DETAILED ACTION
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 .
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1-6, in the reply filed on 26 June 2026 is acknowledged.
Applicant’s comment clarifying that claim 20 depends from claim 14 is acknowledged.
Claim Status
3. Claims 1-20 are pending.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-6 read on the elected invention and have been examined herein.
Specification
4. The phrase “Cy3 (registered trademark),” is noted in this application (p. 8, line 2). Trade names or marks used in commerce should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
This is one example of a trademark that is used in the specification. The specification should be reviewed for any additional trademarks or trade names and the terms should be accompanied by their generic terminology and capitalized or where appropriate accompanied by a proper symbol.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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.
Claims 1-6 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.
Claims 1-6 are indefinite over the recitation of “when a solution containing a light-absorbing substance that absorbs excitation light …is in contact with a solid-phase surface of a substrate…., measuring a fluorescence.” In view of the “when” clause at the beginning of the claim, it is unclear as to what embodiments or steps are required by the claims. For instance, it is unclear as to whether the claims include the possibility that the solution isn’t in contact with the solid surface, and then no step of measuring fluorescence is performed. It is also unclear as to how the claim accomplishes the objective of measuring a target contained in a sample since the single process step of measuring does not recite the use of a sample and the claim does not recite a nexus between measuring the fluorescence and the detection of a target contained in the sample.
Claims 1-6 are indefinite over the recitation of “fluorescence obtained by irradiation of the excitation light from an opposite side to the solid-phase surface of the substrate from the opposite side to the solid-phase surface of the substrate.” First, it is unclear as to what “the opposite side” is relative to – e.g., the side of the solid phase substrate on which the capture molecule or target are bound, or the side on which a solution containing a light-absorbing substance is present, or a side that emits the fluorescence or to the left or right of a location at which a capture molecule or target is bound, etc. Secondly, it is unclear as what is meant by the recitation of “an opposite side to the solid-phase surface of the substrate from the opposite side to the solid-phase surface of the substrate.”
Claims 2-5 are indefinite because the claims previously recite “a bound product of the target and a capture molecule” but do not previously recite that the capture molecule is immobilized or that the target is immobilized on the solid-surface. Accordingly, the recitations of “the capture molecule immobilized on the solid-phase surface” (claims 2 and 4) and “the target immobilized on the solid-phase surface” (claim 3) lack proper antecedent basis.
Claim 5 is indefinite over the recitation of “supplying either one of the target and the capture molecule immobilized on the solid-phase surface and the fluorescent molecule to the other of the target and the capture molecule.” This phrase is not clearly defined by the specification or the claims and there is no clear art recognized definition for this phrase.
Claim Rejections - 35 USC § 102
6. 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 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner et al (U.S. Patent No. 4,680,275; cited in the IDS of 19 December 2025).
Wagner teaches a method for detecting a target (analyte) present in a sample, the method comprising: combining a capture molecule bound to a solid-phase surface with a solution that contains a light-absorbing substance (e.g., 1,8-ANS), wherein the capture molecule specifically binds to the target (analyte) and the target (analyte) ”is modified with a fluorescent molecule” (i.e., binds to a tracer that emits fluorescent light); and measuring a fluorescence emitted by irradiating the solid phase substrate from the side that is opposite of the side to which the capture molecule is bound (e.g., Figure 1; col 6, lines 35-55; and Example 3, beginning at col. 8, line 53). Note that in Figure 1, “LIGHT” is applied from outside the solid surface substrate (and the pathway of the light is designated “31”); the target (analyte) is designated “23”; the fluorescent tracer is designated “25”; and the capture molecule (anti-analyte or antibody therein) is designed “19” (see col. 6, lines 35-55).
Wagmer teaches “(a) light absorbing material is added to the assay system either before or after the immunological reaction, and may be any material which has an absorption band which overlaps the absorption band of the tracer and which does not interfere with the immunological reaction. Suitable absorbing materials are exemplified by, but not limited to, stilbenes, benzoxazoles, naphthalenes and derivatives thereof. A preferred group is the arylaminonaphthalene sulfonic acids, as, for example, 2-(p-anisidinyl) naphthalene-6-sulfonic acid or 1-anilinononaphthalene-8-sulfonic acid (1,8-ANS)” (col. 5, line 53-63).
Wagner (col. 6, line 28 to 34) states “The light absorbing material in the fluid phase of the assay system absorbs all excitation and/or emission light which passes through the fluid phase and thereby effectively prevents detection of emission from free tracer. On the other hand, bound tracer absorbs and subsequently emits detectable light which has not passed through the fluid phase.”
