U.S. patent application number 16/157154 was filed with the patent office on 2019-02-07 for hairball control through dietary mineral limitation.
This patent application is currently assigned to Hill's Pet Nutrition, Inc.. The applicant listed for this patent is Hill's Pet Nutrition, Inc.. Invention is credited to Dennis JEWELL, Luis MONTELONGO.
Application Number | 20190037888 16/157154 |
Document ID | / |
Family ID | 47222340 |
Filed Date | 2019-02-07 |
United States Patent
Application |
20190037888 |
Kind Code |
A1 |
JEWELL; Dennis ; et
al. |
February 7, 2019 |
Hairball Control Through Dietary Mineral Limitation
Abstract
The present invention relates to methods for controlling
hairball formation in animals, particularly for treating and/or
preventing hairball formation, elimination, and/or discharge by
companion animals, including cats and dogs, by limitation of
dietary minerals. The methods comprise feeding the animals in need
of such treatment compositions comprising from 0.60% to 0.74%
calcium by dry weight of the composition; from 0.50% to 0.69%
phosphorous by dry weight of the composition; and from 0.06% to
0.28% sodium by dry weight of the composition, in an amount and for
a time sufficient for treatment and/or prevention of hairball
formation in the animal.
Inventors: |
JEWELL; Dennis; (Lawrence,
KS) ; MONTELONGO; Luis; (Lawrence, KS) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hill's Pet Nutrition, Inc. |
Topeka |
KS |
US |
|
|
Assignee: |
Hill's Pet Nutrition, Inc.
Topeka
KS
|
Family ID: |
47222340 |
Appl. No.: |
16/157154 |
Filed: |
October 11, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14441518 |
May 8, 2015 |
10117446 |
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PCT/US2012/065253 |
Nov 15, 2012 |
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16157154 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23V 2250/1614 20130101;
A23V 2250/1578 20130101; A23K 20/163 20160501; A23K 50/40 20160501;
A23V 2250/1618 20130101; A23K 20/22 20160501; A23K 20/147 20160501;
A23K 20/26 20160501; A23K 20/158 20160501; A23V 2002/00 20130101;
A23K 20/24 20160501; A23V 2002/00 20130101; A23V 2250/1578
20130101; A23V 2250/1614 20130101; A23V 2250/1618 20130101 |
International
Class: |
A23K 20/22 20060101
A23K020/22; A23K 20/24 20060101 A23K020/24 |
Claims
1. A method for reducing hairball formation in an animal in need
thereof, the method comprising: feeding the animal a previous diet
comprising greater than 0.74% calcium, greater than 0.69%
phosphorus, and greater than 0.28% sodium, each by dry weight of
the composition; reducing amounts of calcium, phosphorus, and
sodium consumed by the animal, wherein reducing the amount of
calcium, phosphorus, and sodium comprises: feeding the animal a
composition comprising less than or equal to 0.74% calcium, less
than or equal to 0.69% phosphorous, and less than or equal to 0.28%
sodium, each by dry weight of the composition, wherein the
composition is fed to the animal in an amount and for a time
sufficient to reduce a frequency of hairball discharge by the
animal; and reducing the frequency of hairball discharged by the
animal.
2. The method of claim 1, wherein the animal is a non-human
animal.
3. The method of claim 1, wherein the animal is a companion
animal.
4. The method of claim 3, wherein the animal is a feline.
5. The method of claim 3, wherein the animal is a canine.
6. The method of claim 1, wherein the composition is a
nutritionally complete diet.
7. A food composition comprising: from 5% to 75% protein by dry
weight of the composition; from 5% to 50% fat by dry weight of the
composition; from 5% to 75% carbohydrate by weight of the
composition; less than or equal to 0.74% calcium by dry weight of
the composition; less than or equal to 0.69% phosphorous by dry
weight of the composition; less than or equal to 0.28% sodium by
dry weight of the composition; wherein the food composition is
suitable for consumption by an animal; and wherein the composition
is effective for reducing hairball formation in the animal.
8. The composition of claim 7, comprising from 0.60% to 0.74%
calcium by dry weight of the composition.
9. The composition of claim 8, comprising from 0.70% to 0.74%
calcium by dry weight of the composition.
10. The composition of claim 9, comprising from 0.50% to 0.69%
phosphorous by dry weight of the composition.
11. The composition of claim 10, comprising from 0.60% to 0.69%
phosphorous by dry weight of the composition.
12. The composition of claim 11, comprising from 0.06% to 0.28%
sodium by dry weight of the composition.
13. The composition of claim 12, comprising from 0.10% to 0.28%
sodium by dry weight of the composition.
14. The composition of claim 13, comprising from 0.20% to 0.28%
sodium by dry weight of the composition
15. The composition of claim 7, comprising 0.74% calcium, 0.69%
phosphorous, and 0.28% sodium, each by dry weight of the
composition.
16. The composition of claim 7, wherein the animal is a companion
animal.
17. The method of claim 16, wherein the companion animal is a
feline.
18. The method of claim 16, wherein the companion animal is a
canine.
19. A method for preparing a food product for reducing hairball
formation in an animal in need thereof, the method comprising:
admixing suitable sources of protein, fat, carbohydrate, minerals,
and vitamins; and processing the mixture to provide the food
product; adjusting the sources of protein, fat, carbohydrate,
minerals, and vitamins such that the food product comprises: less
than or equal to 0.74% calcium, less than or equal to 0.69%
phosphorous, and less than or equal to 0.28% sodium, each by dry
weight of the food product.
