Intelligent Bio-Systems, Inc. v. Illumina Cambridge Limited, Final Written Decision IPR2013-00128
Thursday, July 31, 2014

Takeaway: In the case where Patent Owner files a non-contingent Motion to Amend requesting the cancellation of all of the challenged claims (i.e., the cancellation request is not contingent on the original claims being determined unpatentable) and the addition of new claims in their place, the Board may deny in part the Motion to Amend to the extent it seeks to add the substitute claims and grant in part the Motion to Amend to the extent it seeks to cancel the originally challenged claims.

In its Final Written Decision, the Board denied in part Patent Owner’s Motion to Amend, to the extent it sought to add substitute claims 9-12, and granted in part Patent Owner’s Motion to Amend, to the extent it sought to cancel claims 1-8.  The effect of the Board’s Final Written Decision was that all claims of the ’026 Patent were held to be unpatentable.  Also, the Board dismissed Patent Owner’s Motion to Exclude Evidence as moot, denied in part Petitioner’s Motion to Exclude Evidence with respect to Exhibits 2039 and 2040, and dismissed in part Petitioner’s Motion to Exclude Evidence as moot with respect to Exhibits 2029, 2030, 2032, 2033, 2035, 2036, and 2042.

Petitioner had challenged the patentability of claims 1-8 of the ’026 Patent.  The Board instituted inter partes review of each of these claims based on five grounds of unpatentability, including anticipation grounds as applied to claims 1-6 and obviousness grounds as applied to claims 7 and 8.  The ’026 Patent relates to labeled nucleotides and nuncleosides as used in various reactions and techniques.

Patent Owner then filed a non-contingent Motion to Amend in which the cancellation of claims 1-8 was requested (i.e., the cancellation request was not contingent on the original claims being determined unpatentable) and in which substitute claims 9-12 were proposed to replace the cancelled claims.  Along with this, Patent Owner asserted that “each of the grounds upon which the inter partes review was instituted ‘is rendered moot in light of [Patent Owner’s] proposed substitute claims.’”  In its Motion to Amend, Patent Owner had proposed to substitute new claim 9 for original claim 1, with the “contains a disulfide linkage” limitation in claim 9 not having been recited previously in any of the challenged claims.  According to the Board, the  “obviousness of using a disulfide linkage is the main issue to be decided in whether to grant the Motion to Amend.”

The Board proceeded to perform a claim construction analysis with respect to certain recited terms.  In connection with this analysis, the Board indicated that “disulfide linkage is a bond between two sulfur atoms.”  The Board then noted that because Patent Owner has the burden of proving that its Motion to Amend should be granted, Patent Owner must show that the subject matter recited in proposed claim 9, particularly use of a cleavable disulfide linker to attach a label to the nucleotide base, where the linker and protecting group of the nucleotide are cleaved under identical conditions, would not have been obvious.

The Board found that Patent Owner had not met its burden in showing that the proposed substitute claims 9-12 were patentable over the prior art of record.  As stated by the Board, “[t]he record contains numerous publications that utilize a disulfide bond linker to join a label to a nucleotide base.”  Moreover, the Board was not convinced by the objective evidence of obviousness that Patent Owner had presented in attempting to show unexpected, improved results.  Thus, the Board denied Patent Owner’s Motion to Amend to the extent it was requesting entry of proposed substitute claims 9-12.

As mentioned, both parties had filed Motions to Exclude Evidence.  The Board dismissed as moot Patent Owner’s Motion to Exclude, and dismissed in part as moot Petitioner’s Motion to Exclude, because the Board had not relied on the subject matter sought to be excluded in reaching its final conclusions.  The Board denied in part Petitioner’s Motion to Exclude because Petitioner had not explained sufficiently why the documents sought to be excluded lacked foundation.

Intelligent Bio-Systems, Inc. v. Illumina Cambridge Limited, IPR2013-00128 
Paper 92: Final Written Decision
Dated: July 25, 2014
Patent 7,057,026 B2 
Before: Lora M. Green, Richard M. Lebovitz, and Christopher L. Crumbley 
Written by: Lebovitz
Related Proceeding: Trustees of Columbia University in the City of New York v. Illumina, Inc., 1:12-cv-00376-GMS (D. Del.)

 

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