IN RE DANE K. FISHER and RAGHUNATH V. LALGUDI
04-1465 (Serial No. 09/619,643)
United States Court of Appeals for the Federal Circuit
September 7, 2005
Stephen Walsh, Associate Solicitor, United States Patent and Trademark Office, of Arlington, Virginia, argued for the Director of the Patent and Trademark Office. With him on the brief were John M. Whealan, Solicitor, and Thomas W. Krause, Associate Solicitor.
Joseph A. Keyes, Jr., of Washington, DC, for amicus curiae Association of American Medical Colleges.
Marc S. Gold, of Washington, DC, for amicus curiae National Academy of Sciences.
Donald R. Stuart, of Indianapolis, Indiana, for amicus curiae Dow AgroSciences LLC. With him on the brief was Kenneth B. Ludwig.
Paula K. Davis, of Indianapolis, Indiana, for amicus curiae Eli Lilly and Company. With her on the brief were Steven P. Caltrider and James J. Kelley.
Michael C. Schiffer, of Irvine, California, for amicus curiae Baxter Healthcare Corporation.
Darrel C. Karl, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, for amicus curiae American College of Medical Genetics.
George C. Yu, of Emeryville, California, for amicus curiae Affymetrix, Inc.
Appealed from: United States Patent and Trademark Office Board of Patent Appeals and Interferences
Opinion for the court filed by Chief Judge MICHEL. Dissenting opinion filed by Circuit Judge RADER.
OPINION
MICHEL, Chief Judge.
Dane K. Fisher and Raghunath Lalgudi (collectively “Fisher“)1 appeal from the decision of the U.S. Patent and Trademark Office (“PTO“) Board of Patent Appeals and Interferences (“Board“) affirming the examiner‘s final rejection of the only pending claim of application Serial No. 09/619,643 (the “‘643 application“), entitled “Nucleic Acid Molecules and Other Molecules Associated with Plants,” as unpatentable for lack of utility under
I. BACKGROUND
A. Molecular Genetics and ESTs
The claimed invention relates to five purified nucleic acid sequences that encode proteins and protein fragments in maize plants. The claimed sequences are commonly referred to as “expressed sequence tags” or “ESTs.” Before delving into the specifics of this case, it is important to understand more about the basic principles of molecular genetics and the role of ESTs.
Genes are located on chromosomes in the nucleus of a cell and are made of deoxyribonucleic acid (“DNA“). DNA is composed of two strands of nucleotides in double helix formation. The nucleotides contain one of four bases, adenine (“A“), guanine (“G“), cytosine (“C“), and thymine (“T“), that are linked by hydrogen bonds to form complementary base pairs (i.e., A-T and G-C).
When a gene is expressed in a cell, the relevant double-stranded DNA sequence is transcribed into a single strand of messenger ribonucleic acid (“mRNA“). Messenger RNA contains three of the same bases as DNA (A, G, and C), but contains uracil (“U“) instead of thymine. mRNA is released from the nucleus of a cell and used by ribosomes found in the cytoplasm to produce proteins.
Complementary DNA (“cDNA“) is produced synthetically by reverse transcribing mRNA. cDNA, like naturally occurring DNA, is composed of nucleotides containing the four nitrogenous bases, A, T, G, and C. Scientists routinely compile cDNA into libraries to study the kinds of genes expressed in a certain tissue at a particular point in time.
An EST is a short nucleotide sequence that represents a fragment of a cDNA clone. It is typically generated by isolating a cDNA clone and sequencing a small number of nucleotides located at the end of one of the two cDNA strands. When an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction.
Claim 1 of the ‘643 application recites:
A substantially purified nucleic acid molecule that encodes a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5.
The ESTs set forth in SEQ ID NO: 1 through SEQ ID NO: 5 are obtained from cDNA library LIB3115, which was generated from pooled leaf tissue harvested from maize plants (RX601, Asgrow Seed Company, Des Moines, Iowa, U.S.A.) grown in the fields at Asgrow research stations. SEQ ID NO:1 through SEQ ID NO:5 consist of 429, 423, 365, 411, and 331 nucleotides, respectively. When Fisher filed the ‘643 application, he claimed ESTs corresponding to genes expressed from the maize pooled leaf tissue at the time of anthesis. Nevertheless, Fisher did not know the precise structure or function of either the genes or the proteins encoded for by those genes.
