Ex Parte Fulton et al

Board of Patent Appeals and Interferences

Mar 16, 2010

11188535 (B.P.A.I. Mar. 16, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SCOTT P. FULTON, ROBERT J. SAKOWSKI, and
WILLIAM BOWERS
__________

Appeal 2009-0124821
Application 11/188,535
Technology Center 1600
__________

Decided: March 17, 2010
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Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH,
Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an apparatus for
conducting an immunoassay or selective adsorption separation. The
Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 “The real party in interest is BioSystem Development, LLC” (App. Br. 1
(entered January 16, 2009)).
Appeal 2009-012482
Application 11/188,535

STATEMENT OF THE CASE
Claims 1 and 2 are pending and on appeal (App. Br. 1). Claim 1 is
representative and reads as follows:
1. Apparatus for conducting an immunoassay or
selective adsorption separation, the apparatus comprising:
an assay unit having a passage formed in its center to
form a packed bed;
porous bed supports mounted in the assay unit at opposite
ends of the packed bed;
solid phase support beads located in the packed bed and
having a reaction reagent mounted on their surface;
an outlet from the assay unit having an outer diameter
and located below the packed bed;
two frusto-conical sealing surfaces on an upper surface of the
assay unit above and opening into the packed bed; and
a frusto-conical sample cup positioned between the two
frusto-conical sealing surfaces, wherein the sample cup has a
volume of from about 5 to about 100 μL;
wherein the two frusto-conical sealing surfaces comprise
an upper sealing surface dimensioned to form a fluid-tight,
friction seal with a pipette holder, and a lower sealing surface
abutting the packed bed and dimensioned to form a fluid-tight,
friction seal with a device selected from the group consisting of
straight wall tubing have an outer diameter of from about 0.75
to about 1 mm, hypodermic needles having a gauge of from
about 19 to 21, and pipette tips having a volume of from about
10 μL to about 200 μL; and
wherein the outer diameter of the outlet from the assay
unit is dimensioned to form a fluid-tight, friction seal with the
lower sealing surface when two assay units are nested together.

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The sole rejection before us for review is the Examiner’s rejection of
claims 1 and 2 under 35 U.S.C. § 103(a) as being obvious in view of Cook2
and Gjerde3 (Ans. 4-9).
OBVIOUSNESS
ISSUE
The Examiner finds that Cook discloses an apparatus having the
features recited in claim 1, except for an outer diameter dimensioned to form
a fluid tight friction seal with the lower sealing surface when two assay units
are nested together (see Ans. 4-7). The Examiner reasons, however, that an
ordinary artisan would have considered it obvious to configure Cook’s upper
and lower assay units in that manner in view of Gjerde’s disclosure of the
desirability of small sample volumes in assay units of the type disclosed in
Cook (id. at 8).
The Examiner also concedes that Cook differs from claim 1 with
respect to the volume of the sample cup, but reasons that it “would have
been [an] obvious matter of design choice to select the assay device
geometry to have the sample cup volume of from about 5 to about 100 μL as
recited in the instant claims, since such a modification would have involved
a mere change in the size of the component” (id.).
Appellants contend that the Examiner was incorrect in finding that
Cook’s device included a number of the claimed features, including upper
and lower sealing surfaces having the configuration recited in claim 1 (App.
Br. 3). In particular, Appellants urge, “the ‘lower sealing surface’ (reference

2 Cook et al., U.S. Patent No. 6,761,855 B1 (filed Nov. 5, 2001).
3 Gjerde et al., WO 2004/007081 A1 (published Jan. 22, 2004).
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numeral 70 or 20) as asserted by the Office does not ‘abut’ the packed bed
as required by the present claims” (id. at 6).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports the Examiner’s finding that Cook’s device includes upper and
lower sealing surfaces encompassed by claim 1.
FINDINGS OF FACT (“FF”)
Claims and Specification
1. Claim 1 recites an apparatus for conducting an immunoassay or
selective adsorption separation. The claimed apparatus has “two frusto-
conical sealing surfaces on an upper surface of the assay unit above and
opening into [a] packed bed.”
The upper sealing surface is “dimensioned to form a fluid-tight,
friction seal with a pipette holder,” and the lower sealing surface “abut[s] the
packed bed” and is dimensioned to form a fluid-tight, friction seal with
either (a) straight wall tubing have an outer diameter of about 0.75 to about 1
mm, or (b) hypodermic needles having a gauge of from about 19 to 21, or (c)
pipette tips having a volume of from about 10 μL to about 200 μL.
Claim 1 also requires the outer diameter of the outlet to be
dimensioned so as to form a fluid-tight, friction seal with the lower sealing
surface when two assay units are nested together.
2. Appellants’ Figure 1, reproduced below, shows an example of a
device encompassed by claim 1:

