By Anthony D. Sabatelli* --
What does grapefruit juice, or more specifically pomelo juice, have to do with all this? I will get to that connection in just a bit. For those of you not in the know, a pomelo is a large, grapefruit-like citrus fruit with a mild, sweet flavor, but without the characteristic bitterness of a grapefruit. Now, on to the bitterness of the present situation.
On March 4th, the U.S. Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC § 101. The guidelines were issued in light of the Supreme Court's decisions in Myriad, Prometheus, and related cases. See, "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products." The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.
The Guidance sets forth a three-question inquiry with a complex twelve-factor analysis for determining whether a claim meets the criteria for patent eligibility under § 101. The first question is whether the claim is directed to one of the four statutory categories of patentable subject matter, i.e., a process, machine, manufacture or composition of matter. If the answer is "no", end of inquiry, and the claim is not patentable. If "yes", one proceeds to the second question, which is whether the claim recites a judicial exception to patentability. These exceptions are laws of nature (e.g., gravity), natural phenomena (e.g., wind), or abstract ideas (ideas in the abstract are not patentable -- only applications of the ideas are). If the answer to this second question is "no", the claim meets the eligibility requirements under § 101. If "yes", the next inquiry is whether the claim "as a whole" recites something "significantly different" than these judicial exceptions. This determination is made by analyzing the claim against the twelve factors -- six of which weigh toward patent eligibility and six of which weigh against.
If you think this analysis is complicated, even the USPTO thinks likewise. The Guidance actually states "[t]he determination of eligibility is not a single, simple determination, but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application." Perhaps even more concerning is that the Guidance goes on to state "[t]hese factors are not intended to be exclusive or exhaustive as the developing case law may generate additional factors over time." Need I say more?
So what does all this have to do with grapefruit juice -- um, I mean pomelo juice? The pomelo comes into play, because the USPTO used pomelo juice in a recent training slideshow presentation to its examiners.
The following three pomelo juice claims were analyzed under the Guidance.
Claim 1: A beverage composition comprising:
a) pomelo juice; and
b) a preservative.
Claim 2: A beverage composition comprising pasteurized pomelo juice.
Claim 3: A beverage composition comprising:
a) pomelo juice; and
b) preservative X.
Without going into excruciating detail -- I will leave that for when you accidentally squirt the pomelo juice in your eye -- the USPTO found the following.
Claim 1 is not patent eligible because it recites two components both found in nature, namely pomelo juice and a preservative (which in its "broadest, reasonable interpretation" would encompass vitamin E, which is another product of nature). The USPTO likened this claim to the mixture of naturally occurring bacteria at issue in Funk Brothers, a pre-biotech era Supreme Court case that said the mixture was not patent eligible, because the bacteria themselves were not structurally altered by being mixed together. In the present example, if instead the pomelo juice claim had specifically recited an artificial preservative, the USPTO would likely have come down in favor of patent eligibility.
Regarding Claim 2, the USPTO said this claim is patent eligible, because pasteurized pomelo juice is significantly different from what is found in nature.
As for Claim 3, the USPTO also determined this claim to be patent eligible. Assuming that preservative X is non-naturally occurring (the USPTO didn't state this upfront in the presentation), then this composition is also significantly different from what is found in nature.
Keep in mind that even though Claims 2 and 3 would be patent eligible under the Guidance, they still need to be further analyzed for patentability under § 101 (for utility and double patenting), under § 102 (for novelty), under § 103 (for obviousness), and also under § 112 (for written description, enablement, and best mode).
It will indeed be very interesting to see how the Guidance is applied as applicants begin to receive office actions on their biotechnology patent applications.
* Dr. Sabatelli is a Partner with Dilworth IP.
Image of Citrus grandis 'Honey White Brand' or 'Khao Nam Phueng' grown in Nakhon Chai Si, Nakhon Pathom province in Thailand (above) from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 3.0 Unported license.