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A Matter of Style: No Need to Select “Primary” Reference in Obviousness Challenge

The US Court of Appeals for the Federal Circuit affirmed an obviousness decision by the Patent Trial & Appeal Board, explaining that nothing requires a petitioner to identify a prior art reference as a “primary reference” in an obviousness challenge. Schwendimann v. Neenah, Inc., Case Nos. 22-1333; -1334; -1427; -1432 (Fed. Cir. Oct. 6, 2023) (Prost, Clevenger, Cunningham, JJ.)

Jodi Schwendimann filed lawsuits accusing Neenah of infringing several patents related to transfer sheets and methods for transferring images onto dark fabrics. Neenah filed several petitions for inter partes review (IPR) challenging various claims based on obviousness. The Board instituted the IPR challenges.

Schwendimann’s patents addressed a method for ensuring that dark images could be seen when transferred onto dark fabrics. Multilayer image transfer sheets were known in the prior art, teaching a two-step process to first apply a light background onto dark fabric and then apply the dark image on top. Schwendimann’s claims described a single-step solution, incorporating a white background, possibly of titanium dioxide, into the image transfer sheet so that a white background and dark image could be applied simultaneously onto a dark fabric.

All of the IPR petitions cited Kronzer as a prior art reference. Kronzer described multilayered image transfer sheets with varying configurations, although it lacked white pigment in a layer to transfer an image onto dark fabric. Another prior art reference, Oez, taught the use of a white pigment, such as titanium dioxide, in multilayered image transfer sheets. Schwendimann did not dispute that Kronzer and Oez taught or suggested all limitations recited in the challenged claims. Instead, she argued that there was no motivation for a skilled artisan to combine the references or to expect that such combination would yield a reasonable expectation of success. The Board considered and addressed each argument, relying on Neenah and Schwendimann’s experts’ testimony and the complementary and compatible nature of the references. The Board found the challenged claims obvious over Kronzer in view of Oez. Schwendimann appealed.

Schwendimann argued that substantial evidence did not support the Board’s findings that a skilled artisan would have been motivated to combine Kronzer and Oez and would have had a reasonable expectation of success in making the proposed combination. The Federal Circuit explained that substantial evidence means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion” and considered these two arguments together.

The Federal Circuit found that Schwendimann failed to show that the Board’s findings were not supported by “substantial evidence.” Like the Board, the Federal Circuit used both expert witnesses’ testimonies to explain that the references shared a common goal of improving image transfer characteristics. The Court found that Schwendimann’s arguments that Oez taught away from the proposed combination failed because Oez’s disclosure did not discourage a skilled artisan from using white pigment identified in the challenged patents or lead the skilled artisan in a direction divergent from the path taken in the challenged patents. Her argument that adding titanium dioxide into Kronzer’s transfer sheets could [...]

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No Need To Be Explicit: Implicit Finding of Expectation of Success Is Sufficient

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability decision, finding that a combination of prior art references only requires an implicit indication of a reasonable expectation of success. Elekta Ltd. v. Zap Surgical Systems, Case No. 21-1985 (Fed. Cir. Sept. 21, 2023) (Reyna, Stoll, Stark JJ.)

Elekta owns a patent directed to a “method and apparatus for treatment by ionizing radiation.” The claimed invention uses a radiation source such as a linear accelerator (linac) mounted on concentric rings to deliver a beam of ionizing radiation to a target area on the patient. Zap challenged the patent as obvious in an inter partes review (IPR) proceeding. In its Final Written Decision, the Board agreed, concluding that a skilled artisan would have been motivated to combine the asserted prior art references. Elekta appealed.

Elekta raised three arguments on appeal:

  1. The Board’s findings on motivation to combine were not supported by substantial evidence.
  2. The Board failed to make any findings (explicit or implicit) on a reasonable expectation of success.
  3. Even if the Board made such findings, they were not supported by substantial evidence.

