Inari Medical, Inc. v. Imperative Care, Inc.

1

2

3

4 UNITED STATES DISTRICT COURT

5 NORTHERN DISTRICT OF CALIFORNIA

6

7 INARI MEDICAL, INC., Case No. 24-cv-03117-EKL

8 Plaintiff,

ORDER DENYING MOTION FOR

9 v. PRELIMINARY INJUNCTION

10 IMPERATIVE CARE, INC., et al., Re: Dkt. No. 83

Defendants.

11

12

13 This patent infringement action relates to medical devices used to treat blot clots in

14 patients. Plaintiff Inari Medical, Inc. (“Inari”) seeks a preliminary injunction that would require

15 its competitor, Defendant Imperative Care, Inc. (“Imperative Care”), to stop making, using, and

16 selling its devices in the United States. The Court reviewed the parties’ briefs, the relevant

17 authority, and the complete record, and heard argument on Inari’s motion. The Court also

18 requested and reviewed supplemental briefing on developments in the parallel inter partes review

19 proceedings before the Patent Trial and Appeal Board (“PTAB”). For the following reasons,

20 Inari’s motion is DENIED.

21 I. BACKGROUND

22 The two patents asserted in Inari’s motion relate to mechanical thrombectomy systems,

23 i.e., devices used to remove blood clots from veins. This section discusses the medical need for

24 thrombectomy systems and then describes Inari’s and Imperative Care’s competing devices.

25 A. The Relevant Field

26 Inari and Imperative Care sell competing medical devices that treat venous

27 thromboembolism (“VTE”) – that is, blood clots that form in a patient’s veins. “VTE is a

1 United States and millions worldwide.” Merritt Decl. ¶ 6, ECF No. 23-4. When a blood clot

2 forms in a vein, it can block blood flow, which in turn may cause serious health conditions,

3 including strokes and heart attacks. Brown Decl. ¶ 32, ECF No. 23-5.

4 There are two types of VTE: deep vein thrombosis (“DVT”) and pulmonary embolism

5 (“PE”). A DVT clot forms in a patient’s peripheral vasculature, usually in deep leg veins. Merritt

6 Decl. ¶¶ 14, 27. The clot forms on a vessel wall and slowly grows inward to create a blockage.

7 Id. ¶ 13. By contrast, a PE clot is “free floating” – not attached to a vessel wall – and is found in a

8 patient’s lungs. Id. Most commonly, “clots in PE patients are simply deep leg vein clots that have

9 mobilized (meaning they have broken off and traveled to the lungs).” Id. ¶ 27.

10 Traditionally, DVT and PE have been treated with drugs such as anticoagulants (i.e., blood

11 thinners), which help prevent clot formation, and thrombolytics, which “break down and dissolve

12 the clot over hours or days, but do not physically remove the clot material from the body.” Brown

13 Decl. ¶ 39. However, these drugs have limitations and disadvantages. Anticoagulants “are not

14 effective against existing clots,” and they have potential side effects, including “bleeding risk and

15 loss of bone density.” Id. ¶ 41. Thrombolytics “can take many hours to work,” and “because the

16 clots are not actually removed from the body, portions of the clot can break off and travel to a

17 different location within the body rather than being eliminated entirely.” Id. ¶ 40.

18 Although these traditional treatments still dominate, in recent years, thrombectomy

19 procedures have also been used to treat DVT and PE. Id. ¶ 42. Thrombectomy refers to “physical

20 removal of clotted blood . . . from the vasculature.” Id. Here, the relevant devices are catheter-

21 based thrombectomy systems. Id. ¶ 44. To use one of these devices, a doctor inserts a catheter

22 into the patient’s vasculature (i.e., blood vessels) and advances the catheter until it reaches the

23 blood clot. Id. ¶ 48. A doctor may use a combination of methods and tools to remove the clot,

24 including scraping (often used for DVT clots, which are attached to vessel walls) and aspiration

25 (i.e., suction). Aspiration-based devices remove a clot by generating vacuum pressure using a

26 pressure source to suck the clot into the catheter tip and out of the patient’s vasculature. Id.

27 Although “companies have long produced catheter thrombectomy systems for treating clots in

1 B. Inari’s Devices

2 Inari was founded in 2011 and focuses on “developing pioneering treatments for the

3 || removal of blood clots from veins.” Hykes Decl. § 4, ECF No. 23-6. Although Inari asserts many

4 || more patents in this case, for purposes of the present motion, Inari asserts that Imperative Care

5 || infringes U.S. Patent Nos. 11,844,921 (921 Patent) and 11,974,910 (910 Patent). The patents

6 || issued on December 19, 2023, and May 7, 2024, respectively. The relevant patent claims are

7 discussed below. See infra Section III.A.

8 Over the years, Inari has experimented with and refined its devices based on feedback from

9 || doctors. Merritt Decl. {| 42; Brown Decl. The Court focuses on Inari’s fourth generation

10 || FlowTriever device because it incorporates the technology covered by the two patents asserted

11 here. The FlowTriever device is a type of catheter-based thrombectomy system as described

12 above. The following image shows the catheter of a FlowTriever device positioned next to a

13 blood clot. The image also shows the syringe, which generates a stored vacuum. By moving the

14 || stopcock to the “open” position, the user can release the stored vacuum, which rapidly applies

15 suction and, if successful, sucks the clot through the catheter and into the syringe. Inari refers to

16 || this deployment of suction as “WHOOSH.” Merritt Decl. § 34.

3 17 Image 1: Inari’s FlowTriver Device with Vacuum-Generating Syringe!

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28 ' Brown Decl. [§] 236-237.

1 Inari explains that DVT and PE clots pose special challenges given the large size of the

2 vessels and the location of the clot deep in a patient’s vasculature. See id. ¶ 28. Inari claims that it

3 developed three key innovations to address these challenges, which are relevant to its infringement

4 claims against Imperative Care. First, Inari developed a system for “telescoping” catheters in

5 which a smaller catheter can be advanced through a larger catheter to reach further into a patient’s

6 vasculature and to provide a second aspiration attempt. Brown Decl. ¶ 72. Second, Inari

7 discovered that the use of 16F and 24F diameter catheters are ideal – with the 16F catheter

8 telescoped through the larger 24F catheter.2 Third, Inari developed an improved hemostasis valve.

9 Among other things, a hemostasis valve prevents backflow of blood through the lumen (i.e., the

10 hollow space) of a catheter. Id. ¶¶ 56-57. Inari’s hemostasis valve uses one or more filaments to

11 circumferentially constrict the lumen, in a choking motion. Merritt Decl. ¶ 52 (describing how the

12 valve forms a “garrote”).

