Opinion ID: 4585172
Heading Depth: 2
Heading Rank: 3

Heading: Printed Matter and Invalidity

Text: We first clarify procedural aspects of the district court’s judgment before addressing the merits of validity. In its final order, the district court granted both summary judgment and JMOL that the patents were invalid and patent ineligible, without specifying the statutory grounds for invalidity. J.A. 1–4. At the time the motions were granted, however, AngioDynamics had not yet presented its invalidity case at trial and Bard had not had the opportunity to defend the validity of its asserted claims. The district court’s JMOL of invalidity was thus procedurally improper because Rule 50 provides that JMOL against a party is only appropriate once the party “has been fully heard on an issue.” FED. R. CIV. P. 50. For that reason, we consider the merits of the district court’s invalidity judgment only as to the grounds on which AngioDynamics moved for summary judgment, and only to the extent we can reasonably read the district court’s decision as bearing on those grounds. In addressing the merits of those grounds, we consider the entirety of the evidence presented during summary judgment, not merely the facts presented at trial. Here, AngioDynamics moved for summary judgment of invalidity based on subject matter ineligibility, anticipation, and non-enablement. Because nothing in the district court’s decision references or discusses enablement, we review the court’s validity judgment only as to eligibility and anticipation, both of which implicate the printed matter doctrine. We conclude that although the asserted claims contain printed matter that is not functionally related to the remaining elements of the claims, each claim as a whole is patent eligible because none are solely directed to the printed matter. We also conclude that when we assign no patentable weight to the claimed printed matter, material disputes of fact remain as to whether other elements of the claim are novel over the prior art. Case: 19-1756 Document: 72 Page: 14 Filed: 11/10/2020 14 C R BARD INC. v. ANGIODYNAMICS, INC.
This court and its predecessor have long recognized that certain “printed matter” falls outside the scope of patentable subject matter under U.S. patent law. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010) (“This court has generally found printed matter to fall outside the scope of § 101.”); In re Chatfield, 545 F.2d 152, 157 (CCPA 1976) (“Some inventions, however meritorious, do not constitute patentable subject matter, e.g., printed 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. See Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1032 (Fed. Cir. 2018); In re Distefano, 808 F.3d 845, 849 (Fed. Cir. 2015). 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. Praxair, 890 F.3d at 1032; DiStefano, 808 F.3d at 848–49. 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. Thus, we held in In re Marco Guldenaar Holding B.V., that the markings on dice had no functional relationship to the dice themselves because the markings did not cause the dice to become a “manufacture with new functionality.” 911 F.3d 1157, 1161 (Fed. Cir. 2018). We distinguished the dice markings Case: 19-1756 Document: 72 Page: 15 Filed: 11/10/2020 C R BARD INC. v. ANGIODYNAMICS, INC. 15 from the digits printed on a circular band in Gulack 3— where the digits exploited the band’s endless nature and made it useful for performing mathematical operations— and from the volumetric indicia on the side of a measuring cup in Miller 4—where the indicia made the cup useful for measuring partial recipes. Id. Based on analogous reasoning, we held in Praxair that there was a functional relationship between a step of recommending discontinuation of treatment and a step of actually discontinuing treatment because the claim required that the second step be “based on” the first. 890 F.3d at 1035. In contrast, where the discontinuation step was absent from other claims of the same patent, which merely required physicians to “evaluate” the information, we found no functional relationship between the information in the recommendation and the other steps of the claim. Id. at 1033–35. Here, the parties agree that the asserted claims include printed matter. Each claim requires one or more markers “identifying” or “confirming” that the implanted access port is “suitable” either “for flowing fluid at a rate of at least 1 milliliter per second through the access port” or “for accommodating a pressure within the cavity of at least 35 psi,” or both. These elements are directed to the content of the information conveyed. The parties disagree, however, over whether this printed matter is functionally related to the power injectable port, as recited in all the asserted claims, or to the step of performing a power injection, as recited in the method claims. Bard contends that the information conveyed by the markers provides new functionality to the port because it makes the port “self-identifying.” We disagree. A conclusion that mere identification of a device’s own 3 In re Gulack, 703 F.2d 1381, 1382–83 (Fed. Cir. 1983). 4 In re Miller, 418 F.2d 1392, 1393 (CCPA 1969). Case: 19-1756 Document: 72 Page: 16 Filed: 11/10/2020 16 C R BARD INC. v. ANGIODYNAMICS, INC. functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine would eviscerate our established case law that “simply adding new instructions to a known product” does not create a functional relationship. AstraZeneca, 633 F.3d at 1065 (citing In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). 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, 992 (CCPA 1935); In re Johns, 70 F.2d 913, 915 (CCPA 1934); In re Bruce, 56 F.2d 673, 674 (CCPA 1932). Bard also contends that the printed matter is functionally related to the power injection step of the method claims because the medical provider performs the power injection “based on” the identification of the port’s functionality. But there is no language in the claims suggesting such a causal relationship. Bard did not advocate for that construction before the district court, and we see no persuasive basis for reading that limitation into the claims. 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. We next consider whether, in light of the claimed printed matter, the district court properly concluded that the asserted claims were invalid as ineligible or anticipated.
