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`
`UNITED STATES DEPARTMENT OF COIVDIER("E
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`NOTICE OF ALLOWANCE AND FEE(S) DUE
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`PHILIP S. JOHNSON
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`ONE JOHNSON & JOHNSON PLAZA
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`
`APPLlL"A'l'lOl\' NO.
`
`I-"ILIl\'(i Dz—\TIZ
`
`FIRST NAMED I,\IVIiNTt')R
`
`
`
`Alzm ll. Auerbach
`O2/Z4/2011
`I3/034,340
`TITLE OF INVENTION: METHODS AND C‘OMPOSl'l'IONS FOR TRI9.’/\'l'lN(‘r (‘ANCIYR
`
`EXAMINER
`
`nU1.s+w MING R
`
`
`
`mt
`DATE MAILED: 02/l l/Z014
`
`
`
`ATTORNI-LY DOC NO,
`("()NFIRIVIA'I l0l\' NO.
`
`
`CURSOOI l.'S(‘,\'Tl
`I597
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`APPLN. TYPE
`ENTITY STATUS
`ISSUE
`DUE
`PUBl.l( '/\TlON
`DITE
`PREV’. PAID ISSUIZ FEE
`'l U'l'Al_ l-'l’:'lLt[SI DIII1
`DATl'3 DUI?
`
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`05/12/2014
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`PTOL-85 (Rev. 02/11)
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`Page I of 3
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`JANSSEN EXHIBIT 2165
`
`Wockhardt v. Janssen lPR2016-01582
`
`JANSSEN EXHIBIT 2165
`Wockhardt v. Janssen IPR2016-01582
`
`
`
`PART B - FEE(S) TRANSMITTAL
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`02/1 1/2014
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`
`FIRST NAMED INVENTOR
`
`
`(’?ON'FIRMA'I'ION .\I().
`FILING DATE
`APPLICATION NO.
`I597
`Alan II. Auerbach
`O2/24/2011
`13/034,340
`CGRSOOIUSCNTI
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`APPLN. TYPE
`
`nonprovi siomil
`
`
`
`
`
`1iN'l'I'I'Y STATUS
`UNDISCOUNTED
`
`
`
`DUE
`
`ISSUE
`$960
`ART UNIT
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`
`
`PUlIl..lCA'1'lON 15151;‘ DUI.’
`PRIJV. PAID ISSUE
`'I'()'1'A.L l*'I."Ii(S) DUIS
`D/\'1'1i DUI;
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`$0
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`05/12/2014
`CLASS-SUB CLASS
`
`
`
`5l4~170()()0
`HUI. SAN MING R
`1621
`1. Change of correspondence address or indication of "Fe
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`CPR 1.363),
`Z. I-'or printing on the patent front page, list
`e Address" (37
`(I) The names of tip to 3 registered pzitent zittorneys
`l
`~
`---- -
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`or agents OR, alternatively,
`Address orm PTO/SB/122') attached.
`(2) The name ol‘ 2! single firm (having as a member ii
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`.2 registered patent attorneys or agents. If no name is
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`R egistraiion No. (_
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`Page 2 of 3
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`PTOL~85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office: US. DEPAR'l'Ml.iN'l‘ Oh CO.VlMER(‘Ii
`
`
`
`
`
`APPLICATION NO.
`
`l3/034,340
`
`
`
`UNl'l‘i£D S’l‘A'l‘]:‘S PA’l‘EN'i‘ AND TRADEMARK OFFICE
`
`
`
`FILING DATE
`
`02/24/201 1
`
`
`
`l’-'IRS'l” NAMED IN V iNTOR
`
`
`
`UNITED STATES DEPARTMENT OF COMMER('7E
`United States Patent and Trademark Olfice
`Address: CIOMMISSIONER FOR PATENTS
`P O. Box I450
`Alexandria. Virginia 233134450
`www usplo gov
`
`A'l"I’ORNEY DOCKET NO.
`
`C‘()Nl7lRMATlON NO.
`
`
`
`
`
`Alan ll. Auerbach
`
`CUR5()OlUSC.\lTl
`
`1597
`
`aw. sA~ Mme K
`
`1.521
`l)A'l'l:' MAlLl:'D: 02/l l/2014
`
`PHILIP s. JOHNSON
`JOHNSON & JOHNSON
`ONF, JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
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`l’TOL~85 (Rev. 02/l l)
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`
`
`Application No.
`13/034,340
`
`App|icant(s)
`AUERBACH ET AL.
`
`fgztinit J ,’.‘.',’.:,‘:',;*‘,‘.,'.,““°“‘°"°
`gzmimra HUI
`Notice ofAllowability
`- The MAILING DATE of this communication appears on the coversheet with the correspondence address—-
`
`No
`
`|_
`
`If not included
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`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. E This communication is responsive to 1/10/2014.
