Section 101 Fells Dolly: What Organism Is Next?

Posted on May 9, 2014 by Warren Woessner

On Thursday, a panel of the Fed. Cir. affirmed a board decision refusing a patent claim to an animal prepared by adult cell cloning (a copy is available at the end of this post). Specifically, the patent claims covering “Dolly” the cloned sheep were held invalid on the basis that Dolly is a “product of nature” that, although man-made, does not exhibit “markedly different characteristics” over its DNA donor sheep.

While this was a predictable outcome, Roslin Institute might have developed a factual record that would have supported their arguments that there were genetic differences between the two animals. More disturbing is the emphasis on the need for “markedly different characteristics from any found in nature.” This is dictum from Chakrabarty that seems reasonable enough when dealing with biofactories like Chakrabarty’s bioengineered bacteria. However, language in this opinion gives me the uneasy feeling that the Fed. Cir. is poised to repudiate In re Bergy II. This decision, vacated by the S. Ct., held that pure cultures of microorganisms that excrete lincomycin, are patent-eligible due to the beneficial results of removing the bacteria from the jungle of nature and taming them into useful organisms.

At pages 6-7 of the Slip Op., Judge Dyk writes: “Accordingly, discoveries that possess ‘markedly different characteristics from any found in nature’…are eligible for patent protection. In contrast, any existing organism or newly discovered plant found in the wild is not patentable [citing In re Beinke for the proposition that a plant discovered in the wild is not patent-eligible, “in part because such a plant was not in any way the result of the [applicant’s] creative efforts or indeed anyone’s creative efforts.”

Well now, were the pure cultures in Bergy II the result of “creative efforts”? Was vitamin B12 or adrenalin? (And why is Judge Dyk using language usually reserved for poets and painters?) I am speaking on “markedly different” at the PTO 101 Forum on May 9th. This storm front is about to become even more threatening. Take cover!

13-1407.Opinion.5-6-2014.1

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , | 1 Comment

In re Bergstrom – A Lost Precedent That Should Be “Found”

Posted on May 2, 2014 by Warren Woessner

Since I do a lot of commentary, I read a lot of commentary, and have been struck by how the PTO s. 101 Guidelines on “Laws of Nature” have been criticized as if they are free from the constraints of precedent. The PTO’s long-established practice of issuing patents on products of nature that have been purified until they are, in fact, new compounds, has been largely analyzed as if it is sui generis – as if the Office had been doing us a favor for all these years, and has finally seen the error of its ways, thanks to Myriad.

Some of the fault must be laid, however gently, at the feet of Judge Lourie. In both of the Fed. Cir.’s Myriad opinions, he wrote in footnotes (11 and 7 respectively) that In re Bergy, 596 F.2d 952: “is no longer binding law” since it was vacated by the Supreme Court. I, and some other commentators, have criticized this statement as contradictory to the language in Chakrabarty to the effect that the petition for cert. was granted for the combined appeals in Bergy and Chakrabarty, but then Bergy was remanded for dismissal as moot. In fact, I looked at the actual Supreme Court order, 444 U.S. 1028, and it states that the judgment was vacated as well. My bad.

Continue reading →

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , | Leave a comment

Isolated DNA and the “Hand of Man”

Posted on April 28, 2014 by Warren Woessner

Editors Notes: Apart from a fine survey of the case law on patent-eligibility of not-so natural products, Paul Cole suggests that, in view of the incomplete and/or indirect description of the BRACA sequences that Myriad claimed, there may well be isolated, purified and sequenced fragments of the human genome that would meet the test of being markedly changed in character from their state as a portion of genomic DNA. In other words, perhaps this is not the time to throw in the towel on patenting probes and primers.

Whether or not there is a need for modification of the proposed USPTO natural product eligibility guidelines (a PDF is provided at the end of this post) depends on the interpretation of four Supreme Court opinions, Funk Brothers, Chakrabarty and Myriad which relate to products and Mayo which relates to treatment methods.

Inclusion of an example based on Funk Brothers is arguably unwise having regard to the internal conflicts within the majority opinion, the divisions within the Court and conflict with a number of earlier Supreme Court decisions. The majority opinion is arguably in conflict with Hartranft v.Wiegmann, cited in both Chakrabarty and in Myriad, and supporting the proposition that a product is likely to be regarded as involving human ingenuity if it has been put into a new form and new utility results. The evidential nature of a new effect or result has been known since at least 1822 in Evans v Eaton, see also Webster Loom v Higgins and Carnegie Steel v Cambria Iron, and the primary reason for rejection of that new result evidence in Funk Brothers was on the arbitrary ground, that what had been achieved was “hardly more than an advance in the packaging of inocculants” and a commercial rather than a technical benefit.

Continue reading →

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , , | Leave a comment

USPTO Forum to Discuss the Guidance on Subject Matter Eligibility of Claims Reciting Laws of Nature

Posted on April 16, 2014 by Warren Woessner

On May 9th the Patent Office is hosting a forum to receive public feedback from organizations and individuals on the “Guidance”(link below). As followers of Patents4Life are well aware, I have not been shy in posting my opinions regarding patenting inventions based on a number of the “Laws of Nature.” Below is my attempt to summarize some of the points of my commentary as written feedback to the PTO. If you invent or prosecute in this arena, you are already aware that Examiners are locating laws of nature, natural products, etc. in claims of all sorts, stripping away the other claim elements as conventional procedures and rejecting the claims as attempts to monopolize “natures handiwork.”

The Guidelines Contravene Decisions of the Fed. Cir./CCPA That Should Guide the Patenting of “Natural Products”

The extension of the Myriad Supreme Court decision barring patents on fragments of DNA isolated from the human genome did not require the formulation of PTO Guidelines barring patents on “Natural Products” unless they are structurally altered from their condition in nature (e.g., in their natural source). In re Bergy and In re Bergstrom make it clear that isolation alone can impart s.101 novelty to natural products that are isolated and purified from their natural sources. (Bergy is precedential, Judge Lourie’s opinion notwithstanding, as can be ascertained from the description of the history of the Bergy and Chakrabarty cases as it is reproduced in Chakrabarty. What the Office should be “measuring” in the extent in change in physical properties and/or practical utility that results from the isolation/purification. A gold nugget may be minimally changed from its physical properties and/or practical utility when it is panned out of a stream. However, the microorganisms in question in Bergy and the prostaglandins in Bergstrom were of no practical use in their natural state, but became valuable biofactories or drugs following extraction and purification. (The ACLU also conceded that the isolation of a drug that occurred in a very low concentration in a tree could render it patentable, since a controlled dosage could be given.)

Continue reading →

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , | Leave a comment