In suit are United States Patent No. 4,944,308 issued July 31, 1990 (the '308 patent) and United States Reissue Patent No. RE 34,056 issued September 8, 1992 (the '056 patent), both entitled "Tissue Sampling Device." These patents originated with the work of Dr. Per Gunner Lindgren, a physician in Sweden, and are now owned by appellant C.R. Bard, Inc.

The patented inventions are devices for taking samples of body tissue for biopsy purposes, wherein a biopsy needle firing device or "gun" mechanically injects a biopsy needle assembly into the core body tissue. These devices are described as improving the speed, accuracy, ease, and patient comfort of tissue sampling, compared with manually inserted biopsy needles. They are said to be particularly advantageous for sampling small or movable lesions and fibrous or firm tissues, because the rapidly and firmly fired needles can penetrate even fibrotic lesions before the lesions can slip aside. The patented guns and needles have achieved commercial success.

Bard sued M3 Systems in August 1993 in the United States District Court for the Northern District of Illinois,1 asserting that M3's ProMag biopsy gun and ACN/SACN biopsy needle assemblies infringed the '308 and '056 patents, respectively. M3 raised the defenses that the patents are invalid on several grounds and are not infringed, and also charged Bard with fraud, antitrust law violation, and patent misuse. The jury rendered special verdicts in favor of M3 on every issue, finding the '056 patent invalid and not infringed on each of the grounds of anticipation, obviousness, violation of a section 102(b) bar, incorrect naming of inventors, and non-compliance with reissue requirements; and finding the '308 patent invalid and not infringed on grounds of anticipation, obviousness, and insufficient written description. The jury also found that Bard perpetrated fraud in the Patent and Trademark Office (PTO) in obtaining both patents, that Bard misused both patents, and that Bard violated antitrust law, awarding $1.5 million in antitrust damages, trebled by the district court.

The district court denied all post-trial motions. This appeal followed. This court affirms the judgment of invalidity of the '056 patent and vacates the judgment of noninfringement of the '056 patent. The judgment of invalidity of the '308 patent is reversed and the judgment of noninfringement is affirmed. The judgments of misuse and fraud are reversed. The judgment of antitrust violation on the ground of attempt to monopolize is affirmed, but the antitrust damages award is vacated, for redetermination upon remand.

The First Generation Device--The PCT Patent Application

In 1981 Dr. Lindgren, working in Sweden with Jan Allard, an engineer, designed and constructed the first of several successively improved mechanical biopsy guns. This "first generation" gun was designed to fire a commercially available biopsy needle assembly made by the Baxter Travenol Company, having the brand name "Tru-Cut." The Tru-Cut is a double needle consisting of a hollow outer needle called the cannula and an inner needle called the stylet. The stylet is solid except for a recess near its point. In the manual procedure for which the Tru-Cut was designed, the physician would first extend the stylet and insert the assembly into the body tissue, whereupon the tissue to be sampled would flow into the recess in the stylet; the physician would then push the cannula into the body tissue to surround the stylet and cut and trap the tissue sample in the recess.

This procedure required the physician to use both hands to manipulate the needles, while a second physician would hold and manipulate the ultrasound equipment that is usually required to view the interior of the body and direct insertion of the needles. Dr. Lindgren sought to mechanize this procedure in order to improve the speed and accuracy of insertion, to reduce human error, and to permit a physician to perform the biopsy without assistance by providing a sampling device that can be operated with one hand while the other hand holds the ultrasound apparatus.

The first generation gun is a box-like structure fitted with two spring-loaded drivers associated with slots that are configured to hold the cannula and stylet of the Tru-Cut needle assembly. To use this gun the physician must first "cock" each of the spring-loaded drivers. This cocking action, as it was often called at trial, is referred to as pre-tensioning or energizing in the patent documents. Cocking is performed by hand or with a specially designed tool described as a miniature crowbar. After the drivers are cocked, the stylet and cannula are placed in the appropriate slots and the gun housing is closed. The gun is then aimed at the target tissue and a trigger mechanism releases the stylet and cannula in rapid sequence. The needles are then manually retrieved.

Dr. Lindgren and Mr. Allard filed a patent application on the first generation gun under the Patent Cooperation Treaty (PCT). The invention was assigned to Radiplast AB, a small Swedish company associated with Dr. Lindgren. The PCT application was filed on March 31, 1982 and was published on October 13, 1983. It is prior art to the United States patents in suit.

The Second Generation--The '056 Reissue Patent

Starting in 1984, Dr. Lindgren undertook to improve the gun so that it would not be necessary for the physician to cock the two drivers manually before installing the biopsy needles, a step described as awkward and inefficient. In 1985 Dr. Lindgren, working with Dan kerfeldt, an engineer, designed a mechanism whereby the drivers are cocked by external action after the needles are placed in the gun and the housing is closed. In this mechanism rods are attached to each of the spring-loaded drivers, extend out the back of the gun, and culminate in a ring or handle. By pulling the ring or handle the operator simultaneously cocks both drivers, moving the needles rearward. A trigger mechanism then fires the stylet and cannula, in rapid sequence, into the tissue to be sampled.

The Tru-Cut needles were not usable with the second generation gun, for their structure was such that they could not be moved rearward as well as propelled forward. New needles were designed with a modified hub and flange structure and a slit in the stylet flange to facilitate placement in the gun. Corresponding structural changes were made to the gun to accommodate the changes in the needles. Radiplast, as assignee, filed a patent application in Sweden on February 19, 1986. The United States application was filed on July 30, 1986, naming Dr. Lindgren as the inventor. Corresponding United States Patent No. 4,699,154 (the '154 patent) was issued on October 13, 1987, with claims to the combination of the second generation gun and the new needle assembly. The '154 patent did not claim the needle assembly alone.

In 1989 Bard, having become Radiplast's distributor in 1987, acquired ownership of the Radiplast patents. Bard applied for reissue of the '154 patent in order to add claims to the needle assembly alone. This reissue patent issued on September 8, 1992, and is the '056 patent in suit. During the reissue proceeding Bard and Dr. Lindgren petitioned the PTO to correct the inventorship to include Dan kerfeldt. In addition, Bard described to the PTO various activities of Radiplast in the United States, as shall be discussed in connection with the on-sale issue.

Dan kerfeldt continued to work on improving these devices. He sought to make the gun easier to use, especially by inexperienced physicians. Because pulling the cocking ring required significant manual force to overcome the simultaneous resistance of both driver springs, he designed an external integrated cocking mechanism that energized the two springs sequentially, thereby requiring less force than did the simultaneous cocking mechanism of the second generation gun. The third generation gun also provided for separate rearward movement of the needles after the biopsy sample was taken, thereby facilitating removal of the tissue from the stylet. Radiplast applied for a United States patent on the third generation gun on November 14, 1988, naming Dan kerfeldt as inventor. The patent issued in 1990 and is the '308 patent in suit.

* VALIDITY OF THE '056 REISSUE PATENT

Bard charged M3 Systems with infringement of claims 9-12 and 21-23 of the '056 patent. M3 had the burden of establishing invalidity by clear and convincing evidence at trial. Carella v. Starlight Archery, 804 F.2d 135, 138, 231 USPQ 644, 646 (Fed.Cir.1986). On review, the appellate court must "decide for ourselves whether reasonable jurors viewing the evidence as a whole could have found the facts needed to support the verdict in light of the applicable law." Lemelson v. General Mills, Inc., 968 F.2d 1202, 1207, 23 USPQ2d 1284, 1288 (Fed.Cir.1992). The appellant must establish that the jury's actual or inferred factual findings were not supported by substantial evidence, or that the found or inferred facts were not sufficient to support the conclusion, or that the law was incorrectly applied. See, e.g., Applied Med. Resources Corp. v. United States Surgical Corp., 147 F.3d 1374, 1376, 47 USPQ2d 1289, 1290 (Fed.Cir.1998); D.M.I., Inc. v. Deere & Co., 802 F.2d 421, 425, 231 USPQ 276, 278 (Fed.Cir.1986).

When a claim or defense can not be maintained or defeated without a favorable finding on a material issue, and there is not substantial evidence supporting that finding, the verdict can not stand and the court must render judgment as a matter of law. See Fed.R.Civ.P. 50; Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 251-52, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); see generally Markman v. Westview Instruments, Inc., 52 F.3d 967, 975, 34 USPQ2d 1321, 1326 (Fed.Cir.1995) (in banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577, 38 USPQ2d 1461 (1996). The appellate court must determine whether on the evidence of record a jury might properly have returned a verdict in the non-movant's favor when the correct legal standard is applied. If not, the movant was entitled to have the question removed from the jury and decided as a matter of law.

We apply these principles to each of the grounds on which the jury rendered verdicts of invalidity of the asserted '056 claims. We direct our discussion of validity primarily to claim 21, for the claim is representative and M3 Systems' expert witnesses admitted infringement of claim 21 by M3's original ACN needles:

21. A biopsy needle for use with a tissue sampling device having a housing with a forward end, a first slide mounted for longitudinal motion within said housing, and a second slide mounted for longitudinal motion within said housing, said biopsy needle comprising:

a hollow first needle having proximal and distal ends;

a second needle extending through said hollow first needle and freely slidable therewithin, said second needle having proximal and distal ends;

a first head mounted to said proximal end of said hollow first needle, said first head including first flange means associated therewith for coupling said hollow first needle to said first slide for longitudinal motion both toward and away from said forward end of said housing; and

a second head mounted to said proximal end of said second needle, said second head including second flange means associated therewith for coupling said second needle to said second slide for longitudinal motion both toward and away from said forward end of said housing.

To meet the requirements of patentability a device must be new; that is, it must not have been previously known. Section 102(a) requires that the subject matter was not published anywhere, or known or used by others in the United States, before its invention by the patentee.2 An invention that does not meet the requirements of novelty in section 102(a) is said to be "anticipated."

When the defense of lack of novelty is based on a printed publication that is asserted to describe the same invention, a finding of anticipation requires that the publication describe all of the elements of the claims, arranged as in the patented device. Shearing v. Iolab Corp., 975 F.2d 1541, 1544-45, 24 USPQ2d 1133, 1136 (Fed.Cir.1992); Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed.Cir.1989); Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 894, 221 USPQ 669, 673 (Fed.Cir.1984). The jury found that all of the claims at issue were "fully anticipated by a single prior art reference." Bard states that no reference described the new biopsy needle assembly of the '056 patent, and that the closest prior art, which all agree is the Travenol Tru-Cut needle assembly, differs in material ways. M3 Systems states that the Tru-Cut (or a publication describing the Tru-Cut) anticipated the claimed needle assembly because the '056 claims, correctly construed, read on the Tru-Cut.

The district court declined to construe all of the claim terms that were placed in dispute, instructing the jury that "words in a claim are to be given their ordinary and accustomed meaning, unless it appears that the inventor intended to use them differently.... You may use the specification to interpret what the patentee meant by a word or phrase in a claim." The record shows that the court defined some terms and the parties explained their views to the jury. This procedure was not incorrect at the time this case was tried----for as the court observed, the question of the relative roles of judge and jury was then before the Supreme Court----and does not of itself warrant a new trial. On appellate review, however, we apply the principles of Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454-56, 46 USPQ2d 1169, 1172-75 (Fed.Cir.1998) (in banc), and determine whether on the correct claim construction the jury verdict can stand. See United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568, 41 USPQ2d 1225, 1236 (Fed.Cir.) (reviewing whether the verdict reached was in accordance with correct claim construction), cert. denied, --- U.S. ----, 118 S.Ct. 369, 139 L.Ed.2d 287 (1997).

1. The Term "Freely Slidable"

M3 Systems contends that the claim term "freely slidable" does not distinguish the '056 claims from the Tru-Cut needle assembly. The term "freely slidable" appears in the following claim clause:

a second needle extending through said hollow first needle and freely slidable therewithin, ...

Bard argues that the court should have construed "freely slidable" for the jury, and that correctly construed this term means that the needle slides freely in either direction. M3 responds that Bard improperly seeks to insert the limitation "totally" into the definition of "freely slidable" and that, correctly construed, "freely slidable" requires only sliding freely in the forward direction. M3 states that since the Tru-Cut is freely slidable in the forward direction, the claim reads on the prior art and is invalid for anticipation.

M3 Systems' proposed claim construction is not correct, and could not have reasonably been adopted. The specification leaves no uncertainty that the '056 needles are freely slidable in both directions, for that is a purpose of the new '056 needle structure. M3's proposed interpretation is unsupported by, and indeed is contrary to, the specification. See Slimfold Mfg. Co. v. Kinkead Indus., Inc., 810 F.2d 1113, 1116, 1 USPQ2d 1563, 1566 (Fed.Cir.1987) (claims are not interpreted "in a vacuum," but are read and understood in light of the specification of which they are a part). The jury's finding of anticipation can not be sustained if grounded on M3's interpretation of "freely slidable," for it was not disputed that the prior art Tru-Cut needles can not slide in both directions.

2. The "Housing"

M3 Systems argues that the preamble of the '056 claims refers only to the "housing" of the tissue sampling device, and that the lack of any preamble reference to an external automatic cocking mechanism invalidates the claims by anticipation because they fail to distinguish the gun of the preamble from the prior art first generation gun.

M3 Systems has incorrectly construed the claim preamble. A preamble may serve a variety of purposes, depending on its content. It may limit the scope of the claim, for example when patentability depends on limitations stated in the preamble, as in In re Stencel, 828 F.2d 751, 754, 4 USPQ2d 1071, 1073 (Fed.Cir.1987), or when the preamble contributes to the definition of the claimed invention, as in Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed.Cir.1995). In this case, however, the preamble simply states the intended use or purpose of the invention, as in Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 868, 228 USPQ 90, 94 (Fed.Cir.1985). Such a preamble usually does not limit the scope of the claim unless the preamble provides antecedents for ensuing claim terms and limits the claim accordingly. In Vaupel Textilmaschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d 870, 880, 20 USPQ2d 1045, 1053 (Fed.Cir.1991), for example, the preamble described a "reference point" that provided guidance in understanding and construing the claim.

In the case at bar, the preamble of claim 21 recites the portion and structure of the gun housing into which the needles fit, and provides reference points in the gun that aid in defining the needles as set forth in the body of the claim. M3 Systems is incorrect in stating that the preamble must contain details of the integrated mechanical cocking structure, for the gun structure is not part of the separate claims to the needles. The question of anticipation of the '056 claims relates to the needles, not the gun. To the extent that the jury verdicts of anticipation may have been based on M3's incorrect construction of the preamble, they can not be sustained. On the correct construction of the preamble, it contributes no basis of invalidity on the ground of anticipation.

3. The On-sale Bar and "Anticipation"

M3 Systems defends these anticipation verdicts by arguing that the asserted claims are anticipated because they are subject to an on-sale bar. Although 35 U.S.C. § 102(b) provides that an inventor's sales or offers of sale more than one year before the patent filing date may bar the grant of a valid patent,3 the on-sale bar is an independent ground of invalidity based on the inventor's delay in entering into the patent system. Although the on-sale bar can arise from one's own invention, "anticipation" does not arise from sale of one's own invention. We discuss the on-sale issue post; however, this aspect is unrelated to the "anticipation" verdicts, was not part of the jury instruction on that issue, and is not based on correct law.

In sum, M3 Systems directs us to no prior art or prior knowledge or use by others that constitutes substantial evidence of anticipation of the needles claimed in the '056 patent. M3's witnesses conceded that the '056 needles differ from the Tru-Cut in the flange structure for coupling to the gun for movement both toward and away from the housing, a structure that limits all claims, as well as in the additional limitation in claims 10 and 12 of a slit in the stylet head flange. It is not disputed that the Tru-Cut needle assembly lacks these elements. In view of these admitted differences between the '056 needles and the prior art, differences unambiguously stated in the '056 claims, the verdicts of anticipation are unsupported by substantial evidence. The judgment of invalidity on this ground is reversed.

Invalidity based on obviousness is a question of law based on underlying facts. See Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545, 148 USPQ 459, 467 (1966); Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566-68, 1 USPQ2d 1593, 1595-97 (Fed.Cir.1987). The relevant facts relate to (1) the scope and content of the prior art, (2) the level of ordinary skill in the field of the invention, (3) the differences between the claimed invention and the prior art, and (4) any objective evidence of nonobviousness such as long felt need, commercial success, the failure of others, or copying. Graham, 383 U.S. at 17, 86 S.Ct. 684, 148 USPQ at 467; see Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1270, 20 USPQ2d 1746, 1750-51 (Fed.Cir.1991).

