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 1-18, in the reply filed on 09/15/2025 is acknowledged. The traversal is on the ground(s) that the exemplary process suggested does not represent a “materially different” method of using Applicant’s product and therefore does not meet the criteria for distinctness, and that it would appear that a search and examination of the entire application can be conducted without a serious burden. This is not found persuasive because the materially different method is that invention I can be used in a method without scanning.
Additionally, with respect to arguments directed to there is no serious burden this is not found persuasive because the issue as to the meaning and intent regarding “independent and distinct” as used in 35 U.S.C 121 and 37 CFR 1.41 has been adequately addressed in MPEP §802.01. Therein, it is stated that the legislative intent was to maintain the substantive law on the subject of restriction practice prior to enactment of 35 USC 121. Such practice permitted restriction between distinct, albeit dependent inventions. If the intent had been otherwise, then only the term “independent” would have been used. Thus, restriction between the distinct inventions set forth in this application is proper even though these inventions are clearly related.
With regard to applicants allegation that joinder of these distinct inventions would not present a serious burden to the U. S. Patent and Trademark Office, such allegations relied on the unsupported assumption that the search and the examination of both the invention would be coextensive. Invention I would require a search in B01L2300/0825 with a unique text search, and invention II would require a search in G01N21/78 with a unique text search different from the one used for group I as set forth at the top of page 3 of the 8-26-2025 Office Action.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/15/2025.
Status of Claims
Claims 1-20 remain pending in the application, with claims 1-18 being examined and claims 19-20 being withdrawn pursuant to the election filed 09/15/2025.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 01/22/2022. It is noted, however, that applicant has not filed a certified copy of the CN2022210075783.4 application as required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
[0003] has CN112362648A and CN112505027A, which have not been considered unless they appear in the PTO-892.
Specification
The disclosure is objected to because of the following informalities:
In [0086] it describes where a reagent block 3 “comprise a reaction part 32 and a waste liquid absorption part 31, where the reaction part 32 is configured to implement a color reaction, and the waste liquid absorption part 31 is configured to adsorb excess liquid samples, reagents, or waste liquid in a color reaction process.” It is understood that absorption and adsorption are two different things, where it is confusing as to how an absorption part will be adsorbing excess liquid.
Please note that absorbing and adsorbing are described elsewhere in the specification, and should be changed accordingly if necessary.
Appropriate correction is required.
Claim Objections
Claims 1, 6 are objected to because of the following informalities:
Claim 1 recites “for multiple indicator detection of micro sample” on lines 1-2, where it sounds as though there is a word or phrase missing.
Claim 6 recites “comprises a first interface configure to connect a syringe” where it is suggested to amend the claim to be “configured to connect a syringe”.
Appropriate correction is required.
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 1-18 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.
Claim 1 recites “a substrate configured to carry the microfluidic detection strip chip” on line 3, where it is unclear how the substrate will carry the microfluidic detection strip chip, as lines 1-2 describe “A microfluidic strip chip for multiple indicator detection of micro sample, including:”. In other words, lines 1-2 sets forth what the microfluidic detection strip chip includes, but then line 3 describes that a substrate carries the microfluidic detection strip chip. How is a component that is part of the microfluidic detection strip chip also carrying the entirety of the microfluidic detection strip chip?
[0073] of the instant specification describes where the substrate 1 is a rectangular strip sheet configured to carry the microfluidic pipe 2 and reagent blocks 3 and is combined into a complete microfluidic detection strip chip.
For examination, it will be interpreted that the substrate will be configured to carry the microfluidic pipe and plurality of reagents which then forms the microfluidic detection strip chip.
Lines 5-6 recites “liquid sample or reagents” where it is unclear if the liquid sample is the same or different from the micro sample described on lines 1-2.
For examination, it will be interpreted that the liquid sample is the same as the micro sample.
Line 9 recites “the reagent block” where it is unclear which reagent block of the plurality of reagent blocks described on line 8 is being referred to. Additionally, as there are a plurality of reagent blocks are all of them in a single groove?
Claims 2-18 are rejected by virtue of being dependent on a rejected claim.
Claim 2 recites “configured to detect two different types of indicators.” on lines 2-3, where it is unclear if these indicators are the multiple indicator detection of micro sample described on lines 1-2 of claim 1.
Claims 3-12 are rejected by virtue of being dependent on a rejected claim.
Claim 3 recites “three or more independent pipeline systems” on line 2, where it is unclear if the independent pipeline systems of claim 3 are the same or different from the ones described in claim 2. Additionally, line 3 recites “types of indicators” where it is similarly unclear if the types of indicators are the same or different from those described in claim 2.
For examination, it will be interpreted that the three or more independent pipeline systems includes the two or more independent pipeline systems of claim 2, and that the three or more different types of indicators includes the two different types of indicators from claim 2.
Claims 4-12 are rejected by virtue of being dependent on a rejected claim.
Claim 4 recites “the capillary network and a substrate form a groove” on line 4, where it is unclear if the substrate and groove of claim 4 are the same or different from the substrate and groove described on lines 3-4 of claim 1.
For examination, it will be interpreted that the substrate and groove of claim 4 are the same as the ones described in claim 1.
Claims 5-12 are rejected by virtue of being dependent on a rejected claim.
Claim 5 recites “sample or reagents” on line 3, where it is unclear if the sample or reagents are the same or different from the sample or reagents described by line 8 of claim 1.
For examination it will be interpreted that they are the same sample or reagents.
Claims 6-10 are rejected by virtue of being dependent on a rejected claim.
Claim 6 recites “for filling sample.” on line 3, where it is unclear if this sample is the same or different from the liquid sample described on line 8 of claim 1.
For examination it will be interpreted that they are the same samples.
Claims 7-10 are rejected by virtue of being dependent on a rejected claim.
Claim 7 recites “a first port” on line 3, where it is unclear if this first port is the same or different from the first port described on line 2 of claim 4.
For examination it will be interpreted that they are the same first port.
Line 4 recites “filling sample” where it is unclear if this sample is the same or different from the liquid sample described on line 8 of claim 1.
For examination it will be interpreted that they are the same samples.
Claims 8-10 are rejected by virtue of being dependent on a rejected claim.
Claim 8 recites “configured to connect a syringe for adding reagents.” on line 4 where it is unclear if the reagents are the same or different from the reagents described on line 8 of claim 1.
For examination it will be interpreted that they are the same reagents.
Claims 9-1- are rejected by virtue of being dependent on a rejected claim.
Claim 9 recites “to store liquid sample or reagents” on lines 2-3, where it is unclear if these are the same or different from the liquid sample or reagents described on line 8 of claim 1.
For examination it will be interpreted that they are the same liquid sample or reagents.
Line 4 recites “into a capillary network through a first port.” where it is unclear if this capillary and first port are the same or different from the capillary network and first port described in claim 4.
For examination, it will be interpreted that they are the same capillary network and first port.
Claim 10 is rejected by virtue of being dependent on a rejected claim.
Claim 10 recites “a syringe needle” on line 3, where it is unclear if it could be referring to the syringe for filling sample described in claim 6, or if it is referring to a syringe for adding reagents, or both.
Line 4 recites “a first port”, where it is unclear if this first port is the same or different from the first port described in claim 4.
For examination, it will be interpreted that they are the same first port.
Claim 11 recites “a groove” on line 4, where it is unclear if this groove is the same or different from the groove described in claim 1.
Additionally, from the phrasing of claim 11 “to connect a groove close to a first port, and the last stage second port has a largest opening configured to connect the groove far from the first port.” on lines 3-5, it is unclear if the groove being referred to on line 5 is the same or different from the groove described on line 4. Are there two grooves, one close to the first port, and then a separate groove that is far from the first port? Or are they the same groove?
Line 4 recites “a first port” where it is unclear if this first port is the same or different from the first port described in claim 4.
For examination, it will be interpreted that they are the same first port.
Claim 12 recites “of liquid sample or reagents.” on line 3, where it is unclear if the liquid sample or reagents are the same or different from the ones described in claim 1.
For examination, it will be interpreted that they are the same liquid sample or reagents.
Claim 13 recites “a plurality of grooves is arranged in a lattice to accommodate a plurality of reagent blocks.” where it is unclear if the plurality of grooves is in addition to the groove described in claim 1 or not. Further, it is unclear if the plurality of reagent blocks are the same or different from the plurality of reagent blocks described in claim 1.
Additionally, is a single groove of the plurality of grooves accommodating a plurality of reagent blocks? Or is there one reagent block per groove?
Claims 14-18 are rejected by virtue of being dependent on a rejected claim.
Claim 14 recites “the reagent block” on lines 1-2, where it is unclear which reagent block is being referred to, as claim 13 describes a plurality of reagent blocks.
Line 2 recites “a chromogenic reaction” where it is unclear if this chromogenic reaction is the same or different from the chromogenic reaction described in claim 1.
For examination, it will be interpreted that they are the same chromogenic reactions.
Line 3 recites “a sample and a reagent” where it is unclear if this is the same or different from the liquid sample or reagents described in claim 1.
For examination, it will be interpreted that they are the same sample and reagent.
Claims 15-18 are rejected by virtue of being dependent on a rejected claim.
Claim 15 recites “sample or reagents.” on line 3 where it is unclear if this is the same sample or reagent described in claim 14 (note claim 14 is only to a sample and a reagent, not reagents), or if it is the same as the liquid sample or reagents described in claim 1.
Claims 16-18 are rejected by virtue of being dependent on a rejected claim.
Claim 16 recites “a reaction part” on line 3 where it is unclear if this reaction part is the same or different from the reaction part described in claim 14.
For examination it will be interpreted that they are the same reaction part.
Line 4 recites “a sample” where it is unclear if this sample is the same or different from the sample described in prior claims.
Claims 17-18 are rejected by virtue of being dependent on a rejected claim.
Claim 17 recites “a groove” on line 2 where it is unclear if this groove is referring to one of the plurality of grooves described in claim 13, or if it is a new groove, or if it is referring to the groove described in claim 1.
Line 2 recites “to detect indicator” where it is unclear if this indicator is the same or different from the multiple indicator detection described in claim 1.
Claim 18 is rejected by virtue of being dependent on a rejected claim.
Claim 18 recites “wherein the reagent block is arranged in the groove far from the first port” on lines 1-2, where this is unclear because the reagent block has been described to be in a groove close to a first port. How can the reagent block be in two positions at once? Further, “the groove far from the first port” lacks antecedent basis as no groove far from the first port has been recited prior.
For examination, it will be interpreted that claim 18 is describing a different reagent block of the plurality of reagent blocks that is placed in a different groove that is located far from the first port in comparison to the reagent block and groove described in claim 17.
Line 2 recites “to detect indicator” where it is unclear if this indicator is the same or different from the multiple indicator detection describe in claim 1.
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(s) 1-7, 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbaspourrad (US-2024/0050943-A1) in view of Naka (US-2006/0018790-A1) and as evidenced by Drake Jr (US-3635677-A).
