Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01957/USCOURTS-ca13-15-01957-0/pdf.json

Parties Involved:
UCB, Inc.
Appellee
Yeda Research and Development Co., Ltd.
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

UCB, INC.,

Plaintiff-Appellee

v.

YEDA RESEARCH AND DEVELOPMENT CO., LTD.,

Defendant-Appellant

______________________ 

2015-1957

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 1:14-cv-01038-LMBTCB, Judge Leonie M. Brinkema.

______________________ 

Decided: September 8, 2016

______________________ 

JAMES TRAINOR, White & Case LLP, New York, NY,

argued for plaintiff-appellee. Also represented by 

CHRISTOPHER J. GLANCY, ADAM GAHTAN, ROBERT 

COUNIHAN, DIMITRIOS T. DRIVAS, JOHN PADRO. 

NICHOLAS P. GROOMBRIDGE, Paul, Weiss, Rifkind, 

Wharton & Garrison LLP, New York, NY, argued for 

defendant-appellant. Also represented by REBECCA FETT,

CATHERINE NYARADY, DANIEL KLEIN, WILLIAM S. O'HARE 

III. 

______________________ 

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2 UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT

Before NEWMAN, LOURIE, and CHEN, Circuit Judges.

NEWMAN, Circuit Judge. 

In this declaratory judgment action, UCB, Inc. sued 

Yeda Research and Development Co. in the United States 

District Court for the Eastern District of Virginia, requesting a declaration that UCB’s Cimzia® brand antibody does not infringe Yeda’s U.S. Patent No. 6,090,923 

(“the ’923 Patent”); UCB also sought a declaration that 

the ’923 Patent is invalid. Yeda counterclaimed for infringement. The district court granted summary judgment of non-infringement, holding that, based on the

specification and prosecution history, the monoclonal 

antibodies claimed in the ’923 patent are not infringed by

the chimeric or humanized antibodies of the Cimzia®

product.1 We affirm the district court’s judgment. 

BACKGROUND

The ’923 Patent describes and claims a monoclonal 

antibody that binds a defined human cytotoxin. Claim 1 

is representative: 

1. A monoclonal antibody which specifically binds 

a human cytotoxin having a molecular weight of 

about 17,500 as determined by polyacrylamide gel 

electrophoresis, said cytotoxin being obtainable 

from stimulated human monocytes, said cytotoxin 

being further characterized by exhibiting a cytotoxic effect on cycloheximide-sensitized SV-80 

cells and by being obtainable in a state of enhanced purity by adsorption of the cytotoxin from 

an impure preparation onto controlled pore glass 

 

1 UCB, Inc. v. Yeda Research and Dev. Co., 117 F. 

Supp. 3d 755 (E.D. Va. 2015) (“Dist. Ct. Op.”).

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UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT 3

beads, and subsequent desorption of the cytotoxin 

in a state of enhanced purity.

’923 Patent, col. 6, ll. 54-63. The question is whether the 

monoclonal antibody of claim 1 includes chimeric or 

humanized antibodies, when the patent specification 

describes only murine (mouse) monoclonal antibodies. 

Yeda argues that since chimeric monoclonal antibodies 

were known at the time the ’923 priority application was 

filed in 1984, the claims should be construed to cover such 

chimeric antibodies, as well as humanized antibodies. 

UCB responds that the prosecution history prohibits

coverage of chimeric and humanized antibodies, and that 

claim 1 cannot be construed to cover those types of antibodies. 

The ’923 specification states that the “CT [cytotoxin] 

can be isolated by the use of monoclonal antibodies 

against such CT which can be obtained from mice injected 

with partially purified or crude preparations of CT.” Col. 

1, l. 66–col. 2, l. 1. The specification states that “a monoclonal antibody specific for CT . . . is produced by such 

hybridoma cell lines and is used for isolating CT in substantially homogenous purified form.” Col. 2, ll. 6–9. The 

specification presents examples of isolating, partially 

purifying, and characterizing the cytotoxin, raising and 

purifying the mouse monoclonal antibody, and using this 

mouse antibody to bind the cytotoxin.

The claims as originally filed described the antibody 

as a “monoclonal antibody,” but during a lengthy prosecution Yeda first limited all the claims to murine antibodies, 

and then sought to remove this limitation, stating:

New claims 41 and 42 are being submitted herewith in order to present claims identical to presently appearing claims 38 and 39 without 

requiring that the monoclonal antibodies be murine monoclonal antibodies. Arguments have previously been made in this prosecution history that 

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4 UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT

the recitation of “murine” with respect to the 

monoclonal antibody helps to distinguish the present claims over the references such as Matthews 

and Wallace which disclose obtaining rabbit polyclonal antibodies. However, it is now believed 

that recitation of “murine” is unduly limiting and 

that claims 41 and 42 are allowable for the same 

reasons as argued in applicants’ amendment of 

April 21, 1998 with respect to claims 38 and 39.

