Thomas Toellner

Patent Trials and Appeals BoardSep 4, 2019

14985217 - (D) (P.T.A.B. Sep. 4, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/985,217 12/30/2015 Thomas Toellner 1846265-0017-130-302 7473 145006 7590 09/04/2019 White & Case, LLP 75 State St Boston, MA 02109 EXAMINER PIATESKI, ERIN M ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 09/04/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): wcabiomedpatentsteam@whitecase.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte THOMAS TOELLNER1 ____________________ Appeal 2018-008331 Application 14/985,217 Technology Center 3700 ____________________ Before JENNIFER D. BAHR, MICHAEL J. FITZPATRICK, and BRENT M. DOUGAL, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 24–42, 44, and 45, which are the only pending claims. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 ECP ENTWICKLUNGSGESELLSCHAFT MBH (Appellant) is the applicant as provided in 37 C.F.R. § 1.46 and is identified as the real party in interest. Appeal Br. 3. Appeal 2018-008331 Application 14/985,217 2 THE CLAIMED SUBJECT MATTER Claims 24 and 34 are independent. Appeal Br. 19, 20–21 (Claims App.). Claim 24, reproduced below, with pertinent limitations italicized for emphasis, is illustrative of the claimed subject matter. 24. An intracardiac blood pump system comprising: a sheath for delivering an intracardiac blood pump assembly percutaneously, the sheath having a flared distal end with a continuous surface, the distal end formed of a fixed-shape material; and the blood pump assembly coupled to the flared distal end of the sheath, the blood pump assembly comprising: a proximal section with an outer diameter that is smaller than an inner diameter of the sheath, a radial shoulder adjacent to and distal from the proximal section, wherein the radial shoulder has a constant outer diameter that is larger than an outer diameter of the flared distal end of the sheath, and a distal portion with an outer diameter that is smaller than the outer diameter of the shoulder. REJECTIONS I. Claims 24–30, 34–39, 44, and 45 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Siess et al. (US 2004/0044266 A1, published Mar. 4, 2004, hereinafter “Siess”), Shannon (US 2002/0183777 A1, published Dec. 5, 2002), Forber (US 5,984,944, issued Nov. 16, 1999), and Lenker et al. (US 6,350,278 B1, issued Feb. 26, 2002, hereinafter “Lenker”). II. Claims 31–33 and 40–42 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Siess, Shannon, Forber, and McBride et al. Appeal 2018-008331 Application 14/985,217 3 (US 2006/0062672 A1, published Mar. 23, 2006, hereinafter “McBride”).2 DISCUSSION Rejection I Independent claim 34, like independent claim 24, recites a “sheath having a flared distal end with a continuous surface.” Appeal Br. 19, 20 (Claims App.). Further, claim 24 recites that the flared distal end is “formed of a fixed-shape material,” and claim 34 recites that the flared distal end “has a fixed shape.” Id. at 19, 21. The Examiner finds that Siess’s sheath (rigid tube 37 of sluice 36) does not have “a flared distal end formed of a fixed-shape material.” Final Act. 3–4. The Examiner relies on Shannon and Forber for these features. See id. at 4. More specifically, the Examiner finds that “Shannon teaches an expandable percutaneous medical device introduced by a sheath . . . that may have a flared distal end.” Id. (citing Shannon, Figs. 2–5; ¶¶ 1, 21). The Examiner determines it would have been obvious to modify Siess by including “a flared distal end on the sheath because it makes it easier to 2 Claims 31–33 and 40–42 depend, through claims 30 and 39, from independent claims 24 and 34, and, thus, incorporate all the limitations of claims 24 and 34, including the “continuous surface” limitation for which the Examiner relies on Lenker. Appeal Br. 20, 21–22 (Claims App.); Final Act. 4–5. However, the Examiner omits Lenker from the statement of the rejection of claims 31–33 and 40–42, and relies on McBride for other features not related to the “continuous surface” limitation. See Final Act. 7– 8. Thus, it appears the Examiner’s omission of Lenker from Rejection II may have been inadvertent. Appeal 2018-008331 Application 14/985,217 4 remove the deflated pump when necessary, because deflated pumps do not always return easily into the sheath due to ‘winging.’” Id. (citing Shannon ¶¶ 9, 23, 28). The Examiner finds that “Shannon does not teach that the sheath has a flared distal end formed of a fixed-shape material.” Id. (emphasis added). The distal end of Shannon’s strain relief tube 40 “can reversibly assume a funnel-shaped configuration 30, as . . . generally shown in FIG. 4, and a collapsed configuration 60 as generally shown in FIG. 5.” Shannon ¶ 40 (boldface omitted, emphasis added). However, the Examiner finds that “Forber teaches [an] intracardiac sheath with a fixed-shape flared distal end.” Final Act. 4 (citing Forber, Figs. 11, 13). The Examiner determines: It would have been obvious to one having ordinary skill in the art, based on Forber’s teachings, that even a non-expandable device may be used percutaneously, with a fixed-shap[e] flared end, in order to avoid the problem cited by Shannon, with the dangers of removing a deflated pump because of the potential for snagging. It would further have been obvious to one having ordinary skill in the art that such a sheath may be used for both delivery and for retrieval of the pump, so long as the puncture in the vein is made by a