Ex Parte Lo et al

Board of Patent Appeals and Interferences

Sep 9, 2010

10437500 (B.P.A.I. Sep. 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.
10/437,500 05/13/2003 Yuk Ming Dennis Lo 016285-003310US 4446
20350 7590 09/09/2010
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO, CA 94111-3834
EXAMINER
MYERS, CARLA J
ART UNIT PAPER NUMBER
1634
MAIL DATE DELIVERY MODE
09/09/2010 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 YUK MING DENNIS LO, KAI ON NG,
BO YIN TSUI, WAI KWUN ROSSA CHIU,
YUEN SHAN LISA CHAN, TIMOTHY HUDSON
RAINER, and YUK LAN LAM,

Appellants.
_________________

Appeal 2010-004847
Application 10/437,500
Technology Center 1600
_________________

Before SALLY GARDNER LANE, JAMESON LEE, and RICHARD
TORCZON, Administrative Patent Judges.

LANE, Administrative Patent Judge.
DECISION ON APPEAL1

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.
Appeal 2010-004847
Application 10/437,500

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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134, is from a Final Rejection of claims
24-26, 28, 32-34, and 39-41. Appellants canceled claims 23, 27, 30, 31, and
35-38 and withdrew claim 29. (App. Br. 3). We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
Appellants’ specification discusses the discovery that nucleic acids in
the blood plasma or serum are either “particle associated” or “non-particle
associated.” According to the specification, separating the serum or plasma
into two or more fractions separates the particle and non-particle associated
nucleic acids, allowing the relative concentrations of each to be determined
and used to evaluate diseases and conditions in a patient. (Spec. ¶ [40]).
Appellants claim a method of detecting placental mRNA in a pregnant
woman’s plasma or serum. (See App. Br. 12-13, Claims App’x).
The Examiner relied on the following articles:
• Fleishhacker et al., “Detection of Amplifiable Messenger RNA
in the Serum of Patients with Lung Cancer,” Ann. N.Y. Acad.
Sci. 179-88 (2001).
• Chiu et al., “Quantitative Analysis of Circulating Mitochondrial
DNA in Plasma,” 49 Clin. Chem. 719-26 (2003).
• El-Hefnawy et al., “Characterization of Amplifiable,
Circulating RNA in Plasma and Its Potential as a Tool for
Cancer Diagnostics,” 50 Clin. Chem. 564-73 (2004).
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Appellants appeal the rejection of claims 24-26, 28, 32-34, and 39-41
under 35 U.S.C. § 112 first and second paragraphs2, without arguing for the
separate patentability of any of these claims. We focus on claim 24 in our
review. See 37 C.F.R. § 41.37(c)(1)(vii).
II. FINDINGS OF FACT
1. Appellants’ claim 24 recites:
A method for detecting a placental derived mRNA in a
pregnant woman's plasma or serum, the method comprising the
steps of:
(i) obtaining a blood sample from the woman and taking
two aliquots from the sample;
(ii) producing a first post-filtration fraction of the plasma
or serum of the first aliquot by filtration using a 5-μm filter;
(iii) determining the mRNA concentration in the first
post-filtration fraction;
(iv) producing a second post-filtration fraction or a post-
centrifugation fraction of the plasma or serum of the second
aliquot by filtration using a filter of smaller than 5 μm or by
ultracentrifugation;
(v) determining the mRNA concentration in the second
post-filtration fraction or the post-centrifugation fraction; and
(vi) comparing the mRNA concentration in the first post-
filtration fraction and the mRNA concentration in the second
post-filtration fraction or the post-centrifugation fraction.

(App. Br. 12; Claims App’x).

2. Example 4 of Appellants’ specification provides that particle-
associated glyceraldehyde-3-phosphate dehydrogenase (GAPDH) mRNA

2 Appellants also appeal the rejection of claims 24-26, 32-34, and 39-41
under 35 U.S.C. § 103(a) (see Office Action mailed March 12, 2009, pp. 26-
33) but these rejections were withdrawn by the Examiner (Ans. 2).
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4
was present in the plasma of pregnant women and in lower concentrations
than “healthy” (which we understand to mean non-pregnant) subjects
whether the plasma was filtered or not. Similarly, there was no difference in
the concentration of beta-globin “DNA” [sic - mRNA?] concentrations with
and without filtration between pregnant and “healthy” subjects. (Spec.
¶ [99]).
3. Example 4 of Appellants’ specification provides that plasma
mRNA concentrations of human placental lactogen (hPL) and the beta-
subunit of human chorionic gonadotropin (βhCG) decreased significantly
when filtered through a 0.45 μm filter. (Spec. ¶ [101]).
4. Example 4 of Appellants’ specification provides the conclusion
that the placental derived mRNAs for hPL and βhCG are associated with
subcellular particulate matter. (Spec. ¶ [101]).
5. Appellants’ specification does not discuss the relative
differences in mRNA concentration of total mRNA or any specific,
preselected placenta derived mRNA species in a “first post-filtration fraction
of the plasma or serum of the first aliquot by filtration using a 5-μm filter”
(as in step (ii) of claim 24) and a “second post-filtration fraction or a post-
centrifugation fraction of the plasma or serum of the second aliquot by
filtration using a filter of smaller than 5 μm or by ultracentrifugation” (as in
step (iv) of claim 24).
III. ISSUES
Did the Appellants’ specification enable one skilled in the art to detect
a placental derived mRNA by comparing the mRNA concentrations of
different fractions of plasma or serum?
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IV. ANALYSIS
35 U.S.C. § 112, first paragraph
“Enablement requires that the specification teach those in the art to
make and use the invention without undue experimentation.” In re Wands,
858 F.2d 731, 737 (Fed. Cir. 1988). Factors including the amount of
guidance and nature of the working examples provided in a specification are
part of the evaluation of whether a claimed method is enabled. See id.
The Examiner rejected the claims as lacking enabling support in the
specification because the specification does not establish that a comparison
of mRNA concentration in the fractions produced by steps (ii) and (iv)
indicates the presence of placenta-derived mRNA. (Ans. 21). In addition,
the Examiner rejected the claims for lack of enabling support because the
specification does not provide sufficient guidance as to which mRNAs are
associated with particles of different sizes such that a difference in
concentration in different fractions indicates presence of placental derived
mRNAs. (Ans. 22). According to the Examiner, the examples in
Appellants’ specification do not show that placental derived mRNAs are
associated with particles of a specific size so that they will be found in one
fraction rather than another. (Ans. 13-14; see FFs 2-5). The Examiner also
cites Fleishhacker, El-Hefnawy, and Chiu as teaching that mRNA content in
serum is highly variable and unpredictable due to degrading enzymes and
differences in the results produced by different protocols. (Ans. 15-17).
Indeed, while Appellants’ specification provides Examples that
describe filtration of particle-associated mRNAs (FFs 2-4), Appellants do
not cite, and we do not find, information in Appellants’ specification that
describes how determining and comparing the concentration of mRNA in
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the fractions provided in claim 24 indicate that placental mRNA is present.
(See FF 5).
Appellants argue that the Examiner has improperly narrowed the
scope of claim 24 by reading a limitation to a diagnostic method into it.
(App. Br. 5-7). Appellants’ argument is unpersuasive since, even under a
broader construction that is not limited to diagnosing, the specification does
not teach how the step (vi) comparison required by the claim would give a
useful result.
Appellants also argue, for the first time in their Reply Brief, that the
term “the mRNA” in steps (iii), (v), and (vi) of claim 24 refer to and have
antecedent basis in “a placental derived mRNA” in the preamble. (Reply Br.
5-6). Appellants argue that the claimed method does not indicate that total
mRNA would be measured, but, instead, only a specific, preselected
placental derived mRNA species. (Id.). Appellants have not amended their
claims to make this construction clear. See In re Morris, 127 F.3d 1048,
1057 (Fed. Cir. 1997) (“The PTO was not only permitted but obligated to
reject claim 1 when appellants failed precisely to define in the written
description the disputed language, and there was a reasonable alternative
definition.”). Nor have Appellants directed us to evidence showing that
those in the art would have understood the steps recited in claim 24 to mean
only one mRNA species should be considered and have not directed us to a
portion of their specification supporting this assertion. Even were we to
adopt Appellants’ proposed claim construction, Appellants have not directed
us to a portion of their specification that explains how the comparison step
(vi) yields a useful result.
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The Examiner correctly found that Appellants’ specification fails to
enable a method for detecting a placental derived mRNA by comparing the
mRNA concentrations of different fractions of plasma or serum.
Accordingly, we conclude that claim 24 is not enabled.
35 U.S.C. § 112, second paragraph
We affirm the Examiner’s rejection of claims 24-26, 28, 32-34, and
39-41 under 35 U.S.C. § 112, first paragraph. We need not and do not
consider the propriety of the Examiner’s rejection of these same claims
under 35 U.S.C. § 112, second paragraph.
V. ORDER
Upon consideration of the record and for the reasons given, the
rejections of claims 24-26, 28, 32-34, and 39-41 under 35 U.S.C.
§ 112, first paragraph, is AFFIRMED, and
we decline to review the rejection of claims 24-26, 28, 32-34, and 39-
41 under 35 U.S.C. § 112, second paragraph.

AFFIRMED

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