Noelle v. Lederman

The opinion in support of the decision being
entered today is not binding precedent of the Board.
Paper No. 135
Filed by: Trial Section Motions Panel
Box Interference Filed: 19 October 2001
Washington, D.C. 20231
Tel: 703-308-9797
Fax: 703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
________________________
BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
________________________
RANDOLPH NOELLE
(08/742,480),
Junior Party,
v.
SETH LEDERMAN, LEONARD CHESS,
and MICHAEL J. YELLIN
(5,474,771),
Senior Party.
________________
Patent Interference No. 104,415
_________________
Before: TORCZON, GARDNER-LANE and TIERNEY, Administrative Patent Judges.
TIERNEY, Administrative Patent Judge.
FINAL DECISION
(Decision on Lederman Preliminary Motion 8)
This interference is before a motions panel for a decision on preliminary motions. Oral
argument took place on September 26, 2001. Representing Junior Party Noelle at oral argument
was E. Anthony Figg and Robin L. Teskin. Senior Party Lederman was represented by James F.
Haley, Jr., Margaret A. Pierri, Jane Gunnison and Stanley D. Liang. A transcript of the oral
argument appears in the record. (Paper No. 134).

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TABLE OF CONTENTS
I. Summary of the Opinion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
II. Previous Decisions in the Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
III. Findings of Fact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
A. Previous Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
B. Additional Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
IV. Lederman Preliminary Motion 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
A. No Interference-In-Fact is a One-Way Distinctiveness Test . . . . . . . . . . . . . . . . . 9
1. Anticipation is Not an Issue in this Interference . . . . . . . . . . . . . . . . . . . 10
2. Obviousness Requires Both Motivation and Reasonable Expectation of
Success . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
a. Motivation is Not an Issue in this Interference . . . . . . . . . . . . . . 11
b. Reasonable Expectation of Success . . . . . . . . . . . . . . . . . . . . . . . 11
i. Noelle  s Reliance on the Parties  Specifications is
Misplaced . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ii. Prior Art Immunization Techniques Conventional But
Lacked Reasonable Expectation of Success . . . . . . . . . . 17
iii. Prior Art Construction of CD40-Ig Fusion Protein Lacked
Reasonable Expectation of Success . . . . . . . . . . . . . . . . . 21
iv. Prior Art Expression Cloning Techniques Lacked
Reasonable Expectation of Success . . . . . . . . . . . . . . . . . 22
3. Lederman  s 	 Human  Claims Would Not Render Obvious
Noelle  s 	 Mouse  Claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4. Dispute over Structural and Functional Obviousness . . . . . . . . . 25

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V. Decision on Deferred Motions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
VI. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
VII. Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Interference No. 104,415
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I. Summary of the Opinion
This is an interference between Junior Party Noelle (real party in interest, IDEC
Pharmaceuticals, Inc.) and Senior Party Lederman (real party in interest, Biogen, Inc.). The sole
issue before this panel is the question of whether or not there exists an  interference-in-fact 
between Noelle  s remaining patentable claims and Lederman  s claims. More particularly, there
is a dispute as to whether, at the relevant time, a person of ordinary skill in the art having either
the anti-mouse or anti-human CD40 counter-receptor antibodies would have had a reasonable
expectation of success of obtaining the other.
Noelle has demonstrated that one skilled in the art, given the anti-mouse or anti-human
antibodies, would have expected its human or mouse counterpart to exist. Moreover, Noelle has
sufficiently demonstrated that screening techniques for antibodies were well known in the art at
the relevant date. Nevertheless, Lederman has demonstrated that one skilled in the art, provided
with Noelle  s 	 mouse  claims and the prior art, would not have had a reasonable expectation of
success of obtaining the anti-human antibodies. Accordingly, we hold that Lederman has
sufficiently established that its  human  claims are not obvious or anticipated by Noelle  s
mouse  claims. As such, no interference-in-fact exists between Noelle  s remaining patentable
claims and Lederman  s claims.
II. Previous Decisions in the Interference
As set forth in the Memorandum, Opinion and Order (  Memorandum,  Paper No. 108),
this interference concerns CD40 counter-receptors for the CD40 B-cell antigen and monoclonal

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1 The interference was declared on September 3, 1999, (Paper No. 1), with Count 1
which reads as follows:
The monoclonal antibody of claim 1 of 5,474,771 [Lederman] or the
monoclonal antibody of claim 42 or claim 51 of 08/742,480 [Noelle].
(Paper No. 1, p. 46). Claim 1 of Lederman  771 is directed to a monoclonal antibody that
specifically binds and forms a complex with a 5c8 antigen (  CD40CR  )(  human 	 embodiment)
whereas claim 42 of Noelle is directed to a monoclonal antibody or fragment thereof which
specifically binds a mouse CD40CR (  mouse  embodiment) and Noelle claim 51 is directed to a
monoclonal antibody or fragment thereof that specifically binds CD40CR (  genus 
embodiment). (See, Paper No. 108, facts 4-7).
antibodies for these CD40 counter-receptors. CD40 counter-receptors are expressed on activated
T cells and are also known as CD40CRs or CD40Ls.
This interference was declared with a single count having three alternative embodiments.1
To simplify the terminology in this interference, the first alternative can be generally referred to
as the  human  antibody to human CD40CR, the second alternative as  mouse  antibody to
mouse CD40CR and the third alternative as the  genus  of antibodies to CD40CRs. Noelle  s
involved application had claims directed to all three alternative embodiments whereas
Lederman  s involved patent presents claims directed to only the 	 human  embodiment.
For each of its three claimed embodiments, Noelle sought 35 U.S.C. § 120 benefit of U.S.
Application No. 08/338,975, filed November 14, 1994, as well as U.S. Application No.
07/835,799, filed February 14, 1992. During the course of the interference, it was determined
that Noelle  s 	 genus  and  human  embodiments lacked written descriptive support in Noelle  s
799 application as of the February 14, 1992 filing date. (Paper No. 108, pages 23-33). Lacking
benefit of its 1992 filing date, an Administrative Patent Judge became aware of reasons why
Noelle  s 	 genus  and  human  claims were unpatentable under 35 U.S.C. § 102(b).