device other than the sheath with the flared end, because the flared end may be fit through an existing puncture. Forber’s rigid and fixed-shape flared end would avoid the possibility of the flared end collapsing when returning the pump to the sheath after use, which is a risk with Shannon's pump sheath, and keeps the end in an open position for accepting the pump easily. Id. The Examiner finds that Siess, modified as discussed above in view of Shannon and Forber, “does not teach that the flared distal end of the sheath has a continuous surface.” Id. The distal end of Forber’s collet tube 70 has longitudinal slit 76, which bifurcates it for a length L2 into portions 75 and Appeal 2018-008331 Application 14/985,217 5 77. Forber, Figs. 5, 9, 11, 13; id. 5:36–38. In view of Lenker’s teaching of a sheath having a flared distal end having a continuous surface, the Examiner determines it would have been obvious “to use a flared distal end with a continuous surface [on rigid tube 37 of Siess’s sluice 37] because as demonstrated by Lenker, such devices may be used to firmly grasp [an] end of the implantable device, through use of a cup-like shape, in order to deliver implantable devices to their final location.” Final Act. 4–5 (citing Lenker, Figs. 19A–19D (sheath 260 having proximal anchor 258 to introduce expandable prosthesis P)). Appellant argues that the Examiner’s rationale for modifying Siess’s sluice 36 to have a flared distal end is based on hindsight and, further, that such a modification would render Siess unsuitable for its intended purpose by either requiring a smaller pump size, thereby reducing pump capacity, or by increasing the diameter at the distal end of the sluice, thereby hindering insertion of the sluice. See Appeal Br. 9–12. Appellant argues that Siess’s shape memory cannula “is guided into the compressed position by the lattice structure” and, thus, “does not experience winging as presented by [Shannon’s deflated dilation balloon].” Id. at 14. Furthermore, according to Appellant, even if a person of ordinary skill in the art were prompted by the issue of “winging” to provide a flared distal end on Siess’s sluice, the person of ordinary skill in the art would not have provided a fixed-shape flared distal end because this would not prevent “winging.” Id. Rather, Appellant contends, one would have provided “a collapsible flared funnel-shaped strain relief tube that aids in the collapse and removal of the balloon,” as taught by Shannon, to solve a perceived “winging” problem. Id. Appeal 2018-008331 Application 14/985,217 6 Siess discloses an expandable and collapsible cannula that comprises a supporting structure consisting either of intersecting elastic wires or webs of shape memory alloy, which make it possible to expand the outer diameter of the cannula from about 4 mm to about 5.5 mm or more. Siess ¶¶ 6, 30, 32. Shannon discusses “a phenomenon known as ‘winging[,’] in which the flat, lateral portions, or flaps, of the deflated balloon project laterally outward.” Shannon ¶ 9. Siess does not discuss withdrawing the pump, much less give any indication that the “winging” phenomenon discussed by Shannon in the context of inflatable dilation balloons would occur with the cannula described by Siess, which is provided with a supporting structure that seemingly would prevent flattening and the formation of flaps seen with deflated balloons. Thus, there is at least some merit to Appellant’s argument that the Examiner’s articulated reason for the proposed modification (providing a flared distal end on Siess’s sluice tube 37) is not very compelling. Further, even assuming one of ordinary skill in the art would have been prompted to provide a flared distal end on Siess’s sluice to facilitate withdrawal of the cannula, Shannon teaches a technique for doing so that would not require the outer diameter of the flared distal end to be any larger than the outer diameter of the remainder of the sluice when the sluice is introduced into the body through the puncture channel. Specifically, as discussed above, Shannon teaches providing a strain relief tube that can reversibly assume a funnel-shaped configuration and a collapsed configuration. See Shannon, Figs. 4, 5; ¶¶ 23, 28, 40. Shannon teaches passing the strain relief tube with the collapsed balloon through a shroud tube and out the distal end of the shroud tube, where the distal end of the Appeal 2018-008331 Application 14/985,217 7 strain relief tube (no longer compressed by the shroud tube) expands to form a flared, funnel shape; inflating the balloon; deflating the balloon to the collapsed configuration while moving the balloon proximally within the strain relief tube; and then, once the balloon is in the collapsed configuration and fully within the strain relief tube, withdrawing the strain relief tube into the shroud tube where the distal end collapses back into its collapsed (non- flared) configuration shown in Figure 3; and then removing the catheter device. Id., Figs. 1–2; ¶¶ 28, 42. Following the teachings of Shannon, one could provide a sluice having a distal end capable of assuming a reversible flared configuration after it has been inserted into the body through the puncture channel and of assuming a collapsed, or compressed configuration for insertion through the puncture. By having a flared distal end that is not of fixed shape, it is possible to attain the advantage of a flared distal end after insertion into the body without