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Tissue Anchor Innovations LLC v. ASTORA Women's Health, LLC

United States District Court, E.D. Virginia, Norfolk Division

July 6, 2016

TISSUE ANCHOR INNOVATIONS LLC, Plaintiff,
v.
ASTORA WOMEN'S HEALTH, LLC, Defendant.

          OPINION AND ORDER

          ROBERT G. DOMMAR SCNIOR UNITED STATES DISTRICT JUDGE

         This case concerns alleged infringements of a single patent owned by Doctor Christopher .1. Walshe ("Dr. Walshe") and for which Tissue Anchor Innovations LLC ("TAP) is the exclusive licensee. This patent, titled "Tissue Anchor System, 1' was issued on January 14. 2003 as United Slates Patent No. 6.506.190 ('"the ' 190 Patent"). Presently before the Court is the claim construction of several terms found within the claims of the "190 patent. After careful consideration of the briefs submitted by the parlies and the arguments advanced at the Markman hearing held on June 20, 2016, the Court issues the following Opinion and Order detailing the claim constructions in this case.

         I. FACTUAL AND PROCEDURAL HISTORY

         The '190 patent's abstract describes the invention at issue in this case as "a tissue-anchoring system, including a tissue-anchoring device and tissue anchors." Compl., Ex. 1 at Abstract, ECF No, 1-1. The patent discloses a system that "relates to a tissue anchor and applicator for supporting a suture, sling member, or other device for use in a surgical procedure. In particular, this invention relates to tissue anchors for use in surgical treatment of urinary incontinence." Id.. at 1:7-11. TA1 filed suit against defendant ASTORA Women's Health. LLC ("ASTORA") for patent infringement on October 28, 2015 alleging that a number of the medical devices ASTORA designs and sells addressing women's health concerns (collectively "ASTORA Systems"') directly and indirectly infringe the '190 patent. See Compl. ¶¶ 11-15. ECF No. 1. On January 13. 2015. after an extension of time granted by the United States Magistrate Judge upon a consent motion tiled by ASTORA. ASTORA filed its Answer, denying any infringement and asserting several affirmative defenses, including non-infringement, invalidity of the '190 patent, prosecution history estoppel, and other legal and equitable defenses. See Answer ¶¶19-42, F, CT; No. 25. Additionally, ASTORA alleges two counterclaims in its Answer, seeking declaratory judgment that it has not infringed the 7190 patent and that the '190 patent is invalid, id. at ¶¶ 10-20.

         On April 20, 2016. the parties filed a Joint Statement regarding claim construction that identified claim terms which one or both parties deemed necessary to construe. Joint Statement, ECF No. 33. After the parlies fully briefed their positions with respect to claim construction, the Court held a Markman hearing on June 20. 2016 at which it heard argument concerning the construction of the disputed claim terms.

         II. LEGAL STANDARDS

         The United States Supreme Court has explained that "a patent must describe the exact scope of an invention and its manufacture to "secure to [the patentee] all to which he is entitled, [and| to apprise the public of what is still open to them.'" Markman v. Westview Instruments, Inc.. 517 U.S. 370. 373 (1996) (quoting McClain v. Ortmayer, 141 U.S. 419. 424 (1891)). To that end, a patent "contains a specification describing the invention 'in such full, clear, concise, and exact terms as to enable any person skilled in the art ... to make and use the same'" and "one or more claims, which "particularly poin[t] out and distinctly clai[m] the subject matter which the applicant regards as his invention."" Id. (quoting 35 U.S.C. § 112). The claims identified in a patent define the scope of a patent grant and are central to resolving patent infringement suits as "[v]ictory [for the Plaintiff] . . . requires a finding that the patent claim 'covers the alleged infringer's product or process, 7 which in turn necessitates a determination of "what the words in the claim mean."" Id. at 374 (quoting II. Schwartz. Patent Law and Practice 80 (2d ed. 1995)}. "It is a 'bedrock principle' of patent law that 'the claims of a patent define the invention to which the patentee is entitled the right to exclude."' Phillips v. AWH Corp., 415 F.3d 1303. 1312 (Fed. Cir. 2005) (en bane) (quoting Innoval Pure Water. Inc. v. Safari Water Filtration Sys., 381 F.3d 1111. 1115 (Fed. Cir. 2004)).

         Construing the meaning of the words contained in a claim is a matter of law to be determined by the Court. Id. at 388. The purpose of such claim construction is to "dctermin[e] the meaning and scope of the patent claims asserted to be infringed." Markman v. Westview Instruments. Inc.. 52 F.3d 967. 976 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996).