20. The method of claim 19, wherein adjusting the sources of
protein, fat, carbohydrate, minerals, and vitamins comprises:
reducing the amount of calcium to less than or equal to 0.74%, by
dry weight of the food product; reducing the amount of phosphorus
to less than or equal to 0.69%, by dry weight of the food product;
and reducing the amount of sodium to less than or equal to 0.28%,
by dry weight of the food product.
Description
FIELD OF THE INVENTION
[0001] The present disclosure relates to methods for treatment
and/or prevention of gastrointestinal bezoars ("hairballs") in
animals, to compositions for use in those methods, and to processes
for the preparation of such compositions. In particular, the
present disclosure relates to methods and compositions for the
treatment and/or prevention of hairballs in companion animals,
e.g., cats and dogs.
BACKGROUND OF THE INVENTION
[0002] Bezoars are any of several types of solid or semi-solid
masses of indigestible material found in the stomach of humans and
many animals including cattle, cats, rats, rabbits, and
non-primates. Trichobezoars, which contain a mesh of ingested hair,
are known to entrap undigested dietary fat in the hair mesh. The
terms bezoars, trichobezoars, and hairballs will be used
interchangeably throughout this application. While the incidence of
bezoars is generally very low in humans, a somewhat greater risk
exists among mentally or emotionally challenged children,
particularly humans who habitually pluck their hair
(trichotillomania) and/or eat their hair (trichopagia).
[0003] Animals that constantly groom themselves, such as cats and
rabbits, regularly ingest large quantities of hair. Normally, the
ingested hair passes through the gastrointestinal tract of the
animal and is excreted in the feces. However, the ingestion of
large quantities of hair may cause the hair to accumulate in the
stomach and form a hairball or trichobezoar. A hairball is
typically composed of hair, mucous, water, food particles and
mineral salts. Any ingested hair that is not digested or does not
otherwise pass down the digestive tract may accumulate in the
stomach and form an over hairball. The most common physiological
consequences thereof are diarrhea and vomiting. A hairball can be
harmful to the animal if it impedes the normal digestive process by
blocking the pylorus and preventing the passage of digesta down the
gastrointestinal tract. More frequently, hairballs are nothing more
than a nuisance to the animal and its owner. For example, the cat
will attempt to eliminate the hairball from the stomach through the
vomiting reflex. A hairball may produce constipation and defecation
difficulties if it passes from the stomach and becomes lodged in
the lower bowel.
[0004] Approaches to the treatment of hairballs have included
administration of compositions and foods comprising fiber
supplements, fat emulsifiers, lubricants, malt syrup emulsion,
mineral oil, petrolatum, and proteolytic enzymes (bromelain).
However, there remains a need for methods and compositions for the
treatment and/or prevention of hairballs in mammals in need thereof
and, in particular, there remains a need for methods and
compositions for the treatment and/or prevention of hairballs in
non-human animals, including companion animals, e.g., cats and
dogs.
BRIEF SUMMARY OF THE INVENTION
[0005] The present invention is directed to a method for treatment
and/or prevention of hairball formation in an animal in need
thereof, which comprises feeding the animal a composition
comprising less than or equal to 0.74% calcium by dry weight of the
composition; less than or equal to 0.69% phosphorous by dry weight
of the composition; and less than or equal to 0.28% sodium by dry
weight of the composition. According to this method, the
composition is administered in an amount and for a time sufficient
for treatment and/or prevention of hairball formation in and/or
hairball elimination by the animal.
[0006] In one embodiment, the animal in need thereof is a cat.
[0007] In another embodiment, the animal in need thereof is a
dog.
[0008] In still another embodiment, the animal in need thereof is a
rabbit.
[0009] The present invention is further directed to a food
composition comprising from 5% to 75% protein by dry weight of the
composition; from 5% to 50% fat by dry weight of the composition;
from 5% to 75% carbohydrate by weight of the composition; less than
or equal to 0.74% calcium by dry weight of the composition; less
than or equal to 0.69% phosphorous by dry weight of the
composition; less than or equal to 0.28% sodium by dry weight of
the composition; wherein the food composition is suitable for
consumption by an animal, the food composition is effective for
treatment and/or prevention of hairball formation in the
animal.
[0010] The present invention is still further directed to a method
for preparing a food product, comprising admixing suitable sources
of protein, fat, carbohydrate, minerals, and vitamins; and
processing the mixture to provide the food product, which food
product is suitable for consumption by a companion animal; and
comprises less than or equal to 0.74% calcium by dry weight of the
composition, less than or equal to 0.69% phosphorous by dry weight
of the composition, and less than or equal to 0.28% sodium by dry
weight of the composition. In a specific embodiment, the food
composition prepared according to the invention also comprises 5%
to 75% protein by dry weight of the composition; from 5% to 50% fat
by dry weight of the composition; from 5% to 75% carbohydrate by
weight of the composition.
[0011] Further areas of applicability of the present invention will
become apparent from the detailed description provided hereinafter.
It should be understood that the detailed description and specific
examples, while indicating the preferred embodiment of the
invention, are intended for purposes of illustration only and are
not intended to limit the scope of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0012] The following description of the preferred embodiment(s) is
merely exemplary in nature and is in no way intended to limit the
invention, its application, or uses.
[0013] Unless otherwise specified, all percentages and amounts
expressed herein and elsewhere in the specification should be
understood to refer to percentages by weight. The amounts given are
based on the active weight of the material. As used throughout,
ranges are used as shorthand for describing each and every value
that is within the range. Any value within the range can be
selected as the terminus of the range. In addition, all references
cited herein are hereby incorporated by reference in their
entireties. In the event of a conflict in a definition in the
present disclosure and that of a cited reference, the present
disclosure controls.
