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 .
Applicant’s filing of claims 1-5 on 7/10/23 is acknowledged. Claims 1-5 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/10/23 and 4/29/25 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
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 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.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ozeki et al. (“Ozeki,” US Pub. No. 2012/0197008, cited in IDS) in view of Tadenuma et al. (“Tadenuma,” US Pub. NO. 2015/0065377, cited in IDS).
As to claim 1, Ozeki teaches a nucleic acid sequence measurement method for measuring a target RNA having a specific nucleic acid sequence included in a cell suspension by hybridization (e.g., [0069] et seq. teaches hybridization; and [0117] et seq. teaches nucleic acid examples as the target), comprising:
a step of heating the cell suspension at 100° C. to 200° C. in a pressurized state to obtain an RNA extract (e.g., [0021] et seq. teaches boil-lock type tube having mechanical structure for sealing purposes to serve as a vessel for housing the cell suspension); a step of adding a proteolytic enzyme to the RNA extract to cause the RNA extract to be reacted, thereby preparing a sample solution (e.g., enzyme such as proteinase K in [0098] et seq.); and a step of measuring fluorescence from the device for nucleic acid sequence measurement (see e.g., [0075] et seq.).
Regarding claim 1, Ozeki does not specifically teach a step of supplying (“supplying step”) the sample solution to a device for nucleic acid sequence measurement, the device being equipped with a fluorescent probe that hybridizes with the target RNA; and a step of subjecting (“subjecting step”) the target RNA and the fluorescent probe to a hybridization reaction. Tadenuma teaches in e.g., [0060] et seq., in FIG. 4, a sample solution containing a sample 50 is prepared using a method known to a person skilled in the art, and then the gene (target 30) in the sample 50 is amplified (Step 1). Next, the target 30 and the fluorescent probe 10 are hybridized by supplying the sample solution containing the amplified target 30 to the solid surface 100 of the DNA chip (Step 2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the supplying and subjecting and subjecting steps because the combination of steps in addition to Ozeki would provide a nucleic acid sequence measuring method with excellent detection sensitivity including a simplified nucleic acid detection step ([0029] of Tadenuma).
As to claim 2, the combination of Ozeki and Tadenuma teach in the step of measuring the fluorescence, the fluorescence from the device for nucleic acid sequence measurement is measured without washing the sample solution supplied to the device for nucleic acid sequence measurement (see [0031] et seq. of Tadenuma). For motivation statement, see above.
As to claim 3, the combination of Ozeki and Tadenuma teach in the step of obtaining the RNA extract, the cell suspension is heated in a sealed container (see [0012] et seq. of Ozeki). For motivation statement, see above.
As to claim 4, the combination of Ozeki and Tadenuma teach the proteolytic enzyme is a proteinase K (see [0098] et seq. of Ozeki). For motivation statement, see above.
As to claim 5, the combination of Ozeki and Tadenuma teach
wherein the device for nucleic acid sequence measurement is equipped with a fluorescent probe having a binding part and a proximal end, and having a fluorescent molecule attached to a distal end or an intermediate position (figs. 1-11B and [0011] et seq. of Tadenuma),
a quenching probe having a binding part and a proximal end, and having a quenching molecule attached to a position near the fluorescent molecule of the fluorescent probe in a case where the quenching probe binds to the fluorescent probe (figs. 1-11B and [0011] et seq. of Tadenuma), and
a substrate having a solid-phase surface on which the proximal end of each of the fluorescent probe and the quenching probe is immobilized (figs. 1-11B and [0011] et seq. of Tadenuma),
wherein the binding part of the fluorescent probe and the binding part of the quenching probe have sequences complementary to each other (figs. 1-11B and [0011] et seq. of Tadenuma) and,
at least one of the fluorescent probe and the quenching probe has a detection part having a sequence complementary to a nucleic acid sequence of the target RNA (figs. 1-11B and [0011] et seq. of Tadenuma),
in a case where a hybridization between the target RNA and the detection part does not occur, binding between the binding part of the fluorescent probe and the binding part of the quenching probe is maintained, and fluorescence exhibited by the fluorescent molecule is consequently quenched by the quenching molecule approaching the fluorescent molecule (figs. 1-11B and [0011] et seq. of Tadenuma), and
in a case where the hybridization between the target RNA and the detection part occurs, the binding between the binding part of the fluorescent probe and the binding part of the quenching probe is dissociated consequently, and the proximal end of each of the fluorescent probe and the quenching probe is immobilized on the solid-phase surface to cause a positional relationship so that the fluorescent molecule separated from the quenching molecule exhibits fluorescence (figs. 1-11B and [0011] et seq. of Tadenuma). For motivation statement, see above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
2/20/2026