Trilateral Project 24.1-Biotechnology 006

The conditions for patentability are contained in the Patent Act, codified as Title 35 of the United States Code. According to Section 101 of Title 35:

---Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.---

As a result, an invention must fit into one of the four categories of invention. The invention must also be useful. The threshold for usefulness often called utility is more fully described in the Utility Examination Guidelines, 60 Fed. Reg. 36, 253 (1995), reprinted with legal analysis in 50 Pat. Trademark & Copyright J. 295 (BNA 1995). Failure to fit into one of the categories or failure to be useful will elicit a rejection based upon 35 U.S.C. Section 101.

If an invention is both useful and fits into one of the four categories of invention, it must still satisfy the conditions and requirements that are delineated in Title 35. Of primary substantive importance are Sections 102, 103, and 112.

Section 102 of Title 35 considers novelty and the loss of the right to a patent. Generally, "[a] person shall be entitled to a patent unless" the invention was invented by another first; publicized or offered for sale more than a year before a patent application was filed; or the subject of a foreign patent that was filed more than a year before filing the United States Patent Application. In addition, case law holds that commercialization of an invention more than one year before filing a patent application will create a loss of right, even if the invention is not publicized. See, e.g., Metallizing Eng'g Co. v. Kenyon Bearing & Auto Parts, 153 F.2d 516, 68 USPQ 54 (2d Cir. 1946) (loss of patent rights for a trade secret used more than a year before filing a patent application).

Section 103 of the Patent Act considers whether the invention would have been obvious to the ordinary or average individual practicing in the technology of the invention. The section holds that a patent will not be granted:

---Though the invention is not identically disclosed or described as set forth in section 102 ... if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which [the subject matter of the invention] pertains.---
As the statute indicates, the obviousness of an invention is judged at the time the invention was made and is directed to determining whether the differences between the claimed subject matter and the prior art would have been obvious to one of ordinary skill in the art.

The Supreme Court clarified the obvious determination in Graham v. John Deere Co., 383 U.S. 1 (1966), when the Court enunciated the three part test used to determine whether an invention is obvious. According to that test, the fact finder must: (1) determine the scope and content of the prior art; (2) determine what is different between the prior art and the claimed invention; and (3) determine the level of ordinary skill in the art. The Court also indicated a number of additional indicia of nonobviousness, such as commercial success, that could also be factored into the determination.

Even if an invention is novel and nonobvious, the specification must contain a written description of the invention 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 of carrying out his invention". 35 U.S.C. Section 112, first paragraph. Accordingly, Section 112, first paragraph has three distinct requirements: (1) a written description of the invention; (2) sufficient detail to enable any person of skill in the appropriate art to make and use the written description of the invention; and (3) disclosure of the best mode contemplated by the inventor for carrying out the invention.

The written description requirement is satisfied if the description conveys to those skilled in the art that the applicant invented the later claimed subject matter. In re Wilder, 736 F.2d 1516, 1520, 222 USPQ 369, 372 (Fed. Cir. 1984). The enablement requirement is satisfied if the disclosure would permit an individual that is familiar with that area of expertise to make and use the claimed invention without undue experimentation. The best mode requirement is satisfied if the inventor discloses the best manner of practicing the invention that the inventor contemplated at the time of filing.

The final major substantive requirement for obtaining a patent is satisfaction of 35 U.S.C. Section 112, second paragraph. This is a requirement that the applicant clearly point out and distinctly claim the invention. It permits others in the art to know the edges or bounds of the claimed intellectual property.