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Transcript of Petito et. al. v. Nature's Bounty
8/14/2019 Petito et. al. v. Nature's Bounty
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“EXHIBIT A”
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1 2 )Uni t ed S t a t e s Paten tP e t i t o e t a l .
US006645948B2
U S 6 , 6 4 5 , 9 4 8B2* N o v .1 1 ,2 0 0 3
1 0 )P a t e n t N 0 . :
4 5 )Date o f P a t e n t :
5 4 )
7 6 )
2 1 )2 2 )6 5 )
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5 1 )
5 2 )
5 8 )
5 6 )
1 , 9 5 0 , 1 0 0A4 , 0 0 6 , 2 2 4 A4 , 2 1 6 , 2 0 4 A
NUTRITIONAL COMPOSITION FOR THETREATMENT OF CONNECTIVE T I S S U E
I n v e n t o r s : George D . P e t i t o ,1 8 9 0B u c k n e l lD r . ,B e t h l e h e m ,P A U S ) 1 8 0 1 5 ;A n i t a M.P e t i t o ,1 8 9 0B u c k n e l lD r . ,B e t h l e h e m ,P A U S ) 1 8 0 1 5
N o t i c e : S u b j e c t t o a n y d i s c l a i m e r , t h e t e r m o f t h i sp a t e n t i s e x t e n d e d o r a d j u s t e d u n d e r 3 5U . S . C . 1 5 4 b )b y 0 d a y s .
T h i s p a t e n t i s s u b j e c t t o a t e r m i n a l d i sc l a i m e r .
A p p l . N o . :1 0 / 2 8 7 , 5 9 0F i l e d : N o v . 5 , 2 0 0 2
P r i o r P u b l i c a t i o n D a t a
U S 2 0 0 3 / 0 0 6 9 1 7 1A1 A p r . 1 0 ,2 0 0 3
R e l a t e d U S . A p p l i c a t i o nData
C o n t i n u a t i o n - i n - p a r t o fa p p l i c a t i o n N o . 0 9 / 3 6 0 , 1 6 9 , ? l e do nJ u l .2 6 , 1 9 9 9 , n o w P a t . No. 6 , 4 7 6 , 0 0 5 ,which i s a c o n t i n ua t i o n - i n - p a r t o f a p p l i c a t i o n N o . 0 9 / 0 4 6 , 7 1 0 , ? l e do n M a r .2 4 , 1 9 9 8 , n o w a b a n d o n e d .
I n t . Cl .7 . . . . . . . . . . . . . . . . . .. . A61K 1/7008 ; A61K 8/16;
A61K 3 5 / 3 2US. l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 514/62; 514/2; 514/54;
4 2 4 / 4 4 9Field o f S e a r c h . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 514/62, 2 , 5 4 ;
4 2 4 / 4 4 9
R e f e r e n c e s C i t e d
U . S . PATENT DOCUMENTS
3 / 1 9 3 4 C r a n d a l l , J r .2 / 1 9 7 7 P r u d d e n8 / 1 9 8 0 R o b e r t s o n
4 , 4 5 5 , 3 0 2 A 6 / 1 9 8 4 R o b e r t so n4 , 8 3 7 , 0 2 4 A 6 / 1 9 8 9 M i c h a e l i5 , 1 4 1 , 9 2 8 A 8 / 1 9 9 2 G o l d m a n5 , 2 5 2 , 3 3 9 A 1 0 / 1 9 9 3 C r i s t o f o r i e t a l .5 , 3 6 4 , 8 4 5 A 1 1 / 1 9 9 4 H e n d e r s o n5 , 4 4 2 , 0 5 3 A 8 / 1 9 9 5 d e l l a Va l l e e t a l .5 , 4 9 8 , 6 0 6A 3 / 1 9 9 6 S o l l e t a l .5 , 5 8 7 , 3 6 3 A 1 2 / 1 9 9 6 H e n d e r s o n5 , 8 4 0 , 7 1 5 A 1 1 / 1 9 9 8 F l o r i o5 , 9 2 9 , 0 5 0 A 7 / 1 9 9 9 P e t i t o6 , 4 7 6 , 0 0 5 B1 * 11 / 2 0 0 2 P e t i t o e t a l . . . . . . . . . . . . . . . . .. . 5 1 4 / 6 2
FOREIGN PATENT DOCUMENTS
DE 3445324 1 2 / 1 9 8 6F R 2035781 1 2 / 1 9 7 0GB 896940 5 / 1 9 6 2
OTHER PUBLICATIONS
B o d y Ammo u t r a c e u t i c a l s , “ P r o d u c tA l e r t ” O c t . 2 7 , 1 9 9 7 .
R i c h a r d s o nL a b s , I n c . ,“ L o o k o u t N o n F o o d s E d i t i o n ) ”S e p .9 , 1 9 9 7 ) .
