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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/11/2025 has been entered.
Response to Amendment
The Amendment filed 11/11/2025 has been entered. Claims 13-16, 18-19, and 26-30 remain pending in the application. Claims 26-30 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claim 13 is objected to because of the following informalities: In line 6, it is suggested to recite “the optical sample well” as “the optical sample wells”. 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 13-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wainwright et al. (US 20040241788 A1; cited in the IDS filed 11/07/2023) in view of Spero et al. (US 20200254454 A1; effectively filed 06/20/2017), Gavin et al. (US 5731212 A), and Larsen (US 20060013725 A1).
Regarding claim 13, Wainwright teaches a cartridge (Figs. 5A-5D; abstract) for determining the presence and/or amount of a microbial contaminant in a sample (interpreted as an intended use of the cartridge, see MPEP 2114; abstract), the cartridge comprising:
a. a housing (Figs. 5A-5D, top half 3 and bottom half 2) including a cover section (top half 3), a base section (bottom half 2) mechanically connected to the cover section (Figs. 5C-5D);
i. the base section (Fig. 5A, bottom half 2) including two optical sample wells (two optical cells 6’), a fluid inlet port (inlet ports 4’) and a conduit fluidly connecting the fluid inlet port and the optical sample well (conduits 8’);
ii. the conduit (Fig. 5A, conduits 8’) including an aspiration zone (Fig. 5A, region between 4’ and 14’) and a mixing zone (Fig. 5A, zone of regions 14’ and/or 16’); and
b. a pump mechanism (paragraph [0016], “pump”) fluidly connected to the fluid inlet port, the conduit and the two optical sample wells (Figs. 5A-5B teaches pump ports 12’, 12”; paragraph [0016] teaches a pump is connected to a pump port, therefore the pump is fluidly connected to the fluid inlet ports 4’, the conduits 8’, and optical cells 6’).
Wainwright fails to teach: the housing including a manifold section mechanically connected to the base section; the conduit including a fluid restrictor comprising a structure or a narrowing of the conduit configured to reduce flow between the aspiration zone and the mixing zone so as to allow proper filling of the aspiration zone; iii. the manifold section including a mixing portion configured to include a dried composition comprising a hemocyte lysate, the mixing portion corresponding to the mixing zone of the conduit, and a sample well portion corresponding to the optical sample wells of the base section, wherein when the manifold section is connected together with the cover section and the base section, the sample well portion forms the bottom of the optical sample wells of the base section; and the pump mechanism is integrated into the base section; the pump mechanism is a three-position syringe, wherein a first position creates a vacuum to introduce the sample into the aspiration zone, a second position provides transport from the aspiration zone, through the fluid restrictor, to the mixing zone, and a third position provides transport from the mixing zone to the sample wells.
Wainwright teaches a mixing portion (Figs. 5A-5D, region 14’, 14”) comprises an immobilized hemocyte lysate (paragraph [0086]), wherein the hemocyte lysate may be dried on the mixing portion (paragraphs [0085],[0088]). Wainwright teaches a sample is drawn into a region to mix with hemolysate (paragraph [0114]). Wainwright teaches use of optical cartridges for optical detection of samples (paragraph [0007]), wherein the cartridge includes transparent materials to allow a sample to be tested (paragraph [0055]).
