The USPTO has set up a new web page with resources for examining claims for patent subject matter eligibility, including a link to the slides used in training programs for Examiners in Technology Centers 1600 and 1700. While the slides hew closely to the Guidelines, they include additional commentary and examples that illustrate how the Guidelines might be applied in practice. One new example in particular feeds my concerns about the patent eligibility of pharmaceutical compositions under the Guidelines, and highlights where the USPTO’s interpretation of Supreme Court jurisprudence may have gone awry. 

The Pomelo Juice Example

The first example in the USPTO 101 training slides relates to claims directed to compositions comprising pomelo juice:

USPTO 101 Training Slides (67)

(This example is not in the Guidelines.)

The slides outline the analysis of this claim as follows:

Based on the plain and ordinary meaning of “preservative” in the art in light of the specification, the BRI encompasses the use of both naturally occurring preservatives such as vitamin E (a naturally occurring chemical) and non-naturally occurring and markedly different preservatives such as preservative X (a known preservative that is non-naturally occurring and markedly different from naturally occurring chemicals).

The BRI of the claim thus encompasses at least two embodiments:
1. pomelo juice and vitamin E; and
2. pomelo juice and preservative X.

 If any of these embodiments is ineligible, then the claim is ineligible.

The USPTO 101 Training Slides present possible arguments in favor of the patent subject matter eligibility of this claim, and provide these reasons for rejecting them:

UPTO 101 Training Slides (73)

According to the slides, amending claim 1 to recite specific amounts of juice and preservative would not be sufficient, because the juice and preservative ”would still be structurally identical to what exists in nature.”

The slides also consider this claim, which is limited to the non-naturally occurring preservative:

3. A beverage composition comprising: a) pomelo juice; and b) preservative X.

The slides indicate that this claim is patent eligible, but only after analysis “to determine whether the element in addition to the judicial exception (preservative X) adds significantly more to the judicial exception (pomelo juice).” In particular, the analysis finds that factors (b), (c) and (d) of the Guidelines are satisfied:

Factor b is satisfied.
The presence of preservative X is in addition to  the judicial exception (pomelo juice), and meaningfully limits the claim scope to a particular application of the natural product. There are many other ways in which the pomel o juice can be used/applied, e.g., a person can drink fresh-squeezed pomelo juice, a company can manufacture a pomelo beverage using a different preservative, the pomelo juice can be pasteurized, etc.

Factor c is satisfied.
Preservative X is more than nominally or tangentially related to the natural product, because it is part of the same composition with the pomelo juice, and it prevents the pomelo juice from spoiling (it retards the growth of bacteria that are naturally present in the juice).

Factor d is satisfied.
The presence of preservative X does more than describe the natural product (the pomelo juice). It is a specific instruction to use the natural product in a particular application.

What Does The USPTO Say About The Patent Subject Matter Eligibility Of
Pharmaceutical Compositions?

During the March 20 IPO Chat Channel webinar on the new Guidelines, I asked the USPTO’s Raul Tomayo how a pharmaceutical composition comprising a drug isolated from a natural source and an undefined “pharmaceutically acceptable carrier” would fare under the new Guidelines. He answered by emphasizing that there are “no per se rules” and that every claim will have to be analyzed on a “case-by-case basis.”

I don’t find that very reassuring, do you? 

(If you missed the webinar, you can purchase an on-demand recording from the IPO Chat Channel website.)

Where Do The Guidelines Go Awry?

Although the USPTO Guidelines purport to abide by a “claim as a whole” analysis, the framework mandated by the Guidelines requires Examiners to exclude any and all claim elements that fall under a “judicial exception” when considering whether there is “something else” that makes the claimed subject matter “significantly different” from a product of nature or natural phenomenon. For example, even though a “natural preservative” added to pomelo juice would have the same effects on the juice that support patent eligibility of claim 3, the Guidelines only permit consideration of the effects of the non-natural preservative.

While the USPTO cites the Supreme Court decision in Funk Brothers as requiring this exclusion, the USPTO’s focus on the structural differences that were missing from the claimed combination of bacteria at issue in that case overlooks the fact that the Supreme Court found that the combined bacteria had the same structure, function, and utility as the individual bacteria. In particular, the Supreme Court n Funk Brothers stated:

Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.

In the face of this clear discussion of the sameness of function and utility, I don’t believe that the fact that the Supreme Court in its Myriad decision chose to paraphrase the Funk Brothers holding as:

[T]he composition was not patent eligible because the patent holder did not alter the bacteria in any way.

means that the Myriad Supreme Court intended to foster an expansive “product of nature” exception that excludes all combinations of multiple “natural products” that have a different function and/or expanded range of utility than the individual components if the components are not somehow structurally different.

Havoc Ahead?

A composition comprising pomelo juice and a natural preservative is just as meaningfully limited in scope (factor b), just as changed by protection from spoiling (factor c), and just as focused on a particular application (factor d) as a composition comprising pomelo juice and an artificial preservative. An analytical framework that bases patent subject matter eligibility on such an insignificant difference as whether the added preservative is itself derived from nature or synthetic is going to wreak havoc on the U.S. patent system, particularly in the field of pharmaceutical products.