COPAN ITALIA SPA et al v. PURITAN MEDICAL PRODUCTS COMPANY LLC et al

Filing 145

CLAIM CONSTRUCTION ORDER By JUDGE JON D. LEVY. (tcs)

UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
COPAN ITALIA S.P.A., et al.,

)
)
Plaintiffs,
)
)
v.
) 1:18-cv-00218-JDL
)
PURITAN MEDICAL PRODUCTS )
COMPANY LLC, et al.,
)
)
Defendants.
)
CLAIM CONSTRUCTION ORDER
Copan Italia S.p.A. and Copan Diagnostics, Inc. (collectively, “Copan”) bring
this patent infringement suit against Puritan Medical Products Company LLC,
Puritan Diagnostics LLC, Hardwood Products Company LP, and Hardwood Products
Company LLC (collectively, “Puritan”). Because the parties request construction of
the preambles and thirteen claim terms in the patents-in-suit, see ECF No. 129 at
Page ID 3348−49, the Court held a Markman claim construction hearing on June 26,
2019. See generally Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).
I. FACTUAL BACKGROUND
The five patents-in-suit—Patent No. 8,114,027 (“the ‘027 Patent”), Patent No.
8,317,728 (“the ‘728 Patent”), Patent No. 8,979,784 (“the ‘784 Patent”), Patent No.
9,011,358 (“the ‘358 Patent”), and Patent No. 9,173,779 (“the ‘779 Patent”)—relate to
a flocked swab device and a method for using flocked swabs to collect, transport, and

release biological specimen samples for analysis. All five patents are related, as they
all descend from the same patent application and share a common specification.1
The industry predecessor of Copan’s flocked swab was a fiber swab similar in
construction to a Q-tip: a small rod with a wad of fibers wrapped around the tip.
Copan asserts that it identified several problems with using fiber swabs to collect
biological specimens, including that “on average only about 40% of the liquid
specimen collected” could be recovered from the fiber swab for analysis. ‘027 Patent,
ECF No. 72-1 at Page ID 768. In response to these problems, Copan developed its
flocked swab. Instead of wrapping a wad of fibers around the tip of a rod, Copan used
a process known as electrostatic flocking to cover the tip of the rod with fibers. Id.
Electrostatic flocking consists of placing a rod with adhesive on the tip in an
electrostatic field and charging both the rod and the fibers, causing the fibers to fly
towards the rod and adhere to the tip. Copan claims that a flocked swab “is capable
of releasing about 90% of the absorbed specimen” for analysis, in contrast to the fiber
swab’s 40% average release rate. Id. at Page ID 769.
II. LEGAL ANALYSIS
A.

Claim Construction Standards
“[T]he 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).
The construction of patent claims is a question of law which is “exclusively within the
province of the court.” Markman, 517 U.S. at 372, 384. “In determining the proper

1

A specification is a written description of the invention claimed by a patent. See 35 U.S.C.A. § 112 (West 2019);
37 C.F.R. §§ 1.71, 1.77 (2018).
2

construction of a claim,” a court “look[s] first to the intrinsic evidence of record, i.e.,
the patent itself, including the claims, the specification and, if in evidence, the
prosecution history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
Cir. 1996). Courts may also consult extrinsic evidence, “which consists of all evidence
external to the patent and prosecution history, including expert and inventor
testimony, dictionaries, and learned treatises.” Phillips, 415 F.3d at 1317 (quotation
marks omitted). But “such evidence is generally of less significance than the intrinsic
record.” Endo Pharm. Inc. v. Actavis LLC, 922 F.3d 1365, 1371 (Fed. Cir. 2019)
(quoting Wi-LAN, Inc. v. Apple Inc., 811 F.3d 455, 462 (Fed. Cir. 2016)).
“[C]laim construction must begin with the words of the claims themselves.” Id.
at 1370 (quoting Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1301
(Fed. Cir. 2006)). The terms within a claim are generally given their “ordinary and
customary meaning,” 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. “[T]he person of
ordinary skill in the art is deemed to read the claim term not only in the context of
the particular claim in which the disputed term appears, but in the context of the
entire patent, including the specification.” Id. Additionally, where, as here, “multiple
patents derive from the same parent application and share many common terms, [a
court] must interpret the claims consistently across all asserted patents.” Samsung
Elecs. Co. v. Elm 3DS Innovations, LLC, 925 F.3d 1373, 1378 (Fed. Cir. 2019)
(quotation marks omitted).

3

Though the general rule is that claim terms are given their ordinary meaning,
courts may construe a claim term more narrowly than its ordinary meaning in two
circumstances: “1) when a patentee sets out a definition and acts as [its] own
lexicographer, or 2) when the patentee disavows the full scope of a claim term either
in the specification or during prosecution.” Aventis Pharma S.A. v. Hospira, Inc., 675
F.3d 1324, 1330 (Fed. Cir. 2012). A patentee acts as its own lexicographer if it
“‘clearly set[s] forth a definition of the disputed claim term’ other than [the term’s]
plain and ordinary meaning.” Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d
1362, 1365 (Fed. Cir. 2012) (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d
1359, 1366 (Fed. Cir. 2002)). A patentee disavows the full scope of a claim term if the
specification or prosecution history “makes clear that the invention does not include
a particular feature,” even if the language of the claims otherwise “might be
considered broad enough to encompass the feature in question.” Id. at 1366 (quoting
SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341
(Fed. Cir. 2001)).
B.