* c i t e d b y examiner
P r i m a r yExaminer—James O . W i l s o nA s s i s t a n t E x a m i n e r — D e v e s h Khare
7 4 ) A t t o r n e y, A g e n t , o r Firm—Richard C . L i t m a n
5 7 ) ABSTRACT
A u t r i t i o n a l c o m p o s i t i o nf o r t h e t r e a t m e n t o f c o n n e c t i v e
t i s s u e i n m a m m a l s Which i n c l u d e s a g l u c o s a m i n es a l t ,c h o n d r o i t i ns u l f a t e ,c o l l a g e n a n d s o d i u mh y a l u r o n a t eW h i c hs y n e r g i s t i c a l l y a c t a s a c h o n d r o p r o t e c t i v ea g e n t . The c o mp o s i t i o n c a n f u r t h e r i n c l u d e a d e t o x i f y i n g a g e n t , a n a n t i
i n ?ammato ry a g e n t o r a n a n a l g e s i c t o d e m o n s t r a t e a d d it i o n a lt h e r a p e u t i ca n d p h y s i o l o g i cp r o p e r t i e s .T h en u t r i t i o n ac o m p o s i t i o na c t s a s a c h o n d r o - p r o t e c t i v e a g e n tWhich p r ov i d e s f o u n d a t i o n a l s u p p o r t f o r t h e c r e a t i o n o f n e W bodyt i s s u ea n d c a r t i l a g eg r o W t hi n humans a n d a n i m a l s .
1 9 C l a i m s ,N o D r a w i n g s
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U S 6 , 6 4 5 , 9 4 8B 21
NUTRITIONAL COMPOSITION FOR THETREATMENT OF CONNECTIVE TISSUE
CROSS-REFERENCE TO RELATEDAPPLICATIONS
T h i s a p p l i c a t i o n i s a c o n t i n u a t i o n - i n - p a r t o f a p p l i c a t i o nS e r . N o . 0 9 / 3 6 0 , 1 6 9? l e d J u l .2 6 , 1 9 9 9 , n o w U S . P a t . N o .6 , 4 7 6 , 0 0 5 ,W h i c hi s a c o n t i n u a t i o n - i n - p a r to f a p p l i c a t i o nS e r .N o . 0 9 / 0 4 6 , 7 1 0? l e d M a r . 2 4 , 1 9 9 8 , a n d n o W a b a n d o n e d .
BACKGROUND OF THE INVENTION
1 . F i e l d o f t h e I n v e n t i o n
T h e p r e s e n t i n v e n t i o n r e l a t e st o t h e r a p e u t i c c o m p o s i t i o n sWhich p r o v i d e f o r t h e t r e a t m e n t o f c o n n e c t i v e t i s s u e i n
m a m m a l s a n d , more p a r t i c u l a r l y t o n u t r i t i o n a lc o m p o s i t i o n sc a p a b l e o f a c t i n g a s c h o n d r o p r o t e c t i v ea g e n t s , a s We l l a se x h i b i t i n ga d d e dp h a r m a c o l o g i c a lp r o p e r t i e s .
2 . D e s c r i p t i o no f t h e R e l a t e d A r t
The r e l a t e d a r t o f i n t e r e s t d i s c l o s e s n u m e r o u s p h a r m ac e u t i c a l c o m p o s i t i o n s a n dmethods f o r t h e t r e a t m e n t o fc o n n e c t i v et i s s u e i n humans a n d a n i m a l s . F o r e x a m p l e ,U S .P a t . N o . 4 , 8 3 7 , 0 2 4i s s u e d o n J u n . 6 , 1 9 8 9 , t o D o v M i c h a e l id e s c r i b e st o p i c a lc o m p o s i t i o n sf o ri m p r o v i n gW o u n dh e a l i n gc o m p r i s i n g a s u s p e n s i o n o f p a r t i c l e so f c o l l a g e n a n d ag l y c o s a m i n o g l y c a n .T h e c o m p o s i t i o ni s t a u g h t t o b e u s e f u lf o r t r e a t i n gs u r f a c e W o u n d sb y a p p l y i n gt h ec o m p o s i t i o nt oa g a u Z e , b a n d a g e o r t h e l i k e .
U S . P a t .N o . 4 , 2 1 6 , 2 0 4i s s u e d on A u g . 5 , 1 9 8 0 , a n d U S .P a t . N o . 4 , 4 5 5 , 3 0 2i s s u e d o n J u n . 1 9 , 1 9 8 4 , t o H a r r y J .R o b e r t s o nb o t h d i s c l o s e a m e d i c a lp r o t e i n h y d r o l y s a t e cont a i n i n g a n a c e t i c a c i d e x t r a c t o f p o l y p e p t i d e s a n d aminoa c i d s i n t h e f o r m o f poWder o r a g e l a n d p r o d u c e df r o mp o u l t r y f e e t .An queous s o l u t i o n c a n a l s o b e i n j e c t e d i n t o a
Wo u n d a r e a s u c h a s b u r n e da n i m a l r e g i o n s . The c o m p o s i t i o ni s d e s c r i b e da sb e i n g u s e f u l f o rr e g r o W i n gm u s c l e , s k i n a n dn e r v e t i s s u e .
