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 Invention I, Species I, claims 1-9, 11, and 12, in the reply filed on 5/15/2026 is acknowledged.
Claims 10 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/31/2023 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 4 and 5 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.
Regarding claim 4, the limitation “a dilution valve for diluting the particle suspension on the downstream side” renders the claim indefinite. Numerous conflicting interpretations are within purview of one of ordinary skill in the art. It is unclear if the dilution valve is on the downstream side or if the intended use of diluting of the particle suspension happens on the downstream side.
Further, it is unclear if “the downstream” in line 8 refers to “a downstream side of a most downstream branch point” (claim 4), “a downstream side of the branch flow path” (claim 3, lines 6-7), or “a downstream side of the main flow path” (claim 3, lines 10-11).
Even further, it is unclear if the limitation “processing circuitry” in line 12 is the same or different as the processing circuitry recited in claim 1. For examination on the merits, the processing circuitry of claim 4 will be interpreted as the same as that of claim 1. If Applicant intended processing circuitry of claim 4 to be the same as processing circuitry of claim 1, Examiner suggests to amend claim 4 such that “processing circuitry” reads “the processing circuitry”.
Claim 5 is similarly rejected as it depends upon rejected claim 4.
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 1-5, 7, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zantl et al. (US 2021/0269761 A1) (hereinafter referred to as Zantl, see PTO-892).
Regarding claim 1, Zantl discloses a density adjusting apparatus (abstract, fluid channel system, “concentrating…and/or diluting a cell suspension”) comprising:
a flow path structure (Fig. 7, system 11c) including a main flow path (Fig. 7, conduit 19) into which a particle suspension flows ([0134] discloses that 12a contains a cell suspension; [0136], “The conduit may be connected to the culturing access 5a of the first culturing channel via valve 15a, to the transfer access 7a of the transfer channel”) and at least one branch flow path that branches from the main flow path (Fig. 7 shows at least one branch flow path that branches from the main flow path – see annotated figure below) and
is provided with a concentration valve related to concentrating the particle suspension ([0167] any one of valves 15a, 16a, or 18b are related to concentrating a cell suspension, i.e., particle suspension); and
processing circuitry (claim 19, controller; [0052] discloses structure for a measurement device) configured to obtain density information indicating a density of particles contained in the particle suspension and goal information indicating a goal density of the particles contained in output liquid caused to flow out of the main flow path and configured to control opening and closing of the concentration valve on a basis of the density information and the goal information (claim 19, “controller…being configured to regulate values of parameters to be set on the active components…on the basis of target values and measured actual values of process measurands which are detected by the measurement device”; [0024], active elements are valves).
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The limitations “configured to obtain density information indicating a density of particles contained in the particle suspension and goal information indicating a goal density of the particles contained in the output liquid caused to flow out of the main flow path” and “configured to control opening and closing of the concentration valve on a basis of the density information and the goal information” are directed toward the intended manner of operating the claimed processing circuitry and does not differentiate the claimed processing circuitry from the prior art processing circuitry because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art processing circuitry would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 2, the claim is directed toward the intended manner of operating the claimed processing circuitry and does not differentiate the claimed processing circuitry from the prior art processing circuitry because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art processing circuitry set forth above would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 3, Zantl discloses the density adjusting apparatus according to claim 1, further comprising:
a pump that is provided on an upstream side of the main flow path (Fig. 7, pump 13a – see figure below) and is configured to cause the particle suspension to flow into the main flow path ([0147], “liquid is transported from the storage container 12a into the first culturing channel using the pump 13a…to enter the conduit 19”);
a transit liquid collecting (Fig. 7, 12d waste container) and is configured to collect transit liquid having transited through the branch flow path; and
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an output liquid collecting (Fig. 7, storage channels 3a) and is configured to collect the output liquid having the goal density ([0167]-[0168], storage channel collects cells during concentration or dilution; end concentration, i.e., goal density, can be adjusted as discussed above).
Regarding the limitations wherein the transit liquid collecting tank is provided on a downstream side of the branch flow path and the output liquid collecting tank is provided on a downstream side of the main flow path, Zantl teaches that the flow direction can be controlled ([0040]) and describes instances where each limitation as written is met ([0167] and [0168] describes how fluid flows through the apparatus). Therefore, the apparatus of Zantl meets the limitations as claimed.
The limitation “is configured to cause the particle suspension to flow into the main flow path” is directed toward the intended manner of operating the claimed pump and does not differentiate the claimed pump from the prior art pump because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art pump would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “is configured to collect transit liquid having transited through the branch flow path” is directed toward the intended manner of operating the claimed transit liquid collecting tank and does not differentiate the claimed transit liquid collecting tank from the prior art transit liquid collecting tank because all structural limitations are taught in the prior art (MPEP § 2114 II). The transit liquid collecting tank taught by Zantl would be fully capable of achieving every claimed intended use because the waste container can receive fluid from multiple branch flow paths ([0167] and [0168]).
