# VALEANT PHARMACEUTICALS NORTH AMERICA LLC v. ZYDUS PHARMACEUTICALS (USA) INC.

> District Court, D. New Jersey · January 11, 2021

URL: https://www.frixlaw.com/law-library/cases/10269740

## Case

- **Court:** District Court, D. New Jersey
- **Decided:** January 11, 2021
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10269740

## How later opinions describe it (automated extraction)

- rejecting the argument that claim differentiation did not apply between two claims because the disputed term in the two claims covered different subject matters, and finding the term covered the same subject matter in the two claims
- finding a similar first paragraph6 of the summary of the invention limits the scope of the invention

## Opinion text

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY

IN RE JUBLIA Case No. 3:18-cv-13635 (BRM) (LHG)

OPINION

MARTINOTTI, DISTRICT JUDGE
Before this Court are the applications by Plaintiffs Bausch Health US, LLC, Bausch Health
Ireland Limited, Bausch Health Americas, Inc., and Kaken Pharmaceutical Co., Ltd. (“Karen”)
(collectively, “Plaintiffs”) and Defendants Aleor Dermaceuticals Ltd. (“Aleor”), Aurobindo
Pharma Limited and Aurobindo Pharma USA Inc. (collectively, “Aurobindo”), KVK-Tech, Inc.
(“KVK”), Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”), and Zydus
Pharmaceuticals (USA) Inc., Zydus Worldwide DMCC, and Cadila Healthcare Limited
(collectively, “Zydus”) (together with Aleor, Aurobindo, KVP, and Lupin, “Defendants”) for
claim construction to resolve disputes over two claim terms: “bottom portion” and “tip portion.”
(ECF Nos. 190–91 & 204–05.)
This Court has examined the disputes over the construction of these claim terms and, for
the reasons set forth in this Opinion, and for good cause shown, this Court defines the disputed
claim term “bottom portion” to mean “the lateral surface that is bonded to the tubular body,” and
“tip portion” to mean “the fan-shaped end of the columnar brush member.”
I. BACKGROUND
A. Factual Background
This case arises out of an action for infringement of Karen’s patent, U.S. Patent No.
10,478,601 (“the ’601 patent”), by Defendants’ filing of an Abbreviated New Drug Application
(“ANDA”) seeking U.S. Food and Drug Administration (“FDA”) approval to market a generic
version of Plaintiffs’ product Jublia®—an efinaconazole topical solution, 10%. (ECF No. 191 at
5.)
On November 19, 2019, the United States Patent and Trademark Office (“PTO”) issued

the ’601 patent, which describes a solution applicator “with which irritation on an affected part of
a patient may be reduced even when a solution is used.” (ECF No. 191-2 at 3.) Onychomycosis is
an infection of the nail unit caused by fungi. (ECF No. 191 at 6–7.) The parties dispute the proper
construction of two claim terms “bottom portion” and “tip portion” used in the ’601 patent. The
chart below sets forth the parties’ proposed constructions.
Claim Language Asserted Claims Plaintiffs’ Proposed Defendants’
Construction Proposed
Construction
“bottom portion” ’601 patent claim 8 Plain and ordinary “the lateral surface
meaning, i.e., “the that is bonded to the
lateral surface that is lowest end of the
bonded to the tubular tubular body of the
body” bottomed tubular
holder”
“tip portion” ’601 patent claim 8 Plain and ordinary “fan-shaped end of the
meaning, i.e., “end columnar brush
portion of the member”
columnar brush
member”

B. Procedural History
On September 6, 2018, Plaintiffs filed a Complaint asserting claims of infringement against
Defendants. (ECF No. 1.) On March 5, 2019, Defendants filed an Answer to the Complaint along
with counterclaims asserting the noninfringement and invalidity of the patents-in-suit. (ECF No.
20.)
On September 18, 2020, both Plaintiffs and Defendants filed their opening Markman briefs.
(ECF Nos. 190 & 191.) On October 7, 2020, both Plaintiffs and Defendants filed their Markman
reply briefs. (ECF Nos. 204 & 205.)1
II. LEGAL STANDARD

Claims define the scope of the inventor’s right to exclude. Phillips v. AWH Corp., 415 F.3d
1303, 1312 (Fed. Cir. 2005). Claim construction determines the correct claim scope and is a
determination reserved exclusively for the court as a matter of law. Markman v. Westview
Instruments, Inc., 52 F.3d 967, 978–79 (Fed. Cir. 1995) (en banc). Indeed, the court can only
interpret claims and “can neither broaden nor narrow claims to give the patentee something
different than what [it] has set forth” in the specification. E.I. Du Pont de Nemours & Co. v.
Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir. 1998). A court’s determination “of patent
infringement requires a two-step process: first, the court determines the meaning of the disputed
claim terms, then the accused device is compared to the claims as construed to determine
infringement.” Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007).

