IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`077350.0359
`
`In re Patent Application of:
`Roychowdhury et al.
`
`)
`)
`)
`)
`) Group Art Unit
`)
`)
`)
`For: METHODS OF TREATMENT USING A DEXMEDETOMIDINE PREMIX
`FORMULATION
`
`Application No.:
`
`To Be Assigned
`
`To Be Assigned
`
`Examiner
`
`To Be Assigned
`
`Filed:
`
`Concurrently Herewith
`
`Confirmation No.
`
`To Be Assigned
`
`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 filed herewith and the application filed herewith under 35 U.S.C. §
`
`lll(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 44 of this paper.
`
`Statement of Disqualification of Prior Art begins on page 74 of this paper.
`
`Statement of Utility begins on Page 75 of this paper.
`
`Showing of Support of Each Claim Limitation and Statement Regarding Means
`
`Plus Function begins on page 76 of this paper.
`
`Conclusion begins on page 82 of this paper.
`
`NY02:758299.2
`
`1
`
`Hospira, Exh. 2007, p. 1
`
`

`
`PATENT
`077350.0359
`
`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 method of providing sedation to a patient in need thereof, the method comprising
`
`The Precedex™ label discloses a method of providing sedation to a patient in need
`
`thereof (p. 1, if3; p. 6, i!4).
`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-
`
`i!6).
`
`administering to the patient an effective amount of a composition, wherein the
`
`compostion ccomprises dexmedetomidine or a pharmaceutically acceptable salt thereof
`
`The Precedex™ label discloses administering to a patient an effective amount of a
`
`composition, wherein the compostion comprises dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof (p. 1, ifl-'112; p. 6, if4; p. 12, if2-i!3; p. 13, iJ5).
`
`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
`
`NY02:758299.2
`
`2
`
`Hospira, Exh. 2007, p. 2
`
`

`
`PATENT
`077350.0359
`
`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-
`
`iJ6).
`
`at a concentration of about 0.005 to about 50 µglmL,
`
`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, iJ6-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
`
`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, iJ5-
`
`if6).
`
`wherein the composition is a ready to use liquid pharmaceutical composition for
`
`parenteral administration to the patient
`
`The Precedex™ label discloses a liquid pharmaceutical composition for parenteral
`
`administration to a patient (p. 1, ilHl2; p. 6, iJ4; p. 12, iJ2-iJ3).
`
`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
`
`NY02:758299.2
`
`3
`
`Hospira, Exh. 2007, p. 3
`
`

`
`PATENT
`077350.0359
`
`diluted to a concentration of 4 µg/mL prior to administration to a subject (p. 12, if6-if8; p. 13, if5-
`
`if6).
`
`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, 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
`
`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).
`
`b.
`
`Dependent Claim 2
`
`The method of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable
`
`salt thereof is at a concentration of about 0. 05 to about 15 uglmL.
`
`The Precedex™ label discloses a pharmaceutical composition comprising
`
`dexmedetomidine or a phannaceutically acceptable salt thereof, wherein the dexmedetomidine is
`
`present at a concentration of about 4 µg/mL (p. 12, if6-if8; p. 13, i15-if6).
`
`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, comp1ising
`
`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
`
`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
`
`NY02:758299.2
`
`4
`
`Hospira, Exh. 2007, p. 4
`
`

`
`PATENT
`077350.0359
`
`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, iJ5-iJ6).
`
`c.
`
`Dependent Claim 3
`
`The method 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, iJ6-iJ8; p. 13, iJ5-if6).
`
`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, i-f6-iJ8; p. 13, i-f5-iJ6).
`
`d.
`
`Dependent Claim 4
`
`The method 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
`
`present at a concentration of about 4 µg/mL (p. 12, iJ6-if8; p. 13, iJ5-iJ6).
`
`Claim 4 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
`
`NY02:758299.2
`
`5
`
`Hospira, Exh. 2007, p. 5
`
`

