Authored by Denise W. DeFranco
There is a debate within the patent law community, among patent prosecutors, litigators, sitting judges on the United States Court of Appeals for the Federal Circuit (Federal Circuit), and others over whether 35 U.S.C. § 112, paragraph 1 requires a patent applicant to meet two distinct tests—one requiring that the specification describe the manner and process of making and using the invention, and a second requiring that the specification enable one skilled in the art to make and use the invention.1
This Article describes the current state of the law and illuminates the essence of the debate. No fewer than three different positions have been articulated by the judges of the Federal Circuit.2 One position is that there should be no separate enablement requirement under any circumstances. Adoption of this position would require reversing patent law precedent from the Federal Circuit and its predecessor court, the United States Court of Customs and Patent Appeals (CCPA), dating back to 1967. A second position states that there are always separate written description and enablement requirements. This position follows the current state of Federal Circuit law. The final position stakes out a middle ground, requiring a separate written description requirement only when a patentee is attempting to gain the benefit of an earlier filing date for its current claims. This position would essentially return the law to its state as of 1997, before the controversial Regents of the University of California v. Eli Lilly & Co.3 decision—the decision that began the present debate.
I. The Enablement Requirement of 35 U.S.C. § 112, Paragraph 1
A. The Legal Standard
35 U.S.C. § 112 sets forth the requirements for the specification of a patent application.4 Paragraph 1 of 35 U.S.C. § 112 provides:
The specification shall contain a written description of the invention, and of the manner and process 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 use the same . . . .5
Under current case law, a patent specification must be enabling such that one skilled in the art would be able to make and use the invention as claimed after reading the specification.6 Whether a specification is enabling is a question of law.7 Enablement is judged at the time of the invention-that is, as of the application filing date.8
A specification is enabling when undue experimentation is not required to make and use the invention.9 A determination of whether undue experimentation is required must take into consideration the factors enumerated in In re Wands:10
(1) [T]he quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability . . . of the art, and (8) the breadth of the claims.11
Applying the law of enablement and the Wands factors, the Federal Circuit has on several occasions found claims invalid for lack of enablement.12 Several cases are explained here to illustrate the court's application of the enablement requirement.
B. In re Vaeck—Disclosure of a Few Species Does Not Necessarily Enable a Broad Genus
In In re Vaeck,13 the United States Patent and Trademark Office (USPTO) Board of Patent Appeals and Interferences (Board) affirmed the Examiner's rejection of Vaeck's claims under 35 U.S.C. § 112, first paragraph, for lack of enablement.14 The Federal Circuit affirmed in part and reversed in part.15
The claimed invention was "directed to the use of genetic engineering techniques" to produce proteins that are toxic to disease-causing insects.16 Specifically, the claims were directed to a gene capable of being expressed in cyanobacteria cells, comprising a DNA promoter effective for expressing a DNA fragment in a cyanobacterium and a DNA fragment coding for an insecticidally active protein.17
The specification of the patent application disclosed "two . . . sources of insecticidal protein[,] and nine genera of cyanobacteria . . . as useful hosts."18 The Examiner rejected the claims under 35 U.S.C. § 112, first paragraph, for lack of enablement.19 The Examiner stated that one skilled in the art would be required to engage in undue experimentation to practice the claimed invention, in light of "the unpredictability in the art, the breadth of the claims, the limited number of working examples" disclosed, and "the limited guidance provided in the specification."20 As support for his rejection, the Examiner stated that although there are 150 different genera of cyanobacteria, the specification disclosed only nine, the working examples employed only one, and the claims were not limited to any particular cyanobacteria at all.21 The Board affirmed the Examiner's decision.22
The Federal Circuit affirmed the Board's decision as to certain claims, concluding that there was "no reasonable correlation between the [applicant's] narrow disclosure . . . and the broad scope of protection sought in the claims," especially in light of the extreme unpredictability of the art at the time of the invention.23 The court reversed the Board on two claims that were limited to a particular cyanobacterium.24
The court was quick to note that "applicants are not required to disclose every species [that their claims encompass], even in an unpredictable art."25 The disclosure must, however, teach those skilled in the art how to make and use the invention "as broadly as it is claimed."26 This requires the specification to guide one skilled in the art to those specific species, "among all those encompassed by [a] claimed genus," which "possess the disclosed utility."27 Consequently, the level of disclosure may be greater where the claimed subject matter represents an unpredictable art.28
