`(Modified)
`
`us. Department ofCommerce Attorney Docket No.
`Patent and Trademark Office
`1 5730,02039U825/203 9E
`
`Application No.
`14/683,415
`
`Sheet L ofi
`
`Helenek er at].
`FilinsDate
`Apr11 10, 2015
`U. S. Patent Documents
`Publication
`Date
`
`Patentee
`
`GrOUP Alt Unit
`1673
`
`Class
`
`Subclass
`
`Filing Date
`If A n s ro o riate
`
`
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Examiner
`Initial
`
`Desig.
`ID
`
`Document
`Number
`
`
`7,754 702
`07/13/10
`Helenek et a1
`01/08/2007
`
`8,431,549
`
`04/03/13
`
`Helenek er a1.
`
`.
`
`05/25/2010
`
`Examiner
`Initial
`
`Foreign Patent Documents or Published Foreign Patent Applications
`'
`.
`Document
`Publication
`Country or Patent
`Translation
`Number
`Date
`Office
`
`None
`
`
`
`Other Documents include Author, Title, Date, and Place of Publication
`Desig.
`
`Examiner
`Initial
`
`Document
`Letter/Written Disclosure of the initial lnforrnation Disclosure Statement for the above -referenced
`
`application filed herewith on January 27, 2 pages.
`Auerbach et a1, "Low-molecular weight iron dextran and iron sucrose have similar comparative
`
`safety profiles in chronic kidney disease," Kidney International 73 2528-530 (2008).
`DanielsonB.G., "Structure. chemistry, and pharmacokinetics of intravenous iron agents," J Am Soc
`Nephrol 15 Suppl 2:S93-S98 (2004).
`Decision of the Technical Board of Appeal, dated March 1, 2006, in connection with European
`Patent No. 0679508, 1'7 pages.
`Fisons Pharmaceuticals, "Iniferon" US drug monograph. 2 pages (1989),
`
`—
`
`
`
`
`Jahn et. al., "A comparative study of the physiochemical properties of iron isomaltoside 1000
`(Monofer), a new intravenous iron preparation and its clinical implications," European J of
`Pharmaceutics and Bio oharmaceutics 78:480-491 (2011).
`Johansson et a1., "Intravenous iron isomaltoside 1000 (lVlonofert’RJ) reduces postoperative anaemia in
`preoperativcly non-anaemic patients undergoing clectivc or subacutc coronary artery bypass graft,
`valve replacement or a combination thereof: a randomized double -blind placebo-controlled clinical
`trial (the PROTECT trial)," Vox Sang 109(3):257-266 (2015).
`Kulnigg et at, "A novel intravenous iron formulation for treatment of anemia in inflammatory
`bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial," Am J
`Gastroenterol 103(5): 1 182-1 192 (2008).
`
`_: MacDougalleta1,"Useofintravenousironsupplementationinchronickidneydisease"IranianJ
`
`Kidney Dis 7(1):9-22 (2013).
`MacDougall I.C., "Strategies for iron supplementation: Oral versus intravenous" Kidney
`
`International 55(69): 861-66 (1999').
`Reinisch et al._, "A randomized, open—label, non-inferiority study of intravenous iron isomaltoside
`1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED)," Am J
`
`Gastroenterol 108(12):1877-88 (2013).
`Reinisch et. al., "A l-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain
`stable hemoglobin levels in inflammatory bowel disease," Scand J Gastroenterol 50(10):l226-l 233
`(2015).
`— Syncr-Mcd, "Summary of Product Characteristics; Fcrinjecl," (2009), 8 pages.
`Office Action, mailed Dec. 15, 2009, in connection with US. Patent Application Serial No,
`11/620,986, 21 pages.
`Response, dated Jan 08, 2010, in connection with U.S, Patent Application Serial No. 11/620,986,
`13 pages.
`
`Examiner Signature
`
`Date Considered
`
`Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in
`EXAMINER:
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`Ex. 3003
`Ex. 3003
`PGR2020-00009
`PGR2020-00009
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH,
`
`/J.S.L/
`
`
`
`Substitute Form PTO-1449
`(Modified)
`
`us. Department ofCommerce Attorney Docket No.
`Patent and Trademark Office
`1 5730.02039U825/203 9E
`
`Application No.
`14/683,415
`
`Sheet L ofi
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`>(AII73
`
`Helenek et at].
`GrOUP Alt Unit
`Filianate
`1673
`Apr11 10, 2015
`Notice of Allowance, mailed April 5, 2010, in connection with US. Patent Application Serial No.
`11/620,986, 12 pages.
`Petition for Inter Partes Review of US. Patent No. 7,754,702, mailed June 24, 2015, in connection
`withUS Patent Application Serial No. 11/620,986, 65 pages.
`Patent Owner Preliminary Response, dated Oct. 12, 2015, in connection with US. Patent
`>,4
`Application Serial No. 11/620,986 (US. Patent No. 7,754,702), 39 pages.
`Decision, entered Jan. 08, 2016, in connection with U. S. Patent Application Serial No. 11/620,986
`(US. Patent No. 7,754,702), 20 pages.
`Order Conduct of the Proceedings, mailed Mar. 11, 2016, in comiection with US. Patent
`><
`Application Serial No. 11/620,986 (US. Patent No. 7,754,702), 6 pages.
`Patent Owner Response, mailed Mar. 29, 2016, in connection with US. Patent Application Serial
`No. 11/620,986 (US. PatentNo. 7,754,702), 47
`.
`Patent Owner Exhibit List as of March 29, 2016. mailed Mar. 29, 2016, in connection with US.
`Patent Application Serial No. 11/620,986 (US. Patent No. 7 ,754,702), 7 pages.
`Motion to Amend, mailed Mar. 29, 2016, in connection with U. S. Patent Application Serial No.
`11/620,986 (US Patent No.
`.,754,702), 48 pages.
`Petitioner's Notice of Objections to Evidence, mailed Apr. 5, 2016, in connection with US. Patent
`Application Serial No. 11/620,986 (US. Patent No. 7,754,702), 5 pages.
`Corrected Patent Owner Exhibit List as of April 25, 2016. mailed Apr. 25. 2016, in connection with
`US. Patent A lication Serial No. 11/620,986 (US. Patent No. 7,754,702),7 a_es.
`Corrected Motion to Amend, mailed Apr. 25, 2016, in connection with US. Patent Application
`Serial No. 11/620,986 (US. Patent No. 7,754,702), 48 pages.
`Petitioner's Reply to Patth Owner Response, dated June, 20, 2016, in connection with U. S. Patent
`A lication Serial No. 11/620,986 US Patent No. 7,754,702
`Petitioner's Opposition to Patent Owner's Motion to Amend, dated June 20, 2016, in connection
`with US. Patent A lication Serial No. 11/620,986 (US. Patent No. 7,754,702), 31 ua,es.
`Objections to Petitioner's Reply and Opposition Evidence, dated Jme 27, 2016, in connection with
`US. Patent A lication Serial No. 11/620,986 (US. PatcntNo. 7.754.702). 5
`a_cs.
`Patent Owner Reply to Opposition to Motion to Amend, dated July 19, 2016. in connection with
`US. Patent A ulication Serial No. 11/620,986 (US. Patent No. 7,754,702), 20
`.
`Patent Owner Motion to Exclude, dated Aug. 09, 2016, in connection with US. Patent Application
`Serial No. 11/620,986 (US. Patent No. 7,754,702 , 19
`.
`Order Conduct of the Proceedings, dated Aug. 19, 2016, in connection with U. S. Patent Application
`Serial No. 11/620,986 (US. Patent No. 7,754,702), 3
`'
`.
`Order Trial Hearing, dated Aug. 22, 2016, in connection with US. Patent Application Serial Nos.
`11/620,986 (US Patent No.
