Ex Parte 6653104 et al

Patent Trial and Appeal Board

Jul 24, 2014

95000062 (P.T.A.B. Jul. 24, 2014)

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.
95/000,062 12/03/2004 6653104 IMMU-0001 5745
37013 7590 07/25/2014
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
EXAMINER
TURNER, SHARON L
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
07/25/2014 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 PATENT TRIAL AND APPEAL BOARD
____________

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Requester and Respondent

v.

X
IMMUNOMEDICS, INC.
Patent Owner and Appellant
____________

Appeal 2014-006966
Reexamination Control 95/000,062
Patent 6,653,104 B2
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on an appeal by Patent Owner from the Patent Examiner’s
rejections of claims 1-50 and 141-172 in the above-identified inter partes
reexamination proceeding. The Board’s jurisdiction for this appeal is under 35
U.S.C. §§ 6(b), 134(b), and 315. We affirm.
Appeal 2014-006966
Reexamination Control 95/000,062
Patent 6,653,104 B2

2

STATEMENT OF CASE
This appeal involves US 6,653,104 (“the ’104 Patent”) which issued
November 25, 2003. The inventor is named as David M. Goldenberg. The
assignee and real party in interest is Immunomedics, Inc. (“Patent Owner”).
Appeal Br. 1 (May 6, 2013) (“2013 Appeal Br.”).
A Request for Inter Partes Reexamination of the ’104 Patent was submitted
by third-party requester, the U.S. Department of Health and Human Services, on
December 3, 2004 under 35 U.S.C. §§ 311-318 and 37 C.F.R. §§ 1.902-1.997.
Prosecution was subsequently closed after the Examiner rejected all the claims and
an Appeal Brief was filed May 3, 2010 (“2010 Appeal Br.”). The Examiner
responded by reopening prosecution. Non-Final Action dated June 23, 2011.
Subsequently, an Action Closing Prosecution (July 25, 2012) and Right of Appeal
Notice (“RAN”; February 5, 2013) were issued by the Examiner in which all the
pending claims, 1-50 and 141-172, were rejected. Patent Owner appeals the
rejections set forth in the RAN. Notice of Appeal (March 5, 2013). An Appeal
Brief (“2013 Appeal Br.”) was filed May 6, 2013. The Requester has not filed a
response.
The claimed subject matter is directed to a cytotoxic reagent that comprises
a fusion between an antibody and a moiety having ribonucleolytic activity. The
reagent is also referred to as an immunotoxin. ’104 Patent, col. 1, ll. 25-27. The
reagents are described as useful, inter alia, to treat tumors and lymphomas. Id. at
col. 2, ll. 55-65. The “moiety having ribonucleolytic activity” is defined as a
compound which cleaves ribonucleotides. Id. at col. 6, ll. 25-30. The moiety
includes ribonucleases (“RNases”) from different sources, preferably non-human.
Id. A preferred RNase is onconase or the “onc protein” which is an RNase A
Appeal 2014-006966
Reexamination Control 95/000,062
Patent 6,653,104 B2

3

obtained from the frog, Rana pipiens. Id. at col. 7, ll. 26-29. According to the
’104 Patent, the “cytotoxicity of RNase A toward tumor cells is well documented
from studies performed in the 1960s and 1970s.” Id. at col. 2, ll. 34-35. The
patent also teaches that the cytoxicity of onconase towards cancer cells was known.
Id. at col. 2, ll. 40-45.
The claims stand rejected as follows:
1. Claims 1-7, 19-21, 24-30, 33-35, 37, 39, 41, 42, 45-49, 141, 142, 148-
157, 161-164 and 167-172 under 35 U.S.C. § 103(a) as obvious in view of Youle
1

and Rybak (‘840) II
2
with evidence from Ravel
3
and Shapiro.
4

2. Claims 8, 10-12, 22, 23, 32, 40, 43, 44, 50, 158-160, 165 and 166 under
35 U.S.C. § 103(a) as obvious in view of Youle and Rybak (‘840) II as evidenced
by Shapiro and Ravel, and further in view of Rybak III,
5
Boix,
6
Kreitman,
7

French,
8
Hansen,
9
Stein 1993,
10
Vitetta,
11
and Ohsawa.
12

1
Youle et al., US 6,649,392 B1, Nov. 18, 2003.
2
Rybak et al., US 5,840,840, Nov. 24, 1998.
3
Sophie Ravel et al., Internalization and Intracellular Fate of Anti-CD5
Monoclonal Antibody and Anti-CD5 Ricin A-Chain Immunotoxin in Human
Leukemic T Cells, Blood, Vol. 79(6) pp. 1511-1517 (1992).
4
Robert Shapiro et al., Expression of Met-(-1) Angiogenin in Escherichia coli:
Conversion to the Authentic