Case 1:21-cv-01377-JPM Document 25 Filed 04/21/22 Page 1 of 11 PageID #: 1802
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`UNITED STATES DISTRICT COURT
`DISTRICT OF DELAWARE
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`AORTIC INNOVATIONS, LLC,
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`Plaintiff,
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`v.
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`EDWARDS LIFESCIENCES
`CORPORATION; EDWARDS
`LIFESCIENCES LLC; EDWARDS
`LIFESCIENCES (U.S.) INC.,
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`Defendants.
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`Case No. 1:21-cv-01377-JPM
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`JURY TRAL DEMANDED
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`ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ RULE
`12(b)(6) MOTION TO DISMISS
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`Before the Court is Defendants Edwards Lifesciences Corporation, Edwards Lifesciences
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`LLC, and Edwards Lifesciences (U.S.) Inc.’s (collectively, “Edwards”) 12(b)(6) Motion to
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`Dismiss, filed on December 6, 2021. (ECF No. 10.) For the following reasons, the Court
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`GRANTS IN PART and DENIES IN PART Edwards’s Motion.
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`I.
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`BACKGROUND
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`A.
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`Factual Background
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`Plaintiff Aortic Innovations, LLC (“Aortic” or “AI”) is incorporated in Florida, with a
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`principal place of business in Hillsboro Beach, Florida. (ECF No. 1 ¶ 7.) Edwards is incorporated
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`in Delaware, with a principal place of business in Irvine, California. (Id. ¶¶ 8–10.) Edwards sells
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`the SAPIEN 3 Ultra TAVR (transcatheter aortic valve replacement), which Aortic alleges infringes
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`one or more claims of the following of its patents: U.S. Patent No. 10,881,538 (the “’538 Patent”),
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`U.S. Patent No. 10,966,846 (the “’846 Patent”), U.S. Patent No. 10,987,236 (the “’236 Patent”),
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`and U.S. Patent No. 11,129,735 (the “’735 Patent”). (Id. ¶¶ 103–69.)
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`1
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`Case 1:21-cv-01377-JPM Document 25 Filed 04/21/22 Page 2 of 11 PageID #: 1803
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`The patents are directed to an improvement in TAVR devices. The Complaint provides a
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`general summary of TAVR:
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`TAVR is a procedure where a replacement aortic heart valve is delivered by a
`catheter through an artery of a patient. Prior to TAVR, patients undergoing heart
`valve replacement would have their chest incised in an open heart procedure called
`Surgical Aortic Valve Repair (“SAVR”). SAVR often led to increased
`complications and was not deemed suitable for high risk patients who were often
`determined to be inoperable. The first TAVR device was approved in the United
`States by the Food and Drug Administration in 2011. Since that time, TAVR has
`become the leading choice for aortic valve replacement compared to the SAVR
`approach, with the number of TAVR procedures exceeding the number of SAVR
`procedures for the first time in 2019.
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`(Id. ¶ 3.) The claims of the Asserted Patents and the accused product are improvements of the
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`original TAVR devices.
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`B.
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`Procedural Background
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`On September 28, 2021, Aortic filed a Complaint accusing Edwards of infringing its
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`patents. (ECF No. 1.) Edwards filed a Motion to Dismiss (ECF No. 10) and an Opening Brief in
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`Support (ECF No. 11) on December 6, 2021. Aortic filed a Response in Opposition on December
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`20, 2021. (ECF No. 13.) Edwards filed a Reply on January 3, 2022. (ECF No. 16.) The Court
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`held a hearing on the Motion on March 10, 2022. (ECF No. 23.)
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`II.
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`LEGAL STANDARD
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`When reviewing a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6),
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`the Court must accept the complaint’s factual allegations as true. See Bell Atl. Corp. v. Twombly,
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`550 U.S. 544, 555–56 (2007). “Though ‘detailed factual allegations’ are not required, a complaint
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`must do more than simply provide ‘labels and conclusions’ or ‘a formulaic recitation of the
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`elements of a cause of action.’” Davis v. Abington Mem’l Hosp., 765 F.3d 236, 241 (3d Cir.
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`2014) (quoting Twombly, 550 U.S. at 555). A complainant must plead facts sufficient to show
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`that a claim has “substantive plausibility.” Id. at 247. That plausibility must be found on the face
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`of the complaint. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
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`III. ANALYSIS
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`A.
