Good Application Practice. Good Patent Claiming. Claims. Avoiding Contributory/Indirect Infringement. US Patent Reform 2011. FTFG. First-to-Publish. Introducing a Whole Gaggle of PIPs. Coming Soon: Lots More Rules!

1. 7/13/20181
Claiming Strategies for Medical Device Patent Application
PLUS – Bonus Update on Patent Reform:
New Laws and Rules
Brad Pedersen
April 6, 2011 Good Application Practice.
Good Patent Claiming.
Claims.
Avoiding Contributory/Indirect Infringement.
US Patent Reform 2011.
FTFG.
First-to-Publish.
Introducing a Whole Gaggel of PIPs.
Coming Soon: Lots More Rules!

2. SM
© 2011 Patterson Thuente Christensen Pedersen, P.A., some rights reserved - www.ptslaw.com
DISCLAIMER: This presentation and any information contained herein is intended for informational purposes only and should not be construed as legal
advice. Seek competent legal counsel for advice on any legal matter.
Claiming Strategies for Medical
Device Patent Applications
Plus
Bonus Update on Patent Reform:
New Laws and Rules
April 6, 2011

3. Claiming Strategies
for Medical Devices
July 13, 20183

4. Claiming Strategy Topics:
Good Application
Practice
Good Claiming Practice
Blocking Claims
Shoving Claims
Global Claims
Fast Track Claims
Using a “Jerry Maguire”
Strategy for Claiming
Avoiding Joint
Infringement
Avoiding
Indirect/Contributory
Infringement
July 13, 20184

5. Good Application Practice – Globalized Cases
Keep application concise and focused
Use a standard application template like PCT
Use terms with universally understood meanings
Use same terminology in specification as in claims
Include examples and tiered sets of ranges
Include reference numerals in claims/abstract
July 13, 20185

6. Good Patent Claiming: A Two Step Process
Identify the “invention” by
understanding the prior
art and why the invention
is different
Express the invention in
proper claim lexicon and
syntax
July 13, 20186

7. Jerry Maguire Claiming – “Show Me the Money!”
The whole purpose of a
patent claim is to provide
an economic advantage
Make sure that claims are
drafted to protect how the
invention will be
commercialized
July 13, 20187

8. Blocking Claims
The “Small Size” ICD patent
Claimd ICD < 90 cc
Effective capacitance < 120 uF
For pectoral implantation
Licensed to every ICD Mfg
Claims blocked others from
offering pectoral implants
Claims allowed because -
Application told a “story” of a
claimed range that went
opposite to what prior art taught
July 13, 20188

9. Shoving Claims
The “Insorb®” patents
To an absorable stapler
For SubQ stapling
Prior SubQ Art – a spike, so
Claims to a bilateral fastener
Skin everted without overlap
Staple arms deform over time
Claims don’t completely block
Other kinds of absorbable staples
may not infringe, but they also
won’t work as well
July 13, 20189

10. Global Claims for Medical Technology
Do’s
Create base claim set
of < 15 claims
Layer fallback
patentable features in
dependents
Create OUS claim sets
• method claims
dependent upon
apparatus claim
• multiple dependent
claims
Don’ts
Seek classic method
claims outside US
Use “means” language
(other than for US)
Wait to draft claims for
OUS until filing national
stage cases
July 13, 201810

11. Fast Track Claims
On May 4, 2010: “Track I – Fast Track” prosecution
Cost - $4,000 Track I examination fee, plus usual publication and
processing fees (No small entity discount for Track I exam fee)
Requirements – limit of 4 independent claims, 30 total claims, no
requests for time extension or RCEs
Applications – new applications (either original or continuing case),
but not reissues or reexams
Limits – first 10,000 properly filed applications received in FY2011,
then limits will be revisited for FY2012
Goal – final disposition of case in 12 months (Final Rejection or
Notice of Allowance)
http://edocket.access.gpo.gov/2011/pdf/2011-7807.pdf
July 13, 201811

12. Direct infringement requires showing that defendant
practiced each and every element of claim
But contributory infringement under 35 USC 271(c)
can also result in infringement
Contributory/Indirect infringement requires finding
that some single party has committed the entire act
of direct infringement, plus
a “specific intent” to induce infringement
evidence that defendant controlled or directed each step of
the patented process
BMC Resources v. Paymentech, 498 F.3d 1373 (Fed. Cir. 2007)
July 13, 201812
Avoiding Contributory/Indirect Infringement

13. Court in BMC counsels that claims can be drafted to
avoid the need to prove or rely on joint infringement
For most kinds of medical apparatus, this is
straightforward, but
For some medical technologies, method claims or
data claims may be the stronger patentable claims,
and drafting effective method claims can be difficult
Medical provider may be direct infringer
Makes issues of proof complex and expensive
Damages for method claims are also complex
July 13, 201813
Avoiding Joint Infringement

14. Method Kit Claims
The “Hudson” patents
To MIS Total Knee Arthroplasty
For medial/lateral approaches
Cutting Guides are Key
Claims to resecting knee for total
knee implant from just one side
Method infringed only by surgeon
Method Kit Claims
Providing cutting guides
Providing instructions for using
guide to cut from just one side
July 13, 201814

