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Medtronic, Inc. v. Edwards Lifesciences Corp.

United States District Court, Eighth Circuit

May 16, 2013

Medtronic, Inc. and Medtronic USA, Inc., Plaintiffs,
v.
Edwards Lifesciences Corp., Edwards Lifesciences, LLC, and Edwards Lifesciences (U.S.) Inc., Defendants. Edwards Lifesciences Corp., Edwards Lifesciences, LLC, and Edwards Lifesciences (U.S.) Inc., Counterclaimants,
v.
Medtronic, Inc., Medtronic USA, Inc., and Medtronic Vascular Inc. Counterdefendants.

ORDER

JOAN N. ERICKSEN, District Judge.

Plaintiffs Medtronic, Inc. and Medtronic USA, Inc. (collectively, "Medtronic") brought this patent infringement action against Defendants Edwards Lifesciences Corp., Edwards Lifesciences, LLC, and Edwards Lifesciences (U.S.) Inc. (collectively, "Edwards"). Edwards counterclaimed, asserting patent infringement claims against Medtronic. The case is before the Court to construe disputed patent claim terms pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).

I. BACKGROUND

Medtronic accuses Edwards of infringing four patents: U.S. Patent No. 7, 468, 073 (filed Apr. 11, 2006)) ('073 Patent), U.S. Patent No. 7, 503, 929 (filed Jan. 23, 2006) ('929 Patent), U.S. Patent No. RE42, 395 (filed Oct. 12, 2007) ('395 Patent), and U.S. Patent No. 6, 004, 330 (filed Mar. 3, 1995) ('330 Patent). Edwards accuses Medtronic of infringing three patents (the "McCarthy Patents"): U.S. Patent No. 6, 749, 630 (filed Aug. 28, 2001) ('630 Patent), U.S. Patent No. 8, 114, 155 (filed Apr. 14, 2008) ('155 Patent), and U.S. Patent No. 8, 123, 800 (filed Apr. 14, 2005) ('800 Patent).

The '073, '929 and '395 Patents are directed toward bioprosthetic valve systems and holders used during surgical procedures to replace diseased heart valves. The '073 Patent and the '929 Patent are related patents with the same inventors and claim priority to the same provisional application filed January 2, 2002. The '330 Patent is directed toward a device used to filter and manipulate matter within the body. In this litigation, Medtronic asserts claims 1-4 and 6-13 of the '073 Patent, claims 1-5 and 19 of the '929 Patent, claim 9 of the '395 Patent, and claims 1, 4, 7, 8, 10, 15, and 17-19 of the '330 Patent.

The three McCarthy Patents are members of the same patent family and all have the same inventors. The patents relate generally to annuloplasty, a surgical procedure used to improve the functioning of the mitral and tricuspid valves in the heart. During annuloplasty, an artificial ring is sewn onto the natural annulus of the valve to provide support to the valve. The '630 and '155 Patents relate to the annuloplasty rings; the '800 Patent relates to the template used to deliver the annuloplasty ring to the surgical site.[1] Edwards asserts claims 1, 10 and 11 of the '630 Patent, claims 1-4, 9, 11-14, 16, 19, 21-22 and 27 of the '155 Patent, and claims 1, 4-8, 10-12, 15-19, 21 and 22 of the '800 Patent.

II. DISCUSSION

The construction of patent claims "is a matter of law exclusively for the court." Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). "[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) (en banc) (internal quotation marks omitted). Words of 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 pertinent art at the time of the invention. Id. at 1312-13. "[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. at 1313. Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, a court should look to the sources available to the public that show what a person of skill in the art would have understood the claim language to mean. Id. at 1314. "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. (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)).

The claims provide substantial guidance as to the meaning of particular claim terms. Id. In some cases, the use of a term within the claim provides a firm basis for construing the term. Id. Other claims of the patent can be valuable sources of enlightenment as to the meaning of a claim term. Id. "Because claim terms are normally used consistently throughout the patent, the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. In addition, differences between claims can help determine the meaning of particular claim terms. Id. For example, a dependent claim that adds a particular limitation creates a presumption that the limitation is not present in the independent claim. Id. at 1314-15.