Definitions
[0014] It is contemplated that the invention described herein is
not limited to the particular methodology, protocols, ingredients
and reagents described, as these may vary. It is also to be
understood that the terminology used herein is for the purpose of
describing particular embodiments only, and is not intended to
limit the scope of the present invention in any way.
[0015] Unless defined otherwise, all technical and scientific terms
used herein have the same meanings as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
any methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
invention, the preferred methods, devices and materials are now
described. All publications mentioned herein are incorporated by
reference for the purpose of describing and disclosing the
materials and methodologies that are reported in the publication,
which might be used in connection with the invention.
[0016] As used herein and in the appended claims, the singular
forms "a", "an", and "the" include plural reference unless the
context clearly dictates otherwise.
[0017] As used herein, the term "animal" is a human, a non-human
animal, or a non-human mammal, where the term non-human animal
includes non-human primates (e.g., monkeys, chimpanzees, apes
etc.), companion animals and house pets (dogs, cats, rabbits etc.),
laboratory animals, domesticated animals, livestock and farm
animals (e.g., horses, goats, sheep, swine, llamas, alpacas, bovine
animals etc.). In one embodiment, the animal is a non-primate
mammal. In another embodiment, the animal is a non-human primate.
In a more specific embodiment, the animal is a domesticated
companion animal or "house" pet, such as a female feline or female
canine.
[0018] According to the invention, the phrase "animal in need
thereof," refers to a human or a non-human animal for whom or for
which treatment, prevention, or control of hairball formation
and/or hairball elimination is indicated. Such animals include
those known to be currently afflicted with hairball formation and
those known to have been afflicted with hairball formation in the
past, as well as those expected to be or are at risk of being
afflicted with hairball formation based on, inter alia, a tendency
or habit of consuming hair, e.g., by animals that groom themselves
or others by licking their fur, or animals afflicted with
trichophagia, trichotillomania or pica. The accumulation of groomed
hair in the stomach of such animals, e.g., cats, rabbits, dogs and
other animals that groom themselves, predisposes the animal to
coughing up trichobezoars ("hairballs"). In severe cases, it may
lead to blockage of the gastrointestinal tract.
[0019] The term "preventing," as used herein, means e.g., to
completely or almost completely stop as well as to substantially
reduce hairball formation, elimination, and/or discharge (e.g., by
coughing up, vomiting and/or diarrhea) by the animal in need
thereof.
[0020] The term "treating," as used herein, means to cure, inhibit,
arrest the development, relieve the symptoms or effects of,
ameliorate, or cause the reduction of hairball formation,
discharge, and/or elimination by the animal in need of the claimed
treatment.
[0021] Accordingly, it should be recognized that the terms
"preventing," treating," and "controlling," are not intended to
limit the scope of the invention and that there can be overlap
amongst these terms.
[0022] The term "cat" includes those cats which are companion
animals known as domestic cats or house cats, or Felis domesticus.
The term cat is synonymous with the term feline.
[0023] The term "companion animal" used in the present invention
includes any non-human animal suitable for being kept as a pet by
humans including a dog, a cat, and a rodent. All aspects of the
present invention are preferably for the treatment of cats and/or
dogs.
[0024] The term "dog" includes those dogs which are companion
animals such as Canis familiaris, working dogs and the like. The
term dog is synonymous with the term canine.
[0025] As used herein, "an amount effective", "an effective
amount", and like terms refer to that amount of a material or
composition as described herein that may be effective to achieve a
particular biological result, i.e., hairball control. In specific
embodiments, administration of an effective amount of a composition
of the invention will be for a time sufficient to prevent and/or
reduce hairballs in the animal treated. In a particular embodiment,
the method comprises administration and consumption of a
composition of the invention for a period of time sufficient to
result in reduction in the frequency of hairball elimination by the
animal to an acceptable level; i.e., to a level acceptable to the
patient or, where the patient is an a non-human animal, to a level
acceptable to the owner of that non-human animal. An effective
amount may be based on several factors, including an animal's ideal
weight, the age, gender, and activity of the animal, the
metabolizable energy of the composition, and the frequency of
feeding the compositions of the present invention, e.g., once,
twice, or three times daily, and other compositions fed to the
animal.
[0026] A "food" for "food composition" or pet food composition can,
in some embodiments of the invention, be a nutritionally complete
diet for the intended recipient animal (e.g., a companion animal,
such as a domestic cat or domestic dog).
[0027] As used herein, an "ingredient" refers to any component of a
composition.
[0028] The term "nutrient" refers to a substance that provides
nourishment. In some cases an ingredient may comprise more than one
"nutrient," for example, a composition may comprise corn comprising
important nutrients including both protein and carbohydrate.
[0029] As contemplated herein, the compositions of the present
invention are meant to encompass, but not be limited to,
nutritionally-complete and balanced animal food compositions. A
"nutritionally complete diet" is a diet that includes sufficient
nutrients for maintenance of normal health of a healthy animal on
the diet. Nutritionally complete and balanced pet food
compositions, e.g. for companion felines and canines, are familiar
to one of skill in the art. For example substances such as
nutrients and ingredients suitable for nutritionally complete and
balanced animal feed compositions, and recommended amounts thereof,
may be found for example, in the Official Publication of the
Association of American Feed Control Officials, Inc. (AAFCO),
Atlanta, Ga., (2005).
