Patent Eligibility Pointers from the Federal Circuit – Part 2

In Part 1 of this post series, several decisions from the Court of Appeals for the Federal Circuit (CAFC) were analyzed to explore factors that may lead a court to find patent claims ineligible under §101. The cases discussed were Credit Acceptance Corp. v. Westlake Services (June 9, 2017), Prism Technologies LLC v. T-Mobile USA, Inc. (June 23, 2017), and Return Mail, Inc., v. United States Postal Service (August 28, 2017).

During this same period of time, the CAFC decided Visual Memory LLC v. Nvidia Corporation (August 15, 2017) in which the claims were found to be patent eligible under §101. As each of these cases was decided in a relatively narrow three-month window from June to August 2017, they offer insight into the logic of the CAFC in analyzing patent eligibility issues, particularly in regard to computer arts.

Part 2 of this post examines those factors in Visual Memory that the CAFC relied on in determining the claims were patent eligible under §101. While no one characteristic of a claim is outcome determinative, Visual Memory serves as a guidepost in drafting patent eligible claims.

Patent Eligibility Pointers from the Federal Circuit – Part 2The patent at issue in Visual Memory was US Patent No. 5,953,740. Claim 1 of the ‘740 patent was found to be representative (shown below).

A computer memory system connectable to a processor and having one or more programmable operational characteristics, said characteristics being defined through configuration by said computer based on the type of said processor, wherein said system is connectable to said processor by a bus, said system comprising:

  • a main memory connected to said bus; and
  • a cache connected to said bus;
  • wherein a programmable operational characteristic of said system determines a type of data stored by said cache.

The claims are directed to a computer memory system comprising at least one memory cache with the computer memory system having one or more “programmable operating characteristics” that are configured by the computer based on the type of processor contained in the computer. In essence, the cache element(s) are configured to store specific sets of data (for example, code data and non-code data) and/or communicate with specified components of the computer based on the type of processor contained in the computer. The specification provides several examples of specific programmable operational characteristics and how they are varied depending on processor type, as well as providing an appendix of computer code for carrying out such operations.

The district court, on a motion to dismiss for failure to state a claim, found claim 1 f the ‘740 patent was directed to the abstract idea of “categorical data storage” under step 1 of the Alice framework and found the claims did not recite inventive concepts under step 2 of the Alice framework. The district court held the “programmable operating characteristics” limitation represented only a generic concept that determined the type of data to be stored in the cache and the specification failed to explain the mechanisms for accomplishing the result.

The CAFC reversed, finding claim 1 of the ‘740 patent was directed to an improved memory system per se, as can be seen in the previous cases in this area, the specificity in which the claims are defined under the “directed to” inquiry is often dispositive of the ultimate patent eligibility issue.

In reaching this conclusion, the CAFC relied on several factors that led to a more specific description of the claims under the “directed to” inquiry mandated in step 1 of the Alice framework.  First, the court stressed that the specification described the benefits of the claimed computer memory system. The specification provided the advantages of computer memory system, such as allowing different processors to be used with the memory system without compromising the performance of either the processor or the memory system, as well as the improved performance of the claimed memory system in comparison to prior art memory systems.

To be clear, describing the benefits of the system alone is not always enough to obtain a favorable outcome under the “directed to” inquiry, as many prior cases have provided such descriptions and still found the claims characterized at a high level. However, a discussion of the benefits and advantages of the invention and how the invention overcomes problems noted in the art, particularly when specifically related to the claimed elements, gives a court the opportunity to resist a high-level characterization of the claims and provide a more specific description of what the claims are “directed to” under step 1 of the Alice framework. As noted in prior precedent, courts must “articulate with specificity what the claims are directed to” in order that the step 1 inquiry under the Alice framework is a meaningful one.

The court also noted that the focus of the claims was on the improvement to computer functionality itself in contrast to improvements in a method in which the computer is used only as a tool. In claim 1 above, note the claimed element “cache” is modified to store only a specific type of data by the “programmable operational characteristic” of the claim. The opinion drew analogies to the claims in Enfish (claiming a specified self-referential data table that improved the function of a computer) and Thales Visionix (claiming a unique configuration of two inertial sensors that improved the accuracy of the system). By focusing the claims on the claimed improvement, the content of the claims is linked to the description of the computer memory system and thereby, indirectly, to the benefits/advantage of the system.

Importantly, the claims at issue here and in Thales Visionix did not specify the exact method by which the invention was carried out. In this case, claim 1 did not specifically describe how the “programmable operating characteristic” determines the type of data stored by the cache. The same fact pattern was also present in MCRO where the claims described a generic rule set for animating lip synchronization and facial expression. The operational details and implementation were described in the specification, and to varying degrees, in the dependent claims in each of these cases.

While the specific description of how the object of the invention is carried out in the claims is not absolutely required, thought should be given to providing dependent claims providing such details when possible. Furthermore, the role of the specification is describing how the claimed invention is implemented cannot be underestimated. The dissent in this case argued that the term “programmable operational characteristic” was nothing more than a black box and the claims provided no meaningful limitations on how the “programmable operational characteristics” were implemented. In essence, the dissent argued that the claims failed patent eligibility, at least in part, for failure to satisfy the requirements of 35 USC §112. The majority stated that while §112 issues must be considered for patent validity, they are not a part of the §101 eligibility analysis (however, see a differing approach in dicta from Trading Technologies, a non-precedential decision). In short, while various panels have differing opinions on the role of written description/enablement issues in the patent eligibility analysis, using the specification to describe how the claims are implemented allows the patentee to address such issues if they arise.

Another aspect worth noting is that while the claims in Visual Memory recited “generic” computer elements (similar to the claims in Credit Acceptance Corp., Prism Technologies and Return Mail), the function of the generic computer elements in the current case was altered. Specifically, the cache element, while arguably generic, functioned in a different manner than the cache components of the prior art as a result of the modification implemented by the programmable operating characteristics. Contrast this with Credit Acceptance Corp., where the concept of linking two previously unlinked databases together to enhance the financing options was not enough to confer patent eligibility when each database functioned in an art-recognized manner. Courts are willing to find claims patent eligible even when the claims recite generic components when the claims are properly structured (see also Bascom).

What Can We Learn

A number of lessons can be gleaned from Visual Memory and the CAFC’s commentary on the claims.

  1. Use the specification to specifically describe the innovation(s) presented in the claims to avoid a high-level characterization of the claims at the directed inquiry of Alice step 1.
  2. Use the specification to describe the benefits of the claimed invention, with specific reference to the features claimed.
  3. Provide as much detail as possible on the operation of the claimed invention, with specific attention to the unique claim elements.
  4. Use the specification to tie the solution of art-recognized problems to specific elements identified in the claims.
  5. Describe any ways in which the claimed elements are modified as compared to corresponding prior art elements, emphasizing any new functions that result from the modification.
  6. Tailor the claims to support a specific characterization of the claims under the “directed to” inquiry of Alice step 1 based on the description in the specification.

While there are no guarantees when arguing patent eligibility, realizing the importance of the specification in setting up successful arguments for overcoming §101 rejections is critical.

Patent Eligibility Pointers from the Federal Circuit – Part I

What characteristics of a claim do the courts use to determine if a claimed invention meets the statutory requirements under 35 USC §101? This question has been vexing patent attorneys for years, with the question becoming more important in light of the Supreme Court’s decision in Bilski and its progeny. While no one characteristic of a claim is outcome determinative, review of the case law can provide guidance in drafting patent eligible claims.

Patent Eligibility Pointers from the Federal Circuit – Part IThe Court of Appeals for the Federal Circuit (CAFC) issued several recent decisions on patent eligibility for inventions directed to the computer arts from June to August of this year. As each of these cases were decided within three months of one another, they offer insight into the logic of the CAFC in analyzing the patent eligibility issue in the computer arts.

