DNAprint Genomics (DNAG)

[worktoplay]

kermy...I take it this is the invite to provide the information. So be it.

The following is taken from DNAPrint's 55 page response to the patent Examiner reviewing the Statin Classifier patent. These arguments are being made by Ms. Lisa Haile, PhD, JD on behalf of DNAPrint:

http://portal.uspto.gov/external/portal/!ut/p/_s.7_0_A/7_0_CH/.cmd/ad/.ar/sa.getBib/.c/6_0_69/.ce/7_...

Those genes, including HMGCR and CYP3A4, were selected for the investigations that lead to the invention, and were analyzed for the presence of all SNP's, whether related to Statin response or not. Specification at 110, [0278]. Specifically, the identified genes from DNA samples of a population of 500 unrelated, multi-ethnic donors were scored, resulting in the identification of 25 SNP's in the HMGCR gene and 23 SNP's in the CYP3A4 gene. Id. At 133, [0328]. The specification teaches that none of the SNP's identified thereby were previously known in the literature or reported in the NCBI dbSNP Database. Id.

This from page49:

The present Specification teaches that "[t]he public genome database was constructed from a relatively small collection of donors", and thus, the relevant SNP's may be under-represented or biased against in the public human SNP and Unigene Databases." Specification at p. 110, [0278]. Considering these facts, Applicant completely resequenced the CYP3A4 and HMGCR genes in a large, multi-ethnic population (n=500). Id. at 133, [0328]. Notably, none of the SNP's of the present invention had previously been reported. Id.

It continues later on the page:

Finally, Applicants submit that post-filing art not sited by the Examiner supports and confirms the correlation to a number of the claimed SNP's. See, for Example, variations catalogued in GeneBank Accession No.: AY321356 (Exhibit F).

I rest my case...

Later,
W2P