Sheet _1 of _5_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|15730,02039.U§$25/2039E 14/683,415
`Applicant
`Helenekefal.
`Filing Date
`April 10, 2015
`U.S. Patent Documents
`
`Examiner|Desig. Document Publication Filing Date
`
`
`Initial Class|Subclass|If AppropriateID Number Date Patentee
`
`
`
`
`
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Group Art Unit
`1673
`
`
`AA
`7,754,702
`07/13/10
`Heleneketal.
`054
`01/08/2007
`
`8,431,549
`
`04/03/13
`
`Heleneketal.
`
`:
`
`0358
`
`05/25/2010
`
`
`
`Foreign Patent Documents or Published Foreign Patent Applications
`Examiner
`Document
`Publication
`Country or Patent
`Translation
`Initial
`Number
`Date
`Office
`None
`
`
`PGR2020-00009
`
`
`Other Documents (include Author, Title, Date, and Place of Publication
`
`Examiner
`Initial
`
`Letter/Written Disclosure of the initial Information Disclosure Statement for the above-referenced
`
`application, filed herewith on January 27, 2 pages.
`Auerbachet al., "Low-molecular weight iron dextran and iron sucrose have similar comparative
`
`safety profiles in chronic kidney disease," Kidney International 73:528-530 (2008).
`Danielson B.G., "Structure, chemistry, and pharmacokinetics of intravenous iron agents," J Am Soc
`Nephrol 15 Suppl 2:593-598 (2004).
`Decision of the Technical Board of Appeal. dated March 1, 2006, in connection with European
`Patent No. 0679508, 17 pages.
`
`Jahn etal., "A comparative study of the physiochemical properties of iron isomaltoside 1000
`(Monofer), a newintravenous iron preparation and its clinical implications," European J of
`Pharmaceutics and Biopharmaceutics 78:480-491 (2011).
`Johanssonct al., "Intravenous iron isomaltoside 1000 (Monoler®) reduces postoperative anacmia in
`preoperatively non-anacmic paticnts undcrgoing clective or subacute coronaryartery bypassgraft,
`valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical
`trial (the PROTECTtrial)," Vox Sang 109(3):257-266 (2015).
`Kulnigg et al., "A novel intravenousiron formulation for treatment of anemia in inflammatory
`bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial," Am J
`Gastroenterol 103(5):1182-1192 (2008),
`MacDougall et al., "Use of intravenous iron supplementation in chronic kidney disease” Iranian J
`Kidney Dis 7(1):9-22 (2013).
`MacDougall L.C., "Strategics for iron supplementation: Oral versus intravenous" Kidney
`
`International 55(69): $61-66 (1999),
`Reinischet al., "A randomized, open-label, non-infericrity study of intravenous iron isomaltoside
`1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED)," Am J
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`Gastroenterol 108(12):1877-88 (2013).
`Reinischetal., "A 1-year tral of repeated high-dose intravenous iron isomaltoside 1000 to maintain
`stable hemoglobin levels in inflammatory bowel disease," Scand J Gastroenterol 50(10):1226-1233
`(2015).
`Syner-Med, "Summary of Product Characteristics; Ferinject," (2009), 8 pages.
`Office Action, mailed Dec. 15, 2009, in connection with U.S. 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
`
`EXAMINER:Initialif citation considered, whetheror notcitation is in conformance with MPEP 609; Draw line throughcitation if notin
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`Ex. 3003
`Ex. 3003
`PGR2020-00009
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.8.1L/
`
`

`

`Sheet 2 of _5_
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey DocketNo. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|15730.02039.U$25/2039E 14/683,415
`Applicant
`Helenekefal.
`Group Art Unit
`Filing Date
`1673
`April 10, 2015
`Notice of Allowance, mailed April 5, 2010, in connection with U.S. Patent Application Scrial No.
`11/620.986, 12 pages.
`Petition for Inter Partes Review of U.S. Patent No. 7,754,702, mailed June 24, 2015, in connection
`with U.S. Patent Application Serial No. 11/620,986, 65 pages.
`Patent Owner Preliminary Response, dated Oct. 12, 2015, in connection with U.S. Patent
`
`Application Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 39 pages.
`Decision, cntcred Jan. 08, 2016, in connection with U.S. Patent Application Scrial No. 11/620,986
`(U.S. Paicnt No. 7,754,702), 20 pages.
`Order Conduct of the Proceedings, mailed Mar. 11, 2016, in connection with U.S. Patent
`
`Application Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 6 pages.
`Patent Owner Response, mailed Mar. 29, 2016, in connection with U.S. Patent Application Serial
`No. 11/620,986 (U.S. Patent No. 7,754,702), 47 pages.
`Patent Owner Exhibit List as of March 29, 2016, mailed Mar. 29, 2016, in connection with U.S.
`Patent Application Serial No. 11/620,986 (U.S. 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 (U.S. Patent No. 7,754,702), 48 pages.
`Petitioner's Notice of Objections to Evidence, mailed Apr. 5, 2016, in connection with U.S. Patent
`Application Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 5 pages.
`Corrected Patent Owner Exhibit List as of April 25, 2016. mailed Apr. 25. 2016, in connection with
`U.S. Patent Application Scrial No. 11/620,986 (U.S. Patent No. 7,754,702),7 pages.
`Corrected Motion to Amend, mailed Apr. 25, 2016, in connection with U.S. Patent Application
`Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 48 pages.
`Petitioner's Reply to Patent Owner Response, dated June, 20, 2016, in connection with U.S. Patent
`Application Serial No. 11/620,986 (U.S. Patent No. 7,754,702
`Petitioner's Opposition to Patent Owner's Motion to Amend, dated June 20, 2016, in connection
`with U.S. Patent Application Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 31 pages.
`Objections to Petitioner's Reply and Opposition Evidence, dated June 27, 2016, in connection with
`U.S. Patient Application Scrial No. 11/620,986 (U.S. Patcnt No. 7,754,702), 3
`pages.
`Patent Owner Replv to Opposition to Motion to Amend, dated July 19, 2016, in connection with
`U.S. Patent Application Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 20
`.
`Patent Owner Motion to Exclude, dated Aug. 09, 2016, in connection with U.S. Patent Application
`Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 19
`pages.
`Order Conduct of the Proceedings, dated Aug. 19, 2016, in connection with U.S. Patent Application
`Serial No. 11/620,986 (U.S. Patent No. 7,754,702), 3
`pages.
`Order Trial Hearing, dated Aug. 22, 2016, in connection with U.S. Patent Application Serial Nos.
`11/620,986 (U.S. Patent No. 7,754,702), 5 pages.
`Petitioner's Opposition to Patent Owner's Motion to Exclude, dated Aug. 23, 2016, in connection
`with U.S, Patent Application Serial No. 11/620,986 (U.S, Patent No. 7,754,702), 19 pages.
`Paicnt Owncr Reply to Opposition to Motion to Exclude, dated Aug. 30, 2016, in connection with
`U.S. Patent Application Scrial No. 11/620,986 (U.S. Patent No. 7,754,702), 9
`pages.
`Record of Oral Hearing, dated Nov. 03, 2016, in connection with U.S. Patent Application Serial No.
`11/620,986 (U.S. Patent No. 7,754,702), 104 pages.
`Final Written Decision, dated Jan. 4, 2017, in connection with U.S. Patent Application Serial No.
`11/620,986 (U.S. Patent No. 7,754,702), 52 pages.
`Restriction Requirement, dated March 23, 2012, in connection with U.S. Patent Application Serial
`No. 12/787,283, 7 pages.
`Response, dated April 19, 2012, to Restriction Requirement, mailed March 23, 2012, in connection
`with U.S. Patent Application Serial No. 12/787,283, 4 pages.
`Office Action, mailed June 6, 2012, in connection with U.S. Patent Application Serial No.
`12/787,283, 13 pages.
`Response, dated Dec. 6, 2012, to Office Action, mailed June 6, 2012, in connection with U.S. Patent
`Application Serial No. 12/787,283, 34 pages.
`Date Considered
`
`Examiner Signature
`
`
`
`EXAMINER:Initialif citation considered, whetheror notcitation is in conformance with MPEP 609; Draw line through citation if notin
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.8.1L/
`
`

