Scott Davis et al.

Patent Trials and Appeals Board

Mar 25, 2021

2020000881 (P.T.A.B. Mar. 25, 2021)

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.
13/536,477 06/28/2012 Scott A. Davis 2001.1449101 8862
11050 7590 03/25/2021
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
FARRAR, LAUREN PENG
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
03/25/2021 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 SCOTT A. DAVIS and ERIC SCHNEIDER
____________________

Appeal 2020-000881
Application 13/536,477
Technology Center 3700
____________________

Before LINDA E. HORNER, MICHELLE R. OSINSKI, and
ERIC C. JESCHKE, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1–10 and 18–27.2 We have jurisdiction under
35 U.S.C. § 6(b).

We REVERSE.

1 We use the term “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Boston Scientific SciMed, Inc. as the
real party in interest. Appeal Br. 3.
2 Claims 11–17 are cancelled. Response After Final (Feb. 15, 2019), 3.
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THE CLAIMED SUBJECT MATTER
Claims 1, 18, and 20 are independent. Claim 1, reproduced below, is
illustrative of the claimed subject matter on appeal.
1. A catheter comprising:
a catheter shaft and a catheter tip, the catheter shaft
comprising a polyether block amide material and the catheter tip
comprising a polyether block amide material, the catheter tip
comprising a first longitudinal section and a second longitudinal
section joined to the first longitudinal section at a junction
therebetween, the first longitudinal section formed of polyether
block amide having a first durometer and the second longitudinal
section formed of a polyether block amide having a second
durometer greater than the first durometer, the first longitudinal
section being distal to the second longitudinal section and the
second longitudinal section being bonded to the catheter shaft
and to the first longitudinal section, the polyether block amide
material of the catheter shaft having a third durometer greater
than the second durometer, at least a portion of the first
longitudinal section being tapered and at least a portion of the
second longitudinal section being tapered;
wherein the catheter tip includes a guidewire lumen
extending through the tapered portion of the first longitudinal
section and the tapered portion of the second longitudinal
section, and wherein the guidewire lumen extends to a distalmost
extent of the catheter tip;
wherein the first longitudinal section is longitudinally
offset from the second longitudinal section such that the
polyether block amide having the first durometer and the
polyether block amide having the second durometer do not
longitudinally overlap.

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Application 13/536,477

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EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Name Reference Date
Currier US 2004/0015138 A1 Jan. 22, 2004
Tremulis US 2007/0219466 A1 Sept. 20, 2007
Appling US 2008/0108975 A1 May 8, 2008

THE REJECTION
Claims 1–10 and 18–27 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tremulis, Appling, and Currier. Final Act. 2–12.
PROCEDURAL HISTORY
The present application came before the Board previously on appeal.
See Prior Board Decision in Appeal 2017-003127, dated March 20, 2018
(“Prior Decision” or “Prior Dec.”). In the Prior Decision, the Board reversed
the Examiner’s rejections of then-pending claims 1, 6–10, and 18 under
35 U.S.C. § 102(b) as anticipated by Tremulis and claims 2–5 under
35 U.S.C. § 103(a) as unpatentable over Tremulis. Prior Dec. 8. The Board
affirmed the Examiner’s rejection of then-pending claims 1–10 and 18 under
35 U.S.C. § 103(a) as unpatentable over Tremulis and Appling. Id.
In the Prior Decision, the Board determined, among other things, that
Appellant did not “point out any flaw in the Examiner’s reasoning relating to
a guidewire facilitating insertion of a catheter through tissue into a target
vessel” to support the combination of the teachings of Tremulis and
Appling. Prior Dec. 6. Although Appellant argued that the Examiner did
not “identif[y] a deficiency of the devices of Tremulis” and that the catheters
of Tremulis “are not characterized as requiring a guidewire,” the Board
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determined such arguments to be unpersuasive in that they merely pointed to
the lack of an explicit recitation of a teaching, suggestion, or motivation to
combine references, rather than explaining how the reasoning articulated by
the Examiner lacked rational underpinnings. Id.3 After the Prior Decision,
Appellant amended the pending claims and added new claims, and the
Examiner issued a final Office action, which is the subject of the present
appeal.
OPINION
The Examiner relies on Tremulis to teach many of the limitations of
the independent claims, including a catheter shaft and a catheter tip in which
the “distal portion of the tip” comprises a first longitudinal section and the
“proximal portion of the tip” comprises a second longitudinal section. Final
Act. 2–3. The Examiner finds that “at least a portion of the first longitudinal
section [is] tapered (Fig. 4c, taper at 54 and taper at tip 56 due to the
rounded end)” and “at least . . . a portion of the second longitudinal section
[is] tapered (Fig. 4c at 54 and at portion proximal of 18a).” Id. The
Examiner also finds that “the catheter tip includes a guidewire lumen (see

