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United States Patent and Trademark Office 



UNITED STATES DEPARTMENT OF COMMERCE 
United States Patent and Trademark Office 
Address: COMMISSIONER FOR PATENTS 
P.O. Box 1450 

Alexandria, Virginia 22313-1450 
www.uspto.gov 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



ATTORNEY DOCKET NO. 



CONFIRMATION NO. 



09/848,616 



28393 



05/04/2001 



Peter Sebbel 



7590 



10/31/2003 



STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C. 
1 100 NEW YORK AVE., N.W. 
WASHINGTON, DC 20005 



1700.01 80002/JAG/BJD 



6018 



EXAMINER 



MOSHER, MARY 



ART UNIT 



PAPER NUMBER 



1648 

DATE MAILED: 10/31/2003 



Y 



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



PTO-90C (Rev. 10/03) 



Offic Action Summary 



Application N . 

09/848,616 


Applicant(s) 

SEBBEL ET AL 


Examiner 

Mary E. Mosher, Ph.D. 


Art Unit 

1648 





~ 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 3 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. § 133). 

- 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). 

Status 

1)D Responsive to communication(s) filed on 5/9/2002. 8/7/2003 . 
2a)S This action is FINAL. 2b)D 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, 1 935 CD. 1 1 , 453 O.G. 21 3. 
Disp sition of Claims 

4) D Claim(s) 1-27.32.33.39.40.45-47.57-60.63-77.81.82 and 86-110 is/are pending in the application. 

4a) Of the above claim(s) 1-27. 32.33.39 \4Q 145-47. 57-60.63-77. 81 and 82 is/are withdrawn from consideration. 

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

6) D Claim(s) 86-110 is/are rejected. 

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

8) D Claim(s) 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). 

11) D The proposed drawing correction filed on is: a)D 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 

1 3) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 1 9(a)-(d) or (f). 

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

1 .□ Certified copies of the priority documents have been received. 

2.D 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. § 119(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) 

2) O Notice of Draftsperson's Patent Drawing Review (PTO-948) 

3) ^ Information Disclosure Statement(s) (PTO-1449) Paper No(s) 6 . 



4) □ Interview Summary (PTO-41 3) Paper No(s). 

5) □ Notice of Informal Patent Application (PTO-1 52) 

6) D Other: 



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



Office Action Summary 



Part of Paper No. 1 4 



Application/Control Number: 09/848,616 
Art Unit: 1648 



Page 2 



DETAILED ACTION 
Election/Restrictions 

Newly filed claims 87-89 are withdrawn from further consideration pursuant to 37 CFR 
1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking 
claim. Election was made without traverse in Paper No. 9. Claims 90-1 10 have been examined 
only to the extent that they read upon the elected species, 90% identity to SEQ ID NO: 158. 
Note, SEQ ID NO: 134 differs from SEQ ID NO: 158 by more than just a substitution at amino 
acids 79 and 80; a quick visual inspection indicates additional differences at e.g. positions 35 and 
40. In any case, 90% identical to SEQ ID NO: 134 or 90% identical to residues 1-149 of SEQ 
134 is not the same as 90% identical to SEQ 158, even if there is some overlapping subject 
matter. 

Claim Rejections - 35 USC §103 

Claims 86, 90-94, 96-107 are rejected under 35 U.S.C. 103(a) as being unpatentable over 
Birkett 6,231,864 in view of Mark et al 4,959,314 and Zhou et al (Journal of Virology 66(9): 
5393-5398, 1992), for reasons similar to the previous rejection applied to claims 36 and 38. 

As discussed in the previous Office action, Birkett teaches hepatitis B core particles 
modified to contain a chemically reactive amino acid (such as lysine inserted at residue 78), and 
chemical conjugation of an antigenic determinant to the reactive amino acid by a linker. Birkett' s 
core sequence is more than 90% identical to SEQ ID NO: 158. Birkett differs from the claimed 
invention only in that Birkett does not teach modification of the cysteine residues corresponding 
to positions 48 and 1 10 in SEQ ID NO: 158. However, as discussed previously, Mark teaches 
deletion or replacement of nonessential cysteines to reduce or eliminate undesirable 
intramolecular or intermolecular cross linking, and Zhou teaches that all of the HBV core 
cysteines are nonessential for assembly of core particles. Therefore, it would have been obvious 
to delete or replace some or all of the HBV core cysteines, including these two, to achieve the 



Application/Control Number: 09/848,616 
Art Unit: 1648 



Page 3 



advantages taught by Mark, with reasonable expectation of success. The invention as a whole is 
therefore prima facie obvious, absent unexpected results. 

