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Strategic Intellectual Property Protection

Hsiu-Ming Saunders, Ph.D, J.D. Attorney at Law U.S. Tel: (650) 610-9136 mingsaun@gmail.com Aug. 2007. Strategic Intellectual Property Protection. Table of Contents. What is a Patent? Patent Value Proposition Two Prongs of Patent Strategy Patent Process Budgeting

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Strategic Intellectual Property Protection

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  1. Hsiu-Ming Saunders, Ph.D, J.D. Attorney at Law U.S. Tel: (650) 610-9136 mingsaun@gmail.com Aug. 2007 Strategic Intellectual Property Protection

  2. Table of Contents • What is a Patent? • Patent Value Proposition • Two Prongs of Patent Strategy • Patent Process • Budgeting • Overcoming Examiner Rejections – Real cases • Problems encountered by Asian inventors in Applying for U.S. Patent Applications

  3. What is a Patent? • Patent types - Utility - Design - Plant

  4. Patentable Subject matter • “machine” - apparatus, e.g., a medical device • “process” – e.g., a method for treating diabetes or making a chemical compound • “article of manufacture” – e.g., an isolated DNA, Protein, or peptide, or a chemical compound. • “composition” – e.g., a pharmaceutical composition

  5. Patentability • New • Nonobvious • Utility

  6. Patent Rights and Remedies for Infringement • Right to exclude others from making, using, selling, offering for sale, or importing the patented technology • Injunction, damages in form of lost profits or reasonable royalty, tripled for willful infringement, attorneys’ fees, prejudgment interest, costs

  7. Patent Value Proposition • Defensive use of portfolio • Counter infringement charges • Prevent others from patenting • Offensive use of portfolio • DeriveRevenue • Prevent others from engaging in company’s business • Increase Valuation of Your Company • Attract investors

  8. Contents of U.S. Patent Application • Title of the Invention • Background of the Invention • Field of the Invention • Summary of the Invention • Brief Description of Drawings • Detailed Description of the Invention • Claims • Abstract • Drawings

  9. Two Prongs of Patent Strategy • Defensive Use • Patent Portfolio Building - create value for the company

  10. PatentPortfolio Philosophy • Obtain strong, enforceable patents • Build the highest quality patent portfolio

  11. Obtaining Valuable Patents • Pioneer technology or major improvement • Invention creates new industry • Invention is so new • Roadblocks • competitors must infringe patent to carry out their enterprises • Widespread applications • across many different industries • Easy to Detect Infringement • claims that are easy to read on competitors’ device or process

  12. Patent Process Overview Phase 1: Set Up Company Infrastructure for Patenting Phase 2: Invention Discovery - Patenting Decision Phase 3: Patent Preparation and Filing Phase Phase 4: Patent Prosecution Phase Phase 5: Patent Maintenance and Exploitation Phase

  13. Who is involved in the patent process? • Patent Coordinator • Patent Committee • Company Development Team • Patent Legal Counsel • Patent Examiners

  14. PATENT TIMELINE PHASE I ImplementationStrategy PHASE III PatentApplicationPreparation PHASE II Discovery ofPatentableTechnology PHASE IV PatentProsecution PHASE V PatentIssuance & Exploitation Non-U.S. Applications-PCT Applications topreserve foreign rights • Most countries other than U.S. do not have grace period • Must file for patent protection before first public disclosure, public use or certain commercial activity. U.S. provisional/nonprovisionalapplication filing date to preserve U.S. rights Patent Issuance One-year U.S. grace period Patent Exploitation Patent Prosecution Public disclosure/public use/ commercial activity involving invention 1 year 2 - 3 years 17 -18 years • Publication • 18 months after earliest filing date, either U.S. provisional, U.S. nonprovisional, or non-U.S. patent application filing • If no non-U.S. patent filings will be made, may request non-publication in U.S. until patent issuance) Deadline forfiling U.S. patent application Deadline forfiling in many countries

  15. Budgeting for Patents(U.S. Dollars, estimated) 1.U.S. Application Budgeting • Patent search cost $500-1,000 • Search report and analysis $2,500-5,000 • Prepare patent application,specification, claims, drawings, assignment of patent rights, information disclosure statement and cited documents (costs dependent on complexity of subject matter, number of different inventions, bar dates, closeness of art) $10,000-40,000 • Patent prosecution (per application) $5,000-15,000

