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 .
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 first side of the first projection extends substantially vertically adjacent to an inlet of the first chamber, and a second side of the projection extends upward toward a top of the at first chamber at an angle less than approximately 60 degrees from the first side extending substantially vertically (claim 3) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 4602, 4606, 4610, 4611, 4612, 4616, and 4618. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-7 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.
Claim 3 recites the limitation "the projection" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 8-11 and 14-21 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Nowakowski et al. (US 2016/0310948).
Regarding claim 1, Nowakowski et al. teach:
1. A fluidic test cassette comprising:
a plurality of chambers (¶ 0010+) comprising at least a first chamber (e.g., reaction chamber 4003, 5006) and a second chamber (e.g., reaction chamber 4003, 5011), wherein:
the first chamber includes a first projection extending downward into the first chamber (see annotated Fig. 38 for example); and
the second chamber includes a second projection formed proximal an outlet (see annotated Fig. 38 for example) and capable of being disposed orthogonally to a direction of fluid flow, thereby preventing fluid from flowing directly into the outlet (see Figs. 38-42 & ¶ 0014-0015);
a plurality of vent pockets (e.g., first vent pocket, second vent pocket; vent valves 5009) connected to the plurality of chamber (see Fig. 38 & ¶ 0088, 0111+ for example); and
a heat labile material for sealing at least one of the plurality of vent pockets (¶ 0088+).
Regarding claims 2, 8-11 and 14-21, Nowakowski et al. teach:
2. The fluidic test cassette of claim 1, wherein the first projection is generally triangular in shape (see annotated Fig. 38 for example).
8. The fluidic test cassette of claim 1, wherein the second projection is triangular or trapezoidal in shape (see annotated Fig. 38 & ¶ 0014+ for example).
9. The fluidic test cassette of claim 1, wherein the second projection in the second chamber forms a tapered outlet (see annotated Fig. 38 & Figs. 39-40 for example).
10. The fluidic test cassette of claim 1, wherein a channel (e.g., 4306) located downstream of the outlet comprises turns capable for increasing an effective length of the channel (see i.e., outlet channel 4306 travels through stacked serial flow control features 4303, 4302, and 4301 which provide a tortuous route for the fluid to flow, providing an increased outlet channel length in a small vertical space. ¶ 0160).
11. The fluidic test cassette of claim 1, wherein the plurality of chambers includes a detection chamber (e.g., 230) comprising a lateral flow detection pathway (see i.e., the cassette comprising a vertically oriented detection chamber, a lateral flow detection strip ¶ 0012; e.g., detection strip 235 ¶ 0125, 0136), and/or detection particles selected from the group consisting of dye polystyrene microspheres, latex, colloidal gold, colloidal cellulose, nanogold, or semiconductor nanocrystals, or combinations thereof (see ¶ 0136 for example).
12. The fluidic test cassette of claim 11, wherein the detection chamber further comprises a sample receiving chamber (e.g., capillary pool or space 93 ¶ 0136) capable for receiving a sample comprising amplified target nucleic acids (see ¶ 0136 for example).
14. The fluidic test cassette of claim 13, wherein the detection particles are in the sample receiving chamber (see ¶ 0136 for example).
15. The fluidic test cassette of claim 1, further comprising: a heat source (e.g., 70) facing the at least one of the plurality of vent pockets (see i.e., heat source 70, which preferably comprises a resistor, on printed circuit board or PCA 75 is placed in register with vent pockets 50, 54 ¶ 0126); and a heat stable material (e.g., 72) disposed between the heat source and the heat labile material to form a hermetic barrier (see i.e., A heat stable material (such as polyimide) 72 is preferably disposed between heat source 70 and heat labile vent pocket seal material 80 to form a hermetic barrier. In some embodiments the sealed space 55 between or surrounding vent pockets is augmented by the inclusion of an optional gasket or spacer 56 comprising an adhesive layer that bonds heat stable material 72 to heat labile material 80 and/or fluidic component 5 and maintains a hermetic seal of the test cassette ¶ 0126).
16. The fluidic test cassette of claim 15, further comprising a flexible circuit comprising a metallic electrical component (i.e., resistive heating elements, conductive traces; flex circuit comprising metallic traces forming heating elements) disposed on the heat stable material (¶ 0096, 0127+).
17. The fluidic test cassette of claim 16, wherein the metallic electrical component comprises a resistive heating element (see ¶ 0011, 0096+).
18. The fluidic test cassette of claim 17, wherein the resistive heating element is aligned with the plurality of vent pockets and the plurality of chambers (see ¶ 0011+).
19. The fluidic test cassette of claim 16, wherein the metallic electrical component comprises a conductive trace (see ¶ 0011, 0127+).
20. The fluidic test cassette of claim 1, further comprising one or more temperature sensors configured to adjust at least one of a heating temperature, a heating time, and a heating rate of one or more of the plurality of chambers (see ¶ 0011 for example).
21. The fluidic test cassette of claim 1, wherein the first chamber (e.g., 5006) is different from the second chamber (e.g., 5011; see Fig. 38 for example).
Annotated Fig. 38 of Nowakowski et al. (US 2016/0310948)
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Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nowakowski et al. (US 2016/0310948).
Regarding claims 3-4, Nowakowski et al. teach: 3. The fluidic test cassette of claim 1, wherein a first side of the first projection extends substantially vertically adjacent to an inlet of the first chamber (see annotated Fig. 38; see also a side adjacent to the inlet channel 4002 in Fig. 39 & 4402 in Fig. 43 for example), and a second side (see annotated Fig. 38) of the projection extends upward toward a top of the at first chamber at an angle approximately 90 degrees from the first side extending substantially vertically (see annotated Fig. 38).
Nowakowski et al. further teach: The shape of the fluidic chambers may be selected ... to provide favorable geometries for solution ingress and egress. ¶ 0142. However, Nowakowski et al. do not explicitly teach: a second side of the projection extends upward toward a top of the at first chamber at an angle less than approximately 60 degrees from the first side extending substantially vertically. 4. The fluidic test cassette of claim 3, wherein the angle is less than between 30 degrees to degrees from vertical.
It would have been obvious to one of ordinary skill in the art at the lime the invention was made to modify Nowakowski et al. to incorporate a second side of the projection extends upward toward a top of the at first chamber at an angle less than approximately 60 degrees from the first side extending substantially vertically; wherein the angle is less than between 30 degrees to 45 degrees from vertical, since a change in shape of an element involves only routine skill in the art. The motivation for doing so would be to provide favorable reaction chamber geometries for solution ingress and egress (Nowakowski et al. ¶ 0142).
Regarding claims 5-7, modified Nowakowski et al. teach:
5. The fluidic test cassette of claim 3, further comprising a recess (e.g., reagent recess 15) capable of containing at least one lyophilized or dried reagent, the recess disposed in a channel connected to the inlet of the first chamber (see i.e., The sample input chamber preferably comprises a conduit to the expansion chamber, a sample input orifice where a nucleic acid containing sample may be added, a first recess wherein dried materials may be placed during manufacture for mixing with the input sample ¶ 0097; Reagent recess 15 is preferably situated along the inlet channel such that fluid passes through the recess to commingle with dried or lyophilized reagents contained therein prior to entering the first chamber 30. ¶ 0124; first lyophilized bead 5004 ¶ 0152).
6. The fluidic test cassette of claim 5, wherein the recess comprises one or more structures (e.g., 7001, 7004) capable of directing fluids to facilitate rehydration of the at least one dried or lyophilized reagent (see i.e., The disposable platform preferably comprises recesses along channels between chambers to accommodate the incorporation of dried or lyophilized reagents into the disposable platform. These recesses may optionally comprise structures on one or more of the surfaces facing the reagent(s) to assist with directing fluids, preferably using capillarity or surface tension effects, to the enclosed dried reagents to facilitate rehydration of the dried reagents. Such features may comprise ridges, such as ridge 7001 of FIG. 44, grooves, dimples or other structures to direct fluids to the internal space of the recess as the fluid passes through the recess, or otherwise assist in fluid flow to the internal space of the recess during fluid flow. Alternatively, a recess may be directly located within one (or more) of the chambers. ¶ 0088).
7. The fluidic test cassette of claim 6, wherein the structures comprise ridges, grooves, dimples, or combinations thereof (see i.e., Such features may comprise ridges, such as ridge 7001 of FIG. 44, grooves, dimples or other structures ¶ 0088).
Response to Arguments
Applicant's arguments filed 05/15/2026 have been fully considered but they are not persuasive.
The objection to the Drawings has been revised.
The amendments have been considered and the 35 USC § 112 rejections have been revised.
In response to the Applicant's argument that Nowakowski et al. fail to teach: “a plurality of chambers comprising at least a first chamber and a second chamber, wherein the first chamber includes a first projection extending downward into the first chamber, and the second chamber includes a second projection formed proximate an outlet and disposed orthogonally to a direction of fluid flow.”, Examiner disagrees.
Nowakowski et al. teach, among other things, a plurality of chambers (¶ 0010+) comprising at least a first chamber (e.g., reaction chamber 4003, 5006) and a second chamber (e.g., reaction chamber 4003, 5011), wherein: the first chamber includes a first projection extending downward into the first chamber (see annotated Fig. 38 for example); and the second chamber includes a second projection formed proximal an outlet (see annotated Fig. 38 for example) and capable of being disposed orthogonally to a direction of fluid flow, thereby preventing fluid from flowing directly into the outlet (see Figs. 38-42 & ¶ 0014-0015).
Applicant is encouraged to amend the claims to include additional structural elements of the fluidic test cassette.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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