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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/28/2025 has been entered.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the amended specification does not correspond to the instant filed drawings, and are instead are referred back to the drawings of WO2018/017120, which are not included within this Application. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: the microfluidic device is referred to as containing a non-transitory computer-readable medium without the appropriate associated hardware for execution. Appropriate correction is required. Claim 1 should instead recite, “the microfluidic device comprising a controller (or processor), a non-transitory computer-readable medium storing instructions that, when executed by controller (or processor), cause the controller (or processor) to perform operations comprising:.."
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
The Applicant argues that Davies teaches using one heater to heat a fluid in "a preheating zone 11(a)" and then heating fluid "in a high temperature area." Thus, Davies simply heats fluid to different temperatures in different distinct zones. Davies does not teach or suggest using one heater to heat a fluid in a portion of a loop to a steady- state temperature in that portion of the loop and then using a different heater to heat the fluid in the same portion of the loop in response to the fluid reaching that steady-state temperature, as recited in claim 1.
In response to this argument, the Examiner respectfully disagrees as the claimed invention states that the actuator, acting as the first heater, is located generally within the first branch to heat fluid that eventually flows within the portion of the pump loop wherein the heater is then used to further heat the fluid within the pump loop. The locations of heating have not been disclosed to be the exact same area and the drawings of the instant invention teach away from the actuator and heater occupying the same space to heat the exact same portion. The prior art reference of Govyadinov teaches the use of the actuator to heat a sample to a vaporizing, or denaturing, temperature, analogous to the preheater 11(a) of Davies, and the modification of Davies includes the heater 11 that contacts fluid within a pump loop to maintain the temperature of sample following denaturation for PCR operations.
Further, the Applicant argues that Davies does not teach or suggest using separate heaters to heat the same portion of a loop or zone at different times or in response to any conditions being met.
However, the Examiner respectfully disagrees as the preheater 11(a) is used to heat the fluid that flows through the first heater 11, where the heaters and the fluid flowing between them are isothermal, see [0050]- [0052] in Davies.
Status of Objections and Rejections
All rejections from the previous office action are maintained.
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 1-5, 9-10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Govyadinov (US 2014/0377145), and further in view of Davies et al. (US 2015/0140645).
Regarding claim 1, Govyadinov teaches a microfluidic device (microfluidic mixing device 1300, see [0001] and Fig. 13A) comprising
a plurality of pump loops (M-shaped channels 1324, 1325, see Fig. 13A and [0105]), each of the plurality of pump loops comprising:
a first branch (1305), a second branch (1315), and a connecting section connecting the first branch and the second branch (1310),
wherein the first branch includes a first opening and the second branch includes a second opening, and wherein the first opening and the second opening are in direct fluid communication with the transport channel (branches 1305 and 1315 have openings that connect to a main channel 121 (transport channel), see Fig. 13A and [0107]);
an actuator positioned in the first branch (actuator 125-1 in first branch 1305, see Fig. 13A and [0105]).
and the microfluidic device storing a non-transitory computer-readable medium storing instructions (the computer program product for operating the actuator/heater, see [0043] and [0115]) that, when executed, are configured to cause the microfluidic device to: use the actuator to heat the fluid flowing within the portion of the pump loop until the fluid reaches a steady-state operating temperature wherein the microfluidic device only uses the actuator to heat the fluid flowing within the portion of the pump loop until the fluid reaches the steady-state operating temperature; and (actuators 125 are used to heat fluid within the pump loops, see [0051] and [0056], where the actuators are controlled using a processor and computer readable storage medium and turn activate in response to received signals, see [0113] – [0115]);
However, Govyadinov does not teach or suggest a heater positioned remote to the plurality of pump loops, and the non-transitory computer-readable medium storing instructions that, when executed, are configured to cause the microfluidic device heater to heat fluid flowing within a portion of a pump loop of the plurality of pump loops through material of the first connecting section of the pump loop and activate, responsive to the fluid reaching the steady-state operating temperature, to heat the fluid flowing within the portion of the pump loop, wherein the microfluidic device switches control from the actuator to the heater such that the heater is the only device controlled to heat the fluid flowing within the portion of the pump loop responsive to the fluid reaching the steady-state operating temperature.
However, in the analogous art of cycling/mixing samples through fixed conduits, Davies et al. teaches a device comprising a heater positioned remote to the plurality of pump loops (heaters 18 remote to the conduit 10, see Fig. 2 and 4, [0048] and [0050]), and the non-transitory computer-readable medium storing instructions that, when executed, are configured to cause the microfluidic device heater to heat fluid flowing within a portion of a pump loop of the plurality of pump loops through material of the first connecting section of the pump loop (heaters 18 heats fluid within serpentine loops of the pump channel using thermal blocks 11 and 13, see Fig. 4, [0048], and [0050], where the controller causes fluid to dwell in one region to reach a specific temperature for denaturation or other PCR operations, see [0066] – [0067])) and the microfluidic device configured to: use the actuator to heat the fluid flowing within the portion of the pump loop until the fluid reaches a steady-state operating temperature and activate, responsive to the fluid reaching the steady-state operating temperature, the heater to heat the fluid flowing within the portion of the pump loop (PID feedback control system controls the heaters to heat until a certain temperature is reached, see [0048], [0050], [0099], and Claim 1) wherein the microfluidic device switches control from the actuator to the heater such that the heater is the only device controlled to heat the fluid flowing within the portion of the pump loop responsive to the fluid reaching the steady-state operating temperature (the device switches control from a preheating area to thermal control by the heaters alone to allow denaturation prior to thermal cycling, see [0060]).
Because it was known in the art before the effective filing date of the instant application to have modified a microfluidic device used to heat a sample prior to thermal cycling within the same device as evidenced by Davies et al., it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the device comprising actuators of Govyadinov to include the remote heaters with feedback control of Davies et al. for the benefit of promoting PCR and the required associated thermal cycling within a single microfluidic device (see [0045] – [0049] in Davies et al.). Modifying the device of Govyadinov to incorporate automating by a processor/controller the heaters and associated control of Davies additionally would have yielded the reasonable expectation of successfully facilitating the maintaining the temperature of a sample within a microfluidic device at a specific area, as is required by the instant application. Further, the modification of the controller of Govyadinov to implement the dual temperature control as exemplified by Davies et al. would have been obvious as all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A and 2143.02).
Regarding claim 2, modified Govyadinov teaches the device of claim 1 wherein the heater (heaters 18) provides heating to multiple adjacent pump loops (the heaters 18 provide heat to adjacent loops of the channel 10, see Fig. 2 and 4, and [0048]- [0050] in Davies).
Regarding claim 3, modified Govyadinov teaches the device of claim 1, wherein each pump loop comprises an individual resistive heater such that adjacent pump loops may be heated to different temperatures (each M-shaped channel 1324 & 1325 (pump loops) contains an individual actuator 125-2 acting as a thermal resistor, see Fig. 13A, [0056], and [0105]).
Adjacent pump loops being heated to different temperatures is a limitation with respect to an intended use of individual resistive heaters. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963). The apparatus of Govyadinov is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim since each of the actuators are separate from each other and would therefore have individual temperature control.
Regarding claim 4, Govyadinov teaches the device of claim 1 comprising a plurality of pump loops (M-shaped channels), but does not teach wherein each of the plurality of pump loops further comprises a cooling zone.
However, in the analogous art of microfluidic platforms, Davies et al. teaches a microfluidic device ([0045]) wherein each of the plurality of pump loops further comprises a cooling zone (thermal zone 12 with water channel 19 used to maintain a low, or cooler, temperature, see Fig. 4 and [0040]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date before the instant application to have modified the microfluidic device of Govyadinov to include the thermal block and its respective water channel (cooling zone) of Davies et al. for the benefit of controlling the temperature gradient between the serpentine loops of the channel 10 (see [0048] in Davies et al.). The modification of the device of Govyadinov to include the cooling water channel of Davies et al. would have had the reasonable expectation of successfully facilitating heat transfer on a microfluidic platform.
Regarding claim 5, Govyadinov teaches the device of claim 1, wherein each of the plurality of pump loops further comprises a second heater to apply heating to a separate portion of the pump loop (each M-shaped channel 1324 & 1325 (pump loops) contains an individual actuator 125-3 acting as a second thermal resistor, see Fig. 13A, [0056], and [0105]).
Regarding claim 9, Govyadinov teaches the device of claim 1, wherein a pump loop of the plurality of pump loops further comprises a second actuator in the second branch of the pump loop (each M-shaped channel 1324 & 1325 (pump loops) contains another actuator 125-3 in leg 1315 (second branch), see Fig. 13A and [0105]).
Regarding claim 10, Govyadinov teaches the device of claim 1, wherein a branch of a pump loop comprises a serpentine section (each leg 105/1315 (branches) of M-shaped channels 1324/1325 (pump loop) are curved (serpentine), see Fig. 13A).
Regarding claim 16, modified Govyadinov teaches the device of claim 1, wherein the heater separately provides heating directly to the material of the first connecting section of each of the plurality of pump loops (the heaters 18 are used to heat the fluid pumped within the loops (see 0048] – [0050] in Davies et al.), which would include the first connecting section as the heaters heat the fluid of the entire device).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Govyadinov (US 2014/0377145) in view of Davies et al. (US 2015/0140645) as applied to claim 1 above, and further in view of A. Govyadinov et al. (US 2015/0085021).
Regarding claim 6, Govyadinov teaches the device of claim 1, comprising a transport channel (a main channel 121), but does not teach a plurality of protrusions positioned in the transport channel.
However, in the analogous art of devices for moving devices on substrates, A. Govyadinov et al. teaches a plurality of protrusions positioned in the transport channel to facilitate fluid flow from the second opening of one pump loop to the first opening of an adjacent pump loop (flow obstructions 460 (protrusions) located within passage 244 (transport channel), see Fig. 6 and [0057]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date before the instant application to have modified the main channel of the microfluidic device of Govyadinov to include the flow obstructions of A. Govyadinov et al. for the benefit of preventing the flow of contaminants into the fluidic system (see [0057] in A. Govyadinov et al.). The modification of the microfluidic main channel of Govyadinov to include the flow obstructions of A. Govyadinov et al. would have had the reasonable expectation of successfully facilitating the transportation of impurity-free fluid within a microfluidic device.
Regarding clam 7, Govyadinov teaches the device of claim 1, wherein the plurality of pump loops are organized into pairs of pump loops and (M-shaped channel 1324 & 1325 (pump loop) are paired, see Fig. 13A), but does not teach that a first pump loop and second pump loop of a pair pump loops are located on opposite sides of the transport channel.
However, the analogous art of A. Govyadinov et al. teaches a device wherein a first pump loop and second pump loop of a pair pump loops are located on opposite sides of the transport channel (loops of passage 244 (pump loops) are located opposite each other, see Fig. 4 and [0047]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date before the instant application to have modified the M-shaped channels of Govyadinov to be opposite each other as exemplified by A. Govyadinov et al. for the benefit of providing circulation of fluids across different fluidic loops (see [0046] in A. Govyadinov et al.). The modification of the M-shaped channels of Govyadinov et al. to be opposite each other as exemplified by A. Govyadinov et al. would have had the reasonable expectation of successfully facilitating fluid exchange between loops of a microfluidic device.
Regarding claim 8, Govyadinov modified by A. Govyadinov et al. teaches the device of claim 7, wherein the second opening of the first pump loop of the pair of pump loops is situated opposite the first opening of the second pump loop of the pair of pump loops in the transport channel (the outlet 256 of a first loop of the passage 244 is located opposite to the inlet 254 is of an opposing loop of the passage 244 in the slot 240, see Fig. 4 and [0045]- [0047]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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 http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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 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 would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.N.M./ Examiner, Art Unit 1758
/SAMUEL P SIEFKE/ Primary Examiner, Art Unit 1758