Federal Circuit Review - Issue 282

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282-1 Federal Circuit Opines on Printed Matter Doctrine and Reverses District Court Decision Holding Medical Device Patent Invalid and Noninfringed

The United States Court of Appeals for the Federal Circuit recently reversed a district court finding of invalidity and noninfringement of medical device maker C.R. Bard’s (Bard) patent claims, reviving a nearly 70-million-dollar lawsuit. C R Bard v. Angiodynamics, Inc., Nos. 2019-1756, 2019-1934, 2020 U.S. App. LEXIS 35389 (Fed. Cir. Nov. 10, 2020) (Before Reyna, Schall, and Stoll, Circuit Judges) (Opinion for the Court, Reyna, Circuit Judge).

Bard developed the first FDA approved vascular access port labeled for power injection, a procedure in which a fluid is injected into a patient at a high flow rate and high volume, and filed several patent applications which eventually issued as U.S. Patent Nos. 8,475,417 (the ’417 patent), 8,545,460 (the ’460 patent), and 8,805,478 (the ’478 patent). Each of the claims of these patents require the presence of a radiographic marker identifying the claimed port as capable of a power injection. Bard sued medical device competitor AngioDynamics, Inc. (AngioDynamics) for patent infringement after AngioDynamics received FDA approval to label their vascular access port product for power injection, and eventually included a radiographic marker to its product.

Device Claim 1 of the ’417 patent is representative of the system and assembly type claims Bard asserts:

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, 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, 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.

Method Claim 8 of the ’478 patent is representative of the method type of claims Bard asserts:

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

Bard filed suit against AngioDynamics in the District of Delaware, asserting that AngioDynamics’s product infringed certain claims of the ’417 patent, the ’460 patent, and the ’478 patent. The parties proceeded to jury trial, and after Bard presented its case on infringement, willfulness, and damages, AngioDynamics moved for summary judgment and judgment as a matter of law of non-infringement and no willfulness. The court granted AngioDynamics’s motions and Bard appealed the judgments of non-infringement, no willfulness, and invalidity, including ineligibility under § 101.

On appeal, the Federal Circuit, reconsidered the district court’s judgment on infringement and invalidity. With respect to infringement, the district court had granted judgment as a matter of law of non-infringement for each of three separate grounds – (1) that Bard’s expert failed to apply the court’s claim construction for certain terms of the claims; (2) that Bard had not shown that the accused product met flow rate requirements of the asserted claims; and (3) that Bard’s evidence had not shown that a single entity performed all the claim steps of the asserted method claims.

During cross-examination, Bard’s expert testified that he believed that there was an intent requirement implied in the court’s claim construction of the access port “structured for power injection.” However, the Federal Circuit reasoned that the expert had not relied on the intent aspect of his claim interpretation in reaching his infringement opinion. Further, even had he incorrectly included an intent element in reaching his infringement opinion, nothing in the record suggested that this caused him to disregard the requirements of the asserted claims under the correct claim construction. The Federal Circuit additionally found that Bard was entitled to rely on AngioDynamics’s representation to the public and the FDA that their product was suitable for power injection as required by the asserted claims and that there was sufficient circumstantial evidence to support AngioDynamics’s induced infringement of the method claims.

With respect to willfulness, the district court found no willfulness based on a conclusion that Bard failed to show that AngioDyanmics infringed. Alternatively, the district court held that Bard failed to meet its burden because AngioDynamics obtained written opinions regarding invalidity of the asserted claims. The Federal Circuit reconsidered based on a review of the evidence Bard introduced at trial, including that AngioDynamics was aware of the patent applications that ultimately issued as the patents-in-suit prior to their issuance and that AngioDynamics intentionally copied Bard’s radiographic marker based on market demand.

The Federal Circuit also reviewed the district court findings of invalidity and patent ineligibility. Both invalidity and patent ineligibility arguments presented by AngioDynamics involved the printed matter doctrine, which states that claim elements of communicative content are not given patentable weight unless the printed matter is functionally related to the claimed invention. However, the Federal Circuit found that even though the claims included printed matter, the claims were not solely directed to printed matter and were patent eligible under § 101.

