Free Declaration - District Court of Delaware - Delaware

Case 1:07-cv-00780-SLR

Document 10

Filed 01/16/2008

Page 1 of 3

Case 1:07-cv-00780-SLR

Document 10

Filed 01/16/2008

Page 2 of 3

Case 1:07-cv-00780-SLR

Document 10

Filed 01/16/2008

Page 3 of 3

Case 1:07-cv-00780-SLR

Document 10-2

Filed 01/16/2008

Page 1 of 6

EXHIBIT A

Case 1:07-cv-00780-SLR

Document 10-2

Filed 01/16/2008

Page 2 of 6

Case 1:07-cv-00780-SLR

Document 10-2

Filed 01/16/2008

Page 3 of 6

The notice must be in the form of a photocopy of the Appendix attached to this ORDER with old may an dates crossed out and new dates inserted by hand. The ~arties not sti~ulate extension of

TIME PERIODS 7 or 8.
1 .

TIME PERIOD 1
a.

File and serve all authorized motions and Serve but do not file evidence in support of these motions.

b.

If no party files a motion, arrange a conference caIl to the administrativepatent judge so that appropriate adjustments to the schedule may be made.
2.

TIME PERIOD 2
a.
b.

File and serve responsive motions (Bd. R. 121(a)(2)) in response to

an opponent's motion filed during TIME PERIOD 1 and
Sei-vebut do not file evidence in support of these responsive motions.
3.

TIME PERIOD 3
a.

File and serve oppositions to all motions, including responsive motions and Serve but do not file evidence in support of these oppositions.
File and serve replies to all oppositions and

b.
4.

TIME PERIOD 4
a.

b.
5.

Serve but do not file evidence in support of these replies. File and serve any request for oral argument on motions, File and serve motions to exclude evidence @d. R 155(c); SO

TIME PERIOD 5
a.

b.

fi 21.3), and
c.

File and serve observationson cross examination (SO 7 22.7) ofreply testimoily.

before opposition or reply is due, SO ij22.1.2).

Case 1:07-cv-00780-SLR

Document 10-2

Filed 01/16/2008

Page 4 of 6

6.

'TIME PERIOD 6
a.

File and serve oppositions to an opponent's motion to exclude evidence and File and serve any response to observations. File and serve replies to oppositions to motions to exclude evidence.

b. 7.

TIME PERIOD 7

B. Deposition transcripts
Transcripts of cross examinations and depositions taken under 35 U.S.C. served, but not filed, until the exhibits are filed.

5 24 must be

C. Serving exhibits relied upon in motions
An exhibit, including an affidavit, cited in connection with a motion, opposition, reply, or

affidavit, must be sewed, but not filed: with the motion, opposition, reply or &davit in which the exhibit is first mentioned.
D.

TIME PERIOD 8: Filing the record for decision on motions I.
2.

File an original set of your exhibits and one working copy (or three copies if
an oral argument is set) of your exhibits;

For each of y o u motions, file one folder (or three folders if an oral argument
is set each) containing:
a.
b.

The motion,
Any corresponding opposition,

c.
d.

Any corresponding reply, Any corresponding observations, and Any corresponding response to the observations.

e.

3.
I.

File any Z P 100 Mb disk or CD-ROMa party elects to file. I@

E. Priority statements

At TIME PERIOD 1:

Except when the Board sets an expedited schedule for a particular motion, in which case, all exhibits mentioned in that motion or the corresponding opposition or reply must be filed with the motion, opposition, reply, or affidavit in which the exhibit is first mentioned.

Case 1:07-cv-00780-SLR

Document 10-2

Filed 01/16/2008

Page 5 of 6

a.

File but do not serve a priority statement (Bd. R 120; Bd.R 204(a)).

b.
2.

File and serve a notice advising each opponent of the filing of the
priority statement.

A junior party who does not file a priority statement shall not have access to
the priority statement of any other party.

3.

Within one (1) week after TIhE PERZOD 1, serve a copy of the priority

statement upon each opponent who served a notice under f G. 1.b above.

/SS/Richard E. Schafer RICHARD E. SCHAFER Administrative Patent Judge Date: Arlington, VA
cc (via Federal Express):
Attorney for Human Genome Sciences:

STERNE KESSLER GOLDSTEIN & FOX PLLC
1 I00 New York Avenue Suite 600 Washington, DC 20005-3934

Tel:
Fax:

202-37 1 -2600 202-371 -2540

Attorney for Immunex:

IMMUNEX CORPORATION Law Department 1201 Arngen Court West Seattle, WA 98 119
Tel:

206-265-7000

Case 1:07-cv-00780-SLR

Document 10-2

Filed 01/16/2008

Page 6 of 6

Appendix--ORDER RULE 123(a) (Times for substantive motions; priority deferred)

-

Interference 105,36 1 (RES)
TIME PERIOD 1 ............................................... December 7,2005 File motions File (but serve one week later) priority statements

TIMEPEEUOD2 ................................................. January4,2006 File responsive nlotions to motions filed in T M E PERIOD 1

TIME PERIOD 3 ................................................ February 8,2006 File oppositions to all motions TIME PERIOD 4 ................................................. March 22,2006 File all replies

TIME PERIOD 5

....................................................May 3,2006

File request for oral argument File motions to exclude File observatio~~s

TIME PERIOD 6 ................................................... File oppositions to motions to exclude File response to observations

May 24,2006

TIME PERIOD 7 .................................................... June 7,2006 File replies to oppositions to motions to exclude

TIME PERIOD 8 ................................................... June 14,2006 File exhibits File sets of motions File any ZIP@ disks or CD-ROMs

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 1 of 7

EXHIBIT B

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 2 of 7

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 3 of 7

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 4 of 7

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 5 of 7

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 6 of 7

Case 1:07-cv-00780-SLR

Document 10-3

Filed 01/16/2008

Page 7 of 7

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 1 of 74

EXHIBIT C

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 2 of 74

The opinion in support of the decision being entered today is not binding precedent of the Board.

Paper 133
By: Trial Section Merits Panel Board of Patent Appeals and Interferences Mail Stop Interference P.O. Box 1450 Alexandria, VA 22313-1450 Tel: 571-272-9797 Fax: 571-273-0042 Filed: July 26, 2007

UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND. INTERFERENCES (Administrative Patent Judge Richard E. Schafer)

.
[

*

ijUL 2 6 2009

!:/;;!;:;;:

, .::,:;:,-,,. ,.,:..

..

:, ; ::::. . ,.,

Human Genome Sciences, Inc. Junior Party (Patent 6,872,568; Inventors: Jian Ni, Reiner L. Gentz, Guo-Liang Yu and Craig A. Rosen),

lmmunex Corp. Senior Party, (Application 091378,045; Inventors: Charles Rauch and Henning Walczak). Patent Interference 105,240 (RES)

Before: SCHAFER, HANLON and SPIEGEL, Administrative Patent Judges. SPIEGEL, Administrative Patent Judge. DECISION MOTIONS Bd.R. 125(a)

-

-

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 3 of 74
Page 2 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

1.

Introduction

This is a decision on the motions remaining in interference 105,240. Junior party Ni has filed seven motions, three of which have been previously decided.' Senior party Rauch has filed eight motions, one of which has been previously decided.* Ni motion 3 for benefit is dismissed as to Ni proposed count 2 and otherwise denied. Ni motion 4 to substitute the count is denied. Ni motion 6 for benefit as to Rauch proposed counts 1 and 2 is dismissed. Ni motion 7 to exclude evidence is denied. Rauch motion 2 to substitute the count and add a second count is denied. Rauch motion 3 for benefit is dismissed as to Rauch proposed count 1 and otherwise granted. Rauch motion 4 to add claims to its involved application is
denied. Rauch motion 5 to designate Ni '568 patent claims 7, 20, 33 and 46 as

corresponding to Count 1 is denied. Rauch motion 6 that all of Ni's involved claims are unpatentable over the prior art is denied. Rauch motion 7 to exclude evidence is denied.
II. Findings of Fact (FF)

The following findings of fact are supported by a preponderance of the evidence.

Ni motion 1 (Paper 26) to synchronize time periods in interferences 105,240 and 105,361 has already been granted (Paper 34). Ni motion 2 (Paper 32) requesting additional discovery has already been denied (Papers 59 and 78). Ni motion 5 (Paper 42) to hold all of Rauch's involved claims unpatentable under 35 U.S.C. 9 102(e) over U.S. Patent 6,872,568 or under § 102(e)/103 over U.S. Patent 6,872,568 in view of secondary references has already been denied (Papers 65 and 96). Rauch motion 1 (Paper 28) to synchronize time periods in interferences 105,240, 105,380 and 105,381 has already been denied (Paper 35).

1

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 4 of 74
Page 3 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)
[I]

The junior party is Jian NI, Reiner L. GENTZ, Guo-Liang YU and Craig A. ROSEN ("Ni").

[2]

Ni is involved in the interference on the basis of U.S. Patent 6,872,568 ("the '568 patent," NX 2004), granted 29 March 2005, based on application 091565,009, filed 4 May 2000.

[3] [4] [s]

Nils real party-in-interest is Human Genome Sciences, Inc. ("HGS"). The senior party is Charles RAUCH and Henning WALCZAK ("Rauch"). Rauch is involved on the basis of application 091378,045 ("the '045 application," RX 1004), filed 20 August 1999.

[6] [7]
[8]

Rauch's real party-in-interest is lmmunex Corp. ("lmmunex"). The subject matter of the interference is defined by one count. Count 1 is "Claim 21 of Ni U.S. Patent 6,872,568 or Claim 84 of Rauch Application 091378,045" (Paper 1, p. 3).

[g]

Claim 21 of the '568 patent, written in independent form, reads: An isolated monoclonal antibody or fragment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2, wherein said antibody or fragment thereof is an antagonist of the protein of SEQ ID NO:2.

[lo]

According to the '568 patent, SEQ ID NO:1 and SEQ ID NO:2 are the nucleotide and deduced amino acid sequences, respectively, of a human Death Domain Containing Receptor 5 polypeptide ("DR5") (NX 2004, col.

[II]

Amino acid residues 1 to 133 of SEQ ID NO:2 are said to represent the extracellular domain ("ECD") of DR5 (NX 2004, col. 4, 11. 57-60).

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 5 of 74
Page 4 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch) [12]

Further according to the '568 patent, DR5 is said to bind TRAIL (NX 2004,

[i3]

TRAIL (TNF-Related Apoptosis-Inducing Ligand) is a member of the tumor necrosis factor ("TNF") ligand family known to be capable of inducing apoptosis3when added to certain cells, e.g., Jurkat cells (NX

[i4]

The '568 patent defines antibodies which inhibit DR5 activities as DR5 antagonists (NX 2004, col. 79, 11. 53-56).

[As]

Claim 84 of the '045 application, written in independent form, reads: A composition comprising a plurality of isolated antibodies or antigen-binding fragments thereof; wherein each of said antibodies or antigen-binding fragments of said plurality specifically binds to an isolated and purified human TRAIL-R receptor protein, wherein said isolated and purified human TRAIL-R receptor protein is a product made by the process comprising the steps of: (a) (b) (c) isolating plasma membranes from Jurkat cells; solubilizing and homogenizing said isolated plasma membranes of step (a); centrifuging said solubilized and homogenized isolated plasma membranes of step (b) to yield a plasma membrane extract and a pellet; applying said plasma membrane extract of step (c) to an anti-ocatapeptide monoclonal antibody affinity chromatography column, whereby said column of step (d) adsorbs nonspecifically bound material and wherein said

(d)

Apoptosis refers to a programmed cell death, i.e., a cell, in response to specific physiological or developmental signals undergoes a regulated series of events that will lead to its death and removal from an organism. 4 Wiley et al., "Identification and Characterization of a New Member of the TNF Family that Induces Apoptosis," Immunity, Vol. 3, pp. 673-682 (December 1995) (NX 2096).

3

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 6 of 74
Page 5 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

octapeptide has the sequence presented in SEQ ID NO:5; (e) applying column flow-through from step (d) to an octapeptide-TRAIL ligand affinity chromatography column, whereby said column of step (e) specifically binds said TRAIL-R receptor protein and wherein said octapeptideTRAIL ligand is a fusion protein of said octapeptide having the sequence presented in SEQ ID NO:5 and TRAIL ligand; eluting fractions with TRAIL ligand binding activity from said column of step (e); and purifying said fractions of step (f) by reversephase HPLC to yield said isolated and purified TRAIL-R receptor protein, wherein said isolated and purified TRAIL-R receptor protein has a molecular weight of about 50 to 55 kilodaltons as determined by SDS polyacrylamide gel electrophoresis, and comprises the amino acid sequence VPANEGD (amino acids 327-333 of SEQ ID NO:2),

(f) (g)

wherein said antibodies or antigen-binding fragments specifically bind to membranes of Jurkat cells and also block binding of TRAIL ligand to said TRAIL-R receptor protein.
[I61 The protein referred to as "TRAIL-R in the '045 application is also referred

to as TRAIL-R2, TR-2, Apo-2, TRICK2, KILLER or DR5 in the art and will be referred to as "TRAIL-R2" in this decision.
[I71

TRAIL-R2 and DR5 are isoforms of the same p r ~ t e i n . ~

Wang et al., "Coordinated regulation of two TRAIL-R2IKILLEWDR5 mRNA isoforms by DNA damaging agents, serum and 1713-estradiol in human breast cancer cells," Breast Cancer Research and Treatment, Vol. 61, pp. 87-96 (2000) (copy enclosed). lsoforms are variants of the same protein between various tissues, developmental stages, etc. with some small differences, usually a splice variant or the product of some posttranslational modification). TRAIL-R2 is the 440 amino acid "long" isoform; DR5 is the 41 1 amino acid "short" isoform.

5

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 7 of 74
Page 6 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)
[18]

Thus, the subject of Count 1 encompasses (a) not only isolated monoclonal antibodies or fragments thereof which specifically bind to the ECD of DR5 and antagonize DR5 activity, (b) but also compositions of isolated antibodies or fragments thereof which specifically bind to the membranes of Jurkat cells and simply block the binding of TRAIL to

[ig]

The claims of the parties are: Ni Rauch 1-52 82-94, 100-103, 105-117

[20]

The claims of the parties which correspond to Count 1 are: Ni Rauch 1-6, 8-19,21-32, 34-45,47-52 82-94, 100-103, 105-117

1211

The claims of the parties which do not correspond to Count 1, and therefore are not involved in the interference, are: Ni Rauch 7, 20, 33,46 none

Other findings of fact follow below.

Ill.

Ni Motion 4 Pursuant to 37 CFR § 41 .I21(a)(l )(i), Ni moves to redefine the scope of

the interference by substituting Ni proposed count 2 for current Count 1 (Paper 41). Rauch opposes (Paper 74); Ni replies (Paper 82).
[22]

Ni proposed count 2 reads (Paper 41, p. 1, TI): An isolated antibody or fragment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2, wherein said antibody or fragment thereof is an antagonist of the protein of SEQ ID NO:2,

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 8 of 74
Page 7 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

or Claim 84 of Rauch Application 091378,045. It is our understanding that the source of SEQ ID NO:2 in Ni proposed count 2 is Ni's involved '568 patent. With this understanding, we now address Ni motion 4. According to Ni, its proposed count 2 simply incorporates Ni claims 15 and 21, as does the current count, and deletes the limitation that the antibody is "monoclonal" (Paper 41, p. 1,jil). Ni argues that its best proofs of conception of the subject matter of Count 1 do not specifically refer to "monoclonal" antibodies (id., p. 3, m2-3). A party seeking to change the count in an interference must demonstrate a genuine need to change the count. As stated in Louis v. Okada, 59 USPQ2d 1073, 1076 (Bd. Pat. App. & Int. 2001), [a]t a minimum, . . . a preliminary motion to broaden out the count on the basis that a party's best or earliest proofs are outside the current count (1) should make a proffer of the party's best proofs, (2) show that such best proofs do indeed lie outside of the scope of the current count, and (3) further show that the proposed new count is not excessively broad with respect to what a party needs for its best proofs. Ni seeks to change Count 1 by deleting the limitation that the antibody is "monoclonal" because "[[tlhe phrase 'monoclonal antibodies' is not used specifically in reference to the subject matter of the count by any one of Party Ni's best proofs" (Paper 41, p. 3, 73). Ni has not demonstrated a genuine need to change the count. Ni stated that its best proofs do not show a "monoclonal" antibody. However, Ni has not proffered what its best proofs andlor other evidence will show, e.g., Ni has not

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 9 of 74
Page 8 Paper 133

lntelference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

alleged that they will show an embodiment within the scope of Ni proposed count 2. Without knowing what Nils best proofs and/or other evidence are alleged to show, there is an insufficient basis to determine whether a genuine need to change the count exists or to give Rauch a fair opportunity to address the need for a substitute count as proposed by Ni. "The party filing the motion has the burden of proof to establish that it is entitled to the requested relief." 37 CFR 5 41 .I21(b). Ni has not satisfied its burden here. Therefore, based on the foregoing, Ni motion 4 is denied.

IV.

Ni Motion 3
Pursuant to 37 CFR § 41.121(a)(l)(ii), Ni moves to be accorded benefit of

the filing dates of six certain priority applications for the subject matter of Count 1 and, contingent upon the granting of Ni motion 4, for the subject matter of Ni proposed count 2 (Paper 40). Rauch opposes (Paper 73); Ni replies (Paper 81). In view of our denying Ni motion 4, Ni motion 3 is dismissed as moot as to Ni proposed count 2 since the contingency has not been met. Therefore, we address Ni motion 3 as it relates to current Count 1. To be accorded benefit for the purpose of priority in an interference proceeding "means Board recognition that a patent application provides a proper constructive reduction to practice under 35 U.S.C. 102(g)(l)." 37 CFR § 41.201.

A constructive reduction to practice "means a described and enabled anticipation
under 35 U.S.C. 102(g)(l) in a patent application of the subject matter of a count." Id. Benefit for the purpose of priority focuses on the subject matter of a count and only requires a constructive reduction to practice of a single

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 10 of 74
Page 9 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

embodiment within the scope of the count. Faulkner v. Inglis, 463 F.3d 1376, 1379,79 USPQ2d 1001, 1004 (Fed. Cir. 2006); Hunt v. Treppschuh, 523 F.2d 1385, 1389, 187 USPQ 426, 429 (CCPA 1975).6 To fulfill the written description, the patent specification must describe an invention in sufficient detail that one of ordinary skill in the art can clearly conclude that the inventor invented what is claimed. Lockwood v. Am. Airlines, 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Furthermore, the earliest constructive reduction to practice "means the first constructive reduction to practice that has been continuously disclosed through a chain of patent applications including the involved patent application or patent." 37 CFR § 41.201. "For the chain to be continuous, each subsequent application must have been co-pending under 35 U.S.C. 120 or 121 or timely filed under 35 U.S.C. 119 or 365(a)." Id. "The party filing a motion has the burden of proof to establish that it is entitled to the requested relief." 37 CFR § 41.121(b). As part of its burden of proof Ni must present admissible evidence and explain how the evidence supports the relief requested. Ni has failed to meet its burden both procedurally and substantively. Ni has failed to show that any of the six certain applications, i.e., applications 601040,846; 601054,021; 091042,583; 601132,498; 601133,238; 601148,939; 601054,021; and, 601040,846, describes a constructive reduction to practice of a single embodiment within the scope of Count 1.

In contrast, benefit for the purpose of 35 U.S.C. 9 120 and related statutes focuses on the subject matter of a claim and requires the application for which benefit is sought to describe and enable the entire scope of the claim.

6

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 11 of 74
Page 10 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

Nits involved '568 patent issued from its '009 application (FF 2).
[23]

Nits '009 application was not accorded benefit for the purpose of priority of any earlier filed applications when the interference was declared.

[24]

The '009 application is said to be a continuation-in-part of application 091042,583 ("the '583 application," NX 2024, title page, § 63).

[25]

When the '583 application was filed, it claimed benefit of the filing dates of provisional applications 601054,021 ("the '021 application," NX 2056) and
§ 601040,846 ("the '846 application," NX 2042) under 35 U.S.C. 119(e)

(NX 2024, p. I , 11. 12-14).
[26]

When the '009 application was filed, it also claimed benefit of the filing dates of provisional applications 601132,498 ("the '498 application," NX 2063), 601133,238 ("the '238 application," NX 2064) and 601148,939 ("the '939 application," NX 2065) (NX 2004, col. 1, 11. 7-10). Thus, Ni motion 3 requires analysis of five "chains" of applications: (1) (2) (3) (4) the '009 application back to the '939 application, the '009 application back to the '238 application, the '009 application back to the '498 application, the '009 application back through the '583 application to the '021

application, and (5) the '009 application back through the '583 application to the '846

application for an embodiment within the scope of Count 1. The fourth and fifth chains contain a common intermediate "link," the '583 application. Hence, we

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 12 of 74
Page 11 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmrnunex Corp. (Rauch)

group the first three chains together and the last two chains together for discussion purposes.

A.