The ultimate determination of obviousness vel non is a legal conclusion. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 297 n. 24, 227 USPQ 657, 667 n. 24 (Fed.Cir.1985). When a patent describes a new mechanical device that can be viewed as a new combination or arrangement of mechanical components, the legal conclusion of obviousness requires that there be some suggestion, motivation, or teaching in the prior art whereby the person of ordinary skill would have selected the components that the inventor selected and used them to make the new device. See Heidelberger Druckmaschinen AG v. Hantscho Commercial Prods., Inc., 21 F.3d 1068, 1072, 30 USPQ2d 1377, 1379 (Fed.Cir.1994) ("When the patented invention is made by combining known components to achieve a new system, the prior art must provide a suggestion or motivation to make such a combination."); Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 934, 15 USPQ2d 1321, 1323 (Fed.Cir.1990) (it is insufficient that prior art shows similar components, unless it also contains some teaching, suggestion, or incentive for arriving at the claimed structure). We review a jury verdict of obviousness to determine whether substantial evidence supports the factual findings predicate to the legal conclusion of obviousness and whether such findings can support the verdict, with appropriate consideration of the presumption of validity and the requirement that obviousness be proved by clear and convincing evidence; factual inferences are drawn and credibility determinations are accepted in favor of the verdict winner. See Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1480, 44 USPQ2d 1181, 1183-84 (Fed.Cir.1997); Structural Rubber Prod. Co. v. Park Rubber Co., 749 F.2d 707, 718-19, 223 USPQ 1264, 1273 (Fed.Cir.1984).

M3 Systems argued at trial that the patented needle assembly would have been obvious in light of the Tru-Cut needle assembly, and that the only differences arose from obvious adaptations to accommodate the new gun design and to provide the desired reverse movement of the needles. No other prior art was presented. The invention that was made, however, does not make itself obvious; that suggestion or teaching must come from the prior art. See, e.g., Uniroyal, Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1051-52, 5 USPQ2d 1434, 1438 (Fed.Cir.1988) (it is impermissible to reconstruct the claimed invention from selected pieces of prior art absent some suggestion, teaching, or motivation in the prior art to do so); Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1143, 227 USPQ 543, 551 (Fed.Cir.1985) (it is insufficient to select from the prior art the separate components of the inventor's combination, using the blueprint supplied by the inventor); Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549, 1556, 225 USPQ 26, 31 (Fed.Cir.1985) (the prior art must suggest to one of ordinary skill in the art the desirability of the claimed combination).

No prior art provided a teaching or suggestion or motivation that a needle assembly should be made with the structure shown and claimed in the '056 patent. Absent this essential evidentiary component of an obviousness holding, as a matter of law the verdicts of invalidity on that ground can not stand. Consequently, the judgment of invalidity based on obviousness is reversed.

The jury rendered special verdicts of invalidity of the asserted '056 claims on the ground of incorrect inventorship. Inventorship is a question of law, applied to relevant facts. Findings of relevant fact are reviewed on the standard appropriate to the trier of fact, in this case for substantial evidence. See Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980, 41 USPQ2d 1782, 1786 (Fed.Cir.), cert. denied, --- U.S. ----, 117 S.Ct. 2459, 138 L.Ed.2d 216 (1997). The application of law to the found or admitted facts is reviewed on appeal without deference to the trier of fact. See Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456, 1460, 45 USPQ2d 1545, 1547 (Fed.Cir.1998); Sewall v. Walters, 21 F.3d 411, 415, 30 USPQ2d 1356, 1358 (Fed.Cir.1994).

The "inventor," in patent law, is the person or persons who conceived the patented invention. Collar Co. v. Van Dusen, 90 U.S. (23 Wall.) 530, 563-64, 23 L.Ed. 128 (1874); Burroughs Wellcome Co. v. Barr Lab., Inc., 40 F.3d 1223, 1227-28, 32 USPQ2d 1915, 1919 (Fed.Cir.1994) ("Conception is the touchstone of inventorship.") Thus facts relevant to inventorship are those showing the conception of the invention, for others may provide services in perfecting the invention conceived by another without becoming an "inventor" by operation of law. Id.; Agawam Co. v. Jordan, 74 U.S. (7 Wall.) 583, 602-04, 19 L.Ed. 177 (1868); Hess, 106 F.3d at 980-81, 41 USPQ2d at 1786-87. As explained in Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624, 225 USPQ 634, 641 (Fed.Cir.1985), "an inventor may use the services, ideas, and aid of others in the process of perfecting his invention without losing his right to a patent."

An assertion of incorrect inventorship must be based on facts proved by clear and convincing, corroborated evidence. Hess, 106 F.3d at 980, 41 USPQ2d at 1786. The difficulty of determining legal inventorship has been recognized, see Jamesbury Corp. v. United States, 207 Ct.Cl. 516, 518 F.2d 1384, 1396, 183 USPQ 484, 489 (Ct.Cl.1975) (inventorship is one of the most difficult issues in American patent law) and, to avoid inadvertent invalidity, 35 U.S.C. § 256 permits correction of the designated inventorship of a patent when an error was made without deceptive intent:

§ 256 Whenever through error a person is named in an issued patent as the inventor, or through error an inventor is not named in an issued patent and such error arose without any deceptive intention on his part, the Commissioner may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.

See Stark v. Advanced Magnetics, Inc., 119 F.3d 1551, 1556, 43 USPQ2d 1321, 1325 (Fed.Cir.1997) (error in inventorship may be corrected at any time if no deceptive intent).

The '154 patent as filed in the United States had named Dr. Lindgren as sole inventor. In the course of the reissue proceeding Dr. Lindgren filed a petition in the PTO to add Dan kerfeldt as a joint inventor. Lindgren and kerfeldt each filed declarations explaining their roles in the invention and declaring that the omission in naming kerfeldt was due to differences between United States and Swedish patent law, and was not done with intent to deceive.

M3 Systems challenged the joint inventorship of Lindgren and kerfeldt, and also stated that neither one was an inventor of the '056 patent's needles, but that Alan Taylor, President of Hart Enterprises, the company Radiplast retained to manufacture its new needles in the United States, was the sole inventor. Although Mr. Taylor did not appear at the trial, he stated in a deposition that he was not an inventor, but that he suggested the slot in the stylet flange to cooperate with a guide pin in the gun and prevent rotation of the needle. He said he sketched his design for Mr. Engstrm, although such a sketch was not produced. M3 states that Mr. Taylor gave written notice of his claim in 1990, before the reissue application was filed, but the record citations in M3's brief do not direct us to such notice.

It has long been the rule that one who asserts "inventor" status must provide clear and convincing evidence of supporting facts, including corroborating evidence. See Woodland Trust v. Flowertree Nursery, Inc., 148 F.3d 1368, 1371, 47 USPQ2d 1363, 1366 (Fed.Cir.1998) (illustrating the historical distrust of uncorroborated oral testimony of prior invention and citing the "rule of reason" analysis of corroborating evidence in Price v. Symsek, 988 F.2d 1187, 1194, 26 USPQ2d 1031, 1036 (Fed.Cir.1993)). At the trial Mr. Engstrm disputed Mr. Taylor's statements, and the earliest depiction introduced of the flange with a slot was a Swedish document.

Alternatively, M3 Systems points to the design patents that were filed in the name of kerfeldt alone, as establishing that Dr. Lindgren was not a joint inventor of the needles with kerfeldt. Bard replies, and there is no dispute, that the design patents showed specific hub designs not shown in the utility patent. Whether kerfeldt was the sole inventor of specific hub designs does not negate his joint inventorship of the needles of the '056 patent, which are depicted and claimed broadly. Bard also stresses that if indeed there were error in inventorship, such errors are correctable and do not invalidate the patent absent deceptive intent. To invalidate a patent based on incorrect inventorship it must be shown not only that the inventorship was incorrect, but that correction is unavailable under section 256:

§ 256 [p 2] The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent in which such error occurred if it can be corrected as provided in this section....

