UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`CIPLA LIMITED,
`Petitioner
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`v .
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`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`U.S. Patent No. 8,791,154 to Gamache et al.
`Case No.: IPR2018-01020
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Case No.: IPR2018-01021
`____________________
`
`
`DECLARATION OF DR. PAUL A. LASKAR PH.D.
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`Declaration of Paul A. Laskar, Ph.D.
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`
`Table of Contents
`INTRODUCTION ........................................................................................... 1
`I.
`II. MY EXPERIENCE AND QUALIFICATIONS ............................................. 2
`III. LIST OF MATERIALS CONSIDERED ........................................................ 6
`IV. LEGAL STANDARD ..................................................................................... 7
`A. Obviousness ........................................................................................... 7
`V. NONE OF THE CLAIMS ARE ENTITLED TO THE PRIORITY
`DATE OF PROVISIONAL APPLICATION 61/487,789 ............................ 10
`VI. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) ....................... 12
`VII. THE GAMACHE PATENTS ........................................................................ 14
`VIII. CLAIM CONSTRUCTION .......................................................................... 16
`IX. SCOPE AND CONTENT OF THE PRIOR ART ......................................... 18
`A. Olopatadine ......................................................................................... 19
`B.
`Cyclodextrins ....................................................................................... 21
`C.
`Ophthalmic Formulations of Olopatadine For Treatment of
`Allergic Conjunctivitis ........................................................................ 25
`1.
`Bhowmick ................................................................................. 25
`2.
`Yanni ......................................................................................... 26
`3.
`Castillo ...................................................................................... 27
`4.
`Schneider ................................................................................... 27
`5.
`Hayakawa .................................................................................. 28
`6.
`Abelson ..................................................................................... 29
`INVALIDITY OF THE ’154 PATENT ........................................................ 30
`A.
`Claims 1-27 of the ’154 Patent are Rendered Obvious by
`Bhowmick in View of Yanni and Castillo .......................................... 30
`1.
`Claim 1 ...................................................................................... 31
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`X.
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`Declaration of Paul A. Laskar, Ph.D.
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`a)
`
`b)
`
`c)
`d)
`e)
`f)
`g)
`h)
`
`“An aqueous ophthalmic solution for treatment of
`ocular
`allergic
`conjunctivitis,
`the
`solution
`comprising” ..................................................................... 31
`“at least 0.67 w/v % olopatadine dissolved in the
`solution” .......................................................................... 32
`“PEG having a molecular weight of 300 to 500” ........... 34
`“polyvinylpyrrolidone” ................................................... 36
`“hydroxypropyl-γ-cyclodextrin” .................................... 38
`“benzalkonium chloride” ................................................ 39
`“Water” ........................................................................... 39
`Even if Yanni May Teach Suspensions in Certain
`Instances that Would Not Render the Gamache
`Patents any Less Obvious ............................................... 40
`The Skilled Artisan Would Not Be Dissuaded
`From Using Multiple Solubilizing Agents ..................... 44
`Reasonable Expectation of Success ................................ 47
`j)
`Claims 4 and 8 ........................................................................... 48
`2.
`Claim 21 .................................................................................... 54
`3.
`Claims 2, 5, and 9...................................................................... 56
`4.
`Claims 3, 6, 10, and 18 ............................................................. 57
`5.
`Claims 7 and 11 ......................................................................... 58
`6.
`Claims 19 and 20....................................................................... 58
`7.
`Claim 24 .................................................................................... 59
`8.
`Claims 12-14 and 25-27 ............................................................ 60
`9.
`10. Claims 15-17 and 22 ................................................................. 61
`11. Claim 23 .................................................................................... 62
`Ground 2: Claims 1-27 are Rendered Obvious by Schneider in
`view of Hayakawa, Bhowmick, and Castillo ...................................... 63
`1.
`Claim 1 ...................................................................................... 63
`a)
`“An aqueous ophthalmic solution for treatment of
`ocular
`allergic
`conjunctivitis,
`the
`solution
`comprising” ..................................................................... 63
`“at least 0.67 w/v % olopatadine dissolved in the
`solution” .......................................................................... 64
`“PEG having a molecular weight of 300 to 500” ........... 65
`“polyvinylpyrrolidone” ................................................... 66
`“hydroxypropyl-γ-cyclodextrin” .................................... 67
`
`i)
`
`b)
`
`c)
`d)
`e)
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`B.