This interpretive analysis begins with the language of the claims, which is to be read and
understood as it would be by a person of ordinary skill in the art. Dow Chem. Co. v. Sumitomo
Chem. Co., 257 F.3d 1364, 1372 (Fed. Cir. 2001); see also Markman v. Westview Instruments,
Inc., 52 F.3d 967, 986 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996) (holding that “[t]he
focus [in construing disputed terms in claim language] is on the objective test of what one of
ordinary skill in the art at the time of invention would have understood the term to mean”); Phillips,
415 F.3d at 1312–13. In construing the claims, the court may examine both intrinsic evidence (e.g.,

1 Plaintiffs and Defendants agreed a claim construction hearing is not necessary because the issues
can be decided on the papers without argument. (ECF No. 206.)
the patent, its claims, the specification, and the prosecution history) and extrinsic evidence (e.g.,
expert reports and testimony). Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1309
(Fed. Cir. 1999).
The analysis of claim language begins with determining the “ordinary and customary

meaning of a claim term[, which] 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, i.e., as of the effective filing date of the
patent application.” Phillips, 415 F.3d at 1313. Further, the language should not be read solely in
the context of the claim under review; instead, it should be analyzed “in the context of the entire
patent” and with an understanding of how that language is used in the field from which the patent
comes. Id. In conducting this review, a different interpretation is placed on a term located in an
independent claim than on those located in dependent claims, and it is understood that each claim
covers different subject matters. Saunders Grp., Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1331
(Fed. Cir. 2007) (quoting Phillips, 415 F.3d at 1315 (holding that “the presence of a dependent
claim that adds a particular limitation gives rise to a presumption that the limitation in question is

not present in the independent claim”)).
In reviewing the language of a patent, “the court starts the decision-making process by
reviewing the same resources as would [a person or ordinary skill in the art in question], viz., the
patent specifications and the prosecution history.” Phillips, 415 F.3d at 1313 (quoting Multiform
Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)). When “the ordinary
meaning of claim language as understood by a person of skill in the art [is] readily apparent,”
understanding claim construction “involves little more than the application of the widely accepted
meaning of commonly understood words.” Phillips, 415 F.3d at 1314. “In such circumstances,
general purpose dictionaries may be helpful” to explain the terms used. Id.
Often times, however, the ordinary meaning of the claim language is not readily apparent,
and in such circumstances, courts look to “those sources available to the public that show what a
person of skill in the art would have understood disputed claim language to mean.” Id. (quoting
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004).

Those sources may include “the words of the claims themselves, the remainder of the specification,
the prosecution history, and extrinsic evidence concerning relevant scientific principles, the
meaning of technical terms, and the state of the art.” Id. Furthermore, claims must be read in view
of the claim specification, which is of seminal importance in providing framework for
understanding the claim language. As the Federal Circuit in Markman explained:
The specification contains a written description of the invention that
must enable one of ordinary skill in the art to make and use the
invention. For claim construction purposes, the description may act
as a sort of dictionary, which explains the invention and may define
terms used in the claims. As we have often stated, a patentee is free
to use his [or her] own lexicographer. The caveat is that any special
definition given to a word must be clearly defined in the
specification. The written description part of the specification itself
does not delimit the right to exclude. That is the function and the
purpose of the claims.

Markman, 52 F.3d at 979–80.

This Court’s reliance on the specification is appropriate given the Patent and Trademark
Office’s rules requiring “that application claims must ‘conform to the invention as set forth in the
remainder of the specification and the terms and phrases used in the claims must find clear support
or antecedent bases in the description so that the meaning of the terms in the claims may be
ascertainable by reference to the description.’” Phillips, 415 F.3d at 1316–17 (quoting 37 C.F.R.
§ 1.75(d)(1)). During this analysis, however, courts should not “import limitations from the
specifications into the claims.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1370 (Fed. Cir.
2008) (quoting CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005)).
The patent’s prosecution history is also of “primary significance in understanding the
claims.” Markman, 52 F.3d at 980. “The prosecution history can often inform the meaning of the
claim language by demonstrating 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.” Phillips, 415 F.3d at 1317. Further, the prosecution history is also relevant
to determining whether the patentee disclaimed or disavowed the subject matter, thereby
narrowing the scope of the claim terms. Seachange Int’l, Inc. v. C-Cor Inc., 413 F.3d 1361, 1372–
73 (Fed. Cir. 2005).2
In addition to intrinsic evidence, a court may also rely on extrinsic evidence in interpreting
a claim. Phillips, 415 F.3d at 1317. Extrinsic evidence “consists of all evidence external to the
patent and prosecution history, including expert and inventor testimony, dictionaries, and learned
treatises.” Id. (citations omitted). However, while extrinsic evidence “can shed useful light on the

