Opinion
Case No. 2:23-CV-04291-HDV
2023-08-29
BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES OF COLORADO, LLC, Plaintiff, v. VIVITRO LABS, INC., Defendant.
Kent J. Schmidt, Dorsey and Whitney LLP, Costa Mesa, CA, Maral J. Shoaei, Dorsey and Whitney, Palo Alto, CA, Shannon L. Bjorklund, Pro Hac Vice, Dorsey and Whitney LLP, Minneapolis, MN, Gregory S. Tamkin, Dorsey & Whitney LLP, Denver, CO, for Plaintiff. Jeffrey H. Grant, Fox Rothschild LLP, Los Angeles, CA, John W. Harbin, Warren J. Thomas, Pro Hac Vice, Meunier Carlin and Cufman LLC, Atlanta, GA, for Defendant.
Kent J. Schmidt, Dorsey and Whitney LLP, Costa Mesa, CA, Maral J. Shoaei, Dorsey and Whitney, Palo Alto, CA, Shannon L. Bjorklund, Pro Hac Vice, Dorsey and Whitney LLP, Minneapolis, MN, Gregory S. Tamkin, Dorsey & Whitney LLP, Denver, CO, for Plaintiff. Jeffrey H. Grant, Fox Rothschild LLP, Los Angeles, CA, John W. Harbin, Warren J. Thomas, Pro Hac Vice, Meunier Carlin and Cufman LLC, Atlanta, GA, for Defendant.
ORDER DENYING PLAINTIFF'S MOTION FOR PRELIMINARY INJUNCTION
HERNÁN D. VERA, United States District Judge
I. INTRODUCTION
Before the Court is a motion for a preliminary injunction filed by Plaintiff Biomedical Device Consultants & Laboratories of Colorado, LLC ("BDC"), seeking to enjoin Defendant Vivitro Labs, Inc. ("Vivitro") from offering its ADV Heart Valve Durability Tester device ("Motion") [Dkt. No. 60]. BDC contends Vivitro's disputed device infringes on one of its patents, U.S. Patent No. 9,237,935 ("'935 Patent") [Dkt. No. 1-1, Exh. A]. Vivitro filed a response on July 20, 2023. Opposition to Plaintiff's Motion for Preliminary Injunction ("Opp.") [Dkt. No. 80]. And on August 3, 2023, BDC filed its reply. Reply Memorandum in Support of Motion for Preliminary Injunction ("Reply") [Dkt. No. 89]. The Court held oral argument on the Motion on August 17, 2023, and took the matter under submission.
For the reasons discussed below, the Court DENIES the motion for preliminary injunction. BDC has not shown a likelihood of success on the merits because it has failed to make a "clear showing" that Vivitro likely infringed based on the claim language and evidence presented. Moreover, Vivitro has raised substantial questions regarding the patent's validity in light of prior art.
II. BACKGROUND
Both BDC and Vivitro manufacture heart valve durability testers. See Motion at 1. The patent at issue, the '935 Patent, entitled, "Fatigue Testing System for Prosthetic Devices," was issued to BDC on January 19, 2016. Complaint ("Compl.") ¶ 27 [Dkt. No. 1]. BDC incorporated this technology into its VDT-3600i, which tests the durability of prosthetic heart valves and launched "around 2010," according to its former CEO. Declaration of Craig Weinberg ("Weinberg Decl.") ¶ 11 [Dkt. No. 61]. The VDT-3600i is the company's "highest-revenue generating product," and sells for between $75,000 and $85,000 each. Weinberg Decl. ¶ 20, Motion at 14. The '935 Patent allows the VDT-3600i to rapidly test prosthetic heart equipment many times faster than a human heart, while still "closely approximating human physiology." Id. at 2. This innovation is done through an "excess volume area" that mitigates pressure spikes, thus reducing testing malfunctions. Id. Claim 1 of the '935 Patent, discloses:
A device for accelerated cyclic testing of a valved prosthetic device comprising . . . an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.'935 Patent at 17:29-50.
Vivitro is alleged to have infringed on the '935 Patent through its ADV Heart Valve Durability Tester, a competitive test system. Motion at 4. BDC first learned that Vivitro was distributing marketing materials for its new tester in the summer of 2022. Weinberg Decl. ¶ 34. While Vivitro has not delivered any of its testers, BDC alleges that Vivitro has "at least one agreement with a customer for sale" of the device. Compl. ¶ 19. No facts have been alleged in briefing or during oral arguments that any testers have been shipped yet. Plaintiff's complaint in this action was filed on April 7, 2023. A half-day hearing on the Motion was held on August 17, 2023, and the Motion was taken under submission [Dkt. No. 90].
