`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United Slates Patent and Trademark Ofl'lce
`Addiem: COMMISSIONHK FOR PATIENTS
`PTO Box [-350
`Alexandria. Virginia 11384-150
`\VV:\\' ,ilsplo,gu\‘
`
`APPLICATION NO.
`FILING DA'IE
`FIRST NAMED INVENI‘OR
`ATTORNEY DOCKET NO
`CONFIRMATION NO.
`
`13/541524
`07/03/2012
`Priyanka Roychowdhury
`0773500355
`8238
`
`EXAMINER
`BAKERBome. —
`30 ROCKEFELLER PLAZA
`POLANSKY. GREGG
`44th Floor
`NEW YORK. NY 101 12-4498
`
`ART UNIT
`
`1629
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/ l 7/2012
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`DI .NYDOCKETCDBAKERB()TTS.(‘OI\’I
`
`PI‘OL—‘JOA (Rev, 04/07)
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLc — Exhibit 1058 — Page 1
`
`

`

`Application No.
`
`Applicant(s)
`
`Office Action Summary
`for Applications
`Under Accelerated Examination
`
`13/541,524
`
`Examiner
`
`ROYCHOWDHURY ET AL.
`
`Art Unit
`
`1629
`Gregg Polansky
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Since this application has been granted special status under the accelerated examination program,
`NO extensions of time under 37 CFR 1.136(a) will be permitted and a SHORTENED STATUTORY PERIOD FOR
`REPLY IS SET TO EXPIRE:
`ONE MONTH OR THIRTY (30) DAYS, WHICHEVER IS LONGER,
`FROM THE MAILING DATE OF THIS COMMUNICATION - if this is a non-final action or a Quayle action.
`(Examiner: For FINAL actions, please use PTOL-326.)
`The objective of the accelerated examination program is to complete the examination of an application within twelve
`months from the filing date of the application. Any reply must be filed electronically via EFS-Web so that the papers will
`be expeditiously processed and considered. If the reply is not filed electronically via EFS-Web, the final disposition of the
`application may occur later than twelve months from the filing of the application.
`
`Status
`1 )IZ! Responsive to communication(s) filed on 03 Julv 2012.
`2)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 G.D. 11, 453 O.G. 213.
`3)0 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.
`
`Disposition of Claims
`
`4)!ZI Claim(s) His/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)1Z! Claim(s) His/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) IZ! Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) IZ! Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 710312012 (two).
`
`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 Office
`PTOL-326AE (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120809
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 2
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 2
`
`DETAILED ACTION
`
`Status of Claims
`
`1.
`
`Applicants' two Information Disclosure Statements filed on 7/03/2012 are
`
`acknowledged and have been reviewed.
`
`2.
`
`3.
`
`Claims 1-7 are pending and presently under consideration.
`
`In view of the rejection of the instant claims over the prior art as set forth in the
`
`rejection below, a pre-first action interview with Applicants would likely not have resulted
`
`in the application being placed in condition for allowance and therefore, the interview
`
`was not conducted. However, Applicants' representative, Dennis Bissonnette, was
`
`called on 8/02/2012 to inform him of the status of the application and that a first action
`
`on the merits was forthcoming.
`
`Claim Rejections - 35 USC § 103
`
`4.
`
`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:
`
`(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.
`
`5.
`
`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
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 3
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 3
`
`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(c) and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`6.
`
`Claims 1-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Miyawaki et al. (US 2011/0230534A1 ), evidenced by Precedex® Package Insert
`
`(Document EN-2680, Hospira, Inc., 9/2010, downloaded on 8/10/2012 from
`
`"www.precedex.com/wp-content/uploads/2010/11/Precedex_Pl.pdf", pages 1-24),
`
`Sunkel et al. (US 6806291 B1 ), Ibrahim et al. (US 5716988), and Xylocaine® Package
`
`Insert (AstraZeneca LP, 2001 and 2007, downloaded on 8/10/2012 from
`
`"www.pdr3d.com/print.php?c=4818", pages 1-30).
`
`Miyawaki et al. teach a kit for parenterally administered local anesthesia,
`
`including a local anesthetic agent and dexmedetomidine or a salt thereof. The
`
`dexmedetomidine concentration disclosed by Miyawaki et al. is between 1x10-15 M to
`1 x1 o-6 M (i.e., 2x10-10 µg/ml to 0.2 µg/ml), or more preferably, 1x10-10 M to 1 x1 o-6 M
`
`(i.e., 2x10-5 µg/ml to 0.2 µg/ml). See paragraphs [0023] to [0031 ]. The reference
`
`teaches formulating dexmedetomidine hydrochloride with physiological saline (i.e.,
`
`aqueous 0.9% sodium chloride solution) to prepare solutions having concentrations of
`4x1 o-6 M, 4x10-7 M, 4x1 o-s M and 4x10-9 M (i.e., 0.8 µg/ml, 0.08 µg/ml, 0.008 µg/ml and
`
`0.0008 µg/ml, respectively). See paragraph [0056]. It is noted that the concentrations
`
`taught by Miyawaki et al. (e.g., 0.8 µg/ml) is encompassed by the concentration ranges
`
`of instant Claims 1-3. Further, 0.8 µg/ml also reads on instant Claim 4 (a concentration
`
`of about 1 to about 7 µg/ml) because 0.8 µg/ml is about 1 µg/ml (see the definition of
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 4
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 4
`
`"about" at page 7, paragraph [0035] of the instant Specification). The stock
`
`dexmedetomidine hydrochloride solution used by Miyawaki et al. to prepare the above
`
`solutions was Precedex®, which is provided by the manufacturer in a glass vial. See for
`
`evidentiary purposes the Precedex® Package Insert, page 1, bottom of left column.
`
`Although Miyawaki et al. do not teach the use of sealed glass containers (e.g.
`
`sealed glass vials or ampules), the use of such containers for parenteral
`
`pharmaceuticals is common and well known.
`
`For example, the Xylocaine® Package Insert teaches Xylocaine® (lidocaine HCI)
`
`in isotonic solution is provided in glass ampules and single or multiple dose vials, at
`
`various concentrations. Further, the ampules and vials are provided comprising various
`
`volumes of the parenteral solutions (e.g., 2, 5, 10, 20 and 50 ml). See page 1, the
`
`"Description" section, and page 8, the "How Supplied" section. Sunkel et al. disclose
`
`pharmaceutical compositions for parenteral administration contained in ampules and
`
`multiple dose vials made of glass or plastic. See column 4, lines 14-16 and 29-31. In
`
`fact, the compositions of Sunkel et al. may include dexmedetomidine. See column 5,
`
`line 5. Ibrahim et al. provide another example of the use of sealed glass vials for
`
`parenteral aqueous pharmaceutical solutions. See column 3, lines 45-62, which
`
`discloses aqueous solutions of oxaliplatinum contained in 50 ml sealed glass vials.
`
`It would have been obvious to one of ordinary skill in the art to provide the
`
`dexmedetomidine in sealed glass containers in the kit taught by Miyawaki et al. because
`
`to do so was a common and predictable method of providing parenteral pharmaceutical
`
`compositions at the time of the invention. Additionally, further motivation to use sealed
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 5
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 5
`
`glass containers for the dexmedetomidine solutions taught by Miyawaki et al. comes
`
`from the knowledge that the manufacturer of the dexmedetomidine stock solution used
`
`by Miyawaki et al. (Precedex®) provides the pharmaceutical in a sealed glass vial
`
`(supra). Furthermore, only 2 options are available to the artisan practicing the dilution
`
`instructions of the reference: (1) mixing the solution in a sealed container, or (2) mixing
`
`the solution in an unsealed container. The artisan would clearly immediately envisage
`
`the mixing of the formulation in a sealed container in order to maintain the sterility of the
`
`composition for parenteral administration. Similarly, there are a limited number of
`
`options available to the artisan with regard to the material of the container (e.g., glass,
`
`plastic, or PVC). See In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978),
`
`where claims to a specific compound were anticipated because the prior art taught a
`
`generic formula embracing a limited number of compounds closely related to each other
`
`in structure and the properties possessed by the compound class of the prior art was
`
`that disclosed for the claimed compound. The broad generic formula seemed to
`
`describe an infinite number of compounds but claim 1 was limited to a structure with
`
`only one variable substituent R. This substituent was limited to low alkyl radicals. One
`
`of ordinary skill in the art would at once envisage the subject matter within claim 1 of the
`
`reference.
`
`Providing the dexmedetomidine solutions in various volumes (e.g., 20, 50 or 100
`
`ml) would be obvious. The volume of solution provided would depend on the expected
`
`administered amount of the composition and other variables specific to the treatment at
`
`hand.
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 6
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 6
`
`Finally, the dexmedetomidine solutions provided in the "kit" of Miyawaki et al. are,
`
`by definition, "ready to use."
`
`7.
`
`Claims 1-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Venn
`
`et al. (British Journal of Anaesthesia, 2002, Vol. 88(5), pages 669-675) , in view of
`
`Precedex® Package Insert (Document EN-2680, Hospira, Inc., 9/2010, downloaded on
`
`8/10/2012 from "www.precedex.com/wp-content/uploads/2010/11 /Precedex_Pl.pdf",
`
`pages 1-24), and evidenced by Sunkel et al. (US 6806291 B1 ), Ibrahim et al. (US
`
`5716988), or Xylocaine® Package Insert (AstraZeneca LP, 2001 and 2007, downloaded
`
`on 8/10/2012 from "www.pdr3d.com/print.php?c=4818", pages 1-30).
`
`Venn et al. teach a study of the pharmacokinetics of dexmedetomidine in
`
`patients. The intravenous dexmedetomidine solution used in the study was made by
`
`diluting dexmedetomidine (supplied in 2 ml ampules) with normal saline to produce a
`
`concentration of 8 µg/ml. Precedex® is the source of the 2 ml ampules. See Abstract;
`
`page 670, left column 4th full paragraph; and page 674, left column, 5th full sentence.
`
`This concentration of dexmedetomidine is encompassed by the concentration
`
`ranges of instant Claims 1-3. Further, 8 µg/ml also reads on instant Claim 4 (a
`
`concentration of about 1 to about 7 µg/ml) because 8 µg/ml is about 7 µg/ml (see the
`
`definition of "about" at page 7, paragraph [0035] of the instant Specification).
`
`Although Venn et al. do not teach the use of sealed glass containers (e.g. sealed
`
`glass vials or ampules) for the 8 µg/ml dexmedetomidine solution used for intravenous
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 7
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 7
`
`administration to the patients, the use of such containers for parenteral pharmaceuticals
`
`is common and well known.
`
`For example, the Xylocaine® Package Insert teaches Xylocaine® (lidocaine HCI)
`
`in isotonic solution is provided in glass ampules and single or multiple dose vials, at
`
`various concentrations. Further, the ampules and vials are provided comprising various
`
`volumes of the parenteral solutions (e.g., 2, 5, 10, 20 and 50 ml). See page 1, the
`
`"Description" section, and page 8, the "How Supplied" section. Sunkel et al. disclose
`
`pharmaceutical compositions for parenteral administration contained in ampules and
`
`multiple dose vials made of glass or plastic. See column 4, lines 14-16 and 29-31. In
`
`fact, the compositions of Sunkel et al. may include dexmedetomidine. See column 5,
`
`line 5. Ibrahim et al. provide another example of the use of sealed glass vials for
`
`parenteral aqueous pharmaceutical solutions. See column 3, lines 45-62, which
`
`discloses aqueous solutions of oxaliplatinum contained in 50 ml sealed glass vials.
`
`It would have been obvious to one of ordinary skill in the art to provide the
`
`dexmedetomidine in sealed glass containers prior to administration to patients because
`
`to do so was a common and predictable method of providing parenteral pharmaceutical
`
`compositions at the time of the invention. Additionally, further motivation to use sealed
`
`glass containers for the dexmedetomidine solutions taught by Venn et al. comes from
`
`the knowledge that the manufacturer of the dexmedetomidine stock solution used by
`
`Venn et al. (Precedex®) provides the pharmaceutical in a sealed glass vial (supra).
`
`Furthermore, only 2 options are available to the artisan practicing the dilution
`
`instructions of the reference: (1) mixing the solution in a sealed container, or (2) mixing
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 8
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 8
`
`the solution in an unsealed container. The artisan would clearly immediately envisage
`
`the mixing of the formulation in a sealed container in order to maintain the sterility of the
`
`composition for parenteral administration. Similarly, there are a limited number of
`
`options available to the artisan with regard to the material of the container (e.g., glass,
`
`plastic, or PVC). See In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978),
`
`where claims to a specific compound were anticipated because the prior art taught a
`
`generic formula embracing a limited number of compounds closely related to each other
`
`in structure and the properties possessed by the compound class of the prior art was
`
`that disclosed for the claimed compound. The broad generic formula seemed to
`
`describe an infinite number of compounds but claim 1 was limited to a structure with
`
`only one variable substituent R. This substituent was limited to low alkyl radicals. One
`
`of ordinary skill in the art would at once envisage the subject matter within claim 1 of the
`
`reference.
`
`Providing the dexmedetomidine solutions in various volumes (e.g., 20, 50 or 100
`
`ml) would be obvious. The volume of solution provided would depend on the expected
`
`administered amount of the composition and other variables specific to the treatment at
`
`hand.
`
`8.
`
`Claims 1-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Precedex® Package Insert (Document EN-2680, Hospira, Inc., 9/2010, downloaded on
`
`8/10/2012 from "www.precedex.com/wp-content/uploads/2010/11 /Precedex_Pl.pdf",
`
`pages 1-24), and evidenced by Sunkel et al. (US 6806291 B1 ), Ibrahim et al. (US
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 9
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 9
`
`5716988), or Xylocaine® Package Insert (AstraZeneca LP, 2001 and 2007, downloaded
`
`on 8/10/2012 from "www.pdr3d.com/print.php?c=4818", pages 1-30).