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2Lederman filed a revised Lederman Preliminary Motion 8 (Paper No. 116) to correct
what it termed  typographical  errors in its originally filed Lederman Preliminary Motion 8
(Paper No. 113). Lederman  s revised motion was entered into the record. Accordingly, this
opinion refers to the revised Lederman Preliminary Motion 8 (Paper No. 116) as  Lederman
Preliminary Motion 8. 
Accordingly, the Judge issued an Order under 37 CFR § 1.641 rejecting Noelle  s 	 genus  and
human  claims as anticipated by the disclosures of Lederman WO 93/09812 and/or Armitage
WO 93/08207. (Paper No. 109). Although reserving the right to appeal, Noelle did not contest
the finding that Noelle  s 	 genus  and  human  claims lacked written descriptive support as of
the February 14, 1992 filing date and did not contest the unpatentability of these claims under 35
U.S.C. §102(b). (Lederman Preliminary Motion 8, Paper No. 116, pages 2-3, facts 4, 5, Noelle
Opposition 8, Paper No. 118, p. 3, admitted facts 4 and 5).2
Lederman Preliminary Motions 6 and 7 sought to redefine the interfering subject matter.
As noted during the oral argument of April 12, 2001, Lederman  s motions were defective.
Specifically, Lederman proposed counts that did not correspond to any of Lederman claims. Yet,
as apparent from the motions and as noted at the oral argument of April 12, 2001, for all practical
purposes Lederman Preliminary Motions 6 and 7 requested a finding of no interference-in-fact.
(Order, Paper No. 109, pages 10-12).
Our Memorandum (Paper No. 108) deferred resolution of Lederman Preliminary Motions
6 and 7 as they were contingent upon Lederman  s prior art patentability motions 1 and 2, which
were deferred. As we determined that Noelle  s 	 human  and  genus  claims were unpatentable
to Noelle, the issue of no interference-in-fact was ripe for consideration. Counsel for both Noelle
and Lederman agreed to rebrief the issue of no interference-in-fact. Specifically, times were set

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3Noelle Miscellaneous Motion 1 noted that Noelle Exhibits NX 2085 and 2087 were
already in evidence as Lederman Exhibits LX 1052 and 1095, respectively. (Paper No. 125, p.
2).
for Lederman to withdraw its motions 6 and 7 and to file a new motion, Lederman Preliminary
Motion 8, to correct the procedural defects noted in Lederman Preliminary Motions 6 and 7.
Likewise, times were set to allow for Noelle to oppose this motion and for Lederman to reply to
Noelle  s opposition. (Order Setting Times, Paper No. 111, Order Setting Times, Paper No. 117,
and Decision on Miscellaneous Motion, Paper No. 127).
In response to Lederman Preliminary Motion 8, Noelle has filed Noelle Opposition 8
(Paper No. 118) which identifies and relies upon exhibits 2084-2095, as well as earlier-filed
exhibits. In the Order Setting Times (Paper No. 111) and in the Communication of September
10, 2001 (Paper No. 122), the parties were informed that a party wishing to submit new evidence
in this interference was to submit a miscellaneous motion under 37 CFR § 1.635, which was to
show good cause as to why the new evidence could not have been previously presented in the
interference. Seeking to have the new evidence entered into the record, Noelle filed Noelle
Miscellaneous Motion 1 (Paper No. 125) which, inter alia, requested: 1) entry of Noelle exhibits
NX 2086, 2088, 2089, 2090-2091; and 2) withdrawal of Noelle exhibits NX 2084 and 2092-
2095. (Paper No. 125, p. 2). As set forth in the Decision on Miscellaneous Motion (Paper No.
127), Noelle Exhibits NX 2086, 2088, 2090 and 2091 were entered into the record whereas
Noelle Exhibits NX 2084, NX 2089 and NX 2092-2095 were not entered into the record.3

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III. Findings of Fact
A. Previous Findings
We reaffirm our previous findings of fact and conclusions of law made in this
interference. As background information on the issue of reasonable expectation of success, we
reiterate findings of fact 32, 33, 35 and 36 from our Memorandum, Paper No. 108:
Fact 32. As of February 14, 1992, the isolation and purification of CD40 counter
receptors (  CD40CR  ) was not a predictable art. As of this date, the
skilled artisan could not have predicted with any reasonable degree of
certainty from Noelle  s disclosure whether particular CD40CRs and the
antibodies specific to the CD40CRs could be generated and isolated other
than Noelle  s disclosed mouse CD40CR and the antibodies specific to the
mouse CD40CR. Indeed, it would have been difficult for the skilled
artisan to generate and isolate the CD40CRs and antibodies specific to the
CD40CRs beyond those disclosed by Noelle  s application. (See generally,
LX 1006, LX1007, LX 1092 and LX 1093).
Fact 33. As of February 14, 1992, the construction of CD40-Ig fusion protein, such
as Noelle  s CD40-Ig, would have been extremely difficult. (LX 1092,
¶ 16, LX1093, ¶ 10). During the prosecution history of Noelle  s parent
U.S. Application No. 07/835,799, Dr. Sandro Aruffo submitted a
declaration stating that:
Prior to the actual construction of the CD40-
immunoglobin fusion protein disclosed and claimed
in the above-identified patent application
[07/835,799], I and my co-inventors could not
predict whether this approach would result in a
biologically active fusion protein.
(Declaration of Aruffo under 37 C.F.R. 1.132 dated July 7, 1994, LX
1009, p. 2). Dr. Aruffo further stated that:
[E]ach individual fusion protein must be
constructed independently, and whether a particular
fusion protein can be successfully generated is often
not determinable until the experiment is performed.
In view of this lack of predictability, there is not a
reasonable expectation of success prior to the actual

