IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`077350.0355
`
`In re Patent Application of:
`Roychowdhury et al.
`
`Application No.:
`
`To Be Assigned
`
`Filed:
`
`Concurrently Herewith
`
`Examiner
`
`)
`)
`)
`) Group Art Unit
`)
`)
`)
`
`Confirmation No.
`
`To Be Assigned
`
`To Be Assigned
`
`To Be Assigned
`
`For:
`
`DEXMEDETOMIDINE PREMIX FORMULATION
`
`ACCELERATED EXAMINATION SUPPORT DOCUMENT
`
`Filed Electronically VIA EFS
`Mail Stop Petitions
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`This Accelerated Examination Support Document is provided in support of the Petition
`
`for Accelerated Examination and application filed herewith under 35 U.S.C. § 11 l(a).
`
`Identification of the Limitations of the Claims Disclosed by the Cited References
`
`begins on page 2 of this paper.
`
`Detailed Explanation of Patentability begins on Page 36 of this paper.
`
`Statement of Disqualification of Prior Art begins on page 56 of this paper.
`
`Statement of Utility begins on Page 57 of this paper.
`
`Showing of Support of Each Claim Limitation and Statement Regarding Means
`
`Plus Function begins on page 58 of this paper.
`
`Conclusion begins on page 61 of this paper.
`
`NY02:747828.1
`
`1
`
`Hospira, Exh. 2007, p. 1
`
`

`
`PATENT
`077350.0355
`
`Identification of the Limitations of the Claims Disclosed by the Cited References
`
`1.
`
`"Dexmedetomidine HCL Draft Labeling: Precedex™ Dexmedetomidine
`
`Hydrochloride Injection," FDA approved label, dated December 17, 1999, and available
`
`online July 26, 2001, pages 1-13. ("the Precedex™ label").
`
`a.
`
`Independent Claim 1
`
`A ready to use liquid pharmaceutical composition
`
`The Precedex™ label discloses a liquid pharmaceutical composition (p. 1, ifl-if2; p. 6, if4;
`
`p. 12, if2-if3).
`
`Independent claim 1 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest a ready to use liquid pharmaceutical composition. The
`
`Precedex™ label discloses dexmedetomidine hydrochloride at a concentration of 100 µg/mL
`
`disposed within 2 mL clear glass vials and 2 mL ampoules. In contrast to claim 1, which is
`
`directed to a 0.005 to about 50 µg/mL dexmedetomidine composition disposed within a sealed
`
`glass container that is formulated as a ready to use liquid pharmaceutical composition for
`
`administration to a subject upon removal from the sealed glass container, the dexmedetomidine
`
`composition of the Precedex™ label must be removed from the 2 mL vial or ampoule and
`
`diluted to a concentration of 4 µg/mL prior to administration to a subject (p. 12, if6-if8; p. 13, if5-
`
`if6).
`
`for parenteral administration to a subject, comprising
`
`The Precedex™ label discloses a pharmaceutical composition wherein the composition is
`
`formulated as a liquid for parenteral administration to a subject (p. 1, ifl-if2; p. 6, if4; p. 12, if2-
`
`i13).
`
`Independent claim 1 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest a ready to use liquid pharmaceutical composition for parenteral
`
`administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt
`
`thereof at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container. The Precedex™ label discloses dexmedetomidine hydrochloride at a concentration of
`
`100 µg/mL disposed within 2 mL clear glass vials and 2 mL ampoules. In contrast to claim 1,
`
`which is directed to a 0.005 to about 50 µg/mL dexmedetomidine composition disposed within a
`
`sealed glass container that is formulated as a ready to use liquid pharmaceutical composition for
`
`administration to a subject upon removal from the sealed glass container, the dexmedetomidine
`
`NY02:747828. I
`
`2
`
`Hospira, Exh. 2007, p. 2
`
`

