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 and 3-20 in the reply filed on 01/26/2026 is acknowledged.
Applicant disagrees with the restriction requirement mailed on 10/24/2025. Applicant traverses on the grounds that a single search and examination will cover all claims without placing a burden on the Examiner. The Applicant’s arguments have been fully considered and are not persuasive. The inventions of groups I and II are independent and distinct. Each group has at least one element which causes the searches to diverge. Group I is drawn to a fluidic module, and group II is drawn to a method, the inventions are related as product and process of use.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/20/2023 and 01/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20 are pending with claims 1, 3-20 being examined, claim 2 is deemed withdrawn.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (US 20140190903 A1; hereinafter “Huang”).
Regarding claim 1, Huang teaches a fluidic module (Huang; [0224), comprising:
a first channel (Hung; fig. 18A. 501) comprising a first-channel inlet (Huang; fig. 18A. 502);
a second channel (Huang; fig. 18A. 504) comprising a second-channel outlet (Huang; fig. 18A. 507); and
a membrane positioned between the first and second channels (Huang; fig. 18A. 508), wherein:
the first and second channels are in fluidic communication with each other
through the membrane (Huang; fig. 18A. 183, 184);
the fluidic module is configured such that fluid flowing from the first-channel inlet to the second-channel outlet experiences a substantially constant pressure drop over an area of the membrane (Huang; fig. 5A. 501, 504) and [0239] “the filtrate flow chamber 504 (second channel) may be designed to draw a small amount of flow through each pore, the flow rate through each pore may be designed to be a small fraction” (pressure drop));
a dimension of the first channel perpendicular to the membrane decreases from a portion of the channel proximal to the first-channel inlet to a portion of the channel distal from the first-channel inlet (Huang; fig. 18A. 501, 502); and
a dimension of the second channel perpendicular to the membrane increases from a portion of the channel distal to the second-channel outlet to a portion of the channel proximal to the second-channel outlet (Huang; fig. 18A. 507, 509).
Regarding claim 4, Huang teaches the fluidic module as in claim 1 (see above), wherein the dimension of the first channel perpendicular to the membrane is a height of the first channel (Huang; [0227] “pillar 505 may have heights similar to their widths”).
Regarding claim 5, Huang teaches the fluidic module as in claim 1 (see above), wherein the dimension of the second channel perpendicular to the membrane is a depth of second channel (Huang; [0227] “pillar 505 may have heights similar to their widths”).
Regarding claim 6, Huang teaches the fluidic module as in claim 1 (see above), wherein at least a portion of the fluid does not flow across the membrane (Huang; [0008] “retentate particles are retained by the filter”).
Regarding claim 7, Huang teaches the fluidic module as in claim 1 (see above), wherein the first channel further comprises a first-channel outlet, and wherein at least a portion of the fluid flows out the first-channel outlet (Huang; fig. 18A. 501, 503 and [0225]).
Regarding claim 8, Huang teaches the fluidic module as in claim 1 (see above) (see above), wherein the membrane is configured for cell clarification, virus removal, affinity chromatography, protein A purification, ion exchange chromatography, exosome purification, hydrophobic interaction chromatography, diafiltration, and/or ultrafiltration.
Huang teaches a membrane (see above). This claim merely recites an intended use of the claimed invention. The membrane in Huang is fully capable of filtering and separating particles since Huang teaches every necessary component. Thus, Huang meets the limitations of the claim. See MPEP 2114.
Regarding claim 9, Huang teaches the fluidic module as in claim 1 (see above), wherein the fluid comprises a species (Huang; [008 “blood cells”]) to which the membrane is configured to bind (Huang; [0027]).
Regarding claim 10, Huang teaches the fluidic module as in claim 9 (see above), wherein the membrane is configured to elute the bound species (Huang; [0238] “label and wash (elute) cells in a continuous flow fashion”).
Regarding claim 11, Huang teaches the fluidic module as in claim 1 (see above), wherein the membrane is suitable for use in flow-through mode (Huang; [0146]).
Regarding claim 12, Huang teaches the fluidic module as in claim 1 (see above), wherein the fluid comprises a species to which the membrane is impermeable (Huang; [0008] “retentate particles are retained by the filter”).
