DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on October 24, 2025 has been entered. The claims pending in this application are claims 1, 2, 6, 9-11, and 13-15. The rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on October 7, 2024. Claims 1, 2, 6, 9-11, and 13-15 will be examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11, and 13-15 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Ohashi et al., (WO 2015/001629, published on January 8, 2015, wherein US Patent No. 10,159,909 B2 is used as a translation of WO 2015/001629).
Regarding claims 1, 11, and 13-15, since the word “pre-synthesized” is read as “[S]ynthesized in advance” (see “Presynthesized Definition”), there is no definition for “Presynthesized” in the specification, cell lysate 141 in the cell lysate layer of Figure 4 taught by Ohashi et al., is obtained from human stored blood, cell lysate 141 must include different single stranded DNAs which are not complementary from each other and pre-synthesized in the cells of the human stored blood. Thus, Ohashi et al., teach a base sequence analysis pretreatment method, comprising: preparing a pretreatment kit comprising an elongated container (ie., device 150) having a longitudinal direction, the container having an opening at one end that is configured to be closable, the container includes therein, sequentially stacked along the longitudinal direction from the opening: a lavage fluid layer (ie., the second washing liquid layer 132) for removing a contaminant attached to a first magnetic particle and/or a second magnetic particle, a medium layer (ie., third gelled medium 123) being insoluble or hardly soluble in water, and a recovery liquid layer (ie., the eluting liquid layer 133), in this order, the container including therein, 1) a sample from a subject, the sample including a first nucleic acid to be analyzed (ie., one DNA from a cell lysate 141), and a contaminant, 2) a pre-synthesized second nucleic acid for individual identification (ie., another different DNA from a cell lysate 141 from pre-synthesized DNAs in the cells of human stored blood), the second nucleic acid having a base sequence noncomplementary to the first nucleic acid, 3) magnetic particles including the first magnetic particle to which the first nucleic acid is attached and the second magnetic particle to which the second nucleic acid is attached, applying magnetic force from outside of the container to move the magnetic particles together with the first and second nucleic acids from the lavage fluid layer through the medium layer to the recovery liquid layer; and recovering the first and second nucleic acids in the recovery liquid layer (ie., by eluting different DNAs from magnetic beads) for base sequence analysis of the recovered first and second nucleic acids as recited in claim 1 wherein the medium layer is a gel layer as recited in claim 11, the recovery layer is a nucleic acid eluate for eluting a nucleic acid attached to a surface of the magnetic particles from the surface of the particles as recited in claim 13, the container is configured to be separable in a vicinity of a portion of the container (ie., capable of incising with a cutter knife) where the recovery liquid layer is contained as recited in claim 14, and the second nucleic acid further contains a base sequence complementary to a nucleic acid (eg., a complementary strand of the second nucleic acid) contained in the biological sample on at least one of 3’-side and 5’-side of the base sequence noncomplementary to the first nucleic acid as recited in claim 15 (see Figure 4 and columns 18-20 of US Patent No. 10,159,909 B2).
Therefore, Ohashi et al., teach all limitations recited in claims 1, 11, and 13-15.
Response to Arguments
In page 6, second paragraph bridging to page 9, first paragraph of applicant’s remarks, applicant argues that “[T]he Applicant asserts that the pending Claim 1, as amended, is novel over the disclosure in Ohashi et al., specifically due to the mandatory presence of a ‘pre-synthesized second nucleic acid’ feature, which is entirely absent from the cited prior art. The Examiner asserts that the nucleic acid extraction method described in Ohashi et al. (using human stored blood/cell lysate 141) anticipates Claim 1. This assertion relies on the interpretation that different, naturally occurring single-stranded DNAs (SS-DNAs) within the cell lysate satisfy the definitions of the claimed ‘first nucleic acid to be analyzed’ and the ‘pre- synthesized second nucleic acid’. Applicant respectfully traverses this rejection. While the Examiner applies the broadest reasonable interpretation (BRI) consistent with the specification, the addition of the term "pre- synthesized" imposes a critical structural and functional limitation that Ohashi et al. fundamentally fails to disclose or suggest, either explicitly or inherently. Claim 1 requires the presence of a second nucleic acid defined by two essential characteristics: 1. It must be pre-synthesized. 2. It must possess a base sequence noncomplementary to the first nucleic acid (the
analysis target). Ohashi et al. is directed to a particle manipulation method, exemplified by the extraction of genomic DNA from human whole blood using magnetic beads. The reference describes purifying naturally occurring nucleic acids (genomic DNA) derived directly from the biological sample (cell lysate 141). The Examiner suggests that the differing naturally occurring DNAs present in the biological sample fulfill the requirements of the second nucleic acid. However, this argument fails for the following reasons: The term ‘pre-synthesized’ explicitly dictates that the second nucleic acid must be manufactured by human agency (e.g., chemical synthesis prior to its introduction into the kit/sample), in contrast to naturally occurring biological material. •The nucleic acids recovered in Ohashi et al. originate exclusively from the human stored blood (biological sample/cell lysate 141). These are naturally occurring genomic or cellular fragments, not deliberately manufactured, exogenous material. •The mere possibility that heterogeneous, non-complementary DNA fragments might exist naturally within the biological sample (the basis of the Examiner's reasoning) does not fulfill the positive limitation that the material must be ‘pre-synthesized’ prior to the experiment. The Applicant's invention solves the problem of sample mix-up and contamination during the lengthy process from pre-treatment through sequencing by introducing an artificial internal marker (the pre-synthesized second nucleic acid). Ohashi et al. discloses no such exogenous, artificial marker. Claim 1 is patentable over the applied references for these reasons. The dependent claims are patentable at least due to their dependency”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection. Since the word “pre-synthesized” is read as “[S]ynthesized in advance” (see “Presynthesized Definition”), there is no definition for “Presynthesized” in the specification, and the cells from human stored blood contain a lot of presynthesized DNA moleucles, different single stranded DNAs which are not complementary from each other and stored in the cells of the human stored blood can be reasonably considered as pre-synthesized second nucleic acid recited in claim 1. Although applicant argues that “[T]he term ‘pre-synthesized’ explicitly dictates that the second nucleic acid must be manufactured by human agency (e.g., chemical synthesis prior to its introduction into the kit/sample), in contrast to naturally occurring biological material” and “[T]he Applicant's invention solves the problem of sample mix-up and contamination during the lengthy process from pre-treatment through sequencing by introducing an artificial internal marker (the pre-synthesized second nucleic acid). Ohashi et al. discloses no such exogenous, artificial marker”, claim 1 does not require that the pre-synthesized second nucleic acid is from a chemical synthesis or has exogenous artificial marker as argued by applicant. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
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 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ohashi et al., as applied to claims 1, 11, and 13-15 above, and further in view of Dunn (US Patent No. 5,776,737, published on July 7, 1998).
The teachings of Ohashi et al., have been summarized previously, supra.
Ohashi et al., do not disclose that an identification information recognizable from an outside of the container is attached to the container, and the identification information attached to the container and the base sequence of the second nucleic acid for individual identification are associated with each other as recited in claim 6, the identification information of the container is attached to a portion of the container where the recovery liquid layer is contained as recited in claim 9, and the identification information is attached in a form recognizable by an optical technique or an electromagnetic technique as recited in claim 10.
Dunn teaches that an identification code on the outside of the tube provides an indication of nature of the identification polynucleotides (see column 5, last paragraph bridging to column 6, first paragraph and Figure 6).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have performed the methods recited in claims 6, 9, and 10 wherein an identification information recognizable from an outside of the container is attached to the container, and the identification information attached to the container and the base sequence of the second nucleic acid for individual identification are associated with each other, the identification information of the container is attached to a portion of the container where the recovery liquid layer is contained, and the identification information is attached in a form recognizable by an optical technique or an electromagnetic technique in view of the prior arts of Ohashi et al., and Dunn. One having ordinary skill in the art would have been motivated to do so because Dunn teaches that an identification code on the outside of the tube provides an indication of nature of the identification polynucleotides (see column 5, last paragraph bridging to column 6, first paragraph and Figure 6). One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to perform the methods recited in claims 6, 9, and 10 by attach an identification code to a portion of the device taught by Ohashi et al., where the recovery liquid layer is contained based on his or her experimental requirements in view of the prior arts of Ohashi et al., and Dunn such that an identification information recognizable from an outside of the container is attached to the container, and the identification information attached to the container and the base sequence of the second nucleic acid for individual identification are associated with each other and the identification information is attached in a form recognizable by an optical technique (ie., capable of being observed using a light microscope) or an electromagnetic technique.
Conclusion
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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
January 19, 2026