Cook Medical Technologies LLC

Patent Trials and Appeals Board

Sep 29, 2021

2020005936 (P.T.A.B. Sep. 29, 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.
14/196,664 03/04/2014 Tiffani Cannon 8627-4065 (PA-7364-RFB) 8837
48003 7590 09/29/2021
Crowell/Cook - Chicago
Crowell & Moring
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
SCHWIKER, KATHERINE H
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
09/29/2021 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 TIFFANI CANNON, BRENT A. MAYLE, and
JAMES C. MERK
Appeal 2020-005936
Application 14/196,664
Technology Center 3700
Before MICHAEL J. FITZPATRICK, JEREMY M. PLENZLER, and
CARL M. DEFRANCO, Administrative Patent Judges.

DEFRANCO, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–6, 11–18, 20, 21, and 25–29. Claims
7 and 22–24 are canceled, while claims 8–10 and 19 are withdrawn. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm in part.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to a stent deployment system
provided with inner catheters and a pusher band for deploying the stent

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies Cook Medical Technologies LLC as the real
party in interest. Appeal Br. 4.
Appeal 2020-005936
Application 14/196,664

2
within a patient. Spec. ¶¶ 2–3. Claims 1, 28, and 29 are independent.
Claim 1, reproduced below, is illustrative of the claims on appeal.
1. An inner catheter for deployment of a stent having a
radially open structure, the inner catheter comprising:
a pusher band, a first tubular member coupled to the
pusher band, and a second tubular member,
the pusher band having a passage extending from a first
end to a second end of the pusher band, the passage having a
first portion extending from the first end to a position between
the first end and the second end, and a second portion extending
from the second end to the position, the first portion of the
passage having a first cross-sectional area and the second
portion of the passage having a second cross-sectional area
less than the first cross-sectional area to form a step at the
position, an outer surface surrounding the first portion tapering
to define a tapered first end, the pusher band having an outer
diameter at the first end less than an outer diameter at the
second end, the second end being a terminal end for applying a
force to an end of the stent;
the first tubular member comprising a first end and
terminating at a second end, the first tubular member having a
rigidity to resist deformation during deployment of the stent,
the first tubular member entering the pusher band at the
tapered first end of the pusher band, the second end of the first
tubular member being within the first portion of the passage of
the pusher band and abutting the step such that the second end
of the first tubular member is unable to pass through the second
portion; and
the second tubular member being formed from a
polymeric material and comprising a first end and a second end
and defining a lumen therethrough, the lumen being sized to
accommodate a wire guide, a portion of the second tubular
member being within the passage of the pusher band, the
second end of the second tubular member extending away from
the second end of the pusher band and being configured to
extend through the stent.
Appeal Br. 32 (Claims App.) (emphases added).
Appeal 2020-005936
Application 14/196,664

3
REJECTIONS ON APPEAL2
1. Claims 27–29 stand rejected under 35 U.S.C. § 112 ¶ 1, as
lacking written description support.
2. Claims 1, 11–17, 20, 21, 25, and 26 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Newell (US 2013/0226276 A1,
published Aug. 29, 2013) and Gill (US 2012/0310320 A1, published Dec. 6,
2012). See Final Act. 2–5.
3. Claims 2–5 are rejected under § 103(a) as being unpatentable
over Newell, Gill, and Dorn (US 2009/0204197 A1, published Aug. 13,
2009).
4. Claims 3 and 6 are rejected under § 103(a) as being
unpatentable over Newell, Gill, and Fahey (US 2006/0100687 A1, published
May 11, 2006).
5. Claim 18 is rejected under § 103(a) as being unpatentable over
Newell, Gill, Fahey, and Dorn.
6. Claims 1, 3, 6, 11–17, 20, 21, and 25–29 stand rejected under
§ 103(a) as being unpatentable over Fahey and Gill.
7. Claims 2, 4, 5, and 18 are rejected under § 103(a) as being
unpatentable over Fahey, Gill, and Dorn.
ANALYSIS
A. Written Description (Claims 27–29)
The Examiner determines that the claim limitation that “the second
tubular member is longitudinally slidable relative to the pusher band,” as

2 The Examiner withdrew the rejection of claims 27 and 28 as being
unpatentable over Newell, Gill, and Wallace (US 6,669,719 B2, issued
Dec. 30, 2003). See Ans. 3.
Appeal 2020-005936
Application 14/196,664

