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.
`
`13/901,830
`
`ISSUE DATE
`
`11/03/2015
`
`PATENT NO.
`
`9173942
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`244168. 000007US9
`
`3806
`
`10/14/2015
`
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the
`Office of Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee
`payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Helsinn Healthcare S.A., Lugano, SWITZERLAND;
`Roche Palo Alto LLC, Palo Alto, CA;
`Simone Macciocchi, Melide, SWITZERLAND, Legal Representative;
`Giulio Macciocchi, Breganzona, SWITZERLAND, Legal Representative;
`Giorgio Calderari, Rancate, SWITZERLAND;
`Daniele Bonadeo, Casalzuigno, ITALY;
`Roberta Cannella, V arese, ITALY;
`Alberto Macciocchi, Melide, SWITZERLAND, Deceased;
`Andrew Miksztal, Palo Alto, CA;
`Thomas Malefyt, Carmel Valley, CA;
`Kathleen M. Lee, Palo Alto, CA;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`Dr. Reddy’s Laboratories, Ltd., et al.
`works to encourage and facilitate business investment. To learn more about why the USA is the best country in
`v.
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1002
`
`IR103 (Rev. 10/09)
`
`

`
`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.
`
`13/901,830
`
`ISSUE DATE
`
`11/03/2015
`
`PATENT NO.
`
`9173942
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`244168. 000007US9
`
`3806
`
`10/14/2015
`
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the
`Office of Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee
`payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Helsinn Healthcare S.A., Lugano, SWITZERLAND;
`Roche Palo Alto LLC, Palo Alto, CA;
`Simone Macciocchi, Melide, SWITZERLAND, Legal Representative;
`Giulio Macciocchi, Breganzona, SWITZERLAND, Legal Representative;
`Giorgio Calderari, Rancate, SWITZERLAND;
`Daniele Bonadeo, Casalzuigno, ITALY;
`Roberta Cannella, V arese, ITALY;
`Alberto Macciocchi, Melide, SWITZERLAND, Deceased;
`Andrew Miksztal, Palo Alto, CA;
`Thomas Malefyt, Carmel Valley, CA;
`Kathleen M. Lee, Palo Alto, CA;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage and facilitate business investment. To learn more about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`
`IR103 (Rev. 10/09)
`
`Exh. 1002
`
`

`
`Rece· d
`IPt ate: 05/24/2013
`
`13901830 GAU 1628
`-
`Complete if Known
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`I
`I
`of
`1
`
`I
`
`Sheet
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`12
`
`Giorgio Calderari
`
`23278.2.US.9
`
`Examiner
`Initials
`
`Cite
`No. 1
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`Document Number
`Number-Kind Code2 (if known)
`US-5,272, 137
`
`U.S. PATENTS
`Issue or
`Name of Patentee or
`Publication Date
`Applicant of Cited Document
`MM-DD-YYYY
`12-00-1993
`
`Blase eta!.
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`US-4,695,578
`
`US-4,753,789
`
`US-4,886,808
`
`US-4,906, 755
`
`US-4,929,632
`
`US-4,937,247
`
`US-5,011 ,846
`
`US-5,034,398
`
`US-5,240,954
`
`US-5,344,658
`
`US-5,578,628
`
`09-22-1987
`
`Coates eta!.
`
`06-28-1988
`
`Tyers et al.
`
`12-12-1989
`
`King
`
`03-06-1990
`
`Gittos
`
`05-29-1990
`
`Tyers et al.
`
`06-26-1990
`
`King
`
`04-30-1991
`
`Gittos et al.
`
`07-23-1991
`
`King
`
`08-31-1993
`
`Tyers et al.
`
`09-06-1994
`
`Collin
`
`11-26-1996
`
`Tyers et al.
`
`11-26-1996
`
`Tyers et al.
`
`aoolie(
`nt
`
`Change(
`5
`to docum
`
`/K.s.s
`9/27/20 11-'i
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`US-5,578,632
`
`US-5,622,720
`US-5,922,749 OJ/1999
`U S-5, 955,488
`
`US-6,063,802
`
`US-6,294,548
`
`US-5,854,270
`
`US-5,202,333
`
`US-6,287,592
`
`US-6,284,749
`
`US-6,132,758
`
`US-6,699,852
`
`US-7,109,339
`
`US-7,947,724
`
`US-7,947,725
`
`US-7,960,424
`
`04-22-1997
`
`Collin
`
`B? 18 1887
`
`Tyers et al.
`
`09-21-1999
`
`Winterborn
`
`05-16-2000
`
`Winterborn
`
`09-25-2001
`
`James
`
`12-29-1998
`
`Gambhir
`
`04-13-1993
`
`Berger eta!.
`
`09-11-2001
`
`Dickinson
`
`09-04-2001
`
`Castillo et al.
`
`10-17-2000
`
`03-02-2004
`
`09-19-2006
`
`05-14-2011
`
`Farah J. Munayyer et al.
`(Schering Corporation)
`Albert Robichaud (Bristol-Myers
`Squibb Pharma Co.)
`Tackyu Lee et al. (Bristol-Myers
`Squibb Company)
`Giorgio Calderari, eta!.
`
`05-14-2011
`
`Giorgio Calderari et al.
`
`06-14-2011
`
`Giorgio Calderari et al.
`
`5582040v1
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.G./
`
`Exh. 1002
`
`

`
`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
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/901,830
`
`05/24/2013
`
`Giorgio Calderari
`
`244168.000007US9
`
`3806
`
`6980
`7590
`09/04/2015
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`GEMBEH, SHIRLEY V
`
`ART UNIT
`
`1628
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/04/2015
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`j im.schutz@ troutmansanders .com
`ryan. schneider@ troutmansanders. com
`patents@ troutmansanders. com
`
`PTOL-90A (Rev. 04/07)
`
`Exh. 1002
`
`

`
`UNITED STATES DEPARTMENT OF COMMERCE
`U.S. Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`APPLICATION NO./
`CONTROL NO.
`13/901,830
`
`FILING DATE
`
`24May, 2013
`
`FIRST NAMED INVENTOR I
`PATENT IN REEXAMINATION
`CALDERARI ET AL.
`
`A HORNEY DOCKET NO.
`
`244168.000007US9
`
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`SHIRLEY V. GEMBEH
`
`ART UNIT
`
`PAPER
`
`1628
`
`20150901
`
`DATE MAILED:
`
`Please find below and/or attached an Office communication concerning this application or
`proceeding.
`
`The information disclosure statement (IDS) submitted on 3/27/14 have been received and acknowledged
`
`Commissioner for Patents
`
`/SHIRLEY V GEMBEH/
`Primary Examiner, Art Unit 1628
`
`PT0-90C (Rev.04-03)
`
`Exh. 1002
`
`

`
`Application/Control No.
`Issue Classification 13901830
`Examiner
`
`SHIRLEY V GEMBEH
`
`I IIIII
`
`CPC
`Symbol
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`8658
`
`8658
`
`::::::::::: 47
`::::::::::: 47
`::::::::::: 47
`47
`
`•:•:•:•:•:•
`
`•:•:•:•:•:•
`
`•:•:•:•:•:•
`
`31
`
`47
`
`9
`
`•:•:•:•:•:•
`
`9
`•:•:•:•:•:•
`::::::::::: 7
`::::::::::: 55
`:::::::::::
`
`:::::::::::
`
`:•:•:•:•:•:
`
`:•:•:•:•:•:
`
`:•:•:•:•:•:
`
`CPC Coml"''"'"v" Sets
`Symbol
`
`[:::::::::
`
`[:•:•:•:•:
`
`:•:•:~:•:•• 26
`:•:•:~:•:•• 183
`:•:•:~:•:•• 12
`
`·····~····· 00
`·····~····· 473
`·····~····· 02
`·····~····· 0019
`·····~····· 0095
`•:•:•~•:•:• 16
`•:•:•~•:•:• 02
`•:•:•~•:•:•
`•:•:•~•:•:•
`·····~·····
`·····~·····
`·····~·····
`
`•:•:•~•:•:•
`·····~·····
`
`Applicant(s)/Patent Under Reexamination
`
`CALDERARI ET AL.
`
`Art Unit
`
`1628
`
`Type
`
`Version
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`F
`
`I
`
`I
`
`I
`
`I
`
`I
`
`I
`
`I
`
`I
`
`I
`
`Type
`
`Set
`
`....
`
`nCIII"III!:j
`
`Version
`
`NONE
`
`(Assistant Examiner)
`/SHIRLEY V GEM8EH/
`Primary Examiner.Art Unit 1628
`
`(Primary Examiner)
`
`U.S. Patent and Trademark Office
`
`(Date)
`
`7/27/15
`
`(Date)
`
`Total Claims Allowed:
`
`19
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`1
`
`NONE
`
`Part of Paper No. 20t5090t
`
`Exh. 1002
`
`

`
`Application/Control No.
`Issue Classification 13901830
`Examiner
`
`I IIIII
`
`SHIRLEY V GEMBEH
`
`Applicant(s)/Patent Under Reexamination
`
`CALDERARI ET AL.
`
`Art Unit
`
`1628
`
`US ORIGINAL CLASSIFICATION
`
`CLASS
`
`SUBCLASS
`
`514
`
`397
`
`INTERNATIONAL CLASSIFICATION
`
`A
`
`0
`
`1
`
`CLAIMED
`43 I 52 (2006.01.01)
`N
`
`NON-CLAIMED
`
`CROSS REFERENCE(S)
`
`CLASS
`
`SUBCLASS {ONE SUBCLASS PER BLOCK)
`
`NONE
`
`(Assistant Examiner)
`/SHIRLEY V GEMBEH/
`Primary Examiner.Art Unit 1628
`
`(Primary Examiner)
`
`U.S. Pa1en1 and Trademark Office
`
`(Date)
`
`7/27/15
`
`(Date)
`
`Total Claims Allowed:
`
`19
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`1
`
`NONE
`
`Par1 of Paper No. 20150901
`
`Exh. 1002
`
`

`
`Application/Control No.
`Issue Classification 13901830
`Examiner
`
`I IIIII
`
`SHIRLEY V GEMBEH
`
`Applicant(s)/Patent Under Reexamination
`
`CALDERARI ET AL.
`
`Art Unit
`
`1628
`
`D
`
`Claims renumbered in the same order as presented by applicant
`
`D
`
`CPA
`
`~ T.D.
`
`D
`
`R.1.47
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`17
`
`18
`
`19
`
`42
`
`43
`
`44
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`26
`
`27
`
`28
`
`29
`
`30
`
`31
`
`32
`
`33
`
`34
`
`35
`
`36
`
`37
`
`38
`
`39
`
`40
`
`41
`
`NONE
`
`(Assistant Examiner)
`/SHIRLEY V GEMBEH/
`Primary Examiner.Art Unit 1628
`
`(Primary Examiner)
`
`U.S. Patent and Trademark Office
`
`(Date)
`
`7/27/15
`
`(Date)
`
`Total Claims Allowed:
`
`19
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`1
`
`NONE
`
`Part of Paper No. 20t5090t
`
`Exh. 1002
`
`