Spero teaches modular active surfaces devices for microfluidic systems (abstract; Fig. 1) for processing of biological materials (paragraph [0002]). Spero teaches a housing (Figs. 1A-1B) including a manifold section (modular active surface device 100) mechanically connected to the base section (fluidics cartridge 200). Spero teaches the manifold section (Figs. 1A-1B, 22A-22B, modular active surface devices 100) including a mixing portion (Figs. 22A-22B, antechamber 114 and fluid path 116) configured to include a dried composition (paragraphs [0117]-[0118] and Figs. 22A-22B teaches dried reagent 170 and 175 provided in at least the antechamber 114), and a sample well portion (Figs. 1A-1B, reaction chamber 105). Spero teaches the manifold section (Figs. 2A-2B) comprises the sample well portion (elements 140, 110), wherein at least substrate 130 forms the bottom of the reaction chamber (Fig. 2B). Spero teaches wherein when the manifold section (Figs. 1A-1B; modular active surface device 100) is connected together with the base section (fluidics cartridge 200), the sample well portion forms (Figs. 1A-1B, reaction chamber 105) the bottom of an optical sample well of the base section (Figs. 1B and 2B shows reaction chamber 105 with a bottom 130 as a bottom of an optical sample well of the base section; paragraph [0081] teaches element 130 can include optical transparency for optical sensor and illumination applications). Spero teaches the substrate of the manifold section can include optical transparency for optical sensor and illumination applications (paragraph [0081]). Spero teaches as the sample fluid flows along fluid path toward reaction chamber, the dried reagent dissolves (i.e., rehydrates or reconstitutes) and the mixture of sample fluid and reagent flows into reaction chamber (paragraph [0117]). Spero teaches the purpose of the extended length of the serpentine fluid path is to ensure that there is adequate time for dried reagent pellet to dissolve completely before reaching reaction chamber (paragraph [0118]). Spero teaches modular active surface devices provide drop-in modules for easily integrating into any fluidics cartridges or systems; and because the presently disclosed modular active surface devices are provided separately from the end users' fluidics cartridges, the cost and complexity of providing the active surface can be separated from that of, for example, low cost plastic fluidics cartridges (paragraph [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing of Wainwright to incorporate Spero’s teachings of a drop-in module that includes a mixing portion, sample well portion and dried reagents for a fluidic cartridge and a substrate including optical transparency for optical sensor and illumination applications (Figs. 1-2, 22; paragraphs [0081],[0117]-[0118]) and Wainwright’s teachings of hemocyte lysate dried on the mixing portion (paragraphs [0085],[0088]), the cartridge including transparency for optical testing (paragraphs [0007],[0005]), and a sample is drawn into a region to mix with hemolysate (paragraph [0114]) to provide: the housing including a manifold section mechanically connected to the base section; iii. the manifold section including a mixing portion configured to include a dried composition comprising a hemocyte lysate, the mixing portion corresponding to the mixing zone of the conduit, and a sample well portion corresponding to the optical sample wells of the base section, wherein when the manifold section is connected together with the cover section and the base section, the sample well portion forms the bottom of the optical sample wells of the base section. Doing so would have a reasonable expectation of successfully allowing for complete mixing and dissolving of a sample with the hemocyte lysate (Spero, paragraph [0118]), optical analysis of the sample well portion, and improving modularity of the overall housing, allowing for easy integration into the overall cartridge while allowing for the cost and complexity of the manifold to be separate from that of the overall cartridge as taught by Spero (paragraph [0064]).
Modified Wainwright fails to teach: the conduit including a fluid restrictor comprising a structure or a narrowing of the conduit configured to reduce flow between the aspiration zone and the mixing zone so as to allow proper filling of the aspiration zone; and the pump mechanism is integrated into the base section; the pump mechanism is a three-position syringe, wherein a first position creates a vacuum to introduce the sample into the aspiration zone, a second position provides transport from the aspiration zone, through the fluid restrictor, to the mixing zone, and a third position provides transport from the mixing zone to the sample wells.
Gavin teaches a cuvette based testing device for analyzing a fluid sample (abstract; Fig. 1) comprising conduits (12a-12e) including dried reagent compounds (32) and fluid restrictors (28). Gavin teaches a restricted region 28a creates turbulence in the flow of the test sample 60 that mixes the test sample with the reagent compound within the confines of the conduit 12 (column 7, lines 33-35). Gavin teaches the fluid restrictor (Fig. 1, element 28) comprising a structure or a narrowing of the conduit (Fig. 1 shows restricted region 28 being a structure or a narrowing of the conduit) structurally capable of reducing flow between different zones (Fig. 1 shows restricted region 28 being a narrowing of the conduit between two zones of the conduit, therefore, the narrowing structure is structurally capable of reducing flow due to its shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit of modified Wainwright to incorporate the teachings of a conduit including a fluid restrictor between zones of Gavin (Fig. 1; column 7, lines 33-35) to provide: the conduit including a fluid restrictor comprising a structure or a narrowing of the conduit configured to reduce flow between the aspiration zone and the mixing zone so as to allow proper filling of the aspiration zone. Doing so would have a reasonable expectation of successfully improving mixing of a sample as discussed by Gavin (column 7, lines 33-35).
