The recent decision in Goeddel v. Sugano concerns an appeal from an interference proceeding. Although these types of cases may be a “dying breed” if patent reform goes through (as discussed in this PLI Patent Law Practice Center post), this case highlights written description requirement issues that are relevant outside of the interference context. Specifically, Goeddel underscores the differing standards of sufficiency when examining a patent application from the written description requirement perspective, versus viewing a patent application as a piece of prior art for non-obviousness determination against another patent application. The holding here would seem to imply that a prior patent application that can likely render a contested invention obvious and not patentable may nevertheless fail the written description requirement itself, and thus face a 35 U.S.C. § 112 rejection.
The scientific basis of this case can be summarized as follows. Mature Human Fibroblast Interferon (hFIF) comprises 166 amino acids, but is encoded in a native 187 amino acid precursor form that undergoes post translational cleavage of 21 amino acids in vivo. Both parties are interested in patenting the process of creating recombinant forms of mature hFIF. In essence, the contested species is the truncated DNA sequence corresponding to the 166 amino acid mature hFIF (mature form), rather than the full sequence corresponding to the 187 amino acid precursor (precursor form).
Sugano’s Japanese application disclosed the precursor form of hFIF, but did not describe the mature form, or the process of transforming the precursor to the mature form. The patent office and BPAI gave Sugano priority in his US application, relying on Sugano’s earlier Japanese application as evidence of constructive reduction to practice. The Federal Circuit reversed BPAI’s decision, and awarded priority to Goeddel based on Sugano’s failure to meet the written description requirement. In particular, the court found that Sugano’s original Japanese application does not sufficiently demonstrate constructive reduction to practice to satisfy the written description requirement of 35 U.S.C. § 112, first paragraph.
The Federal Circuit asked whether Sugano adequately conveyed to a person having ordinary skill in the art (PHOSITA) that he had in his possession the mature form, or the process of taking his disclosed precursor form to the undisclosed mature form. Sugano argued that it was “unnecessary to spell out every detail of the invention in the specification.” Judge Newman wrote that
[t]he question is not whether one skilled in this field of science might have been able to produce mature hFIF by building upon the teachings of the Japanese Application, but rather whether that application “convey[ed] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” [citation omitted]
In other words, the question is not whether the Japanese application would qualify as prior art in an obviousness determination under 35 U.S.C. § 103 against Goeddel, but whether the Japanese application fulfills the § 112 written description requirement that the inventor Sugano had the invention in his possession at the critical date. Essentially, BPAI asked the wrong question, holding that a PHOSITA “should have been able to envision” [emphasis added] the mature form from Sugano’s Japanese application.
The problem with Sugano’s “envision” argument is its inevitable tie to obviousness. Something likely can be envisioned because it is obvious. The written description requirement is not one concerned with obviousness. Rather, the written description requirement demands, as literally as possible, that the inventor convinces the world that he is indeed in full possession of the invention that he is claiming. Ironically, it appears that Sugano’s Japanese application disclosed sufficient information such that if the application is asserted as a piece of foreign prior art against Goeddel, it would render Goeddel’s invention obvious. As Patently-O concluded, Goeddel may have “won the battle only to lose the war.”
- Goeddel v. Sugano (Fed. Cir. 2010) (PDF)
- “Written Description: When Too Much is Not Enough” (PharmaPatents)
- “PHOSITA: Flogging a Dead Horse” (Patent Baristas)
- “Federal Circuit: Foreign Application Not Priority in Interference When it Only ‘Envisions’ Invention” (PLI Patent Law Practice Center)
- “CAFC: Disclosure That Merely Allows PHOSITA to ‘Envision’ the Claimed Invention Fails Written Description” (The 271 Patent Blog)
- “Goeddel v. Sugano (Fed Cir. 2010)” (Patent Docs)
- “Written Description: Description Must do more than Allow PHOSITA to ‘Envision’ the Claimed Invention” (Patently-O)
- Summary of Goeddel v. Sugano (Ryan Chirnomas of Westerman, Hattori, Daniels & Adrian, LLP) (PDF)