Transcript Scope: Enemy of Term? Recent Decisions Impacting Scope

Scope: Enemy of Term?
Envisioning the Future
Scope of Claims: Impact
of Recent Decisions
Vicki G. Norton
San Diego
AIPLA
Spring 2009
The views expressed herein are my own and do not reflect the views of other
speakers on the panel, clients or of Duane Morris
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The Patent Squeeze
102
In re Gleave
In re Chuang
112
103
Ariad v. Eli Lilly
ICU Medical
KSR
In re Kubin
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SCOPE: ENEMY OF TERM
HELD NOT PATENTABLE (35 U.S.C. § 102)
In re Gleave
CLAIM
PRIOR ART DISCLOSURE
“bispecific antisense
●List of all 15-nucleotide sense
oligodeoxynucleotide” oligos (>1400)
. . . “of sufficient length to ●States antisense oligos can
act as an antisense
interact with sense oligos, 15inhibitor” of IGFBP-2 and mer to 25-mer, bispecific
IGFBP-5”
● Knowledge of how to make
[claims now limited to
oligos
[surprisingly] most active 20●No understanding of which
mer) & modified forms]
targets would be useful
●[
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SCOPE: ENEMY OF TERM
HELD NOT PATENTABLE (35 U.S.C. § 102)
In re Chuang (Bd.)
CLAIM
PRIOR ART DISCLOSURE
“An isolated
polypeptide
comprising the
amino acid
sequence of SEQ
ID NO:1.”
●DNA
sequence in an article
annotating a mouse cDNA
library + disclosure of
corresponding protein
sequence (w/o isolation of the
protein)
●Reiterates prior art need not
disclose use or utility
4
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SCOPE: ENEMY OF TERM
HELD NOT PATENTABLE (35 U.S.C. § 103)
In re Kubin
CLAIM
PRIOR ART DISCLOSURE
“isolated nucleic acid
molecule . . . encoding a
polypeptide at least 80%
identical to amino acids
22-221 of SEQ ID NO:2 . .
.”
Specification referred to
same treatise mentioned
in prophetic example
[qualify when
conventional methods
used]
Obvious to try + reasonable expectation
of success applied to less predictable
art
●[
1st reference:
●Monoclonal
AB to “p38” [commercially
available]
●Prophetic disclosure of conventional
methods (citing treatise) for use in
obtaining p38 cDNA
●No p38 isolation or protein sequence
2nd ref: cloned mouse analog
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5
SCOPE: ENEMY OF TERM: 35 U.S.C. § 112
Ariad v Eli Lilly
CLAIM
LACK OF WRITTEN
DESCRIPTION
A method for . . .
“reducing NF-κB activity”
comprising “reducing
binding of NF-κB to NFκB recognition sites on
genes which are
transcriptionally
regulated by NF-κB.”
Single step method did not
refer to molecules in a class
exemplified by
representative species
●[
•Specification referred generally to 3
classes of molecules covered by claim
that would decrease activity, only one
of which was arguably described
•No working or prophetic examples of
molecules reducing NF-κB activity; no
completed syntheses of any molecules
prophesized to have activity
•State of the art was “primitive and
uncertain” so couldn’t fill the holes in
disclosure.
[See also, In re Alonso]
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6
SCOPE: ENEMY OF TERM: 35 U.S.C. § 112
ICU Medical v. Alaris
CLAIM
Claims to needleless
connector valves
comprising a body and a
seal;
LACK OF WRITTEN
DESCRIPTION
No description of
“spikeless” valves covered
by claims which do not
recite a “spike” element.
claims omitted “spike”
limitation present in all
disclosed embodiments
Draft embodiments with
and without elements
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SCOPE: ENEMY OF TERM
AVOID LATE-DISCOVERED ART
●
Do search & diligence early to avoid supplemental
filings or RCE that decrease PTA
● E.g., Inventor publications; rejections in related
cases
● Meeting notes from inventors & employee coworkers of inventor? (Monsanto v Bayer)
● Details of testing to distinguish prior art
(Aventis v Amphastar)
● Filing RCE eliminates Type B (Post 3-year) PTA
8
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