Cathera, Inc.

Patent Trials and Appeals Board

Jul 30, 2021

2021000258 (P.T.A.B. Jul. 30, 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.
14/852,268 09/11/2015 Elaine Lim A0000489US01/1213-070US01 9108
137834 7590 07/30/2021
MDT_RTGNV/Shumaker & Sieffert P.A.
Attn: IP Legal Department
826 Coal Creek Circle
Louisville, CO 80027
EXAMINER
FREDRICKSON, COURTNEY B
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
07/30/2021 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):
pairdocketing@ssiplaw.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELAINE LIM and TING TINA YE
Appeal 2021-000258
Application 14/852,268
Technology Center 3700
Before DANIEL S. SONG, STEFAN STAICOVICI, and
EDWARD A. BROWN, Administrative Patent Judges.
SONG, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant appeals from the
Examiner’s decision to reject claims 1–3, 8–13, 18–24, and 26–43.1 We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). The Appellant identifies Medtronic plc as the real party in
interest. Appeal Br. 3. Claims 4 and 25 have been canceled by the
Appellant. Amendment p. 8 (Jan. 21, 2020).
Appeal 2021-000258
Application 14/852,268

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CLAIMED SUBJECT MATTER
The claims are directed to a catheter. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A catheter, comprising:
an elongated shaft having a proximal portion and a distal
portion, wherein an inner surface of the elongated shaft defines a
lumen that extends distally from the proximal portion to an
opening at a distal terminus of the distal portion;
where the distal portion includes:
an inner polymer structure;
an outer polymer structure disposed around the
inner polymer structure; and
a coil wound around the inner polymer structure and
disposed within the outer polymer structure,
wherein the coil includes a first region having a first
pitch, a second region distal to the first region and having
a second pitch, and a third region distal to the second
region and having a third pitch,
wherein the first pitch and the third pitch are each
tighter than the second pitch,
wherein no adjacent turns of the coil contact each
other in the first region, the second region, or the third
region, and
wherein the third pitch is between about 0.004
inches and about 0.014 inches.
Appeal Br. 26 (Claims App.) (paragraphing added).
OPINION
The Examiner rejects claims 1–3, 8–13, 18–24, and 26–43 under
35 U.S.C. § 103 as being unpatentable over McFerran (US 2006/0089618
A1; pub. Apr. 27, 2006) in view of Berg (US 5,911,715; iss. June 15, 1999).
Final Act. 5. As to independent claim 1, the Examiner finds McFerran
discloses a catheter substantially as claimed, but fails to disclose a third
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Application 14/852,268

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region with a third pitch that is tighter than a second pitch of a second
region. Final Act. 6. However, the Examiner finds that the Appellant’s
Specification “provides no criticality for the claimed coil configuration,” and
that McFerran “discloses that the pitch of the coil may be varied to change
the flexibility of the catheter.” Final Act. 6 (citing McFerran ¶ 28). The
Examiner also finds that Berg teaches that:
it is obvious to tailor the flexibility of specific regions of the
catheter to improve the catheter performance for a specific
procedure [and] further teaches a catheter having a first, second
and third region in which the first and third regions are less
flexible than the second region.
Final Act. 6–7 (citing Berg, col. 1, ll. 21–25, col. 11, ll. 4–18, Fig. 5).
Based on the above findings, the Examiner concludes that:
Since McFerran teaches that the pitch of the coil can be varied
to achieve a desired flexibility profile and Berg teaches that it is
obvious to select regions of the catheter to have a specific
amount of flexibility, it would have been obvious to one of
ordinary skill . . . to have modified the catheter of McFerran to
have the first pitch and the third pitch [that] are each tighter
than the second pitch for the purpose of providing a catheter
which improves catheter performance as desired for specific
procedures in a specific region.
Final Act. 7–8 (citing Berg, col. 11, ll. 4–7) (“[I]t would have been obvious
to one of ordinary skill in the art . . . to have optimized the pitch of the coil
for the purposes of providing a catheter shaft with a desired flexibility within
a particular region of the catheter shaft.”).
The Appellant argues against the rejection, arguing various claims in
different groups. Appeal Br. 8; see also 37 C.F.R. 41.37(c)(1)(iv). We
agree with the Examiner’s findings and conclusion, and address the
Appellant’s arguments directed to these groups infra.
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Application 14/852,268

