Ex Parte Eder et al

Patent Trial and Appeal BoardSep 27, 2012

09957980 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JOSEPH C. EDER, STANLEY W. OLSON, JR., PAUL C. SLAIKEU, and ROBERT M. ABRAMS ____________________ Appeal 2011-012692 Application 09/957,980 Technology Center 3700 ____________________ Before EDWARD A. BROWN, MICHELLE R. OSINSKI, and SCOTT E. KAMHOLZ, Administrative Patent Judges. BROWN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2011-012692 Application 09/957,980 2 STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. Â§ 134(a) from the Examiner's decision rejecting claims 1-3, 10-13, 20-24, 26-29, 31, and 32. (App. Br. 1). Claims 4-9, 14-19, 25, and 30 have been canceled. (Id.). We have jurisdiction over this appeal under 35 U.S.C. Â§ 6(b). We affirm. THE CLAIMED SUBJECT MATTER The claimed subject matter is directed to a vaso-occlusive device. Claim 1, reproduced below, is illustrative. 1. A vaso-occlusive device comprising: a biocompatible member having a coil configuration, said coil configuration having a positive pitch between each turn, said member having an outer surface; a rigid, blunt tip attached to at least one end of said member, said blunt tip having a cross-sectional dimension extending completely across the diameter of said coil configuration, said rigid, blunt tip having an outer surface; an inner bioactive coating on substantially the entire outer surface of said member, said inner bioactive coating on substantially the entire outer surface of said rigid, blunt tip, and said inner bioactive coating permanently bonded to both said member and said rigid, blunt tip; and an outer coating covering substantially the entire area of said inner coating prior to elution of the outer coating, said outer coating being dissolvable and comprising a hydrophilic agent that affects the solubility of said outer coating. Appeal 2011-012692 Application 09/957,980 3 THE REJECTION Claims 1-3, 10-13, 20-24, 26-29, 31, and 32 under 35 stand rejected under U.S.C. Â§ 103(a) as unpatentable over Kupiecki (US 5,669,931; issued Sep. 23, 1997), Neuss (US 5,536,274; issued Jul. 16, 1996), and Ritchart (US 4,994,069; issued Feb. 19, 1991). ANALYSIS The Examiner found Kupiecki discloses a vaso-occlusive device comprising, inter alia, a biocompatiable support member, and an inner bioactive coating comprising a thrombogenic material or a material that causes a tissue reaction, on the entire outer surface of the member. (Ans. 4). The Examiner found Kupiecki does not disclose that the thrombogenic material is permanently bonded to the member. (Ans. 5). The Examiner found Neuss teaches this limitation, and concluded that it would have been obvious to one of ordinary skill in the art to modify the inner bioactive coating of Kupiecki's device so that it is permanently bonded to the member to "ensure a continuous thrombotic effect where the device is implanted." (Ans. 5). The Examiner also found Kupiecki does not disclose "an outer coating being dissolvable and comprising a hydrophilic agent that affects the solubility of the outer coating." (Ans. 5). The Examiner found Ritchart discloses a flexible vaso-occlusive device including an outer coating that is dissolvable and comprises a hydrophilic agent that affects the solubility and time for release of the outer coating. (Ans. 5) (citing Ritchart col. 5, l. 62 â€“ col. 6, l. 5, Figs. 4A, 4B). The Examiner concluded that it would have been obvious to one of ordinary skill in the art, in view of Ritchart, to apply an outer coating as claimed onto Kupiecki's device, stating "[s]uch a coating would rigidify the device for its deployment through blood vessels and cure Appeal 2011-012692 Application 09/957,980 4 the deficiency of Kupiecki et al. in view of Neuss, where [Kupiecki] et al. disclose, in col. 7, lines 7-20, that their device is 'flexible' and exhibits 'little column strength' (like the device of Ritchart et al.)." (Ans. 5-6). We have considered Appellants' contentions set forth in their Briefs, but do not find them persuasive for the reasons discussed infra. Appellants contend that Kupiecki describes Ritchart's device as unsatisfactory. (App. Br. 3-4) (citing Kupiecki col. 1, l. 65 â€“ col. 2, l. 16; col. 2, ll. 42-44). Appellants contend that Kupiecki improves upon Ritchart's device and describes an extremely flexible coil. (App. Br. 4-5). Appellants contend that Kupiecki favors hydraulic delivery of the device because of the extreme flexibility of the coil. (App. Br. 5). Appellants also contend that one of ordinary skill in the art would not look to Neuss and Ritchart to cure Kupiecki's deficiencies because Neuss and Ritchart are directed to coils that are adapted to be deliverable by pushing into a vessel lumen, but not to extremely flexible coils that are hydraulically delivered. (App. Br. 5). Appellants further contend that a person skilled in the art would have no reason to coat Kupiecki's coil with Ritchart's rigidifying substance, when Kupiecki is focused on maintaining extremely flexible coils even when they are coated with a drug material and/or a thrombogenic material. (App. Br. 5) (citing Kupiecki, col. 7, ll. 7-9.) Appellants contend that Ritchart's rigid, water-soluble material "acts to hold a flexible, coiled wire in its linear condition until the material is contacted with aqueous medium, either in the delivery catheter or at the vessel site." (App. Br. 