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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`RIMFROST AS
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`Petitioner
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`v.
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`AKER BIOMARINE ANTARCTIC AS
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`Patent Owner
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`_______________________
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`Case: IPR2020-01532
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`U.S. Patent No. 9,644,169 B2
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`_______________________
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`DECLARATION OF DR STEPHEN J. TALLON
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`U.S. Patent No. 9,644,169 B2
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`TABLE OF CONTENTS
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`TABLE OF CONTENTS ........................................................................................... 2
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`AGREEMENT TO PROVIDE EXPERT TESTIMONY .......................................... 9
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`BASES FOR OPINIONS GIVEN ...........................................................................11
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`NO FINANCIAL INTEREST IN PROCEEDING ..................................................11
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`QUALIFICATIONS AND RELEVANT EXPERIENCE .......................................11
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`RELEVANT CONSIDERATIONS .........................................................................18
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`PRIORITY CLAIMS ...............................................................................................22
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`CHART I - FAMILY CHART ............................................................................23
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`Earlier PTAB Decisions Expressly Addressed All But Two Claim Limitations.
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` ..............................................................................................................................24
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`LEVEL OF ORDINARY SKILL IN THE ART & THE POSITA .........................26
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`THE ‘169 PATENT (EX1001) ................................................................................27
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`Krill Processing and Denaturation .......................................................................27
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`Extraction of Krill Components and Combining Krill Extracts ..........................29
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`Ether Phospholipids – Prior Art Krill Bill NKO Ether PL Content Greater than
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`3% ........................................................................................................................30
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`Examples 7 and 8 do not rely on the source or processing of the krill in the
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`extraction of krill oil. ...........................................................................................32
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`The ‘169 Patent Claims Summary. ......................................................................32
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`THE ‘169 PATENT IS ENTITLED TO A PRIORITY ..........................................36
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`MOTIVATION TO COMBINE - OVERVIEW .....................................................37
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`CHART II - SEVERAL KRILL COMPONENTS KNOWN TO A POSITA ....48
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`COMPARED WITH ‘169 PATENT EXAMPLE 7* ..........................................48
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`CLAIM TERMS ......................................................................................................53
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`ITC Claim Construction. ......................................................................................53
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`“krill oil” means “lipids extracted from krill” .....................................................57
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`“astaxanthin” means “the astaxanthin molecule having the structure shown
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`below and includes both cis- and trans forms of the molecule: ...........................63
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`“astaxanthin esters” means “astaxanthin molecules in which one or both of the
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`hydroxyl groups are replaced by a fatty acid tail connected to the astaxanthin
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`molecule through an ester bond.” ........................................................................68
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`“about” extends the number it modifies to include the range provided by
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`rounding, and means “a range about the number it modifies which when rounded
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`provides the number it modifies” .........................................................................69
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`“to denature lipases and phospholipases” means “to alter the conformational
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`structure of lipases and phospholipases to reduce lipid and phospholipid
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`decomposition” ....................................................................................................71
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`“freshly harvested krill” means “recently caught krill that has not significantly
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`degraded” .............................................................................................................75
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`“polar solvent” means “solvent or mixtures of solvents capable of extracting
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`polar lipids comprising phospholipids” ...............................................................77
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`“krill meal” means “processed krill, with reduced water content, from which
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`krill oil can be extracted.” ....................................................................................80
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`PRIOR ART .............................................................................................................91
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`Budziński (EX1008) ............................................................................................91
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`Catchpole (EX1009) ..........................................................................................100
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`Randolph (EX1011) ...........................................................................................114
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`Sampalis I (EX1012) ..........................................................................................120
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`Sampalis II (EX1013) ........................................................................................124
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`Breivik I (EX1035), Breivik II (EX1037) and Breivik III (EX1036) ...............134
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`Bunea (EX1020) ................................................................................................152
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`Bottino I (EX1007) ............................................................................................155
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`Bottino II (EX1038) ...........................................................................................158
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`Yoshitomi (EX1033) ..........................................................................................163
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`Fricke (EX1010) ................................................................................................171
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`Fricke discloses cooking of fresh krill to denature enzymes. ........................173
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`Fricke discloses storage of krill, including freshly cooked krill, followed by
