CellPro, Inc. appeals from the decision of the United States District Court for the District of Delaware in favor of Johns Hopkins University, Baxter Healthcare Corporation, and Becton Dickinson and Company (collectively, Hopkins) in their patent infringement suit against CellPro. The court (1) granted Hopkins’ motion for judgment as a matter of law that CellPro infringed claims 1-5 of U.S. Patent B1 4,714,680,
see Johns Hopkins Univ. v. CellPro,
BACKGROUND
A. The Technology
The ’680 and ’204 patents (the “Civin patents”) issued from continuations of the same parent application
1
and pertain generally to relatively pure suspensions of immature blood cells and monoclonal antibodies used to produce such suspensions. These immature cells, known as “stem” cells, develop into many different forms of mature blood cells, including lymphoid cells (T-cells and B-cells) and myeloid cells (red cells, platelets and granulocytes).
See generally Hopkins I,
Because stem cells are killed by radiation therapy, these cells must be replaced in leukemia patients who have undergone this treatment. While bone marrow transplants can provide a patient with new stem cells, this procedure carries risks. Notably, the presence of mature cells in transplanted bone marrow can give rise to Graft Versus Host Disease (GVHD), a potentially fatal condition.
2
Accordingly, one of the stated objec
*1347
tives of the invention of the Civin patents “is to provide a method for preparing a cell population useful for stem cell transplantation that is enriched in immature marrow cells and substantially free of mature myeloid and lymphoid cells.” ’680 patent, col. 2, Il. 1-5;
see also Hopkins I,
In the early 1980s, scientists began making monoclonal antibodies 3 that would recognize and bind to the antigens contained on the surface of blood cells. Once an antibody binds to an antigen on a cell surface, that cell is flagged and can be separated from other cells using known techniques such as the “FACS” method. 4 Monoclonal antibodies, which are uniform in their binding properties, are produced by cloned cells known as hybridomas. 5 Hybridomas grow and reproduce rapidly and can be frozen for later use to produce additional monoclonal antibodies.
Dr. Curt Civin, the inventor named in the ’680 and ’204 patents, discovered an antigen, which he named My-10, that appears on the surface of immature stem cells but not on the surface of mature cells. 6 The patents’ specifications disclose a monoclonal antibody, which Civin named anti-My-10, which recognizes the My-10 antigen and is useful in separating stem cells from mature cells. The patents further disclose how a hybridoma which manufactures the anti-My-10 antibody can be produced and note that a sample of the hybridoma has been deposited with the American Type Culture Collection (ATCC), ATCC Accession No. HB-8483, in Rockville, Maryland.
The ’680 and ’204 patents claim, respectively, a purified cell suspension of stem cells and monoclonal antibodies useful in producing such a suspension. The parties do not draw distinctions between the various claims in the patents, and instead premise their arguments as to each patent solely on independent claim 1 of each patent. These claims are set forth below with the disputed limitations from each claim emphasized:
’680 Claim 1: “A suspension of human cells comprising pluripotent lympho-hema-poietie stem cells substantially free of mature lymphoid and myeloid cells.”
’204 Claim 1: “A monoclonal antibody which specifically binds to an antigen on nonmalignant, immature human marrow cells, wherein said antigen is stage specific and not lineage depen- ■ dent, and soid antigen is also specifically bound by the antibody produced by the hybridoma deposited under ATCC Accession No. HB-8Í8S- ■ • - ” 7
B. CellPro’s Activities and Accused Products
1. CellPro’s Technology
Four years after the filing date of the parent application of the Civin patents, Dr. *1348 Ronald Berenson, a scientist at the Fred Hutchinson Research Center, developed a method of physically separating stem cells from mature cells that was similar to that disclosed in the Civin patents. The monoclonal antibody developed by Berenson for this purpose was designated the 12.8 antibody. 8
Berenson and others at Hutchinson formed CellPro in 1989 and obtained licenses from Hutchinson for the use of Berenson’s cell separation technology. In July 1990, CellPro produced, by cloning, a master cell bank constituting 100 vials of 12.8 hybridoma. Some of these vials were subsequently thawed and cloned to create a working cell bank to produce the 12.8 antibody. CellPro began to sell two machines, the Ceprate LC and the Ceprate SC, which its customers used in conjunction with the 12.8 antibody to perform Berenson’s cell separation method.
2. CellPro’s Knowledge of the Civin Patents and its Procurement of Legal Opinions
At the time CellPro was formed, representatives of CellPro knew of the ’680 cell suspension patent, which issued on December 12, 1987. They had also monitored the Official Gazette of the Patent and Trademark Office to determine if Civin had been issued any antibody-related patent; the ’204 antibody patent, which issued on October 23, 1990, was so discovered.
See Hopkins II,
Ostensibly concerned that CellPro’s activities might fall within the scope of the ’680 patent, Thomas Kiley, a member of CellPro’s Board of Directors and the company’s legal advisor, engaged the law firm of Lyon & Lyon LLP and its partner Coe Bloomberg in early April 1989 to provide an opinion on the validity of the claims of the ’680 patent. Bloomberg apparently reported to the Cell-Pro board in May and September 1989 that he had reviewed the prosecution history of the patent and had concluded that the patent was invalid. Bloomberg’s oral opinion was first reduced to writing on February 27, 1990. That later written opinion concluded that the claims of the ’680 patent were invalid over several pieces of prior art and were unenforceable for inequitable conduct. Cell-Pro used Bloomberg’s opinion letter to assist it in raising an additional $7.5 million from investors. See id.
In the spring of 1991, CellPro’s board asked Bloomberg for an opinion concerning the ’204 patent. Bloomberg apparently prepared a draft opinion and submitted it to Kiley, who reviewed it and provided Bloom-berg with comments. This opinion, like the ’680 opinion, concluded that the claims were invalid and unenforceable. Bloomberg also opined that CellPro did not infringe claims 2, 3, 5, and 6, but was silent as to infringement of claims 1 and 4, the claims asserted in this action. The ’204 opinion letter was also used by CellPro as a mechanism for inducing investment in the company. In the prospectus accompanying CellPro’s public offering, the company reported that “[bjased on the advice of Lyon & Lyon, special patent counsel to the company, Cell-Pro believes that [the Civin] patents are invalid and unenforceable.” Id. at 189 (internal quotations omitted).
By December of 1991, CellPro had set aside $3 million as a reserve for potential litigation involving the Civin patents. Cell-Pro also made provision in its financial forecasts for the possibility that it would litigate and lose, and be forced to pay a “stiff royalty” of 15% as damages. Id.