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`Pre-Suit Knowledge of the ’735 Patent
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`For willful and induced infringement, the plaintiff must allege that the defendant had
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`knowledge of the patent. See Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964, 988 (Fed. Cir.
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`2021) (“Knowledge of the asserted patent and evidence of infringement is necessary, but not
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`sufficient, for a finding of willfulness.”); Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632,
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`639 (2015) (“[L]iability for inducing infringement attaches only if the defendant knew of the patent
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`and that ‘the induced acts constitute patent infringement.’”) (quoting Global-Tech Appliances, Inc.
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`v. SEB S.A., 563 U.S. 754, 766 (2011)).
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`Edwards contends that Aortic’s Complaint fails to state a claim for willful and indirect
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`infringement of the ’735 Patent “because AI fails to allege facts supporting a plausible inference
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`that Edwards had pre-suit knowledge of the ’735 [P]atent, which issued on the same day that AI
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`filed its Complaint in this action.” (ECF No. 11 at PageID 1331.) Edwards contends that “[t]his
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`Court recently dismissed willful infringement claims under similar circumstances in Express
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`Mobile, Inc.” because, in that case, “the patentee provided the defendant with express notice of the
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`patent one day before filing its complaint.” (Id. at PageID 1334.) (citing Express Mobile, Inc. v.
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`Squarespace, Inc., No. 20-1163-RGA, 2021 WL 3772040, at *5 (D. Del. Aug. 25, 2021).) Edwards
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`points out that “[u]nlike defendants in Express Mobile, Inc., Edwards did not even receive one-
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`day advance notice of the ’735 patent’s existence and alleged infringement.” (Id.)
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`Edwards also contends that the email sent from Dr. Shahriari (founder of Aortic and
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`inventor of the patents-in-suit), informing Edwards of potentially infringing activity and listing the
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`other patents-in-suit, “does not plausibly support AI’s willful infringement allegations” because it
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`“does not include the ’735 patent in the list of AI’s patents, nor could it have, because the ’735
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`patent did not issue for more than two months after the email was sent.” (Id.) Edwards contends
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`that these facts are similar to the dismissed allegations of willful infringement in Wrinkl, Inc.
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`because in that case, the patent in question “did not issue until July 2020” even though the pre-suit
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`knowledge was alleged to come from “an October 2018 email exchange.” (Id. at PageID 1335.)
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`(citing Wrinkl, Inc. v. Facebook Inc., No. 20-cv-1345-RGA, 2021 WL 4477022, at *6 (D. Del.
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`Sept. 30, 2021).)
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`In response, Aortic contends that the email from Dr. Shahriari does provide sufficient
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`notice because “[t]hat email listed the patent number for three of the four Patents-in-Suit as well
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`as the publication number for the application that was set to issue shortly as the fourth—the ’735
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`Patent.” (ECF No. 13 at PageID 1360.) Aortic contends that pre-suit knowledge of the ’735 Patent
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`is pled when considered under the totality of the circumstances. (Id. at PageID 1361.) Aortic
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`asserts that “case law further indicates that, within this totality of circumstances, parties can have
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`knowledge of a patent prior to patent issuance—in particular, they can have relevant pre-suit
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`knowledge of patent claims following a notice of allowance from the PTO.” (Id.) (citing WCM
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`Indus., Inc. v. IPS Corp., 721 F. App’x 959, 973 (Fed. Cir. 2018).) Aortic contends that “it is
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`highly likely—and most certainly plausible—that Edwards discovered the USPTO’s August 23,
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`2021 final notice of allowance prior to the filing of this suit on September 28, 2021.” (Id. at PageID
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`1363.)
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`On Reply, Edwards contends that “even where a notice of allowance has been entered, the
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`claims of an application can still be amended and further prosecuted.” (ECF No. 16 at PageID
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`1561.) (citing 37 C.F.R. §§ 1.312, 1.114.) Edwards points out that “there were three separate
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`notices of allowance entered for the ’735 patent’s application before it ultimately issued, and AI
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`amended the claims after the first notice of allowance was entered.” (Id.) Edwards further
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`contends that “AI does not cite a single case holding that knowledge of a patent application is
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`sufficient to support a plausible inference of pre-suit knowledge of an issued patent.” (Id. at
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`PageID 1562.)
