Patenting COVID-19 Tests: Avoiding the Common PitfallsThe impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available.  However, many of the tests have proven inaccurate, and it is becoming clear that more needs to be invested in validation before tests can be rolled out to the public. It is also becoming clear that this pandemic will persist for months or possibly years — it may even recur periodically like many other communicable diseases. This has created incentives for the development of validated tests for use not only in the immediate future, but possibly for years to come.

The cost of developing and validating diagnostic tests can be efficiently recouped if the test is patented, giving the developer an exclusive market for a finite period. However, one hoping to patent a COVID-19 test must plan to avoid certain foreseeable difficulties inherent in American law in doing so.

Obviousness in the Post-Genomics Age

Under Section 103 of the Patent Act, a patent cannot be obtained if “the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” Novelty by itself is not sufficient for patenting. Even an invention that has never existed before can be denied a patent if a judge or a patent examiner deems it to be “obvious.” The American obviousness standard is a vague and subjective standard compared to foreign analogs. This virtually always presents an obstacle to patenting in the United States, and it is a particular concern when it comes to diagnosing COVID-19.

The genome of SARS-CoV-2 has been elucidated and is publicly known, and a great deal has been learned and published about the structural proteins in the virus. Any test that functions just by detecting a sequence in the genome is likely to be considered obvious. The rationale is that a person of ordinary skill would look to sequences in the virus’ genome, determine which are unique to the virus (or at least absent from the human host), and try such sequences as a diagnostic target. The same holds true for structural proteins: If they are known to be part of the virus, it would be obvious to test for them to detect infection in the host. Stated another way, if the analyte is known but has never been used as a diagnostic indicator, it is presumed to be obvious to do so.

However, if it can be shown that testing for a certain target has unexpected advantages compared to other targets, then the test is not obvious. Examples of such advantages can include higher accuracy, higher specificity, less stringent purification steps, etc. In order to obtain a patent, one should be prepared to present evidence of such unexpected advantages, ideally in the patent application itself.

There can be non-obvious aspects of a diagnostic test apart from the analyte. For example, if the invention is a new assay to detect the analyte, or a new instrument to measure the analyte, it does not matter as much that the analyte itself might already be known. However, if the invention is a traditional type of test used on a known analyte (even if for the first time), be prepared to rebut an obviousness challenge.

The Mayo Ban on Patenting Diagnostic Tests

The United States also stands with a small number of countries that consider diagnostic tests as forbidden subject matter for patenting, regardless of how novel or non-obvious. The doctrine (“the Mayo ban”) has been reviewed in numerous earlier blog posts. The Supreme Court has taken the position that any actions that directly result in making a medical diagnosis cannot be patented as a method, because they are nothing more than “laws of nature.” In this case the “law of nature” is that the presence of an analyte is indicative to the presence of the disease. This includes physical steps such as obtaining samples and performing chemical and biochemical tests on the samples.

However, the courts have also opined that including a medical intervention in the method renders it more than just a law of nature. As a result, patents are allowed for combined methods of testing and treatment (or other forms of medical intervention). These usually take the form of a method that involves the act of testing followed by the act of treating if the test has a certain result.

In the context of COVID-19 this poses a specific difficulty: There is only one drug that is thought to be effective to treat the disease, and its effectiveness is still being validated to a great extent. This creates a problem if one tries to draft a patent claim that includes the act of treating COVID-19. A patent can only cover what a person of ordinary skill could successfully make and use based on the state of the art combined with the information in the patent application. It is not clear at present that the disease can be treated given the state of the art.

One possible solution to that dilemma is to claim an intervention that is not limited to treatment or does not include treatment. It could be mere supportive measures. It could be a contagion control measure, such as quarantine. Such measures go beyond simply diagnosing the patient.

Enablement: Are You Sure It Works?

As mentioned above, a requirement for patenting is that evidence must be provided that a person of ordinary skill could make and use the invention (i.e., it is “enabled”). The law allows such evidence to be provided as “paper chemistry” (modelling), in vitro data, animal data, and human trial data. However, the USPTO has a marked preference for animal and human data; they will sometimes accept in vitro results but will infrequently accept paper chemistry models when it comes to methods of medical diagnosis. This poses another problem. Presently there is no universally accepted animal model for COVID-19. A recent review concluded that several animals are permissive of the virus, but none appear to show the same severity of symptoms as humans; this calls into question the applicability of the models to human vaccines and treatments. Of course, human subjects provide the strongest data, but human testing is expensive and time consuming; human data are rarely available at the time a patent application is filed.

It is possible that the USPTO will view in vitro data permissively in light of these acknowledged issues at the present time. However, an accused infringer in court will not, and will take advantage of current limitations in validating COVID-19 tests in animals and humans to argue that patents are invalid because they are not enabled.

