The U.S. Patent and Trademark Office (“USPTO”) has renewed the hopes of applicants looking to patent method of treatment claims. A recent memo from the USPTO (the “Memo”) provides guidance on method of treatment claims, suggesting that when correctly drafted, such claims should generally be considered patent eligible subject matter.
The Memo comes in direct response to the Federal Circuit’s decision in Vanda v. West-Ward, issued on April 13, 2018. In Vanda, the Court, inter alia, distinguished certain method of treatment claims as patent eligible from those deemed ineligible by the Supreme Court in the infamous Mayo decision in 2012. The Court in Vanda found that the method of treatment claims at issue passed the first prong of the Mayo test, i.e., they were not directed to patent ineligible subject matter, and thus the claims did not need to be analyzed for an inventive concept under the second prong. To support its decision, the Vanda panel highlighted the specificity of the claims at issue:
At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. They are different from Mayo. They recite more than the natural relationship between CYP2D6 metabolizer genotype and the risk of QTc prolongation. Instead, they recite a method of treating patients based on this relationship that makes iloperidone safer by lowering the risk of QTc prolongation. Accordingly, the claims are patent eligible.
For the reader’s convenience, an illustration from the USPTO on the Mayo test is reproduced to the left and a side-by-side comparison of the claim terms in Vanda and Mayo is set forth in the table below.
In analyzing the Vanda decision, the memo highlights three points:
- First, claims should be evaluated as a whole. Thus, a claim should not be deemed patent ineligible simply because a claim requires a conventional step.
- Second, patent eligible claims apply a natural relationship rather than claim such a relationship. For example, the claims in Mayo were deemed to be “directed to” the natural relationships of how the body interacts with certain drugs – “[a] method of optimizing therapeutic efficacy” – while the claims in Vanda apply a natural relationship through specific actions to treat a specific disease – “[a] method for treating a patient with iloperidone, [for treating] schizophrenia” and lowering adverse risks of such treatment.
- Third, if a method of treatment claim is patent eligible under the first prong, of the Mayo test, the Court should not further proceed to the second prong of the Mayo test, i.e., analyzing the claims for something “more,” also known as the illusive “inventive concept.”.
With respect to the second point above, the Memo further explained that correctly drafted claims claim the application of a natural relationship rather than being directed to The Memo highlighted the order of the “primary steps” of “determining” the natural relationship then “administering” a specific quantity to “treat a particular disease.” A rule of thumb thus could be whether the following can be stated after reading a method of treatment claim: “The claim is directed to a method of using _______ [drug] to treat _______ [condition] comprising the following steps . . .”
The claims in Mayo, however, administered a drug and then analyzed the body’s natural reaction in order to provide advice on whether to increase or decrease dosage. In contrast, the claims in Vanda first determined the body’s natural reaction to a drug, then administered the drug in a specific dosage range to treat a particular disease.
While the Memo and the Vanda case signal good news for patentees, there is still a chance, as there always is with the Federal Circuit and the Supreme Court, that future decision may change these interpretations yet again. The Vanda decision was not unanimous. Chief Judge Prost of the Federal Circuit dissenting in Vanda believes that the claims were merely “drafting efforts designed to monopolize the law of nature itself.” According to Chief Judge Prost, “[t]he fact that a reduction of iloperidone dosage in poor metabolizers to the [sic] may reduce QTc prolongation is both the means and the ends of this claim..” A petition for rehearing en banc is currently pending before the Federal Circuit; a Supreme Court petition will likely follow.
Mayo: US Patent 6,355,623
Vanda: US Patent 8,586,610
|1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
|1. A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient;
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.
DeFi surge, rising TVL and new partnerships underpin Ren’s 100% rally
Interoperability between blockchains is rapidly becoming one of the buzz phrases being thrown around when discussing decentralized finance and the coins most likely to rally during an altcoin bull run.
The rapid growth of DeFi, its ever expanding total value locked and soaring ETH gas fees further highlight the sector’s need for a layer 2 option that also supports the ability to transact value across different networks.
REN’s open protocol is designed specifically to fill this need by providing interoperability and liquidity between the top blockchains including Bitcoin, Ethereum and Zcash.
Over the past three weeks the price of REN has increased by more than 200%, going from $0.251 on Dec. 27 to a new all-time high of $0.778 on Jan. 20 driven by a record $369 million in 24-hour volume.
Three reasons for the recent price surge in the price of REN include the announcement of a collaboration with Google, the continued increase in total value locked on the platform and the ability to earn passive income in multiple cryptocurrencies through the operation of a darknode.
Google software pivot boosts sentiment, addresses RENvm scaling issues
On Jan.19 the REN team tweeted:
Ren has been researching & building on @Asylodev, an open and flexible framework by @Google. @GCPCloud confidential computing relaxes RenVM’s economic constraints, allowing for an unbounded scaling solution. #RenVM.”
