Maquet Cardiovascular Llc v. Abiomed Inc., decided March 21, 2025

Case Name and Citation: MAQUET CARDIOVASCULAR LLC v. ABIOMED INC., 2023-2045, decided March 21, 2025 (United States Court of Appeals for the Federal Circuit)

Appeal from the United States District Court for the District of Massachusetts in No. 1:17-cv-12311-FDS, Judge F. Dennis Saylor, IV.

Issue: Did the District Court err in its construction of certain claim terms in U.S. Patent No. 10,238,783 ('783 patent), specifically regarding the "guide mechanism comprising a lumen" in claim 1 and the "guide wire" terms in claims 1 and 24, by improperly applying the doctrine of prosecution disclaimer?

Holding: Yes. The Federal Circuit held that the District Court misconstrued the claim terms at issue by improperly applying prosecution disclaimer. The court rejected the District Court's constructions, vacated the judgment of non-infringement as to the '783 patent, and remanded the case for further proceedings consistent with its opinion. The judgment of non-infringement regarding U.S. Patent No. 9,789,238 ('238 patent) was left undisturbed as Maquet did not appeal that portion of the judgment.

Main Themes and Important Ideas/Facts:

The '783 Patent and the Prior Art:

• The '783 patent relates to an intravascular blood pump system designed for easier deployment within a patient's circulatory system.

• The patent explains that prior art pumps relied on "supplemental guiding mechanisms," such as large diameter guide catheters, which were "incapable of providing the degree of control necessary to easily negotiate the pump through the tortuous pathways leading up to and into the heart" and consumed valuable vessel space.

• The '783 patent aimed to solve this by employing "integrated guide mechanisms" located on the device itself. These include "over-the-wire," "side-rigger" (or "rapid exchange"), and "guide catheter" type mechanisms.

• Figure 6 depicts the "side-rigger" mechanism, and Figure 3 shows a cross-section of the "over-the-wire" type.

The District Court's Claim Construction and the Stipulation of Non-Infringement:

• The District Court construed three claim terms at issue: "guide mechanism comprising a lumen" (claim 1) and the "guide wire" terms ("guide mechanism is configured to allow a guide wire to slideably advance" in claim 1 and "the guide wire does not pass through the rotor hub or the catheter" in claim 24).

• Regarding "guide mechanism comprising a lumen," the District Court agreed with Abiomed that it included a negative limitation that the "guidewire lumen is not distal to the cannula," based on Maquet's alleged acquiescence during the prosecution of the related '238 patent.

• Regarding the "guide wire" terms, the District Court agreed with Abiomed that these claims included a limitation that "the guide wire does not extend through the free space in between the rotor blades," based on the prosecution history of the '728 patent (a great-great-grandparent of the '783 patent). The District Court found Maquet had "adopted" the examiner's position distinguishing prior art (Völker) on this basis.

• Following these constructions, the parties stipulated that Maquet could not prove infringement of the asserted claims of either the '783 or '238 patents. The District Court entered final judgment of non-infringement based on this stipulation.

The Appeal and the Federal Circuit's Analysis of Prosecution Disclaimer:

• Maquet appealed the District Court's claim constructions of the '783 patent, arguing that the District Court misapplied prosecution disclaimer for all three terms.

• The Federal Circuit reviewed the claim constructions de novo as they were based entirely on intrinsic evidence (prosecution history).

• The court reiterated the high standard for finding prosecution disclaimer, requiring a "clear and unmistakable" disavowal of claim scope by the patentee during prosecution. Ambiguous statements or those amenable to multiple interpretations are insufficient.

"Guide Mechanism Comprising a Lumen" (Claim 1):

• The Federal Circuit found that the District Court erred in relying on the prosecution history of the '238 patent to construe this term in the '783 patent.

• The court emphasized that while the prosecution history of a related patent can be relevant if it addresses a "limitation in common," the limitations at issue here were "dissimilar."

• Claim 1 of the '783 patent recites a "guide mechanism comprising a lumen," without specifying its position or length. In contrast, the relevant claims of the '238 patent claimed an "entire elongate lumen distal to the intravascular blood pump" or "distal to the rotor."

• The court stated: "Here, the claim term at issue is 'guidewire mechanism comprising a lumen' in claim 1 of the ’783 patent. The district court construed this claim term to include the negative limitation 'distal to the cannula.' J.A. 22–23. In so holding, the district court determined that Maquet disclaimed scope during the prosecution of then-pending claims 14 and 22 of the ’238 patent, the parent of the ’783 patent. J.A. 22. This was legal error."

• The Federal Circuit rejected Abiomed's argument that "common subject matter" alone justifies applying prosecution disclaimer, emphasizing that the analysis must focus on the "claim language" and "commonality of limitations."

