January 2014
Knowledge of a Goal Does Not Render Its Achievement Obvious
| Judges: Newman, Clevenger, Taranto (author) |
| [Appealed from Board] |
In Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, Nos. 12-1485, -1486, -1487 (Fed. Cir. Dec. 30, 2013), the Federal Circuit reversed the Board’s decision that claims 10 and 12 of U.S. Patent No. 6,610,545 (“the ’545 patent”) were obvious; vacated and remanded the Board’s decision that the claims of U.S. Patent No. 6,833,252 (“the ’252 patent”) were obvious; and dismissed as moot the Board’s decision regarding U.S. Patent No. 7,309,605 (“the ’605 patent”).
Institut Pasteur and Universite Pierre et Marie Curie (collectively “Pasteur”) own the ’605, ’545, and ’252 patents, which claim methods and tools for inserting or deleting genes at targeted locations in the chromosomes of living cells (“gene targeting”) using group I intron encoded endonucleases (“GIIE endonucleases”). Precision BioSciences, Inc. (“Precision”) requested inter partes reexamination of each patent, and the examiner rejected a number of Pasteur’s claims as obvious during reexamination. The Board affirmed the examiner’s rejections, and Pasteur appealed. While the appeal was pending, the involved patents expired.
The Court dismissed as moot the appeal relating to the ’605 patent, finding that Pasteur substantively narrowed the scope of claim 14 during reexamination by amending the claim to recite that the targeted DNA was “chromosomal.” The Court rejected Pasteur’s argument that the scope was unchanged because the claim was already limited to chromosomal DNA. Specifically, Pasteur argued that claim 14 was limited to “chromosomal DNA” even before the amendment because it recited that the targeted DNA undergoes homologous recombination with a newly introduced plasmid whose sequence is “homologous to the sequence of [a] chromosome.” Slip op. at 13 (alteration in original) (citation omitted). The Court rejected this reasoning, finding that the newly introduced plasmid may be homologous to both chromosomal and nonchromosomal DNA, and, therefore, the original claim did not exclude homologous recombination in nonchromosomal DNA. Therefore, the Court found that the amendment limiting the claims to chromosomal DNA changed the scope of the claims. Because under 37 C.F.R. § 1.530(j) and (k), the PTO cannot issue an amended claim for an expired patent if the amendment substantively changes the claim’s scope, the Court dismissed Pasteur’s appeal relating to the ’605 patent as moot.
The Federal Circuit next considered the Board’s findings of obviousness with regard to claims 10 and 12 of the ’545 patent. The Court found that two of the cited references (Bell-Pedersen and Quirk) disclosed gene transfer into nonchromosomal DNA in prokaryotic cells, and agreed with the Board that the key issue was whether the relevant skilled artisan—after reading these two references—would have expected that a GIIE endonuclease would successfully promote targeted gene transfer into the chromosomal DNA of eukaryotic cells, and thus had good reason to pursue that possibility. The Court held that the Board made prejudicial errors by making factual determinations about the prior art that were not supported by substantial evidence, and by failing to give proper consideration to at least two categories of evidence: (1) teachings in the prior art that targeting a cell’s chromosomal DNA could be toxic to the cell; and (2) industry praise and licensing of Pasteur’s invention.
First, the Court found that the Board erred in finding that the Frey and Dujon references showed that a GIIE endonuclease cleaved yeast chromosomal DNA when expressed in yeast cells. “Because no other references identified by the Board show a GIIE endonuclease cleaving chromosomal DNA in a eukaryotic cell, its errors were highly material to whether the ’545 patent claims would have been obvious.” Id. at 17.
“[T]he expectation-of-success analysis must match the highly desired goal, not switch to a different goal that may be a less challenging but also less worth-while pursuit.” Slip op. at 18 (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)).
The Court then found that the Board compounded its erroneous findings by ignoring teachings that targeting a GIIE endonuclease to chromosomal DNA in a living cell could be highly toxic. The Court explained that the Board identified no reason at all that a skilled artisan would have pursued a method toxic to cells. The Federal Circuit found that instead, the Board relied on the interest stated by the Old reference that “[i]t would be a great advance if such alterations could be engineered into copies of a chosen gene in situ within the chromosomes of a living animal cell.” Id. at 18 (alteration in original) (citation omitted). The Court cautioned that “knowledge of the goal does not render its achievement obvious.” Id. (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008)). The Court stated that “without a sound explanation for doing otherwise, which is not present here, the
expectation-of-success analysis must match the highly desired goal, not switch to a different goal that may be a less challenging but also less worth-while pursuit.” Id. (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)).
Regarding objective indicia of nonobviousness, the Federal Circuit held that the Board erred by too finely parsing Pasteur’s evidence of industry licensing and by dismissing Pasteur’s evidence of praise based on a misreading of the prior art. With regard to licensing, the Court explained that the Board rejected the evidence of licensing because the declaration by the inventor and exclusive licensee “did not establish that the third parties specifically licensed the patent family to gain access to the subject matter claimed in the ’545 patent, rather than other technology described in the patent but not claimed or claimed in related patents.” Id. at 20 (citation omitted). The Court found that theoretical possibility does not undermine the strong probative value of the licensing of the ’545 patent, stating that “[t]he central success described in the patent is the one prior art hoped for and is captured in the claims at issue.” Id.
With regard to industry praise, the Court explained that while the Board acknowledged that Pasteur established a connection between the praise by the industry and the claimed homologous recombination step, the Board found that the step was possessed by the prior art and therefore not a proper basis to rebut the prima facie case of obviousness. The Federal Circuit, however, found that under a correct reading of the Dujon reference, the step was not shown. Thus, the Court held that industry praise, like others’ licensing of Pasteur’s invention, provided probative and cogent evidence that one of ordinary skill in the art would not have reasonably expected that a GIIE endonuclease could successfully modify chromosomal DNA in eukaryotic cells. The Federal Circuit thus reversed the Board’s rejection of claims 10 and 12 of the ’545 patent.
Turning to the ’252 patent, the Court noted that its disposition follows from its discussion of the ’545 patent. The ’252 patent claims recite a recombinant mammalian chromosome comprising a GIIE endonuclease recognition site, which the Federal Circuit explained was a first step to practicing the method recited by claims 10 and 12 of the ’545 patent. In vacating the Board’s conclusion and remanding to the Board for reconsideration, the Federal Circuit explained that the Board identified only a single reason that one of ordinary skill in the art would have attempted to make a recombinant chromosome containing a GIIE endonuclease recognition site: to apply the homologous recombination method disclosed by the Bell-Pedersen and Quirk references to chromosomal DNA in mammalian cells. The Court held that this reason was insufficient to support a determination of obviousness, for the reasons discussed in connection with the ’545 patent.
The Federal Circuit explained that the Board never considered whether other motivations would have made the chromosome claimed by the ’252 patent obvious. Specifically, the Board did not make a finding about whether a skilled artisan would have introduced a GIIE endonuclease recognition site into a mammalian chromosome even without reasonably expecting its successful use for the site-directed insertion of DNA. Although mentions were made at oral argument about other uses for such recombinant chromosomes, the Court cautioned that “obviousness is determined at the time the invention was made, so current uses for the recombinant chromosomes, without more, would not establish a sufficient motivation at the time of invention.” Id. at 24 (citation omitted). Finally, regarding objective evidence of nonobviousness, the Court held that the use of the ’252 patent claims as a necessary first step for a method that others in the industry licensed, praised, and copied, does not demonstrate that they did so because of that first step. The Court thus vacated the Board’s conclusion for the ’252 patent and remanded for further consideration.