C. National Recovery Technologies—Disclosure Must Explain How to Achieve the Claimed Result
Another exemplary case is National Recovery Technologies, Inc. v. Magnetic Separation Systems, Inc.29 The district court granted summary judgment to defendant Magnetic Separation Systems on the ground that the claims of the patent at issue were invalid for lack of enablement.30 The Federal Circuit affirmed the decision.31
The patent at issue was directed to a method for "separating recyclable plastic materials . . . by using . . . electromagnetic radiation."32 Polyvinyl chloride (PVC) and polyester (PET) containers look very similar but have different chemical properties; therefore, it is desirable to separate them for recycling purposes.33 These different chemical properties allow PVC and PET containers to absorb different amounts of electromagnetic radiation, and the claimed invention took advantage of their differential radiation absorption rates to differentiate between the containers.34
At the time of the invention, it was well known to those skilled in the art that PVC containers absorb more electromagnetic radiation than PET containers of the same thickness.35 When less radiation is transmitted through a container—that is, more radiation is absorbed by the material—it is assumed the container is made of PVC rather than PET.36 The converse is also true.37 Among the drawbacks in the prior art, one was that prior art systems were unable to take into account varying thicknesses in the walls of the containers being separated.38 Where a "PET container is significantly thicker than [a] PVC container, or where the . . . radiation passes through many layers of PET . . . before detection, the detected transmittance level can be . . . lower than that ofa PVC container."39 These variances "can potentially cause a PET container to be misclassified as a PVC container."40
The patent specification disclosed a preferred embodiment whereby containers advance along a conveyor.41 "Each container is irradiated with a . . . beam of electromagnetic radiation."42 Detectors positioned below the conveyor measure the intensity of the radiation that passes through the containers.43 A microprocessor then compares the "detected values to preset thresholds to classify the container as being made of" PVC or PET.44 "The containers are then mechanically separated on this basis."45
The specification also addressed "the problem of misclassification due to irregularities in container thickness."46 The patent stated that containers would be irradiated at several different points, with numerous "intensity measurements . . . recorded for each container."47 The microprocessor would then compare the transmittance measurements for different portions of a single container to each other and selects a subset of the highest readings for processing.48 One drawback to this method is that the orientation of any given container on the conveyor is unpredictable.49 Additionally, a container may be damaged in such a way that its thickness is difficult to determine because of resulting irregularities.50 Thus, it is not always possible to accurately distinguish between PET and PVC containers simply by selecting the highest transmittance readings.51 A solution is to measure only regular portions of the container.52
Claim 1 of the patent at issue was a method to distinguish and separate containers that absorb different levels of electromagnetic radiation.53 Among other steps, the claim included "selecting for processing [the] process signals which do not pass through irregularities in the bodies of said material items."54 The district court held that claim 1 was not enabled because the specification did not teach one of skill in the art how to select for processing the signals that did not pass through irregularities in the containers.55
The Federal Circuit stated that a claim is not invalid "simply because the invention does not work perfectly under all conditions."56 The specification, however, must enable one skilled in the art "to practice the claimed invention without undue experimentation."57 The court, therefore, must look at the specification, the claims, and the level of skill in the art.58 The Federal Circuit found that the claim was broader than what was enabled by the specification.59
The specification directed one skilled in the art to use measurements with the highest transmission rates.60 The Federal Circuit termed the described method "a good proxy" for measurements that do not pass through irregularities.61 The court, however, reasoned that "enabling a proxy for the claimed invention" does not enable "the claimed invention itself."62 The specification here only "approximate[d] the claimed function."63 In fact, the specification pointed out that it is not feasible to actually determine the location of irregularities in the containers.64 Additionally, as of the filing date of the application, there was no known method available in the public record for identifying irradiation that passed through irregularities.65 Thus, the specification was not enabling as to the "full scope of the invention" as claimed.66
II. The Written Description Requirement of 35 U.S.C. § 112, Paragraph 1
A. The Legal Standard
35 U.S.C. § 112, paragraph 1 also requires that a patent specification must contain a written description of the invention.67 Whether an invention is sufficiently described in the specification is a question of fact.68 Several cases are explained below to illustrate application of the written description requirement.
