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USPTO Subject Matter Eligibility Guidance, the Federal Circuit and Diagnostic Method Claims: Clear as Mud?

In our January 22, 2019 Blog Post related to the January 2019 USPTO Subject Matter Eligibility Guidance (“the Guidance”), we noted that in Prong Two of Step 2A of the Guidance, an Examiner is tasked with evaluating “whether the claim as a whole integrates the recited judicial exception into a practical application of the exception.” More importantly, we commented that an Examiner may never have to consider whether additional elements “represent well-understood, routine, conventional activity” when determining whether the claim is directed to a judicial exception.  If the Examiner feels that the additional claim elements, no matter how routine or conventional, make the claim not directed to the judicial exception, then the analysis stops.  The claim is determined to be patent eligible.  As stated in the Guidance:

Prosecution, USPTO, Patent Eligibilty, Personalized Medicine
Author: Jeffrey K. Mills, Ph.D.

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Does USPTO Subject Matter Eligibility Guidance Muddy the Personalized Medicine Waters?

The USPTO’s recently revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 (“the Guidance”),  provides some clarity to Examiners and Applicants as to what constitutes an “abstract idea.”  While the Guidance identifies several abstract ideas that fall within the scope of a “Judicial Exception” during Prong One of the Alice/Mayo test (Step 2A of the Guidance), the Guidance specifically indicates that:

Prosecution, USPTO, Patent Eligibility, Personalized Medicine
Author: Jeffrey K. Mills, Ph.D.

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USPTO Revised Guidance for Subject Matter Eligibility, Effective January 7, 2019

On January 4, 2019, the USPTO announced revised guidance taking effect on January 7, 2019, for determining subject matter eligibility under 35 U.S.C. § 101 (“2019 Revised Patent Subject Matter Eligibility Guidance”).  The revised guidance supersedes all versions of the USPTO’s “Eligibility Quick Reference Sheet Identifying Abstract Ideas.”

USPTO, Prosecution
Authors: Minxi Rao, Cynthia M. Bouchez, PhD.

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USPTO Guidance for Application of 35 U.S.C. § 112 to Computer-Implemented Methods, Effective January 7, 2019

On January 4, 2019, the USPTO announced guidance on the application of 35 U.S.C. § 112 to computer-implemented inventions (“Examining Computer-Implemented Functional Claim Limitations for Compliance with 35 U.S.C. § 112”), which took effect on January 7, 2019.  The Guidance stated that for a computer-implemented 35 U.S.C. § 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function to avoid an indefiniteness rejection under 35 U.S.C. § 112(b). It is not sufficient to argue that one of ordinary skill in the art is capable of writing software to convert a general purpose computer to a special purpose computer (i.e., a computer programmed to perform the disclosed algorithm) to perform the claimed function.

USPTO
Authors: Minxi Rao, Cynthia M. Bouchez, Ph.D.

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