Jessica Ash. Warring et al.

Patent Trials and Appeals Board

Jun 8, 2020

2018008921 (P.T.A.B. Jun. 8, 2020)

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.
14/250,093 04/10/2014 Jessica Ash Warring 101672.0230P3 7069
158673 7590 06/08/2020
BD/Rutan & Tucker, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
06/08/2020 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):
ip.docket@bd.com
patents@rutan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JESSICA ASH WARRING, AMIR BELSON, and
WINFIELD SCOTT FISHER
____________________

Appeal 2018-008921
Application 14/250,093
Technology Center 3700
____________________

Before BENJAMIN D. M. WOOD, JILL D. HILL, and
MICHAEL L. WOODS, Administrative Patent Judges.

WOOD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134 from a November 6, 2017
Final Action rejecting claims 1–13. Claims 14–25 have been canceled.
Appeal Br. 5. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part, and enter a new ground of rejection.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies the real party in interest as Vascular Pathways, Inc.
Appeal Br. 5.
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THE CLAIMED SUBJECT MATTER
The claims are directed to an intravenous catheter insertion device and
method of use. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1 A method for accessing a blood vessel lumen,
comprising:
providing a catheter insertion device having
an access needle, a catheter disposed coaxially over
the access needle and a guidewire disposed in a
lumen of the access needle and having a distal tip
preformed into a coil configuration;
advancing the access needle through a
patient's skin to position a distal tip of the access
needle in a lumen of the blood vessel;
advancing the guidewire from the distal end
of the access needle into the blood vessel lumen,
wherein the distal tip of the guidewire is maintained
in a straightened configuration in the access needle
and recovers the coil configuration in the blood
vessel lumen, and wherein the distal tip of the
guidewire inhibits puncturing or damaging the blood
vessel wall as the guidewire is advanced; and
advancing the catheter over the guidewire.
REFERENCES
Chuttani
Lewis
Wilson
Wensel
Whiting
US 5,054,501
US 5,246,426
US 6,197,001 B1
US 6,436,112 B2
US 8,029,470 B2
Oct. 8, 1991
Sep. 21, 1993
Mar. 6, 2001
Aug. 20, 2002
Oct. 4, 2011
Lederman US 2003/0032936 A1 Feb. 13, 2003
REJECTIONS
Claims 10 and 11 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement.
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Claims 1–7 are rejected under 35 U.S.C. § 103 as unpatentable over
Lewis and Lederman.
Claim 8 is rejected under 35 U.S.C. § 103 as unpatentable over Lewis,
Lederman, and Whiting.
Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over
Lewis, Lederman, and Wensel.
Claim 13 is rejected under 35 U.S.C. § 103 as unpatentable over
Lewis, Lederman, and Chuttani.
Claims 1–3 and 5–7 are rejected under 35 U.S.C. § 103 as
unpatentable over Wilson and Lederman.
Claim 4 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Lederman, and Lewis.
Claim 8 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Lederman, and Whiting.
Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Lederman, and Wensel.
Claim 13 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Lederman, and Chuttani.
Claims 1–3, 7–9, and 13 are rejected under 35 U.S.C. § 103 as
unpatentable over Wilson and Chuttani.
Claim 4 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Chuttani, and Lewis.
Claim 5 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Chuttani, and Lederman.
Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over
Wilson, Chuttani, and Wensel.
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ANALYSIS
Claims 10 and 11—Rejected as Failing the Enablement Requirement
Claim 10 depends from claim 6. Claim 6 depends from claim 1 and
additionally recites “wherein the coil configuration includes a first coil
extending from a straight portion of the guidewire, the first coil lying
substantially in a first coil plane.” Appeal Br. 46 (claims app.). Claim 10
additionally recites “wherein the coil configuration includes a second coil
extending from the first coil, the second coil lying in a second coil plane
parallel to the first coil plane.” Id. Claim 11 depends from claim 10. Id.
The Examiner determines that “[i]t is unclear how two coils can each
lie in separate ‘coil planes’ that are parallel to each other since the
connection between the two coils must follow an incline from the first to the
second coil; due to this incline joining the two coils, it does not appear that
the individual coils can each lie in a respective single plane.” Final Act. 3.
