November 23, 2020
On November 10, in C. R. Bard, Inc. v. AngioDynamics, Inc., the Federal Circuit clarified that a patent claim may be found patent-ineligible under 35 U.S.C. § 101 on the ground that it is directed to non-functional “printed matter.” The court further explained how the Alice doctrine applies when a claim contains some terms directed to printer matter and some structural terms. This case provides significant guidance under the printed matter doctrine.
The plaintiffs, C. R. Bard, Inc., and Bard Peripheral Vascular, Inc. (collectively, “Bard”), brought a patent infringement action in the U.S. District Court for the District of Delaware against AngioDynamics, Inc., for infringement of Bard’s U.S. Patent Nos. 8,475,417, 8,545,460, and 8,808,478 (“the asserted patents”). The asserted patents are directed to a medical device that uses a radiographic marker to identify to a user that a vascular access port is “power injectable,” meaning that the port may be used for injection of fluids into a vein at claimed flow rates and/or claimed pressures. The radiographic marker may be seen in an X-ray scan at the start of the medical procedure to confirm to the user that the access port is power injectable.
During trial, at the close of Bard’s case-in-chief, AngioDynamics moved for judgment as a matter of law (“JMOL”) of non-infringement based on lack of evidence of direct infringement and a JMOL of no willful infringement based on lack of evidence of willfulness. The district court asked the parties sua sponte whether the issue of patent eligibility and printed matter were also ripe for decision. The district court granted AngioDynamics’ motion for JMOL of non-infringement and no willful infringement, and in the same opinion granted AngioDynamics’ pre-trial motion for summary judgment of invalidity based on patent ineligibility under section 101 and the Supreme Court decision in Alice Corp. v. CLS Bank Int’l and also based on anticipation under 35 U.S.C. § 102, both of which implicated the printed matter doctrine.
On appeal, the Federal Circuit reversed the district court’s JMOL and summary judgment rulings. The Federal Circuit held that there was sufficient evidence to create triable issues of fact regarding direct and indirect infringement and willfulness. The court then discussed the rationale and history of the printed matter doctrine in reversing the summary judgment of invalidity.
The court reviewed precedents of the Federal Circuit and the Court of Customs and Patent Appeals addressing the printed matter doctrine and initially noted that “historically ‘printed matter’ referred to claim elements that literally encompassed ‘printed’ material.” The court then noted that the doctrine “has evolved over time to guard against attempts to monopolize the conveyance of information using any medium,” going on to say, “Today, 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 court explained that in evaluating the existence of a functional relationship, it has considered “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.” In the asserted patents, the court noted that the parties agreed that the asserted claims included printed matter, which the court described as “one or more markers ‘identifying’ or ‘confirming’ that the implanted access port is ‘suitable’ either” for the claimed fluid flow rate or the claimed fluid pressure. In recognizing the claim elements as printed matter, the court emphasized that “These elements are directed to the content of the information conveyed.”
The court then focused on the question of whether the printed matter in the claims is “functionally related to the power injectable port, as recited in all the asserted claims, or to the step of performing a power injection, as recited in the method claims.” The court rejected Bard’s argument that information conveyed by the radiographic markers provides “new functionality” to the port because it makes the port “self-identifying.” The court stated that such a finding would “eviscerate our established case law that ‘simply adding new instructions to a known product’ does not create a functional relationship.”
The court also rejected Bard’s argument that “the printed matter is functionally related to the power injection step of the method claims because the medical provider performs the power injection ‘based on’ the identification of the port’s functionality.” The court noted that Bard did not advocate for such a claim construction and saw no reason to read such a limitation into the claims. Therefore, the court explicitly held “that the content of the information conveyed by the claimed subject matters—i.e. that the claimed access ports are suitable for injection at the claimed pressure and flow rate—is printed matter not entitled to patentable weight.”
The court went on to consider whether patent claims containing one or more elements directed to printed matter not having “patentable weight” can be invalidated as ineligible subject matter under section 101. The court noted that prior case law had evaluated whether printed matter elements were entitled to patentable weight under sections 102 and 103, concluding that prior decisions did not “foreclose the possibility that an entire claim could be found patent ineligible when the claim as a whole is directed to printed matter.” The court noted that post-Alice decisions have recognized that “the mere conveyance of information that does not improve the functioning of the claimed technology is not patent-eligible subject matter under § 101.” The court concluded that in the asserted patents, when “each claim is read as a whole, the focus of the claimed advance is not solely on the content of the information conveyed, but also on the means by which that information is conveyed.” The court further stated that even if the sole focus of the claimed advance was the printed subject matter, the evidence is insufficient to establish as a matter of law, “at Alice step two,” that the use of a radiographic marker in the “ordered combination” of claimed elements was not an inventive concept; that is, the evidence “does not establish that radiographic marking was routine and conventional under Alice step two.” Thus, the court specifically held, “We therefore hold that the asserted claims are not patent ineligible under § 101 because the claims in their entireties are not solely directed to printed matter.”
Regarding Bard’s invalidity argument under section 102, the Federal Circuit held that “when evaluating the novelty and non-obviousness of claims, we must assign no patentable weight to the non-functional printed matter in the claims, which in this case is the information that the claimed access ports are suitable for injection at the claimed pressure and flow rate.” The court held that there remained a factual dispute as to whether the asserted prior art contained the other claim elements that do not claim printed matter, i.e., the claim elements calling for a “radiographic marker” or “radiographic feature.” Thus, the Federal Circuit vacated the finding of invalidity based on section 102, and remanded the case to the district court for further proceedings consistent with the Federal Circuit’s opinion.
This Federal Circuit decision is significant because it (1) establishes that the printed matter doctrine may be a ground for invalidating claims as being patent-ineligible under section 101 and Alice; (2) confirms that in a validity analysis under section 101, claim elements specifying printed matter have no patentable weight unless they are functionally related to other structural elements of the claimed invention; and (3) confirms that even if a patent claim is deemed to be focused solely on printed matter, the claim may be patent-eligible if the “Alice step 2” analysis shows that the “ordered combination of elements” is not routine and ordinary.
For more information on this ruling, please contact Fitch Even partner Karl R. Fink, author of this alert.
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