Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

QXMedical, LLC v. Vascular Solutions, LLC

United States District Court, D. Minnesota

October 2, 2019

QXMÉDICAL, LLC, Plaintiff,
v.
VASCULAR SOLUTIONS, LLC; TELEFLEX INNOVATIONS S.À.R.L.; and ARROW INTERNATIONAL, INC., Defendants.

          Courtland C. Merrill and Philip J. Kaplan, ANTHONY OSTLUND BAER & LOUWAGIE P.A., for plaintiff.

          J. Thomas Vitt, Emily Justine Tait, Patrick J. O'Rear, and Sanjiv Prakash Laud, JONES DAY; Kenneth E. Levitt, DORSEY & WHITNEY, for defendants.

          ORDER

          Patrick J. Schiltz United States District Judge

         This lawsuit involves six patents-U.S. Patent Nos. 8, 048, 032 (the “‘032 patent”), 8, 142, 413 (the “‘413 patent”), RE45, 380 (the “RE'380 patent”), RE45, 760 (the “RE'760 patent”), RE45, 776 (the “RE'776 patent”), and RE46, 116 (the “RE'116 patent”). All six patents descend from a common patent application and share a common specification and common drawings. The patents are owned by defendant Teleflex Innovations S.à.r.l., whose parent corporation acquired defendant Vascular Solutions, LLC, in February 2017. A third defendant, Arrow International, Inc., has the right to sell products practicing the patents. For convenience, the Court will refer to the defendants collectively as “Vascular Solutions.”

         In April 2017, Vascular Solutions accused plaintiff QXMédical, LLC of patent infringement. In response, QXMédical brought this action, seeking a declaration that its Boosting Catheter does not infringe any of Vascular Solutions's patents and that Vascular Solutions's patents are invalid. Vascular Solutions counterclaimed, seeking judgment against QXMédical for infringement.

         On October 30, 2018, the Court issued an order construing certain terms of the patents in suit pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 390-91 (1996). See QXMédical, LLC v. Vascular Solutions, No. 17-CV-1969 (PJS/TNL), 2018 WL 5617568, at *1 (D. Minn. Oct. 30, 2018). After the close of discovery, the parties filed cross-motions for summary judgment. For the reasons that follow, the Court mostly grants Vascular Solutions's motion, and mostly denies QXMédical's motion.

         I. BACKGROUND

         The Court will assume familiarity with its Markman order. Very briefly, the patents in suit relate to a medical device known as a “guide extension catheter.” A guide extension catheter is used by a heart surgeon to deliver a balloon or stent into a coronary artery that has been narrowed by a buildup of plaque. The surgeon pushes the guide extension catheter though a larger catheter (known as the “guide catheter”), and then pushes the balloon or stent through the guide extension catheter and into the coronary artery.

         The GuideLiner catheter that Vascular Solutions manufactures is depicted in the following diagram:

         (Image Omitted)

         ECF No. 125-22 at 32.[1] The GuideLiner catheter manufactured by Vascular Solutions-as well as the Boosting Catheter manufactured by QXMedical-are composed of three main parts: (1) a pushrod, (2) a side opening, and (3) a flexible tip. In this diagram, the pushrod is on the left, the side opening is in the middle (within the blue section), and the flexible tip is on the right (in yellow).

         II. DISCUSSION

         A. Standard of Review

         Summary judgment is warranted “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). A dispute over a fact is “material” only if its resolution might affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute over a fact is “genuine” only if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id. When considering a summary-judgment motion, the Court “must view the evidence and the inferences that may be reasonably drawn from the evidence in the light most favorable to the non-moving party.” Winthrop Res. Corp. v. Eaton Hydraulics, Inc., 361 F.3d 465, 468 (8th Cir. 2004).

         B. Validity-Indefiniteness of “Substantially Rigid”

         All of the claims asserted against QXMédical disclose a “substantially rigid” segment, which is informally referred to as the “pushrod.” QXMédical argues that these claims are fatally indefinite because of the way that the Court defined “substantially rigid” in its Markman order. Both parties have moved for summary judgment on the issue.

