`
`UNITED STATES PATENT AND TRADEMARK OEEICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.0 Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto gov
`
`12/971,084
`
`12/17/2010
`
`Michelle Renee Duncan
`
`19015-221
`
`7283
`
`
`
`
`
`11/30/2012
`7590
`28221
`pAmNT DOCKET ADMINISTRATOR
`LOWENSTEIN S ANDLER PC
`65 LIVINGSTON AVENUE
`
`ROSELAND, NJ 07068
`
`BECKHARDT. LYNDSEY MARIE
`
`1613
`
`MAIL DATE
`
`11/30/2012
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`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-9OA (Rev. 04/07)
`
`Sandoz
`
`Exhibit1016
`
`Page1
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`Sandoz Exhibit 1016 Page 1
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`

`

`
`Application No.
`Applicant(s)
`
`Office Action Summary
`
`
`
`12/971,084
`
`DUNCAN ET AL.
`
`Examiner
`LYNDSEY BECKHARDT
`
`Art Unit
`1613
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period tor Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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 CFR1. 136(a).
`In no event however may a reply be timely filed
`after SIX () MONTHS from the mailing date of this communication.
`If NO period for repiy is specified above, the maximum statutory period wili apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Faiiure to repiy within the set or extended period for replywili, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received bythe Office later than three months afterthe mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR1.704(b).
`
`Status
`
`DIX Responsive to communication(s) filed on 17 December 2010.
`
`2a)l:l This action is FINAL.
`
`2b)IZ This action is non-final.
`
`3)I:| An election was made by the applicant in response to a restriction requirement set forth during the interview on
`_; the restriction requirement and election have been incorporated into this action.
`
`4)|:| 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 Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`
`
` Attachment(s)
`
`Disposition of Claims
`
`5)IZ Claim(s) 40—51is/are pending in the application.
`5a) Of the above Claim(s) _ is/are withdrawn from consideration.
`
`6)I:| Claim(s)_ is/are allowed.
`
`DIE Claim(s)4_1si/are rejected.
`
`8)I:I Claim(s)_ is/are objected to.
`
`9)I:| Claim((s)
`are subject to restriction and/or election requirement.
`
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway
`program at a participating intellectual property office for the corresponding application. For more information, please see
`
`hits:- :ri'fwww. usr‘to. nay/Laertslam' events/
`h/indexfs orsend an inquiry to PPeredback us rocov.
`
`Application Papers
`
`10)|:| The specification is objected to by the Examiner.
`11)X| The drawing(s) filed on 17December 2010 is/are: a)IZI accepted or b)I:l 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).
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`b)|:l Some * c)I:I None of:
`a)I:| AII
`1.I:| Certified copies of the priority documents have been received.
`
`2.|:| Certified copies of the priority documents have been received in Application No. _
`
`3.I:l 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.
`
`1) IX Notice of References Cited (PTO-892)
`
`2) E Information Disclosure Statement(s) (PTO/SB/OS)
`Paper No(s)/Mai| Date (42 03/30/2012. 04/23/2012.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 09-12)
`
`3) I] Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`4) CI Other:
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20121128
`
`Sandoz
`
`Exhibit1016
`
`Page2
`
`Sandoz Exhibit 1016 Page 2
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 2
`
`DETAILED ACTION
`
`Claims 40-51 are currently pending and under examination.
`
`Priority
`
`The instant application is a continuation of application 12/645,169, filed
`
`12/22/2009, which is a continuation of application 12/407,557, filed 03/19/2009, which is
`
`a divisional of application 11/788,076, filed 04/18/2007, which claims priority to
`
`provisional application 60/793,074, filing date 04/18/2006. However, the provisional
`
`application 60/793,074, for which priority is claimed fails to provide adequate support
`
`under 35 U.S.C. 112 for claims 45 and 47-51 of this application since 60/793,074 does
`
`not disclose the container comprising copolyester, polyethylene or polyolefin or not
`
`coming into contact with polar polymers. The effective filing date for claims 40-44 and
`
`46 is 04/18/2006. The effective filing date for claims 45 and 47-51 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 such priority for the instant limitations requires written description and enablement
`
`under 35 U.S.C. § 112, first paragraph.
`
`Information Disclosure Statement
`
`Applicant’s Informational Disclosure Statement, filed on 4/23/2012 and (4) 03/30/2012
`
`has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
`
`Oath/Declaration
`
`The oath or declaration, having the signatures of all inventors, received on
`
`12/17/2010 is in compliance with 37 CFR 1.63.
`
`Sandoz
`
`Exhibit1016
`
`Page3
`
`Sandoz Exhibit 1016 Page 3
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 3
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
`
`Claims 40, 42-44 and 46 are rejected under 35 U.S.C. 102(b) as being
`
`anticipated by Baaske (Applicant provided) as evidenced by PDL Biopharma
`
`(Applicant provided) and VislV (VislV, Dextrose Injection Solution, (04/2007), pgs.
`
`1-6).
`
`Regarding claims 40, the limitation of a method for treating acute elevations of
`
`blood pressure in a human subject in need thereof, said method comprising parenterally
`
`administering a composition comprising from about 0.1 to 0.4 mg/mL nicardipine or a
`
`pharmaceutically acceptable salt thereof; a tonicity agent and a buffer; wherein the
`
`composition requires no dilution before administration and has a pH from about 3.6 to
`
`about 4.7, the composition stored in a container is met by Baaske teaching nicardipine
`
`HCI being used to treat hypertension and administered in as an IV solution (page 1701,
`
`first column, first paragraph) being diluted to a concentration of 0.05 to 0.5 mg/ml and
`
`administered in a dextrose injection comprising citrate (abstract) wherein the
`
`composition is taught to have a pH of between 3.4 and 5.9 (page 1703, second column,
`
`second paragraph). The dilution is taught to be stable for up to seven days in a glass
`
`container (abstract).
`
`Sandoz
`
`Exhibit1016
`
`Page4
`
`Sandoz Exhibit 1016 Page 4
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 4
`
`Regarding claim 42, the limitations of a method of treating acute elevations of
`
`blood pressure in a human subject in need thereof, said method comprising parenterally
`
`administering to a subject in need thereof a premixed aqueous solution with a pH from
`
`about 3.6 to about 4.7 comprising from about 0.1 to 0.4 mg/ml nicardipine
`
`hydrochloride; a tonicity agent selected from a group which includes about 4.5 to about
`
`5% dextrose and from about 0.01 to about 0.1 mg/mL citric acid; the aqueous solution
`
`contained in a pharmaceutically acceptable container is met by Baaske teaching
`
`nicardipine HCI being used to treat hypertension and administered in as an IV solution
`
`(page 1701, first column, first paragraph) being diluted to a concentration of 0.05 to 0.5
`
`mg/ml and administered in a dextrose injection at 5% comprising citrate (abstract)
`
`wherein the composition is taught to have a pH of between 3.4 and 5.9 (page 1703,
`
`second column, second paragraph). The dilution is taught to be stable for up to seven
`
`days in a glass container (abstract). PDL Biopharma evidences that the commercially
`
`available nicardipine hydrochloride composition comprises 2.5 mg nicardipine
`
`hydrochloride and 0.525 mg citric acid monohydrate with a pH of 3.5 (page 1, third
`
`paragraph). The dilution of the commercially available composition taught by Baaske
`
`(page 1701 first column, first paragraph) evidenced to initially comprise 0.525 mg citric
`
`acid would contain between 0.105 and 0.0105 mg citric acid upon dilution to obtain the
`
`concentration of nicardipine from the concentrate desired by Baaske (abstract). 2.5 mg
`
`nicardipine to between 0.5 and 0.05 mg nicardipine is a 5:1 or 50:1 dilution. The same
`
`dilution to the mg of citric acid obtains a concentration of 0.105 or 0.0105 mg citric acid
`
`in the dilute formulation.
`
`Sandoz
`
`Exhibit1016
`
`Page5
`
`Sandoz Exhibit 1016 Page 5
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 5
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`Regarding claims 43, the limitation of further comprising at least one pH adjuster
`
`selected from the group consisting of hydrochloric acid, sodium hydroxide and a mixture
`
`thereof is met by Baaske teaching adjustment of the pH with sodium hydroxide (page
`
`1701, first column, first paragraph).
