Ex Parte Nurmi et al

Patent Trial and Appeal Board

Sep 23, 2013

10579137 (P.T.A.B. Sep. 23, 2013)

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.
10/579,137 05/15/2006 Jussi Nurmi TUR-181 3667
32954 7590 09/23/2013
JAMES C. LYDON
100 DAINGERFIELD ROAD
SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
MUMMERT, STEPHANIE KANE
ART UNIT PAPER NUMBER
1637
MAIL DATE DELIVERY MODE
09/23/2013 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JUSSI NURMI and TEEMU KORPIMAKI
____________

Appeal 2012-003105
Application 10/579,137
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims directed to
nucleic acid quantitative or qualitative analysis using a filter retention
system to collect analyte. The Patent Examiner has rejected the claims for
anticipation. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants state that the Real Party in Interest is Abacus Diagnostica Oy, a
Finnish Corporation. (App. Br. 1.)
Appeal 2012-003105
Application 10/579,137

2
STATEMENT OF THE CASE
The Specification provides that:
The object of the present invention is to provide simple,
fast and cost-effective sample preparation that is amenable to
automation as well as manual operation that allows purification
and concentration of e.g. biological nucleic acid or protein
analytes from biological, environmental or other liquid or
gaseous samples. Gaseous and liquid samples are suitable as
such whereas solid samples have first to be suspended in a
liquid.
(Spec. 9, ll. 17-23.)
Claims 18, 19, and 21-30 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief (App. Br. A1-A4). Claim 18 is
representative of the claims on appeal, and reads as follows:
18. A nucleic acid amplification assay for quantitative and/or
qualitative analysis of the presence of a specific analyte or
specific analytes in a sample, which analytes, if present, are
contained in biological particles of said sample, said assay
comprising
forcing said sample in a first direction through a filter
which retains said biological particles,
removing biological particles from said filter by a flush
flow in a second direction opposite said first direction, and
analyzing biological particles contained in said flush flow
by means of a nucleic acid amplification assay,
wherein said flush flow is analyzed for the analyte or
analytes without any purification.
The following ground of rejection is before us for review:
The Examiner has rejected claims 18, 19, and 21-30 as anticipated
under 35 U.S.C. § 102(e) over Daridon.2

2 Antoine Daridon, 2004/0229349 Al, published Nov. 18, 2004.
Appeal 2012-003105
Application 10/579,137

3
As Appellants do not argue the claims separately, we focus our
analysis on claim 18, and claims 19 and 21-30 stand or fall with that claim.
37 C.F.R. § 41.37 (c)(1)(vii).

The Issue: Anticipation
The Examiner’s position is that Daridon disclosed placing biological
particles onto a filter by “forcing said sample in a first direction through a
filter that retains said biological particles” (Ans. 5) followed by “removing
biological particles from said filter by a flush flow in a second direction
opposite said first direction, and analyzing biological particles contained in
said flush flow” (id.). The Examiner finds that the biological sample in the
flush flow is analyzed, and one such analysis includes using PCR
amplification (id.). The Examiner concludes that Daridon disclosed all the
steps set out in claim 18 and thereby anticipates the claim (id. at 4-11).
Appellants contend that Daridon does not arrange or combine the
system with all limitations as claimed (App. Br. 9). Appellants also contend
that Daridon fails to disclose nucleic acid amplification on a reverse flush
flow without further purification (id. at 5). “This affirmative ‘no
purification’ requirement is nowhere disclosed in Daridon.” (Id. at 6.)
The issue is: Does the evidence of record support the Examiner’s
finding that Daridon anticipates the claims?

Findings of Fact
FF 1. We adopt the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer; and
repeat the following findings for discussion purposes.
App
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Appeal 2012-003105
Application 10/579,137

5
FF 3. Daridon disclosed single cell assays:
Microfluidic systems may be used to perform single-cell
assays, which generally comprise any assays that are preferably
or necessarily performed on one cell at a time. Examples of
single cell assays include patch-clamp analysis, single-cell
PCR, single-cell fluorescence in situ hybridization (FISH),
subcellular distribution of a protein, and/or differentiation
assays (conversion to distinct cell types). . . . In other cases,
single-cell assays may require retention of a single cell, for
example, when the cell is lysed before the assay.
(Daridon, 19: ¶¶0307-0308 (emphasis added); Ans. 10, citing single cell
assay heading at ¶ 0307.)

Principle 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).
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005).

Analysis
Appellants contend that Daridon does not arrange or combine the
system with all limitations in the same way as claimed (App. Br. 9).
Appellants contend that “Daridon merely discloses that PCR is one of
several detection methods which can be used in conjunction with its
microfluidic systems (paragraph [0246]). There is no discussion linking
PCR and the specific particle retention and reverse flow steps disclosed in
paragraph [0449] and Fig. 18 of Daridon.” (Id. at 18.) Appellants cite
Appeal 2012-003105
Application 10/579,137

6
several cases in support of their position that anticipation can only be found
if the prior art discloses all the claim limitations if they are arranged or
combined in the same way as recited in the claim. See Therasense, Inc. v.
Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010), quoting Net
MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (Id.
at 9.)
We are not persuaded. Claim 18 recites three positive steps. Step (a)
retains the particles on a filter, step (b) removes particles from filter, and
step (c) analyzes particles using a nucleic acid amplification assay. Daridon
disclosed the use of a microfluidic device that loads a particle, such as a cell,
from a sample onto the filter, followed by repositioning the particle into the
analysis chamber (FF 2). The repositioning of the particle is achieved by
flowing fluid in the opposite direction over the filter (FF 2). Once the
particle is delivered to the analysis site, reagents can be delivered to the
analysis site to perform an analysis (FF 2). The particular section of
Daridon example 5 (Daridon 29: ¶¶ 0439-0453), cited by the Examiner,
disclosed the requisite steps of retaining a particle on the filter, removing the
particle from the filter, and analyzing the fluid containing the particle (FF 2).
“After particle 620 is delivered . . . additional fluidic lines may be used to
deliver reagents to analysis site 632, or analysis site 632 may be a blind
channel that is preloaded with such reagents” (FF 2). The disclosure of
Daridon relied on by the Examiner supports the step of performing an
analysis on the collected and relocated particle (FF 2). Daridon does not
spell out the specific type of analysis to be performed on the collected and
repositioned cell (FF 2) but does provide a list of the kind of assays that can
be performed at the analysis step.
Appeal 2012-003105
Application 10/579,137

7
The facts in the present case differ from the facts in Net MoneyIN.
Daridon disclosed all three positively recited steps of claim 18 in a single
example. In Net MoneyIN to arrive at the claimed invention required the
combination of two separate protocols, each of which contained only a
subset of the claimed steps and required a combination of some but not all
components from each protocol to arrive at the claimed five steps associated
with the financial processing computer. Net MoneyIN, Inc. v. VeriSign, Inc.,
545 F.3d at 1371. In Daridon the deposited particles include “cells from a
homogenous cell population or they may have a range of sizes, such as cells
from blood” (Daridon, 30: ¶ 0446; Ans. 5). The need to consult a different
section in Daridon pertains to choosing the type of analysis to perform on
the isolated and repositioned particle (Ans. 5). Because the microfluidic
device in context of example 5 provides for the isolation and repositioning
of single particles, such as a cell, we find that is was reasonable for the
Examiner to consult other sections of Daridon to enquire about the types of
single cell assays that can be used with the system. Daridon provides a list
of the different types of single cell analysis assays (FF 3). The list provides
five different assays, thus, this list is not so extensive that one of ordinary
skill could not envision all the members. Eli Lilly & Co. v. Zenith Goldline
Pharm., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006). The question is whether
the number of assay choices in the list (FF 3) is so large that choosing the
single cell PCR in the context of the microfluidic device would not be
immediately apparent to one of ordinary skill in the art. Wm. Wrigley Jr.
Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1361 (Fed. Cir. 2012)
citing Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir.
2005) (distinguishing cases in which a prior art reference discloses a genus
Appeal 2012-003105
Application 10/579,137

8
from those in which it discloses a number of species as part of a list). We
agree with the Examiner’s finding that selecting a nucleic acid analysis step,
such as PCR from the short list of single cell assays (FF 3), in the method set
out in Daridon (FF 2) is readily apparent to the ordinary artisan and thereby
anticipates claim 18.
Appellants contend that Daridon fails to disclose a nuclei acid
amplification on a reverse flush flow without purification (App. Br. 5).
“This affirmative ‘no purification’ requirement is nowhere disclosed in
Daridon.” (Id. at 6.)
We are not persuaded. We agree with the Examiner’s position that
“[o]ne cannot assume that purification must occur simply because it is not
specifically mentioned that it should be avoided” (Ans. 8). Daridon is silent
with regard to performing any purification steps after relocating the particle
to the analysis site. Daridon includes single cell PCR assays (FF 3) in the
list of possible assays for the analysis site (FF 2). An artisan is presumed to
know something about the art apart from what is disclosed in the reference.
See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). Here, the artisan would
know that single cell PCR assays do not generally require further
purification once the cell is isolated. Thus, the Examiner has met the burden
of demonstrating that Daridon meets the “without any purification”
limitation as it pertains to the flush flow material. Appellants have not
provided sufficient persuasive evidence to show that purification is always
necessary for nucleic acid amplifications.
We conclude that the preponderance of the evidence of record
supports the Examiner’s finding that Daridon anticipates claim 18. As
Appeal 2012-003105
Application 10/579,137

9
Appellants do not argue the claims separately, claims 19 and 21-30 fall with
claim 18. 37 C.F.R. § 41.37 (c)(1)(vii).

SUMMARY
The rejection claims 18, 19, and 21-30 under 35 U.S.C. § 102(e) over
Daridon is affirmed.

TIME PERIOD FOR RESPONSE
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

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