Federal Circuit Affirms USPTO’s Rejection of Application for Diagnostic Testing Patent

Two patent applicants struck out at the U.S. Court of Appeals for the Federal Circuit  (CAFC) Thursday when the court affirmed a Patent Trial and Appeal Board (PTAB) decision upholding a U.S. Patent and Trademark Office (USPTO) examiner’s rejection of their application for a diagnostic testing patent.

Patent application No. 12/925,221 is directed to “collect[ing] a sample of a volatile material (e.g., breath or urine) produced by a living entity (e.g., person or animal) and then analyz[ing] the sample using a mass spectrometer to create a digital health record with information such as the living entity’s age or weight” in order to diagnose certain conditions. The examiner rejected all of the pending claims as either anticipated, obvious, indefinite and lacking adequate written description, or directed to patent ineligible subject matter.

On appeal, the CAFC first rejected the applicants’ (Haines) argument that the Board erroneously affirmed the examiner’s reliance on a prior art reference with an effective date after the ‘221 application was made. “37 C.F.R. § 1.131 does not apply if the rejection is ‘based upon a statutory bar,’ such as when the asserted reference is a published patent application, as Cranley is here,” wrote the court. Since the earliest priority date of Haines’s application was October 29, 2009, and Cranley was published on January 17, 2002,  “Cranley was properly determined to be prior art.”

On the merits, Haines challenged all of the Board’s conclusions, but the CAFC only focused on the anticipation of one of the claims because it said it was dispositive of the appeal.

Haines argued the Board was wrong in affirming the examiner’s reliance on prior art reference Han to conclude that Cranley “implicitly discloses” a limitation of one of the claims because anticipation findings must be based on a single reference; thus, relying on Han as an additional reference was error.

But the CAFC said Han was not used as an additional reference. “Rather, as explained by the Board, the examiner ‘utilize[d] Han only as evidence to explain’ why Cranley’s disclosure of a mass spectrometer implicitly discloses ‘obtain[ing] mass spectral channel signals (m/z),’” wrote the CAFC.

Haines also argued that its claimed limitations regarding sample collection “teach away” from Cranley, but the court said that teaching away is irrelevant to an anticipation analysis, among other reasons for its disagreement. For instance, Haines noted that Cranley requires its breath sample to “not [be] contaminated” and to be “processed in a quantitative analyzer,” while the ‘221 application’s claims do not contain such requirements, but the CAFC explained “that a reference discloses additional requirements absent from a claim does not detract from the reference’s disclosure of the claimed limitations.”