`
`PATENT
`077350.0355
`
`composition of the Precedex™ label must be removed from the 2 mL vial or ampoule and
`
`diluted to a concentration of 4 µg/mL prior to administration to a subject (p. 12, if6-if8; p. 13, if5-
`
`if6).
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof
`
`The Precedex™
`
`label discloses
`
`a pharmaceutical
`
`composition
`
`comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof (p. 1, ifl-if2; p. 13, if5).
`
`Independent claim 1 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest a ready to use liquid pharmaceutical composition for parenteral
`
`administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt
`
`thereof at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container. The Precedex™ label discloses dexmedetomidine hydrochloride at a concentration of
`
`100 µg/mL disposed within 2 mL clear glass vials and 2 mL ampoules. In contrast to claim 1,
`
`which is directed to a 0.005 to about 50 µg/mL dexmedetomidine composition disposed within a
`
`sealed glass container that is formulated as a ready to use liquid pharmaceutical composition for
`
`administration to a subject upon removal from the sealed glass container, the dexmedetomidine
`
`composition of the Precedex™ label must be removed from the 2 mL vial or ampoule and
`
`diluted to a concentration of 4 µg/mL prior to administration to a subject (p. 12, if6-if8; p. 13, if5-
`
`if6).
`
`at a concentration of about 0.005 to about 50 µg/mL
`
`The Precedex™
`
`label
`
`discloses
`
`a pharmaceutical
`
`composition
`
`comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the dexmedetomidine is
`
`present at a concentration of about 4 µg/mL (p. 12, if6-if8; p. 13, if5-if6).
`
`Independent claim 1 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest a ready to use liquid pharmaceutical composition for parenteral
`
`administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt
`
`thereof at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container. The Precedex™ label discloses dexmedetomidine hydrochloride at a concentration of
`
`100 µg/mL disposed within 2 mL clear glass vials and 2 mL ampoules. In contrast to claim 1,
`
`which is directed to a 0.005 to about 50 µg/mL dexmedetomidine composition disposed within a
`
`sealed glass container that is formulated as a ready to use liquid pharmaceutical composition for
`
`administration to a subject upon removal from the sealed glass container, the dexmedetomidine
`
`NY02:747828.1
`
`3
`
`Hospira, Exh. 2007, p. 3
`
`

`
`PATENT
`077350.0355
`
`composition of the Precedex™ label must be removed from the 2 mL vial or ampoule and
`
`diluted to a concentration of 4 µg/mL prior to administration to a subject (p. 12, ~6-iJ8; p. 13, ~5-
`
`iJ6).
`
`disposed within a sealed glass container.
`
`The Precedex™ label discloses a pharmaceutical composition wherein the composition is
`
`disposed within a sealed glass container (p. 13, iJ5-iJ6).
`
`Independent claim 1 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest a ready to use liquid pharmaceutical composition for parenteral
`
`administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt
`
`thereof at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container. The Precedex™ label discloses dexmedetomidine hydrochloride at a concentration of
`
`100 µg/mL disposed within 2 mL clear glass vials and 2 mL ampoules. In contrast to claim 1,
`
`which is directed to a 0.005 to about 50 µg/mL dexmedetomidine composition disposed within a
`
`sealed glass container that is formulated as a ready to use liquid pharmaceutical composition for
`
`administration to a subject upon removal from the sealed glass container, the dexmedetomidine
`
`composition of the Precedex™ label must be removed from the 2 mL vial or ampoule and
`
`diluted to a concentration of 4 µg/mL prior to administration to a subject (p. 12, iJ6-iJ8; p. 13, iJ5-
`
`iJ6).
`
`b.
`
`Dependent Claim 2
`
`The ready to use
`
`liquid pharmaceutical composition of claim 1, wherein the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0. 05
`
`to about 15 ug/mL.
`
`The Precedex™
`
`label
`
`discloses
`
`a
`
`pharmaceutical
`
`composition
`
`comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the dexmedetomidine is
`
`present at a concentration ofabout 4 µg/mL (p. 12, if6-iJ8; p. 13, iJ5-iJ6).
`
`Claim 2 is not anticipated by the Precedex™ label for at least the reason discussed with
`
`respect to claim 1. For example, the Precedex™ label fails to disclose or suggest a ready to use
`
`liquid pharmaceutical composition for parenteral administration to a subject, comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.05
`
`to about 15 µg/mL disposed within a sealed glass container. The Precedex™ label discloses
`
`dexmedetomidine hydrochloride at a concentration of 100 µg/mL disposed within 2 mL clear
`
`NY02:747828. l
`
`4
`
`Hospira, Exh. 2007, p. 4
`
`