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`extraction of krill oil. .....................................................................................175
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`Fricke discloses sterol, including cholesterol, content in krill oil. ................176
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`Fricke 1984 analysis of omega-3 fatty acids .................................................184
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`Enzymotec (EX1048, GRAS Notice No. GRN 000226) ...................................189
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`Tanaka (EX1015) ...............................................................................................200
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`Grantham (EX1032) ...........................................................................................204
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`Grynbaum (EX1039) .........................................................................................215
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`Mayzaud (EX1084) ............................................................................................223
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`Neptune Krill Oil (NKO) and Krill Bill NKO (EX1070, et. al) ........................225
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`Britton (EX1097) – trans (all-E) form of astaxanthin predominates in nature .230
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`Yuan (EX1098) ..................................................................................................233
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`Foss (EX1102) ...................................................................................................235
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`Higuera-Ciapara (EX1100) ................................................................................237
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`Lambertsen (EX1101) ........................................................................................241
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`Tehoharides (EX1030) .......................................................................................242
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`Hoem Presentation (EX1080) ............................................................................243
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`THE ‘169 PATENT CLAIM CHART ...................................................................247
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`‘169 PETITION GROUNDS ...............................................................................248
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`GROUND 1 ............................................................................................................249
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`BREIVIK II, CATCHPOLE, .................................................................................249
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`BUDZIŃSKI, FRICKE, RANDOLPH ..................................................................249
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`CLAIMS 1-5, 7-15, 17-20 .....................................................................................249
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`Claims 1, 2, 12 and 15. ......................................................................................249
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`Providing/Obtaining a Denatured Krill Product from Freshly Harvested Krill.
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` ........................................................................................................................251
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`Storing the Denatured Krill Product Before Extracting Krill Oil ..................252
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`Extracting Krill Oil from Stored Denatured Krill with a Polar Solvent ........254
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`Krill Oil with from about 3% to about 15% Ether Phospholipids. ................255
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`Astaxanthin Esters in Amount of greater than about 100 mg/kg Krill Oil. ...255
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`Claim 2. ..............................................................................................................257
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`Claims 3 and 13..................................................................................................258
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`Claim 4 and 14. ..................................................................................................259
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`Claims 5 and 15..................................................................................................261
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`Claims 7, 8, 17 and 18. ......................................................................................262
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`Claims 9 and 19..................................................................................................264
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`Claims 10 and 20................................................................................................266
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`Claim 11. ............................................................................................................267
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`Ground 1 Motivation and Claims 1-5, 7-15, 17-20 are Obvious. ......................269
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`GROUND 2 ............................................................................................................273
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`BREIVIK II, CATCHPOLE, .................................................................................273
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`BUDZIŃSKI, FRICKE, .........................................................................................273
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`RANDOLPH, SAMPALIS I ..................................................................................273
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`CLAIMS 6, 16 ........................................................................................................273
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`Ground 2 Motivation and Claims 6 and 16 are Obvious. ..................................274
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`CONCLUDING OPINION ....................................................................................276
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`APPENDIX A ........................................................................................................277
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`‘169 PATENT INVALDITY GROUNDS ............................................................277
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`‘169 PATENT CLAIM CHART ...........................................................................278
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`APPENDIX B ................................................................................................... 294
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`APPENDIX C ................................................................................................... 298
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`APPENDIX D ........................................................................................................300
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`APPENDIX E ........................................................................................................309
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`APPENDIX F .........................................................................................................316
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`I, Dr Stephen J. Tallon, do hereby make the following declaration:
`AGREEMENT TO PROVIDE EXPERT TESTIMONY
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`1.
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`I have agreed to provide expert testimony in support of Rimfrost AS’s
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`Petition for Inter Partes Review of U.S. Patent No. 9,644,169 B2. My Curriculum
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`Vitae is attached hereto as Appendix C.
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`2.
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`I understand that this proceeding involves U.S. Patent No. 9,644,169 B2
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`(“the ‘169 Patent”) entitled “Bioeffective Krill Oil Compositions,” (EX1001).
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`3.