U S . P a t .N o . 5 , 1 4 1 , 9 2 8 i s s u e d o n A u g . 2 5 , 1 9 9 2 , t oLaWrence G o l d m a n d e s c r i b e s o p h t h a l m i cm e d i c a t i o n scont a i n i n gg l y c o s a m i n o g l y c a np o l y s u l f a t e s ( G A G P S ) o r m u c op o l y s a c c h a r i d e sh a v i n g a m o l e c u l a rW e i g h ti n t h e r a n g e o f5 , 0 0 0 t o 2 0 , 0 0 0 D a l t o n s combined W i t h a n t i b i o t i c s f o rt r e a t i n g e y e i n f e c t i o n s a n d a n t i m i c r o b i a l a g e n t s s u c h a sp i l o c a r p i n e o r e p i n e p h r i n e f o r g l a u c o m a .G A G P Si n c l u d ec h o n d r o i t i n s u l f a t ea n d h y a l u r o n i c a c i d t h a tc o n t a i n h e xo s a m i n e s .
U S . P a t . N o . 5 , 8 4 0 , 7 1 5i s s u e d o n Nov. 2 4 , 1998 t o V i t oF l o r i o t e a c h e s a d i e t a r y r e g i m e no f n u t r i t i o n a ls u p p l e m e n t sf o r r e l i e fo f symptoms o f a r t h r i t i s .T h e d i e t a r y r e g i m e nc o m p r i s e sg a m m a i n o l e n i c a c i d (GLA), a m i x t u r eo f e i c o s ap e n t a e n o i c a c i d a n d d o c o s a h e x a n e o i ca c i d E P A ) a n d am i x t u r e o f c h o n d r o i t i n s u l f a t e ,g l u c o s a m i n es u l f a t ea n dm a n g a n e s ea s p a r a t e .
U S . P a t .N o . 5 , 4 4 2 , 0 5 3 i s s u e d o n A u g . 1 5 , 1 9 9 5 , t oF r a n c e s c o d e l l a Va l l e e t a l . d e s c r i b e s a p h a r m a c e u t i c a lc o m p o s i t i o na n d m e t h o df o r t r e a t i n go p h t h a l m i ca n d d e rm a t o l o g i c a lc o n d i t i o n s , d i s e a s e s o f t h e o r a la n d n a s a l c a v it i e s o r d i s e a s e s o f t h e o u t e r e a r b y a d m i n i s t e r i n g a s a l to f
h y a l u r o n i ca c i da l k a l i ,a l k a l im e t a l ,m a g n e s i u m ,a l u m i n u mo r a m m o n i u m ) combined W i t h a p h a r m a c o l o g i c a l l ya c t i v e
s u b s t a n c e s u c h a s e r y t h r o m y c i n .The h y a l u r o n i c a c i d f r a ct i o n h a s a n a v e r a g em o l e c u l a r W e i g h to f 3 0 , 0 0 0 t o 7 3 0 , 0 0 0 .The t o p i c a l m e d i c a m e n t can b e a p p l i e d a s s o l i d s o r i n
10
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35
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2W o u n d so f t h eb o d ys u r f a c e c o n t a i n i n gg l u c o s a m i n ea n d / o rN - a c e t y l g l u c o s a m i n ea n d g l u c o s a m i n e p h o s p h a t ei n a s a l i n es o l u t i o n
I t h a s f u r t h e rb e e n s u g g e s t e db y v a r i o u s p r i o r a r td i s c l os u r e s t o use e x c l u s i v e l y “ n u t r a c e u c e u t i c a l s ” o rcompos i t ions
c o n t a i n i n go n l yn a t u r a l l y - o c c u r r i n gc o m p o n e n t sf o r t r e a t i nc o n n e c t i v e t i s s u e a f f l i c t i o n s .F o r e x a m p l e ,U S . P a t .N o s .5 , 3 6 4 , 8 4 5 i s s u e d on N o v . 1 5 , 1 9 9 4 a n d 5 , 5 8 7 , 3 6 3 i s s u e dD e c . 2 4 , 1 9 9 6 , b o t h t o R o b e r t W . Henderson d e s c r i b et h e r a p e u t i cc o m p o s i t i o n sa d m i n i s t e r e di n c a p s u l e s f o r m f o rt h e p r o t e c t i o n, t r e a t m e n t a n d r e p a i r o f c o n n e c t i v e t i s s u ei nmammals . T h e c o m p o s i t i o n sc o n t a i n 2 5 0 — 3 0 0 0m g g l uc o s a m i n eh y d r o c h l o r i d eo r s u l f a t e ,50—1000 mg h o n d r o i t i ns u l f a t e ,a n d c a n a d d i t i o n a l l y c o m p r i s e1 5 — 9 5 0m g m a n g anese ascorba te .
I n o t h e r r e l a t e d a r t , B o d y Ammo N u t r a c e u t i c a l s i n a
“ P r o d u c tA l e r t ” a r t i c l e ,p u b l i s h e dO c t . 2 7 ,1 9 9 7 , d i s c l o s e sc a p s u l e s c o n t a i n i n gc u r c u m i n ,h y a l u r o n i ca c i d ,c h o n d r o i t is u l f a t ea n d g l u c o s a m i n e . T h i s p r o d u c ti s s t a t e dt o p r o v i d en u t r i t i o n a ls u p p o r t f o rc o n n e c t i v e t i s s u e .F u r t h e r , R i c h a r ds o n L a b s , I n c .i n a“ L o o k o u t(Non F o o d sE d i t i o n ) ” a b s t r a c t ,p u b l i s h e dS e p . 9 , 1 9 9 7 , d i s c l o s e s a p r o d u c t d e s c r i b e d a s af o o d s u p p l e m e n tc o n t a i n i n gh y d r o l y Z e dc o l l a g e n , g lcosamine a n d c h o n d r o t i ns u l f a t e t h a t i s d e s c r i b e d a s b e i n gc a p a b l e o fr e c o n s t r u c t i n gb o n e c a r t i l a g e .
U S . P a t . N o . 5 , 9 2 9 , 0 5 0i s s u e d o n u l . 2 7 , 1999 t o GeorgeD . P e t i t o d i s c l o s e s a method a n d c o m p o s i t i o nf o r t r e a t i n g
open Wo u n d s by a p p l y i n g t o t h e Wo u n d a n e f f e c t i v e a m o u n to f a n a q u e o u s s o l u t i o n o f c h r o n d r o i t i n s u l f a t e , Which m a yo p t i o n a l l yi n c l u d ec o l l a g e n ,s o d i u mh y a l u r o n a t ea n d / o rg l uc o s a m i n eh y d r o c h l o r i d e
W h i l e a l l t h e above r e f e r e n c e s have been d e s c r i b e s a s
b e i n g e f f e c t i v e f o r t h e i r i n t e n d e d u s e , t h e r e r e m a i n sa n e e di n t h e a r t f o r a t h e r a p e u t i c c o m p o s i t i o nWhich d e m o n s t r a t e senhanced e f f e c t i v e n e s s i n t h e t r e a t m e n t o f c o n n e c t i v et i s s u e s ,e x h i b i to t h e r i m p r o v e db e n e ? c i a l p r o p e r t i e s ,a n dp r o v i d e e v e n W i d e ra p p l i c a t i o n s i n t h e modes o f a d m i n i st r a t i o n .The p r e s e n t i n v e n t i o n m e e t s t h e s e n e e d s .
SUMMARY OF THE INVENTION
A c c o r d i n g l y ,i t i s a p r i n c i p a l o b j e c t o f t h ep r e s e n t i n v e nt i o nt o p r o v i d e t h e r a p e u t i c c o m p o s i t i o n st h a ta r en o t o n l yc a p a b l e o f e f f e c t i v e l y t r e a t i n gc o n n e c t i v e t i s s u e si nmammals , b u t d e m o n s t r a t e o t h e r b e n e ? c i a l p h y s i o l o g i c a lp r o p e r t i e s a s We l l .
I t i s a n o t h e r o b j e c t o f t h e p r e s e n t i n v e n t i o n t o p r o v i d en u t r i t i o n a l c o m p o s i t i o n sf o r t h e t r e a t m e n t o f c o n n e c t i v et i s s u e s i n h u m a n s and a n i m a l sW h i c h can be f o r m u l a t e di n t o
v a r i o u s p h a r m a c e u t i c a ld o s a g e f o r m s f o ro r a l ,t o p i c a la n dp a r e n t e r a la d m i n i s t r a t i o n .
I t a f u r t h e r o b j e c t o f t h e p r e s e n t i n v e n t i o n t o p r o v i d en u t r i t i o n a lc o m p o s i t i o n si n c l u d i n gc h o n d r o p r o t e c t i v ea g e n t sWhich p r o v i d e sf o u n d a t i o n a ls u p p o r t f o r t h e c r e a t i o n o f n e Wb o d y t i s s u ea n d c a r t i l a g eg r o W t hi n humans a n d a n i m a l s .
Ye t a n o t h e r o b j e c t o f t h e p r e s e n t i n v e n t i o n i s t o p r o v i d en u t r i t i o n a lc o m p o s i t i o n s f o r p r o m o t i n gt h e h e a l i n g o fWo u n d s i n humans a n d a n i m a l s , W h i l e r e d u c i n gt h e a s s o c ia t e d p a i n a n d i n ? a m m a t i o n .
T h e s e a n do t h e r o b j e c t s a r e a c c o m p l i s h e di n a c c o r d a n c e
W i t h t h ep r e s e n t i n v e n t i o n b y p r o v i d i n gn u t r i t i o n a lcompos i t i o n s c o m p r i s i n ga t h e r a p e u t i c a l l y e f f e c t i v e a m o u n t o f a
g l u c o s a m i n es a l t ,c h o n d r o i t i ns u l f a t e ,c o l l a g e n a n d s o d i u m
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U S 6 , 6 4 5 , 9 4 8B 23
t a b l e tf o r m f o r o r a l i n g e s t i o n . The p r e s e n t c o m p o s i t i o n sc a na l s o b e p r e p a r e d a s a g e l , p a s t e o r c r e a m f o r t o p i c a la p p l i c a t i o n , o r i n a s o l u t i o n o r s u i t a b l e p h a r m a c e u t i c a lc a r r i e r f o r o r a l o r p a r e n t e r a l a d m i n i s t r a t i o n. P r e f e r a b l y , a
d e t o x i f y i n g a g e n t , a n a n t i - i n ? a m m a t o r ya g e n t a n d / o r a n
a n a l g e s i c i s i n c o r p o r a t e di n t ot h e f o r m u l a t i o n s t o p r o v i d ea d d e db e n e ? c i a l t h e r a p e u t i c a n d p h y s i o l o g i cp r o p e r t i e s t ot h ep r e s e n tc o m p o s i t i o n s .