`
`PATENT
`077350.0355
`
`glass vials and 2 mL ampoules. In contrast to claim 2, which is directed to a 0.05 to about 15
`
`µg/mL dexmedetomidine composition disposed within a sealed glass container that is formulated
`
`as a ready to use liquid pharmaceutical composition for administration to a subject upon removal
`
`from the sealed glass container, the dexmedetomidine composition of the Precedex™ label must
`
`be removed from the 2 mL vial or ampoule and diluted to a concentration of 4 µg/mL prior to
`
`administration to a subject (p. 12, ~6-iJ8; p. 13, iJ5-iJ6).
`
`c.
`
`Dependent Claim 3
`
`The ready
`
`to use
`
`liquid pharmaceutical composition of claim 1, wherein
`
`the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0. 5
`
`to about 10 ug/mL.
`
`The Precedex™
`
`label
`
`discloses
`
`a pharmaceutical
`
`composition
`
`comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the dexmedetomidine is
`
`present at a concentration of about 4 µg/mL (p. 12, ~6-iJ8; p. 13, ~5-~6).
`
`Claim 3 is not anticipated by the Precedex™ label for at least the reason discussed with
`
`respect to claim 1. For example, the Precedex™ label fails to disclose or suggest a ready to use
`
`liquid pharmaceutical composition for parenteral administration to a subject, comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.5 to
`
`about 10 µg/mL disposed within a sealed glass container. The Precedex™ label discloses
`
`dexmedetomidine hydrochloride at a concentration of 100 µg/mL disposed within 2 mL clear
`
`glass vials and 2 mL ampoules. In contrast to claim 3, which is directed to a 0.5 to about 10
`
`µg/mL dexmedetomidine composition disposed within a sealed glass container that is formulated
`
`as a ready to use liquid pharmaceutical composition for administration to a subject upon removal
`
`from the sealed glass container, the dexmedetomidine composition of the Precedex™ label must
`
`be removed from the 2 mL vial or ampoule and diluted to a concentration of 4 µg/mL prior to
`
`administration to a subject (p. 12, ~6-iJ8; p. 13, ~5-~6).
`
`d.
`
`Dependent Claim 4
`
`The ready
`
`to use
`
`liquid pharmaceutical composition of claim 1, wherein the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 1 to
`
`about 7 ug/mL.
`
`The Precedex™
`
`label discloses
`
`a pharmaceutical
`
`composition
`
`comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the dexmedetomidine is
`
`NY02:747828. l
`
`5
`
`Hospira, Exh. 2007, p. 5
`
`