Regarding claim 13, Huang teaches the fluidic module as in claim 12 (see above), wherein the species deposits on the membrane when the fluid flows through the membrane (Huang; [0008] “particles are retained by the filter, and a filtrate is passed through the filter disposed between first chamber to the outlet of the second chamber”).
Regarding claim 14, Huang teaches the fluidic module as in claim 12 (see above), wherein an areal density of the species bound to and/or deposited on the membrane is substantially constant across the membrane (Huang; [0046]-[0049] teaches the fluidic module flows fluid through all the pores (constantly across the membrane), wherein the flow of fluid is constant (Huang; [0047]).
Regarding claim 15, Huang teaches the fluidic module as in claim 1 (see above), wherein a flow rate through the membrane is substantially constant across the membrane (Huang; [0082] “passing the sample through the microfluidic flow chambers of the filtration device, creating laminar flow conditions”)..
Regarding claim 16, Huang teaches the fluidic module as in claim 1 (see above), wherein the first-channel inlet is configured to receive fluid from a bioreactor. Huang teaches a first-channel inlet (see above) and a fluid (biological sample (see above).
Huang teaches a first-channel inlet (see above) and a fluid (biological sample (see above). This claim merely recites an intended use of the claimed invention. The first-channel inlet in Huang is fully capable of receiving fluid from a bioreactor since Huang teaches every necessary component. Thus, Huang meets the limitations of the claim. See MPEP 2114.
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.
Claims 3, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 20140190903 A1; hereinafter “Huang”) in view of McGuiness et al. (US 20180015457 A1; hereinafter “McGuiness”).
Regarding claim 3, Huang teaches a fluidic module (Huang; [0224), comprising:
a first channel (Hung; fig. 18A. 501) comprising a first-channel inlet (Huang; fig. 18A. 502) and a first-channel outlet (Huang; fig. 18A. 503);
a second channel (Huang; fig18A. 504) comprising a second-channel outlet (Huang; fig. 18A. 507); and
a membrane positioned between the first and second channels (Huang; fig. 18A. 508), wherein:
the first and second channels are in fluidic communication with each other
through the membrane (Huang; fig. 18A. 503, 504 and [0225]);
a dimension of the first channel perpendicular to the membrane decreases from a
portion of the channel proximal to the first-channel inlet to a portion of the channel distal from the first-channel inlet (Huang; fig. 18A. 501, 502); and
a dimension of the second channel perpendicular to the membrane increases from a portion of the channel distal to the second-channel outlet to a portion of the channel proximal to the second-channel outlet (Huang; fig. 18A. 507, 509).
Huang fails to teach the first-channel outlet is in fluidic communication with the first-channel inlet through a pathway other than the first channel.
However, McGuiness teaches the analogous art of a microfluidic diagnostic device (McGuiness; Abstract) that include a first-channel inlet (McGuiness; fig. 2A. 205) and a first-channel outlet (McGuiness; fig. 2A arrow coming out of channel 210) wherein the first-channel outlet is in fluidic communication with the first-channel inlet through a pathway other than the first channel (McGuiness; fig. 2A arrows, and [0026] “channel inlet and the microfluidic channel cooperate together to recirculate a fluid”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Huang’s first-channel outlet to be in fluidic communication with the first-channel inlet through a pathway other than the first channel as taught by McGuiness because McGuiness teaches a microfluidic diagnostic device (McGuiness; Abstract) that include a first-channel inlet (McGuiness; fig. 2A. 205) and a first-channel outlet (McGuiness; fig. 2A arrow coming out of channel 210) wherein the first-channel outlet is in fluidic communication with the first-channel inlet through a pathway other than the first channel (McGuiness; fig. 2A arrows, and [0026] “channel inlet and the microfluidic channel cooperate together to recirculate a fluid”).
The modification allows to recirculate the fluid sample to purify the fluid sample.
Regarding claim 17, Huang teaches the fluidic module as in claim 1 (see above) to include a first-channel inlet and a first-channel outlet (see above).
