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 .
Response to Amendment
The Amendment filed 12/17/2025 has been entered. Claims 1, 3, 4, 7, 8, 12, 15, 16, 18, 20, 21, 24, 25, 27, 29-34, 37, and 38 are pending in the application. Claims 33-34 are withdrawn. Claims 1, 3, 4, 7, 8, 12, 15, 16, 18, 20, 21, 24, 25, 27, 29-32, 37, and 38 are being examined herein.
Status of Objections and Rejections
The rejection under Double Patenting is being withdrawn in view of Applicant’s amendment.
New grounds for rejection under Double Patenting are necessitated by Applicant’s amendments.
The rejections 35 U.S.C. 112(b) are being withdrawn in view of Applicant’s amendment.
The rejections 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendment.
New grounds for rejection under 35 U.S.C. 103 are necessitated by Applicant’s amendments.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of copending Application No. 18/263,010 in view of Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) as evidenced by Mason et al (US 20090208548 A1).
Application 17/999,677 (instant)
Application 18/263,010 (claim set of 7/26/2023) (reference application)
Claim 1
Claim 13/12
A magnetofluidic cartridge, comprising:
A magnetofluidic cartridge, comprising:
a body structure that defines a channel and a plurality of wells disposed substantially within the body structure, wherein the channel is capable of fluidly communicating with the plurality of wells and wherein the plurality of wells comprises at least one sample inlet well and at least one sample analysis well
a top layer; a bottom layer spaced apart from the top layer in a generally parallel orientation with respect to the top layer, which bottom layer defines a plurality of wells that protrude from a surface of the bottom layer, wherein the plurality of wells comprises at least one sample inlet well and at least two sample analysis wells, which sample analysis wells are configured to undergo a set of tunable elution conditions; a space layer operably connected to the top and bottom layers; a channel defined by the top, bottom, and spacer layers, which channel is capable of fluidly communicating with the plurality of wells;
at least one port disposed through a top surface of the body structure at least proximal to the sample inlet well, which port fluidly communicates with the channel
at least one port disposed through the top layer and at least proximal to the sample inlet well, which port fluidly communicates with the channel;
a sealing mechanism operably connected, or connectable, to at least the top surface of the body structure and/or the port, which sealing mechanism seals the port when the sealing mechanism is in a closed position
a sealing mechanism operably connected, or connectable, to at least the top layer, which sealing mechanism seals the port when the sealing mechanism is in a closed position;
a plurality of magnetic particles disposed in at least the sample inlet well
a plurality of magnetic particles disposed in at least the sample inlet well;
at least one processing reagent disposed in at least the sample analysis well and/or in at least one other chamber that fluidly communicates with the sample analysis well
processing reagents disposed in each of the sample analysis wells.
a first temperature sensitive material disposed in a substantially solid state in the channel between the sample inlet well and the sample analysis well and/or at least partially within the sample inlet well and/or the sample analysis well, which first temperature sensitive material fluidly partitions the sample inlet well and the sample analysis well from one another when the first temperature sensitive material is in the substantially solid state
a first temperature sensitive material disposed in a substantially solid state in the channel between the sample inlet well and the sample analysis wells, which first temperature sensitive material fluidly partitions the sample inlet well and the sample analysis wells from one another when the first temperature sensitive material is in the substantially solid state to produce a first region that comprises the sample inlet well and at least a first portion of the channel and a second region that comprises the sample analysis wells and at least a second portion of the channel
a sealing fluid disposed in at least a portion of the channel, which sealing fluid is immiscible with at least the plurality of magnetic particles and with the processing reagent.
a sealing fluid disposed at least in the second portion of the channel of the second region, which sealing fluid is immiscible with the processing reagents such that the processing reagents are substantially contained within the sample analysis wells
Claim 13 of co-pending Application 18/263,010 does not claim wherein the first temperature sensitive material and the sealing fluid differ from one another, and wherein the first temperature sensitive material is less dense than at least the plurality of magnetic particles, the sealing fluid, a sample and assay reagents.
