Marilyn Hall Patel, United States District Judge.
Plaintiff Du Pont brings this action seeking a declaration of invalidity of defendant Cetus Corporation's U.S. patents 4,683,202 ("'202 patent") and 4,683,195 ("'195 patent"), which encompass the process of polymerase chain reaction ("PCR") using an exponential process of replication.
In its motion for summary judgment, plaintiff argued that a National Science Foundation grant proposal submitted by Dr. Gobind Khorana ("NSF Grant Proposal") anticipates the subject matter of the '202 patent and thus invalidates the patent under 35 U.S.C. 102(b).
In its opposition to plaintiff's motion, defendant argued that a material issue of fact exists as to whether the Khorana Grant Proposal is prior art. Specifically, defendant claimed that the Grant Proposal was not adequately stored and indexed, and hence was not sufficiently accessible to the interested segment of the public to constitute a "printed publication" under section 102(b). In addition, defendant noted that the Grant Proposal had a vague title ("Chemical and Biological Studies of Nucleic Acids").
The court found that, for the purposes of summary judgment, sufficient evidence had been presented that the Grant Proposal was accessible to the relevant public prior to one year before the date of the patent application to treat it as prior art. However, the court concluded that even assuming arguendo that the Grant Proposal met the standard for prior art, it did not describe the process of PCR with sufficient precision and detail to constitute anticipation of defendant's patent under section 102(b) as a matter of law.
During review of the issue at pre-trial conference on November 20, 1990, defendant informed the court that it intended to challenge at trial the Grant Proposal's status as prior art, and that it also intended to introduce a later grant application submitted by Dr. Khorana to the National Institutes of Health ("NIH Grant Application") as prior art "pointing away" from anticipation. The court indicated its desire to avoid lengthy digression on this issue during trial, and stated that it would review the submissions of the parties to determine whether the issue could be decided by the court as a matter of law.
Having undertaken this review of the parties' arguments and the governing case law, the court finds that there is ample, undisputed evidence of the accessibility of the NSF Grant Proposal to the relevantly skilled and interested public, and that the law does not require the strong showing of "highly likely discovery of the prior art" suggested by defendant during the pre-trial conference. The court concludes that no jury could reasonably find that the NSF Grant Proposal was not prior art within the meaning of section 102(b). In addition, on the basis of the same arguments and considerations, it concludes that no jury could reasonably find that the NIH Grant Application was not prior art within the meaning of section 102(b). Therefore, the only issue remaining for trial is whether this prior art anticipated the patents under section 102, or otherwise rendered them obvious under section 103.
The statute governing anticipation of patents provides that
[a] person shall be entitled to a patent unless --
. . .
(b) the invention was patented or described in a printed publication . . . more than one year prior to the date of the application for patent in the United States, . . . .
A printed publication is a publication that is "sufficiently accessible" to members of the public who are interested in the art and exercise "reasonable diligence." RCA Corp. v. Data Gen. Corp., 701 F. Supp. 456, 468 (D. Del. 1988)(citing In re Hall, 781 F.2d 897, 900 (Fed. Cir. 1986)), judgment aff'd, 887 F.2d 1056 (Fed. Cir. 1989). The relevant time period in this case is prior to March 28, 1984, one year before the filing of the '202 application.
Whether a document is a printed publication within the meaning of section 102 is a legal determination, although it may involve underlying questions of fact. Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 936 (Fed. Cir.)(citing Hall, 781 F.2d at 899 (Fed. Cir. 1986)), cert. denied, U.S. , 111 S. Ct. 296 (1990).
Publication does not require dissemination in books or journals. Rather, given the advanced technology in information storage and retrieval, the courts regard "public accessibility" as the touchstone in determining whether a reference constitutes a printed publication under 35 U.S.C. 102(b). Hall, 781 F.2d at 898-99. In Hall, for example, the court found that a doctoral thesis that had been indexed, catalogued and shelved in the Freiburg University library was sufficiently available to the relevant interested public to constitute prior art.
Defendant cites several cases in which courts have found various scholarly publications not to be prior art, but these cases are clearly distinguishable. In Application of Bayer, 568 F.2d 1357 (C.C.P.A. 1978), the court held that a graduate thesis held in a university library was not prior art where, as of the critical date for availability, it had not been catalogued or shelved and was available only to the student's thesis committee. Id. at 1359.
The court in In re Cronyn, 890 F.2d 1198 (Fed. Cir. 1989), also cited by defendant, held that undergraduate senior theses filed in the college's main and departmental libraries were not printed publications. Id. at 1161. It found that the theses had not been "either cataloged [sic] or indexed in a meaningful way," since they were referenced only by index cards filed alphabetically by author and held in a shoebox in the chemistry department. The court distinguished Hall, in which doctoral dissertations had been indexed, catalogued, and shelved, and noted that such systematic storage and indexing is the "critical difference" in determining whether a document is a "printed publication." Id.
In the case at bar, by contrast with both Bayer and Cronyn, deposition testimony of Brian Mannion, Section Head of Grants and Awards for NSF, indicates that Dr. Khoranas NSF Grant Proposal was filed, indexed by title, author, institution and grant number in the NSF's published indices of grants and awards beginning in 1973. Mannion Decl. (Ex. E of Newland Decl.), Ex. 2. In addition, the Proposal was available upon request from NSF under the Freedom of Information Act, 45 C.F.R. 612 et seq., well before the date of application of the PCR patents. Mannion Decl. at paras. 2-5.
Defendant suggests that the relevant test for accessibility is whether one skilled in the relevant art is likely to have encountered or tracked down the prior art, and argues that this inquiry presents an issue of fact to be resolved at trial. However, none of the cases submitted by defendant support this proposition. Under all of the existing case law, the appropriate inquiry in this case is not whether a DNA researcher would have come across the Khorana Grant Proposal or references to it in the course of her work, but rather whether the Proposal was "sufficiently accessible" to a researcher who exercised "reasonable diligence." Thus, the emphasis is on systematic indexing and availability upon request.
However, even under the more strenuous standard proposed by defendant, the Grant Proposal would qualify as prior art. Dr. Khorana was preeminent researcher and pioneer in the field of DNA technology at the time of the grant and thereafter; it was widely known in the scientific community that groundbreaking work was being done in his laboratory. Thus, anyone interested in the field would have been alert to the publications under Khorana's name, and defendant does not dispute this. Moreover, the Grant Proposal itself was cited by grant number in the 1974 article published by Panet and Khorana in the Journal of Biological Chemistry. Newland Decl., Ex. G. Any researcher interested in DNA replication is likely to have come across the article and would have been alerted to the relevance of the Khorana Grant Proposal from that citation.
The same reasoning applies to Dr. Khorana's 1975 grant application to the National Institutes of Health, through what was then the Department of Health, Education, and Welfare. This application was titled "Synthetic and Biological Studies of Nucleic Acids," and its predecessor grant, like the NSF Grant Proposal, was referenced by grant number on the first page of the Panet and Khorana article in the Journal of Biological Chemistry. Newland Decl., Ex. G. Access to the NIH Grant Application prior to March 28, 1984 was available under the Freedom of Information Act pursuant to 45 C.F.R. 5.72(b), which provides that records pertaining to Department of Health and Human Services grant applications are available to the public under the Act. See 45 C.F.R. 5.1 et seq. (1983).
For the above reasons, the court concludes that there are no underlying factual disputes and that, even assuming all facts as alleged by defendant, no reasonable jury could find that the Khorana NSF Grant Proposal and the Khorana NIH Grant Application were not accessible to the relevant public prior to March 28, 1984. It therefore rules as a matter of law that the two documents are prior art within the meaning of 35 U.S.C. 102(b).