The claims do not stand alone, however, and "must be read in view of the specification, of which they are a part." Id. at 1315 (internal quotation marks omitted). The specification is "always highly relevant" to claim construction and usually is dispositive because it is "the single best guide to the meaning of a disputed term." Id. (internal quotation marks omitted).

In addition to the claims and specification, a court should consider the patent's prosecution history, if it is in evidence. Id. at 1317. The prosecution history can "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, a court may consider extrinsic evidence, which is "all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Id. (internal quotation marks omitted). Extrinsic evidence, however, is less significant than the intrinsic record in claim construction. Id.

A. '073 Patent

The '073 Patent, entitled "Heart Valve System, " claims a heart valve and holder, preferably for use in aortic valve repairs. A bioprosthetic heart valve typically includes a structural stent, from which commissure posts extend. The valve leaflets attach to these commissure posts. The replacement heart valves also include a sewing ring, which the surgeon sutures to the native tissue of the heart. During implantation of the replacement valve, the valve is attached to a holder that enables the surgeon to position the valve at the appropriate site and securely hold the valve in place until suturing is complete. Once the valve is sutured to the heart tissue, the holder is separated from the valve. Prior art valve holders attached to the commissure posts of the valve, which impeded the surgeon's access to the surgical site and precluded any inward deflection of the commissure posts. The valve holder of the '073 Patent improved upon the prior art by disclosing a valve holder that attached to the body of the valve "in the valleys defined between the commissure posts, " thus improving the surgeon's access and permitting the commissure posts to be inwardly deflected during implantation. '073 Patent col. 3 ll. 11-13; see also id. col. 1 ll. 54-57.

The parties request that the Court construe the following terms recited in the claims of the '073 Patent: "valve body, " "a holder having a holder body comprising a central portion engagable with a holder handle, " and "a holder having a holder body comprising a central portion coupled to a holder handle." These terms appear in several claims of the '073 Patent, but the Court need not recite all of the claims here, since the relevant portions of the various claims are nearly identical. Claim 1 recites:

1. A bioprosthetic heart valve system, comprising: a heart valve comprising a valve body having a plurality of commissure posts extending to a first end of the valve body, each commissure post ending in a tip portion, a stent including a peripheral edge at a second end of the valve body, and a sewing ring that is spaced from the tip portions of the commissure posts and extending along the peripheral edge defining a ring structure at the second end of the valve body; and a holder having a holder body comprising a central portion engagable with a holder handle and having a plurality of legs extending downwardly from the central portion, releasably coupled to the valve body intermediate the commissure posts.

Claim 7 recites:

7. A bioprosthetic heart valve system, comprising: a heart valve...; and a holder having a holder body comprising a central portion coupled to a holder handle and having a plurality of legs extending downwardly from the central portion, releasably coupled to the valve body intermediate the commissure posts.

1. "Valve body"

The claim language provides that the valve body has "a plurality of commissure posts extending to a first end of the valve body..., a stent including a peripheral edge at a second end of the valve body, and a sewing ring that is spaced from the tip portions of the commissure posts and extending along the peripheral edge defining a ring structure at the second end of the valve body." Edwards initially proposed that the valve body also include leaflets, but has since abandoned that proposal. Edwards harbors concern, however, that Medtronic wants to include a fabric covering as part of the "valve body." The Court does not read Medtronic's proposed construction as suggesting that fabric be read into the claim language, and Medtronic did not assert at oral argument that fabric should be included. The claim language itself, which clearly provides the structure of the valve body, does not include any reference to either leaflets or fabric. With the understanding that the "valve body" as recited in the claims does not include leaflets or fabric, no further construction of this claim term is required.[2]

2. "A holder having a holder body comprising a central portion engagable with a holder handle" and "a holder having a holder body comprising a central portion coupled to a holder handle."

Edwards's proposed construction for these terms is as follows: "a holder having a holder body with a central portion that can be engaged with a holder handle to deflect the commissure posts" and "a holder having a holder body with a central portion that is connected to a holder handle to deflect the commissure posts." Medtronic contends that no construction of these claim terms is required.

The main dispute is Edwards' assertion that these claim terms require that the holder body not only be engaged or connected to the holder handle, but that the holder body also be able to deflect the commissure posts. Language concerning deflection is notably absent from the claims themselves. For support, Edwards points to language in the specification, which provides that the holder is able to inwardly deflect the stent posts. See, e.g., '073 Patent, abstract; id. col. 1 ll. 48-67. The specification explains that the invention provides two distinct benefits: first, it provides inward deflection of the stent posts, and second, it improves a surgeon's access by attaching to the valve body in the valleys between the commissure posts. The claims expressly recite a holder that is "releasably coupled to the valve body intermediate the commissure posts." Id., claim 1. But despite the specification's repeated disclosure of a holder that inwardly deflects the stent posts, conspicuously absent from the '073 Patent is any claim that actually claims such a deflection device. At first glance, this omission seems rather odd. But the '073 Patent is only one of a family of related patents-the '929 Patent also claims priority to the same provisional application. The '929 Patent, which will be discussed in greater detail below, claims a deflection device for inwardly deflecting the stent posts. Thus, it becomes clear that the claims of the '073 Patent are directed only at a holder that attaches to the valve body somewhere other than at the commissure posts, and the claims of the '929 Patent are directed at a holder that inwardly deflects the commissure posts. This construction is supported by the specification of the '073 Patent, which provides:

It should be noted that while the preferred embodiment of the valve holder according to the present invention includes a mechanism for producing inward deflection of the commissure posts, it is believed that a holder having the general configuration illustrated, e.g. a central portion having three downwardly extending legs adapted to engage the valve between the commissure posts is also useful in the context of a holder which does not include a mechanism for inward deflection of the commissure posts. Such a design retains the compact overall configuration of the holder as illustrated in the present application, improving the surgeon's access as compared to a holder mounted to the tips of the commissure posts as in the [prior art]. The placement of the downwardly extending legs between the commissure posts, even without inward deflection, also still serves to provide additional protection of the leaflets of the valve against inadvertent damage...."

'073 Patent col. 5 ll. 26-42.

The file history of the '073 Patent confirms that the invention is directed only at a holder that attaches to the valve body in a location between the stent posts. "[T]he present invention is directed to the provision of a holder that releasably connects between commissure posts of a stented valve.... The novel and unobvious holder and heart valve combination of the present invention further facilitates implantation of a heart valve of the claimed type without the holder being engaged with the commissure post tips." Hannah Decl. Ex. 22, at 8 (ECF No. 89-22). Edwards asserts that other language in the file history constitutes a clear intention by the inventor for the holder of the '073 Patent to itself be able to deflect the stent posts. "By the present amendment, independent claims 38 [claim 1 as issued], 43, 45, and 46 are amended to emphasize the valve construction of the present invention as such heart valve is provided with a specifically designed holder to facilitate implantation of the heart valve with commissure posts deflected inwardly." Id. "While releasably engaging the heart valve body in the valleys between commissure posts, the commissure posts can still be effectively deflected for implantation." Id. Contrary to Edwards' beliefs, this language does not require that the holder be able to deflect the commissure posts. Rather, these statements only emphasize the benefits of having a holder that attaches in the valleys between the posts, rather than to the tips of the commissure posts. A holder attached to the tips of the commissure posts does not allow those posts to be inwardly deflected. In contrast, a holder attached in the valleys between the commissure posts allows for those posts to be inwardly deflected while still attached to the holder. By connecting to the valve body in this novel manner, the holder allows for the deflection of the commissure posts-but it need not provide the deflection.

