United States District Court, D. Maine
CLAIM CONSTRUCTION ORDER
JON D.
LEVY, CHIEF U.S. DISTRICT JUDGE
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 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).
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 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.
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 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 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.
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.
...