Copan Italia S.P.A. v. Puritan Medical Products Company LLC

          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. ...