Ex Parte Gloss et al

Patent Trial and Appeal Board

Sep 12, 2016

13411363 (P.T.A.B. Sep. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/411,363 03/02/2012 Michael GLOSS
28390 7590 09/14/2016
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
P0040856.USU1 7239
EXAMINER
ZIMBOUSKI, ARIANA
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
09/14/2016 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):
rs.vasciplegal@medtronic.com
medtronic_cv_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL GLOSS, ERIC BOONE,
NEIL NYE and HANAM PHAM
Appeal2014-008787
Application 13/411,363
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A.
POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134 from the
Examiner's rejection of claims 1-20. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
STATEMENT OF THE CASE
The Specification discloses that "[ c ]onventional cardiopulmonary
bypass uses an extracorporeal blood or perfusion circuit that is coupled
between the arterial and venous cannulae" (Spec. i-f 3). The Specification
1 Appellants identify the Real Party in Interest as Medtronic Inc. (App. Br.
3).
Appeal2014-008787
Application 13/411,363
discloses that it is "necessary to minimize the introduction of air into blood
in the extracorporeal blood circuit, and to remove any air that does
accumulate before the ... blood is returned to the patient" (id.).
[A]ir introduced through the cannula may be easily separated
from the blood when it enters the reservoir by simply allowing
the large bubbles to float to the surface of the reservoir ....
However, if the bubbles at or immediately before the reservoir
from the cannula are broken up, for example, by turbulent flow
or sharp edges, they will lose their buoyancy and have the risk
of passing through the reservoir filtration media.
(id. at i-f 4.) The Specification states that "luer ports traditionally are placed
on the reservoir downtube at a 90° angle," which creates turbulent flow (id.
at i-f 5). The Specification describes the desirability to minimize turbulent
flow in order to avoid breaking up large air bubbles into smaller forms (see
id. ,-r,-r 3---6).
Claim 1 is representative of the claims on appeal and reads as follows
(emphasis added):
1. An extracorporeal blood circuit reservoir device comprising:
a housing defining a main chamber;
an exit port fluidly connected to the main chamber;
a venous inlet sub-assembly mounted to the housing and including:
a downtube forming a primary lumen extending between and open at
opposing inlet and outlet ends, the downtube defining an inlet section
adjacent the inlet end and an outlet section adjacent the outlet end,
a first luer port connector body extending from the inlet section and
forming a passageway open to the primary lumen at a flow opening,
wherein the port connector body is arranged relative to the inlet
section such that a flow path of fluid flow from the passageway into the
primary lumen merges with a flow path of fluid flow along the primary
lumen at an angle of less than 90Q;
wherein the venous inlet sub-assembly is arranged to locate the inlet
section and the port connector body outside of the housing and the outlet
section within the housing; and
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Appeal2014-008787
Application 13/411,363
a venous filter maintained within the housing fluidly between the
outlet end and the exit port.
Independent claim 16 is similarly directed to a blood circuit that
recites an angle limitation. Specifically, claim 16 requires among other
elements "wherein the secondary flow path merges with the primary venous
flow path within the inlet section at an angle less than 90°." Independent
claim 18 is a method claim directed to treating extracorporeal blood that
requires "directing [the] secondary source blood into the downtube via a luer
port connector body at a location upstream of the outlet end, including the
secondary source blood flow merging with the venous source blood flow at
an angle of less than 90°."
The claims stand rejected under 35 U.S.C. § 103(a) as fr)llows:
I. claims 1--4, 7-9, 11-14, and 18 in view ofWendler2 and
Carson· 3
'
JI~ clairn 5 ir1 vie-vv of~''lendler~ Carson, and Chavez;4
III. claim 6 in view of \Vendler, Carson, and Erickson;5
IV. claim 10 in view of Wendler, Carson, and Lindsay; 6
V. claim 15 and 20 in view of Wendler, Carson, and Hopper; 7 and
2 Wendler et al., US 2010/0211028 Al, published Aug. 19, 2010; hereinafter
"Wendler".
3 Carson et al., US 4,818,490, issued Apr. 4, 1989; hereinafter "Carson".
4 Chavez et al., US 6,981,969 B2, issued Jan. 3, 2006; hereinafter "Chavez".
5 Erickson, US 4,781,686, issued Nov. 1, 1988.
6 Lindsay, US 5,304,164, issued Apr. 19, 1994.
7 Hopper et al., US 2010/0011557 Al, published Jan. 21, 2010; hereinafter
"Hopper".
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Appeal2014-008787
Application 13/411,363
VJ. claims 16, 17, and 19 in view of \Vendler, Carson, Carpenter, 8
and Hart. 9
The Examiner finds that Wendler discloses "an extracorporeal blood
circuit reservoir device" meeting most of the claimed structural requirements
(Ans. 2). Wendler does not disclose "the port connector body having a luer
port ... [but] discloses that luer ports are often used in these devices and
also discloses using them for other connections" (id. at 3), therefore, the
Examiner concludes that it would have been obvious to a person of ordinary
skill in the art to include a luer port in "Wendler's port connector body ...
in order to easily connect tubing or locks to the port" (id.). The Examiner
finds that Wendler does not disclose that the port connector body is
"arranged relative to the inlet section such that a flow path of fluid flow
from the passageway into the primary lumen merges with a flow path of
fluid flow along the primary lumen at an angle of less than 90°" (id. at 4).
According to the Examiner, Carson discloses this limitation (id.).
Specifically, the Examiner finds that port 42 of Carson is "connected to port
40 at an angle that is not perpendicular, allowing for a flow path of fluid
from port 42 connecting with the lumen of inlet 40 to be at an angle of less
than 90° ( ... side of port 42 is visible in horizontal view in which port 40 is
also horizontal)" (id.). The Examiner concludes that it would have been
obvious to a person of ordinary skill in the art, in view of Carson, to have
Wendler's "first luer port connector body ... situated for a fluid flow ... at
an angle of less than 90° ... in order to allow for additional blood to flow
8 Carpenter et al., US 7,189,352 B2, issued Mar. 13, 2007; hereinafter
"Carpenter".
9 Hart et al., US 5,630,946, issued May 20, 1997; hereinafter "Hart".
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Appeal2014-008787
Application 13/411,363
into the reservoir device while also discouraging fluid turbulence and fluid
damage" to blood cell components (id.). The Examiner reasons that "the
extension angle defined at an intersection of an axial centerline of the
passageway with a central axis of the primary lumen of Wendler (the angle
between the centerline of the primary lumen 116 and the centerline of the
port connector 124 ... ) would ... be less than 90°" (id.).
Appellants contend that Carson does not discuss the "angle between
the supply port 40 and the secondary port 42; from the perspective of the
side view of FIG. 1, the true angle between the ports 40, 42 cannot be
affirmatively stated" (App. Br. 9); issues that arise "when blood flow
contacts a physically stationary surface or object ... has no relationship or
bearing upon a first fluid flow merging into a second fluid flow" (id. at 9-
10); and that "[t]he Examiner's Answer fails to identify any basis or support
for these alleged 'benefits' of the purported Carson port arrangement"
(Reply Br. 5).
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of Wendler and Carson
suggests a device with a port connector feeding fluid into an inlet already
having a fluid flow in a way that the fluid streams come together at an angle
of less than 90°?
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Appeal2014-008787
Application 13/411,363
Findings of Fact
FF 1. Carson discloses a "blood oxygenating apparatus" (Carson, col.
1, 11. 11-12). Figure 1 of Carson is shown below:
.. ~-"·""""'""""""""""""""""'"""""""""""""""""""""'"""""""~\ , ..... -·:·~
~··"·· ~f:...._,..._,,,,..._..._..._..._..._ .... ,,,-.;..:~ .. ~.:..-...-...-...-... .. -...-...-...-...-..-...-..-...x..:~''"''-...-..-..-..~;~~~~X
.J ti '~ii ,li __ ._r~~ - ,,
r~ r = ~ ~ =:~
t~.
~~ ~Z: 5~:
~~ "· .. ~.~
'
~ .. }
l ;··"* !
: ............................................. ..
~I :<~~~
:.. ........................................................................................................................................ ,::
Figure 1 shows "an elevation, somewhat diagrammatic and broken away, of
[a] blood oxygenating apparatus" (Carson, col. 1, 11. 59--60). "Blood inlet 38
has port 40 for connection to a supply line of venous blood from the patient,
port 42 for blood obtained from the patient's chest during surgery, and
smaller return port 44 for connection to return line 83 of a sampling system"
(Carson, col. 2, 11. 38-42).
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Appeal2014-008787
Application 13/411,363
FF2. Figure 2 of Carson is shown below:
Figure 2 shows "a horizontal sectional view, taken at 2-2" of Figure 1
(Carson, col. 1, 11. 62---63).
Analysis
After considering the evidence and the arguments, we conclude that
the preponderance of the evidence of record does not support the Examiner's
conclusion of obviousness.
Inlet Port Angles
Appellants contend that Carson does not discuss the "angle between
the supply port 40 and the secondary port 42 ... [therefore,] the tn.1e angle
between the ports 40, 42 cannot be affirmatively stated" (App. Br. 9).
Appellants contend that there is "[n]o understanding [in Carson] of a
relationship between the internal lumen of the supply port 40 and the
internal passageway of the secondary port 42 can reasonably be inferred
from this exterior view" (id.).
Here, the Examiner is not relying on a discussion in Carson regarding
the specific dimensions of the fluid inlet ports but instead is using Carson
Figures 1 and 2 to establish that the angle of attachments of the ports to the
device is between 0-90° (Ans. 18-19). Specifically, the Examiner's
position is that, in Carson's Figure 1, "the angle between port 40 and port 42
seem[ s] to be less than 90°, though it is Fig. 2 that makes it very clear that
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Appeal2014-008787
Application 13/411,363
the angles are indeed less than 90°" (Ans. 19; see FFl). The Examiner
further explains that Carson's Figure 2 shows "a horizontal sectional view,
taken at 2-2 of Fig. 1. Port 40 is parallel to this horizontal section 2-2, as is
shown in Fig. 1. If port 42 was actually perpendicular to port 40, then the
side of the port would not be illustrated in Fig. 2, and only the top port 42
would appear" (Ans. 19; see FF2). In Figure 2, however, "the side of port
42 is clearly displayed, [thus] making the ports not perpendicular with
respect to each other and showing that the angle between the ports is less
than 90°" (Ans. 19; see FF2).
Drawings may be relied on for prior art purposes. See MPEP 2125.
Even if the feature is unexplained in the specification, drawings must be
evaluated for what they reasonably disclose and suggest to one of ordinary
skill in the art. See In re Aslanian, 590 F.2d 914 (CCPA 1979). On the
present record, we find no error with the Examiner's reliance on Carson's
figures to establish that the two incoming blood supply lines feeding into the
oxygenator of Carson allow "for a flow path of fluid from port 42
connecting with the lumen of inlet 40 to be at an angle of less than 90°"
(Ans. 4).
Fluid Turbulence
Appellants contend that the Examiner's reliance on fluid turbulence
and fluid damage in making the prima facie case is inapt (App. Br. 9-10).
Even though it may be true "that hard edge angles can cause undue fluid
turbulence and fluid damage, damaging fragile blood cell components," this
knowledge does not provide sufficient support for the need to merge two
fluid streams at an angle, i.e. "a first fluid flow merging into a second fluid
flow as claimed" (id.).
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Appeal2014-008787
Application 13/411,363
In the Answer, the Examiner provides no further explanation on this
point and simply reiterates the position that a "person having ordinary skill
in the art would know that fluid flow of blood through intersecting lumens
affects fluid turbulence and [creates] fluid damage" to cells (Ans. 20).
On this record we find that Appellants have the better position.
Appellants' challenge the Examiner's finding that turbulence created when
two fluid streams meet experiences the same dynamics as turbulence created
when a fluid hits a hard surface. As Appellants point out (Reply Br. 5), the
Examiner cites no evidence to support the finding regarding turbulence.
In response, the Examiner merely states that one of ordinary skill
would recognize this fluid phenomenon without providing factual support
(Ans. 20). Although it is it is permissible to rely on "official notice" in
making rejections, such knowledge must be capable of instant and
unquestionable demonstration as being well-known. In re Ahlert, 424 F.2d
1088, 1091 (CCPA 1970), see MPEP 2144.03. This is not the case here, in
the practice field of fluid dynamics, these facts are not capable of instant and
unquestionable demonstration as being well-known. See Ahlert, 424 F.2d at
1091 ("Assertions of technical facts in areas of esoteric technology must
always be supported by citation to some reference work recognized as
standard in the pertinent art and the appellant given, in the Patent Office, the
opportunity to challenge the correctness of the assertion or the notoriety or
repute of the cited reference.").
We conclude that the preponderance of the evidence of record does
not support the Examiner's conclusion that the combination of \Vend!er and
Carson suggests a device with all limitations of independent claims 1, 16,
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Appeal2014-008787
Application 13/411,363
and 18 and dependents thereof We thus reverse each of the rejections under
35 U.S.C. § 103(a) that rely on the teachings of Wendler and Carson.
SUMMARY
We reverse the rejection of all claims.
REVERSED
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