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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 30, 2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application (has PRO 62260944, filed on 30 November 2015; has PRO 62338074, filed on 18 May 2016; CON of 15363908, filed on 29 November 2016; CON of 16688141, filed on 19 November 2019; CON of 16983293, filed on 03 August 2020) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claim 34 objected to because of the following informalities:
The phrase “configured to receive an electric field from a first electrode” should be corrected to read “configured to receive an electrical potential from a first electrode” for technical accuracy.
Claim 37 objected to because of the following informalities:
The phrase “a separated analyte[[s]] mixture” should be corrected to read “a separated analyte mixture” for proper grammar.
Claim 40 objected to because of the following informalities:
The phrases “the separated analyte[[s]] mixture” and “a mobilized separated analyte[[s]] mixture” should be corrected to read “the separated analyte mixture” and “a mobilized separated analyte mixture,” respectively, for proper grammar.
Claim 41 objected to because of the following informalities:
The phrase “the separated analyte[[s]] mixture” should be corrected to read “the separated analyte mixture” for proper grammar.
Claim 45 objected to because of the following informalities:
The phrase “in an electric field of the first fluid channel” should be corrected to read “within the electric field applied to the first fluid channel” for clarity.
Claim 47 objected to because of the following informalities:
The phrase “the mobilized separated analyte[[s]] mixture” should be corrected to read “the mobilized separated analyte mixture” for proper grammar.
Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 34–35 and 37–49 are rejected under 35 U.S.C. 103 as being unpatentable over ZHENG et al. (“Microfabricated Devices for Capillary Electrophoresis-Electrospray Mass Spectrometry” Analytical Chemistry. 71. 1999. Hereinafter ZHENG).
Regarding Claims 34–35, ZHENG discloses a microfluidic device configured for electrophoretic separation and electrospray mass spectrometry (Abstract; Pg. 3258).
In Microdevice with the Integrated Nebulizer - Fabrication, the microfluidic device of Figure 2 includes etched channels for sample, buffer, and gas flow formed in a single glass substrate, and a glass cover plate with drilled wells thermally bonded to the substrate. The device comprises a separation channel (i.e., a first fluid channel), an auxiliary fluid channel (i.e., a second fluid channel) intersecting the separation channel, and two gas channels flanking the outlet. The electrospray exit port (i.e., an orifice) is formed by cutting the chip using a dicing saw, and the sheath gas is supplied from a nitrogen gas tank with rubber O-rings sealing the gas sheath channel inlet (Experimental Section B; Pg. 3260).
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Figure 2 of ZHENG et al.
In Microdevice with External Transfer Capillary, the pumping action at the mass spectrometer sampling orifice lowers the pressure in the enclosed electrospray region, creating a pressure drop that initiates flow of the analyzed liquid through the electrospray needle without an external pump (Results and Discussion, Pg. 3261).
In Microdevice with an Integrated Nebulizer, the sample deposited in the sample inlet port could be injected as a zone of variable length by electromigration. Two gas channels in a V-shape arrangement merge at the electrospray exit port and deliver nitrogen gas to induce suction and dispersion of the auxiliary liquid at the electrospray exit port, and the gas flow aids evaporation of the electrosprayed droplets (Results and Discussion, Pg. 3262).
Based on this disclosure, the pressure drop acts through the connected transfer capillary and separation channel and mobilizes the analyte mixture in the first fluid channel toward the orifice. It was also well known in the art to apply external pressure to drive liquid through a microfluidic separation channel. Based on the desired mobilization rate, a person skilled in the art would have used external pressure as an alternative to the disclosed pressure drop to control movement of the analyte mixture toward the electrospray exit port.
Accordingly, as shown in Figure 2, the BGE reservoir corresponds to the claimed first reservoir, and the auxiliary-liquid reservoir corresponds to the claimed second reservoir. It was well known in the art that isoelectric focusing is a mode of capillary electrophoresis using an anolyte at an anode and a catholyte at a cathode to establish a pH gradient under an electric field. Based on the desired electrophoretic separation mode, a person skilled in the art would have provided the BGE reservoir with an anolyte, the auxiliary-liquid reservoir with a catholyte, and respective electrodes to perform isoelectric focusing (In re Schreiber, 128 F.3d 1473, 1997).
The microfluidic device is formed in a glass substrate with a thermally bonded glass cover plate, and Figure 2 illustrates the channels and wells as visible features of the glass chip. This glass construction provides a transparent portion through which the channel region can be optically imaged (In re Schreiber, 128 F.3d 1473, 1997).
Regarding Claim 37, ZHENG makes obvious a microfluidic device of Claim 34. Figure 3 of ZHENG illustrates that the BGE reservoir is electrically connected to a high-voltage power supply (Microdevice with External Transfer Capillary; Pg. 3261). As discussed in the rejection of Claims 34–35, a person skilled in the art would have applied a first electrical field between the anolyte and catholyte reservoirs to effect isoelectric focusing, thereby separating the analyte mixture and yielding a separated analytes mixture.
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Figure 3 of ZHENG et al.
Regarding Claims 38, 39 and 41, ZHENG makes obvious a microfluidic device of Claim 37. Figure 2 of ZHENG illustrates that the device is formed from a glass substrate with a thermally bonded glass cover plate (Experimental Section B; Pg. 3260). The glass construction inherently allows imaging of the separation of the analyte mixture and the focused analyte mixture through the transparent portion (In re Schreiber, 128 F.3d 1473, 1997).
Regarding Claim 40, ZHENG makes obvious a microfluidic device of Claim 37. Figure 2 of ZHENG illustrates the BGE reservoir and auxiliary-liquid reservoir positioned at opposite ends of the separation channel, between which an electric voltage is applied to conduct CE separation (Results and Discussion; Pg. 3262). As discussed in the rejection of Claims 34–35, the negative electrode in the auxiliary-liquid reservoir, together with the positive electrode in the BGE reservoir, provides a second electrical field across the separation channel to electrokinetically mobilize the separated analytes mixture to yield a mobilized separated analytes mixture.
Regarding Claim 42, ZHENG makes obvious a microfluidic device of Claim 34. As discussed in the rejection of Claims 34–35, the auxiliary-liquid reservoir corresponds to the second reservoir containing the catholyte, and the auxiliary-liquid channel corresponds to the second fluid channel and inherently introduces the catholyte into the separated analyte mixture.
Regarding Claims 43–46, ZHENG makes obvious a microfluidic device of Claim 34. Figure 2 of ZHENG illustrates that the separation channel and the auxiliary-liquid channel intersect at a confluence region downstream of the separation channel (i.e., the first fluid channel) and in fluid communication with the auxiliary-liquid channel (i.e., the second fluid channel), and the confluence region is in line with the separation channel and the electrospray exit (i.e., the orifice; Experimental Section B; Pg. 3260).
Regarding Claim 47, ZHENG makes obvious a microfluidic device of Claim 40. ZHENG discloses that the interface uses the mass spectrometer sampling orifice to initiate flow of the analyzed liquid through the electrospray needle (Microdevice with External Transfer Capillary; Pg. 3261).
Regarding Claim 48, ZHENG makes obvious a microfluidic device of Claim 47. ZHENG discloses that two gas channels in a V-shape arrangement merge at the electrospray exit port and deliver nitrogen gas to induce suction and dispersion of the auxiliary liquid at the electrospray exit port, and the gas flow aids evaporation of the electrosprayed droplets, which facilitates electrospray ionization (Microdevice with an Integrated Nebulizer; Pg. 3262).
Regarding Claim 49, ZHENG makes obvious a microfluidic device of Claim 34. ZHENG discloses an internal pressure differential source, where the mass spectrometer sampling orifice lowers pressure in the enclosed electrospray region and creates a pressure drop that initiates flow through the device fluid path (Microdevice with External Transfer Capillary; Pg. 3261). As discussed in the rejection of Claims 34–35, a person skilled in the art would have used an external pressure source as an alternative to the disclosed pressure drop to apply pressure in the first fluid channel and control movement of the analyte mixture toward the electrospray exit port.
Response to Arguments
Applicant’s arguments, see Remarks filed April 30, 2026, with respect to the rejections under 35 U.S.C. §§ 102 and 103 have been fully considered. In view of the amendments to the claims, the prior rejections are withdrawn. However, upon further consideration, a new ground of rejection is made under 35 U.S.C. § 103 in view of ZHENG et al.
Conclusion
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/TAK L. CHIU/Examiner, Art Unit 1771
/PREM C SINGH/Supervisory Patent Examiner, Art Unit 1771
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