However, Kelso teaches fluidic cartridge with lipophilic material for biological sample analysis. Kelso further teaches the cartridge can be made of polypropylene (para. 0179) and the lipophilic material (sealing fluid) can be silicone oil (para. 0105).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of plurality wells and the sealing fluid claimed by ‘010 to be polypropylene and silicone oil because one of ordinary skill in the art would accordingly have recognized the polypropylene would result in the predictable result of providing suitable material for the cartridge well and the sealing fluid.
The teachings of modified Kelso would yield wherein the first temperature sensitive material (the wall between two wells, which is made of polypropylene) and the sealing fluid (silicone) differ from one another, and wherein the first temperature sensitive material (polypropylene) is less dense than at least the plurality of magnetic particles, the sealing fluid (silicone oil), a sample and assay reagents (Table 3 of Kelso, polypropylene has a density of is a 0.8994 g/m3; para. 0206 of Kelso, magnetic particles has a density of 5 g/mL; Mason, para. 0082, silicone oil has a density of 0.973 g/mL, and aqueous reagents and sample have a density of ~1 g/mL).
This is a provisional nonstatutory double patenting rejection.
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.
Claims 1, 3, 4, 7, 8, 12, 15, 16, 24, 25, 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) as evidenced by Mason et al (US 20090208548 A1).
Regarding claim 1, Kelso teaches a magnetofluidic cartridge (Fig. 1, Example 1), comprising:
a body structure (the structure shown in 1. Para. 105 teaches the structure includes top plate, a wax channel layer with adhesive on both sides, chamber layer made from clear round bottom 96-well plate) that defines a channel (wax channel, para. 0150)(Although Fig. 4 illustrate another example cartridge, based on para. 0149 – 0151, the examiner interprets the layer configuration of the top plate, adhesive tape, wax channel and chambers illustrates in Fig. 4 represents that of Example 1) and a plurality of wells (chambers 1 to 6)(para. 0164) disposed substantially within the body structure (Figs. 1 and 2), wherein the channel is capable of fluidly communicating with the plurality of wells (para. 0164 and Fig. 2) and wherein the plurality of wells comprises at least one sample inlet well (chamber 1) and at least one sample analysis well (chamber 6);
at least one port (holes punched on top plate, para. 0150) disposed through a top surface of the body structure at least proximal to the sample inlet well, which port fluidly communicates with the channel (para. 0150);
a plurality of magnetic particles (paramagnetic micro particles, para. 0148) disposed in at least the sample inlet well (para. 0164);
at least one processing reagent (elution buffer)(Fig. 1) disposed in at least the sample analysis well and/or in at least one other chamber that fluidly communicates with the sample analysis well (para. 0164);
a first temperature sensitive material (the chamber wall between chambers 1 and 2, which is made of polystyrene. Like all materials, polystyrene is temperature sensitive) disposed in a substantially solid state (the chamber wall is in a substantially solid state) in the channel between the sample inlet well (chamber 1) and the sample analysis well (chamber 6)
a sealing fluid (the liquid wax); disposed in at least a portion of the channel, which sealing fluid is immiscible with at least the plurality of magnetic particles and with the processing reagent (elution buffer)(paras. 0100 and 0107, lipophilic material is immiscible with the reagent, which includes the elution buffer).
wherein the first temperature sensitive material (chamber wall between 1 and 2) and the sealing fluid (liquid wax) differ from one another (polystyrene vs. liquid wax).
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Figure A. annotated fig. 2 of Kelso.
Kelso fails to explicitly teach a sealing mechanism operably connected, or connectable, to at least the top surface of the body structure and/or the port, which sealing mechanism seals the port when the sealing mechanism is in a closed position;
However, Kelso teaches, in Example 2, a peelable layer disposed between the top plate and the wax channel layer in order to provide a vapor barrier optimum for long term storage. The peelable is removed before the test (para. 0185).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the cartridge of Example 1 taught by Kelso, to include a peelable layer between the top plate the wax channel layer in order to provide a vapor barrier optimum for long term storage with a reasonable expectation of success (Kelso, para. 0185) (MPEP 2143)(I)(G).