`
`PATENT
`077350.0355
`
`present at a concentration of about 4 µg/mL (p. 12, ~6-~8; p. 13, ~5-~6).
`
`Claim 4 is not anticipated by the Precedex™ label for at least the reason discussed with
`
`respect to claim I. For example, the Precedex™ label fails to disclose or suggest a ready to use
`
`liquid pharmaceutical composition for parenteral administration to a subject, comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 to
`
`about 7 µg/mL disposed within a sealed glass container. The Precedex™ label discloses
`
`dexmedetomidine hydrochloride at a concentration of 100 µg/mL disposed within 2 mL clear
`
`glass vials and 2 mL ampoules. In contrast to claim 4, which is directed to an about 1 to about 7
`
`µg/mL dexmedetomidine composition disposed within a sealed glass container that is formulated
`
`as a ready to use liquid pharmaceutical composition for administration to a subject upon removal
`
`from the sealed glass container, the dexmedetomidine composition of the Precedex™ label must
`
`be removed from the 2 mL vial or ampoule and diluted to a concentration of 4 µg/mL prior to
`
`administration to a subject (p. 12, ~6-~8; p. 13, ~5-~6).
`
`e.
`
`Dependent Claim 5
`
`The ready to use liquid pharmaceutical composition of claim 1, further comprising
`
`sodium chloride at a concentration of between about 0. OJ and about 2. 0 weight percent.
`
`The Precedex™ label discloses a pharmaceutical composition comprising sodium
`
`chloride at a concentration of between about 0.01 and about 2.0 weight percent (p. 1, ~2; p. 12,
`
`~6-~8).
`
`Claim 5 is not anticipated by the Precedex™ label for at least the reason discussed with
`
`respect to claim 1. For example, the Precedex™ label fails to disclose or suggest a ready to use
`
`liquid pharmaceutical composition for parenteral administration to a subject, comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005
`
`to about 50 µg/mL disposed within a sealed glass container. The Precedex™ label discloses
`
`dexmedetomidine hydrochloride at a concentration of 100 µg/mL disposed within 2 mL clear
`
`glass vials and 2 mL ampoules. In contrast to claim 5, which is directed to a 0.005 to about 50
`
`µg/mL dexmedetomidine composition disposed within a sealed glass container that is formulated
`
`as a ready to use liquid pharmaceutical composition for administration to a subject upon removal
`
`from the sealed glass container, the dexmedetomidine composition of the Precedex™ label must
`
`be removed from the 2 mL vial or ampoule and diluted to a concentration of 4 µg/mL prior to
`
`administration to a subject (p. 12, ~6-~8; p. 13, ~5-~6).
`
`NY02:747828.1
`
`6
`
`Hospira, Exh. 2007, p. 6
`
`

`
`PATENT
`077350.0355
`
`f.
`
`Dependent Claim 6
`
`The ready to use liquid pharmaceutical composition of claim 5, wherein the sodium
`
`chloride is present at a concentration of about 0. 9 weight percent.
`
`The Precedex™ label discloses a pharmaceutical composition comprising sodium
`
`chloride, wherein the sodium chloride is present at a concentration of about 0.9 weight percent
`
`(p. 1, i!2; p. 12, i!6-i!8).
`
`Claim 6 is not anticipated by the Precedex™ label for at least the reason discussed with
`
`respect to claim 1. For example, the Precedex™ label fails to disclose or suggest a ready to use
`
`liquid pharmaceutical composition for parenteral administration to a subject, comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005
`
`to about 50 µg/mL disposed within a sealed glass container. The Precedex™ label discloses
`
`dexmedetomidine hydrochloride at a concentration of 100 µg/mL disposed within 2 mL clear
`
`glass vials and 2 mL ampoules. In contrast to claim 6, which is directed to a 0.005 to about 50
`
`µg/mL dexmedetomidine composition disposed within a sealed glass container that is formulated
`
`as a ready to use liquid pharmaceutical composition for administration to a subject upon removal
`
`from the sealed glass container, the dexmedetomidine composition of the Precedex™ label must
`
`be removed from the 2 mL vial or ampoule and diluted to a concentration of 4 µg/mL prior to
`
`administration to a subject (p. 12, i!6-i!8; p. 13, if5-if6).
`
`g.
`
`Dependent Claim 7
`
`The ready to use liquid pharmaceutical composition of claim 1, wherein the composition
`
`is formulated as a total volume selected from the group consisting of 20 ml, 50 ml and 100 mL.
`
`The Precedex™
`
`label
`
`discloses
`
`a pharmaceutical
`
`composition
`
`comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of 100 µg/mL
`
`that is disposed within 2 mL glass vials or 2 mL glass ampoules (p. 13, if5-i!6).
`
`Claim 7 is not anticipated by the Precedex™ label because the Precedex™ label fails to
`
`suggest or describe a
`
`ready
`
`to use
`
`liquid pharmaceutical composition comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005
`
`to about 50 µg/mL formulated as a total volume selected from the group consisting of 20 mL, 50
`
`mL and 100 mL.
`
`Additionally, claim 7 is not anticipated by the Precedex™ label for at least the reason
`
`discussed with respect to claim 1. For example, the Precedex™ label fails to disclose or suggest
`
`NY02:747828.1
`
`7
`
`Hospira, Exh. 2007, p. 7
`
`

