Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. The Applicant’s response to the office action filed on July 20, 2026 is acknowledged.
Status of the Application
2. Claims 2-15 are pending under examination. Claim 1 is canceled. The Applicant’s arguments have been fully considered and found persuasive in-part for the following reasons.
Claim Rejections - 35 USC § 103-Maintained
3. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue.3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
over Fan et al. (US 2010/0138165) in view of Pinter et al. (US 2004/0209299).
Fan et al. teach a method 2-7, 11-14, for detecting chromosomal aneuploidy in human
patient samples including maternal plasma sample by mapping human chromosome
changes using sequence tags wherein the method comprises sequencing each of the
amplicons in the plurality of amplicons comprising repetitive elements, aligning in silico
the sequenced amplicons from each of said 22 autosome patient chromosomes to
reference set of all 22 autosome human non-aneuploid chromosomes in order to
produce a query distribution for each of said 22 autosome patient chromosomes,
mapping number of tags within each 5 bp window and mapping chromosomal changes
which include chromosome 12, 13, and 18 and detecting aneuploidy in human
chromosomes including gain or loss of chromosomes or chromosome regions
compared to reference set of human chromosomes, wherein plurality of amplicons is
less than 180 bp (para 0021-0033, 0083-0092, 0049-0053, 0070-0074, 0119).
With reference to claims 8-9, 15, Fan et al. teach that the sample comprises blood
sample including maternal sample the average length of plurality of amplicons is less
than 250 bp or less than 150 bp or with a median length of 177-180 bp and comprises
10 million copies or amplicons of its initial DNA fragment (para 0021-0033, 0049-0053,
0083-0084).
With reference to claim 10, Fan et al. teach unique sequence tags attached to 5’ end of
primers (para 0086).
However, Fan et al. did not teach use of a single primer pair that anneals to a
plurality of repeat genomic regions.
Pinter et al. teach a whole genome amplification suing a single primer pair that
anneals to short repeat sequences (Alu specific primer pair) and determining STR
marker distribution in amplified DNA from plasma or serum samples (para 0362-0373).
It would have been prima facie obvious to one skilled in the art at the time the
invention was made to modify the method as taught by Fan et al. with a single primer
pair as taught by Pinter et al. to develop an improved sensitive method for detecting
sequence variation in chromosomes in a nucleic acid sample. The ordinary person
skilled in the art would have been motivated to combine the references and have a
reasonable expectation of success that the combination would result in an improved
method for detecting chromosomal aneuploidy because Pinter et al. explicitly taught
whole genome amplification using a single primer pair which provides a distribution of
whole genome short repeat sequences and detection of genome variation in said repeat
sequences (para 0372-0373) and such a modification of the method is considered
obvious over the cited prior art.
Response to Arguments:
With reference to the rejection of claims 2-15 under 35 USC 103 as being obvious over Fan et al. in view of Pinter, the Applicant’s arguments have been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to no teaching of whole genome amplification using a single primer pair by Pinter, the arguments were found unpersuasive. First, the claims as presented require amplifying at least a portion of the nucleic acid using a single primer pair which does not require whole genome amplification. Second, the single primer pair of Pinter et al. (para 0369) anneals to the repeat genomic regions as claimed and said primer pair is used for whole genome amplification. With reference to the Applicant’s arguments drawn to Pinter teaching two different amplification steps, the arguments have been found unpersuasive because the claims are in open ‘comprising’ format and any additional steps are within the scope of the claims as noted in MPEP 2111.03. Thus, adding adaptors and amplifying the genomic DNA by a single Alu primer pair is within the scope of the claims as presented. With reference to the size of the amplicons taught by Pinter et al., the arguments have been found unpersuasive because the Applicant’s arguments are drawn to amplicons generated by using universal primers, as opposed to amplicons generated by Alu primer pair. In addition, Fan et al. teach amplicons of less than 180 bp and the combination of the references teach said limitation. With reference to no suggestion to combine the method of Fan et al. with a single Alu primer pair as taught by Pinter et al., the arguments were found unpersuasive because as discussed in the rejection Fan et al. teach a method for detecting aneuploidy in a nucleic acid sample and it would be obvious to modify the method of Fan et al. with a single primer pair as taught by Pinter to detect genetic variation. For all the above, the rejection has been maintained and restated.
Double Patenting-Withdrawn
4. The rejection of claims under obviousness type of double patenting over the claims in US 12,116,628 has been withdrawn in view of terminal disclaimer.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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