UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioner
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner
`
`____________________
`
`Inter Partes Review No.: Unassigned
`____________________
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`DECLARATION OF M. JAYNE LAWRENCE, PH.D
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`
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`1
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`LUPIN EX 1005
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`Page 1 of 243
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`SENJU EXHIBIT 2088
`INNOPHARMA v. SENJU
`IPR2015-00903
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`

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`VI.
`
`Contents
`I.
`INTRODUCTION ................................................................................................................. 6
`II.
`QUALIFICATIONS .............................................................................................................. 6
`III. MATERIALS REVIEWED ................................................................................................ 11
`LEGAL STANDARDS ....................................................................................................... 11
`IV.
`V.
`SUMMARY OF OPINIONS ............................................................................................... 18
`A. Claims 1-30 of U.S. Patent No. 8,669,290 are invalid as obvious ................................ 18
`B. Claims 1-30 of U.S. Patent No. 8,754,131 are invalid as obvious ................................ 20
`C. Claims 1-27 of U.S. Patent No. 8,871,813 are invalid as obvious ................................ 22
`D. Claims 1-30 of U.S. Patent No. 8,927,606 are invalid as obvious ................................ 23
`AQUEOUS FORMULATION DEVELOPMENT FOR OPHTHALMIC USE ................. 25
`A. General approach to formulation development ............................................................. 25
`B. NSAIDs were known and approved for ophthalmic use ............................................... 28
`C. Formulation strategies for NSAIDs ............................................................................... 33
`D. Formulation strategies for bromfenac ........................................................................... 37
`VII. DETAILED DESCRIPTION OF THE PRIOR ART .......................................................... 39
`A. The ‘225 patent –U.S. Patent No. 4,910,225 (EX 1010) ............................................... 39
`B. EP ‘984 – EP 0 306 984 A1 (EX 1014) ........................................................................ 40
`C. The ‘913 patent –U.S. Patent No. 5,891,913 (EX 1021) ............................................... 43
`VIII. DETAILED OPINIONS ...................................................................................................... 45
`A. U.S. Patent No. 8,669,290 ............................................................................................. 45
`1. Level of Skill in the Art ..................................................................................... 45
`2. Claim Construction ............................................................................................ 45
`3. Claims 1–30 of the ’290 Patent ......................................................................... 45
`4. The Specification of the ’290 Patent ................................................................. 48
`5. Summary of the Prosecution History of the ’290 Patent ................................... 49
`6. All Claims of the ‘290 Patent are Obvious Over the ‘225 Patent in View
`of EP ‘984 .......................................................................................................... 51
`a. Independent Claim 1 ................................................................................... 52
`b. Independent Claim 8 ................................................................................... 56
`c. Independent Claim 14 ................................................................................. 58
`d. Stability (claims 10, 20, and 22) .................................................................. 59
`e. Pharmacologically Acceptable Salts (claims 2, 3, 9, 15, 16, and 21) ......... 62
`2
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`f. pH (claims 6, 12, 18, and 24) ...................................................................... 64
`g. Concentration of Components (claims 4, 5, 7, 11, 13, 17, 19, 23,
`and 25) ......................................................................................................... 65
`h. Preservative Efficacy Standard (claims 26-30) ........................................... 72
`7. All Claims of the ‘290 Patent are Obvious Over the ‘913 Patent in View
`of The ‘225 Patent ............................................................................................. 76
`a. Independent Claim 1 ................................................................................... 76
`b. Independent Claim 8 ................................................................................... 78
`c. Independent Claim 14 ................................................................................. 80
`d. Stability (claims 10, 20, and 22) .................................................................. 81
`e. Pharmacologically Acceptable Salts (claims 2, 3, 9, 15, 16, and 21) ......... 83
`f. pH (claims 6, 12, 18, and 24) ...................................................................... 84
`g. Concentration of Components (claims 4, 5, 7, 11, 13, 17, 19, 23,
`and 25) ......................................................................................................... 86
`h. Preservative Efficacy Standard (claims 26-30) ........................................... 91
`8. Objective Indicia of Nonobviousness ................................................................ 93
`a. Other Objective Indicia ............................................................................. 101
`B. U.S. Patent No. 8,754,131 ........................................................................................... 104
`1. Level of Skill in the Art ................................................................................... 104
`2. Claim Construction .......................................................................................... 104
