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 Arguments
Applicant's arguments filed 9/22/2025 have been fully considered and they are persuasive.
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
In response to the Applicant’s assertion that due to the mischaracterization of their arguments filed previously, the response lacks a substantive rebuttal to the specific distinctions drawn by the Applicant between the claimed invention and the prior art.
In response to this, the Examiner respectfully agrees and places a further discussion of the rejection and the response to the Remarks filed on 4/29/2025 in the action below.
Applicant’s arguments, see Pages 5-9, filed on 4/29/2025, have been fully considered, but they are not persuasive.
On Pages 5-7 of the Remarks, the Applicant argues that the person of ordinary skill in the art would not be motivated to mix a reagent introduced via the inlet and outlet with a cell from the central channel as suggested because the reference instead teaches to maintain "permanently different compositions" in the inlet/outlet and the main channel.
In response to this argument, the Examiner respectfully disagrees. The modification of Sohn et al. to include the implementation of a secondary inlet and outlet of Renaud et al. would allow for the introduction of fluid into the main channel, thus altering the fluid composition of the main channel due to fluid interactions at the constriction. The composition within the main channel of Sohn et al. would be permanently different as was identified by the Applicant on Page 6 of the Office Action because different fluid is being introduced by the fluid inlet and outlet by the modification of Renaud et al. for fluid operations, but the fluid would be mixed within the main channel. While there is not extensive mixing through the channel, the introduction of the secondary fluid allows for an altering of the behavior of the cell within the channel (see [0347] in Renaud), which is inherently what mixing does within a solution.
Additionally, the Applicant argues that combination of references as proposed in the Office Action does not teach or suggest the claim limitation that "a fluid to be analyzed is passed through an analyzing region before contacting any other fluid." Thusly, the proposed modification does not teach or suggest the claimed invention.
However, in response to this argument, the Examiner respectfully disagrees. The microfluidic device of Sohn et al. comprises electrodes for sensing of the fluid properties in Reservoir 1, the constriction, and the second reservoir, which means that there would be analysis of the fluid prior to introduction of the second fluid within the second reservoir (see Fig. 6, [0060] – [0066], and [0112]- [0113]).
In response to the Applicant asserting that t Renaud et al. teaches away from the instant claim limitation "and a second height pattern greater than the first height pattern corresponds to a second area for a second fluidic volume larger than the first fluidic volume and having a reduced flow impedance." This limitation is being treated by Sohn et al. as the second area is drawn to Reservoir 2 of Sohn et al.
In response to applicant's arguments on Page 7 against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Specifically, the Applicant asserts that is established law that if a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification. See, e.g., MPEP 2143.01.
However, the Examiner respectfully disagrees as Sohn et al. teaches that wide range of suitable sizes of inlets and outlets are possible, see [0053]. Therefore, the invention is not limited by the size of the inlet and outlets providing fluid to the system and it would have a negligible impact on the readings of the system as a person possessing ordinary skill in the art would have recognized the need to alter other dimensions of the microfluidic chip to obtain experimental results, see [0052] – [0054] in Sohn et al.
In response to applicant's argument that Renaud et al. teaches away from the instant claim limitation "and a second height pattern greater than the first height pattern corresponds to a second area for a second fluidic volume larger than the first fluidic volume and having a reduced flow impedance,” the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Status of Objections and Rejections
The rejection of claims 1, 3-7, 9, 23-27 under 35 USC 103 as being unpatentable over Sohn et al. (US 2002/0140414) in view of Renaud et al. (US 2010/0006441) stands and is maintained below.
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.
Claims 1, 3-7, 9, 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sohn et al. (US 2002/0140414) in view of Renaud (US 2010/0006441).
Regarding claim 1, Sohn et al. teaches a microfluidic cartridge (referred to as a device for microfluidics, see Abstract and [0015]), comprising: a molded polymer bonded to a flat surface (referred to as the elastomeric cap 5 (molded polymer) that is bonded to a substrate 4 (flat surface), see Fig. 2 and [0045]- [0046], where the elastomeric cap 5 is made from molded PDMS, or molded polymer, see [0075]), wherein the molded polymer comprises one or more openings for connecting to fluidic volumes (the elastomeric cap 5 (molded polymer) comprises an inlet (opening) for accepting a liquid medium M (fluidic volumes), see [0053]), and wherein the molded polymer includes patterns with different heights in different areas to yield a microfluidic circuit with different fluidic volumes in different areas (the elastomeric cap 5 (molded polymer) comprises reservoirs 1 and 2, and conduit 3 (patterns) that have different depths respective to each other, see Fig. 2, [0052], and [0056]- [0058]),
wherein a first height pattern corresponds to a first area having a first flow impedance (the first reservoir 1 has a pattern that tapers toward the conduit 3 and has an impedance based on the flow of particles, see Fig. 2, [0012], and [0051]) and a second height pattern greater than the first height pattern corresponds to a second area for a second fluidic volume larger than the first fluidic volume and having a reduced flow impedance (the second reservoir 2 widens and is therefore greater than the first reservoir 1 pattern and has a larger volume, see Fig. 2, wherein the flow current increases to the second reservoir, meaning the impedance decreases, see [0033] and [0061]), wherein a fluid to be analyzed is passed through an analyzing region before contacting any other fluid (the liquid medium passes through a sensor region prior to separation by another fluid or electrical signal, see [0112]- [0113]).
However, Sohn does not teach that the second area comprises a fluid in port and a fluid out port.
Conversely, in the analogous art of microfluidic platforms for impedance sensing within a conduit, Renaud et al. teaches a microfluidic cartridge (1900) with a second area comprising a fluid in port and a fluid out port (V1 with inlet and outlet, see Fig. 1900 and [0145]). 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 second area of the microfluidic device of Sohn et al. to include the inlet and outlet as shown by Renaud et al. to supply a reagent to the second area for further analysis within a microfluidic platform; additionally Sohn et al. teaches toward the modification of the reservoirs to include an inlet and outlet to facilitate fluid communication, see [0053]-[0054].
There, 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 second area of the Coulter counter of Sohn et al. to allow a cell that has passed from the first area to be exposed to a separate reagent within the second area that has been introduced by the inlet and outlet of Renaud et al. (see [0145] in Renaud). The modification of the second area of Sohn et al. to include the inlet and outlet of Renaud et al. would have yielding the reasonable expectation of successfully facilitating the fluid introduction to a separate area of a microfluidic device for carrying out fluid operations.
Regarding the limitation of “a first height pattern corresponds to a first area having a first flow impedance and a second height pattern greater than the first height pattern corresponds to a second area having a reduced flow impedance,” it is considered a recitation of functional language regarding the intended use of the claimed invention and 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 of having a flow impedance, then it meets the claim. In the instant case, because the height patterns are altered, they alter the fluid impedance values based on the fluid flow characteristics along the molded substrate.
Regarding claim 3, Sohn et al. teaches the microfluidic cartridge of claim l, wherein the flat surface further comprises one or more electrodes (the substrate 4 (flat surface) contains at least one electrode, see Fig. 2 and [0016]).
Regarding claim 4, Sohn et al. teaches the microfluidic cartridge of claim l, wherein the one or more openings provide gas and/or fluid connections (the inlet (opening) accepts fluid from outside the device, see [0015] and [0053]).
Regarding claim 5, Sohn et al. teaches the microfluidic cartridge of claim l, wherein the molded polymer is an organic molded polymer (the elastomeric cap 5 (molded polymer) is constructed from PDMS or PVC which are organic polymers according to the instant application, see [0038]- [0039]) .
Regarding claim 6, Sohn et al. teaches the microfluidic cartridge of claim l, wherein the flat surface comprises a glass surface (the substrate 4 (flat surface) is constructed of glass, see [0036]).
Regarding claim 7, Sohn et al. teaches the microfluidic cartridge of claim l, wherein the one or more openings are adapted to introduce fluid to the cartridge prior to loading the cartridge in a connected instrument (the inlet (opening) accepts fluid that is to be analyzed prior to the electrodes being connected to the signal generator and signal detector (connected instrument), see [0063]).
Regarding claim 9, Sohn et al. teaches the microfluidic cartridge of claim l, wherein the microfluidic cartridge is adapted to permit multiple uses of the cartridge with the same or with different samples (the device (cartridge) can be reused many times, see [0086], where the sample can comprise a plurality of particles for analysis (different samples), see [0120]).
Regarding claim 23, modified Sohn et al. teaches the microfluidic cartridge of claim l, wherein the molded polymer (elastomeric cap) comprises a nanoconstriction (referred to as the narrowing between reservoirs 1 and 2, see Fig. 5) opposite a fluid resistor (referred to as the widening of the reservoir, see Fig. 5, located opposite to the constriction) and wherein a volume of fluid contacted through the fluidic resistor or a volume of fluid contacted through the nanoconstriction are made from a height pattern larger than the height pattern of the fluidic resistor or the nanoconstriction to reduce flow impedance (the fluid that passes through the constriction is made to pass through a section that is larger than the nanoconstriction and fluid resistor portions within the reservoirs 1 and 2, see Fig. 5, [0054], and [0056]).
