Diagnostic and Personalized Medicine Claims — Strategies for Navigating the §101 Minefield

Diagnostic and Personalized Medicine Claims -- Strategies for Navigating the §101 MinefieldIn Cleveland Clinic Foundation v. True Health Diagnostic LLC, the Federal Circuit (CAFC) dealt another blow to the patent eligibility of diagnostic methods and the growing field of personalized medicine.

Cleveland Clinic obtained three patents (US Patent Nos. 7,223,552, 7,459,286 and 8,349,581) directed to the use of the activity and/or levels myeloperoxidase (MPO) or a MPO oxidation products (the foregoing referred to as simply MPO in this discussion) to characterize/assess/predict a risk of cardiovascular disease in a subject. At a high level, the claims required: 1) determining a level/activity of MPO in a subject; 2) comparing this value with a control value; 3) and determining risk of disease when the MPO level/activity is increased as compared to the control. The claims in the patents also describes various forms and features of cardiovascular disease, such as when a cardiovascular event might occur.

The CAFC used the Alice two-step framework and found the claims were directed to “multistep methods for observing the law of nature that MPO correlates to cardiovascular disease” under step one and no feature of the claims, either alone or in an ordered combination, was sufficient to transform the law of nature into a patent-eligible concept under step two (citing the use of prior art techniques to detect MPO and statistical methods to determine the level of MPO and the control value). There was nothing dramatically different in the court’s Alice analysis than in previous cases.

Is a Correlation a Law of Nature?

The courts have consistently refused to provide a concrete definition of what is a natural law or an abstract idea. The courts rely heavily on determinations in prior cases to guide the inquiry. It could be argued there is no “natural law” that a subject with a high level of MPO will have an increased risk of cardiovascular disease. In some cases the correlation will not prove true, but in some cases it will. In many subjects, a high level of MPO will be asymptomatic (perhaps due to other aspects of the subject’s physiology). Likewise, many subjects with low MPO levels will have cardiovascular disease due to factors unrelated to MPO levels (for example, poor lifestyle or genetic predisposition). Furthermore, the correlation was shown to vary in certain aspects depending on the population studied and the time frame with which a cardiovascular event might occur. Given these discrepancies, is a correlation that holds true for only a portion of a population or only under certain defined conditions properly defined as a natural law?

Characterizing the Improvement over the Prior Art

Let’s take a step back and look at the claims in the context of the prior art. The claimed methods allow an improvement in the technological field or medical care. The simple blood test allows for the identification of patients that may benefit from additional care without invasive testing at a low cost using a simple procedure. The CAFC recognized the difference in the claimed methods (one of which detected MPO in the blood but was not predictive of cardiovascular disease) and the benefits of the claimed methods. Viewed in this manner, the claims are similar to those in Diamond v. Diehr, where an abstract idea was held to be patent eligible when the abstract idea was used in a process designed to solve a technological problem in conventional industry practice.

The CAFC distinguished this case from Rapid Litigation Management, Ltd. v. CellzDirect, where claims directed to a method of cryopreserving cells were eligible under §101, as we discussed in a previous post. In CellzDirect, the basis for the claimed methods was the discovery of an inherent property of liver cells to undergo multiple freeze-thaw cycles while still maintaining viability. The methods claimed in CellzDirect, such as those here, did not invent new techniques for the cryopreservation process (prior art methods and reagents were used), but rather claimed additional steps in the cryopreservation process based on the discovered natural property of liver cells to provide a new and useful laboratory technique. The method claims in this case take the presumed natural law of MPO correlation to certain types of cardiovascular disease and add additional limitations (for example, time frames for the onset of disease) or steps (for example, comparison to a control value) to produce a new and useful laboratory technique.

One possible reason for the holding in the present case may be the lack of specific information on how an “elevated” MPO level is determined, how the control value is determined, or how much above the control value the MPO level in the subject needs to be in order to be at risk for the defined conditions. The provision of such a defined decision point would have allowed arguments that the claims were directed not to the presumed natural law, but to a specific value derived by the hand of man. As such, the claims would not “start and end with the naturally occurring phenomenon” as prohibited in Ariosa.

Such a decision point could be implemented using an algorithm or “rule set” that provides cut-off values and criteria for the evaluation of the subject’s risk based on MPO levels and possible other risk factors (the specification discusses several, such as troponin-T). Such a rule set could also specify comparisons among discrete populations. While the use of such rule sets obviously limits claim scope to some extent, defining the claimed relationships with greater specificity offers additional arguments in the eligibility battle. An additional benefit is this approach potentially allows the omission of an explicit comparison step (as any comparison is accomplished by the rule set).

The use of rule sets was favorably viewed by the CAFC in McRO v. Bandai, noted in a previous post, where the court allowed a rather generic rule set to provide for §101 eligibility in a method of computer animation. The CAFC noted that the rule set in McRO “transformed a traditionally subjective process performed by human artists into a mathematically automated process executed on computers.” Claims that define the MPO correlation to a baseline value in determining an outcome should be viewed as transforming the subjective process of diagnosis into a defined process carried out by the claimed methods. While McRO is directed to the computer arts, the mantra of the CAFC is that each technological field is treated the same in terms of patent eligibility analysis.

Conclusion

While the CAFC held the claims at issue here to be invalid under §101, I do not believe the door is shut for meaningful patent claims directed to diagnostic methods and their use in personalized medicine. While the prevailing judicial view may require the recitation of additional elements with more specificity, thoughtful drafting of the specification and claims provides an opportunity for claims of the type invalidated here to withstand the scrutiny of the §101 analysis.

Improved Computer Functionality Argument Fails 101 Eligibility Test in Evolutionary Intelligence

Data and cell phonesNot all abstract ideas fall under the scrutiny of 35 USC 101. Over the past year, the CAFC has chipped away at the granite façade that is 35 USC 101 issuing several opinions finding abstract ideas to be patent eligible under the Alice framework (Enfish, Bascom and MRCO). In such cases, the court has identified factors that distinguish patent eligible subject matter from an abstract idea. One such factor is a determination that the invention as claimed improves the functionality of a computer itself.

