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 because numerous reference numbers and descriptive text labels are illegible. 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.
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.
Claims 1-20 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 1 is vague and unclear reciting “a plurality of chambers, wherein at least one chamber includes a projection extending downward into the chamber”, because it is unclear if the at least one chamber is of the plurality of chambers, or another chamber. For this reason “a feature formed in at least one of the plurality of chambers” is also unclear if the limitation is referring to the at least one chamber. For the reasons above, dependent claims relating to these recitations are similarly unclear.
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2 and 8-20 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+), wherein at least one chamber includes a projection (see i.e., a downward projection element adjacent to the inlet channel 4002 in Fig. 39; see also triangular flow control feature 4001 in Fig. 39 & ¶ 0157 for example) extending downward into the chamber (see Figs. 39-43 for example);
a feature (e.g., 7001, 7004) formed in at least one of the plurality of chambers (see ¶ 0088, 0127 & Figs. 44, 45 for example); said feature formed proximal an outlet (see ¶ 0088, 0127 & Figs. 44, 45 for example) and capable of being disposed orthogonally to a direction of fluid flow (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 & Figs. 44-45 for example);
a plurality of vent pockets (e.g., first vent pocket, second vent pocket) connected to each of a corresponding chamber (¶ 0088+); and
a heat labile material for sealing at least one of the plurality of vent pockets (¶ 0088+).
Regarding claims 2 and 8-20, Nowakowski et al. teach:
2. The fluidic test cassette of claim 1, wherein the projection is generally triangular in shape (see Fig. 39, ¶ 0014+ for example).
8. The fluidic test cassette of claim 1, wherein the feature formed in at least one of the plurality of chambers is triangular or trapezoidal in shape (see ¶ 0014+ for example).
9. The fluidic test cassette of claim 1, wherein the feature formed in at least one of the plurality of chambers forms a tapered outlet (e.g., 4005 see ¶ 0081, 0157 & Fig. 39).
10. The fluidic test cassette of claim 1, wherein a channel (e.g., 4306) located downstream of the outlet comprises turns (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).
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).
13. The fluidic test cassette of claim 11, wherein the detection chamber comprises 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).
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 capable of adjusting 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).
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.
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 projection extends substantially vertically adjacent to an inlet (i.e., a proximal side adjacent to the inlet channel 4002) of the at least one chamber, and a second side of the projection extends upward toward a top of the at least one chamber (i.e., a distal side) at an angle from the first side extending substantially vertically (see Fig. 39 for example). However, Nowakowski et al. do not explicitly teach: a second side of the projection extends upward toward a top of the at least one 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 a second side of the projection extends upward toward a top of the at least one 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 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 at least one 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).
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).
Conclusion
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