15. Updates on Patent Reforms
July 13, 201815

16. US Patent Reform 2011: The America Invents Act
Momentum is building
S.23 bill passed Senate: 95 – 5 vote with full White House support
House has introduced HR.1249
Two bills are very similar other than Post Issuance Procedures (PIPs),
prior use rights and business method patent definition
Reconciled bill is likely to be completed and signed into law this year
Main provisions of S.23
Moves U.S. to a first-to-file with one-year grace period (FTF w/grace)
Resolves funding problems by giving USPTO authority to set fee and
ending fee diversion
Introduces several new PIPs with shorter time frames
Provides for meaningful third party submission options
Controversial litigation provisions dropped, except for changes to limit
patent marking lawsuits and drop best mode
July 13, 201816

17. July 13, 201817
FIG. 1 – Scenarios where both parties are seeking a patent
(based on hypothetical evaluation of weighted likelihood of 200 typical
fact patterns from “The Matrix” article at Cybaris IP Law Review)
FTFG Will Be Different – Two Filer Scenarios

18. FTFG Will Be Different – One filer scenarios
July 13, 201818
FIG. 2 – Scenarios where only 1 party is seeking a patent
See, http://web.wmitchell.edu/cybaris/wp-
content/uploads/2010/05/01.Pedersen.05-12-10-
vFINAL.WITHAPPENDIX.pdf

19. FTFG Will Be Different – Derivation scenarios
July 13, 201819
FIG. 3 – Scenarios involving fact patterns with derivation issues

20. FTFG and Creeping Disclosures
Assume different inventors disclose different, but related, subject matter
For identical disclosures, Congressional Record confirms that if:
A publishes 1 + 2 + 3
then B publishes or files for 1 + 2 + 3
then A files for 1 + 2 + 3
the patent goes to A by 102(b)(1) (B) and 102(b)(2)(B) exceptions
The harder/more interesting cases involve “creeping disclosures”:
A publishes 1 + 2 + 3
then B publishes or files 1 + 2 + 4
then A files for 1 + 2 + 3, and also 1 + 2 + 3 + 4
A gets patent to 1 + 2 + 3, but is A entitled to 1 + 2 + 3 + 4?
Maybe – it probably depends on whether adding 4” is or is not
obvious over the combination of 1 + 2 and/or 1 + 2 + 3?
7/13/201820

21. First-to-Publish “Best Practices”
Taking advantage of the first-to-publish exceptions of 102(b)(1/2)(B)
File provisional application based on invention disclosure – ASAP
Take time to review provisional and publish “expanded” version that
“discloses” alternate embodiments to trigger broadest grace period
Before “publishing” to invoke grace period, if OUS protection desired,
file second “expanded” publication as a second provisional
OPTIONAL - If additional developments and/or research occurs
consider filing a third provisional with any additional material
Prepare and file utility application by 1-year date of first provisional
If OUS protection desired, determine whether to
• file PCT application with reduced EP style claims( 16 claims)
or
• file direct if number of countries is limited (4) and there is a
potential to use PPH
7/13/201821

22. Introducing A Whole Gaggle of PIPs
Old PIPs
Interferences
Reissue
Ex Parte Reexam
Inter Partes Reexam
New PIPs
Derivations
IE Absolution
Bus. Method Challenge
Post Grant Review
Inter Partes Review
7/13/201822

23. Introducing A Whole Gaggle of PIPs
Patent Owner Fixes
Reissue – unchanged
Ex Parte Reexam –
unchanged
IE Absolution – new
way to absolve patent
owner (but not patent
attorney) from charge
of Inequitable Conduct
Inventor Challenges
Interference – phased
out over 4 years
Derivation – primarily
for disputes about theft
of invention fact
patterns for new cases
filed under FTFG, but
see discussion of
creeping disclosures
7/13/201823

24. Introducing A Whole Gaggle of PIPs
3rd Party Challenges
Ex Parte Reexam –
unchanged
Inter Partes Reexam –
phased out over 4
years, standard to
initiate may or may not
change from SNQ to
reasonable likelihood of
prevailing
3rd Party Challenges
Post Grant Review –
phased in over 4 years,
run by APJ for all kinds
of challenges, must be
started in 1st window
Inter Partes Review –
mostly same as PGR
but in 2nd window and
limited to publ or
patents and Statements
7/13/201824

25. Introducing A Whole Gaggle of PIPs
3rd Party Challenges
Business Method
Challenge – lower
standard for 4 years to
initiate a reexam of
certain types of
business method
patents
7/13/201825
Senate – limits to only
financial-type business
methods
House – expands to
any non-technical
business method

26. Coming Soon: Lots More Rules!
Ex Parte Appeal Rules – final comment period ended in January
Big Picture Comments on Exec Order to streamline rules – due April 21st
Fast Track – starts May 4th
Section 112 guidelines/rules - ??
Petition practice guidelines/rules - ??
True Electronic File Wrapper – pilot project soon in CRU
7/13/201826

27. Thank you!
Brad Pedersen / 612.349.5740 / pedersen@ptslaw.com
July 13, 201827