Patent Enablement

How to Make and Use an Invention Without "Undue" Experimentation

Under 35 U.S.C. §112(a), courts use the “Wands factors” to help determine whether the disclosure meets the enablement standard. These factors include:

The quantity of experimentation necessary,
The amount of direction or guidance presented,
The presence or absence of working examples,
The nature of the invention,
The state of the prior art,
The relative skill of those in the art,
The predictability or unpredictability of the art, and
The breadth of the claims.

In re Wands, 858 F.2d 731 (Fed. Cir. 1988).

Whether a patent application is enabled is also dependent upon the subject matter of the invention. A line of cases related to "predictable" inventions suggests that a single example of making and using the claimed invention is sufficient for enabling a person to practice the scope of patent application without undue experimentation. In a second line of cases related to "unpredictable" inventions such as biotechnology, pharmaceutical, and to a lesser degree medical device inventions, courts have held that a range of examples is desired to meet the enablement requirement.

Thus, it is our practice at Torrey Pines Law Group to describe as many alternative embodiments of an unpredictable invention as possible. If a variety of homologous polynucleotide or polypeptide sequences are effective in the invention, we ask our clients to descbibe them in examples. Examples are likewise requested with respect to alternative vectors, cell lines, salts, indications, analogs, algorithms, and the like. This provides the best opportunity to fully enable a patent application and issued patent.

Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.

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