Download Bioinformatics and 35 U.S.C. 101

TC 1600
Subject Matter Eligibility Under
35 USC § 101
Andrew Wang
SPE 1631
(571) 272-0811
1
Introduction of Interim
Guidelines
• Posted on USPTO web site 10/26/2005
• Published in the Official Gazette
11/22/2005
http://www.uspto.gov/web/offices/com/sol/og/2005/week47/patgupa.htm
2
Application of Guidelines
• Any position taken on 35 USC § 101 is based on
the substantive law, not the guidelines themselves
• The interim guidelines do not constitute
substantive rulemaking and do not have the effect
of law
• The interim guidelines set forth the procedures
USPTO personnel will follow when examining
applications
3
Prerequisite to Analysis Under
35 USC § 101
•
•
•
•
Determine what applicant invented
Review the specification and claims
Conduct a thorough search of the art
Identify and understand:
– any utility and/or practical application asserted by
applicant
– the meaning of claim terms
– claim scope
4
Improper Tests for Subject Matter
Eligibility
Tests that are not to be applied
• “not in the technological arts” test
• Freeman-Walter-Abele test
• Mental step or human step tests
• The machine implemented test
• The per se data transformation test
5
Analysis Under 35 USC § 101
1) Does the claimed invention fall within one of the
four statutory categories?
6
1) Statutory Categories
35 USC § 101 reads:
“whoever invents or discovers any new and useful
process, machine, manufacture, or composition, or
any new and useful improvement thereof, may
obtain a patent therefore, subject to the conditions
and requirements of this title.”
7
Enumerated Categories
• A “machine’, “manufacture”, and “composition of
matter” all define things and products.
• A “process” defines actions (i.e. inventions) that
set forth a series of steps or acts to be performed.
8
Examples Outside of the
Statutory Categories
1)
2)
3)
4)
5)
Literary Works per se
Rules to play a game per se
Legal agreements, e.g. an insurance policy
Signals per se
A computer program, logic, or language per se
9
If Not, Do Not Stop
• If a claim does not fall into a statutory category,
that does not preclude complete examination for
all other conditions of patentability
• The examiner must continue with the analysis
under 35 USC § 101 and still examine the claims
for compliance with 102, 103, and 112.
10
Analysis Under 35 USC § 101
1) Does the claimed invention fall within one of the
four statutory categories?
2) Does the claimed invention fall within a judicial
exception?
11
2) Judicial Exceptions
• The Supreme Court has specifically
identified three categories of non-statutory
subject matter
– Laws of Nature per se
– Natural Phenomena per se
– Abstract Ideas per se
12
Examples of Judicial Exceptions
• Laws of nature
E=mc2; F=ma; V=IR
• Natural Phenomena
The heat of the sun; electricity; a new mineral
• Abstract Ideas
Mathematical algorithms; legal rights
13
If Yes, Do Not Stop
• While judicial exceptions per se are not patent
eligible, methods and products employing abstract
ideas, natural phenomena, and laws of nature to
perform a real-world function may well be
• The scope of a claim must be ascertained to
determine if it covers a Sec. 101 judicial exception
or practical application of a Sec. 101 judicial
exception
14
Analysis Under 35 USC § 101
1) Does the claimed invention fall within one of the
four statutory categories?
2) Does the claimed invention fall within a judicial
exception?
3) Does the claimed invention provide a practical
application?
15
3) Practical Applications
• If the claim is directed to a practical
application of the Sec. 101 judicial
exception producing a result tied to the
physical world that does not preempt the
judicial exception, then the claim meets the
statutory requirement
16
Physical Transformation
• Does the claimed invention transform an
article or physical object to a different state?
• Transformation of data is not considered a
physical transformation
• Physical acts are not necessarily a physical
transformation
17
Determination of a Useful,
Concrete, and Tangible Result
• If the examiner does not find such a physical
transformation, the examiner must determine whether the
claim provides a practical application that produces a
useful, concrete, and tangible result
• A useful concrete, and tangible result must either be
specifically recited in the claim or inherently flow
therefrom
• A practical application is provided when a judicial
exception is applied, as claimed, to produce a useful,
concrete, and tangible result
18
Useful Result
• The claimed invention as a whole must
satisfy the utility requirement of 35 USC §
101: specific, substantial, and credible
• These criteria require an evaluation of the
specification and the knowledge of one of
ordinary skill in the art
19
Concrete Result
• Generally, a claimed invention is not
concrete when a result cannot be assured or
is not reproducible
• Concrete is not a requirement that the result
must be 100% accurate (e.g.: a claim
directed to a method of estimating,
predicting, or approximating)
20
Tangible Result
• A tangible result is a real world result
• The opposite meaning of “tangible” is “abstract”
(e.g.: thoughts and ideas are not real world results)
• The tangible result requirement does not
necessarily mean that a claim must be tied to a
particular machine or apparatus or must operate to
change articles or materials to a different state (i.e.
it is not a duplicate of physical transformation)
21
Computer Related Products
• Computer-related products such as
software, data structures, and collections of
data are also evaluated for a practical
application
• Computer-related products are classified in
one of two groups:
– Functional Descriptive Material
– Non-Functional Descriptive Material
22
Functional Descriptive Material
• “Functional Descriptive Material” includes data
structures and computer programs which impart
functionality when employed as a computer
component
• The definition of “data structure” is “a physical or
logical relationship among data elements,
designed to support specific data manipulation
functions.”
