Citations

Full opinion text

MEMORANDUM AND ORDER

ROSENTHAL, District Judge.

The issues remaining in this case are the equitable defenses that the accused infringer, Trinity Industries, Inc., has asserted against the patentee, Kothmann Enterprises, Inc. (KEI). Trinity alleges that the claims of United States Patent No. 6,022,003 (the ’003 Patent) and United States Patent No. 6,505,820 (the ’820 Patent) are unenforceable because KEI and its predecessors engaged in inequitable conduct before the Patent and Trademark Office during the prosecution of both patents. In prior rulings, this court denied KEI’s application for a preliminary injunction, construed the patent terms, and denied motions for summary judgment on the equitable defenses. (Docket Entry Nos. 62, 90, 252). This court held a bench trial on the equitable defenses in May 2005. (Docket Entry Nos. 224-26). In an opinion issued in September 2005, this court ruled on the parties’ other summary judgment motions, holding that KEI owns both the ’003 Patent and the ’820 Patent; that the accused devices, Trinity’s MPS-350 and TRACC, do not infringe the asserted claims of the ’003 Patent or the ’820 Patent; and that the asserted claims of the ’003 Patent and the ’820 Patent are not invalid for lack of a written description or as anticipated by prior art. (Docket Entry No. 252).

Based on the record, the bench trial on the equitable defenses, the parties’ posttrial briefs, and the applicable law, this court now enters findings of fact and conclusions of law on Trinity’s claims of inequitable conduct and prosecution laches. This court does not find inequitable conduct as to the ’003 Patent. This court finds that although KEI used information obtained from this litigation in prosecuting the ’820 Patent and the ’755 Application, and that KEI delayed disclosing to the Patent Office the existence of the litigation and materials from the litigation, there is not clear and convincing evidence that the delay deprived the Patent Office of material information or was the result of an intent to deceive, so as to warrant a finding of inequitable conduct that would preclude enforceability. Finally, this court does not find prosecution delay that would preclude enforceability. This court orders the parties to identify any remaining issues or submit a proposed final judgment by January 27, 2006.

The findings and conclusions set out below explain the results reached. A detailed description of the patents in this suit, the accused devices, and the parties’ litigation history was included in this court’s September 30, 2005 Memorandum and Opinion. It is repeated here only when and as necessary.

I. Findings of Fact

A. Background

The application for what issued as the ’003 Patent was filed on November 7, 1994; the patent issued on February 8, 2000. On August 8, 2001, Kothmann and Kothmann, Inc. (“KKI”), KEI’s predecessor, filed this suit, alleging that Trinity’s MPS-350 and TRACC devices infringed claims 6, 8, and 12 of the ’003 Patent. (Docket Entry No. 1 ¶¶ 6, 9). The divisional application for what issued as the ’820 Patent was filed on October 1, 1999. That patent issued on January 14, 2003, subject to a terminal disclaimer. On that same date, KEI filed its first amended complaint in this lawsuit, asserting that Trinity’s MPS-350 and the TRACC infringed claims 6, 8, and 12 of the ’003 Patent and that the TRACC infringed claims 3, 4, 11, and 14 of the ’820 Patent.

In April 2002, this court held a four-day evidentiary hearing on KKI’s motion for a preliminary injunction. The parties presented evidence on infringement, validity, and enforceability. In September 2002, shortly before this court issued its ruling, KEI filed U.S. Patent Application No. 10/236,755 (“the ’755 Application”) as a continuation of the ’003 and ’820 Patents. In September 2002, this court denied KEI’s motion for a preliminary injunction. In detailed findings and conclusions, this court explained that KKI had not met its burden of showing a reasonable likelihood of success on the merits of its claim that the TRACC and MPS-350 infringed the asserted claims of the ’003 Patent. (Docket Entry No. 62).

In September 2003, after an evidentiary hearing, this court issued a Markman order construing the disputed terms of the ’003 Patent and the ’820 Patent. (Docket Entry No. 90). Within a few weeks, KEI filed a continuation application and claim amendments in the ’755 Application, adding language to address — and change — an aspect of the Markman ruling unfavorable to KEI’s infringement allegations in this suit, and disclosed the purpose to the examiner. In February 2004 and again in December 2004, the patent examiner issued notices of allowance of the pending claims in the ’755 Application. The ’755 Application was pending in May 2005 when this court held a bench trial on Trinity’s affirmative defenses of inequitable conduct and prosecution laches. (Docket Entry Nos. 229-31).

At the bench trial, this court heard testimony from Charles Rogers, a partner at Winstead, Sechrest, and Minick, P.C. who is one of KEI’s trial counsel of record in this case. Rogers is a member of the patent bar who specializes in litigating rather than prosecuting patents. He testified as to his role in the prosecution of the ’820 Patent Application and the ’755 Application. Henry Ehrlich, a partner at the same firm who was primarily responsible for the prosecution of the ’820 Patent Application and the ’755 Application, also testified as to his work. Two expert witnesses, Michael Sutton and Alan Gordon, both experienced patent lawyers knowledgeable about practice before the Patent Office, opined as to whether under the custom and practice of prosecuting patents, KEI violated duties of disclosing related litigation pending during a patent prosecution. Dr. Dean Sicking, one of the inventors listed on the patents at issue, also testified as to statements made in the ’003 Patent prosecution.

B. The Inequitable Conduct Assertions

In its posttrial brief, Trinity challenges two aspects of the prosecution of the ’003 Patent. First, Trinity asserts that the applicant misrepresented that it had tested the device claimed in a prior art reference, U.S. Patent No. 4,655,434 issued to Bronstad (the “Bronstad ’434 Patent”). Second, Trinity asserts that the applicant failed to disclose a separate patent application filed by Dr. Sicking pending before a different examiner. This separate patent application, which later issued as U.S. Patent No. 5,775,675 (the “Sicking ’675 Patent”), was filed after the ’003 Patent applicant had urged the distinction between “cutting” and “shredding” to overcome the examiner’s objection based on the Bronstad prior art reference. Trinity argues that in the ’675 Patent Application, Sicking had described the Bronstad device as “cutting” a guardrail, while in the ’003 Patent Application, Sicking described it as “shredding” and not “cutting.”

