Ex Parte BROCKHAUS et al

Board of Patent Appeals and Interferences

Nov 22, 2010

08444790 (B.P.A.I. Nov. 22, 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.
08/444,790 05/19/1995 MANFRED BROCKHAUS 9189 5612
37500 7590 11/22/2010
AMGEN INC.
LAW DEPARTMENT
1201 AMGEN COURT WEST
SEATTLE, WA 98119
EXAMINER
HOWARD, ZACHARY C
ART UNIT PAPER NUMBER
1646
MAIL DATE DELIVERY MODE
11/22/2010 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 MANFRED BROCKHAUS, ZLATKO DEMBIC,
REINER GENTZ, WERNER LESSLAUER, HANSRUEDI LOTSCHER,
and ERNST-JURGEN SCHLAEGER
__________

Appeal 2009-014889
Application 08/444,790
Technology Center 1600
__________

Before CAROL A. SPIEGEL, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL1

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 2009-014889
Application 08/444,790

2
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for failing to comply with the written description requirement and
as obvious over the applied prior art. We have jurisdiction under 35 U.S.C.
§ 6(b).

STATEMENT OF CASE
The following claim is representative.
62. A protein comprising
(a) a human tumor necrosis factor (TNF)-binding soluble fragment of
an insoluble human TNF receptor, wherein the insoluble human TNF
receptor (i) specifically binds human TNF, (ii) has an apparent molecular
weight of about 75 kilodaltons on a non-reducing SDS-polyacrylamide gel,
and (iii) comprises the amino acid sequence LPAQVAFXPYAPEPGSTC
(SEQ ID NO: 10); and
(b) all of the domains of the constant region of a human
immunoglobulin IgG heavy chain other than the first domain of said
constant region;
wherein said protein specifically binds human TNF.

Cited References

Smith et al. US 5,395,760 Mar. 7, 1995
Capon et al. US 5,116,964 May 26, 1992

Smith et al., A Receptor for Tumor Necrosis Factor Defines an Unusual
Family of Cellular and Viral Proteins, 248 SCIENCE 1019-1023 (1990).

Dembic et al., Two Human TNF Receptors Have Similar Extracellular, but
Distinct Intracellular, Domain Sequences, 2 CYTOKINE 231-237 (1990).

Appeal 2009-014889
Application 08/444,790

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Chan et al., A Domain in TNF Receptors That Mediates Ligand-Independent
Receptor Assembly and Signaling, 288 SCIENCE 2351-2354 (2000).

Grounds of Rejection
1. Claims 62, 102, 103, 105-107, 110, 111, 113, 114, 119-121 and 123-137
are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with
the written description requirement.
2. Claims 62, 102, 103, 105-107, 110, 111, 113, 114, 119-121, 125-131 and
134-137 are rejected under 35 U.S.C. § 103(a) as being unpatentable over
Dembic et al. in view of Capon et al.
3. Claims 140-144 are rejected under 35 U.S.C. § 112, first paragraph, as
introducing new matter.

Discussion
1. Claims 62, 102, 103, 105-107, 110, 111, 113, 114, 119-121 and 123-137
are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with
the written description requirement.

ISSUE
The Examiner concludes that the claims encompass a genus of soluble
TNF which is not supported by a sufficient representative number of species.
(Ans. 17.)
Appellants argue that the claims encompass soluble TNF binding
fusion proteins and that when the claims are read in view of the state of the
art the disclosure supports the scope of proteins claimed.
The issue is: Does the written description support the pending claims'
scope?
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Application 08/444,790

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PRINCIPLES OF LAW
The “written description” requirement . . . serves both to satisfy
the inventor’s obligation to disclose the technologic knowledge
upon which the patent is based, and to demonstrate that the
patentee was in possession of the invention that is claimed. . . .
The descriptive text needed to meet these requirements
varies with the nature and scope of the invention at issue, and
with the scientific and technologic knowledge already in
existence.

Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005).
Precedent illustrates that the 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.

Id. at 1359.
Where “accessible literature sources clearly provided, as of the
relevant date, genes and their nucleotide sequences . . . , satisfaction of the
written description requirement does not require either the recitation or
incorporation by reference (where permitted) of such genes and sequences.”
Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006)
(footnote omitted).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
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Application 08/444,790

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Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
The deposit requirement doesn't need to be satisfied as of filing date.
In re Lundak, 773 F.2d 1216 (Fed. Cir. 1985).

ANALYSIS
Appellants argue that “the Examiner’s requirement that the
specification reiterate sequences known in the prior art is contrary to
controlling precedent in factually parallel cases.” (App. Br. 16.) Appellants
put forth the Declaration of Lyman2 in support of the position that the
complete gene sequence of the 75Kd TNF binding peptide was known in the
art at the time of filing of the instant Specification. Appellants argue that the
claims encompass soluble TNF binding fusion proteins and that when the
claims are read in view of the state of the art the disclosure supports the
scope of the proteins claimed.
We agree with Appellants that the record supports the fact that the art
was aware of the entire gene sequence of the 75Kd TNF binding peptide.
Thus, when the written description is read in view of the state of the art, we
find that the written description supports the pending claim scope.

2 Declaration of Stewart Lyman, Ph.D, submitted August 6, 2007.
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CONCLUSION OF LAW
The written description supports the pending claim scope and thus the
written description rejection is reversed.

2. Claims 62, 102, 103, 105-107, 110, 111, 113, 114, 119-121, 125-131 and
134- 137 are rejected under 35 U.S.C. § 103(a) as being unpatentable over
Dembic et al in view of Capon et al.

ISSUE
The Examiner argues that
It would have been obvious to the person of ordinary skill in the
art at the time the invention was made to fuse the extracellular
portion of the 75 kD human TNF receptor sequence taught by
Dembic to the Fc region taught by Capon, and to recombinantly
produce the protein in CHO cells and purify the protein
produced as taught by Capon. The person of ordinary skill in
the art would be motivated to do so in order to produce and
purify the TNF receptor-1g fusion for use in affinity
purification of the TNF ligand. The person of ordinary skill in
the art would have expected success because Capon teaches that
lg fusions can be made with a wide variety of proteins, and
teaches all of the techniques for recombinant production of
hybrid immunoglobulins in CHO cells and purification of the
produced protein.

(Ans. 19-20.)
Appellants contend that “the rejection should be reversed because
the Examiner’s refusal to evaluate Appellants’ overwhelming evidence of
unexpected results is contrary to controlling case law and Appellants’
evidence of unexpected results rebuts any possible case of obviousness.”
(App. Br. 39.)
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The issue: Is Appellants’ evidence of unexpected results convincing
to rebut the Examiner’s obviousness rejection?
ANALYSIS
The Examiner took the position that Appellants’ unexpected results
appear to be generated using a fusion protein comprising a full length
extracellular domain of the insoluble 75 kD TNF binding receptor and
portions of an immunoglobulin molecule, however the specification does not
provide a written description of this species of fusion protein. (Ans. 61.)
The Examiner, further, does not dispute Appellants’ unexpected results
related to drastically reduced effector function observed for the claimed
fusion protein. Id. at 63. The claimed fusion protein additionally had
excellent binding activity, unexpectedly high kinetic stability, and improved
inhibition of the effect of TNF in biological cell culture tests. (Declaration
of Lesslauer, Exhibit B.)
We have concluded herein that the written description does support a
fusion protein comprising a full length extracellular domain of the insoluble
75 kD TNF binding receptor. This fact, taken with the fact that the
Examiner does not dispute Appellants’ unexpected results, supports a
conclusion of nonobviousness.
CONCLUSION OF LAW
Appellants’ evidence of unexpected results is convincing to rebut the
Examiner’s obviousness rejection. The obviousness rejection is reversed.

3. Claims 140-144 are rejected under 35 U.S.C. § 112, first paragraph, for
new matter.
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The Examiner finds that Appellants’ amendment to the Specification
concerning the deposit with the ATCC to be new matter. (Ans. 20-21.)
Appellants argue that the law requires that the description of a deposit
must be sufficient to permit verification that the deposited biological
material is in fact that disclosed. (App. Br. 63.)
It is well settled that the deposit requirement doesn't need to be
satisfied as of filing date. In re Lundak, 773 F.2d 1216 (Fed. Cir. 1985).
Appellants amended the Specification on November 14, 2006 to deposit the
insoluble and soluble fragments of TNF binding proteins having an apparent
molecular weight of 65.75 kD originally described in the Specification.
(App. Br. 63.) Appellants put forth the Declaration of Lesslauer3 as
evidence that a person of ordinary skill in the art would recognize that the
Specification as filed permits verification that the deposited biological
material is in fact that disclosed. (Id.) We are persuaded by Appellants’
argument.
The Examiner further argues that the deposited material contains more
sequence, such as the signal sequence, than that displayed in Fig. 4. (Ans.
73.) Appellants respond by arguing that the signal sequence is not part of
the soluble fragment encoded by the deposited construct and that the claims
exclude the signal sequence. (App. Br. 64.) Again we are persuaded by
Appellants’ argument.
The new matter rejection of claims 140-144 is reversed.

REVERSED

3 Third Declaration of Dr. Werner Lesslauer, submitted Nov. 9, 2006.
Appeal 2009-014889
Application 08/444,790

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cdc

AMGEN INC.
LAW DEPARTMENT
1201 AMGEN COURT WEST
SEATTLE, WA 98119