Medical Device Patents

Pre-Conference Interactive Working Group Session Monday, February 27, 2012

9:00 a.m. – 12:00 p.m. (Registration and continental breakfast begin at 8:00 a.m.)

Mastering the Intricacies of USPTO Practice Post-Patent ReformBrian CaslerSupervisory Patent ExaminerUS Patent & Trademark Office (Alexandria, VA)

Tom Hughes
Supervisory Patent Examiner
US Patent & Trademark Office (Alexandria, VA)

Suzannah K. Sundby
Partner.
Smith, Gambrell & Russell, LLP (Washington, DC)

Richard S. Meyer
Partner,
Kilpatrick Townsend & Stockton LLP (Washington, DC)

In this hands-on highly interactive session, PTO examiners and leading patent counsel for device companies will guide you through the new examination landscape and share best practices on securing and maintaining patent protection cost-effectively in light of the game-changing implications of the Leahy-Smith America Invents Act (AIA).With device companies facing the compounded challenges of extended lag time in the patent approval process and increased fi ling costs, it is more crucial than ever to file patents flawlessly the first time. Benefi t from the experiences of PTO examiners who will give you the edge in streamlining the patent approval process in light of the broad changes at the PTO under the AIA. Prepare for potential challenges and new opportunities for medical device patent counsel. Points of discussion will include:

• Incorporating new PTO initiatives to reduce the backlog into your device patent practice to maximize device patent life
  • The advantages (and disadvantages) of the Patent Prosecution Highway
  • Controlling costs and reducing risks in the Accelerated Examination Process
  • PTO funding, fee diversions, and the pendency of patent applications
• Avoiding obviousness rejections: claim drafting strategies and preferred language to head an expensive rejection off at the pass
• Knowing your SPE: Working through impasses with examiners
  • Speaking the language of the PTO: What to include when crafting your response to an inquiry or rejection
• Preparing for the switch to first-to-file from first-to-invent: what considerations will medical device companies of all sizes have to factor in to their portfolio development and prosecution stratergies?

Pre-Conference Workshop Monday, February 27, 2012

1:00 p.m. – 4:00 p.m. (Registration begins at 12:00 p.m.)

The 510(k) Process and Patentability: Reformulating Patent Strategies in Light of Changes in the Regulatory Approval Process

Suneel Arora
Shareholder,
Schwegman Lundberg & Woessner (Minneapolis, MN)

Neil F. O’Flaherty
Principal,
Olsson Frank Weeda Terman Bode Matz PC (Washington, DC)

Statements made in the FDA submission process can come back to haunt a device company in a subsequent attack on patentability or in an infringement action. Major changes to the 510(k) process make the process of getting a device to the market more challenging than ever. In this session, leading device patent prosecutors and litigators team up with their device regulatory counterparts to give a 360-view of the interplay between FDA and PTO claims and put you in the best position to protect your intellectual property and market share:

• Bracing for an obviousness attack bolstered by statements made in the regulatory process to demonstrate substantial equivalence in terms of safety and efficiency
  • Contrasting substantial equivalence in the patent context and the regulatory context
• Preparing for how overbroad statements of equivalence may affect a novelty or obviousness analysis
  • What is discoverable from the filings?
  • What should litigators be looking out for?
• Anticipating how the specific technological characteristics of the chosen predicate device will affect both patentability and infringement
• Understanding how the statements made in the regulatory filings will play into the damages calculation
  • Willfulness and the totality of the circumstances test
• Exploring the possibility for patent term extension in the device context
  • Successful arguments device companies have used to tack time from the FDA review process back on a patent
• Looking beyond the U.S. regulatory process when planning your global regulatory approval strategy holistically: considerations for demonstrating safety and efficacy in the

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