Ex Parte Guo et al

Patent Trial and Appeal Board

Mar 27, 2013

11967219 (P.T.A.B. Mar. 27, 2013)

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.
11/967,219 12/30/2007 Xiaoping Guo 0B-055000US/82410-0224 6505
55962 7590 03/28/2013
SJM/AFD-WILEY
Kite & Key, LLC
P.O. Box 315
Hamel, MN 55340-0315
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
03/28/2013 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, DAVID P. JOHNSON,
and RICHARD E. STEHR
__________

Appeal 2011-005748
Application 11/967,219
Technology Center 3700
__________

Before TONI R. SCHEINER, STEPHEN WALSH, and ULRIKE W. JENKS,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 26 and 28-33, directed to a catheter shaft. The claims have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claims 26 and 28-33 are pending and on appeal. Claims 1-25 are also
pending, but have been withdrawn from consideration; claim 27 has been
canceled (App. Br. 4).
Claims 26 and 29 are representative:
26. A catheter shaft formed according to a method comprising the
steps of:
forming an inner layer of a first material;
forming a first wire reinforcing layer about the inner layer, the first
wire reinforcing layer comprising one or more wires helically wound in a
first direction;
forming an intermediate layer of a second material about the first wire
reinforcing layer;
forming a second wire reinforcing layer about the intermediate layer,
the second wire reinforcing layer comprising one or more wires helically
wound in a second direction opposite the first direction; and
forming an outer layer of a third material about the second wire
reinforcing layer,
wherein the second material has a lower flexural modulus and a
higher yield strain than at least one of the first material and the third
material.

29. A catheter shaft, comprising:
an inner layer of a first material;
an intermediate layer of a second material, the intermediate layer
being bonded to the inner layer;
an outer layer of a third material, the outer layer being bonded to the
intermediate layer;
a first wire reinforcing layer encapsulated by at least one of the inner
layer and the intermediate layer; and
a second wire reinforcing layer encapsulated by at least one of the
outer layer and the intermediate layer,
wherein the first wire reinforcing layer comprises a first wire helically
wound in a first direction and the second wire reinforcing layer comprises a
second wire helically wound in a second direction opposite the first
direction.
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The Examiner rejected claims 26 and 28-33 under 35 U.S.C. § 103(a)
as unpatentable over Samson (US 5,891,112, April 6, 1999).
In addition, the Examiner rejected claims 26 and 28-33 under 35
U.S.C. § 103(a) as unpatentable over Samson in view of Davila et al. (US
5,851,464, December 22, 1998).
Finally, the Examiner has maintained a rejection of claims 26 and 29
on the ground of nonstatutory obviousness-type double patenting over
claims 1 and 16 of Application No. 11/618,570 (now US Patent 8,812,466).
We reverse both obviousness rejections with respect to claims 26, 28,
30, and 31, and affirm with respect to claims 29, 32, and 33. In addition, we
affirm the double patenting rejection of claims 26 and 29.
FACT FINDINGS
1. According to the Specification,
[T]he present invention provides a method of manufacturing a
catheter shaft generally including the following steps: forming
an inner polymeric layer (“inner layer”); forming a first
metallic-wire reinforcing layer (“first reinforcing layer”) about
the inner layer, the first reinforcing layer including one or more
wires helically wound in a first direction at a first winding
angle; forming an intermediate polymer layer (“intermediate
layer”) about the first reinforcing layer; forming a second
metallic-wire reinforcing layer (“second reinforcing layer”)
about the intermediate layer, the second reinforcing layer
including one or more wires helically wound in a second
direction at a second winding angle; and forming an outer
polymeric layer (“outer layer”) about the second reinforcing
layer, wherein the first direction is different from the second
direction.
(Spec. ¶ 8.)

