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).
Slip Op.
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.
Slip Op.
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.
MM would <3 this case. Or would've.
He would have botched it up and I would have a field day with his mistakes.
As I always did.
LOL
On first reading, it seems that the eligibility or lack of it comes down to whether the presence (versus absence) of radiographically readable, meaningfully distinctive or ordered letters, symbols or other markers of any kind on subcutaneous access ports is routine or conventional, or instead provides something functionally more (such as indicating which of several such ports is the correct one to access in a given situation, rather than leaving a technician to blindly guess), but that any claimed requirement for some specific combination of letters (e.g. ‘CT’) would be directed solely to nonfunctional printed matter and lack patentable weight. If I understand this correctly, the court below found the mere presence of printed matter to be, in itself, nonfunctional and thus directed to ineligible subject matter without adequately addressing step 2 of the Alice analysis.
For those who are interested, here is claim 1 of the subject patent. It uses the term “identifiable feature” for the radiographically perceivable markings.
1. 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.
Software is printed matter.
But of course, it can’t be correct that all novelty and utility in software is beyond the patent system’s proper reach. But of course, it can’t be correct that written expression and all information useful to persons can be subject to patents.
But there is an easy, intuitive way to distinguish between those poles.
Your statement appears to imply that software MAY only be ”written expression.” Just not so.
Software is, of course, merely a design choice of Wares in the computing arts.
That particular choice has multiple aspects, and it is the multiple aspects that may be covered under the multiply different IP laws.
Re: “..our case law has typically applied the [“printed matter”] 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.” Noting the older CCPA cases cited here, would it not have been more accurate to say that this was true in more recent CAFC cases that were not following those earlier cases that were treating printed matter as a separate unpatentable subject matter defense?
The practical significance of this C R Bard Inc. v. AngioDynamics, Inc. decision [if followed by other CAFC panels] is of course that this defense can now be raised in a preliminary 101 motion, avoiding a multi-million dollar jury trial.
Maybe a couple points of clarification to Prof. Crouch’s post:
“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”
The CAFC held that the district court’s grant of JMOL on invalidity was procedurally improper because neither party had yet presented evidence regarding validity at trial. Therefore, the CAFC evaluated the district court’s judgment based on the summary judgment arguments and evidence, not whether a directed verdict was proper. See p. 13.
“On remand there will be a new trial on infringement and validity, apparently including aspects of Alice Step 2.”
I read the CAFC’s opinion as holding as a matter of law the claims are eligible under Alice Step 2. See p. 20: “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.”
Also, the 101 part of the district court’s judgment was “reversed” whereas the part of the judgment on “all other grounds” of invalidity was “vacated” and remanded.
Thanks P. I’ll go back and re-read.
This is confusing to me. Is the court doing something tricky by saying “not patent ineligible” rather than “patent eligible.” And, the reasoning appears divorced from our patent eligibility doctrine — “because the claims in their entireties are not solely directed to printed matter.”
I think that is is only as tricky as to the same degree that the courts will use the double negative of “not invalid.”
Basically, for the arguments made (and not including arguments not made), eligibility is present. You won’t get the ‘absolute affirmative’ for the same reason courts don’t do that for validity determinations.
Yes, very confusing. The opinion specifically points out that the JMOL was procedurally improper, but then (as I indicate above), the opinion could be read as saying Bard was entitled to JMOL on eligibility. In light of the court’s explicit statement that it was reviewing the summary judgment arguments and evidence, this sentence is ambiguous:
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.
Does this mean that AngioDynamics’s evidence does not entitle it to judgment as a matter of law (the summary judgment standard)? or does this mean that, as a matter of law, AngioDynamics’s evidence is not sufficient to meet Alice step two (more like the JMOL standard)?
For what it’s worth, as noted in the opinion, there were cross-motions for summary judgment on the eligibility issue. Also, unlike for anticipation, the court’s opinion does not explicitly say there are any remaining fact issues regarding eligibility.
Claim 8 is a method claim.
They sniff ever closer…information consumed by persons cannot be eligible subject matter…
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