[ w w w. d u a n e m o r r i s. c o m ] ● ©2008 Duane Morris LLP. All Rights Reserved. Duane Morris is a registered service mark of Duane Morris LLP. ● Duane Morris – Firm and Affiliate Offices | New York | London | Singapore | Los Angeles | Chicago | Houston | Hanoi | Philadelphia San Diego | San Francisco | Baltimore | Boston | Washington, D.C. | Las Vegas | Atlanta | Miami | Pittsburgh | Newark | Boca Raton Wilmington | Princeton | Lake Tahoe | Ho Chi Minh City | Duane Morris LLP – A Delaware limited liability partnership 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

● [ w w w. d u a n e m o r r i s. c o m ] The Patent Squeeze 112 Ariad v. Eli Lilly ICU Medical 103 KSR In re Kubin 102 In re Gleave In re Chuang

● [ w w w. d u a n e m o r r i s. c o m ] SCOPE: ENEMY OF TERM HELD NOT PATENTABLE (35 U.S.C. § 102) 3 CLAIMPRIOR ART DISCLOSURE “bispecific antisense oligodeoxynucleotide”... “of sufficient length to act as an antisense inhibitor” of IGFBP-2 and IGFBP-5” [claims now limited to [surprisingly] most active 20- mer) & modified forms] ● List of all 15-nucleotide sense oligos (>1400) ● States antisense oligos can interact with sense oligos, 15- mer to 25-mer, bispecific ● Knowledge of how to make oligos ● No understanding of which targets would be useful In re Gleave

● [ w w w. d u a n e m o r r i s. c o m ] SCOPE: ENEMY OF TERM HELD NOT PATENTABLE (35 U.S.C. § 102) 4 CLAIMPRIOR 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 In re Chuang (Bd.)

● [ w w w. d u a n e m o r r i s. c o m ] SCOPE: ENEMY OF TERM HELD NOT PATENTABLE (35 U.S.C. § 103) 5 CLAIMPRIOR ART DISCLOSURE “isolated nucleic acid molecule... encoding a polypeptide at least 80% identical to amino acids 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 1 st 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 2 nd ref: cloned mouse analog In re Kubin

● [ w w w. d u a n e m o r r i s. c o m ] SCOPE: ENEMY OF TERM : 35 U.S.C. § CLAIMLACK OF WRITTEN DESCRIPTION A method for... “reducing NF-κB activity” comprising “reducing binding of NF-κB to NF- κB 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] Ariad v Eli Lilly

● [ w w w. d u a n e m o r r i s. c o m ] SCOPE: ENEMY OF TERM : 35 U.S.C. § CLAIMLACK OF WRITTEN DESCRIPTION Claims to needleless connector valves comprising a body and a seal; claims omitted “spike” limitation present in all disclosed embodiments Draft embodiments with and without elements No description of “spikeless” valves covered by claims which do not recite a “spike” element. ICU Medical v. Alaris

● [ w w w. d u a n e m o r r i s. c o m ] 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 co- workers 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