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C. R. Bard v. Angiodynamics – It’s a Labelled Injection Port, not a Label

The recent decision in C. R. Bard, Inc. v. Angiodynamics Inc., Appeal nos. 2019-1756 and 2019-1934 (Fed. Cir., November 10, 2020) is an example of a bad doctrine, patent eligibility, gone rogue. The panel’s ultimate decision that the claimed invention was not patent ineligible as an abstract idea should have required one paragraph of this opinion, not four pages (!). This opinion conflates the printed matter doctrine with the Mayo/Alice test in a manner that invokes a  legal chimera comprising more shock value than logic. Here is claim 1 of Bard’s U.S. Pat. No. 8,475,417:

“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 power injection of a fluid]; 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 [attained during power injection of a fluid], 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 power injection of a fluid].

Previous power injection ports had not always been suitable for “power injection” of fluids under high flow rates and high pressures. Predictably, the panel found that the “identifiable features” were not entitled to weight in the patentability analysis under the printed matter doctrine: “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.”

Of course, Bard was not trying to patent the “printed matter”the detectable marker—but simply was reciting it in the claim. Later in the opinion, the panel comes close to agreeing with Bard:

‘’In particular, the claimed invention is described in the patents as satisfying a specific need for easy vascular access during CT imagining, and it is the radiographic marker in the claimed invention that makes the claimed port particularly useful for that purpose because the marker allows the implanted device to be readily and reliably identified via x-ray, as used during CT imaging.”

This sounds like an example of a functional relationship of a marker to its ‘substrate.’ The panel is conceding that the marker alters the utility of the device.  But I want to get back to the Mayo/Alice analysis in the opinion. Step one of the Mayo/Alice analysis is summarized as if we were in a divorce court hearing: “To determine if the claims character as a whole is directed to excluded subject matter, we ‘look at the focus of the claimed advance over the prior art’.” I have not read the cited precedent, but I have never felt the need to evaluate a claims “character” and there is no requirement that a patent-eligible invention must advance the art. Instead of simply saying that there is a lot more to the claim than the printed material, the panel declares that it must resolve a case of first impression:

“Notably, since the Supreme Court articulated [the Mayo/Alice test], this court has not directly addressed whether a patent claim as a whole can be deemed patent ineligible on the grounds that it is directed to printed matter at step one and contains no additional inventive concept at step two.”

This is not even the question before the panel, but it continues to elucidate the manifestly apparent state of the law.  The panel cites Digitech Image Techs. LLC v. Elecs. For Imaging, Inc., 758 F.3d 1341 (Fed. Cir. 2014): “Data in its ethereal, non-physical form is simply information that does not fall under any of the categories of eligible subject matter.” The panel goes on:

“We therefore hold that a claim may not be found patent eligible under s. 101 on the grounds that it is directed solely to non-functional printed matter and the claim contains no additional inventive concept.”

This sentence would have been fine if it ended with “printed matter” but in a sort of legal time warp it jumps into step 2 of the Mayo/Alice test(!) Now the panel continues its walk through the entire Mayo/Alice test for patent eligibility. In other words, is claim 1 directed to patent ineligible subject matter and, if so, do the remaining claim elements demonstrate the requisite inventive concept that pulls the invention back from the brink of abstraction? The panel holds that the claimed port may meet the requirements of step two:

“Even if we were to conclude that the sole focus of the claimed advance was the printed matter, 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 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…We therefore hold that the asserted claims are not patent ineligible because the claims in their entireties are not solely directed to printed material.”

That sounds like a conclusion based on step one of Mayo/Alice, not step two. The panel came to the correct conclusion, but so would any first year law student who noticed that s. 101 permits patents for machines or manufactures, such as a vascular access port.


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