The CAFC has also discussed the preemption doctrine as it applies to Section 101, but this doctrine has not been routinely applied in a direct manner. Each of these issues were front and center in Evolutionary Intelligence, LLC. v. Sprint Nextel Corporation (WL 655442, Fed. Cir. 2017).

District Court Analysis

Evolutionary Intelligence, LLC (EI) owns U.S. Patents 7,010,536 and 7,702,682. The EI patents describe systems and methods that allow “computers to process data that are dynamically modified based upon external-to-the-device information, such as location and time.”

The EI patents (each under the same logic) were held invalid under 35 USC 101. As an initial matter, the district court framed the 101 inquiry with an emphasis on preemption, which may have shaped how the court viewed the application of the Alice framework. Under step 2A of the Alice inquiry, the court held that the claims were directed to “age-old forms of information processing,” such as those used in “libraries, businesses, and other human enterprises with folders, books, time-cards, ledgers, and so on” and as such were abstract ideas.

Under step 2B of the Alice inquiry, the court found each step of the method and the various components required to implement the method to be routine and conventional. EI conceded the point, but argued the claims, when viewed as an ordered combination, improved the function of a computer itself by overcoming limitations inherent in the static information model of computerized data processing by allowing “computers to process containerized data in a way that results in dynamic modifications in order to improve future processing efforts by computers” (citing DDR Holdings).

The court disagreed and held that the problem solved by the EI patents, failure to dynamically update data structures over time and by location, or based on search history, was not a problem unique to the computing or even a computing problem, but is simply “an information organization problem.” In essence, because the problem to be solved could be found in a non-computer field, the court dismissed the solution provided by the ordered combination of the claims. It could be argued that the same could be said of the solution reached in DDR Holdings and Enfish, where the problems addressed (customer retention and data organization, respectively) could also be said to be present in the prior art.

The district court stated that an inventive feature question (which read as being equivalent to improving the functionality of a computer) under Section 101 asks whether the patent adds something to the abstract idea that is “integral to the claimed invention.” In making this inquiry, the court noted it was important to “distinguish between claim elements that are integral to the claimed invention from those that are merely integral to the abstract idea embodied in the invention.” This approach arguably is in conflict with the Alice mandate to examine the claim elements alone and as an ordered combination.

The court concluded by stating “Regardless of whether the concept of ‘dynamically’ updating information containers and registers may have been novel and nonobvious at the time this patent was filed, the claims do nothing to ground this abstract idea in a specific way, other than to implement the idea on a computer.” It appears the district court found the claims to be invalid under Section 101 based at least in part on preemption grounds (i.e., the failure of the specification to specifically describe a particular embodiment of how the method was implemented).

Federal Circuit Analysis

In a brief opinion, the CAFC upheld the district court decision. The panel agreed with the district court on the abstract idea (citing Affinity Labs of Texas, Intellectual Ventures I, and Electric Power Group). Enfish was distinguished on the grounds that the main focus of the claims in that case was on an improvement to computer functionality itself, stating that the specific improvement in Enfish related to the way a computer database carried out the basic functions of data storage and retrieval “regardless of the subject matter or use to which that functionality might be put.”

Regarding the step 2B analysis, the CAFC seemed to echo the district court’s pre-emption fears, stating “Whether analyzed individually or as an ordered combination, the claims recite those conventional elements at too high a level of generality to constitute an inventive concept.” The panel distinguished Bascom Global based on a specific implementation of the internet filtering protocol. Interestingly, the claimed methods in Bascom also recited the method steps at a high level of generality as compared to prior cases, such as Enfish.

Conclusion

This case again points to the dangers in viewing the exception to Section 101 (in this case an abstract idea) and the technical issue to be solved at a high level divorced from the features claimed. When claims are analyzed in this way, it becomes very difficult to show the additional claim elements add significantly more to the judicial exception as required under the current analytical framework. Furthermore, this characterization allows the preemption doctrine to come into play as well.

In writing the specification, it is important to carefully describe the claimed methods and their relationship to the prior art in order to allow a fact-finder to properly place the claims in the correct context vis-à-vis the prior art and problem to be solved.

Can You Be Reasonably Certain a Water Balloon Is Substantially Filled? Indefiniteness in Tinnus v. Telebrands

Tinnus v. TelebrandsIn Tinnus Enterprises, LLV v. Telebrands Enterprises (Fed. Cir. 2016-1410), the CAFC considered whether a claim requiring that a container (think water balloon) be “substantially filled” was indefinite under 35 USC §112. Complicating the issue, in this case the district court and the Patent Trial and Appeal Board (PTAB) reached different conclusions regarding the claims at issue in Tinnus, with the district court finding the claims valid and the PTAB finding the claims invalid under 35 USC §112.

The technology at issue in this case is simply a device for filling a plurality of balloons with a liquid. In operation, an elastic connector provides a connecting force that connects each balloon to an individual tube in communication with a liquid source. When the balloon becomes filled to a certain level (referred to as “substantially filled”) and the device is shaken, the weight of the “substantially filled” balloon overcomes the connecting force, the balloon is detached and sealed by the elastic connector. Telebrands challenged the validity of the claims contending the term “substantially filled” rendered the claims indefinite.

