Skating the Thin Ice of the Written Description Requirement

In recent years, cases such as Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed. Cir. 2002) ('Enzo') and University of Rochester v. G.D. Searle and Co., Inc., 375 F.3d 1303 (Fed. Cir. 2004) ('Rochester') have fueled an ongoing debate over whether the first paragraph of 35 U.S.C. '112 includes a written description requirement, separate and distinct from enablement and best mode. According to Judge Randall Ray Rader, Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) ('Eli Lilly') brought the written description requirement squarely to light. Rochester, 375 F.3d at 1307 (Circuit Judge Rader dissenting). This 'new' requirement creates 'enormous confusion,' not only for the courts, but also for patent drafters. Id. Because the requirement is in flux, patent practitioners should avoid overlooking the requirement or taking it too lightly.

In Rochester, a sharply divided Federal Circuit declined to rehear the district court's decision that invalidated a patent previously held by the University for failing to meet the separate written description requirement. Judge Alan David Lourie, in his concurring opinion, wrote that 'there is and always has been a separate written description requirement in the patent law.' Id. at 1305. Both Judges Richard Linn and Rader disagreed. First, '[r]eading into paragraph 1 of section 112 an independent written description requirement, divorced from enablement, sets up an inevitable clash between the claims and the written description as the focus of the scope of coverage. This is ill-advised.' Id. at 1307. Second, the Federal Circuit's issuance, withdrawal and re-issuance of the decision in the Enzo case indicated that a controversy existed over whether the written description requirement, as a separate and distinct requirement, is indeed valid. In Enzo, the Federal Circuit initially held that 'a deposit is not a substitute for a written description of the claimed invention.' Id. at 1308 (citation omitted). In so holding, the Federal Circuit applied the recently adopted requirement from Eli Lilly that a biotechnological invention must include a nucleotide-by-nucleotide recitation of its structure. Accordingly, the Enzo court invalidated the claims to a polypeptide detector, even though the patent described the polypeptides and three samples of the specifically claimed material were deposited at the American Type Culture Collection. Rochester, 375 F.3d at 1308. The Federal Circuit hastened to withdraw the initial Enzo decision following a firestorm of controversy and reversed the result. Id.

Despite the majority's decision not to rehear the Rochester case en banc, it still called for the confusion surrounding the written description requirement to be settled. Judge Timothy B. Dyk, in a concurring opinion, stated, 'In my view we have yet to articulate satisfactory standards that can be applied to all technologies.' Id. at 1308. Judge Pauline Newman, in her dissent, stated, 'This question has percolated enough; it is ripe for en banc resolution.' Id. at 1307. Whether the Federal Circuit will continue to invalidate patents for failing to comply with the separate written description requirement, revert to a more traditional role 'to prevent applicants from adding new inventions to an older disclosure,' or even limit the scope of the requirement to fields such as biotechnology, the lesson for the practitioner becomes one of exhibiting an abundance of caution in complying with the written description requirement.

In the remainder of this article, considerations for measuring the sufficiency of the written description requirement are provided. '[T]he disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention.' Crown Operations International, Ltd. v. Solutia Inc., 289 F.3d 1367, 1376 (Fed. Cir. 2002). Factors governing the 'reasonable clarity' test are as follows. First, the Supreme Court held that the claims must contain the same disclosure as the specification. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002). However, the description need not contain, in haec verba, or in exact language, the limitation of the claim. All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d 774, 779 (Fed. Cir. 2002) (holding that a claim limitation directed to heating thermoplastic with an 'original unidentifiable mass' still satisfied the written description requirement even though the language 'original unidentifiable mass' did not appear explicitly in the specification). How-ever, in Festo, the Supreme Court explicitly decided that, 'What is claimed by the patent application must be the same as what is disclosed in the specification.' Festo, 535 U.S. at 736.