Regarding claim 1, Abbaspourrad teaches a microfluidic detection strip chip for multiple indicator detection of micro sample, including:
a substrate (support layer 130) configured to carry the microfluidic detection strip chip and participate in forming a groove (microchambers 118A-C) ([0058], [0059], [0061], Figures 2-3),
a microfluidic pipe (substrate layer 132 and top layer 136) configured to control a flow speed and direction of liquid sample or reagents and participate in forming the groove (118A-C), the microfluidic pipe (132 and 136) is bonded to a surface of the substrate (130) ([0056] see where in an example microfluidic circuits are fabricated as a mold where PDMS is applied and then peeled off the mold and applied to a support material such as glass and treated to seal the microfluidic circuits, [0059], Figures 2-3), and
The limitations “a substrate configured to carry the microfluidic detection strip chip”, “a microfluidic pipe configured to control a flow speed and direction of liquid sample or reagents” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of carrying a microfluidic detection strip chip and control a flow speed and direction of liquid sample or reagents. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
Please note that the liquid sample or reagents has not been positively recited in the claim, and is therefore not a part of the microfluidic detection strip chip.
[0079] of Abbaspourrad describes where a method involves loading a first reagent solution into the inlet port of a microfluidic device, and then loading a second reagent solutions, where the interaction between the first reagent solution and second reagent solution are detected in one or more of the microchambers. It is further described by [0077] of Abbaspourrad that the interaction between the first reagent solution and second reagent solution comprises detecting a colorimetric signal.
However, the first reagent solution of Abbaspourrad is not a reagent block configured to adsorb the liquid sample or reagents.
In the same problem solving area of a reagent reacting with a component in a sample to generate a pigment, Naka teaches a reagent film (Naka; [0018], [0086]).
Specifically, Naka teaches where a reagent is contained in a reagent film, where a reaction occurs between the reagent and sample in an analytical section to generate pigment (Naka; [0092]). The analytical section 3 can best be seen in Figure 1A, where this section is a cylindrical concave portion. [0144] of Naka further describes where suitable materials for the films include polyethylene.
It would have been obvious to one skilled in the art to modify the first reagent solution of Abbaspourrad such that it is instead a reagent film located in the microchambers as taught by Naka because Naka teaches that a reagent film allows operations for preparing a reagent and reacting the reagent with a component in the sample can be simplified thereby the whole process for analyzing a sample becomes a routine exercise (Naka; [0004]).
Examiner further finds that the prior art contained a device/method/product (i.e., a microfluidic device that has microchambers) which differed from the claimed device by the substitution of component(s) (i.e., a first reagent solution being loaded into the inlet port of the microfluidic device) with other component(s) (i.e., a reagent film already being present at reaction locations), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., reagent solution for a reagent film), and the results of the substitution (i.e., interaction with a sample of interest to produce a color change) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the first reagent solution of reference Abbaspourrad such that it is instead in the form of a reagent film as taught by Naka, since the result would have been predictable.
As seen in Figure 2 of Abbaspourrad there are a plurality of microchambers 118 where now the first reagent solution will be present in each microchamber in the form of a reagent film as taught by Naka.
The limitation “a plurality of reagent blocks configured to adsorb the liquid sample or reagents and perform chromogenic reaction” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Abbaspourrad and the first reagent (now in reagent film form) of modified Abbaspourrad is capable of adsorbing the liquid sample or reagents and perform a chromogenic reaction. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Abbaspourrad (see MPEP §2114).
It is evidenced by Drake Jr that a material such as polyethylene (Drake Jr recites “polyethyline” which is understood to be a typo) is a support media that adsorbs an aqueous phase mixed with a chromogenic formaldehyde reagent (Drake Jr; column 2 lines 6-23). As such, the reagent film of Naka that is made of polyethylene will be capable of sample or reagent adsorption.
Regarding claim 2, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 1. Abbaspourrad further teaches wherein the microfluidic pipe (132 and 136) comprises two independent pipeline systems configured to detect two different types of indicators (Abbaspourrad; [0065] see where there are three microfluidic circuits 110A-C labeled “high”, “intermediate” and “low” to describe the concentration of second reagent introduced into each of the inlet ports 112A-C, Figure 4).
Even though the microfluidic circuits 110A-C are connected to each other by connecting channels 134 as described by [0064] and seen in Figures 2 and 4 at the outlet port ends 114A-C, they are being considered “independent” pipeline systems because of [0065] describing that different concentrations of second reagent are being introduced into each microfluidic circuit 110A-C.
