USPTO: Initial Obviousness Finding, Burden Shifting Analysis and Avoiding Waiver of Patent Rights.

In a recent Federal Circuit Opinion, the Court confirmed the analysis to apply to an initial examiner and board’s finding of obviousness in light of the prior art references.  In re Huai-Huang,  the Federal Circuit vacated and remanded to the board its finding of obviousness of claim 1 of the ‘432 patent.  The ‘432 patent was assigned to Endo pharmaceuticals and involved claims to controlled release formulations of Oxymorphone to treat chronic pain.

Initially, the Examiner found claims 1 and 2o (the two independent claims) obvious in light of the Maloney reference (alone or in combination with the ‘248 patent).  The Maloney patent disclosed a different dissolution profile for Oxycodone and a controlled release of the opioid within the range recited in claims 1 and 20.  Endo presented several arguments in favor of patentability and non-obviousness of claim 1.  Endo presented arguments relating to unexpected results and significant commercial success of the controlled release of Oxymorphone for treating and managing chronic pain.

However, the Board and the Examiner discounted Endo’s evidence and held claims 1 and 20 prima facially obvious in light of the Maloney and ‘248 patent.  The Federal Circuit explained that the Board and the examiner committed an error in discounting Endo’s evidence of unexpected results and commercial success.  Although the Examiner presented a prima facie case of obviousness in light of the Maloney and ‘248 patent, Endo has sufficiently met its burden of rebutting the prima face case of obviousness by presenting evidence of unexpected results, commercial success and variances in dissolution profiles for Oxycodone and Oxymorphone.

Thus, the Federal Circuit, vacated the obviousness finding with respect to claim 1, and remanded the matter to the Board to consider the totality of the declarations and evidence offered by Endo on unexpected results, commercial success and variances in dissolution profiles of Oxycodone and Oxymorphone.  However, the Federal Circuit found that Endo had waived its rights to appeal the findings with respect to claim 20. Endo’s failure to properly present substantive arguments in support of patentability of claim 20 resulted in a waiver of rights to appeal the obviousness of claim of 20.

The in re Huai-Huang case teaches the importance of understanding the burden shifting analysis and presentation of rebuttal arguments in favor of patentability to ensure that an inventor receives the full scope of protection for his or her patent.  For more information see: In re Huai-Huang

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