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 .
Claim Status
Claims 1, 3-18, and 20 are pending.
Claims 2 and 19 has been withdrawn.
Claim 1 is been amended.
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.
Claims 1, 3, and 11 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Ismagilov et. al. (WO 2015084458 A2).
Regarding Claim 1 Ismagilov teaches “A diagnostic device based on surface-enhanced Raman scattering, comprising:” (Abstract and Paras [00191], [00336], - Systems used with devices for assaying, processing, and/or storing samples including point-of care diagnostics. The detector present in the system or device can be Raman spectrometry.), “an inlet module receiving liquid to be analyzed;” (Claim 106, 108 and Para [00403], sample inlet port or sample input well. A liquid sample, such as blood, can be loaded in the device. Also, “a reaction module (sample preparation device) having a first region (first substrate) arranged with a receiving hole (sample input port) and a second region (Para [0020], one or more capture regions between the first and third substrates which are in fluid communication with at least one of the one or more first chambers) arranged with an output hole, (Para [00415], any of the devices, samples, analytes, or solutions can be retrieved from a device by connecting a chamber or series of chambers to inlet/outlet holes); wherein the receiving hole is communicated with the output hole exclusively through a single flow channel” (Claim 109, Paras [00269] and [00415], A sample preparation device having a first substrate comprising a sample input port and comprising one or more chambers situated within the first substrate, wherein the one or more chambers comprise a reaction chamber fluidly connected with the sample input port. The chambers so that they form a single path connected to one inlet and one outlet.) Therefore if a device having one of the one or more signal flow channels teaches to the exclusively through a signal flow channel. Further taught “configured with at least one chemical set,” (Claim 109, and Paras [00269], [0347], and [00348], a reagent which include: organic or inorganic chemical, a compound, a mixture, a solution, a biomolecule, a nanoparticle, a reaction product, a solvent, a buffer. The channels 750 which can be used for movement of samples, reagents, and other fluids. These reagents could also be included in any feature of the device, such as one or more chambers. Exemplary reagents include a particle, a nanoparticle, a reaction product pre-loaded with any useful reagents. These reagents could also be included in any feature of the device, such as one or more chambers, layers (including portions thereof, such as, e.g., the portion of the layer lacking one or more chambers), capture regions, bridges, and/or membranes. Furthermore, such reagents can be used in gas, liquid, or solid form, as well as in a coating on the one or more features or in a coating on one or more solid supports (e.g., beads, particles, etc.) within one or more features, where such features include, e.g., one or more chambers, layers (including portions thereof, such as, e.g., the portion of the layer lacking one or more chambers), capture regions, bridges, and/or membranes. Exemplary reagents include a mixture, a solution, an emulsion. Reagents can be stored (e.g., as in resistant unit 526) in a dried state and then reconstituted only upon activating the pushing unit. Storage in a dried state may be desired for increasing the shelf life of particular reagents (e.g., one or more buffers, proteins, reagents, etc.). Therefore, the reagents include mixtures and nanoparticle which are taught to be dried and coated on one or mor solid supports like beads which teaches to at least one chemical set.
The “reaction module receives the liquid delivered by the inlet module via the receiving hole,” taught in (Claim 108, An integrated device comprising: the reagent dispensing device wherein a sample input port is fluidly connected to at least one of the one or more chambers; and a detector attached to the reagent dispensing device; wherein the integrated device is configured to detect at least one biological molecule within forty minutes or less after a biological sample is loaded into the sample input port.). The “and the liquid to be analyzed flows through at least one chemical set placed in the signal flow channel to obtain nanoparticle-carrying liquid,” within (Paras [00269], [00347], [00348], and Claim 109, reaction chamber fluidly connected with the sample input port. Reagents could also be included in any feature of the device, such as one or more chambers. Exemplary reagents include a particle, a nanoparticle a reaction product). Therefore, having the reagents which include nanoparticles in the chamber and having the sample input port connected to the chamber obtains the nanoparticle-carrying liquid.
Also taught “and the nanoparticle-carrying liquid flows into the second region of the reaction module;” (Para [0020], the capture region disposed between the first and third substrates. Wherein the one or more capture regions are in fluidic communication with at least one of the one or more first chambers or, if present, with the process chamber, sample chamber, or elution chamber.) Having the capture region connected to the first substrate which has the nanoparticles-carrying liquid within the chamber teaches to the second region having the nanoparticle-carrying liquid flow into. The recitation “, wherein the at least one chemical set is dissolved by the liquid to be analyzed and the dissolved chemical set carries out a chemical reaction to generate nanoparticles and the liquid to be analyzed is mixed with the nanoparticles to obtain the nanoparticles- carrying liquid” is capability of chemical set and the liquid. Ismagilov discloses the positively claimed structural elements of the chemical set and liquid as claimed, such chemical set and liquid are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, (Paras [0020] teaches the chamber having a chemical that generates a reaction.) and as taught above the chamber having the nanoparticle reagent and the liquid gives the components for the chemical reaction to obtain nanoparticle-carrying liquid.
