Ex Parte Hsueh et al

Board of Patent Appeals and Interferences

Nov 1, 2010

10851470 (B.P.A.I. Nov. 1, 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.
10/851,470 05/21/2004 Aaron J.W. Hsueh STAN-084CON 8719
77974 7590 11/01/2010
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
1900 University Avenue
Suite 200
East Palo Alto, CA 94303
EXAMINER
BUNNER, BRIDGET E
ART UNIT PAPER NUMBER
1647
MAIL DATE DELIVERY MODE
11/01/2010 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 AARON J.W. HSUEH, SHEAU YU HSU,
SHAN-GUANG LIANG, and PETRUS JOHANNES VAN DER SPEK
__________

Appeal 2010-005459
Application 10/851,470
Technology Center 1600
__________

Before ERIC GRIMES, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to an
antibody. The Examiner has rejected the claims for lack of patentable utility

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 2010-005459
Application 10/851,470

2
and nonenablement. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
STATEMENT OF THE CASE
Claims 12, 13, and 19-22 are on appeal. The claims have not been
argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 12 is representative and reads as follows:
12. An isolated antibody binding specifically to a mammalian
leucine-rich repeat-containing G protein-coupled receptor 7 (LGR7) protein,
wherein said mammalian LGR7 protein comprises an amino acid sequence
at least 90% identical to the amino acid sequence set forth in SEQ ID NO:8.

All of the claims on appeal stand rejected under 35 U.S.C. §§ 101 and
112, first paragraph, on the basis that the Specification does not disclose a
patentable utility for the claimed antibody (Answer 4, 9) and separately
under 35 U.S.C. § 112, first paragraph, on the basis that, even if the claims
are found to have patentable utility, they are not enabled throughout their
full scope (Answer 9).
Issue
The Examiner finds that “the claimed invention is not supported by
either a credible, specific and substantial asserted utility or a well established
utility” (Answer 4). The Examiner finds that the Specification asserts that
the claimed antibodies are useful “in staining or immunoassays” and “to
determine the absence or presence or altered amounts of normal or abnormal
LGR7 in patient cells” (id. at 5) but that the Specification “discloses nothing
specific or substantial for the LGR7 polypeptide” detected using the
antibodies (id. at 5-6).
Appeal 2010-005459
Application 10/851,470

3
Appellants contend that using the claimed antibodies to detect LGR7
in cells is a credible, specific, and substantial utility (Appeal Br. 6) because
“the art is replete with examples of antibodies that are used to ascertain the
presence, absence and/or level of a particular protein in a cell so as to
identify what type of cell that cell is and/or the state of that cell, wherein the
molecular function for the protein that is the target of that antibody has not
been fully elucidated” (id. at 7).
The issue presented is: Does the Specification’s disclosure allow a
skilled worker to use the claimed antibodies in a specific and substantial
way?
Findings of Fact
1. The Specification discloses that the “receptors for LH [luteinizing
hormone], FSH [follicle-stimulating hormone] and TSH [thyrotropin] belong
to the large G-protein-coupled, seven-trans-membrane protein family but are
unique in having a large N-terminal extra-cellular (ecto-) domain containing
leucine-rich repeats important for interaction with large glycoprotein
ligands” (Spec. 1: 13-16).
2. The Specification discloses three proteins referred to as LGR4,
LGR5, and LGR7, which “have trans-membrane segments and extra-cellular
regions similar to those found in the known LH, FSH, and TSH receptors.
In other words, these proteins have both a G-protein coupled seven trans-
membrane region and a leucine rich repeat extra-cellular domain.” (Id. at
3: 29 to 4: 1.)
3. The Specification discloses that “analysis of the LGR7 ORF . . .
showed that its tertiary structure resembles that of mammalian LGRs instead
Appeal 2010-005459
Application 10/851,470

4
of the snail receptor. . . . These findings suggest that LGR7 and snail
receptor diverged early during evolution and LGR7 perhaps adopted new
function in higher organisms.” (Id. at 25: 21-25.)
4. The Specification discloses that “LGR7 is expressed in multiple
tissues, including testis, ovary, prostate, intestine and colon” (id. at 4: 20-
21).
5. The Specification does not disclose the ligand that binds to the
putative LGR7 receptor.
6. The Specification does not disclose the effect that LGR7/ligand
binding has on a cell.
7. The Specification discloses that the “LGR4, LGR5, and LGR7
polypeptides are useful for the production of antibodies” (id. at 11: 12-13).
8. The Specification discloses that “[a]ntibodies specific for LGR4,
LGR5, or LGR7 proteins may be used in staining or in immunoassays” (id.
at 14: 7-8).
9. The Specification discloses that the antibodies can be used “to
determine the absence or presence or altered amounts of normal or abnormal
LGR4, LGR5, or LGR7 in patient cells” (id. at 14: 14-20).
10. The Specification does not disclose that finding the absence or
presence or altered amounts of normal or abnormal LGR7 in a patient’s cells
has any particular meaning (e.g., that it is diagnostic of a disease).
11. The present application claims priority to a provisional
application filed March 26, 1998 (Amendment filed Jan. 22, 2008, page 2).
Appeal 2010-005459
Application 10/851,470

