Ex Parte Wang et al

Patent Trial and Appeal Board

Mar 30, 2017

12539110 (P.T.A.B. Mar. 30, 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.
12/539,110 08/11/2009 Dongfang Wang 1936-002 8660
1009 7590 04/03/2017
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE, SUITE 200
LEXINGTON, KY 40503
EXAMINER
BOSQUES, EDELMIRA
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
04/03/2017 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):
u spto @ iplaw 1. net
laura @ iplaw 1. net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DONGFANG WANG and JOSEPH B. ZWISCHENBERGER
Appeal 2015-006574
Application 12/539,1101
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 12—14, 16, and
32—34 (Br. 25). Examiner entered rejections under 35 U.S.C. § 102(b) and
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART. However, because our rationale differs from
Examiner’s we designate the affirmance a new ground of rejection. We also
enter a New Ground of Rejection over Appellants’ claim 12.
1 Appellants identify “the real parties in interest [as] W-Z Biotech, LLC”
(see Br. 3).
Appeal 2015-006574
Application 12/539,110
STATEMENT OF THE CASE
Appellants’ “invention relates to cardiac medical devices and systems
for use in artificial lung (AL) and right ventricular assist device (RVAD)
applications” (Spec. 11). Claims 12, 14, and 32 are representative and
reproduced below:
12. A dual lumen cannula for delivering a fluid into and
removing a fluid from an interior of a heart of a human body,
comprising:
a first, drainage lumen having a first length and including
at least one distal drainage aperture for removing a fluid from the
interior of a human heart right atrium;
and
a second, delivery lumen for delivering a fluid, the second
lumen having a length that is greater than the first lumen length
and a selectively flexible portion for translating a distal end of
the second lumen from a first configuration to a second
configuration defining a predetermined angle or curvature for
delivering the fluid to an interior of a human pulmonary artery
lumen or an interior of a human heart left atrium;
said second lumen length and predetermined angle or
curvature being dimensioned to position a distal end of the
second lumen in an interior of the pulmonary artery lumen or the
heart left atrium interior when a distal end of the first lumen is
disposed within the heart right atrium.
14. The dual lumen cannula of claim 12, wherein the second
lumen includes a distal extendable infusion sleeve disposed in an
interior thereof for extending and delivering a fluid therethrough.
32. A dual lumen cannula for delivering a fluid into and
removing a fluid from an interior of a heart of a human body,
comprising:
a first, drainage lumen having a first length and including
at least one distal drainage aperture for removing a fluid from the
interior of a human heart right atrium;
2
Appeal 2015-006574
Application 12/539,110
a second, delivery lumen for delivering a fluid, the second
lumen having a length that is greater than the first lumen and
including a distal extendable infusion sleeve disposed in an
interior of said second lumen for extending and delivering a fluid
therethrough, the second lumen further including a selectively
flexible portion for translating the second lumen from a first
configuration to a second configuration defining a predetermined
angle or curvature for delivering the fluid to an interior of a
pulmonary artery lumen or an interior of a human heart left
atrium;
said second lumen length and predetermined angle or
curvature being dimensioned to position a distal end of the
second lumen in an interior of the pulmonary artery lumen or the
heart left atrium interior when a distal end of the first lumen is
disposed within the heart right atrium.
The claims stand rejected as follows:
Claims 12, 13, and 16 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Appling.2
Claims 14 and 32—34 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Appling and Maginot.3
Anticipation'.
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appling teaches Appellants’ claimed invention?
