The U.S. Patent and Trademark Office (“USPTO”) recently released October 2019 Patent Eligibility Guidance Update (“October 2019 Update”), which supplements the Guidance issued on January 7, 2019 (“2019 Guidance”).

In the October 2019 Update, the USPTO clarifies certain issues raised by the public comments in response to the 2019 Guidance and includes new examples. It is intended to assist Examiners in applying the 2019 Guidance. In particular, the October 2019 Update:

(i) Comments on what it means to “recite” a judicial exception. In particular, it explains that a claim “recites” a judicial exception when the judicial exception is explicitly “set forth” (as in Diamond v. Diehr[1], where a mathematical equation was clearly stated in the claims) or its concept is “described” (as in Alice Corp. v. CLS Bank[2], where the concept of intermediate settlement was described in the claims without explicit use of the words “intermediate” or “settlement”).

(ii) Provides additional guidance on identifying abstract ideas. In particular, in determining whether a claim recites an abstract idea, it directs Examiners to rely on the groupings of abstract ideas enumerated in the 2019 Guidance (rather than relying on individual judicial cases), and provides more information about the enumerated groupings (which include mathematical concepts, certain methods of organizing human activity, and mental processes). If a claim limitation does not clearly fall within the enumerated groupings, but the Examiner determines that it recites an abstract idea, the October 2019 Update directs the Examiner to bring the application to the attention of the Technology Center Director.

(iii) Explains how to evaluate whether a judicial exception is integrated into a practical application. 

Under the 2019 Guidance, the question of whether a claim is “directed to” a judicial exception in Step 2A of the eligibility analysis is evaluated using a two-prong inquiry.  Whereas Prong One asks if the claim “recites” a judicial exception, under Prong Two, a claim reciting an exception is deemed not to be directed to the exception if, as a whole, it “integrates the recited judicial exception into a practical application.” 

The October 2019 Update clarifies that all claim limitations, including those containing the judicial exception and the additional elements, need to be evaluated together to determine whether the claim integrates the exception into a practical application. The October 2019 Update confirms that, irrespective of whether it is an improvement over well-understood, routine, conventional activity, if the claimed invention reflects an improvement in the functioning of a computer or another existing technology, the claim integrates the judicial exception into a practical application, and thus, is patent eligible at Step 2A Prong Two of the analysis. The improvement can be provided by the additional element(s) or by the additional element(s) in combination with the recited exception. However, an improvement in the judicial exception itself is not an improvement in technology. 

The October 2019 Update refers to M.P.E.P. § 2106.04(a) and 2106.05(a) for a detailed explanation of how to analyze whether the claimed invention improves the functioning of a computer or another technology. In particular, the improvement has to be apparent to one of ordinary skill in the art based on the specification, and the claim has to reflect the disclosed improvement (i.e., include the components or steps of the invention that provide the disclosed improvement). Applicant can submit evidence under 37 C.F.R. § 1.132 to establish what the specification would convey to one of ordinary skill in the art (but not to supplement the specification).

The October 2019 Update further explains that when determining whether a claim applies the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant:

i. The particularity or generality of the treatment or prophylaxis. The Update explains that a limitation reciting administering a particular medication integrates an exception into a practical application, whereas a limitation merely instructing to apply the exception in a generic way, encompassing all of its applications, does not.

ii. Whether the limitation(s) have more than a nominal or insignificant relationship to the exception. The Update explains that a limitation reciting administering a medication that is not known in the art to have a connection to the recited law of nature does not integrate it into a practical application.

iii. Whether the limitation(s) are merely extra-solution activity or a field of use. The Update explains that a limitation reciting administering a vaccine in order to gather data for a subsequent mental analysis step (i.e., an abstract idea) is an extra-solution activity and does not integrate the abstract idea into a practical application. Conversely, if the mental analysis step is followed by a step reciting a particular vaccination schedule, such further step integrates the abstract idea into a practical application.

(iv) Reiterates that Examiners have the burden of establishing a prima facie case when making a subject matter eligibility rejection. The October 2019 Update refers to M.P.E.P. § 2106.07 for a discussion of what is required to make a prima facie case of ineligibility and, specifically, to M.P.E.P. § 2106.07(a) and (b) for a discussion of how to formulate subject matter eligibility rejections and evaluate Applicant’s response to the same.

(v) Provides remarks regarding efforts that have been made so far to provide Examiners with guidance and training on the application of the 2019 Guidance. It also notes that, even though failure by Examiners to follow the Guidance is not, by itself, a proper basis for an appeal or a petition, any Applicant whose claims have been twice rejected may appeal to the Patent Trial and Appeal Board (or employ other courses of action such as requesting an interview, contacting the Supervisory Patent Examiner, or filing a pre-appeal brief review request), and may rely on the Guidance to support the argument that a rejection under §101 is in error.

New Life Sciences Examples

The October 2019 Update includes new Examples 43-46. Here, we focus on two new life sciences examples – Examples 43 and 44.

New Example 43 illustrates the application of Revised Step 2A of the eligibility analysis to treatment claims. The discussed treatment claims read as follows:

1. A treatment method comprising:

 (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype;

 (b) administering a treatment to the patient having a non-responder phenotype.

 2. The method of claim 1, wherein the treatment is a non-steroidal agent capable of treating NAS-3.

 3. The method of claim 1, wherein the treatment is rapamycin.

 4. The method of claim 1, wherein the treatment is a course of plasmapheresis.

 5. A treatment method comprising administering rapamycin to a patient identified as having Nephritic Autoimmune Syndrome Type 3 (NAS-3).

The October 2019 Update indicates that claim 1 is ineligible. It discusses that, under Step 2A Prong One, limitation (a) recites a judicial exception (an abstract idea falling within the “mathematical concept” and “mental process” groupings in the 2019 Guidance, and a law of nature). Under Step 2A Prong Two, it finds claim 1 to be directed to a judicial exception because, as a whole, it does not require any particular application of the calculation recited in limitation (a), and at best merely adds the words “apply it” (as in Mayo v. Prometheus[3]), and thus, fails to integrate the exception into a practical application. Under Step 2B, it finds that the claim as a whole does not amount to significantly more than the recited exception. 

Claims 2-4, which depend on claim 1, are deemed eligible under Step 2A Prong Two. These claims are deemed not directed to a judicial exception because each of them requires administration of a specific treatment that bears more than a nominal relationship to the exception since it is particular to the identified phenotype, and thus, integrates the abstract idea into a practical application. In essence, the eligibility analysis of these claims follows U.S. Court of Appeals for the Federal Circuit decisions in Endo v. Teva[4] and Vanda v. West-Ward[5]. Notably, even though the treatments recited in claims 2-4 are conventional second-line treatments for NAS-3, this is irrelevant for the Step2A Prong Two analysis under the 2019 Guidance. The October 2019 Update indicates that whether a limitation is well-understood, routine or conventional is not taken into account at this Step.

 Claim 5 is deemed eligible under Step 2A Prong One because it does not recite, i.e., does not set forth or describe, any judicial exception.

In addition, this example notes that, generally, process claims are not subject to the markedly different analysis even if nature-based products are used in the process.

New Example 44 illustrates the application of Revised Step 2A of the eligibility analysis to product claims reciting nature-based product limitations. This example makes clear that the analysis of whether the claim as a whole integrates the judicial exception into a practical application, mandated by the 2019 Guidance, should also be applied, to nature-based product claims. The discussed nature-based product claims read as follows:

1. A dosage unit comprising denveric acid in a container.

2. The dosage unit of claim 1, wherein the container is a wearable delivery device having a flexible patch-shaped housing, a needle assembly mounted on one side of the housing, a reservoir located inside the housing in which the denveric acid is stored, a dosage control button mounted on the opposite side of the housing from the needle assembly, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly.

 3. The dosage unit of claim 1, wherein the denveric acid is an intermediate-acting denveric acid.

 4. The dosage unit of claim 1, further comprising protamine that is mixed with the denveric acid in the container in an amount of 0.75 mg to 1.5 mg protamine per every mg of denveric acid.

The October 2019 Update indicates that claim 1 is ineligible. It discusses that, under Step 2A Prong One, claim 1 recites a judicial exception because it recites a nature-based product limitation (the denveric acid) which does not have markedly different characteristics from its naturally-occurring counterpart. Under Step 2A Prong Two, it finds claim 1 to be directed to a judicial exception because, even though it specifies that the denveric acid is in a container, it covers any possible container (failing to meaningfully limit the claim), and thus, does not integrate the recited exception into a practical application. Under Step 2B, it finds that the claim as a whole does not amount to significantly more than the recited exception. 

Claims 2, which depends on claim 1, is deemed eligible under Step 2A Prong Two because the claim as a whole integrates the exception into a practical application. At this step, the October 2019 Update directs Examiners to analyze whether the judicial exception is applied with a “particular machine” using the three factors set forth in M.P.E.P. § 2106.05(b): (i) the particularity or generality of the elements of the machine or apparatus, (ii) whether the machine or apparatus is integral to achieve performance of a method, and (iii) whether its involvement is extra-solution activity or a field-of-use. Under these factors, it finds that the delivery device is sufficiently particular rather than generic and constitutes an integral part of the claim since it physically stores the denveric acid and controls the amount of the denveric acid to be injected. Although the delivery device recited in claim 2 is well-understood and routinely used to administer other medications, the October 2019 Update indicates that this is irrelevant for the Step 2A Prong Two analysis. While M.P.E.P. § 2106.05(b) instructs Examiners to apply the “particular machine” analysis in determining whether a claim recites significantly more than a judicial exception in Step 2B, the October 2019 Update adds this analysis to Step 2A. Thus, the analysis under the October 2019 Update may make it easier to convert a nature-based product claim into a claim that is not directed to a judicial exception, since Step 2A does not take into account whether the additional machine limitations are conventional.

Claim 3, which depends on claim 1, is deemed eligible under Step 2A Prong One because the claimed denveric acid has a marked difference in functional characteristics as compared to naturally-occurring denveric acid (i.e., it has intermediate-acting glycemic control characteristics as compared to short-acting characteristics of its natural counterpart), and thus, it does not fall under “a product of nature” exception. Even though the October 2019 Update discusses that this claim may be unpatentable for other reasons (such as indefiniteness or lack of written description), the recited marked difference in a functional property (even in the absence of a structural description of the product having such functional property) is sufficient to confer patent eligibility.

Claim 4, which depends on claim 1, is deemed eligible under Step 2A Prong One because, even though there is no indication that the mixing of naturally-occurring denveric acid and protamine components changes the structure of either component, the mixture has a marked difference in functional characteristics (i.e., the glycemic control characteristics of the mixture are different than the mere sum of the characteristics of its naturally-occurring components), and thus, it does not fall under “a product of nature” exception. The October 2019 Update further points out that it is not necessary for a claim to explicitly recite a functional characteristic that is markedly different, as long as the claimed product necessarily possesses at least one markedly different characteristic.