The ‘643 application generally discloses that the five claimed ESTs may be used in a variety of ways, including: (1) serving as a molecular marker for mapping the entire
B. Final Rejection
In a final rejection, dated September 6, 2001, the examiner rejected claim 1 for lack of utility under
The examiner also rejected the claimed application for lack of enablement under
On July 19, 2000, Fisher filed a notice of appeal with the Board.
The Board considered each of Fisher‘s seven potential uses but noted that Fisher focused its appeal on only two: (1) use for the identification of polymorphisms; and (2) use as probes or as a source for primers. As to the first, the Board found that the application failed to explain why the claimed ESTs would be useful in detecting polymorphisms in maize plants. Board Decision, slip op. at 14. The Board reasoned that “[w]ithout knowing any further information in regard to the gene represented by an EST, as here, detection of the presence or absence of a polymorphism provides the barest information in regard to genetic heritage.” Id., slip op. at 15. Thus, the Board concluded that Fisher‘s asserted uses for the claimed ESTs tended to the “insubstantial use” end of the spectrum between a substantial and an insubstantial utility. Id.
The Board also concluded that using the claimed ESTs to isolate nucleic acid molecules of other plants and organisms, which themselves had no known utility, is not a substantial utility. Id., slip op. at 16. Specifically, the Board noted that Fisher argued that the “claimed ESTs may be useful in searching for promoters that are only active in leaves at the time of anthesis.” Id. The Board found, however, that the application failed to show that the claimed ESTs would be expressed only during anthesis or that they would be capable of isolating a promoter active in maize leaves at the time of anthesis. Id., slip op. at 18.
Additionally, the Board addressed the remaining asserted utilities, highlighting in particular the use of the claimed ESTs to monitor gene expression by measuring the level of mRNA through microarray technology and to serve as molecular markers. The Board found that using the claimed ESTs in screens does not provide a specific benefit
Fisher timely appealed. We have jurisdiction over this appeal pursuant to
II. DISCUSSION
Whether an application discloses a utility for a claimed invention is a question of fact. In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). We consequently review the Board‘s determination that the ‘643 application failed to satisfy the utility requirement of
A. Utility
1.
Fisher asserts that the Board unilaterally applied a heightened standard for utility in the case of ESTs, conditioning patentability upon “some undefined ‘spectrum’ of knowledge concerning the corresponding gene function.” Fisher contends that the standard is not so high and that Congress intended the language of
Several academic institutions and biotechnology and pharmaceutical companies3 write as amici curiae in support of the government. Like the government, they assert that Fisher‘s claimed uses are nothing more than a “laundry list” of research plans, each general and speculative, none providing a specific and substantial benefit in currently available form. The amici also advocate that the claimed ESTs are the objects of further research aimed at identifying what genes of unknown function are expressed during anthesis and what proteins of unknown function are encoded for by those genes.
We agree with both the government and the amici that none of Fisher‘s seven asserted uses meets the utility requirement of The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point – where specific benefit exists in currently available form – there is insufficient justification for permitting an applicant to engross what may prove to be a broad field. Brenner, 383 U.S. at 534-35 (emphases added). Following Brenner, our predecessor court, the Court of Customs and Patent Appeals, and this court have required a claimed invention to have a specific and substantial utility to satisfy The Supreme Court has not defined what the terms “specific” and “substantial” mean per se. Nevertheless, together with the Court of Customs and Patent Appeals, we have offered guidance as to the uses which would meet the utility standard of Courts have used the labels “practical utility” and “real world” utility interchangeably in determining whether an invention offers a “substantial” utility. Indeed, the Court of Customs and Patent Appeals stated that “‘[p]ractical utility’ is a shorthand way of attributing ‘real-world’ value to claimed subject matter. In other words, one skilled in the art can use a claimed discovery in a manner which provides some immediate benefit to the public.” Nelson, 626 F.2d at 856 (emphasis added).4 It thus is clear that an application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the “substantial” utility requirement, an asserted use must show that that claimed invention has a significant and presently available benefit to the public. Turning to the “specific” utility requirement, an application must disclose a use which is not so vague as to be meaningless. Indeed, one of our predecessor courts has observed “that the nebulous expressions ‘biological activity’ or ‘biological properties’ In 2001, partially in response to questions about the patentability of ESTs, the PTO issued Utility Guidelines governing its internal practice for determining whether a claimed invention satisfies [a]n assessment that focuses on whether an invention is useful only in a research setting thus does not address whether the invention is in fact “useful” in a patent sense. [The PTO] must distinguish between inventions that have a specifically identified substantial utility and inventions whose asserted utility requires further research to identify or reasonably confirm. Turning to the parties’ arguments, Fisher first raises a legal issue, charging that the Board applied a heightened standard for utility in the case of ESTs. Fisher apparently bases this argument on statements made by the Board in connection with its discussion of whether the claimed ESTs can be used to identify a polymorphism. In that context, the Board stated: Somewhere between having no knowledge (the present circumstances) and having complete knowledge of the gene and its role in the plant‘s development lies the line between ‘utility’ and ‘substantial utility.’ We need not draw the line or further define it in this case because the facts in this case represent the lowest end of the spectrum, i.e., an insubstantial use. Board Decision, slip op. at 15 (emphasis added). Fisher reads the word “spectrum” out of context, claiming that the word somehow implies the application of a higher standard for utility than required by Regarding the seven uses asserted by Fisher, we observe that each claimed EST uniquely corresponds to the single gene from which it was transcribed (“underlying gene“). As of the filing date of the ‘643 application, Fisher admits that the underlying genes have no known functions. Fisher, nevertheless, claims that this fact is irrelevant because the seven asserted uses are not related to the functions of the underlying genes. We are not convinced by this contention. Essentially, the claimed ESTs act as no more than research intermediates that may help scientists to isolate the particular underlying protein-encoding genes and conduct further experimentation on those genes. The overall goal of such experimentation is presumably to understand the maize genome – the functions of the underlying genes, the identity of the encoded proteins, the role those proteins play during anthesis, whether polymorphisms exist, the identity of promoters that trigger protein expression, whether protein expression may be controlled, etc. Accordingly, the claimed ESTs are, in words of the Supreme Court, mere “object[s] of use-testing,” to wit, objects upon which scientific research could be Fisher compares the claimed ESTs to certain other patentable research tools, such as a microscope. Although this comparison may, on first blush, be appealing in that both a microscope and one of the claimed ESTs can be used to generate scientific data about a sample having unknown properties, Fisher‘s analogy is flawed. As the government points out, a microscope has the specific benefit of optically magnifying an object to immediately reveal its structure. One of the claimed ESTs, by contrast, can only be used to detect the presence of genetic material having the same structure as the EST itself. It is unable to provide any information about the overall structure let alone the function of the underlying gene. Accordingly, while a microscope can offer an immediate, real world benefit in a variety of applications, the same cannot be said for the claimed ESTs. Fisher‘s proposed analogy is thus inapt. Hence, we conclude that Fisher‘s asserted uses are insufficient to meet the standard for a “substantial” utility under Moreover, all of Fisher‘s asserted uses represent merely hypothetical possibilities, objectives which the claimed ESTs, or any EST for that matter, could possibly achieve, but none for which they have been used in the real world. Focusing on the two uses emphasized by Fisher at oral argument, Fisher maintains that the claimed ESTs could be used to identify polymorphisms or to isolate promoters. Nevertheless, in the face of a utility rejection, Fisher has not presented any evidence, as the Board well noted, showing that the claimed ESTs have been used in either way. That is, Fisher does not present either a single polymorphism or a single promoter, With respect to the remaining asserted uses, there is no disclosure in the specification showing that any of the claimed ESTs were used as a molecular marker on a map of the maize genome. There also is no disclosure establishing that any of the claimed ESTs were used or, for that matter, could be used to control or provide information about gene expression. Significantly, despite the fact that maize leaves produce over two thousand different proteins during anthesis, Fisher failed to show that one of the claimed ESTs translates into a portion of one of those proteins. Fisher likewise did not provide any evidence showing that the claimed ESTs were used to locate genetic molecules in other plants and organisms. What is more, Fisher has not proffered any evidence showing that any such generic molecules would themselves have a specific and substantial utility. Consequently, because Fisher failed to prove that its claimed ESTs can be successfully used in the seven ways disclosed in the ‘643 application, we have no choice but to conclude that the claimed ESTs do not have a “substantial” utility under Furthermore, Fisher‘s seven asserted uses are plainly not “specific.” Any EST transcribed from any gene in the maize genome has the potential to perform any one of the alleged uses. That is, any EST transcribed from any gene in the maize genome may be a molecular marker or a source for primers. Likewise, any EST transcribed from any gene in the maize genome may be used to measure the level of mRNA in a We agree with the Board that the facts here are similar to those in Brenner. There, as noted above, the applicant claimed a process for preparing compounds of unknown use. Similarly, Fisher filed an application claiming five particular ESTs which are capable of hybridizing with underlying genes of unknown function found in the maize genome. The Brenner court held that the claimed process lacked a utility because it could be used only to produce a compound of unknown use. The Brenner court stated: “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 was meant to apply to the process which yielded the unpatentable product.” 383 U.S. at 535. Applying that same logic here, we conclude that the claimed ESTs, which do not correlate to an underlying gene of known function, fail to meet the standard for utility intended by Congress. In addition to approving of the Board‘s reliance on Brenner, we observe that the facts here are even more analogous to those presented in Kirk, 376 F.2d 936, and In re Joly, 376 F.2d 906 (C.C.P.A. 1967), two cases decided by our predecessor court shortly after Brenner. In Kirk, the applicant sought to patent new steroidal compounds Second, the applicant asserted that the claimed compounds could be used by skilled chemists as intermediates in the preparation of final steroidal compounds of unknown use. Relying on Brenner, the court reasoned: It seems clear that, if a process for producing a product of only conjectural use is not itself “useful” within Id. at 945-46 (emphasis added). Therefore, the court affirmed the Board‘s rejection of the claimed compounds for lack of utility. The facts in Joly are nearly identical to the facts in Kirk. The Joly applicant filed an application claiming compounds useful as intermediates in preparing steroids that were themselves not shown or known to be useful, but that were similar in chemical structure to steroids of known pharmacological usefulness. The court adopted the reasoning of the Kirk court in its entirety and affirmed the Board‘s decision rejecting the claimed intermediates for failing to comply with We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates. 376 F.2d at 942 (emphasis added). That the Kirk and Joly decisions involved chemical compounds, while the present case involves biological entities, does not distinguish these decisions. The rationale presented therein, having been drawn from principles set forth by the Supreme Court in Brenner, applies with equal force in the fields of chemistry and biology as well as in any scientific discipline. In Brenner, the Supreme Court was primarily concerned with creating an unwarranted monopoly to the detriment of the public: Whatever weight is attached to the value of encouraging disclosure and of inhibiting secrecy, we believe a more compelling consideration is that a process patent in the chemical field, which has not been developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute. Until the process claim has been reduced to production of a product shown to be useful, the metes and bounds of that monopoly are not capable of precise delineation. It may engross a vast, unknown, and perhaps unknowable area. Such a patent may confer power to block off whole areas of scientific development, without compensating benefit to the public. . . . This is not to say that we mean to disparage the importance of contributions to the fund of scientific information short of the invention of something “useful,” or that we are blind to the prospect that what now Brenner, 383 U.S. at 535-36 (citations, quotation, and footnote omitted). Here, granting a patent to Fisher for its five claimed ESTs would amount to a hunting license because the claimed ESTs can be used only to gain further information about the underlying genes and the proteins encoded for by those genes. The claimed ESTs themselves are not an end of Fisher‘s research effort, but only tools to be used along the way in the search for a practical utility. Thus, while Fisher‘s claimed ESTs may add a noteworthy contribution to biotechnology research, our precedent dictates that the ‘643 application does not meet the utility requirement of Fisher‘s reliance on Jolles, Nelson, and Cross, cases which found utility in certain claimed pharmaceutical compounds, is misplaced. In Jolles, the applicant filed an application claiming naphthacene compounds useful in treating acute myloblastic leukemia. To support the asserted utility, the applicant presented in vivo data showing eight of the claimed compounds effectively treated tumors in a mouse model. Our predecessor court reversed the Board‘s affirmance of the final rejection for lack of utility, finding that the structural similarity between the compounds tested in vivo and the In Nelson, decided by the Court of Customs and Patent Appeals in the same year as Jolles, Nelson claimed prostaglandin compounds. The PTO declared an interference with an application filed by Bowler claiming the same compounds. The issue before the Board was whether Nelson had established utility for the claimed prostaglandins as smooth muscle stimulants and blood pressure modulators via in vivo and in vitro data, specifically, an in vivo rat blood pressure test and an in vitro gerbil colon smooth muscle stimulation test. The Board declined to award priority to Nelson, characterizing Nelson‘s tests as “rough screens, uncorrelated with actual utility [in humans].” Our predecessor court reversed, concluding that “tests evidencing pharmacological activity may manifest a practical utility even though they may not establish a specific therapeutic