         When construing patent claims "there is a heavy presumption that a claim term carries its ordinary and customary meaning." 3M innovative Properties Co. v. Avery Dennison Corp., 350 P.3d 1365. 1370 (Ped. Cir. 2003). "[T|he 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 lime of the invention, i.e.. as of the effective filing date of the patent application." Phillips, 415 P.3d at 1313. Moreover, "the 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.: see also Thorner v. Sony Computer Entm't Am. LLC. 669 F, 3d 1362. 1365 (Fed. Cir, 2012) ("The words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history. There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.") (internal citations omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than application of the widely accepted meaning of commonly understood words." Phillips. 415 F.3d at 1314. As the Federal Circuit has repeatedly held, "a district court is not obligated to construe terms with ordinary meanings, lest trial courts be inundated with requests to parse the meaning of every word in the asserted claims." 02 Micro Int'l Ltd v. Beyond innovation Tech. Co., Ltd.. 521 F.3d 1351, 1360 (Fed. Cir. 2008) (footnote omitted); see also Id. at 1362 ("|District courts are not (and should not be) required to construe every limitation present in a patent's asserted claims .... Claim construction "is not an obligatory exercise is redundancy.7") (quoting U.S. Surgical Corp. v. Ethicon. Inc.. 103 F.3d 1554, 1568 (Fed. Cir. 1997)) (emphasis in original).

         In other eases, however, "determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art." Phillips. 415 F.3d at 1314. In such cases, the Court must 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. Those sources 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. (internal quotation marks omitted).

         When determining the meaning of disputed terms or phrases, the Court must begin with the intrinsic record, which consists of the claims, the specification, and the prosecution history. Markman, 52 F.3d at 979. The Court looks first lo the claim language, then "to the rest of the intrinsic evidence, beginning with the specification and concluding with the prosecution history, if in evidence." Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323. 1331 (Fed. Cir. 2001). "Such intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language." Vitrionics Corp. v. Conceptronic, Inc.. 90 F.3d 1576, 1582 (Fed. Cir. 1996).

         The Court, when examining the intrinsic record, first looks "to the words of the claims themselves, both asserted and nonasscrlcd, to define the scope of the patented invention." Vitrionics. 90 F.3d at 1582. Both asserted and nonasscrlcd claims can be "valuable sources of enlightenment as to the meaning of a claim term" because "claim terms are normally used consistently throughout the paten\." Phillips, 415 F.3d at 1314. Superfluity is to be avoided if possible when construing claim language. See Marine Polymer Technologies, Inc. v. HemCon, Inc.. dl2 F.3d 1350, 1368 (Fed. Cir. 2012) ("Where a particular construction of an independent claim would nullify claims that depend from it, the doctrine of claim differentiation creates a presumption that such a construction is improper."); Merck & Co.. Inc. v. Teva Pharm. USA. Inc., 395 F.3d 1364. 1372 (Fed. Cir. 2005) ("A claim construction that gives meaning to all the terms of the claim is preferred over one that docs not do so.11); Coinark Commc'm, Inc. v. Harris Corp.. 156 F.3d 1182. 1187 (Fed. Cir. 1998) (recognizing that while "the doctrine of claim differentiation is not a hard and fast rule of construction, it does create a presumption that each claim in a patent has a different scope"). "If the claim language is clear on its face, then [the Court's] consideration of the rest of the intrinsic evidence is restricted to determining if a deviation from the clear language of the claims is specified." Interactive Gift Express, 256 F.3d al 1331. As the Federal Circuit has reiterated, there are only two circumstances in which claim interpretation may deviate from the ordinary and customary meaning of the claim terms: "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." Thomer v. Sony Entm't Am. LLC. 669 F.3d 1362. 1365 (Fed. Cir. 2012); see also Phillips. 415 F.3d at 1316-17; Interactive Gift Express. 256 F.3d at 1331. An "exacting" standard must be met in order for an inventor to disavow the full scope of a claim. Thorner, 669 F.3d at 1366. "If however the claim language is not clear on its face, then our consideration of the rest of the intrinsic evidence is directed to resolving, if possible the lack of clarity. Interactive Gift Express, 256F.3dat 1331.

         The Court looks next to the specification to resolve unclear claim language and to "determine whether the inventor has used any terms in a manner inconsistent with their ordinary meaning.'" Vitrionics, 90 F.3d al 1582. "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." Markman, 52 F.3d at 979. The specification, as required by statute, describes the claimed invention in "full, clear, concise, and exact terms." 35 U.S.C. § 112(a). "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." Markman. 52 F.3d at 979. aff'cd. 517 U.S. 370. The specification "may [also] reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. "In other cases, the specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor."' Id. "[Although the specification often describes very specifies embodiments of the invention, [the Federal Circuit has] repeatedly warned against confining the claims to those embodiments." Id. at 1323.

To avoid importing limitations from the specification into the claims, it is important to keep in mind that the purposes of the specification are to teach and enable those of skill in the art to make and use the invention and to provide a best mode for doing so. One of the best ways to leach a person of ordinary skill in the art how to make and use the invention is to provide an example of how to practice the invention in a particular case. Much of the lime, upon reading the specification in that context, it will become clear whether the patentee is setting out specific examples of the invention to accomplish those goals, or whether the patentee instead intends for the claims and the embodiments in the specification to be strictly coextensive.