Claim 95 is rejected under 35 U.S.C. 103(a) as being unpatentable over Birkett in view of 
Mark et al and Zhou et al as applied to claims 86, 90-94, 96-107 above, and further in view of 
Neurath et al 5,565,548. As discussed in the previous rejection of claims 43 and 78, this claim 
further limits the invention by requiring that the attached immunogenic determinant induce an 
immune response against an allergen. Birkett teaches that any hapten against which antibody 
production is desired can be attached to the modified HBV core particle, see column 13, lines 37- 
40. Birkett does not specifically discuss antibody production against allergens. However, 
Neurath teaches combination of HBV and allergen immunogens see for example the Abstract 
and claims 1-2. Therefore, an immunogenic determinant of an allergen would have been an 
obvious species to choose within the broad teachings of Birkett. The invention as a whole is 
therefore prima facie obvious, absent unexpected results. 

Claims 108-1 10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Birkett in 
view of Mark et al and Zhou et al as applied to claims 86, 90-94, 96-107 above, and further in 
view of Davis et al WO 98/40100. As discussed in the previous rejection of claims 83-85, these 
claims further limit the invention in that they specify inducing a Th2 response, without 
generating a Thl response. As discussed above, Birkett suggests combination of modified HBV 
core particles with adjuvants. One of the suggested adjuvants is alum, see column 24, line 1; 
alum is well known to be commonly used in human vaccines. Davis et al teaches that the 
combination of alum with hepatitis B particles leads to a Th2 response, without Thl response, 
see page 25. Therefore, for one of ordinary skill in the art wishing to induce a TH2 response, it 
would have been obvious to choose the alum-adjuvanted embodiment suggested by Birkett, with 
reasonable expectation of success. 



Application/Control Number: 09/848,616 
Art Unit: 1648 



Page 4 



Response to Arguments 
Applicant argues that Birkett does not teach the cysteine modifications, and asserts that 
Mark and Zhou do not cure the deficiency because they do not teach or suggest core particles 
having the amino acid sequence characteristics recited in the claims. In response to applicant's 
arguments against the references individually, one cannot show nonobviousness by attacking 
references individually where the rejections are based on combinations of references. See In re 
Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 
USPQ 375 (Fed. Cir. 1986). Mark provides reasons to modify nonessential cysteines, Zhou 
teaches that any and all of the cysteines are nonessential in the HB V particle, and the combined 
teachings of the references suggest modification of the cysteines (including the recited cysteines) 
in the particle of Birkett. Applicant has not pointed to any unexpected result, therefore it is 
maintained that the invention as claimed is prima facie obvious. 

Double Patenting 

Claims 86, 90-1 10 are provisionally rejected under the judicially created doctrine of 
obviousness-type double patenting as being unpatentable over claiml00-114 of copending 
Application No. 10/050,902. Although the conflicting claims are not identical, they are not 
patentably distinct from each other because both sets of claims include the array based upon the 
cysteine-modified derivative of SEQ ID NO: 158. 

This is a provisional obviousness-type double patenting rejection because the conflicting 
claims have not in fact been patented. 

Claims 86, 90-1 10 are provisionally rejected under the judicially created doctrine of 
obviousness-type double patenting as being unpatentable over claims 14-16 of copending 
Application No. 10/050,898. Although the conflicting claims are not identical, they are not 
patentably distinct from each other because both sets of claims include the array based upon the 
cysteine-modified derivative of SEQ ID NO: 158. 



Application/Control Number: 09/848,616 



Page 5 



Art Unit: 1648 

This is a provisional obviousness-type double patenting rejection because the conflicting 
claims have not in fact been patented. 



Applicant's amendment necessitated the new ground(s) of rejection presented in this 
Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). 

A shortened statutory period for reply to this final action is set to expire THREE 
MONTHS from the mailing date of this action. In the event a first reply is filed within TWO 
MONTHS of the mailing date of this final action and the advisory action is not mailed until after 
the end of the THREE-MONTH shortened statutory period, then the shortened statutory period 
will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 
1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, 
will the statutory period for reply expire later than SIX MONTHS from the date of this final 
action. 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Mary E. Mosher, Ph.D. whose telephone number is 703-308- 
2926. The examiner can normally be reached on M-T and alternate F. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, James Housel can be reached on 703-308-4027. The fax phone number for the 
organization where this application or proceeding is assigned is (703) 872-9306. 

Any inquiry of a general nature or relating to the status of this application or proceeding 
should be directed to the receptionist whose telephone number is 703-308-0196. 



Conclusion 



10/30/03 




GROUP fi*o§