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`In Wrinkl, this Court found that the complaint plausibly alleged pre-suit knowledge from
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`an email from the plaintiff to the defendant where the patent had been listed in a video presentation
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`that was linked in the email. 2021 WL 4477022, at *5–6. The Court found that this email
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`correspondence was insufficient, however, to plausibly allege pre-suit knowledge of the other
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`patent-in-suit because that patent did not issue until nearly two years after the email was sent. Id.
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`Here, while the time between issuance of the ’735 Patent and the email from Dr. Shahriari is just
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`over a month, the email only listed the patent application, and as such, does not necessarily provide
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`knowledge of the patent.
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`The Eastern District of Texas has held that knowledge of a patent application was sufficient
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`to allege pre-suit knowledge of the patent itself because at the time the defendant had knowledge
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`of the patent application, the patent itself had already issued. See Blitzsafe Tex., LLC v.
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`Volkswagen Grp. of Am., Inc., No. 2:15-cv-1274-JRG-RSP, 2016 WL 4778699, at *6 (E.D. Tex.
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`Aug. 19, 2016) (“The Court finds VWGoA could have learned of the ’786 patent when it cited the
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`Marlowe Application in a Patent Office proceeding. The proceeding occurred a year after the ’786
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`patent issued.”), report and recommendation adopted, 2016 WL 4771291 (E.D. Tex. Sept. 13,
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`2016). Further, the Federal Circuit has indicated that it may be possible to have pre-suit knowledge
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`of a patent before the patent issues. See WCM Indus., 721 F. App’x at 970 (“[H]ere, WCM
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`provided sufficient evidence for a reasonable jury to conclude that IPS did know of WCM’s patents
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`as they issued, if not earlier.”). In that same case, though, the Federal Circuit declined to decide
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`whether a party can have knowledge pre-issuance because the patents-in-suit had issued before the
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`lawsuit was filed. See id. at 970 n.4 (“Because we conclude that WCM provided sufficient
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`evidence . . . that IPS did know of WCM’s patents at least when they issued, which was before the
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`lawsuit was initiated . . ., we need not decide whether the cases cited by IPS still support its
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`argument.”). At the hearing, Aortic acknowledged that there is no existing case law that has
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`allowed an allegation of pre-suit knowledge for a patent that issued the same day or after a
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`complaint was filed. (Hearing Tr., ECF No. 23 at PageID 1728.)
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`The Complaint alleges that Edwards had knowledge of the patents-in-suit from the email
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`sent by Dr. Shahriari, which does not list (nor could it have listed) the ’735 Patent. (ECF No. 1 at
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`¶ 55.) The Complaint does not allege facts that plausibly state that Edwards was aware of the
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`notice of allowance, and further, as discussed by Edwards in its briefs, there is no case that has
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`found pre-suit knowledge of a patent before it has issued. As such, it is not plausible that Edwards
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`had pre-suit knowledge of the ’735 Patent. Edwards’s Motion as to indirect and willful
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`infringement of the ’735 Patent is GRANTED.
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`B.
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`Direct Infringement
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`Edwards contends that “AI fails to allege facts supporting a plausible inference that
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`Edwards directly infringes at least one claim of the patents because AI fails to allege how
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`Edwards’[s] SAPIEN 3 Ultra meets several limitations of the patents.” (ECF No. 11 at PageID
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`1336.) Edwards contends that AI fails to allege that the SAPIEN 3 Ultra has the “inner frame”
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`limitation that is required in every claim from the asserted patents, that AI fails to allege that the
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`SAPIEN 3 Ultra has the “second portion” of non-metallic fibers required in the claims of the ’236
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`Patent, and that AI fails to allege that Edwards’s employees directly perform the method claims of
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`the ’538 Patent. (Id. at PageID 1336, 1340–41.)
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`Aortic contends that “Edwards’s request for an in-depth, element-by-element infringement
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`analysis is akin to a request for infringement contentions—such specificity is not required at the
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`pleading stage.” (ECF No. 13 at PageID 1366.) Aortic further contends that “Edwards’s
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`arguments also invite the Court to make factual findings about the structure of the accused product
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`and claim construction rulings on a number of claim terms—all of this is inappropriate on a motion
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`to dismiss.” (Id.)