3 In the Prior Decision, the Board also determined that the concentric
structure of (i) a central portion and (ii) a segment of the outer portion of the
catheter tip surrounding the central portion did not prevent Tremulis from
meeting the claim limitation of a catheter tip comprising first and second
longitudinal sections, the first longitudinal section formed of a material
having a first durometer and the second longitudinal section formed of a
material having a second durometer greater than the first durometer. Prior
Dec. 5–6. The Board also considered Appellant’s argument that Appling
failed to teach a guidewire lumen extending through tapered portions of first
and second longitudinal sections, but determined that “Appellant[] ha[s] not
persuasively explained why the Examiner’s division of Appling’s tip into
first and second sections is in error.” Id. at 7.
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lumen that exists at 54B) extending through the tapered portion of the
second longitudinal section.” Id. at 3, 6, 8.
The Examiner acknowledges, however, that “Tremulis does not
disclose a guidewire lumen that exten[d]s to a distal most exten[t] of the
catheter tip.” Final Act. 3, 6, 8. The Examiner turns to Appling, finding that
Appling “teaches a similar catheter tip (Fig. 2a, distal section after the cross
cut at C), the catheter tip having a similar shape as that of Tremulis having a
slanted distal opening (35) and further first longitudinal section (see near
39).” Id. at 4, 6, 8. The Examiner further finds that Appling “teaches a
guidewire lumen (37) extending through the tapered portion of the first
longitudinal section and the tapered portion of the second longitudinal
section and wherein the guidewire lumen extends to a distal most extent of
the catheter tip (Fig. 2a).” Id. The Examiner concludes that it would have
been obvious “to modify the device of Tremulis with the guidewire lumen of
Appling for the purpose of facilitating insertion of the catheter through tissue
into the target vessel.” Id. at 4, 7, 8 (citing Appling ¶ 54). The Examiner
takes the position that a
guidewire is only used to guide the distal tip of the catheter
through certain body tissues, [and] it is not meant to be
permanently placed in the catheter or tip. Therefore, the
guidewire is removed and the distal end of the tip may return to
its normally prolapsed shape . . . . Thus, it could be conceived
the guidewire may be used to traverse certain body tissue, but is
removed, and the distal end of the tip may then be free to
prolapse and can still be maneuvered with this configuration if
needed, without penetrating the tissues of the body lumen.
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Adv. Act. (Mar. 22, 2019), 2.4
Appellant takes the position that “there is no motivation to redesign
the prolapsing tip of Tremulis to have a guidewire lumen extending to a
distalmost extent of the tip” and “there is no rational reason for one of