• The court concluded that a "'guide mechanism comprising a lumen' in claim 1 of the ’783 patent does not contain the limitation of being 'not distal to the cannula.'"

"Guide Mechanism is configured to allow for a guide wire to slideably advance therealong" (Claim 1):

• The Federal Circuit agreed that the prosecution history of claim 15 of the '728 patent (the great-great-grandparent) was relevant because the "guide wire" limitation in both claims was "identical," and the remainder of the claims were "virtually identical" with minor, non-dispositive differences.

• However, the court disagreed with the District Court's finding of a clear and unmistakable disavowal.

• The court stated: "An applicant’s silence in response to an examiner’s notice of allowance will generally not rise to a clear and unmistakable claim disavowal." Maquet's lack of response to the examiner's second notice of allowance in the '728 patent prosecution, which distinguished Völker based on the guide wire threading through rotor blades, did not constitute a disavowal.

• The court also rejected Abiomed's argument that Maquet ratified the examiner's statements during IPR proceedings against the '728 patent. Maquet's statements in the IPR were "broad and vague" and did not specifically disclaim a guide wire running through the free space of the rotor blades in claim 15.

• Furthermore, the Federal Circuit found that Maquet's arguments during the '728 patent prosecution regarding the inoperability of combining prior art references did not clearly disavow the claimed guide wire passing through the rotor blade space. These arguments were more related to the agreed-upon construction that the lumen should not pass through that space.

• The court also rejected Abiomed's arguments based on the '783 patent specification, noting that the specification allows for a removable guide wire and does not manifestly exclude a guide wire passing through the free space between the rotor blades. The agreement that the lumen cannot pass through this space does not logically preclude the temporary passage of the guide wire.

• Therefore, the Federal Circuit rejected the District Court's construction, finding no clear and unmistakable disavowal of a guide wire running through the free space between the rotor blades.

"The guide wire does not pass through the rotor hub or the catheter" (Claim 24):

• The Federal Circuit agreed with Maquet that the claim limitations of claim 24 of the '783 patent and claim 15 of the '728 patent were "sufficiently different" to render the '728 patent's prosecution history irrelevant.

• Claim 24 of the '783 patent recites only the guide wire and requires it not to pass through the rotor hub, a limitation not present in the relevant claims of the '728 patent, which disclosed a "guide mechanism" with a lumen and a guide wire.

• Even if the prosecution history were relevant, the court reiterated its finding that Maquet made no clear disavowal of a guide wire passing through the rotor blade space during the '728 patent prosecution.

• Thus, the Federal Circuit rejected the District Court's construction of the "guide wire" term in claim 24, holding that it does not include the limitation that the guide wire may not pass through the free space of the rotor blades.

Disposition of the '238 Patent:

• The Federal Circuit noted that Maquet did not appeal the portion of the District Court's judgment concerning the '238 patent or raise any arguments about it in their opening brief. Therefore, they declined to reach that portion of the judgment and left it undisturbed, considering the issue waived.

Quotes:

• "'[W]here the patentee has unequivocally disavowed a certain meaning to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the ordinary meaning of the claim congruent with the scope of the surrender.'"

• "'[W]hen the prosecution history is used solely to support a conclusion of patentee disclaimer, the standard for justifying the conclusion is a high one.'"

• "A patentee will only be bound to a disavowal that is both 'clear and unmistakable.'"

• "'The prosecution history of a related patent can be relevant if, for example, it addresses a limitation in common with the patent in suit.'"

• "'[T]he doctrine of prosecution disclaimer generally does not apply when the claim term in the descendant patent uses different language.'"

• "An applicant’s silence in response to an examiner’s notice of allowance will generally not rise to a clear and unmistakable claim disavowal."

• "Statements made by a patent owner during an IPR proceeding can be relied on to support a finding of prosecution disclaimer during claim construction. To invoke the doctrine of prosecution disclaimer to statements made during IPR proceedings, any such statements must be 'both clear and unmistakable.'"

• "A patent specification will narrow claim scope when a patentee (1) acts as his own lexicographer, or (2) disavows scope in the specification or during prosecution. As to disavowals made in the specification, the patentee must limit the claim scope using 'words or expressions of manifest exclusion or restriction.'"

• "An issue that falls within the scope of the judgment appealed from but is not raised by the appellant in its opening brief on appeal is necessarily waived."

  
  

Impact of the Decision:

The Federal Circuit's decision clarifies the application of prosecution disclaimer, emphasizing the need for a clear and unmistakable disavowal of claim scope by the patentee and highlighting the importance of commonality in claim limitations when relying on the prosecution history of related patents. The vacating of the District Court's judgment and remand regarding the '783 patent means that the issue of infringement will need to be re-evaluated based on the Federal Circuit's claim constructions. The decision also reinforces the principle of waiver for issues not raised on appeal.