`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`14/100,717
`
`ISSUE DATE
`
`11/25/2014
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8895612
`
`30015730-0065
`
`2813
`
`7590
`26263
`DENTONS US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`11/05/2014
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto.gov).
`
`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 Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Luitpold Pharmaceuticals, Inc., Shirley, NY, Assignee (with 37 CFR 1.172 Interest);
`Mary Jane Helenek, Brookville, NY;
`Marc L. Tokars, Douglassville, PA;
`Richard P. Lawrence, Calverton, NY;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage and facilitate business investment. To learn more about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`
`IR103 (Rev. 10/09)
`
`Pharmacosmos, Exh. 1007, p. 1
`
`
`
`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
`(571)-273-2885
`
`or Fax
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated 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.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`26263
`7590
`DENTONS US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`09/22/2014
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have 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
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/100,717
`
`12/09/2013
`
`Mary Jane Helenek
`
`30015730-0065
`
`2813
`
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATEDUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`12/22/2014
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`LAU, JONATHAN S
`
`1673
`
`514-502000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`0 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number 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 DENTONS US LLP
`
`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
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`(A) NAME OF ASSIGNEE
`LUITPOLD PHARMACEUTICALS,
`SHIRLEY, NY
`
`INC.
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : 0 Individual IEl Corporation or other private group entity 0 Government
`
`4a. The following fee(s) are submitted:
`IEl Issue Fee
`IEl Publication Fee (No small entity discount permitted)
`0 Advance Order - #of Copies _________ _
`
`5. Change in Entity Status (from status indicated above)
`0 Applicant certifying micro entity status. See 37 CFR 1.29
`0 Applicant asserting small entity status. See 37 CFR 1.27
`0 Applicant changing to regular undiscounted fee status.
`
`4b. Payment ofFee(s): (Please first reapply any previously paid issue fee shown above)
`0 A check is enclosed.
`lfil Payment by credit card. R~2llil:&~ via EFS.
`lfil The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`(enclose an extra copy of this form).
`overpayment, to Deposit Account Number 19-31.40
`
`NOTE: 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.
`NOTE: 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.
`NOTE: 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 1.31and1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature /Kathleen E. Chaffee I
`
`Date 20 October 2014
`
`Typedorprintedname Kathleen E. Chaffee
`
`Registration No. _6_9_,_9_0_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
`
`Page 2 of3
`
`Pharmacosmos, Exh. 1007, p. 2
`
`
`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`14100717
`
`09-Dec-2013
`
`Title of Invention:
`
`METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`First Named Inventor/Applicant Name:
`
`Mary Jane Helenek
`
`Filer:
`
`Kathleen E. Chaffee/Connie Payne
`
`Attorney Docket Number:
`
`30015730-0065
`
`Filed as Large Entity
`
`Utility under 35 USC 111 (a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Utility Appl Issue Fee
`
`1501
`
`1
`
`960
`
`960
`
`Extension-of-Time:
`
`Pharmacosmos, Exh. 1007, p. 3
`
`
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Miscellaneous:
`
`Total in USO($)
`
`960
`
`Pharmacosmos, Exh. 1007, p. 4
`
`
`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`20456035
`
`14100717
`
`International Application Number:
`
`Confirmation Number:
`
`2813
`
`Title of Invention:
`
`METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`First Named Inventor/Applicant Name:
`
`Mary Jane Helenek
`
`Customer Number:
`
`26263
`
`Filer:
`
`Kathleen E. Chaffee/Connie Payne
`
`Filer Authorized By:
`
`Kathleen E. Chaffee
`
`Attorney Docket Number:
`
`30015730-0065
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`20-0CT-2014
`
`09-DEC-2013
`
`10:31:46
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`yes
`
`Credit Card
`
`$960
`
`8401
`
`193140
`
`CHAFFEE, KATHLEEN
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`Pharmacosmos, Exh. 1007, p. 5
`
`
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`File Size( Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`1
`
`Issue Fee Payment (PT0-85B)
`
`lssue_fee_ Transmittal_3001573
`0-0065.pdf
`
`148470
`
`2fb 15a9b8b4a34e84196480cbd39f9ec50e
`31438
`
`no
`
`1
`
`Warnings:
`
`Information:
`
`2
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`no
`
`2
`
`30179
`
`14 7 a912fca0ec9a dc2fbafad d 5 946a8086a6
`12,
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`178649
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Pharmacosmos, Exh. 1007, p. 6
`
`
`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`26263
`7590
`DENTONS US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`09/22/2014
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1673
`
`DATE MAILED: 09/22/2014
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/100,717
`
`12/09/2013
`
`Mary Jane Helenek
`
`30015730-0065
`
`2813
`
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATEDUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`12/22/2014
`
`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 THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED. THIS
`STATUTORY PERIOD CANNOT BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`IF AN ISSUE FEE HAS
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL 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 shown 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.