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Group 1: Claims 1–3, 8–12, 21, and 35–392
The Appellant initially points out that in addition to disclosing
variation in the pitch of the wire coil layers to impart greater flexibility,
McFerran also discloses outer layer segments of differing durometers to
modify stiffness of the catheter. Appeal Br. 10 (citing McFerran ¶ 21, 22,
26, 27, Fig. 2); see also Reply Br. 3. The Appellant also points out that Berg
teaches that “the outer tube 16 includes discrete segments that provide
varying flexural modulus to the catheter.” Appeal Br. 10 (citing Berg, col.
2, ll. 51–57; col. 6, ll. 1–12). Accordingly, the Appellant asserts that in
modifying McFerran’s catheter, a person of ordinary skill in the art “would
have modified the analogous structure to the Berg outer tube 16: McFerran’s
outer layer segments 38, 40, 42, and 48,” instead of modifying the wire coil
layer 68, which would not result in the invention of claim 1. Appeal Br. 10–
11; see also Reply Br. 2–4.
We are not persuaded by the Appellant’s argument. The fact that
McFerran also discloses an alternate manner of modifying the flexibility of
the catheter does not detract from, or otherwise diminish, its teaching that
coil pitch can be used to modify the flexibility of the catheter. McFerran
specifically teaches that:
While two coil segments are specifically depicted in the
embodiment of FIG. 2, it should be understood that a greater or
lesser number of coil segments can be provided. . . [T]he pitch
of the coils can also be varied to alter the performance
characteristics of the catheter 10. . . . [F]or example, the coil
pitch of the coils 68 forming the second coil segment can be
made greater than the coil pitch of the coils 64 forming the first

2 The Appellant also identifies claims 5–7 as being within this group, but we
observe that claims 5–7 are not part of this appeal.
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coil segment, thus imparting a greater amount of flexibility to
the distal portion of the catheter 10.
McFerran ¶ 28. Accordingly, the Examiner is correct that McFerran
suggests “providing coils segments at more discrete intervals and varying
the pitch of the coil to achieve a certain flexibility profile.” Ans. 18.
The rejection also relies on Berg, not for its mechanism for varying
flexibility to a catheter, but instead, its broader teaching that the flexibility
of a catheter can be varied so as to “improve[] catheter performance as
desired for specific procedures in a specific region,” and also for
establishing that the first and third regions may be made less flexible than
the second region. Final Act. 6–7. Indeed, Berg specifically teaches that the
flexibility of segments are selected to:
match identified functions of the particular segment of the
catheter shaft in specific intravascular procedures. Unlike prior
art catheters, this preferred design incorporating distinct
segments, does not necessarily follow the current standard of
each section of a catheter becoming more flexible as you move
proximal to distal along a catheter shaft. Thus, each discrete
segment of the catheter shaft of the present embodiment is
matched to its clinical role and function.
Berg, col. 2, ll. 52–63. Accordingly, the Examiner is correct that “Berg
teaches that it is known to selectively alter the flexibility of the catheter in
discrete regions []and further teaches a specific configuration in which a first
and third region have greater flexibility than the second region.” Ans. 18–19
(citing Berg, col. 2, ll. 52–57; col. 10, ll. 15–18).
The Appellant’s assertion that a person of ordinary skill would have
only found it obvious to modify the outer layer segments to alter catheter
flexibility is unpersuasive because the Appellant improperly views a person
of ordinary skill as an automaton that merely bodily incorporates the applied
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prior art rather than a person of ordinary skill. KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 421 (2007) (“A person of ordinary skill is also a person of
ordinary creativity, not an automaton.”).
The Appellant also responds that the Examiner is not “considering the
references as a whole, including parts of the references that teach away from
the proposed combination.” Reply Br. 2. However, we discern nothing in
the teachings of McFerran and/or Berg that teaches away from the proposed
combination of the rejection. As discussed above, the rejection relies on
Berg for the broader disclosure of a catheter having regions of different
flexibilities to “improve catheter performance for a specific procedure,” and
McFerran’s teachings with respect to coil pitch to implement such different
flexibilities along the catheter. The fact that McFerran discloses two
different ways to alter flexibility does not detract from its disclosure with
respect to altering coil pitch and its establishment that this technique of
changing flexibility of portions of a catheter is well-known in the art. In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“[T]he prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from any of these alternatives because such disclosure does not criticize,
discredit, or otherwise discourage the solution claimed.”).
The Appellant also argues that the rejection relies on impermissible
hindsight because the rejection uses the Appellant’s Specification as a
roadmap. Appeal Br. 11. However, as evident from the above discussion,
because the Examiner relies on teachings provided in McFerran and Berg,
and does not rely on teachings only found in the Appellant’s disclosure, we
are not persuaded that the rejection engages in impermissible hindsight. See
In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (hindsight argument
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is of no moment where the Examiner provides a sufficient, non-hindsight
reason to combine the references).
The Appellant further argues that contrary to the Examiner’s
assertions as to different wire coil regions and pitches, “McFerran does not
disclose or suggest any regions with different pitches within the single wire
coil layer 68.” Appeal Br. 11. In that regard, the Appellant argues that
“[t]he Examiner’s division of McFerran’s single wire coil layer 68 into three
regions is completely arbitrary and unsupported by McFerran,” and that
“even if ‘portions can be delimited from McFerran,’ this does not mean that
portions are in fact delimited in McFerran or that such portions are
suggested by McFerran.” Appeal Br. 12; see also Reply Br. 4.
These arguments are unpersuasive. As the Examiner points out, “the
claim does not further define the regions of the distal portion.” Ans. 19. In
other words, the recited first, second, and third regions are only delineated
from each other by their relative positions and pitches. No other structural
feature or dimension are recited with respect to the recited regions.
Accordingly, as the Examiner explains, “portions can be delimited from
McFerran to meet the claimed limitation” based on desired flexibility or
performance characteristics of the catheter in view of McFerran’s teaching
that greater number of coil segments can be provided, and that “the pitch of
the coils can also be varied to alter the performance characteristics of the
catheter,” as well as Berg’s teaching that flexibility of segments are selected
to “match identified functions of the particular segment of the catheter shaft
in specific intravascular procedures.” Ans. 19; see also McFerran ¶ 28;
Berg, col. 2, ll. 52–57.
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Finally, the Appellant further argues that “McFerran does not disclose
or suggest a more distal region with a lower flexibility than a more proximal
region.” Appeal Br. 11. However, the Appellant’s argument argues
McFerran individually and is misdirected because the rejection relies on
Berg for this limitation, Berg teaching that “[u]nlike prior art catheters, this
preferred design incorporating distinct segments, does not necessarily follow
the current standard of each section of a catheter becoming more flexible as
you move proximal to distal along a catheter shaft,” thereby disclosing or a
more distal region with a lower flexibility than a more proximal region.
Berg, col. 2, ll. 57–61.
Therefore, we are not persuaded of Examiner error, and affirm the
rejection of claim 1, as well as of claims 2, 3, 8–12, 21, and 35–39.3

