Ex Parte Feith et al

Board of Patent Appeals and Interferences

Mar 28, 2012

10816183 (B.P.A.I. Mar. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAYMOND P. FEITH, TIM TRUITT,
and GARY S. WERSCHMIDT
__________

Appeal 2010-009120
Application 10/816,183
Technology Center 3700
__________

Before ERIC GRIMES, LORA M. GREEN, and ERICA A. FRANKLIN,
Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
injection port adapted for use with an intravenous line. The Patent Examiner
rejected the claims as failing to comply with the written description
requirement, anticipated, obvious, and on the ground of non-statutory
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm the double patenting rejection.

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STATEMENT OF THE CASE
Claims 1-3 are on appeal. Claim 1 is representative and reads as
follows:
1. An injection port adapted for use with an intravenous line,
comprising:
a housing defining a flow channel and having an injection lumen
extending in fluid communication with the flow channel;
first portions of the housing defining a first valve seat around the
injection lumen;
second portions of the housing defining a second valve seat around
the injection lumen;
a valve element disposed to extend transverse to the injection lumen;
the valve element forming a first seal with the first valve seat in
response to a first pressure, the first pressure resulting from fluid in the flow
channel;
the valve element forming a second seal with the second valve seat in
response to a second pressure, the second pressure resulting from fluid in the
flow channel, the second pressure greater than the first pressure of the fluid
in the flow channel, and
the valve element forming an open configuration between said lumen
and said flow channel in response to a third pressure resulting from fluid in
the injection lumen in said lumen the third pressure greater than one of said
first pressure and said second pressure.

The Examiner rejected the claims as follows:
• claim 1 under 35 U.S.C. § 112, first paragraph, as failing to comply
with the written description requirement;
• claim 1 under 35 U.S.C. §102(b) as anticipated by Richmond;1
• claims 1-3 under 35 U.S.C. § 103(a) as unpatentable over
Blomquist2 and Brost;3 and

1 US Patent No. 4,946,448 issued to Douglas S. Richmond, Aug. 7, 1990.
2 US Patent No. 4,922,954 issued to James E. Blomquist et al., May 8, 1990.
3 US Patent No. 3,889,710 issued to Julien H. Brost, Jun. 17, 1975.
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• claims 1-3 on the ground of non-statutory obviousness-type double
patenting as unpatentable over claims 1 and 5-7 of Feith.4

WRITTEN DESCRIPTION
The Issue
The Examiner’s position is that the Specification does not disclose
“the first pressure resulting from fluid in the flow channel” or “a third
pressure resulting from fluid in the injection lumen greater than one of said
first pressure and said second pressure.” (Ans. 3.)
Appellants contend that the amendments adding these recitations “did
not change the operation of the port of claim 1, but rather merely clarified
the existing limitations of claim 1.” (App. Br. 4.) Further, Appellants
contend that these limitations are supported by the Specification. (Id.; Reply
Br. 4-5.) In particular, Appellants assert that page 12 of the Specification
“describe[s] the operation of the two seat valve of claim 1 and Figure 12
shows the position of the valve element 70 under normal fluid flow in the
channel resting against first valve seat 96… [and] that in its normal
configuration[,] valve element 70 forms a seal with the first valve seat 96.”
(App. Br. 4-5.) Regarding the third pressure, Appellants assert that page 13
of the Specification “describe[s] the operation of the port in this state, which
is also shown by Figures 15 and 19… [i.e.,] that under the fluid pressure of
an injectate the valve element is bent downwardly and the injectate flows

4 Patent No. US 6, 364,861 B1 issued to Raymond P. Feith et al., Apr. 2,
2002.

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through the first valve and into the flow channel.” (Id.) Appellants assert
that “[t]his operation of the valve element can only occur if the pressure of
the injectate is greater than the existing pressure in the flow channel, i.e., the
first pressure or the second pressure.” (Id.)
The issue is whether the disclosure as originally filed reasonably
conveys to those skilled in the art that the inventors had possession of the
claimed subject matter as of the filing date.
Findings of Fact
1. Claim 1, as originally filed, recited, in part, “the valve element having
properties for forming a first seal with the first valve seat at a first
pressure….” (Spec. 19, ll. 9-10)(emphasis added).
2. Claim 1, as originally filed, recited, in part, “the valve element having
properties for forming an open configuration between said lumen and said
flow channel in response to a third pressure in said lumen greater than one
of said first pressure and said second pressure.” (Id. at 19, ll. 14-
16)(emphasis added).
3. Specification Figures 12 and 13 are reproduced below:

Figure 12 depicts a radial cross-section view of an injection port of the
claimed invention, and Figure 13 depicts a cross-section view illustrating the
port of Figure 12 in a high pressure configuration. (Id. at 8, ll. 14-18.)
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4. Specification Figures 14 and 15 are reproduced below:

Figure 14 and Figure 15 depict cross-section views similar to Figure 12
illustration operation of an injection port which also has aspiration
characteristics, with Figure 14 showing a further embodiment of the
invention with a valve in a normal state and Figure 15 illustrating that valve
in an injection state. (Id. at ll. 20-27.)
5. The Specification states,
Operation of the injection port 27 is best described with
reference to Figures 12 and 13. In these views, it will be noted
that the port 27 includes portions 96 which define a first valve
seat and portions 98 which define a second valve seat. The first
valve seat 96 forms a slight annulus above the valve element
70. In its normal configuration, the valve element 70, which has
elastomeric properties, is biased by the protrusion 83 beneath
the element 70 to form a seal with the first valve seat 96.

(Id. at 12, ll. 16-22.)
6. The Specification states,
When an injectate is introduced through one of the adjacent
ports, such as port 30 or 32, a relatively high pressure occurs in
the flow channel 49. By operation of the check valve 76, this
pressure is exerted against the underside of the valve element
70 of the port 27. In the manifold 18, the higher pressure will
cause the valve element 70 to deform as illustrated in Figure 13
until it comes into contact with the second valve seat 98 as
illustrated in Figure 13. With this second valve seat 98
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providing surface contact with the valve element 70, a high
pressure seal is formed without radical deformation or damage
to the valve element 70.

(Id. at ll. 24-31.)

7. The Specification states,
In its normal state, the port 32 is positioned with the valve
element 74 biased to form a first seal with the first valve seat
110 and a second seal with a third valve seat 103 as illustrated
in Figure 14. Under the fluid pressure of an injectate, as
illustrated by an arrow 112 in Figure 15, the valve element
74 is bent downwardly opening the first seal at the first valve
seat 110. The second seal with the valve seat 103 is
strengthened by this downward pressure against the valve
element 74. Nevertheless, the injectate 112 flows through the
first valve and into the flow channel 49.

(Id. at 13, ll. 18-25.)
Principles of Law
The test for written description sufficiency is whether the disclosure
of the application relied upon reasonably conveys to those skilled in the art
that the inventor had possession of the claimed subject matter as of the filing
date. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed Cir.
2010). “It is not necessary that the application describe the claim limitations
exactly, but only so clearly that one having ordinary skill in the pertinent art
would recognize from the disclosure that appellants invented processes
including those limitations.” In re Herschler, 591 F.2d 693, 701 (CCPA
1979).
Analysis
For the reasons stated by Appellants (App. Br. 4-5; Reply Br. 4-5) we
agree that the Specification disclosure reasonably conveys possession of,
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and therefore provides written description support for, the claimed subject
matter under review (see also FF 1-7.) Accordingly, we reverse the
rejection of claim 1 as failing to comply with the written description
requirement.

