Ex Parte Goldenberg et al

Patent Trial and Appeal Board

Jul 11, 2016

13178307 (P.T.A.B. Jul. 11, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/178,307 07/07/2011
37013 7590 07113/2016
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
FIRST NAMED INVENTOR
David M. GOLDENBERG
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
IMMU-0005US5 8134
EXAMINER
SCHWADRON, RONALD B
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
07/13/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
mail@rkmllp.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID M. GOLDENBERG and HANS J. HANSEN
Appeal2014-003726
Application 13/178,307
Technology Center 1600
Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for treating an autoimmune disorder. The Examiner rejected the claims as
failing to comply with the written description requirement and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as lmmunomedics,
Inc. (see App. Br. 2).
Appeal2014-003726
Application 13/178,307
Statement of the Case
Background
"[T]his invention is directed to methods for treating autoimmune
disorders by administering antibodies that bind to a B-cell antigen, such as
the CD22, CD20, CD19, and CD74 or HLA-DR antigen" (Spec. 1, 11. 14--
16).
The Claims
Claims 1, 2, 10-13, 17, and 18 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for treating an autoimmune disorder,
comprising administering to a subject having an autoimmune
disorder and having failed methotrexate therapy, a therapeutic
composition comprising a pharmaceutically acceptable carrier
and at least one human, humanized or chimeric anti-CD74
antibody which binds to human CD7 4, or an antigen-binding
fragment of said anti-CD74 antibody, or an anti-CD74 fusion
protein \vhich binds to human CD74.
The Issues
A. The Examiner rejected claims 1, 2, 10-13, 17, and 18 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement (Ans. 2-3)
B. The Examiner rejected claims 1, 2, 10-13, 17, and 18 under 35 U.S.C.
§ 103(a) as obvious over Curd2 and Wolfe3 (Ans. 3--4).
2 Curd et al., US 7,820,161 Bl, issue Oct. 26, 2010.
3 Frederick Wolfe, The epidemiology of drug treatment failure in
rheumatoid arthritis, 9 Balliere' s Clinical Rheumatology 619---632
(1995).
2
Appeal2014-003726
Application 13/178,307
A. 3 5 U.S. C. § 112, first paragraph
The Examiner finds that "[t]here is no support in the specification as
originally filed for the recitation of 'and having failed methotrexate therapy'
in claim 1" consistent with "the scope of the claimed invention which
encompasses use of anti CD74 antibody to treat any autoimmune disease".
(Ans. 2-3).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the phrase "having failed
methotrexate therapy" lacks descriptive support in the Specification?
Findings of Fact
1. The Specification teaches that
it is an object of the present invention to provide a method for
treating autoimmune diseases using antibody to a B-cell
antigen. It is another object of the invention is to use
comparatively low doses of a naked antibody to a B-cell
antigen, preferably to CD22 antigen, or a combination of naked
antibodies to a CD22 antigen and another B-cell antigen,
preferably CD20 and/or CD74.
(Spec. 2, 11. 20-25).
2. The Specification teaches that:
In an alternative embodiment, the antibodies to the
CD22, CD20, CD19, and CD74 or HLA-DR antigen are
conjugated to a drug .... Drugs which are known to act on B-
cells, plasma cells and/or T-cells are particularly useful in
accordance with the present invention, whether conjugated to a
B-cell antibody, or administered as a separate component in
combination with a naked or conjugated B-cell antibody. These
include methotrexate
(Spec. 16, 1. 19 to 17, 1. 2).
3
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Application 13/178,307
3. The Specification teaches, in Example 3, that a "60-year-old
male, with severe progressive rheumatoid arthritis of the finger joints, wrists,
and elbows, has failed therapy with methotrexate, and obtains only minor
relief when placed on Enbrel therapy. The patient is then treated with hLL2,
600 mg intravenously each week, for a period of eight weeks" (Spec. 21, 11.
13-16).
4. The Specification teaches that "a suitable murine anti-CD22
monoclonal antibody is the LL2 (formerly EPB-2) monoclonal antibody
(Spec. 8, 11. 21-22).
Principles of Law
"[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure ... or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement." Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010)(citations omitted).