4 As to the limitation that “the first longitudinal section is longitudinally
offset from the second longitudinal section such that the polyether block
amide having the first durometer and the polyether block amide having the
second durometer do not longitudinally overlap” (Appeal Br. 16 (Claims
App.)), the Examiner relies on a third reference not considered in the Prior
Decision. Final Act. 4. More particularly, the Examiner finds that, although
Tremulis teaches “the first longitudinal section formed of a polyether block
amide having a first durometer ([0038], portion 62 formed of a 35 D
PEBAX material) and the second longitudinal section formed of a polyether
block amide having a second durometer (central portion 53 [0038] made of a
40 D PEBAX section) greater than the first durometer” (id. at 2), Tremulis
and Appling “do not teach that the polyether block amide having the first
durometer and the polyether block amide having the second durometer do
not overlap” (id. at 4). The Examiner finds that Currier teaches a catheter
having a catheter tip that includes “a first longitudinal section (176, distal
region; [0008], [0069]) having a first durometer and a second longitudinal
section (174) having a second durometer greater than the first durometer
([0069], the region of 176 is softer and allows it to deflect more than 174
indicating that the second durometer is greater than the first).” Id. The
Examiner also finds that Currier teaches that “the first longitudinal section is
longitudinally offset from the second longitudinal section (Fig. 12a–12c)
such that the material having the first durometer and the material having the
second durometer do not longitudinally overlap (as shown as Fig. 12a–12c).
Id. The Examiner concludes that it would have been obvious “to modify the
device of Tremulis/Appling with the catheter tip having a first and second
longitudinal section that do not longitudinally overlap as taught by Currier
for the purpose of yielding more easily when contacting a vessel wall and
preventing damage ([0003]).” Id. The Examiner additionally explains that
modifying Tremulis in accordance with the teachings of Currier “would lead
to the same result as that of Tremulis where the distal section is flexible
enough to bend and prolapse” and “Currier is used to further provide
evidence and teachings to support that already taught by Tremulis.” Ans. 6.
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ordinary skill in the art to modify Tremulis to add the guidewire lumen of
Appling.” Appeal Br. 9, 10. Appellant asserts that “Tremulis already
teaches the device shown in FIGS. 6A–6D as having a shaft lumen 44 with
an opening 54B positioned proximal of the distalmost extent of the catheter
tip” and “[t]here is no rational reason for one of ordinary skill in the art to
add another lumen for receiving a guidewire.” Reply Br. 2.
Although we appreciate the Examiner’s position that the inclusion of a
guidewire lumen (along with the use of a guidewire) may facilitate insertion
of the catheter through tissue into a target vessel in some instances, we agree
with Appellant that the Examiner has not explained adequately why one of
ordinary skill in the art would have been led specifically to modify Tremulis
to include a guidewire lumen extending to the distalmost extent of the
catheter tip. In other words, the Examiner’s articulated reasoning explains
why one of ordinary skill in the art might have been led to use a guidewire
lumen and a guidewire generally, but does not provide adequate reasoning
for the specific modified device proposed. Tremulis already includes an
existing lumen that terminates in slanted facial opening 54, and would
accommodate a guidewire that may extend at least in part through this
existing lumen. Tremulis, Figs. 5A, 6A. The catheter of Tremulis may be
configured to allow a guidewire to exit atraumatic tip 18B proximal to the
distalmost extent of the catheter tip and still be able to accomplish the broad
stated purpose of facilitating insertion of the catheter through tissue into a
target vessel by the use of a guidewire.
Assuming that the Examiner’s modification to atraumatic tip 18B
depicted in Figs. 5A and 6A of Tremulis is specifically to include an
expanded guidewire wall segment along the section of outer portion 62 that
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is distal to central portion 53 in order to achieve a guidewire lumen
extending to a distalmost extent of the catheter tip (i.e., to include an
expanded guidewire wall segment similar to Appling’s expanded guidewire
wall segment 100 (see Appling Fig. 2B, cross-section D-D)), Appellant has
pointed out differences between the tips of Tremulis and Appling. Appeal
Br. 8–10. The differences between Tremulis and Appling call into question
whether one of ordinary skill in the art would have been led to modify the
distal tip of Tremulis to include the guidewire lumen of Appling for the