Modified Wainwright fails to teach: the pump mechanism is integrated into the base section; the pump mechanism is a three-position syringe, wherein a first position creates a vacuum to introduce the sample into the aspiration zone, a second position provides transport from the aspiration zone, through the fluid restrictor, to the mixing zone, and a third position provides transport from the mixing zone to the sample wells.
Larsen teaches a disposable cartridge for characterizing particles, such as for single-use analysis (abstract). Larsen teaches the cartridge (Fig. 4) comprising a mixing chamber (3), fluid restrictors (Fig. 4, narrowed passageways between elements 3 and 5, and between elements 5 and 6), a collection chamber (5) and volume metering chamber (6). Larsen teaches the cartridge (Fig. 4) comprising a syringe (Fig. 4, piston 9 and surrounding area, which is interpreted as a syringe) integrated into a base section (Fig. 4), where the syringe is built into the cartridge for directly appliance of a negative or positive pressure to move liquid (paragraphs [0094],[0129]) and replaces an external source of pressure (paragraph [0069]). Larsen teaches the syringe is structurally capable of functioning as a three-position syringe (Fig. 4 shows the piston 4 is capable of moving to different positions along the barrel structure to provide negative or positive pressure to move liquid), wherein a first position creates a vacuum to introduce the sample into the aspiration zone (paragraphs [0094],[0129] teach the piston of the syringe capable of applying a negative or positive pressure to move liquid; Fig. 4 shows a cavity 10 for receiving blood sample, i.e. aspiration zone; therefore, the piston 9 is capable of creating a vacuum to introduce a sample into the cavity 10), a second position provides transport from the aspiration zone, through the fluid restrictor, to the mixing zone (paragraphs [0094],[0129] teach the piston of the syringe capable of applying a negative or positive pressure to move liquid; Fig. 4 and paragraph [0122] teaches a sample is moved from the cavity 10, i.e. aspiration zone, into mixing chamber 3, i.e. mixing zone, via a narrowed passage between elements 10 and 3, i.e. fluid restrictor; therefore, the piston 9 is capable of creating a vacuum to transport a sample from an aspiration zone to a mixing zone through a fluid restrictor), and a third position provides transport from the mixing zone to the sample wells (paragraphs [0094],[0129] teach the piston of the syringe capable of applying a negative or positive pressure to move liquid; Fig. 4 and paragraphs [0122]-[0123] teaches a sample is moved to chambers 5 and 6, i.e. sample wells; therefore, the piston 9 is capable of creating a vacuum to transport a sample from the mixing zone to the sample wells).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge and pump mechanism of modified Wainwright to incorporate the teachings of the syringe is built into the cartridge for directly appliance of a negative or positive pressure to move liquid which replaces an external source of pressure of Larsen (Fig. 4; paragraphs [0069],[0094], [0129]) to provide: the pump mechanism is integrated into the base section; the pump mechanism is a three-position syringe, wherein a first position creates a vacuum to introduce the sample into the aspiration zone, a second position provides transport from the aspiration zone, through the fluid restrictor, to the mixing zone, and a third position provides transport from the mixing zone to the sample wells. Doing so would have a reasonable expectation of successfully improving integration of components of the cartridge as taught by Larsen (Fig. 4; paragraphs [0069],[0094], [0129]) and thus allowing for proper fluid transport between areas of the cartridge.
Note that the limitations of the fluid restrictor and pump mechanism are interpreted as functional limitations of the claimed cartridge. A recitation of a functional limitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. See MPEP 2114. The apparatus of modified Wainwright is identical to the presently claimed structure. Since modified Wainwright discloses the “fluid restrictor comprising a structure or a narrowing of the conduit” and the “pump mechanism” as claimed and therefore, would have the ability to perform the functions recited in the claim. See MPEP 2112.01 (I).
Regarding claim 14, modified Wainwright fails to explicitly teach wherein the base section (Wainwright, Fig. 5A, bottom half 2) includes four optical sample wells, wherein two of the four optical sample wells are configured to include an agent representative of the microbial contaminant dried in the optical sample wells.