Analysis
Appellants contend that "the various particulars of the disclosure, to
include the examples, with respect to anti-CD22 antibodies would be
understood by those of ordinary skill in the art to apply equally to other
classes of antibodies, such as anti-CD74 antibodies" (App. Br. 3).
Appellants contend that
in asserting lack of written description on the part of appellant,
the examiner reads much into the fact that "the only disclosure"
of a particular combination relates to a different combination
found in an example. In contrast, when the examiner asserts
obviousness (below) he chooses to ignore that "the only
4
Appeal2014-003726
Application 13/178,307
disclosure" of a combination is found in conjunction with f!:
different combination.
(App. Br. 4).
We find that the Examiner has the better position. We agree with the
Examiner that the Specification does not demonstrate possession of a
method for treating an autoimmune disorder with an anti-CD74 antibody or
fusion protein in a subject who failed methotrexate therapy. The focus of
the Specification is treatment with anti-CD22 antibodies, that may be used in
combination with other antibodies such as anti-CD74 (FF 1) and example 3
discloses treatment with an anti-CD22 antibody after methotrexate treatment
failure (FF 3--4), but does not disclose treatment with an anti-CD74 antibody
after methotrexate treatment failure.
While we agree with Appellants that the Specification renders the
claimed method obvious, the Examiner correctly notes that obviousness is
not the standard for written description (see Ans. 5). As Lockwood explains
"[ e ]ntitlement to a filing date does not extend to subject matter which is not
disclosed, but would be obvious over what is expressly disclosed. It extends
only to that which is disclosed." Lockwood v. American Airlines, Inc., 107
F.3d 1565, 1571-1572 (Fed. Cir. 1997). "A description which renders
obvious the invention ... is not sufficient." Id.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that the
phrase "having failed methotrexate therapy" lacks descriptive support in the
Specification.
5
Appeal2014-003726
Application 13/178,307
B. 35 U.S.C. § 103(a) over Curd and Wolfe
The Examiner finds that Curd teaches "treatment of autoimmune
disease with humanized antiCD74 antibody" but Curd does "not teach that
the patient has previously failed methotrexate therapy" (Ans. 3). The
Examiner finds that Wolfe teaches "that some patients with RA [rheumatoid
arthritis] fail methotrexate therapy" (Ans. 3).
The Examiner finds the Curd and Wolfe render the claims obvious
because "it was known in the art that some RA patients fail methotrexate
therapy" so it would have been "routine medical practice that such patients
would be treated with a different art known therapy to treat the disease"
(Ans. 8 (emphasis in original)).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion Curd and Wolfe render claim 1
obvious?
Findings of Fact
5. Curd teaches a "method of treating an autoimmune disease in a
mammal comprising administering to the mammal a therapeutically
effective amount of an antagonist which binds to a B cell surface marker"
(Curd, col. 2, 11. 60-64).
6. Curd teaches that "[ e ]xamples of autoimmune diseases or
disorders include, but are not limited to ... rheumatoid arthritis" (Curd, col.
3, 11. 50-62).
7. Curd teaches that "[ e ]xemplary B cell surface markers include
the ... CD74 ... leukocyte surface marker[]" (Curd, col. 3, 11. 13-17).
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Application 13/178,307
8. Curd teaches that the "preferred antagonist comprises an
antibody" (Curd, col. 4, 11. 31-32).
9. Curd teaches that the "monoclonal antibodies herein
specifically include 'chimeric' antibodies ... 'Humanized' forms of non-
human (e.g., murine) antibodies are chimeric antibodies that contain
minimal sequence derived from non-human immunoglobulin" (Curd, col. 7,
11. 41---60).
10. Wolfe teaches that the "length of time that patients remain on
anti-rheumatic therapy is an important measure of the effectiveness of that
therapy ... we will use the newer terminology, SMARD, or symptom-
modifying anti-rheumatic drug" (Wolfe, Abstract).
11. Wolfe asks "[ w ]hy do patients . . . change from one therapy to
another" (Wolfe 624).
12. Table 4 of Wolfe is reproduced below:
Table 4. Reasons for drug discontinuation.
1. Lack of effkacy
2. Adverse :reactions
3. Costs
4. Psychological factors.
5. Conc