`
`PATENT
`077350.0359
`
`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, if6-if8; p. 13, if 5-if6).
`
`e.
`
`Dependent Claim 5
`
`The method of claim I, wherein the dexmedetomidine or pharmaceutically acceptable
`
`salt thereof is at a concentration of about 4 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, if6-if8; p. 13, if5-if6).
`
`Dependent claim 5 is not anticipated by the Precedex™ label because the
`
`PrecedexTM label fails to disclose or suggest a pharmaceutical composition comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 4
`
`µg/mL that is fommlated as a ready to use liquid for parenteral administration to a subject and
`
`that is 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 4 µg/mL
`
`dexmedetomidine composition disposed within a sealed glass container that is formulated as a
`
`ready to use liquid for parenteral 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).
`
`f.
`
`Dependent Claim 6
`
`The method of claim I, wherein the composition is administered perioperatively
`
`NY02:758299.2
`
`6
`
`Hospira, Exh. 2007, p. 6
`
`

`
`PATENT
`077350.0359
`
`Dependent claim 6 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest administration of a composition comprising dexmedetomidine to
`
`a patient perioperatively.
`
`Additionally, dependent claim 6 is not anticipated by the Precedex™ label because the
`
`Precedex™ label 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 for parenteral administration to a
`
`subject and that is 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 dexmedetomidine
`
`composition at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container that is formulated as a ready to use liquid for parenteral 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).
`
`g.
`
`Dependent Claim 7
`
`The method of claim 6, wherein the composition is administered before or after surgery.
`
`Dependent claim 7 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to suggest or describe administration of a composition comprising dexmedetomidine
`
`to a patient before or after surgery.
`
`Additionally, dependent claim 7 is not anticipated by the Precedex™ label because the
`
`Precedex™ label 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 for parenteral administration to a
`
`subject and that is 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 dexmedetomidine
`
`composition at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container that is formulated as a ready to use liquid for parenteral administration to a subject
`
`upon removal from the sealed glass container, the dexmedetomidine composition of the
`
`NYD2:758299.2
`
`7
`
`Hospira, Exh. 2007, p. 7
`
`

`
`PATENT
`077350.0359
`
`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-i18; p. 13, i15-if6).
`
`h.
`
`Dependent Claim 8
`
`The method of claim 1, wherein the composition is administered to the patient in an
`
`intensive care unit.
`
`The Precedex™ label discloses administering a composition comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof to a patient in an intensive care
`
`unit (p. 4, if4; p. 6, if4).
`
`Dependent claim 8 is not anticipated by the Precedex™ label because the Precedex™
`
`label 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 for parenteral administration to a subject and that is
`
`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 8 which is directed to a dexmedetomidine composition at a
`
`concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass container that is
`
`formulated as a ready to use liquid for parenteral 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).
`
`L
`
`Dependent Claim 9
`
`The method of claim 1, wherein the patient is non-ventilated or intubated.
`
`The Precedex™ label discloses administration of a composition comprising
`
`dexmedetomidine to a patient that is intubated (p. 4, if4).
`
`Dependent claim 9 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to disclose or suggest a phannaceutical composition comprising dexmedetomidine or a
`
`phannaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL that
`
`is formulated as a ready to use liquid for parenteral administration to a subject and that is
`
`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 9 which is directed to a dexmedetomidine composition at a
`
`NY02:758299.2
`
`8
`
`Hospira, Exh. 2007, p. 8
`
`