The teachings of Example 1 of Kelso as modified by Example 2 would yield a sealing mechanism (peelable layer) operably connected, or connectable, to at least the top surface of the body structure and/or the port (peelable is connected to the top plate), which sealing mechanism seals the port when the sealing mechanism is in a closed position (para. 0185, the peelable layer seals the cartridge before use).
In addition, Kelso teaches in Example 1 that the cartridge is made polystyrene (para. 0150) and liquid wax is used as the lipophilic material for separating reagents between chambers, and thus fails to teach and thus fails to teach wherein the first temperature sensitive material is less dense than at least the plurality of magnetic particles, the sealing fluid, a sample and assay reagents (sample and assay reagents are not positively recited).
However, Kelso teaches polystyrene and polypropylene are both choice material for carrying out chemical assay (para. 0179) and Kelso teaches in another embodiment a vacuum formed chamber made out of polypropylene or polystyrene similar to a 96 well plate is used (para. 0183). Additionally, Kelso teaches the lipophilic material (sealing fluid) can be a liquid wax or a silicone oil (paras. 0103 and 0105).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cartridge material of polystyrene and the lipophilic material of liquid wax taught by Kelso in Example 1 with polypropylene as the cartridge material and silicone oil as the lipophilic material because one of ordinary skill in the art would accordingly have recognized whether polystyrene or polypropylene would result in the predictable result of providing a choice material for cartridge (para. 0179) and whether liquid wax or silicone oil would result in the predictable result of providing a lipophilic material for separating reagents between chambers (para. 0103, 0105).
The teachings of modified Kelso would yield wherein the first temperature sensitive material (polypropylene) is less dense than at least the plurality of magnetic particles, the sealing fluid (silicone oil), a sample and assay reagents (Table 3, polypropylene has a density of is a 0.8994 g/m3, which is lower than the density of magnetic particles of 5 g/mL as states in para. 0206. Silicone oil has a density of 0.973 g/mL as evidenced by Mason, para. 0082. Tris-EDTA elution buffer reagent and sample, which is not positively recited but is typically aqueous based, have a density of ~1.0 g/mL).
Regarding claim 3, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Kelso further teaches wherein the plurality of wells further comprises at least one overflow reservoir (chamber 2) that is structured to receive excess sample (Fig. 2), when the sample is received in the sample inlet well (chamber 1) through the port (interpreted as an intended use. The sample is not positively recited. Chamber 2 is structurally capable of receiving excess sample).
Regarding claim 4, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Kelso further teaches the magnetofluidic cartridge further comprising at least one vent orifice (the top opening another one of the punched holes)(para. 0105) disposed through at least a portion of the body structure or through at least one layer (top plate), which vent orifice fluidly communicates with the channel (wax channel)(para. 0150 and 0162, fluid can be introduced into the cartridge through punched holes, and thus the vent fluidly communicates with the wax channel) and is structured to vent one or more gases from the channel at least when the magnetofluidic cartridge is heated (interpreted as an intended use. The tiny hole meet the structural limitation of the intended use).
Regarding claim 7, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Kelso further teaches wherein the first temperature sensitive material (chamber wall between chambers 1 and 2, which is polypropylene in modified Kelso) fluidly partitions the sample inlet well (chamber 1) and the sample analysis well (chamber 6) from one another when the first temperature sensitive material is in the substantially solid state to produce a first region (see annotated Fig. B below) that comprises the sample inlet well and at least a first portion of the channel (the portion of the wax channel immediately above chamber 1) and a second region that comprises the sample analysis well (chamber 6) and at least a second portion of the channel (the portion of channel extends from portion of channel from chamber 2 to chamber 6), and wherein the sealing fluid (the silicone oil) is disposed at least in the second portion of the channel of the second region such that the processing reagent (elution buffer in chamber 6) is substantially contained within the sample analysis well (Fig. 2, elution buffer is in chamber 6) (see Fig. B).
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Figure B. annotated fig. 2 of Kelso.
Regarding claim 8, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Kelso further teaches wherein the first temperature sensitive material (chamber wall between chambers 1 and 2, which is polypropylene in modified Kelso) is insoluble in aqueous materials (polypropylene is insoluble in aqueous materials); in the substantially solid state at a temperature less than about 40 oC; and/or in at least a partially fluid state at a temperature more than about 40 oC (polypropylene is in solid state at a temperature less than 40 oC).
Regarding claim 12, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Kelso further teaches wherein the sealing fluid (silicone oil) is a hydrophobic fluid (paras. 0039, 0105, silicone oil is immiscible in aqueous fluid).
Regarding claim 15, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Kelso further teaches wherein the plurality of magnetic particles comprises coated magnetic nanoparticles that are coated with silica and/or a coating material that electrostatically binds nucleic acids (para. 0159).
Regarding claim 16, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Kelso fail to explicitly teach the thickness of the wall of the plurality of wells, and thus fails to teach wherein at least one of the plurality of wells comprises a wall thickness of 0.05 mm to 0.5.
However, Kelso teaches in Example 2 of fabricating cartridge chamber using foil laminate. Kelso teaches that foil laminate provides excellent vapor barrier for reagent during storage. Kelso further teaches the thickness of the foil is 3.5 mil (Table 3) which is 0.089 mm.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the chamber, polypropylene, taught in Example 1 of modified Kelso to be foil as taught by Example 2 of Kelso in order to provides excellent vapor barrier for reagent during storage with a reasonable expectation of success (Kelso, para. 0181) (MPEP 2143)(I)(G).
The teachings of Example 1 in modified Kelso as modified by Example 2 in Kelso would yield the thickness of the wall of the plurality of wells to be 0.089 mm, which is within the range of 0.05 to 0.5 mm.
Regarding claim 24, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Kelso further teaches wherein the sealing fluid comprises a silicone oil (see claim 1).
Regarding claim 25, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Kelso further wherein the plurality of magnetic particles is in a dried state (para. 0170, the magnetic particle is in a dried state as evidence by drying step is unnecessary and fluid being carried from one chamber to the next is minimal).
Regarding claim 29, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Kelso further teaches the magnetofluidic cartridge further comprising at least one sample (plasma sample) comprising at least one biomolecule (armored RNA) disposed in the sample inlet well (para. 0161).
Regarding claim 30, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 29. Kelso further teaches wherein the biomolecule comprises at least one nucleic acid
Regarding claim 31, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. Kelso further teaches the magnetofluidic cartridge further comprising at least one buffer, at least one salt, and/or at least one lytic reagent disposed in the sample inlet well and/or in the other chamber (Fig. 1).
Regarding claim 32, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1. The limitation “packaged as a component of a kit” is interpreted as an intended use. The invention of claim meets the structural limitation of the intended use.
Claims 18 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) in view of Anderson et al. (US 20050202504 A1).
Regarding claim 18, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1.
Kelso teaches methods for producing cartridges for nucleic acid purification and PCR that are conducive to reagent storage and transport (paras. 0097).
Kelso teaches in Example 1 that elution buffer (processing reagent) is in liquid form (para. 0164) and thus fails to teach wherein the processing reagent is lyophilized.
However, Anderson teaches a microfluidic device in the field of nucleic acid diagnostics for sample extraction, PCR amplification, nucleic acid fragmentation and labeling, extension reactions, transcription reactions and the like (para. 0077). Anderson further teaches reagents may introduced to the sample in either liquid or lyophilized form (para. 0082). Anderson further teaches where the various reagents are predisposed within the amplification or adjacent chamber, it will often be desirable for these reagents to be in lyophilized forms, to provide maximum shelf life of the overall device (para. 0103).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processing reagent taught by Kelso to be in lyophilized form in order to maximize the shelf life of the device with a reasonable expectation of success (Anderson, para. 0103) (MPEP 2143)(I)(G).
Regarding claim 27, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 1.
Kelso fails to explicitly teach in Example 1 that the magnetofluidic cartridge further comprising at least one control reagent disposed in at least the sample inlet well and/or in at least the other chamber, which control reagent is in a dried state.
However, Kelso teaches the necessity of control reagents in performing purification and analysis using the cartridges (Paras. 0145-0146) and the internal control reagents can pre-loaded into the device or provided in the form of a kit (paras. 0092 and 0145-0146).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge in Example 1 taught by Kelso with control reagents disposed in a chamber (pre-loaded into the device) as taught by Kelso in para. 92, 0145-0146 in order to have an internal control for purification and analysis with a reasonable expectation of success (para. 0146) (MPEP 2143)(I)(G).
In addition, Anderson teaches a microfluidic device in the field of nucleic acid diagnostics for sample extraction, PCR amplification, nucleic acid fragmentation and labeling, extension reactions, transcription reactions and the like (para. 0077). Anderson further teaches reagents may introduced to the sample in either liquid or lyophilized (freeze-dried) form (para. 0082). Anderson further teaches where the various reagents are predisposed within the amplification or adjacent chamber, it will often be desirable for these reagents to be in lyophilized forms, to provide maximum shelf life of the overall device (para. 0103).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control reagent taught by modified Kelso to be in lyophilized (freeze-dried) form in order to maximize the shelf life of the device with a reasonable expectation of success (Anderson, para. 0103) (MPEP 2143)(I)(G).
The teachings of modified Kelso as modified by Anderson would yield the magnetofluidic cartridge further comprising at least one control reagent disposed in at least the sample inlet well and/or in at least the other chamber, which control reagent is in a dried state (lyophilized).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) in view of Kosak et al. (US5413924A).
Regarding claim 20, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 7.
Kelso teaches producing cartridges for nucleic acid purification and/or analysis (para. 0009). Kelso in Example 1 teaches a cartridge for purification of nucleic acid.
Kelso fails to teach the magnetofluidic cartridge comprising a second temperature sensitive material disposed in a substantially solid state at least proximal to the sample analysis well (chamber 6), which second temperature sensitive material fluidly partitions the processing reagent disposed in the sample analysis well and the sealing fluid (liquid wax between chambers 5-6) disposed in a second portion of the channel of a second region from one another when the second temperature sensitive material is in the substantially solid state.
However, Kelso further teaches the purified RNA in Example 1 is ready for amplification and analysis (para. 0096). Kelso further teaches in Example 3 a device employing the lipophilic barrier for nucleic acid analysis (para. 0219). Kelso teaches in the device in example 3 include all the necessary assay reagents including wash buffers (para. 0129).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample analysis well (chamber 6) in Example 1 to include addition chambers, each comprises an assay reagent including wash buffers taught by Example 3 and covered by sealing fluid as taught by Example 1 in order to for the cartridge to perform both purification and analysis with a reasonable expectation of success (Kelso, para. 0009) (MPEP 2143)(I)(G).
In addition, Kosak teaches preparation of wax beads that entrap reagents within, such that the reagents are heat-releasable (abstract). Kosak teaches the wax beads have application in nucleic acid amplification and analysis (abstract). Kosak teaches teaches the wax beads can be stored in wells of a cartridge (Fig. 6). Kosak further teaches the wax beads allows for controlled-release of reagents by heating (abstract) and also protection reagent degradation during storage (col. 3, lns. 4-5).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processing reagents and assay reagents in the sample analysis well (modified chamber 6 with multiple chambers) taught by modified Kelso to have the reagents entrapped in wax beads as taught by Kosak in order to have an additional mechanism to control sample-reagent interaction through heat-controlled-release of reagent of the wax beads as well as protection of reagent degradation during storage with a reasonable expectation of success (Kosak) (MPEP 2143)(I)(G).
The teachings of modified Kelso would yield the magnetofluidic cartridge comprising a second temperature sensitive material (wax beads taught by Kosak) disposed in a substantially solid state at least proximal to the sample analysis well (modified chamber 6 that includes multiple chambers)(wax beads containing reagent is stored in the chambers in modified chamber 6), which second temperature sensitive material fluidly partitions the processing reagent (elution buffer) disposed in the sample analysis well and the sealing fluid (silicone oil) disposed in a second portion of the channel of a second region from one another when the second temperature sensitive material is in the substantially solid state (processing and assay reagents are entrapped in the wax bead are in individual chambers of modified chamber 6, and thus fluidly separated from the processing reagent and the silicone oil).
