`

`INTERNATIONAL SEARCH REPORT
`
`lntematlonal appllcatlon No
`PCT/EP2006/069974
`
`A. CLASSIACATION / ( SUBJECT MATTER
`INV. A61K39 09
`
`According to International Patent Classification (IPC) or to both national classification and IPC
`
`B. FIELDS SEARCHED
`Minimum documentation searched (dassification system foffowed by classification symbols)
`A61K
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`EPO-Internal, WPI Data, BIOSIS
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category• Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to daim No.
`
`y
`
`DAGAN RON ET AL: "Tolerability and
`immunogenicity of an eleven valent mixed
`carrier Streptococcus pneumoniae capsular
`polysaccharide-diphtheria toxoid.or
`tetanus protein conjugate vaccine in
`Finnish and Israeli infants. II
`PEDIATRIC INFECTIOUS DISEASE JOURNAL,
`vol. 23, no. 2, February 2004 (2004-02),
`pages 91-98, XP008080213
`ISSN: 0891-3668
`the whole document
`
`-----
`
`-!--
`
`1-10,
`114-129,
`132-136
`
`[!] Further documents are listed in the continuation of Box C.
`
`I[) See patent family annex.
`
`• Special categories of cited documents :
`
`•A• document defining the general state of the art which is not
`considered to be of particular relevance
`"E" earlier document but published on or after the international
`filing date
`"L" document which may throw doubts on priority daim(s) or
`which is cited to establish the publication date of another
`citation or other special reason (as specified)
`·o· document referring to an oral disclosure, use, exhibition or
`other means
`•p• document published prior to the international filing date but
`later than the priority date claimed
`
`"T" later document published after the international filing date
`or priority date and not in conflict with the application but
`cited to understand the principle or theory underlying the
`invention
`•x• document of particular relevance; the claimed invention
`cannot be considered novel or cannot be considered to
`involve an inventive step when the document is taken alone
`•y• document of particular relevance; the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or more other such docu-
`ments, such combination being obvious to a person skilled
`in the art.
`"&" document member of the same patent family
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`21 June 2007
`
`Name and mailing address of the ISA/
`European Patent Office, P.B. 5818 Patentlaan 2
`NL - 2280 HV Rijswijk
`Tel. (+31-70) 340-2040, Tx. 31 651 epo nl,
`Fax: (+31-70) 340-3016
`
`Form PCT /ISA/21 o (second sheet) (April 2005)
`
`16/07/2007
`
`Authorized officer
`
`MONTERO LOPEZ, B
`
`page 1 of 2
`
`Ex. 1028-0386
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International appllcaUon No
`PCT/EP2006/069974
`
`C(ConUnuatlon). DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category• Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`Y
`
`A
`
`A
`
`"Immune
`SIGURDARDOTTIR SIGURVEIG T ET AL:
`response to octavalent diphtheria- and
`tetanus-conjugated pneumococcal vaccines
`is serotype- and ·carrier-specific: the
`-choice for a mixed carrier vaccine."
`THE PEDIATRIC INFECTIOUS DISEASE JOURNAL
`JUN 2002,
`vol. 21, no. 6, June 2002 (2002-06), pages
`548-554, XP008080212
`ISSN: 0891-3668
`the whole document
`
`WO 02/080965 A (GLAXOSMITHKLINE BIOLOG SA
`[BE]; BOUTRIAU DOMINIQUE [BE]; CAPIAU
`CARINE) 17 October 2002 (2002-10-17)
`page 7, line 1 - page 8, line 16
`page 9, line 12 - page 10, line 11
`page 11, line 19 - page 12, line 6
`page 17, line 22 -
`line 33
`page 18, line 18 -
`line 30; examples 4,5
`
`US 2003/099672 Al (SCHULTZ DOMINIQUE [FR])
`29 May 2003 (2003-05-29)
`page 1, paragraph 7 - paragraph 12
`page 1, paragraph 17
`page 3, paragraph 32 - page 4, paragraph
`35
`page 4, paragraph 38 - page 5, paragraph
`44
`page 5, paragraph 52 - page 7, paragraph
`66
`
`1-10,
`114-129,
`132-136
`
`1-10,
`114-136
`
`1-10,
`114-116
`
`Fonn PCT/ISA/210 (continuation of second sheet) (April 2005)
`
`page 2 of 2
`
`Ex. 1028-0387
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`· PCT/EP2006/069974
`
`Box II Observations where certain ciaims were found unsearchable (Continuation of item 2 of first sheet)
`
`This International Search Report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:
`
`1. [iJ Claims Nos.:
`because they relate _to subject matter not required to be searched by this Authority, namely:
`Although claims 117-122 and 131-148 are directed to a method of treatment of
`the human/animal body, the search has been carried out and based on the
`alleged effects of the composition.
`2. [!J ClalmsNos.:
`11-113, 137-148
`·
`·
`·
`·
`because they relate to parts of the International Application that do not comply with the prescribed requirements to such
`an extent that no meaningful International Search can be carried out, specifically:
`see FURTHER INFORMATION sheet PCT/ISA/210
`
`3. D Claims Nos.:
`
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`Box Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`1. D As all required additional search fees were timely paid by the applicant, this International Search Report covers all
`
`searchable claims.
`
`2. D As all searchable claims could be searched without effort Justifying an additional lee, this Authority did not invite payment
`
`of any additional fee.
`
`3. O As only some ot the required additional search tees were timely paid by the applicant, this lntemat!ona\ Search Report
`
`covers only those claims for which fees were paid, specifically claims Nos.:
`
`4. D No required additional search fees were timely paid by the applicant. Consequently, this International Search Report is
`
`restricted to the invention first mentioned in the claims; it is covered by claims Nos.:
`
`Remark on Protest
`
`D The additional search fees were accompanied by the applicant's protest.
`D No protest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (January 2004)
`
`Ex. 1028-0388
`
`

`

`International Application No. PCT/EP2006 /069974
`
`FURTHER INFORMATION coNYiNuEo· FROM PcTnsAJ 21 o
`
`Continuation of Box II.I
`
`Although claims 117-122 and 131-148 are directed to a method of., -
`treatment of the human/animal body, the search has been carried out and
`based on the alleged effects of the composition.
`
`Continuation of Box II.2
`
`Claims Nos.: 11-113, 137-148
`
`The present application contains 148 claims. There are so many dependent
`claims, and they are drafted in such a way that the claims as a whole
`are not in compliance with the provisions of clarity and conciseness of
`Article 6 PCT, as they erect a smoke. screen in front of the skilled
`reader when assessing what should be the subject-matter to search. The
`non-compliance with the substantive provisions·is to such an extent,
`that the search was performed taking into consideration the
`non-compliance in determining the extent of the search (PCT Guidelines
`9.19).
`
`.
`
`'
`
`'
`
`.
`
`The extent of the search was consequently limited to claims 1-10, and
`claims 114-136 as far as depending on claims 1-10, which appear/s to
`comprise a reasonable ·definition of what is understood to be the
`invention for which protection is sought.
`
`The applicant's· attention is drawn to the fact that claims relating to
`inventions in respect of which no international search report has been
`established need not be the subject of an international preliminary
`examination (Rule 66.l(e) PCT). The applicant is advised that the EPO
`policy when acting as an International Preliminary Examining Authority is
`normally not to carry out a preliminary examination on matter which has
`not been searched. This is the case irrespective of whether or not the
`claims are amended following receipt of the search report or during any
`Chapter II procedure. If the application proceeds into the regional phase
`before the EPO, the applicant is reminded that a search may be carried
`out during examination before the EPO (see EPO Guideline C-VI, 8.5),
`should the problems which led to the Article 17(2) declaration be
`overcome.
`
`Ex. 1028-0389
`
`