III. LEGAL STANDARD
"A preliminary injunction is an extraordinary remedy never awarded as of right." Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 24, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008). A district court should enter a preliminary injunction only "upon a clear showing that the plaintiff is entitled to such relief." Id. at 22, 129 S.Ct. 365. When a patentee sues an alleged infringer for patent infringement and moves under 35 U.S.C. § 283 for the extraordinary relief of a preliminary injunction, the patentee's entitlement to such an injunction is a matter largely within the discretion of the district court. See Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997). A party seeking a preliminary injunction must establish that: (1) it "is likely to succeed on the merits," (2) it "is likely to suffer irreparable harm in the absence of preliminary relief," (3) "the balance of equities tips in [its] favor," and (4) "an injunction is in the public interest." Winter, 555 U.S. at 20, 129 S.Ct. 365. The Ninth Circuit has adopted an alternative sliding scale approach, in which the elements are balanced, "so that a stronger showing of one element may offset a weaker showing of another." All. of the Wild Rockies v. Cottrell, 632 F.3d 1127, 1131 (9th Cir. 2011). Specifically, "serious questions going to the merits and a hardship balance that tips sharply towards the plaintiff can support issuance of an injunction, assuming the other two elements of the Winter test are also met." Id. at 1132 (interpreting Winter and explaining that the "sliding scale" test for preliminary injunctive relief remains valid) (quotations omitted). A "serious question" is one on which the movant "has a fair chance of success on the merits." Sierra On-Line, Inc. v. Phoenix Software, Inc., 739 F.2d 1415, 1421 (9th Cir. 1984).
IV. DISCUSSION
A. Likelihood of Success on the Merits
"With regard to the first factor—establishing a likelihood of success on the merits—the patentee seeking a preliminary injunction in a patent infringement suit must show that it will likely prove infringement, and that it will likely withstand challenges, if any, to the validity of the patent." Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009); see also Trebro Mfg., Inc. v. Firefly Equipment, LLC, 748 F.3d 1159, 1166 (Fed. Cir. 2014) (a likelihood of success requires "prov[ing] that success in establishing infringement is more likely than not"). "If the accused infringer raises a substantial question concerning either infringement or validity, then the patentee has not established that it is likely to succeed on the merits, and a preliminary injunction is not appropriate." LifeScan Scotland, Ltd. v. Shasta Techs., LLC, 734 F.3d 1361, 1366 (Fed. Cir. 2013) (quotations omitted).
Additionally, when considering the Winter factors, a preliminary injunction may only be awarded "upon a clear showing" of evidence that supports each relevant preliminary injunction factor. Winter, 555 U.S. at 22, 129 S.Ct. 365. "This 'clear showing' requires factual support beyond the allegations of the complaint, but the evidence need not strictly comply with the Federal Rules of Evidence." CI Games S.A. v. Destination Films, No. 2:16-CV-05719-SVW, 2016 WL 9185391, at *11 (C.D. Cal. Oct. 25, 2016) (citing Flynt Distrib. Co., Inc. v. Harvey, 734 F.2d 1389, 1394 (9th Cir. 1984)). The "[l]ikelihood of success on the merits is the most important Winter factor"; thus, "if a movant fails to meet this threshold inquiry, the court need not consider the other factors . . . in the absence of serious questions going to the merits." Disney Enters., Inc. v. VidAngel, Inc., 869 F.3d 848, 856 (9th Cir. 2017) (quotations omitted).
Here, substantial questions have been raised concerning infringement, particularly as to whether the "excess volume area" limitation is met in the way that Plaintiff argues.
i. Infringement
"Determining literal infringement is a two-step process: the 'proper construction of the asserted claim and a determination whether the claim as properly construed reads on the accused product or method.' " ActiveVideo Networks, Inc. v. Verizon Commc'ns, Inc., 694 F.3d 1312, 1319 (Fed. Cir. 2012) (quoting Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1330 (Fed. Cir. 1999)). Literal infringement requires that "every limitation . . . in a claim must be found in an accused product, exactly." Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995).
