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`Sun-Amneal-lPR2016-01104- Ex. 1005-Part 2, p. 1 of 219
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`

`
`NoticeOf
`
`Application No.
`09/788,173
`Examine,
`
`App|icant(s)
`
`Robl
`
`Art Unit
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`I Iiiiilililliiiilliiiii
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`--The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
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`1. IX} This communication is responsive to 8/37/01
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`2. [XI The allowed c|aim(s) is/are 1-24
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`3. U The drawings filed on
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`4. Cl Acknowledgement is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d).
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`Attachmentis)
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`1 D Notice of References Cited (PTO-892)
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`2 D Notice of Informal Patent Application (PTO-152)
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`3 Ci Notice of Draftsperson's Patent Drawing Review (PTO—948)
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`4 D Interview Summary (PTO-413), Paper No.
`
`.
`
`5 [Xi
`
`Information Disclosure Statementls) (PTO-1449), Paper No(s).
`
`2
`
`6 Ci Examiner's Amendment/Comment
`
`7 [:1 Examiner's Comment Regarding Requirementfor Deposit of Biological
`
`Material
`9D Other
`
`8 Ci Examiner's Statement of Reasons?r Allo
`_///
`' ERST
`R0}
`Pgivm YEXAM ER
`ART UNIT 162
`
`/
`
`U. S. Patent and Trademark Office
`
`PTO-37 (Rev. 01-01)
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`Notice of Allowability
`Part of Paper No. 5
`0306
`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 2 of 219 0305
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`
`

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`,
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`'
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`I-ORM PTO-1449 ,_
`-NT OF COMMERCE
`u.s. DEPAR,
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`PATENT AND TRADEMARK OFFICE
`INFORMATION DISCLOSURE CITATION
`-
`1 eets ifnecessary)
`‘
`'
`
`.
`
`Sheet1 of2
`
`ATTY. DOC __,..-NO.
`LA0050 NP
`
`No-
`
`APPLIDANT
`ROBL ET AL.
`FILING DATE
`FEBRUARY 16. 2001
`
`Group
`
`
`
`U.S. PATENT DOCUMENTS
`
`Bachovchin et al “Z
`V
`Jenkins et al
`Villhauer, E.B.
`Villhauer, E.G.
`
`I1
`
`
`
`DOCUMENT NUMBER
`I M. 5,462,928
`- 5,939,560
`- 6,011,155
`H 6,110,949
`ITIE
`
`DATE
`
`10/31/95
`
`8/17/99
`
`1/4/00
`
`8/29/00
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`DOCUMENT NUMBER
`
`DATE
`
`WO 97/40832
`
`1 1/6/01
`
`PCT
`
`WO 99/38501
`
`8/5/99
`
`- PCT
`
`WO 99/67279
`
`12/29/99
`
`PCT
`
`WO 00/10549
`
`WO 00/53171
`
`WO 00/56296
`
`AF
`
`G H I J K
`
`3/2/00
`
`9/14/00
`
`9/28/00
`9/28/00
`
`PCT
`
`PCT
`
`PCT
`PCT
`
`1 1/23/00
`
`PCT
`
`1 1/8/00
`
`6/15/00
`
`PCT
`
`AL WO 00/56297
`
`AM WO O0/69868
`
`AN
`
`EP 1050540A2
`
`AO WO 034241A1
`
`'0
`
`FILING DATE
`
`
`
`
`
`\
`"RAIL-Mm
`
`SUBCLASS
`
`{:1
`
`CLASS
`
`K“HI-
`
`-----
`
`
`
`OTHER DOCUMENTS (Including Author, Title, Date, Pertinent pages. Etc.)
`Lin, J. et al, Proc. Natl. Acad. Sci, USA, Vol. 95, pp. 14020-14024, Nov. 1998
`
`Augustyns, KJL et al, Eur. J. Med. Chem. 32, 301-309, (1997)
`
`/
`/
`
`11
`
`7‘
`
`I
`
`AQ
`
`AR
`
`ASI Hughes, T.E. etal, Biochemistry,'28, 11597-11603, 1999
`E""““'“ER /1 _ °“"“’°”s'°E"E
`
`‘EXAMINER;
`conformance .
