Court Opinion

ID: 9498338
Source: CourtListenerOpinion
Date Created: 2023-08-05 17:14:52.263817+00
Date Added: 2024-06-11T17:58:46.309394
License: Public Domain

RADER, Circuit Judge,
dissenting.
This court today determines that expressed sequence tags (ESTs) do not satisfy 35 U.S.C. § 101 unless there is a known use for the genes from which each EST is transcribed. While I agree that an invention must demonstrate utility to satisfy § 101, these claimed ESTs have such a utility, at least as research tools in isolating and studying other molecules. Therefore, I respectfully dissent.
Several, if not all, of Fisher’s asserted utilities claim that ESTs function to study other molecules. In simple terms, ESTs are research tools. Admittedly ESTs have use only in a research setting. However, the value and utility of research tools generally is beyond question, even though limited to a laboratory setting. See U.S. Pat. & Trademark Off., Manual of Patent Examining Procedure (MPEP) § 2107.01 at 2100-33 (8th ed.2001, rev.Feb.2003) (“Many research tools such as gas chroma-tographs, screening assays, and nucleotide sequencing techniques have a clear, specific and unquestionable utility (e.g., they are useful in analyzing compounds).”). Thus, if the claimed ESTs qualify as research tools, then they have a “specific” and “substantial” utility sufficient for § 101. If these ESTs do not enhance research, then Brenner v. Manson, 383 U.S. 519, 86 S.Ct. 1033, 16 L.Ed.2d 69 (1966) (involving the patentability of methods for producing compounds having no known use) controls and erects a § 101 bar for lack of utility. For the following reasons, these claimed ESTs are more akin to patentable research tools than to the unpatentable methods in Brenner.
In Brenner, the Court confronted a growing conflict between this court’s predecessor, the Court of Customs and Patent Appeals (CCPA), and the Patent Office over the patentability of methods of producing compounds with no known use. This conflict began with In re Nelson, 47 C.C.P.A. 1031, 280 F.2d 172 (1960), the first in a series of eases wherein the CCPA reversed several Patent Office utility rejections. Brenner, 383 U.S. at 530, 86 S.Ct. 1033. Brenner put an end to these cases because, in the 1960s, the Court could not distinguish between denying patents to compounds with no known use and denying patents to methods of producing those useless compounds. The Court commented:
We find absolutely no warrant for the proposition that although Congress intended that no patent be granted on a chemical compound whose sole ‘utility’ consists of its potential role as an object of use-testing, a different set of rules *1380was meant to apply to the process which yielded the unpatentable product. That proposition seems to us little more than an attempt to evade the impact of the rules which concededly govern patenta-bility of the product itself.
Id. at 535, 86 S.Ct. 1033. This court’s predecessor later extended Brenner to bar patents on compounds as intermediates in the preparation of other compounds having no known use. See In re Kirk, 54 C.C.P.A. 1119, 376 F.2d 936 (1967) (rejecting intermediaries for steroids with no known use). These cases, however, share a common underpinning — a method of producing a compound with no known use has no more benefit to society than the useless compound itself.
This case is very different. Unlike the methods and compounds in Brenner and Kirk, Fisher’s claimed EST’s are beneficial to society. As an example, these research tools “may help scientists to isolate the particular underlying protein-encoding genes... [with the] overall goal of such experimentation ... presumably [being] to understand the maize genome[.]” Majority Opinion, at 1373. They also can serve as a probe introduced into a sample tissue to confirm “that the gene corresponding to the EST was being expressed in the sample tissue at the time of mRNA extraction.” Id., at 1367.
These research tools are similar to a microscope; both take a researcher one step closer to identifying and understanding a previously unknown and invisible structure. Both supply information about a molecular structure. Both advance research and bring scientists closer to unlocking the secrets of the corn genome to provide better food production for the hungry world. If a microscope has § 101 utility, so too do these ESTs.
The Board and this court acknowledge that the ESTs perform a function, that they have a utility, but proceed quickly to a value judgment that the utility would not produce enough valuable information. The Board instead complains that the information these ESTs supply is too “insubstantial” to merit protection. Yet this conclusion denies the very nature of scientific advance. Science always advances in small incremental steps. While acknowledging the patentability of research tools generally (and microscopes as one example thereof), this court concludes with little scientific foundation that these ESTs do not qualify as research tools because they do not “offer an immediate, real world benefit” because further research is required to understand the underlying gene. This court further faults the EST research for lacking any “assurance that anything useful will be discovered in the end.” These criticisms would foreclose much scientific research and many vital research tools. Often scientists embark on research with no assurance of success and knowing that even success will demand “significant additional research.”
Nonetheless, this court, oblivious to the challenges of complex research, discounts these ESTs because it concludes (without scientific evidence) that they do not supply enough information. This court reasons that a research tool has a “specific” and “substantial” utility only if the studied object is readily understandable using the claimed tool — that no further research is required. Surely this cannot be the law. Otherwise, only the final step of a lengthy incremental research inquiry gets protection.
Even with a microscope, significant additional research is often required to ascertain the particular function of a “revealed” structure. To illustrate, a cancerous growth, magnified with a patented microscope, can be identified and distinguished from other healthy cells by a properly trained doctor or researcher. But even today, the scientific community *1381still does not fully grasp the reasons that cancerous growths increase in mass and spread throughout the body,1 or the nature of compounds that interact with them, or the interactions of environmental or genetic conditions that contribute to developing cancer. Significant additional research is required to answer these questions. Even with answers to these questions, the cure for cancer will remain in the distance. Yet the microscope still has “utility” under § 101. Why? Because it takes the researcher one step closer to answering these questions. Each step, even if small in isolation, is nonetheless a benefit to society sufficient to give a viable research tool “utility” under § 101. In fact, experiments that fail still serve to eliminate some possibilities and provide information to the research process.
The United States Patent Office, above all, should recognize the incremental nature of scientific endeavor. Yet, in the interest of easing its administrative load, the Patent Office will eliminate some research tools as providing “insubstantial” advances. How does the Patent Office know which “insubstantial” research step will contribute to a substantial breakthrough in genomic study? Quite simply, it does not.
In addition, this court faults Fisher for not presenting evidence of utility showing that the claimed ESTs “have been used in the real world.” To the contrary, this court misapprehended the proper procedure. Fisher asserted seven different utilities. The Board rejected two of these assertions outright as “insubstantial.” See Ex parte Fisher, App. No.2002-2046, slip, op at 14-16 (Bd. Pat.App. and Int.2004) (acknowledging that the ESTs may be able to detect “the absence of a polymorphism” and “to isolate nucleic acid molecules of other plants and organisms[,]” but finding such utilities are not “substantial” even if the ESTs can perform them). This summary dismissal deprived Fisher of any chance to proffer evidence. Rather than fault Fisher for not presenting evidence it was prevented from offering, this court should instead observe that the Board did not satisfy its burden of challenging Fisher’s presumptively correct assertion that the ESTs were capable of performing those functions. See MPEP § 2107.02(PV) at 2100-40 (noting that the initial burden is on the office to establish a prima facie case as to lack of utility and to provide eviden-tiary support thereof); In re Brana, 51 F.3d 1560, 1566 (Fed.Cir.1995) (where an applicant has asserted utility in the disclosure, the Patent Office has the initial burden of challenging this presumptively correct assertion of utility).
Abandoning the proper legal procedure, the Board reasoned that the molecules studied with these ESTs showed no particular use, therefore the ESTs themselves also lacked a utility. In so ruling, the Board did not reject Fisher’s utilities on the basis that the ESTs were unable to perform the purported utilities. Thus, the Board did not establish a prima facie challenge to the ESTs’ ability to perform these two utilities. Without anything to rebut, Fisher had no obligation or opportunity to provide evidence in rebuttal. Thus, I respectfully disagree with this court’s conclusion that the Board’s decision can be affirmed on the basis that Fisher did not supply evidence of the ESTs’ ability to perform the asserted utilities.
In truth, I have some sympathy with the Patent Office’s dilemma. The Office needs *1382some tool to reject inventions that may advance the “useful arts” but not sufficiently to warrant the valuable exclusive right of a patent. The Patent Office has seized upon this utility requirement to reject these research tools as contributing “insubstantially” to the advance of the useful arts. The utility requirement is ill suited to that task, however, because it lacks any standard for assessing the state of the prior art and the contributions of the claimed advance. The proper tool for assessing sufficient contribution to the useful arts is the obviousness requirement of 35 U.S.C. § 103. Unfortunately this court has deprived the Patent Office of the obviousness requirement for genomic inventions. See In re Deuel, 51 F.3d 1552 (Fed.Cir.1995); Martin J. Adelman et al., Patent Law, 517 (West Group 1998) (commenting that scholars have been critical of Deuel, which “overly favored patent applicants in biotech by adopting an overly lax nonobviousness standard.” (citing Anita Varma & David Abraham, DNA Is Different: Legal Obviousness and the Balance Between Biotech Inventors and the Market, 9 Harv. J.L. & Tech. 53 (1996))); Philippe Ducor, The Federal Circuit and In re Deuel: Does §103 apply to Naturally Occurring DNA?, 77 J. Pat. & Trademark Off. Soc’y 871, 883 (Nov.1995) (“The Court of Appeals for the Federal Circuit could have formulated its opinion in only one sentence: ’35 U.S.C. § 103 does not apply to newly retrieved natural DNA sequences.” ’); Philippe Ducor, Recombinant Products and Nonobviousness: A Typology, IS Santa Clara Computer and High Tech. L.J. 1, 44-45 (Feb.1997) (“This amounts to a practical elimination of the requirement for nonobviousness for these products, even when all the information necessary to discover them is previously available.”); see also over fifty additional articles critical of Deuel in the “Citing References” tab for Deuel on Westlaw. Nonetheless, rather than distort the utility test, the Patent Office should seek ways to apply the correct test, the test used world wide for such assessments (other than in the United States), namely inventive step or obviousness.
Thus, for the foregoing reasons, I would find that Fisher’s asserted utilities qualify the claimed ESTs as research tools useful in the study of other molecules. Because research tools provide a cognizable benefit to society, much like a microscope, the ESTs claimed here have “utility” under § 101. In addition, the enablement rejection should also be reversed because it was a consequence of the finding of lack of utility.

. ESTs have already been used to advance cancer research well beyond what is achievable using microscopes alone. See Andy J. Minn, Genes That Mediate Breast Cancer Metastisis To Lung, Nature, July 28, 2005 at 518-24 (discussing research to identify genes that mark and mediate breast cancer metastisis to the lung).