B. Vas-Cath Inc. v. Mahurkar—Disclosure Must Demonstrate Possession of the Invention
The current standard for the written description requirement is set forth in Vas-Cath Inc. v. Mahurkar.69 In Vas-Cath, the issue was whether claims of a utility patent were entitled to the benefit of the filing date of a related design application such that the applicant could overcome an intervening § 102(b) reference.70 Vas-Cath alleged that the drawings in the design application did not provide a sufficient written description for the claims in the utility application under 35 U.S.C. § 112, paragraph 1.71 The court, however, concluded that the drawing in a design application can provide adequate support for a claim in a later filed utility application.72 The Federal Circuit stated that "the description must clearly allow persons of ordinary skill in the art to recognize that [the applicant] invented what is claimed"73 and "the test for sufficiency of support in a parent application is whether the disclosure of the application relied upon 'reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.'"74
For further clarification, the court reaffirmed an earlier case that recognized that 35 U.S.C. § 112, paragraph 1
requires a "written description of the invention" which is separate and distinct from the enablement requirement. The purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the applicant must also 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. The invention is, for purposes of the "written description" inquiry, whatever is now claimed.75
Since Vas-Cath, a large number of Federal Circuit panels have considered whether later filed or broadened claims meet the written description requirement of 35 U.S.C. § 112, paragraph 1.76 Because the question of whether a claim is supported by the specification is a question of fact, the cases tend to turn on very specific factual issues.77 Some written description cases have turned on whether disclosure of a single embodiment as the invention limits the permissible scope of the claims to that embodiment.78 This so-called essential element test, however, has become increasingly disfavored.79
C. Eli Lilly—Sowing the Seeds for the Debate
In Regents of the University of California v. Eli Lilly & Co.,80 the Federal Circuit broke new ground by holding that certain originally filed claims were invalid for a lack of written description because the claimed invention was not adequately described in the specification.81 The specification described cDNA encoding only rat insulin, whereas the claims were directed to cDNA encoding mammalian and vertebrate insulin and to cDNA encoding human insulin.82 Thus, while the disclosure may have been enabling, it was not sufficient to describe the invention as claimed.83
Eli Lilly articulated several examples of what may or may not constitute an adequate description of a biochemical invention under 35 U.S.C. § 112, paragraph 1.84 For example, "a precise definition, such as bystructure, formula, chemical name, or physical properties" or a description of the claimed DNA itself will suffice.85 However, just the name "cDNA" or the name of a type of material, without knowing what the material is, will not suffice.86
Following the statement in Eli Lilly that an "adequate written description of a DNA . . . 'requires a precise definition, such as by structure, formula, chemical name, or physical properties,'"87 the USPTO stated that the original claim doctrine (that is, originally filed claims provide their own written description) was repudiated in Eli Lilly.88
D. Enzo Biochem—Fodder for the Debate
In Enzo Biochem, Inc. v. Gen-Probe Inc.,89 the Federal Circuit, as in Eli Lilly, faced the issue of whether originally filed claims met the written description requirement.90 The issue before the Enzo court was whether the district court properly granted summary judgment of invalidity for failure to meet the written description requirement in light of the fact that the patentee had deposited biological material in a public depository.91 The Federal Circuit vacated and remanded the case, finding that there were genuine issues of material fact to be resolved.92
The deposit requirement was created to allow those skilled in the art to practice the invention after expiration of the patent.93 Biological materials that cannot be made or obtained without undue experimentation must be deposited in a public depository to satisfy the enablement requirement.94 The issue in Enzo was whether these deposits, which were intended to satisfy the enablement requirement, could also describe the claimed invention to satisfy the written description requirement.95 The court held that while the deposit requirement was created to fulfill the enablement requirement, the same material may satisfy the written description requirement as well.96 The case was remanded for the district court to determine whether the deposited material demonstrated possession of the generic scope of the claims.97
E. University of Rochester—Still More Fodder for the Debate
