Skip to main content

Full text of "USPTO Patents Application 09864621"

See other formats


Application No.: 09/864,621 



6 



Docket No.: 4414720001 10 



REMARKS 

Claims 1-28 were pending in the present application. Claims 1-1 1 are rejected and claims 
12-28 are withdrawn from consideration. Claim 1 has been amended. Support for this amendment 
is found throughout the specification. For example, support for this amendment may be found at 
page 9, lines 1-5. Thus, no new matter has been added by this amendment. 

With respect to all amendments and cancelled claims (and/or subject matter related thereto). 
Applicants have not dedicated or abandoned any unclaimed subject matter and moreover have not 
acquiesced to any rejections and/or objections made by the Patent Office. Applicant reserves the 
right to pursue prosecution of any such subject matter in future continuation and/or divisional 
application. 

Also, filed herewith is a Petition for Revival of an Application for Patent Abandoned 
Unintentionally under 37 CFR 1.137(b), as well as the petition fee. Reconsideration and allowance 
of the pending claims in view of the remarks presented herein, is respectfully requested. 

Reconsideration and allowance of the pending claims in view of the remarks presented 
herein is respectfully requested. 

Rejections under 35 U^S.C. 112 § 112, First Paragraph 

The Office has rejected claims 1-1 1 under 35 U.S.C. 112, first paragraph, for allegedly 
failing to comply with the written description requirement. Applicant respectfully traverses this 
rejection for the reasons provided below. 

The Examiner's contends that the chemical compounds lack "..common chemical 
structures, chemical activities, and biological functions" and therefore "..alterations in gene 
expression or protein expression in various mammalian embryoid bodies responding to numerous 
different chemical compositions would not be predictable at the time of the invention." (Office 
Action, page 3). Applicant respectfully submits that the instant specification fully complies with the 
written description requirement. Moreover, Applicant notes that claims 1-11 are product by process 
claims. Accordingly, Applicant does not need to define the products in terms of structural 

pa-9 12400 



'Application No.: 09/864,621 



7 



Docket No.: 4414720001 10 



characteristics. See, e.g., Atlantic Thermoplastics v. Favtex Corp. , 970 F.2d 834, 844 (Fed. Cir. 
1992). Withdrawal of this rejection is respectfully requested. 

The Office has rejected claims 1-1 1 under 35 U.S.C. 112, first paragraph, for allegedly 
failing to comply with the enablement description requirement. Applicant respectfully traverses this 
rejection for the reasons provided below. 

The Examiner's contends that the chemical compounds "..include numerous different 
chemical compounds having different chemical structures, physical properties, and biological 
functions" and therefore "..alterations in gene expression or protein expression in various 
mammalian embryoid bodies responding to numerous different chemical compositions would not be 
predictable at the time of the invention." (Office Action, page 5). Applicant respectfully submits 
that the instant specification fully complies with the enablement requirement. Moreover, as 
discussed above, claims 1-11 are product by process claims. Accordingly, Applicant does not need 
to define the products in terms of structural characteristics. See, e.g., Atlantic Thermoplastics v. 
Favtex Corp. , supra. Withdrawal of this rejection is respectfully requested. 

Rejections under 35 U.S.C. §103 

Claims 1-1 1 are rejected under 35 U.S.C. 103(a) as allegedly being unpatentable over 
over Spielmann et al., 1997 (In Vitro Toxicology, Vol. 10, No. 1, p. 119-127) in view of Craig et al., 
1996 (Biomarkers, Vol. 1, No. 2, p. 123-135) and Wobus et al, 1999 (US Patent 6,007,993). The 
Examiner alleges, that 

. .it would have been obvious for one of ordinary skill at the time of 
the invention to substitute the MTT cytotoxicity assay as taught by 
Spielmann with detection of gene expression as taught by Craig or 
detection of protein expression as taught by Wobus to establish 
molecular profiles of different chemical compositions by treating a 
mammalian embryoid body with said chemical compositions because 
both Craig and Wobus teach testing the effect of a teratogenic agent 
on embryoid body by determining the resulting gene expression 
pattern and it was known in the art to determine the effect of a 



pa-9 12400 



'Application No.: 09/864,621 



8 



Docket No.: 441472000110 



chemical compound by detecting the alteration of gene expression or 
alteration of protein expression in an embryoid body because it was 
known in the art to determine the effect of a chemical compound by 
detecting the alteration of gene expression or alteration of protein 
expression." (Office Action, bridging paragraph, page 8-9). 

Applicant traverses this rejection for the reasons provided below. 

To establish a prima facie case of obviousness, the prior art reference(s) must teach or 
suggest all the claim limitations, there must be some suggestion or motivation to modify the 
reference or to combine reference teachings and their must be a reasonable expectation of success. 
M.P.E.P. § 2143. Both the suggestion and the reasonable expectation of success must be founded in 
the prior art, not in the Applicant's disclosure. See In re Vaeck , 20 USPQ2d 1438, 1442 (Fed. Cir. 
1991). Applicant respectfully submits that a prima facie case of obviousness has not been made by 
the Examiner. 

