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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claim 1-15; and species A1, B1, C3, D1, E2, F2, G2, H2, I1, and J1 in the reply filed on 11/24/2025 is acknowledged.
Claims 1-15 are being examined.
Claim Objections
Claim 13 is objected to because of the following informalities: “and/ ”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-3, 8, 12, 13, 15 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 1 is unclear reciting “mixing/testing” because it is unclear if the applicant is claiming mixing and testing, mixing and/or testing, or mixing or testing.
Claim 1 is unclear reciting “wherein the set of conductive tiles (e.g., pads) terminates at a set of corresponding conductive-tile array located at an interface region on the fluidic plate; a self-testing circuit having electronics configured to assess operative contact between (i) the conductive-tile array and (ii) driving circuits configured to actuate the set of conductive tiles to move or mix fluid along the fluidic plate” because a set of corresponding conductive-tile array, an interface region, and driving circuits have not been positively claimed. In addition, it is unclear what is configured to assess operative contact between (i) the conductive-tile array and (ii) driving circuits, and what is configured to actuate the set of conductive tiles to move or mix fluid along the fluidic plate. Further, the “self-testing” is unclear if the applicant is trying to claim a structure or function.
Claims 1-3, 8, 12, 13, 15 are unclear reciting “configured [...]”, “being configured”, “pre-configured [...]” because it is unclear what structural configurations are being claimed, and whether the limitations following the phrase are part of the claimed invention.
Regarding claim 1, the phrase "e.g.," renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "e.g.,"), thereby rendering the scope of the claim(s) unascertainable.
Claim 1 recites the limitation "the conductive-tile array" in L12. There is insufficient antecedent basis for this limitation in the claim.
In claim 12, the term “natural” is unclear.
Claim limitation “configured” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-13 & 15 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Soto-Moreno et al. (US 2022/0219172 A1).
Regarding claim 1, Soto-Moreno et al. teach:
1. A system comprising:
a base system (e.g., controller ¶ 0044; see also system 5701, controller 5715 in Fig. 57);
a cartridge (see ¶ 0009-0012+; e.g., cartridge 363, 700, 5705) to couplable to the base system (see Fig. 57 for example), wherein the cartridge includes:
housing (e.g., top plate ¶ 0009, cover 703 ¶ 0289);
a microfluidic electrode assembly (see e.g., ground electrode 102, actuation electrode layer 105, actuation electrodes 106 in Figs. 1B-1C) comprising:
a fluidic plate (e.g., bottom plate 151) having two or more mixing/testing regions (e.g., sample reservoir 110, reagent reservoirs 111, reaction zone 112 ¶ 0270-0271 & Figs. 1A-1C; see also Figs. 6, 26, 55A-55B);
a set of conductive tiles (e.g., unit cells 191 Fig. 1A & ¶ 0268; driving electrodes 211 Fig. 2 & ¶ 0276) disposed along the fluidic plate that connects between the two or more mixing/testing regions (see i.e., functional zones for providing an aliquot of solution, mixing a solution, and/removing solutions may be formed into the cartridge ¶ 0296; and Figs. 1A & 2 for example), wherein the set of conductive tiles terminates at a set of corresponding conductive-tile array located at an interface region on the fluidic plate (see Figs. 1A-2 for example);
a circuit having electronics capable of being in operative contact between (i) the conductive-tile array (see i.e. The DMF apparatuses described herein typically include a controller for coordinating and driving the electrodes. This controller may include one or more processors, memory, and any other circuitry necessary or useful for operating the device, including coordinating the application of energy to activate/inactivate the drive electrodes, the pump(s) for vacuum and/or microfluidic control, one or more valves (e.g., for microfluidic control, vacuum control), temperature control (e.g., resistive heater, Peltier cooling, etc.) the motor(s) (e.g., for driving opening and closing the device door, the optics, etc.), one or more displays, etc. ¶ 0044) and (ii) driving circuits (e.g., drive electrodes ¶ 0044+) capable of actuating the set of conductive tiles to move fluid along the fluidic plate (see ¶ 0007, 0036-0037 for example).
