Biotechnology and IP

Kalyan www.kalyankankanala.com www.brainleague.com

US Patent Law and Biotechnology

Overview
Article 1 Section 1 Clause 8 Quid Pro Quo Incentives Title 35 www.uspto.gov www.fedcir.gov

Patentability requirements
Patentable subject matter Utility Novelty Nonobviousness Specification

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. Myriad Genetics case

Funk Bros

Rhizobium bacteria Innoculum of mutually inhibiting bacteria Is it a product of nature?

Chakrabarty's case
Psuedomonas bacteria Four different plasmids inserted. Is it a product of Nature?

Utility
Current Substantial Credible
Brenner v. Manson Gene/protein sequences

Novelty
Section 102 Known or used Patented or published Public use or On sale Abandoned Foreign Priority Patented in another country

Novelty
Derived Suppressed or Concealed Diligence Single prior art reference Isolated or purified- activity

Hybritech v. Monoclonal

Nonobviousness
Scope of prior art Differences- invention and prior art Level of ordinary skill Secondary Indicia

At the time of conception Obvious to try

Hybritech v. Monoclonal
immunometric assays using monoclonal antibodies

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.

In re Deuel:
Isolated and purified DNA and cDNA sequences encoding heparin-binding growth factors ("HBGFs")

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' Nterminal 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.

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.

Recent Developments
KSR Vs. Teleflex In re Kubin

Specification
Written Description Enablement Best Mode Claims

Object: Notice and Dissemination

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