Presented by: Carla Todenhagen

1. Paradise Point Resort & Spa
San Diego, CA
October 19-21, 2011
Patenting Protein Therapeutics:
In the Shadow of Uncertainty
4th Protein Discovery and Therapeutics
Global Technology Community
Baltimore, MD
October 25, 2013
Big Changes in Patent Law:
The America Invents Act (“AIA”)
Society of Women Engineers
Annual Conference 2013
Speaker:
Carla Todenhagen

2. Klarquist Sparkman, LLP
America Invents Act: Purpose
• Harmonize US law with other jurisdictions
– Everywhere else: first to file
– Other jurisdictions have a post-grant opposition system
• Addresses concerns of many different groups
– Provisions discussed over the course of five Congresses
– Discussion in the courts and in industry on what needs
to be addressed
– Address significant backlog at the USPTO

3. Klarquist Sparkman, LLP
America Invents Act: Goals
• Encourage innovation and job creation
• Support USPTO's efforts to improve patent
quality and reduce backlog
• Establish secure funding mechanism
• Provide greater certainty for patent rights
• Provide less costly, time-limited
administrative alternatives to litigation

4. Klarquist Sparkman, LLP
List of (Some) of the Effects
• “First to File” replaces “First to Invent”
• Derivation proceedings replace interference proceedings
• Inventor’s oath or declaration – easier for assignee to file
• Supplemental Examination can be requested by patent
owner
• Post-grant review within 9 months of issuance
• “Inter partes review” replaces “inter partes
reexamination”
• 3rd party submission of prior art (pre-issuance)
• Citation of prior art in a patent file (post-issuance)

5. Klarquist Sparkman, LLP
List of (Some) of the Effects
• Patents with claims “directed to or encompassing a
human organism” prohibited (methods of treatment OK)
• New routes of expedited examination
• Best mode no longer a defense to patent infringement
• Establishment of micro-entities 75% reduction in fees
• Heightened bar for granting inter partes reexamination
(New “reasonable likelihood of success” standard)
• Virtual marking changes
• False marking changes
• Prioritized examination established

6. Klarquist Sparkman, LLP
First to File – New 102 Summary
• First inventor to file is entitled to patent
• Prior art is established as of effective filing date
• Date of invention is no longer relevant to prior art
– E.g., can’t swear behind a reference published within a year before
filing
• Public use or sale of the invention in a foreign country is
now prior art
– Prior statute limited prior art to public use or sale in the U.S.
• One-year grace now limited only to inventors that disclose
“subject matter” before date of prior art.

7. Klarquist Sparkman, LLP
Pre-AIA: First to Invent

8. Klarquist Sparkman, LLP
Post AIA: First to Invent File

9. Klarquist Sparkman, LLP
Prior Art
What is Prior Art? (New types of PA shown in red)
• Patent or printed publication anywhere
• In public use in US
• In public use in foreign countries
• On sale in US
• On sale in foreign countries
• Available to public in US (“known or used by others”)
• Available to public in foreign countries
• US patents and published applications as of EFD, including foreign priority
dates

10. Klarquist Sparkman, LLP
“First to File” - Prior Art, Examples

11. Klarquist Sparkman, LLP
First to File – Tips
• File early and often.
• Consider quickly filing provisional application, especially in
fast-moving technologies, before preparing more detailed
application.
• Risk: Non-enabled disclosures not entitled to priority date.
Balance filing with less enablement and risk that someone
else beats you to USPTO.
• Consider filing multiple applications directed to
improvements or variations to protect against filing or
disclosure by others.

12. Klarquist Sparkman, LLP
First To File: Removing Prior Art by
Disclosure
• If inventor is 1st to disclose invention:
• One year grace period to file application.
• This starts the clock. You have one year to file
a patent application once you disclose.
• More generous than Europe.
• A third-party disclosure within one
year of applicant’s filing date is NOT
prior art if the inventor disclosed
first.

13. Klarquist Sparkman, LLP
First to File-Disclosure Example
A publishes
SUBJECT MATTER A
Jan. 2014
A files app for
SUBJECT MATTER A
Dec. 2014
(<1 year from A’s
publication)
B publishes
SUBJECT MATTER A
Mar. 2014
B’s publication is NOT prior art to A
(But would be prior art to anyone else)

14. Klarquist Sparkman, LLP
First to File-Disclosure Example 2
• B’s publication is NOT prior art to A as to SUBJECT MATTER X.
• But SUBJECT MATTER Y is prior art. Claims to Y cannot be obtained.
A publishes
SUBJECT MATTER X
Jan. 2014
A files app for SUBJECT
MATTER X + Y
Dec. 2014
(<1 year from A’s
publication)
B publishes
SUBJECT MATTER X + Y
Mar. 2014

15. Klarquist Sparkman, LLP
First To File: Tips to Remove Prior Art
• Must “disclose” to get one-year grace period.
– But what is a “disclosure” under new law?
• No guidance in the AIA
• Does a disclosure have to be enabling? Likely.
• Does an offer for sale or public use without details of
invention count?
• If you want to rely on “disclosure” grace
period
– consider providing details of “subject
matter” of invention

16. Klarquist Sparkman, LLP
• CONS!
– Foreign rights will be lost in some countries by disclosing before filing.
– Loss of trade secret rights.
– Unclear how “disclosures” will be treated by courts.
– Gives competitors the chance to begin “improving” upon your ideas.
• Can a competitor file on SUBJECT MATTER A+B if you disclose SUBJECT
MATTER A?
– Extra cost associated with proving first disclosure.
• PROS?
– Cheaper than filing a provisional or other patent application?
– Ensures prior art effect as of publication.
• Abandoned provisional applications don’t publish.
– Prevents others from filing on the same invention while providing
the potential to file on the subject matter in the future.
First To File: Balancing Disclosure

17. Klarquist Sparkman, LLP
First To File: Removing Prior Art
• A third party disclosure within one-
year of applicant's filing date is NOT
prior art if:
• the inventor already disclosed the
invention prior to the third party
disclosure.
• derivation occurred.

