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.

By Donald Zuhn —

Last Friday, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4.  According to the Office's Guidance webpage, the forum was intended to provide an opportunity for stakeholders to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination.

After USPTO Deputy Director Michelle Lee welcomed attendees and viewers to the forum, Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, provided opening remarks on the Guidance, and then Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration, provided an overview of the Guidance.  Following Mr. Hirshfeld and Mr. Tamayo were several public presenters, who were divided into three groups, with each presenter being given 10 minutes to provide feedback on the Guidance.  The first group of presenters consisted of Dr. Hans Sauer, Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization; Suzannah K. Sundby of Smith, Gambrell & Russell, LLP; Dr. Anthony D. Sabatelli of Dilworth IP LLC; and Dr. Kenneth H. Sonnenfeld of King & Spalding LLP.  The second group of presenters consisted of Courtenay C. Brinckerhoff of Foley & Lardner LLP; Dr. Leslie Fischer of Novartis Pharmaceuticals Corp.; and Dr. Warren D. Woessner of Schwegman Lundberg & Woessner, P.A.  The final group of presenters consisted of Barbara Fiacco of Foley Hoag, representing the American Intellectual Property Law Association (AIPLA); Duane C. Marks of Roche Diagnostics Operations, Inc.; and Gregory A. Cox of Eli Lilly and Company, representing the American Bar Association Section of Intellectual Property Law (ABA-IPL).  Following the public presentations, the forum concluded with a hour of open participation, where USTO representatives answered questions from attendees and viewers and accepted public statements from those in attendance.

In his opening remarks, Mr. Hirshfeld (at left) noted that the process of crafting examination guidance is an iterative one in which the Office responds to significant decisions (such as Myriad) by moving as quickly as possible to get guidance to examiners, and then going back and developing further guidance, if needed, following public input and feedback.  Anticipating a question that he sensed was on the minds of most attendees, Mr. Hirshfeld indicated that he did not know what (if anything) would change in the Guidance as a result of public input and feedback, but suggested that "everything is on the table."  However, Mr. Hirshfeld declared that the Office strongly believes that the Guidance is based on principles mandated by case law (although he acknowledged that the challenge was in applying these principles).

For those who had attended the April 16 biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting, Mr. Tamayo's (at right) overview of the Guidance was probably quite familiar.  In addition to reviewing the new examination procedure set forth in the Guidance for determining the subject matter eligibility of claims under 35 U.S.C. § 101, Mr. Tamayo also raised and answered several questions regarding the Guidance.

With respect to the question of why, in view of Myriad, the Guidance concerns anything more than DNA, Mr. Tamayo noted that the Guidance is not limited to Myriad, but considers a number of other Supreme Court decisions dealing with subject matter eligibility.  Mr. Tamayo also explained that the Guidance was so comprehensive because the relevant case law was so woven (as shown in the slide below).

In response to the query about why the Guidance gives short shrift to the word "discovery" in 35 U.S.C. § 101 ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . ."), Mr. Tamayo noted in his presentation that "[o]ver the last 65 years, the Supreme Court has repeatedly explained that a mere discovery of nature’s handiwork is not eligible" (emphasis in original).  In support of the proposition that "discovery" is not enough for eligibility, he cited to four of the Court's decisions:

Mr. Tamayo next addressed the origin of the Guidance's "significantly different" standard, indicating that the phrase is meant to capture the two pathways to eligibility described in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).

Noting that the Court's decision in Myriad had changed the Office's understanding of the law, he explained that isolation or purification of an otherwise unchanged naturally occurring product could no longer be viewed as eligible subject matter.  According to Mr. Tamayo, the Federal Circuit's recent decision in In re Roslin added another data point that the proper test for all natural products — and not just DNA — was the "markedly different" standard of Chakrabarty.  With respect to the question of why the Office limited the marked difference analysis to structure, he explained in his presentation that the "Supreme Court has never held a claim reciting a natural product eligible unless it was structurally different than what exists in nature," citing to four of the Court's decisions (as shown in the slide below).

As to whether a functional difference could be used to establish a marked difference, Mr. Tamayo stated that the Office's response was "no."  In support of the Office's conclusion, he noted that while briefs submitted in the Myriad case had argued that the claimed DNA at issue in that case performed functions that native DNA could not, such arguments "did not alter the Court’s decision that eligibility hinged on a markedly different structural change."  That being said, Mr. Tamayo indicated that the Office was "open to hearing alternative interpretations and considering examples."

In lieu of convincing the Office to consider functional differences, and in the event that an applicant's claims recite molecules that are identical to naturally-occurring products, Mr. Tamayo suggested two ways to make such claims eligible:  (1) by excluding embodiments from the claim that do not possess markedly different characteristics, or (2) by combining the natural product with something that adds significantly more to the natural product (as shown in slide below).

Mr. Tamayo next addressed what he called the Guidance's most "explosive" example, Example C.

He explained that the example was intended to emphasize the important role of using the broadest reasonable interpretation (BRI) when analyzing claims for subject matter eligibility.  Mr. Tamayo noted that the Office's assertion in the Guidance that "calcium chloride and gunpowder as recited in the claim are not markedly different from what exists in nature" had drawn feedback in the patent community ranging from "disagreement to vociferous disagreement (with more of the latter)."  As in the Office's BCP presentation, Mr. Tamayo described the four types of gunpowder (simple mixture, corned gunpowder, glazed powder, and white powder) and explained that the simple mixture is not markedly different because none of the components (potassium nitrate, sulfur and charcoal) have been structurally changed.  He then explained that as a result of BRI, examiners and applicants might look at gunpowder differently (as shown in the slide below).

Mr. Tamayo concluded his presentation by answering one last question:  whether gunpowder was per se ineligible.  His response was "no," but only because, as he reminded everyone, the new examination procedure did not establish bright line rules.  He pointed out, for example, that an applicant might expressly disclaim a broad interpretation of gunpowder in the specification or use claim language that demonstrates that the particular claimed gunpowder is markedly different.

A copy of Mr. Tamayo's presentation can be found here.

In a subsequent post, we will examine the response of public presenters.

For additional information regarding this topic, please see:

• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014