Penumbra, Inc. v. RapidPulse, Inc.

• Docket Number: IPR2021-01466,Patent 10,531,883 B1
• Decision Date: 10 March 2023
• Parties: PENUMBRA, INC., Petitioner, v. RAPIDPULSE, INC., Patent Owner.
• Court: Patent Trial and Appeal Board

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PENUMBRA, INC., Petitioner,
v.
RAPIDPULSE, INC., Patent Owner.

No. IPR2021-01466

Patent 10,531,883 B1

United States Patent and Trademark Office, Patent Trial and Appeal Board

March 10, 2023

Determining All Claims Unpatentable 35 U.S.C. § 318(a)

Before JASON W. MELVIN, DAVID COTTA, and JAMIE T. WISZ, Administrative Patent Judges.

JUDGMENT

FINAL WRITTEN DECISION

WISZ, Administrative Patent Judge

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I. INTRODUCTION

A. Background

Penumbra, Inc. ("Petitioner") filed a Petition (Paper 2, "Pet.") requesting an inter partes review of claims 1-18 of U.S. Patent No. 10,531,883 B1 (Ex. 1001, "the '883 patent"). Petitioner supported its Petition with the Declarations of Brian Brown and Ian Ross, MD (Exs. 1005, 1023). RapidPulse, Inc. ("Patent Owner") filed a Preliminary Response (Paper 6, "Prelim. Resp.") along with the Declarations of Ender Finol, PhD, and Michael Chen, MD (Exs. 2001, 2003). Upon consideration of the Petition, the Preliminary Response, and the preliminary evidence of record, we determined that Petitioner had demonstrated a reasonable likelihood that it would prevail with respect to at least one of the challenged claims of the '883 patent (Paper 7, "Institution Decision" or "Inst. Dec."). Thus, we instituted review with respect to all of the challenged claims.

Patent Owner filed a Patent Owner's Response (Paper 14, "PO Resp.") with additional Declarations from Dr. Finol and Dr. Chen (Exs. 2014, 2015). Petitioner filed a Reply (Paper 22, "Pet. Reply"), supported by the Supplemental Declaration of Brian Brown (Ex. 1030). Patent Owner filed a Sur-Reply (Paper 27, "PO Sur-Reply").

An oral hearing was held on December 14, 2022, and a transcript of the hearing is included in the record (Paper 33, "Tr.").

We have jurisdiction under 35 U.S.C. § 6. After considering the parties' arguments and supporting evidence, we conclude that Petitioner has proven by a preponderance of the evidence that claims 1-18 of the '883 patent are unpatentable. 35 U.S.C. § 316(e).

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B. Real Parties-in-Interest

Petitioner identifies Penumbra, Inc. as the real party-in-interest. Pet. 1. Patent Owner identities RapidPulse, Inc. as the real party-in-interest. Paper 4, 1.

C. Related Proceedings

The parties do not identify any other proceedings involving the '883 patent.

D. The '883 Patent

The '883 patent, titled "Aspiration Thrombectomy System and Methods for Thrombus Removal with Aspiration Catheter," is directed to an aspiration thrombectomy system that may be used for treatment of ischemic strokes caused by a blood clot that blocks or plugs a blood vessel in the brain. Ex 1001, code (54), 1:28-3:6. We reproduce Figure 47 from the '883 patent below.

(Image Omitted)

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Figure 47 illustrates an embodiment of the aspiration thrombectomy system 600 of the '883 patent that operates in a Rapid Onset Aspiration Repeater ("ROAR") mode. Ex. 1001, 33:22-24; 35:19-22; Fig. 47. The system includes a vacuum source 610 fluidically connected to the input of a controllable vacuum valve 620, which in turn is fluidically connected to the vacuum input of a manifold 630. Id. at 35:22-28. A vent fluid source 640 containing a vent liquid 642 is fluidically connected to a controllable vent valve 650. Id. at 35:29-31. A ROAR catheter 660, configured to operate in relatively small vessels, "defines a working lumen 662 fluidically connecting a distal end 664 thereof to a proximal manifold connector assembly 670 at a proximal end of the ROAR catheter 660." Id. at 35:55- 58.

Operation of the aspiration thrombectomy system 600 occurs through a controller 700 that "selectively opens and closes the vacuum and vent valves 620, 650 such that, when the vacuum valve 620 is opened, the vacuum source 610 is fluidically connected to the liquid column in the lumen 662 and, when the vent valve 650 is opened, vent liquid 642 is fluidically connected to the liquid column in the lumen 662." Ex. 1001, 36:39-45. Controller 700 controls the timing of these valves to "change a level of vacuum at the distal end 664 and prevent the distal portion of the liquid column in the lumen 662 from exiting the distal end 664- substantially no forward flow." Id. at 36:45-49.