The Examiner explains that:
While Fig 25B shows two coil[s] that have portions that lie
parallel to one another (i.e. the portions of the coils that are facing
out of the page in Fig 25B), it cannot be said that coils themselves
lie in coil planes that are parallel since planes are inherently two-
dimensional while two joined coils that are ‘stacked’ (for lack of
a better word) as seen in Fig 25B must each be three-
dimensional.
Id. at 3–4.
Appellant first responds that the Examiner should not have rejected
claims 10 and 11 under 35 U.S.C. § 112(a) because, according to MPEP
§ 707.07(g), “[c]ertain technical rejections (e.g., negative limitations,
indefiniteness) should not be made where the examiner, recognizing the
limitations of the English language, is not aware of an improved mode of
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definition.” Appeal Br. 11–12. According to Appellant, “[t]he Examiner
clearly recognizes the limitations of the English language in describing the
coil configuration of claim 10: ‘[T]wo joined coils […] are ‘stacked’ (for
lack of a better word) as seen in Fig 25B[.]’” Id (quoting Final Act. 3–4)
(alterations made by Appellant). Appellant also disagrees with the
Examiner’s implicit interpretation of claim 10 as requiring “that the first coil
lies entirely in the first coil plane, the second coil lies entirely in the second
coil plane, and the first and second coil planes are parallel.” Id. at 12.
Appellant asserts that “the claims do not specify how much of the first coil
lies in the first coil plane nor how much of the second coil lies in the second
coil plane,” and “any three points of a coil can define a plane, or ‘coil
plane.’” Id.
Section 112 requires a written description to enable “those skilled in
the art how to make and use the full scope of the claimed invention without
‘undue experimentation.”’ Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381
F.3d 1142, 1155 (Fed. Cir. 2004) (internal citation omitted). Whether undue
experimentation is needed is not a single, simple factual determination, but
is a conclusion reached by weighing many factual considerations. In re
Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Wands factors include: (a)
the quantity of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working examples,
(4) the nature of the invention, (5) the state of the prior art, (6) the relative
skill of those in the art, (7) the predictability or unpredictability of the art,
and (8) the breadth of the claims. Id. “[T]he PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the
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description of the invention provided in the specification of the
application.” In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993).
The Examiner has not made any findings regarding whether undue
experimentation is required for one of ordinary skill in the art to make and
use the invention of claim 10, much less considered any of the Wands
factors. Therefore, the Examiner has not established a prima facie case of
lack of enablement, and we do not sustain this rejection.
NEW GROUND OF REJECTION UNDER 37 C.F.R. § 41.50(b)
Claims 10 and 11—Rejected Under 35 U.S.C. § 112(a) as Failing the
Written Description Requirement
To satisfy the written description requirement, a disclosure must
reasonably convey to one skilled in the art that the applicant had possession
of the subject matter in question when the application was filed. Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc). Determining possession requires an objective inquiry into the “four
corners of the specification from the perspective of a person of ordinary skill
in the art.” Id. at 1351.
Although we agree with the Examiner that claims 10 and 11 should be
rejected under 35 U.S.C. § 112(a), the proper basis to do so is under the
written-description requirement. For claim 10, we are unable to discern any
disclosure in the Specification for a coil configuration that includes a first
coil in a first coil plane and a second coil in a second coil plane that is
parallel to the first coil plane. For example, Figure 4B depicts a first and
second coil in the same plane rather than each in separate, parallel planes.
Spec. ¶ 52, Fig. 4B. Figures 25A and 25B depict two coils that are three
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dimensional, and thus cannot be said to be “in” a two-dimensional plane, as
claim 10 requires.
Appellant contends that a “coil plane” can be defined by any three
points on each of the coils depicted in Figure 25B. Appeal Br. 12. But the
Specification does not support this contention—the Specification does not
appear to use the term “coil plane,” much less define it as any three
randomly selected points on a coil. Such a definition would mean little, as
there would be an infinite number of possible planes that could be defined
by the selection of any three of an infinite number of points on each coil.
For the above reasons, we determine that claim 10 is not adequately
described by the Specification. Claim 11 depends from claim 10 and
therefore is likewise not adequately described.
Claims 1–7—Rejected as Unpatentable over Lewis and Lederman
Appellant argues claims 1, 2, and 4–7 as a group, and argues claim 3
separately. Appeal Br. 13–25. We select claim 1 as representative of the
grouped claims, and decide the appeal of the rejection of these claims on the
basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv). We discuss claim 3
separately.
Claim 1
The Examiner relies on Lewis to teach the method of claim 1, except
for the limitation requiring the distal tip of the guidewire to be preformed
into a coil configuration that is maintained in a straightened configuration in
the access needle and that recovers the coil configuration in the blood vessel
lumen. Final Act. 5 (citing Lewis, 10:22–25, 35–40, 47–50, Figs. 1, 8B).
For the limitation missing from Lewis, the Examiner relies on Lederman,
particularly Lederman’s guide wire 24 and its distal end pigtail 42. Id. at 5–
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6 (citing Lederman ¶¶ 37–38, Fig. 3). The Examiner finds that Lederman
teaches that distal end pigtail 42 reduces the chance of accidentally
puncturing or damaging blood vessels, and that one of ordinary skill in the
art would have been motivated to modify Lewis’s device such that its
guidewire includes Lederman’s preformed coil configuration for that
purpose. Id. at 6 (citing Lederman ¶ 38, Fig. 3).
We have reviewed each of Appellant’s arguments for patentability of
claim 1, but find them unpersuasive of Examiner error. Accordingly, we
sustain the Examiner’s rejection of claim 1 as unpatentable over Lewis and
Lederman for essentially those reasons expressed in the Final Action and
Answer. We add the following primarily for emphasis.
Appellant argues that “the proposed modification would change the
function and the principle of operation of Lewis.” Appeal Br. 18. Appellant
asserts that “changing the spherical tip of the Lewis guidewire . . . into the
pigtail shown in Lederman, would both obstruct and interfere with the entry
of blood into the first flashback chamber” through a needle port adjacent the
distal tip of the needle. Id. at 18–19 (citing Lewis, 8:65–66, 9:13–15, Fig.
8B). In support of this assertion, Appellant provides an annotated version of
Lewis’ Figure 8B purporting to show the Lewis’ guidewire, modified to
have Lederman’s pigtail, entering the distal flashback port 70d on Lewis’
needle 14. Id. at 19. According to Appellant, “the Lederman pigtail would
at least partially recoil in the first flashback chamber once the restraint
provided by the inner wall of the needle is removed.” Id. at 20.
The Examiner disagrees with Petitioner’s analysis. The Examiner
asserts that Appellant’s position “that the pigtail would necessarily enter into
port 70d and the hypothetical visual depiction of it is not supported by
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evidence.” Ans. 12. According to the Examiner, “one of ordinary skill in
the art would find that the distal end of Lewis could be modified to have a
pigtail without interfering with entry of blood into Lewis’ flashback
chamber,” by, e.g., changing the radius of curvature of Lederman’s pigtail,
or changing the direction in which the pigtail curves (i.e., away from the
port). Id. In its Reply Brief, Appellant responds that changing the radius or
curvature would still result in interference between the guidewire and the
flashback port because the guidewire is “subject to being torqued,” which
may turn the pigtail into the flashback port.
Appellant’s argument is not persuasive of Examiner error. The
argument is based on the bodily incorporation of Lederman’s pigtail into
Lewis’ device, rather than the combination of teachings as proposed by the
Examiner in the articulation of the rejection. “The test for obviousness is
not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference . . . [r]ather, the test
is what the combined teachings of the references would have suggested to
those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA
1981) (citations omitted); see also Orthopedic Equip. Co. v. United States,
702 F.2d 1005, 1013 (Fed. Cir. 1983) (“Claims may be obvious in view of a
combination of references, even if the features of one reference cannot be
substituted physically into the structure of the other reference.”). One of
ordinary skill can use his or her ordinary skill, creativity, and common sense
to make the necessary adjustments and further modifications to result in a
properly functioning device. See KSR International Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007) (“the [obviousness] analysis need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
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a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ”).
