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United States R\tenT and Trademark Office 



UNITED STATRS DEPARTMENT OF COMMERCE 
UnitoJ Stntnn Potnut and Trademark Offioo 
Artdrww COMMISSIONER OF PATENTS AND TRADEMARKS 
Washington, D.C. 20231 

WWW.URptO.gtKV 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



ATTORNEY DOCKET NO. 



CONFIRMATION NO. 



09/919,224 



07/30/2001 



Thomas J. Schall 



01 9934-001 7 10US 



5559 



20350 7590 10/01/2002 

TOWNSEND AND TOWNSEND AND CREW, LLP 
TWO EMBARCADERO CENTER 
EIGHTH FLOOR 

SAN FRANCISCO, CA 94111-3834 



BEGT COPY 



EXAMINER 



BELYAVSKYl, MICHAIL A 



ART UNIT 



PAPER NUMBER 



1644 

DATE MAILED: 10/01/2002 



Please find below and/or attached an Office communication concerning this application or proceeding. 



PTO-90C (Rev. 07-01) 



Office Action Summary 



Application No. ^^^0 

09/919,224 


Applicant(s) 
SCHALLETAL 


Examiner 

Michail A Belyavskyi 


Art Unit 

1644 





The MAILING DATE of this communication appears on the cover sheet with the correspondence address • 
Period for Reply 

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 MONTH(S) FROM 
THE MAILING DATE OF THIS COMMUNICATION. 

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed 
after SIX (6) MONTHS from the mailing date of this communication. 

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely. 

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. 

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 1 33). 

- Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any 
earned patent term adjustment. See 37 CFR 1.704(b). k * f~r»HP a \ a * « 

KtST AVAILABLE CO' 

1 )M Responsive to communication(s) filed on 30 July 2001 . 
2a)D This action is FINAL. 2b)^ This action is non-final. 

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is 

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 1 1 , 453 O.G. 213. 
Disposition of Claims 

4) ^3 Claim(s) 1-49 is/are pending in the application. 

4a) Of the above claim(s) is/are withdrawn from consideration. 

5) D Claim(s) is/are allowed. 

6) D Claim(s) is/are rejected. 

7) D Claim(s) is/are objected to. 

8) ^3 Claim(s) 1-49 are subject to restriction and/or election requirement. 
Application Papers 

9) D The specification is objected to by the Examiner. 

10) D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner. 

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a). 

1 1) D The proposed drawing correction filed on is: a)Q approved b)D disapproved by the Examiner. 

If approved, corrected drawings are required in reply to this Office action. 

12) D The oath or declaration is objected to by the Examiner. 
Priority under 35 U.S.C. §§ 119 and 120 

13) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f). 

a)D All b)D Some*c)Q None of: 

1 Certified copies of the priority documents have been received. 

2. Q Certified copies of the priority documents have been received in Application No. . 

3. Q Copies of the certified copies of the priority documents have been received in this National Stage 

application from the International Bureau (PCT Rule 17.2(a)). 
* See the attached detailed Office action for a list of the certified copies not received. 

14) ^ Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 1 19(e) (to a provisional application). 

a) □ The translation of the foreign language provisional application has been received. 

15) D Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 and/or 121. 
Attachment(s) 

1 ) □ Notice of References Cited (PTO-892) 4) □ Interview Summary (PTO-41 3) Paper No(s). . 

2) □ Notice of Draftsperson's Patent Drawing Review (PTO-948) 5) □ Notice of Informal Patent Application (PTO-152) 

3) O Information Disclosure Statement(s) (PTO-1449) Paper No{s) . 6) ^ Other: restriction/Election fax . 



U.S. Patent and Trademark Office 
PTO-326 (Rev. 04-01) 



Office Action Summary 



Part of Paper No. 9 



Application/Control Number: 09/919,224 



Art Unit: 1644 



Page 2 



DETAILED ACTION 

Claims 1-49 are pending. 

Restriction Requirement 



1 . Please Note: In an effort to enhance communication with our customers and reduce 
processing time, Group 1640 is running a Fax Response Pilot for Written Restriction 
Requirements. A dedicated Fax machine is in place to receive your responses. The Fax number 
is 703-308-4315. A Fax cover sheet is attached to this Office Action for your convenience. We 
encourage your participation in this Pilot program. If you have any questions or suggestions 
please contact Paula Hutzell, Ph.D., Supervisory Patent Examiner at Paula.Hutzell@uspto.gov or 
703-308-4310. Thank you in advance for allowing us to enhance our customer service. Please 
limit the use of this dedicated Fax number to responses to Written Restrictions. 

