Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_09-cv-00122/USCOURTS-casd-3_09-cv-00122-2/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:145 Patent Infringement

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UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

SKINMEDICA, INC.,

Plaintiff,

CASE NO. 09-CV-122 JLS (NLS)

ORDER: GRANTING

DEFENDANTS’ MOTION FOR

PARTIAL SUMMARY

JUDGMENT OF

NONINFRINGEMENT

(ECF No. 153)

vs.

HISTOGEN INC.; HISTOGEN

AESTHETICS LLC; GAIL K. NAUGHTON,

Defendants. ____________________________________

AND RELATED COUNTERCLAIMS

Presently before the Court is Defendant’s motion for partial summary judgment of

noninfringement. (ECF No. 153.) Plaintiff opposes the motion. Having considered the parties’

arguments and the law, the Court GRANTS Defendant’s motion for partial summary judgment.

BACKGROUND

I. Factual History

Plaintiff SkinMedica, Inc. (“SkinMedica”) brought this patent infringement action against

Defendants Histogen, Inc., Histogen Aesthetics LLC, and Gail K. Naughton (collectively,

“Histogen”). SkinMedica and Histogen both develop and sell products for treating dermatologic

conditions and diseases affecting skin appearance. The patents in suit are United States Patent

Nos. 6,372, 494 (the ‘494 patent) and 7,188,746 (the ‘746 patent). 

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SkinMedica is a privately held company that sells its products primarily to dermatologists

and plastic surgeons. Among SkinMedica’s products is its TNS® (for Tissue Nutrient System)

line of anti-aging products. The main ingredient in the TNS line of products is NouriCel®. 

NouriCel was originally developed by Advanced Tissue Science, Inc. (“ATS”). In 2002, ATS

filed for bankruptcy. In 2003, through the ATS bankruptcy proceedings, SkinMedica claims to

have acquired all of the assets, “including the trade secrets and know-how,” related to NouriCel

through an Asset Purchase Agreement (“APA”). SkinMedica contends that the APA included

both the ‘494 and the ‘746 patents asserted in this lawsuit. 

Defendant Gail Naughton was the co-founder, President, Chief Operating Officer, and

Chief Scientific Officer at ATS. She was also the lead named inventor on the ‘494 and ‘746

patents. Naughton left ATS shortly after it filed for bankruptcy, and is now the Chief Executive

Officer and Chairman of the Board of Directors for Histogen.

During her tenure at ATS, Naughton and her colleagues experimented with NouriCel,

ultimately discovering that NouriCel could possibly stimulate hair growth. By September 2002,

Naughton presented a confidential report on NouriCel’s hair growth potential to ATS’s Scientific

Advisory Board (“the SAB Report”). In her official capacity as Vice Chairman of ATS, Naughton

claims to have been authorized to discuss the contents of the SAB Report with outside parties,

including a former ATS employee no longer under a confidentiality agreement, and competing

pharmaceutical companies.

Beginning in 2004, Naughton and Histogen began filing patent applications for

“conditioned medium” research similar to the NouriCel research Naughton performed at ATS. 

However, as of January 2009, the U.S. Patent and Trademark Office and the European Patent

Office had rejected all of these claims in light of prior art.

II. The Patents in Suit

Generally, the ‘494 and ‘746 patents describe and encompass “novel conditioned cell

culture medium compositions” derived from cells cultured in three-dimensions. See ‘494 Patent

col. 4 ll.40-44; ‘746 Patent col.40 ll.7-18. 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,

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vitamins, sugars, etc.—that the cells need to grow and expand in number.” ‘494 Patent col.1

ll.21–26. “Once the culture medium is incubated with cells, it becomes a ‘spent’ or ‘conditioned’

medium.” ‘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. Cells cultured in three dimensions “express an extracellular

matrix of proteins, thus forming a living tissue.” ‘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. ‘494 Patent col.5 ll.1-4, col.6 ll.9-17. Thus, conditioned medium

derived from cells grown in three dimensions, such as NouriCel, is superior to conditioned

medium derived from cells grown in two dimensions. 

