Medical Device Patents

Monday, March 4, 2013

Pre-Conference Interactive Working Group Session A

9:00 a.m. to 12:00 p.m. (Registration begins at 8:00 a.m.)

Integrating Changes at the PTO into Medical Device Patent Practice: Supervisory Patent Examiners Weigh In

Brian Casler
Supervisory Patent Examiner
US Patent & Trademark Office (Alexandria, VA)

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

Jonathan D. Feuchtwang
Senior Counsel
Abbott Vascular (Santa Clara, CA)

Douglas Portnow
Patent Attorney
Wilson Sonsini Goodrich & Rosati (Palo Alto, CA)

With medical device companies facing the compounded challenges of increased filing costs and a hefty medical devices tax, it is more crucial than ever to file patents flawlessly the first time to protect crucial market share. This already complex task has become immeasurably more difficult as the game-changing provisions of the Leahy-Smith America Invents Act (AIA) go into effect, including the historic switch to first-to-file. In this hands-on highly interactive session, current PTO examiners and leading in-house 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. Revamp your intellectual property strategies as the broad changes at the PTO under the AIA go into effect based on the insight and experiences of PTO examiners who will give you the edge in streamlining the patent approval process. Weather this perfect storm of unpredictability and uncertainty and brace for potential challenges — and new opportunities — for medical device patent counsel based on a one-on-one breakdown of new PTO practice with the SPEs themselves:

• 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
• Mastering the intricacies of USPTO practice both patent reform
  • Bracing for the historic switch to first-to-file from first-to-invent: what considerations should medical device companies factor into their overall portfolio development and prosecution strategies based on what the PTO has seen to date?
  • Exploring how the AIA has affected and will continue to affect patent practice
  • Broadening prior art and weakening inequitable conduct: what should patent applicants reasonably include in their PTO disclosures now?
  • What tools and resources is the patent office use to sift through a huge new quantity of info constituting prior art?
• Incorporating new PTO initiatives to reduce the backlog into your device patent practice to maximize device patent life
  • Update: PTO funding, fee diversions, the pendency of patent applications and what this means to the timing of your applications
  • Controlling costs and reducing risks in the Accelerated Examination Process
  • Weighing the advantages (and disadvantages) of the Patent Prosecution Highway
• Avoiding obviousness rejections: claim drafting strategies and preferred language to head an expensive rejection off at the pass

Pre-Conference Master Class B

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

Maximizing Device Patent Scope and Life: Navigating Through the Medical Device Patent Minefield

James E. Kemler
Group President-Regenerative Medicine
Stryker (Cambridge, MA)

William G. Abbatt
Patent Attorney & Shareholder,
Brooks Kushman P.C. (Detroit, MI)

Michelle Arney
Intellectual Property Strategist, Tera
Recon, Inc. (Foster City, CA)

Major changes to the device patent prosecution and litigation practice coupled with changes in the 510(k) process and a marked uptick in litigation have made the process of getting a device to the market more challenging than ever. In this session, leading medical device patent prosecutors and litigators team up with their regulatory and transactional counterparts to give a 360-view of the interplay between all the key players who must work together effectively to get a device to the market. Attending this session will put you in the best position to protect your intellectual property and market share as you walk away with best practices to truly understand the value of your IP.

• Protecting the invention: Coaching inventors on the basics of recognizing the value of a new and useful idea as IP
• Checklist for companies: what should you be looking for when deciding to invest in an invention?
  • Determining patentability and forecasting profitability
  • Avoiding untimely disclosure: when, where, and how much to file on in light of the new AIA first-to-file provisions
  • Formulating the prior art search: what is out there and do you have freedom to operate?
  • Realistically anticipating the costs involved
• Performing the diligence analysis to determine the strengths and weaknesses of someone else’s patents
  • Risk assessment of third-party patents
• Maximizing the value of the IP in your portfolio
  • Mining active patent applications for better claims
  • Keeping key patents alive in the patent office for future claim mining
  • Preventing against design-arounds
  • Licensing considerations — in and out
  • Is patenting the way to go for you: weighing the benefits of trade secret protection
  • Managing your patent portfolio like a product portfolio
  • Developing more than an approach to patents: developing a patent strategy
  • Knowing your patent portfolio and keeping it lean
  • Knowing your competitors' patents and using them
• Exploring patent portfolio monetization and patent consortiums
  • Developing an offensive patent portfolio with claims directed at competitors’ products
• Understanding how the statements made in the regulatory filings will play into subsequent litigation
  • Bracing for an obviousness attack bolstered by statements made in the regulatory process to demonstrate substantial equivalence in terms of safety and efficacy
  • Preparing for how overbroad statements of equivalence may affect a novelty or obviousness analysis
  • Anticipating how the specific technological characteristics of the chosen predicate device will affect patentability and infringement
• Bringing together patent prosecution counsel and litigation counsel: case studies of broad v. narrow claim drafting strategies and the downstream consequenc

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