`
`PATENT
`077350.0359
`
`concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass container that is
`
`formulated as a ready to use liquid for parenteral 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).
`
`j.
`
`Dependent Claim 10
`
`The method of claim 1, wherein the patient is critically ill.
`
`Dependent claim 10 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to suggest or describe administration of a composition comprising dexmedetomidine
`
`to a patient that is critically ill.
`
`Additionally, dependent claim 10 is not anticipated by the Precedex™ label because the
`
`Precedex™ label 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 for parenteral administration to a
`
`subject and that is disposed within a sealed glass container. The Precedex™ label discloses
`
`dexmedetornidine hydrochloride at a concentration of 100 µg/rnL disposed within 2 mL clear
`
`glass vials and 2 mL ampoules. In contrast to claim 12 which is directed to a dexmedetomidine
`
`composition at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container that is formulated as a ready to use liquid for parenteral 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-i16).
`
`k.
`
`Dependent Claim 11
`
`The method of claim 1, wherein the composition is administered by an intravenous
`
`infusion.
`
`The Precedex™ label describes administration of a composition comprising
`
`dexmedetomidine to a patient by an intravenous infusion (p. 6, if4; p. 7, if3-if5; p. 12, if2-if4).
`
`Dependent claim 11 is not anticipated by the Precedex™ label because the Precedex™
`
`label 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 for parenteral administration to a subject and that is
`
`NY02:758299.2
`
`9
`
`Hospira, Exh. 2007, p. 9
`
`

`
`PATENT
`077350.0359
`
`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 11 which is directed to a dexmedetomidine composition at a
`
`concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass container that is
`
`formulated as a ready to use liquid for parenteral 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, il6-if8; p. 13, if5-if6).
`
`I.
`
`Dependent Claim 12
`
`The method of claim 1, wherein the composition is administered as an anxiolytic.
`
`The Precedex™ label discloses administration of a composition comprising
`
`dexmedetomidine as an anxiolytic (p. 4, if3).
`
`Dependent claim 12 is not anticipated by the Precedex™ label because the Precedex™
`
`label 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 for parenteral administration to a subject and that is
`
`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 12 which is directed to a dexmedetomidine composition at a
`
`concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass container that is
`
`formulated as a ready to use liquid for parenteral 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-if8; p. 13, iJ5-if6).
`
`m.
`
`Dependent Claim 13
`
`The method of claim 1, wherein the composition is administered as an adjunct to an
`
`anesthetic.
`
`The Precedex™ label describes administration of a composition comprising
`
`dexmedetomidine as an adjunct to an anesthetic. (p. 8, iJ4).
`
`Dependent claim 13 is not anticipated by the PrecedexTM label because the PrecedexTM
`
`label fails to disclose or suggest a pharmaceutical composition comprising dexmedetomidine or a
`
`NY02:758299.2
`
`10
`
`Hospira, Exh. 2007, p. 10
`
`

`
`PATENT
`077350.0359
`
`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 for parenteral administration to a subject and that is
`
`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 13 which is directed to a dexmedetomidine composition at a
`
`concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass container that is
`
`formulated as a ready to use liquid for parenteral 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-ifS; p. 13, if5-if6).
`
`n.
`
`Dependent Claim 14
`
`The method of claim 1, wherein the composition is administered as an analgesic.
`
`The Precedex™ label describes administration of a composition comprising
`
`dexmedetomidine as an analgesic. (p. 5, if2-if3, p. 6, i/2).
`
`Dependent claim 14 is not anticipated by the Precedex™ label because the Precedex™
`
`label 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 for parenteral administration to a subject and that is
`
`disposed within a sealed glass container. The Precedex™ label discloses dexmedetomidine
`
`hydrochloride at a concentration of I 00 µg/mL disposed within 2 mL clear glass vials and 2 mL
`
`ampoules. In contrast to claim 14 which is directed to a dexmedetomidine composition at a
`
`concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass container that is
`
`formulated as a ready to use liquid for parenteral 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-i/8; p. 13, if5-if6).
`
`o.
`
`Dependent Claim 15
`
`The method of claim 1, wherein the composition is administered as an anti-hypertensive
`
`agent.
`
`NY02:758299.2
`
`11
`
`Hospira, Exh. 2007, p. 11
`
`