13 C. Imperative Care’s Symphony Device

14 Imperative Care was founded in 2015 by a neurosurgeon who pioneered minimally

15 invasive treatments for stroke patients. Nalbone Decl. ¶ 5, ECF No. 79. Imperative Care began

16 developing its mechanical thrombectomy systems in late 2019 and early 2020 by investing in

17 Truvic, which it acquired in 2021. Id. ¶ 8 (explaining that Truvic has now merged into Imperative

18 Care). Imperative Care’s thrombectomy system is called Symphony, and it includes multiple

19 components, including different catheter sizes, tools, and a generator to create vacuum for suction.

20 Scott Decl. ¶ 8, ECF No. 35-3. “Depending on the procedure and the physician’s preferences, the

21 physician may use some or all of these components to treat the patient.” Id. The following image

22 shows a Symphony catheter placed next to a blood clot.

23

24

25

26

27

1 Image 2: Symphony Catheter Removing Blood Clot?

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18 Like Inari’s devices, Symphony uses aspiration to physically remove blood clots from a

19 patient’s vasculature. Unlike Inari’s system, which uses a syringe that is pulled back to manually

generate a stored vacuum, Symphony uses a generator to create a high-powered, on-demand,

continuous vacuum. Scott Decl. 4 12. However, the fundamental concept is the same: The

Symphony system uses suction to remove the blood clot from the patient’s vasculature through a

74 catheter. The clot material travels through the catheter to a “clot container” located in the handle

of the Symphony device. The clot container is transparent and includes a filter that separates the

aspirated blood from clot material. Jd. {| 13. This container enables the physician to rapidly assess

06 case progress. Id. The following images show these aspects of the Symphony system. Imperative

97 Care sells 16F and 24F catheters, which can be telescoped as shown in Image 4.

28 3 Brown Decl. §] 154.

1 Image 3: Diagram of the Symphony Device Handle with Vacuum Generator*

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22 In February 2023, Imperative Care obtained clearance from the U.S. Food and Drug

23 || Administration (“FDA”) to sell Symphony for use in treating DVT. Nalbone Decl. In

94 || August 2023, Imperative Care began selling Symphony and has sold Symphony continuously

25 since that time. /d. At the time, neither of the patents asserted in this motion had issued. In

26 || October 2023, Imperative Care initiated a clinical trial to assess the safety and efficacy of the

27 || —_

* Brown Decl. {] 136.

sia. q 156.

1 Symphony system in treating PE. Id. On August 28, 2025, Imperative Care received FDA

2 clearance to market Symphony for treating PE. See Notice of FDA Clearance at 1, ECF No. 134.

3 Imperative Care “expects to commence a limited market release in the coming months.” Id.

4 D. Inari’s Request for Relief

5 Inari asks the Court to order that:

6 Defendant Imperative Care, Inc. and its officers, agents, servants, employees, and

attorneys, and any other person acting in active concert or participation with of the

7 above, are preliminarily enjoined from making, using, selling, offering to sell,

importing, marketing, or distributing its Symphony system in the United States,

8

except to the extent that those activities relate to clinical study activity exempted from

9 infringement liability by 35 U.S.C. § 271(e)(1).

10 Proposed Order, ECF No. 24-7. The practical effect of this order, if entered, would be to prevent

11 all sales and marketing of Symphony for either DVT or PE.

12 II. LEGAL STANDARD

13 A. The Winter Elements

14 A plaintiff seeking a preliminary injunction must establish that “he is likely to succeed on

15 the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the

16 balance of equities tips in his favor, and that an injunction is in the public interest.” Winter v. Nat.

17 Res. Def. Council, Inc., 555 U.S. 7, 20 (2008); see also Apple Inc. v. Samsung Elecs. Co., 695 F.3d

18 1370, 1373-74 (Fed. Cir. 2012) (“Apple II”). “[A] trial court need not make findings concerning

19 the third and fourth factors if the moving party fails to establish either of the first two factors.”

20 Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 973-74 (Fed. Cir. 1996) (citation omitted); see

21 also Bennett v. Isagenix Int’l LLC, 118 F.4th 1120, 1126 (9th Cir. 2024) (similar).

22 “A preliminary injunction is an extraordinary remedy never awarded as of right. In each

23 case, courts ‘must balance the competing claims of injury and must consider the effect on each

24 party of the granting or withholding of the requested relief.’” Winter, 555 U.S. at 24 (citations

25 omitted). The Court must also consider the scope and nature of the requested relief because “[t]he

26 purpose of a preliminary injunction is merely to preserve the relative positions of the parties until

27 a trial on the merits can be held.” Lackey v. Stinnie, 604 U.S. 192, 200 (2025) (quoting Univ. of

1 B. Application to Patent Infringement Cases

2 The parties dispute whether Inari seeks a mandatory or prohibitory injunction. “A

3 mandatory injunction ‘orders a responsible party to take action’” and “goes well beyond simply

4 maintaining the status quo” while the litigation is pending. Marlyn Nutraceuticals, Inc. v. Mucos

5 Pharma GmbH Co., 571 F.3d 873, 878-79 (9th Cir. 2009) (citations omitted). “The inquiry is

6 whether the party seeking the injunction seeks to alter or maintain the status quo.” Fellowship of

7 Christian Athletes v. San Jose Unified Sch. Dist. Bd. of Educ., 82 F.4th 664, 684 (9th Cir. 2023).

8 In the Ninth Circuit, mandatory injunctions are “particularly disfavored,” and the movant faces a

9 higher burden to show that “the facts and law clearly favor the moving party.” Id. (first quoting

10 Marlyn Nutraceuticals, 571 F.3d at 879; and then quoting Stanley v. Univ. of S. Cal., 13 F.3d

11 1313, 1320 (9th Cir. 1994)).

12 Here, the pre-dispute status quo is one in which Imperative Care was selling its Symphony

13 system – at least for DVT procedures – before Inari’s two asserted patents issued. The patents had

14 not issued in the pre-dispute status quo, thus Inari did not have a legal right to exclude Symphony

15 from the market. See Welker Bearing Co. v. PHD, Inc., 550 F.2d 1090, 1095 (Fed. Cir. 2008).

16 Because Inari seeks to change the pre-dispute status quo by excluding Symphony from the market,

17 Inari seeks a mandatory injunction. Inari resists this conclusion, arguing that Imperative Care’s

18 “sales are just beginning and it has not yet even been cleared to market its accused Symphony

19 system for PE.”6 Mot. at 3, ECF No. 83. But whether Imperative Care’s sales are small or large,

20 the critical fact is that Symphony was being sold in the pre-dispute status quo, and Inari’s

21 proposed injunction would require Imperative Care to cease all sales and marketing activities.

