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

2. 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. 3 Inventions Computer-implemented methods Biological molecules (e.g., genes, proteins, metabolites) or chemical compounds Uses of biological molecules or chemical compounds

4. 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. 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. 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. 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. 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. 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. 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. 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. 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. 13 THANK YOU! Ling Zhong, Ph.D. Phone: 1-610-993-4237 Fax: 1-610-993-0701 lzhong@ratnerprestia.com