DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See para [00106], page 24, line 2 of specification filed 4/24/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the computer executable logic" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation "the ultra-deep sequencing" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,781,187. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘187 claims disclose:
Regarding claim 2:
A method for determining a presence or absence of a fetal aneuploidy of a fetus in a maternal blood sample from a woman who is pregnant or who is suspected of being pregnant,
‘187 claim 1: “A method for determining a presence or absence of a fetal aneuploidy of a fetus in a maternal blood sample from a woman who is pregnant or who is suspected of being pregnant…”.
the method comprising: (a) obtaining a mixture of fetal and maternal cells from the maternal blood sample and dividing the mixture into discrete locations such that no more than one cell is located per discrete location;
‘187 claim 1: “…the method comprising: (a) obtaining a mixture of fetal and maternal cells from the maternal blood sample and dividing the mixture into discrete locations such that no more than one cell is located per discrete location…”.
(b) obtaining genomic DNA from fetal cells or maternal cells located within the discrete locations;
‘187 claim 1: “…(b) obtaining genomic DNA from fetal cells or maternal cells located within the discrete locations…”.
(c) conducting multiplex polymerase chain reaction (PCR) to amplify target regions in the genomic DNA to obtain amplified nucleic acid molecules, wherein each amplified nucleic acid molecule comprises a tag that identifies the nucleic acid molecule as coming from a specific discrete location;
‘187 claim 1: “…(c) conducting multiplex polymerase chain reaction (PCR) to amplify target regions in the genomic DNA to obtain amplified nucleic acid molecules, wherein each amplified nucleic acid molecule comprises a tag that identifies the nucleic acid molecule as coming from a specific discrete location…”.
(d) pooling the amplified nucleic acid molecules with tagged amplicons from at least one other multiplex PCR;
‘187 claim 1: “…(d) pooling the amplified nucleic acid molecules with tagged amplicons from at least one other multiplex PCR…”.
(e) conducting quantitative genotyping to quantify DNA regions of at least one chromosome being tested for aneuploidy and of at least one control chromosome that is presumed to be diploid;
‘187 claim 1: “…(e) conducting ultra-deep sequencing of the pooled amplified nucleic acid molecules obtained in step (d) to produce sequence data representing a partial genome for analysis of allele abundance, wherein the ultra-deep sequencing comprises further amplification of the amplified nucleic acid molecules to produce at least one million copies of individual amplified nucleic acid molecules in parallel; (f) using the sequence data of step (e) to quantify DNA regions of at least one chromosome being tested for aneuploidy and of at least one control chromosome that is presumed to be diploid…”. The steps recited in (e)-(f) of ‘187 claim 1 is a form of quantitative genotyping (analysis of allele abundance).
and (f) determining the presence or absence of a fetal aneuploidy for the at least one chromosome being tested for aneuploidy from quantification of the chromosomal DNA regions of step (e).
‘187 claim 1: “…(g) determining the presence or absence of a fetal aneuploidy for the at least one chromosome being tested for aneuploidy from quantification of the chromosomal DNA regions of step (f).”
Regarding claim 16:
wherein the quantitative genotyping comprises ultra-deep sequencing, wherein the ultra-deep sequencing comprises further amplification of the amplified nucleic acid molecules to produce at least one million copies of individual amplified nucleic acid molecules in parallel
‘187 claim 1: “…(e) conducting ultra-deep sequencing of the pooled amplified nucleic acid molecules obtained in step (d) to produce sequence data representing a partial genome for analysis of allele abundance, wherein the ultra-deep sequencing comprises further amplification of the amplified nucleic acid molecules to produce at least one million copies of individual amplified nucleic acid molecules in parallel…”.
Regarding claims 3-15, these correspond exactly to ‘187 claims 2-14, respectively.
Regarding claims 17-19, these correspond exactly to ‘187 claims 16-18, respectively.
Therefore, the instant claims are anticipated by the narrower ‘187 claims, rendering the instant claims obvious.
Conclusion
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681