Further, “and a detection module receiving the nanoparticle-carrying liquid from the output hole of the reaction module,” (Claim 108 and 119, a detector attached to the reagent dispensing device which has the reagent mixed with sample flow through. An integrated device comprising: the sample preparation device of any one of claims and a detector attached to the sample preparation device.). The “wherein the output hole of the reaction module is a hole for receiving a laser light,” (Paras [0466] and [00315], The detector can comprise a laser sensor. The devices of the invention can include a hole.); “the laser light is configured to be irradiate to the nanoparticle-carrying liquid received by the detection module through the output hole, and the nanoparticle-carrying liquid is excited to generate the surface-enhanced Raman scattering.” Is a recitation of intended use of the apparatus. However, Ismagilov teaches (Paras [00337], [00434], [00466] The detector would only produce the excitation light when pointed at the device. Detection can also be improved by using the polarization of excited/emitted light, as is known to those skilled in the art. The analysis could be of small molecules, particles, biomineralization, nanoparticle formation. The detector can comprise a laser sensor. The sensors can comprise a single sensor or multiple sensors, of the same type or of different types. The detector can comprise a light source. The light source can comprise a laser. The light source can comprise filters for controlling the output wavelength or wavelengths. The polarization of excited/emitted light can happen, which is known in the art.); “wherein the at least one chemical set comprises a plurality of chemical reagents,” (Para [00348], Exemplary reagents include: a desiccant, an organic or inorganic chemical, a compound, a mixture, a solution, a molecule, a biomolecule, a particle, a nanoparticle, a reaction product, a solvent, a buffer.) Therefore the plurality of chemical reagents is taught by a mixture. Further taught “each chemical reagent is arranged in the single flow channel in the form of dried chemical spots,” (Paras [0026], [00402], reagents can be stored (e.g., as in resistant unit 526) in a dried state and then reconstituted only upon activating the pushing unit. Storage in a dried state may be desired for increasing the shelf life of particular reagents. A sample, either before or after processing or analysis, as well as any substance described herein (e.g., a reagent, a buffer, etc.) can be preserved or stored either in the dry state or in the liquid state.); “and the dried chemical spots are arranged at intervals in sequence.” (Paras [00480], [00269], [0347], and [00348, The present systems and methods can be implemented with a device to dispense one or more fluids/reagents in a controlled manner. A non-limiting example is provided in FIG. 6A-D. Furthermore, such reagents can be used in gas, liquid, or solid form, as well as in a coating on the one or more features or in a coating on one or more solid supports (e.g., beads, particles, etc.) within one or more features, where such features include, e.g., one or more chambers, layers (including portions thereof, such as, e.g., the portion of the layer lacking one or more chambers), capture regions, bridges, and/or membranes.) Therefore, dispensing reagents in a controlled manner teaches to the intervals in sequence. In addition, the dried reagents coated on one or more solid supports like beads also teaches to the intervals in sequence.
Regarding Claim 3 Ismagilov teaches all of claim 1 in addition, “wherein the at least one chemical set comprises a plurality of chemical sets, a number of the chemical sets is 3 or 4 ,” (Para [00509], [00515], and [00348], By "chamber" is meant a volumetric portion of a substrate capable of containing one or more substances, e.g., reagents. The "process chamber" a chamber for combining one or more fluids and/or one or more reagents; for containing one or more fluids and/or one or more reagents; for reacting one or more fluids and/or one or more reagents; for processing one or more fluids and/or one or more reagents; and/or for analyzing one or more fluids and/or one or more reagents. Exemplary reagents include a mixture.). In addition, this is a mere duplication of parts which has no patentable significance unless a new and unexpected result is produced. The plurality of chemical sets within the device does not produce an unexpected result. Therefore, this claim limitation lacks patentable significance. Ismagilov further teaches “and the chemical sets are arranged at intervals in sequence.” (Para [00480], [00269], [0347], and [00348, The present systems and methods can be implemented with a device to dispense one or more fluids/reagents in a controlled manner. A non-limiting example is provided in FIG. 6A-D via 621-623. Furthermore, such reagents can be used in gas, liquid, or solid form, as well as in a coating on the one or more features or in a coating on one or more solid supports (e.g., beads, particles, etc.) within one or more features, where such features include, e.g., one or more chambers, layers (including portions thereof, such as, e.g., the portion of the layer lacking one or more chambers), capture regions, bridges, and/or membranes.) Intervals in sequence in a controlled manner which can be seen in the Figures mentioned Therefore, dispensing reagents in a controlled manner teaches to the intervals in sequence. In addition, the reagents coated on one or more solid supports like beads also teaches to the intervals in sequence.
Regarding Claim 11 Ismagilov teaches all of claim 1 in addition “further comprising a filtration module, wherein the filtration module is disposed between the inlet module and the first region of the reaction module, to filter the liquid to be analyzed delivered by the inlet module.” (Claim 137, Para [00279] and Fig. 7A, The device can comprise a filter or matrix layer, through which sample material can be filtered. The filter or matrix layer can be disposed adjacent to or be in fluid communication with a reagent layer, allowing application of reagents, buffers, or other fluids to the filter. The sample material enters the device through the inlet which can be seen in Fig. 7A.) Therefore, in order for the filter to filter sample material it has to be placed after the inlet. In addition, the filter layer can be disposed in fluid communication with the reagent layer. Having both teaches to having the filtration module between the inlet and the reaction module.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov as applied to claim 1 above, and further in view of Unger et. al. (WO 2016074040), hereinafter Unger.
Regarding Claim 4 Ismagilov teaches all of claim 1 in addition, (Para [00234], Fluid or reagent from a resistant unit or barrier unit can be flowed through or dispensed via a channel or other conduit. The geometric parameters (e.g. length, width, height, diameter) of a channel can be designed to control the operation time. For example, a longer channel or a narrower channel can be characterized by a larger hydrodynamic resistance and can increase the amount of time for a fluid or reagent to dispense from a resistant unit or barrier unit, and can therefore prevent a pushing unit from proceeding for a longer amount of time.
Ismagilov fails to explicitly teach “wherein the diameter of the receiving hole is larger than the diameter of the output hole.”
Unger teaches (Page 4 lines 4-10, Preferably holes formed in one layer of the plurality of layers are aligned with holes in an adjacent layer so that a plurality of holes in a plurality of layers cooperate to form the micro channels. In some embodiments the holes decrease in diameter and increase in number from the first layer to the tissue-containing layer. The micro channels may have a varying cross-section along their length.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Unger wherein the diameter of the receiving hole is larger than the diameter of the output hole. Doing so can control the operation time for the device as taught in Ismagilov in addition can decrease the probability of air bubbles as taught in Kamen et. al. (US 9492606 B2).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et. al. (WO 2015084458 A2).
Regarding Claim 5 Ismagilov teaches all of claim 1 in addition, “wherein the reaction module comprises a first substrate” (Claim 109, Para [00413], A sample preparation device comprising: (a) a first substrate comprising a sample input port and comprising one or more chambers situated within the first substrate, wherein the one or more chambers comprise a reaction chamber fluidly connected with the sample input port; and b) at least one resistant unit adjacent to a surface of the first substrate, wherein the at least one resistant unit: (i) comprises a reagent and (ii) is in fluidic connection with at least one of the one or more chambers), “and a first thermoplastic film stack layer disposed on the first substrate,” (Paras [0012], [00222], [00224], [00302], [00305], and [00306], Resistant units, which are adjacent to (on) the substrate comprise blisters or blister packs. A blister pack can comprise variety of materials, including but not limited to metal, plastic, thermoplastic, paper, foil, film, membranes, and combinations thereof. A blister or blister pack can be formed using any useful method, including but not limited to laminating, folding, feeding, and/or cutting of one or more films, sheets, substrates, or layers. In some cases, a blister pack can include a top film and a bottom film, where the top and bottom films enclose one or more predetermined volumes. The substrates or layers can include any useful material. One or more resistant units disposed above the first substrate along the first surface.) “wherein a through groove is formed in the first thermoplastic film stack layer to form the single flow channel.” (Claim 109, para [00413], A sample preparation device comprising: a first substrate comprising a sample input port and comprising one or more chambers situated within the first substrate, wherein the one or more chambers comprise a reaction chamber fluidly connected with the sample input port; and at least one resistant unit adjacent to a surface of the first substrate, wherein the at least one resistant unit: comprises a reagent and is in fluidic connection with at least one of the one or more chambers. Grooves or other geometrical features can be included in the channel to create "capillary valves". Also, the motion of the layers relative to one another may be constrained by a case, posts, grooves. The exemplary chambers include an open groove or trench.) Therefore, the reagent from the resistant unit (which has the thermoplastic film) in fluid connection with the chambers which have grooves teaches to a through groove formed in the first thermoplastic film. Further taught “two holes are formed in the first thermoplastic film stack layer and are connected by the single flow channel”, (Paras [0026], and [0020], the resistant unit is configured to release the first reagent through the first through-hole into at least one of the one or more chambers after the cap is engaged and rotated. The first resistant unit is further fluidically connected to a fourth resistant unit comprising a fourth reagent, and wherein the first relative movement causes the first reagent to enter the fourth resistant unit, thereby combining the first and fourth reagents and causing the combination to enter at least one of the one or more first chambers.) Therefore the first through-hole teaches to one of the two holes and the fluidically connection to the fourth resistant unit which connects to the chambers teaches to the second of the two holes. The recitation “the receiving hole and the output hole are formed in the first substrate,” is already taught within claim 1 as above. Also taught “ the receiving hole is aligned with one hole of the two holes of the first thermoplastic film stack layer,” (Paras [0026], and [0020], the resistant unit is configured to release the first reagent through the first through-hole into at least one of the one or more chambers)
Ismagilov does not explicitly teach “and the output hole is aligned with the other hole of the two holes of the first thermoplastic film stack layer.”. However Ismagilov does teach that the “first thermoplastic film stack layer” the resistant unit comprise blister packs which are thermoplastic layers and layers and devices can have holes. (Paras [00222], [00224], [00302], [00305], and [00306], [00315], [00415], [00416], and Claim 108, Resistant units, which are adjacent to (on) the substrate comprise blisters or blister packs. A blister pack can comprise thermoplastic. The intermediate layers can have one or more openings. The devices of the invention can include one or more structural features, such as a substrate, a layer, a chamber (e.g., a well, a channel, a hole.) It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Ismagilov by having the output hole is aligned with the other hole of the two holes of the first thermoplastic film stack layer, since Ismagilov teaches layers and devices can have holes and having the output hole aligned with the second hole of the first thermoplastic film stack layer would allow fluid to be placed back in circulation to further assist in mixing with more reagent.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov as applied to claim 1 above, and further in view of Ming et. al. (Chopper-modulated gas chromatography electroantennography enabled using high-temperature MEMS flow control device, Published 12/18/2017), hereinafter Ming.