`
`PATENT
`077350.0359
`
`Dependent claim 15 is not anticipated by the Precedex™ label because the Precedex™
`
`label fails to suggest or describe administration of a composition comprising dexmedetomidine
`
`as an anti-hypertensive agent.
`
`Additionally, dependent claim 15 is not anticipated by the Precedex™ label because the
`
`Precedex™ label 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 for parenteral administration to a
`
`subject and that is 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 15 which is directed to a dexmedetomidine
`
`composition at a concentration of about 0.005 to about 50 µg/mL disposed within a sealed glass
`
`container that is formulated as a ready to use liquid for parenteral 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. 20110230534, published September 22, 2011 to Miyawaki et al.
`
`(" Miyawaki'').
`
`a.
`
`Independent Claim 1
`
`A method of providing sedation to a patient in need thereof, the method comprising
`
`Independent claim 1 is not anticipated by Miyawaki because Miyawaki fails to suggest or
`
`describe a method of providing sedation to a patient in need thereof.
`
`Additionally, independent claim 1 is not anticipated by Miyawaki because Miyawaki
`
`discloses a kit for local anesthesia including a local anesthetic agent, such as lidocaine, and a
`
`composition for local anesthesia, such as dexmedetomidine, as components of the kit, wherein an
`
`amount of the composition for local anesthesia may be mixed into the local anesthetic agent in
`
`advance of its use (p. 2, if24-29; p. 9, if 95). However, Miyawaki 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.
`
`NY02:758299.2
`
`12
`
`Hospira, Exh. 2007, p. 12
`
`

`
`PATENT
`077350.0359
`
`administering to the patient an effective amount of a composition, wherein the
`
`composition comprises dexmedetomidine or a pharmaceutically acceptable salt thereof
`
`Miyawaki discloses administering to a patient an effective amount of a composition,
`
`wherein the composition comprises dexmedetomidine or a pharmaceutically acceptable salt
`
`thereof (p. 2, if25; pp. 2-3, if37; p. 3, if43; p. 4, if56; p. 4, if58; p. 5, if67-if68; pp. 7-8, i/78-81).
`
`Independent claim 1 is not anticipated by Miyawaki because Miyawaki discloses a kit for
`
`local anesthesia including a local anesthetic agent, such as lidocaine, and a composition for local
`
`anesthesia, such as dexmedetomidine, as components of the kit, wherein an amount of the
`
`composition for local anesthesia may be mixed into the local anesthetic agent in advance of its
`
`use {p. 2, i/24-29; p. 9, if 95). However, Miyawaki 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.
`
`ata concentration of about 0.005 to about 50 µg/mL,
`
`Miyawaki discloses a pharmaceutical composition comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of 4x 10-6 M, 4xl 0-7 M, 4x 1 ff8 M, or
`4x10-9 M (p. 56, if56). Such concentrations correspond to about 0.8 µg/mL, 0.08 µg/mL, 0.008
`
`µg/mL and 0.0008 µg/mL, respectively. Miyawaki also discloses a composition comprising
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of between
`lxl0-15 M and lx10-6 M (p. 2, if26; and Claim 2), which corresponds to about 2x10- 10 µg/mL and
`
`0.2 µg/mL, respectively.
`
`Independent claim 1 is not anticipated by Miyawaki because Miyawaki discloses a kit for
`
`local anesthesia including a local anesthetic agent, such as lidocaine, and a composition for local
`
`anesthesia, such as dexmedetomidine, as components of the kit, wherein an amount of the
`
`composition for local anesthesia may be mixed into the local anesthetic agent in advance of its
`
`use (p. 2, if24-29; p. 9, if 95). However, Miyawaki fails to disclose or suggest a pharmaceutical
`
`composition comprising dexmedetornidine 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.
`
`NY02:758299.2
`
`13
`
`Hospira, Exh. 2007, p. 13
`
`

`
`PATENT
`077350.0359
`
`wherein the composition is a ready to use liquid pharmaceutical composition for
`
`parenteral administration to the patient
`
`Miyawaki discloses a liquid pharmaceutical composition for parenteral administration to
`
`a patient (p. 2, i-f37; p. 3, if41; p. 4, i-f58 p. 5, i-f67-if68; pp. 7-8, i-f78-81).
`
`Independent claim 1