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`I was asked to review and did review the chain of provisional applications
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`referred to in the ‘169 Patent (Exhibits 1002-1005) for disclosures relating to ether
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`phospholipids (ether PL), a material requirement of all the claims. I have reviewed
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`each of the Provisional Applications, Exhibits 1002-1005, to determine which if
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`any provide written support for any of the claim limitations (elements) of the ‘169
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`Patent which claim any of the various percentages of ether phospholipids by
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`weight of krill oil. Only one of the Provisional Applications disclose ether
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`phospholipids. In my opinion, none of the ‘446, ‘058 and ‘483 Provisional
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`Applications (Exhibits 1003-1005) mention the term ether phospholipid or
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`otherwise discuss or disclose the presence of ether phospholipids. In my opinion,
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`as discussed below, only the ‘072 Application provides any written description
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`regarding any percentage of ether phospholipids by weight of krill oil. The other
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`Provisional Applications, Exhibits 1003-1005, do not disclose or reference the
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`existence of ether phospholipids.
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`4.
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`I have been asked to provide my opinion regarding whether one of ordinary
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`skill in the art at the relevant time would have understood that certain prior art
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`references, alone or in combination, disclose or teach each of the elements and
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`limitations recited in the claims of the ‘169 Patent. I have also been asked to
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`provide my opinion regarding whether a person of ordinary skill in the art (a
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`“POSITA”) would have been motivated or had a rationale or reason to modify or
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`combine those certain prior art references to arrive at the elements recited in the
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`claims of the ‘169 Patent. In my opinion, as discussed below, the references
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`discussed below disclose or teach each of the elements and limitations recited in
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`the claims of the ‘169 Patent and a POSITA would have had a strong rationale and
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`motivation to combine them and would have done so without undue
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`experimentation and with a reasonable expectation of success.
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`BASES FOR OPINIONS GIVEN
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`5.
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`In forming my opinion, I have relied on my own education, work
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`experiences and knowledge and my review of the documents described herein and
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`listed in Appendix E, attached hereto.
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`NO FINANCIAL INTEREST IN PROCEEDING
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`6.
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`For my work related to this Inter Partes Review, my employer, Callaghan
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`Innovation, receives compensation for my time. I am not directly compensated by
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`either Hoffmann and Baron, LLP or the Petitioner. I have no financial interest in
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`this proceeding, and the potential for any future financial benefit is unaffected by
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`the content of my testimony or the outcome of this proceeding. My compensation
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`from my employer, Callaghan Innovation, is not in any way related to the outcome
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`of the case.
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`QUALIFICATIONS AND RELEVANT EXPERIENCE
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`7.
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`I am currently employed as Team Manager of the Processing Team within
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`the Integrated Bioactive Technologies Group of Callaghan Innovation, at the
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`Gracefield Research Centre in Lower Hutt, New Zealand (an agency of the
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`Government of New Zealand). The Integrated Bioactive Technologies group
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`specializes in near to market research and development in the field of processing of
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`biologically-derived raw materials to make high value nutraceuticals, food
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`ingredients and biopharmaceuticals. My research and expertise has helped to
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`enable a number of industries in New Zealand to make such products, including a
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`range of plant and marine derived extracts, including lipid extracts that are
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`produced using a supercritical fluid extraction process.
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`8.
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`Consequently, I have knowledge and expertise regarding methods of making
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`or extracting oils from crustaceans such as krill, including neutral and polar lipids,
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`and of their composition, including various extraction methods involving the use of
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`liquid and supercritical fluids, with and without polar co-solvents; and the polar
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`solvent extraction of marine biomasses to achieve the same aims. These
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`processing methods are now and were to a POSITA (see POSITA discussion
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`below) a matter of public knowledge. My CV is attached as Appendix C.
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`9.
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`I began developing supercritical CO2 + polar co-solvent extraction and
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`fractionation processes around 2003 with my colleague Dr Catchpole, and applied
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`them to biomasses containing phospholipids around 2004, and in particular to
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`marine and dairy biomasses. Around this time, I also investigated the use of
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`dimethyl ether (DME) for extracting phospholipids, again mainly from marine and
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`dairy biomasses.
