Ex Parte Matson et al

Patent Trial and Appeal Board

Nov 24, 2014

12239103 (P.T.A.B. Nov. 24, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte SCOTT MATSON and RICHARD BRAGA
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Appeal 2012-006682
Application 12/239,103
Technology Center 3700
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Before DONALD E. ADAMS, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1–18 (App. Br. 5).
Examiner entered rejection under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The claims are directed to a medical catheter assembly and dialysis
catheter. Claim 1 is representative and is reproduced in the Claims
Appendix of Appellants’ Brief.

1 The Real Party in Interest is Tyco Healthcare Group LP (App. Br. 3).
Appeal 2012-006682
Application 12/239,103

2
Claims 1–18 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Fenton2 and Mahurkar.3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Fenton suggests a catheter as illustrated in Fenton’s Figures 5B and
6:

“FIG. 5B shows in longitudinal cross-section . . . a dual lumen catheter,
wherein each lumen has an associated valve assembly [12]” (Fenton, col. 3,
ll. 54–58). “FIG. 6 is a perspective view of a dual lumen catheter, where
each lumen has two associated valve assemblies [12]” (id. at ll. 59–61).
FF 2. Fenton suggests a catheter that “has an open first or proximal end . . .
and a closed second or distal end 16, and is adapted for inflow (infusion) of
fluid from [the] proximal end . . . to a point near distal end 16 and into a
patient’s bloodstream” . . . or “outflow (aspiration) of fluid from the
patient’s bloodstream from a point near distal end 16 to [the] proximal end”
(Fenton, col. 4, ll. 9–12).

2 Fenton, Jr., US 5,224,938, issued July 6, 1993.
3 Mahurkar, US 4,583,968, issued Apr. 22, 1986.
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FF 3. Fenton suggests that flow into or out of the catheter’s lumen is based
on a pressure differential across slit 22 of the valve assembly 12 and that
valve assembly 12 has “a uniform seal . . . to prevent fluid flow out of or
into the lumen 20” at a neutral pressure (Fenton, col. 4, ll. 21–44; col. 7, ll.
31–40; col. 4, ll. 49–62).
FF 4. Examiner finds that Fenton fails to suggest a catheter with an open
distal end (Ans. 6).
FF 5. Mahurkar “relates to surgical instruments for withdrawing fluids
from or introducing fluids into a cavity of the body” (Mahurkar, col. 1, ll.
10–12).
FF 6. Mahurkar’s Figures 1 and 7 are reproduced below:

“FIG. 1 is a front elevational view of a smooth bore double lumen catheter
according to [Mahurkar’s] invention” (Mahurkar, col. 2, ll. 52–54). “FIG. 2
is a right side elevational view of the smooth bore double lumen catheter
illustrated in FIG. 1” (id. at ll. 55–56). “FIG. 7 is a view in section of the
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Application 12/239,103

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smooth bore double lumen catheter illustrated in FIG. 1 taken along long 7–-
7 shown in FIG. 2” (id. at ll. 66–68).
FF 7. Mahurkar suggests that
The hollow tube 11 includes openings or apertures at the
distal end portions of the lumens 13, 14 to permit the flow of
fluid between a body cavity (not shown) and the lumens. The
return lumen 13 extends along the entire length of the tube 11
to an aperture or opening 18 at the distal end or tip of the tube
11 as is more clearly shown in FIG. 7. The inlet lumen 14 is
shorter than the return lumen 13 and terminates at its distal end
at an aperture or opening 19 that is in the side of the tube 11
and is substantially displaced from the aperture 18 at the distal
end of the tube 11.
(Mahurkar, col. 3, ll. 36–46.)
FF 8. Mahurkar suggests that “[t]he relatively small size of the return and
inlet apertures 18, 19 . . . reduce insertion trauma, but they also impede fluid
flow. Therefore, an additional group of holes or apertures generally
designated 21 connect the return lumen 13 to the outer surface of the tube
11, and an additional group of holes or apertures 22 connect the inlet lumen
14 to the outer surface of the tube 11” (Mahurkar, col. 3, l. 65–col. 4, l. 3).
ANALYSIS
Based on the combination of Fenton and Mahurkar, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to provide alternate flow paths since Fenton calls
for an embodiment having a plurality of openings” (Ans. 6). We are not
persuaded.
As Appellants explain, “Fenton’s device requires a closed end to
create the pressure differential between the lumen 20 and the outer surface
of the tubular element 18 to selectively enable or disable fluid flow in a
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single direction” (App. Br. 16; Reply Br. 5; see also FF 1–3). While
Examiner is correct in recognizing that the distal end of Mahurkar’s catheter
is open, unlike Fenton, Mahurkar’s device has distinct inlet 14 and return 13
lumens that do not rely on a pressure differential inside the lumen of the
device to open/close or otherwise redirect valves on the device (FF 6–8; Cf.
FF 1–3).
Obviousness requires more than a mere showing that the
prior art includes separate references covering each separate
limitation in a claim under examination. KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d
705 (2007). Rather, obviousness requires the additional
showing that a person of ordinary skill at the time of the
invention would have selected and combined those prior art
elements in the normal course of research and development to
yield the claimed invention. Id. at 421, 127 S.Ct. 1727.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011). On this record, Examiner failed to establish an evidentiary basis to
support a conclusion that a person of ordinary skill in this art would have
found it obvious to open the distal end of Fenton’s device, as in Mahurkar,
when Fenton’s device operates on a pressure differential created inside the
device due to the closed distal end of Fenton’s device and Mahurkar’s does
not (see FF 1–3).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1–18 under
35 U.S.C. § 103(a) as unpatentable over the combination of Fenton and
Mahurkar is reversed.
REVERSED
cdc