`I] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. E] 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. E The allowed claim(s) is/are 37-56. 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
`isttr ://www.us' to. ov/ atents/init extents/gait,/ir1dex_._j_s‘g; or send an inquiry to PPH:’eedback
`us to.<.'gov'
`.
`
`
`
`
`
`4. [:1 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (1).
`Certified copies:
`
`'0) [:1 None of the:
`b) [:1 Some
`a) D All
`1. [:1 Certified copies of the priority documents have been received.
`2. El Cenified copies of the priority documents have been received in Application No.
`3. E] 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 “MAlLlNG 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. [:1 CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`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 from (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. [:1 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. X information Disclosure Statements (PTO/SB/O8),
`Paper No./Mail Date
`3. [:1 Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. 1:] Interview Summary (PTO-413),
`Paper No./Mail Date
`
`/SAN—MING HUl/
`Primary Examiner, Art Unit 1621
`
`5. E] Examiner's Amendment/Comment
`6. E Examiner's Statement of Reasons for Allowance
`
`7. C] Other
`
`U 8 Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`
`, Notice oi Allowabilily
`
`Part of Paper No./Mail Date 20140128
`
`
`
`
`
`Application/Control Number: 13/034,340
`Art Unit: 1621
`
`Page 2
`
`The present application is being examined under the pre—AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office
`
`action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since
`
`this application is eligible for continued examination under 37 CFR 1.114, and the fee
`
`set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has
`
`been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 1/10/2014
`
`has been entered.
`
`REASONS FOR ALLOWANCE
`
`The following is an examiner’s statement of reasons for allowance: the herein
`
`claimed method of treating prostate cancer is essentially the same as the notice of
`
`allowance mailed 7/30/2013. The commercial success of the combination of prednisone
`
`and abiraterone to treat prostate cancer obviate the rejection under 35 USC 103(a).
`
`Claims 37—56 are allowed.
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`
`
`Application/Control Number: 13/034,340
`Art Unit: 1621
`
`Page 3
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAN—MING HUI whose telephone number is (571)272-
`
`0626. The examiner can normally be reached on Mon - Fri from 9:00 to 5:00.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Melenie McCormick can be reached on (571) 272-8037. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
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`
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`If you would like assistance from a
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/SAN-MING HUl/
`
`Primary Examiner, Art Unit 1621
`
`San-ming Hui
`Primary Examiner
`Art Unit 1621
`
`
`
`PTO/SB/08A (0800)
`Approved for use through 10/31/2002 OMB 0651-0031
`US. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
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`Agplication Number
`Filing Date
`First Named Inventor
`G’°“A"““'‘
`Examiner Name
`Attorney Docket Number
`U.S. PATENT DOCUMENTS
`
`13/034,340
`February 24, 2011
`Alan H. Auerbach
`‘629
`San Ming R. Hui
`CGR5001USCNT1
`
`US. Patent Document
`
`Examiner
`initials
`
`Cite
`
`Kind Code
`
`(gr known)
`
`Name of patemee or Applicant
`of Cited Document
`
`Date of Publication
`of Cited Document
`mmddgyyyy
`
`Pages, Columns, Lines.
`where relevant passages or
`relevant figures appear
`
`Examiner
`‘Ways
`
`Cite
`No‘
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`Substitute for f°lm1449A/PTO
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`STATEMENT BY APPLICANT
`("Se 35 “WV 5“°°'5 as "°°95“'Yi
`Sheet 1 of 2
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`Substitute for form 1449A/PTO
`Agp//Cation Number
`13/034340
`F/'lingDate
`Februa_ry 24, 2011
`First Named Inventor
`Alan H. Auerbach
`8,, M.,,,_w
`CGRSOO1 U SCNTt
`
`IN
`STATEMENT BY APPLICANT
`(“S9 as "‘°"Y Sm" 8‘ ""°°5“’Vl
`Sheet 2 of 2
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`OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS
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`include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item T“
`(book, magazine, journal, serial, symposium, catalog, etc), date, page(s), volume—issue number(s),
`publisher, city and/or country where published
`‘
`Berry, W. et al. Phase 111 Study ofMitoxantrone Plus Low Dose Prcdnisone Versus Low
`Dose Prednisonc Alone in Patients with Asymptornatic Hormone Relhictory Prostate Cancer,
`
`_r The Journal ofUro1ogy 2002_,_pages 2439-2443, Volume 168.
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`Chang, Ching-Yi, ct al. Glucocorticoids Manifest Androgcnic Activity in a Cell Derived from
`a Metastatic Prostate Cancer, Cancer Research, 2001, pages 8712-8717, Volume 61.
`Dorff, TB, Crawford, ED. Management and challenges ofcorticosteroid therapy in men with
`metastatic castrate-resistant prostate cancer, Annals ol‘ Oncology, 2013, pages 31 -8, Volume
`24(1).
`Efstathiou, Eleni, et al. Effects ofAbiraterone Acetate on Androgen Signaling in Castrate-
`Resistant Prostate Cancer in Bone, American Society of Clinical Oncology, Joumal of
`Clinical Oncolog, 2011, pages 1-8.
`Huggins, Charles, et al. Studies on Prostatic Cancer]. The liiffect ol‘Castration, ol‘Estrogen
`and of Androgen Injection on Serum Phosphatases in Metastatic Carcinoma of the Prostate,
`Cancer Research, 1941, pages 293-297, Volume 1.
`Mostaghel, EA. et al. Molecular Pathways: Targeting resistance in the androgen receptor for
`therapeutic benefit, Clin Cancer Res, 2013 Dec 4. Ep_uQ_aheaCl of priflg._
`Nishimura, Kazuo, et al. Potential Mechanism for the Effects ol’Dexarnethasone on Growth
`of Androgen-Indeperident Prostate Cancer, Journal of the National Cancer Institute, 2001,
`
`__
`
`l_
`
`_l_
`
`Tgages 1739-1746, Volume 93.
`
`+
`
`Oudar, Stephane, et al. Actualite dans le cancer de la prostate, Synthese, Bull Cancer 2005;
`92 (10), pgs. 865-873 (relevance in English abstract)
`Petrylak, et al. Docetaxel and Estramiistine Compared with Mitoxantrone and Prednisone
`for Advanced Refractory Prostate Canccr, The New [England Journal of Medicine, 2004,
`pages 1513-20, Volume 351.
`Ryan, et al., Aberaterone Acetate in Metastatic Prostate C anccr Without Previous
`___Chcmothcrapy; The New England Journal ol‘ Medicine, 2013, 368138-148.
`Sartor, et al, I\i)i3'til-'r)l”()Tlt‘I Prolongs Sinvivz-:1 in Metastzslii: l‘i'osi-alt: ifzzticr-i’,
`l‘~§iittirc l{evicws
`Clinical ()ncole,gy, ZOE 1, pages 515-16, Volume 8,
`Tannock, IF, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced
`prostate cancer, The New F/ngland Journal of Medicine, 2004, pages 1502-1512, Volume
`351(15).
`
`_4
`
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`
`,
`,
`Examiner
`
`/Sari Min Hail
`‘EXAMINER: lnitial it reference considered. whether or not citation is in colomiance with MPEP 609. Draw 1
`next nnmnuinii-.mnn tn appllr;-ml
`1 Unique citation designation nuniber. 2 Applicant is to place a check mark here i1Eng|isti language Translation is :itt:ir;tied
`Burden Hoiir Stateincrit This lurm is estiiriated to take 2 0 hours to mniplete. ‘fime will vary depending upon the needs of the individuzil case Any comments on the anouii ol time you are requred to
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`DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO‘ Commissioner for Patents, P O Box 1450, Alexandria, VA 22313-1450
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`,
`1
`~;ir
`Dt
`O:/139/2014
`ine through citation it not in mntoririance and not considered include copy oi this lorin with
`
`
`
`ALL REFERENCES CC>l\lSlDERED EXCEPT WHERE UNED THROUGH.
`
`/S.l-ii’
`
`
`
`Application/Control No.
`
`Index Of C/aims
`
`13034340
`
`Applicant(s)/Patent Under
`Reexamination
`AUERBACH ET AL.
`
`
`
`
`
`
`
`
`
`SAN-MING HUI
`
`1629
`
`
`Rejected
` Allowed
`
`-
`U
`[ —:-
`
`Cancelled
`Restricted
`
`IFN 1 Non-Elected
`“
`I
`I
`Interference Objected
`
` ‘
`C] Claims renumbered in the same order as presented by applicant
`
`E] CPA
`
`I] T.D.
`
`CLAIM
`
`Final
`
`Original
`
`1
`
`11/21/2011 I01/27/2012 09/05/2012 02/25/2013
`
`1___..
`
`2
`L_—
`1 J 3
`
`E] R.1.47
`
`-1
`
`DATE
`
`06/28/2013 10/21/2013 01/29/2014
`
`_J
`
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`’‘‘‘' —i"‘
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`
`367
`U S Patent and ‘ rademark Office
`
`i
`
`Part of Paper No.
`
`1
`
`: 20140128
`
`
`
`Index 01' Claims
`'
`I
`
`
`
`
`
`
`Rejected
`Allowed
`
`= H
`
`-
`-:-
`
`Application/Control No.