The construction requested by Edwards would add limitations not found in the claims themselves. There is nothing in the intrinsic record that constitutes a clear disavowal of the broader claim scope, nor is there any other evidence that suggests it is appropriate for the Court to import a deflection limitation from the specification into the claim language. "Absent a clear disavowal or contrary definition in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language." Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004). Neither the specification nor the file history supports Edwards' proposed construction. Thus, the Court concludes that "a holder having a holder body comprising a central portion engagable with a holder handle" and "a holder having a holder body comprising a central portion coupled to a holder handle" do not require that the holder inwardly deflect the commissure posts. With that understanding, the claim language is clear and no further construction is necessary.

B. '929 Patent

The '929 Patent, titled "Prosthetic Heart Valve System, " claims and discloses a prosthetic heart valve system comprising a prosthetic heart valve, a deflection device for inwardly deflecting the stent posts of the heart valve, and a holder for the heart valve. Inward deflection of the stent posts is particularly important when performing a mitral valve replacement, because during the surgical procedure, the mitral valve is implanted by placing the prosthesis "with the stent posts projecting blindly deep into the patient's left ventricle." '929 Patent col. 1 ll. 63-64. "Due to a lack of visibility through the prosthetic valve, a surgeon can inadvertently loop sutures around the stent posts, " and the "stent posts may undesirably snag' on chordae or trabeculae inside the left ventricular cavity." Id. col. 1 l. 64-col. 2 l. 2. Inward deflection is also important when performing aortic valve replacement, because during this procedure, "a surgeon is often faced with little room to maneuver, " and non-deflected stent posts can interfere with the surgeon's ability to perform the maneuvers required. Id. col. 2 ll. 39-61. Prior art deflection devices and holders, however, were poorly suited for aortic valve replacements. Id. col. 2 l. 64col. 3 l. 41. The invention of the '929 Patent sought to improve upon the prior art by disclosing a "preassembled stent post deflection device that is safe, simple in form and operation, and appropriate for any heart valve location, including the aortic valve." Id. col. 3 ll. 38-14.

Medtronic has asserted independent claim 1 and dependent claims 2-5 and 19 against Edwards. Claim 1 recites:

1. A prosthetic heart valve system comprising: a prosthetic heart valve...; and a deflection device for inwardly deflecting the stent post, the deflection device including: a line interconnecting and passing through free ends of a plurality of the stent posts, a tensioning component that is movably disposed relative to free ends of the stent posts and having an end that is transitional relative to the free ends of the stent posts to a tensioning state in which the end of the tensioning component transitions the line to create tension within the line and thus to inwardly deflect at least one of the stent posts.

Claim 4 recites:

4. The prosthetic heart valve system of claim 3, wherein the tensioning component includes a tubular body slidably connected to the line, and further wherein the holder body defines an aperture sized to selectively retain the tubular body.

The parties request that the Court construe the following claim terms: "a deflection device for inwardly deflecting the stent posts, " "a line interconnecting and passing through free ends of a plurality of the stent posts, " "a tensioning component... to create tension within the line and thus to inwardly deflect at least one of the stent posts, " "movably disposed relative to free ends of the stent posts, " "an end that is transitional relative to the free ends of the stent posts, " and "tubular body slidably connected to the line."

1. "A deflection device for inwardly deflecting the stent posts"

Edwards contends that "a deflection device for inwardly deflecting the stent posts" is a means-plus-function claim under 35 U.S.C. § 112, § 6 because the language is purely functional. Alternatively, if the term is not construed as a means-plus-function term, then Edwards proposes the following construction: "A single line and a connector assembly (housing or tensioning component and locking element) that bends the stent posts inward a desired amount." Medtronic argues that the claim term requires no construction and that is not a means-plus-function claim.

"[A] claim term that does not use means' will trigger the rebuttable presumption that [35 U.S.C.] § 112 § 6 does not apply." CCS Fitness v. Brunswick Corp., 288 F.3d 1359, 1369 (Fed. Cir. 2002). "The presumption that a limitation lacking the term means' is not subject to section 112 § 6 can be overcome if it is demonstrated that the claim term fails to "recite sufficiently definite structure" or else recites "function without reciting sufficient structure for performing that function."'" Lighting World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1358 (Fed. Cir. 2004) (citation omitted). "[T]he presumption flowing from the absence of the term means' is a strong one that is not readily overcome." Id.

In arguing that the claim language is purely functional, Edwards focuses solely on the narrow phrase "deflection device for inwardly deflecting the stent posts." Edwards contends that this language is entirely functional, and that no structure for performing the function is recited. Edwards fails, however, to consider any of the words that immediately follow this phrase. The claim itself provides that the "deflection device" includes "a line interconnecting and passing through free ends of a plurality of the stent posts" and "a tensioning component that is movably disposed relative to free ends of the stent posts and having an end that is transitional relative to the free ends of the stent posts." The claim itself provides sufficient structure for performing the function of inwardly deflecting the stent posts, and so Edwards has failed to overcome the presumption that section 112, § 6 does not apply.

The Court also rejects Edwards' proposed alternative construction for this claim term. The claim itself recites the components of the deflection device-i.e., a line and a tensioning component. Edwards seeks to substitute "connector assembly" (consisting of a housing or tensioning component and locking element) for "tensioning component, " a substitution which is not supported by the specification. Notably, throughout the specification of the '929 Patent, the "locking element" is treated as distinct from the "tensioning component." See, e.g., '929 Patent figs.1-18B; id. col. 6 ll. 12-14; id. col. 11 ll. 47-49; id. col. 14 ll. 11-13; id. col. 15 ll.9-11; id. col. 17 ll. 3-5. Edwards' proposed inclusion of the word "bends" would not provide any assistance to a jury, and Edwards' requirement that the deflection be of "a desired amount" would only add more ambiguity to the claim. There is no evidence that the term "deflection device for inwardly deflecting the stent posts, " when read along with the remainder of the claim language, would be unclear to a person having ordinary skill in the art. The claim language already recites the structural components of the deflection device along with the function of the deflection device. No further construction of this claim term by the Court is necessary.

2. "A line interconnecting and passing through free ends of a plurality of the stent posts"

Edwards proposes that this term, found in claim 1 of the '929 Patent, be construed as: "a single line passing through and connecting each of the free ends of the stent posts with the others." Medtronic argues that the claim term requires no construction, or alternatively, that it be construed as "one or more lines passing through and interconnecting free ends of a plurality of the stent posts."

Edwards first notes that the patent claims and specification repeatedly refer singularly to "a line" or "the line, " and thus contends that the line must be limited to "a single line." Edwards also cites to the figures of the '929 Patent, which depict a single line passing through all of the stent posts. But as Medtronic argues, "[a]s a general rule, the words a' or an' in a patent claim carry the meaning of one or more.'" 01 Communique Lab., Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012) (internal quotation marks and citations omitted).

The exceptions to this rule are extremely limited: a patentee must evince a clear intent to limit "a" or "an" to "one." The subsequent use of definite articles "the" or "said" in a claim to refer back to the same claim term does not change the general plural rule, but simply reinvokes that non-singular meaning. An exception to the general rule arises only "where the language of the claims themselves, the specification, or the prosecution history necessitate a departure from the rule."

Id. (internal quotation marks and citations omitted). Further, "[a] patent that describes only a single embodiment is not necessarily limited to that embodiment." Saunders Grp., Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1332 (Fed. Cir. 2007). "Even where a patent describes only a single embodiment, claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope...." Id.; see also Phillips, 415 F.3d at 1323 ("[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments. In particular, we have expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment." (citations omitted)); Nazomi Commc'ns, Inc. v. ARM Holdings, PLC, 403 F.3d 1364, 1369 (Fed. Cir. 2005) (noting that claims may embrace "different subject matter than is illustrated in the specific embodiments in the specification"). Where the specification describes only a single embodiment, the claims will be read restrictively only if "the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction.'" Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002)). Here, there has been no such demonstration.

