Prior Art References Research Articles

Trustees of Columbia Univ. in City of New York v. Illumina, Inc. United States Court of Appeals of the Federal Circuit, 2021 No. 2019-2302, 2021 WL 317661 (nonprecedential)

Trustees of Columbia Univ. in City of New York v. Illumina, Inc. United States Court of Appeals of the Federal Circuit, 2021 No. 2019-2302, 2021 WL 317661 (nonprecedential)

Immunex Corp. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2020 964 F.3d 1049

Immunex Corp. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2020 964 F.3d 1049

Looking at Patent Law: Patenting a Unitized Regenerative Fuel Cell System for Space Energy Storage Applications--A Case Study

In this installment of the “Looking at Patent Law” series, we present a case study of the prosecution of a “Unitized Regenerative Fuel Cell” patent invented by Kenneth A. Burke, an engineer at the NASA Glenn Research Center. This case was chosen to coincide with the “Electrochemistry for Space Exploration” focus of this issue of Interface. The case illustrates national security screening of patent applications by the United States Patent & Trademark office and review by the Department of Defense. Additionally, the article illustrates the combination of prior art references as the basis for an obviousness rejection of an invention. The article notes that the examiner must establish a teaching-motivation-suggestion to combine prior art references to establish an obviousness rejection. With this case study, we hope to demystify the patent prosecution process and better prepare electrochemical and solid state scientists, engineers, and technologists to interact with their patent counsel regarding their inventions.

Prior Art in the District Court

This Article is an empirical study of the evidence district courts rely upon when invalidating patents. To construct our dataset, we collected every district court ruling, verdict form, and opinion (whether reported or unreported) invalidating a patent claim over a six-and-a-half-year period. We then coded individual invalidity rulings based on the prior art supporting the court’s decision, observing 3320 invalidation events relying on 817 distinct prior art references. The nature of the prior art relied upon to invalidate patents is relevant to two distinct sets of policy questions. First, this data sheds light on the value of district court litigation as an error- correction tool. As prior work has shown, the public interest in revoking erroneous patent grants depends on the reason those grants were undeserved. Second, this data sheds light on the feasibility of discovering invalidating prior art during patent examination. Depending on the ease of finding the relevant prior art, it may or may not be cost effective to replace patent litigation with a different approach to error correction, such as investing more effort in examination-stage scrutiny. The conclusions here are mixed. On one hand, invalidations for lack of novelty bear many indicia of publicly beneficial error correction. Anticipation based on obscure prior art appears to be quite rare. When it comes to obviousness, however, a significant number of invalidations rely on prior art that would have been difficult or impossible to find at the time of invention. This complicates—though does not necessarily refute—the traditional view that obviousness challenges ought to be proactively encouraged.

Adverse Inference of Intent to Deceive USPTO As a Sanction for Litigation Misconduct

In a July 2017 decision, Regeneron Pharms., Inc. v. Merus N.V. (“Regeneron II”), a divided panel of the U.S. Court of Appeals for the Federal Circuit affirmed the Southern District of New York’s judgment that Regeneron’s asserted patent was unenforceable for inequitable conduct in its prosecution. The full Circuit denied rehearing en banc by a 10-2 vote in December 2017. The notable and troubling aspect of Regeneron II is the panel majority’s approval of the district court’s imposition of a sanction against the patentee for its misconduct in the infringement litigation with Merus. Much of that litigation misconduct involved Regeneron’s failure (having waived attorney-client privilege) to produce documents requested during discovery that pertained to its prosecuting attorneys’ decision not to submit certain prior art references to the USPTO. The Federal Circuit was not mistaken in reading Second Circuit precedent as conferring broad discretion on district courts to fashion appropriate sanctions, including imposing adverse inferences. Nevertheless, the substance of the district court’s adverse inference dealt with a key component of inequitable conduct—intent to deceive the USPTO—unquestionably a matter of substantive patent law on which Federal Circuit law controls. Although not without its critics, the Circuit’s 2011 en banc decision in Therasense is, for better or worse, the current defining framework for establishing inequitable conduct. Therasense tightened the standards for rendering patents unenforceable in an attempt to stem a perceived “plague” of inequitable conduct accusations. The en banc court required that the deceptive intent prong of inequitable conduct be independently proved based on clear and convincing evidence. By relying on Second Circuit law dealing with litigation sanctions and adverse inferences generally, the Regeneron II majority allowed satisfaction of Therasense’s substantial evidentiary burden of proof by a court imposing an adverse inference as a sanction for litigation misconduct, without conducting any evidentiary hearing or trial, on the fact question of intent to deceive the USPTO.

Determinants of successful patent applications to combat financial fraud

Finding out the characteristics of patent applications that lead to successful grants is an important and yet under-investigated topic in the scientometric literature. Using data from financial fraud-related patent applications submitted to the United States Patent and Trademark Office (USPTO), this study aims to determine which factors that can be influenced by inventors relate to successful patent grants. A descriptive statistical model is proposed to estimate the likelihood of a patent document being granted by the USPTO based on a number of explanatory variables. The following factors are among the notable statistically significant determinants for the studied patent sample: number of drawings, drafting aggressiveness, proportion of granted patent prior art references, proportion of web-based non-patent literature references, subclass specialization, and representation by a patent attorney or agent. The implications of these empirical findings are discussed in the context of entrepreneurship.

Evaluating the Duty of Disclosure in Patent Law

U.S. patent law imposes on applicants a duty to submit relevant prior art references to the USPTO, but the impact of this duty is unclear. On one hand, some studies suggest that applicant-submitted prior art references play an important role in influencing the scope of issued patents. On the other hand, some scholars have argued that examiners tend to ignore applicantsubmitted references in favor of their own search results. Moreover, the duty of disclosure forces applicants to bear both compliance costs and risks associated with undercompliance. In this paper I analyze a novel data set I constructed that describes the prosecution histories of more than 1.4 million issued U.S. patents. Applying this data set, I examine the extent to which the duty of disclosure yields references that patent examiners select to support rejections, which examiners use to weed out uninnovative patents and to force applicants to narrow overly broad patent claims. I also compare rejection references identified by applicants with those identified by examiners, and I identify characteristics of applicant-submitted references selected to support rejections. These findings have implications for several important legal and policy disputes, such as patent quality, proposed reforms to the duty of disclosure, and ongoing debates regarding the inequitable conduct doctrine.

The Federal Circuit's New Obviousness Jurisprudence: An Empirical Study

Following the Supreme Court’s 2007 decision in KSR v. Teleflex, commentators predicted that one of two things would happen: the Federal Circuit would change how it actually ruled on the issue of whether patents were obvious or that it would merely change what it said.This study empirically examines these two predictions using a novel dataset comprised of all pre- and post-KSR Federal Circuit decisions on obviousness over a fifteen-year period. Examining this data reveals strong evidence that KSR has indeed altered the outcomes of the Federal Circuit’s obviousness determinations, a change that has manifested in large part through an increase in the deference that the Federal Circuit is giving to district court determinations that patents are obvious. Moving beyond an examination of outcomes alone, this study uses the technique of content analysis to explore the heart of the second prediction: that KSR would affect what the Federal Circuit says about obviousness. This analysis demonstrates that the Federal Circuit has indeed changed what it says. Essentially gone is the use of the Federal Circuit’s ubiquitous pre-KSR “teaching, suggestion, or motivation” (“TSM”) framework in analyzing obviousness. Furthermore, while the underlying requirement that patent challengers identify some “reason to combine” or “reason to modify” prior art references has endured, it is hardly a reincarnation of TSM, either in terms of vigor or structure.

Priority and Novelty under the AIA

The Leahy-Smith America Invents Act of 2011, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”) radically transforms some of the most basic rules in the U.S. patent system. For many inventors and patent owners the most important changes center on priority and novelty. Practitioners working under the new rules will need to understand three basic issues to be most helpful to their clients. These are: (1) the critical date for most purposes is now the date that a patent application is first filed; (2) the prior art relevant to a given patent claim now consists of all references available under the statute prior to the filing date; and (3) priority contests between rival claimants to an invention will now be determined almost exclusively by looking to when each of the rivals filed their patent application. The discussion that follows elaborates a bit on these basic principles, and describes in general terms how they compare to the basic operating rules that pertain to the old, 1952 Act, system of priority and novelty.I begin with a brief explanation of the overall structure of the AIA’s novelty provisions. I then consider the related yet distinct concepts of novelty and priority, and explain how the AIA changes the basic parameters of both these fundamental issues. I pay particular attention to two new statutory issues -- the definition of “disclosure” and the creation of a “grace period” within which inventors can file a patent application. I explain a number of detailed aspects of the new rules, including: (1) why “disclosure” should be read as a general reference to all prior art references; (2) why this means that existing case law under the 1952 on public use and on sale activities continues in effect under the AIA (i.e., why the AIA does not overrule cases such as Metallizing Engineering); and (3) how to interpret the phrase “publicly disclosed” in the grace period part of the new statute, as distinct from “disclosure” generally. I conclude with some observations, sparked by the AIA, on continuity and change in the patent system.