`
`Receipt date: 03/27/2014
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`I
`I
`1
`of
`
`I
`
`Sheet
`
`13901830 - GAU: 1628
`Complete if Known
`13/901,830
`May 24, 2013
`Giorgio CALDERARI
`1628
`Shirley V. GEMBEH
`244168.000007. US.9
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`2
`
`Examiner
`Initials
`
`Cite
`No. 1
`
`36
`
`37
`
`38
`
`Examiner
`Initials
`
`Cite
`No. 3
`
`39
`
`40
`
`41
`
`42
`
`Document Number
`Number-Kind Code2
`US-8,518,981
`
`(if known)
`
`U.S. PATENTS
`Issue or
`Name of Patentee or
`Publication Date
`Applicant of Cited Document
`MM-DD-YYYY
`08-27-2013
`
`Calderari et al.
`
`US-8,598,218
`
`US-8,598,219
`
`12-3-2013
`
`12-3-2013
`
`Calderari et al.
`
`Calderari et al.
`
`U.S. PUBLISHED PATENT APPLICATIONS
`Document Number
`Issue or
`Name of Patentee or
`Publication Date
`Applicant of Cited Document
`Number-Kind Code 4
`MM-DD-YYYY
`US-2013/0261149
`10-03-2013
`
`Calderari et al.
`
`(if known)
`
`US-2013/0261150
`
`US-2013/0289065
`
`US-2014/0039000
`
`10-03-2013
`
`Calderari et al.
`
`10-31-2013
`
`Calderari et al.
`
`02-06-2014
`
`Calderari et al.
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`43
`US-2004/0147510
`07-29-2004
`Landau et al.
`Note: Submission of copies of U.S. Patents and published U.S. Patent Applications is not required.
`
`Examiner
`Initials
`
`Cite
`No. 1
`
`Foreign Patent Document
`
`Country Code5 Number6 Kind Code7 (if known)
`
`FOREIGN PATENT DOCUMENTS
`Pages, Columns, Lines,
`Publication Date
`Name of Patentee or
`Applicant of Cited Document Where Relevant Passages
`MM-DD-YYYY
`or Relevant Figures
`Appear
`
`Translation"
`
`Examiner
`Initials
`
`NONPATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`February 9, 2009 Bonadeo Declaration.
`
`Cite
`No. 1
`
`343
`
`Translation 6
`
`546
`
`748
`
`751
`
`Perez, et al., Comparable safety and antiemetic efficacy of a brief (30-second bolus) intravenous granisetron
`infusion and a standard (15-minute) intravenous ondansetron infusion in breast cancer patients receiving
`moderately emetogenic chemotherapy. Cancer J. Sci. Am. Vol. 4, No 1, pp. 52-8, 1998.
`Bedford Laboratories division of Ben Venue Laboratories, Inc. Paragraph IV Letter regarding U.S. Patent
`Nos. 7,947,724, 7,947,725, and 7,960,424, dated August 13, 2013.
`Aurobindo Pharma Ltd. Paragraph IV notice regarding U.S. Patent No. 8,518,981, dated September 19,
`2013.
`Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Laboratories, Inc.'s Amended Invalidity Contentions
`Pursuant to L. Pat. R. 3.6(c), dated July 8, 2013 (D.N.J. Case Nos. 11-3962 and 11-5579; consolidated).
`Sandoz Inc.'s Second Amended Invalidity Contentions Pursuant to L. Pat. R. 3.7, dated July 5, 2013 (D.N.J.
`Case Nos. 11-3962 and 11-5579; consolidated) (confidentiality designation and other portions redacted).
`Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.'s First Amended
`Invalidity Contentions Pursuant to L. Pat. R. 3.6(c), dated July 5, 2013 (D.N.J. Case Nos. 11-3962 and 11-
`5579; consolidated) (confidentiality designation redacted).
`758 Opening Expert Report of Dr. Bert Spilker, dated September 9, 2013 (D. N.J. Case Nos. 11-3962 and 11-
`5579; consolidated) (confidentiality designation and other portions redacted).
`Expert Report of David G. Frame, Pharm.D., dated September 5, 2013 (D.N.J. Case Nos. 11-3962 and 11-
`5579; consolidated) (confidentiality designation and other portions redacted).
`Expert Report of Lee Kirsch, Ph.D., dated September 9, 2013 (D.N.J. Case Nos. 11-3962 and 11-5579;
`consolidated) (confidentiality designation and other portions redacted).
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.G./
`
`752
`
`754
`
`756
`
`759
`
`760
`
`Exh. 1002
`
`

