Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_10-cv-01780/USCOURTS-azd-2_10-cv-01780-1/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 28:1338 Patent Infringement

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WO

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

Medicis Pharmaceutical Corporation, 

Plaintiff, 

vs.

Acella Pharmaceuticals Incorporated, 

Defendant. 

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No. CV 10-1780-PHX-JAT

ORDER

After holding a Markman hearing on February 23, 2011, the Court enters the

following claim construction Order. 

I. Background

Plaintiff Medicis Pharmaceutical Corporation (“Medicis”) owns, through assignment,

United States Letters Patent No. 7,776,355 (the “Patent”). The Patent claims a topical drug

delivery system comprised of a pad, a container, and a liquid composition that includes

dermatologically active ingredients. Medicis uses the Patent’s drug delivery system in

Medicis products, including its Triaz® Foaming Cloths. Triaz® Foaming Cloths deliver

benzoyl peroxide to the skin to treat acne. Triaz® Foaming Cloths are available in three

different strengths: 3%, 6%, and 9%. 

Defendant Acella Pharmaceuticals Inc. (“Acella”) sells benzoyl peroxide foaming

cloths in three different strengths: 3%, 6%, and 9%. Medicis believes the Acella foaming

cloths directly infringe the Patent. Medicis therefore filed this suit for patent infringement

Case 2:10-cv-01780-JAT Document 148 Filed 03/02/11 Page 1 of 20
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The Court ordered the parties to jointly submit a stipulated chart that lists all the

claim terms the parties wanted the Court to construe. (Doc. 132). The Court bases this Order

on the stipulated chart (Doc. 133) submitted by the parties in compliance with the Order at

Docket entry 132. 

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on August 19, 2010. 

The parties have asked the Court to construe four of the Patent’s claim terms.1

Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996), the Court

must construe the claims as a matter of law. The parties have filed briefs supporting their

proposed constructions of the claim terms. Having considered the arguments and evidence

presented in the parties’ briefs, exhibits, and at the Markman hearing, the Court construes the

disputed terms as follows. 

II. Legal Standard

Section 112 of the Patent Act provides that a patent specification “shall contain a

written description of the invention, and of the manner and process of making and using it

in such full, clear, concise, and exact terms as to enable any person skilled in the art to which

it pertains . . . to make and use the same . . .” 35 U.S.C. §112. The section further provides

that a specification “shall conclude with one or more claims particularly pointing out and

distinctly claiming the subject matter which the applicant regards as his invention.” Id. 

“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the

invention to which the patentee is entitled the right to exclude.’” Phillips v. AWH Corp., 415

F.3d 1303, 1312 (Fed. Cir. 2005) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration

Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). Claim construction, which is the

determination of the meaning of the terms in a patent, is a question of law exclusively within

the province of the Court. Markman, 517 U.S. at 372. Thus,

The determination of infringement is a two-step process. First,

the court construes the claims to correctly determine the scope

of the claims. Second, it compares the properly construed

claims to the accused device. Claim construction is a matter of

law . . . . However, a determination of infringement, both literal

and under the doctrine of equivalents, is a question of fact.

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Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364, 1372 (Fed. Cir. 2001) (internal

citations omitted).

To interpret claims, the Court first considers the claims themselves. Vitronics Corp.

v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The Court should “look to the

words of the claims themselves” giving them “their ordinary and customary meaning,” unless

clearly stated otherwise. Id. The “ordinary and customary” meaning of a claim term is “the

meaning that the term would have to a person of ordinary skill in the art in question at the

time of the invention . . ..” Phillips, 415 F.3d at 1313; see also Texas Digital Sys., Inc. v.

Telegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir. 2002) (“The terms used in the claims bear

a ‘heavy presumption’ that they mean what they say and have the ordinary meaning that

would be attributed to those words by persons skilled in the relevant art.”). 

In some cases, the ordinary meaning of claim language as understood by someone

skilled in the art may be readily apparent even to lay judges. Phillips, 415 F.3d at 1314. In

such cases, claim construction involves little more than applying the widely accepted

meaning of commonly understood words. Id. General purpose dictionaries may prove

helpful in such circumstances. Id.

After the claims themselves, the Court looks to the patent specification. Vitronics, 90

F.3d at1582. The specification is highly relevant to the claim construction analysis and

usually is dispositive. Id. The specification is the single best guide to the meaning of a

disputed term. Id. The importance of the specification in construing claims derives from its

statutory role. Phillips, 415 F.3d at 1316. The relevance of the written description is

enforced by the statutory requirement that the specification describe the claimed invention

“in full, clear, concise, and exact terms.” Id. (quoting 35 U.S.C. §112). Courts therefore may

rely heavily on the written description of the claims in the specification for guidance when

conducting claim construction. Id. at 1317. 