2 Appling et al., US 2008/0108975 Al, published May 8, 2008.
3 Maginot et al., US 6,475,207 Bl, issued Nov. 5, 2002.
3
Appeal 2015-006574
Application 12/539,110
ANALYSIS
Appellants’ independent claim 12 requires, inter alia, that the
structure of the second lumen, specifically the second lumen’s length and
predetermined angle or curvature, is dimensioned to position a distal end of
the second lumen in an interior of the pulmonary artery lumen or the heart
left atrium interior when a distal end of the first lumen is disposed within the
heart right atrium (see Appellants’ claim 12 (emphasis added)). Examiner
correctly finds that
[a] recitation of the intended use of the claimed invention must
result in a structural difference between the claimed invention
and the prior art in order to patentably distinguish the claimed
invention from the prior art. If the prior art structure is capable
of performing the intended use, then it meets the claim.
(Ans. 3.) Examiner, however, failed to establish that Appling teaches a
device that is capable of achieving the functional requirements of
Appellants’ claimed invention. To the contrary, Examiner finds that the
second lumen of Appling’s device has a “length and predetermined angle or
curvature [] dimensioned to position a distal end of the second lumen in or
near the interior of the pulmonary artery lumen or the second heart chamber
interior when a distal end of the first lumen is disposed within the first heart
chamber’’ (id. at 2—3). In addition, Examiner asserts that the functional
requirements of Appellants’ claimed invention may be obtained only when
Appling’s device is used in certain patients, finding
that a distance from a pulmonary artery lumen and a first heart
chamber may vary depending on the size of the human body to
be treated. For example the dimensions for a neonatal or
premature infant heart would be significantly smaller than the
hearts dimensions of a normal adult or an adult with a
4
Appeal 2015-006574
Application 12/539,110
cardiomegaly. For the aforementioned reasons, the examiner
sustains that the device of Appling is capable of being used for
the intended purpose.
(See Ans. 7—8.)
Appellants’ claim 12 does not recite “a distal end of the second lumen
near an interior of the pulmonary artery lumen or the heart left atrium
interior when a distal end of the first lumen is disposed near the heart right
atrium,” nor is it limited to a particular patient population. Instead, claim 12
recites “said second lumen length and predetermined angle or curvature
being dimensioned to position a distal end of the second lumen in an interior
of the pulmonary artery lumen or the heart left atrium interior when a distal
end of the first lumen is disposed within the heart right atrium” (Appellants’
claim 12 (emphases added)). In addition, claim 12 recites “a heart of a
human body” and as opposed to the heart of a particular human body, such
as a neonatal or premature infant. When reading the claims in light of
Appellants’ Specification, we find that Examiner’s interpretation of “[a] dual
lumen cannula for delivering a fluid into and removing a fluid from an
interior of a heart of a human body” to include a device sized for an infant
when compared to an adult with cardiomegaly, is unreasonable, and agree
with Appellants that “[n]o inkling of fact and/or technical reasoning was
provided to support this position. Instead, the Office has based its entire
argument on speculation and assumption” (Br. 18; FF 1—2).
Accordingly, on this record, Examiner failed to establish an
evidentiary basis to support a finding that Appling teaches a device that is
capable of performing the function required by Appellants’ claimed
invention.
5
Appeal 2015-006574
Application 12/539,110
Therefore, we reverse the anticipation rejection of claim 12. Because
they depend from claim 12, we also reverse the anticipation rejection of
claims 13 and 16.
Obviousness:
NEW GROUND OF REJECTION
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Maginot discloses a catheter system that
includes a multi-lumen working catheter having a first distal
working orifice and a second distal working orifice. The catheter
system further includes a guide catheter having a guide lumen
and a distal guide orifice. . . . When the working catheter is
locked in the operative position, (i) the working catheter extends
through the guide lumen of the guide catheter and out of the distal
guide orifice of the guide catheter, and (ii) the first distal working
orifice and the second distal working orifice are each positioned
outside of the guide catheter.
(Maginot Abstract; see also Ans. 4 and 6.)
6
Appeal 2015-006574
Application 12/539,110
FF 2. Maginot’s Figure 16 is reproduced below:
Maginot’s FIG 16 illustrates
a distal portion of the guide lumens 308, 310 of the catheter
system 300 may be alternatively configured so that the distal
portion of the guide catheter 302 is arranged in a bifurcated
configuration. ... In such a configuration, the distal portion of
the guide lumen 310 is arranged so as to gradually extend away
from the distal portion of the guide lumen 308 ... the guide
catheter 302 can be said to possess a “split-tip” configuration.
