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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/01/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s amendments and remarks filed 01 September 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No claims are withdrawn.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.
Claims 1-2, 4, and 12 are amended.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 9, 12-13, 16-18, 21-23, and 25-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “[the second channel] is entirely physically separate from the second channel”, wherein the phrase “entirely physically separate” is not disclosed or suggested by Applicant’s specification, and it is unclear what the plain meaning of the phrase refers to. Given the recitation is unsupported, it is treated as new matter herein and should be cancelled in the next amended claims.
*See below under 35 USC 112 B/2nd as well in which it appears that Applicant intends to recite “…physically separate from the third channel.”
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 axis 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 1 recites “[the second channel] is entirely physically separate from the second channel”, wherein it is unclear how a channel can be “entirely physically separate” from itself.
To this end, it appears that Applicant intends to recite “…physically separate from the third channel.” 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 by a centrifugal field that radiates from an axis of rotation of the chip during centrifugation (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 “centrifugal field” precluded from the arrangement provided in Lin, wherein Lin provides a centrifugal force field across the entirety of its contents and structures.);
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 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.); and
is entirely physically separate from the second channel (The separate portions forming the two distinct channels are separated by the off-shooting detection chamber and venting channel arrangements which physically separate the channels walls from one another.); and
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).
Applicant’s recitation “for liquid alimentation of, liquid waste removal from, and controlled gas supply to, a conditioned chamber” is drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the commensurately structured channel/chamber arrangement is fully capable of alimentation of, liquid waste removal from, and controlled gas supply to, a conditioned chamber.
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 by a centrifugal field that radiates from an axis of rotation of the chip during centrifugation; 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 an axis 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.
Applicant’s recitation “for allowing liquid alimentation, liquid waste removal, and controlled gas supply in a conditioned chamber thereof” is drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the commensurately structured channel/chamber arrangement is fully capable of alimentation of, liquid waste removal from, and controlled gas supply to, a conditioned 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 axis (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 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 axis 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 axis 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 axis, 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 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 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
35 USC 112(b)
Applicant’s argument is on the alleged grounds that the terms “nearer” and “farther” are familiar directional concepts in centrifugal microfluidics, even if the exact words are uncommon in academic papers.
Applicant’s argument is not persuasive because rejection does not depend on whether a skilled artisan understands “nearer” and “farther” (proximal/distal); it concerns whether the claim supplies a sufficiently determinate “axis” position against which the recited openings can be compared. Relative terminology is permissible, but its use must leave the claim boundary understandable in light of the specification. — See MPEP § 2173.05(b). Herein, the chamber having an “axis” is provided as an arbitrary axis not particularly required to be in any specific orientation and thus elements which are “nearer” or “farther” from the axis position is indefinitely understood as an infinite number of orientations would be allowed without a particular axis restrained to a particular position. By this, the boundary of the claim is not readily ascertainable and isa thereby indefinite.
Applicant’s further argument is on the alleged grounds that each disputed opening is compared with its chamber’s nominal fill line, so the Office is wrong to say that no comparison is recited.
Applicant’s argument is not persuasive because, while Examiner acknowledges that grammatical comparison, the rejection concerns the location of the nominal line, which the claim does not fix merely by naming it and comparing other structures respective thereto. Applicant’s position that a person may select a reasonable line that makes the recited relationships hold leaves unresolved which fill lines satisfy those relationships, the fill line being indeterminate in the device as presently claimed.
Applicant’s argument is further on the alleged grounds that a fill line is a structural feature of an unloaded chip because its liquid surface can be predicted when the chip is used.
Applicant’s argument is not persuasive because the position of a predicted liquid surface depends on the liquid volume being present in the device and operating conditions of the device, wherein the instant claim is merely drawn to a device ("Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).); calling that position a feature of the chip does not itself establish where it, the fill line, lies for purposes of comparing the chip’s fixed openings. The issue is uncertainty in the resulting boundary of the claim being indefinite, not whether a visible mark must be present on the chip. — See MPEP §§ 2173.04 and 2173.05(b). Applicant’s fill line may differ based on the amount of liquid present in the chip, and the operating conditions under which the chip is subjected, thereby further leaving the positions of elements referenced to such fill lines, which themselves are merely nominal by Applicant’s own wording and are not any physical structure of the device.
Applicant’s argument is on the alleged grounds that defining the fill line by a centrifugal field radiating from the chip’s rotation axis cures the objection and limits the line to a concentric arc.
Applicant’s argument is not persuasive because the amendment supplies an axis of a possible surface, but concentric arcs at multiple radial positions remain possible within a chamber as a centrifugal field is an area of force applied over the entirety of the chip, not a particular arced line such as suggested by Applicant’s Fig. 2, which is again dependent on liquid being present ion the chip and the chip being rotated by a centrifuge, wherein the present claim is drawn to a device not allowing patentable weight to such process-dependent limitations (MPEP 2114(II)).
35 USC 103
Applicant’s argument is on the alleged grounds that Lin and Duncombe do not describe Applicant’s cell-culture, humidification, or gas-perfusion application.
Applicant’s argument is not persuasive because the claims are directed to a microfluidic chip, and a difference in the disclosed use does not distinguish an otherwise qualifying chip capable of the recited functions. — See MPEP § 2114. — Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).
Applicant’s argument is on the alleged grounds that Lin has an identifiable rotation axis and therefore its chamber fill lines cannot be assigned anywhere convenient to the rejection.
Applicant’s argument is not persuasive because the axis position is indefinitely provided as discussed above. Further, Lin expressly defines “interior” and “exterior” relative to that center ([0050]), the amendment to Claims 1 and 2 do not, however, assign a particular fill volume or radial level; each cited opening must be assessed against a consistent, reasonable fill level rather than an arbitrarily chosen one as indicated by the “nominal fill line”. Applicant would need to provide very particular structural designations to the axis position with high specificity to achieve the intended chip organization, which would be highly limiting.
Applicant is suggested to describe the relative orientation of chambers functionally rather than with respect to a non-structural axis, such as by reciting the fluid flow and airflow between the chambers as configurations of the channels and chambers. Applicant may wish to cancel the pending claims and provide a new independent claim with high specificity given such centrifugal microfluidic chips are typical in the microfluidic art. While Applicant’s microfluidic chip may be intended for a particular use, the claimed chip remains a mere collection of channels, chambers, and openings. No new matter should be entered.
Applicant’s argument is on the alleged grounds that Lin’s air chamber only drives liquid and does not disclose Applicant’s sustained, controlled gas stream for humidification.
Applicant’s argument is not persuasive because Lin expressly discloses a gas-containing air chamber 430 connected with process chamber 420, compression of that gas, and restoration of its volume upon deceleration ([0045-0046]); thus, Applicant’s categorical assertion that Lin has no gas source communicating with the process chamber is incorrect. The claim is drawn to a device, a controlled gas stream for humidification is fully capable of being achieved in Lin. The actuated air into the chambers of Lin constitute movement of air.
Applicant’s argument is further on the alleged grounds that Lin lacks a port through which the alleged conditioned chamber vents excess gas.
Applicant’s argument is not persuasive because Lin expressly states that vents 480 release excess gas and may be provided on process chamber 420 according to design requirements ([0054]). The rejection relying on this teaching identifies a vent in fluid communication with the conditioned chamber—not a vent unable to release gas coming from the conditioned chamber.
Applicant’s argument is on the alleged grounds that Lin transfers valuable low-density fractions, which cannot be characterized as waste.
Applicant’s argument is not persuasive because Lin separately identifies waste chamber 470 and states that first test solution exceeding the detection chambers’ capacity enters it from overflow channel 440 ([0055]). The usefulness of material collected in detection chambers 450 does not negate Lin’s express disposal of excess liquid in chamber 470.
Applicant’s argument is on the alleged grounds that Lin’s subsidiary element 50 can be preloaded before sealing, so a port is not necessarily present.
Applicant’s argument is not persuasive because while preloading is a possible implementation, Lin expressly calls its constituent chamber 510A an injection chamber used to accept a second solution ([0067]); Applicant’s proposed sealed implementation does not erase the disclosed loading/injection function which necessarily requires a port to satisfy the injection method step of Lin.
Applicant’s argument is on the alleged grounds that adding a port would necessarily cause leakage or prevent Lin’s burst valves from working.
Applicant’s argument is not persuasive because Lin already incorporates vents to release gas and manage pressure ([0054]), and the burst valve described at [0065] is a particular connection between metering and reaction chambers, not a prohibition on every chamber loading port. Applicant has not shown that an axis-proximal port positioned above the operating liquid level necessarily opens that burst-valve connection or defeats its threshold.
Applicant’s argument is on the alleged grounds that a port element, separated from the alleged second chamber by a channel, does not literally meet a first opening of the second chamber.
Applicant’s argument is not persuasive because the claim does not require the port element be specifically connected directly to the second chamber. The phrase “of the second chamber” is interpreted broadly as including in fluid communication with the second chamber so as to relieve built-up pressure therein.
Applicant’s argument is on the alleged grounds that Lin’s second chamber lacks the particular combination of a spillway-delimited fill line, an axis-proximal port opening, an axis-proximal second-channel opening, and no distal channel opening.
Applicant’s argument is not persuasive because merely listing the features Lin lacks expressly does not dispose of a § 103 rejection that identifies each difference and a reason to modify the chamber not otherwise disclosed by Lin; Lin teaches that its chamber and channel configurations can vary with test requirements ([0056, 0059]). Further, as discussed above, the “axis proximal” and “axis distal” are broadly interpreted herein so as to satisfy Applicant’s disputed structural requirements given that, as discussed above, the axis position is indefinitely defined.
Applicant’s argument is on the alleged grounds that Lin’s illustrated overflow channel does not pass closer to the axis than process chamber 420 and that inserting such a siphon would stop Lin’s transfer of light fractions.
Applicant’s argument is not persuasive because it assumes that the existing liquid-transfer channel must be rerouted: a proposed, separate gas-supply channel can pass axis-proximal of both chambers while Lin’s overflow channel 440 remains available for its disclosed liquid transfer to detection chambers 450 and waste chamber 470.
Applicant’s argument is on the alleged grounds that a gas-control port and a reagent-loading port serve different purposes, and that the Office improperly dismissed the resulting advantages because they are not recited verbatim in the claims.
Applicant’s argument is not persuasive because different uses of a port do not alone establish that its claimed port structure would have been nonobvious or different than that of Lin. If Applicant wishes specific functions of the ports, Applicant must claim the structurally distinguishing features which render the ports suitable for a tight gas or liquid connection. Assertions of unexpected performance must be accompany an evidentiary basis, a connection to the claimed distinction, and scope commensurate with the claims — See MPEP §§ 2144.04(VI)(C), 2145. Herein, applicant has not provided such evidence of unexpected results.
Applicant’s argument is on the alleged grounds that the Office treated nominal fill lines as having no patentable weight and therefore failed to consider the dependent claims’ specific relationships.
Applicant’s argument is not persuasive because a nominal fill-line relationship is solely nonstructural, the fill line is not particularly oriented within the device. Applicant’s general disagreement with the remaining dependent rejections, without identifying a further particular error in those mappings, provides no additional basis to withdraw them.
Applicant’s argument is on the alleged grounds that Lin’s word “injected” necessarily implies forceful loading through a septum and excludes an ordinary loading opening.
Applicant’s argument is not persuasive because Lin describes solutions injected into its injection chambers before operation without requiring the particular septum construction Applicant proposes ([0067, 0086-0087]). As sample liquid is passed through the septum, the septum itself also acts as a sealable port necessarily fitting into a port opening to seal the device and prevent leaks.
Applicant’s argument is on the alleged grounds that an opening from a specified chamber to a specified channel cannot be replaced with any route by which fluid eventually communicates with a vent or port.
Applicant’s argument is not persuasive because the Examiner need not require a separately labeled aperture in Lin’s drawing, but must identify the physical chamber-to-channel junction or the junction the articulated modification creates. Applicant’s stricter labeling requirement is unpersuasive; its objection to using remote communication as though it were a chamber opening fails to negate the already present openings and wherein rearrangement of those openings would not result in any material difference of operation.
Applicant’s argument is on the alleged grounds that the Office must draw a complete modified chip to establish that all proposed changes are physically realizable and motivated.
No drawing is a prerequisite to a § 103 rejection, and Lin expressly permits variation in the number, structure, and configuration of its elements ([0056, 0059]). The Office must identify each necessary change, why a skilled artisan would make it, and why the combined arrangement would predictably operate; general design flexibility alone does not supply those findings — this is satisfied above in the body of the rejection.
Applicant’s argument is on the alleged grounds that its amendment now expressly excludes using the same channel for both the second and third channels.
Applicant’s argument is not persuasive because the separate portions forming the two distinct channels are separated by the off-shooting detection chamber and venting channel arrangements which physically separate the channels walls from one another. Further, the phrase “entirely physically separate from” is indefinitely understood under 35 USC 112(b) and is considered new matter under 35 USC 112(a). Further, Applicant’s amendment does not specify the second channel being separate from the third channel. Applicant’s amendment to Claim 1 recites “[the second channel] is entirely physically separate from the second channel”.
In general, Applicant’s arguments are drawn to orienting channels and chambers relative to positions which are undefined, such as the axis and fill lines, and relative to a centrifugal force field wherein such field is not only a non-existent force, not such “force field” being present (rather, centripetal force is the force experienced by liquid in the chip, any centrifugal force being merely perceived/apparent force), wherein such centrifugation is a process which has no basis in a device claim.
Thus, Examiner maintains the rejection of Claims 1-2, 4, 9, 12-13, 16-18, 21-23, and 25-30 under 35 USC 103 as being unpatentable over at least Lin, and as evidenced through Duncombe.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
