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 .
Remarks
This office action fully acknowledges Applicant’s amendments and remarks filed 20 January 2026. 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No claims are withdrawn.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 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 1-2, 4, 9, 12-13, 16-18, 21-23, and 25-30 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.
Claims 1-2 and 4 are amended to recite “axis-proximal” and “axis-distal” wherein these terms are unclearly defined as the terms are not standard terms of art and the instant disclosure fails to provide particular meaning to the terms. Where applicant acts as his or her own lexicographer to specifically define a term of a claim, the written description must clearly define the claim term and set forth the definition so as to put one reasonably skilled in the art on notice that the applicant intended to so define that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The terms are indefinite because the specification does not clearly define the terms. Further, the terms “axis-proximal” and “axis-distal” are predicated by the claims on the nominal fill line, which is another non-structural, imaginary spatial designator of the claim. By this, it remains unclear the particular position(s) of the reference axis position and structures thereto designated as “axis-proximal” or “axis-distal” as the claim presently depends these limitations from an arbitrary line position not definitely oriented by the claim to a particular position of the device.
The terms “proximal” and “distal” with respect to the “axis” in Claims 1-2 and 4 are relative terms which render the claim indefinite. The terms “proximal” and “distal” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “proximal” is defined as “situated nearer” and the term “distal” is defined as “situated further” wherein both the degree of nearness/farness is indefinite, and wherein the actual spatial designation is unclear with respect to the axis given that the claims do not make a comparison between structures (one structure more proximal to another structure which is more distal), but rather describe discrete structures as axis-proximal and axis-distal such that one skilled in the art would not be able to determine the location of the referred to structure given that at present all that is recited is, in effect, a structure “close to the axis” and a structure “far from the axis”, which could further be interpreted in different ways depending on which point of the axis the measurement is taken from. This is further seen as indefinitely defined in the
“-proximal” and “-distal” disposition as both are predicated on a nominal fill line that implicitly has no particular, defined place.
Appropriate clarification is required.
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.
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 axis-proximal 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 axis-distal 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 axis-proximal its nominal fill line, and no opening to any interconnecting channel or port axis-distal 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, axis-proximal 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 axis-distal 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.).);
whereby the conditioned chamber is adapted to: receive liquid supply from the 1st chamber (the conditioned chamber is directly connected to the first chamber and receives liquid from the first chamber (previously injected into the first chamber by an operator) when the centrifuge is initiated); receive gas supply from the 2ⁿᵈ chamber (as the conditioned chamber is in fluid communication with the 2nd chamber), vent excess gas through its port (as all the ports of Lin are configured to vent excess gas or are ports to other chambers which can accommodate vented gas/compressed gas), and send waste liquid to the 3rd chamber (by way of the fluid connection between the conditioned chamber and the waste chamber through the second channel),
as in Claim 1.
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, and a nominal fill line defined with respect to a reference axis position; 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 1st and 2nd chambers, where:
The 1st chamber has a first opening from a port axis-proximal 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 axis-proximal the conditioned chamber's nominal fill line;
The 2nd chamber having a second opening to a second channel axis-proximal the nominal fill line, and no opening to any channel axis-distal 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; whereby the conditioned chamber is adapted to: receive liquid supply from the 1st chamber (the conditioned chamber is directly connected to the first chamber and receives liquid from the first chamber (previously injected into the first chamber by an operator) when the centrifuge is initiated); receive gas supply from the 2ⁿᵈ chamber (as the conditioned chamber is in fluid communication with the 2nd chamber), vent excess gas through its port (as all the ports of Lin are configured to vent excess gas or are ports to other chambers which can accommodate vented gas/compressed gas), and send waste liquid to the 3rd chamber (by way of the fluid connection between the conditioned chamber and the waste chamber through the second channel), 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.
Further as in Claim 2, Lin does not teach the 2nd chamber having a first opening from a port axis-proximal the nominal fill line, see the above discussion regarding the same for Claim 1.
Further as in Claim 2, 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 the centrifugal microfluidic chip having a length L and a width W (The length and width of the chip seen through Fig. 2.), and comprises a relief patterned substrate that defines the plurality of microfluidic chambers and channel interconnections arrayed with respect to the reference axis position (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.),
wherein the reference axis position:
lies within a first rectangular region that excludes the chambers and extends beyond the chip on one side of the chip a length of 3/2 L (As all that is claimed is an arbitrary rectangular region of any size/length able to be placed anywhere in the chip effectively excluding any of the chambers, the reference axis position remains as being able to be recognized by one skilled in the art at any position of the chip under its broadest reasonable interpretation.),
the first region having a width equal to L that is centered on the chip’s width (The arbitrary region in Lin is fully capable of being equal to the chip’s length (any arbitrary length dimension of the chip) and be centered on the chip’s width (any arbitrary width dimension of the chip)), lies within a second rectangular region that excludes the chambers and extends beyond the chip on one side of the chip a length of L (Similarly as above, as all that is claimed is an arbitrary rectangular region of any size/length able to be placed anywhere in the chip effectively excluding any of the chambers, the reference axis position remains as being able to be recognized by one skilled in the art at any position of the chip under its broadest reasonable interpretation.),
the first region having a width equal to W that is centered on the chip’s width (The arbitrary region in Lin is fully capable of being equal to the chip’s width (any arbitrary width dimension of the chip) and be centered on the chip’s width (any arbitrary width dimension of the chip)),
lies between two lines passing through a midpoint of the two openings of the 2ⁿᵈ chamber, the two lines being bisected by a perpendicular bisector of the two openings, and respectively making an angle of 30° and -30° with the perpendicular bisector; or is separated from P1 and from the opening to the second channel, and these separations are different by no more than a factor of 2, and the nominal fill line of the 2ⁿᵈ chamber includes a volume of at least 33% of a volume of the 2ⁿᵈ chamber axis-distal the nominal fill line (Similarly as above regarding the imaginary reference axis position, the “two lines passing through a midpoint of the two openings of the 2ⁿᵈ chamber” are mere spatial reference markers having no particular structural basis in the claims. Herein, the channels and chambers of Lin are provided as satisfying this limitation regarding the two lines as the nominal fill line itself is further drawn to a mere spatial designator. Thus, in effect, two arbitrary designators are provided in reference to one another, the breadth of which reading on the device of Lin. Further, even if the arrangement of Lin were to not satisfy the limitations above, 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, the channels and chambers of Lin and the instant claims commensurately serve the identical functions of fluid and gas actuation and their position is thus seen as an obvious matter of design choice absent a showing of criticality or unexpected results.),
as in Claim 4.
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]); the chip further has a material for application to a cartridge and providing thermal control over the conditioned chamber (the bottom laminate layer through which heat would travel to the conditioned chamber) 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. Further, the chip of Lin is mounted to a centrifugal microfluidic chip controller ([0037-0038]).
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 resolve the inconsistent chamber labeling objected to in the previous office action (1st, 2nd, and 3rd chambers as well as chambers numbered 1, 2, and 3).
As such, the objection to Claim 2 is withdrawn.
35 USC 112
Applicant argues that Claim 4 has been amended to remove “top edge,” “center line,” and “above the chambers,” and that the amended length/width/region language excludes a circular disk and provides sufficient clarity.
As Claim 4 no longer relies on the previously objected-to relative terms “top edge,” “center line,” and “above the chambers,” the prior basis of indefiniteness is moot. As such, the indefiniteness rejection over Claim 4 is withdrawn.
Further, Applicant’s amendments sufficiently overcome the indefiniteness of the disc-based center line, top line, etc...; however, the claims remain as reading on a disc shaped microfluidic chip as in the primary prior art reference of Lin under the broadest reasonable interpretations and in view of the newly recited “rectangular regions” of the chip – see below.
Applicant’s assertion that a disc cannot have a length and a width is not persuasive for the instant claims to exclude a disc-shaped chip. A disc has a length and a width; and further, Applicant’s “reference axis position” (and axis-proximal/distal), “nominal fill line”, and “rectangular regions” remain as fully applicable to a disc as each of these limitations are non-structural in nature and drawn to mere reference points with many possible interpretations.
Applicant argues that Claim 30 should not require positive recitation of the centrifugal microfluidic chip controller for antecedent basis, but states that the claim has been amended to follow the Examiner’s suggested wording.
As Claim 30 now positively recites the centrifugal microfluidic chip controller, the antecedent basis rejection is withdrawn. However, Applicant’s argument that any mere “mention” in a parent claim automatically provides sufficient antecedent basis is not correct. Where a parent claim recites an element only as part of intended use/capability language, a dependent claim that later requires actual structural joining to that element must clearly positively require the element being joined. The claim must make clear what structure(s) is/are actually included in the claimed combination.
Claim 4 remains to recite the limitation "P1". Claim 1 is amended to recite “a port (P1)”, providing the necessary antecedent basis in Claim 4. Thus, the rejection of Claim 4 for lacking antecedent basis for P1 is withdrawn.
35 USC 103
Claim 1 & dependents
Applicant argues on the alleged grounds that the present amendment adds a “whereby” clause specifying the purposes of the numbered chambers, including liquid supply, withdrawal, and gas supply/perfusion.
Applicant’s arguments are not persuasive because the newly added “whereby” clause regarding the conditioned chamber is a statement of intended purpose and does not patentably distinguish the claimed apparatus as it does not impose any further a structural limitation on the claimed device. The prior art need not disclose Applicant’s preferred purpose using Applicant’s terminology if the prior art structure is capable of performing the recited function or otherwise meets the structural limitations of the claim.
To the extent the amended language is merely directed to the result or intended use of chambers that are structurally met by Lin, the amendment does not distinguish over Lin. The rejection remains based on the actual chamber/channel/port structure of Lin and the ordinary capabilities of such structures when fluid and gas are displaced through a centrifugal microfluidic chip – see below.
Further, the conditioned chamber of Lin is commensurately “adapted to” receive liquid supply from the 1st chamber (the conditioned chamber is directly connected to the first chamber and receives liquid from the first chamber (previously injected into the first chamber by an operator) when the centrifuge is initiated); receive gas supply from the 2ⁿᵈ chamber (as the conditioned chamber is in fluid communication with the 2nd chamber), vent excess gas through its port (as all the ports of Lin are configured to vent excess gas), and send waste liquid to the 3rd chamber (by way of the fluid connection between the conditioned chamber and the waste chamber through the second channel), as in the “whereby” clause added to the amended Claim 1.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that neither Lin nor Duncombe teaches a conditioned chamber adapted for liquid supply/withdrawal and controlled flowing of gas through the conditioned chamber from the second chamber so as to facilitate gas perfusion.
Applicant’s argument is not persuasive because Applicant’s argument imports a more specific cell-culture perfusion system into the claim than is actually recited. The claim does not require a dedicated humidifier or humidification system as structural components, nor does the claim positively require any liquid to be within the device as part of the actual claim construction, not mere intended use with a liquid sample as presently recited. The claim merely requires that the condition chamber be “adapted” to receive gas from the second chamber. As the conditioned chamber is in fluid communication with the second chamber, the conditioned chamber is thereby commensurately structured to receive a gas from the second chamber in as much as is claimed.
The claims recite structural relationships among chambers, channels, ports, reference axis position, and fill lines. Lin teaches a centrifugal microfluidic chip having chambers, channels, ports, gas compression/decompression, vents, and liquid movement among chambers. Gas displacement through the chip occurs as liquid is moved and gas is vented. Such gas is fully capable of interacting with liquid and chamber headspace among the conditioned chamber and the second chamber during operation. Thus, Lin is fully capable of satisfying the amended recitations discussed above.
Applicant’s argument that Lin lacks an express need for humidification, perfusion, or a stream of gas does not sufficiently render the rejection non-obvious. The prior art need not recognize the same problem as Applicant where the claimed structure would have been obvious, and the claimed functional flows within the structure or would have been expected by one of ordinary skill in the art given the above discussed fluid communication between the channels and chambers of the device.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that Lin cannot supply the conditioned chamber with vapor released from the second gas-supply chamber and that Lin has no need for humidification or subjecting a chamber to a stream of gas.
Applicant’s arguments are not persuasive because the claims are not limited to vapor released by evaporation from a particular gas-supply chamber (the second chamber), nor are they limited to humidification (no liquid or vapor is present in the elements positively required by the claim, no humidifier or humidification system is claimed). Applicant’s repeated characterization of the claimed invention as requiring a specific gas-perfusion or humidification regime is not commensurate with the claim language. Lin’s gas-containing chambers, vents, and channels provide gas flow paths and gas displacement as liquid is moved. A chamber connected to such gas flow is capable of being conditioned by the gas, at least by displacement, diffusion, headspace exchange, or exposure of liquid to gas.
Further, even if Lin does not expressly discuss humidification, one of ordinary skill in the art would have recognized that gas in a microfluidic chamber can condition a liquid or chamber environment where the gas is supplied, displaced, or exposed to a liquid interface.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that the “nominal fill line” cannot be placed anywhere, that fill lines are properties of chambers, and that one coherent fill line must be assigned for each chamber relative to a single reference axis.
Applicant’s arguments are not persuasive because the broadest reasonable interpretation of “nominal fill line” is applied in view of the instant disclosure: The claims do not recite a particular fill volume, centrifugation rate, rotational protocol, meniscus shape, or exact geometric construction for the nominal fill line. Thus, the term remains broad and encompasses any reasonable nominal spatial designation of a fill level for the chamber relative to the reference axis. Further, the “fill” portion of “fill line” remains nominal in nature whereas all that is claimed is, in effect, an imaginary line not necessarily corresponding to what appears to be Applicant’s intent as it being the meniscus of fluid within a chamber.
Applicant’s own wording designates the fill line as a “nominal” fill line, i.e. being in name only. The fill line is not a particular structural component of the claimed device and insufficient detail has been provided such that one of ordinary skill in the art would recognize this nominal fill line as being in a particular position for each of the chambers.
Applicant’s argument that one skilled in the art could select a reasonable fill line confirms breadth, not patentability. Where the claim does not require a specific fill line, the prior art need only meet the limitation under a reasonable interpretation of the fill line as an abstract, imaginary, non-structural spatial designator of the device not presently sufficiently restricted to a single unambiguous position as discussed above.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that Lin lacks a channel coupling chamber 420 to chamber 470 below chamber 420’s fill line, and that the Office cannot choose inconsistent fill lines.
Applicant’s arguments are not persuasive because, as set forth in the prior rejection, the nominal fill line is not defined in the claims with the level of particularity Applicant presently argues. The rejection reasonably interprets the channel/chamber arrangement of Lin in view of the claimed breadth of relative spatial relationships as consistent with that of the instant claims. Applicant’s argument depends on selecting a preferred fill line and then requiring all prior art structures to be judged against that selection; however, as discussed above, the fill line is a selection up to an observer of the device wherein many fill lines may be present depending on the orientation of and/or amount of liquid in the device.
Further, Lin’s channels and chambers are arranged radially on a centrifugal platform, and liquid/gas movement is governed by rotation, pressure, and venting. Under the broadest reasonable interpretation, the claimed above/below—or amended axis-proximal/axis-distal—relationships are met by Lin’s radially arranged chambers and connecting channels. To the extent Applicant now requires a precise fill-line arc and specific connection below that arc, such requirements must be expressly recited in the claim.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that the third chamber port in Lin is not inherently present because liquid may be loaded by syringe puncture, resealing membrane, or pre-loading before assembly.
Applicant’s arguments are not persuasive because Lin expressly describes injecting a first test solution into an injection chamber and then rotating the microfluidic platform to drive the first test solution into a process chamber. 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. Lin does not describe puncturing a substrate with a needle, using a resealing membrane, pre-loading the chip before assembly, or sealing after pre-loading as part of this operation. Under the disclosure of Lin, the ordinary and reasonable understanding is that an injection opening or port is present to permit injection into the injection chamber.
Applicant’s hypothetical alternatives are not sufficient to defeat inherency or obviousness. The question is not whether one could imagine other undisclosed loading methods, but what Lin reasonably teaches or implies to one of ordinary skill. Given Lin’s disclosed injection step and the absence of any teaching of piercing, pre-loading, or sealing, an injection port/opening is necessarily present or at minimum would have been an obvious design choice for introducing the sample.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that the second chamber of Lin, identified as 450, lacks a second opening to a second channel at or above its nominal fill line and no opening below its nominal fill line.
Applicant’s argument is not persuasive because Applicant’s argument relies on a narrow interpretation of chamber 450 and its surrounding structure that is not required by the claim as the above and below, as well as the nominal fill line, are relative terms which are interpreted broadly in view of Lin as satisfying the second chamber requirements of the claims. Lin shows fluidic communication between the relevant chamber, metering structure, channel, and port/venting arrangement. The claim does not require the opening to be formed in any particular wall segment or by any particular manufacturing feature. Under the broadest reasonable interpretation, the chamber opening is met by the communication path by which fluid/gas enters or exits the second chamber. Further, to the extent the precise placement of an opening relative to a nominal fill line is argued as different, Applicant has not shown criticality or unexpected results associated with such fill line placement. A mere change in position or orientation of an opening, while maintaining the same function of permitting fluid/gas communication, is an obvious design choice; and wherein this point is further supported by the fill line being a spatial designator and not an actual structural component of the device.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that the difference in the placement of the second port with respect to the second chamber and second opening is not mere relocation of a port because Lin allegedly lacks the claimed second opening altogether.
Applicant’s arguments are not persuasive because Lin’s chamber is not considered in isolation from the channels and ports with which it is in fluid communication. The claimed “opening” is a structural communication between the chamber and another fluidic element. Lin’s chamber/channel arrangement provides such communication from the second chamber to the second port. Applicant’s argument treats the claimed opening as requiring a discrete, separately labeled aperture directly attached to a specific chamber wall, but the claims do not require this specific configuration.
Further, even assuming that Lin does not expressly disclose the exact opening location, providing an opening between a chamber and a channel/port to permit venting or liquid transfer would have been an obvious and predictable design choice in a microfluidic device. The function remains the same: permitting passage of fluid or gas evacuation as fluid flows through the device, so as not to be impeded by backed up gas.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that there is no way to provide a port for venting 450 below 440 without leakage or making chamber 3 useless.
Applicant’s arguments are not persuasive because Applicant argues against a specific embodiment not required by the rejection. Obviousness does not require physically inserting a port into Lin exactly as Applicant imagines while preserving every unrelated feature unchanged. The rejection relies on what the prior art teaches and what one of ordinary skill would have found obvious based on predictable design modifications, which, as the recited ports of Lin do not leak, one skilled in the art would find it obvious to provide additional ports as ones which only permit gas flow and/or place the ports in positions where leakage would not occur. Applicant’s speculation that a particular hypothetical port could potentially leak does not establish nonobviousness. Microfluidic chips routinely use ports, vents, channel dimensions, valves, capillary barriers, and pressure control to manage liquid and gas movement. The mere possibility that an improperly designed vent may leak does not mean that providing a vent/opening in a useful location would have been beyond ordinary skill.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that the third channel cannot be provided in part by the second channel, and that the Office has improperly allowed overlap between distinctly named channels.
Applicant’s argument is not persuasive because the claims do not require the first, second, and third channels to be entirely physically separate along their entire lengths unless expressly recited. Under the broadest reasonable interpretation, a channel can include a path segment, and different claimed channels may share or overlap portions where the claim language does not prohibit such overlap. Applicant’s use of different names for channels does not, by itself, require mutually exclusive physical conduits. If Applicant intends the third channel to be a physically separate, non-overlapping conduit extending directly from the third chamber to the conditioned chamber without using any portion of another channel, the claim must recite such a limitation. Absent such language, Lin’s channel path that connects the third chamber to the conditioned chamber, including via another channel segment, satisfies the requirements of the claim in as much as is claimed.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that the Office failed to address amended wording that the third channel “extends” from the third chamber to the conditioned chamber.
Applicant’s arguments are not persuasive because the prior rejection addresses the substance of the connection between the third chamber and the conditioned chamber. The word “extends” does not require direct, uninterrupted, or non-overlapping extension unless the claim specifically states so. A channel path can extend between two chambers through one or more segments. Lin’s structure provides such a path. To the extent Applicant seeks “directly extending” or “without intervening channel portions,” those limitations are not presently required by the claim.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues that “below” and “above” have been replaced with “axis-distal” and “axis-proximal,” and therefore the prior relative-term issue is resolved.
Applicant’s amendment is acknowledged. However, replacing “above” and “below” with “axis-proximal” and “axis-distal” does not overcome the prior art where Lin is expressly a centrifugal microfluidic device arranged about an axis of rotation. Lin’s chambers, channels, and ports have relative axis-proximal and axis-distal positions given that the “reference axis position” is a mere spatially designating imaginary marker which is not particularly restricted to a single location by the claims. One of ordinary skill in the art would identify a reference axis at any position within the device of Lin as such an axis is again a mere imaginary line of the device for relatively orienting the channels and chambers of the device. The amended terminology remains as providing Lin’s radial arrangement.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that direct connection of the port to the conditioned chamber is critical for humidification/gas control and that Lin’s other ports would not condition the chambers.
Applicant’s argument is not persuasive because the claims do not require the asserted level of humidification or controlled perfusion. The ports of Lin are in fluid/gaseous communication with the chip’s chambers and channels and are capable of venting, supplying, or displacing gas. A port need not be directly attached to a particular chamber wall to allow gas exchange or conditioning through an intervening channel.
Further, Applicant’s assertion of criticality is unsupported by evidence commensurate in scope with the claims. The claim does not recite a particular humidity level, gas residence time, flow rate, cell-culture viability result, or perfusion metric. Absent such limitations or evidence of unexpected results, relocating or directly connecting a port to improve gas communication is an obvious matter of design choice.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that Lin allows only diffusive conditioning, not a coordinated gas stream performed for perfusion.
Applicant’s arguments are not persuasive because the claims are not limited to a “coordinated gas stream” or to any particular perfusion regime as asserted by Applicant. Diffusive conditioning, headspace exchange, or gas exposure through fluidic communication is sufficient under the broad claim language merely, in as much as is claimed, requiring gaseous (fluid) communication among the channels and chambers. Applicant’s argument improperly narrows the claim to a preferred mode of gas perfusion not recited.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that a liquid plug pushing a gas plug toward a vent is not perfusion because the liquid and gas translate together and do not move relative to each other.
Applicant’s arguments are not persuasive because the claim does not require a particular gas-liquid relative velocity or continuous gas stream across a free surface. The claim language is structural and is met by the chamber/channel/port arrangement with fluid communication of Lin. Moreover, gas displacement, venting, and exposure of gas to chamber headspace and liquid interfaces are mechanisms by which gas may condition the chamber or liquid. Applicant’s argument again imports unclaimed performance requirements. Applicant may wish to claim the actual gas supply (tank and gas line, for example) and its connection to the microfluidic device. However, this would be open to new search and potential modification under 35 USC 103 for perfusing the fluid in the device of Lin.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that Lin teaches against moving ports because of spillage.
Applicant’s arguments are not persuasive because Lin’s discussion of spillage concerns liquid overflow within the intended operation of the chip (overflow between channels and chambers enabling time-delayed flow operations), not a teaching away from all ports, vents, or port relocation in the device. A reference teaches away only when it criticizes, discredits, or otherwise discourages the claimed solution. Lin does not discourage providing ports/vents in microfluidic chips; rather, Lin uses ports and vents to perform its operation. Applicant’s assertion that a poorly placed port might cause leakage does not amount to a teaching away.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Applicant argues on the alleged grounds that adding liquids at varying times to Lin is not motivated because centrifuges are not good mixers and Lin has no waste path for wash buffer or multistep protocols.
Applicant’s arguments are not persuasive because the rejection does not require Lin to be optimized as a washing or multistep cell-culture system. One of ordinary skill would have understood that liquids may be added at different times to carry out sequential reactions, dilutions, detection steps, rinsing, or other chemical/biological processes. Mixing can occur through centrifugal acceleration, flow-induced mixing, diffusion, chamber geometry, or repeated fluid transfer. Applicant’s assertion that a different chip might be preferable for some protocols does not establish that the recited mode of operation of Lin would have been nonobvious. Sequential addition of liquids in microfluidic devices is a predictable use of known elements.
Thus, in view of the above, the rejection over Claim 1 is maintained.
Claim 2
Applicant argues on the alleged grounds that Claim 2 now recites axis-proximal/axis-distal language and positively recites a nominal fill line defined with respect to a reference axis position, thus overcoming Lin.
Applicant’s argument is not persuasive because Lin is a centrifugal microfluidic chip arranged about a reference axis (radial axis) commensurately as claimed. Merely replacing “above/below” with “axis-proximal/axis-distal” does not distinguish Lin. The chambers and channels of Lin implicitly possess positions that are axis-proximal and axis-distal relative to the radial axis given that the radial/reference axis is a mere spatial designator having no particular structural basis in the claims and which would be recognized by one skilled in the art as potentially existing at a variety of positions.
Thus, in view of the above, the rejection over Claim 2 is maintained.
Applicant argues on the alleged grounds that Lin fails to teach a second chamber with a spillway opening delimiting a nominal fill line.
Applicant’s argument is not persuasive because Lin teaches metering chambers and overflow arrangements for controlling liquid volume (Figs. 5A-C). Where excess liquid flows further along an overflow channel to a waste chamber, the structure functions as a spillway/overflow arrangement defining a nominal liquid level or volume for the associated second chamber. Applicant’s argument that the word “spillway” is not labeled in Lin is not compelling. The prior art need not use Applicant’s terminology if it discloses the corresponding structure and function. Further, as the fill line of a chamber is merely an imaginary spatial designator, the spillway and chamber implicitly have a fill line as an arbitrary designation of how full they may be meant to be filled.
Thus, in view of the above, the rejection over Claim 2 is maintained.
Applicant argues on the alleged grounds that overflow channel 440 is for chamber 420 and not for chamber 450, and therefore cannot delimit a fill line for the second chamber.
Applicant’s argument is not persuasive because the rejection relies on the overall fluidic communication and metering/overflow arrangement shown in Lin. The chambers, metering structures, and overflow channel are not isolated components; but rather elements which cooperate to control liquid distribution. To the extent the claim broadly recites a spillway opening delimiting a nominal fill line, Lin’s overflow/metering structure satisfies that limitation. Further, Applicant’s argument relies on a narrow construction of “spillway opening” requiring a particular labeled overflow channel dedicated solely to the second chamber. The claim does not require such a dedicated structure unless expressly recited. The fill line is a mere spatial designator not having structural basis in the claims and thus may exist anywhere within the device as recognized by one skilled in the art as an imaginary line to which the chamber may be filled and changes depending on the fill and orientation of the device.
Thus, in view of the above, the rejection over Claim 2 is maintained.
Applicant argues on the alleged grounds that no fair interpretation of Figs. 5A-5C provides any overflow or spillway for the second chamber.
Applicant’s argument is not persuasive because Lin describes the metering chambers being filled and excess fluid flowing further along the overflow/second channel, as discussed in the body of the action. The purpose of such an overflow arrangement is to control liquid volume and define a level/volume boundary when the centrifuge increases speed and deposits the liquid from each spillway into eash second chamber. One skilled in the art would understand this as a spillway or overflow function. Applicant’s disagreement with the specific label applied to the structure does not negate the disclosed function.
Thus, in view of the above, the rejection over Claim 2 is maintained.
Claim 9
Applicant argues on the alleged grounds that relative chamber/channel etch depths are critical because increased depth provides higher surface area for effective perfusion, and cites the specification’s discussion of increased surface area and gas diffusion.
Applicant’s argument is not persuasive because the cited portions of Applicant’s specification may describe benefits of increased surface area, but they do not establish criticality of the claimed etch-depth relationship over the prior art. A statement that a feature is beneficial or preferred is not evidence of unexpected results or criticality. It remains well known that increasing chamber size, depth, width, or surface area can increase liquid/gas interface area or chamber volume. As such, such dimensional optimization is a predictable adaptation of a chamber for holding liquid.
Applicant’s own explanation confirms that chamber depth affects surface area and gas-liquid interaction, thus providing for a result-effective variable. Where a variable is known to affect a desired result, optimizing that variable is ordinarily obvious absent evidence of unexpected results. The claims do not recite a specific critical depth, ratio, performance threshold, or unexpected range. Thus, changing the etch depth of chambers relative to channels is an obvious matter of routine design optimization.
Thus, in view of the above, the rejection over Claim 9 is maintained.
Applicant argues on the alleged grounds that paragraph [0016] of the instant specification fully motivates increased etch depth and that the Office was wrong to state that no benefit was indicated.
Applicant’s arguments are not persuasive because Applicant’s specification describing the predictable benefit of increasing surface area supports, rather than defeats, the conclusion that etch depth is a result-effective variable. Without evidence of unexpected results or a critical claimed range, the dimensional limitation does not patentably distinguish over Lin.
Thus, in view of the above, the rejection over Claim 9 is maintained.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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