III. The Accused Products

In October 2008, SkinMedica became aware that Histogen planned to launch a line of skin

care products based on a conditioned medium called ReGenicaTM that sounded similar to

SkinMedica’s NouriCel technology. These products include the ReGenica Facial Rejuvenation

Complex, Regenica Advanced Rejuvenation Day Repair, and the ReGenica Advanced

Rejuvenation Overnight Repair products, in addition to other unknown products directed for use as

a promoter for hair growth (collectively, “the accused products”). 

The parties seem to agree on the method steps Histogen uses for cell culturing, although

they disagree as to which of these steps is relevant to the issue of infringement. Histogen states it

manufactures the accused products “by growing cells in monolayer in smooth surface roller bottles

on microcarrier beads.” (Def.’s Mem. ISO Motion 1, ECF No. 153.) These microcarriers are

“microscopic beads” to which cells are attached and then later “mixed in vessels to a fluidized

condition to maximize, and provide control of, mass transport characteristics.” (Baumgartner

Decl. ISO Def.’s Motion, Ex. 10.) Known as “bioreactor vessels,” these vessels contains

microcarrier beads and are kept continuously stirring as cells grow on the microcarrier beads. 

(Baumgartner Decl. ¶ 12.) Eventually, the cells secrete “sticky” extracellular matrix (“ECM”)

proteins that coat the beads and the surrounding surfaces. (Pl.’s Opp’n 8, ECF No. 171 (quoting

Aug. 25, 2009 Naughton Dep., at 120:5-8.)) The sticky nature of this extracellular matrix leads to

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the formation of “clumps” or aggregates of beads. (Id.) After aggregates of beads begin to form,

the cells continue to produce ECM, which forms bridges between beads, creating a threedimensional structure. (Id.) Thus, SkinMedica summarizes that “cells which start out ‘on’ the

beads in two dimensions then migrate into the newly forming ECM scaffold and continue to

proliferate, thereby creating a three-dimensional cell culture.” (Id. (quoting Jun. 2, 2009 Naughton

Dep., at 65:25-66:6, 71:17-24.)) Histogen’s illustration of this process for investors shows the

formation of the three-dimensional ECM scaffold between beads, from which ReGenica is

obtained. 

(Pl.’s Opp’n 8 (citing Histogen Doc. H0007, Ex. G.)) 

IV. Relevant Procedural History

On January 22, 2009, SkinMedica filed the instant lawsuit against Naughton, Histogen, and

Histogen Aesthetics alleging, inter alia, infringement of the ‘494 and ‘746 patents. (ECF 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. (ECF

No. 31.) Histogen has filed counterclaims for a declaration of patent non-infringement and unfair

competition. (ECF No. 35.) And each side asserts various affirmative defenses to the other’s

claims. (Id.; ECF No. 40.)

On May 24, 2011, the Court issued an order construing the disputed claim terms of the

‘494 and ‘746 patents. (Claim Construction Order (CCO), ECF No. 150.) Subsequently, 

Histogen filed the instant motion for partial summary judgment of noninfringement. (ECF No.

153.) SkinMedica filed an opposition, and Histogen replied. (ECF Nos. 171, 177.) SkinMedica

then filed an ex parte motion for leave to file a sur-reply to Histogen’s reply, and Histogen

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opposed. (ECF Nos. 185, 187.) On October 11, 2011, the Court denied SkinMedica’s motion for

leave to file a sur-reply. (ECF No. 189.) The Court held oral argument on November 4, 2011, and

took the matter under submission. 

LEGAL STANDARD

Federal Rule of Civil Procedure 56 permits a court to grant summary judgment where (1)

the moving party demonstrates the absence of a genuine issue of material fact and (2) entitlement

to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). "Material,"

for purposes of Rule 56, means that the fact, under governing substantive law, could affect the

outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Freeman v.

