Ex Parte Guo et al

Patent Trial and Appeal Board

Feb 4, 2015

11910680 (P.T.A.B. Feb. 4, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/910,680 10/04/2007 Xiaoping Guo 0B-046812US 8757
55714 7590 02/05/2015
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION
Kite & Key, LLC
P.O. Box 315
Hamel, MN 55340-0315
EXAMINER
EISENBERG, REBECCA E
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
02/05/2015 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 XIAOPING GUO and RICHARD E. STEHR
____________

Appeal 2012-007509
Application 11/910,680
Technology Center 3700
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1–12, 14–17, 19–
23, and 34–49 (Br. 4).2, 3 Examiner entered rejections under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 The Real Party in Interest is St. Jude Medical, Atrial Fibrillation Division,
Inc. (Br. 2.)
2 “Claims 24–33 stand withdrawn from consideration” (Br. 4).
3 We recognize that Appellants’ statement of the claims on appeal fails to
include pending claim 49 (see Br. 4). Appellants recognize, however, that
claim 49 was rejected over the combination of Ishida and Becker (id. at 8
and 9). In view of the foregoing, we find that Appellants failure to include
claim 49 in the statement of the claims on appeal represents a typographical
error. Therefore, we have included claim 49 as part of our deliberations.
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STATEMENT OF THE CASE
The claims are directed to a body for a catheter or sheath.
Independent claims 1, 14, and 34 are representative and are reproduced in
the Claims Appendix of Appellants’ Brief.
Claims 1–4, 8, 10, 12, 14–16, 19, 21, 23, and 34–49 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over the combination of Ishida4
and Becker.5,6
Claims 9 and 20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ishida, Becker, and Potter.7
Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Ishida, Becker, and Millet.8
Claims 1, 5, 10, 11, 14, 17, 21, and 22 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Solomon9 and Ishida.
Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Solomon, Ishida, and Millet.

4 Ishida et al., US 4,781,690, issued Nov. 1, 1988.
5 Becker et al., US 4,469,483, issued Sept. 4, 1984.
6 We recognize that Examiner separately rejected various claims set forth in
this ground of rejection over either (a) Ishida in view of Becker or (b)
Becker in view of Ishida. We note, however, that “where the relevant
factual inquiries underlying an obviousness determination are otherwise
clear, characterization by the examiner of prior art as ‘primary’ and
‘secondary’ is merely a matter of presentation with no legal significance.”
In re Mouttet, 686 F.3d 1322, 1333 (Fed. Cir. 2012). Therefore, we
consolidated all of Examiner’s various claim rejections over the combination
of Ishida and Becker into a single ground of rejection.
7 Potter et al., US 2004/0267203 A1, published Dec. 30, 2004.
8 Millet, US 6,146,814, issued Nov. 14, 2000.
9 Solomon et al., US 6,200,338 B1, issued Mar. 13, 2001.
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ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose that
The material of the first strip . . . will be sufficiently different
from the material of the second strip . . . so as to form a stress
concentration along the interfacial zones (i.e., borders) . . .
between the two strips . . . . The stress concentration forms a
peel line . . . that acts like a built-in peel grove. As a result, the
tubular body . . . is readily splittable although it lacks an actual
peel groove.
(Spec. ¶ 48.)
FF 2. Ishida suggests
[A] tube for guiding rod-like medical instruments into a living
body, comprising:
a main body provided with a longitudinal slit and formed
of a mixture of first and second materials; and
a stripe-shaped member (referred to hereinafter as
“stripe”) embedded liquid-tight in the slit of the main body and
formed of a third material;
said first material being substantially incapable of
bonding to the third material, and said second material
exhibiting a high bonding strength to the third material such
that the stripe can be readily detached from the slit of the main
body by application of a predetermined force to allow the
guiding tube to be removed from the medical instrument after
introduction of the medical instrument through the guiding
tube.
(Ishida, col. 2, ll. 17–32; see generally Ans. 4, 6, and 11).
FF 3. An object of Ishida’s invention “is to provide a guiding tube . . .
which is free from accidental splitting or cracking” (id. at col. 2, ll. 8–11).
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FF 4. Ishida’s Figures 4 and 9 are reproduced below:

