R. KEOGH, PAUL A. PIGNATO, CHRISTOPHER P. OLIG, KAREN P. MONTPETIT, CYNTHIA T. CLAGUE, RAYMOND W. USHER, PHILIP J. HAARSTAD, and GARY W. GUENST __________ Appeal 2011-004154 Application 11/604,932 Technology Center 3700 __________ Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a seal for an opening in a blood vessel. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-004154 Application 11/604,932 2 STATEMENT OF THE CASE The Specification discloses “devices that are capable of creating and sealing incisions in cardiac blood vessels in order to facilitate a medical procedure, such as an anastomosis, on a stopped or beating heart” (Spec. 1). Claims 31-33, 35, and 37-46 are on appeal. Claims 31 and 38 are representative and read as follows: 31. A seal for temporarily sealing an opening in a blood vessel comprising: a seal member having an inflatable chamber with a proximal portion and a distal portion, the seal member having a collapsed configuration and an inflated configuration wherein the distal portion of the seal member in the inflated configuration is configured to extend into and include a continuous surface across the opening of the blood vessel; a shaft coupled to the seal member, the shaft having a shaft inner lumen fluidly connected to the inflatable chamber at the proximal portion for adding or removing fluid from the inflatable chamber; wherein the seal member comprises one or more ribs wherein at least one rib comprises a rib inner lumen fluidly connected to the shaft inner lumen. 38. A seal for temporarily sealing an opening in a blood vessel comprising: a plurality of seal members coupled to a delivery shaft having an axis, wherein the seal members are configurable into a delivery configuration for passage through the opening in the blood vessel and a sealing configuration for sealing the opening in the blood vessel such that the plurality of the seal members are disposed in an interior of the blood vessel, wherein each of the plurality of the seal members covers a portion of the opening and are radially disposed from each other about the axis of the delivery shaft in the sealing configuration, and a hinge for moving the seal members relative to the shaft. Appeal 2011-004154 Application 11/604,932 3 The claims stand rejected as follows: • Claims 31, 33, 35 and 37 under 35 U.S.C. §103(a) in view of Rutner;1 • Claims 32 under 35 U.S.C. §103(a) in view of Rutner and Bander;2 • Claims 38 and 40-46 under 35 U.S.C. § 102(a) in view of Golden;3 and • Claims 39 under 35 U.S.C. §103(a) in view of Golden and Borst.4 I. The Examiner has rejected claims 31, 33, 35 and 37 as obvious in view of Rutner, and has rejected claim 32 as obvious in view of Rutner and Bander. The same issue is dispositive for both of these rejections. The Examiner finds that Rutner “discloses a seal member (22) having an inflatable chamber … having a collapsed configuration (Figure 1) and an inflated configuration (… Figure 3)” (Answer 4), and that the “distal portion of the seal chamber in the inflated chamber is capable of extending into a vessel and providing a continuous surface across the opening of a blood vessel” (id. at 4-5). The Examiner finds that Rutner “discloses a shaft (11) coupled to the seal member (22)” (id. at 5). Appellants contend that Rutner does not teach or makes obvious a seal member “configured to extend into and include a continuous surface across the opening of the blood vessel,” as required by claim 31 (Appeal Br. 7). 1 Rutner et al., US 6,254,570 B1, July 3, 2001. 2 Bander, US 6,299,598 B1, Oct. 9, 2001. 3 Golden et al., Patent Application Publication US 2004/0102797 A1, May 27, 2004 (filed Nov. 18, 2003). 4 Borst et al., US 6,395,015 B1, May 28, 2002. App App App of th [and Rutn The acro wou a ves surfa other cont expl open dista surfa drain in a p eal 2011-0 lication 11 ellants arg e elongate have] a to er’s “tubu hole in the ss an open ld not look sel sealing The Exa ce becaus , by circli inuous sur We agre ained how ing in a bl l portion t ce across age cathet atient” (R 04154 /604,932 ue that Ru d tubular m roidal or d lar membe torus prev ing” (id.). to the tea device” ( miner resp e a line can ng the sha face if use e with App Rutner wo ood vessel hat “is con the openin er with a b utner, col tner’s ball ember pr oughnut-l r 11 is ext ents the to Appellant chings of a id. at 9). onds that be drawn ft, and bec d on its sid ellants th uld have m that inclu figured to g of the bl ack-up re . 1, ll. 12-1 4 oons “are p oximal to ike shape” ended thou rus from p s also argu retention Rutner’s d from one ause the R e (Answe at the Exam ade obvi des an infl extend int ood vesse tention me 3). Figur ositioned external d (id. at 8). gh [sic] a roviding e that “on member f evice prov side of th utner devi r 7). iner has ous a seal atable sea o and incl l.” Rutner mber for r e 3 of Rutn on the out rainage po Appellan hole in th a continuo e skilled i or drainag ides a con e doughnu ce could p not adequa for sealing l member ude a cont discloses etaining th er is show er surface rt 15 … ts argue e torus … us surface n the art e to create tinuous t to the rovide a tely an with a inuous “a e catheter n below: Appeal 2011-004154 Application 11/604,932 5 Figure 3 shows a “longitudinally sectioned view of the distal portion of elongated tubular member 11 of drainage catheter 10” (id. at col. 4, ll. 59- 61). Rutner discloses that “first and second retention balloons 20 and 22 are shown in an expanded state and attached to the outer surface of elongated tubular member 11 just proximal side drainage port 15” (id. at col. 4, ll. 61-66). We agree with Appellants that the balloon retention members of Rutner do not provide “a continuous surface across the opening of the blood vessel” because the surface of the balloons is interrupted by the tubular member that protrudes from them. We also agree with Appellants that the Examiner has not adequately explained why of one of skill in the art would look to a drainage catheter, or would modify a drainage catheter, to arrive a device that is capable of sealing a blood vessel. Even if the device is used on its side, as suggested by the Examiner, the Examiner has not adequately explained how the balloons of Rutner are sized or otherwise configured to extend into the opening of a blood vessel. Thus, we reverse the obviousness rejection of independent claim 31 and dependent claims 33, 35 and 37. With respect to the rejection of claim 32, the Examiner relies on Rutner as discussed above, and relies on Bander only to supply dependent claim limitations (Answer 5). Thus, we also reverse this rejection. II. The Examiner has rejected claims 38 and 40-46 as anticipated by Golden. The Examiner has also rejected claim 39 as obvious in view of Golden and Borst. The same issue is dispositive for both of these rejections. Appeal 2011-004154 Application 11/604,932 6 The Examiner finds that Golden “discloses a plurality of seal members (702) coupled to a delivery shaft (727) that have a delivery configuration (Figure 16a) and a sealing configuration (Figure 16b)” (Answer 4). The Examiner find that the “joint between shaft (727) and the seal members (702) is flexible and the seal members move relative to this joint, reading on the definition of a hinge” (id.), because the “Merriam- Webster dictionary defines a hinge as: ‘a jointed or flexible device on which a door, lid, or other swinging part turns’” (id.).5 The Examiner finds that the Specification “does not provide any further description that distinguishes over this definition” (id.). Appellants contend that “the examples in Figures 16a and 16b … make clear that there is no hinge between the seal members 702 and the delivery shaft 727 as required in claim 38” (Appeal Br. 11) and that “there is no teaching in the Golden Publication that a hinge is included between the seal members 702 and the delivery shaft 727” (id.). The Examiner responds that the Specification does not “state that the hinge is a separate device … [and] Figure 20, element 870 does not show a separate hinge … [or] anything besides a bend where the seal members move relative to the shaft” (Answer 8). We agree with Appellants that the Examiner has not adequately shown that Golden discloses a seal that comprises “a hinge for moving … seal members relative to the shaft.” Golden discloses an “apparatus … for performing an anastomosis” (Golden 1, ¶ 0002) that comprises, among other 5 The Examiner cites “http://www.merriam-webster.com/dictionary/hinge” as the source of the above definition (Answer 4). App App thing open is ad wall Figu Figu a rad ¶¶ 00 expa [726 restr expa wall mem shaft mov We a show eal 2011-0 lication 11 s, “a tubu ing in a ve vanced wi in order to res 16A an res 16A an ially expa 49-0050) nded to oc ] is withdr aint is rem nd outwar ” (id. at 6- Claim 3 bers relati (727) and e relative t gree with n that Go 04154 /604,932 lar membe ssel wall” thin the tu substanti d 16B of d 16B sho ndable me . Figure 1 clude the awn” (id. oved, the b dly to form 7, ¶ 0100) 8 requires, ve to the s the seal m o this join Appellant lden’s dev r having a (id. at 2, ¶ bular mem ally occlud Golden are w section mber com 6B shows opening in at 3, ¶ 005 ristles (70 an area o . among oth haft.” The embers (7 t, reading s, howeve ice include 7 n end with 0016), an ber throug e such op shown be al views o prising a p the “plura the vesse 0). Golde 2) turn in f hemosta er things, Examine 02) is flex on the defi r, that the E s a flexibl an edge a d “an occ h the open ening” (id low: f an “anast lurality of lity of bris l wall after n discloses to their me sis at the o “a hinge f r find that ible and th nition of a xaminer e joint bet dapted to lusion mem ing in the . at 2, ¶ 00 omosis de bristles” ( tles radiall the outer that, “[a] mory shap pening of or moving the “joint e seal me hinge” (A has not ad ween the s form an ber [that] vessel 17). vice, with id. at 3, y cylinder s the e and the vessel the seal between mbers nswer 4). equately haft and Appeal 2011-004154 Application 11/604,932 8 bristles (seal members). Golden discloses that the bristles are made of a shape memory material that resumes its memory shape upon the removal of restraint. Thus, Golden suggests that the bristles bend along the length of the wire as they resume their memory shape, not that they bend because of a flexible joint at the point where they join the shaft. Because the Examiner has not shown that Golden discloses every limitation of claim 38, the anticipation rejection of claim 38 and of dependent claims 40-46 is reversed. With respect to the rejection of claim 39, the Examiner relies on Golden as discussed above, and relies on Borst only to supply dependent claim limitations (Answer 6). Thus, we also reverse this rejection. SUMMARY We reverse the rejection of claims 38 and 40-46 under 35 U.S.C. § 102(a). We also reverse the rejection of claims 31, 32, 33, 35, 37 and 39 under 35 U.S.C. §103(a). REVERSED lp Copy with citationCopy as parenthetical citation