From: Warren Woessner [e-mail address redacted] 
Sent: Wednesday, April 16, 2014 3:19 PM
To: myriad-mayo_2014
Cc: Warren Woessner
Subject: Feedback re: Examination Guidelines - Subject Matter Eligibility of 
Claims Reciting Or Involving Laws of Nature, Natural Phenomena & Natural 
Products

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 been 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 properites 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.)

There is Nothing in Recent Jurisprudence that requires Claims to “Simple” 
Diagnostic Assays to Recite Additional Inventive Features.

In the area of medical diagnostics, there was no reason for the Office to rule 
that a claim reciting a diagnostic conclusion based on a natural correlation is 
not patent-eligible unless there is some inventive aspect to the claim apart from 
the “If A, then B” recitation. Mayo (Prometheus) did not involve a diagnostic 
claim of this type – the Court simply believed that patentee had claimed the 
known correlation “too much drug – bad; too little drug – bad” that was known 
for 6-TP producing drugs like AZA. In fact, at the end of Mayo, the Court writes: 
“We need not determine here whether from a policy perspective, increased 
protection for discoveries of diagnostic laws of nature is desirable.” The Intema 
decision, that involved the use of two or more “old” diagnostic tests to improve
the diagnosis, is nonprecedential. The Fed. Cir. Myriad decision invalidated one 
broad diagnostic claim as an “abstract idea” but the Guidelines do not purport to 
rely on that exception to patentability. 

Finally, the Guidelines state that they are not applicable to “Medical Procedures”. 
This term occurs in 35 USC 287(c)(1) and clearly was intended to include 
diagnostic testing, so long as it did not cause infringement of the enumerated
 types of patents. There is simply no reason for the Office to strip simple 
diagnostic assays from the ambit of “Medical Procedures”. This is particularly 
true since the Guidelines do not apply to new uses for known compounds.

The Guidelines should be withdrawn for revisions to align them with recent 
Fed. Cir. and S. Ct. jurisprudence. Leaving them in place will compel millions of
dollars to be spent on litigation to reverse the decisions of Examiners who have 
been misguided by them.

Warren D Woessner, J.D. Ph.D.
Founding Shareholder
Schwegman Lundberg & Woessner, P.A.