The Federal Circuit first considered the issue of motivation to combine the prior art references disclosing radiation imagery with references disclosing radiation therapy, noting that the obviousness determination does not always require the prior art to expressly state a motivation for every obviousness combination. Elekta had challenged the asserted combination based on a physical impracticality in combining the art due to the weight of the linac. The Board, however, disagreed largely because of the level of skill in the art in addition to its definition of the relevant field as one that “includes the engineering design of sturdy mechanical apparatuses capable of rotationally manipulating heavy devices.” The Court found that the Board’s finding of motivation to combine was supported by substantial evidence, including the prosecution history, the prior art teaching and the expert testimony of record.

The Federal Circuit next considered Elekta’s argument that the Board erred by failing to articulate findings on reasonable expectation of success. The Court explained that “an obviousness determination requires finding that a person of ordinary skill in the art would have had a reasonable expectation of success,” referring to “the likelihood of success in combining references to meet the limitations of the claimed invention.” The Court concluded, however, that unlike the motivation to combine determination, which must be an explicit analysis under KSR, a finding of reasonable expectation of success may be implicit. The Court acknowledged that this could be seen as being in tension with its review of Board determinations under the Administrative Procedure Act but concluded that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including . . . those [regarding] a motivation to combine.”

Finally, the Federal Circuit addressed Elekta’s argument that, even if the Board made an implicit finding on reasonable expectation of [...]

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Absent Nexus Secondary Considerations Come in Second

Addressing the nexus between a secondary consideration and the claimed invention in assessing obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board finding of nonobviousness because the Board erred in its nexus analysis regarding secondary considerations. Yita LLC v. MacNeil IP LLC, Case Nos. 22-1373; -1374 (Fed. Cir. June 6, 2023) (Taranto, Chen, Stoll, JJ.)

Yita petitioned for inter partes review (IPR) of all claims of two patents. The patents share a common specification and cover vehicle floor trays that are theraformed from a polymer sheet of substantially uniform thickness. These trays (illustrated below) were designed to closely conform to the walls of the vehicle foot well so that the trays would stay in place once installed.

The Board found that the claims of one of the patents were not obvious even though an artisan would have been motivated to combine the prior art asserted (which disclosed the “close conformance” limitation) and would have had a reasonable expectation of success because the evidence of secondary considerations was overpowering and included a nexus between the evidence of success and the patented invention. The Board also found that the claims of the other patent were not obvious because the “1/8 inch limitation” regarding the thickness of the foot well was not disclosed in the prior art. The Board declined to consider Yita’s argument, which was raised for the first time in its reply brief. Yita appealed.

Yita argued that the Board committed a legal error in its analysis of the secondary consideration evidence for the first patent and abused its discretion by not considering the argument Yita raised in its reply brief regarding the other patent.

On the secondary considerations issue, the Federal Circuit explained that the Board erred in finding a nexus between the secondary consideration evidence of success and the claimed invention because the Board exclusively related to a feature that was well-known in the prior art (i.e., the close conformance between the tray and the vehicle floor). The Court explained that where the prior art teaches a well-known feature and an artisan would have been motivated to combine such prior art with an expectation of success, any secondary consideration that is exclusively related to the well-known feature will not rescue the claim from obviousness. The Court noted that while secondary considerations can be linked to an individual element of the claimed invention or to an inventive combination of elements, here the Board relied on secondary consideration evidence that was related entirely to the already well-known close conformance of the tray and vehicle floor.

The Federal Circuit next addressed Yita’s argument that the Board should have considered an argument raised in Yita’s reply brief regarding the 1/8-inch limitation. Yita failed to raise the argument that it would have been obvious to modify a prior art reference to arrive at the “1/8 inch limitation” [...]

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Breaking Up Is Hard to Do: Validity Upheld Based on Expert Separation Testimony

The US Court of Appeals for the Federal Circuit affirmed a district court decision finding that two patents covering enantiomerically pure compositions of the psoriasis drug Otezla® (apremilast) were valid and one patent covering a dosage titration schedule was invalid as obvious. Amgen Inc. v. Sandoz Inc. Case No. 22-1147 (Fed. Cir. Apr. 19, 2023) (Lourie, Cunningham, Stark, JJ.)