`.,754,702), 5 pages.
`Petitioner's Opposition to Patent Owner's Motion to Exclude, dated Aug. 23, 2016, in connection
`with US. Patent Application Serial No. 11/620,986 (US. Patent No. 7.754.702), 19 pages.
`Patent Owner Reply to Opposition to Motion to Exclude, dated Aug. 30, 2016, in connection with
`US. Patent A lication Serial No. 11/620,986 (US. Patent No. 7,754,702). 9 a_cs.
`Record of Oral Hearing, dated Nov. 03, 2016, in connection with US. Patent Application Serial No.
`WI.“
`11/620,986 (US. Patent No. 7,754,702), 104 pages.
`Final Written Decisiort dated Jan 4, 2017 , in connection with US. Patent Application Serial No.
`11/620,986 US Patent No.
`.,754,702 , 52
`.
`Restriction Requirement, dated March 23, 2012, in connection with US. Patent Application Serial
`No. 12/787,283, 7 pages.
`Response, dated April 19, 2012, to Restriction Requirement, mailed March 23, 2012, in connection
`with US. Patent Application Serial No. 12/787,283, 4 pages.
`Office Action, mailed June 6. 2012, in connection with US. Patent Application Serial No.
`12/787,283, 13 pages.
`Response, dated Dec. 6, 2012, to Office Actiort mailed June 6, 2012. in connection with US. Patent
`A ulication Serial No. 12/787,283, 34 -a_es.
`Date Considered
`
`W O
`
`
`“a
`
`a;2
`
`>><
`
`i
`
`W >
`
`WW
`
`W O
`
`Wm
`
`W.11
`
`W C)
`
`WI
`
`W._t
`
`W r-i
`
`wW
`
`a:Z
`
`WZ
`
`Examiner Signature
`
`Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in
`EXAMINER:
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH,
`
`/J.S.L/
`
`
`
`Substitute Form PTO-1449
`(Modified)
`
`us. Department ofCommerce Attorney Docket No.
`Patent and Trademark Office
`1 5730,02039US25/203 9E
`
`Application No.
`l4/683,415
`
`Sheet
`
`3 ofi
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`m2
`
`[It><
`
`{It
`
`071N
`
`OCl>
`
`onenitric:
`
`OO
`
`Helenek et at].
`GrOUP Alt Unit
`Filianate
`1673
`Apnl 10, 2015
`Applicant-Initiated Interview Summary. mailed Feb. 6, 2013. in connection with US. Patent
`Application Serial No. 12/787,283, 4 pages.
`Notice of Allowance, mailed Feb. 28, 2013, in connection with U. S. Patent Application Serial No.
`12/787,283, 14 pages.
`Petition for Inter Partes Review of US. Patent No. 8,431,549, dated June 24, 2015, in connection
`
`with US. Patent Application Serial No. 12/787,283, 67 pages,
`Patent Owner Preliminary Response, dated Oct. 12, 2015, in connection with U. S. Patent
`Application Serial No. 12/787,283 (US. Patent No. 8431,549), 65 pages.
`Order Conduct of the Proceeding, entered Oct. 14, 2015, in comlection with US. Patent Application
`[It <1
`Serial No. 12/787,283 (US. Patent No. 8,431,549), 4 pages.
`Notice of Response in lieu of Motion. dated Oct, 20. 2015, in connection with U. S. Patent
`A lication Serial No. 12/787,283 US. Patent No.,431_,549 ,4 a es.
`Petitioner's Objection to Patent Owner Response in Lieu of Motion, dated Oct. 30, 2015, in
`connection with US. Patent Application Serial No. 12/787,283 (US. Patent No. 8,431,549), 4
`pages.
`Inter Partes Review Decision, entered Jan, 08, 2016, in connection with US. Patent Application
`Serial No. 12/787,283 (US. Patent No. $431,549), 24 pages.
`Request for Rehearing, dated Jan. 22, 2016, in connection with US. Patent Application Serial No.