Second, if clarity exists as to what the invention is not, then the description requirement may be satisfied. The All Dental court held that it was clear that the 'original unidentifiable mass' limitation clearly excluded heating thermoplastic, which has an identifiable shape and thus was sufficient. All Dental, 309 F.3d at 779. Third, short disclosures do not automatically violate the description requirement. In re Hayes Microcomputer Products Inc. Patent Litigation, 982 F.2d 1527 (Fed. Cir. 1992). The adequacy of the description requirement involves the content related to the particular invention, not the length. Id. at 1534.

Fourth, reasonable clarity will be found where one of ordinary skill in the art will 'immediately discern the limitation' of the claims. Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 558-59 (Fed. Cir. 1994). For example, where a specification includes the embodiment of measuring a pound of flesh by a counterweight of a pound of iron, claims directed to a pound of 'metal weight' or 'weight' for the counterweight would be immediately discernable as part of the invention. In re Rasmussen, 650 F.2d 1212, 1215 (C.C.P.A. 1981). Contrasting this with the decision in Lockwood v. Am. Airlines Inc., 107 F.3d 1565 (Fed. Cir. 1997), 'A description which renders obvious the invention … is not sufficient.' Id. at 1572. Lockwood's patent claimed a system of multiple, self-service terminals for dispensing audio-visual sales from multiple venders. Id. at 1568. The patent claimed priority through a chain of patents to an earlier filing date. Id. However, one member patent of the chain failed to disclose a computer system connected to multiple venders. Id. at 1572. The Federal Circuit invalidated the patent because '[i]t is not sufficient for purposes of the written description requirement of '112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose. Each application in the chain must describe the claimed features.' Id.

In conclusion, it behooves patent applicants to err on the side of providing a more thorough description of their invention. The Federal Circuit has yet to outline the precise bounds of the written description requirement. Therefore, applicants should make every effort to fully describe all aspects of their invention, leaving little to guesswork.

Jack L. Chen is an associate in the New York office of Kenyon & Kenyon LLP. He can be reached at 212-908-6207.

In recent years, cases such as Enzo Biochem, Inc. v. Gen-Probe, Inc. , 323 F.3d 956 (Fed. Cir. 2002) (' Enzo ') and University of Rochester v. G.D. Searle and Co., Inc. , 375 F.3d 1303 (Fed. Cir. 2004) ('Rochester') have fueled an ongoing debate over whether the first paragraph of 35 U.S.C. '112 includes a written description requirement, separate and distinct from enablement and best mode. According to Judge Randall Ray Rader, Univ. of Cal. v. Eli Lilly & Co. , 119 F.3d 1559 (Fed. Cir. 1997) ('Eli Lilly') brought the written description requirement squarely to light. Rochester, 375 F.3d at 1307 (Circuit Judge Rader dissenting). This 'new' requirement creates 'enormous confusion,' not only for the courts, but also for patent drafters. Id. Because the requirement is in flux, patent practitioners should avoid overlooking the requirement or taking it too lightly.

In Rochester, a sharply divided Federal Circuit declined to rehear the district court's decision that invalidated a patent previously held by the University for failing to meet the separate written description requirement. Judge Alan David Lourie, in his concurring opinion, wrote that 'there is and always has been a separate written description requirement in the patent law.' Id. at 1305. Both Judges Richard Linn and Rader disagreed. First, '[r]eading into paragraph 1 of section 112 an independent written description requirement, divorced from enablement, sets up an inevitable clash between the claims and the written description as the focus of the scope of coverage. This is ill-advised.' Id. at 1307. Second, the Federal Circuit's issuance, withdrawal and re-issuance of the decision in the Enzo case indicated that a controversy existed over whether the written description requirement, as a separate and distinct requirement, is indeed valid. In Enzo, the Federal Circuit initially held that 'a deposit is not a substitute for a written description of the claimed invention.' Id. at 1308 (citation omitted). In so holding, the Federal Circuit applied the recently adopted requirement from Eli Lilly that a biotechnological invention must include a nucleotide-by-nucleotide recitation of its structure. Accordingly, the Enzo court invalidated the claims to a polypeptide detector, even though the patent described the polypeptides and three samples of the specifically claimed material were deposited at the American Type Culture Collection. Rochester, 375 F.3d at 1308. The Federal Circuit hastened to withdraw the initial Enzo decision following a firestorm of controversy and reversed the result. Id.

