Exhibit 1022
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1022
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01799
`
`

`
`
`
`UNITED STATES PATENT 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 usplo gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`EXAMINER
`
`LANDSMAN, ROBERT S
`
`1647
`
`DATE MAILED: 05/06/2014
`
`APPLICATION NO.
`FILING DATE
`FIRST NAI\/IED INVENTOR
`A'I"I'()RNEY D()CKE'I' N0.
`C()NFIRMA'I'I()N N0.
`
`13/895,124
`05/15/2013
`S. George Kottayil
`INS 10763P0009 IUS
`3808
`TITLE OF INVENTION: SUBLINGUAL FENTANYL SPRAY AND METHODS OF TREATING PAIN
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`IS SUE FEE DUE
`
`PUBLICATION EEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`$480
`
`$0
`
`$0
`
`$480
`
`08/06/2014
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF TIIIS NOTICE OR TIIIS APPLICATION SIIALL BE REGARDED AS ABANDONED.
`TIIIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`VVILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is sl1ow11 as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`
`If the ENTITY STATUS is changed from that shown above, on PART B — FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`
`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entity
`fees.
`
`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL—85 (Rev. 02/11)
`
`Page I of 3
`
`

`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or @ (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`p(propriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`n icated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`a i
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1f0r any Chingt of address)
`
`7590
`32115
`WOOD, PHILLIPS.
`500 W» MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`05/06/2014
`
`& MORTIMER
`
`Note: A certificate of _mailii_i _ can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any ot ier accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`ave its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`?r‘1‘1§‘ii?3‘§d‘?o LtlIl1EE::I1}"ISal;1"I‘(S)t(()§)71§S217"?]:7—218i87§i 3311353a?§’?X(%c£Ed'°§é‘i§wfa°S”“‘1°
`‘
`_
`
`(Sigznature) (Date)
`
`1””)
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION VO.
`
`S. George Kottayil
`05/15/2013
`13/895,124
`TITLE OF INVENTION: SUBLINGUAL FENTANYL SPRAY AND METHODS OF TREATING PAIN
`
`INS 10763P0009 1US
`
`3808
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`IS SUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`LANDSMAN, ROBERT S
`
`$480
`
`1647
`
`$0
`
`$0
`
`$480
`
`08/06/2014
`
`514—329000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`:1 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/122) attached.
`
`:1 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Vumber is required.
`
`
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`1
`
`2
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`rccordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : D Individual D Corporation or other private group entity D Government
`
`4a. The following fee(s) are submitted:
`:1 Issue Fee
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`:1 A check is enclosed.
`
`:1 Publication Fee (No small entity discount permitted)
`:1 Advance Order — # of Copies
`
`:1 Payment by credit card. Form PTO—2038 is attached.
`:1 The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`5. Change in Entity Status (from status indicated above)
`:1 Applicant certifying micro entity status. See 37 CFR 1.29
`
`:1 Applicant asserting small entity status. See 37 CFR 1.27
`
`:1 Applicant changing to regular undiscounted fee status.
`
`VOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`VOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`VOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature reguirements and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`Page 2 of 3
`
`PTOL—85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISS ONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www uspln gov
`
`13/895,124
`
`05/15/2013
`
`s. George Kottayil
`
`INS10763P00091US
`
`3808
`
`32] 16
`
`7590
`
`05/06/2014
`
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`LANDSMAN, ROBERT s
`
`1647
`
`DATE MAILED: 05/06/2014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1—(888)—786—0101 or (571)-272-4200.
`
`PTOL-S5 (Rev. 02/11)
`
`Page 3 of 3
`
`

`
`_
`
`_
`
`_
`
`,
`
`‘ pplication No.
`
`13/895,124
`
`‘ pplicant(s)
`
`S. George Kottayil
`
`Notzce Reqazrzng Inventor s Oath or Declaration
`
`I xaminer
`I ANDSMAN, ROBERT s
`
`rt Unit
`1647
`
`This notice is an attachment to the Notice of Allowability (PTOL—37), or the Notice of Allowability For A Design
`Application (PTOL—37D).
`
`An inventor’s oath or declaration in compliance with 37 CFR 1.63 or 1.64 executed by or with respect to each
`inventor has not yet been submitted.
`
`An oath or declaration in compliance with 37 CFR 1.63, or a substitute statement in compliance with 37 CFR
`1.64, executed by or With respect to each invcntor (for any invcntor for which a compliant oath, declaration, or
`substitute statement has not yet been submitted) MUST be filed no later than the date on which the issue fee is
`1% See 35 U.S.C. 115(f). Failure to timely comply will result in ABANDONMENT of this application.
`
`A properly executed inventor’s oath to declaration has not been received for the following inventor(s):
`
`If applicant previously filed one or more oaths, declarations, or substitute statements, applicant may have received
`an informational notice regarding deficiencies therein.
`
`The following deficiencies are noted:
`INFORMAL ACTION PROBLEMS
`
`A new inventor's oath or declaration that identifies this application (e.g., by Application Number and filing
`date) is required. The inventor's oath or declaration does not comply with 37 CFR 1.63 in that it:
`
`-does not state that the above—identified application was made or authorized to be made by the person
`executing the oath or declaration: S. George Kottayil, Venkat R. Goskonda, Zhongyuan Zhu, Linet
`Kattookaran, and Neha Parikh.
`
`Questions relating to this Notice should be directed to the Application Assistance Unit at 571-272-4200.
`
`U.S. Patent and Trademark Office
`
`PTO_23O6 (01-13)
`
`Notice Requiring Inventor’s Oath or Declaration
`
`