The limitation “is configured to collect the output liquid having the goal density” is directed toward the intended manner of operating the claimed output liquid tank and does not differentiate the claimed output liquid tank from the prior art output liquid tank because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art output liquid tank would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
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Regarding claim 4, Zantl discloses the density adjusting apparatus according to claim 3, wherein the flow path structure further includes a merging flow path (Fig. 7, channel 2c – see annotated figure below) that merges with the main flow path on a downstream side of a most downstream branch point among branch points between the main flow path and the branch flow path (Fig. 7) and that is provided with a dilution valve (Fig. 7, valve 15c) for diluting the particle suspension on the downstream side, the output liquid collecting tank (Fig. 7, storage channel 3a) is provided on a downstream side of a merging point between the merging flow path and the main flow path (Fig. 7), and processing circuitry (set forth above) is configured to control opening and closing of the dilution valve, on the basis of the density information and the goal information.
The limitation “for diluting the particle suspension on the downstream side” is directed toward the intended manner of operating the claimed dilution valve and does not differentiate the claimed dilution valve from the prior art dilution valve because all structural limitations are taught in the prior art (MPEP § 2114 II). The dilution valve taught by Zantl would be fully capable of achieving every claimed intended use because the prior art dilution valve can supply liquid (claim 16).
The limitation “configured to control opening and closing of the dilution valve, on the basis of the density information and the goal information” is directed toward the intended manner of operating the claimed processing circuitry and does not differentiate the claimed processing circuitry from the prior art processing circuitry because all structural limitations are taught in the prior art (MPEP § 2114 II). The processing circuitry taught by Zantl would be fully capable of achieving every claimed intended use because the prior art processing circuitry can control valves using target and measured values (claim 19, “controller…being configured to regulate values of parameters to be set on the active components…on the basis of target values and measured actual values of process measurands which are detected by the measurement device”; [0024], active elements are valves).
Regarding claim 5, Zantl discloses the density adjusting apparatus according to claim 4, further comprising: a diluted particle suspension input unit ([0168]; Fig. 7, storage container 12b) that is provided on an upstream side of the merging flow path (Fig. 7, storage container 12b is upstream of merging flow path) and is configured to cause diluted liquid having a lower density than the particle suspension to flow into the merging flow path.
The limitation “is configured to cause diluted liquid having a lower density than the particle suspension to flow into the merging flow path” is directed toward the intended manner of operating the claimed diluted particle suspension unit and does not differentiate the claimed diluted particle suspension unit from the prior art diluted particle suspension unit because all structural limitations are taught in the prior art (MPEP § 2114 II). The diluted particle suspension unit taught by Zantl would be fully capable of achieving every claimed intended use because it can provide cell culture medium through the storage channel and transfer channel ([0168]).
Regarding claim 7, Zantl discloses the density adjusting apparatus according to claim 1, wherein the concentration valve is structured with a material and a mechanism that enable opening and closing thereof ([0027] and [0028]), according to a control signal output from the processing circuitry (claim 19; [0024]).
Regarding claim 11, Zantl discloses the density adjusting apparatus according to claim 1, wherein the flow path structure further includes:
an extra main flow path different from the main flow path (Fig. 7 – see annotated figure below);
at least one extra branch flow path that branches from the extra main flow path and is provided with an extra concentration valve (Fig. 7); and
a merging part where the main flow path merges with the extra main flow path, on a downstream side of a most downstream branch point among branch points between the main flow path and the branch flow path (Fig. 7).
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The limitations “is configured to obtain extra density information indicating a density of other particles contained in another liquid caused to flow into the extra main flow path and extra goal information indicating a goal density of the other particles contained in another output liquid caused to flow out of the extra main flow path” and “is configured to control opening and closing of the extra concentration valve, on a basis of the extra density information and the extra goal information” is directed toward the intended manner of operating the claimed processing circuitry and does not differentiate the claimed processing circuitry from the prior art processing circuitry because all structural limitations are taught in the prior art (MPEP § 2114 II). The processing circuitry taught by Zantl would be fully capable of achieving every claimed intended use because the prior art processing circuitry can control valves using measured and target values (claim 19, “controller…being configured to regulate values of parameters to be set on the active components…on the basis of target values and measured actual values of process measurands which are detected by the measurement device”; [0024], active elements are valves)
Regarding claim 12, the claim is directed toward the intended manner of operating the claimed processing circuitry and does not differentiate the claimed processing circuitry from the prior art processing circuitry because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art processing circuitry would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zantl in view of Goffe et al. (US Patent 5,240,856) (hereinafter referred to as Goffe, see PTO-892).