`
`The Precedex® Package Insert teaches Precedex® is dexmedetomidine
`
`hydrochloride for injection and is provided in a sealed glass vial. The Insert teaches the
`
`dexmedetomidine must be diluted prior to use with a 0.9% sodium chloride solution to
`
`provide a final concentration of 4 µg/ml, for administration to the patient. See the first
`
`page, left, column.
`
`This administered concentration of dexmedetomidine is encompassed by the
`
`concentration ranges of instant Claims 1-4.
`
`Although Precedex® Package Insert does not teach the use of sealed glass
`
`containers (e.g. sealed glass vials or ampules) for the 4 µg/ml dexmedetomidine
`
`solution used for intravenous administration to the patients, the use of such containers
`
`for parenteral pharmaceuticals is common and well known.
`
`For example, the Xylocaine® Package Insert teaches Xylocaine® (lidocaine HCI)
`
`in isotonic solution is provided in glass ampules and single or multiple dose vials, at
`
`various concentrations. Further, the ampules and vials are provided comprising various
`
`volumes of the parenteral solutions (e.g., 2, 5, 10, 20 and 50 ml). See page 1, the
`
`"Description" section, and page 8, the "How Supplied" section. Sunkel et al. disclose
`
`pharmaceutical compositions for parenteral administration contained in ampules and
`
`multiple dose vials made of glass or plastic. See column 4, lines 14-16 and 29-31. In
`
`fact, the compositions of Sunkel et al. may include dexmedetomidine. See column 5,
`
`line 5. Ibrahim et al. provide another example of the use of sealed glass vials for
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 10
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 1 O
`
`parenteral aqueous pharmaceutical solutions. See column 3, lines 45-62, which
`
`discloses aqueous solutions of oxaliplatinum contained in 50 ml sealed glass vials.
`
`It would have been obvious to one of ordinary skill in the art to provide the
`
`dexmedetomidine in sealed glass containers prior to administration to patients because
`
`to do so was a common and predictable method of providing parenteral pharmaceutical
`
`compositions at the time of the invention. Additionally, further motivation to use sealed
`
`glass containers for the dexmedetomidine solutions taught by Venn et al. comes from
`
`the knowledge that the manufacturer of the dexmedetomidine stock solution used by
`
`Venn et al. (Precedex®) provides the pharmaceutical in a sealed glass vial (supra).
`
`Furthermore, only 2 options are available to the artisan practicing the dilution
`
`instructions of the reference: (1) mixing the solution in a sealed container, or (2) mixing
`
`the solution in an unsealed container. The artisan would clearly immediately envisage
`
`the mixing of the formulation in a sealed container in order to maintain the sterility of the
`
`composition for parenteral administration. Similarly, there are a limited number of
`
`options available to the artisan with regard to the material of the container (e.g., glass,
`
`plastic, or PVC). See In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978),
`
`where claims to a specific compound were anticipated because the prior art taught a
`
`generic formula embracing a limited number of compounds closely related to each other
`
`in structure and the properties possessed by the compound class of the prior art was
`
`that disclosed for the claimed compound. The broad generic formula seemed to
`
`describe an infinite number of compounds but claim 1 was limited to a structure with
`
`only one variable substituent R. This substituent was limited to low alkyl radicals. One
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 11
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 11
`
`of ordinary skill in the art would at once envisage the subject matter within claim 1 of the
`
`reference.
`
`Providing the dexmedetomidine solutions in various volumes (e.g., 20, 50 or 100
`
`ml) would be obvious. The volume of solution provided would depend on the expected
`
`administered amount of the composition and other variables specific to the treatment at
`
`hand.
`
`Double Patenting
`
`9.
`
`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
`
`USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 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).
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 12
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 12
`
`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).
`
`10.
`
`Claims 1-7 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8,242, 158.
`
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`each other because claims only differ in the recited concentrations of dexmedetomidine.
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`The claims of the '158 patent are drawn to dexmedetomidine at a concentration of 4
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`µg/ml. The instant claims recite concentration ranges of dexmedetomidine that
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`encompass 4 µg/ml.
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`Conclusion
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`11.
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`Claims 1-7 are rejected.
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`12.
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`No claims are allowed.
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`13.
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Gregg Polansky whose telephone number is (571 )272-
`
`9070. The examiner can normally be reached on Mon-Thur 9:30 A.M. - 7:00 P.M. EST.
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 13
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 13
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Jeffrey S. Lundgren can be reached on (571) 272-5541. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
`
`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
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`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
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Gregg Polansky/
`Examiner, Art Unit 1629
`
`/JEFFREYS. LUNDGREN/
`Supervisory Patent Examiner, Art Unit 1629
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1058 – Page 14
`
`