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Thomas J. Schall et al. 
Application No.: 09/919,224 
Page 5 



PATENT 



IN THE CLAIMS: 

Please amend the following claims as indicated without prejudice or disclaime r: 

21 . (Once amended) A therapeutic or prophylactic method for treating an 
immune disorder, comprising: 

administering to a patient suffering from or susceptible to the immune disorder a 
pharmaceutically acceptable dose of rhesus CMV IL-10. 

22. (Once amended) The method of claim 21, wherein the rhesus CMV IL-10 
is a component of a pharmaceutical composition further comprising a pharmaceutically 
acceptable carrier. 

23. (Once amended) The method of claim 22, wherein the pharmaceutical 
composition is sterile, substantially isotonic and prepared under GMP conditions. 

24. (Once amended) The method of claim 21, wherein the immune disorder is 
selected from the group consisting of graft-versus-host disease, an autoimmune disease, an 
inflammatory response, a pathologic delayed type hypersensitivity response, endotoxin-induced 
toxic shock, granulomatis disease, psoriasis, uveitis, systemic lupus erythematous, multiple 
sclerosis and contact-dermatitis. 

25. (Once amended) The method of claim 50, further comprising monitoring 
proliferation of lymphocytes in the patient to detect a reduction in the level of lymphocyte 
proliferation responsive to the administering step. 

26. (Once amended) The method of claim 21, further comprising monitoring 
a symptom of the patient to detect amelioration of the symptom responsive to the administering 
step. 

27. (Once amended) The method of claim 21, wherein the patient is suffering 
from the disorder and the method is a therapeutic treatment method. 



Thomas J. Schall et al. PATENT 
Application No.: 09/919,224 
Page 6 

r 28. (Once amended) The method of claim 21, wherein the patient is 

\Jr^ susceptible to the disorder and the method is a prophylactic treatment method. 



3 1 . (Once amended) The method of claim 30, wherein IFN-a levels of the 
patient are detectably decreased responsive to the administering of rhesus CMV IL-10. 

32. (Once amended) The method of claim 21, wherein the immune disorder is 
\ ^ a chronic inflammatory disease. 



33. (Once amended) The method of claim 32, wherein the chronic 
inflammatory disease is selected from the group consisting of rheumatoid arthritis, inflammatory 
bowel disease, Crohn's disease, ulcerative colitis, Graves' disease, Hashimoto's thyroiditis, 
systemic lupus erythematosus, multiple sclerosis, scleroderma, and insulin-dependent diabetes 
mellitus. 

34. (Once amended) The method of claim 21, wherein the immune disorder is 
an allergic response. 

35. (Once amended) The method of claim 34, wherein the immune disorder is 

asthma. 

36. (Once amended) The method of claim 21, wherein the patient is suffering 
from a type TH1 immune response to a transplanted graft. 

A 38. (Once amended) The method of claim 25, wherein the immune disorder is 

ft, 

* f leukemia. 



44. (Once amended) A therapeutic or prophylactic method for treating an 
inflammatory response, comprising administering to a patient suffering from or susceptible to the 
inflammatory response a pharmaceutically acceptable dose of rhesus CMV IL-10. 



Thomas J. Schall et al. PATENT 
Application No.: 09/919,224 
Page 7 

45. (Once amended) The method of claim 44, further comprising monitoring 
proliferation of leukocytes in the patient to detect a reduction in the level of leukocyte 
proliferation responsive to the administering step. 

46. (Once amended) The method of claim 44, further comprising monitoring 
a symptom of the patient to detect amelioration of the symptom responsive to the administering 
step. 

47. (Once amended) The method of claim 44, wherein the patient is suffering 
from the disorder and the method is a therapeutic method. 

48. (Once amended) The method of claim 44, wherein the inflammatory 
response is a chronic inflammatory disease. 

49. (Once amended) The method of claim 48, wherein the chronic 
inflammatory disease is selected from the group consisting of rheumatoid arthritis, Crohn f s 
disease, ulcerative colitis, Graves 1 disease, Hashimoto's thyroiditis and insulin-dependent 
diabetes mellitus. . . 

