Guest Post: How to Patent Grapefruit Juice -- The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour

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.

Comments

[Skeptical]

Does anyone see the ironic humor evident in the elevation of form (for the gifted scriveners) over substance as reflected in the Office protocols for proper claiming?

Does anyone think that the Supreme Court (or even the Patent Office) can keep up with the creativity of the scriveners when it comes to the art of claim drafting?

Would it not make more sense to simply make the law of 101 more clear and less complicated by intricate notions of eligibility? Have not the Supremes themselves cast doubt on the Office protocols (as already noted in the recent Alice oral arguments)?

That no one else has already grasped these answers, and their implications, I am...

[Courtenay Brinckerhoff]

It's not interesting to see how the Guidance is being applied to real inventions with real commercial significance, it's embarassing.

[EG]

Anthony,

I completely agree with Courtenay that these Myriad Guidelines are embarrassing. Unfortunately for us and our clients, these Guidelines will be costly to deal with to get the patent protection our clients are entitled to. IMHO, the current USPTO hierarchy is out of control and acting ultra vires, the proposed "attributable ownerships" rules being another blatant example of unlawful rulemaking, harkening back to the "dark times" of the Dudas regime and the claim-continuation rules debacle.

[Skeptical]

Not to indulge in conspiracy theories (ok, to indulge just a little),...

Correlate the actions of the Executive Branch (and its contained Fourth Branch administrative agency of the Patent Office) - including in addition to the items shared by EG, the unbridled power of the too-closely-aligned Article I court of the PTAB and that court's recent indications of re-interpreting Article III court case decisions - all under a shadow realm of a non-vetted, no actual director in place (and not even nominated) Head of the Patent Office (the same office that still holds closed door meetings with powerful lobby groups)... all under the control and direction of a President who advocated clarity of government as one of his running planks...

Anyone else out there who is more than just a little...

[Vance]

Agreed Courtenay (and thank you for the great presentation on Friday).

The USPTO website says, "Driving Innovation, Not Litigation." I think they left out "away," as in "Driving Away Innovation, Not Litigation." The Guidance will be (and should be) litigated often.

I'm still searching for the case law that says if a composition of natural components can be "vibrated" into those natural components, then it is not patent eligible subject matter. Stunning (explosively stunning).

[Diana Cox]

Which organization of patent "customers" is going to take the lead in lobbying Congress to clarify 35 USC 100(a), 100(b) and/or 101 to fix this problem of "judicial exceptions to the plain meaning of the statute (which I suspect is what the USPTO is hoping their grotesque take on BRI of the Myriad/Mayo holdings will prompt their offended customers to do)?

[Leslie Fischer]

Well, Hans is certainly doing his best on the pharmaceutical/biotechnology side. I'm struck that the pomelo juice example is really a combination of American Fruit Growers mish-mashed up with Funk Brothers. Both wretched, but nonetheless part of our 101 history. What I found most odd about the USPTO forum on this subject matter the other day was the Office's statement that they were analyzing Myriad holistically -NOT just looking at the actual case and holding - but also considering the briefs, and oral arguments. I did hear that, right???

[Lawrence]

A problem with the USPTO example is that, in their claim 1, the preservative has a significant effect on the juice: it makes it stay fresh and drinkable longer than juice without the preservative. So even if the preservative doesn't change the structure of the juice, it does change a functional property of the juice. I think this distinguishes this claim from Funk Bros.

[Leslie Fischer]

Lawerence - this is true - the pomelo example is distinguished from Funk. But, pomelo is largely the same as American Fruit Growers. And here is the problem: the USPTO is mixing up the "rule" established by American Fruit Growers with the "application" of the rule.

Here is the "rule" from American Fruit:

manufacture = produce from the raw material an article for use which possesses a new or distinctive form, quality, or property.

And here is the (rather inexplicable) application of the rule:

Addition of borax to the rind of natural fruit does not change the name, appearance, or general character of the fruit.

I think most of us would agree that SCOTUS applied the rule of American Fruit to arrive at a rather odd conclusion ("You need a change in property. This orange doesn't have any different property." Huh?). But, nevertheless, that doesn't change the actual rule. That is, we can disagree as to whether there is a different "form, quality, or property" in a borax orange (yuck) but we should at least all agree upon the rule, which very clearly discusses changes in characteristics, properties and function.

Instead of trying to apply the "rule", the USPTO tries to simply align the pomelo juice hypo with the facts of American Fruit, and thus conveniently arrive at the same outcome. This allows the USPTO to do two things: 1) ignore the thorny problem that the American Fruit rule seems to contradict the American Fruit outcome; and 2) argue that only structure matters. Huh?

[Luc]

If you want to have an example on how far (and how problematic) the interpretation of such guidelines can go, you may see the Non Final Action mailed last week for 11/921,030. It appears that such cells isolated from human tissue are no more eligible to a US patent

[Skeptical]

Luc,

Page 2 of the OA seems to have misplaced claim 10...

(I do note that the claims supplied list it as withdrawn).

Other than that, and noting that the "non-oval" words do not appear to carry patentable weight (a conclusion I am open to amending), the claims rightly fail, as they appear to ONLY be claiming an item isolated that already has certain characteristics.

I do not see the problem here Luc.