Arpaio, 125 F.3d 732, 735 (9th Cir. 1997). For a dispute to be "genuine," a reasonable jury must

be able to return a verdict for the nonmoving party. Anderson, 477 U.S. at 248.

The initial burden of establishing the absence of a genuine issue of material fact falls on the

moving party. Celotex, 477 U.S. at 323. The movant can carry his burden in two ways: (1) by

presenting evidence that negates an essential element of the nonmoving party's case; or (2) by

demonstrating that the nonmoving party "failed to make a sufficient showing on an essential

element of her case with respect to which she has the burden of proof." Id. at 322–23. "Disputes

over irrelevant or unnecessary facts will not preclude a grant of summary judgment." T.W. Elec.

Serv., Inc. v. Pac. Elec. Contractors Ass'n, 809 F.2d 626, 630 (9th Cir. 1987).

Once the moving party establishes the absence of genuine issues of material fact, the

burden shifts to the nonmoving party to set forth facts showing that a genuine issue of disputed

fact remains. Celotex, 477 U.S. at 324. The nonmoving party cannot oppose a properly supported

summary judgment motion by "rest[ing] on mere allegations or denials of his pleadings." 

Anderson, 477 U.S. at 256. When ruling on a summary judgment motion, the court must view all

inferences drawn from the underlying facts in the light most favorable to the nonmoving party. 

Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).

In the context of patent litigation, “[i]nfringement is assessed by comparing the accused

device to the claims; the accused device infringes if it incorporates every limitation of a claim,

either literally or under the doctrine of equivalents. If, however, even one claim limitation is

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missing or not met, there is no literal infringement.” MicroStrategy, Inc. v. Bus. Objects, S.A., 429

F.3d 1344, 1352 (Fed. Cir. 2005). Where there is a factual dispute as to whether the allegedly

infringing device includes a claim limitation, summary judgment is not appropriate. Int’l Rectifier

Corp. v. IXYS Corp., 361 F.3d 1363, 1375 (Fed. Cir. 2004). However, where parties do not

dispute any fact regarding the accused product, but instead disagree over interpretations of the

court’s claim construction, summary judgment is appropriate. Gen. Mills, Inc. v. Hunt-Wesson,

Inc., 103 F.3d 978, 983 (Fed. Cir. 1997). 

ANALYSIS

Infringement analysis involves a two-step process: first, the court must determine the

meaning of disputed claim terms, and second, the court must compare the accused device to the

claims as construed. Wavetronix v. EIS Electronic Integrated Sys., 573 F.3d 1343, 1354 (Fed. Cir.

2009) (citing Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995)). Here,

the Court has already determined the meaning of the disputed claim term in its May 24 Claim

Construction Order. Thus, the single task before the Court for the resolution of the present motion

is to compare the accused products to the claims as construed. The parties contest the proper

interpretation of the Court’s construction of a single claim element, “culturing . . . cells in threedimensions,” which 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. The parties also contest the correct comparison of the

accused products with this disputed claim element. If the accused products do not incorporate this

claim limitation as construed, the products do not infringe. Thus, the Court will address in turn the

interpretation of the claim construction and a comparison of the accused products to the disputed

claim element as construed.

Histogen argues that the Court’s construction of the disputed claim element excludes the

growth of cells using beads. (Def.’s Mem. ISO Motion 2.) Histogen claims the cell culture

method steps for the accused products involve growing cells “in monolayer . . . or by using

microcarrier beads,” which was excluded by the Court’s construction of that claim element. (Id. at

2.) Thus, its process for manufacturing the accused products does not infringe this necessary

claim element of both the ‘494 and ‘746 patents. (Id. at 1.) Because this claim limitation is

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missing from the accused products, Histogen argues summary judgment of noninfringement is

appropriate. 

SkinMedica counters that three-dimensional growth between beads is not excluded by the

Court’s claim construction, which excludes growing cells “on beads.” (Pl.’s Opp’n 1-2.)

