From: Liebeschuetz, Joe [e-mail address redacted] 
Sent: Tuesday, April 01, 2014 4:18 PM
To: myriad-mayo_2014
Subject: Guidance

There are a number of problems with the guidelines
1.	They arguably involve substantive rulemaking in areas the courts have 
not yet addressed.
2.	They were not subject to prior public comment.
3.	They appear to transfer the burden of proof to the applicant rather than 
the Patent Office. 
4.	They suddenly introduce a frequently occurring complicated analysis 
for an issue that was previously rare and then usually simple to address. 
5.	Many applications (e.g., fireworks) will be ensnared in the analysis 
because of involving in some respect a natural product.  Although most such 
applications will ultimately escape by balancing of the factors, it is a waste of time 
to go through for the entire analysis for claims that no one would consider to be 
natural products.
6.	Some claims that were previously considered patentable appear no 
longer to be (isolated products, mixtures of isolated products, broadly defined
methods of treatment with an isolated natural product).  Such a position denies 
established expectations without clear mandate by the courts or legislature.
7.	It is unclear from the guidelines whether antibodies will be considered 
to involve a natural product and if so, whether they can escape based on balancing 
of the factors.  Presumably this is a case by case analysis
8.	The balancing factors are highly redundant with one another making the 
analysis unnecessarily complex.
9.	The complex framework for determining patent eligible subject matter 
places the US outside international norms.  Although other jurisdictions have 
exceptions from patentable subject matter, they are usual in narrow well-defined 
areas.  By contrast, the guidelines introduce a widespread regime ensnaring a 
large proportion of applications in the biotech and chemical arts with escape from 
the regime being based on a complex balancing of factors. 
 
Joe Liebeschuetz
 
Alston + Bird LLP
275 Middlefield Road, Menlo Park, CA  94025-4004 
[e-mail address redacted] 
Direct 650.838.2038  |  Mobile 650 575 8259 | Fax 650.838.2001 
www.alston.com