22 This relief is mandatory in nature.

23 Inari questions whether the Ninth Circuit’s heightened standard for mandatory injunctions

24 applies in patent infringement cases. Reply at 5, ECF No. 84 (arguing that “the concept of

25

6 Symphony was not being sold for PE in the pre-dispute status quo because it had not yet

26

obtained FDA clearance for such procedures. However, the same Symphony device can be used

to treat both DVT and PE, so there is no question that barring all sales of Symphony would change

27

the status quo. Inari has not identified any practical and enforceable way to tailor a potential

1 ‘mandatory injunctions’ is almost never mentioned in the dozens of preliminary injunction

2 decisions in this District in patent cases”).7 Generally, the Federal Circuit “review[s] a grant or

3 denial of a preliminary injunction using the law of the regional circuit” where the case originated –

4 here, the Ninth Circuit. Murata Mach. USA v. Daifuku Co., 830 F.3d 1357, 1363 (Fed. Cir. 2016)

5 (citing Trebro Mfg., Inc. v. Firefly Equip., LLC, 748 F.3d 1159, 1165 (Fed. Cir. 2014)); see also

6 Mikohn Gaming Corp. v. Acres Gaming, Inc., 165 F.3d 891, 894 (Fed. Cir. 1998) (observing that

7 the Federal Circuit “benefit[s] from the wealth of Ninth Circuit precedent” applying the

8 preliminary injunction standard). “However, the Federal Circuit has itself built a body of

9 precedent applying the general preliminary injunction considerations to a large number of

10 factually variant patent cases, and gives dominant effect to Federal Circuit precedent insofar as it

11 reflects considerations specific to patent issues.” Natera, Inc. v. NeoGenomics Labs., Inc., 106

12 F.4th 1369, 1375 (Fed. Cir. 2024) (quoting Murata, 830 F.3d at 1363).

13 In Revision Military, Inc. v. Balboa Manufacturing, Co., the Federal Circuit limited the

14 extent to which district courts may apply a heightened standard for issuing a preliminary

15 injunction. 700 F.3d 524, 526 (Fed. Cir. 2012). In that case, the accused product was already on

16 the market, thus the requested preliminary injunction would “alter the [defendant’s] status.” Id. at

17 525. Therefore, the district court applied the Second Circuit’s requirement of a “clear and

18 substantial likelihood of success” on the merits. The Federal Circuit reversed, holding that a

19 heightened requirement was inconsistent with the Federal Circuit’s own standard, which asks

20 “whether success is more likely than not.” Id. at 525-26. The Federal Circuit reasoned that,

21 because “matters of patent infringement are unique to patent law, . . . the estimated likelihood of

22 success in establishing infringement is governed by Federal Circuit law.” Id. at 526. However,

23 the Federal Circuit recognized that “the weight of the likelihood [of success] may be considered as

24 an equitable factor, along with issues of the position of the parties with respect to the status quo, in

25 the ultimate balance of equities.” Id. at 526.

26

7 But see UTTO Inc. v. Metrotech Corp., No. 22-cv-01904-WHO, 2022 WL 1814145, at *2 (N.D.

27

Cal. June 2, 2022) (holding that injunction was mandatory because it would require the defendant

1 In light of the Federal Circuit’s instruction, the Court will not require Inari to make a

2 heightened showing of its likelihood of success on its infringement claim because doing so would

3 be inconsistent with the standard applied by the Federal Circuit.8 Id. at 525-26. However,

4 consistent with Revision Military, the Court will consider the mandatory nature of Inari’s

5 requested injunction when balancing the equities and considering the nature of the potential harm

6 to Inari. Marlyn Nutraceuticals, 571 F.3d at 879 (holding that a mandatory injunction should not

7 issue “unless extreme or very serious damage will result”).9

8 III. DISCUSSION

9 Imperative Care opposes Inari’s motion, arguing that Inari has failed to satisfy any of the

10 Winter elements. The Court agrees. First, Imperative Care has raised a substantial question as to

11 the validity of Inari’s asserted patent claims, and therefore Inari has not shown a likelihood of

12 success on the merits. Second, Inari has not shown that it faces a likelihood of irreparable harm in

13 the absence of a preliminary injunction, nor that there is a causal nexus between the alleged

14 infringement and the harm that Inari may face. Third, the balance of the hardships tips in

15 Imperative Care’s favor because Inari is unlikely to suffer irreparable harm while the case is

16 pending, but halting all sales and marketing of Symphony would impose severe hardship on

17

18 8 In the Court’s view, requiring a patent holder to show that the facts and the law clearly favor a

mandatory injunction does not relate to a matter of patent law, and thus Ninth Circuit precedent

19 should apply. The heightened standard for issuing a mandatory injunction does not alter the

substantive legal standard for a patent infringement claim. Rather, it allows a court to weigh the

20 strength of the movant’s case in light of the substantive law and the evidence produced. See

Garcia v. Google, Inc., 786 F.3d 733, 740 (9th Cir. 2015) (“Because [plaintiff] seeks a mandatory

21 injunction, she must establish that the law and facts clearly favor her position, not simply that she

is likely to succeed.”). This is an appropriate equitable consideration that seems equally

22 applicable to patent infringement cases. Cf. eBay Inc. v. MercExhange, L.L.C., 547 U.S. 388, 391

(2006) (holding that the “well-established principles of equity” apply “with equal force to disputes

23 arising under the Patent Act”).

9 The Ninth Circuit also applies a “sliding scale” approach under which “‘serious questions going

24

to the merits’ and a balance of hardships that tips sharply towards the plaintiff can support

issuance of a preliminary injunction, so long as the plaintiff also shows that there is a likelihood of

25

irreparable injury and that the injunction is in the public interest.” All. for the Wild Rockies v.

Cottrell, 632 F.3d 1127, 1135 (9th Cir. 2011). The “serious questions” standard does not apply for

26

two reasons. First, Inari seeks a mandatory injunction. See Doe v. Snyder, 28 F.4th 103, 111 n.4

(9th Cir. 2022). Second, the balance of hardships does not tip sharply in Inari’s favor for the

27

reasons discussed below. See infra Section III.C. Additionally, to the extent the “sliding scale”

1 Imperative Care. Finally, although the public interest generally favors enforcing patent rights,

2 here, this element is neutral given the questionable validity of Inari’s patent claims. Therefore,

3 Inari has not shown that it is entitled to the extraordinary relief of a preliminary injunction –

4 regardless of whether it seeks prohibitory or mandatory relief.

5 A. Likelihood of Success on the Merits

6 “[W]hether performed at the preliminary injunction stage or at some later stage in the

7 course of a particular case, infringement and validity analyses must be performed on a claim-by-

8 claim basis.” Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir.

9 2001). “Therefore, in cases involving multiple patent claims, to demonstrate a likelihood of

10 success on the merits, the patentee must demonstrate that it will likely prove infringement of one

11 or more claims of the patents-in-suit, and that at least one of those same allegedly infringed claims

12 will also likely withstand the validity challenges presented by the accused infringer.” Id. “In

13 assessing whether the patentee is entitled to the injunction, the court views the matter in light of

14 the burdens and presumptions that will inhere at trial.” Titan Tire Corp. v. Case New Holland,

15 Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009).

16 Here, the Court focuses on Imperative Care’s invalidity challenges to Inari’s asserted

17 patents.10 A “patent enjoys the same presumption of validity during preliminary injunction

18 proceedings as at other stages of litigation.” Id. at 1377. Therefore, at this stage, “the burden is on

19 [the alleged infringer] to come forward with evidence of invalidity.” Id. The patent holder “has

20 the burden of responding with contrary evidence,” and “must persuade the court that, . . . [it]

21 nevertheless is likely to succeed at trial on the validity issue.” Id. “[I]f the trial court concludes

22 there is a ‘substantial question’ concerning the validity of the patent, meaning that the alleged

23 infringer has presented an invalidity defense that the patentee has not shown lacks substantial

24 merit, it necessarily follows that the patentee has not succeeded in showing it is likely to succeed

25 at trial on the merits of the validity issue.” Id. at 1378-79. “The relevant inquiry is therefore

26

27

10 Imperative Care asserts that both patents are invalid, but argues non-infringement only with

1 whether the patentee has shown it is more likely than not to prevail over an invalidity challenge.”

2 Natera, 106 F.4th at 1377.

3 Two types of validity challenges are at issue here: anticipation and obviousness. Subject

4 matter is “‘anticipated’ when it is not new; that is, when it was previously known. Invalidation on

5 this ground requires that every element and limitation of the claim was previously described in a

6 single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in

7 possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir.

8 2008). “The way in which the elements are arranged or combined in the claim must itself be

9 disclosed, either expressly or inherently, in an anticipatory reference.” Therasense, Inc. v. Becton,

10 Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010).

11 By contrast, a patent claim is invalid for obviousness “if the differences between the

12 claimed invention and the prior art are such that the claimed invention as a whole would have been

13 obvious before the effective filing date of the claimed invention to a person having ordinary skill

14 in the art to which the claimed invention pertains.” 35 U.S.C. § 103. However, the existence of

15 disparate pieces of prior art is not enough – the person of ordinary skill in the art must have some

16 “motivation to combine prior art references to arrive at the claimed invention. Natera, 106 F.4th

17 at 1376. The party challenging the patent’s validity “must show a reason why a skilled artisan

18 would have made the combination.” Id.; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,

19 417-18 (2007).

20 “Obviousness is a question of law with several underlying factual inquiries: (1) the scope

21 and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the

22 level of ordinary skill in the field of the invention; and (4) objective considerations such as

23 commercial success, long felt but unsolved need, and the failure of others.” Transocean Offshore

24 Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1347 (Fed. Cir. 2012). The

25 prima facie inquiry focuses on the first three elements. Id. at 1348-49. “A party is also free to

26 introduce evidence relevant to . . . objective evidence of nonobviousness, which may be sufficient

27 to disprove or rebut a prima facie case of obviousness.” Id. at 1349. A court must consider

1 Where a movant relies on commercial success of an invention to argue that it was not obvious, the

2 movant must show “both commercial success and that a nexus exists between that success and the

3 merits of the claimed invention.” Id. at 1350; see also Fox Factory, Inc. v. SRAM, LLC, 944 F.3d

4 1366, 1373 (Fed. Cir. 2019).

5 1. The ’921 Patent

6 Inari asserts independent claim 1 and dependent claim 10 of the ’921 Patent, which claims

7 a hemostasis valve. As discussed above, hemostasis valves are used to create a seal that

8 minimizes patient blood loss and maintains a sterile environment in a patient’s blood vessels. See

9 Mot. at 12. Inari contends that the claimed valve was developed to solve known issues with prior

10 art valves. “Specifically, those prior art valves did not adequately seal around a variety of

11 catheters – which increases the odds that patients will experience dangerous blood loss – or

12 provide for ease of use (e.g., one-handed operation, easily controlled force) during complicated

13 procedures.” Mot. at 13. Inari claims that Imperative Care’s Symphony system infringes because

14 it uses a “garrote hemostasis valve with an active tensioning mechanism biased to a constricted

15 position, in which a central tubular piece is constricted by filament lines, just like the unique

16 hemostasis valve design of both FlowTriever and ClotTriever.” Mot. at 14.

17 Asserted claims 1 and 10 are recited below:

18 1. A valve, comprising:

19 an elongate member defining a lumen;

20 an active tensioning mechanism including an actuator coupled to the elongate

member via a filament extending at least partially around the elongate member,

21

wherein the actuator is moveable between (a) a first position wherein the lumen

22 is constricted and sealed and (b) a second position wherein the lumen is at least

partially open; and

23

a biasing member configured to bias the actuator to the first position.

24

[. . . .]

25

10. The valve of claim 1 wherein the actuator is a first actuator, wherein the filament

26

is a first filament, wherein the biasing member is a first biasing member, and wherein

27 the active tensioning mechanism further comprises:

1 extending at least partially around the elongate member, wherein the second

actuator is moveable between (a) a first position wherein the lumen is constricted

2 and sealed and (b) a second position wherein the lumen is at least partially open;

and

3

a second biasing member configured to bias the second actuator to the first

4 position.

5 °921 Patent at 22:12-22, 22:53-64.

6 Imperative Care argues that these claims are invalid because they are anticipated by, and

7 || obvious in light of, the prior art. Imperative Care argues that one prior art reference (“Schaffer”)

8 || anticipates the °921 Patent claims, and the combination of Schaffer with other prior art references

9 || (especially “Hartley”), renders the claims obvious. Image 5 illustrates Imperative Care’s argument

10 || that the Schaffer prior art reference has the same components, in the same arrangement, as the

11 valve claimed by the °921 Patent. Image 6 illustrates Imperative Care’s argument that combining

= 12 || Schaffer with the string-based constricting filament in Hartley renders the ’921 Patent claims

.

13 obvious.

14 Image 5: ’921 Patent Compared to Schaffer (annotated)!!

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28 || '! Opp. at 3, 21, ECF No. 78.

1 Image 6: Proposed Combination of Schaffer and Hartley!”

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2 415 Imperative Care raised these same arguments in an inter partes review (“IPR”) petition to

A 16 || the PTAB with respect to another Inari patent in the same family as the ’921 Patent, and the PTAB

3 17 || instituted review. ’011 Patent IPR Order. In instituting IPR, the PTAB concluded that Imperative

18 || Care has shown “a reasonable likelihood that it will prevail” in showing that at least one of the

19 challenged patent claims is invalid. Jd. at 2; see also 35 U.S.C. § 314(a). District courts may —

209 || and often do — consider the PTAB’s rulings when determining a patent holder’s likelihood of

71 success on the merits. See Procter & Gamble Co. v. Kraft Foods Glob. Inc., 549 F.3d 842, 847-48

22 (Fed. Cir. 2008); see also Kimberly-Clark Worldwide, Inc. v. First Quality Baby Prods., LLC, 431

23 || F. App’x 885, 889 n.3 (Fed. Cir. 2011). Many courts have found that the institution of IPR, by

24 || itself, raises a substantial question of a patent’s invalidity. Alexion Pharms., Inc. v. Samsung

5 Bioepis Co., No. 24-5-GBW, 2024 WL 2111988, at *2 (D. Del. May 6, 2024); Adidas Am., Inc. v.

6 Skechers USA, Inc., No. 3:16-cv-1400-SI, 2017 WL 2604310, at *6 (D. Or. June 12, 2017)

||}.

Decision Granting Institution of IPR of □□□ Patent at 34, ECF No. 101-5 (“011 Patent IPR

28 || Order”).

1 (collecting cases). At minimum, the PTAB’s ruling serves as strong circumstantial evidence that

2 Imperative Care has raised a substantial question of validity.

3 The PTAB’s institution decision is directly on point here. The PTAB preliminarily agreed

4 with Imperative Care as to both the anticipation (Schaffer) and obviousness (Schaffer plus

5 Hartley) arguments summarized above. ’011 Patent IPR Order at 32-41. The PTAB concluded

6 that Imperative Care established a “reasonable likelihood that it will prevail” on its anticipation

7 defense, and that a person of skill in the art would be motivated to combine Schaffer and Hartley,

8 rendering Inari’s patent claim invalid for obviousness. Id. This analysis is persuasive for

9 purposes of the preliminary injunction analysis because there are no relevant differences between

10 the related patent considered by the PTAB and the ’921 Patent claims asserted here. See DNA

11 Genotek Inc. v. Spectrum Sols. L.L.C., No. 16-cv-1544-JLS (NLS), 2016 WL 8738225, at *3 (S.D.

12 Cal. Oct. 6, 2016) (holding that IPR institution on similar patent raised a substantial question of

13 validity). Inari does not dispute the similarities between the ’011 Patent claims analyzed by the

14 PTAB and claim 1 of the ’921 Patent asserted here, and acknowledges that the patents are in the

15 same family and share a common patent application. Inari Supp. Br. at 3, ECF No. 97. Inari does

16 argue that claim 10 of the ’921 Patent is narrower than the claims analyzed by the PTAB because

17 it requires not one but two actuators, filaments, and biasing structures. Id. at 5. This argument is

18 not persuasive because Schaffer alone discloses these elements too, as shown below:

19

20

21

22

23

24

25

26

27

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2

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12 Accordingly, the Court finds that Imperative Care has raised a substantial question of

£ 13 || validity as to the asserted ’921 Patent claims. The Court’s conclusion rests on both the PTAB’s

v 14 || analysis and the Court’s own review of the arguments raised before the PTAB and in Inari’s

15 motion. Either the anticipation or obviousness challenge alone is sufficient to preclude Inari from

a 16 showing a likelihood of success. Therefore, Inari has not shown a likelihood of success as to

17 || claims 1 and 10 of the ’921 Patent.

4 18 2. The ’910 Patent

19 The Court turns to Imperative Care’s invalidity arguments with respect to asserted claim 1

20 || of the °910 Patent. The ’910 patent claims an aspiration system for intravascular removal of clot

21 material for treating PE. Asserted claim | is recited below, with key limitations underlined for

22 || emphasis:

23

24

25

26

27

28 || |? Imperative Care Supp. Br. at 5, ECF No. 89.

1. A clot treatment system for treating clot material comprising a pulmonary

1

embolism in a vasculature of a patient, comprising:

2 a first clot aspiration assembly, including:

3 a first catheter;

4 a first pressure source; and

a first fluid control device between the first catheter and the first pressure source,

5

wherein the first fluid control device is movable between (a) a first position in

6

which the first pressure source is fluidly disconnected from the first catheter and

7 (b) a second position in which the first pressure source is fluidly connected to the

first catheter,

8

wherein the first pressure source is configured to generate vacuum pressure while

9 the first fluid control device is in the first position, and wherein, upon movement

of the first fluid control device from the first position to the second position, the

10

vacuum pressure is applied to the first catheter to generate suction at a distal

11 portion of the first catheter; and

a second clot aspiration assembly, including:

12

a second catheter advanceable through the first catheter, wherein the second

13 catheter has a distal portion, wherein the second catheter has a size of 16 French

14 or greater, and wherein the second catheter is shaped to be intravascularly

advanced through the vasculature of the patient such that the distal portion of the

15 second catheter is positioned proximate to the pulmonary embolism;

16 a second pressure source; and

17 a second fluid control device between the second catheter and the second pressure

source, wherein the second fluid control device is movable between (a) a first

18 position in which the second pressure source is fluidly disconnected from the

second catheter and (b) a second position in which the second pressure source is

19

fluidly connected to the second catheter,

20 wherein the second pressure source is configured to generate vacuum pressure

while the second fluid control device is in the first position, and

21

wherein, upon movement of the second fluid control device from the first

22

position to the second position, the vacuum pressure is applied to the second

23 catheter to generate suction at the distal portion of the second catheter to aspirate

blood and at least a portion of the pulmonary embolism into the second catheter.

24

25 ’910 Patent at 35:52-36:34. Image 8 below illustrates the telescoping catheters:

26

27

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v 14 Imperative Care’s invalidity arguments as to the °910 Patent focus on the combination of

15 || two prior art references: Garrison and Laub.'° During prosecution of the 910 Patent, the Patent

16 || Examiner considered Garrison, but Laub was not presented. Garrison discloses a system to

= 17 aspirate blood clots from a patient’s vasculature — specifically, cerebral occlusions. The Patent

4 18 || Examiner concluded that Garrison discloses many of the limitations of claim 1 of the □□□□ Patent.

19 || See Brown Dep. Tr. 93:12-101:3, ECF No. 85-4 (Inari’s expert agreeing with these conclusions).

20 || However, the Patent Examiner concluded that Garrison did not teach telescoping of larger and

21 smaller catheters, nor did it teach two claim limitations that Inari added during prosecution.

22 || Brown Decl. {| 102-104. Specifically, Garrison did not disclose a system “for treating clot

23 || material comprising a pulmonary embolism” or that the second (smaller) catheter “has a size of 16

24 || French or greater.” Jd. A diagram illustrating the Garrison aspiration system is shown below in

25 || Image 9.

26

27 || 4 See Brown Decl. 96.

28 ‘5 Imperative Care has raised these same arguments in an IPR petition before the PTAB, and that

petition is pending.

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Z 18 Imperative Care persuasively argues that Garrison does, in fact, disclose telescoping

19 || catheters,'’ and that Laub supplies the two missing limitations from Garrison — that is, the use of

20 the system for PE, and the use of a catheter sized 16F or larger. Laub, like Garrison, discloses a

21 system for removing blood clots, but unlike Garrison, it specifically discloses that the system may

22 || be used “to remove clots from patients suffering from or at risk of pulmonary embolism.” Opp.

23 || Ex. 1021 95, ECF No. 36-16. Laub also specifically discloses the use of catheters with a “French

24 size of at least 16.” Id. ¥ 28.

25

26

16

Opp. at 15.

27 '7 See Garrison, Opp. Ex. 29 54, ECF No. 24-36 (“A second, smaller diameter catheter may be

2g || inserted through the first catheter or exchanged for the first catheter if more distal access is desired

and not possible with the initial catheter.”).

1 Imperative Care also persuasively argues that a person of ordinary skill in the art would be

2 motivated to combine Garrison’s aspiration system for treating cerebral blood clots with Laub’s

3 teaching of an aspiration method for treating PE using larger-sized catheters, specifically 16F as

4 claimed by the ’910 Patent. These two prior art references are in the same field as Inari’s claimed

5 invention – that is, systems and methods for removing blood clots from a patient’s vasculature.

6 The closeness in field between the prior art references and the ’910 Patent supports Imperative

7 Care’s obviousness position. Imperative Care’s position is further supported because Garrison

8 discloses nearly all of the limitations of the ’910 Patent, and Laub alone discloses the few

9 remaining limitations. Moreover, Laub expressly discloses the application to PE.

10 Inari stresses that there are significant differences between systems and methods used for

11 removing clots from smaller vessels (as in Garrison) and those used for larger vessels, as in the

12 case of DVT and PE. But these differences do not mean that a person of ordinary skill in the art

13 would lack motivation to combine Garrison and Laub to use larger-sized catheters to treat PE.

14 Indeed, Inari’s expert witness acknowledged that an engineer of ordinary skill in the art could

15 draw from her experience removing clots from smaller-diameter vessels when developing systems

16 and methods for treating DVT and PE. See Brown Dep. Tr. 207:5-20, 211:15-212:3.

17 Additionally, Imperative Care has submitted evidence that other companies in the thrombectomy

18 market have developed PE treatment systems by adapting aspiration catheters used to remove

19 smaller clots. Strange Dep. Tr. 31:19-25, 119:17-24, ECF No. 85-2 (testifying that competitors,

20 such as Penumbra, took the “same core technology” used for neurovascular applications “and

21 repurposed them to be used in veins”). This evidence that competitors were motivated to adapt

22 other aspiration systems to treat PE undermines Inari’s claims of non-obviousness based on

23 objective evidence.18

24

25

18 Inari argues that the PTAB’s decision to deny institution of IPR on a related patent undermines

Imperative Care’s position here. See PTAB Decision Denying Institution of IPR, ECF No. 67-1

26

(denying institution as to U.S. Patent No. 11,744,691 (’691 Patent)). The Court is not persuaded.

The PTAB’s analysis of the ’691 Patent focused on claim limitations that are not present in claim

27

1 of the ’910 Patent. Id. at 25. Additionally, the PTAB primarily addressed whether Garrison

1 In sum, Imperative Care has raised substantial questions as to the validity of all patent

2 claims asserted in this motion. Inari has not shown that these challenges lack substantial merit

3 and, therefore, it has not shown a likelihood of success.

4 B. Likelihood of Irreparable Harm

5 Even when a movant establishes a likelihood of success on the merits, a court may not

6 infer a likelihood of irreparable harm. Robert Bosch LLC v. Pylon Mfg. Corp., 659 F.3d 1142,

7 1148-49 (Fed. Cir. 2011). Instead, the movant “must show it is likely to suffer irreparable harm if

8 the injunction is not granted and establish a causal nexus between the alleged infringement and the

9 alleged harm.” Natera, 106 F.4th at 1378 (citing Luminara Worldwide, LLC v. Liown Elecs. Co.,

10 814 F.3d 1343, 1352 (Fed. Cir. 2016)). Here, the Court finds that Inari has not shown a likelihood

11 of irreparable harm, nor that there is a causal nexus between the alleged infringement and Inari’s

12 claimed harm.

13 1. Irreparable harm

14 Harm is irreparable if it cannot be compensated by a final judgment – assuming that the

15 plaintiff ultimately prevails on the merits. To be irreparable, harm must be “imminent and not

16 remote or speculative.” Boardman v. Pac. Seafood Grp., 822 F.3d 1011, 1022 (9th Cir. 2016); see

17 also Koninklijke Philips N.V. v. Thales DIS AIS USA LLC, 39 F.4th 1377, 1380 (Fed. Cir. 2022)

18 (similar). Irreparable harms typically are not quantifiable, and thus “cannot be adequately

19 compensated” with a damages award. Natera, 106 F.4th at 1378; see also Douglas Dynamics,

20 LLC v. Buyers Prods. Co., 717 F.3d 1336, 1344 (Fed. Cir. 2013). By contrast, monetary losses

21 alone, “however substantial,” are “not enough.” Sampson v. Murray, 415 U.S. 61, 90 (1974).

22 “The possibility that adequate compensatory or other corrective relief will be available at a later

23 date, in the ordinary course of litigation, weighs heavily against a claim of irreparable harm.” Id.;

24 see also Goldie’s Bookstore, Inc. v. Super. Court, 739 F.2d 466, 471 (Fed. Cir. 1984) (same).

25 Many factors may be relevant to determine whether patent infringement is likely to cause

26 irreparable harm to a patent holder. Unchecked infringement in a nascent and fast-developing

27 market can cause irreparable harm – for example, if the patent holder is unable to establish itself,

1 CellzDirect, Inc., 664 F.3d 922, 931 (Fed. Cir. 2012) (“During the growth stage of a product, it is

2 particularly crucial to be able to distinguish oneself from competitors . . . and [to]

3 establish[]leadership in the market.”); see also Illumina, Inc. v. Qiagen, N.V., 207 F. Supp. 3d

4 1081, 1093 (N.D. Cal. 2016) (similar). The “nature of the competition between the parties

5 undoubtedly” is relevant, too. Robert Bosch LLC, 659 F.3d at 1150-51. “[T]he existence of a

6 two-player market may well serve as a substantial ground for granting an injunction – e.g.,

7 because it creates an inference that an infringing sale amounts to a lost sale for the patentee.” Id.

