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The General Hospital Corporation v. Sienna Biopharmaceuticals

decided on May 4, 2018 by the Court of Appeals for the Federal Circuit

review by J. Matt Buchanan | published May 7, 2018 | updated May 7, 2018

tags: interference, written description, claim construction, ranges

In The General Hospital Corporation v. Sienna Biopharmaceuticals, the Court of Appeals for the Federal Circuit considered whether the USPTO Patent Trial and Appeal Board properly dismissed an interference for lack of standing by a patent applicant. In an interference between a patent application and U.S. Patent No. 8,821,941 [text], the Board found the claims of the application invalid for lack of sufficient written description under 35 U.S.C. 112. In construing a representative claim of the application, the Board reasoned that the term “about” means “within 10%,” which gave the claim term "about 6.6 × 10 11 particles per ml” a meaning that encompasses a range of 5.94 × 10 7.26 × 10 11 particles per ml. Finding no disclosure of a concentration within this range, the Board concluded that the representative claims lack written description support. On review, the Federal Circuit first considered the construction given the claim term "about." Noting that the application expressly defined the term to include a maximum value of "within 10%...of the stated value," the court concluded that the Board had properly construed the term. Armed with this construction and reviewing the underlying fact findings for substantial evidence, the court concluded that "substantial evidence supports the Board’s findings that none of the disclosed values in the ’575 application fall within 10% of the claimed value." Importantly, the specification disclosed a range of optical densities and several discrete values within that range. Citing Purdue Pharma v. Faulding, the court explained that "the disclosure of a broad range of values does not by itself provide written description support for a particular value within that range.” As a result, the court affirmed the Board's determination that the representative vlaims were unpatentable for lack of sufficient written description.

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Notes

claim construction

Claim term 'about' includes maximum variability included in a list of acceptable variabilities in specification

The specification of the application includes a listing of acceptable variabilities in its definition of the term 'about':

"About can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about."

In its de novo review of the Board's claim construction, the Federal Circuit noted this explicit definition and its maximum value of 10%, ultimately concluding that the Board had properly construed the term.

The lesson on the term 'about' remains as before: absent other contributing factors, acceptable variability or variabilities defined in the specification will likely carry the day.

written description | ranges

Disclosure of a broad range of values does not, by itself, provide written description support for individual values within that range

Considering the disclosure of a range of values in the specification, the court considered whether an individual value that lies within that range has sufficient written description support based solely on the disclosure of the range of values.

Citing Purdue Pharma v. Faulding, the court explained that:

"the disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims.” (emphasis added; internal quotations omitted)

written description | ranges

Disclosure of a range that minimally overlaps with a claimed range does not provide written description support for the claimed range

Desperately seeking basis for written description support, the patent applicant pointed to boilerplate language in the specification indicating that “[u]nless otherwise clear from context, all numerical values provided herein are modified by the term about.” Using this modifier, the applicant argued, the disclosed range overlapped with the claimed range, providing the required support.

Without commenting on the propriety of using boilerplate modifier language as a basis for written description support, the court instead focused on the "minimal overlap" of the disclosed range, as modified by the boilerplate language, and the claimed range:

"Even if we accept GHC’s argument that the specification may be read to convert each disclosed value into a range with 10% variation, GHC’s argument still fails, as a disclosed range that minimally overlaps with the claimed range does not provide written description support for the claimed range." (emphasis added)

The claimed values at issue arose in an interference context, so the desire for specific written description support surely only arose after the applicant learned of the claims of the potentially interfering patent. This situation, of course, will disappear as interferences die. There is a valuable drafting lesson in the court's decision, though-claimed ranges should be fully contained within the ranges explicitly defined within the specification. Don't rely on overlap or on an expansion of the disclosed range via a modifier term, such as 'about'.