Amgen markets apremilast, a phosphodiesterase-4 inhibitor that is used for treating psoriasis and related conditions, under the brand name Otezla®. Amgen has three patents covering Otezla®. Two of the patents are directed to orally administered pharmaceutical compositions of enantiomerically pure apremilast (composition patents), and one of the patents covers a dosage titration schedule for enantiomerically pure apremilast that ranges from a starting dose of 10 mg to a dose of 60 mg by the sixth day (dosage patent). Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of apremilast. Amgen filed suit against Sandoz for infringement of its three patents covering Otezla®.

Sandoz asserted that the composition patents were invalid based on prior art that had an example (Example 12) that described a 50%:50% racemic mixture of apremilast but did not disclose the purified apremilast (+) enantiomer recited in the claims. The prior art did state that apremilast could be isolated from this racemic mixture using chiral chromatography, a well-known technique. The district court rejected Sandoz’s argument, finding that there was insufficient evidence to conclude that a skilled artisan would have had reason to believe that the desirable properties of Example 12 derived in whole or in part from the apremilast enantiomer (i.e., the (+) enantiomer). The district court also concluded that Sandoz had not demonstrated that a skilled artisan would have had a reasonable expectation of success in resolving Example 12 into its individual enantiomeric components. Furthermore, the district court looked to objective indicia of non-obviousness, finding that apremilast unexpectedly provided substantial improvement over previously known phosphodiesterase inhibitors in terms of both efficacy and tolerability, and a nexus existed between the unexpected potency and the asserted claims.

Sandoz also argued that the dosage patent was invalid based on prior art that taught various dosage schedules and amounts for apremilast. The district court found that it would have been within the ability of a skilled artisan to titrate apremilast for a patient presenting with psoriasis and that doing so would have been a routine aspect of treating psoriasis with a drug (such as apremilast) that was known in the art to require dose titration to ameliorate side effects. The district court therefore found that the dosage patent was invalid. Sandoz appealed with respect to the composition patents, and Amgen appealed with respect to the dosage patent.

The Federal Circuit affirmed the district court’s decision with respect to the composition patents, finding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify apremilast’s (+) enantiomer from the racemic mixture disclosed in Example [...]

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Obvious to Try Requires Reasonable Expectation of Success Tethered to Claimed Invention

Addressing obviousness in the context of method of treatment claims using particular drug dosages, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) final written decision holding that Teva failed to prove obviousness because it failed to show a reasonable expectation of success. Teva Pharms., LLC v. Corcept Therapeutics, Inc., Case No. 21-1360 (Fed. Cir. Dec. 7, 2021) (Moore, C.J.)

Corcept filed a New Drug Application (NDA) for Korlym, a 300 mg mifepristone tablet administered to certain patients with Cushing’s syndrome. The US Food and Drug Administration (FDA) approved Corcept’s application but required a drug-drug interaction clinical trial to determine drug safety when co-administered with strong CYP3A inhibitors such as ketoconazole (Lee memorandum). Corcept conducted the drug-drug interaction study and received a patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor based on the data from the Lee memorandum.

Teva sought post-grant review of the patent after Corcept asserted it against Teva in district court. Teva argued that the patent would have been obvious in view of Korlym’s label and the Lee memorandum and submitted a supporting expert declaration. The Board held that Teva failed to prove that a skilled artisan would have had a reasonable expectation of success for safe co-administration of more than 300 mg of mifepristone with a strong CYP3A inhibitor, and thus failed to prove that the patent was obvious. Teva appealed, arguing that the Board erroneously required precise predictability rather than reasonable expectation of success in achieving the claimed invention, and that the Board did not apply Federal Circuit prior art range precedents.

