PTO/SB/08A (08-03)
Substitute for form 1449A/PTO
INFORMATION DISCLOSURE
STATEMENT BY APPLICANT
(use as many sheets as necessary)
Complete if Known
Application Number
09/919,224
Filing Date
July 30, 2001
First Named Inventor
Schall, Thomas J.
Art Unit
1644
Examiner Name
Michail A. Belyavskyi
Sheet | 1 | of | 3
Attorney Docket Number
019934-001710US
U.S. PATENT DOCUMENTS*
Document Number
Publication Date
MM-DD-YYYY
Name of Patentee or
Applicant of Cited Document
Pages, Columns, Lines. Where
Relevant Passages or Relevant
Figures Appear
Examiner
Initials*
Cite
No. 1
Number Kind Code 1 (if known)
A*
A1
US-5,770,190
06-23-1998
Bruserud et al.
A2
US-5,833,976
11-10-1998
Malefyt et al.
A3
US-5,866,134
02-02-1999
Fine et al.
A4
US-5,871 f 725
02-16-1999
Schwarz
h
A5
US-6.022,536
02-08-2000
Tadmori
A6
FOREIGN PATENT DOCUMENTS
Examiner
Initials 4
Cite
No. 1
Foreign Patent Document
Publication Date
MM-DD-YYYY
Name of Patentee or
Applicant of Cited
Document
Pages. Columns, Lines.
Where Relevant
Passages or Relevant
Country Code 3 N um ber 4 Kind Coda* (tf known)
B1
n
B2
n
B3
n
?/2
EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant. 1 Applicant's unique citation designation number (optional). 2
Kind Codes of U.S. Patent Documents at www.uso1o.qov or MPEP 901.04. * Enter Office that issued the document, by the two-letter code (WIPO
Standard ST.3). For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent
document. Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST. 16 if possible. 8 Applicant is to
place a check mark here if English language Translation is attached
60236538 v1
Examiner
Signature
Considered
PTO/SB/08B (08-03)
Substitute for form 1449B/PTO
INFORMATION DISCLOSURE
STATEMENT BY APPLICANT
(use as many sheets as necessary)
Complete if Known
Application Number
09/919,224
Filing Date
July 30, 2001
First Named Inventor
Schall, Thomas J.
Art Unit
1644
Examiner Name
Michail A. Belyavskyi
Sheet | 2 of 3
Attorney Docket Number
019934-001710US
NON PATENT LITERATURE DOCUMENTS
Examiner
Initials *
Cite
No. 1
Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
publisher, city and/or country where published.
T 2
nif>
C1
ASADULLAH, KHUSRU et al. "Interieukin-10 Therapy- Review of a New Approach" Pharmachological Reviews,
2003, pp. 241-269, Vol. 55, No. 2.
C2
ASADULLAH, KHUSRU et al. "Interleukin 10 Treatment of Psoriasis" Arch. Dermatol, Feb. 1999, pp. 187-192, Vol.
135.
C3
ASADULLAH, KHUSRU et al. "IL-10 Is a Key Cytokine in Psoriasis" J. Clin. Invest., Feb. 1998, pp. 783-794, Vol.
101, No. 4.
C4
DEJACO, C, et al. "In Vivo Effects of Recombinant Human Interieukin-10 on Lymphocyte Phenotypes and
Leukocyte Activation Markers in Inflammatory Bowel Disease" J. Investigative Medicine, Nov. 2000, pp. 449-456,
Vol. 48, No. 6.
C5
DHARANCY, SEBASTIEN et al. "Hepatic Deficiency of Interleukin 10 in Chronic Hepatitis C Gastroenterology,
1000, pp. 1411-1420, Vol. 119.
C6
FEDORAK, RICHARD N. et al. "Recombinant Human Interleukin 10 in the Treatment of Patients With Mild to
Moderately Active Crohn's Disease" Gastroenterology. 2000, pp. 1473-1482, Vol. 119.
C7
FRIEDRICH, MARKUS et al. "Immunomodulation by lnterteukin-10 Therapy Decreases the Incidence of Relapse
and Prolongs the Relapse-free Interval in Psoriasis" J, Investigative Dermatology. April 2002, pp. 672-677, Vol. 118,
No. 4.
C8
GAS HE, CHRISTOPH et al. "IL-10 Secretion and Sensitivity in Normal Human Intestine and Inflammatory Bowel
Disease" J. Clin. Immunol., 2000, pp. 382-370, Vol. 20, No. 5.
C9
GASHE. CHRISTOPH et al. "Novel Variants of the IL-10 Receptor 1 Affect Inhibition of Monocyte TNF-a Production"
"J. Immunology. 2003, pp. 5578-5582, Vol. 170. No. 11.
