1. © Copyright 2005 Oblon, Spivak, McClelland, Maier & Neustadt P.C. Stephen G. Kunin Senior Counsel November 2006 Stephen G. Kunin Senior Counsel November 2006

2. Congress Courts USPTO Patent Applicants Third Parties Congress Courts USPTO Patent Applicants Third Parties

3. Authorized by Art. I., § 8, cl. 8 to enact the Patent Laws  Promote progress of useful arts by establishing quid pro quo of adequate disclosure to public of new, useful and non-obvious invention in exchange for right to exclude others from making, using, selling,,or offering to sell invention for period of years Authorized by Art. I., § 8, cl. 8 to enact the Patent Laws  Promote progress of useful arts by establishing quid pro quo of adequate disclosure to public of new, useful and non-obvious invention in exchange for right to exclude others from making, using, selling,,or offering to sell invention for period of years

4. 35 U.S.C. §§ 1-300 enacted in 1952 35 U.S.C. § 101  Subject matter eligibility  Machine, composition of matter, manufacture  process  Utility 35 U.S.C. §§ 1-300 enacted in 1952 35 U.S.C. § 101  Subject matter eligibility  Machine, composition of matter, manufacture  process  Utility

5. “Anything under the sun that is made by man” Exclusions  Abstract ideas  Laws of nature  Natural phenomena “Anything under the sun that is made by man” Exclusions  Abstract ideas  Laws of nature  Natural phenomena

6. Diamond v. Chakrabarty, 447 U.S. 303 (1980): man-made living organisms Diamond v. Diehr, 450 U.S. 185 (1981): computerized manufacturing process J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 122 S. Ct. 593 (2001): sexually & asexually reproducible plants State Street Bank & Trust v. Signature Fin. Group, Inc., 149 F.3d 1368 (Fed. Cir), cert. denied, 119 S. Ct. 851 (1999): business methods Diamond v. Chakrabarty, 447 U.S. 303 (1980): man-made living organisms Diamond v. Diehr, 450 U.S. 185 (1981): computerized manufacturing process J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 122 S. Ct. 593 (2001): sexually & asexually reproducible plants State Street Bank & Trust v. Signature Fin. Group, Inc., 149 F.3d 1368 (Fed. Cir), cert. denied, 119 S. Ct. 851 (1999): business methods

7. Left question of extension of patent process to “legislative process” Congress “best equipped to weigh competing economic, social and scientific considerations” Court “without competence” to entertain morality-laden “high policy” arguments Role is “narrow one of determining what Congress meant by the words it used in the statute; once that is done,… powers are exhausted…[U]ntil Congress takes…action, …Court must construe the language of § 101 as it is.” Left question of extension of patent process to “legislative process” Congress “best equipped to weigh competing economic, social and scientific considerations” Court “without competence” to entertain morality-laden “high policy” arguments Role is “narrow one of determining what Congress meant by the words it used in the statute; once that is done,… powers are exhausted…[U]ntil Congress takes…action, …Court must construe the language of § 101 as it is.”

8. Specific, substantial & credible utility Real world value having immediate benefit to public in currently available form 1817 Justice Story “moral” utility requirement in Lowell v. Lewis, 15 Fed. Cas. 1018, No. 8568 (C.C. Mass. 1817)(Story, J.) could be overcome with a showing of at least one moral or legal purpose for invention Specific, substantial & credible utility Real world value having immediate benefit to public in currently available form 1817 Justice Story “moral” utility requirement in Lowell v. Lewis, 15 Fed. Cas. 1018, No. 8568 (C.C. Mass. 1817)(Story, J.) could be overcome with a showing of at least one moral or legal purpose for invention

9. Federal Circuit has held that the antiquated law of utility is not law today: Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364 (Fed. Cir. 1999)  Congress never intended that patent laws displace police powers of States to promote health, good order, peace and general welfare Federal Circuit has held that the antiquated law of utility is not law today: Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364 (Fed. Cir. 1999)  Congress never intended that patent laws displace police powers of States to promote health, good order, peace and general welfare