(Maginot 18:48—57; see also Ans. 4 and 6.)
FF 3. Maginot suggests that
[t]he first working catheter 303 includes a lumen 334. The lumen
334 defines a distal orifice 336. Similarly, the second working
catheter 304 includes a lumen 338. The lumen 338 defines a
distal orifice 340. The distal orifice 336 is defined in a distal
segment 342 of the first working catheter 303. Similarly, the
distal orifice 340 is defined in a distal segment 344 of the second
working catheter 304.
(Maginot 17:1—7; see also Ans. 4 and 6.)
7
Appeal 2015-006574
Application 12/539,110
FF 4. Appling discloses “[a] vascular access catheter that has a substantially
distal end portion that has a distal tip. The distal end portion has a sloped
face in the distal portion of the catheter, an outflow lumen aperture, and a
second inflow lumen aperture” (Appling Abstract; see also Ans. 2).
FF 5. Appling’s Figure 3 A is reproduced below:
16
t / / • fci' ^
....................'' ' \j .
V: A •. . .nj-
i/ A "aa i ^ '
FIG, 3A
s38
Figure 3 A illustrates that “an enlarged partial cross-sectional view of [a]
catheter with a curved distal portion, in accordance with” Appling’s
disclosure (Appling 137).
FF 6. Appling discloses that
The catheter shaft [] is preferably more flexible at its distal
portion [] than its proximal portion [] because the distal portion
[] is of a reduced diameter and is formed with less material,
compared to the proximal portion []. The catheter shaft [] may
optionally be comprised of material of different durometers to
produce a shaft [] with enhanced flexibility at the distal portion .
. . to prove a catheter [] with an atraumatic tip, when placed
within a vessel.
(Appling | 52; see id. 1 80 (“The distal portion of the catheter has flexibility
and a shaped memory, formed during the manufacturing process of the
catheter, which allows the substantially curved distal portion of the catheter
[] to return to its original curved unstressed state after the guidewire [] has
been removed”); see also Ans. 3.)
8
Appeal 2015-006574
Application 12/539,110
ANALYSIS
Claim 12:
Maginot discloses a multi-lumen catheter comprising first and second
distal working orifices or lumens, wherein the length of the second lumen is
greater than the first lumen (see FF 1—3). Maginot also suggests that
a distal portion of the guide lumens 308, 310 of the catheter
system 300 may be alternatively configured so that the distal
portion of the guide catheter 302 is arranged in a bifurcated
configuration. ... In such a configuration, the distal portion of
the guide lumen 310 is arranged so as to gradually extend away
from the distal portion of the guide lumen 308 ... the guide
catheter 302 can be said to possess a “split-tip ” configuration.
(FF 2 (emphases added).) Thus, a person of ordinary skill in this art would
have recognized that the second lumen of Maginot’s bifurcated device is
capable of being positioned in an interior of the pulmonary artery lumen or
the heart left atrium interior when a distal end of the first lumen is disposed
with the heart right atrium. In addition, a person of ordinary skill in this art
would have recognized that the first lumen of Maginot’s device is capable of
removing a fluid from the interior of a human heart right atrium and the
second lumen is capable of delivering fluid to an interior of a human
pulmonary artery lumen or an interior of a human heart left atrium (see FF
1—3; cf. Appellants’ claim 12).
Maginot does not expressly disclose a lumen comprising a selectively
flexible portion for translating a distal end of the second lumen from a first
configuration (cf. Appellants’ claim 12). Appling, however, discloses a dual
lumen catheter comprising a catheter shaft that is preferably more flexible at
its distal portion than its proximal portion such that the distal portion has
9
Appeal 2015-006574
Application 12/539,110
enhanced flexibility to provide a catheter with an atraumatic tip when placed
within a vessel and that the distal end of the catheter may be configured to
adopt a predetermined curvature (FF 6).