Not long after the tweet, REN price began to rally to a new all-time high. As mentioned in the tweet, Asylo is an open and flexible framework from Google designed to help build portable applications that run on Secure Enclave hardware.
The secure enclave hardware allows users to run general-purpose applications in a secure environment where both the data, and the application itself, cannot be compromised by anyone, including the user. This makes for a more secure experience for all parties involved and helps protect against malicious code and backdoor attacks.
Asylo also makes it possible to port an application from one type of hardware to the next, meaning that developers can support multiple implementations with relative ease, including Intel implementations, AMD implementations, and any others that appear in the future. The diversity of choice this allows is an important feature to ensure decentralization on the network.
Total value locked soars to a new high
Community engagement and added value are key factors when it comes to the long-term success of a blockchain project.
Since the release of the Ren virtual machine mainnet (RenVM) in May 2020, engagement on the platform has steadily increased as Bitcoin holders now had another way to bring their BTC to Ethereum and the growing DeFi space.
As seen in the chart below, the total value locked on the Ren platform reached a new all-time high of $653.6 million on Jan. 20 and a total of 14,670 BTC are locked on the platform to create renBTC.
The list of assets that RenVM supports continues to grow with BTC, Bitcoin Cash (BCH), Zcash (ZEC), Filecoin (FIL), Terra (LUNA), Dogecoin (DOGE) and Digibyte (DGB) currently available to transact on the Ethereum and Binance blockchains.
Development is currently underway to make it possible to interact on the Polkadot (DOT), Solana (SOL) and Cosmos (ATOM) networks as well, which would further enhance the interoperability provided.
Darknodes, passive income and a decreasing supply
The third driving force behind the recent price appreciation of REN relates to the Ren token use case and how it can help users earn passive income. RenVM is a network of virtual computers that make up a virtual machine, which are also referred to as Darknodes.
REN token holders who wish to operate a darknode need to lock up 100,000 REN which wiil enable them to process transactions on the network and earn a fee in the form of the token transacted. Thus, a darknode operator has the opportunity to earn passive income in the form of multiple different cryptocurrencies from one location.
As can be seen in the above graphic, 17.13% of REN’s total supply is currently bonded on the platform and supports the operation of darknodes.
During the most recently completed cycle, the network as a whole earned $839,128 in fees in the form of BTC, ZEC, FIL and BCH. The total network fees collected since the launch of the RenVM equals $2.975 million.
The continued addition of new tokens and interoperability with new blockchains will likely see increased usage of the network and an increase in the amount of fees earned. At the current price of $0.6157 it costs $61,570 to operate a darknode.
As activity on the network increases, the amount of fees generated will also increase, making it even more lucrative for token holders to operate a darknode. This has the potential to lead to further price appreciation from REN as every new darknode results in a direct decrease in its circulating supply.
The views and opinions expressed here are solely those of the author and do not necessarily reflect the views of Cointelegraph.com. Every investment and trading move involves risk, you should conduct your own research when making a decision.
Denarius Announces Beta of Kronos Wallet and Private Decentralized Chat
Kronos, a new application beta from the developers of Denarius (D), provides people a way to socialize and transact without a central authority. This new proof of concept takes decentralization, blockchain and privacy to the next level.
“Blockchains like Bitcoin and Ethereum have paved the way of innovation for cryptocurrencies and new applications like Denarius (D): Kronos, to bridge the gap for a faster and cheaper way to transact and utilize cryptocurrency.” — James R. (Cryptocurrency User)
Kronos, a new application beta from the developers of Denarius (D), provides people a way to socialize and transact without a central authority. This new proof of concept takes decentralization, blockchain, and privacy to the next level. “Users” are able to freely join the Kronos Chat platform, as it is redundantly available due to it using peer-to-peer technology. Kronos has no downtime or possible banning of the platform. Examples of this in current history include, Amazon Web Services (AWS) taking down the Parler app’s platform hosting . Google Play Store and Apple App Store removing the Parler application . Signal App going offline . Whatsapp invasion of privacy …the list goes on.
Kronos is a secure cryptocurrency wallet but also chat reinvented. With the Kronos Chat you can chat and send cryptocurrency across the world in seconds. End-to-end encrypted messages and no storage of your chats, anywhere. Kronos Chat is powered by YOU by leveraging the latest peer-to-peer technologies. Censorship is everywhere and increasing daily. Kronos Wallet allows you to be truly free, with “self-moderation” you finally have the power to choose your own censorship while you socialize. Kronos stores only required data securely and locally, not on an unknown centralized server in the cloud. Kronos supports optional Two Factor Authentication (2FA) and One-time Password (OTP) Yubikey authentication and uses BIP39 technology for your cryptocurrency wallet with the most advanced and leading encryption technologies available today.
