Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. Election of group I with traverse is acknowledged. The traversal is based on prior art cited in the international search report does teach the special technical feature contributes to the unity of the invention and examining all groups together based on the unity of the invention. The arguments were found persuasive. The lack of unity is withdrawn herein and the claims 1-26 are considered for examination.
Status of the Application
2. Claims 1-26 are considered for examination.
Priority
3. This application filed on December 17, 2021 is a 371 of PCT/GB2020/050838 filed on March 27, 2020 which claims foreign priority benefit to GB1909325.1 filed on June 28, 2019.
Nucleotide and/or Amino Acid Sequence Disclosures
4. This application contains disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821.
(i) Nucleotide and/or amino acid sequences appearing in the specification (page 298, line 1-20, page 312, line 9-23) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
(ii) Nucleotide and/or amino acid sequences appearing in the drawings (Fig. 12, 18-20, 23-24, 31) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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 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 first and second barcoded oligonucleotides" in step (i) and (ii). There is insufficient antecedent basis for this limitation in the claim. The claim 17 upon which the claim 19 depends lack support for oligonucleotides. It is not clear if the barcoded oligonucleotides refer to barcode regions or do they refer to different barcode oligonucleotide sequences.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmermann et al. (US 2013/0123120) in view of Bodis et al. (US 2017/0002414).
Zimmermann et al. teach a method for claim 1-5, 10, comprising Preparing the sample for sequencing comprising linking at least two fragments of genomic DNA to produce a set of at least two linked (ligated) fragments of genomic DNA , wherein a barcode is appended to at least two genomic DNA fragments to produce a set of linked fragments of genomic DNA and sequencing each linked fragments in the set to produce at least two linked sequence reads wherein the sample comprises n cell-free DNA molecules (multiple (two or more) cell-free DNA ) (para 0604-0612, 0215-0228, 0597-0598, 0064-0068: indicating ligating adapters in a ligation based PCR amplification, wherein the primers comprise adapter sequences comprising barcode sequences, to produce linked genomic DNA fragments and sequencing the linked fragments).
With reference to claim 6,16, 20, 23, Zimmermann et al. teach that the method comprises partitioning the sample into at least two different reaction volumes (para 0063-0064, 0609).
With reference to claim 7, Zimmermann et al. teach preparing a sample for sequencing, comprising a cell-free microparticle wherein the cell-free microparticle comprises two fragments of genomic DNA, wherein the method comprises appending the at least two fragments of genomic DNA to a barcode sequence or to a different barcode sequence of a set of barcode sequences to produce a set of linked fragments of genomic DNA (para 0216-0228, 0597-0598, 0605-0612, 0064-0068).
With reference to claim 8,11, 14, Zimmermann et al. teach that prior to appending barcodes, appending a coupling sequence (linker sequence) to each of the two fragments of genomic DNA and appending barcodes to said coupling sequence (0216-0228, 0597-0598, 0605-0612, 0064-0068).
With reference to claim 9, 12, 15, Zimmermann et al. teach that the method comprises a first and second cell-free microparticle, appending a first barcode or different barcode to the first cell-free microparticle genomic fragments and appending a second barcode or a different barcode to the second cell-free microparticle genomic DNA fragments (0216-0228, 0597-0598, 0605-0612, 0620, 0064-0068).
With reference to claim 13, Zimmermann et al. teach appending each of the at least two fragments of genomic DNA of the cell-free microparticle to a different barcode sequence and sequencing each linked fragments in the set of linked fragments (para 0608).
With reference to claim 17-18, 21-22, teach contacting the sample with a library comprising at least two multimeric barcoding reagents, each multimeric barcoding reagents comprises a first and second barcode regions linked together, wherein each barcode region comprises a different barcode sequence; appending, annealing or ligating the barcode sequences to each of first and second fragments of the target nucleic acid of the first cell-free microparticle fragments of the genomic DNA; appending, annealing or ligating barcode sequences to each of the first and second fragments of the target nucleic acid of the second cell-free microparticle to produce first and second target nucleic acids sequences comprising first and second barcode sequences (para 0094-0098, 0048).
With reference to claim 19, teach that the appending step comprises annealing the first and second barcode sequences comprise barcoded oligonucleotides; extending the first and second barcoded oligonucleotides of the first multimeric barcoding reagents and the second multimeric barcoding reagents, wherein each of the barcoded target nucleotide molecules comprise a nucleotide synthesized from the fragments of genomic DNA as a template (para 0218-0223, 0240, 0034, 0048, 0067-0068).
However, Zimmermann et al. did not specifically teach a sample from preimplantation embryo generated by IVF.
Bodis et al. teach a method for preimplantation embryo genetic diagnosis by analyzing cell-free released by embryo into invitro culture medium, wherein the method comprises preparing a sample from the preimplantation embryo generated in IVF, and detecting genetic abnormalities in a nucleic acid amplification assay and sequencing read mapping, wherein the sample comprises extracellular micro vesicles, apoptotic bodies (fragmented DNA) or embryo culture medium (para 0018-0040, 0051-0075, 0089-0105).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention, to modify the method of Zimmermann et al. with a sample from preimplantation embryo generated by IVF as taught by Bodis et al. to develop an improved method for non-invasive prenatal detection of genetic abnormalities. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would result in improving the sensitivity of the method because Bodis et al. explicitly taught non-invasive prenatal diagnosis of embryos at risk for genetic defects or genetic aneuploids and determining the quality of the embryo before implanting in IVF assisted testing (abstract, para 0035, 0105) and such a modification of the method is considered to be obvious over the cited prior art.
Double Patenting
7. 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.
A. Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11, 268,131 (hereafter the ‘131) in view of Bodis et al. (US 2017/0002414).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims 1-26 are generic to claims 1-21 in the patent ‘131 or the claims 1-26 are obvious over the claims 1-21 of the patent ‘131. Specifically, the method of claims 1-26 comprising a sample comprising circulating microparticles, measuring linked signals corresponding to the presence or absence and/or level of at least two genomic DNA fragments are within the scope of the claims in the patent ‘131. The only obvious variation is that the claims in the patent ‘131 did not teach a sample from preimplantation embryo generated by IVF.
Bodis et al. teach a method for preimplantation embryo genetic diagnosis by analyzing cell-free released by embryo into invitro culture medium, wherein the method comprises preparing a sample from the preimplantation embryo generated in IVF, and detecting genetic abnormalities in a nucleic acid amplification assay and sequencing read mapping, wherein the sample comprises extracellular micro vesicles, apoptotic bodies (fragmented DNA) or embryo culture medium (para 0018-0040, 0051-0075, 0089-0105).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention, to modify the method of claims in the patent ‘131 with a sample from preimplantation embryo generated by IVF as taught by Bodis et al. to develop an improved method for non-invasive prenatal detection of genetic abnormalities. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would result in improving the sensitivity of the method because Bodis et al. explicitly taught non-invasive prenatal diagnosis of embryos at risk for genetic defects or genetic aneuploids and determining the quality of the embryo before implanting in IVF assisted testing (abstract, para 0035, 0105) and such a modification of the method is considered to be obvious over the cited prior art.
B. Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,287, 624 (hereafter the ‘624) in view of Bodis et al. (US 2017/0002414).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims 1-26 are generic to claims 1-27 in the patent ‘624 or the claims 1-26 are obvious over the claims 1-27 in the patent ‘624. Specifically, the method of claims 1-26 comprising a sample comprising circulating microparticles, measuring linked signals corresponding to the presence or absence and/or level of at least two genomic DNA fragments are within the scope of the claims in the patent ‘624. The only obvious variation is that the claims in the patent ‘624 did not teach a sample from preimplantation embryo generated by IVF.
Bodis et al. teach a method for preimplantation embryo genetic diagnosis by analyzing cell-free released by embryo into invitro culture medium, wherein the method comprises preparing a sample from the preimplantation embryo generated in IVF, and detecting genetic abnormalities in a nucleic acid amplification assay and sequencing read mapping, wherein the sample comprises extracellular micro vesicles, apoptotic bodies (fragmented DNA) or embryo culture medium (para 0018-0040, 0051-0075, 0089-0105).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention, to modify the method of the claims in the patent ‘624 with a sample from preimplantation embryo generated by IVF as taught by Bodis et al. to develop an improved method for non-invasive prenatal detection of genetic abnormalities. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would result in improving the sensitivity of the method because Bodis et al. explicitly taught non-invasive prenatal diagnosis of embryos at risk for genetic defects or genetic aneuploids and determining the quality of the embryo before implanting in IVF assisted testing (abstract, para 0035, 0105) and such a modification of the method is considered to be obvious over the cited prior art.
C. Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. US 17/254,153 (hereafter the ‘153) in view of Bodis et al. (US 2017/0002414).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1-26 are generic to claims 1-20 in the co-pending application ‘153 or the claims 1-26 are obvious over the claims 1-20 in the co-pending application ‘153. Specifically, the method of claims 1-26 comprising a sample comprising circulating microparticles measuring a linked signals corresponding to the presence or absence and/or level of at least two genomic DNA fragments are within the scope of the claims in the co-pending application ‘153. The only obvious variation is that the claims in the co-pending application ‘153 did not teach a sample from preimplantation embryo generated by IVF.
Bodis et al. teach a method for preimplantation embryo genetic diagnosis by analyzing cell-free released by embryo into invitro culture medium, wherein the method comprises preparing a sample from the preimplantation embryo generated in IVF, and detecting genetic abnormalities in a nucleic acid amplification assay and sequencing read mapping, wherein the sample comprises extracellular micro vesicles, apoptotic bodies (fragmented DNA) or embryo culture medium (para 0018-0040, 0051-0075, 0089-0105).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention, to modify the method of claims in the co-pending application ‘153 with a sample from preimplantation embryo generated by IVF as taught by Bodis et al. to develop an improved method for non-invasive prenatal detection of genetic abnormalities. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would result in improving the sensitivity of the method because Bodis et al. explicitly taught non-invasive prenatal diagnosis of embryos at risk for genetic defects or genetic aneuploids and determining the quality of the embryo before implanting in IVF assisted testing (abstract, para 0035, 0105) and such a modification of the method is considered to be obvious over the cited prior art. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681