Archive for August, 2009

PTO Issues Interim Examination Instructions for Patentable Subject Matter and Invites Comments

Monday, August 31st, 2009

On August 24, the PTO issued interim instructions (not rules) to guide Examiners post-Bilski. I did not see this as a major event, given that the Supreme Court will soon be reviewing the Bilski “machine or transformation” (M or T) test to see if it will continue to control the fate of process/method claims. However, the PTO recently invited comments and I cannot entirely resist.

In the first place, given that Bilski has already been applied to affirm rejection of a claim to a medical screening method (in Classen), it is a bit surprising that the “instructions” do not mention the application of Bilski to diagnostic, screening or surgical methods or to methods of medical treatment. The application of the instructions to the chemical arts is only mentioned directly twice, and once indirectly:

“For purposes of efficiency, it is recommended that the claim be first evaluated for the presence of the prong (M or T) most likely to be satisfied in the particular technological field because once one prong is satisfied, it is not necessary to evaluate the claim under the other prong. For example, in the mechanical and electrical arts, it may be more likely that a process is machine implemented, while in the chemical arts it may be more likely that a process results in a transformation of a substance.”

I agree, and as noted below in my post that discusses Classen, I remain at a loss to explain why the claim at issue was found by the Fed. Cir. to fail to recite the transformation of a substance. Remember, the claim was directed to a method of determining the efficacy of an immunization schedule to reduce the severity of an immune-mediated disorder that recited the step of immunizing a “treatment group” of animals. The PTO even defines “transformation” in the instructions in a way that would seem to include vaccination, which does transform one type of cell of the immune system into another kind:

“‘Transformation’ of an article [defined as “a physical object or substance”] means that the “article” has changed to a different state or thing…. A new or different function or use can be evidence that the article has been transformed.”

If the article is a T cell or a B cell, it would seem that Examiners are being instructed to ignore Classen and to continue to examine claims directed to (or reciting) immunization schedules. Good thing, with another the swine flu season looming.

The other oblique reference to chem/biotech claims is 8 lines from the end, where Examiners are instructed to:

“[c]onfirm that the [M or T] test was conducted correctly by considering whether the method is so abstract and sweeping as to have no real world application or pre-empts substantially all practical uses of a … law of nature or a natural phenomenon. In either case, the claim would be ineligible and should not have passed the M-or-T test.”

Although the fact we all have immune systems may be a natural phenomenon, the screening test claimed in Classen does not pre-empt all “uses” of the immune system or even of immunization; it is not even a method-of-treatment claim (which, after all, is another substantial use of immunization.

The only blatant misstatement of precedent in the instructions appears early on, where “A naturally occurring organism” is given as an example of non-statutory subject matter. This should be reworded as “An organism as it occurs in nature.” Pure cultures of microorganisms have been patentable at least since In re Bergy, 596 F.2d 952 (CCPA 1979). The court gave weight to Bergy’s expert who declared:

“The ‘biological pure culture’ of claim 5 is a well-defined product of the microbiologist which is capable of producing the desired antibiotic lincomycin under controlled fermentation conditions. In contrast, the soil source in which the microorganism was discovered is a complex microbial environment which, as such, could not be used to produce a desired product under any known fermentation conditions.”

The court recognized the importance of “bringing them back alive” from the jungle of nature. Thirty years later, we should not be having a debate to decide whether this is enough “transformation” to be worthy of a patent.


Federal Circuit Grants Ariad's Petition for Rehearing En Banc to Settle WDR Hash.

Monday, August 24th, 2009

At long last, the Federal Circuit will specifically address the questions of (a) whether or not section 112 contains a written description requirement separate from the enablement requirement and, if it does (b) what is its scope and purpose. Hopefully, if the answer to (a) is yea, the answer to question (b) will provide some guidance as to how to tell with some predictability when the WDR has been met (and when it has not), apart from the opinions of some of the judges that the description of the claimed subject matter must contain a concrete description of some sort, such as drawings, structural formulae, or the dreaded functional description that correlated to structure in some fashion by the art.

For some fairly deep background, please go back to my post of May 5, 2009 on Judge Linn’s dissent in Ariad, which discusses the difficulties that the Fed. Cir. has encountered in trying to provide guidance (let alone “standards” or “factors”) by which a specification can be weighed to determine if it has an adequate description of the invention. It is my opinion that there may well be enough votes to enshrine the WDR per se, but per so is where it will stay, as even resolving its scope and purpose is a far cry from providing any workable guidance as to how it can be met by mortal patent drafters. Amici briefs will be thicker than reporters at an Obama barbeque. Stay tuned

August 21 2008Ariad EnBanc Order Granting en banc Review.pdf

Warren Woessner Participates In Virtual Debate With Chris Hansen On The Myriad Lawsuit

Monday, August 17th, 2009

Cameron MacKendrick sponsors podcasts on issues of interest in IP law. In this one, I am trying to explain the debate surrounding both the patentability of “natural products” as well as the patentability of diagnostic assays and their relationship t

the young child

o the Bilski test for the patentability of methods in general. Chris Hansen, representing the ACLU, a plaintiff in the Myriad lawsuit, compares a patent claim to an isolated gene to an attempt to claim “gold isolated from gold ore.” Both are just products of nature, right? Do I hold my own? You decide.

JurisDiction Podcast

Journalism 101: Exergen Corporation v. Wal-Mart Stores, Inc.

Monday, August 10th, 2009

Attached below is an article by Ronald J. Schutz, Esq., that I think you’ll find interesting.

Journalism 101.pdf