  16. Budgeting for Patents(U.S. Dollars, estimated) 2. International Application Budgeting • Filing costs, per additional country (costs per country vary greatly) $2,000 - 30,000 • Prosecution costs $5,000 - 15,000 • Annuity fees (yearly) $200 - 1,000

  17. Practical Considerations of Patent Portfolio Development • Disclosure – must fully disclose the invention to the public in return for monopoly (is trade secret protection more effective?) • Cost – patents can be expensive to procure and maintain and are even expensive to enforce • Time – inventors and others in company must invest time in process to obtain and enforce patents • Process – patents generally require 2 - 4 years to obtain • Possible Loss of Patent Rights – company must monitor sales efforts, publications, or other events that might result in loss of patent rights

  18. Overcoming Examiner’s Rejections – Real case illustrations • Restriction Requirement • Obviousness Rejection • Enablement Rejection • Written Description Rejection

  19. Restriction Requirement • What is it? (group election, species election) • Examiner’s position • Applicant’s position • Patent Attorney’s position • Response: • Elect • without traverse • with traverse

  20. Restriction Requirement: Real Case illustration U.S. Application No. 10/893,551 Title: “Compositions of Protein Mimetics and Methods of Using Same Against HIV-1, Sars-Cov and the Like” Claim: A protein mimetic for preventing HIV entry into a host cell comprising: a. at lest two peptide strands, and b. an interstrand linker coupling the peptide strands

  21. Peptide strand: T1249 WMEWYTSLIHSLIEESQNQQEKNEQELLELDKWASLWNWF C34 WMEWDREINNYTSLIHSLIEESQNQQEKNEQELL DP178 YTSLIHSLIEESQNQQEKNEQELLELDKWASLWNWF

  22. Interstrand linker structure I

  23. Interstrand linker structure II

  24. Restriction Requirement from the Examiner: “[r]estriction to one of the following inventions is required . . . : I. Claims 1-15, 23-29, 30-37 and 45-51 are drawn to a protein mimetic comprised of two peptides covalently linked together and capable of inhibiting fusion of two separate membranes, classified in class 530, subclass 332. II. Claims 16-22 and 38-44, drawn to a method for preventing or treating HIV-1 using the pharmacological composition of Group I, classified in class 514, subclass 2.”

  25. Restriction Requirement The Examiner also stated that: “[n]o matter which group is elected, a further election of species is required. This application contains claims directed to the following patentably distinct species: Various peptidomimetics (see for example claims 3-5).”

  26. Arguments: These peptide strands are not patentably distinct species T1249 WMEWYTSLIHSLIEESQNQQEKNEQELLELDKWASLWNWF C34 WMEWDREINNYTSLIHSLIEESQNQQEKNEQELL DP178 YTSLIHSLIEESQNQQEKNEQELLELDKWASLWNWF • Contain the same amino acid fragment 638-662; and • DP178 is a partial fragment of T1249

  27. Arguments: Interstrand linkers of Formula I and II are not patentably distinct because They belong to the same genus of the compound of the formula depicted below: Formula III

  28. Successful Outcome • The arguments overcame the species election requirement. “Applicant’s election with traverse of invention I . . . is acknowledged. The traversal is on the ground(s) that peptide T1249 and C34 are not patentably distinct from the elected peptide DP179; linker I and II are not patentably distinct. This is found persuasive because of applicants’ arguments.”

  29. Overcoming Rejections under Enablement, written description, obviousness U.S. Application No. 10/999,393 “Anti-Thrombotic Thrombin Variants” Invention: (claim 1 as illustration) 1. A variant thrombin comprising an amino acid sequence having the substitutions W215A and E217A, wherein the amino acid sequence is at least 80% identical to the sequence set forth in SEQ ID NO: 3.

  30. In Office Action Feb. 21, 2006, Examiner rejected all claims • Enablement Rejection • while being enabling for the thrombin variant of SEQ ID NO:3, does not reasonably provide enablement for a thrombin variant that has substitutions W215 and E217 and is at least 80% identical to SEQ ID NO:3. • Written Description Rejection • The specification does not contain any disclosure of the function of all said polypeptides. • Obviousness Rejection • rejected as being unpatentable over Gibbs et al., 1995 in view of Arosio et al., 2000 (IDS) or Ayala et al., 2001. • Examiner asserted: suggestion and motivation to combine is based on skilled artisan’s desire to provide a thrombin variant with enhanced protein C activity and decreased fibrinogen cleavage.