`
`.'
`
`itial of e e__rence considered, whether or not citation is in confonnan 3' “ ' 609: Draw a line through citation if not in
`I
`oi nsidred. Include a copy of this form with the next communicatio to plicant.
`
`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 3 of 219 0307
`0307
`(cid:54)(cid:88)(cid:81)(cid:16)(cid:36)(cid:80)(cid:81)(cid:72)(cid:68)(cid:79)(cid:16)(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:20)(cid:25)(cid:16)(cid:19)(cid:20)(cid:20)(cid:19)(cid:23)(cid:16)(cid:3)(cid:40)(cid:91)(cid:17)(cid:3)(cid:20)(cid:19)(cid:19)(cid:24)(cid:16)(cid:51)(cid:68)(cid:85)(cid:87)(cid:3)(cid:21)(cid:15)(cid:3)(cid:83)(cid:17)(cid:3)(cid:22)(cid:3)(cid:82)(cid:73)(cid:3)(cid:21)(cid:20)(cid:28)
`
`/
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`I
`I
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`/
`
`

`
`Best Available Copy
`—
`' -~
`FORM PTO-1449
`U.S. DEPAR1
`T OF COMMERCE
`(REV. 7-85)
`PATENT AND TRADEMARK OFFICE
`INFORMATION DISCLOSURE CITATION
`(Use several
`-
`-
`-
`if necessary)
`O \ P 5
`
`
`
`Sheet 2 of 2
`
`A
`ATTY. DOCIIJ.
`LA0050 NP
`g;,;’§'sfi/g|0N N0-
`APPL|E:AN‘r
`ROBL ET AL.
`FILING DATE
`FEBRUARY 16, 2001
`
`Group
`
`\
`
`\\f“‘-\_\
`—S~§‘~~.__‘p
`
`..‘_~
`
`1’:
`
`>C
`
`W
`
`W U3
`
`WO
`
`Yamada, M. et al, Bioorganic & Medicinal Chemistry Letters 8, 1537-1540 (1998)
`
`Tanaka, S. et al, lmmunopharmacology 40, 21-26 (1998)
`
`Li, J. etal, Archives of Biochemistry and Biophysics, Vol. 323, No. 1, pp. 148-154, Oct. 20, 1995
`
`Ashworth, D.M. et al, Bioorganic & Medicinal Chemistry Letter, Vol. 6, No. 22, pp. 2745-2748, 1996
`
`Yamada, M. et al, Bioorganic & Medicinal Chemistry Letter 8, 1537-1540 (1998)
`
`Ashworth, D.M. et al, Bioorganic & Medicinal Chemistry Letter, Vol. 6, No. 10, pp. 1163-1166, 1996
`
`Lambeir, A.-M., et al, Biochimica et Biophysica Acts, 1290, pp. 76-82 (1996)
`
`Yoshimoto, T. et al, Agric. Biol. Chem., 55(4), pp. 1135-1136, 1991
`
`Belyaev, A. et al, J. Med. Chem., 42, 1041-1052, 1999
`
`Stockel, A. et al, Peptides: Chemistry, Structure and Biology, pp. 709-710, 1996
`
`Asai, Y. et al, The Journal of Antibiotics, Vol. 50, No. 8, pp. 653-657, Aug. 1997
`
`Demuth, H.-U. et al, FEBS LETTERS, Vol. 320, No. 1, pp. 23-27, March 1993
`
`Ohnuki, T. et al, Drugs of the Future, 24(6): 665-670, 1999
`
`Demuth, H-U. et al, Diabetes, 2000, Vol.49, suppl. 1, A102
`
`Rotherberg, P. et al, Diabetes, 2000, Vol. 49, Suppl. 1, A39
`
`IIIU!H"
`
`7
`
`0308
`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 4 of 219 0308
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`
`

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`CASE LA0050 NP
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`CERTIFICATE OF MAILING
`I hereby certify that this paper (along with any paper referred to as being attached or enclosed) is being deposited with the United
`States Postal Service on the date shown below with suff ient postag
`fir
`class mail in an envelope addressed to the: Assistant
`
`Commissioner for Patents, Washington, D.C. 20231.