ANTICIPATION
The Issue
The Examiner’s position is that Richmond disclosed each element of
claim 1. (Ans. 3.) In particular, the Examiner found that Richmond’s valve
84 deformed into a different shape at the dash line depicted in Figure 2 and
that the valve rested on projections 82 which served as the second valve seat.
(Id. at 3, 7.) According to the Examiner, inherently, “a second pressure
resulting from fluid in the flow channel (a force to press down) is greater
than the first pressure at original state, therefore, the valve disc 84 is
deformed in different shape (dash line), and liquid flows downwardly
through the line 34.” (Id. at 3)(citing Richmond Figure 2 and col. 4, ll. 37+).
The Examiner found that “[t]he valve disc 84 in dash line of Fig. 2 form[s] a
second seal.” (Ans. 7.)
Appellants contend, among other things, that Richmond does not
disclose a valve element forming a second seal with a second valve seat.
(App. Br. 7; Reply Br. 5.) Specifically, Appellants assert that Richmond
elements 82 and 83 do not form a second valve seat. (Id.) Rather,
Appellants assert, Richmond describes element 82 as a series of prongs and
83 as the rounded tips of those prongs that support the valve disk 84 when
the valve is in its open position. (App. Br. 7.) Appellants assert that “[e]ven
assuming, arguendo, that the Projections could be construed as forming a
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valve seat, Richmond still fails to teach forming a valve seal with the alleged
valve seat.” (Reply Br. 5.) Appellants assert that, as acknowledged by the
Examiner’s rejection, the pressure described in Richmond from fluid in the
flow channel would move the valve into an open position allowing liquid to
flow. (App. Br. 7.) Appellants assert that “Projections 82 support the valve
disc 84 while fluid flows past the valve disc 84 and around Projections 82.”
(Reply Br. 5.) According to Appellants, a skilled artisan “would understand
the function of a seal to be inhibiting fluid flow at the seal” whereas
“Richmond describes permitting fluid flow at the alleged ‘seal.’” (Id.)
The issue is whether the Examiner established that Richmond
disclosed a valve element forming a second seal with the second valve seat
in response to a second pressure resulting from fluid in the flow channel.
Findings of Fact
8. Richmond Figure 2 is reproduced below:

Figure 2 depicts a semi-schematic, vertical, cross-sectional view of one
embodiment of the check valve of Richmond’s invention, shown in a
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condition where the differential between the downstream and the upstream
pressures acting on the valve disc is less than the pressure at which
downstream pressure is relieved. (Richmond col. 3, ll. 18-23.)
9. Richmond disclosed
A valve seat 78 extends downwardly and is around an opening
80 from the upper tubular adapter 70 into the interior of the
cylindrical skirt portion 74. The lower housing member 68
includes a series of projections or prongs 82 … which are
generally cylindrical and which have rounded ends, or tips, 83
extending upwardly and facing the valve seat 78. The
projections 82 are closely spaced to the valve seat 78 and are
positioned roughly in opposition thereto. … The projections
support a valve disc 84 when the check valve 12 is in its open
condition, permitting liquid to flow from the primary set 14 to
the patient. When the disc is in the open condition (showed by
dashed lines in Fig. 2), liquid flows downwardly through the
line 34, through the check valve upper housing 66, between the
edge of the valve disc 84 and the interior of the skirt 74,
through the spaces between the projections 82, out through the
lower housing, and into the downstream portion of the system.

(Id. at col. 4, ll. 42-62.)
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
Analysis
We agree with Appellants that Richmond does not disclose a valve
element forming a second seal with a second valve seat. (App. Br. 7; Reply
Br. 5.) The Examiner’s position is that Richmond’s projections 82 served as
a second valve seat and that Richmond’s Figure 2 disclosed that “[t]he valve
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disc 84 in dash line of Fig. 2 form[s] a second seal.” (Ans. 7.) However,
Richmond neither describes the projections 82 as a second valve seat nor
that its valve element 84 in dash line of Figure 2 forms a seal with
projections 82. Rather, Richmond discloses that its projections 82 are
closely spaced to valve seat 78 and support valve disc 84 when the check
valve 12 is in its open condition. (FF-9.) Richmond expressly states that
“[w]hen the disc is in the open condition (showed by dashed lines in Fig. 2),
liquid flows downwardly through the line 34….” (Id.) We agree with
Appellants that this disclosure does not teach that a seal is formed. Indeed,
as Appellants assert, a skilled artisan “would understand the function of a
seal to be inhibiting fluid flow at the seal [rather than] permitting fluid flow
….” (Reply Br. 5.)
Accordingly, we reverse the anticipation rejection.

