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United States Patent and Trademark Office 




UNITED STATES DEPARTMENT OF^OMMERCE 
United States Patent and Trademark bfTice 

Address: COMMISSIONER FOR PATENTS 
P.O. Box 1450 

Alexandria, Virginia 22313-1450 
www.uspto.gDv 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



ATTORNEY DOCKET NO, 



CONFIRMATION NO. 



09/804,625 



03/09/2001 



Elizabeth A. Wang 



7590 



11/19/2004 



FINNEGAN, HENDERSON, FARABOW 
GARRETT AND DUNNER, LLP 
1300 1 STREET, N.W. 
WASHINGTON, DC 20005-3315 



5160C-CON 



2656 



EXAMINER 



ROMEO, DAVID S 



ART UNIT 



PAPER NUMBER 



1647 

DATE MAILED: 11/19/2004 



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



PTO-90C (Rev. 10/03) 





Application No. 


Applicant(s) 


Office Action Summary 


09/804,625 


WANG ET AL. 


Examiner 


Art Unit 






David S Romeo 


1647 





- 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 . 1 36(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 )[3 Responsive to communication(s) filed on 09 September 2004 . 
2a)n This action is FINAL. 2b)[3 This action is non-final. 

3) n 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 pa/te Qt/ay/e, 1935 CD. 11, 453 O.G. 213. 

Disposition of Claims 

4) [EI Claim(s) 24-26,29.30.33,35,36,38.39,41 and 42 is/are pending in the application. 

4a) Of the above claim(s) is/are withdrawn from consideration. 

5) 13 Claim(s) 26 and 30 is/are allowed. 

6) 13 Claimfs) 24.25,29,33,35,36.38.39 and 42 is/are rejected. 

7) 13 Claim(s) £/ is/are objected to. 

8) M Claim(s) 41_ are subject to restriction and/or election requirement. 

Application Papers 

9) 0 The specification is objected to by the Examiner. 

10) 0 The drawing(s) filed on is/are: a)n accepted or b)n 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). 
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d). 

1 1) 0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or fomri PTO-152. 

Priority under 35 U.S.C. § 11 9 

1 2) n Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 1 9(a)-(d) or (0. 
a)n All b)n Some * c)U None of: 

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

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

3.n 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. 



Attachment(s) 

1 ) M Notice of References Cited (PTO-892) 4) □ Interview Summary (PTO-413) 

2) □ Notice of Draftsperson's Patent Drawing Review (PTO-948) Paper No(s)/Mail Date. . 

3) □ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08) 5) □ Notice of Informal Patent Application (PTO-1 52) 

Paper No(s)/Mail Date . 6) □ Other: . 



3. Patent and Trade mari< Office 
rOL-326 (Rev. 1-04) 



Office Action Summary 



Part of Paper No./Mail Date 20041 1 



Application/Control Number: 09/804,625 Page 2 

Art Unit: 1647 

DETAILED ACTION 

The amendment filed 09/09/2004 has been entered. Claims 24-26, 29, 30, 33, 35, 36, 38, 
39, 41, 42 are pending. Claim 41 is withdrawn from further consideration pursuant to 37 CFR 
1 . 142(b) to the extent that it is drawn to a nonelected invention, there being no allowable generic 
5 or linking claim. Election was made without traverse in Paper No. 12. 

Maintained Formal Matters, Objections, and/or Rejections: 

Priority 

Applicant has not complied with one or more conditions for receiving the benefit of an 
10 earlier filing date under 35 U.S.C. 120 as follows: 

An application in which the benefits of an earlier apphcation are desired must contain a 
specific reference to the prior application(s) in the first sentence of the specification of in an 
application data sheet (37 CFR 1.78(a)(2) and (a)(5)). The specific reference to any prior 
nonpro visional apphcation must include the relationship (i.e., continuation, divisional, or 
15 continuation-in-part) between the applications except when the reference is to a prior application 
of a CPA assigned the same application number. 

