Download AIPLA Bioinformatics Presentation 120611

Bioinformatics Practice
Considerations
December 6, 2011
Ling Zhong, Ph.D.
[email protected]
The contents of this presentation are those of the author and do not necessarily reflect
the views of the firm or its clients. This presentation is for general information purposes
and is not intended to be and should not be taken as legal advice.
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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
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Inventions
• Computer-implemented methods
• Biological molecules (e.g., genes,
proteins, metabolites) or chemical
compounds
• Uses of biological molecules or
chemical compounds
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Examination
• § 101: eligible subject matter (threshold test)
• § 112
¶ 1: written description
¶ 1: enablement
¶ 2: definiteness
¶ 6: means-plus-function
• § 102: anticipation
• § 103: obviousness
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§ 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
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§ 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”
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§ 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
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§ 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
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§ 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
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§§ 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.
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Exemplary claims
• Process/method
• System/apparatus
• Computer program product (i.e., software)
• Biological molecules or chemical
compounds
• Uses of biological molecules or chemical
compounds
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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
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THANK YOU!
Ling Zhong, Ph.D.
Phone: 1-610-993-4237
Fax: 1-610-993-0701
[email protected]
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