Bitcoin was the first cryptocurrency to solve the Byzantine Generals Problem, but transactions are slow. Ethereum created a smart contract platform, but transaction fees are expensive. Denarius stayed true to its roots by forking the original Bitcoin Satoshi code and modified the coin to become a faster and cheaper alternative to Bitcoin. Now Denarius with Kronos changes things. BTC, ETH, and D coins can be sent using the Kronos Wallet with more cryptocurrencies and tokens being added soon, possibly USDC, USDT, Namecoin (NMC), Devault (DVT), Primecoin (XPM), etc. Interplanetary File System (IPFS) integration and file uploading directly inside of the Kronos Chat also allows the user to upload files such as documents, images, and media directly inside of Kronos, ready to be shared via the plethora of IPFS public gateways available.
Bitcoin (BTC) created by Satoshi Nakamoto
Ethereum (ETH) created by Vitalik Buterin
Denarius (D) created by Carsen Klock
Bitcoin (BTC): https://bitcoin.org
Ethereum (ETH): https://ethereum.org
Wen? Now! BadgerDAO’s synthetic rebasing Bitcoin, DIGG, goes live
After weeks of anticipation and a closely-watched series of preparatory steps, BadgerDAO’s synthetic rebasing Bitcoin, DIGG, is now live and claimable for qualified addresses on Ethereum mainnet.
The release will be eagerly welcomed by a perhaps-overzealous community, one which has been lighting up Twitter with “wen DIGG” for weeks. For all the memes and excitement, however, there’s some serious technical heft behind both the distribution and the maintenance of the newest Bitcoin asset on Ethereum.
Ultimately, however, now that DIGG is in the wild market forces are what will determine the long-term success of the synthetic Bitcoin asset — success that might not be assured.
Fair, flat launch
According to core BadgerDAO contributor and distribution architect Jon Tompkins, the amount of claimable DIGG for each eligible account was determined using a formula centered on an Ethereum address’ activity in the BadgerDAO app. Factors such as total native platform Badger tokens earned, the Badger earned to Badger staked ratio, and total stake days were taken into consideration.
In order to prevent an overallocation to deep-pocketed “whales,” however, the DAO approved an application of a 1.75 root to smooth the distribution between addresses. As Tompkins wrote in the original DIGG distribution proposal, this root means that, while in a linear distribution the top 100 addresses would have been eligible to receive over 70% of DIGG, they instead will be able to claim just 33%.
Tompkins said that of the 600 DIGG tokens currently available the top address will receive 8.75 DIGG, while the average of the 8517 eligible addresses will be able to claim .07 of a token.
The goal of this distribution was to allow the project to “reward the little guys that are strong badger supporters but not fully disadvantage the whales,” said Tompkins.
Keeping a peg
Now that the token is live, the rebase games begin.
Algorithmic stablecoins have been a hot topic in DeFi circles over the past few months as one of the most popular trading vehicles. The assets, which are primarily meant to track the price of the US dollar, have “rebasing” features that dynamically expand or contract the total supply of the asset based on preset parameters such as price or time.
So far, however, they’ve proven to be far more effective at enriching users who know how to play the rebase parameters than they’ve been at creating truly stable assets.
DIGG will be possibly the first-ever synthetic rebasing Bitcoin, and certainly the first to feature this distribution method. Out of the gate users will be able to stake their DIGG in a yield-bearing vault, use it to provide liquidity to DIGG/WBTC Sushiswap and Uniswap pairs, hold the core asset in anticipation of a positive rebase, or sell the tokens on the open market.
While there has been speculation as to how DIGG will perform and what the best strategies might be, it’s ultimately unclear to what degree the asset will be able to hew to its intended peg given BTC’s volatility and DIGG’s unique launch.
In a previous interview with Cointelegraph, BadgerDAO founder Chris Spadafora expressed hope that additional forthcoming stabilization mechanisms will be able to help DIGG better track BTC, however.
“What we want to do with our vault system is really at large-scale be the… let’s call it the ‘buy-and-sell’ dictators. So through automated strategies we’re able to buy when the time is right and sell when the time is right to optimize return for the users,” he said.
Forthcoming vaults designed to programmatically play the rebase games are designed to do just that, but given the uncharted game-theoretical landscape it’s impossible to say if the vaults will be sufficient to stabilize DIGG — or what happens after vault incentives dry up.
In the end, after weeks of anticipation, instead of “Wen DIGG?” BadgerDAO participants lining up to take a spin at the latest rebase casino now must ask themselves, “What’s next?”
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