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- 28 - SEBBEL et al 

Appl. No. 09/848,616 

Remarks 

L Status of the Claims 

By the forgoing amendments, claims 28-31, 34-38, 41-44, 48-56, 61-62, 78-80 and 
83-85 have been cancelled without prejudice thereto or disclaimer thereof. Applicants 
reserve the right to prosecute the subject matter of these claims in one or more continuing 
applications. Also by the foregoing amendments, new claims 86-1 10 are sought to be added. 
Support for these new claims can be found throughout the specification, particularly in 
claims 28-85 as originally filed; and in the specification throughout the Examples and in the 
description, for example at page 34, paragraph 137, at page 43, paragraph 166, and at page 
58, paragraph 226. 

Hence, these amendments do not add new matter, and their entry and consideration 
are respectfijUy requested. Upon entry of the foregoing amendments, claims 1-27, 32, 33, 
39, 40, 45-47, 57-60, 63-77, 81, 82 and 86-1 10 are pending in the appUcation, with claims 
1, 1 1, 21, 63 and 86-89 being the independent claims. 

//• Summary of the Office Action 

In the Office Action dated February 7, 2003, the Examiner has made two objections 
to, and eight rejections of, the claims. Based on the following remarks. Applicants 
respectfiilly request that the Examiner reconsider all outstanding objections and rejections 
and that they be withdrawn. 



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SEBBEL et aL 
AppL No. 09/848,616 



///. The Objection to Claims Directed to Non-elected Species is Accommodated 

In the Office Action at page 2, the Examiner has objected to claims 28-30, 34, 36-38, 
41-44, 48-56, 61, 62, 78-80, and 83-85 as reading, at least in part, on non-elected species. 
Applicants respectfully traverse this objection. However, to expedite prosecution and not 
in acquiescence to this objection, claims 28-30, 34, 36-38, 41-44, 48-56, 61, 62, 78-80, and 
83-85 have been cancelled, thus rendering this objection moot. Applicants further note that 
new claims 86-1 10 are not drawn to non-elected species; hence, this objection should not 
be asserted against the new claims entered above. 

IV. The Objection to Claims of Improper Form is Accommodated 

In the Office Action at page 2, the Examiner has objected to claims 48-56, 79, 80 
and 83-85 as being in improper form, for presenting multiple dependent claims that 
depend fi-om other multiple dependent claims. By the forgoing amendments, and for reasons 
unrelated to this objection, claims 48-56, 79, 80 and 83-85 have been cancelled, thus 
rendering this objection moot. Applicants note that new claims 86-110 do not contain 
improper multiple dependencies; hence, this objection should not be asserted against the new 
claims entered above. 

V. The Rejection under 35 U.S.C. § 112, Second Paragraph 

In the Office Action at page 3, the Examiner has rejected claims 34-38, 41-44, 61, 
62 and 78 under 35 under 35 U.S.C. § 1 12, second paragraph, for failing to particularly point 



- 30 - SEBBEL et al 

AppL No. 09/848,616 

out and distinctly claim the subject matter which Applicants regard as the invention. By the 
foregoing amendments, claims 34-38, 41-44, 61, 62 and 78 have been cancelled, rendering 
this rejection moot. 

Applicants also respectfully assert that new claims 86-89, and the remaining claims 
that depend therefrom, should not be rejected on these same grounds, since the recitation of 
"a core particle" in section (a)(i) of claims 86-89 provides the antecedent basis for the 
recitation of "said core particle" in section (a)(ii) of these same claims. Hence, this rejection 
has been overcome, and Applicants therefore respectfully request that the rejection under 
35 U.S.C. § 1 12, second paragraph, be reconsidered and withdravra. 

VI. The Rejection Under 35 U.S. C. § 102(e) Over Birkett 

In the Office Action at page 3, the Examiner has rejected claims 28-31, 61 and 62 
under 35 U.S.C. § 102(e), as being unpatentable over Birkett et al (document "A" cited on 
the Form PTO-982 attached to Paper No. 11; hereinafter "Birkett"). By the foregoing 
amendments, claims 28-31, 61 and 62 have been cancelled, rendering this rejection moot. 