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2. The Specification discloses that:
The lower flexural modulus and higher yield strain of
intermediate layer 30 relative to inner layer 26 and/or outer
layer 34 advantageously promotes maneuverability of catheter
shaft 12. It is also desirable for intermediate layer 30 to have a
lower durometer than at least one of, and preferably both of,
inner layer 26 and outer layer 34. Preferably, intermediate layer
30 is made of a hyperelastic polymer material[.]
(Spec. ¶ 43.)
The Specification further teaches that “intermediate layer 30 may be
hyperelastic relative to at least one, and preferably both of, inner layer 26
and outer layer 34. In addition, first and second reinforcing layers 28, 32 are
wound in opposite directions” (Spec. ¶ 53). According to the Specification,
“[t]hese features advantageously permit a catheter shaft . . . to effectively
undertake bidirectional torques and axial forces with improved kink
resistance and mechanical integrity, even when the catheter shaft is under
flexural loading” (id.).
3. Figure 7 of Samson is reproduced below:

Figure 7 of Samson depicts “catheter assembly (240) [which] uses a
proximal section (242) made up of a number of layers . . . including an inner
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braid (244) and an outer braid (246)” (Samson, col. 13, ll. 40-42). An “inner
liner member (250) coextends, is coaxial with, and is internal to the inner
braid (244). A middle layer of a polymeric tubing (254) extends from the
proximal end of the catheter to the distal end and forms the distal portion
(252) of that catheter assembly” and “[a] further outer covering (256) covers
braid (246)” (id. at col. 13, ll. 45-50).
4. Samson teaches that:
The more basic forms of braids used in this invention include
those which are made up of an even number of equally sized
ribbons. Half of the ribbons are woven in a clockwise direction
(as viewed along the axis of the braid) and the remaining half of
the ribbons are woven in a counterclockwise direction. . . .[T]he
sum of the ribbons used in a particular direction should equal
those wound in the other direction. Any imbalance will
typically cause a helical curl in the resulting catheter.
(Samson, col. 8, ll. 5-14.)
5. According to Samson, “[t]he kink resistance of the catheter
section is due to the presence of the braid” (Samson, col. 8, ll. 25-26).
6. Davila discloses a catheter shaft comprising three layers:
[I]nner layer 24, an outer layer 26 and a middle layer 28 . . . are
all made from . . . polymers. The inner and outer layers are
preferably made from what is sometimes referred to by those
skilled in the art as a semi-rigid polymer. Examples of these
include: polyamides, polyamide elastomers, copolymers based
on polyamides such as Pebax 7033 . . . , high-density
polyethylene, rigid polyurethane, and polypropylene.
(Davila, col. 3, ll. 12-20.)
The middle layer is made from a polymer which is more flexible
and has a lower melt temperature than the inner and outer
layers. Examples of suitable materials for middle layer 28
include: low-durometer polyurethane, low density polyethylene,
maleated polyolefins such as Plexar® . . . , nylon elastomers,
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Pebax 2533® . . . , copolymers of nylon-ll and other
polyamides.
(Id. at col. 3, ll. 24-32 (emphasis added).)
7. Davila teaches that “[m]iddle layer 28 may also include a
reinforcing braid wire imbedded therein” (Davila, col. 3, ll. 45-46).
OBVIOUSNESS - SAMSON
Samson
Claims 26 and 28-33 stand rejected as unpatentable over Samson.
The Examiner finds, in relevant part, that Samson discloses a multiple
layer catheter shaft comprising:
[A]n inner layer 250 made of a first material, a first wire
reinforcing layer 244 about the inner layer made of helically
wound wires, an intermediate layer 254 made of a second
material about the first wire reinforcing layer, a second wire
reinforcing layer 246 helically wound and an outer layer 256
made of a third material about the second wire reinforcing
layer. The reinforcing layers are disclosed as being ribbons half
of which are wound in one direction and half of which are
wound in the opposite direction[.]
(Id. at 3.)
The Examiner acknowledges that Samson “does not use the term
„hyperelastic‟ or discuss the flexural modulus or [yield] strain” of the
various layers in its catheter shaft (Ans. 5). However, the Examiner finds
that both Samson and the present Specification disclose “similar materials”
(id. at 4), and concludes that “it would have been an obvious matter of
design choice to modify Samson to obtain the invention as specified in
claims 26 and 28-33” (id.).
Claims 26 and 28
