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

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.


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