  31. Argued in June 20, 2006 Response: • Enablement One of ordinary skilled in the art could practice the invention without undue experimentation (1) Nature of the invention (2) Breadth of claims (3) Guidance (4) Working Examples (5) Quantity of experimentation necessary (6) Relative skill of those in the art

  32. Argued in June 20, 2006 Response Insufficient Written Description: The working examples disclosed in the specification are representative to the function of the claimed thrombin variants. Further, the specification has detail descriptions of making and testing WE thrombin variants. Thus, Applicants had contemplated and possessed the claimed invention at the time when the application was filed.

  33. Argued in June 20, 2006 Response Obviousness • Neither reference provides any suggestion or motivation for making a thrombin variant that has two substitutions, let alone two substitutions W215A and E217A. • Claimed invention is non-obvious because of the unexpected properties. • The combination product WE has an synergy effect on reducing the release of fibrinopeptides A and B. See Tables 1 and 2 • (Fibrinogen: E217A: W215A:WE = 0.27:0.034:0.00089; Fibrin: E217A: W215A:WE = 0.15:0.053:0.0021) • Contrary to the examiner’s assertion, the combination of E217 and W215A produces a dramatically decreased, rather than enhanced, protein C activity. See Table 2 data for Protein C + TM (E217A:W215A:WE = 140:75:33).

  34. Final Office Action Aug. 24, 2006: Examiner maintained rejections • Enablement • “determining which of all polypeptides having at least 80% homology to SEQ ID NO: 3have the desired activity would require undue experimentation.” • Insufficient written description • Claim 1 fails to provide any functional limitations for the recited thrombin variants. Therefore, the polypeptides encompassed by the recited genus have any or no activity.

  35. In Final Office Action Aug. 24, 2006, Examiner maintained rejections • Obviousness • The “synergistic effect is not unexpected” and that “many enzymes have allosteric sites that act synergistically in both the activation and inhibition of the enzyme.” Citing Metzler et al (2001). • “The skilled artisan would know that it is the ratio of protein C activity to fibrinogen clotting activity (PA/FC), not the absolute protein C activity, that determines whether the action of thrombin will be primarily anti-coagulation, via the activation of protein C, or procoagulation, via cleavage of thrombin*.” (*: fibrinogen)

  36. Response to the Final Office Action: Vigorously Refuted Examiner’s points • Enablement and written description: • Amended claim 1 to require the variant thrombin W215A/E217A having the amino acid sequence set forth in SEQ ID No: 3 • Obviousness: • The invention E217A/W215A possesses unexpected synergistic properties as shown in the attached Exhibit A. • addressed and Refuted Examiner’s each point by citing scientific authority

  37. Exhibit AThe invention Shows Synergistic Results (From Tables 1 and 2, see Specification, pages 48 and 50)

  38. Comparative Data Between Cited References and the Invention (Exhibit A continued) *PA/FC here are calculated from the data shown in Tables 1 and 2. The term "PA/FC ratio" as used herein refers to the ratio of the percent of wild-type protein C activation (PA) activity remaining in a thrombin variant relative to the percent of wild-type fibrinogen clotting (FC) activity remaining in the thrombin variant. A value of PA/FC greater than 1.0 indicates that the thrombin variant has reduced procoagulant fibrinogen cleavage activity relative to the residual anticoagulant activity resulting from protein C activation.

  39. Response to the Final Office Action: Vigorously Refuted Examiner’s points • The life science/Biotechnology being in the area of unpredictable art, a synergistic effect cannot reasonably or necessarily be expected from allosteric sites. • McLennan reported that Hemoglobin has three allosteric sites, and their interactions are non-synergistic but are simply additive. See attached Abstract (Biochemistry and Molecular Biology International, Vol. 44, No. 1, pages 175-183, 1998). • Rao G.S. reported that Ascaris suumphosphofructokinase has two allosteric sites, one for fructose 2,6-biphosphate and one for AMP, and that their effects on the enzyme are additive and not synergistic. See attached Abstract (Archives of Biochemistry and Biophysics, Vol. 365, No. 2, pages 335-343(9), 1999.)