“FIG. 4 is an oblique view showing a guiding tube for medical instruments
according to one embodiment of . . . [Ishida’s] invention” (Ishida, col. 2, ll.
51–53). “FIG. 5 is a cross-sectional view along line II—II of FIG. 4” (id. at
ll. 54–55).
FF 5. Ishida’s guiding tube 11
[C]omprises a main body 13 formed of a mixture of the first
and second materials and . . . [at least one] stripe 14 formed of a
third material. The main body 13 is substantially in the shape
of a hollow tube provided with a longitudinal slit 12, and the
stripe 14 is embedded in the slit 12 of the main body 13.
(Ishida, col. 3, ll. 1–6; id. at col. 4, ll. 26–28 (“it is also possible to provide a
plurality of stripes 14 as shown in FIG. 9”); see generally Ans. 4, 6, and 11.)
FF 6. Ishida suggests that
After the catheter has been secured to the blood vessel . .
. the guiding tube 11 is removed from the catheter. In removing
the guiding tube 11, the stripe 14 is pulled outward . . . with the
result that the stripe 14 is removed so as to expose the slit 12 of
the main body 13 . . . . Naturally, the exposed slit 12 permits
the guiding tube 11 to be readily removed from the catheter 15.
(Ishida, col. 4, ll. 13–20; see generally Ans. 4.)
FF 7. Examiner finds that Ishida fails to suggest a “first strip ha[ving] a
radiopacity higher than the second” and relies on Becker to make up for this
deficiency in Ishida (Ans. 4–5).
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FF 8. Becker “relates to . . . catheter designs utilizing radiopaque
materials” (Becker, col. 1, ll. 5–7).
FF 9. Becker’s Figures 1 and 3 are reproduced below:

“FIG. 1 is a transverse sectional view . . . of catheter tubing” (id. at col. 3, ll.
16–18). “FIG. 3 is a transverse sectional view” of a catheter, wherein
catheter tubing 20 comprises (1) a longitudinal stripe 12a which contain a
radiopaque material such as barium sulfate and (2) a transparent longitudinal
segment 14a (id. at col. 3, ll. 20–22 and col. 5, ll. 5–19).
FF 10. Becker suggests that “while the catheter is visible to x-rays by
radiopaque stripes 12, the contents and interior of the catheter can also be
viewed through clear segments 14” (id. at col. 3, ll. 44–46).
FF 11. Becker suggests that “upon stretching of the cured catheter most of
the stress is carried by sections 14, thus protecting stripes 12 from rupturing,
and permitting higher loadings of barium sulfate to provide greater x-ray
visibility” (Becker, col. 4, ll. 48–51).
FF 12. Examiner finds that Becker “fails to teach a splittable area along an
interfacial zone between the first and second strips” (Ans. 6).
FF 13. Examiner finds that the combination of Ishida and Becker fails to
suggest a first polymer comprised of tungsten and relies on Potter to make
up for this deficiency (Ans. 9–10).
FF 14. Examiner finds that the combination of Becker and Ishida fails to
suggest strips “in a helical pattern” and relies on Millet to make up for this
deficiency in the combination of Becker and Ishida (Ans. 12; see also id.
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(Examiner finds that the combination of Solomon and Ishida fails to suggest
strips “in a helical pattern” and relies on Millet to make up for this
deficiency in the combination of Solomon and Ishida)).
FF 15. Solomon
[R]elates to a radiopaque tubing comprising a visually
transparent radiopaque polymer and a radiopaque filler material
useful as a medical implant such as a catheter . . . . In one
embodiment, the visually transparent radiopaque polymer
comprises a polyurethane including a diisocyanate, a polyol,
and a chain extender, which contain between 10–30% by
weight bromine concentration. The filler material contains a
radiopaque agent which may be, for example, barium sulfate . .
. tungsten or other material.
(Solomon, col. 3, ll. 6–15.)
FF 16. Solomon’s Figures 3 and 4 are reproduced below:

FIGs. 3 and 4 illustrate “cross sections of the tubing of alternative
embodiments of [Solomon’s] . . . invention” (id. at col. 2, ll. 61–62).
FF 17. Solomon suggests that
While providing the advantage of substantial increases in
radiopacity, when combined with the polymer, the filler
material [40] in the resulting tubing of the invention will tend to
limit optical transparency of the polymer. This can be
overcome through various embodiments which provide at least
one window of visually transparent radiopaque polymer [10],
which is free of filler material, co-extruded to produce an
optically or visually clear cross-sectional segment of the tubing.
(Id. at col. 3, ll. 41–52.)
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FF 18. Examiner finds that Solomon fails to suggest “a splittable area along
an interfacial zone between the first and second strips” and relies on Ishida
to make up for this deficiency in Solomon (Ans. 10–11).
ANALYSIS
The combination of Ishida and Becker with or without Potter or Millet:
Claim 1:
The catheter or sheath body of Appellants’ claim 1 comprises, (1)
proximal and distal portions and (2) at least a first and second longitudinal
strip, wherein the strips extend generally between the proximal and distal
portions and form a wall that is continuous and integral along substantially
an entire length and about substantially an entire perimeter of the body while
being splittable along an interfacial zone between the first and second strips,
and the first strip has a radiopacity that is higher than the second strip (see
Appellants’ claim 1). The body for a catheter or sheath set forth in
Appellants’ claim 1 encompasses tubular body that includes more than 2
strips and does not exclude the presence of one or more strips that exhibit a
higher bonding preference for one strip relative to another (see Appellants’
claim 1; FF 1).
Ishida suggests a tubular body comprising a main body with a
longitudinal slit, wherein the main body is formed of a mixture of first and
second materials (FF 2; Cf. FF 1). Ishida’s tubular body further comprises a
stripe, formed of a third material, which is “embedded liquid-tight in the
slit” (FF 2). Ishida suggests that the first material is “substantially incapable
of bonding to the third material,” while the second material exhibits “a high
bonding strength to the third material such that the stripe can be readily
detached from the slit of the main body by application of a predetermined
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force to allow the guiding tube to be removed from the medical instrument”
(FF 2; Cf. FF 1). Therefore, Ishida suggests Appellants’ claimed invention
but for the presence of a strip that has a radiopacity that is higher than a
second strip (FF 7; see also FF 2–6). This deficiency in Ishida, however, is
made up for by Becker, which suggests at least two strips, wherein one strip
is transparent and the other strip contains a radiopaque material (FF 8–11).
Further, while Becker “fails to teach a splittable area along an interfacial
zone between the first and second strips,” Ishida makes up for this
deficiency in Becker (see FF 12; Cf. FF 2–6). Therefore, based on the
combination of Ishida and Becker, Examiner concludes that, at the time
Appellants’ invention was made, it would have been prima facie obvious to
make one of the strip materials suggested by Ishida radiopaque as suggested
by Becker “in order to allow for easy visualization during insertion with the
use of CT scans or ultrasounds” (Ans. 5). We find no error in Examiner’s
prima facie case of obviousness.
Ishida, like Becker, is interested in providing “a guiding tube . . .
which is free from accidental splitting or cracking” (FF 3; Cf. FF 11). In this
regard, Ishida suggests a device that is not splittable until a predetermined
force is applied to the third strip so as to separate the third and first strips
along the interfacial zone between the first and third strips (FF 2 and 4–6).
Therefore, we are not persuaded by Appellants contentions regarding
Becker’s failure to suggest a splittable device, which fail to account for
Ishida’s contribution to the combination relied upon by Examiner (see Br.
10–11).

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Claim 7:
Claim 7 depends from and further limits claim 1 to require that the
first and second longitudinal stripes are helical along the body (see
Appellants’ claim 7).
Based on the combination of Ishida, Becker, and Millet, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to have included the helical stripes of Millet in
order to allow for easier viewing of the catheter during use” (Ans. 12).
Having found no error in Examiner’s combination of Ishida and
Becker as it relates to Appellants’ claim 1, we are not persuaded by
Appellants contention that Millet fails to make up for the alleged
deficiencies in the combination of Ishida and Becker (Br. 13).

Claim 9:
Claim 9 depends from and further limits claim 1 to require the first
longitudinal strip is formed from a first polymer, wherein the first polymer
comprises at least one polymer and tungsten (see Appellants’ claim 9).
Based on the combination of Ishida, Becker, and Potter, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to have made the polymer tungsten in order to
have a specified level of glow during in-vivo use” (Ans. 9 and 10; FF 13).
Appellants do not contest Examiner’s rejection of claim 9. Therefore,
we summarily affirm the rejection of claim 9 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ishida, Becker, and Potter.

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Claim 12:
Appellants’ claim 12 depends ultimately from and further limits claim
1 to require “the first longitudinal strip comprises between approximately
1% and approximately 5% of the circumference of the tubular body” (see
Appellants’ claim 12).
Based on the combination of Ishida and Becker, Examiner concludes
that, at the time Appellants’ invention was made, it would have been prima
facie obvious to construct the device of Ishida and Becker to comprise a first
longitudinal strip that comprises between approximately 1% to
approximately 5% of the circumference of the tubular body, “since it has
been held that where the general conditions of a claim are disclosed in the
prior art, discovering the optimum or workable ranges involves only routine
skill in the art” (Ans. 13, citing In re Aller, 220 F.2d 454, 456 (CCPA
1955)).
Having found no deficiency in Examiner’s rejection of claim 1, we are
not persuaded by Appellants contention that Examiner’s rejection of claim
12 is in error for the reasons presented with regard to Appellants’ claim 1
(see Br. 13).