Although M3 contends that deceptive intent can be inferred from the omission of Taylor as an inventor, precedent requires that one who claims a share of inventorship must establish that right by clear and convincing evidence. Ethicon, 135 F.3d at 1465-66, 45 USPQ2d at 1552; Hess, 106 F.3d at 980, 41 USPQ2d at 1785-86. Since such evidence was absent, the judgment of invalidity based on incorrect inventorship can not stand, and is reversed.

The jury also found by special verdicts that the asserted '056 claims were invalid on the ground that the reissue requirements were not met. M3 Systems explains in its brief that the jury found that "any purported error in the '154 patent could not be corrected by reissue," explaining that the errors were the error in inventorship and the error in failing to claim the needles in the original '154 patent.

With respect to the argument that the correction of inventorship was improperly made by reissue, we have been directed to no legal or procedural error, for the prosecution history clearly shows that the error in inventorship was described in the reissue application and corrected by appropriate petition, filed and processed while the reissue application was pending. A petition to correct inventorship, 37 C.F.R. § 1.324 (1991), may be filed during reissue proceedings. The error in inventorship was corrected before the reissue patent was granted, and thus the reissued patent names Lindgren and kerfeldt as the inventors. This procedure can not have provided ground for a reasonable jury's verdicts of invalidity based on violation of reissue requirements.

The other aspect that M3 Systems argued was not amenable to correction by reissue was the addition of claims to the needles per se. That argument incorrectly states the reissue law, for a primary purpose of the reissue statute is to enable the addition of claims to subject matter not claimed in the original patent. See Scripps Clinic & Res. Found'n v. Genentech, Inc., 927 F.2d 1565, 1575, 18 USPQ2d 1001, 1009 (Fed.Cir.1991) (purpose of reissue statute is to avoid forfeiture of substantive rights due to erroneously claiming less than entitled, through error without intent to deceive); In re Wilder, 736 F.2d 1516, 1518-19, 222 USPQ 369, 371-72 (Fed.Cir.1984) (purpose of reissue is to correct errors such as misunderstanding scope of the invention and claiming less than that to which the inventor was entitled).

M3 Systems states that since the needles were not claimed originally they were not "intended" to be claimed, and that absence of such intent is not an error correctable by reissue. That too is an incorrect statement of the law. An inventor's failure to appreciate the scope of an invention at the time of the original patent grant, and thus an initial intent not to claim the omitted subject matter, is a remediable error. See In re Amos, 953 F.2d 613, 619, 21 USPQ2d 1271, 1276 (Fed.Cir.1991) (reissue application not subject to rejection for failure to demonstrate initial intent to claim, when subject matter of reissue claims satisfies § 112 requirements); In re Weiler, 790 F.2d 1576, 1581, 229 USPQ 673, 676-77 (Fed.Cir.1986) ("intent to claim" is shorthand for a means of measuring whether required error is present); In re Hounsfield, 699 F.2d 1320, 1322, 216 USPQ 1045, 1048 (Fed.Cir.1983) (lack of "intent to claim" is only one factor to be considered).

M3 Systems also argues that the error in failing to claim the needles should have been corrected sooner. The reissue statute sets a two-year time limit for filing a broadening reissue application. This requirement was met. See 35 U.S.C. § 251; In re Graff, 111 F.3d 874, 877, 42 USPQ2d 1471, 1473-74 (Fed.Cir.1997) (broadened claims must be filed within two years); see also 37 C.F.R. § 1.175 (1991). There is no requirement that a patentee act earlier rather than later during the two-year window established by statute.

M3 Systems has stated no basis in fact or law for its assertion that any reissue procedure was violated. The verdicts of invalidity on this ground are unsupported in law, and judgment based thereon is reversed.

The jury also found that the asserted '056 claims were invalid on the ground that the new needle assembly had been "patented or published or in public use or on sale" in the United States more than one year before the filing date of the '154 patent application in the United States. See 35 U.S.C. § 102(b), supra note 3. Since that filing date was July 30, 1986, the critical date for bar purposes is July 30, 1985.

Although the special verdicts did not distinguish among the statutory grounds of patented or published or in public use or on sale, the major focus at trial and on appeal is the issue of on sale. While M3 Systems also argued that there was a bar based on publication and public use, the only evidence referred to relates to the first generation gun and the Tru-Cut needles, which are acknowledged prior art and are not claimed in the patents in suit. M3's argument at trial that these prior art devices were also a bar to the '056 claims under section 102(b) is not pressed on appeal.

The '154 and '056 patents are directed to the second generation gun and new needles. Before the critical date, indeed before the development of the second generation gun and new needles had been completed, Radiplast was engaged in a variety of activities directed to the United States market. These activities included demonstrating and promoting the first generation gun with the Tru-Cut needles, pursuing arrangements for clinical trials for the second generation gun and new needles through collaboration with a potential United States distributor, applying for FDA approval, arranging for manufacture of the needles in the United States, and related activities directed to commercial goals. Although Radiplast's final needle design was developed after the critical date, the issue at trial was the effect of these prior activities under the law of section 102(b).

Federal Circuit precedent on the on-sale bar requires consideration by the court of the totality of the circumstances in light of the various policies that underlie the bar. Precedent explains that "while a wide variety of factors may influence the on sale determination, no single one controls the application of section 102(b), for the ultimate conclusion depends on the totality of the circumstances." Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1566, 33 USPQ2d 1512, 1514 (Fed.Cir.1995); see Envirotech Corp. v. Westech Eng'g Inc., 904 F.2d 1571, 1574, 15 USPQ2d 1230, 1232 (Fed.Cir.1990).

Although a few cases have recognized the advantages of a bright line rule that would be applicable in all cases, that is, a defining event whereby an inventor will know when the bar will accrue, generally the court has undertaken to weigh the particular facts of the commercial activity against the particular policy considerations that apply to the situation, giving effect to the principle that "the policies or purposes underlying the on sale bar, in effect, define it." RCA Corp. v. Data General Corp., 887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed.Cir.1989). Thus, in general, "this court has been careful to avoid erecting rigid standards for 102(b)." Western Marine Elecs., Inc. v. Furuno Elec. Co., 764 F.2d 840, 844, 226 USPQ 334, 337 (Fed.Cir.1985); see Petrolite Corp. v. Baker Hughes, Inc., 96 F.3d 1423, 1425, 40 USPQ2d 1201, 1203 (Fed.Cir.1996) ("This court has emphasized that the totality of the circumstances must be considered in determining whether a particular event creates an on-sale or public use bar." (quoting U.S. Environmental Prods., Inc. v. Westall, 911 F.2d 713, 716, 15 USPQ2d 1898, 1901 (Fed.Cir.1990))).

The determination of whether a product was on sale in terms of section 102(b) is a question of law. See Micro Chem., Inc. v. Great Plains Chem. Co., 103 F.3d 1538, 1544, 41 USPQ2d 1238, 1243-44 (Fed.Cir.1997) (discussing precedent and applying the totality of the circumstances standard as a matter of law); KeyStone Retaining Wall Sys., Inc. v. Westrock, Inc., 997 F.2d 1444, 1451, 27 USPQ2d 1297, 1303 (Fed.Cir.1993) (explaining relevant factual inquiries); Baker Oil Tools, Inc. v. Geo Vann, Inc., 828 F.2d 1558, 1562-64, 4 USPQ2d 1210, 1213-14 (Fed.Cir.1987) (discussing various factors to be weighed in context of experimental testing by third persons).

The various policy considerations include the policy of providing a limited but normally sufficient time (one-year) for the inventor to test the commercial reception of the invention before deciding whether it warrants patenting; the policy of limiting the period during which the patentee may delay entering into the patent system for the purpose of deferring the end of the period of patent-based exclusivity; the policy favoring prompt public disclosure of inventions through the patent system; and the policy of recognizing the practical consideration whereby the value of an invention may not be known until it is publicly tested. Depending on the dominant policy considerations in the particular case, applied to the factual circumstances of that case, the Federal Circuit has reached a variety of conclusions as to when the on-sale bar arose. The court's precedent illustrates rulings ranging from the requirement that the patented product was produced and available commercially before the on-sale bar started to accrue, to rulings that the bar was triggered before the invention had been completed.

Before the critical date for the '056 patent, July 30, 1985, three sets of events were explored at trial. The facts are not in dispute; the question is whether, as a matter of law, the on-sale bar arose in these circumstances:

The clinical trials were arranged by American Pharmaseal, Radiplast's potential distributor in the United States, and were conducted in August and September 1985 (after the critical date) using the second generation guns and new needles. In January 1985 Thomas Engstrm of Radiplast had quoted to Pharmaseal the price for 12 guns and 500 needles for use in the trials. Pharmaseal later that spring requested 10 guns and 250 needles, for which Radiplast sent an invoice in June 1985. Mr. Engstrm testified that this payment was to defray some of Radiplast's costs in providing these devices, and was so understood. It was not disputed that the transaction produced no profit for Radiplast.

M3 Systems asserts that Radiplast sold the 10 guns and 250 needles to Pharmaseal, pointing out that a standard sales invoice was used. Bard replies that this was a transaction between collaborators, not a commercial sale and not a sale for commercial distribution. Dr. Lindgren testified that he visited the four United States hospitals that were testing the device (after the critical date), to explain its use and to see how it worked in different tissues, operated by different doctors. Bard stresses that the devices were not sold, that all but one were returned by the hospitals after the clinical trials, and unused needles were destroyed.

Generally cost defrayal arrangements between collaborators are not deemed to be invalidating sales, nor are payments for use substantially for test purposes. See In re Mahurkar, 71 F.3d 1573, 1577, 37 USPQ2d 1138, 1142 (Fed.Cir.1995) (actual sale of two prototype catheters "did not place the invention in the public domain or lead the public to believe that the device was freely available"); Ethicon, Inc. v. United States Surgical Corp., 762 F.Supp. 480, 506-07, 19 USPQ2d 1721, 1740 (D.Conn.1991) (clinical tests by surgeon not a public use under § 102(b)), aff'd, 965 F.2d 1065 (Fed.Cir.1992) (Table); Baker Oil Tools, 828 F.2d at 1564, 4 USPQ2d at 1214 (discussing factors in deciding whether the purpose of testing was primarily experimental). In its submissions to the PTO during the reissue proceeding Radiplast characterized the transaction concerning the 10 guns and 250 needles as for experimental purposes.

It is not disputed that the sole purpose of this transaction was to make the devices available to the four selected hospitals for a limited test period. Radiplast's arrangement with Pharmaseal for payment or defrayal of the cost of providing the devices was not a sale or offer of sale as contemplated by section 102(b). It contravenes none of the policies underlying the on sale bar for Radiplast to have recouped these costs. Upon considering the totality of the circumstances, I conclude that an on-sale bar did not arise based on this transaction between Radiplast and Pharmaseal in connection with the clinical trials.2. The Bulk Price Quotation

In January 1985 Radiplast quoted to Pharmaseal prices for various bulk quantities of up to 50,000 needles. At that time the new needles were still being modified, and the record shows that design changes were made well after January 1985. Mr. Engstrm of Radiplast testified that the quotation was information for a potential distributor, in the event that Pharmaseal accepted that role (it did not). The bulk price quotations were in a telex that stated, "This is to give you an indication of the price levels. We have to meet and discuss more in detail all things related with the marketing of our biopsy instrument in US." It was not disputed that the quotation was for modified needles, and that both parties understood that the modified needles were not yet available.

M3 Systems argues that since the first generation device had been shown to operate for its intended purpose using Tru-Cut needles, the inventor had already convinced himself that he had a satisfactory product that he wished to commercialize in the United States, and thus that the bulk price quotation, even if for needles not yet developed, was an on-sale event. M3 stresses that the price quoted for bulk quantities included a profit for Radiplast, unlike the price for the clinical trial quantities.

Quotation of a sales price to a potential distributor of a product that is not available for sale and distribution does not of itself establish an on-sale bar. See Continental Can, 948 F.2d at 1270, 20 USPQ2d at 1750 (price terms set between collaborators in joint research not an on-sale bar); Shatterproof Glass, 758 F.2d at 622, 225 USPQ at 639 ("clear weight of authority is that a bare offer to sell does not ipso facto satisfy the 'on sale' bar"). A primary policy served by the on-sale bar is to provide time for an inventor to determine the reception of his invention in the marketplace before entering into the patent system, while the one-year limit prevents undue lengthening of the period of exclusivity. The policy is served when cognizance is taken of whether the invention is ready for commercial use at the time that customer contacts are made. Although exceptions have arisen on particular facts, normally the on-sale bar does not accrue based on customer contacts made while the product is still being developed or tested. See KeyStone, 997 F.2d at 1451, 27 USPQ2d at 1303 (on-sale bar "requires that the device asserted to be on sale was operable"); Seal-Flex Inc. v. Athletic Track & Court Constr., 98 F.3d 1318, 1322, 40 USPQ2d 1450, 1452 (Fed.Cir.1996) (invention not completed if it required testing under conditions of actual use).

In this case, the circumstances of the incomplete stage of development of the second generation gun and proposed new needles at the time of this price quotation, the potential but not established distributor relationship underlying this quotation, the planned clinical collaboration, and the non-existence of a completed final product, negate the accrual of an on-sale bar from this price quotation. It seems clear that neither Radiplast nor Pharmaseal expected that this bulk price quotation would be followed by the placement of an order. To satisfy the on-sale requirement of section 102(b) there must be more than an informational exchange of price information, when there is no reasonable contemplation that the quotation will be followed by purchase and sale as a commercial transaction.

I conclude that the verdicts of invalidity based on the on-sale bar can not be supported by this bulk price quotation.

The third event raised by M3 Systems occurred in November 1984. Mr. Engstrm of Radiplast responded to a letter written in September 1984 by Dr. Phelps, a physician in Alabama, who had seen a demonstration and brochure for the first generation device and wrote to Sweden for information. Engstrm wrote back that he hoped to start marketing a second generation device and new needles in the United States in early 1985, and that if Dr. Phelps did not wish to wait until United States distribution was arranged he could order directly from Sweden; the letter quoted prices for a gun and needles. No further correspondence ensued. Dr. Phelps testified that he expected that had he sent an order it would have been filled, and that he knew nothing about the difference between "generations." Mr. Engstrm testified that neither the new needles nor the completed second generation gun was available when he answered Dr. Phelps.

An offer of sale originating in a foreign country, directed to a consumer in the United States, can establish an on-sale bar as to what was offered. In re Caveney, 761 F.2d 671, 676-77, 226 USPQ 1, 4 (Fed.Cir.1985). The demonstration and brochure that led to Dr. Phelps' inquiry were of the first generation device, which used Tru-Cut needles. Although the details of Radiplast's product changes were not explained to Dr. Phelps it was undisputed that an order, if placed, could not have been filled at that time with the second generation gun and needles. Cf. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed.Cir.1985) (finding it significant that purchaser could discern that it was the later-patented invention being offered for sale).

At the time of Mr. Engstrm's letter the second generation device and needles were in an early development stage. Although Dr. Phelps was not told the details of these developments, this correspondence did not raise an on-sale bar to a product not yet developed. As held in Robotic Vision Sys., Inc. v. View Eng'g, Inc., 112 F.3d 1163, 1167-68, 42 USPQ2d 1619, 1623 (Fed.Cir.1997), "subsequent completion of an invention after the critical date does not relate back to the date of an earlier alleged offer of sale." See also Micro Chem., 103 F.3d at 1544-45, 41 USPQ2d at 1243 (no on-sale bar when invention not completed at time of offer, only prototype and sketch of proposed configuration); Shatterproof Glass, 758 F.2d at 622, 225 USPQ at 639 (not an on-sale bar to solicit orders before invention completed); cf. Pfaff v. Wells Elecs., Inc., 124 F.3d 1429, 43 USPQ2d 1928 (Fed.Cir.1997), cert. granted, --- U.S. ----, 118 S.Ct. 1183, 140 L.Ed.2d 315 (1998) (No. 97-1130) (although invention not reduced to practice because no physical embodiment had been made, the firm purchase order and delivery date accrued the on-sale bar) (citing UMC Elecs. Co. v. United States, 816 F.2d 647, 2 USPQ2d 1465 (Fed.Cir.1987)). On the totality of the circumstances, considering the relevant policies and the undisputed facts, I conclude that this letter to Dr. Phelps, written in response to an inquiry about the first generation device, which resulted from a brochure on the first generation device, stating the price for the second generation device and needles before they were fully developed and before they were available, did not trigger the on-sale bar.