Wainwright teaches embodiments of the housing comprising four optical sample wells (Figs. 2, 4, 6, optical cells 6), wherein two of the four optical sample wells are configured to include an agent representative of the microbial contaminant dried in the optical sample wells (note that “agent” is not positively recited structurally and is interpreted as a functional limitation due to the phrase “configured to” of claim 14, see MPEP 2114; paragraph [0130] teaches samples mixed with LAL is drawn to the optical cell for measurement, therefore, the optical cells are structurally capable of including an agent representative of the microbial contaminant dried in the optical sample wells at a later time). Wainwright teaches a bacterial endotoxin is disposed in at least one conduit of the cartridge (paragraphs [0018],[0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base section of modified Wainwright to incorporate the teachings of embodiments of four optical sample wells of Wainwright (Figs. 2, 4, 6) to provide: wherein the base section includes four optical sample wells, wherein two of the four optical sample wells are configured to include an agent representative of the microbial contaminant dried in the optical sample wells. Doing so would have a reasonable expectation of successfully improving throughput of sample analysis by providing additional optical sample wells.
Regarding claim 15, modified Wainwright fails to teach wherein the manifold section further includes the agent representative of the microbial contaminant dried on the sample well portion of the manifold section.
Wainwright teaches a bacterial endotoxin, i.e. agent representative of the microbial contaminant, is dried and disposed in at least one conduit of the cartridge (paragraphs [0018],[0057]). Wainwright teaches a region containing immobilized endotoxin (Fig. 5C, element 22). Wainwright teaches an embodiment where endotoxin was added to sample wells (paragraph [0141]).
Spero teaches modular active surfaces devices for microfluidic systems (abstract; Fig. 1) for processing of biological materials (paragraph [0002]). Spero teaches a housing (Figs. 1A-1B) including a manifold section (modular active surface device 100), the manifold section (Figs. 1A-1B, 22A-22B, modular active surface devices 100) including a mixing portion (Figs. 22A-22B, antechamber 114 and fluid path 116) configured to include a dried composition (paragraphs [0117]-[0118] and Figs. 22A-22B teaches dried reagent 170 and 175 provided in at least the antechamber 114). Spero teaches the dried reagent can be provided within an antechamber, along a fluid path, or both (paragraphs [0117]-[0118]). Spero teaches as the sample fluid flows along fluid path toward reaction chamber, the dried reagent dissolves (i.e., rehydrates or reconstitutes) and the mixture of sample fluid and reagent flows into reaction chamber (paragraph [0117]). Spero teaches modular active surface devices provide drop-in modules for easily integrating into any fluidics cartridges or systems, and because the presently disclosed modular active surface devices are provided separately from the end users' fluidics cartridges, the cost and complexity of providing the active surface can be separated from that of, for example, low cost plastic fluidics cartridges (paragraph [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manifold section of modified Wainwright to incorporate the teachings of a drop-in module that includes dried compositions in a chamber and/or fluid path of Spero (paragraphs [0117]-[0118]) and the teachings of a bacterial endotoxin, i.e. agent representative of the microbial contaminant, is dried and disposed in at least one conduit of the cartridge of Wainwright (paragraphs [0018],[0057]; Fig. 5C, element 22) to provide: wherein the manifold section further includes the agent representative of the microbial contaminant dried on the sample well portion of the manifold section. Doing so would have a reasonable expectation of successfully improving modularity of the overall housing, allowing for easy integration into the overall cartridge while allowing for the cost and complexity of the manifold to be separate from that of the overall cartridge as taught by Spero (paragraph [0064]).
Regarding claim 16, Wainwright further teaches cartridge of claim 13, further comprising a chromogenic substrate dried on the housing (Fig. 5D and paragraph [0086] teaches immobilized chromogenic substrate 24; paragraphs [0081],[0088] teaches the chromogenic substrate is in dried form). Modified Wainwright fails to teach the chromogenic substrate dried on the mixing portion of the manifold section.