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`1. The “inner frame” and “second portion” limitations
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`Edwards asserts that “[e]very claim of the Asserted Patents recites a valve assembly that
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`must include at least two frames: (1) a metallic ‘outer frame’ and (2) an ‘inner frame’ that includes
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`a graft covering,” and that “the Complaint does not identify any component of SAPIEN 3 Ultra
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`that allegedly satisfies the distinct ‘inner frame’ limitation, nor does it include any explanation of
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`how SAPIEN 3 Ultra allegedly includes such a frame.” (ECF No. 11 at PageID 1336–37.)
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`Edwards contends that “AI fails to provide any . . . annotated images identifying the ‘inner frame,’”
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`and “[i]nstead, AI merely cites to two exhibits, . . . then summarily concludes that SAPIEN 3 Ultra
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`includes an inner frame ‘on information and belief.’” (Id. at PageID 1338.) Edwards contends
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`that “without any explanation for how SAPIEN 3 Ultra allegedly meets the ‘inner frame’
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`limitation, the Complaint does not provide Edwards with reasonable notice of ‘what activity is
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`being accused of infringement.’” (Id. at PageID 1339.) (quoting Uniloc 2017 LLC v. Zenpayroll,
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`Inc., No. 19-1075-CFC-SRF, 2020 WL 4260616, at *3 (D. Del. July 23, 2020).)
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`Similarly, for the “second portion” of non-metallic fibers limitation in each claim of the
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`’236 Patent, Edwards contends that “the Complaint merely recites the claim language and repeats
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`the conclusory statement that SAPIEN 3 Ultra includes a ‘second portion of fibers’ ‘[o]n
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`information and belief,’” and “then provides an unannotated image of a SAPIEN 3 Ultra valve
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`without identifying or explaining which aspect(s) of the valve allegedly corresponds to the ‘second
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`portion of fibers.’” (Id. at PageID 1340.)
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`In response, Aortic contends that the Complaint meets the Twombly/Iqbal pleading
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`requirements for the “inner frame” limitation because it “alleges that the Sapien 3 Ultra has an
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`inner frame and links to two additional FDA documents for evidentiary support,” and “[i]t further
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`alleges that this inner frame includes a graft covering and cites for support an image from
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`Edwards’s website.” (ECF No. 13 at PageID 1368.) Similarly, Aortic contends that the Complaint
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`“alleges that the Sapien 3 Ultra has first and second portions of non-metallic fibers, offering two
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`images showing the portions.” (Id.) Aortic also contends that “Edwards’s insistence that it
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`requires more specificity regarding Aortic’s theories on the ‘inner frame’ and ‘second portion’
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`elements effectively reduces to a request for infringement contentions—a request that is untimely
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`and improper at this stage of the case.” (Id. at PageID 1370.) Aortic argues that “Edwards’s
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`arguments further invite the Court to engage in fact finding and claim construction, which are both
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`inappropriate at this stage.” (Id. at PageID 1371.) As an example, Aortic contends that Edwards
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`is “ask[ing] this Court to construe Aortic’s claims such that ‘inner frame’ is a distinct structure
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`from the ‘graft covering.’” (Id.)
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`On Reply, Edwards contends that “AI fails to allege plausible facts that SAPIEN 3 Ultra
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`includes an ‘inner frame’ under any construction of that term.” (ECF No. 16 at PageID 1567.)
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`“To plead direct infringement, a plaintiff must allege facts ‘that plausibly indicate that the
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`accused products contain each of the limitations found in the claim.’” Boston Sci. Corp. v. Nevro
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`Corp., 415 F. Supp. 3d 482, 489 (D. Del. 2019) (quoting TMI Sols. LLC v. Bath & Body Works
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`Direct, Inc., No. 17-965-LPS-CJB, 2018 WL 4660370, at *9 (D. Del. Sept. 28, 2018)). Here, even
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`for the two limitations at issue, the Complaint references specific portions of specific materials to
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`demonstrate how Aortic alleges the SAPIEN 3 Ultra infringes; these include either photos of the
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`product or pin cites to particular pages of Edwards’s publication materials that describe the device.
