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Biotechnology Enablement And Written Description 28 Sep10
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Biotechnology Enablement And Written Description 28 Sep10

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  • A "continuation-in-part" ("CIP") application can be filed to add new information to an existing application. CIP’s “are entitled to claim priority back to the original application, but only for patent claims that arise out of the existing material, not claims based on the material added in the CIP.” (Lemley and Moore)
  • SKB filing falls between 3 rd (21-Jun-1989) and 4 th (after 27-Jun-1990) Rasmusson applications.
  • Gormley 1991 - “concept that androgen-dependent prostate cancer dependent on DHT and not testosterone has yet to be definitively established.” Presti 1992 – “whether prostatic cancer cells are dependent upon DHT rather than testosterone is not well defined.” Gittes 1994 – reported successful treatment of prostate cancer with finasteride (NOW ENABLED). When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked. WD description not ruled on due to finding on enablement.
  • When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked. WD description not ruled on due to finding on enablement.
  • Chiron Discloses 08Feb84 Discloses one murine monoclonal Ab (454C11) that binds to c-erbB-2 (aka Her-2) Does not disclose chimeric Ab because pre-dates first pub. by 4 mos Does not disclose humanized Ab because pre-dates first pub. by 2 yrs 11Feb85, CIP of ’84 app. Discloses six addn’l murine monoclonal Abs that bind to c-erbB-2 Does not disclose chimeric or humanized Ab technology 21May86, CIP of ’85 app. Discloses six addn’l murine monoclonal Abs that bind to c-erbB-2 Does not disclose chimeric or humanized Ab technology 07Jun95, CIP of ’86 app., issues as ‘561 patent Discloses description of chimeric and humanized Ab technology Chiron Claims (‘561 Patent) “ A monoclonal antibody that binds to human c-erbB-2 antigen.”
  • What outcome if Chiron had pursued claims to “monoclonal antibodies that binds to human c-erbB-2 antigen” in each of the three priority applications? 1984? Chimeric Ab technology not yet developed Humanized Ab technology not yet developed 1985? Chimeric Ab technology developed Humanized Ab technology not yet developed 1986? Chimeric Ab technology developed Humanized Ab technology developed When should compliance with § 112, first paragraph be assessed? On the filing date of the parent application? On the filing date of the later filed continuation/CIP? What if Chiron had filed a series of file wrapper continuations (FWCs), Continued Prosecution Applications (CPAs), or Requests for Continuing Examination (RCEs) instead of CIPs?
  • What outcome if Chiron had pursued claims to “monoclonal antibodies that binds to human c-erbB-2 antigen” in each of the three priority applications? 1984? Chimeric Ab technology not yet developed Humanized Ab technology not yet developed 1985? Chimeric Ab technology developed Humanized Ab technology not yet developed 1986? Chimeric Ab technology developed Humanized Ab technology developed When should compliance with § 112, first paragraph be assessed? On the filing date of the parent application? On the filing date of the later filed continuation/CIP? What if Chiron had filed a series of file wrapper continuations (FWCs), Continued Prosecution Applications (CPAs), or Requests for Continuing Examination (RCEs) instead of CIPs?
  • What about continuations? Would Chiron have come out differently if the subsequent applications were continuations, not CIP’s? The court is silent. No suggestion that the analysis would be different for continuations.
  • Lemely and Moore, Ending Abuse of Patent Continuations, 84 B.U.L. Rev. 63 (2004).