To File or Not to File: Threshold Patent Application Disclosure Requirements and Post-Filing

Evidence Admissibility in the U.S. and Foreign Countries

Presented ByTracy Bornman

Crissa A. Seymour Cook

Thursday, September 11, 2014 University of Missouri System

What and When?• What kind of information, data, disclosure is

needed for meeting threshold requirements in various countries?

• When do you need to/When can you present this information, data, disclosure?

• What are the pitfalls and best practices?

United States• Major issues:

– Written Description– Enablement– Best Mode– Definiteness

• Addressed in 35 U.S.C. 112• Inverse relationship to the level of

“predictability” of the field of the invention

US – Minimum Requirements• Written Description

– Description of invention that demonstrates possession of invention as of filing date

• Enablement– Describe how to make and use invention

• Working examples, Prophetic examples• Figures

– Some experimentation permitted…must not be undue• Best Mode? Best practice to still include • Definiteness: clarity and precision in terminology

United States – What and When?• Written description, enablement, best

mode, and definiteness must be satisfied at time of filing.

• How? – Provide text to support different embodiments– Include as much relevant data as possible– Working examples typically included and generally

recommended– Detailed drawing figures (picture worth a thousand

words)

United States – Post-Filing• During patent prosecution, evidence may be

submitted to show:– Sufficiency of original disclosure

• e.g., in vitro and/or in vivo test results consistent with teachings of specification

– Utility/Enablement- operability of claimed invention – confirmation of asserted utility

– Novelty- rebut allegation of inherency in prior art, demonstrate prior art is non-enabling

– Nonobviousness- secondary considerations, e.g., unexpected results, commercial success

– Establish level and knowledge of one of ordinary skill in the art

United States – Post-Filing• During prosecution, evidence may NOT

be submitted to:– Add new matter or data to the application– Demonstrate that the invention has now

been enabled• Any evidence must have a basis in the

original filing, or be used to support original disclosure, and consistent with original disclosure

Canada – Minimum Requirements• Similar disclosure requirements as the U.S.,

set forth in section 27 of the Canadian patent act:– “Correct” and “full” description of the invention– Enabling disclosure – “undue” experimentation

standard– Best Mode– Process claims require a description of the

necessary sequence, if applicable• Utility – higher threshold

Canada – Minimum Requirements• Utility Requirement – evolving issue

– Inventor has actually demonstrated utility prior to the application filing date, or

– Inventor has data and a line of reasoning for sound prediction of utility

– “Promise Doctrine” – what utility does the disclosure promise of the invention?

Canada – Minimum Requirements• Promise Doctrine:

– Requires the inventor to “soundly predict” how its invention will be used and essentially prove via data in the application hat the invention will successfully fulfill its promise

• Considerations for satisfying utility:– Avoid “over promising” - Do not include statements

in the description that could be read as a promise of a utility that is not clearly supported

– Provide explicit statement linking data to utility and align claim scope accordingly.

Canada – Post-Filing• Post-filing evidence that is admissible:

– Adding matter that can be reasonably inferred from application as filed

– Incorporating prior art so long as it is admitted* in the specification that the matter is prior art with respect to the application (benefit must be weighed against treatment of admissions in U.S.)

• Canadian Examiners are under no obligation to review post-filing submissions.

Canada – Post-Filing• Post-filing evidence that is NOT admissible:

– Post-filing data is not permitted to support predictions about a claim’s utility or soundness. 

– New Matter: any information that cannot be inferred from application as filed and that is not admitted prior art

– Adding prior art to support a sound prediction of utility, where it would not have been clear to one skilled in the art which of the teachings in the prior art were necessary for this purpose

Europe – Minimum Requirements• Article 83 Disclosure of the Invention

– Demonstrate at least one way of carrying out invention that is performable over whole claim scope

– Repeatability/reproducibility of information – “undue” experimentation standard

– Sufficiently clear and complete description – Europe has a stricter written description requirement than the US

• Article 56 Inventive Step– Application as filed must plausibly demonstrate that the

problem is credibly solved over the whole breadth of the claims

Europe – Minimum Requirements• Considerations for satisfying sufficiency

of disclosure and inventive step:– Include experimental evidence desired

technical effect is achieved (working example), or solution is plausible in view of background of person of ordinary skill in the art (prophetic example)

– Evidence that invention can be carried out over whole breadth of claimed invention

– Data is required for medical use claims

Europe – Post-Filing• Article 83 Disclosure of the Invention

– Post-filing data is NOT admissible to establish sufficiency of the original disclosure – must meet minimum requirements as of filing date

• Article 56 Inventive Step– Pharma/biological data admissible as long as it merely

proves the technical effect related to originally stated problem

– Data admissible as long as it merely confirms invention works and is not used to establish enablement of the invention – i.e., POC of a prophetic example

China – Minimum Requirements• Article 26, paragraph 4, of the Patent

Law of the People's Republic of China:

“The claims shall be supported by the description and shall state the extent of the patent protection asked for.”

China – Minimum Requirements• Practical Application: - Application must include a “sufficient number” of

examples to allow a person skilled in the art to understand how to carry out the invention and to determine that the invention, when it is carried out, will achieve the effect as expected through the entire scope of the claims.

- “Expectations” set up by disclosure might create issues if not fully supported by data – don’t overpromise

- Issue related to inventions where the underlying mechanism of action is not well understood, in combination with broad claims

China – Minimum Requirements • Sufficiency Issue

– Disclosure must not only enable one skilled in the art to carry out the invention, but must enable that person to readily expect the effects/functions of the claimed invention to be obtained based upon this disclosure.

• Support Issue– Strict reading of application disclosure– “Undue” experimentation is the standard for

enablement – Inclusion of preparation examples and test data

regarding effects is expected

China – Minimum Requirements • Must also demonstrate that the

invention has an inventive step– Explanation for inventive step usually needs to

be in line with the expected outcome/data in the application

China – Minimum Requirements • Considerations for satisfying sufficiency

and support issues and inventive step:– Set different levels: preferable, more

preferable, further more preferable– Disclose/describe more alternatives– Provide more examples– Include sufficient experimental/test data rather

than declarative conclusions

China – Post-Filing• Post-filing evidence may be submitted  

– To address rejections related to sufficiency of disclosure or support, data may be admitted if it is consistent with the original teachings of the application as filed.

– To address a rejection based upon of lack of inventive step, data may be used, so long as it the demonstrated technical effect is consistent with the original teachings of the application as filed  

– Prior art documents are also usually admissible

China – Post-Filing

Examiners do not readily accept post-filing data because of issues related to satisfying the requirements of: authenticity, legality,

and relevancy

Any Questions?Tracy Bornman

tbornman@hoveywilliams.comCrissa A. Seymour Cookccook@hoveywilliams.com

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