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Skinmedica, Inc v. Histogen Inc.; Histogen Aesthetics LLC; Gail K. Naughton

May 24, 2011

SKINMEDICA, INC.,
PLAINTIFF,
v.
HISTOGEN INC.; HISTOGEN AESTHETICS LLC; GAIL K. NAUGHTON, DEFENDANTS.



The opinion of the court was delivered by: Honorable Janis L. Sammartino United States District Judge

ORDER: CONSTRUING DISPUTED CLAIM TERMS OF UNITED STATES PATENT NOS. 6,372,494 AND 7,118,746 AND RELATED COUNTERCLAIMS

Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), the Court conducted a hearing on February 15 and 16, 2011 regarding the construction of disputed claim terms in United States Patent Nos. 6,372,494 (the '494 patent) and 7,118,746 (the '746 patent). Attorneys Stephen Swinton and Alexander Long appeared on behalf of Plaintiff SkinMedica, Inc. Plaintiff's expert, Dr. Daniel Salomon, also testified at the hearing. Attorneys Randall Kay, Lisa Haile, and Erin Gibson appeared on behalf of Defendants Histogen Inc., Histogen Aesthetics LLC, and Gail K. Naughton (collectively, Histogen). Upon careful consideration of the papers and counsel's oral arguments, the Court issues the following Order construing the disputed claim terms of the patents at issue in this case.

BACKGROUND

On January 22, 2009, SkinMedica filed this action alleging, inter alia, infringement of the '494 and '746 patents. (Doc. No. 1.) SkinMedica's operative complaint asserts claims for patent infringement, misappropriation of trade secrets, unfair competition, breach of contract, and imposition of constructive trust. (Doc. No. 31.) Histogen has filed counterclaims for a declaration of patent non-infringement and unfair competition. (Doc. No. 35.) And each side asserts various affirmative defenses to the other's claims. (Id.; Doc. No. 40.)

Generally, the '494 and '746 patents "describe and encompass 'novel conditioned cell culture medium compositions' and 'uses for these novel compositions.'" (Doc. No. 44 (SkinMedica's Claim Construction Brief (CCB)), at 9 (citing '494 Patent col.4 ll.40--44); accord Doc. No. 48 (Histogen's Responsive CCB), at 3 ("[T]he claims of the Asserted Patents are directed toward methods of making conditioned medium using a three-dimensional culture system . . . .").) "Cell culture medium is the liquid solution used to 'culture,' or, 'grow' cells in vitro, and typically includes various raw materials-e.g., amino acids, vitamins, sugars, etc.-that the cells need to grow and expand in number." (SkinMedica's CCB 9 (citing '494 Patent col.1 ll.21--26).) "Once the culture medium is incubated with cells, it becomes a 'spent' or 'conditioned' medium." (Id. (citing '494 Patent col.1 ll.30--32).) "The '494 and '746 patents are specifically directed to conditioned medium derived from cells cultured in three-dimensions." (Id.) Cells cultured in three dimensions "express an extracellular matrix of proteins, thus forming a living tissue." (Id. (citing '494 Patent col.6 ll.54--56).) Further, cells cultured in three dimensions secrete growth factors and other proteins in ratios higher than cells cultured in two-dimensional monolayers. (Id. (citing '494 Patent col.5 ll.1--4, col.6 ll.9--17).) Thus, conditioned medium derived from cells grown in three dimensions is superior to conditioned medium derived from cells grown in two dimensions. (See id.)

The independent claims of the '494 patent recite a method of making a composition, comprising "culturing fibroblast cells in three-dimensions . . . so that a conditioned medium is formed," "removing the conditioned medium from the cultured cells," and "combining the conditioned medium with a pharmaceutically acceptable carrier." '494 Patent col.32 ll.10--19, 33--49. The single independent claim of the '746 patent recites "[a] method of reducing deleterious effects to keratinocytes," comprising "administering to the keratinocytes a composition comprising conditioned cell medium that has previously supported the growth of mesenchymal cells cultured in three-dimensions on a non-living support . . . thereby reducing intracellular oxidation in the keratinocytes." '746 Patent col.40 ll.7--18.

LEGAL STANDARD

The Court construes the scope and meaning of disputed patent claims as a matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 388--90 (1996). Words of a claim are "generally given their ordinary and customary meaning." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). This is the meaning the term would have to a person of ordinary skill in the art as of the effective filing date of the patent application. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). Because the inquiry into the meaning of claim terms is an objective one, the court looks to publicly available sources to show what a person would have understood the claim language to mean. Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004). Those sources include the claims, the specification, the prosecution history, and relevant extrinsic evidence. Id.

Claim construction begins with an analysis of the words of the claims themselves. See Scanner Techs. Corp. v. ICOS Vision Sys. Corp., 365 F.3d 1299, 1303 (Fed. Cir. 2004). In examining the claims, "the context in which a term is used can be highly instructive." Phillips, 415 F.3d at 1314. Moreover, "[o]ther claims of the patent in question, both asserted and unasserted can . . . be valuable sources of enlightenment as to the meaning of a claim term." Id. "Because claim terms are normally used consistently throughout the patent, the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Conversely, under the doctrine of claim differentiation, "'different words or phrases used in separate claims are presumed to indicate that the claims have different meanings and scope.'" Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1369 (Fed. Cir. 2007) (quoting Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971--72 (Fed. Cir. 1999)).

"Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Phillips, 415 F.3d at 1313. "Usually, [the specification] is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics, 90 F.3d at 1582; accord Phillips, 415 F.3d at 1317. The specification acts as a dictionary when it expressly or implicitly defines terms used in the claims. Vitronics, 90 F.3d at 1582. In doing so, the patentee may define a claim term in a manner inconsistent with its ordinary meaning. Metabolite Labs., Inc. v. Lab. Corp. of Am., 370 F.3d 1354, 1360 (Fed. Cir. 2004).

Patent claims ordinarily should be construed to encompass the preferred embodiments described in the specification, for "[a] claim construction that excludes a preferred embodiment . . . 'is rarely, if ever correct.'" SanDisk Corp. v. Memorex Prods., Inc., 415 F.3d 1278, 1285 (Fed. Cir. 2005). However, a court should not import limitations from the specification into the claims, Phillips, 415 F.3d at 1323, absent a specific reference in the claims themselves, Reinshaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998).

The prosecution history may also inform claim construction. Vitronics, 90 F.3d at 1582. "Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent." Phillips, 415 F.3d at 1317. It can be useful to show "how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

"In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence." Vitronics, 90 F.3d at 1583. But this is not a rule of admissibility, nor does it "prohibit courts from examining extrinsic evidence, even where the patent document is itself clear." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999). The court is not "barred from considering any particular sources or required to analyze sources in any specific sequence, as long as those sources are not used to contradict claim meaning that is unambiguous in light of the intrinsic evidence." Phillips, 415 F.3d at 1324.

CONSTRUCTION

The '494 and '746 patents descend from the same application, and have similar specifications and claims. (See Histogen's Responsive CCB 3 ("The '746 patent is a continuation-in-part of the '494 patent . . . ."); '746 Patent, at [63].) Accordingly, the Court construes the patents together.

The parties dispute the meaning of over a dozen claim terms. (See generally Doc. No. 33 (Joint Claim Construction Chart).) However, because several of the disputed terms "are either identical or substantially the same across the two patents," the parties agree that "the Court need only address eight collective arguments."*fn1 (SkinMedica's CCB 11; see Histogen's Responsive CCB 8--23 (adopting SkinMedica's grouping of terms).) The Court addresses each argument in turn.

1. Dr. Salomon's Testimony

At the threshold, the Court notes that it admitted Dr. Salomon's testimony as to the meaning of the disputed claim terms over Defendants' objection. (See Doc. Nos. 146--147 (CC Hr'g Tr.), at 82--151; Doc. No. 140 (Order Overruling Defendants' Objections to Extrinsic Evidence).) Upon exhaustive review, however, the Court concludes that the intrinsic evidence of the disputed terms' meanings generally provides a sufficient basis from which to construe the terms. Accordingly, the Court declines to rely on Dr. Salomon's testimony except as specifically stated herein, where it is consistent with the intrinsic patent record. See Vitronics, 90 F.3d at 1584.

2. "culturing . . . cells in three-dimensions"

Claim language SkinMedica's proposed Histogen's proposed construction construction*fn2

"culturing fibroblast cells in Plain meaning, or "growing "growing fibroblast cells on a three-dimensions" fibroblast cells in three structure forming a porous dimensions" framework (as opposed to monolayers or beads) wherein the cells proliferate both on the surface of and into the pores of the framework, forming a three dimensional tissue"

"cultured in three- Plain meaning or "grown in "growing cells on a structure dimensions" three dimensions" forming a porous framework (as opposed to monolayers or beads) wherein the cells proliferate both on the surface of and into the pores of the framework, forming a three dimensional tissue" "culturing mesenchymal cells Plain meaning or "growing "growing mesenchymal cells in three-dimensions" mesenchymal cells in three on a structure forming a dimensions" porous framework (as opposed to monolayers or beads) wherein the cells proliferate both on the surface of and into the pores of the framework, forming a three dimensional tissue"

The term "culturing . . . cells in three-dimensions" is repeated in substantially the same form in claims 1 and 8 of the '494 patent, and claims 1 and 11 of the '746 patent. (Histogen's Responsive CCB 8.) "[T]he parties have agreed that this term has a common meaning across its various incarnations . . . ." (SkinMedica's CCB 12.) "The only difference is the scope of the tissue specific cells that are part of the culture . . . ." (Histogen's Responsive CCB 8.)

The parties agree that "'culturing' means 'growing' and that the terms 'three-dimensions' or 'three-dimensional' require no further elaboration or clarification." (SkinMedica's CCB 12.) Accordingly, the Court need only determine whether the inventors further limited the invention to specific embodiments described in the specification. (See, e.g., Doc. No. 43 (Histogen's CCB), at 6 ("[T]he claim construction issue for the Court's determination is what conditions, including structures, are encompassed by 'culturing . . . in three-dimensions' within the meaning of the [asserted] patent[s].").)

SkinMedica contends that "culturing . . . cells in three-dimensions" "has a plain meaning to a person of ordinary skill in the art taken in light of the patent record" (SkinMedica's CCB 12 (citing Doc. No. 44-1 (Salomon Decl. ISO SkinMedica's CCB) ¶ 16)) and encompasses any method of culturing cells known in the art (id. (citing '494 Patent col.9 l.66 to col.10 l.2)). According to SkinMedica, "culturing in three-dimensions" "does not involve any special structural or other functional features." (Id.)

Histogen seeks to narrow SkinMedica's proposed construction in two respects. The Court addresses each in turn.

A. "(as opposed to monolayers or beads)"

First, Histogen contends that the inventors acted as their own lexicographers by "clearly and unambiguously defining 'culturing . . . in three-dimensions'" to exclude "culturing 'in monolayer' or on 'beads (i.e. in two-dimensions).'" (Histogen's CCB 6; accord id. at 21--22.) According to Histogen, "[t]hroughout the specification[s], the . . . inventors consistently distinguish their invention of culturing cells in three-dimensions from growing cells in monolayer or on beads, which was explicitly carved out from their claimed invention . . . ." (Histogen's CCB 7; accord id. at 22.) "In every instance in which culturing cells on beads is described in the Asserted Patents' specifications, it its defined as culturing in two-dimensions and beads are distinguished from three-dimensional culture." (Histogen's Responsive CCB 9 (emphasis in original).)

The specifications contain four relevant references to beads:

(1) "Cell lines grown as a monolayer or on beads, as opposed to cells grown in three-dimensions, lack the cell--cell and cell--matrix interactions characteristic of whole tissue in vivo," '494 Patent col.1 ll.37--40 (emphasis added);

(2) "Conventional conditioned cell culture medium, medium cultured by cell-lines grown as a monolayer or on beads, is usually discarded or occasionally used in culture manipulations such as reducing cell densities," '494 Patent col.1 ll.44--47 (emphasis added);

(3) "The cells are cultured in monolayer, beads (i.e., two-dimensions) or, preferably, in three-dimensions," '494 Patent col.7 ll.28--29 (emphasis added); and

(4) "The cells may be cultured in any manner known in the art including in monolayer, beads[,] or in three-dimensions and by any means (i.e., culture dish, roller bottle, a continuous flow system, etc.)," '494 Patent col.9 l.66 to col.10 l.2.*fn3 From these references, Histogen concludes that the inventors defined culturing on beads as culturing in two dimensions. (Histogen's CCB 7--8; Histogen's Responsive CCB 10 ("The many phrases distinguishing and defining culturing on beads as culturing in two-dimensions 'as opposed to' culturing in three-dimensions were added to the '494 and '746 patent specifications, and should be given meaning.").) Accordingly, "[t]he intrinsic record compels a construction of 'culturing . . . in three dimensions' to require culturing . . . cells using a framework or structure other than . . . using beads." (Histogen's CCB 8.)

SkinMedica responds that nothing in the patent record "evidences a clear and unmistakable intention to narrow the plain language of 'culturing . . . cells in three-dimensions' to exclude the use of microcarrier beads in three dimensions." (SkinMedica's Responsive CCB 3.) SkinMedica points out that, during the '494 patent's prosecution, the inventors overcame a rejection as anticipated over prior art "by clarifying that the invention was directed to a conditioned medium derived from a cell culture grown in three-dimensions, as opposed to the monolayer (i.e., two-dimensional) cell culture" disclosed in the prior art. (Id. (citing id. Ex. 24, at 25).) But aside from "specifying that the cell culture used to condition the medium of the claimed invention must be three-dimensional," the inventors did not describe any "particular conditions, including structures" as either mandatory or outside the scope of the invention. (Id. at 4.)

Further, although SkinMedica concedes that the specification distinguishes "cells . . . cultured in three-dimensions" from cells grown in two dimensions "using beads," SkinMedica contends that "this is not the same as defining 'beads' used as the three-dimensional framework to be a two-dimensional cell culture." (Id. at 5 (emphasis in original).) According to SkinMedica, Histogen confuses "the composition of the framework with the dimensionality of the cell culture." (Id. (emphasis in original).) Thus, to adopt Histogen's proposed construction would contradict the broad definition of "three-dimensional framework" in the patents' specifications*fn4 and the understanding of persons of ordinary skill in the art. (Id. (citing, inter alia, Salomon Decl. ISO SkinMedica's CCB ¶¶ 11--12).)

Finally, SkinMedica contends that its proposed construction, which would include the use of beads, comports with the intrinsic patent record. (Id.) Specifically, Cell & Tissue Culture: Laboratory Procedures, which SkinMedica contends is incorporated into the patents by reference in its entirety, see '494 Patent col.7 ll.50--52; id. ...


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