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An Illustrated Guide to the USPTO’s New Memo on Method of Treatment Claims

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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;

and

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.

Source: https://www.bioloquitur.com/illustrated-guide-usptos-new-memo-method-treatment-claims/

Blockchain

Europe Now World’s Biggest Crypto Economy: Boasts Over $1T Worth of Transactions

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Central, Northern, and Western Europe (CNWE) has grown into the world’s largest cryptocurrency economy since July 2020. The region experienced a massive increase in trading activity since then– particularly in the DeFi space.

The European DeFi Boom

Data from Chainalysis shows that CNWE received over $1 trillion in cryptocurrency over the last year alone. This represents 25% of global trading activity. Furthermore, it is responsible for at least 25% of all crypto value received by other regions, including 34% of the value received in North America.

This makes the EU the most concentrated in the world in terms of cryptocurrency trading volume. This is partially due to increases in all forms of trading activity over the past year, coming mostly from institutional investors.

Large institutional transaction value grew from $1.4B in July 2020 to $46.3B in June 2021, coming to take up half of all CNWE trading activity. The most pronounced increases were seen on DeFi protocols, where over 80% of these large institutional transactions were sent in June.

The impact of DeFi is further established when ranking coins in terms of transaction activity in the region. Despite being the largest cryptocurrency by market cap, Bitcoin heavily trails Ethereum in transaction volume among large institutional investors. Additionally, DeFi protocols took up a majority share of funds received by cryptocurrency services in CNWE in June 2021.


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The Decline in Eastern Asia

CNWE has seen significant absolute increases in its crypto trading volume. However, its new place as the world’s largest trading hub is partly due to a sharp decline in market share held by Eastern Asia– the previous world leader.

In early 2019 the region held over 30% of global transaction volume. This figure has since fallen sharply to about 15% – less than CNWE, North America, and even Central and Southern Asia.

This may be related to China’s continued push to prevent and discourage crypto trading within its borders. China re-announced their ban on crypto trading in the country days ago, and have been moving to prevent all access to exchanges within the country.

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Source: https://cryptopotato.com/europe-now-worlds-biggest-crypto-economy-boasts-over-1t-worth-of-transactions/

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Here’s why a multi-CBDC bridge is being tested on Ethereum

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The race to launch the first CBDC is one the world is following intently. While most have their eyes fixed on China’s digital yuan pilot, a group of countries has come together to take CBDCs a step further.

Phase 3 of Project Inthanon-LionRock saw BIS Innovation Hub Hong Kong Centre, the Digital Currency Institute of the People’s Bank of China, and the Central Bank of the United Arab Emirates experiment with a multi-CBDC bridge or an mBridge.

What does this mean?

The mBridge initiative would ideally allow central banks in different countries to issue and redeem their own CBDCs across borders on a common platform – without having to depend on correspondent banks.

Meanwhile, commercial banks would be able to “submit peer-to-peer CBDC push payments.”

The BIS September 2021 report stated,

“If successful, an efficient, low cost, compliant and scalable multi-currency, multi-jurisdiction arrangement can provide a network of direct central bank collaboration, greatly increasing the potential for international trade flows and cross-border business at large.”

The report further clarified,

“The prototype demonstrates a substantial improvement in cross-border transfer speed from multiple days to seconds, as well as the potential to reduce several of the core cost components of correspondent banking.”

Here, it is also interesting to note that the project’s Phase 2 prototype was built on Ethereum. This was because the core layer of the prototype contained the blockchain ledger and smart contracts.

Notes on features

As a multiple CBDC project, regulation and compliance were functional requirements. Central banks would be able to monitor transactions in real-time, set balance limits, control the balance held by their commercial banks, and use data for surveillance.

Scalability was also part of the design to later onboard more participants and jurisdictions.

However, one complication was the wide difference in remittance charges across countries. While the global average was calculated to be 6.38% of the remitted sum, the report observed that even a percentage as low as 1% would be costly for payments in the millions of dollars.

An update from China

Alongside the mBridge project, China has also been steamrolling ahead with its CBDC program.

Changchun Mu, Director-General of the DCI of the People’s Bank of China. confirmed that e-CNY pilots have been taking place in 10 areas.

Mu added,

“Payment methods such as QR code and tap-and- go have been well-supported and innovative services such as dual-offline payment and wearable device payment have been tested for safety and efficiency.”

Meanwhile, Howard Lee, Deputy Chief Executive of the Hong Kong Monetary Authority, suggested that an e-HKD could also be in the works.

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Source: https://ambcrypto.com/heres-why-a-multi-cbdc-bridge-is-being-tested-on-ethereum

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Blockchain

This is the safest strategy for Dogecoin traders

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Disclaimer: The findings of the following analysis are the sole opinions of the writer and should not be taken as investment advice

Very few buy opportunities have been presented in the Dogecoin market. Trading at a 73% discount from its May all-time high, DOGE has been picked apart by short-sellers who have capitalized on weakening metrics on all fronts.

Over the next week, the major support line of $0.160 would be under tremendous pressure to fuel a rally. If sellers continue their relentless assault, another 50% plummet to February levels would be possible.

At the time of writing, DOGE was trading at $0.201, down by 3.4% over the last 24 hours.

Dogecoin Daily Chart

Source: DOGE/USD, TradingView

Dogecoin’s daily chart offered a buffet of bearish signals. Firstly, the candles traded below their daily 20, 50, and 200 Simple Moving Average lines. Not only do such readings attract short-selling, but also dissuade buyers from taking up long positions.

Secondly, a death cross was just around the corner, one which exposed the market to another major sell-off. Moreover, retail traders have sought different options rather than testing their luck with Dogecoin. Data from Santiment highlighted that its trading volume has remained in the $1-$2 billion range lately, as opposed to the $5-$7 billion range seen during rallies.

Now, keeping these factors aside, the Visible Profile suggested that DOGE was still trading within its developing value range of $0.455 and $0.17. As long as DOGE maintains above the lower end of this range, a complete blowout can be avoided.

A minor rally seemed possible as investors mop up DOGE at the $0.16-support. However, a close below $0.16 would open the floodgates for an extended fall. The next immediate support lay at $0.087. This meant that DOGE would decline by another 43% before buyers can respond.

Reasoning

Of late, Dogecoin has been trending lower after a descending triangle breakdown. A throwback to $0.232 can be expected to transpire into further losses towards $0.16. Naturally, DOGE’s indicators flashed alarm bells. The RSI was close to the overbought zone and suggested some more weakness before a reversal.

The Awesome Oscillator and MACD also maintained movement below their respective half-lines due to market weakness.

Conclusion 

Apart from a few scalping opportunities, short-selling seemed to be the most viable trading strategy in the Dogecoin market.

Although shorting at DOGE’s press time level would not be a bad call, a safer bet can be placed once DOGE closes below $0.16-$0.17.

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Source: https://ambcrypto.com/this-is-the-safest-strategy-for-dogecoin-traders

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