UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111788,076
`
`04/18/2007
`
`Michelle Renee Duncan
`
`19015-63
`
`4752
`
`04110/2009
`7590
`28221
`PA 1ENT DOCKET ADMINISTRATOR
`LOWENSTEIN SANDLER PC
`65 LIVINGSTON A VENUE
`ROSELAND, NJ 07068
`
`EXAMINER
`
`BECKHARDT, L YNDSEY MARIE
`
`ART UNIT
`
`PAPER NUMBER
`
`4121
`
`MAIL DATE
`
`DELIVERY MODE
`
`04/10/2009
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Sandoz Exhibit 1016 Page 1
`
`

`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/788,076
`
`Examiner
`
`DUNCAN ET AL.
`
`Art Unit
`
`4121
`LYNDSEY BECKHARDT
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE~ MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`1 )IZ! Responsive to communication(s) filed on 13 March 2009.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)[8J Claim(s) 1-30 and 40-44 is/are pending in the application.
`4a) Of the above claim(s) 6. 12.13.20 and 27 is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1-5. 7-11. 14-19. 21-26. 28-30 and 40-44 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some* c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17 .2(a)).
`*See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8Jinformation Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 03/13/2009. 02/13/2008. 0211112008.
`
`4) 0
`
`Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20090330
`
`Sandoz Exhibit 1016 Page 2
`
`

`
`Continuation Sheet (PTOL-326)
`
`Application No.
`
`2
`
`Sandoz Exhibit 1016 Page 3
`
`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 2
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`DETAILED ACTION
`
`Election/Restrictions
`
`1.
`
`Applicant's election without traverse of Group I, a pharmaceutical composition, in
`
`the reply filed on 03/13/2009 is acknowledged.
`
`Claims 31-39, drawn to the non-elected invention, are cancelled by the Applicant
`
`without prejudice.
`
`2.
`
`Applicant's election without traverse of dextrose as the tonicity agent without
`
`traverse in the reply filed on 03/13/2009 is acknowledged.
`
`3.
`
`Claims 6, 12-13, 20 and 27 are withdrawn from further consideration pursuant to
`
`37 CFR 1 .142(b) as being drawn to a nonelected species, there being no allowable
`
`generic or linking claim. Election was made without traverse in the reply filed on
`
`03/13/2009.
`
`Priority
`
`This application claims priority to provisional application 60/793,074, filing date
`
`04/18/2006. However, the provisional application 60/793,07 4, for which priority is
`
`claimed fails to provide adequate support under 35 U.S.C. 112 for claims 43 and 44 of
`
`this application since 60/793,074 does not disclose the container comprising
`
`copolyester, polyethylene or polyolefin. The effective filing date for claims 1-30 and 40-
`
`42 is 04/18/2006. The effective filing date for claims 43-44 is 04/18/2007. If applicant
`
`disagrees, applicant should present a detailed analysis as to why the claimed subject
`
`matter has clear support in the earlier priory application. Applicant is reminded that
`
`Sandoz Exhibit 1016 Page 4
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 3
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`such priority for the instant limitations requires written description and enablement under
`
`35 U.S.C. § 112, first paragraph.
`
`Information Disclosure Statement
`
`4.
`
`Applicants Information Disclose Statements, filed on 03/13/2009, 02/13/2008 and
`
`02/11/2008, have been considered. Please refer to Applicant's copy of the 1449
`
`submitted herein.
`
`Claim Rejections- 35 USC§ 103
`
`5.
`
`The following is a quotation of 35 U.S.C. 1 03(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`6.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under 35 U.S.C. 103(a) are summarized as follows:
`
`1.
`2.
`3.
`4.
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
`
`7.
`
`Claims 1-5, 7-8, 10, 14, 17-19, 21-22, 24-26 and 28-29 rejected under 35 U.S.C.
`
`103(a) as being unpatentable over US 5,164,405 (patent date 11/17/1992).