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`XI.
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`2.
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`Declaration of Paul A. Laskar, Ph.D.
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`“benzalkonium chloride” ................................................ 68
`f)
`“Water” ........................................................................... 68
`g)
`Reasonable Expectation of Success ................................ 68
`h)
`Claim 4 and 8 ............................................................................ 69
`2.
`Claim 21 .................................................................................... 73
`3.
`Claims 2, 5, and 9...................................................................... 76
`4.
`Claims 3, 6, 10, and 18 ............................................................. 77
`5.
`Claims 7 and 11 ......................................................................... 77
`6.
`Claims 19 and 20....................................................................... 78
`7.
`Claim 24 .................................................................................... 79
`8.
`Claims 12-14 and 25-27 ............................................................ 80
`9.
`10. Claims 15-17 and 22 ................................................................. 80
`11. Claim 23 .................................................................................... 81
`INVALIDITY OF THE ’053 PATENT ........................................................ 83
`A. Ground 1: Claims 1-13 are Rendered Obvious by Bhowmick in
`view of Yanni, Castillo, and Abelson ................................................. 83
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ........................................... 83
`Differences Between the Claims and the Prior Art .................. 83
`a)
`Claim 1 ............................................................................ 83
`“An aqueous ophthalmic
`solution
`for
`treatment of ocular allergic conjunctivitis,
`the solution comprising” ...................................... 83
`“at least 0.67 w/v % olopatadine dissolved
`in the solution” ..................................................... 84
`“PEG having a molecular weight of 200 to
`800” ...................................................................... 86
`“polyvinylpyrrolidone” ........................................ 88
`“a cyclodextrin selected from the group
`consisting
`of
`SAE-β-cyclodextrin,
`hydroxypropyl-β-cyclodextrin
`and
`hydroxypropyl-γ-cyclodextrin; and” .................... 90
`“Water” ................................................................. 90
`
` Reasonable Expectation of Success ..................... 91
`Claim 8 ............................................................................ 91
`iii
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`b)
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`Declaration of Paul A. Laskar, Ph.D.
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`Claim 2 ............................................................................ 92
`c)
`Claims 3 and 9 ................................................................ 93
`d)
`Claims 4 and 10 .............................................................. 93
`e)
`Claims 5 and 11 .............................................................. 94
`f)
`Claims 6 and 12 .............................................................. 94
`g)
`Claims 7 and 13 .............................................................. 95
`h)
`Ground 2: Claims 1-13 are Rendered Obvious by Schneider in
`view of Hayakawa, Bhowmick, Castillo, and Abelson ....................... 97
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ........................................... 97
`Differences Between the Claims and the Prior Art .................. 98
`a)
`The Prior Art ................................................................... 98
`b)
`Claim 1 ............................................................................ 98
`“An aqueous ophthalmic
`solution
`for
`treatment of ocular allergic conjunctivitis,
`the solution comprising” ...................................... 98
`“at least 0.67 w/v % olopatadine dissolved
`in the solution” ..................................................... 98
`“PEG having a molecular weight of 200 to
`800” ...................................................................... 99
`“polyvinylpyrrolidone” ......................................101
`“a cyclodextrin selected from the group
`consisting
`of
`SAE-β-cyclodextrin,
`hydroxypropyl-β-cyclodextrin
`and
`hydroxypropyl-γ-cyclodextrin; and” ..................102
`“Water” ...............................................................102
`
` Reasonable Expectation of Success ...................103
`Claim 8 ..........................................................................103
`Claim 2 ..........................................................................104
`Claims 3 and 9 ..............................................................105
`Claims 4 and 10 ............................................................105
`Claims 5 and 11 ............................................................106
`Claims 6 and 12 ............................................................106
`Claims 7 and 13 ............................................................107
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`B.
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`2.
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`c)
`d)
`e)
`f)
`g)
`h)
`i)
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`Declaration of Paul A. Laskar, Ph.D.
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`C.
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`2.
