Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 1 of 46 PageID #: 1489
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Plaintiffs and Counter Defendants,
`
`v.
`
`CELLTRION, INC., CELLTRION,
`HEALTHCARE CO., LTD., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH,
`
`C.A. No. 18-95-CFC
`(CONSOLIDATED)
`
`
`C.A. No. 18-924-CFC
`
`C.A. No. 18-1363-CFC
`
`
`GENENTECH, INC., CITY OF HOPE, and )
`HOFFMANN LA ROCHE INC.,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`Defendants and Counterclaim Plaintiffs. )
`)
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`
`AMGEN INC.,
`
`Defendant and Counterclaim Plaintiff.
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD,
`
`Defendant and Counterclaim Plaintiff.
`
`
`
`JOINT CLAIM CONSTRUCTION CHART
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 2 of 46 PageID #: 1490
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`
`
`Pursuant to the Court’s Scheduling Order in the above-captioned cases,
`
`Plaintiffs Genentech, Inc., City of Hope, and Hoffman La Roche Inc. (“Plaintiffs”)
`
`and Defendants Celltrion,
`
`Inc., Celltrion Healthcare Co. Ltd., Teva
`
`Pharmaceuticals USA, Inc., and Teva Pharmaceuticals International GMBH
`
`(Defendant Group1 “Celltrion/Teva”), Amgen Inc. (Defendant Group “Amgen”),
`
`and Samsung Bioepis Co., Ltd (Defendant Group “Samsung”) have met and
`
`conferred, and present the following Joint Claim Construction Chart for the terms
`
`in dispute for each of the patents currently asserted in these cases. The following
`
`table lists the asserted patents and the claims of each patent that Plaintiffs presently
`
`assert each Defendant Group infringes.
`
`PATENT
`6,627,196
`
`CLAIMS/DEFENDANT GROUP
`11, 22 (Celltrion/Teva, Amgen, Samsung)
`7, 27 (Celltrion/Teva)
`11, 21 (Celltrion/Teva, Amgen, Samsung)
`7 (Celltrion/Teva)
`U.S. App. No. 14/073,6592 10 (Amgen, Samsung)
`11 (Celltrion/Teva, Amgen, Samsung)
`
`7,371,379
`
`
`1 “Defendant Group” shall be defined to include all parties sued by Plaintiffs in a
`single cause of action.
`2 At this time, Defendants do not object to Plaintiffs’ inclusion of this patent
`application in its November 7 list of narrowed patents for claim construction and
`trial, as a placeholder for the patent that may eventually issue from the App. No.
`14/073,659. Plaintiffs assert that they will take appropriate steps to add the patent
`to the complaints when it issues, and Defendants reserve all rights to object to
`Plaintiffs’ efforts to do so, including if the patent does not timely issue, or if the
`current claims are further amended.
`
`2
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 3 of 46 PageID #: 1491
`
`
`
`PATENT
`7,993,834
`8,076,066
`8,574,869
`6,407,213
`8,512,983
`9,714,293
`7,485,704
`7,390,660
`6,620,918
`9,249,218
`
`
`CLAIMS/DEFENDANT GROUP
`2, 5 (Celltrion/Teva, Amgen, Samsung)
`2, 6 (Celltrion/Teva, Amgen)
`5, 8 (Celltrion/Teva, Amgen, Samsung)
`79, 65 (Celltrion/Teva, Amgen, Samsung)
`2, 19 (Amgen, Samsung)
`72, 73 (Amgen, Samsung)
`6, 12 (Celltrion/Teva, Samsung)
`3, 6 (Samsung)
`5, 7 (Amgen)
`1, 2 (Celltrion/Teva)
`
`The charts below identify the parties’ proposed constructions for the
`
`disputed claim terms and the parties’ identification of intrinsic evidence in support
`
`of their proposed constructions. Also provided is a list of terms and their proposed
`
`constructions on which the parties have agreed. Each party reserves the right to
`
`supplement the charts below with additional evidence and to rely upon additional
`
`intrinsic evidence and/or extrinsic evidence in its claim construction briefs to
`
`respond to or rebut evidence and arguments made by another party, and to rely
`
`upon another party’s intrinsic evidence.
`
`Appendix A sets forth a list of claim terms and their respective constructions
`
`on which the parties have agreed. Appendix B sets forth the disputed claim terms,
`
`the constructions proposed by the parties, and the intrinsic evidence each side
`
`believes supports its proposed constructions. Copies of the relevant patents and
`
`3
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 4 of 46 PageID #: 1492
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`
`
`portions of the intrinsic evidence relied upon by the parties are attached as
`
`Appendix C.
`
`
`
`
`
`4
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 5 of 46 PageID #: 1493
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`
`Appendix A – Terms Not in Dispute
`
`Claim Term and Claim
`“A method of identifying and treating a
`breast cancer patient disposed to respond
`favorably to a HER2 antibody,
`huMAb4D5-8”
`’066 Patent, Claims 2, 6
`“A method for the prevention of the
`reduction of a disulfide bond in an antibody
`expressed in a recombinant host cell”
`’869 Patent, Claims 5, 8
`“sparging”
`’869 Patent, Claims 5, 8
`“harvested culture fluid”
`’869 Patent, Claims 5, 8
`“eluting the mixture at a gradient of about
`0-1 M of an elution salt”
`’918 Patent, Claims 5, 7
`
`“A method for reducing glucose
`consumption during cultivation”
`’660 Patent, Claim 3
`“A method for reducing lactate production
`during cultivation”
`’660 Patent, Claim 6
`
`
`
`Agreed Construction
`The preamble is limiting
`
`The preamble is limiting
`
`bubbling of a gas into a liquid
`
`culture fluid that has been harvested
`
`eluting the mixture starting at a first
`concentration between 0 and 1 M of
`an elution salt and ending at a second
`higher concentration between 0 and 1
`M of the elution salt
`The preamble is limiting
`
`The preamble is limiting
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 6 of 46 PageID #: 1494
`
`
`Appendix B – Terms in Dispute
`
`“initial dose”
`(’196 Patent, claims 11, 22; ’379 Patent, claims 11, 21;
`App. No. 14/073,659, claims 10, 11)3
`
`
`Plaintiffs’ Proposal
`initial single dose or initial series of
`doses
`
`
`Defendants’ Proposal
`Amgen: “the first dose of the claimed
`antibody given to the patient as part of a
`treatment regimen”
`
`Celltrion/Teva and Samsung: “the first
`dose of the claimed antibody given to the
`patient as part of a treatment regimen,
`also known as the loading dose”
`
`
`Intrinsic Evidence:
`
`Intrinsic Evidence:
`
`’196 Patent,4 including: 4:21-29; 4:39-
`41; 4:56-59; 4:60-5:8; 5:12-15; 19:19-
`45; 33:59-64; 34:31-34; 43:64-44:1;
`44:11-44:21; 44:57-65; 45:5-7; claims
`1-33.
`
`’196 Patent Prosecution File History,
`Application No. 09/648,067, including:
`Non-Final Rejection (Mar. 28, 2002);
`Applicant Arguments/Remarks Made in
`Amendment (Aug. 28, 2002); Final
`Rejection (Dec. 3, 2002); Applicant
`Arguments/Remarks Made in
`Amendment (Mar. 3, 2003).
`
`’379 Patent claims 1-40.
`
`’379 Patent Prosecution File History,
`Application No. 10/600,152, including:
`Non-Final Rejection (Aug. 9, 2006);
`Applicant Arguments/Remarks Made in
`
`3 ʼ196 Patent, claim 7 and ʼ379 Patent, claim 7 are asserted only against
`Celltrion/Teva.
` 14/073,659 Application, claim 10 is not asserted against
`Celltrion/Teva.
`4 The ’196 Patent, ’379 Patent, and ’659 Patent App. share a specification. This
`chart cites to the ’196 Patent specification for ease of reference. The disclosure is
`the same in the ’379 Patent and ’659 Patent App.
`
`
`
`’196 Patent, including: Claims 1-16; Fig.
`3; 1:18-23; 3:54-65; 4:21-5:48; 6:20-46;
`7:6-21; 8:33-39; 15:11-24; 18:13-48;
`19:19-45; 33:7-15; 33:65-34:34; 35:20-
`48:4 (Examples 1-6 and Tables 1-7).
`
`’379 Patent, including Claims 1-15; Fig.
`3; 1:20-25; 3:59-4:3; 4:26-5:51; 6:23-49;
`7:9-25; 8:38-44; 15:17-30; 18:18-53;
`19:24-48; 33:18-26; 34:11-49; 35:38-
`48:42 (Examples 1-6 and Tables 1-7).
`
`Application No. 14/073,659, Claims 1
`and 11 of the Amended Claims dated
`October 5, 2018. Application No.
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 7 of 46 PageID #: 1495
`
`
`Plaintiffs’ Proposal
`Amendment (Feb. 2, 2007); Final
`Rejection (May 4, 2007).
`
`’659 Patent App. claims 1, 10, 11.
`
`Defendants’ Proposal
`14/073,659, Specification and Drawings
`dated November 6, 2013, as amended
`January 6, 2016, Fig. 3; 1:15-18; 3:26-
`31; 4:6-39; 5:3-10; 5:13-14; 5:36-6:10;
`6:25-6:33; 7:36-39; 14:3-10; 16:32-
`17:11; 17:32-18:6; 30:26-30; 31:20-39;
`33:3-46:10 (Examples 1-6 and Tables 1-
`7).
`
`’196 Patent File History, Application No.
`09/648,067, Original Application filed on
`August 25, 2000; Office Action dated
`December 18, 2001; Response to Office
`Action dated January 18, 2002; Office
`Action dated March 28, 2002;
`Amendment and Response to Office
`Action dated August 28, 2002; Office
`Action dated December 3, 2002;
`Response to Office Action dated March
`3, 2003; Examiner Interview Summary
`Record dated April 28, 2003; Applicant
`Interview Summary Record dated May
`27, 2003; Amendment and Response to
`Office Action dated May 29, 2003;
`Notice of Allowance dated June 5, 2003;
`Examiner Interview Summary Record
`dated June 6, 2003.
`
`Baselga et al., Phase II Study of Weekly
`Intravenous Recombinant Humanized
`Anti-p185HER2 Monoclonal Antibody in
`Patients With HER2/neu-Overexpressing
`Metastatic Breast Cancer, J. CLIN.
`ONCOL. 14(3):737-744 (Mar. 1996).
`
`Pegram et al., Phase II Study of
`Receptor-Enhanced Chemosensitivity
`Using Recombinant Humanized Anti-
`pl85HER2 /neu Monoclonal Antibody Plus
`7
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 8 of 46 PageID #: 1496
`
`
`Plaintiffs’ Proposal
`
`Defendants’ Proposal
`Cisplatin in Patients With HER2/neu-
`Overexpressing Metastatic Breast
`Cancer Refractory to Chemotherapy
`Treatment, J. CLIN. ONCOL. 16(8):2659-
`2671 (1998).
`
`’379 Patent File History, Application No.
`10/600,152, Divisional Application filed
`on June 20, 2003; Office Action dated
`May 11, 2006; Amendment and
`Response to Office Action dated May 24,
`2006; Office Action dated August 9,
`2006; Response to Office Action dated
`February 9, 2007; Office Action dated
`May 4, 2007; Amendment and Response
`to Office Action dated October 4, 2007;
`Notice of Allowance dated December 28,
`2007; Examiner Interview Summary
`Record dated January 4, 2008.
`
`Application No. 11/443,943 File History,
`Application No. 11/443,943, Divisional
`Application filed on May 31, 2006;
`Office Action dated January 9, 2008;
`Amendment and Response to Office
`Action dated July 2, 2008; Office Action
`dated October 29, 2008; Amendment and
`Response to Office Action dated January
`29, 2009; Office Action dated May 14,
`2009; Amendment and Response to
`Office Action dated August 14, 2009;
`Advisory Action dated September 11,
`2009; Request for Continued
`Examination dated May 7, 2010; Office
`Action dated December 23, 2010;
`Abandonment dated July 11, 2011.
`
`Application No. 13/167,599 File History,
`Application No. 13/167,599, Divisional
`8
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 9 of 46 PageID #: 1497
`
`
`Plaintiffs’ Proposal
`
`
`
`Defendants’ Proposal
`Application filed on June 23, 2011;
`Abandonment dated April 17, 2012.
`
`Application No. 13/415,271 File History,
`Divisional Application filed on March 8,
`2012; Preliminary Amendment dated
`February 19, 2013; Office Action dated
`July 18, 2013; Abandonment dated
`February 20, 2014.
`
`Application No. 14/073,659,
`Continuation Application filed on
`November 6, 2013; Office Action dated
`August 6, 2015; Applicant Initiated
`Interview Summary dated November 19,
`2015; Amendment and Response to
`Office Action dated January 6, 2016;
`Terminal Disclaimer dated January 6,
`2016; Office Action dated November 18,
`2016; Examiner and Applicant Initiated
`Summaries dated May 3, 2017;
`Amendment and Response to Office
`Action dated May 17, 2017; Office
`Action dated July 6, 2018; Applicant
`Initiated Interview Summary dated
`September 13, 2018; Amendment and
`Response to Office Action dated October
`5, 2018; Notice of Allowance dated
`October 23, 2018.
`
`
`
`Plaintiffs’ Proposal
`Plain meaning
`
`
`Intrinsic Evidence:
`
`“first dose”
`(’196 Patent, claim 27)
`
`
`Celltrion/Teva’s Proposal
`“the first dose of the claimed antibody
`given to the patient as part of a treatment
`regimen, also known as the loading
`9
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 10 of 46 PageID #: 1498
`
`
`Plaintiffs’ Proposal
`’196 Patent, including: 6:20-43; 6:62-
`7:1; 46:63-65; claims 1-33.
`
`’379 Patent claims 1-40.
`
`’379 Patent Prosecution File History,
`Application No. 10/600,152, including:
`Non-Final Rejection (Aug. 9, 2006);
`Applicant Arguments/Remarks Made in
`Amendment (Feb. 2, 2007); Final
`Rejection (May 4, 2007).
`
`Celltrion/Teva’s Proposal
`
`dose”
`
`
`Intrinsic Evidence:
`
`
`’196 Patent, including: Claims 1-16; Fig.
`3; 1:18-23; 3:54-65; 4:21-5:48; 6:20-46;
`7:6-21; 8:33-39; 15:11-24; 18:13-48;
`19:19-45; 33:7-15; 33:65-34:34; 35:20-
`48:4 (Examples 1-6 and Tables 1-7).
`
`’379 Patent, including Claims 1-15; Fig.
`3; 1:20-25; 3:59-4:3; 4:26-5:51; 6:23-49;
`7:9-25; 8:38-44; 15:17-30; 18:18-53;
`19:24-48; 33:18-26; 34:11-49; 35:38-
`48:42 (Examples 1-6 and Tables 1-7).
`
`Application No. 14/073,659, Claims 1
`and 11 of the Amended Claims dated
`October 5, 2018. Application No.
`14/073,659, Specification and Drawings
`dated November 6, 2013, as amended
`January 6, 2016, Fig. 3; 1:15-18; 3:26-
`31; 4:6-39; 5:3-10; 5:13-14; 5:36-6:10;
`6:25-6:33; 7:36-39; 14:3-10; 16:32-
`17:11; 17:32-18:6; 30:26-30; 31:20-39;
`33:3-46:10 (Examples 1-6 and Tables 1-
`7).
`
`’196 Patent File History, Application No.
`09/648,067, Original Application filed on
`August 25, 2000; Office Action dated
`December 18, 2001; Response to Office
`Action dated January 18, 2002; Office
`Action dated March 28, 2002;
`Amendment and Response to Office
`Action dated August 28, 2002; Office
`Action dated December 3, 2002;
`Response to Office Action dated March
`3, 2003; Examiner Interview Summary
`10
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 11 of 46 PageID #: 1499
`
`
`Plaintiffs’ Proposal
`
`Celltrion/Teva’s Proposal
`Record dated April 28, 2003; Applicant
`Interview Summary Record dated May
`27, 2003; Amendment and Response to
`Office Action dated May 29, 2003;
`Notice of Allowance dated June 5, 2003;
`Examiner Interview Summary Record
`dated June 6, 2003.
`
`Baselga et al., Phase II Study of Weekly
`Intravenous Recombinant Humanized
`Anti-p185HER2 Monoclonal Antibody in
`Patients With HER2/neu-Overexpressing
`Metastatic Breast Cancer, J. CLIN.
`ONCOL. 14(3):737-744 (Mar. 1996).
`
`Pegram et al., Phase II Study of
`Receptor-Enhanced Chemosensitivity
`Using Recombinant Humanized Anti-
`pl85HER2 /neu Monoclonal Antibody Plus
`Cisplatin in Patients With HER2/neu-
`Overexpressing Metastatic Breast
`Cancer Refractory to Chemotherapy
`Treatment, J. CLIN. ONCOL. 16(8):2659-
`2671 (1998).
`
`’379 Patent File History, Application No.
`10/600,152, Divisional Application filed
`on June 20, 2003; Office Action dated
`May 11, 2006; Amendment and
`Response to Office Action dated May 24,
`2006; Office Action dated August 9,
`2006; Response to Office Action dated
`February 9, 2007; Office Action dated
`May 4, 2007; Amendment and Response
`to Office Action dated October 4, 2007;
`Notice of Allowance dated December 28,
`2007; Examiner Interview Summary
`Record dated January 4, 2008.
`
`11
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 12 of 46 PageID #: 1500
`
`
`Plaintiffs’ Proposal
`
`Celltrion/Teva’s Proposal
`Application No. 11/443,943 File History,
`Application No. 11/443,943, Divisional
`Application filed on May 31, 2006;
`Office Action dated January 9, 2008;
`Amendment and Response to Office
`Action dated July 2, 2008; Office Action
`dated October 29, 2008; Amendment and
`Response to Office Action dated January
`29, 2009; Office Action dated May 14,
`2009; Amendment and Response to
`Office Action dated August 14, 2009;
`Advisory Action dated September 11,
`2009; Request for Continued
`Examination dated May 7, 2010; Office
`Action dated December 23, 2010;
`Abandonment dated July 11, 2011.
`
`Application No. 13/167,599 File History,
`Application No. 13/167,599, Divisional
`Application filed on June 23, 2011;
`Abandonment dated April 17, 2012.
`
`Application No. 13/415,271 File History,
`Divisional Application filed on March 8,
`2012; Preliminary Amendment dated
`February 19, 2013; Office Action dated
`July 18, 2013; Abandonment dated
`February 20, 2014.
`
`Application No. 14/073,659,
`Continuation Application filed on
`November 6, 2013; Office Action dated
`August 6, 2015; Applicant Initiated
`Interview Summary dated November 19,
`2015; Amendment and Response to
`Office Action dated January 6, 2016;
`Terminal Disclaimer dated January 6,
`2016; Office Action dated November 18,
`2016; Examiner and Applicant Initiated
`12
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 13 of 46 PageID #: 1501
`
`
`Plaintiffs’ Proposal
`
`Celltrion/Teva’s Proposal
`Summaries dated May 3, 2017;
`Amendment and Response to Office
`Action dated May 17, 2017; Office
`Action dated July 6, 2018; Applicant
`Initiated Interview Summary dated
`September 13, 2018; Amendment and
`Response to Office Action dated October
`5, 2018; Notice of Allowance dated
`October 23, 2018.
`
`
`
`
`“subsequent dose(s)”
`(’196 Patent, claims 7, 11, 22, 27; ’379 Patent, claims 7, 11, 21; 14/073,659
`Application, claims 10, 11)5
`
`
`Plaintiffs’ Proposal
`Plain meaning
`
`
`Celltrion/Teva’s Proposal
`“the doses immediately following the
`initial or first dose of the claimed
`antibody administered in a regimen”
`
`
`Intrinsic Evidence:
`
`’196 Patent, including: 4:21-26; 4:39-
`41; 4:50-53; 4:61-67; 5:12-15; 5:30-48;
`6:20-46; 6:54-7:1; 7:13-21; 18:28-31;
`19:31-33; 33:7-11; 34:10-34; 37:12-16;
`38:39-43; 39:4-8; 43:48-52; 44:11-21;
`45:5-7; 45:18-22; 46:63-47:5; claims 1,
`5, 24, 25, 30.
`
`’196 Patent Prosecution File History,
`Application No. 09/648,067, including:
`Non-Final Rejection (Mar. 28, 2002);
`Applicant Arguments/Remarks Made in
`Amendment (Aug. 28, 2002); Final
`Rejection (Dec. 3, 2002); Applicant
`
`5 ʼ196 Patent, claim 7 and ʼ379 Patent, claim 7 are asserted only against
`Celltrion/Teva.
` 14/073,659 Application, claim 10 is not asserted against
`Celltrion/Teva.
`
`Intrinsic Evidence:
`
`
`’196 Patent, including: Claims 1-15; Fig.
`3; 1:18-23; 3:54-65; 4:21-5:48; 5:45-48;
`6:20-46; 7:6-21; 8:33-39; 15:11-24;
`18:13-48; 19:19-45; 33:7-15; 33:65-
`34:34; 35:20-48:4 (Examples 1-6 and
`Tables 1-7).
`
`’196 Patent File History, Application No.
`09/648,067, Original Application filed on
`August 25, 2000; Office Action dated
`December 18, 2001; Response to Office
`Action dated January 18, 2002; Office
`
`13
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 14 of 46 PageID #: 1502
`
`
`Plaintiffs’ Proposal
`Arguments/Remarks Made in
`Amendment (Mar. 3, 2003).
`
`’379 Patent, claims 1, 5, 30, 31, 36.
`
`’379 Patent Prosecution File History,
`Application No. 10/600,152, including:
`Non-Final Rejection (Aug. 9, 2006);
`Applicant Arguments/Remarks Made in
`Amendment (Feb. 2, 2007); Final
`Rejection (May 4, 2007).
`
`Celltrion/Teva’s Proposal
`Action dated March 28, 2002;
`Amendment and Response to Office
`Action dated August 28, 2002; Office
`Action dated December 3, 2002;
`Response to Office Action dated March
`3, 2003; Examiner Interview Summary
`Record dated April 28, 2003; Applicant
`Interview Summary Record dated May
`27, 2003; Amendment and Response to
`Office Action dated May 29, 2003;
`Notice of Allowance dated June 5, 2003;
`Examiner Interview Summary Record
`dated June 6, 2003.
`
`’379 Patent File History, Application No.
`10/600,152, Divisional Application filed
`on June 20, 2003; Office Action dated
`May 11, 2006; Amendment and
`Response to Office Action dated May 24,
`2006; Office Action dated August 9,
`2006; Response to Office Action dated
`February 9, 2007; Office Action dated
`May 4, 2007; Amendment and Response
`to Office Action dated October 4, 2007;
`Notice of Allowance dated December 28,
`2007; Examiner Interview Summary
`Record dated January 4, 2008.