[see The New IEEE Standard Dictionary of Electrical and
Electronics Terms 308 (5th ed. 1993)]
23
Functional Descriptive Material
• Functional descriptive Material per se is not
statutory
• Functional Descriptive Material in combination
with an appropriate computer readable medium
must be capable of producing a useful, concrete,
and tangible result when used in conjunction with
a computer system
– the “computer readable medium” must be a physical
structure, not a signal, which permits the functionality
to be realized with the computer
24
Non-Functional Descriptive
Material
• Non-Functional Descriptive Material per se is an
abstract idea and therefore non-statutory
• Non-Functional Descriptive Material is not
statutory even in combination with a computer or
physical medium (e.g.: experimental data stored in
computer memory)
– no useful, concrete, or tangible result is produced
– no functionality is imparted to a computer (i.e. it is not
a computer component)
25
Examples of Non-Functional
Descriptive Material
•
•
•
•
•
Music
Literature
Art
Photographs
Data formats, frames, or
packets
• A data base per se
• Mere arrangements of
facts or compilations of
data
• Share price on a disk
Even when non-functional descriptive material is stored on,
read by, or outputted to a computer without any physical
interrelationship, they do not impart functionality to the computer
26
Analysis Under 35 USC § 101
1) Does the claimed invention fall within one of the
four statutory categories?
2) Does the claimed invention fall within a judicial
exception?
3) Does the claimed invention provide a practical
application?
4) Does the claimed invention preempt a judicial
exception?
27
4) Preemption
• A claim may not preempt every “substantial
practical application” of an abstract idea, law of
nature, or natural phenomena because it would in
practical effect be a patent on the judicial
exceptions themselves
• In order to establish a case of preemption, the
examiner must identify the abstraction, law of
nature, or natural phenomenon and explain why
the claim covers every practical application
thereof
28
Example 1
Claim 1 (original). A computer program comprising:
(i) first instructions for causing a computer executing said
instructions to read gene expression data from memory;
(ii) second instructions for causing said computer to analyze
said gene expression data and identify genes with catalytic
enzymatic activity; and
(iii) third instructions for causing said computer to transmit
said identified genes with catalytic enzymatic activity to a
user.
29
Example 1 (cont.)
Claim 1 (currently amended). A computer memory comprising
a program, wherein said program further comprises[[ing]]:
(i) first instructions for causing a computer executing said
instructions to read gene expression data from memory;
(ii) second instructions for causing said computer to analyze
said gene expression data and identify genes with catalytic
enzymatic activity; and
(iii) third instructions for causing said computer to transmit
said identified genes with catalytic enzymatic activity to a
user.
30
Example 1 (cont.)
Claim 1 (currently amended). A computer memory comprising
executable code for a program, wherein said program further
comprises:
(i) first instructions for causing a computer executing said
instructions to read gene expression data from memory;
(ii) second instructions for causing said computer to analyze
said gene expression data and identify genes with catalytic
enzymatic activity; and
(iii) third instructions for causing said computer to transmit
said identified genes with catalytic enzymatic activity to a
user.
31
Example 1 (cont.)
Claim 1 (currently amended). A computer memory comprising
executable code for a program, wherein said program further
comprises:
(i) first instructions for causing a computer executing said
instructions to read gene expression data from memory;
(ii) second instructions for causing said computer to analyze
said gene expression data and identify genes with catalytic
enzymatic activity; and
(iii) third instructions for causing said computer to transmit
said identified genes with catalytic enzymatic activity to a
user and further displaying said identified genes on a
computer screen.
32
Example 2
Disclosure: The purpose of the invention is to provide a method for
inserting a medical instrument at an optimal location in a human body
for the purpose of deploying the instrument during a surgical
procedure using the instrument.
Claim 1 (original). A method of determining an optimal location for
insertion of a medical instrument into a human body comprising:
i) determining a treatment site within a human body;
ii) selecting an instrument for use in treating the body at the treatment
site;
iii) determining the size and type of instrument; and
iv) determining an optimal location for insertion of the instrument
using an algorithm based on the size and type of the instrument and the
treatment site.
33
Example 2 (cont.)
Claim 1 (currently amended). A method of determining an optimal
location for insertion of a medical instrument into a human body
comprising:
i) determining a treatment site within a human body;
ii) selecting an instrument for use in treating the body at the treatment
site;
iii) determining the size and type of instrument; [[and]]
iv) determining an optimal location for insertion of the instrument
using an algorithm based on the size and type of the instrument and the
treatment site; and
v) inserting the instrument at the determined optimal location.
34
Example 3
Claim 1: The relationship between energy and mass
as represented by the equation E=mc2.
35
Example 3 (cont.)
Claim 1: A method of determining [[T]]the [[relationship
between]] energy associated with the [[and]]mass [[as
represented by]]of an object comprising:
(i) determining the mass of said object; and
(ii) determining the energy E of said object using the
equation E=mc2, wherein m is the determined mass of said
object.
36
Example 3 (cont.)
Claim 1: A method of determining the energy associated with
the mass of [[an object]]a spaceship comprising:
(i) determining the mass of said spaceship[[object]]; and
(ii) determining the energy, E, of said spaceship[[object]]
using the equation E=mc2, wherein m is the determined
mass of said spaceship[[object]].
37
Example 3 (cont.)
Claim 1: A method of determining the energy associated with
the mass of a spaceship comprising:
(i) determining the mass of said spaceship; [[and]]
(ii) determining the energy, E, of said spaceship using the
equation E=mc2, wherein m is the determined mass of said
spaceship; and
(iii) displaying the determined energy to a passenger on
said spaceship.
38
Acknowledgement
Special thanks is extended to
Eric DeJong for his contributions to the
preparation of this presentation.
39