Size matters: convincing the patent office that big things come in small packages.

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With the arrival of the biotechnology revolution a few decades ago, inventors found themselves confronted with new challenges at the patent office. Biotech inventions were not only expanding applications of science and medicine, but they were also stretching the boundaries of intellectual property law--the patentability of living matter raised the greatest controversy of all.

The biotech industry was not alone. With the deluge of computer-related patent applications that followed the arrival of the computer revolution, claims for such inventions, including business methods, soon encountered their own set of challenges. Applications filed for these technologies, fuelled by debate through landmark court decisions, had the patent offices scrambling to review and revise examination policies in order to manage their "fit" within a patent system founded and legislated on more traditional fields of scientific endeavour.

Nanotechnology has now taken centre stage and has been hailed as the next industrial revolution that will replace or change all other technologies. In contrast to the biotech industry that took tremendous strides to obtain patent protection for living matter, the nanotech industry is focusing on the molecular architecture of living and non-living matter. By operating at the molecular level, nanotechnology offers the means to manipulate and redesign ordinary matter that afford numerous advantages in applications used in many sectors of our society today, with more expected to arrive in the next five to ten years. Not surprisingly, the number of nanotechnology-related patent applications being filed at the patent office is increasing exponentially since like its predecessors, valid and enforceable patent protection will be required in order to attract investment that promotes the research and development of future technologies.

Nanotechnology for patent purposes

Nanotechnology generally refers to the engineering and manipulation of matter at the scale where size is measured between one nanometre (nm) to about 100 nm. The motivation of researchers to work with matter at the nanoscale stems from numerous advantages afforded by extraordinary changes that take place with respect to the properties of ordinary matter. This is when the laws of classical Newtonian physics are replaced by quantum mechanics and the wavelike properties of objects start to compete with their size thus affecting physical and/or chemical properties.

Chemistry is perhaps one of the best examples of how this new technology has been exploited. Take, for example, a carbon nanotube having a cylindrical shape formed from a single layer of carbon atoms and a diameter of only about one to two nm. Because of their structure, carbon nanotubes exhibit extraordinary properties in that they are 100 times stronger and six times lighter than steel, more conductive than copper and a better insulator than diamond. This makes them useful in a variety of applications. For example, with their needle-like geometry and ability to pierce a delicate plasma membrane without damaging the cell, carbon nanotubes are being used as nano-injectors for gene therapy in the delivery of DNA and RNA. Another application is seen in the manufacturing of sporting gear where, for instance, the bicycle Floyd Landis used at the 2006 Tour de France was constructed from carbon nanotubes to enhance the strength of the bicycle's frame. It weighed only one kilogram.

Patenting nanotechnology

In order for an invention to be patentable, it must be novel, non-obvious, have utility and be described so as to enable a person skilled in the art to make and practice the invention without undue experimentation. These criteria often rely on the perspective and understanding of "a person of ordinary skill in the art." Because nanotechnology-related products and processes interface with a wide range of applications and scientific fields, how one identifies the level of "ordinary skill," and other questions have transpired distinctive to patenting nanotechnology.

Novelty

One of the basic legal requirements for obtaining a patent is that the invention must be novel over the prior art. An invention lacks novelty if a single prior art reference describes, either expressly or inherently, every element of the claimed invention. "Inherency" exists when an undisclosed element is necessarily present in the prior art substance or process and would "flow as a natural consequence or characteristic" from the prior art. For example, physical properties such as melting points and solubility are examples of inherent characteristics that are generally insufficient alone to render a known substance novel and patentable.

A potential rejection likely to be encountered in a nanotechnology-related application depends on whether the claimed invention lacks novelty simply because it is a much smaller version of its previously disclosed larger counterpart. Take for example, a microscopic carbon tube having a cylindrical shape formed from several thousand layers of carbon atoms and having a diameter of only about one to two millimetres. Would a carbon nanotube having a single layer of carbon atoms and a diameter that is about a million times smaller be novel in view of the previously disclosed microscopic version? Since the wall thickness and diameter of both carbon tubes are not identical, it could be argued that every element of the carbon nanotube is not found in the prior art carbon tube and therefore, novelty exists. However, even if a prior art reference does not "expressly" disclose or specify the same elements of an invention (in this case, the wall thickness or tube diameter), a patent examiner might counter-argue that the carbon nanotube "inherently" exists in the microscopic version and therefore, lacks novelty. The basis for the argument might be that the carbon nanotube constitutes a mere change of scale of its elements.

While taking an existing technology and making it smaller may not usually result in a patentable invention, the ability to manipulate atoms into a certain configuration that produces distinctive properties can be a patentable invention. Unless an examiner could show that scaling down a larger prior art version would produce the same properties and characteristics of the nano-version, then a rejection made on the basis of inherent disclosure by the prior art version would be improper. For example, a microscopic carbon tube would not possess the enhanced thermal and electrical properties of the carbon nanotube and therefore, cannot be an inherent disclosure of the nanotube. Therefore, the question of the patentability of a known material or method manipulated at the nanoscale turns on whether new and/or improved properties emerge. Providing there is at least one new and previously unknown property between a nano-sized invention and its larger-sized prior art version, inherent anticipation cannot exist. On this basis, it is important for inventors to realize that they have a greater chance of securing patent protection for their invention if it can be shown that properties of the nanoscaled version are unique and never existed previously.