`
`Application No. 11/443,943 File History,
`Application No. 11/443,943, Divisional
`Application filed on May 31, 2006;
`Office Action dated January 9, 2008;
`Amendment and Response to Office
`Action dated July 2, 2008; Office Action
`dated October 29, 2008; Amendment and
`Response to Office Action dated January
`29, 2009; Office Action dated May 14,
`2009; Amendment and Response to
`Office Action dated August 14, 2009;
`14
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 15 of 46 PageID #: 1503
`
`
`Plaintiffs’ Proposal
`
`Celltrion/Teva’s Proposal
`Advisory Action dated September 11,
`2009; Request for Continued
`Examination dated May 7, 2010; Office
`Action dated December 23, 2010;
`Abandonment dated July 11, 2011.
`
`Application No. 13/167,599 File History,
`Application No. 13/167,599, Divisional
`Application filed on June 23, 2011;
`Abandonment dated April 17, 2012.
`
`Application No. 13/415,271 File History,
`Divisional Application filed on March 8,
`2012; Preliminary Amendment dated
`February 19, 2013; Office Action dated
`July 18, 2013; Abandonment dated
`February 20, 2014.
`
`Application No. 14/073,659,
`Continuation Application filed on
`November 6, 2013; Office Action dated
`August 6, 2015; Applicant Initiated
`Interview Summary dated November 19,
`2015; Amendment and Response to
`Office Action dated January 6, 2016;
`Terminal Disclaimer dated January 6,
`2016; Office Action dated November 18,
`2016; Examiner and Applicant Initiated
`Summaries dated May 3, 2017;
`Amendment and Response to Office
`Action dated May 17, 2017; Office
`Action dated July 6, 2018; Applicant
`Initiated Interview Summary dated
`September 13, 2018; Amendment and
`Response to Office Action dated October
`5, 2018; Notice of Allowance dated
`October 23, 2018.
`
`15
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 16 of 46 PageID #: 1504
`
`
`“A method for increasing likelihood of effectiveness of breast cancer treatment
`with humanized anti-ErbB2 antibody huMAb4D5-8”
`(’834 Patent, claims 2, 5)
`
`
`Plaintiffs’ Proposal
`A method of treatment of patients who
`have a greater likelihood of responding
`to treatment by administering
`humanized anti-ErbB2 antibody
`huMAb4D5-8
`The preamble is limiting.
`
`
`Intrinsic Evidence:
`
`’834 Patent, including: 3:14-27; 3:64-
`4:43; Table 3, Table 4, Table 5, Table 6,
`Table 7, Table 8, Table 9; 22:12-28;
`20:63-67.
`
`’834 Patent Prosecution File History,
`Application No. 11/942,449, including:
`Office Action (June 11, 2009);
`Response to Office Action (Sept. 11,
`2009); Office Action (Jan. 7, 2010);
`Office Action Response (Apr. 7, 2010);
`Office Action (June 23, 2010); Office
`Action Response (Oct. 25, 2010);
`Advisory Action (Nov. 24, 2010);
`Supplemental Response to Office
`Action After Notice of Appeal (Nov.
`29, 2010).
`
`Application No. 09/863,101
`Prosecution File History, including the
`Office Action Response (Sept. 2, 2005).
`
`Defendants’ Proposal
` The
`The preamble
`is
`limiting.
`preamble cannot properly be construed
`so as to provide reasonable certainty
`regarding
`the claim scope.
` The
`proposed construction does not resolve
`this issue.
`
`
`Intrinsic Evidence:
`
`
`’834 Patent, including Claims 1-2;
`Abstract, 1:19-23, 2:36-38, 2:54-3:27,
`3:41-4:43, 4:21-29; 5:62-67, 15:47-55,
`18:57-22:41 (Examples 1-2 and Tables
`1-9).
`
`Application No. 09/863,101 File
`History, Application No. 09/863,101,
`Original Application filed on May 18,
`2001; Office Action dated September
`25, 2002; Response to Office Action
`dated October 22, 2002; Office Action
`dated December 31, 2002; Amendment
`and Response to Office Action dated
`May 29, 2003; Office Action dated
`August 25, 2003; Notice of Appeal
`dated January 29, 2004; Amendment
`and Response to Office Action and
`RCE dated June 24, 2004; Office
`Action dated September 16, 2004;
`Examiner Interview Summary Record
`dated October 19, 2004; Amendment
`and Response to Office Action dated
`November 9, 2004; Office Action
`dated March 14, 2005; Amendment
`16
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 17 of 46 PageID #: 1505
`
`
`Plaintiffs’ Proposal
`
`Defendants’ Proposal
`and Response to Office Action dated
`July 13, 2005; Office Action dated
`September 27, 2005; Amendment and
`Response to Office Action dated March
`27, 2006; Office Action dated June 20,
`2006; Abandonment dated June 27,
`2007.
`
`Application No. 11/441,995 File
`History. Application No. 11/441,995,
`Divisional Application filed on May
`26, 2006; Office Action dated
`September 22, 2006; Response to
`Office Action dated October 23, 2006;
`Office Action dated January 16, 2007;
`Response to Office Action dated
`February 16, 2007; Office Action dated
`May 17, 2007; Abandonment dated
`December 28, 2007.
`
`’834 Patent File History. Application
`No. 11/942,449, Continuation
`Application filed on November 19,
`2007; Office Action dated June 11,
`2009; Response to Office Action dated
`September 11, 2009; Office Action
`dated January 7, 2010; Amendment
`and Response to Office Action dated
`April 7, 2010; Office Action dated June
`23, 2010; Response to Office Action
`dated October 25, 2010; Advisory
`Action dated November 24, 2010;
`Amendment and Response to Office
`Action dated November 29, 2010;
`Notice of Allowance dated April 1,
`2011.
`
`’066 Patent File History. Application
`No. 11/690,304, Continuation
`17
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 18 of 46 PageID #: 1506
`
`
`Plaintiffs’ Proposal
`
`
`
`Defendants’ Proposal
`Application filed on March 23, 2007;
`Office Action dated May 1, 2008;
`Amendment and Response to Office
`Action dated November 3, 2008;
`Office Action dated January 21, 2009;
`Amendment and Response to Office
`Action dated April 16, 2009; Advisory
`Action dated May 13, 2009; Request
`for Continued Examination dated
`February 1, 2010; Notice of Allowance
`dated July 22, 2010; Request for
`Continued Examination dated
`September 23, 2010; Office Action
`dated April 27, 2011; Amendment and
`Response to Office Action dated May
`19, 2011; Notice of Allowance dated
`August 5, 2011; Notice of Allowance
`dated November 17, 2011.
`
`’402 Patent File History. Application
`No. 13/323,322, Continuation
`Application filed on December 12,
`2011; Office Action dated May 4,
`2012; Response to Office Action dated
`November 2, 2012; Terminal
`Disclaimers dated November 2, 2012;
`Notice of Allowance dated January 16,
`2013.
`
`“wherein the breast cancer cells from the human subject have been found to
`have a 0 or 1+ score of ErbB2 protein expression by immunohistochemistry”
`(’834 Patent, claims 2, 5)
`
`
`Plaintiffs’ Proposal
`wherein the breast cancer cells from the
`human subject have been found to
`express ErbB2 protein at a 0 or 1+ level
`
`Defendants’ Proposal
`“wherein the breast cancer cells from
`the human subject have been found to
`express ErbB2 protein at a 0 or 1+
`
`18
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 19 of 46 PageID #: 1507
`
`
`Plaintiffs’ Proposal
`by immunohistochemistry
`
`
`Intrinsic Evidence:
`’834 Patent, including: 2:24-32; 3:24-
`3:27; 3:66-4:3; 7:24-45; 11:12-38;
`19:1-5.
`
`’834 Patent Prosecution File History,
`Application No. 11/942,449, including:
`Office Action (June 11, 2009);
`Response to Office Action (Sept. 11,
`2009); Office Action (Jan. 7, 2010);
`Office Action Response (Apr. 7, 2010);
`Office Action (June 23, 2010); Office
`Action Response (Oct. 25, 2010);
`Advisory Action (Nov. 24, 2010);
`Supplemental Response to Office
`Action After Notice of Appeal (Nov.
`29, 2010).
`
`Defendants’ Proposal
`level by any immunohistochemistry
`test”
`
`
`Intrinsic Evidence:
`
`
`’834 Patent, including: Claims 1-2;
`2:24-64; 3:7-14; 3:22-27; 3:42-4:25;
`4:15-43; 5:19-27; 5:46-6:4; 12:27-51;
`13:38-59; 15:34-43; 18:35-40; 18:57-
`22:41 (Examples 1-2 and Tables 1-9).
`
`Application No. 09/863,101 File
`History, Application No. 09/863,101,
`Original Application filed on May 18,
`2001; Office Action dated September
`25, 2002; Response to Office Action
`dated October 22, 2002; Office Action
`dated December 31, 2002; Amendment
`and Response to Office Action dated
`May 29, 2003; Office Action dated
`August 25, 2003; Notice of Appeal
`dated January 29, 2004; Amendment
`and Response to Office Action and
`RCE dated June 24, 2004; Office
`Action dated September 16, 2004;
`Examiner Interview Summary Record
`dated October 19, 2004; Amendment
`and Response to Office Action dated
`November 9, 2004; Office Action
`dated March 14, 2005; Amendment
`and Response to Office Action dated
`July 13, 2005; Office Action dated
`September 27, 2005; Amendment and
`Response to Office Action dated March
`27, 2006; Office Action dated June 20,
`2006; Abandonment dated June 27,
`2007.