18. Klarquist Sparkman, LLP
First To File: Removing Prior Art
by Derivation
• Disclosures by “another who obtained the
subject matter disclosed directly or indirectly
from the inventor” have a limited prior art
effect.
– A disclosure derived from the inventor is not
available prior art for one year.
– Patent applications or patents derived from the
inventor are not available as prior art as of their
“effective filing date” (only prior art as of their
publication date).
• How do you prove derivation?

19. Klarquist Sparkman, LLP
First To File: Removing Prior Art by
Common Ownership
• Patent application disclosures exempt as
prior art if common ownership or under
joint research agreement
– Old: only applies to obviousness rejections.
– New: Expanded to cover novelty and obviousness
rejections
• New: Common ownership no longer
required at time of invention, but must be in
effect on or before the effective filing date.

20. Klarquist Sparkman, LLP
Inventor’s Oath or Declaration
• Citizenship no longer required.
• Corrected oaths can be filed at any time
– Patent not invalid or unenforceable if a failure is
remedied in this manner.
• Oath needed before providing Notice of Allowance
– No more Missing Parts for unexecuted declarations?
• Separate oath or declaration no longer required.
– declaration statement can be made in assignment
documents.
– declaration statements can be made before preparation
of the application.

21. Klarquist Sparkman, LLP
Micro entity status
• Micro entity receive a 75% reduction of fees. As of today, the standard
minimum fee, paid by large entities, when a new utility patent application is
filed, is US$1,600.00. For the same application, a small entity pays only
US$800.00. A qualifying micro-entity will pay, according to today's fee
schedule, only US$400.00.
• A micro entity is any applicant that:
– Qualifies as a small entity
– Has not been named as an inventor on more than 4 previously-filed applications.
• Does not include foreign applications, provisionals, or international applications where basic
national fee was not paid.
• Applications from prior employment (which were assigned/under an obligation to assign) don’t
count.
– Did not, in calendar year before paying fee, have a gross income exceeding 3 times median
household income for that preceding calendar year, as most recently reported by the
Bureau of the Census. (Currently about $150k)
– Not be under an obligation to assign, grant, or convey a license or other ownership to
another entity that does not meet the same income requirements as the inventor.
• U.S. Institutions of Higher Education also qualify as micro entities.

22. Klarquist Sparkman, LLP
Prioritized Examination
• Cost: $4,800 ($2,400 for small entities)
• Final disposition (i.e., final rejection or allowance) within a year
• Utilities or plant applications only – not available for national
stage application.
• Request must be present at time of filing
• 4 independent claims and 30 total claims (subject to excess
claims fees)
• USPTO limit of 10,000 granted requests/year
• Warning – application converted to regular application if:
– Extension of time is filed
– Amendment results in more than 4 independent or 30 total claims
– RCE filed

23. Klarquist Sparkman, LLP
Third Party Pre-Issuance Submissions
• During prosecution, any third party may
submit:
– Any patent application, patent, or printed
publication
– Concise statement of relevance and fee required
– Timing restrictions

24. Klarquist Sparkman, LLP
Supplemental Examination
• Patent owner can request to consider, reconsider or correct
“information believed to be relevant to the patent.”
• Inoculates patent against potential inequitable conduct.
• Within 3 months of request, Director decides if a
Substantial New Question of Patentability is raised.
• A patent shall not be held unenforceable based on
information considered in supplemental examination. But
– Inapplicable to cure existing allegations
– "If fraud on the Office is determined, disciplinary or criminal actions can
be instituted.

25. Klarquist Sparkman, LLP
Post Issuance Challenges
• New Post-Grant Review
– Available within 9 months of grant
– “more likely than not” that at least one of the claims challenged is
unpatentable
– Challenge can be based on any ground for invalidity
– Opportunity for petitioner to file written comments after petition
• Inter Partes Reexamination becomes Inter Partes Review
– Available after 9 months of grant
– “reasonable likelihood that the requester would prevail”
• Note: change in threshold is effective now for Inter Partes
Reexamination
– Challenge can be based only on patents and printed publications.

26. Klarquist Sparkman, LLP
Marking
• False marking claims restricted
– Only U.S. government can sue for civil penalty of
$500/offense
– For private suits
• Must now show "competitive injury“
• Damages limited to amount "adequate to compensate for the
injury“
– No violations for marking with an expired patent.
• Virtual marking allowed
– Provide Internet address where full listing provided

27. Klarquist Sparkman, LLP
Thank You!
Questions?
ctodenhagen@klarquist.com