`
`The '405 patent teaches a stable pharmaceutical composition containing
`
`nicardipine hydrochloride, a non-chloride isotonicity agent, a buffering agent and a
`
`pharmaceutically acceptable aqueous vehicle for parenteral administration (abstract).
`
`Sandoz Exhibit 1016 Page 5
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 4
`
`The invention is a pharmaceutical composition suitable for parenteral administration to
`
`mammals and useful in the treatment of disease conditions that may be alleviated by
`
`the administration of calcium channel blocking agents (column 2, lines 43-49). The
`
`pharmaceutical composition comprises: (a) a therapeutically effective amount of
`
`nicardipine hydrochloride, (b) a physiologically and pharmaceutically acceptable non-
`
`chloride compound effective to render the pharmaceutical composition isotonic, (b) a
`
`physiologically and pharmaceutically acceptable buffer in an amount effective to
`
`maintain the pH of the composition at about 3.0 to about 4.5, and a pharmaceutically
`
`acceptable aqueous vehicle comprising at least a major proportion of water (column 2,
`
`lines 50-50). This is applicable to claim 1, 2 and 17. The physiologically and
`
`pharmaceutically acceptable non-chloride compound used to render the pharmaceutical
`
`composition isotonic preferably may be selected from monohydric and polyhydric
`
`compounds (column 3, lines 53-57). Preferably the non-chloride compound may be
`
`selected from the group of polyhydric compounds comprising saccharides and non-
`
`saccharide polyhydric compounds. Suitable saccharides include sorbitol mannitol,
`
`dextrose and glucose (column 3, line 64 through column 4, line 2). This is applicable to
`
`claims 4-5, 19 and 26. Most preferably, the non-chloride compound, used as a
`
`compound is a saccharide compound. Especially preferred is sorbitol in the amount of
`
`about 48 m/ml to about 50 mg/ml of aqueous vehicle (column 4, lines 4-1 0). The control
`
`of pH of the formulation is also essential to maintain the aqueous solubility of the
`
`nicardipine salts to a sufficient extent that the therapeutically desirable dose strengths
`
`can be manufactured and are physically stable, i.e. do not give evidence of
`
`Sandoz Exhibit 1016 Page 6
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 5
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`precipitation. Maintenance of the necessary pH range can be best controlled by the use
`
`of a suitable buffer system (column 4, lines 25-32). The pharmaceutically effective
`
`buffer may be selected from any of the buffers that are effective to maintain the pH in
`
`the range of about 3.0-4.5. Most preferably, the buffer is citrate or acetate buffer, for
`
`example citric acid plus sodium hydroxide in appropriate proportions which will maintain
`
`the pH at about 3.5-4.5 (column 4, lines 33-46). This is applicable to claim 7, 14, 21
`
`and 28. The pharmaceutically acceptable carrier in the pharmaceutical composition
`
`may be selected from 100% of water (water for injection) or an aqueous system (that is
`
`an aqueous vehicle) comprising at least a major proportion of water (column 4, lines 63-
`
`69). By "major proportion" is meant at least 51% of the aqueous vehicle is water and
`
`the balance comprising one or more pharmaceutically acceptable non-aqueous, water
`
`miscible co-solvents such as ethanol and glycols (column 5, lines 1-5). This is
`
`applicable to claim 8, 22 and 29. A composition is taught to containing an effective
`
`amount of nicardipine hydrochloride in from about 0.5 mg/ml to about 10 mg/ml of
`
`aqueous vehicle and the aqueous solvent is water (column 11, claim 4 ). Stability data
`
`shows excellent stability for up to 3 years at 25° C., with no significant loss of potency or
`
`change in solution pH (table 7). This is applicable to claim 17 and 24.
`
`Table 2 gives an example of a composition (1 mg/ml) where Nicardipine HCL is
`
`present in an amount of 1.0 mg, sorbitol is present at 48.9 mg, sodium hydroxide is at
`
`0.09 mg, citric acid is at 0.525 mg and water is qs ad 1.0 ml (column 7, table 2).
`
`Sorbitol is taught to be a tonicity agent above, and dextrose is taught to also be a
`
`preferred tonicity agent. "[W]here the general conditions of a claim are disclosed in the
`
`Sandoz Exhibit 1016 Page 7
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 6
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`prior art, it is not inventive to discover the optimum or workable ranges by routine
`
`experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`The amount Nicardipine HCL and citric acid present in the instant application is not
`
`outside of the workable ranges by routine experimentation of the amounts found in
`
`Table 2. This is applicable to claims 3, 10, 18 and 25.
`
`While the '405 patent does not teach all of the elements in a single composition,
`
`it does provide motivation to combine all of the elements by listing the component
`
`associated with terms like 'preferably used' and 'may also include'.
`
`Therefore it would have been prima facie obvious to one of ordinary skill in the
`
`art at the time the invention was made to combine any elements listed in the '405
`
`publication to make the biocompatible coating that is taught by the '405 publication
`
`because of the use of term like 'preferably used' and 'may also include' by the '405
`
`publication.
`
`8.
`
`Claim 15 is rejected under 35 U.S.C. 103(a) as being unpatentable over US
`
`5,164,405 (patent date 11/17/1992) as applied to claims 1-5, 7-8, 10, 14, 17-19, 21-22,
`
`24-26 and 28-29 above, and further in view of WO 2001/07086 (publication date:
`
`02/01/2001 ).
`
`The '405 patent teaches a stable pharmaceutical composition containing
`
`nicardipine hydrochloride, a non-chloride isotonicity agent, a buffering agent and a
`
`pharmaceutically acceptable aqueous vehicle for parenteral administration. The
`
`pharmaceutically effective buffer may be selected from any of the buffers that are
`
`effective to maintain the pH in the range of about 3.0-4.5. Most preferably, the buffer is
`
`Sandoz Exhibit 1016 Page 8
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 7
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`citrate or acetate buffer, for example citric acid plus sodium hydroxide in appropriate
`
`proportions which will maintain the pH at about 3.5-4.5
`
`The '405 patent does not teach the osmolality of this composition to be from
`
`about 250 to 350 mOsm/kg.
`
`The '086 publication teaches sodium chloride as being useful for adjusting the
`
`osmolality of the formulation to achieve the desired resulting osmolality. Particularly
`
`preferred osmolalities for parenteral administration of the disclosed compositions are in
`
`the range of about 270 to about 330 mOsm/kg. The optimal osmolality for parenterally
`
`administered compositions, particularly injectable, is approximately 300 [m]Osm/kg
`
`(page 23, lines 5-14 ). This is applicable to claim 15.
`
`Therefore it would have been prima facie obvious to one of ordinary skill in the
`
`art at the time the invention was made to use sodium chloride as taught by the '086
`
`publication in the pharmaceutical composition taught for injection by the '405 patent
`
`because the optimal osmolality for parenterally administered compositions is
`
`approximately 300 mOsm/kg as taught by the '086 publication.
`
`9.
`
`Claims 16, 40-41 and 43-44 are rejected under 35 U.S.C. 1 03(a) as being
`
`unpatentable over US 5,164,405 (patent date 11/17/1992) as applied to claims 1-5, 7-8,
`
`10, 14, 17-19,21-22, 24-26 and 28-29 above, and further in view of Solutions to Health
`
`Care Waste: Life-Cycle Thinking and "Green" Purchasing (publication date: 04/2001 ),
`
`hereafter referred to as Kaiser.
`
`The '405 patent teaches a stable pharmaceutical composition containing
`
`nicardipine hydrochloride, a non-chloride isotonicity agent, a buffering agent and a
`
`Sandoz Exhibit 1016 Page 9
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 8
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`pharmaceutically acceptable aqueous vehicle for parenteral administration. The
`
`pharmaceutically effective buffer may be selected from any of the buffers that are
`
`effective to maintain the pH in the range of about 3.0-4.5. Most preferably, the buffer is
`
`citrate or acetate buffer, for example citric acid plus sodium hydroxide in appropriate
`
`proportions which will maintain the pH at about 3.5-4.5, which is applicable to claim 41.