The Federal Circuit affirmed the Board’s decision. Turning first to reasonable expectation of success, the Court explained that the analysis must be tied to the scope of the claimed invention. Because the patent required safe administration of a specific amount of mifepristone, the Board did not err in requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. Applying this correct standard, the Court found that the evidence supported that a skilled artisan would have had no expectation as to whether co-administering dosages of mifepristone above the 300 mg/day threshold set forth in the Korlym label would be successful. The Federal Circuit also agreed with the Board that Teva’s expert testimony supported a finding of no expectation of success in achieving the claimed invention based on inconsistent testimony before and after institution.

Turning next to the applicability of Federal Circuit prior art range precedents, the Federal Circuit found that Teva had failed to prove that the general working conditions disclosed in the prior art encompassed the claimed invention. Substantial evidence supported the Board’s finding that there was no overlap in ranges because the prior art (Korlym label and industry publications) capped the range of co-administration dosages at 300 mg/day. The Court also noted that Teva’s reliance on mifepristone monotherapy dosages to create an overlap in the claimed ranges failed because the patent claims [...]

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Federal Circuit Makes Clear: Prior Failures in the Art May Demonstrate Non-Obviousness

Addressing the issue of obviousness of a patent directed toward a method of killing antibiotic-resistant bacteria using only visible light with no photosensitizer, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s (PTAB) decision, finding no obviousness where the asserted prior art did not disclose a successful method that did not use a photosensitizer. University of Strathclyde v. Clear-Vu Lighting, LLC, Case No. 20-2243 (Fed. Cir. Nov. 4, 2021) (Stoll, J.) The Court held that the PTAB erroneously found a reasonable expectation of success where “[t]he only support for such a finding [was] pure conjecture coupled with hindsight reliance on the teachings in the [asserted] patent.”

Gram-positive bacteria, such as Methicillin-resistant Staphylococcus aureus (MRSA), are known to negatively affect health but effective methods of killing (or inactivating) such bacteria have been elusive. Photoinactivation is a way to kill antibiotic-resistant bacteria, and previous methods involved applying a photosensitizing agent to the infection and then activating the agent using light. Through experimentation, scientists at the University of Strathclyde discovered that application of visible (blue) light of wavelengths in the range of 400 – 420 nm was effective at inactivating bacteria such as MRSA without using a photosensitizing agent. The challenged patent claimed this method of using a photosensitizer for inactivating MRSA and other Gram-positive bacteria.

After Clear-Vu Lighting petitioned for inter partes review, the PTAB found the patent invalid as obvious in view of prior art disclosing methods of photoactivation using visible light. The university appealed.

The Federal Circuit reversed, finding that the prior art did not disclose all claim elements and there was no reasonable expectation of success in reaching the claimed invention by combining the prior art.

The Federal Circuit first addressed the PTAB finding that the prior art disclosed all claim limitations, finding that neither of the asserted prior art references taught or suggested “inactivation” of the bacteria without using a photosensitizer—as required by the claims. The Court noted that it “fail[ed] to see why a skilled artisan would opt to entirely omit a photosensitizer when combining [the] references,” finding it “particularly relevant” that one of the references actually “disclosed such a photosensitizer-free embodiment and was wholly unsuccessful in achieving inactivation.”

The PTAB also found that, based on a prior art teaching that “blue light may” inactivate “other bacterial cells that produce porphyrins,” a skilled artisan would have expected that MRSA could be inactivated by blue light without a photosensitizer due to the presence of porphyrins. In defense of the PTAB’s findings, Clear-Vu argued that support for the reasonable expectation of success could be found in the challenged patent itself. Citing its 2012 decision in Otsuka Pharm. v. Sandoz, the Federal Circuit harshly criticized this position, reiterating that the inventor’s own path to the invention is not the proper lens through which to find obviousness; “that is hindsight.”

The Federal Circuit explained that “not only is there a complete lack of evidence in the record that any bacteria were inactivated after exposure [...]

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