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 .
Response to Amendment
The Amendment filed on 3/26/2026 has been entered. Claims 1, 2 and 4-15 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the non-final Office Action mailed 1/22/2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4-6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2012/0244604, hereinafter Kornilovich.
Regarding claim 1, Kornilovich teaches a device (item 500) for conducting a reaction with a fluid sample (figure 5A), the device comprising: a microfluidic channel (labeled in figure below) directly between and fluidically coupling a first fluid reservoir (item 202) with a second fluid reservoir (item 210) (the entire structure circled below is considered to be the microfluidic channel and is therefore considered to be directly between the first and second fluid reservoir); a number of heating elements (paragraph [0037] and as shown in figure 4 as item 402) along the microfluidic channel (paragraph [0037] and as shown in figure 4 as item 402); and inertial pumps (the two outer most double sided arrows as shown in figure 5A) at each of opposite ends of the microfluidic channel (figure 5A); and a controller (paragraph [0045]).
Kornilovich fails to specifically teach the controller is configured by machine-readable instructions to alternatively activate the plurality of inertial pumps to cause fluid within the microfluidic channel to oscillate back and forth between the first fluid reservoir and the second fluid reservoir fluidically coupled by the microfluidic channel.
Kornilovich further teaches the controller allows for controller of the parallel PCR architecture so that the controller can implement different cycling protocols with respect to each of the N linear PCR processes such that each process can have a different number of temperature cycles, a different mixture flow rate, different amounts of time per PCR reaction chamber, and different temperatures within the PCR reaction chambers (paragraph [0045]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the controller alternatively activate the plurality of inertial pumps to cause fluid within the microfluidic channel to oscillate back and forth between the first fluid reservoir and the second fluid reservoir fluidically coupled by the microfluidic channel because it would allow for each process to have a different number of temperature cycles, a different mixture flow rate, different amounts of time per PCR reaction chamber, and different temperatures within the PCR reaction chambers (paragraph [0045]).
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Regarding claim 2, Kornilovich teaches wherein one of the inertial pumps is located at each interface between the microfluidic channel and one of the two reservoirs (figure 5A).
Regarding claim 4, Kornilovich teaches each heating element comprises a thin-film resistor (paragraphs [0031] and [0042]).
Regarding claim 5, Kornilovich teaches the reaction is a Polymerase Chain Reaction (PCR) (intended use MPEP § 2114 (II)); and the number of heating elements is three (paragraph [0037] and as shown in figure 4 as item 402), each heating element to maintain a different temperature in the PCR (intended use MPEP § 2114 (II) and is taught in paragraph [0037]).
Regarding claim 6, Kornilovich teaches wherein: a first heating element (paragraph [0037] and one of item 402 shown in figure 4) of the number of heating elements corresponds to a denature phase of the PCR (intended use MPEP § 2114 (II) and is taught in paragraph [0037]); a second heating element (paragraph [0037] and one of item 402 shown in figure 4) of the number of heating elements corresponds to an anneal phase of the PCR (intended use MPEP § 2114 (II) and is taught in paragraph [0037]); a third heating element (paragraph [0037] and one of item 402 shown in figure 4) of the number of heating elements corresponds to an extension phase of the PCR (intended use MPEP § 2114 (II) and is taught in paragraph [0037]).
Regarding claim 9, Kornilovich teaches each inertial pump comprises a thermal inkjet pump (paragraph [0059]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornilovich in view of United States Patent No. 5,720,923, hereinafter Haff.
Regarding claim 8, Kornilovich teaches all limitations of claim 1; however, Kornilovich fails to teach an injector to insert a bubble of immiscible fluid on either side of the fluid sample in the microfluidic channel.
Haff teaches a nucleic acid amplification apparatus which utilizes a syringe to inject a bubble of immiscible fluid into the flow stream so that the it is ensured that slug flow dominates throughout the flow path so that each volume element of the reaction mixture experiences the same number and duration of thermal incubations (Haff, column 10, lines 21-38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added an injector which injects a bubble of immiscible fluid because it would ensure that slug flow dominates throughout the flow path so that each volume element of the reaction mixture experiences the same number and duration of thermal incubations (Haff, column 10, lines 21-38).
Response to Arguments
Applicant's arguments filed 3/26/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Kornilovich does not teach a microfluidic channel directly between and fluidically coupling a first fluid reservoir with a second fluid reservoir … a controller configured by machine-readable instructions to alternatively activate the plurality of inertial pumps to cause fluid within the microfluidic channel to oscillate back and forth between the first fluid reservoir and the second fluid reservoir fluidically coupled by the microfluidic channel” is not found persuasive. As shown above in the annotated figure the channel is considered to be all of the structure between items 202 and 210 and therefore is directly connected to the first and second fluid reservoir. Further, Kornilovich teaches a controller of the parallel PCR architecture so that the controller can implement different cycling protocols with respect to each of the N linear PCR processes such that each process can have a different number of temperature cycles, a different mixture flow rate, different amounts of time per PCR reaction chamber, and different temperatures within the PCR reaction chambers and based upon this teaching one of ordinary skill in the art would have programmed the controller to operate as described in the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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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.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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