Edwards also points to the prosecution history of a related patent in support of its construction. During the prosecution of Application No. 10/336, 622, which ultimately issued as U.S. Patent No. 7, 033, 390, [3] the inventor stated:

"In particular, claim 35 provides that the tensioning component is coupled to the prosthetic heart valve via a line interconnecting the free end of each of the stent posts. Similar limitations have previously been presented in at least claim 1. Nguyen Pub. No. '686 specifically teaches at paragraph 0033 that there are at least three sutures 60 extending from the three posts 26. For at least this reason, it is respectfully submitted that newly presented dependent claim 35 recites patentable subject matter of Nguyen Pub. No. '686."

Hannah Decl. Ex. 23 at 9-10 (ECF No. 89-23). Claim 35 of the '390 Patent recited: "The prosthetic heart valve system of claim 19, wherein the tensioning component is coupled to the prosthetic heart valve via a line interconnecting the free end of each of the stent posts."[4] According to Medtronic, and undisputed by Edwards, claim 35 was never allowed by the patent examiner, despite the inventor's arguments. Moreover, the language of claims 19 and 35 of the '390 Patent is different than the language at issue in the '929 Patent-the '390 Patent language related to how the tensioning component is coupled to the valve, whereas the '929 Patent is silent regarding how the tensioning component is coupled to the valve. Thus, the prosecution history statements upon which Edwards relies were not only made during the prosecution of a different patent application, but were not critical to the issuance of any claims in any patent, and the claim language discussed during the prosecution of the '390 Patent is different than the claim language involved in the '929 Patent.

Statements made during the prosecution of a related patent may be relevant where the claim language at issue is present in both the related patent and the patent at issue. See Saunders Grp., Inc., 492 F.3d at 1333 ("The fact that the prosecution history relied upon was created in connection with the parent application would be unimportant if the claim language at issue were present in both patent applications."). But "[w]hen the purported disclaimers are directed to specific claim terms that have been omitted or materially altered in subsequent applications (rather than to the invention itself), those disclaimers do not apply." Id.; see also Ventana Med. Sys. v. Biogenex Labs., 473 F.3d 1173, 1182 (Fed. Cir. 2006) ("[T]he doctrine of prosecution disclaimer generally does not apply when the claim term in the descendant patent uses different language."). Here, the statements made during the prosecution of an unissued claim in a different patent that utilized different language than the patent at issue here does not demonstrate a clear intention to limit the claim scope of the '929 Patent claims to only devices that utilize a single line. Where there are "no words of manifest exclusion or clear disavowals of [multi-line] devices, " but instead "only preferred embodiments and goals of the inventions that... are better met by single [line] devices, " then the Court will not limit the device to a single [line] component. In re Rambus Inc., 694 F.3d 42, 47 (Fed. Cir. 2012).

The "line, " as claimed in the '929 Patent, may be constructed of multiple lines-for example, perhaps it is desirable for two or more sutures to be twisted or braided together to form the "line." However the line is created, it must "pass[] through free ends of a plurality of the stent posts" and be able to "inwardly deflect at least one of the stent posts." '929 Patent, claim 1. Absent any clear intent by the inventor to limit the claim scope to a single line, the Court does not construe "a line" to be "a single line."