`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
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`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CFR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is
`governed by 35 U.S.C. 122 a11d 37 CFR 1.14. This collection is estimated to take 12 111inutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
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`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection wit11 your
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`requirements of the Act, please be advised that: (1) the general authority for the collection of this information is
`35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which
`the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission
`related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and
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`proceedings or abandonment of the application or expiration of the pate11t.
`
`The information provided by you in this form will be subject to the following routine uses:
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) a11d the Privacy Act (5 U.S.C 552a). Records from this system of records
`may be disclosed to the Department of Justice to determine whether disclosure of these records is required
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`2. A record fro111 this system of records may be disclosed, as a routine use, i11 the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
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`3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
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`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to
`comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) a11d for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's
`responsibility to recommend improvements in records management practices a11d programs, u11der authority
`of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations
`governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive.
`Such disclosure shall not be used to make determinations about individuals.
`
`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication
`of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the
`record was filed in an application which became abandoned or in which the proceedings were terminated
`and which application is referenced by either a published application, an application open to public
`inspection or an issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`

`
`Notice of Allowability
`
`Application No.
`13/895,124
`'F5£:';it"f;ndSman
`
`App|icant(s)
`KOTTAYIL ET AL.
`'1°*gt4;’"“
`’F‘:{:,‘§,;S,L's""°"‘°' ‘°
`No
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IX This communication is responsive to the amendment dated 4/15/14.
`
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. I] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`: the restriction
`
`3. IX! The allowed cIaim(s) is/are E As a result of the allowed cIaim(s), 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
`hit’ :/./www.us' to. ov/ atents/init events/"
`ft/incfex.'s' or send an inquiry to PPHi'eedback us togov .
`
`4. El Acknowledgment is made of a claim forforeign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`Certified copies:
`
`a) I:| All
`
`b) El Some
`
`*c) I:I None of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No.
`
`3. El 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)).
`
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” ofthis communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. I] CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`I:I
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121 (d).
`
`6. El DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. El Notice of References Cited (PTO—892)
`
`2. El Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. I] Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] Interview Summary (PTO-413),
`Paper No./Mail Date
`
`5. IZI Examiner’s Amendment/Comment
`
`6. El Examiner's Statement of Reasons for Allowance
`
`7. |:I Other
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140429
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 2
`
`EXAMINER’S AMENDMENT
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`An examiner’s amendment to the record appears below. Should the changes and/or additions be
`
`unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure
`
`consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
`
`Authorization for this eXaminer’s amendment to the claims was given in a telephone interview
`
`with Mark Polyakov on April 29, 2014.
`
`In the specification:
`
`Amend the title to the following —
`
`SUBLINGUAL FENTANYL SPRAY AND METHODS OF TREATING PAIN
`
`In the claims:
`
`Replace claim 2 with the following —
`
`2.
`
`A method of treating pain comprising sublingually administering an effective amount of the
`
`sublingual formulation according to claim to a human patient experiencing pain.
`
`Replace claim 3 with the following —
`
`3.
`
`A multi—dose device for sublingual administration of a drug comprising:
`
`a reservoir containing the liquid formulation comprising fentanyl, or a fentanyl derivative selected from
`
`the group consisting of sufentanil, carfentanil, lofentanil and alfatenil, a free base or a pharmaceutically
`
`acceptable salt thereof, in a pharmaceutically acceptable liquid carrier; and
`
`the device having an actuator which when actuated delivers a therapeutically effective dose of the liquid
`
`formulation in the form of liquid droplets having a mean diameter of from about 30 to about 70 microns.
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 3
`
`EXAMINER’S COMMENT
`
`Claims 1, 4 and 5 are directed to an allowable product. Pursuant to the procedures set forth in
`
`MPEP § 821.04(B), claims 2 and 3, directed to the process of making or using an allowable product,
`
`previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and
`
`fully examined for patentability under 37 CFR 1.104.
`
`Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been
`
`rejoined, the restriction requirement as set forth in the Office action mailed on 11/21/13 is hereby
`
`Withdrawn. In View of the withdrawal of the restriction requirement as to the rejoined inventions,
`
`applicant(s) are advised that if any claim presented in a continuation or divisional application is
`
`anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such
`
`claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the
`
`claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35
`
`U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32
`
`(CCPA 1971). See also MPEP § 804.01.
`
`Advisory information
`Any inquiry concerning this communication or earlier communications fron1 the examiner should
`be directed to Robert Landsman, Ph.D. whose telephone number is (571) 272-0888. The examiner can
`normally be reached M—F 8 AM — 6 PM (eastern).
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`
`/Robert Landsmanl
`
`Primary Examiner, Art Unit 1647