Protecting Your Intellectual Property: Cost-Saving Techniques, Legal Updates ...
MO Sept 2014
1. To File or Not to File: Threshold Patent
Application Disclosure Requirements and
Post-Filing Evidence Admissibility in the
U.S. and Foreign Countries
Presented By
Tracy Bornman
Crissa A. Seymour Cook
Thursday, September 11, 2014
University of Missouri System
2. 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?
3. 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
4. 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
5. 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)
6. 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
7. 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
8. 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
9. 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?
10. 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.
11. 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.
12. 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
13. 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
14. 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
15. 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
16. 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.”
17. 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
18. 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
19. 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
20. 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
21. 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
22. China – Post-Filing
Examiners do not readily accept post-filing data
because of issues related to satisfying the
requirements of: authenticity, legality, and
relevancy