Please add the following new claims: 

50. (New) The method of claim 21, wherein the patient is a human. 

5 1 . (New) The method of claim 21, wherein the pharmaceutically acceptable 
dose is administered as a single dose. 

52. (New) The method of claim 21, wherein the pharmaceutically acceptable 
dose is administered as part of a multi-dose regime. 



53. (New) The method of claim 50, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit proliferation of leukocytes in the human patient. 



Thomas J. Schall et al. PATENT 
Application No.: 09/919,224 
Page 8 

54. (New) The method of claim 50, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit proliferation of peripheral blood mononuclear 
cells in the peripheral blood of the human patient. 

55. (New) The method of claim 50, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit cytokine production in the human patient. 

56. (New) The method of claim 44, wherein the patient is susceptible to the 
inflammatory response and the method is a prophylactic treatment method. 

57. (New) The method of claim 44, wherein the patient is a human. 

58. (New) The method of claim 44, wherein the pharmaceutically acceptable 
dose is administered as a single dose. 

59. (New) The method of claim 44, wherein the pharmaceutically acceptable 
dose is administered as part of a multi-dose regime. 

60. (New) The method of claim 57, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit proliferation of peripheral blood mononuclear 
cells in the peripheral blood of the human patient. 

61 . (New) The method of claim 57, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit cytokine production in the human patient. 



RESPONSE TO RESTRICTION REQUIREMENT 

In response to the Restriction Requirement, Applicants elect to prosecute without 
traverse the claims of Group V, specifically claims 21-38 and 44-49 involving administration of 
rhesus CMV IL-10 to treat certain disorders. New claims 50-61 fall within this elected group. 



Thomas J. Schall et al. 
Application No.: 09/919,224 
Page 13 



PATENT 



Murine Model for Graft V e rs e s Host Graft -Versus-Host Disease 
IN THE CLAIMS: 

Claims 21-28, 31-36, 38 and 44-49 have been amended as follows without 
prejudice or disclaimer: 

2 1 . (Once amended) A therapeutic or prophylactic method of pr e v e nting or 
for treating an immune disorde r in a pati e nt , comprising: 

administering rh e sus CMV IL10 or human CMV IL 10 to a patient suffering 
from or susceptible to the immune disorder in a dosag e suffici e nt to inhibit prolif e ration of 
lymphocyt e s in th e pati e nt, and ther e by pr e v e nt or tr e at th e disord e r a pharmaceuticallv 
acceptable dose of rhesus CMV IL-10 . 

22. (Once amended) The method of claim 21, wherein the rhesus CMV IL-10 
or human CMV IL 10 is a component of a pharmaceutical composition further comprising a 
pharmaceutically acceptable carrier. 

23 . (Once amended) The method of claim 24- 22, wherein the pharmaceutical 
composition is sterile, substantially isotonic and prepared under GMP conditions. 

24. (Once amended) The method of claim 21, wherein the pati e nt is suffering 
from or susc e ptibl e to an immune disorder is selected from the group consisting of graft v e rsus 
host graft-versus-host disease, an autoimmune disease, an inflammatory response, a pathologic 
delayed type hypersensitivity response, endotoxin-induced toxic shock, granulomatis disease, 
psoriasis, uveitis, systemic lupus erythematous, multiple sclerosis and contact-dermatitis. 

25. (Once amended) The method of claim 24- 50, further comprising 
monitoring proliferation of the lymphocytes in the patient to detect a reduction in the level of 
lymphocyte proliferation responsive to the administering step. 



Thomas J. Schall et al. PATENT 
Application No.: 09/919,224 
Page 14 

26. (Once amended) The method of claim 21, further comprising monitoring 
a symptom of the patient, patient to detect amelioration or pr e v e ntion of the symptom responsive 
to the administering step. 

27. (Once amended) The method of claim 21, wherein the patient is suffering 
from the disorder and the method is a therapeutic treatment method . 

28. (Once amended) The method of claim 21, wherein the patient is 
susceptible to the disorder and the method is a prophylactic treatment method . 