Interference No. 104,415
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production of a recombinant immunoglobin fusion
molecule.
(Declaration of Aruffo under 37 C.F.R. 1.132 dated July 7, 1994, LX
1009, p. 3).
Fact 35. One skilled in the art reviewing the Noelle  480 application would have
doubts regarding the validity of Section 7 [which discusses the binding of
a CD40Ig fusion protein to human T-cell lines]. Specifically, a control
should have been included in Section 7 to confirm that the reported
binding is due to the CD40 moiety, rather than the Ig moiety, of the CD40-
Ig fusion protein. (LX1007, ¶ 39, LX 1006, ¶ 30). Absent the proper
control, one skilled in the art could not have known whether the CD40-Ig
fusion protein was binding to a cell surface protein on Jurkat and HSB2
cells via the CD40 portion of the CD40-Ig molecule. (LX1007, ¶ 39, LX
1006, ¶ 30). At best, Noelle  s expert, Dr. Clark, states that:
In my opinion, it is more plausible than not to
assume that the results in Section 7 and Figure 7
are valid, e.g., attributable to the CD40 portion of
the fusion protein as the Noelle application
describes several other experiments (described in
Section 6.2.3 of Noelle Application), wherein an
appropriate control, i.e., CD7E-Ig was utilized and
confirmed that the observed binding of the CD40-Ig
to activated mouse T helper cells and CD40, and not
the Ig moiety of the fusion protein.
(NX 2012, ¶ 14, emphasis added).
Fact 36. As of February 14, 1992, it would have been difficult for one of ordinary
skill in the art to conduct the expression cloning methodology recited in
the Noelle  480 application. (Amendment and Response filed October 1,
1993 in support of Armitage, U.S. Application No. 07/969,703, LX 1083,
p. 7, LX 1092, ¶ 45 on p. 17, LX 1093, ¶ 33).
B. Additional Findings
We make the following additional findings of fact:
37. The claims of the parties are as follows:

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4Noelle originally cited claim 58 as a pending claim. (Noelle  s Clean Copy of Pending
Claims, Paper No. 7). Claim 58, however, was cancelled by Examiner  s Amendment during the
prosecution of the  480 application. (Noelle Clarification of Status of Claim 58, Paper No. 45,
480 Prosecution History, Examiner  s Amendment, Paper No. 10, mailed August 12, 1998).
(i) The claims of the parties were:
Noelle  480 : 42, 43, 45-48, 50-57, 59 and 604
Lederman  771: 1-14
(ii) The claims of the parties which corresponded to Count 1 were:
Noelle  480 : 42, 43, 46-48, 50-54, 56, 57, 59 and 60
Lederman  771: 1-7 and 10-13
(iii) The claims of the parties which did not correspond to Count 1 are:
Noelle  480 : 45 and 55
Lederman  771: 8, 9 and 14
(Paper No. 1, p. 46). Noelle claims 51, 52, 53, 56, 59 and 60 are directed to the  genus  and
human  embodiment of Count 1. These claims have been determined unpatentable to Noelle.
Accordingly, Noelle  s corresponding claims are 42, 43, 46-48, 50, 54, and 57.
38. At the relevant time, one skilled in the art believed that the induction of B lymphocyte
responses was a complex process. Specifically, one skilled in the art believed:
The induction of B lymphocyte responses is a complex process that is initiated
and regulated by T lymphocytes. T cells effect B cell responses via direct cell-cell
contact or by means of soluble cytokines. Although early studies focused on the
role of surface Ig in the activation of B cells, more recent studies have suggested
that surface Ig facilitates the capacity of B cells to take up specific Ag and present
it to T cells in a MHC-restricted manner, but may not otherwise be involved in T
cell-B cell collaboration. The precise mechanisms by which T cells stimulate B
cells remains unclear.

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(LX 1095, p. 2544, right col., lines 8-18, emphasis added).
39. At the relevant time, one skilled in the art understood that:
[A] variety of receptor ligand interactions appeared to be involved in the
collaboration with activated T cells inducing B cell proliferation and
differentiation.
(LX 1095, p. 2545, left col., lines 7-10).
40. Prior to the earliest application filing dates of Lederman and Noelle, it was known that
both human and mouse B cells expressed CD40, an antigen involved in B cell differentiation.
(LX 1079, p. 35, last ¶, Paper No. 118, p. 5, fact 32, Paper No. 129, p. 1, admitting fact 32).
41. In April 1991, i.e., prior to the earliest application filing dates of both Lederman and
Noelle, Lederman published an abstract (Lederman et al., Clin. Res. 39(2):380A, April 1991, NX
2086) regarding the mechanism of inducing B cell differentiation by a CD4- Jurkat clone,
identified as Jurkat clone (D1.1). This abstract  suggested  that molecular features on the D1.1
human T cell line, other than a lack of CD4, accounted for a constitutive ability to induce B cell
activation. (NX 2086, page 380A, last line).
42. At the relevant time, the known existence of the mouse CD40CR and the general
conservation in function of immune cell molecules across species would have suggested the
existence of the corresponding human CD40CR. (See generally, NX 2012, ¶¶ 17, 18).

Interference No. 104,415
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43. One skilled in the art studying B cell responses, at the relevant time, would have found it
difficult to extrapolate the results obtained from anti-mouse CD40CR antibodies to anti-human
CD40CR antibodies. Specifically:
[D]ifferences between the regulation of human and murine B cells
make it additionally difficult to extrapolate the results obtained
from one system to another.
(LX 1095, p. 2544, right col., lines 39-42).
44. Immunization with activated human T cells or activated or non-activated cell lines, such
as Jurkat and HSB2, would raise a number of known and unknown T cell proteins such as CD4,
OX40 receptor, CD25, MHC class II and ICAM-1. (LX 1093, Second Kelsoe Declaration, ¶ 26).
IV. Lederman Preliminary Motion 8
Lederman Preliminary Motion 8 moves for judgment, and termination of this interference
on the grounds that there is no interference-in-fact between Lederman  s 	 human  claims and
Noelle  s 	 mouse  claims. (Lederman Preliminary Motion 8, Paper No. 116, p. 1). Noelle
opposes this motion.
A. No Interference-In-Fact is a One-Way Distinctiveness Test
The question of whether there is no interference-in-fact is a one-way distinctiveness test.
Specifically, a movant can establish that no interference-in-fact exists by showing that its claimed