The specification may give a special definition to a claim term that differs from the

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Like the specification, the inventor created the prosecution history in an attempt to

explain and also to obtain the patent. Phillips, 415 F.3d at 1317. But because the history

represents ongoing negotiations between the PTO and the applicant, rather than the final

product of the negotiations, the prosecution history often lacks the clarity of the specification

and therefore is less useful for claim construction purposes. Id. 

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meaning it otherwise would have. Id. at 1316. In such cases, the inventor’s special

definition, or lexicography, governs. Id. In other cases, the specification intentionally may

disclaim or limit the scope of the claim. Id. In those cases too, the inventor’s decision to

expressly limit the scope of the claim is dispositive. Id.

When reviewing the specification, however, courts must avoid reading limitations

from the specification into the claims. Id. 1323. Distinguishing between using the

specification to interpret the meaning of a claim and importing limitations from the

specification into the claim can be difficult in practice. Id. 

However, the line between construing terms and importing

limitations can be discerned with reasonable certainty and

predictability if the court’s focus remains on understanding how

a person of ordinary skill in the art would understand the claim

terms. For instance, although the specification often describes

very specific embodiments of the invention, we have repeatedly

warned against confining the claims to those embodiments.

Id. (internal citations omitted). To avoid importing limitations, the Court must consider the

purposes of the specification, which are to teach and enable those of skill in the art to make

and use the invention and to provide the best way for doing so. Id. 

In addition to the claims themselves and the specification, courts should consider the

patent’s prosecution history, if in evidence. Phillips, 415 F.3d at 1317. The prosecution

history consists of the record of the proceedings before the Patent and Trademark Office (the

“PTO”) and includes the prior art cited during the examination of the patent. Id. The

prosecution history, which is part of the “intrinsic evidence,” provides evidence of how the

PTO and the inventor understood the patent.2

 Id. The prosecution history often informs the

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“Because dictionaries, and especially technical dictionaries, endeavor to collect the

accepted meanings of terms used in various fields of science and technology, those resources

have been properly recognized as among the tools that can assist the court in determining the

meaning of particular terminology to those of skill in the art of the invention.” Phillips, 415

F.3d at 1318.

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meaning of the claim language by demonstrating how the inventor understood the invention

and whether the inventor limited the invention in the course of the prosecution, thereby

making the claim scope narrower than it otherwise would be. Id. 

Although the intrinsic evidence – the Patent and the prosecution history – is the most

important for claim construction, the Court also may rely on extrinsic evidence if necessary.

Extrinsic evidence is all evidence external to the patent and prosecution history, such as

expert and inventor testimony, dictionaries,3

 and learned treatises. Id. Although it may prove

useful, extrinsic evidence is less significant than the intrinsic record for determining the

meaning of claim language. Id. In most situations, analysis of the patent and its prosecution

history will resolve any ambiguity in a disputed claim term. Vitronics, 90 F.3d at 1583.

Extrinsic evidence in the form of expert testimony can help a court’s construction in

a variety of ways. Phillips, 415 F.3d at 1318. Expert testimony may provide background on

the technology involved, explain how the invention works, ensure that the court’s

understanding of the patent’s technical aspects is consistent with that of a person in the art,

or “establish that a particular term in the patent or the prior art has a particular meaning in

the pertinent field.” Id. But conclusory, unsupported assertions by experts as to the proper

construction of a claim term do not aid the Court. Id. And the Court discounts any expert

testimony “that is clearly at odds with the claim construction mandated by the claims

themselves, the written description, and the prosecution history, in other words, with the

written record of the patent.” Id. (internal quotations omitted).

Although the Court must endeavor to construct the claims as precisely as possible, “a

sound claim construction need not always purge every shred of ambiguity.” Acumed LLC

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v. Stryker Corp., 483 F.3d 800, 806 (Fed. Cir. 2007). Some line-drawing problems may be

left to the trier of fact. Id. 

III. The Patent

The Patent issued on August 17, 2010. (US Patent No. 7,776,355, Ex. A to Plaintiff’s

Opening Claim Construction Brief, Doc. 55-1). The Patent’s field of invention is listed as

drug delivery systems; particularly systems comprised of pads, sealed containers, and liquid

compositions. The Summary of the Invention section of the Patent provides in part:

 The present invention overcomes many of the problems

experienced in the art. In this invention, the dermatologically

active ingredients are insoluble drugs suitable for human or

animal use, and the composition is a liquid comprising one or

more dermatologically active ingredients. The composition is

retained by the pad preferentially over the container.