`
`Table 2 gives an example of a composition (1 mg/ml) where Nicardipine HCL is
`
`present in an amount of 1.0 mg, sorbitol is present at 48.9 mg, sodium hydroxide is at
`
`0.09 mg, citric acid is at 0.525 mg and water is qs ad 1.0 ml (column 7, table 2).
`
`Sorbitol is taught to be a tonicity agent above, and dextrose is taught to also be a
`
`preferred tonicity agent. "[W]here the general conditions of a claim are disclosed in the
`
`prior art, it is not inventive to discover the optimum or workable ranges by routine
`
`experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`The amount Nicardipine HCL and citric acid present in the instant application is not
`
`outside of the workable ranges by routine experimentation of the amounts found in
`
`Table 2. Stability data shows excellent stability for up to 3 years at 25° C., with no
`
`significant loss of potency or change in solution pH (table 7). This is applicable to
`
`claims 40 and 44.
`
`The '405 patent does not teach the aqueous solution contained in a
`
`pharmaceutically acceptable container such that the solution does not come into contact
`
`with polar polymers. The container is not taught to be an intravenous bag or bottle.
`
`The container is also not taught to comprise a co polyester, polyethylene or polyolefin.
`
`Sandoz Exhibit 1016 Page 10
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 9
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`Kaiser teaches one important caveat of the purchasing approach is that
`
`alternative products must clearly be shown to have superior environmental
`
`performance. For example, a polyolefin intravenous (IV) bag does not contain chlorine,
`
`so it has less potential to produce dioxins through incineration than an IV bag containing
`
`polyvinyl chloride (PVC). It is also imperative that the alternative product has equal or
`
`superior clinical performance. For instance, a recent comparison of polyolefin and PVC
`
`platelet storage containers showed "no consistent differences" in the parameters
`
`observed (page 2, last paragraph). This is applicable to claims 16, 40-41 and 43-44
`
`Therefore it would have been prima facie obvious to one of ordinary skill in the
`
`art at the time the invention was made to use polyolefin intravenous bags as taught by
`
`Kaiser for administering the pharmaceutical composition containing nicardipine
`
`hydrochloride for parenteral administration as taught by the '405 patent because it will
`
`have less environmental impact and has shown no consistent differences when
`
`compared to PVC platelet storage containers as taught by Kaiser.
`
`10.
`
`Claims 9, 11, 23, 30 and 42 are rejected under 35 U .S.C. 1 03(a) as being
`
`unpatentable over US 5,164,405 (patent date 11/17/1992) and Kaiser (publication date:
`
`04/2001) as applied to claims 1-5, 7-8, 10, 14, 16-22, 24-26, 28-29, 40-41 and 43-44
`
`above, and further in view of US 4,880,823 (patent date: 11 /14/1989).
`
`The combination of references teaches a stable pharmaceutical composition
`
`containing nicardipine hydrochloride, a non-chloride isotonicity agent, a buffering agent
`
`and a pharmaceutically acceptable aqueous vehicle for parenteral administration. The
`
`pharmaceutically effective buffer may be selected from any of the buffers that are
`
`Sandoz Exhibit 1016 Page 11
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`

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`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 10
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`effective to maintain the pH in the range of about 3.0-4.5. Most preferably, the buffer is
`
`citrate or acetate buffer, for example citric acid plus sodium hydroxide in appropriate
`
`proportions which will maintain the pH at about 3.5-4.5.
`
`Table 2 gives an example of a composition (1 mg/ml) where Nicardipine HCL is
`
`present in an amount of 1.0 mg, sorbitol is present at 48.9 mg, sodium hydroxide is at
`
`0.09 mg, citric acid is at 0.525 mg and water is qs ad 1.0 ml (column 7, table 2).
