We previously discussed the new personalized medicine example in the USPTO’s October 2019 Patent Eligibility Guidance Update. Here, we look at the new nature-based product example, and consider how it may impact pharmaceutical product claims. 

New Example 44: “Denveric Acid”

New Example 44 illustrates how the USPTO should apply its patent eligibility guidance to claims relating to nature-based products, using the fictional “denveric acid” as an example. Example 44 includes 4 claims:

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.

Claim 1 is deemed ineligible, while all other claims are deemed eligible.

The Patent Eligibility Analysis of Claim 1

Analyzing claim 1, the guidance finds at Step 2A, Prong 1, that the claim recites a product-of-nature judicial exception (denveric acid). Overall, the guidance concludes that “the claim as a whole does not integrate the exception into a practical application or amount to significantly more than the exception because the additional limitation is at best the equivalent of merely adding the words ‘apply it’ to the claim.”

At Step 2A, Prong 2, the guidance explains that, although the claim includes an additional element (a container), “denveric acid must be placed in a container in order to store and use it,” and so “merely reciting a generic ‘container’ thus fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words ‘apply it’ to the judicial exception.” Accordingly, the exception is not integrated into a practical application.

At Step 2B, the guidance applies essentially the same reasoning as at Step 2A, Prong 2, and finds that the claim does not amount to significantly more than the judicial exception because “[m]ere instructions to apply an exception cannot provide an inventive concept.”

The ineligibility of claim 1 is arguably supported by the nonprecedential Federal Circuit decision in In re Baghat.

The Patent Eligibility Analysis of Claim 2

At Step 2A, Prong 1, the guidance finds that claim 2 recites a product-of-nature judicial exception (denveric acid). But at Step 2A, Prong 2, the guidance finds claim 2 not directed to the judicial exception, because the claim as a whole integrates the recited judicial exception into a practical application of the exception, via the recited delivery device. 

Information in the example indicates that the patent’s specification discloses that the “wearable delivery device is well-understood, and is routinely used to administer other medications.” But Step 2A, Prong 2, does not consider whether the additional limitations are well-understood, routine, and conventional, so the conventional delivery device still can support eligibility at Step 2A, Prong 2.

The guidance does subject the delivery device limitations to a “particular machine” analysis in accordance with MPEP § 2106.05(b), and considers (i) whether the device is recited with generality or particularity, (ii) whether the device is integral to the claim, and (iii) whether the device imposes meaningful limits on the claim. For this example, the guidance finds that the “delivery device is . . . a particular machine that applies or uses the denveric acid in a meaningful way that integrates this product of nature exception into a practical application.” 

The Patent Eligibility Analysis of Claim 3

To understand the patent eligibility analysis of claim 3, it is important to note information in the example that the patent’s specification discloses that naturally occurring denveric acid is short-acting, and that denveric acid must be modified to obtain an “intermediate-acting” form as claimed in claim 3.

Against that backdrop, claim 3 is found to be eligible at Step 2A, Prong 1, as not reciting a judicial exception, under a “markedly different characteristics” analysis. The guidance notes that, compared with naturally occurring denveric acid, “the claimed denveric acid has a changed functional property, in that it is intermediate-acting.” 

The Patent Eligibility Analysis of Claim 4

Claim 4 is an important example of a composition that includes two nature-based products. To understand this example, it is important to note information in the example indicating that the patent’s specification discloses that the combination of denveric acid and protamine results in a “long-acting” product. 

Claim 4 is found eligible at Step 2A, Prong 1, as not reciting a judicial exception because the composition as a whole has markedly different characteristics than either component separately.  The guidance explains that although “[t]here is no indication that mixing these components changes the structure of the denveric acid or protamine, . . . the mixture has a changed functional property . . . different than the mere ‘sum’ of the . . . characteristics of the individual components.” The claim thus does not recite a judicial exception.

Establishing Eligibility At Step 2A 

Example 44 as a whole illustrates several ways to establish eligibility at Step 2A (Prong 1 or Prong 2), and avoid a Step 2B analysis looking for “significantly more” than the natural product. Such an approach can be important because it may provide a route to eligibility without having to show that additional claim limitations are not “well-understood, routine, and conventional.” Indeed, it makes sense that even routine manipulations of a natural product should take it out of the judicial exception category, because even routine manipulations require “the hand of man.” This guidance should support the patent eligibility of pharmaceutical products comprising a nature-based product that has been modified in some way to modify its function, or that is formulated with another component such that the composition has a different function or effect.