With respect to anticipation, the Federal Circuit found that conflicting evidence presented by Bard was sufficient to create a genuine dispute of material fact as to the novelty of the asserted claims such that the district court erred in granting summary judgment of invalidity based on anticipation under § 102.

Accordingly, the Federal Circuit reversed the district court’s judgment of invalidity under § 101, vacated the judgment of invalidity on all other grounds, vacated the judgment of non-infringement and no willful infringement, and remanded the case back for further proceedings.

An expert witness’s reliance on an incorrect claim construction in an infringement opinion that still addresses all the requirements of the asserted claims may still be relied upon in determining infringement. Claims including printed matter may be patent eligible if the claims include an inventive concept beyond the printed matter.

282-2 Federal Circuit Concludes PTAB Applied Improper Standard When Determining Whether a Reference was Analogous Art

The United States Court of Appeals for the Federal Circuit recently vacated and remanded the Patent Trial and Appeal Board’s finding that Donner Technology failed to prove unpatentability of a patent owned by Pro Stage Gear due to failing to establish the cited reference was analogous art. See Donner Tech., LLC v. Pro Stage Gear, LLC, No. 2020-1104, 2020 U.S. App. LEXIS 35295 (Fed. Cir. Nov. 9, 2020) (Before Probst, Chief Judge, Dyk and Hughes, Circuit Judges) (Opinion for the Court, Probst, Chief Judge).

Pro Stage Gear, LLC (Pro Stage) is the owner of U.S. Patent 6,459,023 (the ’023 patent) directed to an improved guitar effects pedalboard that provides easy positioning and changing out of various guitar effects and a confined, secure area beneath the guitar effect mounting surface for cable routing and placement. Donner Technology, LLC (Donner) petitioned for inter partes review of the ’023 patent alleging that the ’023 patent was obvious in view of U.S. Patent No. 3,504,311 to Mullen (Mullen).

Mullen is directed to a support structure for mounting electrical relays. The support structure further provides a space for receiving wires to ultimately connect the electrical relays in control circuits. Donner asserted that Mullen is analogous to the guitar effects pedalboard in that the structure of Mullen includes “surfaces for mounting relays, cable connection openings, and area for routing cables.” See Appellant’s Br. 14-17. Accordingly, Donner asserted that in view of Mullen, the ’023 is obvious, and thus, unpatentable. The Board disagreed, finding that Donner failed to establish Mullen is analogous art. Subsequently, Donner appealed.

On appeal, the Federal Circuit ultimately concluded that the Board applied the wrong standard when determining whether Mullen was analogous art, and thus, the Federal Circuit vacated and remanded the Board’s decision.

The Federal Circuit first explained that there are two separate tests used when defining the scope of analogous prior art: “(1) whether the art is from the same field of endeavor, regardless of the problem addressed; and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference is reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). The parties agreed that the ’023 patent and Mullen are not within the same field of the inventor’s endeavor.

With regards to the second test, the Federal Circuit noted that the Board erred when stating Donner did not assert any argument or evidence to indicate a person inventing such pedalboard as disclosed in the ’023 patent would have considered the relay technology disclosed in Mullen, because Donner did in fact submit expert testimony supporting such an argument. Additionally, the Federal Circuit explained the Board “failed to properly identify and compare the purposes or problems to which Mullen and the ’023 patent relate.” Instead, the Federal Circuit explained the Board improperly intertwined the characterization of the problem that the ’023 patent attempted to resolve with the field of endeavor, the field of endeavor being pedal boards for mounting guitar effects, such that references outside such field of endeavor were essentially excluded from consideration. The Federal Circuit noted the Board identified multiple differences between the ’023 patent and Mullen. However, the Federal Circuit clarified that a reference can still be analogous art “even if there are significant differences between the two references.” See In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1380 (Fed. Cir. 2007).

The Federal Circuit went on to indicate that there will often be significant differences between a patent and a reference from a different field of endeavor, but that alone, does not mean the reference is not reasonably pertinent to one or more problems the disclosed technology attempts to solve.

