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 without traverse of Group I, claims 1-16, drawn to a sample analysis device in the reply filed on 06/02/2026 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/15/2023, 04/01/2024, 03/03/2025, and 07/09/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,681,529A-Taguchi et al (hereinafter “Taguchi”).
Regarding claim 1, Taguchi discloses a sample analysis device (biological fluid analyzing device, abstract; provide a biological fluid analyzing device, col. 2, lines 50-51), comprising a base (lower plate 8, col. 4, line 63, Fig. 2B) and one or more sample analysis units (sample treating chamber 2b, Fig. 1, arranged on lower plate 8, shown in Fig. 1) provided on the base (lower 8, Fig. 1), wherein each sample analysis unit includes: a liquid storage chamber (chamber 2a, col. 2, line 67, Fig. 1, where chamber 2a is arranged on lower plate 8, Fig. 1) arranged on the base (lower plate 8, Fig. 1);
“an optical imaging chamber (optical measuring chamber 3a, 3b, col. 2, line 67, shown arranged on lower plate 8, Fig. 1) arranged on the base (lower plate 8, Fig. 1), wherein a side of the optical imaging chamber is connected to the liquid storage chamber (optical chamber 3a is connected to chamber 2a—liquid storage chamber, shown in Fig. 1);”
“a drainage chamber (waste liquid reservoir 4, col. 3, line 3, arranged on lower plate 8, Fig. 1) arranged on the base, wherein the drainage chamber is connected to the other side of the optical imaging chamber (waste reservoir 4 is connected to optical chamber 3b via pathway 6, shown in Fig. 1), the drainage chamber (waste reservoir 4, Fig 1) is provided with an opening (port 5, col. 3, line 30, Fig. 1) connecting with atmosphere;”
“and a sealing member (upper plate 7, col. 6, lines 63, Fig. 2B) removably (upper plate 7 seals lower plate 8 comprising the chambers and openings, Fig. 2B) sealing the opening.”
Regarding claim 2, Taguchi discloses wherein the sealing member includes a sealing plug, a sealing membrane, or a sealing cap (upper plate 7, shown in Fig. 2B).
Regarding claim 3, Taguchi discloses wherein the sample analysis unit further includes a pressure-applying member configured to apply a negative pressure to the drainage chamber (a pump (not shown) connected to the pump connection port 5, col. 5, lines 62-63; the pump connection port 5 is connected with a pathway 6 or waste liquid reservoir 4, abstract, lines 11-12, Fig. 1).
Regarding claim 8, Taguchi discloses wherein optical imaging chambers (3a and 3b—optical measuring chamber) of at least two sample analysis units are connected (optical measuring chambers 3a and 3b are shown connected to chamber 2b, Fig. 6).
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.
Claims 4, 9-10, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,681,529A-Taguchi et al (hereinafter “Taguchi”).
Regarding claim 4, Taguchi discloses a liquid storage chamber (chamber 2a, Fig. 1) and a drainage chamber (waste reservoir 4, Fig. 1) located at two ends of the optical chamber (3a, 3b) along a length direction, shown in Fig. 1. Moreover, Taguchi discloses the claimed invention except for wherein the optical imaging chamber is a bar shape. It would have been obvious to one having ordinary skill in the art to include an optical imaging chamber is a bar shape, because Taguchi teaches there are no restrictions on the size, shape or material of the biological fluid analyzing device, and the only requirement is that the device be so sized as to be accommodated in common easy operational clinical test apparatuses (col. 5, lines 8-11). See MPEP §2144.04(IV).
Regarding claim 9, Taguchi teaches the invention discussed above in claim 1. Further, Taguchi teaches a optical imaging chamber. However, Taguchi does not explicitly teach a transparent cover over a top of the optical imaging chamber.
For claim 9, a different embodiment of Taguchi, referring to Fig. 15, which teaches a gas-permeable film 17 of the lower plate 8 (col. 9, line 41, Fig. 15), and Taguchi teaches the film may be formed of polycarbonate (col. 9, line 49, where polycarbonate is known in the art to inherently transparent), which reads on the instant claim limitation of a transparent cover over a top of the optical imaging chamber.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include a transparent cover over a top of the optical imaging chamber as taught by a different embodiment of Taguchi, because the different embodiment of Taguchi teaches the gas-permeable film help supply oxygen (col. 3, lines 43-44).
Regarding claim 10, Taguchi teaches the invention discussed above in claim 1. Further, Taguchi teaches a sealing member connected to an opening, discussed above and shown in Fig. 2B. However, Taguchi does not explicitly teach the sealing member is capable of converting between a sealed state and a non-sealed state.
For claim 10, a different embodiment of Taguchi teaches an opening (hole 21, col. 7, lines 62, Fig. 17), where opening (hole 21, Fig. 17) is capable of converting between a sealed state and a non-sealed state (this air hole 21 is closed to enable the plasma to be drawn in by the pump. When moving the sample thereafter, the air hole is opened to make the flow of plasma smooth, col. 7, lines 62-65), which reads on the instant claim limitation of the sealing member is capable of converting between a sealed state and a non-sealed state.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Taguchi and further include a sealing member is capable of converting between a sealed state and a non-sealed state as taught by a different embodiment of Taguchi, because the different embodiment teaches a retainer portion 19 make small the pores in the clamped portion of the filter and thereby prevent leakage of blood cells improving the effectiveness of separation between blood cells (col. 7, lines 65-66 and col. 8, lines 1-4).
