A Matter of Scale

Richard P. Feynman, recipient of the Nobel Prize in physics, said in 1959: “I would like to describe a field in which little has been done, but in which an enormous amount can be done in principle. … What I want to talk about is the problem of manipulating and controlling things on a small scale. … Atoms on a small scale behave like nothing on a large scale. … At the atomic level, we have new kinds of forces and new kinds of possibilities, new kinds of effects.” Today, nanotechnology is the science and technology of building things from the bottom up — one atom or molecule at a time. By operating at the same scale as biological processes, nanotechnology offers the capability to intervene in the blueprints of living and nonliving matter, and to recreate nature. While there is no agreement worldwide on a definition, the National Science Foundation (NSF) defines nanotechnology as: (1) research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range; (2) creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size; and (3) the ability to control or manipulate on the atomic scale. According to the NSF, federal funding for nanotechnology research and development reached approximately $961 million in 2004. An increase of 2 percent is proposed for next year. The NSF additionally projects that 2 million workers will be needed worldwide within 15 years just to support nanotechnology industries. As an enabling technology, the use of nanotechnology can be categorized by application. Yet, while some of the major applications for nanotechnology are not expected to be seen for five to 10 years, numerous products featuring the unique properties of nanoscale materials are already being used in electronic, biomedical, pharmaceutical, aerospace, cosmetic, energy, magnetic and optoelectronic, catalytic and materials applications. PATENT OFFICE Though nanotechnology has commercial prospects, its biggest liability is its novelty, coupled with its inherent multidisciplinary nature, and still-developing nomenclature. In the past, patent examiners at the U.S. Patent and Trademark Office required expertise in only one field of science to effectively research and grant competent patents. Today, nanotechnology applications challenge the Patent Office, whose examiners face the demand of being versatile across several scientific disciplines. Although the office has been taking steps on a case-by-case basis to identify areas where a new class or subclass may be needed, to date, the agency has not assigned nanotechnology a formal classification to track the number, pendency and assignment of patent applications. Nanotechnology’s cross-disciplinary diversity underlies the basic difficulty of easy classification. Therefore, responsibility for examining nanotechnology applications is spread across the agency. This process not only may result in undue delays in the review of nanotechnology-related applications, but also increases the potential for granting an overly broad or restrictive patent, or even incorrectly denying one. Even though there are no examining groups dedicated exclusively to nanotechnology, according to Vivek Koppikar, a chemical engineer and Patent Office examiner, the agency is conducting seminars and partnership meetings to educate and inform them on the nuances of nanotechnology, while simultaneously establishing a nanotechnology legal and scientific resource center. Yet, given the issues facing the Patent Office, from 1997 to 2002, the number of issued patents involving nanotechnology increased by more than 600 percent, with 90 percent of the applications coming from private corporations, some 7 percent from universities, and 3 percent from government agencies and collaborative research centers, [FOOTNOTE 1]with IBM as the leading nano-patent recipient in 2003. In nanotechnology, size is important. By manipulating matter on the atomic scale, optical, electrical, magnetic, and other characteristics of materials change. This ability to change due to size complicates the patenting of nanotechnology. While taking an existing technology and making it smaller may not result in a patent, the ability to manipulate atoms in a certain configuration creating properties with other characteristics is a patentable invention. In order to obtain a valid and enforceable patent, according to the U.S. Constitution, [FOOTNOTE 2]claims (elements) must (1) be novel; (2) be non-obvious to a person with knowledge in the field; (3) be adequately described to the public so as to demonstrate possession at time of filing; (4) be described in clear, unambiguous and definite terms; (5) enable a person with knowledge in the field to make and use it; and (6) have utility. In emerging technologies such as nanotechnology, non-obviousness is determined by the scope of the prior art. Because its processes and methods impact and interface with a wide range of applications and scientific fields such as biology, physics, chemistry, engineering, and computer science, identifying the prior art can be difficult without a centralized nanotechnology prior art database, as well as determining who is “one of ordinary skill in the nanotechnology art.” [FOOTNOTE 3] Sander Rabin, a physician-patent attorney specializing in medical nanotechnology, is head of the Convergent Technology Patent Law Group and patent counsel to Whiteman, Osterman and Hanna in Albany, N.Y. He notes that a threshold question in nanotechnology patent law is whether miniaturization to the nanoscale dimension, standing alone, will satisfy the patentability requirement of non-obviousness. For example, would a nanoscale pump that has a conventionally sized analogue be rendered obvious, and hence unpatentable because the conventionally sized analogue is disclosed in the prior art? Case law suggests that a mere difference in size would not be sufficient to distinguish a nano-sized device from a conventionally sized analogue found in the prior art. [FOOTNOTE 4] However, Dr. Rabin believes that case law is not likely to be the final word on the subject because strong arguments can be marshaled to limit the law to the facts of each case. “Resolution of the question of whether a reduction in size to the nanoscale is obvious will likely turn on an inquiry into whether the prior art that discloses the conventionally sized device also teaches a person how to make a nanoscale version of it,” according to Dr. Rabin. “If the prior art is non-enabling, i.e. if it does not teach how to miniaturize the conventional device to the nanoscale domain, then the nano-device may overcome a rejection based on