Analysis
1. Defining a Person of Ordinary Skill in the Art
As discussed above, 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. The parties dispute
how a “person of ordinary skill in the art” should be defined in the context of the five
patents-in-suit. Copan argues that the patents-in-suit involve two pertinent arts:
clinical microbiology, and flocked fiber and textiles arts. Copan asserts that a person
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of ordinary skill in clinical microbiology has at least a bachelor’s degree in biology or
comparable science, as well as two years of practical experience in biological specimen
collection and analysis. Copan further asserts that a person of ordinary skill in the
flocked fiber and textiles arts has either four years of experience in fiber science or a
bachelor’s degree in chemistry or physics and two years of experience related to fiber
science.
Puritan proposes a broader, simpler definition, asserting that the pertinent art
is any field that would give an artisan general knowledge of flocking techniques and
capillarity. Puritan contends that a person of ordinary skill in such a field has either
a graduate degree in electrical, mechanical, or material engineering, or an
undergraduate degree in the same and experience in electrostatic flocking.
Although claim construction depends upon the understanding of a person of
ordinary skill in the art, the scope of the pertinent art and the exact level of skill that
such a person should possess are factual questions. See Graham v. John Deere Co. of
Kansas City, 383 U.S. 1, 17 (1966) (citing 35 U.S.C. § 103). I decline to resolve the
parties’ dispute regarding the meaning of the term “a person of ordinary skill in the
art” at this juncture, absent a more fulsome evidentiary record. Moreover, I conclude
that under either Copan’s or Puritan’s proposed definition of the term, a person of
ordinary skill in the art would understand the disputed terms of the patents-in-suit
in the same way. Thus, I do not decide that issue at this stage of the proceeding.
2. The Preambles
“A claim typically contains three parts: the preamble, the transition, and the
body.” Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 770 (Fed. Cir.
5

2018) (quoting 3 Chisum on Patents § 8.06 (2018)). Depending on “the facts of each
case in light of the claim as a whole and the invention described in the patent,” a
preamble term may or may not be construed as limiting the scope of the claim. Am.
Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1358 (Fed. Cir. 2010) (quoting Storage
Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)). For example, a
preamble may limit the invention “if it recites essential structure or steps,” or if the
patent applicant clearly relies on it during prosecution in order to distinguish the
claimed invention from prior art. Acceleration Bay, 908 F.3d at 770 (quotation marks
omitted); Marrin v. Griffin, 599 F.3d 1290, 1294 (Fed. Cir. 2010). By contrast, a
preamble “is not limiting where a patentee defines a structurally complete invention
in the claim body and uses the preamble only to state a purpose or intended use for
the invention.”

Acceleration Bay, 908 F.3d at 770 (quotation marks omitted).

“Generally, the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell
Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002).
Here, Copan argues that the preambles for the patents-in-suit are limiting
because the patent applicant, Daniele Triva, relied on them during prosecution to
distinguish Copan’s flocked swab from prior art. To support this argument, Copan
points out that Triva explained to the patent examiner that collecting biological
samples was part of the intended invention and further notes that the preambles
contain language to that effect. E.g., ‘027 Patent, ECF No. 72-1 at Page ID 769
(introducing the invention as a “method for collecting biological specimen to be
analyzed”); ‘784 Patent, ECF No. 72-3 at Page ID 788 (introducing the invention as
a “biological specimen collection swab”). Puritan counters that the preambles merely
6

recite an intended use and do not limit the scope of the claims, likewise turning to
the prosecution history for support.
I conclude that the preambles are not limiting for two reasons. First, although
Triva did argue during prosecution that the preamble distinguished the invention
from prior art, see ECF No. 72-8 at Page ID 908−09, the patent examiner disagreed
because the prior art that Triva sought to overcome could also be used for collecting
biological specimens. See ECF No. 79-7 at Page ID 2550; see also Catalina Mktg.
Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 810 (Fed. Cir. 2002) (affirming the
district court’s holding that preamble language did not limit a claim where the patent
examiner considered the preamble “insignificant for patentability”).
Second, the bodies of the claims in each patent describe a complete invention,
and I agree with the patent examiner’s finding that the preambles do not structurally
limit the invention but merely state its intended use. See ECF No. 79-7 at Page ID
2550. For example, claim 1 of the ‘027 Patent states, in relevant part:
A method for collecting biological specimen to be analyzed, with a swab
comprising a rod terminating in a tip, a layer of fibers of uniform
thickness, covering the tip and disposed in an ordered arrangement and
perpendicular to the surface of the tip by flocking, . . . the method
comprising the steps of:
collecting a liquid specimen to be analyzed by absorbing a
quantity between 40 µl and 100 µl of liquid specimen in said layer
of fibers by capillarity effect;
storing and transporting said quantity of specimen in said layer
of fibers; and
releasing a quantity of said specimen to be analyzed from said
layer of fibers.
‘027 Patent, ECF No. 72-1 at Page ID 769−70. The preamble “collecting biological
specimen to be analyzed” does not add an essential step to the method—a person of
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ordinary skill in the art would understand how to use the swab solely from the
language of the claim. Arguably, the claim’s description of the method as “collecting
a liquid specimen to be analyzed” is more specific than the preamble language. Id. at
770.
The apparatus claims similarly describe a structurally complete invention. For
example, claim 1 of the ‘784 Patent states:
A biological specimen collection swab comprising:
a plastic rod terminating in a tip; and
a layer of fibers disposed on a surface of said tip by flocking, with
a flocking technique in which the fibers were deposited, in an
electrostatic field, in an ordered manner perpendicularly to the
surface of the tip of the swab rod, the layer of fibers having a
thickness from 0.6 to 3 mm and a fiber count of 1.7 to 3.3 Dtex, in
which said layer of fibers is configured to be capable of absorbing
a quantity of 40 µl to 100 µl of specimen in said layer of fibers on
the tip of the rod.
‘784 Patent, ECF No. 72-3 at Page ID 788. The preamble’s “biological specimen
collection swab” does not recite an essential structure. The word “swab,” which is the
only part of the preamble that describes the physical structure of the invention, also
appears in the body of the claim. The body of the claim also includes detailed
structural parameters for the invention. Thus, a person of ordinary skill in the art
would understand the structure of the invention without the use of the phrase
“biological specimen collection swab.”
For the foregoing reasons, I conclude that the preambles merely recite an
intended use and do not limit the scope of the asserted claims.

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3. Agreed-Upon Claim Terms
a. “tip”
The parties agree that this term should be given its plain and ordinary
meaning, which is: “The flocked end of a swab.”
b. “swab”
The parties agree that this term should be given its plain and ordinary
meaning, which is: “A stick or wire with a small piece of absorbent material attached
to the end.”
4. Claim Terms that Puritan Asserts are Indefinite
Puritan argues that the patents-in-suit do not provide sufficient guidance as
to the meaning of seven claim terms, and thus that the claims in which those terms
appear are invalid because they are indefinite. “The Patent Act requires that a patent
specification ‘conclude with one or more claims particularly pointing out and
distinctly claiming the subject matter which the applicant regards as [the]
invention.’” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014)
(emphasis omitted) (quoting 35 U.S.C. § 112, ¶ 2 (2006 ed.)).2 This ensures that the
patent affords clear notice of what is claimed, thereby apprising the public of what is
still open to them and avoiding the “zone of uncertainty.” Markman, 517 U.S. at 373,
390 (quotation marks omitted).

A patent claim does not satisfy this statutory

requirement, and thus is indefinite, if its language, when read in light of the

2

When the America Invents Act, Pub. L. No. 112-29, took effect on September 16, 2012, section 112 was divided
into subsections and paragraph 2 became subsection (b). The applications resulting in the patents at issue in this
case were filed before the AIA took effect, but the substantive content of section 112 as it pertains to the
indefiniteness analysis in this case did not change. Compare 35 U.S.C.A. § 112, ¶ 2 (West through Sept. 15, 2012),
with 35 U.S.C.A. § 112 (West 2019).
9

specification and prosecution history, “fail[s] to inform, with reasonable certainty,
those skilled in the art about the scope of the invention.” Nautilus, 572 U.S. at 901.
“[T]he dispositive question . . . is whether the claims, not particular claim terms” are
indefinite. Cox Commc’ns, Inc. v. Sprint Commc’n Co., 838 F.3d 1224, 1231 (Fed. Cir.
2016).
Patents are presumptively valid, so the burden of establishing that a patent
claim is invalid for indefiniteness rests on the party asserting such invalidity. See
Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 97, 102 (2011). “Any fact critical to a
holding on indefiniteness must be proven by the challenger by clear and convincing
evidence.” Cox Commc’ns., Inc., 838 F.3d at 1228 (quotation marks and alteration
omitted).
a. “ordered arrangement” / “ordered manner”
The term “ordered arrangement” appears in the sole independent claim of the
‘027 Patent and in a dependent claim of the ‘728 Patent.3 See ‘027 Patent, Claim 1,
ECF No. 72-1 at Page ID 769; ‘728 Patent, Claim 13, ECF No. 72-2 at Page ID 779.
Copan also used the phrase “ordered arrangement” during prosecution in an attempt
to distinguish its flocking method from prior art. See ECF No. 73-8 at Page ID
1383−86. “Ordered manner” appears in independent claims in the ‘784 Patent, the
‘358 Patent, and the ‘779 Patent. See ‘784 Patent, Claim 1, ECF No. 72-3 at Page ID
788; ‘358 Patent, Claims 1, 14, 23, and 24, ECF No. 72-4 at Page ID 798; ‘779 Patent,

An independent claim stands alone, whereas a dependent claim refers to “a claim previously set forth and then
specif[ies] a further limitation on the subject matter claimed.” 35 U.S.C.A. § 112(d) (West 2019). The construction
of an independent claim is incorporated by reference into all of its dependent claims. Id. By contrast, dependent
claims include additional limitations that are usually not incorporated into the construction of the independent
claim from which they flow. GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1310 (Fed. Cir. 2014).
10
3

Claims 1, 13, ECF No. 72-5 at Page ID 808. A representative example of the term as
it appears in an independent claim is: “a flocking technique in which the fibers were
deposited, in an electrostatic field, in an ordered manner perpendicularly to the
surface of the tip of the rod . . . .” ‘779 Patent, Claim 1, ECF No. 72-5 at Page ID 808.
“Ordered manner” also appears in the specification: “The flocking technique is
preferably of the type conducted in an electrostatic field which deposits the fibres in
an ordered manner, perpendicular to the surface of the tip of the swab rod . . . .” ‘728
Patent, ECF No. 72-2 at Page ID 778.
Puritan argues that “ordered arrangement” and “ordered manner” are
indefinite because they are vague and subjective descriptors that do not clearly
indicate the scope of the claims in which they appear, and that neither the
prosecution history nor the specification provide any guidance as to the meaning of
the terms.

However, the terms “ordered,” “arrangement,” and “manner” are all

common words that are readily understood, not only by a person of ordinary skill in
the art but also by a layperson. The adjective “ordered” indicates that the noun it
modifies “is dictated by some logic, rule, or governing principle.” Netflix, Inc. v.
Blockbuster, Inc., 477 F. Supp. 2d 1063, 1071 (N.D. Cal. 2007).
The intrinsic evidence supports this construction. Viewed in the context of the
patents-in-suit, “ordered arrangement” and “ordered manner” are used to instruct
how to deposit the fibers onto the surface of the swab. The independent claims that
include “ordered manner” all instruct that the flocking technique involves depositing
the fibers “in an ordered manner perpendicularly to the surface of the tip of the rod.”
E.g., ‘779 Patent, Claim 1, ECF No. 72-5 at Page ID 808. The dependent claim where
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“ordered arrangement” appears similarly instructs that the layer of fibers is “disposed
on said tip in an ordered arrangement by flocking.” ‘728 Patent, Claim 13, ECF No.
72-2 at Page ID 779. Additionally, Triva argued during prosecution that Copan’s
flocked swab was distinct from prior art because prior art “advocates avoiding the
adjustment of the flock direction. Thus, flocking as such cannot provide an ordered
arrangement of the fibers normal to the target substrate unless the fibers are
intentionally oriented to such purpose. Such ordered arrangement of normal fibers
does not flow naturally from the flocking process.” ECF No. 73-8 at Page ID 1386. In
the context of the patents, it is clear that “normal” is synonymous with
“perpendicular.” See also Streamfeeder, LLC v. Sure-Feed Sys., Inc., 175 F.3d 974,
980 (Fed. Cir. 1999) (treating “normal” as synonymous with “perpendicular to a
surface”). Based on the patents and the prosecution history, a person of ordinary skill
in the art would understand “ordered arrangement” and “ordered manner” to mean
that the fibers need to be intentionally arranged so that they are perpendicular to the
rod’s tip when they are flying toward it during the flocking process.
Puritan contends that this construction violates the doctrine of claim
differentiation, which presumes that “each claim in a patent has a different scope,”
Versa Corp. v. Ag-Bag Int’l Ltd., 392 F.3d 1325, 1330 (Fed. Cir. 2004), because it
makes “ordered arrangement” and “ordered manner” redundant with other
descriptors in the patents, such as “in an electrostatic field,” “perpendicular,” and
“substantially parallel.” ECF No. 77 at Page ID 2187. But the plain and ordinary
meaning of each of these descriptors is distinct from the plain and ordinary meaning
of “ordered.” Viewed in the context of the patent as a whole, these descriptors modify
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the term “ordered,” providing additional guidance as to how the fibers should be
arranged during the flocking process. As such, the doctrine of claim differentiation
does not preclude construing “ordered” according to its plain and ordinary meaning.
Thus, Puritan has not met its burden of establishing that the claims containing
the terms “ordered arrangement” and “ordered manner” are indefinite, and I conclude
that those terms should be given their plain and ordinary meaning.
b. “a thickness between 0.6 and 3 mm” & variants
Puritan argues that this term is indefinite because “there are at least four
different ways to measure the thickness of a layer of fibers,” the intrinsic record does
not provide guidance as to which method to use, and the different methods result in
“materially different measurements.” ECF No. 77 at Page ID 2194. However, during
prosecution, Copan clarified that “thickness” refers to the layer of fibers and not the
thickness of the individual fibers. ECF No. 78 at Page ID 2283. The specification
further indicates that the length of the fibers determines the thickness of the layer,
such that both the length of the fibers and the thickness of the layer are to measure
between 0.6 and 3 millimeters. See, e.g., ‘027 Patent, ECF No. 72-1 at Page ID 769
(explaining that “the fiber lengths can be from 0.6 mm to 3 mm, which is the thickness
of the layer”). Neither party suggests that there is more than one way to measure
the length of a fiber. Thus, the specification and the prosecution history provide
enough guidance about how to measure thickness to resolve the ambiguity that
Puritan has identified. This is not a situation where “[c]ompetitors trying to practice
the invention or to design around it would be unable to discern the bounds of the
invention.” Honeywell Int’l, Inc. v. Int’l Trade Comm’n, 341 F.3d 1332, 1341 (Fed.
13

Cir. 2003) (finding a patent claim indefinite where the patentee failed to specify a
method because a person of ordinary skill in the art would not be able to discern the
bounds of the invention). Accordingly, I conclude that the claims containing this term
are not indefinite and accord the term its plain and ordinary meaning.
c. “fibers define capillaries in said layer of fibers, conferring
hydrophilic properties by capillarity to the layer of fibers”
& variants
Puritan contends that the phrase “hydrophilic . . . by capillarity” is indefinite.
Puritan concedes that both “hydrophilic” and “capillarity” have well-understood
technical meanings. ECF No. 77 at Page ID 2198. “Hydrophilic” means “[h]aving an
affinity for, attracting, adsorbing, or absorbing water.” Id. “Capillarity” or “capillary
action” means “[t]he action by which the surface of a liquid where it contacts a solid
is elevated or depressed because of the relative attraction of the molecules of the
liquid for each other and for those of the solid.” Id.
“Properly viewed, the ‘ordinary meaning’ of a claim term is its meaning to the
ordinary artisan after reading the entire patent.” Phillips, 415 F.3d at 1321. Here,
the ordinary meaning of the words comprising this claim term are not in dispute. I
conclude that a person of ordinary skill in the art, after reading the whole patent,
would accordingly understand the phrase “hydrophilic by capillarity” to mean that
the space between the fibers creates an additional hydrophilic effect by drawing liquid
into the layer of fibers by capillary action.
Puritan asserts that the phrase “hydrophilic . . . by capillarity” is indefinite
because that phrase has no established meaning and did not exist in the art at the
time of the invention. ECF No. 77 at Page ID 2200. But to accept Puritan’s argument
14

would ignore the purpose of patent protection. If patents were limited to inventions
containing only previously known components or effects, the goal of promoting new
and useful inventions through the patent system would be impaired. Thus, Puritan
has not demonstrated that a person of ordinary skill in the art, after reviewing the
intrinsic record, would not understand the scope of the claims containing the disputed
“hydrophilic by capillarity” term. I therefore conclude that the claims where this term
appears are not indefinite and construe the term according to its plain and ordinary
meaning.
d. “about 90%”
Copan argues that the term “about 90%” has a clear meaning because “about”
is generally understood to mean “approximately” or “reasonably close to” and that the
term should be construed accordingly. ECF No. 78 at Page ID 2289. Puritan responds
that the term is indefinite, emphasizing that the United States Patent and
Trademark Office informed Copan that “about 90%” was indefinite in two separate
patent applications. However, a district court construing terms in patents that have
already issued applies a different standard than the Patent and Trademark Office
applies during patent examination. “During examination, claims are to be given their
broadest reasonable interpretation consistent with the specification . . . .” In re
Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012) (internal alterations and quotation
marks omitted). Thus, the Patent and Trademark Office’s statements imply that it
found the broadest reasonable interpretation of “about 90%” indefinite. By contrast,
courts construe claims in issued patents according to “the plain meaning of the claim
terms themselves in light of the intrinsic record,” not according to the broadest
15

