C R Bard Inc. v. AngioDynamics, Inc. (Fed. Cir. 2020)

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

One of the more intellectually dishonest aspects of current patent eligibility law is that it allows one to ignore certain claim elements when evaluating claims under 35 U.S.C. § 101.  In Mayo v. Prometheus, it was stated that once one has identified a judicial exception to patentability (e.g., a law of nature, natural phenomena, or abstract idea) in a claim, further claim elements that are "well-understood, routine, conventional activity [that] when viewed as a whole, add nothing significant beyond the sum of their parts taken separately" essentially have no patentable weight in the eligibility inquiry.  This is despite the Court's acknowledgement that Diamond v. Diehr stood for the notion that claims "must be considered as a whole."[1]

Further, the Supreme Court never dug into the details of whether or how this holding should be squared with prior art analyses under §§ 102 and 103.  The Mayo opinion asserted that "in evaluating the significance of additional steps, the § 101 patent-eligibility inquiry and, say, the § 102 novelty inquiry might sometimes overlap."  But the nature of this overlap was not explored.  Instead, in both Mayo and the subsequent Alice v. CLS Bank decision, the "well-understood, routine, conventional" test appears to allow judicial notice that certain claim features are so generic that one need not provide any factual evidence that this is the case.  The Federal Circuit has attempted to rectify this matter in Berkheimer v. HP, holding that -- in at least some situations -- the § 101 analysis involves underlying factual matters of whether elements are "well-understood, routine, conventional."

And yet, the division of claims into "judicial exceptions" and "additional elements" can be tricky, as can knowing when one should ignore certain elements.  And the Federal Circuit has not provided clear guidance.  It is common to view a claim at a high level (and therefore ignore at least some of its elements) to declare the claim to be directed to a judicial exception.  In some cases, claims have been found to be directed to an exception because what they recite assumed to be known, and in other cases additional elements have been found to incorporate further exceptions that were subsequently ignored.

The problem with this element-oriented, reductionist approach is that it obscures the actual invention being considered.  There was wisdom in Diehr's instruction to study the whole claim because inventions consisting of nothing but judicial exceptions and well-understood, routine, conventional additional elements are some of the most important to our current and future economy (e.g., cryptography, machine learning, quantum computing, diagnostic methods, analysis of genetic sequences).  The value is in the combination of these features, not the features in isolation.  Ignoring any claim element under § 101, without a very good reason,[2] does violence to the invention.

As we will see, the printed matter doctrine is another avenue in which claim elements can be discounted.

Bard launched an infringement action against AngioDynamics in the District of Delaware.  At issue were Bard's U.S. Patent Nos. 8,475,417, 8,545,460, and 8,805,478.  As a representative example, claim 1, of the '417 patent recites:

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.

The invention is directed to "vascular access ports, which are devices implanted underneath a patient's skin that allow medical providers to inject fluid into the patient's veins on a regular basis without needing to start an intravenous line each time."  Notably, "the FDA cautioned medical providers in 2004 and 2005 that they should not use vascular access ports for power injection unless the ports were specifically and identifiably labeled for such use."  Accordingly, Bard developed such identifying labels for its ports, which the Court described as follows:

The primary identifying feature Bard developed was a radiographic marker in the form of the letters "CT" etched in titanium foil on the device.  This marker could be detected during an x-ray scan such as the "scout scan" typically performed at the start of a CT procedure.  Other identifiers incorporated into the device included a triangular shape and small bumps that were palpable through the skin.

In any event, the District Court judge asked a magistrate to help determine whether the identifiable features of the claims should be given patentable weight in view of the printed matter doctrine.  The magistrate "determined that these limitations were not entitled to patentable weight because they were directed to the content of information that was not functionally or structurally related to the claimed ports."  The judge went with this conclusion.

At the end of the trial, AngioDynamics filed a JMOL motion, and the judge asked the parties whether this printed matter issue was ripe for decision.  While the parties did not come to an agreement, the judge terminated the trial and granted the JMOL.  Among other rulings, the judge found the claims "invalid because they were directed to printed matter as ineligible subject matter and were not inventive."

Regarding this § 101 issue, the Federal Circuit began its analysis by acknowledging that printed matter has long been held to fall outside the scope of patentable subject matter.  In particular, "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.  Thus, the main concern is 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."

As examples, the Court has previously decided that markings on dice have no functional relationship with the dice themselves.  On the other hand, digits printed on a circular band exploited the band's endless nature and made it useful for performing mathematical operations, and thus there was a functional relationship between the two.  Likewise, volumetric indicia on a measuring cup made the cup useful for measuring partial recipes.

In this case, the parties stipulated that the claimed identifiable features constitute printed matter, but disagreed over whether these features are functionally related to the port.  Bard contended that "the information conveyed by the markers provides new functionality to the port because it makes the port self-identifying."  The Court did not buy into this point, as "mere identification of a device's own functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine" would eviscerate the doctrine.

Turning to the subject matter eligibility issue, the Court admitted that, since Alice, it had 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."  But it found reason to do so here, as such a position is consistent with its prior holdings that "the mere conveyance of information that does not improve the functioning of the claimed technology is not patent-eligible subject matter under § 101.  Notably, the Court pointed to the claims found ineligible in Two-Way Media Ltd. v. Comcast Cable Commc'ns, LLC, Elec. Power Grp., LLC v. Alstom S.A., and Digitech Image Techs., LLC v. Elecs. for Imaging, Inc. as examples that stand for the principle that the processing of information does not improve the functioning on a computer.

Applying these notions to Bard's claims, the Court found that "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."  Particularly, the claims address "a specific need for easy vascular access during CT imaging, 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.  With respect to the Alice framework, the Court concluded that there was insufficient evidence that "the use of a radiographic marker, in the ordered combination of elements claimed, was not an inventive concept."  Notably, "[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."  Thus, in accordance with Berkheimer, not all obvious elements would also be routine and conventional.

Therefore, the asserted claims are patent-eligible because they are not solely directed to printed matter.

One of the subtle points of this case is that the Federal Circuit seems to be equating printed matter with the notion of an abstract idea under step one of Alice.  Therefore, if a claim includes printed matter, it would have to also include additional elements that amount to significantly more to be eligible.  One way of establishing that this is the case is if the printed matter, in combination with the additional elements, provides functionality that the additional elements on their own do not provide.

But taking this a step further, printed matter doctrine provides more opportunities to ignore claim elements.  While that did not happen in this case, it would not be surprising for this holding to be expanded in a way that provides yet one more avenue for to do so.  It is conceivable that some courts could apply the doctrine to user interface claims in an attempt to establish that at least some of the displayed information therein is not related to the functionality of the computing system, thus rendering those claims ineligible.

C R Bard Inc. v. AngioDynamics, Inc. (Fed. Cir. 2020)
Panel: Circuit Judges Reyna, Schall, and Stoll
Opinion by Circuit Judge Reyna

[1] The Court attempted to synthesize this apparent contradiction between Mayo and Diehr by stating that "[b]ecause the approach we made explicit in Mayo considers all claim elements, both individually and in combination, it is consistent with the general rule that patent claims must be considered as a whole."  But in practice, the consideration of claim elements in combination was and is given short shrift. 

[2] Elements that are redundant with other elements and preambles reciting intended use are examples in which parts of claims can be disregarded.

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McDonnell Boehnen Hulbert & Berghoff LLP

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