During oral argument, the Court addressed the question of whether the "line, " however that line is constructed, must go through all of the stent posts or just some of the stent posts. Edwards argued that the same line must go through all of the stent posts. Medtronic, on the other hand, asserted that while some line must to go through all of the stent posts, it need not be the same line. Thus, Medtronic seems take the position that it is sufficient if the line goes through two of the three stent posts, as long as some other line goes through the remaining stent post. The claim requires that the line pass through the free ends of " a plurality of the stent posts." It does not say that the line must pass through " the plurality of the stent posts, " or in other words, all of the stent posts. Further, the claim language clearly requires that the line only must be able to deflect "at least one of the stent posts"-it is unclear how it could deflect fewer than all of the stent posts if it were required to pass through all of the stent posts, since it appears as though in that configuration, any tension applied to the line would inwardly deflect all of the posts. And while the figures of the '929 Patent depict the same line passing through all of the stent posts, it is inappropriate for the Court to import such a limitation into the claim language absent a clear demonstration that the inventor so intended. The Court therefore rejects Edwards argument. Edwards seems to suggest that if the "line" may be comprised of more than one line, and if the same line need not go through all of the stent posts, then the invention is anticipated by the prior art. If that is the case, then that may be a question for another day. But for the moment, based on the record before the Court, no construction of this claim term is required.

3. "A tensioning component... to create tension within the line and thus to inwardly deflect at least one of the stent posts"

Claim 1 recites "a tensioning component that is movably disposed relative to free ends of the stent posts and having an end that is transitional relative to the free ends of the stent posts to a tensioning state in which the end of the tensioning component transitions the line to create tension within the line and thus to inwardly deflect at least one of the stent posts." Edwards argues that section 112, § 6 applies because the language is purely functional and that the claim does not recite sufficient structure to perform the function. Alternatively, if the Court determines that section 112, § 6 does not apply, Edwards proposes the following construction: "a component that can create tension in a line where previously there was none such that at least one stent post bends inwards a desired amount." Medtronic asserts that the claim term requires no construction and that it is not a means-plus-function term. Because the claim term does not use the word "means, " there is a strong rebuttable presumption that section 112, § 6 does not apply. CCS Fitness, 288 F.3d at 1369. As previously stated, this presumption can be overcome if the claim fails to recite sufficiently definite structure, or does not recite sufficient structure for performing the stated function. See Lighting World, 382 F.3d at 1358.

There is no evidence that the term "tensioning component" has a generally understood structural meaning in the art. In the absence of any other claim language providing structure, this would weigh in favor of applying section 112, §6. See Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206 (Fed. Cir. 1998). But other claim language that provides the necessary structure will save the claim from application of section 112, § 6. Id. at 1213; see also Mass. Inst. of Tech. & Elec. for Imaging, Inc. v. Abacus Software, 462 F.3d 1344, 1354 (Fed. Cir. 2006) ("Claim language that further defines a generic term like mechanism' can sometimes add sufficient structure to avoid 112 § 6."). Here, the claim does not merely recite "a tensioning component" that performs the function of creating tension on the line. Rather, the claim provides that the tensioning component "is movably disposed relative to free ends of the stent posts" and has "an end that is transitional relative to the free ends of the stent posts" so that "the tensioning component transitions the line to create tension within the line and thus to inwardly deflect at least one of the stent posts." This is more than purely functional language and provides sufficient structure to avoid the application of section 112, § 6. See, e.g., Lighting World, 382 F.3d at 1359-63 (finding that the claim language "a connector assembly for connecting each pair of adjacent support members, said connector assembly being pivotally connected to said pair of adjacent support members" provided sufficient structure to avoid application of section 112, § 6); DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1023 (Fed. Cir. 2006) (finding that "a compression member for exerting a force onto said head such that said head is pressed against the hollow spherically-shaped portion" recited sufficient structure because the claim language "demonstrates that the compression member must fit inside the cylindrical opening and be of sufficient size to exert a force on the screw head, which implies structure").[5]

