The USPTO has prepared interim examination instructions for evaluating patent subject matter eligibility under 35 U.S.C. 101 (Interim Patent Subject Matter Eligibility Examination Instructions) pending a decision by the U.S. Supreme Court in Bilski v. Kappos, and invited the public to submit written comments on the Interim Patent Subject Matter Eligibility Examination Instructions on or before September 28, 2009. See Request for Comments on Interim Examination Instructions for Evaluating Patent Subject Matter Eligibility, 74 FR 47780 (September 17, 2009).

Mary Till, Legal Advisor-Office of Patent Legal Administration at the U.S. Patent and Trademark, was speaking at the 11th Advanced Forum on Biotech Patents and mentioned that the USPTO has only received 9 comments to date.  Therefore, the USPTO is extending the comment period to ensure that members of the public have sufficient opportunity to submit comments on the Interim Patent Subject Matter Eligibility Examination Instructions.

A notice extending the comment period will be published in the Federal Register, and it will provide a new comment deadline of 30 days from the publication date of the notice in the Federal Register.  The USPTO will revise the instructions as appropriate based on comments received. Comments that have already been received are under consideration.

35 U.S.C. § 101 establishes the threshold for patentability by setting requirements for subject matter that is eligible for patenting. There are two criteria for determining subject matter eligibility and both must be satisfied. The claimed invention (1) must be directed to one of the four statutory categories (process, machine, manufacture, or composition of matter), and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below.

Note that the guidelines provide for the following:

A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step and should be rejected under § 101, for at least this reason. For example, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under § 101 as being directed to non-statutory subject matter.

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