Amendment letter of June 30, 1998 at 2.

The examiner rejected the new claims 41 and 42, on 

the ground that the specification did not “provide enablement for the claimed ‘monoclonal antibodies’ from a broad 

range of species.” Office Action of Sept. 10, 1998 at 3. 

Yeda then argued that “the term should encompass 

chimeric monoclonal antibodies,” stating:

The term “monoclonal antibody” is defined . . . as 

“an antibody produced by culturing a single type 

of cell”, which “consists of a single species of immunoglobulin molecules.” We do not believe that 

the term necessitates that the monoclonal antibody be produced by the original hybridoma cell; 

the term should encompass chimeric monoclonal 

antibodies produced by a genetically engineered 

cell line.

Amendment letter of March 10, 1999 at 3 (footnote omitted). The applicants’ letter continued:

Applicants are particularly interested in protecting chimeric forms of their anti-cytotoxin mouse 

monoclonal antibodies. One of the reasons for 

their insistence on not limiting the claims to 

“mouse” monoclonal antibodies is uncertainty as 

to whether that would literally cover a humanized 

or chimeric derivative of a mouse monoclonal antibody. Any suggestions by the Examiner as to 

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UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT 5

how to reconcile Applicants’ concerns with the Examiner’s concerns as to enablement would be 

greatly appreciated.

Id. at 5–6. The amendment also added proposed claims 

45-48, all of which expressly encompassed chimeric antibodies. 

Thus Yeda argued to the Examiner that humanized or 

chimeric derivatives of mouse monoclonal antibodies were 

contemplated, and should be included in the claims. Yeda 

submitted the declaration of Dr. Hartmut Engelmann, 

stating that it was within the level of skill at the application date to produce monoclonal antibodies from species

other than murine. Engelmann Declaration, May 18, 

1999 at 2. The Declaration also cited two references that 

preceded the effective filing date, describing mousehuman chimeric antibodies. Id. at 3–4.

The Examiner withdrew the rejection for lack of enablement “in view of the applicant’s arguments and the 

declaration of Hartmut Engelmann.” Office Action of 

June 7, 1999 at 3. However, the Examiner rejected the 

proposed new claims 45-48, which were specific to “rat, 

hamster and human antibodies and chimeras thereof” and 

to “chimeras of” mouse monoclonal antibodies and “nonmurine” monoclonal antibodies; the Examiner stated that 

these claims added new matter and were not supported in 

the specification. Id. The Examiner did not respond to 

Yeda’s request for assistance in protecting the use of 

chimeric or humanized antibodies in the claimed subject 

matter. 

Yeda then cancelled all the claims that Yeda had proposed to specify chimeric antibodies. The claim that 

became patent claim 1, filed as claim 41, did not mention

chimeric antibodies, and had not been amended during 

prosecution with respect to that aspect. On UCB’s motion 

for summary judgment, the district court held that this 

history prohibits construction of claim 1 to cover humanCase: 15-1957 Document: 49-2 Page: 5 Filed: 09/08/2016
6 UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT

ized and mouse-human chimeric antibodies, and thus the 

court granted summary judgment of non-infringement.

DISCUSSION

The issue on summary judgment was presented as a 

question of claim construction. Claim construction is a 

matter of law, based on underlying facts. Teva Pharm. 

USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015). Summary judgment may be appropriate when there is no 

genuine dispute as to any material fact and the movant is 

entitled to judgment as a matter of law. Fed. R. Civ. P. 

56; Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48

(1986).

The district court construed “monoclonal antibody,” as 

used in the ’923 patent specification and claims, to mean 

“a homogenous population of a single type of antibody 

produced via hybridoma and not including chimeric or 

humanized antibodies.” Dist. Ct. Op. at 774. We agree 

that the prosecution history requires this construction, for 

the scope now sought by Yeda was requested of the Examiner, and refused on the ground of new matter. Yeda

argues that present claim 1 was never rejected on this 

ground; Yeda states that only the specific species claims 

were deemed by the Examiner to contain new matter.

The district court held that all the claims, correctly 

construed, exclude chimeric or humanized antibodies, the 

court stating that “[e]xamination of the prosecution 

history reveals that for the first ten years of prosecution, 

neither Yeda nor the examiner understood the term 

‘monoclonal antibodies’ to include chimeric or humanized 

antibodies. Like the evidence in the specification, the 

prosecution history weighs towards a construction of 

‘monoclonal antibodies’ which does not include chimeric or 

humanized antibodies.” Dist. Ct. Op. at 770. On this 

ground, the court found non-infringement.

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UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT 7

Yeda argues that the district court erred in construing 

the claims to find non-infringement, instead of construing 

the claims objectively. Yeda states that the “claims 

should not be construed with the goal of including or 

excluding the accused product.” Yeda Br. 38. Yeda points 

out that claim 1 does not mention any particular monoclonal antibody or species of chimera, and should not be 

limited to the examples in the specification. Yeda states 

that every embodiment need not be specifically described 

and claimed to be within the scope of a generic term in a 

claim. 