According to SkinMedica, the accused products are derived from a three-dimensional cell culture

that eventually grows on ECM formed between beads, which infringes the disputed claim element. 

 Histogen opposes this interpretation, and also objects on the basis that this “ECM theory” was not

contained in SkinMedica’s Final Infringement Contentions, as required by the patent local rules of

the Southern District of California, as well as the Court’s scheduling order. (Def.’s Reply 2.) 

Both parties agree that Histogen’s process for manufacturing the accused devices involves

the use of beads. (Def.’s Mem. ISO Motion 1; Pl’s Opp’n 1.) The key question is whether the

Court construed the disputed claim element to exclude all types of growth using beads, or merely

the growth of cells on beads. The Court agrees with Histogen that the use of microcarrier beads

was excluded from the construction of “culturing . . . cells in three-dimensions,” and that as a

result the accused products do not infringe this claim element, rendering summary judgment of

noninfringement appropriate.

I. Claim Construction

The Court construed the term “culturing . . . cells in three-dimensions” to mean

“growing . . . cells in three dimensions (excluding growing . . . cells in monolayers or on

microcarrier beads).” (CCO 13.) The Court’s claim construction order specifically addresses the

use of beads at length in the context of construing this term, eventually deciding to exclude beads

from the disputed claim element based on the patent record. (CCO 6-11, 13.) 

SkinMedica argues that the claim construction order left open “the prospect that

Defendants may still infringe if they use beads in the formation of a ‘three-dimensional

framework’ on which a three-dimensional cell culture might subsist to any extent, and at any stage

of their cell culture process.” (Pl.’s Opp’n 1.) SkinMedica emphasizes that the claim construction

language only excludes two-dimensional cell growth “on beads.” (Pl.’s Opp’n 3.) SkinMedica

implores the Court to “carefully scrutinize the Defendants’ erroneous and deceptive argument that

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culturing cells in any way ‘using beads’ is equivalent to culturing cells ‘on beads.’” 

(Pl.’s Opp’n 4.) After carefully scrutinizing both parties’ arguments, the Court cannot agree with

SkinMedica. 

SkinMedica’s argument places too much emphasis on the importance of the single word

“on,” and overlooks the substance of the Court’s analysis in which it construes the disputed claim

element to exclude beads. Because this analysis is vital to properly interpreting the construction of

the disputed claim element, the Court briefly summarizes the claim construction’s reasoning

below. 

The Court arrived at the construction of the disputed claim element after examining the

patent record, which showed “that the inventors acted as their own lexicographers, defining

‘culturing . . . cells in three-dimensions’ away from its ordinary meaning. . . . By consistently

distinguishing culturing on beads from culturing in three dimensions, the inventors defined

‘culturing . . . cells in three dimensions’ by implication to exclude culturing on beads.” (CCO 9-

10.) The inventors did this “despite that culturing cells in three dimensions on beads was known

in the art at the time the patent was filed.” (Id. at 10.) Thus, it was based on the inventor’s own

exclusion of three-dimensional culturing on beads that the Court excluded beads from the claim. 

Crucially, the Court found that the inventor had excluded culturing on beads from the claimed

invention in spite of the fact that three-dimensional culturing on (or using) beads was already

known in the art at that time.

At the Markman hearing, SkinMedica attempted to avoid this result by incorporating into

the intrinsic patent record Cell & Tissue Culture: Laboratory Procedures, which describes “how

beads may be used to culture cells in three dimensions”:

A common occurrence in microcarrier culture is the formation of large microcarrier

aggregates in which the microcarriers are joined by cellular bridges. Microcarrier

aggregates made up of as many as 10 or more microcarriers are not uncommon. . . .

In certain cases, such as to promote bead-to-bead transfer of cells to bare

microcarriers, low agitation rates would be desirable during the culture growth

phase.

(emphasis added). A. DOYLE ET AL., CELL & TISSUE CULTURE: LABORATORY PROCEDURES 8D:2.7

(1996), available at SkinMedica’s CCB Ex. 7; see also (CCO 9.) Although SkinMedica argued

that Doyle et al.’s “discussion of beads as a three-dimensional culture method” was incorporated

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by reference and thus the use of beads comported with intrinsic patent record, the Court rejected

this argument. (CCO 10-11.) After examining the patent record, the Court held that “because

Doyle et al.’s discussion of beads as a three-dimensional culture method is not incorporated into

the patents by reference, the intrinsic patent record does not compel a broader construction of

‘culturing . . . cells in three-dimensions.’” (Id. at 11.) Even though three-dimensional growth of

cells using beads already existed at the time of the ‘494 and ‘746 patents, the patent record did not

disclose even a single instance of such methods. The Court explicitly stated in its analysis of the

disputed claim element that culturing cells in three dimensions was being construed “away from its

ordinary meaning” to exclude the use of beads and that, because the inventor “disclosed [not even]

a single reference to culturing cells in three dimensions using beads,” this method could not be

incorporated into the patent’s claim. (emphasis added) (CCO 9-10.) Thus, the Court’s analysis of

the disputed claim element makes clear that the patent record did not disclose three-dimensional

cell culturing using beads, which is why the Court excluded beads in the claim construction.

However, SkinMedica appears to ignore this analysis and argues that, because all of the

references in the patent specification equated the phrase “on beads” to a two-dimensional cell

culture method, the Court’s construction imports this limitation. (Pl.’s Opp’n 5.) SkinMedica is

correct in that the Court found, through an examination of the patent record, that the inventors had

defined “beads” as a two-dimensional culture method. (CCO 10.) As previously discussed, the

Court found the intrinsic record did not contain any reference to culturing cells in three dimensions

using beads, even though such methods existed in the prior art. However, SkinMedica attempts to

distort the significance of this fact. Although the inventor equated culturing “on beads” with

culturing in two dimensions, the Court did not. In fact, the Court explicitly rejected the inventor’s

definition as contrary to the prior art. In declining to incorporate the Doyle reference into the

intrinsic record, the Court made clear that even three-dimensional culture methods on beads were

excluded by the inventor. Thus, the Court finds that SkinMedica’s attempt to narrow the claim

construction based on the inventor’s equation of beads with a two-dimensional culture method is

unfounded and misleading. 

//

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In fact, there is no indication at all in the claim construction order that the Court’s use of

the preposition “on” as opposed to the preposition “between” or the gerund “using” carries the

meaning that SkinMedica seeks to have attached to it. To the contrary, the Court’s claim

construction analysis switches interchangeably between “on” and “using” throughout, without

attempting to differentiate the two words. This switching between “on” and “using” depends

sometimes on the word used in the patent record, and sometimes on nothing more than the Court’s

dictional preference. The Doyle reference, which the Court declined to incorporate into the

intrinsic patent record, does not emphasize the growth must be “on beads.” Instead, it describes

“the formation of large microcarrier aggregates in which the microcarriers are joined by cellular

bridges” and discusses “bead-to-bead transfer of cells to bare microcarriers.” (CCO 9-10.) It was

the inventor’s failure to disclose any references to culturing cells in three dimensions using beads,

not any distinction between whether the cells were growing on the beads or between the beads,

that dominated the Court’s analysis of the claim limitation. 

Nor does the Court’s rejection of Histogen’s proposed claim construction language indicate

that the word “on” leaves open the possibility of infringement by three-dimensional growth using

beads, as SkinMedica argues. (Pl.’s Opp’n 1.) For the claim “culturing . . . cells in threedimensions,” Histogen proposed the following construction: “growing . . . cells on a structure

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.” (CCO

6.) The Court divided its analysis of Histogen’s proposed construction into two parts. The Court

discussed first “as opposed to monolayers or beads,” and second “a structure forming a porous

framework . . . wherein the cells proliferate both on the surface of and into the pores of the

framework, forming a three dimensional tissue.” The Court agreed with Histogen’s proposed

construction as to the first part, excluding beads from the disputed claim element (CCO 9, 11), and

rejected Histogen’s proposed construction as to the second part, declining to limit the disputed

claim element to growth on mesh or porous frameworks (CCO 12-13). Because these two parts

were both elements of the same claim and were intertwined in Histogen’s proposed construction,

the Court necessarily could not adopt either party’s proposed construction in its entirety. However,

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in construing the disputed claim element, the Court did not state any important distinction between

Histogen’s proposed language, “as opposed to monolayers or beads,” and the language adopted in

the claim construction, “excluding growing . . . cells in monolayers or on microcarrier beads.” 

SkinMedica ignores that it was necessary to edit Histogen’s proposed language because the Court

rejected Histogen’s proposed (and intertwined) porous framework limitation. Instead of accepting

this logical and obvious explanation, SkinMedica argues that the Court suddenly attached

significant meaning to the word “on” in the language construing the disputed term, and that the use

of the word “on” was meant to import the important limitation that solely two-dimensional growth

on beads was excluded, without any explicit clarification of this meaning. The Court finds that

SkinMedica’s proposed distinction between “on” and “using” is simply not supported by the claim

construction analysis. 

Finally, SkinMedica asserts that the Court’s decision not to exclude beads from serving as

part of a “framework . . . formed into a three-dimensional structures,” which is a different, nondisputed claim element, somehow “embraces the presence of beads in the three-dimensional cell

structure – at least for the portions of the culture where cells are not growing ‘on’ the beads

themselves.” (Pl.’s Opp’n 5-6.) However, this argument erroneously implies that a broad

interpretation of one claim element should impact a different claim element. In order to infringe the

patents in question, the accused devices must incorporate every limitation of a claim. 

MicroStrategy, Inc. v. Bus. Objects, S.A., 429 F.3d 1344, 1352 (Fed. Cir. 2005.) That one element

of the claim incorporates the use of beads does not negate the explicit exclusion of beads by another

element of the claim. Nor does the Court’s decision not to constrain the disputed element to porous

frameworks, as Histogen suggested, embrace the presence of beads, which are specifically excluded

by the claim construction language. Thus, the Court finds that SkinMedia’s attempts to import

convenient language from other claim elements into the disputed claim element fail. 

In sum, the Court rejects SkinMedica’s argument that the Court’s construction of the

disputed claim element excludes only two-dimensional growth on beads, not three-dimensional

growth using beads. SkinMedica cannot reargue the Court’s construction of the disputed claim

element in opposing the instant motion. The Court finds that the disputed claim element as

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1

The Court notes that SkinMedica has not argued that the accused products infringe under the

doctrine of equivalents or any other theory of infringement other than direct infringment in opposition

to the present motion. (See Pl.’s Opp’n.) 

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construed, “excluding growing . . . cells in monolayers or on microcarrier beads,” is not limited to

two-dimensional culture methods on beads.

II. Infringement

Having resolved the proper interpretation of the construction of the disputed claim element,

the Court now turns to the issue of whether Histogen’s accused products infringe this element.1

The Court finds that they do not.

There is no dispute that Histogen’s process for the accused products starts with cells

growing on beads as part of the “seeding” process. At oral argument, both parties also admitted

that this process, which starts as one- or two-dimensional growth, evolves into a three-dimensional

growth phase in which the cells crawl off the beads and grow on three-dimensional ECM,

consistent with the Doyle reference. 

In spite of admitting, for the purposes of this motion, that its process for the accused

products involves three-dimensional cell growth between beads on ECM, Histogen argued for the

first time at oral argument that the Court need not consider any stages of the cell growth process

beyond the initial one- or two-dimensional growth stage on beads. Histogen apparently now

proposes the only relevant fact to the instant motion is the fact that the cells grow on beads initially. 

According to Histogen, what happens after (namely, three-dimensional growth between beads as

explained in the Doyle reference) is immaterial.

