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IN THE UNITED STATES PATENT AND TRADEMARK OFFICE 



APPLICANT: Wang et al 

SERIAL NO. : 07/179,100 

FILED: April 8, 1988 

TITLE: DNA SEQUENCES 
ENCODING 
OSTEOINDUCTIVE 
PRODUCTS 



COP 



GROUP ART UNIT: 18 5 
EXAMINER: J. Ellis 



December 12, 1990 



Commissioner of Patents and Trademarks 
Washington, D.C. 2 0231 

INFORMATION DISCLOSURE STATEMENT 

Dear Sir: 

Applicants do not consider that the information listed is 
material to the patentability of the present invention. However, 
to ensure compliance with 37 CFR 1.56 and 1.97 Applicants wish to 
make this information of record. The documents described below are 
listed on accompanying PTO Form 1449 and a copy of each (otherwise 
noted) accompanies this statement. The full copies accompany the 
"Express Mail" copy. 

Sen, US Patent 4,804,744 is understood to disclose a family 
of immunologically related osteogenic factors extracted from 



• „ k a , r iv The disclosed amino acid sequences of 

demoralized bone matrix. The a Drote ins encoded ., 

j *. anv homology with the proteins 

these factors do not share any ^-r ;j QT .«ri 

Ty fences of the present invention and are therefore con id red 
to be different proteins. Sen, European Publication 148155 not 
Closed) corresponds to the above-described US Patent 4,804,744. 

Se^edin et al , US Patents 4,774,228, 4,774,322, 4,810,691 and 
4 843^Isclose two cartilage-inductive factors (CIFS) These 
pictens have been characterized as TGF-B proteins. The disclosed 
amino acid sequences of these factors are different from the 
osteogenic proteins encoded by the DNA sequences of the present 
invention. European Publication 169016 (not enclosed) corresponds 
to these US patents 4,774,228 and 4,774,322. 

s» Y ""n and Thomas , US Patent 4,434,094 discloses a process 
for partially purifying osteogenic factor from demoralized bone 
particles. The recovered fraction is less than or equal to 30,000 
daltons. The proteins of the above identified patents '228 and 
•322 were purified to homogeneity using a purification procedure 
similar to that disclosed in 4,434,094 (see column 1, lines 50-62 
of ' 228 and ' 322) . 

sevadin and Thomas , US Patent 4,627,982 is understood to 
disclose a process for obtaining a partially purified proteinaceous 
bone inducing material containing proteins of molecular weight 
10,000 to 30,000 daltons. 

Nathan et al, U.S. Patent 4,563,350 discloses a composition 
which is a mixture containing an osteogenic factor (OF) protein 
derived from bone sufficiently free from impurities so as to be 
hypo immunogenic. Nathan refers to a process described in Serial 
No. 63 0,93 8 for preparing OF. The above-described '228 and' 3 22 
patents disclose that the proteins described in 630,938 have been 
further described as TGF-b proteins. 



3 



tlathari .t al. European Publication 0336760 
osteogenically active protein. The protein sequence does not e 
homology with the proteins encoded by the ONA sequences o. 

present invention • 

urist, us Patent 4,294,753 is understood to disclose a process 
of separating bone mcrphogenic protein (BMP) from bone tissue, 
urist US Patent 4,455,256 which is cumulative to '753 discloses the 
isolation of a mixture of proteins having a molecular weight of 

1,000-100,000 daltons. 

Urist, US Patent 4,761,471 and 4,789,732 are divisional of 
Urist 4,619,989 previously discussed during prosecution. The 
disclosure in each of these patents is the same as in '989. '471 
and -732 claim a process and product for inducing bone formation. 
The product includes a BMP factor capable of inducing bone 
formation and at least one associated protein incapable of inducing 
bone formation independent of the BMP factor. The isolation and 
identification of the proteins encoded by the DNA of the present 
invention are not enabled by this disclosure. 

Urist et al, Science 220 : 630-686 (1983) reviews progress in 
the field of bone cell differentiation and growth factors. 

Caolan and Svftestad , US Patent 4,608,199 discloses a process 
of extracting and purifying a bene protein capable of stimulating 
chondrogenesis. This protein is water soluble and acidic unlike 
that encoded by sequences of the present invention. 

Nathanson et al, US Patent 4,631,763 is understood to disclose 
a method of recovering a material capable of inducing new bone and 
cartilage. This material is broadly characterized as an extract 
of demineralized bone and is deposited by precipitation onto a 
pliable support. 



4 



Sampath et al, PNAS , 84: 7109-7113 (1987) discloses isolation 
of a bone inductive protein having an apparent molecular weight of 
22,000 daltons. Sequence information is not disclosed. 

Evans et al, US Patent 4,737,578 discloses human inhibin. 
Proteins encoded by sequences of the present invention do share 
some homology with the inhibins, however they are different 
molecules. 

Mason and Seebura , US Patent 4,798,885 is also directed to 
human inhibin. Proteins encoded by sequences of the present 
invention do share homology with the inhibins, but are different 
molecules. 

The present application claims filing dates which are earlier 
than the filing dates of the following references. 

Kuberasampath and Rueaer , U.S. Patent 4,968,590 contains 
bovine amino acid sequence of BMP-2 (see claim 11 of '590 and in 
the present application see Table I amino acids #98-#110) which is 
also present in human BMP-2 (see Table II amino acids #3 65-#377 of 
the present application), '590 does not teach or suggest the DNA 
sequences of the present invention" and" is- not- pertinant _to . the 
patentabilty thereof. This patent was filed on the same day as 
the present application and does not claim the benefit of any 
earlier filing dates as does the present application. 



Qpoermann et al, WO89/09788 Kuberasampath et al, 

WO89/09787 realted to U.S. '590 discussed in the preceding 
paragraph disclose osteogenic proteins and devices, DNA sequences 
of the present invention are not disclosed. 

Parsons et al, WO90/03733 discloses an osteogenically active 
protein. Amino acid sequence information is disclosed which 
corresponds to amino acid sequence of BMP-2 (BMP-2A) and BMP-4 
(BMP-2B) . DNA sequences as claimed in the present invention are 
not disclosed. 



Respectfully submitted, 



Genetics Institute, Inc. 
87 CambridgePark Drive 
Cambridge, MA 02140 
(617) 876-1170 X406 
telefax (617)876-5851 




Ellen J. Kapinos 
Reg. No. 32,245 
Attorney for Applicants 



ek/5071HIDS 




GZ 5160C 

IN THE TJNTTED STATES PATENT AND TRADEMARK OFFTCB 



Applicants 
Serial No. 
Filed 
For 



E. Wang et al. , 

07/721,847 Examiner : K FURMAN 

14 JUNE 1991 Art Unit : 1814 
Novel BMP PRODUCTS 



February 15, 1993 

Ken. co^ioner « S^^^^SsL, 

Patents and Trademarks ir££ii^^ 
Washington, DC 20231 ^7//^) O. na&£%L 




Sir: 

INFORMATION DISCLOSURE STATEMENT 

In accordance with the provisions of 37 C.F.R. SS 1.56 and 
1.97, and 1.98(d) the publications and/or patents listed on the 
attached form PTO-1449 are cited for consideration by the Examiner 
in connection with the examination of the above-identified patent 
application. It is understood that the references need not be 
provided herewith as they have been previously submitted to the 
Office in the prior parent application. 

In accordance with the provisions of 37 C.F.R. SI. 97, this 
statement is being filed (CHECK ONE) : 

(1) within three (3) months of the Filing Date or before 

the mailing date of the First Offioe Action on the 
merits; or 

XX (2) after the period defined in (1) but before the 

mailing date of a Final Rejection or 
Notioe of Allowance, and the requisite 
Certification or fee under Rule l.l7(p), namely 
$200.00, is included herein; or 
(3) after the mailing date of a Final Rejection or 
Notice of Allowance but before the payment of the 
Issue Fee, and the requisite Certification, 
petition, and petition fee are included herein. 






WANG ET AL 
USSN 07/721,847 
February 15, 1993 
PA6E2 



It is respectfully requested that each of the documents shown 
on the attached form PTO-1449 be made of record In this 
application. 

The Commissioner is authorized to charge the $200.00 fee to 
our Deposit Account, No. 07-1060 and any additional fees deemed 
necessary to said Deposit Account. 



Respectfully submitted, 



Ellen J. Kapinos ■ 
Reg. No. 32,245 
Attorney for Applicants 

(617) -876-1170 




Gl5071HDIVjifa 

Applicants : Elizabeth Wang, John Wozney, Vicki Rosen 



Serial No. 
Filed 
For 

March 2, 1993 



07/655,579 

March 18, 1991 

NOVEL BMP-2 PRODUCTS 



Examiner 
Art Unit 



: M.Allen 
: 1812 



COPY 



Hon. Commissioner of 

Patents and Trademarks 
Washington, DC 20231 

Sir: 



I harafay certify that tfiis corrapofxtefles is beinu 
deposited with tha Un&ad States Postal Sanrie* as 
first clan mall in an anvotopa arfdrassad to Com- 
missioner of Pitanta and trademarks. Washing; 
ton, 0.C2O231. m .,^?77rW/7 f>, fYft? 



