Stanford and the Chinese University of Hong Kong (CHUK) have been locked in a battle over patents covering DNA sequencing methods that allow identification of abnormal fetal chromosomes. CHUK had convinced the PTAB that Stanford's later-added claims to random DNA sequencing were invalid as failing the possession aspect of the written description requirement, since Standford's application was allegedly directed only to targeted DNA sequencing as the invention (even though it mentioned random sequencing as well).
The possession test is a somewhat amorphous test that tends to be used to invalidate patents more in the chemical and biological arts, but recently is being championed by the USPTO as a way to reject almost any application. The Federal Circuit summarized the rule, quoting precedent, as depending on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed. More specifically, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.
The Federal Circuit specifically pointed out that the specification can still meet the requirements of the statute even though it can be open to several options:
Substantial evidence supports a finding that the specification satisfies the written description requirement when “the essence of the original disclosure” conveys the necessary information—“regardless of how it” conveys such information, and even when the disclosure’s “words [a]re open to different interpretation[s].” In re Wright, 866 F.2d 422, 424–25 (Fed. Cir. 1989)
While even this extra explanation does not eliminate the ambiguity in the test, the Federal Circuit found a clear error, among several other errors, in how the PTAB analyzed the possession issue. Specifically, the PTAB reasoned that while Stanford's application had all of the parts of the later added claims, the specification never put them together to indicate that the inventor recognized them as an invention. From the PTAB's decision:
Though the Quake inventors may have possessed parts of such a method, including massively parallel sequencing, randomly fragmenting DNA, and aligning sequences to genomic sequences, the facts do not indicate that those of ordinary skill in the art would have understood the inventors had put these pieces together into a complete method of sequencing random DNA fragments and identifying the sequenced fragments to determine aneuploidy.
The PTAB based this conclusion on a finding that Stanford's specification does not preclude targeted massively parallel sequencing, reasoning therefore that those of skill in the art could have considered the specification to be directed to targeted sequencing, as opposed to random sequencing.
The Federal Circuit made clear that the written description test should focus on whether the claims are supported, not whether unclaimed elements are eliminated:
The Board frames its finding in terms of an erroneous premise: the Board’s task was to determine whether the ’018 patent’s written description discloses random MPS sequencing, as recited by the later-added claims, not whether the description does not preclude targeted MPS sequencing.
Hopefully the USPTO will help provide Examiners more guidance on how to properly analyze the written description requirement so that it is not used as a catch-all rejection applicable to any case as desired.