`

`Sheet 3 of _5_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|15730,02039.U§$25/2039E 14/683,415
`Applicant
`Helenekef al.
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Group Art Unit
`Filing Date
`1673
`April 10, 2015
`Applicant-Initiated Interview Summary, mailed Feb. 6, 2013, in connection with U.S. 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 Reviewof U.S. Patent No. 8,431,549, dated June 24, 2015, m connection
`
`with U.S. Patent Application Serial No. 12/787,283, 67 pages.
`Paicnt Owner Preliminary Response. dated Oct. 12, 2015, in connection with U.S. Patent
`ApplicationSerial No. 12/787,283 (U.S. Patent No. 8.431,549), 65 pages.
`Order Conduct of the Proceeding, entered Oct. 14, 2015, in connection with U.S. Patent Application
`
`Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 4 pages.
`Notice of Response in lieu of Motion, dated Oct. 20, 2015, in connection with U.S. Patent
`Application Serial No. 12/787,283 (U.S. Patent No.,43 1,549), 4 pages.
`Petitioner's Objection to Patent Owner Response in Lieu of Motion, dated Oct. 30, 2015, in
`connection with U.S. Patent Application Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 4
`pages.
`Inter Partes Review Decision, entered Jan. 08, 2016, in connection with U.S. Patent Application
`Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 24 pages.
`Request for Rehearing, dated Jan. 22, 2016, in connection with U.S. Patent Application Serial No.
`12/787,283 (U.S. Patent No. 8,431,549), 8 pages.
`Patent Owner Objections to Evidence, dated Jan. 27, 2016, in connection with U.S. Patent
`Application Serial No. 12/787,283 (U.S. Patent No. 8,431,549}, 4 pages.
`Revised Patent Owner Notice of Deposition of Dr. Linhardt, dated Feb. 19, 2016, in connection
`
`with U.S. Patent Application Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 3 pages.
`Decision Denying Petitioner's Request for Rehearing, entered Feb. 26, 2016, in connection with
`
`U.S. Patent Application Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 5 pages.
`Order re Conference Call on March 09, 2016, entered Mar. 11, 2016, in connection with U.S. Patent
`Application Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 6 pages.
`Paicnt Owner Exhibit List as of July 19, 2016 in connection with U.S. Patent Application Scrial No.
`12/787.283 (U.S. Patent No. 8,431,549), 7 pages.
`Patent Owner Reply to Opposition to Motion to Amend, dated July 19, 2016, in connection with
`U.S. Patent Application Serial No. 12/787,283 (U.S. Patent No. $.431,549), 20
`.
`Order Trial Hearing, dated Aug. 22. 2016, in connection with U.S. Patent Application Serial No.
`12/787,283 (U.S. Patent No. 8,431,549),
`5
`.
`Record of Oral Hearing, dated Nov. 03, 2016, in connection with U.S. Patent Application Serial No.
`12/787.283 (U.S. Patent No. 8,431,549), 104 pages.
`Inter Partes Review Final Written Decision, filed Dec, 28, 2016, in connection with U.S. Patent
`Application Serial No. 12/787,283 (U.S. Patent No. 8,431,549), 28 pages.
`Restriction Requirement, mailed Dec. 30, 2013, in connection with U.S. Patent Application Serial
`No. 13/847,254, 7 pages.
`Response, dated Feb. 28, 2014, to Restriction Requirement, mailed Dec. 30, 2013, in connection
`with U.S. Patent Application Scrial No. 13/847,254, 4 pages.
`Office Action, mailed Apr. 07, 2014, in connection with U.S. Patent Application Serial No.
`
`13/847,254, 17 pages.
`Response, dated July 03, 2014, to Office Action, mailed Apr. 07, 2014, in connection with U.S.
`Patent Application Serial No. 13/847,254, 18 pages.
`Office Action, mailed Oct. 14, 2014, in connection with U.S. Patent Application Serial No.
`13/847.254, 14 pages.
`Office Action, mailed Feb. 7, 2014, in connection with U.S. Patent Application Serial No.
`14/100.717, 15 pages.
`Response,filed June 9, 2014, to Office Action, mailed Feb. 7, 2014, in connection with U.S. Patent
`Application Serial No. 14/100,717, 19 pages.
`
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`
`Examiner Signature
`
`Date Considered
`
`EXAMINER:Initialif citation considered, whetheror notcitation is in conformance with MPEP 609; Draw line through citation if notin
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.8.1L/
`
`