As to the ’820 Patent, Trinity asserts that KEI failed to disclose this litigation and certain information from this litigation during the prosecution of the ’820 Patent. Trinity also asserts that KEI delayed in disclosing the existence of, and information from, this litigation during the ’755 Application prosecution. This inequitable conduct allegation arises from what is described as a highly unusual circumstance: the simultaneous prosecution of a lawsuit alleging infringement of a parent patent (the ’003 Patent) and of an application for a divisional patent (the ’820 Patent). The unusual pattern continued in that before the divisional patent issued, a continuation application (the ’755 Application) was filed. When the divisional patent issued, it was added to the lawsuit as the basis for additional allegations of infringement. The expanded lawsuit based on the parent and divisional patents proceeded at the same time as the prosecution of the continuation application. The witnesses agreed that it is rare for litigation over a parent patent to be pending during the prosecution of a divisional or continuation patent. Rogers acknowledged that this case presented an “unusual” overlap between litigation and patent prosecution. Both Erlich and Rogers testified that they had never encountered a similar situation. (Tr. (Rogers) 384:16-385:8). The task before this court is to apply the rules governing disclosures to the Patent Office to this unusual factual context.

KEI has responded by accusing Trinity of engaging in inequitable conduct itself, resulting in unclean hands. KEI argues that Trinity failed to tell the Patent Office about this litigation and litigation it filed against KEI’s predecessors and Dr. Sicking in federal district court in the Eastern District of Texas, Beaumont Division, during the pendency of Trinity’s (or its licensor’s) prosecution of a patent application on an allegedly related device. In other words, KEI argues that Trinity engaged in conduct similar to the acts it alleges as inequitable when done by KEI. Trinity responds by arguing that KEI should not be able to present the evidence at all because it was not timely disclosed. Trinity also argues that the evidence is irrelevant because it concerns litigation that had a very different relationship to the patent application than the circumstances of this case. Because this court does not find inequitable conduct on the part of KEI, and because this court agrees that the circumstances involving Trinity’s patent prosecution were different from the circumstances at issue here, it is unnecessary to reach the allegation that Trinity engaged in similar conduct.

C. The Standard for Inequitable Conduct

Patent applicants have a duty to prosecute patent applications in the PTO with candor, good faith, and honesty. That duty requires applicants to disclose to the PTO: (1) information; (2) of which they are aware; (3) that is material to the examination of the application. Li Second Family Ltd. P’ship v. Toshiba Corp., 231 F.3d 1373, 1378 (Fed.Cir.2000); Ulead Sys., Inc. v. Lex Computer and Mgmt. Corp., 351 F.3d 1139 (Fed.Cir.2003). A breach of this duty, coupled with an intent to mislead, constitutes inequitable conduct. Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed.Cir.1995). If Trinity demonstrates by clear and convincing evidence that KEI withheld information material to the patentability of the ’003 and ’820 Patents and did so with deceptive intent, this court must then evaluate whether, on balance, that conduct rises to the level of inequitable conduct. “The more material the information misrepresented or withheld by the applicant, the less evidence of intent will be required in order to find that inequitable conduct has occurred.” Li Second, 231 F.3d at 1378. The adjudication of an inequitable conduct claim is an equitable determination, committed to the discretion of the trial court. Monon Corp. v. Stoughton Trailers, Inc., 239 F.3d 1253, 1261 (Fed.Cir.2001).

“Materiality” is defined in the Code of Federal Regulations. Information is material to patentability when:

[I]t is not cumulative to information already of record or being made of record in the application, and

(1) it establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or

(2) it refutes, or is inconsistent with, a position the applicant takes in:

(i) Opposing an argument of unpatentability relied on by the Office, or

(ii) Asserting an argument of patentability.

37 C.F.R. § 1.56(b) (2005). “A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in the claim its broadest reasonable construction ... and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.” 37 C.F.R. § 1.56. The Rule 56 standard is “a more objective standard than the reasonable examiner standard.” Dayco Prods., Inc., v. Total Containment, Inc., 329 F.3d 1358, 1363 (Fed.Cir.2003); see id. (discussing pre-1992 standard that defined information as material if “a reasonable examiner would have considered [the information] important in deciding whether to allow the patent application”); MPEP § 2001.04 (“[Section] 1.56 has been amended to present a clearer and more objective definition of what information the Office considers material to patentability.”). The Patent Rules expressly require disclosure of litigation pending during reissue or reexamination proceedings. 37 C.F.R. §§ 1.178, 1.56. No such express rule applies when, as here, litigation relating to a parent patent is pending during the prosecution of a divisional or continuation application.

The Manual of Patent Examining Procedure (MPEP) does not have the force of law, but contains instructions to examiners and provides information and interpretation. MPEP § 2001.06(e) states in relevant part, as follows:

Where the subject matter for which a patent is being sought is or has been involved in litigation, the existence of such litigation and any other material information arising therefrom must be brought to the attention of the U.S. Patent and Trademark Office. Examples of such material information include evidence of possible prior public use or sales, questions of inventorship, prior art, allegations of “fraud,” “inequitable conduct,” and “violation of duty of disclosure.” Another example of such material information is any assertion that is made during litigation which is contradictory to assertions made to the examiner. Such information might arise during litigation in, for example, pleadings, admissions, discovery including interrogatories, depositions, and other documents and testimony.

MPEP § 2001.06(c).

Inequitable conduct requires not only a knowing failure to disclose material information, but also a finding of deceptive intent. Catalina Lighting, Inc. v. Lamps Plus, Inc., 295 F.3d 1277, 1288 (Fed.Cir.2002). In the absence of a credible explanation, intent to deceive may be inferred from the facts and circumstances surrounding the knowing failure to disclose material information. Id. at 1289. “When balanced against high materiality, the showing of intent can be proportionally less.” Brasseler, U.S.A. I, L.P. v. Stryker Sales Corp., 267 F.3d 1370, 1381 (Fed.Cir.2001). “[If] withheld information is material and the patentee knew or should have known of that materiality, he or she can expect to have great difficulty in establishing subjective good faith sufficient to overcome an inference of intent to mislead.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1239 (Fed. Cir.2003).