reasonable interpretation of the claim terms. In re CSB-Sys. Int’l, Inc., 832 F.3d 1335,
1340 (Fed. Cir. 2016). Thus, the Patent and Trademark Office’s statements during
prosecution are not determinative here.
“[A] patentee need not define his invention with mathematical precision in
order to comply with the definiteness requirement.” Invitrogen Corp. v. Biocrest Mfg.,
L.P., 424 F.3d 1374, 1384 (Fed. Cir. 2005). “Claim language employing terms of
degree has long been found definite where it provide[s] enough certainty to one of
skill in the art when read in the context of the invention.” Interval Licensing LLC v.
AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014). By contrast, a claim is indefinite
when the meaning of a term is “purely subjective.” Id. Here, the patent employs the
term of degree “about 90%” to indicate how much of the collected specimen can be
recovered from the fibers for analysis. The word “about” in this context is not a purely
subjective term but rather modifies “90%” and, therefore, provides an objective
boundary by establishing that a swab that releases “approximately 90%” of the
specimen absorbed would be infringing. See Merck & Co., Inc. v. Teva Pharm. USA,
Inc., 395 F.3d 1364, 1369−72 (Fed. Cir. 2005) (according the word “about” its plain
and ordinary meaning of “approximately”).
I conclude that Puritan has not demonstrated by clear and convincing evidence
that “about 90%” is indefinite, and I construe “about 90%” to have its plain and
ordinary meaning of “approximately 90%.”

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e. “rod is suitable for human clinical collection” and its variant,
“a clinical swab, configured for human clinical collection”
The phrase “suitable for human clinical collection” appears only in dependent
claims in the ‘784 Patent and the ‘358 Patent, where the phrase modifies the word
“rod,” and the ‘779 Patent, where the phrase modifies the word “swab.”4 ‘784 Patent,
Claim 4, ECF No. 72-3 at Page ID 788; ‘358 Patent, Claim 6, ECF No. 72-4 at Page
ID 798; ‘779 Patent, Claim 9, ECF No. 72-5 at Page ID 808. Puritan argues that this
term is indefinite because the intrinsic record provides no guidance as to the scope of
these terms and, consequently, there are no objective boundaries that would allow a
person of ordinary skill in the art to determine whether a swab or method infringes
the patents-in-suit.
However, viewed as a whole, the patents provide ample guidance as to what
makes a swab suitable for human clinical collection. For example, the specification
of the ‘779 Patent states that a rod with a truncated, unprotected end would make
specimen collection difficult for clinicians and uncomfortable for patients.

The

specification goes on to explain the drawbacks of the flocked swab’s industry
predecessor, including that a swab with “maximum protective effect” for the patient
would have a thick wad of fiber on the end, which would cause liquid to become
trapped instead of releasing easily. ECF No. 72-5 at Page ID 806. By comparison,
one of the asserted advantages of the flocked swab is that “the required rounded
shape of the swab, i.e. free of edges, no longer has to depend on the mass of fibre itself

4 The parties have agreed to drop claim 24 of the ‘779 Patent, which includes the phrase “during a human
clinical collection procedure.” ECF No. 72-5 at Page ID 808. Therefore, only claim 9 of the ‘779 Patent is in
dispute here.
17

but on the tip of the rod, which can therefore be preferably shaped into a round form
. . . .” Id. at Page ID 807. The specification also provides more detailed examples of
characteristics that may be required for specific kinds of human clinical collection—
like ocular or urethral collection, where “swabs of the greatest possible thinness are
required”—but notes that the shape of the swab will vary according to the specific
kind of collection it is intended for. Id.
Because the intrinsic record provides sufficient guidance to make the scope of
the claims reasonably certain to a person of ordinary skill in the art, Puritan has not
established by clear and convincing evidence that the claims including the phrase
“rod is suitable for human clinical collection” and its variants are indefinite.

I

therefore accord the term its plain and ordinary meaning.
f. “rigid”
The term “rigid” appears in the ‘784 Patent, the ‘358 Patent, and the ‘779
Patent, each of which states: “said rod tip is rigid.” ECF No. 72-3 at Page ID 788;
ECF No. 72-4 at Page ID 798; ECF No. 72-5 at Page ID 808. Puritan argues that this
term is indefinite because the intrinsic record provides no guidance as to the scope of
the term. Copan argues that the term should be accorded its plain and ordinary
meaning, which is clear even to a lay person.
The term “rigid” also appears in the specification, which states: “The tip of
the cylindrical rod, [is] generally manufactured from essentially rigid material such
as plastic. . . .” ECF No. 72-3 at Page ID 786. Puritan argues that this offers no
objective guidance to a person of ordinary skill in the art because plastic comes in
many forms. But plastic is simply an example of a material that may provide rigidity.
18

A person of ordinary skill reading the term in the context of the patents-in-suit would
understand that the swab needs to be rigid enough to perform the claimed method of
collecting liquid samples. Sometimes claim construction requires “little more than
the application of the widely accepted meaning of commonly understood words.”
Phillips, 415 F.3d at 1314. That is the case here. To the extent a definition is
required, I define “rigid” to be synonymous with “stiff.”
Puritan has not met its burden of proving indefiniteness. Thus, I find that a
person of ordinary skill in the art would be able to determine the scope of the claims
that include this term with reasonable certainty.
g. “an amount of fiber deposited”
The phrase “an amount of fiber deposited” appears in two independent claims
in the ‘358 Patent. Puritan argues that the term is indefinite because the intrinsic
record offers no guidance as to what the “amount” is or how to measure it. Though
Puritan identifies several parts of the specification that provide examples or
instruction regarding calculation of the amount of fiber that is required, it argues
that they provide no guidance.
But no further guidance is needed. In Claims 1 and 14 of the ‘358 Patent, the
term appears as follows: “an amount of fiber deposited forming the flocked layer being
configured to enable 40 µl of specimen to be absorbed in said layer of fibers on the tip
of the rod.” ECF No. 72-4 at Page ID 798. In this context, even a layperson would
understand that “an amount of fiber deposited” means the amount necessary for the
layer of fibers to absorb 40 microliters of specimen. Example 1 of the specification
confirms this understanding, stating: “The polyamide flock of 0.7 mm length and 1.7
19