Regarding claim 21, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 20. Modified Kelso further the magnetofluidic cartridge further comprising at least one reconstitution buffer (wash buffers)(in modified Kelso, assay reagents includes wash buffers) disposed in the sample analysis well, wherein the second temperature sensitive material (wax beads) separates the reconstitution buffer from the processing reagent (reconstitution buffer is encapsulated in a wax bead in a chamber of modified chamber 6).
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) in view of Atkin et al. (US 20090165876 A1)
Regarding claim 37, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 4.
Kelso teaches cartridge comprises punched holes in the top late for introduction of fluids into the cartridge (para. 0162).
Modified Kelso fails to teach the cartridge further comprising at least one filter disposed at least proximal to the vent orifice (the top opening of one of the punched holes), which filter is structured to substantially prevent leakage of fluidic material from the channel through the vent orifice.
However, Atkin teaches a cartridge comprise an inlet, which comprises a filter (semi-permeable membrane 68A)(Fig. 15a) to filter the fluid (para.0169) as the fluid being introduced through the inlet. Atkin further teaches the inlet can also be configured as a vent (para. 0169).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the punched holes taught by Kelso to include a filter as taught by Atkin in order to filter fluid that is introduced to the cartridge with a reasonable expectation of success (Atkin, para. 0169) (MPEP 2143)(I)(G).
The teachings of modified Kelso would yield the cartridge further comprising at least one filter (semi-permeable membrane) disposed at least proximal to the vent orifice (the top opening of one of the punched holes)(membrane is disposed in the hole), which filter is structured to substantially prevent leakage of fluidic material from the channel through the vent orifice (interpreted as an intended use. the filter meets the structural limitation of the intended use).
Regarding claim 38, modified Kelso teaches all of the elements of the current invention as stated above with respect to claim 37. Modified Kelso further teaches, wherein the vent orifice (the top opening of one of the punched holes) and the channel fluidly communicate with one another via at least one vent channel (the channel between the two openings of the tiny hole. The hole has a thickness, and the thickness is the length of the channel)(the tiny holes are in fluidic communication with the wax channel).
Response to Arguments
Applicant’s arguments, see pp. 10-13, filed 12/17/2025, with respect to the rejections under 35 U.S.C 112 have been fully considered. The arguments, with exception of the argument relating to the “Alternative interpretation” on p. 13, are persuasive.
In regards to the arguments relating to the “Alternative interpretation,” the Applicant respectfully argues that the alternative interpretation would render the device inoperative, because if the polystyrene chamber wall were “liquified under an applied temperature change, the contents of chambers 1 and 2 would mix with one another, if not leak from the device itself.” Furthermore the Applicant argues that under that “Alternative interpretation,” Kelso fails to teach or suggest various other features of the pending claims, including those recited in, for example, claims 7, 20, 37, and 38.
The examiner respectfully disagrees. It first notes that the claims do not recite any applied temperature change to the “first temperature sensitive material.” Claim 1 requires “the first temperature sensitive material” to be in a substantially solid state, and claim 8 further limits the first temperature sensitive material in the substantially solid state at a temperature less than about 40 °C; and/or in at least a partially fluid state at a temperature more than about 40 °C.” Theses limitations and other limitations relating to the first temperature sensitive material are met by the wall between chamber 1 and 2, which is made of polystyrene or polypropylene, as discussed above in the 35 U.S.C. 103 section. The Applicant’s argument appears to be referring the description in the specification. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, "a claim containing a 'recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus' if the prior art apparatus teaches all the structural limitations of the claim" (MPEP 2114 II).
Therefore, this argument is unpersuasive.
In regard to “Kelso fails to teach or suggest various other features of the pending claims, including those recited in, for example, claims 7, 20, 37, and 38,” the Applicant does not point out any specific supposed error of the previous Office Action. Therefore this argument is unpersuasive.
Applicant’s arguments, see pp. 13, filed 12/17/2025, with respect to the provisional rejection under Double Patenting have been fully considered and are persuasive. Therefore, the provisional rejection of 09/19/2025 have been withdrawn. However, upon further consideration, a new ground(s) of provisional rejection is necessitated by the 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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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758