`

`Sheet 4 of _5_
`
`in connection with
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`DO
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey DocketNo. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|15730.02039.U$25/2039E 14/683,415
`Applicant
`Helenekefal.
`Group Art Unit
`Filing Date
`1673
`April 10, 2015
`Notice of Allowance, mailed Sept. 22, 2014, m connection with U.S. Patent Application Scrial 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
`with U.S. 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 U.S. Patent Application Serial No. 14/100,717 (U.S. Patent No.
`8,895,612), 70 pages.
`Decision Denying Institution of Inter Parics Review, entered Jan. 8, 2016, in connection with U.S.
`Patent Application Scrial No. 14/100,717 (U.S. Patent No. 8,895,612), 23
`pages.
`Response, dated May 17, 2013, to Office Action issued in connection with Australian Patent
`Application No. 2007205167, 28
`Notice of Acceptance, mailed June 04, 2013, in connection with Australian Patent Application No.
`2007205167, | page.
`Examination Report, issued Apr. 13, 2015, in connection with Australian Patent Application No.
`2013206429, 4 pages.
`to Examination Repart, 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, issucd Jan. 11, 2017, in connection with Australian Patcnt Application No.
`2016205002, 5
`pages.
`Response, dated July 4, 2013, to Examiner's Report, issued Jan. 4, 2013, in connection with
`
`Canadian Patent Application No. 2,635,894, 26 pages.
`Examiner's Report, issued Oct. 17, 2013, in connection with Canadian Patent Application No.
`
`2,635,894, 4 pages.
`Response, dated April 16, 2014, to Examiner's Report, issued Oct. 17, 2013,
`Canadian Patent Application No. 2,635,894, 33
`pe
`Examiner's Report, issucd Oct. 10, 2014. in connection with Canadian Patcnt Application No.
`2,635,894, 7 pages.
`Response, dated April 8, 2015, to Examiner's Report, issued Oct. 10, 2014, in connection with
`Canadian Patent Application No. 2,635,894, 30
`Examiner's Report, issued Sept. 29, 2015, in connection with Canadian Patent Application No.
`2,635,894, 8 pages.
`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, issucd May 10, 2011, in connection with European Patent Application No.
`07716309.5, 6
`Response, dated Dec. 14, 2012, to Examination Report, dated June 4, 2012, in connection with
`
`European Patent Application No. 07716309.5, 17 pages.
`Response, dated Jan. 15, 2014, to Examination Report, dated July 5, 2013, in connection with
`European Patent Application No. 07716309.5, 19 pages.
`Third Party Observations, submitted Oct. 31, 2014, and Communication pursuant to Rule 1142)
`EPC,dated Nov. 10, 2014, in connection with European Patent Application No. 07716309.5 [Third
`party observations, Communication and cited references], 22 pages.
`Summons to Attend Oral Proceedings, dated Feb. 9, 2015, issued in connection with European
`DN
`Patent Application No. 07716309.5, 4 pages.
`Response, dated Oct. 30, 2015, to Summonsto Attend Oral Proceedings, dated Feb. 9, 2015, in
`connection with European Patent Application No. 07716309.5, 98 pages.
`Date Considered
`
`
`
`
`Examiner Signature
`
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`EXAMINER:Initialif citation considered, whetheror notcitation is in conformance with MPEP 609; Draw line through citation if notin
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.8.1L/
`
`

`

`Sheet 5 of _5_
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`(37 CFR §1.98(b))
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey DocketNo. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|15730.02039.U$25/2039E 14/683,415
`Applicant
`Helenekefal.
`Group Art Unit
`Filing Date
`1673
`April 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 No.
`07716309.5, 4 pages.
`Response, dated Nov. 27, 2015, to Notice Concerning the Oral Proceedings, dated Nov. 19, 2015, in
`connection with European Patent Application No. 07716309.5, 67 pages.
`Decision to Grant, dated June 23, 2016, issued in connection with European Patent Application No.
`07716309.5, 2 pages.
`Examination Report, issued April 7, 2014, in connection with European Patent Application No.
`13166988.9, 4 pages.
`Response, dated Oct. 17, 2014, to Examination Report, issued April 7, 2014, in connection with
`European Patent Application No. 13166988.9, 13
`Third Party Observations, submitted Nov. 03, 2014, in connection with European Patent
`Application No. 13166988.9, 2
`pa
`Summonsto Attend Oral Proceedings, dated Feb. 10, 2015, in connection with European Patent
`Application No. 13166988.9, 6 pages.
`Response, dated Oct. 30, 2015, to Summons to Attend Oral Proceedings, dated Feb. 10, 2015, in
`connection with European Patent Application No. 13166988.9, 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.
`13 166988.9, 4 pages.
`Response, dated Nov. 23, 2015, to Summons to Attend Oral Procecdings, dated Feb. 10, 2015, in
`connection with European Patent Application No. 13166988.9, 13
`pez
`Communication fromthe Patent Office, issued Nov. 30, 2015, in connection with EuropeanPatent
`lication No. 13166988.9, 1
`page.
`
`in connection with European Patent Application No.
`
`65 pages.
`Intention to Grant, dated Dec. 22, 2015,
`13166988.9, 7
`Extended European Scarch Report, dated Aug. 3, 2016, in connection with Europcan Patent
`
`Application No. 16172826.6, 13 pages.
`Office Action, dated Aug. 30, 2016, in connection with Korean Patent Application No. 10-2014-
`
`7024469 |English translation], 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 Junc 20, 2016, in connection with
`Chinese Patent Application No. 200780002006 [English instructions, documentas filed in Chinese
`and claimsas filed in English], 118 pages.
`Notice of Oral Hearing, issued Aug. 31, 2016, in connection with Chinese Patent Application No.
`200780002006 |English translation], 5 pages.
`Post Hearing Observations, filed Dec. 8, 2016, on Response,filed Aug. 23, 2016, to Invalidation
`Request, filed June 20, 2016,in connection with Chinese Patent Application No. 200780002006
`[Englishinstructions for response, document as filed in Chinese and Englishtranslationof filed
`claims], 57 pages.
`
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`
`Examiner Signature
`
`Date Considered
`
`/JONATHAN S LAU/
`
`07/18/2017
`
`EXAMINER:Initialif citation considered, whetheror notcitation is in conformance with MPEP 609; Draw line through citation if notin
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.8.1L/
`
`