Federal Circuit Finds Heart Valve Support Unpatentable

The Federal Circuit has affirmed a Patent Trial and Appeal Board (PTAB) finding that patent claims for a type of prosthetic valve support were unpatentable as obvious.

Cardiovalve Ltd. owns US Patent No. 10,226,341, titled “Implant for Heart Valve.”

The patent describes

a prosthetic valve support . . . for facilitating minimally invasive (e.g., transcatheter and/or transluminal) implantation of a prosthetic valve at a native valve of a subject.

Independent claim 1 of the patent recites:

1. Apparatus for use at a native valve of a subject, the native valve including at least a first native leaflet and a second native leaflet, the apparatus comprising:

an implant, comprising:

an annular portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening, and

at least one leaflet clip:

(i) coupled to the annular portion…

(Emphasis added by court.)

Edwards Lifesciences successfully petitioned the US Patent and Trademark Office (USPTO) to institute an inter partes review of certain claims of the patent under 35 U.S.C. §§ 311–19.

The USPTO’s Patent Trial and Appeal Board (PTAB or the Board) determined that all of the challenged claims were unpatentable for obviousness over a prior patent (Goldfarb).

Under 35 U.S. Code § 103,

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.

The Goldfarb patent also discloses a device for stabilizing heart valve leaflets.

The Golfarb patent

includes flaps, …which restrict upward motion of the leaflets to better enable the proximal and distal elements to grasp the leaflets. Additionally, Goldfarb discloses that “[o]nce the leaflets have been grasped, the flaps . . . may be removed . . . or may be left behind to assist in holding the leaflets.”

(Emphasis added by court.)

In fact, as the court noted,

Cardiovalve does not dispute that Goldfarb discloses every limitation of the claims of the ʼ341 patent other than the requirement that the implant comprise “at least one leaflet clip” “coupled to the annular portion.” Further, Cardiovalve accepts that each of Goldfarb’s pairs of proximal and distal elements constitutes a “leaflet clip,” that each of Goldfarb’s flaps constitutes or contains an “annular portion,” and that any direct or indirect attachment of Goldfarb’s proximal and distal elements to Goldfarb’s flaps is a “coupl[ing].”

Thus, the PTAB found that Goldfarb makes the disputed patent claim element obvious.

On appeal, Cardiovalve’s only challenge was that the Board erred in determining that it would have been obvious to a relevant artisan to attach, either directly or indirectly, Goldfarb’s flaps to its proximal and distal elements.

The court rejected this argument.

As the court noted, “Obviousness is a question of law based on underlying findings of fact.”

The court cited the case of KSR International Co. v. Teleflex Inc., which states,

When there is a design need or market pressure to solve a problem, and there are a finite number of identified, predictable solutions, a [relevant artisan] has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance, the fact that a combination was obvious to try might show that it was obvious under § 103.

Relying on Goldfarb’s statement that the flaps “may be left behind,” the Board found (logically) that the flaps may be left behind.

It wasn’t disputed that leaving the flaps behind would necessitate that they be attached to something fixed.

The court read the Board’s opinion to find, and Cardiovalve didn’t dispute, that Goldfarb’s flaps if left behind, must be attached either “(1) to the fixation device [implant] or (2) to the heart tissue.”

The Board found that.

even assuming that one option for a [relevant artisan] was to attach the flaps to the heart wall, it would have also been obvious to attach the flaps to the fixation device as a predictable option out of a number of options.

An expert witness testifying for Edwards explained “why a relevant artisan would know to attach the flaps to the implant device and why such attachment would be expected to succeed.”

The court noted that

Edwards argued… that a relevant artisan would have found it obvious to attach Goldfarb’s flaps to its fixation device (and therefore indirectly to its proximal and distal elements) because the flaps, if left behind, had to be attached somewhere, and this was an obvious location.

However,

In response, Cardiovalve pointed to another solution to the attachment problem, namely, attachment to heart tissue (valve annulus or wall), and urged that a relevant artisan would have used that solution.

The court explained,

In its obvious-to-try analysis, the Board then said that it need not find that the solution argued for by Edwards was the only obvious one because it was enough that, even if Cardiovalve’s submissions about alternative attachment locations were to be accepted, the Edwards-urged solution was an obvious one among two or three a relevant artisan would have known.

Said the court,

It is the essential point of the KSR passage relied on by the Board that when a relevant artisan would have recognized a problem, a consideration of whether only a small number of solutions existed is a natural part of an evaluation of whether a patent-claimed solution would have been obvious. The Board’s undertaking such consideration here was, therefore, a legitimate exercise of its duty to evaluate whether Edwards was right or wrong about the position Edwards consistently maintained—that attachment to the implant would have been obvious. All the Board did was to credit that position even on the assumption that Cardiovalve was right and that a relevant artisan would have found one or two alternatives obvious as well.