UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`27777
`
`7590
`
`02/1 l/2014
`
`EXAMINER
`
`PHILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA ‘
`NEW BRUNSWICK, NJ 08933-7003
`1621
`
`HUI, SAN MING R
`
`DATE MAILED: 02/1 1/2014
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Alan H. Auerbach
`02/24/2011
`13/034,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`CGR5001USCNT1
`
`1597
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`05/12/2014
`
`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
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
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`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
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`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
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`PTOL—85 (Rev. 02/11)
`
`Page 1 of 3
`
`<T>1,16<END1>1<END2>14<END3>(594,-14)<E4>22</E4>0<E5>1<E6>18<E7>11<E8>12/1/2015 12:00:00 AM16:12:31.7243394<E9></T>
`
`

`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or 1 (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
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
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`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any Change Ofaddress)
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`7590
`27777
`PHILIP J
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
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`02/11/2014
`
`NEW BRUNSWICK, NJ 08933-7003
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`Note: A certificate of mailin can only be used for domestic mailings of the
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`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Date)
`
`‘D°P°S“°"S W)
`(Signature)
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Alan H. Auerbach
`02/24/2011
`13/034,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`CGR5001USCNT1
`
`1597
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`HUI, SAN MING R
`
`$960
`
`1621
`
`$0
`
`$0
`
`$960
`
`05/12/2014
`
`514-170000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Vumber is required.
`
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`2. For printing on the patent front page, list
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`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
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`(A) NAME OF ASSIGNEE
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`3 Applicant certifying micro entity status. See 37 CFR 1.29
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`\IOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ 15A and 15B), issue
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`
`Authorized Signature
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`Date
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`Registration No.
`
`Page 2 of 3
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.goV
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/034,340
`
`02/24/2011
`
`Alan H. Auerbach
`
`CGR5001USCNT1
`
`1597
`
`PHILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`HUI, SAN MINGR
`
`1621
`
`DATE MAILED: 02/1 1/2014
`
`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
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`If a Continued Prosecution Application (CPA) was filed in the aboVe—identified application, the filing date that
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`PTOL—85 (Rev. 02/11)
`
`Page 3 of 3
`
`

`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`
`

`
`Notice of Allowability
`
`Application No.
`13/034,340
`gmjihi/136 HUI
`
`App|icant(s)
`AUERBACH ET AL.
`fgtzyn"
`’F‘:{;,<;‘,;S,‘,,',""°"‘°"°
`No
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL—85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IX This communication is responsive to 1/10/2014.
`
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. I:l 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 37-56. As a result of the allowed cIaim(s), you may be eligible to benefit from the Patent Prosecution
`in.
`Highway program at a participating intellectual property office for the corresponding application. For more information, please see
`hit’ :/'/wwwusrto. ov/ atents/'init events/'
`I1/ir1ciex.'s' or send an inquiry to r'PHfeedback us today.
`
`4. I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`Certified copies:
`
`a) I:l All
`
`b) D Some
`
`*c) I:I None of the:
`
`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(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. I] CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`
`I:I
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. I] 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. I] Notice of References Cited (PTO—892)
`
`2. IX] Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. I] Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] Interview Summary (PTO—413),
`Paper No./Mail Date
`
`/SAN—MING HUI/
`
`Primary Examiner, Art Unit 1621
`
`5. El Examiner’s Amendment/Comment
`
`6. IX Examiner’s Statement of Reasons for Allowance
`
`7. I:I Other
`
`.
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140128
`
`

`
`Application/Control Number: 13/034,340
`
`Page 2
`
`Art Unit: 1621
`
`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
`
`Page 3
`
`Art Unit: 1621
`
`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 —
`
`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`San—ming Hui
`Primary Examiner
`Art Unit 1621
`
`/SAN—MING HUI/
`
`Primary Examiner, Art Unit 1621
`
`

`
`PTO/SB/08A (08-00)
`Approved for use through 10/31/2002. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paenntork Reduction Act of 1995, no ersons are reuired to resond to a collection of information unless it disla s a valid OMB oontrol number.
`
`Substitute for form 1449A/PTO
`
`ABP]/bat/'On Nurnbef 1
`Film Date
`Februar 24, 2011
`
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`("aa as many ahaata aa naaaaaarvl
`Sheet 1 of 2
`
`Attorney Docket Number
`
`CGR5001USCNT1
`
`U.S. PATENT DOCUMENTS
`
`U.S. Patent Document
`
`Exammel
`mifials
`
`_
`
`Kmd Code
`(if known)
`
`-
`Name of Patemee or Applicant
`of Cited Document
`
`Date of Publication
`of Cited Document
`mm_dd_yyyy
`
`Pages, Columns, Lines,
`where relevant passages or
`relevant figures appear
`
`FOREIGN PATENT DOCUMENTS
`
`Foreign Patent Document
`T Name of patemee or
`
`Offices
`
`NUmber4 Kindcodes
`
`Applicant of Cited Document
`
`Date of Publication
`of Cited Document
`
`Pages, Columns, Lines,
`where relevant
`passages or relevant
`
`figures appear Sinature
`
`Considered—
`*EXAM|NER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
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`1 Unique citation designation number. 2See attached Kinds of U.S. Patent Documents. 3 Enter Office that issued the document, by the two-letter
`code (WIPO Standard ST.3). 4 For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial
`number ofthe patent document. 5 Kind of document bythe appropriate symbols as indicated on the document underW|PO Standard ST. 16 if
`possible. sApplicant is to place a check mark here if English language Translation is attached.
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`Cite
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`OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
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`
`Berry, W. et al. Phase 111 Study of Mitoxantrone Plus Low Dose Prednisone Versus Low
`Dose Prednisone Alone in Patients with Asymptomatic Hormone Refractory Prostate Cancer,
`The Journal ofUrolo , 2002, aes 2439-2443, Volume 168.
`Chang, Ching-Yi, et al. Glucocorticoids Manifest Androgenic 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 of corticosteroid therapy in men with
`metastatic castrate-resistant prostate cancer, Annals of Oncology, 2013, pages 31-8, Volume
`24(1).
`Efstathiou, Eleni, et al. Effects of Abiraterone Acetate on Androgen Signaling in Castrate-
`Resistant Prostate Cancer in Bone, American Society of Clinical Oncology, Journal of
`Clinical Oncology, 2011, pages 1-8.
`Huggins, Charles, et al. Studies on Prostatic Cancer.I. The Effect of Castration, of 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
`theraeutic benefit, Clin Cancer Res, 2013 Dec 4. E 0 ub ahead of 0 rint .
`Nishimura, Kazuo, et al. Potential Mechanism for the Effects of Dexamethasone on Growth
`of Androgen-Independent Prostate Cancer, Journal of the National Cancer Institute, 2001,
`aes 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 Estramustine Compared with Mitoxantrone and Prednisone
`for Advanced Refractory Prostate Cancer, The New England Journal of Medicine, 2004,
`pages 1513-20, Volume 351.
`Ryan, et al., Aberaterone Acetate in Metastatic Prostate Cancer Without Previous
`Chemotherapy, The New England Journal of Medicine, 2013, 368: 138-148.
`Sartor, et al, Ahiraterone Prolongs S'u1'vival in Metastatic: Prtastate Cancer, Nature Revievvs
`Clinical Oncolora r, 2011,
`515-16, Voiume 8.
`Tannock, IF, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced
`prostate cancer, The New England Journal of Medicine, 2004, pages 1502-1512, Volume
`
`1
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`Examiner
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`'
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`,
`,
`0=!aa/2014
`/Sani\/iini~ful/’
`*EXAM|NER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not considered. Include copy of this form with
`next communication to applicant.
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`

`
`Index Of C/aims
`
`13034340
`
`AUERBACH ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under
`Reexamination
`
`Examiner
`
`Art Unit
`
`SAN—M|NG HUI
`
`1629
`
`El Claims renumbered in the same order as presented by applicant
`
`I] 0 ‘U>
`
`CLAIM
`
`DATE
`
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`33
`
`34 2222222“
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`2222222“
`US. Patent and Trademark Office
`Part of Paper No.
`: 20140128
`
`

