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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/18/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 18 September 2025.
Claims 1 and 3-11 are pending.
Claims 1, 7, and 10 are amended.
Claim 2 is cancelled.
No claims are withdrawn from consideration.
No claims are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ulmanella et al. (US 2007/0280856 A1), referred to hereinafter as “Ulmanella”, in view of Woudenberg et al. (US PAT 6,825,047 B1), referred to hereinafter as “Woudenberg”, Lin et al. (US 2016/0144363 A1), referred to hereinafter as “Lin”, Dantsker et al. (US 2002/0153046 A1), hereinafter “Dantsker”, and Anderson et al. (US 2011/0201099 A1), hereinafter “Anderson”.
Regarding Claim 1, Ulmanella teaches a microchannel device used for a test in which a test solution containing a sample and an agent are to act on each other, the microchannel device having a plate shape (Fig. 1), the microchannel device comprising:
a first opening 15 for receiving the test solution that is to be injected therethrough (Fig. 1 and [0067]: “…the sample fluid may be supplied via an inlet 15…”);
a main channel 26 through which the injected test solution can flow (Fig. 1 and [0067]: “…a main fluid channel 26…”),
the main channel 26 including an inlet-side end that communicates with the first opening 15 and an outlet-side end located opposite to the inlet-side end (Fig. 1 shows the main channel 26 having an inlet side end adjacent to the inlet 15, and an outlet side end opposite the inlet side end.);
a plurality of microchannels 22, each microchannel including a first-side end that communicates with the main channel 26 and a second-side end located opposite to the first-side end (Fig. 1 and [0067]: “…a plurality of inlet branch channels 22…”);
a plurality of second openings 28 wherein each second opening communicates with the second-side end of a respective one of the microchannels 22 (Fig. 1 and [0067]: “The outlet branch channels 24 are in flow communication with vent chambers 28.”);
a plurality of first reservoirs 20 where the agent is to be stored, each first reservoir being provided in a respective one of the microchannels 22 (Fig. 1 and [0082]: “…dried reagent into the chamber 20…” – [0013]: “In accordance with various exemplary embodiments, at least some of the sample chambers of a microfluidic device may include a dried reagent disposed within the at least some sample chambers proximate the inlet channels in flow communication with the at least some sample chambers.”);
a gas permeable membrane that covers at least one of the second openings ([0111]: “…a plurality of gas-permeable, liquid-impermeable membrane strips were placed on the side of the PSA film opposite the COP substrate and over each row of vent holes and vent chambers 28.”),
wherein the plurality of microchannels include a first group of microchannels and a second group of microchannels (Fig. 1 shows a first group branching from a lower portion of the main channel 26, and a second group branching from an upper portion of the main channel 26, as seen through Fig. 1.), as in Claim 1.
Further regarding Claim 1, Ulmanella does not specifically teach the microchannel device discussed above wherein the microchannels of the first group and the microchannels of the second group are arranged as being aligned in a first direction when the microchannel device is viewed in a plan view, and the first group and the second group are arranged as being aligned in a second direction orthogonal to the first direction, as in Claim 1.
However, Woudenberg teaches a respective microchannel device/fluid distribution network wherein the branching microchannels 68a/68b/68c are arranged as aligned parallel in a first direction (the vertical direction as viewed through the plan view of Fig. 4). Said microchannels are further arranged into three groups branching from the main channel 66a/66b/66c, wherein said groups are arranged as aligned in parallel in a second direction orthogonal to the first direction (the horizontal direction as viewed through the plan view of Fig. 4). Woudenberg further states that the channels and chambers of the device may be configured in numerous ways (col. 2, line 42), as is similarly contemplated by Ulmanella ([0060-0062]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microchannel device of Ulmanella so as to arrange the microchannels as aligned in a first direction and the groups of microchannels as aligned in a second direction orthogonal to the first direction, such as suggested by Woudenberg to provide an obvious alternative arrangement that remains to provide a sample introduced through a single common inlet to a plurality of chambers for performing a diagnostic on said sample, wherein these arrangements are obvious alternatives where all of which commonly represent branching channels and chambers from a main channel and would have a reasonable expectation of success therein.
Further regarding Claim 1, Ulmanella does not specifically teach the microchannel device discussed above comprising a second reservoir where the test solution remaining in the main channel is collected, the second reservoir being provided at the outlet-side end of the main channel, as in Claim 1.
However, Lin teaches a respective microfluidic device comprising a main channel 440 which feeds a plurality of detection/measurement chambers 450 similarly as in Ulmanella, wherein the device further comprises a waste chamber 470 positioned at the outlet side of the main channel (Fig. 3C and [0050, 0057]).
Therein, an integrated waste chamber provides a dedicated space to collect waste liquid, thereby preventing contamination to a user, as well as prevents backflow through the device, thereby preventing disruption of liquid contained in each measuring chamber, as is appreciated prevalently in the art of microfluidic devices. – See MPEP 2144(I): The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic device of Ulmanella so as to include a second reservoir where the test solution remaining in the main channel is collected, the second reservoir being provided at the outlet-side end of the main channel, such as suggested by Lin, so as to prevent contamination to a user, as well as prevents backflow through the device, thereby preventing disruption of liquid contained in each measuring chamber as is appreciated prevalently in the art of microfluidic devices; and would have a reasonable expectation of success therein.
Further regarding Claim 1, Ulmanella does not specifically teach the microchannel device discussed above further comprising: a third opening provided in the second reservoir, the plurality of microchannels and the third opening are configured such that the test solution flows into the plurality of microchannels when the third opening is closed, and such that the test solution flows from the main channel into the second reservoir by opening the third opening, as in Claim 1.
However, Lin teaches the second/waste reservoir as discussed above regarding Claim 1, wherein a vent opening is provided in said second/waste reservoir to allow gas trapped therein to escape, thereby allowing inflow of fluid from the main channel (Fig. 3B shows the four air vents 480 – see also para. [0050]). Further in Lin, the plurality of microchannels and the third opening are configured such that the test solution flows into the plurality of microchannels when the third opening is closed (Fig. 3C: Vents 480 about the periphery of the main channel 440 permit evacuation of air allowing sample to flow through the main channel when the vent opening of the second reservoir 470 is covered.), and such that the test solution flows from the main channel into the second reservoir by opening the third opening (Fig. 3C: The third opening (vent of the second reservoir 470 as seen through the figure) controls flow of sample fluid to the second reservoir 470 by venting air pressure from said reservoir, whereas additional vents permit flow through the main and side channels of the device. Thus, the sample liquid is controlled from entering the second reservoir via covering and uncovering of the third opening, wherein uncovering allows for air evacuation and flow of sample fluid.). Therein, this arrangement permits further control over sample liquid flow, helping to prevent premature flow of the sample liquid into the waste chamber.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the device of Ulmanella with the waste chamber of Lin as discussed above regarding Claim 1, that a third opening be provided in the second/waste reservoir so as to allow gas trapped therein to escape, thereby allowing inflow of fluid from the main channel and enabling the basic functional principles of the device; and would have a reasonable expectation of success therein, and would configure the plurality of microchannels and the third opening such that the test solution flows into the plurality of microchannels when the third opening is closed, and such that the test solution flows from the main channel into the second reservoir by opening the third opening, as further suggested by Lin, so as to enable further control over the sample fluid, preventing premature entry into the waste chamber such as in Lin, thereby reducing errors related to improper sample flow, as would be reasoned by one skilled in the art given ordinary fluidic principles.
Further, Anderson specifically teaches this principle of fluid control specifically relating to a vent connected to a waste chamber ([0175, 0219]) so as to more precisely control fluid flow and avoid premature sample entry into the waste chamber. Thus, one skilled in the art would find it obvious to apply these principles to the device of Ulmanella/Lin, even though Lin does not specifically describe opening/closing of the third port, so as to achieve the discussed fluid control benefits.
Further regarding Claim 1, Ulmanella does not specifically teach the microchannel device discussed above wherein the plurality of microchannels are higher in channel resistance than the main channel, as in Claim 1.
However, Dantsker teaches a respective layered fluidic device wherein a main channel 17 evenly divides a fluid flow to a plurality of side channels 19/20/21, wherein even splitting is provided by maintaining substantially equal fluidic impedance across all side channels, and wherein such equal fluid impedance to the side channels have a greater impedance (i.e. “resistance” herein) than that of the main channel ([0031]). See further Figs. 8A-C (and para. [0055]) showing narrowing of each branching channel, thereby providing fluidic resistance at each channel junction of the branching channels for equal fluid delivery ([0031]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Ulmanella wherein the plurality of microchannels are higher in channel resistance than the main channel, such as suggested by Dantsker, so as to ensure even filling of each chamber, thereby reducing errors due to inconsistent sample volumes measured.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein when the microchannel device is viewed in the plan view, the second openings which communicate with the second-side ends of the microchannels of the first group and the second openings which communicate with the second-side ends of the microchannels of the second group are arranged to face each other (Fig. 24 A/B shows an embodiment wherein the openings 2428 face each other in as much as is claimed and required herein.),
And the main channel is a single main channel 22 that is arranged at a position surrounding an outer side of the plurality of microchannels 22 (Fig. 1), as in Claim 3.
Further regarding Claim 3, if the arrangement of the main channel and second openings in Ulmanella are not taken as providing for the claimed arrangement of main channel and second openings, then such modification would have been obvious to one of ordinary skill in the art.
Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). The device having the claimed relative arrangement of second openings and a single main channel arranged at a position surrounding an outer side of the plurality of microchannels would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the second openings/main channel, given that the prior art device similarly teaches microchannels branching from a main channel.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein the gas permeable membrane is a single gas permeable membrane which covers the second openings which communicate with the second-side ends of the microchannels of the first group and the second openings which communicate with the second-side ends of the microchannels of the second group ([0067]: “In addition, one or more gas-permeable membranes and/or vent holes provided in a film layer may be provided.”), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein when the microchannel device is viewed in the plan view, the second openings 28 which communicate with the second-side ends of the microchannels of the first group and the second openings 28 which communicate with the second-side ends of the microchannels of the second group are arranged on respective sides of opposing sides of the microchannel device, and the main channel is a single main channel 26 that is arranged in a central portion of the microchannel device (Fig. 1 shows the upper group and lower group of microchannels as arranged on respective opposing sides of the device, wherein a central main channel 26 is arranged in a central portion of the device in as much as is claimed and required herein.), as in Claim 5.
Further regarding Claim 5, if the arrangement of the main channel and second openings in Ulmanella are not taken as providing for the claimed arrangement of main channel and second openings, then such modification would have been obvious to one of ordinary skill in the art.
Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). The device having the claimed relative arrangement of second openings and a single main channel arranged in a central portion of the microchannel device would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the second openings/main channel, given that the prior art device similarly teaches microchannels branching from a main channel.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein when the microchannel device is viewed in the plan view, the second openings 28 which communicate with the second-side ends of the microchannels of the first group are arranged in a central portion of the microchannel device and the second openings 28 which communicate with the second-side ends of the microchannels of the second group are arranged on one outer side of the microchannel device, and the main channel is a single main channel 26 that extends along an outer side of the first group and passes through the central portion of the microchannel device (Fig. 1 shows the first group as arranged in the center of the device and the second group as arranged on a periphery/outer side of the device, wherein the main channel 26 passes through the central portion.), as in Claim 6.
Further regarding Claim 6, if the arrangement of the main channel and second openings in Ulmanella are not taken as providing for the claimed arrangement of main channel and second openings, then such modification would have been obvious to one of ordinary skill in the art.
Examiner further notes that mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). The device having the claimed relative arrangement of second openings and a single main channel arranged at a position that passes on an outer side of the first group and passes through the central portion of the microchannel device would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the second openings/main channel, given that the prior art device similarly teaches microchannels branching from a main channel.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Ulmanella does not specifically teach the microchannel device discussed above wherein the second reservoir is a buffer space larger in volume than the main channel, as in Claim 7.
However, Lin teaches the waste chamber 470 as being larger in volume than the main channel 440 (see fig. 6E and para. [0055]) so as to prevent liquid from accumulating in the main channel, thereby reducing backflow through the device, thus preventing disruption of fluid contained in each of the measuring chambers 450. Therein, one of ordinary skill in the art would readily find it obvious to provide a waste chamber sufficient enough in volume so as to accept any and all residual waste liquid from the device so as to achieve the fundamental principles of the waste chamber of preventing backflow and providing containment of waste liquid. – See MPEP 2144(I): The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the device of Ulmanella with the waste chamber of Lin, to provide the waste chamber as having a greater volume than the main channel so as to accept any and all residual waste liquid from the device so as to achieve the fundamental principles of the waste chamber of preventing backflow and providing containment of waste liquid; and would have a reasonable expectation of success therein.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein the buffer space is provided with a water absorbing member ([0122]: “…the reagent at the inlet side tended to absorb the sample as it entered the chamber…” – [0057]: “The sample may be a biological sample, for example, an aqueous biological sample, an aqueous solution…”), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein the microchannels are higher in channel resistance than the main channel ([0097]: “…the interior surface portions of the chamber that join the interior surface portions defining the lumen of the inlet and/or the outlet channel intersect each other orthogonally. With such a configuration, the openings leading to the inlet and outlet channels are relatively narrow.” – These narrow openings of the microchannels to the collection chamber result in greater flow resistance of the microchannels.), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein the gas permeable membrane further covers the third opening (Para. [0067] teaches a single gas-permeable membrane for covering the second openings 28 of the device, wherein this membrane further covers the third openings when arranged over the device as discussed in Ulmanella.), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Ulmanella teaches the microchannel device discussed above wherein the plurality of microchannels further include a third group of microchannels (Fig. 24 A/B shows an embodiment having three groups of branching microchannels 2426 from a main channel not specifically shown.), as in Claim 11.
