Ex Parte Bailey et al

Board of Patent Appeals and Interferences

Nov 9, 2010

11455211 (B.P.A.I. Nov. 9, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/455,211 06/16/2006 Christopher G. Bailey IL-11430 8799
24981 7590 11/09/2010
Lawrence Livermore National Security, LLC
LAWRENCE LIVERMORE NATIONAL LABORATORY
PO BOX 808, L-703
LIVERMORE, CA 94551-0808
EXAMINER
STEELE, AMBER D
ART UNIT PAPER NUMBER
1639
MAIL DATE DELIVERY MODE
11/09/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHRISTOPHER G. BAILEY,
PERRY M. BELL, KODUMUDI S. VENKATESWARAN,
ALLEN T. CHRISTIAN, and ELIZABETH K. WHEELER
__________

Appeal 2010-004700
Application 11/455,211
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims to an
immunoassay apparatus. The Examiner made three anticipation rejections
and two obviousness rejections.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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We have jurisdiction under 35 U.S.C. § 6(b). We affirm one of the
anticipation rejections, but reverse the other two. We also affirm both
obviousness rejections.

STATEMENT OF THE CASE
Claims 1, 3, 4, and 6 stand rejected and are on appeal (App. Br. 3).2
Claim 1, 3, 4, and 6 read as follows:
Claim 1. An immunoassay apparatus for assaying a sample,
comprising:
a channel, said channel including a trapping area,
magnetic beads,
signal molecules connected to said magnetic beads,
a magnetic bead based reagent delivery unit connected to said
channel that delivers said magnetic beads and said signal molecules to
said trapping area of said channel,
a magnet operatively connected to said trapping area of said
channel,
a lysis unit connected to said trapping area of said channel,
a sample delivery unit connected to said trapping area of said
channel,
a magnetic bead based reagent,
at least one magnetic bead based reagent delivery unit
connected to said channel for delivering said magnetic bead based
reagent to said trapping area of said channel,
a wash,
at least one wash delivery unit connected to said channel for
delivering said wash to said trapping area of said channel,
a valve located outside of said trapping area and connected to
said channel,
and
an analysis unit located outside of said trapping area and
connected to said channel.

2 Appeal Brief filed September 10, 2009.
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Claim 3. The immunoassay apparatus of claim 1 wherein said
magnet is an Electromagnet.

Claim 4. The immunoassay apparatus of claim 1 wherein said
lysis unit is a photolysis unit connected to said trapping area of said
channel.

Claim 6. The immunoassay apparatus of claim 1 including a
waste unit located outside of said trapping area and connected to said
valve and connected to said channel.

The Examiner cites the following as evidence of unpatentability:
Ammann et al. US 6,335,166 B1 Jan. 1, 2002
Yamanishi et al. US 2003/0134416 A1 Jul. 17, 2003
Yamanishi US 6,949,355 B2 Sep. 27, 2005
Lee et al. US 2006/0110725 A1 May 25, 2006

The following rejections are before us for review:
(1) Claims 1, 3, 4, and 6, rejected under 35 U.S.C. § 102(a) as
anticipated by Lee (Ans. 3-4);3
(2) Claims 1, 3, and 6, rejected under 35 U.S.C. § 102(b) as
anticipated by Ammann (Ans. 4-5);
(3) Claims 1, 3, and 6, rejected under 35 U.S.C. §§ 102(a, b, or e) as
anticipated by Yamanishi ‘355 or Yamanishi ‘416 (Ans. 5-6);
(4) Claims 1, 3, 4, and 6, rejected under 35 U.S.C. § 103(a) as obvious
over Ammann and Lee (Ans. 7-8); and
(5) Claims 1, 3, 4, and 6, rejected under 35 U.S.C. 103(a) as being
unpatentable over Lee combined with either Yamanishi ‘355 or Yamanishi
‘416 (Ans. 8-10).

3 Examiner’s Answer entered December 26, 2009.
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ANTICIPATION -- LEE
ISSUE
Appellants contend that the Examiner erred in finding that Lee
anticipates the claimed apparatus because Lee’s device is “for purifying
nucleic acids by different laser absorption of beads; whereas Appellants’
claims describe an immunoassay apparatus for assaying a sample” (App. Br.
11). Appellants also argue:
[T]he Lee reference fails to disclose the following elements of
Appellants’ independent claim 1 which is the parent claim for
Appellants’ claims 3, 4, and 6:

Claim 1 “a magnetic bead based reagent delivery unit
connected to said channel that delivers said magnetic
beads and said signal molecules to said trapping area of
said channel,”

“at least one magnetic bead based reagent delivery unit
connected to said channel for delivering said magnetic
bead based reagent to said trapping area of said channel,”

“at least one wash delivery unit connected to said channel
for delivering said wash to said trapping area of said
channel,”

“a valve located outside of said trapping area and
connected to said channel,” or

“an analysis unit located outside of said trapping area and
connected to said channel”

(Id. at 11-12.)
Appellants further argue that the features of claims 3, 4, and 6 “are not
found in the Lee reference” (id. at 12).
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The Examiner responds that the asserted features are indeed found in
Lee, and cites the portions of Lee that allegedly describe those features (Ans.
10-13). Appellants reply that the PCR chamber of Lee’s apparatus is not an
analysis unit, and reiterate that Lee’s apparatus is directed to nucleic acid
purification, a different purpose than Appellants’ immunoassay apparatus
(Reply Br. 3-4).
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 Lee’s apparatus has (a) at least one
magnetic bead based reagent delivery unit as recited in claim 1, (b) at least
one wash delivery unit as recited in claim 1, (c) a valve as recited in claim 1,
(d) an analysis unit as recited in claim 1, (e) an electromagnet as recited in
claim 3, (f) a photolysis unit as recited in claim 4, and (g) a waste unit as
recited in claim 6.
FINDINGS OF FACT (“FF”)
1. Lee discloses “a nucleic acid purification apparatus for cells or
viruses” (Lee [0015]).
2. Figure 1 of Lee is reproduced below:

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Figure 1 “is a schematic diagram of a system where a magnetic bead
phase having PCR inhibitors bound thereto and a solid support phase having
nucleic acids bound thereto are separated after lysing cells using magnetic
beads and a laser beam” (id. at [0019]).
3. Referring to Figure 1, Lee discloses that its device has “a cell lysis
capillary having a sample inlet through which samples, magnetic beads, and
a solid support are introduced” (id. at [0015]).
4. As also seen in Figure 1, Lee’s device has a “washing buffer chamber
attached to the capillary “(id. at [0039]).
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5. As also seen in Figure 1, Lee’s device includes a “DNA amplification
[PCR] chamber connected to the cell lysis capillary through a channel which
is opened or closed by a valve” (id. at [0037]).
6. Lee discloses that, in its PCR chamber, “direct detection [of target
nucleic acids] through the real-time PCR method, etc. is also possible” (id.).
7. As also seen in Figure 1, Lee’s device includes a waste chamber
connected to the cell lysis capillary by a micro valve.
8. Lee discloses that its apparatus can be used to purify nucleic acids by
a method that includes the following steps:
injecting a solution containing cells or viruses in a capillary-
shaped container containing magnetic beads and a solid
support; operating a vibrator to mix the solution, the magnetic
beads and the solid support; irradiating a laser beam onto the
magnetic beads to disrupt the cells or viruses and binding
compounds in the resulting cell or virus lysate to the magnetic
beads and binding nucleic acids in the lysate to the solid
support; fixing the magnetic beads, to which the compounds in
the cell or virus lysate are bound, to a capillary-shaped
container wall by means of a magnetic force generator;
discharging the lysate which contains no magnetic bead; and
eluting nucleic acids from the solid support and neutralizing
them.

(Id. at [0016].)
PRINCIPLES OF LAW
For a reference to anticipate a claim, “[e]very element of the claimed
invention must be literally present, arranged as in the claim.” Richardson v.
Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236 (Fed. Cir. 1989).
With respect to claim interpretation, “where a patentee defines a
structurally complete invention in the claim body and uses the preamble only
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to state a purpose or intended use for the invention, the preamble is not a
claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997).
ANALYSIS
Appellants’ arguments do not persuade us that Lee’s apparatus lacks
the claimed features, arranged as recited in the claims.
In the instant case, while the preamble of claim 1 recites an
“immunoassay apparatus for assaying a sample,” the body of the claim
recites a structurally complete device. Thus, while it might be true that
Lee’s apparatus is disclosed as being useful for purifying nucleic acids (FF
1, 2), which is different than the claimed apparatus’ intended use, we are not
persuaded that the preamble-recited intended use distinguishes the claimed
apparatus from Lee’s device.
As Appellants argue, claim 1 requires the device to have “at least one
magnetic bead based reagent delivery unit connected to said channel for
delivering said magnetic bead based reagent to said trapping area of said
channel.” Claim 1 also requires the device to have a “magnetic bead based
reagent delivery unit connected to said channel that delivers said magnetic
beads and said signal molecules to said trapping area of said channel.”
We agree with the Examiner, however, that Lee’s apparatus meets
those requirements. Specifically, Lee’s apparatus has a central cell lysis
capillary that corresponds to claim 1’s channel (FF 2). Attached to the
central capillary is a sample inlet port that delivers the magnetic beads to the
central capillary (FF 3). Because this sample inlet port performs the precise
bead delivery function required by claim 1, we are not persuaded that the
Examiner erred in finding that Lee’s apparatus includes the magnetic bead
based delivery unit required by claim 1.
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As Appellants argue, claim 1 also requires the apparatus to include “at
least one wash delivery unit connected to said channel for delivering said
wash to said trapping area of said channel,” as well as a “valve located
outside of said trapping area and connected to said channel.” However, in
view of Lee’s disclosure that its apparatus has a washing buffer chamber
attached to the central capillary via a micro valve (FF 2, 4) we are not
persuaded that the Examiner erred in finding that Lee’s apparatus has these
features.
As Appellants argue, claim 1 also requires the apparatus to include
“an analysis unit located outside of said trapping area and connected to said
channel.” However, in view of Lee’s disclosure that its apparatus has a PCR
chamber attached to the central capillary via a micro valve (FF 2, 5) we are
not persuaded that the Examiner erred in finding that Lee’s apparatus has
this feature. In particular, Appellants’ argument notwithstanding (Reply Br.
3), given Lee’s explicit disclosure that its PCR chamber can be used for
direct detection of target molecules (FF 6), we are not persuaded that the
Examiner improperly considered Lee’s PCR chamber to be an analysis unit.
Accordingly, as Appellants’ arguments do not persuade us that the
Examiner erred in finding that Lee’s apparatus contains all of the features
required in claim 1, we affirm the Examiner’s rejection of that claim as
anticipated by Lee.
Moreover, in view of Lee’s express disclosure that the magnet used in
its apparatus is an electromagnet (FF 2), we also affirm the Examiner’s
anticipation rejection of claim 3 over Lee.
As Appellants argue, claim 4 requires the lysis unit of the apparatus of
claim 1 to be “a photolysis unit connected to said trapping area of said
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channel.” However, as is evident, Lee’s laser cell-lysing unit is connected
directly to the central capillary, which includes the magnetic bead trapping
area (FF 2; see also FF 8 (laser lyses cells by irradiating magnetic beads)).
We therefore also affirm the Examiner’s anticipation rejection of claim 4
over Lee.
Lastly, in view of Lee’s disclosure that its device includes a waste
chamber connected to the cell lysis capillary by a micro valve (FF 2, 7), we
also affirm the Examiner’s anticipation rejection of claim 6 over Lee.
ANTICIPATION -- AMMANN
ISSUE
Claims 1, 3, and 6 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Ammann (Ans. 4-5).
Among a number of other reasons, Appellants argue that the
Examiner erred in finding that Ammann anticipates claim 1 because
Ammann’s device does not have a “magnetic bead based reagent delivery
unit connected to said channel that delivers said magnetic beads and said
signal molecules to said trapping area of said channel” (App. Br. 16).
The Examiner responds that Ammann discloses an apparatus that
includes multi-tube units “MTUs” and specimen containers in fluid
communication with each other, thereby allowing reagent delivery into the
MTUs, the MTUs then being “robotically moved to the magnetic separation
wash stations or, alternatively, reagents can be added to the MTUs in the
magnetic separation wash stations via robotic pipettes (please refer to the
entire specification particularly Figures 3-8, 14, 21, 24-28; column 4, lines
30-67; column 5, lines 1-34; columns 38-44)” (Ans. 14).
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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 Ammann’s device includes a magnetic
bead based reagent delivery unit configured in the manner required by claim
1.
FINDINGS OF FACT
9. Ammann discloses an automated analyzer that simultaneously
performs multiple diagnostic assays, the analyzer including “multiple
stations, or modules, in which discrete aspects of the assay are performed on
fluid samples contained in reaction receptacles” (Ammann, abstract).
10. Ammann’s automated analyzer has stations for “automatically
preparing a specimen sample, incubating the sample at prescribed
temperatures for prescribed periods, pe[r]forming an analyte isolation
procedure, and ascertaining the presence of a target analyte. An automated
receptacle transporting system moves the reaction receptacles from one
station to the next” (id.).
11. Ammann discloses that initial specimen preparation is begun when an
automated pipette unit “456 moves to transfer target capture reagent,
preferably mag-oligo reagent, from a container 440 carried on the multi-axis
mixer 400 into each of the receptacle vessels 162 of the MTU 160. The
target capture reagent includes a support material able to bind to and
immobilize a target analyte” (id. at col. 26, ll. 23-30; see also Figures 4-6).
12. Ammann discloses that the automated pipette unit removes the target
capture reagent, which contains magnetic particles, from a first container,
and then deposits the reagent into a second container that holds the
biological specimen to be tested for a nucleic acid of interest:
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The pipette unit 456 lowers the pipette tip attached to the
tubular probe 457 into the container 440 and draws a desired
amount of target capture reagent into the pipette tip. The
pipette unit 456 then moves the probe 457 out of the container
440, the multi-axis mixer 400 resumes rotating, and the pipette
unit 456 moves to a position above opening 252 and the
specimen transfer station 255. Next, the pipette unit 456
descends, moving the pipette tip and the tubular probe 457
through the opening 252, and dispenses a required amount of
target capture (typically 100-500 μl) into one or more of the
receptacle vessels 162 of the MTU 160.

(Id. at col. 28, ll. 55-66; see also Figures 4-6).
13. Once the specimens have been lysed and the nucleic acids in the
sample adhered to the magnetic beads, the tubes containing the specimens
are transferred to the “[m]agnetic [s]eparation [w]ash [s]tations” (id. at col.
38, l. 11), which include fittings that allow tubes of washing buffer to access
the specimen containers (id. at col. 39, ll. 43-47), and aspirator hoses that
remove waste fluid from the specimen containers (id. at col. 39, l. 66,
through col. 40, l. 2).
14. In operation, the magnetic wash stations function by positioning
magnets adjacent to the tubes to fix the magnetic particles in place. With the
target nucleic acids adhered to the magnetic particles, the particles can be
washed with buffer and the waste buffer subsequently removed by aspiration
(id. at col. 41, ll. 24-43).
PRINCIPLES OF LAW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
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record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

ANALYSIS
We agree with Appellants that a preponderance of the evidence of
record does not support the Examiner’s finding that Ammann’s device
includes a magnetic bead based reagent delivery unit configured in the
manner required by claim 1.
We acknowledge, as the Examiner argues, that Ammann’s washing
solutions are fluidly connected to the magnetic bead-containing tubes when
they are positioned in the magnetic wash separation station (FF 13).
However, the magnetic beads themselves are delivered to the tubes using an
automated pipette which is not connected to the tubes in Ammann that
correspond to the channel recited in Appellants’ claim 1 (see FF 11-12).
Accordingly, because claim 1 requires the magnetic bead based
delivery unit to be connected to the channel, and because Ammann’s bead-
delivering pipettes are not connected to the tubes in Ammann’s device that
correspond to the claimed channel, we are not persuaded that Ammann
meets that feature. Therefore, as the Examiner has not adequately explained
how or why the features of Ammann’s device are configured in the manner
required in claim 1, we reverse the Examiner’s anticipation rejection of that
claim, and its dependent claims 3 and 6, over Ammann.

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ANTICIPATION -- YAMANISHI
ISSUE
Claims 1, 3, and 6 stand rejected under 35 U.S.C. §§ 102(a, b, or e) as
anticipated by Yamanishi ‘355 or Yamanishi ‘416 (Ans. 5-6).4
In view of the positions advanced by Appellants and the Examiner
(see, e.g., App. Br 20; see also Ans. 16-19), the issue with respect to this
rejection is whether the evidence of record supports the Examiner’s finding
that Yamanishi ‘355 describes an apparatus having all of the features in
claim 1, arranged in the manner recited in the claim.
FINDINGS OF FACT
15. Yamanishi ‘355 discloses “an automated system for processing a fluid
sample” (Yamanishi ‘355, abstract). The automated system includes “at
least one filtration chamber that comprises or engages one or more
microfabricated filters of the present invention; automated means for
directing fluid flow through the one or more filtration chambers of the
automated system, and means for collecting enriched rare cells” (id.).
16. Figure 14 of Yamanishi ‘355, reproduced below, “is a schematic
depiction of a filtration unit of [Yamanishi ‘355’s] invention” (id. at col. 5,
ll. 49-50):

4 It is undisputed that Yamanishi ‘355 is the patent that issued from the
application which was published as Yamanishi ‘416 (Ans. 5-6).
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Figure 14 shows
a valve-controlled inlet for the addition of sample (valve A in
FIG. 14), a valve connected to a conduit through which
negative pressure is applied for the filtration of the sample
(valve B in FIG. 14), a valve controlling the flow of wash
buffer into the filtration chamber for washing the chamber
(valve C in FIG. 14), and an additional valve-controlled outlet
for the exit of retained enriched cells from the chamber (valve
D in FIG. 14).

(Id. at col. 64, l. 62, through col. 56, l. 2.)
17. Figure 16A of Yamanishi ‘355 is reproduced below:

Figure 16A shows
the filtration unit having a loading reservoir (510) connected
through a valve (506) to a filtration chamber that comprises an
antechamber (504) separated from a post-filtration subchamber
(505) by a microfabricated filter (503). A wash pump (526) is
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connected to the lower chamber through a valve (508) for
pumping wash buffer (524) through the lower subchamber.
Another valve (507) leads to another negative pressure pump
used to promote fluid flow through the filtration chamber and
out through an exit conduit (530). A collection vessel (518) can
reversibly engage the upper chamber (504).

(Id. at col. 5, ll. 54-64.)
ANALYSIS
We are not persuaded that the Examiner has made a prima facie case
that claim 1 is anticipated by the Yamanishi references. As Appellants point
out, claim 1 requires the apparatus to include “a wash” and a “wash delivery
unit connected to said channel for delivering said wash to said trapping area
of said channel.”
The Examiner refers to a number of sections of Yamanishi ‘355 that
supposedly describe this feature (see Ans. 17-18). We have carefully
reviewed the portions of Yamanishi ‘355 cited by the Examiner. We are not
persuaded, however, that the Examiner has adequately explained how or
why Yamanishi ‘355 describes a wash delivery unit configured as claim 1
requires.
We acknowledge that Figure 14 of Yamanishi ‘335 shows an
embodiment of the device that has a loading reservoir with an adjacent
magnet that allows magnetic beads to be trapped in place (FF 16). However,
as seen in Figure 14, and explained in its supporting disclosure, the wash
solution pump (valve C) is not configured to deliver wash solution to the
magnetic bead trapping area, as Appellants’ claim 1 requires. Instead, the
wash solution is delivered to the device’s filtration chamber, which is
separated from the bead trapping area by valve A (FF 16).
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Unlike Figure 14, the embodiment shown in Figure 16 does not have a
magnet, and neither Figure 16 nor its supporting disclosure mentions
anything about magnetic beads (see FF 17). Also, the wash solution
delivered by the pump 526 and valve 508 is sent to the filtration subchamber
and antechamber (504 and 505), rather than the loading reservoir 510 which
corresponds to the magnetic bead-trapping area adjacent to the magnet
shown in Figure 14 (see FF 17). Thus, it is unclear how the conduits would
deliver the washing solution to the bead trapping area above the filtration
zone shown in Figure 16.
Similarly, the other portions of Yamanishi ‘355 cited by the Examiner
describe how the wash solution is delivered to the filtration chamber
(Yamanishi ‘355 col. 25, ll. 11-25; see also col. 64, ll. 52-67), rather than the
magnetic bead trapping area. Thus, given the actual teachings in the cited
sections of the reference, and the absence of any explanation from the
Examiner as to how or why an ordinary artisan would interpret those
teachings as describing a unit that delivers a wash to a channel that contains
a magnetic bead-trapping area, we are not persuaded that the Examiner has
made a prima facie case of anticipation with respect to claim 1.
We therefore reverse the Examiner’s anticipation rejection of claims
1, 3, and 6 over the Yamanishi references.
OBVIOUSNESS -- AMMANN AND LEE
Claims 1, 3, 4, and 6 stand rejected under 35 U.S.C. § 103(a) as
obvious over Ammann and Lee (Ans. 7-8).
As noted above, we agree with Appellants that Ammann does not
meet all of the limitations of claims 1, 3, and 6. However, as discussed with
respect to the anticipation rejection over Lee, we are not persuaded that
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Lee’s apparatus lacks the magnetic bead based reagent delivery unit, wash
delivery unit, valve, or analysis unit recited in claim 1, or the electromagnet
recited in claim 3, or the waste unit recited in claim 6.
Accordingly, Appellants’ arguments do not persuade us that the
Examiner erred in concluding that the combined disclosures of Ammann and
Lee teach all of the features of the rejected claims, nor are we persuaded that
an ordinary artisan lacked a reasonable expectation of successfully
combining the references’ teachings in the manner posited by the Examiner.
Moreover, given the Examiner’s explicit finding that an ordinary artisan
would have viewed an exchange of Lee’s photolysis unit for Ammann’s
chemical lysis reagents “the substitution of one known element . . . for
another” (Ans. 7), we do not agree with Appellants that the Examiner failed
to articulate a rationale for combining the references’ teachings.
Thus, as Appellants’ arguments do not persuade us that the Examiner
failed to make a prima facie case of obviousness, we affirm the Examiner’s
obviousness rejection of claims 1, 3, 4, and 6 over Ammann and Lee.
OBVIOUSNESS -- YAMANISHI AND LEE
Claims 1, 3, 4, and 6 stand rejected under 35 U.S.C. 103(a) as being
unpatentable over Lee combined with either Yamanishi ‘355 or Yamanishi
‘416 (Ans. 8-10).
As noted above, we agree with Appellants that the Yamanishi
references do not meet all of the limitations of claims 1, 3, and 6. However,
as discussed with respect to the anticipation rejection over Lee, we are not
persuaded that Lee’s apparatus lacks the magnetic bead based reagent
delivery unit, wash delivery unit, valve, or analysis unit recited in claim 1, or
the electromagnet recited in claim 3, or the waste unit recited in claim 6.
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Accordingly, Appellants’ arguments do not persuade us that the
Examiner erred in concluding that the combined disclosures of Yamanishi
‘355/’416 and Lee teach all of the features of the rejected claims, nor are we
persuaded that an ordinary artisan lacked a reasonable expectation of
successfully combining the references’ teachings in the manner posited by
the Examiner. Moreover, given the Examiner’s explicit finding that an
ordinary artisan would have viewed an exchange of Lee’s photolysis unit for
Yamanishi’s lysis reagents “the substitution of one known element . . . for
another” (Ans. 9), we do not agree with Appellants that the Examiner failed
to articulate a rationale for combining the references’ teachings.
Thus, as Appellants’ arguments do not persuade us that the Examiner
failed to make a prima facie case of obviousness, we affirm the Examiner’s
obviousness rejection of claims 1, 3, 4, and 6 over Yamanishi ‘355/’416 and
Lee.

SUMMARY
We affirm the Examiner’s rejection of claims 1, 3, 4, and 6 under 35
U.S.C. § 102(a) as anticipated by Lee.
However, we reverse the Examiner’s rejection of claims 1, 3, and 6
under 35 U.S.C. § 102(b) as anticipated by Ammann.
We also reverse the Examiner’s rejection of claims 1, 3, and 6, under
35 U.S.C. §§ 102(a, b, or e) as anticipated by Yamanishi ‘355 or Yamanishi
‘416.
We affirm the Examiner’s rejection of claims 1, 3, 4, and 6 under 35
U.S.C. § 103(a) as obvious over Ammann and Lee.
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We also affirm the Examiner’s rejection of claims 1, 3, 4, and 6 under
35 U.S.C. 103(a) as obvious over Lee combined with Yamanishi ‘355 or
Yamanishi ‘416.

TIME PERIOD
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

dm
LAWRENCE LIVERMORE
NATIONAL LABORATORY
PO BOX 808, L-703
LIVERMORE, CA 94551-0808