Based on the combination of Maginot and Appling, a person of
ordinary skill in this art, at the time Appellants’ invention was made, would
have found it prima facie obvious to modify Maginot’s catheter system to
include the flexibility advantageously disclosed by Appling, which may
include a selectively flexible portion for translating the distal end of a
second lumen along a predetermined curvature, to provide the catheter with
an atraumatic tip when placed in a vessel (FF 1—6).
For the foregoing reasons, claim 12 is rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Maginot and Appling.4
Claim 14\
As discussed above, claim 12 is prima facie obvious in view of the
combination of Maginot and Appling. Appellants’ claim 14 depends from
and further limits the dual lumen cannula of claim 12 to require that the
second lumen includes a distal extendable infusion sleeve disposed in an
interior thereof for extending and delivering a fluid therethrough (see
Appellants’ claim 14). Claims 32—34 are not separately argued and,
therefore, stand or fall with claim 14.
4 Entry of a new grounds by the Board is discretionary under 37 C.F.R.
§ 41.50(b). Therefore, we do not weigh the patentability of claims 13 and 16
with respect to this rejection and leave them to Examiner to address in the
event of further prosecution.
10
Appeal 2015-006574
Application 12/539,110
Maginot discloses a catheter system wherein a “working catheter
extends through the guide lumen of [a] guide catheter and out of the distal
guide orifice of the guide catheter” such that, inter alia, “the second distal
working orifice [is] positioned outside of the guide catheter” (FF 1). Thus,
the combination of Maginot and Appling makes obvious a dual lumen
cannula, as set forth in Appellants’ claim 12, wherein the dual lumen
cannula further includes a distal extendable infusion sleeve disposed in the
interior of a second lumen for extending and delivering a fluid therethrough
as required by Appellants’ claim 14.
Appellants fail to establish that Maginot’s bifurcated catheter system
is incapable of performing the functional requirements of Appellants’
claimed invention. Therefore, we are not persuaded by Appellants’
contentions that the dimensions of Appling’s catheter system is not capable
of performing the functional requirements of Appellants’ claimed invention
or that “[reconfiguring Appling’s device to meet [Appellants’] claim
limitations would . . . render[] the Appling device unsuitable for its intended
purpose,” which fails to account for Maginot’s contribution to the
combination of Maginot and Appling (see Br. 19-21).
We are not persuaded by Appellants’ contention that modifying
Appling with Maginot would “mak[e] it more likely rather than less likely
that the distal end of the outflow lumen would contact a blood vessel wall
interior and occlude fluid flow or increase contact with and damage to the
vessel wall” (Br. 21; see also id. at 22). Notwithstanding Appellants’
contention, and absent evidence to the contrary, modifying Maginot’s
catheter system to include Appling’s flexible distal end, which comprises a
11
Appeal 2015-006574
Application 12/539,110
predetermined curvature, would have been prima facie obvious to a person
of ordinary skill in this art in order to provide the distal end of Maginot’s
catheter “with an atraumatic tip, when placed within a vessel,” as is
disclosed by Appling (see FF 6).
For the foregoing reasons, we affirm the rejection of claim 14 under
35 U.S.C. § 103(a) as unpatentable over the combination of Maginot and
Appling. Claims 32—34 fall with claim 14. We recognize that our rationale
differs from Examiner’s and, therefore, designate this affirmance a new
ground of rejection.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 14 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Maginot and Appling is affirmed. Claims 32—34 are
not separately argued and fall with claim 14. Because our rationale differs
from Examiner’s we designate the affirmance a new ground of rejection.
Claim 12 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Maginot and Appling.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
12
Appeal 2015-006574
Application 12/539,110
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the proceeding will be remanded
to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
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; 37 C.F.R, $ 41.50(b)
13