`
`IL 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 1of3
`
`Pharmacosmos, Exh. 1007, p. 7
`
`
`
`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
`(571)-273-2885
`
`or Fax
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated 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.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`26263
`7590
`DENTONS US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`09/22/2014
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have 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
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/100,717
`
`12/09/2013
`
`Mary Jane Helenek
`
`30015730-0065
`
`2813
`
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATEDUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`12/22/2014
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`LAU, JONATHAN S
`
`1673
`
`514-502000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`0 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number 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.
`
`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
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`(A) NAME OF ASSIGNEE
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : 0 Individual 0 Corporation or other private group entity 0 Government
`
`4a. The following fee(s) are submitted:
`0 Issue Fee
`0 Publication Fee (No small entity discount permitted)
`0 Advance Order - #of Copies _________ _
`
`5. Change in Entity Status (from status indicated above)
`0 Applicant certifying micro entity status. See 37 CFR 1.29
`0 Applicant asserting small entity status. See 37 CFR 1.27
`0 Applicant changing to regular undiscounted fee status.
`
`4b. Payment ofFee(s): (Please first reapply any previously paid issue fee shown above)
`0 A check is enclosed.
`0 Payment by credit card. Form PT0-2038 is attached.
`0 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).
`
`NOTE: 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.
`NOTE: 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.
`NOTE: 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 1.31and1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature _______________________ _
`
`Date ____________________ _
`
`Typed or printed name ______________________ _
`
`Registration No. ________________ _
`
`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
`
`Page 2 of3
`
`Pharmacosmos, Exh. 1007, p. 8
`
`
`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/100,717
`
`12/09/2013
`
`Mary Jane Helenek
`
`30015730-0065
`
`2813
`
`26263
`7590
`DENTONS US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`09/22/2014
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1673
`
`DATE MAILED: 09/22/2014
`
`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.
`
`Section l(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the
`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 CPR 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
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`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`Pharmacosmos, Exh. 1007, p. 9
`
`
`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`Pharmacosmos, Exh. 1007, p. 10
`
`
`
`Notice of Allowability
`
`Application No.
`14/100,717
`Examiner
`Jonathan S. Lau
`
`Applicant(s)
`HELENEK ET AL.
`AIA (First Inventor to
`Art Unit
`File) Status
`1673
`No
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`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 M PEP 1308.
`
`1. [8J This communication is responsive to 9 Jun 2014.
`DA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`2. D 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.
`
`3. [8J The allowed claim(s) is/are 1.3-10 and 12-22. As a result of the allowed claim(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 ~1tl;Q:i/v1r.rvw.us2to.gov/gatentsiinit events/Qgh/index.js.Q or send an inquiry to PPHfeedback@uS(Qto.aov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) D All
`b) D Some
`1. D Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D 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" of this 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. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`D including changes required by the attached Examiner's Amendment I 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. 0 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. [8J Notice of References Cited (PT0-892)
`2. [8J Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date §..Qg.§.
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`
`/LAYLA BLAND/
`Primary Examiner, Art Unit 1673
`
`5. [8J Examiner's Amendment/Comment
`6. [8J Examiner's Statement of Reasons for Allowance
`7. D Other __ .
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140916
`
`Pharmacosmos, Exh. 1007, p. 11
`
`
`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 2
`
`EXAMINER'S AMENDMENT
`
`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 was given in a telephone interview
`
`with Kathleen Chaffee on 16 Sep 2014.
`
`The application has been amended as follows:
`
`Amendment to the Claims
`
`• Claim 1 is amended as follows:
`
`1. (currently amended) A method of treating a disease, disorder, or condition
`
`characterized by iron deficiency or dysfunctional iron metabolism resulting in reduced
`
`bioavailability of dietary iron, comprising
`
`administering to a subject in need thereof an iron carbohydrate complex in a
`
`single dosage unit of at least about 0.6 grams of elemental iron;
`
`wherein
`
`the iron carbohydrate complex is selected from the group consisting of an
`
`iron carboxymaltose complex, an iron mannitol complex, an iron polyisomaltose
`
`complex, an iron polymaltose complex, an iron sorbitol complex, and an iron
`
`polyglucose sorbitol carboxymethy