petito et. al. v. rexall sundown
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EXHIBIT A
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1 2 ) United S t a t e s PatentP e t i t o e t a l .
US006645948B2US 6 , 6 4 5 , 9 4 8 B2
* N o v . 1 1 , 2 0 0 31 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 )
6 3 )
5 1 )5 2 )5 8 )5 6 )
1 , 9 5 0 , 1 0 0 A4 , 0 0 6 , 2 2 4 A4 , 2 1 6 , 2 0 4 A
NUTRITIONAL COMPOSITION FOR THETREATMENT OF CONNECTIVE TISSUEI n v e n t o r s : George D . P e t i t o , 1 8 9 0 B u c k n e l l D r . ,
B e t h l e h e m , PA U S ) 1 8 0 1 5 ; A n i t a M.P e t i t o , 1 8 9 0 B u c k n e l l D r . , B e t h l e h e m ,P A U S ) 1 8 0 1 5N 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 s
p 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 DataUS 2 0 0 3 / 0 0 6 9 1 7 1 A1 A p r . 1 0 , 2 0 0 3
R e l a t e d US. A p p l i c a t i o n DataC 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 n N o . 0 9 / 3 6 0 , 1 6 9 , ? l e d o nJ u l . 2 6 , 1 9 9 9 , n ow 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 d o n M a r .2 4 , 1 9 9 8 , now 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 earch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 514/62, 2 , 5 4 ;
4 2 4 / 4 4 9R e f e r e n c e s C i t e d
U . S . PATENT DOCUMENTS3 / 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 Goldman5 , 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 V a l l e e t a l .5 , 4 9 8 , 6 0 6 A 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 o6,476,005 B1 * 11/2002 P e t i t o e t a l . . . . . . . . . . . . . . . . . . . 514/62
FOREIGN PATENT DOCUMENTSDE 3445324 1 2 / 1 9 8 6F R 2035781 1 2 / 1 9 7 0GB 896940 5 / 1 9 6 2
OTHER PUBLICATIONSBody Ammo u t r a c e u t i c a l s , P r o d u c t A l e r t O c t . 2 7 , 1 9 9 7 .R i c h a r d s o n L 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 by examinerP r i m a r y ExaminerJames O . W i l s o nA s s i s t a n t ExaminerDevesh Khare7 4 ) A t t o r n e y , A g e n t , o r FirmRichard C . L i t m a n5 7 ) ABSTRACTA u t r i t i o n a l c o m p o s i t i o n 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 mamma ls Which i n c l u d e s a g l u c o s a m i n e s 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 m h y a l u r o n a t e W 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 e a 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 iin?ammatory 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 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 c p r o p e r t i e s . 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 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 t Which 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 e a n d c a r t i l a g e g r o W t h i n humans a n d a n i m a l s .
1 9 C l a i m s , No D r a w i n g s
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US 6 , 6 4 5 , 9 4 8 B21
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 , now US. P a t . N o .6 , 4 7 6 , 0 0 5 , W h i c h 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 n S 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 INVENTION1 . F i e l d o f t h e I n v e n t i o nT h e p r e s e n t i n v e n t i o n r e l a t e s t o t h e r a p e u t i c c o m p o s i t i o n s
Which 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 nmamma ls 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 l c 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 e a g e n t s , a s W e l l a se x h i b i t i n g a d d e d p h a r m a c o l o g i c a l p r o p e r t i e s .
2 . D e s c r i p t i o n o f t h e R e l a t e d A r tThe 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 numerous pharma
c e u t i c a l c o m p o s i t i o n s a n d methods 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 e t 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 , US.P a t . N o . 4 , 8 3 7 , 0 2 4 i s s u e d on 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 s t o p i c a l c o m p o s i t i o n s f o r i m p r o v i n g W o u n d h 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 s o 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 n i 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 g s u r f a c e W o u n d s b y a p p l y i n g t h e c o m p o s i t i o n t oa g a u Z e , bandage o r t h e l i k e .