Upon de novo review of the totality of the circumstances, with due consideration to the applicable policies, the undisputed facts, and drawing factual inferences in favor of the verdicts, I conclude that the verdicts of invalidity based on a section 102(b) bar are incorrect; I would reverse the judgment on that ground.5

In view of the majority's affirmance of the judgment of invalidity, we do not reach the issue of infringement of the '056 patent. That judgment is vacated.III

The '308 patent is directed to the third generation gun. The jury found the asserted claims of the '308 patent not infringed, and invalid or unenforceable on the grounds of anticipation, obviousness, and insufficient supporting description, as well as for fraud, misuse, and violation of antitrust law, as discussed in Parts V-VII, post.

Claims 15 and 16 were at issue, with emphasis added to show the claim terms whose construction is relevant to the issues of patent validity or infringement:

a guide sleeve having front and rear guide sleeve ends and defining a longitudinal axis extending between said front and rear guide sleeve ends, said front guide sleeve end having an opening therethrough;

a hollow first needle positioned within said guide sleeve and extendable from said opening, said hollow first needle being moveable along said axis;

a second needle extending through said hollow first needle and moveable along said axis, said second needle having a tip which is extendable from said hollow first needle and said opening, and said second needle further including a tissue sample receiving recess;

a first needle head coupled to said hollow first needle and mounted within said guide sleeve for movement along said axis to move said hollow first needle along said axis;

a second needle head coupled to said second needle and mounted within said guide sleeve for movement along said axis to move said second needle along said axis;

a first spring disposed within said guide sleeve and operatively associated with said second needle head, said first spring being capable of being placed into an energized mode to store energy, and said first spring being releasable from said energized mode to propel said second needle head along said axis towards said opening, such that said tip of said second needle is extended from said hollow first needle, whereby a tissue sample can be captured within said recess;

a second spring positioned within said guide sleeve and operatively associated with said first needle head, said second spring being capable of being placed into an energized mode to store energy, and said second spring being releasable from said energized mode to propel said first needle head along said axis towards said opening, said hollow first needle being extended from said opening such that said recess of said second needle is enclosed by said hollow first needle;

a first latch means selectively releasable from outside said guide sleeve for releasably holding said first spring in said energized mode;

a second latch means for releasably holding said second spring in said energized mode, said second latch means being releasable in response to and subsequent to release of said first spring; and

sequential energizing means operative to move said first needle head along said axis towards said rear guide sleeve end to cause said second latch means to hold said second spring in said energized mode, and subsequently to move said second needle head along said axis towards said rear guide sleeve end to cause said first latch means to hold said first spring in said energized mode.

Claim 16 is the same as claim 15 except for the last clause, which includes the selective retraction of the stylet to expose the tissue sample:

16..... energizing means operative to move said first needle head and said second needle head along said axis towards said rear guide sleeve end to cause said first latch means to hold said first spring in said energized mode and to cause said second latch means to hold said second spring in said energized mode, said energizing means being selectively operative to move said first needle head but not said second needle head towards said rear guide sleeve end, whereby said hollow first needle is selectively retractable to expose said tissue sample receiving means in said second needle.

The jury found claims 15 and 16 "not supported by the description contained in the specification." M3 Systems explains that the issue was the meaning of the claim terms "sequential energizing" and "energizing means." The district court had permitted the jury to resolve this disputed issue of claim construction. On this appeal we give de novo review to the issues relevant to the construction and interpretation of the claims. See Cybor, 138 F.3d at 1454-56, 46 USPQ2d at 1172-75.

M3 Systems states that "sequential" should be construed, and was construed by the jury, to permit no overlap of needle movement during the energizing step. M3 states that since the patent shows that the second needle can start to move before the first needle has completed its movement, the written description does not support the claims. M3 states, as it did at trial, that since the specification does not describe how to obtain elimination of all overlap of needle movement, the claims are not supported by the written description and are invalid.

Bard agrees that the specification shows a slight overlap in the movement of the needles, whereby the second needle starts to move just before the first needle has completed its movement and the first spring latches. Thus, Bard contends, correct interpretation of the claims allows for this slight overlap in needle movement. Bard states that it is incorrect to construe the claims contrary to the specification, and then to hold the claims invalid because they are contrary to the specification. Bard is of course correct; the claims are construed in accordance with the rest of the specification of which they are a part, and not contrary to it. See Slimfold Mfg., 810 F.2d at 1116, 1 USPQ2d at 1566; SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1125, 227 USPQ 577, 585 (Fed.Cir.1985) (in banc).

The specification illustrates the sequential energizing of the needles as having some overlap in movement of the needles. The term "sequential" in the claims is in accordance with this description in the specification; no usage or exemplification of the sequential movement requires eliminating all overlap. It is incorrect to construe the claims as barring all overlap, as urged by M3 Systems. On the correct claim construction, no reasonable jury could have found that the claims are not supported by the description in the specification. It is thus apparent that the jury either adopted M3's erroneous claim construction, or incorrectly applied the law governing claim construction to the undisputed facts of the structure described in the specification.

On the correct claim construction the written description is in accordance with and in support of the claims. The judgment of invalidity on this ground is reversed.

The jury also found claims 15 and 16 invalid based on anticipation. "Anticipation" requires that the identical invention was already known to others, that is, that the claimed invention is not new. See Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1572, 24 USPQ2d 1321, 1332 (Fed.Cir.1992) ("In order to anticipate, the [reference] must sufficiently describe the claimed invention to have placed the public in possession of it.") M3 Systems argued that anticipation arose on the published PCT application describing the first generation biopsy gun, and on the device itself. It was not disputed, however, that the first generation gun lacks the integrated mechanical energizing structure described and claimed in the '308 patent, and that the PCT application does not show such structure.

M3 Systems' argument was that when the claims are correctly construed they are anticipated. M3 states that on the claim construction reached by the jury in finding claims 15 and 16 unsupported by the written description, whereby the term "sequential" is defined as barring all overlap in needle movement, the structure in the specification is inconsistent with the claims and therefore must be disregarded. M3 argues, as we understand it, that since "energizing means" and "sequential energizing means" are in means-plus-function form, it is appropriate to disregard the structure in the specification that is inconsistent with the claim language, leaving the claimed functions with "no disclosed supporting structure," quoting from M3's brief. Thus, according to M3, these claim terms are directed only to function, and can be anticipated by any prior art that shows the function of energizing or sequential energizing, without limit to how that function is performed. Thus M3 argues that since the PCT application and the first generation gun are manually sequentially energized, one spring at a time, the jury correctly found anticipation by the first generation gun and the PCT application.

Indeed, the jury verdicts can be understood only if one adopts so tortured a view of the law. As we have discussed, it is incorrect to construe claims contrary to the specification, and it is incorrect to construe terms in means-plus-function form as disembodied from the structure in the specification. M3 Systems' witnesses readily admitted that the integrated mechanized gun described and claimed in the '308 patent is different from the first generation gun and the description of that gun in the PCT application. On the undisputed facts and the correct law, a reasonable jury could not have found the '308 claims anticipated thereby. The judgment of invalidity for anticipation must be reversed.

M3 Systems argues that the third generation gun of the '308 patent would have been obvious in view of the PCT application and the first generation gun, in combination with the '154 patent describing the second generation gun. M3 states that the third generation is an obvious combination of elements found in the first and second generations. See discussion, Part I.B. ante, of the law of obviousness. There was no dispute as to the scope and content of this prior art, or as to the elements in the third generation gun that were not in either the first or second generations. The only dispute was the ultimate question of whether the third generation gun would have been obvious from what had gone before.

M3 Systems contends that for the third generation the inventor simply changed the integrated mechanical cocking mechanism of the second generation gun to accomplish mechanically the sequential cocking that was necessarily done when the first generation gun was manually cocked, one spring at a time. Bard replies that the one-at-a-time cocking of the springs in the first generation, by hand or by miniature crowbar, does not teach or suggest the integrated automatic sequential cocking of the third generation, and that there is no teaching or suggestion in the prior art to make such a combination, or of the structure having the improved ease of handling of the third generation gun. Bard also points to the other new structural features of the third generation whereby the needles can be retracted separately after tissue sampling.

