Invention Directed Solely to Printed Matter Held Not Patent Eligible

Intellectual Property Law

C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard), and AngioDynamics, Inc., manufactured vascular access ports that were inserted under a patient’s skin to enable medical providers to insert fluid into the patient’s veins without having to initiate a new intravenous line. The Food and Drug Administration (FDA) warned medical providers not to use vascular access ports for power injection unless the ports were labeled for such use.1

Bard sold vascular ports that could be used for power injection, even though they had not been approved for such use by the FDA. Bard then developed detectible information that would dependably indicate the power injection function after the implanting of the port, using a radiographic marker with the letters “CT” etched in titanium foil. Bard included other identifiers that could be felt through the skin, as well as labeling on the packaging of the device. Bard received FDA approval for its power injection device marketed under the brand PowerPort.2

Bard owned U.S. Patent Nos. 8,475,417 (’417 patent), 8,545,460 (’460 patent) and 8,805,478 (’478 patent) directed to a radiographic marker that indicated the port was power injectable. The ’417 and ’460 patents claimed “assemblies” and “systems” for a vascular access port identified as a power injection port. Claim 1 of the ’417 patent recited the following:

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.3

The ’478 patent was directed to methods for carrying out a power injection process that identified a vascular access port approved for power injections and implementing the power injection. Claim 8 recited the following:

8. A method of performing a power injection procedure, comprising:

providing an access port including a cannula-impenetrable housing and 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;

implanting the access port in a subcutaneous pocket formed under a patient’s skin;

taking an image of the implanted access port via imaging technology;

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; and

injecting contrast media fluid through the access port at a rate of at least 1 milliliter per second.4

AngioDynamics received FDA approval to market its own vascular access port for power injection sold under the brand names Smart Port CP, Smart Port LP, Smart Port mini, Xcela, Xcela Plus and BioFlo.5

Bard sued AngioDynamics, alleging AngioDynamics’ access port infringed the ’417, ’460 and ’478 patents. AngioDynamics requested the court to dismiss the complaint because none of the claims of the patents in suit were patent eligible under 35 U.S.C. § 101.6 The district court held that the claims recited printed matter and were directed to patent-ineligible subject matter.7

Bard appealed, and the Federal Circuit reversed and remanded. Specifically, the Federal Circuit held that while the claims included printed matter not functionally connected to the other claim elements, each claim as a whole was patent eligible because it was not solely directed to printed matter. In addition, the court held that after no patentable weight was afforded to the printed matter, issues remained as to whether other elements of the claim were novel and patent eligible.8

The Federal Circuit observed that certain “printed matter” is not considered patent-eligible subject matter:

While historically “printed matter” referred to claim elements that literally encompassed “printed” material, the doctrine has evolved over time to guard against attempts to monopolize the conveyance of information using any medium. . . . 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.9

The court explained some considerations when determining whether a functional relationship exists:

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.10

The parties agreed that the claims contained printed matter, since each claim recited one or more markers “identifying” or “confirming” that the inserted access port was suitable for power injection applications. The parties disputed, however, whether the printed matter was functionally related to the substrate, i.e., the power-injectable port. Bard argued that the information communicated by the markers delivered new functionality because it made the port self-identifying. The court rejected this argument because merely adding new instructions to a known article would not produce a functional relationship.11 According to the court:

Thus, we hold that the content of the information conveyed by the claimed markers—i.e. that the claimed access ports are suitable for injection at the claimed pressure and flow rate—is printed matter not entitled to patentable weight.12

To determine whether claims recite patent-eligible subject matter, the two-step framework set forth in Alice Corp. Pty. Ltd. v. CLS Bank Int’l is employed:

First, at step one, we determine whether the claims at issue are directed to a patent-ineligible concept, such as an abstract idea. . . . To determine if the claim’s character as a whole is directed to excluded subject matter, we look at the focus of the claimed advance over the prior art. . . . If we conclude that the claim is directed to a patent-ineligible subject matter, then at step two, we examine the elements of the claim to determine whether it contains an inventive concept sufficient to transform the claimed ineligible subject matter into a patent-eligible application.13

