PATENT PROTECTION IN THE NANOTECH PLATFORM CASE LAW OF THE EPO BOARD OF APPEAL ***

1. PATENT PROTECTION IN THE NANOTECH PLATFORM CASE LAW OF THE EPO BOARD OF APPEAL *** Claudio Germinario Claudio.germinario@sib.i

2. PATENTABILITY REQUIREMENTS NOVELTY INVENTIVE ACTIVITY INDUSTRIAL APPLICABILITY ***** SUFFICIENCY OF DISCLOSURE CLARITY

3. Novelty • “The Invention is novel when: • ..at the filing date of the application …it was NOT made available to the public by any means: • Written description (literature; poster; patent), • oral disclosure (conference) • prior use (use, sell, sell offer etc).

4. Red Fluorescent Protein (RFP) -Nature, Vol. XX, pp 245-49 (2004)- In the “Macro” world This same protein will not be able to be patented anymore Red Fluorescent Protein having amino acid sequence: Met Leu Pro Ala Val Pro Pro Gln Gln Trp Ala Leu Ser Ala Gly Asn 1 5 10 15 Gly Ser Ser Glu Val Glu Val Val Pro Phe Gln Glu Val Trp Gly Arg 20 25 30 Ser Tyr Cys Arg Ala Leu Glu Arg Leu Val Asp Val Val Ser Glu Tyr .. 35 40 45 capable of emitting fluorescence with a maximum of 583nmand extinction coefficient of 22500“

5. From “Macro” to “Nano“ Nanocrystals of Red Fluorescent Protein having amino acid sequence: Met Leu Pro Ala Val Pro Pro Gln Gln Trp Ala Leu Ser Ala Gly Asn … 1 5 10 15 Gly Ser Ser Glu Val Glu Val Val Pro Phe Gln Glu Val Trp Gly Arg 20 25 30 Ser Tyr Cys Arg Ala Leu Glu Arg Leu Val Asp Val Val Ser Glu Tyr .. 35 40 45 Is this “nano-protein” novel over that disclosed in the literature ?

6. Decision T 0020/94 (Amorphous structure)  Invention Prior art NOVELTY YES

7. Decision T 0031/01 (Mineral filled Composition)  Invention prior art NOVELTY YES

8. Decision T 0509/92 (Dipeptide crystals) Aspartame Type IIa Aspartame Type III NOVELTY YES

9. One could predict that a substance claimed in nano-form, for instance as nano-crystals, should be considered novel vis-à-vis the same substance known on macro/micro-scale

10. Decision T 0915/00 (Nanocrystalline metals)  This material was recognized novel over a substantially identical material disclosed in the literature, comprising normal (macro) crystalline Nickel obtained by electrodeposition “A nanocrystal nickel material obtained by electrodepositionand having cristall size of less than 11 nm „

11. Decision T 0915/00 (Nanocrystalline Nickel)  crystals Nanocrystals Invention Prior art

12. Decision T 0006/02 (Cigarette filter)photodegradable filter TiO2 nano 100nm invention TiO2 micro 500nm Prior art

13. The THEORY Of INHERENCY 1. Nanotechnology is not simply the technology of the infinitesimally small, but the technology of the infinitesimally small accompanyed by at least one novel technical effect directly resulting from the nanosize. (chemical, physical or biological).

14. THE THEORY Of INHERENCY 2. Nanocrystals of Red Fluorescent Protein having the amino acud sequence: Met Leu Pro Ala Val Pro Pro Gln Gln Trp Ala Leu Ser Ala Gly Asn... 1 5 10 15 capable of emitting fluorescence with a maximum of 514 nm(583)and extinction coefficient of 84000 (22500)“

15. Nanocrystals of Red Fluorescent Protein having amino acid sequence: Met Leu Pro Ala Val Pro Pro Gln Gln Trp Ala Leu Ser Ala Gly Asn... 1 5 10 15 capable of emitting fluorescence with a maximum of 583 and extinction coefficient of 22500 and capable of freely permeating the cellular membrane

16. In the “Macro” The discovery of a novel property of a known substance DOES NOT reinstate the novelty of the same substance. In fact, the novel property is considered INHERENT in the known substance.

17. In the “Nano” Therefore It cannot be affirmed that the novel property exhibited by the material at nanoscale was inherent in the same material known at macroscale. The novel properties characterizing a material in nanocrystal or nanoparticle form are not retrieved on the same material at macro scale though purposely looked for.

18. Conclusion …the prefix “Nano“, unlike the prefix “Recombinant” in the biotechnology, may be able to reinstate the novelty of a known substance or material, specifically when accompanied by a novel technical effect. If this hypothesis proves valid…

19. Inventive Activity The claimed subject-matter implies an inventive activity if for the skill person it is not obviously derivable from the state of the art (e.i. Literature).

20. “DNA based integrated circuit”EP-A-1 300 892 “A method for storing information in DNA“ WO 2004/088585

21. Some Questions: * Who is the man skilled in the art? * What is the relevant technical field ? * Does the downscaling to nanosize endow the invention with an inventive step ?“

22. Some Answers The skilled person „a team of persons, each expert of a different technical field, for example gene manipulations and semiconductors. The relevant technical field. The sum of all the fieldsoverlapped by the invention.

23. Is “Downscaling“ Inventive ? In the macro: NO T 0070/99 (Analytical devices) The easy miniaturisation of a device or of an equipment is suggested by the well known industrial interest of optimizing space and materials.

24. It is well known that the top-down method has technical limits. Overtaking these limits by an alternative top-down method or by novel bottom-up methods, that means overtaking the limits of available technology could never a priori be regarded as obvious.

25. Acquired Novel Property ..regardless of the apparent obviousness of the means used to achieve the result. ...when the miniaturisation is accompanied by an unpredictable effect, the result of miniaturisation should always be regarded as inventive…

26. Decision T 0952/01 (Method of coating a substrate) .. Coating dispersion comprising solid particles of size 20-70 nm resulting in a special effect. This effect was lost for particle of size 70 e 100 nm. Essentially identical coating dispersions were disclosed in the prior art, but comprising particles of 100 –500 nm.

27. Decision T 0453/97(Antireflective coating for use in photolithography) ...an antireflective Titanium Nitride (TiN) layer having thickness between 25 and 40 nm minimized the percent of reflected radiation to less than 5%. In the prior art: Ti nitride of 100 nm with reflected percent of 30%

28. T 0453/97 Reflected 5% 25 e 40 nm

29. Reasonable expectation of success Therefore the realization of a suggestion is accompanied by a reasonable expectation of success. => No inventive activity. In traditional technical fields: Procedures are:·known, ·standardized, ·normally reproducible. => Results predictable

30. In a Pioneer Field * The procedures are NOT necessarily known, standardized and repeatable; * Minor experimantal modifications may strongly affect the expected results. ..An attempt to realize a suggestion is accompanied by a low expectation of success. => Achieving the desired result may prove inventive... Risults unpredictable

31. Decision T 0915/00(Nanocrystalline Metals) The Board affirmed that.. “...the skilled person had no obvious reason to foresee that the prior teaching could still be successfully extrapolated to structures smaller by at least two orders of magnitudes, if not with the benefit of hinsight..” “..the invention was a process for electrodepositing nanocrystalline Nickel” As many as eight prior documents “suggested” the invention, but in the context of the microcrystalline structures (> 1 micron).

32. Sufficiency of Disclosure “The patent application shall describe the invention in a manner sufficiently clear and complete for it to be carried out by the skill person.” Sufficiency of Disclosure => Repeatability of the invention

33. Interpretation Given by Case Law Sufficiency of disclosure “ The skilled person must be able to realize the invention essentially over the whole claimed ambit.” “ The realisation of the invention, (achievement of the declared effects) may not depend on chance.”

34. Generalization of Parameters On Nano-Scale ..The effect characterizing the invention depends on the size of the material and other parameters....the arbitrary generalization of sizes or parameters =>.. loss of repeatability of the invention. On Macro-Scale ... the claimed subject-matter is normally a “reasonable” generalisation of the “real invention”,

35. T 0453/97 Riflected 5% for 25 e 40 nm

36. Not Investigated Equivalents On Nano-scale …If the application comprises examples of one sole embodiment of the invention, => protection for not sufficiently investigated “equivalent” embodiments, may prove difficult to be granted

37. Equivalents T 0288/02 Invention Process of molecular beam epitaxy using as doping agent atomicNitrogen radicals. Prior artProcess of molecular beam epitaxy using as doping agent atomic o molecularNitrogen radicals. …The use of molecularNitrogen radicals was the sole described in the prior art with all experimental details and examples .. The Board considered that the embodiment “atomic radicals“ was merely speculative thus not sufficiently disclosed

38. Equivalents 2 T 915/00 Generalization: Generalization accepted only because two subsequent documents substantiated the repeatability of the process also with metals other than Nickel: otherwise no generalization accepted “NICKEL” In examples “METALS” In the claims =>

39. Metrology Analytical Methods and Tools All analytical methods, tests, assays, and analytical tools necessary to check the realization of the invention should be reproducibly described in the application Decision T 1250/01 ... The lack of analytical means for monitoring one single parameter of the invention amounts to a lack of sufficiency of disclosure of the invention.

40. Clarity (of the claims) “..which is the most suitable claim form for a nanotech invention.. ..to meet the requirement of clarity without unreasonably reducing the scope of protection? “ the claims shall define the object of the protection and shall be clear, concise and based on the description.

41. Aspects concerning Clarity · PRODUCT-BY-PROCESS CLAIMS ·FUNCTIONAL CHARACTERIZATION ·TERMINOLOGY

42. Product-by-Process. An example “..Nanocrystal metallic material obtainable by a process comprising the step of electrodepositing of the material on …”

43. Interpretation of a Product-by-Process Claim “A new process for preparing a known product is unable to restore the novelty of the obtained product “. exception: when the process is able to confer a novel feature: Polymers; extraction natural substances; combinatorial libreries

44. The Board of Appeal of EPO “…at nano-scale level, it is difficult to prove that even minor modifications in the process parameters are neutral as regard to the structural features of the obtained product..” T 0915/00, electrodeposition with a D.C.current at pulse intervals ..Versus a D.C. current in continuous.T 0753/02 deposition by sputtering versus electrodeposition.T 0950/97 specific surface topography by means of epitaxial growth.

45. Functional Characterization It is often easier and more reliable to describe (and to monitor) the novel function caused by the nano-size than to describe the structural features of the nano-material causing the novel function “Antireflective Titanium Nitride (TiN) film capable of reducing the percent of reflected radiation to less than 5%” (T 0453/97)“Chitin nanocrystallites capable of inhibiting chitinase activity”

46. The Terminology In a pioneer multidisciplinary area the technical meaning of the terms are not necessarily standardized and equally recognized by the experts of the different overlapping fields. Therefore each and every technical term used in a claim should be properly explained in the disclosure.

47. Pioneer inventions and broad claims On the point of broadness of the claims, and accordingly broadness of the protection conferred, nanotechnology may learn a lot from the lesson of biotechnology

48. THANK YOU FOR THE ATTENTION