         “A claim is invalid for indefiniteness if its language, when read in light of the specification and the prosecution history, ‘fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.'” Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1377 (Fed. Cir. 2015) (citation omitted). Because a patent is presumed to be valid, an accused infringer must prove indefiniteness by clear and convincing evidence. See Microsoft Corp. v. i4i Ltd. P'ship, 564 U.S. 91, 95 (2011). Summary judgment may be granted on the issue of indefiniteness when there is no genuine dispute as to any material fact. See Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1336 (Fed. Cir. 2016) (affirming a district court's grant of summary judgment that a patent is not invalid for indefiniteness).

         In its Markman order, the Court adopted a functional definition of “substantially rigid, ” construing the term to mean “rigid enough to allow the device to be advanced within the guide catheter.” QXMédical, 2018 WL 5617568, at *5. QXMédical does not actually argue that the term (as defined by the Court) is indefinite. In other words, QXMédical does not argue that a person of ordinarily skill in the art would have any difficulty determining whether a particular portion of a guide extension catheter is rigid enough to push a flexible tubular structure through a guide catheter.

         Rather, QXMédical argues that the problem with the Court's definition is that a portion of a guide extension catheter could be both “substantially rigid” and “flexible.” Specifically, QXMédical contends that the material that comprises the tip portion (which must be “flexible”) might be “rigid enough to allow the device to be advanced within the guide catheter” (and thus also “substantially rigid”). Likewise, the pushrod (which must be “substantially rigid”) must be able to bend enough to navigate the vascular system of a human being (and thus must also be “flexible”). Under the Court's definition, says QXMédical, a person of ordinary skill would be unable to distinguish the “substantially rigid” portion of the device from the “flexible” portion.

         The problem with QXMédical's argument is that its premise is flawed: Nothing in any of the patents in suit says that “substantially rigid” and “flexible” are mutually exclusive. In other words, nothing in any of the patents says that a segment of the device cannot be both “substantially rigid” and “flexible.” Instead, the claims that disclose a “flexible tip” portion simply require that the substantially-rigid pushrod be “more rigid” than the flexible tip. See, e.g., ‘032 at 10:38-40 (emphasis added). This is a comparative limitation-a limitation that would be superfluous if “substantially rigid” and “flexible” were mutually exclusive categories. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are interpreted with an eye toward giving effect to all terms in the claim.”).

         QXMédical's argument that “substantially rigid” and “flexible” are mutually exclusive is also belied by its own proposed constructions of those terms. During the Markman proceedings, QXMédical asked the Court to define “substantially rigid” as “largely, but not wholly unable to bend, ” and “flexible” as “capable of bending.” ECF No. 56 at 21. Obviously something that is ”largely, but not wholly unable to bend” (and thus “substantially rigid” as QXMédical would define that term) is also “capable of bending” (and thus “flexible” as QXMédical would define that term). In other words, under QXMédical's own proposed definitions, anything that is “substantially rigid” would necessarily be “flexible” as well.

         There is, at bottom, no evidence in the record supporting QXMédical's argument that a person of ordinary skill would be unable to distinguish between the “substantially rigid” pushrod and the “flexible” distal tip. The experts on both sides agree that a person of ordinary skill would have no trouble determining whether a pushrod is “rigid enough to allow the device to be advanced within the guide catheter.” See ECF No. 134-2 at 4-5; ECF No. 137 at 31-32. And the experts on both sides agree that a person of ordinary skill would have no difficulty determining whether a substantially rigid pushrod is “more rigid” than a flexible tip portion. ECF No. 134-2 at 6; ECF No. 137 at 31-33.[2]

         Because there is no evidence-much less clear and convincing evidence-that the boundaries of the claims cannot be understood by a person of ordinary skill, the Court grants Vascular Solutions's motion for summary judgment on the issue of indefiniteness.

