General Hospital Corp. v. Sienna Biopharmaceuticals, Inc. (Fed. Cir. 2018)

By Kevin E. Noonan --

The application of the written description requirement under 35 U.S.C. § 112(a) with regard to disclosed ranges is not always entirely straightforward or intuitively obvious, and this can particularly be the case when the question is involved with another notoriously arcane species of patent law, interferences.  (Interference practice was abolished, to the joy of many, with passage of the Leahy-Smith America Invents Act in 2012.)  Whether claims designated as corresponding to a count in an interference satisfy the written description requirement is a threshold issue which can lead to the interference being dismissed without the Patent Trial and Appeal Board (PTAB) rendering a decision on which claimant has proper priority, as well as finding said claims invalid.  Such was the decision against an applicant who had provoked an interference against claims of a granted patent, in General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., where the Federal Circuit in a precedential decision took the opportunity to reiterate the proper application of this requirement to the claims at issue and overturn the Patent Office's decision to terminate the interference.

The appeal arose over interference proceedings provoked by GHS between its U.S. Application No. 13/789,575 and Sienna's U.S. Patent No. 8,821,941.  The PTAB dismissed the interference on the grounds that GHC's claims failed to satisfy the written description requirement under 35 U.S.C. § 112(a) under § 41.202(a).  The technology at issue involved hair removal using nanoparticles to damage hair follicles.  The interference was declared on the basis of claim 1 of the '941 patent as the only count:

1.  A method of localizing thermal damage to a hair follicle, comprising: applying a composition to a skin surface, wherein said composition comprises a plurality of unassembled plasmonic nanoparticles, wherein the unassembled plasmonic nanoparticles comprise a conductive metal portion, wherein the conductive metal portion comprises at least one of gold or silver, wherein the unassembled plasmonic nanoparticles have a size in a range of 10 nm to 300 nm, wherein the unassembled plasmonic nanoparticles comprise a coating that coats the conductive metal portion, wherein said coating facilitates selective removal from the skin surface; wherein the coating comprises at least one of silica or polyethylene glycol (PEG), wherein 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; distributing the composition from the skin surface to the hair follicle to target the hair follicle; selectively removing the composition from the skin surface, while leaving the composition localized within the hair follicle; and irradiating the composition with an infrared light source thereby inducing a plurality of surface plasmons in said unassembled plasmonic nanoparticles, wherein the induction of the surface plasmons generates thermal damage to the hair follicle for at least one of hair removal or hair growth reduction.

(the limitation relevant to the issues before the Court is italicized).  Among the claims of Sienna's application corresponding to the count is claim 65:

65.  A method of localizing thermal damage to a hair follicle, comprising:
    applying a composition to a skin surface
    wherein said composition comprises a plurality of unassembled plasmonic nanoparticles,
    wherein the unassembled plasmonic nanoparticles comprise a conductive metal portion,
    wherein the conductive metal portion comprised gold,
    wherein the unassembled plasmonic nanoparticles have a diameter of about 150 nm,
    wherein the unassembled plasmonic nanoparticles comprise a coating that coats the conductive metal portion, wherein said coating facilitates selective removal from the skin surface,
    wherein the coating comprises polyethylene glycol (PEG),
    wherein the unassembled plasmonic nanoparticles have a concentration of about 6.6 x 10¹¹ particles per ml of the composition, wherein said concentration is sufficient to, after exposure to irradiation, induce thermal damage in the hair follicle;
    distributing the composition from the skin surface to the hair follicle to target the hair follicle;
    selectively removing the composition from the skin surface, while leaving the composition localized within the hair follicle; and
    irradiating the composition with an infrared light source thereby inducing a plurality of surface plasmons in said unassembled plasmonic nanoparticles,
    wherein the induction of the surface plasmons generated thermal damage to the hair follicle for at least one of hair removal or hair growth reduction.

(as with Sienna's claim, the limitation relevant to the issues before the Court is italicized).

The Board construed the word "about" in GHC's claims to mean "within 10%" of the value recited, equivalent to between 5.94 x 10¹¹ and 7.26 x 10¹¹ particles per mL of the composition, under which construction Sienna argued the claims failed to satisfy the written description requirement.  The specification of GHC's '575 application defined nanoparticle concentration with regard to optical density rather than in particles per mL.  Under the conversion coefficient proffered by Sienna's expert and accepted by the Board, there was no disclosure in GHC's '575 application of nanoparticle concentrations between 5.94 x 10¹¹ and 7.26 x 10¹¹ particles per mL of the composition.  Hence, the Board found  GHC's claims corresponding to the count to be unpatentable for failure to satisfy the written description requirement.

GHC also moved the Board for leave to add a new claim that would fall within the scope of the count in the interference.  The Board denied this motion because GHC failed to show that there was an interference-in-fact between the claims, and for failing to provide evidence that this claim was patentable.

The Federal Circuit vacated the Board's decision to terminate the interference in a decision by Judge Moore, joined by Judges Reyna and Taranto.  With regard to its written description decision, the Court affirmed the Board's construction of the term "about," reviewing claim construction de novo and the factual question of whether GHC's claims satisfied the written description requirement for substantial evidence.  In applying the written description requirement, the panel noted that GHC's claims-in-interference were not original claims (and thus, albeit unspoken, recognized that these claims were not entitled to the presumption that original claims get that they satisfy the written description requirement).  Converting GHC's disclosure into nanoparticles per mL the Board found that GHC's specification disclosed species having "4.10 x 10¹¹, 4.46 x 10¹¹, 7.77 x 10¹¹, 8.44 x 10¹¹, 9.32 x 10¹¹, 22 x 10¹¹, and 24 x 10¹¹ [nano]particles per ml."  Citing Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000), the panel noted that "[t]he 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.'"  In this case, the panel stated that GHC's specification disclosed a minimum concentration of 1 x 10¹¹ nanoparticles per mL and no maximum concentration other than "some value greater than 9.31 x 10¹¹ nanoparticles per ml" (with, as set forth above, some specific values even greater than that).  This is not enough to satisfy the written description requirement, however, because (again citing 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.'"  And even though there was "minimal overlap[]" between the range claimed in Sienna's claims and the range disclosed in GHC's specification this also was not enough, the panel citing  analogous facts in Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995), in support of its conclusion.

The Board erred however, according to the Federal Circuit, by denying GHC's motion to add a claim corresponding to the count.  This decision was arbitrary and capricious because the Board "did not engage in a substantive analysis of the claim's patentability or identify any particular ground on which GHC failed to establish patentability."  Pursuant to the Board's Standing Order (SO) governing interferences, the panel held that GHC had made the required certifications that its new claim was patentable.  The Board did not identify any inconsistency from the prosecution history upon which to base its unpatentability determination to the contrary, as required by the SO.  The Court also found error in the Board's finding regarding there being no interference-in-fact, based on the principle that "[w]here 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," citing Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1368 (Fed. Cir. 2012); In re Applied Materials, Inc., 692 F.2d 1289, 1295 (Fed. Cir. 2012); and In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003).  "It is not disputed that the values in the proposed claim fall within the ranges in claim 1 of the '941 patent.  Under the circumstances of this case, GHC has put forth sufficient evidence to establish proposed claim 74 would have been rendered obvious by claim 1 of the '941 patent," the panel concluded.  Thus the matter was remanded to the Board for continued interference proceedings, depending on whether the panel can find a basis for deciding that the new claim is patentable to GHC.

General Hospital Corp. v. Sienna Biopharmaceuticals, Inc. (Fed. Cir. 2018)
Panel: Circuit Judges Moore, Reyna, and Taranto
Opinion by Circuit Judge Moore

Comments

[Paul F. Morgan]

Not dead yet. There were at least 31 Pending Interferences as of 3/17, and there are still quite a few pending pre-AIA applications that could trigger a few more when they issue. Note also the special AIA transitional provision for interferences.

[Kevin E. Noonan]

Correct but certainly a dying breed