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It’s Highlighted and Verified: Reversal of PTAB Non-Obviousness Decision

In a relatively unusual outcome, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board (Board) decision finding non-obviousness in an inter partes review (IPR). Becton, Dickinson, and Co. v. Baxter Corp. Englewood, Case No. 20-1937 (Fed. Cir. May 28, 2021) (Dyk, J.)

Becton petitioned the Board for IPR of Baxter’s pre-America Invents Act (AIA) patent, directed to a system for preparing patient-specific doses and a method for telepharmacy. The Board decided that the patent claims were not shown to be invalid as obvious, but also found that Baxter’s secondary considerations evidence was “weak.” Becton appealed based on two contested limitations: a verification limitation and a highlighting limitation. The Federal Circuit reversed the Board, concluding that the challenged claims were obvious and explained that weak evidence of secondary considerations could not overcome the strong showing of obviousness.

First, the Federal Circuit decided that the Board erred in finding that a prior art reference that taught a remote pharmacist may verify a dose preparation did not render obvious a claimed method where a remote pharmacist must verify. The reference made clear that a non-pharmacist could not further process work without the verification step. Baxter’s own expert witness conceded that, in accordance with the teachings of the prior art, a non-pharmacist would be disciplined for continuing to process dose preparation without authorization. The Court concluded there was no significant difference between the teaching in the prior art reference and Baxter’s verification requirement.

Second, the Federal Circuit decided that the Board erred in finding that the “highlighting” limitation as it relates to a set of drug preparation steps on a computer was non-obvious. In what it characterized as a “close case,” the Board decided that a prior art reference’s teachings highlighting patient characteristics when dispensing repackaged medication did not make obvious highlighting, in a drug formulation context, prompts for additional information. Citing KSR v. Teleflex, the Court explained that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” The reference taught highlighting in terms of various inputs and information delivered. Becton’s expert testified that one of ordinary skill would understand from the reference that other information, such as prescription order information, could be displayed on the user interface. Baxter’s expert did not contradict Becton’s expert. Because “a person of ordinary skill is also a person of ordinary creativity, not an automaton,” the Board erred in using that one reference as the only source for what one of ordinary skill would consider.

Lastly, Baxter unsuccessfully argued that under pre-AIA 35 U.S.C. § 102(e)(2), one of the patent references was ineligible as prior art. Sec. 102(e)(2) provides that a prior art reference may be a “patent granted” on another’s application filed in the United States before the invention by the applicant. Baxter argued that since the claims of the reference were cancelled after a 2018 IPR, the reference no longer qualified as a “patent granted” [...]

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Doesn’t Scan: Skin Cancer Detection Device Just Combination of Familiar Elements

The US Court of Appeals for the Federal Circuit overturned a finding of non-obviousness of certain claims relating to a device for the detection of skin cancer, finding that the Patent Trial & Appeal Board erred in applying the law of obviousness. Canfield Scientific, Inc. v. Melanoscan, LLC, Case No. 19-1927 (Fed. Cir. Feb. 18, 2021) (Newman, J.)

Canfield Scientific filed a petition for inter partes review challenging the validity of claims of a Melanoscan patent as obvious in view of several prior art references. After the Board upheld the validity of the challenged claims, Canfield appealed.

The device disclosed in the patent is “an enclosure fitted with cameras and lights arranged in a manner that allows for imaging of [all or part] of non-occluded body surfaces in order to detect health and cosmetic disease.” The two challenged independent claims both required:

  • An enclosure configured to receive a person or portion thereof, wherein the enclosure defines a specified imaging position for placing the person or portion thereof within the enclosure
  • A plurality of imaging devices, wherein the plurality of imaging devices are vertically spaced relative to each other, a plurality of the imaging devices are located on opposite sides of the centerline of the specified imaging position
  • A plurality of light sources spaced relative to each other and peripheral to the plurality of imaging devices.

Canfield listed four references in support of its obviousness argument—Voigt, Hurley, Crampton and Daanen. Voigt disclosed an enclosure containing cameras and lights for analyzing and measuring images on the skin of a patient. Voigt did not disclose imaging devices (cameras) vertically and laterally spaced and on opposite sides of the center line. Instead, Voigt taught positioning the subject along the wall and positioning the cameras in a single direction.

Hurley, Crampton and Daanen each taught placement of a subject in the center of the enclosure, with cameras arranged vertically, laterally and on opposite sides of the centerline.

Canfield argued that the combined teachings of the prior art would have reasonably suggested the subject matter of the challenged claims. The Board found this argument unpersuasive, concluding that “Voigt’s rear wall would have blocked the view of the two rear-facing cameras, and Voigt’s horizontally adjustable sliders would have partially blocked the views of the remaining cameras.” Thus a person of skill in the art would not have been motivated to combine “the unmodified Voigt system with Hurley’s arrangement of imaging devices.” The Board did not discuss Crampton or Daanen.

The Federal Circuit disagreed with the Board’s conclusion and stated that the references showed the subject being imaged placed against a wall in Voigt, and centrally placed within the framework in Hurley, Crampton and Daanen. The references showed the cameras laterally and vertically spaced to each other about a center line. Citing the seminal Supreme Court KSR obviousness decision, the Federal Circuit noted that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable [...]

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