`
`Sorbitol is taught to be a tonicity agent above, and dextrose is taught to also be a
`
`preferred tonicity agent. "[W]here the general conditions of a claim are disclosed in the
`
`prior art, it is not inventive to discover the optimum or workable ranges by routine
`
`experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`The amount Nicardipine HCL and citric acid present in the instant application is not
`
`outside of the workable ranges by routine experimentation of the amounts found in
`
`Table 2. Stability data shows excellent stability for up to 3 years at 25° C., with no
`
`significant loss of potency or change in solution pH (table 7). The combination of
`
`references also teaches the use of polyolefin intravenous (IV) bags for administration of
`
`the parenteral administered compound.
`
`The combination of references does not teach sorbitol as a cosolvent in the
`
`range of 1.92 mg/ml to about 3.84 mg/ml.
`
`The '823 patent teaches an injectable composition of nicardipine hydrochloride
`
`comprising an aqueous nicardipine hydrochloride solution containing 2-7 w/v% of
`
`polyhydric alcohol. This injectable composition can maintain its desired concentration
`
`and can be stably stored for a long period of time (abstract). It has been discovered
`
`Sandoz Exhibit 1016 Page 12
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`

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`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 11
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`that when nicardipine chloride is dissolved in water together with 2 to 7 WN% of a
`
`polyhydric alcohol, a stable aqueous solution of nicardipine hydrochloride is
`
`unexpectedly obtained and based on the discovery; the invention has been attained
`
`(column 1, lines 45-51 ). As the polyhydric alcohol for use in this invention is sorbitol,
`
`mannitol, xylitol, propylene glycol, glycerol and inositol, etc (column 2, lines 5-1 0). This
`
`is applicable to claims 9, 23 and 30. In addition, a certain polyhydric alcohol may show
`
`the insufficient isotonization by the use of about 2 WN% and in such a case, the
`
`isotonization of the injectable composition may be controlled by using other isotonizing
`
`agent (column 2, lines 1 0-16). Example 1 states about 2 liters of distilled water was
`
`heated to 50° to 60° C and 2.5 g of nicardipine hydrochloride and 125 g of sorbitol were
`
`dissolved therein with stirring. After cooling the solution (pH about 4.5) thus obtained to
`
`room temperature, the pH thereof was adjusted to 3.5 using 0.1 N hydrochloric acid.
`
`Then, when the whole volume thereof was adjusted to 2.5 liters by the addition of
`
`distilled water and after filtering the solution 5 ml of each of the solution was filled in
`
`each light-resistant brown ampoule (column 4, example 1 ).
`
`In example 7, the same
`
`procedure was used as example 1, but 50 g of sorbitol was used in place of the 125 mg
`
`used in example 1 (column 4, example 7). The 50 g sorbitol in 2.5 L solution is 20
`
`mg/ml. The concentration of nicardipine hydrochloride present in this example is 2.5 g
`
`nicardipine hydrochloride in 2.5 L solution is 1 mg/ml. This corresponds to a ratio of 1
`
`mg/ml nicardipine to 20 mg/ml sorbitol.
`
`Sandoz Exhibit 1016 Page 13
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 12
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`The instant application contains nicardipine from about 0.1 to 0.4 mg/ml. If the
`
`ratio of nicardipine to sorbitol taught above is used, sorbitol should be present in the
`
`mixture from about 2 to about 8 mg/ml. This is applicable to claims 11 and 42.
`
`Also use of 20 mg/ml of sorbitol stated by the '823 patent is not outside of routine
`
`optimization conditions to the 1 to 4 mg/ml sorbitol that is claimed in the instant
`
`application. "[W]here the general conditions of a claim are disclosed in the prior art, it is
`
`not inventive to discover the optimum or workable ranges by routine experimentation."
`
`In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955). The smaller amount
`
`of drug in water would require less sorbitol to help stabilize the system.
