Gen. Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 2017-1012

Decision Date04 May 2018
Docket Number2017-1012
Citation888 F.3d 1368
Parties The GENERAL HOSPITAL CORPORATION, Appellant v. SIENNA BIOPHARMACEUTICALS, INC., Appellee
CourtU.S. Court of Appeals — Federal Circuit

Philippe Bennett, Alston & Bird LLP, New York, NY, argued for appellant. Also represented by Walter Scott; Aoife Butler, Chicago, IL; Peter Carl Lauro, Brian Landry, Saul Ewing Arnstein & Lehr LLP, Boston, MA.

Brenton R. Babcock, Knobbe, Martens, Olson & Bear, LLP, Irvine, CA, argued for appellee. Also represented by Edward M. Cannon.

Before Moore, Reyna, and Taranto, Circuit Judges.

Moore, Circuit Judge.

General Hospital Corp. ("GHC") appeals the Patent Trial and Appeal Board's dismissal of an interference determining it lacked standing because claims of U.S. Patent Application No. 13/789,575 lacked sufficient written description under § 112 of the Patent Act. It further appeals the Board's denial of its contingent motion to add a new claim. We vacate the Board's termination of the interference and remand for further proceedings.

BACKGROUND

The claims at issue relate to methods of removing hair using nanoparticles to damage hair follicles. GHC is the named applicant on the '575 application, and Sienna Biopharmaceuticals, Inc. ("Sienna") owns U.S. Patent No. 8,821,941. On October 8, 2015, at GHC's suggestion, the Board declared an interference. The Board identified claim 1 of the '941 patent as the sole count. Claim 1 is directed to a method of localizing thermal damage to a hair follicle by applying a composition comprising a plurality of unassembled plasmonic nanoparticles to a skin surface. Relevant to this appeal, claim 1 requires "the unassembled plasmonic nanoparticles have a concentration of 109 to 1023 particles per ml of the composition, wherein said concentration is sufficient to, after exposure to irradiation, induce thermal damage in the hair follicle."

The Board identified claims 65–67 of the '575 application and claims 1–20 of the '941 patent as corresponding to that count. Claim 65 is representative of the '575 claims. Like claim 1, it is directed to a method of localizing thermal damage to a hair follicle by applying a composition comprising a plurality of unassembled plasmonic nanoparticles to a skin surface. In claim 65, "the unassembled plasmonic nanoparticles have a concentration of about 6.6 × 1011 particles per ml of the composition." The Board construed "about" as it appears in claim 65 to mean "within 10%." Therefore, "about 6.6 × 1011 particles per ml" encompasses of a range of at most from 5.94 × 1011 to 7.26 × 1011 particles per ml.

Sienna moved for a determination that claims of the '575 application were unpatentable for failure to meet the written description requirement. The disclosure in the '575 application describes formulations by reference to optical density (OD) rather than particles per ml. The parties disputed the proper extinction coefficient to be used in converting optical density to concentration in particles per ml. The Board accepted an extinction coefficient of 4.2, crediting the testimony of Sienna's expert Dr. Tao over the testimony of GHC's expert Dr. Dmochowski. Applying this coefficient, the Board found no concentrations disclosed in the '575 disclosure were between 5.94 × 1011 and 7.26 × 1011 particles per ml. The Board, therefore, found claims 65–67 lack written description support and are unpatentable under § 112.

GHC moved to add new claim 74 expressly limiting the nanoparticles to have "an Optical Density of 250 O.D. when measured at a wavelength of about 810 nm." The Board denied this motion, determining that GHC did not show interference-in-fact with Sienna claim 1, or correspondence to Count 1, and failed to provide supporting evidence that this claim was patentable.

GHC appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A).

DISCUSSION
I

Sufficiency of written description is a question of fact, reviewed for substantial evidence. Inphi Corp. v. Netlist, Inc. , 805 F.3d 1350, 1354 (Fed. Cir. 2015). In determining whether the written description requirement is met, we consider "whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).

As a preliminary matter, the parties dispute the proper construction of the claim term "about." "We review the Board's claim construction de novo except for subsidiary fact findings, which we review for substantial evidence." Perfect Surgical Techniques, Inc. v. Olympus Am., Inc. , 841 F.3d 1004, 1012 (Fed. Cir. 2016). Here, the Board properly construed "about" to mean "within 10%." The '575 application defines "about," giving a broadest value of 10%:

Unless otherwise specifically stated or obvious from context, as used herein, the term "about" is understood as within a normal tolerance in the art, for example within 2 standard deviations of the mean. 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.

Although the specification and prosecution history of the '941 patent do not expressly define "about," the Board considered Dr. Tao's testimony that a range of 10% is consistent with the use of the word "about" in the '941 specification. None of the intrinsic or extrinsic evidence cited by GHC supports GHC's construction that "about" includes ± 20% variation. Moreover, GHC waived its argument that the broadest reasonable interpretation of "about" was ± 20%. In the interference, GHC only contested Sienna's proposed construction by generally denying that the broadest reasonable interpretation was "within 10%." J.A. 812. GHC did not present an alternative construction or explain why it disagreed with Sienna's proposed construction. Although GHC's expert Dr. Dmochowski stated in a declaration that a skilled artisan would have considered a 20% variation to be acceptable, the Board expressly stated that it would not consider this testimony because GHC did not rely on it or argue Dr. Tao's 10% variation was incorrect. We conclude that the Board properly determined that the claim limitation "about 6.6 × 1011 particles per ml" encompasses of a range of at most from 5.94 × 1011 to 7.26 × 1011 particles per ml.

Given this claim construction, substantial evidence supports the Board's findings that none of the disclosed values in the '575 application fall within 10% of the claimed value. Claims 65–67 of the '575 application, which include the "about 6.6 × 1011 particles per ml" limitation, are not original claims. The '575 application broadly discloses that "the composition comprises plasmonic particles that have an optical density of at least about 1 O.D." J.A. 3164. GHC has identified seven specific compositions in the '575 application, which it argues have optical densities of 132, 144, 250, 275, 300, 715, and 780. When converted to particles per ml, these optical densities give values of 4.10 × 1011, 4.46 × 1011, 7.77 × 1011, 8.44 × 1011, 9.31 × 1011, 22 × 1011, and 24 × 1011 particles per ml.

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." Purdue Pharma L.P. v. Faulding Inc. , 230 F.3d 1320, 1323 (Fed. Cir. 2000). In Purdue Pharma , we affirmed a district court finding that a claim requiring a pharmacokinetic concentration ratio (Cmax/C24) above 2 was not supported by sufficient written description where the specification (1) included examples of ratios above and below 2; (2) did not emphasize the Cmax/C24 ratio as an aspect of the invention; and (3) "disclose[d] a multitude of pharmacokinetic parameters, with no blaze marks directing the skilled artisan to the Cmax/C24 ratio or what that ratio should exceed." Id. at 1326.

Here, the specification discloses a range of optical densities and several discrete values within that range. The specification broadly states that in one embodiment the particles have an optical density of at least "about 1 O.D.," J.A. 3164, which GHC argued corresponds to less than 1 × 1011 particles per ml. The specification does not expressly identify a maximum concentration, and GHC did not argue any upper limit to the range disclosed other than "some value greater than 9.31 × 1011." J.A. 804. Several of the discrete values provided in the specification are even higher than that. As we stated in Purdue Pharma , "one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention." Purdue , 230 F.3d at 1326. The disclosure of a range of concentrations from less than 1 × 1011 particles per ml to some unidentified maximum, does not provide written description support for the claimed concentration of "about 6.6 × 1011 particles per ml," nor does the disclosure of particular discrete values within that range, none of which are the claimed value.

While GHC argues the written description requirement is met because when a 10% variability is applied to both the claimed value and one of the disclosed values, the ranges overlap, this argument is...

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