Another Gaming Patent Struck Down as IneligibleBot M8 LLC, a patent assertion entity, was unsuccessful in its effort to have the Federal Circuit reverse the lower court’s invalidity finding related to one of six different patents asserted against Sony in Northern District of California. In fact, the Federal Circuit was so unpersuaded by Bot M8’s arguments that it devoted less than a page of the 25-page opinion to this portion of the appeal. That being said, the little that was written is yet another reminder to draft and prosecute software/gaming patent applications with patent eligibility attacks in mind.

Since the court found “no need to discuss [the district court’s § 101] analysis in any detail,” and instead found claim 1 of U.S. Patent No. 7,338,363 (“the ’363 patent”) ineligible under § 101 for the reasons explained by the district court, we need to take a look at the lower court’s analysis of the purported improved gaming machine to gain insight. A quick background recap: Sony moved for summary judgment of invalidity of claim 1 of the ʼ363 patent under 35 U.S.C. § 101 after the infringement claims in the other four asserted patents were dismissed for failure to state a claim. Sony’s main argument was that claim 1 of the ’363 patent was directed to the abstract idea of “adding numbers (i.e., ‘game results’) in order to generate further numbers (i.e., ‘total result’ and ‘specification value’).”

The lower court found that the ʼ363 patent met step 1 of Alice in that it was directed to the abstract idea and failed step 2 of Alice since the court found no inventive concept. At step 1, the abstract idea was deemed to be “increasing or decreasing the risk-to-reward ratio, or more broadly the difficulty, of a multi-player game based upon previous aggregate results.” The lower court opined that “[a]t the most specific, claim 1 of the ’363 patent doesn’t actually teach how to increase or decrease the difficulty of a slot machine, or any gaming machine for that matter, based on prior results to keep players engaged.” Instead, “a game machine that updates the game conditions based on past results to keep players engaged” is merely a result, not the necessary means or process to achieve that result.

Looking at the claim itself (reproduced below for ease of reference), it might seem that, because it expressly features a gaming machine, it is a sufficiently tangible invention.

1. A first gaming machine for transmitting/receiving data to/from a server, comprising:

a specification value setting device for setting at least one specification value as a control condition for game control;

a transmitting device for transmitting data of a game result to the server;

a gaming machine determining device for determining a second gaming machine operated by a co-player;

a total result data receiving device for receiving from the server data of a total game result achieved by the first gaming machine and the second gaming machine based on the data of the game result transmitted by the transmitting device;

a specification value determining device for determining a specification value based on the data of the total game result received by the total result data receiving device; and

a specification value renewing device for renewing to replace the specification value set by the specification value setting device with the specification value determined by the specification value determining device.

However, step 1 of Alice looks to the focus of the claim and its character as a whole to determine whether a claim recites an abstract idea. Here, the tangible component (i.e., the gaming machine) merely limits the abstract idea to a particular environment. In other words, the focus of the claim was not the machine, but instead the abstract idea of increasing or decreasing the odds or difficulty of a gaming machine based upon the players’ winnings or losses. And, there is nothing in the claim that recites how the conditions of the game change based on the game results.

Moving on to step 2, the court deemed the claim elements to merely describe “generic and functional hardware” to accomplish the abstract duties. More specifically, transmitting data, determining a specification value, and replacing a specification value were considered conventional computer tasks. The court also noted that, while sometimes the order of claim elements can transform an invention into patentable subject matter, there was nothing in the order of the elements in claim 1 of the ʼ363 patent that saved it from the ineligible fate. In short, the court found that “neither the patent specification, patent owner, or patent owner’s experts articulate a technological problem solved by the ’363 patent.”

How could this claim have been written differently to be patent eligible? Perhaps the claim might have included more detail on how the game specification value increases if the players perform well and how the game specification value decreases if the players perform poorly. But, keep in mind, the specification needs to be written in a way that supports the claim language. Here, the written description was also found lacking since it only “partially illuminates the parameters to change, the payout parameters, and the driving variable, the actual prior payout.” The lower court found that the descriptions were vague and qualitative and failed to provide any teaching of threshold values that trigger changed game parameters. And, let’s face it, predicting patent ineligibility attacks is difficult, especially since different jurisdictions (and even judges within the same jurisdictions) interpret § 101 differently. This highlights why careful and creative drafting from the onset and diligence during prosecution are so critical in patent applications related to software and gaming.

On a closing note, even though Bot M8 lost this battle, its war against Sony is not over. In fact, the infringement claims of two other asserted patents were revived by the Federal Circuit in this same opinion. To read more about the Federal Circuit’s view of the lower court’s demands on Bot M8 for sufficiently pleading its infringement allegations, click here.

Court Decision Means that Antibody Patenting Is Not Getting EasierPatenting antibodies has long been challenging. Although most inventions can be patented based on their functionality, assuming the functionality is new and non-obvious, for antibodies and other biomolecules there is a higher standard. Although the antibody standard was recently challenged, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided to uphold it.

The Historic Antibody Rule

One of the main requirements for a patent is that the invention be described thoroughly enough to enable the reader to make and use the invention, given that the reader is skilled in the relevant field, and given that a certain level of experimentation is expected. Section 112(a) of the Patent Act states (in part) that “The specification shall contain a written description of the invention, and of the manner and process of making and using it… as to enable any person skilled in the art… to make and use the same.” The main function of antibodies is to recognize specific antigens through targeted binding. Thus, when new antibodies are invented or discovered, their valuable function is their ability to specifically bind antigens. In the early days of antibody technology, antibodies were claimed according to this function, by claiming for example “An antibody that binds to antigen X.”

The Modern Antibody Rule

In a landmark case of AbbVie Deutschland GmbH & Co. v. Janssen Bio-tech, Inc., the CAFC decided that claiming an antibody as defined by its antigen was too permissive. It reasoned that it is too difficult to predict whether a given antibody will bind a given antigen, and it would require excessive testing (“undue experimentation”) to screen all possible antibodies for this function. At that time, the field had very little understanding of how the structure of an antibody correlates to its binding target and specificity. Typically monoclonal antibody lines were screened and selected based on binding characteristics, rather than being designed or engineered. Often the structure of the antibody was analyzed after screening. An antibody could be claimed in a patent based on its structure (including its 3D structure or amino acid sequence) and based on its parental monoclonal cell line, but not based on its binding target. Similar logic was used to prevent the patenting of other biomolecules with specific binding characteristics. However, in its In re Wands opinion, the CAFC upheld a patent for “monoclonal high affinity IgM antibodies immunoreactive with HBsAg determinants” due to the specific source and structure included in the claim. Another exception to this rule is when the invention is a nucleic acid (e.g., DNA or RNA); because the mechanism of nucleic acid binding to other nucleic acids is well understood, an inventor is allowed to define a nucleic acid invention based on its binding partner.

The Recent Challenge in Amgen

The antibody rule was recently challenged in Amgen Inc. v. Sanofi, Aventisub LLC. The inventors in that case developed numerous lines of monoclonal antibodies capable of binding to the proprotein convertase subtilisin/kexin type 9 (“PCSK9”) enzyme. PCSK9 plays a role in cholesterol metabolism, and the inventors discovered that certain antibodies that bind at specific locations on the enzyme potentially reduce circulating low density lipoprotein (LDL – sometimes referred to as “bad cholesterol”). Numerous examples of such antibodies were described in the patents. Each of the patents claimed the antibodies based on the ability to bind to specific parts of PCSK9. The patents did not claim the antibodies based on anything about the antibodies’ structures, such as amino acid sequences or 3D structures. When challenged, the inventors argued that the many examples of the inventive antibodies in the patents gave enough information to the reader to make and use the invention, which is all that is required by the law. The inventors also argued that the challenger was unable to identify any particular claimed antibody that a skilled person could not make and use without undue experimentation. On the other hand, the challenger argued that the patent potentially covered millions of individual antibodies, and it was beyond the capabilities of even a skilled person to make and use every single one.

The trial court held that even with many working examples of antibodies capable of binding as claimed, one skilled in the art would not be able to make and use the broad class (or “genus”) of antibodies capable of such binding. On appeal a three judge panel of the CAFC agreed. The panel agreed with the challenger that “it is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim.” The court cited past cases in which the claims were limited to biomolecules having certain structures, and so “the full scope of the claim[s]” was also limited; in those cases the courts usually found the claims met the enablement requirement. However, in cases such as the one at bar, where there were no structural limits on the antibodies, the genus of antibodies claimed is too vast to be enabled based only on a few dozen examples.

