Staking A Claim In The Nanoworld

Introduction

Nanotechnology is an emerging field that concerns the development and use of compositions of matter that generally have a size of between 1 and 100 nanometers, a "nanometer" being one billionth of a meter. At such small sizes, the compositions take on novel and potentially useful properties. Examples of these compositions include: smart molecules capable of targeting and eliminating infection and disease; carbon nanotubes and nanowires (potentially useful for advanced composites, electrical circuitry, systems for targeted delivery of pharmaceutical agents, and hydrogen storage mediums to power fuel cells); quantum dots; and high density DNA storages devices.

Governments around the world are pumping $2 billion a year into nanotechnology research. In December, 2003, the Twenty-first Century Nanotechnology Research and Development Act (S. 189) was made law, authorizing approximately $3.7 billion, allocated over four year period starting October, 2004, for federal nanotechnology research and development. By 2015, nanotechnology is projected to have an economic impact of $1 trillion. [1] Intellectual property rights, including patents, will be crucial in ensuring an economic return.

From a patenting standpoint, unique issues arise in the Nanoworld. This article is intended to provide a guide to understanding these issues and obtaining the best protection possible for nanotechnology inventions.

Examination of Nanotechnology Patents

Recent issues have emerged in the examination of nanotechnology inventions by the United States Patent and Trademark Office ("PTO"). [2] One issue is whether a specific nanotechnology examining group should be created. Although classification of certain nanotechnology is straightforward and fits well into current categories, a significant amount of nanotechnology is interdisciplinary, and resists classification into any one examining group. [3] The lack of a nanotechnology examining group could result in lengthier prosecutions and eventually a backlog of nanotechnology patent applications. [4] Further, in the past, the lack of specific examining groups for other pioneering technologies, such as biotechnology and e-commerce, may have resulted in patents that were overly broad, [5] thereby unsettling their respective industries and creating at least some degree of skepticism as to whether patents were appropriate for these industries at all.

Another issue is whether patent examiners have the proper training in nanotechnology. [6] In view of the numerous complex nanotechnology patents that have already issued, it seems that the PTO has at least some degree of expertise. Nonetheless, considering the rapid pace at which the field is evolving, examiner training will remain an issue that must be carefully watched.

Nanotechnology Patent Prosecution Guidelines

Title 35 of the United States Code requires that an invention have utility, [7] novelty [8] and be nonobvious [9] in order to be patentable. In addition, the application must meet written description, enablement and best mode requirements.[10]

Utility: 35 U.S.C. §101

Utility requires that the invention be a "new and useful process, machine, composition of matter, or new and useful improvement thereof." 35 U.S.C. §101. The drafter of the patent application must demonstrate that the invention: (1) is operable and capable of use; and (2) achieves some minimum human purpose that is not illegal, immoral or contrary to public policy. [11]

Although the threshold for establishing utility is not high, [12] the PTO does require assertion of a specific, substantial and credible utility. [13]

With nanotechnology inventions (which in view of the youth of the field itself may comprise pioneering inventions more often than in some other fields), the need to ensure that a specific, substantial and credible utility is asserted at the time of filing is particularly acute. Given that the PTO has apparently increased utility scrutiny with respect to pioneering biotechnology inventions, [14] the utility of nanotechnology inventions may also be subject to higher PTO scrutiny. Therefore, one should assert at least one specific and substantial utility that is credible, instead of mere speculative uses. For example, assume certain secondary and tertiary structures of DNA molecules may be useful to make nanoscale computer chips, although their only demonstrated utility is to conduct electricity. At least the conductor use should be disclosed to satisfy the utility requirement. The more speculative computer chip use may also be disclosed, but should not be relied upon, by itself, to satisfy the utility requirement.

Novelty and Nonobviousness: 35 U.S.C.§§ 102 & 103

An invention must also be novel and nonobvious. Although a recently discovered property of a known nano-composition may appear to be "novel," if it is merely an inherent property of that composition, it will not be deemed patentable. [15] For example, assume certain known nanoscale protein complexes are found to be useful as molecular motors because of their controlled mechanical motion. If these protein complexes always and necessarily act as molecular motors, they would inherently anticipate a broad claim to the complexes as molecular motors. Therefore, care must be taken to ensure that the claimed invention is not merely an inherent property of a known composition.

The obviousness of making something smaller is also a key issue, since many nanotechnology inventions involve a reduction in size from known structures at the larger micrometer range. Under a classical analysis, a mere change in the size of a previously known structure is not enough to convey patentability. [16] However, if size plays some critical role in its function or utility, as is often the case with nanotechnology, arguments may be made in favor of patentability. [17] This is particularly true if the change in size is associated with the classic indicia of nonobviousness, such as commercial success, unexpected results, long felt but unsolved needs, and failure of others. [18] Accordingly, care should be taken when preparing a patent application to make sure that any superior or critical results as well as the classic secondary indicia of non-obviousness are disclosed in the specification --preferably in a compelling fashion-- to help rebut (or even preempt) an obviousness rejection by the PTO. For example, assume micrometer-sized titanium dioxide crystals have previously been used in sun block, causing it to appear white. Assume further that nanometer-sized titanium dioxide crystals are discovered and used to provide an effective sun block that appears advantageously clear. In this case, it can be argued that the reduction in size provides a superior and patentable result, that is, a clear sun block.

