Precedent Leaves No Room for Different Outcome; Method of Treating Specific Disease is Patent Eligible

In Endo Pharmaceuticals Inc., v. Teva Pharmaceuticals USA, Inc., [ 2017-1240, 2017-1455, 2017-1887](March 28, 2019), the Federal Circuit reversed the district court’s determination that the claims of U.S. Patent No. 8,808,737 ineligible under 35 U.S.C. § 101.

The ’737 patent, entitled “Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment” covers a method of using oxymorphone to treat pain in patients with impaired kidney function. The method adjusted the level of oxymorphone administered based upon the severity of the renal impairment.

The magistrate judge first analyzed step 1 of the Alice/Mayo test, reasoning that the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment. The district court adopted the magistrate judge’s recommendation, finding the patent claims ineligible.

At step one of the Alice/Mayo, the Federal Circuit said “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Applying this law, the Federal Circuit concluded that the asserted claims are not directed to patent-ineligible subject matter. On the contrary, the Federal Circuit found that the claims were directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient. This conclusion was supported by the claim language itself and confirmed by the specification, the claims, the abstract, patent title, and summary of the invention all describe the invention as a “method of treating pain” in patients with renal impairment.

The claims at issue here are legally indistinguishable from the representative claim in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018). Both claims recite a method for treating a patient. The Vanda patent claims recite the steps of carrying out a dosage regimen based on the results of genetic testing, while in the instant case the claims similarly recite the steps of carrying out a dosage regimen, though the steps are based on the results of kidney function testing. Additionally, the claims in both cases require specific treatment steps.

The Federal Circuit distinguished Mayo in part because the claims as a whole were not directed to the application of a drug to treat a particular disease. The Federal Circuit noted that the inventor here recognized the relationship between oxymorphone and patients with renal impairment, but that is not what he claimed. Rather, he claimed an application of that relationship—specifically, a method of treatment including specific steps to adjust or lower the oxymorphone dose for patients with renal impairment. The claims are thus directed to more than just reciting the natural relationship.

The Federal Circuit concluded that the ’737 patent claims are like those in Vanda. They are eligible because they are “directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Finding “[o]ur precedent leaves no room for a different outcome.”

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Products and Methods Employing Naturally Occurring Substances are not Necessarily Ineligible

In Natural Alternatives International, Inc. v. Creative Compounds, LLC, [2018-1295](March 15, 2019), the Federal Circuit reversed and remanded judgment on the pleadings that the asserted claims of U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376, 8,993,610, 8,470,865, and RE45,947
relating to dietary supplements containing beta-alanine, are not patent eligible.

The district purported accepted Natural Alternatives’ proposed claim constructions, in finding that the subject matter ineligible. However, the Federal Circuit found that the proposed claim constructions, we hold that the complaint’s factual allegations, together with all reasonable inferences, plausibly establish the eligibility of the representative claims. While the Method Claims have similarities to the claims found ineligible in Mayo, as they utilize an underlying natural law, this is not sufficient to establish that they are directed to that law. Under Natural Alternatives’ constructions, the Method Claims require specific steps be taken in order to bring about a change in a subject, altering the subject’s natural state.

The Federal Circuit said that like the claims in Vanda, the Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law. Like the Vanda claims, which specify a patient population to be treated, the Method Claims specify particular results to be obtained by practicing the method. The Federal Circuit also noted that while beta-alanine may exist in nature, Natural Alternatives has argued that the quantities being administered do not, and that the claimed consumption greatly exceeds natural levels.

The Federal Circuit concluded that the Method Claims at issue are treatment claims. They cover using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages outlined in the patents. The Federal Circuit held that the Method Claims are not directed to ineligible subject matter.

The Federal Circuit further noted that at step two, factual impediments exist to resolving the case at this stage.

As to the product claims, the Federal Circuit noted that although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine. The Federal Circuit said that a claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and “the potential for significant utility.” At this stage in the litigation, the Federal Circuit found that it has been sufficiently alleged that these characteristics provide significant utility, as the claimed dosage forms can be used to increase athletic performance in a way that naturally occurring beta-alanine cannot. Accordingly, neither claim is directed to ineligible subject matter.

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Fact that Invention can “result in life altering consequences,” is Laudable, but it Does not Render it any Less Abstract

In University of Florida Research Foundation, Inc., v. General Electric Company, [2018-1284] (February 26, 2019), the Federal Circuit affirmed the determination that the claims of U.S. Patent No. 7,062,251 are directed to ineligible subject matter under 35 U.S.C. § 101.

At the outset, the Federal Circuit determined that the University of Florida Research Foundation waived its sovereign immunity claims by suing General Electric in the first place.

