Distribution of Manuscript With No Legal Obligation to Keep Confidential is Not a Printed Publication ""[w]here professional and behavioral norms entitle a party to a reasonable expectation" that information will not be copied or further distributed"

CORDIS CORPORATION,
v.
BOSTON SCIENTIFIC CORPORATION
and SCIMED LIFE SYSTEMS, INC., (FEDERAL CIRCUIT)

In the ongoing stent battle, Cordis and Boston Scientific appealed another case to the Federal Circuit. The issue most interesting is where the court further explained what constitutes a printed publication under 35 U.S.C. § 102(b). The facts are as follows:

• In 1980 the inventor of the ’762 patent, Dr. Palmaz, prepared a ten-page paper describing his work on stents. This paper is the “1980 monograph.” At that time he was a resident at a hospital in California. His name was not on the paper.
• He gave copies of the paper to approximately six of his teachers at an oral presentation of his work to these physicians and several other colleagues.
• Pursuant to agreements, Palmaz later gave copies of the monograph to two companies (Vascor, Inc., and Shiley, Inc.) while attempting to commercialize his stent technology.
• Neither agreement required confidentiality, and the Shiley agreement specifically stated that Shiley “shall not be committed to keep secret any idea or material submitted.”
• In 1983 Dr. Palmaz revised the paper; the revised paper became the “1983 monograph.”
  In 1983 he also gave a copy of both monographs to Werner Schultz, a technician from whom Dr. Palmaz was seeking fabrication assistance.
• When Dr. Palmaz joined the faculty in 1983 at the University of Texas, San Antonio, he gave a copy of the 1983 monograph to a doctor there (who then gave it to the technician setting up Dr. Palmaz’s laboratory) and to the university as part of a research proposal. Dr. Palmaz applied for the patent that became the ’762 patent in 1985.

The court explained the different scenarios that have been evaluated previously:

A document is publicly accessible if it “has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation.” In re Wyer, 655 F.2d 221, 226 (CCPA 1981) quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743 (S.D.N.Y.1966)). In general, “[a]ccessibility goes to the issue of whether interested members of the relevant public could obtain the information if they wanted to.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988). Many of our cases in this area have concerned publications available in libraries, and the question has been whether the publication has been sufficiently indexed to be publicly accessible. See, e.g., In re Cronyn, 890 , 655 F.2d at 226. Other cases have involved widespread distribution so that the public could easily obtain copies of the publication. , 545 F.3d 1340, 1350-51 (Fed. Cir. 2008). F.2d 1158, 1161 (Fed. Cir. 1989); In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986); In re WyerSee, e.g., Kyocera Wireless Corp. v. Int’l Trade Comm’n

The Issue here was framed this way:

Here we have a somewhat different question: whether the distribution to a limited number of entities without a legal obligation of confidentiality renders the monographs printed publications under § 102(b).

We have held that where a distribution is made to a limited number of entities, a binding agreement of confidentiality may defeat a finding of public accessibility. But we have also held that such a binding legal obligation is not essential. Klopfenstein, 380 F.3d at 1351. We have noted that “[w]here professional and behavioral norms entitle a party to a reasonable expectation” that information will not be copied or further distributed, “we are more reluctant to find something a ‘printed
publication.’” Id. at 1350-51.

The court found that the norms here were biased towards confidentiality:

The record here contains clear evidence that such academic norms gave rise to an expectation that disclosures will remain confidential…Therefore, the distribution to the academics did not render the monographs as printed publications under 35 U.S.C. § 102(b).

Boston Scientific urged that, "even if the academic and hospital distributions did not create public accessibility, the distribution of monographs to two commercial entities did so. "

The court noted:

"There is no claim here that the two commercial entities provided any express agreement to keep the document confidential; indeed, one entity’s disclosure agreement did not discuss the entity’s confidentiality obligations, and the other entity’s disclosure agreement specifically disclaimed such obligations (most likely to avoid a lawsuit resulting from inadvertent disclosure)."

Boston Scientific argue[d] that under the decision of our predecessor court, the Court of Claims, in Garrett Corp. v. United States, “[w]hile distribution [of a government report] to government agencies and personnel alone may not constitute publication, distribution to commercial companies without restriction on use clearly does.” 422 F.2d 874, 878 (Ct. Cl. 1970) (citation omitted).

However, [according to the court] "the evidence here was sufficient to support a conclusion that there was an expectation of confidentiality between Dr. Palmaz and each of the two commercial entities."

While the Shiley legal agreement executed before development discussions disclaimed a confidentiality requirement, Dr. Palmaz testified that he requested confidentiality during subsequent discussions and was “surprise[d]” when he was shown the language of the Shiley agreement. J.A. at 8517; id. at 19,354. There is no suggestion that the request for confidentiality was not, in fact, honored. Dr. Palmaz confirmed that the entities kept their copies of the monograph confidential, whether or not they were legally obligated to do so. J.A. at 8502. The district court noted that “there is no evidence that [the commercial entities] would have distributed, or in fact did distribute, the 1980 Monograph outside of the company.” Cordis Corp. v. Boston Scientific Corp., Civ. No. 03-027-SLR, 2005 WL 1331172, at *4 (D. Del. June 3, 2005). There was no showing that similar documents in the past became available to the public as a result of disclosure by these or similar commercial entities, that these or similar commercial entities typically would make the existence of such documents known and would honor requests for public access, or that these or similar commercial entities had an incentive to make the document available, etc. The mere fact that there was no legal obligation of confidentiality—all that was shown here—is not in and of itself sufficient to show that Dr. Palmaz’s expectation of confidentiality was not reasonable."

Other issues in the case involved claim construction, obviousness, or anticipation but were generally ordinary.

The full opinion can be found here.

"Public use bar applies to obvious variants of the demonstrated public use"

In CLOCK SPRING v WRAPMASTER (Fed. Cir., March 25, 2009) the federal circuit invalidated a a claim due to a public use under 35 U.S.C. § 102(b). The claim at issue was:

A method for repairing a pipe
adapted to carry an internal load directed radially outward therefrom, said
pipe having a defective region defined by at least one cavity extending from
an outer surface of said pipe toward the center of said pipe but not extending
completely through the wall of said pipe, said method comprising the steps of:

providing a filler
material having a workable uncured
state and a rigid cured state,

filling said cavity to at
least said outer surface of said pipe with said filler material in said workable
state,

providing at least one band
having a plurality of elastic convolutions of high tensile strength material,

while said filler material is
in said workable state, wrapping said
plurality of convolutions of said high tensile strength material about said pipe
to form a coil overlying stud filler material[,]

tightening said coil about said
pipe so that said filler material completely fills that portion of said cavity
underlying said coil[,]

securing at least one of said convolutions to
an adjacent one of said convolutions, and

permitting said filler material to cure to said rigid
state, whereby a load carried by said pipe is
transferred substantially instantaneously from said pipe to said coil.

“[A] public use includes any public use of the claimed invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor.” Adenta, 501 F.3d at 1371 . "In order for a use to be public within the meaning of § 102(b), there must be a public use with all of the claim limitations. "

There was no dispute that the use was public and there was no control over the people demonstrating the use or observing it. "(“An invention is in public use if it is shown to or used by an individual other than the inventor under no limitation, restriction, or obligation of confidentiality.”). They found that the filling cavaties would have been obvious in view of the demonstration. Therefore, even though the exact limitation may not have been in public use it still qualified because, as the Federal Circuit stated: "We have held that the public use bar applies to obvious variants of the demonstrated public use. Netscape Commc’ns Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed. Cir. 2002)."

They further found that all other elements were part of the demonstration and therefore it was barred under 102(b). Patentee also tried to argue that it was an experimental use. The Federal Circuit found that there was no control, which although not dispositive indicates that it may not be experimental. "A use may be experimental only if it is designed to (1) test claimed features of the invention or (2) to determine whether an invention will work for its intended purpose—itself a requirement of patentability. " The patentee argued that the demonstration was done to determine the durability of the method and end product but there was no evidence of record indicating that this was indeed true. "Clock Spring’s problem, however, is that no report in the record states, or in any way suggests, that the 1989 demonstration was designed to test durability for the purposes of the patent application to the PTO. " Rather there was evidence that durability was for the end user rather than for patentability.

Interestingly, the district court had decided that there was an issue of material fact regarding the public use and found the claims invalid for being obvious. The CAFC reversed the public use decision and did not decide obviousness.

The case can be found here.