5
Principles of Law
The courts “have required a claimed invention to have a specific and
substantial utility to satisfy § 101.” In re Fisher, 421 F.3d 1365, 1371 (Fed.
Cir. 2005).
“[A]n application must show that an invention is useful to the public
as disclosed in its current form, not that it may prove useful at some future
date after further research. Simply put, to satisfy the ‘substantial’ utility
requirement, an asserted use must show that that claimed invention has a
significant and presently available benefit to the public.” Id.
To satisfy “the ‘specific’ utility requirement, an application must
disclose a use which is not so vague as to be meaningless. . . . Thus, in
addition to providing a ‘substantial’ utility, an asserted use must show that
th[e] claimed invention can be used to provide a well-defined and particular
benefit to the public.” Id.
“It is well established that the enablement requirement of § 112
incorporates the utility requirement of § 101.” Id. at 1378.
“Enablement, or utility, is determined as of the application filing
date.” In re Brana, 51 F.3d 1560, 1567 n.19 (Fed. Cir. 1995).
“It is an applicant’s obligation to supply enabling disclosure without
reliance on what others may publish after he has filed an application on what
is supposed to be a completed invention. If he cannot supply enabling
information, he is not yet in a position to file.” In re Glass, 492 F.2d 1228,
1232 (CCPA 1974).
Appeal 2010-005459
Application 10/851,470

6
Analysis
The Specification discloses the LGR7 polypeptide, a putative
G-protein coupled receptor. The Specification also discloses that LGR7-
specific antibodies can be made, and that such antibodies can be used to
detect or quantify LGR7 in a patient’s cells. However, the Specification
does not disclose any practical significance for detecting the presence,
absence or altered amounts of normal or abnormal LGR7 in a patient’s cells.
The Specification does not, for example, disclose that the presence,
absence, or altered amount of LGR7 is associated with some disease or
abnormal condition. Nor does the Specification disclose that the presence,
absence, or altered amount of LGR7 indicates that the cell has some specific
property. Therefore, we agree with the Examiner that the Specification does
not disclose a specific and substantial utility for the claimed antibodies; i.e.,
a use that provides a “significant and presently available benefit” as well as a
“well-defined and particular benefit.” See Fisher, 421 F.3d at 1371.
Appellants argue that the claimed antibodies are useful even though
the Specification does not disclose the function of LGR7, because detection
of other proteins, such as CD antigens, is known in the art to be useful to
identify cell types or cell states even though the function of the detected
protein itself is unknown (Appeal Br. 7-8).
This argument is unpersuasive. While we agree that the Specification
need not necessarily disclose the function of LGR7 in order to provide a
patentable utility for the claimed antibodies, in this case the Specification
merely discloses that LGR7 is expressed in “multiple tissues, including
testis, ovary, prostate, intestine and colon” (FF 4). This disclosure does not
Appeal 2010-005459
Application 10/851,470

7
allow a skilled worker to identify any specific tissue type based on LGR7
expression, especially since the Specification’s disclosure of “multiple
tissues, including” those listed does not exclude any other tissue types. We
do not agree that those skilled in the art would recognize this disclosure as
providing a “significant and presently available benefit” as well as a “well-
defined and particular benefit.” See Fisher, 421 F.3d at 1371.
Appellants also rely on several references that were published after
the effective filing date of the present application as evidence that the
claimed antibodies have utility (Appeal Br. 7-8).
We have considered Appellants’ post-filing references to the extent
that they confirm the accuracy of statements in the Specification. Post-filing
evidence can be used to show the accuracy of a statement in the
Specification, but not to “render an insufficient disclosure enabling.” Brana,
51 F.3d at 1567 n.19. Thus, Appellants can rely on the post-filing references
only to show that the Specification accurately stated that SEQ ID NO: 8 is a
G-protein coupled receptor, not to supplement the utilities disclosed in the
Specification.
Because we find that the Specification does not disclose a utility for
the claimed antibodies that satisfies 35 U.S.C. § 101, we also conclude that
the Specification does not satisfy the enablement requirement of 35 U.S.C.
§ 112, first paragraph, since it therefore does not teach how to use the
claimed invention throughout its full scope. See Fisher, 421 F.3d at 1378
(“It is well established that the enablement requirement of § 112
incorporates the utility requirement of § 101.”).
Appeal 2010-005459
Application 10/851,470

8
Conclusion of Law
The Specification’s disclosure does not allow a skilled worker to use
the claimed antibodies in a specific and substantial way.
SUMMARY
We affirm the rejection of claims 12, 13, and 19-22 under 35 U.S.C.
§§ 101 and 112, first paragraph, for lack of patentable utility.
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

lp

STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING
BOZICEVIC, FIELD & FRANCIS LLP
1900 UNIVERSITY AVENUE
SUITE 200
EAST PALO ALTO CA 94303