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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 11, 2026 has been entered.
Claim Status
Claims 1, 4-8, 10, and 11 are pending.
Claims 2, 3, and 9 are canceled.
Claims 1, 6, 7 are amended.
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, 6, and 8 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Skeggs (US 3699004 A).
Regarding claim 1, Skeggs teaches “An automatic analyzing apparatus comprising:” (Para (3), New and improved method and apparatus for the fully automatic, highly accurate quantitative analysis of a series of samples with regard to a constituent thereof on a continuous flow basis through rate reaction determination are provided and are operable through the continuous mixing of said samples.);
“a feeder configured to feed a diluent and a high concentration liquid,” (Paras (32-34) and Fig 1, The fluid sample and substrate supply means 22 comprising turntable 34 upon which is disposed a generally circular array of blood sample containers 36. In which the outlet end of the sample offtake probe 40 is connected as indicated to the inlet end of the compressible pump tube 54, while the inlet end of the compressible pump tube 56 extends as shown into a substrate container 62 to pump substrate from the latter. The pump 52 which has the pump tubes connected to the probe for the sample and the substrate.) Therefore, the pump is the feeder that is configured to feed liquids. The recitation “diluent” and “high concentration liquid” in addition to
“the high concentration liquid including a concentration of a detergent component that provides a higher detergency than the diluent” is a capability of the feeder. Skeggs teaches the positively claimed structural elements of the feeder as claimed, such feeder is said to be fully capable of the recited operation. The fluid flowing through the apparatus is considered material worked upon and is not given patentable weight in claims to an apparatus.
Further taught “and a mixer unit comprising an inflow part, an internal space, and an outflow part” (Para (46) and Fig 2, mixing coil is indicated at 108 which the conduit 106 is fed into. The inflow part is the side closest to 106, the outflow part is the part closest to 109 and the internal space is the coil part.).
The recitation “(the mixer unit being) configured so that the diluent and the high concentration liquid fed from the feeder enter through the inflow part, the diluent and the high concentration liquid entering through the inflow part flow inside the internal space, and are mixed therein to produce a washing liquid with a constant concentration of the detergent component, and the washing liquid being produced by a flowing and mixing inside the internal space, exits through the outflow part according to an inflow entering through the inflow part.” is a capability of the mixer unit however taught in Figure 2 and citations above and below;
wherein the feeder is configured to intermittently feed the diluent and the high concentration liquid to the mixer unit,” (Para (53) and FIG 2. As a result of this merger of the sample and substrate streams, and referring now to FIG. 3 which depicts the incubation coil 78 in straight-line manner for purposes of illustration, it may be understood that a sample-substrate mixture stream S consisting of successive ones of said blood samples as mixed with said substrate, and as preceded and followed by air, wash liquid and air segments, respectively, will be flowed from the junction conduit 82 to and through the substrate and sample mixture incubation coil 78.)
Therefore, the diluent (first liquid) is that is intermittently feed is the sample-substrate mixture and the high concentration liquid (second liquid) that is feed into the feeder is the wash liquid. In addition, (Para (42) teaches secondary, sample-substrate mixture and color producing reagent supply, mixing and treatment means as indicated generally at 28 and which are operatively disposed as shown intermediate the incubation coil 78 and the colorimeter 124. Which then feeds to the “mixer unit” 108 discloses that the feeder is configured to intermittently feed the diluent to the mixer unit)
The recitation “the internal space has a volumetric capacity larger than a total amount of the diluent and the high concentration liquid fed by the feeder at one time,” is a capability of the internal space as its dependent on the amount of diluent and high concentration liquid fed into the feeder. Skeggs teaches the positively claimed structural elements of the internal space as claimed, such internal space is fully capable of the recited operation. Skeggs further teaches: (Paras (54 and 55), Assuming for example that each of said sample-substrate mixtures is divided or air-segmented into ten sample- substrate mixture volumes or slugs and that the total volume of a thusly air-segmented sample-substrate mixture is approximately 25% greater than the total volume of the incubation coil 78). Therefore, the total volume of all ten sample- substrate mixtures is 25% greater than the total volume compacity of the incubation coil (internal space of the mixer) so the internal space of the incubation coil would have a larger capacity than one of the ten sample-substrate mixture volumes which is what is feed into the incubation coil at one time. The volume from the incubation coil 78 feeds into the mixer unit 108 therefore the mixer unit would also have at least of not a larger volume compacity.
