Ex Parte Guo et al

Patent Trial and Appeal Board

Aug 14, 2017

12981292 (P.T.A.B. Aug. 14, 2017)

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.
12/981,292 12/29/2010 Xiaoping Guo 0B-142900US 6288
55962 7590
Wiley Rein LLP
Patent Administration
1776 K Street, NW
Washington, DC 20006
08/16/2017 EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/16/2017 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):
ptodocket @ wileyrein. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte XIAOPING GUO, JAMES V. KAUPHUSMAN,
DAVID P. JOHNSON, and KAREN L. ARMSTRONG
Appeal 2016-0022531
Application 12/981,292
Technology Center 3700
Before LINDA E. HORNER, JILL D. HILL, and NATHAN A. ENGELS,
Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Xiaoping Guo et al. (Appellants) seek our review under 35 U.S.C.
§ 134(a) of the Examiner’s decision rejecting claims 1-14, 16, and 21-24.
Final Office Action (January 8, 2015) (hereinafter “Final Act.”).2 We have
jurisdiction under 35 U.S.C. § 6(b).
1 Appellant names St. Jude Medical, Atrial Fibrillation Division, Inc. as the
real party in interest. Appeal Brief 2 (June 1, 2015) (hereinafter “Appeal
Br.”).
2 Claim 15 is pending, but not rejected, in the application on appeal. As
noted by Appellants (Appeal Br. 4 n.l), although the front page of the Final
Office Action includes claim 15 in the listing of rejected claims, the
Appeal 2016-002253
Application 12/981,292
We AFFIRM.
CLAIMED SUBJECT MATTER
Appellants’ claimed subject matter relates to “catheters comprising
one or more hydrophobic barrier layers.” Spec. 11. Claims 1, 13, and 24
are the independent claims. Claim 1 is illustrative of the subject matter on
appeal and is reproduced below.
1. A catheter comprising an elongated structure,
wherein the elongated structure has a distal portion and a
proximal portion, wherein:
the proximal portion comprises a handle operably
connected to the proximal end of the elongated structure;
the distal portion comprises a shaft, wherein the shaft
comprises a first polymer layer bonded to a second hydrophobic
polymer layer, wherein the second hydrophobic polymer layer
comprises an ethylene-perfluoroethylenepropylene (“EFEP”)
copolymer; and
wherein the catheter is configured to be inserted into a
patient’s body.
Appeal Br. 14 (Claims Appendix).
REJECTIONS
The Final Office Action includes the following rejections:
1. Claims 1-6, 9-14, 16, 21, 22, and 24 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Holloway et al.
(US 2009/0163851 Al, published June 25, 2009) (“Holloway”)
and Blasko et al. (US 2002/0134451 Al, published September 26,
2002) (“Blasko”).
Examiner does not provide a detailed rejection of claim 15.
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Application 12/981,292
2. Claims 7 and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Holloway, Blasko, and Chen et al.
(US 7,758,892 Bl, issued July 20, 2010) (“Chen”).
3. Claim 23 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Holloway, Blasko, and Hofmann et al. (US 5,704,908, issued
January 6, 1998) (“Hofmann”).
ANALYSIS
First Ground of Rejection: Claims 1-6, 9-14, 16, 21, 22, and 24 as
unpatentable over Holloway and Blasko
Appellants argue the claims subject to the first ground of rejection as a
group. Appeal Br. 8. We select claim 1 as representative of the group, and
claims 2-6, 9-14, 16, 21, 22, and 24 stand or fall with claim 1. See 37
C.F.R. § 41.37(c)(l)(iv).
The Examiner finds that Holloway discloses the catheter of claim 1
including a distal portion of the catheter shaft comprised of a first polymer
layer and a second polymer layer wherein one of the layers comprises an
EFEP copolymer. Final Act. 2. The Examiner states that Holloway “does
not disclose if the two layers are bonded together.” Id. at 3. The Examiner
finds that “Blasko discloses a tube which is capable of being used as a
catheter” comprising an elongated structure having a shaft made of a first
polymer layer bonded to a second hydrophobic EFEP copolymer layer. Id.
The Examiner further finds that Blasko teaches EFEP makes the tube more
chemically resistant but less strong and flexible. Id. (citing Blasko Tflf 27,
28). The Examiner determines it would have been obvious to have modified
Holloway to bond the two polymer layers together, as taught by Blasko, “to
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Application 12/981,292
make the catheter of Holloway a stronger, more chemically-resistant catheter
than it would be with only one layer.” Id. at 3—4.
Appellants argue the Examiner erred in finding that Blasko discloses
its tubing is capable of use with pharmaceutical compositions. Appeal Br. 9
(arguing that “[pjroperly interpreted, Blasko only teaches the use of its
tubing in the manufacture of pharmaceuticals.”). Appellants further
contend that Blasko discloses tubing used only in industrial applications and
that Blasko is not analogous art to the claimed catheter. Appeal Br. 10.3 4
Contrary to Appellants’ characterization of Blasko’s teachings as
being limited to industrial applications, Blasko discloses certain illustrative
industrial uses for its tubing, but Blasko further teaches that its tubing can be
used in other applications requiring chemical or environmental resistance.
In particular, Blasko discloses that for “illustrative purposes,” the two or
more layer tubular polymer composite is described in connection with its use
with applications “such as for fuel transfer, oil or other natural resource
recovery, chemical or pharmaceutical processing, or other applications
requiring chemical or environmental resistance.” Blasko 121. Blasko
further teaches, “It will be appreciated, however, that aspects of the present
invention may find use in other hose and tubing constructions in other fluid
transfer applications, and in a variety of hydraulic or pneumatic power or
control applications.” Id.
3 Appellants also argue that the Blasko is not analogous to Holloway.
Appeal Br. 9-10. This is not the appropriate inquiry for analogous art,
which examines whether the prior art is analogous to the claimed invention.
We address the Examiner’s reason to modify Holloway with Blasko infra.
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Appellants argue that “Blasko is concerned with chemical and/or
environmental breakdown of an industrial hose.” Appeal Br. 10 (citing
Blasko 19). We note, however, that Blasko defines “chemical resistance” as
meaning “the ability to resist swelling, crazing, stress cracking, corrosion, or
otherwise to withstand attack from mild acidic or alkaline solutions,
phosphate-ester solutions, and alcohols and other organic solvents and
hydrocarbons, as well as inorganic solvents such as water or brine.” Id. at
127 (emphasis added). Thus, Blasko broadly addresses and is applicable to
degradation of tubing in aqueous environments.
As such, we disagree with Appellants that one having ordinary skill in
the art would understand Blasko’s teachings to be limited to tubing used in
industrial applications. Despite Blasko’s failure to specifically describe its
tubing for use in catheter applications, for the reasons that follow, Blasko’s
disclosure is relevant to the problem facing Appellants, and is thus
analogous art to the claimed invention. See In re Clay, 966 F.2d 656, 658—
69 (Fed. Cir. 1992) (one criterion for determining whether prior art is
analogous is “whether the reference ... is reasonably pertinent to the
particular problem with which the inventor is involved”).
Specifically, with respect to the problem facing Appellants, the
Specification describes that “[djuring a [catheterization] procedure, a
catheter may be exposed to an aqueous environment comprising blood
and/or other bodily fluids” and “[t]he mechanical and material properties of
a catheter should remain constant during such a procedure and not be
affected by the environment contacting the catheter.” Spec. 13. The
Specification describes:
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Application 12/981,292
During clinical procedures, catheter shafts may be
exposed to aqueous surroundings of the vessel and human
anatomy for prolonged time, and any exposed polar polymeric
materials of a catheter shaft may, as a consequence, unavoidably
absorb water, which may act as a plasticizer for exposed polar
polymeric shafts. . . . The moisture absorbed into the materials
may act as a plasticizer, potentially leading to decreases in the
catheter shaft’s mechanical strength and stiffiiess/rigidity. As a
result, such shafts could exhibit mechanical softening
phenomena over time, which could lead to decreases in
mechanical strength, column stiffness, pushability, torqueability,
and the like. As a consequence, this softening could lead to
changes in end-use performance, such as compromised catheter
shaft deliverability along a vessel and poor shaft maneuverability
within the target human anatomy. Moreover, any such in­
procedure performance changes could affect an operating
physician’s perception of use.
Spec. 139. Based on these descriptions, the problem facing Appellants at
the time of the invention was to devise tubing for a catheter that could resist
mechanical and material property changes when exposed to aqueous
environments within the body. Blasko’s teaching of two-layer composite
tubing useful for applications that require resistance from aqueous
environments is directly pertinent to this problem. See Clay, 966 F.2d at 659
(“A reference is reasonably pertinent if, even though it may be in a different
field from that of the inventor's endeavor, it is one which, because of the
matter with which it deals, logically would have commended itself to an
inventor's attention in considering his problem.”). For these reasons,
Appellants have not demonstrated error in the Examiner’s reliance on
Blasko in the rejection of claim 1.
Appellants further argue that the Examiner resorted to “improper
hindsight” in the proposed modification of Holloway with the teaching of
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Blasko and that the modification “would alter the principle of operation of
Holloway.” Appeal Br. 10. Appellants fail to explain the basis for the
assertion that the modification to bond together Holloway’s polymer layers
in the manner disclosed in Blasko would alter the principle of operation of
Holloway. With regard to the bonding of first layer 16 and second layer 18,
Blasko teaches:
[T]he inner surface, 20, of the first layer 16 itself, and the outer
surface, 22, of the second layer 18 itself, or vice versa as the case
may be, are directly bonded together, i.e., without the use of an
intermediate tie-layer or adhesive, and also generally without
preparation, priming, or other treatment of surfaces 20 and 22 so
as to allow the member 10 to be formed by a continuous co­
extrusion or other extrusion.... With the layers 16 and 18 being
co-extruded or otherwise formed, a thermal “fusion” bond may
be formed therebetween, such as by the intermingling of melt
material from the layers.
Blasko 124. Thus, Blasko teaches that it is conventional, when forming
multi-layer tubing that is chemically and environmentally resistant, to bond
the polymer layers together. In light of the general knowledge in the art of
bonding polymer layers of a multi-layer tube, we agree with the Examiner’s
determination that bonding the polymer layers of Holloway’s two-layer
catheter tubing to each other fails to present a nonobvious distinction over
the prior art. Appellants have failed to demonstrate that the Examiner relied
on impermissible hindsight reasoning in reaching the determination of
obviousness. Accordingly, we sustain the rejection of claim 1, and claims
2-6, 9-14, 16, 21, 22, and 24, which fall with claim 1, as unpatentable over
Holloway and Blasko.
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Second Ground of Rejection: Claims 7 and 8 as unpatentable over
Holloway, Blasko, and Chen
Claim 7 recites that the first layer comprises “an amine-terminated
poly(ether block amide) (‘PEBA’).” Appeal Br. 14 (Claims App.). Claim 8
depends from claim 7. Id. Appellants argue claims 7 and 8 as a group. Id.
at 11-12. We select claim 7 as representative and claim 8 stands or falls
with claim 7. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner finds that “Chen discloses a tube in which layers are
covalently bound together based upon their charge” and that Chen further
discloses using PEBAX “in such bondings.” Final Act. 7-8 (citing Chen,
col. 3,1. 58, col. 4,11. 62-67). The Examiner determines it would have been
obvious to further modify the catheter of Holloway to use PEBAX in the
first layer based on its suitability for the intended use as a matter of obvious
design choice. Id. at 8.
Appellants argue that “PEBAX is only disclosed as one of hundreds
of types of ‘substrates containing polymers and other high molecular weight
materials’” and that “[t]o modify the (improper) combination of Holloway
and Blasko, through trial and error with all of the substrates disclosed in
Chen, would have required undue experimentation by one of ordinary skill
in the art.” Appeal Br. 11. The Examiner responds that “it requires routine
skill in the art to look at a list and determine which materials to use with a
device.” Ans. 9-10. We agree with the Examiner’s finding that Chen
discloses PEBAX is a suitable material for use to covalently bond with other
layers of a multilayer tube used for medical devices, such as catheters.
Chen, col. 3,11. 4-13, 42^14, 58-59, col. 4,11. 62-67.
