Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 5, 7-8, 12, 19-23, 59, and 63-65 in the reply filed on 05/20/2026 is acknowledged.
Claims 35-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/20/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the controller comprises a linear sliding controller comprising a puncture ramp surface adapted to press the puncture piston through the fluid channel seal to couple the distal end of the first microfluidic channel and the proximal end of the second microfluidic channel” (claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Note that the figures (e.g. Fig. 1) and the specification ([0050]) appears to show a knob controller and not a linear sliding controller.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In the specification, paragraph [0036], “florescence” should read “fluorescence”.
Appropriate correction is required.
Claim Objections
Claims 21-22 and 63 are objected to because of the following informalities: It is suggested to recite the acronyms (i.e. DNA, LAMP, RNA, LED) in an unabbreviated form to establish the acronyms. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 63 and 65 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 63, claim 63 recites the limitation " the detector or photodiode" and “the LED” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 63, the term “approximately” in line 2 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 65, claim 65 recites “The microfluidic device wherein the…” in line 1. It is unclear which claim 65 is dependent upon. For examination purposes, claim 65 is interpreted as dependent on claim 64. It is suggested to recite “The microfluidic device wherein…” as “The microfluidic device of claim 64, wherein…”
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, 5, 7, 12, 19-20, 23, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Shastry et al. (US 20190021704 A1) in view of Rothacher et al. (US 20140045275 A1).
Regarding claim 1, Shastry teaches a microfluidic device (abstract; paragraph [0009]; Figs. 1-4, 7, 19, 20A-20N) comprising:
a housing (Fig. 19A, housing of the reader);
a substrate (Figs. 1-4 and 19 teaches a disposable device or cartridge 1000, i.e. substrate) adapted to be disposed within the housing (Fig. 19 shows the cartridge is adapted to be inserted into the reader), the substrate comprising:
a sample port (Figs. 5D,7 and [0104], interpreted as diluted sample cavity 201 that includes a sample inlet) adapted to receive a sample (Figs. 5D,7 and [0104],[0127]-[0128],[0132] teaches the sample cavity 201 collects a sample from a swab) and extract at least one analyte from the sample into a liquid assay sample ([0127]-[0128] teaches a dilution buffer is forced through a porous saliva collection swab and into the diluted sample cavity 201, therefore, the sample reservoir is capable of extracting the analyte from the saliva collection swab, i.e. sample, into a liquid assay sample, i.e. the diluted sample),
a sample well (Fig. 7, sample well 102) coupled to the sample port (Fig. 7 teaches sample well 102 coupled to sample cavity 201),
a reaction well (Fig. 7, interpreted as chip channel 109), a first microfluidic channel (Figs. 4A-4C and 7, interpreted as the microfluidic channel, i.e. mixing chamber 103, from element 102 to element 104) coupled at a proximal end to the sample well (Figs. 4A-4C and 7 teaches the mixing chamber 103 is coupled at a proximal end to sample well 102), and a second microfluidic channel (Figs. 4A-4C and 7, interpreted as the microfluidic channel from element 104 to chip channel 109) coupled at a distal end to the reaction well (Figs. 4A-4C teaches the microfluidic channel from element 104 to chip channel 109 is coupled at a distal end to chip channel 109), wherein a distal end of the first microfluidic channel (Figs. 4A-4C, the end of the mixing chamber 103 adjacent to element 104) and a proximal end of the second microfluidic channel (Figs. 4A-4C, the end of the microfluidic channel between element 104 and chip channel 109 that is adjacent to element 104) are isolated from each other via a fluid channel stop (Fig. 4A and [0147],[0167] teaches capillary stop 104 isolates mixing chamber 103 from the microfluidic channel between element 104 and chip channel 109),
a controller ([0046] teaches controllers for controlling the pumps and valves) adapted to meter the liquid assay sample from the sample well into the reaction well for an assay (Fig. 7 and [0147] teaches a pump to transport fluid through the fluid channels; [0161] teaches pump actuation pulls the metered sample from sample well 102 into mixing chamber 103 and [0176]-[0180] teaches sample is moved out of chamber 103 and into chip channel 109 for assay; therefore, the controller is adapted to meter the liquid assay sample from sample well 102 into chip channel 109 for assay).