`
`PATENT
`077350.0355
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject,
`
`comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of
`
`about 0.005 to about 50 µg/mL disposed within a sealed glass container. The Precedex™ label
`
`discloses dexmedetomidine hydrochloride at a concentration of 100 µg/mL disposed within 2
`
`ml clear glass vials and 2 ml ampoules. In contrast to claim 7, which is directed to a 0.005 to
`
`about 50 µg/mL dexmedetomidine composition disposed within a sealed glass container that is
`
`formulated as a ready to use liquid pharmaceutical composition for administration to a subject
`
`upon removal from the sealed glass container, the dexmedetomidine composition of the
`
`Precedex™ label must be removed from the 2 mL vial or ampoule and diluted to a concentration
`
`of 4 µg/mL prior to administration to a subject (p. 12, if6-if8; p. 13, if5-if6).
`
`2.
`
`U.S. Publication No. 20100197694, published August 5, 2010 to Horn 1 ("Horn 1").
`
`a.
`
`Independent Claim 1
`
`A ready to use liquid pharmaceutical composition
`
`Horn 1 discloses a liquid pharmaceutical composition (p. 5, i!87-i!90).
`
`Independent claim 1 is not anticipated by Horn 1 because Horn 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`for parenteral administration to a subject, comprising
`
`Horn 1 discloses a pharmaceutical composition wherein the composition is formulated
`
`for parenteral administration to a subject (p. 5, if88-if90).
`
`Independent claim 1 is not anticipated by Horn 1 because Hom 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof
`
`Horn 1 discloses a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof (p. 1, if8-ifl l; p. 2, ~17; p. 2, ~33; p. 5, i!87-i!88).
`
`NY02:747828. l
`
`8
`
`Hospira, Exh. 2007, p. 8
`
`

`
`PATENT
`077350.0355
`
`Independent claim 1 is not anticipated by Hom I because Horn 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`at a concentration of about 0.005 to about 50 µg/mL,
`
`Horn 1 discloses a composition comprising dexmedetomidine at a concentration of from
`
`about 0.0001 % to about 0.05% (i.e., from about 1 µg/mL to about 50 µg/mL); from about
`
`0.001 % to about 0.05% (i.e., from about 10 µg/mL to about 500 µg/mL); from about 0.01 % to
`
`about 0.025% (i.e., from about I 00 µg/mL to about 250 µg/mL); and from about 0.01 % to about
`
`0.02% (i.e., from about 100 µg/mL to about 200 µg/mL) weight by volume of the composition.
`
`(p. 1, ~8-~11; p. 2, ~17; p. 2, ~33; p. 5, ~87-~88).
`
`Independent claim 1 is not anticipated by Horn 1 because Hom 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`disposed within a sealed glass container.
`
`Independent claim 1 is not anticipated by Horn 1 because Horn 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is disposed
`
`within a sealed glass container.
`
`Additionally, independent claim 1 is not anticipated by Horn 1 because Horn 1 fails to
`
`disclose or suggest a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that
`
`is formulated as a ready to use liquid pharmaceutical composition for parenteral administration
`
`to a subject and that is disposed within a sealed glass container.
`
`b.
`
`Dependent Claim 2
`
`The ready
`
`to use
`
`liquid pharmaceutical composition of claim 1, wherein
`
`the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0. 05
`
`to about 15 ug/mL.
`
`NY02:747828.1
`
`9
`
`Hospira, Exh. 2007, p. 9
`
`