`
`Receipt date: 03/27/2014
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`I
`I
`of
`2
`
`I
`
`Sheet
`
`13901830 - GAU: 1628
`Complete if Known
`13/901,830
`May 24, 2013
`Giorgio CALDERARI
`1628
`Shirley V. GEMBEH
`244168.000007. US.9
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`2
`
`761
`
`762
`
`763
`
`765
`
`766
`
`767
`
`768
`
`769
`
`770
`
`771
`
`772
`
`773
`774
`
`775
`
`776
`
`777
`
`778
`
`782
`
`783
`
`784
`
`785
`
`786
`
`NONPATENT LITERATURE DOCUMENTS
`Expert Report of Patrick P. Deluca, Ph.D., dated September 9, 2013 (D.N.J. Case Nos. 11-3962 and 11-
`5579; consolidated) (confidentiality designation and other portions redacted).
`Expert Report of Paul Myrdal, Ph.D., dated September 9, 2013 (D.N.J. Case Nos. 11-3962 and 11-5579;
`consolidated) (confidentiality designation and other portions redacted).
`Complaint for patent infringement filed by Helsinn Healthcare S.A. and Roche Palo Alto LLC against
`Ben Venue Laboratories, Inc. d/b/a Bedford Laboratories regarding U.S. Patent Nos. 7,947,724, 7,947,725,
`7,960,424, and 8,518,981 dated September 25,2013 (D. Del. Case No. 13-1612).
`Reply Expert Report of Patrick P. Deluca, Ph.D., dated November 22, 2013 (D.N.J. Case Nos. 11-3962 and
`11-5579; consolidated) (confidentiality designation redacted).
`Reply Expert Report of David G. Frame, Pharm. D., dated November 27, 2013 (D.N.J. Case Nos. 11-3962
`and 11-5579; consolidated) (confidentiality designation redacted).
`Reply Expert Report of Jack Geltosky, Ph.D., dated November 22, 2013 (D. N.J. Case Nos. 11-3962 and
`11-5579; consolidated) (confidentiality designation and other portions redacted).
`Reply Expert Report of Lee Kirsch, Ph.D., dated November 22, 2013 (D. N.J. Case No. 11-3962 and
`11-5579; consolidated) (confidentiality designation redacted).
`Reply Expert Report of Paul Myrdal, Ph.D., dated November 22, 2013 (D.N.J. Case No. 11-3962 and
`11-5579; consolidated) (confidentiality designation redacted).
`Reply Expert Report of Dr. Bert Spilker, dated November 22, 2013 (D.N.J. Case No. 11-3962 and 11-5579;
`consolidated) (confidentiality designation and other portions redacted).
`Accord Healthcare, Inc. Paragraph IV Letter regarding U.S. Patent No. 8,518,981 dated October 2, 2013
`(portions redacted).
`Bedford Laboratories division of Ben Venue Laboratories, Inc. Paragraph IV Letter regarding U.S. Patent
`No. 8,518,981 dated October 16, 2013 (portions redacted).
`Sandoz Inc. Paragraph IV Letter regarding U.S. Patent No. 8,518,981 dated December 16, 2013.
`Aurobindo Pharma Ltd. Paragraph IV Letter regarding U.S. Patent Nos. 8,598,218 and 8,598,219 dated
`January 21, 2014 (portions redacted).
`Sandoz Inc. Paragraph IV Letter regarding U.S. Patent Nos. 8,598,218 and 8,598,219 dated February 3,
`2014 (portions redacted).
`Bedford Laboratories division of Ben Venue Laboratories, Inc. Paragraph IV Letter regarding U.S. Patent
`Nos. 8,598,218 and 8,598,219 dated February 6, 2014 (portions redacted).
`Defendants Aurobindo Pharma Ltd.'s and Auromedics Pharma LLC's Amended Answer, Affirmative
`Defenses, and Counterclaims regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, 8,518,981,
`8,598,218, and 8,598,219, dated February 11,2014 (D. Del. Case No. 13-688).
`Ben Venue Laboratories, Inc.'s Answer and Counterclaims to Amended Complaint regarding U.S. Patent
`Nos. 7,947,724, 7,947,725, 7,960,424, 8,518,981, 8,598,218, and 8,598,219, dated February 24,2014 (D.
`Del. Case No. 13-1612).
`Complaint for Patent Infringement filed by Helsinn Healthcare S.A. and Roche Palo Alto LLC against Accord
`Healthcare, Inc. and lntas Pharmaceuticals Ltd regarding U.S. Patent Nos. 8,598,218 and 8,598,219 dated
`December 27,2013 (D. Del. Case No. 13-2101).
`Cipla Limited Paragraph IV Letter regarding U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, 8,518,981,
`8,598,218, and 8,598,219 dated February 24, 2014 (portions redacted).
`Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Laboratories, Inc.'s Invalidity Contentions regarding U.S.
`Patent Nos. 8,518,981, 8,598,218, and 8,598,219 dated March 17,2014 (D.N.J. Case No. 13-5815)
`(confidentiality designation and other portions redacted).
`Sandoz Inc.'s Invalidity Contentions Pursuant to L. Pat. R. 3.3 and 3.6(c) regarding U.S. Patent Nos.
`8,518,981, 8,598,218, and 8,598,219 dated March 17, 2014 (D. N.J. Case No. 13-5815) (confidentiality
`designation and other portions redacted).
`Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.'s Invalidity Contentions Pursuant
`to L. Pat. R. 3.6(c) regarding U.S. Patent Nos. 8,518,981, 8,598,218, and 8,598,219 dated March 17, 2014
`(D. N.J. Case No. 13-5815) (confidentiality designation and other portions redacted).
`
`iShirley Gembeh/ (04i09/2014)
`
`Date
`Considered
`
`EXAMINER: 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.G./
`
`Exh. 1002
`
`