Appellant also argues that “there is no teaching in Lederman of the
pigtail of the guidewire being maintained in a straightened configuration in
the access needle, as required.” Appeal Br. 21. In response, the Examiner
points to Lederman Paragraphs 26 and 35 and Figures 2–5 as teaching this
limitation. Ans. 13. According to the Examiner, “Paragraph 26 explicitly
states ‘guide wire 24 has been inserted into guide wire lumen 12 via guide
collar 24’ which means that the distal end 42 (which has the coil
configuration when outside the lumen 12) is inserted distally into lumen 12
through guide collar 22 prior to it extending distally out from port 40.” Id.
Appellant disagrees with this reading of Lederman. Appellant asserts
that “[u]se of the term ‘via’ is wholly ambiguous in this regard as it can
simply mean ‘through.’” Reply Br. 15. According to Appellant, this
reading “allows for the end of the guidewire opposite the pigtailed-end to be
inserted into the guide wire lumen 12 first then through the guide collar 22.”
Id. Appellant provides an annotated version of Lederman Figure 1 that
illustrates this process. Id. Appellant further contends that Lederman
discloses inserting the guidewire prior to the catheter being introduced, and
that the pigtail aids “in guiding the catheter 10 by providing a capture for the
catheter 10 as it slides along the guide wire 24 via guide wire lumen 12.” Id.
at 15–16 (quoting Lederman ¶ 38). Appellant asserts that “[t]he capture
mechanism of the pigtail relies on the pigtail maintaining the coil
configuration for the capture,” and “maintaining the coil configuration of the
pigtail permits the catheter to be steered by the pigtail.” Id.
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This argument does not persuade us of Examiner error. We agree
with the Examiner that the most reasonable reading of Paragraph 26 of
Lederman is that distal pigtail end 42 of guide wire 24 is inserted through
guide collar 22, then through into the proximal end of guide wire lumen 12,
finally “emerging from the distal end 20 of catheter 10.” Lederman ¶ 26.
Because guide wire 24 fits “snugly” into guide wire lumen 12 (Lederman
¶ 35), it is reasonable to infer that the pigtail must be “maintained in a
straightened configuration” while it is still in guide wire lumen 12 and
before it emerges from the distal end of catheter 10. Appellant maintains
that “via” can mean “through,” but it is not entirely clear how interpreting
“via” in this manner demonstrates error in the Examiner’s reading of
Paragraph 26.2 For example, it is difficult to square Appellant’s apparent
belief that guide wire 24 first enters catheter 10 at its distal end 20 with
Paragraph 26’s teaching that guide wire 24 “emerg[es] from the distal end
20 of catheter 10.” Lederman ¶ 26 (emphasis added). Appellant also does
not explain why the fact that the pigtail acts as a “capture” and permits
steering of the guide wire demonstrates error in the Examiner’s finding.3

2 Because Lederman can be fairly read to teach the coil being maintained in
a straightened configuration while in the needle, it is not necessary to rely on
Lederman inherently disclosing it. See In re Baird, 16 F.3d 380, 383 (Fed.
Cir. 1994) (holding that a “reference must be considered not only for what it
expressly teaches, but also for what it fairly suggests”) (internal quotation
marks omitted).
3 Appellant argues that the Examiner has not provided a motivation or
reasonable expectation of success “to support any additional modification of
the Lederman-tipped Lewis guidewire to include a straightened
configuration when in an access needle.” Appeal Br. 23–24. This argument
is moot, however, because we agree with the Examiner that Lederman fairly
teaches the straightened configuration when in an access needle, and thus
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Claim 3
Claim 3 depends from claim 1 and additionally recites “wherein the
advancing the catheter over the guidewire comprises advancing the catheter
over the distal tip of the guidewire to straighten the distal tip of the
guidewire.” Appeal Br. 45 (claims app.). The Examiner finds that Lewis
teaches this additional limitation. Final Act. 6 (citing Lewis, 10:47–50).
Appellant responds that the references do not teach straightening the pigtail
because Lederman does not teach a straightened configuration of the pigtail.
Appeal Br. 25. Appellant relies on arguments made in connection with
claim 1 above (id.), which we found unpersuasive. Accordingly, we sustain
the Examiner’s rejection of claim 3 as unpatentable over Lewis and
Lederman.
