Biotechnology Enablement And Written Description 28 Sep10
•Download as PPT, PDF•
0 likes•253 views
![35 U.S.C. § 112, ¶ 1 Written Description, Enablement, and Best Mode ,[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
Recommended
Recommended
More Related Content
Viewers also liked
Viewers also liked (12)
Similar to Biotechnology Enablement And Written Description 28 Sep10
Similar to Biotechnology Enablement And Written Description 28 Sep10 (20)
More from Gary M. Myles, Ph.D.
More from Gary M. Myles, Ph.D. (6)
Biotechnology Enablement And Written Description 28 Sep10
- 1. Biotechnology Patent Prosecution – Part 2: Enablement and Written Description Seattle University School of Law Biotechnology and the Law Gary M. Myles, Ph.D. Schwabe, Williamson & Wyatt September 28, 2010
- 8. Degeneracy of the Genetic Code GGT Gly (G) GGC " GGA " GGG " GAT Asp (D) GAC " GAA Glu (E) GAG " GCT Ala (A) GCC " GCA " GCG " GTT Val (V) GTC " GTA " GTG " G AGT Ser (S) AGC " AGA Arg (R) AGG " AAT Asn (N) AAC " AAA Lys (K) AAG " ACT Thr (T) ACC " ACA " ACG " ATT Ile (I) ATC " ATA " ATG Met (M) A CGT Arg (R) CGC " CGA " CGG " CAT His (H) CAC " CAA Gln (Q) CAG " CCT Pro (P) CCC " CCA " CCG " CTT Leu (L) CTC " CTA " CTG " C TGT Cys (C) TGC TGA Ter TGG Trp (W) TAT Tyr (Y) TAC TAA Ter TAG Ter TCT Ser (S) TCC " TCA " TCG " TTT Phe (F) TTC " TTA Leu (L) TTG " T G A C T
- 12. Practice Tip Disclosure of Single Embodiments is Risky Claim Construction 35 U.S.C. § 112, ¶1 OK if construed reads on: · Your commercial product · Competitor’s commercial product “ Invalid”
- 13. Practice Tip Disclose Multiple Embodiments Claim Construction 35 U.S.C. § 112, ¶1 “ Not Invalid”
- 14. Practice Tip Draft Nested Claims from Broad to Narrow 1. Broad Independent Claim 2. Narrow Dependent Claim 3. Still Narrower Dependent Claim 4. Narrowest “Picture” Claim
- 45. Chiron v. Genentech (Fed. Cir. 2004) Feb. 1984 Parent App. Filed Discl. 1 MAb No Chimeric No Humanized May 1984 First Chimeric Antibody Publication 1985 CIP App. Filed Discl. 6 MAb No Chimeric No Humanized 1986 CIP App. Filed Discl. 6 MAb No Chimeric No Humanized 1995 CIP App. Filed Discl. 1 MAb Chimeric & Humanized Ab Technology May 1986 First Humanized Antibody Publication Intervening Art 1977 First Monoclonal Antibody Publication
- 48. Chiron v. Genentech (Fed. Cir. 2004) Feb. 1984 Parent App. Filed Discl. 1 MAb No Chimeric No Humanized (HELD: NO WD) May 1984 First Chimeric Antibody Publication 1985 CIP App. Filed Discl. 6 MAb No Chimeric No Humanized (HELD: NON-ENABLED) 1986 CIP App. Filed Discl. 6 MAb No Chimeric No Humanized (HELD: NON-ENABLED) 1995 CIP (‘561 Patent) App. Filed Discl. 1 MAb Chimeric & Humanized Ab Technology (HELD: ANTICIPATED) May 1986 First Humanized Antibody Publication Chiron sues Genentech For Infringement based on sale of Herceptin (Humanized Ab) Intervening Art 1977 First Monoclonal Antibody Publication
- 80. ICU v. Alanis (Fed. Cir. 2009)
- 81. Goeddel v. Sugano (Fed. Cir. 2010)
- 82. Laryngeal v. Avbin (Fed. Cir. 2010)
Editor's Notes
- 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).