Eduardo Quinones, Ph.D., Esq.
Amy A. Dobbelaere, Ph.D.
WHAT IS A PATENT?
• A patent is a property right
– Prevents others from making, using or selling your
invention without your permission
– Exclusionary Right
– One Patent – One Jurisdiction
TYPES OF PATENTS
For today, we will focus on Utility Patents
TYPES OF UTILITY APPLICATIONS
In the United States
– Provisional Applications
– Non-provisional Applications
Around the world
– Patent Cooperation Treaty (PCT) Application and
National Stage Filings
– Direct National Filings
– File first application before your first public
– File subsequent applications around the world within
a year or country-specific deadlines for PCT.
SO WHAT CAN I PATENT?
35 U.S.C. 101:
Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of
matter, or any new and useful improvement thereof,
may obtain a patent therefore, subject to the
conditions and requirements of this title.
Inventions must be new, useful, and non-obvious
Around the world:
New, involve an inventive step (~non-obvious), and
have industrial applicability (~useful)
TYPES OF INVENTIONS
– Mechanical, Electrical, Chemical, Software or
– Usually protecting:
• Devices/systems or components thereof
• Methods of operation, use, or manufacture
– Molecular biology, Gene therapy, Virology,
Genetics, Immunology, Stem cell technology, etc.
– Usually protecting:
• Compositions, methods of making & using
• Diagnostic kits/methods
• Transgenic organisms
PATENT APPLICATION PROCESS
• Prepare invention disclosure or other materials to
share with patent professional
• Patent professional prepares application*
• Application is filed
• Patent is Issued!
• Total time – Several years
PATENTABILITY REQUIREMENTS IN THE U.S.
• In the U.S., application will generally be examined to
ensure compliance with:
– 35 U.S.C. 101 – Something that can be patented?
– 35 U.S.C. 102 – Is it new in view of the prior art?
– 35 U.S.C. 103 – Is it non-obvious in view of the prior
– 35 U.S.C. 112 – Does the application have
• (1) An adequate description of the invention?
• (2) Enough details to practice the invention?
PATENTABILITY REQUIREMENTS IN THE U.S. (Cont’d)
• Most Engineering-type inventions
– Typically straightforward to describe and claim in
– Examination typically limited to claim form in view
of prior art
• However, certain types of inventions require
– Biotech inventions
– Software inventions
CONSIDERATIONS FOR BIOTECH
TYPICAL BIOTECH PATENT APPLICATION/PATENT
• Description and Figures
― As detailed a description as possible, including
examples of several embodiments for a given
― In the ‘Examples’ section, inclusion of all relevant
data, in vivo data always preferred
― Data figures
― Composition consisting of or comprising…
― Method of treating disease X in a subject
comprising administering the composition…
― Method of making a composition comprising…,
the method comprising the steps of: a, b and c
― Method for analyzing X in a sample…
― A kit for analyzing X or treating disease X…
BIOTECH PATENTS AROUND THE WORLD
• In EPO, plant & animal varieties & biological
processes for production thereof, methods for
treatment of the human or animal body by surgery or
therapy & diagnostic methods practiced on the
human or animal body not patentable
• In EPO, patenting of stem cells is controversial – EPO
does not process stem cell applications while the UK
& DE patent offices follow a less stringent approach
• In JPO, methods to treat humans, specifically through
surgery, general treatment, or diagnosis are not
• In Canada, methods of medical treatment & higher
life forms are not patentable
BIOTECH PATENTS AROUND THE WORLD (cont.)
• U.S. patent rules provide applicants with relatively
flexible rules for amending claims during patent
• EP in particular has more stringent claim support
requirements – EP examiners typically don’t allow
cobbling together an amended claim out of
different embodiments. In EP, providing numerous
embodiments of a given invention is a necessity, &
describing how to combine various features of the
disclosed embodiments may also be.
• China and Australia moving in EP’s direction
• JPO strictly requires that patent applications claiming
medical uses (pharmaceutical inventions) should
disclose "pharmacological test data or the
equivalent" in the specification.
BIOTECH PATENTS IN THE U.S.