Dermatologically active ingredients, e.g. without limitation,

BPO, and insoluble antifungals, do not preferentially migrate or

absorb from the composition (e.g. without limitation, emulsion)

onto or into the pad, and therefore does not result in an uneven

concentration of the dermatologically active ingredient in the

composition versus the pad. Further, the pad is packaged in a

container and one or more pads may be packaged in each

container. 

* * *

In accordance with the present invention, insoluble

dermatologically active ingredients are mixed in an emulsion

composition, e.g. without limitation, an oil-in-water emulsion or

a water-in-oil emulsion, preferably an oil-in-water emulsion.

This composition is suited to causing the dermatologically

active ingredient to be substantially uniformly distributed

throughout the composition upon routine mixing during

formulation, and remain so during the product’s shelf life. . . .

Further, the viscosity of the composition is carefully adjusted to

be low enough that the composition will permeate the matrix of

the pad’s fibers and be held on the pad by capillary action.

However, the viscosity must not be so low that the composition

is so thin that it drains off the pad prematurely. On the other

hand, if the viscosity is too high, not only will the composition

fail to be taken into the pad’s fibers’ matrix, it will tend to be

released from the surface of the pad to the walls of the container,

and remain there, unavailable for application to the patient’s

skin.

Use of the present invention by wiping the pad across

skin results in a transfer to the skin of the dermatologically

active ingredient, meaning that the skin is substantially

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“That presumption is especially strong when the limitation in dispute is the only

meaningful difference between an independent and dependent claim, and one party is urging

that the limitation in the dependent claim should be read into the independent claim.”

Acumed, 483 F.3d at 806.

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uniformly medicated. During this wiping, an adequate

therapeutic dose of the dermatologically active ingredient is

delivered to the skin. One advantage of this invention may be

a reduced irritation to the skin as comparted to similar

compositions applied without the pad.

***

(Doc. 55-1, Column “Col.” 2-3).

The Patent issued with four independent claims – claims 1, 2, 8, and 9 – and twenty

dependent claims. A dependent claim is written by specifically referencing another claim.

35 U.S.C. §112. A dependent claim does not recite the elements of the referenced

independent claim, but is construed to incorporate all of the limitations of that claim. Id. A

dependent claim also specifies a further limitation of the subject matter claimed. Id.

Independent claims are presumed to have broader scope than their dependents. Acumed, 483

F.3d at 806. In fact, the presence of a particular limitation in a dependent claim raises a

presumption that the limitation is not found in the independent claim. Id.

4

All of the disputed terms are in the independent claims. The independent claims read:

What is claimed is:

1. A drug delivery system comprising

a pad;

a container; and

a liquid composition, wherein the composition comprises:

(1) an effective amount of one or more insoluble

dermatologically active ingredients, and (2) an emulsion vehicle

for the dermatologically active ingredients, wherein the

composition has a viscosity which is low enough for the

composition to substantially uniformly absorb onto the pad via

capillary action, and high enough to be substantially retained on

the pad, not the container, and

wherein the active ingredient comprises benzoyl peroxide

particles of less than 50 microns.

2. A drug delivery system comprising

a pad;

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a container; and

a liquid composition, wherein the composition comprises:

(1) an effective amount of one or more insoluble

dermatologically active ingredients, and (2) an emulsion vehicle

for the dermatologically active ingredients, wherein the

composition has a viscosity which is low enough for the

composition to substantially uniformly absorb onto the pad via

capillary action, and high enough to be substantially retained on

the pad, not the container, and wherein the active ingredient

comprises particles of about 10 to about 150 microns.

***

8. A drug delivery system comprising

a pad;

a container; and

a liquid composition, wherein the composition comprises:

(1) an effective amount of one or more insoluble

dermatologically active ingredients, and (2) an emulsion vehicle

for the dermatologically active ingredients, wherein the

composition has a viscosity which is low enough for the

composition to substantially uniformly absorb onto the pad via

capillary action, and high enough to be substantially retained on

the pad, not the container, and wherein the active ingredient

comprises particles of up to about 300 microns.