To determine whether claimed subject matter is patent eligible, we apply the two-step framework set forth in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014). First, at step one, we “determine whether the claims at issue are directed to a patent-ineligible concept,” such as an abstract idea. Id. at 218. To determine if the claim’s Case: 19-1756 Document: 72 Page: 17 Filed: 11/10/2020 C R BARD INC. v. ANGIODYNAMICS, INC. 17 character as a whole is directed to excluded subject matter, we “look at the focus of the claimed advance over the prior art.” Chamberlain Grp., Inc. v. Techtronic Indus. Co., 935 F.3d 1341, 1346 (Fed. Cir. 2019) (quoting Affinity Labs of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016)). 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. Alice, 573 U.S. at 221 (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72, 80 (2012)). “The ‘inventive concept’ step requires us to look with more specificity at what the claim elements add, in order to determine whether they identify an ‘inventive concept’ in the application of the ineligible subject matter to which the claim is directed.” Chamberlain, 935 F.3d at 1348 (quoting Affinity Labs, 838 F.3d at 1258). 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. See Praxair, 890 F.3d at 1032 (citing King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010), and In re HuaiHung Kao, 639 F.3d 1057, 1072–74 (Fed. Cir. 2011)). 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. Bard suggests that the answer is no. In support, Bard cites to our decisions in Miller and King Pharmaceuticals, where we declined to hold that claims covering printed matter were patent ineligible under § 101 and instead Case: 19-1756 Document: 72 Page: 18 Filed: 11/10/2020 18 C R BARD INC. v. ANGIODYNAMICS, INC. evaluated whether the printed matter elements were entitled to patentable weight for purposes of §§ 102 and 103. But in neither case 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. Rather, in Miller, we recognized that “printed matter by itself is not patentable subject matter, because [it is] non-statutory,” 5 and in King Pharmaceuticals, 6 we determined that the case was not the right vehicle for a § 101 analysis because the claim was plainly anticipated once the printed matter was set aside. Indeed, eighty years ago, our predecessor court held that “where the printed matter, irrespective of the material upon which it is printed, is the sole feature of alleged novelty, it does not come within the purview of the statute, as it is merely an abstract idea, and, as such, not patentable.” McKee, 75 F.2d at 992. This is consistent with the post-Alice decisions in which we have recognized that the mere conveyance of information that does not improve the functioning of the claimed technology is not patent-eligible subject matter under § 101. See, e.g., Two-Way Media Ltd. v. Comcast Cable Commc’ns, LLC, 874 F.3d 1329, 1338 (Fed. Cir. 2017) (concluding that claims directed to the sending and receiving of information were unpatentable as abstract where the steps did not lead to any “improvement in the functioning of the system”); Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016) (holding that claims directed to “a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions” are directed to an abstract idea); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350 (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 5 Miller, 418 F.2d at 1396. 6 King Pharms., 616 F.3d at 1278. Case: 19-1756 Document: 72 Page: 19 Filed: 11/10/2020 C R BARD INC. v. ANGIODYNAMICS, INC. 19 matter under section 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. With that understanding, we turn to the claims at issue here. The asserted claims recite an assembly, system, or method for identifying a vascular access port as power injectable using multiple means for conveying the device’s functionality, including, specifically, a radiographic marker. When each claim is read as a whole, 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. In particular, the claimed invention is described in the patents as satisfying 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. See ’417 patent col. 1 l. 7–col. 3 l. 4. In concluding that the claims could not be directed to the claimed means for identifying functionality, the district court accepted AngioDynamics’s assertion that all the claimed forms of identification, including radiographic marking, were routine and conventional in the art, and thus could not constitute the patentable focus of the claims. In defense of that position, AngioDynamics relies on Bard’s admission that the use of radiographically identifiable markings on implantable medical devices was known in the prior art, and points to evidence of such use in the prior art, including one vascular port with an x-ray tag that identified the port’s flow rate. Appellee’s Br. 48–49; J.A. 17958–62. But even if we were to conclude that the sole focus of the claimed advance was the printed matter, 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 Case: 19-1756 Document: 72 Page: 20 Filed: 11/10/2020 20 C R BARD INC. v. ANGIODYNAMICS, INC. claimed, was not an inventive concept. BASCOM Global Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1347 (Fed. Cir. 2016). 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. In concluding that the method claims were patent ineligible, the district court further relied on its conclusion that the method claims contained no more than a recitation of the standards of medical care required after the FDA warned doctors about power injection through vascular access ports. 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. 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.
As explained in our discussion of the printed matter doctrine, when evaluating the novelty and non-obviousness of claims, we must assign no patentable weight to the nonfunctional printed matter in the claims, which in this case is the information that the claimed access ports are suitable for injection at the claimed pressure and flow rate. Here, Bard presented largely undisputed evidence that certain prior art ports, and the use of those ports, satisfied most of the remaining elements of the asserted claims, including power injectability and the presence of external identifiers. However, there remained a factual dispute over whether any of the prior art access ports contained a “radiographic marker” or “radiographic feature” as Case: 19-1756 Document: 72 Page: 21 Filed: 11/10/2020 C R BARD INC. v. ANGIODYNAMICS, INC. 21 required by the asserted claims. Although AngioDynamics points to certain features of two prior art ports, the ATP and Port-a-Cath, that may be detectable via x-ray, Bard presented contrary evidence that these features were not radiographically discernible and could not be used to distinguish or identify the device or its functionality. Appellee’s Br. 34–35; J.A. 16217, 17945. This conflicting evidence created a genuine dispute of material fact as to the novelty of the asserted claims. Thus, the district court erred to the extent it granted summary judgment of invalidity based on anticipation under § 102.