Chapter §4.01 Introduction

• Jurisdiction: United States

§4.01 Introduction

[A] The Disclosure Requirements of 35 U.S.C. §112(a)

A U.S. patent application must satisfy three disclosure requirements identified in the first paragraph of 35 U.S.C. §112 ("Specification"), which 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, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. ¹

When patent practitioners speak of "the disclosure" or "the teaching" of a patent, they are generally referring to the information provided in the specification other than the claims (i.e., the "written description" portion of the patent, as well as any drawings).² The italicized terms in the statutory language quoted above are understood as identifying three separate requirements for the disclosure of a patent, each of which is discussed in separate chapters of this treatise: (1) enablement, (2) best mode,³ and (3) written description of the invention.⁴

These disclosure requirements pertain to the informative quality of the patent application rather than the technical merits of the invention claimed therein. Even assuming that the claimed invention is novel,⁵ nonobvious,⁶ and useful,⁷ if the patent application does not satisfy the disclosure requirements of the first paragraph of 35 U.S.C. §112 with respect to that invention, the applicant will not be granted a patent.

In re Glass presents a classic example of a presumably new and useful invention that was nevertheless denied a patent because the inventor's disclosure did not satisfy the enablement requirement.⁸ The Glass patent application claimed methods and apparatus for artificially growing high-strength crystals used to reinforce refractory materials. Although the U.S. Patent and Trademark Office (USPTO) did not challenge the novelty or utility of the claimed invention, the Court of Customs and Patent Appeals (CCPA) affirmed the agency's conclusion that the application's disclosure was fatally deficient under 35 U.S.C. §112, ¶1. Specifically, the Glass application did not disclose essential process parameters such as temperature, pressure, and vapor saturation conditions that the inventor had conceded were necessary to form the crystals. The application lacked these details either because Glass was not in possession of the information, or simply chose to maintain it as a trade secret. In either case, Glass was not entitled to a patent on his invention because his application did not satisfy the enablement requirement of 35 U.S.C. §112, ¶1.⁹

Glass involved a patent application. An issued patent, although entitled to a rebuttable presumption of validity (which includes a presumption of validity under the enablement requirement of §112, ¶1¹⁰) likewise may be invalidated during litigation for failure to satisfy the enablement requirement. The validity challenger must establish by clear and convincing evidence that the disclosure of the patent in suit does not satisfy the enablement requirement, despite the USPTO's examination and issuance of the patent.¹¹

To summarize, obtaining a patent requires not only that the claimed invention meets various statutory criteria such as novelty and nonobviousness (detailed elsewhere in this treatise) but also that the disclosure of that invention as provided in the patent application satisfies its own statutory criteria. These parallel requirements are depicted in Figure 4-1.

FIGURE 4-1. Pathway to Patentability

[B] Bargain/Exchange Theory

The enablement requirement of 35 U.S.C. §112, ¶1 implements the quid pro quo of the patent system.¹² The statute demands that the applicant's disclosure of her useful, novel, and nonobvious process, machine, manufacture, or composition of matter be of sufficient detail and clarity. The level of detail and clarity must be great enough that the U.S. federal government, in exchange for receiving that disclosure (which will ultimately be disseminated to the public) agrees to convey to the inventor a time-limited exclusive right to her invention.¹³

For various strategic and/or economic reasons, an inventor may choose not to disclose her invention through patenting and instead maintain it as a trade secret.¹⁴ Trade secret protection is significantly less powerful than patent protection, however, and is subject to loss through the inventor's failure to maintain secrecy of the information.¹⁵ The stronger rights provided by the patent system help to ensure that innovation is ultimately divulged to the public rather than suppressed.

[C] Enabling "How to Make" and "How to Use"

The enablement requirement is grounded in the Patent Act's mandate that

[t]he 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. . . . ¹⁶

Thus, the enablement provision specifies that an inventor must disclose how to make the claimed invention as well as how to use it. For example, if the claimed invention is a new pharmaceutical compound, the application must include an enabling disclosure of how to synthesize the compound and must reveal how the compound is used (e.g., in the form of a therapeutic composition to be administered to patients with a certain disease).

The ultimate goal of the enablement requirement is to put the public in effective "possession" of the invention, by providing to persons of ordinary skill in the art a detailed description of how to make and use the invention.¹⁷ The enablement requirement "is meant to ensure that, as a condition of receiving patent rights, the patentee supplies a disclosure of the invention that is sufficient to give competitors and other interested persons possession of the subject invention."¹⁸

The notion of putting the public in possession of an invention does not mean that persons must be given physical access to a tangible embodiment of the invention (such as a sample of a claimed chemical compound). Rather, those of skill in the pertinent art must be put in a position from which they themselves could make and use the invention if desired.

Noted 19th-century treatise author William C. Robinson observed that "[t]he language . . . employed in the [patent's] description . . . must be such as to place the invention fully in the possession of the public."¹⁹ Robinson explained that "public" in this sense does not mean literally every member of the general public. Rather, a patent is addressed to persons skilled in the art to which the invention pertains. "The possession of an invention by these artisans is its possession by the public for all beneficial purposes, and the inventor who renders it accessible to them makes it as available to the community as large as, in the nature of things, it could ever be."²⁰

If a member of the public were to make and/or use the invention during the term of the patent without authorization, this would amount to infringement (barring a defense such as experimental use, which the Federal Circuit has severely limited²¹). Once the patent expires, however, and with it the patentee's right to exclude others, these artisans should be in a position to make and use the invention without "undue experimentation" (a term of art detailed below). The patent's enabling disclosure thus provides guidance that such persons can follow once the patent expires and they are free to make and use the invention without liability.

The "how to use" requirement of 35 U.S.C. §112, ¶1 is closely tied to the utility requirement of 35 U.S.C. §101, discussed elsewhere in this treatise.²² If an inventor does not know the utility (or usefulness) of her invention, then logically she cannot describe how to use the invention.²³

[D] Filing Date as Measure of Disclosure Compliance/New Matter Prohibition

Whether a patent application satisfies the enablement requirement (as well as the other two disclosure requirements of 35 U.S.C. §112, ¶1, i.e., the best mode requirement²⁴ and written description of the invention requirement²⁵) is analyzed as of the application's filing date, not at some later date (such as the time of any subsequent infringement litigation in which invalidity under 35 U.S.C. §112, ¶1 is raised as an affirmative defense or counterclaim²⁶). The patent application must comply with the disclosure requirements when it is filed.²⁷ Its teachings cannot be supplemented with new information (termed "new matter") after the filing date to come into compliance with 35 U.S.C. §112, ¶1.²⁸

The statute prohibits addition of new matter to a patent application after it has been filed.²⁹ Section 132 of the Patent Act "prohibits addition of new matter to the original disclosure. It is properly employed as a basis for objection to amendments to the abstract, specifications, or drawings attempting to add new disclosure to that originally presented."³⁰

The phrase "new matter" is a rather nebulous concept, not further defined in the statute. Federal Circuit Judge Giles Rich explained new matter as

a technical legal term in patent law—a term of art. Its meaning has never been clearly defined for it cannot be.

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