[0030] As used herein, the term "supplement(s)" include, but are
not limited to, a feed used with another feed to improve nutritive
balance or performance of the total diet for an animal. Supplements
include, but are not limited to, compositions that are fed
undiluted as a supplement to other feeds, offered free choice with
other parts of an animal's ration that are separately available, or
diluted and mixed with an animal's regular feed to produce a
complete feed. The AAFCO guidelines, for example, contain a
discussion relating to supplements in the Official Publication of
the Association of American Feed Control Officials, Inc. (AAFCO),
Atlanta, Ga. (2005). Supplements may be in various forms including,
for example, powders, liquids, syrups, pills, encapsulated
compositions and the like.
Methods of the Invention
[0031] The present invention is directed to methods for the
treatment and/or prevention of hairball formation in an animal in
need thereof, comprising feeding the animal a composition
comprising limited concentrations of three ingredients, calcium,
phosphorous, and sodium. In particular, the compositions comprise
less than or equal to 0.74% calcium by dry weight of the
composition, less than or equal to 0.69% phosphorous by dry weight
of the composition, and less than or equal to 0.28% sodium by dry
weight of the composition.
[0032] These compositions, exemplified by those described below in
greater detail, are administered in an amount and for a time
sufficient for treatment and/or prevention of hairball formation in
the animal.
[0033] In a particular aspect of this embodiment, the composition
administered for treatment and/or prevention of hairball formation
comprises from 0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or
from 0.6% to less than or equal to 0.74% calcium by dry weight of
the composition. The administered compositions, according to these
embodiments, further comprise less than or equal to 0.69%
phosphorous by dry weight of the composition. In various aspects of
these embodiments the administered composition may comprise from
0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to
less than or equal to 0.69% phosphorous by dry weight of the
composition. The administered compositions, according to these
embodiments, further comprise less than or equal to 0.28% sodium by
dry weight of the composition. In various aspects of these
embodiments the administered composition may comprise from 0.05%,
from 0.10%, from 0.15%, from 0.2%, of from 0.25% to less than or
equal to 0.28% sodium by dry weight of the composition. According
to these embodiments, the compositions are administered in an
amount and for a time sufficient for treatment of hairball
formation in the animal.
[0034] In another embodiment, the methods of the present invention
are directed to a method for the treatment and/or prevention of
hairball formation in an animal in need thereof comprising
administration of a composition of the present invention, which
compositions comprise 0.74% calcium by dry weight of the
composition, 0.69% phosphorous by dry weight of the composition,
and 0.28% sodium by dry weight of the composition, wherein those
compositions are administered in an amount and for a time
sufficient for treatment and/or prevention of hairball formation in
the animal.
[0035] In a specific embodiment, the methods of the present
invention are directed to a method for the treatment of hairball
formation in an animal in need thereof comprising administration of
a composition of the present invention, which compositions comprise
less than or equal to 0.74% calcium by dry weight of the
composition, less than or equal to 0.69% phosphorous by dry weight
of the composition, and less than or equal to 0.28% sodium by dry
weight of the composition, wherein those compositions are
administered in an amount and for a time sufficient for treatment
of hairball formation in the animal.
[0036] In particular aspects of this embodiment, the compositions
administered for treatment of hairball formation comprise from
0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to
less than or equal to 0.74% calcium by dry weight of the
composition. The administered compositions, according to these
embodiments, further comprise less than or equal to 0.69%
phosphorous by dry weight of the composition. In various aspects of
these embodiments the administered composition may comprise from
0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to
less than or equal to 0.69% phosphorous by dry weight of the
composition. The administered compositions, according to these
embodiments, further comprise less than or equal to 0.28% sodium by
dry weight of the composition. In various aspects of these
embodiments the administered composition may comprise from 0.05%,
from 0.10%, from 0.15%, from 0.2%, of from 0.25% to less than or
equal to 0.28% sodium by dry weight of the composition. According
to these embodiments, the compositions are administered in an
amount and for a time sufficient for treatment of hairball
formation in the animal.
[0037] In a specific embodiment, the methods of the present
invention are directed to a method for the treatment of hairball
formation in an animal in need thereof comprising administration of
a composition of the present invention, which compositions comprise
0.74% calcium by dry weight of the composition, 0.69% phosphorous
by dry weight of the composition, and 0.28% sodium by dry weight of
the composition, wherein those compositions are administered in an
amount and for a time sufficient for treatment and/or prevention of
hairball formation in the animal.
[0038] In another specific embodiment, the methods of the present
invention are directed to a method for the prevention of hairball
formation in an animal in need thereof comprising administration of
a composition of the present invention, which compositions comprise
less than or equal to 0.74% calcium by dry weight of the
composition, less than or equal to 0.69% phosphorous by dry weight
of the composition, and less than or equal to 0.28% sodium by dry
weight of the composition, wherein those compositions are
administered in an amount and for a time sufficient for prevention
of hairball formation in the animal.
[0039] In another embodiment, the methods of the present invention
are directed to a method for the prevention of hairball formation
in an animal in need thereof comprising administration of
compositions of the present invention, which compositions comprise
from 0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6%
to less than or equal to 0.74% calcium by dry weight of the
composition. The administered compositions, according to these
embodiments, further comprise less than or equal to 0.69%
phosphorous by dry weight of the composition. In various aspects of
these embodiments the administered composition may comprise from
0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to
less than or equal to 0.69% phosphorous by dry weight of the
composition. The administered compositions, according to these
embodiments, further comprise less than or equal to 0.28% sodium by
dry weight of the composition. In various aspects of these
embodiments the administered composition may comprise from 0.05%,
from 0.10%, from 0.15%, from 0.2%, of from 0.25% to less than or
equal to 0.28% sodium by dry weight of the composition. According
to these embodiments, the compositions are administered in an
amount and for a time sufficient for prevention of hairball
formation in the animal.