Applicants also respectfully assert that new claims 86-89, and the remaining claims 
that depend therefrom, should not be rejected on these same grounds. Claims 86-89 recite, 
in relevant part, the use of core particles having particular amino acid characteristics (/.e., 
having polypeptides that are based upon SEQ ID NO: 134 or SEQ ID NO: 158, but in which 
the cysteine residues at positions 48 and 107 in SEQ ID NO: 134, or at positions 48 and 110 
in SEQ ID NO: 158 (which correspond to positions 48 and 107 in SEQ ED NO: 134), are 
deleted or substituted with another amino acid. Applicants respectfully assert that Birkett 
does not disclose each and every element of the claims as currently presented. Specifically, 



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Appl. No. 09/848,616 

Birkett does not disclose the use of core particles in which the cysteine residues at positions 
48 and 107 of SEQ ED NO: 134 (or at positions 48 and 1 10 of SEQ ED NO: 158) are either 
deleted or substituted with another amino acid. Instead, the sequence in Birkett that is 
referred to by the Examiner in making this rejection contains a cysteine at postion 48, and 
does not contain the Gly-Gly-Lys-Gly-Gly substitution for amino acids 79 and 80 of SEQ 
ID NO:134 to resuh in SEQ ID NO:158. 

Under 35 U.S.C. § 102, a claim can only be anticipated if every element in the claim 
is expressly or inherently disclosed in a single prior art reference. See Kalman v. Kimberly 
Clark Corp., 713 F.2d 760, 711 (Fed.Cir. 1983), cert, denied, 465 U.S. 1026 (1984). As 
noted above, Birkett clearly does not disclose a virus-like particle that is a dimer or a 
multimer of a polypeptide having the amino acid sequence characteristics recited in present 
claims 86-89. Therefore, Birkett does not disclose every element of the presently claimed 
invention, and in view of Kalman, Birkett cannot and does not anticipate the presently 
claimed invention. 

VIL The Rejection Under 35 U.S. C. § 103(a) Over Birkett 

In the Office Action at pages 4-5, the Examiner has rejected claims 41, 42, 44, 48- 
56, 79 and 80 under 35 U.S.C. § 103(a) as being unpatentable over Birkett. By the foregoing 
amendments, claims 41, 42, 44, 48-56, 79 and 80 have been cancelled, rendering this 
rejection moot. 

Applicants also respectfully assert that new claims 86-89, and the remaining claims 
that depend therefrom, should not be rejected on these same grounds. As discussed above, 
claims 86-89 recite, in relevant part, the use of core particles having particular amino acid 



- 32 - SEBBEL et al 

Appl.No. 09/848,616 

characteristics (/.e., having polypeptides that are based upon SEQ ID NO: 134 or SEQ ID 
NO: 158, but in which the cysteine residues at positions 48 and 107 in SEQ ED NO: 134, or 
at positions 48 and 1 10 in SEQ ID NO: 158 (which correspond to positions 48 and 107 in 
SEQ ED NO: 134), are deleted or substituted with another amino acid. For reasons noted 
above, which are reiterated and incorporated herein by reference, Birkett is seriously 
deficient as a reference upon which to base a prima facie case of obviousness. Specifically, 
Birkett does not disclose, suggest, or otherwise contemplate the use of a virus-like particle 
that is a dimer or a multimer of a polypeptide having the amino acid sequence characteristics 
recited in present claims 86-89. 