Examiner’s stated purpose of facilitating insertion of the catheter through
tissue into the target vessel.
In particular, Appellant argues that “[t]he tip of atraumatic tip 18B of
Tremulis ‘is designed to prolapse or bend over when encountering soft
tissues so that the tip does not penetrate or core out tissues in a body
lumen.’” Appeal Br. 8 (quoting Tremulis ¶ 38); see also Reply Br. 3 (citing
Tremulis ¶¶ 31–32, Fig. 2) (“Tremulis specifically teaches the atraumatic tip
18 as having a curved face and being made of soft material to minimize the
risk of perforation of the fallopian tube or sub-mucosal tissue.”) and
Tremulis ¶ 37 (“Leading edge 56B [of the embodiment of Figures 5A–5B] is
designed as a curved flange wherein an end section 58 of leading edge 56B
is located proximal to middle section 60 of leading edge 56B. The curved
flange configuration of leading edge 56B is designed for improved tip
deflection and a lower pressure on atraumatic tip 18B when the tip comes
into contact with an inner surface of a body lumen.”). Appellant continues
that “[t]he distal tip of the device of Appling is not similar to that of
Tremulis.” Appeal Br. 9.
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More specifically, Appellant asserts that, in contrast to Tremulis,
Appling’s tip “cannot be seen as being designed to prolapse or bend over
when encountering soft tissue.” Appeal Br. 9. Instead, Appling teaches that
its “distal end portion 35 acts as a dilator to provide enhanced insertion and
tracking functionality without compromising flow rates.” Id. at 8–9 (quoting
Appling ¶ 56). That is, Appling is concerned with improving insertion for
“blunt, open ended catheters [that] maintain optimal flow rates” by avoiding
reductions in the “lumen cross-sectional area [of the distal tip] compared to
the rest of the lumen” in order to reduce blood treatment times. Appling
¶¶ 11, 18. Appling is also concerned with avoiding the need for side hole
ports and additionally “having a distal end shape that creates a barrier
between the blood lumens and vessel wall.” Id. ¶ 18. Appellant maintains
that due to the differences in the devices of Tremulis and Appling, there is
no “motivation for one of ordinary skill in the art to modify Tremulis [using
the teachings of Appling] to achieve the claimed structure.” Appeal Br. 9.
Considering that Tremulis does not disclose a blunt, open-ended
catheter that would involve the same concerns as Appling (e.g., avoiding
reductions in the lumen cross-sectional area at the distal tip or creating a
barrier between the main lumen and vessel wall), the Examiner has not
articulated a sufficient reason with rational underpinnings to explain why
one of ordinary skill in the art would have been led to use the specific
guidewire lumen of Appling (i.e., an expanded guidewire wall segment
extending to the distalmost extent of the catheter tip) in order to facilitate
insertion of the catheter, when a guidewire lumen terminating proximal to
the distal tip would function effectively for the Examiner’s stated purpose of
“facilitating insertion of the catheter through tissue into the target vessel”
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(Final Act. 4) and would preserve the curved flange configuration of the
distal tip that “is designed for improved tip deflection and a lower pressure
on atraumatic tip 18B when the tip comes into contact with an inner surface
of a body lumen.” Tremulis ¶ 37.
In sum, we agree with Appellant that the Examiner’s articulated
reasoning for modifying the catheter of Tremulis depicted in Figures 5A and
6A so as to include the guidewire lumen of Appling that extends to a
distalmost extent of the catheter tip lacks rational underpinnings. That is,
the Examiner has not explained sufficiently how Appling’s specific
guidewire lumen would be seen as an improvement that would have
applicability to the curved flange configuration embodiment of the
atraumatic ablation tip illustrated in Figures 5A and 6A of Tremulis. The
Examiner’s articulated reasoning explains only why a person of ordinary
skill in the art would generally include a guidewire lumen.
We determine the Examiner has not provided an adequate articulation
of a reason why a person of ordinary skill in the art would have been led to
modify the atraumatic catheter tip of Tremulis so as to have a guidewire
lumen extending to a distalmost extent of the catheter tip, as called for in
independent claims 1, 18, and 20. For the foregoing reasons, we do not
sustain the Examiner’s rejection of claims 1, 18, and 20, and claims 2–10,
19, and 21–27 depending therefrom, under 35 U.S.C. § 103(a) as
unpatentable over Tremulis, Appling, and Currier.

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DECISION
Claim(s)
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–10, 18–27 103(a) Tremulis, Appling,
Currier
1–10, 18–27

REVERSED