OBVIOUSNESS
The Issue
The Examiner’s position is that Blomquist disclosed the limitations of
the claimed invention, including a flow lumen, but did not teach the flow
lumen “extending” in fluid communication with the injection lumen, as
claimed. (See Ans. 4-5.) In particular, the Examiner found that Blomquist
disclosed (a) “valve element 37 forming a first seal with the first valve seat
at 39 in response to a first pressure (Fig. 7), the first pressure resulting from
air/fluid in the flow channel at equilibrium condition,” and (b) “valve
element 37 forming a second seal (the valve element 37 in Fig. 8 deformed
in different shape with the valve element 37 in Fig. 7) with the second valve
seat at seating surface of element 38 in response to a second pressure.”
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(Ans. 4.) The Examiner relied on Brost as teaching the flow lumen
“extending,” as claimed, and concluded that it would have been obvious to
modify Blomquist in view of this teaching. (Id.)
Appellants contend, among other things, that Blomquist does not
disclose the valve element forming (a) a first seal with the first valve seat in
response to a first pressure resulting from fluid in the flow channel, and (b) a
second seal with the second valve seat in response to a second pressure.
(App. Br. 8-9.) Appellants assert that “[w]hen the pressures inside the tank
and outside the tank are equal, the valve element of Blomquist rests against
the valve seats 38 and 39.” (Id. at 8)(citing Blomquist Fig. 7). According to
Appellants, in Blomquist “[w]hen there is a pressure differential between the
inside of the tank and the outside of the tank, the valve element either moves
off of seat 39 to allow air to enter the tank, Figure 8, or off of seat 38 to
allow air to exit the tank, Figure 9.” (Id.)
The issue is whether the preponderance of the evidence supports the
Examiner’s finding that Blomquist taught the valve element forming a first
seal with the first valve seat in response to a first pressure resulting from
fluid in the flow channel, and a second seal with the second valve seat in
response to a second pressure.
Findings of Fact
10. Blomquist disclosed,
The sealing member 37 is placed into the vent body
prior to spinning the inner support member 34 into
place. When the inner support member is spun on, the
conical seating surface 38 extends beyond the circum-
ferential edge 39 of the vent body, and so distends the
sealing member 37 to the position shown in FIG. 7,
assuming that there is no pressure differential across the
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vent, e.g. equilibrium. In FIG. 8, the vent is shown in an
inward venting position in which the sealing member 37
is deflected away from second seat 39, e.g. by a partial
vacuum inside the tank. Similarly, FIG. 9 shows the
vent in an outward venting position, in which the tank
has excess pressure, causing the sealing member 37 to
deflect away from conical seating surface 38.

(Blomquist col. 5, ll. 17-30.)

11. Blomquist Figures 7, 8, and 9 are reproduced below:

Figures 7, 8, and 9 depict a detailed vertical sectional view of a fuel tank
gauge which incorporates an embodiment for a bi-directional pressure relief
vent of the invention. Figure 7 shows the vent in the equilibrium condition,
Figure 8 shows the vent in the inflow condition, and Figure 9 shows the vent
in the outflow condition. (Id. at col. 3, ll. 1-9.)
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Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including any differences between the claimed
subject matter and the prior art. Graham v. John Deere Co., 383 U.S. 1, 17-
18 (1966).
Analysis
The Examiner found that Blomquist discloses “valve element 37
forming a first seal with the first valve seat at 39 in response to a first
pressure (Fig. 7), the first pressure resulting from air/fluid in the flow
channel at equilibrium condition.” (Ans. 4.) The Examiner’s position is that
Blomquist taught that “at equilibrium state, the pressure inside of the tank =
the pressure outside of the tank, therefore, the air/liquid flowing at this
point.” (Ans. 8.) According to the Examiner, the recited “first pressure” can
also be broadly interpreted as the pressure under equilibrium at normal state
as in Specification Figure 14. (Id.) According to Appellants, when
“Blomquist forms a first seal between valve element 37 and valve seats 38
and 39 at equilibrium, … there is no flow through the valve and no pressure
differential.” (Reply Br. 6.)
While we agree with Appellants that there is no air/liquid flowing
through the valve in an equilibrium condition, as disclosed in Blomquist’s
Figure 7 (FF-10, 11) the claims only require the first pressure to result from
fluid in the flow channel and not fluid flow in the channel. Consequently,
we agree with the Examiner that Blomquist disclosed forming a first seal as
required by the claims. However, we agree with Appellants that Blomquist
did not disclose a second seal with the second valve seat in response to a
second pressure. As Blomquist disclosed in Figures 8 and 9 (FF-10,11) the
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valve is open to flow in one direction, i.e., inflow or outflow, and is
therefore not sealed.
Accordingly, we reverse the obviousness rejection.

OBVIOUSNESS-TYPE DOUBLE PATENTING
The Issue
The Examiner’s position is that although the conflicting claims are not
identical, they are not patentably distinct from each other because pending
claims 1-3 are not structurally distinguishable from the patented Feith claims
1 and 5-7. (Ans. 5.)
Appellants contend that the conflicting claims are structurally
distinguishable because the Feith claims do not require “the valve element
forming an open configuration between said lumen and said flow channel in
response to a third pressure resulting from fluid in the injection lumen the
third pressure greater than one of said first pressure and said second
pressure,” as recited in the rejected claims. (App. Br. 10.)
The issue is whether the conflicting claims are patentably distinct.
Findings of Fact
12. Feith claim 5 recites
The injection port recited in claim 1, further comprising:
third portions of the housing defining a third valve seat on
the side of the valve element opposite the first and
second valve seats; and
the valve element having properties for forming a third seal
with the third valve seat.

(Feith col. 7, ll. 64.)

13. Feith claim 6 recites
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The injection port recited in claim 5, wherein:
the valve element has properties for opening at least the first
seal under the pressure of an injectate in the injection
lumen to create a flow path around the valve element
between the injection lumen and the flow channel; and
the valve element has properties for opening the third seal
in response to a partial vacuum in the injection lumen
to aspirate a portion of the fluid in the flow channel
around the valve element and into the injection lumen.

(Id. at col. 7, l. 65- col. 8, l. 7.)

Principles of Law
An obviousness-type double patenting analysis entails two steps:
(1) construction of the claims of the patent and the claim in the application
to identify any differences, and (2) determination of whether the differences
in subject matter between the claims render the claims patentably distinct.
See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed Cir. 2001).
Analysis
After considering all the evidence and arguments, we conclude that
the record supports the Examiner’s conclusion that the conflicting claims are
not patentably distinct. As the Examiner correctly found, the limitation of
claims 1-3 at issue is not structurally distinguishable from the limitations
disclosed in Feith claims 1 and 5-7. (See Ans. 6 and FF-12, 13.)
Accordingly, we affirm the obviousness-type double patenting
rejection of claims 1-3.

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CONCLUSIONS OF LAW
The Specification reasonably conveys to those skilled in the art that
the inventor had possession of the claimed subject matter as of the filing
date.
The Examiner has not established that Richmond disclosed a valve
element forming a second seal with the second valve seat in response to a
second pressure resulting from fluid in the flow channel.
The preponderance of the evidence does not support the Examiner’s
finding that Blomquist taught or suggested the valve element forming a first
seal with the first valve seat in response to a first pressure resulting from
fluid in the flow channel.
The conflicting claims are not patentably distinct.

SUMMARY
We reverse the rejection of claim 1 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement;
we reverse the rejection of claim 1 under 35 U.S.C. §102(b) as
anticipated by Richmond;
we reverse the rejection of claims 1-3 under 35 U.S.C. § 103(a) as
unpatentable over Blomquist and Brost;
we affirm the rejection of claims 1-3 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claims 1 and 5-7 of
Feith.

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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

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