`
`
`
`
`
`Burton Rodney
`Type or print name
`
`
`
`
`
`IN RE APPLICATION OF
`
`Art Unit: 1626
`
`ROBL ET AL.
`
`Examiner: R. Gerstl
`
`APPLICATION NO: 09/788,173
`
`Batch No.1 N53
`
`FILED: FEBRUARY 16, 2001
`
`FOR: CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF
`DIPEPTIDYL PEPTIDASE IV AND METHOD
`
`Assistant Commissioner for Patents
`
`Washington, D.C. 20231
`
`PETITION PURSUANT TO 37 CFR §1.97gd}
`
`Sir:
`
`Consideration of the Information Disclosure Statement submitted concurrently herewith is requested.
`
`Please charge Deposit Account No. 19-3880 in the name of Bristol-Myers Squibb Company in the amount of
`
`$180 for payment of the fee for filing this petition.
`
`An additional copy of this paper is here enclosed. The Commissioner is hereby authorized to charge
`
`any additional fees which may be required, or credit any overpayment, to Account No. 19-3880 in the name of
`
`Bristol-Myers Squibb Company.
`
`Respectfully submitted.
`
`
`
`urton Rodney
`Attorney for Applicants
`Reg. No. 22,076
`
`
`
`Bristol-Myers Squibb Company
`Patent Department
`P.O. Box 4000
`Princeton, NJ 08543-4000
`(609)2 2-4336 \
`Date:
`/J 5 )‘)oo(
`
`_
`
`\
`0309
`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 5 of 219 03094
`(cid:54)(cid:88)(cid:81)(cid:16)(cid:36)(cid:80)(cid:81)(cid:72)(cid:68)(cid:79)(cid:16)(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:20)(cid:25)(cid:16)(cid:19)(cid:20)(cid:20)(cid:19)(cid:23)(cid:16)(cid:3)(cid:40)(cid:91)(cid:17)(cid:3)(cid:20)(cid:19)(cid:19)(cid:24)(cid:16)(cid:51)(cid:68)(cid:85)(cid:87)(cid:3)(cid:21)(cid:15)(cid:3)(cid:83)(cid:17)(cid:3)(cid:24)(cid:3)(cid:82)(cid:73)(cid:3)(cid:21)(cid:20)(cid:28)
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`BestAvailable Copy
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`I
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`_ 5
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`CASE LAOO50 NP
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`CERTIFICATE OF MAILING
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`ljrereby certify that this paper (along with any paper referred to as being attached -or enclosed) is being deposited with the United
`,States Postal Service on the date shown below with suffic' nt pos
`e as first class mail in an envelope addressed to the: Assistant
`
`
`
`
`
`N
`
`Date
`
`6
`
`
`
`Commissionerfor Patents, Washington, D.C. 20231.
` Burton Rodney
`
`Type or print name
`
`
`
`RE APPLICATION OF
`
`Art Unit: 1626
`
`ROBL ET AL.
`
`Examiner: R. Gerstl
`
`APPLICATION‘ NO: 09/788,173
`
`Batch No.: N53
`
`FILED: FEBRUARY 16, 2001
`
`FOR: CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF
`DIPEPTIDYL PEPTIDASE IV AND METHOD
`
`Assistant Commissioner for Patents
`
`Washington, D.C. 20231
`
`SUPPLEMENTAL INFORMATION DISCLOSURE STATEMENT
`
`Sir:
`
`In accordance with 37 C.F.R. §1.56, applicants wish to call the Examiner’s attention to the
`
`references cited on the attached form(s) PTO-1449.
`
`These references were cited in a search report in a corresponding PCT International
`
`application dated October 23, 2001 that is within 3 months of the filing of this information disclosure
`
`statement. Copies of these references and the search report are enclosed‘ herewith.
