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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/9/2023, 11/28/2023, and 3/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group III and group IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/15/2026.
Applicant's election with traverse of group I and group II in the reply filed on 9/15/2026 is acknowledged. The traversal is on the ground(s) that the Applicant amended claim 12 to positively recite the microfluidic device and incorporate the limitations of claim 1 into the step of providing such a microfluidic device. This is not found persuasive because the groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Group I and II lack unity of invention because even though the inventions of these groups require the technical feature of a microfluidic device for analyzing sample material, comprising: a microfluidic network including a first network portion configured to purify a sample material, and a second network portion configured to amplify the sample material, wherein the second network portion is connected to the first network portion via a connection duct, and the first and second network portions are configured to be separable from one another, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view Tagawa et al (US 20180221878 A1; hereinafter “Tagawa”). Tagawa teaches a microfluidic device for analyzing sample material (Tagawa; Abstract), comprising: a microfluidic network including a first network portion configured to purify a sample material (Tagawa; para [364, 364]; the magnetic particles are mixed with a reagent containing a marking substance in the fluid module 200A), and a second network portion configured to amplify the sample material (Tagawa; para [374]; a fluid module 200C for PCR amplification), wherein the second network portion is connected to the first network portion via a connection duct (Tagawa; Fig. 16), and the first and second network portions are configured to be separable from one another (Tagawa; para [96]; The connection flow channel 350 may be provided separately from the first fluid module 250 and the second fluid module 260, and may be a flow channel that connects the first fluid module 250 and the second fluid module 260). The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-15 are pending with claims 1-11 being examined and claims 12-15 are withdrawn.
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.
Claim 8 is 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.
Claim 8 recites the limitation "wherein at least one of the first shutoff valve and the second shutoff valve are controlled by the valve control connection" in lines 3-4. The limitation is unclear as to whether the limitation requires both the first and second shutoff valve or only one first shutoff valve or one second shutoff valve. Specifically, claim 8 is dependent on claim 7 which recites “the first network comprises a first shut off valve…and/or the first second functional module of the second network portion comprises a second shutoff valve”. Therefore, it is unclear if Applicant intends to comprise both shutoff valves or a single shutoff valve. For purpose of prosecution, the Examiner interprets the claim to require a single shutoff valve to the respective network portion.
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 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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tagawa et al (US 20180221878 A1; hereinafter “Tagawa”).
Regarding claim 1, Tagawa teaches a microfluidic device for analyzing sample material (Tagawa; Abstract), comprising: a microfluidic network including a first network portion configured to purify a sample material (Tagawa; para [364, 364]; the magnetic particles are mixed with a reagent containing a marking substance in the fluid module 200A), and a second network portion configured to amplify the sample material (Tagawa; para [374]; a fluid module 200C for PCR amplification), wherein the second network portion is connected to the first network portion via a connection duct (Tagawa; Fig. 16), and the first and second network portions are configured to be separable from one another (Tagawa; para [96]; The connection flow channel 350 may be provided separately from the first fluid module 250 and the second fluid module 260, and may be a flow channel that connects the first fluid module 250 and the second fluid module 260).
Regarding claim 2, Tagawa teaches the microfluidic device according to claim 1, wherein the first network portion and the second network portion are arranged in a linear topology (Tagawa; Fig. 41).
Regarding claim 3, Tagawa teaches the micro fluidic device according to claim 1, wherein the first network portion and/or the second network portion comprises a plurality of fluidically separable functional modules (Tagawa; Fig. 16; One (first fluid module 250) of the fluid modules 210 adjacent to each other on the substrate 300 is connected to the other of the fluid modules 210 (the second fluid module 260) through the corresponding substrate flow channel 310 and flow channel 221 of the connection module 220). The Examiner interprets the plurality of connection modules as the plurality of fluidically separable functional modules.
