Milton D. Goldenberg and Immunomedics, Inc. v. Cytogen, Inc. And C.R. Bard, Inc.

373 F.3d 1158, 71 U.S.P.Q. 2d (BNA) 1255, 2004 U.S. App. LEXIS 12442, 2004 WL 1393816
CourtCourt of Appeals for the Federal Circuit
DecidedJune 23, 2004
Docket03-1409
StatusPublished
Cited by58 cases

This text of 373 F.3d 1158 (Milton D. Goldenberg and Immunomedics, Inc. v. Cytogen, Inc. And C.R. Bard, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Milton D. Goldenberg and Immunomedics, Inc. v. Cytogen, Inc. And C.R. Bard, Inc., 373 F.3d 1158, 71 U.S.P.Q. 2d (BNA) 1255, 2004 U.S. App. LEXIS 12442, 2004 WL 1393816 (Fed. Cir. 2004).

Opinions

Opinion for the court filed by Circuit Judge GAJARSA. Opinion concurring-in-part and dissenting-in-part filed by Circuit Judge PROST.

GAJARSA, Circuit Judge.

Milton D. Goldenberg (“Goldenberg”) and Immunomedics, Inc. (collectively, “Im-munomedics”), appeal from the grant of a motion for summary judgment of nonin-fringement of United States Patent No. 4,460,559 (the “'559 patent”) in favor of Cytogen, Inc., and C.R. Bard, Inc. (collectively, “Cytogen”), by the United States District Court for the District of New Jersey. Goldenberg v. Cytogen, Inc., 2003 WL 22454399, No. 00-763(AET) (D.N.J. Apr. 30, 2003) (“Summary Judgment Opinion ”). While we agree with the district court’s claim construction, and that summary judgment of no literal infringement was appropriate, we disagree with the grant of summary judgment of nonin-fringement under the doctrine of equivalents. Accordingly, we affirm-in-part, reverse-in-part, and remand.

I. BACKGROUND

A. The Patents and the Prosecution History

The '559 patent is entitled “Tumor Localization and Therapy with Labeled Antibodies Specific to Intracellular Tumor-Associated Markers.” The invention is a method for detecting and localizing tumors by targeting “intracellular marker substances” that are produced by or associated with tumor cells. '559 patent, col. 2,11. 19-27. The claimed method includes injecting a subject with a radioactively highlighted antibody specific to the “marking substance,” which, when scanned, reveals the location of concentrations of the “marking substance” within the body. Claim 1 of the '559 patent claims:

A method for detecting and localizing a tumor which either produces or is associated with an intracellular marker substance, which comprises injecting a subject parenterally with an antibody specific to said marker substance and radiolabeled with a pharmacologically inert radioisotope capable of detection using a photoscanning device, and subsequently scanning with said device to detect and locate the site or sites of uptake of said labeled antibody by said tumor; with the proviso that when said antibody is an antibody specific to human chlorionic [sic] gonadotropin or its beta-subunit, said radioisotope is other than Tc-99m.

Id. at col. 15, ll. 24-35 (emphases added).

The written description of the '559 patent does not define the term “intracellular marker substance.” It does, however, discuss the previous understanding in the art that tumor localization required “antibodies which were specific to antigens located on the surface of the tumor cell....” Id. at col. 1, ll. 25-32. The written description further explains:

The antibodies used in the present invention are specific to a variety of intracellular tumor-associated antigens as marker substances. These markers may be substances produced by the tumor or may be substances which accu-[1161]*1161muíate within tumor cells, whether in the cytoplasm, the nucleus or in various organelles or subeellular structures.

Id. at col. 2, ll. 36-40 (emphasis added).

The '559 patent issued on July 17, 1984 from an application, Ser. No. 374,662 (the “'662 application”), filed by Goldenberg on May 4, 1982. The '662 application is a continuation of another application, Ser. No. 126,261 (the “'261 application”). Goldenberg also filed a second application, Ser. No. 126,262 (the “'262 application”), simultaneously with the '261 application. The '262 application led to a continuation-in-part application, Ser. No. 414,729 (the “ '729 application”), which resulted in United States Patent No. 4,444,744 (the “'744 patent”). In the first office action after the filing of the '261 and '262 applications, the Examiner rejected the claims of the '261 application in their entirety. Claims 15-22 and 28-29 of the '261 application were specifically rejected on double patenting grounds over the '262 application.

Attempting to overcome the examiner’s rejection, Goldenberg explained:

[t]he method and compositions claimed in the [’261 application] relate to intracellular tumor associated antigens. Before the work of the present inventor, the art did not know that antibodies to such intracellular antigens, e.g., human chorionic gonadotrophin (HCG) and alpha-fetoprotein (AFP) could be successfully used for tumor localization and therapy. Accordingly, the claims of the present application do not overlap claims in [the '262 application], since the latter application claims methods and compositions for tumor localization and therapy' to CEA alone.

Response to Office Action Dated March 24, 1981, at 2-3. In the same response, Im-munomedics explained “[a]s noted above, the[ ] claims [of the '261 application] do not overlap with claims to methods and compositions for tumor localization and therapy using radiolabeled antibodies to CEA, a cell surface antigen.” Id. at 3-4 (emphasis in original).

Throughout the response, Goldenberg distinguished the methods of the '261 application, which focused on intracellular antigens, from the subject matter of the '262 application, which involved cell surface antigens. See, e.g., id. at 4 (“The present specification ... explains that the prior art considered that tumor localization in man using injected radiolabeled tumor-associated antigens required antibodies which were specific to antigens located on the surface of the tumor cell.” (emphasis added)); id. at 6 (“Reid relates to a surface glycoprotein useful in identifying the presence of tumors ....”); id. at 7 (“Furthermore, it was not known prior to applicant’s work in this field that antibodies to non-surface antigens would preferentially localize in human tumors.” (emphasis added)); id. at 10 (“The reference discloses that CEA is a surface antigen whereas alpha-fetoprotein (AFP) is a cytoplasmic or intracellular antigen.”). Despite the frequency with which the distinction appears in the prosecution history, the '261 application did not define “intracellular marker substance.”

The Examiner allowed claims 25-30 of the '261 application, which issued as United States Patent No. 4,361,544 on November 30, 1982. Goldenberg also continued the prosecution of the remaining claims in the '261 application with the '662 application, which resulted in the '559 patent. On September 3, 1982, Immunomedics filed the '729 application, a continuation-in-part of the '262 application.' The '729 application defined the term “cell surface antigen” and incorporated by reference a 1972 article by S.J. Singer and Garth Nicholson [1162]*1162(the “Singer article”),1 which contained a further discussion of various antigens associated with a cell membrane. The '729 application matured into the '744 patent on April 24,1984.

B. The Accused Product

Cytogen manufactures and sells Prosta-Scint. ProstaScint contains the antibody 7E11-C5.3, which is specific to prostate specific membrane antigen (PSMA). PSMA is a transmembrane antigen, extending through the cell membrane and having both intracellular and extracellular domains. 7E11-C5.8 is covered by United States Patent No. 5,162,504, which is assigned to Cytogen.

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373 F.3d 1158, 71 U.S.P.Q. 2d (BNA) 1255, 2004 U.S. App. LEXIS 12442, 2004 WL 1393816, Counsel Stack Legal Research, https://law.counselstack.com/opinion/milton-d-goldenberg-and-immunomedics-inc-v-cytogen-inc-and-cr-bard-cafc-2004.