United States: The CCPA's Lasting Impact On U.S. Patent Law – An Examination Of CCPA Enablement Decisions

Introduction

The enablement requirement is a bedrock principle of the U.S. patent system. In exchange for a 20-year monopoly on a claimed invention, the public gets a description of the invention. Specifically, the enablement requirement codified in 35 U.S.C. § 112, ¶ 1 requires that a disclosure enable a person of ordinary skill in the art ("POSA") to make and use the claimed invention. It is generally accepted that this description must teach a POSA to make and use a claimed invention without "undue experimentation." Should a disclosure be insufficient so as to require "undue experimentation," the claimed invention is not properly enabled.

While modern case law continues to define the more nuanced questions regarding enablement, much of our core understanding of the requirement comes from cases decided by the United States Court of Customs and Patent Appeals ("CCPA"). The cases discussed below remain good law today and should be considered when making patent prosecution and litigation decisions that rest on the enablement requirement.¹

Case Summaries

In re Robins, 429 F.2d 452 (CCPA 1970)

In In re Robins, the patent applicant filed an appeal from a decision by the Patent Office Board of Appeals ("the Board") affirming a rejection of claims 19-28 directed to "a process for producing solid, non-cellular urethane polymers and to the resulting product." Id. at 453-54. The examiner originally rejected the claims as unduly broad and not supported by the disclosure. Id. The examiner explained this position by stating that the applicant had not disclosed a sufficient number of compounds falling within the scope of the claims. Id. The specification stated that:

"[T]wo compounds which are readable on the claims (i.e., on which the claims read): phenyl mercury acetate and phenyl mercury hydroxide. On page 5 of the specification, appellant discusses in broad terms the catalyst contemplated. Note that appellant states that the 'mono-organo' portion of the catalyst may be 'alkyl' or 'aryl.' The only example of 'aryl' is phenyl. There are no examples of 'alkyl.' Note that no particular meaning for 'aryl' has been ascribed to in the specification . . . The instant specification contains no examples of alkyl. The mono-organo portion of the catalysts is not limited to 'aryl' and 'alkyl.' Thus an (any?) organic radical is included within appellant's recitations."

Id. at 455.

The board affirmed the examiner's rejection. It stated found the term 'organo' "to be far broader than is warranted by the compounds disclosed." Id. at 455-56.

On appeal, the CCPA reversed the rejection stating that "inasmuch as the specification contains a statement of appellant's invention which is as broad as appellant's broadest claim, and inasmuch as the sufficiency of the specification to satisfy the 'best mode' requirement of § 112 and to enable one skilled in the art to practice appellant's process as broadly as it is claimed has not been questioned." Id. at 456. The CCPA explained that "representative compounds are not required by the statue and are not an end in themselves." Id. at 457. Rather "inclusion of a number of representative examples in a specification is one way of demonstrating the operability of a broad chemical invention . . . [and] it also is one way of teaching how to make and/or how to use the claimed invention, thus satisfying that aspect of § 112."

In re Gardner, 475 F.2d 1389 (CCPA 1973)

In In re Gardner, the examiner rejected a claim directed to a class guanidinoalkyl-1:4-benzodioxan compounds used as antihypertensive agents. Id. at 1390. The examiner described the claim as "'too broad' in view of the lack of support in the specification for all the compounds encompassed by the substituent group R₁and the floating position thereof." Id. The Board affirmed the rejection explaining that the examiner's rejection was clearly based on the requirements of § 112.

The CCPA framed the Board's primary contention being "that a reasonable basis exists for doubting that all of the compounds encompassed by claim 2 have the asserted utility, i.e. antihypertensive activity." Id. at 1391. The quantitative properties became the crux of the rejection:

"The new 1:4-benzodioxan derivatives of the invention have been found to exhibit varied pharmacological activity in the animal body. Thus compounds falling within the definition of Formula 1 have been found to exercise pharmacological actions on the peripheral nervous system, particularly on the sympathetic and parasympathetic nervous systems. For instance, some of the compounds such as 2-1'-guanidinoethyl-1:4-benzodioxan have very prounounced adrenergic nerve blocking activity, some such as 5:8-dimethyl-2'-guanidinometyl-1:4-benzodioxan have pronounced ganglion blocking activity and antihistaminic activity. All have these activities to a certain degree."

