Case 1:20-cv-01644-RGA Document 1-21 Filed 12/03/20 Page 1 of 4 PageID #: 904
`Case 1:20-cv-01644-RGA Document 1-21 Filed 12/03/20 Page 1 of 4 PageID #: 904
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`EXHIBIT 21
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`EXHIBIT 21
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`Case 1:20-cv-01644-RGA Document 1-21 Filed 12/03/20 Page 2 of 4 PageID #: 905
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`I hereby certify that this paper is being deposited with the U.S. Postal Service as
`Express Mail, Airbill No. EV 377984043 US, on the date shown below in an
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`envelope addressed to: MS Amendment, CommisV2ion for Pa~x·, Box
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`1450, Alexandria, VA 22313-145?. /)
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`•
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`ated: May 30, 2007 Signature:~1}1tl.u
`( Rosemarie Puljic-
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`•. ·-
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`eron }
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`Docket No.: 543312000420
`(PATENT)
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Patent Application of:
`Ravinder S. DHALLAN
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`Confirmation No.: 7501
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`Application No.:
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`10/661,165
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`Art Unit:
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`1634
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`Filed:
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`For:
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`September 11, 2003
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`Examiner:
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`E. Whisenant
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`METHODS FOR DETECTION OF
`GENETIC DISORDERS
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`AMENDMENT IN RESPONSE TO NON-FINAL OFFICE ACTION
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`MS Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Dear Sir:
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`INTRODUCTORY COMMENTS
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`This is in response to the non-final Office Action dated January 30, 2007 (Part of Paper
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`No./Mail Date 20070105), for which a response was due on April 30, 2007. Filed herewith is a
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`Petition and fee for a one month extension of time, thereby extending the deadline for response to
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`May 30, 2007. Accordingly, this response is timely filed. Reconsideration and allowance of the
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`pending claims, as amended, in light of the remarks presented herein are respectfully requested.
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`Amendments to the Claims are reflected in the listing of claims which begins on page 2
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`of this paper.
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`Remarks/Arguments begin on page 24 of this paper.
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`pa-1169673
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`Case 1:20-cv-01644-RGA Document 1-21 Filed 12/03/20 Page 3 of 4 PageID #: 906
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`Application No.: 10/661, 165
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`30
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`Docket No.: 543312000420
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`comprise calculating a ratio of the relative amount of alleles in a heterogeneous mixture of DNA,
`i.e, maternal DNA and fetal DNA. The methods taught in the present invention comprise
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`determining a ratio, wherein the ratio represents alleles from both the mother and the fetus.
`Umansky et al. and Saiki et al. fail to teach or suggest this element, either alone or in combination.
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`Applicants have invented a method for detecting the presence or absence of a fetal
`chromosomal abnormality, wherein the method comprises, inter alia, quantitating a ratio of the
`relative amount of alleles in a mixture of maternal DNA and fetal DNA. One such example, which
`is not to be construed as limiting the invention in any manner, can be found in Example 14 of the
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`specification. As discussed in paragraphs [1018] through [1021], ratios were calculated at both
`chromosomes 13 and 21 in a heterogeneous mixture of75% Down syndrome DNA and 25%
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`maternal DNA. Single nucleotide polymorphisms were analyzed wherein the maternal genome was
`homozygous for one allele at a specific genetic site and the Down syndrome DNA was
`heterozygous at the same genetic site. If at a certain site, the maternal genome contains an adenine
`at both copies of chromosome 13, and the Down syndrome genome is comprised of one
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`chromosome with an adenine nucleotide and one chromosome with a guanine nucleotide, then the
`ratio of G:A is 0.60 (0.75 (Down syndrome G allele)/(0.75 Down syndrome A allele+ 0.25 + 0.25
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`(maternal A alleles).
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`On the other hand, if at a certain genetic site on chromosome 21, the maternal genome
`contains an adenine at both copies of chromosome 21, and the Down syndrome genome is
`comprised of two chromosome with an adenine nucleotide and one chromosome with a guanine
`nucleotide, then the ratio of G:A is 0.375 (0.75 (Down syndrome G allele)/(0.75 Down syndrome A
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`allele+ 0.75 Down syndrome A allele+ 0.25 + 0.25 (maternal A alleles). Thus, the methods
`described in the present application detect chromosomal abnormalities using a method that
`comprises, inter alia, quantitating a ratio of alleles in a heterogeneous mixture of DNA, wherein the
`ratio represents alleles from more than one individual. This element is neither taught nor suggested
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`by Umnasky et al., either alone or in combination with Saiki et al.
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`pa-1169673
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`Case 1:20-cv-01644-RGA Document 1-21 Filed 12/03/20 Page 4 of 4 PageID #: 907
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`Application No.: 10/661,165
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`67
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`Docket No.: 543312000420
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`CONCLUSION
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`In view of the above, each of the presently pending claims in this application is believed
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`to be in immediate condition for allowance. Accordingly, the Examiner is respectfully requested to
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`withdraw the outstanding rejection of the claims and to pass this application to issue. If it is
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`determined that a telephone conference would expedite the prosecution of this application, the
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`Examiner is invited to telephone the undersigned at the number given below.
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`In the event the U.S. Patent and Trademark office determines that an extension and/or
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`other relief is required, applicant petitions for any required relief including extensions of time and
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`authorizes the Commissioner to charge the cost of such petitions and/or other fees due in connection
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`with the filing of this document to Deposit Account No. 03-1952 referencing docket no.
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`543312000420. However, the Commissioner is not authorized to charge the cost of the issue fee to
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`:~
`i:::::o.::4
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`Alicia J. Ha
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`MORRISON & FOERSTER LLP
`755 Page Mill Road
`Palo Alto, California 94304-1018
`(650) 813-4296
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`the Deposit Account.
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`Dated: May 30, 2007
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`pa-1169673
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