Written Description and Enablement: 35 U.S.C. § 112

The first paragraph of §112 requires that the subject matter claimed be adequately described in the patent specification. This requirement serves as a quid-pro-quo: disclosing the invention to the public in exchange for a limited monopoly. [19] To meet the requirements of § 112, the application must "describe the claimed invention so that one skilled in the art can recognize what is claimed." [20] A disclosure should correlate a claimed function with a known structure. [21]

Providing an adequate disclosure can be problematic for nanotechnology inventions because of their complexity, unpredictability and lack of full development. While being the first to file and obtain a patent in a pioneering field can secure a stronghold on the market, the relative dearth of prior art means that the hypothetical "person of ordinary skill," against whom the adequacy of the disclosure is measured, will bring very little to the table. Thus, inventors must take even more care than usual to ensure that they describe a real invention, rather than just a tenuous or speculative idea.

Section 112, first paragraph, also requires that the specification enable one skilled in the art to make and use the claimed invention without "undue experimentation." [22] Several factors are traditionally considered in determining whether a disclosure is enabling, including, but not limited to,: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. [23] Nanotechnology, as noted above, is likely to be considered a complex, unpredictable and undeveloped art, and thus the lack of working examples, test data, and/or direction in a patent application may raise an issue of inadequate enablement. [24] Accordingly, inventors should ensure that the latter be included in the patent application, to the extent possible, to comply with Section 112.

Conclusion

There is much to be gained in patenting inventions in the emerging field of nanotechnology, where a tremendous amount of time and money is now being invested. This puts a particular onus on inventors and patent practitioners to ensure that the issues of utility, novelty, nonobviousness, written description and enablement are fully addressed so that valid and enforceable patents may be obtained.

1. Baraby J. Feder, March 15, 2004 nytimes.com>
2. Vivek Koppikar et al., Current Trends in Nanotech Patents: A View From Inside the Patent Office, 1 Nanotech. Law & Bus. 1, 4 (2004).
3. See Timonty Hseih et al., United States: Thinking Small: The Patent Office Grapples with Nanotechnology, IP Law & Bus. (July 2003).
4. Id.
5. Id.
6. Testimony of Alan Marty, for the Committee on Science of the U.S. House of Representatives, March 19, 2003, http://www.house.gov/
7. 35 U.S.C. § 101 (2004).
8. 35 U.S.C. § 102 (2004).
9. 35 U.S.C. § 103 (2004).
10. 35 U.S.C. § 112 (2004). Compliance with "best mode," which requires inventors to disclose the best way they know of carrying out their invention, does not raise any significant issues unique to nanotechnology inventions, and thus will not be addressed specifically herein.
11. 1 Donald S. Chisum, Chisum on Patents §4.01 (2003).
12. See Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1366 (Fed. Cir. 1999), ("The threshold of utility is not high: An invention is 'useful' under section 101 if it is capable of providing some identifiable benefit").
13. MPEP § 2107.01 (8th Ed. Feb. 2003).
14. Id.
15. Cf., Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003).
16. See, e.g., In re Rinehart, 531 F.2d 1048, 1053 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled").
17. See Pederson v. Stewart-Warner Corp., 400 F.Supp. 1262, 1268 (N.D. Ill. 1975) aff'd 536 F.2d 1179 (7th Cir. 1976) ("Changes of size and shape, without especial [sic] functional significance, are not patentable") (emphasis added); Schlaich v. Robertson, 26 F.2d 681, 685 (D. Md. 1928) ("That which is involved in the patents in suit is not merely a reduction in size. The new tubing is effective only by reason of its size. The reduction . . . converted failure into success, and involved something more than a matter of degree. A result of this kind may constitute invention."); see also, 2 Donald S. Chisum, Chisum on Patents §5.03[5][a] (2003) (Comparative Utility as Evidence of Nonobviousness).
18. Graham v. John Deere Co., 383 U.S. 1, 17 (1966)
19. See, Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002).
20. Id. at 968.
21. See e.g., Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (In matters relating to biotechnology, the court required the precise identification of a nucleotide sequence, invalidating claims based on the inventors' mere functional disclosure.)
22. 35 U.S.C. § 112 (2004); see also In re Wands, 858 F.2d 731 (Fed. Cir. 1988).
23. Wands, 858 F.2d at 737.
24. MPEP § 2164.02 (8th ed. Feb. 2003).