increasing the outer diameter of the distal end relative to the outer diameter of the remainder of the sluice during insertion through a puncture. Thus, especially for the reasons that follow, it is not apparent why one of ordinary skill in the art would have been inclined to provide Siess’s sluice with a flared distal end that (1) has a continuous surface and (2) has a fixed shape or is made of a fixed-shape material (i.e., a distal end that is not capable of assuming a collapsed shape in addition to the flared, funnel shape). Siess desires to provide an intravascular pump that can be introduced into the body by puncturing, by means of the Seldinger technique, and that is also capable of providing the required throughflow of 2 to 2.5 liters per minute. Siess ¶ 2. One of ordinary skill in the art would have inferred from Siess’s disclosure in paragraphs 2 and 5 that components having dimensions Appeal 2018-008331 Application 14/985,217 8 much larger than 4.0 mm either should not be, or cannot be, introduced through a puncture using the Seldinger technique. One of ordinary skill in the art would also have understood from Siess that there are practical limits on how small the minimum inner diameter of the sluice can be and still accommodate rigid components of the pump of sufficient size, and a cannula of the pump expandable to sufficient diameter, to provide the required throughflow. See id. ¶¶ 2, 4–6, 26–30, 35, 36, 38. For insertion of Siess’s pump, with its drive portion 11 and expandable cannula 18, the inner diameter of tube 37 of sluice 36 should be somewhat larger than 4 mm. See id. ¶¶ 6, 26, 35. In order to provide a sluice having both the required minimum diameter to accommodate a sufficient capacity pump and a distal end outer diameter sufficiently small to be introduced through a puncture using the Seldinger technique, a person having ordinary skill in the art would have wanted to provide a sluice distal end diameter that is as close as possible to the minimum diameter of the sluice, at least during insertion of the sluice through the puncture channel. Thus, if a person of ordinary skill in the art were inclined to provide a flared distal end on Siess’s sluice, as proposed by the Examiner, in order to avoid “winging” when receiving the expandable/collapsible pump cannula when in use inside the body lumen, such a person would have recognized that providing a distal end having a reversible flared, funnel-shape that is also capable of being collapsed for passage into the body, as taught by Shannon, would be desirable, and would not have seen any advantage to providing a distal end of fixed shape. As discussed above, the Examiner relies on Forber and Lenker in formulating a reason to provide Siess’s sluice with a flared distal end having Appeal 2018-008331 Application 14/985,217 9 a continuous surface and a fixed shape. Final Act. 4 (proposing to first modify Siess to provide a bifurcated distal end and then further modify it to provide a distal end with a continuous surface). However, as Appellant points out, Forber’s collet tube is designed to grasp and compress a vaso- occlusion device, and Lenker, as characterized by the Examiner, teaches devices having a flared distal end having a continuous surface that “may be used to firmly grasp [an] end of the implantable device, through use of a cup-like shape, in order to deliver implantable devices to their final location.” Appeal Br. 15–16; Final Act. 4–5. However, Siess’s sluice 36 is not used to grasp an end of the pump, and, thus, it is not evident why a person having ordinary skill in the art would have looked to Forber or Lenker for teachings directed to the formation of the distal end of tube 37 of Siess’s sluice 36. See Appeal Br. 15–16. We additionally note that, as discussed above, the distal end of Forber’s collet tube is slit to bifurcate it into two portions, which can be compressed toward one another into a collapsed configuration or permitted to expand outwardly into a flared shape. See Forber 6:36–38; 8:7–11. Thus, the distal end of Forber’s collet tube has neither a fixed shape nor a continuous surface. Moreover, because Forber and Lenker teach devices for delivering prostheses collapsible to a significant degree relative to their deployed configuration, and not for delivering an intravascular pump that must be of sufficient size to provide a required throughflow, Forber and Lenker need not take into account the minimum sluice diameter constraints of concern with Siess’s device. For the above reasons, the Examiner’s articulated reasons for modifying Siess’s sluice to have a flared distal end with a continuous surface and a fixed shape are not supported by rational underpinnings. Accordingly, Appeal 2018-008331 Application 14/985,217 10 we do not sustain the rejection of independent claims 24 and 34, or their dependent claims 25–30, 35–39, 44, and 45, as unpatentable over Siess, Shannon, Forber, and Lenker. Rejection II The deficiency in the rejection of claims 24 and 34 also pervades the rejection of claims 31–33, which depend from claim 24, and claims 40–42, which depend from claim 34. Appeal Br. 19, 21–22; Final Act. 7–8. The Examiner’s application of McBride does not remedy this deficiency. Final Act. 7–8. Accordingly, we do not sustain the rejection of claims 31–33 or claims 40–42 as unpatentable over Siess, Shannon, Forber, and McBride. DECISION The Examiner’s decision rejecting claims 24–42, 44, and 45 is reversed. REVERSED