The limitation “two independent pipeline systems configured to detect two different types of indicators.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of detecting two different types of indicators. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
[0085] of Abbaspourrad describes that in some embodiments one microfluidic circuit is loaded with the second reagent at a time, where during his other inlet and outlet ports of other microfluidic circuits are blocked, sealed, or closed. It is therefore understood that the microfluidic circuits would be capable of being loaded with different second reagents.
Further please note that the two different types of indicators have not been positively recited in the claim, and are therefore not a part of the microfluidic detection strip chip.
Regarding claim 3, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 2. Abbaspourrad further teaches wherein the microfluidic pipe (132 and 136) comprises three or more independent pipeline systems configured to detect three or more different types of indicators (Abbaspourrad; [0065] see where there are three microfluidic circuits 110A-C labeled “high”, “intermediate” and “low” to describe the concentration of second reagent introduced into each of the inlet ports 112A-C, Figure 4).
Even though the microfluidic circuits 110A-C are connected to each other by connecting channels 134 as described by [0064] and seen in Figures 2 and 4 at the outlet port ends 114A-C, they are being considered “independent” pipeline systems because of [0065] describing that different concentrations of second reagent are being introduced into each microfluidic circuit 110A-C.
The limitation “three or more independent pipeline systems configured to detect three or more different types of indicators.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of detecting three or more different types of indicators. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
[0085] of Abbaspourrad describes that in some embodiments one microfluidic circuit is loaded with the second reagent at a time, where during his other inlet and outlet ports of other microfluidic circuits are blocked, sealed, or closed. It is therefore understood that the microfluidic circuits would be capable of being loaded with different second reagents.
Further please note that the three or more different types of indicators have not been positively recited in the claims and are therefore not a part of the microfluidic detection strip chip.
Regarding claim 4, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 3. Abbaspourrad further teaches wherein the microfluidic pipe (132 and 136) comprises a first port (see annotated Figure 2 below where the first port is the opening in substrate layer 132 that leads to each of the microfluidic circuits), a capillary network (defined where the fluid is flowing indicated by arrows 150A-C seen in Figure 2) and a second port (openings 152), the first port is connected with the capillary network, the capillary network is connected with the second port (152), the capillary network and a substrate (130) form a groove (118A-C), and the groove (118A-C) is connected with the capillary network through the second port (152) ([0063], Figures 2-3).
It is understood that there will be some amount of capillary action occurring in the microfluidic circuits due to their micron size, and thus the area where the fluid flows within the circuit will be a capillary network.
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Regarding claim 5, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 4. Abbaspourrad further teaches wherein the microfluidic pipe (132 and 136) further comprises a sample adding component (see annotated Figure 2 supra where the openings in the top layer 136 are a sample adding component) configured to add sample or reagents, the sample adding component is connected with the first port (see annotated Figure 2 supra, where the first ports are in substrate layer 132 and will be directly beneath the openings in the top layer 136).
The limitation “a sample adding component configured to add sample or reagents” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of adding sample or reagents. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
Further please note that the sample or reagents have not been positively recited in the claim, and are therefore not a part of the microfluidic detection strip chip.
Regarding claim 6, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 5. Abbaspourrad further teaches wherein the sample adding component comprises a sample hole (see claim 5 and annotated Figure 2 supra, where there will be a hole in top layer 136), the sample hole comprises a first interface configure to connect a syringe for filling sample ([0066] see where fluids in the microfluidic device can be controlled manually by introducing solutions into the inlet ports such as with a syringe attached to tubing, the inner wall of the hole in top layer 136 is an interface).
The limitation “the sample hole comprises a first interface configure to connect a syringe for filling sample.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of connecting a syringe for filling sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
Further please note that the syringe nor the sample have been positively recited in the claim, and is therefore not a part of the microfluidic detection strip chip.