`3. Claims 1-30 of the ’131 Patent ........................................................................ 104
`4. The Specification of the ’131 Patent ............................................................... 107
`5. Summary of the Prosecution History of the ’131 Patent ................................. 108
`6. All Claims of the ‘131 Patent are Obvious Over the ‘225 Patent in View
`of EP ‘984 ........................................................................................................ 108
`a. Independent claims (claims 1, 7, and 13) .................................................. 108
`b. Stability (claims 9, 19, and 21) .................................................................. 115
`c. Pharmacologically Acceptable Salts (claims 2, 3, 8, 14, 15, and 20) ....... 117
`d. pH (claims 5, 11, 17, and 23) .................................................................... 119
`e. Concentration of Components (claims 4, 6, 10, 12, 16, 18, 22, and
`24) .............................................................................................................. 121
`f. Preservative Efficacy Standard of US Pharmacopoeia (claims 25 –
`29) .............................................................................................................. 126
`g. Formulation Additives (claim 30) ............................................................. 129
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`3
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`7. All Claims of the ‘131 Patent are Obvious Over the ‘913 Patent in View
`of The ‘225 Patent ........................................................................................... 130
`a. Independent Claims (claims 1, 7, and 13) ................................................. 130
`b. Stability (claims 9, 19, and 21) .................................................................. 135
`c. Pharmacologically Acceptable Salts (claims 2, 3, 8, 14, 15, and 20) ....... 138
`d. pH (claims 5, 11, 17, and 23) .................................................................... 140
`e. Concentration of Components (claims 4, 6, 10, 12, 16, 18, 22, and
`24) .............................................................................................................. 141
`f. Preservative Efficacy Standard of US Pharmacopoeia (claims 25 –
`29) .............................................................................................................. 145
`g. Formulation Additives (claim 30) ............................................................. 146
`8. Objective Indicia of Nonobviousness .............................................................. 147
`C. U.S. Patent No. 8,871,813 ........................................................................................... 150
`1. Level of Skill in the Art ................................................................................... 150
`2. Claim Construction .......................................................................................... 150
`3. Claims 1-27 of the ’813 Patent ........................................................................ 150
`4. The Specification of the ’813 Patent ............................................................... 154
`5. Summary of the Prosecution History of the ’813 Patent ................................. 154
`6. All Claims of the ‘813 Patent are Obvious Over the ‘225 Patent in View
`of EP ‘984 ........................................................................................................ 155
`a. Independent Claims (claims 1, 7, and 13) ................................................. 155
`b. Stability (claims 9, 19, and 20) .................................................................. 162
`c. Pharmacologically Acceptable Salts (claims 2, 3, 8, 14, and 15) ............. 165
`d. pH (claims 5, 11, 17, and 22) .................................................................... 166
`e. Concentration of Components (claims 4, 6, 10, 12, 16, 18, 21, and
`23) .............................................................................................................. 168
`f. No Preservatives (claims 24 – 26) ............................................................. 174
`g. Formulation Additives (claim 27) ............................................................. 175
`7. All Claims of the ‘813 Patent are Obvious Over the ‘913 Patent in View
`of The ‘225 Patent ........................................................................................... 176
`a. Independent Claims (claims 1, 7, and 13) ................................................. 176
`b. Stability (claims 9, 19, and 20) .................................................................. 182
`c. Pharmacologically Acceptable Salts (claims 2, 3, 8, 14, and 15) ............. 184
`d. pH (claims 5, 11, 17, and 22) .................................................................... 186
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`4
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`e. Concentration of Components (claims 4, 6, 10, 12, 16, 18, 21, and
`23) .............................................................................................................. 187
`f. No Preservatives (claims 24 – 26) ............................................................. 192
`g. Formulation Additives (claim 27) ............................................................. 193
`8. Objective Indicia of Nonobviousness .............................................................. 193
`D. U.S. Patent No. 8,927,606 ........................................................................................... 196
`1. Level of Skill in the Art ................................................................................... 196
`2. Claim Construction .......................................................................................... 196
`3. Claims 1-30 of the ’606 Patent ........................................................................ 196
`4. The Specification of the ’606 Patent ............................................................... 200
`5. Summary of the Prosecution History of the ’606 Patent ................................. 200
`6. All Claims of the ‘606 Patent are Obvious Over the ‘225 Patent in View
`of EP ‘984 ........................................................................................................ 201
`a. Independent Claims (claims 1, 11, and 19) ............................................... 201