With regard to limitations in claims 1-3, 8, 12, 14, 15 (e.g., to assess operative contact [...] to actuate the set of conductive tiles to move fluid along the fluidic plate; [...] being configured to also assess [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-13 & 15, Soto-Moreno et al. teach:
2. The system of claim 1 further comprising at least one sensing tile disposed along the fluidic plate adjacent to or integrated with the set of conductive tiles, wherein the at least one sensing tile terminates (i) at the set of corresponding conductive-tile array, the circuit capable of being in operative contact of the conductive-tile array associated with the sensing tile (see i.e., For example a method of detecting the location and/or identity may include: disconnecting a reference electrode on a first side of the air gap of the DMF cartridge from a driving circuit; setting the voltage of one or more drive electrodes of an array of drive electrodes on a second side of the air gap to a high voltage while setting all other drive electrode of the array of drive electrodes to ground; sensing the voltage at the reference electrode; determining a capacitance between the first side of the air gap and the second side of the air gap based on the voltage sensed at the reference electrode; and identifying the material in the air gap adjacent to the one or more drive electrodes based on the determined capacitance. The method may also include reconnecting the reference electrode to the driving circuit, and driving a droplet within the air gap by applying a voltage between the reference electrode and one the drive electrodes. These steps may be repeated iteratively, to track movement of material in the air gap. ¶ 0074-0075).
3. The system of claim 1 further comprising a biosensor disposed (ii) inside one of the two or more mixing/testing regions, wherein the biosensor electrically terminates (i) at the set of corresponding conductive-tile array, the circuit being capable of assessing contact of the conductive-tile array associated with the biosensor (see i.e., For example a method of detecting the location and/or identity may include: disconnecting a reference electrode on a first side of the air gap of the DMF cartridge from a driving circuit; setting the voltage of one or more drive electrodes of an array of drive electrodes on a second side of the air gap to a high voltage while setting all other drive electrode of the array of drive electrodes to ground; sensing the voltage at the reference electrode; determining a capacitance between the first side of the air gap and the second side of the air gap based on the voltage sensed at the reference electrode; and identifying the material in the air gap adjacent to the one or more drive electrodes based on the determined capacitance. The method may also include reconnecting the reference electrode to the driving circuit, and driving a droplet within the air gap by applying a voltage between the reference electrode and one the drive electrodes. These steps may be repeated iteratively, to track movement of material in the air gap. ¶ 0074-0075).
4. The system of claim 1 further comprising a dielectric material (e.g., dielectric layer/material) disposed between elements of the set of conductive tiles (see ¶ 0009-0012+ for example).
5. The system of claim 1 further comprising a magnetic focusing region (e.g., magnetic zones 603) for the fluidic plate or the set of conductive tiles, the magnetic focusing region being defined by a field from a magnet and a magnetic focusing structure disposed adjacent or in proximity to the magnetic region (see Fig. 6 & ¶ 0295 for example).
6. The system of claim 5 wherein the magnetic focusing structures comprises a magnetic field guide (see i.e., the magnetic field may pass through an opening in the drive electrode ¶ 0072).
7. The system of claim 1, wherein the two or more mixing/testing regions comprises a sample reservoir (¶ 0268, 0272), an outlet reservoir (e.g., waste reservoir ¶ 0030, 0318), and at least one intermediate reservoir (e.g., reagent reservoirs ¶ 0268, 0272), each disposed adjacent to or along the set of conductive tiles or the interface region of the fluidic plate (see i.e., sample reservoir 110, reagent reservoirs 111, reaction zone 112 in Fig. 1A & ¶ 0270-0271; four reservoir regions 203, 205, 207, 209 in Fig. 2 & ¶ 0276).
8. The system of claim 7, wherein the at least one intermediate reservoir comprises a buffer solution capable of being introduced into one of the two or more mixing/testing regions (see i.e., These regions may also be used to store solution [...] ¶ 0295; The small amount of aqueous liquid in the jacketing droplet may be a buffer, diluent, or other solution that allows the jacketing droplet to be moved in the air gap. ¶ 0319; FIGS. 26A-26H illustrate one example of an apparatus determining a pathway from an input protocol. For example, FIG. 26A shows a graphical illustration of a particular configuration of DMF cartridge air-gap planning a first set of steps, e.g., sample preparation. The apparatus may know the distribution of the cells within the air gap, as well as the configuration of the functional zones (heaters, coolers, mixing/microfluidics, waste removal, dispensing, etc.) in the DMF cartridge. FIG. 26B is a graphical illustration of the apparatus determining the path for tagging a sample having genomic DNA (or fragments of DNA) with an adapter tag. In FIG. 26C, a step of moving a first buffer (e.g., SureSelect QXT buffer) to an appropriate location for future processing is performed. The path may be chosen in light of both past movements and future movements and may be recursively modified as the future protocol steps are defined. In FIG. 26D, the path for moving the DNA sample is shown (in black). FIG. 26E shows the movement of an enzyme mix from a cooled region where it is beings stored to combine with the sample; FIG. 26F shows the user of mixing of the sample with the buffer and enzyme mix. The mixed sample may then be moved (FIG. 26G) along a calculated pathway to a heating/cooling zone for cycling (FIG. 26H). Additional steps may then be performed as indicated. ¶ 0337).
9. The system of claim 7, wherein the at least one intermediate reservoir comprises a reagent to be introduced into one of the two or more mixing/testing regions for mixing with the sample solution (see i.e., These regions may also be used to store solution [...] ¶ 0295; The small amount of aqueous liquid in the jacketing droplet may be a buffer, diluent, or other solution that allows the jacketing droplet to be moved in the air gap. ¶ 0319; FIGS. 26A-26H illustrate one example of an apparatus determining a pathway from an input protocol. For example, FIG. 26A shows a graphical illustration of a particular configuration of DMF cartridge air-gap planning a first set of steps, e.g., sample preparation. The apparatus may know the distribution of the cells within the air gap, as well as the configuration of the functional zones (heaters, coolers, mixing/microfluidics, waste removal, dispensing, etc.) in the DMF cartridge. FIG. 26B is a graphical illustration of the apparatus determining the path for tagging a sample having genomic DNA (or fragments of DNA) with an adapter tag. In FIG. 26C, a step of moving a first buffer (e.g., SureSelect QXT buffer) to an appropriate location for future processing is performed. The path may be chosen in light of both past movements and future movements and may be recursively modified as the future protocol steps are defined. In FIG. 26D, the path for moving the DNA sample is shown (in black). FIG. 26E shows the movement of an enzyme mix from a cooled region where it is beings stored to combine with the sample; FIG. 26F shows the user of mixing of the sample with the buffer and enzyme mix. The mixed sample may then be moved (FIG. 26G) along a calculated pathway to a heating/cooling zone for cycling (FIG. 26H). Additional steps may then be performed as indicated. ¶ 0337).
10. The system of claim 7, wherein the at least one intermediate reservoir comprises an intermediate buffer solution (see i.e., These regions may also be used to store solution [...] ¶ 0295; The small amount of aqueous liquid in the jacketing droplet may be a buffer, diluent, or other solution that allows the jacketing droplet to be moved in the air gap. ¶ 0319; FIGS. 26A-26H illustrate one example of an apparatus determining a pathway from an input protocol. For example, FIG. 26A shows a graphical illustration of a particular configuration of DMF cartridge air-gap planning a first set of steps, e.g., sample preparation. The apparatus may know the distribution of the cells within the air gap, as well as the configuration of the functional zones (heaters, coolers, mixing/microfluidics, waste removal, dispensing, etc.) in the DMF cartridge. FIG. 26B is a graphical illustration of the apparatus determining the path for tagging a sample having genomic DNA (or fragments of DNA) with an adapter tag. In FIG. 26C, a step of moving a first buffer (e.g., SureSelect QXT buffer) to an appropriate location for future processing is performed. The path may be chosen in light of both past movements and future movements and may be recursively modified as the future protocol steps are defined. In FIG. 26D, the path for moving the DNA sample is shown (in black). FIG. 26E shows the movement of an enzyme mix from a cooled region where it is beings stored to combine with the sample; FIG. 26F shows the user of mixing of the sample with the buffer and enzyme mix. The mixed sample may then be moved (FIG. 26G) along a calculated pathway to a heating/cooling zone for cycling (FIG. 26H). Additional steps may then be performed as indicated. ¶ 0337).