2. Restriction to one of the following inventions is required under 35 U.S.C. § 121: 

I. Claims 1, 2 and 4-11, drawn to a method of inhibiting the proliferation of a peripheral 
blood mononuclear cell population, composing contacting the peripheral blood mononuclear cell 
with rhesus CMV IL-10 , classified in Class 435, subclass 363. 

II. Claims 1, and 3-11, drawn to a method of inhibiting the proliferation of a peripheral 
blood mononuclear cell population, composing contacting the peripheral blood mononuclear cell 
with human CMV IL-10 , classified in Class 435, subclass 366. 

III. Claims 12-20, drawn to a method of reducing cytokine production of a monocytes cell 
population, comprising contacting the monocytes cell population with rhesus CMV IL-10 , 
classified in Class 435, subclass 363. 

IV. Claims 12-20, drawn to a method of reducing cytokine production of a monocytes cell 
population, comprising contacting the monocytes cell population with human CMV IL-10 , 
classified in Class 435, subclass 366. 



V. Claims 21-38 , and 44-49 drawn to a method of preventing or treating an immune 
disorder, comprising administering rhesus CMV IL-10, classified in Class 424, subclass 520. 

VI. Claims 21-38 , and 44-49 drawn to a method of preventing or treating an immune 
disorder, comprising administering human CMV IL-10, classified in Class 424, subclass 184.1. 



Application/Control Number: 09/919,224 
Art Unit: 1644 



Page 3 



VII. Claims 39-41, drawn to a method of ameliorating symptoms of hepatitis in an animal 
host, classified in Class 424, subclass 184.1. 

VIII. Claim 42 , drawn to a method of preventing or treating a respiratory viral infection, 
comprising administering rhesus CMV IL-10, classified in Class 424, subclass 520. 

IX. Claim 42 , drawn to a method of preventing or treating a respiratory viral infection 
comprising administering human CMV IL-10, classified in Class 424, subclass 184.1. 

X. Claim 43 , drawn to a method for reducing an in vivo inflammatory response, 
comprising administering rhesus CMV IL-10, classified in Class 424, subclass 520. 

XI. Claim 43 , drawn to a method for reducing an in vivo inflammatory response, 
comprising administering human CMV IL-10, classified in Class 424, subclass 184.1. 



4. Groups I- XI are different methods. These inventions are different with respect to 
ingredients, method steps, and endpoints; therefore, each method is patentably distinct. 

5. These inventions are distinct for the reasons given above. In addition, they have acquired a 
separate status in the art as shown by different classification and/or recognized divergent subject 
matter. Further, even though in some cases the classification is shared, a different field of search 
would be required based upon the structurally distinct products recited and the various methods 
of use comprising distinct method steps. Moreover, a prior art search also requires a literature 
search. It is an undue burden for the examiner to search more than one invention. Therefore 
restriction for examination purposes as indicated is proper. 



Species Election 



6. Applicant is further required under 35 USC 121 (1) to elect a single disclosed species to 
which the claims would be restricted if no generic claim is finally held to be allowable and (2) to 
list all claims readable thereon including those subsequently added. 

7. If Groups I or II are elected, applicant is required to elect a specific method of inhibiting the 
proliferation of a peripheral blood mononuclear cell population comprising monitoring secretion 
of: 

A) IFN-y or 

B) TNF-ot. 



Application/Control Number: 09/919,224 
Art Unit: 1644 



Page 4 



These species are distinct because the methods of monitoring secretion of IFN-y or 

TNF-ot differ with respect to the specific test agent and the endpoint of the method; thus each 

specific method employing a specific test agent represents patentably distinct subject matter. 

8. If Groups III or IV are elected, applicant is required to elect a specific method of reducing 
cytokine production of a monocytes cell, comprising monitoring secretion of specific cytokine, 
selected from the group recited in claim 20. 

These species are distinct because the methods of monitoring secretion of specific cytokine, 
selected from the group recited in claim 20 differ with respect to the specific test agent and the 
endpoint of the method; thus each specific method employing a specific test agent represents 
patentably distinct subject matter. 

9. If Groups V or VI are elected, applicant is required to elect a specific method of preventing or 
treating specific immune disorder, wherein an immune disorder selected from the group recited 
in claim 24. 

These species are distinct because method of preventing or treating specific immune disorder, 
differ in etiologies and therapeutic endpoints of pathological conditions; thus each condition 
represents patentably distinct subject matter. 