`

`INTERNATIONAL SEARCH REPORT
`Information on patent famlly members
`
`International application No
`PCT/EP2006/069974
`
`Patent family
`member(s)
`
`date
`
`I Publication
`
`I
`
`. -
`
`WO 02080965
`
`BR
`21-02-2006
`PI0208595 A
`17-10-2002
`2442865 Al
`CA
`17-11-2004
`1547485 A
`CN
`15-12-2004
`20032698 A3
`CZ
`1390066 A2
`25-02-2004
`EP
`HU
`0303996 A2
`01-03-2004
`2005508849 T
`07-04-2005
`JP
`MX
`PA0300896 l A .
`12-02-2004
`20034410 A
`25-11-2003
`NO
`15-07-2003
`76952 C2
`UA
`us
`2004202668 Al
`14-10-2004
`200307640 A
`23-05-2005
`ZA
`----------------------------------------------·------------------------
`us 2003099672 Al
`15-07-2005
`29-05-2003
`AT
`297758 T
`4427501 A
`24-09-2001
`AU
`20-09-2001
`CA
`2402807 Al
`21-07-2005
`DE
`60111507 Dl
`60111507 T2
`11-05-2006
`DE
`EP
`1267922 Al
`02-01-2003
`16-10-2005
`ES
`2240432 T3
`FR
`21-09-2001
`2806304 Al
`20-09-2001
`WO
`0168128 Al
`1267922 T
`30-09-2005
`PT
`-----------------------------------------------------------------------
`
`Patent document
`cited in search report
`
`date
`
`I Publication
`
`A
`
`17-10:-2002
`
`Form PCT/ISA/210 (patent family annex) (April 2005)
`
`Ex. 1028-0390
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`21673225
`
`14202119
`
`International Application Number:
`
`Confirmation Number:
`
`4315
`
`Title of Invention:
`
`CONJUGATION PROCESS OF BACTERIAL POLYSACCHARIDES TO CARRIER
`PROTEINS
`
`First Named Inventor/Applicant Name:
`
`Ralph Leon BIEMANS
`
`Customer Number:
`
`23347
`
`Filer:
`
`Alice P. Bradney/Johnie Jones
`
`Filer Authorized By:
`
`Alice P. Bradney
`
`Attorney Docket Number:
`
`VB64154Cl US
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`04-MAR-2015
`
`10-MAR-2014
`
`14:48:34
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
`
`Document
`Number
`
`Warnings:
`
`Information:
`
`Document Description
`
`File Name
`
`File Size(Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`Transmittal Letter
`
`VB64154C1_US_1DS_ Transmitt
`al_Letter_ 4_Mar_2015.pdf i - - - - - - - - - - ;
`024a0c86296cab 1 d7 e595c50a 1 07519c27a
`9d40d
`
`91075
`
`no
`
`2
`
`Ex. 1028-0391
`
`

`

`2
`
`Information Disclosure Statement (IDS)
`Form (SB08)
`
`VB64154C1_US_IDS_SB08a_4_
`Mar_2015.pdf
`
`611746
`
`ece 716c646eca8eede6c204f321 d02aa784(
`bfb2
`
`no
`
`4
`
`Warnings:
`
`Information:
`
`A U.S. Patent Number Citation or a U.S. Publication Number Citation is required in the Information Disclosure Statement (IDS) form for
`autoloading of data into USPTO systems. You may remove the form to add the required data in order to correct the Informational Message if
`you are citing U.S. References. If you chose not to include U.S. References, the image of the form will be processed and be made available
`within the Image File Wrapper (IFW) system. However, no data will be extracted from this form. Any additional data such as Foreign Patent
`Documents or Non Patent Literature will be manually reviewed and keyed into USPTO systems.
`
`3
`
`Foreign Reference
`
`VB64154Cl_US_Reference_WO
`07071707.pdf
`
`4243542
`
`1 b2f577 e9615d3546f1 059b9c9c745988aG
`5211
`
`no
`
`97
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`4946363
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Ex. 1028-0392
`
`

`

`Atty. Docket No. VB64154C1 US
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`Application No.:
`Filing Date:
`
`BIEMANS, ET AL.
`
`Art Unit.:
`
`1645
`
`14/202,119
`
`March 10, 2014
`
`Examiner:
`
`Baskar, Padmavathi
`
`Confirmation No.: 4315
`
`Title: CONJUGATION PROCESS OF BACTERIAL POLYSACCHARIDES TO CARRIER PROTEINS
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`
`Applicants request that the references identified on Form PTO/SB/08a appended hereto be considered
`by the Examiner and officially made of record in accordance with the provisions of 37 CFR 1.97
`
`[X] Copies of any foreign patent and/or non-patent literature references are enclosed.
`
`[ ] Copies of the references were submitted in parent application Serial No. __ . (37 CFR 1.98(d))
`
`[ ] A copy of the International Search Report which issued on International Application No.
`________ is submitted herewith. All of the publications cited in the International
`Search Report are listed on the attached form PTO-SB08a and Applicants understand that
`copies have been supplied to the U.S. Patent Office by the International Bureau.
`
`A.
`
`OR
`
`B.
`
`[X] The Information Disclosure Statement submitted herewith is being filed within three
`months of the filing date of the above application or date of entry into the national stage
`of an international application or before the mailing date of a first Office action on the
`merits, whichever event occurs last. 37 CFR 1.97(b).
`
`[ ] The Information Disclosure Statement submitted herewith is being filed before the
`mailing of a first office action after the filing of a Request For Continued Examination
`under 37 C.F.R. 1.114 (37 C.F.R. 1.97(b)(4)).
`
`[ ] The Information Disclosure Statement transmitted herewith is being filed after three
`months of the filing date of the above application or the date of entry into the national
`stage as set forth in § 1.491 of an international application or after the mailing date of the
`first Office Action on the merits, whichever event occurred last, but before the mailing
`date of either:
`(1)
`a final action under§ 1.113 or
`a notice of allowance under§ 1.311,
`(2)
`whichever occurs first.
`
`[ ] Applicant hereby certifies that each item of information contained in this Information
`Disclosure Statement was cited in a communication from a foreign patent office in a
`counterpart foreign application not more than three months prior to the filing of this
`statement.
`
`[ ] Applicant elects the option to pay the fee set forth in 37 CFR 1.17(p) for submission of
`an Information Disclosure Statement under§ 1.97(c) ($140.00).
`
`Ex. 1028-0393
`
`