Spielmann relates to the use of embryonic stem cells in cytotoxicity screening assays. 
Cell death or inhibition of cell differentiation, was the endpoint used to assess cytotoxicity of the 
test chemicals in the Spielmann screening assays. Cell death or inhibition of cell differentiation, as 
endpoints, do not serve to identify the mechanism or biological pathway impacted by the test 
chemical as might a molecular profile. As noted by the Examiner, Spielmann does not teach or 
suggest creating molecular profiles of gene expression or protein expression. Therefore, Spielmann 
either alone or in combination cannot render the claimed invention obvious. 

Craig relates to the detection of expression of known developmentally-regulated genes 
in top minnow embryos exposed to a teratogen. Craig does not record alterations in genomic 
expression in a mammalian embryoid body contacted with a chemical and compiling a library of 
such molecular profiles. In fact, Craig teaches away from the use of a mammalian system by stating 
that her assay avoids "the inefficiencies inherent in the mammalian embryo system by 
circumventing the high cost and time commitments associated with traditional teratology studies" 
(page 123, left column, second full paragraph). In addition. Applicant notes that the methods of the 



pa-9 12400 



^Application No.: 09/864,621 



9 



Docket No.: 4414720001 10 



present invention works with expression of both known and unknown genes and does not require 
preselection of known developmentally-regulated genes. Accordingly, Craig does not remedy the 
deficiencies of Spielmann and cannot render the claimed invention obvious either alone or in 
combination. 

Wobus is cited for allegedly teaching protein expression. Wobus teaches detection of 
reporter gene expression driven by a known developmentally-regulated promoter and requires pre- 
selection of known developmentally regulated genes. Wobus does not teach or suggest recording 
alterations in genomic expression as required by the present claims. Further, Wobus requires 
preselection of known developmentally related genes, hi contrast, the methods used to produce the 
libraries of the present invention work with the expression of both known and unknown genes and 
does not require preselection of known developmentally regulated genes. Accordingly, like Craig, 
Wobus does not remedy the deficiencies of Spielmann. Therefore, Wobus cannot render the 
claimed invention obvious either alone or in combination. 

* Applicant further submits that the Examiner has not shown a suggestion or motivation to 
combine the Spielmann reference with the Wobus or Craig references, nor has the Examiner shown 
that there is a reasonable expectation of success. The Examiner merely states that "one of ordinary 
skill in the art would have been motivated to do so in order to generate a gene or protein expression 
profile" and that "according to the collective teachings of Spielmann, Craig and Wobus, with a 
reasonable expectation of success.'XOffice Action, page 9). Accordingly, Applicant respectfully 
submits that a prima facie case of obviousness has not been made and request withdrawal of this 
ground of rejection. 

Claim 1-1 1 are rejected under 35 U.S.C. 103(a) as being unpatentable over Serbedzija et 
al., 2001 (US Patent 6,299,858) in view of Spielmann et al, 1997 (In Vitro Toxicology, Vol. 10, 
No. 1, p. 1 19-127). Applicant traverses for the reasons provided herein below. 

Serbedzija relates to the use of a teleost embryo, specifically a zebra fish embryo, in a 
screening assay. In particular Serbedzija relates to methods of screening of an agent for 



pa-9 12400 



'Application No.: 09/864,621 



10 



Docket No.: 4414720001 10 



angiogenesis activity, toxic activity and an effect on cell death. Serbedzija does not specifically 
teach or suggest the recording alterations in genomic expression in mammalian embryoid bodies as 
required by the instant claims. In fact, Serbedzija teaches away from the use of a mammalian 
system (see col. 1 1, lines 65-67 and col. 12, lines 1-25). Spielmann does not remedy this deficiency 
for reasons argued herein above. Accordingly, withdrawal of this ground of rejection is respectfully 
requested. 



pa-9 12400 



* Application No.: 09/864,621 



11 



Docket No.: 4414720001 10 



CONCLUSION 



Applicants have, by way of amendments and remarks presented herein addressed all 



issues that were raised in the outstanding Office Action. Applicants respectfully contend that this 
Amendment has overcome the rejections and that the pending claims are in condition for allowance. 
If it is determined that a telephone conference would expedite the prosecution of this application, 
the Examiner is invited to telephone the undersigned at the number given below. 



other relief is required, apphcant petitions for any required relief including extensions of time and 
authorizes the Commissioner to charge the cost of such petitions and/or other fees due in connection 
with the filing of this document to Deposit Account No. 03-1952 referencing docket no. 
441472000110 . However, the Commissioner is not authorized to charge the cost of the issue fee to 
the Deposit Account. 

Dated: December 30, 2004 Respectfetty submitted, 



In the event the U.S. Patent and Trademark office determines that an extension and/or 




MORRISON & FOERSTER LLP 

755 Page Mill Road 

Palo Alto, Califomia 94304 

(650)813-5777 



pa-9 12400