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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March6 has been entered.
Status of Objections and Rejections
The rejection of claim(s) 2 and 7-9 is/are obviated by Applicant’s cancellation.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment. New grounds of rejection are necessitated by the amendments.
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.
Claim(s) 1, 3-6, 10-11, 13-17, 19-25, and 28-39 is/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “the internal gap configured as a flow path extending between the inlet port and the outlet port for providing a substantially continuous flow that is independent of electrowetting-induced droplet movement for maintaining the flow path” which is not disclosed in the specification and is deemed to be new matter. The specification only discloses the cartridge is configured to provide the flow through the cartridge as a continuous flow and/or to substantially maintain a volume equilibrium in the cartridge (PGpub ¶11), and the flow through the internal gap as a substantially continuous flow and/or maintaining a volume equilibrium (¶67). There is no disclose that the flow path inside the internal gap is independent of electrowetting-induced droplet move movement for maintaining the flow path.
Subsequent dependent claims 3-6, 10-11, 13-17, 19-25, and 28-39 are rejected for their dependencies on rejected base claim 1.
Claim 11 recites the limitation “the liquid further comprises at least two processing liquids of different composition separated by the carrier liquid” which is not disclosed in the specification and is deemed to be new matter. The specification only discloses a processing liquid 61 can be any kind of liquid or liquid composition (¶125), and depending on the flow of the carrier liquid 60 towards the T-shaped junction 88 and the feeding of different processing liquids 61 into the tube towards that junction 88 (¶135), but there is no disclose that two different composition processing liquid separated by the carrier liquid.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-6, 10, 13-17, 19-25, 31-33, 36-37, and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (Y. Liu, Precise droplet volume measurement and electrode-based volume metering in digital microfluidics, Microfluid Nanofluid, 2014 (17), page 295-303).
Regarding claim 1, Liu teaches a method for operating a microfluidic droplets within a cartridge (Fig. 1: EWOD device; page 295, Col. 2, para. 1, lines 3-4: in digital microfluidics, droplets are manipulated on the surface of an insulated electrode array by electrowetting; as evidence by Marriam-Webster Dictionary, a cartridge is a case or container that holds a substance, device, or material which is difficult, troublesome, or awkward to handle and that usually can be easily changed; thus the EWOD device is deemed to be a cartridge) that comprises an internal gap (Fig. 1: inlets/outlets; e.g., Fig. 3: internal gap of the horizontal channel), an inlet port (Fig. 3: the junction between the vertical EW channel and the horizontal channel) for introducing a liquid (Fig. 3: the vertical EW channel; Fig. 2: the liquid inside the internal gap and between the inlet and outlet) that comprises a processing liquid (Fig. 2: aqueous solution) and a carrier liquid (Fig. 2: oil) for separating parts of the processing liquid (Fig. 3(d): the droplet is separated from the EW channel), an outlet port (Fig. 3: the left end of the horizontal channel; Fig. 1: the outlet of the side channel), and at least one hydrophobic surface (page 297, Col. 1, para. 1, lines 14-16: a layer of superhydrophobic fluoropolymer was dip-coated on both top-and bottom-glass substrates) enabling an electrowetting-induced movement of microfluidic droplets (page 297, Col. 1, para. 2, lines 12-15: flowing formation of the electrowetting channel, the side electrode arrays of different sizes enabled splitting droplets of various volumes from the channel; thus the hydrophobic surface of the electrowetting channel is one of the factors that enable the droplet formation), the internal gap configured as a flow path extending between the inlet port and the outlet port for providing a substantially continuous flow that is independent of electrowetting-induced droplet movement for maintaining the flow path (p. 297, col. 2, para. 1: a primary electrowetting virtual channel was first formed on the main electrode as a replenishable fluid source for droplet splitting with improved volume consistency; thus the internal gap of the horizontal channel of Fig. 3 would maintain a substantially continuous flow till the outlet of the horizontal channel), the method comprising the step of:
introducing an input liquid into the internal gap (Fig. 3(a): indicating the input liquid in the EW channel enters into the horizontal channel via the junction);
providing the microfluidic droplets of or separated from the liquid (Fig. 3(e)); and
transferring the carrier liquid (Fig. 1-2: the oil) from the inlet port to the outlet port via the internal gap (Fig. 2-3: indicating the fluid, including both oil and the aqueous solution, introduced into the internal gap of the horizontal channel via the junction) by applying a liquid driving force (p. 297: Overdosing the channel was necessary to ensure a consistent Laplace pressure and therefore consistent volume splitting) to at least a part of the input liquid (Fig. 3: indicating the droplet splitting from the continuous electrowetting EW channel) for providing a substantially continuous flow through the internal gap by substantially maintaining a volume equilibrium in the cartridge (Fig. 1: from the inlet to the outlet through both the main channel and the side channels) and moving the microfluidic droplets in the internal gap by the electrowetting-induced droplet movement (Fig. 3(c)-(e): activating and deactivating electrodes for droplet splitting).
Regarding claim 3, Liu teaches wherein the liquid driving force is a pressure force (Fig. 1; p. 297: Overdosing the channel was necessary to ensure a consistent Laplace pressure and therefore consistent volume splitting; thus, the liquid in the vertical EW channel is driven by pressure into the side horizontal channel).
Regarding claim 4, Liu teaches wherein the electrowetting-induced movement is provided by a plurality of electrodes (Fig. 1-2; p. 296, col. 2, last para., ll.8-10: four-side electrode arrays orthogonal to the main electrode for droplet splitting).
Regarding claim 5, Liu teaches wherein the electrowetting-induced movement is provided by an electrode array (Fig. 1-2; p. 296, col. 2, last para., ll. 8-10: four-side electrode arrays orthogonal to the main electrode for droplet splitting).
Regarding claim 6, Liu teaches wherein the driving force is provided by a two-dimensional electrode array (Fig. 1: the four-side electrode arrays constitute a two-dimensional electrode array).
Regarding claim 10, Liu teaches wherein the input liquid comprises an electrowetting filler liquid (Fig. 2: the processing liquid, oil, is an electrowetting filler liquid).
Regarding claim 13, Liu teaches wherein the processing liquid that comprises a washing liquid (p. 302, col. 2, last para.: sample volumes, such as buffer washing solution).
Regarding claim 14, Liu teaches a method for operating a cartridge (Fig. 1: EWOD device; page 295, Col. 2, para. 1, lines 3-4: in digital microfluidics, droplets are manipulated on the surface of an insulated electrode array by electrowetting; as evidence by Marriam-Webster Dictionary, a cartridge is a case or container that holds a substance, device, or material which is difficult, troublesome, or awkward to handle and that usually can be easily changed; thus the EWOD device is deemed to be a cartridge) for use in an electrowetting sample processing system (p. 297, col. 2, para. 1, ll.4-6: a yellow conducting fluid was introduced at one end of the main electrode using a syringe pump; here the EWOD device, the syringe pump, the AC power source in Fig. 2, and all other components are together deemed to be the electrowetting sample processing system), the cartridge comprising an internal gap (Fig. 1: inlets/outlets; e.g., Fig. 3: internal gap of the horizontal channel), an inlet port (Fig. 3: the junction between the vertical EW channel and the horizontal channel) for introducing a liquid (Fig. 3: the vertical EW channel; Fig. 2: the liquid inside the internal gap and between the inlet and outlet) that comprises a processing liquid (Fig. 2: aqueous solution) and a carrier liquid (Fig. 2: oil) for separating parts of the processing liquid (Fig. 3(d): the droplet is separated from the EW channel), an outlet port (Fig. 3: the left end of the horizontal channel; Fig. 1: the outlet of the side channel), and at least one hydrophobic surface (page 297, Col. 1, para. 1, lines 14-16: a layer of superhydrophobic fluoropolymer was dip-coated on both top-and bottom-glass substrates) enabling an electrowetting-induced movement of microfluidic droplets (page 297, Col. 1, para. 2, lines 12-15: flowing formation of the electrowetting channel, the side electrode arrays of different sizes enabled splitting droplets of various volumes from the channel; thus the hydrophobic surface of the electrowetting channel is one of the factors that enable the droplet formation), the internal gap configured as a flow path extending between the inlet port and the outlet port for providing a substantially continuous flow that is independent of electrowetting-induced droplet movement for maintaining the flow path (p. 297, col. 2, para. 1: a primary electrowetting virtual channel was first formed on the main electrode as a replenishable fluid source for droplet splitting with improved volume consistency; thus the internal gap of the horizontal channel of Fig. 3 would maintain a substantially continuous flow till the outlet of the horizontal channel), the method comprising the step of:
introducing an input liquid into the internal gap (Fig. 3(a): indicating the input liquid in the EW channel enters into the horizontal channel via the junction);
providing the microfluidic droplets of or separated from the liquid (Fig. 3(e)); and
transferring the carrier liquid (Fig. 1-2: the oil) from the inlet port to the outlet port via the internal gap (Fig. 2-3: indicating the fluid, including both oil and the aqueous solution, introduced into the internal gap of the horizontal channel via the junction) by applying a liquid driving force (p. 297: Overdosing the channel was necessary to ensure a consistent Laplace pressure and therefore consistent volume splitting) to at least a part of the input liquid (Fig. 3: indicating the droplet splitting from the continuous electrowetting EW channel) for providing a substantially continuous flow through the internal gap by substantially maintaining a volume equilibrium in the cartridge (Fig. 1: from the inlet to the outlet through both the main channel and the side channels) and moving the microfluidic droplets in the internal gap by the electrowetting-induced droplet movement (Fig. 3(c)-(e): activating and deactivating electrodes for droplet splitting).
Regarding claim 15, Liu teaches wherein the cartridge comprises a first part (Fig. 2: the top ITO glass substrate) with the inlet port (Fig. 2: inlet) and a second part (Fig. 2: the bottom substrate) attached to the first part (Fig. 2: showing the bottom substrate is attached to the top ITO glass substrate through the spacer), such that the gap is formed between the first part and the second part (Fig. 2: showing a gap between the top ITO glass substrate and the bottom substrate).
Regarding claims 16-17, Liu teaches wherein the first part comprises a rigid body (Fig. 2: the top ITO glass substrate).
The limitations “and/or the second part comprises or is an electrode support element or a flexible film, in particular a polymer film and/or an electrically isolating film, and wherein the second part is attached to a peripheral side structure of the first part” in claim 16, “wherein the second part comprises or is a flexible film” in claim 17 are optional and not required in the prior art reference.
Regarding claim 19, Liu teaches wherein the gap is defined by a spacer arranged between the first part and the second part (Fig. 2: showing the bottom substrate is attached to the top ITO glass substrate through the spacer between the two parts).
Regarding claim 20, Liu teaches wherein the gap is defined by a shape of at least one of the first part and the second part of the cartridge (Fig. 2: showing the shapes of the first part and the second part, i.e., the top ITO glass substrate and the bottom substrate defining the gap).
Regarding claim 21, Liu teaches wherein the first part comprise an outlet port (Fig. 2: showing the top ITO glass substrate comprises the outlet).
Regarding claims 22-23, Liu teaches wherein the applied liquid driving force provides a flow through the cartridge as a continuous flow and wherein the applied liquid driving force substantially maintains a volume equilibrium in the cartridge (p. 297: Overdosing the channel was necessary to ensure a consistent Laplace pressure and therefore consistent volume splitting; thus, the liquid in the vertical EW channel is driven by pressure into the side horizontal channel; Fig. 1: from the inlet to the outlet through both the main channel and the side channels; p. 296, col. 2, para. 1, ll. 5-6: nanoscale droplets were repeatedly generated from the sample supply channel with no degradation in volume consistency; thus, the fluid volume under the applied driving force is in equilibrium).
Regarding claims 24-25, Liu teaches wherein the cartridge comprises a plurality of electrodes for applying an electrowetting force to the microfluidic droplets and wherein the cartridge comprises an electrode array for applying an electrowetting force to the microfluidic droplets (Fig. 1-2; p. 296, col. 2, last para., ll. 8-10: four-side electrode arrays, each comprising a plurality of electrodes, orthogonal to the main electrode for droplet splitting).
Regarding claim 31, Liu teaches wherein the input liquid comprises a processing liquid (Fig. 2: aqueous fluid).
Regarding claims 32-33, Liu teaches wherein the cartridge comprises at least one liquid removal element that is operably connected to the outlet port (Fig. 1: as annotated, showing a liquid removal element operably connected to the outlet) and wherein the liquid removal element is a removal line (as annotated, showing the liquid removal element is a removal line).
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Regarding claim 36, Liu teaches wherein the first part comprises a polymer film (p. 297, col. 1, para. 1: a superhydrophobic fluoropolymer was dip-coated on both top- and bottom-glass substrates).
Regarding claim 37, Liu teaches wherein the liquid comprises a processing liquid that comprises a buffer (p. 302, col. 2, last para.: sample volumes, such as buffer washing solution).
Regarding claim 39, Liu teaches wherein the step of introducing of the liquid into the internal gap comprises a sequential feed and/or an alternating feed of the processing liquid and the carrier liquid (Fig. 2-3; p. 297, col. 1, last para.: the sequential feed of the oil and then the solution).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu.
Regarding claim 28, Liu discloses all limitations of claim 14 as applied to claim 14, but fails to teach wherein the cartridge comprises only one inlet port.
However, Liu teaches the continuous virtual channel as a replenishable fluid reservoir (p. 296, col. 2, last para.) only has one inlet and one outlet (Fig. 1: the main channel). The four side channels comprises four-side electrode arrays orthogonal to the main electrode for droplet splitting (p. 296, col. 2, last para.) or other digital functionalities (Fig. 1: mixing and/or merging).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Liu by substituting all four side channels with ones for splitting that splits droplets from the continuous electrowetting channel and moves toward the outlets (Fig. 3) as suggested because the EWOD device would generate nanoliter droplet from the continuous electrowetting channel used as a replenishable fluid reservoir which compensates for the loss of reservoir volume as droplets are sequentially split to improve volume consistency, especially for applications requiring multi-droplet generation (p. 295, [Abstract]). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have substituted other digital functionalities (e.g., mixing and merging) with the one of splitting and then the combined the elements with four splitting side channels as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Hadwen (US 2017/0059523).
Regarding claims 29-30, Liu discloses all limitations of claim 14 as applied to claim 14, but fails to teach wherein the cartridge is removably attachable to the electrowetting sample processing system (claim 29) or wherein the cartridge is disposable (claim 30).
However, Hadwen teaches a cartridge containing a microfluidic AM-EWOD device for glucans test (¶252). The test may be implemented in a cheap and disposable microfluidic device and thus suitable for application at Point of Care (¶254) which provides the testing rapid turnaround to results, low cost and ease and convenience (¶255). Here, a disposable cartridge would necessarily be removably attachable to the electrowetting sample processing system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Liu by substituting its cartridge, i.e., the EWOD device, with a disposable one because the disposable and/or removable EWOD device is cheap and suitable for application at Point of Care (¶254) which provides the testing rapid turnaround to results, low cost and ease and convenience (¶255).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Lay (US 2014/0190832).
Regarding claim 34, Liu discloses all limitation of claim 14 as described to claim 14, but fails to teach wherein the cartridge comprises a pressure compensation outlet or an air ventilation outlet for providing a fluid output arranged separate from the outlet port.
However, Lay teaches the cover 58 of the disposable cartridge 2 may comprise at least one ventilation duct 59 that is configured to let pass air (or other gases) arriving from the absorptive cushion 55 and thereby to avoid any building up of overpressure (Fig. 6; ¶90).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Liu by incorporating an air ventilation outlet that is arranged separate from the outlet port as taught by Lay because the ventilation outlet would let pass air to avoid any building up of overpressure (¶90).
Claim(s) 35 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of in view of Feiglin (WO 2014/187488).
Regarding claims 35 and 38, Liu discloses all limitations of claims 13 and 14, respectively, but fails to teach wherein the processing liquid comprises a suspension of magnetic beads, single cells, or cell aggregates.
However, Feiglin teaches a digital microfluidics system for manipulating samples in liquid droplets ([Abstract] lines 1-2). The digital microfluidics system may include optional modulus such as an optics module 48 for optical detection or a magnet actuator module 50 for attracting magnetic beads integrated into the digital microfluidics system for analysis of samples (Fig. 9; p. 26, ll. 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Liu by incorporating a suspension of magnetic beads in the processing liquid as taught by Feiglin because it would enable to use magnetic force for sample analysis in the digital microfluidic system (Fig. 9; p. 26, ll. 7-10). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). Further, applying a known technique to a known method ready for improvement to yield predictable results is prima facie obvious. MPEP 2141(III)(D).
Response to Arguments
Applicant’s arguments has/have been considered but are not persuasive.
Examiner notes that Applicant introduces new matter into the amended claims, which are not included in the disclosure as filed. Applicant is requested to point out the support for the instant amendment and all subsequent amendments.
Applicant argues the oil in Liu functions as a filler liquid occupying the cavity and enable formation of the virtual channel, rather than as a carrier liquid that separates portions of a processing liquid (Response, p. 9, last para.). Applicant further argues the droplet splitting is using side electrodes, and the main channel itself contains continuous fluid rather than droplets derived from or separated from the introduced liquid within the flow path extending between the inlet a d outlet ports (p. 10, para. 1) because the main channel is driven by pressure and the droplet splitting is driven by side electrodes (p. 10, para. 3). This arguments are unpersuasive. The main channel includes a continuous flow of carrier liquid and processing liquid, and the overdose of the liquid in the main channel would cause the liquid into the side channel. Thus, the liquid enters the side channel by pressure and the droplet splitting by electrowetting force.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C. SUN/Primary Examiner, Art Unit 1795
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