Despite the majority's decision not to rehear the Rochester case en banc, it still called for the confusion surrounding the written description requirement to be settled. Judge Timothy B. Dyk, in a concurring opinion, stated, 'In my view we have yet to articulate satisfactory standards that can be applied to all technologies.' Id. at 1308. Judge Pauline Newman, in her dissent, stated, 'This question has percolated enough; it is ripe for en banc resolution.' Id. at 1307. Whether the Federal Circuit will continue to invalidate patents for failing to comply with the separate written description requirement, revert to a more traditional role 'to prevent applicants from adding new inventions to an older disclosure,' or even limit the scope of the requirement to fields such as biotechnology, the lesson for the practitioner becomes one of exhibiting an abundance of caution in complying with the written description requirement.

In the remainder of this article, considerations for measuring the sufficiency of the written description requirement are provided. '[T]he disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention.' Crown Operations International, Ltd. v. Solutia Inc. , 289 F.3d 1367, 1376 (Fed. Cir. 2002). Factors governing the 'reasonable clarity' test are as follows. First, the Supreme Court held that the claims must contain the same disclosure as the specification. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. , 535 U.S. 722, 736 (2002). However, the description need not contain, in haec verba, or in exact language, the limitation of the claim. All Dental Prodx, LLC v. Advantage Dental Prods., Inc. , 309 F.3d 774, 779 (Fed. Cir. 2002) (holding that a claim limitation directed to heating thermoplastic with an 'original unidentifiable mass' still satisfied the written description requirement even though the language 'original unidentifiable mass' did not appear explicitly in the specification). How-ever, in Festo, the Supreme Court explicitly decided that, 'What is claimed by the patent application must be the same as what is disclosed in the specification.' Festo, 535 U.S. at 736.

Second, if clarity exists as to what the invention is not, then the description requirement may be satisfied. The All Dental court held that it was clear that the 'original unidentifiable mass' limitation clearly excluded heating thermoplastic, which has an identifiable shape and thus was sufficient. All Dental, 309 F.3d at 779. Third, short disclosures do not automatically violate the description requirement. In re Hayes Microcomputer Products Inc. Patent Litigation, 982 F.2d 1527 (Fed. Cir. 1992). The adequacy of the description requirement involves the content related to the particular invention, not the length. Id. at 1534.

Fourth, reasonable clarity will be found where one of ordinary skill in the art will 'immediately discern the limitation' of the claims. Waldemar Link, GmbH & Co. v. Osteonics Corp. , 32 F.3d 556, 558-59 (Fed. Cir. 1994). For example, where a specification includes the embodiment of measuring a pound of flesh by a counterweight of a pound of iron, claims directed to a pound of 'metal weight' or 'weight' for the counterweight would be immediately discernable as part of the invention. In re Rasmussen, 650 F.2d 1212, 1215 (C.C.P.A. 1981). Contrasting this with the decision in Lockwood v. Am. Airlines Inc. , 107 F.3d 1565 (Fed. Cir. 1997), 'A description which renders obvious the invention … is not sufficient.' Id. at 1572. Lockwood's patent claimed a system of multiple, self-service terminals for dispensing audio-visual sales from multiple venders. Id. at 1568. The patent claimed priority through a chain of patents to an earlier filing date. Id. However, one member patent of the chain failed to disclose a computer system connected to multiple venders. Id. at 1572. The Federal Circuit invalidated the patent because '[i]t is not sufficient for purposes of the written description requirement of '112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose. Each application in the chain must describe the claimed features.' Id.

In conclusion, it behooves patent applicants to err on the side of providing a more thorough description of their invention. The Federal Circuit has yet to outline the precise bounds of the written description requirement. Therefore, applicants should make every effort to fully describe all aspects of their invention, leaving little to guesswork.

Jack L. Chen is an associate in the New York office of Kenyon & Kenyon LLP. He can be reached at 212-908-6207.