`b. Disease Indications (claims 2, 3, 13, 14, 20, and 21) ................................ 208
`c. Dosage Information (claim 10) ................................................................. 210
`d. Stability (claims 12 and 26) ....................................................................... 211
`e. Pharmacologically Acceptable Salts (claims 4, 7, 17, and 22) ................. 213
`f. Concentration of Components (claims 5, 6, 8, 9, 15, 16, 18, 23, 24,
`25, and 27) ................................................................................................. 215
`g. Preservative Efficacy Standard of EP-criteria B (claims 28 – 30) ............ 221
`7. All Claims of the ‘606 Patent are Obvious Over the ‘913 Patent in View
`of The ‘225 Patent ........................................................................................... 224
`a. Independent Claims (claims 1, 11, and 19) ............................................... 224
`b. Disease Indications (claims 2, 3, 13, 14, 20, and 21) ................................ 228
`c. Dosage Information (claim 10) ................................................................. 230
`d. Stability (claims 12 and 26) ....................................................................... 230
`e. Pharmacologically Acceptable Salts (claims 4, 7, 17, and 22) ................. 232
`f. Concentration of Components (dependent claims 5, 6, 8, 9, 15, 16,
`18, 23, 24, 25, and 27) ............................................................................... 234
`g. Preservative Efficacy Standard of EP-criteria B (claims 28 – 30) ............ 240
`8. Objective Indicia of Nonobviousness .............................................................. 241
`
`5
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`
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`I, Jayne Lawrence, Ph.D., declare and state as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I am over the age of eighteen (18) and otherwise competent to make
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`this declaration.
`
`2.
`
`I have been retained as an expert witness on behalf of Lupin Ltd. and
`
`Lupin Pharmaceuticals Inc. for the above captioned inter partes review (“IPR”). I
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`am being compensated for my time in connection with this IPR at my standard
`
`consulting rate, which is GBP300 per hour. My compensation is not contingent on
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`the conclusions I reach herein or on the specifics of my testimony. I have no
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`financial stake in the outcome of this proceeding.
`
`
`
`II. QUALIFICATIONS
`
`3.
`
`I am an expert in the field of formulation and drug delivery,
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`specifically pharmaceutical formulation for oral and parenteral use (i.e., non-oral,
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`including intravenous intramuscular, nasal, respiratory and ophthalmic), including
`
`aqueous liquid preparations. I have been an expert in this field since prior to 2003.
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`In formulating my opinions, I have relied upon my training, knowledge, and
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`experience in the relevant art. A copy of my current curriculum vitae is provided as
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`Exhibit 1054, and it provides a comprehensive description of my academic and
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`employment history.
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`4.
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`As an expert in the relevant field since prior to 2003, I am qualified to
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`provide an opinion as to what a POSA would have understood, known, or
`
`concluded as of 2003. Since 1984, I have accumulated significant training and
`
`experience in the relevant field and related fields.
`
`5.
`
`I received a BSc with first class (top) honors from Liverpool
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`Polytechnic in 1981, and a Ph.D. in Pharmacy from Manchester University in 1985.
`
`The subject of my PhD studies was the design, synthesis and physic-chemical
`
`characterization of novel non-ionic surfactants for use in aqueous pharmaceutical
`
`formulations. I performed my PhD studies under the supervision of Professors P.H.
`
`Elworthy and D. Attwood.
`
`6.
`
`From 1984 to the present time I have held full-time, tenured academic
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`positions of increasing seniority in Pharmacy (Lecturer 1984-1997, Senior Lecturer
`
`1997-1999), Drug Delivery (Reader 2000-2003) and, most recently Biophysical
`
`Pharmaceutics (Professor 2003-to date) at King’s College London. I note that my
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`professorship at King’s College London is the United Kingdom equivalent of a full,
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`tenured Professorship in a university in the United States. In 1993 I spent a 6
`
`month sabbatical working in Respiratory Product Development in Glaxo Group
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`Research (now GSK) concerned with the potential use of surfactants in the new
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`propellant formulations.
`
`7.
`
`I am currently Head of the Pharmaceutical Biophysics Group of The
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`Institute of Pharmaceutical Science, King’s College London and I have held this
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`
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`position since 2002. The Pharmaceutical Biophysics Group of The Institute of
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`Pharmaceutical Science, King’s College London currently consists of 6 academics
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`and associated post-doctoral fellows and PhD students. The work of the group is
`
`concerned with securing an understanding at the molecular level of the
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`physicochemical and biological properties of drug and gene delivery systems,
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`through the combined application of advanced analytical techniques.
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`8.
`
`Since 2007, I have also held the role of Chief Scientist at the Royal
`
`Pharmaceutical Society on a part-time secondment from King’s College London.
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`At the present time, I equally divide my time between these two roles. My role at
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`the Royal Pharmaceutical Society involves me representing it at the highest levels
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`to outside organisations and key stakeholders (including government and public
`
`bodies), acting as its spokesperson on pharmaceutical sciences in the media and
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`ensuring high quality pharmaceutical science input to policy development and
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`implementation.
`
`9. My past and current research has been in relation to pharmaceutical
`
`formulation and drug/gene delivery. I have been a principal or co-investigator on
`
`many formulation and drug/gene delivery studies, recent examples of which
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`include the development of novel microemulsions for parenteral delivery, including
`
`for ocular administration; synthesis and characterisation of novel, non-ionic and
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`zwitterionic surfactants with enhanced drug solubilisation capacity; the
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`development of novel polymeric surfactants for pulmonary delivery; nanoparticles
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`for the targeted delivery of therapeutic agents to the brain; and development of new
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`injectable composites for gene delivery.
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`10.
`
`I have co-authored over 120 full scientific publications, with numerous
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`conference papers and other scientific outputs such as articles for the scientific
`
`magazines. I have given over 150 invited (national and international) presentations.
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`I have also been involved in the organisation of many pharmaceutical science
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`meetings and conferences including the annual Academy of Pharmaceutical
`
`Sciences conference.
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`11. As listed in my curriculum vitae, I have also received numerous
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`awards pertaining to my research and teaching. For example, in 2013 I became a
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`Faculty Fellow of the Royal Pharmaceutical Society (“FFRPS”), while in 2012 I
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`was awarded an Eminent Fellowship of the Royal Pharmaceutical Society
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`(“EFAPS”), one of only 20 such Fellowships.
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`12.
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`I currently hold senior positions in a number of national and
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`international scientific committees, including the Academy of Pharmaceutical
`
`Sciences of Great Britain where I am currently vice-chair and the Formulation and
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`Pharmaceutical Technology Special Interest Group of the International
`
`Pharmaceutical Federation where I am vice-chair but will become chair next year.
`
`13.
`
`In addition to gaining expertise through educational training,
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`professional experiences, and research experiences described above, I have kept
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`abreast of the field of drug/gene delivery and formulation, particularly of aqueous
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`liquid preparations, by reading scientific literature, attending or presenting at
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`scientific conferences, and attending or presenting at academic symposia. I have
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`also been invited to participate in the peer review process for various scientific
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`journals, and have reviewed many manuscripts submitted by other scientists
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`relating to drug delivery, including ocular delivery. Some of the scientific journals
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`for which I have reviewed scientific manuscripts include: International Journal of
`
`Pharmaceutics, Journal of Pharmaceutical Science, Langmuir, and Biochim.
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`Biophys. Acta. Furthermore, I have collaborated with, or have communicated with,
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`many researchers in the field of formulation and drug/gene delivery. Accordingly, I
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`am an expert in the field of formulation and drug/gene delivery.
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`14.
`
`I have been retained by counsel for Lupin to provide an expert
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`declaration in this action.
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`15. As set forth in more detail below, the patents at issue here, U.S. Patent
`
`Nos. 8,669,290; 8,754,131; 8,871,813; and 8,927,606 (collectively referred to
`
`herein as “the subject patents”), relate generally to an aqueous formulation for
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`ophthalmic use containing bromfenac and tyloxapol, and the method of treating an
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`inflammatory disease of an eye using the same aqueous formulation. Similar to the
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`patents at issue, my previous research and industry experience focused on the
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`design and formulation of aqueous formulations including, for example, novel
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`surfactant and polymer containing formulations for parenteral (including ocular)
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`delivery. The opinions and conclusions I express in this declaration are based on
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`my education, my extensive experience in this field, and my review of the materials
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`related to this matter.
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`
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`
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`III. MATERIALS REVIEWED
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`16.
`
`In forming my opinions, I have reviewed, among other things, U.S.
`
`Patent 8,669,290 (“the ’290 patent”), U.S. Patent 8,754,131 (“the ‘131 patent”),
`
`U.S. Patent 8,871,813 (“the ‘813 patent”), U.S. Patent 8,927,606 (“the ‘606
`
`patent”), and papers filed in the Patent Office in connection with prosecution of
`
`each of these patents, which I understand to constitute the prosecution histories of
`
`the patents. A full list of materials I have considered can be found in Appendix B.
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`
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`IV. LEGAL STANDARDS
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`17.
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`In this section I describe my understanding of certain legal standards. I
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`have been informed of these legal standards by Petitioner’s attorneys. I am not an
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`attorney, and I am relying only on instructions from Petitioner’s attorneys for these
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`legal standards. I have applied these understandings in my analysis as detailed
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`below.
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`18.
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`I understand that in order to receive a patent an inventor must invent
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`or discover a new and useful process, machine, manufacture, or composition of
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`matter.
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`19.
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`I understand that patent protection may be granted for any new and
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`useful process, machine, manufacture, or composition of matter, or any new and
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`useful improvement thereof.
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`20. With respect to the level of ordinary skill in the art at the relevant
`
`times applicable to the subject patents, I understand that factors such as the
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`education level of those working in the field, the sophistication of the technology,
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`the types of problems encountered in the art, the prior art solutions to those
`
`problems, and the speed at which innovations are made may help establish the level
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`of skill in the art. One with ordinary skill has the ability to understand the
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`technology and make modest adaptations or advances. A person of ordinary skill in
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`the art is also a person of ordinary creativity, not an automaton.
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`21.
`
`In my opinion, a person of ordinary skill in the art (“POSA”) at the
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`time of the alleged invention described in the subject patents would have been a
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`pharmaceutical scientist involved in the research and development of
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`pharmaceuticals, and would have a Ph.D. and several years of experience in the
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`field. The amount of post-graduate level experience would depend upon the level of
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`formal education and particular experience in the field.
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`22.
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`In determining the qualifications of a POSA I considered, among other
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`factors, the field of the alleged invention and use thereof described in the subject
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`patents, and my experience with the educational level of practitioners in the fields
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`of drug/gene formulation, pharmacy, drug/gene delivery, analytical chemistry,
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`organic chemistry, or chemical engineering. In addition, my opinion is based upon
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`my background, education, and personal experience devoted to the fields of
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`pharmaceutical development.
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`23.
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`I consider myself to be an expert in the art of the subject patents at the
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`time of the alleged inventions claimed therein.
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`24.
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`I understand that the first step in comparing prior art to patent claims
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`is to properly construe the claims to determine claim scope and meaning. I
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`understand that in Inter Partes Review proceedings the claim terms are presumed
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`to take on their ordinary and customary meaning based on the broadest reasonable
`
`interpretation of the claim language.
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`25.
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`I understand that a patent or other publication must first qualify as
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`prior art before it can be used to invalidate a patent claim. I understand that
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`documents and materials that qualify as prior art can be used to render a claim
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`unpatentable as anticipated under 35 U.S.C. § 102 or as obvious under 35 U.S.C. §
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`103.
`
`26.
`
`I understand that the “priority date” of a patent is taken to be the date
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`on which it is filed. I further understand that the “critical date” for a patent is one
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`year prior to its effective filing date. It is my understanding that the critical date is
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`significant because published information prior to the critical date is prior art that
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`can render a patent claim unpatentable regardless of the purported date of
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`invention.
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`27.
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`I understand that claim terms are given their ordinary and customary
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`meaning, as understood by a POSA in the context of the entire disclosure of the
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`specification. I also understand that if an inventor acts as his or her own
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`lexicographer, the definition must be set forth in the specification with reasonable
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`clarity, deliberateness, and precision.
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`28.
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`I understand that, once the claims of a patent have been properly
`
`construed, the second step in determining anticipation of a patent claim requires a
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`comparison of the properly construed claim language to the prior art on a
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`limitation-by-limitation basis.
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`29.
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`I understand that a prior art reference “anticipates” a claim, and thus
`
`renders the claim unpatentable, if all elements of the claim are disclosed in that
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`prior art reference, either explicitly or inherently (i.e., necessarily present or
`
`implied).
`
`30.
