Bioinformatics Practice Considerations

1. Bioinformatics Practice Considerations October 20, 2011 Ling Zhong, Ph.D. lzhong@ratnerprestia.com

2. Bioinformatics • Use of computational methods and biological data to solve problems in the field of biology • Storage, retrieval and analysis of biological data • Challenges • Overlap of biotechnology and computer technology • One of ordinary skill in the art

3. Inventions • Computer-implemented methods • Biological molecules (e.g., genes, proteins, metabolites) or chemical compounds • Uses of biological molecules or chemical compounds

4. Examination • § 101: eligible subject matter (threshold test) • § 112 • ¶ 1: written description • ¶ 1: enablement • ¶ 2: definiteness • ¶ 6: means-plus-function • § 102: anticipation • § 103: obviousness

5. § 101 - Composition • Biotechnology invention • Isolated biological molecules eligible (Myriad) • Computer-related invention (MPEP 2106.01) • Descriptive material per se (e.g., database) ineligible • Functional descriptive material (e.g., database plus computer programs) eligible when claimed in combination with computer readable media • Nonfunctional descriptive material recorded on computer readable media ineligible • Transitory computer-readable media per se ineligible

6. § 101 - Process • Prometheus and Classen • Transformative steps (e.g., administering, determining, growing) not insignificant • RCT – eligible • “Inventions with specific applications or improvements to technologies in the marketplace are not likely to be so abstract that they override the statutory language [of § 101] and framework of the Patent Act”

7. § 101 - Process • Ultramercial – eligible • Application of a mere idea of advertising with many intricate and complex computer programming steps • CyberSource – ineligible • A computer-implemented method is ineligible if one could perform the method mentally without a computer • A computer readable medium containing program instructions for a computer to perform a method is ineligible if the computer-implemented method could be performed entirely in a human mind

8. § 112 , ¶ 1 • Computer-implemented functional claim limitation • Written description • All claims • Sufficiently identifying how the invention achieves the claimed function • Enablement • Full scope of computer-implemented functional claim limitation

9. § 112, ¶ 6 • Computer-implemented means-plus-function (MPF) limitation(Aoyama) • The corresponding structure must include an algorithm to transform a general purpose computer or microprocessor. • The specification must sufficiently disclose the algorithm. • A rejection under §112, ¶ 2 is appropriate if • No disclosure of the corresponding algorithm • No detail about the means to accomplish the software function • Merely referencing a specialized computer

10. §§ 102, 103 • Computer-implemented functional claim limitation • Broadest reasonable interpretation - anticipation • Implementing a known function on a computer - obvious • Adapting an existing process to incorporate internet and web browser technologies for communicating and displaying information - obvious • Functional descriptive material – claim limitation • Nonfunctional descriptive material – not claim limitation • Mere data (e.g., gene sequence) difference does not alter an actual process step.

11. Exemplary claims • Process/method • System/apparatus • Computer program product (i.e., software) • Biological molecules or chemical compounds • Uses of biological molecules or chemical compounds

12. Takeaway • Eligible subject matter • Machine-or-transformation test • Specific applications of an abstract idea or law of nature without preempting the use thereof • Improvements to technologies in the marketplace • Ample disclosure covering biotechnology and computer aspects • Sequence rules • Means-plus-function

13. THANK YOU! Ling Zhong, Ph.D. Phone: 1-610-993-4237 Fax: 1-610-993-0701 lzhong@ratnerprestia.com