GREGORY M. SLEET, District Judge.
The court having considered the submissions of the parties and having heard oral argument on the matter—IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of U.S. Patent No. 6,194,000 ("the '000 Patent"):
'000 Patent, col. 1 ll. 20-30. Despite failing to provide the court with a clear proposal, the defendant seeks a construction incorporating these specific physiological elements: temporal summation of C-fibre-mediated responses of dorsal horn nociceptive neurons.
The whole of the intrinsic evidence, however, does not support such a narrow interpretation. Indeed, even the above-quoted passage supports the court's ultimate construction. The final clause—"this phenomenon, increased output to a constant input, is known as wind-up"—is an effective definition of wind-up. After going through a complex, lengthy description of the physiology at play, the patentee elected to include a more simplified description in the form of an appositive to describe the "phenomenon" of wind-up: "increased output to a constant input."
See Apposition, MERRIAM-WEBSTER: DICTIONARY & THESAURUS, http://www.merriam-webster.com/dictionary/apposition (last visited July 9, 2015) ("an arrangement of words in which a noun or noun phrase is followed by another noun or noun phrase that refers to the same thing" (emphasis added)). Subsequent disclosures explain what the patentee meant by this: "These neural mechanisms may be expressed physically as hyperalgesia (increased pain sensation) and allodynia (pain arising from a stimulus that is not normally painful)." Id. col. 1 ll. 34-37. Thus, it is the painful expression of the underlying neural mechanisms that constitutes wind-up.
The prosecution history supports this view. In overcoming an indefiniteness rejection, the applicant stated:
(D.I. 60 at JA0159.) The Examiner accepted this explanation and in the Notice of Allowance concluded:
(Id. at JA0207 (emphasis added).) Again, it is the manifestation, or expression, of the nerve response that causes pain. This pain is called wind-up.
Both prosecution statements refer to wind-up as an "exaggerated pain response to a stimulus which normally would not be painful"—allodynia. But the patent specification makes clear that hyperalgesia—a more generalized increased pain sensation—also falls under the umbrella of wind-up. '000 Patent, col. 1 ll. 34-37. Thus, a definition simply requiring an exaggerated pain response—regardless of whether the input is normally painful—adequately captures the patent's teaching.
'000 Patent, claim 1. "Claim construction is a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee covered by the claims, for use in the determination of infringement. It is not an obligatory exercise in redundancy." U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). The plaintiffs appear to oppose construction not because it would improperly narrow the scope of the claims but, rather, because it is redundant—it restates what is already understood by the plain language. (D.I. 69 at 43-44.) The court, however, agrees with the defendant that the construction does indeed clarify an ambiguity in the claims. Specifically, the construction makes clear that the amounts "sufficient" to diminish or abolish wind-up are not merely theoretically sufficient. The immediate and sustained release forms are present in sufficient amounts to diminish wind-up in the subject actually receiving the treatment. Thus, the court is comfortable erring on the side of redundancy, as opposed to risking confusion at a later stage of litigation.
The specification is consistent with the view that immediate release forms of the NMDA receptor antagonist are not altered to extend or delay release. "A suitable immediate release (IR) form of the NMDA receptor antagonist may simply be particles of the antagonist or particles of the antagonist admixed with [various different components]." Id. col. 3 ll. 30-45. The patent does not teach that the combination of the active ingredient with these different components—even insoluble components—affects the release profile. But it does describe other functions: "A core used herein the description contains the active ingredient and other carriers and excipients, fillers, stablising agents, binders, core seeds or colorants." Id. col. 3 ll. 61-63. Moreover, the patent teaches that coatings can be used on immediate release cores but only "for aesthetic, handling, or stability purposes." Id. col. 6 ll. 11-13. Thus, there is nothing in the intrinsic record to suggest a different understanding of "immediate" should be applied—it means without delay and/or extension.
The plaintiffs' contention that constructions in the form of negative limitations—such as that proposed by the defendant—are disfavored or face a more exacting standard is a misunderstanding of Federal Circuit case law. See Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1322 (Fed. Cir. 2003).
The plaintiffs argue that the sustained release form releases the active ingredient over a longer period than that of the immediate release form. This relative construction—dependent entirely on immediate release—is simply not how the specification treats the claim term.
In particular, the defendant emphasizes the claims' use of the plural "amounts" rather than a single "amount" capable of diminishing or abolishing wind-up. See, e.g., '000 Patent, claim 1. The claim drafters perhaps could have framed the claims to require a single unified amount capable of treating wind-up. But the usage of "amounts" does not automatically require a different understanding. The combination of the immediate release form and the sustained release form will indeed result in two "amounts" of active ingredient, even if only the combined total is relevant. Thus, the plaintiffs' understanding is not an improper revision of the claims.
Moreover, "[c]laim language must be viewed in light of the specification, which is `the single best guide to the meaning of a disputed term.'" Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364 (Fed. Cir. 2014) (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005)). The specification always refers to the combined amount(s) as having the therapeutic effect, rather than the individual amount of each. "We have found that a particularly effective composition for the administration of an NMDA receptor antagonist to diminish or abolish wind up is one providing both immediate release of an NMDA receptor antagonist and controlled or sustained release of an NMDA receptor antagonist." Id. col. 1 ll. 52-56 (emphasis added); see also id. col. 5 ll. 6-10 ("The IR [intermediate release] and SR [sustained release] forms of the NMDA receptor antagonist are then combined into a single dosage such that the amount of NMDA receptor antagonist in the composition of the invention is in the range of about 1-5000 mg typically."). Never does the patent teach that each form is present in a sufficient amount to treat wind-up on its own. The court adjusts the construction to mirror the original claim language as closely as possible but largely adopts the plaintiffs' reasoning.