`12/787,283 (US. Patent No. 8.431549), 8 pages.
`Patent Owner Objections to Evidence, dated Jan. 27. 2016. in connection with US Patent
`A ulication Serial No. 12/787,283 (US. Patent No. 8,431,549), 4 -_acs.
`Revised Patent Owner Notice of Deposition of Dr. Linhardt, dated Feb. 1‘), 2016, in connection
`0DJ
`withUS Patent Application Serial No. 12/787,283 (US. Patent No. 8,431,549), 3 pages.
`Decision Denying Petitioner's Request for Rehearing, entered Feb. 26, 2016, in connection with
`('3O
`US Patent Application Serial No. 12/787,283 (US. Patent No. 8,431,549), 5 pages.
`Order re Conference Call on March 09, 2016, entered Mar. 1 l, 2016, in connection with US. Patent
`A n lication Serial No. 12/787,283 (US. Patent No. 8,431,549), 6 '
`.
`Patent Owner Exhibit List as of July 19, 2016 in connection with US. Patent Application Serial No.
`12/787283 (US. Patent No. 8,431,549), 7 a_cs.
`Patent Owner Reply to Opposition to Motion to Amend, dated July 19, 2016, in connection with
`US. Patent A ulication Serial No. 12/787,283 (US. Patent No. 8.431,549), 20
`.
`Order Trial Hearing, dated Aug. 22, 2016, in connection with U S. Patent Application Serial No.
`12/787,283 US. Patent No. 8,431,549 5
`.
`Record of Oral Hearing, dated Nov. 03, 2016, in connection with US. Patent Application Serial No.
`12/787,283 (US. Patent No. 8,431,549), 104 pages.
`Inter Partes Review Final Written Decision filed Dec, 28, 2016, in connection with US. Patent
`Application Serial No. 12/787,283 (US. Patent No. 8,431,549), 28 pages.
`Restriction Requirement, mailed Dec, 30. 2013, in connection with US Patent Application Serial
`No. 13/847,254. 7 pages.
`Response, dated Feb. 28. 2014. to Restriction Requirement. mailed Dec, 30, 2013, in connection
`with US Patent A lication Serial No. 13/847254, 4 0 _es.
`Office Action, mailed Apr. 07, 2014, in connection with US. Patent Application Serial No.
`Or‘
`13/847,254, 17 pages.
`Response, dated Jilly 03, 2014, to Office Action, mailed Apr. 07, 2014, in connection with US
`0Z
`Patent Application Serial No. 13/847,254, 18 pages,
`Office Action, mailed Oct. 14, 2014. in connection with US. Patent Application Serial No.
`13/847,254, 14 pages.
`Office Action, mailed Feb. 7, 2014, in connection with US. Patent Application Serial No.
`14/100,717, 15 pages.
`Response, filed June 9. 2014. to Office Action mailed Feb. 7. 2014. in connection with US Patent
`Application Serial No. 14/100,717, 19 pages.
`
`('1II
`
`
`
`
`r)mQQ._'7').
`
`('1Z
`
`l")"U
`
`Examiner Signature
`
`Date Considered
`
`Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in
`EXAMINER:
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.S.L/
`
`
`
`Substitute Form PTO-1449
`(Modified)
`
`us. Department ofCommeroe Attorney Docket No.
`Patent and Trademark Office
`1 5730.02039U825/203 9E
`
`Application No.
`14/683,415
`
`Sheet i ofi
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Helenek et at].
`GrOUP Alt Unit
`FilinsDate
`1673
`Aprrl 10, 2015
`Notice of Allowance, mailed Sept. 22, 2014, in connection with US. Patent Application Serial No.
`14/100,717, 14 pages.
`Petition for Inter Partes Review of U.S. Patent No. 8,895,612, filed June 24, 2015, in connection
`withUS Patent Application Serial No. 14/100,717, 68 pages.
`Patent Owner Preliminary Response, dated Oct, 12, 2015, to Petition for Inter Partes Review, filed
`June 24, 2015, in connection with US. Patent Application Serial No. 14/100,717 (US. Patent No.
`8,895,612), 70 pages.
`Decision Denying Institution of Inter Partcs Review, entered Jan. 8, 2016, in connection with US
`Patent A lication Serial No. 14/100,717 (US, Patent No. 8,895,612), 23
`a_cs,
`Response, dated May 17, 2013, to Office Action issued in connection with Australian Patent
`A nlication No. 2007205167, 28
`,
`Notice of Acceptance, mailed June 04, 2013, in connection with Australian Patent Application No.
`2007205167, 1 nae.
`Examination Report, issued Apr. 13, 2015, in connection with Australian Patent Application No.
`2013206429,4pages
`to Examination Report, issued Apr, 13, 2015, in connection with
`Response, dated Mar. 22, 2016,
`Australian Patent Application No. 2013206429, 36 pages.
`Notice of Acceptance, issued Apr. 14, 2016, in connection with Australian Patent Application No.
`2013206429, 3 pages,
`Examination Report. issued Jan. 11. 2017, in connection with Australian Patent Application No.
`2016205002, 5
`a_es,
`Response, dated July 4, 2013, to Examiner's Report, issued Jan. 4, 2013, in connection with
`U >
`Canadian Patent Application No. 2,635,894, 26 pages.
`Examiner‘s Report, issued Oct, 17, 2013, in connection with Canadian Patent Application No.
`E
`2,635,894, 4 pages,
`Response, dated April 16, 2014, to Examiner’s Report, issued Oct. 17, 2013,
`Canadian Patent A lication No, 2,635,894, 33
`'
`Examiner's Report, issued Oct. 10, 2014. in connection with Canadian Patent Application No.
`2,635.894, 7 a_es.
`Response, dated April 8, 2015, to Examiner's Report, issued Oct. 10, 2014, in connection with
`Canadian Patent A lication No, 2,63 5,894, 30
`,
`Examiner's Report, issued Sept, 29, 2015. in connection with Canadian Patent Application No.
`2,635,894, 8
`.
`Response, dated March 23, 2016, to Examiner's Report, issued Sept. 29, 2015, in connection with
`Canadian Patent Application No. 2,635,894, 19 pages.
`Examiner‘s Report, issued May 16, 2016, in connection with Canadian Patent Application No,
`2,635.894, 8 pages.
`Response, dated Nov. 15. 2016, to Examiner's Report. issued May 16, 2016, in connection with
`Canadian Patent Application No, 2,635,894, 24 pages,
`Examination Report. issued May 10. 201 1, in connection with European Patent Application No,
`0771630956
`.
`
`Ur
`DN
`
`f')O
`
`0pc
`
`I“) m
`
`0._]
`
`0000~<><€<
`
`ON
`
`U('1
`
`Um
`
`U#11
`
`U C)
`
`29%
`
`in connection with
`
`Response, dated Dec. 14, 2012, to Examination Report, dated June 4, 2012, in connection with
`UW
`European Patent Application No. 077163095, 17 pages.
`Response, dated Jan. 15, 2014, to Examination Report, dated July 5, 2013, in connection with
`European Patent Application No. 077163095, 19 pages.
`Third Party Observations, submitted Oct. 31, 2014, and Conununication pursuant to Rule 114(2)
`EPC, dated Nov. 10, 2014, in connection willr European Patent Application No. 077163095 [Third
`party observations, Communication and cited references], 22 pages.
`Summons to Attend Oral Proceedings, dated Feb. 9, 2015, issued in connection with European
`Patent Application No. 077163095, 4 pages,
`D0
`Response, dated Oct. 30, 2015, to Summons to Attend Oral Proceedings, dated Feb. 9, 2015, in
`
`connection with European Patent Application No. 077163095, 98 pages.
`Date Considered
`
`Examiner Signature
`
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`EXAMINER:
`
`Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH,
`
`/J,S.L/
`
`
`
`Substitute Form PTO-1449
`(Modified)
`
`us. Department ofCommerce Attorney Docket No.
`Patent and Trademark Office
`1 573002039U825/203 9E
`
`Application No.
`14/683,415
`
`Sheet i ofi
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Helenek et at].
`GrOUP Alt Unit
`FilinaDate
`1673
`Apr11 10, 2015
`Third Party Observations, submitted Nov, 11, 2015. and Communication maintaining the date/time
`for oral proceedings, dated Nov. 12, 2015, in connection with European Patent Application N 0.
`077163095, 4 pages.
`Response, dated Nov 27, 2015, to Notice Concerning the Oral Proceedings, dated Nov, 19, 2015, in
`connection with European Patent Application No. 077163095, 67 pages.
`Decision to Grant, dated June 23, 2016, issued in connection with European Patent Application No.
`077163095. 2 pages.
`Examination Report, issued April 7, 2014, in connection with European Patent Application No.
`131669889, 4 a_cs.
`Response, dated Oct. 17, 2014, to Examination Report, issued April 7, 2014, in connection with
`Euro uean Patent A ulication No. 131669889, 13
`.
`Third Party Observations. submitted Nov, 03, 2014, in connection with European Patent
`A lication No. 131669889, 2
`'
`.
`Summons to Attend Oral Proceedings, dated Feb. 10, 2015, in connection with European Patent
`Application No. 131669889, 6 pages.
`Response, dated Oct. 30, 2015, to Summons to Attend Oral Proceedings, dated Feb. 10, 2015, in
`connection with European Patent Application N 0. 131669889. 91 pages,
`Third Party Observations, submitted Nov, 11. 2015. and Communication maintaining the date/time
`for oral proceedings, dated Nov. 12, 2015, in connection with European Patent Application No.
`131669889, 4 pages.
`Response, dated Nov, 23, 2015, to Summons to Attend Oral Proceedings, dated Feb. 10, 2015, in
`connection ndth Euro can Patent A ulication No. 131669889, 13
`'
`.
`Commtmication from the Patent Office, issued Nov. 30, 2015, in connection with European Patent
`A lication No. 131669889, 1 ae
`Response, dated Nov, 27 20
`65 aes.
`Intention to Grant, dated Dec. 22, 2015.
`131669889 7
`.
`
`in connection with European Patent Application No.
`
`Upd
`
`U m
`
`U’—1
`
`UG
`
`US
`
`U><j
`
`C<
`
`ON
`
`D1>
`
`['11W
`
`
`
`
`mU
`
`[T]O
`
`Extended European Search Report dated Aug. 3, 2016, in connection with European Patent
`Application No. 161728266, 13 pages.
`Office Action, dated Aug. 30, 2016, in connection with Korean Patent Application No. 10-2014-
`7024469 |English translationl, 7 pages.
`Invalidation Request, filed June 20, 2016, in connection with Chinese Patent Application No
`200780002006 [English translation, document as filed in Chinese and Notice of acceptance of
`
`invalidation request as issued in Chinese], 174 pages.
`Response, filed Aug. 23, 2016, to Invalidation Request, filed June 20, 2016, in connection with
`Chinese Patent Application No, 200780002006 [English instructions, document as filed in Chinese
`and claims as filed in En_lish]. 118 a_cs.
`N otiee of Oral Hearing, issued Aug, 31, 2016, in connection with Chinese Patent Application No,
`2007 80002006 |English translationl, 5 pages.
`Post Hearing Observations, filed Dec. 8, 2016, on Response, filed Aug, 23, 2016, to lnvalidation
`Request, filed June 20, 2016,in connection with Chinese Patent Application No, 200780002006
`[English instructions for response, document as filed in Chinese and English translation of filed
`claims], 57 pages.
`
`Examiner Signature
`
`Date Considered
`
`/JONATHAN S LAU/
`
`07/181’2017
`
`Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in
`EXAMINER:
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH,
`
`/J.S.L/
`
`