Go to MPEP - Table of Contents
2141 35 U.S.C. 103; the Graham Factual Inquiries - 2100 Patentability
2141 35 U.S.C. 103; the Graham Factual Inquiries
35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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 said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
(b)
(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if-
(A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and
(B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.
(2) A patent issued on a process under paragraph (1)-
(A) shall also contain the claims to the composition of matter used in or made by that process, or
(B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.
(3) For purposes of paragraph (1), the term "biotechnological process" means-
(A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to-
(i) express an exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or
(iii) express a specific physiological characteristic not naturally associated with said organism;
(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and
(C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).
(c) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person.
STANDARD OF PATENTABILITY TO BE APPLIED IN OBVIOUSNESS REJECTIONS
Patent examiners carry the responsibility of making sure that the standard of patentability enunciated by the Supreme Court and by the Congress is applied in each and every case. The Supreme Court in Graham v. John Deere, 383 U.S. 1, 148 USPQ 459 (1966), stated:
Under § 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquires may have relevancy. . .
This in not to say, however, that there will not be difficulties in applying the nonobviousness test. What is obvious is not a question upon which there is likely to be uniformity of thought in every given factual context. The difficulties, however, are comparable to those encountered daily by the courts in such frames of reference as negligence and scienter, and should be amenable to a case-by-case development. We believe that strict observance of the requirements laid down here will result in that uniformity and definitiveness which Congress called for in the 1952 Act.
Office policy is to follow Graham v. John Deere Co. in the consideration and determination of obviousness under 35 U.S.C. 103. As quoted above, the four factual inquires enunciated therein as a background for determining obviousness are as follows:
(A) Determining the scope and contents of the prior art;
(B) Ascertaining the differences between the prior art and the claims in issue;
(C) Resolving the level of ordinary skill in the pertinent art; and
(D) Evaluating evidence of secondary considerations.
The Supreme Court reaffirmed and relied upon the Graham three pronged test in its consideration and determination of obviousness in the fact situations presented in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh'g denied, 426 U.S. 955 (1976) and Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969). In each case, the Court discussed whether the claimed combinations produced a "new or different function" and a "synergistic result," but it clearly decided whether the claimed inventions were nonobviousness on the basis of the three-way test in Graham. Nowhere in its decisions in these cases does the Court state that the "new or different function" and "synergistic result" tests supersede a finding of nonobvious or obviousness under the Graham test.
Accordingly, examiners should apply the test for patentability under 35 U.S.C. 103 set forth in Graham. See below for a detailed discussion of each of the Graham factual inquiries. It should be noted that the Supreme Court's application of the Graham test to the fact circumstances in Ag Pro was somewhat stringent, as it was in Black Rock. Note Republic Industries, Inc. v. Schlage Lock Co., 592 F.2d 963, 200 USPQ 769 (7th Cir. 1979). The Court of Appeals for the Federal Circuit stated in Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540, 218 USPQ 871, 880 (Fed. Cir. 1983) that
A requirement for "synergism" or a "synergistic effect" is nowhere found in the statute, 35 U.S.C. When present, for example in a chemical case, synergism may point toward nonobviousness, but its absence has no place in evaluating the evidence on obviousness. The more objective findings suggested in Graham, supra, are drawn from the language of the statute and are fully adequate guides for evaluating the evidence relating to compliance with 35 U.S.C. § 103. Bowser Inc. v. United States, 388 F. 2d 346, 156 USPQ 406 (Ct. Cl. 1967).
BASIC CONSIDERATIONS WHICH APPLY TO OBVIOUSNESS REJECTIONS
When applying 35 U.S.C. 103, the following tenets of patent law must be adhered to:
(A) The claimed invention must be considered as a whole;
(B) The references must be considered as a whole and must suggest the desirability and thus the obviousness of making the combination;
(C) The references must be viewed without the benefit of impermissible hindsight vision afforded by the claimed invention; and
(D) Reasonable expectation of success is the standard with which obviousness is determined.
Hodosh v. Block Drug Co., Inc., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir. 1986).
OBJECTIVE EVIDENCE MUST BE CONSIDERED
Objective evidence or secondary considerations such as unexpected results, commercial success, long-felt need, failure of others, copying by others, licensing, and skepticism of experts are relevant to the issue of obviousness and must be considered in every case in which they are present. When evidence of any of these secondary considerations is submitted, the examiner must evaluate the evidence. The weight to be accorded to the evidence depends on the individual factual circumstances of each case. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 231 USPQ 81 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987). The ultimate determination on patentability is made on the entire record. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992).
See MPEP § 716- § 716.06 for a discussion of objective evidence and its role in the final legal determination of whether a claimed invention would have been obvious under 35 U.S.C. 103.
Go to MPEP - Table of Contents