Ex Parte Vongphakdy et alDownload PDFPatent Trial and Appeal BoardApr 30, 201311433328 (P.T.A.B. Apr. 30, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KHAMLA VONGPHAKDY, HUISUN WANG, ADEL HASHW, and LIXIAO WANG __________ Appeal 2011-012742 Application 11/433,328 Technology Center 3700 __________ Before DONALD E. ADAMS, ERIC GRIMES, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to systems for delivering a self-expanding implant within a body lumen. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2011-012742 Application 11/433,328 2 STATEMENT OF THE CASE The invention concerns “a rapid exchange-type delivery system for a self-expandable implant such as a stent.” (Spec. [02].) In a rapid exchange- delivery system “the guidewire is slideably contained within a short distal length of the stent delivery system.” (Id. at [06].) Advantageously, the rapid exchange systems “use short (typically 170 cm) guidewires which can be handled by one operator,” avoiding the increased procedural cost and complexity involved with over-the-wire systems. (Id.) It is important in the rapid exchange systems for the stent delivery system “to slide easily over the guidewire so that the stent can be easily tracked over the guidewire to the intended deployment site. If the components of the stent delivery system are not properly aligned there can be friction against, or entanglement with, the guidewire.” (Id. at [07].) Claims 1, 6-12, 14-19, 21, 23-25, 27, 29, and 30 are on appeal. Independent claims 1, 12, and 21 are representative and read as follows: 1. A system for delivering a self-expanding implant within a body lumen comprising: a tubular catheter having proximal and distal ends and comprising an outer shaft member slidably disposed about an inner shaft member, the inner shaft member having a first interlock structure; a tubular self-expanding implant disposed intermediate the inner and outer shaft members, a proximal end of the implant having a second interlock structure configured to mate with the first interlock structure to maintain rotational alignment between the implant and the inner member; a guide wire lumen extending at least partially through the inner shaft member from a proximal opening to a distal opening in the inner shaft member and exiting the outer shaft member through a radial guide wire lumen opening of the outer shaft member at a location intermediate of the catheter proximal end and the proximal opening in the inner shaft member; and Appeal 2011-012742 Application 11/433,328 3 an alignment mechanism comprising a contact surface disposed about an inner circumference of the outer shaft member, said inner circumference being in frictional contact with at least a portion of the self-expanding stent to maintain rotational alignment of the outer shaft member relative to the inner shaft member, thereby maintaining alignment between the guide wire lumen and the guide wire lumen opening. 12. A system for delivering a medical device within a body lumen comprising: a tubular inner shaft member having a proximal end and a distal end and an inner shaft guide wire lumen radially offset from a center axis of the tubular inner shaft member and extending at least partially therethrough, and a guide wire extension tube extending proximally from the proximal end of the tubular inner shaft member; a tubular outer shaft member having a proximal end and a distal end and defining an outer shaft guide wire lumen extending at least partially therethrough and a guide wire opening disposed in a sidewall of the outer shaft member at a location proximal of the distal end of the outer shaft member, the outer shaft guide wire lumen being radially offset from a center axis of the tubular outer shaft member and slidably receiving the guide wire extension tube, the outer shaft member being slidably disposed about the inner shaft member; a push wire connected to the proximal end of the tubular inner shaft member for slidably moving the tubular inner shaft member in the tubular outer shaft member; and a self-expanding medical device disposed intermediate the inner and outer shaft members in a compressed configuration, a first end of the medical device having tab portions releasably coupled to an interlock mechanism disposed on the inner shaft member to maintain rotational alignment between the medical device and the inner shaft member, the compressed medical device being in friction contact with an inner surface of the outer shaft, the friction contact between the medical device and the outer shaft maintaining rotational alignment between the guide wire extension tube and the outer shaft guide wire lumen. 21. A system for delivering an implant, the system comprising: an inner member comprising an implant receiving portion, and a guidewire lumen extending through the inner member, and a guidewire lumen extension portion extending proximally from the guide wire lumen, Appeal 2011-012742 Application 11/433,328 4 the implant receiving portion being configured to releasably receive an implant and maintain rotational alignment between said implant and the inner member; an outer member comprising a port opening and a port opening extension portion disposed inside the outer member and slidably coupled to the guidewire lumen extension portion, the outer member disposed about the inner member and sized to provide friction contact with an implant releasably mounted on the inner member, said friction contact maintaining rotational alignment between the inner member and the outer member; and a push wire connected to the proximal end of the inner member for slidably moving the inner member in the outer member, wherein the offset guidewire lumen extension portion in cooperation with the port opening extension portion maintains rotational alignment between the outer member and the inner member. The Examiner rejected claims 1, 6-12, 14-19, 21, 23-25, 27, 29, and 30 under 35 U.S.C. § 103(a) as unpatentable over Lenker, 1 Thompson, 2 and Griffin. 3 OBVIOUSNESS The Examiner‟s position is that Lenker substantially disclosed a system for delivering a self-expanding implant within a body lumen, as claimed, except for disclosing (a) a radial guide wire lumen exiting the outer shaft member in a manner recited in the claims, and (b) the recited interlock structure. (Ans. 4-5.) The Examiner found that Griffin disclosed a catheter shaft having a side opening for the guidewire lumen. (Ans. 5.) The Examiner found that Griffin disclosed that its guidewire lumen opening allows for a rapid 1 US Patent No. 5,683,451 issued to Jay A. Lenker et al., Nov. 4, 1997. 2 Patent No. US 6,814,746 B2 issued to Paul J. Thompson et al., Nov. 9, 2004. 3 Patent Application Publication No. US 2008/0262506 A1 by Patrick Griffin et al., published Oct. 23, 2008. Appeal 2011-012742 Application 11/433,328 5 exchange arrangement that enables a catheter to be passed over a guidewire by a single user quickly and efficiently. (Id.) Therefore, according to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have modified the device of Lenker to include a side opening for the guidewire lumen, as taught by Griffin, to allow the device to be used for rapid exchange over the guidewire. (Id.) Additionally, the Examiner found that Thompson disclosed an interlock system which engages tabs on a stent to hold the stent on the placement guidewire even when a majority of the stent has been exposed by retraction of the sheath so that the stent may be recovered and correctly placed. (Id. at 5-6.) Therefore, according to the Examiner, it would have been obvious to modify the device of Lenker to include an interlock element on the inner shaft member and stent, as taught by Thompson, to allow for improved stent placement control. (Id. at 6.) Appellants contend that the combination of Lenker, Thompson and Griffin is improper because the combination: (a) would change the principle of operation of Lenker; (b) render Lenker unsatisfactory for its intended purpose; and (c) is taught away from by Lenker, Thompson and Griffin. (App. Br. 6, 13-17.) In particular, Appellants assert that “[m]odifying Lenker to include the type of interlock structure described in Thompson would entirely change the manner in which undesired movement of the Lenker graft 10 is restricted” because Lenker uses runners to restrain the graft via compression, while Thompson relies on its interlock structures to constrain movement. (App. Br. 13.) Appeal 2011-012742 Application 11/433,328 6 Initially, we note that Appellants do not assert that Lenker‟s runners would interfere with the function of interlock structures in a modified device. Rather, Appellants assert that the Examiner‟s modification would render Lenker‟s runners “entirely superfluous….” (Id.) We disagree. As the Examiner correctly explained, the proposed modification of Lenker maintains the functions of the runners because the runners would still (i) control the manner in which the stent expands, i.e., provide an intermediate step where the stent is held partially (rather than fully) expanded when the guide catheter is withdrawn, and (ii) prevent the prosthesis from invaginating the lumen surface, allowing the prosthesis to slide relative to the cover in response to a moderate distal force. (Ans. 8-9)(citing Lenker col. 7, ll. 36-39; col. 9, ll. 18-24; Figs. 2-3). Nor are we persuaded that Lenker and Thompson taught away from their combination or that one of ordinary skill would not have been motivated to combine Lenker and Thompson based upon Appellants‟ assertion that doing so would result in Lenker‟s runners being “entirely superfluous.” (See App. Br. 16.) Appellants assert that modifying Lenker to include Griffin‟s guidewire opening 6 “would render the Lenker device unsatisfactory for its intended purpose” because the modification “would likely disrupt the independent, relative sliding motion between the core shaft 44, the shaft 34, and the cover 32, potentially rendering the device inoperable.” (App. Br. 14-15.) Appellants base this contention on the fact that Lenker “relies upon a concentric, tri-shaft arrangement comprising the core shaft 44, the shaft 34 and the cover 32,” while “Griffin employs a simpler, dual-shaft arrangement….” (Id. at 14.) However, Appellants have not supported their contention with evidence that the Examiner‟s modification would have been Appeal 2011-012742 Application 11/433,328 7 beyond the skill in the art in view of Griffin. Moreover, the Examiner provided Andreas 4 as evidence that it was known for a three catheter system to be capable of having a guidewire lumen