Obviousness

Yet another question in determining the patentability of a nanotechnology-related invention is whether miniaturization of a conventionally sized prior art material or method at the nanoscale level is sufficient to demonstrate non-obviousness. It has long been well established by the patent office that the mere change in the dimensions or proportions of a device are generally insufficient to form the basis of a patentable invention. The Courts have supported this principle and found that where the only difference between the prior art and a claimed invention is the relative dimensions, and the claimed invention does not perform any differently than the prior art, then no patentable distinction can be made.

If a nano-invention and its prior art analogue have similar elements, serve identical functions, operate in substantially the same way, and if undue experimentation is not involved in making the nano-invention, then an examiner might argue that a mere difference in size is obvious. Alternatively, if the difference in size imparts unique characteristics and functions to the invention due to the fundamentally different laws of physics that only exist at the nanoscale, then the obviousness dispute might be avoided. Of particular importance is if a change in proportion or arrangement of elements produces "unexpected" results that would be completely non-obvious to a person of skill in the art. Unexpected results are key to establishing non-obviousness even though an invention may be similar to the prior art in many respects. For example, because the carbon nanotube can carry a billion amps/ centimetre (2) whereas its microscopic version cannot, the high current carrying capacity of the carbon nanotube is an unexpected result and therefore, non-obvious.

Another important component in evaluating obviousness of an invention is whether a person of skill in the art would have a "reasonable expectation of success" in arriving at the invention based on the prior art. If a combination of prior art references suggests a reasonable expectation that the result would be successful, then obviousness may be found. Alternatively, if the result would not be predictable and it required excessive experimentation to achieve, then the result may prove to be inventive although suggested by the prior art.

Furthermore, even if the only difference between a nano-sized invention and the prior art is with respect to its dimensions, then non-obviousness may still be established if the prior art does not teach and/or enable one to make the nanoscale version without undue experimentation. This important principle of law was established by the Courts in In re Hoeksema in which a claim to a chemical compound was rejected by an examiner because its structure was already suggested by the prior art. In disagreement, the Court held that even though the structure may have been suggested, the claimed chemical compound may nevertheless be non-obvious if before the application was filed, no process existed to enable its production. Therefore, if the prior art fails to provide enablement for making a nano-sized invention, then non-obviousness could be established on the basis of size alone.

Sufficient disclosure

A patent application must describe how to make and use the invention without undue experimentation. If the patent application fails to meet these criteria, then either no patent will issue or the claims will have to be narrowed to correspond to the level of enablement supported by the application. In a traditional and predictable technology, such as chemical engineering, procedures for performing various techniques are usually well known and developed, standardized, and reproducible. Thus, the requirement for an enabling disclosure is more easily met for inventions derived from such technologies since less information and examples need to be provided in the application to make and use the invention. The knowledge of one skilled in the art can also be relied upon to fill in any gaps missing from an application to satisfy these legal requirements. However, since nanotechnology typically embraces multiple scientific disciplines, it may likely be less predictable and able to rely on prior art techniques and a few examples to support broad claims in an application.

Furthermore, in the U.S., the inventor is expected to comply with the "best mode requirement" by describing the preferred embodiment or optimal means of practicing the claimed invention if it materially affects the properties of the invention. If specific techniques or instruments were developed for building a nanoscale invention that were recognized by the inventor as the best way of carrying out the invention at the time the application was filed, then the best mode requirement further imposes an obligation to disclose that information to the public.

Clearly, the extent of disclosure sufficient to satisfy patentability will require careful consideration in drafting a nanotechnology-related application if the broadest available patent protection is sought.

Although the interdisciplinary nature of nanotechnology fosters creative new approaches to solving problems peculiar to a research focus, drafting applications for such inventions will require thorough consideration to avoid potential pitfalls in patent prosecution. It is therefore important that an inventor and/or patentee carefully consider how patentability requirements will be applied to nanotechnology and actively involve themselves with their patent practitioner to ensure that their ideas are properly protected. Since the primary difference between a nano-sized invention and its larger-scaled counterpart is typically its size/dimensions, it is particularly important to make clear that the invention constitutes more than a mere miniaturization of known materials and methods. Placing emphasis on how it performs differently, or yields a different useful result from the prior art is key to establishing patentability.

Elizabeth Hayes is an associate with the intellectual property law firm of Smart & Biggar/Fethertonhaugh and is a qualified U.S. and Canadian patent agent. Hayes obtained her MEng in biomedical engineering at McGill University, where she acquired a knowledge base in blood physiology, colloid/polymer chemistry, and immobilization technology due to the interdisciplinary nature of her research work.