Infringement analysis begins first with claim construction, followed by an analysis of "the allegedly infringing product to determine whether the product embodies every limitation of the claims." Biagro W. Sales, Inc. v. Grow More, Inc., 423 F.3d 1296, 1301 (Fed. Cir. 2005). "To determine likelihood of success on the patent infringement issue, the court may construe disputed claim language as a matter of law." Sofamor Danek Grp., Inc. v. DePuy-Motech, Inc., 74 F.3d 1216, 1220 (Fed. Cir. 1996). "The court then determines whether the accused device is likely to fall within the scope of the claims." Id.
"Claim terms are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history." Unwired Planet, LLC v. Apple Inc., 829 F.3d 1353, 1358 (Fed. Cir. 2016). "The appropriate starting point . . . is always with the language of the asserted claim itself." Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998). For purposes of this Motion, the Court assigns the words of the claims "their ordinary and customary meaning," meaning that "the term would have to a person of ordinary skill in the art in question at the time of the invention." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005). "Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in 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. The specification is "[u]sually . . . the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The parties both argue that plain and ordinary meaning applies to the asserted claim limitations, and the Court applies plain and ordinary meaning here. See Motion at 7; see also Opp. at 5.
BDC and Vivitro disagree about the meaning of key claim terms. If the meaning of the term is disputed, "the specification and prosecution history can provide relevant information about the scope and meaning of the claim." Electro Med. Sys., S.A. v. Cooper Life Scis., Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994) (quotations omitted).
After analyzing the key terms, patent specification, prosecution history, and the totality of evidence presented, the Court finds that substantial questions exist as to the key issue of infringement. BDC has not shown at this stage it is more likely than not that the accused product has an "excess volume area" that is "in fluid communication with the fluid return chamber . . . ." '935 Patent, 17:45-50. As shown below, Vivitro has raised substantial questions concerning whether its current configuration falls within the '935 Patent, and therefore BDC has not met its burden.
BDC alleges that Vivitro infringes all elements of claims 1-4, 8, 9 and 12-13 of the '935 Patent. Motion at 7-10. For purposes of this Motion, the Court focuses on Claim 1, the only independent claim, as all other claims depend on it. Claim 1 states in part: "an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression." '935 Patent at 17:45-50. Plaintiff's position is that Vivitro's device at issue also has "an excess volume area," which consists of "the volume adjacent to the annular compliance rings" "within the fluid return chamber." Motion at 9.
In cardiology, "compliance" is the ability of a fluid system to absorb pressure changes. See '935 Patent, 9:11-14.
The Court concludes at this stage that substantial questions exist on the issue of whether the extra space within the chamber can be the excess volume area, as contemplated and defined in the '935 Patent. More specifically, the Court finds that Plaintiff has failed to meet its burden on likelihood of success concerning infringement at this stage for at least four reasons.
First, the specification outlined in the '935 Patent teaches that to make the system shown in Figs. 1-5B of the '935 Patent, the system needs a "compliance chamber" to hold the excess volume. This suggests that it would be at least a separate space, if not a separate structure altogether. The specification states in relevant part:
"The compliance chambers provide excess volume area for fluid to move into when the piston performs a compression stroke. As the pressure of the gas in the compliance chamber increases, the volume occupied by the gas decreases to provide additional volume for displacement of the liquid working fluidly within the test chamber."'935 Patent at 12:4-9 (emphasis added).
As Vivitro's system is all connected, it would be inconsistent with the specification. See Phillips, 415 F.3d at 1313 ("the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification."). There also exists a separate question as to Claim 9 of whether the area inside the "compliance rings" in Defendant's device can fairly be characterized as a "compliance chamber." The plain and ordinary meaning of "chamber" suggests that it should be its own separate area. The claim requirement that the "excess volume area" is "in fluid communication with the fluid return chamber" also implies a separate structure. If it consisted of simply more space in the chamber, the patent would not need to include the phrase "in fluid communication with." The claim language suggests that the excess fluid is going somewhere, and the specification implies it is the chamber where the fluid is moving into.