Dtex allows 0.5 µl per mm to be absorbed, therefore by flocking the 10 mm long tip of
said rod the absorbing capacity obtained is 40 µl.” ‘358 Patent, ECF No. 72-4 at Page
ID 797. This informs a person of skill in the art that the amount of fiber must be
calculated based on the type of fiber being used, and it provides an example of a fiber
length and density that would allow for the collection of 40 microliters of specimen.
Thus, the context of the claims and the specification would inform a person of
ordinary skill in the art of the invention’s scope with reasonable certainty.
“Reasonable certainty does not require absolute or mathematical precision.” BASF
Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017) (quotation marks
omitted). Additionally, the standard “does not exclude claim language that identifies
a product by what it does. Nothing inherent in the standard of ‘reasonable certainty’
precludes a relevant skilled artisan from understanding with reasonable certainty
what compositions perform a particular function.” Id. at 1366.
Puritan contends that, under the doctrine of claim differentiation, the
specification cannot serve as guidance for defining the term “an amount of fiber
deposited” because the specification does not use that term while discussing the
absorption capacity of the swab. Puritan asserts that without such guidance, the
term is indefinite. But claim differentiation ordinarily applies only to prohibit
incorporating dependent claim limitations into the construction of independent claim
terms. See GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1310 (Fed. Cir.
2014). It does not preclude construing a claim term in light of the specification,
including portions of the specification that do not explicitly reference the claim term.
Thus, the cited portions of the specification can properly inform the construction of
20

“an amount of fiber deposited.”

Because the patent as a whole would provide

reasonably certainty as to the meaning of this term to a person of ordinary skill in
the art, as discussed above, the term is not indefinite and is accorded its plain and
ordinary meaning.
5. Other Claim Terms
a. “uniform thickness”
The term “uniform thickness” appears in all five of the patents-in-suit, once in
an independent claim and five times in dependent claims. Copan and Puritan both
argue that this term should be given its plain and ordinary meaning, but Puritan
offers the following construction, with which Copan disagrees: “the fibers have the
same height over the entire layer of fibers without interruptions.” ECF No. 77 at
Page ID 2182; see also ECF No. 78 at Page ID 2263. Puritan draws its definition from
portions of the prosecution history.
I begin, as I must, with the language of the claims. Endo Pharm., 922 F.3d at
1370. In context, “thickness” describes the “layer of fibers” on the tip of the flocked
swab. For example, Claim 1 of the ‘027 Patent describes the claimed invention as “a
swab comprising a rod terminating in a tip [and] a layer of fibers of uniform
thickness,” and the specification explains that the fibers should be “disposed as a
layer of uniform thickness.” ‘027 Patent, ECF No. 72-1 at Page ID 769, 770. As
discussed above in the context of the term “a thickness between 0.6 and 3 mm,” the
thickness of the layer depends upon the fiber length. Additionally, “uniform” is a
commonly understood word synonymous with “constant.” Talarico v. Marathon Shoe
Co., 182 F. Supp. 2d 102, 109−110 (D. Me. 2002); see also Ductmate Indus., Inc. v.
21

Famous Supply Corp., 55 F. Supp. 2d 777 (N.D. Ohio 1999) (construing “uniform
thickness” to mean “the same thickness throughout”). There is nothing in the record
to suggest that the inventor intended a more specific definition. Thus, a person of
ordinary skill in the art would understand the term “uniform thickness” to mean that
the layer of fibers on the tip of the swab must have a constant thickness. Because
the meaning of “uniform thickness” is plain, I conclude that no further construction
is required and decline to adopt Puritan’s proposed definition.
b. “covering the tip” / “cover the tip”
The terms “covering the tip” and “cover the tip” appear in independent claims
in the ‘027 Patent and the ‘728 Patent, both of which claim a method for using a
flocked swab to collect a liquid5 specimen for analysis. Copan argues that the terms
should be given their plain and ordinary meaning. Puritan argues that Copan acted
as its own lexicographer and urges the adoption of the following definition: “Flocking
is completed to saturation, when no more fibers can be anchored to the surface, with
a very high packing density of the deposited fibers, close to an ideal hexagonal close
packing of fibers.” ECF No. 77 at Page ID 2184.
Acting as one’s own lexicographer is one of two exceptions to the general rule
that terms should be given their plain and ordinary meaning. Aventis Pharma, 675
F.3d at 1330. A patentee acts as its own lexicographer if it “‘clearly set[s] forth a
definition of the disputed claim term’ other than [the term’s] plain and ordinary

5

The word “liquid” appears only in Claim 1 of the ‘027 Patent, not Claim 1 of the ‘728 Patent, but both claims
recite a method for collecting 40 to 100 microliters of specimen. Compare ‘027 Patent, ECF No. 72-1 at Page ID
770, with ‘728 Patent, ECF No. 72-2 at Page ID 779. Therefore, even where the word “liquid” is not present, a
person of ordinary skill in the art would likely infer from the use of a volume measurement that the specimen to
be absorbed is liquid.
22

meaning.” Thorner, 669 F.3d at 1365 (quoting CCS Fitness, 288 F.3d at 1366). Here,
Puritan argues that Copan acted as its own lexicographer when it defined “covering
the tip” during the prosecution of one of its European patents. But this prosecution
communication fails to establish that Triva, the applicant, “clearly set forth a
definition” of “covering the tip” other than the plain and ordinary meaning of that
term for two reasons. First, the communication is part of the prosecution history of
Copan’s European patent, not a patent-in-suit. Second, it is part of the prosecution
history and not the patent itself. While the prosecution history may aid a court in
construing claim terms, it is often less relevant than the patent itself: “[B]ecause the
prosecution history represents an ongoing negotiation between the [Patent and
Trademark Office] and the applicant, rather than the final product of that
negotiation, it often lacks the clarity of the specification and thus is less useful for
claim construction purposes.” Phillips, 415 F.3d at 1317.
Because the prosecution history does not establish that Copan acted as its own
lexicographer, the terms should be given their plain and ordinary meaning. In the
context of the invention, the terms “covering the tip” and “cover the tip” have a plain
meaning that is apparent even to a layperson: forming a layer over the tip of the
swab. That construction is also consistent with Figure 2, which appears in each of
the patents-in-suit and depicts the flocked swab:

23

ECF No. 72-1 at Page ID 767.
Puritan’s proposed definition is inconsistent with this plain meaning because
it adds limitations that do not make sense in the context of the patents. Specifically,
Puritan proposes that “covering the tip” requires fibers to be attached to the tip “with
a very high packing density” until “no more fibers can be anchored to the surface.”
ECF No. 77 at Page ID 2184. But the invention claimed in the ‘027 and ‘728 Patents
is a method for collecting a certain number of microliters of liquid specimen for
analysis, which would indicate to a person of ordinary skill in the art that there needs
to be some space between the fibers so that the liquid can be absorbed into the flocked
tip of the swab. See ECF No. 72-1 at Page ID 769−70; ECF No. 72-2 at Page ID 779.
I therefore decline to adopt Puritan’s proposed definition and construe the terms
“covering the tip” and “cover the tip” according to their plain and ordinary meaning,
as described above.

24

c. “perpendicular” / “perpendicularly”
The term “perpendicular” or “perpendicularly” appears in all five of the
patents-in-suit, in eight independent claims and one dependent claim. See ‘027
Patent, Claim 1, ECF No. 72-1 at Page ID 769; ‘728 Patent, Claim 6, ECF No. 72-2 at
Page ID 779; ‘784 Patent, Claim 1, ECF No. 72-3 at Page ID 788; ‘358 Patent, Claims
1, 14, 23, 24, ECF No. 72-4 at Page ID 798; ‘779 Patent, Claims 1, 13, ECF No. 72-5
at Page ID 808. Copan argues that the term should be accorded its plain and ordinary
meaning. Puritan argues that the plain and ordinary meaning does not govern claim
construction because Copan disavowed the full scope of the term during prosecution.
Prosecution disavowal is one of two exceptions to the general rule that a claim
term is construed according to its plain and ordinary meaning.   Uship Intellectual
Props., LLC v. United States, 714 F.3d 1311, 1313 (Fed. Cir. 2013). “Since it is the
claims that define the metes and bounds of the patentee’s invention, the patentee is
free to choose a broad term and expect to obtain the full scope of its plain and ordinary
meaning unless the patentee explicitly disavows its full scope.” Intellectual Ventures
I LLC v. T-Mobile USA, Inc., 902 F.3d 1372, 1378 (Fed. Cir. 2018) (internal
alterations and quotation marks omitted). Disavowal is an “exacting” standard.
Thorner, 669 F.3d at 1366.
In support of its prosecution disavowal argument, Puritan points out that,
during prosecution, the patent examiner objected to a claim that required the layer
of fibers to be “disposed substantially perpendicular to a surface of the tip.” ECF No.
73-30 at Page ID 1761. Copan responded by amending the claim to remove the term
“substantially,” after which the claim read: “said layer of fibers are [sic] directly
25

disposed on said tip in an ordered arrangement and perpendicular to a surface of the
tip by flocking.” ECF No. 73-31 at Page ID 1785. Puritan asserts that Copan
disavowed of the full scope of the term “perpendicular” by making this amendment
and thus proposes the following definition: “the fibers must stand upright at precisely
90 degrees to the tangent of the surface of the tip of the swab.” ECF No. 77 at Page
ID 2190−91. But Copan’s amendment, at most, disavowed the term “substantially
perpendicular,” in favor of the term “perpendicular.” While this apparent disavowal
would prevent Copan from attempting to reinsert the word “substantially” before
“perpendicular,” it does not affect the plain and ordinary meaning of “perpendicular.”
Thus, the prosecution disavowal exception does not apply, and the plain and ordinary
meaning governs.
Within

the

context

of

the

claims,

the

terms

“perpendicular”

and

“perpendicularly” describe how the fibers are oriented with respect to the surface of
the swab rod during the flocking process. The language of the patents themselves
supports this construction:

The independent claims where “perpendicular” and

“perpendicularly” appear all use the terms in the context of describing “a flocking
technique in which the fibers were deposited, in an electrostatic field, in an ordered
manner perpendicularly to the surface of the tip of the swab rod . . . .” E.g., ‘358
Patent, Claim 1, ECF No. 72-4 at Page ID 798. Therefore, as Copan argues, a person
of ordinary skill in the art would understand that “during the flocking process an
electrostatic field causes the fibers to ‘fly’ towards the surface such that they are
perpendicular to the surface being flocked and parallel to each other, attaching to a
previously applied adhesive.” ECF No. 72 at Page ID 750. A person of ordinary skill
26

in the art would also understand that the fibers would not remain perfectly
perpendicular after they adhere to the swab, contrary to Puritan’s proposed
definition. Thus, I decline to adopt Puritan’s proposed definition and construe the
terms “perpendicular” and “perpendicularly” according to their plain and ordinary
meaning.
d. “0.5 µl of liquid specimen are absorbed per mm2 of said
layer of fibers”
The phrase “0.5 µl of liquid specimen are absorbed per mm2 of said layer of
fibers” appears only once in the asserted patents, in a dependent claim of the ‘027
Patent. ECF No. 72-1 at Page ID 770. Copan argues that the term should be given
its plain and ordinary meaning. Puritan argues that Copan disavowed the full scope
of the term “0.5 µl” because it removed the words “about or at least” immediately
preceding “0.5 µl” during prosecution. Puritan thus asserts that the word “0.5 µl”
should be construed as “exactly 0.5 µl.” ECF No. 77 at Page ID 2203. But here, as
with the term “perpendicular,” the plain meaning of the disputed term is not affected
by the alleged disavowal. A person of ordinary skill in the art reading the numerical
value in this contested term would understand it to mean just what it says—that
each square millimeter of the layer of fibers absorbs 0.5 microliters of liquid specimen.
Therefore, I conclude that this term needs no further construction.
e. “90%”
The term “90%” appears in a dependent claim of the ‘779 Patent, which reads:
“The swab according to claim 1, wherein said layer of fibers is configured to be capable
of releasing 90% of the quantity of specimen absorbed.” ECF No. 72-5 at Page ID 808.
27