Claim 8—Rejected as Unpatentable over Lewis, Lederman, and Whiting
Claim 8 depends from claim 7. Appeal Br. 46 (claims app.). Claim 7
depends from claim 1 and additionally recites “wherein the coil
configuration has a coil width (cw) and coil span (cs).” Id. Claim 8
additionally recites “wherein the coil configuration comprises a preformed
spiral including a plurality of turns.” Id. The Examiner relies on Whiting
for the additional limitation of claim 8. Final Act. 7. The Examiner finds,
inter alia, that Whiting’s coil and Lederman’s coil are “art recognized
equivalents”:
[S]ince the spiral of Whiting has the same peripheral shape as the
spiral of Lederman, the spiral of Whiting would also have the
same benefits as those of Lederman. Since Lederman’s spiral
configuration and Whiting’s spiral configuration provide the

additional modification of the Lederman-tipped Lewis guidewire is not
necessary to include this configuration.
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same function and could be used to achieve the same result, both
spiral configurations were art-recognized equivalents at the time
the invention was made and it would have been obvious to one
of ordinary skill in the art to form Lederman’s spiral with a
plurality of turns since it has been held that substituting
equivalent configurations involves only routine skill in the art.
Final Act. 7–8.
Appellant does not appear to dispute the Examiner’s finding that
Whiting Figure 2 depicts a coil configuration that comprises a preformed
spiral including “a plurality of turns.” Appeal Br. 26–27.4 Further,
Appellant does not address the Examiner’s finding that Whiting’s and
Lederman’s coil configurations are “art-recognized equivalents” and would
have “achieve[d] the same result,” except on the basis of arguments that we
previously found unpersuasive. Id. at 26. “[W]hen a patent claims a
structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result.” KSR, 550 U.S. at 416. As
Appellant has not shown error in the Examiner’s findings that Lederman’s
coil and Whiting’s coil are art-recognized equivalents that would have
achieved the same result, we sustain this rejection.

4 We note, however, that it is not entirely clear what the term “turns” means
in claim 8. The Specification does not use “turns” in the context of
describing coils or coil configurations. Instead, the Specification describes
coils in terms of their diameter, coil width, coil span, how much of a
“revolution” they comprise, and their “angular displacement” through which
the coils “move” (presumably from a “straight configuration” to the distal
end of the coil). Spec. ¶¶ 52–53, 107).
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Claim 12—Rejected as Unpatentable over Lewis, Lederman, and Wensel
Appellant relies on dependency from claim 1 for patentability of claim
12. Appeal Br. 27. Because we sustained the Examiner’s rejection of claim
1, we likewise sustain the Examiner’s rejection of claim 12.
Claim 13—Rejected as Unpatentable over Lewis, Lederman, and Chuttani
Claim 13 depends from claim 1, and additionally recites “wherein the
guidewire has a first diameter region, a taper or transition region, and a
second diameter region formed into the coil configuration.” Appeal Br. 46
(claims app.). The Examiner finds that Chuttani teaches this additional
limitation. Final Act. 9 (citing Chuttani, 3:20–24). The Examiner
determines that one of ordinary skill in the art would have modified the
Lewis/Lederman guidewire such that it has a first diameter region, a taper
and a second diameter region formed into a coil configuration “for the
purpose of increasing flexibility.” Id.
Appellant argues that the Examiner’s rationale for modifying
Lederman’s guidewire in accordance with Chuttani, to increase flexibility,
would interfere with the functionality of a “bend or kink” in Lederman’s
pigtail, which Lederman teaches “may be used to assist manipulation of the
catheter into apposition with the target structure.” Appeal Br. 28 (citing
Lederman ¶ 38, Fig. 7). Appellant also asserts that increased flexibility
would diminish the transmission of torque to Lederman’s pigtail. Id.
These arguments are not persuasive of Examiner error. First, as the
Examiner notes, “Lederman does not require a bend or kink as asserted by
Appellant; rather, Lederman only discloses an optional bend or kink.” Ans.
19. More importantly, the Examiner is not combining Lederman’s teaching
of this optional bend or kink, or Lederman’s teaching that its pigtail be
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“torquable,” or the capture and steering capability of Lederman’s guidewire,
with Lewis’ guidewire. As the Examiner states:
[I]t appears that the Appellant may be under the impression that
the combination used in the rejections would replace Lewis’
guidewire with Lederman’s guidewire; this is incorrect, as the
rejections clear[ly] set forth that Lewis’s own guidewire is
modified to have a preformed coil configuration of the type
taught by Lederman, not replaced with Lederman’s guidewire.