         C. Validity-Recapture Rule

         The ‘032 patent claims a pushrod “without a lumen.” Three of the reissued patents-the RE'760, RE'776, and RE'116 patents-do not include this limitation, however, and thus those reissued patents claim pushrods that have lumens, as well as pushrods that do not. The parties dispute whether, by removing the “without a lumen” limitation from the reissued patents, Vascular Solutions violated the “recapture rule” and thereby rendered those patents invalid.

         The recapture rule “prevents a patentee from regaining through reissue the subject matter that he surrendered in an effort to obtain allowance of the original claims.” In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997). “To decide whether a patentee surrendered certain subject matter, [courts] must determine ‘whether an objective observer viewing the prosecution history would conclude that the purpose of the patentee's amendment or argument' . . . [was] ‘to overcome prior art and secure the patent.'” Greenliant Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1267 (Fed. Cir. 2012) (quoting Kim v. ConAgra Foods, Inc., 465 F.3d 1312, 1323 (Fed. Cir. 2006)). A reissued claim is invalid if it violates the rule against recapture. MBO Labs., Inc. v. Becton, Dickinson & Co., 602 F.3d 1306, 1313 (Fed. Cir. 2010). Whether a reissued claim violates the recapture rule is a question of law. Medtronic, Inc. v. Guidant Corp., 465 F.3d 1360, 1373 (Fed. Cir. 2006).

         Courts follow a three-step inquiry when deciding if a patentee has violated the recapture rule:

“(1) first, we determine whether, and in what respect, the reissue[d] claims are broader in scope than the original patent claims; (2) next, we determine whether the broader aspects of the reissue[d] claims relate to subject matter surrendered in the original prosecution; and (3) finally, we determine whether the reissue[d] claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.”

Greenliant Sys., 692 F.3d at 1267 (quoting N. Am. Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1349 (Fed. Cir. 2005)). “[T]he recapture rule applies only if the patentee surrendered subject matter in the original prosecution in order to overcome a prior art rejection.” Cubist Pharm., Inc. v. Hospira, Inc., 805 F.3d 1112, 1121 (Fed. Cir. 2015).

         Here, the parties agree that the reissued claims are broader in scope than the original claims, as the reissued claims capture all pushrods, and not just pushrods without a lumen (step one). The parties also agree that the reissued claims were not materially narrowed in other respects, such that the overall scope of the reissued claims is not broader than the original claims (step three). The parties disagree about step two. Specifically, the parties dispute whether Vascular Solutions added the “without a lumen” limitation during the prosecution of the ‘032 patent “in order to overcome a prior art rejection.” Id.

         There is no factual dispute about the history of the ‘032 patent's prosecution: In May 2006, Vascular Solutions sought a patent for a guide extension catheter with a pushrod described as a “substantially rigid portion.” ECF No. 125-3 at 27. This patent would have covered pushrods with and without lumens. The examiner denied the application as obvious in light of prior art. Specifically, the examiner concluded that the claims were “unpatentable over Niazi . . . in view of Solar.” ECF No. 125-4 at 3. Solar discloses a rapid exchange balloon catheter with a pushrod “formed of a flexible wire, or, alternately, of spring hollow hypotubing.” ECF No. 125-18 at 12. Thus, the prior art cited by the examiner included both a pushrod with a lumen (the Solar embodiment with hypotubing, see ECF No. 125-2 at 23 (describing a hypotube as a “hollow metal shaft”)), and a pushrod without a lumen (the Solar embodiment with the wire pushrod, ECF No. 134-2 at 4).

         In February 2010, Vascular Solutions filed new claims describing its pushrod as “an elongated structure . . . having a non-circular cross-section.” ECF No. 125-9 at 4, 19. The examiner rejected those claims because they failed to comply with the written- description requirement, 35 U.S.C. § 112(a), and they were obvious in light of prior art, ECF No. 125-10. The examiner wrote that “it would have been an obvious matter of design choice to a person of ordinary skill to modify [Solar's pushrod] to be non-circular . . . because a non-circular cross-section would have the ability to perform the same function as the rod taught by Solar with only the expected result of minimizing the profile of the rod inside the device.” ECF No. 125-10 at 7.