In the context of an inequitable conduct determination, the “applicant” includes anyone under a duty to disclose material information and includes: the inventor, the prosecuting attorney or agent, and anyone associated with the inventor or the assignee who is involved in the preparation or prosecution of the application. Molins, 48 F.3d at 1178 n. 6. A finding of inequitable conduct during the prosecution of a related patent will result in the unenforceability of an independently-prosecuted patent when the inequitable conduct had a “direct effect” or “direct relation” to the relief the patentee seeks. See Consol. Aluminum Corp. v. Foseco Int’l Ltd,., 910 F.2d 804, 810 (Fed.Cir.1990). In cases involving related patents, courts have recognized “infectious unenforceability” when a related patent bears an immediate and necessary connection to the alleged inequitable conduct. See Mosaid Techs. Inc. v. Samsung Elec. Co., 362 F.Supp.2d 526, 553-34 (D.N.J.2005).

D. The Inequitable Conduct Allegations as to the ’003 Patent

Trinity argues that during the prosecution of the ’003 Patent, the applicant made a misrepresentation about testing performed using components disclosed in a prior art reference, the Bronstad ’434 Patent. Trinity also argues that the applicant failed to disclose a patent application by the same inventors in which they made a statement about the Bronstad prior art reference allegedly inconsistent with the statements used to overcome the same reference during the ’003 Patent prosecution.

1. The Alleged Misrepresentation About Testing

In August 1995, the patent examiner issued an office action on the ’003 Patent Application, rejecting claims 1 and 17 (and others) as anticipated by the Bronstad ’434 Patent. Those claims recited a “cutting means positioned to cut said guardrail.” The Bronstad ’434 Patent disclosed a guardrail system in which bolts progressively move through metal tabs separating slots in the guardrail as the impact head is pushed by an impacting vehicle. The system consists of a set of horizontally-overlapping guardrail sections with a series of closely-spaced slots. The guardrail segments are attached by bolts extending through the slots. When a vehicle impacts the nose of the terminal, the bolts are forced to move from one slot to the next, through the rail material between the spaced openings, in order to absorb the energy of the impacting vehicle. (Docket Entry No. 146, Ex. 5). During the ’003 Patent prosecution, the examiner stated that the Bronstad reference disclosed a “cutting means” cutting the guardrail, as claimed in the ’003 Application. In February 1997, the applicant filed an amendment in the ’003 Application to replace the claim term “guardrail” with the term “cutable member” and replace the term “guardrail system” with “energy-absorption system.” In response to the patent examiner’s anticipation rejection based on the Bronstad ’434 Patent, the applicant made the following argument before the PTO:

Bronstad discloses bolts in slots which are intended to split portions between a line of holes. Applicant does not believe, based on applicants testing, that those bolts will cut the guardrail but instead the guardrail fails by budding. At most, with small enough bolts, it may fracture pieces of the guardrail. Cutting means is not, using ordinary language of this art, readable on Bronstad’s bolts which are at best holding means which force compression and bending of the guardrail or fracturing of parts of it.

(D.Ex. 2, Tab.16, T01040). On March 17, 1997, the examiner responded as follows:

As concerns claim 17 Bronstad discloses an energy absorbing system .... including cutting means, splice bolts 50, positioned to cut the cutable member as the cutable member and cutting section are moved with respect to each other by the impact head.

(Id., Tab 17, T01058-59). On November 10, 1997, the applicant filed its Brief on Appeal and referred to “testing” a second time, as follows:

Claim 17 recites cutting means positioned to cut the cutable member. Bronstad discloses bolts in slots which are intended to split portions between a line of slots. Applicant does not believe, based on applicants testing, that those bolts will cut the guardrail but instead the guardrail fails by buclding. At most, with small enough bolts and small separating material, the separating material may fracture and break way. Cutting means is not, when using ordinary language of this art, readable on Bronstad’s bolts which are at best holding means which force compression and bending of the guardrail or fracturing parts of it.

(Id. Tab 24, T01115).

The PTO Board of Patent Appeals reversed the examiner’s rejection. The Board’s opinion stated in part as follows:

We agree with the appellants that the claimed “cutting means” is not readable on the bolts.... In that regard, the claimed “cutting means” must be given its broadest reasonable interpretation consistent with the specification, and must be read in light of the specification as it would be interpreted by one of ordinary skill in the art. In this case, the specification discloses (1) the cutters are wedge shaped, and (2) the cutters slice the rail [ ] with a “shearing” action. In our view, an artisan would readily recognize the basic difference between cutting as disclosed in this application and the shredding disclosed by Bronstad .... [T]he claimed “cutting means” is not readable on the bolts [ ] of Bronstad since the bolts [ ] will shred out rail material, not “cut” the rail material.

(Id., Tab 26, T01148-49 (internal citations removed)).

Trinity alleges that the applicant made an affirmative representation that it had tested the device claimed in the Bronstad prior art reference and argues that Sicking’s testimony during the bench trial supports a finding that he intended to deceive the PTO. Sicking testified that did a test using “rounded and blunted” blades similar to the rounded bolts disclosed in the Bronstad ’434 Patent, in a guardrail that would be used in the preferred embodiment of the invention claimed in the ’003 Patent. The guardrail he tested did not have the slots described in the Bronstad ’434 Patent guardrail. (Tr., pp. 178, 181-82). Trinity alleges that Sicking represented to the PTO that he had performed a test using not only a rounded piece meant to perform like Bronstad’s bolts, but also a guardrail that had the type of slots or tabs claimed by Bronstad. Trinity argues that because claim 17 of the ’003 Patent Application recited a “cutable member” rather than a “guardrail,” the “only” reasonable interpretation of Sicking’s statement about his testing is that the “guardrail” used in the test referred to the Bronstad guardrail, and that the examiner was led to believe that the applicant had tested Bronstad-type bolts in a Bronstad-type guardrail.