US. P a t . N o . 4 , 2 1 6 , 2 0 4 i s s u e d on A u g . 5 , 1 9 8 0 , a n d US.P a t . N o . 4 , 4 5 5 , 3 0 2 i 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 n b o t h d i s c l o s e a m e d i c a l p 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 d f 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 aW o u nd a r e a s u c h a s b u r n e d a 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 d a s b e i n g u s e f u l f o r r e g r o W i n g m u s c l e , s k i n a n dnerve t i s s u e .
US. 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 dman d e s c r i b e s o p h t h a l m i c m e d i c a t i o n s cont a i n i n g g l y c o s a m i n o g l y c a n p o l y s u l f a t e s (GAGPS) o r mucop o l y s a c c h a r i d e s h a v i n g a m o l e c u l a r W e i g h t i 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 S i n c l u d ec h o n d r o i t i n s u l f a t e a n d h y a l u r o n i c a c i d t h a t c o n t a i n h e xo s a m i n e s .
U S . P a t . No. 5 , 8 4 0 , 7 1 5 i 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 n o f n u t r i t i o n a l s u p p l e m e n t s
10
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2W o u n d s o f t h e b o d y s u r f a c e c o n t a i n i n g g l u c o s a m i n e a n d / o rN - a c e t y l g l u c o s a m i n e a n d g l u c o s a m i n e p h o s p h a t e i 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 r b e e n s u g g e s t e d b y v a r i o u s p r i o r a r t d 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 r compositionsc o n t a i n i n g o n l y n a t u r a l l y - o c c u r r i n g c o m p o n e n t s f o r t r e a t i n gc 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 , US. 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 c c o m p o s i t i o n s a d m i n i s t e r e d i 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 e i nmammals. T h e c o m p o s i t i o n s c o n t a i n 2 5 0 3 0 0 0 m g g l uc o s a m i n e h y d r o c h l o r i d e o r s u l f a t e , 501000 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 e 1 5 9 5 0 m g manganese ascorbate.
I n o t h e r r e l a t e d a r t , Body Ammo N u t r a c e u t i c a l s i n a P r o d u c t A l e r t a r t i c l e , p u b l i s h e d O 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 g c u r c u m i n , h y a l u r o n i c a c i d , c h o n d r o i t i ns u l f a t e a n d g l u c o s a m i n e . T h i s p r o d u c t i s s t a t e d t o p r o v i d en u t r i t i o n a l s u p p o r t f o r c 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 s E d i t i o n ) a b s t r a c t ,p u b l i s h e d S 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 t c o n t a i n i n g h y d r o l y Z e d c o l l a g e n , g l ucosamine a n d c h o n d r o t i n s 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 f r e c o n s t r u c t i n g b 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 0 i s s u e d on 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 n f o r t r e a t i n gopen W o unds by a p p l y i n g t o t h e W o u n d a n e f f e c t i v e amounto f a n aqueous 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 y i n c l u d e c o l l a g e n , s o d i u m h y a l u r o n a t e a n d / o r g l uc o s a m i n e h y d r o c h l o r i d eWhile 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 sb 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 s a 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 n Which 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 t o t h e r i m p r o v e d b 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 r a 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 INVENTIONA 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 e p r e s e n t i n v e nt i o n t 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 s t h a t a r e n o t o n l y
c 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 g c o n n e c t i v e t i s s u e s i 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 W e 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 s 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
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t a b l e t f 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 s c 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 cream 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 , ad 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 y a g e n t a n d / o r a na n a l g e s i c i s i n c o r p o r a t e d i n t o t 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 d b 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 c p r o p e r t i e s t ot h e p r e s e n t c 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 n improvement o v e r t h ec o m p o s i t i o n s s e t f o r t h i n t h e a f o r e m e n t i o n e d 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 , t h e d i s c l o s u r e o fW h i c h i s i n c o r p o r a t e d h e r e i n b 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 lc o m p o s i t i o n 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 c t i v e a m o u n to f a c h o n d r o p r o t e c t i v e a 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 e a s t o n e o t h e r p h y s i o l o g i c a l l y b 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 l c o m p o s i t i o n c o m p r i s e s a b o u t 1 3 0mg/kg o f a g l u c o s a m i n e s a l t , a b o u t 1 1 5 mg/kg o f c h o nd r o i t i n s u l f a t e , a b o u t 1 3 0 m g / k g o f c o l l a g e n a n d a b o u t1 1 5 m g / k g o f s o d i u m h y a l u r o n a t e W h i c h s y n e r g i s t i c a l l y a c ta s t h e c h o n d r o p r o t e c t i v e a g e n t , W h e r e i n t h e d o s a g e o f e a c hs o l i d c o m p o n e n t p r e s e n t i n t h e c o m p o s i t i o n i 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 kg b o d y W e i g h t o f t h e h uman o b et r e a t e d . T h e u n i t d o s a g e s o f t h e p r e s e n t c o m p o s i t i o n s f o ra n i m a l s may b e s u b s t a n t i a l l y l a r g e r .
