A claim must be considered as a whole for purposes of written description support, rather than as a collection of individually supported limitations. While the disclosure of a myriad of unclaimed or even inoperative embodiments is not necessarily invalidating, the disclosure must provide some indication that the inventor had invented at least one embodiment, by the time of filing, that falls within a narrower claimed combination as a whole. A mere undifferentiated roadmap that provides nothing more than an “invitation to experiment” fails to provide guidance toward a later-claimed solution. The court specifically noted that “[i]n this case, to actually possess the variant enzymes claimed in the … patent would have required [the applicant] to confirm its predictions by actually making and testing individual variants or at least identifying subclasses of variants that could be expected to possess the claimed properties, which it did not do before filing the 2000 application.”
Background / Facts: The patent here relates to recombinant enzyme technology for enhanced stability alpha-amylases in commercial applications such as detergent formulations, sugar refining, and ethanol production, among others. The patent derives from a continuation application reaching back to a provisional from the year 2000 (the “2000 application”). The continuation application was filed in response to accused infringer DuPont introducing their own enhanced stability alpha-amylase, with all claims requiring at least three specific features relating to a parent sequence, a substitution position, and increased thermostability. Each of these limitations can be found at points within the underlying 2000 application, but, outside of the continuation claims, they were never presented together in any particular embodiment and the application did not highlight the particular parent or substitution position claimed among the other disclosed options. Given the number of parent enzymes (7), the number of target positions in each of those parent enzymes (33), and the number of possible mutations at each of those target positions (at least 40), the disclosure in the 2000 application spans a potentially wide range of alpha-amylase variants.
Issue(s): Whether the supporting disclosure of the 2000 application providing only generalized guidance listing several variables that might, in some combination, lead to a useful result is sufficient to show that the inventors had possession under the written description requirement of § 112, ¶ 1, of the more narrowly recited specific alpha-amylase variants in the claims that result from mutating a particular parent enzyme at a single amino acid position to yield distinctive functional properties.
Holding(s): No. “While the 2000 application provides formal textual support for each individual limitation recited in the claims of the … patent, it nowhere describes the actual functioning, thermostable alpha-amylase variants that those limitations together define. Taking each claim—as we must—as an integrated whole rather than as a collection of independent limitations, one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any ‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.” It is only “working backward from a knowledge of [the claims], that is by hindsight, [that the patentee] seeks to derive written description support from an amalgam of disclosures plucked selectively from the 2000 application.”