Free Declaration - District Court of Delaware - Delaware

Case 1:04-cv—00884-SLR Document 71-21 Filed 07/17/2006 Page 1 014
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I , 1. é Claims _________,__________, an panting in me appllcallun.
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Case 1:04-cv—00884-SLR D .
ocument 71-21 Fngd 07/1
7/2006 Page 3 of 4
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Serial No. 613779 \
Arr Unit 123 2
The specification ls objected to under 35 U.S-C.
H2, first paragraph, as Iaillng to provide an ennbltng .
disclosure. This paragraph of the statute requires that
the npecification shall contain a written description
of the invention ·and of the nanoer and process of
making and using it, in such full, clear. concise and
exact terms as to enable any person skilled in the art I
to which it pertains, or with which it is most nearly
connected. to make and use the some, and shall set '
Earth the beat node contenplated hy the inventor of V
carrying out his invention. The terminology "in oral L
~ dosage {arm" urd•‘"in the Earn of a tablet" and ”i,n the
form of a capsule" is considered beyond the scope of
enabienent as Applicant indicates that subllngual ‘
tablet; are unsatisfactory. ·
Claims 1-10 are rejected under 35 1.\.S.C'. Hz,
' first paragraph. for the reasons set (orth in the
objection to the specification. The ternlnulogy
criticized supra and the term "suhztantiatly dissolved
and absorbed in the gastrointestinal tract of said
I human" is also considered vague and indefinite as to
exactly what is intended and the netes and bounds
` thereof. The functional language "said composition
being capable of kliszolving and being absorbed in the
gastrointestinal tract of said honour" is further seen
I as inproper. .


Case 1 .04-cv—00884-SLR Document 71 -21 Filed 07/17/2006 Page 4 of 4 »e
l Serial No. GU779 —
. Art Unit 123 , 3
The following is a quotation of the appropriate
paragraphs of 35 U.S.C. I0? that form the basis for the r
_ rejections under this section nude in this 0EEice
- action:
A person shell be entitled to a patent unless:
_ . (b) the invention was patented or _ 3
described in a printed puhltcation " 1
in this nt 2 foreign countrj or iu A V,
public use or on sale in this
country. more than one year print tn
the date of application for patent A
in the United s¤:aces._ l
· Claims 1-X0 are rejected under 35 \1.$.C. 102 b as
anticipated by or. in che al.tcz¤¤t1ve, under 35 u.s.c. 7
‘ 103 as obvious over Zaoral et al. or the Chem. Abstr-
acts citation of Iiinter ec al. Each reference teaches
the oral administration of l—deamtn¤—8—D-arginine Y
vasopressin ns claimed by applicant. The choice of “·
tablet, capsule or liquid form is deemed Lo be within
the skill of the artisan. ` A
· No claims are allowed. Y
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