W h i l e t h e p r e s e n t c o m p o s i t i o n s e f f e c t i v e l y p 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 neW body t i s s u e a n dc a r t i l a g e g r o W t h , f a c i l i t a t e c h o n d r o c y t e s y n t h e s i s , p r o t e c ta n d m a i n t a i n h e a l t h y m u s c l e a 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 l p 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 s c a n b es i g n i ? c a n t l y e n h a n c e d b 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 l a 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 l c 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 e s a l t c o m p o n e n t o f t h e p r e s e n t compos i t i o n s i s p r e f e r a b l y t h e h y d r o c h l o r i d e s a l t , b u t o t h e r s a l t s o fg l u c o s a m i n e s u c h a 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 dfrom 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 may i n c l u d eT y p e A c h o n d r o i t i n - 4 - s u l f a t e ) , T y 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 r T y 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 h f e r m e n t a t i o n o 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 rb 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 e u s e d , W i t h a p r e f e r r e d r a n g e o f
10
1 5
20
25
30
35
40
45
4i n c l u d e a manganese s a l t a n d L - m a l i c a 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 e i t p r o v i d e s a s c o r b i c a 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 s s 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 c a c i da c t s a s a d e t o x i f y i n g a g e n t by r i d d i n g t h e body o f u n W a n t e dl a c t i c a 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 e p r e s e n t i n v e n t i o n i n d o s a g e s r 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 .
P h a r m a c o l o g i c a l a g e n t s may b e i n c o r p o r a t e d i n t o t h en u t r i t i o n a l c o m p o s i t i o n s o 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 e p 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 compos i t i o n s . T h e a n t i - i n ? a m m a t o r y a g e n t s m e t h y s u l f o n y l m e t ha n e ( M SM ) a n d c e t y l m y r i s t o l e a t e may b e a d d e d t o r e d u c ea n in?ammatory r e s p o n s e . The MSM m a y b e added i na m o u n t s o f a b o u t 0 . 5 4 0 m g / k g , a n d c e t y l m y r i s t o l e a t e i na m o u n t s o f 1 1 0 5 m g / k g . T h e p r e s e n t c o m p o s i t i o n s maya l s o b e c o m b i n e d W 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 5 m g / k g , a n d o t h e r c o m m e r c i a l l y a v a i l a b l e a n a lg e s i c s t o r e d u c e p a i n . I n a d d i t i o n , t h e i n c o r p o r a t i o n o f s u c hv i t a m i n s a s V i t a m i n C a s c o r b i c a c i d ) a n d V i t a m i n B 1 2 i n t h ep r e s e n t c o m p o s i t i o n s p r o v i d e s a d d e d b e n e ? t s t o s o f t a 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 s o f t h e p r e s e n t i n v e n t i o n a r ef 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 t f 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 s a 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 l c a r r i e r a n dp r e p a r e d a s a g e l , p a s t e o r cream 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 n b e f o r m u l a t e d i n as o l u t i o n o r s u i t a b l e pharmaceutical d i l u e n t f o r o r a l a s W e l l a sp a r e n t e r a l a 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 l a d m i n i s t r a t i o n , t h e p r e s e n t c o m p o s i t i o n sa r e p r e f e r a b l y d i s s o l v e d i n s t e r i l i Z e d W a t e r and b u f f e r e d W 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 c a c i d o r sodium c h l o r i d e t oi m p r o v e s 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 d W i t h c o n v e n t i o n a l a g e n t s . A l s o , p r e s e r v a t i v e s s u c ha s e 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 d E D T A ) , b e n Z y l a l c o h o l ,and benZalkonium 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 l c o m p o s i t i o n s o 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 e a n e n h a n c e d c h o n d r o p r o t e c t i v e e f f e c t b y p r o v i d i n gf 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 body t i s s u e a n dc a r t i l a g e g r o W t h i n m a m m a l s . T h e c o l l a g e n c o m p o n e n t a 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 molecules o f sodiumh 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 e b y a i d i n g i n t h ea b s o r p t i o n p r o c e s s o f t h e s e l a r g e m o l e c u l e s , t h e r e b y i n c r e a si n g t h e b i o - a v a i l a b i l i t y o 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 e comp o n e n t s .
I t i s t o b e u n d e r s t o o d t 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
Case 1:13-cv-08074-PKC Document 1 Filed 11/13/13 Page 9 of 18
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US 6 , 6 4 5 , 9 4 8 B25
5 . 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 a 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 g a manganese s a l t .6 . 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 a c c o r d i ng t o c l a i mWherein t h e manganese s a l t i 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 l c 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 mf u r t h e r c o m p r i s i n g a 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 l c o m p o s i t i o n a c c o r d i ng t o c l a i mW h e r e i n t 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 c a c i d .9 . 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 a 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 g a n a n t i - i n ? a m m a t o r y a g e n t .1 0 . 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 a c c o r d i n g t o c l a i mW h e r e i n t h e a n a n t i - i n ? a m m a t o r y a g e n t i s s e l e c t e d f r o m t h eg r o u p c o n s i s t i n g o f m e t h y s u l f o n y l m e t h a n e a n d c e t y l m 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 l c 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 ,f u r t h e r c o m p r i s i n g a 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 l c 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 1 ,W h e r e i n t h e a 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 l c 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 ,f u r t h e r comprising a v i t a m i n s e l e c t e d from t h e group cons i s t i n g o f V i t a m i n C a n d V i t a m i n B 1 2 .
1 4 . 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 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 i s f o r m u l a t e d i n t o a u n i t d o s a g eform 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 l c 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 i 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 l c 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 cream f o rt 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 l c 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 ,Wherein t h e composition 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 l d 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 l c 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 W e i g h t :
a b o u t 1 3 0 mg/kg o f a g l u c o s a m i n e s a l t ;a b o u t 1 1 5 m g / k g o f c h o n d r o i t i n s u l f a t e ;a b o u t 1 3 0 m g / k g o f c o l l a g e n ; a n da b o u t 1 1 5 m g / k g o f s o d i u m h 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 l c 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 7 ,
f u r t h e r i n c l u d i n g a manganese s a l t r 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 l c 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 7 ,f u r t h e r i n c l u d i n g L - m a l i c a 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 .
Case 1:13-cv-08074-PKC Document 1 Filed 11/13/13 Page 10 of 18
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EXHIBIT B
Case 1:13-cv-08074-PKC Document 1 Filed 11/13/13 Page 11 of 18
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8/13/2019 Petito et. al. v. Rexall Sundown
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Part No. 22-67986
44967 07G B18617 LAB
2012
60POINTS
60POINTS
For more information visitwww.osteobiflex.com
FnL1010020
01BE5CVFkETkJUWQBEGre6
30768 034520 8
Osteo Bi-FlexMSM Formula caplets are apotent combination of highly effectiveingredients in Joint Care Science and theonly leading brand containing Joint Shieldwith 5-LOXINAdvanced.
See Bottom of Package for our
Ambassadors Clubrewards points program.
*These statements have not been evaluated by the Food and DrugAdministration. This product is not intended to diagnose, treat, cure orprevent any disease.
Osteo Bi-Flexis manufactured underthe highest standards for product
quality, purity and potency.
To learn more about Osteo Bi-Flex
visit WWW.OSTEOBIFLEX.COMor call us toll free at
1-888-VITAHELP (848-2435).
KEEP OUT OF REACH OF CHILDREN. STORE
AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT.
TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP
IS BROKEN OR MISSING.
CAUTION: If you are pregnant, nursing, taking any medicationsor have any medical condition, consult your doctor before use.Discontinue use and consult your doctor if any adverse reactionsoccur. Not intended for use by persons under the age of 18.
MANUFACTURED BY: REXALL SUNDOWN, INC., BOCA RATON, FL 33487 USA
Proud sponsor of the
Like calcium supplements can helpyour bones, Osteo Bi-Flexcan helpyour joints.*
The natural aging process can addexcessive stress on your joints. Annoyingflare-ups can strike at any time. Add OsteoBi-Flex MSM Formula to your joint careregimen. It contains 1,500 mg ofGlucosamine, a key building block ofcartilage.* With the addition of our Joint
Shield Proprieta ry Ble nd w hich containsChondroitin, MSM and 5-LOXINAdvanced,this revolutionary formula helps revitalize
your joints to keep them jump in.*
5-LOXIN Advanced contains highconcentrations of AKBA, which is importantfor helping with joint flare-ups.*
ADVANCED isa registeredtrademarkofP.L. Thomas-Laila NutraLLCand isused underlicense.InternationalPatentsPending.-
DIRECTIONS FOR ADULT USE: TAKE FOUR (4)CAPLETS PER DAY PREFERABLY WITH FOOD.As a reminder, discuss the supplements andmedications you take with your health care
providers.Note: You have the option of taking fourcaplets together or spread throughout the day.
Other Ingredients: Cellulose (Plant Origin),Crospovidone. Contains
-
8/13/2019 Petito et. al. v. Rexall Sundown
13/18
EXHIBIT C
Case 1:13-cv-08074-PKC Document 1 Filed 11/13/13 Page 13 of 18
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8/13/2019 Petito et. al. v. Rexall Sundown
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Part No. 22-52272
52272 00B B52202 AAC
2012
40POINTS
40POINTS
For more information visitwww.osteobiflex.com
0
330768 03121
Osteo Bi-FlexTriple Strength caplets are apotent combination of highly effectiveingredients in Joint Care Science and is theonly leading brand containing Joint Shieldwith 5-LOXINAdvanced.
See Bottom of Package for our
Ambassadors Clubreward points program.
*These statements have not been evaluated by the Food and DrugAdministration. This product is not intended to diagnose, treat, cure orprevent any disease.
Osteo Bi-Flexis manufactured underthe highest standards for product
quality, purity and potency.
To learn more about Osteo Bi-Flex
visit WWW.OSTEOBIFLEX.COMor call us toll free
1-888-VITAHELP (848-2435)
KEEP OUT OF REACH OF CHILDREN. STORE
AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT.
TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP
IS BROKEN OR MISSING.
CAUTION: If you are pregnant, nursing, taking any medicationsor have any medical condition, consult your doctor before use.Discontinue use and consult your doctor if any adverse reactionsoccur. Not intended for use by persons under the age of 18.
MANUFACTURED BY: REXALL SUNDOWN, INC., BOCA RATON, FL 33487 USA
Proud sponsor of the
Like calcium supplements can helpyour bones, Osteo Bi-Flexcan helpyour joints.*
The natural aging process can add excessive
stress on your joints. Annoying flare-ups can
strike at any time. Add Osteo Bi-Flex Triple
Strength to your joint care regimen. It
contains 1,500 mg of Glucosamine, a key
building block of cartilage.* With the addition
of our Joint Shield Proprietary Blend which
contains Chondroitin, MSM and our 5-LOXIN
Advanced, this revolutionar y formula helps
revitalize your joints to keep them jumpin.*
5-LOXIN Advanced contains high
concentrations of AKBA, which is important
for helping with joint flare-ups.*
ADVANCED isa registeredtrademarkofP.L. Thomas-Laila NutraLLCand isused underlicense.InternationalPatentsPending.
-
DIRECTIONS FOR ADULT USE: TAKE TWO (2)CAPLETS PER DAY WITH FOOD.As a reminder,discuss the supplements and medications you
take with your health care providers.Note: You have the option of taking two capletstogether or spread throughout the day.