PTAB Reasoning

The indefiniteness issue at the PTAB centered on the phrase “a connecting force that is not less than a weight of one of the containers when substantially filled with water” recited in claim 1. Telebrands argued that determining whether a container is filled or substantially filled “is a hopeless exercise contingent upon a user’s subjective desire.” Indeed the specification of the patent at issue equated the concept of “substantially filled” as being subjectively determined (for example, equating substantially filled with a “desired size”). Tinnius countered by arguing that in the context of the patent, the term “substantially filled” was clear based on the experience of the user and the structure of the claims. Tinnius also argued that the “substantially filled” limitation was analogous to the claim limitations in Orthokinetics (claim requiring a leg portion of the chair to be “so dimensioned as to be insertable through the space between the doorframe of an automobile and one of the seats thereof). Regarding the Orthokinetics argument, the PTAB held there was no reference to a well-defined reference as in Orthokinetics because the connecting force could be varied by the user (with the result that a water balloon filled to the same level might infringe the claim in one instance but not another based on the selection of the connecting force). The PTAB also gave little weight to Tinnius’ expert, in part due to the failure of the expert opinion to place limits on the term substantially (the expert opinion equated “substantially” to “approximately”).

The PTAB concluded that there was no objective standard given in the specification for measuring whether something was filled, stating “A person of ordinary skill in the art could not interpret the metes and bounds of the phrase so as to understand how to avoid infringement because neither claim 1 nor the specification provides any objective standard for measuring the scope of the term ‘filled.’”

Federal Circuit Reasoning

Like before the PTAB, the issue at the district court/CAFC was the meaning of the term “filled” and “substantially filled.” As an initial matter, the CAFC found that the specification did not equate “substantially filled” with a “desired size” (a factor relied on in the PTAB decision), instead holding that the structure of the claims provides for a determination of when a balloon is “substantially filled” (stating that “if the balloons detach after shaking, then they are substantially filled”). The CAFC also found it incredulous that a person of ordinary skill in the art could not read the specification and determine with reasonable certainty when a balloon was “substantially filed.” The CAFC found no clear error with the district court’s determination that the claims met the Nautilus standard.

Differing Standards

The district court and CAFC applied the now familiar standard for claim indefiniteness under Nautilus, which states a claim is invalid as indefinite if the claim “read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.”

The PTAB, however, applies the standard under In re Packard, which states a claim is indefinite “when it contains words or phrases whose meaning is unclear.” The PTAB does not interpret Nautilus “to mandate the Board’s approach to indefiniteness in patent examination or reexamination matters or in AIA proceedings, in which the claims are interpreted under the broadest reasonable interpretation standard, and an opportunity to amend the claims is afforded.” The PTAB also recognized that the analysis under Packard may make it easier for a claim to be invalidated under 35 USC §112 in front of the Board than in federal court.

Reasons for the different outcomes?

This decision makes it clear that the Federal Circuit does not feel the need to defer to the PTAB, particularly when different legal standards are at play. However, several other procedural factors could have led to differing conclusions as to the indefiniteness issue.

First, Telebrands did not object to the indefiniteness determination of the magistrate judge, which resulted in a more onerous plain error review of the decision on appeal. Second, Telebrands did not directly raise the same issues cited by the PTAB as a basis to deny the preliminary injunction. These factors may have contributed to the different outcomes. As a result, Telebrands was limited in the arguments it could make at the CAFC and how the previously decided issues were reviewed.

This case provides important factors to consider when considering claim indefiniteness. Clearly, the broadest reasonable interpretation standard makes it easier for a claim to be found indefinite.  Without the broadest reasonable interpretation standard, the CAFC found more meaning and clarity in the individual claim terms than the PTAB. In advancing such arguments, the choice of administrative appeal versus litigation must be carefully considered based on the facts of each case in order to bring the case in the venue that is most advantageous.

Eli Lilly v. Teva – Expert Testimony and the Indefiniteness Inquiry

Vitamin B12In the patent world, claim scope depends on the meaning given to the individual words in the claim. If the meaning of a word in the claim is not clear, the claim may be attacked as invalid under the indefiniteness standard. Is a claim indefinite if the claim contains a term that is used by the patentee to refer to a specific compound in one part of the specification and to a broader class of related compounds in another part of the specification? If the claim contains a term that is admitted to have different meanings depending on the context in which the term is used? According to a recent ruling by the Federal Circuit, the answer to both questions is no.

35 U.S.C. § 112, ¶ 2, requires that a patent specification “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” Under the Supreme Court’s Nautilus ruling, a claim is invalid for indefiniteness “if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.”

In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., the issue of indefiniteness turned on the interpretation of the claim term “vitamin B12.” In this case, it was undisputed by the parties that the term “vitamin B12” as used in the specification can refer to either cyanocobalamin (a synthetic form of vitamin B12) specifically or, more broadly, to a class of compounds including pharmaceutical derivatives of cyanocobalamin. The patent defined vitamin B12 to mean “vitamin B12 and its pharmaceutical derivatives,” and that “[p]referably the term refers to vitamin B12, cobalamin, and chlorocobalamin. The parties also agreed that the term “vitamin B12” was used both ways in the specification.

Given these facts, one might think the claims were indefinite under the Nautilus standard. However, the CAFC determined that the claims were not indefinite in the context of the claims (which required administration to a patient), as one of ordinary skill in the art would understand that “vitamin B12” referred specifically to cyanocobalamin in the realm of medical treatment, thereby providing “reasonable certainty” as required under Nautilus.

Teva argued that because the claim term was used both ways in the specification, it was impossible to tell which meaning to use to interpret the scope of the claim with “reasonable certainty.” Lilly countered that the entire claim had to be considered in the indefiniteness inquiry and that since the claim specified administering “a vitamin B12 supplement to a patient,” one of ordinary skill in the art would know that the term referred to cyanocobalamin (which is the form used for human administration). Lilly supported this argument with expert testimony (which was not refuted, and in some ways confirmed, by Teva’s expert).

Understandings that lie outside the patent documents about the meaning of terms to one of skill in the art or the science or state of the knowledge of one of skill in the art are factual issues.

Importantly, the CAFC placed significant weight on the District Court’s use of the expert testimony on the issue and concluded that it found no clear error in the District Court’s conclusion that “vitamin” B12, when used to refer to vitamin B12 supplementation in a medical context, refers to cyanocobalamin.” The court distinguished Teva v. Sandoz on the grounds that the claim term at issue in that case did “not have a plain meaning to one of skill in the art that could be determined from context,” noting the expert admitted that the claim term had “no default meaning” (in contrast to the facts in the present case). In Teva v. Sandoz, the CAFC gave deference to the District Court’s subsidiary factual findings under the clear error standard set forth by the Supreme Court, but reviewed the application of the subsidiary factual findings as applied to the ultimate legal determination of indefiniteness de novo (without deference to the District Court). Because the expert testimony failed to provide reasonable certainty as to the meaning of the claim term, the CAFC found the claims indefinite, reversing the District Court.

The court also considered claim differentiation as supporting a clear meaning for “vitamin B12.”  Claim 1 listed both “vitamin B12” and cyanocobalamin (the asserted definition of “vitamin B12”) in claim 1 as suitable agents for use in the method (along with several other vitamin B12 derivatives). Claim 2 limited the agent to “vitamin B12” alone. The CAFC reasoned that since claim 2 specifically referred to “vitamin B12” alone, reading vitamin B12 as referring to a class of compounds would make claim 2 the same scope as claim 1. The court dismissed claim redundancy considerations, based on part on the prosecution history, having no issue with the claim 1 reciting cyanocobalamin twice in the claim.

This case illustrates the importance of expert testimony when fighting an indefiniteness challenge. It is critical that when expert testimony is presented regarding the meaning of a claim term, the testimony address the meaning of the term in the context of the claims to provide the public with reasonable certainty as to the meaning of the claim term in the context of the claims. If successful, the CAFC will have less flexibility in reversing factual determinations made by a District Court based on expert testimony.

Prosecution Disclaimer Has No Teeth

Prosecution Disclaimer Has No TeethStatements made by patent practitioners to the patent office during patent prosecution can come back to bite you in related applications. Prosecution disclaimer allows a court to limit the literal scope of the claims in an infringement action. For prosecution disclaimer to attach, the accused infringer bears a heavy burden in asserting it: “the disavowal must be both clear and unmistakable.”

The patents at issue in MIT v. Shire cover methods for growing organs in vivo as an alternative to organ transplantation. Prior art methods for making thin organs such as skin were not useful for making thicker organs because cells at the center of the developing organ tended to die due to decreased diffusion of oxygen and nutrients to those cells. MIT scientists developed a “biodegradable, synthetic matrix that provides[s] support for cell growth applicable to tissue engineering for vascularized organs,” the subject of U.S. Patents 5,770,193 and 5,759,830.

MIT sued Shire for patent infringement, alleging that Shire’s Dermagraft® scaffold infringed the ‘193 and ‘830 patents. Shire asserted the doctrine of prosecution disclaimer as to three terms, but the opinion focused primarily on “vascularized organ tissue.” If vascularized organ tissue was construed to include skin, then Shire could be liable for infringement. It was undisputed that the ordinary meaning of vascularized organ tissue included skin and the ‘193 and ‘830 disclosures support that. However, Shire asserted that under the doctrine of prosecution disclaimer, vascularized organ tissue should be construed to exclude skin.

During the prosecution of the parent application 06/933,018, MIT attempted to overcome a prior art rejection by arguing that the prior art was limited to use for skin and could not be used for other organ equivalents. The examiner maintained the rejection over several office actions, eventually forcing MIT to limit the claims in the parent application to “scaffolds for growing ‘non-skin organ cells,’” that the examiner rejected as constituting new matter. MIT abandoned the ‘018 application and continued to prosecute the related ‘193 and ‘830 applications. Both included the same non-skin limitation. MIT eventually replaced the non-skin limitation with a limitation directed to the thickness of the claimed cell mass, which earned MIT another new matter rejection under § 112. In the end, MIT removed the thickness limitation and added the limitation “to produce functionalized organ tissue in vivo.”

Shire offers several statements made by MIT as evidence of prosecution disclaimer. The opinion discusses each in turn, but the most unambiguous statements were related to the “non-skin” claim limitation and the inventor’s declaration.

Shire points to the non-skin claim amendment as evidence of disclaimer, but the court found that this amendment did not overcome the presumption that vascularized organ tissue had an ordinary and customary meaning. Although the claim amendment clearly disavowed claim scope that would include skin, the court found that because the amendment was made in connection with different claims—the claims at the time did not recite vascularized organ tissue— then disclaimer did not attach.

Shire also pointed to a declaration, where the inventor stated that prior art methods were “limited to a very thin layer of cells” and that “the claimed method is not a method for making very thin structures.” The court was not persuaded that these statements constituted disclaimer because the statements were offered in support of the thickness limitation. The thickness limitation does not recite vascularized organ tissue, so disclaimer did not attach.

It is a rarity to prevail on a prosecution disclaimer argument in the courts. Practically speaking, the “clear and unmistakable” disavowal means that the statements by the patentee were made to overcome an examiner’s rejection and the PTO was persuaded to allow the claims. If it’s a losing argument—the examiner maintains the rejection or issues a new rejection in response—then there is no harm, no foul. Most importantly, the statements must be made in connection with the exact disputed claim terms for disclaimer to attach.

You’ll Have To Be More Specific When Crafting That Generic Claim

You’ll Have To Be More Specific When Crafting That Generic ClaimRecent § 101 jurisprudence regarding tech inventions can be distilled down to two words: be specific. That’s a problem for patents in the tech space, because they are not specific at all, claiming inventions using broad functional language. Prior to Alice, for inventions where the function was novel but the components were not, a claim could recite an invention in terms of what the components did. Post-Alice, claims expressed in purely functional terms are likely to be held invalid under § 101 if the patent is litigated. This is exactly what happened to Affinity in Affinity Labs of Texas v. Amazon.com, Inc.

Affinity sued Amazon, alleging that the marketing of Amazon’s music systems infringed U.S. Patent No. 8,688,085. The district court and the Federal Circuit treated Claim 14 as representative. Rather than recite the lengthy Claim 14, we refer to the description provided by the Federal Circuit: “a network-based media system with a customized user interface, in which the system delivers streaming content from a network-based resource upon demand to a handheld wireless electronic device having a graphical user interface.”

The magistrate judge and the district court agreed that the ‘085 patent was directed to an abstract idea: “delivering selectable media content” and “playing [that content] on a portable device.” It was also found that the individual components of the media system, the “network based media system” and the “non-transitory storage medium” were a generic database and memory, respectively. Affinity argued that the “user interface” limitation provided the inventive concept, but the magistrate judge disagreed because neither the claim nor the specification identified “any specific technology or instructions that explain how the device can do what it purports to do or direct the practitioner how to carry out the claims.”

Applying step one of the Alice/Mayo analysis to Claim 14, the Federal Circuit agreed with the district court. The “purely functional nature of the claim confirm[ed] that it is directed to an abstract idea.” The court emphasized that neither the claims nor the specification disclosed a specific means for performing the claimed function—streaming content to a wireless device.

Affinity argued that the embodiments of the “customer user interface” listed in the specification, including a radio dial, a playlist, and targeted advertising based on demographic information provided by the user, were means for performing the claimed function as required under § 101. The court was not persuaded. Citing Intellectual Ventures v. Capital One Bank, where the court held that “customizing information based on . . .  information known to the user” was an abstract idea, the court concluded that Claim 14 was similarly directed to an abstract idea.

As to the second step of the analysis, the court did not find anything in the claims or specification constituting a “concrete implementation of an idea” (inventive concept). The claims did not disclose the “significantly more” required by Alice by failing to recite, for example, a solution for a technological problem; an improvement in the functioning of a computer or network; or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. The individual components, namely the network-based media system, the non-transitory storage medium, and the user interface, were claimed in purely functional, general terms: “[t]he features set forth in the claims are described and claimed generically rather than with the specificity necessary to show how those components provide a concrete solution to the problem addressed by the patent.” The court found no concrete implementation of the idea in the specification either, citing boilerplate language that the media system was not limited to any specific configuration and the statement that the user interface could be customized in a plurality of ways as examples of the vagueness of the disclosure.

A cursory reading of this case would indicate that the lack of concrete implementation of the idea should really be an indefiniteness (§ 112) issue rather than a § 101 issue. The invention is arguably “new and useful” as § 101 requires; the ‘085 patent was issued in 2014, but the priority date was 2000, a time when wireless streaming of media was not “routine, conventional, or well-known.” In light of the fact that the court remains committed to treating this as a § 101 issue, then practitioners would be wise to avoid purely functional claiming as it is a red flag to the courts. Practitioners should also provide a reasonable amount of detail in the specification, describing inventions as technological solutions to technological problems, if possible.

Does Yeda v. Abbott Clarify Inherent Disclosure Under 35 USC 112

Does Yeda v. Abbott Clarify Inherent Disclosure Under 35 USC 112Recently, in Yeda Research and Development v Abbott GMBH & Co. KG, the U.S. Court of Appeals for the Federal Circuit (CAFC) weighed in on the issue of inherent disclosure as a means for satisfying the written description requirement under 35 USC 112. The patent at issue in this case is U.S. Patent No. 5,344,915, which claims a protein termed TBP-II. TBP-II plays a role in various immunological diseases.

The ‘915 patent had a filing date of May 4, 1990, but claimed priority to two German patent applications filed May 9, 1989, and July 5, 1989. During prior litigation at the PTAB and district court, it was stipulated by the parties that a prior art reference (Engelmann, having a prior art date of January 1990) provided an anticipating disclosure if the priority date of at least one of the prior applications was not recognized. The written description issue centered on the adequate support from the claimed amino terminal sequence of TBP-II claimed in the ‘915 patent.

Claim 1 of the ‘915 patent reads:

A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence:

Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu, where Xaa is hydrogen, a phenylalanine residue (Phe), or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

Disclosure of the Priority Documents

Both of the priority documents disclosed partial amino acid sequences of the amino terminal fragment. The ‘072 application disclosed a 15 amino acid sequence, with eight of the amino acids residues being identified as disclosed in the ‘915 patent, six of the amino acids residues being defined as unknown (with likely assignments given to five residues) and the Xaa position being defined with a generic structure. The ‘089 application disclosed the first 13 amino acids claimed in the ‘915 patent but gave no disclosure of the final three amino acids.

Therefore, the priority documents did not disclose the entire amino terminal sequence of TBP-II as claimed in the ‘915 patent and were limited to partial amino terminal sequences. Both priority documents disclosed methods for obtaining TBP-II and certain properties of TBP-II (such as molecular weight, biological activity and the like). The parties also stipulated that the only protein containing the amino terminal sequence set forth in the earliest priority document (‘072) was TBP-II.

CAFC Analysis

The CAFC explained the legal standards for written description support under section 112. The court cited Kennecott Corp. (Fed. Cir 1987) for the proposition that in order for the claims of a later filed patent to benefit from the filing date of a prior application, the “claimed invention must be disclosed” by the prior application. Regarding the sufficiency of the disclosure required, the court cited Ariad Pharmaceuticals (Fed. Cir. 2010), stating the “invention must be disclosed in a way that clearly allows a person of ordinary skill to recognize that the inventor invented what is claimed and possessed the claimed subject matter at the date of filing.” Interestingly, the CAFC did not cite its prior case law regarding the stringency with which a disclosure must be made to support inherent anticipation under section 102. For inherent anticipation, the standard for a sufficient disclosure is the inherent feature “is necessarily present in the prior art document” and mere probability or possibility of the existence of the inherent feature is not enough.

When a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.

Yeda argued that the correct standard for the sufficiency of written description requires a showing that at the time of filing of the priority document, one of ordinary skill in the art would have understood the partial amino acid sequence disclosed included the amino acids identified in the later filed application (a concept which has been expressly rejected under the inherent anticipation case law). The CAFC dismissed this argument, stating that “when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.” The CAFC appeared to place great weight on the fact that the disclosure of the priority documents was sufficient to specifically identify TBP-II. In other words, since the priority documents uniquely identified a single protein (through partial sequence, functional characterization and physical characterization), any missing elements of the protein could be said to be inherently disclosed by the priority documents. Restated, one could say the disclosure of the more complete amino terminal sequence of TBP-II is a “deliberate or necessary consequence” of the priority documents disclosure.

The CAFC distinguished two prior decisions cited by Yeda (Hyatt v. Boone and In re Wallach) on the basis that neither of these cases described a case where an earlier application described “the exact invention claimed by the later patent.” Interestingly, In re Wallach claimed a nucleic acid encoding the full-length TBP-II protein based on the disclosure of a partial amino acid sequence and description of the physical characteristics of the protein (part of a series of cases filed by Yeda covering the technology at issue in this case). The applicant argued that since the full amino acid sequence of the protein was an inherent feature of the protein, the claims to the nucleic acid were adequately supported. The CACF disagreed with this proposition in 2004 stating that the disclosure of a partial amino acid sequence did not unambiguously determine the nature of the full-length nucleic acid encoding the protein (Yeda ultimately obtained claims for a nucleic acid sequence to the partial amino acids it disclosed).

Conclusions

While this case may be viewed as a liberal application of the inherency standard, given the disclosure of the ‘089 application explicitly disclosed 13 of the 16 amino acids claimed in the ‘915 patent and the fact that the priority documents uniquely identified the protein of interest, the decision of the court may be easier to understand. This decision is likely to be limited to the facts described in this case, namely applying only when the later claimed application can be shown to claim the exact invention disclosed in the priority document.

In any event, this case provides additional arguments for a lenient application of inherent disclosure and broadens the scope for written description support from a priority document.  However, the conclusion in In re Wallach and this case appear to be slightly at odds with one another. Is there a limit to the amount of disclosure that can be said to be inherently disclosed by a priority document? Could Abbott have obtained a claim for a full length nucleic acid sequence encoding TBP-II based on the holding of this case? Finally, do the claims held allowable in this case survive a section 101 analysis? This issue was not raised by the parties.

MRCO v. Bandai Shows the Way to Broader Method Claims that Satisfy Alice and Mayo

MRCO v. Bandai Shows the Way to Broader Method Claims that Satisfy Alice and MayoIt is said that one should cast a “wide net to catch the big fish.” In patent parlance, the wide net is the claims and the big fish are the competitors and customers. The computer/software industry and diagnostic industry, among others, generally rely on method claims to protect IP. However, method claims in these areas typically face increased scrutiny under the patent eligibility standard set forth in 35 USC §101 due to the nature of the claims (covering subject matter that may be considered abstract ideas, laws of nature, or natural phenomena).

To pass muster under §101, the claims must satisfy the Alice/Mayo framework set forth by the U.S. Supreme Court. The Alice/Mayo framework asks two questions: (1) are the claims directed to a patent-ineligible concept such as an abstract idea, law of nature, or natural phenomenon; and if so, (2) do the steps when considered individually and as an ordered combination transform the nature of the claim into a patent-eligible application. The Federal Circuit (CAFC) has also stressed the possibility of preemption as “the concern underlying the exceptions to §101.”

Previous CAFC cases have given important pointers on how to satisfy the Alice/Mayo framework. For example, in Enfish the CAFC found claims directed to an improved relational databased eligible under §101 as directed to an improvement in the operation of a computer. In Enfish, the courts specifically noted that the claims set forth a specific method by which the relational database operated and cited this factor as one that favored patentability of the claims. Enfish represented the first instance where the CAFC held a software claim was not directed to an abstract idea. In making this determination, the court noted specifically how the claims were limited to the specific methods in which the database structures were improved. In being so limited, the claims were clearly not focused on claiming an abstract idea or general concept but rather an improvement. While providing for eligibility of the claims, the opinion seemed to indicate such claims should be narrowly focused and contain clear limitations on how the concept claim is implemented.

As a result, even when method claims are found to be allowable the scope of the method claims may be limited to specific implementations of the method that were reduced to practice.

The CAFC, in MRCO v. Bandai, sets guidelines under which broad method claims, in this case software claims, are properly analyzed under the Alice/Mayo framework of §101 and opens the door to broad method claims.

The Prior Art and the Invention

In MRCO, the patents-at-issue, US 6,307,576 (‘576 patent) and US 6,611,278 (‘278 patent), relate to automating particular steps of a preexisting 3-D animation method. The preexisting 3-D animation method used multiple 3-D models of a character’s face to represent the different facial expressions the character makes when making certain sounds, termed “morph targets.” The resting facial expression was termed the “neutral model.” The morph target and the neutral model were characterized by certain points (vertices) on the face. The transition from the neutral model to a morph target was characterized by a “delta set” of vectors which represented the change in location of vertices between the neutral model and the morph target. To create the animation sequence, an animator manually assigned the “morph weight set” value between 0 and 1 at certain critical times (keyframes) following a time-aligned phonetic transcript. As such, the prior art methods relied heavily on the animator’s subjective judgment.

The invention was directed to automation of this task, specifically by determining when to set

keyframes and setting those keyframes without the input of the animator. The automation is accomplished through rules that are applied to the timed transcript to determine the morph weight outputs. While the specification provided many exemplary rule sets, they presented those rules in a broad form.

Claim 1 of the ‘576 patent is representative of the claims exampled and reads:

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

  • obtaining a first set of rules that define output morph weight set stream as a function of phoneme sequence and time of said phoneme sequence;
  • obtaining a timed data file of phonemes having a plurality of sub-sequences;
  • generating an intermediate stream of output morph weight sets and a plurality of transition parameters between two adjacent morph weight sets by evaluating said plurality of sub-sequences against said first set of rules;
  • generating a final stream of output morph weight sets at a desired frame rate from said intermediate stream of output morph weight sets and said plurality of transition parameters; and
  • applying said final stream of output morph weight sets to a sequence of animated characters to produce lip synchronization and facial expression control of said animated characters.

As is obvious from the claims, the manner in which the various rules are implemented is not recited in the claims.

District Court Invalidates the Claims

The district court held that the claims were not patent eligible under §101. While recognizing the claims at issue were not clearly drawn to an abstract idea (finding the directed to a specific technological process), the district court was concerned that the entire field of automated lip synchronization would be preempted because the claims are not limited to specific rules by which the methods described by the claims are carried out (as was the case in Enfish).

Classification as an Abstract Idea Dependent on the Actual Language of the Claims

The CAFC took issue with the district court’s oversimplified characterization of the claims. This is in agreement with the Alice Court which cautioned that “describing the claims at such a high level of abstraction and untethered from the language of the claims all but ensures that the exceptions to §101 swallow the rule.” Defendants argued that MRCO’s method claims “simply use a computer as a tool to automate conventional activity,” similar to the programmed alarm system of Flook. The Federal Circuit disagreed, stating that the claimed method was unlike the methods in Flook, Bilski, and Alice because the prior art method carried out manually by the animators was not the same as the claimed computer-implemented method. The CAFC found the patented methods “improved the existing technological process” by automating the animator’s task (the determination of the morph weigh sets), but did so in a way not taught or suggested in the prior art. The claimed methods defined the morph weight sets as a function of the timing of phoneme sub-sequences, something not taught or suggested in the prior art. In short, the CAFC found that “the claims are limited to rules with specific characteristics” despite the fact the rules were broadly and categorically claimed. The court noted that while such a broad claim approach increases the risk of preemption, this does not mean that such claims are unpatentable.

Regarding potential preemption concerns, the defendants argued that the claims would prohibit any automated method of using the rules-based lip-synchronization process. The CAFC noted that the art was aware of alternative methods for automating lip-synchronization and that the claims at issue only cover methods that defined the morph weight sets as a function of the timing of phoneme sub-sequences. Therefore, other methods were available for an automated rules-based lip-synchronization process.

The CAFC’s decision in MRCO provides guidance on how to navigate the difficult path between obtaining claims of broad scope while maintaining eligibility under §101. First, as was stressed in prior cases, discuss in the specification how the claims are directed to a specific improvement in a technological process and clearly articulate the advantages of the claimed methods. Second, clarify that the claimed methods do not preempt other solutions to the same technical problem.

The approach taken by the CAFC here should also be applicable to other technological areas as well. Consider claims to diagnostic methods using a particular biomarker or natural relationship.  Showing that the claimed use of the biomarker does not preempt all uses of the biomarker should provide a foundation on which to argue the claims are patent eligible under the existing §101 jurisprudence.

Roadmap to Software Patent Eligibility – Continued

Roadmap to Software Patent Eligibility - ContinuedRecent Federal Circuit cases provide direction on how to satisfy the PTO or the federal courts that software is eligible for a patent. Some key points include:

  • New ways of organizing data
  • New connections between modules of data
  • New ways of providing access to data
  • New locations on a computer or network for operations previously known
  • Deletion of steps previously used in the prior art
  • The outcome of the above results in faster searching, more effective storage of data such as using less space, more flexibility in the organizing and use of the data

In addition to the Enfish case, another recent case, Bascom Global Internet Services, Inc. v. AT&T Mobility LLC, also held the software invention in patent 5,987,606 to be patent-eligible, but it was a closer question than in Enfish.

The claimed invention provides individually customizable filtering at a remote Internet Service Provider (ISP) server by taking advantage of the technical capability of certain communication networks. In these networks, the ISP is able to associate an individual user with a specific request to access a website (or other Internet content), and can distinguish that user’s requests from other users’ requests. One way that the ISP is able to make this association, as described in the ’606 patent, is by requiring each user to first complete a log-in process with the ISP server. After a user has logged in, the ISP server can associate the user with a request to access a specific website (“In the TCP/IP protocol, each Internet access request or ‘packet’ includes the [website] from which content is requested”). Because the filtering tool on the ISP server contains each user’s customized filtering mechanism, the filtering tool working in combination with the ISP server can apply a specific user’s filtering mechanism to the websites requested by that user. To summarize, the ISP server receives a request to access a website, associates the request with a particular user, and identifies the requested website. The filtering tool then applies the filtering mechanism associated with the particular user to the requested website to determine whether the user associated with that request is allowed access to the website. The filtering tool returns either the content of the website to the user, or a message to the user indicating that the request was denied. This patent describes its filtering system as a novel advance over prior art computer filters, in that no one had previously provided customized filters at a remote server.

The patent owner argued that the claims are directed to the specific implementation of filtering content set forth in the claim limitations. Specifically, it argued claim 1 is “directed to the specific problem of providing Internet-content filtering in a manner that can be customized for the person attempting to access such content while avoiding the need for (potentially millions of) local servers or computers to perform such filtering and while being less susceptible to circumvention by the user.” Claim 23 is directed to the even more particular problem of structuring a filtering scheme not just to be effective, but also to make user-level customization remain administrable as users are added instead of becoming intractably complex. The Federal Circuit, however, found that the patent’s disclosure and the claims were directed to an abstract idea, i.e., data filtering.

The Court’s finding was not the end of the analysis, however, as even abstract ideas can be patentable if “an inventive concept” is claimed specifically if it claims “significantly more than the abstract idea itself, and is not merely an instruction to implement or apply the abstract idea on a computer.”

The Court found that the inventive concept is the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user. This design gives the filtering tool both the benefits of a filter on a local computer and the benefits of a filter on the ISP server. The inventive concept rests on taking advantage of the ability of at least some ISPs to identify individual accounts which communicate with the ISP server and to associate a request for Internet content with a specific individual account. For example, FIG. 3 of the ‘606 patent shows the ISP server 100 process for accepting a log-in request 200; the ISP server 100 first verifies 201 whether the user is a registered subscriber. In the TCP/IP protocol, each Internet access request or ‘packet’ includes the website from which content is requested. The inventive concept harnesses this technical feature of network technology in a filtering system by associating individual accounts with their own filtering scheme and elements while locating the filtering system on an ISP server.