overt obviousness.” Issues of lack of novelty, lack of enablement and obviousness in the setting of nanotechnology will be initially determined in the course of patent prosecution on a case-by-case basis. Still, in drafting a nanotechnology patent application, the following should be considered: � Has language been included that indicates nanoscale? � Have nanotechnology definitions been included in the specification? � Has a lexicon been employed that defines each term uniquely, thereby avoiding interpretations based on several common meanings? � If the ordinary meaning of a term is intended, have the exceptions to ordinary meaning been used deliberately and carefully? � Does the language of the specification emphasize quantitative results? � Has thought been focused on what a competitor will be blocked from making, using, or selling? � Have sets of claims of varying scope and application been drafted to overcome both rejections by the Patent Office or anticipated attempts at invalidation in future infringement litigation based upon lack of novelty, obviousness or lack of enablement? THE PATENT SYSTEM With the Patent Office facing unprecedented challenges alongside budget constraints, in October 2003, the Federal Trade Commission [FOOTNOTE 5]issued a report proposing modifications to the patent system in order to maintain a proper balance with competition law and policy to foster innovation. Some of its recommendations include the enactment of legislation to create a new administrative procedure to allow post-grant review of and opposition to patents; to employ a stricter application of the obviousness standard; to establish a preponderance of the evidence standard for validity in patent litigation; to create intervening or prior use rights; and to strengthen Patent Office’s capabilities through increased funding. In addition to these proposed reforms, the U.S. Court of Appeals for the Federal Circuit recently decided to address the issue of how to read a patent claim, an area that has generated conflicting opinions for almost a decade. In Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), the U.S. Supreme Court held that patent claim construction is an issue of law to be decided exclusively by the court, resulting in district court judges frequently conducting pretrial Markmanhearings to resolve disputes about the meaning of words or phrases in patent claims. Two competing doctrines have dominated claim construction — the claim-focused approach evaluating claim scope based on its plain ordinary meaning [FOOTNOTE 6]and the specification-focused approach [FOOTNOTE 7]in which claim scope is a function of disclosure, ignoring differentiation if conflicting with specification-driven construction. [FOOTNOTE 8] Lacking consistent guidelines, some courts have relied on dictionary definitions as their primary resource, while others on the language specifications in the patent itself. Still, from 2001 to the present, the claim-focused approach has taken precedence by expanding the plain meaning doctrine to include dictionaries, encyclopedia, and treatises. [FOOTNOTE 9] In light of the current state of the law, and in particular with nanotechnology patent applications, cautionary strategies should be maintained to minimize the risk for potential prosecution, so as not to raise the doctrine of equivalents. [FOOTNOTE 10] Precaution should also be taken in the area of patent infringement, understanding that scientific research is not exempt from patent infringement. In the case of Madey v. Duke University, 307 R.3d 1351 (Fed. Cir. 2002), the U.S. Supreme Court upheld a ruling that allowed a federally funded university to be sued for patent infringement even though its uses were solely for research, academic, or experimental purposes, thereby emphasizing that the experimental use defense does not apply to all nonprofit research. Nanotechnology is an international phenomenon that is not yet an industry, but a collection of tools and approaches that integrates with other technologies to provide new products, devices, systems, and applications. The struggle to understand, evaluate and prosecute nanotechnology patent applications is worldwide. Yet, even with this struggle, the United States, Japan, and China hold the top three spots for generating the most patent applications in nanotechnology. The lack of a harmonized patent regime exacerbates the issues surrounding the international scope of nanotechnology patents and the cost of foreign filings. U.S. inventors seeking foreign nanotechnology patents after filing a U.S. patent application (priority date), have a one-year grace period before filing under the Patent Cooperation Treaty. The treaty is an international procedure where inventors can designate the foreign countries in which they intend to file for patent protection, with most countries allowing up to 30 months from the national stage application filing date to complete application requirements. Teams of attorneys across several practice areas will need to converge to effectively understand and manage the unique legal matters of scale and multidisciplinary scope of nanotechnology. Sonia E. Miller, a Manhattan attorney and legal analyst in science and technology, is founder and president of the Converging Technologies Bar Association. If you are interested in submitting an article to law.com, please click here for our submission guidelines. FOOTNOTES: FN1Heines, M. and V. Koppikar. Patent Trends in Nanotechnology. Patent Update, September 2003. www.cepmagazine.com . FN2Article I, �8, clause 8 “Congress shall have the power ‘[t]o promote the progress of science and the useful Arts by securing for limited Times to Authors and Inventors the exclusive Right to their respective writings and Discoveries.’” FN335 U.S.C. �103. FN4 In re Rose, 220 F.2d 459, 464, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 1053, 198 USPQ 143 (CCPA 1976); and In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). FN5Federal Trade Commission pursuant to �6(f) of the Federal Trade Commission Act, 15 U.S.C. �46(f), To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy Report. FN6 Hoganas AB v. Dresser Indus., Inc., 9 F.3d 948, 951 (Fed. Cir. 1993). FN7 Abbott Labs. v. Novopharm Ltd., 323 F.3d 1324 (March 20, 2003). FN8 Toro Co. v. White Consolidated Indus. Inc., 199 F.3d 1295, 1301 (Fed. Cir. 1999). FN9 Texas Digital Systems, Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202-03 (Fed. Cir. 2002). FN10 Festo Corp. v. Shokestu Kinzoku Kogyo Kabushiki Co., Ltd., 2003 U.S. App. LEXIS 19867 (Fed. Cir. Sept. 26, 2003). 535 U.S. 722 (2002).