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Full text of "USPTO Patents Application 09919224"

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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