Second, Plaintiff's interpretation is at odds with the position that it took in prior proceedings before the PTO. In BDC's preliminary response to an Inter Partes Review (IPR) in 2018 for a related patent, BDC argued that in a competitor design:
"flexible bags/containers act as compliance, however, unlike compliance chamber 135 of [BDC's patent], the total volume of the channel remains constant. That is, any pressure being mitigated would presumably be through material deformation—not by providing a space in addition to the channel to store some of the excess introduced fluid. Therefore, [the competing design] has no 'excess volume area' for storing fluid in excess of that contained in the channel."Waters Technologies Corp. v. Biomedical Device Consultants & Laboratories, IPR2018-00498, Patent Owners' Preliminary Response ("Opp., Ex. 7") at 37 (emphasis added) [Dkt. No. 80-7]. Stated differently, BDC takes the position that material deformation that provides compliance is not a space for fluid to flow into. Later, BDC adds that "the pressure to the extent mitigated presumably is through the deformation of a material—not by providing a space in addition to the channel for storing excess fluid. Thus, [the competing design] has no 'excess volume area' for storing fluid in excess to that contained in the channel, as required by claim 1." Opp., Ex. 7 at 47 (emphasis added). BDC's position is inconsistent with its prior interpretations. "[T]he same claim term in . . . related patents carries the same construed meaning." Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1334 (Fed. Cir. 2003). During the claim construction phase, the parties will have an opportunity to brief the issue in more depth, but at this phase, BDC's prior position raises substantial infringement questions. Vivitro's disputed device works like the competing design from the IPR proceeding, as its closed "compliance rings" absorb pressure by material deformation. Reply at 5.
Third, Vivitro's disputed device does not include an "excess volume area" "in fluid communication with the return chamber," which is at odds with the claim language. '935 Patent at 17:45-50. BDC argues that in Vivitro's disputed device, the excess volume area is "the area within the tubes that is occupied by gas when the system is not under compression and is occupied by the excess volume of test fluid when the system is under compression." Motion at 10. But examining Vivitro's designs, "the area within the tubes" is a closed chamber. See Opp., Ex. 8 [Dkt. No. 88-8]. No "fluid communication" exists between the tubes and any other part of the device. The "fluid communication" requirement of Claim 1 is not met. BDC further alleges that the excess volume area is "the volume adjacent to the annular compliance rings" when those rings are allegedly compressed. Motion at 9. To demonstrate, BDC includes the following illustrations below. Id.
Image materials not available for display.
Not in compression
Image materials not available for display.
Under compression
BDC suggests that the "excess volume area" can be a temporarily available area, which is not supported by the language of Claim 1 or the specification. In these illustrations, the excess volume area of Vivitro's device only exists when under compression but becomes non-existent when not in compression. Nothing in the patent suggests that the extra volume area can exist only temporarily . BDC's prior position in the IPR proceeding supports this view, as "material deformation" does not meet the excess volume area limitation. Opp., Ex. 7, at 37, 47. Vivitro's design uses the material deformation of these closed rings, not the fluid flow into an excess volume area, to provide compliance. The "volume adjacent to the annular compliance rings" is not an excess volume area and thus raises substantial questions as to infringement of the '935 Patent. Motion at 9. Since Plaintiff has not shown that Claim 1 has more likely than not been infringed, the asserted dependent claims 2, 3, 4, 8, 9, 12, and 13 are also not likely to have been infringed. Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989) ("One who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim").
And fourth, Claim 9 (a dependent claim of Claim 1) raises substantial questions about BDC's theory as to what "excess volume area" means under the doctrine of claim differentiation. This doctrine applies a presumption of difference in meaning and scope when different words or phrases are used in separate claims. See Comark Commc'ns, Inc., 156 F.3d at 1187 (invoking doctrine to support claim construction; although "the doctrine of claim differentiation is not a hard and fast rule of construction, it does create a presumption that each claim in a patent has a different scope"). Here, this doctrine is appropriate to apply given that Claim 9 contemplates new features that alternative interpretation would render moot. Claim 9 states in relevant part: "The device of claim 1, where in the excess volume area comprises a compliance chamber defining a cavity within the fluid return chamber." '935 Patent at 18:29-32 (emphasis added). If BDC's interpretation of "excess volume area" in Claim 1 always contemplated "within the fluid return chamber," then Claim 9 would not add anything. See Motion at 9.