`

`Atty. Docket No. VB64154C1 US
`
`C.
`
`[ ] The Information Disclosure Statement transmitted herewith is being filed after a final
`action under§ 1.113, or a notice of allowance under§ 1.311, whichever occurs first, but
`before the payment of the issue fee. Also enclosed is a copy of the International Search
`Report which Issued on International Publication No.
`
`In accordance with the requirements of 37 CFR 1.97(d):
`
`[ ] Applicant hereby certifies that each item of information contained in this Information
`Disclosure Statement was cited in a communication from a foreign patent office in a
`counterpart foreign application not more than three months prior to the filing of this
`statement. [or]
`
`[ ] Applicant hereby certifies that no item of information contained in this Information
`Disclosure Statement was cited in a communication from a foreign patent office in a
`counterpart foreign application, and, to my knowledge after making reasonable inquiry,
`no item of information contained in this Information Disclosure Statement was known to
`any individual designated in § 1.56(c) more than three months prior to the filing of this
`statement; and
`
`[ ] The petition fee set forth in § 1.17(i)(1) ($180.00) is submitted herewith.
`
`[X] Please charge any required fees to Deposit Account No.07-1392.
`[ ] A duplicate copy of this paper is attached.
`
`Respectfully Submitted,
`
`/Alice P. Bradney/
`
`Alice P. Bradney
`Attorney of Record
`Registration No. 51,491
`
`Date: March 4, 2015
`GlaxoSmithKline
`Global Patents
`5 Moore Drive, P.O. Box 13398
`Research Triangle Park, NC 27709-3398
`Telephone: (919) 483-1891
`Facsimile: (919) 483-7977
`
`Ex. 1028-0394
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of
`
`Bl EMANS, et al.
`
`Filing No.
`
`Filing Date
`
`Title
`
`Grp. /A.U.
`
`Examiner
`
`14/202, 119
`
`March 10, 2014
`
`CONJUGATION PROCESS OF BACTERIAL
`
`POLYSACCHARIDES TO CARRIER PROTEINS
`
`1645
`
`Baskar, Padmavathi
`
`Confirmation No.
`
`4315
`
`Docket No.
`
`VB64154C1 US
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`RESPONSE
`
`Applicants respectfully request consideration of this response submitted in reply
`
`to the Office Action with Notification Date of February 20, 2015. A two-month period was
`
`set for the response. Applicants believe this Response is timely filed. However, the
`
`Commissioner is hereby authorized in this, concurrent, and future replies, to charge any
`
`fees or credit any overpayment and any necessary extension of time fees, to deposit
`
`Account No. 07-1392.
`
`Remarks begin on page two (2) of this paper.
`
`Ex. 1028-0395
`
`