Spero teaches a housing (Figs. 1A-1B) including a manifold section (modular active surface device 100), the manifold section (Figs. 1A-1B, 22A-22B, modular active surface devices 100) including a mixing portion (Figs. 22A-22B, antechamber 114 and fluid path 116) configured to include a dried composition (paragraphs [0117]-[0118] and Figs. 22A-22B teaches dried reagent 170 and 175 provided in at least the antechamber 114). Spero teaches the dried reagent can be provided within an antechamber, along a fluid path, or both (paragraphs [0117]-[0118]). Spero teaches as the sample fluid flows along fluid path toward reaction chamber, the dried reagent dissolves (i.e., rehydrates or reconstitutes) and the mixture of sample fluid and reagent flows into reaction chamber (paragraph [0117]). Spero teaches modular active surface devices provide drop-in modules for easily integrating into any fluidics cartridges or systems, and because the presently disclosed modular active surface devices are provided separately from the end users' fluidics cartridges, the cost and complexity of providing the active surface can be separated from that of, for example, low cost plastic fluidics cartridges (paragraph [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manifold section of modified Wainwright to incorporate the teachings of a drop-in module that includes dried compositions in a chamber and/or fluid path of Spero (paragraphs [0117]-[0118]) and the teachings of a chromogenic substrate dried in the cartridge of Wainwright (Fig. 5D, paragraph, [0081],[0086], [0088]) to provide: the chromogenic substrate dried on the mixing portion of the manifold section. Doing so would have a reasonable expectation of successfully improving modularity of the overall housing, allowing for easy integration into the overall cartridge while allowing for the cost and complexity of the manifold to be separate from that of the overall cartridge as taught by Spero (paragraph [0064]).
Regarding claim 18, Wainwright further teaches wherein the hemocyte lysate is limulus amoebocyte lysate (paragraphs [0066],[0122], “LAL”).
Regarding claim 19, Wainwright further teaches wherein the agent is a bacterial endotoxin (note that “agent” is not positively recited structurally and is interpreted as a functional limitation due to the phrase “configured to” of claim 14, see MPEP 2114; paragraph [0130] teaches samples mixed with LAL is drawn to the optical cell for measurement, therefore, the optical cells are structurally capable of including a bacterial endotoxin dried in the optical sample wells at a later time).
Response to Arguments
Applicant's arguments, see pages 5-8, filed 11/11/2025, with respect to the rejections of claims 13-16 and 18-19 under 35 U.S.C. 103 over Wainwright, Spero, Gavin and Larsen, specifically regarding claim 13, have been fully considered but they are not persuasive.
In response to applicant’s argument that the combination of the prior art fails to teach or suggest all of the limitations of claim 13, specifically, Spero fails to teach “a manifold section including a sample well portion corresponding to the optical sample wells of the base section, wherein when the manifold section is connected together with the cover section and the base section, the sample well portion forms the bottom of the optical sample wells of the base section” (Remarks, page 7), the examiner disagrees.
First, it is noted that the features upon which applicant relies (i.e., “the optical well of the presently claimed invention is used to measure an optical property of the mixed sample, wherein a change in the optical property is indicative of the presence of the microbial contaminant in the sample”, Remarks, page 7; “optical property measurements are conducted within the reaction chamber”, Remarks, page 7) are not recited in the rejected claim(s). 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).
Second, in response to applicant's arguments against the references individually (i.e. Spero), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, and as discussed in the rejection of claim 13 under 35 U.S.C. 103 above:
Wainwright provides teachings of: a mixing portion (Figs. 5A-5D, region 14’, 14”) comprises an immobilized hemocyte lysate (paragraph [0086]), wherein the hemocyte lysate may be dried on the mixing portion (paragraphs [0085],[0088]); a sample is drawn into a region to mix with hemolysate (paragraph [0114]); and use of optical cartridges for optical detection of samples (paragraph [0007]), wherein the cartridge includes transparent materials to allow a sample to be tested (paragraph [0055]).