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Further, we find that the Examiner set forth a prima facie case of
obviousness in light of Chen. In particular, selection of a known polymer,
based on Chen’s disclosure of PEBAX as suitable for the intended use as a
layer of a multi-layer composite tubing, is not a patentable distinction over
the prior art. See In re Leshin, 277 F.2d 197 (CCPA 1960) (selection of a
known plastic to make a container of a type made of plastics prior to the
invention was held to be obvious). Appellants’ assertion that selection of
this known polymer for use in the catheter of Holloway, as modified by
Blasko, would have required undue experimentation is unsupported by
evidence or technical reasoning adequate to overcome this prima facie
showing by the Examiner.
Appellants further argue the Examiner misread Chen, that Chen
discloses using PEBAX only as a balloon substrate over which the plurality
of layers are applied, and that PEBAX is not used as part of the plurality of
tube layers. Appeal Br. 11 (Appellants contending that construing a
substrate as a layer “distorts the plain meaning of the term ‘layers’”).
Chen discloses that “[t]he multilayer regions of the present invention
can be assembled using layer-by-layer techniques . . . used to coat a wide
variety of substrates” and that “[sjubtrates . . . include substrates that are
incorporated into the finished medical device, as well as substrates that
merely act[] as templates for the layer-by-layer technique.” Chen, col. 3,
11. 4-7, 14-18; see also id. at col. 11,11. 20-25 (disclosing an example the
use of a PEBAX balloon as a substrate that becomes incorporated into the
finished medical device). Based on the disclosure in Chen that the substrate
can be incorporated into the finished product, we agree with the Examiner
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that “one reading Chen would appreciate that its substrate is merely a base
layer upon which other layers are applied.” Ans. 10.
Appellants further contend that “Chen teaches away from Blasko”
because Chen teaches medical devices that are soluble in water. Appeal
Br. 12 (citing Chen, col. 7,11. 25-32). The Examiner responds that Chen
does not teach away because the final product of Chen is not permeable to
water and this property occurs only during manufacturing of the device.
Ans. 10.
We disagree with Appellants’ reading of Chen as teaching a medical
device that is soluble in water. Rather, Chen discloses that “the multilayer
regions of the present invention typically include the following: (a) a
plurality of charged nanoparticle layers, which contain charged
nanoparticles, and (b) a plurality of charged polyelectroyte [sic] layers,
which contain one or more charged polyelectrolyte species.” Chen, col. 6,
11. 14-18. Chen further discloses, with respect to the polyelectrolyte species,
that “a wide variety of these materials are also available for use in forming
charged polyelectrolyte layers” and that the number of charged groups in the
polyelectrolytes is usually so large that the polymers are soluble in polar
solvents including water when in ionically dissociated form. Id. at col. 7,
11. 25-32. Thus, Chen discloses a polyelectrolyte species that is usually
soluble in water when in ionically dissociated form that is used to form
polyelectrolyte layers of the multilayer medical device. Chen does not,
however, teach a medical device soluble in water and does not teach away
from using the disclosed PEBAX® material as a layer in the multilayer
medical device of Holloway. Further, as noted by the Examiner (Final
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Act. 7), Holloway discloses constructing first shaft 204 of PEBA (e.g., 25-
72 D PEBAX® material). Holloway 1118. Thus, we do not find error in
the Examiner’s proposed modification of the catheter of Holloway, as
modified by Blasko, with the teachings of Chen. Accordingly, we sustain
the rejection of claims 7 and 8 as unpatentable over Holloway, Blasko, and
Chen.
Third Ground of Rejection: Claim 23 as unpatentable over Holloway,
Blasko, and Hofmann
Appellants rely on the arguments presented in support of independent
claim 1 over Holloway and Blasko as the basis for patentability of dependent
claim 23. Appeal Br. 12 (“Hofmann . . . does not overcome the
shortcomings of the combination of Blasko and Holloway”). For the reasons
discussed supra, we find no error in the rejection of claim 1 based on
Holloway and Blasko, and, thus, we likewise sustain the rejection of
dependent claim 23 over Holloway, Blasko, and Hofmann.
DECISION
The Examiner’s decision rejecting claims 1-14, 16, and 21-24 are
affirmed.
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)(l)(iv).
AFFIRMED
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