The words used in the challenged statements, taken in context, and Sicking’s testimony as to what he did in the test he described and why he described it as he did, do not provide clear and convincing evidence of a misrepresentation or intent to deceive. The original application for the ’003 Patent disclosed two “means” of cutting a “guardrail” and consisted of sixteen claims, including claims for a guardrail system. In 1995, the applicants had elected to pursue only the claims directed to a guardrail system. In the February 1997 amendment, the applicants replaced the claim term “guardrail” with the term “cutable member” and replaced the term “guardrail system” with the term “energy-absorption system.” The focus of the February 5, 1997 response to the examiner was on the rejection of claim 17. Sicking had responded to the examiner’s rejection of claim 1 by pointing out that as amended, it no longer recited “cutting means positioned to cut said guardrail,” but instead “recites cutting blades with the edges facing the guardrail.” (D. Ex. 2, Tab 16, T01039). Sicking emphasized that the Bronstad ’434 Patent disclosed bolts, not “cutting blades.” As to claim 17, the applicant again focused on the difference between the bolts claimed in Bronstad and the “cutting means” claimed in the ’003 Patent Application. The applicant noted that as amended, claim 17 recited “cutting means positioned to cut the cutable member.” The applicant pointed out that Bronstad “disclosed bolts in slots which are intended to split portions between a line of holes.” In the brief reference to “testing,” the applicant did not describe the method or means of the test, or the specific results. Instead, the applicant briefly stated a belief as to what the (undisclosed) results supported — that “these bolts” will not cut “the guardrail” but “instead the guardrail fails by buckling.” The applicant did not refer to bolts cutting “portions between a line of holes,” which is how it had just referred to what the Bronstad reference claimed, but instead used the term “guardrail.” The point was that the claimed “cutting means” did not read on Bronstad’s bolts, not that the “cutable member” did not read on the Bronstad claim of “slots separating a line of holes.”

The fact that Sicking used the word “guardrail” instead of “cutable member” in referring to the inference drawn from the testing results does not show an attempt to mislead the examiner into believing that the test used a Bronstad-type of guardrail as well as Bronstad-type bolts. The prior sentences did not use the word “guardrail” to describe either what the Bronstad ’434 Patent disclosed or what claim 17 of the ’003 Application disclosed. Sicking did not say that, based on his testing, he believed that the bolts would not cut the “cutable member.” Nor did Sicking say that he believed the bolts would not cut the “portions between a line of slots.” Instead, he used the general term, “the guardrail.” The ’003 Patent Application used the term “guardrail” frequently to refer to the preferred embodiment of the claimed invention. Had Sicking intended to mislead the examiner into thinking that he had tested a Bronstad-type of guardrail, he would more likely have used the same words he used to describe that guardrail in the previous sentence — “that those bolts will cut the ‘portions between the line of holes’ ” — rather than the term “guardrail.”

The reassertion of the testing reference in November 1997, after the examiner had maintained his position that as to claim 17, Bronstad’s bolts anticipated the ’003 Application because they were “cutting means positioned to cut the cutable member,” similarly does not support Trinity’s argument. Again, the applicant compared claim 17 to Bronstad without using the word “guardrail.” Again, the applicant did not describe the testing done, but only a belief as to how the bolts would perform based on (unspecified) results of the testing. Again, the applicant stated that based on the testing, it believed that “those bolts” — which had to be the Bronstad bolts, the only bolts described — would not “cut the guardrail.” To what does “the guardrail” refer? Trinity correctly points out that the applicant did not use the words “cutable member,” the words used in claim 17. But neither did the applicant use the words “portions between a line of slots,” the words used to describe the specific type of guardrail Bronstad claimed. Instead, the applicant used the term frequently used in the ’003 Patent Application — “guardrail”—to describe the preferred embodiment of the claimed invention.

The next page of the same appeal brief states: “Applicant believes that the guardrail of Bronstad may buckle under pressure, but could fracture the material between slots under some conditions.” As Sicking credibly testified at trial, he would not have said this so tentatively had he tested an actual Bronstad slotted guardrail. The sentence made clear’ that Sicking was not reporting on the specific results of a test on a Bronstad slotted guardrail.

The language the applicant used was, admittedly, neither precise nor precisely clear. The word “guardrail” can refer either to the preferred embodiment of the invention claimed in the ’003 Patent Application or to the specific type of slotted guardrail that Bronstad had claimed. Textual analysis does not support Trinity’s argument that the “only” reasonable interpretation is that the applicant was referring to a test on a Bronstad-type of guardrail. To the contrary, textual analysis at most reveals that the applicant used language that was imprecise. Sicking’s explanation of what he did and why he described it as he did is credible. This court does not find a knowing misrepresentation to the PTO.

Trinity argues that the examiner’s response showed his understanding that the applicant had tested a Bronstead-type of guardrail and that Sicking’s failure to respond at that point evidences an intent to mislead. The examiner’s response was imprecise as well: “[w]hether or not the configuration of Bronstad has passed the applicant’s own testing, the use of cutting means within guardrail terminals as a primary energy absorbing mechanism ... is considered previously known in the art.” (D. Ex. 2, Tab 25, T01139). It is unclear what the examiner believed the applicant had tested. The applicant’s failure to file an additional response further describing what it had tested or describing for the first time how it had conducted the test is not evidence of an intent to deceive. The examiner’s response does not clearly signal that the examiner had understood the applicant to say that it had tested Bronstadtype bolts in a Bronstad-type of slotted guardrail.

Sicking’s testimony at the bench trial was credible. He testified that he intended to tell the examiner that the Bronstad reference did not anticipate the invention claimed in the ’003 Application because the rounded bolts Bronstad disclosed would not have the effect Bronstad described in a guardrail without the slots Bronstad claimed. He did not intend to tell the examiner that he had tested a Bronstadtype of bolt on a Bronstad-type of slotted guardrail. Instead, he intended to tell the examiner that he had tested the Bronstadtype of bolts in a type of guardrail that would be used in an embodiment of Sicking’s claimed invention, not in a Bronstadtype of slotted guardrail. (Tr. T (Sicking) pp. 186:17-188:7). This explanation is consistent with the language used, although, as noted, that language is not precise.

