throbber
Applicant :
`Serial No. :
`Filed
`Page
`
`James S. Baldassarre et al.
`12/820,866
`June 22, 20 I 0
`22 of23
`
`Attorney's Docket No.: 100 1-0002USC I
`
`Rejection for Nonstatutory Obviousness-type Double Patenting
`
`Claims 20-27 stand provisionally rejected for alleged obviousness-type double patenting over
`claims 21-28 of copending Application No. 12/820980, claims 21-30 of copending Application
`No. 12/821020, and claims 21-29 and 37 of copending Application No. 12/821041. Claims 20-27 of
`the present application have been canceled and replaced with new claims 28-42. As the claims of all
`of the cited applications remain under prosecution and the obviousness-type double patenting
`rejections are provisional, it is premature to detennine whether a terminal disclaimer is appropriate.
`Applicants will consider that question at the point that the claims are deemed otherwise allowable.
`
`CONCLUSION
`
`Applicants have conclusively established, based on scientific reasoning and objective
`evidence that includes written statements by Dr. Wessel, that Atz & Wessel failed to teach one
`skilled in the art to avoid the use of inhaled nitric oxide in the patients recited in the present claims
`(neonates with left ventricular dysfunction who are not dependent on a right-to-left shunt). Indeed,
`even Dr. Wessel, the senior author of Atz and Wessel, expressly states that at the time of the original
`design of the INOT22 protocol, neither he, the study Sponsor, nor the other Steering Committee
`members appreciated or anticipated that a pediatric patient with left ventricular dysfunction who is
`not dependent on right-to-left shunting of blood would be at additional risk when treated with inhaled
`NO. Further evidence provided herein demonstrates that the opinion of Dr. Wessel is not an isolated
`one, as at least 115 additional medical experts who reviewed the original INOT22 protocol failed to
`suggest that the exclusion criteria be amended to exclude study subjects with pre-existing left
`ventricular dysfunction who are not dependent on right-to-left shunting of blood.
`Moreover, applicants have explained, based on scientific reasoning and objective evidence,
`that one of ordinary skill in the art would not have read Kinsella et al. as teaching that infants with
`congenital heart disease are at risk for adverse events if treated with inhaled nitric oxide; indeed, the
`Fraisse & Wessel article proves that it is well known in the art that inhaled nitric oxide is a
`"standard" treatment for pediatric cardiac patients. Finally, applicants have elucidated in detail why
`one of ordinary skill in the art would not have derived from Loh et al.'s statements about adults with
`
`Ex. 2007-0801
`
`

`
`Applicant : James S. Baldassarre et al.
`Serial No. : 12/820,866
`Filed
`June 22, 20 1 0
`Page
`: 23 of23
`
`Attorney's Docket No.: 100 l-0002USC t
`
`class III or class IV congestive heart failure and LVD anything of relevance to term or near-term
`
`neonates. The science-based explanations provided by applicants are fully supported by the
`
`objective evidence of nonobviousness of record in this application. Applicants submit that the claims
`
`are in condition for allowance, and such action is respectfully requested.
`
`Please apply any additional necessary charges or credits to deposit account 12-0769,
`referencing Attorney Docket No. 1001-0002USC1.
`
`Respectfully submitted,
`
`/Jonathan N. Provoost, Reg. No. 44,292/
`Jonathan N. Provoost
`Attorney for Applicant and Assignee
`Associate General Counsel
`lkaria
`6 Route 173
`Clinton, NJ 08809
`Direct phone: (908) 238-6392
`Cell: (908) 391-3440
`Fax (legal dept.): (908) 238-6773
`jonathan. provoost@ikaria.com
`
`Dated: July 8. 2011
`
`Ex. 2007-0802
`
`

`
`Applicant :
`Serial No. :
`Filed
`Page
`
`James S. Baldassarre et al.
`12/820,866
`June 22, 20 I 0
`24 of23
`
`Attorney's Docket No.: 1001-0002USCI
`
`APPENDIX A
`
`(curriculum vitae of Dr. David L. Wessel)
`
`Ex. 2007-0803
`
`