3 1 . (Once amended) The method of claim 30, wherein the IFN-a levels of the 
patient are detectably decreased responsive to the administering of rhesus or human CMV IL-10. 

32. (Once amended) The method of claim 2 1 , wherein the inflammatory 
immune disorder is a chronic inflammatory r e spons e disease . 

33. (Once amended) The method of claim 32 3Z, wherein the chronic 
inflammatory disease is selected from the group consisting of rheumatoid arthritis, inflammatory 
bowel disease, Crohn's disease, ulcerative colitis, Graves' disease, Hashimoto's thyroiditis, 
systemic lupus erythematosus, multiple sclerosis, scleroderma, and insulin-dependent diabetes 
mellitus. 

34. (Once amended) The method of claim 21, wherein the inflammatory 
immune disorder is an allergic response. 

35. (Once amended) The method of claim 34, wherein the inflammatory 
immune disorder is asthma. 

36. (Once amended) The method of claim 21, wherein the patient is suffering 
from a type TH1 immune response to a transplanted graft. 



38. (Once amended) The method of claim 2$ 25^ wherein the immune 
disorder is leukemia. 



Thomas J. Schall et al. PATENT 
Application No.: 09/919,224 
Page 15 

44. (Once amended) A therapeutic or prophylactic method of pr e v e nting or 
for treating the symptoms of an inflammatory response, comprising administering rhesus CMV 
IL 10 or human CMV IL 10 to th e to a patient suffering from or susceptible to an the 
inflammatory response in a dosag e suffici e nt to am e liorat e at l e ast som e of th e symptoms of th e 
inflammatory condition a pharmaceuticallv acceptable dose of rhesus CMV IL-10 . 

45. (Once amended) The method of claim 44, further comprising monitoring 
proliferation of th e lymphocyt e s leukocytes in the patient to detect a reduction in the level of 
leukocyte proliferation responsive to the administering step. 

46. (Once amended) The method of claim 44, further comprising monitoring 
a symptom of the pati e nt, patient to detect amelioration or pr e v e ntion of the symptom responsive 
to the administering step. 

47. (Once amended) The method of claim 44, wherein the patient is suffering 
from the disorder and the method is a therapeutic method . 

48. (Once amended) The method of claim 44 44^ wherein the inflammatory 
response is a chronic inflammatory r e spons e disease . 

49. (Once amended) The method of claim 48 4^ wherein the chronic 
inflammatory disease is selected from the group consisting of rheumatoid arthritis, Crohn's 
disease, ulcerative colitis, Graves' disease, Hashimoto's thyroiditis and insulin-dependent 
diabetes mellitus. 

New claims 50-61 have been added follows: 

50. (New) The method of claim 21, wherein the patient is a human. 

5 1 . (New) The method of claim 2 1 , wherein the pharmaceutical^ acceptable 
dose is administered as a single dose. 



Thomas J. Schall et al. PATENT 
Application No.: 09/919,224 
Page 16 

52. (New) The method of claim 21, wherein the pharmaceutically acceptable 
dose is administered as part of a multi-dose regime. 

53. (New) The method of claim 50, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit proliferation of leukocytes in the human patient. 

54. (New) The method of claim 50, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit proliferation of peripheral blood mononuclear 
cells in the peripheral blood of the human patient. 

55. (New) The method of claim 50, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit cytokine production in the human patient. 

56. (New) The method of claim 44, wherein the patient is susceptible to the 
inflammatory response and the method is a prophylactic treatment method. 

57. (New) The method of claim 44, wherein the patient is a human. 

58. (New) The method of claim 44, wherein the pharmaceutically acceptable 
dose is administered as a single dose. 

59. (New) The method of claim 44, wherein the pharmaceutically acceptable 
dose is administered as part of a multi-dose regime. 

60. (New) The method of claim 57, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit proliferation of peripheral blood mononuclear 
cells in the peripheral blood of the human patient. 

61 . (New) The method of claim 57, wherein rhesus CMV IL-10 is 
administered in an amount sufficient to inhibit cytokine production in the human patient.