Interference No. 104,415
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5Example 20. Application AD contains patentable claim 1 (6-cylinder engine).
Application AE contains patentable claim 3 (8-cylinder engine). An interference is declared with
a single count (6 or 8-cylinder engine). Claim 1 of application AD and claim 3 of application AE
are designated to correspond to the count. Applicant AD believes that a 6-cylinder engine is a
separate patentable invention  (See § 1.601(n)) from an 8-cylinder engine. Applicant AD
would file a motion under § 1.633(b) for judgment on the ground of no interference-in-fact
stating why a 6-cylinder engine is patentably distinct from an 8-cylinder engine. If the Board
ultimately agrees with Applicant AD, a patent could issue to AD containing claim 1 of
application AD and a second patent could issue to AE containing claim 3 of application AE.
invention is patentably distinct from the opponents claimed invention. See Example 205, Notice
of Final Rule, Patent Interference Proceedings, 49 Fed. Reg. 48416, 48424 (col. 1) (Dec. 12,
1984). Thus, for Lederman to succeed in its motion for no interference-in-fact, Lederman need
only demonstrate that: (i) Lederman  s claims are not anticipated or rendered obvious by Noelle  s
remaining  mouse  claims; or (ii) Noelle  s remaining 	 mouse  claims are not anticipated or
rendered obvious by Lederman  s claims.

Anticipation is Not an Issue in this Interference
Both Noelle and Lederman agree that their corresponding claims, read in light of the prior
art, do not anticipate each others claims. (Noelle Opposition 8, Paper No. 118, p. 21, Lederman
Reply 8, Paper No. 129, p. 4).
Obviousness Requires Both Motivation and Reasonable Expectation of
Success
As to obviousness, both parties agree that a proper analysis under § 103 requires, inter
alia, consideration of two factors: (i) whether the prior art would have suggested to those of
ordinary skill in the art that they should make the claimed subject matter; and (ii) whether the

Interference No. 104,415
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prior art would also have revealed that in making the claimed subject matter, those of ordinary
skill would have a reasonable expectation of success. In re Vaeck, 947 F.2d 488, 493, 20
USPQ2d 1438, 1442 (Fed. Cir. 1991); In re Dow Chem., 837 F.2d 469, 473, 5 USPQ2d 1529,
1531 (Fed. Cir. 1988).
a. Motivation is Not an Issue in this Interference
The parties agree that, at the relevant date, the skilled worker having anti-human
CD40CR antibodies or anti-mouse CD40CR antibodies would have been motivated to obtain the
other. (Noelle Opposition 8, Paper No. 118, p. 21, Lederman Reply 8, Paper No. 129, p. 4).
b. Reasonable Expectation of Success
The parties disagree as to whether or not a reasonable expectation of success existed at
the relevant date. Specifically, the parties disagree as to whether a person of ordinary skill in the
art having either the anti-mouse or anti-human CD40CR antibodies would have had a reasonable
expectation of success of obtaining the other.
A reasonable expectation of success is not a requirement of absolute predictability. Only
a reasonable expectation that the beneficial result will be achieved is necessary to show
obviousness. Brown & Williamson Tobacco Corp. v. Philip Morris, Inc., 229 F.3d 1120, 1125,
56 USPQ2d 1456, 1459 (Fed. Cir. 2000); In re Longi, 759 F.2d 887, 897, 225 USPQ 645, 651
(Fed. Cir. 1985). A critical step in analyzing these expectations is casting the mind back to the
time of invention, to consider the thinking of one of ordinary skill in the art, guided only by the

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prior art references and the then-accepted wisdom in the field. In re Kotzab, 217 F.3d 1365,
1369, 55 USPQ2d 1313, 1316 (Fed. Cir. 2000).
Both parties have predominantly addressed their arguments and evidence to the issue of
whether Noelle  s claimed anti-mouse CD40CR antibodies would, in light of the prior art, have
provided a reasonable expectation of success of obtaining Lederman  s claimed anti-human
CD40CR antibodies. Noelle justifies this focus by noting that its alleged prior art screening
methodology works in either direction, i.e., mouse to human or human to mouse. (Transcript of
Sept. 26, 2001 Oral Argument, Paper No. 134, p. 52, lines 1-10). As the parties have focused on
the expectation of success for obtaining Lederman  s claimed anti-human CD40CR antibodies,
we adopt a similar focus.
Lederman argues that, as of the relevant date, there would not have been a reasonable
expectation of success of obtaining a monoclonal antibody specific to human CD40CR antigen
using a monoclonal antibody specific to mouse CD40CR antigen. (Paper No. 116, pages 16-17).
Lederman further alleges that there were no processes available at that time for obtaining an anti-
human CD40CR monoclonal antibody or its antigen with a reasonable expectation of success.
(Paper No. 116, pages 17-19). Noelle disagrees.
According to Noelle,  the parties [sic] disclosures, coupled with the high level of skill in
the art at the time, provided a reasonable expectation of success in making monoclonal
antibodies to both the murine and human CD40CR antigens.  (Paper No. 118, p. 3). Indeed,
Noelle  s expert, Dr. Edward Clark, has testified that Noelle  s  480 application provided at least
three different methods for making anti-CD40CR antibodies. (Declaration of Edward A. Clark,