`
`CURRICULUM VITAE
`
`Wessel
`
`Page 1 of 39
`
`1) PERSONAL DATA
`
`Date prepared:
`
`April2011
`
`Name:
`
`David Lloyd Wessel
`
`Home address:
`
`3251 Prospect St. NW, Suite 404 Washington, D.C. 20007
`
`Home phone:
`
`202-342-0908
`
`Office Address:
`
`Children's National Medical Center
`111 Michigan Ave, NW Suite 3W-1 00 Washington, DC 20007
`TEL: 202 476 5047 FAX: 202 476-5868
`
`E-Mail Address:
`
`dwessel@childrensnational.org
`
`Place of Birth:
`
`Newton, Iowa U.S.A.
`
`Citizenship:
`
`United States
`
`2) EDUCATION:
`
`B.S.
`1972
`1974
`B.A.
`1978 M.D.
`1983 M.A.
`
`College of William and Mary (Physics), Williamsburg, VA
`Oxford University (Physiology), Oxford, England
`Yale University School of Medicine (Medicine), New Haven, CT
`Oxford University (Physiology), Oxford, England
`
`POSTDOCTORAL TRAINING:
`Internship and Residencies:
`1978-79
`Intern in Pediatrics, Yale-New Haven Hospital, New Haven, CT
`1979-80
`Resident in Pediatrics, Yale-New Haven Hospital, New Haven, CT
`Resident in Anesthesia, Massachusetts General Hospital, Boston, MA
`1981-83
`Fellowships:
`1980-81
`1983-84
`1984-85
`
`Fellow in Pediatric Cardiology and Intensive Care, Yale-New Haven Hospital, New Haven, CT
`Fellow in Pediatric Cardiology, Children's Hospital, Boston, MA
`Fellow in Anesthesia and Intensive Care, Children's Hospital, Boston, MA
`
`3) EMPLOYMENT
`
`CHILDREN'S HOSPITAL, BOSTON
`1985-87
`Assistant in Anesthesia
`1985-88
`Assistant in Cardiology
`1987-00
`Associate in Anesthesia
`1988-89
`Associate in Cardiology
`1988-07
`Associate in Cardiovascular Surgery
`1988-02
`Chief, Cardiovascular Intensive Care Unit
`1989-07
`Senior Associate in Cardiology
`1995-02
`Division Chief
`2000-07
`Senior Associate in Anesthesia
`2002-03
`Honorary Consultant, Royal Brompton Hospital, London, U.K.
`
`Ex. 2007-0804
`
`

`
`Wessel
`
`Page 2 of 39
`
`CHILDREN'S NATIONAL MEDICAL CENTER, WASHINGTON, DC
`2007-
`Interim Chief, Division of Critical Care Medicine
`Executive Director, Center for Hospital Based Specialties
`2007-09
`Senior Vice President, Center for Hospital Based Specialties
`2009-
`2010-
`I KARIA Distinguished Professor of Critical Care Medicine, Children's National Medical Center,
`Washington, DC
`
`ACADEMIC APPOINTMENTS:
`1980-81
`Fellow in Pediatrics (Cardiology), Yale School of Medicine, New Haven, CT
`1981-83
`Clinical Fellow in Anaesthesia, Harvard Medical School, Boston, MA
`1983-84
`Clinical Fellow in Pediatrics, Harvard Medical School, Boston, MA
`1984-85
`Clinical Fellow in Anaesthesia, Harvard Medical School, Boston, MA
`1985-86
`Instructor in Anaesthesia, Harvard Medical School, Boston, MA
`1987-93
`Assistant Professor of Anaesthesia (Pediatrics), Harvard Medical School, Boston,
`1987-94
`Assistant Professor of Pediatrics (Anaesthesia), Harvard Medical School, Boston, MA
`1994-99
`Associate Professor of Pediatrics, Harvard Medical School, Boston, MA
`1999-02
`Associate Professor of Pediatrics (Anaesthesia), Harvard Medical School, Boston, MA
`2002-03
`Visiting Professor Imperial College, University of London, London UK (4/02-4/03)
`2002-07
`Professor of Pediatrics (Anaesthesia), Harvard Medical School, Boston, MA
`2011-
`Professor of Pediatrics, George Washington University School of Medicine and Health Sciences,
`Washington, DC (pending)
`
`4) LICENSURE AND CERTIFICATION:
`1979
`National Board of Medical Examiners
`1985-07
`Massachusetts License Registration
`1985
`American Board of Pediatrics (Permanent)
`1985
`American Board of Pediatrics, Sub-board of Pediatric Cardiology (Permanent)
`1986
`American Board of Anesthesiology (Permanent)
`1987
`American Board of Pediatrics, Sub-board of Critical Care (Re-certified 1996, 2004, 201 0)
`5) PROFESSIONAL SOCIETIES & HONORS:
`1982-
`American Society of Anesthesiologists
`1982-2007 Massachusetts Medical Society
`1986-
`American Academy of Pediatrics
`1987-
`Society of Critical Care Medicine
`1987-
`American Society of Critical Care Anesthesiologists
`1987-
`Society of Pediatric Anesthesia
`1989-
`American Heart Association (Fellow)
`1991-
`Society of Cardiovascular Anesthesiologists
`1995-
`Society of Pediatric Research
`1999-
`Pediatric Cardiac Intensive Care Society - President 2000-2004; Vice President,
`Development 201 0-
`
`AWARDS, HONORS AND NAMED LECTURES:
`1968 Maytag Scholar (industry sponsored competitive college scholarship)
`1971
`Phi Beta Kappa
`1971 Omicron Delta Kappa
`1971
`National Physics Honor Society (President)
`1972 General Honors (William and Mary)
`1972 Drapers' Scholar (Oxford)
`1972 Mathematics Honor Society
`1974
`Balliol College Prize (Oxford)
`197 4
`First Class Honours (Oxford)
`1978 Cum Laude (Yale)
`1978
`Alpha Omega Alpha Honor Medical Society
`1978 Harry S. Greene Prize (Yale)
`
`Ex. 2007-0805
`
`

