Ex Parte Carlyon

Patent Trial and Appeal Board

Mar 26, 2013

12409133 (P.T.A.B. Mar. 26, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES L. CARLYON
__________

Appeal 2011-003352
Application 12/409,133
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation and obviousness. The written description rejection
has been withdrawn by the Examiner. We have jurisdiction under 35 U.S.C.
§ 6(b).
Appeal 2011-003352
Application 12/409,133

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STATEMENT OF CASE
The following claim is representative.
1. A plunger activated capping system comprising:
a syringe body defining a fluid reservoir;
a plunger assembly including a plunger rod and a sealing member
supported on the plunger rod;
a luer cap releasably secured to a distal end of the syringe body, the
luer cap including a luer-type connector member and defining a fluid outlet;
and
a luer cap plug releasably supported on a distal end of the plunger rod at a
location distally of the sealing member, the luer cap plug being movable into
the fluid outlet of the luer cap upon advancement of the plunger assembly
from a retracted position to an advanced position to establish a substantial
seal within the fluid outlet.

Cited References

Stevens et al., US 5,735,825 Apr. 7, 1998
Liu, US 5,899,887 May 4, 1999
Lo, US 6,193,687 B1 Feb. 27, 2001

Grounds of Rejection
1

Claims 1-8, 10 and 17-18 are rejected under 35 U.S.C. § 102 (b) as
being anticipated by Stevens.
Claims 9, 11-13, 15-16 and 19-20 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Stevens in view of Liu.
Claim 14 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Stevens in view of Lui as applied to claim 13 above, and further in
view of Lo.

1
We note that the written description rejection has been withdrawn by the
Examiner. (Paper dated Nov. 29, 2010. See also, Reply Br. 2.)
Appeal 2011-003352
Application 12/409,133

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FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
3-15. The following facts are highlighted.
1. Specification Figs. 2 and 3 are reproduced below.

Figure 2 of the Specification shows luer cap plug 40, sterility cover 16
and cover portion 84.

Figure 3 of the Specification shows luer cap plug 40, neck portion 46, and
bulbous head 44.
2. Figures 5 and 5A of the Specification are reproduced below.
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Specification Figures 5 and 5A show luer cap plug 40 within a proximal end
of fluid outlet 68 of luer cap 14 engaging annular rib 80.
“When plunger 20 is retracted, finger 38 is pulled from bore 48
of luer cap plug 40 to disengage luer cap plug 40 from plunger
20. Syringe body 18 and plunger assembly 12 can now be
disposed of in a safe manner. Luer cap 14 remains fastened to
the indwelling catheter with luer cap plug 40 positioned to seal
outlet opening 68 of luer cap 14.” (Spec. 9.)

3. Figure 6 of the Specification is reproduced below.

Figure 6 shows when plunger 20 is retracted, finger 38 is pulled
from bore 48 of luer cap plug 40 to release and disengage luer cap plug 40
from plunger 20 with luer cap 14. (Spec. 9.)

Appeal 2011-003352
Application 12/409,133

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4. Figure 1 of Stevens is reproduced below.

Figure 1 of Stevens shows syringe discharge end 28, sealing cap 34
and luer lock connector 30. Sealing cap 34 is mounted on plunger tip 32 and
thus remains in the syringe and is not released with the luer cap 30. (Col. 5,
ll. 38-48.)

ISSUE
The Examiner concludes that Stevens teaches each element claimed.
Appellant argues that Stevens fails to disclose the following elements recited
in Claim 1:
1. “a luer cap releasably secured to a distal end of the
syringe body ... defining a fluid outlet.”

2. “a luer cap plug releasably supported on a distal end of
the plunger rod at a location distally of the sealing
member.”

3. “the luer cap plug being movable into the fluid outlet
of the luer cap upon advancement of the plunger assembly
from a retracted position to an advanced position to
establish a substantial seal within the fluid outlet.”

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Application 12/409,133

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(App. Br. 9-10.) Appellant further argues that, “Stevens' sealing cap 34 does
not move into the fluid outlet of the barrel 14 or the lock connector 30
(identified by the Examiner as the luer cap) and, thus, does not establish a
substantial seal within the fluid outlet.” (Id. at 11.) Appellant argues that,
“Stevens’ sealing cap 34 is not releasable from the plunger 12 during normal
use. In fact, if one were to try to remove Stevens' sealing cap 34 from
plunger 12, during use, one would have to first break the barrel 14 of the
syringe 10 to access the cap 34. This would necessarily render Stevens’
syringe 10 unusable.” (Id. at 10-11.)
The dispositive issue for each of the rejections is: Does the cited prior
art support the Examiner’s rejections by disclosing “a luer cap plug
releasably supported on a distal end of the plunger rod at a location distally
of the sealing member, the luer cap plug being movable into the fluid outlet
of the luer cap upon advancement of the plunger assembly from a retracted
position to an advanced position to establish a substantial seal within the
fluid outlet,” as claimed?

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
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Application 12/409,133

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burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of either anticipation or obviousness on the record before
us. The Examiner’s finding that the luer lock connector “is capable of being
releasably secured to a distal end of the syringe” (Ans. 15) does not
represent evidence that the specific luer lock connector of Stevens has the
capacity of being releasably supported and movable into the fluid outlet as
required by claims 1 and 17.
According to the Specification pages 2-3, “The luer cap plug is
movable into engagement with the luer cap to seal the fluid outlet of the luer
cap upon advancement of the plunger assembly from a retracted position to
an advanced position. The plunger assembly is configured to effect
disengagement of the luer cap from the distal end of the syringe body when
the plunger assembly is moved to the advanced position to provide a cap on
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an inlet end of an LV. catheter.” (See, Fig. 6, FF 3.) This allows “for
capping or sealing off the proximal end of the catheter without causing
reflux, thus obviating the need for reusable valve structures.” (Spec. 2.)
Appellant argues that Stevens, among other things, does not disclose
“a luer cap plug releasably supported on a distal end of the plunger rod at a
location distally of the sealing member, the luer cap plug being movable into
the fluid outlet of the luer cap upon advancement of the plunger assembly
from a retracted position to an advanced position to establish a substantial
seal within the fluid outlet,” as claimed. [Emphasis added.] More
particularly, Appellant argues that, “Stevens’ sealing cap 34 is not releasable
from the plunger 12 during normal use. In fact, if one were to try to remove
Stevens' sealing cap 34 from plunger 12, during use, one would have to first
break the barrel 14 of the syringe 10 to access the cap 34. This would
necessarily render Stevens’ syringe 10 unusable.” (App. Br. 10-11.)
We are persuaded by Appellant’s argument. We find that the
Examiner has failed to provide sufficient evidence that the sealing cap 34 of
Stevens is releasably supported on the distal end of the plunger rod such that
the luer cap plug moves into the fluid outlet of the luer cap upon
advancement of the plunger assembly from a retracted position to an
advanced position to establish a substantial seal within the fluid outlet,
consistent with its description in the Specification and as claimed.
Specification, Fig. 6 shows such a release of the luer cap plug into the luer
cap upon advancement of the plunger assembly.
For this reason, each of the anticipation and obviousness rejections is
reversed.

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CONCLUSION OF LAW
The cited references do not support the Examiner’s anticipation and
obviousness rejections.

REVERSED

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