C. The District Court Litigation
1. Infringement
Hopkins, assignee of the Civin patents, and its licensees, Baxter Healthcare and Becton *1349 Dickinson, sued CellPro on March 8, 1994, alleging infringement of certain claims of the ’204 patent. CellPro, inter alia, counterclaimed for a declaratory judgment of invalidity and noninfringement of certain claims of the ’680 patent, prompting Hopkins to sue CellPro for infringement of that patent as well. 9
The case was tried to a jury beginning on July 24, 1995. The district court reserved construing the claims until after the presentation of evidence. At that time, the court considered but did not provide the jury with instruction concerning the meaning of the disputed limitations, concluding that the language contained therein could be understood according to its ordinary meaning.
See Johns Hopkins Univ. v. CellPro,
Hopkins brought a renewed motion for judgment as a matter of law and in the alternative moved for a new trial, asserting, inter alia, that the court had erred in its construction of the disputed claim limitations. The court agreed that its failure to construe the disputed limitations appeared to be in error, see id. at 313, 317, and revisited these and other questions in considering the motion.
a. The ’680 Patent
As to the “substantially free” limitation of the ’680 claims, the district court, in considering the motion, was “reluctant to impose mathematical certainty on an ambiguous term when [the] patent applicant has strenuously avoided doing so.”
Id.
at 318. However, despite this reluctance, the court adopted a construction that required “a cell suspension of at least 90% purity”; in other words, “the cell suspension must contain no more than 10% mature lymphoid and myeloid cells” in order to be within the scope of the claims.
Id.
The court noted that its construction was consistent with the patent’s specification and with expert testimony offered at trial. The court observed that while the specification did not explicitly define the meaning of the words “substantially free,” the specification did acknowledge that the techniques used to assess the purity of My-10-positive populations “have not detected any appreciable number (i.e., not significantly above background) of normal mature ... cells.” ’680 patent, col. 3, 11. 64-67. The court, however, found persuasive Civin’s deposition testimony that one of ordinary skill would interpret the words “substantially free” in accordance with the limitations of the disclosed FACS cell separation technique which was capable of producing cell suspensions of 85-90% purity. Finally, the court noted that its construction was consistent with the patent’s disclosure of the production of a stem cell suspension of 90% purity in Table 9.
10
See Hopkins I,
Following its first real construction of the words “substantially free,” the court granted Hopkins’ motion for judgment as a matter of law on the issue of literal infringement. The court noted that Hopkins could prove' infringement without testing the accused cell suspensions,
see id.
at 319 (citing
Allen Archery, Inc. v. Browning Mfg. Co.,
The court also granted Hopkins’ motion for a new trial on the issue of the obviousness of the asserted claims of the ’680 patent,
see id.
at 321; 35 U.S.C. § 103 (1994), because,
inter alia,
the three references upon which Cell-Pro relied to establish obviousness
(viz.,
Civ-in, Koeffler, and Amato) were not listed on CellPro’s pre-trial order and therefore were not properly before the jury.
See Hopkins I,
b. The ’WJp Patent
The district court agreed with Hopkins that the “wherein” clause of the ’204 claims referred to an antigen that was now more simply understood by those of ordinary skill in the field as the “CD34 antigen,”
13
and adopted a claim construction that reflected this understanding.
Hopkins I,
Those skilled in the art of making monoclonal antibodies, however, clearly under *1351 stand that My-10 and CD34 are the same. The attorney prosecuting the application for the ’204 patent argued that My-10 was becoming known in the art as CD34 as a result of the International Leukocyte Workshops. The examiner recognized this when she observed that claim 1 “limits the claimed monoclonal antibodies to species that react with a particular antigen (now identified as CD-34).”
Id. at 314. Accordingly, the court concluded that the “wherein” clause was an “attempt to describe a specific physical entity, which those skilled in the art now call the CD34 antigen,” and furthermore that any antibody which binds to this antigen would infringe the asserted claims. Id.
In light of this construction, the court granted Hopkins’ motion for a new trial on the issue of literal infringement. The court concluded that “[t]he evidence offered at trial, including [that] through CellPro’s own experts, establishes that the 12.8 antibody binds to the CD34 antigen.” Id. at 316. Rather than grant Hopkins’ renewed motion for judgment as a matter of law, the court at first allowed CellPro to attempt to establish a foundation to support its theories of nonin-fringement, which mostly hinged upon proof that the 12.8 antibodies bind to mature baso-phils. See id. at 316, 317. However, the court soon thereafter granted Hopkins’ motion for summary judgment on the issue of literal infringement, essentially concluding that the evidence that the 12.8 antibody binds to different species was irrelevant given that it binds to the CD34 antigen. See Johns Hopkins Univ. v. CellPro, Civ. No. 94-105-RRM (D.Del. Nov. 27, 1996).
The court also granted Hopkins’ motion for a new trial concerning lack of enablement of the claims of the ’204 patent.
See Hopkins I,
the weight of the evidence suggests that the ’204 patent is enabled. Despite the fact that CellPro’s experts claim that the ’204 patent i[s] not enabling, none of them can identify anything that is missing from the specification. By contrast, the specification states that Civin’s' hybridoma is on deposit for others to utilize. In addition, the specification describes the entire fusion process, including' the immuno-gen, which is also on deposit, the specific type of mice immunized, and the use of the methodology utilized by Kohler and Mil-stein. [ 14 ]
Hopkins I,
CellPro further argued in the district court that the asserted claims of the ’204 patent were invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112, ¶ 1 (1994). The court, from the bench, granted CellPro permission to assert this defense, but then granted summary judgment to Hopkins’ on the merits. See Johns Hopkins Univ. v. CellPro, Civ. No. 94-105-RRM (D.Del. Oct. 31, 1996) (transcript at 12-13).
2. Damages and Willful Infringement
With CellPro’s liability for infringement decided by the grant of Hopkins’ various motions, the issues of damages and willful infringement were tried to a jury beginning March 4, 1997.
See Hopkins II,
so obviously deficient, one might expect a juror to conclude that the only value they had to CellPro in the world outside the courtroom would have been to file them in ' a drawer until they could be used in a cynical effort to try and confuse or mislead what CellPro, its Board, and counsel must have expected would be an unsophisticated jury.
Hopkins II,
• 3. The Repatriation Order
As part of the district court’s permanent injunction order, Johns Hopkins Univ. v. CellPro, Civ. No. 94-105-RRM (D.Del. Jul. 24, 1997), the court ordered CellPro to repatriate to the United States “all clones or subclones of the 12.8 hybridoma cell line previously exported by it, as well as any further clones or subclones produced therefrom,” and any antibodies produced there *1353 from. Id. at 3-4. This order encompassed six vials of 12.8 hybridoma from CellPro’s United States cell bank which CellPro sent to its Canadian business partner, Biomira, Inc., and cloned vials and antibodies produced therefrom in Canada. These six vials, like the other vials in the cell bank, were created prior to the issuance of the ’204 patent, the only patent that is relevant to the 12.8 hybri-doma, but were sent to Canada during the term of that patent. The six vials were never thawed or used in any manner prior to their export. One of the six vials was cloned in Canada to produce a working Canadian cell bank of 32 vials of 12.8 hybridoma. Under CellPro’s contract with Biomira, Biomira thawed and used the hybridoma from the Canadian cell bank to make 12.8 antibodies for the performance of the Berenson cell separation technique in Canada. Title to the hybridoma, however, remained with CellPro.