Id. *"[T]hc specification 'is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."" Id. at 1315 (quoting Vitrionics, 90 F, 3d at 1582).

         In addition to the claim terms themselves and the specification, the Court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980. The prosecution history "consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317; Vitrionics, 90 F.3d at 15S2. "Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent, " but "because the prosecution history represents an ongoing negotiation between the PTO 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. "Nonetheless, 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." Id.

         Finally, the Court may also examine extrinsic evidence, which includes "all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. "[W]hile extrinsic evidence 'can shed useful light on the relevant art, 1 [the Federal Circuit has] explained that it is 'less significant than the intrinsic record in determining the legally operative meaning of the claim.'" Phillips: 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858. 862 (Fed. Cir. 2004)) (internal quotations omitted).

         With these principles in mind, the Court proceeds with construction of the disputed claim terms.

         III. CLAIM CONSTRUCTION

         Prior to the Markman hearing conducted hy the Court, the parties filed a Joint Statement Regarding Claim Construction, BCF No. 33. that included two agreed-upon claim term constructions, an agreement that an element found in Claim 1 should he divided into two phrases and construed separately, and ten disputed claim terms. The Court adopts the parlies' stipulated construction of the agreed-upon terms and the agreed-upon division of an element found in Claim 1 as the Court only need construe claims "to the extent necessary to resolve ... [a] controversy." Vivid Techs., Inc. v. Am. Science Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (internal citations omitted). Accordingly, the term "shaft" as used in Claim 2 is construed to mean "a structure attached to the barb end of the tissue anchor11; the phrase "on said shaft distal from said barb end" as used in Claim 2 is construed to mean "located on the shaft in a direction opposite or away from the barb end"; and the element "said anchor having a barb end and a barb with a tip shaped to penetrate soft tissue position thereon" is interpreted separately as an anchor having a "barb end . ., with a lip shaped to penetrate soft tissue . . .'" and a "barb" positioned on the barb end. See Joint Statement at I, ECF No. 33.

         Of the remaining ten disputed claim terms, TAI argues six do not require construction. Although the Court may make a determination based on the intrinsic and extrinsic evidence that a claim term needs no construction and should be understood by its plain and ordinary meaning, such a determination "may be inadequate when a term has more than one 'ordinary' meaning or when reliance on a term's 'ordinary' meaning does not resolve the parties' dispute." 02 Micro Int. Ltd. v, Beyond Innovation Tech. Co.. 521 F.3d 1351, 1361 (Fed. Cir. 2008). If such a situation arises, the Court will follow the Federal Circuit's instruction to construe claims "that arc in controversy, and only to the extent necessary to resolve the controversy." Vivid Techs., Inc. v. Am. Science Kng'g Inc., 200 F.3d 795. 803 (Fed. Cir. 1999} (internal citations omitted): see also 02 Micro, 521 F.3d at 1362 (noting that when "the parties present a fundamental dispute regarding the scope of a claim term, it is the court's duty to resolve it."). The ten disputed terms are addressed individually herein.

         A. "tissue anchor" (Claims 1-8)

         The "190 patent discloses a tissue anchoring system, which includes a tissue anchoring device and tissue anchors. See '190 Patent at Abstract. The parties contest the construction of a key part of this system - the "tissue anchor" used in Claims 1-8 of the '190 patent.

         TAI contends that the proper construction of the learn "tissue anchor" is "a rigid device to be inserted into soft tissue to fixedly retain a separate item with respect to the soft tissue." Joint Statement at 2, ECF No. 33. In support of this construction. TAI argues its proposed construction is consistent with the ordinary meaning of the term "anchor as a device inserted into something to retain a separate item to it" and that this ordinary meaning is evident in the use of the term throughout the '190 patent. PL's Opening Brief at 7-8, ECF No. 38 (internal quotations omitted). For example. TAI notes that the '190 patent provides that the tissue anchor "has a tip 130 adapted to penetrate soft tissue.'[1] that the "[t]ip 130 should be fairly rigid to ease tissue penetration."[2] that the anchor may be "inserted in or thorough a tissue and anchored by [the] barb.[3] and that "the attachment member [may include] holes]] for attaching sutures or other suitable items." such as "'synthetic mesh [or] graft for later suspension of the vaginal vault to the sacrum.[4]

         In contrast, ASTORA proposes the following construction for "tissue anchor": "a device capable of independently piercing intact soft tissue and being retained after piercing." Joint Statement at 2, ECF No. 33. In support of its construction, ASTORA first contends that the '190 patent describes "tissue anchors" that arc capable of independently piercing into or through intact soft tissue[5] and that the prosecution history demonstrates Dr. Walshe. through counsel, disclaimed or disavowed embodiments of the tissue anchor ...


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