The ultimate question is whether, from the evidence of the prior art and the knowledge generally available to one of ordinary skill in the relevant art, there was in the prior art an appropriate teaching, suggestion, or motivation to combine components in the way that was done by the inventor. See, e.g., Uniroyal, 837 F.2d at 1050, 5 USPQ2d at 1438; ACS Hosp. Sys., Inc. v. Montefiore Hosp., 732 F.2d 1572, 1577, 221 USPQ 929, 933 (Fed.Cir.1984). The ultimate determination of obviousness is a legal conclusion. When this legal conclusion is drawn by the jury the verdict is reviewed, as discussed in Part I.B, to determine whether substantial evidence supports the factual findings necessary to support the legal conclusion, with due consideration to the presumption of validity and the standard of proof.

Bard points out that its rotating sleeve mechanism for sequential energizing is a marked distinction from its earlier devices, even were the concept of sequential energizing deemed to be derivable from the manual operation of the first generation. M3 Systems does not cite any reference suggesting the structure employed in the third generation gun, or any suggestion of mechanical sequential energizing, or indeed the other features of the third generation. Those contributions came from the inventor, not the prior art. See Uniroyal, 837 F.2d at 1050, 5 USPQ2d at 1438. We have been directed to no teaching or suggestion of this combination in the descriptions of the first and second generation guns, viewed separately or together. Thus the verdicts of invalidity on the ground of obviousness are without essential factual support, and can not stand.

The jury found that M3 Systems did not infringe claims 15 and 16 of the '308 patent. Because the special verdicts discussed in Part III.A (that there is not support for these claims in the written description) require an incorrect claim construction, we have reviewed the verdicts of noninfringement on the correct construction, i.e., that claims 15 and 16 do not require a total absence of overlap in the sequential movement of the needles during energizing. Bard contends that on the correct claim construction the verdicts of noninfringement can not stand. Bard is entitled to a new trial if a jury reasonably could have reached verdicts of infringement upon correct claim construction and correct application of the law of infringement. However, if only one result is supportable in law and on undisputed facts, judgment as a matter of law is appropriate. See Strattec, 126 F.3d at 1419, 44 USPQ2d at 1036.

On appeal Bard argues only the issue of sequential energizing, asserting literal infringement under section 112 paragraph 6. M3 Systems does not dispute, and indeed emphasizes, that in its ProMag devices there is sequential energizing with a slight overlap in needle movement. However, M3's performance of the function of sequential energizing was not the only disputed issue with respect to infringement. M3 also points out that its device is a box-type biopsy gun and does not contain a "guide sleeve" as required by the claims, and that the M3 ProMag guns use linear tensioning whereas the '308 device performs counter-rotational tensioning, such that the structure used by M3 is not equivalent to that shown in the '308 specification, applying section 112 paragraph 6 to the energizing means of the '308 claims.

M3 Systems states that the '308 patent draws a distinction between box-type biopsy guns such as those made by M3 wherein the housing is merely a container for the device, and guns embodying a mechanism wherein the guide sleeve and a tensioning sleeve interact and serve as part of the cocking mechanism. M3 argued at trial that its housing is independent, whereas in the '308 specification the gun is housed in a two-part structure wherein the inner part is the guide sleeve and the outer part is the tensioning sleeve and rotates about the inner part. These sleeves bear cam surfaces and slots that interact with the flanges on the needle heads and thus serve as part of the cocking mechanism. M3 states that its gun has neither a guide sleeve nor a tensioning sleeve, and that its housing is merely the container for the device, and is unconnected with the cocking mechanism.

Although the claims in suit do not require a tensioning sleeve, see D.M.I., Inc. v. Deere & Co., 755 F.2d 1570, 1574, 225 USPQ 236, 239 (Fed.Cir.1985) (improper to import limitation from one claim into another claim lacking the limitation), the guide sleeve is described in the specification as "the inner sleeve or guide sleeve." The specification shows and the claims require that the guide sleeve perform a guiding function for the cocking mechanism. Bard does not assert that such a structure is found in the M3 guns. Nor does Bard raise on this appeal any issue of equivalency under the doctrine of equivalents.

At the trial the parties presented evidence on how the patented and accused devices worked, and the court instructed the jury as to the applicable law of infringement of means-plus-function claims. For the energizing means Bard was required to establish, by a preponderance of evidence, that M3 Systems' device embodies the structure described in the '308 specification or an equivalent thereof. 35 U.S.C. § 112 p 6; Valmont Indus., Inc. v. Reinke Mfg. Co., 983 F.2d 1039, 1041-42, 25 USPQ2d 1451, 1453-54 (Fed.Cir.1993); Texas Instruments, Inc. v. United States Int'l Trade Comm'n, 805 F.2d 1558, 1562-63, 231 USPQ 833, 834-35 (Fed.Cir.1986). Since the structure of the M3 energizing means is not the same as that described in the '308 specification, the issue was whether the structures are equivalent. See D.M.I., 755 F.2d at 1575, 225 USPQ at 239 ("[T]he sole question is whether the single means in the accused device which performs the function stated in the claim is the same as or an equivalent of the corresponding structure described in the patentee's specification as performing that function.") The determination of infringement under section 112 paragraph 6 is a factual question. In re Hayes Microcomputer Prods. Inc. Patent Litig., 982 F.2d 1527, 1541, 25 USPQ2d 1241, 1251 (Fed.Cir.1992); Intel Corp. v. United States Int'l Trade Comm'n, 946 F.2d 821, 841, 20 USPQ2d 1161, 1178 (Fed.Cir.1991); D.M.I., supra.

There was no dispute that the function of sequential energizing is performed in the M3 Systems' guns; the only question was whether the M3 guns employ the same or an equivalent of the structure described in the '308 specification. The accused equivalent structure need not have been known at the time the patented invention was made. See Texas Instruments, 805 F.2d at 1563-64, 231 USPQ at 834-35 ("It is not required that those skilled in the art knew, at the time the patent application was filed, of the asserted equivalent means of performing the claimed functions....")

It was explained at trial that to achieve sequential energizing in the '308 device the outer tensioning sleeve is rotated about the inner guide sleeve; cam surfaces on the interior of the tensioning sleeve push against wings built directly into the needle heads to compress the two springs in sequence, pressing them rearward into the locked position. In contrast, in the M3 Systems device a handle connected through the rear of the housing acts on sleds bearing the needles; M3's device relies on the lever-action of the handle, as opposed to a rotating sleeve, to pull, rather than push, the needle sleds sequentially back toward their respective latches. Bard had argued at trial, in connection with the issue of validity, that the claims "must be interpreted as means-plus-function terms in accordance with Valmont," and cited its "external integrated energizing mechanism that converts rotary motion to linear motion" to distinguish the '308 gun from its own earlier device. Claims must be interpreted the same way for determining infringement as was done to sustain their validity.

A reasonable jury could have found that the structure using rotational tensioning as the energizing means is substantially different from the energizing structure in the M3 Systems guns. Although Bard argues that it suffices for infringement if the energizing is achieved with the slight overlap shown in the '308 patent, that is, if the function of sequential energizing is performed, claims written in the form authorized by section 112 paragraph 6 are limited by the structure described and equivalents of that structure. Performance of the same function does not of itself establish infringement.

Bard directs us to the doctrine of claim differentiation, and argues that it is incorrect to interpret the "sequential energizing means" of claim 15 as limited to the structure in the specification, because other claims, not at issue, specifically state that structure. Bard argues that its claims in suit are broader in that they state only the function of sequential energizing, and that they therefore warrant broader scope than the claims that state a specific energizing structure. However, as we have discussed, claims that are written in the form authorized by section 112 paragraph 6 are by statute limited to the structure described in the specification and equivalents of that structure. As discussed in Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1538, 19 USPQ2d 1367, 1371 (Fed.Cir.1991) a "means-plus-function limitation is not made open-ended by the presence of another claim specifically claiming the disclosed structure which underlies the means clause or an equivalent of that structure."

Applying this law, and based on the absence of a guide sleeve or any counterpart structure, and the differences in the structures of the energizing mechanisms, we conclude that on the correct claim interpretation a reasonable jury could find that claims 15 and 16 are not infringed. The judgment of noninfringement of the '308 patent is affirmed.

