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Expert Declarations Merit Special
Consideration In Patent Prosecution Says Federal Circuit
By Jane
E.R. Potter
[September 2007]
Experts, get your pens ready. The United States Court of Appeals
for the Federal Circuit has confirmed the importance of rebuttal
evidence, such as expert declarations, during patent prosecution.
In In
re Sullivan, __F.3d__, 2007 WL 2433841 (Fed. Cir. 2007),
the court directed the Board of Patent Appeals and Interferences
to consider on remand expert declarations that the applicant
had submitted.
The technology at issue in Sullivan relates to snake
antivenom, but the decision is broadly relevant beyond the specific
technology. Applicants Sullivan and Russell were pursuing claims
to an antivenom composition comprising fragments of antibodies.
The examiner rejected the claims as being obvious over publications
of the inventors and others. On appeal, the board agreed with
the examiner that all the claim limitations were found in a
combination of publications.
With the case back in the examiner’s hands, the applicants
amended their broadest claim, and the examiner again rejected
the claims over the previous combination of references. Applicants
appealed to the board once again, but the board upheld the rejection.
The board stated that three expert declarations already of record
related only to the intended use of the composition
as an antivenom and therefore did not consider them on the issue
of obviousness.
In their appeal, applicants argued that the three expert declarations
described how the prior art taught away from using the claimed
antibody fragments to neutralize rattlesnake venom. The Director
of the Patent and Trademark Office argued that the examiner
correctly gave the declarations no weight because they only
related to the use of the claimed composition.
The court reviewed the substance of the declarations. The
first one was filed in response to the first Office Action.
This declaration was submitted by an expert in developing snake
antivenoms, and it explained why a person skilled in the art
would not have expected fragments such as those claimed to effectively
neutralize venom. The court held that this declaration was relevant
because it stated that the prior art taught away from the claimed
invention. Teaching away is an important consideration
for rebutting an obviousness rejection.
The second declaration was by one of the inventors, Sullivan.
It explained in detail the properties of whole antibodies and
fragments of antibodies, and stated that experts believed that
the claimed fragments would not be effective against
the toxic effects of venom. The court held that Sullivan’s
declaration was relevant because it described an unexpected
property or result from using the claimed antibody fragment
as an antivenom. Unexpected property can be evidence
of non-obviousness.
The third declaration was by the other inventor, Russell,
and provided further discussion of why those of ordinary skill
in the art expected antivenoms such as those claimed to fail.
The court found that the board was mistaken in asserting that
the declarations only related to the use of the claimed
compositions. The court found that the declarations did more.
Specifically, they (a) purported to show an unexpected result
from use of the claimed composition; (b) explained how the prior
art taught away from the composition; and (c) demonstrated
a long-felt need for the new antivenom composition.
The board also made clear that an unexpected property of a new
composition is distinguishable from a new use of a known composition.
Declaration evidence of secondary considerations, such as those
discussed above, are relevant to overcome an obviousness rejection.
The lesson from this case is more of a reminder: declarations
from experts and from the inventors may be filed during prosecution
and must be given weight by the examiner. This is particularly
true in a complex field such as antibodies. The inventors’
own explanations of how the new antivenom differed from existing
antibodies provided technical details that are more appropriately
supplied by the inventors than by attorney or agent argument
alone. Thus, while attorney or agent arguments may parallel
and repeat arguments made in a declaration, the examiner and
the board must give the arguments in the declaration special
consideration.
It can be helpful early in patent prosecution to begin identifying
potential experts and to contact them and determine their willingness
to help. Once an Office Action has been received, there is usually
a three-month deadline for replying, with an additional three
months available for a fee. Taking such extensions, however,
may reduce the ultimate patent term. Involving an expert early
can translate to more time for drafting a suitable declaration,
identifying relevant data, and preparing arguments before the
three month deadline.
Finally, expert testimony need not be limited to written declarations.
A personal interview with the examiner, and the supervisory
examiner if appropriate, can include one or more inventors,
representatives of the applicant, and experts. Telephone conferences
with the examiner can also be held. Both approaches may help
resolve issues of complex technology more efficiently, and can
supplement the written arguments.
For further information, please contact:
This Life Sciences Advisory Bulletin is a publication of the
Life Sciences Group of Davis Wright Tremaine LLP. Our purpose
in publishing this Advisory Bulletin is to inform our clients
and friends of developments in life sciences law. It is not
intended, nor should it be used, as a substitute for specific
legal advice as legal counsel may be given only in response
to inquiries regarding particular situations.
Copyright © 2007,
Davis Wright Tremaine LLP.
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