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`
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`Ground 3: Claims 1-13 are Rendered Obvious by Bhowmick,
`Schneider, Castillo, and Abelson ......................................................108
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art .........................................108
`Differences Between the Claims and the Prior Art ................108
`a)
`Claim 1 ..........................................................................108
`“An aqueous ophthalmic
`solution
`for
`treatment of ocular allergic conjunctivitis,
`the solution comprising” ....................................108
`“at least 0.67 w/v % olopatadine dissolved
`in the solution” ...................................................109
`“PEG having a molecular weight of 200 to
`800” ....................................................................110
`“polyvinylpyrrolidone” ......................................111
`“a cyclodextrin selected from the group
`consisting
`of
`SAE-β-cyclodextrin,
`hydroxypropyl-β-cyclodextrin
`and
`hydroxypropyl-γ-cyclodextrin; and” ..................111
`“Water” ...............................................................112
`
` Reasonable Expectation of Success ...................112
`Claim 8 ..........................................................................112
`b)
`Claim 2 ..........................................................................113
`c)
`Claims 3 and 9 ..............................................................113
`d)
`Claims 4 and 10 ............................................................114
`e)
`Claims 5 and 11 ............................................................114
`f)
`Claims 6 and 12 ............................................................114
`g)
`Claims 7 and 13 ............................................................115
`h)
`XII. SECONDARY CONSIDERATIONS .........................................................115
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`I, Paul A. Laskar, Ph.D., do hereby declare and state as follows:
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`1.
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`I have been asked to provide testimony as to what one of ordinary
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`skill in the art would have understood with respect to the patents at issue and
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`various prior art discussed herein. I provide this testimony below:
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`I.
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`INTRODUCTION
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`2.
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`I am over the age of eighteen (18) and otherwise competent to make
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`this Declaration.
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`3.
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`I have been retained on behalf of Petitioner for the above-captioned
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`inter partes reviews (“IPRs”). I am being compensated for my time in connection
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`with this IPR at my standard consulting rate, which is $300 per hour for consulting;
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`$375 per hour for deposition and testimony, including preparation; $125 per hour
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`for non-working travel time. My compensation does not depend in any way on the
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`outcome of any of the IPRs.
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`4.
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`It is my understanding that the Petitions for Inter Partes Review in
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`this matter involve U.S. Patent No. 8,791,154 (“the ’154 patent”) (EX1001) and
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`U.S. Patent No. 9,533,053 (“the ’053 patent”) (EX1002) (collectively, “the
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`Gamache Patents”).
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`5.
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`Both Gamache Patents name Daniel A. Gamache, Laman Alani,
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`Malay Ghosh, Francisco Javier Galán, Núria Carreras Perdiguer, and Onkar N.
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`Singh as the purported inventors. I understand that the ’053 patent is a
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`continuation of the ’154 patent, and therefore has the same specification in all
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`material respects (differing only as to its claims).
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`6.
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`It is also my understanding that Patent Owner contends the priority
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`date of the Gamache Patents is May 19, 2011—the filing date of Provisional
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`Application No. 61/487,789. However, I understand that Petitioner contends the
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`priority date is October 19, 2011—the filing date of Provisional Application
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`No. 61/548,957. I further understand that the Gamache Patents are assigned to
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`Alcon Research, Ltd. (“Alcon,” “Patentee,” or “Patent Owner”).
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`7.
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`As explained below, it is my opinion is that all claims of the Gamache
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`Patents would have been obvious to the skilled artisan, and therefore are invalid.
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`II. MY EXPERIENCE AND QUALIFICATIONS
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`8.
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`I am an expert in the field of formulations and drug delivery,
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`specifically pharmaceutical formulations for ophthalmic administration, including
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`topical aqueous liquid preparations, and I have been an expert in this field since
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`well before 2011, which I understand is the priority date of the patents (the priority
`
`date issue will be discussed specifically later in this declaration). Throughout the
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`remainder of this Declaration, I will refer to the field of ophthalmic formulations,
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`and specifically pharmaceutical formulations for ophthalmic preparations, as the
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`relevant field or the relevant art. In formulating my opinions, I have relied upon
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`my training, knowledge, and experience in the relevant art. A copy of my current
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`curriculum vitae is attached to this declaration as EX1037, and it provides a
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`comprehensive description of my academic and employment history.
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`9.
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`As an expert in the relevant field since prior to 2011, I am qualified to
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`provide an opinion as to what a Person of Ordinary Skill (“POSA” or “the skilled
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`artisan”) would have understood, known, or concluded as of 2011. Indeed, since
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`1965, I have accumulated significant training and experience in the field of
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`pharmaceutical formulations for ophthalmic administration.