While Shastry teaches capillary stops to prevent fluid from passing through the stop and requires pushing/pulling of a pump ([0051],[0147]), Shastry fails to teach: the distal end of the first microfluidic channel (Figs. 4A-4C, the end of the mixing chamber 103 adjacent to element 104) and the proximal end of the second microfluidic channel (Figs. 4A-4C, the end of the microfluidic channel between element 104 and chip channel 109 that is adjacent to element 104) are isolated from each other via a fluid channel seal; and the controller adapted to break the fluid channel seal.
Rothacher teaches an apparatus for sealed storage of liquids for a microfluidic system including a cavity and sealing cone, i.e. fluid channel seal, through which a connection to the microfluidic system is configured to be established (abstract). Rothacher teaches an embodiment (Figs. 3A-3B) comprising a first microfluidic channel (302) isolated from a second microfluidic channel (305) via a fluid channel seal (sealing cone 301). Rothacher teaches applying a force to break the fluid channel seal, thus opening the seal and establishing a connection between the channels (Fig. 3B; [0053]-[0054]). Rothacher teaches by using the fluid channel seal, i.e. sealing cone, it has surprisingly been found that the device according to the invention ensures safer storage of the fluids and simpler handling ([0035]); and liquid in the device is always separated from the microfluidic system by the fluid channel seal, which is opened only during operation ( [0036]). Rothacher teaches opening can be performed automatically ([0043]). Rothacher teaches the device allows for controlled addition of liquid to a microfluidic system and precise control of volumes of liquid delivered to the system ([0046]).
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 fluid channel stop and controller of Shastry to incorporate Rothacher’s teachings of a seal between two microfluidic channels and automated breaking or opening of the seal in order to establish a connection between the channels (Figs. 3A-3B; [0035]-[0036], [0043], [0046], [0053]-[0054]) to provide: the distal end of the first microfluidic channel and the proximal end of the second microfluidic channel are isolated from each other via a fluid channel seal; and the controller adapted to break the fluid channel seal. Doing so would have a reasonable expectation of successfully improving automated fluid handling of the liquid assay sample, improving separation of fluidic channels during operation, and improving precise control of fluid delivery to the second microfluidic channel as taught by Rothacher.
Additionally, since Rothacher teaches a seal between two microfluidic channels and automated breaking or opening of the seal in order to establish a connection between the channels (Figs. 3A-3B; [0035]-[0036], [0043], [0046], [0053]-[0054]), which has the same functional capability of preventing fluid from moving from the first to the second microfluidic channel during until desired, it would have been obvious to have substituted one known element (Shastry’s fluid channel stop) for another (Rothacher’s fluid channel seal), and the results of the substitution would have been predictable (improving automated fluid handling of the liquid assay sample, improving separation of fluidic channels during operation, and improving precise control of fluid delivery to the second microfluidic channel). See MPEP 2144.05 (II) (In re Williams, 36 F.2d 436, 438 (CCPA 1929), “…the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent”).
Regarding claim 5, Shastry further teaches wherein the substrate comprises a cartridge adapted to be removed from the housing (Fig. 19 and [0186] teaches the disable device or cartridge can be removed from the reader module).
Regarding claim 7, modified Shastry fails to teach: wherein the controller is adapted to puncture the fluid channel seal via a puncture piston.
Rothacher teaches an apparatus for sealed storage of liquids for a microfluidic system including a cavity and sealing cone through which a connection to the microfluidic system is configured to be established (abstract). Rothacher teaches an embodiment (Figs. 3A-3B) comprising a first microfluidic channel (302) isolated from a second microfluidic channel (305) via a fluid channel seal (sealing cone 301). Rothacher teaches applying a force to break the fluid channel seal, thus opening the seal and establishing a connection between the channels (Fig. 3B; [0053]-[0054]). Rothacher teaches by using the fluid channel seal, i.e. sealing cone, it has surprisingly been found that the device according to the invention ensures safer storage of the fluids and simpler handling ([0035]); and liquid in the device is always separated from the microfluidic system by the fluid channel seal, which is opened only during operation ( [0036]). Rothacher teaches opening can be performed automatically ([0043]). Rothacher teaches the device allows for controlled addition of liquid to a microfluidic system and precise control of volumes of liquid delivered to the system ([0046]). Rothacher teaches the force to pierce the fluid channel seal can be via a puncture piston, i.e. pin 203 ([0029], [0052]).
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 microfluidic device and controller of modified Shastry to incorporate Rothacher’s teachings of a seal between two microfluidic channels and automated breaking or opening of the seal using a pin in order to establish a connection between the channels (Figs. 3A-3B; [0029], [0035]-[0036], [0043], [0046], [0052]-[0054]) to provide: wherein the controller is adapted to puncture the fluid channel seal via a puncture piston. Doing so would have a reasonable expectation of successfully improving automated fluid handling of the liquid assay sample, improving separation of fluidic channels during operation, and improving precise control of fluid delivery to the second microfluidic channel as taught by Rothacher.
Regarding claim 12, modified Shastry fails to teach: wherein the controller is adapted to meter the liquid sample via a syringe piston.
Shastry teaches the cartridge includes a push/pull pumping system to drive fluid in both forward and reverse directions ([0014]). Shastry teaches controlling a pump piston ([0046]).
Rothacher teaches syringe pumps are known ([0002]). Rothacher teaches a sample can be introduced by a syringe ([0025]).
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 pumping system and controller of modified Shastry to incorporate Shastry’s teachings of a pump piston and driving fluid in the cartridge ([0014],[0046]) and Rothacher’s teachings of syringe pumps and syringes ([0002],[0025]) to provide: wherein the controller is adapted to meter the liquid sample via a syringe piston. Doing so would have a reasonable expectation of successfully allowing for pumping or driving fluid in the microfluidic device using known pumps, e.g. syringe piston.
Regarding claim 19, Shastry further teaches wherein a reagent bead is disposed within the reaction well ([0142] teaches sample metering well 102 incudes lyophilized beads having antibodies conjugated with fluorophores and [0161],[0180] teach a sample is mixed with the beads in sample well 102 and incubated sample is moved from mixing chamber 103 into chip channel 109; therefore, the reagent beads are disposed within chip channel 109, i.e. reaction well).
Regarding claim 20, Shastry further teaches wherein the reagent bead comprises a lyophilized bead comprising a concentrated assay reagent disposed on the lyophilized bead ([0142] teaches lyophilized beads having antibodies, i.e. concentrated assay reagent, conjugated with fluorophores).
Regarding claim 23, Shastry further teaches wherein a type of assay is determined by one or more components disposed on the reagent bead (interpreted as an intended use of the microfluidic device, see MPEP 2114; [0058] teaches a type of analyte of interest and antibodies configured to bind to one type of the plurality of analytes; [0142] teaches lyophilized beads having antibodies; therefore, the type of assay is capable of being determined, e.g. by a user, by the antibodies disposed on the reagent bead).
Regarding claim 59, Shastry further teaches wherein the assay comprises a fluorescent assay (interpreted as an intended use of the microfluidic device, see MPEP 2114; [0084] teaches an example of an assay for detecting an analyte including detectable labels; [0142] teaches lyophilized beads having antibodies conjugated with fluorophores; therefore, the assay that uses fluorophores, is interpreted as a fluorescent assay; i.e. the microfluidic device is capable of being used for a fluorescent assay).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shastry in view of Rothacher as applied to claim 7 above, and further in view of Pais et al. (US 20200030795 A1).
Regarding claim 8, modified Shastry fail to teach: wherein the controller comprises a linear sliding controller comprising a puncture ramp surface adapted to press the puncture piston through the fluid channel seal to couple the distal end of the first microfluidic channel and the proximal end of the second microfluidic channel.
Pais teaches devices for automated processing of biological samples through multiple sample preparation steps, including a microfluidic device (abstract). Pais teaches reagent pouches and plungers that depress on the pouches to rupture the frangible sealing layer and squeeze their contents out ([0041]). Pais teaches a sharp object or protrusion, i.e. puncture piston, that is capable of rupturing the frangible seal when sufficient actuation force is applied to it ([0041]; Fig. 1, sharp object 105 that is used to rupture frangible seal layer 104). Pais teaches actuation steps can utilize linear sliding actuator elements, i.e. linear sliding controller ([0098]). Pais teaches a puncture ramp surface (Fig. 13, top outer ramp surface above rupture elements 1305) adapted to press puncture pistons (rupture balls 1305) when force is applied, therefore breaking the frangible seal to open a pathway for reagents to enter ([0106]). Pais teaches applying force to puncture ramp surfaces (Fig. 14, deformable lidding 1407 that is a ramp surface shape) to press rupture balls (1408) through a fluid channel seal (1406).
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 controller of modified Shastry to incorporate Pais’s teachings of applying force to puncture ramp surfaces to press rupture balls through a fluid channel seal and actuation force includes the use of linear actuator elements (Figs. 13-14; [0041], [0098], [0106]) to provide: wherein the controller comprises a linear sliding controller comprising a puncture ramp surface adapted to press the puncture piston through the fluid channel seal to couple the distal end of the first microfluidic channel and the proximal end of the second microfluidic channel. Doing so would have a reasonable expectation of successfully improving control and automation of applying desired force to the puncture piston to break the fluid channel seal to fluidically couple the first and second microfluidic channels.
In an alternative interpretation of claims 19-20, claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shastry in view of Rothacher as applied to claim 1 above, and further in view of Nowakowski et al. (US 20160310948 A1). In this alternative interpretation, Shastry is interpreted as failing to teach a reagent bead is disposed within the reaction well, wherein the reagent bead comprises a lyophilized bead comprising a concentrated assay reagent disposed on the lyophilized bead.
Regarding claim 19, modified Shastry fails to teach: a reagent bead is disposed within the reaction well.
Shastry teaches sample metering well incudes lyophilized beads having antibodies conjugated with fluorophores ([0142]).
Nowakowski teaches a disposable cassette for detecting nucleic acids or performing other assays (abstract). Nowakowski teaches typical microfluidic devices employ reactions, such as LAMP, to provide sufficient test specimen volumes to ensure detection of scarce assay targets in dilute specimens ([0009]). Nowakowski teaches incorporation of lyophilized reagents into the disposable platform ([0087]). Nowakowski teaches an amplification chamber comprising a lyophilized amplification reagent mix ([0089]). Nowakowski teaches lyophilized pellets can include reagents necessary for nucleic acid amplification, such as primers and enzymes ([0120]). Nowakowski teaches lyophilized reagent pellets are durable and easily placed into specific chambers, such as flow paths of a reaction chamber and amplification chamber, of the fluidic component to allow for sample reaction at the desired time to optimize performance ([0149]).
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 microfluidic device of modified Shastry to incorporate Nowakowski’s teachings of lyophilized pellets comprising necessary reagents placed into specific chambers ([0087],[0089], [0120],[0149]) to provide: a reagent bead (i.e. comprising a lyophilized bead comprising a concentrated assay reagent disposed on the lyophilized bead) is disposed within the reaction well. Doing so would have a reasonable expectation of successfully improving sample processing and reactions with necessary reagents in desired chambers of the microfluidic device to optimize the performance of the assay.
Regarding claim 20, modified Shastry further teaches wherein the reagent bead comprises a lyophilized bead comprising a concentrated assay reagent disposed on the lyophilized bead (see above claim 19).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shastry in view of Rothacher as applied to claim 19 above, and further in view of Nowakowski et al. (US 20160310948 A1).
Regarding claim 21, modified Shastry fails to teach: wherein the reagent bead comprises analyte-specific DNA primers and analyte-independent reagents including enzymes for a LAMP assay.
Nowakowski teaches a disposable cassette for detecting nucleic acids or performing other assays (abstract). Nowakowski teaches typical microfluidic devices employ reactions, such as LAMP, to provide sufficient test specimen volumes to ensure detection of scarce assay targets in dilute specimens ([0009]). Nowakowski teaches incorporation of lyophilized reagents into the disposable platform ([0087]). Nowakowski teaches an amplification chamber comprising a lyophilized amplification reagent mix ([0089]). Nowakowski teaches lyophilized pellets can include reagents necessary for nucleic acid amplification, such as primers and enzymes ([0120]). Nowakowski teaches lyophilized reagent pellets are durable and easily placed into specific chambers, such as flow paths of a reaction chamber and amplification chamber, of the fluidic component to allow for sample reaction at the desired time to optimize performance ([0149]). Nowakowski teaches an example of an influenza A and B test cassette comprising a lyophilized bead, oligonucleotide primers to influenza A and influenza B, and reverse transcription and nucleic acid amplification reagents and enzymes present as a lyophilized pellet ([0190]).
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 microfluidic device of modified Shastry to incorporate Nowakowski’s teachings of lyophilized pellets comprising necessary reagents, such as oligonucleotide primers for an analyte and enzymes for amplification ([0087],[0089], [0120],[0149], [0190]) and amplification reactions including LAMP ([0009]) to provide: wherein the reagent bead comprises analyte-specific DNA primers and analyte-independent reagents including enzymes for a LAMP assay. Doing so would have a reasonable expectation of successfully improving sample processing, e.g. amplification, with necessary reagents to provide sufficient test specimen volumes to ensure detection of scarce assay targets in dilute specimens, therefore optimizing the performance of the assay.
Regarding claim 22, modified Shastry fails to teach: wherein the reagent bead further comprises reverse transcriptase for converting viral RNA into DNA for amplification.
Nowakowski teaches a disposable cassette for detecting nucleic acids or performing other assays (abstract). Nowakowski teaches typical microfluidic devices employ reactions, such as LAMP, to provide sufficient test specimen volumes to ensure detection of scarce assay targets in dilute specimens ([0009]). Nowakowski teaches incorporation of lyophilized reagents into the disposable platform ([0087]). Nowakowski teaches an amplification chamber comprising a lyophilized amplification reagent mix ([0089]). Nowakowski teaches lyophilized pellets can include reagents necessary for nucleic acid amplification, such as primers and enzymes ([0120]). Nowakowski teaches lyophilized reagent pellets are durable and easily placed into specific chambers, such as flow paths of a reaction chamber and amplification chamber, of the fluidic component to allow for sample reaction at the desired time to optimize performance ([0149]). Nowakowski teaches an example of an influenza A and B test cassette comprising a lyophilized bead, oligonucleotide primers to influenza A and influenza B, and reverse transcription and nucleic acid amplification reagents and enzymes present as a lyophilized pellet ([0190]). Nowakowski teaches reverse transcriptase is required to accomplish the reverse transcription of RNA in the sample into cDNA; and nucleic acid amplification is performed ([0100]).
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 microfluidic device of modified Shastry to incorporate Nowakowski’s teachings of lyophilized pellets comprising necessary reagents, such as reverse transcriptase ([0087],[0089], [0100], [0120],[0149], [0190]) to provide: wherein the reagent bead further comprises reverse transcriptase for converting viral RNA into DNA for amplification. Doing so would have a reasonable expectation of successfully improving sample processing, e.g. reverse transcription and amplification, with necessary reagents to provide sufficient test specimen volumes to ensure detection of scarce assay targets in dilute specimens, therefore optimizing the performance of the assay.
Claims 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Shastry in view of Rothacher as applied to claim 1 above, and further in view of Griss et al. (US 20090311796 A1).
Regarding claim 63, Shastry further teaches a detector or photodiode ([0045], optical detector, e.g. photodiode, CCD) and LED ([0045]).
Modified Shastry fails to teach: wherein the detector or photodiode is disposed approximately 90 degrees from a path of illumination of the LED through the reaction well.
Griss teaches a microfluidic analytical device for analysis of chemical or biological samples (abstract; [0001]). Griss teaches a mixing chamber serving as a detection chamber, and optical detection of absorbance and fluorescence ([0045]). Griss teaches absorbance measurement can be in-plane detection, which is characterized by the incident light being reflected by Total Internal Reflection (TIR) integrated with the analytical device and positioned at a side of the mixing chamber so that light is passing through the mixing chamber in a direction nearly parallel to the plane of the device body ([0046]); wherein the detector can in this case be positioned either radially outwards of the device body at nearly 90 degrees from the incident light or on either side, bottom or top, of the analytical device in case, by a similar mechanism, light is reflected at the opposite side of the mixing chamber perpendicularly out of the device body ([0046]).
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 detector or photodiode and LED of modified Shastry to incorporate Griss’s teachings of 90 degree positioning of a detector relative to a light source for optical measurement of a detection chamber ([0045]-[0046]) to provide: wherein the detector or photodiode is disposed approximately 90 degrees from a path of illumination of the LED through the reaction well. Doing so would have a reasonable expectation of successfully improving positioning of the LED and detector for proper optical detection and analysis of the reaction well.
Regarding claim 64, modified Shastry fails to teach: wherein illuminating light is directed into the reaction well by at least one total internal reflectance element positioned within or adjacent to the reaction well.
Griss teaches a microfluidic analytical device for analysis of chemical or biological samples (abstract; [0001]). Griss teaches a mixing chamber serving as a detection chamber, and optical detection of absorbance and fluorescence ([0045]). Griss teaches absorbance measurement can be in-plane detection, which is characterized by the incident light being reflected by Total Internal Reflection (TIR) integrated with the analytical device and positioned at a side of the mixing chamber so that light is passing through the mixing chamber in a direction nearly parallel to the plane of the device body ([0046]); wherein the detector can in this case be positioned either radially outwards of the device body at nearly 90 degrees from the incident light or on either side, bottom or top, of the analytical device in case, by a similar mechanism, light is reflected at the opposite side of the mixing chamber perpendicularly out of the device body ([0046]). Griss teaches by a similar mechanism, light is reflected at the opposite side of the mixing chamber perpendicularly out of the device body ([0046]). Griss teaches reflection of light out of a substrate by TIR ([0068]).
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 detector or photodiode and LED of modified Shastry to incorporate Griss’s teachings of incident light being reflected by Total Internal Reflection (TIR) integrated with the analytical device ([0045]-[0046]) to provide: wherein illuminating light is directed into the reaction well by at least one total internal reflectance element positioned within or adjacent to the reaction well. Doing so would have a reasonable expectation of successfully improving positioning illuminating light for proper optical detection and analysis of the reaction well.
Regarding claim 65, modified Shastry fails to teach: wherein the at least one total internal reflectance element is adapted to direct transmitted or emitted fluorescent light to a detector.
Griss teaches a microfluidic analytical device for analysis of chemical or biological samples (abstract; [0001]). Griss teaches a mixing chamber serving as a detection chamber, and optical detection of absorbance and fluorescence ([0045]). Griss teaches absorbance measurement can be in-plane detection, which is characterized by the incident light being reflected by Total Internal Reflection (TIR) integrated with the analytical device and positioned at a side of the mixing chamber so that light is passing through the mixing chamber in a direction nearly parallel to the plane of the device body ([0046]); wherein the detector can in this case be positioned either radially outwards of the device body at nearly 90 degrees from the incident light or on either side, bottom or top, of the analytical device in case, by a similar mechanism, light is reflected at the opposite side of the mixing chamber perpendicularly out of the device body ([0046]). Griss teaches by a similar mechanism, light is reflected at the opposite side of the mixing chamber perpendicularly out of the device body ([0046]). Griss teaches reflection of light out of a substrate by TIR ([0068]).
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 detector or photodiode and LED of modified Shastry to incorporate Griss’s teachings of light from the detection chamber being reflected by Total Internal Reflection (TIR) ([0045]-[0046], [0068]) to provide: wherein the at least one total internal reflectance element is adapted to direct transmitted or emitted fluorescent light to a detector. Doing so would have a reasonable expectation of successfully improving positioning of optical elements, e.g. TIR element, for proper optical detection and analysis of the reaction well.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Khattak et al. (US 20190314810 A1; cited in the IDS filed 08/21/2024) teaches a seal piercer that includes a slide configured to move in a direction to pierce the sealing material, i.e. linear sliding controller ([0014], [0201]).
Holmes et al. (US 20180231533 A1) teaches portable medical devices for detection of analytes from a biological fluid (abstract) comprising a sample collection well SCW (Figs. 4A-4C), metering element ME (Figs. 4A-4C), metering channel MC (Figs. 4A-4C). Holmes teaches the metering element comprises a pin configured to be movable from an open position to a closed position; and in the closed position the pin can block the metering channel ([0010]).
Chemelli et al. (US 5674653 A) teaches a apparatus for light measurement wherein the chambers are sealed with burstable seals allowing fluid communication between the chambers upon the application of a predetermined pressure (abstract).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
Prosecution Insights