DETAILED ACTION
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 .
Response to Arguments
Applicant's arguments filed January 5, 2026 have been fully considered but they are not persuasive. Applicant has amended claims 6, 8, and 9, and argued that the amended claims overcomes the rejections under 35 U.S.C. 112(b), 35 U.S.C. 102(a)91), and 35 U.S.C. 103. The Examiner respectfully disagrees.
With respect to the rejections under 35 U.S.C. 112(b), the Examiner contends that it is unclear what structural elements make up the claimed detection device. Independent claim 6 recites “A detection device for detecting a substance to be detected in a specimen with a reaction vessel” at lines 1-2, but does not explicitly state what structural elements make up the detection device. The Examiner notes that the phrase “with a reaction vessel” does not indicate that the reaction vessel is a structural element of the detection device. As such, the Examiner has interpreted the claims as not requiring the reaction vessel or any components of the reaction vessel. Furthermore, claim 6 recites “the reaction vessel comprising” at line 3, which indicates that the additional elements of the claim (container, sidewall member, controller, light source, detector, and stirring part) are structural elements of the reaction vessel and not the detection device. Additionally, the Examiner maintains that the phrase “held portion” is indefinite as the term “held” does not describe a structural element of the reaction vessel. As such, the Examiner contends that claims 6-10 are indefinite as it is unclear what structural elements make up the detection device.
With respect to the prior art rejections, the Examiner notes that independent claim 6 has been amended to incorporate limitations previously recited in claim 7. Claim 7 was previously rejected under 35 U.S.C. 103, thus claim 6 now stands rejected under 35 U.S.C. 103 as detailed below. With respect to the combination of Kaya et al., (US 2019/0344261) in view of Sung (US 2018/0001285), Applicant has provided arguments in an attempt to show how the references do not meet the claim limitations. As detailed above, independent claim 6 is indefinite to the extent that none of the limitations recited in the claim are structural elements of the detection device. As currently presented, claim 6 recites a reaction vessel comprising a container, side wall member, controller, light source, detector, and stirring part, without claiming the reaction vessel as a structural element of the detection device. Given this view, the Examiner contends that Applicant’s arguments regarding the prior art are moot as the cited prior art teaches a detection device. Additionally, the Examiner contends that the cited prior art teach all the other limitations recited in claim 6, thus the claims are not in condition for allowance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claims 6 and 8-10, the Examiner notes that the reaction vessel, container, side wall member, controller, holding part, specimen providing unit, light source, detector, and stirring part are not recited as structural elements of the detection device. Claim 6 is directed to a detection device for detecting a substance in a specimen with a reaction vessel that comprises all the other structural element of the claim. The reaction vessel is not claimed as a structural element of the detection device; thus, it is not required that the prior art teach a detection device comprising a reaction vessel and the elements that make up the reaction vessel.
Claim Rejections - 35 USC § 112
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 6 and 8-10 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.
For claim 6, it is unclear which structural elements recited in the claim make up the detection device. Claim 6 is directed to a detection device that uses a reaction vessel to detect a substance in a specimen. The reaction vessel is not claimed as a structural element of the detection device; thus, the reaction vessel and any component of the reaction vessel are not being interpreted as structural elements of the detection device. Furthermore, claim 6 recites the reaction vessel comprising various elements which are also not claimed as structural elements of the detection device. As such, it is unclear what structural elements make up the claimed detection device. Claims 8-10 depend directly or indirectly from claim 6, and are also indefinite.
For claim 6, it is unclear what Applicant regards as the “bottom” of the container as the claims do not provide an orientation for the container in which a bottom is described.
For claim 6, it is unclear what Applicant regards as the “held portion” of the reaction vessel. The Examiner notes that it is unclear what structural element is defined by the term “held” as “held” does not describe a structural element of the reaction vessel. Also, the Examiner notes that the term "portion" is indefinite as the Examiner is unable to determine what Applicant regards as a portion. The term "portion" is sufficiently broad so as to cover a specific part of the container, or the entire container. As such, it is unclear what part Applicant regards as a held portion of the container.
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.
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.
Claim(s) 6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaya et al., (US 2019/0344261) in view of Sung (US 2018/0001285).
Regarding claim 6, Kaya et al., teach a detection unit (paragraph 0030) and an inspection chip (reaction vessel, paragraph 0032), a well main body (container, paragraph 0066) having a first opening (first opening, paragraph 0068), a second opening on a side wall (second opening, paragraph 0068), and a side wall member including a prism and a metal film on the prism (paragraph 0076), a holding unit (holding part, paragraph 0061), and a liquid delivery means (specimen providing unit, paragraph 0055), a light source (paragraph 0036), a light receiving sensor (detector, paragraphs 0046 0051), a stirring device (paragraphs 0032, 0033), and a pipette (sample providing unit, paragraph 0058). Kaya et al., teach a stirring device turning a bottom of a container (paragraphs 0032, 0033, figure 8), but do not teach a holding part including a first rotary shaft extending in a first direction and a second rotary shaft that extends in a direction orthogonal to the first direction.
Sung teaches a shaker device comprising a holder for holding tubes (paragraphs 0014, 0016, 0034), a first eccentric shaft extending in a first direction (first rotary shaft, paragraphs 0019, 0027, figure 7 #310), and a drive shaft extending in a second direction orthogonal to the first direction (second rotary shaft, paragraphs 0021, 0035, figure 7 #330) wherein rotation of the first eccentric shaft and drive shaft results in mixing a sample in the tubes (paragraph 0035). Sung teaches that it is advantageous to provide an eccentric shaft extending on a first direction, and a drive shaft extending in a direction orthogonal to the first direction as a means of shaking and rotating test tubes to mix a specimen (paragraph 0035).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kaya et al., wherein a holding part comprises a first rotary shaft extending in a first direction, and a second rotary shaft extending in a second direction orthogonal to the first direction in order to mix a specimen by shaking and rotating test tubes as taught by Sung.
Regarding claims 8 and 9, Kaya et al., teach the stirring device being conical or spherical (paragraph 0072). Kaya et al., teach the stirring part having the same shape as the bottom of the well body which can be curved, a pyramid, or a protrusion (paragraph 0072). The Examiner again notes that the container is not a structural element of the detection device, thus the shape of the container has not been given patentable weight.
Regarding claim 10, Kaya et al., teach detecting fluorescence from a sample (paragraph 0046).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797