Applicants' amendment to the specification has been considered. However, the reference 
to U. S- Application Nos. 943,532 and 880,776 does not include the relationship (i.e., 
continuation, divisional, or continuation-in-part) between the 943,532 and 880,776 appHcations 
20 and/or between the 943,532 and 880,776 applications and any other apphcation. Note that, 
according to 1268 OG 89 (18 March 2003), the following statement is improper: "This 
application is a continuing application of Application Nos. C, B, and A." On the other hand, the 



Application/Control Number: 09/804,625 Page 3 

Art Unit: 1647 

following statement is proper and acceptable: "This application is a continuation of Application 
No. C, filed - , which is a continuation of Application No. B, filed - , which is a continuation of 
Application No. A, filed - Note also that the reference to U. S. AppUcation No. 07/028,280 
appears to be an error. AppUcants may have intended to refer to U. S. Apphcation No. 
5 07/028,285. 



Claim Rejections "35 use §112 

Claims 33, 36, 39, 42 are rejected under 35 U.S.C. 1 12, second paragraph, as being 
indefinite for failing to particularly point out and distinctly claim the subject matter which 
10 applicant regards as the invention. Claim(s) 33, 36, 39, 42 are indefinite over the recitation of 
"stringent conditions." 

Applicants argue that stringent hybridization conditions are defined in the specification at 
page 23, lines 25-27 and in the enclosed copy of Maniatis. AppHcants also submit copies of six 
U. S. Patents containing claims reciting "stringent conditions." Applicant's arguments have been 

15 ftiUy considered but they are not persuasive. The specification at page 23, lines 25-27, discloses 
one set of hybridization conditions, and, as noted in the last Office action, stringency varies 
according to the hybridization conditions and the particular hybrid under study. It is unclear 
what conditions are intended. If Applicants intend the term "stringent hybridization conditions" 
to only encompass those conditions set forth at page 23, lines 25-27, of the present specification, 

20 then Applicants should not hesitate in amending the claims to recite those conditions. Regarding 
the six U. S. Patents cited by Applicants, suffice it to say that each case must be decided on its 
own merits based on the evidence of record. 



Application/Control Number: 09/804,625 Page 4 

Art Unit: 1647 

Claim 42 is rejected under 35 U.S. C. 112, second paragraph, as being indefinite for 
failing to particularly point out and distinctly claim the subject matter which apphcant regards as 
the invention. Applicant's arguments have been fully considered but they are not persuasive. 
Claim 42 is indefinite over the recitation of "bone morphogenetic protein-2." The recitation of 
5 "bone morphogenetic protein-2" is indefinite for the same reasons that the recitation of "BMP-2" 
is indefinite. Specifically, because the instant specification does not identify that material 
element or combination of elements which is unique to, and, therefore, definitive of "bone 
morphogenetic protein-2" an artisan cannot determine what additional or material limitations are 
placed upon a claim by the presence of this element. The metes and bounds are not clearly set 
10 forth. It is suggested that the claim recite "bone morphogenetic protein." 

Claims 24, 33, 35, 36, 38, 42 are rejected under 35 U.S.C. 1 12, first paragraph, as failing 
to comply with the written description requirement. The claim(s) contains subject matter which 
was not described in the specification in such a way as to reasonably convey to one skilled in the 
15 relevant art that the inventor(s), at the time the application was filed, had possession of the 
claimed invention. 

Applicants argue that allelic variants are clearly defined in the specification at page 7, 
lines 4-18; that the specification at page 8, lines 10-16, describes sequences that differ due to the 
degeneracy of the genetic code or allelic variations; that Applicants have enabled the skilled 
20 artisan to identify and isolate nucleotides encoding BMP-2 from natural sources, which would 
provide the claimed alleUc variants; that the term "allelic variant" is well understood in the art 
and Applicants cite 5 U. S. Patents, which claim allelic variants. Applicants' citation of U. S. 



Application/Control Number: 09/804,625 Page 5 

Art Unit: 1647 

Patent No. 5,586,388 (Method For Producing Multi-Board Electronic Device) appears to be an 
error. 

Applicant's arguments have been fijlly considered but they are not persuasive. The 
specification at page 7, lines 4-18, and at page 8, lines 10-16, only provides a vague, general 
5 description of potential allelic variation. Furthermore, the specification at page 7, lines 4-18, and 
at page 8, lines 10-16, indicates that allelic variation may give rise to amino acid variation. 
Thus, allelic variants, as contemplated by the present specification, are not limited to degenerate 
variants. Even if the term "allelic variants" was construed as only encompassing degenerate 
variants, the present disclosure would not satisfy the written description requirement of 35 