9. A drug delivery system comprising

a pad;

a container; and

a liquid composition, wherein the composition comprises:

(1) an effective amount of one or more insoluble

dermatologically active ingredients, and (2) an emulsion vehicle

for the dermatologically active ingredients, wherein the

composition has a viscosity which is low enough for the

composition to substantially uniformly absorb onto the pad via

capillary action, and high enough to be substantially retained on

the pad, not the container, and wherein the active ingredient

comprises particles of less than 50 microns.

***

(Doc. 55-1, Col. 7- Col. 8).

IV. Claim Construction

The following chartsummarizesthe Court’s construction of the disputed claim terms.

The analysis supporting the constructions follows.

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Disputed Claim Term Construction

Pad Includes, but is not limited to, pads,

pledgets, towels, towelettes, cloths, and

sponges that may be of woven or nonwoven

material, may be of synthetic or natural

material, and may comprise more than one

layer. 

Container Packaging that contains one or more pads,

does not leak the composition, and does

not degrade excessively over time once it

is sealed.

Effective Amount Adequate therapeutic dose.

Viscosity which is low enough for the

composition to substantially uniformly

absorb onto the pad via capillary action,

and high enough to be substantially

retained on the pad, not the container.

Viscosity which is low enough for the

composition to substantially uniformly

absorb onto the pad via capillary action,

and high enough to be substantially

retained on the pad, not the container, but

less than 10,000 centipoise.

A. Pad

Plaintiff offers the following definition of pad: “A pad is a component of the drug

delivery system that is woven or nonwoven and includes, but is not limited to pads, pledgets,

towels, towelettes, cloths, and sponges.” (Doc. 133, p.2). Defendant suggests the following

construction: “Pads, pledgets, towels, towelettes, cloths and sponges; the pads may be woven

or non-woven material, may be made of synthetic or natural material and may comprise more

than one layer. There is no limitation on the material used to form the pad or its

characteristics (such as porosity or absorption) that affect interaction with the composition.”

(Id.)

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The Court adopts neither construction, but draws its own slightly different

construction from the claims themselves and the specification. The claims provide that the

pad is the material that is used in the drug delivery system to absorb and then deliver the

drugs to the skin. The specification elaborates on the type of material. The specification

provides that “pads include but are not limited to pads, pledgets, towels, towelettes, cloths,

and sponges; the pads may be woven or nonwoven material;” that the pad “may be made of

synthetic or natural material;” and that “materials for the pad may comprise more than one

layer.” (Doc. 55-1, Col. 2; 51-53 & Col. 4; 46-47 & 52). 

The Court has chosen a construction that tracks the specification more closely than

either proposed construction, and the specification is the single best guide to the meaning of

a disputed term. Vitronics, 90 F.3d at 1582. The Court’s definition does not contain the

extraneous verbiage suggested by Defendant that is not found in the specification, and

contains more description from the specification than suggested by Plaintiff. The Court finds

the ordinary and customary meaning of the term “pad” as used in the Patent and understood

by a person of ordinary skill in the art, see Phillips, 415 F.3d at 1313, means “Includes, but

is not limited to, pads, pledgets, towels, towelettes, cloths, and sponges that may be of woven

or nonwoven material, may be of synthetic or natural material, and may comprise more than

one layer.” 

B. Container

Plaintiff asks the Court to construe container as “a structure that contains one more

pads, does not leak the composition, nor does it degrade excessively over time once it is

sealed.” (Doc. 155, p.3). Defendant argues the Court should construe container as “Any

material that packages the pad with the composition and does not degrade or leak the

composition for a sufficient period of time, such as shelf life of the invention. There is no

limitation on the material used to form the container or its characteristics that affect

interaction with the composition.” (Id.). 

The Court essentially has adopted Plaintiff’s proposed definition with only slight

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wording changes. Plaintiff and the Court derive this meaning from the specification.

Regarding the container, the specification reads: “Packaging for the pad has an additional set

of considerations. A container may contain one or more pads, does not leak the composition

nor does it degrade excessively over time once it is sealed.” (Doc. 55-1, Col. 4; 61-64).

Defendant also quotes from the specification, but adds language not found in the

specification or the claims. 

The Court does not need to look beyond the specification for the construction of

“container” and finds no need to augment the claim term with language not found in the

specification. The Court therefore finds that the ordinary and customary meaning of the term

“container” as used in the Patent and understood by person of ordinary skill in the art means:

“Packaging that contains one or more pads, does not leak the composition, and does not

degrade excessively over time once it is sealed.”