2 “[I]n certain cases, ‘the specification may reveal an intentional disclaimer, or disavowal, of claim
scope by the inventor.’” Ventana Med. Sys., Inc. v. Biogenex Labs., Inc., 473 F.3d 1173, 1181
(Fed. Cir. 2006) (quoting Phillips, 415 F.3d at 1316) (internal citations omitted). In such cases, the
Federal Circuit interprets the claim more narrowly than it otherwise would in order to give effect
to the patentee’s intent to disavow a broader claim scope. Ventana, 473 F.3d at 1181 (citing
Honeywell Int’l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1319-20 (Fed. Cir. 2006); SciMed Life
Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1342-44 (Fed. Cir. 2001)).
However, pointing solely to “general statements by the [patentee] indicating that the invention is
intended to improve upon prior art” will not demonstrate that the patentee intended to “disclaim
every feature of every prior art device discussed in the ‘BACKGROUND ART’ section of the
patent.” Ventana, 473 F.3d at 1181; see also Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d
1362, 1366 (Fed. Cir. 2012) (“Mere criticism of a particular embodiment encompassed in the plain
meaning of a claim term is not sufficient to rise to the level of clear disavowal.”). Moreover, the
Federal Circuit has found it “particularly important not to limit claim scope based on statements
made during prosecution ‘[a]bsent a clear disavowal or contrary definition.’” Digital-Vending
Servs. Int’l, LLC v. Univ. of Phx., Inc., 672 F.3d 1270, 1276 (Fed. Cir. 2012) (citing August Tech.
Corp. v. Camtek, Ltd., 655 F.3d 1278, 1286 (Fed. Cir. 2011) (quoting Home Diagnostics, Inc. v.
LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004))). The reason for such a stringent rule is
“because the prosecution history represents an ongoing negotiation between the PTO and the
applicant,” and “it often lacks the clarity of the specification and thus is less useful for claim
construction purposes.” Digital Vending, 672 F.3d at 1276 (quoting Phillips, 415 F.3d at 1317).
relevant art,” it is “less significant that the intrinsic record in determining the legally operative
meaning of claim language.” Id. Extrinsic evidence should be “considered in the context of
intrinsic evidence,” as there are flaws inherent in the exclusive reliance on extrinsic evidence,
including, inter alia, biases, inadvertent alterations of meanings, and erroneous contextual

translations. Id. at 1318–19. Furthermore, extrinsic evidence should not be relied upon where “an
analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term.”
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996).
III. DECISION
This Court addresses the interpretation of two disputed claim terms “bottom portion” and
“tip portion.”
A. The Meaning of “Bottom Portion”
Plaintiffs propose “bottom portion” be construed to have its plain and ordinary meaning,
i.e., “the lateral surface that is bonded to the tubular body” (ECF No. 191 at 21), whereas
Defendants propose “bottom portion” be construed to mean “the lateral surface that is bonded to

the lowest end of the tubular body of the bottomed tubular holder” (ECF No. 190 at 12).
Plaintiffs contend the bottom portion does not have to be at the lowest end of the tubular
body. (ECF No. 191 at 22.) First, no language in the claims or the specification suggests the bottom
portion must be bonded to the lowest end. (Id. at 22, 24.) To the contrary, claim 8 states one
purpose of the bottom portion is to provide a pore that controls the amount of solution moving
from the solution container to the bottomed tubular holder. (ECF No. 205 at 6.) Fulfilling this
purpose does not require the pore to be at the lowest end of the tubular body. (Id.) Second, the
embodiments in Figures 18 and 22 of the specification contain a space between the lowest end of
the tubular body and the bottom portion, thereby confirming the bottom portion is not limited to
the lowest end. (Id. at 8.) Third, Plaintiffs refer to certain dictionary definitions for “bottom” as
the lowest point or surface inside something, which does not have to also be the lowest end of that
something. (ECF No. 191 at 26.)
However, Defendants argue the bottom portion must be at the lowest end of the tubular

body. (ECF No. 190 at 12.) First, the language of claim 8 states the solution must pass through the
pore to enter into the bottomed tubular holder. (Id. at 14.) Therefore, the bottom portion, where
the pore is located, must be located at the lowest end of the bottomed tubular holder. (Id.)
Otherwise, the solution could enter the bottom tubular holder without first passing through the
pore. (Id.) Moreover, Plaintiffs’ construction allows the bottom portion to be bonded anywhere
along the tubular body, including at the top. (Id. at 16.) If the bottom portion is bonded at the top
of the tubular body, the solution would exit the bottomed tubular holder through the pore, which
contradicts the language of claim 8. (Id.) Second, the specification repeatedly uses “bottom”
consistent with its plain meaning offered by Defendants. (Id.) Each time the word “bottom” is
used, it spatially refers to the “lowest” part of the component it is discussing, such as the bottom

portion of the solution container, the bottom face of the annular flange and the solution container,
and a schematic bottom view illustrating a lid member viewed from below. (Id. at 16–18.) Third,
as for the embodiments in Figure 18, Defendants maintain the space between the absolute bottom
of the tubular body and the bottom portion is nominal. (ECF No. 204 at 13.) It is simply the result
of the design of the bottomed tubular holder, which requires the bottom portion be bonded to the
tubular body. (Id.) Fourth, Defendants claim the extrinsic evidence supports Defendants’ proposed
construction, as each of the dictionary definitions mentioned by Plaintiffs makes clear the word
“bottom” has a spatial meaning that connotes the lowest part. (Id. at 17–18.)
Plaintiffs object to Defendants’ construction of the language of claim 8, contending
Defendants view the claim term in isolation, divorced from the context of the claim as a whole.
(ECF No. 205 at 7.) Plaintiffs argue the bottom portion provides a pore through which the solution
reaches the functional space, rather than the inside, of the bottomed tubular holder. (Id.) The
functional space is the space above the bottom portion, where the columnar brush member is