`

`Application No. 14/202, 119
`
`Attorney Docket No. VB64154C1 US
`
`Claims 1-13 are pending in the application.
`
`REMARKS
`
`A requirement for restriction has been made under 35 U.S.C. 121 among the
`
`inventions of groups:
`
`I.
`
`Claims 1-10, drawn to a process for conjugating a bacterial saccharide
`
`and reducing the sizing effect on bacterial saccharide.
`
`II.
`
`Claims 11-12, drawn to a conjugate and immunogenic composition
`
`comprising conjugate.
`
`Ill.
`
`Claim 13, drawn to a method of inducing an immune response.
`
`Applicants elect Group 1, claims 1-10, with traverse.
`
`The Office Action recites conditions upon which the inventions of Group I and
`
`Group II may be considered distinct. Groups I and II do not fall within the recited criteria.
`
`It is stated that "the process as claimed [in Invention I] can be used to make other
`
`bacterial conjugate polysaccharides such as Neisseria." (page 2, Item 4, Office Action,
`
`notification date 20 Feb 2015). However, claim 1 recites that the bacterial saccharide is
`
`S. pneumoniae capsular saccharide 6B. Claim 11 claims a conjugate obtained by the
`
`process of claim 1. The process of claim 1 is used to make the conjugate of claims 11
`
`and 12. Examination of claims 1-12 is respectfully requested.
`
`Applicants expressly reserve the right to prosecute the subject matter in the non(cid:173)
`
`elected claims, originally filed claims, or any other claims supported by the specification
`
`in one or more continuing applications.
`
`Applicants respectfully submit that the present application is in condition for
`
`examination and respectfully request consideration thereof.
`
`CONCLUSION
`
`Should any outstanding issues remain, the Examiner is encouraged to contact
`
`Applicants' undersigned representative.
`
`2
`
`Ex. 1028-0396
`
`

`

`Application No. 14/202, 119
`
`Attorney Docket No. VB64154C1 US
`
`Date: April 20, 2015
`
`GlaxoSmithKline Inc.
`Global Patents
`Five Moore Drive, P.O. Box 13398
`Research Triangle Park, NC 27709
`Tel. (919) 483-1891
`Fax: (919) 483-7977
`
`Respectfully submitted:
`
`/Alice P. Bradney/
`
`Alice P. Bradney
`Attorney for Applicants
`Reg. No. 51,491
`
`3
`
`Ex. 1028-0397
`
`

`

`Atty. Docket No. VB64154C1 US
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`Application No.:
`Filing Date:
`
`BIEMANS, ET AL.
`
`Art Unit.:
`
`1645
`
`14/202,119
`
`March 10, 2014
`
`Examiner:
`
`Baskar, Padmavathi
`
`Confirmation No.: 4315
`
`Title: CONJUGATION PROCESS OF BACTERIAL POLYSACCHARIDES TO CARRIER PROTEINS
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`
`Applicants request that the references identified on Form PTO/SB/08a appended hereto be considered
`by the Examiner and officially made of record in accordance with the provisions of 37 CFR 1.97
`
`[X] Copies of any foreign patent and/or non-patent literature references are enclosed.
`
`[ ] Copies of the references were submitted in parent application Serial No. __ . (37 CFR 1.98(d))
`
`[ ] A copy of the International Search Report which issued on International Application No.
`________ is submitted herewith. All of the publications cited in the International
`Search Report are listed on the attached form PTO-SB08a and Applicants understand that
`copies have been supplied to the U.S. Patent Office by the International Bureau.
`
`A.
`
`OR
`
`B.
`
`[X] The Information Disclosure Statement submitted herewith is being filed within three
`months of the filing date of the above application or date of entry into the national stage
`of an international application or before the mailing date of a first Office action on the
`merits, whichever event occurs last. 37 CFR 1.97(b).
`
`[ ] The Information Disclosure Statement submitted herewith is being filed before the
`mailing of a first office action after the filing of a Request For Continued Examination
`under 37 C.F.R. 1.114 (37 C.F.R. 1.97(b)(4)).
`
`[ ] The Information Disclosure Statement transmitted herewith is being filed after three
`months of the filing date of the above application or the date of entry into the national
`stage as set forth in § 1.491 of an international application or after the mailing date of the
`first Office Action on the merits, whichever event occurred last, but before the mailing
`date of either:
`(1)
`a final action under§ 1.113 or
`a notice of allowance under§ 1.311,
`(2)
`whichever occurs first.
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`[ ] Applicant hereby certifies that each item of information contained in this Information
`Disclosure Statement was cited in a communication from a foreign patent office in a
`counterpart foreign application not more than three months prior to the filing of this
`statement.
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`[ ] Applicant elects the option to pay the fee set forth in 37 CFR 1.17(p) for submission of
`an Information Disclosure Statement under§ 1.97(c) ($140.00).
`
`Ex. 1028-0398
`
`