`I“
`\
`A petition pursuant\to 37 C.F.R. §1.97(d) is enclosed herewith.
`
`The Examiner is requested to consider the foregoing information in relation to this
`
`application and indicate that each reference was considered by returning a copy of the initialed PTO
`
`1449 form(s).
`
`I2/21/E001 CCIII-IIJ1
`
`00000059 193880
`
`09786173
`
`01 FC':1'c36
`
`180.00 CH
`
`0310
`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 6 of 219 0310
`(cid:54)(cid:88)(cid:81)(cid:16)(cid:36)(cid:80)(cid:81)(cid:72)(cid:68)(cid:79)(cid:16)(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:20)(cid:25)(cid:16)(cid:19)(cid:20)(cid:20)(cid:19)(cid:23)(cid:16)(cid:3)(cid:40)(cid:91)(cid:17)(cid:3)(cid:20)(cid:19)(cid:19)(cid:24)(cid:16)(cid:51)(cid:68)(cid:85)(cid:87)(cid:3)(cid:21)(cid:15)(cid:3)(cid:83)(cid:17)(cid:3)(cid:25)(cid:3)(cid:82)(cid:73)(cid:3)(cid:21)(cid:20)(cid:28)
`
`

`
`_, _.
`
`,
`
`I
`
`Best A‘ab|e Copy
`
`_
`~.
`_
`.SE LA0050 NP
`
`Certificate under 37 C.F.R.
`
`1.97 e 1
`
`I, the undersigned attorney, hereby certify 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.
`
`Respectfully submitted,
`
`Burton Rodney
`Attorney for Applicants
`Reg. No. 22,076
`
`Bristol-Myers Squibb Company
`Patent Department
`P.O. Box 4000
`Princeton, NJ 08543-4000
`(609) 252-4336
`
`Date: /\/\\f' 3) ywq
`
`\
`0311
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`FORM PTO-1449
`U.S. DEPARTMI:.. OF COMMERCE
`(REV. 7-85)
`PATENT AND TRADEMARK OFFICE
`INFORMATION DISCLOSURE CITATION
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`ATTY. DOCKEQ
`LA0050 NP
`A
`355;-;°1’g'°N N0-
`APPLICANT
`ROBL ET AL.
`FILING DATE
`FEBRUARY 16, 2001
`
`- “E9 2 0 zom “)in
`
`‘I.
`R
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`4» J “V U.S. PATENT DOCUMENTS
`DATE
`DOCUMENT NUMBER
`
`4,254,057
`
`4,379,785
`
`5,998,463
`
`3/3/81
`
`4/12/83
`
`Day et al
`
`Weyer et al
`
`,
`
`12/7/99
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`Hulin et al
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`I-IMO-‘El E1
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`FAZZEI D
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`
`‘I Sagnard, I. etal, Tetrahedron Letters, Vol. 36, No. 18, pp. 3149-3152, 1995.
`Tverezovsky, V.V. etal, Tetrahedron, Vol. 53, No. 43, pp. 14773-14792, 1997.
`Q Hanessian, S. et al, Bioorganic & Medicinal Chem. Letters, Vol. 8, No. 16, pp. 2123-2128, Aug. 18,
`_
`_
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`A A
`EXAM ER
`DATE CONSIDRED
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`‘EXAMINER:
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`OTHER DOCUMENTS (Including Author, TitIe, Date, Pertinent pages, Etc.)
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`1998.
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`TENT COOPERATION TREATY ‘
`
`PCT
`
`
`
`From the INTERNATIONAL SEARC ‘
`
`
`
`T0‘
`
`ATION OF TRANSMITTAL OF
`BRISTOL—MYERS SQUIBB C0.
`' RNATIONAL SEARCH REPORT
`OR THE DECLARATION
`Attn. Algieri, Aldo A.
`P.0. Box 4000
`
`Lawrenceville-Princeton R
`
`(PCT Rule 44.1)
`PRINCETON, NJ 08543
`
`
`UNITED STATES OF AMERICI
`
`
`
`
`
`
`
`
`
`‘day/m°"'“’Y9a” 23/10/2001
`
`Date of mailing
`
`
`
`FOR FURTHER ACTION
`See paragraphs 1 and 4 below
`
`International filing date
`International application No.