`
`Also sorbitol and dextrose are both taught to be isotonizing agents. "It is prima
`
`facie obvious to combine two compositions each of which is taught by the prior art to be
`
`useful for the same purpose, in order to form a third composition to be used for the very
`
`same purpose .... [T]he idea of combining them flows logically from their having been
`
`individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ
`
`1069, 1072 (CCPA 1980). Once the components in the formulation have been decided,
`
`it would be routine to optimize for stability and solubility, which would have given the
`
`required amounts of the claims.
`
`Therefore it would be prima facie obvious to one of ordinary skill in the art at the
`
`time the invention was made to use sorbitol as a the polyhydric alcohol dissolved with
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`water as taught by the '823 patent in the pharmaceutical composition containing
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`nicardipine hydrochloride for parenteral administration as taught by the '405 patent
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`Sandoz Exhibit 1016 Page 14
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`

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`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 13
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`because nicardipine chloride dissolved in water together with polyhydric alcohol creates
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`a stable aqueous solution as taught by the '823 publication.
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`Double Patenting
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`Non-statutory
`
`The nonstatutory double patenting rejection is based on a judicially created
`11.
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`and to prevent possible harassment by multiple assignees. A nonstatutory
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`are not identical, but at least one examined application claim is not patentably distinct
`from the reference claim(s) because the examined application claim is either anticipated
`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
`F.3d 1428,46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046,29
`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`1985); In re VanOrnum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422
`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`double patenting ground provided the conflicting application or patent either is shown to
`be commonly owned with this application, or claims an invention made as a result of
`activities undertaken within the scope of a joint research agreement.
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`37 CFR 3.73(b).
`
`12.
`
`Claims 1, 3-5, 7-9 are provisionally rejected on the ground of nonstatutory
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`obviousness-type double patenting as being unpatentable over claims 1, 4, 7-8 and 11-
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`12 of copending Application No. 11/737,067 in view of Photostability studies on
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`nicardipine-cyclodextrin complexes by capillary electrophoresis (Published: 2004),
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`hereafter referred to as Pomponio. Although the conflicting claims are not identical,
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`they are not patentably distinct from each other because the copending claims recite a
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`salt of nicardipine as one embodiment; the pH range is overlapping, but with slightly
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`Sandoz Exhibit 1016 Page 15
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 14
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`different end points of the range, the copending claims recite a higher nicardipine
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`concentration than the instant claims and a tonicity agent is present. It would be
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`obvious to optimize the pH and nicardipine amounts of both claims sets, and citrate is
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`an art recognized buffer suitable for nicardipine formulations, which would give the
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`same compositions as the elected embodiment of the instant claims. The motivation to
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`optimize the pH and amount of nicardipine would have been the routine optimization of
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`conditions. The '067 application also includes cyclodextrin in the pharmaceutical
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`composition. Pomponio teaches Nicardipine-cyclodextrin solid systems to find favor in
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`preventing drug photodegradation when 13-cyclodextrin is used (abstract). Therefore it
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`would have been prima facie obvious to one of ordinary skill in the art at the time the
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`invention was made to use a complex of nicardipine and a-cyclodextrin as taught by
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`Pomponio in the pharmaceutical composition taught by the instant claims to protect
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`nicadripine from photodegradation as taught by Pomponio.
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`This is a provisional obviousness-type double patenting rejection because the
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`conflicting claims have not in fact been patented.
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`Conclusion
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`No claims are allowed.
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to L YNDSEY BECKHARDT whose telephone number is
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`(571 )270-7676. The examiner can normally be reached on Monday to Friday 8:00am
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`to 5:00 pm EST.
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`Sandoz Exhibit 1016 Page 16
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`

`
`Application/Control Number: 11/788,076
`Art Unit: 4121
`
`Page 15
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Patrick Nolan can be reached on 571-272-084 7. The fax phone number for
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`the organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`LMB
`
`/Patrick J. Nolan/
`Supervisory Patent Examiner, Art Unit 4121
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`Sandoz Exhibit 1016 Page 17