During a ROAR cycle, "suction is applied to the clot by rapidly opening a valve, causing a rapid rise in vacuum pressure." Id. at 40:32-34. The source of suction is then turned off and a vent fluid source is rapidly opened, which "relieves the vacuum present in the catheter 660, which again

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rapidly changes the pressure applied to the clot." Id. at 40:34-37. In some embodiments of the ROAR cycle, both the vacuum valve 620 and the vent valve 650 are closed at the same time before the vent valve is opened. Id. at 6:11-17, 43:17-44:10, Tables 1, 4, 5. "The vent valve 650 is then rapidly closed and the vacuum valve 620 is rapidly opened." Id. at 40:37-38. "This cycle is repeated multiple times per second." Id. at 40:39.

According to the '883 patent, the "ROAR effect overcomes the static friction of a clot that is fixed or 'stuck' on the catheter tip while under constant suction" by "provid[ing] an oscillating/alternating displacement that causes the clot to 'shuttle' back and forth to overcome static frictional force." Id. at 7:9-14. With ROAR, "there is a morcellation of the clot that overcomes different clot morphologies as well as overriding volume and diameter constraints of the small, fixed luminal volume dictated by the micro-anatomic environment." Id. at 7:14-18.

E. Illustrative Claims

Petitioner challenges claims 1-18 of the '883 patent. Claim 1, which is an independent claim, is illustrative of the challenged claims, and is reproduced below:

1. [Pre] A clot removal system, comprising:

[a] a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion;

[b] a controllable vacuum valve;

[c] a vacuum source fluidically connected to the vacuum valve;

[d] a controllable vent valve having a vent liquid input;

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[e] a vent fluid source containing a vent liquid and fluidically connected to the vent valve to retain the vent liquid at the vent fluid input;

[f] a manifold connected to the catheter, to the vacuum valve, and to the vent valve, the manifold fluidically connecting the proximal portion of the liquid column in the lumen: to the vacuum source through the vacuum valve; and to the vent fluid source through the vent valve;

[g] a controller connected to the vacuum valve and the vent valve and configured to selectively open and close the vacuum valve and the vent valve such that: responsive to opening the vacuum valve, the vacuum source is fluidically connected to the liquid column in the lumen; and responsive to opening the vent valve, the vent fluid source is fluidically connected to the liquid column in the lumen,

[h] the controller configured to cyclically open and close the vacuum valve and the vent valve to: change a level of vacuum at the distal end; and

[i] prevent forward flow of the distal portion out from the distal end during each cycle.

Ex. 1001, 55:5-35 (annotated with bracketed letters). Challenged claims 2-17 depend from claim 1, either directly or indirectly. Challenged claim 18 is independent and is similar to claim 1 except for the last few limitations. The underlined text below highlights the additions to claim 18:

. . . [18.h] the controller configured to cyclically open and close the vacuum valve and the vent valve in a repeated cycle comprising a double-closed state in which the vacuum valve is closed and the vent valve is closed to: change a level of vacuum at the distal end; and

[18.i] prevent forward flow of the distal portion out from the distal end during each cycle, and

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[18.j] a time of the double-closed state is not greater than approximately 30 ms.

Id. at 56:40-57:7.

F. Instituted Grounds of Unpatentability

We instituted trial to determine whether claims 1-18 of the '883 patent are unpatentable based on the following grounds:

Ground	Claims Challenged	35 U.S.C. §[1]	Reference(s)/Basis
1	1-12, 15, 16, 18	103	Teigen,[2] Grey [3]
2	2, 3, 6-9, 18	103	Teigen, Grey, Rubenstein [4]
3	13, 14	103	Teigen, Grey, Yang [5]
4	17	103	Teigen, Grey, Matteo [6]

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II. ANALYSIS

A. Principles of Law

To prevail in its challenges to the patentability of all claims of the '883 patent, Petitioner must demonstrate by a preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e) (2018); 37 C.F.R. § 42.1(d) (2019). "In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable." Harmonic Inc. v. Avid. Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); see also 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify "with particularity . . . the evidence that supports the grounds for the challenge to each claim"). That burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015); see also In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364, 1375-78 (Fed. Cir. 2016) (discussing the burden of proof in inter partes review).

B. Person of Ordinary Skill in the Art

We consider the asserted grounds of unpatentability in view of the understanding of a person of ordinary skill in the art ("POSA" or "POSITA"), and thus begin with the level of ordinary skill in the art. The level of ordinary skill in the art is "a prism or lens through which . . . the Board views the prior art and claimed invention" to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).

The parties...