Opinion ID: 1034626
Heading Depth: 2
Heading Rank: 2

Heading: issues

Text: The written description requirement is set forth in the first paragraph of 35 U.S.C. § 112. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1343–45 (Fed. Cir. 2010) (en banc). In pertinent part, § 112 provides that: The specification shall contain a written description of the invention, and of the manner and pro- cess of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and DuPont’s parallel motion for judgment as a matter of law on the issue of enablement. NOVOZYMES A/S v. DUPONT NUTRITION BIOSCIENCES 15 use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 35 U.S.C. § 112, ¶ 1 (2006). To satisfy the written description requirement, “the applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’ and demonstrate that by disclosure in the specification of the patent.” Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991)). Accordingly, claims added during prosecution must find support sufficient to satisfy § 112 in the written description of the original priority application. See, e.g., Anascape, Ltd. v. Nintendo of Am., Inc., 601 F.3d 1333, 1335 (Fed. Cir. 2010). Assessing “possession as shown in the disclosure” requires “an objective inquiry into the four corners of the specification.” Ariad, 598 F.3d at 1351. Ultimately, “the specification must describe an invention understandable to [a] skilled artisan and show that the inventor actually invented the invention claimed.” Id. A “mere wish or plan” for obtaining the claimed invention does not satisfy the written description requirement. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997). The written description inquiry presents an issue of fact. Ariad, 598 F.3d at 1351.
To begin, Novozymes argues that the level of skill in the art of alpha-amylase biotechnology is very high and that, at the time that the 2000 application was filed, a person of ordinary skill in that art would have recognized the field as well developed and predictable. Specifically, Novozymes contends that alpha-amylases have been studied since 1833 and that, by the time it filed the 2000 application, the amino acid sequences and three- 16 NOVOZYMES A/S v. DUPONT NUTRITION BIOSCIENCES dimensional structures of many alpha-amylases had been solved, methods for introducing mutations into alphaamylase proteins and measuring the resulting variants’ enzymatic activity were well known, and the use of alphaamylase structure-function relationships in designing variants was commonplace and effective. Novozymes further argues that the key to deriving functional alphaamylase variants lies in finding the right position to mutate rather than the specific mutation(s) made at that position. In that context, Novozymes asserts that sufficient evidence supported the jury’s validity determination, emphasizing that the 2000 application expressly discloses each limitation of the asserted claims, namely (1) a parent BSG alpha-amylase; (2) a substitution at the S239 position; and (3) increased thermostability at 90°C, pH 4.5, and 5 ppm calcium. In Novozymes’s view, a person of ordinary skill in the art thus would have understood the 2000 application as clearly describing the claimed invention. Moreover, Novozymes argues that the district court revisited factual issues without applying the deferential standard demanded by Rule 50(b). In particular, Novozymes complains that the district court discounted its experts’ testimony indicating that a person of ordinary skill in the art would have had no difficulty deriving the claimed invention from the disclosure of the 2000 application. In addition, Novozymes distinguishes Boston Scientific and like cases on the grounds that those cases concerned complex, unpredictable technologies and involved written descriptions that lacked express disclosure of the claimed subject matter. Relying on Snitzer v. Etzel, 465 F.2d 899 (CCPA 1972), Novozymes argues that the 2000 application’s written description is not deficient simply because it discloses unclaimed inventions and inoperative species. Novozymes also points to Union Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989 (Fed. Cir. NOVOZYMES A/S v. DUPONT NUTRITION BIOSCIENCES 17 2000), as illustrating that the level of ordinary skill and predictability in an art inform the written description inquiry. According to Novozymes, Union Oil demonstrates that a disclosure is not lacking merely because it relies on the understanding of an ordinarily skilled reader. For its part, DuPont defends the district court’s judgment, arguing that the written description requirement precludes premature claims to a research plan and requires the disclosure of an actual invention. According to DuPont, Novozymes disclosed in its 2000 application no more than a theory or a laundry list of potential solutions, while DuPont performed the hard, inventive work of actually deriving a useful variant of BSG alpha-amylase. Citing In re Ruschig, 379 F.2d 990 (CCPA 1967), DuPont argues that where a patentee adds claims during prosecution that, as here, were not included in the original priority application, courts require a detailed description and identification of the later-claimed invention in the original disclosure, particularly where the specification discloses numerous possibilities with scant guidance on which to select. In this case, DuPont points out that the 2000 application fails to disclose a single alphaamylase variant substituted at position 239 that actually exhibits increased thermostability, noting that the only disclosed substitution at that position (S239W) disclosed in the 2000 application does not work as required by the ’723 patent’s claims. DuPont also asserts that the 2000 application’s undifferentiated disclosure was no more than an “invitation to experiment” that failed to provide guidance toward the later-claimed solution. Additionally, DuPont discounts Union Oil as conflating the written description requirement with “enablement reasoning,” an approach that it claims is no longer viable in view of Ariad. DuPont also distinguishes Union Oil on the ground that the disclosure in that case taught exactly 18 NOVOZYMES A/S v. DUPONT NUTRITION BIOSCIENCES how to make compositions with the claimed properties, while the disclosure of the 2000 application offers no insight as to how any given mutation at any of the disclosed amino acid positions would affect the functional properties of a resulting variant. Finally, DuPont accuses Novozymes and its experts of relying on hindsight to work backward from the claims of the ’723 patent, filed in 2009, to show that, given knowledge of the claimed invention, each limitation could be retroactively derived from the disclosure of the 2000 application.