Ans. 11. Appellant does not allege that Lewis’ guidewire, modified to have
Lederman’s pigtail, would be incompatible with the increased flexibility
provided by including a first diameter region, a taper and a second diameter
region formed into a coil configuration, as Chuttani teaches.
Claims 1–3 and 5–7—Rejected as Unpatentable over Wilson and Lederman
Appellant argues claims 1–3 and 5–7 as a group. Appeal Br. 29–32.
We select claim 1 as representative of the grouped claims, and decide the
appeal of the rejection of these claims on the basis of claim 1 alone.
37 C.F.R. § 41.37(c)(1)(iv).
The Examiner relies on Wilson to teach the method of claim 1, except
for the limitation requiring the distal tip of the guidewire to be preformed
into a coil configuration that is maintained in a straightened configuration in
the access needle and that recovers the coil configuration in the blood vessel
lumen. Final Act. 9–10 (citing Wilson, 7:36–37, 43–46, 54–57, Fig. 1). For
the limitation missing from Wilson, the Examiner relies on Lederman,
particularly Lederman’s guide wire 24 and its distal end pigtail 42. Id. at 10
(citing Lederman ¶¶ 37–38, Fig. 3). The Examiner finds that Lederman
teaches that distal end pigtail 42 reduces the chance of accidentally
puncturing or damaging blood vessels, and that one of ordinary skill in the
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art would have been motivated to modify Lewis’ device such that its
guidewire includes Lederman’s preformed coil configuration for that
purpose. Id. (citing Lederman ¶ 38).
We have considered Appellant’s arguments but are not persuaded that
the Examiner erred in rejecting claims 1–3 and 5–7 as unpatentable over
Wilson and Lederman. Appellant first argues that Wilson “would deter a
person of ordinary skill from the proposed modification.” Appeal Br. 30.
According to Appellant, “[a] configuration that prevents kinking is an
important feature of Wilson’s guidewire,” but “the Lederman pigtail
includes a permanent or rigid bend or kink.” Id. As noted above, however,
the bend or kink in Lederman’s pigtail is an optional feature. See Lederman
¶ 38 (“A bend or kink within the pigtail distally may be used . . .”) (emphasis
added). Moreover, the Examiner is not relying on this feature of
Lederman’s pigtail in its proposed combination, and there is nothing in
Lederman that associates this feature with the Examiner’s reason to combine
Lederman and Wilson: protecting blood vessels from accident puncture.
Appellant also argues that Lederman’s guidewire does not have the
claimed straightened configuration, and that there is no motivation or
reasonable expectation of success in modifying the Lederman-tipped Wilson
guidewire to have such a configuration. Appeal Br. 31–32. We find these
arguments unpersuasive, however, for the same reasons discussed above in
connection with the Lewis-Lederman rejection.
For the above reasons, we sustain the Examiner’s rejection of claims
1–3 and 5–7 as unpatentable over Wilson and Lederman.
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Claim 4—Rejected as Unpatentable over Wilson, Lederman, and Lewis
Claim 4 depends from claim 1 and additionally recites “retracting the
guidewire into the access needle, wherein the distal tip of the guidewire
transitions from the coil configuration to the straightened configuration
during the retracting.” Appeal Br. 45 (claims app.). The Examiner finds
that Lewis teaches retracting guidewire 16 into an access needle 14 to ensure
proper feeding of the guidewire in the access needle. Final Act. 11 (citing
Lewis, 10:8–11, Figs. 1, 4). The Examiner determines that it would have
been obvious to modify the Wilson-Lederman method—which includes
using a guidewire having Lederman’s straightened configuration—to include
the step of retracting the guidewire into the access needle, as taught by
Lewis, “for the purpose of ensuring proper feeding of the guidewire in the
access needle.” Id. at 11–12 (citing Lewis, 10:8–11).