`I“aY""°"‘"’Y“')
`05/03/2001
`
`
`Applicant's or agents file reference
`
`LA0050
`
`PCT/ US 01/ 07151
`
`Applicant
`
`BRISTOL—MYERS SQUIBB CO .
`
`
`1. [E The applicant is hereby notified that the International Search Report has been established and is transmitted herewith.
`Filing of amendments and statement under Article 19:
`The applicant is entitled. if he so wishes. to amend the claims of the International Application (see Rule 46):
`
`When? The time limit for filing such amendments is normally 2 months from the date of transmittal of the
`International Search Report; however, for more details. see the notes on the accompanying sheet.
`
`Where? Directly to the
`
`
`International Bureau of WIPO
`34, chemin des Colombettes
`1211 Geneva 20, Switzerland
`Fascimile No.: (41-22) 740.14.35
`
`
`
`For more detailed instructions, see the notes on the accompanying sheet.
`
`
`3. D with regard to the protest against payment of (an) additional fee(s) under Rule 40.2, the applicant is notified that:
`
`D the protest together with the decision thereon has been transmitted to the International Bureau together with the
`applicant’s request to forward the texts of both the protest and the decision thereon to the designated Offices.
`
`|:] no decision has been made yet on the protest; the applicant will be notified as soon as a decision is made.
`
`
`4. Further action(s):
`
`
`
`
`
`
`
`Fax: (+31 -70) 340-3016
`
`
`
`The applicant is reminded of the following:
`
`Shortly after 18 months from the priority date, the international application will be published by the International Bureau.
`If the applicant wishes to avoid or postpone publication, a notice of withdrawal of the international application, or of the
`priority claim, must reach the International Bureau as provided in Rules 90bis.1 and 90bis.3, respectively, before the
`completion of the technical preparations for international publication.
`
`Within 19 months from the priority date, a demand for international prellmlnary examination must be filed if the applicant
`wishes to postpone the entry into the national phase until 30 months from the priority date (in some Offices even later).
`
`within 20 months from the priority date, the applicant must perform the prescribed acts for entry into the national phase
`before all designated Offices which have not been elected in the demand or in a later election within 19 months from the
`priority date or could not be elected because they are not bound by Chapter II.
`
`Name and mailing address of the International Searching Authority
`-: European Patent Office, P.B. 5818 Patentlaan 2
`NL—2280 HV Rijswijk
`0 Tel. (+31-70) 340-2040, Tx. 31651 epo nl,
`
`Authorized officer
`
`Chantal Meyer
`
`Form PCTIISA/220 (July 1998)
`
`0313
`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 9 of 219 0313
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`
`2. D The applicant is hereby notified that no International Search Report will be established and that the declaration under
`Article 17(2)(a) to that effect is transmitted herewith.
`
`

`
`
`
`
`
`
`These Notes are intended to give the basic instructions concerning the filing of amendments under article 19. The
`Notes are based on the requirements of the Patent Cooperation Treaty, the Regulations and the Adninistrative Instructions
`under that Treaty. In case of discrepancy between these Notes and those requirements, the latter are applicable. For more
`detailed information, see also the PCT Applicant's Guide, a publication ol WIPO.
`
`
`
`
`
`In these Notes, ‘Article’, “Rule”, and 'Section' refer to the provisions of the PCT, the PCT Regulations and the PCT
`Administrative lnstmdions respectively.
`
`
`
`INSTRUCTIONS CONCERNING AMENDMENTS UNDER ARTICLE 19
`
`
`
`The applicant has, after having received the international search report, one opportunity to amend the claims of the
`international application. It should however be emphasized that, since all parts of the international application (claims,
`description and dawings) may be amended during the international preliminary examination procedure, there is usually
`no need to file amendments of the claims under Article 19 except where, e.g. the applicant wants the latter to be publhed
`tor the purposes ol provisional protection or has another reason tor amending the claims betore international pbulication.