4
recited in claim 27 and essentially the same in claims 28 and 29, lacks
written description support. Final Act. 4–5.
We disagree. As Appellant correctly notes, the Specification
describes “another configuration” of the stent deployment system in which
the second tubular member (element 248 in Figure 5) “can be decoupled
from or not attached to the pusher band” and “can, in effect, float within the
passage 220 of the pusher band 218.” Appeal Br. 15 (quoting Spec. ¶ 27)
(emphasis added). That description, in our view, would reasonably inform
one skilled in the art that the inventor contemplated an embodiment where
the second tubular member slides within the passage of the pusher band,
independent of and relative to movement of the pusher band. Thus, we do
not sustain the Examiner’s rejection of claims 27–29 as lacking adequate
written description support.
B. Obviousness
1. Newell and Gill (Claims 1, 11–17, 20, 21, 25, and 26)
We begin with claim 1. The Examiner finds that Newell teaches
substantially all the elements of claim 1, except for (1) the passage within
the pusher band having one cross-sectional area less than another cross-
sectional area to form a step within the pusher band, (2) the first tubular
member having a second end that enters the first end of the pusher band and
abuts the step such that the second end of the first tubular member is unable
to pass through the pusher band, and (3) the second tubular member defining
a lumen therethrough for accommodating a wire guide. Final Act. 5–7
(citing Newell ¶¶ 92, 131, 218, annotated Fig. 4B). For those missing
elements, the Examiner finds that Gill teaches “a similar catheter for
deployment of a medical device,” including a pusher band and first tubular
Appeal 2020-005936
Application 14/196,664

5
member having a configuration as claimed. Id. at 7–9 (Gill ¶¶ 27, 33, 35,
36, 59, annotated Fig. 7A-1). The Examiner also finds that Gill teaches a
second tubular member defining a lumen for accommodating a guide wire,
Id. at 9 (citing Gill ¶¶ 32, 59, annotated Figs. 3B, 7A-1). The Examiner then
determines that one skilled in the art would have considered it obvious, first,
to modify Newell’s pusher band to have a step within its passage for
abutting the end of the first tubular member to prevent it from passing
through the pusher band as taught by Gill, and, second, to modify Newell’s
second tubular member to have a lumen for accommodating a wire guide as
also taught by Gill, “for the purpose of the first tubular member providing
additional support to the pusher band and the inner tubular member to
prevent buckling and crimping during stent deployment (see Gill ¶0036) and
being able [to] guide the delivery device over the guidewire to the correct
treatment site (see Gill ¶0032).” Id. at 9–10.
Appellant presents myriad arguments in response to the Examiner’s
rejection of claim 1. Appeal Br. 17–22. First, Appellant takes issue with
the Examiner’s finding that an “unlabeled” element in Newell corresponds
to the claimed “first tubular member.” Appeal Br. 17–18; Reply Br. 5–6.
According to Appellant, because “there are no reference numbers associated
with the unlabeled portion of FIG. 4A and 4B of Newell and the reference
fails to provide any description in the specification,” the Examiner cannot
reasonably find the unlabeled element “to be a tube.” Reply Br. 6. We
disagree. The figures of a prior art reference can be relied upon where they
clearly show the structure being claimed. In re Mraz, 455 F.2d 1069 (CCPA
1972). Here, the unlabeled element attached to the pusher band, as
identified by the Examiner in Figure 4B, is clearly shown as a tubular
Appeal 2020-005936
Application 14/196,664

6
structure that surrounds a core member (Newell element 760). See Final
Act. 6–7 (annotated Fig. 4B). From that disclosure, one skilled in the art
reasonably would have understood the unlabeled element identified by the
Examiner as meeting the claim element of “a first tubular member.”
Next, Appellant argues that the Examiner’s reliance on the disclosure
of a “hypotube” in paragraph 92 of Newell is “insufficient” to meet the
claimed “second tubular member” because it “is the only mention of a
hypotube . . . and . . . fails to indicate that the core member is tubular.”
Appeal Br. 19. We reject the notion that a “hypotube” is not a tube. Aside
from what the name plainly suggests, Appellant also ignores Newell’s
express definition of core member 760 (which the Examiner equates to the
claimed “second tubular member”) as being of “a solid cross-section,” or
“[a]lternatively, the core member [is] formed from a hypotube.” Newell
¶ 92. That Newell juxtaposes a hypotube against a tube of solid cross-
section clearly supports a finding that the disclosed hypotube is a tubular
structure having a hollow passage. See Ans. 6. Appellant’s assertions to the
contrary are nothing more than conclusory attorney argument. See Appeal
Br. 19 (lacking evidentiary support for what is “known in the art”). Thus,
Appellant does not apprise us of error in the Examiner’s finding that
Newell’s disclosure of the core member being a hypotube meets the claim
element of “a second tubular member.”
Third, even assuming Newell’s disclosure of a hypotube, Appellant
argues that “a hypotube as described by Newell would not be capable of
having a lumen sized for a guidewire” because “[s]tructurally, a hypotube
would be too small.” Appeal Br. 19 (emphasis added). In addition to
lacking evidentiary support, that argument is unpersuasive for the simple
Appeal 2020-005936
Application 14/196,664

