DETAILED ACTION
Status of the Claims
Claims 53 and 64 are amended.
Claims 53-74 are pending and examined herein.
The following Office Action is in response to Applicant's communication dated 06/03/2026. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. Specifically, the objection to the disclosure for minor informalities is withdrawn in light of Applicant's amended specification. The following rejections(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application is being examined under the pre-AIA first to invent provisions.
Modified Claim Rejections - 35 USC § 103
Necessitated by Amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 53-74 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. ((CSH Symp Quant Biol 2003, 68: 69-78; of record) in view of Paterlini-Brechot et al. (PGPub No: US2005/0049793; of record) and Dhallan et al. (PGPub No: US2004/0137470; cited in IDS of 4/5/24).
Regarding claims 53 and 64, Fan teaches a method comprising: hybridizing probes to single nucleotide polymorphism (SNP) sites (p. 70, col. 2); ligating the hybridized probes to each other to create an amplification template (Fig. 2; p. 70, col. 2); amplifying the amplification template to create amplification products (Fig. 2; p. 70, col. 2); hybridizing the amplification products to probes on a microarray (Fig. 2; p. 70, col. 2); and detecting signal intensities of the amplification products hybridized to probes on the microarray (p. 70, col. 2).
However, Fan does not disclose enriching a maternal blood sample for fetal genomic DNA (gDNA) or cells to produce an enriched sample. Fan also does not explicitly disclose the SNP sites being on two chromosomes and including a test region specifically selected from the group consisting of chromosomes 13, 18, 21, X, and Y and a control region of a second chromosome that is different from the first chromosome.
Paterlini-Brechot teaches enriching a maternal blood sample for fetal cells (p. 2, ¶ [0020]), which would thereby also enrich the sample for fetal gDNA. Additionally, Paterlini-Brechot teaches lysing the cells in the enriched sample to obtain gDNA (p. 5, ¶ [0067]) and that probes are hybridized to the Y chromosome (p. 8, ¶ [0122]).
Furthermore, Fan discloses that the “GoldenGate” assay method is preferable to those that utilize conventional PCR – as described in Paterlini-Brechot – because it requires “only three universal primers for PCR” and eliminates “primer sequence-related differences in amplification rates between SNPs” (Fan: p. 70, col. 2). Therefore, one of ordinary skill in the art would have been aware that applying the assay method of Fan to the prenatal diagnostics of Paterlini-Brechot would result in a more efficient and larger scale screen for fetal genetic abnormalities.
In combining these methods, one of ordinary skill in the art would have a reasonable expectation of success because SNP genotyping by probe ligation had been previously used to diagnose fetal genetic abnormalities, as exemplified in Hochstenbach. This publication discloses the use of multiplex ligation-dependent probe amplification (MPLA) to detect fetal aneuploidy in chromosomes 13, 18, 21, X and Y (p. 1032, Introduction). The fact that this method was able to successfully detect relative amounts of SNPs present in fetal gDNA would have indicated that the similar method of Fan would have been successful at accomplishing prenatal diagnostics of Paterlini-Brechot.
Therefore, it would have been obvious to one of ordinary skill in the art by the effective filing date of the invention to apply the method of Fan to the prenatal diagnostic method of Paterlini-Brechot based on the motivation in Fan with a reasonable expectation of success.
Additionally, Dhallan discloses detecting loci on two different chromosomes (p. 37, ¶[0384]), wherein the loci comprise SNP sites in a test region of chromosome 13, 18, or 21 (p. 37, ¶[0384]) and a control region of a second chromosome that is different from the first chromosome (p. 35, ¶[0368-70]; p. 37, ¶[0386]; p. 132, ¶[2387-2390]). Dhallan also teaches that detecting these loci can be accomplished by a variety of methods, including amplification (PCR), hybridization, and BeadArray Technology (p. 3, ¶[0042-3]), which are described in Fan.
One of ordinary skill in the art would also have motivation to apply the method of Dhallan to that of Fan and Paterlini-Brechot as Fan teaches that the GoldenGate method reduces costs and increases productivity of SNP genotyping studies (p. 69, col. 1, 2nd ¶). Additionally, there would have been a reasonable expectation of success as the disclosure of Fan indicates that “any SNPs of interest” can be assayed by the disclosed method (p. 70, col. 2), and the method of Dhallan is compatible with gDNA obtained from maternal blood samples (p. 17, ¶[0175]; p. 130, ¶[2346-8]).
Therefore, it would have been obvious to one of ordinary skill in the art by the effective filing date to combine the loci disclosed by Dhallan with the method disclosed by Fan and Paterlini-Brechot based on the motivation in Fan with a reasonable expectation of success.
Regarding claims 54 and 65, Paterlini-Brechot discloses that the maternal blood sample is from a pregnant woman within a first or second trimester (p. 3, ¶ [0035]).
Regarding claims 55-58 and 66-69, Fan teaches attaching the gDNA to a solid support (p. 70, col. 2) that comprises a paramagnetic particle and streptavidin (streptavidin-coated magnetic beads: p. 77, col. 1) and that the gDNA is biotin-labeled (p. 77, col. 1).
Regarding claims 59 and 70, Fan discloses that three oligonucleotide probes are provided for each locus (two allele-specific oligonucleotides and one locus-specific oligonucleotide: p. 70, col. 2).
Regarding claims 60-61 and 71-72, Fan discloses that the ligation occurs while the gDNA is attached to a particle (Fig. 2; p. 70, col. 2) and releasing the amplification template from the gDNA attached to the particle (Fig. 2; p. 77, col. 1: “heated… to release the ligated products”).
Regarding claims 62 and 73, Fan discloses that the amplification template comprises universal PCR primer sites (Fig. 2: P1/P2; p. 70, col. 2) and that the amplification comprises hybridization of universal primers to the universal PCR primer sites (Fig. 2: P1/P2; p. 77, col. 1).
Regarding claims 63 and 74, Fan further discloses that the microarray is a DNA microarray (p. 69, col. 1: “random arrays of DNA-coated beads”).
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Response to Arguments
The 06/03/2026 remarks argue that not all limitations are taught and that one of ordinary skill would not combine the methods of Fan and Paterlini-Brechot. Applicant's arguments have been fully considered but they are not persuasive.
Specifically, applicant argues that “one of skill in this field would not have combined Fan, a highly multiplexed genotyping assay for analyzing a very large number of cells at once, and Paterlini-Brechot, which is a single cell assay.” In support of this characterization, Applicant cites ¶s [0018] and [0022] of Paterlini-Brechot. However, Paterlini-Brechot also discloses this enrichment method can be used for bulk cell assays (p. 4, ¶[0044]), including those for detecting chromosomal abnormalities (p. 4, ¶[0051]). As such, Applicant’s argument is not considered persuasive.
It is believed that the remaining arguments have been sufficiently addressed by the modified rejections.
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.
US 10,704,090 B2
Claims 53-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10704090. Although the claims at issue are not identical, they are not patentably distinct from each other because they claim identical subject matter with the exception of the ‘090 patent failing to disclose enriching a maternal blood sample for fetal cells (gDNA is disclosed) and that the plurality of loci comprise SNP sites. However, this would have been obvious to one of ordinary skill in the art by the effective filing date of the invention because of the disclosures previously discussed in Paterlini-Brechot and Fan, respectively, as well as the information contained within the disclosure of the ‘090 patent.
Additionally, the ‘090 patent does not specifically state that the first chromosome is selected from the group consisting of chromosomes 13, 18, 21, X, and Y. However, it does disclose “a first chromosome suspected of being aneuploid” (claim 1f). As the vast majority of human aneuploidies occur within chromosomes 13, 18, 21, X and Y (Hassold et al. Environ Mol Mutagen, 1996, 28(3): 167-75), the disclosure from the reference patent anticipates the list enumerated in the instant application.
US 11,674,176 B2
Claims 53-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11674176. Although the claims at issue are not identical, they are not patentably distinct from each other because they claim identical subject matter with the exception of the ‘176 patent failing to disclose that the plurality of loci comprise SNP sites. This would have been obvious as per the discussion above. Similarly, the disclosure of “a first chromosome suspected of being aneuploid” anticipates the specific disclosure of chromosomes 13, 18, 21, X and Y as previously discussed.
Response to Arguments
The 06/03/2026 reply includes Applicant’s response to the nonstatutory double patenting rejection of record: “Applicant requests that the Office hold these rejections in abeyance until all other rejections of the present claims have been overcome.”
This request is not the filing of a terminal disclaimer, or filing of a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, as the required response in accordance with MPEP 804 I.B.1. Applicant’s request is expressly contrary to MPEP 804 I.B.1. (see also MPEP 714.03 and 37 C.F.R. 1.111).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Alexandra Olson whose telephone number is (571)272-7519. The examiner can normally be reached Monday-Friday 9-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at (571) 272-2878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA OLSON/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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