`
`
`19
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 20 of 46 PageID #: 1508
`
`
`Plaintiffs’ Proposal
`
`Defendants’ Proposal
`Application No. 11/441,995 File
`History. Application No. 11/441,995,
`Divisional Application filed on May
`26, 2006; Office Action dated
`September 22, 2006; Response to
`Office Action dated October 23, 2006;
`Office Action dated January 16, 2007;
`Response to Office Action dated
`February 16, 2007; Office Action dated
`May 17, 2007; Abandonment dated
`December 28, 2007.
`
`’834 Patent File History. Application
`No. 11/942,449, Continuation
`Application filed on November 19,
`2007; Office Action dated June 11,
`2009; Response to Office Action dated
`September 11, 2009; Office Action
`dated January 7, 2010; Amendment
`and Response to Office Action dated
`April 7, 2010; Office Action dated June
`23, 2010; Response to Office Action
`dated October 25, 2010; Advisory
`Action dated November 24, 2010;
`Amendment and Response to Office
`Action dated November 29, 2010;
`Notice of Allowance dated April 1,
`2011.
`
`’066 Patent File History. Application
`No. 11/690,304, Continuation
`Application filed on March 23, 2007;
`Office Action dated May 1, 2008;
`Amendment and Response to Office
`Action dated November 3, 2008;
`Office Action dated January 21, 2009;
`Amendment and Response to Office
`Action dated April 16, 2009; Advisory
`Action dated May 13, 2009; Request
`20
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 21 of 46 PageID #: 1509
`
`
`Plaintiffs’ Proposal
`
`
`
`Defendants’ Proposal
`for Continued Examination dated
`February 1, 2010; Notice of Allowance
`dated July 22, 2010; Request for
`Continued Examination dated
`September 23, 2010; Office Action
`dated April 27, 2011; Amendment and
`Response to Office Action dated May
`19, 2011; Notice of Allowance dated
`August 5, 2011; Notice of Allowance
`dated November 17, 2011.
`
`’402 Patent File History. Application
`No. 13/323,322, Continuation
`Application filed on December 12,
`2011; Office Action dated May 4,
`2012; Response to Office Action dated
`November 2, 2012; Terminal
`Disclaimers dated November 2, 2012;
`Notice of Allowance dated January 16,
`2013.
`
`“wherein the patient’s cancer cells express HER2 at a 0 or 1+ level by
`immunohistochemistry”
`(’066 Patent, claims 2, 6)
`
`
`Plaintiffs’ Proposal
`
`wherein the patient’s cancer cells have
`an antigen level corresponding to a 0 or
`1+ score for HER2 by
`immunohistochemistry
`
`
`Intrinsic Evidence:
`
`’066 Patent, including: 3:24-3:27; 4:14-
`25; 22:22-24:4.
`
`
`Celltrion/Teva’s and Amgen’s
`Proposal
`“wherein the patient’s cancer cells
`have been found to express HER2 at a
`0 or 1+ level by any
`immunohistochemistry test”
`
`
`Intrinsic Evidence:
`
`
`’066 Patent, including: Claims 1 and
`3; 2:21-61; 3:7-13; 3:22-27; 3:42-
`4:29; 4:34-43; 5:19-27; 5:46-6:3;
`21
`
`

`

`Case 1:18-cv-01363-CFC Document 48 Filed 12/11/18 Page 22 of 46 PageID #: 1510
`
`
`Plaintiffs’ Proposal
`
`’066 Patent Prosecution File History,
`Application No. 11/690,304, including:
`Original Application Claims (Mar. 23,
`2007); Office Action (May 1, 2008);
`Response to Office Action (Nov. 3,
`2008); Office Action (Jan. 21, 2009);
`Office Action Response (Apr. 16, 2009);
`Advisory Office Action (May 13, 2009);
`Reasons for Allowance (July 22, 2009);
`Office Action (Apr. 27, 2011).
`
`
`Celltrion/Teva’s and Amgen’s
`Proposal
`12:25-48; 13:32-53; 15:24-33; 18:18-
`23; 18:40-22:20 (Examples 1-2 and
`Tables 1-9).
`
`Application No. 09/863,101 File
`History, Application No. 09/863,101,
`Original Application filed on May 18,
`2001; Office Action dated September
`25, 2002; Response to Office Action
`dated October 22, 2002; Office Action
`dated December 31, 2002;
`Amendment and Response to