C. Effective Amount

Plaintiff proposes the following construction of the term “effective amount”: “An

effective amount of a dermatologically active ingredient means an adequate therapeutic dose

will be delivered to the skin by wiping the pad onto the skin.” (Doc. 133, p.3). Defendant’s

proffered definition builds on Plaintiff’s and adds a limitation: “An adequate therapeutic dose

delivered to the skin by wiping the pad onto the skin meaning the skin is uniformly

medicated; provided, the dermatologically active ingredients are particles of a size within the

range recited by the patent claim.” (Id.). 

The specification provides that an “effective amount of the dermatologically active

ingredient means an adequate therapeutic dose will be delivered to the skin by wiping the pad

onto the skin.” (Doc. 55-1, Col. 3; 30-32). The Court reads that phrase as if it had a comma

and the word “which” before the word “will,” i.e. “effective amount of the dermatologically

active ingredient means an adequate therapeutic dose, which will be delivered to the skin by

wiping the pad onto the skin.” In other words, the Court finds that the specification’s

definition of “effective amount” – therapeutic dose – is found in the first clause and that the

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second part of the sentence describes the method of delivery for the effective amount.

The Court finds that this interpretation of the specification comports with the ordinary

meaning of the claim term as understood by someone in the art, which is apparent even to

a lay judge. Phillips, 415 F.3d at 1314. When a term’s meaning is apparent even to a lay

judge, claim construction involves little more than applying the widely accepted meaning of

commonly understood words. Id. General purpose dictionaries may prove helpful in such

circumstances. Id. 

Random House defines “effective” as “adequate to accomplish a purpose; producing

the intended or expected result” and “amount” as “quantity; measure.” Dictionary.com

Unabridged. Random House, Inc. 16 Feb. 2011. <Dictionary.com

http://dictionary.reference.com/browse/effective>. So, the “effective amount” is the quantity

of dermatologically active ingredients that is adequate to produce the intended result. The

word “therapeutic” in the construction indicates that the intended result is curative and

medicinal.

Both Plaintiff and Defendant have suggested constructions that include phrases about

the method for delivering the adequate dose to the skin. Defendant goes even further and

includes a requirement that the dermatologically active ingredients’ particle sizes be within

a certain range. But the quantity of drugs needed to treat the skin is separate from the

Patent’s innovative delivery system for uniformly delivering that quantity. Nor does the

Court find that the specification dictates the inclusion of the method of delivery in the

definition of “effective amount” if read how the Court has explained. Further, nothing in the

intrinsic evidence argues for including a particle size limitation for the dermatologically

active ingredients in the definition of effective amount. 

When construing “effective amount,” the Court need only apply the widely accepted

meaning of commonly understood words. “Amount” is a quantitative term, which is

modified in the Patent by “effective.” The Court finds that the ordinary and customary

meaning of the term “effective amount”within the meaning of the Patent is an “adequate

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Centipoise is a unit of viscosity equal to one hundredth of a poise. 

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therapeutic dose.”

D. Viscosity That is Low Enough to Allow the Composition . . .

1. Indefiniteness 

Defendant argues that the Court cannot construe the viscosity phrase because it fails

for indefiniteness. Defendant argues in the alternative that the Court construe the phrase with

a viscosity range of 500 to less than 10,000 centipoise.5

 The Court will address the

indefiniteness argument first. 

The definiteness requirement of the Patent Act requires a specification to conclude

with claims that particularly point out and distinctly claim the subject matter that the inventor

regards as her invention. Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1320 (Fed. Cir.

2003). Deciding whether a claim term is indefinite requires analysis of whether a person

skilled in the art would understand the bounds of the claim when read in light of the patent.

Id. at 1320-21 (internal citations omitted). The Act’s definiteness requirement ensures that

the patent’s claims delineate the scope of the invention with language that adequately notifies

the public of the patentee’s right to exclude. Young v. Lumenis, Inc., 492 F.3d 1336, 1346

(Fed. Cir. 2007). “If the claims read in light of the specification reasonably apprise those

skilled in the art of the scope of the invention, §112 demands no more.” Omega, 334 F.3d

at 1321. 

Claims are considered indefinite if they are not “amenable to construction or are

insolubly ambiguous.” Young, 492 F.3d at 1346 (internal citations omitted). A claim is

insolubly ambiguous only if a person of ordinary skill in the art could not determine the

bounds of the claims. Halliburton Energy Serv., Inc. v. M-I LLC, 514 F.3d 1244, 1249 (Fed.

Cir. 2008). Claim terms are not indefinite merely because they present difficulties in claim

construction. Id. “[I]f the meaning of the claim is discernible, even though the task may be

formidable and the conclusion may be one over which reasonable persons will disagree, we

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have held the claim sufficiently clear to avoid invalidity on indefiniteness grounds.” Id.

(internal citations omitted). 

When determining definiteness, the general principles of claim construction apply.

Young, 492 F.3d at 1346. The Court first and primarily considers the intrinsic evidence. Id.

But the Court also may rely on extrinsic evidence, such as expert testimony. Phillips, 415

F.3d at 1317.

The Court begins its analysis with the presumption that the Patent is valid as drafted.

Young, 492 F.3d at 1345. An accused infringer has the burden of demonstrating invalidity

by clear and convincing evidence. Id. Proof of indefiniteness requires such exacting

evidence because claim construction often poses a difficult task over which experts and

judges may disagree. Halliburton, 514 F.3d at 1249. Defendant can meet this burden by

showing by “clear and convincing evidence that a skilled artisan could not discern the

boundaries of the claim based on the claim language, the specification, and the prosecution

history, as well as her knowledge of the relevant art area.” Id. at 1249-50.

The Patent specification emphasizes the importance of the viscosity range to the

invention’s ability to deliver an adequate and uniform amount of dermatological drugs to the

skin:

Further, the viscosity of the composition is carefully adjusted to

be low enough that the composition will permeate the matrix of

the pad’s fibers and will be held on the pad by capillary action.

However, the viscosity must not be so low that the composition

is so thin that it drains off the pad prematurely. On the other

hand, if the viscosity is too high, not only will the composition

fail to be taken into the pad’s fibers’ matrix, it will tend to be

released from the surface of the pad to the walls of the container,

and remain there, unavailable for application to the patient’s

skin.

(Doc. 55-1, Col. 3; 5-16). The prosecution history distinguishes the invention from prior art

in part based on the Patent’s preferable level of viscosity for retention and uniform

application of the dermatologically ingredients. (See, e.g., June 5, 2006 Request for

Reconsideration, Doc. 85-15, p.17)(“[T]he art of record, especially the ‘237 Patent, teaches

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away from a low viscosity by teaching the use of thickeners to achieve a high viscosity . . .

In contrast to the high viscosities of the ‘237 Patent, the viscosities of the present invention

are significantly lower and the specific values are necessary for the present invention to

work.”). 

The specification teaches that the viscosity of the liquid composition must be within

a range that is both low enough to allow uniform permeation of the pad and high enough for

the composition to stay on the pad and not the container. The independent claims discuss the

parameters for the viscosity range in functional, rather than quantitative, terms, which

nonetheless are ascertainable by visual inspection of the pad and the container. (Fed. Cir.

2003). The Court therefore finds that a person skilled in the art of topical drug delivery

systems, Omega, 334 F.3d at 1320-21, would understand the functional boundaries for the

viscosities as described in the independent claims. 

The testimony and declarations of Mr. Bogardus, a person highly skilled in the art of

topical drug delivery systems, support the Court’s finding. Mr. Bogardus testified that one

skilled in the art would understand readily the Patent’s functional description of viscosity.

He explained that viscosity can be described functionally and that functional viscosity can

be ascertained by observation of the functional behavior of the liquid. And he testified that

the ability to observe how viscosity functions in a product is within the skill set of people

working in the field of dermatological formulations. 

Defendant offers only the Declarations of Edith Mathiowitz to support its

indefiniteness claim. In her Declaration in support of Acella’s claim construction brief, Dr.

Mathiowitz states that the claims’ viscosity term “does not provide any substantial

information that would allow a person of ordinary skill to formulate the delivery system.”

(December 17, 2010 Declaration of Dr. Edith Mathiowitz, Doc. 81-2, ¶8). Dr. Mathiowitz

suggests that the composition’s viscosity description requires the specification of parameters

not recited in the Patent, such as particle size distribution and particle volume fraction. (Id.

¶9). 

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The Court notes that the PTO issued the Patent after initially rejecting the claims

based in part on indefiniteness. (See, e.g., September 28, 2005 Amendment and Request for

Reconsideration, Doc. 85-14, pp.6-8).

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Dr. Mathiowitz’s conclusory assertions do not provide much aid to the Court.

Phillips, 415 F.3d at 1318. They certainly do not rise to the level of the clear and convincing

evidence required to demonstrate the invalidity of the Patent. Young, 492 F.3d at 1345. The

Court therefore finds that the viscosity term is sufficiently definite and will proceed to

construct the term.6

2. Construction

Plaintiff proposes the following claim construction for the viscosity term: “Viscosity

is low enough to achieve the function of becoming absorbed onto the pad, and high enough

to achieve the function of being substantially retained on the pad, not the container.” (Doc.

133, p.4). As an alternative to finding the term indefinite, Defendant suggests the following

definition: “The composition has a viscosity in the range of 500 to less than 10,000 cps and

is low enough that the composition will permeate the matrix of the pad’s fibers and be held

on the pad by capillary action.”

Defendant argues, pursuant to the doctrine of prosecution history estoppel, that

Plaintiff has limited the scope of its claims to liquid compositions with viscosities less than

10,000 centipoise (“cps”). Plaintiff counters that the doctrine of prosecution history estoppel

does not apply to a claim of literal infringement and that the doctrine of claim differentiation

prohibits the insertion of limitations from dependent claims into the independent claim. 

Plaintiff correctly argues that the presence of a limitation, such as the centipoise

limitations here, in a dependent claim raises a presumption that the limitation is not present

in the independent claim. Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1360 (Fed.

Cir. 2010)(citing Phillips, 415 F.3d at 1315)(emphasis added). But presumptions can be

overcome. Further, the Court’s construction of the viscosity phrase does not import

limitations from the dependent claims. Rather, it narrows the term based on Plaintiff’s

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specific disavowals. 

Plaintiff also correctly notes that the doctrine of prosecution history estoppel does not

apply if literal infringement may exist, as Plaintiff alleges here. Fromson v. Advance Offset

Plate, Inc., 720 F.2d 1565, 1571 (Fed. Cir. 1983). Instead, prosecution disclaimer, which is

similar to prosecution history estoppel, applies in literal infringement cases. Omega, 334

F.3d at 1326 n.1. Plaintiff argues that prosecution disclaimer also does not apply because the

patent applicants did not clearly disavow the scope of their claims.

The Court begins with a heavy presumption that claim terms carry their full ordinary

and customary meaning, unless the patentee expressly relinquishes claim scope during

prosecution. Omega, 334 F.3d at 1323. Pursuant to the doctrine of prosecution disclaimer,

“a patentee may limit the meaning of a claim term by making a clear and unmistakable

disavowal of scope during prosecution.” Purdue Pharma L.P. v. Endo Pharmaceuticals Inc.,

438 F.3d 1123, 1136 (Fed. Cir. 2006). Disavowal may occur, for instance, when the patentee

“explicitly characterizes an aspect of his invention in a specific manner to overcome prior

art.” Id. The doctrine of prosecution disclaimer precludes patentees from recapturing

meanings through claim interpretation that they disclaimed during prosecution. Omega, 334

F.3d at 1323.

To limit the scope of a claim, alleged disavowing statements must be both clear and

unmistakable. Id. 1325-26. The patentee must have taken a position before the PTO that

would lead a competitor to believe that the applicant had disavowed coverage of the relevant

subject matter. Id at 1325 (citing Schwing GmbH v. Putzmeister Aktiengesellschaft, 305 F.3d

1318, 1324-25 (Fed. Cir. 2002)). But if a patentee “has unequivocally disavowed a certain

meaning to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the

ordinary meaning of the claim congruent with the scope of the surrender.” Id. at 1324.

After reviewing the prosecution history, the Court finds that the applicants took a

position before the PTO that would lead competitors to believe that they had disavowed

coverage of liquid compositions with viscosities of 10,000 cps or greater. See Omega, 334

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F.3d at 1325. In arguing against the PTO Examiner’s rejection of claims 4, 5, and 8-12 as

obvious in light of U.S. Patent No. 5,562,642, the applicants asserted, in relevant part:

The Examiner has rejected claims 4, 5, and 8-12 under 35

U.S.C. §103 on the basis of a single reference: the ‘642 Patent.

In advancing this rejection, the Examiner again concedes that

the ‘642 Patent does not teach the particle size and viscosity

limitations of these claims. Indeed, the ‘642 Patent makes no

mention of the viscosity of the liquid that is applied to the pad

or cloth. . . . 

At page 6 of the Office Action the Examiner states that

“the composition disclosed by US ‘642 . . . comprises the same

elements disclosed by applicants that are retained in [the] pad of

non-woven material inside [a] container made of metal and

plastic.” This statement is true only in that the reference

discloses a liquid that has insoluble particles on a pad in a

container. The ‘642 Patent does not mention viscosity or

particle size at all, much less the specific ranges called for by

claims 4, 5, and 8-12. . . . 

