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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-15, in the reply filed on 7/10/2026 is acknowledged. The traversal is on the ground(s) that “it should be no undue burden on the Examiner to consider all claims in the single application”. This is not found persuasive because a burden has been shown for the reasons stated in the restriction requirement dated 5/11/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim 16 (Group II) and 17-23 (Group III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. This election was made with traverse in the reply filed 07/10/2026.
Priority
Receipt is acknowledged of certified copies of papers (CN2022114781453 – filed 11/23/2022) required by 37 CFR 1.55.
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 6-14 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. Specifically, in claim 6, the claim element “a chamber” is established (“wherein the sampling element comprises an insertion end for being inserted into a chamber”. However, it is unclear regarding whether the chamber is the detection chamber established in claim 1 or another, unique chamber element. Claims 7-14 depend on rejected claim 6 and are therefore included in the rejection. For examination purposes, the chamber element will be treated as a unique chamber element.
Claim 12 recites the limitation "the sealing". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is indefinite regarding the difference of the sealing space (established in claim 10) and the sealing (claim 12) are distinct elements or the same. For examination purposes, if a hermetic or liquid sealing is provided, this will be seen as meeting the claim limitation.
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 1-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ling (US 20220323950 A1) (referenced in 892).
Regarding claim 1, Ling teaches a device for testing an analyte in a liquid sample (abstract, para. [0039]), comprising:
a detection chamber (testing chamber – See annotated FIG. 4 below, element 20), wherein the detection chamber is configured to receive as testing element (FIG. 4, element 50), and the testing element is configured to test the analyte in the liquid sample (“In one embodiment, the test element 50 is a test strip. Specifically, a plurality of test strips can be provided for testing of different analytes.” (para. [0076]); and
a sampling element, wherein the sampling element is configured to absorb a liquid (“the capillary channel at the tail end of the collection rod is put into a container in which a liquid sample is collected to absorb the sample), so that the capillary channel (FIG. 4, 111) is filled with the liquid sample, usually a blood sample.” (para. [0084]). Thus, the claim is anticipated.
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Regarding claim 2, Ling teaches the device according to claim 1. Ling further teaches a sampling element comprising a capillary channel (element 111), as the capillary channel is capable of automatically absorbing the liquid sample (para. [0084]) and is in fluid communication with the detection chamber (See annotated FIG. 4 in claim 1 rejection).
Regarding claim 3, Ling teaches the device according to claim 2. Ling further teaches a capillary channel provided in one or plurality (FIG. 4 – capillary channel element 111), and each capillary channel is capable to automatically absorb the liquid sample (para. [0084]).
Regarding claim 4, Ling teaches the device according to claim 3. Ling further teaches that after the capillary channel absorbs the liquid sample, the liquid sample is stored in the capillary channel, but is incapable to flow into the detection chamber (para. [0080 - 0084]).
Regarding claim 5, Ling teaches the device according to claim 4. Ling further teaches capillary channel comprising an inlet and outlet (FIG. 4, element 111), wherein the liquid sample flows into the capillary channel through the inlet; and the outlet is in fluid communication with the detection chamber (FIG. 4, element 111).
Regarding claim 6, Ling teaches the device according to claim 5. Ling further teaches that the sampling element comprises an insertion end for being inserted into a chamber (FIG.6 transfer chamber – element 30), and the inlet of the capillary channel is provided on the insertion end (See annotated FIG. 5 below – insertion end).
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Regarding claim 7, Ling teaches the device according to claim 6. Ling further teaches the sampling element is used to be inserted into the chamber as a whole (FIG. 8), such that pressure at the inlet of the capillary channel increases when the sampling element is inserted into the chamber (para. [0037]), and the increased pressure causes the liquid sample in the capillary channel to flow out of the outlet thereof “the mixed liquid flows into the testing chamber through the capillary channel” (para. [0037]).
Regarding claim 8, Ling teaches the device of claim 7. Ling further teaches that the chamber (buffer chamber – element 40) comprises a buffer solution (element 60 – structurally a treatment liquid therein); as when the sampling element is inserted into the chamber, the increased pressure causes the treatment liquid to flow into the capillary channel, whereby facilitating the liquid sample in the capillary channel to flow out the outlet thereof (para. [0081 - 0089]).
Regarding claim 9, Ling teaches the device of claim 7. Ling further teaches that the interior shape the chamber fits with a shape of the insertion end, such that there is only a slit between an outer surface of the insertion end and an inner surface of the chamber when the insertion end is inserted into the chamber (FIG. 8). Structurally, the slit does not allow the liquid sample to flow out of the chamber through sealing gasket (element 80) – “the testing chamber 20 forms sealing with the inner wall of the pipetting chamber 30 through the sealing gasket 80” (para. [0080]).
Regarding claim 10, Ling teaches the device of claim 8. Ling further teaches that when the insertion end is inserted into the chamber, the insertion end is combined with inner walls of the chamber to form a sealing space in the chamber (FIG. 8 – sealing space is formed); with the insertion end being further inserted into the chamber, air in the sealing space is compressed, such that air pressure in the sealing space increases, and the increased air pressure causes a part of gas or the treatment liquid to flow into the capillary channel (para. [0081]).
Regarding claim 11, Ling teaches the device of claim 10. Ling further teaches that the chamber comprises an opening (pipetting chamber – element 30), and the insertion end seals the opening of the chamber when being inserted into the chamber “the testing chamber 20 forms sealing with the inner wall of the pipetting chamber 30 through the sealing gasket 80” (para. [0080]).
Regarding claim 12, Ling teaches the device of claim 11, Ling further teaches that the sealing is a liquid sealing through sealing gasket 80 (para. [0080]).
Regarding claim 15, Ling teaches the device according to claim 1. Ling further teaches that the liquid sample is a blood sample “capillary channel 111 is filled with the liquid sample, usually a blood sample.” (para. [0084])
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ling (already referenced)
Regarding claim 13, Ling teaches the device according to claim 11, but fails to teach a buffer chamber provided between the outlet of the capillary channel and the detection chamber, as the buffer chamber allows the liquid sample flowing out the capillary channel through the outlet thereof to be mixed with the treatment liquid. Ling teaches a buffer chamber provided with buffer solution for mixing with the sample in communication with pipetting chamber 30 (para. [0081]). It has been established that rearrangement of parts are unpatentable since the rearrangement would have not modified the operation of the device (MPEP § 2144.04 VI). The rearrangement of the buffer chamber through being provided between the outlet of the capillary channel and the detection chamber would have not modified the operation of the device, as buffer chamber provided in Ling’s device provides the same structural function of providing mixing (para. [0081]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ling (already referenced) in view of Fry et al. (US 20200155127 A1) (referenced in 892).
Regarding claim 14, Ling teaches the device of claim 10, but fails to teach that the insertion end is locked with the chamber and is incapable to withdraw from the chamber. Fry et al. teaches a sampling device for collecting and dispensing a sample (abstract). Fry et al. further teaches “that sample collector and the dropper may be secured via a snap-fitting, interference or friction fit, bayonet-fitting or a clip mechanism, etc. However, in some embodiments, the securing may be such that the parts are more securely locked together than the dropper and the base, e.g., to resist separation in an axial direction.” (para. [0012]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Fry et al.’s teaching of a securing mechanism (snap-fitting, interference or friction fit, bayonet-fitting or a clip mechanism) in Ling’s device because the secure locking prevents separation in an axial direction. This method of improving Ling’s device was within the ability of one of ordinary skill in the art based on the teachings of Fry et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ling and Fry et al. to obtain the invention specified in claim 14.
Conclusion
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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