General Hospital Corporation v. Sienna Biopharmaceuticals
Opinion
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
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 × 10 11 particles per ml of the composition." The Board construed "about" as it appears in claim 65 to mean "within 10%." Therefore, "about 6.6 × 10 11 particles per ml" encompasses of a range of at most from 5.94 × 10 11 to 7.26 × 10 11 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. *1371 Dmochowski. Applying this coefficient, the Board found no concentrations disclosed in the '575 disclosure were between 5.94 × 10 11 and 7.26 × 10 11 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
DISCUSSION
I
Sufficiency of written description is a question of fact, reviewed for substantial evidence.
Inphi Corp. v. Netlist, Inc.
,
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.
,
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 × 10 11 particles per ml" encompasses of a range of at most from 5.94 × 10 11 to 7.26 × 10 11 particles per ml.
Given this claim construction, substantial evidence supports the Board's *1372 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 × 10 11 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 × 10 11 , 4.46 × 10 11 , 7.77 × 10 11 , 8.44 × 10 11 , 9.31 × 10 11 , 22 × 10 11 , and 24 × 10 11 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.
,
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 × 10
11
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 × 10
11
." 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
,
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 unavailing. The specification discloses an optical density of 250 OD, which GHC argues corresponds to 7.77 × 10
11
particles per ml. GHC argues a 10% variability should be applied to this value, generating a range from 6.99 × 10
11
to 8.55 × 10
11
particles per ml. Because this range overlaps with the claimed range of "about 6.6 × 10
11
particles per ml" or from 5.94 × 10
11
to 7.26 × 10
11
particles per ml, GHC argues the written description requirement is met. This argument relies on language in the specification that states "[u]nless otherwise clear from context, all numerical values provided herein are modified by the term about." J.A. 92. 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,
*1373
as a disclosed range that minimally overlaps with the claimed range does not provide written description support for the claimed range. In
Eiselstein v. Frank
,
II
The Board also denied GHC's contingent motion to amend to add new claim 74, determining that GHC failed to show claim 74 was patentable and failed to meet its burden of showing the proposed claim interferes with any of Sienna's claims. We review the Board's denial of a motion to amend to determine if it is arbitrary or capricious.
Veritas Techs. LLC v. Veeam Software Corp.
,
The Board's determination that GHC failed to meet its burden to show that the claim 74 is patentable was arbitrary and capricious. GHC certified it was not aware of any reason why the claim was not patentable. The Board stated GHC failed to direct it to evidence supporting the certification, but it did not engage in a substantive analysis of the claim's patentability or identify any particular ground on which GHC failed to establish patentability. The Board has adopted a Standing Order for conducting interferences, which in accordance with Board practice, was entered into the docket.
See
In re Sullivan
,
The Board's determination that GHC had not established claim 74 interferes with any of Sienna's claims was not in accordance with our controlling precedent. Neither the parties nor the Board dispute that proposed claim 74 covers a particular species of the genus set forth in the '941 claim. Nevertheless, the Board determined GHC had not met its burden because it had not provided evidence that a skilled artisan "would have considered it obvious to have chosen the narrow range of nanoparticle diameter and optical density recited in its proposed claim 74."
Where a prior art patent discloses a range of values, showing a claimed value falls within that range meets a party's burden of establishing the narrower claim would have been obvious where there is no reason to think the result would be unpredictable.
See, e.g.
,
*1374
Galderma Labs., L.P. v. Tolmar, Inc.
,
CONCLUSION
For the foregoing reasons, we affirm the Board's finding that claims 65-67 are unpatentable for lack of sufficient written description. We vacate the Board's denial of GHC's contingent motion to add a new claim and remand for further proceedings.
AFFIRMED IN PART AND VACATED AND REMANDED IN PART
COSTS
No costs.
Reference
- Full Case Name
- The GENERAL HOSPITAL CORPORATION, Appellant v. SIENNA BIOPHARMACEUTICALS, INC., Appellee
- Cited By
- 13 cases
- Status
- Published