`

`Atty. Docket No. VB64154C1 US
`
`C.
`
`[ ] The Information Disclosure Statement transmitted herewith is being filed after a final
`action under§ 1.113, or a notice of allowance under§ 1.311, whichever occurs first, but
`before the payment of the issue fee. Also enclosed is a copy of the International Search
`Report which Issued on International Publication No.
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`In accordance with the requirements of 37 CFR 1.97(d):
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`[ ] Applicant hereby certifies that each item of information contained in this Information
`Disclosure Statement was cited in a communication from a foreign patent office in a
`counterpart foreign application not more than three months prior to the filing of this
`statement. [or]
`
`[ ] Applicant hereby certifies that no item of information contained in this Information
`Disclosure Statement was cited in a communication from a foreign patent office in a
`counterpart foreign application, and, to my knowledge after making reasonable inquiry,
`no item of information contained in this Information Disclosure Statement was known to
`any individual designated in § 1.56(c) more than three months prior to the filing of this
`statement; and
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`[ ] The petition fee set forth in § 1.17(i)(1) ($180.00) is submitted herewith.
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`[X] Please charge any required fees to Deposit Account No.07-1392.
`[ ] A duplicate copy of this paper is attached.
`
`Respectfully Submitted,
`
`/Alice P. Bradney/
`
`Alice P. Bradney
`Attorney of Record
`Registration No. 51,491
`
`Date: April 20, 2015
`GlaxoSmithKline
`Global Patents
`5 Moore Drive, P.O. Box 13398
`Research Triangle Park, NC 27709-3398
`Telephone: (919) 483-1891
`Facsimile: (919) 483-7977
`
`Ex. 1028-0399
`
`

`

`PTOISB108a (01-10)
`Doc code: IDS
`Approved for use through 07/31/2012. 0MB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`14202119
`
`Filing Date
`
`First Named Inventor
`
`2014-03-10
`I BIEMANS, Ralph Leon
`
`Art Unit
`
`Examiner Name
`
`1645
`I Baskar, Padmavathi
`
`Attorney Docket Number
`
`VB64154C1 US
`
`Examiner Cite
`Initial*
`No
`
`Patent Number
`
`Kind
`Code1 Issue Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`U.S.PATENTS
`
`Remove
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`1
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`If you wish to add additional U.S. Patent citation information please click the Add button.
`
`U.S.PATENT APPLICATION PUBLICATIONS
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`Add
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`Remove
`
`Examiner
`Initial*
`
`Cite No
`
`Publication
`Number
`
`Kind Publication
`Code1 Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`1
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`FOREIGN PATENT DOCUMENTS
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`Examiner Cite Foreign Document
`Initial*
`No Number3
`
`Country
`Code2 i
`
`Kind Publication
`Code4 Date
`
`Name of Patentee or
`Applicant of cited
`Document
`
`Pages,Columns,Lines
`where Relevant
`Passages or Relevant
`Figures Appear
`
`T5
`
`1
`
`87/06838
`
`WO
`
`1987-11-19
`
`ANDERSON and EBY
`
`2
`
`99/42130
`
`WO
`
`1999-08-26
`
`CHONG, ET AL.
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`
`NON-PATENT LITERATURE DOCUMENTS
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`Add
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`Remove
`
`D
`
`D
`
`EFSWeb2.1.17
`
`Ex. 1028-0400
`
`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`14202119
`
`Filing Date
`
`First Named Inventor
`
`2014-03-10
`I BIEMANS, Ralph Leon
`
`Art Unit
`
`Examiner Name
`
`1645
`I Baskar, Padmavathi
`
`Attorney Docket Number
`
`VB64154C1 US
`
`Examiner Cite
`Initials* No
`
`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, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
`
`T5
`
`1
`
`D
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
`
`EXAMINER SIGNATURE
`
`Examiner Signature I
`
`I
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`I Date Considered
`
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO
`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here i
`English language translation is attached.
`
`EFSWeb2.1.17
`
`Ex. 1028-0401
`
`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`14202119
`
`Filing Date
`
`First Named Inventor
`
`2014-03-10
`I BIEMANS, Ralph Leon
`
`Art Unit
`
`Examiner Name
`
`1645
`I Baskar, Padmavathi
`
`Attorney Docket Number
`
`VB64154C1 US
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`CERTIFICATION STATEMENT
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`D from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1 ).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`D any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`D See attached certification statement.
`D The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`~ A certification statement is not submitted herewith.
`
`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`
`Name/Print
`
`/Alice P. Bradney/
`
`Alice P. Bradney
`
`Date (YYYY-MM-DD)
`
`2015-04-20
`
`Registration Number
`
`51,491
`
`This collection of information is required by 37 CFR 1.97 and 1.98. 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
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`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`EFSWeb2.1.17
`
`Ex. 1028-0402
`
`

`

`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
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`The information provided by you in this form will be subject to the following routine uses:
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`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
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