Dolcera IP & Knowledge Services

1. “In re Bilski” A Threat to all Method Claims? Dolcera IP & Knowledge Services

2. Agenda In re Bilski - Background Method Claims - Frequency 101 Rejection - Frequency Research Sample Set Research Methodology Findings and Results Discussions

3. What in Blazes Is “In re Bilski”? • Bernard Bilski & Rand Warsaw filed a US patent application April 10, 1997, 08/833,892, for hedging of risks in energy commodities trading. • PTO examiner rejected all 11 initial Bilski claims because "the invention is not implemented on a specific apparatus and merely manipulates [an] abstract idea and solves a purely mathematical problem without any limitation to a practical application, therefore, the invention is not directed to the technological arts."

4. Bilski Appeals • Bilski appealed examiner's rejection to Board of Patent Appeals & Interferences BPAI. BPAI sustained the rejection of Bilski's claims, but on different grounds. "The Board concluded that Applicants' claims did not involve any patent-eligible transformation, holding that transformation of "non-physical financial risks and legal liabilities of the commodity provider, the consumer, and the market participants" is not patent-eligible subject matter." • http://www.uspto.gov/web/offices/dcom/bpai/its/fd022257.pdf

5. Bilski Appeals to BPAI • BPAI the Board held that Applicants' process as claimed did not produce a "useful, concrete and tangible result," and for this reason as well was not drawn to patent-eligible subject matter. That is, BPAI sustained a 35USC101 rejection of Bilski, claims drawn to non-patent eligible subject matter.

6. Bilski Appeals to CAFC • Bilski, not one to quit easily, appealed the BPAI ruling to the CAFC. The initial CAFC Panel, sua sponte, invoked an en banc hearing of the entire CAFC to consider the Bilski appeal. Their ruling, • 545 F.3d 943, 88 U.S.P.Q.2d 1385 (Fed. Cir. 2008), sustained the BPAI rejection of Bilski's claims, but also overturned a prior important business methods patents decision of the CAFC, State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998). In State Street, the CAFC had ruled that business methods claim is eligible for protection by a patent in the United States if it involved some practicalapplication and it produces a useful, concrete and tangible result.

7. CAFC Rules In re Bilski • Useful, concrete & tangible results no longer the test of 101 for method claims! • Must be tied to a machine or produce a transformation – machine or transformation sole test of method claims 101 eligibility! • Process claims likely swept into question!

8. Bilski Appeals to Supreme Court • Bilski has appealed to US Supreme Court. Amicus briefs in support of USSC granting certiorari include Medistem's, where they argue: • The Federal Circuit’s limiting the scope of patentable subject matter for “process” inventions in Bilski casts a cloud of uncertainty as to whether Medistem and other biotech companies can continue to protect with patents their inventions relating to methods of diagnosing causes of diseases and methods of selecting beneficial treatment protocols. "

9. Amicus Brief Process Worries • That is not simply Medistem's fear, but a not unlikely uncome of the Bilski decision according to Judge Rader's dissent against CAFC Bilski decision: • Judge Rader cogently noted that excluding patent protection for methods of using discovered biological or physiologi-cal correlations will “undermine and discourage future research for diagnostic tools.” Bilski, 545 F.3d at 1014. Medistem p3

10. Medistem’s Concerns • Although the patent at issue in Bilski claimed a business method, the Federal Circuit did not confine its adoption of the “machine-or-transformation” test to business methods. Instead, the court more broadly considered “what test or set of criteria governs the determination by the Patent and Trademark Office (‘PTO’) or courts as to whether a claim to a process is patentable under § 101 or, conversely, is drawn to unpatentable subject matter because it claims only a fundamental principle.” 545 F.3d at 952 (emphasis added). It answered that question by holding that “the machine-or-transformation test is the only applicable test and must be applied . . . when evaluating the patent-eligibility of process claims.” Medistem p5

11. If Bilski Reads on All Process Claims!? • If the machine or transformation test is the sole test of 101 eligibility of process or method claims, pharma, medtech, & diagnostics all at likely risk!

12. How Common Are Method Claims?US-A,B 2001-2009

13. How Common Are 101 Rejections of Method Claims? • Series of samples prepared in medtech, pharma, diagnostics & software patent applications • Medtech 341 US apps sampled • Pharma 325 US apps sampled • Diagnostics 364 US apps sampled • Software US apps sampled

14. Sampling of Methods Claims • US Published Apps retrieved in Public PAIR • File History screened for Office Action(s) • If FOA, was 101 rejection found? • If 101, was Bilski cited as basis?

15. Medtech Example • US20070034215A1 filed 6/27/06 • FOA issued 1/13/2009 • 101 rejection of claims 1-22 for lack of tangible product or practical application • 21 of 40 had FOA, 19 no FOA • Filing dates of no FOA as early 09/30/2005

16. In Re Bilski – Research Methodology • Medical Technology Patent Applications Mine US PAIR for Patent Applications (Published between 2007- 2008) = 700 Only Examined applications With any Rejection = 54 / 110 Note: 110 is part of 700 Only Patent Applications Examined post Oct 2008 = 37 / 54 With 35 U.S.C. §101 Rejections = 2 None - In re Bilski Citations

17. Pharma Sample • 18 / 24 had FOA, 6 no FOA • Filing dates of no FOA as early 10/22/2003 • No citations of In re Bilski

18. Diagnostics Sample • 64 US Pregrants w methods of diagnosis claims, only 1 with 101 rejection • US20060094954 filed 01/21/05 • FOA mailed 02/17/09 nearly 49 mo.! • Larger sample of 300 diagnostics methods pregrants, 12 101 rejections • Only 74 of 300 had FOA

19. In Re Bilski – Research Methodology • Diagnostics Patent Applications Mine US PAIR for Patent Applications (Published between 2005- 2007) = 200 Only Examined applications With any Rejection =128 / 200 Only Patent Applications Examined post Oct 2008 = 66 / 128 With 35 U.S.C. §101 Rejections = 22 In Re Bilski Citations = 9 / 22

20. US20060094954 101 Rejection

21. Software Patent Samples • US 2008-0201671 A1 filed 02-16-2007 • FOA issued 02-17-2009 • 101 rejection of claims 1-17 for the subject matter not being attached to a machine or undergoing a transformation • 1000 patent applications have been looked for the rejections which are randomly chosen based on range of publication date 4/1/2008 to 3/30/2009 • On the same sample set, Applications with examination date 6 months prior to Oct 2008, 40 had FOA • On the same sample set, Applications with examination date 6 months post Oct 2008, 80 had FOA, 880 had no FOA. • Filing dates of no FOA as early 5/1/2003

22. In Re Bilski – Research Methodology • Software Patent Applications Mine US PAIR for Patent Applications examined post Oct 2008) = Approx 1000 Patent Applications with 35 U.S.C. § 101 Rejections only = 100 In Re Bilski Citations = 23 / 100

23. US20050075274 Rejection

24. US20080243564 101 Rejection

25. US20080204773 Rejection

26. US20050076103 Rejection

27. Thank You!!!