IP Verse

Therapeutic Agents For Neurodegenerative Diseases

Patent No. US12144792 (titled "Therapeutic Agents For Neurodegenerative Diseases") was filed by Intrabio Ltd on Aug 11, 2017.

What is this patent about?

’792 is related to the field of treating neurodegenerative diseases . These diseases, which include conditions like Alzheimer's, ALS, and Parkinson's, involve the progressive loss of neuronal structure and function, leading to physical and mental decline. Current treatments are limited, and there is a need for more effective and widely applicable therapies.

The underlying idea behind ’792 is that administering acetyl-leucine , or a pharmaceutically acceptable salt thereof, can treat neurodegenerative diseases. This involves providing a therapeutically effective amount of the compound to a subject in need thereof for an extended period. The insight is that acetyl-leucine acts as a neuroprotective agent, inhibiting the neurodegeneration process itself and improving cellular function, particularly in relation to lysosomal dysfunction.

The claims of ’792 focus on methods of treating neurodegenerative diseases, excluding cerebellar ataxia and Niemann-Pick Type C, by administering acetyl-leucine. Specifically, the independent claims cover administering a therapeutically effective amount of acetyl-leucine for a duration of at least three months to provide neuroprotection , delay disease progression, reverse disease progression, or reduce the severity of the disease. The target diseases include Alzheimer's, ALS, MSA-P/C, frontotemporal dementia with parkinsonism, progressive supranuclear palsy, corticobasal degeneration, Lewy Body dementia, Parkinson's Disease, and ataxia telangiectasia.

In practice, the invention involves identifying a subject with a neurodegenerative disease and administering acetyl-leucine orally, typically in multiple doses per day to achieve a total daily dose between 500 mg and 15 g. The treatment continues for months or years, with the goal of slowing or reversing the disease's progression. The effectiveness is monitored using clinical assessments like the Scale for Assessment and Rating of Ataxia (SARA) or the Unified Parkinson's Rating Scale (UPRS), as well as biochemical markers.

The differentiation from prior approaches lies in the unexpected discovery that acetyl-leucine, previously known for treating vertigo, can provide long-term neuroprotection and disease modification in neurodegenerative conditions. While prior art showed symptomatic improvement of ataxia using acetyl-DL-leucine, it was not known to treat neurodegenerative diseases, which generally progress over years to decades. The patent demonstrates that acetyl-leucine can delay onset, reduce severity, delay progression, or even reverse the progression of these debilitating diseases, offering a new therapeutic avenue.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’792 was filed, at a time when therapeutic interventions for neurodegenerative diseases were typically focused on symptomatic relief and management of disease progression, rather than curative treatments. Systems commonly relied on established methods for drug delivery and patient monitoring, and hardware or software constraints made long-term, personalized treatment regimens non-trivial.

Novelty and Inventive Step

The examiner approved the application because the claimed method of treating neurodegenerative diseases with acetyl-leucine for at least 3 months, excluding cerebellar ataxia or Niemann-Pick Type C, and specifying a twice-daily dosage of 500mg to 15g, was considered novel and non-obvious. The examiner stated that the closest prior art, Bremova, teaches acetyl-leucine for cerebellar symptoms in Niemann-Pick type C patients, but does not teach the patient population as claimed in the instant invention or the claimed therapeutic regimen. The examiner also noted that the applicant successfully demonstrated the effectiveness of the invention with examples. Additionally, the examiner stated that the applicant's filing of terminal disclaimers over related applications overcame obviousness-type double patenting rejections.

Claims

This patent contains 18 claims, of which claims 1, 7, 8, 9, 16, and 17 are independent. The independent claims generally focus on methods of treating, delaying progression, reversing progression, reducing the severity of, or providing neuroprotection for neurodegenerative diseases using acetyl-leucine. The dependent claims generally specify details and limitations to the methods described in the independent claims, such as the type of neurodegenerative disease, duration of treatment, dosage, and form of acetyl-leucine.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Acetyl-leucine
(Claim 1, Claim 7, Claim 8, Claim 9, Claim 16, Claim 17)		“In particular, the present disclosure describes acetyl-leucine for treating a neurodegenerative disease or one or more symptoms of a neurodegenerative disease in a subject. In one embodiment, there is disclosed acetyl-leucine, or a pharmaceutically acceptable salt thereof, for use in a method of treating a neurodegenerative disease or one or more symptoms associated with a neurodegenerative disease in a subject in need thereof, wherein the neurodegenerative disease is not cerebellar ataxia or Niemann-Pick type C disease.”A compound used to treat neurodegenerative diseases or their symptoms.
Delaying progression
(Claim 8)		“In another embodiment, there is disclosed acetyl-leucine, or a pharmaceutically acceptable salt thereof, for use in a method of delaying onset of a neurodegenerative disease or one or more symptoms of a neurodegenerative disease that would otherwise be expected to manifest according to typical disease progression. In one embodiment, the present disclosure describes acetyl-leucine, or a pharmaceutically acceptable salt thereof, for use in a method of delaying progression of a neurodegenerative disease or one or more symptoms associated with a neurodegenerative disease over time as compared to typical disease progression, wherein the method comprises administering a therapeutically effective amount of the acetyl-leucine to the subject in need thereof for a duration chosen from at least about 3 months, at least about 6 months, at least about 1 year, at least about 2 years, and at least about 5 years.”Slowing down the advancement of a neurodegenerative disease or its symptoms over time compared to typical disease progression.
Neurodegenerative disease
(Claim 1, Claim 7, Claim 8, Claim 9, Claim 16, Claim 17)		“Neurodegenerative diseases are those that affect neurons. The degenerative process can involve the progressive loss of neuronal structure, the progressive loss of neuronal function, or progressive neuron cell death. Such progressive neurodegeneration often results in physical disability and mental deterioration.”A disease affecting neurons, involving progressive loss of neuronal structure or function, or neuron cell death.
Providing neuroprotection
(Claim 17)		“In a further embodiment, the present disclosure includes acetyl-leucine, or a pharmaceutically acceptable salt thereof, for use in a method of providing neuroprotection in a subject having, suspected of having, or at risk of having a neurodegenerative disease, wherein the method comprises administering a therapeutically effective amount of the acetyl-leucine to the subject for a duration chosen from at least about 3 months, at least about 6 months, at least about 1 year, at least about 2 years, and at least about 5 years.”Protecting neurons in a subject having, suspected of having, or at risk of having a neurodegenerative disease.
Therapeutically effective amount
(Claim 1, Claim 7, Claim 8, Claim 9, Claim 16, Claim 17)		“In a further embodiment, the present disclosure includes acetyl-leucine, or a pharmaceutically acceptable salt thereof, for use in a method of treating a neurodegenerative disease or one or more symptoms associated with a neurodegenerative disease in a subject in need thereof, wherein the method comprises administering a therapeutically effective amount of the acetyl-leucine to the subject in need thereof for a duration chosen from at least about 3 months, at least about 6 months, at least about 1 year, at least about 2 years, and at least about 5 years.”An amount of acetyl-leucine sufficient to treat, delay, reverse, or reduce the severity of a neurodegenerative disease or its symptoms, or to provide neuroprotection.

Patent Family

Patent Family

File Wrapper

The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents

US12144792

INTRABIO LTD
Application Number
US16324353
Filing Date
Aug 11, 2017
Status
Granted
Expiry Date
Aug 11, 2037
External Links
Slate, USPTO, Google Patents