Using social networking methods for analysis of patent prior art: the peer-to-patent experiment

The burgeoning backlog of patent applications at the US Patent and Trademark Office (USPTO) has created an urgent need for Office reform. Review of related application reference material, or prior art, is a necessary but time consuming step in the patent process. As a pilot project, the USPTO initiated the use of social networking software as a means to facilitate discussion amongst groups of volunteer review experts. The peer-to-patent pilot project allows experts outside the patent office to upload prior art references, participate in discussion forums, rate other user submissions and add research references to pending applications. This may help examiners to better focus their review on the submission of prior art that has the highest relevance to an application and thus streamline the overall application process.

Bilcare, KSR, Presumptions of Validity, Preliminary Relief, and Obviousness in Patent Law

In Bilcare Ltd. v. M/S The Supreme Industries Ltd., the Delhi High Court affirmed a lower court order vacating ex parte injunctions against an alleged infringer of a patent, rejecting arguments that the patent should be presumed valid even though the patent was the subject of opposition proceedings. In KSR International, Inc. v. Teleflex Co., the U.S. Supreme Court reversed the U.S. Court of Appeals for the Federal Circuit's long-standing interpretation of Section 103 of the Patent Act, i.e., that a challenger seeking to prove invalidity must demonstrate a teaching, suggestion, or motivation to combine prior art references. These cases reveal important insights (within varying procedural and substantive legal contexts) into statutory and judicial presumptions of validity that result from the grant of patents by administrative agencies. The article explains how such presumptions relate to evidence and proof rather than to the weight accorded to legal judgments. Using Bilcare as a reference, the article suggests that opportunities to present evidence challenging validity should be provided even in preliminary relief contexts, and discusses concerns that arise when validity is challenged in both administrative and judicial systems. The article then describes how the KSR decision adopted substantive legal rules for obviousness that supersede the statutory presumption of validity, shift the burdens of production and persuasion, and (for some inventions) limit the scope of relevant evidence that can be used by patent holders to prove non-obviousness. Finally, the article argues that the U.S. statutory presumption should not continue to be construed by the courts to impose heightened burdens of proving invalidity. (Forthcoming in Spanish as translated by Carlos Correa, Revista Juridica Argentina La Ley)

Lending a Hand: The Need for Public Participation in Patent Examination and Beyond

Under current patent practice, a single examiner, often overworked and with limited resources, must review an invention for patentability, investigate prior art references, and pass judgment on its novelty and nonobviousness in a very compressed timeframe. As a result of these pressures, bad patents are being issued with increasing frequency, especially in emerging technology fields such as software and biotech where the USPTO lacks a sufficient number of competent examiners for the workload. In particular, many of these examiners are simply unable to conduct a thorough prior art search within the timeframes given, and this problem is only exasperated with increased complexity of the inventions. In response to this problem, Beth Noveck has proposed the Community Patent Project, where third parties will be able to suggest prior art references, review those submitted by others, and ultimately produce a document that examiners can use to supplement their own prior art searches. Following a model popularized by open source programming and community-driven networks such as Wikipedia, this Project will help to assuage some of the pressures felt by the examiner, while improving the quality of the searches performed and, hopefully, produce more complete and valid patents. While this Project will be beneficial as a proof of concept, this Comment questions whether the Project will ever be viable on a larger scale. It then suggests that with a few tweaks, such as a more robust treatment of foreign languages and an improved incentive system, the Project could truly realize its goal of globalizing the patent examination process.

The Disputed Quality of Software Patents

We analyze the characteristics of the patents held by firms in the software industry. Unlike prior researchers, we rely on examination of the individual patents to determine which patents involve software inventions. This method of identifying the relevant patents is more laborious than the methods that previous scholars have used, but it produces a dataset from which we can learn more about the role of patents in the software industry. In general, we find that the patents computer technology firms obtain on software inventions have more prior art references, claims, and forward citations than the patents the same firms obtain on non-software inventions. We also find that the patents that software firms obtain on software inventions also have more prior art references, claims, and forward citations than the software patents obtained by the firms that derive revenues from other product lines. Finally, we conclude that the patents of the largest firms are no better (or worse) than the patents of the smallest firms, belying the idea that large firms are plagued by challenges based on the worthless patents of their smaller competitors. The paper closes with a brief discussion of the implications of our empirical analysis. The findings undermine the strongest criticisms about the low quality of software patents. It is simply not accurate to say that software patents as a class have remarkably low numbers of prior art references and forward citations. Thus, they cut against technology-based patent reforms designed to make it more difficult to obtain software patents. On the other hand, the evidence that small firms are no less capable than large firms at producing quality patents vitiates concerns that higher hurdles at the early stage of the patenting process would disadvantage smaller inventors in particular.

Patent Law Viewed Through an Evidentiary Lens: The 'Suggestion Test' as a Rule of Evidence

The Federal Circuit's recent nonobviousness jurisprudence has been the subject of much criticism. Reports from the Federal Trade Commission and the National Research Council and a pending petition for certiorari to the Supreme Court all conclude that the Federal Circuit has improperly relaxed the nonobviousness standard. Most of this criticism focuses on the Federal Circuit's implementation of part of the nonobviousness inquiry - the suggestion test. The suggestion test queries whether a suggestion to make the invention existed before the invention's creation. The Federal Circuit allegedly requires a suggestion to come solely from prior art references. The court ignores other evidence of undocumented suggestions that may exist in the knowledge of those skilled in the relevant technology or the nature of the problem being solved. This Article tests the validity of this criticism and finds that the Federal Circuit has not narrowed the suggestion test. By taking a novel look at the jurisprudence, the Article concludes that, instead, the court has adopted an evidentiary-like aspect to the suggestion test. Those cases where it appears the court is focusing only on the prior art are actually instances where the court is exercising an evidentiary aspect of the suggestion test. The suggestion test's rule of evidence excludes undocumented evidence of suggestion that does not contain the requisite detail and analysis. This rule of evidence is tailored to adjust the level of detail and analysis required to correspond to the complexity of the technology at issue. As a result, the suggestion test's rule of evidence helps to reduce overvaluation of suggestion evidence and the resulting, incorrect obviousness determinations. However, the rule may produce some erroneous nonobviousness determinations of its own, particularly at the United States Patent and Trademark Office, and thus should be relaxed in this context. Finally, this use of an evidentiary lens to look at, and evaluate, patent doctrine has application in patent law far beyond nonobviousness and the suggestion test.

On the Feasibility of Improving Patent Quality One Technology at a Time: The Case of Business Methods

Following the Federal Circuit's 1998 decision in State Street Bank & Trust Co. v. Signature Financial Group, Inc. holding that there was no per se exclusion from patentability for software-implemented business methods, the number of applications for and grants of such patents on increased dramatically. A large number of critics castigated them for two primary reasons: First, some contended that patents should simply not be allowed on such subject matter. Second, a much larger number of critics asserted that these patents were of singularly inferior quality because they had been issued without due consideration to the relevant prior art-documentary evidence of what others had done in the past. In response to these criticisms, the United States Patent and Trademark Office (PTO) instituted an initiative in March 2000 that it called the Second Pair of Eyes Review, intended to make it more difficult to obtain business method patents. Among other features, the SPER program called for a second-level review upon allowance for patent applications in Main Class 705. Each of the authors had independently conducted previous research leading us to conclude that software-implemented business method patents cited prior art that was not inferior in quantity or quality to other types of patents, and that the many prior art-related criticisms were not supported by empirical evidence. Although some business method patents undoubtedly were of low quality, one finds low-quality patents in all fields. Be that as it may, we believe it important to empirically assess the effects of the SPER initiative. The program requires substantial resources, and if it has not had significant positive effects, these wasted resources constitute a tax on innovation because the PTO is supported by user fees. Perhaps a more important reason for evaluating SPER's effects, however, is that the PTO declared it to be a success and announced plans to expand it to other fields. Whether or not the agency expands the program in the near term, it is important to know whether targeting patent reforms at particular technology fields is a model that should ever be replicated. Employing negative binomial regression models, we found that the SPER initiative did indeed have significant positive effects on the quantity and quality of prior art cited in patent applications to which it applied. Using logistic regression, we determined that the SPER initiative also led to a significant increase in the number of Main Class 705 patents that cited at least some prior art. Moreover, we found that, after SPER, examiners themselves added significantly more prior art references that did examiners of closely related patents with Secondary 705 classifications. Success within this narrow operative domain, however, is seriously tempered by a number of factors, leading to the conclusion that attempting to improve patent quality one technology at a time is not a model that should be repeated. Because of definitional problems that are impossible to overcome, and because the patent classification system is very poorly suited for this kind of task, such an approach to patent reform is and always will be grossly underinclusive and subject to gaming by both patent applicants and beleaguered patent examiners. Attempts to improve patent quality should not focus on a single field.

On the Feasibility of Improving Patent Quality One Technology at a Time: The Case of Business Methods

Following the Federal Circuit's 1998 decision in State Street Bank & Trust Co. v. Signature Financial Group, Inc. holding that there was no per se exclusion from patentability for software-implemented business methods, the number of applications for and grants of such patents on increased dramatically. A large number of critics castigated them for two primary reasons: First, some contended that patents should simply not be allowed on such subject matter. Second, a much larger number of critics asserted that these patents were of singularly inferior quality because they had been issued without due consideration to the relevant prior art-documentary evidence of what others had done in the past. In response to these criticisms, the United States Patent and Trademark Office (PTO) instituted an initiative in March 2000 that it called the Second Pair of Eyes Review, intended to make it more difficult to obtain business method patents. Among other features, the SPER program called for a second-level review upon allowance for patent applications in Main Class 705. Each of the authors had independently conducted previous research leading us to conclude that software-implemented business method patents cited prior art that was not inferior in quantity or quality to other types of patents, and that the many prior art-related criticisms were not supported by empirical evidence. Although some business method patents undoubtedly were of low quality, one finds low-quality patents in all fields. Be that as it may, we believe it important to empirically assess the effects of the SPER initiative. The program requires substantial resources, and if it has not had significant positive effects, these wasted resources constitute a tax on innovation because the PTO is supported by user fees. Perhaps a more important reason for evaluating SPER's effects, however, is that the PTO declared it to be a success and announced plans to expand it to other fields. Whether or not the agency expands the program in the near term, it is important to know whether targeting patent reforms at particular technology fields is a model that should ever be replicated. Employing negative binomial regression models, we found that the SPER initiative did indeed have significant positive effects on the quantity and quality of prior art cited in patent applications to which it applied. Using logistic regression, we determined that the SPER initiative also led to a significant increase in the number of Main Class 705 patents that cited at least some prior art. Moreover, we found that, after SPER, examiners themselves added significantly more prior art references that did examiners of closely related patents with Secondary 705 classifications. Success within this narrow operative domain, however, is seriously tempered by a number of factors, leading to the conclusion that attempting to improve patent quality one technology at a time is not a model that should be repeated. Because of definitional problems that are impossible to overcome, and because the patent classification system is very poorly suited for this kind of task, such an approach to patent reform is and always will be grossly underinclusive and subject to gaming by both patent applicants and beleaguered patent examiners. Attempts to improve patent quality should not focus on a single field.

The Growing Complexity of the United States Patent System

In this Article, we compare a data set of 1000 U.S. patents issued between 1996 and 1998 to a similarly random sample of 1000 patents issued twenty years earlier, between 1976 and 1978. By studying the differences between the groups, we can get a clear picture of how the patent system has changed over time. The results are dramatic. By almost any measure - subject matter, time spent in prosecution, number of prior art references cited, number of claims, number of continuation applications filed, number of inventors - the patents issued in the late 1990s are more complex than those issued in the 1970s. While some of these effects are attributable to the patenting of new technologies like biotechnology and software, unknown in the early 1970s, the increase in complexity is robust even across areas of technology. Further, the patent system in the 1990s is more heterogeneous than it was in the 1970s. There are far greater differences by area of technology and by nationality in how patents are being prosecuted in the 1990s than there were in the 1970s. We explore a number of possible explanations for these results, and discuss the policy implications of the lack of uniformity that now characterizes our patent system.

Who's Patenting What? An Empirical Exploration of Patent Prosecution

We have studied a large, random sample of U.S. patents issued between 1996 and 1998. We collected a variety of information about these patents, including area of technology, national origin, the number of inventors, nature and size of the owning entity, the number and type of prior art references, and the time spent in prosecution. We seek to establish relationships between a number of variables in issued patents-such as number of inventors, numbers and types of references to the prior art, numbers and types of claims, and length of time between application and issuance-and a number of defined areas of technology. We identify the countries in which particular inventions originated--almost one-half of all issued U.S. patents cover inventions originating in other countries--and test for relationships between the above variables and countries of origin. We also evaluate relationships between countries of origin and areas of technology. The conclusions are somewhat surprising, and point to a patent system that is far from unitary in the way it treats different inventors and different inventions.