The court explained that while the printed matter doctrine relates to subject matter eligibility under 35 U.S.C. § 101, the doctrine has characteristically been used to prevent specific claim limitations from being provided patentable weight in connection with anticipation under 35 U.S.C. § 102 and nonobviousness under 35 U.S.C. § 103. The court remarked:

Notably, since the Supreme Court articulated its two-step framework in Alice, 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.14

The court answered this issue by clarifying as follows:

[M]ere 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.15

Here, the court reasoned, when each claim was considered as a whole, the invention was based on not solely the information, but also the means by which the information was transmitted. Specifically, the claimed invention provided simplified vascular access during CT imaging, and the claimed radiographic marker enabled the implanted device to be easily and consistently recognized via X-ray to be used during CT imaging.16

The court also explained that AngioDynamics’ evidence did not demonstrate, according to Alice step two, that the radiographic marker used in the ordered combination of claimed elements was not an inventive concept. According to the court:

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.17

The court rejected the district court’s reasoning that the claims only recited standards of medical care dictated by the FDA. According to the court:

But 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. There is no evidence in the record that such a step was routinely conducted in the prior art.18

Therefore, the Federal Circuit held that the claims were patent eligible under § 101 because the claims when considered as a whole were not solely directed to printed matter and had not been shown to be routine and conventional under Alice step two.19

Takeaways:

Drafting patent application specifications and claims for inventions that include printed matter can be a perilous journey. Descriptions of such inventions preferably need to explain how the printed matter is functionally related to the other claimed features of the invention. If the printed matter is not functionally related to the other claimed features, then the printed matter will not provide any basis for distinguishing the invention from the prior art, and arguably is superfluous.

Since claims are interpreted in view of the patent application specification, the specification, to the extent possible, should describe the functional relationship between any printed matter and other functional features. Thus, the C. R. Bard Inc. v. AngioDynamics, Inc. decision is a warning to patent applicants that some printed matter–related inventions might not be patent eligible or might have additional hurdles to overcome, as opposed to other, more typical inventions.


Irah Donner is a partner in Manatt’s intellectual property practice and is the author of Patent Prosecution: Law, Practice, and Procedure, Eleventh Edition, and Constructing and Deconstructing Patents, Second Edition, both published by Bloomberg Law. Irah was also a software developer and former member of technical staff at Bell Communications Research (Bellcore).


1. Id., 979 F.3d at 1375.

2. Id., 979 F.3d at 1375.

3. Id., 979 F.3d at 1375–76 (quoting U.S. Patent No. 8,475,417, col. 30 l. 51–col. 31 l. 6).

4. Id., 979 F.3d at 1376 (quoting U.S. Patent No. 8,805,478, col. 31 ll. 41–56).

5. Id., 979 F.3d at 1377.

6. Id., 979 F.3d at 1377.

7. Id., 979 F.3d at 1378.

8. Id., 979 F.3d at 1381.

9. Id., 979 F.3d at 1381 (quoting Praxair Distrib. Inc. v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1031–32, 126 U.S.P.Q.2d 1749, 1753 (Fed. Cir. 2018); In re DiStefano, 808 F.3d 845, 848–49, 117 U.S.P.Q.2d 1265, 1267–68 (Fed. Cir. 2015)).

10. Id., 979 F.3d at 1381.

11. Id., 979 F.3d at 1381–82.

12. Id., 979 F.3d at 1382.

13. Id., 979 F.3d at 1382 (quoting Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 221, 110 U.S.P.Q.2d 1976, 1982 (2014); Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 72, 80, 101 U.S.P.Q.2d 1961, 1966, 1968–69 (2012) (quotation marks and citations omitted)).

14. Id., 979 F.3d at 1383.

15. Id., 979 F.3d at 1383.

16. Id., 979 F.3d at 1384.

17. Id., 979 F.3d at 1384.

18. Id., 979 F.3d at 1384.

19. Id., 979 F.3d at 1384.

 

 
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