`
`Applicant(s)/Patent Under
`Reexamination
`
`13034340
`Examiner
`
`SAN—MlNG HUI
`
`AUERBACH ET AL.
`Art Unit
`
`1629
`
`‘J
`
`Cancelled
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`
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`’
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`I
`
`Non-Elected
`Interference
`
`A
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`
`Appeal
`Objected
`
`E] Claims renumbered in the sameorder as presented by applicant
`DATE
`F‘
`CLAIM —l
`Final
`Original 117/21/2011 01/27/201259‘/o5/2012[o2/25/20133528/253‘10/21/2013 01/29/2014
`37
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`US.PatentandTrademarkOffice
`
`PartofPaperNo.20140128
`
`
`
`AppIicant(s)/Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
`Application/Control No.
`
`Search NOTES
`
`13034340
`
`
`
`
`
`
`
`Examiner
`
`SAN—M|NG HUI
`
`CPC- SEARCHED
`
`Symboi
`
`Art Unit
`
`1628
`
`I
`
`Date
`
`Examiner‘;
`
`Examiner
`
`Examiner
`
`SH
`SH
`SH
`SH
`
`SH
`
`SH
`
`I
`
`I
`
`CPC COMBINATION SETS — SEARCHED
`
`L
`
`Symbol
`
`I
`
`Date
`
`Class
`
`F
`
`514
`I514
`__514
`514
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`W4
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`514
`
`I
`
`1 170,182
`170, 182
`170,182
`170, 182
`
`fl 170, 182
`
`170,182
`
`US CLASSIFICATION SEARCHED
`
`Subclass
`
`I
`
`Date
`
`1/27/11
`9/5/12
`2/25/13
`8/28/13
`
`10/21/13
`
`1/29/14
`
`
`
`SH
`SH
`SH
`
`SH
`SH
`
`Examiner
`
`SEARCH NOTES
`
`Search Notes
`EAST Search and inventor search in PALM
`EAST search and inventor search in PALM
`LEAST search and inventor search in PALM
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`LEAST search and inventor search in PALM
`
`Date
`1/27/11
`9/5/12
`2/25/18
`6/28/2013
`10/21/13
`1/29/14
`
`CPC Symbol
`
`US Class/
`L514
`
`514
`
`INTERFERENCE SEARCH
`
`US Subclass / CPC Group
`
`170,182
`
`170,182
`
`I
`fl
`
`Date
`6/28/13
`
`I 10/21/18
`
`Examiner
`SH
`
`SH
`
`US. F’a1en1 and Trademark Office
`
`Part of Paper No.
`
`. 20140128
`
`
`
`
`
`US Class/
`CPC Symbol
`514
`
`170,182
`
`INTERFERENCE SEARCH
`US Subclass / CPC Group
`
`Date
`1/29/14
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`Examiner
`SH
`
`I
`I
`J
`
`U S. Paiem and Trademark Office
`
`Pad of Paper No . 20140128
`
`
`
`Application/Control No.
`Issue Classification 13034340
`
`App|lcant(s)/Patent Under Reexamination
`AUERBACH ET AL.
`
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`/SAN-MING HU|/
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`Primary Examiner./\r1 UM1621
`
`Total Claims Allowed:
`
`20
`
`01/29/2014
`
`0 G. Print Ciaim(s)
`
`O.G. Prim Figure (Primary Examiner)
`
`1(Date) 1
`US. Patent and Trademark Office
`Pan of Paper No. 20140128
`
`
`
`
`
`
`
`
`
`
`
`
`
`Application/Control No. Applicant(s)/Patent Under Reexamination
`
`AUERBACH ET AL.
`Issue Classification
` 13034340
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`Examiner
` SAN~M|NG HUI
`
`US ORIGINAL CLASSIFICATION
`INTERNATIONAL CLASSIFICATION
` SUBCLASS NON-0'-WED
`514
`170
`1
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`31 / 56 (2006 O)
`
`CROSS REFERENCE(S)
`
`CLASS
`514
`
`SUBCLASS (ONE SUBCLASS PER BLOCK)
`
`r
`
`I80
`
`(Assistam Examiner)
`/SAN-MING HU|/
`
`Total Claims Allowed:
`
`20
`
`
`
`Primary Examiner./M Unit 1621
`01/29/2014
`O G. Prim C|aim(s)
`O,G. Prim Figure
`1 US. Paient and Trademark Office(Primary Examiner) (Dene) 1
`Pan of Paper No. 20140128
`
`
`
`
`
`
`
`
`
`Application/Control No.
`Issue Classification 13034340
`
`Applicant(s)/Patent Under Reexamination
`
`AUERBACH ET AL.
`
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