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F I N N EG AN 
HENDERSON 
FARABOW 
GARRETT & 
DUNNERLkf 

1300 I Street, NW 
Washington, DC 20005 
202.408.4000 
Fax 202.408.4400 
www.fi nnegan .com 



PATENT 
Customer No. 22,852 
Attorney Docket No. 08702.0039-02000 

REMARKS 

In the specification, the paragraphs beginning at page 1 , line 1 and page 23, line 
19 has been amended to correct the priority claims and to insert information about the 
deposit of nucleotide sequences. 

Claims 24-26, 29, 30, 33, 35, 36, 38, 39, 41 , and 42, to the extent that they are 
drawn to a polynucleotide encoding amino acids 299-396 of Figure 2, remain pending in 
the application. Claims 1-23, 27, 28, 31 , 32, 37, 40, and 43-49 have been cancelled. 
Claims 24-26, 29, 30, 33, 35, 36, and 41 have been amended. In light of the 
Examiner's restriction requirement, Applicants reserve the right to pursue the subject 
matter of ail cancelled claims in one or more divisional applications. 

OBJECTION TO THE SPECIFICATION 

The Examiner has objected to the paragraphs containing continuing data. 
Applicants request that the paragraph(s) added by preliminary amendment be deleted 



or disregarded and that the first paragraph of the specification as filed be amended as 
set forth above to provide the correct history of the application. 

CLAIM OBJECTIONS 

The Examiner has objected to claim 33, and claims 36, 39, and 42, which 
depend from claim 33, under 37 C.F.R. § 1 .75(c) as being of improper dependent form. 
Applicants have amended claim 33 so that it no longer refers to any prior claim. 
Therefore, claim 33, and the claims depending from it, are not in improper dependent 
form. Applicants request that the Examiner withdraw this objection. 



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FINNEGAN 
HENDERSON 
FARABOW 
GARRETT & 
DUNNERllp 

1 300 I Street, NW 
Washington, DC 20005 
202.408.4000 
Fax 202.408.4400 
www.finnegan.com 



PATENT 
Customer No. 22,852 
Attorney Docket No. 08702.0039-02000 

REJECTIONS UNDER 35 U.S.C. S 112 

The Examiner rejected claim 41 under 35 U.S.C. § 1 12, first paragraph, as 
allegedly failing to comply with the enablement requirement. The Examiner requests 
that Applicant provide evidence of public availability of the claimed nucleic acid 
molecule ATCC deposits 40345 and 40342. Applicants submit a Declaration and a 
copy of the deposit papers stating that these nucleic acid molecules have been 
deposited under the Budapest Treaty and that ATCC deposits 40345 and 40342 will be 
released to the public upon issuance of a patent. In light of this Declaration, Applicants 
request that this rejection be withdrawn. 

The Examiner also requests that Applicant amend the specification to include the 
appropriate information about the nucleotide deposits. As indicated above, this 
information has been inserted into the specification in the paragraph beginning at page 
23, line 19. 

TheExaminerrejected claims-33r-36-39 r and 42~under-35-UvS,C.~§-1-12,-first 



paragraph, as allegedly failing to comply with the written description requirement and 
under 35 U.S.C. § 1 12, second paragraph, for alleged indefiniteness. The Examiner 
contends that the claims do not require that the encoded polypeptide possess any 
particular biological activity. Applicants have amended claim 33 to recite that the DNA 
sequence encodes a protein capable of inducing bone and/or cartilage formation. This 
amendment supplies the appropriate identifying characteristics of the claimed genus. 

The Examiner also contends that the compositions of claims 33, as well as 
dependent claims 36, 39, and 42, are not adequately described in the specification. 
Specifically, the Examiner states that "only isolated polynucleotides encoding 



FINNEGAN 
HENDERSON 
FARABOW 
GARRETT & 
DUNNERllp 

1300 I Street, NW 
Washington, DC 20005 
202.408.4000 
Fax 202.408.4400 
www.finnegan.com 



PATENT 
Customer No. 22,852 
Attorney Docket No. 08702.0039-02000 

polypeptides comprising the amino acid sequence set for the in SEQ ID NO:4, but not 

the full breath of the claim meets the written description requirement." Applicants 

disagree. 

Page 8, lines 3-9 of the specification describes, as encompassed by the 
invention, sequences that hybridize to the sequence of Figure 2 under stringent 
conditions - as defined by T. Maniatis et al., Molecular Cloning (A Laboratory Manual) , 
Cold Spring Harbor Laboratory (1982). At page 22, line 23-page 24, line 28, the 
specification provides a detailed description of the identification and isolation of DNA 
sequences that hybridize to the sequence of Figure 2 under stringent hybridization 
conditions. Specific conditions are set forth at page 23, lines 25-27 of the specification, 
and, as noted above, are further defined in Maniatis' Manual of Molecular Cloning. 
Consequently, the compositions of claim 33, as well as those of dependent claims 36, 
39, and 42, are adequately described to those of ordinary skill in the art. Applicants 



respectfullyTequesrtharthe~Examiner withdraw this-rejection-under-35-UrS7G-§-1 J l2 l 

first paragraph. 

The Examiner has further rejected claims 33, 36, 39, and 42 under 35 
U.S.C. § 1 12, second paragraph, as allegedly indefinite. Specifically, the Examiner 
contends that the specification fails to precisely define "stringent conditions." Applicants 
traverse. 

As set forth above, stringent hybridization conditions are precisely defined in the 
specification at page 23, lines 25-27. These conditions are recited as incubation at 65° 
in standard hybridization buffer and washing at 65° in 0.2X SSC, 0.1% SDS. As further 
noted above, Maniatis' Manual of Molecular Cloning is also referenced by the 

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PATENT 
Customer No. 22,852 
Attorney Docket No. 08702.0039-02000 

specification (at page 8, lines 3-9) as providing a detailed description of stringent 

hybridization conditions. Therefore, the term "stringent conditions" does not render 

claims 33, 36, 39, and 42 indefinite. Accordingly, Applicants respectfully request that 

the Examiner withdraw this rejection under 35 U.S.C. § 1 12, second paragraph. 

DOUBLE PATENTING REJECTIONS 

The Examiner has rejected claims 24-26, 29, 30, 33, 35, 36, 38, 39, 41 , and 42 
under the judicially created doctrine of obviousness-type double patenting as allegedly 
obvious over claims 1-7 of U.S. Patent No. 5,013,649. 

Filed concurrently with this Reply is a Terminal Disclaimer by Applicants' 
Assignee under 37 C.F.R. §1 .321(c) indicating that the '649 patent and the instant 
application are commonly owned. Applicants respectfully request that, in view of this 
Terminal Disclaimer, the rejection of the claims as unpatentable over the '647 patent be 
withdrawn. 

CONCLUSION 

In view of the foregoing amendments and remarks, Applicants respectfully 
requests reconsideration and reexamination of this application and the timely allowance 
of the pending claims. 



F I N N EG AN 
HENDERSON 
FARABO W 
GARRETT & 
DUNNERkL? 

1300 I Street, NW 
Washington, DC 20005 
202.408.4000 
Fax 202.408.4400 
www.finnegan.com 



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PATENT 
Customer No. 22,852 
Attorney Docket No. 08702.0039-02000 



Please grant any extensions of time required to enter this response and charge 

any additional required fees to Deposit Account No. 06-091 6. 

Respectfully submitted, 

FINNEGAN, HENDERSON, FARABOW, 
GARRETT & DUNNER, LLP. 



Dated: February 3, 2004 Zv YM^'ZC*^ Ivl^fl 

Elizabeth E. McNamee 



Elizabeth E. McN 
Reg. No. 54,696 



Attachments: Declaration under 37 C.F.R. § 1 .801-1 .809; 
Terminal Disclaimer 



FINNEGAN 
HENDERSON 
FARABOW 
GARRETT& 
DUNNERkif 

1 300 I Street, NW 
Washington, DC 20005 
202.408.4000 
Fax 202.408.4400 
www.finnegan.com 



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