Transcript the claims

INTELLECTUAL PROPERTY PROTECTION
WPI Presentation
March 27, 2007
Presenters:
Jacob N. (Jesse) Erlich, Esq.
Dr. Orlando Lopez, Esq.
Dr. Janine M. Susan, Esq.
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www.burnslev.com
Understanding Intellectual Property
INTELLECTUAL PROPERTY
• Formal definition
• Intellectual property is an intangible or proprietary
asset such as a patent, copyright, trademark or
trade secret
• My definition
• Intellectual property is a protectable development
of the mind
EXAMPLES OF INTELLECTUAL
PROPERTY PROTECTION
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Trade secrets
Patents
Copyrights
Trademarks
TRADE SECRETS
• Used to protect important business information that a
business does not want to disclose to the public
• Effective only if kept confidential
• Do not release trade secrets without a nondisclosure
agreement
• Always place appropriate marking on trade secret
information (e.g., Proprietary Information, Not for Public
Release)
• Last indefinitely as long as they are kept secret
WHAT IS A U.S. PATENT
• Grant by the government to provide individuals with
legal protection for their discoveries (inventions)
• Article 1, Section 8, of the U.S. Constitution states
that Congress is empowered to "...promote the
progress of science and useful arts by securing for
limited times to authors and inventors the exclusive
right to their respective writings and discoveries"
• Covered by Federal law (Title 35 of U.S. Code)
TERM AND EXCLUSIONARY
RIGHT OF A UTILITY PATENT
• Patent applications filed after June 8, 1995—20 years
from effective filing date
• Patent applications actually filed before June 8, 1995
or patents in effect on June 8, 1995—The longer of
either 20 years from the effective filing date or 17
years from the issue date
• Patent owner given the right to prevent others from
making, using, offering for sale, selling, or importing
the claimed invention within the U.S.
TERM AND EXCLUSIONARY
RIGHT OF A UTILITY PATENT
• Process patent owners also given the right to
prevent others from importing a product
obtained from patented process
TYPES OF PATENTS
• Utility
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Process (method)
Machine
Article of manufacture
Composition of matter
Improvements on all of the above
• Plant
• Design
WHO IS ENTITLED TO A PATENT
• To obtain a patent, individual(s) must be
original and first inventor
• Invention must be conceived
• Invention must be reduced to practice (actual or
constructive)
• Must file a patent application
CONDITIONS FOR PATENTABILITY
• Invention must be:
• Novel
• Useful
• Non-obvious
• Statutory bars against obtaining patent set forth in 35
USC 102
• Examples
• Unrestricted printed publication more than 1 year prior to
filing patent application
• Public use or on sale in U.S. more than 1 year prior to filing
patent application
Provisional Patent Applications
Effect Of An Inadequate Provisional
Case
NEW RAILHEAD MANUFACTURING, L.L.C.,
Plaintiff-Appellant,
v.
VERMEER MANUFACTURING COMPANY,
Defendant-Appellee,
and
EARTH TOOL COMPANY, L.L.C.
FOREIGN PATENTS
• Patentability based on absolute novelty
• Applicant need not be inventor
• Filing of foreign applications
• Directly in foreign country
• Under regional patent systems
• Under Patent Cooperation Treaty (PCT)
FOREIGN PATENTS
• Foreign applications must be filed within 1
year of U.S. provisional/patent application
filing date to receive priority date
COPYRIGHTS
Provide individuals and companies with legal
protection for a wide variety of works of
“authorship”
• Pictorial, graphic and
sculptural
• Audiovisual
• Sound recording
• Computer databases
and software
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Literary
Musical
Dramatic
Pantomimes
Choreographic
COPYRIGHTS
• Copyright protection
• Occurs upon creation
• Lasts for the life of the author plus 70 years
• For “works for hire,” lasts 95 years from publication or 120
years from creation, whichever expires first
• Copyright registration
• Not required
• Beneficial when taking infringement action
• Copyright ownership resides with:
• Author
• Employer when work for hire
TRADEMARKS
• Provide protection for words or symbols or
combination used by manufacturer or merchant to
identify source of goods
• Become effective when used on goods in commerce
• Federal registration—interstate commerce
• State registration— intrastate commerce
• Protection lasts indefinitely
• If properly used
• If renewed
SERVICE MARKS
• Provide protection for words or symbols or
combination identifying services rendered by a
business
• Covered by trademark laws
• Become effective when used to advertise
service
• Use in commerce not required
TRADE NAMES
• Used to identify name under which an
organization does business
• Not federally registered
Understanding Claims of a Patent
Application
READING A PATENT APPLICATION
• Suggested approach
• Start with the claims (at the end of the application)
• Then compare the claims to the drawings
• Finally, read the entire application
• Or, you can follow the Mad Hatter advice
(start at the beginning)
THE CLAIMS
• The claims define the invention (they are
similar to the metes and bounds in the property
deed)
• If you describe an invention in the
specification (the narrative part of the patent
application) but do not cover that invention in
the claims, the patent does not protect that
invention
A System Claim
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A system claim
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A sensor calibration system comprising:
Preamble
1st Limitation
–
an image capture sub-system including a line sensor;
2nd Limitation
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an image generating sub-system capable of generating two dimensional image
data from said line sensor;
3rd Limitation
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a processing sub-system capable of analyzing the two dimensional image data
and generating calibration information; and,
4thLimitation
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an output sub-system capable of displaying results of said analysis; wherein the
results of said analysis are used to calibrate the line sensor.
Drawing corresponding to claim example
A method claim
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A method of calibrating a line sensor the
method comprising the steps of:
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generating a two dimensional image from the
line sensor
analyzing said two dimensional image
generating calibration information for
the line sensor based on the analysis in
order to calibrate the line sensor
Figure corresponding to the method
claim
How the patent is asserted (used to
exclude others)
• Each claim of the patent is compared to a
potentially infringing product
• A product must have all the limitations of a
claim in order to infringe the claim (make
claims with few limitations!! Less is more in
this case)
Protecting Chemical and
Biotechnology Inventions
Chemical Inventions
• Chemical Compound or Composition
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Structure
Name
Formula
Definitive chemical and physical properties
Utility
• Use of a chemical compound for general
research purposes is not sufficient
• Use of a compound as an intermediate in preparing
a known material was not sufficient utility when a
method of transforming the intermediate into the
final product was not known (Brenner v. Manson,
383 U.S. 519 (1966))
Written Description
• A broad generic claim directed to a large
number of chemical compounds has been held
not to be a written disclosure of each
compound encompassed within the generic
claim (In re Ruschig, 379 F.2d 990 (CCPA
1967)
• Include a lengthy list of compounds falling within
the scope of the generic claim
• Can be time-consuming and expensive
• May be possible to list the compounds not in the genus
Enablement
• How to make a chemical compound or composition
• Identify starting materials
• Describe how to make or obtain starting materials
• Reaction conditions
• Broad ranges/preferred ranges/alternative methods
• Working examples
• If possible should meet “scientific paper” standards
• Include e.g.: exact amounts of starting materials, order of addition
of reactants, reaction conditions, purification steps,
identification/characterization steps, equipment used
• Number of examples depends on scope of claims and predictability
(or lack thereof) of the chemistry
• Prospective examples can be included
Enablement
• How to use a chemical composition
• Include data in the working examples showing that
the compounds possess the stated utility
• All compounds claimed need not exhibit the same
degree of utility
Best Mode
• Failure to disclose the specific supplier and trade
name of the inventor’s preferred material violated the
“best mode” requirement (Chemcast Corp. v. Arco
Indus. Corp., 913 F.2d 923 (Fed. Cir. 1990)
• Claimed grommet was made from a polyvinyl chloride
plastisol, and the inventor did not know the formula,
composition, or method of manufacture of the plastisol
• Only one of several polyvinyl chloride plastisols tried by the
inventor was effective for obtaining his grommet
Claiming a Chemical Invention
• Compound of formula XRR’R”, wherein R is A, B, or C; R’ is D, E,
or F; R” is G or H
• Compound Y per se (i.e. X, wherein R is A; R’ is D; and R” is G)
• Compound XRR’R” in combination with desirable functional
properties (e.g. Compound XRR’R” which inhibits HIV infectivity)
• Methods of making compound XRR’R”
• Methods of using compound XRR’R”
• Compositions containing compound XRR’R” (e.g. A composition
comprising compound XRR’R” and a pharmaceutically acceptable
carrier)
• Kits containing a variety of reagents including compound XRR’R”
• Composition made by combining L, M, and N
Functional Expressions
• E.g.: Defining a radical on a chemical
compound as “incapable of forming a dye with
said oxidizing developing agent”
• Although functional, it set definite boundaries on
claim scope
• Claimed composition must still be novel and
not merely a known composition with an as yet
unknown property recited in the claims
Operability
• E.g.: A composition comprising a herbicidally
active compound of the formula X
• Does not include nonoperable compounds within
its scope, even if the generic formula X includes
such compounds
Biotechnology Inventions
• Typically involve the modification of an
existing system of living matter into elements
that may be difficult to define
• Often described in functional terms (e.g.,
describing the biological effects of the invention)
rather than the structural elements of the invention
• Claimed composition must still be novel and not merely
a known composition with an as yet unknown property
recited in the claims
Utility
• Use of a nucleic acid sequence as a probe to obtain
the full length gene is not sufficient
• General research purpose
• Method of treating X in humans comprising
administering Y
• Utility rejections because application only discloses results
obtained in vitro
• Use “art-recognized” model systems
• Utility can be shown if there is a “reasonable” correlation between
activity and asserted utility
• In vivo animal data, if possible
• Treatments need not be 100% effective (need not “cure” a disease)
• Drugs (“Y”) need not meet FDA standards of safety and efficacy
Novelty/Inherency
• Claimed invention is a metabolite resulting
from an administered drug
• Claim a substantially pure metabolite
• Claim metabolite as a part of a pharmaceutical
composition
• Claim a method of administering the metabolite
Obviousness
• A pharmaceutical composition comprising: an
effective amount of amlodipine and an
effective amount of a substantially pure form
of hydroxylated atorvastatin metabolite
• Unexpected results
• synergistically inhibit lipid peroxidation in human low
density lipoprotein or lipid membrane
Written Description
• Rapidly evolving “state of the art”
• “Experimental” and “unpredictable”
procedures becoming “standard” and “wellknown”
• E.g., depositing an antigen in a public depository
and claiming an antibody by its binding affinity to
the deposited antigen vs. providing the amino acid
and/or nucleotide sequence of an antibody
Biological Deposits
• Where words alone cannot sufficiently describe how
to make and use the invention, deposit of biomaterials
may be necessary (not a substitute for written
description)
• Cell lines
• Deposit before filing or during pendency of application
• Must be made for at least 30 years
• Depository recognized by the Budapest Treaty (e.g. ATCC)
Nucleotide and Amino Acid Sequence
Listings
• Requires use of standard symbols and a standard format
• Requires submission in a computer readable form
• 1996 guideline permitting examination of up to ten,
independent and distinct molecules described by their
nucleotide sequence in a single patent application has been
rescinded as of February 22, 2007
• Claims to polynucleotide molecules will be considered for
independence, relatedness, distinction and burden as for any other
molecule
• Unity of invention will exist when polynucleotide molecules share a
general inventive concept (i.e. share a technical feature which makes a
contribution over the prior art)
Claiming a Biotechnology Invention
• Proteins
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Purified or isolated protein
Protein coupled to another molecule
Processed forms of the protein
DNA encoding the protein (isolated, purified, in a vector)
Expression systems (i.e. DNA linked to control sequences
such as promoters)
• Recombinant host cells containing the encoding DNA or
expression system
• Method to produce the protein recombinantly
Claiming a Biotechnology Invention
• Proteins (cont’d.)
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Recombinant protein
Methods of treatment or diagnosis using the protein
Pharmaceutical compositions containing the protein
DNA encoding the protein conjugated to another molecule
Methods of using the DNA in diagnosis or as a probe
Antibodies reactive with the protein
Methods to purify the protein from native or recombinant
sources
• Methods to assay for the presence or activity of the protein
Some Claim Categories for
Biotechnology Inventions
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Proteins, polypeptides (fragments)
cDNA or recombinant DNA (fragments)
SNPs (diagnosis)
Monoclonal Antibodies (MAbs)
Engineered MAbs (e.g. Fabs, humanized antibodies)
Anti-sense RNAs, siRNAs
Recombinant vectors
Transformed cell lines
Stem cell lines
Transgenic animals
Methods of producing a protein, an antibody, a polynucleotide
Methods of using a protein, an antibody, a polynucleotide
Diagnostics (kits, methods/assays, DNA chips/microarrays)
Vaccines
Asexually-produced plants, genetically engineered plants