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Patenting Nanotechnology Inventions: Jeremy M. Stipkala, Ph.D. IPfrontLIne.com Imagine that you have created nano-sized particles of a known drug, providing a new way to deliver that drug to a patient. Or perhaps you have pioneered sol-gel processed colloids of a metal oxide known to be a powerful catalyst. Now you want to exploit the fruits of your research and sell a product based on your invention. But first, you must protect those fruits and the further investments needed to turn your invention into a viable product, by applying for a patent. But how do you patent your nanotechnology invention when the drug or the metal oxide catalyst is already known? Software Licensing Agreements To obtain a patent, your invention must be useful, new, and not obvious.1 The nano-sized drug and colloidal catalyst are clearly useful, and they are new if no one has reported making them before. Whether those products are obvious presents a more difficult question, however, since the molecular drug and the bulk metal oxide catalyst are known. Can you patent a known material just by changing its size? When it comes to nanotechnology, the answer most likely is 'yes.' This article discusses how to show the nonobviousness of nanotechnology inventions when those inventions build on materials known in forms significantly smaller or larger than nano-sized. Section 103 of Title 35 of the United States Code describes when an invention is obvious and therefore unpatentable: 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.2 Determining whether the "subject matter as a whole would have been obvious" requires a comparison of the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of ordinary skill in the pertinent art.3 Also, so-called "secondary considerations," such as whether the claimed invention possesses unexpected results or enjoys commercial success, must be evaluated.4 The obviousness analysis applies to our hypothetical situation as follows. The pharmaceutical prior art teaches the same compound useful for the same purpose as you would use your nano-sized version—treating some disease or condition. Also, the catalysis prior art teaches your metal oxide in bulkier form for catalyzing the same reaction that you describe in your patent application. The difference with the prior art in both cases, however, is that your invention is nano-sized. Some case law suggests, however, that merely changing the size does not impart patentability. For example, merely scaling up a polymerization reaction5 or increasing the size of a package of lumber6 would not necessarily make those differently sized inventions patentable. But those situations are very different from your nanotechnology invention. Remember that we also have to look at the level of ordinary skill in the art. Was the level of skill in the pharmaceutical or catalysis art high enough so that the ordinarily skilled artisan could make your nano-sized version of the prior art? To your advantage, a product is not obvious as a matter of law unless a process for making that product is also obvious. Cases involving novel crystalline forms of drugs illustrate this. For example, in the case In re Irani, the patent applicants claimed as their invention "Crystalline anhydrous amino tri(methylene phosphonic acid) ["ATMP"]."7 The prior art taught amorphous ATMP. The prior art also taught other amino phosphonic acids in crystalline forms and the same use for those acids as disclosed by the applicants. The patent examiner at the United States Patent and Trademark Office rejected the applicants' crystalline anhydrous ATMP as obvious and therefore unpatentable in light of that prior art. On appeal, the Court of Customs and Patent Appeals (the precursor to today's Court of Appeals for the Federal Circuit) reversed, holding that the claimed form of ATMP was indeed patentable. The court stated, "we are not convinced that the references of record would lead one of ordinary skill in the art to expect that ATMP could exist in a crystalline, anhydrous form, or, assuming such an expectation, that the references would render obvious a method by which such ATMP could be produced."8 It may happen, however, that the examiner evaluating your patent application will still reject your invention as obvious. She might combine prior-art references teaching the drug or the catalyst of your invention with other prior-art references teaching processes for making nano-sized materials such as sol-gel process art. With that combination, the examiner may insist that your invention is obvious. That is, she may find that the differences between your invention and the prior art are so small that the ordinarily skilled artisan could make your invention. If that happens, you can still obtain a patent if you can show that your nanotechnology possesses properties not shared by the prior art. The Federal Circuit has provided guidance on what to do in this situation in the case In re Dillon.9 The Dillon applicant developed tetra-orthoesters as fuel additives to reduce soot formation upon combustion. One prior-art reference taught tri-orthoesters as additives to hydrocarbon fuels to dewater those fuels. Another prior-art reference taught both tri-orthoesters and tetra-orthoesters as water scavengers for hydraulic fluids. The examiner rejected the tetra-orthoester invention as obvious, because the similar structures and similar uses of the two compounds suggest that similar properties would be shared by both compounds. The Federal Circuit agreed. However, the court explained that the Dillon applicant could still obtain a patent if she had offered "a comparison of test data showing that the claimed compositions possess unexpectedly improved properties or properties that the prior art does not have[.]"10 Significantly, it is not enough to point out that a newly discovered property is not disclosed in the prior art.11 Rather, you must show that the newly discovered property does not exist in the prior-art compound or material. Therefore, it makes sense to compare your nanotechnology invention to the materials disclosed in the prior art to find different or improved properties. Your nano-sized drug particles might be administered more easily than the drug in conventional form, for example, by topical administration or inhalation. You could measure pharmacokinetics and pharmacodynamics to demonstrate more effective uptake and distribution of your nano-sized drug in vivo. Or you could show that your colloidal catalyst uses substantially less catalytic material because of its dramatically increased surface area. Such data need not be available when you file your patent application, although if you have the data, you might include it. You can develop that data after you file your patent application, once the examiner identifies the prior art closest to your invention. Then you can present the data to the examiner, knowing that "[t]here is no question that all evidence of the properties of the claimed [invention] and the prior art must be considered in determining the ultimate question of patentability[.]"12 Conclusions In sum, you can argue the patentability of your nanotechnology invention by pointing out that methods for making your invention were not obvious. Like new crystal phases, new nano-sized materials are difficult to make in the laboratory and even more difficult to manufacture in mass quantity. That is true even if general methods of nano-synthesis are known. For example, second-year chemistry majors know how to make crystals in the laboratory, but they also know that crystallization is a fickle process that does not readily yield other crystal phases or even crystals of other compounds. Similarly, the process you used to make your nano-sized invention invention -- such as the sol-gel process -- may be known, generally speaking. However, obtaining well-behaved colloids through sol-gel process chemistry can be daunting to say the least. Finding that right mix of time, temperature, and other conditions requires inventive skill and deserves a patent. If that argument does not work, you can demonstrate unexpectedly improved properties or properties not shared by the known-sized material. After all, sometimes size does matter. Footnotes 1 35 USC §§101–103. 2 35 USC §103(a). 3 Graham v. John Deere Co., 383 US 1, 17, 148 USPQ (BNA) 459, 467 (1966). 4 Id., 383 US at 17-18, 148 USPQ at 467; see also in re Dillon, infra note 9. 5 In re Rinehart, 531 F.2d 1048, 1052-53, 189 USPQ (BNA) 143, 148 (CCPA 1976). 6 In re Rose, 220 F.2d 459, 463, 105 USPQ (BNA) 237, 240 (CCPA 1955). 7In re Irani, 427 F. 2d 806, 166 USPQ (BNA) 24 (CCPA 1970). 8 Id., at 427 F.2d at 808, 166 USPQ at 26 (citing In re Cofer, 354 F.2d 664, 148 USPQ (BNA) 268 (CCPA 1966)). 9 In re Dillon, 919 F.2d 688, 16 USPQ2d (BNA) 1897 (Fed. Cir. 1990) (en banc). 10 Id., 919 F.2d at 692-93, 16 USPQ2d at 1901 (internal citations omitted). 11 Id., 919 F.2d at 693, 16 USPQ2d at 1901 (overruling In re Wright, 848 F.2d 1216, 6 USPQ2d (BNA) 1959 (Fed. Cir. 1988)). 12 Id. |
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