8 at 1151. The presence of additional competitors, by itself, does not weigh against granting

9 preliminary relief. Id.

10 Here, Inari primarily relies upon future lost sales, price erosion, and lost market share to

11 show a likelihood of irreparable harm. With respect to lost sales, Inari acknowledges that

12 Imperative Care’s sales to date are “very small.” Strange Dep. Tr. 58:7-18. Inari claims that nine

13 of its hospital customers enrolled patients in Imperative Care’s Symphony PE study. Hykes Decl.

14 ¶ 26. But the use of Symphony in clinical studies is not infringement, 35 U.S.C. § 271(e)(1), and

15 in any event, the potential harm from these limited sales is negligible. Inari also claims that there

16 have been “dozens of Symphony cases” for treating DVT, Hykes Decl. ¶ 23, but these sales, too,

17 are de minimis. Inari projects that Imperative Care will make substantial future sales “over the

18 next few years.” Id. ¶ 30. Even if these lost sales were sufficiently imminent and non-speculative,

19 they can be compensated with a damages award, and therefore they do not establish irreparable

20 harm. Metalcraft of Mayville, Inc. v. Toro Co., 848 F.3d 1358, 1368 (Fed. Cir. 2017) (“Evidence

21 of potential lost sales alone does not demonstrate irreparable harm.”); see also Celsis In Vitro, 664

22 F.3d at 930 (“[T]he irreparable harm inquiry seeks to measure harms that no damages payment,

23 however great, could address.”).

24 With respect to price erosion, the record does not support that Imperative Care frequently

25 undercuts Inari on price. See Scott Decl. ¶ 27. Price comparisons between the companies’

26 products are difficult and “depend[] on many factors.” Id. ¶ 24. Imperative Care uses an a la

27 carte pricing strategy for the components of the Symphony system, and a physician may combine

1 examples). Based on typical cases, Symphony and Inari’s devices are priced comparably.

2 Compare id., with Hykes Decl. ¶ 27 (summarizing Inari’s pricing). In any event, sales of

3 Symphony are not currently affecting Inari’s pricing or profitability given Imperative Care’s “very

4 small” market share. Strange Dep. Tr. 58:7-18.

5 Even if Inari has to compete on price in the future, there is no evidence that price erosion

6 would be irreparable if Inari later obtains a permanent injunction excluding sales of Symphony.19

7 Inari’s assertion as to price erosion is unsupported. See Hykes Decl. ¶ 30; see also id. ¶ 27

8 (similar). This conclusory assertion is not enough to establish a non-speculative likelihood of

9 irreparable price erosion. Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., 967 F.3d 1339,

10 1349 (Fed. Cir. 2020) (holding that bare assertions of irreparable harm based on price erosion are

11 “never sufficient”); cf. Celsis In Vitro, 664 F.3d at 930 (affirming preliminary injunction premised

12 on price erosion where movant presented “unrebutted expert testimony,” fact witness testimony,

13 specific financial records, and evidence of competitor’s “significantly discounted prices” and

14 specific lost sales).

15 With respect to lost market share, there is no doubt that Inari presently holds a dominant

16 share of the market for mechanical thrombectomy devices in the United States. Strange Decl. ¶ 10

17 (discussing market share figures). Inari is the market leader with respect to both PE and, to a

18 lesser extent, DVT. Id. Inari has maintained its dominant share despite Imperative Care’s entry,

19 and Inari’s losses to date have been to other competitors, primarily Penumbra. Nalbone Decl.

20 ¶ 17; see also Strange Dep. Tr. 20:16-23, 21:15-21. By contrast, Imperative Care does not have

21 “any share in PE” given that Symphony was only just cleared by the FDA, and even with respect

22 to DVT, its share is “very de minimis.” Strange Dep. Tr. 57:14-23. Even assuming that

23 Imperative Care establishes a greater foothold while this litigation progresses, Inari has not shown

24 that any potential lost share would be irreparable. Instead, the market for mechanical

25 thrombectomy devices has been dynamic, with shares fluctuating as competitors introduce new

26

27

19 On this point, it is unclear whether Inari would reduce its price in response to continued

1 products. See Strange Dep. Tr. 64:9-13. Additionally, the market is “highly underpenetrated”

2 because most PE and DVT cases are still treated with anticoagulants and thrombolytics. Id. 66:5-

3 24. Therefore, there is opportunity for both Inari and Imperative Care to expand sales, without

4 Inari losing its relative share.

5 In sum, Inari has not shown that it will likely be forced to irreversibly lower its prices, or

6 that it will lose market share that it cannot recover. Thus, Inari has not shown a likelihood that it

7 will suffer irreparable harm in the absence of a preliminary injunction.20

8 2. Causal nexus

9 Even if Inari had shown a likelihood of irreparable harm, its motion would still fail for lack

10 of a causal nexus between that harm and Imperative Care’s alleged infringement. The purpose of

11 the causal nexus requirement is to distinguish between “irreparable harm caused by patent

12 infringement and irreparable harm caused by otherwise lawful competition – e.g., sales [that]

13 would be lost even if the offending feature were absent from the accused product.” Apple Inc. v.

14 Samsung Elecs. Co., 735 F.3d 1352, 1361 (Fed. Cir. 2013) (“Apple III”). To satisfy the causal

15 nexus requirement, the patent holder must show that the infringing features of the accused product

16 (here, Symphony) “drive consumer demand.” Apple Inc. v. Samsung Elecs. Co., 809 F.3d 633,

17 641-42 (Fed. Cir. 2015) (“Apple IV”). The patent holder need not show that “the infringing

18 features were the exclusive or predominant reason why consumers bought” the accused products.

19 Id. at 642. Instead, it is sufficient if there is “some connection” between the patented features and

20 the demand for the alleged infringer’s products. Id.

21 Here, the record does not support Inari’s claim that the allegedly infringing aspects of

22 Symphony drive consumer demand. Inari did not submit any direct evidence (e.g., customer

23 declarations), and its other evidence is unhelpful.21 With respect to the hemostasis valve, Inari

24

25 20 Inari also fails to show that Imperative Care’s continued sales of Symphony are likely to cause

Inari loss of goodwill or reputational harm. Inari concedes that there has been no head-to-head

26 clinical study of the companies’ devices. Hykes Dep. Tr. 270:2-271:13, ECF No. 85-3. Thus,

there is no evidence that Symphony sales will somehow tarnish the reputation of Inari’s

27 technology, even if customers perceive Symphony as a copycat of Inari’s devices.