`
`Wessel
`
`Page 3 of 39
`
`1994
`1994
`1994
`1995
`1995
`
`1996
`1997-
`1999
`
`2000
`
`Katkov-Lundeen Memorial Lecture, Minneapolis Children's Hospital, Minneapolis, MN
`Saul Usher Memorial Lecture, Montreal Children's Hospital, Montreal, Canada
`Farouk ldriss Memorial Lecture, Children's Memorial Hospital, Chicago, IL
`A. W. Conn Lecture, Hospital for Sick Children, Toronto, Canada
`DiCerbo Foundation Lectureship in Pediatric Critical Care, North Shore University Hospital,
`New York, NY
`Teaching Award, Pediatric Cardiology, Children's Hospital Boston
`Listed, Best Doctors in America, continuously since inception
`29th Annual Jennifer B. Lalin Lecture, Babies Hospital, Columbia University College of
`Physicians and Surgeons, New York, NY
`Tenth Anniversary Lecture, Taiwan Pediatric Association, Critical Care Sub Committee,
`Kaohsiung Veterans General Hospital, Taipei, Taiwan
`Recipient, Papas Gift Award for Outstanding Clinical Care ($25,000 to Children's Hospital Boston)
`2001
`2002 M.A. (Honorary) Harvard University, Cambridge, MA
`Keynote Address, Opening Ceremony, Annual Meeting of the European Society of Pediatric and
`2004
`Neonatal Intensive Care, London, United Kingdom
`Leadership & Mentor Award: "In recognition of your contributions toward improving children's heart
`health," The Fifth International Symposium on Pediatric Cardiac Intensive Care co-sponsored by the
`Pediatric Cardiac Intensive Care Society and the Texas Children's Heart Center
`Jared Ellsworth Memorial Lecture, Rainbow Babies and Children's Hospital, Cleveland, Ohio
`2005
`Eddie Farrell Memorial Lecture, Massachusetts Society of Respiratory Care
`2006
`2007 Robert A. Boxer, M.D. Memorial Lecture, Schneider Children's Hospital LIJ, North Shore
`John J. Downes, Jr.,M.D. Lecture, Cardiology 2010, Orlando, FL. Sponsored by Children's Hospital
`2010
`Philadelphia.
`2010 Outstanding Research Award in Pediatric Cardiology (Council on Cardiovascular Disease in the Young),
`AHA Scientific Sessions, Chicago, IL
`Anthony Chang Honorary (Inaugural) Lecture. Pediatric Cardiac Intensive Care Society.
`
`2004
`
`2010
`
`6) ADMINISTRATIVE DUTIES & UNIVERSITY ACTIVITIES
`
`HOSPITAL AND HEALTH CARE ORGANIZATION SERVICE RESPONSIBILITIES:
`CHILDREN'S HOSPITAL. BOSTON
`Attending Physician and Associate Director, Multidisciplinary Intensive Care Unit
`1985-91
`Attending Physician in Cardiology (Intensive Care)
`1985-07
`Attending Physician in Anesthesia (Cardiac)
`1985-07
`Associate in Cardiovascular Surgery (teaching)
`1985-07
`
`CHILDREN'S NATIONAL MEDICAL CENTER. WASHINGTON. DC
`Attending Physician in Critical Care Medicine, Cardiology, Cardiac Anesthesia
`2007-
`Member, Children's National Heart Institute
`2007-
`
`MAJOR ADMINISTRATIVE RESPONSIBILITIES:
`CHILDREN'S HOSPITAL. BOSTON
`Director, Cardiac Intensive Care Unit
`1988-02
`Associate Director, Critical Care Pediatrics Training Program
`1990
`Treasurer, Board of Directors, Boston Children's Heart Foundation including investigative
`1993-02
`and forensic accounting responsibilities surrounding departed chairman (1993-96)
`Board of Directors, Children's Hospital Physicians' Organization, Boston, MA
`Physician Leadership Council, Children's Hospital, Boston, MA
`Medical Director, Pharmacy, Children's Hospital, Boston, MA
`Clinical Sponsor, Critical Care Clinical Information System, Children's Hospital, Boston, MA
`Interdisciplinary Peer Review Assignments and Presentation of Critical Events to JCAHO
`Board of Directors, Boston Children's Heart Foundation
`Physician Leadership Council, Children's Hospital, Boston, MA
`
`1997-98
`1998-03
`1999-02
`2000-02
`2003-04
`2004-05
`2004-05
`
`Ex. 2007-0806
`
`