The Federal Circuit has found inequitable conduct based on an applicant’s false representation that specific experiments were performed when such representations are made in response to invalidity positions taken by the PTO. See, e.g., Hoffmann-La Roche Inc. v. Promega Corp., 323 F.3d 1354, 1363 (Fed.Cir.2003); Purdue Pharma L.P. v. Endo Pharms., Inc., 410 F.3d 690 (Fed.Cir.2005). In Purdue, the Federal Circuit affirmed the trial court’s ruling that the patentee had committed inequitable conduct by misrepresenting that it had performed tests of its oxycodone product that showed more efficient pain control than prior art formulations. The examiner repeatedly rejected the claims in the application as obvious in light of prior art. In response, the applicant represented that it had discovered that its oxycodone formulation using a four-fold dosage range achieved the same clinical results as the prior art formulations using an eight-fold dosage range. At trial, the inventor testified that he had not obtained clinical evidence of the reduced dosage range and that the statement made to the PTO was based on his “insight” and knowledge of the pharmacological properties of the various elements in the formulations. The patentee had no clinical evidence supporting the statement when it was made or at any time before the patent issued. The trial court found that the patentee failed to disclose material information because it made repeated statements to the PTO that it had discovered a formulation for controlling pain that was much more effective than higher dosages of prior-art formulations, but it failed to inform the PTO that the “discovery” was based solely on the inventor’s “insight.” 410 F.3d at 694. On appeal to the Federal Circuit, the patentee argued that despite the absence of scientific proof for the “insight,” it had not stated that it had clinically tested the dosage ranges described, and therefore did not expressly misrepresent a material fact. The patentee also argued that the trial court erred in finding materiality because the examiner did not rely on the assertion about the four-fold dosage range results, and patentability did not depend on the presence or absence of scientific proof of a reduced dosage range. With respect to intent, the patentee argued error on the basis that it believed the assertions of more efficient pain control.

The Federal Circuit found that the trial court’s findings on materiality and intent were supported by the inventors’ testimony. The court explained that materiality does not require proof that the examiner relied on the statements in approving the claims. The court based the inequitable conduct finding on the patentee’s failure to tell the PTO that despite express references to tests that showed that a four-fold dosage range of the claimed formulation achieved the same clinical results as an eight-fold dosage range of the prior-art formulations, in fact, no tests had been performed at all.

In [.Hoffinann-La Roche ], the patentees had erroneously stated in the written description that a procedure had been performed and presented “results” of that procedure. This court affirmed the trial court’s finding of materiality, not on the ground that experimental results were required for patentability, but on the ground that patentees misrepresented the results and made reference to them during prosecution in responding to a PTO office action. Similarly, the trial court’s finding in this case was not based on Purdue’s failure to provide scientific proof of its “surprising discovery,” but on its claim to have made a surprising medical discovery without disclosing the evidentiary basis for it, i.e., that the alleged “discovery” under these circumstances was based on insight and was without an empirical basis.

Id. at 700 (citations omitted). “Information that Purdue’s assertion of a four-fold dosage range was based only on [the inventor’s] insight and not on experimental results was material because it was inconsistent with Purdue’s statements suggesting otherwise.” Id. at 699. The court stated that the requisite level of intent could be inferred from the statements, the context in which they were made, and the fact that the patentee had several opportunities to inform the PTO that it had performed no procedures that compared a reduced dosage range of the claimed formulation against a higher dosage range of the prior-art formulations, but instead continued to describe the “results” of nonexistent testing. Id. at 701.

Similarly, in Frazier v. Roessel Cine Photo Tech, Inc., 417 F.3d 1230 (Fed.Cir.2005), the Federal Circuit affirmed a finding of inequitable conduct based on the applicant’s submission of a video to show the patentability of the claimed lens system that contained footage shot with lenses other than those claimed in the patent application. After repeated rejections based on prior art, the applicant submitted the video “[i]n the interests of demonstrating to the Examiner the features and uniqueness of the optical system of this patent application.” Id. at 1233. In response to the defendant’s inequitable conduct claim, the applicant argued that the video was not material or misleading because the claimed lens was capable of producing the footage contained in the video. The court rejected the argument, explaining that the “numerous arguments directed to materiality overlook the fact that mere submission of the video with footage shot with other than the claimed invention constituted a sufficiently material misrepresentation without regard to whether the [claimed] lens could create the same shots.” Id. at 1235. The intent-to-deceive element was satisfied because the evidence showed that the applicant submitted the video to represent the capabilities of the claimed lens, knowing that portions of the video were shot with a different lens. Id. at 1236.

In these cases, the representations and information conveyed were clear and precise. The courts found inequitable conduct based on the applicants’ representations that they had performed experimental testing when they had not done so and that they had achieved test results that simply did not exist. In the present case, the evidence shows that the applicant did perform tests. The language used to describe what type of guardrail system was used in the testing was imprecise. The brief reference to tests is followed by an inference as to how the Bronstad rounded bolts would perform in comparison to the claimed “cutting means.” The imprecise nature of the reference to the testing, and Sinking's credible testimony as to the testing he did and what he intended to convey to the patent examiner, do not support a finding of either a misrepresentation or an intent to deceive. The statement about testing in the ’003 Application prosecution history does not amount to inequitable conduct.

2. The Alleged Inconsistency between Statements in the ’675 Patent Application and in the ’003 Patent Application

On April 2, 1997, Sicking filed the application for the ’675 Patent, which also discloses a roadside energy-absorbing safety device. The device claimed in that invention discloses “sequential kinking” as the energy-absorbing means of material deformation. (Docket Entry No. 162, Ex. 4) (“The impact energy is dissipated by the controlled kinking of the guardrail beams.”). The specification portion of that patent reads in part as follows:

Another treatment is the vehicle attenuating terminal (VAT), U.S. Pat. No. 4.655,434 (Bronstad). VATs consist of overlapped guardrail sections that have a series of closely spaced slots. The guardrail segments are attached by bolts extending through slots. When a vehicle impacts the end of this terminal, the bolts are forced to tear through the W-beam from one slot to the next. The W-beam segments are cut into several long ribbons as a impacting head is decelerated.

(Id., col. 1,11. 34-41) (emphasis added).