10. Current statutes and case law make it difficult for USPTO rejections to be sustained when challenged Reliance on the 13 th Amendment to the Constitution is speculative Current statutes and case law make it difficult for USPTO rejections to be sustained when challenged Reliance on the 13 th Amendment to the Constitution is speculative

11. 1077 O.G. 24 (April 21, 1987) Notice from Commissioner Donald J. Quigg re Non- naturally Occurring Non-Human Animals are Patentable Under Section 101 Media Advisory: Facts on Patenting Life Forms Having a Relationship to Humans (April 1. 1998) 1077 O.G. 24 (April 21, 1987) Notice from Commissioner Donald J. Quigg re Non- naturally Occurring Non-Human Animals are Patentable Under Section 101 Media Advisory: Facts on Patenting Life Forms Having a Relationship to Humans (April 1. 1998)

12. Patents granted on non-human animals (USPN 4,736,866)(Harvard Mouse) Human-animal chimera applications denied Cloning patent (USPN 6,211,429)(U. of Mo.) USPA No. 09/828,876 mammalian fetus produced by cloning (U. of Mass.) Patents granted on non-human animals (USPN 4,736,866)(Harvard Mouse) Human-animal chimera applications denied Cloning patent (USPN 6,211,429)(U. of Mo.) USPA No. 09/828,876 mammalian fetus produced by cloning (U. of Mass.)

13. Brownback Amendment No. 3843, June 13, 2002 to Terrorism Risk Insurance Act of 2002 to amend § 101 to exclude humans in any stage of development failed Weldon Amendment to USPTO Appropriations Legislation remains in effect to limit spending by USPTO on granting patents on humans in any stage of development Brownback Amendment No. 3843, June 13, 2002 to Terrorism Risk Insurance Act of 2002 to amend § 101 to exclude humans in any stage of development failed Weldon Amendment to USPTO Appropriations Legislation remains in effect to limit spending by USPTO on granting patents on humans in any stage of development

14. Applicants to seek patents on man-made humans: economic incentives of patent system Third parties who file protests and requests for re-examination of patents that are believed to be morally offensive USPTO as decision-maker Applicants to seek patents on man-made humans: economic incentives of patent system Third parties who file protests and requests for re-examination of patents that are believed to be morally offensive USPTO as decision-maker

15. No bright line test Considerations apart from sections 101, 102, 103 and 112 of 35 U.S.C. Balancing interests  Merits and advantages in treating human diseases  Protecting environment  Avoiding cruelty to animals Unacceptability: societal norms Public abhorrence No bright line test Considerations apart from sections 101, 102, 103 and 112 of 35 U.S.C. Balancing interests  Merits and advantages in treating human diseases  Protecting environment  Avoiding cruelty to animals Unacceptability: societal norms Public abhorrence

16. USPTO must use its sensitive application warning system to identify patenting people applications USPTO must find ways to prevent applications from issuing in violation of Weldon Amendment USPTO is faced with difficult task in absence of clear law as basis to reject applications under other than sections 101, 102, 103 and 112 USPTO must use its sensitive application warning system to identify patenting people applications USPTO must find ways to prevent applications from issuing in violation of Weldon Amendment USPTO is faced with difficult task in absence of clear law as basis to reject applications under other than sections 101, 102, 103 and 112

17. Specifically amend § 101 to exclude patenting humans with definition of human being in any stage of development Provide general exclusion and give Director of USPTO substantive rule- making authority with reporting requirement to Congress Specifically amend § 101 to exclude patenting humans with definition of human being in any stage of development Provide general exclusion and give Director of USPTO substantive rule- making authority with reporting requirement to Congress

18. If you have any questions or comments you can reach me at:  skunin@oblon.com skunin@oblon.com  703-413-3000 (phone)  703-413-2220 (Fax) If you have any questions or comments you can reach me at:  skunin@oblon.com skunin@oblon.com  703-413-3000 (phone)  703-413-2220 (Fax)