Regarding claims 2 and 5, Wagner teaches that the target (analyte) is modified by binding to the fluorescent molecule (tracer), which is bound to the capture molecule (anti-ligand / antibody) bound to the solid-phase surface (see, e.g., Figure 1; col. 2 line 55 to col. 3, line 13; and col. 4, lines 34-49).
Regarding claims 3-4, these claims do not require directly modifying the capture molecule by binding the capture molecule directly to a fluorescent molecule. The claims include modifying the capture molecule indirectly by binding the capture molecule to the target which is bound to the fluorescent molecule. Further, regarding claim 3, the claim does not define the capture molecule and target by any particular structural properties. Also, the claim does not include an active step of measuring a target and thereby the preamble of the claim does not distinguish the claimed method over that of Wagner. In the method of Wagner, the molecule bound to the solid support can be viewed as a target molecule and the molecule that binds thereto can be viewed as a capture molecule. By binding the immobilized molecule to the solid surface and binding the other molecule to the fluorescent molecule and to the molecule bound to the surface, the method results in a capture molecule (indirectly) bound to a fluorescent molecule and obtaining the bound product of a capture molecule and target molecule immobilized on the solid surface.
Claim Rejections - 35 USC § 103
7. 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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner in view of Suzuki (U.S. 20090176313).
The following rejection applies to claim 3 to the extent that this claim may intend to require that the target (analyte) is immobilized on the solid-phase surface prior to being contacted with a fluorescently labeled capture molecule (anti-analyte/antibody).
The teachings of Wagner are presented above. Wagner does not teach a method wherein the target (analyte) is immobilized on the solid-phase surface prior to being contacted with a fluorescently labeled capture molecule (anti-analyte / antibody).
However, Suzuki (para [0054]) teaches methods of performing an immunoassay. It is disclosed that one conventional method for performing an immunoassay to detect a target analyte (analyte / antigen) is to immobilize the target prior to performing a step of contacting the immobilized target (analyte / antigen) with a fluorescently labeled antibody/capture molecule. In particular, Suzuki (para [0054]) teaches:
“in cases where a target antigen in a test sample is to be measured by a sandwich immunoassay, a primary antibody to the target antigen is immobilized on a solid phase, the immobilized primary antibody is then reacted with the test sample, thereby binding the target antigen in the test sample to the immobilized primary antibody. After washing, a secondary antibody labeled with the fluorescent labeling agent is then reacted. After washing, the fluorescent labeling agent attached to the secondary antibody bound with the target antigen is made to emit fluorescence with an excitation light by a conventional method, and the fluorescence is measured.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Wagner so as to have performed the immunoassay using a target analyte (antigen) that is immobilized on the solid-phase surface and to have contacted the immobilized analyte with a fluorescently labeled antibody (capture molecule), as taught by Suzuki. One would have been motivated to have done so because Suzukii teaches that this is an effective, conventional means for performing immunoassays for the detection of a target analyte (antigen) in a sample.
8. Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tadenuma et al (U.S. 20150065377; cited in the IDS) in view of Tanaami et al (WO 2018/142880), as evidenced by Tanaami et al (U.S. 2021/0325305).
It is noted that Tanaami et al (WO 2018/142880) is the WIPO publication of PCT/JP2018/000676 and was published in Japanese. Tanaami et al (U.S. 2021/0325305) is the National Stage application of PCT/JP2018/000676. The contents of U.S. 2021/0325305 is considered to be the same as that of WO 2018/142880. U.S. 2021/0325305 is cited as the English translation of WO 2018/142880. That is, U.S. 2021/0325305 is cited herein only to establish what is inherent to the teachings of Tanaami et al (WO 2018/142880). Citations below are with respect to the specification of U.S. 2021/0325305.
Tadenuma teaches a method for detecting a target nucleic acid in a sample, the method comprising contacting a capture probe immobilized on a solid surface, such as a DNA chip, with a target nucleic acid under hybridization conditions to generate a bound product, wherein the immobilized probe comprises a nucleotide sequence complementary to the target nucleic acid and wherein the target nucleic acid has a fluorescent moiety attached thereto; and detecting the presence or absence of the target nucleic acid in the sample based on the detection of a fluorescence signal emitted by the target nucleic acid bound to the immobilized capture probe (e.g., para [0005-0010]]).
Takenuma also teaches methods for detecting a target nucleic acid wherein a capture probe is immobilized on a solid surface that is a DNA chip and the capture probe is labeled with a fluorophore and is considered to be a detection probe; and wherein a target nucleic acid is hybridized with the immobilized, fluorescently labeled capture / detection probe to obtain a bound product, as required by present claim 6 (see, e.g., para [0055-0063]; and Figures 1-3). Takenuma teaches irradiation of the fluorescent molecule with the excitation light, from a side that is considered to be opposite of the side portion of the chip / solid support, and that the irradiation causes the fluorescent molecule to emit fluorescent light (e.g., para [0063] and Figure 4).
Takenuma does not each that a solution containing a light-absorbing substance that absorbs excitation light that excites a fluorescent molecule or fluorescence emitted from the fluorescent molecule is in contact with the chip / solid-phase surface of the substrate.
However, Tanaami teaches a biochip to be used to detect fluorescence emitted as indicative of the presence of a target molecule and can be used for nucleic acid hybridization assays or antigen-antibody reactions (e.g., para [0026], [0050-0051] and [0083]).
Tanaami teaches that the sample solution applied to the biochip may be a black solution (para [0025]).It is stated that “a black solution for reducing background light in fluorescence measurement is employed as the sample solution” (para [0045]). It is also stated that “The black solution absorbs stray light other than fluorescence and crosstalk light from an adjacent site. The site is directly joined to the microlens, and therefore, the light from the site heads to the reading device without passing through the black solution. Thus, background light in fluorescence measurement can be reduced, and therefore, the optical noise in fluorescence measurement can be further reduced” (para [0078]). Tanaami also teaches that the molecular reaction site – i.e., the site at which the nucleic acid hybridization assay occurs – is on a side opposite of the side of the surface which is irradiated with the light (e.g., para [0054] and Figure 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Takenuma so as to have provided the sample containing the target nucleic acid in a black solution as taught by Tanaami. One would have been motivated to have done so for the benefit disclosed by Tanaami that the black solution absorbs stray light and reduces background noise in fluorescent measurement assays, thereby increasing the accuracy of the target detection assay.
Regarding claims 2 and 5, as discussed above, Takenuma (para [0005-0010] teaches the embodiment wherein the target nucleic acid is labeled with a fluorescent molecule and the capture probe, comprising a nucleic acid sequence complementary to a portion of the target nucleic acid, is immobilized on the solid surface / chip.
Regarding claims 3-4 and 6, Takenuma teaches methods in which the capture probe is a detection probe that is labeled with a fluorescent moiety and the target is immobilized by binding the target to the capture / detection probe immobilized on the chip / solid surface (e.g., Figures 1, 3 and 4; and para [0062]). Note that with respect to claim 3, the claim does not require that the target is directly immobilized on the solid-phase surface / chip but includes indirectly immobilizing the target via binding of the target to the capture / detection probe.
9. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tadenuma et al (U.S. 20150065377; cited in the IDS) in view of Tanaami et al (WO 2018/142880), as evidenced by Tanaami et al (U.S. 2021/0325305) and further in view of Dobrowolski, Z.L. (U.S. 20030124581).
As discussed in paragraph 8 above, U.S. 2021/0325305 is cited herein only to establish what is inherent to the teachings of Tanaami et al (WO 2018/142880). Citations below are with respect to the specification of U.S. 2021/0325305.
The following rejection applies to claim 3 to the extent that this claim may intend to require that the target nucleic acid is immobilized on the solid-phase surface prior to being contacted with a fluorescently labeled capture molecule / detection probe.
The combined teachings of Tadenuma and Tanaami are presented above. The combined references do not reach a method wherein the target nucleic acid is immobilized on the solid-phase surface prior to being contacted with a fluorescently labeled capture molecule / detection probe.
However, Dobrowolski teaches nucleic acid detection assays wherein a target nucleic acid is immobilized on a chip / solid-support substrate; hybridized with a fluorescently labeled probe; and the fluorescent signal emitted by the probe bound to the immobilized target nucleic acid is detected as indicative of the presence of the target nucleic acid (e.g., para [0007] and [0026]). The reference (para [0026] states:
“[0026] Hybridization is the process of incubating the immobilized target DNA tethered on the glass substrate with the labeled probe DNA at a particular temperature. The fluorescent probe DNA will hybridize with the primer-amplified target DNA, will be washed at a probe specific temperature, and the amount of immobilized fluorescence can be determined by scanning.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Tadenuma so as to have performed the hybridization reaction using a target nucleic acid immobilized on a chip / solid-phase surface and to have contacted the immobilized target nucleic acid with a fluorescently labeled probe, as taught by Dobrowolski. One would have been motivated to have done so because Dobrowolski teaches that this is an effective means for performing hybridization assays for the detection of a target nucleic acid in a sample.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
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