Thomas Toellner

Patent Trials and Appeals Board

Sep 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.
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Application 14/985,217

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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.
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(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.
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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
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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.
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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
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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
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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
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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,
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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