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Figure 1 shows device 1, which contains packed bed 2 contained
between porous supports 3 (Spec. [00063]). Also shown in Figure 1 is lower
sealing surface 5, “which is frusto-conical in shape and has an inlet diameter
6, an outlet diameter 7 and a length 8 carefully defined to enable standard
small volume pipette tips and standard gauge hypodermic needles and tubing
to connect in a fluid-tight seal by simple insertion” (id. at [00064]).
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As shown, lower sealing surface 5 is immediately adjacent to the
packed bed 2.
3. Appellants’ Figure 1 also shows upper sealing surface 10, which “is
another frusto-conical sealing surface sized to fit and seal on the distal end
of a standard 200 μL laboratory pipette (i.e. is shaped identically to the
proximal end of a standard 200 μL pipette tip)” (id.).
4. Appellants’ Figure 1 also shows, between upper sealing surface 10
and lower sealing surface 5 “another frusto-conical chamber serving as a
sample cup 9, which has a volume designed to hold typical required amounts
of samples or reagents, typically ranging from 5 to 100 μL” (id.).

The Prior Art
Cook
5. Cook discloses “a column for use in solid phase processing including
solid phase synthesis and purification of complex chemicals such as
oligonucleotides and the like” (Cook, col. 1, ll. 5-8).
6. Figures 2 and 3 of Cook are reproduced below:
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Figure 2 shows a “cross-sectional view of [Cook’s] column . . .
illustrating a solid support contained in the column,” and Figure 3 “is a
cross-sectional view illustrating the connection of a pair of columns in
series” (id. at col. 3, ll. 20-24).
7. As seen in Figure 2, column 10 decreases in size from the upper to
lower end, and at the upper end has “a relatively large upper or top orifice 14
to provide a sufficient target such that a fluid line or a multiple fluid line
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bundle may dispense fluids into the column 10 with great efficiency” (id. at
col. 3, ll. 36-39).
8. Also seen in Figure 2 is “upper cavity portion 20 which desirably has
internal dimensions rendering it compatible with dispensing pippetors [sic],
so that it can be used as a pipette tip or a pipettor can be used to aspirate the
column 10” (id. at col. 3, ll. 48-52).
9. Also seen in Figure 2 is central cavity portion 30 which “typically is
smaller in diameter than the upper cavity portion 20. . . . The uniform
cross-section of the central cavity portion 30 conveniently allows the sealing
of the solid support 52 by the upper frit 50 at varying levels as determined
by the amount of solid phase resin” (id. at col. 3, l. 62 through col. 4, l. 11).

Gjerde
10. Gjerde discloses extraction columns for purifying analytes such as
peptides, proteins, or nucleic acids “characterized by the use of low dead
volume columns, which is achieved in part by the use of low pore volume
frits (e.g., membrane screens) to contain a bed of extraction media in the
column” (Gjerde, abstract).
11. According to Gjerde, low dead volume “facilitates the elution of the
captured analyte into a very small volume of desorption solution, allowing
for the preparation of low volume samples containing relatively high
concentrations of analyte” (id.).
12. Figure 2 of Gjerde, reproduced below, illustrates one method by
which Gjerde minimizes dead volumes:
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Figure 2 shows an embodiment “constructed from a frustoconical
upper tubular member . . . and a frustoconical lower tubular member . . .
engaged therewith . . . in a telescoping relation” (id. at 28).
13. Gjerde’s Figure 2 also shows membrane screen 10, which is bonded to
and extends “across the tip of the engaging end of the upper tubular member
and constitutes the upper frit of the extraction column. Another membrane
screen 14 is bonded to and extends across the tip of the lower tubular
member and constitutes the lower frit of the extraction column” (id.).
14. Gjerde explains:
The pore volume of the membrane screens 10 and 14 is
low to minimize the dead volume of the column. The sample
and desorption solution can pass directly from the vial or
reservoir into the bed of extraction media. The low dead
volume permits desorption of the analyte into the smallest
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possible desorption volume, thereby maximizing analyte
concentration.

(Id.)
PRINCIPLES OF LAW
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question. The Court nonetheless reaffirmed that “a patent
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
prior art.” Id. at 418.
Rather, as the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
Ultimately, therefore, as our reviewing court has stated, “[i]n
determining whether obviousness is established by combining the teachings
of the prior art, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art.” In re GPAC Inc.,
57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted).

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ANALYSIS
We agree with Appellants that the evidence of record does not support
the Examiner’s finding that Cook’s device includes a lower sealing surface
encompassed by claim 1. As noted above, claim 1 requires the claimed
apparatus to have two frustoconical sealing surfaces: an upper sealing
surface “dimensioned to form a fluid-tight, friction seal with a pipette
holder,” and a lower sealing surface that “abut[s] the packed bed.”
The Examiner identifies in Cook “lower sealing surface (reference
element 20 in Fig. 2) . . . that [renders] the assay unit . . . capable of making
fluid-tight contact with different devices without liquid contamination”
(Ans. 6). The Examiner also argues:
With respect to the limitation of “the lower sealing
surface abutting the packed bed and dimensioned to form a
fluid tight friction seal with a straight wall tubing having an
outer diameter of from about 0.75 to about 1 mm,” Cook et al.
teaches that the lower portion of the assay unit has diameter
smaller than the upper portion of the assay unit (column 2, lines
48-53). Cook et al. further teaches that in some embodiments,
the upper portion of the assay unit has a diameter smaller than 9
mm (column 3, lines 41-47). The lower portion, which includes
lower sealing surface of the assay unit abutting the packed bed,
would have a diameter smaller than 9 mm, which encompasses
the range of the lower sealing surface having a diameter of
about 0.75 mm to about 1 mm. Therefore, the dimension of
lower sealing surface of the assay unit of Cook et al. would be
capable of forming a fluid tight friction seal with a straight wall
tubing having an outer diameter of from about 0.75 to about 1
mm.

(Id. at 6-7.)
The Examiner’s arguments do not persuade us that Cook’s device
meets the requirement in claim 1 that the lower frustoconical sealing surface
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“abut[s] the packed bed.” As seen in Figure 2 of Cook, element 20 of
Cook’s device is a significant distance away from element 54, the porous frit
holding Cook’s packed bed 52 in place (FF 6), and therefore cannot
reasonably be considered to abut the packed bed. This is also true, even if
an ordinary artisan were to consider the undesignated beveled portion of
Cook’s device immediately below element 20 to be a frustoconical sealing
surface (see id.).
It is true, as the Examiner appears to argue, that the surfaces of central
cavity portion 30 are adjacent to the elements of Cook’s packed bed, and
might serve as a sealing surface. However, claim 1 specifies the sealing
surfaces as being frustoconical. In contrast, Cook discloses that central
cavity portion 30 has a uniform cross section that “conveniently allows the
sealing of the solid support 52 by the upper frit 50 at varying levels as
determined by the amount of solid phase resin” (FF 9).
The Examiner points out that Cook includes an embodiment in which
one of its devices is inserted inside another (see Cook, Fig. 3), and argues
that
Given the teachings of Gjerde et al., it would have been prima
facie obvious to one of ordinary skill in the art at the time of the
invention to have the tip of the upper assay unit of Cook et al.
in contact with the packed bed of the lower assay unit, which
would have a volume between the lower sealing surface and the
packed bed is less than about 2 microliters, as taught by Gjerde
et al. in order to purify an analyte from a sample solution using
low dead volume assay units.

(Ans. 17.)
Thus, as we understand it, the Examiner’s position is that Cook meets
the requirement of a lower sealing surface abutting the packed bed when one
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of Cook’s devices is inserted inside another, as shown in Cook’s Figure 3
(FF 6). We are not persuaded.
When one of Cook’s devices is inserted into another, element 20 of
the outer device, originally designated by the Examiner as the lower sealing
surface, would be separated from the packed bed of the inner device by the
walls of the inner device. We do not agree that such an arrangement would
reasonably be considered “abutting” as required by claim 1. This separation
would be present even if the inner device was inserted nearly all the way
into the outer device as taught by Gjerde (FF 12).
Thus, it may be true that Gjerde discloses the usefulness of inserting
Cook’s inner device into an outer device such that the tip of the inner device
abuts the packed bed of the outer device (FF 10-14). However, the
Examiner has not adequately explained how doing that would result in a
device with a frustoconical lower sealing surface that abuts a packed bed, as
recited in claim 1. Nor has the Examiner explained why any other teachings
in either of the cited references would have prompted an ordinary artisan to
produce an apparatus having the claimed features arranged as recited in the
claim.
In sum, we agree with Appellants that the evidence of record does not
support the Examiner’s finding that Cook’s device includes upper and lower
sealing surfaces encompassed by claim 1. As the Examiner has not shown
that a device having all of the features recited in claim 1 would have been
obvious to an ordinary artisan, we reverse the Examiner’s rejection of claim
1, and its dependent, over Cook and Gjerde.

REVERSED
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cdc

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