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`(See ECF No. 1 ¶¶ 77–78, 82.) As a result, these direct infringement allegations are distinguishable
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`from those that have been found insufficient. See, e.g., Boston Sci., 415 F. Supp. 3d at 490
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`(dismissing a complaint for patent infringement where there was “no attempt to connect specific
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`components of the accused systems to elements of the asserted claims,” and where the complaint
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`failed to “explain how any of the 144 pages of linked materials show such a connection”); Uniloc
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`2017, 2020 WL 42601616 at *4 (dismissing a complaint where the “allegation parrots the language
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`of the claim without any factual support” and the plaintiff “did not provide examples or otherwise
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`explain how Gusto’s platform meets the elements of the asserted claim”). Because Aortic provides
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`photographic examples and page-specific citations to documents, sufficient factual allegations
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`have been made, and the Court would need to engage in fact-finding or claim construction to
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`determine if these allegations will ultimately fail. As a result, Edwards’s Motion to Dismiss as to
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`Direct Infringement of all claims except the ’538 Patent method claims is DENIED.
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`2. Direct infringement of method claims
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`Edwards asserts that “AI fails to allege that Edwards directly performs the implantation
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`method claimed in the ’538 patent.” (ECF No. 11 at PageID 1342.) Edwards also contends that
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`the Complaint does not “allege that any Edwards employee has ever directly practiced the
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`implantation method claimed in the ’538 patent.” (Id.) As a result, Edwards contends that “AI
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`fails to plausibly allege that Edwards directly infringes the ’538 patent.” (Id.)
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`In response, Aortic contends that the following sentence alleges Edwards’s direct
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`infringement of the ’538 Patent: “Edwards infringes, contributes to the infringement of, and/or
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`induces infringement of the ’538 Patent by making, using, selling, offering for sale, and/or
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`importing into the United States the Accused Products that are covered by one or more claims of
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`the ’538 Patent.” (ECF No. 13 at PageID 1372–73 (emphasis in original); ECF No. 1 ¶ 104.)
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`Aortic further contends that the Complaint “alleges that Edwards ‘tests’ the Sapien 3 Ultra, . . .
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`that the Sapien 3 Ultra is used in a manner that infringes the ’538 claim limitations, . . . and that
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`the Sapien 3 Ultra meets the structural limitations of the ’538 claims.” (ECF No. 13 at PageID
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`1373.) Aortic contends that its “use and testing allegations sufficiently plead a plausible case of
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`direct infringement by Edwards of the ’538 method claims.” (Id.) (citing DermaFocus LLC v.
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`Ulthera, Inc., 201 F. Supp. 3d 465, 468 (D. Del. 2016).)
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`On Reply, Edwards contends that the allegations in the Complaint that Aortic cites in its
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`Response are insufficient because “none of these statements allege that any Edwards employee
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`has directly implanted SAPIEN 3 Ultra in a patient.” (ECF No. 16 at PageID 1569.) Edwards
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`contends that “[b]ecause the ’538 method claims require implanting the valve assembly in a
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`patient, . . . which is performed by a ‘doctor or other medical professional,’ . . . Edwards’[s] testing
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`and demonstrations of SAPIEN 3 Ultra alleged in the Complaint cannot plausibly lead to direct
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`infringement of the ’538 patent’s method claims.” (Id.) (quoting ECF No. 1) (citing Ormco Corp.
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`v. Align Tech., Inc., 463 F.3d 1299, 1311 (Fed. Cir. 2006).)
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`At the hearing, Aortic pointed to paragraph seventeen as the section of the Complaint that
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`most clearly, in its view, alleges direct infringement of the ’538 method claims. (See Hearing Tr.
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`ECF No. 23 at PageID 1715.) In this paragraph, Aortic alleges that “Edwards employees
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`participate in surgical interventions involving TAVR devices, including the Sapien 3 Ultra,
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`including preparing the devices prior to insertion by the doctor into the patient.” (ECF No. 1 ¶
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`17.) (emphasis added.) The method claims of the ’538 Patent, however, require actual
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`implantation of the device into a patient, rather than “preparing the devices prior to insertion.” See
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`’538 Patent cols. 21–22. As a result, Aortic’s pleading fails to state a plausible claim that Edwards
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`or its employees are directly infringing those method claims. Edwards’s Motion as to the direct
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`infringement of the ’538 Patent is GRANTED.
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`IV. CONCLUSION
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`For the reasons discussed above, the Court GRANTS Edwards’s Motion as to indirect
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`infringement and willful infringement of the ’735 Patent and direct infringement of the ’538 Patent
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`and DENIES Edwards’s Motion as to direct infringement of all other patents-in-suit.
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`IT IS SO ORDERED, this 21st day of April, 2022.
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`/s/ Jon P. McCalla
`JON P. McCALLA
`UNITED STATES DISTRICT JUDGE
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`11
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