Trinity argues that the failure to disclose the use of the word “cut” in the ’675 Application to describe the Bronstad ’434 Patent is inequitable conduct because it is inconsistent with statements made in the ’003 Application about the Bronstad ’434 prior art reference. In the ’003 Application, the applicant stated that the Bronstad bolts did not operate by “cutting” or “shearing” rail material, but by “shredding” it. Trinity seizes on the use of the word “cut” in the ’675 Application as an admission that the blunt bolts in the Bronstad ’434 Patent “cut” the segments between the slots of the Bronstad guardrail. Trinity’s argument is unpersuasive. It ignores the sentence immediately before the sentence containing the word “cut.” That sentence states, “[w]hen a vehicle impacts the end of this terminal, the bolts are forced to tear through the W-beam from one slot to the next.” The word “tear” is consistent with the position the applicant took in the prosecution of the ’003 Application, that the Bronstad bolt did not shear or cut, but rather shredded, the material between the slots. The challenged sentence then describes what happens to the material between the slots after the bolts “tear through” the beam. That material is “cut into several long ribbons as an impacting vehicle is decelerated.” In the context of the prior statement that the bolts “tear through” the material separating the slots, this is not an admission that the material is sliced or sheared as opposed to shredded, which would have been inconsistent with the position taken in the prosecution of the ’003 Patent Application.

The description of the Bronstad ’434 Patent is virtually identical to descriptions that were in other Sicking patents disclosed to the examiner during the prosecution of the ’003 Patent. In the Sicking ’366 Patent, the Sicking ’928 Patent, and the Sicking ’016 Patent, directed to different guardrail terminals, there is a description of the Bronstad ’434 prior art. That description is set out below, with the differences between it and the description contained in the Sicking ’675 Patent italicized:

The guardrail segments are attached by bolts extending through slots. When a vehicle impacts the end of this barrier [rather than “terminal,”], the bolts are forced to tear through the W-beam from one slot to the next. As a result, the W-beam segments are cut into several long ribbons as a impacting head is decelerated.

The only relevant difference between the description of the Bronstad ’434 Patent in the Sicking ’675 Patent — which was not provided to the examiner during the prosecution of the ’003 Patent — and the description in the three other Sicking patents— which were provided to the examiner — is the absence of the words “as a result.” Sicking testified that he did not know why these three words were deleted from the description; his only explanation is that a different attorney wrote the descriptions. The salient question is whether the absence of those three words is a relevant difference. The answer to that question is “no.”

The description of the device claimed in the Bronstad ’434 Patent contained in the Sicking ’675 Patent was cumulative to information already before the examiner considering the ’003 Patent Application, because it is so similar to the descriptions contained in three other Sicking patents that were disclosed. The description is consistent with the position the applicant took in opposing the examiner’s arguments that the Bronstad ’434 Patent anticipated the ’003 Patent Application or in asserting arguments in favor of patentability. Additionally, the ’675 Patent was disclosed in the prosecution of the ’820 Patent Application and was not considered material. Given the disclosure of the three other Sicking patents with very similar language describing the Bronstad prior art reference, and given Sieking’s credible testimony as to the reason for the slight variation between that language and the language in the ’675 Patent, there is no basis to find that Sicking’s failure to disclose the ’675 Patent description of the Bronstad ’434 Patent was material or intended to deceive. This allegation does not provide a basis to find inequitable conduct as to the ’003 Patent.

E. The Allegations of Inequitable Conduct in the ’820 Patent Prosecution

Trinity alleges that KEI’s failure to inform the Patent Office of the existence of this litigation “in verifiable form” between August 8, 2001 and June 5, 2003, amounts to a failure to disclose material information under circumstances that show an intent to deceive. Trinity alleges that in addition to KEI’s failure to give written notice to the Patent Office of the existence of the litigation while the ’820 Patent Application was pending, KEI also failed to disclose or provide certain materials from the litigation that were material to the examiner’s consideration of the ’820 Patent Application. Trinity points to KEI’s delay in disclosing the litigation and in submitting materials from the litigation in the ’755 Application as evidence of a violation of the disclosure obligation and of an intent to deceive.

KEI responds by denying that it breached any duty to disclose material information. KEI asserts that in addition to believing that the Patent Office had the statutory notice filed by the Clerk’s Office of this litigation, Erlich gave oral notice of the litigation to the examiner in September 2001. KEI further argues that it disclosed all material information it learned as a result of the litigation to the Patent Office in a timely fashion. KEI uses the record as to the ’755 Application to argue that the fact that the examiner issued a third notice of allowance of the claims after receiving many of the filings from this litigation evidences that the filings were not material.

1. The Dispute as to the Legal Standard

The parties dispute whether the effect of section 2001.6(c) of the MPEP is to make the existence of litigation involving “the subject matter for which a patent is being sought” material as a matter of law. Trinity argues that the MPEP establishes the duty to disclose this litigation and makes that information material. KEI asserts that Rule 56, not the MPEP, controls the materiality determination.

The MPEP does not have the force of law or of the rules that govern patent litigation, but is “entitled to judicial notice as an official interpretation of statutes or regulations as long as it is not in conflict therewith.” Molins PLC v. Textron, Inc., 48 F.3d 1172, 1180 n. 10 (quoting Litton Sys., Inc. v. Whirlpool Corp., 728 F.2d 1423, 1439 (Fed.Cir.1984)). The MPEP states that the “existence of litigation” is material information in a prosecution of a patent involving the same “subject matter,” but does not state that all the litigation materials are material. The MPEP states that when the “subject matter” of a patent (or a patent that is sought) is involved in litigation, the existence of the litigation “and any other material information arising therefrom must be brought to the attention of the [PTO].” MPEP § 2001.06(c) (emphasis added). Courts have interpreted this language as meaning that the existence of litigation involving the same subject matter as a patent being prosecuted is “material” information. See DaimlerCkrysler AG v. Feuling Advanced Techs., Inc., 276 F.Supp.2d 1054, 1063 (S.D.Cal.2003); ICU Med., Inc. v. B. Braun Med., Inc., 2005 WL 588341 (N.D.Cal. Mar.14, 2006). This statement is, however, far from equating a failure to disclose that information to a finding of a breach of the duty of disclosure with intent to deceive. And this statement does not mean that all information or submissions filed in litigation are “material.”