Regarding claim 6, Zantl discloses the density adjusting apparatus according to claim 1, further comprising: a sensor (claim 18, measurement device) configured to measure a density of the particles on an upstream side of a most upstream branch point among branch points between the main flow path and the branch flow path.
Zantl does not disclose or teach an input interface.
However, Goffe in the art of cell separation teaches a user interface for providing information to (claim 31, “a user interface for providing information to”; col. 6, lines 56-59). The user interface connected to a microprocessor, which controls the operation of the cell separator (col. 6, lines 54-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Zantl to incorporate the user interface of Goffe, i.e., an input interface, because it would predictably allow a user to input information to control the apparatus.
The limitation “configured to measure a density of the particles on an upstream side of a most upstream branch point among branch points between the main flow path and the branch flow path” is directed toward the intended manner of operating the claimed sensor and does not differentiate the claimed sensor from the prior art sensor because all structural limitations are taught in the prior art (MPEP § 2114 II). The sensor taught by Zantl would be fully capable of achieving every claimed intended use because the prior art sensor can measure density ([0049], optical inspection measures density; claim 18, measurement device configured to optically inspect).
The limitation “configured to receive an input of the goal information” is directed toward the intended manner of operating the claimed input interface and does not differentiate the claimed input interface from the prior art input interface because all structural limitations are taught in the prior art (MPEP § 2114 II). The input interface taught by Goffe would be fully capable of achieving every claimed intended use because the prior art input interface can receive a user input (col. 6, lines 59-62).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zantl in view of Yi, Y., Huang, R. & Li, C. Flexible substrate-based thermo-responsive valve applied in electromagnetically powered drug delivery system. J Mater Sci 54, 3392–3402 (2019) (hereinafter referred to as Yi, see PTO-892).
Regarding claim 8, Zantl discloses the density adjusting apparatus according to claim 7.
Zantl does not teach or disclose wherein the material is a thermoresponsive polymer.
However, Yi in the art of microfluidics teaches it is known in the art to form valves using PNIPAM (abstract). Yi teaches that PNIPAM hydrogel is temperature sensitive and is actuated by heat (pg. 3393, col. 2, lines 22-26; pgs. 3395-3396 PNIPAM hydrogel valve section). Yi further teaches that PNIPAM hydrogel offers cost, operation, and fabrication advantages compared to other valve materials (pg. 3393, col. 2, lines 22-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the concentration valve of Zantl with PNIPAM, i.e., a thermoresponsive polymer, as it provides cost, operation, and fabrication advantages over other valve materials, as taught by Yi.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zantl and Yi as applied to claim 8 above, and as evidenced by Emaminejad et al. (US 2021/0022651 A1) (hereinafter referred to as Emaminejad, see PTO-892).
Regarding claim 9, the prior art combination teaches the density adjusting apparatus according to claim 8.
The prior art combination is silent to a thin film electrode attached to the thermoresponsive polymer, as the mechanism, and the processing circuitry is configured to apply voltage to the thin film electrode, as the control signal.
However, Yi of the prior art combination teaches that the mechanism for actuating a PNIPAM hydrogel valve is embedded ferromagnetic particles to generate heat (pg. 3393, col. 2, lines 22-26).
Additionally, Emaminejad in the art of microfluidics provides evidence that electrodes can be used to heat PNIPAM valves ([0018], “The PNIPAM-valve is opened by activating the heater electrode”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the prior art combination mechanism of embedded ferromagnetic particles with a thin film electrode would also heat the thermoresponsive polymer, thus actuating the concentration valve formed from the thermoresponsive polymer. It has been held that it is prima facie obvious to substitute equivalents known for the same purpose (MPEP § 2144.06).
Although the prior art combination is silent to the thin film electrode is attached to the thermoresponsive polymer, modifying the prior art combination apparatus such that would amount to merely rearrangement of parts, as such a modification would predictably result in heat the thermoresponsive polymer.
The limitation “is configured to apply voltage to the thin film electrode, as the control signal” is directed toward the intended manner of operating the claimed processing circuitry and does not differentiate the claimed processing circuitry from the prior art processing circuitry because all structural limitations are taught in the prior art (MPEP § 2114 II). The processing circuitry taught by Zantl of the prior art combination would be fully capable of achieving every claimed intended use because the prior art processing circuitry is capable of controlling active components (Zantl, claim 19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shimase et al. (US 2017/0159003 A1) discloses a cell concentration adjustment device.
Yoneta (US 2022/0146400 A1) discloses a particle separating and measuring device.
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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799
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