Ex Parte Scholl et al

Patent Trial and Appeal Board

Dec 17, 2013

11830604 (P.T.A.B. Dec. 17, 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.
11/830,604 07/30/2007 Thomas Scholl 3002-01-1D 3106
26698 7590 12/18/2013
MYRIAD GENETICS INC.
INTELLECTUAL PROPERTY DEPARTMENT
320 WAKARA WAY
SALT LAKE CITY, UT 84108
EXAMINER
AEDER, SEAN E
ART UNIT PAPER NUMBER
1642
MAIL DATE DELIVERY MODE
12/18/2013 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 THOMAS SCHOLL, BRANT C. HENDRICKSON,
BENJAMIN WARD, and DMITRY PRUSS
__________

Appeal 2012-004077
Application 11/830,604
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
method for detecting a mutation in a BRCA1 allele. The Patent Examiner
rejected the claims as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b). We reverse.

1 Appellants identify the Real Party in Interest as Myriad Genetics, Inc. (See
App. Br. 3.)
Appeal 2012-004077
Application 11/830,604

2
STATEMENT OF THE CASE
Claims 53-60, 62, 63, and 66 are on appeal. Claim 53 is
representative and reads as follows:
53. A method for detecting a mutation in a BRCA1 allele comprising:
analyzing a nucleic acid from a sample obtained from a human subject; and
detecting a mutation in a BRCA1 allele wherein said mutation results in a
BRCA1 mRNA encoding a polypeptide comprising SEQ ID No. 85.

The Examiner rejected claims 53-60, 62, 63, and 66 under 35 U.S.C.
§102(e) as being anticipated by Allen.2

ANTICIPATION
The Examiner found that Allen taught the 24 exons of wild-type
BRCA1 along with a method of identifying and detecting the presence of
previously unknown mutations in the BRCA1 gene comprising sequencing
the entire length of the gene. (Ans. 6.) According to the Examiner, one of
skill in the art at the time of the invention would have recognized that when
sequencing a DNA molecule, such as a BRCA1 allele, mutations of the
molecule are detected. (Id.) The Examiner found that the plain meaning of
the term “‘detecting’” includes “‘determining the existence or presence of’”.
(Id. at 5.) The Examiner reasoned that “[j]ust as methods of detecting
alcohol in blood do not require the blood to comprise alcohol, the instant
method of detecting the mutation recited in Claim 53 do[es] not require the
mutation to be present in a patient sample in order to perform the act of
detecting the mutation.” (Id. at 6.) Therefore, according to the Examiner,

2 Patent Application Publication No. US 2003/0027166 A1 by Antonette
C.P. Allen et al., published Feb. 6, 2003.
Appeal 2012-004077
Application 11/830,604

3
Allen’s method of identifying the presence of previously unknown BRCA1
mutations in a sample obtained from a human subject also would detect the
presence or absence of a BRCA1 allele wherein only exons 16-17 have been
deleted (encoding instant SEQ ID NO:85). (Id.)
Appellants contend that Allen’s method does not anticipate the
claimed invention because Allen did not report detecting a mutation that
results in a polypeptide comprising SEQ ID NO:85. (App. Br. 6-7.)
Appellants assert that the term “‘detect’” means “‘to discover the existence
or presence of,’” which does not merely mean “to look for,” but rather “to
find.” (Reply Br. 5-6)(citing Spec. [093] distinguishing “‘[t]o determine the
presence or absence of’” and “to be detected”). Thus, with respect to the
claimed invention, Appellants assert that “‘[d]etecting’ implies that
something (e.g., apparatus, reagent, sensor, etc.) in Allen recognized the
presence of the mutation in Claim 53 (e.g., in a subject sample).” (App. Br.
9; see also Reply Br. 5-6.)
The issue of whether Allen supports the Examiner’s anticipation
rejection of the claimed method turns on the proper construction of the claim
term “detecting.” We note that the plain meaning of the term “detect”
includes “2: to discover or determine the existence, presence, or fact of.”3
We find that this plain meaning means “finding the existence, presence, or
fact of,” and not merely “looking for the presence or absence of.”
Therefore, the claimed method of detecting a mutation in a BRCA1 allele
resulting in a BRCA1 mRNA encoding a polypeptide comprising SEQ ID
No. 92, is a method that requires finding such a mutation. Because the

3 Merriam Webster Online Dictionary, M-W.COM, http://www.merriam-
webster.com/dictionary/detect (last visited Dec. 13, 2013).
Appeal 2012-004077
Application 11/830,604

4
Examiner has not established that Allen’s method necessarily finds the
mutation recited in the claimed method, we reverse the anticipation
rejection. See Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628,
631 (Fed. Cir. 1987).
REVERSED

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