Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala
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Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala

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Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala

Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala

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  • 1. Biotechnology and IP By Dr. Kalyan Kankanala Blog: www.bananaip.com/sinapse-blog
  • 2. US Patent Law and Biotechnology
  • 3. Overview • Article 1 Section 1 Clause 8 • Quid Pro Quo • Incentives • Title 35 • www.uspto.gov • www.fedcir.gov
  • 4. Patentability requirements • Patentable subject matter • Utility • Novelty • Nonobviousness • Specification
  • 5. INVENTIONS Subject Matter Usefulness Novelty Non-obviousness Specification PATENTS Kalyan’s Patent Filter Model
  • 6. Patentable Subject Matter • Section 101 - Process, machine, manufacture, composition of matter and Improvements • Funk Bros. v. Kalo • Diamond v. Chakrabarty • Pioneer Hibebred v. J.E.M. Arguments and Issues
  • 7. Funk Bros • Rhizobium bacteria • Innoculum of mutually inhibiting bacteria • Is it a product of nature?
  • 8. Chakrabarty's case • Psuedomonas bacteria • Four different plasmids inserted. • Is it a product of Nature?
  • 9. Utility • Current • Substantial • Credible • Brenner v. Manson • Gene/protein sequences
  • 10. Novelty • Section 102 • Known or used • Patented or published • Public use or On sale • Abandoned • Foreign Priority • Patented in another country
  • 11. Novelty • Derived • Suppressed or Concealed • Diligence • Single prior art reference • Isolated or purified- activity • Hybritech v. Monoclonal
  • 12. Nonobviousness • Scope of prior art • Differences- invention and prior art • Level of ordinary skill • Secondary Indicia • At the time of conception • Obvious to try
  • 13. Hybritech v. Monoclonal • immunometric assays using monoclonal antibodies
  • 14. Prior Art • a. Kohler and Milstein's Nobel Prize-Winning Work for Producing Monoclonal antibodies in vitro; • b. The Work of Drs. Oi and Herzenberg, in which they used monoclonal antibodies to "map" epitopes or determine the number and location of different antibody binding sites on a known quantity of IgE antigen by attaching to it an antibody bound to a carrier and exposing that antigen to other monoclonal antibodies; • c. The Frankel Article that disclosed Monoclonal Antibodies Having Affinities of 109 liters/mole; and • d. Articles "Predicting" Widespread Use of Monoclonal antibodies.
  • 15. In re Deuel: • Isolated and purified DNA and cDNA sequences encoding heparin-binding growth factors ("HBGFs")
  • 16. Prior Art • Bohlen's patent application disclosed a group of protein growth factors designated as heparin-binding brain mitogens ("HBBMs") useful in treating burns and promoting the formation, maintenance, and repair of tissue, particularly neural tissue. Bohlen determined the first 19 amino acids of the proteins' N- terminal sequences, which were found to be identical for human and bovine HBBMs. He provided no teachings concerning DNA or cDNA coding for HBBMs in his application.
  • 17. Prior Art • Maniatis described a method of isolating DNAs or cDNAs by screening a DNA or cDNA library with a gene probe. The reference outlined a general technique for cloning a gene but did not describe how to isolate a particular DNA or cDNA molecule.
  • 18. Recent Developments • KSR Vs. Teleflex • In re Kubin
  • 19. Specification • Written Description • Enablement • Best Mode • Claims • Object: Notice and Dissemination
  • 20. Example • A stent coated with taxol for "treating or preventing recurrent stenosis. • Prior ArtStents Existing • Taxol known for Tumor treatment by angiogenesis • Article - Re-stenosis dangers and need for a treatment - suggests various options
  • 21. Have a nice day For more information: www.bananaip.com www.bananaip.com/sinapse-blog Email: contact@bananaip.com