Ex Parte Hakonarson

Board of Patent Appeals and Interferences

Apr 30, 2010

11592699 (B.P.A.I. Apr. 30, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte HAKON HAKONARSON
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Appeal 2009-012999
Application 11/592,699
Technology Center 1600
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Decided: April 30, 2010
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Before TONI R. SCHEINER, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-9, directed to a genetic expression profile. The claims have been
rejected under 35 U.S.C. § 101 as directed to non-statutory subject matter.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appeal 2009-012999
Application 11/592,699

STATEMENT OF THE CASE
The Examiner rejected claims 1-9 under 35 U.S.C. § 101 as directed
to non-statutory, patent-ineligible subject matter.
Claim 1 is representative:
1. An expression profile for predicting the responsiveness of a patient
with unknown responsiveness to a drug for the treatment of an inflammatory
disease, comprising:
a) a first expression profile comprising expression levels of gene
products from one or more genes set forth in Tables 1, 2A, 2B, 4A, 4B and
5A-5E obtained from a patient population with known responsiveness to a
drug for the treatment of an inflammatory disease; and
b) a second expression profile comprising expression levels of gene
products from the same one or more genes used in the first expression
profile, obtained from a second patient population with known non-
responsiveness to the same drug used in the first expression profile;
wherein the first and second expression levels together comprise the
expression profile for predicting the responsiveness of a patient with
unknown responsiveness to the drug used in the first and second expression
profiles.

ISSUE
Does the claimed expression profile fall within one of the statutory
classes of patent-eligible subject matter?
PRINCIPLES OF LAW
Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new
and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of the is title.

35 U.S.C. § 101.

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Appeal 2009-012999
Application 11/592,699

FINDINGS OF FACT
FF1 “[A]n ‘expression profile’ refers to the level or amount of gene
expression of one or more informative genes in a given sample of cells at
one or more time points” (Spec. 8-9).
ANALYSIS
The Examiner finds that the claims “are drawn to an ‘expression
profile’ comprising expression levels of a gene product . . . and thus relate[ ]
to numerical data . . . [which] falls under the category of nonstatutory
subject matter” (Ans. 3).
Appellant contends that “[t]he claimed invention, the expression
profile, is a specific apparatus of practical utility and not merely numerical
data” (Reply Br. 3). Appellant contends that “[a]n expression profile . . .
requires selection of certain elements, such as the drug to be screened, the
genes to study, and the conditions in which to run the profiles” (id.), and “is
useful because it is used to predict the responsiveness of a patient to a drug
for the treatment of inflammatory disease” (id. at 3-4). Appellant contends
that “[t]he data in its entirety creates novel and useful structures” (id. at 3).
Appellant’s argument is not persuasive. Patent eligibility under
section 101 requires three things: the subject matter must be novel, it must
be useful, and it must fall within one of the enumerated classes of invention.
Even if the novelty and utility of the claimed expression profiles are not at
issue here, satisfying these two prongs of the statute does not obviate the
third. “If a claim covers material not found in any of the four statutory
categories, that claim falls outside the plainly expressed scope of § 101 even
if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d
1346, 1354 (Fed. Cir. 2007).
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Appeal 2009-012999
Application 11/592,699

Despite Appellant’s characterization of the claimed invention as “a
specific apparatus of practical utility” and a “novel and useful structure[ ]”
(Reply Br. 3), Appellant has not explained how the expression profile itself -
regardless of the method in which it is obtained or used - is anything more
than a compilation of data. To the extent Appellant considers the claimed
expression profile to be a “data structure,” we disagree. The claimed
expression profile “does not imply a physical arrangement of the contents of
a memory,” nor is it even embodied in a computer readable medium. See In
re Warmerdam, 33 F.3d 1354, 1361-62 (Fed. Cir. 1994). We agree with the
Examiner that mere data, standing alone, does not fall within one of the
patent-eligible classes of invention - it is manifestly not a process - nor is it a
machine, a manufacture, or a composition of matter.
CONCLUSIONS OF LAW
The claimed expression profile does not fall within one of the
statutory classes of invention, and therefore, is not patent eligible subject
matter.
The rejection of claims 1-9 under 35 U.S.C. § 101 is affirmed.

AFFIRMED

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