In University of Rochester v. G.D. Searle & Co.,98 (Rochester 1) the Federal Circuit, in an opinion written by Judge Lourie, once again considered whether originally filed claims met the written description requirement.99 The University of Rochester's family of inventions was directed to methods for identifying certain non-steroidal anti-inflammatory drugs (NSAIDs).100 Specifically, the patent was directed to methods for identifying NSAIDs which selectively inhibit the activity of certain enzymes (COX-2 inhibitors) and not others (COX-1 inhibitors).101 The patent at issue claimed a method for selectively inhibiting COX-2 activity in humans by administering NSAIDs.102
The district court found that the specification did not disclose any compound that selectively inhibited activity of the COX-2 gene, as required by the claims.103 Thus, summary judgment of invalidity was granted for lack of written description.104 The Federal Circuit affirmed because the University of Rochester "had neither possession nor knowledge of such a compound [to selectively inhibit COX-2 activity]."105 The court also held that whether a compound is claimed or a method that requires the use of a compound is claimed, the inventor must describe that compound.106 The description must establish that the applicants were "in possession of" the claimed invention, including all elements and limitations.107
On appeal, the patentee argued as a threshold issue that enablement and the written description requirement do not exist independently of each other.108 The Federal Circuit disagreed, stating that its "precedent recognizes a written description requirement."109 First, the court noted the language of the statute itself, which contains separate written description and enablement requirements: (1) "[t]he specification shall contain a written description of the invention;" and (2) "[t]he specification shall contain a written description . . . of the manner and process of making and using [the invention] in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same."110 Second, the court relied on the Supreme Court decision in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.111 The Festo Court, in listing the statutory requirements which must be met before a patent can issue, stated that the application must describe and enable under § 112.112
The Rochester I court held that there are, and long have been, two distinct requirements of written description and enablement.113 The court also made clear that a different standard under 35 U.S.C. § 112 does not apply to DNA-based inventions or inventions related to genetic material.114 The court stated that the application of the written description to originally filed claims was not a revolutionary undertaking:
[S]uch a holding [in Eli Lilly] was not precluded by statute or precedent. New interpretations of old statutes in light of new fact situations occur all the time. . . . [I]t regularly happens in adjudication that issues do not arise until counsel raise them, and, when that occurs, courts are then required to decide them.115
III. The Debate—One Requirement or Two?
A. The Enzo Hullabaloo in 2002
Judge Lourie wrote the decision in Eli Lilly, which first applied the written description requirement to originally filed claims.116 Since then, there has been a debate among the judges of the Federal Circuit over the proper application of the written description requirement. The debate manifested itself clearly in the Enzo cases. Judge Lourie wrote both the Enzo I decision, affirming summary judgment of invalidity for failure to satisfy the written description requirement,117 and the Enzo II decision.118 When the patentee requested that the panel rehear the case, a non-panel judge requested that the case be reheard en banc.119 Perhaps because of the threat of en banc review, the panel reheard the case in Enzo II, vacated its first opinion, and reversed and remanded for a proper application of the written description requirement.120
On the same day that the court handed down the Enzo II opinion, the court also issued an order denying rehearing en banc—Enzo III.121 Judge Lourie wrote a concurrence in the court's decision not to hear the case en banc in Enzo III.122 In it he explained that the "law [on written description] is sound and does not need revision" by the en banc court.123 Judge Lourie relied in part on the plain language of the statute.124 He also referred, as he did in Rochester I, to the Supreme Court's Festo decision, which states that a patent application must describe and enable the claimed invention.125
Judge Newman joined in Judge Lourie's opinion.126 She and Judge Dyk also wrote separate concurring opinions in the denial of rehearing en banc.127 Judge Newman expressed her opinion regarding the importance of the written description requirement.128 Judge Dyk stated that the opinions of the various judges "raise important and interesting questions, including questions concerning the correctness of our earlier decision in [Eli Lilly]."129 He concluded, however, that the appeal following Enzo II was "not the appropriate occasion for en banc review."130
