Ex Parte BEHR et al

Board of Patent Appeals and Interferences

Sep 18, 2006

09200791 (B.P.A.I. Sep. 18, 2006)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THOMAS M. BEHR and
DAVID M. GOLDENBERG
__________

Appeal No. 2006-2417
Application No. 09/200,791
__________

ON BRIEF
__________

Before SCHEINER, ADAMS, and GREEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on the appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 1-9, 11-21, 23-29, and 31-41, which are all
the claims pending in the application.
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below:
1. A method of reducing kidney retention of a protein conjugate in a patient,
comprising administering to said patient one or more compounds selected
from the group consisting of D-lysine, poly-lysine having a molecular
weight in the range 1-60 kD, pharmaceutically acceptable salts thereof
and carboxyl derivatives thereof, wherein said protein conjugate has a
molecular weight that is not greater than about 60 kD
wherein the pharmaceutically acceptable salt and carboxyl derivative of
polylysine has a molecular weight in the range 1-60 kD,
whereby said compound or compounds reduce kidney retention of said
conjugates.

Appeal No. 2006-2417 Page 2
Application No. 09/200,791

The references relied upon by the examiner are:
Grey et al. (Grey) 5,380,513 Jan. 10, 1995
Raines et al. (Raines) 5,840,296 Nov. 24, 1998
(filed Oct. 15, 1997)

Behr et al. (Behr), “Reduction of the Renal Uptake of Radiolabeled Monoclonal
Antibody Fragments by Cationic Amino Acids and Their Derivatives,” Cancer
Research, Vol. 55, pp. 3825-3834 (1995)

GROUNDS OF REJECTION
Claims 1-8, 11-19, 23-28, 31-39, and 41 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Behr.
Claims 1-9, 11-21, 23-29, and 31-41 stand rejected under 35 U.S.C.
§ 103 as being unpatentable over the combination of Behr, Grey, and Raines.
We affirm.

CLAIM GROUPING
Appellants do not separately group or argue the claims on appeal.
Accordingly, the claims will stand or fall together. Since all claims stand or fall
together, we limit our discussion to representative independent claim 1.
Therefore with regard to the anticipation rejection, claims 2-8, 11-19, 23-28,
31-39, and 41 will stand or fall together with claim 1. With regard to the
obviousness rejection, claims 2-9, 11-21, 23-29, and 31-41 will stand or fall
together with claim 1. In re Young, 927 F.2d 588, 590, 18 USPQ2d 1089, 1091
(Fed. Cir. 1991).

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Application No. 09/200,791
DISCUSSION
The application before us on appeal is a continuation-in-part of Application
No. 08/407,899 which has a filing date of March 21, 1995, and issued on
December 1, 1998 as United Stated Patent No. 5,843,894 (‘894). As the
examiner explains (Answer, page 9), the subject matter disclosed and claimed in
the ‘894 patent is limited to a method of reducing kidney retention of antibody
and antibody fragments. See e.g., ‘894, claim 1. In contrast, claim 1 before us
on appeal is directed to a method of reducing kidney retention of a protein
conjugate. According to the examiner (id.), the antibody or antibody fragment
conjugates disclosed in the ‘894 patent are species of the protein conjugate
genus set forth in claim 1 of the instant application. In this regard, the examiner
asserts (Answer, bridging sentence, pages 8-9), the species of the ‘894 patent
are insufficient to support the protein conjugate genus now on appeal.
Therefore, the examiner denied appellants’ claim of priority to the ‘894 patent.
Having denied appellants priority claim, the examiner applied the Behr and
Raines references which are available as prior art between the filing date of the
instant application and the ‘894.1
The rejections of record involve the Behr reference, which published
September 1, 1995 (see Brief, page 5). Therefore, Behr is available as prior art
under 35 U.S.C. § 102(b). It is undisputed on this record that Behr teaches a
species within the scope of claim 1 before us on appeal. See e.g. Answer,

1 The only other reference relied upon, Grey issued prior to the effective filing date of appellants
‘894 patent.

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Application No. 09/200,791
page 4. It is axiomatic that the disclosure of a species in a reference is sufficient
to prevent a later applicant from obtaining generic claims. In re Gosteli,
872 F.2d 1008, 1010, 10 USPQ2d 1614, 1616 Fed.Cir.1989) (holding that earlier
species invention anticipates later generic claim). Therefore, it would seem clear
that rejections of record turn on our findings as to whether appellants are entitled
to benefit from their claim of priority to the ‘894 patent. As appellants explain it
(Reply Brief, page 2),
[a]ppellants and the [e]xaminer are in agreement that a
major issue in this Appeal is whether or not the instant claims are
entitled to the March 21, 1995 priority date of . . . [the ‘894 patent].
A central issue of contention between the [e]xaminer and
[a]ppellants is whether or not there is sufficient written description
support in the . . . [‘894 patent] to justify a March 21, 1995 priority
date for the instant claims.

Accordingly, as we understand the record, the examiner and appellants agree
that the only way appellants can overcome the examiner's rejections under
35 U.S.C. § 102(b) and § 103 is to remove Behr as prior art. On this record, the
only way appellants can remove the Behr reference is by obtaining the benefit of
the filing date of the ‘894 patent. Accordingly, the dispositive issue before us is
one of priority.

Priority:
We begin by noting that claims found in a later-filed application are entitled
to the filing date of an earlier application if, inter alia, the disclosure in
the earlier application provides an adequate written description of the later-filed
claims under 35 U.S.C. § 112, first paragraph. See Tronzo v. Biomet, Inc.,

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Application No. 09/200,791
156 F.3d 1154, 1158, 47 USPQ2d 1829, 1832 (Fed. Cir. 1998) (discussing
requirements of claiming benefit of priority date of earlier application under
35 U.S.C. § 120).
As appellants point out (Brief, page 6), this requires the disclosure in the
earlier application to reasonably convey to one of ordinary skill in the art that the
inventors possessed the later-claimed subject matter when they filed the earlier
application. See e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473,
1479, 45 USPQ2d 1498, 1502-1503 (Fed. Cir. 1998); Univ. of Cal. v. Eli Lilly and
Co., 119 F.3d 1559, 1567, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997)2. Upon
consideration of the ‘894 patent, we find that ‘894 discloses (column 1, lines 4-7),
“[t]his invention relates to a method for reducing renal uptake of monoclonal
antibody fragments used for radioimmunodiagnosis (RAID), immunotherapy, and
radioimmunotherapy (RAIT).” ‘894 further discloses (column 1, lines 16-18), “[a]
major drawback to the use of radiolabeled antibody fragments for imaging and
therapy is the relatively high uptake and retention of radioactivity in the kidney.”
We note that this section of the ‘894 patent does not speak to proteins generally,
but instead is very specifically drawn to radiolabeled antibody fragments.

Regarding proteins generally, we find as appellants point out (Brief,

2 We recognize that appellants’ Reply Brief makes reference to these cases as well. Reply Brief,
pages 3-4.

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Application No. 09/200,791
page 7) that the ‘894 patent discusses proteins is at column 1, lines 33-50. While
it is true that the ‘894 patent briefly discusses proteins as part of the background
section of the ‘894 disclosure, the ‘894 patent discloses
[column 1, lines 39-63] that current methodology for decreasing kidney uptake of
radiolabeled peptides requires either “continuous infusion” or “repeated injection,”
both of which “cause substantial inconvenience and increased costs in a clinical
setting. In addition, the most clinically efficacious dosages of amino acids
approach the maximum levels that can be physiologically tolerated before toxicity
is observed.” Therefore, the ‘894 patent discloses (column 1, lines 65-67,
emphasis added), “[i]t is therefore an object of the present invention to provide
methods that greatly reduce kidney uptake of antibody fragment conjugates.”
The remainder of the patent discusses antibody fragment conjugates. We find
no disclosure in the ‘894 patent that would suggest that its methodology would be
useful for all protein conjugates as is now claimed. For their part, other than
citing the first column of the ‘894 patent, appellants fail to direct our attention to
any other portion of the ‘894 patent that would suggest or describe the
applicability of the disclosed methodology for non-antibody conjugates.
We also recognize appellants’ argument (Brief, page 3) that the facts in
this case are different than those in Lilly. According to appellants (Reply Brief,
page 3), “[i]n the present case, no nucleic acid or protein sequences are part of
the claimed subject matter. Rather, the claims recite protein conjugates of ‘not
greater than about 60 kD.’ This is a simple physical property of the protein
conjugate, that is not dependent upon the amino acid sequence of the protein or