The cases discussed here are:

Each of these cases was deemed to recite patent eligible subject matter under §101. Part one of this post examines what these cases teach us about factors that lead a court to find patent claims ineligible under §101.

The CAFC also found patent claims to be eligible under §101 in Visual Memory LLC v. Nvidia Corporation (August 15, 2017). In part two of this post, we will examine the logic the CAFC found in finding these claims complied with the patent eligibility requirements.

Common Themes for Patent Ineligible Claims

In Credit Acceptance, Prism Technologies and Return Mail each CAFC panel echoed several common themes in finding that the claims did not meet the requirements of §101.

First, the CAFC noted that configuring a general purpose computer, even with specific instructions to accomplish a series of operations not previously implemented on a computer, in order to supplant or enhance an otherwise manual procedure is not enough under the §101 analysis. The panels viewed such claims, without more, as simply using the computer as a tool to conduct the process.

Second, each panel also stressed the claims at issue recited generic computer elements or processes and that no evidence was presented that the arrangement or use of the generic elements provided a benefit or improvement that trumped the conventional use of the elements. The CAFC noted that a unique arrangement of generic elements can be patent eligible (citing Bascom), but when the generic components perform the same function in the same manner as is known in the art, patent eligibility is in question. In Credit Acceptance Corp., the concept of linking two previously unlinked databases together to enhance the financing options was not enough to confer patent eligibility when the database functioned in an art-recognized manner.

Third, when claims use functional/generic language to carry out a claimed method or process, the details of how the process is carried out need to be disclosed, preferably in the claims (note that in Visual Memory the panel seemed willing to consider such details present in the specification only). The Credit Acceptance panel stressed that claims directed to a results-oriented solution that provide insufficient detail on how the solution is implemented fall short in terms of patent eligibility (citing Intellectual Ventures I).

Finally, arguments that the claimed methods solve an art-recognized problem are not likely to confer patent eligibility on the claims, absent something more (for example, a unique arrangement of generic computer elements). In Prism Technologies, the patent holder’s argument that the hardware identifiers combined with the generic elements provided a solution to an internet- centered problem was rejected based on the finding that the hardware identifiers functioned as was known in the art.

The message the CAFC is conveying appears to be that when the computer is used as a tool to conduct a fundamental activity (for example, facilitating a financial transaction), the claims or the specification are required to clearly describe how the function or arrangement of elements differs from what is art recognized.

What Can We Learn

The take-home from these four cases is that details are important and that the specification can be determinative in winning or losing the patent eligibility fight.

  1. Use the specification to provide a detailed description of how the claimed elements function in the claimed methods.
  2. Consider adding dependent claims to provide increasing levels of detail as to how the claimed methods are carried out.
  3. Use the specification to describe the benefits of the claimed invention, with specific reference to the features claimed.
  4. Use the specification to tie the solution of art-recognized problems to specific elements identified in the claims.
  5. Describe any ways in which the claimed elements function in a different manner or are arranged in a different manner than is art recognized.

While there are no guarantees on the patent eligibility battleground, realizing the importance of the specification in setting up successful arguments for overcoming §101 rejections can only be beneficial.

The second part of this post will compare the claims found patent eligible in Visual Memory to analyze why these claims were deemed to comply with the patent-eligibility requirements.

Lower Threshold for Indefiniteness Confirmed by PTAB in Ex Parte McAward

The courts have long stated that one goal of patent law is to provide certainty to both inventors and the public regarding the law that is applied in determining the metes and bounds of a patent claim. Patent claims that are ambiguous and vague in scope leave the public in doubt as to what is protected by the patent and is considered to exert a chilling effect on further innovation. What is one sure fire way to destroy certainty? Having two differing legal standards applied to claim interpretation seem to fit the bill. This is exactly the situation encountered when patent claims are evaluated for indefiniteness under 35 USC §112(b) by courts in the context of patent litigation and the Patent Trial and Appeal Board (PTAB) in pre- and post-issuance proceedings.