Id.

The CCPA cited precedent to explain that "there is no requirement in § 112 that all of the claimed compounds have the same degree of utility." Id. Rather "[s]ome antihypertensive activity coupled with knowledge as to the employment of this activity is all that is necessary to satisfy the how-to-use requirement." Id.

The CCPA concluded that the Patent Office did not show adequate support for its doubts as to the compound's utility because "the only reasonable interpretation that can be given to the concluding sentence of the controversial paragraph is that all of the compounds possess each of the aforementioned activities, although in varying degrees." Id. The CCPA reversed the Board's decision.

Id.

In re Angstadt, 537 F.2d 498 (CCPA 1976)

In In re Angstadt, the Board affirmed the rejection of claims in an application entitled "Organometallic Complexes as Alkylaromatic Oxidation Catalysts." Id. at 499. The applicant appealed this decision to the CCPA.

The CCPA explained that "many chemical processes, and catalytic processes particularly, are unpredictable . . . and that the scope of enablement varies inversely with the degree of unpredictability involved." Id. at 502. The CCPA found the process at issue to be particularly unpredictable as evidenced by the specification's forty examples. Id. Describing the question as "whether in an unpredictable art, section 112 required disclosure of a test with every species covered by a claim," the CCPA explained that "[t]o require such a complete disclosure would apparently necessitate a patent application or applications with 'thousands' of examples or the disclosure of 'thousands' of catalysts." Id.

The CCPA stated that "each case must be determined on its own facts." Id. The facts before the CCPA included providing "those skilled in this art with a large but finite list of transition metal salts from which to choose in preparing such a complex catalyst" and carrying out "40 runs using various transition metal salts and hexalkylphosphoramides." Id. at 503. Ultimately, the CCPA concluded that a POSA would have been enabled by the specification and its working examples. Id.

The CCPA also engaged in an analysis of undue experimentation. The Court explained that "[t]he key word is 'undue,' not 'experimentation.'" Id. at 504. Ultimately the Court held that "the evidence as a whole, including the inoperative as well as the operate examples, negates the PTO position that persons of ordinary skill in this art, given its unpredictability must engage in undue experimentation to determine which complexes work." Id.

In re Marzocchi, 439 F.2d 220 (CCPA 1971)

In In re Marzocchi, the claims related to glass fibers and vinyl resins. Claims 6 and 12 recited the use of "polyethyleneamine" as the adhesion enhancer and were rejected for lack of enablement. The Board upheld the rejection.

The CCPA reversed, however, finding that the Patent Office did not explain its concerns over the breadth of the description. Id. at 223. Importantly, the CCPA noted that the specification is presumed enabling unless there is a reason for doubt:

As a matter of Patent Office practice, then, a specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. Assuming that sufficient reason for such doubt does exist, a rejection for failure to teach how to make and/or use will be proper on that basis; such a rejection can be overcome by suitable proofs indicating that the teaching contained in the specification is truly enabling.

Id.

In this case, "[a]ccepting . . . that the term is a generic one, its recitation must be taken as an assertion by appellants that all of the 'considerable number of compounds' which are included within the generic term would, as a class, be operative to produce the asserted enhancement of adhesion characteristics. Id. That is, would polyethyleneamines work as an adhesion enhancer? "The first paragraph of § 112 requires nothing more than objective enablement." Id.

The CCPA found nothing in the record sufficient for questioning the accuracy of appellants' teaching that any polyethyleneamine will function to accomplish the asserted result. Id. at 224. Therefore, claims 6 and 12 must be held to be supported by a disclosure. Id. The rejection of claims 6 and 12 was reversed.

Conclusion

These cases are just some of the precedents that remain as good law from the CCPA days. Important principles in the context of analyzing enablement such as undue experimentation are grounded in many of these cases. These cases, along with the many other CCPA decisions that are still good precedent, suggest that while the law is always changing, it is grounded in decisions and rationale with deep roots. While the CCPA may no longer be with us, its decisions and their effects stay with us today.

Footnote

1 The vast majority of CCPA decisions have not been overruled by the CCPA or overturned by an en banc Court of Appeals for the Federal Circuit ("CAFC") and thus remain binding precedent. See South Corp. v. U.S., 690 F.2d 1368, 1369 (Fed. Cir. 1982).

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