Huang fails to teach wherein the first-channel inlet is configured to receive fluid from a first-channel outlet of a second fluidic module.
However, McGuiness teaches the analogous art of a microfluidic diagnostic device (McGuiness; Abstract) that include a first-channel inlet (McGuiness; fig. 2A. 205) and a first-channel outlet (McGuiness; fig. 2A arrow coming out of channel 210) and a second fluidic module (McGuiness; fig. 3. 215) wherein the first-channel inlet is configured to receive fluid from a first-channel outlet of a second fluidic module (McGuiness; fig. 3 arrows, and [0006]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Huang’s first-channel inlet to receive fluid from a first channel outlet of a second fluidic module as taught by McGuiness because McGuiness teaches a microfluidic diagnostic device (McGuiness; Abstract) that include a first-channel inlet (McGuiness; fig. 2A. 205) and a first-channel outlet (McGuiness; fig. 2A arrow coming out of channel 210) and a second fluidic module (McGuiness; fig. 3. 215) wherein the first-channel inlet is configured to receive fluid from a first-channel outlet of a second fluidic module (McGuiness; fig. 3 arrows, and [0006]).
The modification allows to recirculate the fluid sample to purify the fluid sample.
Regarding claim 19, Huang teaches the fluidic module as in claim 1 (see above) to include a second-channel outlet and a first-channel inlet (see above).
Huang fails to teach wherein the second-channel outlet is configured to provide fluid to a first-channel inlet of a third fluidic module.
However, McGuiness teaches the analogous art of a microfluidic diagnostic device (McGuiness; Abstract) that include a second-channel outlet (McGuiness; fig. 3 arrow coming out of channel 210) and a first-channel inlet (McGuiness; 3. 205) and a second fluidic module (McGuiness; fig. 3. 215) wherein the second-channel outlet is configured to provide fluid to a first-channel inlet of a third module (McGuiness; fig. 3. 215 and [0035] “any number of pumps (modules) may be implemented”, “the first pump 215 is activated and any remaining pumps may be activated in sequential activation order”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Huang’s second-channel outlet to provide fluid to a first-channel inlet of a third module as taught by McGuiness because McGuiness teaches a microfluidic diagnostic device (McGuiness; Abstract) that include a second-channel outlet (McGuiness; fig. 3 arrow coming out of channel 210) and a first-channel inlet (McGuiness; 3. 205) and a second fluidic module (McGuiness; fig. 3. 215) wherein the second-channel outlet is configured to provide fluid to a first-channel inlet of a third module (McGuiness; fig. 3. 215 and [0035] “any number of pumps (modules) may be implemented”, “the first pump 215 is activated and any remaining pumps may be activated in sequential activation order”).
The modification of adding a third module allows for purification of the sample.
Regarding claim 20, Huang teaches the fluidic module as in claim 1 (see above) to include a second-channel outlet and a first-channel inlet (see above).
Huang fails to teach wherein the second-channel outlet is configured to provide fluid to the first-channel inlet.
However, McGuiness teaches the analogous art of a microfluidic diagnostic device (McGuiness; Abstract) that includes a second-channel outlet (McGuiness; fig. 3 arrows leaving the sensor 220) and a first-channel inlet (McGuiness; fig. 3. 205) wherein the second-channel outlet is configured to provide fluid to the first-channel inlet (McGuiness; [0035] “the microfluidic diagnostic chip (MDC) analyzing an analyte recirculating the fluid”, and fig. 3. 205 and arrows leaving the sensor 220).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Huang’s second-channel outlet to provide fluid to the first-channel inlet as taught by McGuiness because McGuiness teaches a microfluidic diagnostic device (McGuiness; Abstract) that includes a second-channel outlet (McGuiness; fig. 3 arrows leaving the sensor 220) and a first-channel inlet (McGuiness; fig. 3. 205) wherein the second-channel outlet is configured to provide fluid to the first-channel inlet (McGuiness; [0035] “the microfluidic diagnostic chip (MDC) analyzing an analyte recirculating the fluid”, and fig. 3. 205 and arrows leaving the sensor 220).
The modification allows for purification of the sample.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798