  40. Vigorously Refuted Examiner’s points in Response to the Final Office Action • Examiner shifted the basis of motivation after Applicants had responded by pointing out that the combination of E217A and W215A produced a decreased, rather than enhanced protein C activity. • if the motivation to combine the two references were really that obvious as the Examiner alleged, the Examiner would have asserted the motivation based on the skilled artisan's desire to provide an enhanced PC/PF ratio at the first place, rather than alleged “the skilled artisan's desire to provide a thrombin variant with enhanced protein C activation.

  41. Successful Outcome • Enablement and written description rejection were withdrawn for the following reasons. “The means by which the function of thrombin is regulated by its structure has been well characterized (Tsiang et al, 1995; Richardson et al, 2000). Therefore, it would not be undue experimentatikon for the skilled artisan to make and use the full scope of the recited thrombin variants; Applicants were in possession of their recited invention.”

  42. Successful Outcome • Overcame obviousness rejection • “The extent of synergy resulting from the double W215A+E217A mutation is far greater than expected. As disclosed by Applicant’s analysis in Exhibit A, filed Jan. 18, 2007, the single mutation E217A gives a PA/FC of 19.1 (Gibbs et al; Table 1), the single mutation W215A gives a PA/FC of 170 (Arosio et al; Table 1), while Applicants’ W215A_E217A thrombin variant has a PA/FC of 2865. Such dramatic synergy is far greater than expected and, as such, the unexpected results overcome the prior obviousness rejection (MPEP 716.02(c)). For these reasons, rejections of Claims 1, 2, 6, 7, 16-18, 44 and 45 under 35 USC 103(a). . . is withdrawn.

  43. Successful Outcome Patent granted and issued May 29, 2007 U.S. 7,223,583 “Antithrombotic thrombin variants” Claim 1. A protein comprising a variant thrombin, wherein the variant thrombin is at least 80% identical to the sequence set forth by SEQ ID NO: 3 and comprises the residues corresponding to Ala263 and Ala265 of SEQ ID NO: 3, and wherein the variant thrombin has a PA/FC ratio greater than 1.0.

  44. Asian Inventors Applying for U.S. Patents • Problems Asian Clients Have in Finding a Good U.S. Patent Lawyer

  45. Intellectual Property Protectionsin the U.S.: Problems Asian Clients Have in Finding a Good Patent Lawyer • Disparity with American Clients in the Quality and Amount of Attention Obtained • Language and Cultural Barriers Obstruct the Flow of Communications • Mistakenly Hiring a Poor or Incompetent Patent Counsel • Inadequacy- Counsel fails to help the client to make an informed decision. • Incompetence: Counsel fails to understand the invention, lacks the technical background to prosecute the patent application.

  46. Problems Asian Clients Have in Finding a Good Patent Lawyer – Real Examples • Counsel asks clients what to do without telling them what the options are and their implications. • Counsel misses essential information in writing patent applications. • Counsel fails to be a zealous advocate for clients, causing loss of patent coverage or potential invalidation.

  47. Taiwanese Invention 1. A heat sink, comprising: a substrate (12) having a predetermined shape and having a first pivoting portion (20) on a predetermined portion thereof; a heat scattering member (14) provided on the substrate . . . ; and a clip member (16) for securing the heat scattering member on the substrate . . . , wherein the clip member is moved between a fist positiona first position and a second position . . ..

  48. Taiwanese Invention Prior Art (Brownell) Examiner’s Novelty Rejection:

  49. Poor Patent Strategy: Surrender scope of the invention without Any Fight (1st Office Action) 1. (Currently amended): A heat sink, comprising: a substrate having a predetermined shape and having a first pivoting portion on a predetermined portion thereof; a heat scattering member . . .; and a clip member for . . ., and wherein the substrate is made of a ductile material and the first pivoting portion is mold by pressing at bottoms of opposite sides of the substrate. *The patent application states: “The substrate 12 has two pairs of first pivoting portions 20 on bottom of the opposite sides respectively.” ---- (problem: Chinese English)

  50. IPCINTELLECTUAL PROPERTY CONNECTIONS Telephone: 404-504-7688 Mobile: 651-235-7129 Facsimile: 404.365.9532 E-Mail: mingsaun@aol.com mingsaun@gmail.com Address: 299 Old County Road, Suite 28, San Carlos, CA 94070 Hsiu-Ming Saunders, Ph.D.

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