Summing Up: Prepare Your Patents Carefully

Under the best of conditions patent procurement can be a long and expensive process. Given the immediate demand for accurate and inexpensive COVID-19 tests and the complicating factors discussed above, patenting COVID-19 tests could be especially challenging unless preparations are made to avoid such challenges. Consideration should be given during the drafting process for ways to avoid rejections for obviousness, banned subject matter, and enablement. A modest amount of effort in the beginning of the process could shorten the patenting process by years and reduce patenting costs by thousands of dollars.

“Abstract Assertion of Breadth” Does Not Prove Non-EnablementMcRO, Inc., owns a U.S. patent on a method for animating faces in video games. Back in 2016, when McRO sued a number of video-game developers for patent infringement, the U.S. Court of Appeals for the Federal Circuit (CAFC) upheld the patent as subject-matter eligible. Now, the CAFC has again upheld the patent, this time against a challenge of non-enablement.

Patents must enable the full scope of claims

At their core, patents are a quid pro quo bargain. In return for patent rights, the inventor must teach the public how to practice the invention. The standard is: “After reading this disclosure, would a person skilled in the art know — without undue experimentation — how to practice the invention?” This is stated in Section 112 as the enablement requirement. If the written disclosure does not fully enable the claimed invention, then the inventor has not held up their end of the bargain and the patent is invalid. One ready way of attacking a patent as non-enabling is to point to an embodiment of the claimed invention that would not be understood from the disclosure. For example, if a patent claims pens of all colors, but only teaches how to make blue pens, then the patent is non-enabling and therefore invalid.

To show non-enablement, the defendants pointed to two methods of animation that were not fully enabled by the patent’s specification. But when the court found that neither method was infringing — and thus that both methods were outside the scope of the claims — the defendants offered no other concrete examples. They were left with an “abstract assertion” that the claims covered non-enabled methods. The CAFC held that an “abstract assertion of breadth” will not support a claim of non-enablement.

Animating speech in video games

When video-game characters speak, they sometimes look like sock puppets — the mouth opens and closes, the head might turn or nod. To realistically animate speech, designers must match the mouth shape to the character’s words and the facial expression to their emotions. Manually drawing that, frame by frame, takes too long. McRO’s patent covers a method for automatically generating the lip movements and facial expressions of speaking characters.

The method works by first associating each possible single sound (a phoneme) with one mouth position (a morph target). The patent describes specifying the mouth model by identifying vertices in particular positions. Then each morph target is defined as the set of vectors which describe the displacement of each vertex from its position on a neutral, reference mouth. Each facial expression is described by a blending of multiple morph targets in specific proportions, known as a “morph weight set.” This much of the method was known in the prior art.

The novelty of McRO’s patent is in automatically generating a stream of morph weight sets from a time-marked transcript of recorded phonemes. Before, artists would have had to assign the morph weight sets at each frame. But McRO’s patent describes using a set of rules to automatically generate the stream of morph weight sets, given only a time-aligned phonetic transcription.

The ’278 Patent

At issue were three method claims of U.S. Patent No. 6,611,278, of which claim 1 is representative:

  1. A method for automatically animating lip synchronization and facial expression of three-dimensional characters comprising:

obtaining a first set of rules that defines a morph weight set stream as a function of phoneme sequence and times associated with said phoneme sequence;

obtaining a plurality of sub-sequences of times phonemes corresponding to a desired audio sequence for said three-dimensional characters;

generating an output morph weight set stream by applying said first set of rules to each sub-sequence of said plurality of sub-sequences of timed phonemes; and

applying said output morph weight set stream to an input sequence of animated characters to generate an output sequence of animated characters with lip and facial expression synchronized to said audio sequence.

Under the CAFC’s construction in 2016, in the field of rules-based animation, the claims of the ’278 Patent are limited by defining morph weight sets as a function of the timing of phoneme subsequences. In the specification, morph weight set is defined in terms of a “delta set,” i.e., the set of displacement “vectors” of each vertex from the reference mouth. Critically, the CAFC agreed with the district court that these vectors must be three-dimensional.

Bones and BALDI

The defendant developers use “bones animation” to animate faces. As in the ’278 Patent, in bones animation, models are specified by identifying vertices and transformations of their positions. But in bones animation, the transformations are encoded as a four-by-four matrix defining movements which can include not only translations, but also rotations and scales. This is in contrast to the three-dimensional displacement vectors to which the ’278 Patent was limited by the court. Consequently, the district court had held that developers’ use of bones animation did not infringe McRO’s patent.

A second animation method the court calls “the BALDI system.” According to the district court, the BALDI system uses an interlocking set of mathematical equations that balance the influence of different proximate phonemes on various aspects of the model’s facial expression. As with bones animation, BALDI’s equations do not represent displacements of vertices by simple three-dimensional vectors.

Both bones and BALDI animation, then, do not infringe the claims of the ’278 Patent. The district court so held, and the CAFC agreed.

Abstract assertion of breadth

In addition to its finding of non-infringement, the district court had also invalidated the ’278 Patent for non-enablement. Section 112 requires that a patent enable a person skilled in the art to practice the full scope of the claimed invention. Importantly, a patent need only enable the claimed invention, not matter outside the claims. So the question of enablement depends on an interpretation of the claims — what they cover and what they don’t.

Following this logic, a finding of non-enablement requires “concrete identification of at least some embodiment or embodiments asserted not to be enabled.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The CAFC cited a number of cases to emphasize that the identification must be concrete, not abstract. To prove non-enablement, it is not enough to abstractly explain that that the claims might cover more than the disclosure enables. Instead, the courts will require a concrete example.

The developers pointed to two such concrete examples — bones animation and BALDI animation. They claimed that neither method was enabled by the specification. For example, each method uses transformations of more dimensions that the 3D vectors disclosed by the ’278 Patent. The developers attempted to show that the two methods were within the scope of the claims but were not enabled. As such, the ’278 Patent would not have enabled the full scope of the claimed invention and would therefore be invalid.

However, as discussed above, the developers had also argued that these methods were non-infringing — and the court agreed! The court interpreted the claims as reading on vectors only of three dimensions, leaving bones and BALDI outside the claims’ scope. This also removed them from the scope of methods which the ’278 Patent could be required to enable.

Without the bones and BALDI examples, the developers were left only with an “abstract assertion” that the claims exceeded the enabled scope. In particular, they focused on the “first set of rules” limitation in claim 1. This is conceivably broad, and the district court had found that it was broader than anything disclosed in the specification. The CAFC disagreed and narrowly construed the limitation according to the specification. It went even further and found that the “first set of rules” limitation would have been well known in the art, whether the ’278 Patent disclosed it or not. Finally, without any concrete example of a non-enabled embodiment, the developers’ “abstract assertion of [the] breadth” of the claims could not carry their burden under the Wands.

Practice points

This case is a good example of the interplay between enablement and claim interpretation. To win on non-infringement, the developers had argued for a narrow reading of the claims. But the narrow claims were fully enabled. Had they lost on infringement, they might have won on enablement. An interesting tension in itself, patent litigators can learn an important lesson from this case. Like Hercules at the crossroads, choose carefully.

Be careful how you choose your arguments. Lawyers are accustomed to arguing in the alternative, offering a number of arguments — even taking inconsistent positions — in the hope that one will carry the day. But if you aren’t careful, a win could lead to a loss. Certainly, the defendants were happy to get a judgment of non-infringement, so that they can keep doing what they do. But they likely would also have like a judgment of invalidity, so that they wouldn’t have to worry about the ’278 Patent in the future.

This might have been avoided with surgically precise claim constructions. The developers did not actually practice the BALDI method, only the bones method. Had they been able to get a claim interpretation that read on BALDI but not bones, the developers could have used BALDI as a concrete example for meeting their burden under Wands. They’d have gotten two victories for the price of one.

An Early Out Under § 101 Based on Claimed Long-standing Commercial PracticesLate last week, the U.S. Court of Appeals for the Federal Circuit delivered the affirmation it ordered in Electronic Communication Technologies, LLC (ECT) v., LLC. In doing so, the court supplied accused infringers with a helpful example of what may be appropriate for early dismissal under 35 U.S.C. § 101. In addition, this opinion discusses the ineligibility of claims directed at long-standing commercial practices.

ECT brought suit in the Southern District of Florida alleging that ShoppersChoice’s order and shipping confirmation systems infringed claim 11 of U.S. Patent No. 9,373,261. At a high level, the technology in this case is centered around an automated notification system that provides advance notice to customers about the pickup or delivery of a good or service. More specifically, the single asserted claim reads as follows:

An automated notification system, comprising:

one or more transceivers designed to communicate data;

one or more memories;

one or more processors; and

computer program code stored in the one or more memories and executed by the one or more processors, the computer program code comprising:

code that enables a first party associated with a personal communication device (PCD) to input or select authentication information for use in connection with a subsequent notification communication session involving advance notice of a delivery or pickup of a good or service at a stop location by a mobile thing (MT);

code that causes storage of the authentication information;

code that monitors location or travel information in connection with the MT;

code that causes initiation of the notification communication session to the PCD with the one or more transceivers, in advance of arrival of the MT at the stop location, based at least in part upon the location or travel information associated with the MT;

code that, during the notification communication session, provides the authentication information to the PCD that indicates to the first party that the notification communication session was initiated by an authorized source; and

code that, during the notification communication session, enables the first party to select whether or not to engage in a communication session with a second party having access to particulars of the pickup or delivery.