`
`Wessel
`
`Page 4 of 39
`
`CHILDREN'S NATIONAL MEDICAL CENTER. WASHINGTON DC
`2007-
`Accountable executive for clinical Center of Excellence; $200M revenue, more than 700 full time
`employees. Includes divisions and departments of critical care medicine (both cardiac and pediatric ICU
`neonatology; hospitalist medicine (inpatient general pediatrics); emergency medicine; radiology; respirat
`care services (respiratory therapy); infectious disease, hospital infection control and epidemiology;
`endocrinology and the diabetes care complex; transport medicine, fetal and transitional medicine, ECM<
`Leadership Council
`Children's Hospital Foundation Board of Directors
`Critical Care Committee (Co-Chair)
`Executive Committee of the Medical Staff
`Executive Directors Council (Senior Vice President Council2008-)
`Hospital Based Specialties (HBS) Leadership Committee (Chair)
`HBS Campaign Council (Chair)
`Strategic Planning Council
`Interim Chief, Division of Critical Care Medicine
`Healthcare Review Committee (risk management financial governance)
`Steering Committee Strategic Planning Council (201 0-15)
`
`2007-
`2007-
`2007-
`2007-
`2007-
`2007-
`2007-
`2007-
`2007-
`2008-
`2009-
`
`MAJOR COMMITTEE ASSIGNMENTS:
`HARVARD MEDICAL SCHOOL
`1996-98
`Futility of Care Task Force, Harvard Medical School
`1999
`Search Committee, Chief of Pediatric Pulmonary Medicine, Children's Hospital, Boston, MA
`Ad Hoc Evaluation Committee for Professorial Promotion
`2005-07
`
`CHILDREN'S HOSPITAL. BOSTON
`1988-93
`Multidisciplinary Intensive Care Committee
`1989-90
`Chairman, Hospital Task Force on Sedation
`1990-92
`Hospital HMO Committee
`1991-92
`Medical Staff Quality Improvement Committee
`1991-93
`Department Quality Improvement Officer
`1991
`Hospital Review Committee for Department of Clinical Laboratories
`1992
`Chairman, Nominating Committee, Medical Staff Association
`1992-99
`Chairman, Special Care Units Committee
`1992
`Hospital Search Committee for Director of Clinical Laboratories
`Physician Advisory Committee on Computers
`1992
`1992
`Operations Improvement Committee
`1993
`Hospital Search Committee for MICU Director
`1993-01
`Cardiovascular Program, Quality Improvement Committee
`1996-98
`Product Standardization Council
`1998-01
`Planning and execution committee for ICU electronic clinical information system
`1998-01
`Clinical Oversight Committee for Transport
`2000
`Nominating Committee, Physician's Organization
`2000-02
`Chairman, Pharmacy and Therapeutics Committee
`Hospital Task Force on Clinical Building and New Construction
`2000-02
`2000-06
`ICU Committee
`2004-05
`Committee on Pension Investments, Physicians' Organization
`2004-07
`Quality and Outcomes Measurement, Physicians' Organization
`2005-07
`Program for Patient Safety and Quality Implementation Committee
`2006
`Hospital Search Committee for Non-invasive Cardiology Division Chief
`2006-07
`Hospital Peer Review Panel
`2006-07
`Physician Profile Task Force
`
`Ex. 2007-0807
`
`