`
`Index Of C/aims
`
`13034340
`
`AUERBACH ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under
`Reexamination
`
`Examiner
`
`Art Unit
`
`SAN—M|NG HUI
`
`Non-Elected
`
`1629 Cancelled
`
`Allowed
`
`Restricted
`
`Interference
`
`Objected
`
`El Claims renumbered in the same order as presented by applicant
`
`El CPA
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`El T.D.
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`2222“
`2222“
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`
`US. Patent and Trademark Office
`
`Part of Paper No.
`
`: 20140128
`
`

`
`Application/Control No.
`
`Search NOTES
`
`13034340
`
`Applicant(s)/Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
`
`
`Examiner
`
`SAN-MING HUI
`
`
`
`Art Unit
`
`1323
`
`CPC- SEARCHED
`
`US CLASSIFICATION SEARCHED
`
`170,182
`
`1/29/14
`
`SEARCH NOTES
`
`‘
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`
`INTERFERENCE SEARCH
`
`US Classl
`
`CPC S mbol
`
`US Subclass / CPC Group
`
`170,182
`170,182
`
`6/28/13
`10/21/13
`
`US. Patent and Trademark Office
`
`Part of Paper No.
`
`: 20140128
`
`

`
`INTERFERENCE SEARCH
`
`
`US Classl
`CPC Symbol
`514
`
`170,182
`
`US Subclass / CPC Group
`
`Date
`
`Examiner
`
`1/29/14
`
`SH
`
`US. Patent and Trademark Office
`
`Part of Paper No.
`
`: 20140128
`
`

`
`Issue Classification 13034340
`
`AUERBACH ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii
`
`iiiiiii iii
`
`SAN—M|NG HUI
`
`1629
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`3%
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`(Assistant Examiner)
`/SAN-MING HU|/
`Primary Examiner.Art Unit 1621
`
`(Primary Examiner)
`US. Patent and Trademark Office
`
`Total Claims Allowed:
`
`20
`
`01/29/2014
`
`O.G. Print C|aim(s)
`
`O.G. Print Figure
`
`(Dam)
`
`1
`
`1
`Part of Paper No. 20140128
`
`

`
`Issue Classification 13034340
`
`AUERBACH ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii
`
`iiiiiii iii
`
`SAN—M|NG HUI
`
`1629
`
`US ORIGINAL CLASSIFICATION
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`INTERNATIONAL CLASSIFICATION
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`H-2-.‘
`‘ ‘
`11--
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`I...
`
`IIIIOIIIIO
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`
`Total Claims Allowed:
`
`20
`
`O.G. Print Figure (Primary Examiner)
`
`(Assistant Examiner)
`/SAN-MING HU|/
`Primary Examiner.Art Unit 1621
`
`US. Patent and Trademark Office
`
`01/29/2014
`
`O.G. Print C|aim(s)
`
`(Dam)
`
`1
`
`1
`Part of Paper No. 20140128
`
`

`
`Issue Classification 13034340
`
`AUERBACH ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii
`
`iiiiiii iii
`
`SAN—M|NG HUI
`
`1629
`
`IZ
`
`Claims renumbered in the same order as presented by applicant
`
`[I
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`[I
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`T.D
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`
`Final
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`Original
`
`Final
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`Original
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`Final
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`Original
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`Final
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`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Total Claims Allowed:
`
`20
`
`O.G. Print Figure (Primary Examiner)
`
`(Assistant Examiner)
`/SAN-MING HU|/
`Primary Examiner.Art Unit 1621
`
`US. Patent and Trademark Office
`
`01/29/2014
`
`O.G. Print C|aim(s)
`
`(Dam)
`
`1
`
`1
`Part of Paper No. 20140128
`
`

`
`EAST Search History
`
`EAST Search History
`
`EAST Search History (Prior Art)
`
`Default
`
`Plurals Time
`
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`cancer
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`1/29/2014 9:41 :34 AM
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`C:\Users\shui\Documents\EAST\Workspaces\13-034340.wsp
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`§2o14/01/29 09:40
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`file:///CI/Users/shui/Documents/e—Red%2OF01der/13034340/EASTSearchHist0ry.13034340_Accessib1eVersi0n.htm[