Printed Matter Challenge to Patent Eligiblity
| December 11, 2020
C R Bard Inc. v. AngioDynamics Inc.
November 10, 2020
Opinion by: Reyna, Schall, and Stoll (November 10, 2020).
Summary:
A vascular access port patent recited “identifiers” that were not given patentable weight under the printed matter doctrine. Printed matter constitutes an abstract idea under Alice step 1. Nevertheless, even though printed matter was not given any patentable weight and the claim was directed to printed matter under Alice step 1, the claims were found eligible under Alice step 2.
Background:
Bard sued AngioDynamics in the District of Delaware for infringing U.S. Patent Nos. 8,475,417, 8,545,460, and 8,805,478. One representative claim is claim 1 of the ‘417 patent:
An assembly for identifying a power injectable vascular access port, comprising:
a vascular access port comprising a body defining a cavity, a septum, and an outlet in communication with the cavity;
a first identifiable feature incorporated into the access port perceivable following subcutaneous implantation of the access port, the first feature identifying the access port as suitable for flowing fluid at a fluid flow rate of at least 1 milliliter per second through the access port;
a second identifiable feature incorporated into the access port perceivable following subcutaneous implantation of the access port, the second feature identifying the access port as suitable for accommodating a pressure within the cavity of at least 35 psi, wherein one of the first and second features is a radiographic marker perceivable via x-ray; and
a third identifiable feature separated from the subcutaneously implanted access port, the third feature confirming that the implanted access port is both suitable for flowing fluid at a rate of at least 1 milliliter per second through the access port and for accommodating a pressure within the cavity of at least 35 psi.
Vascular access ports are implanted underneath a patient’s skin to allow injection of fluid into the patient’s veins on a regular basis without needing to start a new intravenous line every time. Certain procedures, such as computed tomography (CT) imaging, required high pressure and high flow rate injections through such ports. However, traditional vascular access ports were used for low pressure and flow rates, and sometimes ruptured under high pressures and flow rates. FDA approval was eventually required for vascular access ports that were structurally suitable for power injections under high pressures and flow rates. To distinguish between FDA approved power injection ports versus traditional ports, Bard used the claimed radiographic marker (e.g., “CT” etched in titanium foil on the device) on its FDA approved power injection ports that could be detected during an x-ray scan typically performed at the start of a CT procedure. Additional identification mechanisms included small bumps that were palpable through the skin, and labeling on device packaging and items that can be carried by the patient (e.g., keychain, wristband, sticker). AngioDynamics also received FDA approval for its own power injection vascular access ports including a scalloped shaped identifier and a radiographic “CT” marker.
AngioDynamics raised ineligibility under §101 using the printed matter doctrine to nix patentable weight for the claimed identifiers in its motion to dismiss the complaint, its summary judgment motion, and later during the trial on an oral JMOL motion. In advance of the trial, the district court requested a report and recommendation from a magistrate judge regarding whether “radiographic letters” and “visually perceptible information” limitations in the claims were entitled patentable weight under the printed matter doctrine, as part of claim construction. The district court judge adopted the magistrate judge’s recommendations on the printed matter and ultimately granted AngioDynamic’s JMOL motion for ineligiblity.
The Printed Matter Doctrine:
This decision summarized the printed matter doctrine as follows:
- “printed matter” is not patentable subject matter
- the printed matter doctrine prohibits patenting printed matter unless it is “functionally related” to its “substrate,” which includes the structural elements of the claim
- while this doctrine started out with literally “printed” material, it has evolved over time to encompass “conveyance of information using any medium,” and “any information claimed for its communicative content.”
- “In evaluating the existence of a functional relationship, we have 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.”
Here, there is no dispute that the claims include printed matter (markers) “identifying” or “confirming” suitability of the port for high pressure or high flow rate. These markers inform people of the claimed information – suitability for high pressure or high flow rate.
Bard asserted that the markers provided a new functionality for the port to be “self-identifying.” This reasoning was rejected because mere “self-identification” being new functionality “would eviscerate our established case law that ‘simply adding new instructions to a known product’ does not create a functional relationship.” For instance, marking of meat and wooden boards with information concerning the product does not create a functional relationship between the printed information and the substrate.
Bard asserted that the printed matter is functionally related to the power injection step of the method claims because medical providers perform the power injection “based on” the markers. This reasoning was also rejected because the claims did not recite any such causal relationship.
Accordingly, the Federal Circuit held that the markers and the information conveyed by the markers, i.e., that the ports are suitable for power injection, is printed matter not entitled to patentable weight.
Nevertheless, despite the holding about printed matter not given patentable weight, the Federal Circuit still found the claims to be patent eligible under Alice step 2.
Before getting to Alice step 2, the Federal Circuit equates printed matter to an abstract idea, citing to an eighty year old decision “where the printed matter, is the sole feature of alleged novelty, it does not come within the purview of the statute, as it is merely an abstract idea, and, as such, not patentable.” The court further equates this to post-Alice decisions (Two-Way Media, Elec. Pwr Grp, Digitech) recognizing that “the mere conveyance of information that does not improve the functioning of the claimed technology is not patent eligible subject matter. under §101.” “We therefore hold 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.”
However, with regard to Alice step 2’s inventive concept, the court viewed “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” (i.e., via the radiographic marker). Bard admitted that use of radiographically identifiable markings on implantable medical devices was known in the prior art. Nevertheless, “[e]ven if the prior art asserted by AngioDynamics demonstrated that it would have been obvious to combine radiographic marking with the other claim elements, that evidence does not establish that radiographic marking was routine and conventional under Alice step two.” “AngioDynamics’ evidence is not sufficient to establish as a matter of law, at Alice step two, that the use of a radiographic marker, in the ‘ordered combination’ of elements claimed, was not an inventive concept.” Even with regard to the corresponding method claim, “while the FDA directed medical providers to verify a port’s suitability for power injection before using a port for that purpose, it did not require doing so via imaging of a radiographic marker…[t]here is no evidence in the record that such a step was routinely conducted in the prior art.”
Takeaways:
- The printed matter doctrine not only precludes patentable weight for §§102 and 103 inquiries, but also raises abstract idea issues under Alice step 1.
- This case also reminds us of the eligibility hurdles for data processing inventions, with Two-Way Media “concluding that claims directed to the sending and receiving of information were unpatentable as abstract where the steps did not lead to any ‘improvement in the functioning of the system;’” Elec. Pwr Grp “holding that claims directed to ‘a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions’ are directed to an abstract idea;” and Digitech stating that “data in its ethereal, non-physical form is simply information that does not fall under any of the categories of eligible subject matter under section 101.”
- For Alice step 2, this case exemplifies the high bar for establishing “routine and conventional.” Here, the patentee’s admission that radiographic marking on implanted medical devices is known in the prior art was not enough to establish “routine and conventional.” Even prior art that demonstrates the obviousness of combining radiographic marking with the other claim elements was also not enough to establish “routine and conventional.”
- For Alice step 2, this case may exemplify the breadth of what constitutes an inventive concept in “an ordered combination.” The court does not specify exactly what the “ordered combination” was here. Perhaps, the “significantly more” (beyond the abstract idea of the printed matter) could simply be the combination of a radiographic marker and a port.