`Furthermore, it should be emphasized that provisional protection is available in some States only.
`
`
`What parts of the International application may be amended?
`Under Article 19, only the claims may be amended.
`
`
`During the international phase, the claims may also be amended (or further amended) under Article 34 before
`the lntemational Preliminary Examining
`The description and drawings may only be amended under
`Article 34 before the lntemational Examining Authority.
`—
`
`
`
`
`
`Upon entry into the national phase, all parts oi the international application may be amended under Article 28
`or, where applicable, Article 41.
`
`NOTES TO FORM PCTllSAI22O
`
`
`
`
`
`
`Within 2 months trorn the date ol transmittal ot the international search report or 16 months lrom the priority
`date, whichever time limit expires later. It should be noted, however, that the amendments will be considered
`as having been received on time if they are received by the lntemational Bureau after the expiration ol the
`applicable time limit but before the completion of the technical preparations for international publication
`(Rule 46.1).
`
`
`
`
`
`Where not to tile the amendments?
`
`
`The amendments may only be filed with the International Bureau and not with the receiving Office or the
`International Searching Authority (Rule 46.2).
`
`
`
`Where a demand for international preliminary examination has been/is filed, see below.
`
`
`
`
`
`
` Either by cancelling one or more entire claims, by adding one or more new claims or by amendng the text ot
`one or more of the claims 3 filed.
`
`
`
`A replacement sheet must be submitted for each sheet of the claims which, on account of an amendment or
`amencinents, ditters trorn the sheet originally filed.
`
`
`
`All the claims appearing on a replacement sheet must be numbered in Arabic numerals. Where a claim is
`cancelled, no renumbering ol the other claims is required. In all cases where claims are renumbered, they must
`be renumbered consecutively (Administrative Instructions, Section 205(b)).
`
`The amendments must be made In the language In which thelnternatlonal application is to be published.
`
`_
`
`What documents must/may accompany the amendments?
`
`Letter (sedlon 205(b)):
`
`The amendments must be submitted with a letter.
`
` The letter will not be published with the international application and the amended claims. It should not be
`conlused with the ‘Statement under Article 19(1)‘ (see below, under '&atement under Article 19(1)‘).
`
`The letter must be In English or French, at the choice at the applicant. However, It the language of the
`international application Is Engllsh, the letter must be In English; H the language of the international qipllcatlon
`is French, the letter must be In French.
`
`Notes to Fonn PCTllSAl22O (first sheet) (January 1994)
`
`l.‘tllDI\I‘~l‘Il'\» -vercA'nn\|r\CaIDa I ~
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`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 10 of 219 0314
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`
`

`
`NOTES TO FORM PCTl|SAl220 (continued)
`
`‘the letter must "indicate the differences between the claims as filed and the claims as amended. It must. in
`particular, indcate. in connection with each claim appearing in the international application 01 being understood
`that identical indications concerning several claims may be grouped),whether
`(i)
`the claim is unchanged;
`
`(11)
`
`(iii)
`
`(iv)
`
`(v)
`
`the claim is cancelled;
`
`the claim is new;
`
`the claim replaces one or more claims as filed;
`
`the claim is the result of the division of a claim as filed.
`
`The lollowlng examples Illustrate the manner In which amendments must be explained In the
`accompanylng later:
`
`1. ' [Where originally there were 48 claims and alter amendmentol some claims there are 51]:
`‘Claims 1 to 29, 31, 32. 34, 35, 37 to 48 replaced by amended claims bearing the same numbers:
`claims 30. 33 and 36 unchanged; new claims 49 to 51 added.‘
`
`[Where originally there were 15 claims and alter amencknent of all claims there are 11]:
`‘Claims 1 to 15 replaced by amended claims 1 to 11 ."