Copan argues that the term should be given its plain and ordinary meaning, while
Puritan asserts that the proper construction is “precisely 90%” because Copan
disavowed any broader scope during prosecution.
To support its prosecution disavowal argument, Puritan points out that Copan
amended the claim to read “90%” instead of “about 90%” after the patent examiner
objected that the word “about” rendered the claim indefinite because it was “unclear
how close to being configured to release 90% of the quantity of specimen absorbed a
device could be while being inside or outside of the scope of the claim . . . .” ECF No.
73-34 at Page ID 1873; ECF No. 77 at Page ID 2204−05. However, while Copan may
have disavowed the full scope of the phrase “about 90%” by making that amendment,
such a disavowal would only prevent Copan from now arguing that “90%” means
“about 90%,” an argument which Copan has not pressed. Puritan has presented no
evidence that Copan intended to define “90%” as “precisely 90%.” Accordingly, I
conclude that Copan did not disavow the full scope of the term “90%” and construe
the term according to its plain and ordinary meaning.
On its own, the ordinary meaning of “90%” is ambiguous. The key context
within the claim comes from the phrase “configured to be capable of releasing.” ECF
No. 72-5 at Page ID 808. A layer of fibers would fall within the scope of this claim if
it were configured to be capable of releasing precisely 90% of the collected specimen,
but it would also fall within the scope of the claim if it were configured to be capable
of releasing, for example, 91% or 96% of the collected specimen. In other words, a
swab that is capable of releasing greater than 90% of the collected specimen would
necessarily fall within this claim because it would encompass the lesser value of 90%.
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Accordingly, viewing the term “90%” in the context of the claim where it appears, I
conclude that the addition of the word “precisely” is inconsistent with the ordinary
meaning of “90%.” Therefore, I decline to adopt Puritan’s proposed definition and
find that the term “90%” requires no further construction.
f. “from 90% to 100%”
The phrase “from 90% to 100%” appears in a dependent claim of the ‘728 Patent
which reads: “The method according to claim 1 further comprising: releasing, from
said layer of fibers, a quantity from 90% to 100% of said specimen absorbed.” ECF
No. 72-2 at Page ID 779. Copan argues that the term should be given its plain and
ordinary meaning, while Puritan proposes a precise definition and argues that Copan
disavowed any broader scope during prosecution by amending the claim from its
original language, “at least about 90%,” ECF No. 73-16 at Page ID 1516, to read “from
90% to 100%.” ECF No. 73-20 at Page ID 1583. Puritan’s proposed construction is:
“a percentage within the closed range of 90% to 100% (including endpoints).” ECF
No. 77 at Page ID 2205.
Again, prosecution disavowal does not apply because Copan does not argue
that the term “from 90% to 100%” should be construed to mean “from about 90% to
100%.” The phrase “from 90% to 100%” has a plain and ordinary meaning that a
person of ordinary skill in the art, and even a layperson, can easily discern. To the
extent further construction of the term is required, the word “from” in this context
means “between.” Therefore, I construe “from 90% to 100%” to mean “between 90%
and 100%.”

29

III. CONCLUSION
For the foregoing reasons, it is ORDERED that the claim terms are construed
as follows:
1. The preambles do not limit the claims, but rather provide a statement of
intended use;
2. The parties agree that “tip” means “the flocked end of a swab”;
3. The parties agree that “swab” means “a stick or wire with a small piece of
absorbent material attached to the end”;
4. The term “ordered arrangement” / “ordered manner” is not indefinite and is
accorded its plain and ordinary meaning in the context of the patents;
5. The term “a thickness between 0.6 and 3 mm” and its variants are not
indefinite and are accorded their plain and ordinary meaning in the context of
the patents, where “thickness” refers to the layer of fibers and depends upon
the length of the fibers;
6. The term “fibers define capillaries in said layer of fibers, conferring hydrophilic
properties by capillarity to the layer of fibers” and its variants are not
indefinite, and “hydrophilic . . . by capillarity” is construed according to its
plain and ordinary meaning in the context of the patents, as referring to the
additional hydrophilic effect created by the space between the fibers when it
draws liquid into the layer of fibers by capillary action;
7. The term “about 90%” is not indefinite and is accorded its plain and ordinary
meaning in the context of the patents, which is “approximately 90%”;
8. The terms “rod is suitable for human clinical collection” and its variant, “a
clinical swab, configured for human clinical collection” are not indefinite and
are accorded their plain and ordinary meaning in the context of the patents;
9. The term “rigid” is not indefinite and is accorded its plain and ordinary
meaning in the context of the patents, which is “stiff”;
10. The term “an amount of fiber deposited” is not indefinite and is accorded its
plain and ordinary meaning in the context of the patent;
11. The term “uniform thickness” is accorded its plain and ordinary meaning in
the context of the patents;
30

12. The term “covering the tip” / “cover the tip” is accorded its plain and ordinary
meaning in the context of the patents, which is “forming a layer over the tip of
the swab”;
13. The term “perpendicular” / “perpendicularly” is accorded its plain and
ordinary meaning in the context of the patents;
14. The term “0.5 µl of liquid specimen are absorbed per mm2 of said layer of
fibers” requires no further construction beyond its plain meaning;
15. The term “90%” requires no further construction beyond its plain meaning;
and
16. The term “from 90% to 100%” is accorded its plain and ordinary meaning in
the context of the patent, which is “between 90% and 100%.”
SO ORDERED.
Dated this 4th day of November, 2019.
/s/ JON D. LEVY
CHIEF U.S. DISTRICT JUDGE

31