inserted. (Id.) Plaintiffs claim only such a construction is consistent with the language of claim 8,
which expressly recites the solution enters the bottomed tubular holder via the pore “to reach an
end face of the columnar brush member.” (Id.) Moreover, when the specification discusses the
solution entering the bottomed tubular holder, it is also in the context of entering the functional
space. (Id. at 9–10.) Therefore, contrary to Defendants’ assertion, the solution may touch the inside
of the tubular body before it enters the functional space through the pore of the bottom portion to
reach the end face of the brush. (Id. at 7.)
The Court finds the bottom portion does not have to be at the lowest end of the tubular
body of the bottomed tubular holder.
1. The Bottom Portion Defines the Lowest End of the “Inside” of the
Bottomed Tubular Holder
A critical question here is how to define the “inside” of the bottomed tubular holder:
whether the lowest end of the “inside” is the bottom portion or the lowest end of the tubular body.
Despite the absence of an explicit definitional statement in the patent, the specification suggests
the answer is the bottom portion, through a series of consistent references to the scope of the
“inside.” See Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1328 (Fed. Cir. 2002) (holding

a patentee may define a claim term by implication, through the term’s consistent use throughout
the specification). First, the solution in the solution container must come “inside” the bottomed
tubular holder via the pore. (ECF No. 191-2 at 12:58–59.) This suggests only the space above the
bottom portion, where the pore is located, is called the “inside.” Second, the bottom portion is
between the solution container and the columnar brush member. (Id. at 3:15–16.) Since the
columnar brush member is above the bottom portion, the space on the opposite side (i.e., beneath
the bottom portion) should belong to the solution container, rather than the “inside” of the
bottomed tubular holder. Third, the pore controls the amount of a solution moving from the

solution container to the bottomed tubular holder. (Id. at 12:63–66.) The pore can only control the
flow of solution across the bottom portion’s lateral surface, which therefore sets the boundary
between the solution container and the bottomed tubular holder. That means the space above the
bottom portion belongs to the bottomed tubular holder, and the space below belongs to the solution
container.
As a result, Defendants’ argument—if the bottom portion is not at the lowest end of the
tubular body, then the solution could enter the bottom tubular holder without first passing through
the pore—fails, because the solution enters the bottom tubular holder only after passing through
the pore. Therefore, the bottom portion does not have to be at the lowest end of the tubular body.
However, such a construction does not mean, as Defendants assert, the bottom portion can

be bonded anywhere along the tubular body. Inside the bottomed tubular holder is a supporting
member that supports an inserted columnar brush member. (Id. at 3:25–29.) Since the bottom
portion defines the lowest end of the inside of the bottomed tubular holder, the bottom portion
cannot be bonded above the supporting member.
2. The Embodiment in Figure 18 Shows the Bottom Portion Need Not
Be at the Lowest End of the Tubular Body
“A [patent claim] construction that excludes a preferred embodiment is rarely, if ever
correct and would require highly persuasive evidentiary support.” EPOS Techs. Ltd. v. Pegasus
Techs. Ltd., 766 F.3d 1338, 1347 (Fed. Cir. 2014) (citing Anchor Wall Sys., Inc. v. Rockwood
Retaining Walls, Inc., 340 F.3d 1298, 1308 (Fed. Cir. 2003)). “[The Federal Circuit has]
interpreted claims to exclude embodiments of the patented invention where those embodiments
are clearly disclaimed in the specification.” Oatey Co. v. IPS Corp., 514 F.3d 1271, 1277 (Fed.
Cir. 2008). Here, any highly persuasive evidentiary support to exclude the embodiment in Figure
18 is absent. Therefore, a proper construction of “bottom portion” should not ignore the teachings

from Figure 18, where the bottom portion is not at the lowest end of the tubular body. (ECF No.
191-2 at fig. 18.)
Defendants argue the space between the lowest end of the tubular body and the bottom
portion is nominal. (ECF No. 204 at 13.) Defendants state some nominal space will inevitably be
produced after the bottom portion and the tubular body are bonded together, and therefore cannot
change the fact that the bottom portion in Figure 18 is located at the tubular body’s lowest end.
(Id. at 14.) The Court disagrees.
Defendants’ statement could be interpreted in two ways. First, it may mean the “nominal”
space results from an imperfection in the applicator’s manufacturing process. If so, Figure 18
should not contain such a space. A manufacturing error like the “nominal” space may exist in an

actual applicator, but not in its product design. After all, a manufacturing error is something that
is “not in the form intended by, or fails to perform in accordance with” the product design. 16
C.F.R. § 1115.4. A preferred embodiment represents “the actual product design that the inventor
intends to use.” Morgan D. Rosenberg, Essentials of Patent Claim Drafting (2021 Edition) § 1.03
(Matthew Bender). As for the preferred embodiment in Figure 18, Defendants offer no reason why
it would incorporate a manufacturing error that deviates from the bottomed tubular holder’s design.
Therefore, this “nominal” space is unlikely a manufacturing error. Alternatively, Defendants’
statement may mean the “nominal” space is a component of the bottomed tubular holder’s design,
but the space is negligible. However, Defendants only conclusively state the space is “nominal,”
without presenting any relevant evidence. With proper numerical data or standards, a party may
claim a physical element associated with a patent is nominal or negligible. See In re Brandt, 886
F.3d 1171, 1177 (Fed. Cir. 2018) (finding the claimed density range of “less than 6 pounds per
cubic feet” and the prior art range of “between 6lbs/ft3 and 25lbs/ft3” are so mathematically close

that the range difference is “virtually negligible”); Noven Pharms., Inc. v. Mylan Techs. Inc., No.
17-1777, 2018 U.S. Dist. LEXIS 144722, at *5 n.4 (D. Del. Aug. 20, 2018) (calling a flux rate of
0.01 mg/cm2/day or less “nominal”); Jiffy Enters., Inc. v. Sears, Roebuck & Co., 306 F.2d 240,
243 (3d Cir. 1962) (confirming, beyond any reasonable doubt, the differences in weight, mobility
of the hook, or thickness between two hangers are not readily perceptible to the senses and
therefore “negligible”); Glaxo Wellcome, Inc. v. Genentech, Inc., 136 F. Supp. 2d 316, 336 (D.
Del. 2001) (calling a degradation rate at less than 1% of a designated peak value “negligible”).
Defendants provide none of these reasonings. Therefore, the Court does not find the space is so
negligible that the bottom portion in Figure 18 can be characterized as at the lowest end of the
tubular body.

3. The Court Need Not Consider the Meaning of “Bottom” in Other
Components of the Invention
In addition to the bottom portion of the bottomed tubular holder, the word “bottom” is used
to describe other components of the applicator, such as the bottom portion of the solution container,
and the bottom face of the annular flange and the solution container. (ECF No. 190 at 16–18.) But
even if the word “bottom” spatially refers to the lowest part of these other components, it does not
prove the word “bottom” in the disputed term “bottom portion” must have the same meaning.
In claim construction, the same word or term used in different phrases will not necessarily
be interpreted to have the same meaning, because these different phrases may represent different
contexts for the same word or term, thereby attaching different connotations to it. See Epcon Gas
Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1031 (Fed. Cir. 2002) (finding the word
“substantially” used in two contexts had different meanings: the phrase “substantially constant”
denoted language of approximation, while the phrase “substantially below” signified language of
magnitude); In re Translogic Tech., Inc., 504 F.3d 1249, 1258 (Fed. Cir. 2007) (construing the

term “coupled to” differently in “input terminals coupled to receive first and second input
variables” versus “second stage input terminal coupled to the first stage output terminal”); Senior
Techs., Inc. v. R.F. Techs., Inc., 2001 U.S. App. LEXIS 4179, at *23 (Fed. Cir. March 12, 2001)
(finding that the word “enable” implied different ways of enabling the receiving circuit, where the
phrase in claim 6, “to enable the receiving circuit,” existed in a bare form, and the two phrases in
claim 1, “to enable the sensing module” and “to enable the receiving circuit in the sensing module,”
were qualified by additional limitations). After all, “[t]he meaning of a phrase is often greater than
the sum of the individual words.” ADE Corp. v. KLA-Tencor Corp., 252 F. Supp. 2d 40, 58 (D.
Del. 2003).
Here, the word “bottom” is used in different contexts when it describes different

components of the applicator. Each component has its own distinct limitations, which attach
distinct meanings to the word “bottom.” The Court should not simply import the meaning of
“bottom” used in describing other components into the disputed term “bottom portion.”
Accordingly, the Court defines “bottom portion” as “the lateral surface that is bonded to
the tubular body.” The bottom portion is not necessarily at the lowest end of the tubular body.
Since intrinsic evidence has clarified the meaning of “bottom portion,” the Court need not examine
extrinsic evidence such as dictionary definitions.
B. The Meaning of “Tip Portion”
Plaintiffs propose “tip portion” be construed to have its plain and ordinary meaning, i.e.,
“end portion of the columnar brush member” (ECF No. 191 at 27), whereas Defendants propose
“tip portion” be construed to mean the “fan-shaped end of the columnar brush member” (ECF No.
190 at 21).
1. The Tip Portion Is Fan-Shaped

Plaintiffs maintain the tip portion should not be limited to a fan shape. First, the claim
language indicates the tip portion can be any shape, so long as it sits at the end portion of the brush.
(ECF No. 205 at 14.) Claim 8 recites a tip portion without specifying its shape, while claim 9,
which depends on claim 8, further narrows the tip portion to those that are fan-shaped. (Id.) Claims
1 and 10 also refer to the tip portion as fan-shaped. (Id. at 15.) This shows, when the patentee
wants to claim a tip portion of any shape (as in claim 8) or more narrowly only a fan-shaped tip
portion (as in claims 1, 9, and 10), the patentee knows how to do it. (Id.) Under the doctrine of
claim differentiation, the tip portion in independent claim 8 is not limited to a fan shape when its
dependent claim 9 adds a fan shape limitation to the tip portion. (Id. at 14–15.) Second, when the
specification recites the tip portion in the context of claim 8, i.e., the solution flowing through the

columnar brush member, a particular tip shape is not required. (Id. at 16–17.) Even though the
specification, in other instances, recites the term “tip portion” with a fan shape limitation, it does
not indicate the tip portion in all the contexts of the invention should be fan-shaped. (Id.) Third,
achieving the stated objective of the invention, i.e., providing an applicator capable of reducing
irritation on an affected part of a patient, does not require a particular shape of the tip portion. (Id.
at 18.) Rather, the specification attributes the reduced irritation to the softness of the tip portion.
(Id.) Fourth, the problems in the prior art, as described in the specification and which the ’601
patent purports to overcome, are neither caused nor solved by the shape of the tip portion. (Id. at
19.)
However, Defendants argue the fan shape is an essential feature of the tip portion. (ECF
No. 190 at 22.) First, the specification, in multiple instances, describes “the present invention” as
an applicator where the tip portion of the columnar brush member has a fan shape, and specifically
refers to the “fan-shaped columnar brush member tip portion.” (Id. at 22, 24.) In particular, both