INFORMATION DISCLOSURE STATEMENT 
In accordance with the provisions of 37 C.F.R. 5§ 1.36 and 1.97, 1.98(d) the 
publications and/or patents listed on the attached form PTO-I449 are cited for consideration by 
the Examiner in connection with the examination of the above-identified patent application. It 
is understood that the references need not be provided herewith as they have been previously 
submitted to the Office in the prior parent application. 

In accordance with the provisions of 37 C.F.R. §1.97, this statement is being tiled 

(CHECK ONE): 

(1) within three (3) months of the Filing Date or before the mailing date of the First 

Office Action on the merits; or 
XX (2) after the period defined in (1) but before the mailing date of a Final Rejection 

or Notice of Allowance, and the requisite Certification or fee under Rule 1 . 1 7(p), 

namely $200.00, is included herein; or 
(3) ~ after the mailing date of a Final Rejection or Notice of Allowance but before the 

payment of the Issue Fee, and the requisite Certification, petition, and petition 

fee are included herein. 



2 i, respectfully requested that each of the documents shown on the attached form PTC 
1449 be made of record in this application. 

Early examination and allowance of the present application are respectfully solicited. 

Should any fee associated with the submission of this paper not be attached hereto as a 
check, the Commoner is authorized to charge the missing fee to our Deposit Account, No. 
07-1060. Any overpayments should be credited to said Deposit Account. 

Respectfully submitted, 

Legal Affairs /%&D ^ /^t^S 

Genetics Institute, Inc. . y 

87 CambridgePark Drive Hten J • ^f?* 

Cambridge, Massachusetts 02140 Reg- 32,245 

Attorney for Applicants 

(617>876-1170 



. canify thai tnis paper or fee is being 
^:tc<3 with the United States Postal Service 

..itsa Mail Post Office to Addressee" service 
:-.*nr 37 C.f.fl.i. 10 on the date indicated abovs 
o. is addressed to die Commissioner of Patents 
3 rcademarks. Washington. 0.C- 20231 



GI5160 



IN THE UNITED STATES PATENT AND TRADEMARK OFFICE 



APPLICANT: Wang et al 

SERIAL NO.: 07/378,537 

FILED: July 11, 1989 

TITLE: DNA SEQUENCES 
ENCODING 
OSTEOINDUCTIVE 
PROTEINS 




GROUP ART UNIT: 185 
EXAMINER: J. Ellis 



October 7, 1991 



Commissioner of Patents and Trademarks 

Washington, D.C. 20231 # 

INFORMATION DISCLOSURE STATEMENT 

Dear Sir: 

The following documents are submitted pursuant to37 CFR 1.56 
and* 1.97. The documents described below are listed on accompanying 
PTO Form 1449 and copies of the references are submitted herewith. 

Sen , US Patent 4,804,744 is understood to disclose a family of 
immunologically related osteogenic factors extracted from 
demineralized bone matrix. The disclosed amino acid sequences of 
these factors do not share any homology with the proteins encoded 
by sequences of the present invention and are therefore considered 
to be different proteins. Sen, European Publication . 148155 (not 
enclosed) corresponds to the above-described US Patent 4,804,744. 

Sevedin et al, US Patents 4,774,228, 4,774,322, 4,810,691 and 
4,843,063 disclose two cartilage-inductive factors (CIFS) . These 
proteins have been characterized as TGF-B proteins. The disclosed 
amino acid sequences of these factors are different from the 



Wang' et al 
USSN 07/378,537 
Page 2 

osteogenic proteins encoded by the DNA sequences of the present 
invention . European Publication 169016 (not enclosed) corresponds 
to these US patents 4,774,228 and 4,774,322. 

Seyedin and Thomas . US Patent 4,434,094 discloses a process 
for partially purifying osteogenic factor from demineralized bone 
particles. The recovered fraction is less than or equal to 30,000 
daltons. The proteins of the above identified patents '228 and 
•322 were purified to homogeneity using a purification procedure 
similar to that disclosed in 4,434,094 (see column 1, lines 50-62 
of '228 and '322) . 

-S-ev-ed-in— and- -Thomas- - US Patent 4 , 627 .982 is understood to 
disclose a process for obtaining a partially purified proteinaceous 
bone inducing material containing proteins of molecular weight 
10,000 to 30,000 daltons, 

Nathan et al, U.S. Patent 4,563,350 discloses a composition 
which is a mixture containing an osteogenic factor (OF) protein 
derived from bone sufficiently free from impurities so as to be 
hypo immunogenic. Nathan refers to a process described in Serial 
No. 630,938 for preparing OF. The above-described '228 and'322 
patents disclose that the proteins described in 630,938 have been 
further described as TGF-b proteins. 

Nathan et al, European Publication 0336760 discloses an 
osteogenically active protein. The protein sequence does not share 
homology with the proteins encoded by the DNA sequences of the 
present invention. 

Urist, US Patent 4,294,753 is understood to disclose a process 
of separating bone morphogenic protein (BMP) from bone tissue. 
Urist US Patent 4,455,256 which is cumulative to f 753 discloses the 



Wang'et al 
USSN 07/378,537 
Page 3 

isolation of a mixture of proteins having a molecular weight of 
1,000-100,000 daltons. 

Urist, US Patent 4,761,471 and 4,789,732 are divisionals of 
Urist 4,619,989. A BMP factor capable of inducing bone formation 
and at least one associated protein incapable of inducing bone 
formation independent of the BMP factor are disclosed. The 
isolation and identification of the proteins encoded by the DNA of 
the present invention are not enabled by this disclosure. 

Urist et al, Science 220 : 68 0-686 (1983) reviews progress in 
the field of bone cell differentiation and growth factors. 

' Caplan a nd Svf testad . us Patgntji^ fina r i igg discloses a process 

of extracting and purifying a bone protein capable of stimulating" 
chondrogenesis. This protein is water soluble and acidic unlike 
that encoded by sequences of the present invention. 

Nathanson et al, US Patent 4,681,763 is understood to disclose 
a method of recovering a material capable of inducing new bone and 
cartilage. This material is broadly characterized as an extract of 
demineralized bone and is deposited by precipitation onto a pliable 
support . 

Sampath et al, PNAS . 84: 7109-7113 (1987) discloses isolation 
of a bone inductive protein having an apparent molecular weight of 
22,000 daltons. Sequence information is not disclosed. 

Evans et al, us Patent 4,737,578 discloses human inhibin. 
Proteins encoded by sequences of the present invention do share 
some homology with the inhibins, however they, are different 
molecules. 



son and Seebin-^ us Patent 4,798,885 is also directed to 



Wang et al 
USSN 07/378,537 

page 4 

hu *an inhibin. Proteins encoded by se^ences of the .present 
invention do share homology with the inhiiins, but are deferent 

molecules . 

^u„.,„ r ,M, ,nd Rueaer . U.S. Patent 4,968,590 discloses 
bovine amino acid sequence of BMP-2A(BMP-2) (see claims 9, 10 and 
12) '590 does not teach or suggest the DNA sequences of the 

present invention and is not pertinent to the patentability 
thereof. 

Qppermann et al, WO89/09788 and Kuberasampath et al, 
WO89/09787 related to U.S. '590 discussed in the preceding 
paragraph "disclose osteogfenrc-prote-i-ns-and_devices . _ DNA _sequences^ 
of the present invention are not disclosed. 

Parsons et al, WO90/03733 discloses an osteogenically active 
protein. Amino acid sequence information is disclosed which 
corresponds to amino acid sequence of BMP- 2 A (BMP-2) and BMP-2B 
(BMP-4) . DNA sequences as claimed in the present invention are not 
disclosed. 

TAivten et al . .T. Biol. Chem. 264:13377-13380 (1989) discloses 
osteogenin having amino acid sequences homologous to BMP-3 . In 
fact, the end of the article notes the publication of Applicants' 
Science 242 ; 1528-1534(1988) article which published after the 
submission of the Luyten manuscript. 

Qppermann et al . U.S. 5,011,691 is understood to be directed 
to osteogenic - devices. BMP-2A amino acid sequence is disclosed, 
but their is no disclosure of the BMP DNA sequences of the present 
invention. 



Kiefer et al . EP 409472 Al discloses a protein which does 



Wang et al 
USSN 07/378,537 
Page 5 

share homology with BMP-2A (BMP-2) or BMP-2B (BMP-4) . This protein 
is noted however to share homology with the protein claimed in Sen 
EP0148155 discussed above. 

Bentz et al . WO91/02744 discloses a purported bone-specific 
protein which does not share homology with BMP-2A ( BMP-2 ) or BMP- 
2B(BMP-4) . 

Murakami et al , EP416578A2 discloses Xenopus laevis bone 
morphogenic protein. 

Qppermann et al . WO91/05802 is directed to an osteogenic 
protein, OP-1, which differs from BMP-2A(BMP-2) and BMP-2 B ( BMP-4 ) . 

Kiefer . CA 2,017,466 discloses bone calcification factor which 
does not share homology with BMP— 2 A ( BMP-2 ) or BMP-2 B (BMP-4) . 



Respectfully submitted, 



Genetics Institute, Inc. 
87 CambridgePark Drive 
Cambridge, MA 02140 
(617) 876-1170 X480 
fax (617)876-5851 




Reg. No. 32,245 
Attorney for Applicants 



ek/5160IDS