Chapter §9.11 Biotechnological Processes: §103(b) (2006) [Pre-America Invents Act of 2011]

• Jurisdiction: United States

§9.11 Biotechnological Processes: §103(b) (2006) [Pre-America Invents Act of 2011]

The rarely invoked §103(b) of the pre-AIA Patent Act created a statutory shield that prevented the USPTO from rejecting certain biotechnology process claims for obviousness. If a patent applicant presented a claim to a biotechnological process as defined in §103(b)(3)(2006), and the process used or resulted in a composition of matter that was both novel and nonobvious, the applicant could elect to proceed under §103(b). If the applicant timely made such election, the USPTO would consider the biotechnological process nonobvious.⁸⁶⁴

Congress enacted subsection (b) of §103 in 1995,⁸⁶⁵ seeking to legislatively resolve a perceived conflict between the Federal Circuit decisions In re Durden⁸⁶⁶ and In re Pleuddemann.⁸⁶⁷ The Federal Circuit decided In re Ochiai a few weeks thereafter, resolving the conflict through judicial decision.⁸⁶⁸ Thus §103(b) was quickly rendered largely unnecessary and moot. The USPTO's official guidance to its examiners stated that "[i]n view of the Federal Circuit's decisions in Ochiai and Brouwer, an applicant's need to rely upon 35 U.S.C. 103(b) should be rare."⁸⁶⁹

§9.10 STANDARDS OF REVIEW FOR §103

The America Invents Act of 2011 repealed 35 U.S.C. §103(b) (2006) as no longer needed.⁸⁷⁰

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Notes:

^[864] See USPTO, Manual of Patent Examining Procedure §706.02(n) (8th ed. 2008).

^[865] Biotechnology Process Patent Act, Pub. L. No. 104-41, §1(3) (1995) (codified at 35 U.S.C. §§103, 282 (2000)).

^[866] In re Durden, 763 F.2d 1406 (Fed. Cir. 1985).

^[867] In re Pleuddemann, 910 F.2d 823 (Fed. Cir. 1990).

^[868] In re Ochiai, 71 F.3d 1565 (Fed. Cir. 1995). The Ochiai decision, together with In re Brouwer, 77 F.3d 422 (Fed. Cir. 1996), addressed the general issue of whether an otherwise conventional process could be patented if the process claims were limited to making or using a nonobvious product.

^[869] USPTO, Manual of Patent Examining Procedure §706.02(n) (8th ed. 2008).

^[870] See Leahy-Smith America Invents Act, Pub. L. No. 112-29, §3(c), 125 Stat. 284, 287 (Sept. 16, 2011) (amending 35 U.S.C. §103 (2006) so as to delete subsections 103(b) (2006) and 103(c) (2006)); 157 Cong. Rec. S1371 (Mar. 8, 2011) (statement of Sen. Kyl that "in both the present bill and earlier versions, former subsection (b) of section 103 has been dropped, since it has already been subsumed in caselaw."), available at https://www.congress.gov/112/crec/2011/03/08/CREC-2011-03-08-pt...