exit the shaft member via a port. (Ans. 9.) Thus, we are not persuaded by Appellants‟ argument that the Examiner‟s combination would have rendered Lenker‟s system inoperable for delivering an implant within a body lumen. Appellants also assert that Lenker and Griffin taught away from their combination based upon the difference in their shaft arrangement, “as well as the significant structural changes, redesign, and reconstruction that would be required in order to adapt the Lenker device to include the openings 6 described in Griffin… [and] complications that would arise regarding operation of the Lenker device….” (App. Br. 16.) Appellants further assert that “Griffin fails to identify any need, or any motivation to maintain rotational alignment” in its device. (Id. at 17.) We are not persuaded by this argument because Appellants have not established that the prior art disclosures “criticize, discredit, or otherwise discourage the solution claimed in the … application” by merely asserting differences in the devices of Lenker and Griffin. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Further, the Examiner found that the motivation for combining Lenker and Griffin was not to maintain rotational alignment in Griffin, but rather to provide Lenker with an guidewire opening that allows for a rapid exchange arrangement which enables a catheter to be quickly and efficiently passed over a guidewire by a single user, as taught by 4 Patent Application Publication No. US 2005/0149159 A1 by Bernard Andreas et al., published Jul. 7, 2005. Appeal 2011-012742 Application 11/433,328 8 Griffin. (See Ans. 5.) This reasoning is rational and supported by the evidence. Additionally, Appellants assert, regarding independent claims 1 and 12, that the guidewire opening 6 described in Griffin is formed in a proximal end wall of the guide tube 121, and is not a radial opening or an opening disposed in a sidewall of the outer shaft member, as required by claims 1 and 12, respectively. (Id. at 18-19, 20-21.) According to the Examiner, the guidewire opening in Griffin may be considered radial because it is “offset from the longitudinal axis” and when Griffin‟s Figure 22 is compared to Specification Figure 2B, both show that the opening “is at a slant with respect to the catheter such that it has both radial and longitudinal components….” (Ans. 10-11.) Further, the Examiner “believes the opening of Griffin to be in both the end wall and the side wall” due to the “angular nature of the opening….” (Id. at 12.) After considering all the evidence and arguments, we find that the Appellants have the better position. While the Specification Figure 2B and Griffin‟s Figure 22 both depict the opening offset from the longitudinal axis of the device, and at a slant, we agree with Appellants that the Griffin opening is positioned in an end wall rather than radially (i.e., characterized by divergence from a center) or specifically disposed in a side wall. We disagree with the Examiner that Griffin‟s Figure 22 supports finding that the guidewire opening 6 is “in both the end wall and the side wall.” (Ans. 12.) Accordingly, we reverse the obviousness rejection of claims 1 and 12, and their dependent claims 6-11, 14-19, 25, and 29. Regarding independent claim 21, Appellants assert that “neither Lenker, nor Thompson, nor Griffin discloses, or even suggests, any structure Appeal 2011-012742 Application 11/433,328 9 that can be reasonably characterized as the „port opening extension portion disposed inside the outer member,‟” as recited by the claim. (App. Br. 23.) According to Appellants, the Examiner‟s rejection does not find that the claimed structure is disclosed or suggested by the prior art. (Id.) Moreover, Appellants assert that Griffin does not include a guidewire lumen extension portion that extends proximally from the guide wire lumen. (Id. at 24.) While the Examiner did not separately identify the port opening extension portion in the Final Rejection, in the Response to Argument section of the Answer, the Examiner explained that with respect to claim 21 and its dependent claims “instead of [reciting] inner and outer extension members, Appellant has simply called them port opening extension portion and guidewire lumen extension portion.” (Ans. 13.) As the Examiner explained, these elements were addressed in the Final Rejection wherein the Examiner found that Griffin‟s Figure 22 disclosed an inner shaft extension 122 and an outer shaft extension 121. (Id. at 13 and 6.) Appellants have not submitted a Reply Brief establishing otherwise with persuasive evidence or argument. Accordingly, we affirm the obviousness rejection of claim 21. Appellants have not raised separate arguments for claims 23, 24, 27, and 30 which depend from claim 21. Therefore these dependent claims fall with claim 21. 37 C.F.R. § 41.37(c)(1)(vii). SUMMARY We reverse the rejection of claims 1, 6-12, and 14-19, 25, and 29 under 35 U.S.C. § 103(a) as unpatentable over Lenker, Thompson, and Griffin. Appeal 2011-012742 Application 11/433,328 10 We affirm the rejection of claims 21, 23, 24, 27, and 30 under 35 U.S.C. § 103(a) as unpatentable over Lenker, Thompson, and Griffin. 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-IN-PART cdc Copy with citationCopy as parenthetical citation