# US 12,109,246 B2 · Composition for the treatment and/or prevention of lower urinary tract symptoms

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,109,246 B2
- Document ID: US12109246B2
- Status: Granted
- Kind: B2
- Application number: 17/365,055
- Filed: 2020-01-13
- Published: 2023-05-18
- Granted: 2024-10-08
- Earliest claimed: 2019-01-18
- Assignees: Serelys Pharma S.A.M.
- Applicants: Serelys Pharma S.A.M.
- Inventors: Sossio Morra
- Web page: https://patentgrep.com/patent/US12109246B2

## CPC

- A61K 36/899: Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 36/15: Pinaceae (Pine family), e.g. pine or cedar
- A61K 36/42: Cucurbitaceae (Cucumber family)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 13/00: Drugs for disorders of the urinary system
- A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers
- A61P 13/10: of the bladder
- A61K 2236/331: using water, e.g. cold water, infusion, tea, steam distillation or decoction
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Compositions for treatment and/or prevention of lower urinary tract symptoms (LUTS). include a pollen extract containing an aqueous pollen extract obtained from a plant mixture belonging to the Poaceae and Pionaceae families, an aqueous extract of plant seeds belonging to the genus Cucurbita and of vitamin E or its esters. Methods for treatment and/or prevention of lower urinary tract symptoms (LUTS) associated with the filling, urination and/or post-urination phases in women with such compositions is disclosed.

## Claims

### Claim 1

A composition comprising:
a pollen extract consisting of an aqueous pollen extract obtained from a plant mixture belonging to the family Pinaceae and Poaceae, wherein the aqueous pollen extract is obtained from a mixture of:
45% to 90% aqueous extract of pollen of Secale cereale L. by weight of the total weight of the extract;
1% to 35% aqueous extract of pollen of Zea mays L. by weight of the total weight of the extract;
0.01% to 5% aqueous extract of pollen of Pinus sylvestris L. by weight of the total weight of the extract;
3% to 30% aqueous extract of pollen of Dactylis glomerata L. by weight of the total weight of the extract,
an aqueous extract of plant seeds belonging to the genus Cucurbita containing fatty acids at a content of less than 10% by weight of the total weight of the extract, vitamin E or its esters; and
an aqueous extract of the pistil of Zea mays L.,
wherein the composition treats lower urinary tract symptoms (LUTS) associated with the filling, micturition and/or post-micturition phases in women and, wherein the lower urinary tract symptoms (LUTS) associated with the filling, micturition and/or post-micturition phases in women is urinary incontinence.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the aqueous extract of Cucurbita seeds contains fatty acids at a content of between 5 and 8% by weight of the total weight of the extract.

### Claim 3 (depends on 1)

The composition of claim 1, further comprising an active agent selected from the group consisting of manganese, and extracts of Betula alba, Cerasus avium, Equisetum arvense, Phaseolus vulgaris, Achillea millefolium, Agropyron repens, Galium verum, Lavandula officinalis, Mentha piperita, or Urticaria dioica.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the composition is in a form suitable for oral administration.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the form suitable for oral administration is selected from the group consisting of a tablet, a capsule, a soft capsule, a soft gel, a semi-solid, a solid, a liquid, and a powder.

### Claim 6

A method for treatment of lower urinary tract symptoms (LUTS) associated with the filling, micturition and/or post-micturition phases in women, the method comprising:
providing an oral composition comprising:
a pollen extract consisting of an aqueous pollen extract obtained from a plant mixture belonging to the family Pinaceae and Poaceae, wherein the aqueous pollen extract is obtained from a mixture of:
45% to 90% aqueous extract of pollen of Secale cereale L. by weight of the total weight of the extract;
1% to 35% aqueous extract of pollen of Zea mays L. by weight of the total weight of the extract;
0.01% to 5% aqueous extract of pollen of Pinus sylvestris L. by weight of the total weight of the extract;
3% to 30% aqueous extract of pollen of Dactylis glomerata L. by weight of the total weight of the extract,
an aqueous extract of plant seeds belonging to the genus Cucurbita containing fatty acids at a content of less than 10% by weight of the total weight of the extract,
vitamin E or its esters; and
an aqueous extract of the pistil of Zea mays L.,
administering a daily dose to a woman in need thereof, and
wherein the lower urinary tract symptoms (LUTS) associated with the filling, micturition and/or post-micturition phases in women is urinary incontinence.

### Claim 7 (depends on 6)

The method of claim 6, wherein the oral composition is in the form of a tablet, capsule, soft gel, semi-solid, solid, liquid, or powder.

### Claim 8 (depends on 6)

The method of claim 6, wherein the daily dose is in a range of 360 mg to 1000 mg.

### Claim 9 (depends on 8)

The method of claim 8, wherein the daily dose is administered for a period of at least one month.

### Claim 10 (depends on 6)

The method of claim 6, wherein the urinary incontinence comprises stress urinary incontinence, urgent urinary incontinence, or combinations thereof.

### Claim 11 (depends on 10)

The method of claim 10, wherein administering the daily dose is at a time of day for reducing the nocturnal micturition frequency inducing an awakening.

### Claim 12 (depends on 6)

The method of claim 6, wherein
the aqueous pollen extract is 5% to 40 by weight of the total weight of the composition;
the aqueous extract of Cucurbita seed is 20% to 80% by weight of the total weight of the composition;
the vitamin E or its esters are 0.1% to 10% by weight of the total weight of the composition.

### Claim 13 (depends on 6)

The method of claim 6, wherein aqueous extract of the pistil of Zea mays L. is present as 0.1% to 10% weight of the total weight of the extract.

### Claim 14 (depends on 1)

The composition of claim 1, wherein
the aqueous pollen extract is 5% to 40 by weight of the total weight of the composition;
the aqueous extract of Cucurbita seed is 20% to 80% by weight of the total weight of the composition;
the vitamin E or its esters are 0.1% to 10% by weight of the total weight of the composition.

### Claim 15 (depends on 1)

The composition of claim 1, wherein aqueous extract of the pistil of Zea mays L. is present as 0.1% to 10% weight of the total weight of the extract.