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Appellants contend that claims 26 and 28 require that “„the second
material [of the intermediate layer] has a lower flexural modulus and a
higher yield strain than at least one of the first material [of the inner layer]
and the third material [of the outer layer] . . . .‟” (App. Br. 9 (brackets and
italics original).), yet Samson “is entirely silent as to the relationship
between the flexural moduli and yield strains of its various layers, and thus
neither teaches nor suggests the claimed invention” (id.).
Appellants contend that the Examiner has offered “no rationale, other
than perhaps the improper application of hindsight in view of the present
teaching and the advantages disclosed in the instant specification” (id.), for
arranging Bell‟s “similar materials” in the specific manner required by
claims 26 and 28.
We agree with Appellants. A rejection on the ground of obviousness
must include “articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006). “[T]his analysis should be made explicit” and it “can be
important to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co., v. Teleflex Inc., 550 U.S. 398,
418 (2007). Here, the Examiner has not adequately explained why one of
ordinary skill in the art would have had reason to select materials with the
requisite properties from Samson’s disclosure and arrange them in the
specific manner required by claims 26 and 28.
Claims 29-33
With respect to claims 29-33, Appellants contend that “Samson
neither teaches nor suggests the claimed arrangement of reinforcing layers.
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Instead, Samson discloses only braided reinforcing layers” (App. Br. 10).
That is, “Samson discloses that each reinforcing layer includes wires wound
in both a clockwise direction and a counter-clockwise direction” (id.), and is
“therefore at odds with the claimed invention, which recites one reinforcing
layer wound in only one direction and a second reinforcing layer wound
only in the opposite direction” (id.).
The Examiner acknowledges that “additional structure is present” in
Sampson” (Ans. 9), but finds that “[t]he claim[] language is open via the use
of „comprising‟ and there is nothing in the claim language that states that a
second wire wound opposite the first in each reinforcing layer cannot be
present” (id.).
During examination, the USPTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that
may be afforded by the written description contained in the applicant‟s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Nevertheless, “it does not follow that limitations from the specification may
be read into the claims.” Sjolund v. Musland, 847 F.2d 1573, 1581 (Fed.
Cir. 1988).
This is a difficult balancing act. However, despite Appellants‟
argument, claim 29 does not actually “recite[] one reinforcing layer wound
in only one direction and a second reinforcing layer wound only in the
opposite direction” (App. Br. 10 (emphasis added)). Having considered the
plain language of the claims in light of the Specification, we find that the
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Examiner‟s interpretation of the claim as encompassing two braided
reinforcing layers of the sort disclosed by Samson is not unreasonably broad.
Claims 30 and 31, however, stand on a different footing. While these
claims depend from claim 29, they additionally require an intermediate layer
that is hyperelastic relative to one or both of the inner and outer layers. As
discussed above, the Examiner acknowledges that Samson “does not use the
term „hyperelastic‟ or discuss the flexural modulus or [yield] strain” of the
various layers in its catheter shaft (Ans. 5). Again, as with claims 26 and 28,
the Examiner has not adequately explained why one of ordinary skill in the
art would have had reason to select materials with the requisite properties
from Samson’s disclosure and arrange them in the specific manner required
by claims 30 and 31.
In summary, the rejection of claims 26 and 28-33 as unpatentable over
Samson is reversed with respect to claims 26, 28, 30, and 31, and affirmed
with respect to claims 29, 32, and 33.
OBVIOUSNESS - SAMSON & DAVILA
Claims 26 and 28-33 also stand rejected as unpatentable over Samson
and Davila.
The Examiner relies on Samson as above, and cites Davila as
“evidence that the polymer material arrangement of the layers was known to
one of ordinary skill in the art” (Ans. 9).
Specifically, the Examiner finds that Davila discloses “a tri-layer
device that includes wire braids with the middle layer of a more flexible
material than the inner and outer layer” (id. at 5), and that the material of the
middle layer has “a lower durometer rating” as well (id. at 6). The Examiner
also finds that Davila teaches that “the inner and outer layers are made of
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PEBAX . . . or polyamides . . . and the inner layer is made of a lower-
durometer polyurethane” (id. at 9).
The Examiner concludes that it would have been obvious for one of
ordinary skill in the art “to modify the device of Samson by making the
middle/intermediate layer of a material that is more flexible/hyperelastic
relative to the inner and outer layers as taught by Samson” (id. at 5).
Claims 26 and 28
Appellants reiterate their arguments with respect to Samson, and
further contend that “Davila likewise fails to teach or suggest the claimed
relationship between the flexural moduli of the various layers, discussing
only the relationship between material durometers and flexibilities” (App.
Br. 11), and “is silent as to the relationship between the yield strains of the
various layers.
Appellants‟ argument is persuasive. While Davila does teach that the
middle layer of its device should be more flexible than the inner and outer
layers, Appellants correctly note that Davila does not discuss yield strain at
all. While we note that the Examiner has offered unattributed definitions of
flexural modulus and yield strain (Ans. 7), the Examiner has not established
that yield strain is directly (or inversely) correlated with the flexural
modulus or durometer rating of a material. Nor has the Examiner
established that any of the specific materials discussed by Davila (e.g., the
different Pebax® formulations and polyamides that can be found in any of
the three layers) would nonetheless be arranged in a manner that satisfies the
specific requirements of claims 26 and 28.
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Thus, we find that the Examiner‟s initial burden has not been met with
respect to establishing a prima facie case of obviousness for claims 26 and
28, even in light of Davila.
Claims 29-33
Appellants contend that Davila, like Samson, “also teaches only
braided reinforcing layers” (App. Br. 11), and “[t]herefore, the asserted
combination of Samson and Davila does not yield the claimed invention or
render the claimed invention obvious” (id.).
However, as discussed above, having considered the plain language of
the claims in light of the Specification, we find that the Examiner‟s
interpretation of the claim as encompassing two braided reinforcing layers of
the sort disclosed by Samson is not unreasonably broad.
Accordingly, we will affirm the rejection of claims 29, 32, and 33 as
unpatentable over Samson and Davila.
Again, claims 30 and 31 stand on a different footing, as they
additionally require an intermediate layer that is hyperelastic relative to one
or both of the inner and outer layers. As discussed above, the Examiner
acknowledges that Samson “does not use the term „hyperelastic‟ or discuss
the flexural modulus or [yield] strain” of the various layers in its catheter
shaft (Ans. 5). While Davila expressly states that the middle layer of its
device is more flexible than the inner and outer layers, the Examiner has not
identified anything in Davila which discusses the elasticity or hyperelasticity
of the layers, or otherwise established the relative elasticity of any of the
materials disclosed as suitable for the three layers.
As with claims 26 and 28, the Examiner has not adequately explained
why one of ordinary skill in the art would have had reason to select materials
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with the requisite properties from Samson’s or Davila’s disclosures and
arrange them in the specific manner required by claims 30 and 31.
Accordingly, the rejection of claims 26 and 28-33 as unpatentable
over Samson and Davila is reversed with respect to claims 26, 28, 30, and
31, and affirmed with respect to claims 29, 32, and 33.
DOUBLE PATENTING
The Examiner has maintained the rejection of claims 26 and 29 on the
ground of nonstatutory obviousness-type double patenting over claims 1 and
16 of Application No. 11/618,570, now US Patent 8,182,466.
Appellants have not addressed this rejection. Accordingly, it is
summarily affirmed.
CONCLUSION
The rejection of claims 26 and 28-33 under 35 U.S.C. § 103(a) as
unpatentable over Samson is reversed with respect to claims 26, 28, 30, and
31, and affirmed with respect to claims 29, 32, and 33.
The rejection of claims 26 and 28-33 under 35 U.S.C. § 103(a) as
unpatentable over Samson in view of Davila is reversed with respect to
claims 26, 28, 30, and 31, and affirmed with respect to claims 29, 32, and
33.
The rejection of claims 26 and 29 on the ground of nonstatutory
obviousness-type double patenting is affirmed.
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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