A recent case involving inequitable conduct allegations arising from a failure to disclose litigation or litigation materials (that did not involve a reissue proceeding) is helpful because of the approach the Federal Circuit followed, although the opinion is unpublished. In Mallinckrodt, Inc. v. Masimo Corp. 147 Fed.Appx. 158, 2005 WL 2139867 (Fed.Cir.2005), the district court, then the Federal Circuit, examined allegations of inequitable conduct for failure to disclose related litigation during a patent prosecution under Rule 56. The courts analyzed whether the failure to disclose the existence of the patent infringement litigation and materials from that litigation during the prosecution of a patent application involving the same subject matter withheld information material to patentability, looking to Rule 56 for the definition of materiality. The courts then determined whether the failure to disclose the information was done with deceptive intent. Finally, the courts examined whether the conduct rose to the level of inequitable conduct. Neither the district court nor the Federal Circuit simply equated the failure to disclose the existence of related litigation or specific materials from that litigation to a breach of the disclosure duty. Instead, the courts analyzed the relationship between the patent involved in the litigation and the patent prosecuted before the Patent Office to determine whether the applicant failed to disclose information that was material under Rule 56 and, if so, the degree of materiality. That required an analysis of the extent to which the pending litigation affected the patentability of the invention claimed in the copending application. The degree of materiality in turn informed the analysis of whether the failure to disclose was accompanied by deceptive intent.

In Mallinckrodt, the Federal Circuit used the MPEP only to confirm the conclusion as to the materiality of undisclosed information reached by applying Rule 56. In applying the MPEP, the court did not merely examine whether the patent-in-suit and the patent-in-prosecution involved similar claimed inventions, but specifically analyzed the claim terms at issue in both the litigation and the patent prosecution to see whether and how the litigation affected the patentability of the invention claimed in the application. The court then conducted a balancing test to determine whether inequitable conduct had occurred. Mallinckrodt, 147 Fed. Appx. 158, 2005 WL 2139867, at **15-17. This approach is consistent with Rule 56 and the relationship of that rule with section 2001.06 of the MPEP.

2. The Evidence as to When and What KEI Disclosed to the PTO During the Prosecution of the ’820 Patent Application

A necessary first step in determining if there was a failure to disclose material information with the intent to deceive the examiner is to determine the timing and content of KEI’s specific disclosures to the PTO and the relationship of those disclosures to this litigation.

In August 1995, the patent examiner considering the ’008 Patent Application required the applicant to select one of four groups of claims that had been presented in the application filed in November 1994. The applicant elected to continue the examination of claims 1-5, which were directed to a guardrail system. The applicant later asked that the withdrawn claims, 6-16, remain for a later divisional application. On July 20, 1999, the PTO issued a notice of allowance on claims 17, 20, and 24, which later became the patent claims asserted in this infringement case. As issued, the claims described “[a]n energy-absorption system comprising: a terminal including an impact head; a cutting section; and a cutable member having an axis,” in which the cutting section included a “cutting means positioned to cut said cutable member as the cutable member and cutting section are moved with respect to each other by the impact head.”

On October 1, 1999, the application for the ’820 Patent was filed in the PTO as a divisional application of the ’003 Patent. If the applicant had waited three more months to file the divisional application, it would have been considered a reissue application, subject to rules targeted to reissue applications. The ’820 Application was, however, a divisional application. It reasserted the claims originally filed in the ’003 Patent Application that were withdrawn in response to the patent examiner’s 1995 restriction requirement. The ’820 Application had the same specification as the ’003 Patent Application. As originally filed, the “cutting means” limitation of the ’820 Application claims was in means-plus-function format.

In January 2000, the patent examiner provisionally rejected certain claims in the ’820 Application on the basis of “double patenting” and of anticipation in light of the Bronstad ’434 Patent. In February 2000, the ’003 Patent issued. In August 2000, after amendments were filed in the ’820 Application, the examiner issued a rejection for all but two claims as anticipated by the Bronstad ’434 Patent and as obvious in view of the Bronstad Patent and the Sicking ’366 Patent. These were the same prior art references the patent examiner had cited during the '003 Patent prosecution. In April 2001, the examiner allowed the two claims of the ’820 Patent Application.

On September 7, 2000, the patent attorney then prosecuting the ’820 Patent filed a request for continued examination, an amendment, and a terminal disclaimer voluntarily relinquishing any part of the term of the ’820 Patent that would extend past the expiration of the ’003 Patent. (Docket Entry No. 141, Ex. 10). The applicant stated that it would cancel the rejected claims to pursue them in a continuation application.

In September 2000, the UNL Board of Regents assigned the ’003 Patent and the ’820 Patent Application to ISC. After the assignment to ISC, Henry Ehrlich, a lawyer with Winstead, Sechrest, & Minick P.C. and a member of the patent bar specializing in patent prosecution work, took over as the lawyer prosecuting the ’820 Patent Application. In February 2001, the applicant filed a continuation application with an amendment putting claim 12— which eventually became ’820 Patent claim 1 — into independent form. The claim continued to recite a “means for cutting” along with a cutter holding section and a hollow receiving section.

On August 8, 2001, KE3 filed its original complaint and preliminary injunction application in this suit, asserting that Trinity’s MPS-350 and TRACC infringed the ’003 Patent. On August 29, 2001, Trinity filed its original answer and opposition to the motion for a preliminary injunction. That same day, Ehrlich filed an amendment in the ’820 Patent Application, leaving claims 12 and 13, which recited the “terminal” and “means for cutting the guardrail” limitations. The applicants made no disclosure of the existence of the infringement lawsuit. The Office of the Clerk of Court of the Southern District of Texas apparently did give the routine notice to the PTO of an infringement action involving the ’003 Patent, required under 35 U.S.C. § 290. The Clerk’s Office did not give notice when the ’820 Patent issued and allegations that it was infringed were added to this litigation. Whether or not the Clerk’s Office complied is irrelevant, however; the law is clear that the litigants’ duty of disclosure is separate from, and is not satisfied by, a report made under section 290. The duties imposed by 37 C.F.R. § 1.56(a) and MPEP § 2001.06(c) cannot be supplanted by the general administrative notice required by section 290. The MPEP imposes on the patent applicant an independent duty to disclose the existence of related patent infringement litigation. “[A]n applicant cannot assume that an examiner, however diligent and well-informed, will be aware of Section 290 notices in other patents. To do so would effectively eviscerate the duty of disclosure regarding related litigation owed to each patent examiner.” ICU Med., 2005 WL 588341, at *14.

