PATENTING BASICS ANDAMERICA INVENTS ACT

James R. Muldoon

JMuldoon@HarrisBeach.com

333 West Washington Street, Suite 200

Syracuse, NY 13202

315-423-7100

www.harrisbeach.com

INTELLECTUAL PROPERTY (IP)

Four Primary Types of IP:

• Copyright

• Trademark and Service Mark

• Trade Secret

• Patents

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COPYRIGHT

• A copyright protects the form of expression of a creator against copying

• Protects authors of "original works of authorship," including literary, dramatic, musical, artistic, and certain other intellectual works

• Protection is available to both published and unpublished works

• Examples: books, movies, music, sculptures, toys

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TRADEMARK

• A trademark is an indicator on a product used by a business to identify the unique source of the goods:

Snickers® brand candy bar identifies

Mars, Incorporated as the unique source

VS.

Ford Mustang Toyota Prius

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TRADE SECRET

• A trade secret consists of a formula, process, device, or compilation which one uses in business and which gives an opportunity to obtain an advantage over competitors who do not know or use it

• Trade secret protection requires material and substantial efforts by a business to develop and implement a trade secret protection program

• Summary: competitive business advantage + reasonable efforts to keep secret

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What is a PATENT - Definition

A patent is an exclusive property right granted by the U.S. Government to an inventor to:

• exclude others from making, using, offering for sale, or selling the invention

• throughout the United States, or • importing the invention into the United States

• for a limited time• in exchange for public disclosure of the invention

Enforceable by injunction, damages not less than a reasonable royalty• Methods of performing medical or surgical procedure on humans are

patent eligible, but medical practitioners are exempted from infringement claims (35 U.S.C. 287(c))

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What a patent is NOT

A U.S. patent does not give its owner an affirmative right to make, use or sell its claimed invention.

Only confers right to exclude other from practicing invention, unless owner’s permission is obtained.

Blocking patent Even a patented product may infringe another’s patent Freedom to operate searches, preferably prior to

product launch

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PATENTS - Types

• Utility Patent - protects the structure and utilitarian features of an invention from issue and until 20 years from filing (extendable for unreasonable PTO delays)

• Provisional Application: a legal document filed in the USPTO that establishes an early filing date, but which does not mature into an issued patent unless the Applicant files a Non-Provisional patent application within one year.

• Design Patent - Protects the ornamental appearance of an article of manufacture or portion thereof for 14 years from issue

• Plant Patent – Protects new and distinctive asexually reproduced plant varieties

• Sexually reproduced varieties protected by Plant Variety Protection Act

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Who is an Inventor?

Inventorship is a complex, legal question

NOT all authors on a research paper are necessarily inventors

Inventors make material contribution to the conception of the complete and operative invention as claimed in patent/application

If conception is workable invention, ultimate reduction to practice not relevant

If extraordinary skill required, individuals reducing to practice may make inventive contribution

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Who Owns the Patent

Inventor owns the rights to invention unless rights have been expressly or implicitly obligated to another

In absence of agreement to the contrary, each joint owner may use or license patented invention in U.S. without consent or accounting to other owners

Employment agreement can expressly assign rights to invention to employer

Holdover agreement – conceived during employment, reduced after employment – must be reasonable under circumstances

Implied Contract to assign invention Hired to invent or solve particular problem Position of trust – officer

Shop Rights – nonexclusive, nontransferable, royalty-free license Bayh-Dole Act allows universities to obtain exclusive rights in

technology developed under government funded research

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What can be patented?

• Patentable subject matter includes “anything under the sun that is made by man” Diamond v. Chakrabarty, Supreme Court, 1980

• “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.” 35 U.S.C. §101

• Process - A method, operation, or series of actions intended to achieve some end or result

• Machine - A device or apparatus consisting of fixed or moving parts that work together to form some function

• Article of manufacture - A thing that is made or built by a human being (or by a machine)

• Composition of matter - Two or more different substances, including all composite articles, whether resulting from chemical union or from mechanical mixture, and whether the substances are gases, fluids, powders or solids

• Improvements to any of the above

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What can NOT be patented?

Patents will not be granted for:• Laws of nature or scientific principles

• Gravity; Electro-magnetism (e.g., the principle of operation for Morse’s telegraph)• Physical phenomena

• Newly discovered mineral• Correlation between metabolite level and drug efficacy (Mayo v. Prometheus)

• Abstract ideas• Mental processes; Some methods of doing business; Computer software with no

structure• America Invents Act (Patent Reform Legislation Sept. 2011)

• Human organisms• Tax strategies

• Inventions which are:• Not physically possible (perpetual motion machines); or • Offensive to public morality

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Mayo Collaborative Svcs. v. Prometheus Labs.