Regarding claim 7, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 6. Abbaspourrad further teaches wherein the sample adding component further comprises an extension tube, the extension tube is connected with the first interface (the hole in top layer 136 is the sample hole where the inner wall of the hole is the interface) and a first port (annotated Figure 2 supra the opening in substrate layer 132 that leads to each of the microfluidic circuits) configured to increase a convenience of filling sample.
[0066] where the tubing described is an extension tube that will be connected to the microfluidic device.
The limitation “the extension tube is connected with the first interface and a first port configured to increase a convenience of filling sample.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of increasing convenience of filling sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
Please note that the sample has not been positively recited in the claim, and is therefore not a part of the microfluidic detection strip chip.
Regarding claim 11, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 4. Abbaspourrad further teaches wherein the second port (152) comprises a first stage second port, a second stage second port and a last stage second port, the first stage second port has a smallest opening configured to connect a groove close to a first port, and the last stage second port has a largest opening configured to connect the groove far from the first port.
In Figure 2 of Abbaspourrad, it is seen that in each microfluidic circuit there are multiple microchambers 118A-C. Looking specifically at microfluidic circuit 110A there are a plurality of microchambers 118A, and [0063] describes that microchamber 118A seen in Figure 3 has a diameter shown by arrow 158, a microchamber opening 152 (second port) and a height represented by arrows 156, where “This same structure (with differing sizes to create differing volumes) is replicated for all microchambers 118A, 118B, and 118C.” As such, there will be multiple staged ports in each of the microfluidic circuits. As further seen in Figure 2, the smallest microchamber (thus having the smallest opening 152) is closest to the opening in substrate layer 132 (first port), and the largest microchamber (thus having the largest opening 152) is furthest from the opening in substrate layer 132 (first port).
The limitation “the first stage second port has a smallest opening configured to connect a groove close to a first port, and the last stage second port has a largest opening configured to connect the groove far from the first port.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of connecting a groove close to a first port and connecting the groove far from the first port. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
Regarding claim 12, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 4. Abbaspourrad further teaches wherein the microfluidic pipe (132 and 136) comprise a plurality of micro valves configured to control a flow direction of liquid sample or reagents (Abbaspourrad; [0054] see where polymer-based microfluidic systems has an advantage where valves and pumps made with the same material may be readily integrated, and [0066] see that an operating system can control the introduction of fluids into and throughout the microfluidic device via valves).
As the device is a microfluidic device, it will have micro scale components and therefore the valves will be micro vales.
The limitation “a plurality of micro valves configured to control a flow direction of liquid sample or reagents.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Abbaspourrad and the apparatus of Abbaspourrad is capable of controlling a flow direction of liquid sample or reagents. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Abbaspourrad (see MPEP §2114).
Further please note that the liquid sample or reagents have not been positively recited in the claim, and are therefore not a part of the microfluidic detection strip chip.
Regarding claim 13, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 1. Abbaspourrad further teaches wherein a plurality of grooves (microchambers 118A-C) is arranged in a lattice (Abbaspourrad; [0059], Figure 2).
Abbaspourrad has been modified by Naka such that the first reagent solution that is in all of the microchambers is now a reagent film. As such, the microchambers will all have a reagent film within them.
The limitation “to accommodate a plurality of reagent blocks.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Abbaspourrad and the microchambers of Abbaspourrad are capable of accommodating a plurality of reagent blocks. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Abbaspourrad (see MPEP §2114).
Regarding claim 14, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 13. Naka further teaches wherein the reagent block comprises a reaction part configured to provide a chromogenic reaction between a sample and a reagent (Naka; [0090] see where the reagent film has a structure in which a filtration layer for separating erythrocytes, a reagent layer impregnated with a reagent, and a base member are laminated in this order, and then the reagent film is arranged in the analytical section 3. The reagent layer of the reagent film is the reaction part).
The limitation “configured to provide a chromogenic reaction between a sample and a reagent” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Abbaspourrad and the reagent layer of the reagent film of modified Abbaspourrad is capable of providing a chromogenic reaction between a sample and a reagent. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Abbaspourrad (see MPEP §2114).