Group I: applications '498, '238 and '939

First, Ni has made no attempt whatsoever to identify where the disclosure of the '939, '238 or '498 applications provide a constructive reduction to practice of the subject matter of Count 1. Ni argued in toto: HGS's later filed priority applications (091042,583, filed March 17, 1998; 601132,498, filed May 4, 1999; 601133,238, filed May 7, 1999; and 601148,939, filed August 13, 1999) contain at least the same disclosure as is found in the March 17 and July 29, 1997 priority applications. Moreover, nothing in the later filed priority applications provides any basis for doubting the assertions of the March 17, 1997 and July 29, 1997 priority applications. Thus, for at least the same reasons that the March 17,1997 and July 29, 1997 priority applications enable and describe embodiments of count 1 and of proposed count 2, it follows that the later filed priority applications also enable and describe embodiments of count 1 and proposed count 2. [Paper 40, bridging pp. 22-23, emphasis added.] Ni should have shown where each of the '498, '238 and '939 applications described an enabled embodiment of the subject matter of Count 1 and how that description was carried forward into the '009 application. The '498, '238 and '939 applications are lengthy documents.
[27] The '568 patent (NX 2004), which Ni submitted in lieu of the '009

application, includes an abstract, twelve sheets of drawings, one hundred fifty-eight columns of text (including sequences) and fifty-two claims.
[28]

Since Ni did not enter a copy of the originally filed '009 application into evidence, the '568 patent cannot be used to establish whether the '009

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 13 of 74
Page 12 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

application contained any original claims directed to antagonist anti-ECD DR5 antibodies.
[29]

The '498 application (NX 2063) includes an abstract, seven sheets of drawings, one hundred sixty-six pages of text (including sequences) and thirty-four claims.

[30] The '238 application (NX 2064) includes an abstract, one hundred sixtyfour pages of text (including sequences), fourteen sheets of drawings and thirty-four claims.

[a] The '939 application (NX 2065) includes an abstract, one hundred eightythree pages of text and thirty-four claims.
[32]

The '021 application (NX 2065) includes an abstract, fifty-one pages of text, seven sheets of drawings and twenty-four claims.

[33]

The '846 application (NX 2042) includes an abstract, forty-four pages of text (including sequences), four sheets of drawings and nineteen claims. It is not the job of the Board to pour through hundreds of pages of text and

sheets of drawings to find disclosure alleged to be "at least the same disclosure as is found in the March 17 and July 29, 1997 priority applications." See United States v. Dunkel, 927 F.2d 955,956 (7th Cir. 1991) ("[jludges are not like pigs hunting for truffles buried in briefs"). It is not the fact finder's burden to search through lengthy technology-intense documents for possible evidence which may support Nits "at least the same reasons." The descriptive text and figures in each of the '009 (to the extent shown in the '568 patent), '498, '238 and '939 application is anywhere from approximately three to five times greater than that

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 14 of 74
Page 13 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

in either the '846 or '021 application. Ni has failed to provide any guidance as to where any of the specifications and/or figures of the '009, '498, '238 or '939 applications contain disclosure corresponding to the particular disclosure relied upon by Ni in either the '846 or '021 application. Ni has failed to provide any explanation as to why "at least the same reasons" said to apply to the '846 and '021 applications would be equally applicable to the disclosures of any of the '009, '498, '238 or '939 applications. Given the substantially greater amount of text and figures in each of the '009, '498, '238 and '939 applications, any one or more of these applications may or may not support any one of more of Ni's "at least the same reasons." Ni cannot simply piggyback the disclosure of one provisional application upon that of another provisional application for purposes of priority any more than one provisional application can claim priority benefit of another provisional application. Compare 35 U.S.C. § 111(b)(7). The disclosure of each provisional application stands on its own footing. It is Ni's burden to present substantive reasons as to why specifically identified disclosure in each of the '498, '238 and '939 applications provide a constructive reduction to practice of the subject matter of Count 1. Otherwise, Ni has failed to show that the '009 application is

prima facie entitled to benefit for the purpose of priority of the filing date of the
'498, '238 and/or '939 application(s). Based on the foregoing, Ni has not established that it is prima facie entitled to benefit for the purpose of priority of (i) the 4 May 1999 filing date of the '498 application, (ii) the 7 May 1999 filing date of the '238 application, or (iii) the

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 15 of 74
Page 14 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

13 August 1999 filing date of the '939 application as to the subject matter of Count 1.

B.

Group II: linked applications '583/'846 and '583/'021

Ni has failed to identify where the disclosure of the '583 application provides a constructive reduction to practice of the subject matter of Count 1. Since the '583 application is the parent application of the '009 application, it is proper to address the disclosure in the '583 application before addressing the disclosure in either the '846 or '021 application. If the '583 application does not provide a constructive reduction to practice of the subject matter of Count 1 which was carried forward into the '009 application, the chain is broken and we do not reach either earlier filed '846 or '021 application. As noted above (FF 24), the '009 application is said to be a continuationin-part of the '583 application and, therefore, presumptively includes subject matter different from its parent '583 application. Ni has failed to identify where the '583 application describes an enabled embodiment within the scope of Count 1 and how this disclosure was carried forward into the '009 application. Instead, just as with the '498, '238 and '939 applications, Ni simply argued that the '583 application contains "at least the same disclosure as found in" the '846 and '021 applications and, therefore described and enabled embodiments within the scope of Count 1 (Paper 40, 7 bridging pp. 22-23).
[34]

The '583 application includes an abstract, sixty-seven pages of text (including sequences), thirty-four originally submitted claims and seven sheets of drawings.

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 16 of 74
Page 15 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

Ni has failed to provide any guidance as to where the '583 application provides disclosure corresponding to specific disclosures relied upon by Ni in either the '846 or '021 applications. Ni has not explained why "at least the same reasons" said to apply to the '846 and '021 applications are equally applicable to the '583 application. In other words, Ni has not addressed the disclosure of the '583 application in any meaningful way either substantively or procedurally. Ergo, we need not consider whether either the '846 or '021 provisional application describes an enabled embodiment within the scope of Count 1. Based on the foregoing, Ni has not established that it is prima facie entitled to benefit for the purpose of priority of (i) the 17 March 1998 filing date of the '583 application, (ii) the 17 March 1997 filing date of the '846 application or (iii) the 29 July 1997 filing date of the '021 application. In summary, Ni motion 3 is dismissed as moot as to benefit for the purpose of priority as to Ni proposed count 2 and otherwise denied.

V.

Rauch Motion 7

Contingent on the grant of Ni motion 4, Rauch moves pursuant to 37 CFR
§ 41.121(a)(l)(ii), to be accorded benefit of the filing dates of five certain priority

documents for the subject matter of Ni proposed count 2 (Paper 58). Ni opposes (Paper 71); Rauch replies (Paper 90). Since the contingency has not been met, we dismiss Rauch motion 7 as moot.

VI.

