UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
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`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`10/616,709
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`07/10/2003
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`Neil P. Desai
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`APP01_005_US
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`2620
`
`01/28/2011
`7590
`66140
`BLANCHARD & ASSOCIATES
`566 WEST ADAMS STREET
`SUIIB 600
`CHICAGO, IL 60661
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`EXAMINER
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`TELLER, ROY R
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`ART UNIT
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`PAPER NUMBER
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`1654
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`MAILDATE
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`DELIVERY MODE
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`01/28/2011
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL-90A (Rev. 04/07)
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`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254
`
`

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`Office Action Summary
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`Application No.
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`10/616,709
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`Examiner
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`Applicant(s)
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`DESAI ET AL.
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`Art Unit
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`1654
`ROY TELLER
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. 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).
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`Status
`1 )IZ! Responsive to communication(s) filed on 16 December 2010.
`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 G.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)[8J Claim(s) 1-64 and 68-88 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1-64 and 68-88 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`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.
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`Priority under 35 U.S.C. § 119
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`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.
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`Attachment{s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 12110.
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`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20110126
`
`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254
`
`

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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page 2
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`DETAILED ACTION
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`A request for continued examination under 37 CPR 1.114, including the fee set
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`forth in 37 CPR 1.17 ( e ), was filed in this application after final rejection. Since this
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`application is eligible for continued examination under 37 CPR 1.114, and the fee set
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`forth in 37 CPR l. l 7(e) has been timely paid, the finality of the previous Office action
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`has been withdrawn pursuant to 37 CPR 1.114. Applicant's submission filed on 12/16/10
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`has been entered.
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`Claims 1-64 and 68-88 are under examination.
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`Response to Amendments/ Arguments
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`Applicant's arguments and amendments filed 12/16/10 are acknowledged and have been
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`fully considered. Any rejection and/or objection not specifically addressed is herein withdrawn.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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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.
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`Claims 1-64 and 68-88 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Zhang et al. (USPN 6,399,087) in view of Lundgren et al. (USPN 6,576,245) and Sautou-
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`Miranda et al. (International Journal of Pharmaceutics, 1996, 130, pp-251-255).
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`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254
`
`

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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page 3
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`The instant invention is drawn to a sterile pharmaceutical composition for parenteral
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`administration of propofol, wherein said composition is stored in a container having a closure
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`wherein said closure is inert to propofol, wherein the composition comprises:
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`a) about 0.5% to 10% by weight propofol,
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`b) 3-6% by weight of soybean oil,
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`c) 0.2-1.0% by weight of egg lecithin,
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`d) about 2.25% by weight of glycerin,
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`e) sodium hydroxide,
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`f) water to 100%,
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`g) pH between 5.0-8.5,
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`and when the composition in the container sealed with the closure is agitated at a
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`frequency of 300-400 cycles/minute for 16 hours at room temperature, the composition
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`maintains a propofol concentration measured by HPLC that is at least 93% of the starting
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`concentration of the propofol.
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`Zhang et al. discloses a sterile pharmaceutical composition for parenteral administration
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`of propofol, wherein the composition comprises :
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`a) about 1%to2% by weight propofol,
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`b) 3-6% by weight of soybean oil,
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`c) 0.2-1.0% by weight of egg lecithin,
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`d) about 2.25% by weight of glycerin,
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`e) sodium hydroxide,
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`f) water to 100%, and
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`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254
`
`

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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`g) pH between 5.0-7.5.
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`Page 4
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`See, i.e., for example, abstract, column 3, lines 21-22, claims 1-14.
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`Zhang does not disclose a container having a closure wherein said closure is inert to
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`propofol.
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`Lundgren et al. discloses a primary package containing low molecular weight peptide-
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`based thrombin inhibitors which package is sealed with a rubber stopper or plunger containing
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`bromobutyl rubber. Lundgren discloses the preferred low molecular weight peptide based
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`thrombin inhibitor be kept in glass vials or syringes. See, i.e., for example, abstract, column 2,
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`lines 1-2, claims 1-5.
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`Sautou-Miranda et al. discloses propofol stored in glass and polypropylene containers for
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`30 days with little lose of potency. See, for example, abstract, and page 255.
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`It 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 have combined the composition of Zhang with the beneficial teachings of
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`Lundgren because Lundgren discloses the a low molecular weight package sealed with
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`bromobutyl rubber. The brombutyl rubber would inherently work for a low molecular weight
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`(below 1,000 M.W.) composition such as propofol (M.W. -178.27). Further, Sautou-Miranda
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`disclosure of propofol stored in glass and polypropylene containers for 30 days with little lose of
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`potency beneficially teaches a composition of propofol comprising a container which is inert to
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`propofol. It would be obvious to put any known pharmaceutical composition within that type of
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`sealed container-for well known sterility, stability and transport purposes. Sautou-Miranda
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`disclosure of propofol stored in glass and polypropylene containers for 30 days with little lose of
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`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254
`
`

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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page 5
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`potency mimics the outcome of the instant claims composition that maintains a propofol
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`concentration that is at least 93% of the starting concentration of propofol.
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`Applicant's arguments as they pertain to the art rejection above have been carefully
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`considered but were not found persuasive. Applicant contends that the Zhang reference does not
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`disclose any container at all for storing propofol. Applicant further contends that the cited
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`reference fails to disclose claim limitations relating to the container. However, the examiner
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`contends that the Lundgren reference discloses a primary package containing low molecular
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`weight peptide-based thrombin inhibitors which package is sealed with a rubber stopper or
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`plunger containing bromobutyl rubber. Lundgren discloses the preferred low molecular weight
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`peptide based thrombin inhibitor be kept in glass vials or syringes. The brombutyl rubber would
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`inherently work for a low molecular weight (below 1,000 M.W.) composition such as propofol
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`(M.W. -178.27). Further, Sautou-Miranda disclosure of propofol stored in glass and
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`polypropylene containers for 30 days with little lose of potency beneficially teaches a
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`composition of propofol comprising a container which is inert to propofol.
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`Conclusion
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`All claims are rejected.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Roy Teller whose telephone number is 571-272-0971. The
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`examiner can normally be reached on Monday-Friday from 5:30 am to 2:00 pm ..
`
`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254
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`

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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page 6
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Cecilia Tsang, can be reached on 571-272-0562. The fax phone number for the
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`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
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
`
`/Roy Teller/
`Examiner-1654
`1/26/11
`
`Fresenius Ex. 2029
`Bass et al. v. Fresenius Kabi USA, IPR2016-00254