11. The system of claim 7, wherein one of the sample reservoir, the outlet reservoir, or the at least one intermediate reservoir is adjacent to the interface region on the fluidic plate (see Figs. 1A, 2, 6, 26A-26H, 55A-55B for example).
12. The system of claim 1 further comprising an electrically-actuated non-mechanically moving valve disposed (i) along the set of conductive tiles, the electrically-actuated non-mechanically moving valve capable of restricting a fluid flow across the valve in an unactuated state and allowing flow of fluid across the valve when actuated (see i.e., In FIG. 6, the microfluidics channel also includes a pair of ports 617, 618 through which positive and/or negative pressure may be applied to modulate (along with any valves) the movement of fluid in the microfluidics region and (in some variations) into or out of the air gap. ¶ 0142).
13. The system of claim 1, the base system comprising: a microcontroller (e.g., one or more processors ¶ 0044, i.e., 309) in electrical communication with the cartridge (¶ 0044, 0367, 0402+); and a memory (¶ 0044, 0053, 0402+) in electrical communication with the microcontroller (¶ 0044, 0053, 0402); and a display interface and a display (¶ 0053, 0402, 0404+) in electrical communication with the microcontroller and configured to display information about the system (¶ 0367, 0402, 0404, 0434+).
15. The system of claim 7, wherein the system is capable of performing (ii) a DNA isolation protocol with magnetic beads (see ¶ 0049, 0446, 0470 for example).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soto-Moreno et al. (US 2022/0219172 A1) in view of Pollack et al. (US 2010/0282609 A1).
Regarding claim 14, Soto-Moreno et al. teach: 14. The system of claim 7, wherein the intermediate reservoir334 includes an integrated package assembly disposed on the fluidic plate (see Figs. 1A, 2, 6, 26A-26H, 55A-55B for example), the integrated package assembly having (i) a first region (see i.e., These regions may also be used to store solution [...] ¶ 0295) to hold a fluid (e.g., sample reservoir ¶ 0268, 0272) and (ii) a second region (see i.e., These regions may also be used to store solution [...] ¶ 0295) to hold an intermediate storage fluid (The small amount of aqueous liquid in the jacketing droplet may be a buffer, diluent, or other solution that allows the jacketing droplet to be moved in the air gap. ¶ 0319; FIGS. 26A-26H illustrate one example of an apparatus determining a pathway from an input protocol. For example, FIG. 26A shows a graphical illustration of a particular configuration of DMF cartridge air-gap planning a first set of steps, e.g., sample preparation. The apparatus may know the distribution of the cells within the air gap, as well as the configuration of the functional zones (heaters, coolers, mixing/microfluidics, waste removal, dispensing, etc.) in the DMF cartridge. FIG. 26B is a graphical illustration of the apparatus determining the path for tagging a sample having genomic DNA (or fragments of DNA) with an adapter tag. In FIG. 26C, a step of moving a first buffer (e.g., SureSelect QXT buffer) to an appropriate location for future processing is performed. The path may be chosen in light of both past movements and future movements and may be recursively modified as the future protocol steps are defined. In FIG. 26D, the path for moving the DNA sample is shown (in black). FIG. 26E shows the movement of an enzyme mix from a cooled region where it is beings stored to combine with the sample; FIG. 26F shows the user of mixing of the sample with the buffer and enzyme mix. The mixed sample may then be moved (FIG. 26G) along a calculated pathway to a heating/cooling zone for cycling (FIG. 26H). Additional steps may then be performed as indicated. ¶ 0337). However, Soto-Moreno et al. do not explicitly teach: the integrated package assembly having a pierceable covering.
Pollack et al. teach an integrated package assembly having a pierceable covering (e.g., protective foil ¶ 0097).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Soto-Moreno et al. with a pierceable protective foil, as taught by Pollack et al., to store different assay reagents suitable for use with a single standard droplet actuator (Pollack et al. ¶ 0097).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798