Rauch Motions 2 and 4

Pursuant to 37 CFR 5 41 .I21(a)(l)(i), Rauch moves to redefine the scope of the interference. Rauch seeks to substitute Rauch proposed count 1 for

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 17 of 74
Page 16 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

current Count 1 and to add Rauch proposed count 2 in its motion 2 (Paper 45). Rauch seeks to add proposed claims 118, to be designated as corresponding to Count 1 or Rauch proposed count 1, and 119, to be designated as corresponding to Count 1 or Rauch proposed count 2, to its involved '045 application in its motion 4 (Paper 47). Ni opposes (Papers 66 and 68); Rauch replies (Papers 85 and 87).

A.

Rauch proposed count 1

[35] Rauch proposed count 1 reads "Ni '568 Patent claim 1 or Rauch '045

Application claim 82" (Paper 45, p. I ) .
[36] Ni '568 patent claim 1 reads:

An isolated antibody or fragment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2.
1371 Rauch '045 application claim 82 reads:

A composition comprising a plurality of isolated antibodies or antigen-binding fragments thereof, wherein each of said antibodies or antigen-binding fragments of said plurality specifically binds to an isolated and purified human TRAIL-R receptor protein, wherein said isolated and purified human TRAIL-R receptor protein is a product made by the process comprising the steps of: (a) (b) (c) isolating plasma membranes from Jurkat cells; solubilizing and homogenizing said isolated plasma membranes of step (a); centrifuging said solubilized and homogenized isolated plasma membranes of step (b) to yield a plasma membrane extract and a pellet; applying said plasma membrane extract of step (c) to an anti-octapeptide monoclonal antibody affinity chromatography column, whereby said column of step (d) adsorbs non-specifically

(d)

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 18 of 74
Page 17 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

bound material and wherein said octapeptide has the sequence presented in SEQ ID NO:5; (e) applying column flow-through from step (d) to an octapeptide-TRAIL ligand affinity chromatography column, whereby said column of step (e) specifically binds said TRAIL-R receptor protein and wherein said octapeptideTRAIL ligand is a fusion protein of said octapeptide having the sequence presented in SEQ ID NO:5 and TRAIL ligand; eluting fractions with TRAIL ligand binding activity from said column of step (e); and, purifying said fractions of step (f) by reversephase HPLC to yield said isolated and purified TRAIL-R receptor protein,

(f) (g)

wherein said isolated and purified TRAIL-R receptor protein has a molecular weight of about 50 to 55 kilodaltons as determined by SDS polyacrylamide gel electrophoresis and comprises the amino acid sequence VPANEGD (amino acids 327-333 of SEQ ID NO:2). Rauch argues that its proposed count 1 "reflects the scope of the broadest patentable claims between the parties" (Paper 45, p. 6). Rauch further argues that its best priority proofs for Count 1 include conception and constructive reduction to practice of antibodies that specifically bind to TR-2 but do not recite a specific effect on TR-2, such as antagonizing TR-2 (Ni claim 21), or blocking TRAIL binding to TR-2, and binding to Jurkat cell membranes (Rauch claim 84) (Paper 45, p. I I). First, there is no per se rule that a count must be as broad as the parties' broadest patentable claims corresponding to the count. Lee v. Mclntyre, 55

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 19 of 74
Page 18 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

Second, it is accepted interference practice to permit the substitution of a broader count when a party's best proofs lie outside the scope of the present count. Theeuwes v. Bogentoft, 2 USPQ2d 1378,1379 (Comm'r Pat. 1986); Kondo v. Martel, 220 USPQ 47,49 (Bd. Pat. Int. 1983); Nelson v. Drabek, 212 USPQ 98 (Comm'r Pat. 1979). However, a broader count cannot be substituted where it is broadened to include another separately patentable invention. For example, if the count were drawn to species A and one party's best proofs were allegedly to species B, it would be improper to broaden the count to a Markush group of species A and B if species B was a patentably distinct invention from species A. If the count was broadened to cover species A and B, the anomalous possibility would arise that the one party could prove priority as to both patentably distinct inventions (A and B) merely by proving priority as to one of them (B). Cf. Godtfedsen v. Banner, 598 F.2d at 589,202 USPQ (D.D.C. 1980); Theeuwes, 2 USPQ2d at 1380. Furthermore, there is a rebuttable presumption that a claim which is not designated as corresponding to the count is not directed to the same patentable invention as the count. Chiong v. Roland, 17 USPQ2d 1541, 1544 (Bd. Pat. App.

& Int. 1990). Here, Ni claims 7, 20, 33 and 46, which expressly recite antibodies
that specifically bind to the ECD of DR5 (i.e., amino acids 1-133 of SEQ ID NO:2 of the '568 patent) and have agonistic activity, have been designated as not corresponding to Count 1 (FF 11 and 20). Count I , in relevant part, is directed to antibodies that specifically bind to the ECD of DR5 and have antagonistic activity (FF 18). Thus, in order for Rauch to meet its burden of proving that it is entitled

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 20 of 74
Page 19 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

to the requested relief, i.e., substituting Rauch proposed count Ifor Count 1, Rauch would have to show that antibodies which specifically bind to the ECD of DR5 and agonize the activity of DR5 define the same patentable invention as antibodies which specifically bind to the ECD of DR5 and antagonize the activity of DR5. To the contrary, Rauch itself argues that antibodies that agonize the activity of DR5 define a separate patentable invention from antibodies that antagonize the activity of DR5 (Paper 45, p. 12). Therefore, Rauch has not met its burden and Rauch motion 2 is denied to
the extent it seeks to substitute Rauch proposed count 1 for current Count 1.

B.
[38]

Rauch proposed claim 118

Rauch proposed claim 118 reads: An antibody that specifically binds to a TRAIL-R polypeptide selected from the group consisting of: (a) a polypeptide that binds TRAIL and can be isolated from human cell membranes, wherein the TRAIL-R is characterized as comprising the amino acid sequence VPANEGD (amino acids 327-333 of SEQ ID NO:2); and a fragment of (a), wherein said fragment is capable of binding TRAIL,

(b)

or an antigen-binding fragment of said antibody. "A party moving to add . . . a claim must show the claim is patentable." 37 CFR § 41.208(c)(l).
[39]

In an Office action mailed 7 February 2005 during prosecution of the '045 application, the Examiner rejected claim 43 "under 35 U.S.C. 102(e) as being anticipated by Ni et a/., Publication No. 20020098550, July 25,

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 21 of 74
Page 20 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

2002, Application No. 091005842 [sic, 101005,842] (IDS item A20)" (RX 1019, pp. 488-489).
[40]

In response to the 7 February 2005 Office action, Rauch argued that claim 43 was entitled to an effective filing date which antedated the applied prior art, cancelled claim 43 and presented claims reciting additional limitations for the Examiner's consideration (RX 1019, pp. 509-519).

[4i]

By way of an Examiner's amendment mailed 26 July 2005, the Examiner indicated that the then pending claims, i.e., Rauch's currently involved claims, were allowable (RX 1019, pp. 628-635).

[a]

Rauch admits that "[plroposed claim 118 contains fewer limitations than the pending claims involved in the interference and is identical to claim 43, which was added then cancelled during the prosecution of the '045 Application" (Paper 47, p. 4, 73). Rauch's proposed claim 118, i.e., cancelled claim 43, is broader than any

of its claims involved in this interference. During prosecution of the involved '045 application, Rauch argued cancelled claim 43 was patentable over the applied prior art, but nonetheless cancelled the claim and replaced it with claims having additional limitations. It was unnecessary for the examiner to consider the arguments that cancelled claim 43 would be patentable over the applied prior art. Thus, it is unclear on this record whether the Examiner considered cancelled claim 43 to be allowable over the applied prior art or not. Rauch's involved replacement claims are directed to antibodies which specifically bind to TRAILR2 antigen characterized as a product-by-process having a particular molecular

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 22 of 74
Page 21 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

weight range. The Examiner might have considered the product-by-process steps and/or the approximate molecular weight limitations of the replacement claims to distinguish over the applied prior art. Alternatively, Rauch might have chosen to appeal the Examiner's decision to reject claim 43 over the applied prior art rather than canceling it and replacing it with narrower subject matter. In any event, we are not here to look over the Examiner's shoulder or to review hislher decision on patentability. Therefore, we decline Rauch's invitation to determine the patentability of its proposed claim 118 over the prior art applied by the Examiner sua sponte, particularly since proposed claim 118 is broader than any of Rauch's involved claims and would not affect the scope of Count 1 or Rauch's proposed count 1 or 2. Based on the foregoing, Rauch motion 4 is denied to the extent it seeks to add Rauch proposed claim 118 to its involved '045 application. C.
[a]

Rauch proposed count 2

Rauch proposed count 2 reads "Ni '568 Patent claim 7 or Rauch '045 Application Proposed claim 119" (Paper 45, p. 1).

[44]

Ni '568 patent claim 7, written in independent form, reads: An isolated antibody or fragment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2, wherein said antibody or fragment thereof is an agonist of the protein of SEQ ID NO:2. As noted above, amino acid residues 1 to 133 of SEQ ID NO:2 of the '568

patent is said to be the ECD of DR5 (FF 11).
[45]

Rauch '045 application proposed claim 119 reads: An isolated antibody or fragment thereof that specifically binds to the extracellular domain of a

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 23 of 74
Page 22 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

protein of SEQ ID NO:2, wherein the isolated antibody or fragment thereof is an agonist of said protein.
[46]

SEQ ID NO:2 of the '045 application is said to be the 440 amino acid sequence of a human TRAIL-R2 protein encoded by the cDNA of SEQ ID NO:1 derived from human foreskin fibroblast (RX 1004, p. 2, 11. 28-29; p. 3, 11. 27-30; p. 40, "Example 3;" pp. 57-58). "Where there is more than one count, each count must describe a

patentably distinct invention." 37 CFR § 41.201. Rauch maintains that its proposed count 2 defines a patentably distinct invention from Count Ifor two reasons. First, Rauch argues that generating agonistic antibodies to TR-2 was not routine in 1997 (Paper 45, p. 7). However, Rauch has not explained why the subject matter of proposed count 2 would not have been obvious over the subject matter of Count 1. The subject matter of Count 1 relates to antibodies which specifically bind to DR5TTRAIL-R2 receptor protein and decrease (antagonize) its function, while the subject matter of proposed count 2 relates to antibodies which specifically bind to the same protein and increase (agonize) its function. There is no difference in the cognate ligand or signal used to induce activity of the TNF receptor protein of the counts. The only difference is whether the antibody turns the activity of the protein "up" (proposed count 2) or "down" (Count 1). Rauch has not shown why a skilled artisan could not generate the former antibody, given that he presumably knows how to generate the latter antibody. Secondly, Rauch argues that a separate interference 105,361 involving all of Nils '568 patent claims was declared with two counts, one directed to

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 24 of 74
Page 23 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

antibodies that antagonize the activity of DR5TTRAIL-R2 and the other directed to antibodies that agonize the activity of DRSTTRAIL-R2 (Paper 45, p. 13). The '361 interference was declared based on a different record. Different facts lead to different conclusions. Therefore, since Rauch has not shown that the subject matter of its proposed count 2 is separately patentable from the subject matter of Count 1, Rauch motion 2 is denied to the extent it seeks to add Rauch proposed count 2 to the interference.

D.

Rauch proposed claim 119

Since Rauch has not shown that the subject matter of its proposed count 2 is separately patentable from the subject matter of Count, there is no reason to add proposed claim 119 to the '045 application. In other words, Rauch has failed to show that it is entitled to the relief requested. 37 CFR § 41.121(b). Therefore, based on the foregoing, Rauch motion 4 is denied to the extent it seeks to add Rauch proposed claim 119 to its '045 application.

E.

Summary

In summary, Rauch motion 2 to substitute Rauch proposed count 1 for current Count 1 and to add Rauch proposed count 2 is denied. Further, Rauch motion 4 to add Rauch proposed claims 118 and 119 to its involved '045 application is denied.

VII.

Ni Motion 6

Contingent on the grant of Rauch motion 2, Ni moves pursuant to 37 CFR
§ 41.121(a)(l)(ii), to be accorded benefit of the filing dates of "its priority

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 25 of 74
Page 24 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

applications" for the subject matter of Rauch proposed counts Iand 2 (Paper 57). Rauch opposes (Paper 75); Ni replies (Paper 83). Since the contingency has not been met, we dismiss Ni motion 6 as moot.
VIII.

Rauch Motion 5 Contingent on the denial of Rauch motion 2 to add Rauch proposed count

2 to the interference, Rauch moves pursuant to 37 CFR § 41 .I21(a)(l), to

designate Ni '568 patent claims 7, 20, 33 and 46 as corresponding to Count 1 (Paper 48). Ni opposes (Paper 69); Rauch replies (Paper 88).
[47]

Ni '568 patent claim 7, written in independent form, reads: An isolated antibody or fragment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2, wherein said antibody or fragment thereof is an agonist of the protein of SEQ ID NO:2.

[48]

Ni '568 patent claim 20, written in independent form, reads: An isolate monoclonal antibody or fragment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2, wherein said antibody or fragment thereof is an agonist of the protein of SEQ ID NO:2. Amino acid residues 1 to 133 of SEQ ID NO:2 are said to represent the

extracellular domain of DR5 (FF 11).
[49]

Ni '568 patent claim 33, written in independent form, reads: An isolated antibody or fragment thereof that specifically binds to the extracellular domain of the protein encoded by the cDNA contained in ATCC Deposit No. 97920, wherein said antibody or fragment thereof is an agonist of the protein encoded by the cDNA contained in ATCC Deposit No. 97920.

[SO]

Ni '568 patent claim 46, written in independent form, reads: An isolated monoclonal antibody or fragment thereof that specifically binds to the extracellular domain of

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 26 of 74
Page 25 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lrnrnunex Corp. (Rauch)

the protein encoded by the cDNA contained in ATCC Deposit No. 97920, wherein said antibody or fragment thereof is an agonist of the protein encoded by the cDNA contained in ATCC Deposit No. 97920.
[51]

The amino acid sequence of the protein encoded by the cDNA contained in ATCC Deposit No. 97920 is purportedly the same as SEQ ID NO:2 in the '568 patent (NX 2004, col. 7,ll. 10-14).