Further taught “the feeder comprises a first feeding pump configured to eject the diluent” (Para (34), proportioning pump 52, non-illustrated pump rollers to pump fluids therethrough. The outlet end of the sample offtake probe 40 is connected as indicated to the inlet end of the compressible pump tube 54. The inlet end of the compressible pump tube 56 extends as shown into a substrate container 62 to pump substrate from the latter.); Therefore, the first pump is pump 52.
Further taught “a second feeding pump configured to eject the high concentration liquid,” (Para (43), proportioning pump 84, non-illustrated pump rollers to pump fluids therethrough.).
“a first-liquid channel for the diluent to flow according to an ejection action of the first feeding pump,” (Para (53) and FIG. 1, compressible pump tube 56 for the substrate liquid within 62);
“a second-liquid channel for the high concentration liquid to flow according to an ejecting action of the second feeding pump,” (Para (44) and FIG. 2, compressible pump tube 88 extends as shown into a container 92 of a suitable color producing reagent);
“a three-way branch pipe for the dilutant from the first-liquid channel and the high concentration liquid from the second-liquid channel to flow together” (Fig. 2 three-way branch pipe 106);
“and a multi-liquid channel for the diluent and the high concentration liquid from the three-way branch pipe to mix and flow”, (Para (45) and Fig 2, junction conduit 106 where sample substrate stream from 86 (first liquid “diluent”) joins reagent stream from 88 (second liquid “high concentration liquid”);“the feeder is configured to feed the diluent and the high concentration liquid to the mixer unit via the multi-liquid channel” (Para (46) and Fig 2, mixing coil is indicated at 108 which the conduit 106 (multi-liquid channel) is fed into).
The recitation “(the second feeding pump) configured to eject the high concentration liquid while the first feeding pump ejects the diluent” is a capability of the feeding pump. Skeggs teaches the positively claimed structural elements of the feeding pumps as claimed, such feeding pumps are said to be fully capable of the recited operation.
Regarding claim 6, Skeggs teaches all of claim 1 as above in addition to “further comprising a reaction container configured to contain a sample and a reagent,” (Para (40) and Fig 2. , reaction rate detection means 30 in which the sample and reagent are within via 109); “and a nozzle” (Para (47), A conduit 109 is provided to connect the outlet of mixing coil 108 to the inlet of the colorimeter 124 for the flow of the suitably mixed and reacted, air-segmented sample-substrate-reagent stream to the latter. If required, dialyzer means (not shown) may of course be provided in the secondary circuit means 28.).
Therefore, the inlet within the reaction rate detection means is the nozzle.
The recitation “configured to discharge, according to each feeding operation of the feeder, said total amount of the washing liquid exiting through the outflow part, to the reaction container from which the sample and the reagent have been drained.” is a capability of the nozzle however taught within the inlet feeding the mixed and reacted, air-segmented sample-substrate-reagent stream.
Regarding claim 8, Skeggs teaches all of claim 1 as above. The recitation “wherein an amount of the high concentration liquid is smaller than an amount of the diluent among the diluent and the high concentration liquid fed by the feeder.” is a capability of the feeder. Skeggs discloses the positively claimed structural elements of the feeder as claimed, such feeder is said to be fully capable of the recited operation.
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 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Skeggs (US 3699004 A) as applied to claim 1, and further in view of Choe (US 7452726 B2).
Regarding claim 4 Skeggs teaches all of claim 1 as above but does not teach “wherein a cross-sectional area of the internal space, which is normal to a central axis of a channel in the inflow part for the diluent and the high concentration liquid to flow, is larger than a cross-sectional area of the multi-liquid channel.”.
The claims require the cross- are of the internal space of the mixer to be larger than the cross-section area of the multi-liquid channel.
Skeggs does not explicitly teach these cross-sections.