7
reason that the Examiner does not rely on Newell for the lumen “being sized
to accommodate a wire guide,” as required by claim 1, but instead relies on
Gill for teaching that feature. See Final Act. 7–9. By failing to address the
rejection as articulated by the Examiner, Appellant does not persuade us that
the Examiner errs in finding that the proposed combination of Newell and
Gill includes a “lumen” as claimed.
Fourth, Appellant surmises that one skilled in the art would have no
reason to modify Newell’s core member 760 to have a lumen and guidewire
as taught by Gill given Newell’s disclosure that the core member “functions
as a guidewire” and “fails to disclose a separate wire” that moves
independent of the core member, then modifying Newell to include Gill’s
additional guidewire “would be redundant.” Appeal Br. 19–21 (citing
Newell ¶¶ 34, 56). We are not persuaded. It is undisputed that Newell’s
core member 760 includes a guide tip that functions to steer the core
member along a path of a vessel. See Newell ¶¶ 34, 56. But the function of
Newell’s guide tip is different from the function of Gill’s guidewire, upon
which the Examiner relies in modifying Newell’s core member. As the
Examiner correctly notes, and Appellant fails to address, one skilled in the
art would recognize the known benefits of improving Newell’s core member
to have a lumen for accommodating a guidewire that moves independently
of, but nonetheless within, the core member. See Ans. 7. Indeed, like
Newell, Gill also includes a guide tip (element 132) bonded to the distal end
of a tubular member, while also including a guidewire that is separately
moveable relative to the tubular member, both of which assist in guiding the
tubular member to the stent deployment site. See Gill ¶¶ 32–34. Thus, we
are persuaded that the record adequately supports the Examiner’s rationale
Appeal 2020-005936
Application 14/196,664

8
that one skilled in the art of stent deployment would have considered it
obvious to improve Newell’s core member with Gill’s teaching of providing
a lumen within the core member to accommodate a guidewire that moves
independently of Newell’s guide tip. See Final Act. 9 (citing Gill ¶ 32, Fig.
7A-1).
Fifth, along the lines of the above argument, Appellant asserts that
Newell describes a so-called “additional ‘guiding catheter,’” which obviates
the need for Newell’s core member to have a lumen for a guidewire, as
taught by Gill, because “it would merely duplicate the guiding catheter’s
function.” Appeal Br. 21 (citing Newell ¶ 5). We disagree. As explained
above, nowhere does Newell disclose that this guiding catheter, which is
described in conjunction with prior art “conventional methods,” is even used
with, let alone necessary to, the embodiment of Newell relied upon by the
Examiner, i.e., that illustrated in Newell’s Figures 4A and 4B. As such, we
are not persuaded of error in the Examiner’s proposed modification of
Newell to incorporate the guidewire lumen taught by Gill.
Finally, Appellant asserts that “Newell fails to disclose or reasonably
suggest that the core member is formed of a polymeric material,” as required
by claim 1. Appeal Br. 21. According to Appellant, because Newell says
that the core member “may merely ‘comprise’ PTFE/Teflon” along its
length or at least at its distal end or tip, one skilled in the art “would
understand that Newell chose the words carefully such that a polymer may
be added to the core member, but not constitute the core member.” Id.
(citing Newell ¶ 92). We disagree. To be clear, Newell provides that “the
core member, along its length or at least at its distal end or tip, can comprise
polytetrafluoroethylene (PTFE or TEFLON.RTM.).” Newell ¶ 92 (emphasis
Appeal 2020-005936
Application 14/196,664