Judge Rader, joined by Judges Gajarsa and Linn, dissented from the Federal Circuit's decision not to rehear Enzo II en banc.131 In his dissenting opinion, Judge Rader expressed his view that the Federal Circuit should reverse Eli Lilly because the written description requirement should be applied only to newly added claims to determine entitlement to priority.132 Judge Rader asserted that Enzo II disregarded the plain meaning of 35 U.S.C. § 112, paragraph 1; namely, that "an adequate written description assures that others can make and use the invention."133 Judge Rader further reasoned that Enzo II ignored over 30 years of case law that applied the written description requirement only to newly added claims.134 He concluded that Vas-Cath correctly stated the written description requirement as applied in the priority context and that the written description requirement was carved out by the CCPA in In re Ruschig135 in order to police priority and the addition of new matter into the claims.136 As applied to originally filed claims, however, Judge Rader stated that the written description requirement "cannot depart from the enablement test without replacing it."137
Judge Rader asserted that the Eli Lilly court should have rejected the claims at issue on enablement grounds because the specification did not teach one skilled in the art how to make human insulin cDNA.138 Additionally, according to Judge Rader, the patent contained "claims whose scope far exceeds the patent's enabling disclosures."139 Judge Rader also opined that the written description requirement as applied to originally filed claims was stricter than the enablement requirement and, thus, effectively replaced enablement challenges by accused infringers.140 The problem, according to Judge Rader, was that the written description is ill equipped to address the issues that the enablement requirement currently addresses.141
Judge Linn also wrote a dissenting opinion from the order denying rehearing en banc of Enzo II.142 In that opinion, he expressed the view that written description as a separate requirement is relevant to priority.143 Enablement, on the other hand, is relevant to the sufficiency of the disclosure.144 Judge Linn asserted that the requirement that an inventor demonstrate he had possession of the invention is a "way to measure entitlement of later filed claims to an earlier priority date."145 "It was not and should not," according to Judge Linn, "be a test for sufficiency of disclosure."146 Originally filed claims are entitled to the filing date, in his view, because the claims themselves, "filed as a part of the original application[,] provide their own written description."147 Judge Linn suggested the Eli Lilly and Enzo II courts asked the wrong question when they inquired whether the written description disclosed what the invention is, or merely what it does.148 He asserted the proper inquiry should be whether the description describes the invention, as recited in the claims, "in terms that are sufficient to enable one of skill in the art to make and use the claimed invention."149
B. The Moba Missives—The Judges Fail to Agree in 2003
In 2003, the Federal Circuit decided a rather mundane patent dispute, Moba, B. V. v. Diamond Automation, Inc.150 The per curiam opinion addressed the claim construction issues that were at the heart of the dispute between the parties and then, under the substantial evidence standard, the court perfunctorily affirmed the jury's finding that the patent was not invalid for failure to satisfy the written description requirement.151
Judge Rader nonetheless wrote a concurring opinion expressing his view that the Moba decision perpetuated an error started by the Eli Lilly case.152 Judge Rader summarized his view of the Eli Lilly rule as follows:
It defies over thirty years of case law. It finds no specific support in any statutory language. It creates a technology-specific rule in a technology-neutral statute. It distorts the statute's rules for adequate disclosure of inventions. It complicates biotechnology patent drafting to the point of near impossibility and invites invalidating mistakes. It prices non-corporate inventors out of some biotechnological invention markets. Last, but not least, it burdens both trial and appellate courts with unnecessary and confusing procedures in otherwise simple cases . . . .153
Circuit Judge Bryson also entered the fray in Moba.154 In a separate concurrence, he suggested that In re Ruschig is perhaps the case which needs to be revisited, not Eli Lilly—for which he was a panel member.155 In Ruschig, the court held for the first time in the context of the current Patent Act that 35 U.S.C. § 112, paragraph 1 contained a written description requirement separate and distinct from the enablement requirement.156 Judge Bryson based his argument in Moba on the fact that there is no support in the statute for restricting the written description requirement to priority disputes.157 He stated that the real issue was whether the statute could be correctly interpreted to contain a separate written description requirement at all.158 If there were such a requirement, there would be no basis for restricting its application.159