[0040] In still another specific embodiment, the methods of the
present invention are directed to a method for the prevention of
hairball formation in an animal in need thereof comprising
administration of a composition of the present invention, which
compositions comprise 0.74% calcium by dry weight of the
composition, 0.69% phosphorous by dry weight of the composition,
and 0.28% sodium by dry weight of the composition, wherein those
compositions are administered in an amount and for a time
sufficient for prevention of hairball formation in the animal.
[0041] The term "treatment of hairball formation" in an animal in
need thereof, as used herein, encompasses reducing or controlling
the frequency of hairball discharge or elimination by the treated
animal and/or reducing or controlling the size of hairballs
discharged or eliminated by the animal. That is, as used herein,
the phrases "treatment of hairball formation" and "prevention of
hairball formation" refer to and encompass reduction in the
frequency or the size or both the frequency and size of hairball
elimination from the treated animal.
[0042] The terms treat and treating therefore, encompass any such
indication of success in the treatment or amelioration of hairball
production by the treated animal in need thereof. In the context of
the present invention, treatment and/or prevention therefore
encompasses both therapeutic and prophylactic treatment of hairball
discharge by an animal in need thereof. The claimed methods
therefore may involve complete or partial eradication of the
hairball production, discharge, and elimination by the animal,
including cessation, amelioration, or arresting subsequent
development hairball formation and/or discharge, and/or prevention
of, or reduction of risk of, subsequent occurrence of hairball
formation and/or discharge by the treated animal.
[0043] According to the claimed methods, the compositions of the
invention are orally administered to the animal in need of
treatment or prevention of hairballs formation and/or discharge or
elimination of hairballs. The compositions are administered
typically at least once weekly, at least three times a week or at
least once a day. In certain embodiments the compositions are
provided ad libitum to the animal in need of the claimed treatment.
The compositions are administered a time sufficient for elimination
or reduction of hairball formation and/or elimination to an
acceptable frequency.
Compositions of the Invention
[0044] Compositions of the present invention include food
compositions comprising from 5% to 75% protein by dry weight of the
composition, from 5% to 50% fat by dry weight of the composition,
from 5% to 75% carbohydrate by weight of the composition, less than
or equal to 0.74% calcium by dry weight of the composition, less
than or equal to 0.69% phosphorous by dry weight of the
composition, and less than or equal to 0.28% sodium by dry weight
of the composition, wherein the food composition is suitable for
consumption by an animal, and wherein the composition is effective
for treatment and/or prevention of hairball formation in the
animal.
[0045] In preparing a composition of the present invention, the
components of the composition are adjusted so as to contain less
than or equal to 0.74% calcium, less than or equal to 0.69%
phosphorous, and less than or equal to 0.28% sodium, each by dry
weight of the composition.
[0046] In particular embodiments of the present invention, the
components of the composition are adjusted so as to contain from
0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to
less than or equal to 0.74% calcium by dry weight of the
composition; from 0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%,
or from 0.6% to less than or equal to 0.69% phosphorous by dry
weight of the composition, and from 0.05%, from 0.10%, from 0.15%,
from 0.2%, of from 0.25% to less than or equal to 0.28% sodium by
dry weight of the composition.
[0047] The sources of calcium, phosphorous, and sodium may, for
example, be incorporated into the composition during the processing
of the formulation, such as during and/or after mixing of other
components of the composition. The compositions to be administered
according to the methods of the invention may be formulated as an
animal food composition that, in certain embodiments, is a
nutritionally-balanced and/or nutritionally-complete animal food
product or diet. In other embodiments, the composition is
formulated and prepared as a nutritional supplement, a treat, or a
toy.
[0048] For example, a nutritionally complete and balanced cat food
composition of the present invention may comprise: from 0 to 90%,
from 5% to 75%, from 10% to 60% protein, and from 15% to 50% by
weight of protein; from 0% to 75%, from 2% to 60%, and from 5% to
50% by weight of carbohydrate; from 2% to 60%, from 5% to 50%, and
from 10% to 35% by weight of fat. The compositions may further
contain from 0 to 15%, or from 2% to 8%, by weight of vitamins
(e.g., vitamin E) and minerals, antioxidants, and other nutrients,
e.g. amino acids (e.g., methionine, DL-methionine, and
L-methionine) and antioxidants, which support the nutritional needs
of the animal. These compositions of the invention less than or
equal to 0.74% calcium, less than or equal to 0.69% phosphorous,
and less than or equal to 0.28% sodium, each by dry weight of the
composition.
[0049] The composition of these nutritionally complete cat food
formulations may be adjusted to so as to contain from 0.1%, from
0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less than or
equal to 0.74% calcium by dry weight of the composition; from 0.1%,
from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less
than or equal to 0.69% phosphorous by dry weight of the
composition, and from 0.05%, from 0.10%, from 0.15%, from 0.2%, of
from 0.25% to less than or equal to 0.28% sodium by dry weight of
the composition.