In proceedings before the Patent and Trademark Office, the Examiner bears the 
burden of establishing a prima facie case of obviousness based upon the prior art. See In re 
Piasecki, 223 USPQ 785, 787-88 (Fed. Cir. 1984). The Examiner can satisfy this burden 
only by showing some objective teaching in the prior art, or that knowledge generally 
available to one of ordinary skill in the art, would lead that individual to combine the 
relevant teachings of the references in such a way as to produce the invention as claimed, 
see In re Fine, 5 USPQ2d 1596,1598 (Fed. Cir. 1988). In the present case, the Examiner's 
burden has not been satisfied since such a reason, suggestion, or motivation is completely 
lacking in the disclosure of Birkett. Specifically, the Examiner has pointed to no disclosure 
or suggestion in Birkett that would have motivated one of ordinary skill to have modified 
the sequence disclosed in Birkett so as to make and use the presently claimed core particles. 
Absent such suggestion and motivation, the claimed invention cannot be held to be obvious 
over Birkett. 



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Appl. No. 09/848,616 

VIIL The Rejection Under 35 U.S.C. § 103(a) Over Birkett in View ofPasek 

In the Office Action at pages 4-5, the Examiner has rejected claims 34, 35, 37, 41, 
42, 44, 48-56, 61, 62, 79 and 80 under 35 U.S.C. § 103(a) as being unpatentable over Birkett 
in view of Pasek et al (document "V" cited on the Form PTO-892 attached to Paper No. 1 1 ; 
hereinafter "Pasek"). By the foregoing amendments, claims 34, 35, 37, 41, 42, 44, 48-56, 61, 
62, 79 and 80 have been cancelled, rendering this rejection moot. 

Applicants also respectfully assert that new claims 86-89, and the remaining claims 
that depend therefrom, should not be rejected on these same grounds. For reasons noted 
above, which are reiterated and incorporated herein by reference, Birkett is seriously 
deficient as a reference upon which to base a prima facie case of obviousness. Specifically, 
Birkett does not disclose, suggest, or otherwise contemplate the use of a virus-like particle 
that is a dimer or a multimer of a polypeptide having the amino acid sequence characteristics 
recited in present claims 86-89. Indeed, the Examiner correctly notes that the core sequence 
in Birkett differs from SEQ ID NO: 158 of the present invention. However, the Examiner 
contends that the skilled artisan would have been motivated to substitute the Hepatitis B 
sequence disclosed in Pasek for the sequence utilized in Birkett to generate the claimed 
invention. Applicants respectfiilly disagree with this contention. The Examiner fiirther 
asserts that Pasek discloses a Hepatitis B core sequence "which is identical to SEQ 95 [sic\ 
SEQ DD NO: 158] except for a 5-amino acid insert at residue 78 . . . Office Action at page 
5, line 14. Applicants note that, as the Examiner has stated, the amino acid sequence 
disclosed in Pasek is not identical to SEQ ID NO: 158 disclosed in the present application. 
Applicants therefore submit that Pasek does not cure the deficiencies in Birkett, as neither 
the sequence disclosed in Birkett nor the sequence disclosed in Pasek are identical to SEQ 



- 34 - SEBBEL et al. 

Appl. No. 09/848,616 

IDNO:158. 

Moreover, as noted above, claims 86-89 recite, in relevant part, the use of core 
particles having particular amino acid characteristics (i.e., having polypeptides that are based 
upon SEQ ID NO: 134 or SEQ ID NO: 158, but in which the cysteine residues at positions 
48 and 107 in SEQ ID NO:134, or at positions 48 and 110 in SEQ ID NO:158 (which 
correspond to positions 48 and 107 in SEQ ID NO: 134), are deleted or substituted with 
another amino acid. As discussed above, Birkett does not disclose or suggest such core 
particles, and these deficiencies are not cured by the disclosure of Pasek which does not 
suggest core particles in which the cysteine residues at postions 48 and 107 of SEQ ID 
NO: 134 (or at positions 48 and 110 of SEQ ID NO: 158) are either deleted or substituted 
with another amino acid. Hence, one of ordinary skill would have found no disclosure or 
suggestion that would have motivated one of ordinary skill to have modified the HBV 
sequence of Birkett with the sequence of Pasek, in order to make and use the core sequences 
recited in the present claims. Absent such suggestion and motivation, the cited references 
may not be properly combined to render the claimed invention obvious. See In re Fine, 
5 USPQ2d 1596,1598 (Fed. Cir. 1988). Thus, the burden required to sustain a prima facie 
case of obviousness cannot be met using the disclosures of Birkett and Pasek. 

The Examiner is also reminded that it is axiomatic that, in order to support a prima 
facie case of obviousness, the prior art must suggest making the specific molecular 
modifications necessary to achieve the claimed invention. See In re Deuel, 51 F.3d 1552, 
1558 (Fed. Cir. 1995); In reLalu, lAl F.2d 703, 705 (Fed. Cir. 1984) ("[t]he prior art must 
provide one of ordinary skill in the art the motivation to make the proposed molecular 
modifications needed to arrive at the claimed compound.")- That is, simply because "one 



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AppL No. 09/848,616 

can conceive a general process in advance for preparing an undefined compound [e.g., a core 
particle comprising a 'Hepatitis B amino acid sequence'] does not mean that a claimed 
specific compound [e.g., a core particle comprising SEQ ID NO: 134 or SEQ ID NO: 158 (or 
portions thereof) which is modified so that the cysteine residues at positions 48 and 107 of 
SEQ ID NO: 134 (or 48 and 1 10 of SEQ ID NO: 158) are either deleted or substituted with 
another amino acid'] was precisely envisioned and therefore obvious." Deuel at 1559. 
Thus, in order for either Birkett and/or Pasek to be suitable as references upon which to base 
a prima facie case of obviousness, there must be, at a minimum, a teaching or suggestion in 
these references that would have compelled one of ordinary skill in the art to include in their 
core particles a polypeptide having the amino acid characteristics recited in claims 86-89, 
which are substantially different from those of the HBV sequences disclosed in these 
references. As noted above, such a teaching or suggestion is wholly lacking in both Birkett 
and Pasek. Therefore, these dociunents are seriously deficient as a primary references 
(particularly in view of the holdings in Deuel and Lalii), and cannot support a prima facie 
case of obviousness of the presently claimed invention. 

IX. The Rejection Under 35 U.S.C. § 103(a) Over Birkett in View ofNeurath 

In the Office Action at page 6, the Examiner has rejected claims 43 and 78 under 
35 U.S.C. § 103(a) as being unpatentable over Birkett in view ofNeurath et al (document 
"B" cited on the Form PTO-892 attached to Paper No.l 1; hereinafter "Neurath"). By the 
foregoing amendments, claims 43 and 78 have been cancelled, rendering this rejection moot. 

Applicants also respectfully assert that new claims 86-89, and the remaining claims 
that depend therefi-om, should not be rejected on these same grounds. For reasons noted 



- 36 - SEBBEL et al. 

Appl. No. 09/848,616 

above, which are reiterated and incorporated herein by reference, Birkett is seriously 
deficient as a reference upon which to base a prima facie case of obviousness. Specifically, 
Birkett does not disclose, suggest, or otherwise contemplate the use of a virus-like particle 
that is a dimer or a multimer of a polypeptide having the amino acid sequence characteristics 
recited in present claims 86-89. These deficiencies in Birkett are not cured by the disclosure 
of Neurath, which provides no suggestion or disclosure of the use of core particles having 
the amino acid sequence characteristics recited in present claims 86-89. Hence, under 
Piasecki and Fine^ Birkett and Neurath cannot be properly combined in the attempt to render 
obvious the present claims. 

X, The Rejection Under 35 U,S.C. § 103(a) Over Birkett in View of Pasek, Mark and 
Zhou 

In the Office Action at pages 6 and 7, the Examiner has rejected claims 36 and 38 
under 35 U.S.C. § 103(a) as being unpatentable over Birkett in view of Pasek, and fiirther 
in view of Mark et al (document "C" cited on the Form PTO-892 attached to Paper No. 1 1 ; 
hereinafter "Mark") and Zhou et al. (document "Z" cited on the Form PTO-892 attached to 
Paper No. 11; hereinafter "Zhou"). By the foregoing amendments, claims 43 and 78 have 
been cancelled, rendering this rejection moot. 

Applicants also respectfially assert that new claims 86-89, and the remaining claims 
that depend therefi-om, should not be rejected on these same grounds. For reasons discussed 
above (which are reiterated and incorporated by reference herein by reference), Birkett, alone 
or in combination with Pasek, does not disclose, suggest or otherwise contemplate the 
presently claimed invention, since these references do not disclose, suggest or otherwise 



- 37 - SEBBEL et al 

Appl. No, 09/848,616 

contemplate a core particle having the amino acid sequence characteristics recited in the 
claims as currently presented. Hence, Birkett and Pasek are seriously deficient as references 
upon which to attempt to base a prima facie case of obviousness. 

These deficiencies in Birkett and Pasek are not cured by the disclosures of Mark or 
Zhou, alone or in combination, neither of which provides any suggestion or disclosure of the 
use of core particles having the amino acid sequence characteristics recited in present claims 
86-89. Hence, under Piasecki and Fine^ Birkett, Pasek, Mark and Zhou cannot be properly 
combined in the attempt to render obvious the present claims. 

XIL The Rejection Under 35 U.S.C. § 103(a) Over Birkett in View of Davis 

In the Office Action at page 7, the Examiner has rejected claims 83-85 under 
35 U.S.C. § 103(a) as being unpatentable over Birkett in view of Davis et al (document 'TSf" 
cited on the Form PTO-892 attached to Paper No. 1 1 ; hereinafter "Davis"). By the foregoing 
amendments, claims 83-85 have been cancelled, rendering this rejection moot. 
Applicants also respectfully assert that new claims 86-89, and the remaining claims that 
depend therefrom, should not be rejected on these same grounds. For reasons discussed 
above (which are reiterated and incorporated by reference herein by reference), Birkett does 
not disclose, suggest or otherwise contemplate the presently claimed invention, since these 
references do not disclose, suggest or otherwise contemplate a core particle having the 
amino acid sequence characteristics recited in the claims as currently presented. Hence, 
Birkett is seriously deficient as a reference upon which to attempt to base a prima facie case 
of obviousness. These deficiencies in Birkett are not cured by the disclosure of Davis, which 
provides no suggestion or disclosure of the use of core particles having the amino acid 



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AppL No, 09/848,616 

sequence characteristics recited in present claims 86-89. Hence, under Piasecki and Fine, 
Birkett and Davis cannot be properly combined in the attempt to render obvious the 
present claims. 

XIIL The Double Patenting Rejection 

In the Office Action at pages 7-8, the Examiner has provisionally rejected claims 28- 
31, 34-38, 41-44, 48-56, 61, 62, 78-80 and 83-85 under the judicially created doctrine of 
obviousness-type double-patenting, as allegedly being'patentably indistinct from claims 50, 
51, 54, 57 and 58 in copending Application No. 09/449,631. By the foregoing amendments, 
claims 28-31, 34-38, 41-44, 48-56, 61, 62, 78-80 and 83-85 have been cancelled, thus 
rendering this rejection moot, 

IX. Con elusion 

All of the stated grounds of objection and rejection have been properly traversed. 
Applicants therefore respectfully request that the Examiner reconsider all presently 
outstanding objections and rejections and that they be withdrawn. 

Applicants believe that a full and complete reply has been made to the outstanding 
Office Action and, as such, the present application is in condition for allowance. If the 
Examiner believes, for any reason, that personal communication will expedite prosecution 
of this application, the Examiner is invited to telephone the undersigned at the number 
provided. 



- 39 - SEBBEL et aL 

Appl. No. 09/848,616 

Prompt entry and consideration of the present Amendment and Reply, and allowance 
of all pending claims, are earnestly solicited. 



Respectfully submitted, 

Sterne, Kessler, Goldstein & Fox p.l.l.c. 

Brian J. Del Buono 
Attorney for Applicants 
Registration No. 42,473 

Date: 

1 1 00 New York Avenue, N. W. 
Washington, D.C. 20005-3934 
(202) 371-2600 

156226 3. DOC