"To show literal infringement of a patent, a patentee must supply sufficient evidence to prove that the accused product or process meets every element or limitation of a claim." Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997). While BDC may be able to prove this in further proceedings, substantial questions have been raised at this point to justify a denial of Plaintiff's motion for preliminary injunction. The plain and ordinary meaning of "excess volume area," as used in Claim 1 and as supported by the teachings of the specification, is a compliance chamber that is separate and needs to be fluidly connected. Plaintiffs may prevail during claim construction proceedings in the future, where the Court can more closely examine briefing around the prosecution history of the patent, the Inter Partes Review (IPR) proceedings, and extrinsic evidence to discern the patent's meaning. But based on the existing record, the Court finds that substantial questions have been raised as to whether Plaintiff's patent was infringed by Defendant.
ii. Validity
"Vulnerability is the issue at the preliminary injunction stage," not whether the patent is invalid by the clear and convincing evidence standard that will be used at trial. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1359 (Fed. Cir. 2001). If there are "substantial questions as to the validity" of the asserted patents, then "the necessary prerequisites for entry of a preliminary injunction" have not been satisfied even if the patentee has established a likelihood of success on the issue of infringement. Amazon.com, Inc., 239 F.3d at 1366. The Court "does not resolve the validity question" at this stage, but instead "assess[es] . . . the persuasiveness of the challenger's evidence," recognizing that it is a preliminary stage. Titan Tire Corp., 566 F.3d at 1377 (quotations omitted). "Instead of the alleged infringer having to persuade the trial court that the patent is invalid, at this stage it is the patentee, the movant, who must persuade the court that, despite the challenge presented to validity, the patentee nevertheless is likely to succeed at trial on the validity issue." Id. Here, Vivitro has presented evidence of invalidity, and BDC has not demonstrated at this point that Vivitro's assertions lack substantial merit.
Patents can be invalid over the prior art by being either anticipated or obvious. A claim is anticipated where "each and every [limitation] is found within a single prior art reference." Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1331 (Fed. Cir. 2020). A patent is obvious if "the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art . . . ." 35 U.S.C. § 103.
Examining the prior art, the Court finds a substantial question concerning whether the prior art included "excess volume areas" to absorb pressure changes in accelerated test systems, raising substantial concerns that the '935 Patent is invalid. First, the Dynatek M6 user manual published in 1993 appears to include an annotated figure with an "excess volume area" that is described as a "capacitance tank." Opp., Exh. 5, Fig. 1A ("Dynatek") [Dkt. No. 80-5].
Image materials not available for display.
Dr. Dasi's declaration supports the view that Dynatek discloses every element of Claim 1 and thus anticipates Claim 1 and other dependent claims. Dasi Declaration ("Dasi Decl.") ¶ 59.
Vivitro also points to another patent, the Xi patent from 1997, that includes an "air chamber" placed downstream of the device being tested, where "liquid flows from the test chamber into the air chamber" during operation." Opp., Ex. 3 at 5 ("Xi patent") [Dkt. No. 80-3]. Together with Dynatek, Vivitro asserts that "the '935 Patent claims are all obvious variations on Dynatek and Xi, and so all the asserted claims are invalid as obvious." Opp. at 12; see also Dasi Decl. ¶ 45.
BDC argues that Xi and Dynatek do not anticipate the '935 Patent, arguing that Xi's "piston" and Dynatek's "see-saw" are "completely different" from the '935 Patent, even presenting video reproductions at oral arguments to demonstrate how the different devices deal with fluid and pressure. But the '935 Patent does not specify the "pressure source" that moves the fluid, so substantial doubt remains as to validity based on the plain language of the patent. '935 Patent at 17:31. Similar doubts remain for the concept of obviousness, and the Court will benefit from future briefing to determine whether the teachings of Xi, Dynatek, and Lu could have been combined. V. CONCLUSION
In summary, BDC has failed to show a likelihood of success on the merits in terms of infringement, and Vivitro has raised additional (and substantial) questions regarding the validity of Plaintiff's underlying patent. For all of these reasons, Plaintiff's motion is denied.
The parties have presented extensive evidence and briefing on the questions of irreparable harm and the balance of equities. After reviewing, the Court finds that "hardship balance" does not "tip[ ] sharply toward the plaintiff" and thus does not support the issuance of an injunction, even under the Ninth Circuit's sliding scale approach. All. for the Wild Rockies, 632 F.3d at 1132. Because the Court has concluded that Plaintiff failed to meet its burden to show a likelihood of success on the issues of infringement and validity, the Court need not discuss the merits of these latter arguments, as they would not change the outcome.
IT IS SO ORDERED.