C. The Rochester Escalation—The Debate is Further Explored in 2004
The Rochester case, which was described above, also drew a flurry of additional opinions by members of the court.160 In denying the patentee's petition for rehearing en banc, the court issued six separate opinions.161 As could have been predicted, Judge Lourie concurred in the denial of rehearing en banc, and Judges Rader and Linn dissented from the denial of rehearing en banc.162
Circuit Judge Dyk also issued an opinion that was consistent with the concurrence he wrote in Enzo III.163 Specifically, Judge Dyk expressed the view that "this is neither the right time, nor the right case, in which to consider those difficult questions."164 This time, however, Judge Dyk went a little further. Whereas in his earlier concurrence in Enzo III, Judge Dyk simply stated that the opinions of the various judges "raise important and interesting questions, including the correctness of our earlier decision in [Eli Lilly],"165 in this concurrence, Judge Dyk unequivocally stated his view that the statute contains a written description requirement "in the context of [both] priority and validity disputes."166 Judge Dyk also admitted that he does not necessarily endorse the "existing written description jurisprudence."167 In his view, the Federal Circuit has "yet to articulate satisfactory standards that can be applied to all technologies."168
There was another change too. Judge Newman, who concurred in the decision to deny rehearing en banc in Enzo III,169 wrote in support of the dissent.170 Although she agreed with Judge Lourie on the merits of the debate, in Rochester she stated that the issue should be decided en banc:
I respectfully dissent from the court's decision not to resolve en banc the burgeoning conflict in pronouncements of this court concerning the written description and enablement requirements of the Patent Act. This question has been promoted from simple semantics into a fundamental conflict concerning patent scope and the support needed to claim biological products. The appropriate forum is now the en banc tribunal, not continuing debate in panel opinions applying divergent law.171
With Judge Newman newly in the camp asserting that the en bane court should revisit the law of written description and enablement, and with Judge Dyk expressing his willingness to revisit the issue, it seems likely that the court will consider the issue en banc when the appropriate case comes along. Is there one requirement or two? Right now, there are two, but perhaps not for long.
1 See 35 U.S.C. § 112 (2000).
2 See discussion infra Part III.
3 119 F.3d 1559 (Fed. Cir. 1997).
4 35 U.S.C. § 112 (2000).
6 See, e.g., In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991).
7 E.g., id.; Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984); see also U.S. PATENT AND TRADEMARK OFFICE, U.S. DEPT. OF COMMERCE, MANUAL OF PATENT EXAMINING PROCEDURE § 2164.01 (8th ed. 2001) [hereinafter MANUAL] ("Determining enablement is a question of law based on underlying factual findings.").
8 See Vaeck, 947 F.2d at 495; MANUAL, supra note 7, § 2164.01.
9 In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
10 858 F.2d 731 (Fed. Cir. 1988).
11 Id. at 737.
12 See, e.g., Nat'l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1192 (Fed. Cir. 1999); Vaeck, 947 F.2d at 493.
13 947 F.2d 488 (Fed. Cir. 1991).
14 Id. at 493.
15 Id. at 496.
16 Id. at 489.
17 See id. at 490.
19 Id. at 492.
20 Id. at 492-93.
21 Id. at 493, 495.
22 Id. at 493.
23 Id. at 495-96.
24 Id. at 496.
28 See id.
29 166 F.3d 1190 (Fed. Cir. 1999).
30 Id. at 1192.
38 See id.
39 Id. at 1193.
41 Id. at 1192.
46 Id. at 1193.
54 Id. at 1194 (emphasis omitted) (quotation omitted).
55 See id. at 1194, 1198.
56 Id. at 1196.
57 Id. (emphasis omitted).
60 Id. at 1197.
66 Id. at 1198.
67 35 U.S.C. § 112 (2000).
68 E.g., Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Or. 1991).
69 935 F.2d 1555, 1562-63 (Fed. Or. 1991).
70 Id. at 1559-60.
71 Id. at 1559.
72 Id. at 1565.
73 Id. at 1563 (quoting In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)).
74 Id. (quoting Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (citation omitted)).
75 Id. at 1563-64.
76 See, e.g., infra notes 78-81 and accompanying text.
77 See, e.g., Vas-Cath, 935 F.2d at 1563.
78 In Gentry Gallery, Inc. v. Berkline Corp., for example, the Federal Circuit held that the claims did not meet the written description requirement because the applicants failed to claim a limitation that was described in the specification as the only way of practicing the invention. 134 F.3d 1473, 1480-81 (Fed. Cir. 1998). In Gentry, the inventors disclosed a reclining sofa with a center console and controls to operate the recliner. Id. at 1474-75. The specification described the center console as "the only possible location" for the controls, but the claims did not limit the location of the controls in any way. Id. at 1479-80.