• The USPTO considers non-naturally occurring, nonhuman multicellular organisms, including animals, to
be patentable subject matter
― Microorganisms (bacteria, yeast, fungi)
― Embryonic stem cells
― Cellular / Biological Processes
― Genes and Nucleotide Sequences
― Gene Products (proteins)
― Biologically Derived Chemicals / Pharmaceuticals
― Diagnostic reagents
― Methods of treatment
― Medical Devices
BIOTECH PATENTS IN THE U.S. (cont.)
• Recent Case Law/Issues
― 2012 - Mayo Collaborative Services v. Prometheus
― 2013 – Ass’n for Molecular Pathology v. Myriad
― 2014 – AbbVie v. Janssen Biotech and Centocor
― Higher enablement (35 U.S.C. 112) standard
compared to other fields
― Experimental data very important in many cases, in
vivo more compelling than in vitro, e.g., claims for
‘method of preventing…’ & vaccines require
substantial in vivo data for support
CONSIDERATIONS FOR SOFTWARE
• Generally two main aspects for any type of software:
– Algorithms, methods, and other general concepts
that describe, at a high level, how the software
– Actual computer code for implementing these
• Patents - Target the high level concepts
• Other types of protection are typically used for
computer code (e.g., Copyright)
TYPICAL SOFTWARE-BASED PATENT
• Description and Drawings:
– Operating Environment
– Particular/specialized components
– Flow charts for each process
– General Computer description/schematic
– Computer-Product Claims
– System Claims
EXAMPLE OF SOFTWARE PATENT
SOFTWARE PATENTS AROUND THE WORLD
Outside the U.S., obtaining software-based patents can be
– Excluded by law; or
– Excluded by problem/solution examination
Problem/Solution Examination requires determining:
– Problem being solved A technical one?;
– Solution being claimed:
• Would it be obvious to adapt the closest prior art to
provide the solution?
• Does solution provides a technical effect or advantage
over the closest prior art.*
Thus, completely new software methods may be unpatentable
overseas unless one can demonstrate a tangible, technical
advantage of the method or system implementing the method.
SOFTWARE PATENTS IN THE U.S.
• Patents can be obtained for software-based
inventions in the U.S.
– Software per se is not patentable in the U.S.
– However, methods implementing software-based
inventions or articles of manufacture
implementing such methods may be patentable
• To a major extent, examination is straight forward
• However, recent developments have imposed
MAIN ISSUE - IS A SOFTWARE-BASED INVENTION
ELIGIBLE FOR PATENT PROTECTION?
• 35 U.S.C. 101: Whoever invents or discovers any new
and useful process, machine, manufacture, or
composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this
• Pre-2010 – Machine or Transformation (MT) Test
• 2010 - Bilski V. Kappos – MT test not sole measure of
• 2014 - Alice v. CLS - Claims directed to an abstract
idea or a generic computer implementation of an
abstract idea are ineligible for patent protection
SOFTWARE-BASED PATENTS AFTER ALICE V. CLS?
USPTO Examination (still developing)
(1) Is the claim directed to an abstract idea?
(2) If so, are there other claim features that show a
patent-eligible application of the abstract idea, e.g.,
more than a mere instruction to apply the abstract
What does this mean?
– Does the claim recite a way to use the abstract idea
solve a technical problem?; or
– Does the abstract idea provide some type of
In sum a problem/solution or technical step type
approach to determine patent eligibility
– No clear guidance yet, but consistent with Post-Alice
SO WHAT DO YOU NEED TO DO?
– Don’t limit description to just the software and how it
– Describe, in detail, technical problems solved by the
software or a system implementing the software
– Describe, in detail, any technical advantages of
using the software
• e.g., improved computational speed, reduced
memory demands, not just a business
Working with patent professionals
– Read draft applications in their entirety (you are
supposed to do so anyways!) and make sure
technical advantages and/or technical problems
solved by the software are discussed as fully as
Eduardo Quinones, Ph.D., Esq.
Amy A. Dobbelaere, Ph.D.
Novak Druce Connolly Bove + Quigg LLP
Cityplace Tower, 15th Floor
525 Okeechobee Blvd
West Palm Beach, FL 33401