2. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Assessing FTO on a Budget Part 1 Analysis before the FTO

3. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Before the FTO Basic Research Preliminary Analytics Preparation for the FTO

4. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Basic Research Competitors Fields of technology – Subordinate technologies – Analogous areas of technology Names of individuals known in your market What do you want to do?

5. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Patent Analytics Goals What is available What is useful What is cost effective

6. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Patent Analytics Search Statistical or Bibliographical Analytics Ontology or Classification of Patents Visualization Derivative Analytics

7. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Search Commercial Services – Thomson, Reed Elsevier, Questel Freemium/Free – Google Patents, Freepatents, Sumo Brain Iterative Identification of – Competitors – Patents/Patent Applications/Papers/Etc – Researchers and other relevant inventors

8. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Statistical/Biographical Analysis Graphs/charts Trends Dashboards and Monitoring WhoWhatWhenWhereHow much? InventorsPortfolioPriorityCountriesCitation* AssigneesTechnologiesTransfersRegionsOppositions* LitigantsFamilyExpirationCitiesReported *Proxy value

9. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Dashboards 9 Acme

10. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Activity Monitoring

11. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Post Grant Monitoring ResearchDiscernAct Post Grant StatisticsPost Grant OptionsFile Post Grant Action Examiner StatisticsAppeal OptionsFile PTAB Action PTAB StatisticsPTAB Actions

12. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Ontologies / Classifications Family – INPADOC – Derwent® World Patent Index Field of Technologies – International Patent Classifications (IPC) – USPTO Classifications – Derwent® Custom Functional Ontologies

13. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Visualization of Results Citation Trees Key Word Topographical Maps Network / Relationship Mapping Heat Mapping / Landscaping

14. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Citation Trees

15. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Key Word Topographical Maps

16. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Network/Relationship Mapping

17. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Heat Maps / Landscapes

18. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Derivative Analytics Merger of Financial Data Development of Efficiency Studies Patent Bionics – Human Analysis with Machine Assistance – Claim Abstraction – FTO/White Space /Licensing Analysis – Design Around /Competitive Analysis

19. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Merger Of Financial Data Extract financial from accounting system Correlate them to unique matters – Derive matter / cost studies – Derive portfolio / cost studies Correlate law firm bills to issuance rates 19

20. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Efficiency Analysis

21. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Art Unit Efficiency Analysis

22. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Patent Bionics Human analysis with machine assistance – Claim mapping and abstraction is key to FTO analysis Engineering design around Patent strategy white space Inbound and outbound licensing analysis Gap analysis in portfolios Mapping product literature to claims – Interact with the map of claim abstraction 22

23. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Introduction to Claim Mapping Claims largely define a patents value Claims between patents may be – Abstracted – Harmonized – Mapped Thus claims may be assigned ontologies – Similar to case law headnotes 23

24. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Headnotes (+ ATTORNEY) Scope Concepts What the claims say about the technology Limitations Varying Levels of Abstraction Abstracting: Case Law vs. Patent Claims

25. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Output of Abstracting Interactive Excel spreadsheet – Usable by anyone Outside Patent Counsel Inside Patent Counsel Engineers – Most Critically! Best Practice: Outside Patent Counsel + Inside Patent Counsel + Engineers – Embeds All Elements Rule for infringement If a scope concept in claim is absent from the design, can rule out that claim If the scope concept appears in many claims, can eliminate many claims Exclusionary tool: patent attorney reviews all claims that have not been ruled out – Easily updatable as new patents issue Chart once, use forever Output of Abstracting: ClaimBot®

26. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Comparison: Traditional vs. ClaimBot ClaimBot® FTO Process: Parallel Traditional FTO Process: Serial Design Change Done No Yes Start Over Map Scope Concepts Design Features Design Change Merely Changes Applicable Concepts Since Concepts Are Mapped To Claims, Youre Almost Done! First concept of first claim Claim Analysis v. Claimbot Abstraction

27. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Output of Abstracting: Spreadsheet Claims Needing Further Review are Automatically Identified (in red) Scope Concepts (minimal client time needed) Potential Relevance (1, 2, or 3 – client provides input about present & future design ) Individual Patents (separated by violet and white columns) Independent claims Current Interest Future Interest Not of interest Key Output of Abstracting: Interactive Spreadsheet

29. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Assessing FTO on a Budget Part 2 FTO on a Budget

30. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. 1. What is an FTO clearance review? 2. Necessity of an FTO clearance review. 3. Situations that trigger an FTO clearance review, and timing. 4. The FTO process. 5. Cost and time considerations. 6. Drawbacks with FTO process. 7. Strategies resulting from an FTO analysis after identifying relevant patents. 8. Patent Infringement (distinguished from Patentability/Invalidity). 9. FTO scenarios. 10. Final thoughts. Overview of Todays FTO Discussion

31. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Definition: "Freedom to operate", abbreviated "FTO", refers to whether a particular action, such as commercializing a product, can be done without infringing valid intellectual property rights of others. What is an FTO clearance review?

32. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Expired patents should be considered Infringement analysis (comparison of claims and technology) What is an FTO clearance review?

33. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Blocking patents (injunction). Patent infringement (monetary damages). Recent (past 10 years) surge of newly issued U.S. patents. Raises significance to conduct FTO clearance review. Non-practicing entities (NPEs) or Patent Trolls. Cant simply cross-license or counter sue. Necessity of an FTO clearance review

34. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Clearing prospective in-licensed (or acquired) technology – Before in-licensing (acquiring) technology Clearing R&D pipeline (technology) – Before launching product in the U.S. market – During R&D (the dance to continually clear evolving R&D technology) – At any time Newly issued, published, expired and/or identified patents Situations that trigger an FTO clearance review

35. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. After R&D – Can minimize costs – May force substantial redesign if applicable art is found At product launch – Substantial redesign of a product slated for release, delay of release, retooling of manufacturing processes and lines – Withdrawal and/or reworking of marketing materials and strategies – Bad PR for the manufacturer FTO during R&D, after R&D or at product launch?

36. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. During R&D – Best practice – Generally will result in a clear design during R&D with possible design changes as additional patents issue or applications publish – Likely the most expensive and time consuming scenario with counsel because it requires an iterative review of multiple permutations of a design and repetitive reexamination of references applicable to the design FTO during R&D, after R&D or at product launch?

37. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Patent searching – Issued U.S. Patents – Published U.S. Patent Applications – International searching – May require interaction with foreign agents to complete a search (especially in developing countries where electronic tools are scarce); also an added expense Review and triage patent documents (filtering out irrelevant patents) The FTO process

38. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Infringement/non-infringement analysis All Elements Rule Broad/dominating claims vs. narrow/subservient claims Claim interpretation and Markman Hearings Doctrine of equivalents (DOE) 35 U.S.C. § 271(g) issues (processing claims) Materially changed Non-infringing use Burden of proof shifts The FTO process

39. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Drafting the document (opinion or clearance summary) memorializing attorney analysis, and communicating analysis to client Document is updated (and additional searching performed) as relevant patents expire, publish and/or issue (continued prosecution risk) May need to perform a search again, as there are often continuation and divisional patent applications Need to search for reissued claims that could be broader than what was originally cleared The FTO process

40. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Recent (past 10 years) surge of issued U.S. patents increases number of patents to review – large number of patent documents to be aware of Patent searching, time and costs Review and triage patent documents, time and costs Drafting the document, time and costs Updating searching, time and costs Updating document (opinion or clearance review), time and costs Cost and time considerations

41. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Accuracy and comprehensiveness of searching Accuracy of analysis of attorney work product – Technical – Legal Timing (when to perform FTO) Comprehensiveness and analysis of attorney work product – Typically only 1-2 hooks of non-infringement provided – Time-consuming and expensive to document all grounds for non-infringement where there is a large number of relevant patents Drawbacks with the FTO process

42. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Time and costs incurred (including updates) Ease/difficulty in understanding analysis and attorney work product by: – Executive or manager – Technology officer (scientist/engineer) – Patent attorney/agent – Business development officer – Licensing manager – Product manager Irrelevant patents never completely eliminated, due to evolving technology of R&D Drawbacks with the FTO process

43. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Key or problematic patents not flagged for attention (or follow-up) Personnel involved with FTO process (individuals with key attributes often do not contribute) White space opportunities (effective means to identify new technology development opportunities) typically not provided Large scale (500 + patents) patent review and clearance is relatively inefficient and costly Drawbacks with the FTO process

44. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

45. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

46. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

47. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

48. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

49. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

50. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

51. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

52. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. One Approach to FTO: ClaimBot Claim Matrix

53. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Purchase the patent (or assignee), or in-license the patent Cross-license the patent Design-around the patent Patent pools with the patent Patent infringement and subsequent litigation – Patent non-infringement position – Patent invalidity position Reexamination or post-grant proceeding Ostrich approach Technology is clearly non-infringing, and the client proceeds as-is, on the basis of the FTO clearance review and analysis Post FTO Strategies

54. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Contrast Patentability and Infringement X COMPANY AS GRANTED CLAIMS COMPANY AS PUBLISHED DISCLOSURE Z Z THIS AREA COULD BE PATENTABLE – IT WOULD NOT BE INFRINGING

55. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Contrast Patentability and Infringement X COMPANY AS GRANTED CLAIMS COMPANY AS PUBLISHED DISCLOSURE Z THIS AREA IS INFRINGING -- BUT IT COULD STILL BE PATENTABLE Z

56. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Patent claim recites a specific use of a protein. Your device uses (same use) a novel protein having 75 amino acids. Is there an infringement concern? Patent claim recites specific protein (both broadly and narrowly). Patent specification discloses many uses of the protein, none of which include your use. Is there an infringement concern for your specific use of the protein? Scientific literature discloses a similar protein for a similar use. Is there an infringement concern for your specific use of the protein? Your device (assay) includes a specific protein for a specific diagnostic use. The device is patented. Is there an infringement concern to commercialize the device? FTO Scenarios

57. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Patent claim recites (a wholly different) use of a specific protein. Patent specification states that the invention also includes the protein per se. Is there an infringement concern to commercialize your (wholly different) use of the protein? Patent claim recites (amongst other limitations) the term protein. The patent specification provides an extensive list of suitable proteins, none of which is the specific protein you plan to commercialize. Is there an infringement concern to commercialize your specific protein (assuming all other claim limitations are met)? An expired patent claims a specific protein, and claims and describes a general use of the protein. You want to use that same protein for a very specific use (which falls under the general use). Is there an infringement concern to commercialize your (specific) use of the protein? FTO Scenarios

58. Copyright 2010 Schwegman, Lundberg & Woessner. P.A. All Rights Reserved. Freedom-to-Operate and infringement issues are legally based. As such, any comments, concerns, suggestions, admissions, characterizations, exculpatory remarks, inculpatory remarks, etc. of an infringement analysis (or claim construction) by a non-patent attorney or agent should not be done in writing, but instead in person or via telephone (not voice mail). Remember the adage: anything you say [memorialize in writing] can and will be used against you in a court of law. Rule of Thumb: Always check first with your in-house counsel (verbally). Final Thoughts