Posts Tagged ‘Supreme Court’

Nautilus v. Biosig – Solving Insoluble Ambiguity?

Monday, June 2nd, 2014

Today the Supreme Court unanimously rejected the Fed. Cir.’s standard for resolving challenges to validity under s.112 para.2, based on whether or not a claim was “amenable to construction” and not “insolubly ambiguous”. Noting that Nautilus had urged that a patent is invalid when the level of ambiguity is such that “readers could reasonably interpret the claim’s scope differently” and that Biosig and the Solictor had argued s.112(2) is met when the patent provides “only” reasonable notice of the scope of the claimed invention, the Court attempted to reach a middle ground:

“Cognizant of the competing concerns, we read s. 112, para. 2 to require that a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty…[citing]” Markman, 517 U.S., at 389 (claim construction calls for ‘the necessarily sophistication analysis of the whole document,’ and may turn on evaluations of expert testimony.”

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USPTO Subject Matter Eligibility Guidance – 9th May Forum – Outcome and Opportunities

Friday, May 16th, 2014

Guest Post from Paul Cole, Lucas & Co., UK

As noted in postings in this and other blogs, controversy has been generated by the publication of new USPTO patent eligibility guidance for laws of nature, natural products and natural phenomena (Andrew Hirshfeld, 4th March). A forum hosted by the Office on 9th May provided an opportunity for feedback from organizations and individuals. Some 80 people attended in person and some 350 people watched via webcast. A replay is available via the USPTO’s webpage (http://www.uspto.gov/patents/announce/myriad-mayo.jsp) and slides from the presentations by the USPTO and by 9 of the 10 invited speakers are also available.

Perhaps the most important take-away message was that although the Office is unwilling to withdraw the guidance or to depart from the basic principles contained in it, it is recognised that development must be an iterative process. Until the end of June the public still has the opportunity to submit comments, suggest alternative interpretations and submit additional training examples. Andrew Hirshfeld went out of his way to say that he would love to see additional examples.

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Dolly Led to Slaughter – Part II

Friday, May 9th, 2014

As I read and re-read In re Roslin, App. No.  2013-1407 (Fed. Cir., May 8, 2014), before going across the street to “testify” at the PTO 101 Forum, I was struck by how the logical pathway chosen by the panel to deny claims to the famous cloned sheep could have gone the other way.

The panel followed the pathway: a) no naturally-occurring organism is patentable, b) Dolly’s DNA donor “parent” was not patentable, c) Dolly was identical to the donor parent in genetic make-up and d) Dolly is patent-ineligible under s. 101, since she exhibited no marked difference from the donor sheep.

This analysis let the panel sidestep  the fact that Dolly is “man-made”. An alternative analytic pathway is a) no naturally occurring organism is patentable, b) Dolly is a product of the hand of man and her difference from naturally occurring organisms is her “sameness”, e.g. her very existence is not a natural phenomenon, and c) Dolly meets the requirements of s. 101 and Chakrabarty as a patent-eligible product of human creativity. (I know Dolly is no more – I am just using the present tense for clarity.)

Of course, my alternative analysis was not adopted by the panel, but at least they did not refer to Dolly as a “product of nature” but rather ruled that she was unpatentable subject matter under s. 101. Maybe the Supreme Court will see it my way. It really should grant cert. if only to endorse the “markedly different” dictum in Chakrabarty that is currently the law of the land at both the Fed. Cir. and the PTO.

Another issue that needs resolution is whether or not the effort required to obtain a pure culture of cells (as in Bergy) or a purified natural product as in Parke-Davis is “creative” enough to avoid the curse of Funk Bros. But that’s now a story for another day.

Section 101 Fells Dolly: What Organism Is Next?

Friday, May 9th, 2014

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!

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