9
added). Fairly read, that passage indicates that either the full length of the
core member or some portion of it may be made of polymeric material. And
because the claim language “being formed from a polymeric material” does
not further elaborate on how the tubular member is made, we agree with the
Examiner’s finding that Newell’s disclosure of core member 760 (the
claimed “second tubular member”) as comprising a polymeric material
meets the recited claim language.
In sum, we have considered Appellant’s arguments, but find them
unpersuasive. See Appeal Br. 17–22; Reply Br. 5–9. Thus, we sustain the
Examiner’s obviousness rejection of claim 1. We also sustain the
Examiner’s rejection of dependent claims 11–17, 20, 21, 25, and 26, which
are not argued separately and fall with claim 1. See 37 C.F.R.
§ 41.37(c)(1)(iv).
2. Newell, Gill, and Dorn and/or Fahey (Claims 2–6 and 18)
Claims 2–6 and 18 depend directly or indirectly from claim 1. In
rejecting these dependent claims, the Examiner relies on teachings from
Dorn and/or Fahey, in addition to the foundational basis of Newell and Gill.
See Final Act. 14–17. Appellant does not raise any new arguments in
response, apart from the arguments “set forth [above] with regard to
claim 1.” See Appeal Br. 29; Reply Br. 13. Thus, for the same reasons
discussed above, we also sustain the Examiner’s rejections of dependent
claims 2–6 and 18.
3. Fahey and Gill (Claims 1, 3, 6, 11–17, 20, 21, and 25–29)
As an alternative basis for rejecting claims 1, 3, 6, 11–17, 20, 21, 25,
and 26, and as the sole basis for rejecting claims 27–29, the Examiner turns
to Fahey, rather than Newell, for teaching substantially all the elements of
Appeal 2020-005936
Application 14/196,664

10
the claims, while still maintaining that Gill teaches the missing claim
elements of: (1) the pusher band having a passage of different cross-
sectional areas to form a step within the pusher band, and (2) the first tubular
member having a distal end that abuts the step of the pusher band. Final
Act. 19–24 (citing Fahey ¶¶ 16, 54–56, 72, Figs. 2, 16; Gill ¶¶ 27, 33, 35,
36, 59, Fig. 7A-1). Also, unlike the Newell-based rejection, the Examiner
finds that Fahey lacks the second tubular member being formed of a
polymeric material, but relies on Gill for that teaching. Id. at 22. As for
why it would have been obvious to modify Fahey’s pusher band (“stop 16”)
and first tubular member (“inner shaft 1”) to incorporate the teachings of
Gill, the Examiner states that one skilled in the art would have done so “for
the purpose of the first tubular member providing additional support to the
pusher band and the inner tubular member to prevent buckling and crimping
during stent deployment.” Id. at 25.
Appellant, in turn, challenges the sufficiency of the Examiner’s reason
for modifying the pusher band (stop 16) of Fahey. See Appeal Br. 22–24;
Reply Br. 10. According to Appellant, incorporating Gill’s teaching into
Fahey would serve no advantage whatsoever because the configuration of
Fahey’s catheter assembly already provides adequate structural support to
prevent crimping and buckling of the second tubular member during stent
deployment. See Appeal Br. 24; Reply Br. 10.
We agree with Appellant. As Appellant correctly notes, Gill teaches
that the first tubular member (middle sheath 124) is positioned within the
pusher band (panchor 128) for the purpose of “function[ing] as a space-
filler” that provides additional structural support “against buckling,
crimping, and other undesired bending and/or collapse” of the second
Appeal 2020-005936
Application 14/196,664

11
tubular member (inner member 122). Id. at 24 (citing Gill ¶ 36). But Fahey
already accomplishes the function of preventing “kinking” and “buckl[ing]”
of the tubular members within its catheter assembly by controlling the
“stiffness” of the first tubular member (inner shaft 1) at its juncture with the
pusher band (stop 16). See Fahey ¶¶ 3, 4, 11–12, 19–20, 51. Fahey does
this by uniquely constructing the inner shaft 1 of “a metallic spiral cut
hypotube 14.” Id. ¶¶ 55, 63. Moreover, in contrast to Gill’s structure, there
is no space or gap to fill between Fahey’s pusher band and second tubular
member 9 because, as shown in Fahey’s Figures 4 and 5, the first tubular
member (hypotube layer 14) surrounds and is in intimate contact with the
second tubular member (guidewire lumen 9), both of which concentrically
surround and mate with the tapered male end of pusher band 16.
In response to Appellant’s argument, the Examiner asserts that
Fahey’s Figures 2, 4, and 5 “disclose that there is some space between the
pusher band 16 and second tubular member 9 and between the first tubular
member 1 and the second tubular member 9,” and that “this arrangement as
a whole” is what would necessitate the benefit described in paragraph 36 of
Gill. Ans. 10–11 (emphasis added). We fail to see how the Examiner
arrives at this conclusion. As discussed above, Fahey’s Figures 4 and 5
depict the stiffer first tubular member (layer 14) and the more flexible
second tubular member (layer 9) in intimate contact with each other, while
surrounding and mating with the tapered male end of pusher band 16. See
Fahey, Figs. 4, 5. Nowhere do those figures depict, or does Fahey otherwise
suggest, the existence of a space or gap between pusher band 16 and tubular
members 9 and 14 in need of extra structural support.
Appeal 2020-005936
Application 14/196,664