`
`PATENT
`077350.0355
`
`Hom 1 discloses a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof at a concentration of from about 0.0001 % to about
`
`0.05% (i.e., from about 1 µg/mL to about 50 µg/mL); from about 0.001 % to about 0.05% (i.e.,
`
`from about 10 µg/mL to about 500 µg/mL); from about 0.01% to about 0.025% (i.e., from about
`
`100 µg/mL to about 250 µg/mL); and from about 0.01% to about 0.02% (i.e., from about 100
`
`µg/mL to about 200 µg/mL) weight by volume of the composition (p. 1, ~8-~11; p. 2, ~17; p. 2,
`
`~33; p. 5, ~87-~88).
`
`Dependent claim 2 is not anticipated by Hom 1 because Horn 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.05 to about 15 µg/mL that is formulated as a
`
`ready to use liquid pharmaceutical composition for parenteral administration to a subject and that
`
`is disposed within a sealed glass container.
`
`c.
`
`Dependent Claim 3
`
`The ready to use
`
`liquid pharmaceutical composition of claim 1, wherein
`
`the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0. 5
`
`to about 10 uglmL.
`
`Hom 1 discloses a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof at a concentration of from about 0.0001 % to about
`
`0.05% (i.e., from about 1 µg/mL to about 50 µg/mL ); from about 0.001 % to about 0.05% (i.e.,
`
`from about 10 µg/mL to about 500 µg/mL); from about 0.01 % to about 0.025% (i.e., from about
`
`100 µg/mL to about 250 µg/mL); and from about 0.01% to about 0.02% (i.e., from about 100
`
`µg/mL to about 200 µg/mL) weight by volume of the composition (p. 1, ~8-~11; p. 2, ~17; p. 2,
`
`i!33; p. 5, i!87-i!88).
`
`Dependent claim 3 is not anticipated by Horn 1 because Horn 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.5 to about 10 µg/mL that is formulated as a
`
`ready to use liquid pharmaceutical composition for parenteral administration to a subject and that
`
`is disposed within a sealed glass container.
`
`d.
`
`Dependent Claim 4
`
`The ready
`
`to use
`
`liquid pharmaceutical composition of claim 1, wherein
`
`the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 1 to
`
`NY02:74782Kl
`
`10
`
`Hospira, Exh. 2007, p. 10
`
`

`
`PATENT
`077350.0355
`
`about 7 ug/mL.
`
`Horn 1 discloses a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof at a concentration of from about 0.0001 % to about
`
`0.05% (i.e., from about 1 µg/mL to about 50 µg/mL); from about 0.001 % to about 0.05% (i.e.,
`
`from about 10 µg/mL to about 500 µg/rnL); from about 0.01 % to about 0.025% (i.e., from about
`
`100 µg/mL to about 250 µg/mL); and from about 0.01 % to about 0.02% (i.e., from about 100
`
`µg/mL to about 200 µg/mL) weight by volume of the composition (p. 1, i18-i111; p. 2, ~17; p. 2,
`
`i133; p. 5, i187-i188).
`
`Dependent claim 4 is not anticipated by Hom 1 because Hom 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 1 to about 7 µg/mL that is formulated as a
`
`ready to use liquid pharmaceutical composition for parenteral administration to a subject and that
`
`is disposed within a sealed glass container.
`
`e.
`
`Dependent Claim 5
`
`The ready to use liquid pharmaceutical composition of claim 1, further comprising
`
`sodium chloride at a concentration of between about 0. OJ and about 2. 0 weight percent.
`
`Horn 1 discloses a pharmaceutical composition comprising sodium chloride at a
`
`concentration of between about 0.01 and about 2.0 weight percent (p. 5, i176).
`
`Claim 5 is not anticipated by Horn 1 for at least the reason discussed with respect to
`
`claim 1. For example, Horn 1 fails to disclose or suggest a pharmaceutical composition
`
`comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of
`
`about 0.005 to about 50 µg/rnL that is formulated as a ready to use liquid pharmaceutical
`
`composition for parenteral administration to a subject and that is disposed within a sealed glass
`
`container.
`
`f.
`
`Dependent Claim 6
`
`The ready to use liquid pharmaceutical composition of claim 5, wherein the sodium
`
`chloride is present at a concentration of about 0.9 weight percent.
`
`Horn 1 discloses a pharmaceutical composition comprising sodium chloride at a
`
`concentration of between about 0.01 and about 2.0 weight percent (p. 5, i176).
`
`Dependent claim 6 is not anticipated by Horn 1 because Hom 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising sodium chloride at a concentration of about
`
`NY02:747828.l
`
`11
`
`Hospira, Exh. 2007, p. 11
`
`