79 See, e.g., Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1333 (Fed. Cir. 2003) (distinguishing Gentry on the ground that the "undisclosed" element was an unclaimed method of making the claimed product); Cooper Cameron Corp. v. Kvaerner Oilfield Prods., 291 F.3d 1317, 1323 (Fed. Cir. 2002) (distinguishing Gentry on the ground that in Gentry there was "no . . . support whatever" for the broad claims, whereas the claims at issue in the instant case were supported by figures disclosing the limitation at issue); Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 993 (Fed. Cir. 1999) (distinguishing Gentry because the specification at issue in Gentry made it "crystal clear that a particular (i.e., narrow) understanding of a claim term" is essential to the invention).
80 119 F.3d 1559 (Fed. Cir. 1997).
81 Id. at 1575.
82 Id. at 1568.
83 See id.
84 See id.
85 Id. at 1566-67 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)).
86 Id. at 1568-69.
87 Id. at 1566 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)).
88 See Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1, "Written Description" Requirement, 66 Fed. Reg. 1099, 1100-01 Jan. 5, 2001) (Eli Lilly "identified a set of circumstances in which the words of the claim did not, without more, adequately convey to others that applicants had possession of what they claimed" and Examiners must examine both original and amended claims for sufficient written description.).
89 285 F.3d 1013 (Fed. Cir.) [hereinafter Enzo I], vacated, 323 F.3d 956 (Fed. Cir.) [hereinafter Enzo II], reh'g denied, reh'g en banc denied, 42 Fed. Appx. 439 (Fed. Cir. 2002) (designated non-precedential) [hereinafter Enzo III].
90 The Federal Circuit has issued three opinions in Enzo concerning the written description requirement. Originally, the Federal Circuit found that the claims at issue were invalid for lack of written description under Eli Lilly. Enzo I, 285 F.3d at 1013. On rehearing, the panel vacated its decision and remanded the case for further factual findings. Enzo II, 323 F.3d at 957. Enzo petitioned for rehearing en banc. Enzo III, 42 Fed. Appx. at 439. The request was denied, but several judges filed concurring and dissenting opinions on the propriety and wisdom of the Eli Lilly decision. Id. at 439-40.
91 Enzo II, 323 F.3d at 956.
92 Id. at 956-57.
93 See id. at 965.
94 37 C.F.R. § 1.802(b) (2004).
95 Enzo II, 323 F.3d at 962.
96 Enzo II, 323 F.3d at 966.
98 358 F.3d 916 (Fed. Cir.) [hereinafter Rochester I], reh'g denied, reh'g en banc denied, 375 F.3d 1303 (Fed. Cir.) [hereinafter Rochester II], cert. denied, 125 S. Ct. 629 (2004).
99 Id. at 919.
100 Id. at 917-18.
101 Id. at 918.
103 Id. at 919.
104 Id. The district court separately considered whether the claims were enabled and found they were not. Id.
105 Id. at 926 (quoting Univ. of Rochester v. G.D. Searle & Co., 249 F. Supp. 2d 216, 229 (WD.N.Y. 2003)).
107 Id. (quoting Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed. Cir. 1998)).
108 Id. at 920.
110 Id. at 921 (quoting 35 U.S.C. § 112 (2000)).
111 535 U.S. 722 (2002).
112 Rochester I, 358 F.3d at 921 (discussing Festo, 535 U.S. at 736).
113 See id. at 924.
114 Id. at 925.
115 Id. at 924 (quoting Enzo II, 323 F.3d 956, 971-72 (Fed. Cir.) (Lourie, J., concurring), reh'g denied, reh'g en banc denied, 42 Fed. Appx. 439 (Fed. Cir. 2002) (designated non-precedential)).
116 Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1562, 1566 (Fed. Cir. 1997).
117 See Enzo I, 285 F.3d 1013, 1015 (Fed. Cir.), vacated, Enzo II, 323 F.3d 956 (Fed. Cir.), Enzo III, reh'g denied, reh'g en banc denied, 42 Fed. Appx. 439 (Fed. Cir. 2002) (designated non-precedential).