The ’251 patent describes a method and system for integrating physiologic data from at least one bedside machine. At Alice step one, the district court determined the claims are directed to the abstract idea of “collecting, analyzing, manipulating, and displaying data.” At Alice step two, the district court found that the claims did not recite an inventive concept.

The Federal Circuit agreed that the claims were ineligible, noting the ’251 patent seeks to automate “pen and paper methodologies” to conserve human resources and minimize errors. The Federal Circuit said that it was a quintessential “do it on a computer” patent: it acknowledges that data from bedside machines was previously collected, analyzed, manipulated, and displayed manually, and it simply proposes doing so with a computer. We have held such claims are directed to abstract ideas.

The Federal Circuit noted that the fact that the automation can “result in life altering consequences,” is laudable, but it does not render it any less abstract. The Federal Circuit noted that neither the ’251 patent, nor its claims, explains how the drivers do the conversion that UFRF points to. The drivers are described in purely functional terms: they “facilitate data exchanges,” “convert received data streams to a format independent of any particular bedside machine,” “translate the data stream,” “interpret data streams,” “facilitate communications with the bedside machine,” and “interpret [discrete] segments” in a “data stream for the machine.” The Federal Circuit said that the ’251 patent “fails to provide any technical details for the tangible components, . . . instead predominately describ[ing] the system and methods in purely functional terms.” The Federal Circuit concluded that at Alice step one that representative claim 1 is directed to the abstract idea of “collecting, analyzing, manipulating, and displaying data,” and observing the claims fare no better at Alice step two.

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Diagnostic Method Ineligible; Patent Law Once Again Fails to Promote the Progress of Science

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, [2017-2508] (February 6, 2019), the Federal Circuit affirmed the district court’s holding that claims 6–9 of U.S. Patent 7,267,820 (the “’820 patent”) are invalid under
35 U.S.C. § 101 and dismissing Athena’s complaint under Rule 12(b)(6).

The inventors discovered the association between MuSK autoantibodies
and Myasthenia gravis, and in the ’820 patent disclosed and claimed methods of diagnosing neurological isorders such as MG by detecting autoantibodies that bind to a MuSK epitope.

The Federal Circuit agreed that the claims were directed to a natural law, specifically, the correlation between the presence of naturally-occurring
MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG. The Federal Circuit said “This correlation
exists in nature apart from any human action. There can
thus be no dispute that it is an ineligible natural law.”

The Federal Circuit concluded that the claims were directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law. This finding was bolstered by the truthful but unfortunate statements in the specification that “[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art.”

The Federal Circuit said: “The claims here are directed to a natural law because they recite only the natural law together with standard techniques
for observing it. That the routine steps are set forth with some specificity is not enough to change that conclusion.”

Finally, the Federal Circuit rejected Athena’s argument that the claims were patentable because they required labeling MuSK with a manmade
substance, finding that the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.

At step II of the aptly named Mayo test, the Federal Circuit found that the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only required standard
techniques to be applied in a standard way. This was bolstered by the specification’s description of the steps as “conventional techniques.” The Federal Circuit refused to hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept.

Posted in 101

A Patent on Games? No Dice.

In In re Marco Guldenaar Holding B.V., [2017-2465](December 28, 2018), the Federal Circuit affirmed the decision of the PTAB affirming the rejection of claims 1–3, 5, 7–14, 16–18, and 23–30 of U.S. Patent Application No. 13/078,196 under 35 U.S.C. § 101 for claiming patent-ineligible subject matter.

The application, entitled “Casino Game and a Set of Six-Face Cubic Colored Dice,” relates to dice games intended to be played in gambling casinos, in
which a participant attempts to achieve a particular winning combination of subsets of the dice.

The Examiner concluded that the claims were directed to the abstract idea of “rules for playing a game,” which fell within the realm of “methods of organizing human activities.” The examiner also
concluded that the claims were unpatentable for obviousness over U.S. Patent No. 4,247,114 over matters old and well known to dice games, applying the printed matter doctrine. The Board affirmed both rejections.

The Federal Circuit found its decision in In re Smith, 815 F.3d 816 (Fed. Cir. 2016), where it found a method of conducting a wagering game using a
deck of playing cards was drawn to an abstract idea, to be “highly instructive.” In the present case, as in In re Smith, the claims were directed to a method of conducting a wagering game, but using dice instead of cards. with the probabilities based on dice rather than on cards.

The Federal Circuit agreed with Applicant/Appellant that the USPTO’s category of unpatentable subject matter “methods of organizing human activities” can be confusing and potentially misused, but where the decision further articulates a more refined characterization of the abstract idea (e.g., “rules for playing games”), there was no error in also observing that the claimed abstract idea is one type of method of organizing human activity.

The Federal Circuit said that abstract ideas, including a set of rules for a game, may be patent-eligible if the claims contain an inventive concept sufficient to transform the claimed abstract idea into a patent-eligible application. On appeal, Applicant/Appellant contended that the specifically-claimed dice that have markings on one, two, or three die faces are not conventional and their recitation in the claims amounts to “significantly more” than the abstract idea. The Federal Circuit said that the markings on Appellant’s dice constituted printed matter, as pointed out by the Board, and this court has generally found printed matter to fall outside the scope of §101.

Specifically, the Federal Circuit said that each die’s marking or lack of marking communicates information to participants indicating whether the
player has won or lost a wager, similar to the markings on a typical die or a deck of cards. Accordingly, the recited claim limitations are directed to information. Additionally, the Federal Circuit observed that the printed indicia on each die are not functionally related to the substrate of the dice.

The Federal Circuit also rejected rejected applicant’s argument that the claimed method of playing a dice game cannot be an abstract idea because it recites a physical game with physical steps. The Federal Circuit said that the abstract idea exception does not turn solely on whether the claimed invention comprises physical versus mental steps.

The Federal Circuit concluded that because the only arguably unconventional aspect of the recited method of playing a dice game is printed matter, which falls outside the scope of § 101, the rejected
claims did not recite an “inventive concept” sufficient to “transform” the claimed subject matter into a patent eligible application of the abstract idea.

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Primers and the Use of Naturally Occurring Position-Specific Signature Nucleotides are Patent Ineligible

In Roche Molecular Systems, Inc., v. Cepheid, [2017-1690] (October 9, 2018), the Federal Circuit affirmed summary judgment of invalidity of claims of U.S. Patent No. 5,643,723 as directed to patent ineligible subject matter.

The ’723 patent is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis.  The ’723 patent provides two types of claims: (1) composition-of-matter claims for the primers used in the PCR, which could hybridize to the rpoB gene of MTB at a site that includes at least one of the eleven signature nucleotides (“the primer claims”); and (2) process claims for methods for detecting MTB that include amplifying target sequences by PCR and detecting amplification products,
which, if present, indicate the presence of MTB (“the method claims”).

As to the primer claims, the Federal Circuit held that In re BRCA1 foreclosed Roche’s arguments for patentability. There, the Federal Circuit examined the subject matter eligibility of similar primer claims and held that those primers were not distinguishable
from the isolated DNA found patentineligible in Myriad” and thus are not patent-eligible.  Primers necessarily contain the identical sequence of the nucleotide sequence directly opposite to the DNA strand to which they are designed to bind.  The subject matter eligibility inquiry of primer claims hinges on comparing a claimed primer to its corresponding DNA segment on the chromosome—not the whole chromosome.

As to the method claims, the Federal Circuit said that the claims disclose a diagnostic test based on the observation that the presence of the eleven position-specific signature nucleotides of the naturally occurring MTB rpoB gene indicates the presence
of MTB in a biological sample.  The method claims are directed to a relationship between the eleven naturally occurring position-specific signature nucleotides and the
presence of MTB in a sample. In other words, the method claims assert that if an investigator detects a signature nucleotide from a sample, she knows the sample contains MTB. This relationship between the signature nucleotides and MTB is a phenomenon that exists in nature apart from any human action, meaning the method claims are directed to a natural phenomenon, which itself is ineligible for patenting.

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Details Save Claims from Invalidity Under Section 101

In Data Engine Technologies LLC v. Google LLC, [2017-1135] (October 9, 2018), the Federal Circuit affirmed in part, reversed in part, and remanded, entry of judgment on the pleadings holding that the asserted claims of DET’s U.S. Patent Nos. 5,590,259; 5,784,545; 6,282,551; and 5,303,146 are ineligible under 35 U.S.C. § 101.

The Federal Circuit concluded that with the exception of claim 1 of the ’551 patent, the asserted claims of the ’259, ’545, and ’551 patents are directed to patent-eligible subject matter, finding that these claims claims are not abstract, but rather are directed to a
specific improved method for navigating through complex three-dimensional electronic spreadsheets. The Federal Circuit agreed that the asserted claims of the ’146 patent,
reciting methods for tracking changes to data in spreadsheets, were directed to the abstract idea of collecting, recognizing, and storing changed information.

Regarding the ’259, ’545, and ’551 patents, the Federal Circuit said that the claimed method does not recite the idea of navigating through spreadsheet pages using buttons or a generic method of labeling and organizing spreadsheets. Rather, the claims require a specific interface and implementation for navigating complex three-dimensional spreadsheets using techniques unique to computers.


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Doing New and Useful Things Still Isn’t Enough to Meet 35 USC §101

In BSG Tech LLC v. Buyseasons, Inc., [2017-1980](August 15, 2018), the Federal Circuit affirmed the dismissal of an action for infringement of U.S. Patent Nos. 6,035,294, 6,243,699, and 6,195,652, directed to a “self-evolving generic index” for organizing information stored in a database, as being directed to ineligible under 35 USC §101.

The Federal Circuit agreed with the district court that the asserted claims were directed to the abstract idea of considering historical usage information while inputting data.  The claims’ “focus” is guiding database users by presenting summary comparison information to users before they input data.  This is not a method “necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of” wide access databases.  It amounts to having users consider previous item descriptions before they describe items to achieve more consistent item descriptions. Whether labeled as a fundamental, long-prevalent practice or a well-established method of organizing activity, this qualifies as an abstract idea.

The Federal Circuit rejected BSG’s arguments for patentability.  First, BSG Tech argued that the claims require a specific database structure, but claims are not saved from abstraction merely because they recite components more specific than a generic computer.  Second, BSG Tech argued that the claims are not directed to an abstract idea because they require users to specifically consider “summary comparison usage
information” rather than any type of historical usage information, but this was not persuasive, because of the broad meaning of “summary comparison.”  Third, BSG Tech insists that its claims focus on a non-abstract improvement in database functionality.  Ultimately the Federal Circuit found that these benefits, however, are not improvements to database functionality.

Having determined that the claims are directed to an abstract idea, the Federal Circuit proceeded on to step 2 of the Alice analysis, where it found that the only alleged unconventional feature of the claims is the requirement that users are guided by
summary comparison usage information or relative historical usage information — which simply restates what had already been determined was an abstract idea.

The Federal Circuit affirmed the district court’s grant of summary judgment that all asserted claims on appeal are ineligible under § 101.

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Federal Circuit Revises Opinion, But Still Holds Subject Matter Unpatentable

IN SAP AMERICA, INC., v. INVESTPIC, LLC, [2017-2081] (August 2, 2018), the Federal Circuit revised its May 15, 2015, Opinion, as a result of InvestPic’s Motion for Rehearing.  The Federal Circuit still affirmed judgment on the pleadings that all of the claims of U.S. Patent No. 6,349,291, on systems and methods for performing certain
statistical analyses of investment information, but provided additional coverage of the Reexamination claims.


Posted in 101

Displaying Data is an Even More Abstract Idea Than Patent Eligibility

In Interval Licensing LLC v. AOL, Inc., [2016-2502, 2016-2505, 2016-2506, 2016-2507] (July 20, 2018), the Federal Circuit affirmed the district court’s determination that claims 15-18 were directed to an abstract idea: the presentation of two sets of information, in a nonoverlapping way, on a display screen.

The Federal CIrcuit said that considered as a whole, the claims fail under § 101’s abstract idea exception because they lack any arguable
technical advance over conventional computer and network technology for performing the recited functions of acquiring and displaying information.  The Federal Circuit pointed out that the specification describes the claimed instructions as routine and conventional.

In this case, Interval Licensing contends that the claimed “attention manager” provides a technological improvement to a computer system. The Federal Circuit disagreed, noting that the focus of the claims here is directed to “providing information to a person without interfering with the person’s primary activity,” i.e., the result-centric construction of the claimed “attention manager.”  The Federal Circuit said that standing alone, the act of providing someone an additional set of information without disrupting the ongoing provision of an initial set of information is
an abstract idea, noting the use of a breaking news ticker across the bottom of the screen.  The Federal Circuit said that it has held that information is intangible, and that collecting, analyzing, and
displaying that information, without more, is likewise an abstract idea.  The Federal Circuit said that recitation, as in this case, of the collection, organization, and display of two sets of information on a generic
display device is abstract absent a “specific improvement to the way computers or other technologies operate, remained abstract.

The Federal Circuit also rejected the argument that the claims are not abstract in view of the claimed display instructions, pointing out that the the claimed instructions do not identify how the function is performed.  The Federal Circuit said that acquiring and organizing information, as broadly recited by some of the instructions
limitations, is an abstract idea, not an improvement in how computers and networks carry out their basic functions.

The Federal Circuit also rejected the argument that acquisition of specific information desired by the user represented an inventive concept, noting that offering a user the ability to select information to be displayed is one of the “most basic functions of a computer.”

Having have considered all of Interval Licensing’s arguments and finding them unpersuasive, the Federal Circuit affirmed the determination that 15–18 of the ’652 patent were directed to patent ineligible subject matter.

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