Examiner further notes that mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, one of ordinary skill in the art would find it obvious to provide a third group of the plurality of microchannels if more microchannels are desired within the device to provide more testing chambers for more analytes.
Response to Arguments
Rejections Under 35 USC 103
Applicant’s arguments are on the grounds that allegedly none of the previously applied prior art references teach or suggest the amended Claim 1 recitation requiring the main channel, the plurality of microchannels and the third opening being configured such that the test solution flows into the plurality of microchannels when the third opening is closed, and such that the test solution flows from the main channel into the second reservoir by opening the third opening, as in amended Claim 1. Applicant acknowledges the “third opening” as provided through Lin is directed to gas balancing when fluid flows into the “second reservoir” 470 of Lin.
Applicant’s arguments are not persuasive because the device of Lin does provide for the amended Claim 1 limitation wherein the plurality of microchannels and the third opening are configured such that the test solution flows into the plurality of microchannels when the third opening is closed (Fig. 3C: Vents 480 about the periphery of the main channel 440 permit evacuation of air allowing sample to flow through the main channel when the vent opening of the second reservoir 470 is covered.), and such that the test solution flows from the main channel into the second reservoir by opening the third opening (Fig. 3C: The third opening (vent of the second reservoir 470 as seen through the figure) controls flow of sample fluid to the second reservoir 470 by venting air pressure from said reservoir, whereas additional vents permit flow through the main and side channels of the device. Thus, the sample liquid is controlled from entering the second reservoir via covering and uncovering of the third opening, wherein uncovering allows for air evacuation and flow of sample fluid.). Therein, as discussed above in the body of the action, this arrangement permits further control over sample liquid flow, helping to prevent premature flow of the sample liquid into the waste chamber, as would be readily reasoned by one of ordinary skill in the art given basic fluidic principles of the art. Further, Anderson specifically teaches this principle of fluid control specifically relating to a vent connected to a waste chamber ([0175, 0219]) so as to more precisely control fluid flow and avoid premature sample entry into the waste chamber. Thus, one skilled in the art would find it obvious to apply these principles to the device of Ulmanella/Lin, even though Lin does not specifically describe opening/closing of the third port, so as to achieve the discussed fluid control benefits.
Herein, these additional references of Dantsker and Anderson are included herein as necessitated by Applicant’s amendments to Claim 1 discussing configurations of the third port for flow control.
As discussed above, Dantsker a teaches a respective layered fluidic device wherein a main channel 17 evenly divides a fluid flow to a plurality of side channels 19/20/21, wherein even splitting is provided by maintaining substantially equal fluidic impedance across all side channels, and wherein such equal fluid impedance to the side channels have a greater impedance (i.e. “resistance” herein) than that of the main channel ([0031]). See further Figs. 8A-C (and para. [0055]) showing narrowing of each branching channel, thereby providing fluidic resistance at each channel junction of the branching channels for equal fluid delivery ([0031]).
Further, Anderson specifically teaches this principle of fluid control specifically relating to a vent connected to a waste chamber ([0175, 0219]) so as to more precisely control fluid flow and avoid premature sample entry into the waste chamber. Thus, one skilled in the art would find it obvious to apply these principles to the device of Ulmanella/Lin, even though Lin does not specifically describe opening/closing of the third port, so as to achieve the discussed fluid control benefits.
Thus, Examiner respectfully sets forth the rejection of Claims 1 and 3-11 as unpatentable under 35 USC 103 over Ulmanella in view of Woudenberg, Lin, Dantsker, and Anderson, as discussed above in the body of the action, wherein this new grounds of rejection including Dantsker and Anderson is necessitated by Applicant’s amendments to Claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798