`
`Wessel
`
`Page 5 of 39
`
`DEPARTMENT OF CARDIOLOGY. CHILDREN'S HOSPITAL, BOSTON
`1988-01
`Fellowship Selection Committee
`1998-02
`Audit and Finance Committee
`1998-02
`Computing Committee
`2004-05
`Audit and Finance Committee
`
`CHILDREN'S NATIONAL MEDICAL CENTER. WASHINGTON DC
`2007-09
`Facilities Leadership Committee
`2007-
`Growth Management/ CARE
`2007-
`NICU Steering Committee
`2007-
`Quality and Clinical Effectiveness Committee
`2007-
`Quality and Safety Council
`2007-
`Information Technology Oversight Committee
`2007-09
`CTI Clinical Advisory Council (electronic medical record)
`2007-
`Task Force on Access/Referral
`2007-08
`Hospital Search Committee for Cardiology Division Chief
`2007-
`Safety Transformation Advisory Council
`2009-
`Executive Oversight Committee (post graduate education)
`2009-
`Physicians Advisory Committee (third party payor contracts)
`2011-
`Physician Productivity Committee (Chair)
`Internal Advisory Board, GWU I CNMC, for NIH funded CTSI Award (Chair)
`2011-
`
`2008-
`
`NATIONAL & INTERNATIONAL
`1995
`Clinical Trials Review Committee (Ad hoc reviewer), National Institutes of Health
`1995-98
`Invited Speaker, Cardio-renal Advisory Panel, U.S. Food and Drug Administration
`2004-06
`Task Force ACC AHA AAP: Requirements for Pediatric Cardiac Critical Care Training
`2005-06
`Multi-Societal Committee (PCICSIEACTSISTS) Complications in Pediatric and Congenital
`Cardiac Surgery Project
`National Institute of Allergy and Infectious Disease Transplant Data and Safety Monitoring Board
`(DSMB) - Member
`FDA Invited Speaker, Continuing Education Series
`International Liaison Committee on Resuscitation (ILCOR): 201 0 Consensus Statement and
`Treatment Recommendations.
`Joint American Heart Association (AHA) -American Thoracic Society Expert Guidelines Statement
`on Pediatric Pulmonary Hypertension.
`
`2010
`2010
`
`2011
`
`INDUSTRY
`1994-97
`1998-02
`1999-01
`
`2001-06
`2001-02
`2001-03
`2001-09
`2003
`2005-07
`
`2005-07
`2005-07
`2006-
`
`2009
`
`Scientific Advisory Board on Nitric Oxide, Ohmeda Pharmaceuticals
`Curriculum Development Committee, INO Therapeutics
`Steering Committee, Prophylactic use of Primacor® in pediatric patients at high risk of developing
`low cardiac output syndrome following cardiac surgery. PRIMACORP study-Prophylactic
`intravenous use of milrinone after cardiac operation in pediatrics. Sanofi-Synthelabo Inc.
`Chairman, Advisory PaneiiNOTherapeutics
`Scientific Advisory Board AGA-Linde
`Protocol Planning Committee (POE V inhibitors) Pfizer
`Scientific Advisory Board for pulmonary hypertension research development, Pfizer
`Steering Committee for Multicenter Trial on Diagnostic Use of Inhaled Nitric Oxide
`Steering Committee for Multicenter Trial on Use of Nesiritide in Children, SCIOS (Johnson &
`Johnson)
`Advisory Committee on lloprost and Treatment of Pulmonary Hypertension in Children, Cotherix
`Advisory Board, Eli Lily Vardenafil for Pediatric Pulmonary Hypertension
`Steering Committee (Chairman) for Multicenter Trial on Use of Clopidogrel in Children (CLARINET),
`Bristol-Myers Squibb & Sanofi-Aventis
`Advisory Panel, Nesiritide Use in Pediatric Cardiovascular patients, Johnson & Johnson
`
`Ex. 2007-0808
`
`

`
`Wessel
`
`Page 6 of 39
`
`COMMUNITY SERVICE RELATED TO PROFESSIONAL WORK:
`1994-97
`Lecturer, Human Body Curriculum, Wellesley Public School System, Wellesley, MA
`1996
`Hospital Spokesman, Boston/Filenes' Holiday Festival
`Campaign for William & Mary, 25th Anniversary Committee
`1996
`2000-02
`Hospital Spokesman, Capital Campaign and Children's Hospital Boston Fundraising, including keynote
`speaker, 2000
`Multiple CNMC Fundraising and Community Benefit Events, presentations to Emeritus and Lady Visitor
`Boards, etc.
`Speaker, CNMC Corporate Leadership Council "What's Up, Doc?" Breakfast, World Bank, Washington,
`D.C.
`
`2007-
`
`2008
`
`EDITORIAL BOARDS/REVIEW COMMITTEES:
`Ad Hoc Reviewer:
`Acta Pediatrics
`American Journal of Cardiology, American Journal of Physiology
`American Review of Respiratory Diseases and Critical Care
`Anesthesia & Analgesia, Anesthesiology
`Annals of Thoracic Surgery
`Archives of Diseases of Childhood
`Cardiovascular and Interventions I Radiology
`Chest
`Circulation
`Critical Care Medicine
`European Heart Journal
`Future Cardiology
`Journal of Intensive Care Medicine
`Journal of Pediatrics
`Journal of Thoracic and Cardiovascular Surgery
`Mayo Clinic Proceedings
`Pediatrics, Pediatric Cardiology, Pediatric Critical Care Medicine, Pediatric Research
`Proceedings of the National Academy of Science
`
`Invited consultant, to review and make recommendations to institutional programs for pediatric cardiovascular care
`(national and international)
`
`Asked by Children's Hospital Boston to chair ad hoc committees reviewing sentinel events, other critical incidents and
`report the hospital's analysis and action to the Hospital's Board of Trustees, JCAHO, etc.
`
`7) EDUCATIONAL ACHIEVEMENTS
`
`REPORT OF TEACHING
`1.
`LOCAL CONTRIBUTIONS
`a) MEDICAL SCHOOL
`Yale University School of Medicine, New Haven, CT
`1975-76 Program leader, Cardiovascular physiology core lectures in Physician's Associate Program
`Designed lecture series for new PA program: 20 hours/year
`
`Harvard Medical School, Boston, MA
`
`1983-98
`
`Instructor, Cardiovascular Physiology Animal Laboratory, Harvard Medical School
`Approximately 60 medical students; one day per year
`1985-89 Cardiovascular Pathophysiology, Laboratory section on congenital heart disease
`Approximately 30 medical students; half day per year
`
`Ex. 2007-0809
`
`