10 U.S.C. 1 12, first paragraph, because there is no specific description of the allelic variation that 
exist in nature, and there is no description of how the sequences in Figure 2 relate to the specific 
structure of any allele. The specification discloses only one allele within the scope of the genus: 
the nucleotide and amino acid sequence of figure 2. However, the general knowledge in the art 
concerning alleles does not provide any indication of how the structure of one allele is 

1 5 representative of unknown alleles. The nature of alleles is that they are variant structures, and in 
the present state of the art the structure of one does not provide guidance to the structure of 
others. Therefore, apphcants were not in possession of the claimed genus 

New Formal Matters, Objections, and/or Rejections: 
20 Priority 

Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the 
filing date of an earher filed U.S. application if the subject matter of the claim is disclosed in the 



Application/Control Number: 09/804,625 Page 6 

Art Unit: 1647 

manner provided by 35 U.S.C. 1 12, first paragraph in the earKer filed application. A 
polynucleotide comprising nucleotides 1202-1543 of Figure 2 or comprising nucleotides 
encoding amino acids 283 through 396 of Figure 2 was first disclosed in the manner provided by 
35 U.S.C. 1 12, first paragraph, in U. S. Application No. 07/721,847 (filed 06/14/1991). 
5 Accordingly, the effective filing date of the present claims that are directed to or encompass 
these embodiments is 06/14/1991. Should Applicants disagree, it is incumbent upon Applicants 
to provide the serial no. and specific place in any earher filed apphcation that specifically 
supports these embodiments. Furthermore, since the effective filing date of these embodiments 
is on or after October 1, 1990, the present apphcation must comply with the sequence rules. 

10 

The application is not fblly in compUance with the sequence rules, 37 C.F.R, § 1.821- 
1.825. Specifically, the claims fail to recite the appropriate sequence identifiers, i.e., "SEQ ID 
NO:", at each place where a sequence is discussed. This is not meant to be an exhaustive list of 
places where the specification fails to comply with the sequence rules. The specification has not 

1 5 been checked to the extent necessary to determine the presence of all possible minor errors. 
Applicant's cooperation is requested in correcting any errors of which applicant may become 
aware in the specification. The application cannot issue until it is in compliance. Nucleic acid 
sequences with 10 or more nucleotides, at least 4 of which are specifically defined, must comply 
with the sequence rules. Amino acid sequences with 4 or more residues, at least 4 of which are 

20 specifically defined, must comply with the sequence rules. Sequence identifiers can also be used 
to discuss and/or claim parts or fragments of a properly presented sequence. For example, 
language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need 



Application/Control Number: 09/804,625 Page 7 

Art Unit: 1647 

not be separately presented in the "Sequence Listing." Applicant may bring the figure(s) into 
compliance by amending either the figure(s) or the "Brief Description of the Drawings" to recite 
the appropriate sequence identifier. 
Correction is required. 

Claim Rejections - 35 USC§ 102 
The following is a quotation of the appropriate paragraphs of 35 U.S. C. 102 that form the 
basis for the rejections under this section made in this Office action: 
A person shall be entitled to a patent unless - 

(b) the invention was patented or described in a printed pubUcation in this or a foreign country or in pubhc use or on 
sale in this country, more than one year prior to the date of appHcation for patent in the United States. 

-Claims 24, 25, 29, 33, 35, 36, 38, 39, 42 are rejected under 35 U.S.C. 102(b) as being 
anticipated by Wozney (U). 

This rejection is based upon an effective filing date of 06/14/1991 for claims that are 
directed to or encompass a polynucleotide comprising nucleotides 1202-1543 of Figure 2 or 
comprising nucleotides encoding amino acids 283 through 396 of Figure 2. 

Wozney discloses an isolated nucleic acid molecule, a vector comprising the isolated 
nucleic acid molecule in operative association with an expression control sequence, a host cell 
transformed with the vector, and a method comprising culturing the host cell and recovering the 
encoded polypeptide (paragraph bridging pages 1530-153 1). Wozney's isolated nucleic acid 
molecule comprises nucleotides 1202-1543 of Figure 2 and comprises nucleotides encoding 
amino acids 283 through 396 of Figure 2, as indicated below (Qy = Figure 2 sequences) (Db = 
Wozney's sequences): 

Query Match 100.0%; Score 342; DB 9; Length 1547; 



Application/Control Number: 09/804,625 



Pages 



Art Unit: 1647 



Best Local Similarity 100.0%; Pred. No. 2.9e-103; 

Matches 342; Conservative 0; Mismatches 0; Indels 0; Gaps 0; 