[0050] For example, a nutritionally complete and balanced dog food
composition of the present invention may comprise: from 0 to 90%,
from 5% to 75%, from 10% to 60% protein, and from 15% to 50% by
weight of protein; from 0% to 90%, from 2% to 80%, from 5% to 75%,
and from 10% to 50% by weight of carbohydrate; from 2% to 60%, from
5% to 50%, and from 10% to 35% by weight of fat. The compositions
may further contain from 0 to 15%, or from 2% to 8%, by weight of
vitamins and minerals, antioxidants, and other nutrients which
support the nutritional needs of the animal. These compositions of
the invention contain less than or equal to 0.74% calcium, less
than or equal to 0.69% phosphorous, and less than or equal to 0.28%
sodium, each by dry weight of the composition.
[0051] The composition of these nutritionally-complete dog food
formulations may be adjusted to so as to contain from 0.1%, from
0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less than or
equal to 0.74% calcium by dry weight of the composition; from 0.1%,
from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less
than or equal to 0.69% phosphorous by dry weight of the
composition, and from 0.05%, from 0.10%, from 0.15%, from 0.2%, of
from 0.25% to less than or equal to 0.28% sodium by dry weight of
the composition.
[0052] In formulating the compositions of the present invention,
particularly where the compositions are to be prepared as
nutritionally-complete and nutritionally-balanced diets or as
components thereof, those compositions should consider the
suggested minimum dietary requirements for various dietary
components, including, e.g., calcium, phosphorous, and sodium, of
the animal in need of treatment and/or prevention of hairball
formation. The suggested minima of the ranges of calcium,
phosphorous, and sodium are known to those of ordinary skill in the
art or are readily determined from standard sources, e.g., from the
AAFCO guidelines cited above, and the like. For example, for a cat,
the compositions may contain, in certain embodiments, a minimum of
0.6% calcium, 0.5% phosphorous and 0.06% sodium.
[0053] Sources of proteins, carbohydrates, fats, vitamins,
minerals, balancing agents, and the like, suitable for inclusion in
the compositions of the invention, and particularly in the food
products of the invention to be administered in the claimed
methods, may be selected from among those conventional materials
known to those of ordinary skill in the art.
[0054] Proteins useful as ingredients of the food compositions of
the present invention may be from any source, including, for
example, proteins from animal sources, such as meat protein
isolate, whey protein isolate, mixtures thereof, and the like, as
well as vegetable sources, such as soy protein isolate, corn, corn
gluten meal, wheat gluten, mixtures thereof, and the like.
Additional sources of protein may include one or more of the
following: animal proteins, including mammalian, avian protein,
reptilian, amphibian, fish, invertebrate proteins and combinations
thereof e.g. from any of cattle, sheep, pig, goat, deer, rabbit,
horse, kangaroo, their milk, curds, whey or blood, and internal
tissues and organs such as smooth muscle, striate muscle, liver,
kidney, intestine or heart; avian protein sources encompass
chicken, chicken by-products, turkey, goose, duck, ostrich, quail,
pigeon, their eggs and internal tissues and organs such as smooth
muscle, striate muscle, liver, kidney, intestine or heart;
amphibian sources include frog or salamander, reptilian protein
sources include alligator, lizard, turtle and snake; fish protein
sources include catfish, herring, salmon, tuna, bluefish, cod,
halibut, trout, swordfish and their eggs; and invertebrate protein
sources include lobster, crab, clams, mussels or oysters, and
combinations thereof.
[0055] The carbohydrate component of compositions of the present
invention may be from any source, and may enter the food
composition as part of another ingredient, such as the protein
source. In certain embodiments, carbohydrates useful as ingredients
of the food compositions of the present invention include
polysaccharides (e.g., starches and dextrins) and sugars (e.g.,
sucrose, lactose, maltose, glucose, and fructose) that are
metabolized for energy when hydrolyzed. Examples of carbohydrate
sources suitable for inclusion in the compositions disclosed herein
include, but are not limited to, corn, whole yellow corn, brewers
rice, corn gluten meal, grain sorghum, wheat, barley, and rice.
[0056] Fats useful as ingredients of the food compositions of the
present invention may be from any source, such as but not limited
to poultry fat, beef tallow, lard, choice white grease, soybean
oil, corn oil, canola oil, sunflower oil, mixtures thereof, and the
like. The fat may be incorporated completely within the food
composition, deposited on the outside of the food composition, or a
mixture of the two methods.
[0057] In one embodiment, the composition to be administered in the
claimed methods is formulated and prepared as a supplement.
Supplements include, for example, a food product, feed, or pet
food, that can be used with another food product, feed, or pet food
composition to improve the nutritive balance or performance of the
total. Contemplated supplements include compositions that are fed
undiluted as a supplement to other feeds or pet foods, offered free
choice with other parts of an animal's ration that are separately
available, or diluted and mixed with an animal's regular feed or
pet food to produce a complete feed or pet food. The AAFCO, for
example, has provided a discussion relating to supplements in the
American Feed Control Officials, Incorp. Official Publication
(2003), at page 220. Supplements may be in various forms including,
for example, powders, liquids, syrups, pills, encapsulated
compositions, etc.
[0058] In another embodiment, treats of the present invention can
be prepared by, for example, an extrusion or baking process similar
to those described above for dry food to provide an edible product
comprising less than or equal to 0.74% calcium, less than or equal
to 0.69% phosphorous, and less than or equal to 0.28% sodium, each
by dry weight of the treat. Treats include, for example,
compositions that are given to an animal to entice the animal to
eat during a non-meal time. Treats may be nutritional, wherein the
composition comprises one or more nutrients, and may, for example,
have a composition as described above for food. Non-nutritional
treats encompass any other treats that are non-toxic. Compositions
of the invention can be coated onto the treat, incorporated into
the treat, or both. Again, formulation of treats may be adjusted to
contain from 0.1%, from 0.2%, from 0.3%, from 0.4%, from 0.5%, or
from 0.6% to less than or equal to 0.74% calcium by dry weight of
the composition; from 0.1%, from 0.2%, from 0.3%, from 0.4%, from
0.5%, or from 0.6% to less than or equal to 0.69% phosphorous by
dry weight of the composition, and from 0.05%, from 0.10%, from
0.15%, from 0.2%, of from 0.25% to less than or equal to 0.28%
sodium by dry weight of the composition.