The Examiner supplies the missing viscosity claim

element by asserting that “it is expected” that the viscosity

would be the same. This assertion is flatly contradicted by the

art of record. The ‘642 Patent does not mention the viscosity of

the liquid that is delivered. The only reference of record in this

application that mentions the viscosity of a liquid delivered by

a pad is the ‘237 Patent, which describes viscosities of from

10,000 to 300,000 centipoise, which is in excess of the range

called for by the claimed invention. Applicant has pointed this

out, but the Examiner has responded that “one cannot show

nonobviousness by attacking references individually where the

rejections are based on a combination of references.” In this, the

Examiner states a proposition that, while true, is irrelevant to

this application. In the entire body of prior art of record there is

only one disclosure of the viscosity of the liquid on the pad, and

in that disclosure the viscosity is well outside the claimed range,

e.g., “most preferably from about 50,000 to 150,000 centipoise.”

In pointing this out, the Applicant is not attacking the references

individually. The Applicant is pointing out that the only

viscosity disclosures in the entire body of art fails to disclose or

suggest the viscosity claim limitation, and that the art of record

suggest that one should use liquids that do not meet the viscosity

limitation of the pending claims.

(Doc. 85-15, pp.12-13)(emphasis added).

In response to the Examiner’s rejection of Claim 19 pursuant to 35 U.S.C. §103(a) as

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At the time of the June 5, 2006 Request for Reconsideration, Claim 19 read in

pertinent part, “wherein the composition has a viscosity which is low enough for the

composition to be substantially uniformly absorb [sic] onto the pad via capillary action, and

high enough to be substantially retained on the pad, not the container.” (Doc. 85-15, p.4).

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being unpatentable over prior art,7

 the applicants again emphasized the importance of the

lower viscosity of the claimed invention. The applicants argued: 

Additionally, as discussed above, the art of record, especially

the ‘237 Patent, teaches away from a low viscosity by teaching

the use of thickeners to achieve high viscosity. For the example,

the ‘237 Patent states that, “[p]referred emulsions have a high

viscosity, of from about 10,000 to about 300,000 centipoise,

more preferably from about 20,000 to about 200,000 centipoise,

most preferably from about 50,000 to about 150,000 centipoise.”

Column 13, lines 25-28. In contrast to the high viscosities of the

‘237 Patent, the viscosities of the present invention are

significantly lower and the specific values are necessary for the

present invention to work. . . . Therefore, the ‘237 Patent teaches

away from a composition having a low enough viscosity for the

composition to substantially uniformly absorb onto the pad via

capillary action and high enough to be substantially retained on

the pad not the container.

(Doc. 85-15, p.17)(emphasis added).

 Before the PTO, the Patent applicants specifically characterized their invention’s

liquid composition’s viscosity as being below the range of 10,000 to 300,000 centipoise to

differentiate the invention from prior art. Moreover, they emphasized that the specified

lower viscosities were necessary in order for the claimed invention to work. See Purdue

Pharma, 438 F.3d at 1136 (holding patentee did not disclaim all non-four-fold dosage ranges

during prosecution where patentee did not present the four-fold dosage range as a necessary

feature of the claimed formulations). The Court therefore holds that the Patent applicants

clearly and unmistakably disavowed liquid compositions with viscosities of 10,000 cps and

greater in order to overcome prior art. See Purdue Pharma, 438 F.3d at 1136. Consequently,

prosecution disclaimer applies and limits the scope of the Patent’s claims to liquid

compositions having viscosities of less than 10,000 cps.

 The Court finds that it does not need to construe the viscosity phrase in the

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independent claims because the phrase is plain on its face and would be understood by a

person skilled in the art of topical drug delivery systems. The Court, however, adds the

limitation regarding viscosity centipoise in order to narrow the ordinary meaning of the

phrase to be congruent with the scope of the applicants’ clear disavowal. The Court therefore

holds that the meaning of the term “viscosity which is low enough for the composition to

substantially uniformly absorb onto the pad via capillary action, and high enough to be

substantially retained on the pad, not the container”within the Patent is “Viscosity which is

low enough for the composition to substantially uniformly absorb onto the pad via capillary

action, and high enough to be substantially retained on the pad, not the container, but less

than 10,000 centipoise.” 

V. Conclusion

For the foregoing reasons, the Court construes the four disputed claim terms as set

forth in the table above.

IT IS SO ORDERED.

DATED this 2nd day of March, 2011.

 

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