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`10.
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`I have a Ph.D. in Pharmaceutical Sciences from Oregon State
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`University with a Minor in Biostatistics; a M.B.A. in General Management,
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`International Management and Marketing from the University of California at
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`Irvine; a M.S. in Pharmacy and a B.S. in Pharmacy from the University of Illinois;
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`and a B.A. in General Science (Chemistry, Biology) from the University of
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`Rochester.
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`11.
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`I am currently, and have been since October 2006, the President of
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`Paul Laskar Associates, Inc., a pharmaceutical development consulting firm that I
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`founded. My client base consists of start-up and established pharmaceutical
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`companies with whom I consult in the areas of pharmaceutical development,
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`including formulation, development, and evaluation. A significant fraction of my
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`work on my clients’ behalf focuses on ophthalmic products and preparations.
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`From 2003 to 2006, I was Senior Director, Pharmaceutical Development at Dey
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`LP, at that time owned by Merck KGaA. In that capacity, I supervised the
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`formulation development, clinical supply, technology transfer, pilot operations,
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`and preclinical functions. While most of Dey’s projects were for inhalation, I
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`worked on two generic ophthalmic projects.
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`12. From 1994 to 2003, I was initially Director, then Vice President,
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`Pharmaceutical Development, and subsequently Principal Director, Pharmaceutics
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`and Technology, at Santen Inc., the U.S. subsidiary of the Japanese ophthalmic
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`pharmaceutical company, Santen Ltd. My responsibilities included directing
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`ophthalmic formulation development, stability assessment, technology transfer,
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`preparation of internal reports and regulatory documents, and review of in-license
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`candidates. The areas I supervised included: formulation development, analytical
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`chemistry and stability assessment, clinical supplies, and non-clinical development.
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`During my tenure with Santen Inc., three ophthalmic projects, Quixin, Betimol,
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`and Alamast, resulted in successful New Drug Applications (“NDAs”) by the Food
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`and Drug Administration (“FDA”) and commercial launch. A fourth NDA, Iquix,
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`and a prostaglandin compound, taflutan (now marketed in the U.S. as Zioptan®),
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`to which I contributed to its formulation as well as chemistry, manufacturing and
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`control (“CMC”) development strategy, were approved subsequent to my leaving
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`Santen.
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`13. From 1993 to 1994, I was Director, Pharmaceutical Development, at
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`CoCensys, Inc., a start-up pharmaceutical company. During this time, I directed
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`CMC development of two new chemical entities (“NCE”), one for oral use as a
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`suspension and solid drug product, and the second as a parenteral. The oral NCE
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`was successfully formulated as a suspension and submitted as an investigational
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`new drug (“IND”) application to the FDA.
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`14. From 1982 to 1993, I was employed by Allergan, Inc., an ophthalmic
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`specialty company. Initially, I was a Scientist, Product Development, then I
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`became a Section Manager and eventually Manager in the same area, and, finally,
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`Director, Product Development. While at Allergan, I was involved in the
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`formulation and subsequent development of a number of ophthalmic and
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`dermatological drug products, many of which were approved as NDAs by the FDA
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`and their equivalents in other countries/jurisdictions. From 1973 to 1982, I was
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`Assistant Professor of Pharmacy at the College of Pharmacy, University of Illinois
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`Medical Center (now University of Illinois-Chicago Campuses) and then Associate
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`Professor of Pharmacy at the School of Pharmacy at Creighton University. During
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`this time, among the courses I taught were those in dosage form development
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`including oral solids, ophthalmics, and dermatologicals.
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`15. At present, I provide consulting services to start-up and established
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`pharmaceutical companies for pharmaceutical projects. The nature of the projects
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`include ophthalmics, sterile parenterals, dermatologicals, and liquid and solid oral
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`drug products. The areas in which I consult include active pharmaceutical
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`ingredient (API) manufacture and qualification, formulation development, stability
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`assessment, analytical development, manufacturing process development and
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`transfer, contract laboratory and drug product manufacturer identification and their
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`management, and preparation of regulatory documents.1
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`III. LIST OF MATERIALS CONSIDERED
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`16.
