Posts Tagged ‘patent claims’

More Questions Than Answers from the PTO

Wednesday, July 2nd, 2014

At the recent BIO International Convention, Deputy Commissioner Andrew Hirschfeld (who chaired the May PTO s.101 Forum) presented seven “Sample Claims” related to biotech/pharma inventions and invited “discussion and feedback” from the interested public. The claims have been posted on the PTO website (and can be found here). I will attempt some commentary on patent-eligibility under the new PTO Guidelines.

6. Antibiotic L, which is expressed by recombinant yeast. (Antibiotic L is secreted by a bacterial species and exhibits antibiotic properties when the bacteria functioning naturally)(Comments in parentheses are my slightly rewritten summaries of the background of the claims provided by the PTO in the slides.)

Patents4Life comments: We know that the Guidelines would require the Examiner to reject a claim to isolated antibiotic L or to a pure strain bacterial culture that would excrete the antibiotic into the medium–both are “natural products.” But in claim 6, a lot more of the hand of man is involved. But wait! This is a product-by-process claim and the PTO ignores process limitations when evaluating the patentability of a compound, and evaluates the compound per se. Now the “answer” turns on whether or not expression from yeast significantly alters the structure of antibiotic L, and we are not told whether or not it does. So the question is unanswerable at this point.


Lightning Ballast II – Judge Lourie Tries to Get to “The Facts of the Matter”

Monday, February 24th, 2014

After reading all 88 pages of this very scholarly opinion which left patent law right where it was post-Cybor – no matter how much weight the parties and amici felt stare decisis deserved – I went back and read Judge Lourie’s concurrence. It is mercifully brief and tries to cast some of the substantive issues in real-world contexts. He writes like a “Dutch uncle” – which the dictionary defines as one who “admonishes sternly and bluntly.” Whether or not you agree with his conclusions, he gets his points across like arrows in “The Hunger Games.”

He reduces the debate about the proper reading of Markman II simply by saying that the distinction between calling claim interpretation a “question of law” vs. a “question for the court” is not a substantial one. Whether or not the Supreme Court will disagree if cert. is granted is a question for another day.


Federal Circuit Reaffirms Cybor Standard in Lightning Ballast Rehearing

Friday, February 21st, 2014

On Friday, a narrow majority of the Fed. Cir. sitting en banc, reaffirmed that claim interpretation is a question of law, to be reviewed de novo upon appeal to the Fed. Cir. (A copy of the decision can be found below.) Judge Newman, for once writing for the majority, ruled that the weight of stare decisis tipped the balance toward not overturning the 1998 Cybor decision, also en banc, which established the de novo standard. Judge Newman wrote that Cybor properly implemented the Supreme Court’s ruling in Markman II (1992) that claim construction is a question of law, and not a question of fact or even a mixed question of law and fact.

She noted the difficulty the Fed. Cir. would face if it had to decide that “a fact was at issue” in any district court ruling on claim interpretation and noted that Cybor did not displace the lower court’s power to rule on many other issues, such as infringement, validity and damages.

Pens will be flying across the law review and blogoshere spaces for years analyzing this decision and I have not had time to read all of it this morning, but the traditional closing of “more later” is certainly an understatement.


Prometheus Unbound – Are Methods Of Medical Treatment The Next “Targets”?

Tuesday, May 22nd, 2012

In my March post “Unnatural Acts – Patenting Diagnostic Tests Post-Prometheus” I wrote:

“I have been trying to formulate diagnostic claims that would pass muster post-Prometheus and I am having trouble. If a researcher discovers the marker, the researcher should be able to patent it and ANY utility it has, including its use for the diagnosis/prediction of disease. Likewise if the researcher discovers a completely new utility for a known marker – e.g., as an  indicator of Alz Disease, this should meet the patent eligibility requirements of s. 101. However, the correlations that the researcher bases the assay claims on are still ‘natural phenomena’ according to Prometheus. So we patent attorneys are completely cycled back into the loop of [divining] what further steps are necessary to yield a patent-eligible claim for the new diagnostic correlation.”

Last night, a new monster crawled out from under the legal bed we have to lie in after Prometheus. It is not simply that diagnostic claims based on “If ‘a’ then ‘b’” naturally-occurring correlations are of doubtful patent-eligibility; we already know that Justice Breyer will exclude such diagnostic claims, such as the one involved in the “Metabolite Dissent,” the first chance he gets – so long as he can hold the Court together. The new monster is a modern Frankenstein stitched together from the language in Prometheus: