DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/05/2026 has been entered.
Response to Amendment
The Amendment filed 08/05/2026 has been entered. Claims 1, 3, 4, 7, 8, 12, 15-16, 18, 20-21, 24-25, 27 29-34 and 37-38 are pending in the application. Claims 33 and 34 are withdrawn. Claims 1, 3, 4, 7, 8, 12, 15-16, 18, 20-21, 24-25, 27 29-32 and 37-38 are being examined herein.
Status of Objections and Rejections
The provisional non-statutory double patenting rejection over claim 13 of copending Application No. 18/263,010 is being withdrawn because that status of the application has been changed to granted and claim 13 has been canceled.
The rejection of under 35 USC 103 is withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
claim 1, line 21, “and,” should read “and”
claim 8, lines 3 and 4, “40 ?C” should read “40 oC”.
Appropriate correction is required.
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, 7-8, 12, 15-16, 24-25 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (“Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation” Sci Rep 8, 9793; 2018) in view of Song et al. (“A Multifunctional Reactor with Dry-Stored Reagents for Enzymatic Amplification of Nucleic Acids“ Anal. Chem. (2018) 90 (2): 1209–1216) as evidenced by Schaller et al. (US 20120003523) and Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024), and Mason et al. (US 20090208548 A1).
Regarding claim 1, Shin teaches a magnetofluidic cartridge (Fig. 2a-c), comprising:
a body structure (cartridge, Fig. 2a) that defines a channel (fluid path above the wells, Fig. 2c) and a plurality of wells (4 wells, Fig. 2b) 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 (binding buffer well) and at least one sample analysis well (PCR buffer well);
at least one port (opening/port)(Fig. 2b caption and “Cartridge design”) disposed through a top surface of the body structure at least proximal to the sample inlet well (binding buffer well), which port fluidly communicates with the channel (Fig. 2b and “Cartridge design”);
a sealing mechanism (pressure sensitive adhesive) 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 (Fig. 2a caption, leak-proof seal);
a plurality of magnetic particles disposed in at least the sample inlet well (Fig. 2b caption);
at least one processing reagent (one of the PCR reagents in the PCR solution) disposed in at least the sample analysis well (PCR buffer well)
a sealing fluid (silicone oil) disposed in at least a portion of the channel (Fig. 2a caption), which sealing fluid is immiscible with at least the plurality of magnetic particles and with the processing reagent;
Shin teaches a fluidic cartridge for PCR analysis (abstract). Shin teaches the PCR reagents are stored in the cartridge in a solution form in the PCR buffer well (Fig. 2b), and therefore fails to teach 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, wherein the first temperature sensitive material is distinct from the body structure and is capable of transitioning from the substantially solid state to a fluid state upon heating to permit fluid communication between the sample inlet well and the sample analysis well through the channel; 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 such that, upon transitioning to the fluid state, the first temperature sensitive material floats relative to the sealing fluid and is displaceable from the channel.
However, Shin teaches encapsulation of PCR reagent in wax can enable long term use of the cartridge that is more conducive for the cartridge to be used in a point-of-care POC setting (Shin, p. 8, 5th para.). In addition, Song teaches a PCR fluidic cartridge with paraffin-encapsulating PCR reagent stored within for POC applications (Song, abstract and Fig. 1). Song teaches the PCR reagents are lyophilized, and then encapsulated in paraffin in a well in the cartridge (Fig. 1).
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 PCR solution in the PCR buffer taught by Shin by encapsulating lyophilized PCR reagents in paraffin in the well as taught by Song in order to enable long term storage of PCR reagents in the cartridge for PCR applications (Shin, p.8, “Discussion and Conclusion; Song, abstract) with a reasonable expectation of success. (MPEP 2143)(I)(G).
The teachings of Shin as modified with Song would yield a first temperature sensitive material (paraffin) disposed in a substantially solid state
wherein the first temperature sensitive material is distinct from the body structure (paraffin is distinct from the body structure) and is capable of transitioning from the substantially solid state to a fluid state upon heating to permit fluid communication between the sample inlet well and the sample analysis well through the channel (Song, Fig. 1B and corresponding caption);
wherein the first temperature sensitive material and the sealing fluid differ from one another (paraffin vs. silicone oil), and wherein the first temperature sensitive material (paraffin) is less dense than at least the plurality of magnetic particles, the sealing fluid, a sample and assay reagents (Schaller, Table 1, paraffin has a density of is a 0.770 g/mL (liquid) and 0.88 g/mL (solid); Kelso, para. 0206, density of magnetic particles is 5 g/mL; and Mason, para. 0082, silicone oil has a density of 0.973 g/mL, 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) such that, upon transitioning to the fluid state, the first temperature sensitive material floats relative to the sealing fluid and is displaceable from the channel (encompassed by the preceding limitation that the first temperature sensitive material is less dense; moreover, Song, Fig.1 caption, as the chip is heater, molten paraffin floats up and way).
Regarding claim 3, modified Shin 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 (one of the wash buffer wells) that is structured to receive excess sample (Fig. 2), when the sample is received in the sample inlet well (binding buffer well) through the port (interpreted as an intended use. The sample is not positively recited. One of the binding buffer well is structurally capable of receiving excess sample).
Regarding claim 7, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Shin further teaches wherein the first temperature sensitive material (paraffin) fluidly partitions the sample inlet well (binding buffer well) and the sample analysis well (PCR buffer well) from one another when the first temperature sensitive material is in the substantially solid state to produce a first region (see annotated Fig. A below) that comprises the sample inlet well and at least a first portion of the channel (the portion of the channel immediately above the binding buffer well) and a second region that comprises the sample analysis well (PCR buffer well, which is filled with paraffin that encapsulates the dry PCR reagent, Song, Fig. 1) and at least a second portion of the channel (the portion of channel immediately above the PCF buffer well), 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 (PCR reagent) is substantially contained within the sample analysis well (Shin, Fig. 2b caption and Song, Fig. 1).
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Figure A. annotated fig. 2a of Shin.
Regarding claim 8, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Shin further teaches wherein the first temperature sensitive material (paraffin) 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 (paraffin’s melting temperature is 35 oC, which is about 40 oC).
Regarding claim 12, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Shin further teaches wherein the sealing fluid (silicone oil) is a hydrophobic fluid (silicone oil is a hydrophobic fluid).
Regarding claim 15, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Shin 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 (Fig. 2b and the corresponding caption).
Regarding claim 16, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Shin further teaches wherein at least one of the plurality of wells comprises a wall thickness of between about 0.05 mm and about 0.5 mm (p. 9, “Design and fabrication of thermoplastic cartridge body), well thickness is 0.2 mm).
Regarding claim 18, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Shin further teaches wherein the processing reagent is lyophilized (Song, “Experimental Section”, all reagents were lyophilized).
Regarding claim 24, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Shin further teaches wherein the sealing fluid comprises a silicone oil (Fig. 2a caption).
Regarding claim 25, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Shin further wherein the plurality of magnetic particles is in a dried state (Fig. 2 caption, the magnetic particle is in a dried state when it is passing through the silicone oil).
Regarding claim 29, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Shin further teaches the magnetofluidic cartridge further comprising at least one sample (sample of interest) comprising at least one biomolecule (nucleic acid) disposed in the sample inlet well (Fig. 2b caption).
Regarding claim 30, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 29. Shin further teaches wherein the biomolecule comprises at least one nucleic acid
Regarding claim 31, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1. Shin 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. 2, wash buffer).
Regarding claim 32, modified Shin 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (“Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation” Sci Rep 8, 9793; 2018) in view of Song et al. (“A Multifunctional Reactor with Dry-Stored Reagents for Enzymatic Amplification of Nucleic Acids“ Anal. Chem. (2018) 90 (2): 1209–1216) as evidenced by Schaller et al. (US 20120003523) and Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) and Mason et al. (US 20090208548 A1) applied to claim 1, and further in view of Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024).
Regarding claim 4, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1.
Shin teaches a magnetofluidic cartridge for PCR analysis. Shin teaches a body structure that defines a channel and one port/opening disposed through a top surface of the body structure for the fluid to be introduced into the cartridge (Fig. 2b caption). Modified Shin teaches only one port/opening, and thus fail to teach the cartridge further comprising at least one vent orifice disposed through at least a portion of the body structure or through at least one layer, which vent orifice fluidly communicates with the channel and is structured to vent one or more gases from the channel at least when the magnetofluidic cartridge is heated.
However, Kelso further teaches a magnetofluidic cartridge for PCR. Kelso teaches the cartridge comprises a body structure (the structure shown in 1. Para. 0105, 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 and a plurality of ports/openings (punched holes, para. 0150 and 165) disposed through a top surface (top plate) of the body structure for introduction of fluid (paras. 0150 and 0165)
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 top surface taught by modified Shin to include one or more additional openings through the top surface for introduction of fluid as taught by Kelso in order to provide additional fluid introduction access, and the claimed limitations are obvious because all the claimed elements (a port/opening and additional ports/openings) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination yielded nothing more than predictable results (means for fluid introduction). See MPEP 2143(I)(A).
The teaching of modified Shin would at least one vent orifice (the top opening of one of the additional holes as taught by Kelso, para. 0150) disposed through at least a portion of the body structure or through at least one layer (Kelso, para. 0150 and Shin, Fig. 2b caption), which vent orifice fluidly communicates with the channel (Kelso, para. 0150 and 0162 and Shin, Fig. 2b caption) 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 holes/openings/ports meet the structural limitation of the intended use).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (“Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation” Sci Rep 8, 9793; 2018) in view of Song et al. (“A Multifunctional Reactor with Dry-Stored Reagents for Enzymatic Amplification of Nucleic Acids“ Anal. Chem. (2018) 90 (2): 1209–1216) as evidenced by Schaller et al. (US 20120003523) and Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024), and Mason et al. (US 20090208548 A1) as applied to claim 7, and further in view of Naegele et al. (US 6428962 B1).
Regarding claim 20, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 7.
Shin teaches a magnetofluidic cartridge for nucleic acid isolation and PCR analysis (abstract, Fig. 2b). Shin teaches the cartridge comprises a plurality of wells, the sample enters through the sample inlet well for nucleic acid isolation, and subsequently the isolated nucleic acid guided by magnetic beads travels through wash buffer wells for removal of undesired components and arrives at the sample analysis well to react with the PCR reagents in the sample analysis well (Fig. 2 and captions). Modified Shin teaches the PCR reagents is lyophilized and encapsulated in paraffin wax (Song, Fig. 1) in the sample analysis well. Modified Shin teaches all the reagent are encapsulated together and thus 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, which second temperature sensitive material fluidly partitions the processing reagent disposed in the sample analysis well and the sealing fluid 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, Naegele teaches segregation of PCR reagents minimizes undesirable primer annealing and to extend reagent stability (col. 2, ln. 35-43). Naegele further teaches the use of a plurality wax barriers to segregate the reagents (Fig. 3, wax barriers 30, 60 and reagents 40 and 70; col. 5, lns. 5-10).
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 encapsulation of all the PCR reagents together (Song, Fig. 1, a layer of paraffin encapsulated all dried PCR reagents beneath) as taught by modified Shin to encapsulation of the reagents separately and segregated the reagents by barriers (multiple layers of paraffin with each layer encapsulating a separate PCR reagent) as taught Naegele in order to minimizes undesirable primer annealing and to extend the period of reagent stability (col. 2, ln. 35-43) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of modified Shin would yield the magnetofluidic cartridge comprising a second temperature sensitive material (a second wax/paraffin barrier/layer that is above the first barrier/layer which encapsulates the processing reagent)(Song, Fig. 1, a wax layer encapsulating reagents; in modified Shin, a plurality of wax layers each encapsulating a reagent as illustrated in Naegele Fig. 3) disposed in a substantially solid state at least proximal to the sample analysis well, which second temperature sensitive material fluidly partitions the processing reagent (one of the PCR reagents) 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 (Shin, Fig. 2b caption, Song, Fig. 1 and Naegele, Fig. 3).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (“Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation” Sci Rep 8, 9793; 2018) in view of Song et al. (“A Multifunctional Reactor with Dry-Stored Reagents for Enzymatic Amplification of Nucleic Acids“ Anal. Chem. (2018) 90 (2): 1209–1216) as evidenced by Schaller et al. (US 20120003523) and Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) and Mason et al. (US 20090208548 A1) applied to claim 1, and further in view of Anderson et al. (US 20050202504 A1).
Regarding claim 27, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 1.
Shin teaches a magnetofluidic cartridge for nucleic acid isolation and PCR analysis that can potentially be used in point of care applications of testing blood samples. Shin uses clinically obtained serum rather than whole blood samples for a proof-of-concept study in a laboratory setting and thus does not require handling of blood samples (p. 8, “Discussion and Conclusion”). Therefore, modified Shin fails teach 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, Anderson teaches PCR analysis of blood samples (para. 0081). Anderson further teaches for sample collection, stabilization reagents such as heparin can prevent clotting of blood samples. Anderson further teaches such reagents may generally be stored within the sample collection chamber of the device, wherein the reagents may be added to or mixed with the sample upon introduction of the sample into the device, and the reagents may be incorporated within the device in lyophilized form (0082).
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 inlet well taught by Shin with lyophilized heparin disposed in the sample inlet well as taught by Anderson (para. 0082) in order to prevent clotting of blood samples for the development of the cartridge toward POC applications that involves blood samples with a reasonable expectation of success (Anderson, para. 0146) (MPEP 2143)(I)(G).
The teachings of modified Shin as modified by Anderson would yield the magnetofluidic cartridge further comprising at least one control reagent (Anderson, para. 0082, lyophilized heparin) disposed in at least the sample inlet well and/or in at least the other chamber (Shin, sample inlet well), which control reagent is in a dried state (Anderson, para. 0082, lyophilized).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (“Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation” Sci Rep 8, 9793; 2018) in view of Song et al. (“A Multifunctional Reactor with Dry-Stored Reagents for Enzymatic Amplification of Nucleic Acids“ Anal. Chem. (2018) 90 (2): 1209–1216) as evidenced by Schaller et al. (US 20120003523) and Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024), and Mason et al. (US 20090208548 A1) as applied to claim 7, and further in view of Naegele et al. (US 6428962 B1) as applied to claim 20, and further in view of Kim (US 5629154 A).
Regarding claim 21, modified Shin teaches all of the elements of the current invention as stated above with respect to claim 20.
Modified Shin further teaches the encapsulated reagent requires heating and rehydration to be accessible for reaction (Song, Fig. 1 caption). Song further teaches the buffer is added the well with encapsulated reagents (supporting information, Fig. S3), and thus fails to the magnetofluidic cartridge further comprising at least one reconstitution buffer disposed in the sample analysis well, wherein the second temperature sensitive material (a second wax/paraffin barrier) separates the reconstitution buffer from the processing reagent.
However, Kim teaches a PCR assay device using wax barriers to segregate reagents to provide a convenient format for packaging reaction components (col. 4, lns. 11-16). Kim further teaches a primer is sealed/encapsulated beneath a wax barrier over which a buffer sits (col. 4, lns. 29-33).
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 filled with multiple layers of paraffin encapsulated reagent taught by modified Shin to include at least one buffer above the second wax/paraffin barrier/layer to rehydrate the encapsulated reagent as taught by Kim (col. 4, lns. 29-33) because such modification allows for convenient storage of buffer for rehydration of encapsulated reagent (Kim, col. 4, lns. 11-16) with a reasonable expectation of success (MPEP 2143)(I)(G). Furthermore, the claimed limitation are obvious because all the claimed elements were known in the prior art and a POSITA could have combined the elements as claimed by known method no change in their respective functions and the combination yielded nothing more than predicable results (rehydration of encapsulated reagent). See MPEP 2143(I)(A).
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (“Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation” Sci Rep 8, 9793; 2018) in view of Song et al. (“A Multifunctional Reactor with Dry-Stored Reagents for Enzymatic Amplification of Nucleic Acids“ Anal. Chem. (2018) 90 (2): 1209–1216) as evidenced by Schaller et al. (US 20120003523), Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024), and Mason et al. (US 20090208548 A1) as applied to claim 1, and further in view of Kelso et al. (US 20110269190 A1)(provided in Applicant’s IDS of 08/22/2024) as applied to claim 4, and further 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.
Modified Shin teaches cartridge comprises a plurality ports/openings/holes in the top surface of the body structure for introduction of fluids into the cartridge (Kelso, paras. 0150 and0162).
Modified Shin 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 additional 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 ports/openings/holes taught by modified Shin 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 Shin 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 additional 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 Shin teaches all of the elements of the current invention as stated above with respect to claim 37. Modified Shin further teaches, wherein the vent orifice (the top opening of one of the additional holes) and the channel fluidly communicate with one another via at least one vent channel (the channel between the two openings of the hole. The hole has a thickness, and the thickness is the length of the channel)(the holes are in fluidic communication with the channel).
Response to Arguments
Applicant’s arguments, see p. 10, filed 08/05/2026, with respect to the provisional non-statutory double patenting rejection over claim 13 of copending Application No. 18/263,010 s have been fully considered and are persuasive. In addition, the status of the application has been changed to granted and claim 13 has been canceled. Therefore, the provisional rejection of 3/2/2026 has been withdrawn.
Applicant’s arguments, see pp. 11-13, filed 08/05/2025, with respect to the rejection under 35 U.S.C. 103 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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