Ex Parte Falk et al

Patent Trial and Appeal Board

Mar 30, 2018

13946830 (P.T.A.B. Mar. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/946,830 07/19/2013
11050 7590 04/03/2018
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
WAYNE FALK
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
1001.2875101 8848
EXAMINER
FRERE, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
04/03/2018 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WAYNE FALK, JOEL M. W ASDYKE, and HUISUN W ANG 1
Appeal2017-006426
Application 13/946,830
Technology Center 3700
Before ANNETTE R. REIMERS, ERIC C. JESCHKE, and
BRENT M. DOUGAL, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Wayne Falk et al. (Appellants) appeal under 35 U.S.C. § 134(a) from
the Examiner's decision to reject under 35 U.S.C. § 103(a): (1) claims 1-3,
5, 6, 9-11, 13, and 14 as unpatentable over Melsheimer (US 7,892,215 B2,
issued Feb. 22, 2011) and Morris (US 5,374,286, issued Dec. 20, 1994); and
(2) claims 4, 7, 8, and 12 as unpatentable over Melsheimer, Morris, and Itou
1 In the Appeal Brief, Boston Scientific Scimed, Inc. is indicated as "the real
party in interest" of the present application. Appeal Brief 3 (hereinafter
"Appeal Br.") (filed Sept. 9, 2016).
Appeal2017-006426
Application 13/946,830
(US 2010/0217237 Al, published Aug. 26, 2010). Claims 15-20 have been
withdrawn from consideration. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to "elongated intracorporeal
medical devices including a guide extension catheter having a trackable tip."
Spec. 1:10-12, Figs. IB, IC. Claims 1and9 are independent.
Claim 1 is illustrative of the claimed subject matter and recites:
1. A guide extension catheter, comprising:
a proximal shaft having a first outer diameter;
a distal sheath attached to and extending from a distal end
of the proximal shaft, the distal sheath having a second outer
diameter greater than the first outer diameter; and
a trackable tip member attached to and axially fixed with
respect to the distal sheath and extending distally therefrom, the
trackable tip member defining a guidewire lumen therein; and
wherein the distal sheath has a first central axis and the
trackable tip member has a second central axis parallel to and
radially offset from the first central axis.
ANALYSIS
Obviousness over Melsheimer and Morris
Claims 1-3, 5, 6, 9-11, 13, and 14
Independent claim 1 is directed to a guide extension catheter including
a distal sheath and a tractable tip member, "wherein the distal sheath has a
first central axis and the trackable tip member has a second central axis
parallel to and radially offset from the first central axis." Appeal Br., Claims
App. 12. The Examiner finds that Melsheimer discloses the guide extension
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Application 13/946,830
catheter of claim 1 substantially as claimed. Final Act. 2-3. 2 The Examiner
further finds that "Melsheimer does not disclose the trackable tip member
having a second axis radially offset from the first central axis." Id. at 3. The
Examiner finds that
Morris discloses a sheath (355) (as seen in Morris Fig. 3A)
having a first central axis and a trackable tip member (335)
having a second central axis parallel and radially offset from the
first central axis wherein rotations of the sheath are easier to
count and detect when the radiopaque marker is offset.
Id. (citing Morris 2:5-16).
The Examiner concludes it would have been obvious "to have modified the
trackable tip member of Melsheimer to have a second axis radially offset
from the first central axis as disclosed by Morris wherein rotations of the
sheath are easier to count and detect when the radiopaque marker is offset."
Id.
Appellants contend that "there is no suggestion in the cited references
to offset an axis of a trackable tip member defining a guidewire lumen from
an axis of a distal sheath." Appeal Br. 8. In particular, Appellants contend
that "although Morris does appear to disclose a feature (i.e., a radiopaque
marker) offset from a lumen, nothing in the cited portions of Morris or
otherwise appears to disclose or suggest radially offsetting a central axis of a
trackable tip defining a guide wire lumen from a central axis of a distal
sheath." Id. Stated differently, "a teaching of a positioning of a radiopaque
material suggests nothing to one having ordinary skill in the art about where
to position a trackable tip member having a guidewire lumen." Id. at 8-9.
2 Final Office Action (hereinafter "Final Act.") (dated May 10, 2016).
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Application 13/946,830
Appellants' argument is persuasive. We understand that the teachings
of Morris disclose radiopaque marker 335 offset from central cavity/lumen
375 (see Morris 2:5-9, Figs. 3, 3A; see also Appeal Br. 8); however, we fail
to see and the Examiner fails to adequately explain how this arrangement
would necessarily result in trackable tip member 80 of Melsheimer having a
central axis radially offset from the central axis of distal sheath 200. See
Final Act. 2-3; see also Ans. 3-5 3; see id. at 5 (The Examiner's annotated
version of Figure 5 of Melsheimer as modified by Morris). In reference to
the Examiner's depiction of Melsheimer as modified by Morris (see Reply
Br. 3, Ans. 5), we agree with Appellants that the central axis of trackable tip
member 80 of Melsheimer would "appear[] to be the same with or without
the [modified] radiopaque material" and does not appear to be "offset from a
central axis" of distal sheath 200. See Reply Br. 3. 4 As such, the Examiner
fails to establish by a preponderance of the evidence that the combined
teachings of Melsheimer and Morris disclose the catheter of claim 1. We
further are not persuaded by the Examiner's use of design choice as the
Examiner fails to establish that "this particular arrangement is deemed to
have been known by those skilled in the art." See Final Act. 3--4, Ans. 6.
Independent claim 9 is directed to a medical device assembly and
includes language regarding the trackable tip member having a second
central axis radially offset from the first central axis of the distal sheath. See
Appeal Br., Claims App. 13-14. The Examiner relies on the same
unsupported findings in Melsheimer and Morris discussed above. See Final
3 Examiner's Answer (hereinafter "Ans.") (dated Jan. 11, 2017).
4 Reply Brief (hereinafter "Reply Br.") (filed Mar. 9, 2017).
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Appeal2017-006426
Application 13/946,830
Act. 4---6. As such, the Examiner's findings with respect to Melsheimer and
Morris are deficient for claim 9 as well.
For these reasons, we do not sustain the Examiner's rejection of
independent claims 1 and 9, as well as dependent claims 2, 3, 5, 6, 10, 11,
13, and 14 as unpatentable over Melsheimer and Morris.
Obviousness over Melsheimer, Morris, and Itou
Claims 4, 7, 8, and 12
The Examiner's rejection of claims 4, 7, 8, and 12 as unpatentable
over Melsheimer, Morris, and Itou is based on the same unsupported
findings and conclusions discussed above with respect to independent claims
1 and 9. See Final Act. 6-8. The Examiner does not rely on Itou to remedy
the deficiencies of Melsheimer and Morris. Accordingly, for reasons similar
to those discussed above for claims 1 and 9, we do not sustain the
Examiner's rejection of claims 4, 7, 8, and 12 as unpatentable over
Melsheimer, Morris, and Itou.
DECISION
We REVERSE the decision of the Examiner to reject claims 1-3, 5, 6,
9-11, 13, and 14 as unpatentable over Melsheimer and Morris.
We REVERSE the decision of the Examiner to reject claims 4, 7, 8,
and 12 as unpatentable over Melsheimer, Morris, and Itou.
REVERSED
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