Federal Circuit Opinion On Myriad Remand

Today, the Federal Circuit issued its opinion following GVR from the Supreme Court in AMP v. USPTO and Myriad Genetics, Inc., App. No. 2010-1406 (August 16,2012). (A copy of the opinion is available at the end of this post.) Unfortunately, the opinion, authored by Judge Lourie and joined in part by Judges Bryson and Moore, contained nothing to give hope that diagnostic methods resting on natural correlations would be patentable in the future.

The panel began with 36 pages on the standing issue, holding that only Dr. Ostner, who had received a “licensing letter” from Myriad, had standing to pursue this action.

Pages 35-55 of the 62 page majority opinion focused on the claims to isolated DNA molecules, clarifying that “[i]solated DNA is not just purified DNA…but is different in name, character and use.” Judge Lourie wrote that isolating a sub-unit molecule by breaking covalent bonds is not a trivial alteration, since the covalent bond is the “defining boundary” between one molecule and another. Slip op. at 46-48.

Claim 20, directed to the use of transgenic BRCA gene-containing cells to screen for anti-cancer drugs, was likewise held to be patent-eligible, since the “underlying subject matter is man-made.”

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USPTO Publishes Rule Package on AIA Administrative Trials

While this is primarily a biotechnology patent law blog, the USPTO’s high level of rule making activity deserves attention, as it will affect us all after the September 16th deadline for implementing many of the new features of the AIA passes. Today, the PTO publishes over two hundred pages of regulations, guidelines and “Rules of Practice’ regarding Inter Partes Review, Post-Grant Review, the Transitional Program [to attack] Business Method Patents, Supplemental Examination (to “purge inequitable conduct”) and the new procedures by which a person having rights to the invention can file an application in lieu of the inventor(s).

Below are links to the six USPTO Federal Register Notices –

Changes to Implement Inter Partes Review Proceedings, Post-Grant Review Proceedings, etc.


Changes to Implement Inventor’s Oath or Declaration Provisions of Leahy-Smith America Invents Act


Changes to Implement Supplemental Examination Provisions of Leahy-Smith America Invents Act and Revise Reexamination Fees


Office Patent Trial Practice Guide


Rules of Practice for Trials before Patent Trial and Appeal Board and Judicial Review of Decisions


Transitional Program for Covered Business Method Patents: Definitions of Covered Business Method Patent and Technological Invention

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“Global Dossier” May Lead to IP5 “One Portal” Filings

As reported in Director Kappos’ blog, progress is being made in harmonizing the patent filing process in the IP5 countries. This may be as big an advance in patent law as the EPO – including our hope for a single EU patent. Wish everyone, “Full faith and credit.”

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“APPLICATION DENIED”- PROMETHEUS IN ACTION

A mathematical equation, even directed toward solving a particular problem, cannot be patented. Prometheus (“Mayo”) 132 S. Ct. at 1299. However, in Diehr, the S. Ct. stated, hopefully, that “[a]n application of a law of nature or a mathematical algorithm to a known structure or process may well be deserving of patent protection.” Diehr, 450 U.S. at 1987. Post-Mayo, we have seen precious few examples. In a recent Bd App decision, Ex parte Potts, App. No. 2011-004700 (July 18, 2012), the Board entered a new ground of rejection, patent-ineligibility under 101, to send the application back to the Examiner. The main claims did sound broad, and involved preparing a self-organizing map (SOM) – by topographical data mining (?) from outcomes of previously treated  patients, generating a similar SOM for the patient – insofar as possible – and comparing them to predict whether or not the patient would respond  to a given treatment.

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