Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
OBJECTION
2. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Analysis of nucleic acids associated with extracellular vesicles in pregnant females.
NON-PRIOR ART REJECTION
3. 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.
Claims 1 and 22 are 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.
A) Claim 1 is indefinite because ‘the extracellular particle’ in line 4 lacks proper antecedent basis; line 3 recites ‘extracellular particles.’ Correction is required.
B) Claim 22 is indefinite because of improper Markush language. In the recited format, ‘the group’ is required in line 2, as opposed to ‘a group’. Correction is required.
PRIOR ART REJECTION
4. 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.
5. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 10-13, 17, 19-26, and 28-46 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 11,242,520).
Regarding independent claim 1, Gao discloses a method comprising: receiving a blood sample of a female having a pregnancy with a fetus, enriching for extracellular particles, disrupting said particles to expose cell-free nucleic acid molecules, and assaying said molecules to obtain sequence reads.
Regarding independent claim 10, Gao discloses a method comprising: receiving a blood sample of a female having a pregnancy with a fetus, performing a physical separation that selects at least a portion of extracellular particles to obtain a particle-enriched sample, disrupting said particles to expose cell-free nucleic acid molecules, and assaying said molecules to obtain sequence reads.
Regarding independent claim 13, Gao discloses a method comprising: receiving a blood sample of a female having a pregnancy with a fetus, enriching for extracellular particles to produce an enriched sample, disrupting said particles to expose cell-free nucleic acid molecules, sequencing said molecules to obtain sequence reads, and analyzing said sequence reads.
Regarding claims 1, 10, and 13, see columns 1-14.
Regarding claim 1, Gao does not disclose determining sizes of cell-free nucleic acids, identifying a set of such nucleic acids being 200 bp or more in size, and analyzing sequence reads of said set.
Regarding claim 10, Gao does not disclose treating said sample to remove excess particle-free nucleic acids, said treatment comprising washing and applying a nuclease to increase the fractional concentration of fetal nucleic acids.
Regarding claim 13, Gao does not disclose at least a portion of sequence reads being more than 600 bp in length.
One of ordinary skill in the art would have been motivated to modify the method of Gao in the manner of these claims because doing so would have merely involved routine optimization of known-important reaction parameters, which as well settled in U.S. patent practice does not support unobviousness (M.P.E.P. 2144.05). Regarding claim 1, the skilled artisan would have optimized the length of cell-free nucleic acids in order to optimize sequencing information and efficiency. Regarding claim 10, the skilled artisan would have optimized fractional concentration of fetal nucleic acids by eliminating excess maternal nucleic acids using conventional washing and nuclease-treating steps. Regarding claim 13, the skilled artisan would have optimized the length of sequence reads in order to optimize sequencing information and efficiency. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed methods.
Regarding claim 11, Gao discloses sequencing (column 7, lines 64-67).
Regarding claim 12, PBS was a conventional wash solution in cell/nucleic acid analysis.
Regarding claim 17, it would have merely involved straightforward, logical scientific reasoning to detect genomic characteristics relating to pregnancy complications, as this was clearly important information.
Regarding claims 19-22, these merely relate to routine optimization of washing and nuclease-treating steps using conventional wash solutions and nucleases.
Regarding claims 23-25, these merely relate to routine optimization of physical separation using conventional separation techniques.
Regarding claims 26 and 28, these merely involve optimizing size selection of extracellular particles using conventional means.
Regarding claims 29-33, these merely involve optimizing genetic and sequencing analysis using conventional techniques.
Regarding claim 34, this merely relates to conventional membrane disruption or lysing means.
Regarding claim 35, this merely relates to optimizing sequencing information.
Regarding claims 36-46, these merely involve conventional sequencing techniques and genomic analysis.
CONCLUSION
6. No claims are free of the prior art.
7. Edelman (US 2021/0254136) and Mcelrath et al. (US 2024/0339220) are made of record by the Office as references of interest.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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01/28/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681