Chinta & Fratangelo LLP

Contact the author: Andrew Berks

Inst. Pasteur v. Focarino, No. 2012-1485 (Fed. Cir. 12/30/2013)

Three patents were at issue, US6610545, US6833252, and US7309605, all based on an application originally filed 5/6/1992 and expired on 5/6/2012. The patents disclose group I intron encoded (GIIE) endonucleases. GIIE endonucleases are valuable research tools that are highly specific in selecting DNA cleavage sites. The claims were directed to methods of cleaving DNA, site directed genetic recombination, and recombinant mammalian chromosomes. The PTAB holding that the claims at issue were obvious was reversed in this appeal. (Before Newman, Clevenger, and Taranto, opinion by Taranto). This case also addresses jurisdictional issues of amendment of expired patent claims.

In 2009, Precision Biosciences, Inc., a co-appellee in this matter, filed an inter partes reexamination request for the three patents at issue. The request was granted, and Pasteur sought to amend the claims during the reexamination to be limited to chromosomal DNA in viable eukaryotic cells. However, the examiner rejected most claims as anticipated or obvious. The examiner was upheld on appeal to the Patent Trial and Appeal Board. The Board cited references from Quirk and Bell-Pedersen disclosing using a GIIE endonuclease to transfer DNA from a plasmid to non-chromosomal DNA in bacterial (i.e., prokaryotic) cells, and concluded based on other references that it would be obvious to substitute the eukaryotic DNA into the method of Quirk and Bell-Pedersen. The Board found a reasonable expectation of success in the Frey and Dujon references. For two of the patents, the Board considered Pasteur’s evidence that the claimed inventions were praised, copied, and licensed by the industry, but concluded that the evidence did not outweigh the “strong case of obviousness.”

On appeal to the Federal Circuit, the PTO sought to have all claims except claims 10 and 12 of the ‘545 patent dismissed as moot because the patents were all expired. Pasteur opposed dismissal of claim 14 of the ‘605 patent. These three claims were at issue in the appeal.

With respect to claim 14 of the ‘605 patent, Pasteur sought to reverse the Board holding that this claim was obvious. During the reexamination, Pasteur sought to substantively narrow claim 14, by limiting it chromosomal DNA. But under the pre-AIA statute, when a claim is substantively amended in an inter partes reexamination, the analysis of intervening rights after issuance treats an amendment as raising an irrebuttable presumption that the original claim was materially flawed, so there can be no liability for infringement before the amended claim issues. Since the ‘605 patent is expired, the claim amendments cannot be entered, because Pasteur cannot be granted rights beyond the term of the patent. The panel therefore dismissed Pasteur’s appeal with respect to the ‘605 patent.

With respect to claims 10 and 12 of the ‘545 patent, Pasteur appealed the Board holding that the patents were obvious. The Federal Circuit panel reversed the Board’s holding that the claims were obvious, finding that (1) teachings in the prior art that targeting a cell’s chromosomal DNA could be toxic to the cell (teaching away) and (2) industry praise and licensing of Pasteur’s invention (secondary factors), were not properly considered by the Board. The opinion states that these errors were prejudicial.

Regarding the teachings of the prior art, the panel asserts that the Board “misread” (slip op. at 17) the Frey and Dujon references, relied upon to support the finding that the GIIE digestion of prokaryotic DNA could be extended to eukaryotic yeast cells. The Frey reference disclosed GIIE digestion of DNA extracted from yeast cells, but the claims required digestion of DNA within the cells. The Dujon reference did not clearly disclose digestion of cellular DNA. The Board therefore failed to establish a prima facie case of obviousness.

Also, the Board ignored teachings that targeting a GIIE endonuclease to chromosomal DNA in a living cell would be highly toxic. The panel did not use the words “teaching away” here, but rather says that such a teaching counts significantly against finding a motivation to take the claimed steps with a reasonable expectation of success. According to the panel, this was not a harmless error.

Also, the objective indicia of non-obviousness that the industry licensed, praised, and copied Pasteur’s inventions was erroneously disregarded by the Board. Accordingly, the panel reversed the Board’s rejection of claims 10 and 12 of the ‘545 patent.

The panel also remanded on the issue of the ‘252 patent claims. The ‘252 patent claims are effectively the first step to practicing claim 12 of the ‘545 patent. The Board rejected the ‘252 claims on the same basis that it rejected the ‘545 claims, but the opinion notes that the Board failed to consider whether other motivations could have made the ‘252 claims obvious, and also failed to consider objective-indicia evidence for the ‘252 patent.

Comment. This case is an inventor-friendly case holding that findings of obviousness in crowded arts (including genetic engineering) must be carefully weighed. The sloppy analysis all to often applied by the USPTO in finding patents obvious was reversed here.