CAAGCCAAACACAaaCAGCGGftAACGCCTTAAGTCCAGCTGTAAGAGACACCCTTTGTAC S 0 

IMIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIMIIIIIIIIIIIIIMIIIIIMMI 



lllllllllllllllllllllllllllllllllllllllllllllllllllllll 



TTTTACTGCCACGGAGAATGCCCTTTTCCTCTGGCTGATCATCTGAACTCCACTAATCAT 18 0 

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 n 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

TTTTACTGCCACGGAGAATGCCCTTTTCCTCTGGCTGATCATCTGAACTCCACTAATCAT 1349 



lllllllllllllllllllllllllllllllllllllllllllllllllllllllllll 

135 0 GCCATTGTTCAGACGTTGGTCAACTCTGTTAACTCTAAGATTCCTAAGGCATGCTGTGTC 14 09 

CCGACAGAACTCAGTGCTATCTCGATGCTGTACCTTGACGAGAATGAAAAGGTTGTATTA 3 00 

IIIMIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIMII 

CCGACAGAACTCAGTGCTATCTCGATGCTGTACCTTGACGAGAATGAAAAGGTTGTATTA 14 6 9 



Qy 


1 


Db 


1170 


Qy 


61 


Db 


1230 


Qy 


121 


Db 


1290 


Qy 


181 


Db 


1350 


Qy 


241 


Db 


1410 


Qy 


301 


Db 


1470 



lllllllllllllllllllllllllllllllllllllllll 



Query Match 100.0%; Score 634; DB 1; Length 396; 

Best Local Similarity 100.0%; Pred. No. 5.1e-58; 

Matches 114; Conservative 0; Mismatches 0; Indels 0; Gaps 0; 

Qy 1 QAKHKQRKRLKSSCKRHPLYVDFSDVGWNDWIVAPPGYHAFYCHGECPFPLADHLNSTNH 6 0 

llllllllllllllllllllllllllllllllllllllllllllllllllllllllllll 
Db 283 QAKHKQRKRLKSSCKRHPLYVDFSDVGWNDWIVAPPGYHAFYCHGECPFPLADHLNSTWH 342 

Qy 61 AIVQTLVNSVNSKIPKACCVPTELSAISMLYLDENEKWLKNYQDMWEGCGCR 114 

IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIMIIIIIIIIIIIIIIIIIIIII 

Db 343 AIVQTLVNSVNSKIPKACCVPTELSAISMLYLDENEKWLKNYQDMWEGCGCR 3 96. 



Claim Objections 

Claims 33, 36, 39, 42 are objected to under 37 CFR 1.75(c), as being of improper 
dependent form for failing to further limit the subject matter of a previous claim. Applicant is 
required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent 
form, or rewrite the claim(s) in independent form. A polynucleotide that hybridizes to a 
polynucleotide complementary to a polynucleotide of claim 24, as recited in claim 33, fails to 
further limit a polynucleotide of claim 24 because the hybridization language encompasses 



Application/Control Number: 09/804,625 
Art Unit: 1647 



Page 9 



nucleotide insertions, substitutions, deletions, additions and combinations of each of the forgoing 
with respect to a polynucleotide of claim 24. 

Claim 41 is objected to the extent that it is directed to a nonelected invention. 



Claims 26 and 30 are allowable. 

Any inquiry concerning this communication or earlier communications from the examiner should be directed to 
David S. Romeo whose telephone number is (571 ) 272-0890. The examiner can normally be reached on Monday through 
Friday from 7:30 a.m. to 4:00 p.m. If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Brenda Brumback, can BE reached ON (571)272-0961. 

IF submitting official correspondence BY fax. Applicants are encouraged to submit official correspondence to 
THE following TO 1600 Before and After Final RightFax numbers: 

Before Final (703) 872-9306 

After Final (703) 872-9307 

Customers are also advised to use Certificate of Facsimile procedures when submitting a reply to a non-final 
or final Office action by facsimile (see 37 CFR 1 .6 and 1 .8). 

Faxed draft or informal communications should be directed to the examiner at (571 ) 273-0890. 

Any inquiry of a general nature or relating to the status of this application or proceeding should be directed 
to the Group receptionist whose telephone number is (703) 308-01 96. 



Conclusion 




David Romeo 
Primary Examiner 
Art Unit 1647 



DSR 

November 18, 2004