Appellant raises a number of arguments against this rejection, none of
which is persuasive. Appellant first argues that the Examiner’s reason to
combine “relies upon impermissible hindsight.” Appeal. Br. 33. But
Appellant then acknowledges that the Examiner’s reason to combine “is
derived from a passage in Lewis.” Id. (citing Lewis, 10:1–21). As our
reviewing court has stated, “[a]ny judgment on obviousness is in a sense
necessarily a reconstruction based on hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of ordinary
skill in the art at the time the claimed invention was made and does not
include knowledge gleaned only from applicant's disclosure, such a
reconstruction is proper.” In re McLaughlin 443 F.2d 1392, 1395 (CCPA
1971). The Examiner’s rationale “is derived from Lewis,” and therefore
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18
relies on knowledge within the level of ordinary skill in the art at the time of
the invention.
Appellant also contends that “it is self-evident that a person of
ordinary skill would not be motivated to further modify the Lederman-
modified vascular access device of Wilson to retract a guidewire to simply
ensure a proper feeding of the guidewire.” Appeal Br. 33. This contention
is attorney argument, unsupported by evidence or persuasive argument, and
therefore is given no weight. See In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997).
Appellant asserts that “modification of the Lederman-modified
vascular access device of Wilson with Lewis . . . would require a substantial
reconstruction and redesign of the Lederman-modified vascular access
device of Wilson, as well as a change in the basic principle under which the
Wilson’s device was designed to operate.” Appeal Br. 34. This, too, is
unsupported attorney argument, and therefore not persuasive.
In its Reply Brief, Appellant argues that “retrieving the Wilson
guidewire with Lederman’s pigtail, retracting the modified guidewire while
loading the spring, and resetting the trigger for the modified guidewire
would be problematic.” Reply Br. 24. But Appellant does not explain why
the proposed modification would be “problematic,” or provide evidence in
support of this contention.
For the above reasons, we sustain the Examiner’s rejection of claim 4
as unpatentable over Wilson, Lederman, and Lewis.
Claim 8—Rejected as Unpatentable over Wilson, Lederman, and Whiting
Appellant repeats the arguments for the patentability of claim 8 that it
made in connection with the Examiner’s rejection of claim 8 over Lewis,
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Lederman, and Whiting. Appeal Br. 34–36. Because we found these
arguments unpersuasive, we sustain the Examiner’s rejection of claim 8 as
unpatentable over Wilson, Lederman, and Whiting.
Claim 12—Rejected as Unpatentable over Wilson, Lederman, and Wensel
Appellant relies on dependency from claim 1 for patentability of claim
12. Appeal Br. 36. Because we sustained the Examiner’s rejection of claim
1, we likewise sustain the Examiner’s rejection of claim 12.
Claim 13—Rejected as Unpatentable over Wilson, Lederman, and Chuttani
Appellant repeats the arguments for the patentability of claim 13 that
it made in connection with the Examiner’s rejection of claim 13 over Lewis,
Lederman, and Chuttani. Appeal Br. 36–37. Because we found these
arguments unpersuasive, we sustain the Examiner’s rejection of claim 13 as
unpatentable over Wilson, Lederman, and Whiting.
Claims 1–3, 7–9, and 13—Rejected as
Unpatentable over Wilson and Chuttani
As with the above rejection based on Wilson and Lederman, the
Examiner relies on Wilson to teach all of the limitations of claim 1 except
for the distal tip of the guidewire preformed in a coil configuration that is
maintained in a straightened configuration while in the access needle. Final
Act. 14–16. The Examiner relies on Chuttani for the missing limitation,
finding that Chuttani teaches using guidewire 10 having “distal tip 15+25,”
preformed into a coil configuration. Id. at 15 (citing Chuttani, 4:67–5:19,
Figs. 1–6). According to the Examiner, Chuttani’s distal tip:
inhibits puncturing or damaging the blood vessel wall as the
guidewire is advanced (because coils 15 align distal-most portion
25 in the center of the lumen, as seen in Fig 1) for the purpose of
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20
cannulating tubular or vascular organs to allow the passage of
devices into these organs for diagnosis and treatment.

Id. (citing Chuttani, 2:24–26, 4:67–5:19, 5:23–26, Figs. 1, 3, 4, 6).
Appellant asserts that the coils on Chuttani’s guidewire are not located
at the distal tip of the guidewire, as claim 1 requires. Appeal Br. 38.