In addition, applicant is required to elect a specific method of preventing or treating specific 
chronic inflammatory disease, wherein specific chronic inflammatory disease selected from the 
group recited in claims 33 and 49. 

These species are distinct because method of preventing or treating specific chronic 
inflammatory disease differ in etiologies and therapeutic endpoints of pathological conditions; 
thus each condition represents patentably distinct subject matter. 

In addition, applicant is required to elect a specific method of preventing or treating specific 
immune disorder in patient wherein patient is suffering from a type T H 1 immune response to a 
specific transplant graft organ selected from the group recited in claim 37. 

These species are distinct because specific method of preventing or treating specific immune 
disorder in patient wherein patient is suffering from a type T H 1 immune response to a specific 
transplant graft organ selected from the group recited in claim 37 differ in etiologies and 
therapeutic endpoints of pathological conditions; thus each condition represents patentably 
distinct subject matter. 

10. If Group VII is elected, applicant is required to elect a specific method of ameliorating 
symptoms of hepatitis in an animal host, wherein the administering step ameliorates : 

A) liver disease or, 



Application/Control Number: 09/919,224 
Art Unit: 1644 



Page5 



B) liver fibrosis. 

These species are distinct because a specific method of ameliorating symptoms of hepatitis in an 
animal host, wherein the administering step ameliorates liver disease or liver fibrosis differ in 
etiologies and therapeutic endpoints of pathological conditions; thus each condition represents 
patentably distinct subject matter. 

1 1 . If Groups X or XI are elected, applicant is required to elect a specific method for reducing 
an in vivo inflammatory response characterized by substantially elevated levels of at least one 
specific cytokine selected from the group recited in the claim 43. 

These species are distinct because the methods for reducing an in vivo inflammatory response 
characterized by substantially elevated levels of at least one specific cytokine selected from the 
group recited in the claim 43 differ with respect to the specific test agent and the endpoint of the 
method; thus each specific method employing a specific test agent represents patentably distinct 
subject matter. 



Applicant is advised that a response to this requirement must include an identification of the 
species that is elected consonant with this requirement, and a listing of all claims readable 
thereon, including any claims subsequently added. An argument that a claim is allowable or that 
all claims are generic is considered non-responsive unless accompanied by an election. 

Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to 
additional species which are written in dependent form or otherwise include all the limitations of 
an allowed generic claim as provided by 37 C.F.R. § 1.141. If claims are added after the 
election, applicant must indicate which are readable upon the elected species. M.P.E.P. § 
809.02(a). 

Should applicant traverse on the ground that the species are not patentably distinct, applicant 
should submit evidence or identify such evidence now of record showing the species to be 
obvious variants or clearly admit on the record that this is the case. In either instance, if the 
examiner finds one of the inventions unpatentable over the prior art, the evidence or admission 
may be used in a rejection under 35 U.S. C. § 103 of the other invention. 

12. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the 
inventorship must be amended in compliance with 37 C.F.R. § 1.48(b) if one or more of the 
currently named inventors is no longer an inventor of at least one claim remaining in the 
application. Any amendment of inventorship must be accompanied by a diligently- filed petition 
under 37 C.F.R. § 1.48(b) and by the fee required under 37 C.F.R. § 1.17(h). 



Application/Control Number: 09/919,224 



Page 6 



Art Unit: 1644 



13. Any inquiry concerning this communication or earlier communications from the examiner 
should be directed to Michail Belyavskyi whose telephone number is (703) 308-4232. The 
examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A 
message may be left on the examiner's voice mail service. If attempts to reach the examiner by 
telephone are unsuccessful, the examiner's supervisor, Christina Chan can be reached on (703) 
308-3973. Any inquiry of a general nature or relating to the status of this application should be 
directed to the Technology Center 1600 receptionist whose telephone number is (703) 308-0196 



Papers related to this application may be submitted to Technology Center 1600 by facsimile 
transmission. Papers should be faxed to Technology Center 1600 via the PTO Fax Center 
located in Crystal Mall 1. The faxing of such papers must conform with the notice published in 
the Official Gazette, 1096 OG 30 (November 15, 1989). The CM1 Fax Center telephone number 
is (703) 305-3014. 

Michail Belyavskyi, Ph.D. 
Patent Examiner 

Technology Center 1600 j _ a . 



October 1,2002 



CHRISTINA CHAN 
SUPERVISORY PATENT EXAMINER 
TECHNOLOGY CENTER 1600