`
`Wessel
`
`Page 7 of 39
`
`1985-89 PGY clerkship in Pediatrics
`Lecturer in Critical Care (Multidisciplinary ICU)
`2 medical students each lecture; 12 hours/year
`
`b) GRADUATE MEDICAL EDUCATION (LOCAL)
`1985-89 Didactic seminars on cardiovascular pathophysiology for pediatric critical care fellows and
`rotating residents
`Lecture once per week, 1 hour, 6 trainees per lecture
`1986-93 Developed and taught core curriculum: introduction to anesthesia and critical care for
`cardiologists
`Lecture once per week, 1 hour, six weeks, 20 fellows and junior faculty. Preparation, 40 hours
`per year
`1985-89 Co-developed tutorials on congenital heart disease and supervised core staff (3 tutors) for
`instruction of cardiology and cardiac ICU fellows during ICU rotation
`Lectures three mornings per week, 1/2 hour, 3-4 fellows; preparation, 2 hours per week
`
`1985-07 CICU attending rounds
`3 pediatric residents (1985-1989), 4-8 fellows and senior surgical residents; 18 hours/week,
`16-40 weeks/year (varies with year)
`
`1990-96 Chiefs' Ward Rounds
`3 medical students, 3 pediatric residents, 1 cardiology fellow; monthly 12 hours/year
`
`1996-07 Didactic lectures to cardiology fellows teaching program
`20 fellows 3 times per year
`2002-03 Didactic lectures (monthly) to trainees at Royal Brompton Hospital. London
`
`c) BOSTON INVITED TEACHING PRESENTATIONS (SELECTED)
`1984
`Anesthesia Grand Rounds, Children's Hospital, Boston, MA
`1991
`Anesthesia Grand Rounds, Children's Hospital, Boston, MA
`1992 Surgical Grand Rounds, Children's Hospital, Boston, MA
`1992 Medical Grand Rounds, Children's Hospital, Boston, MA
`1994 Anesthesia Grand Rounds, Children's Hospital, Boston, MA
`1996 Anesthesia Grand Rounds, Massachusetts General Hospital, Boston, MA
`1996 PICU Teaching Sessions, Massachusetts General Hospital, Boston, MA
`1997 Surgical Grand Rounds, Children's Hospital, Boston, MA
`1997 Medical Grand Rounds, Children's Hospital, Boston, MA
`1998 Anesthesia Grand Rounds, Children's Hospital, Boston, MA
`2003 Grand Rounds and teaching rounds, Royal Brompton Hospital, London, UK
`2004 Neonatology Clinical Working Group, Children's Hospital, Boston, MA
`2004 Department of Respiratory Therapy Clinical Working Group, Children's Hospital, Boston, MA
`2005 Department of Cardiology, Didactic Series, Children's Hospital Boston, Boston, MA
`
`d) WASHINGTON DC AREA INVITED TEACHING PRESENTATIONS (SELECTED)
`• Chief Rounds Monthly to ICU & Cardiology fellows and staff (15-20 physicians, 2hrs/month), CNMC, DC
`•
`ICU Attending Rounds, Children's National Medical Center, DC
`• Clinical Research Presentation to ICUICardiology Fellows 2 times per year, Children's National Medical
`Center, DC
`• Grand Rounds, Children's National Medical Center, DC
`• Grand Rounds, Mary Washington Hospital, VA
`• Grand Rounds, Anne Arundel Medical Center, MD
`• Teaching Rounds, Division of Critical Care Medicine, National Institutes of Health
`
`Ex. 2007-0810
`
`