C10
KEYSTONE, EDWARD et al. "IL-1 0 as a Therapeutic Strategy in the Treatment of Rheumatoid Arthritis" Emerging
Therapies for Rheumatoid Arthritis, Rheumatic Disease Clinics of North America, August 1998, pp. 629-639, Vol. 24,
No. 3.
C11
LINDSAY, J.O. & HODGSON, J.F. "Review Article: the immuno regulatory cytokine interieukin-10- a therapy for
Crohn's disease?" Aliment Pharmacol. Ther., 2001, pp. 1709-1716, Vol. 15.
C12
LLORENTE, LUIS et al. "Clinical and Biologic Effects of Anti-lnterleukin-1 0 Monoclonal Antibody Administration in
Systemic Lupus Erythematosus" Arthritis & Rheumatism. August 2000. pp. 1790-1800, Vol. 43, No. 8.
C13
MOCELLIN, SIMONE etal. "The dual role of IL-10" Trends in Immunology, Jan. 2003, pp. 38-43, Vol. 24, No. 1.
C14
MOORE. KEVIN et al. "Interieukin-10 and the lnterteukin-10 Receptor Annu. Rev. Immunol.. 2001. pp. 683-765,
Vol. 19.
C15
NELSON. DAVID R. et al. "Interieukin 10 Treatment Reduces Fibrosis in Patients With Chronic Hepatitis C: A Pilot
Trial of Interferon Non respond ers" Gastroenterology 2000; 1 18 655-660. Published online 10 March 2000.
r\r
C16
OPAL, STEVEN M. et a I. "Interieukin-10: Potential Benefits and Possible Risks in Clinical Infectious Diseases"
Clinical Infectious Diseases, 1998, pp. 1497-1507, Vol. 27.
EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not In conformance
and not considered. Include copy of this form with next communication to applicant
Applicant's unique citation designation number (optional). 1 Applicant is to place a check mark here if English language Translation is attached.
60236538 v1
PTO/SB/08B (08-03)
^^ifbstitute for form 1449B/PTO
INFORMATION DISCLOSURE
STATEMENT BY APPLICANT
(use as many sheets as necessary)
Complete if Known
Application Number
09/919,224
Filing Date
July 30, 2001
First Named Inventor
Schall, Thomas J.
Art Unit
1644
Examiner Name
Michail A. Belyavskyi
Sheet | 3 | of 3
Attorney Docket Number
01 9934-001 71 0US
NON PATENT LITERATURE DOCUMENTS
Examiner
Initials *
Cite
No. 1
Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue numbers),
publisher, city and/or country where published.
T 2
C17
OPAL, STEVEN M. & CROSS, ALAN S. "The Microbial Consequences of Antimediator Therapy for Sepsis" Sepsis,
1997, pp. 59-64, Vol. 1.
C18
SANDER, O. & RAU, R. "Clinical trials on biologies in rheumatoid arthritis" International J. of Clinical Pharmacology
and Therapeutics, 1998, pp. 621-624, Vol. 36, No. 11.
C19
SCHREIBER, STEFAN et al. "Immunoregulatory Role of Interieukin 10 in Patients With Inflammatory Bowel
Disease" Gastroenterology, 1995, pp. 1434-1444, Vol. 108.
C20
SCHREIBER, STEFAN et al. "Safety and Efficacy of Recombinant Human Interieukin 10 in Chronic Active Crohn's
Disease" Gastroenterology, 2000, pp. 1461-1472, Vol. 119.
C21
Stedman's Medical Dictionary, 26th Edition, 1990, Definition of "Symptom", p. 1718.
C22
STEINHART, HILLARY "Clinical perspectives- Biologies in IBD: What's all the fuss?" Can. J. Gastroenterology,
Dec 2001 , pp. 799-804, Vol. 1 5, No. 12.
C23
TILG, H, et al. Treatment of Crohn's disease with recombinant human interieukin 10 induces the proinflammatory
cytokine interferon f Gut, 2002, pp. 191-195, Vol. 50.
C24
VAN DER POLL. TOM et al. "Endogenous IL-10 Protects Mice from Death During Septic Peritonitis" J. Immunology,
1995, pp. 5397-5401. Vol. 155.
C25
VAN DEVENTER, SANDER J.H. et al. "Multiple Doses of Intravenous Interieukin 10 in Steroid-Refractory Crohn's
Disease" Gastroenterology, 1997, pp. 383-389, Vol. 113.
C26
WISSING. K. MARTIN et al. "A pilot trial of recombinant human interleukin-10 in kidney transplant recipients
receiving OKT3 induction therapy" Transplantation, Oct. 1997, pp. 999-1006, Vol. 64.
Examiner
Signature
EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant
1 Applicant's unique citation designation number (optional). 2 Applicant is to place a check mark here if English language Translation is attached.
60236538 v1