use.” Nelson, 626 F.2d at 856. In Cross, decided by the Federal Circuit five years after Jolles and Nelson, Iizuka filed an application claiming thromboxane synthetase inhibitors, alleged to be useful in treating inflammation, asthma, hypertension, and other ailments. When Cross filed an application claiming the same compounds two months after Iizuka, the PTO declared an interference. The dispositive issue concerned whether Iizuka‘s Japanese priority application disclosed utility for the claimed inhibitors. The Board concluded that it offered a sufficient disclosure based upon in vitro data showing strong inhibitory action for thromboxane synthetase for structurally-similar compounds in human or bovine platelet microsomes. We affirmed, reasoning: Opinions of our predecessor court have recognized the fact that pharmacological testing of animals is a screening procedure for testing Cross, 753 F.2d at 1050 (citations omitted). The facts in these three cases are readily distinguishable from the facts here. In Jolles, Nelson, and Cross, the applicants disclosed specific pharmaceutical uses in humans for the claimed compounds and supported those uses with specific animal test data, in vitro, in vivo, or both. In contrast, Fisher disclosed a variety of asserted uses for the claimed ESTs, but failed to present any evidence - test data, declaration, deposition testimony, or otherwise - to support those uses as presently beneficial and hence practical. Fisher did not show that even one of the claimed ESTs had been tested and successfully aided in identifying a polymorphism in the maize genome or in isolating a single promoter that could give clues about protein expression. Adopting the language of the Cross court, the alleged uses in Jolles, Nelson, and Cross were not “nebulous expressions, such as ‘biological activity’ or ‘biological properties’ [alleged in the application in Kirk],” that “convey little explicit indication regarding the utility of a compound.” Cross, 753 F.2d at 1048. Instead, the alleged uses in those cases gave a firm indication of the precise uses to which the claimed compounds could be put. For example, in Nelson, the claimed prostaglandins could be used to stimulate smooth muscle or modulate blood pressure in humans as shown by both in vivo and in vitro animal data. Hence, the Jolles, Nelson, and Cross courts concluded that the claimed Fisher‘s reliance on the commercial success of general EST databases is also misplaced because such general reliance does not relate to the ESTs at issue in this case. Fisher did not present any evidence showing that agricultural companies have purchased or even expressed any interest in the claimed ESTs. And, it is entirely unclear from the record whether such business entities ever will. Accordingly, while commercial success may support the utility of an invention, it does not do so in this case. See Raytheon Co. v. Roper Corp., 724 F.2d 951, 959 (Fed. Cir. 1983) (stating that proof of a utility may be supported when a claimed invention meets with commercial success). As a final matter, we observe that the government and its amici express concern that allowing EST patents without proof of utility would discourage research, delay scientific discovery, and thwart progress in the “useful Arts” and “Science.” See Fisher asserts that we should reverse the enablement rejection upheld by the Board since the Board made it contingent upon the utility rejection, which Fisher argues was not supported by substantial evidence for reasons analyzed above. The government argues to the contrary, asserting that claim 1 of the ‘643 application cannot The how to use prong of Ziegler, 992 F.2d at 1200-01 (citations omitted); see also Kirk, 376 F.2d at 942 (“Necessarily, compliance with We conclude that substantial evidence supports the Board‘s findings that each of the five claimed ESTs lacksa specific and substantial utility and that they are not enabled. Accordingly, the Board‘s decision affirming the final rejection of claim 1 of the ‘643 patent for lack of utility under AFFIRMED IN RE DANE K. FISHER and RAGHUNATH V. LALGUDI 04-1465 (Serial No. 09/619,643) United States Court of Appeals for the Federal Circuit RADER, Circuit Judge RADER, Circuit Judge, dissenting. This court today determines that expressed sequence tags (ESTs) do not satisfy 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 chromatographs, 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 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, 280 F.2d 172 (CCPA 1960), the first in a series of cases wherein the CCPA reversed several Patent Office utility rejections. Brenner, 383 U.S. at 530. 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 was 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 patentability of the product itself. Id. at 535. 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, 376 F.2d 936 (CCPA 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 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 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.” 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 still 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 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(IV) 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 evidentiary support thereof); In re Brana, 51 F.3d at 1566 (where an applicant has asserted utility in the disclosure, the 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 some 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 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
2.
3.
B. Enablement
III. CONCLUSION