`
`
`EXHIBIT 1006(A)
`EXHIBIT 1006(A)
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/879,515
`
`09/10/2010
`
`AmarLulla
`
`7590
`30652
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`11/23/2011
`
`CRT/20632C
`US(4137-04703)
`
`7133
`
`EXAMINER
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`MAIL DATE
`
`DELIVERY MODE
`
`11/23/2011
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Examiner-Initiated Interview Summary
`
`Application No.
`
`12/879,515
`
`Examiner
`
`THOR NIELSEN
`
`Applicant(s)
`
`LULLA ET AL.
`
`Art Unit
`
`1616
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) THOR NIELSEN.
`
`(2) Mr. Rodney Carroll.
`
`(3) __ .
`
`(4) __ .
`
`Type:
`
`Date of Interview: 19 November 2011.
`IZI Telephonic D Video Conference
`D Personal [copy given to: D applicant
`Exhibit shown or demonstration conducted: D Yes
`If Yes, brief description: __ .
`
`D applicant's representative]
`IZI No.
`
`Issues Discussed D101 D112 D102 0103 IZ!Others
`(For each of the checked box(es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: 1-34.
`
`Identification of prior art discussed: __ .
`
`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
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc ... )
`
`The examiner suggested amending the claims to accord with prior art identified during prosecution of the parent case
`10/518.016. Specifically, claim 1 would be amended 1) to recite intranasal administration. 2) to delete ''solvate or
`physiologically functional derivative" from element (a). and 3) to limit element (b) to an ester of fluticasone. Claim 2
`would be canceled. Redundant claims would be canceled. The dependency of claims would be amended. Also.
`claims not within the scope of claim 1 as amended would be canceled. Mr. Carroll said that he would consult his
`corresponding attorney who in turn would consult the inventors and/or assignee. He expected to respond to the
`suggested Examiner's Amendment by about 11/28/2011.
`
`Applicant recordation instructions: It is not necessary for applicant to provide a separate record of the substance of 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.
`D Attachment
`11/20/11
`
`/Johann R. Richter/
`Supervisory Patent Examiner, Art Unit 1616
`
`U.S. Patent and Trademark Office
`PTOL-413B (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20111118
`
`

`

`
`
`
`EXHIBIT 1006(B)
`EXHIBIT 1006(B)
`
`

`

`Atty. Docket CRT!LTP/20632C US (4137-04703)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants: Amar Lulla, et al.
`
`Serial No.:
`
`12/879,515
`
`Filed:
`
`For:
`
`September 10, 2010
`
`COMBINATION OF AzELASTINE AND
`STEROIDS
`
`§
`§
`§
`§
`§
`§
`§
`§
`§
`
`Group Art Unit:
`
`1616
`
`Examiner:
`
`Thor B. Nielsen
`
`Confirmation No.: 7133
`
`Mail Stop: Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`CERTIFICATE OF SUBMISSION
`
`I hereby certify that this correspondence is being electronically submitted to
`the U.S. Patent and Trademark Office website, www.uspto.gov, on
`/-i--l 12-J l/
`(Date f Subission)
`i ~n
`2 I. /11
`/ ! cL;~ 2> /Lfaf<-
`
`Edith Shek
`
`PRELIMINARY AMENDMENT
`
`Sir:
`
`Prior to examination, Applicants respectfully request the following amendments
`
`to the above-identified patent application. The changes made are shown by underlining
`
`the added text and striking through the deleted text.
`
`Amendments to the Claims are reflected in the listing of claims, which begins
`on page 2 this paper.
`
`Remarks are on page 8 of this paper.
`
`147392-v2/4137-04703
`
`1
`
`

`

`Atty. Docket CRTJLTPJ20632C US (4137-04703)
`
`AMENDMENTS TO THE CLAIMS
`
`Listing of Claims:
`
`1.
`
`(Currently Amended) A method for the prophylaxis or treatment in a mammal of
`
`a condition for which administration of one or more anti-histamines and/or one or more
`
`steroids is indicated, comprising intranasal administration to said mammal of a
`
`therapeutically effective amount of a pharmaceutical composition comprising (a)
`
`azelastine, or a pharmaceutically acceptable salt, solvate or physiologically functional
`
`derivative thereof; and (b) fluticasone or a pharmaceutically acceptable ester of
`
`flu ticasonethereof.
`
`2.
`
`(Cancelled)
`
`3.
`
`(Currently Amended) The method of claim 1 or claim 2, wherein said
`
`pharmaceutically acceptable salt of azelastine is azelastine HCI.
`
`4.
`
`(Currently Amended) The method of claim 1 or claim 2, wherein said
`
`pharmaceutically acceptable ester of fluticasone is fluticasone propionate or fluticasone
`
`valerate.
`
`5.
`
`(Cancelled)
`
`147392-vZ/4137-04703
`
`2
`
`

`

`Atty. Docket CRTJLTP/20632C US (4137-04703)
`
`6.
`
`(Currently Amended) The method of claim 51, wherein said pharmaceutical
`
`composition is in the form of a nasal spray.
`
`7.
`
`(Currently Amended) The method of claim 51, wherein said pharmaceutical
`
`composition is in the form of nasal drops.
`
`8.
`
`(Currently Amended) The method of claim 51, wherein said pharmaceutical
`
`composition is the form of an insufflation powder.
`
`9-18.
`
`(Cancelled)
`
`19.
`
`(Currently Amended) The method of claim 1 or claim 2, wherein said mammal is
`
`a human.
`
`20.
`
`(Currently Amended) The method of claim 1 or claim 2, wherein said condition
`
`is allergic rhinitis.
`
`21.
`
`(Currently Amended) The method of claim 1 or claim 2, wherein said condition
`
`is allergic conjunctivitis.
`
`22.
`
`(Currently Amended) The method of any one of claims 1, 5, 9, and 10, wherein
`
`said pharmaceutical composition comprises fluticasone or a pharmaceutically acceptable
`
`147392-v2/4137-04703
`
`3
`
`

`

`Atty. Docket CRT/LTP/20632C US (4137-04703)
`
`ester of fluticasonethereof in an amount from about 50 micrograms/ml to about 5 mg/ml
`
`of the composition.
`
`23.
`
`(Original)
`
`The method of claim 22, wherein the pharmaceutical composition
`
`has a particle size of less than 10 µm.
`
`24.
`
`(Currently Amended) The method of claim §.1, wherein said pharmaceutical
`
`composition is an aqueous suspension comprising from about 0.0005% to about 2%
`
`(weight/weight) of azelastine or a pharmaceutically acceptable salt of azelastine, and
`
`from about M0.0357%
`
`to about 1.5%
`
`(weight/weight) of fluticasone or a
`
`pharmaceutically acceptable ester of fluticasonethereof.
`
`25.
`
`(Currently Amended) The method of claim 24, wherein said pharmaceutical
`
`composition is an aqueous suspension comprising from about 0.001 % to about 1 %
`
`(weight/weight) of azelastine or a pharmaceutically acceptable salt of azelastine, and
`
`from about M0.0357%
`
`to
`
`about 1.5%
`
`(weight/weight) of fluticasone or a
`
`pharmaceutically acceptable ester of fluticasonethereof.
`
`26.
`
`(Currently Amended) The method of claim 24, wherein said pharmaceutical
`
`composition is an aqueous suspension comprising 0.1 % or 0.15% (weight/weight) of
`
`azelastine HCl and from about M0.0357% to about 1.5% (weight to weight) of
`
`fluticasone propionate or fluticasone valerate.
`
`147392-v2/4137-04703
`
`4
`
`

`

`Atty. Docket CRT/LTP/20632C US (4137-04703)
`
`27.
`
`(Currently Amended) The method of claim §.1, wherein said pharmaceutical
`
`composition further comprises at least one surfactant selected from the group consisting
`
`of a polysorbate surfactant.,_ ftflEl-a poloxamer surfactant, and combinations thereof.
`
`28.
`
`(Original)
`
`The method of claim 27, wherein said pharmaceutical composition
`
`comprises from about 50 micrograms to about 1 milligram of said surfactant per ml of the
`
`formulation.
`
`29.
`
`(Currently Amended) The method of claim §.1, wherein said pharmaceutical
`
`composition further comprises at least one isotonicity agent selected from the group
`
`consisting of sodium chloride, saccharose, glucose, glycerine, sorbitol.,_ and-1,2-
`
`propylene glycol, and combinations thereof.
`
`30.
`
`(Currently Amended) The method of claim §.1, wherein said pharmaceutical
`
`composition further comprises at least one additional component selected from the group
`
`consisting of a buffer, a preservative.,_ ftflEl-a suspending agent., Bf a thickening agent, and
`
`combinations thereof.
`
`31.
`
`(Original)
`
`The method of claim 30, wherein said buffer is a citric acid-citrate
`
`buffer.
`
`147392-v2/4137-04703
`
`5
`
`

`

`Atty. Docket CRTJLTPJ20632C US (4137-04703)
`
`32.
`
`(Currently Amended) The method of claim 30, wherein said preservative is
`
`selected from the group consisting of edetic acid and its alkali salts, lower alkyl p(cid:173)
`
`hydroxybenzoates, chlorhexidine, phenyl mercury borate, benzoic acid or a salt thereof, a
`
`quaternary ammonium compound, i:tlli:1--sorbic acid or a salt thereof, and combinations
`
`thereof.
`
`33.
`
`(Currently Amended) The method of claim 30, wherein said suspending agent or
`
`thickening agent is selected from the group consisting of cellulose derivatives, gelatin,
`
`polyvinylpyrrolidone, tragacanth, ethoxose, alginic acid, polyvinyl alcohol, polyacrylic
`
`acid_,_ ftfl:d-pectin. and combinations thereof.
`
`34.
`
`(Currently Amended) The method of claim Wl, wherein said buffer maintains the
`
`pH of the aqueous phase of said formulation atcomprises a pH of from 3 to 7.
`
`35.
`
`(New) The method of claim 1, wherein said formulation comprises a pH from 4.5
`
`to 6.5.
`
`36.
`
`(New) The method of claim 27, wherein said surfactant comprises a polysorbate.
`
`37.
`
`(New) The method of claim 29, wherein said isotonic agent comprises glycerine.
`
`147392-v2/4137-04703
`
`6
`
`

`

`Atty. Docket CRT/LTP/20632C US (4137-04703)
`
`38.
`
`(New) The method of claim 30, wherein said preservative comprises edetate
`
`disodium and benzalkonium chloride.
`
`39.
`
`(New) The method of claim 30, wherein said suspending agent or said thickening
`
`agent comprises cellulose derivatives.
`
`40.
`
`(New) The method of claim 1, wherein the pharmaceutical composition further
`
`comprises edetate disodium, glycerine, a thickening agent comprising microcrystalline
`
`cellulose and sodium carboxy methyl cellulose, polysorbate 80, benzalkonium chloride,
`
`phenyl ethyl alcohol, and purified water.
`
`147392-v2/4137-04703
`
`7
`
`

`

`Atty. Docket CRT/LTP/20632C US (4137-04703)
`
`Status of Claims
`
`REMARKS
`
`Claims 1, 3-4, 6-8, 19-22, 24-27, 29-30, and 32-34 have been amended.
`
`Claims 2, 5, and 9-18 have been cancelled.
`
`Claims 35-40 are new.
`
`Claims 1, 3-4, 6-8, and 19-40 are currently pending in this application.
`
`Applicants hereby request examination of the presently claimed application.
`
`Examiner-Initiated Interview
`
`Applicants thank the Examiner for
`
`initiating the
`
`telephonic interview of
`
`November 19, 2011, the content of which is accurately reflected in the Interview
`
`Summary mailed November 23, 2011 and in the amendments set forth in this submission.
`
`Amendments
`
`Independent claim 1 has been amended as described in the Interview Summary.
`
`Dependent claims 3-4, 6-8, 19-22, 24-27, 29, and 30 have been amended to
`
`provide proper dependency and antecedent basis in view of the amendments to
`
`independent claim 1.
`
`Dependent claims 24-26 have been further amended to recite a lower endpoint of
`
`"0.0357%"of a pharmaceutically acceptable ester of fluticasone, which is consistent with
`
`claims 7, 8, 57, 58, 78, and 79 of the allowed parent application 10/518,016.
`
`147392-v2/4137-04703
`
`8
`
`

`

`Atty. Docket CRTJLTPJ20632C US (4137-04703)
`
`Dependent claims 27, 29, 30, 32, and 33 have been amended to recite "and
`
`combinations thereof," which is consistent with claims 10, 13, 14, 15, and 16,
`
`respectively, of the allowed parent application 10/518,016.
`
`Dependent claim 34 has been amended and new claim 35 has been added reciting
`
`pH ranges corresponding to claims 76 and 77, respectively, of the allowed parent
`
`application 10/518,016.
`
`New claims 36-40 correspond to claims 69-73, respectively, of the allowed parent
`
`application 10/518,016.
`
`Applicants respectfully submit that no new matter has been added by way of these
`
`amendments.
`
`147392-v2/4137-04703
`
`9
`
`

`

`Atty. Docket CRTJLTP/20632C US (4137-04703)
`
`CONCLUSION
`
`Applicants respectfully submit that the present application as amended is in
`
`condition for examination. If the Examiner has any questions or comments or otherwise
`
`feels it would be helpful in expediting this correction, he is encouraged to telephone the
`
`undersigned at (972) 731-2288.
`
`The Commissioner is hereby authorized to charge payment of any fee associated
`
`with any of the foregoing papers submitted herewith to Deposit Account No. 50-1515,
`
`Conley Rose, P.C.
`
`Respectfully submitted,
`
`CONLEY ROSE, P.C.
`
`Date: _{l _.,,. /_2 '__,___{ {_
`
`5601 Granite Parkway, Suite 750
`Plano, Texas 75024
`Telephone: (972) 731-2288
`
`,
`
`-:,/,
`Re 1{ o. 39,624
`
`ATTORNEY FOR APPLICANTS
`
`147392-vZ/4137-04703
`
`10
`
`

`

`
`
`
`EXHIBIT 1006(C)
`EXHIBIT 1006(C)
`
`

`

`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
`
`30652
`7590
`CONLEY ROSE, P.C.
`5601 GRANIIB PARKWAY, SUIIB 750
`PLANO, TX 75024
`
`01/26/2012
`
`EXAMINER
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`DATE MAILED: 01/26/2012
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/879,515
`
`09/10/2010
`
`AmarLulla
`
`TITLE OF INVENTION: COMBINATION OF AZELASTINE AND STEROIDS
`
`CRT/20632C
`US(4137-04703)
`
`7133
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`NO
`
`$1740
`
`$300
`
`$0
`
`$2040
`
`04/26/2012
`
`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 SMALL ENTITY status shown above.
`
`If the SMALL ENTITY is shown as YES, verify your current
`SMALL ENTITY status:
`
`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
`above.
`B. If the status above is to be removed, check box 5b on Part B -
`Fee(s) Transmittal and pay the PUBLICATION FEE (if required)
`and twice the amount of the ISSUE FEE shown above, or
`
`If the SMALL ENTITY is shown as NO:
`
`A. Pay TOTAL FEE(S) DUE shown above, or
`
`B. If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check box 5a on Part B - Fee(s)
`Transmittal and pay the PUBLICATION FEE (if required) and 1/2
`the ISSUE FEE shown above.
`
`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 1 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
`(571)-273-2885
`
`or Fax
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks I 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 I, 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 I for any change of address)
`
`30652
`7590
`CONLEY ROSE, P.C.
`5601 GRANIIB PARKWAY, SUIIB 750
`PLANO, TX 75024
`
`01/26/2012
`
`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.
`
`12/879,515
`
`09/10/2010
`
`AmarLulla
`
`TITLE OF INVENTION: COMBINATION OF AZELASTINE AND STEROIDS
`
`CRT/20632C
`US(4137-04703)
`
`7133
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`NO
`
`$1740
`
`$300
`
`$0
`
`$2040
`
`04/26/2012
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`NIELSEN, THOR B
`
`1616
`
`514-171000
`
`I. 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
`(I) 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.
`
`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
`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 O Corporation or other private group entity O Government
`
`4a. The following fee(s) are submitted:
`0 Issue Fee
`0 Publication Fee (No small entity discount permitted)
`0 Advance Order - # of Copies _________ _
`
`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 PTO-2038 is attached.
`0 The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any
`( enclose an extra copy of this form).
`overpayment, to Deposit Account Number
`
`5. Change in Entity Status (from status indicated above)
`0 b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR l.27(g)(2).
`0 a. Applicant claims SMALL ENTITY status. See 37 CFR 1.27.
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown by the records of the United States Patent and Trademark Office.
`
`Authorized Signature _______________________ _
`
`Date ____________________ _
`
`Typed or printed name ______________________ _
`
`Registration No. ________________ _
`
`This collection of information 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 minutes 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 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 0MB control number.
`
`PTOL-85 (Rev. 02/11) Approved for use through 08/31/2013.
`
`0MB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`

`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.
`
`12/879,515
`
`09/10/2010
`
`AmarLulla
`
`30652
`7590
`CONLEY ROSE, P,C,
`5601 GRANIIB PARKWAY, SUIIB 750
`PLANO, TX 75024
`
`01/26/2012
`
`CRT/20632C
`JJSf4J 37-Q47Q3)
`EXAMINER
`
`7133
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`DATE MAILED: 01/26/2012
`
`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 77 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 77 day(s).
`
`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 Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571 )-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`

`

`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 patent application or patent. If you do not furnish the
`requested information, the U.S. Patent 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 Information 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.
`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting
`evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel
`in the course of settlement negotiations.
`3. 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.
`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) and 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 and
`programs, under 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 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 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.
`
`12/879,515
`Examiner
`
`Applicant(s)
`
`LULLA ET AL.
`Art Unit
`
`THOR NIELSEN
`
`1616
`
`-- The MAILING DA TE 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 MPEP 1308.
`1. [8J This communication is responsive to 12/12/2011.
`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 1,3.4.6-8 and 19-40.
`4. [8J Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`b) D Some*
`c) D None
`a) [8J All
`of the:
`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. [8J 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. □ A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`6. D CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PTO-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) D 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).
`
`7. □ 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. D Notice of References Cited (PTO-892)
`2. D Notice of Draftperson's Patent Drawing Review (PTO-948)
`
`3. [8J Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date See Continuation Sheet
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PTO-413),
`Paper No./Mail Date __ .
`7. D Examiner's Amendment/Comment
`
`8. [8J Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 03-11)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20120116
`
`

`

`Continuation Sheet (PTOL-37)
`
`Application No. 12/879,515
`
`Continuation of Attachment(s) 3. Information Disclosure Statements (PTO/SB/08), Paper No./Mail Date: 09/29/201 O; 11 /03/201 O;
`03/22/2011; 08/19/2011 a; 08/19/2011 b; 12/12/2011 a; 12/12/2011 b; 12/12/2011 c .
`
`2
`
`

`

`Application/Control Number: