This past March, as most in the patent community are well aware, the Supreme Court recalibrated 35 U.S.C. § 101 in Mayo Collaborative Services v. Prometheus. The decision held that certain patents of Prometheus Laboratories were directed to non-statutory subject matter. Specifically, the Court found the Prometheus patents, claiming methods of administering a blood test to calibrate necessary drug dosages in patients suffering from autoimmune diseases, to be directed to laws of nature.
The decision was an important one for the bio/pharma community, especially as it relates to the 101 analysis currently before the CAFC in the Myriad gene patent dispute.
However, when it comes to such patentable subject matter challenges under 35 U.S.C. § 101, there is currently no vehicle for a patent challenger to pursue such arguments before the USPTO. This is because patent reexamination is limited to patents and printed publications. Yet, challengers will occassionally test the bounds of the USPTO’s patience in this regard by infusing requests with extraneous commentary.
Last Monday, Merial Ltd, the animal health division of Sanofi Aventis, filed a request for ex parte reexamination of Genetic Technologies U.S. Patent 5,612,179. (90/012,276). The patent is directed to genetic tests for DNA markers found in cattle.
The request cites art that is intervening with respect to the effective filing date (i.e., earliest filed application) and the filing date of the underlying patent application that matured into the ‘179 Patent. In other words, if the claims of the ‘179 Patent are not supported by the earliest filed application consistent with the requirements of 35 U.S.C. § 112, the cited, intervening art, is properly considered prior art against the claims of the patent. (see earlier post on the filing strategy here and here)
Generally speaking, when asserting such an intervening art rejection, declaration evidence is typically advanced to demonstrate the lack of support in a parent application for a certain claimed feature. However, rather than take the traditional route, Merial has attempted to piggyback off of the Prometheus ruling, arguing:
The filing (here) continues by stating that the ‘179 Patent claims are “akin to the claims in Prometheus, explaining:
As made clear in MPEP 2258 (B), issues relating to 35 U.S.C. § 101 are not considered in patent reexamination. While Merial is not advancing a 101 rejection per se, the USPTO would have to agree that the claims of the ‘179 patent fail to meet 101 in order to reexamine them in the manner requested; this is not going to happen. Instead the 101 aspect of the request will simply be ignored.
So, aside from inexperience, why would a Requester go through the trouble of submitting all of this extraneous 101 discussion?
Often times, reexamination requests will include litigation inspired theories that Requesters are well aware will be of no consequence to the USPTO. Instead, such discussions are typically provided for the benefit of a judge in the parallel proceeding (i.e., where the filing is introduced as a status update or the like); perhaps such is the case here. Merial and Genetic Technologies are currently litigating the patent in Delaware. In some circumstances, filings of this ilk are referred to the Office of Patent Legal Administration (OPLA) for vacating of the filing date. (such as where inequitable conduct is alleged. See 95/001,259 (2/12/10)) Thus, such filing strategies are not without risk, and are best avoided.
Here, the 101 discussion is quite distracting, spanning a significant portion of the early discussion. Likewise, as Merial’s other arguments with respect to the 112 support are not based on declaration evidence, but just attorney argument, the request strategy could very well backfire by dooming the whole request to an outright denial.
As a result of the America Invents Act, challengers will be able to properly allege 101 deficiencies via a Post Grant Review (PGR), or Transitional Program for Covered Business Method Patents (TCCBMP) on or after September 16, 2012; until then….don’t try this at home.