`
`UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`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
`
`08/25/2015
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`GEMBEH, SHIRLEY V
`
`ART UNIT
`
`1628
`
`PAPER NUMBER
`
`DATE MAILED: 08/25/2015
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Giorgio Calderari
`05/24/2013
`13/901,830
`TITLE OF INVENTION: LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`244168,000007US9
`
`3806
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`DATE DUE
`
`11/25/2015
`
`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:
`
`L Review the ENTITY STATUS shown above, If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies,
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above,
`If the ENTITY STATUS is changed from that shown above, on PART B- FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)",
`For purposes of this notice, small entity fees are l/2 the amount of undiscounted fees, and micro entity fees are l/2 the amount of small entity
`fees,
`
`IL PART B- FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required), If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted, If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B,
`
`IlL 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)
`
`Pagel of3
`
`Exh. 1002
`
`

`
`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 l 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 l, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`6980
`7590
`08/25/2015
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`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.
`
`Giorgio Calderari
`05/24/2013
`13/901,830
`TITLE OF INVENTION: LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`244168. 000007US9
`
`3806
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`DATE DUE
`
`ll/25/2015
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`GEMBEH, SHIRLEY V
`
`1628
`
`514-397000
`
`l. Change of correspondence address or indication of "Fee Address" (37
`2. For printing on the patent front page, list
`CFR 1.363).
`( l) The names of up to 3 registered patent attorneys
`0 Change of correspondence address (or Change of Correspondence
`or agents OR, alternatively,
`Address form PTO/SB/122) attached.
`(2) The name of a single firm (having as a member a
`0 "Fee Address" indication (or "Fee Address" Indication form
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`listed, no name will be printed.
`Number is required.
`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.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`3 ________________________ _
`
`2 ________________________ _
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : 0 Individual 0 Corporation or other private group entity 0 Government
`4b. Payment ofFee(s): (Please first reapply any previously paid issue fee shown above)
`4a. The following fee(s) are submitted:
`0 Issue Fee
`0 A check is enclosed.
`0 Publication Fee (No small entity discount permitted)
`0 Payment by credit card. Form PT0-2038 is attached.
`0 The director is hereby authorized to charge the required fee( s ), any deficiency, or credits any
`0 Advance Order- #of Copies _________ __
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`5. Change in Entity Status (from status indicated above)
`0 Applicant certifying micro entity status. See 37 CFR 1.29
`0 Applicant asserting small entity status. See 37 CFR 1.27
`0 Applicant changing to regular undiscounted fee status.
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/l5A and l5B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature _______________________ _
`
`Date ____________________ _
`
`Typed or printed name ______________________ __
`
`Registration No. ________________ _
`
`PTOL-85 Part B (10-13) Approved for use through 10/3112013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 2 of3
`
`Exh. 1002
`
`

`
`UNITED STA 1ES p A 1ENT 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.
`
`13/901,830
`
`05/24/2013
`
`Giorgio Calderari
`
`244168.000007US9
`
`3806
`
`08/25/2015
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`GEMBEH, SHIRLEY V
`
`ART UNIT
`
`1628
`
`PAPER NUMBER
`
`DATE MAILED: 08/25/2015
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`Section 1(h)(2) of the AlA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CPR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0 101 or (571 )-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of3
`
`Exh. 1002
`
`

`
`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