by Dennis Crouch
C R Bard Inc. v. AngioDynamics, Inc., No. 19-1756 (Fed. Cir. 2020) (Opinion by Judge Reyna, joined by Judges Schall and Stoll).
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Important: The court in this case particularly holds 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.”
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Question: How does the printed-matter-doctrine apply to letters that can only be read using an X-ray?
Answer: It is still printed matter; the limitations are given no patentable weight; and might render the whole claim ineligible.
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The invention in this case was prompted by a 2005 FDA labelling requirement for IV ports capable of handling fluids “power injected” directly into a patient’s veins. (Most IV ports are designed for low-pressure gravity flow). Bard’s IV ports were apparently already designed for use in power-injection, but not fully labelled.
More than Skin Deep: The problem with labelling is that the ports are under the skin, and so are not susceptible to a written label. Bard’s solution: “a radiographic marker in the form of the letters ‘CT’ etched in titanium foil on the device.” The radiomarker would then be seen on a pre-treatment “scout scan.” The products also include shapes palpable through the skin, although that feature is not required in the claims:
providing an access port including … a radiographic feature indicating that the access port is suitable for flowing fluid at a rate of at least 1 milliliter per second through the access port …
identifying the access port as being suitable for flowing fluid at a rate of at least 1 milliliter per second through the access port via the image of the radiographic feature of the access port …
Claim 8 of US8805478. In essence, Bard wants to be the only company that sells ports with the CT radiographic marker.
In 2015, Bard sued AngioDynamics for infringement and the case went to trial before a jury. But, the jury never got to deliberate. After Bard presented its case-in-chief the court terminated the trial and granted JMOL (directed verdict) for the defendant — finding particularly: no infringement, no willful infringement, and that the claims are invalid as directed ineligible subject matter (printed matter) and also not inventive. The district court explained:
Fundamentally, after listening to the evidence presented to the jury and considering the evidence for the previous motions for summary judgment, the Court finds this patent is about labeling, not invention and not technology.
C R Bard Inc. v. AngioDynamics Inc., 382 F. Supp. 3d 332 (D. Del. 2019).
Printed Matter Doctrine: Under Praxair and other cases, the Federal Circuit has expanded the printed matter doctrine to “encompass any information claimed for its communicative content.” Printed matter can be patent eligible it is functional rather than merely communicating about the invention.
Here, the court found that the marker is on the port as a label precisely for the purpose of informing others about the functionality of the product.
Indeed, as early as the 1930s, our predecessor court recognized that the mere marking of products, such as meat and wooden boards, with information concerning the product, does not create a functional relationship between the printed information and the substrate. See In re McKee, 75 F.2d 991 (CCPA 1935); In re Johns, 70 F.2d 913 (CCPA 1934); In re Bruce, 56 F.2d 673 (CCPA 1932).
Printed Matter and Eligibility: So we have claimed printed matter what next?: One answer is that portion of the claim is “not entitled to patentable weight.” The second question though is weather the entire claim fails under Alice?
Although the underlying rationale of the printed matter doctrine lies in the requirements of subject matter eligibility under § 101, our case law has typically applied the doctrine to hold that specific limitations of a claim are not entitled to patentable weight for purposes of novelty under § 102 and non-obviousness under § 103.
Although the court has traditionally not applied eligibility-doctrine to printed-matter, the court here notes that prior precedent “did we foreclose the possibility that an entire claim could be found patent ineligible when the claim as a whole is directed to printed matter.” Slip Op.
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.
Id. On the merits of this case, the court found that Step-Two of Alice (lack of “something more”) was not clear enough for
a directed verdict summary judgment:
AngioDynamics’s 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.
Id. A confusing aspect of the decision is that it identified its judgment on Section 101 as a “reversal”, but really looks more like a vacatur.
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What is the impact of a claim term being “not entitled to patentable weight.” Here, the court narrowly defined the printed matter as “the information that the claimed access ports are suitable for [power] injection.” The court still gave weight to the requirement of a “radiographic marker.” Thus, if you scroll up to the two claim-terms that I copied, it appears that the first term (“providing … a radiographic feature”) is given patentable weight while the second term (acting on information provided by the feature) is not. The district court gave neither patentable weight. On appeal the court also vacated on anticipation.
On remand there will be a new trial on infringement and validity, apparently including aspects of Alice Step 2.