DETAILED ACTION
Status of the Claims
Claims 53-74 are currently pending and examined herein
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 of the following informalities: on page 28, ¶s [00146] and [00147] refer to Figures 8A and 8B, which should be 9A and 9B, respectively.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
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 pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fan et al. (CSH Symp Quant Biol 2003, 68: 69-78, cited in IDS of 4/5/24) in view of Paterlini-Brechot (PGPub No: US 2005/0049793 A1, cited in IDS of 4/5/24) and Hochstenback et al. (Prenat Diagn 2005, 25: 1032-1039).
Regarding claims 53 and 64, Fan teaches a method comprising: hybridizing probes to single nucleotide polymorphism (SNP) sites on least two chromosomes (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 disclose the SNP sites being on chromosomes specifically selected from the group consisting of chromosomes 13, 18, 21, X, and Y.
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 could 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.
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”).
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.
Conclusion
No claims are allowed.
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/ALEXANDRA OLSON/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684