M3 Systems charged that Bard had committed both fraud and inequitable conduct in prosecuting the '056 and '308 patents. The jury was not asked to decide the issue of inequitable conduct, which was reserved to the judge and withdrawn by M3 after the favorable verdicts on the question of fraud. The jury found that it had been established by clear and convincing evidence that each of the '056 and the '308 patents had been procured by fraud in the Patent and Trademark Office.

Fraud in the procurement of a patent requires proof of the elements of fraud as developed in the common law: (1) that a false representation of a material fact was made, (2) with the intent to deceive, (3) which induced the deceived party to act in justifiable reliance on the misrepresentation, and (4) which caused injury that would not otherwise have occurred. See Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1069-70, 46 USPQ2d 1097, 1105-06 (Fed.Cir.1998); Norton v. Curtiss, 57 C.C.P.A. 1384, 433 F.2d 779, 792-94 & n. 12, 167 USPQ 532, 543-45 & n. 12 (CCPA 1970) (citing W. Prosser, Law of Torts §§ 100-05 (3d ed.1964)).

The tort of fraud requires that there was a successful deception, and action taken by the person deceived that would not have otherwise been taken. Applied to patent prosecution, fraud requires (1) a false representation or deliberate omission of a fact material to patentability, (2) made with the intent to deceive the patent examiner, (3) on which the examiner justifiably relied in granting the patent, and (4) but for which misrepresentation or deliberate omission the patent would not have been granted. A finding of fraud can of itself render the patent unenforceable, and when accompanied by the elements of violation of the Sherman Act, as discussed in Part VI, can incur additional consequences.

To establish fraud for purposes of antitrust violation the defendant "must make a greater showing of scienter and materiality" than when seeking unenforceability based on conduct before the Patent Office. 6 Donald S. Chisum, Chisum on Patents § 19.03[e] (rel. 47 1993) (citations omitted). In Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 177, 86 S.Ct. 347, 15 L.Ed.2d 247, 147 USPQ 404, 407 (1965) the Court clarified that "knowing and willful" fraud must be shown, and is predicate to potential antitrust violation. As explained in Handgards, Inc. v. Ethicon, Inc., 601 F.2d 986, 996, 202 USPQ 342, 351 (9th Cir.1979), "[t]he road to the Patent Office is so tortuous and patent litigation is usually so complex, that 'knowing and willful fraud' as the term is used in Walker can mean no less than clear, convincing proof of intentional fraud involving affirmative dishonesty, 'a deliberately planned and carefully executed scheme to defraud * * * the Patent Office.' ... Patent fraud cases prior to Walker required a rigorous standard of deceit.... Walker requires no less." (Emphasis and elisions in original.) The requirements of common law fraud are in contrast with the broader sweep of "inequitable conduct," an equitable defense that may be satisfied when material information is withheld with the intent to deceive the examiner, whether or not the examiner is shown to have relied thereon. See Kingsdown Med. Consultants v. Hollister, Inc., 863 F.2d 867, 872, 9 USPQ2d 1384, 1389 (Fed.Cir.1988).

M3 Systems stated that Bard made myriad material misrepresentations in prosecuting the '056 and the '308 patents, including the following: the incorrect inventors were named; actual samples of the Tru-Cut needles and the first generation device were not provided to the examiner; the Baxter patent on the Tru-Cut needle and two Lindgren articles on the first generation device were not provided to the examiner; the material submitted to the FDA was not provided to the examiner; the examiner was not told of the co-pending design patents; and the examiner was not provided with all of the evidence on the on-sale issue. Bard responded that there is no substance to any of these assertions; that all material information was presented to the examiner; that there was no intent to deceive the examiner; that the examiner was not deceived; and that the evidence points to good faith in the prosecution of these patents. Good faith is an absolute defense to the charge of common law fraud. See Walker Process, 382 U.S. at 177, 86 S.Ct. 347, 147 USPQ at 407.

M3 Systems argues that any omission in the submissions to the PTO is "necessarily material, because the allowance of the application is the intended natural consequence of that submission." That is not a correct statement of the law. There is no presumption that information not filed by an applicant was material simply because patentability ensued. To establish culpability any omission must be of a fact material to patentability and it must be a deliberate misrepresentation, whether by omission or misstatement, that was intended to and did mislead the examiner into taking favorable action that would not otherwise have been taken. Intent to mislead or to deceive must be proved by clear and convincing evidence. See Walker Process, supra. Deceptive intent is not inferred simply because information was in existence that was not presented to the examiner; and indeed, it is notable that in the usual course of patent prosecution many choices are made, recognizing the complexity of inventions, the virtually unlimited sources of information, and the burdens of patent examination. See Northern Telecom, 908 F.2d at 939, 15 USPQ2d at 1327 (discussing the ease with which routine patent prosecution may be portrayed as tainted conduct).

Following are the actions that M3 Systems presented as probative of fraud in the prosecution of the '056 or the '308 patent:

This issue was discussed ante in connection with the validity of the '056 patent. There was no evidence of intent to deceive in correcting the inventorship to include Mr. kerfeldt with Dr. Lindgren as joint inventors. The question of Mr. Taylor's role as a possible inventor did not present substantial evidence of fraud. Indeed, since the inventorship issue was not grounds of invalidity, it can not satisfy the "but for" test of fraud.

2. Provision of Actual Models to the Examiner

M3 Systems argued that Bard should have provided the reissue examiner with actual models of the first generation gun and the Tru-Cut needles, in addition to the PCT application and publications describing the needles. The PCT application described the first generation gun, and descriptions of the Tru-Cut needles were before the examiner. Reviewing the prosecution history we do not discern substantial evidence of material withholding, for cumulative information is not material to patentability, and there was no evidence of deceptive intent or that the examiner was deceived into granting the reissue. This issue can not support the verdict of fraud.

3. Provision of On-Sale Information to the Examiner

Bard filed with the PTO descriptions of the transactions involving Radiplast and Pharmaseal before the critical date, accompanied by documents including the invoice for the 10 guns and 250 needles for the clinical trials, the bulk price quotation discussed ante in connection with the on-sale issue, and declarations concerning the hospital tests and the proposed distribution relationship between Radiplast and Pharmaseal. M3 Systems states that Bard should have also disclosed to the PTO Radiplast's sales activities for the first generation device, Radiplast's letters to doctors concerning the clinical trials, the fact that the bulk price quotation included a profit, and Radiplast's letter to Dr. Phelps.

Concerning Dr. Phelps, Bard answers that it submitted to the PTO all the relevant material it had obtained. The letter to Dr. Phelps was obtained after suit was filed, during discovery of Radiplast's files in Sweden. There was no evidence that Bard had obtained and withheld this information during the reissue prosecution. With respect to the bulk price quotation, M3 Systems states that Bard should have flagged this document and described its significance to the examiner, lest it be overlooked in the volume of paper. Bard responds that the documents provided to the examiner were a record of Radiplast's efforts to find a distributor and its transactions with Pharmaseal, and that the total number of documents was not so voluminous, or the contents so difficult to understand, as to support an inference of intentional concealment of any particular document that was filed. We agree that these documents, all in the prosecution history, are easily read.6

On reviewing these filings in the PTO we have been directed to no evidence of material withholding or the provision of false information, or of intent to deceive or actual deception. The additional subject matter that M3 states should have been included was not shown to be material or other than cumulative. These actions did not constitute substantial evidence of fraud.

4. Disclosure of the Information Filed with the FDA

None of the material provided us with respect to Radiplast's 510(k) pre-market notification filed with the Food & Drug Administration supports a finding of fraud in the patent prosecution. M3 Systems concentrates on the presence in this package of needle drawings made by Hart Enterprises, the designated manufacturer. As we have explained, the inventorship issues that have been raised do not provide substantial evidence of fraudulent procurement of these patents.

The PCT application had been submitted to the PTO during prosecution of the '154 patent and again during the '056 reissue proceedings. M3 Systems states that Bard withheld the PCT application from the examiner of the '308 patent and then mischaracterized it.

M3 Systems stated at trial and repeats on this appeal that Bard submitted the PCT application to the examiner of the '308 patent only after allowance of the '308 claims in suit, and then falsely represented that it was relevant solely to newly added claims 21-23 (as