Lastly, the Federal Circuit explained the proper inquiry when determining whether a reference is analogous art under the reasonably pertinent test is not whether a person having ordinary skill in the art would have understood every detail of the reference but instead whether such person having ordinary skill in the art “would reasonably have consulted” the reference in solving the relevant problem or problems. Heidelberger Druckmaschinen AG v. Hantscho Com. Prods., Inc., 21 F.3d 1068, 1071 (Fed. Cir. 1994).

Accordingly, the Federal Circuit vacated the Board’s decision and remanded the case for resolution of the relevant factual issues using the proper standard for determining whether a reference is analogous art.

The relevant inquiry when determining if a reference is reasonably pertinent to a particular problem an inventor is attempting to resolve, and thus whether the reference is analogous art to the patent at issue, is whether the person having ordinary skill in the art would have reasonably consulted the reference when trying to solve the pertinent problem.

282-3 Federal Circuit Finds a Published Book was Properly Considered Prior Art by the Patent Trial and Appeal Board

The Federal Circuit recently affirmed two inter partes review decisions by the Patent Trial and Appeal Board (the Board) involving U.S. Patent No. 9,083,997 (the ’997 patent) owned by Vidstream LLC (Vidstream) finding that the ’997 patent was unpatentable in view of a book published less than one year prior to Vidstream filing the application resulting in the ’997 patent. See Vidstream LLC v. Twitter, Inc., Nos. 2019-1734, 2019-1735, 2020 U.S. App. LEXIS 37201 (Fed. Cir. Nov. 25, 2020) (Before Newman, O’Malley, and Taranto, Circuit Judges) (Opinion for the Court, Newman, Circuit Judge).

On May 9, 2012, Vidstream filed a patent application directed to methods and systems for recording and publishing content on social networking websites and other websites which ultimately issued as the ’997 patent. Twitter, Inc. (Twitter) filed two petitions for inter partes review challenging Claims 1–35 of the ’997 patent citing a book authored by Anselm Bradford and Paul Haine (the Bradford reference) as the primary reference for both petitions. See Anselm Bradford & Paul Haine, HTML5 Mastery: Semantics, Standards, and Styling (2011). Along with both petitions, Twitter filed copies of several pages of the Bradford reference and explained their relevance to the ’997 claims.

During inter partes review, Vidstream argued that the Bradford reference was not prior art because the Bradford reference was published after the priority date of the ’997 patent. In support of its argument, Vidstream referenced a page submitted by Twitter showing that the Bradford reference was published in 2015, after the priority date of the ’997 patent. In reply, Twitter filed additional documents to support its position that the Bradford reference was prior art, including a copy of the Bradford reference that was obtained from the Library of Congress showing the date of first publication as November 8, 2011, evidence of an established publisher of the Bradford reference in 2011, a listing of the Bradford reference offered for sale on Amazon web pages in 2011, and the book’s existence in the MARC records dated August 25, 2011. The Board found the additional evidence indicated that the Bradford reference was published prior to the filing of the ’997 patent and was therefore prior art. Finding the Bradford reference to be prior art, the Board found Claims 1–35 of the ’997 patent unpatentable over Bradford in combination with the other cited art.

On appeal, Vidstream challenged the Board’s acceptance of the additional documents filed by Twitter during inter partes review arguing that, per the PTO’s Trial Guide for inter partes review, Twitter may not submit new evidence or argument in a reply that it could have presented earlier. See Trial Practice Guide Update, United States Patent and Trademark Office 14–15 (Aug. 2018). Twitter responded that the additional documents it filed with its replies were appropriate in view of Vidstream’s challenge of the Bradford reference’s publication date. The Federal Circuit agreed with Twitter finding that the Board had not erred in allowing Twitter to submit additional evidence and that the Board had properly concluded that the Bradford reference is prior art. Accordingly, the Federal Circuit affirmed the Board’s unpatentability decision.

The Patent Trial and Appeal Board can allow a petitioner to present evidence that a reference is prior art after the filing of the petition, if a patent owner later challenges whether that reference is prior art.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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