Ex Parte Cases et al

Board of Patent Appeals and Interferences

Jul 21, 2010

10446441 (B.P.A.I. Jul. 21, 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.
10/446,441 05/27/2003 Sylvaine Cases GLAD-240DIV 9283
24353 7590 07/21/2010
BOZICEVIC, FIELD & FRANCIS LLP
1900 UNIVERSITY AVENUE
SUITE 200
EAST PALO ALTO, CA 94303
EXAMINER
HUTSON, RICHARD G
ART UNIT PAPER NUMBER
1652
MAIL DATE DELIVERY MODE
07/21/2010 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 SYLVAINE CASES, ROBERT FARESE,
SCOT J. STONE, and PING ZHOU

__________

Appeal 2010-000188
Application 10/446,441
Technology Center 1600
__________

Before ERIC GRIMES, TONI R. SCHEINER, and LORA M. GREEN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the

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 2010-000188
Application 10/446,441

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Examiner’s rejection of claims 31-35. We have jurisdiction under 35
U.S.C. § 6(b).

STATEMENT OF THE CASE
Claims 31 and 34 are the independent claims on appeal, and read as
follows:
31. A method of screening for an inhibitor of the diacylglycerol O-
acyltransferase (DGAT) activity of a diacylglycerol acyltransferase-2α
(DGAT2α) protein, said method comprising:
a) contacting isolated DGAT2α with a test agent, wherein the
DGAT2α protein comprises an amino acid sequence having at least about
98% identity to the amino acid sequence set forth in SEQ ID NO:2; and
b) measuring DGAT activity of the DGAT2α polypeptide, wherein an
agent that reduces the DGAT activity of the DTAG2α polypeptide is a
DGAT2α inhibitor.

34. A method for inhibiting the diacylglycerol O-acyltransferase
activity of a diacylglycerol acyltransferase-2α (DGAT2α) protein, said
method comprising:
a) measuring diacylglycerol acyltransferase activity of said DGAT2α
protein; and
b) contacting said DGAT2α protein with an antibody that inhibits the
diacylglycerol O-acyltransferase activity of said DGAT2α protein, wherein
the DGAT2α protein comprises an amino acid sequence having at least
about 98% identity to the amino acid sequence set forth in SEQ ID NO:2.

I. Claims 34 and 35 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to meet the written description requirement.
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II. Claims 31-33 stand rejected under 35 U.S.C. § 102(a) as being
anticipated by Zhu2 as evidenced by Ganji.3 (Ans. 3.)
We reverse rejection I, but affirm rejection II.

ISSUE (Written Description)
Has the Examiner established by a preponderance of the evidence that
the Specification fails to provide written description support for the method
of claims 34 and 35?

FINDINGS OF FACT
FF1 The Examiner’s statement of the rejection may be found at pages 8-10
of the Examiner’s Answer.
FF2 Specifically, the Examiner notes that the claims are “directed to all
possible methods for inhibiting the diacylglycerol O-acyltransferase activity
of a diacylglycerol acyltransferase-2α (DGAT2α) protein.” (Ans. 8.)
FF3 The Examiner notes further that the Specification “does not describe
an actual reduction to practice of a method of inhibiting the DGAT activity
of a DGAT2α protein with an antibody or any other molecule,” and also
“does not describe any correlation between the sequence and the structure of
any compounds that would inhibit the DGAT activity of a DGAT2α
protein.” (Id. at 9.)

