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Full text of "USPTO Patents Application 09804625"

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


Claims 24, 26, 30, 33, 35, 36, 38, 39, 41 , and 42 are pending in the application. 
Applicants thank the Examiner for acknowledging the allowance of claims 24, 26, 30, 
35, 38, and 41. 

The rejection of claims 33, 36, 39, and 42 under 35 U.S.C. § 102(b) is standing. 
Claim 33 is currently amended, and the language is virtually identical to that of claim 33 
prior to the amendment of February 1 8, 2005. Thus, no new matter has been added by 
this amendment. Applicants submit that the proposed amendment of claim 33 is 
sufficient to overcome the rejection of claims 33, 36, 39, and 42. 


Applicants thank the Examiner for the courtesies extended in the telephone 
interview of October 7, 2005. In the interview, the undersigned and the Examiner 
discussed that the correct copy of Maniatis et al.. Molecular Cloning (A Laboratory 
Manual), Cold Spring Harbor Laboratory (1982) had not yet been submitted to the 
Examiner. Certain discrepancies between the specific hybridization conditions 
disclosed in the previously pending claims and those disclosed in Maniatis and in 
Example 5 of the current specification were also discussed. 


I. Priority Claim 

Applicants have amended the first paragraph of the specification to reflect the 
correct priority claim. Specifically, Applicants have removed any claim to priority from 
applications filed prior to April 8, 1 988. Accordingly, the effective filing date of this 



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

application should now be April 8, 1 988, and the pending claims are all entitled to this 

priority date. 

II. Hybridization Conditions 

Applicants have amended the paragraph beginning at page 7, line 35, to insert 
the hybridization conditions disclosed in Maniatis et al.. Molecular Cloning (A Laboratory 
Manual), Cold Spring Harbor Laboratory (1982) at pages 387 to 389 ("Maniatis"), cited 
in the application as filed. A copy of these pages is enclosed to demonstrate that these 
are the only hybridization conditions disclosed in those pages of the Maniatis reference 
manual. Applicants also include an affidavit executed by the undersigned stating that 
the amendatory material consists of the same material incorporated by reference to 
Maniatis. See Manual of Patent Examining Procedure, § 608.01 (p). Although 
Applicants do not concede that this information is "essential" because one of skill in the 
art would readily understand the term "stringent hybridization conditions" as described in 
Maniatis, in order to expedite prosecution of this application, Applicants have amended 
the specification to incorporate this specifically referenced material. 


Claims 33, 36, 39, and 42 have been rejected under 35 U.S.C. § 102(b) as 
allegedly anticipated by Wozney, Science 242(4885):1 528-1 534 (1988) ("Wozney"). 
The Examiner contends that Applicants are not entitled to claim priority to U.S. Serial 
No. 07/179,100 ("'100 application"; now U.S. Patent No. 5,013,649), filed April 8, 1988, 
alleging that the hybridization conditions described in the claims are not disclosed in the 
'100 application, or in any later-filed application. 


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

I. The Amended Claims 

Applicants have amended claim 33 to remove the specific hybridization 
conditions from the claims, and have replaced this language with the language 
"stringent hybridization conditions." Applicants had inserted the specific conditions in 
the claims after the Examiner indicated that this amendment would help overcome a 
rejection under 35 U.S.C. § 1 12, second paragraph (O.A. of 1 1/19/04; p.3). However, 
after discussing this claim at length with the Examiner during the interview of 
October 7, 2005, and after a review of PTO Examination Guidelines, Applicants have 
concluded that the term "stringent hybridization conditions" sufficiently defines the 
invention to comply with 35 U.S.C. § 112, second paragraph. 

Specifically, the claim term "stringent hybridization conditions" is described in the 
current specification (page 8, lines 3-9) and the '100 application (page 5, lines 6-15) as 
being those conditions disclosed in Maniatis et al.. Molecular Cloning (A Laboratory 
Manual), Cold Spring Harbor Laboratory (1982), pages 387 to 389. The relevant pages 
of Maniatis provide a specific protocol for DNA hybridization with the following 
conditions — which Applicants specifically define as stringent conditions in the 

(1 ) prehybridization of a filter for 2-4 hours at 68°C in 
prehybridization solution (6X SSC, 5X Denhardt's 
solution, 100 /vg/ml denatured salmon sperm DNA); 

(2) hybridization for either 3-4 hours (cloned DNA) or 1 2- 
16 hours (total eukaryotic DNA) at 68°C in 
hybridization solution (6X SSC, 0.01 M EDTA, 0.5% 
SDS, 1 00 jjQ/m\ denatured salmon sperm DNA, 
labelled DNA probe); 


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

(3) wash at at 68°C with 2X SSC and 0.5% SDS, then 2X 
SSC and 0.1% SDS, then 0.1 X SSC and 0.5% SDS. 

As discussed above, these conditions have now been inserted into the specification. 
These conditions were well known as of the earliest priority date of this application 
(April 8, 1988), evidenced in part by the fact that the referenced version of Maniatis was 
published in 1982, six years before the filing date of the '100 application. It is 
incontrovertible that Maniatis was (and still is) a ubiquitous laboratory reference manual 
and a primary source for DNA hybridization protocols such as the one described above. 
Thus, by referencing Maniatis, the application is describing to one of ordinary skill in the 
art the exact definition of the claimed stringent hybridization conditions. 

II. The claims are adeauatelv described in the specification of the earliest priority 

The basis of the Examiner's rejection under 35 U.S.C. § 102(b) is the contention 
that the claims are not adequately described in the '100 application, and thus. 
Applicants are not entitled to claim priority to the April 8, 1988 filing date of that 
application. The written description requirement serves to demonstrate that the 
applicant was in possession of the invention that is claimed. In re Barker, 559 F.2d 588, 
592 n.4 (CCPA 1977) (the goal of the written description requirement is "to clearly 
convey the information that an applicant has invented the subject matter which is 
claimed"). Generally, there is an inverse correlation between the level of skill and 
knowledge in the art and the specificity of disclosure necessary to satisfy the written 
description requirement. Information that is well known in the art need not be described 


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

in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 

802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). 

In thie instant specification, applicants have referred to an established protocol in 

an extremely well-known laboratory manual to describe the conditions used to isolate 

sequences that hybridize to the complement of the sequence of Figure 2. Thus, the 

hybridization conditions are "well known in the art," as defined by Hybritech. By 

reference to precise hybridization conditions disclosed in Maniatis, the application 

clearly defines the term "stringent hybridization conditions," and demonstrates 

possession of those nucleotide sequences that would hybridize to the sequence of 

Figure 2. 

This conclusion is supported by the holding in Vas-Cath, which states that if a 
skilled artisan would have understood the inventor to be in possession of the claimed 
invention at the time of filing, then the adequate description requirement is met, even if 
every nuance of the claims is not explicitly described in the specification. Vas-Cath v. 
Mahurkar, 935 F.2d 1 555, 1 563, 1 9 USPQ2d 1111,1116 (Fed. Cir. 1 991 ). Because 
Maniatis is such a well-known reference manual, one of skill in the art would understand 
that reference to this manual adequately described the conditions of the Maniatis 
hybridization protocol. Accordingly, Applicants submit that the claimed nucleotide 
sequences are described in the earliest priority document (the '100 application), and in 
every subsequent application filed up to the current specification, simply by the 
reference to the stringent hybridization conditions disclosed in Maniatis. 

- 10- 

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


In view of Xhe foregoing amendments and remarks, Applicants submit that 
Wozney, published in December, 1988, after the April 8, 1988 filing date of the '100 
application, is not prior art to this application and the rejection under 35 U.S.C. § 102(b) 
should be withdrawn. Applicants respectfully request reconsideration and 
reexamination of this application and the timely allowance of the pending claims. 

Please grant any additional extensions of time required to enter this response 

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

Respectfully submitted, 


Dated: November 1 6, 2005 

By: fXtUj u^ t h Ml ^^ 

Elizabeth E. Mathiesen 
Reg. No. 54,696 


• Maniatis et al.. Molecular Cloninc (A Laboratory Manual) . Cold Spring Harbor 
Laboratory (1982), pages 387-389; 

• United States Application Serial No. 07/179,100: and 

• Affidavit under M.P.E.P § 608.01 (p). 


E V 684956338 US November 1 6, 2005 

USPS Express Mail Label Number Date of Deposit 

I hereby certify that this correspondence is being deposited with the United States Postal Services "Express Mail Post Office to Addressee* service 
under 37 CFR § 1 .1 0 on the date indicated above and Is addressed to the Commissioner for Patents, P.O. Box 1 450, Alexandria, VA 2231 3-1 450. 

Katherine L. Staba ^ '