         In response, Vascular Solutions requested a continued examination and amended the proposed claim language to cover “non-tubular” and “non-circular” pushrods. ECF No. 125-11 at 7, 10. The examiner rejected the amendment as obvious and because it lacked an adequate written description. ECF No. 125-12.

         In February 2011, Vascular Solutions amended its claims yet again, this time describing the pushrod as “more rigid . . . than[] the flexible tip portion.” ECF No. 125-15 at 9, 22. In response, the examiner proposed an amendment describing the pushrod as a “rail structure without a lumen.” Vascular Solutions accepted the proposal, and the examiner finally allowed the application. ECF No. 125-16. The examiner explained that he allowed the application because “the arrangement of a claimed rail structure with the claimed flexible tip that is insertable through a hemostatic valve is not taught or suggested by the prior art.” Id. at 7.

         The question for this Court is whether this prosecution history provides clear and convincing evidence that Vascular Solutions surrendered pushrods that have lumens in order to overcome a prior-art rejection. The complication, of course, is that the “without a lumen” limitation was proposed by the examiner, not Vascular Solutions. The examiner did not explain why he proposed that particular limitation, and Vascular Solutions did not explain why it accepted the limitation. Moreover, whatever the motivations of the examiner and Vascular Solutions, it is absolutely clear that the “without a lumen” limitation was not in fact necessary to overcome the prior art, as Solar disclosed pushrods without lumens.

         QXMédical nevertheless argues that Vascular Solutions surrendered pushrods that have lumens in order to overcome a prior-art rejection. In support of its argument, QXMédical cites language in the Manual of Patent Examining Procedure (“the manual”) addressing the following situation: Suppose that a patent application claims Aߠ. Suppose further that the examiner denies the application because the prior art already discloses Aߠ. If the applicant adds limitation D to Aߠ without explaining why-and if the application gets approved-then, according to the manual, “it must be presumed that the D limitation was added to obviate the rejection” even if “there is no argument as to the addition of limitation D.” M.P.E.P § 1412.02.

         According to QXMédical, the hypothetical case described in the manual is materially identical to the facts of this case. Vascular Solutions submitted a patent application claiming all pushrods. The examiner denied the application. Vascular Solutions then added the “without a lumen” limitation at the examiner's suggestion, without any explanation as to why such a limitation was necessary. The application was approved. And thus, argues QXMédical, the manual directs the Court to presume that the “without a lumen” limitation was added to overcome prior art.

         The Court has its doubts, as QXMédical's argument overlooks the fact that the hypothetical case described in the manual is distinguishable from this case in one crucial respect: In the hypothetical case described in the manual, the D limitation added a limitation that was not taught by the prior art. Here, however, the “without a lumen” limitation was taught by the prior art. It makes no sense to presume that the “without a lumen” limitation was added to overcome prior art, when it is clear that the prior art disclosed a pushrod without a lumen. See ECF 134-2 at 4 (QXMédical's expert agreeing that Solar disclosed a pushrod without a lumen).

         The Court will nevertheless assume (for the sake of argument) that QXMédical is correct and that the manual's so-called “presumption of surrender” applies. That presumption is not dispositive, but is instead rebuttable.[3] The Court finds that there is ample evidence in the prosecution history to rebut the presumption:

         First, as the Court has already explained, no rational patent examiner could have believed that the “without a lumen” limitation was necessary to overcome prior art. The examiner was intimately familiar with Solar, [4] and Solar clearly and undisputedly discloses a pushrod without a lumen. If the patent examiner was competent (as he is presumed to be[5]), he could not possibly have suggested adding “without a lumen” to escape prior art.

         Second, in trying to discern the reason for the examiner's proposed amendment, the Court need not apply a presumption because the examiner explained the reason why he allowed the amended application: “While many of the structures are known, the arrangement of a claimed rail structure with the claimed flexible tip that is insertable through a hemostatic valve is not taught or suggested by the prior art.” ECF No. 125-16 at 7. This explanation is admittedly vague in some respects, but it is clear on one point: The addition of the “without a lumen” limitation had nothing to do with ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.