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`10. Around this time, 2003-2004, Dr Andrew Mackenzie, also part of the
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`Integrated Bioactive Technologies group, developed an NMR-based method for
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`analyzing and quantifying phospholipids, based on the 31P isotope. This analysis
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`method was able to distinguish between very closely related phospholipids, such as
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`phosphatidylcholine (PC) and its ether-lipid analogue
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`alkylacylphosphatidylcholine (AAPC); and phosphatidylethanolamine (PE) and its
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`ether analogues phosphatidylethanolamine plasmalogen and
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`alkylacylphosphatidylethanolamine (AAPE).
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`11. Prior to the use of 31P NMR to determine the ether phospholipid content of
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`phospholipid lipids, and though other methods for analyzing same were available,
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`it was common industry practice to report only the total phospholipid content for
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`the phosphatidylcholine (PC) and phosphatidylethanolamine (PE) lipid
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`components. Thus, when the amount of the PC lipid component was reported, the
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`number reported included not only PC, but its ether-lipid analogue
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`alkylacylphosphatidylcholine (AAPC). The total then reported being the sum of the
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`non-ether phospholipids and ether phospholipids. In a like manner, when the
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`amount of the phosphatidylethanolamine (PE) component was reported, the
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`number reported included not only PE, but its ether analogues
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`phosphatidylethanolamine plasmalogen (PE plasmalogen) and
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`alkylacylphosphatidylethanolamine (AAPE) as well.
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`12. When the industry began to accept the 31P NMR standard for the first time
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`the ether-phospholipid components started to be consistently reported as separate
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`constituents.
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`13.
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`In 2006 the Integrated Bioactive Technologies group of Callaghan
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`Innovation (of which I am a part), began to work collaboratively with Nutrizeal
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`Ltd (founded 1995), now operating as Pharmalink Extracts, Ltd. (Nelson, New
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`Zealand) on the extraction of dry krill powder to produce krill lipid extracts
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`enriched in phospholipids, and to provide a detailed compositional analysis of
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`those natural extracts.
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`14. The work of the Integrated Bioactive Technologies group on the extraction
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`of phospholipids using CO2 and CO2+ polar co-solvent led us to discover that we
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`could separate different types of phospholipids based on their solubility. Work was
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`performed on a variety of biomasses including krill, which demonstrated that a
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`phospholipid-rich extract containing both ether and non-ether phospholipids was
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`obtained. This work is described in WO 2007/123424, published November 2007,
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`based on International Application Number PCT/NZ/2007/000087, Catchpole and
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`Tallon, International Filing Date April 20, 2007 (Catchpole, Example 18 and Table
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`16, p. 24, EX1009, p. 0024).
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`15. The 31P-NMR analysis method used in Catchpole (pp. 14 & 24, EX1009, pp.
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`0014 & 0024) demonstrated that ether phospholipids were an intrinsic constituent
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`of the lipid composition of many marine organisms, including krill and krill meal
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`and provided a direct determination of the amounts of ether phospholipids present.
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`16. We also performed lipid analysis work on existing commercial krill lipid
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`products that were supplied to us by Nutrizeal in 2006. Upon information and
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`belief, these products were Neptune Krill Oil (NKO), a.k.a. “Krill Bill”, with the
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`krill oil in the form of gelatine capsules as taken from a Krill Bill bottle shown
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`below (see EX1069); and Aquasource Krill Oil (Antarctica Select), again with the
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`krill oil in the form of gelatine capsules (see EX1071 for 2006 online Aquasource
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`Antarctica Krill Oil disclosures). In 2006, the product specification for Krill Bill
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`krill oil disclosed that the krill oil contained greater than 40% phospholipids and
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`greater than 1500 mg/kg astaxanthin esters. See EX1070 (see EX1076 from
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`Internet Archive regarding contents of EX1070 and EX1071).
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`17. The encapsulated krill oils were analyzed and found to contain, among the
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`phospholipids, both non-ether phospholipids and ether phospholipids, and high
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`levels of omega-3 fatty acids (polyunsaturated fatty acids which have an
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`unsaturated bond at the third carbon from the terminal end, commonly reported as
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`ω-3, n-3, or omega-3) including eicosapentaenoic acid (EPA) and docosahexaenoic
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`acid (DHA) attached to the phospholipids.
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`18.