Interference No. 104,415
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NX 2012, p. 23, ¶ 30). Generally, the three methods mentioned by Dr. Clark are:
1) Immunization of a host with CD40CR expressing cells or cell line and selection of
anti-CD40CR antibody by functional or competition binding with CD40Ig fusion
protein;
2) Isolation of CD40CR by Affinity Purification using CD40Ig to precipitate at least
human and mouse CD40CRs; and
3) Use MR1 monoclonal antibody or CD40Ig fusion to clone CD40CR DNA and use
expression product to produce anti-CD40CR antibody.
(NX 2012, pages 23-33, ¶¶ 30-47). Noelle  s opposition appears to focus upon an alleged
reasonable expectation of success for the first method, immunization and screening, and the
second method, using CD40Ig to co-precipitate its human counterpart ligand, human CD40CR.
Noelle  s opposition argues that one skilled in the art had a reasonable expectation of
success of obtaining Lederman  s claimed anti-human CD40CR antibodies using immunization
techniques, Dr. Clark  s 	 first  method, or a precipitation technique involving a soluble CD40Ig
protein, Dr. Clark  s 	 second  method. Specifically, Noelle  s opposition alleges that monoclonal
antibodies to human CD40CR could be produced without undue experimentation since it was
expected that CD40CR was expressed on activated human T-cells and:
Also, it would be obvious to produce a population of hybridomas secreting
monoclonal antibodies to activated human T-cell surface antigens and screen to
identify those which express antibodies specific to CD40CR using known and
available techniques. For example, a skilled person would have screened the
hybridomas to identify monoclonal antibodies that block T-cell activation of B-
cells. (NX 2012, ¶39). Such screening would not rise to the level of invention.
The Federal Circuit has held particularly that routine screening of large
populations of hybridomas does not constitute undue experimentation. In re
Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed Cir. 1988).
The Noelle application teaches that monoclonal antibodies that specifically
bind human CD40CR and T cells which express human CD40CR could be

Interference No. 104,415
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6We commend both parties for the concise and informative visual aids that were provided
at the oral argument of September 26, 2001.
identified by use of the hCD40Ig fusion protein as a screen. On [sic] of ordinary
skill would reasonably expect anti-human CD40CR antibodies to compete with
soluble CD40Ig for binding to activated human Th cells, and immunoprecipitate
the same protein expressed on activated human Th cells.
(Paper No. 118, pages 14-15).
During the oral argument of Sept. 26, 2001, Noelle appears to have moved away from its
reliance on the teachings of its own specification. During the oral argument Noelle relied more
upon a combination of allegedly conventional immunization and screening techniques. For
instance, at oral argument, Noelle took the position that one skilled in the art had a reasonable
expectation of success of obtaining the anti-human antibodies by a combination of: (1) activating
T-cells; (2) immunizing a mouse with activated mouse or human Th-cells and preparing
hybridomas that produce the resulting antibodies; (3) conducting a  +/- screening  using
activated and resting T-cells; and, (4) conducting functional screening. (See, Paper No. 133,
Noelle Hearing Visual Aids, Tabs 1-6). Noelle also argued that one skilled in the art could
immunoprecipitate the human CD40CR using CD40Ig. (See, Paper No. 133, Noelle Hearing
Visual Aids, Tab 7).6 Noelle  s alleged expectation of success for the three methods said to be
disclosed by the Noelle application as well as the methods specifically identified in Noelle  s
opposition and those identified at oral argument are discussed below.
i. Noelle  s Reliance on the Parties  Specifications is
Misplaced
At the outset, we note that Noelle  s opposition relies extensively on the disclosures of the

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Noelle and Lederman applications to provide one skilled in the art with a reasonable expectation
of success of obtaining Lederman  s claimed subject matter. For example, Noelle states:
The parties  disclosures, coupled with the high level of skill in the art at the time,
provided a reasonable expectation of success in making monoclonal antibodies to
both the murine and human CD40CR antigens.
(Paper No. 118, p. 3). The parties  specifications, however, are not available as 	 prior art  for
determining whether an interference-in-fact exists.
An interference-in-fact exists when:
An interference-in-fact exists when at least one claim of a party that is designated
to correspond to a count and at least one claim of an opponent that is designated to
correspond to the count define the same patentable invention.
37 CFR § 1.601(j)(emphasis in original). The test for whether claims define the same or separate
patentable inventions is as follows:
Invention "A" is the same patentable invention as an invention "B" when
invention "A" is the same as (35 U.S.C. 102) or is obvious (35 U.S.C. 103) in
view of invention "B" assuming invention "B" is prior art with respect to
invention "A". Invention "A" is a separate patentable invention with respect to
invention "B" when invention "A" is new (35 U.S.C. 102) and non-obvious (35
U.S.C. 103) in view of invention "B" assuming invention "B" is prior art with
respect to invention "A".
37 CFR § 1.601(n)(emphasis in original). Thus, interference-in-fact questions require an analysis
of whether or not a parties corresponding claims anticipate or render obvious the opposing
parties corresponding claims.
In determining whether an invention is a  separate  patentable invention, the parties
specifications underlying the respective corresponding claims are not considered  prior art.  The

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specifications, however, could be relied upon to serve as a dictionary for the terms appearing in
the claims or for admissions against interest regarding prior art.
Noelle  s reliance on the parties specifications is misplaced. Specifically, Noelle has
attempted to rely on the parties  disclosures as evidence that the claimed monoclonal antibodies
could be produced without undue experimentation. For example, Noelle states that:
[B]oth the Noelle and Lederman application [sic] similarly teach reproducible
methods for producing monoclonal antibodies against an antigen (CD40CR)
expressed by activated T cells and selecting appropriate (anti-CD40CR)
monoclonal antibodies from the population of monoclonal antibodies obtained
based on function or binding characteristics (inhibition of contact-dependent T/B
cell activation, binding to an antigen expressed by activated T cells involved in B
cell activation and/or competition with soluble human CD40-Ig for binding to
activated T cells.) The Noelle application provides a reagent, soluble human
CD40Ig, that was a powerful tool for the identification of human CD40CR-
expressing T cells for making monoclonal antibodies against human CD40CR or
to affinity purify human CD40CR with a reasonable expectation of success.
(Paper No. 118, p. 18, lines 10-13, emphasis added). The parties corresponding claims are
directed to: (i) monoclonal antibodies or fragments thereof; (ii) cell lines producing the
antibodies and; (iii) pharmaceutical or diagnostic compositions containing the antibodies or
fragments thereof. The corresponding claims are not directed to particular methods for
producing monoclonal antibodies or to Noelle  s CD40Ig fusion protein. As such, Noelle  s
opposition does not rely upon the parties  specifications to define the terms of the corresponding
claims, but rather, Noelle relies upon the specifications as  prior art  references without showing
how the specifications are admissions of, or references to, prior art. Accordingly, we discount
those portions of Noelle  s opposition that rely upon the parties  specification as evidence of an
expectation of success.

