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.

Post-filing art can be used to show that there is no reasonable expectation of success (BPAI)

Ex parte ATUL VARADHACHARY

Appeal 2008-3921

Application 10/732,429

Technology Center 1600

Decided: March 5, 2009

The claims at issue were

1. A method of treating tissue or organ transplant rejection in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to attenuate the tissue or organ transplant rejection.

34. A method of modulating the immune response against an organ or tissue transplant in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to modulate the response against the organ or tissue transplant.

Claim 1 was rejected as being inherently anticipated by a single reference; claims 1 and 34 were rejected as allegedly obvious. A prior art reference taught the administration of lactoferrin in organ transplant patients and immunocompromised patients. However, the reference only taught that it could be used to prevent infections not to attenuate rejection or modulate the response against the organ transplant. The case nicely summarizes inherent anticipation

"To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Thus, "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent." Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). "Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted). Therefore, the Examiner cannot establish inherency merely by demonstrating that the asserted limitation is probable or possible. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). However, "'[i]n general, a limitation or the entire invention is inherent and in the public domain if it is the 'natural result flowing from' the explicit disclosure of the prior art.'" Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (quoting Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). Therefore, "when considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure." Perricone, 432 F.3d at 1378.

The Examiner appeared to be arguing that since the compound was used in organ transplant cases it was necessarily and always being used to prevent rejection. The Board noted that some transplant patients will not have rejection and only infection and therefore the result will not always necessarily result from the prior art. "No evidence has been put forward by the Examiner that all, or even substantially all, transplant patients with infection are also experiencing rejection" Therefore, no anticipation.

With regards to obviousness the Examiner found a reference that discussed the oral administration of lactoferrin. However, the applicant submitted a post-filing reference that stated "[i]t has been reported in the literature that oral lactoferrin is not absorbed systemically through the mature gut to any significant degree." The Board when stating the law regarding obviousness stated, "An obviousness analysis requires that the prior art both suggest the claimed subject matter and reveal a reasonable expectation of success to one reasonably skilled in the art. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991)." Here, the BPAI found no reasonable expectation of success because of the post-filing reference. The Board concluded: "Thus, while [the primary reference] teaches that oral administration may be contemplated, the prior art at the time Appellants' claimed invention was made establishes that a person of ordinary skill in the art would have no expectation of successfully using orally administered lactoferrin in [the primary reference's] method." Therefore, "A person of ordinary skill in the art would not have a reasonable expectation of successfully practicing the claimed invention in view of the combination of" the cited references.

Case can be found here

Just because the group of obvious variants may be large does not make the use of any [one] any less obvious.

Ex parte JACQUES DEGELAEN et al. (BPAI)

Appeal 2008-5883 

Application 10/702,507 

Technology Center 1600 

Decided: February 25, 2009 

The claim at issue was an assay kit for detecting one or more antibiotics containing a β-lactam ring in a liquid dairy product.  The prior taught a similar assay but with a different receptor for recognizing the antibiotic.  The Examiner found the claim to be obvious.  The Board affirmed.  The applicant argued that there were a large number of bacterial receptors to choose from and no guidance to pick the one they chose and there was no expectation of success.  The Board disagreed and sided with the Examiner.  The Board stated:

"We recognize that there are a large number of bacteria from which beta-lactam receptors may be obtained, but just because the group of obvious variants may be large does not make the use of any specific-binding protein for a beta-lactam antibiotic any less obvious."

With regards to the expectation of success the Board stated that the applicant had not provided any scientific or other evidence to show that there would not have been a reasonable expectation of success. The Board once again reiterated that arguments of counsel are not sufficient.  

Case can be found here