[0059] In another embodiment, the animal toy is a chewable or
consumable toy, that is typically prepared by coating any existing
toy with a formulation that provides less than or equal to 0.74%
calcium, less than or equal to 0.69% phosphorous, and less than or
equal to 0.28% sodium, each by dry weight of the toy. Toys
therefore include, for example, chewable toys. Contemplated toys
for dogs include, for example, artificial bones. In certain
embodiments, the composition can form a coating on the surface of
the toy or on the surface of a component of the toy, or it can be
incorporated partially or fully throughout the toy, or both, to
provide less than or equal to 0.74% calcium, less than or equal to
0.69% phosphorous, and less than or equal to 0.28% sodium, each by
dry weight of the toy. The toys of the invention, in certain
embodiments, may be formulated so as to contain from 0.1%, from
0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less than or
equal to 0.74% calcium by dry weight of the composition; from 0.1%,
from 0.2%, from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less
than or equal to 0.69% phosphorous by dry weight of the
composition, and from 0.05%, from 0.10%, from 0.15%, from 0.2%, of
from 0.25% to less than or equal to 0.28% sodium by dry weight of
the composition.
[0060] A wide range of suitable toys are currently marketed. See,
e.g., U.S. Pat. No. 5,339,771 (and references disclosed in U.S.
Pat. No. 5,339,771). See also, e.g., U.S. Pat. No. 5,419,283 (and
references disclosed in U.S. Pat. No. 5,419,283). It should be
recognized that this invention contemplates both partially
consumable toys (e.g., toys comprising plastic components) and
fully consumable toys (e.g., rawhides and various artificial
bones). It should be further recognized that this invention
contemplates toys for both human and non-human use, particularly
for companion, farm, and zoo animal use, and particularly for cat,
dog, or rabbit use.
Preparation of the Compositions of the Invention
[0061] The compositions of the invention, which are to be
administered to animals in need of the methods disclosed herein,
may be prepared as food products suitable for consumption by the
animals. These food products may be of any consistency or moisture
content; i.e., the compositions of the present invention may be
moist, semi-moist, or dry food products. "Moist" food products are
generally those with a moisture content of from 60% to 90% or
greater. "Dry" food products are generally those with a moisture
content of from 3% to 11%, and are often manufactured in the form
of small pieces or kibbles. "Semi-moist food products generally
have a moisture content of from 25% to 35%. The food products of
the present invention may also include components of more than one
consistency, for example, soft, chewy meat-like particles or pieces
as well as kibble having an outer cereal component or coating and
an inner "cream" component, e.g., as described in U.S. Pat. No.
6,517,877.
[0062] In certain embodiments, the food products may be prepared in
a canned or wet form using conventional food preparation processes
known to those of ordinary skill in the art. Typically, ground
animal proteinaceous tissues are mixed with the other ingredients,
such as cereal grains, suitable carbohydrate sources, fats, oils,
and balancing ingredients, including special purpose additives such
as vitamin and mineral mixtures, inorganic salts, cellulose, beet
pulp and the like, and water in an amount sufficient for
processing. The ingredients are mixed in a vessel suitable for
heating while blending the components. Heating the mixture is
carried out using any suitable manner, for example, direct steam
injection or using a vessel fitted with a heat exchanger. Following
addition of all of the ingredients of the formulation, the mixture
is heated to a temperature of from 10.degree. C. to 100.degree. C.
(50.degree. F. to 212.degree. F.). Although temperatures outside
this range can be used, they may be commercially-impractical
without the use of other processing aids. When heated to the
appropriate temperature, the material will typically be in the form
of thick liquid, which is dispensed into cans. A lid is applied and
the container is hermetically sealed. The sealed can is then placed
in convention equipment designed for sterilization of the contents.
Sterilization is usually accomplished by heating to temperatures of
greater than 230.degree. C. for an appropriate time depending on
the temperature used, the nature of the composition, and related
factors. The compositions and food products of the present
invention can also be added to or combined with food compositions
before, during, or after their preparation, provided the resulting
mixture contains less than or equal to 0.74% calcium by dry weight
of the composition, less than or equal to 0.69% phosphorous by dry
weight of the composition; and less than or equal to 0.28% sodium
by dry weight of the composition.
[0063] In other embodiments, the ingredients of the composition are
adjusted so as to contain from 0.1%, from 0.2%, from 0.3%, from
0.4%, from 0.5%, or from 0.6% to less than or equal to 0.74%
calcium by dry weight of the composition; from 0.1%, from 0.2%,
from 0.3%, from 0.4%, from 0.5%, or from 0.6% to less than or equal
to 0.69% phosphorous by dry weight of the composition, and from
0.05%, from 0.10%, from 0.15%, from 0.2%, of from 0.25% to less
than or equal to 0.28% sodium by dry weight of the composition.