Amgen requested that the CAFC reconsider the decision by convening every judge on the circuit en banc. When the CAFC decides matters en banc it creates a precedent that must be followed. However, the request was refused. Three of the judges issued an accompanying opinion as to why en banc review was unnecessary was issued, reinforcing the logic of the original decision and mocking those who disagree (“It seems to them that the sky is falling”). The accompanying opinion emphasized that the standard applied in Amgen is an application of prior precedent, and merely maintains the status quo ante. It pointed out that patents for non-biological chemicals typically contain numerous examples of versions of the chemical, including structures and instructions for synthesis. The relevance of this fact is not clear, as Amgen’s patent also contained numerous examples of its antibodies. The opinion also characterized functional claims as “the problem,” although functional claims are the only type of patent claim affirmatively authorized in the Patent Act (in Section 112(f)).

The Lessons for Antibody Inventions

Despite consistent precedent from the courts and the U.S. Patent and Trademark Office on this point, many patent applicants attempt to patent antibodies based on their binding characteristics, either in defiance of the AbbVie rule, or in ignorance of it.

The bottom line is that claiming antibodies and other biomolecules based on binding characteristics is going to remain difficult, especially when there is no understanding of how the molecule’s structure contributes to binding the target. When patenting biomolecules that are useful due to their binding characteristics, make sure to prepare robust claims that do not solely depend in identifying the binding target. The Amgen case is instructive, because the inventor claimed the antibody not only by its target molecule, but more specifically by the portion of the molecule that is targeted. This was not availing, however. The court did not distinguish between a claim to a targeted molecule or a targeted portion of a molecule. Patent applicants should take note, and avoid relying solely on the specificity of the target to support the patentability of the antibody.

Robust claims protecting antibody-based inventions can be drafted for the applications of the antibody. Such applications commonly include methods of diagnosis, Western blotting, non-diagnostic immunoassays, methods of medical treatment, personalized medicine (i.e., methods of diagnosis coupled to methods of treatment), and prophylaxis (e.g., prevention of prenatal hemolytic disease). For example, while a claim for “An antibody capable of binding enzyme X” is very difficult to patent, one can patent “A method of detecting enzyme X comprising binding enzyme X to an antibody.” Specific antibodies can be patented by patenting the hybridoma lines used to produce them, as well. An antibody can be patented by claiming its specific structure, independent of its functionality, although such claims are often too narrow to be very valuable.

Alternatively, antibodies can be protected by other forms of intellectual property. Many commercial antibodies are never patented; instead the hybridoma lines used to produce them are maintained as trade secrets, and the antibodies are either sold to others or used in-house. Selling antibodies usually will not compromise the confidentiality of the hybridoma line, because of the difficulty in reverse engineering the hybridoma line based on the antibody. Some business models involve the distribution of the hybridoma line under a material transfer agreement (MTA) or other form of nondisclosure agreement. This can be preferable to patenting for numerous reasons. No government approval is required, avoiding the need to meet the enablement requirement or the other requirements for novelty, non-obviousness, etc. Preparing and prosecuting a patent application incurs significant legal costs; although protecting trade secrets does also, the costs are typically much lower. Patents have finite lifespans, and require maintenance fees. Trade secrets have no set lifespan, and require no maintenance fees. The one weakness of trade secrecy protection is that it is not easily compatible with regulatory requirements for biologic medical treatments. These require large amounts of disclosure to the regulatory agency that could compromise the confidentiality of the hybridoma lines.

Although antibody technology is not new, it remains one of the most nuanced areas of technology for patenting. Intellectual property strategy for antibody technology should consider whether patenting is practical or desirable, and always look to the option of using trade secrecy instead. When patents are sought, never assume that a patent can be obtained based only on the antibody’s target, but rather formulate alternative strategies for effectively patenting the antibody (such as based on its structure) or its likely uses.

Stanford’s Method for Inferring Haplotype Phase is Not Patent EligibleStanford University applied for a U.S. patent for statistical methods of predicting haplotype phase. In 2019, the Patent Trial and Appeal Board rejected the application as ineligible subject matter. Last week, a panel of the U.S. Court of Appeals for the Federal Circuit affirmed.

The opinion is interesting for being related to two, often separate fields: software and medicine (specifically genetics and bioinformatics). So, let’s look at what the Federal Circuit said about this computerized method for haplotype estimation.

Haplotype estimation

Gene sequencing is common for determining the genes present in an individual. But standard sequencing techniques cannot always resolve which parent a group of alleles came from — known as haplotype phasing. Stanford’s application describes statistical methods for resolving the haplotype phases for a group of unrelated individuals.

