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 .
Status of Claims
The claim set submitted on 15 SEPTEMBER 2025, Claim 1 has been amended to include the limitation of Claim 2; Claim 2 has been cancelled; Claims 3 and 4 are original.
Current pending claims are Claims 1, 3 and 4 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 JULY 2025 was filed after the mailing date of the Non-Final Office Action on 16 JUNE 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Applicant’s arguments, see REMARKS, filed 15 SEPTEMBER 2025, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over KO, KR 10-2016-0064278 A, submitted on the Information Disclosure Statement on 13 DECEMBER 2022, Foreign Patent Documents Cite No. 2, and further in view BROWN, US Publication NO. 2011/0000868 A1.
An English Machine Translation has been obtained from Google Patent and is used for the basis of the rejection below. The English Translation it cited on the PTO-892 and is attached with this Office Action.
Applicant’s invention is directed to a device, a sample pretreatment tube.
Regarding Claim 1, the KO reference discloses a sample pretreatment tube , Figure 2, cartridge 200, page 5/11, comprising: a cap, Figure 1 and 2, elastic body 150, page 5/11; a first tube, Figure 1 and 2, chamber 220, page 5/11 to 7/11, coupled at an upper portion thereof to the cap, Figure 1 and 2, and formed at a lower portion thereof with a separation membrane having a predetermined thickness to receive a primary reagent therein, Figure 1, separation membrane 250 and liquid material 20, page 5/11 to 7/11; a second tube coupled to the lower portion of the first tube and receiving a secondary reagent therein, Figure 1, chamber 230 and liquid material 30, page 5/11 to 7/11.
The KO reference discloses the claimed invention but is silent in regards to a stopper formed inside the first tube to limit an insertion depth of a pipette inserted into the sample pretreatment tube and to facilitate a flow of a reaction solution and wherein the stopper comprises multiple stopper wings protruding radially inwards from an inner surface of the first tube.
The BROWN reference discloses a sample pretreatment tube comprising:
a cap, Figure 9, nipple 25, [0075];
a first tube coupled at an upper portion thereof to the cap, Figure 7, when assembled, nipple 25 and receptable portion 25 are together, and formed at a lower portion thereof, Figure 9, receptacle portion 25, [0075], Figure 27, reservoir 126, [0093, 0094, to receive a primary reagent therein, [0009];
a second tube coupled to the lower portion of the first tube, Figure 9, container 18, [0075]; and
a stopper formed inside the first tube to limit an insertion depth, Figure 27, lip/bulge 121/124 and lip/bulge 122/125, [0093], and to facilitate a flow of a reaction solution, [0005, 0092],
wherein the stopper, Figure 27, 27A, comprises multiple stopper wings protruding radially inward from an inner surface of the first tube, Figure 27A, see ‘wings’ protruding radially inward, the multiple stopper wings being axially spaced apart from the separation membrane and radially arranged at regular intervals so as to allow the reaction solution to flow between each of the multiple stopper wings, Figure 27A, [0093, 0094].
In the claim language which recites ‘to limit an insertion depth of a pipette inserted into the sample pretreatment tube and to facilitate a flow of a reaction solution’ is directed towards the intended use of the stopper and the wings. The pipette is not structurally part of the instant invention and has been given a relative amount of patentable weight. It has been interpreted by the Examiner that stopper is to limit the insertion depth into the sample pretreatment tube.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the KO reference with the stopper comprising multiple stopper wings protruding radially inward as taught by BROWN promote flow and venting of the fluid within the device.
Additional Disclosure Included is: Claim 4: wherein the sample pretreatment tube according to claim 1, further comprising: an additional tube disposed between the first tube and the second tube and formed at a lower portion thereof with a separation membrane having a predetermined thickness to receive an additional reagent therein, KO, Figure 2, chambers 220, 230 and 210, sample analysis cartridge having three storage chambers in connection with the sample analysis cartridge, where chamber 230 has liquid 30, page 5/11 to 7/11.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over KO, KR 10-2016-0064278 A, submitted on the Information Disclosure Statement on 13 DECEMBER 2022, Foreign Patent Documents Cite No. 2, in view of BROWN, US Publication NO. 2011/0000868 A1, and further in view of SHON , KR 10-2013-0000273 A.
Regarding Claim 3, the combination of KO in view of BROWN suggests the claimed invention, including a second tube coupling portion having a connection thread formed on a lower inner surface of the first tube, KO Figure 2, chamber 230 and 210 are connected by threading, page 6/11; and a grip formed on a lower outer surface of the first tube, Figure 4(c), chamber 220 has grips., but is silent in regards to wherein the first tube comprises: a cap coupling portion having a first tube thread formed on an upper outer surface of the first tube.
The SHON reference discloses a sample pretreatment tube, Figure 2-4, comprising: a cap, Figure 2-4, cover 20; a first tube coupled at an upper portion thereof to the cap, Figure 2-3, container body 10 is coupled to at an upper portion by screw portion 13 to the matching screw portion in cover 20, and formed at a lower portion thereof with a separation membrane having a predetermined thickness, Figure 2, film 24, and wherein the first tube comprises: a cap coupling portion having a first tube thread formed on an upper outer surface of the first tube, Figure 2-3, inner cover 20 is screwed to screw portion 13 (thread) formed on upper outer surface of container body 10, pages 2-4.
It would be obvious to one having ordinary skill in the art before the effective filing date to include a cap coupling portion having a first tube thread formed on an upper outer surface of the first tube as taught by SHON to the combination of KO in view of BROWN create a tight seal, preventing any leakage, spillage or evaporation when not in use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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