[0064] In other embodiments, the food products may be prepared in a
dry form using conventional processes known to those of ordinary
skill in the art. Typically, dry ingredients, including dried
animal protein, plant protein, grains and the like are ground and
mixed together. Liquid or moist ingredients, including fats, oils
water, animal protein, water, and the like are added combined with
the dry materials. The specific formulation, order of addition,
combination, and methods and equipment used to combine the various
ingredients can be selected from those known in the art. For
example, in certain embodiments, the resulting mixture is process
into kibbles or similar dry pieces, which are formed using an
extrusion process in which the mixture of dry and wet ingredients
is subjected to mechanical work at high pressure and temperature,
forced through small openings or apertures, and cut off into the
kibbles, e.g., with a rotating knife. The resulting kibble can be
dried and optionally coated with one or more topical coatings
comprising, e.g., flavors, fats, oils, powdered ingredients, and
the like. Kibbles may also be prepared from dough by baking, rather
than extrusion, in which the dough is placed into a mold before
dry-heat processing.
[0065] In preparing a composition for use with the methods of the
present invention, any ingredient generally may be incorporated
into the composition during the processing of the formulation,
e.g., during and/or after mixing of the other components of the
composition. Distribution of these components into the composition
can be accomplished by conventional means. In certain embodiments,
ground animal and/or poultry proteinaceous tissues are mixed with
other ingredients, including nutritional balancing agents,
inorganic salts, and may further include cellulose, beet pulp,
bulking agents and the like, along with sufficient water for
processing.
[0066] In particular embodiments, the compositions are formulated
so as to be easier to chew. In specific embodiments, the
compositions and food products are formulated to address specific
nutritional differences between species and breeds of animals, as
well as one of more of the attributes of the animal. For example,
canine and feline foods, for example, are typically formulated
based upon the life stage, age, size, weight, body composition, and
breed. Accordingly, in one specific embodiment, the present
invention is directed to a method for preparing a food product, the
method comprising, admixing suitable sources of protein, fat,
carbohydrate, minerals, and vitamins, and processing the mixture to
provide the food product, to provide a food product suitable for
consumption by an animal, e.g., a companion animal such a feline or
canine companion animal, in which the food product comprises from
0.60% to 0.74% calcium by dry weight of the food product, from
0.50% to 0.69% phosphorous by dry weight of the food product, and
from 0.06% to 0.28% sodium by dry weight of the food product.
EXAMPLE
[0067] The invention is further described in the following Example,
which is merely illustrative and does not in any way limit the
scope of the invention as described and claim.
Hairball Control in Felines by Limitation of Dietary Minerals
[0068] Eighteen cats, previously identified as hairball formers,
were enrolled in the present study. Of these, one cat was removed
from the trial after seven weeks, while the remaining seventeen
cats were able to complete the entire study.
[0069] The study included four temporal segments, which were
designated the "pre-testing" (two weeks), "Period 1," "transition,"
and "Period 2." In the first, all cats were fed an adult feline
diet for two weeks, as a "pre-testing" or "wash-out" diet. This
formulation included poultry by-products, corn and corn-derived
ingredients, fat, vitamins and minerals. After this initial
segment, the cats were divided into two groups.
[0070] The cats of the first group ("Group I") were fed an
Experimental formulation and the cats of the second group ("Group
II") were fed a Control formulation, each for a total of eight
weeks ("Period 1"). The compositions of the Experimental and
Control formulations are provided in Table 1:
TABLE-US-00001 TABLE 1 (All values expressed as % by weight of the
Diet) Ingredient Control Diet Experimental Diet Total Calcium 0.95
0.74 Total Phosphorous 0.86 0.69 Total Sodium 0.54 0.28
[0071] Upon completion of this eight-week segment ("Period 1"), all
of the animals were again fed the adult feline diet noted above
("wash-out" diet) for a two week "transition" period.
[0072] Upon completion of the two week "transition" period cats of
the first group ("Group I") were fed the Control formulation and
the cats of the second group ("Group II") were the Experimental
formulation, each for a total of eight weeks ("Period 2").
[0073] The number of hairballs deposited was recorded for each of
the cats in the study and was scored weekly. These data are
presented in Table 2, below.
TABLE-US-00002 TABLE 2 (Total number of hairballs observed with
each diet within each temporal segment) Total Diet Group 1 Group 2
(Group 1 + Group 2) Wash-out Diet 10 7 17 (Pre-testing period)
Wash-out Diet 8 9 17 (Transition period) Control Diet 63 88 151
Experimental Diet 40 41 81 (Low Ca, P, and Na)
[0074] Table 2 provides the number of hairballs observed for each
group of cats during each time segment. As noted above, Group 1
included 8 cats and Group 2 included 9 cats. As also noted above
the Standard Diet was administered for the Pre-Feeding and
Transition periods, both of which lasted two weeks, while the
Control and Experimental Diets were each fed for an eight week
period. The data of Table 2 illustrate that feeding the
experimental diet, with the indicated lower levels of calcium,
phosphorous, and sodium resulted in substantial decrease in
hairball formation, from a total of 151 with the Control Diet to
only 81 with the Experimental Diet over the eight-week testing
periods, i.e., a decrease of more than 45%.
[0075] While the invention has been described in detail and with
reference to specific examples thereof, it would be apparent to one
skilled in the art that various changes and modification can be
made therein without departing from the spirit and scope
thereof.
[0076] As used throughout, ranges are used as shorthand for
describing each and every value that is within the range. Any value
within the range can be selected as the terminus of the range. In
addition, all references cited herein are hereby incorporated by
reference in their entireties. In the event of a conflict in a
definition in the present disclosure and that of a cited reference,
the present disclosure controls.
* * * * *