ShoppersChoice moved for judgment on the pleadings of invalidity under 35 U.S.C. § 101. Without engaging in any claim construction, the district court granted the motion when it held that the single asserted claim is abstract. In fact, while the district court conceded that the claim did include certain features that “add a degree of particularity to the invention,” such as the use of authentication information and the option to communicate with the pickup or delivery representative, it found that the “concept embodied by the invention is only the abstract idea of notifying a party of the travel status of a good or service.”

On appeal, ECT argued that the enhanced security protocols of its delivery notification system rendered the claim eligible under 35 U.S.C. § 101. In an effort to answer the question posed in Step 1 of the Alice/Mayo framework – i.e., are the claims directed to a patent-ineligible concept such as an abstract idea, law of nature, or natural phenomenon – the court first noted that the asserted claim recites a list of equipment – i.e., “one or more transceivers designed to communicate data;” “one or more memories;” “one or more processors;” and computer program code. The code (1) enables a first party to input authentication information; (2) stores the authentication information; (3) monitors the location of a mobile thing; (4) sends notification to the first party in advance of arrival of the mobile thing; (5) sends the authentication information to the first party; and (6) enables the party to select whether or not to communicate with a second party about the status of the mobile thing. Then, the court determined that functions (3) and (4) merely feature a fundamental business practice of letting a customer know in advance of the readiness for pickup or delivery. In short, the court found that the idea of providing advance notification of the pickup or delivery of a mobile thing was a long-standing commercial practice and, as such, abstract. Moreover, the added “security” measures in the claim – i.e., functions (1)-(2) and (5)-(6) – were also deemed to be abstract and amounting “to nothing more than gathering, storing, and transmitting information.” Indeed, the court distinguished the security measures in claim 11 of the ʼ261 patent from the improvements in computer capabilities that were held in previous decisions to be non-abstract under Step 1 of the Alice/Mayo framework.

With a determination under Step 1 that claim 11 is abstract, the court engaged in Step 2 of the Alice/Mayo framework to determine whether the claim contains an “inventive concept” to transform the claimed abstract idea into patent-eligible subject matter. Finding that the features in claim 11 are merely well understood, routine, and require nothing unconventional to apply the abstract idea, the court concluded that the claim was not saved under Step 2. The Federal Circuit reminded ECT (and us) that patent eligibility has nothing to do with the number of words in the claims, but rather focuses on the content therein. Moreover, the court noted that enablement of a claim does not in any way ensure that the claim is subject matter eligible under § 101.

As to ECT’s more creative argument that its good faith request after receiving a Notice of Allowance that the USPTO confirm § 101 eligibility — coupled with the expedited allowance — weighs in favor of eligibility, the Federal Circuit was unimpressed. Unfortunately for ECT, a patentee’s diligence and/or good faith during prosecution does not protect a claim from an Article III patent eligibility review. ECT also failed to convince the appellate panel that the district court erred in finding the asserted claim ineligible without engaging in claim construction. Indeed, without an argument from ECT that any specific term required construction, the court had a hard time buying into ECT’s argument. In fact, as noted by the court, it is appropriate to determine patent ineligibility under § 101 at the pleadings stage where the patentee has provided no proposed construction of any terms or proposed expert testimony that would change the § 101 analysis.

It seems that ECT might have fared better (at least at this early stage) if it had at least attempted to advance a specific and detailed claim construction argument in its opposition to ShoppersChoice’s motion. In fact, a number of denials of § 101 motions to dismiss based on patent eligibility have been based on the determination that claim construction is necessary to resolve the § 101 challenge. Nevertheless, this opinion provides an example of a successful early challenge under § 101 by an accused infringer. Because claim construction and discovery are costly phases of patent litigation, this type of early case-dispositive motion may allow a defendant to exit the suit without a significant financial hit.

As an aside, ShoppersChoice also recently argued (via teleconference) to the appellate court that the district court abused its discretion by not classifying this case as exceptional under 35 U.S.C. § 285 and not awarding attorneys’ fees. ShoppersChoice had three main arguments: (1) ECT improperly attempted to enforce the ’261 patent, which belongs to a family in which three patents have previously been invalidated; (2) ECT could not describe any claimed inventive concept to the district court; and (3) ECT has a prolific history of bringing allegedly nuisance infringement claims against multiple defendants. ECT countered that ShoppersChoice relies on patents that were not in the suit and non-precedential cases (with respect to ECT’s prior litigations). We will have to wait and see what the Federal Circuit decides, but it is not likely that the appellate court will disturb the district court’s order.