of the two examples in the specification discuss a fan-shaped tip portion. (Id. at 24.) Second, in
both the specification and the prosecution history of the ’601 patent, the patentee distinguishes the
claimed invention from the prior art based on a fan-shaped tip portion. (Id. at 27–28.)
Plaintiffs object to Defendants’ understanding of the prosecution history relating to the fan
shape. (ECF No. 205 at 21.) The patentee’s statements distinguishing prior art on the basis of the
fan-shaped tip portion were made in the context of arguing the patentability of claims that
expressly recite the fan shape limitation, and do not apply to claim 8 that does not expressly recite
that very limitation. (Id. at 21–22.) Plaintiffs argue the fan-shape limitation alone did not overcome
any of the prior art and was not critical to allowance of the claims. (Id. at 25.)
The Court finds the tip portion must be fan-shaped.

a. The Claim Language Indicates the Tip Portion Is Fan-Shaped
“A claim must be read in accordance with the precepts of English grammar.” In re Hyatt,
708 F.2d 712, 714 (Fed. Cir. 1983). “[T]he definite article ‘the’ particularizes the subject which it
precedes.” NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1306 (Fed. Cir. 2005) (internal
citations omitted). “It is a word of limitation as opposed to the indefinite or generalizing force of
‘a’ or ‘an.’” Id. In a patent claim, “the introduction of a new element is accomplished through the
use of an indefinite article, not through the use of a definite article.” Tuna Processors, Inc. v. Haw.
Int’l Seafood, Inc., 327 F. App’x 204, 210 (Fed. Cir. 2009). “The definitive article ‘the’ is used to
refer to an element which has been established earlier in a claim.” Id. If that element is not
established earlier in the same claim, the definitive article may refer to an element established in
an earlier claim. See Vidir Mach. Inc. v. United Fixtures Co., 570 F. Supp. 2d 693, 699 (M.D. Pa.
2008) (The patentee concedes “the elongate member” in dependent claims 15 and 16 refers to “an
elongate flexible drive member” identified in independent claim 13); Advanced Tech. Incubator,

Inc. v. Sharp Corp., 2009 U.S. Dist. LEXIS 109173, at *34 (E.D. Tex. June 26, 2009) (finding the
phrase “the continuous layer of transparent conductive material” in independent claim 22 refers to
an element recited in dependent claim 9).
Here, the term “tip portion” in claim 8 is preceded by the definite article “the,” not the
indefinite article “a.” (ECF No. 191-2 at 18:1.) The term does not appear earlier in claim 8. The
only prior recitations of the “tip portion” of the columnar brush member are in claims 1 and 2,
where the tip portion is fan-shaped. (Id. at 16:33–34, 17:11.) Therefore, the term “tip portion” in
claim 8 could only refer to the fan-shaped tip portion in claims 1 and 2.
Though not determinative to the construction of claim 8, the Court notices the term “tip
portion” in claim 9 is preceded by the indefinite article “a,” which suggests it does not refer to “the

tip portion” or “a tip portion” in a preceding claim. As a result, claim differentiation has no
application between claims 8 and 9, because the term “tip portion” in each claim covers a distinct
subject matter. See InterDigital Commc’ns., LLC v. USITC, 690 F.3d 1318, 1325 (Fed. Cir. 2012)
(rejecting the argument that claim differentiation did not apply between two claims because the
disputed term in the two claims covered different subject matters, and finding the term covered the
same subject matter in the two claims). If “a tip portion” in claim 8 is actually meant to refer to “a
tip portion” in claim 1 or “the tip portion” in claim 8, it could be the basis for an indefiniteness
rejection under 35 U.S.C. § 112. See Alcon Research, Ltd. v. Watson Labs., Inc., 2017 U.S. Dist.
LEXIS 21400, at *21 (D. Del. Feb. 15, 2017).
b. The Prosecution History Imposes a Fan Shape Limitation
“[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 Pharms., Inc., 438 F.3d
1123, 1136 (Fed. Cir. 2006). A patentee could do so by clearly characterizing the invention in a

way (i.e., arguing a claim possesses a feature that the prior art does not possess) to try to overcome
a prior art rejection. Id. (internal citations omitted); see also Seachange Int’l, 413 F.3d at 1372–
73; Comput. Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374 (Fed. Cir. 2008). “[B]y
distinguishing the claimed invention over the prior art,” a patentee “is indicating what the claims
do not cover” and “by implication surrendering such protection.” Ecolab, Inc. v. FMC Corp., 569
F.3d 1335, 1342 (Fed. Cir. 2009) (citing Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1304 (Fed.
Cir. 1997)).
“A disavowal of scope as to the general nature of an invention limits all claims where the
statements made in prosecution history are not associated with particular claim language.” iLight
Techs., Inc. v. Fallon Luminous Prods. Corp., 380 F. App’x 978, 980 (Fed. Cir. 2010) (citing

Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307, 1315–16 (Fed. Cir. 2007)). “Only disclaimers
that distinguish the prior art by focusing on a particular claim limitation are not directed to the
invention as a whole.” Id. (citing Saunders Grp., , 492 F.3d at 1333). “In determining whether a
clear and unambiguous disclaimer attaches to particular claim language, it is important to consider
the statements made by the applicant both in the context of the entire prosecution history and the
then-pending claims.” MIT v. Shire Pharms., Inc., 839 F.3d 1111, 1120 (Fed. Cir. 2016).
During the prosecution of the ’601 patent, the patentee on three occasions argued the
applicator possessed a fan-shaped tip portion that the prior art did not possess. The first occasion
involved the originally filed claim 1, which recited an applicator with “a tip portion of the columnar
brush member outside the solution container [that] has a fan shape.” (ECF No. 190-3 at 3.) The
examiner rejected the claim for obviousness over U.S. Patent No. 6,073,634 (“Gueret”) because
Gueret taught all the limitations of the claimed applicator, including a fan-shaped tip portion of
the columnar brush member. (Id. at 10–11.) In response, the patentee countered the tip portion in

Gueret was only “a convex shape,” rather than “a fan shape extending in a perpendicular lateral
direction against a pillar axial lengthwise direction.” (Id. at 22.) The examiner maintained the
rejection, arguing Gueret did teach the shape of a fan. (Id. at 39.) The second occasion involved
the amended claim 1 submitted by the patentee. The patentee made amendments (unrelated to the
fan shape) to claim 1 (Id. at 69–70), after an obviousness rejection based on U.S. Publication No.
2009/0279937 (“Peck”) which the examiner stated had a fan-shaped tip portion (Id. at 58). The
patentee argued the tip portion in Peck did not meet the recitation of a fan shape with the direction
and thickness features3 identified in then claim 1. (Id. at 73–74.) But the examiner again rejected
and maintained Peck possessed a fan-shaped tip portion with the above direction and thickness
features. (Id. at 83.) The third occasion came after the patentee canceled all then pending claims

and added new claims. (Id. at 131.) All the newly added claims include a fan shape limitation for
the tip portion, except for claim 19 which was ultimately issued as claim 8 in the ’601 patent. (Id.
at 131–37.) In explaining the newly added claims are not obvious over Peck, the patentee
contended the columnar brush member in Peck was “tapered or pseudo-tapered,” and presented a

3 “a fan shape extending in a perpendicular lateral direction against a pillar axial lengthwise
direction, and a thickness of the fan-shaped tip portion of the columnar brush member decreases
in a perpendicular lengthwise direction against the pillar axial lengthwise direction toward the tip
portion of the columnar brush member” (ECF No. 190-3 at 69.)
new ground4 to argue the tip portion in Peck did not have a fan shape with the direction and
thickness features5 as identified in then claim 12. (Id. at 142–43.)
Each of the above disavowals counts as a statement by the patentee on the shape of the “tip
portion” of the columnar brush member. The Court need not determine whether these disavowals

are directed to the invention as a whole or a particular claim term. If these disavowals are directed
to the entire invention, then they will apply to all the patent claims, including claim 8. If not, they
will still apply to claim 8 anyway. After all, claim 8 contains the very claim term “tip portion” that
these disavowals focus on. Therefore, the prosecution history limits the tip portion in claim 8 to a
fan shape.
c. The Specification Restricts the Tip Portion to a Fan Shape
The patent claims must be construed in view of the specification, but not everything in the
specification will be read into the claims. Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313,
1326 (Fed. Cir. 2002). Nevertheless, the specification may limit the scope of the claims in two
ways: lexicography and disavowal. Hill-Rom Servs. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed.

Cir. 2014). “The standards for finding lexicography and disavowal are exacting.” GE Lighting
Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2014). “[A]n inventor may choose to
be his own lexicographer if he defines the specific terms used to describe the invention ‘with
reasonable clarity, deliberateness, and precision.’” Teleflex, 299 F.3d at 1325 (citing In re Paulsen,

4 Peck only provides a 2-dimensional view for its tip portion (ECF No. 190-3 at 143), and therefore
cannot describe certain 3-dimensional features of the tip portion as stated in the newly added
claims.

5 “a fan shape extending in a perpendicular lateral direction against a pillar axial lengthwise
direction, and a thickness of the fan-shaped tip portion of the columnar brush member decreases
in a perpendicular lengthwise direction against the pillar axial lengthwise direction toward the tip
portion of the columnar brush member” (ECF No. 190-3 at 131.)
30 F.3d 1475, 1480, 31 U.S.P.Q.2D (BNA) 1671, 1674 (Fed. Cir. 1994)). Alternatively, the
patentee may include “in the specification expressions of manifest exclusion or restriction,
representing a clear disavowal of claim scope.” Id. (citing SciMed Life Sys., 242 F.3d at 1344).
An explicit statement of definition or disavowal is not necessary. Trs. of Columbia Univ.

v. Symantec Corp., 811 F.3d 1359, 1364 (Fed. Cir. 2016). “[T]he specification may define claim
terms by implication such that the meaning may be found in or ascertained by a reading of the
patent documents.” Id. (internal citations omitted). For example, “an inventor may disavow claims
lacking a particular feature when the specification describes ‘the present invention’ as having that
feature.” Poly-America, L.P. v. API Indus., Inc., 839 F.3d 1131, 1136 (Fed. Cir. 2016) (internal
citations omitted). Also, “[w]hen a patentee ‘describes the features of “the present invention” as a
whole,’ he alerts the reader that ‘this description limits the scope of the invention.’” Pacing Techs.,
LLC v. Garmin Int’l, Inc., 778 F.3d 1021, 1025 (Fed. Cir. 2015) (internal citations omitted). “While
clear language characterizing ‘the present invention’ may limit the ordinary meaning of claim
terms, such language must be read in context of the entire specification and the prosecution

history.” Rambus Inc. v. Infineon Techs. AG, 318 F.3d 1081, 1094 (Fed. Cir. 2003) (refusing to
limit a disputed term when most references to the term in the specification do not contain the
purported limitation as recited in a single paragraph describing “the present invention”).
The Court finds the specification of the ’601 patent contains clear statements of disavowal
which indicate the tip portion is fan-shaped. First, the first paragraph of the “summary of the
invention” explains:
the present invention provides an applicator, comprising a solution
container having an opening and a columnar brush member formed
by bundling synthetic fibers in a columnar shape, wherein the
columnar brush member disposed at the opening of the solution
container, a tip portion of the columnar brush member outside the
solution container has a fan shape extending in a perpendicular
lateral direction against a pillar axial lengthwise direction, and a
thickness of the fan-shaped tip portion of the columnar brush
member decreases in a perpendicular lengthwise direction against
the pillar axial lengthwise direction toward the tip portion of the
columnar brush member.
(ECF 191-2 at 2:36–49.) “When a patent thus describes the features of the ‘present invention’ as a
whole, this description limits the scope of the invention.” Regents of the Univ. of Minn. v. AGA
Med. Corp., 717 F.3d 929, 936 (Fed. Cir. 2013) (finding a similar first paragraph6 of the summary
of the invention limits the scope of the invention) (internal citations and quotations omitted).
Second, “advantageous effect of the invention” states:
[t]he tip portion of the columnar brush member used in the present
invention outside the solution container has a fan shape, and a
thickness of the fan-shaped tip portion of the columnar brush
member decreases toward the tip of the columnar brush member.
(ECF 191-2 at 3:45–49.) The above two statements are not isolated, as the remainder of the
specification is replete with references of a fan-shaped tip portion. (See, e.g., id. at 2:29–30, 3:50–
53, 7:63–65, 8:15–16, 9:12.) The specification never describes a tip portion that adopts a different
shape. Therefore, the specification, read as a whole, imposes a fan-shape limitation on the disputed
term “tip portion,” including that in claim 8.
In sum, the ’601 patent’s claim language, prosecution history, and specification all indicate
the tip portion of the columnar brush member must be fan-shaped. The Court need not refer to the
doctrine of claim differentiation, which is “not a hard and fast rule and will be overcome by a
contrary construction dictated by the written description or prosecution history.” Regents of the

6 “The present invention provides a simple, reliable device for effectively occluding a septal defect.
The instant closure device includes first and second occluding disks which are attached to one
another. . . . A central portion of the membrane of each disk is affixed to a corresponding portion
of the membrane of the other disk, thereby attaching the two disks directly to one another at their
centers. The affixed central portion of the two membranes define[] a central ‘conjoint disk’ of the
device . . . .” Regents of the Univ. of Minn., 717 F.3d at 936.
Univ. of Cal. v. DakoCytomation Cal., Inc., 517 F.3d 1364, 1375 (Fed. Cir. 2008) (citing
Seachange Int’l, 413 F.3d at 1369).
2. The Tip Portion Is the Fan-Shaped End Opposite to the End Face
Both parties agree the tip portion is located at an end of the columnar brush member. (ECF

No. 190 at 21.) However, Defendants contend “tip portion” should be more narrowly construed
than a generic “end portion.” (ECF No. 204 at 22.) Defendants argue “tip portion” can only be the
fan-shaped end portion that is opposite to the end face. (ECF No. 190 at 22.) The Court agrees.
The columnar brush member has two ends, which are separately termed as “tip portion”
and “end face” in claim 8. (ECF No. 191-2 at 17:67–18:1.) The two ends are different functionally.
The plain language of claim 8 indicates a solution that “enters the bottomed tubular holder” will
first reach “an end face of the columnar brush member” and then “to the tip portion opposite to the
end face of the columnar brush member by capillarity.” (Id. at 17:60–18:2.) Besides, the two ends
are different structurally. Only the tip portion is fan-shaped; nowhere in the ’601 patent or its
prosecution history suggests the end face may be fan-shaped. Therefore, the tip portion must be

the fan-shaped end of the columnar brush member that is opposite to the end face.
Accordingly, the Court defines “bottom portion” as “the lateral surface that is bonded to
the tubular body,” and “tip portion” as “the fan-shaped end of the columnar brush member.”
IV. CONCLUSION
For the reasons set forth above, this Court defines the disputed claim terms “bottom
portion” to mean “the lateral surface that is bonded to the tubular body,” and “tip portion” to mean
“the fan-shaped end of the columnar brush member.” An appropriate order follows.
Date: January 11, 2020 /s/ Brian R. Martinotti___________
HON. BRIAN R. MARTINOTTI
UNITED STATES DISTRICT JUDGE

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10269740. Public record. Not legal advice.