Regarding Claim 6 Ismagilov teaches all of claim 1 in addition, (Para [00269], [00487] and FIG. 7A a sample well with cap ; (part of inlet) and an elution outlet (which detector connects to) are both on the same side of the elution resistant unit 705 (part of reaction module).
Ismagilov does not explicitly teach “,wherein the inlet module and the detection module are arranged on the same side of the reaction module.”.
Ming teaches (Fig. 1, Injector (inlet) and FID (detector) same side as to the GC Column or oven which is where the reaction happens.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Ming wherein the inlet module and the detection module are arranged on the same side of the reaction module. Doing so would allow three sides of the device to be free of inports or outports such as the inlet and detector allowing for more flexibility in the placement of the device.
Claims 7, 8, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov as applied to claim 1 above, and further in view of: Wood et. al. (US 10697955 B2 ), Qian (US 20160097049 A1), Hirakata et. al. (US 10317809 B2), hereinafter Wood and Hirakata.
Regarding Claim 7 Ismagilov teaches all of claim 1 in addition, “wherein the detection module comprises two first single-layer thermoplastic films” (Paras [00302], [00305] ,[00297], and [00414] the device can include additional layers having any useful planarity, and each layer can have similar, different, or complementary structure characteristics (e.g., planarity). Moreover, to ensure that uniform pressure is applied over the first and second areas or layers, the surface may vary to ensure when pressure is applied in discrete locations along the device, a uniform pressure can be applied. The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis. In particular examples, the layers are provided in a stacked configuration having a top layer, a bottom layer, and a plurality of intermediate layers. The intermediate layers can have one or more openings and/or capture regions such that various chambers and/or capture regions are able to be connected by relative movement. For any of the devices described herein, the membrane can be integrated into the device using any useful method. Exemplary methods include but are not limited to bonding using glues or adhesives, bonding using adhesive tapes, bonding using techniques commonly used for thermoplastic materials. The substrates or layers can include any useful material.). Therefore, the plurality of layers in the device teaches to two single- layer as claimed and the thermoplastic materials teach to the thermoplastic films.
Ismagilov further fails to teach “a fiber glass filter paper”.
Wood teaches (Claim 2, placing plasma sample on glass filter paper; and wherein drying the plasma sample comprises drying the plasma sample on the glass filter paper. Where the method and system is for detection of disease agent in blood.) In addition, Qian teaches (Para, [0035] and [0036] A filter column with a solid phase extraction matrix inside, such as porous glass frit, or glass fiber filter paper, such as the exemplary filter column. The filter column substrate may comprise a column binding matrix comprising a solid matrix which allows fluid to pass through the matrix. In certain aspects the matrix is highly porous so as to maximize surface area exposed to buffer solutions and thereby maximize the binding capacity of the matrix. The binding matrix may be a glass fiber, etc. Numerous commercial providers of silica matrix are known like glass fiber filters. Such filters are of particularly known for use in the purification of nucleic acid molecules.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Wood a fiber glass filter paper. Doing so would allow for the purification and possible drying of the material as stated in Wood.
Ismagilov and Wood fail to teach “ and an aluminum foil,”.
Hirakata teaches (Para [222], During this process, the detector may be covered with an aluminum foil to remove He atoms that scatter along with the hydrogen atoms.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov and Wood to incorporate the teachings of Hirakata and an aluminum foil. Doing so would allow for the removal of atoms that would potentially interfere with a detection process as taught in Hirakata.
Ismagilov further teaches “, the fiber glass filter paper is sandwiched between the two first single-layer thermoplastic films and arranged on the aluminum foil, the two first single-layer thermoplastic films each has a hole, and the holes of the two first single-layer thermoplastic films are aligned, and the nanoparticles, or the nanoparticles and biomarkers in the nanoparticle-carrying liquid delivered through the holes of the two first single-layer thermoplastic films from the output hole of the reaction module are deposited on the fiber glass filter paper, and liquid filtered by the fiber glass filter paper flows out from a needle hole of the aluminum foil.” (Paras: [00305], [00315], [00415], [00416], and Claim 108, The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis. In particular examples, the layers are provided in a stacked configuration having a top layer, a bottom layer, and a plurality of intermediate layers. The intermediate layers can have one or more openings and/or capture regions such that various chambers and/or capture regions are able to be connected by relative movement. The devices of the invention can include one or more structural features, such as a substrate, a layer, a chamber (e.g., a well, a channel, a hole, a bridge, or a cavity, or any described herein), or a capture region. In any of the devices herein, samples, analytes, or solutions can be retrieved from a device by connecting a chamber or series of chambers to inlet/outlet holes. A subset of chambers can be aligned in order to form several paths. The integrated device is configured to detect at least one biological molecule). Therefore, the plurality of layers in a stacked configuration teaches to the claimed fiber glass filter paper sandwiched between the two first single layer thermoplastic films on the aluminum foil. The device having a detector which is previously disclosed which the device can include one or more structural features including a hole teaches to the claimed hole within the two first single-layer thermoplastic films. The chambers, having holes, that are aligned to form paths teaches to the claim that the holes of the within the two first single-layer thermoplastic films are aligned. The nanoparticles taught in Para [00348] and the biological molecule in addition to want was previously taught teaches to the nanoparticles and biomarkers in the nanoparticle-carrying liquid delivered through the holes to the layers form the output hole within the reaction module as claimed. Further, having the layers stacked with holes and the flow through chambers from inlet to outlet teaches to the foil layer in its claimed location having a hole which filtered liquid flows. Further, eMPEP 2144.04 section IV, A, states where if the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is patentably distinct from the prior art device. Therefore, having a “needle” hole within the aluminum foil layer as compared to a hole in the prior art is not patentably distinct.
However, Ismagilov does not explicitly teach “thermoplastic films” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic films because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic films in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Regarding Claim 9 Ismagilov in further teaches “wherein the aluminum foil is arranged with a needle hole that is not aligned with the holes of the two first single-layer thermoplastic films.” (Para [00234] and [00302], Fluid or reagent from a resistant unit or barrier unit can be flowed through or dispensed via a channel or other conduit. The geometric parameters (e.g. length, width, height, diameter) of a channel can be designed to control the operation time. For example, a longer channel or a narrower channel can be characterized by a larger hydrodynamic resistance and can increase the amount of time for a fluid or reagent to dispense from a resistant unit or barrier unit, and can therefore prevent a pushing unit from proceeding for a longer amount of time. The substrates or layers can include any useful material.) . Therefore, the ability of the geometric parameters of the channel in which the holes are arranged through can be designed differently to control the operation time. The holes are capable of not being aligned due to differing geometric parameters.
However, Ismagilov does not explicitly teach “thermoplastic films” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic films because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic films in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Regarding Claim 10 Modified Ismagilov teaches all of claim 7 as above in addition to teaching separation material with different parameters (Para [00236] and [00302] Systems and devices described herein can comprise filters, membranes, gels, and other separation materials. Parameters of a separation material can be chosen to provide a specific resistance to control the operation time. Parameters of a separation material can include thickness, porosity, and pore size of the material. The substrates or layers can include any useful material.). However, does not explicitly teach “wherein the dimensions of the fiber glass filter paper are smaller than the dimensions of the two first single-layer thermoplastic films” It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Ismagilov by having the dimensions of the fiber glass filter paper smaller that the dimensions of the two first single-layer thermoplastic films, since Ismagilov teaches to having parameters chosen to provide for set resistance control of the operation and having the fiber glass filter paper smaller would increase the filtration efficiency.
However, Ismagilov does not explicitly teach “thermoplastic films” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic films because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic films in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov, Wood, Qian, and Hirakata as applied to claim 7 above, and further in view of Unger et. al. (WO 2016074040), hereinafter Unger.
Regarding Claim 8 Ismagilov in further view of Wood, QIAN, and Hirakata teaches all of claim 7 in addition, (Para [00234] and [00302], Fluid or reagent from a resistant unit or barrier unit can be flowed through or dispensed via a channel or other conduit. The geometric parameters (e.g. length, width, height, diameter) of a channel can be designed to control the operation time. For example, a longer channel or a narrower channel can be characterized by a larger hydrodynamic resistance and can increase the amount of time for a fluid or reagent to dispense from a resistant unit or barrier unit, and can therefore prevent a pushing unit from proceeding for a longer amount of time. The substrates or layers can include any useful material.)
Ismagilov, Wood, QIAN, and Hirakata fail to explicitly teach “wherein the diameters of the holes of the two first single-layer thermoplastic films are equal, and are larger than the diameter of the output hole.”
Unger teaches (Page 4 lines 4-10, Preferably holes formed in one layer of the plurality of layers are aligned with holes in an adjacent layer so that a plurality of holes in a plurality of layers cooperate to form the micro channels. In some embodiments the holes decrease in diameter and increase in number from the first layer to the tissue-containing layer. The micro channels may have a varying cross-section along their length.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Unger wherein the diameters of the holes of the two first single-layer thermoplastic films are equal, and are larger than the diameter of the output hole. Doing so can control the operation time for the device as taught in Ismagilov in addition can decrease the probability of air bubbles as taught in Kamen et. al. (US 9492606 B2).
However, Ismagilov does not explicitly teach “thermoplastic films” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic films.
Claims 12, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov as applied to claim 11 above, and further in view of: Prow et. al. (EP 2838434 B1) machine translation, hereinafter Prow.
Regarding Claim 12 Ismagilov teaches all of claim 11 in addition, “ wherein the filtration module comprises a second single-layer thermoplastic film, a second thermoplastic film stack layer and a filter paper with medium retention, the filter paper with medium retention is sandwiched between the second single-layer thermoplastic film and the second thermoplastic film stack layer, the second thermoplastic film stack layer is in close contact with the reaction module, the second single-layer thermoplastic film has a first hole and the second thermoplastic film stack layer has a second hole, and the first hole of the second single-layer thermoplastic film is aligned with the second hole of the second (Paras:[00302], [00305], [00315], [00415]- [00416], [00297], and Claim 108, The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis. In particular examples, the layers are provided in a stacked configuration having a top layer, a bottom layer, and a plurality of intermediate layers. The intermediate layers can have one or more openings and/or capture regions such that various chambers and/or capture regions are able to be connected by relative movement. The devices of the invention can include one or more structural features, such as a substrate, a layer, a chamber (e.g., a well, a channel, a hole, a bridge, or a cavity, or any described herein), or a capture region. In any of the devices herein, samples, analytes, or solutions can be retrieved from a device by connecting a chamber or series of chambers to inlet/outlet holes. A subset of chambers can be aligned in order to form several paths. For any of the devices described herein, the membrane can be integrated into the device using any useful method. Exemplary methods include but are not limited to bonding using glues or adhesives, bonding using adhesive tapes, bonding using techniques commonly used for thermoplastic materials. The substrates or layers can include any useful material.). Therefore, the plurality of layers in a stacked configuration teaches to the claimed filter paper sandwiched between the two thermoplastic film layers. The device having holes and layers and connecting samples, analytes, or solutions to inlet/outlet holes teaches the claim that one of the layers could be in close contact with the reaction module and the holes thought the layers. The chambers, having holes, that are aligned to form paths teaches to the claim that the holes of the layers are aligned. The thermoplastic materials teach to the thermoplastic film.
Ismagilov fails to teach “filter paper with medium retention”.
Prow teaches (Page 4, In an embodiment of the microbiopsy device, the biological sample is a biological fluid, such as blood, plasma or serum. In this embodiment, the chamber may contain a biological fluid capturing element, such as an absorbent material, and the biological fluid soaks into the chamber (typically over a period of seconds). The absorbent material may comprise a fibrous material (e.g. filter paper). The fibrous material may be impregnated with chemicals that would lyse cells, denature proteins, and/or protect DNA/RNA. Examples of such a material may be FTA™ cards, polyethersulfone and Whatman (Grade 1) filter paper.) Therefore, the “Whatman (Grade 1) filter paper” teaches to the filter paper with medium retention.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Prow a layer could be grade 1 filter paper which is of medium retention. Doing so provides an absorbent material which would assist in the filtration process as it could absorb some of the unwanted components. In addition, it has the capability of impregnating with chemicals if needed to assist in the sample preparation as taught in Prow.
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Regarding Claim 13 Ismagilov in view of Prow teach all of claim 12 in addition Ismagilov teaches “wherein the second thermoplastic film stack layer is formed by stacking four or more single-layer thermoplastic film.” (Para [00302] and [00305] The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis. The substrates or layers can include any useful material.). In addition, eMPEP section 2144.04,VI, B: The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The plurality of layers within the device does not produce an unexpected result. Therefore, this lacks patentable significance.
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Regarding Claim 15 Ismagilov in view of Prow teach all of claim 12 in addition Ismagilov teaches “wherein the dimensions of the filter paper with medium retention are smaller than the dimensions of the second single-layer thermoplastic film of the filtration module, and smaller than the dimensions of the second thermoplastic film stack layer.” (Para [00236] and [00302], Systems and devices described herein can comprise filters, membranes, gels, and other separation materials. Parameters of a separation material can be chosen to provide a specific resistance to control the operation time. Parameters of a separation material can include thickness, porosity, and pore size of the material. The substrates or layers can include any useful material.)..
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
However, Ismagilov does not explicitly teach the relative dimensions of the layers or pores.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device Ismagilov to include the relative size of the layers or pores because Ismagilov teaches that changing the parameters of the layers such as thickness and pore size can provide the needed resistance to allow for a set operation time. The teaching, suggestion, or motivation in the prior art would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is obvious, see MPEP 2141 III (G).
Regarding Claim 14 Ismagilov teaches all of claim 5 in addition “, wherein the first thermoplastic film stacking layer is formed by stacking four or more single-layer thermoplastic films.” (Para [00305] The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis). In addition, eMPEP section 2144.04,VI, B: The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The plurality of layers within the device does not produce an unexpected result. Therefore, this lacks patentable significance.
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Claims 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov as applied to claim 11 above, and further in view of: Bransky et. al. (US 9592504 B2), hereinafter Bransky.
Regarding Claim 16 Modified Ismagilov teaches all of claim 12 in addition, “wherein the inlet module comprises a cap,” (Para[ 0021], [0065], and Fig 7H, the device further comprises a housing system surrounding the device having a through-hole that connects to at least one first chamber, wherein the housing system comprises an access port that connects to the through-hole for inserting a sample; and a cap for enclosing the housing system, wherein closing the cap results in introducing the sample into the through-hole or results in relatively moving the first substrate. FIG. 7H shows an exemplary schematic of a sample well and cap.) “a third thermoplastic film stack layer and a second substrate,” (Paras [00305], [00302], and [00393], The loading apparatus includes a rigid structure to create a magnitude controlled negative pressure. A gas impermeable sealant is applied between the layers of the device to create a closed cavity for the lubricant. The substrates or layers can include any useful material. The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis.) “the third thermoplastic film stack layer is arranged on the second substrate, the second substrate is in close contact with the second single-layer thermoplastic film, and the inlet module has a liquid channel” (Paras [00305] and [00387], dead-end filling can be employed for sample loading. In dead-end filling, a gap between two layers connects the main filling channels or chambers to the outlets. In this way, the filling liquid (e.g., a sample, a reagent, or any substance described herein) is confined in the channels or chambers. The layers are provided in a stacked configuration having a top layer, a bottom layer, and a plurality of intermediate layers. The intermediate layers can have one or more openings and/or capture regions such that various chambers and/or capture regions are able to be connected by relative movement.) “through which the liquid to be analyzed enters into the reaction module from the filtration module.” (as taught in claim 11).
Ismagilov does not teach “the cap is arranged on the third thermoplastic film stack layer,”
Bransky teaches (Abstract and Para [12], Abstract disposable cartridge may have a fluid analysis chip for receiving a fluid to be analyzed. The fluid analysis chip may be attached to a fluid preparation unit of the disposable cartridge and may include a base layer. The fluid analysis chip may also include a spacer layer disposed over the base layer, the spacer layer including a microchannel formed therein, the microchannel being configured to guide a flow of the fluid to be analyzed within the fluid analysis chip. The fluid analysis chip may also include a cap layer disposed over the spacer layer, the cap layer including an inlet and an outlet for establishing fluid communication with the microchannel included in the spacer layer. The spacer layer includes a microchannel formed therein. ) Therefore, the cap layer disposed over the spacer layer which includes is a microchannel teaches to the claimed cap on thermoplastic film stack layer because the thermoplastic film stack layer is part of the device in which the liquid travels through which could be defined as the microchannel.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Bransky to include the cap arranged on thermoplastic film stack layer. Doing so provide a location of the cap within the inlet to allow it to be on the layers which form the channel in which liquid flows through. This configuration would enable the sample to effectively travel to the liquid channel and allow the sample to be further introduced to other devices connected to it.
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Regarding Claim 17 Ismagilov in view of Bransky teaches all of claim 16 and Ismagilov further teaches “, wherein the cap is formed with a through hole, the third thermoplastic film stack layer is formed with a hole, and the second substrate is formed with a needle hole, and the liquid channel of the inlet module is formed with the through hole of the cap, the hole of the third thermoplastic film stack layer and the needle hole of the second substrate.” (Paras, [0021], [00302], [00305], [00315], [00415]- [00416], [00297], and Claim 108, In some embodiments of aspects provided herein, the device comprises a lid that encloses a cavity having volume and surrounds a through-hole in the device, wherein the through-hole connects to at least one first chamber. A housing system surrounding the device having a through-hole that connects to at least one first chamber, wherein the housing system comprises an access port that connects to the through-hole for inserting a sample; and a cap for enclosing the housing system, wherein closing the cap results in introducing the sample into the through-hole or results in relatively moving the first substrate. The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis. In particular examples, the layers are provided in a stacked configuration having a top layer, a bottom layer, and a plurality of intermediate layers. The intermediate layers can have one or more openings and/or capture regions such that various chambers and/or capture regions are able to be connected by relative movement. The devices of the invention can include one or more structural features, such as a substrate, a layer, a chamber (e.g., a well, a channel, a hole, a bridge, or a cavity, or any described herein). In any of the devices herein, samples, analytes, or solutions can be retrieved from a device by connecting a chamber or series of chambers to inlet/outlet holes. A subset of chambers can be aligned in order to form several paths. For any of the devices described herein, the membrane can be integrated into the device using any useful method. The substrates or layers can include any useful material.). The housing system comprising a through- hole, cap, chamber, and access port which is used for inserting a sample teaches to the cap formed with a through-hole and having it part of the liquid channel of the inlet module. The device having holes and layers and connecting samples, analytes, or solutions to inlet/outlet holes teaches thermoplastic film stack layer with hole and second substrate with needle hole. The chambers, having holes, that are aligned to form paths teaches to the claim of the liquid channel of the inlet module is formed with the through hole of the cap, the hole of thermoplastic film stack layer and the needle hole of the second substrate.
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Regarding Claim 18 Ismagilov teaches all of claim 17 in addition “, wherein the third thermoplastic film stack layer is formed by stacking eight or more single-layer thermoplastic film.” (Para [00305], The device can include multiple substrates of layers to accommodate multiplexed sample processing, preparation, and/or analysis). In addition, eMPEP section 2144.04,VI, B: The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The plurality of layers within the device does not produce an unexpected result. Therefore, this lacks patentable significance.
However, Ismagilov does not explicitly teach “thermoplastic film” but rather teaches (Para [00300], The substrates or layers can be formed from any useful material.)
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device to include thermoplastic film because Ismagilov teaches layers that can be formed from any useful material. A simple substitution of one known element for another to obtain predictable results is obvious, see MPEP 2141 III (B). Substituting a thermoplastic film in place of the film or a layer made of any material would still yield a flat wrapper film, which is capable of enclosing a predetermined location as taught in Ismagilov Para [00224].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov as applied to claim 1 above, and further in view of Kong et. al. (US 20150126388).
Regarding Claim 20 Ismagilov teaches all of claim 1 in addition to teaching conductive material being metal (Para [0021], and [00335], conductive material is phase change material, a metal) but does not explicitly teach “wherein the nanoparticles are silver nanoparticles.”.
Kong teaches a surface enhanced Raman spectroscopy (SERS) marker comprises a metallic nanoparticle in addition to, “wherein the nanoparticles are silver nanoparticles.” (Para [0005], silver nanoparticles).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ismagilov to incorporate the teachings of Kong wherein the nanoparticles are silver. Doing so provides nanoparticles that are antimicrobial and able to be made in different sizes and shapes which increase the versatility of the nanoparticles.
Response to Amendments
Information Disclosure Statement
The specification amendments have overcome the specification objection by removing the list of references within the specification.
Drawings
The drawing objection set forth in the non-final sent out on 7/2/2025 have been overcome due to amended Fig. 1 and Fig. 4 drawings.
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered.
Applicant request the rejections under 112 be withdrawn however it seems as though this should read 102 as no 112 rejections were made in the latest nonfinal dated 7/2/2025. The reason for the withdrawn to be requested was that Claim 1 now has an exclusive use of a single flow channel. Examiner acknowledges arguments but maintains that Ismagilov teaches a device as claimed in the “one” part of the one or more channels. Examiner also pointed this out in the nonfinal dated 7/2/2025.
Applicant argues that Ismagilov fails to teach or suggest several key limitations of claim 1 including the generation of nanoparticles via dissolution of dried chemical spots by the liquid to be analyzed., which enables superior SERS signal enhancement in malaria diagnosis. Examiner acknowledges arguments and maintains that the device of Ismagilov teaches to the generation of the nanoparticles in as much as positively claimed. Applicant must claim a specific structure to distinguish from the device of Ismagilov. Generation of nanoparticles, which is not reflected in a structural difference, is considered a statement of intended use, which is accorded no patentable weight in a claim to a device. Examiner also pointed this out in the nonfinal dated 7/2/2025.
Applicant argues that Ismagilov does not anticipate the recited features "the at least one chemical set is dissolved by the liquid to be analyzed and the dissolved chemical set carries out a chemical reaction to generate nanoparticles, and the liquid to be analyzed is mixed with the nanoparticles to obtain the nanoparticle-carrying liquid; wherein the at least one chemical set comprises a plurality of chemical reagents, each chemical reagent is arranged in the single flow channel in the form of dried chemical spots, and the dried chemical spots are arranged at intervals in sequence." and they are essential in enabling nanoparticle generation via dissolution by the analyzed liquid, providing unexpected advantages in signal strength, operational simplicity, and diagnostic accuracy that are not taught or suggested by Ismagilov. Examiner maintains that the recitation "the at least one chemical set is dissolved by the liquid to be analyzed and the dissolved chemical set carries out a chemical reaction to generate nanoparticles, and the liquid to be analyzed is mixed with the nanoparticles to obtain the nanoparticle-carrying liquid.” is capability of the device and Ismagilov teaches features which would allow for this capability. The recitation “wherein the at least one chemical set comprises a plurality of chemical reagents, each chemical reagent is arranged in the single flow channel in the form of dried chemical spots, and the dried chemical spots are arranged at intervals in sequence” is taught within Paras [0026], [00402], [00269], [0347], and [00348] as taught above. In addition, as stated above the one or more chambers teaches to a single chamber.
Applicant argues that claims 3-18 are dependent on claim 1 and should be allowed. Applicant also argues that claim 3 has a plurality of chemical sets which is not taught by Ismagilov. Examiner points out that Ismagilov teaches to the plurality of chemical sets within paras [00509], [00515], and [00348]. In addition, the duplication of chemical sets comprising a plurality of chemical sets is a duplication of parts which has no patentable significance as stated within claim 3 rejection.
Applicant submits that based on amendments claims are in condition for allowance. Examiner maintains the 102 and 103 rejection and added clarification for the claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/V.E.H./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798
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