Smith
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
Applicant’s amendment filed on 12/10/25 has been entered. Claims 1-4, 7-8, and 11 are pending and examined herein. Applicant’s amendment and remarks have overcome each and every rejection under 112 set forth in Office Action mailed on 09/16/25.
Response to Arguments
Applicant's arguments filed 12/10/25 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., multi-layer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the amendment, the term “film member” is followed up with functional language “to block the at least one flow channel from being exposed to an external space”. However, according to rest of the claim, the claimed function of the film member is only achieved when the film member is used with the opening and closing member. In addition, the only recited structure of the film member is an air flow hole. As such, under broadest reasonable interpretation, an air flow hole provided on the core member is sufficient to be interpreted as “film member”.
To expedite prosecution, Examiners encouraged applicant to incorporate additional structural limitations to the core or the film member such as the limitation “wherein the body includes a core member including a plurality of first guide flow channels for guiding a flow of fluid in a vertical direction; and a film member configured to be attached to an outer surface of the core member and allow the plurality of first guide flow channels to communicate with each other.” of para. [0028] of specification.
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.
Claim(s) 1-4, 7-8, and 11 is rejected under 35 U.S.C. 103 as being unpatentable over Owens (US 20180078936 A1) in view of Beebe (US 20030136451 A1) and Zuchowska (A549 and MRC-5 cell aggregation in a microfluidic Lab-on-a-chip system, 2017) as cited in the previous Office Action.
Regarding claim 1, Owens discloses a modular fluidic chip comprising:
a body having at least one flow channel (Path 4342) formed in an inside thereof (modular block 4300, Figure 9B),
wherein the at least one flow channel includes a first flow channel and a second flow channel that have different heights (See annotated Figure 9B),
wherein the body includes a core member (modular block 4300, Fig. 9B)
Owens does not disclose:
the body includes a film member attached to an outer surface of the core member, wherein the film member is provided with an air flow hole allowing the at least one flow channel and an external space to communicate with each other.
an opening and closing member configured to be attached to the body and open and close the air flow hole,
wherein the opening and closing member includes a hydrophobic material and a hydrophilic material, and is formed in a stacked form in which the hydrophobic material is provided on one surface thereof and the hydrophilic material is provided on the other surface thereof, and is configured to remove bubbles from the fluid flow through the at least one flow channel
In an analogous art, Beebe disclose a microfluidic device comprising:
a body (12, Figure 1-2);
a channel in the body (26, Figure 3) and an air flow hole allowing the at least one flow channel and an external space to communicate with each other (opening 28, Figure 3; Paragraph 38).
It is known in the art to include vent hole in preparation of the microfluidic device in order to allow air to escape during device preparation (Thus “Vent” hole). In another analogous art, Zuchowska discloses a microfluidic chip for studying cancer cells comprising an inlet, a vent hole, and outlets (Figure 1(c), I-inlet, II-vent hole, III-outlets). Zuchowska discloses residual air bubbles may damage cell culture during the study of cells inside a microfluidic device (II. Materials and Methods, A. Microsystem design and fabrication; pg. 2-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporate a vent hole/film member/air hole based on Beebe connecting to the at least one flow channel of Owens to derive the claimed invention. Incorporating a vent hole allows letting out of unwanted air during device preparation and prevent damage caused by air bubble when working with cells (Zuchowska, II. Materials and Methods, A. Microsystem design and fabrication; pg. 2-3).
Regarding the limitation of opening and closing member, within the same art, Beebe discloses a configuration in which an opening and closing member is used to be attached to the body and open and close the air flow hole (cover 48, Figure 10). Zuchowska discloses the venting system operation in which vent hole is initially opened to allow air to escape and then closed in order for cells to flow through (Figure 2, B. The venting system operation). Therefore, it would have been obvious to one of ordinary skill in the art to further modify Modified Owens by incorporating a cover to the vent hole based on Zuchowska’s venting operation (Figure 2), doing so prevent unwanted flow to the vent hole (Beebe, Paragraph 42). Furthermore, the operation of removing or inserting the opening and closing member (after the modification of Owens with Bebe and Zuchowska) would have taught the limitation “configured to remove bubbles from the fluid flowing through the at least one flow channel” when the member is removed to allow the vent hole to be open to atmosphere (Zuchowska, II. Materials and Methods, A. Microsystem design and fabrication; pg. 2-3).
Modified Owens does not disclose the configuration in which the opening and closing member is formed in a stacked form in which the hydrophobic material is provided on one surface thereof and the hydrophilic material is provided on the other surface thereof.