The claims do not merely recite the abstract idea of filtering content along with the requirement to perform it on the Internet or to perform it on a set of generic computer components. Nor do the claims preempt all ways of filtering content on the Internet; rather, they recite a specific, discrete implementation of the abstract idea of filtering content. Preemption is a very important question, asking whether the patent’s claims would prevent all methods of filtering. Filtering content on the Internet was already a known concept, and the patent describes how its particular arrangement of elements is a technical improvement over prior art ways of filtering such content.

Claim 1 of the Bascom patent provides a content filtering system for filtering content retrieved from an Internet computer network by individually controlled access network accounts, said filtering system comprising:

  • A local client computer generating network access requests for said individually controlled access network accounts;
  • At least one filtering scheme;
  • A plurality of sets of logical filtering elements; and
  • A remote ISP server coupled to said client computer and said Internet computer network, said ISP server associating each said network account to at least one filtering scheme and at least one set of filtering elements, said ISP server further receiving said network access requests from said client computer and executing said associated filtering scheme utilizing said associated set of logical filtering elements.

Additional discussion of the Roadmap to Software Patentability from another new case can be found here.

Roadmap to Software Patent Eligibility

Roadmap to Software Patent EligibilityRecent Federal Circuit cases provide direction on how to satisfy the PTO or the federal courts that software is eligible for a patent. Some key points include:

  • New ways of organizing data
  • New connections between modules of data
  • New ways of providing access to data
  • New locations on a computer or network for operations previously known
  • Deletion of steps previously used in the prior art
  • The outcome of the above results in faster searching, more effective storage of data such as using less space, more flexibility in the organizing and use of the data

The first of these cases, and the most definitive, is Enfish, LLC v. Microsoft which involved patent 6,151,604 disclosing software for a “self-referential database.” The invention was distinguished from a “relational database” in which each type of thing which is modeled is provided in a separate table, such as for a document, person or company. A prior art database might store a document called project.doc, a person called Scott Wlachsin or a company as depicted below left. To indicate that Scott Wlachsin is the author of proj.doc and is employed by Dexis, the relational database uses relationships as depicted below right. The topmost relationship shows that the value for “Author” in the Document table refers to the “ID” column of the Person table. Because the row for proj.doc has AUTHOR=1, the row in the Person table that has ID=1 is the author of proj.doc. The relational database captures information about each item in a separate table and creates relationships informing the connections between rows in different tables.

Roadmap to Software Patent Eligibility

The patented invention, however, has two features which are different: (1) storing all entity types in a single table, and (2) defining the table’s columns by rows in the same table, as seen here:

Roadmap to Software Patent Eligibility

An additional row is included in the self-referential table, the row beginning with ID = #4. This row has values of TYPE = “field” and LABEL = “Employed By.” A row with TYPE = “field” is a special row because it defines characteristics of a column in that same table. The row with ID = #4 corresponds to the penultimate column, which is denoted by also marking that column with the ID of #4. The row with ID = #4 defines a single characteristic of the corresponding column, i.e., its label. Because the row with ID = #4 has LABEL = “Employed By,” we know that the corresponding column is labeled “Employed By,” as seen in the penultimate column. In other situations, the row might define other characteristics of the column, such as the type of data that the column can hold, e.g., text, integer numbers, or decimal numbers. Because the patent describes a model where the table’s columns are defined by rows in that same table, it is “self-referential” (see ’604 patent, col. 2, ll. 59–65).

The new invention claimed faster searching of data, more effective storage, and more flexibility in configuring the database on-the-fly instead of extensive modeling before launching the database. As to flexibility, the database could be launched with no or only minimal column definitions. Then, as a new attribute of information is encountered, such as an email address, an “Email” column could be added simply by inserting a new row of TYPE = “field” and LABEL = “email.” The addition of this new row can then instigate the database to create a new corresponding column. The addition of a new row-defining-a-column to the previous example might result in the following:

Roadmap to Software Patent Eligibility

The Enfish Court said the first step in its inquiry is to ask whether the focus of the claims is on the specific asserted improvement in computer capabilities (i.e., the self-referential table for a computer database) or, instead, on a process that qualifies as an “abstract idea” for which computers are invoked merely as a tool. The Court held “the plain focus of the claims is on an improvement to computer functionality itself, not on economic or other tasks for which a computer is used in its ordinary capacity.” The claims “are directed to a specific improvement to the way computers operate, embodied in the self-referential table.” Again, “the claims are not simply directed to any form of storing tabular data, but instead are specifically directed to a self-referential table for a computer database” which “functions differently than conventional database structures.” The claims were for “a specific type of data structure designed to improve the way a computer stores and retrieves data in memory.” The situation was not “where general-purpose computer components are added post-hoc to a fundamental economic practice or mathematical equation. Rather, the claims are directed to a specific implementation of a solution to a problem in the software arts.” The claims were not “simply adding conventional computer components to well-known business practices.” In sum, the invention was not an abstract idea.

One of the representative claims approved by the Federal Circuit was a data storage and retrieval system for a computer memory, comprising:

Means for configuring said memory according to a logical table, said logical table including:

  • A plurality of logical rows, each said logical row including an object identification number (OID) to identify each said logical row, each said logical row corresponding to a record of information;
  • A plurality of logical columns intersecting said plurality of logical rows to define a plurality of logical cells, each said logical column including an OID to identify each said logical column; and
  • Means for indexing data stored in said table.

This is the kind of claim which will be allowed by the PTO and upheld by the federal courts, and is a go-by in developing the kind of information and strategy for a software patent application.

Additional discussion of the Roadmap to Software Patentability from another new case can be found here.

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