Ex Parte Stehr et al

Patent Trial and Appeal Board

Nov 7, 2013

11910503 (P.T.A.B. Nov. 7, 2013)

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.
11/910,503 10/02/2007 Richard E. Stehr 0B-046908US 6495
55714 7590 11/08/2013
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION
Kite & Key, LLC
P.O. Box 315
Hamel, MN 55340-0315
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
11/08/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RICHARD E. STEHR and XIAOPING GUO
____________

Appeal 2012-001909
Application 11/910,503
Technology Center 3700
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1-12 (App. Br. 4).2
Examiner entered rejections under 35 U.S.C. § 102(b) and 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The claims are directed to a splittable reinforced flexible tubular body
for a catheter or sheath. Claims 1 and 9 are representative and are
reproduced in the Claims Appendix of Appellants’ Brief.

1 The Real Party in Interest is St. Jude Medical, Atrial Fibrillation Division,
Inc. (App. Br. 2.)
2 Pending “[c]laims 13-35 stand withdrawn from consideration” (App. Br.
4).
Appeal 2012-001909
Application 11/910,503

2
Claims 1 and 2 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Morris.3
Claims 3, 4, and 8 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Morris and Bühler.4
Claims 5-7 and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Morris, Bühler, and Potter.5
Claims 10-12 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Morris and Potter.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Morris teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Morris’ “invention relates generally to an introducer system having a
kink resistant sheath for the insertion of catheters and other instruments into
the body and more particularly to an introducer system having a kink
resistant splittable sheath used to introduce pacemaker leads into the venous
system” (Morris, col. 1, ll. 5-9).

3 Morris, US 5,713,867, issued Feb. 3, 1998.
4 Bühler et al., US 4,402,685, issued Sept. 6, 1983.
5 Potter et al., US 2004/0267203 A1, published Dec. 30, 2004.
Appeal 2012-001909
Application 11/910,503

3
FF 2. Morris’ Figures 16 and 19 are reproduced below:

“FIG. 16 depicts a lead introducer system in accordance with one
embodiment of [Morris’] … invention” (id. at col. 3, ll. 20-21). “FIG. 18 is
a detailed cross-sectional view of the wall of the kink resistant sheath used in
an introducer system of the [Morris’] … invention” (id. at ll. 24-26).
FF 3. Morris teaches a sheath 61 having “a two-part construction with a
tubular portion 71 having at least one reinforcing fiber 72 integral
therewith,” wherein, as illustrated in FIG. 19, “a score line 63 [is] cut into
both the sheath wall and the reinforcing fibers” to permit the sheath “to be
longitudinally split apart along [the] score line” (id. at col. 5, ll. 32-34 and
col. 6, ll. 13-18 (emphasis added); see generally Ans. 5 and 10-11).
FF 4. Morris teaches that “[v]arious other equivalent means may … be
used to accomplish splitting [the] sheath 61 along [the score] line 63
includ[ing] … providing a line of weakened wall” or constructing the entire
wall “using material having the physical property of molecular orientation
whereby a tear in the material runs readily only in a longitudinal direction
along the length of [the] sheath 61” (id. at col. 6, ll. 20-28; see generally
Ans. 5 and 10-11).

Appeal 2012-001909
Application 11/910,503

4
ANALYSIS
Claim 1 is drawn to a splittable reinforced flexible tubular body for a
catheter or sheath, comprising, inter alia, a wall structure that includes (1) a
reinforcement layer within the wall structure and (2) a separation line
extending longitudinally along the wall structure and adapted to facilitate the
splitting of the wall structure (Appellants’ Claim 1). Claim 1 also requires
that the reinforcement layer is formed without introducing discontinuities
thereto (id.).
Examiner finds, inter alia, that Morris teaches a sheath that comprises
a reinforcement layer, wherein the reinforcement layer is “formed without
introducing discontinuities thereto” because Morris teaches that the sheath
61 can be split along a score line 63 “by either scoring the sheath [61] or by
alternative means including providing a line of weakened wall or using
specific materials to allow the splitting” (Ans. 5 and 10). We are not
persuaded. Morris teaches that “a score line 63 [is] cut into both the sheath
wall and the reinforcing fibers” to permit the sheath “to be longitudinally
split apart along [the] score line” (FF 3). While Morris teaches that
“[v]arious other equivalent means may … be used to accomplish splitting
[the] sheath 61 along [the score] line 63,” Examiner failed to establish an
evidentiary basis on this record to support a finding that Morris’ teaching of
alternatives to cutting the sheath wall also make it unnecessary to cut into
the reinforcing fiber (see FF 4; Cf. FF 3 (“a score line 63 [is] cut into both
the sheath wall and the reinforcing fibers”); see also App. Br. 9 (“While
Morris does teach a reinforcing layer …, Morris only discloses the
introduction of discontinuities for splitting that layer”)).
Appeal 2012-001909
Application 11/910,503

