Section 103(b): obviously unnecessary?

• Author: Connarn, Kristin

1. INTRODUCTION

   The Patent Act requires that a claimed invention be "nonobvious." (2) Many patent lawyers consider nonobviousness the most important of the basic patent requirements of novelty, utility, and nonobviousness. (3) The nonobviousness requirement exists to ensure that a development is a significant enough technical advance to merit the award of a patent. (4) The theory behind this requirement is that while an invention may be novel or useful, it only rises to the level of a true invention if it is more than a mere trivial change to the prior art. (5) Several years ago, 35 U.S.C. [section] 103(b), essentially a special obviousness section for certain biotechnologies was added to the Patent Act. (6) In a number of recent decisions, the Federal Circuit's definition of obviousness has tilted the scales greatly in favor of biotech patent applicants by adapting patent law to the advances in this technology-driven area of law. (7)

   This note examines whether special standards for evaluating the nonobviousness of biotech patents are necessary for individual technologies in light of recent patent case law. A background of biotechnology is provided to help the reader understand how patents exploit the technology. The history of the nonobviousness requirement for patents is examined, focusing on developments within the last decade. Finally, the issue of patenting DNA inventions and the obviousness requirement are analyzed together. This analysis concludes that creating special standards for specific types of technology is neither reasonable nor necessary in patent law.

2. THE LEGAL DOCTRINE OF OBVIOUSNESS

   1. Obviousness Generally

      The Patent Act's nonobviousness requirement states that an inventor cannot receive a patent for an invention if the subject matter, as a whole, would have been obvious at the time of the invention to a person having ordinary skill in the art to which said subject matter pertains. (8) The defining Supreme Court case, Graham v. John Deere Co., (9) further developed the statutory rule by establishing a four-part test for obviousness. (10) The test requires the courts to 1) determine the scope and content of the prior art, 2) ascertain the differences between the claimed invention and the prior art, 3) resolve the level of ordinary skill in the pertinent art, and 4) consider secondary factors of nonobviousness, including commercial success and long-felt need in the art. (11) According to 35 U.S.C. [section]103(a), when the Patent and Trademark Office (PTO) declares something as obvious, it is saying that even if the invention were novel, (12) the invention would have been obvious to a person of ordinary skill in the art to which the subject matter pertains at the time the invention was made. (13) Section 103 (14) restricts patentability beyond novelty and utility, and excludes inventions that would have been obvious to someone skilled in the art. (15) This section asks the ultimate question of patentability: "whether an invention is a big enough technical advance to merit the award of a patent." (16)

      A patent application is presumed patentable if it is properly filed with the PTO. (17) If the patent application is rejected due to obviousness, it must be accompanied by a detailed prima facie case of obviousness by the PTO. (18) Thus, the burden falls on the patent examiner to show obviousness and ultimately unpatentability. (19) Patent claims are properly rejected under [section] 103 (20) when the modification of a single reference or the combination of two or more prior art references would have been obvious to one of ordinary skill in the art, leading to the invention of the claimed subject matter. (21)

      A prima facie case of obviousness exists when three basic criteria are met. First, there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings. Second, there must be a reasonable expectation of success; and third the prior reference (or combined references) must teach or suggest all of the claim limitations. (22)

      The suggestions or teachings to make the claimed invention and the reasonable expectation of success must both be found in the prior art. (23) The aid of hindsight is not allowed when evaluating the obviousness of an applicant's disclosure. (24) Courts have routinely applied the doctrine of structural similarity, as an alternative to the suggestion test, in chemical inventions. (25) The Federal Circuit, in the holding of In re Dillon, (26) restated that structural similarity between the claimed invention and prior art, proved by combining references or otherwise, where the prior art provides suggestion or motivation to make the claimed chemical compositions, creates a prima facie case of obviousness. (27) The burden then falls on the applicant to rebut that prima facie case after structural similarity has been shown. (28) Structural similarity simply means that if the structure of a compound found in the prior art is found to have analogous functional groups or structural formulae to the claimed invention, then as a matter of law the compounds are structurally similar. (29) Under Dillon, (30) both the starting and resulting materials in an analogous process are relevant, but not dispositive, in determining the obviousness of the process. (31)

   2. Section 103(b) Obviousness

      Courts and practitioners have recognized for several years that the nonobviousness requirement for chemical and biological inventions presents special issues that are difficult to address by simple application of [section] 103(a). (32) In the 1980s and early 1990s, a set of specialized cases emerged that addressed the unique issues arising from the rapidly developing field of biotechnology. (33)

      In 1995, Congress passed the Biotechnological Process Patents Act (BPPA), which amended [section] 103 to provide new standards of patentability for certain areas of biotechnology-related inventions. (34) Congress removed any remaining ambiguity surrounding patent protection for biotechnology process claims. (35) The stimulus for the BPPA stemmed from a special problem related to biotechnology processes and the inventions of biotechnology products. (36) Prior to the enactment of the BPPA, the courts were relying heavily on chemical process patent cases in their analysis of biotechnology process patents. (37)

      In the case of In re Durden (38) the Federal Circuit addressed the issue of whether the process for making a patentable compound was patentable itself. (39) The Federal Circuit, in Durden, affirmed that "a new process may still be obvious when considered 'as a whole', notwithstanding the specific starting material or resulting product, or both, is not found in the prior art." (40) Almost two-thirds of PTO process claims were rejected based on the decision of Durden. (41)

      The PTO regularly applied Durden (42) for the contention that the use of a nonobvious starting material in an otherwise obvious process does not necessarily result in a patentable, nonobvious process. (43) Overcoming this type of PTO rejection required a showing of "unexpected results," which generally translated into additional scientific experimentation and longer negotiations with the PTO. (44) The costs associated with further experimentation were prohibitive to applicants operating on limited budgets, such as universities and smaller firms. (45) Stretching small budgets was only one of the hurdles that smaller applicants had to overcome; the uncertainty was generally regarded as detrimental to the domestic biotechnology industry. (46)

      As a result of this amendment, the rules of [section] 103 (47) are now formally different for the biotechnology field than for all other fields of invention. (48) The BPPA gave inventors of biotechnology processes the option to make a "timely election" if certain specific conditions were met. (49) This election exempts the biotechnology process from the traditional [section] 103 (50) obviousness inquiry. (51)

2. GENERAL INTRODUCTION TO BIOTECHNOLOGY

   A large number of biotechnology patents claim inventions related to cellular biochemistry. (52) Cellular biochemistry is comprised of three main disciplines: deoxyribonucleic acid (DNA), (53) protein, (54) and cell biology. (55) DNA is nucleic acid that codes for the production of a cell's proteins. (56) Proteins have a direct influence over a cell's biochemistry. (57) Examples of a protein's influence include the catalytic activity of enzymes and antibody responses. (58) DNA is therefore an important tool for biotechnologists because of its ability, when engineered, to induce a cell's existing mechanisms and produce a specific protein of choice. This tool is also a challenge for the PTO because although the end products are usually new and novel, the process used to make them is relatively standardized.

   A gene is the segment of DNA involved in producing a polypeptide chain; (59) it includes regions before and after the coding region, (60) as well as the region of DNA on a chromosome whose sequence encodes a specific protein. (61) A codon, a triplet of three nucleic acids in the gene sequence, specifies amino acids. (62) The specific arrangement of this series of codons defines the amino acid sequence of the protein. (63)

   The resulting genetic code generates sixty-four possible triplets, sixty-one of which code for amino acids. (64) There are twenty different amino acids found in human proteins. (65) As a...