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ii. Prior Art Immunization Techniques Conventional But
Lacked Reasonable Expectation of Success
According to Lederman, immunization techniques, such as those described in Noelle  s
application, would not have provided a reasonable expectation of obtaining a monoclonal
antibody specific to human CD40CR. In particular, Lederman argues that there was no available
reagent that would permit the specificity of the generated antibodies to be determined.
Additionally, Lederman states that a person skilled in the art would not have been able to
generate antibodies to the CD40CR antigen present on activated human T cell or cell membranes
of activated human T cells as the kinetics of expression of the human CD40CR antigen were
unknown at the relevant time and that CD40CR is not constitutively expressed on activated
human T cells. (Paper No. 116, p. 18).
In contrast, Noelle argues that one skilled in the art would have had a reasonable
expectation of success in producing a monoclonal antibody to the human CD40CR antigen.
First, Noelle alleges that it would have been obvious to one of ordinary skill in the art to produce
a set (  S1  ) of hybridomas that secrete monoclonal antibodies to activated human T-cell surface
antigens. Once the population S1 had been generated, Noelle alleges that, using known and
available techniques, one skilled in the art could then screen the population to identify those
hybridomas that express antibodies specific to CD40CR. (Paper No. 118, p. 14).
Noelle  s opposition cites three particular screening techniques, +/- screening, functional
screening and competitive binding assay, that could be used to identify the desired hybridomas
and their antibodies. (Paper No. 118, pages 14, 18 and 19). The +/- screening technique involves
the testing population S1 of hybridomas to identify a subset (  S1a  ) of hybridomas that express

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antibodies that bind to activated helper T-cells and not to resting helper T-cells. (Paper No. 118,
p. 20 and, Paper No. 133, Noelle Hearing Visual Aids, Tab 4). The functional screening
technique involves testing a specific antibody to determine whether that antibody blocks T-cell
activation of B-cells. (Paper No. 118, p. 14, Paper No. 133, Noelle Hearing Visual Aids, Tabs 5
and 6). The third screening technique, competitive binding assay, is based upon an alleged
expectation that anti-human CD40CR antibodies would compete with soluble CD40Ig for
binding to activated human Th cells, and immunoprecipitate the same protein expressed on
activated human Th cells. (Paper No. 118, pages 15, 19).
At the outset, we note that Noelle has cited and relied upon the Federal Circuit  s decision
in In re Wands as evidence that screening was a known and available technique and that such
screening would not rise to the level of invention. The situation in Wands, however, is
distinguishable from the facts of the present case. Specifically, in Wands the starting materials,
e.g., the HbsAg antigen, were available to the public whereas in the present case the CD40CR
antigen was not available. 858 F.2d at 736, 8 USPQ2d at 1404.
At the relevant time, we find that the known existence of the mouse CD40CR antigen and
the general conservation in function of immune cell molecules across species would have
suggested the existence of the corresponding human CD40CR antigen. As such, one skilled in
the art would have been motivated to identify and obtain anti-CD40CR antibodies via various
conventional techniques, e.g., immunization and screening techniques. Yet, while the idea of
using immunization and screening techniques to obtain anti-human CD40CR antibodies may
have been obvious to try, the realization of that idea would not have been obvious. There were

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many potential pitfalls. Hindsight is not a justifiable basis on which to find that ultimate
achievement of a sought after and difficult scientific goal was obvious. See, Amgen, Inc. v.
Chugai Pharm. Co., 927 F.2d 1200, 1209, 18 USPQ2d 1016, 1023 (Fed. Cir. 1991).
As argued by Lederman, one skilled in the art did not have a reasonable expectation that
any particular activated human T cells expressed CD40CR. (Paper No. 116, p. 6, LX 1093, ¶
53). Moreover, Lederman argues that one skilled in the art had no reasonable expectation of
identifying which activated cells produced the required antigen or of isolating the antigen itself.
(Paper No. 116, pages 6-7). Yet, Noelle  s alleged immunization technique requires activated
human T cells as a source of human CD40CR.
Noelle argues that one skilled in the art, using Noelle  s CD40Ig, could have selected the
appropriate T cells. (Paper No. 118, pages 15, 18 and 20). For example, Noelle states:
Lederman also alleges that producing a monoclonal antibody against activated
human T cells or T cell lines or membranes would be  complicated  by the fact
that CD40CR is not constitutively expressed on activated human T cells. Noelle  s
response is that the ordinary (constitutive) expression not only was not necessary,
the availability of activated cells expressing the antigen and resting cells that did
not [express the antigen] provide a useful +/- screening tool. (NX 2087). The
ordinarily skilled artisan would have known how to select T cells that express
CD40CR on their cell surface using methods disclosed in the Noelle
application, e.g., based on their reactivity with human CD40Ig using flow
cytrometry and a labeled hCd40Ig fusion protein. This procedure is disclosed at
page 15, line 14 to page 16, line 2 of the Noelle application, and would have been
readily apparent to those skilled in the art. (NX 2012, ¶ 25).
(Paper No. 118, pages 19-20, emphasis added).
As discussed above, Noelle cannot rely upon the teachings of its application as  prior art 
evidence to demonstrate the obviousness of Lederman  s corresponding claims. Moreover, as
discussed below, one skilled in the art would not have possessed a reasonable expectation of

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success of forming a CD40Ig fusion protein, which could then be used to obtain the claimed
CD40CR antibodies. Thus, on this record, we conclude that Lederman has provided sufficient
evidence to support a conclusion that, at the relevant time, one skilled in the art would not have
had a reasonable expectation of success of identifying the activated T cells that produced the
required CD40CR antigen or of isolating the antigen itself. Yet, we also conclude that Lederman
has failed to provide sufficient evidence to convince us that this specific diminished expectation
of success is, by and of itself, dispositive of the issue of whether one skilled in the art had a
reasonable expectation of success of obtaining the parties claimed subject matter, i.e., the desired
antibodies or fragments thereof, cell lines and pharmaceutical compositions.
Even assuming that one skilled in the art had a reasonable expectation of success of
identifying activated T-cell lines that expressed CD40CR, we conclude that the screening
techniques cited by Noelle lacked a reasonable expectation of success. Noelle  s +/- screening
technique would lead to the identification of multiple antibodies and not just the claimed anti-
human CD40CR antibody. The +/- screening technique merely creates a subset of antibodies
S1a  that bind to activated helper T-cells and not resting T-cells. Similarly, as there are many
antibodies that inhibit B cell activation, Noelle  s functional screening technique would lead to
the identification of a subset (  S1b  ) of antibodies. Moreover, as discussed in detail below, one
skilled in the art did not have a reasonable expectation of success of making a CD40Ig.
Noelle has failed to convince us that only the desired anti-CD40CR antibody is in both
the S1a and S1b sets or that one skilled in the art could specifically identify and obtain the
desired antibody out of the various screened subsets. As such, we are not convinced that one

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7 Additionally, we note Noelle has argued that the prior art to both Lederman and Noelle
suggested the existence of the CD40CR antigen. (Paper No. 134, p. 38, lines 4-18). Noelle has
also argued that one skilled in the art would have been motivated to obtain the antibodies to the
CD40CR antigen. (Paper No. 134, p. 39, lines 6-14). Furthermore, Noelle has argued that it
would have been obvious to obtain the antibodies via known and available immunization and
screening techniques and that  such screening would not rise to the level of invention.  (Paper
No. 118, p. 14). As evident from the oral argument of September 26, 2001, if we accepted
Noelle  s contention that the prior art provided both: (1) the motivation to obtain the claimed anti-
CD40CR antibodies; and (2) conventional methods for which one skilled in the art had a
reasonable expectation of success of obtaining the claimed anti-CD40CR antibodies, we could be
led to a conclusion that the parties  claims were obvious over the prior art. As we find that, as of
the relevant date, one skilled in the art did not possess a reasonable expectation of success, we
need not explore this issue.
skilled in the art, at the relevant date, would have a reasonable expectation of success that the
anti-CD40CR antibodies could be obtained by the functional and +/- screening techniques,
whether used alone or in combination.
We hold that the combination of Noelle  s anti-mouse CD40CR antibodies, the motivation
to isolate the anti-human CD40CR antibodies and the conventional screening techniques of the
prior art do not render Lederman  s claimed anti-human CD40CR antibodies obvious, but at most
simply suggested a path of inquiry for an inventor to try.7
iii. Prior Art Construction of CD40-Ig Fusion Protein Lacked
Reasonable Expectation of Success
Lederman argues that the use of a human CD40Ig fusion protein would not have enabled
the production of human CD40CR as the synthesis of such a fusion protein, at the relevant date,
would have been  extremely difficult.  As evidence, Lederman cites our Memorandum (Paper
No. 108), fact ¶ 33, which quotes from an affidavit made by Dr. Aruffo (LX 1009) during the
prosecution of Noelle  s parent U.S. Application No. 07/835,799. In the affidavit, Dr. Aruffo

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unequivocally stated that there was  not a reasonable expectation of success prior to the actual
production of a recombinant immunoglobin fusion molecule.  (LX 1009, p. 3).
Noelle, however, relies upon a CD40Ig fusion protein, such as that disclosed in Noelle  s
application, as a potential technique that could be used to immunoprecipitate CD40CR. (Paper
No. 118, p. 15). Moreover, Noelle argues that the CD40Ig described in the Noelle application
provides a  powerful tool for the identification of human CD40CR-expressing T cells.  (Paper
No. 118, p. 18).
Noelle contends that whether or not the formation of a CD40Ig fusion protein was
unpredictable prior to Noelle  s invention is not relevant to the facts of this case. Indeed, Noelle
argues that whether the synthesis of this fusion protein and the properties thereof was
unpredictable is a moot issue in light of the disclosure contained in Noelle  s application. (Paper
No. 118, pages 20-21).
As stated above, Noelle may not rely upon the teachings of its specification as evidence
of the existence of a CD40Ig fusion protein. Moreover, we credit Dr. Aruffo  s undisputed
testimony with regards to the unpredictability and lack of a reasonable expectation of success of
forming a CD40Ig fusion protein. From this, we conclude that one skilled in the art would not
have possessed a reasonable expectation of success of forming a CD40Ig fusion protein, which
could then be used to obtain the claimed CD40CR antibodies.
iv. Prior Art Expression Cloning Techniques Lacked
Reasonable Expectation of Success
Additionally, while not argued by Noelle in its opposition or at oral argument, we take

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8The 07/969,703 application is assigned to Immunex Corporation. The inventors of this
application are said to be Dr. Richard Armitage, William C. Fanslow and Melanie K. Spriggs.
Noelle did not request cross-examination of the inventors of this application.
this opportunity to reiterate our finding from the Memorandum regarding the third method
mentioned by Dr. Clark, expression cloning, and the conclusions that flow from this finding. As
set forth in the Memorandum, as of February 14, 1992, it would have been difficult for one of
ordinary skill in the art to conduct the expression cloning methodology recited in the Noelle  480
application. (Paper 108, p. 16, fact 36). Moreover, as stated during the prosecution of U.S.
Application 07/969,703:8
[A]pplicants submit that, at the time they began their efforts to clone a CD40-L
[i.e., CD40CR], the skilled artisan could not have approached expression cloning
with a reasonable expectation of success (this is still true today [October 1993]).
(October 1, 1993, Amendment and Response and Exhibits attached thereto, filed in U.S.
Application 07/969,703, LX 1083). At the relevant time, we conclude that one of ordinary skill
in the art would not have had a reasonable expectation of success of obtaining the desired anti-
human CD40CR antibodies using a prior art expression cloning technique. (LX 1093 ¶¶ 32 and
33 and LX 1092, page 17, ¶ 45).
3. Lederman  s 	 Human  Claims Would Not Render Obvious
Noelle  s 	 Mouse  Claims
Lederman argues that Noelle  s 	 mouse  claims would have been unobvious over
Lederman  s 	 human  claims due to a lack of a reasonable expectation of success. Noelle,
however, argues that one skilled in the art would have reasonably expected that a monoclonal
antibody to mouse CD40CR could be generated by use of activated mouse T cells or membranes

Interference No. 104,415
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as an immunogen, and screening for monoclonal antibodies that inhibit B cell activation and
which bind to an antigen having a similar size to human CD40CR.
We concluded above that one skilled in the art lacked a reasonable expectation of success
of obtaining Lederman  s claimed 	 human  subject matter when provided with Noelle  s 	 mouse 
subject matter and using the screening techniques cited by Noelle. Likewise, we conclude that
one skilled in the art would have lacked a reasonable expectation of success of obtaining Noelle  s
claimed  mouse  subject matter when provided with Lederman  s claimed 	 human  subject
matter and using these same screening methods. Additionally, we find that the alleged
similarity  in size does not help Noelle. Specifically, as noted by Lederman, the antigen bound
by Lederman  s anti-human CD40CR antibody is said to have a molecular weight of 30
kilodaltons whereas Noelle  s anti-mouse CD40CR antibody binds an antigen that is said to have
a molecular weight of 39 kilodaltons. (Paper No. 129, p. 8). Moreover, Noelle  s expert, Dr.
Clark, has testified that:
[M]olecular weight determinations made by use of SDS-PAGE electrophoresis
procedures are well known to be subject to significant variability, dependent upon
factors including the extent of glycosylation of protein, the nature of
polyacrylamide SDS gel, buffer conditions, among other factors.
(NX 2012, ¶ 26, emphasis added). Thus, one skilled in the art may have had doubts regarding
the accuracy of the molecular weight determinations for the antigens. Furthermore, even if one
skilled in the art were informed that Lederman  s antigen had a molecular weight of 30
kilodaltons, it is unclear whether the person of ordinary skill in the art would have had a
reasonable expectation of success of obtaining the mouse antigen, which was reported to have a
molecular weight of 39 kilodaltons.

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9Lederman Preliminary Motions 6 and 7 were also deferred, however, Lederman has
withdrawn these motions from our consideration.
4. Dispute over Structural and Functional Obviousness
Lederman argues that a monoclonal antibody specific to human CD40CR antigen is
structurally, chemically and functionally distinct from a monoclonal antibody specific to mouse
CD40CR antigen. (Paper No. 116, p. 12). According to Lederman, because the structures and
functions of the mouse and human antibodies are distinct and unobvious over each other, there is
no interference-in-fact between the parties. Noelle disputes this contention. As we have
determined that there was no reasonable expectation of success of obtaining either party  s
corresponding claimed subject matter starting from the others corresponding claims, this issue is
moot.
V. Decision on Deferred Motions
Our Memorandum (Paper No. 108), deferred several preliminary motions. In particular,
Lederman Preliminary Motions 1 and 2 were deferred and Noelle Preliminary Motions 1-4 were
deferred.9
Noelle Preliminary Motions 1 and 3 request that the interfering subject matter be
redefined. In light of our holding that none of Noelle  s remaining corresponding patentable
claims interferes with any of Lederman  s corresponding claims, these motions are denied.
Noelle Preliminary Motions 2 and 4 are contingent upon Noelle Preliminary Motions 1
and 3 and request priority benefit of an earlier filed Noelle application. As Noelle Preliminary
Motions 1 and 3 are denied, Noelle Preliminary Motions 2 and 4 are also denied.

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Lederman Preliminary Motions 1 and 2 generally request judgment against Noelle  s
human  and  genus  claims on the grounds that they are unpatentable over prior art. Noelle,
however, did not contest our finding that Noelle  s 	 genus  and  human  claims lacked written
descriptive support as of the February 14, 1992 filing date and did not contest the unpatentability
of these claims under 35 U.S.C. §102(b). We note, however, that Lederman Preliminary Motion
1 does allege that certain Noelle  mouse  claims are unpatentable over prior art. In light of our
decision that there is no  interference-in-fact  and as Noelle  s claims are present in a pending
U.S. application, a determination as to the patentability of Noelle  s mouse claims is best resolved
outside the course of this interference. Moreover, it is our understanding that Lederman has
agreed to this procedure. Thus, Lederman Preliminary Motions 1 and 2 are dismissed as moot.
VI. Conclusion
Lederman has demonstrated that, as of the relevant date, one of ordinary skill in the art
would not have had a reasonable expectation of success of obtaining an anti-mouse CD40CR
antibody or an anti-human CD40CR antibody. Accordingly, we hold that Lederman has
established that its claimed  human  embodiment is patentably distinct from Noelle  s claimed
mouse  embodiment and vice-versa. Thus, we grant Lederman Preliminary Motion 8.
VII. Order
It is:
ORDERED that Lederman Preliminary Motion 8 is granted.

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FURTHER ORDERED that no interference-in-fact exists between claims 1-7 and 10-13
of Lederman, U.S. Patent No. 5,474,771 and claims 42, 43, 46-48, 50, 54, and 57 of Noelle, U.S.
Application No. 08/742,480.
FURTHER ORDERED that Noelle is not entitled to a patent containing claims 51, 52,
53, 56, 59 and 60 of Noelle, U.S. Application No. 08/742,480.
FURTHER ORDERED that a copy of this final decision shall be placed and given a
paper number in the file of Lederman, U.S. Patent No. 5,474,771 and Noelle, U.S. Application
No. 08/742,480.
RICHARD TORCZON )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
SALLY GARDNER-LANE ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
MICHAEL P. TIERNEY )
Administrative Patent Judge )

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cc: (via Federal Express)
Counsel for Noelle:
Anthony Figg
ROTHWELL, FIGG, ERNST & MANBECK, PC
555 Thirteenth Street, NW
Washington DC 20004
Tel: (202) 783-6040
Fax: (202) 783-6031
Counsel for Lederman:
James F. Haley, Jr., Esq.
Margaret A. Pierri
Jane T. Gunnison
Stanley D. Liang
FISH & NEAVE
1251 Avenue of the Americas, 50th Floor
New York, New York 10020
Tel: (212) 596-9000
Fax: (212) 596-9090