What’s Patentable?Eduardo Quinones, Ph.D., Esq.Amy A. Dobbelaere, Ph.D.

• A patent is a property right– Prevents others from making, using or selling

your invention without your permission– Exclusionary Right – One Patent – One Jurisdiction

WHAT IS A PATENT?

Design PlantUtility

For today, we will focus on Utility Patents

TYPES OF PATENTS

• In the United States– Provisional Applications– Non-provisional Applications

• Around the world– Patent Cooperation Treaty (PCT) Application and

National Stage Filings– Direct National Filings

• Timing– File first application before your first public

disclosure*– File subsequent applications around the world

within a year or country-specific deadlines for PCT.

TYPES OF UTILITY APPLICATIONS

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)

SO WHAT CAN I PATENT?

• “Engineering”– Mechanical, Electrical, Chemical, Software or

combinations thereof– Usually protecting:

• Devices/systems or components thereof• Methods of operation, use, or manufacture

• Biotechnology Inventions

– Molecular biology, Gene therapy, Virology, Genetics, Immunology, Stem cell technology, etc.

– Usually protecting:• Compositions, methods of making & using• Diagnostic kits/methods• Transgenic organisms

TYPES OF INVENTIONS

• Prepare invention disclosure or other materials to share with patent professional

• Patent professional prepares application*– Specification/Description– Drawings– Claims

• Application is filed• Examination• Allowance • Patent is Issued!

• Total time – Several years

PATENT APPLICATION PROCESS

• 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 art?

– 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.

• Most Engineering-type inventions– Typically straightforward to describe and claim

in application– Examination typically limited to claim form in

view of prior art

• However, certain types of inventions require additional considerations:– Biotech inventions– Software inventions

PATENTABILITY REQUIREMENTS IN THE U.S. (Cont’d)

CONSIDERATIONS FOR BIOTECH PATENT APPLICATIONS

• Description and Figures―As detailed a description as possible, including

examples of several embodiments for a given invention

―In the ‘Examples’ section, inclusion of all relevant data, in vivo data always preferred

―Data figures• Claims

―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…

TYPICAL BIOTECH PATENT APPLICATION/PATENT

• 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 patentable.

• In Canada, methods of medical treatment & higher life forms are not patentable

BIOTECH PATENTS AROUND THE WORLD

• U.S. patent rules provide applicants with relatively flexible rules for amending claims during patent prosecution.

• 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 AROUND THE WORLD (cont.)

• The USPTO considers non-naturally occurring, non-human multicellular organisms, including animals, to be patentable subject matter― Microorganisms (bacteria, yeast, fungi)― Embryonic stem cells― Plants― Animals― 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.

• Recent Case Law/Issues― 2012 - Mayo Collaborative Services v. Prometheus

Laboratories, Inc.― 2013 – Ass’n for Molecular Pathology v. Myriad

Genetics― 2014 – AbbVie v. Janssen Biotech and Centocor

Biologics― 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

BIOTECH PATENTS IN THE U.S. (cont.)

CONSIDERATIONS FOR SOFTWARE PATENT APPLICATIONS

• Generally two main aspects for any type of software:

– Algorithms, methods, and other general concepts that describe, at a high level, how the software operates; and

– Actual computer code for implementing these concepts.

• Patents - Target the high level concepts• Other types of protection are typically used for

computer code (e.g., Copyright)

PATENTING SOFTWARE

• Description and Drawings:– Operating Environment– Particular/specialized components– Flow charts for each process– General Computer description/schematic

• Claims– Method– Computer-Product Claims– System Claims

TYPICAL SOFTWARE-BASED PATENT

EXAMPLE OF SOFTWARE PATENT

• Outside the U.S., obtaining software-based patents can be difficult:– 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 AROUND THE WORLD

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• 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 additional requirements

SOFTWARE PATENTS IN THE U.S.

• 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 title.

• Pre-2010 – Machine or Transformation (MT) Test

• 2010 - Bilski V. Kappos – MT test not sole measure of patentability.

• 2014 - Alice v. CLS - Claims directed to an abstract idea or a generic computer implementation of an abstract idea are ineligible for patent protection

MAIN ISSUE - IS A SOFTWARE-BASED INVENTION ELIGIBLE FOR PATENT PROTECTION?

• 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 idea?

• 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 technical

advantage?

• In sum a problem/solution or technical step type approach to determine patent eligibility– No clear guidance yet, but consistent with Post-Alice

decisions

SOFTWARE-BASED PATENTS AFTER ALICE V. CLS?

• Invention disclosures– Don’t limit description to just the software and how it

works– 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 advantage.

• 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 possible.

SO WHAT DO YOU NEED TO DO?

Eduardo Quinones, Ph.D., Esq.eduardo.quinones@novakdruce.com

(561)847-7822Amy A. Dobbelaere, Ph.D.

amy.dobbelaere@novakdruce.com(561)847-7809

Novak Druce Connolly Bove + Quigg LLPCityplace Tower, 15th Floor

525 Okeechobee BlvdWest Palm Beach, FL 33401

www.novakdruce.com

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Questions?