DETAILED DESCRIPTION OF THEPREFERRED EMBODIMENTS
The p r e s e n t i n v e n t i o n p r o v i d e s a nimprovement o v e r t h ec o m p o s i t i o n ss e t f o r t h i nt h e a f o r e m e n t i o n e da p p l i c a t i o nS e r .N o . 0 9 / 3 6 0 , 1 6 9? l e d J u l . 2 6 , 1 9 9 9 , t h e d i s c l o s u r e o fW h i c hi s i n c o r p o r a t e d h e r e i nb y r e f e r e n c e i n i t s e n t i r e t y .T h u s , t h e p r e s e n t i n v e n t i o n i s d i r e c t e d t o a n u t r i t i o n a l
c o m p o s i t i o nc o m p r i s i n ga t h e r a p e u t i c a l l y e f f e c t i v ea m o u n to f a c h o n d r o p r o t e c t i v ea g e n t , p r e f e r a b l y i n c o m b i n a t i o nW i t h a t l ea s t o n e o t h e r p h y s i o l o g i c a l l yb e n e ? c i a l a g e n t . Thep r e s e n t
n u t r i t i o n a lc o m p o s i t i o n c o m p r i s e sa b o u t 1 — 3 0
mg/kg o f a g l u c o s a m i n es a l t , a b o u t 1 — 1 5mg/kg o f c h o nd r o i t i ns u l f a t e ,a b o u t 1 — 3 0m g / k go f c o l l a g e n a n d a b o u t1 — 1 5m g / k go f s o d i u mh y a l u r o n a t eW h i c hs y n e r g i s t i c a l l ya c ta s t h e c h o n d r o p r o t e c t i v ea g e n t , W h e r e i nt h e d o s a g e o f e a c hs o l i dc o m p o n e n tp r e s e n t i n t h e c o m p o s i t i o ni s e x p r e s s e dh e r e i n i n t e r m s o f mg e r k g b o d y W e i g h to f t h e h u m a n o b et r e a t e d .T h e u n i td o s a g e s o f t h ep r e s e n t c o m p o s i t i o n sf o ra n i m a l s may b e s u b s t a n t i a l l yl a r g e r .
W h i l et h ep r e s e n tc o m p o s i t i o n se f f e c t i v e l yp r o v i d e f o u nd a t i o n a l s u p p o r t f o r t h e c r e a t i o n o f n e W body t i s s u e a n dc a r t i l a g eg r o W t h ,f a c i l i t a t ec h o n d r o c y t es y n t h e s i s ,p r o t e c ta n d m a i n t a i nh e a l t h y m u s c l ea n d t i s s u e ,i n c r e a s e h y a l u r o n i ca c i d c o n c e n t r a t i o n s , a n d r e d u c e i n ? a m m a t i o n ,o t h e r b e n e ?
c i a lp h y s i o l o g i c a l p r o p e r t i e s o f t h e c o m p o s i t i o n sc a n b es i g n i ? c a n t l y e n h a n c e db y t h e i n c o r p o r a t i o n o f a d d i t i o n a lc h e m i c a la g e n t s . P r e f e r a b l y , a d e t o x i f y i n g a g e n t , a n a n t iin?ammatory a g e n t a n d / o r a n a n a l g e s i c i s a d d e d t o t h ep r e s e n t n u t r i t i o n a lc o m p o s i t i o n s f o r t h e s e i n t e n d e d p u rp o s e s .
T h e g l u c o s a m i n es a l tc o m p o n e n to f t h ep r e s e n t c o m p os i t i o n si s p r e f e r a b l yt h eh y d r o c h l o r i d es a l t ,b u t o t h e r s a l t so fg l u c o s a m i n e s u c ha s t h e s u l f a t e , n i t r a t e o r i o d i d e o b t a i n e df r o m e i t h e r s y n t h e t i c , bovine o r p o r c i n e s o u r c e s a r e a l s os u i t a b l e .The c h o n d r o i t i n s u l f a t e component m a y i n c l u d e
Ty p e A c h o n d r o i t i n - 4 - s u l f a t e ) ,Ty p e B c h r o n d r o i t i n - 5s u l f a t e ) ,a n d / o rTy p e C c h o n d r o i t i n - 6 - s u l f a t e ) ,o b t a i n e dt h r o u g hf e r m e n t a t i o no r e x t r a c t i o n o f b o v i n e t r a c h e a , o t h e r
b o v i n e o r p o r c i n e s o u r c e s . A o l e c u l a r W e i g h t r a n g e o f2 , 0 0 0 — 5 0 , 0 0 0 c a n b eu s e d , W i t h a p r e f e r r e d r a n g e o f2 5 , 0 0 0 — 3 5 , 0 0 0 .T h e s o d i u mh y a l u r o n a t ec o m p o n e n to f t h ep r e s e n t c o m p o s i t i o n s a r e o b t a i n e d f r o m e i t h e rs y n t h e t i c ,bovine o r a v i a n s o u r c e sWi th a molecu la r We i g h t r ange f r o ma b o u t 5 0 , 0 0 0 t o a b o u t 3 , 5 0 0 , 0 0 0D a l t o n s . B o t h t h e c h r o nd r o i t i n s u l f a t e a n d sodium h y a l u r o n a t e components a r e
g l y c o s a m i n o g l y c a n s ,commonly k n o W n a s m u c o p o l y s a cc h a r i d e s .
A l l t y p e s o f c o l l a g e n , i n c l u d i n g n a t i v e a s We l l a s h y d r ol y Z e d c o l l a g e n , o b t a i n e d f r o m s y n t h e t i c ,a v i a n ,b o v i n e o rp o r c i n e s o u r c e sWo u l d b e s u i t a b l e a s t h e c o l l a g e n c o m p on e n t o f t h ep r e s e n t c o m p o s i t i o n s .T h e h y d r o l y Z e dc o l l a g e nc o m p o n e n tc a n i n c l u d e h y d r o l y Z e dT y p e 1 c o l l a g e n ,p r e f
e r a b l yn a t u r a lh y d r o l y Z e dc o l l a g e n p o W d e rh a v i n g a p H o f5 . 5 — 6 . 5 ,a n a s h c o n t e n t o f 2 .5 m a x i m u m , a n i s o t o n i c p o i n to f 5 . 0 — 6 . 5 .The h y d r o l y Z e dType 1 c o l l a g e n c a n h a v e a
10
1 5
20
25
30
35
40
45
50
55
60
4i n c l u d e a manganese s a l ta n d L - m a l i ca c i d . Apreferred s a l ti s manganese a s c o r b a t e b e c a u s ei t p r o v i d e sa s c o r b i ca c i d f o rc o l l a g e n s y n t h e s i s , b u t o t h e r manganese s a l t ss u c h a s t h es u l f a t e ,n i t r a t e ,a n d g l u c o n a t e c a n b e u s e d . The L - m a l i ca c i da c t s a s ad e t o x i f y i n g a g e n tby r i d d i n g t h e body o f u n W a n t e d
l a c t i ca c i d ,o f t e n f o u n d i n c o n n e c t i v e t i s s u e .B o t h t h eL - m a l i c a c i d and manganese s a l t a r e p r e f e r a b l y o f U . S . P.f o o d g r a d e , a n d a r e p r e s e n t i n t h e n u t r i t i o n a l c o m p o s i t i o n so f t h ep r e s e n t i n v e n t i o ni n d o s a g e sr a n g i n gf r o m a b o u t 0 . 0 5t o a b o u t 8 m g / k g .
P h a r m a c o l o g i c a la g e n t s m a y b e i n c o r p o r a t e d i n t ot h en u t r i t i o n a lc o m p o s i t i o n so f t h e p r e s e n t i n v e n t i o n t o s i g n i ?c a n t l y e n h a n c e t h ep h y s i o l o g i c a lp r o p e r t i e s o f t h ecompos i t i o n s .T h e a n t i - i n ? a m m a t o r ya g e n t s m e t h ys u l f o n y lm e t ha n e ( M S M ) a n d c e t y l m y r i s t o l e a t em a y b e a d d e d t o r e d u c ea n i n ?ammato ry r e s p o n s e . The MSM m a y b e added i n
a m o u n t so f a b o u t 0 . 5 — 4 0m g / k g ,a n d c e t y lm y r i s t o l e a t e i na m o u n t s o f 1 — 1 0 5m g / k g . T h e p r e s e n t c o m p o s i t i o n sm a ya l s o b e c o m b i n e dW i t h a s p i r i n ,p r e f e r a b l y i n t h e r a n g e o fa b o u t 0 . 1 — 3 5m g / k g , a n do t h e r c o m m e r c i a l l ya v a i l a b l e a n a lg e s i c s t o r e d u c ep a i n .I n a d d i t i o n , t h ei n c o r p o r a t i o n o fs u c hv i t a m i n sa sV i t a m i nC a s c o r b i ca c i d ) a n d V i t a m i n B 1 2i n t h ep r e s e n t c o m p o s i t i o n sp r o v i d e s a d d e d b e n e ? t s t o s o f ta n dh a r d t i s s u e s .
The n u t r i t i o n a l c o m p o s i t i o n so f t h e p r e s e n t i n v e n t i o n a r e
f o r m u l a t e d i n t o p o W d e r ,c a p s u l e o r t a b l e tf o r m f o r o r a li n g e s t i o n ,A l s o , t h e p r e s e n t c o m p o s i t i o n sa r e c a p a b l e o fb e i n g combined W i t h a s u i t a b l e p h a r m a c e u t i c a lc a r r i e ra n dp r e p a r e d a s a g e l ,p a s t e o r c r eam f o r t o p i c a l a p p l i c a t i o n .A l t e r n a t i v e l y , t h e c o m p o s i t i o n s c a nb e f o r m u l a t e d i n a
s o l u t i o n o r s u i t a b l e pharmaceu t ica l d i l u e n t f o r o r a l a s W e l l a s
p a r e n t e r a la d m i n i s t r a t i o n .F o r p a r e n t e r a la d m i n i s t r a t i o n ,t h ep r e s e n tc o m p o s i t i o n s
a r e p r e f e r a b l y d i s s o l v e di n s t e r i l i Z e d W a t e r and b u f f e r e dW i t hsuch b u f f e r i n g a g e n t s a s c i t r i ca c i d o r s o d i u m c h l o r i d e t o
i m p r o v es h e l f l i f e .The p H o f t h e p r e s e n t s o l u t i o n s c a n b ea d j u s t e dW i t h c o n v e n t i o n a la g e n t s .A l s o , p r e s e r v a t i v e ss u c ha se t h y l e n e - d i a m i n e t e t r a a c e t i c a c i dE D T A ) ,b e n Z y la l c o h o l ,and b e n Z a l k o n i u m c h l o r i d e can be a d d e d .
The n u t r i t i o n a lc o m p o s i t i o n so f t h e p r e s e n t i n v e n t i o np r o v i d ea n e n h a n c e dc h o n d r o p r o t e c t i v ee f f e c tb y p r o v i d i n gf o u n d a t i o n a ls u p p o r t f o r t h e c r e a t i o n o f n e Wbody t i s s u e a n dc a r t i l a g eg r o W t hi n m a m m a l s . T h ec o l l a g e n c o m p o n e n ta c t sa s a t r a n s p o r t e r o r c a r r i e r f o r t h e l a r g e r molecu les o f s o d i u mh y a l u r o n a t e a n d / o r c h o n d r o i t i n s u l f a t eb y a i d i n g i n t h ea b s o r p t i o np r o c e s so f t h e s el a r g em o l e c u l e s ,t h e r e b yi n c r e a si n g t h eb i o - a v a i l a b i l i t yo f t h e s e t h e r a p e u t i c e f f e c t i v ec o m
p o n e n t s .I t i s t o b e u n d e r s t o o dt h a t t h e p r e s e n t i n v e n t i o n i s n o t
l i m i t e d t o t h e e m b o d i m e n t s d e s c r i b e d a b o v e , b u te n c o mp a s s e s any and a l l embod imen t s W i t h i n t h e s c o p e o f t h ef o l l o W i n gc l a i m s .
We l a i m :
1 . u t r i t i o n a l c o m p o s i t i o nf o r t h e t r e a t m e n t o f connect i v et i s s u e i n m a m m a l s c o m p r i s i n g :a t h e r a p e u t i c a l l y e f f e ct i v e amoun t o f a g l u c o s a m i n es a l t , c h o n d r o i t i n s u l f a t e ,c o l l a g e n a n d s o d i u mh y a l u r o n a t e .
2 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i n g t o c l a i m 1 ,W h e r e i n t h e g l u c o s a m i n es a l t i s s e l e c t e d f r o m t h e g r o u pc o n s i s t i n go f g l u c o s a m i n eh y d r o c h l o r i d e ,g l u c o s a m i n es u l f a t e ,g l u c o s a m i n en i t r a t ea n d g l u c o s a m i n ei o d i d e .
3 3 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i n g t o c l a i m 1 ,W h e r e i nt h ec o l l a g e n i s h y d r o l y Z e dc o l l a g e n .
4 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i n g t o c l a i m 3 ,
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U S 6 , 6 4 5 , 9 4 8B 25
5 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i mf u r t h e r c o m p r i s i n ga mang ane se s a l t .
6 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i ngt o c l a i mWherein t h e man ganese s a l ti s manganese a s c o r b a t e .
7 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m
f u r t h e rc o m p r i s i n ga d e t o x i f y i n g a g e n t .8 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i ngt o c l a i m
W h e r e i nt h e d e t o x i f y i n g a g e n t i s L - m a l i ca c i d .9 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m
f u r t h e rc o m p r i s i n g a n a n t i - i n ? a m m a t o r ya g e n t .1 0 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m
W h e r e i nt h e a n a n t i - i n ? a m m a t o r ya g e n t i s s e l e c t e d f r o m t h eg r o u pc o n s i s t i n go f m e t h ys u l f o n y lm e t h a n ea n d c e t y lm y r i st o l e a t e .
1 1 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m 1 ,f u r t h e r c o m p r i s i n ga n a n a l g e s i c .
1 2 .T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m 1 1 ,W h e r e i nt h ea n a l g e s i c i s a s p i r i n .
1 3 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m 1 ,f u r t h e r comprising a v i t a m i n s e l e c t e d f r o m t h e group c o ns i s t i n go f V i t a m i nC a n d V i t a m i nB 1 2 .
1 4 . T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m 1 ,W h e r e i nt h e c o m p o s i t i o ni s f o r m u l a t e di n t o a u n i t d o s a g efo rm f o r o r a l a d m i n i s t r a t i o n .
1 ,
10
1 5
20
61 5 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i n g t o c l a i m 1 ,
W h e r e i nt h e c o m p o s i t i o ni s combined W i t h a s u i t a b l e p h a rm a c e u t i c a lc a r r i e r and p r e p a r e d a s a g e l , p a s t e o r c r e a m f o r
t o p i c a l a p p l i c a t i o n .1 6 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i n g t o c l a i m 1 ,
Where in t h e composit ion i s f o r m u l a t e d i n a s o l u t i o n o rs u i t a b l e p h a r m a c e u t i c a ld i l u e n t f o r o r a l o r p a r e n te r a l admini s t r a t i o n .