5) (citing Ritchart, col. 3, ll. 14-20), and that this modification would render Kupiecki's device unsatisfactory for its intended purpose (App. Br. 6). Appellants' contentions are not persuasive. Appeal 2011-012692 Application 09/957,980 5 In response, the Examiner disagreed that the modification of Kupiecki's device to include Ritchart's rigid coating would render the device inoperable for its intended purpose. (Ans. 6-7). The Examiner found Kupiecki discloses that hydraulic delivery is only a preferred delivery means for the device. (Ans. 7) (citing Kupiecki col. 4, ll. 11-14, which describes: "Referring to the drawings . . . occlusive implants or devices and preferred modes for their delivery are shown in accordance with the principles of the present invention.") The Examiner also found Kupiecki does not exclude catheterization as a means for device delivery, and its invention is is also deliverable hydraulically. (Ans. 7). While Kupiecki discloses that "[the occlusive implants] preferably are hydraulically delivered to the desired site as opposed to being mechanically pushed[]" (see Kupiecki, col. 7, ll. 20-21), Kupiecki discloses mechanical delivery as well. Appellants have not identified any disclosure in Kupiecki that its implants could not be mechanically delivered to a desired body site. The Examiner also stated: Ritchart provides the teaching of a flexible, vaso- occlusive device having low column strength (comparable to Kupiecki's device), where the device is rigidified with an outer coating and is delivered to a vasculature site reachable by catheterization. The outer coating eventually dissolves in the body and allows the device, like Kupiecki's device, to "conform to blood vessels having a complex geometry ... exert little radial force ... and minimize the risk of trauma or even perforation to the blood vessels" (as the Appellant stated in arguments of August 2, 2010). A rigidifying coating for the flexible coil, as taught by Ritchart, advantageously allows Kupiecki's device to be delivered to a patient's body, where Appeal 2011-012692 Application 09/957,980 6 catheterization is the desired or likely means of delivery. In short, Kupiecki's device, as modified by Ritchart, would remain satisfactory for it intended purpose. (Ans. 7-8) (emphasis added). We agree with the Examiner. Kupiecki describes Ritchart's vaso-occlusive devices, as follows: "Ritchart et al., shows a flexible, preferably coiled, wire for use in small vessel vaso-occlusion. Unlike vaso-occlusive coils previously, Ritchart et al. teaches a coil which is fairly soft and is delivered to the site using a pusher within a catheter lumen." (See Kupiecki, col. 2, ll. 3-7) (emphasis added). Ritchart applies a rigid coating to the flexible wires to hold them in a linear condition until the material is contacted with an aqueous medium, which can occur at the vessel site. (See Ritchart, col. 3, ll. 14-17). While Appellants contend that "[t]here is no indication that Kupiecki's coils are even amenable to delivery using a pusher wire, or a guidewire" (App. Br. 7), Appellants also acknowledge that "Kupiecki does not explicitly deny pushing a coil with an insertion guidewire or with a pusher wire into a vessel lumen" (Reply Br. 2). Appellants have provided no persuasive argument or evidence as to why Kupiecki's coils, as coated with Ritchart's rigid coating, could not be delivered mechanically to a body site. Appellants also state that "Kupiecki's delivery method directly relates to his extremely flexible coil, which fulfills the need of 'a liquid coil type fluid delivery embolism forming device.'" (Reply Br. 2). However, Appellants also have provided no persuasive argument or evidence as to why Kupiecki's coils, as coated with Ritchart's rigid coating, could not alternatively be delivered hydraulically. One of ordinary skill in the art would appreciate that providing Ritchart's rigid coating on Kupiecki's coils would be desirable for Appeal 2011-012692 Application 09/957,980 7 delivery purposes, in that this modification would not prevent the coils from being delivered hydraulically, and it would increase the rigidity of the coils for mechanical delivery. In addition, Ritchart discloses that its water-soluble, rigid coatings are effective to hold the wire in its linear condition until contacted with an aqueous medium at the delivery site. Appellants have provided no persuasive argument or evidence as to why Kupiecki's coils, as coated with Ritchart's rigid coating, would be unable to provide their "fluid-like properties" (Kupiecki, col. 7, l. 11) in vessels to which they have been delivered, once the rigid coating has dissolved. In KSR, the Supreme Court stated that "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-16 (2007). Here, Appellants have not shown by persuasive argument or evidence that the combined teachings of Kupiecki, Neuss, and Ritchart would not have yielded predictable results. Appellants also have not established that this combination of teachings would have been beyond the level of ordinary skill in the art. Accordingly, we agree with the Examiner's conclusion of obviousness. We sustain the rejection of claims 1-3, 10-13, 20-24, 26-29, 31, and 32. DECISION The Examiner's decision rejecting claims 1-3, 10-13, 20-24, 26-29, 31, and 32 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(1)(iv). AFFIRMED Appeal 2011-012692 Application 09/957,980 8 mls