The first reagent solution of Abbaspourrad is forming a colorimetric signal when reacted with the second reagent solution, where the first reagent solution of Abbaspourrad is now a in the form of a reagent film as taught by Naka.
Please note that the sample and reagent have not been positively recited in the claim, and are therefore not a part of the microfluidic detection strip chip.
Regarding claim 15, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 14. Naka further teaches wherein the reagent block further comprises a waste liquid absorption part configured to adsorb sample or reagents (Naka; [0090] see where the reagent film has a structure in which a filtration layer for separating erythrocytes, a reagent layer impregnated with a reagent, and a base member are laminated in this order, and then the reagent film is arranged in the analytical section 3. The filtration layer is a waste liquid absorption part as it is absorbing a first set of components).
The limitation “a waste liquid absorption part configured to adsorb sample or reagents” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Abbaspourrad and the filtration layer of the reagent film of modified Abbaspourrad is capable of absorbing sample or reagents. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Abbaspourrad (see MPEP §2114).
Please note that the sample and reagent have not been positively recited in the claim, and are therefore not a part of the microfluidic detection strip chip.
Claim(s) 12 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Abbaspourrad (US-2024/0050943-A1) and Naka (US-2006/0018790-A1), and in further view of McDevitt (WO-2005/083423-A2).
Regarding claim 12, modified Abbaspourrad teaches the microfluidic detection strip chip according to claim 4. If it is determined that Abbaspourrad does not teach micro valves, in the same problem solving area of controlling flow through microfluidic channels, McDevitt teaches passive microvalves (McDevitt; page 72 lines 8-14).
Specifically, McDevitt teaches where valves include valves configured for microfluidic channels such as passive microvalves, where in an example provided for pinch valves they are used to control fluid in microfluidic channels as well as control the direction of flow (McDevitt; page 72 lines 8-14). It is understood that the passive microvalves will similarly control fluid in microfluidic channels as well as the direction of flow.
It would have been obvious to one skilled in the art to modify the microfluidic circuits of Abbaspourrad such that they include passive microvalves as taught by McDevitt because McDevitt teaches that the passive microvalves control fluid in microfluidic channels and controls the direction of flow (McDevitt; page 72 lines 8-14).
The limitation “wherein the microfluidic pipe further comprise a plurality of micro valves configured to control a flow direction of liquid sample or reagents.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Abbaspourrad and the apparatus of modified Abbaspourrad is capable of controlling a flow direction of liquid sample or reagents. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Abbaspourrad (see MPEP §2114).
Further the liquid sample or reagents have not been positively recited in the claim, and are therefore not a part of the microfluidic detection strip chip.
Allowable Subject Matter
Claims 8-10 and 16-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Regarding claim 8 the current closest prior art of record is Abbaspourrad in view of Naka. It would not be obvious to one skilled in the art to modify the openings in the top layer 136 (defining the sample adding component) to include a reagent hole. While there are multiple openings seen in Figure 2 of Abbaspourrad, there is only one per microfluidic circuit and it would not be obvious to have two holes per microfluidic circuit.
Claims 9-10 would be allowable by virtue of being dependent on claim 8.
Regarding claim 16 the current closest prior art of record is Abbaspourrad in view of Naka. It would not be obvious to one skilled in the art to modify the reagent film of Naka such that it includes a filter membrane part arranged between a reaction part and second port as Naka already teaches where there is a filtration layer (the filtration layer of Naka is currently being mapped to the waste liquid absorption part). Even if the filtration layer of Naka is mapped to the filter membrane part of claim 16, it would not be obvious to one skilled in the art to modify the microchambers of Abbaspourrad to include a waste liquid absorption part because the microchambers are understood to be sized for the desired amount of fluid.
Claims 17-18 would be allowable by virtue of being dependent on claim 16.
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796