Lower Threshold for Indefiniteness Confirmed by PTAB in Ex Parte McAward

Differing Standards for Indefiniteness

District courts and the CAFC apply the now familiar standard for claim indefiniteness under Nautilus as set forth by the Supreme Court, 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.” Nautilus replaced the prior test for indefiniteness which required a claim to be “insolubly ambiguous.” The PTAB however has stated that it is not bound by the USSC’s decision in Nautilus. The PTAB standards for determining indefiniteness are whether a claim “contains words or phrases whose meaning is unclear” as set forth in In re Packard or “when a claim is amenable to two or more plausible constructions” as discussed in Ex Parte Miyazaki.

The PTAB explained in Ex Parte Miyazaki that in pre-issuance proceedings the board is justified in using a lower threshold “because the applicant has an opportunity and a duty to amend the claims during prosecution to more clearly and precisely define the metes and bounds of the claimed invention and to more clearly and precisely put the public on notice of the scope of the patent.”

The same standard has been applied in post-grant proceedings in Google, Inc. v. SimpleAir, Inc., where the board stated the basis for applying the lower threshold for indefiniteness in pre-issuance proceedings “stems from two factors: (1) the broadest reasonable interpretation claim construction standard; and (2) the lack of a presumption of validity before the Office.” As the board found the same two factors apply to post-grant proceedings, the lower standard for indefiniteness was proper. This approach was also confirmed in Tinnus Enterprises, LLV v. Telebrands Enterprises, where the board stated “We do not understand Nautilus, however, 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.”

As we discussed previously, these differing standards can result in different outcomes in the CAFC and the PTAB (Tinnus Enterprises, LLV v. Telebrands Enterprises).

Ex Parte McAward Confirms PTAB Approach in Pre-Issuance Proceedings

The PTAB issued a precedential decision, a rare occurrence, in Ex parte McAward on August 25, 2017 (link). The decision serves as clear confirmation that the PTAB will continue to use the lower threshold for indefiniteness as set forth in In re Packard and Ex Parte Miyazaki in pre-issuance proceedings. However, the board’s decision expressly limits the holding to pre-issuance proceedings, leaving some doubt as to the continued application of the lower standard to post-grant proceedings. Specifically, the board stated “We do not address, in this decision, the approach to indefiniteness that the Office follows in post-grant trial proceedings under the America Invents Act.” Therefore, until a precedential decision from the board addresses the application of the lower standard in post-grant proceedings, the proper standard for the evaluation of claim indefiniteness for post-grant proceedings is still in some doubt.

While the same factors relied on by the PTAB in applying the lower threshold are arguably present in post-issuance proceedings, the issue of how freely claim amendments are entered in post-grant proceedings has recently been called into question. In In re Aqua Products (CAFC, 2015-1177), the CAFC granted en banc review in December 2016 to determine if the board’s approach to claim amendments during post-grant proceedings is too limiting. While a decision still has not been handed down, if it is found that patent owners do not have the opportunity to freely amend their claims (as required by the logic of Google, Inc. v. SimpleAir, Inc. and Tinnus Enterprises, LLV v. Telebrands Enterprises) the PTAB’s logic in applying the lower standard is called into question, arguing that the proper standard for evaluating claim indefiniteness in post-grant proceedings should in fact be the Nautilus standard as applied by the district courts and the CAFC.

Points to Consider

For the present, it should be expected that the PTAB will continue with its current approach to evaluating claim indefiniteness in both pre- and post-issuance proceedings. As a result, it will remain the case that patent claims will be easier to invalidate on indefiniteness grounds in front of the board as compared to district court. While the situation may change with respect to post-grant proceedings, it is unlikely to change with respect to pre-issuance proceedings.

Therefore, those wishing to challenge claims on the ground of indefiniteness should carefully consider their options and consider taking advantage of the lower threshold available in front of the board. Likewise, patent applicants and owners should evaluate their cases for vulnerability under the PTAB’s current standards.

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.

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