Group 2: Claim 37
Claim 37 depends from claim 1 and recites that “a proximal terminus
of the coil is at an intermediate region of the distal portion of the elongated
shaft.” Appeal Br. 32 (Claims App.). The Examiner finds that “McFerran
discloses a proximal terminus of the coil is at an intermediate region of the
distal portion of the elongated shaft.” Final Act. 18 (citing McFerran ¶ 27,
annotated Fig. 2).
The Appellant relies on dependency on claim 1 for patentability.
Appeal Br. 12. However, this reliance on claim 1 is not dispositive because,
as discussed above, we are not persuaded that the Examiner erred in
rejecting claim 1.

3 Claim 37 is also separately argued as Group 2, which is addressed below.
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Application 14/852,268

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The Appellant also argues that “McFerran does not describe that the
three wire coil layers 64 and the single coil layer 68 are separate coils,” but
instead, describes first coil segment corresponding to wire coil layers 64 and
second coil segment corresponding to wire coil layer 68. Appeal Br. 12.
Thus, according to the Appellant, “[t]he Examiner has not established that
these coil segments are separate coils such that the proximal terminus of the
single wire coil layer 68 is at the location indicated by the Examiner in
annotated Figure 2.” Appeal Br. 13.
We do not find the Appellant’s argument persuasive. On the whole,
McFerran’s disclosure treats coils 64 and 68 as separate and distinct coils.
For example, different reference numerals and nomenclature are utilized by
McFerran, namely, “three wire coil layers 64” and “single wire coil layer
68.” McFerran ¶¶ 64, 68. In discussing these wire coil layers, McFerran
teaches that “[a]s with the wire coil layers 64 forming the first coil segment,
the single wire coil layer 68 can be encased entirely within the outer layers
40,48 of the intermediate and distal shaft sections 16,18.” McFerran ¶ 26.
As the Examiner points out, “McFerran explicitly separates the coil 64 and
68 as two distinct segments,” and “further discloses that the second coil
segment 68 extends distally from location 66, which is shown to be in an
intermediate region of the distal portion.” Ans. 20. In that regard, location
66 is not identified as a location along the wire coil layer, but instead, along
its intermediate shaft section 16 of the catheter. McFerran ¶ 27, Fig. 2.
Therefore, we agree with the Examiner’s finding, and affirm the
rejection of claim 37.
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Groups 3–7
As to Groups 3–7, the Appellant relies on dependency and/or sets
forth substantially the same arguments addressed above relative to Groups 1
and 2 in support of patentability of claims 13, 18–20, 22–24, 26–34, and 40–
43. Appeal Br. 15–25. The Examiner likewise repeats substantively the
same responses as set forth relative to Groups 1 and 2. Ans. 21–26.
Therefore, we affirm the rejections of claims 13, 18–20, 22–24, 26–34, and
40–43 for substantially the same reasons discussed above relative to Groups
1 and 2.
CONCLUSION
The Examiner’s rejection is affirmed.
DECISION SUMMARY
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 8–13,
18–24, 26–
43
103 McFerran, Berg 1–3, 8–13,
18–24, 26–
43

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED