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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 July 2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s amendments and remarks filed 10 July 2025. Claims 1-2, 4, 9, 12-13, 16-18, 21-23, and 25-31 are pending.
Claims 3, 5-8, 10-11, 14-15, 19-20, 24, and 32 are cancelled.
No claims are withdrawn.
No new claims are added.
Claim Objections
Claim 2 is objected to because of the following informalities: The claim recites “chambers 1 and 2” as well as “1st and 2nd chambers” wherein it appears Applicant may intend to introduce the chambers as 1st and 2nd as opposed to the chambers 1 and 2 given Applicant’s overall amendments codifying the chambers as 1st, 2nd, and 3rd. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4, 9, and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 4, the terms “top edge” and “center line” used by the claim are relative terms that render the claim indefinite. One of ordinary skill in the art may have different interpretations of the term top edge depending on the orientation in which the chip is viewed, and one may have different interpretations of the location of the center line depending on which structure of the chip it is related (For example, each chamber may have an individual center line. Further, a rectangular chip could have different center lines depending on which orientation the chip is viewed.). Additionally, Applicant has failed to specify the shape of the chip and the specific edge to which the “top edge” refers. Given a circular chip, one skilled in the art would not be able to positively ascertain what constitutes the top edge. Further, even given a rectangular chip, one skilled in the art could not ascertain which of the four edges constitutes the top edge. The same is true for the center line.
Without a clear objective structural boundary, criteria, or frame of reference specifying to the locations of the terms, it is unclear what falls within the scope of the claim or not. By this, the location of the “reference axis position” is also indefinite given that it is related via the center line and top edge which are themselves relative terms. Further note that “above the chambers” is also relative and having different interpretations depending on the orientation in which the chip is viewed.
Claim 4 recites the limitation "P1". There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the centrifugal microfluidic chip controller". There is insufficient antecedent basis for this limitation in the claim. Claim 28 (on which Claim 30 directly depends) mentions a centrifugal microfluidic chip controller but fails to positively claim this element.
Additionally, Claim 30 recites the kit being assembled and mounted to the centrifugal microfluidic chip controller, but the claim does not positively set forth the choosing of the “one or more cartridge forming elements adapted for coupling” (an option provided by the alternative-type recitation of Claim 28 for adapting the chip to mount onto a centrifugal system), nor the positive mounting of said cartridge forming elements to the respective blade centrifugal microfluidic chip controller; centrifuge blade with a pneumatic slip ring; or articulated centrifuge blade with a pneumatic slip ring.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4, 9, 12-13, 18-19, 21, and 25-31, are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2016/0144363 A1) referred to herein as “Lin” and as evidenced through Duncombe et al. (“Microfluidics: reframing biological enquiry”, Nature Reviews: Molecular Cell Biology, Vol. 16, pages 554-567, 21 August 2015) referred to herein as “Duncombe”.
Regarding Claim 1, Lin teaches a centrifugal microfluidic chip (Fig. 2 shows microfluidic chip 24 mounted to microfluidic platform 20 which rotates about center of rotation 21 to provide a centrifugal force to the microfluidic chip 24.) comprising:
a plurality of microfluidic chambers (Fig. 3C shows various chambers of the microfluidic chip 40C.,including chambers 1, 2, and 3) each having a volume of 0.1 µL to 1 mL (Given that the six metering chambers 451A of Fig. 5C (shown in the context of the full microfluidic chip in Fig. 3C) are described in [0086] as having a capacity of 7 µL, and that the reaction chambers 453A (Fig. 5C) are drawn in Fig. 5C as having the same or similar volume as the reaction chambers 453A, and that the reaction chambers 453A are drawn as the smallest of the microfluidic chambers 420, 410, and 470 in Fig. 3C, the chambers must have a volume of at least about 7 µL. Further, while an upper limit to chamber volumes is not established by Lin, given that microfluidic devices have typical internal volumes of microliters to picolitres, as evidenced by Duncombe, and that [0084] describes a mere 200 µL of sample injected into the injection chamber 410, one of ordinary skill in the art would reasonably conclude that the chambers of the device disclosed by Lin have internal volumes no greater than about 1 mL.),
and a nominal fill line defined with respect to a reference axis position (Applicant does not define a specific criteria or identifiable structure of the device that defines the fill line. Thus, each device defined by Lin has a fill line, and said fill line may exist anywhere within the device or its respective components, and Lin provides a fill line commensurately as claimed for the three chambers – Applicant does not define a specific structure or orientation in space which would describe the location of the “reference axis position” precluded from the arrangement provided in Lin, wherein Lin provides a reference axis as claimed for each of the three chambers);
the plurality of microfluidic chambers including a conditioned chamber, and a 1st, a 2nd, and a 3rd chambers (See the annotated Fig. 3C below.),
a plurality of microfluidic channels interconnecting respective chambers, including channels coupling the conditioned chamber to each of the 1st, 2nd, and 3rd chambers (Fig. 3C shows various channels connecting microfluidic chambers 450, 420, 410, and 470.); a plurality of ports, each port in fluid communication with one or more chambers, including the 1st, 2nd, and 3rd chambers (Fig. 3C shows ports 480.);
wherein one of the chambers is a conditioned chamber, connected via channels to the 1st, 2nd, and 3rd chambers at least one port (Fig. 3C shows process chamber 420, interpreted as the conditioned chamber given that the process chamber is “configured for sample preparation” ([0045]). Further, the process chamber is shown as connecting via channels to all other chambers formed by the chip, as well as to ports 480 via channel 3.), where:
the 1st chamber has a first opening from a port at or above its nominal fill line (While Lin does not explicitly mention a port opening from the injection chamber (chamber 1), given that [0079] describes sample being injected into this chamber, a port must necessarily exist for sample to be injected through and into the chamber. Further, one of ordinary skill in the art would find it an obvious design choice to position the injection port above the fill line to prevent backflow through the port when the chip is centrifugated.), and second opening to a first channel, the first channel connecting the 1st chamber below its nominal fill line to the conditioned chamber (See the annotated Fig. 3B below.);
the 2nd chamber has a second opening to a second channel at or above its nominal fill line, and no opening to any interconnecting channel or port below the nominal fill line, where the second channel includes a path segment that extends closer to the reference axis than any part of the 2nd chamber, and connects the conditioned chamber above its nominal fill line and the 2nd chamber above its nominal fill line, the second channel having no valve, and no capillary flow dimensioned constriction (See the annotated Fig. 3B below.);
the 3rd chamber has, above its nominal fill line, a first opening to a port, and a second opening to a third channel, the third channel connecting the 3rd chamber to the conditioned chamber below the conditioned chamber's nominal fill line (The third channel connects chamber 3 to the conditioned chamber via the second channel (See the annotated Fig. 3B below.).).
Lin does not teach the 2nd chamber having a first opening from a port above the nominal fill line. However, Lin does teach a subsidiary microfluidic element 50 configured to carry a solution or a sample and deliver it to chamber 2 (Fig. 3C and [0058]: “Activation of the drive module causes the solution in the subsidiary microfluidic element 50 to be actuated and moved into the paired detection chamber 450 (chamber 2).”) Given this, a port must necessarily exist in the subsidiary microfluidic element 50 to fill it with reagent solution or sample. Since the subsidiary microfluidic element 50 is located above detection chamber 450, said port must also be located above the fill line of detection chamber 450.
Given that the claimed port and the prior art port of subsidiary microfluidic element 50 preform the same function of delivering reagent or sample to chamber 2, the device having the claimed relative arrangement of parts would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said port – see MPEP 2144.04 (VI)(C).
Regarding Claim 2, Lin teaches a centrifugal microfluidic chip comprising: a plurality of microfluidic chambers each having a volume of 0.1 pL to 1 mL; a plurality of microfluidic channels interconnecting respective chambers; a plurality of ports, each port in fluid communication with one or more chambers; wherein one of the chambers is a conditioned chamber, connected via channels to chambers 1, and 2, where:
The 1st chamber has a first opening from a port above a nominal fill line of the 1st chamber, and a second opening to a first channel, the first channel connecting the 1st chamber closer to an axis distal point of the 1st chamber than its nominal fill line, to the conditioned chamber above the conditioned chamber's nominal fill line;
The 2nd chamber having a second opening to a second channel above the nominal fill line, and no opening to any channel below the nominal fill line; and the second channel includes a path segment that extends closer to a reference axis position for the chip than either the conditioned chamber, the 2nd chamber, and connects to the conditioned chamber, as in Claim 2, and as discussed above regarding Claim 1.
Lin further teaches the 2nd chamber having a spillway opening delimiting a nominal fill line for the 2nd chamber ([0086] and Fig. 5C: “metering chambers 451A”) as in Claim 2.
Lin does not teach the 2nd chamber having a first opening from a port above the nominal fill line, see the above discussion regarding the same for Claim 1.
Lin does not teach the conditioned chamber as connected directly to at least one port. However, Lin does teach injection chamber 410 for delivering sample or reagent to process chamber 420 (conditioned chamber). As discussed above, the injection chamber 410 must inherently comprise at least one injection port. Given that both the claimed directly connected port as in Claim 2, and the prior art port combined with injection chamber, serve the same purpose of introducing sample or reagent to the process chamber, the device having the claimed relative arrangement of parts would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said port – see MPEP 2144.04 (VI)(C).
Further, one of ordinary skill in the art would find it obvious that if additions to the process chamber (conditioned chamber) are desired to be at varied times or be composed of varying substances, one could simply fill the injection chamber, activate the drive module to transfer the liquid from the injection chamber to the process chamber, then halt the drive module, add another liquid to the injection chamber, and re-activate the drive module to combine the liquids in the process chamber.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin teaches a relief patterned substrate that defines the plurality of microfluidic chambers and channel interconnections (Fig. 2 and [0042]: “The microfluidic platform 20 comprises...a microfluidic element 40 configured between the center of rotation 21 and the circumference 22. In some other embodiments, the microfluidic platform 20 may comprise multiple microfluidic elements 40. The multiple microfluidic elements 40, depending on the requirements, may be fabricated as connecting or independent to each other.” – Given that the microfluidic elements are shown and discussed by Lin as a pattern of channels and chambers, the arrangement is thereby relief patterned given the “relief” of material formed in a pattern to give the overall pattern of channels and chambers.), as in Claim 4.
Regarding the reference axis, center line, and top edge, Applicant has not provided a sufficient substrate structure such that one of ordinary skill in the art would be able to positively and unambiguously ascertain the locations of said reference axis, top edge, and center line. See the 35 USC 112(b) section above. As discussed above, Lin provides a commensurately structured and arranged microfluidic chip, in which the chip of Lin likewise includes a reference axis position according to any one of the choices provided in claim 4 in as much as claimed and required herein with respect to such a position existing within the space of Lin.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Discussion relating to a nominal fill line is indefinite and does not hold patentable weight as discussed above. Further, Lin teaches a conditioned chamber and a 2nd chamber, and said chambers are capable of having an etch depth greater than any of the other chambers, as in Claim 9. Changes in size/proportion of the chamber do not hold patentable weight without evidence of criticality or unexpected results – see MPEP2144(IV)(A).
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin teaches a microfluidic device having a conditioned chamber with a plurality of openings to outlet chambers as discussed above, and support for a microorganism or a cell (the walls of any of the chambers taught by Lin), as in Claim 12.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, applicant does not define a subset of the plurality of ports, and use for pneumatic actuation is merely an intended use which the prior art ports are capable of. Thus, Lin’s teaching of a microfluidic device with ports 480 (Fig. 3B) meets the requirements of Claim 13. Further, the locations of said ports being on an outer edge of the chip hold no patentable significance. The device having the claimed relative arrangement of ports would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said ports – see MPEP 2144.04 (VI)(C).
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, one of ordinary skill in the art would conclude that the chip taught by Lin is covered/enclosed to prevent fluid from leaking out and to permit the functionality of the chip. Further, the chip taught by Lin is a cartridge for mounting to a centrifuge. Note that the centrifuge of the claim is an intended workpiece and its features of a pressurized carrier gas supply and pneumatically accessible port are not required. Further, the ports taught by Lin are pneumatically accessible.
Regarding Claim 21, the prior art meets the limitations of Claim 1 as discussed above, wherein the 1st chamber taught by Lin is axis-proximal, and the 3rd chamber is axis-distal in as much as is defined by Claim 21, given that the reference axis position is not particularly defined..
Regarding Claim 25, the prior art meets the limitations of Claim 1 as discussed above. Further, given that the nominal fill line and reference axis can be anywhere within the device as discussed above, the chip taught by Lin has three or more channels other than the second channel with respective axis-prominent segments, connect the conditioned chamber to respective chambers having shapes and positions, in as much as is discussed by Claim 25.
Regarding Claim 26, the prior art meets the limitations of Claim 1 as discussed above. Given that applicant does not give a reference to which a tilt angle is measured, in as much as is discussed by Claim 26, Lin teaches a chip wherein a range of tilt angles of less than 45 is sufficient to sequentially transfer between the conditioned chamber and the three respective chambers.
Regarding Claim 27, the prior art meets the limitations of Claim 1 as discussed above. Further, while Lin does not teach the first channel comprising a hydrodynamic constriction and a metering chamber, Lin does teach the second channel having a metering chamber and a hydrodynamic constriction. One of ordinary skill in the art would find it obvious to merely provide a second of the hydrodynamic constriction and metering chamber pair if metering of fluid traveling from the injection chamber to the process chamber is desired. Thus, Claim 27 recites nothing more than the predictable use of known elements and lacks evidence of unexpected results associated with providing multiple of said hydrodynamic constriction and metering chamber. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B).
Regarding Claim 28, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin teaches a chip and liquid for loading onto the chip, which are capable of being packaged as a kit ([0044]), as in Claim 28.
Regarding Claim 29, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin teaches a liquid containing a biological sample for the conditioned chamber ([0044]), as in Claim 29.
Regarding Claim 30, the prior art meets the limitations of Claim 1 as discussed above. Further, assembly of the kit and its use with a centrifuge are an intended use and do not hold patentable weight over Lin.
Regarding Claim 31, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin teaches a system comprising the chip, a liquid contained in one of the chambers, where the liquid is a biological sample in the conditioned chamber ([0044]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, as applied to Claims 1-2, 9, 12-13, 18-19, 21, and 25-31 above, in further view of Kornilovicii et al. (US20210322992A1), referred to herein as “Kornilovicii”.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, while Lin teaches the microfluidic device discussed above, Lin does not teach a thermally absorbing and distributing material is provided adjacent one of the conditioned chamber and the 2nd chamber, as in Claim 16.
However, Kornilovicii teaches an analogous microfluidic chip wherein a heating element 150 is thermally coupled to the microfluidic reaction chamber 110 to heat a fluid when present therein ([0038]), for the purpose of catalyzing and/or accelerating chemical reactions ([0010]). Fig. 1A shows the heading element 150 is positioned adjacent to the reaction chamber 110. A heating element must necessarily be a “thermally absorbing and distributing material” to achieve its fundamental role of heating an adjacent structure.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the microfluidic device taught by Lin with the heating element assembly taught by Kornilovicii for the purpose of heating liquid within the chamber to catalyze and/or accelerate a reaction within the chamber involving said liquid.
Regarding Claim 17, the prior art meets the limitations of Claim 16 as discussed above. Further, Lin and Kornilovicii do not specifically teach two separately addressable bands of the material (described in Claim 16) are provided for independently heating the conditioned chamber, and the 2nd chamber, as in Claim 17.
However, given that the claim is drawn solely to the independent heating of two different chambers of the microfluidic device, one of ordinary skill in the art would find it obvious to merely provide a second of the heating element taught by Lin/Kornilovicii. Thus, Claim 17 recites nothing more than the predictable use of known elements and lacks evidence of unexpected results associated with providing multiple of said heating elements. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, as applied to Claims 1-2, 9, 12-13, 18-19, 21, and 25-31 above, in further view of Blaga et al. (US20100303687A1), referred to herein as “Blaga”.
Regarding Claim 22, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin doers not teach a microfluidic device composed of a thermoplastic, thermoplastic elastomer, or PDMS with a suitable gas impermeable layer, as in Claim 22.
However, Blaga teaches a microfluidic structure ([0003]) composed of a material selected from a thermoplastic or a cross-linked plastic ([0007]). Blaga teaches the benefit of said material as “configured to be less sticky than the entire contact surfaces of the fluidic and actuation surfaces which enables selective bonding of the elastomer [the top layer] to controlled areas of the valve.” The elastomer layer is a gas impermeable layer ([0091]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to manufacture the microfluidic device taught by Lin from a choice of the thermoplastic materials taught by Blaga to allow the elastomer layer to bond selectively to areas of the fluidics layer (having channels and chambers).
Regarding Claim 23, the prior art meets the limitations of Claim 1 as discussed above. Further, Lin/Blaga teach a microfluidic chip having a thermoplastic elastomer layer (discussed above for Claim 22) and a covering layer (Blaga part 105). In as much as is discussed by the claim, this covering layer is a pneumatic control layer. Blaga further teaches pneumatic valves within the chip, each valve being either normally open, normally closed, or a state between open and closed. Blaga teaches the benefit of said valves as regulating fluid flow within a fluid conduit ([0010]). Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the thermoplastic microfluidic chip taught by Lin/Blaga to further include the valves taught by Blaga to regulate fluid flow within fluid conduits of the chip.
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Response to Arguments
Claim Objections
Applicant’s amendments sufficiently overcome the claim objection set forth in the previous office action regarding a literal interpretation of “chambers numbered 1, 2, and 3” as physical numerical labels of the chambers, as introduced in Claim 1. As such, the claim objection is withdrawn.
35 USC 112
Regarding Claim 4, and as best understood, Applicant argues that merely reciting a chip is sufficient that one skilled in the art would find it obvious that a structure having a top edge and center line must exist. However, Applicant has also amended the claim in response so as to provide a substrate in which the microfluidic channels and chambers are formed within.
Regarding Applicant’s arguments: Examiner notes that stating “a microfluidic chip” as a generic descriptor in the preamble is not sufficient for one skilled in the art to unambiguously and positively conclude that the channels and chambers are formed within a substrate having defined edges/center line. Under a broadest reasonable interpretation, a microfluidic chip may take the form of a circular wafer, which has only a singular circumferential edge and infinite center lines (if the center line is taken as the center line of the overall circular structure). Further, one may reasonably interpret the device as a series of discretely formed chambers connected by discrete rigid or flexible tubing (no overall etched substrate provided), wherein no specific top edge or center line would be unambiguously understood by one skilled in the art.
Regarding Applicant’s amendments: Applicant’s Claim 4 amendment reciting “a relief patterned substrate that defines the plurality of microfluidic chambers and channel interconnections” is taught by Lin as discussed above in the body of the action, wherein the pattern of channels and chambers of empty volume constitutes a relief pattern of the substrate 20, as discussed by Lin para. [0042].
However, further regarding the Claim 4 recitations drawn to “top edge”, “center line”, and “reference axis”, the claim remains as not specifically defining the positions of the top edge, center line, and reference axis, thereby remaining indefinitely positioned within the device. Additionally, these elements do not appear to Examiner to “devolve from basic geometry from the reference axis position” as Applicant states (page 8, para. 1), given that the tope edge and center line appear to be utilized to denote the position of the reference axis, and not vice versa. Further note that Claim 1 remains as merely reciting “a reference axis position” wherein said position does not appear to be specifically defined by the claim.
See further MPEP 2173.05(b)(II): “A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite.”
Regarding Claim 9, Applicant’s amendment removing phrasing drawn to a surface area of the fill line sufficiently overcomes the 35 USC 112(b) rejection set forth by the previous office action. As such, said rejection of Claim 9 under 35 USC 112(b) is withdrawn.
Regarding Claim 30 antecedent basis, Applicant argues that the centrifugal microfluidic chip controller is no more positively required by Claim 30 than it is in Claim 28 and thereby has antecedent basis through Claim 28. Applicant further requests suggestion to positively claim said controller.
Regarding Applicant’s arguments: This is not persuasive because while Claim 28 requires the chip as being capable of attachment to a centrifugal microfluidic chip controller, Chaim 30 recites actual structural joining of the microfluidic chip and the centrifugal controller, thereby requiring the centrifugal controller to be a positively recited element having specific antecedent basis in the claims.
Regarding Applicant’s request for suggestion: Examiner suggests Applicant simply amend Claim 30 to recite “mounted to a centrifugal microfluidic chip controller”. Further note that Examiner’s previous office actions make no mention of “partial antecedence” as stated by Applicant, wherein the prior office action makes clear the lack of antecedent basis regarding the centrifugal microfluidic chip controller.
Further regarding Claim 30, Applicant argues that the 112(b) rejection regarding Claim 30 failing to choose which of the elements of Claim 28 are included is baseless as the claim includes all the subject matter of the claim on which it depends and qualifies which subject matter is referred to.
This is not persuasive because a claim reciting alternatives is not assumed by one skilled in the art to provide every alternative to claims which depend from it. A claim must specify which alternative is chosen and thereby limited by the dependent claim.
In Claim 28, the claim specifies “the kit is accompanied by the liquid” thereby specifying that the first alternative of Claim 28 “a liquid for loading onto the chip” is chosen.
Conversely, Claim 30 fails to recite on the order of “wherein the kit is accompanied by the one or more cartridge forming elements”. Therein, it is unclear if the kit of Claim 30 requires the liquid, the cartridge forming elements, or both. Examiner suggests Applicant amend the claim on the order of the recitation provided above.
35 USC 103
Applicant’s arguments are on the grounds that:
(page 10) allegedly, while Lin teaches gas flow, Neither Lin nor Duncombe teach gas flow as in the present invention to control gas supply from another chamber of a chip to a conditioned chamber, wherein Lin merely teaches compression of gas within a chamber and not between chambers.
This is not persuasive because the argument regarding gas supply from one chamber of the chip to another chamber of the chip has no basis in the claims, which do not specifically mention gas flow between chambers of the chip. Further, Lin teaches gas flow between chambers of the chip given that decompression of gas in the air chamber causes it to flow through the chip into chambers and be vented by the air vents (See [0010] and Fig. 3B). Applicant further admits that gas is displaced from the chambers, but that it cannot “perfuse anything”. Examiner disagrees; air from these chambers is fully capable of perfusion given that it is understood as ambient, oxygen-containing air.
(page 11) allegedly, regarding Lin, the same channel where milk is metered and delivered to test strips cannot meet the conditioned chamber above and below the fill line of the same conditioned chamber, as in Claim 1.
This is not found persuasive because, as discussed above in the body of the action regarding Claim 1, the fill line is merely a nominal spatial designation not particularly defined within the conditioned chamber. Taking Lin Fig. 3B, for example, if the fill line were drawn across each conditioned chamber longitudinally, the respective second and third channels meet the conditioned chamber both above and below the fill line, despite being aligned with one another.
(page 12) allegedly, the second channel could be said to have no valve nor capillary dimensioned constriction, as in Claim 1.
This is not found persuasive because while the detection chamber 453A of Lin comprises a constriction connecting it to the metering chamber 451A, this constriction is not part of the second channel 440, it is solely a connection between the metering chamber 451A and the detection chamber 453A (as shown in Fig. 5A) and does not involve the second channel 440.
(page 12) Applicant further asserts that “second connection channel 422” (Lin Fig. 3B) acts as a microfluidic valve.
This is not found persuasive because Lin makes no mention of the second connection channel 422 as acting to restrict flow as a valve or equivalent thereof, wherein it further appears from Fig. 3B that the channel has sufficient width to allow fluid to flow freely therethrough.
(page 12) allegedly, the second chamber does not comprise a port opening above its fill line, as in Claim 1.
This is not found persuasive because while the port of Lin (as shown in the annotated Fig. 3B above) is not attached directly to the second chamber, the port remains as a venting point for the second chamber. Further, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one skilled in the art would find it an obvious matter of design choice to provide the port as attached to the second chamber chamber given that the base function of releasing air from the device to be replaced by liquid remains the same, and that Liquid flows into the second chamber from the metering chamber when the centrifuge rotational speed is accelerated.
(page 13) allegedly, there is no third channel connecting the third chamber to the conditioned chamber, as in Claim 1.
This is not found persuasive because regarding Lin, the third channel connects with the conditioned chamber via the second channel as shown through the annotated Fig. 3B above. Applicant may wish to specify on the order of “directly” connecting the third chamber to the conditioned chamber.
(page 13) allegedly, a port in the injection chamber, as in Claim 1, does not necessarily and inherently exist in Lin, the chip could be punctured with a needle or pre-loaded.
This is not found persuasive because Lin discusses sample loading in para. [0074]: “The operating method begins with injecting a first test solution into an injection chamber of a gas-based microfluidic device. After the step of injection, the microfluidic platform starts rotating to drive the first test solution in the injection chamber to flow into a process chamber.” As Lin makes no mention of penetrating a soft substrate with a needle, nor pre-loading a liquid sample and sealing the chip as part of the injection step, as suggested by Applicant, Lin’s recitation requiring injection followed by centrifugation with no particular steps therebetween implies an injection port in the injection chamber.
(page 13) allegedly, the second chamber of Lin has no opening to a channel below a nominal fill line, as in Claim 1.
This is not found persuasive because, as discussed above, the fill line is a mere nominal designation in space not particularly defined by Applicant’s claims. Further, the term “below” is a relative term that one skilled in the art may construe differently depending on the orientation in which the chip is viewed. As such, the opening of the second chamber of Lin is said to be below its nominal fill line, wherein it may also at the same time be said to be above the nominal fill line depending on how the device is oriented.
(page 14) Applicant further argues against 453A in as a spillway as in Claim 2, but admits that this was not recited by any prior office action. Thus, as this argument is not drawn to any actions or recitations made by Examiner on the merits, the argument has no basis. Examiner did not construe the element 450A of Lin as a spillway in any of the previous office actions and did not intend to do so.
(pages 14-15) allegedly, the direct connection of the port to the conditioned chamber is critical for humidification and other gas control, wherein other ports of the device of Lin, including the implied injection port, would not condition the chambers; and Lin teaches against ports anywhere in the device due to spillage.
This is not found persuasive because the ports of Lin connected to the second channel are fully capable of conditioning the conditioned chamber given their fluid/gaseous connection through the second channel. Further, the ports of Lin serving to evacuate gas volume to be replaced by liquid are fully capable of performing that function when filling the conditioned chamber if connected directly to the conditioned chamber, given gas is evacuated from the conditioned chamber when liquid is added. Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C).
Further, Lin’s discussion of spillage does not refer to spillage from the chip, but rather intended spillage of the test solution to the overflow channel (see Lin para. [0060], for example).
(page 16) allegedly, one would not be motivated to add liquids to the chip of Lin at varying times because stopping centrifugation would disrupt any achieved layering.
This is not found persuasive because layering within the detection chamber is not a necessitated, inherent, or taught effect in Lin, wherein one may add a first liquid to undergo a first reaction, such as supramolecular binding” then stop centrifugation and introduce a second liquid to detect such binding. This example is non-limiting, wherein one skilled in the art may find numerous reasons for introducing fluid to the chip at different times for achieving different chemical effects. Applicant further argues that this would defeat the purpose of Lin as the sediments discussed in para. [0085] would be released; however, this is not persuasive because sediments are held in the storage chamber 460.
(page 16) allegedly, one skilled in the art would not find it obvious to add liquids at different times to the chip because centrifuges are not good mixers.
This is not found persuasive because the force of fluid entering each chamber as controlled by the speed of the centrifuge would result in sufficient mixing, and simple diffusion provides additional mixing. Merely stating that centrifuges are not good at mixing is not sufficient to preclude one of ordinary skill in the art from introducing various liquids to the chip. Further, samples introduced to the chip need not be mixed at all. For example, an organic washing solution may be provided after introducing an aqueous solution so as to extract unwanted organic components from the aqueous layer, a process that does not require mixing.
(page 17) Applicant re-states arguments drawn to the injection port of the chip, as in Claim 1, and airflow between chambers. See the above discussions regarding these assertions.
Applicant further describes a concern drawn to claim 1 and amended the claim to recite “meeting” instead of “connecting”. As this was not an issue recited by any of the previous office actions, no further discussion appears to be necessary.
(page 18) allegedly, the relative channel and chamber etch depths, as in Claim 9, are critical given the instant specification para. [0018] discussion requiring larger chamber sizes for larger volumes of gas to be delivered.
This is not found persuasive because para. [0018] does not specifically mention etch depth, wherein larger chambers for accommodating larger volumes of gas as discussed by para. [0018] may be achieved with channels having the same etch depth but differing length/width. While this opposes the paragraph’s notion of “spatial constraints” on a microfluidic chip, the depth remains non-critical given it is easily circumvented by modifying the other dimensions of the chambers.
(page 19) Regarding Applicant’s additional remarks:
While Examiner agrees that comparing openings to a nominal fill line is meaningful, the location of the fill line is not sufficiently defined by the instant claims such that one skilled in the art could unambiguously determine its location.
Even if some cells can grow on a flat plastic surface, said surface constitutes a support for a cell. Further, the claims do not require the cells to grow on the surface, but merely be supported by the surface, which it is capable of doing for all cells.
While the previous office action establishes chamber 460 as having an outlet from the conditioned chamber, chamber 460 is not singularly relied upon for providing a plurality of openings. The conditioned chamber’s plurality openings open to 460, 430, 410, and 440.
Alignment of the ports is not what the previous office action construed as intended use, but rather the ports’ use for pneumatic actuation. Regarding the alignment, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Therein, the ports of Lin maintain their function of passing gas therethrough regardless of being aligned or not.
While Applicant is correct in their ability to define a subset of ports from a group of ports, Applicant is required to specify which of the ports comprise the subset of ports. One of ordinary skill in the art would not find it obvious which ports of the device comprise the “a subset of ports” without a sufficiently defined subset pointing to the specific ports intended to be included in the subset of ports. Examiner notes that this language is not rejected as indefinite, but merely is broad such that any selection of the ports satisfies a subset of the ports.
The centrifuge is an intended workpiece because it is worked on by a tool/machine (the microfluidic chip) given Applicant’s stated definition “an object being worked on with a tool or machine”. The phrase “to be worked on” does not necessitate manufacturing.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798