Petito et. al. v. Nature's Bounty

8/14/2019 Petito et. al. v. Nature's Bounty

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Case 1:13-cv-08077-CM Document 1 Filed 11/13/13 Page 1 of 16


















“EXHIBIT A”




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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 .

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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 .

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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 ) .

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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 .

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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

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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




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 ,




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 .




“EXHIBIT B”




/22/13droitin Formula -- 80 Coated Caplets - V…

acost. com/natures-bounty-flex-a-min-triple-strength-glucosamine-chondroitin-formula-80-coated-ca…

Nature's Bounty Flex-a-minSuper Glucosamine 2000 Plus

-- 60 Coated Tablets

20% off Retail pric e: $14.99

Vita cost pr ice: $11.99

Solaray Glucosamine 1500plus Chocolate Smoothie --

12.3 oz

30% off Retail price: $29.19

Vitacost price: $20.29

Osteo BiFlex Glucosamine

Chondroitin MSM w ith 5-LoxinAdvanced™ -- 75 Coated

Caplets



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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!

Looking for a dietary supplement to nourish and cushion your joints?

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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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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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“EXHIBIT C”




Documents

Petito et. al. v. Nature's Bounty