Owens discloses the material of the entirety of the modular block can be PTFE or PET (Paragraph 145). Specifically, Owens disclose that PTFE is a suitable sealing or gasket material for its chemical compatibility to the specific working fluids and prevents leakage (however, this depends on the working fluids (water vs silicone oil) (Paragraph 192). As such, it would have been obvious to one of ordinary skill in the art to have built the opening and closing member using the PFTE for the device of Modified Owens for working with hydrophilic fluid.
Owens also discloses the material of the entirety of the modular block can be ABS (Paragraph 145). Specifically, Owens discloses that ABS can be used in solvent welding in order to seal off inlet/outlet apertures to prevent unwanted leakage (Paragraph 193). As such, it would have been obvious to one of ordinary skill in the art to have also built the opening and closing member using the same material as device of Modified Owens such as using an ABS cover from hydrophobic fluid system to prevent fluid leakage (Paragraph 192-193).
Owens does not disclose the stacking of the two contrasting materials in the opening and closing member. Rather Owens suggested their applicability individually. It is examiner’s position that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination (MPEP 2144.07). Furthermore, as shown in MPEP 2144.04, V, B, “the use of a one-piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice”. Without showing the insight was contrary to the understandings and expectations of the art, it would have been obvious to one of ordinary skill in the art to have constructed the closing and opening member in a stacked form with material such as PTFE and ABS as claimed to eliminate the need to have two separate opening and closing members with one for operating with hydrophobic fluid and other for hydrophilic fluid.
Regarding claim 2, Modified Owens discloses the first flow channel is formed at a position relatively lower than that of the second flow channel and the first flow channel and the second flow channel are configured to guide fluid flowing therein in a horizontal direction (See annotated Figure 9B).
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Regarding claim 3 and 4, Modified Owens discloses the claimed invention as discussed above in claim 1. Owens discloses a third flow channel configured to guide a flow of fluid in a vertical direction, a fourth flow channel configured to guide the fluid flowing therein in the horizontal direction (See annotated Figure 9B below). The configuration of 9B does not discloses a chamber configured to store and stabilize the fluid introduced from one side thereof, therein, and discharge the fluid to the other side thereof; and the fourth flow channel formed at a position relatively lower than that of the first flow channel or the chamber.
Within the same art, Owens disclose another configuration in which the modular fluidic chip comprises a flow path configured to guide the flow of a fluid upward; an incubation chamber (2655) (interpreted as claimed chamber) for accommodating the fluid introduced from one side; and a second outlet formed at a position relatively lower than the inlet or the chamber and configured to guide the fluid flowing therein in the horizontal direction (Paragraph 223 and figure 14b).
It is also known in the field of the art that difference in channel height contributes to pressure difference due to gravitational force, thus affecting flow parameters (velocity, flow rate, etc.).
Based on other configurations taught by Owens, it would have been obvious to one of ordinary skill in the art to implement a fluid chamber configured to transport fluid from one end to another between the third and the fourth channel. Doing so allows for specific application such as colloidal separation or separation processes with magnetic beads (Paragraph 221).
Regarding the limitation about the relative positioning of the fourth channel to that of the chamber, it would have been obvious to one of ordinary skill in the art to positioning the fourth channel lower than the chamber for varying flow pressure and flow rate due to the change in gravitation force.
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Regarding claim 7, Modified Owens discloses the claimed invention as discussed above in claim 1. Neither Owens, Beebee nor Zuchowska explicitly discloses the opening and closing member is formed of a fibrous structure coated with the hydrophilic material on one surface and the hydrophobic material on the other surface. Owens discloses a need of treating hydrophilic material with hydrophobic material during welding and manufacturing process (Paragraph 178). Specifically, Owens discloses that in solvent welding using acetone (hydrophilic), a thin layer of polycarbonate (hydrophobic) was able to seal a surface of the modular brick (Paragraph 193). Therefore, it would have been obvious to a person of ordinary skill in the art to have incorporate the coating/treatment process taught by Owens to the cover layer with both hydrophilic and hydrophobic material, treating a hydrophilic material with hydrophobic material (or vice versa) will make the material hydrophobic/hydrophilic to fit the specific property/permeability of the working fluid (Paragraph 178 and 192). Doing so can be used to seal or prevent fluid leaking (Paragraph 193).
Regarding claim 8, Modified Owens discloses the claimed invention as discussed above in claim 7. Owens discloses the hydrophobic material is PTFE (Paragraph 145).
Regarding claim 11, Modified Owens discloses the claimed invention as discussed above in claim 1. Owens discloses the body is formed integrally through 3D printing processing (Paragraph 152).
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 MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./Examiner, Art Unit 1758 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797