Ex Parte Niskanen et al

Patent Trial and Appeal Board

Apr 29, 2016

12557248 (P.T.A.B. Apr. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/557,248 09/10/2009 Aimo Niskanen
28213 7590 05/03/2016
DLA PIPER LLP (US)
4365 EXECUTIVE DRIVE
SUITE 1100
SAN DIEGO, CA 92121-2133
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.
ANill00-1 4048
EXAMINER
BROWN, MELANIE YU
ART UNIT PAPER NUMBER
1677
NOTIFICATION DATE DELIVERY MODE
05/03/2016 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):
gtdocket@dlapiper.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AIMO NISKANEN and MIKA SARAMAKI1
Appeal2013-006208
Application 12/557,248
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
uECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an immunochemical test strip. The Examiner rejects the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the Real Party in Interest is Ani Biotech Oy of
Helsinki, Finland. (App. Br. 3.)
Appeal2013-006208
Application 12/557,248
STATEMENT OF THE CASE
Claims 1-10 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. Claim 1 is representative of the claims on appeal and
can be found in the Claims Appendix of the Appeal Brief.
Appellants request review of the Examiners rejection of claims 1-10
under 35 U.S.C. § 103(a) over Verheijden2 in view of Gambert3 and further
in view of Kiser4 .
The Examiner position is that Verheij den "teach[ es] a porous carrier
comprising a layer of porous material that is paper . . . . Although
Verheijden ... do[ es] not specifically teach the wrapping torque of the
porous material around the solid support, it has long been settled to be no
more than routine experimentation for one of ordinary skill in the art to
discover an optimum value for a result effective variable." (Final Act. 45.)
The Examiner acknowledges that Verheijden does not disclose "the carrier
disposed around a solid support and the hydrophobic cover including vents
having a specific size and sufficient in number to equalize the pressure
within and without the porous carrier as sample fluid is applied thereto."
(Id. at 5.) The Examiner looks to Gambert for teaching a hydrophobic cover
(Id.), and to Kiser for teaching vents (Id. at 6).
Appellants contend that Verheijden's "porous carrier is not disposed
around a solid support and having a specifically defined wrapping torque"
2 Verheijden et al., US 5,760,315, issued June 2, 1998.
3 Gambert et al., US 6,416,715 Bl, issued July 9, 2002.
4 Kiser et al., US 5,719,034, issued Feb. 17, 1998.
5 Final Office Action mailed Nov. 22, 2011.
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Appeal2013-006208
Application 12/557,248
(App. Br. 5; see also IO) and neither Gambert nor Kiser remedy this
deficiency (id. at 10).
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of references discloses a
"porous carrier disposed around a solid support under a wrapping torque
from 0.05 to 0.5 Nm" as claimed?
Findings of Fact
FPL Fig 2 ofVerheijden, reproduced below, shows a sample collection
device comprising an absorbing material and at least one assay
reagent.
2--·f--i r1
i i l-~--6
iJ.
3··'"" ~·
~': .. ··~':, .......... ~ I ;
l,,_ L..J lo _,_.,l.--·-'0
L" _____ ,~~:>
FIG. 2
Figure 2, shows a device that contains "a handle 8, a top section 1
containing a top end 4 and an elongated part 5 which fits into the
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Appeal2013-006208
Application 12/557,248
interior space 6 of section 2." (Verheijden col. 7, 11. 14--16.) "The
elongated part 5 of section 1 is impregnated with the assay reagent
(labeled specific binding reagent)." (V erheij den col. 7, 11. 21-23)
FF2. Verheijden teaches various absorbing materials.
The absorbing material of the sample collection device can
readily absorb test liquid, but also easily release this test liquid
for example under mechanical pressure or capillary transfer. It
can thus be a sponge-like material such as, for example, cotton
wool, woven and non-woven materials, fibers bonded by
extrusion, paper and paper-like materials. Preferably porous
sintered hydrophilic and hydrophilized materials are used, such
as hydrophilized polyethylene vinylacetate as well as other
hydrophilized polyesters, hydrophilized polypropylene,
hydrophilized polyethylene and hydrophilized ultra high
molecular weight polyethylene.
(Verheijden col. 5, 11. 19-29; Ans. Final Act. 4.)
FF3. Gambert discloses "a device for collecting and releasing saliva for
diagnostic purposes." (Gambert col. 1, 11. 5---6.) Fig. 1, reproduced
below, shows such a collecting device.
'.1
Fig. 1
Fig. 1 shows a lateral cross section of the collecting device.
Said porous unit 1 is displaceably arranged in a receptacle, in
the present example in a bellow 20. The bellow 20 is provided
with a closed end-portion 21 and an end-portion 22 that can be
opened. A locking cap 3 is adapted for fitting on said end-
portion 22. The interior wall of the porous unit 1 is provided
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Appeal2013-006208
Application 12/557,248
with a supporting means which, in the present example, is
embodied by a drainage tube 41. Opening 42 are
circumferentially distributed over a part of said drainage tube
41.
(Gambert col., 2, 11. 3-10; Ans. 8 ("the support is still considered solid
because the material is non-porous and impermeable to fluid, in order
to provide a drainage tube for the porous material".)
FF4. Fig. 7 of Gambert shows an alternate geometry of the collection
device.
'2 l'
2
Fig. 7
"FIG. 7 shows a perspective partial view ... here the porous unit 1 is
of circular cross-section and the further components are adapted to
this geometry." (Gambert col. 3, 11. 53-57.) The cross section shows
a supporting means 4' that is worked into the upper circumference of
unit 1, and connected to the slider 11, a sleeve 12 and a receptacle 2.
(See Gambert col. 3, 11. 26-32; see also col. 4, 11. 33-58.)
FF5. Kiser discloses a test strip with the membrane matrix sandwiched
between two cover sheets. (Kiser col. 11, 11. 45--46; Ans. 6.)
"optional vent holes 28 facilitate the spread of sample along the strip."
(Kiser col. 11, 11. 53-54; see Ans. 6.)
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Appeal2013-006208
Application 12/557,248
FF6. The Specification provides:
The polyester material was cut in 25 mm x 27 mm pieces. Four
layers of the porous material was rolled around a round hollow
stick made of polypropylene and attached with a tape under a
wrapping torque of 0.1 Nm. The tape was first attached to the
polypropylene stick and then rolled with the polyester around
the stick and finally the tape was attached to itself to form a
protective cover over the porous material. As the tape (25 mm
x 51 mm) was wound around each stick constructed, it was
punctured 80-120 times with needles to form vents therein,
each having a diameter that varied among the vents between 0.1
and 0. 5 mm.
(Spec. i-f 51.) The hydrophobic cover "may be comprised of a clear
polyester tape, mylar film, or other impermeable material." (Spec.
,-r 30.)
Principle of Law
"An examiner bears the initial burden of presenting a prima facie case
of obviousness." In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
Analysis
We find Appellants have the better position. Although the
Specification does not provide a specific definition of wrapping torque, the
example described explains that the combination of tape, such as polyester
tape or mylar film, in conjunction with the porous material is wound around
a solid object with a particular force (FF6). This is similar to applying an
ace bandage around an appendage, where after the bandage is secured the
bandage continues to apply pressure to the wrapped area underneath the
bandage. Accordingly, we interpret the phrase "wrapping torque" in light of
the Specification as the application of force onto the porous material.
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Appeal2013-006208
Application 12/557,248
While the Examiner points to the disclosure of Verheijden as
suggesting that the collection material may include "woven and non-woven
materials, fibers bonded by extrusion, paper and paper-like materials" (FF2;
see Final Act. 4), the disclosure of Verheijden does not provide any teaching
with respect to any kind of wrapping torque achieved with the use of the
disclosed paper material. The Examiner asserts that "wrapping torque is a
necessary property when a porous material is disposed around a solid
support" (Ans. 11 ), however, the Examiner does not provide evidence
supporting that point. Although the use of paper-like material as an
absorbing material is contemplated in Verheijden's disclosure, the preferred
porous material is sintered6 material. There is nothing in Verheijden that
teaches the porous absorbing material should be placed and maintained
under any kind of pressure to be effective. Thus, even if the materials of
Verheijden are placed around a solid support as suggested by the Examiner,
the Examiner has not pointed to any teaching in Verheijden, Gambert, or
Kiser that recognizes that wrapping torque or pressure on the absorbing
materials is needed. The Examiner has not directed us to any teaching in the
references that recognizes pressure is needed and suggests itself for
optimization. As stated in Antonie, while discovery of an optimum value of
a variable is normally obvious, one exception to this rule is the situation
6 Sinter is defined as 1.) Geology A chemical sediment or crust, as of porous
silica, deposited by a mineral spring. 2.) A mass formed by sintering. To
cause (metallic powder, for example) to form a coherent mass by heating
without melting. To form a coherent mass by heating without melting. Free
Dictionary, http://www.thefreedictionary.com/sintered, (last visited April 25,
2016).
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Appeal2013-006208
Application 12/557,248
where the parameter optimized was not recognized to be a result-effective
variable. See In re Antonie, 559 F .2d 618, 620 (CCP A 1977).
The evidence of record does not support the Examiner's conclusion
that the combination of Verheijden, Gambert and Kiser render obvious the
porous carrier warped around the solid support with a wrapping torque from
0.05 to 0.5Nm.
SUMMARY
We reverse the rejection of claims 1-10 under 35 U.S.C. § 103(a)
over Verheijden, Gambert, and Kiser.
REVERSED
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