IP Law Daily, PATENT—Fed. Cir.: PTAB’s obviousness decisions regarding ear molding device to correct misshapen ears largely affirmed, (Jul 22, 2022)

By Robert Margolis, J.D.

Court examines the teachings of prior art, and applies “plain meaning” analysis to claim construction.

The U.S. Court of Appeals for the Federal Circuit has largely affirmed rulings by the Patent Trial and Appeal Board that certain claims in two patents owned by Becon Medical Limited and Henry Stephenson Byrd, M.D., are obvious over prior art, while others are not obvious. TalexMedical had petitioned for inter partes review of several of the claims in the patents. The court agreed with the Board’s construction of several terms, though it found error when the Board adopted the construction proposed by one party and in the court’s estimation, neither parties’ construction was correct (TalexMedical, LLC v. Becon Medical Ltd., July 22, 2022, Lourie, A.).

Ear molding devices. Becon owns two patents that describe “correcting misshaped ears using a molding device.” U.S. Patent Nos. 8,166,942 (the “’943 patent”) and 8,853,277 (the “’277 patent”). The molding device is described as “generally a semi-cylindrical extension from legs (or braces) … and … having rounded edges.”

Inter partes review. Telex petitioned the Board for inter partes review of certain claims in each of the patents, asserting that the challenged claims would have been obvious over a combination of prior art references, which include Dancey, Gault, and Yotsuyanagi. Dancey discloses an acrylic ear splint for non-surgical treatment of cryptopia, which is a congenital ear deformity. Gault discloses an ear splint with a wire core enclosed in a cover. Yotsuyanagi discloses thermoplastic splints conforming to the ear’s outside, also treating cryptopia.

The Board held that claims 1-3 and 9 of the ’942 patent would have been obvious over Dancey and Gault and that claim 1 also would have been obvious over Yotsuyanagi and Gault. It also held that claims 1-2 and 9-10 of the ’277 patent would have been obvious over combinations of Yotsuyanagi and Gault. The Board rejected Talex’s obviousness arguments as to claims 4-7 of the ’942 patent and claim 16 of the ’277 patent.

The Board reached several conclusions relevant to the appeal. First, it declined Becon’s request to construe “mold” and “molding device” to require a reshaping of the ear, and construed “scaphal mold” to mean “mold at the end of one or more braces that is positionable in the scaphal area. The Board also found that Dancey and Yotsuyanagi each independently disclose an ear molding device as recited in the two Becon patents. It then found that Dancey, but not Yotsuyanagi, discloses the limitation of a “semi-cylindrical extension.” It further found that Talex failed to show Dancey’s foot member includes a “broad flat surface.” The Board also construed the “reversibly engage” limitation to mean “to engage a surface on a reverse side facing away from the ear,” and applied this construction to find that Dancey fails to disclose that limitation.

Finally, the Board concluded that Becon failed to establish its entitlement to a nexus between secondary considerations and the asserted claims, or a presumption of a nexus, as its briefing and evidence lacked the necessary specificity to establish either the nexus or presumption.

Talex appeal. Talex argued that three of the Board’s findings were erroneous: (1) that Yotsuyanagi fails to disclose the “semi-cylindrical extension” limitation; (2) that Dancey fails to disclose the “broad flat surface” limitation; and (3) the Board’s construction of the “reversibly engage” language. The court addressed each of these claimed errors.

For the “semi-cylindrical extension” argument, which related to claim 16 of the ’277 patent, the Board found that Talex failed to show that the “scaphal mold” portion of Yotsuyanagi’s device is the portion that includes the claimed extension. The teachings of prior art present a fact question, the Board’s determination of which is reviewed for substantial evidence. The court found that substantial evidence supported the Board’s decision on this issue. While Talex contended that the Board failed to consider an annotated version of a figure in Yotsuyanagi, the court noted that Talex’s annotations were confusing, and Talex did not clear up the confusion when it had the chance before the Board. In any event, the evidence showed that the Board did consider the annotated figure, as it was cited in the Board’s decision. The court thus affirmed the Board’s rejection of Talex’s obviousness claim as to claim 16 of the ’277 patent.

The “broad flat surface” argument related to claim 4 of the ’942 patent, and again the court found that the Board’s construction was supported by substantial evidence. The Board found that Dancey’s foot, the portion that is adjacent to the patient’s head, appears thin rather than broad and curved rather than flat. While the Board did not discuss every piece of evidence that Talex presented purporting to show the contrary, the failure to discuss evidence does not alone establish that the Board failed to consider it, the court noted. The court thus affirmed the rejection of Talex’s obviousness claim as to claim 4 of the ’942 patent.

Finally, Talex contended that the Board’s construction of the “reversibly engage” limitations in claims 5-7 of the ’942 patent as meaning “to engage a surface on a reverse side facing away from the ear” was erroneous. The Board had adopted Becon’s proposed construction, but the court held that neither Becon’s nor Talex’s construction was plausible. The Board’s failure to consider that both constructions could be inconsistent with the evidence was error, the court held. Though it rejected the Becon construction the Board adopted, the court did not simply replace it with Talex’s. Instead, it adopted the following meaning for “reversibly engage”: “interchangeably engage with and disengage from, to stabilize the device.” It vacated the Board’s judgment of no invalidity for claims 5-7 of the ’942 patent and remanded to the Board to apply the correct claim construction.

Becon’s cross-appeal. Becon appealed on three grounds. The Board erred: (1) in construing the “mold” limitation in all of the claims at issue, and also in determining that Dancy and Yotsuyanagi disclosed the “mold limitation”; (2) in weighing Becon’s secondary considerations evidence; and (3) denying its motion to amend to add substitute claims.

As to the “mold” construction, the court held that the Board correctly concluded that the “mold” limitation does not require reshaping. As the court noted, the Board was correct in pointing out that the claims already include functional language, and the specifications describe embodiments in which a mold alone is not sufficient to reshape an ear. Given that the Board’s “mold” construction was correct and the Dancey/Yotsuyanagi argument was based on the premise that the construction was erroneous, the court also rejected Becon’s argument as to the prior art disclosure of the mold limitation, agreeing with the Board that the prior art teaches it.

Becon’s “secondary considerations” argument was similarly non-availing, the court held. Becon asserted that there is a nexus between objective indicia relating to its EarWell product and the challenged claims in the two patents. But the Board had found that Becon failed to establish that the EarWell product is the claimed invention, and the court agreed. While Becon contended that the Board failed to consider evidence it presented, the court found that the Board conducted “a thorough review” of that evidence, including expert declarations and other substantive evidence.

Finally, the Federal Circuit affirmed the denial of Becon’s motion to amend, which was to add substitute claims with a new limitation. The Board found that the proposed new limitation was disclosed in Yotsuyanagi, such that even if amendment were allowed, it would not render the claims patentable. The court agreed with Talex that the Board correctly weighed the evidence regarding Yotsuyanagi’s teachings.

The case is Nos. 2021-2069, 2021-2071, 2021-2109, 2021-2110.

Attorneys: Javier Sobrado (The Brickell IP Group) for TalexMedical, LLC. David Bogdan Cupar (McDonald Hopkins LLC) for Becon Medical Ltd. and Henry Stephenson Byrd, M.D.

Companies: TalexMedical, LLC; Becon Medical Ltd.

Cases: Patent FedCirNews GCNNews