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`Individuals from Industrial Research Limited, New Zealand (IRL, now
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`known as Callaghan Innovation, New Zealand), developed methods of extracting
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`krill oil from krill and analyzing the resulting krill oil product during the period of
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`at least 2003-2006. The extraction methods used involved CO2 extraction with and
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`without a polar entrainer. These extraction and analysis methods were later used in
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`performing work for a third party. The work included the results reported in the
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`‘169 Patent in Tables 22 and 23, and in the text of the patent (see, e.g., ‘169 Patent,
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`Example 8, 32:60-33:47, EX1001, pp. 0041-0042), pertaining to, among other
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`things, the ether phospholipids in krill oil extracts, and providing the only support
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`for ether phospholipids in the ‘169 Patent. Additional results are reported in the
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`‘072 Provisional Application. See, e.g., ‘072 Provisional Application, pp. 44-52,
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`EX1002, pp. 0047-0055.
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`19. The ‘169 Patent does not identify individuals at IRL who conceived and
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`developed this work as inventors of the ‘169 Patent, even though all the claims
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`require that the krill oil compositions have an ether phospholipid component, a
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`component whose presence the applicants for the ‘169 Patent argued, in the patent
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`application for the related patent U.S. 9,644,170 (‘170 Patent, EX1093,
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`distinguished it from the prior art NKO krill oil product.1 The relationship
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`between the ‘170 Patent and the ‘169 Patent is diagrammed in Chart I below. The
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`‘170 Patent and the ‘169 Patent are continuations of the U.S. Patent No. 9,375,453
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`B2 (the ‘453 Patent, EX1067).
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`20. By 2006 and even before, EPA, DHA and phospholipids were associated
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`with beneficial health and were recognized to be important compounds for use in
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`the nutraceutical industry and they remain so today. See, e.g., Aquasource
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`Antarctica Select Krill Oil published literature from 2006 shown in EX1071.
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`21. Since 2006 I have continued to work with, among other things, krill and krill
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`oils, including analysis of the components, development of extraction processes for
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`further fractionation of the components, and product concepts thereof.
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`1 See “Response to Office Action”, October 12, 2016, ‘170 Patent File History,
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`Exhibit 1063, pp. 0438-0447, see p. 0446. See also, “Applicant-Initiated Interview
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`Summary”, October 20, 2016, ‘170 Patent File History, Exhibit 1063, pp. 0582-
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`0584.
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`RELEVANT CONSIDERATIONS
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`22.
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`23.
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`I provide my opinions in this declaration as informed below.
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`I have been informed that to be entitled to an earlier priority date each claim
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`limitation must be expressly, implicitly, or inherently supported in the originally
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`filed disclosure, in this case in the Provisional Applications Exhibits 1002-1005.
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`24.
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`I have been informed that to benefit from a claim of priority to an originally
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`filed disclosure, the originally filed disclosure must contain a written description of
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`the invention as claimed in the later application (the ‘169 Patent), and of the
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`manner and process of making and using it, in such full, clear, concise, and exact
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`terms as to enable any person of ordinary skill in the art to make and use the
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`invention as claimed. I have been informed that to meet this requirement, the
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`originally filed disclosure must reasonably convey to one of skill in the art that the
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`inventor possessed the later-claimed subject matter at the time the parent
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`application was filed. I have been further informed, a disclosure in a parent
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`application (the originally filed disclosure) that merely renders the later-claimed
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`invention obvious is not sufficient to meet the written description requirement; the
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`disclosure itself must describe the claimed invention with all its limitations.
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`25.
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`I have been further informed that to determine if the later application, that is,
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`the ‘169 Patent, is to receive the benefit of an earlier filed application or patent is
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`whether a person of ordinary skill in the art would recognize that the applicant
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`possessed what is claimed in the later filed application as of the filing date of the
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`earlier filed application or patent. The disclosure as originally filed in the earlier
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`applications or patent must convey with reasonable clarity to those skilled in the art
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`that the inventor was in possession of the invention. That is, one skilled in the art,
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`reading the original disclosure, must immediately discern the limitation at issue in
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`the claims.
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`26.
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`I have been informed that these requirements for written support, possession
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`of the invention and enablement, are referred to as § 112(a) requirements. I have
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`further been informed that if a patent’s claims do not have § 112(a) support, it is
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`unpatentable and invalid.
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`27.