In its memorandum opinion supporting its repatriation order, the court did not find compelling CellPro’s argument that none of its activities concerning the six vials exported to Canada were infringing uses under 35 U.S.C. § 271 and that they were thus free of the court’s equitable power to order repatriation:
CellPro argues that because it shipped cells that were part of the original batch of noninfringing cells — rather than those that were cloned [after the issuance of the ’204 patent in the United States] — it did not run afoul of § 271(a). The court finds this distinction to be immaterial. CellPro created the 12.8 hybridoma with the intention of developing a bank of identical cells to produce a monoclonal antibody — the 12.8 antibody. Thus, by using some cells in the [United States cell] bank for the purpose of cloning or testing, it is committing an infringing “use” with respect to the bank as a whole.
Accordingly, because CellPro created and maintained its hybridoma in Canada as a result of infringing activities in the United States, the court finds that it will be acting within its equitable powers under 35 U.S.C. § 283 by ordering CellPro to repatriate the hybridomas stored at Biomira. Doing so would tend to reestablish the status quo as it existed before CellPro willfully infringed the asserted claims of the ’204 patent.
Id. at 27 (memorandum opinion).
CellPro appealed numerous points of error to this court. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1) (1994).
DISCUSSION
A. Standard of Review
Judgment as a matter of law (JMOL) is appropriate when “a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue.” Fed.R.Civ.P. 50(a)(1). We review a district court’s decision on a motion for JMOL
de novo,
reapplying the JMOL standard.
See Markman v. Westview Instruments, Inc.,
“[T]he determination whether a claim has been infringed requires a two-step analysis: First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process.”
Carroll Touch, Inc. v. Electro Mechanical Sys., Inc.,
Because courts have broad discretion in determining the scope of injunctive relief under 35 U.S.C. § 283 (1994), we review the scope of a district court’s permanent injunction for an abuse of discretion.
See Ortho Pharm. Corp. v. Smith,
Whether infringement was willful is a question of fact, and we will not reverse a jury determination on this issue unless it was unsupported by substantial evidence.
See Hoechst Celanese Corp. v. BP Chems. Ltd.,
B. Validity and Infringement of the ’680 Patent
1. Claim Construction and Infringement
CellPro asserts that the district court’s construction of the “substantially free” limitation to require no more than 10% mature cells was in error. Instead CellPro believes that this limitation should be construed to mean an immeasurable amount of mature cells. Accordingly, CellPro contends that JMOL of infringement was erroneously granted, because cell suspensions produced by its technique and equipment contained measurable amounts of mature cells numbering in the “millions.”
To support its claim construction, CellPro points to the prosecution history of the ’680 patent, which progressed in relevant part as follows: The examiner rejected the claims as anticipated by two prior art publications by Bodger et al. The applicant responded by noting that Bodger’s antibodies could not be used to produce a cell suspension that was “substantially free” of mature cells as required by the claim language. The examiner was not persuaded and noted that “[t]he metes and bounds of ‘substantially free’ have not been established” by the applicant, to which the applicant responded:
“Substantially free” is defined by its plain meaning and further by the stated characteristics of the anti-My-10 antibody_ At page 5, lines 27-31, of the specification [see ’680 patent, col. 6, 11. 62-67] it is explicitly stated, “Various assay techniques have been employed to test for the presence of the My-10 antigen, and those techniques have not detected any appreciable number (i.e., not significantly above background) of normal, mature human myeloid and lymphoid cells in My-10-positive populations.” For example, when My-10 + cells are incubated with a series of monoclonal antibodies which react with T-lymphocytes [i.e., a type of mature cell], no cells are found to be reactive. Thus, by the means presently available to the art, no T-lymphocytes are found in My-10 + cell populations.
*1355 (emphasis in original). 17 The applicant also noted that “Bodger’s cell population has some T-eells present, but [that] the present invention has none,” and therefore that Bodger’s cell suspension would be ineffective in preventing GVHD.
Hopkins responds that the district court’s claim construction was correct and was consistent with the intrinsic evidence. Hopkins notes that the specification, reflecting the imperfect state of the art and specifically the imperfect nature of cell separation techniques such as the FACS method, teaches that the disclosure concerning preparation of antibodies would enable the creation of only “relatively pure” stem cell suspensions. See ’680 patent, col. 4, 11. 55. Hopkins asserts that the highest disclosed purity for a stem cell suspension created by the disclosed technique, viz. 90%, see ’680 patent, col. 18, tbl. 9, should define the outer bounds of the words “substantially free.” Hopkins argues that CellPro’s proposed claim construction and citation from the prosecution history are inconsistent with Table 9, which describes small but measurable amounts of mature cells.
We agree with Hopkins that the district court’s construction of the words “substantially free” was not in error. Table 9, the only disclosed embodiment of the claimed cell suspension,
18
is highly indicative of the scope of the claims. A patent claim should be construed to encompass at least one disclosed embodiment in the written description portion of the patent specification. This maxim flows from the statutory requirement that “[t]he specification shall contain a written description of the invention,” 35 U.S.C. § 112, ¶ 1 (1994), which requires a patent applicant to disclose in the specification sufficient subject matter to support the breadth of his claim.
See Specialty Composites v. Cabot Corp.,
CellPro also notes that in response to the examiner’s request to clarify the “metes and bounds” of the words “substantially free,” the applicant, quoting the specification, noted that “[v]arious assay techniques have been employed to test for the presence of the My-10 antigen, and those techniques have not detected any appreciable number (i.e., not significantly above background) of normal, mature human myeloid and lymphoid cells in My-10-positive populations.” However, this passage does not describe the purity of a cell suspension produced by the disclosed technique, but rather describes the various species of cells that are present in “My-10positive populations,”
i.e.,
in populations which express the My-10 antigen. Thus, the quoted passage merely clarifies that a popu
*1356
lation of cells expressing the My-10 antigen contains no “appreciable number” of mature cells; it does not support the inference that such a population, when included with other mature cells and sorted according to the technique disclosed in the ’680 patent, can be sorted to recover only My-10-positive cells. Not only is this inference directly contrary to the reality of the cell suspension disclosed in Table 9, but it is also contrary to the expert testimony at trial which established that sorting techniques such as FACS suffer from “practical limitations” and are capable of producing cell suspensions of only 85-90% purity, the upper value of which is consistent with the district court’s construction.
See Hopkins I,
CellPro next calls attention to the prosecution history in which the applicant notes that “when My-10 + cells are incubated with a series of monoclonal antibodies which react with T-lymphocytes, no cells are found to be reactive.” Like the portion of the prosecution history cited above, this statement does not address the purity of a suspension produced by separation.
Finally, the applicant’s statement that “Bodger’s cell population has some T-cells present, but the present invention has none” does not support CellPro’s proffered construction. That the inventive cell suspension might contain no (or an immeasurable amount of) T-eells does not mean that the cell suspension does not contain measurable amounts of other mature myeloid-and lymphoid cells. Table 9 illustrates this point. Mature lymphocytes, of which T-cells are a subset, constituted a mere 1% of the stem cell suspension. However, other mature cells, including neutrophils (3%) and monocytes (6%), were also present in the suspension. See note 10, supra. In the end, it is unremarkable that the claims issued over Bodger, a reference which disclosed the use of an antibody that, unlike My-10, was specifically reactive with T-cells and consequently produced a cell suspension that was not substantially free of mature lymphoid cells. 19
Thus, none of the statements in the prosecution history that CellPro cites constitutes “highly persuasive” evidence to suggest that we should deviate from a claim construction that is required in order to encompass the only disclosed embodiment of a cell suspension in the ’680 patent. We therefore affirm the district court’s construction of the language “substantially free of mature lymphoid and myeloid cells” as requiring no more than 10% mature lymphoid and myeloid cells and its grant of JMOL in favor of Hopkins on the issue of literal infringement.
2. Obviousness/Anticipation
CellPro argues that it was error for the court, after granting Hopkins’ motion for a new trial on the issue of obviousness, to exclude the Morstyn reference as evidence of obviousness. CellPro asserts that it should not be held to have “waived” its right to rely on the Morstyn reference simply because it knowingly chose not to rely on Morstyn during the first trial. CellPro argues that Morstyn, which CellPro characterizes as enabling one of ordinary skill in the art to produce a stem cell suspension of 90% purity, did not become pertinent until after the first trial when the court adopted its “broadened” construction of the words “substantially free.” CellPro asserts that Morstyn, alone or in combination with Beverley, raises a genuine issue of material fact concerning- the validity of the claims of the ’680 patent and should have precluded summary judgment in favor of Hopkins on the issue of obviousness. Hopkins responds that CellPro waived its right to subsequently rely on Morstyn by virtue of its failure to include Morstyn in the final pretrial order pursuant to Fed.R.Civ.P. *1357 16(e). 20 Thus, according to Hopkins, the district court did not err in failing to consider invalidity arguments premised upon Mors-tyn.
We agree with CellPro that the district court erred in faffing to consider CellPro’s Morstyn-based invalidity challenge. The district court, when it construed the claims after trial, changed the rules of the game. Specifically, when the court rendered its claim construction of the words “substantially free” to encompass cell suspensions of at least 90% purity, new prior art became potentially relevant to the validity of those claims. CellPro was entitled to present this new art following the court’s grant of Hopkins’ new trial motion so that Morstyn could be evaluated on its merits. That CellPro knew of Morstyn before the first trial but chose not to rely upon it then cannot constitute a waiver to apply that art against a claim whose construction was not yet finally determined by the court.
Our conclusion is not altered by Hopkins’ “pretrial order” argument, because this argument has no merit. Nothing in Rule 16(e) indicates that a pretrial order from a first trial controls the range of evidence to be considered in a second trial. Indeed, such a cramped interpretation of Rule 16(e) would greatly hobble the parties from meaningfully relitigating an issue which the court has decided required retrial under Rule 59.
Accordingly, the court erred in determining that CellPro had waived its right to rely on the Morstyn reference to establish that the claims of the ’680 patent were either anticipated or would have been obvious to one of ordinary skill. 21 We therefore vacate and remand so that the Morstyn reference can be considered on its merits. 22
C. Validity and Infringement of the ’204. Patent
1. Claim Construction and Infringement
CellPro asserts that the district court erred in construing the “wherein” clause of the ’204 patent as referring to “the CD34 antigen.” CellPro contends that reference to “the CD34 antigen” was unnecessary and incorrect: it was unnecessary because the “wherein” clause clearly refers to a single antigen, the My-10 antigen, that is disclosed in the specification; it was incorrect, CellPro continues, because “CD34” refers to a genus of antigens and thus erroneously sweeps into the claims all CD34 antibodies, regardless whether they bind to the My-10 antigen. CellPro states that what the scientific community refers to as “the CD34 antigen” is in fact “a collection of different molecules, all based on the same protein backbone, [with] a number a molecular forms.” CellPro’s Opening Brief at 32 (quoting its expert’s declaration). Apparently CellPro considers these different molecules to be different antigens, because it explains that its 12.8 antibody binds to “a CD34 antigen” that is different from My-10. CellPro’s Reply Brief at 13 (emphasis added).
Significantly, Hopkins agrees with Cell-Pro that the claims cover a single antigen, not a genus of antigens, but contends that “the CD34 antigen” is an apt description of that claimed antigen. In support of its position, Hopkins points, inter alia, to the prosecution history. Specifically, Hopkins highlights the applicant’s reference during *1358 prosecution to the conclusion of the Third International Workshop on Leukocyte Differentiation (“Workshop”) and the applicant’s statement to the examiner that “[t]he antigen recognized by the monoclonal antibodies of this invention has been designated My-10 .,. by the inventor, and subsequently CD-34 (antibody cluster designation) by the [Workshop].” The Workshop’s report, also submitted by the applicant to the examiner, describes the antigen to which anti-My-10 is bound as “the CD34 antigen.” 23 In support of the district court’s grant of summary judgment of infringement, Hopkins points to several other pieces of documentary evidence in which CellPro admits either that its 12.8 antibody binds to “the CD34 antigen” or otherwise binds to the same antigen as anti-My-10. Thus, Hopkins contends that CellPro infringes the claims regardless whether the antigen of the claims is referred to as “the CD34 antigen,” “My-10,” or (to paraphrase the “wherein” clause) “the antigen bound by the antibody produced by the hybridoma on deposit.”
We agree with Hopkins that the district court’s claim construction was not in error. The district court may have been correct that it was “unorthodox” to condense the meaning of the “wherein” clause into the simpler language of “the CD34 antigen.” However, this treatment was not erroneous, as Hopkins’ citations from the prosecution history show; the applicant directly equated My-10 and thereby the entirety of the “wherein” clause with what the scientific community had come to understand as “the CD34 antigen.” Furthermore, the record makes clear that the term “the CD34 antigen” is synonymous with the antigen discovered by Civin.