Regarding claim 15, Taguchi discloses wherein the sample analysis unit further includes a pressure-applying member (pressure from a pump connected to the pump connection port 5, col. 3, lines 7-8) configured to apply a negative pressure to the drainage chamber; and the pressure-applying member is arranged on the sealing member (the pump connection port 5, which connects a pump is disposed on upper plate 7, shown in Fig. 6), further, the pressure supplied by the pump which is connected to the port 5, travels through waste liquid reservoir 4, shown in Fig. 1.
Regarding claim 16, Taguchi discloses wherein the pressure- applying member includes an air pump (pressure from a pump connected to the pump connection port 5, col. 3, lines 7-8), the air pump is connected to the sealing member (the pump connection port 5, which connects a pump is disposed on upper plate 7, shown in Fig. 6), the sealing member is controlled, by the air pump, to be opened or closed to control the drainage chamber to connect or disconnect atmosphere, and a negative pressure is applied to the drainage chamber through the air pump (port 5, which connects a pump, is disposed on upper plate 7, which couples to waste liquid reservoir 4, shown in Fig. 1).
Allowable Subject Matter
Claims 5-7, and 11-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 5, the prior art fails to teach or fairly suggest wherein the optical imaging chamber is connected to the liquid storage chamber through a first passage, an area of a cross-section of the first passage perpendicular to a length direction of the first passage being smaller than an area of a cross-section of the optical imaging chamber perpendicular to the length direction of the first passage, the area of the cross-section of the first passage perpendicular to the length direction of the first passage being larger than a maximum cross-section area of a sample particle to be tested, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the optical imaging chamber is connected to the liquid storage chamber through a first passage, an area of a cross-section of the first passage perpendicular to a length direction of the first passage being smaller than an area of a cross-section of the optical imaging chamber perpendicular to the length direction of the first passage, the area of the cross-section of the first passage perpendicular to the length direction of the first passage being larger than a maximum cross-section area of a sample particle to be tested.
The following is a statement of reasons for the indication of allowable subject matter: for claim 6, the prior art fails to teach or fairly suggest wherein the optical imaging chamber is connected to the drainage chamber through a second passage, an area of a cross-section of the second passage perpendicular to a length direction of the second passage being smaller than an area of a cross-section of the optical imaging chamber perpendicular to the length direction of the second passage, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the optical imaging chamber is connected to the drainage chamber through a second passage, an area of a cross-section of the second passage perpendicular to a length direction of the second passage being smaller than an area of a cross-section of the optical imaging chamber perpendicular to the length direction of the second passage.
The following is a statement of reasons for the indication of allowable subject matter: for claim 7, the prior art fails to teach or fairly suggest wherein the liquid storage chamber is provided with a dyeing reagent layer or a reagent pre-embedding chamber, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the liquid storage chamber is provided with a dyeing reagent layer or a reagent pre-embedding chamber.
The following is a statement of reasons for the indication of allowable subject matter: for claim 11, the prior art fails to teach or fairly suggest wherein the sealing member includes a connecting member, the connecting member is removably inserted in the opening, a gas channel is provided in the connecting member, the connecting member is moved to convert between a state of the gas channel to connect the drainage chamber and atmosphere and a state of the gas channel to disconnect the drainage chamber and the atmosphere, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the sealing member includes a connecting member, the connecting member is removably inserted in the opening, a gas channel is provided in the connecting member, the connecting member is moved to convert between a state of the gas channel to connect the drainage chamber and atmosphere and a state of the gas channel to disconnect the drainage chamber and the atmosphere.
The following is a statement of reasons for the indication of allowable subject matter: for claim 12, the prior art fails to teach or fairly suggest wherein the sealing member further includes a button arranged at an end of the connecting member away from the base, the connecting member is sleeved with a first spring member, and the first spring member is located between the button and the base, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the sealing member further includes a button arranged at an end of the connecting member away from the base, the connecting member is sleeved with a first spring member, and the first spring member is located between the button and the base.
The following is a statement of reasons for the indication of allowable subject matter: for claim 13, the prior art fails to teach or fairly suggest wherein the sealing member includes a top cover, a sealing gasket, a fixing member, and a second spring member, the sealing gasket is arranged under the top cover and corresponding to the opening, the fixing member passes through the top cover and maintains a fixed position relative to the drainage chamber, the fixing member is provided with a groove matching with the top cover, the second spring member is sleeved on the fixing member, and the second spring member is located between the top cover and the base, the sealing gasket seals the opening when the top cover is snapped into the groove, and the second spring member is capable of pushing the top cover to move to open the opening when the top cover is pushed to disengage the top cover from the groove, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the sealing member includes a top cover, a sealing gasket, a fixing member, and a second spring member, the sealing gasket is arranged under the top cover and corresponding to the opening, the fixing member passes through the top cover and maintains a fixed position relative to the drainage chamber, the fixing member is provided with a groove matching with the top cover, the second spring member is sleeved on the fixing member, and the second spring member is located between the top cover and the base, the sealing gasket seals the opening when the top cover is snapped into the groove, and the second spring member is capable of pushing the top cover to move to open the opening when the top cover is pushed to disengage the top cover from the groove.
The following is a statement of reasons for the indication of allowable subject matter: for claim 14, the prior art fails to teach or fairly suggest wherein the sealing member further includes a handle, and the handle is arranged on the top cover, wherein these limitations are in combination with the claim as whole.
The closest prior art is US 5,681,529A-Taguchi et al (hereinafter “Taguchi”). Taguchi teaches a biological fluid analyzing device for analyzing biological fluid by measuring optical characteristics of a sample has a sample receiving port 1 and a pump connection port 5. However, Taguchi does not explicitly teach wherein the sealing member further includes a handle, and the handle is arranged on the top cover.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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