1 testified that one doctor liked “[t]he buttons, and how easy they were to use.” Hykes Dep.

2 Tr. 73:23-75:23 (“Q. The buttons. Anything else other than the buttons? A. No.”). But the

3 specific buttons that Inari uses are not claimed by the ’921 Patent. Inari also testified that its

4 customers likely do not know the details about the construction of the hemostasis valve because

5 “it’s obscured in the device. It’s opaque plastic.” Merritt Dep. Tr. 207:25-208:9, ECF No. 85-5.

6 Similarly, the telescoping feature claimed by the ’910 Patent has been a negligible draw for

7 Symphony customers. Until recently, Symphony was only cleared for use in DVT procedures,

8 and the “vast majority” of those procedures used only one Symphony catheter. Scott Decl. ¶ 9

9 (stating that only 1.5% of cases used the 16F and 24F catheters simultaneously).22 Therefore, the

10 causal nexus between the accused features of Symphony and its modest sales to date is lacking.

11 Genband US LLC v. Metaswitch Networks Corp., 861 F.3d 1378, 1384 (Fed. Cir. 2017) (“If all but

12 an insignificant number of purchases from the infringer would have been made even without the

13 infringing feature, the causal connection to the asserted lost-sale-based injury is missing.”).

14 In addition to considering consumer purchasing behavior, courts may consider whether the

15 alleged infringer copied aspects of the patent holder’s product. “[E]vidence of copying does not,

16 by itself, establish a causal nexus.” Apple IV, 809 F.3d at 642. But copying may indicate that the

17 alleged infringer expects a particular feature to drive demand. Id. Here, Inari’s claims of copying

18 are conclusory and do not satisfy the causal nexus requirement. See Strange Dep. Tr. 117:19-22

19 (“[Q.] So you really have no basis to know where [Imperative Care] learned the concepts

20 incorporated in the Symphony device; correct? A. I have no way of knowing.”); Hykes Dep.

21 Tr. 152:22-153:1 (“Q. But you have no document, witness, any piece of evidence that actually can

22 show that [Imperative Care] got the idea to copy a feature or attribute of an Inari device, do you?

23 A. No.”). Inari also argues that Imperative Care submitted a FOIA request to obtain information

24

Decl. ¶¶ 9-17, ECF No. 36-43. This evidence is anecdotal but adds some support to Imperative

25

Care’s position that a causal nexus is lacking.

26 22 To be clear, whether sales of Symphony infringe the ’910 Patent is a separate question from the

causal nexus inquiry. Here, the Court focuses on whether there is some connection between the

27 allegedly infringing features of Symphony and customer demand for it. If almost no procedures

use telescoping, and if Symphony is primarily used to treat DVT, these facts are relevant to the

1 about its FDA application for FlowTriever, but this is not proof of copying. Hykes Decl. ¶ 20

2 (acknowledging that “FOIA requests are relatively common in [this] industry, and Inari has also

3 made them”).

4 In sum, Inari has failed to satisfy both the irreparable harm and causal nexus requirements

5 for obtaining a preliminary injunction.

6 C. Balance of the Hardships and the Public Interest

7 Finally, the Court considers the last two Winter elements: the balance of the hardships and

8 the public interest.23 “A court must ‘balance the interests of all parties and weigh the damage to

9 each’ in determining the balance of the equities.” CTIA - The Wireless Ass’n v. City of Berkeley,

10 Cal., 928 F.3d 832, 852 (9th Cir. 2019) (quoting Stormans, Inc. v. Selecky, 586 F.3d 1109, 1138

11 (9th Cir. 2009)). “[T]he public interest inquiry primarily addresses impact on non-parties rather

12 than parties.” hiQ Labs, Inc. v. LinkedIn Corp., 31 F.4th 1180, 1202 (9th Cir. 2022) (quoting

13 Bernhardt v. Los Angeles Cnty., 339 F.3d 920, 931-32 (9th Cir. 2003)).

14 The Court finds that Imperative Care presents a strong case that it would suffer hardship

15 from a preliminary injunction. Imperative Care has made substantial investments in developing

16 Symphony, and it continues to invest additional resources to improve the device. Nalbone Decl.

17 ¶¶ 11, 19 (detailing Imperative Care’s investments). Imperative Care is at an early stage of entry

18 into the mechanical thrombectomy market, and blocking sales of Symphony now would have dire

19 consequences for its business. Id. ¶¶ 20-22. The proposed injunction would block Imperative

20 Care’s only product in the mechanical thrombectomy market. Inari even acknowledges that

21 Imperative Care “will be harmed from an injunction” and may be forced out of the market, “at

22 least in the short term” until it can develop and obtain FDA clearance for another device. Mot. at

23 33. By contrast, although Inari may face competition from Imperative Care while this litigation

24 progresses, it will not likely face irreparable harm. Therefore, the balance of hardships tips in

25 Imperative Care’s favor. See Ill. Tool Works, Inc. v. Grip-Pak, Inc., 906 F.2d 679, 683 (Fed. Cir.

26

23 In light of the Court’s findings as to the first two elements, the Court need not reach the final

27

two elements. Polymer Techs., 103 F.3d at 973-74; see also Reebok Int’l Ltd. v. Baker, Inc., 32

1 1990) (“The hardship on a preliminarily enjoined manufacturer who must withdraw its product

2 || from the market before trial can be devastating.”’).

3 The Court finds that the public interest element is neutral. Inari is correct that enforcing

4 || patent rights, and thereby encouraging innovation, is in the public interest. See Sanofi-Synthelabo

5 v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed. Cir. 2006) (“We have long acknowledged the

6 || importance of the patent system in encouraging innovation.”). But this argument “has less force

7 here because there are serious questions regarding the validity of the asserted claims” in Inari’s

8 patents. DNA Genotek, 2016 WL 8738225, at *5.

9 TK

10 Inari has not met its burden to show that any of the Winter elements — much less all of

11 them — favor a preliminary injunction. Accordingly, the Court cannot award Inari the

12 || extraordinary relief of an order blocking Imperative Care from the mechanical thrombectomy

5 13 || market while this litigation is pending.

14 || Iv. CONCLUSION

15 For the foregoing reasons, Inari’s motion for a preliminary injunction is DENIED.

a 16 IT IS SO ORDERED.

3 17 Dated: September 29, 2025

18

19

Eumi K. Lee

20 United States District Judge

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