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This distinction may work within the USPTO’s Step 2a/Step 2b framework, but a district court applying the Mayo/Alice framework should be able to find that a vaccine composition comprising an immunogenic protein and an adjuvant is directed to something “significantly more” that is eligible for patenting, even if the adjuvant is conventional. In Alice, the Supreme Court held that patent claims relating to mitigating settlement risk in financial transactions using a computer system were patent ineligible.Another question that arises from these examples is whether the “markedly different” test requires a difference that is “relevant to the nature of the invention.” The examples only discuss that concept when the nature-based product is not structurally different from its naturally-occurring corollary. In doing so, the Court set forth a two-part patent eligibility test: 1) Are the claims directed to a patent ineligible concept (e.g., abstract idea); and 2) If so, do the claims amount to significantly more than the patent ineligible concept itself?Further, since the 2015 Guidelines, the average number of patents issuing per month in these technology areas that have successfully overcome a 101 Rejection has increased.Thus, while obtaining a business method or software-related patent continues to be challenging post-Alice, the outlook is brighter for those pursuing patent protection.Does that mean that any structural difference will suffice but functional differences only support eligibility if they are “relevant” to the invention? 2347 (2014) (“Alice”) has had a significant impact on the patent eligibility of software-implemented inventions under 35 U. Following this decision, the United States Patent and Trademark Office (“USPTO”) issued multiple guidelines to aid Examiners in their review of patent applications under Alice.Creams Versus Microneedles How can a peptide formulated in a cream be patent-eligible with no further inquiry, while a peptide coated on a microneedle array only is patent-eligible if it was not conventional to do so? The first guidelines published on December 16, 2014 (“2014 Guidelines”), followed by an update that published on July 30, 2015 (“2015 Guidelines”).
The new guidance encourages examiners to consider claim elements in combination, as well as individually, when determining whether the claim as a whole amounts to significantly more.
Thus, the art unit is more important than ever and is a factor that should be considered when determining which aspects of an invention to pursue.