12
On a similar note, we reject the notion that Fahey’s “second tubular
member [element 9] is capable of longitudinally sliding relative to the
pusher band [element 16],” as the Examiner seemingly finds. Final Act. 21–
22. Notably, the Examiner fails to provide any evidentiary support for such
a finding. See id. at 21–22 (lacking any citation to the record for finding that
Fahey meets the “slidable” limitation of the claims). That omission stands in
direct contrast to the Examiner’s other findings with respect to Fahey, where
the Examiner provides pin-point citations to the record. See id. at 19–22.
If anything, Fahey discloses that the various parts of the catheter
assembly (inner shaft 1, outer shaft 2, guide tip 8, guidewire lumen 9, and
pusher band 16) move as a unit to the site of desired stent deployment. See
Fahey ¶ 72, Fig. 16. As described, stent 29 is installed between markers 7
and 107, respectively, on Fahey’s pusher band 16 and guidewire lumen 9 for
determining the position of the stent during the delivery procedure. See id.
¶¶ 56, 70, Figs. 2, 16. That the stent sits between positioning markers 7 and
107 reasonably indicates that guidewire lumen 9 is fixed relative to pusher
band 16 so as to facilitate proper advancement of the stent through the body.
See id. ¶ 72. The only disclosure of any of the catheter’s parts being
moveable relative to one another is when outer shaft 2 is withdrawn, while
the other parts remain in place, after the stent is correctly deployed. See id.
¶¶ 55, 72.
In fact, Fahey discloses that the structure of the hypotube members
“provide[s] the assembly with good pushability such that the force applied
by a physician at the proximal end of the assembly is effectively transferred
to the tip.” Id. ¶ 72. In other words, the fact that Fahey’s first and second
tubular members concentrically surround and mate with the tapered male
Appeal 2020-005936
Application 14/196,664

13
end of Fahey’s pusher band provides the very benefit of preventing kinking
and buckling of the tubular members that the Examiner inexplicably believes
is missing from Fahey. And, absent any space or gap within the structure of
Fahey’s pusher band that might contribute to kinking or buckling of the
mating tubular members, we agree with Appellant that one skilled in the art
would have no reason to look to Gill’s teaching of filling such a space or gap
with the end of the first tubular member. Nor does the Examiner adequately
explain why one skilled in the art would so modify Fahey, which already
operates effectively to provide sufficient stiffness and rigidity to the tubular
members where they join with the tapered male end of the pusher band.
Thus, without more, the Examiner’s reason for incorporating Gill’s
teaching into Fahey’s assembly lacks rational underpinning to support a
conclusion of obviousness. As such, we do not sustain the Examiner’s
rejection of independent claims 1, 28, and 29. Nor do we sustain the
rejection of claims 3, 6, 11–17, 20, 21, and 25–27, which depend from
claim 1 and are rejected on the same erroneous basis as claim 1.
4. Fahey, Gill, and Dorn (Claims 2, 4, 5, and 18)
Claims 2, 4, 5, and 18 depend ultimately from claim 1. The Examiner
does not rely on Dorn in any manner that would remedy the above-discussed
deficiency in the Examiner’s rejection of claim 1 based on Fahey and Gill.
See Final Act. 30–31. Thus, we also do not sustain the Examiner’s rejection
of dependent claims 2, 4, 5, and 18 as unpatentable over Fahey, Gill, and
Dorn.
Appeal 2020-005936
Application 14/196,664

14
CONCLUSION
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
27–29 112 Written Description 27–29
1, 11–17,
20, 21, 25,
26
103(a) Newell, Gill 1, 11–17,
20, 21, 25,
26

2–5 103(a) Newell, Gill, Dorn 2–5
3, 6 103(a) Newell, Gill, Fahey 3, 6
18 103(a) Newell, Gill, Fahey,
Dorn
18
1, 3, 6, 11–
17, 20, 21,
25–29
103(a) Fahey, Gill 1, 3, 6,
11–17, 20,
21, 25–29
2, 4, 5, 18 103(a) Fahey, Gill, Dorn 2, 4, 5, 18
Overall
Outcome
1–6, 11–18,
20, 21, 25,
26
27–29

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED IN PART