Claim 14:
The catheter or sheath body of Appellants’ claim 14 comprises, inter
alia, a first and second segment each having a radiopacity, wherein the
radiopacity of the first segment is higher than a radiopacity of the second
segment (see Appellants’ claim 14).
Examiner finds that Ishida fails to suggest a “first strip ha[ving] a
radiopacity higher than the second” and relies on Becker to make up for this
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deficiency (FF 7). In this regard, Examiner relies on Becker’s FIG. 1 to
suggest “a third and fo[u]rth longitudinal strip[],” wherein “the third ha[s] a
higher radiopacity th[a]n the fo[u]rth” (Ans. 6). Becker’s FIG. 1, however,
fails to support a conclusion that either of the radiopaque strips 12 has a
higher radiopacity than the other as asserted by Examiner (see Ans. 12; FF
9). Contrary to Examiner’s assertion, Becker distinguishes radiopaque strips
12, which are visible to x-rays, from strips 14, which are characterized as
clear segments (see FF 10). In sum, Examiner failed to establish an
evidentiary basis on this record to support a conclusion that the combination
of Ishida and Becker suggests the subject matter of Appellants’ claim 14.

Claim 20:
Claim 20 depends from and further limits claim 14 to require that the
first segment is formed from at first polymer and the second segment is
formed from a second polymer, where in the first polymer comprises
tungsten (see Appellants’ claim 20). Examiner failed to establish that Potter
makes up for the foregoing deficiency in the combination of Ishida and
Becker (see FF 13).

Claim 23:
Appellants’ claim 23 depends ultimately from and further limits claim
14 to require that “the first segment comprises between approximately 1%
and approximately 5% of the circumference of the wall cross-section” (see
Appellants’ claim 23). Examiner, however, failed to establish that the
combination of Ishida and Becker suggests a first and second segment each
having a radiopacity, wherein the radiopacity of the first segment is higher
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than a radiopacity of the second segment as is required by Appellants’ claim
23.

The combination of Solomon and Ishida with or without Millet:
Claim 1:
The requirements of Appellants’ claim 1 are discussed above.
Solomon suggests a tubular body comprising at least two strips having
different degrees of radiopacity (FF 15–18). The rationale for the
combination of Solomon and Ishida is substantially the same as that set forth
above for the combination of Ishida and Becker. Therefore, based on the
combination of Solomon and Ishida, Examiner concludes that, at the time
Appellants’ invention was made, it would have been prima facie obvious “to
have made the polymer wherein the body is peelable at an interface between
the first and second longitudinal strips without the employment of a peeling
groove in order to maintain structural integrity as well as to allow for easy
access to the interior of the catheter” (Ans. 12).
Appellants contend that “[l]ike Becker . . ., Solomon does not teach a
splittable body [and] is concerned with the integrity of the body” (Br. 12).
We are not persuaded for the same reasons set forth above with respect to
the combination of Ishida and Becker. Therefore, we are not persuaded by
Appellants’ contention that “the [c]ombination of Solomon and Ishida . . .
fails to render the present invention prima facie obvious” for the reasons set
forth above with respect to the rejection over the combination of Ishida and
Becker (see id.).

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Claim 6:
Claim 6 depends ultimately from claim 1 and further requires that “the
first and second longitudinal strips are helical along the body” (see
Appellants’ claim 6). Based on the combination of Solomon, Ishida, and
Millet, Examiner concludes that, at the time Appellants’ invention was
made, it would have been prima facie obvious “to have included the helical
stripes of Millet in order to allow for easier viewing of the catheter during
use” (Ans. 12; see FF 14).
Having found no error in Examiner’s combination of Solomon and
Ishida as it relates to Appellants’ claim 1, we are not persuaded by
Appellants contention that Millet fails to make up for the alleged
deficiencies in the combination of Solomon and Ishida (Br. 12–13).
CONCLUSION OF LAW
The rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Ishida, Becker, and Potter is summarily affirmed.
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to claims 1 and 12 over the
combination of Ishida and Becker. The rejection of claims 1 and 12 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of
Ishida and Becker is affirmed. Because they are not separately argued,
claims 2–4, 8, 10, and 34–49 fall with claim 1.
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to claim 7 over the combination of
Ishida, Becker, and Millet. The rejection of claim 7 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Ishida, Becker, and Millet
is affirmed.
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The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to claim 1 over the combination of
Solomon and Ishida. The rejection of claim 1 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Solomon and Ishida is affirmed.
Because they are not separately argued claims 5, 10, 11, 14, 17, 21, and 22
fall with claim 1.
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to claim 6 over the combination of
Solomon, Ishida, and Millet. The rejection of claim 6 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Solomon, Ishida, and
Millet is affirmed.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to claims 14–16, 19, 21,
and 23 over the combination of Ishida and Becker. The rejection of claims
14–16, 19, 21, and 23 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Ishida and Becker is reversed
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to claim 20 over the
combination of Ishida, Becker, and Potter. The rejection of claim 20 under
35 U.S.C. § 103(a) as unpatentable over the combination of Ishida, Becker,
and Potter is reversed.
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).

AFFIRMED-IN-PART
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