`
`Regarding claims 44, the limitation of further comprising from about 1 mg/ml to
`
`about 4 mg/ml sorbitol is met by Baaske teaching sorbitol in the concentrate solution
`
`(page 1701, first column, first paragraph). PDL Biopharma evidences the amount of
`
`sorbitol in the commercially available composition is 48.00mg (page 1, third paragraph).
`
`Dilution of the composition as taught by Baaske would lead to a final sorbitol
`
`concentration between 9.6 mg and 0.96 mg (dilution calculations discussed above in
`
`regards to citric acid).
`
`Regarding claim 46, the limitations regarding pH, concentration of nicardipine
`
`HCI and citric acid as well as no containing a polar polymer are addressed above in
`
`regards to claim 40. Claim 46 additionally requires the tonicity agent being from about
`
`46 to about 50 mg/mL dextrose. Baaske teaches dilution of the concentrate form of
`
`nicardipine with a 5% dextrose solution. VisIV evidences that a 5% dextrose solution
`
`(page 1, first paragraph) comprises 5 grams dextrose in 100 milliliters (page 5, first
`
`paragraph) which equates to 50 mg/ml dextrose.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`Sandoz
`
`Exhibit1016
`
`Page6
`
`Sandoz Exhibit 1016 Page 6
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 6
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`(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.
`
`The factual inquiries set forth in Graham v. John Deere 00., 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.
`
`This application currently names joint inventors.
`
`In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
`
`the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of 35 U.S.C. 103(0) and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`Claims 40-51 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over Baaske, Hersey (Hersey, Shannon et al., Anesth Analg; 84, (1997), pgs. 1239-
`
`44), Varon (Varon, Joseph, et al., Internet Scientific Publications (10/1996), pgs. 1-
`
`12) and Zeidler (Zeidler, C., Compatibility of various drugs used in intensive care
`
`medicine in polyethylene, PVC and glass infusion containers, European Hospital
`
`Sandoz
`
`Exhibit1016
`
`Page7
`
`Sandoz Exhibit 1016 Page 7
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 7
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`Pharmacy, 5(3), (Sep. 1999), pgs. 106-110) as evidenced PDL Biopharma and
`
`VislV.
`
`Regarding claims 40-41, the limitation of a method for treating acute elevations of
`
`blood pressure in a human subject in need thereof, said method comprising parenterally
`
`administering a composition comprising from about 0.1 to 0.4 mg/mL nicardipine or a
`
`pharmaceutically acceptable salt thereof; a tonicity agent and a buffer; wherein the
`
`composition requires no dilution before administration and has a pH from about 3.6 to
`
`about 4.7, the composition stored in a container is met by Baaske teaching nicardipine
`
`HCI being used to treat hypertension and administered in as an IV solution (page 1701,
`
`first column, first paragraph) being diluted to a concentration of 0.05 to 0.5 mg/ml and
`
`administered in a dextrose injection comprising citrate (abstract) wherein the
`
`composition is taught to have a pH of between 3.4 and 5.9 (page 1703, second column,
`
`second paragraph). The dilution is taught to be stable for up to seven days in a glass
`
`container (abstract).
`
`Regarding claim 42, 47 and 51, the limitations of a method of treating acute
`
`elevations of blood pressure in a human subject in need thereof, said method
`
`comprising parenterally administering to a subject in need thereof a premixed aqueous
`
`solution with a pH from about 3.6 to about 4.7 comprising from about 0.1 to 0.4 mg/ml
`
`nicardipine hydrochloride; a tonicity agent selected from a group which includes about
`
`4.5 to about 5% dextrose and from about 0.01 to about 0.1 mg/mL citric acid; the
`
`aqueous solution contained in a pharmaceutically acceptable container is met by
`
`Baaske teaching nicardipine HCI being used to treat hypertension and administered in
`
`Sandoz
`
`Exhibit1016
`
`Page8
`
`Sandoz Exhibit 1016 Page 8
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 8
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`as an IV solution (page 1701, first column, first paragraph) being diluted to a
`
`concentration of 0.05 to 0.5 mg/ml and administered in a dextrose injection at 5%
`
`comprising citrate (abstract) wherein the composition is taught to have a pH of between
`
`3.4 and 5.9 (page 1703, second column, second paragraph). The dilution is taught to
`
`be stable for up to seven days in a glass container (abstract). PDL Biopharma
`
`evidences that the commercially available nicardipine hydrochloride composition
`
`comprises 2.5 mg nicardipine hydrochloride and 0.525 mg citric acid monohydrate with
`
`a pH of 3.5 (page 1, third paragraph). The dilution of the commercially available
`
`composition taught by Baaske (page 1701 first column, first paragraph) evidenced to
`
`initially comprise 0.525 mg citric acid would contain between 0.105 and 0.0105 mg citric
`
`acid upon dilution to obtain the concentration of nicardipine from the concentrate
`
`desired by Baaske (abstract). 2.5 mg nicardipine to between 0.5 and 0.05 mg
`
`nicardipine is a 5:1 or 50:1 dilution. The same dilution to the mg of citric acid obtains a
`
`concentration of 0.105 or 0.0105 mg citric acid in the dilute formulation.
`
`Regarding claims 43 and 48, the limitation of further comprising at least one pH
`
`adjuster selected form the group consisting of hydrochloric acid, sodium hydroxide and
`
`a mixture thereof is met by Baaske teaching adjustment of the pH with sodium
`
`hydroxide (page 1701, first column, first paragraph).
`
`Regarding claims 44 and 49, the limitation of further comprising from about 1
`
`mg/ml to about 4 mg/ml sorbitol is met by Baaske teaching sorbitol in the concentrate
`
`solution (page 1701, first column, first paragraph). PDL Biopharma evidences the
`
`amount of sorbitol in the commercially available composition is 48.00mg (page 1, third
`
`Sandoz
`
`Exhibit1016
`
`Page9
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`Sandoz Exhibit 1016 Page 9
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 9
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`paragraph). Dilution of the composition as taught by Baaske would lead to a final
`
`sorbitol concentration between 9.6 mg and 0.96 mg (dilution calculations discussed
`
`above in regards to citric acid).
`
`Regarding claim 46, the limitations regarding pH, concentration of nicardipine
`
`HCI and citric acid as well as no containing a polar polymer are addressed above in
`
`regards to claim 40. Claim 46 additionally requires the tonicity agent being from about
`
`46 to about 50 mg/mL dextrose. Baaske teaches dilution of the concentrate form of
`
`nicardipine with a 5% dextrose solution. VisIV evidences that a 5% dextrose solution
`
`(page 1, first paragraph) comprises 5 grams dextrose in 100 milliliters (page 5, first
`
`paragraph) which equates to 50 mg/ml dextrose.
`
`Baaske does not ipsis verbis teach a method of inducing hypotension.
`
`Baaske does not ipsis verbis teach the container comprises copolyester,
`
`polyethylene or polyolefin (claims 45 and 50).
`
`Hersey teaches nicardipine being used to induce controlled hypotension in
`
`healthy adolescents undergoing spinal fusion wherein controlled hypotension is a well-
`
`established technique to decrease blood loss and improve surgical visibility during
`
`spinal fusion (abstract, page 1239, first column, first paragraph).
`
`Varon teaches hypertension is characterized by acute elevations in blood
`
`pressure (abstract) wherein nicardipine is FDA approved to treat severe hypertension
`
`(page 6, fourth paragraph).
`
`Zeidler teaches stability tests of number drugs in glass, PVC and polyethylene
`
`(PE) containers. The experiments were conducted in a standardized manner to
`
`Sandoz
`
`Exhibit1016
`
`Page10
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`Sandoz Exhibit 1016 Page 10
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 10
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`simulate the use of drugs under conditions of hospital practice using the most common
`
`basic infusion solutions (combination of NaCl and dextrose) and storage temperatures
`
`(4 degrees Celsius and 22 degrees Celsius). Samples were inspected for color and
`
`clarity and the pH was determined.
`
`It was demonstrated that PE and glass are suitable
`
`container for material whereas PVC reduces the concentration of certain drugs
`
`prepared in carrier solutions (abstract). PE and glass bottles showed basically the
`
`same properties for drug solution storage as far as their influence on the drug stability
`
`was concerned, while in contrast PVC bags absorbed some drug (page 3, conclusion).
`
`It would have been obvious to one of ordinary skill in the art to substitute a first
`
`pharmaceutical container, a glass container, as taught by Baaske with a second
`
`pharmaceutical container, polyethylene, as taught by Zeidler with a reasonable
`
`expectation of success because the simple substitution of one known element for
`
`another would have yielded predictable results to one of ordinary skill in the art at the
`
`time of the invention. M.P.E.P. §2144.07 states "The selection of a known material
`
`based on its suitability for its intended use supported a prima facie obviousness
`
`determination in Sinclair& Carroll Co. v. lnterchemica/ Corp., 325 U.S. 327, 65 USPQ
`
`297 (1945).” When substituting equivalents known in the prior art for the same purpose,
`
`an express suggestion to substitute one equivalent component or process for another is
`
`not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ
`
`532 (CCPA 1982). M.P.E.P. §2144.06.
`
`One of ordinary skill in the art at the time the invention was made would have a
`
`reasonable expectation of success in using polyethylene container for the nicardipine
`
`Sandoz
`
`Exhibit1016
`
`Page11
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`Sandoz Exhibit 1016 Page 11
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`

`

`Application/Control Number: 12/971 ,084
`Art Unit: 1613
`
`Page 11
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`composition taught by Baaske because Zeidler teaches both glass and PE containers
`
`have basically the same properties for drug solution storage (page 3, conclusion).
`
`It would have been prima facie obvious to one of ordinary skill in the art at the
`
`time the invention was made to use the nicardipine solutions taught by Baaske
`
`(abstract) to treat acute hypertension and induce hypotension as Hersey teaches the
`
`use of nicardipine to induce controlled hypotension is known and well established
`
`technique (abstract, page 1239, first column, first paragraph) and Varon teaches
`
`nicardipine is FDA approved to treat severe hypertension (abstract, page 6, fourth
`
`paragraph).
`
`It would have been obvious to the skilled artisan to use the nicardipine
`
`compositions taught to treat hypertension by Baaske (abstract, 1701, first column, first
`
`paragraph) for uses which are taught as well known and FDA approved as taught by
`
`Hersey and Varon.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`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
`
`Sandoz
`
`Exhibit1016
`
`Page12
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`Sandoz Exhibit 1016 Page 12
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
`
`Page 12
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`USPQZd 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`
`1985); In re Van Ornum, 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).
`
`Claims 40-51 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 7,659,291.
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`Although the conflicting claims are not identical, they are not patentably distinct from
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`each other because the instant application and the ‘291 patent are directed to a method
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`of use a pharmaceutical composition comprising nicardipine, a tonicity agent, a
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`cosolvent sorbitol, citric acid in overlapping concentrations wherein the composition is
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`pre-mixed and stored in a containers which does not comprise polar polymers to induce
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`hypotension and treat acute elevations in blood pressure.
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`No claims are allowed.
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`Conclusion
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`Sandoz
`
`Exhibit1016
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`Page13
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`Sandoz Exhibit 1016 Page 13
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`

`

`Application/Control Number: 12/971,084
`Art Unit: 1613
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`Page 13
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`Examiner Contact Information
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to LYNDSEY BECKHARDT whose telephone number is
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`(571)270-7676. The examiner can normally be reached on Monday thru Thursday 7:00
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`am to 4:00 pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Brian Kwon can be reached on (571) 272-0581. 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
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`/LYNDSEY BECKHARDT/
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`Examiner, Art Unit 1613
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`/SCOTT LONG/
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`Primary Examiner, Art Unit 1633
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`Sandoz
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`Exhibit1016
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`Page14
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`Sandoz Exhibit 1016 Page 14
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`