2147 Biotechnology Process Applications; Pre-AIA 35 U.S.C. 103(b) [R-01.2024]
[Editor Note: This MPEP section is not applicable to applications subject to examination under the first inventor to file (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et seq. to determine whether an application is subject to examination under the FITF provisions, and MPEP § 2150 et seq. for examination of applications subject to those provisions.]
Pre-AIA 35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.
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- (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).
- (A) a process of genetically altering or otherwise
inducing a single- or multi-celled organism to-
- (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-
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Pre-AIA 35 U.S.C. 103(b) is applicable to biotechnological processes only. Pre-AIA 35 U.S.C. 103(b) precludes a rejection of process claims which involve the use or making of certain nonobvious biotechnological compositions of matter under pre-AIA 35 U.S.C. 103(a). Only applications subject to pre-AIA 35 U.S.C. 102 are subject to pre-AIA 35 U.S.C. 103(b). See MPEP § 2159.
Pre-AIA 35 U.S.C. 103(b) requires that:
- (A) the biotechnological process and composition of matter be contained in either the same application or in separate applications having the same effective filing date;
- (B) both the biotechnological process and composition of matter be owned or subject to an assignment to the same person at the time the process was invented;
- (C) a patent issued on the process also contain the claims to the composition of matter used in or made by the process, or, if the process and composition of matter are in different patents, the patents expire on the same date;
- (D) the biotechnological process falls within the definition set forth in pre-AIA 35 U.S.C. 103(b); and
- (E) a timely election be made to proceed under the provisions of pre-AIA 35 U.S.C. 103(b).
An election to proceed under pre-AIA 35 U.S.C. 103(b) shall be made by way of petition under 37 CFR 1.182. The petition must establish that all the requirements set forth in pre-AIA 35 U.S.C. 103(b) have been satisfied.
An election will normally be considered timely if it is made no later than the earlier of either the payment of the issue fee or the filing of an appeal brief in an application which contains a composition of matter claim which has not been rejected under pre-AIA 35 U.S.C. 102 or 103(a).
In an application where at least one composition of matter claim has not been rejected under pre-AIA 35 U.S.C. 102 or 103(a), a pre-AIA 35 U.S.C. 103(b) election may be made by submitting the petition and an amendment requesting entry of process claims which correspond to the composition of matter claim.
For applications pending on or after November 1, 1995, in which the issue fee has been paid prior to March 26, 1996, the timeliness requirement for an election under pre-AIA 35 U.S.C. 103(b) will be considered satisfied if the conditions of 37 CFR 1.312(b) are met. However, if a patent is granted on an application entitled to the benefit of pre-AIA 35 U.S.C. 103(b) without an election having been made as a result of error, patentees may file a reissue application to permit consideration of process claims which qualify for pre-AIA 35 U.S.C. 103(b) treatment. See MPEP § 1412.02, subsection II.
See MPEP § 2116.01 for a discussion of the Federal Circuit’s decisions in In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995) and In re Brouwer, 77 F.3d 422, 37 USPQ2d 1663 (Fed. Cir. 1996) which address the general issue of whether an otherwise conventional process could be patented if it were limited to making or using a nonobvious product. In view of the Federal Circuit’s decisions in Ochiai and Brouwer, an applicant’s need to rely upon pre-AIA 35 U.S.C. 103(b) should be rare. See also 1184 OG 86 (Comm’r Pat. 1996). See 35 U.S.C. 282 for the effect of a determination of nonobviousness under pre-AIA 35 U.S.C. 103(b)(1) on the presumption of validity.