2 Zhu et al., Niacin Inhibits Activity of Diacyglycerol Acyltransferase
(DGAT), 48 JOURNAL OF INVESTIGATIVE MEDICINE 206A, Abstract 149
(2000).
3 Ganji et al., Niacin noncompetitively inhibits DGAT2 but not DGAT1
activity in HEPG2 cells, 45 JOURNAL OF LIPID RESEARCH 1835-1845 (2004).
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PRINCIPLES OF LAW
“The burden of showing that the claimed invention is not described in
the application rests on the PTO in the first instance.” In re Edwards, 568
F.2d 1349, 1354 (CCPA 1978). To comply with the written description
requirement, the Specification must “convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, [the inventor] was in
possession of the invention.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555,
1563-64 (Fed. Cir. 1991). “[T]he determination of what is needed to support
generic claims to biological subject matter depends on a variety of factors,
such as the existing knowledge in the particular field, the extent and content
of the prior art, the maturity of the science or technology, the predictability
of the aspect at issue, and other considerations appropriate to the subject
matter.” Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
For antibody claims, which are defined by their function rather than
the structure of the antibody per se, the Court of Appeals for the Federal
Circuit, our reviewing court, has adopted the USPTO Written Description
Guidelines:
[A]s persuasive authority for the proposition that a claim
directed to “any antibody which is capable of binding to antigen
X” would have sufficient support in a written description that
disclosed “fully characterized antigens.” Synopsis of
Application of Written Description Guidelines, at 60, available
at http://www.uspto.gov.web.menu.written.pdf (last visited Jan.
16, 2003) (emphasis added).

Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004); see also Enzo
Biochem Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002).
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Therefore, “as long as an applicant has disclosed a ‘fully characterized
antigen,’ either by its structure, formula, chemical name, or physical
properties, or by depositing the protein in a public depository, the applicant
can then claim an antibody by its binding to that described antigen.” Noelle,
355 F.3d at 1349.

ANALYSIS
Appellants argue that claims 34 and 35 are in compliance with the
written description requirement, as the Specification provides the sequence
of the DGAT2α protein, and methods of producing and purifying it. (Reply
Br. 8.) Appellants argue further that the claims are limited to inhibiting the
diacylglycerol O-acyltransferase activity of a diacylglycerol acyltransferase-
2α (DGAT2α) protein through use of an antibody, and that description of the
antigen is sufficient to describe the antibody whether the antibody has been
reduced to practice or not.
We agree with Appellants. That is, as Appellants have described the
antigen, they have provided adequate descriptive support for the antibody to
the antigen. Thus, we reverse the written description requirement.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the Specification fails to provide written
description support for the method of claims 34 and 35.
We thus reverse the rejection of claims 34 and 35 under 35 U.S.C.
§ 112, first paragraph, as failing to meet the written description requirement.
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ISSUE (Anticipation)
Has the Examiner established by a preponderance of the evidence that
Zhu anticipates the method of independent claim 31?

FINDINGS OF FACT
FF4 We adopt the Examiner’s findings of fact as our own. (Ans. 4-5.)
FF5 The Examiner also notes that the microsomal fractions of Zhu “are
isolated and thus any portion of the microsomal fraction including proteins
within the fraction are ‘isolated.’” (Id. at 12.)

PRINCIPLES OF LAW
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the Specification as it
would be interpreted by one of ordinary skill in the art. In re American
Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“An essential purpose of patent examination is to fashion claims that are
precise, clear, correct, and unambiguous. Only in this way can uncertainties
of claim scope be removed, as much as possible, during the administrative
process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). Moreover, it is
during prosecution that applicants have “the opportunity to amend the claims
to obtain more precise claim coverage.” American Academy, 367 F.3d at
1364.
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
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inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Inherent
anticipation does not require intent or recognition that a prior art process
achieve a result which is claimed. “Inherency is not necessarily coterminous
with the knowledge of those of ordinary skill in the art. Artisans of ordinary
skill may not recognize the inherent characteristics or functioning of the
prior art.” MEHL/Biophile Intern. Corp. v. Milgraum, 192 F.3d 1362, 1365
(Fed. Cir. 1999). In addition, “when the PTO shows sound basis for
believing that the products of the applicant and the prior art are the same, the
applicant has the burden of showing that they are not.” In re Spada, 911
F.2d 705, 708 (Fed. Cir. 1990).

ANALYSIS
Appellants argue that Zhu does not meet the limitation of contacting
“isolated DGAT2α” with a test agent, “but merely states that the effect of
niacin on DGAT activity of a microsomal fraction from HEPG2 cells was
assessed.” (Reply Br. 6.)
Appellants’ argument is not convincing. Zhu teaches that the DGAT
activity of microsmal fractions isolated from HepG2 cells was inhibited by
niacin. (See Ans. 4-5.) Giving “isolated” its broadest reasonable
interpretation, we conclude that it reads on DGAT2α that has been isolated
in some way from its natural source, and thus reads on the microsmal
fractions isolated from HepG2 cells as taught by Zhu.
Appellants argue further that while Zhu refers to DGAT and DGAT
activity, Zhu never refers to DGAT2α or DGAT2α activity. (Reply Br. 5.)
According to Appellants, “[b]ased on the disclosure provided by Zhu, it
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cannot be determined whether niacin acts on DGAT1, DGAT2α, or some
unidentified protein to effect the reported reduction in DGAT activity.” (Id.
at 6.) Appellants assert further that Ganji only provides the possibility that
Zhu could have been measuring DGAT2α, whereas the extrinsic evidence
“must make clear that the missing descriptive matter is necessarily present
in the thing described in the reference.” (Id.)
Specifically, Appellants assert:
Ganji reports that when DGAT activity was measured in
HepG2 microsomal fractions in the presence of 8 mM MgCl2,
niacin in a concentration range of from 1 mM to 3 mM
inhibited “DGAT” activity from 40% to about 44%, with a
maximum inhibition of about 50%. Ganji, Figure 1; and page
1838, bridging paragraph, columns 1 and 2.
In contrast, Zhu reports inhibition of only 10% or 12%
when HepG2 microsomal fractions were contacted with 2 mM
or 3 mM niacin. Thus, it is unclear exactly what effect Zhu was
measuring.

(Reply Br. 7.) Appellants thus argue that given the discrepancies between
the teachings of Zhu and Ganji, “it is unclear whether the effects reported in
Zhu were due to an effect on DGAT1, DGAT2α, or some unidentified
protein,” and thus “it cannot be reasonably argued that Zhu ‘inherently’
inhibited DGAT2 activity.” (Id.)
Appellants’ arguments are again not convincing. Zhu looked at the
effect of niacin on HepG2 microsomal fractions, and noted that “niacin, at
concentrations of 2mM and 3mM, significantly inhibited DGAT activity by
10% and 12%, respectively,” and that pretreatment with niacin lowered
DGAT activity 13-16%. (Zhu Abstract.) Ganji also prepared microsomes
from HepG2 cells. (Ganji, p. 1836, col. 2.) Ganji looked at the effect of
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niacin on the activity of DGAT1 and DGAT2 (i.e., DGAT2α). Ganji found
that niacin selectively inhibited DGAT2, but did not inhibit the activity of
DGAT1. (Ganji, Abstract.)
Thus, Zhu and Ganji used the same cell type in preparing the
microsomal fractions, and Ganji teaches that the fraction contains both
DGAT1 and DGAT2 (i.e., DGAT2α). Ganji teaches further that niacin
inhibits DGAT2, but not DGAT1. Thus, as Zhu found some inhibition of
DGAT activity, the ordinary artisan would reasonably expect that some
DGAT2 was present in the microsomal fraction of Zhu. Moreover, while
Zhu may not have obtained the same levels of inhibition as Ganji, the
ordinary artisan would understand that may be an artifact in any differences
between the source of the HepG2 cells and how the microsomal fractions
were prepared.

CONCLUSIONS OF LAW
We find that the Examiner has established by a preponderance of the
evidence that Zhu anticipates the method of independent claim 31.
We thus affirm the rejection of claims 31-33 under 35 U.S.C. § 102(a)
as being anticipated by Zhu as evidenced by Ganji.

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)(1)(iv)(2006).

AFFIRMED-IN-PART
Appeal 2010-000188
Application 10/446,441

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