1. PATENTS Elements of Patentability Victor H. Bouganim WCL, American University

2. Victor H. Bouganim, WCL, American University, Spring 2001 Elements of Patentability F Patentable Subject Matter F Utility F Novelty F Non- obviousness F Enablement

3. Victor H. Bouganim, WCL, American University, Spring 2001 Patentable Subject Matter 35 U.S.C. Sec. 101 “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

4. Victor H. Bouganim, WCL, American University, Spring 2001 Diamond v. Chakrabarty U.S. Supreme Court (1980) F Dr. Chakrabarty artificially created an oil-eating bacterium and filed a patent application. F The PTO rejected the claim for the bacterium itself on the grounds it was living matter, and thus outside the scope of 35 U.S.C. Sec. 101. F Issue: Are living organisms patentable? –The Court finds that the bacterium falls under the broad language of the statute –Further, the Court stated that any public policy concerns should be addressed by Congress.

5. Victor H. Bouganim, WCL, American University, Spring 2001 Parke-Davis & Co. v. H.K. Mulford Co. S.D.N.Y. (1911) F The inventor discovered how to isolate “adrenaline” - a purified substance of significant medical use from the suprarenal glands of animals. F The inventor patent claim covered any substance which possesses the physiological characteristics of the glands. F Issue: whether the invention was patentable subject matter. –In finding the invention patentable, Learned Hand observed that “The line between different substances and degrees of the same substance is to be drawn rather from the common usage of men than from nice considerations of dialectic…”

6. Victor H. Bouganim, WCL, American University, Spring 2001 CLASS DISCUSSION F Should the first person to purify a natural product to a certain degree be entitled to a patent on the purified product itself? Or only on purified products produced by that method? F Is there ever a valid concern about allocating exclusive ownership rights to certain types of inventions?

7. Victor H. Bouganim, WCL, American University, Spring 2001 Patenting “Abstract Ideas” F Patents are intended to cover “devices” or physical things in the useful arts, not abstract, speculative, or esoteric matters. F A patent issues only if the invention achieves a tangible, practical result. F E.g., a hypothetical attempt by Einstein to patent the formula E=mc 2 -- not patentable. F Excluded: –advances in the social sciences –advances in business management –articulation of a scientific principle

8. Victor H. Bouganim, WCL, American University, Spring 2001 Utility 35 U.S.C. Sec. 101 “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…”

9. Victor H. Bouganim, WCL, American University, Spring 2001 Brenner v. Manson U.S. Supreme Court (1966) F The PTO found Manson’s process for making certain steroids unpatentable due to a failure to disclose any utility for the steroids. F Issue: whether a product or process is patentable if it has no known uses or is useful only in that it may be the subject of scientific research. –The Court found Manson’s process unpatentable because it was not “useful.” F This case represents the peak of the Court’s interpretation of the utility doctrine. –Subsequent cases and PTO guidelines are less strict.

10. Victor H. Bouganim, WCL, American University, Spring 2001 Utility Analysis General Utility F focus on whether the invention is operable or capable of any use Specific Utility F focus on whether the invention works to solve the problem it is designed to solve Beneficial or Moral Utility F focus on whether the intended purpose of the invention has some minimum social benefit, or is not harmful

11. Victor H. Bouganim, WCL, American University, Spring 2001 CLASS DISCUSSION F What harm is there in granting a patent on an invention later shown to be useful? F Should protection be granted to a product without “utility” which encourages another inventor to take a further step in creating a commercially useful item? F Would the existence of a market demand for the “intermediate” products at issue change the result of this case?

12. Victor H. Bouganim, WCL, American University, Spring 2001 Novelty and Statutory Bars Novelty and Statutory Bars 35 U.S.C. Sec. 102 A person shall be entitled to a patent unless -- (a) Novelty (b) Statutory Bars …….. (e) Secret Prior Art (g) Priority

13. Victor H. Bouganim, WCL, American University, Spring 2001 The Nature of Novelty 35 U.S.C. Sec. 102(a) “A person shall be entitled to a patent unless-- (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent…”

14. Victor H. Bouganim, WCL, American University, Spring 2001 Rosaire v. National Lead Co. Fifth Circuit (1955) F The patents at issue related to methods of prospecting for oil or other hydrocarbons. F Defendant argued that the same alleged inventions were known and extensively used in field before any dates asserted by the Plaintiff. F Plaintiff argues that this use and knowledge does not fall under 102(a) because the public was not given “the benefit of the experimental work.” F The court held the patent invalid, finding no requirement in the statute of public knowledge with regard to the prior use.

15. Victor H. Bouganim, WCL, American University, Spring 2001 Statutory Bars: Publications 35 U.S.C. Sec. 102(b) “A person shall be entitled to a patent unless-- (b) the invention was…described in a printed publication in this or a foreign country…more than one year prior to the date of the application for patent in the United States…”

16. Victor H. Bouganim, WCL, American University, Spring 2001 In re Hall C.A.F.C. (1986) F The PTO rejected Hall’s claims because they referenced a printed publication dated more than one year prior to his filing date. F Hall contended that the publication, a doctoral thesis, was not within the scope of sec. 102(b) because it was inaccessible to the public as a result of not being shelved in the university library. F Issue: whether public accessibility determines if a reference constitutes a printed publication. –The court affirmed the rejection, finding that affidavits from the library established the thesis’ availability for general use more than one year prior to the critical date.