`
`PATENT
`077350.0355
`
`0.9 weight percent. Additionally, claim 6 is not anticipated by Hom 1 for at least the reason
`
`discussed with respect to claim 1. For example, Hom 1 fails to disclose or suggest a
`
`pharmaceutical composition comprising dexmedetomidine or a pharmaceutically acceptable salt
`
`thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as a ready to use
`
`liquid pharmaceutical composition for parenteral administration to a subject and that is disposed
`
`within a sealed glass container.
`
`g.
`
`Dependent Claim 7
`
`The ready to use liquid pharmaceutical composition of claim I, wherein the composition
`
`is formulated as a total volume selected from the group consisting of 20 mL, 5 0 ml and I 00 ml.
`
`Dependent claim 7 is not anticipated by Hom I because Hom 1 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL wherein the
`
`composition is formulated as a total volume selected from the group consisting of 20 mL, 50 mL
`
`and 100 mL.
`
`Additionally claim 7 is not anticipated by Horn 1 for at least the reason discussed with
`
`respect to claim 1. For example, Horn 1 fails to disclose or suggest a pharmaceutical
`
`composition comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a
`
`concentration of about 0.005 to about 50 µg/mL that is formulated as a ready to use liquid
`
`pharmaceutical composition for parenteral administration to a subject and that is disposed within
`
`a sealed glass container.
`
`3.
`
`U.S. Publication No. 20110152271, published June 23, 2011 to Horn ("Horn 2").
`
`a.
`
`Independent Claim 1
`
`A ready to use liquid pharmaceutical composition
`
`Horn 2 discloses a liquid pharmaceutical composition (p. 2, ~20; p. 2, ~31; p. 3, ~36-~37).
`
`Independent claim 1 is not anticipated by Horn 2 because Horn 2 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`for parenteral administration to a subject, comprising
`
`NY02:747828. l
`
`12
`
`Hospira, Exh. 2007, p. 12
`
`

`
`PATENT
`077350.0355
`
`Horn 2 discloses a pharmaceutical composition for parenteral administration to a subject
`
`(p. 2, i120; p. 2, i131; p. 3' i136-i13 7).
`
`Independent claim 1 is not anticipated by Horn 2 because Horn 2 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof
`
`Horn 2 discloses a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof (p. 1, i!7; p. 1, i!9; p. 1, iil 4; p. 2, i!29; p. 2, i!33).
`
`Independent claim 1 is not anticipated by Horn 2 because Horn 2 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`at a concentration of about 0. 005 to about 50 µglmL
`
`Horn 2 discloses a composition comprising dexmedetomidine at a concentration of from
`
`between about 0.0001 % to about 0.05% (i.e., from between about l µg/mL to about 500 µg/mL);
`
`from about 0.001 % to about 0.025% (i.e., from about 10 µg/mL to about 250 µg/mL); from
`
`about 0.01% to about 0.025% (i.e., from about 100 µg/mL to about 250 µg/mL); and from about
`
`0.01 % to about 0.02% (i.e., from about 100 µg/mL to about 200 µg/mL) weight by volume of the
`
`composition (p. 1, i!7; p. 1, i!9; p. 1, i!14; p. 2, i129; p. 2, i133).
`
`Independent claim 1 is not anticipated by Horn 2 because Horn 2 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is formulated as
`
`a ready to use liquid pharmaceutical composition for parenteral administration to a subject and
`
`that is disposed within a sealed glass container.
`
`disposed within a sealed glass container.
`
`Independent claim 1 is not anticipated by Horn 2 because Horn 2 fails to disclose or
`
`suggest a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that is disposed
`
`NY02:747828. l
`
`13
`
`Hospira, Exh. 2007, p. 13
`
`

`
`PATENT
`077350.0355
`
`within a sealed glass container.
`
`Additionally, independent claim 1 is not anticipated by Hom 2 because Horn 2 fails to
`
`disclose or suggest a pharmaceutical composition comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that
`
`is formulated as a ready to use liquid pharmaceutical composition for parenteral administration
`
`to a subject and that is disposed within a sealed glass container.
`
`b.
`
`Dependent Claim 2
`
`The ready to use
`
`liquid pharmaceutical composition of claim 1, wherein
`
`the
`
`dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0. 05
`
`to about 15 ug/mL.
`