118 See supra note 90.
119 Enzo III, 42 Fed. Appx. at 439.
120 See Enzo II, 323 F.3d at 960.
121 Enzo III, 42 Fed. Appx. at 439.
122 Id. at 440 (Lourie, J., concurring).
123 Id. (Lourie, J., concurring).
124 Id. (Lourie, J., concurring) (citing 35 U.S.C. § 112 (2000).
125 Id. at 442; Rochester I, 358 F.3d 916, 921 (Fed. Cir.) (citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002)), reh'g denied, reh'g en banc denied, Rochester II, 375 F.3d 1303 (Fed. Cir. 2002), cert. denied, 125 S. Ct. 629 (2004).
126 Enzo III, 42 Fed. Appx. at 440.
127 Id. at 444 (Newman, J., concurring); id. at 445 (Dyk, J., concurring).
128 See id. at 444-45 (Newman, J., concurring).
129 Id. at 445 (Dyk, J., concurring).
130 Id. (Dyk, J., concurring).
131 Id. (Rader, J., dissenting).
132 Id. at 449-53 (Rader, J., dissenting).
133 Id. at 445 (Rader, J., dissenting) (quotations omitted).
134 See id. at 445-46 (Rader, J., dissenting).
135 379 F.2d 990 (C.C.P.A. 1967).
136 Enzo III, 42 Fed. Appx. at 446 n.2, 447 (Rader, J., dissenting).
137 Id. at 446 n.2 (Rader, J., dissenting).
138 Id. at 449 (Rader, J., dissenting).
139 Id. (Rader, J., dissenting).
140 Id. at 451 (Rader, J., dissenting).
141 See id. at 451-52 (Rader, J., dissenting) (pointing out that enablement polices adequacy of disclosure, limits claim scope, and demarcates the line between "the visionary theorist . . . and the visionary pioneer").
142 Id. at 457 (Linn, J., dissenting).
143 Id. (Linn, J., dissenting).
144 Id. (Linn, J., dissenting).
145 Id. (Linn, J., dissenting).
146 Id. (Linn, J., dissenting).
147 Id. (Linn, J., dissenting).
148 See id. (Linn, J., dissenting).
149 Id. (Linn, J., dissenting).
150 325 F.3d 1306 (Fed. Cir. 2003) (per curiam), reh'g denied, Nos. 01-1063, 01-1083, 2003 U.S. App. LEXIS 9623 (Fed. Cir. Apr. 25, 2003), cert. denied, 540 U.S. 982 (2003).
151 Id. at 1321.
152 Id. at 1322-23 (Rader, J., concurring).
153 Id. at 1326-27 (Rader, J., concurring).
154 Id. at 1327 (Bryson, J., concurring).
155 Id. at 1327-28 (Bryson, J., concurring) (citing In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997).
156 Rusehig, 379 F.2d at 995-96. The authors note that under current law, enablement is a question of law. See, e.g., In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991). The written description requirement, on the other hand, is a question of fact. See, e.g., Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). If the Federal Circuit or Congress decides that there should only be one requirement embodied in 35 U.S.C. § 112, paragraph 1, these differing legal standards must be taken into account, lest there be great uncertainty at the district court level. See 35 U.S.C. § 112 (2000).
157 Moba, 325 F.3d at 1327 (Bryson, J., concurring).
158 Id. at 1327-28 (Bryson, J., concurring).
159 Id. at 1327 (Bryson, J., concurring).
160 Rochester II, 375 F.3d 1303, 1304 (Fed. Cir. 2002), cert. denied, 125 S. Ct. 629 (2004).
161 See id.
163 Compare id. at 1327 (Dyk, J., concurring), with Enzo III, 42 Fed. Appx. 439, 445 (Fed. Cir. 2002) (designated non-precedential) (Dyk, J., concurring).
164 Rochester II, 375 F.3d at 1327 (Dyk, J., concurring).
165 Enzo III, 42 Fed. Appx. at 445 (Dyk, J., concurring).
166 Rochester II, 375 F.3d at 1327 (Dyk, J., concurring).
167 Id. (Dyk, J., concurring).
168 Id. (Dyk, J., concurring).
169 Enzo III, 42 Fed. Appx. at 444-45 (Newman, J., concurring).
170 Rochester II, 375 F.3d at 1304 (Newman, J., dissenting).
171 Id. (Newman, J., dissenting).
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