1 7 . T h e n u t r i t i o n a lc o m p o s i t i o n a c c o r d i n g t o c l a i m 1 ,W h e r e i n t h e c o m p o s i t i o n c o m p r i s e s , b a s e d o n mg/kg o fb o d y We i g h t :
a b o u t 1 — 3 0mg/kg o f a g l u c o s a m i n es a l t ;a b o u t 1 — 1 5m g / k go f c h o n d r o i t i ns u l f a t e ;a b o u t 1 — 3 0m g / k go f c o l l a g e n ; a n d
a b o u t 1 — 1 5m g / k go f s o d i u mh y a l u r o n a t e .1 8 .T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m 1 7 ,
f u r t h e r i n c l u d i n ga manganese s a l tr a n g i n g f r o m a b o u t 0 . 0 5t o a b o u t 8 m g / k g .
1 9 .T h e n u t r i t i o n a lc o m p o s i t i o na c c o r d i n g t o c l a i m 1 7 ,f u r t h e r i n c l u d i n g L - m a l i ca c i d r a n g i n g f r o m a b o u t 0 . 0 5 t oa b o u t 8 m g / k g .
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“EXHIBIT B”
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/22/13droitin Formula -- 80 Coated Caplets - V…
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Nature's Bounty Flex-a-minSuper Glucosamine 2000 Plus
-- 60 Coated Tablets
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Chondroitin MSM w ith 5-LoxinAdvanced™ -- 75 Coated
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Short Description
• With Bone Shield• Plus Vitamins K2 and D3• Shows Improvement In Joint Comfort within 7 Days!• Helps Lubricate Joints• Helps Maintain Bone mass and Strength• Easy to Swallow Coated Caplets - 2 Caplets Per Day!
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Nature's Bounty Flex-a-min® Triple Strength Glucosamine Chondroitin Formula -- 80 CoatedCaplets
Vitamins & Supplements Glucosamine & Chondroitin Glucosamine & Chondroitin
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Item #: NTY 6148461SKU #: 699866148461Count: 80 Ca pletsWeight: 0.52Serving: 2 CapletsServings: 4 0
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Nature's Bounty Flex-a-min® Triple Strength Glucosamine Chondroitin Formula Directions
For adults, take two (2) caplets daily, preferably with a meal. Take this product with plenty of fluids. For best results, take this product with plenty of fluids. For best results, take the full dosage of Flex-a-min® daily.
Product Re vie ws Product De tails Supplement Facts Email To A Friend
Supplement FactsServing Size: 2 CapletsServings per Container: 40
Am ount Pe r Se rving % Daily Value
Calories 10Total Carbohydrate 2 g 1%
Vitamin C (as Ascorbic Acid) 200 mg 333%
Vitamin D (as D3 Cholecalciferol) 1000 IU 250%
Vitamin K2 (as Menaquinone) 20 mcg 25%
Calcium (as Calcium Carbonate) 200 mg 20%
Sodium 25 mg 1%
Glucosamine HCl (1.5g) 1500 mg
Bone Shield Proprietary Blend (1.14g) 1140 mg
Chondroitin Sulfate MSM Complex (1 g)(Chondroitin Sulfate, MSM (Methylsulfonylmethane), Vitamin C,collagen (Hydrolyzed Gelatin), Calcium, Vitamin D, Vitamin K2)
1000 mg
Hyaluronic Acid Blend(as Calcium Silicate and Sodium Hyaluronate)
40 mg
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Copyright © 2013 Vitacost.com. All rights reserved • Designated trademarks and brands are the property of their respective owners.The products and the claims made about specif ic products on or through this site have not been evaluated by Vitacost.com or the United States Food and Drug Administration and are not approv ed to diagnose, treat,cure or prevent disease. The information provided on this site is f or informational purposes only and is not intended as a substitute for adv ice from y our physician or other health care professional or any informationcontained on or in any product label or packaging. You should not use the inf ormation on this site f or diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You s houldconsult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if y ou have or suspect you m ight have a health problem.Not responsible for t ypographical errors or misprints. Product av ailability , pricing, and promotions are subject to c hange without notice.
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Other Ingredients: Vegetable cellulose, povidone. Contains <2% of: natural caram el color, titanium dioxide color,vegetable magnesium stearate.
Contains milk, soy and shellfish (shrimp, crab, lobster, crayfish) ingredients.
If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use.Discontinue use and consult your doctor if any adverse reactions occur. Not intended for use by persons under theage of 18.
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Case 1:13-cv-08077-CM Document 1 Filed 11/13/13 Page 14 of 16
8/14/2019 Petito et. al. v. Nature's Bounty
http://slidepdf.com/reader/full/petito-et-al-v-natures-bounty 15/16
“EXHIBIT C”
Case 1:13-cv-08077-CM Document 1 Filed 11/13/13 Page 15 of 16
8/14/2019 Petito et. al. v. Nature's Bounty
http://slidepdf.com/reader/full/petito-et-al-v-natures-bounty 16/16