However, Choe does teach systems, including apparatus, methods, and kits, for the microfluidic manipulation and/or analysis of particles, such as cells, viruses, organelles, beads, and/or vesicles. Chloe also teaches passages having any suitable dimensions including width and cross-sectional profile. Channels and passages may be described according to function such as direction of flow, relationship to a particular reference structure and/or type of material carried with paras [134-135].
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the invention of Skeggs by having the cross-section of the internal space of the mixer larger than the cross-section of the multi-liquid channel, since Choe teaches passages having any cross-sections and they are based on function. It would be within the function of the internal space of the mixer to have a larger cross-section to allow space for the turbulent interaction of the fluids in the mixer.
Regarding claim 10, Skeggs and Chloe teach all of claim 8 as stated above, however does not explicitly teach “wherein the high concentration liquid is an alkaline or acidic liquid.” It is noted however, that applicant claims an apparatus. The fluid flowing through the apparatus is considered material worked upon and is not given patentable weight in claims to an apparatus. Even so, the use of an alkaline liquid in a mixing system would have been obvious for the reasons set forth below.
Choe teaches “wherein the second liquid is an alkaline or acidic liquid.” (Para [231] Reagents may be detection/assay reagents. Detection/assay reagents may include dyes, enzymes, substrates, cofactors, and/or SBP members (see Table 1 of Section VI above), among others. Such dyes may be conjugated to, or may be, SBP members; may act as enzyme substrates; may inherently label cells or cell structures (e.g., DNA dyes, membrane dyes, trafficking dyes, etc.); may act as indicator dyes (such as calcium indicators, pH indicators, etc.); and/or the like. Enzymes may operate in particle assays by incorporating dyes into products and/or by producing a product that may be detected subsequently with dyes, among others. Suitable enzymes may include phosphatases (such as alkaline phosphatase), nucleic acids, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skeggs to incorporate the teachings of Choe wherein the wherein the second liquid is an alkaline or acidic liquid. Doing so would allow the apparatus to be capable of a multitude of functions in which an alkaline or acid would further the analysis process.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Skeggs (US 3699004 A) as applied to claim 1 and further in view of Burns (US 4826775 A).
Regarding claim 5, Skeggs teaches all of claim 1 as stated above but does not explicitly teach “wherein a cross-sectional area of an opening at an end of a channel in the inflow part, from which the diluent and the high concentration liquid flow into the internal space, is smaller than a cross-sectional area of the multi-liquid channel.”
Burns teaches an automatic dilution apparatus and method which are operable in conjunction with automated sample liquid analysis systems. Burns further teaches “wherein a cross-sectional area of an opening at an end of a channel in the inflow part, from which the first liquid and the second liquid flow into the internal space, is smaller than a cross-sectional area of the multi-liquid channel.”. (Para (21), The dilution factor is readily determined and controlled by proper selection of the internal diameters, and thus of the internal cross-sectional areas, of the conduits 64 and 80 which each form a compressible pump tube as described. For example, if the internal diameter, and thus internal cross-sectional area, of conduit 64 is selected, in accordance with the other controlling operational parameters of the compressible tube pump 42 and the analysis system 10 as a whole, to aspirate and pump sample liquids from sampler 12 at 0.2 mL/min., and the internal diameter, and thus internal cross-sectional area, of conduit 80 selected as above to pump diluent from diluent source 78 at 1.8 mL/min., the total liquid flow supplied to analysis apparatus 14 will, of course, be 2.0 mL/min., of which only 10% will be sample liquid. Thus, a dilution factor of precisely 10 is provided; and it will be clear to those skilled in this art that this dilution factor may be readily and effectively changed, within a very wide range of realistic dilution factors and without any sacrifice in dilution factor precision, by simple change is the internal diameter, and thus internal cross-sectional area, of conduit 80.)