SkinMedica counters that the later stages of cell growth are vital to the issue currently

before the Court. Although Histogen’s method begins with cells growing in one- or twodimensions on beads, it evolves and changes until the cells are growing in three-dimensions on

ECM formed between beads. “While Defendants may begin their conditioned media production

process by growing cells ‘on beads,’ that process creates a three-dimensional framework comprised

of extracellular matrix (“ECM”) formed in the interstices between multiple beads that aggregate or

‘clump’ together while stirred in a solution of liquid media.” (Pl.’s Opp’n 1-2.) Thus, according to

SkinMedica, “Defendants not only grow cells ‘on beads’ but also within a three-dimensional

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The Court rejects Histogen’s argument that the Court should not consider SkinMedica’s

opposition because SkinMedica failed to present its “ECM theory” in its Final Infringement

Contentions. (Def.’s Reply 2.) The Court agrees that patent local rules require parties to state with

specificity the theories upon which they plan to rely early in the litigation. These rules are important

because they “require parties to crystallize their theories” so as to “prevent the ‘shifting sands’

approach to claim construction.” O2 Micro Int’l Ltd. v. Monolithic Power Sys., 467 F.3d 1355 (Fed.

Cir. 2006) (quoting Atmel Corp. v. Info. Storage Devices, Inc., 1998 WL 775115 at *2 (N.D. Cal.

1998)). However, here it is not clear that SkinMedica failed to adequately disclose its current

infringement theory. See, e.g., SkinMedica’s Final Infringement Contentions, Ex. A at 4 (“ReGenica

is produced by culturing cells in three dimensions using dextran microcarrier beads and extracellular

matrix formed between those beads.”) Histogen itself points out that SkinMedica’s current ECM

theory is similar to what it argued at the Markman hearing. (Def.’s Reply 7.) As a result, the Court

finds Histogen had adequate warning of the ECM theory presented in SkinMedica’s opposition and

will consider it in ruling on this motion. 

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extracellular matrix framework.” (emphasis in original) (Id. at 2.)2 It is this cell growth within the

three-dimensional ECM, which eventually grows between beads in the manufacture of the accused

products, that SkinMedica reasons infringes the disputed claim element.

The Court agrees with SkinMedica that the later stages of Histogen’s cell growth on the

ECM formed between beads is relevant to the issue of infringement, but ultimately finds that even

this later stage cannot not infringe the patents in suit because the disputed claim element is not

incorporated in the accused products. 

First, the Court finds that the claim element “growing . . . cells in three-dimensions” is not

limited to the initial “seeding” stage of growth. There is nothing in the claim construction order to

indicate such a limitation, and Histogen points to no facts or legal arguments to support its

contention that the Court should ignore the later stages of cell growth. Thus, the Court will

consider all stages of Histogen’s process for manufacturing the accused products which involve

“growing . . . cells.” 

However, even considering all stages of Histogen’s cell growth process, the Court finds

Histogen’s accused products do not infringe the disputed claim element. The parties agree that

Histogen’s process uses beads at all stages. Even when some of the cells are growing on ECM, this

ECM is formed on and around beads. All of SkinMedica’s arguments in opposition to partial

summary judgment of noninfringement rely upon its premise that the claim limitation “excluding

growing . . . cells in monolayers or on microcarrier beads” applies only to the two-dimensional

growth of cells on beads, and that the use of beads to grow cells in three dimensions is not

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excluded. However, as discussed above, the Court rejects these arguments. SkinMedica’s premise

is contrary to the patent history and contrary to the Court’s claim construction analysis. Thus,

Histogen’s cell growth process, which uses beads, cannot infringe the disputed claim element as

construed. 

CONCLUSION

For the foregoing reasons, the Court GRANTS Histogen’s motion for summary judgment of

noninfringement of both the ‘494 and the ‘746 patents. 

IT IS SO ORDERED.

DATED: November 21, 2011

Honorable Janis L. Sammartino

United States District Judge

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