`
`UNITED STATES DEPARTMENT OF COIWVIERCE
`United States Patent and Trademark Office
`Address: COMIVIISSIONER FOR PATENTS
`P O Box 1450
`Alexandria, Virginia 22?]?-1451]
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`51957
`
`7590
`
`12/27/2013
`
`ALLERGAN, INC.
`2525 DUPONT DRIVE, T2-7H
`IRVINE. CA 92612-1599
`
`CORDERO GARCIA, MARCELA M
`
`1 676
`
`DATE MAILED: l2/27/2013
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`1761 SCONZB (AP)
`Andrew Aeheampong
`08/14/2013
`13/967,189
`TITLE OF INVENTION: IVIETHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOS PORIN COMPONENTS
`
`4818
`
`APPLN. TYPE
`
`EN'1'I'1'Y STATUS
`
`ISSUE l'EE DUE
`
`PUBLICATION I"EE DUE
`
`PREV. PAID ISSLE
`
`TOTAL I"EE(S) DUE
`
`nonprovisional
`
`UNDISCOUNIED
`
`$1780
`
`$0
`
`$0
`
`$ 1780
`
`DATE DUE
`
`03/27/2014
`
`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 WITHDRAVVAL 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 VVITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATIITQ LRY PERI! ID CA3 SOT 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 TOVVARD THE ISSUE FEE NOVV
`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 wl1etl1er 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 Oflice
`(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 eonununications 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 patentec's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOI.—S5 (Rev. 02/1 1)
`
`Page 1 of 3
`
`1
`
`ALL 2008
`APOTEX V. ALLERGAN
`IPR2015-01286
`
`
`
`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.0. 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
`ap ropriate. All further correspondence including the Patent. advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`in 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.
`
`CURRENT CORRESPONDENCE ADDRESS (Now: US: Block 1101 any 0116113: 01 adtllcbsi
`
`C
`SD57
`
`7590
`
`7
`,1 ,1
`1‘/‘7/“O13
`
`2525 DUPONT DRIVE7 T2'7H
`IRVINE, CA 92612-1599
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`apers. 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 Lnited
`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.
`
`1761 SCONZB (AP)
`Andrew Acheampong
`08/ 14/201 3
`13/967.189
`TITLE OF INVENTION: METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PA ) ISSLE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`UNDISCOUNTED
`nonprovisional
`EXAMINE 1
`
`CORDERO GARCIA, MARCELA M
`
`$ 1780
`ART UNIT
`
`1676
`
`$0
`
`$0
`
`03/27/2014
`
`CLASS-SUB CLASS
`
`5 14- 020500
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR L363)‘
`3 Change of correspondence address (or Change of Correspondence
`Addrcss ("rm PTO/SB/122) attached‘
`3 "Fee Address" indication (or "Fee Address" Indication form
`’TO/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 31101116)’ 01' 339111) 31111 1111‘ 11311155 011113 1_0
`Z_fCg1StCfCd pé11CI1_1 attorneys 01“ agents. If I10 I1aII1C 13
`listed, no name will be printed.
`
`2
`
`3. ASSIGNE3 NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignce is identified below. the document has been filed for
`DLEASE NOTE: Unless an assignce is identified below. no assignee data will appear on the patent.
`recordation 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:
`3 Issue Fee
`3 Publication Fee (No small entity discount permitted)
`3 Advance O1-dcr — # of Copies
`
`5. Change in Entity Status (from status indicated above)
`3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
`3 Applicant changing to regular undiscounted fee status.
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment, lo Deposit Account Number
`(enclose an extra copy of Lhis 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 131 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
`
`l'TOL—85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`US. Patent and Trademark Office; US. DEPARTMENT OF C0.\/IMERCE
`
`2
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTNIENT OF CO3/HVIERCE
`United States Patent and Trademark Office
`Addiess: CO1‘/INIISSIONER FOR PATENTS
`PO. Box 1450
`/Xlexandiiai Virginia 22313-1430
`wWw.uspto.goV
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAIVIED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/967,189
`
`08/ 14/2013
`
`Andrew Acheampong
`
`ALLERGAN, INC_
`2525 DUPONT DRIVE, T2-7H
`IRVINE, CA 92612-1599
`
`17618CON2B (AP)
`EXAIVIINER
`
`48 1 8
`
`CORDERO GARCIA, MARCELA M
`
`1676
`
`DATE MAILED: 12/27/2013
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 0 day(s).
`
`If :1 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://pairuspto. 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 Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`3
`
`
`
`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
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to inform the public about the OMB Control Number’s legal significance i11 accordance with 5 CFR
`l320.5(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 and 37 CFR 1.14. This collection is estimated to take 12 mi11utes 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 lnformation 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
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
`respond to a collection of information unless it displays a valid OMB control number.
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant
`to the
`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 pate11t application or patent. lf you do not furnish the requested information, the U.S. Pate11t and
`Trademark Office may not be able to process and/or examine your submission, which may result in termination of
`proceedings or abandonment of the application or expiration of the patent.
`
`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
`lnfor1natio11 Act (5 U.S.C. 552) and 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
`by the Freedom of Information Act.
`. A record from this system of records may be disclosed, as a routine use, iii the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance
`from the Member with respect to the subject matter of the record.
`. 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).
`. A record related to a11 lnternational Application filed under the Pate11t Cooperation Treaty i11 this system of
`records may be disclosed, as a routine use, to the International Bureau of the World I11tellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`. 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) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`. 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 and 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.
`. 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 CPR 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 a11 issued patent.
`. 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.
`
`4
`
`
`
`Notices of Allowance and Fee(s) Due mailed between October 1, 2013 and
`December 31, 2013
`
`(Addendum to PTOL—85)
`
`If the “Notice of Allowance and Fee(s) Due” has a mailing date on or after October 1, 2013 and before
`January 1, 2014, the following information is applicable to this application.
`
`If the issue fee is being timely paid on or after January 1, 2014, the amount due is the issue fee and
`publication fee in effect January 1, 2014. On January 1, 2014, the issue fees set forth in 37 CFR 1.18
`decrease significantly and the publication fee set forth in 37 CFR l.l8(d)(l) decreases to $0.
`
`If an issue fee or publication fee has been previously paid in this application, applicant is not entitled to a
`refund of the difference between the amount paid and the amount in effect on January 1, 2014.
`
`5
`
`
`
`Applicant-Initiated Interview Summary
`
`Application No.
`
`App|icant(s)
`
`13/967,189
`Examiner
`
`ACHEAMPONG ET AL.
`Art Unit
`
`MARCELA M. CORDERO
`GARCIA
`
`1658
`
`All participants (applicant, applicants representative, PTO personnel):
`
`(1) MARCELA M. CORDERO GARCIA.
`
`(3)
`
`.
`
`(2) LAURA L. WINE.
`
`Date of Interview: 12/2/2013.
`
`Type:
`
`I:| Video Conference
`IZI Telephonic
`I] Personal [copy given to: I] applicant
`
`|:l applicant’s representative]
`
`Exhibit shown or demonstration conducted:
`If Yes, brief description:
`
`I:I Yes
`
`I:l No.
`
`[I101 |:|112 |Z|102 |Z|103 |ZOthers
`Issues Discussed
`(For each of the checked box(es) above. please describe below the issue and detailed description of the discussion)
`
`CIaim(s) discussed: All, in general.
`
`Identification of prior art discussed: US 6 984 628.
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`rcfcrcncc or a portion thcrcof, claim intcrprctation, proposcd amcndmcnts, arguments of any applicd rcfcrcnccs ctc...)
`
`See Continuation Sheet.
`
`Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP
`section 713.04). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or
`thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the
`interview
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`
`El Attachment
`/MARCELA M CORDERO GARC|A/
`Primary Examiner, Art Unit 1676
`
`U.S. Patent and Trademark Office
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20131211
`
`6
`
`
`
`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews
`Paragraph (b)
`
`in every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise. stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so.
`It is the examiner’s responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the
`“Contents” section of the file wrapper.
`In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview.
`In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following Information:
`—Application Number (Series Code and Serial Number)
`— Name of applicant
`—Name of examiner
`— Date of interview
`—Type of interview (telephonic, video-conference, or personal)
`—Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`—An indication whether or not an exhibit was shown or a demonstration conducted
`—An identification of the specific prior art discussed
`— An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`—The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the
`substance of the interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`3) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a brief identification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not
`required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the
`examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully
`describe those arguments which he or she feels were or might be persuasive to the examiner.)
`6) a general indication of any other pertinent matters discussed, and
`7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by
`the examiner.
`Examiners are expected to carefully review the applicants record of the substance of an interview.
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`If the record is not complete and
`
`Examiner to Check tor Accuracy
`
`If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner’s version of the
`statement attributed to him or her.
`If the record is complete and accurate, the examiner should place the indication, “|nterview Record OK” on the
`paper recording the substance of the interview along with the date and the examiner’s initials.
`
`7
`
`
`
`Continuation Sheet (PTOL-413)
`
`Application No. 13/967,189
`
`Continuation of Substance of Interview including description of the general nature of what was agreed to if an
`agreement was reached, or any other comments: Authorization for communication under MPEP 502.03 was filed on
`10/1/2013 by Applicant's representative.Courtesy copy of the OA was given to Applicant's representative via email on
`10/7/2013. The emailed copy was identical to the OA of record, therefore, for the sake of clarity it has not been herein
`included and Applicant's representative. Applicant's representative contacted Examiner on 10/17-18/2013,10/23/2013,
`10/28/2013 and 10/30/2013 and 11/1/2013 to inquire about the application, provide updates regarding the status of the
`application and filings and/or discuss any potential questions and related applications. Examiner provided updates
`regarding the status of the examination as requested. On 10/18/2013, Examiner contacted Applicant's representative
`to discuss the affidavits EXHIBIT 1 and 2 were discussed specifically with regards to the excipients used in phase2 and
`phase3 of the clinical trials described therein, Applicant's representative indicated that the excipients were identical in
`these 2 phases and that this was also set forth in the affidavits, which was confirmed by Examiner (e.g., page 2,
`paragraph 8 of EXHIBIT 1). On 10/23/2013, Applicant's representative along with Maysa Attar contacted Examiner to
`discuss whether any outstanding questions remained from the examination of the courtesy copies of the affidavits.
`Examiner did not have any further questions and indicated that she would act on the case when the official papers
`were filed. Laura Wine contacted Examiner on 10/28/2013 indicating that the response had been filed on 10/23/2013.
`During the final search Examiner found a potential 102(e) reference (US 6 984,623, Table 5). Examiner contacted
`Applicant's representative on 11/4/201 3 to discuss US 6,984,628, which would necesitate a 102(e) rejection (see Table
`5). Applicant's representative filed a 1.131 declaration to obviate such potential rejection (see 1.131 declaration filed
`12/2/2013, for which an identical courtesy copy was also emailed to Examiner. Examiner indicated that the declaration
`was acceptable in a telephonic conversation on 12/9/2013 and requested TDs for 11/897,177, 12/035,698 and
`13/649,287 to obviate potential non-statutory double patenting rejections (see TDs submitted on 12/9/2013).
`Furthermore, Examiner indicated that a TD would be needed with US 6,984,628, however, upon reconsideration, US
`6,984,628 does not require a non-statutory double patenting rejection as indicated in a telephonic message on
`12/17/2013.
`
`8
`
`
`
`Notice of Allowability
`
`Application No.
`13/967,189
`"\5/I’/‘fF':(‘:"|;‘:; Ml CORDERO
`GARCIA
`
`AppIicant(s)
`ACHEAMPONG ET AL.
`f*g;;J""
`’F‘i',",T,‘§'t;,st‘,,'S""""‘°"°
`N0
`
`-- 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 10/7/2013. 10/23/2013. 12/2/2013 and 12/9/2013.
`
`[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 37-48 61-68. As a result of the allowed c|aim(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.i:1ov./ aten ‘/init events/" I1/inciex.'s:) or send an inquiry to PPHfeedba<:k
`us tocov.
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )-(d) or (f).
`Certified copies:
`
`*0) El None of the:
`b) El Some
`a) I] All
`1. El Certified copies of the priority documents have been received.
`2. I:I 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( )).
`* 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. El 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. IX! Notice of References Cited (PTO-892)
`2. El Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. I:I Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. IX] Interview Summary (PTO-413),
`Paper No./Mail Date 20131211 .
`/MARCELA M CORDERO GARCIA/
`
`Primary Examiner, Art Unit 1658
`
`Examiner's Amendment/Comment
`5.
`6. El Examiner‘s Statement of Reasons for Allowance
`
`7. El Other
`
`.
`
`U 8 Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice 01 Allowability
`
`Part of Paper No./Mail Date 20131211
`
`9
`
`
`
`Application/Control Number: 13/967,189
`Art Unit: 1658
`
`DETAILED ACTION
`
`1.
`
`The present application is being examined under the pre—AlA first to invent
`
`provisions.
`
`2.
`
`This Office Action is in response to the reply received on 10/7/2013 and
`
`10/23/2013.
`
`Any rejection from the previous office action, which is not restated here, is
`
`withdrawn.
`
`Status of the claims
`
`3.
`
`Claims 37-48 and 61-68 are pending. Claims 37-48 and 61 -68 are presented for
`
`examination on the merits.
`
`Declarations under 37 CFR 1. 132
`
`4.
`
`The declaration under 37 CFR 1.132 filed 10/23/2013 (EXHIBIT 3 comprising
`
`EXHIBITS A, B and C) has been carefully considered, however it is deemed insufficient
`
`to overcome the rejection of claims 37-61 based upon Ding et al. (US 5,474,979, cited
`
`in the IDS dated 9/12/2013) as set forth in the last Office action because: “Objective
`
`evidence of nonobviousness including commercial success must be commensurate in
`
`scope with the claims. in re Tiffirr, 448 F211 7931, 171 USPO 2244 (CZCPA 1971)
`
`{evidence showing eemmereiai success efthermopiastiz: foam “cups” used in vending
`
`machines was not commensurate in scope with claims direcétect to tharmeplastéc foam
`
`“«::«:3nta1ners” breadiy}, in order to be commensurate * :2 it: «: scope with the ci