Therefore, since the liquid sample flow based on the internal diameter of one liquid is 0.2 mL/min and the second is 1.8 mL/min, then the total liquid flow is 2.0mL/min. This teaches that the diameter (cross-section) of the opening end of where the first and second fluid flow is smaller than the cross-section of the channel which is the multi-liquid channel as the total liquid flow is 2.0mL/min based on the diameter in which it flows.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skeggs to incorporate the teachings of Burns wherein a cross-sectional area of an opening at an end of a channel in the inflow part is smaller than a cross-sectional area of the multi-liquid channel. Doing so would allow the flow of the liquids within the apparatus to run more smoothly. Having an apparatus in which the cross-section area for the channel that multi-liquid flows through being larger than the opening of a channel for one liquid would allow for increased fluid flow.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Skeggs (US 3699004 A) as applied to claim 1 and further in view of Okamoto et. al. (JP 2014174112 A), machine translation.
Regarding claim 7, Skeggs teaches all of claim 1 as stated above in addition to “further comprising a probe configured to aspirate and discharge a sample or a reagent,” (Paras (33) and (50), A sample offtake device is indicated at 38 and comprises a sample offtake probe 40. While the latter is in turn intermittently operated to immerse the inlet end of said probe in a thusly presented sample container for a predetermined period of time to aspirate). However, Skeggs does not teach “and a tub configured to pool the washing liquid exiting through the outflow part, according to each feeding operation of the feeder, wherein the probe is configured to aspirate the diluent and the high concentration liquid pooled in the tub, before aspirating the sample or the reagent or after discharging the sample or the reagent.”
Okamoto teaches an automatic analyzer has a dispensing probe that dispenses a sample and a reagent, a reaction container that contains a sample and a reagent dispensed by the dispensing probe in addition to “a tub” and “the probe” (Pages 1 and 3, The automatic analyzer has a dispensing probe that dispenses a sample and a reagent, a reaction container that contains a sample and a reagent dispensed by the dispensing probe. the sample dispensing probe 17 for dispensing a sample such as a standard sample or a test sample in the sample container 402 held by the sample rack 401 conveyed by the conveying unit 400 and sucking the sample into the reaction container 15. And a sample dispensing arm 18 that holds the sample dispensing probe 17 so as to be able to rotate and move up and down. In addition, a first reagent dispensing probe 19 for aspirating the first reagent in the reagent container 11 held in the first reagent rack 12 and dispensing it into the reaction container 15 from which the sample has been discharged; A first reagent dispensing arm 20 that holds the reagent dispensing probe 19 so as to be capable of rotating and vertically moving is provided.).
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 Skeggs to incorporate the teachings of Okamoto wherein the apparatus has a tub and a probe which transfers liquid. Doing so would allow that apparatus to transfer liquids from one location to another in addition to storing the liquids prior to additional transfer or movement.
The recitation “configured to pool the washing liquid exiting through the outflow part, according to each feeding operation of the feeder, wherein the probe is configured to aspirate the diluent and the high concentration liquid pooled in the tub, before aspirating the sample or the reagent or after discharging the sample or the reagent.” is a capability of the tub and the probe. Skeggs and Okamoto disclose the positively claimed structural elements of the tub and the probe as claimed, such tub and probe are said to be fully capable of the recited adaptation in as much as recited and required herein.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Skeggs (US 3699004 A) in view of Wakui et. al. (CN 103210297 A),Robaato et. al. (JP H05149958 A) and Khine et. al. (US952282 B2)
Regarding claim 11 Skeggs teaches “An automatic analyzing apparatus,” (Para (3), New and improved method and apparatus for the fully automatic, highly accurate quantitative analysis of a series of samples with regard to a constituent thereof on a continuous flow basis through rate reaction determination are provided and are operable through the continuous mixing of said samples.);
“comprising: a feeder configured to feed a diluent and a high concentration liquid,” (Paras (32-34) and Fig 1, The fluid sample and substrate supply means 22 comprising turntable 34 upon which is disposed a generally circular array of blood sample containers 36. In which the outlet end of the sample offtake probe 40 is connected as indicated to the inlet end of the compressible pump tube 54, while the inlet end of the compressible pump tube 56 extends as shown into a substrate container 62 to pump substrate from the latter. The pump 52 which has the pump tubes connected to the probe for the sample and the substrate.) Therefore, the pump is the feeder that is configured to feed liquids. The recitation “diluent” and “high concentration liquid” in addition to
“the high concentration liquid including a concentration of a detergent component that provides a higher detergency than the diluent;” is a capability of the feeder. Skeggs teaches the positively claimed structural elements of the feeder as claimed, such feeder is said to be fully capable of the recited operation. The fluid flowing through the apparatus is considered material worked upon and is not given patentable weight in claims to an apparatus.
Further taught “and a mixer unit comprising an inflow part, and internal space, and an outflow part,”
(Para (46) and Fig 2, mixing coil is indicated at 108 which the conduit 106 is fed into. The inflow part is the side closest to 106, the outflow part is the part closest to 109 and the internal space is the coil part.).
The recitation “(the mixer unit being) configured so that the diluent and the high concentration liquid fed from the feeder enter through the inflow part, the diluent and the high concentration liquid entering through the inflow part flow inside the internal space, and are mixed therein to produce a washing liquid with a constant concentration of the detergent component, and the washing liquid produced by a flowing and mixing process inside the internal space exit through the outflow part according to an inflow entering through the inflow part,” is a capability of the mixer unit however taught in Figure 2 and citations above and below.
Skeggs does not teach “wherein the internal space has a shape in which surfaces of a cuboid that cross at right angles are rounded.”
Wakui teaches “wherein the internal space has a shape in which surfaces of a cuboid” (Para [0017], [0017] The reaction vessel is cuboid or cylindrical and includes from the light source of the light with respect to the light of from the light source incident on the surface of the reaction container of the reaction container to form a specified angle are incident on the optical system of the reaction vessel.) [0018], the reaction vessel is a four-corner shape, generally, the light incident from the right angle direction relatively to the light source light incident surface of the reaction vessel.
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 Skeggs to incorporate the teachings of Wakui wherein the internal space of the mixer with a shape is cuboid. Doing so decreases the time in which it takes the liquids to become homogenized and minimizes the amount of dead zone that would occur if the entire internal space was circular.
Skeggs teaches the angles are rounded (see Fig. 2) rather than cross at right angles.
However, Robaato teaches the internal space of the mixer “that cross at right angles” (Page 14, The capillary channels have both dimensions at right angles to the direction of flow to the extent needed to support the flow. The capillary chamber does not support the capillary flow but has one dimension at right angles to the flow that provides the capillary flow by having a second dimension at right angles to the flow to the extent required (Similar to the space between two adjacent flat plates).
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 Skeggs to incorporate the teachings of Robaato wherein the internal space of the mixer cross at right angles. Doing so allows for fast redirection of fluids which increases the mixing rate per Khine. Having then cross at right angles is a complex passive design as it uses a specific geometry set up. Khine teaches preparing microfluidic channels in addition to passive designs provide rapid and effective mixing in complex passive design (col. 16 lines 35-61).
Response to Arguments
Applicant's arguments filed 5/11/2026 have been fully considered but are not persuasive.
Applicant argues the cited art teaches “the pump 84 and the mixing coil 108 are arranged downstream of the pump 52 and the mixing and treatment means 26 via conduits 96 and 98” and “the second feeding pump would be positioned between two different mixers (mixing treatment means 26 and mixing coil 108)”.
Examiner has clarified which part of Skeggs is mapped to the claimed mixing unit.
Applicant argues that in regard to claim 11 the cited references fail to teach “internal space of the mixer unit has a shape in which surfaces of a cuboid that cross at right angles are rounded” and does not disclose “ the internal space of the mixer unit, which includes an inflow part, the internal space, and outflow part, has a shape in which surfaces of a cuboid that cross at right angles are rounded”.
Examiner respectfully disagrees and points to Wakui for the cuboid surface, Skeggs for rounded angles, and Robaato for right angles that cross, respectively. Although Wakui teaches the reaction vessel is cuboid ,the reaction vessel of Wakui teaches to the mixing unit of Skeggs since Wakui’s reaction container mixes the sample with the reagent (para [0038]) as does the mixing unit of Skeggs.
Applicant argues the regards to claim 7 the recited art does not teach “a tube configured to pool the washing liquid exiting through the outflow part”.
Examiner respectfully disagrees in that the cited reference teaches the rub and the configured to pool the washing liquid exiting through the outflow part is capability of the tub. The tub is capable of pooling a liquid and therefore able to perform as recited.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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