`
`[Where originally there were 14 claims and the amendments consist in cancelling some claims and in addng
`new claims]:
`‘Claims 1 to 6 and 14 unchanged; claims 7 to 13 cancelled; new claims 15, 16 and 17 added.‘ or
`‘Claims 7 to 13 cancelled; new claims 15, 16 and 17 added; all other claims unchanged.‘
`
`[Where various kinds ol amendments are made]:
`‘Claims 1-10 unchanged; claims 11 to 13, 18 and 19 cancelled; claims 14. 15 and 16 replaced by amended
`claim 14; claim 17 subdivided into amended claims 15, 16 and 17; new claims 20 and 21 added.‘
`
`'StdemoI‘It under article 19(1)‘ (Flute 46.4)
`
`The amendments may be accompanied by a statement explaining the amendments and indcating any impact
`that such amendments might have on the description and the ckawings (which cannot be amended under
`Article 19(1 )).
`
`The statement will be published with the international application and the amended claims.
`
`It must be In the language In which the lnternatlonal apppllcatlon Is to be published.
`It must be briel, not exceeding 500 words it in English or it translated into English.
`
`It should not be confused with and does not replace the letter indicating the cilferences between the claims
`as filed and as amended. It must be filed on a separate sheet and must be identified as such by a heading,
`preferably by using the words ‘Statement under Article 19(1).‘
`It may not contain any dparaging comments on the international search report or the relevance of citations
`contained in that report. Reference to citations, relevant to a given claim. contained in the international search
`report may be made only in connection with an amendment 01 that claim.
`
`consequence 11 a dematd tor International prellmlnary examlnatlon has dready been tlled
`ll, at the time of filing any amendments under Article 1 9, a demand for international preliminaiy examination
`has already been submitted, the applicant must preferably, at the same time cl filing the amendments with the
`lntemational Bureau, also file a copy of such amendments with the lntemational Preliminary Examining
`Authority (see Rule 62.2(a), first sentence).
`
`consequence wlth regard to translation at the International application for entry Into the national phase
`
`The applicant's attention is drawn to the fact that. where upon entry into the national phase, a translation of the
`claims as amended under Article 19 may have to be lurnished to the designatedlelected Offices, instead cl, or
`in addition to. the translation of the claims as filed.
`
`For further details on the requirements of each designated/elected Office, see Volume ll 01 the PCT Applicant's
`Guide.
`
`Notes to Form PCT/|SN220 (second sheet) (January 1994)
`
`DAIQf\(\f‘Il'\» aVQlClt’YJl\KIf\CKlDA I -
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`Sun-Amneal-|PR2016-01104- Ex. 1005-Part 2, p. 11 of 219 0315
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`
`

`
`I
`
`_
`
`H 9A+em coptpsmrloin TREAT
`
`INTERNATIONAL SEARCH REPCRT
`
`(PCT Article 18 and Rules 43 and 44)
`
`Applicants or agents file reference
`
`LA0050
`International application No.
`
`PCT/US 01/ 07151
`Applicant
`
`R F RTHER see Notification of Transmittal of International Search Report
`U
`(Form PCT/ISA/220) as well as, where applicable, item 5 below.
`F0
`ACTION
`International filing date (day/month/year)
`
`(Earliest) Priority Date (day/month/year)
`
`I
`
`g
`
`05/03/2001
`
`10/03/2000
`
`BRISTOL-MYERS SQUIBB CO .
`
`This International Search Report has been prepared by this International Searching Authority and is transmitted to the applicant
`according to Article 18. A copy is being transmitted to the International Bureau.
`
`sheets.
`5
`This International Search Report consists of a total of
`K]
`It is also accompanied by a copy of each prior art document cited in this report.
`
`1. Basis of the report
`
`a. With regard to the language, the international search was carried out on the basis oi the international application in the
`language in which it was filed, unless otherwise indicated under this item.
`
`D the international search was carried out on the basis of a translation of the international application furnished to this
`Authority (Rule 23.1 (b)).
`
`with regard to any nucleotide andlor amino acid sequence disclosed in the international application, the international search
`was carried out on the basis of the sequence listing :
`contained in the international application in written form.
`
`filed together with the international application in computer readable form.
`
`furnished subsequently to this Authority in written form.
`
`furnished subsequently to this Authority in computer readble form.
`the statement that the subsequently furnished written s