Appellant also argues that Chuttani is “silent” regarding the coils “inhibiting
punctures or damage to blood vessel walls,” but rather teaches that that
function is performed by the “soft rounded end” of the guidewire. Id. at 39–
40. Thus, according to Appellant, one of ordinary skill in the art would not
have been led to include Chuttani’s coils for that purpose.
The Examiner responds that “the claims do not require that the
claimed ‘distal tip’ be only the distal-most part of the guidewire or extend
only a certain distance proximally; the claims also do not require that the
entire claimed ‘distal [tip]’ be coiled.” Ans. 26. The Examiner thus
considers the “distal tip” of Chuttani’s guidewire to include both the coiled
section and the straight section. The Examiner also asserts that “[a]lthough
Chuttani does not explicitly state that the vessels within which the device
can be used are ‘blood vessels,’” the invention relates to “a flexible,
steerable guide wire for retrograde or antegrade cannulation of tubular or
vascular organs,”, and “blood vessels (which are structures accessed by the
Wilson device) are tubular and vascular organs.” Id. at 28 (citing Chuttani,
2:24–26). Thus, according to the Examiner, “one of ordinary skill in the art
would recognize that the structure [coils or “helix” 15 and straight section
25] would benefit the Wilson guidewire in the same manner since Chuttani’s
guidewire provides these benefits when used in tubular and vascular
organs.” Id.
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21
We do not sustain this rejection. The claim requires the coil
configuration to be at the “distal tip” of the guidewire. Chuttani’s coils are
set back from the distal tip of its guidewire, the distal tip occupied by a
straight section of guidewire. Chuttani, Fig. 1. Moreover, there is nothing
in Chuttani suggesting that its guidewire coils protect from accidental
puncture. Rather, the coils are used to help maneuver the guidewire through
spiraled channels, particularly the “valves of Heister” in the cystic duct. Id.
at 5:10–19. Although the Examiner is correct that the invention “generally”
relates to “a flexible, steerable guide wire for . . . cannulation of tubular or
vascular organs,” Chuttani teaches using the coils on its guidewire (the
specific structure that the Examiner proposes combining with Wilson) for a
more specialized purpose: to help navigate spiral channels. Thus, we are
not persuaded that one of ordinary skill in the art would have been motivated
to include Chuttani’s coiled structure in a device not intended for use in a
vessel that did not have spiral channels.
Remaining Rejections
The remaining rejections of claims 4, 5, and 12 rely on the erroneous
finding that one of ordinary skill in the art would have combined Chuttani’s
guidewire coils with Wilson’s guidewire. Final Act. 17–19. The additional
references are not relied on to cure this deficiency. Id. Therefore, for the
reasons stated above, we do not sustain these rejections.
DECISION
The following table summarizes our disposition of the rejections at
issue in this appeal:
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Claims
Rejected
35 U.S.C.
§
Reference(s)/
Basis 
Affirmed Reversed New
Ground
10, 11 112(a) Enablement 10, 11
10, 11 112(a) Written
Description
10, 11
1–7 103 Lewis,
Lederman
1–7
8 103 Lewis,
Lederman,
Whiting
8
12 103 Lewis,
Lederman,
Wensel
12
13 103 Lewis,
Lederman,
Chuttani
8
1–3, 5–7 103 Wilson,
Lederman
1–3, 5–7
4 103 Wilson,
Lederman,
Lewis
4
8 103 Wilson,
Lederman,
Whiting
8
12 103 Wilson,
Lederman,
Wensel
12
13 103 Wilson,
Lederman,
Chuttani
13
1–3, 7–9,
13
103 Wilson, Chuttani 1–3, 7–9,
13

4 103 Wilson,
Chuttani, Lewis
4
5 103 Wilson,
Chuttani,
Lederman
5
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Claims
Rejected
35 U.S.C.
§
Reference(s)/
Basis 
Affirmed Reversed New
Ground
12 103 Wilson,
Chuttani,
Wensel
12
Overall
Outcome
  1–8, 12, 13 9 10, 11

FINALITY OF DECISION
This decision contains a new ground of rejection under 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, “must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new Evidence relating to the claims so rejected, or
both, and have the matter reconsidered by the examiner, in which event the
prosecution will be remanded to the examiner . . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same Record.”
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED-IN-PART
37 C.F.R. § 41.50(b)