Regarding claim 4, Tagawa teaches the microfluidic device according to claim 3, wherein: the device comprises a control connection for applying pressure; and the control connection is connected via a first control duct to an element of a functional module of the first network portion and via a second control duct to an element of the functional module of the second network portion (Tagawa; para [105]; The first fluid module 250 and the second fluid module 260 are configured so as to respectively feed liquid through the first flow channel 251 and the second flow channel 261 by using pressure supplied from the specimen treatment apparatus 500 through the port 110 for injecting a specimen).
Regarding claim 5, Tagawa teaches the microfluidic device according to claim 1, wherein: the first network portion comprises a first first network functional module for providing liquid reagents, and/or a second first network functional module for adding the sample material, and/or a third first network functional module for filtering the sample material, and/or a fourth first network functional module for storing a liquid and/or a pump module for establishing a fluid transport between the functional modules; and/or the second network portion comprises at least a first second network functional module for amplifying the sample material and/or a second second network functional module for releasing at least one amplification reaction bead (Tagawa; para [138]; The specimen treatment apparatus 500 injects liquid into the specimen treatment chip 100 and recovers liquid from the specimen treatment chip 100 through the connector 400 by using the pump 521). The specimen treatment apparatus is interpreted as the fourth first network module. The Examiner notes that the “the second network portion compris[ing]…” is not required as the Applicant recites “and/or”.
Regarding claim 6, Tagawa teaches the microfluidic device according to claim 5, wherein: the first network portion includes the fourth first network functional module (Tagawa; Fig. 18, 19; para [138]; The specimen treatment apparatus 500 injects liquid into the specimen treatment chip 100 and recovers liquid from the specimen treatment chip 100 through the connector 400 by using the pump 521); the second network portion includes the first second network functional module (Tagawa; para [263, 264]; a fluid module 200C for PCR amplification); and the fourth first network functional module of the first network portion and the first second network functional module of the second network portion are fluidically connected via the connection duct (Tagawa; Fig. 18, 19). The Examiner notes modules are connected by the connection modules as depicted in Fig. 18.
Regarding claim 7, Tagawa teaches the microfluidic device according to claim 6, wherein the fourth first network functional module of the first network portion comprises a first shutoff valve configured to close the connection duct, and/or the first second network functional module of the second network portion comprises a second shutoff valve configured to close the connection duct (Tagawa; para [137]; a valve 522 that opens and closes a supply path of pressure to the liquid).
Regarding claim 8, Tagawa teaches the microfluidic device according to claim 7, further comprising: a valve control connection for applying pressure, wherein at least one of the first shutoff valve and the second shutoff valve are controlled by the valve control connection (Tagawa; para [142]; In the configuration of Fig. 19, the flow rate sensor 525 detects a flow rate (e.g., a unit is µL/min) of liquid flowing through the liquid feeding pipe 526. The flow rate sensor 525 feeds back a detection result of the flow rate to the pump 521. The pump 521 controls pressure in response to feedback from the flow rate sensor 525).
Regarding claim 9, Tagawa teaches the microfluidic device according to claim 5, wherein: the first network portion includes the fourth first network functional module; and the fourth first network functional module of the first network portion is designed to output a liquid with the sample material (Tagawa; para [137]; The liquid feeder 520 further includes a liquid reservoir 523 for containing liquid to be injected into the specimen treatment chip 100).
Regarding claim 10, Tagawa teaches the microfluidic device according to claim 5, wherein the first network portion comprises an additional second functional module configured to add the sample (Tagawa; Fig. 19; para [139]; a plurality of liquid reservoirs 523).
Regarding claim 11, Tagawa teaches the microfluidic device according to claim 4, wherein: the device comprises at least one further control connection for applying pressure, and the further control connection is connected via a further control duct to either an element of a functional module of the first network portion or to an element of a functional module of the second network portion (Tagawa; para [137, 138]; a valve 522 that opens and closes a supply path of pressure to the liquid…the specimen treatment chip 100 through the connector 400 by using the pump 521, the liquid reservoir 523, and the valve 522).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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