5
In the alternative, Examiner finds that while Morris’ reinforcing fiber
is scored, as illustrated in Fig. 19, the “scores [63] are shorter in length than
the diameter of fiber 72 and … [since] the scores do not completely cut
through the fibers …, completely break or interrupt the individual fibers …
the reinforcing member is … ‘formed without introducing discontinuities
thereto’” (Ans. 11). In support of this assertion, Examiner finds that
Appellants’ Specification fails to define the term “discontinuous” and “the
broadest reasonable definition [of the term is, as set forth in the American
Heritage Dictionary of the English Language,] … ‘marked by breaks or
interruptions’” or, as set forth in Macmillan Dictionary, “not continuing
without being stopped or interrupted” (Ans. 11). We are not persuaded. As
Appellants explain “[a] scored reinforcing layer, even if the ‘scores do not
completely cut through the fibers,’ necessarily has discontinuities introduced
to it…. Put simply, a score is a discontinuity in the scored material” (Reply
Br. 4-5).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Morris teaches Appellants’ claimed invention. The
rejection of claims 1 and 2 under 35 U.S.C. § 102(b) as being anticipated by
Morris is reversed.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
Appeal 2012-001909
Application 11/910,503

6
FACTUAL FINDINGS (FF)
FF 5. Examiner finds that Morris fails to suggest a “separation line [that]
is a strip of first polymer material that is different from a second polymer
material utilized to form the rest of the wall structure wherein a bond
interface between the two materials creates a stress concentration that
facilitates the splitting of the wall structure” and relies on Bühler to make up
for this deficiency (Ans. 6-7 (emphasis added)).
FF 6. Examiner finds that Morris fails to suggest a “separation line [that]
is defined by a peel groove longitudinally extending along the wall
structure” and relies on Potter to make up for this deficiency (id. at 8
(emphasis added)).
FF 7. Examiner finds that the combination of Morris and Bühler fails to
suggest a separation line, comprising two polymers, wherein “the first
polymer material is more radiopaque” and relies on Potter to make up for
this deficiency (id. at 7).
FF 8. Examiner finds that Morris alone or in combination with Bühler fails
to suggest a “reinforcement layer [that] is pre-stressed or pre-treated without
being severed to fail [sic] along a longitudinal path that aligns with the
separation line” (id. at 8 and 9).
FF 9. Examiner relies on Potter to suggest a cannula comprising a
radiopaque marker ring, wherein the radiopaque marker “may be grooved,
scored, serrated, or provided with a sidewall having weakened or reduced
material cross-sections … generally corresponding to the location of the
score lines …, grooves, or other splitting means running along the
longitudinal axis of the sheath” (see id.; Potter 4: ¶¶ [0044]-[0045]).
Appeal 2012-001909
Application 11/910,503

7
ANALYSIS
Claims 3-12 depend directly or indirectly from claim 1. Examiner
failed to establish that Morris in combination with Bühler or Potter alone or
in combination makes up for the deficiency in Morris discussed above (see
App. Br. 10; Cf. FF 5-8). At best, Examiner finds that Potter suggests a pre-
stressed or pre-treated radiopaque marker ring that is unsevered (see FF 8-9).
Examiner failed to establish an evidentiary basis on this record to support
Examiner’s characterization of the radiopaque marker ring as a
reinforcement layer (see FF 8). Further, assuming arguendo that Potter’s
radiopaque marker ring could be a reinforcement layer, Examiner failed to
establish that it would have been prima facie obvious to use such a layer, as
described by Potter, to replace Morris’ reinforcement layer (see Ans. 8-9).
Instead, Examiner concludes that, at the time Appellants’ invention was
made, it would have been prima facie obvious to “include a pre-treated layer
without being severed, as taught by Potter et al., for the purpose of aiding in
splitting of the sheath” (Ans. 8 and 9). Examiner failed to explain why a
person of ordinary skill in this art would have included an additional
reinforcement layer to Morris’ structure, which already includes a
reinforcement layer, to facilitate splitting of the sheath (see FF 3).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
For the foregoing reasons, we are compelled to reverse the
obviousness rejections on this record.
Appeal 2012-001909
Application 11/910,503

8
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 3, 4, and 8 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Morris and Bühler is reversed.
The rejection of claims 5-7 and 9 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Morris, Bühler, and Potter is reversed.
The rejection of claims 10-12 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Morris and Potter is reversed.

REVERSED

cdc