On September 24, 2001, Trinity filed a response to KEI’s motion for a preliminary injunction in this lawsuit. In the response, Trinity asserted that the ’003 Patent was invalid on the basis of three prior art patents: U.S. Patent No. 3,777,-591 issued to Rands (the “Rands ’591 Patent”); U.S. Patent No. 3,782,505 issued to Armstrong (the “Armstrong ’505 Patent”); and U.S. Patent No. 3,428,150 issued to Muspratt (the “Muspratt ’150 Patent”). Erlich testified at the bench trial that after receiving information about Trinity’s response, he decided that KEI would file a continuation application and IDS in the ’820 Patent Application to disclose the prior art that Trinity had cited. Erlich testified that he telephoned the examiner to explain why he would be taking the unusual step in a divisional application of asking the examiner to consider all the claims' — even the two claims previously allowed in the April 2001 office action — in light of additional prior art references. Erlich testified that as part of the explanation he gave the examiner, he reported that the parent patent to the ’820 Patent Application was in litigation and that he had learned of new prior art references in the litigation. (Tr. (Erlich) 323:13-324:5). Although Erlich testified that he often made a written record of telephone calls to examiners, he did not do so in that instance. Erlich explained that his practice is to make a written record of telephone calls to an examiner that relate to changes to pending claims during a patent prosecution. (Tr. (Erlich) 273:14-19). The telephone conversation he had about the ’003 Patent infringement litigation, according to Erlich, dealt with the continuation application that asked the examiner to look at the claims — including previously-allowed claims — in light of newly-disclosed prior art references.

Rogers also testified that he understood that the Patent Office had been orally informed of the litigation well before any written notice was filed. Rogers testified that toward the end of 2001, he made sure that the patent office was made aware of the litigation during telephone conversations with Ehrlich, not because the litigation was “material,” but to explain where the additional, previously-undiselosed prior art was “coming from.” (Id., p. 396: 1-7).

Erlich and Rogers both testified as to the relationship of their work on the prosecution and litigation, respectively. Erlich had primary responsibility for the prosecution of the ’820 and ’755 Applications. Rogers’s focus was on the litigation, but he coordinated the litigation and the prosecution to make sure that KEI was taking consistent positions in both proceedings. (Tr. (Rogers) 416:2-11). Rogers was not listed as a prosecuting attorney on the ’820 Patent Application, but reviewed and drafted the claim correspondence and the amendments that Ehrlich submitted to the PTO. Rogers explained that he and Ehrlich “worked hard ... because we had the litigation going on at the same time as the patent application process, we worked hard to make sure there was nothing that could even be misconstrued as being inconsistent statements.” (Id., p. 416: 7-10). Rogers was also responsible for advising Erlich of information learned in the litigation that was material to the prosecution of the ’820 Patent Application and, later, the ’755 Application. (Tr. (Erlich) 283:9-14). Erlich testified that he was aware of the hearings in this case and this court’s rulings during the prosecution of the ’820 Patent and ’755 Application, but did not actually read any documents from this litigation. Neither Rogers nor Erlich discussed the claims in the ’820 Patent Application with Sicking or Pfeifer, the inventors of the ’003 Patent who were also listed on the ’820 Patent Application.

In the December 2001 filing, Erlich did not disclose the existence of the litigation in writing. On the same date, he filed an Information Disclosure Statement (“IDS”), disclosing eleven prior art references, including the Rands ’591 Patent, the Muspratt ’150 Patent, and the Armstrong ’505 Patent that Trinity had asserted as invalidating prior art in the ’003 Patent infringement litigation. Erlich also filed an amendment to change the means-plus-function limitation of a “means for cutting” to the structural limitation of a “cutter” and to delete the “terminal” limitation — both of which were present in the ’003 Patent claims — from the claims of the ’820 Patent Application. Trinity had asserted in this litigation that the “cutting means” limitation of the ’003 Patent claims was not present in either the MPS-350 or the TRACC and that the “terminal” limitation of the ’003 Patent meant that devices such as the MPS-350, which attach to the back of work trucks, did not infringe. Ehrlich testified about the December 2001 amendments, explaining that he amended the preamble of the claims from “guardrail terminal” to “energy absorption system” and as a result, he had to describe the “cutting section” in greater detail. He explained that he did not believe that “guardrail terminal” covered all of the embodiments that had been disclosed in the ’820 Application. (Id. (Erlich), p. 331, II. 4-7, 21-25). Erlich testified that it was his practice to avoid “means-plus-function” language and that he ordinarily would have changed the means-plus-function language in the ’820 Application. He and Rogers both acknowledged that they used information gathered from Trinity’s filings in this infringement suit in amending the ’820 Patent Application claims to delete the “means-plus-function” language, to change “cutting means” to “cutter,” and to delete the “terminal” limitation from the claims. Rogers testified that when Trinity raised “narrowing interpretations” of the ’003 Patent claims, he revised the claims in the pending ’820 Patent Application to broaden them to attempt to capture more of the originally-disclosed but unclaimed subject matter. “[I]n part through [Trinity’s] assertions in this case, we could figure out what those arguments would be that we had not fully claimed the full scope of the invention.” (Tr. (Rogers) 540: 16-25). In December 2001, when Erlich filed the continuation application, the IDS with the prior art references, and the amendments to the claims of the ’820 Patent Application, he did not disclose this ’003 Patent infringement litigation in writing, despite the fact that the source of the Rands, Muspratt, and Armstrong prior art references was Trinity’s submissions in this litigation and despite the fact that the change from “cutting means” to “cutter” and the deletion of the “terminal” limitation from the claims resulted in part from information obtained from Trinity’s filings in the litigation. (Tr. (Erlich) 330:20-331:4; Tr. (Rogers) 528:2-4).

This court held a four-day evidentiary hearing on the preliminary injunction application in April 2002. In that hearing, Trinity presented evidence supporting the arguments that the “cutting means” and “terminal” limitations in the asserted ’003 Patent claims meant that the MPS-350 and the TRACC did not infringe. By the time of the preliminary injunction hearing, KEI had amended the ’820 Patent A