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`In formulating my opinions, I have considered the materials
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`referenced in this Declaration, the Exhibit List and those referenced in the Petitions
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`for Inter Partes Review of the Gamache Patents. I also have reviewed the
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`Gamache Patents (EX1001 & EX1002) and their respective prosecution histories
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`as well as each of the documents cited herein in light of the general knowledge in
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`the state of the art as of October 19, 2011.2
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`1 I reserve the right to further explain my background and qualifications in
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`deposition where needed.
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`2 I note that my opinions would not change if the priority date is determined
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`to be May 19, 2011.
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`IV. LEGAL STANDARD
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`17. Although I am not a lawyer, I have been informed by counsel and
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`provide my general understanding of the law of obviousness. I used these
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`principles in conducting my analysis and drawing any conclusions.
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`18.
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`I understand that the first step in determining whether a patent claim
`
`would have been obvious is to construe the claims to determine claim scope and
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`meaning. I understand that in IPR proceedings, the claim terms are generally given
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`the broadest reasonable interpretation, i.e., their ordinary and customary meaning
`
`as would have been understood by a POSA at the time, in the context of the entire
`
`patent disclosure.
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`A. Obviousness
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`19.
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`I understand that a patent claim is invalid if the differences between
`
`the claimed invention and prior art are such that the subject matter as a whole
`
`would have been obvious at the time the invention was made to a POSA.
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`20.
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`I have been told the following factors (sometimes referred to as the
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`Graham factors) are used in making an obviousness determination: a) the scope
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`and content of the prior art; b) the differences between the prior art and the claimed
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`invention; c) the level of ordinary skill in the pertinent art; and d) any secondary
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`considerations evidencing nonobviousness.
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`21.
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`I also understand that obviousness can be established by combining or
`
`modifying the teachings of the prior art. A claimed invention can be obvious
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`when, for example, there is some teaching, suggestion, or motivation in the prior
`
`art that would have led a POSA to modify the prior art reference or to combine
`
`prior art reference teachings to arrive at the claimed invention.
`
`22.
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`I also understand that the prior art references themselves do not have
`
`to provide an explicit teaching, suggestion, or motivation to combine prior art
`
`teachings; rather, the analysis may rely on interrelated teachings, market demands,
`
`the background knowledge possessed by a POSA, and/or common sense. Put
`
`another way, the motivation to combine or modify prior art references can come
`
`from any reason to do so, and is not limited to the reasons that may have motivated
`
`the patentee.
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`23.
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`I am also informed that a combination of familiar elements according
`
`to known methods is likely to be obvious when it does no more than yield
`
`predictable results. I also understand that when a person of ordinary skill would
`
`have reached the claimed invention through routine experimentation, the invention
`
`may be deemed obvious.
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`24.
`
`I understand that various rationales are utilized to determine whether a
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`claim
`
`is obvious,
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`including, among others:
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` (i) simple substitution or
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`interchangeability of one known element for another to obtain predictable results;
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`(ii) use of known techniques to improve similar methods or products in the same
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`way; (iii) applying a known technique to a known method or product ready for
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`improvement to yield predictable results; (iv) “obvious to try”—choosing from a
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`finite number of identified, predictable solutions, with a reasonable expectation of
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`success; and (v) known work in one field of endeavor prompting variations of it for
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`use in either the same field or a different one based on design incentives or other
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`market forces if the variations would have been predictable to one of ordinary skill
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`in the art.
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`25. As stated above, I understand that secondary considerations of
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`non-obviousness are part of the obviousness inquiry. I understand that these
`
`secondary considerations may include failure of others, copying, unexpectedly
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`superior results, perception in the industry, commercial success, and long-felt but
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`unmet need. I also understand that in order for secondary considerations of non-
`
`obviousness to be applicable, they must have a nexus to the claimed subject matter.
`
`I understand that this nexus (i.e., link) includes a connection between the subject
`
`matter of the claim and the alleged secondary considerations.
`
`26.
`
`I understand that I cannot use hindsight in any obviousness analysis.
`
`In connection with my opinions, I did not use hindsight, nor did I use the claims
`
`and/or the disclosure of the Gamache Patents as a blueprint for piecing together the
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`prior art to arrive at the claimed invention. As part of the obviousness analysis,
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`and to avoid hindsight, I placed in mind back to the time of invention (i.e., the
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`relevant priority date (discussed further below)) and considered the thinking of
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`POSA, guided only by the prior art references and the then-accepted wisdom in the
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`field.
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`V. NONE OF THE CLAIMS ARE ENTITLED TO THE PRIORITY
`DATE OF PROVISIONAL APPLICATION 61/487,789
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`27. Every independent claim of the Gamache Patents recites either
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`“hydroxypropyl-γ-cyclodextrin” or “HP-γ-cyclodextrin.” EX1001, EX1002. I
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`have reviewed the ’789 Provisional (i.e., the specification and claims) and it fails
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`to even mention any γ-cyclodextrins or derivatives of γ-cyclodextrins; instead, the
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`’789 Provisional exclusively focuses on “includ[ing] a β-cyclodextrin derivative to
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`aid in the solubility of the olopatadine” (EX1009, Bates page 9, lines 2-7), with all
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`examples relying on a β-cyclodextrin derivative (id., Tables A-H).
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`28.
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`γ-cyclodextrins and β-cyclodextrin (and their associated derivatives)
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`are different cyclodextrins with different attributes and properties as clearly
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`evidenced by the HPE. EX1012; infra, ¶¶ 53-57.
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`29. Because of the fact that γ-cyclodextrins and β-cyclodextrin (and their
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`associated derivatives) are different cyclodextrins, the ’789 Provisional fails to
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`reasonably convey to the skilled artisan (as I have defined it below) the inclusion
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`of hydroxypropyl-γ-cyclodextrin in any of its compositions. See infra, ¶¶ 30-35.
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`Therefore, in my view, the skilled artisan would conclude that the Patent Owner
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`did not have possession of compositions containing hydroxypropyl-γ-cyclodextrin
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`at the time of filing of the ’789 Provisional.3 Since the skilled artisan would have
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`concluded that the ’789 Provisional does not show the Patent Owner had
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`3 It is my understanding that a patent specification must describe the claimed
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`invention in sufficient detail that one skilled in the art can reasonably conclude that
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`the inventor had possession of the claimed invention. I have been informed that a
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`satisfactory description may be found in originally filed claims or any other portion
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`of the originally filed specification. However, that does not mean that all
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`originally filed claims have adequate written support. The specification must still
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`be examined to assess whether an originally filed claim has adequate written
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`support. Furthermore, it is my understanding that an applicant shows possession of
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`the claimed invention by describing the claimed invention with all of its limitations
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`using such descriptive means as words, structures, figures, diagrams, and formulas
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`that fully set forth the claimed invention. Possession may be shown in a variety of
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`ways, including description of an actual reduction to practice, by showing that the
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`invention was ready for patenting such as by the disclosure of drawings or
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`structural chemical formulas that show that the invention was complete, or by
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`describing distinguishing identifying characteristics sufficient to show that the
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`applicant was in possession of the claimed invention.
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`possession of compositions containing hydroxypropyl-γ-cyclodextrin (or for that
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`matter any γ-cyclodextrin derivative), I have been informed to use the October 19,
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`2011 priority date of Provisional Application No. 61/548,957 (EX1010) for the
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`Gamache Patents.
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`VI. PERSON OF ORDINARY SKILL IN THE ART (“POSA”)
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`30.
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`In arriving at my opinions, I have relied on my experience in the
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`relevant art and have considered the point of view of a person of ordinary skill in
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`the art as of the relevant priority date.4
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`31. As of the relevant priority date, a POSA in the relevant field would
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`have had: (i) an M.D., Pharm.D. or Ph.D.
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`in chemistry, biochemistry,
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`pharmaceutics, or in a related field, and at least about two years of relevant
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`experience in the treatment of ocular diseases and developing formulations used to
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`treat ocular diseases, including topical eye pharmaceuticals; (ii) a master’s degree
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`in chemistry, biochemistry, pharmaceutics, or in a related field, and at least about
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`five years of the same relevant experience; or (iii) a bachelor’s degree in pharmacy,
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`4 Even if the correct priority date were determined to be May 19, 2011,
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`rather than October 19, 2011, as explained below, given the closeness of these two
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`dates, the understanding and related testimony of a POSA as described herein
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`would not change.
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`chemistry, biochemistry, or in a related field, and have at least about 10 years of
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`the same relevant experience.
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`32. Further, a POSA would typically work as part of a multidisciplinary
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`team and draw upon not only his or her own skills, but also take advantage of
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`certain specialized skills of others in the team to solve a given problem should the
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`need arise.
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`33.
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`In determining the qualificati