[52]

According to the '568 patent specification, protein agonist antibodies "potentiate or activate either all or a subset of the biological activities of the ligand-mediated receptor activation," such as increasing DR5TTRAIL mediated apoptosis (NX 2004, col. 4, 11. 14-20; col. 64, 11. 18-21). Thus, the subject matter of Ni claims 7, 20, 33 and 46 is directed to

isolated antibodieslfragments which perform two functions. First, they specifically bind to the ECD (amino acid residues 1 to I 3 3 of SEQ ID NO:2) of TRAIL-binding receptor protein DR5. Second, as a result of binding the ECD of DR5, they either enhance at least one biological activity of DR5 that occurs as result of DR5 binding TRAIL or act as a "pseudo" TRAIL and activate at least one biological activity of DR5. "A claim corresponds to a count if the subject matter of the count, treated as prior art, to the claim, would have anticipated or rendered obvious the subject matter of the claim." 37 CFR §41.207(b)(2). Furthermore, there is a rebuttable presumption that a claim which is not designated as corresponding to the count is not directed to the same patentable invention as the count. Chiong v. Roland, 17 USPQ2d at 1544. Ni claims 7,20,33 and 46 have been designated as not corresponding to Count 1 (FF 11 and 20). In other words, the subject matter of

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 27 of 74
Page 26 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

Ni claims 7, 20, 33 and 46 presumably are not anticipated or rendered obvious by the subject matter of Count Iand it is Rauch's burden to show otherwise by an appropriate anticipation or obviousness analysis. Count 1 is defined in the alternative by Rauch '045 application claim 84 (FF 8). The "wherein" clause of claim 84 recites "wherein said antibodies or antigen-binding fragments specifically bind to membranes of Jurkat cells and also block binding of TRAIL ligand to said TRAIL-R receptor protein" (FF 15). Rauch argues that antibodies which block binding of TRAIL to TRAIL-R2 ("blocking antibodies") generically encompass TRAIL-R2 agonistic and antagonistic antibodies (Paper 48, p. 4). Rauch's entire anticipation and/or obviousness analysis is if used as prior art against Ni claims 7,20,33 or 46, Count I , which recites antibodies which "block binding of TRAIL ligand to said TRAIL-R receptor protein" and includes both antagonistic or agonistic antibodies to TR2, would render Ni claims 7, 20, 33, or 46, directed to an antibody or fragment thereof which "is an agonist of the protein of SEQ ID NO:2" unpatentable as anticipated and/or obvious. As such, Ni claims 7, 20, 33, and 46 should be designated as corresponding to Count 1. [Paper 48, p. 6 , T l . l Assuming arguendo that the "blocking antibodies" of Count 1 encompassed both agonistic and antagonistic antibodies and antigen-binding fragments thereof as alleged by Rauch, the subject matter of Count 1 as defined by Rauch '045 application claim 84 is generic to and, therefore, does not necessarily anticipate, the subject matter of any one of Ni claims 7, 20, 33 or 46. However, the analysis does not end there. Simply because a species falls within a genus disclosed by the prior art (here the subject matter of Count 1) does not

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 28 of 74
Page 27 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

necessarily make that species per se obvious. The genus and the species may be separately patentable. In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (rejecting Commissioner's argument that "regardless [ I how broad, a disclosure of a chemical genus renders obvious any species that happens to fall within it"). Moreover, here, there is a rebuttable presumption that the subject matter of Ni claims 7, 20, 33 and 46 are separately patentable from the allegedly generic "blocking antibodies" of Count 1. Rauch has not attempted to overcome that presumption in any meaningful way. Secondly, more than mere conclusory statements are required to reach a conclusion of obviousness. In re Kahn, 441 F.3d 977, 988, 78 ISPQ2d 1329, 1336 (Fed. Cir. 2006). The ultimate determination of whether an invention would have been obvious is a legal conclusion based on the evidence. RichardsonVicks Inc. v. Upjohn Co., 122 F.3d 1476, 1483,44 USPQ2d 1181, 1187 (Fed. Cir. 1997), including underlying factual inquiries such as ( I ) the scope and content of the prior art, (2) the level of ordinary skill in the art, (3) the differences between the claimed invention and the prior art, and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1,7-8, 148 USPQ 459, 467 (1969). Thus, the evaluation of obviousness is not made in a vacuum, but requires consideration of the pertinent prior art and the level of ordinary skill in the art. Therefore, Rauch must provide some evidentiary basis for considering the obviousness of the subject matter in light of the scope and content of the prior art, including the subject matter of Count 1, and the level of ordinary skill in

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 29 of 74
Page 28 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

the art. This might be done by testimony of a person familiar with the relevant art at the relevant time. Rauch cites to an article by Adams, RX 1037~, the proposition that "an for antibody that binds to a receptor and prevents ligand binding may also act as an agonist of receptor function" (Paper 48, pp. 4-5).
[53]

Adams describes "a chimeric mouse anti-human CD40 monoclonal antibody (Chi220) which both blocks CD154 binding and has partial agonist properties, potentially circumventing the thromboembolic complications associated with the inadvertent targeting of platelets during anti-CD154 therapy" (RX 1037, p. 543, first sentence). However, Rauch does not address the level of ordinary skill in the art or

what a skilled artisan would understand from the subject matter of Count 1 or Adams. For one thing, Adams and Count 1 are directed to two different ligandlreceptor pairs, CD154lCD40 and TRAILITRAIL-R2 and Adams' antibody is a chimeric antibody. It may be that one of ordinary skill in the art would have reasonably expected a "blocking antibody" to enhance or potentiate receptor protein activity by blocking ligand binding as found in the case of Adams' Chi220 chimeric antibody. Alternatively, it may be that one of ordinary skill in the art would not have reasonably expected a "blocking antibody" to enhance or potentiate receptor protein activity and that Adams' Chi220 chimeric antibody was a totally unexpected, unique antibody. Rauch might have cited to expert testimony to address these questions. Alternatively, Rauch might have
7

Adams et al. (Adams), "Development of a Chimeric Anti-CD40 Monoclonal Antibody That Synergizes with LEA29Y to Prolong Islet Allograft Survival," Journal of Immunology, vol. 174, pp. 542-550 (2005).

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 30 of 74
Page 29 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

introduced evidence that an expected percentage of antibodies that block cognate ligand from binding to its receptor protein agonize receptor protein's activity. In short, Rauch's arguments cannot substitute for factual evidence sufficient to support a conclusion of obviousness. Based on the foregoing, Rauch motion 5 is denied. IX.

Rauch Motion 3
Pursuant to 37 CFR § 41.121(a)(l)(ii), Rauch moves to be accorded

benefit for the purpose of priority of the filing dates of five specified priority applications for the subject matter of Count 1 and, contingent upon the grant of Rauch motion 2, for the subject matter of Rauch proposed count 1 (Paper 46). Ni opposes (Paper 67); Rauch replies (Paper 86). In view of our denying Rauch motion 2 to the extent it sought to substitute Rauch proposed count 1 for current Count 1, Rauch motion 3 is dismissed as moot since the contingency has not been met. Therefore, we address Rauch motion 3 as it relates to Count 1.
[54]

Rauch's involved '045 application was not accorded benefit for the purpose of priority of any earlier filed application when the interference was declared.

[55]

Rauch's involved '045 application is said to be (1) a continuation-in-part of application 081833,036 ("the '036

application," RX 1018), filed 26 June 1997, which is said to be (2) a continuation-in-part of application 081869,852 ("the '852

application," RX 1017), filed 4 June 1997, which is said to be

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 31 of 74
Page 30 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

(3)

a continuation-in-part of application 081829,536 ("the '536

application," RX 1016), filed 28 March 1997, which is said to be (4) a continuation-in-part of application 081815,255 ("the '255

application," RX 1015), filed 12 March 1997, which is said to be (5) a continuation-in-part of application 081799,861 ("the '861

1 application," RX 1014), filed 13 February 1997 (RX 1004, p. 1, 1. 10-16). Rauch seeks benefit for the purpose of priority of the filing dates of each of the '036, '852, '536, '255 and '861 applications as to the subject matter of Count 1 (Paper 46, p. 1, TI). Ni requests that Rauch motion 3 be denied with respect to the filing dates of the '255 and '861 applications (Paper 67, p. 1, 71). A party is entitled to benefit for the purpose of priority of its earliest constructive reduction to practice. Earliest constructive reduction to practice "means the first constructive reduction to practice that has been continuously disclosed through a chain of patent applications including the involved application or patent." 37 CFR 5 41.201. Here, Rauch seeks benefit of the filing date of the '861 application as its earliest constructive reduction to practice of the subject matter of Count 1. Thus, Rauch must establish that each application in the priority chain describes an enabled embodiment within the scope of Count 1 that was carried forward from its immediate parent application. As noted above (FF 47), each application in Rauch's priority chain is a continuation-in-part of its immediate parent application and, therefore, presumptively includes subject matter different from its respective immediate parent application. Thus, if any immediate parent fails to provide a constructive reduction to practice of the

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 32 of 74
Page 31 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

subject matter of Count 1 which was carried forward into its respective child application, the chain is broken and we do not reach any earlier application. Rauch has provided an Appendix for each of the '861, '255, '536, '852 and '036 applications particularly pointing out the disclosure in each application being relied upon as describing an enabled embodiment within the scope of Count 1 (Paper 46, Appendices C-G, pp. 36-96). The subject matter of Count 1 is defined in one alternative by the claim 84 of Rauch's involved '045 application (FF 8). Claim 84 of the '945 application is directed to a composition comprising isolated antibodies or binding fragments thereof ("antibodieslfragments") which specifically bind to a defined antigen, a TRAIL-R2 receptor protein characterized as binding TRAIL, having a molecular weight of about 50 to 55 kD, comprising the amino acid sequence VPANEGD, and as being obtained from Jurkat cell membranes by a defined method, wherein the antibodieslfragments specifically bind Jurkat cell membranes and block binding of ligand to TRAIL-R2 receptor protein (FF 15-16).

A.
[56]

The '036 application (RX 1018)

Example 1 of the '036 specification is said to describe isolating and purifying a human TRAIL-R2 receptor protein having a molecular weight of about 52 kD from the membranes of Jurkat cells using the same method steps recited in claim 84 of the '045 application (RX 1018, p. 4, 11. 9-12; p. 31, 1. 7 - p. 32, 1. 35).

[57]

Example 2 of the '036 specification is said to describe a tryptic fragment of the TRAIL-R2 protein of Example 1 obtained from Jurkat cell membranes

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 33 of 74
Page 32 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

as having the amino acid sequence VPANEGD (i.e., amino acids 327-333 of SEQ ID NO:2 of the '045 application) (RX 1018, p. 2, 11. 23-25; p. 33, 11.

[58]

SEQ ID NO:2 of the '036 specification is said to be the amino acid sequence encoded by a full length human TRAIL-R2 protein cDNA obtained from human foreskin fibroblasts (RX 1018, p. 3, 1. 10-14; p. 36, 11. 1 1-36) and discloses the same 440 amino acid TRAIL-R2 sequence designated as SEQ ID NO:2 in the '045 application.

[59]

According to the '036 specification, antibodies or fragments thereof that specifically bind TRAIL-R2 may be obtained by conventional techniques (RX 1018, p. 26, 1. 25 - p. 27, 1. 21).

[60]

Example 4 of the '036 specification is said to describe using conventional monoclonal antibody techniques and purified TRAIL-R2 immunogens to obtain monoclonal antibodies that specifically bind to TRAIL-R2 (RX 1018,

[61]

According to Example 4 of the '036 specification, antibodies that bind TRAIL-R2 may be detected by dot blot assay, enzyme-linked immunosorbent assay or inhibition of TRAIL binding (RX 1018, p. 35, 11. 5-

[62]

Further according to the '036 specification antibodies that additionally can block binding of TRAIL-R to TRAIL may be used to inhibit a biological activity that results from such binding. Such blocking antibodies may be identified using any suitable assay procedure, such as by testing antibodies for the ability to inhibit binding of TRAIL to cells expressing TRAILR[2]. Examples of such cells are the Jurkat cells and

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 34 of 74
Page 33 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

PSI cells described in example 2 below. Alternatively, blocking antibodies may be identified in assays for the ability to inhibit a biological effect that results from the binding of TRAIL to target cells. Antibodies may be assayed for the ability to inhibit TRAIL-mediated lysis of Jurkat cells, for example. [RX 1018, p. 27, 11. 25-33, bracketed text added.]
[63]

Thus, the '036 specification describes an enabled embodiment within the scope of Count 1, i.e., isolated antibodieslfragments that specifically bind to Jurkat cell membranes and block binding of TRAIL ligand to a TRAILR2 protein, wherein the TRAIL-R2 protein is characterized as binding TRAIL, having a molecular weight of about 50 to 55 kD, comprising the amino acid sequence VPANEGD, and obtained from Jurkat cell membranes using method steps as recited in claim 84 of the '045 application (FF 56-63).

[64]

Ni does not dispute Rauch's claim to benefit for the purpose of priority of the filing date of the '036 application for the subject matter of Count 1 (Paper 67, p. 1, TI). Based on the foregoing and the evidence submitted by Rauch in support

of its motion, we accord Rauch benefit for the purpose of priority of the 26 June 1997 filing date of its '036 application (RX 1018) as to the subject matter of Count 1 as defined by claim 84 of the '045 application. It is unnecessary to address whether the '036 application also provides a constructive reduction to practice of the alternative definition of Count 1.

B.

The '852 application (RX 1017)

[65] Example 1 of the '852 specification is said to describe isolating and

purifying human TRAIL-R2 receptor protein having a molecular weight of

Case 1:07-cv-00780-SLR

Document 10-4

Filed 01/16/2008

Page 35 of 74
Page 34 Paper 133

Interference No. 105,240 Human Genome Sciences, Inc. (Ni) v. lmmunex Corp. (Rauch)

about 52 kD from the membranes of Jurkat cells using the same method steps recited in claim 84 of the '045 application (RX 1017, p. 4, 11. 11-12; p. 30, 1. 1 - p. 31, 1. 16).
[66]

Example 2 of the '852 specification is said to describe a tryptic fragment of the TRAIL-R2 protein of Example 1 isolated from Jurkat cell membranes as having the amino acid sequ