Appeal No. 2006-2417 Page 7
Application No. 09/200,791
encoding nucleic acids.” Accordingly, appellants assert (id.), cases such as Lilly
and Amgen Inc. v. Chugai Pharmaceutical Co., Ltd. 927 F.2d 1200, 18 USPQ2d
1016 (Fed. Cir. 1991) “are not valid precedent for the written description question
addressed herein.” We disagree.
While the subject matter in Lilly was directed to genetic material, the
requirements of the statute applies to all types of invention. See Univ. of
Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 925, 69 USPQ2d 1886, 1893
(Fed. Cir. 2004) (“Regardless whether a compound is claimed per se or a
method is claimed that entails the use of the compound, the inventor cannot lay
claim to that subject matter unless he can provide a description of the compound
sufficient to distinguish infringing compounds from non-infringing compounds, or
infringing methods from non-infringing methods.”)
Whether or not an application adequately describes a claimed invention is
determined as of the application’s filing date. See Hyatt v. Boone, 146 F.3d
1348, 1354, 47 USPQ2d 1128, 1132 (Fed. Cir. 1998) (“[T]he purpose of the
description requirement is ‘to ensure that the inventor had possession, as of the
filing date of the application relied on, of the specific subject matter later claimed
by him.’”) For the reasons set forth above, we find our that the facts on this
record weigh in favor of the examiner – the antibody species disclosed in the
‘894 patent do not support the broader genus of any protein conjugate. As
discussed above, there is simply no disclosure in the ‘894 patent to suggest the
applicability of the disclosed methodology to anything other than antibody
conjugates or for use in any other application other than radioimmuno-therapy or

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Application No. 09/200,791
diagnostics. See e.g., the ‘894 patent, column 2, lines 1-17, where the patent
discloses “[i]n accomplishing, the foregoing object of the invention, there has
been provided . . . a method of reducing kidney uptake of antibody fragment
conjugates in a patient during radioimmunodiagnosis or immunotherapy. . . .”
There is no disclosure in the ‘894 patent that the disclosed methodology would
be generally applicable to any protein conjugate.
For the foregoing reasons, it is our opinion that the ‘894 patent does not
provide a description of the genus of protein conjugates set forth in the claims
now before us on appeal. Accordingly, it is our opinion that the claims before us
on appeal are not receive the benefit of the filing date of the ‘894 patent.

Anticipation:
For the foregoing reasons, we find no error in the rejection of claim 1
under 35 U.S.C. § 102(b) as anticipated by Behr. Therefore, the rejection is
affirmed. As set forth above claims 2-8, 11-19, 23-28, 31-39, and 41 fall together
with claim 1.

Obviousness:
Having found claim 1 anticipated by Behr, we find no error in the
obviousness rejection of claim 1, for obviousness is the epitome of anticipation.
Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 716, 223 USPQ

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Application No. 09/200,791
1264, 1271 (Fed. Cir. 1984) (“a disclosure that anticipates under § 102 also
renders the claim invalid under § 103, for ‘anticipation is the epitome of
obviousness,’ In re Fracalossi, 681 F.2d 792, 215 USPQ 569 (CCPA 1982).”).
Therefore, the rejection is affirmed. As set forth above claims 2-9, 11-21, 23-29,
and 31-41 fall together with claim 1.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 CFR § 1.136(a).

AFFIRMED

Toni R. Scheiner )
Administrative Patent Judge )
)
) BOARD OF PATENT
)
Donald E. Adams ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
Lora M. Green )
Administrative Patent Judge )

DA/dym

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Application No. 09/200,791
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