The key statistical model in this technique is a hidden Markov model (HMM). In an HMM, you assume that an observable process is being influenced by something unobservable — “hidden states.” Then, by studying the process, you can learn about the hidden state. In the present case, the observable genotype is assumed to be influenced by the unobservable haplotype. By studying the genotypes of many unrelated individuals, the HMM allows estimation of the individuals’ haplotypes.

The ’982 Application

In U.S. Patent Application No. 13/486,982, Stanford describes a computerized method of estimating (inferring) haplotype phase in a collection of unrelated individuals. The ’982 Application includes two independent claims, of which Claim 1 is representative.

  1. A computerized method for inferring haplotype phase in a collection of unrelated individuals, comprising:

receiving genotype data describing human genotypes for a plurality of individuals and storing the genotype data on a memory of a computer system;

imputing an initial haplotype phase for each individual in the plurality of individuals based on a statistical model and storing the initial haplotype phase for each individual in the plurality of individuals on a computer system comprising a processor a memory [sic];

building a data structure describing a Hidden Markov Model, where the data structure contains:

a set of imputed haplotype phases comprising the imputed initial haplotype phases for each individual in the plurality of individuals;

a set of parameters comprising local recombination rates and mutation rates;

wherein any change to the set of imputed haplotype phases contained within the data structure automatically results in re-computation of the set of parameters comprising local recombination rates and mutation rates contained within the data structure;

repeatedly randomly modifying at least one of the imputed initial haplotype phases in the set of imputed haplotype phases to automatically re-compute a new set of parameters comprising local recombination rates and mutation rates that are stored within the data structure;

automatically replacing an imputed haplotype phase for an individual with a randomly modified haplotype phase within the data structure, when the new set of parameters indicate that the randomly modified haplotype phase is more likely than an existing imputed haplotype phase;

extracting at least one final predicted haplotype phase from the data structure as a phased haplotype for an individual; and

storing the at least one final predicted haplotype phase for the individual on a memory of a computer system.

The novelty of the ’982 Application is in the specific HMM employed. By using imputed haplotypes as the hidden states, Stanford’s method improves the accuracy of haplotype predictions. Importantly, while the claim does attempt to recite hardware limitations, the CAFC noted that “it is hard to imagine a patent claim that recites hardware limitation in more generic terms” than does Claim 1.

Stanford’s computational method of genome analysis fails the Alice test

In applying the first step of the test set forth by the Supreme Court in Alice, the CAFC agreed with the board in that the ’982 Application is directed to “mathematical calculations and statistical modeling.” This is not surprising given the nature of the claims, which even recite specific mathematical formulas. Nor did the recited steps of “receiving, … imputing, … extracting, … and storing” data convert the math into a practical application. According to the Federal Circuit, those steps are too generic and could be implemented with a regular computer.

The CAFC also agreed with the board in that the claims of the ’982 Application do not improve a technological process. In its brief and during oral argument, Stanford leaned heavily on Enfish, arguing that its claims represent an improvement to a technological process in bioinformatics. It based that claim on improvements in accuracy and efficiency of its method over the prior art. The U.S. government argued that any improvement was only to the math itself — an improvement to abstract math is still only abstract math. The court agreed that “[t]he different use of a mathematical calculation, even one that yields different or better results, does not render patent eligible subject matter.”

Finally, as noted above, the court found no inventive concept that could rescue the claims. The steps of manipulating data could be performed on a generic computer. Even considered as an ordered combination, the claimed method is only a “basic tool[] of scientific … work.”

Practice points

First, preserve all arguments so that you can avoid waiver on appeal. At the board, Stanford failed to raise increased efficiency as a technical improvement of its method. When Stanford attempted to argue this point at the CAFC, the court refused to address it since the argument had been waived.

Second, as the U.S. Government said during oral arguments, “narrow math is still math.” No matter how specific the method, it must be more than an abstract idea. The degree of preemption by the ’982 Application would have been narrow to none. But while preemption is a mark of ineligibility, “the absence of complete preemption does not demonstrate patent eligibility.”

Finally — given the complexity and ever-changing nature of the law of subject-matter eligibility under § 101 — involve experienced counsel early. Problems with the initial application can be difficult to correct later, so it is beneficial to frame the application correctly in the first instance. Bradley’s attorneys have significant experience with subject matter eligibility and would be glad to assist with the prosecution of software- and data-related inventions.