Yeda is correct in that generic terms in claims are 

construed in light of that which is already known. However, the content of the specification and actions and 

arguments during prosecution must also be considered, in 

defining the scope of a generic term in a claim. See Advance Transformer Co. v. Levinson, 837 F.2d 1081, 1083 

(Fed. Cir. 1988) (“Positions taken in order to obtain allowance of an applicant’s claims are pertinent to an understanding and interpretation of the claims that are granted 

by the PTO . . . and may work an estoppel as against a 

subsequent different or broader interpretation.”). 

During prosecution, Yeda submitted new claims specific to “rat, hamster and human antibodies and chimeras 

thereof” as well as claims specifically encompassing

“chimeras of” mouse monoclonal antibodies and “nonmurine” monoclonal antibodies. Yeda argued that its invention is not limited to murine antibodies to human 

cytotoxin, and “should encompass chimeric monoclonal 

antibodies produced by a genetically engineered cell line.” 

Amendment Letter of March 10, 1999 at 2, 3. The Examiner rejected the proposed claims on the ground of new 

matter not supported in the specification. Yeda then 

withdrew the proposed specific claims, and the application was passed to issuance. The district court held that 

Yeda cannot now obtain a claim construction that recovers claim scope that was yielded in order to obtain issuCase: 15-1957 Document: 49-2 Page: 7 Filed: 09/08/2016
8 UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT

ance of the patent, and construed the claims as excluding 

chimeric and humanized antibodies. 

Yeda argues that this construction is incorrect at least 

as to claim 1, which recites “monoclonal antibody” but

does not specify any specific form or source of antibody. 

Yeda states that chimeric or humanized monoclonal 

antibodies were known at the time its priority application 

was filed, December 20, 1984, and thus should be included in the monoclonal antibodies of claim 1. Yeda presented a publication of Morrison dated November 1, 1984, that 

describes chimeric antibodies, and cited a December 8, 

1984, Nobel Prize speech by César Milstein referring to 

chimeric antibodies. The district court responded to these 

arguments, stating: “At best, these references establish 

that scientists knew of chimeric antibodies in November 

1984. Establishing that chimeric antibodies existed in 

1984, however, is different from establishing that a person of ordinary skill in the art would have understood 

chimeric antibodies to be monoclonal antibodies in 1984.” 

Dist. Ct. Op. at 772. 

The district court concluded that “the extrinsic evidence relied upon by Yeda’s experts does not support the 

conclusion that the understanding of ‘monoclonal antibodies’ in 1984 included either chimeric or humanized antibodies.” Id. The district court found that “for the first ten 

years of prosecution, neither Yeda nor the examiner 

understood the term ‘monoclonal antibodies’ to include 

chimeric or humanized antibodies.” Id. at 770. The 

district court held that Yeda’s unsuccessful attempt to 

claim chimeras in the pending application, with acquiescence in the examiner’s rejection on the ground of new 

matter not supported by the specification, prohibited now 

obtaining a claim construction that chimeric antibodies, 

or equivalents thereof, are described in the specification

and included in the claims.

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UCB, INC. v. YEDA RESEARCH AND DEVELOPMENT 9

Yeda argues that absent a narrowing amendment to 

the proposed claim that is now claim 1, there can be no 

prosecution estoppel to the scope of claim 1, merely because some proposed different claims were rejected by the 

examiner and then dropped by the applicant. That is not 

a correct general principle. Although each claim in a 

patent warrants independent consideration in light of its 

particular facts and history, the general rule is that a 

patent applicant cannot later obtain scope that was 

requested during prosecution, rejected by the Examiner, 

and then withdrawn by the applicant.

Such estoppel was reasonably applied to claim 1 by 

the district court, although claim 1 had not been amended. In Builders Concrete, Inc. v. Bremerton Concrete 

Products Co., 757 F.2d 255, 259 (Fed. Cir. 1985), the court 

rejected the argument that “file wrapper estoppel cannot 

arise without an amendment,” and explained that the 

“position must be evaluated in the context of this specific 

case.” In Wang Laboratories, Inc. v. Mitsubishi Electronics America, Inc., 103 F.3d 1571, 1578 (Fed. Cir. 1997), 

the court again explained: “We examine the statements 

and actions of the patentee before the PTO during prosecution . . . and ask what a competitor reasonably may 

conclude the patentee surrendered to gain issuance of the 

patent.” (internal citations omitted).

We conclude that the district court correctly applied 

the law, and we affirm the holding that Yeda is estopped 

from including chimeric and humanized antibodies within

the scope of the monoclonal antibodies claimed in the ’923 

Patent. 

AFFIRMED

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