17. Victor H. Bouganim, WCL, American University, Spring 2001 Statutory Bars: Public Use 35 U.S.C. Sec. 102(b) “A person shall be entitled to a patent unless-- (b) the invention was…in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States…”

18. Victor H. Bouganim, WCL, American University, Spring 2001 Egbert v. Lippmann U.S. Supreme Court (1881) F In a suit for patent infringement, Lippman argued in his defense that the original patentee had permitted the corset steels to be “in public use” long before he patented them. F Issue: whether an inventor put his invention “in public use” by giving it or selling it to another to be used without limitation or restriction. –Whether the use of an invention is public does not depend upon the number of persons to whom its use is known or the number of articles publicly used. –The Court found there was public use of the corset steels.

19. Victor H. Bouganim, WCL, American University, Spring 2001 The Experimental Use Exception F A public use that is primarily experimental will not trigger the one year statutory period of section 102(b). F The primary purpose must be experimental, not commercial exploitation or development of a market.

20. Victor H. Bouganim, WCL, American University, Spring 2001 City of Elizabeth v. Pavement Co. U.S. Supreme Court (1877) F While developing a process for laying down wooden pavement, Nicholson experimented by laying down pavement on a public road. F Issue: whether public experimentation places the invention within the statutory meaning of “public use.” –Street pavement cannot be experimented upon satisfactorily without public use. –Nicholson never let his invention beyond his control. –The Court held the patent not barred under sec. 102(b) because of the experimental use e xception.

21. Victor H. Bouganim, WCL, American University, Spring 2001 Priority Rules and the First to Invent 35 U.S.C. Sec. 102(g) “An inventor shall be entitled to a patent unless -- (g) before the applicant’s invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it. In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.”

22. Victor H. Bouganim, WCL, American University, Spring 2001 Invention REDUCTION TO PRACTICE CONCEPTION

23. Victor H. Bouganim, WCL, American University, Spring 2001 Invention Terminology Conception The formation in the inventor’s mind of a definite and permanent idea of a complete invention that is thereafter applied in practice Reduction to Practice F The physical construction of an inventor’s into actual working form F Constructive reduction means filing a patent application

24. Victor H. Bouganim, WCL, American University, Spring 2001 Griffith v. Kanamaru C.A.F.C. (1987) F This case involved a patent inference involving the invention of an aminocarnitine compound, useful in the treatment of diabetes. F Issue: whether the applicant, Griffith, established “reasonable diligence” to excuse his inactivity prior to reduction to practice. F The court rejected Griffith’s justifications for the inactivity: waiting for funding from outside the university and waiting for a certain student to matriculate in order to assist with the project. F The court held that Griffith failed to establish reasonable diligence.

25. Victor H. Bouganim, WCL, American University, Spring 2001 Nonobviousness 35 U.S.C. Sec. 103 “(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains…”

26. Victor H. Bouganim, WCL, American University, Spring 2001 Non-obviousness Considerations (1) The scope and content of the prior art (2) The differences between the claimed invention and the prior art (3) The level of ordinary skill in the art (4) Secondary considerations

27. Victor H. Bouganim, WCL, American University, Spring 2001 Non-obviousness Secondary Considerations F Commercial success F Long-felt but unresolved need F Failure of others to make the invention

28. Victor H. Bouganim, WCL, American University, Spring 2001 Graham v. John Deere Co. U.S. Supreme Court (1966) F Issue: whether the determination of the non-obviousness of a claimed invention as to prior art requires a case-by-case analysis of the scope and content of the prior art, the differences between the prior art and claims at issue, and the level of ordinary skill in the pertinent art. F The Patent Act of 1952 added the statutory non-obviousness requirement, which was a codification of judicial precedent. F The non-obviousness analysis involves examination of the factors listed above as well as several secondary considerations. F Under this analysis, the Court found the patents at issue in this case to be obvious, and thus invalid.

29. Victor H. Bouganim, WCL, American University, Spring 2001 In re Vaeck C.A.F.C. (1991) F Based on a combination of prior art references, the PTO rejected as obvious the claimed invention of genetic engineering for production of proteins toxic to insects. F Court’s analysis: –(1) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and –(2) whether the prior art would have revealed that in so making or carrying out, those of ordinary skill would have a reasonable expectation of success. F The court found no suggestion in the prior art and no reasonable expectation of success.

30. Victor H. Bouganim, WCL, American University, Spring 2001 Describing and Enabling the Invention F A invention must be described sufficiently well that one of ordinary skill in the art an, relying on the description in the patent, make and use the invention. Description Objectives F Prove to the world that the applicant was in fact in possession of the invention at the time of the application F Enable those skilled in the relevant art to make and use the invention