By Colette Ghazarian – Edited by Olga Slobodyanyuk
USPTO Patent Trial and Appeal Board Under No Obligation to Review Evidence Not Originally Presented
The Federal Circuit, in In Re: Thomas Steed, 2014-1458 (Fed. Cir. Oct. 1, 2015), made clear that the United States Patent and Trademark Office’s Patent Trial and Appeal Board “cannot be faulted for not reviewing evidence that was not presented to it or to the [patent] Examiner.” This holding was made in the context of an appeal by Thomas Steed of the rejection of his patent application on the ground of obviousness. During the application process, the patent examiner had rejected Steed’s claims based on a pre-grant publication that anticipated Steed’s invention. Steed appealed to the Board, attempting to “swear back” his invention, whereby Steed would establish that he was in possession of the idea or product before the effective date of the Evans publication. Steed submitted a series of new evidence and documents to the Board on appeal and at the Board hearing. The Board held that the new evidence brought at the hearing should have been presented at the outset of the application process, and therefore should not be considered, and, to the extent any new evidence could be considered by the Board, that information was unintelligible and not self-explanatory. The Court agreed with the Board and held that any proof a patent applicant has of an earlier conception date, should have been presented to the patent examiner in the first instance through a continuation application, and the Board is under no obligation to consider new evidence that was not presented in that manner.
“Substantially Pure” Compound Held Obvious When 50/50 Mixture and Pure Compound Prior Art Exists
In Spectrum Pharmaceuticals, Inc. v. Sandoz, Inc., 2015-1407 (Fed. Cir. Oct. 2, 2015), the Federal Circuit tackled the unusual issue of patent validity, where the patent involves a substantially pure compound, but a 50% mixture and pure compound are both known in the art. Spectrum had developed and patented a pharmaceutical composition of substantially pure levoleucovorin, a compound used to ameliorate the toxic effects of chemotherapy, containing 92% of the active isomer (mixed with another isomer as a carrier). In 2011, Sandoz submitted an Abbreviated New Drug Application (ANDA) for a similar pharmaceutical levoleucovorin product, claiming that it did not infringe on five of Spectrum’s patent claims, and, though stipulating to infringement of two others, argued that Spectrum’s patent was invalid as to those claims. The prior art showed that both a 50/50 mixture of the two isomers and a pure compound were already known. The Court held that, given these existing compounds, Spectrum’s claim that its 92% pure compound was nonobvious, fails. The Court concluded that the available prior art could have enabled one of skill in the art to make and use the substantially pure levoleucovorin compound. The Court of Appeals also affirmed the District Court’s ruling that Sandoz’ product did not infringe on the remaining claims of Spectrum’s patent because the product did not contain enough of the levoleucovorin compound to constitute infringement.
Federal Circuit Expands Patent Enablement Analysis
In In Re: Steve Morsa, 2015-1107 (Fed. Cir. Oct. 19, 2015), the Federal Circuit addressed for the second time the anticipation of claimed inventions by Steve Morsa in a publication entitled Peter Martin Associates Press Release (PMA). The appeal was brought after a finding by the United States Patent and Trademark Office’s Patent Trial and Appeal Board that the anticipating reference (PMA) was enabled. The Board relied on Morsa’s own specification that the system described in his patent “can be implemented by any programmer of ordinary skill” and found that the PMA disclosure combined with what an average-skilled computer programmer would know rendered the reference enabling. The Court, in a 2-1 decision, held that the Board’s enablement analysis was proper. The Court held that the Board did not err in including the patent application specification itself in conducting its enablement analysis. Taking into account the specification, the Court agreed with the Board that it showed an ordinary programmer could implement the invention. This finding, combined with the PMA disclosure would allow an average computer programmer to make the claimed patent herself. Therefore, the Court determined that Morsa’s patents were anticipated. Morsa’s also argued that the Board utilized novel grounds of rejection of his patents, by considering various facts not typically used in enablement analysis. The majority disagreed, contending that the Board’s statements were merely descriptive and not necessary to the Board’s conclusions. Therefore, they were not part of the Board’s enablement analysis.