`
`Wessel
`
`Page 8 of 39
`
`e) CONTINUING MEDICAL EDUCATION (LOCAL)
`1988
`Lecturer
`Harvard Medical School, Continuing Education Course in Pediatric Anesthesia
`"Anesthesia for Congenital Heart Disease"
`
`1990
`
`1989
`
`1993
`
`1996
`
`1998
`
`1999
`
`2001
`
`Lecturer
`Harvard Medical School Continuing Education Course in Pediatric Anesthesia
`"Common Congenital Cardiac Lesions"
`
`Moderator
`Harvard Medical School, Continuing Education Course in Pediatric Cardiovascular Disease
`
`Lecturer
`Symposium on Brain Injury and Cardiac Surgery, Harvard Medical School, Boston, MA
`"Choreoathetosis After Cardiopulmonary Bypass"
`
`Lecturer
`Harvard Medical School Continuing Education Course in Pediatric Anesthesia
`"New Vasoactive Drugs"
`
`Co-director, First Annual Course: Frontiers in the Diagnosis and Management of Congenital
`Heart Disease, Children's Hospital, Boston, Harvard Medical School, Boston, MA
`
`Co-director, Second Annual Course: Frontiers in the Diagnosis and Management of
`Congenital Heart Disease, Children's Hospital, Boston, Newport, Rhode Island
`
`Co-director, Third Annual Course: Frontiers in the Diagnosis and Management of Congenital
`Heart Disease, Children's Hospital, Boston, Newport, Rhode Island
`
`f) ADVISORY AND SUPERVISORY RESPONSIBILITIES (LOCAL)
`1987-
`Responsible for clinical supervision and educational component of critical care for cardiology
`fellows in a large pediatric cardiology training program (two months each year for each of 18
`fellows spread over 2-3 years of training).
`
`1990-02 Responsible as mentor for clinical, educational and clinical research activities of 2-3 senior
`clinical fellows each year.
`
`1985-
`
`Shared responsibilities for cardiovascular education and clinical supervision of pediatric critical
`care fellows in the CICU (3-5 months per year for 5-6 fellows spread over 2-3 years of
`training).
`
`1985-02 Shared responsibilities for critical care educational component of pediatric cardiovascular
`surgical training program (1 0 surgical residents each year rotating for 6 months each).
`1987-02 Responsible for medical education and clinical advisory tasks for continuing education
`seminars for 80 critical care nurses.
`g) LEADERSHIP ROLE (LOCAL)
`1998-01 Program Co-Director
`Annual Course, "Frontiers in Diagnosis and Management of Congenital Heart Disease" Shared
`responsibility for organizing and executing post graduate course attended by 200 pediatric
`cardiologists cardiovascular surgeons and nurses from the US and abroad.
`
`Ex. 2007-0811
`
`

`
`Wessel
`
`Page 9 of 39
`
`h) NAMES OF SELECTED TRAINEES AND/OR FORMER CICU STAFF WHO HAVE CURRENT LEADERSHIP POSITIONS
`1985-88 Gil Wernovsky, MD, FACC *t§
`Director of Program Development
`Former Director, Cardiac Intensive Care Unit
`The Children's Hospital of Philadelphia
`Professor of Pediatrics
`University of Pennsylvania School of Medicine
`Philadelphia, Pennsylvania
`1988-89 Ling Chen, MD *
`Director, Cardiac Intensive Care Unit
`Shanghai Children's Medical Center
`Shanghai, China
`
`1989-92 Pierre C. Wong, MD *t
`Cardiology Medical Director, Transplantation
`Children's Hospital of Los Angeles
`Los Angeles, California
`
`1989-92 Stephen J. Roth, MD, MPH *t
`Director, Cardiac Intensive Care Unit
`Lucile Packard Children's Hospital
`Associate Professor of Pediatrics
`Stanford University School of Medicine
`Palo Alto, California
`
`1989-92 Nancy Bridges, MD
`Chief, Transplantation Immunology Branch, Division of Allergy, Immunology, and
`Transplantation
`National Institute of Allergy and Infectious Disease
`Bethesda, Maryland
`
`1990-92 Howard A. Zucker, MD, FACC*
`Deputy Director of the World Health Organization
`Geneva, Switzerland
`
`1990-93 Kevin B. Churchwell, MD
`Chief Executive Officer (CEO) for Nemours/Alfred I. duPont Hospital for Children
`Wilmington, DE.
`
`1990-93 Anthony C. Chang, MD *t§
`Medical Director, CHOC Children's Heart Institute
`Children's Hospital Orange County
`Orange, California
`
`1991-94 Jan Adatia, MB, ChB, MRCP (UK), FRCP (C) *t
`Director, Pediatric Cardiac Critical and Intermediate Care Program,
`Director, Pediatric Pulmonary Hypertension Clinic,
`Stollery Children's Hospital,
`Professor of Pediatrics
`University of Alberta
`Edmonton, Alberta, Canada
`
`Ex. 2007-0812
`
`

`
`Wessel
`
`Page 10 of 39
`
`1992-96 Andrew M. Atz, MD *t§
`Director, Pediatric Cardiac Intensive Care Unit
`The Children's Heart Program
`Associate Professor of Pediatrics
`Medical University of South Carolina
`Charleston, South Carolina
`
`1992-96 David P. Nelson, MD, PhD*
`Director, Cardiac Intensive Care
`Cincinnati Children's Hospital Medical Center
`Professor of Pediatrics
`Cincinnati, Ohio
`
`1992-97 Sarah Tabbutt, MD, PhD*
`Director, Pediatric Cardiac Intensive Care Unit
`UCSF Children's Hospital
`San Francisco, California
`
`1994-97 Ricardo A. Murioz, MD *t§
`Director, Pediatric Cardiac Intensive Care
`Director, Global Business and Telemedicine
`Children's Hospital Pittsburgh
`Associate Professor of Pediatrics
`University of Pittsburgh
`Pittsburgh, Pennsylvania
`
`1994-99 Melvin C. Almodovar, MD *t§
`Medical Director, Cardiac Intensive Care Unit
`Boston Children's Hospital
`Assistant Professor
`Harvard Medical School
`Boston, Massachusetts
`
`1995-96 Brendan O'Hare, MD *
`Consultant in Anesthesia and Critical Care
`Our Lady's Hospital for Sick Children
`Crumlin, Dublin, Ireland
`
`1995-96-Steven Schwartz, MD
`Director of Cardiac Intensive Care
`Hospital for Sick Children
`Assistant Professor of Pediatrics
`University of Toronto
`Toronto, Ontario, Canada
`
`1996-97 Alain Fraisse, MD *t
`Chief, Clinical Pediatric Cardiology
`Hopital D'Enfants de Ia Timone
`Professer of Pediatrics
`Universitaire de Marseille
`Marseille, France
`
`Ex. 2007-0813
`
`

`
`Wessel
`
`Page 11 of 39
`
`1997-98 Guillermo Palacio, MD
`Director Pediatric Cardiac Intensive Care Unit
`Fundacion Cardio lnfantil
`Bogota, Colombia
`
`1997-98 Mary B. Taylor, MD*
`Director, Pediatric Cardiac Critical Care
`Cardiology and Critical Care
`Vanderbilt Children's Hospital
`Associate Professor of Pediatrics
`Vanderbilt University Medical Center
`Nashville, Tennessee
`
`1997-99 Rajiv Chaturvedi, MB BChir, MRCP (UK), MD*
`Pediatric Cardiology
`Hospital for Sick Children
`Assistant Professor
`University of Toronto
`Toronto, Ontario, Canada
`1998-01 Ravi Thiagarajan, M.D.* t §
`Director, Cardiac ECMO Program
`Children's Hospital Boston
`Associate Professor of Pediatrics
`Harvard Medical School
`Boston, Massachusetts
`
`1998-02 Peter C. Laussen, MBBS §
`Chief, Division of Cardiovascular Intensive Care
`D.O. Hansen Chair in Pediatric Anesthesia
`Senior Associate in Cardiology
`Children's Hospital Boston
`Professor of Anesthesia
`Harvard Medical School
`Boston, Massachusetts
`
`1998-99 Mary P. Mullen, MD, PhD*§
`Director, Pulmonary Hypertension Program
`Assistant in Cardiology
`Children's Hospital Boston
`Assistant Professor in Pediatrics
`Harvard Medical School
`Boston, Massachusetts
`
`1999
`
`2000
`
`Janet M. Simsic, M.D.*
`Director, Pediatric Cardiac Intensive Care Unit
`Nationwide Children's Hospital
`Columbus, Ohio
`
`Erica A. Kirsch, MD*
`Director of Pediatric ECMO Program
`Associate Professor of Pediatrics
`University of Missouri-Kansas City School of Medicine
`Kansas City, Missouri
`
`Ex. 2007-0814
`
`

`
`Wessel
`
`Page 12 of 39
`
`2003-05 Margarita Burmester, MBBS* t
`Consultant in Pediatric Intensive Care
`Royal Brompton Hospital
`Imperial College
`London, United Kingdom
`
`* Clinical Trainees
`t Research Trainees
`§ Faculty in CICU, Children's Hospital Boston
`during my tenure as Chief
`
`TEACHING AND EDUCATIONAL LEADERSHIP ROLES (LOCAL AND INTERNATIONAL)
`1987
`Critical Care Consultant for Project Hope and the Cardiac Intensive Care Unit, Xin Hua,
`Shanghai, China. Developed teaching program for critical care and supervised clinical training of
`physicians during 2-Smonth exchange programs.
`
`1996-
`
`Abstract and Program Reviewer for many National and International Societies including
`SPR, AHA, ACC, PCICS, World Congress
`
`2000
`
`2002
`
`2003
`
`2004
`
`Invited faculty and cardiovascular program curriculum track convener
`Ill International Congress of Pediatric Intensive Care, Montreal, Canada.
`
`Scientific Programme, Coordinator
`The Third Special Topics in Paediatric Cardiac Intensive Care, The Failing Myocardium
`Royal Brompton Hospital, Imperial College, London, United Kingdom
`
`Invited faculty and cardiovascular program curriculum track convener
`IV International Congress of Pediatric Intensive Care, Boston, MA
`
`Discussant Leader and Co-author (after Tom Kulik) on Critical Care Training Guidelines in
`Cardiology (SCCM, PCICS, AHA, ACC)
`
`2005 Scientific Program Committee Pediatric Cardiac Intensive Care Symposium 2005 (PCICS 2005),
`Miami, FL
`
`2006
`
`Planning Committee, First International Conference on Childhood Pulmonary Vascular
`Disease, San Francisco, CA 2007
`
`2008
`
`Critical Care Consultant, University of Mississippi Medical Center, Jackson, MS
`
`TEACHING AWARD(S) RECEIVED
`1996 Faculty Teaching Award, Dept. Cardiology, Child

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