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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 20-31 in the reply filed on 05/19/2026 is acknowledged.
Claims 32-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/19/2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15547875, filed on 08/01/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/30/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 132a-c and 132 (mentioned in section “1.3.4 Blister sub-assembly”, wherein “Figure 5 shows the blister sub-assembly”; however these reference signs could not be located in Fig. 5). 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. 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 § 102
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.
Claims 20-23, 25, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Battrell et al. (US Patent Application Publication 2009/0148933) (already of record).
Regarding claim 20, Battrell et al. discloses a fluidic cartridge for performing a diagnostic test on a sample (Abstract, para. 208), the fluidic cartridge comprising:
a front end (left end of device as shown in Figs. 1-4, sheets 1-4 of 28) configured to prepare the sample for analysis by separating nucleic acids from the sample (see preparation steps including separating nucleic acids from the sample as discussed in para. 174-181; elements for performing these steps are included on the left side of the device as shown in Figs. 1-4), the front end comprising: a sample inlet (para. 174) (Figs. 1-4), a lysis blister (para. 213, 237, 360) (Figs. 1-4), a mixing chamber (called lysis chamber) (para. 177, 180, 363) (Figs. 1-4), a wash buffer blister (para. 182, 360) (Figs. 1-4), an elution buffer blister (para. 183, 360) (Figs. 1-4), a capture column (called depth filter) (para. 177, 363) (Figs. 1-4) and an elution chamber (called nucleic acid target capture chamber, wherein elution buffer is introduced) (para. 183, 223) (Figs. 1-4);
a back end (right end of device as shown in Figs. 1-4) configured to analyze the nucleic acids of the sample (see elements for PCR amplification and detection which are provided on the right side of the device, para. 188-198 and Figs. 1-4), the back end comprising: an amplification chamber (para. 190-196) (Figs. 1-4) and a detection chamber (para. 201) (Figs. 1-4);
an isolation valve (valve provided between nucleic acid target chamber and amplification chamber; reads on an isolation valve as it serves to control, or isolate, fluid flow) (para. 190, 216) (Figs. 1-4) comprising a valve chamber with a first opening fluidly connected to the front end and a second opening fluidly connected to the back end (para. 240-241) (Figs. 7-8, sheets 7-8 of 28); and
a flexible membrane overlying the valve chamber (para. 240-241) (Fig. 7), the membrane moveable from an open position spaced apart from the openings to a closed position sealing at least one of the openings by an actuator (para. 240-241) (Fig. 7).
Regarding claim 21, Battrell et al. discloses wherein the valve chamber is formed by a recess in a fluidic layer comprising the front end and the back end (para. 240-241) (Figs. 7-8).
Regarding claim 22, Battrell et al. discloses wherein at least one of the first opening or the second opening is on a raised portion of the valve chamber which forms a valve seat (para. 240-241) (Fig. 7).
Regarding claim 23, Battrell et al. discloses wherein the flexible membrane comprises a deformable polymer (para. 240-241) (Fig. 7).
Regarding claim 25, Battrell et al. discloses wherein when the membrane is in the closed position, the back end is a closed system (the entire device is disclosed to be a “closed device”, see para. 185, and thus closing the membrane of the valve, which separates the front end and the back end as discussed in the rejection of claim 20, above, would necessarily lead to the back end being a closed system).
Regarding claim 31, the entirety of the claim is directed to a further structural limitation of the actuator; however, the actuator is not a positively recited structural element of the claimed fluidic cartridge. Therefore, the claim does not introduce a patentable distinction over the prior art.
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.
Claims 24 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell et al. (US Patent Application Publication 2009/0148933) (already of record) in view of Colin et al. (US Patent 6,929,239).
Regarding claim 24, Battrell et al. discloses wherein the membrane is in the open position when pulled up by a vacuum (para. 240).
Battrell et al. is silent as to wherein the membrane is biased in the open position.
Colin et al. discloses a microfluidic card device (cartridge) (col. 6 lines 19-44, claim 1) comprising a valve for controlling fluid flow through a path (col. 6 lines 45-52), the valve comprising a flexible membrane movable from an open position to a closed position (col. 6 lines 45-60). The membrane is in the open position by default and moves the closed position under the action of an actuator comprising a piston (col. 6 line 45-col. 7 line 21) (Figs. 2-3); thus, the membrane is biased in the open position. Colin et al. further discloses that this configuration is advantageous as it does not require external and continuous intervention to control the valve (col. 2 lines 58-65, col. 7 lines 9-12).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the membrane of the valve disclosed by Battrell et al. to be biased into the open position, e.g., by adopting the valve configuration disclosed by Colin et al., in order to advantageously control the valve position without continuous intervention.
Regarding claim 26, Battrell et al. discloses the isolation valve comprising the membrane moveable between the open position and the closed position by means of the actuator, as set forth above.
Battrell et al. is silent as to wherein the isolation valve comprises a latching mechanism configured to prevent the actuator from retracting once the actuator has moved the membrane to the closed position.
Colin et al. discloses a microfluidic card device (cartridge) (col. 6 lines 19-44, claim 1) comprising a valve for controlling fluid flow through a path (col. 6 lines 45-52), the valve comprising a flexible membrane movable from an open position to a closed position by an actuator (col. 6 lines 45-62). The valve further comprises a latching mechanism (comprising beveled surface 12) configured to prevent the actuator from retracting once the actuator has moved the membrane to the closed position (col. 6 line 45-col. 7 line 12) (Figs. 2-3, sheet 1 of 7). Colin et al. further discloses that this configuration is advantageous as it does not require external and continuous intervention to control the valve (col. 2 lines 58-65, col. 7 lines 9-12).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the isolation valve disclosed by Battrell et al. to comprise a latching mechanism configured to prevent the actuator from retracting once the actuator has moved the membrane to the closed position, e.g., by adopting the valve configuration disclosed by Colin et al., in order to advantageously control the valve position without continuous intervention.
Regarding claim 27, Battrell et al. in view of Colin et al. teaches the latching mechanism, as set forth in the rejection of claim 26, above, wherein Colin et al. further discloses that the latching mechanism comprises at least one latching arm with a latching projection, the latching arm configured to engage the latching projection with a latching surface connected to the actuator (see beveled surface 12 at upper end of arm, col. 6 line 45-col. 7 line 12 and Figs. 2-3). Therefore, the prior art combination arrives at the claimed subject matter.
Regarding claim 28, Battrell et al. in view of Colin et al. teaches a beveled surface of the latching projection, as set forth above, and Colin et al. further discloses that the beveled surface of the latching projection is configured to be contacted, displaced, and passed by a beveled surface (15) of a latching surface of the actuator (col. 6 line 45-col. 7 line 12) (Figs. 2-3). Therefore, the prior art combination arrives at the claimed subject matter.
Regarding claim 29, Battrell et al. in view of Colin et al. teaches the latching mechanism, as set forth in the rejection of claim 26, above, wherein Colin et al. further discloses that the latching mechanism comprises a latching arm with a corresponding latching surface (see beveled surface 12 at upper end of arm, col. 6 line 45-col. 7 line 12 and Figs. 2-3).
The prior art combination is silent as to two diametrically opposed latching arms and two corresponding latching surfaces.
Nonetheless, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04). Modifying the prior art combination so as to comprise two diametrically opposed latching arms and two corresponding latching surfaces would require mere duplication of the latching arm and corresponding latching surface already disclosed by the prior art, and would yield the predictable result of enhancing stability of the closed valve position.
Regarding claim 30, the entirety of the claim is directed to a further structural limitation of the actuator; however, the actuator is not a positively recited structural element of the claimed fluidic cartridge. Therefore, the claim does not introduce a patentable distinction over the prior art.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Liu et al. (US Patent Application Publication 2008/0017306) is directed to a microfluidic diagnostic device comprising latching mechanism configured to maintain a valve in a closed position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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