Further, it is clear from the specification that the term "tensioning component" denotes a structure, rather than just a function. See Lighting World, 382 F.3d 1354, 1361 (Fed. Cir. 2004) (relying in part on the fact that the written description used the term "connector assembly" as the name for a structure, and did not use the term in a purely functional manner, to hold that the claim was not subject to § 112, § 6); DePuy Spine, 469 F.3d at 1023 (explaining that the specification made "clear that the term compression member' refers to a particular cylindrical insert and is not simply a general reference to any structure that will perform a particular function"). Throughout the '929 Patent, the phrase "tensioning component" is used to denote structure. See, e.g., '929 Patent col. 3 ll. 49-53 (stating that the connector assembly includes "a tensioning component" and that the line that interconnects and passes through the stent posts is connected to the tensioning component). Moreover, each figure depicts the "tensioning component" as a definite structure-as an identifiable part of the connector assembly. Notably, in relation to some embodiments, the '929 Patent repeatedly uses the phrases "housing" and "tensioning component" synonymously. See, e.g., id. col. 6 ll. 13 ("housing or tensioning component 60"); id. col. 11 ll. 48 ("housing or tensioning component 126"). The word "housing" has a structural meaning, i.e., "something that covers or protects: as a: a case or enclosure (as for a mechanical part or an instrument) b: a casing (as an enclosed bearing) in which a shaft revolves c: a support (as a frame) for mechanical parts." Merriam-Webster's Collegiate Dictionary 562 (10th ed. 2001). It is not a generic term such as "mechanism, " "means, " element, " or "device." Cf. Mass. Inst. of Tech. & Elec. for Imaging, Inc. v. Abacus Software, 462 F.3d 1344, 1354 (Fed. Cir. 2006) (noting that such generic terms "typically do not connote sufficiently definite structure").

This case is unlike Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206 (Fed. Cir. 1998), the case upon which Edwards relies, because "[i]n that case, no other claim terms attributed structural significance to the elements at issue, and there was no evidence that the term at issue had an understood structural meaning in the art." DePuy Spine, 469 F.3d at 1024; see also Lighting World, 382 F.3d at 1362 (describing Mas-Hamilton as an "exceptional case" and stating that "we have seldom held that a limitation not using the term means' must be considered to be in means-plus-function form"). Here, the claim language itself provides structure, and the specification makes clear that a "tensioning component" is some definite structure, rather than just any structure that will create tension.

Having found that "tensioning component" is not subject to section 112, § 6, the Court next considers whether any construction of this claim term is necessary. Edwards argues that there must be no preexisting tension in the line in order for the tensioning component to "create" tension. Edwards focuses on the figures in the '929 Patent, which depict some slack in the line when the device is in the untensioned state. But the fact that the figures depict slack does not mean that there must always be slack prior to the creation of tension by the tensioning component. As previously explained, "[a] patent that describes only a single embodiment is not necessarily limited to that embodiment." Saunders Grp., 492 F.3d at1332. "Even where a patent describes only a single embodiment, claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope...." Id. Nothing in the claim language, specification, or file history precludes preexisting tension in the line, and there is certainly no demonstration of a clear intention to limit the claim scope to devices that create tension only in lines where there was no preexisting tension.

Edwards next points to a dictionary definition of "create, " which defines "create" as "to cause to come into being." Hannah Decl. Ex. 24 at 472 (ECF No. 89-24). Edwards argues that to give effect to the word "create, " the device must cause something to come into existence that previously did not exist-thus, according to Edwards, there must be no preexisting tension. The Court disagrees. It is true that the tensioning component must "create" tension-that is, it must create new tension, where said newly created tension did not previously exist. And the newly created tension must be sufficient "to inwardly deflect at least one of the stent posts." '929 Patent, claim 1. But the fact that the tensioning component must bring about new tension says nothing about what tension, if any, already existed in the line. For example, there may be some preexisting tension on the line if the surgeon sutures the line tightly so that there is no slack in the line, but not tightly enough to produce sufficient tension to inwardly deflect the stent posts. In that scenario, the tensioning component may still create sufficient new tension to cause the stent posts to inwardly deflect. The Court is not persuaded that in order for the tensioning component to "create" tension within the line, there must be no preexisting ...


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