CellPro cites no intrinsic evidence and no credible extrinsic evidence in support of its theory that “the CD34 antigen” encompasses a genus of antigens. Instead, what the evidence does show is that the CD34 antigen contains a number of epitopes 24 on its surface to which the various CD34 antibodies can bind. For example, the Workshop report explains that the various CD34 antibodies known as of that date all bind to the CD34 antigen, but to different epitopes, Joint App. at EA7275-82, and one study concluded that “at least three distinct CD34 epitopes” were expressed on the surface of the CD34 antigen, id at EA7283. The same conclusion is confirmed by CellPro’s own internal documents. For example, Dr. Berenson concluded that “[Antibody 12.8] recognizes the same antigen as does [anti-]My-10.... Unlike [anti-My-10], antibody 12.8 recognizes a distinct epitope that is also present on a similar population of marrow cells in nonhuman primates.” Id at A1390. Other evidence supports the conclusion that 12.8 and anti-My-10 bind to the same antigen, see id at A5846 (testimony of CellPro’s expert, Dr. D.R. Sutherland) (“So collectively we think that this data suggests that the [anti-]My~10 and 12.8 binding sites are distinct and nonover-lapping binding sites on the CD34 molecule.”); id at EA5462 (Bloomberg ’204 opinion letter) (“It is our understanding, based upon discussions with CellPro scientists, that the monoclonal antibody used by CellPro does not bind to the same epitope in the My-10 antigen as does the Civin anti-My-10 monoclonal antibody.”), and that this antigen is the CD34 antigen, see id at EA3781 (Cell-Pro’s FDA filing) (“The primary reagent is a monoclonal antibody (Mab) 12.8 which specifically binds to a unique antigen (CD34) on the target cells (stem cells).”).
CellPro cites no evidence to refute the clear conclusion to be drawn from these documents that its 12.8 antibody binds to the CD34 antigen, albeit to a different epitope than does the anti-My-10 antibody disclosed *1359 in the patent, and therefore literally infringes the claims of the ’204 patent. Accordingly, the district court’s construction of the “wherein” clause and its subsequent grant of summary judgment of infringement are affirmed.
2. Enablement
CellPro argues that the claims of the ’204 patent, which both parties agree are drawn to the genus of antibodies which bind to the claimed antigen, are not enabled as required by 35 U.S.C. § 112, ¶ 1, and that the district court erred in granting summary judgment to the contrary. CellPro contends that the patent discloses only the method of producing the anti-My-10 antibody and is therefore insufficient to enable one of ordinary skill in the art to make and use the broader genus of claimed antibodies.
See, e.g., Genentech, Inc. v. Novo Nordisk A/S,
Hopkins responds that the patent’s disclosed method of producing antibodies, the Kohler/Milstein method, has been used to produce over forty additional CD34 antibodies, and that most of these antibodies, including CellPro’s 12.8 antibody,
see Hopkins I,
When ruling on Hopkins’ motion for summary judgment of enablement, the district court was obliged to have viewed the evidence in the light most favorable to the nonmoving party, in this case CellPro, and to have resolved any evidentiary doubts in Cell-Pro’s favor.
See C.R. Bard, Inc. v. Advanced Cardiovascular Sys., Inc.,
Our review of the entire record leads to the conclusion that CellPro failed to raise a genuine issue of material fact concerning en- *1360 ablement, and therefore that the district court did not err in granting summary judgment. We consider each piece of CellPro’s evidence in turn.
CellPro first contends that Civin’s laboratory never again succeeded in producing another CD34 antibody using the technique disclosed in his patent specification despite a “major effort” on his part to do so. Howev-r er, as the district court noted upon granting Hopkins’ motion for a new trial on enablement, CellPro failed to offer evidence that many of those working on projects in Civin’s lab, including undergraduate students or others who had never before made a monoclonal antibody, were of ordinary skill in the art.
26
Hopkins I,
CellPro next contends that the testimony of its expert, Dr. D.R. Sutherland, raises a genuine issue of material fact concerning enablement. Sutherland testified that he was unsuccessful in making a CD34 antibody. However, and as the district court noted upon granting Hopkins’ motion for a new trial, Sutherland “did not use the screening technique disclosed in the specification” for identifying suitable hybridomas. Hopkins I, 931 F.Supp, at 323. A party who wishes to prove that the claims of a patent are not enabled by means of a failed attempt to make the disclosed invention must show that the patent’s disclosure was followed. Because Sutherland deviated from the teachings of the patent in his failed attempts to make the claimed antibodies, his testimony is insufficient to disprove enablement as a matter of law. 27
CellPro also cites the expert declaration of Dr. John Wij denes in an attempt to prove that the amount of experimentation needed to successfully practice the invention disclosed in the ’204 patent was undue. Although Wij denes concluded that it was generally “more difficult” for him to produce a CD34 antibody than other monoclonal antibodies, he did not attribute this difficulty to any shortcomings in the disclosure of the ’204 patent. Instead, Wijdenes’s declaration suggests that the Kohler/Milstein technique was not foolproof, and that success with this technique commonly required repetition. This lack of certainty was thus not attributable to a failure of disclosure in the ’204 patent. Such routine experimentation does not constitute undue experimentation:
The test [for undue experimentation] is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention.
PPG Indus., Inc. v. Guardian Indus. Corp.,
CellPro finally contends that no one ever succeeded in making CD34 antibodies using either purified My-10+ cells or immu-no-preeipitated My-10 antigens as the immu-nogens in the Kohler/Milstein method.
See Hopkins I,
In conclusion, our consideration of the record makes clear that CellPro has not raised a genuine factual dispute concerning the en-ablement of the claims of the ’204 patent. We therefore affirm the district court’s grant of Hopkins’ summary judgment motion on this issue.
3. Written Description
CellPro also asserts that the claims of the ’204 patent are invalid under § 112, ¶ 1, because they lack an adequate written description. Specifically, CellPro relies on
Regents of the University of California v. Eli Lilly & Co.,
We agree with Hopkins. Our review of the record shows that CellPro’s written description argument in the district court was premised on the argument that the claims of the ’204 patent would encompass monoclonal antibodies that bind to antigens on mature cells, but that the written description did not describe this aspect of the invention and in •fact expressly disclaimed an invention of such broad scope. See Joint App. at A19087.5, A19296-98. This is not the 14%-based written description argument that CellPro currently asserts on appeal.
CellPro also cites a document that it filed in the district court (only one page of which
*1362
is included in the appendix filed in this court) • in support of its contention that it raised a Lilly-based challenge in the district court.
See
Joint App. at A18371. However, in that page, CellPro merely mentioned the “genus-species” problem addressed by
Lillyin
a footnote; it did not make a serious Lilly-based argument as an alternative to its argument that the claims erroneously encompassed antibodies that bound to mature cells. Moreover, the main purpose of the document was to argue that the sufficiency of a written description under § 112, ¶ 1, is a question of fact. As a general rule, an appellate court will not hear on appeal issues that were not clearly raised in the proceedings below.
See Singleton v. Wulff,
D. Willful Infringement/Enhanced Damages
CellPro argues several points of error relevant to the district court’s decision to treble damages. We consider each of these arguments in turn, but are not persuaded that any reversible error has occurred.
CellPro contends that the jury’s finding of willfulness cannot stand because it is premised upon two errors committed by the district court. CellPro first asserts that the court erred in excluding from the jury evidence that CellPro had been wholly successful in the first trial, evidence that CellPro argues bears on the reasonableness of its actions. CellPro states that the test for willful infringement is “whether, ■ under all the circumstances, a reasonable person would prudently conduct himself with any confidence that a court might hold the patent invalid or not infringed,”
State Indus., Inc. v. Mor-Flo Indus., Inc.,
We agree with Hopkins that the district court did not abuse its discretion in excluding the existence of the prior liability verdict from the subsequent trial on willfulness and damages. First, as Hopkins notes and Cell-Pro does not dispute, CellPro had notice of the ’680 patent by 1989 and the ’204 patent by 1991. Because such notice placed upon CellPro on those dates the duty to exercise due care to determine whether or not it was infringing,
see, e.g., Kloster Speedsteel AB v. Crucible, Inc.,
CellPro also argues that the jury’s willfulness finding cannot stand because the jury insti’uctions erroneously mandated the jury to find that its infringement had been willful. CellPro points to the statements in the instructions to the effect that “no reasonable jury” could fail to find either that Cell-Pro infringed the ’680 and ’204 patents or that these patents were valid. CellPro contends that these statements, coupled with the court’s subsequent definition of willful infringement, i.e., “that the infringer had no reasonable basis for believing it had a right to engage in the infringing acts,” forced a finding of willful infringement, because, according to CellPro, if no reasonable juror could have reasonably found the patents invalid or not infringed, it would likewise necessarily have been unreasonable for CellPro to have had such a belief.
We do not accept CellPro’s argument. That no reasonable jury could fail to find that CellPro infringed valid patents says nothing about CellPro’s willfulness, a determination which is reflective of an infringer’s culpability.
See Rite-Hite Corp. v. Kelley Co.,
The Court thus determined that both the ’204 and ’680 patents are valid and infringed by CellPro. Accordingly, there are no issues for you to decide concerning CellPro’s liability for infringement of the ’204 and ’680 patents. In your deliberations you are bound to accept my determination that CellPro infringes these two patents, and that both patents are valid.
Joint App. at A26767. The jury instruction only separated considerations of liability and willfulness; we discern no error in that instruction.
CellPro next asserts that the court erred in failing to grant its renewed JMOL motion concerning willfulness. CellPro contends that a reasonable jury, upon consideration of its evidence, could not have found that its infringement was willful. Hopkins responds that the jury’s finding of willfulness was supported by substantial evidence.
Willfulness is a question of fact to be proven by clear and convincing evidence.
See SRI Int'l, Inc. v. Advanced Tech. Labs., Inc.,
Substantial evidence supports the district court’s conclusion that a reasonable jury could have concluded that the opinion letters were not adequate to defeat a finding of willfulness. Kiley, the CéllPro representative who procured the opinion letters from Bloomberg, was highly sophisticated in matters of patent law and in the involved technology. Kiley had worked as a patent examiner and later was a partner at the law firm of Lyon & Lyon, where he handled patent prosecution and patent litigation.
See Hopkins II,
CellPro’s final argument on willfulness is that the district court abused its discretion in deciding to treble Hopkins’ damages under 35 U.S.C. § 284. Although Section 284 does not state a basis upon which a district court may increase damages, it is well established that enhancement of damages may be premised upon a finding of willful infringement.
See, e.g., Beatrice Foods Co. v. New England Printing & Lithographing Co.,
CellPro’s argument does not take issue with the district court’s application of the
Read
factors. Instead, CellPro returns to its argument that the 1995 jury verdict reflects favorably on its lack of culpability because it illustrates the closeness of the case.
See
note 16,
supra
(fifth factor). We are once again not convinced that this temporary victory was significantly probative of CellPro’s lack of culpability during the early stages of its infringing activity. We believe that the district court adequately justified its decision to treble the damages.
See Hopkins II,
To summarize, we find no error in either the jury’s finding that CellPro willfully infringed the Civin patents or in the decision by the district court to treble damages; we accordingly affirm.
E. The Repatriation Order
CellPro’s final argument is that the court exceeded the scope of its power when it ordered the repatriation and destruction of the six vials that it exported to its business partner, Biomira, in Canada, as well as cloned vials and antibodies produced therefrom. CellPro contends that it has not committed an infringing act with respect to the exported vials. CellPro summarizes its activities as follows: it produced approximately 100 vials of 12.8 hybridoma to create a United States master cell bank prior to the issuance of the ’204 patent, it exported six of those vials to Canada after issuance, and it used those vials in Canada to supply markets outside of the United States. CellPro asserts that none of these acts—pre-issuance manufacture, export, or use outside of the United States—constitutes infringement under 35 U.S.C. § 271, and accordingly that such acts are beyond the scope of the court’s equitable powers.
Hopkins responds that the district court’s order was properly predicated on the determination that CellPro used (ie., by cloning or testing) other vials from its United States cell bank in the United States after the issuance of the patent and thereby infringed with respect to the United States cell bank “as a whole.” Hopkins asserts that the injunctive power of the district courts is not limited to the prohibition of those activities that constitute patent infringement, but also extends to prohibitions necessary in order to fashion a meaningful remedy for past infringement. Hopkins argues that repatriation in this ease is such a meaningful remedy and will prevent CellPro from unfairly capitalizing upon its infringement.
Section 283 of the Patent Code empowers the courts to “grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable.” 35 U.S.C. § 283 (1994). In accordance with the clear wording of this section, “an injunction is only proper to the extent it is ‘to prevent the violation of any right secured by patent.’ ”
Eli Lilly & Co. v. Medtronic, Inc.,
We agree with CellPro that the district court abused its discretion in ordering the repatriation and destruction of the exported vials. The repatriation aspect of the order does not enjoin activities that either have infringed the ’204 patent or are likely to do so and thus does not prevent infringement—the proper purpose of an injunction under Section 283. It is clear that the six vials standing alone have not infringed the ’204 patent. Mere possession of a product which becomes covered by a subsequently issued patent does not constitute an infringement of that patent until the product is used, sold, or offered for sale in the United States during the term of the patent.
See Cohen v. United States,
That CellPro used other vials from the cell bank in an infringing manner in the United States does not taint the six exported vials with infringement. 31 The exported vials were not “guilty by association.” One may consider the pre-issuance manufacture of two machines, one of which is used after the patent is issued and the other of which is exported. An injunction requiring return of the- exported machine, which was never made, used, or sold during the term of the patent in the United States, is beyond the scope of Section 283 and hence an abuse of discretion. The same principle applies here to the vials exported to Canada. Accordingly, the court’s conclusion that use of some of the vials of the cell bank constituted a use of the cell bank “as a whole” as a means of justifying its repatriation order was an abuse of discretion.
Moreover, there is also no evidentia-ry basis for concluding that the district court’s order was necessary to prevent Cell-Pro from committing further infringing activities. An injunction under Section 283 can reach extraterritorial activities such as those at issue here, even if these activities do not themselves constitute infringement. It is
*1367
necessary however that the injunctkm
prevent infringement
of a United States patent. For example, in
Spindelfabrik Suessen-
Schurr
v. Schubert & Salzer,
The record in this case does not, as in Spindelfabrik, suggest that the 'exported vials will be used in a manner which will infringe the patent. CellPro has stipulated, and Hopkins does not refute, that Biomira intended to produce antibodies for CellPro in Canada “for use in products to be sold outside of the United States.” CellPro’s Opening Brief at 40 (citing the declaration of John P. Bordonaro, at Joint App. A513, A515-16 (“At no time has CellPro imported back into the United States the 12.8 monoclonal antibodies manufactured by Biomira in Canada or the cell suspension derived from using the 12.8 monoclonal antibodies.”)). Because the record is devoid of evidence upon which the district court could have concluded that its order would prevent further infringement, there was no basis for the court to order the exported hybridomas and its byproducts to be shipped to the United States.
We also do not find persuasive Hopkins’ argument that the scope of the district court’s order can be justified because it is necessary to fashion a meaningful remedy for CellPro’s past infringement. Section 283 does not provide remedies for past infringement; it only provides for injunctive relief to prevent future infringement. The section under which a litigant must seek compensation for past infringement is Section 284.
See
35 U.S.C. § 284, ¶ 1 (1994) (“Upon finding for the claimant the court shall award the claimant damages adequate to compensate for the infringement.”). We do not understand Hopkins to seriously dispute that it has not received adequate compensation for Cell-Pro’s infringement. However, to the extent that Hopkins complains that CellPro’s infringement has damaged its ability to service foreign markets, Hopkins must rely on foreign patent protection.
See Deepsouth,
Hopkins further argues, mimicking the district court’s “as a whole” rationale, that it would be fair under the circumstances to order repatriation and destruction because CellPro has committed other clear acts of infringement with respect to other vials in the United States cell bank. We do not agree. As we have already stated, we disagree that this rationale provides a sufficient premise for the court’s order given the facts of this ease. Moreover, premising the order on this rationale amounts to punishment of CellPro for its infringement. This is not the proper purpose of injunctive relief under Section 283.
See Amstar Corp. v. Envirotech Corp.,
Those portions of the district court’s permanent injunction order that ordered repatriation and destruction of vials exported by CellPro to Biomira and byproducts produced thereby are not consistent with the stated purpose of Section 283—to prevent infringement. Thus, the court abused its discretion, and those portions of the order are vacated.
*1368 Both sides have raised further arguments in support of their various positions. We have considered all such arguments, but they do not alter our conclusions.
CONCLUSION
The court erred in concluding that CellPro waived its right to rely on the Morstyn reference in establishing that the claims of the ’680 patent are invalid under 35 U.S.C. § 103 (1994). We accordingly vacate the court’s grant of summary judgment in favor of Hopkins and remand for further proceedings on this issue. The court also abused its discretion in ordering the repatriation and destruction of vials of hybridoma which Cell-Pro exported to Biomira in Canada and byproducts thereof. We accordingly vacate these portions of the court’s permanent injunction order. The court did not err in any other respect. The decision of the court is therefore
AFFIRMED-IN-PART, VACATED-IN-PART and REMANDED.
Notes
. The written description portions of both patents' specifications are identical.
. The specification states that mature T-cells are a cause of GVHD in animals. See, e.g., '680 patent, col. 1, II. 36-37.
. "Monoclonal antibodies” are defined as "[a] population of identical antibodies ..., all of which recognize the same specific [epitope] on a simple or complex antigen.” Paul Singleton & Diana Sainsbury,
Dictionary of Microbiology and Molecular Biology
431 (2d ed.1993);
see also Hybritech, Inc. v. Monoclonal Antibodies, Inc.,
. Fluorescence-activated coating separation ("FACS”) "involves coating the antibody with a colored dye. All the cells in the coated sample then are passed through a machine that uses a laser to identify and separate the cells based on their color."
Hopkins I,
. A “hybridoma” is defined as "[t]he product and/or progeny of cell fusion ... between a [tumor] cell and a non-[tumor] cell; the in vitro production of hybridomas is carried out to provide continuously replicating (hybrid) cells which exhibit some or all of the characteristics of the non-[tumor] cell ...; such hybridomas are used, e.g., as sources of monoclonal antibodies.” Singleton & Sainsbury, supra note 3, at 562.
. Because the My-10 antigen disappears as a cell matures, but is present on all forms of stem cells, it is said to be “stage-specific,” not lineage dependent. See '680 patent, col. 4, 11. 43-48.
. Claim 1 of the ’204 patent contains several other limitations which describe, for example, the specific cells on which the antigen is present. As the parties have not brought these limitations to our attention, we presume that the parlies do not dispute that CellPro's antibody meets these limitations.
. As stated by the trial court, “CellPro’s process for purifying stem cells works as follows. Cell-Pro adds blood cells to some of the 12.8 antibody that has been previously bound to biotin. These cells are poured into a column, inside of which are beads covered with avidin. Avidin binds tightly with biotin, locking the [stem] cells onto the walls of the column while the other [mature] cells are washed away. The column is then agitated to loosen the [stem] cells to obtain a purified suspension of stem cells.”
Hopkins I,
. Apparently because neither CellPro's Ceprate machines nor its production of 12.8 antibody directly infringed the "cell suspension” claims of the '680 patent, Hopkins sued CellPro for inducing infringement and contributory infringement.
See Hopkins I,
. Table 9 indicates that "3% of the FACS-Sepa-rated My-10-antigen-positive cells were matured neutrophils ..., 6% were mature monocytes, and 1% were mature lymphocytes." '680 patent, col. 18, tbl. 9 n.*. Thus, there are 3% + 1% + 6% = •10% mature cells in the disclosed cell suspension.
"Neutrophils,” “monocytes,” and "lymphocytes” are defined as types of "leucocytes," which in turn are defined as "the white cells of the blood and lymphoid system.” Singleton & Sainsbury, supra note 3, at 498.
. Specifically, CellPro proffered two expert declarations, one from Dr. H. Mark Jones concluding that Morstyn anticipated the claims, and one from Dr. C. Glenn Begley concluding that the ■ claims were either "anticipated and/or obvious in view of [Beverly] and/or [Morstyn].”
. ' Although the court expressly rejected only Jones's testimony, we interpret the court’s reasoning to have precluded any argument that relied on Morstyn, including the argument that Beverly in combination with Morstyn would have rendered the asserted claims obvious.
