Federal Circuit Finds Claims Patent Eligible Where Not Directed Solely to Printed Matter

“The CAFC stated that ‘[a] conclusion that mere identification of a device’s own functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine would eviscerate our established case law that ‘simply adding new instructions to a known product’ does not create a functional relationship.’”

On November 10, the U.S. Court of Appeals for the Federal Circuit reversed-in-part and vacated-in-part a decision of the U.S. District Court for the District of Delaware in C R Bard Inc. v. Angiodynamics, Inc. In particular, the CAFC held that that there was substantial evidence in the record to support a jury finding of infringement and willfulness and that the asserted claims were not directed solely to printed matter and were patent eligible under 35 U.S.C. § 101.

District Court Eligibility Analysis

C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard) filed suit against AngioDynamics, Inc. for alleged infringement of Bard’s U.S. Patent Nos. 8,475,417, 8,545,460, and 8,805,478, each of which include claims requiring the presence of a radiographic marker identifying a port as power injectable. AngioDynamics moved to dismiss the complaint on the ground that all claims of the patents-in-suit were ineligible under Section 101, but the district court denied AngioDynamic’s motion as premature. Subsequently, the parties cross-moved for summary judgment on the questions of patent eligibility, novelty, and enablement and the district court concluded that factual disputes remained on all issues and, therefore, denied the motions without prejudice.

Following a trial, the district court issued a written opinion granting AngioDynamics’s motion for judgment as a matter of law (JMOL) of non-infringement and no willful infringement. The court also stated that “the asserted claims were invalid because they were directed to printed matter as ineligible subject matter and were not inventive.” Bard appealed the judgments of non-infringement, no willfulness, and invalidity, including ineligibility under Section 101 to the CAFC.


Federal Circuit Review of Infringement and Invalidity

In concluding that the district court erred in granting JMOL of non-infringement in favor of AngioDynamics, the CAFC rebutted each of three reasons relied upon by the district court in granting JMOL. First, the CAFC explained that although Dr. Clark, an infringement expert, “testified during cross-examination that he believed there was an intent requirement ‘implied’ in the court’s construction of the ‘access port’ terms as ‘structured for power injection,’ this mistake did not undermine the factual basis of his infringement opinion.” The CAFC also explained that the district court erroneously relied on a statement in Wiener v. NEC Electronics, Inc. that an expert’s infringement testimony did not “create a factual dispute” when the opinion “rest[ed]  on  an  incorrect  claim  interpretation.”  The CAFC stated that “even if Dr. Clark assumed that the claims required an additional intent element, nothing in the record suggested that this caused him to disregard the requirements of the asserted claims under the correct construction” and did not make his testimony legally insufficient to support an infringement verdict. Thus, the CAFC concluded that the district court thus erred in granting JMOL on this basis.

In rebutting a second reason relied upon by the district court, the CAFC explained that “although Bard did not conduct its own tests of the Xcela port’s suitability for power injection, Bard was entitled to rely on AngioDynamics’s representations to its customers and to the FDA that the Xcela port was suitable for power injection at the flow rate and pressure required by the claims.” The CAFC noted that the district court nor AngioDynamics provided any reason for why direct testing evidence was required as a matter of law to establish infringement under these circumstances and further noted that the weight assigned to the evidence was question for the jury.

The CAFC also addressed the third reason relied upon by the CAFC in granting JMOL of non-infringement, noting that “even if Bard did not present direct evidence of specific instances in which an entity performed each of the claimed steps of the ’478 patent, there was sufficient circumstantial evidence in the record to support AngioDynamics’s induced infringement of the method claims.”  Thus, the CAFC concluded that the district court erred in granting JMOL of non-infringement as to each of the asserted claims.

Willful Infringement

The CAFC explained that the district court granted judgment of no willful infringement based on its conclusion that Bard failed to show infringement or, alternatively, because “Bard failed to meet its burden as to willfulness because AngioDynamics had obtained written opinions of counsel regarding the invalidity of the asserted claims of the patents-in-suit, and Bard had failed to show that the opinions were ‘drafted by a bad law firm’ or put forth other evidence of willfulness.” The CAFC disagreed with the district court, noting that Bard’s evidence that AngioDynamic’s Director of Intellectual Property knew of applications that resulted in the patents-in-suit and that AngioDynamics intentionally copied Bard’s CT radiographic marker was sufficient evidence to support a jury verdict of willfulness.

Printed Matter and Validity

Citing AstraZeneca LP v. Apotex, Inc., the CAFC noted courts have long recognized that certain “printed matter” falls outside the scope of patentable subject matter. The CAFC also noted that “[t]oday, printed matter encompasses any information claimed for its communicative content, and the doctrine prohibits patenting such printed matter unless it is ‘functionally related’ to its ‘substrate,’ which encompasses the structural elements of the claimed invention.” The CAFC explained that the existence of a functional relationship is determined by considering whether the printed matter “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to create a new functionality in a claimed device or to cause a specific action in a claimed process.”

The CAFC disagreed with Bard that the claimed printed matter, i.e. markers “identifying” or “confirming” that the implanted access port is “suitable” either “for flowing fluid at a rate of at least 1 milliliter per second through the access port” or “for accommodating a pressure within the cavity of at least 35 psi,” provided new functionality to the port because it makes the port “self-identifying.”  The CAFC stated that “[a] conclusion that mere identification of a device’s own functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine would eviscerate our established case law that ‘simply adding new instructions to a known product’ does not create a functional relationship.” Thus, the CAFC held that the content of the information conveyed by the claimed markers, i.e. that the claimed access ports are suitable for injection at the claimed pressure and flow rate, was printed matter that was not entitled to patentable weight.

Subject Matter Eligibility

The CAFC held that “a claim may be found patent ineligible under § 101 on the grounds that it is directed solely to non-functional printed matter and the claim contains no additional inventive concept.” Noting that the claims recite an assembly, system, or method for identifying a vascular access port as power injectable using multiple means for conveying the device’s functionality, including, specifically, a radiographic marker, the CAFC explained that the claimed advance was not solely on the content of the information conveyed, but also on the means by which that information is conveyed.

The CAFC also noted that even if the prior art asserted by AngioDynamics demonstrated that it would have been obvious to combine radiographic marking with the other claim elements, the evidence did not establish that radiographic marking was routine and conventional under Alice step two. Thus, the CAFC concluded that the claims were not patent ineligible under § 101 because the claims were “not solely directed to printed matter.”

The CAFC concluded by stating that “[b]ecause there remained triable issues of fact as to the infringement and validity of the asserted claims, the district court erred in not permitting Bard to fully present its case at trial.”  Thus, the CAFC reversed-in-part the district court’s judgment of invalidity with respect to ineligibility under Section 101, vacated-in-part the court’s judgment of invalidity as to all other grounds, vacated the judgment of non-infringement and no willful infringement, and remanded the case for further proceedings consistent with the opinion.



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Join the Discussion

8 comments so far.

  • [Avatar for Anon]
    November 24, 2020 01:35 pm

    On another thread, a passing byline reads:

    “The single biggest problem in communication is the illusion that it has taken place.”

    — George Bernard Shaw

    MaxDrei, and his false politeness FEEDS this type of illusion.

  • [Avatar for Anon]
    November 23, 2020 06:30 pm

    To push the conversation a bit more, let’s use MaxDrei’s “blue squash ball” to explore some nuance and see if he ‘dare’ participate…

    One MUST be able to know that utility is involved. The example of the blue squash ball necessarily invokes extrinsic ‘information’ to obtain utility.

    Quite contrary to another’s supposition that ‘in the mind’ is not implicated because of the blue squash ball merely ‘uses’ the brain’s autonomous functioning, would a “blue feather” do?

    After all, the SAME “autonomous functioning” exists whether or not the claimed item is a ball or a feather.

  • [Avatar for Anon]
    November 22, 2020 12:30 pm

    Elsewhere. MaxDrei has posted, “anon, you will not be surprised to read, in my reply, that I am in such thrall to the EPC and the EPO approach to “the presentation of information” that I find it impossible to engage with your writings.

    Over three threads then on three different blogs, ALL that MaxDrei deigns to do is throw his feces at the wall to see what sticks, and then – rudely – ‘finds it impossible to engage.’

    It would be immensely MORE helpful if MaxDrei could ever muster up the courage TO engage.

    Timidity in the sheep’s coat of ‘politeness’ is like being lukewarm, and only deserving of being spat from one’s mouth, is like salt, which has lost its use and is only good to be thrown away, is like a lamp, this (even if) lit, is then covered with a bushel, and casts no light.

  • [Avatar for Anon]
    November 20, 2020 02:25 pm

    So MaxDrei, to your ‘marker as such,’ would ANY marker do? Or do you ACTUALLY require (to garner the effect that you want to proscribe) some other ACTION (i.e., a method claim perhaps) OUTSIDE of the marker as such?

    To draw a parallel, traffic lights ONLY work if the non-intrinsic meanings are permitted. Otherwise, you have a signal that cannot connotate anything, and would fail to have utility.

  • [Avatar for B]
    November 19, 2020 05:56 pm

    From the slip opinion: “There is no evidence in the
    record that such a step was routinely conducted in the prior

    Reyna is officially a horses rear end. Evidence? He changes his position on the issue of evidence every decision.

    However, I’ll use this case to my upcoming advantage

  • [Avatar for MaxDrei]
    November 19, 2020 03:38 am

    Good question, anon. What they “mean” is that patients are less likely to suffer injury (from an exploding port under their skin) during CT procedures.

  • [Avatar for Anon]
    November 17, 2020 06:29 pm

    What does a marker as such mean?

  • [Avatar for MaxDrei]
    November 16, 2020 04:57 pm

    I read that the Decision states:

    “Thus, the CAFC held that the content of the information conveyed by the claimed markers, i.e. that the claimed access ports are suitable for injection at the claimed pressure and flow rate, was printed matter that was not entitled to patentable weight.”

    and I wonder, am I to understand that as a statement that the claimed markers, as such, are entitled to patentable weight?

    Or, to put it another way, is the Fed Ct at pains to draw a distinction between i) the markers as such and ii) the information which those markers convey? In a Doctrine called the “printed matter” doctrine, that strikes me as a somewhat futile exercise. So what is flawed, the Doctrine or the distinction?