Spero provides teachings of a drop-in module that includes a mixing portion, sample well portion and dried reagents for a fluidic cartridge (Figs. 1-2, 22; paragraphs [0117]-[0118]). Spero teaches the manifold section (Figs. 1A-1B, 22A-22B, modular active surface devices 100) including a mixing portion (Figs. 22A-22B, antechamber 114 and fluid path 116) configured to include a dried composition (paragraphs [0117]-[0118] and Figs. 22A-22B teaches dried reagent 170 and 175 provided in at least the antechamber 114), and a sample well portion (Figs. 1A-1B, reaction chamber 105). Spero teaches the manifold section (Figs. 2A-2B) comprises the sample well portion (elements 140, 110), wherein at least substrate 130 forms the bottom of the reaction chamber (Fig. 2B). Spero teaches wherein when the manifold section (Figs. 1A-1B; modular active surface device 100) is connected together with the base section (fluidics cartridge 200), the sample well portion forms (Figs. 1A-1B, reaction chamber 105) the bottom of an optical sample well of the base section (Figs. 1B and 2B shows reaction chamber 105 with a bottom 130 as a bottom of an optical sample well of the base section; paragraph [0081] teaches element 130 can include optical transparency for optical sensor and illumination applications). Spero teaches the substrate of the manifold section can include optical transparency for optical sensor and illumination applications (paragraph [0081]). Spero teaches as the sample fluid flows along fluid path toward reaction chamber, the dried reagent dissolves (i.e., rehydrates or reconstitutes) and the mixture of sample fluid and reagent flows into reaction chamber (paragraph [0117]).
It would have been obvious to one of ordinary skill in the art to have modified the housing of Wainwright to incorporate Spero’s teachings of a drop-in module that includes a mixing portion, sample well portion and dried reagents for a fluidic cartridge and a substrate including optical transparency for optical sensor and illumination applications (Figs. 1-2, 22; paragraphs [0081],[0117]-[0118]) and Wainwright’s teachings of hemocyte lysate dried on the mixing portion (paragraphs [0085],[0088]), the cartridge including transparency for optical testing (paragraphs [0007],[0005]), and a sample is drawn into a region to mix with hemolysate (paragraph [0114]) to provide: the housing including a manifold section mechanically connected to the base section; iii. the manifold section including a mixing portion configured to include a dried composition comprising a hemocyte lysate, the mixing portion corresponding to the mixing zone of the conduit, and a sample well portion corresponding to the optical sample wells of the base section, wherein when the manifold section is connected together with the cover section and the base section, the sample well portion forms the bottom of the optical sample wells of the base section. Doing so would have a reasonable expectation of successfully allowing for complete mixing and dissolving of a sample with the hemocyte lysate (Spero, paragraph [0118]), optical analysis of the sample well portion, and improving modularity of the overall housing, allowing for easy integration into the overall cartridge while allowing for the cost and complexity of the manifold to be separate from that of the overall cartridge as taught by Spero (paragraph [0064]).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have combined the references to arrive at the claimed manifold section for improving mixing and dissolving of a sample with the hemocyte lysate (Spero, paragraph [0118]), allowing for optical analysis of the sample well portion, improving modularity of the overall housing therefore allowing for easy integration into the overall cartridge while allowing for the cost and complexity of the manifold to be separate from that of the overall cartridge as taught by Spero (paragraph [0064]).
Applicant's arguments, see page 8, filed 11/11/2025, regarding Gavin, have been fully considered but they are not persuasive.
In response to applicant’s argument that a person of ordinary skill in the art would be aware that if there is a need for an increase in sample mixing, it could be accomplished in a multi-well plate configuration and therefore one would not be motivated to modify Wainwright to include a fluid restrictor as claimed (Remarks, page 8), the examiner disagrees. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Wainwright teaches and suggests motivation for mixing: “time intervals required for mixing and incubating steps are preprogrammed for optimal sensitivity and microbial contaminant concentration range” (paragraph [0112]). Gavin provides teachings of a conduit including a fluid restrictor between zones (Fig. 1; column 7, lines 33-35), which creates turbulence in the flow of the test sample that mixes the test sample with the reagent compound within the confines of the conduit (column 7, lines 33-35).
It would have been obvious to one of ordinary skill in the art to have modified the conduit of modified Wainwright to incorporate the teachings of a conduit including a fluid restrictor between zones of Gavin (Fig. 1; column 7, lines 33-35) to provide: the conduit including a fluid restrictor comprising a structure or a narrowing of the conduit configured to reduce flow between the aspiration zone and the mixing zone so as to allow proper filling of the aspiration zone. Doing so would have a reasonable expectation of successfully improving mixing of a sample as discussed by Gavin (column 7, lines 33-35) and as desired by Wainwright.
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have combined the references to arrive at the claimed conduit including the fluid restrictor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758