Other Ingredients: Crospovidone. Contains
-
8/13/2019 Petito et. al. v. Rexall Sundown
15/18
EXHIBIT D
Case 1:13-cv-08074-PKC Document 1 Filed 11/13/13 Page 15 of 18
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8/13/2019 Petito et. al. v. Rexall Sundown
16/18
Part No. 22-52399
52399 00A B52399 MAB
2012
40POINTS
40POINTS
FnL1010020
01BE5CVFkETkJUWQBIxP1D
30768 188700 2
For more information visitwww.osteobiflex.com
THE
Like calcium supplements can helpyour bones, Osteo Bi-Flexcan helpyour joints.*
The natural aging process can addexcessive stress on your joints. Annoying
flare-ups can strike at any time. Add Osteo
Bi-Flex Joint & Energy to your joint care
regimen. It contains 1,500 mg of
Glucosamine, a key building block of
cartilage.* With the addition of our Joint
Shield Proprietary Blend, which contains
Chondroitin, MSM and 5-LOXINAdvanced,
this revolutionary Energy Formula helps
support energy metabolism and revitalize
your joints to keep them jumpin.*
The only leading brand with 5-LOXIN
Advanced. Starts working to improvejoint comfort within 7 days.*
Based on the results of a GfK Healthcare 2011 survey among physicians who recommend abrand of Glucosamine and Chondroitin or Glucosamine supplements; and the result of aPharmacy Times Survey among pharmacists who recommend a bone/joint strengthenerdietary supplement, 2006-2012.1Basedontwo humanstudieswith5-LOXIN Advancedwheresubjectsrated theirjointhealthovertime,subjectsjointhealthimproved within 7 days, andcontinued to improvethroughoutthe durationof thestudies.**52week NielsenScanTrackdata ending8/25/12.
Osteo Bi-Flex
Joint &Energy helps to:Osteo Bi-Flex
Joint &Energy helps to:
Revitalize Joints*
Promote Mobility*
Support Energy
Metabolism*
Revitalize Joints*
Promote Mobility*
Support Energy
Metabolism*
DOCTOR & PHARMACISTRECOMMENDED BRAND
#
1
Osteo Bi-FlexJoint & Energy caplets are apotent combination of highly effectiveingredients in Joint Care Science and is theonly leading brand containing Joint Shieldwith 5-LOXINAdvanced.
See Bottom of Package for our
Ambassadors Clubreward points program.
*These statements have not been evaluated by the Food and DrugAdministration. This product is not intended to diagnose, treat, cure orprevent any disease.
Osteo Bi-Flexis manufactured underthe highest standards for product
quality, purity and potency.
To learn more about Osteo Bi-Flex
visit WWW.OSTEOBIFLEX.COMor call us toll free
1-888-VITAHELP (848-2435).
KEEP OUT OF REACH OF CHILDREN. STORE
AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT.
TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP
IS BROKEN OR MISSING.
CAUTION:Not intended for use by pregnant or nursing women.If you are taking any medications or have any medical condition,consult your doctor before use. Discontinue use and consultyour doctor if any adverse reactions occur. Not intended for useby persons under the age of 18.
MANUFACTURED BY: REXALL SUNDOWN, INC., BOCA RATON, FL 33487 USA
Proud sponsor of the
Join the millions of people who chooseOsteo Bi-Flexfor their joints everyday, and have made it the #1 brand.**
DOCTOR & PHARMACISTRECOMMENDED BRAND
#
1
ADVANCED isa registeredtrademarkofP.L. Thomas-Laila NutraLLCand isused underlicense.InternationalPatentsPending.
-
DIRECTIONS FOR ADULT USE: TAKE TWO (2) CAPLETSPER DAY PREFERABLY WITH FOOD. As a reminder,discuss the supplements and medications you takewith your health care providers.
Other Ingredients:Cellulose (Plant Origin), Crospovidone.Contains
-
8/13/2019 Petito et. al. v. Rexall Sundown
17/18
EXHIBIT E
Case 1:13 cv 08074 PKC Document 1 Filed 11/13/13 Page 17 of 18
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8/13/2019 Petito et. al. v. Rexall Sundown
18/18
Part No. 22-52526
52526 00A B52514 LAB
2012
40POINTS
40POINTS
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DIRECTIONS FOR ADULT USE: TAKE THREE (3)CAPLETS PER DAY PREFERABLY WITH FOOD.As a reminder, discuss the supplements andmedications you take with your health careproviders.
Note: You have the option of taking threecaplets together or spread throughout the day.
Other Ingredients: Crospovidone.Contains
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