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`I have been informed that a claimed invention is unpatentable if the
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`differences between the invention and the prior art are such that the subject matter
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`as a whole would have been obvious at the time the alleged invention was made to
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`a person having ordinary skill in the art to which the subject matter pertains. I
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`have also been informed that an obviousness analysis takes into account factual
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`inquiries including the level of a person of ordinary skill in the art, the scope and
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`content of the prior art, and the differences between the prior art and the claimed
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`subject matter.
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`28.
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`I have been informed that there are several accepted rationales for
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`combining references or modifying a reference to show obviousness of the claimed
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`subject matter. Some of these rationales include the following: combining prior art
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`elements according to known methods to yield predictable results; simple
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`substitution of one known element for another to obtain predictable results; a
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`predictable use of prior art elements according to their established functions;
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`applying a known technique to a known device to yield predictable results;
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`choosing from a finite number of identified, predictable solutions, with a
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`reasonable expectation of success; and some teaching, suggestion, or motivation in
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`the prior art that would have led one of ordinary skill to modify the prior art
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`reference or to combine prior art reference teachings to arrive at the claimed
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`invention.
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`29.
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`I have been informed that “a person of ordinary skill in the art”, a POSITA,
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`is not a specific, real individual, but rather a hypothetical individual or team of
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`individuals working closely together, who is presumed to have known the relevant
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`art at the time of the invention. In defining the POSITA, I have been informed to
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`consider factors such as the educational level and years of experience not only of
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`the person or persons who have developed the invention that is the subject of the
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`case, but also others working in the pertinent art at the time of the invention; the
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`types of problems encountered in the art; the teachings of the prior art; patents and
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`publications of other persons or companies; and the sophistication of the
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`technology.
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`30.
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`I have been informed that claim terms are interpreted according to their
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`broadest reasonable construction in light of the specification of the ‘169 Patent in
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`which they appear and that the patent claim terms are also given their ordinary and
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`customary meaning as would be understood by a POSITA in the context of the
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`entire disclosure.
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`PRIORITY CLAIMS
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`31. As I have been informed the ‘169 Patent states that it is a continuation of
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`application No. 14/020,162 (EX1055), now U.S. Patent No. 9,375,453 (EX1067),
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`which is a continuation of application No. 12/057,755 (EX1024), now U.S. Patent
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`No. 9,034,388 B2 (“the ‘388 Patent”, EX1047), which claims the benefit of
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`expired U.S. Provisional Application No. 60/920,483, filed on March 28, 2007
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`(“the ‘483 Provisional Application”, EX1005), U.S. Provisional Application No.
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`60/975,058, filed on September 25, 2007 (“the ‘058 Provisional Application”,
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`EX1004), U.S. Provisional Application No. 60/983,446, filed on October 29, 2007
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`(“the ‘446 Provisional Application”, EX1003), and U.S. Provisional Application
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`No. 61/024,072, filed on January 28, 2008 (“the ‘072 Provisional Application”,
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`EX1002).
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`32.
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`I have been provided with the following Chart I. I note that I have been
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`involved as an expert on behalf of Petitioner in all of the inter partes reviews
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`referenced in Chart I.
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`CHART I - FAMILY CHART
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`
`
`U.S. Provisional
` Patent Application
` No. 60/920,483,
` filed Mar. 28, 2007
` (EX1005)
`
`U.S. Provisional
` Patent Application
` No. 60/975,058,
`filed Sep. 25, 2007
` (EX1004)
`
`U.S. Provisional
` Patent Application
` No. 60/983,446,
`filed Oct. 29, 2007
` (EX1003)
`
`U.S. Provisional Patent
`Appl’n No. 61/024,072,
`filed Jan. 28, 2008
`(EX1002)
`[First mention of ether
`phospholipids]
`
`
`CONTINUATION
`U.S. Patent Application, Ser. No. 12/057,775, filed Mar. 28, 2008 (EX1024),
` U.S. Patent Appl’ Pub. No. , US2008/0274203 A1, published November 6, 2008 (EX1043),
`now U.S. Patent No. 9,034,388, issued May 19, 2015 (EX1047)
`
`
`
`CONTINUATION
`9,078,905
`(EX1116)
`IPR2017-00745
`FWD (EX1103)
`Cancelled
`EX1156
`
`
`CON