On May 6, 1998, CellPro informed this court that, in response to the district court’s invitation, CellPro subsequently briefed the district court on the issue of admissibility of Jones’s testimony. After Hopkins had the opportunity to respond, the district court declined to reconsider its prior decision on this issue. See Johns Hopkins Univ. v. CellPro, Civ. No. 94-105-RRM (D.Del. Jan. 17, 1997) (transcript).
."CD” stands for "cluster designation," which is used by those skilled in the art to group together antibodies that exhibit similar binding characteristics, particularly binding to the same antigen. As explained by CellPro in its brief to this court: "[i]n an attempt to classify and to organize the large numbers of new blood cell antibodies that are generated in laboratories each year, panels of scientists review research data and designate clusters of antibodies that appear to have similar binding characteristics. CD34 is the 34th cluster so designated.” Cell-Pro’s Opening Brief at 5 n. 2. Thus, although "CD34” technically refers to a genus of antibodies that bind to a particular entity, scientists generally refer to that entity as "the CD34 antigen.” Both parties generally agree that the anti-My-10 and 12.8 antibodies have been properly classified as CD34 antibodies.
. The Kohler/Milstein method involves first immunizing a mouse with a human cell [the immu-nogen], which makes the mouse capable of producing the relevant antibody. The mouse's B cells, the ones that produce antibodies, are then removed and chemically fused with an immortal cancer cell line from a mouse. The fused cells, called hybridomas, will have the combined qualities of a B cell and the cancer cell line — they will be immortal and they will have the ability to make one antibody. The hybridomas are then screened to discover an antibody that has the characteristic being sought, in this case one that binds to an antigen on stem cells but not on mature cells.
Hopkins I,
. 35 U.S.C. § 284, ¶2 (1994) provides in relevant part that "the court may increase the damages up to three times the amount found or assessed” in a patent infringement action.
. These factors include: (1) whether the infringer deliberately copied the ideas or design of another, (2) whether the infringer, when he knew of the other's patent protection, investigated the scope of the patent and formed a good-faith belief that it was invalid or that it was not . infringed, (3) the infringer’s behavior as a party to the litigation, (4) the infringer’s size and financial condition, (5) the closeness of the case, (6) the duration of the infringer’s misconduct, (7) any remedial action by the infringer, (8) the infringer's motivation for harm, and (9) whether the infringer attempted to conceal its misconduct.
See Read,
. CellPro also notes that the applicant referred to this purported definition of the words "substantially free” during the reexamination of the '680 patent, at which time the applicant was attempting to distinguish its claims over the Beverley reference. Because the relevant excerpts from the reexamination prosecution history are largely redundant with the prosecution history summarized above, we do not reiterate them here.
. Hopkins intimates in its brief that the specification discloses other cell suspensions of lesser purities, but it has not specifically identified them and we do not find them in the specification.
. Equally unremarkable is the confirmation of the patentability of the claims during reexamination over the Beverley reference, which the applicant and the examiner agreed were "significantly contaminated with small lymphocytes,” including T-cells.
. "After [a pretrial] conference held pursuant to this rule, an order shall be entered reciting the action taken. This order shall control the subsequent course of the action unless modified by a subsequent order. The order following a final pretrial conference shall be modified only to prevent manifest injustice.” Fed.R.Civ.P. 16(e).
. We note that although the court granted a new trial on the issue of
obviousness,
it was not improper for CellPro to subsequently present an argument that the claims were
anticipated:
"[A] disclosure that anticipates under § 102 also renders the claim invalid under § 103, for 'anticipation is the epitome of obviousness.’ ”
Connell
v.
Sears, Roebuck & Co.,
. We express no opinion as to whether summary judgment may or may not be appropriate upon remand.
. Hopkins also points out that the examiner subsequently placed her imprimatur on the idea that My-10 and "the CD34 antigen” were synonymous, noting that the claims were limited to those monoclonal antibodies reactive with "a particular antigen (now identified as CD34).” See Joint App. at EA7954.
. An "epitope” is defined as “any region of the [antigen] macromolecule with the ability or potential to elicit, and combine with, specific antibody.” Singleton & Sainsbury, supra note 3, at 269, 323.
. The Kg-la cell line is a variant of the Kg-1 cell line.
See
'204 patent, col. 3,11. 44-47. Both of these cell lines and samples of the hybridoma produced thereby are readily available to the public, and the ’204 patent discloses the locations at which both of these starting materials may be procured. Such public deposits of living materials may enable a claimed invention whose manufacture or use depends thereupon,
see, e.g., Wands,
. The district court noted that ”[t]estimony at trial established that a person skilled in the art of making monoclonal antibodies must have a bachelor’s degree in the appropriate scientific field and must have made a monoclonal antibody at least once.”
Hopkins I,
. Dr. C.E. Van der School's expert declaration filed in opposition to Hopkins’ summary judgment motion is inapposite for the same reason. Van der School concluded "that there were numerous differences between [the] immunization protocol [which we] used to obtain three monoclonal CD34 antibodies . .. and Dr. Civin’s immunization protocol disclosed in the '204 pal- . ent." Joint App. at A23420. The deposition testimony of Dr. Gustav Gaudernack, also relied on by CellPro, evidences a similar failing to follow the disclosure of the '204 patent. Gauder-nack testified that he followed neither the disclosed immunization protocol nor the disclosed screening protocol. See id. at A22612.
. Wijdenes opined that the KG-1 and KG-la cell lines are equivalent immunogens for purposes of producing CD34 antibodies. See Joint App. at A23343.
. Finally, we note that Wijdenes, like Van der Schoot and Gaudernack, see note 27, supra, “did not copy the protocol described in [the '204 patent] specification,” Joint App. at A23361. This provides yet another reason for concluding that Wijdenes’s testimony did not bear significantly on enablement.
. In
Datascope,
the district court helped to justify its conclusion that the infringer did not act willfully by noting that this court had earlier split 2-1 in affirming the judgment that the infringer
*1363
was liable. The district court felt that this court’s non-unanimity buttressed "an honest doubt ... as to the validity and infringement of Datascope’s patents” as reflected in legal opinions which the infringer procured during the development of its infringing device.
Datascope,
The district court’s reference to this court’s 2-1 decision affirming the judgment of liability was inappropriate in this case. That decision was rendered several years after the date infringement began (i.e., the date employed in determining willfulness under the circumstances of this case), and was based on facts unrelated to [the infringer's] decision on the critical date.
Id.
at 828,
. We do not suggest, and neither party argues, that the court had no injunctive power with respect to those vials which were not exported but which were also not used in the United States. That these vials, like the exported vials, did not infringe does not free them from the court’s equitable power under Section 283. Because CellPro had used some of its vials in the United States, a clear act of infringement, its propensity to infringe has been sufficiently established such that the court could conclude that enjoining the use of United States-based vials was necessary to prevent infringement.