USPTO Releases New Guidance on Life Sciences Patent-Eligible Subject Matter

May 19, 2016
Post by Blog Staff

The United States Patent and Trademark Office has issued new guidance for Subject Matter Eligibility of Life Sciences patents. A memorandum with the subject "Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection" was released May 4, 2016. The Memorandum was accompanied by a new set of subject matter eligibility examples specific to the life sciences. The entire collection of USPTO interim guidance on subject matter eligibility may be found here.

The new memorandum emphasizes particular analyses that Examiners should employ when formulating a § 101 rejection. In step 2 of the two-step analysis from the Interim Eligibility Guidance (step 1 being to determine if the claim is directed to a statutory category of patentable subject matter), the Examiner should first identify the law of nature or natural phenomenon as it is recited and explain using reasoned rationale why it is considered such. If the claim is directed to a product of nature, the rejection should explain why the product does not have markedly different characteristics from its naturally occurring counterpart in its natural state. Finally, if the analysis reaches this point, the Examiner should then identify any additional elements recited in the claim beyond the judicial exception and explain why they do not add significantly more to the exception. The additional elements should be addressed both individually and as a combination. The memorandum stressed the importance of considering the additional elements as a combination "because while individually-viewed elements may not appear to add significantly more, those additional elements when viewed in combination may amount to significantly more than the exception by meaningfully limiting the judicial exception."

The memorandum further stressed the importance of explaining the Examiner's rationale underlying his or her conclusion so that applicant can effectively respond. For example, if the Examiner were to conclude that additional elements are merely directed to limitations that are well-understood, routine, conventional, the Examiner should provide reasoning and evidence to support that conclusion. "For example, even if a particular laboratory technique was discussed in several widely-read scientific journal or used by a few scientists, mere knowledge of the particular laboratory technique or use of the particular laboratory technique by a few scientists is not sufficient to make the use of the particular laboratory technique routine or conventional in the relevant field. Instead, the evaluation turns on whether the use of the particular laboratory technique was well-understood, routine, conventional activity previously engaged in by scientists in the field."

The Examples provided to accompany the memorandum examine hypothetical claims for inventions including vaccines, diagnosis and treatment of a disease, dietary sweeteners, screening for gene alterations, a paper making machine, and hydrolysis of fat. Each of the examples provide some background on the invention, sample claims, and a detailed analysis of the subject-matter eligibility of each claim. The analyses focus strongly on making the determination of whether differences between the claimed invention and its naturally occurring counterpart are enough to be a "markedly different characteristic." This analysis helps to define the line between naturally occurring and ineligible claims and eligible claims which are "markedly different." Further emphasis was placed on the significantly more analysis and applying the broadest reasonable interpretation to claims.

The "Pigeon flu" vaccine example provides a good look at the USPTO's recommended methodology for determining whether a claimed invention is a product of nature by applying the markedly different characteristics analysis. Under this analysis, a vaccine comprising Peptide F and a pharmaceutically acceptable carrier is not patent eligible, but a vaccine comprising Peptide F and a pharmaceutically acceptable carrier selected from the group consisting of a cream, emulsion, gel, liposome, nanoparticle, or ointment is patent eligible. 

The mixture of Peptide F and water (a pharmaceutically acceptable carrier) is compared to its closest naturally occurring counterpart. This combination doesn't take place in nature, so each component is compared individually. Then this is compared to the mixture. Mixing Peptide F and water does not change the structure, function, or other properties of the peptide or the water. The claimed mixture as a whole does not display markedly different characteristics compared to the naturally occurring counterparts. Therefore, this claim is ineligible.

By contrast, the Peptide F combined with a cream is eligible. The cream carrier is composed of cottonseed oil and water. The peptide, oil, and water do not naturally occur together in nature, so again the mixture is compared to its naturally occurring components. The claimed cream has different structural and physical characteristics than its naturally occurring components. The cream is a semi-solid and non-flowable substance at room temperature as compared to the oil and water individually, which are both flowable liquids at room temperature. Further, the cream will adhere to a patient's skin much longer than oil or water in their natural state. These qualify as marked differences in structural and physical characteristic as compared to their natural counterparts, so the cream is not a "product of nature" exception.

Another analysis demonstrated in the examples is determining if additional elements amount to significantly more than the exception. As was just discussed, a vaccine comprising Peptide F and a carrier is ineligible. Example claim 7 is directed to the same vaccine, but it is delivered with a microneedle array. Coating microneedles with Peptide F changes neither the structural or functional characteristic of Peptide F nor the structural or functional characteristics of the microneedles. So, this claim does not pass on the basis of "markedly different characteristics." However, if we move on to the question of whether there are additional elements that amount to significantly more than the product of nature, we are directed to the use of the microneedle array. At the time of application, coated microneedle arrays were a known technology, but were not routinely or conventionally used to administer vaccines. Therefore, addition of the limitation for using the microneedle array yields a claimas a whole which is patent eligible.

The remaining examples cover application of significantly more analysis to diagnostic and treatment claims using a hypothetical disease, application of markedly different characteristics and significantly more analyses to claims reciting hypothetical nature-based products including mixtures, and use of the streamlined analysis.

Overall, the examples serve to highlight the fine line between eligible and non-eligible subject matter for products of nature and natural phenomenon. The differences between the claims may be small, but it doesn't take much to change something from naturally occurring to man-made. This guidance should help practitioners to identify when the Examiner has not made a proper prima facie case for rejecting a claim under § 101 and provides further examples for practitioners to use for comparison to claimed inventions. The proper procedure for a § 101 rejection has been clarified, so practitioners can expect more reasoned § 101 rejections and be able to more effectively respond to such rejections.

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