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`I understand that a claim is unpatentable under 35 U.S.C. § 102(b) of
`
`the Patent Act if the invention was patented or published anywhere, or was in
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`public use, on sale, or offered for sale in this country, more than one year prior to
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`the filing date of the patent application. I understand that a U.S. or foreign patent
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`qualifies as prior art under § 102(b) to a patent claim if the date of issuance of the
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`patent is more than one year before the filing date of the patent claim. I further
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`understand that a printed publication, such as an article published in a magazine or
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`trade publication or a U.S. or foreign patent application, also qualifies as prior art
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`under § 102(b) to a patent claim if the publication occurs more than one year before
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`the filing date of the patent.
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`31.
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`I have been instructed by counsel on the law regarding obviousness,
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`and understand that even if a patent is not anticipated, it will be unpatentable if the
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`differences between the claimed subject matter and the prior art are such that the
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`subject matter as a whole would have been obvious at the time the invention was
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`made to a person of ordinary skill in the pertinent art.
`
`32.
`
`I have been instructed by counsel that the “time of the invention” for
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`the purposes of the ’290 patent is January 21, 2003. I also have been instructed that
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`the “critical date” is January 16, 2003. In my analyses below, I consider the
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`ordinarily skilled artisan’s understanding as of January 21, 2003, but confirm that
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`my opinions remain the same even if applying the January 16, 2003 date.
`
`33.
`
`I have been instructed by counsel that the “time of the invention” for
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`the purposes of the ’131 patent is January 21, 2003. I also have been instructed that
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`the “critical date” is January 16, 2003. In my analyses below, I consider the
`
`ordinarily skilled artisan’s understanding as of January 21, 2003, but confirm that
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`my opinions remain the same even if applying the January 16, 2003 date.
`
`34.
`
`I have been instructed by counsel that the “time of the invention” for
`
`the purposes of the ’813 patent is January 21, 2003. I also have been instructed that
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`the “critical date” is January 16, 2003. In my analyses below, I consider the
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`ordinarily skilled artisan’s understanding as of January 21, 2003, but confirm that
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`my opinions remain the same even if applying the January 16, 2003 date.
`
`35.
`
`I have been instructed by counsel that the “time of the invention” for
`
`the purposes of the ‘606 patent is January 21, 2003. I also have been instructed
`
`that the “critical date” is January 16, 2003. In my analyses below, I consider the
`
`ordinarily skilled artisan’s understanding as of January 21, 2003, but confirm that
`
`my opinions remain the same even if applying the January 16, 2003 date.
`
`36.
`
`I understand that a person of ordinary skill in the art provides a
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`reference point from which the prior art and claimed invention should be viewed.
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`This reference point prevents one from using his or her own insight or hindsight in
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`deciding whether a claim is obvious. Thus, “hindsight reconstruction” cannot be
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`used to combine references together to reach a conclusion of obviousness.
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`37.
`
`I also understand that an obviousness determination includes the
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`consideration of various factors such as (1) the scope and content of the prior art,
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`(2) the differences between the prior art and the claims, (3) the level of ordinary
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`skill in the pertinent art, and (4) the existence of secondary considerations of non-
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`obviousness.
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`38.
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`I have been informed and understand that the obviousness analysis
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`requires a comparison of the properly construed claim language to the prior art to
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`determine whether the claimed subject matter as a whole would have been obvious.
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`A claimed invention can be obvious when, for example, there is some teaching,
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`suggestion, or motivation in the prior art that would have led one of ordinary skill
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`to modify the prior art reference or to combine prior art reference teachings to
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`arrive at the claimed invention. In other words, even if one reference does not show
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`the whole of the invention, if it would have been obvious to a person of ordinary
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`skill in the art at the relevant time to add the missing pieces to the invention (for
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`example as a matter of standard engineering practice or application of a well-
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`known principle in the field), then a single reference can render a claim invalid
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`even if it does not show the whole invention. Moreover, a combination of two or
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`more references can render a claim invalid as obvious whether or not there is an
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`explicit suggestion in one of the references to combine the two references, if as a
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`matter of engineering skill or practice in the field it would be known to do so.
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`39. And as stated above, secondary considerations must be examined to
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`determine whether a certain invention would have been obvious to one of ordinary
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`skill in the art. I understand that secondary considerations of non-obviousness are
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`part of the obviousness inquiry under § 103, and that some examples of secondary
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`considerations include:
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`(1)
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`any long-felt and unmet need in the art that was satisfied by the
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`invention of the patent;
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`(2)
`(3)
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`any failure of others to achieve the results of the invention;
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`any commercial success or lack thereof of the products and
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