Regarding claim 24, modified Sohn et al. teaches the microfluidic cartridge of claim l, wherein larger volumes of fluid are moved into, through, or out of sections of the microfluidic cartridge having larger height patterns to reduce flow impedance (the sample moves to the fluid resistor portion where current is injected into the fluid medium and impedance is decreased, see Fig. 5, [0033], and [0061]) and smaller volumes of fluid are moved into, through, or out of sections of the microfluidic cartridge having smaller height patterns to increase high flow impedance (small amounts of fluid are moved into the nanoconstriction to lower current and therefore increase impedance, see [0033], [0061], and [0075]).
Regarding claim 25, modified Sohn et al. teaches the microfluidic cartridge of claim l, wherein the molded polymer includes patterns with at least three thickness dimensions (the elastomeric cap 5 (molded polymer) has height, width, and length dimensions, see [0056]- [0056]).
Regarding claim 26, modified Sohn et al. teaches the microfluidic cartridge of claim l, wherein the molded polymer comprises a nanoconstriction opposite a fluid resistor and an analyte in port connected to an analyte waste port through a height pattern larger than the height pattern of the fluidic resistor or the nanoconstriction to reduce flow impedance therein (the elastomeric cap 5 creates a constriction opposite the fluid resistor portion, see Fig. 5, and the inlet (analyte in port) is connected to an outlet (analyte waste port) where the height of the outlet is taller than the constriction, see Fig. 5 and [0043]).
Regarding claim 27, modified Sohn et al. teaches the microfluidic cartridge of claim 26, wherein filling of the analyte in port is separate from fluid volumes contacted only through the fluidic resistor or the nanoconstriction (the liquid medium from the inlet is separate from the liquid medium in the second reservoir 2 after the constriction, see Fig. 5, [0034], and [0116]).
Regarding claim 28, modified Sohn et al. teaches the microfluidic cartridge of claim 1, but does not teach that the microfluidic circuit comprises two or more second areas.
However, the analogous art of Renaud et al. teaches a microfluidic system wherein the microfluidic circuit (Fig. 1900) comprises two or more second areas (V1-V5). 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 microfluidic device of Sohn et al. to include the plurality of second areas as exemplified by Renaud et al. for the benefit of providing different areas with different impedances that perform different functions, or store different reagents for exposure to a cell located within the microfluidic device (see [0145] in Renaud).
A person possessing ordinary skill in the art would have been motivated before the effective filing date of the instant application to have modified the microfluidic device of Sohn et al. to include the plurality of second areas as shown by Renaud et al. for the benefit of providing different fluid compositions within a microfluidic device that allows for different fluidic operations such as the pickup of metabolites or exposing a cell to a reagent (see [0145] in Renaud). Modifying the microfluidic device of Sohn et al. to include the plurality of second areas as shown by Renaud et al. would have had the reasonable expectation of successfully facilitating a plurality of fluid operations within a microfluidic platform, including fluid introduction or fluid separation.
Regarding claim 29, modified Sohn et al. teaches a device comprising a second area, but does not teach that the second areas each comprise a fluid in and a fluid out port.
However, the analogous art of Renaud et al. teaches a microfluidic cartridge (1900) with second areas comprising a fluid in port and a fluid out port (V1-V5 comprise inlet and outlet, see Fig. 1900 and [0145]). 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 second areas of the microfluidic device of Sohn et al. to include the inlet and outlet as shown by Renaud et al. to supply a plurality of reagents to each second area for further analysis within a microfluidic platform.
A person possessing ordinary skill in the art would have been motivated before the effective filing date of the instant application to have modified the second area of the Coulter counter of Sohn et al. to allow a cell that has passed from the first area to be exposed to a separate reagent within the second area that has been introduced by the inlet and outlet of Renaud et al. (see [0145] in Renaud). The modification of the second area of Sohn et al. to include the inlet and outlet of Renaud et al. would have yielding the reasonable expectation of successfully facilitating the fluid introduction to a separate area of a microfluidic device for carrying out fluid operations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Connor et al. (US 6561208 B1) also teaches a device with two different areas with two different impedances that act differently upon reacting with different fluids, see Example 4.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758