U.S. Supreme Ct., March 20, 2012

A typical claim (claim 1 of US 6,355,623) in Prometheus’s patent reads:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8 x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

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Novelty Limitations – Current §102

Novelty (e.g., “New”) 35 U.S.C. § 102:– Applicant may only receive a patent for an idea not previously known

• Considered unfair to take away from the public that which is already in the public domain

• §102 sets forth 17 restrictions to patentability (too many for this discussion!)

• Restrictions can be summarized in 3 groups:• Events that take place prior to Applicant’s having invented the

invention• Events that occur prior to a fixed period of time before the U.S.

filing date• Miscellaneous; not related to time of invention or filing date

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Novelty Limitations (Continued)

Events that take place prior to Applicant’s having invented the invention: §102(a), §102(e), §102(g)

• Example: §102(a) The invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent

• Generally, an invention lacks novelty if any of the following pre-date Applicant's date of invention: (i) a patent; (ii) a patent application; or (iii) an invention in use or known of in the United States

• Date of invention refers to the date the Inventor can prove they invented• Depending on facts, could be the date of conception (but requires diligence), constructing the

claimed device or performing the claimed method, testing the device (including software simulation), or filing a U.S. patent

• Note that in the U.S., the first to invent is awarded a patent, not necessarily the first to file in the Patent Office. This provision ceases March 16, 2013.

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Novelty Limitations (Continued)

Events that take place a fixed period of time before the U.S. filing date: §102(b), §102(d)

§102(b) provides: the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States

• One year grace period between public use or sale and filing of application• Public Use – generally, whether the purported use was (i) accessible to the

public; or (ii) commercially exploited.• On Sale – generally, the invention is both (i) the subject of a commercial offer

for sale (not for experimental purposes) and (ii) ready for patenting

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Novelty Limitations (Continued)

Restrictions (Con’t)Not related to time of invention or filing date:

• §102(c): Inventor abandoned the invention• Requires a deliberate surrender of any rights to a patent, such as

intentionally dedicating to the public

• §102(f): Inventor did not invent the subject matter sought to be patented

• Applicant derived the invention from someone else (e.g., learned the complete system necessary for the invention)

• §102(g): Basis for interference practice

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Major Changes by America Invents Act

New 35 U.S.C. §102(a)-(d) substantially changes basis for novelty

First-to-Invent System will become First-Inventor-to-File Effective March 16, 2013

Broadens prior art to also include experimental uses and oral presentations

Retains limited one year grace period for invention derived by earlier inventor’s disclosure

Exempts disclosures under common ownership Includes joint research agreements in effect at time of filing Application must name joint research parties Invention must have been result of joint research activities

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Obviousness - 35 U.S.C. § 103:

“No patent will issue if the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art”

• Usually involves combining two or more prior art references to arrive at the claimed Invention

• Combination must have rational basis• Cannot combine elements from multiple references without

regard to their function or arrangement• Cannot use “hindsight,” that is, invention seemed obvious

after reading the application for patent

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Important Considerations for Researchers in view of America Invents Act

Documenting your invention Still important in case of claim of derivation proceedings Record public and confidential disclosures to collaborators

Determining if patenting is appropriate Sufficient commercial potential to merit costs and efforts

Size of market Non-infringing alternatives available Ease and cost of production and use Recognized need for invention Expected useful life of product Is trade secret protection preferable (reverse engineering) Defensive publishing

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Inventor’s Actions May Prevent Patenting in US or Abroad

Before a patent application has been filed, an Inventor should NOT

Submit document disclosing invention for publication or funding approval

Talk about invention to others not under NDA Demonstrate the invention to others not under NDA Offer invention for sale or advertise Sell the invention

Foreign patent rights based on absolute novelty

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PATENTS

Parts of a patent• Cover page• Drawings• Specification

(Detailed Description)• Claims• Abstract

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PATENTS – Drawings

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PATENTS – Detailed Description

• §112, 1st Para: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

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PATENTS - Claims

• §112, 2nd Para: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

• Independent claim stands on its own and does not refer to another claim (often referred to as “broad claim”)

• Provides highest level of patent protection

• Dependent claim depends from another claim, and is used to narrow the scope of the invention.

• Includes all recited elements plus the elements in the independent claim• “2. The device according to claim 1, further comprising …”• Narrowing the claim to dependent form may be necessary to overcome prior art

found during USPTO search, or raised during litigation

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PATENTS – Examination Process

PATENTSPATENTS

AllowanceFirst Examination

FirstFirstExaminationExamination

Notice Notice of of

AllowanceAllowance

Second Examination

Amendment

SecondSecondExaminationExamination

Appeal Process

Appeal BriefAppealProcess

Rejection

Courtesy of USPTO

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Conclusion

Questions?

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