Ex Parte Jagger et al

Patent Trial and Appeal BoardOct 23, 2012

11496249 (P.T.A.B. Oct. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KARL JAGGER, TRACEE EIDENSCHINK, DEREK SUTERMEISTER, DANIEL GREGORICH, YOUSEF ALKHATIB, MATT HEIDNER, ADAM JENNINGS, RICHARD C. GUNDERSON, JOHN BLIX, TIMOTHY J. MICKLEY, RICHARD OLSON, JAN WEBER, and DOMINICK GODIN __________ Appeal 2011-006284 Application 11/496,249 Technology Center 3700 __________ Before TONI R. SCHEINER, ERIC GRIMES, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. BONILLA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a catheter including a stent retaining device comprising an electroactive polymer. The Examiner has rejected claim 1 as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-006284 Application 11/496,249 2 STATEMENT OF THE CASE The Specification discloses a catheter system comprising a catheter, a stent, and a retaining device including an electroactive polymer (Spec. 3). Figures 11a and 11b show an embodiment: Figure 11a depicts a side view of a catheter with a sheath (30) disposed about the length of a stent (10), while Figure 11b shows a side view of a catheter with a sheath retracted from about the stent (id. at 4). As shown above, sheath (30) having an electroactive polymer (EAP) portion (34) is disposed about the length of stent (10) in an inactivated state (Figure 11a), and rolls off the stent when activated (Figure 11b) (Spec. 20). Electrical activation of the EAP sheath results in the sheath curling back and allowing the stent to deploy (id.). Claim 1 is the only claim on appeal and reads as follows: 1. A catheter comprising: a medical device receiving region; a stent disposed about the medical device receiving region in a reduced state for delivery; and Appeal 2011-006284 Application 11/496,249 3 a stent retaining device which is activatable to release the stent, wherein the retaining device comprises an electroactive polymer, the retaining device having different first and second shapes corresponding to activated and inactivated states of the electroactive polymer, and the retaining device configured to effect release of the stent as a result of a shape change in said portion induced by activation or inactivation of the electroactive polymer therein; wherein the retaining device is at least one sheath having a first portion and a second portion; wherein, in the inactivated state, the first portion of the at least one sheath is disposed about a length of the stent and, in the activated state, the first portion of the at least one sheath is curled back such that the first portion of the at least one sheath is disposed about the second portion of the at least one sheath. Claim 1 stands rejected under 35 U.S.C. § 103(a) as obvious over Mattison (U.S. Pat. Appl. Publ. No. 2005/0102017 A1, published May 12, 2005) in view of Wang et al. (U.S. Pat. No. 6,478,814 B2, issued Nov. 12, 2002). Analysis Claim 1 recites a catheter comprising a retaining device comprising an electroactive polymer. The retaining device has “different first and second shapes corresponding to activated and inactivated states of the electroactive polymer,” and in the activated state, a first portion of a sheath “is curled back such that the first portion of the [] sheath is disposed about the second portion of the [] sheath.” The Examiner acknowledges that Mattison does not teach a sheath that “changes shape by rolling back over itself” (Ans. 4). The Examiner asserts that Wang teaches this feature, and that it “would have been obvious Appeal 2011-006284 Application 11/496,249 4 to one of ordinary skill in the art to modify the device of Mattison „017 with a retaining sleeve that rolls back, as taught by Wang „814, in order to make it easier to release the stent” (id., see also id. at 5 (stating it would have been obvious to configure the EAP sleeves in Mattison “to cause the claimed shape change in order to provide the advantages taught by Wang „814”). Like the Examiner, we find that Mattison discloses a delivery sheath, i.e., a retaining device, comprising an electroactive polymer (EAP), where the retaining device has different shapes corresponding to activated and inactivated states of the EAP (Ans. 4; Mattison [0022], [0028]). Specifically, Mattison teaches that the EAP in the retaining device expands and contracts to tighten and relax the device‟s hold on the stent (Mattison [0028], [0031], [0043], [0044]). Mattison does not disclose or suggest curling back a retaining device, or that EAP could facilitate a curl back (Ans. 4). We agree with the Examiner that Wang discloses end sleeves, i.e., retaining devices, that “roll back upon themselves” (Wang, col. 6, ll. 53-60, col. 7, ll. 31-57; see also Figures 3, 4, 8, 9) (Ans. 4). Notably, however, the “roll back” feature disclosed in Wang relies on the properties of polytetrafluoroethylene (PTFE), a thermoplastic polymer, present in Wang‟s retaining device (Wang, col. 2, ll. 48-56; col. 4, ll. 16-18; col. 6, ll. 53-60; col. 7, ll. 51-57). In relation to this polymer, Wang teaches that a sleeve having PTFE “will have inner and outer surface characteristics which will attract one another,” and as a result, sleeves “tend to roll back upon themselves when the balloon 12 is placed in the inflated state” (id. at col. 6, ll. 53-60). Similarly, Wang states that “[a]s a result of the physical characteristics of the inside and outside hydrophobic coatings, sleeves 16, 18 Appeal 2011-006284 Application 11/496,249 5 will tend to roll back upon themselves when the inflatable portion 12 is in the inflated state” (id. at col. 7, ll. 53-57). Thus, it is the properties of the particular polymer used in Wang that cause the retaining device to curl back in an activated state. As noted by Appellants, the Examiner does not establish that Mattison or Wang, alone or in combination, teach or suggest that a retaining device “comprised of an electroactive polymer can curl back over itself when the electroactive polymer is activated” (App. Br. 10). For example, the Examiner does not suggest, or cite to evidence indicating, that an EAP has relevant characteristics similar to those of PTFE. In addition, Mattison discloses examples of EAP (Mattison [0023]) and Wang discloses “examples of suitable hydrophilic materials which may be utilized to coat the sleeve surfaces” (Wang, col. 6, ll. 47-52), but the two references do not list overlapping material. Here, Examiner has not established by a preponderance of the evidence that it would have been obvious to an ordinary artisan “to configure the electroactive polymer portions in the sleeve [of Mattison] to cause the claimed shape change in order to provide the advantages taught by Wang „814” (Ans. 5). Merely citing to “advantages taught by Wang” (Ans. 5, 4) is insufficient to show obviousness absent additional information or evidence, such as that indicating how one would have, or could have, configured the retaining device comprising EAP in Mattison accordingly. A rejection on the ground of obviousness must include “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). “[T]his Appeal 2011-006284 Application 11/496,249 6 analysis should be made explicit” and it “can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co., v. Teleflex Inc., 550 U.S. 398, 418 (2007). Because the Examiner does not explain or suggest how the cited references would have prompted one to modify a retaining device comprising EAP so that it curled back, rather than simply expand and contract as taught in Mattison (Mattison [0043]), the Examiner fails to present a prima facie case. SUMMARY We reverse the rejection of claim 1 as obvious under over Mattison in view of Wang. REVERSED cdc