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 .
Applicant’s filing of claims 1-20 on 5/31/24 is acknowledged. Claims 21-37 were canceled. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/29/24 and 6/25/24 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
Claim Rejections - 35 USC § 103
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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al. (“Handique’524,” US Pub. No. 2020/0325524) in view of Handique et al. (“Handique’609,” US Pub. No. 2021/0087609).
As to claims 1 and 18, Handique’524 discloses a microfluidic cartridge in fig. 10B, for example, comprising: an inlet (e.g., sample inlet); a reaction chamber (e.g., reactor); a vent (e.g., vent); a fill channel (between sample inlet and reactor) between spanning between the inlet and the reaction chamber comprising a first lower channel, a first through channel, and a first upper channel (see parts of channel in figs. 9 et seq.); a vent channel (between reactor and vent) spanning between the reaction chamber and the vent comprising a second upper channel, a second through channel, and a second lower channel (see parts of channel in figs. 9 et seq.); and a valve (e.g., microvalves). While Handique’524 discloses different types of valves in e.g., [0126] et seq., Handique’524 does not specifically disclose the valve is configured to simultaneously seal the fill channel and the vent channel along the first lower channel and the second lower channel. Handique’609 discloses in e.g., [0147], sample material passes along channel 308 to enrichment region 302. The fluid travels into the concentration region (including a circular filter whose center is typically free and whose edge 309 is secured to the chip) and through the filter leaving the cells or other particles of interest behind at an internal surface of the filter. The waste fluid, may pool on top of the device, and can be discarded, assuming a thin meniscus of liquid remains on the top of the filter to prevent drying and to provide a reservoir from which to backflow. Once the cells are trapped by the filter, the user actuates the valve 310, thus obstructing the passage of material between port 304 and enrichment region 302. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to simultaneously seal the fill and vent channels because it would increase analysis efficiency.
As to claims 2 and 3, the combination of Handique’524 and Handique’609 disclose the reaction chamber is conical or trapezoidal. See e.g., [0136] et seq. of Handique’524.
As to claims 4 and 5, the combination of Handique’524 and Handique’609 disclose the claimed volume of the reaction chamber in e.g., [0060] et seq. of Handique’524.
As to claim 6, the combination of Handique’524 and Handique’609 disclose a top layer configured to seal the reaction chamber, the first upper channel, and the second upper channel. See e.g., [0127] et seq. of Handique’524.
As to claim 7, the combination of Handique’524 and Handique’609 disclose the valve is configured to confine a fluid sample to the fill channel and the reaction chamber. See e.g., [0126] et seq. of Handique’524.
As to claims 8 and 9, the combination of Handique’524 and Handique’609 disclose a bottom layer configured to seal the first lower channel and the second lower channel; and a bottom layer configured to seal valve channels of the valve. See e.g., [0124] et seq. of Handique’524.
As to claim 10, the combination of Handique’524 and Handique’609 disclose a first valve channel forming a junction with the first lower channel and a second valve channel forming a junction with the second lower channel. See e.g., [0111 et seq. of Handique’524.
As to claim 11, the combination of Handique’524 and Handique’609 disclose an assembly for amplification and detection comprising: a cartridge in fig. 10B comprising: an inlet (sample inlet); a reaction chamber (reactor); a vent (vent); a fill channel (between sample inlet and reactor) spanning between the inlet and the reaction chamber comprising a first lower channel, a first through channel, and a first upper channel; a vent channel (between reactor and vent) spanning between the reaction chamber and the vent comprising a second upper channel, a second through channel, and a second lower channel; a valve (microvalve); a heater assembly (e.g., [0058] et seq.) configured to apply heat to the reaction chamber and the valve; and a detector (e.g., [0009] et seq.) configured to detect fluorescence from the reaction chamber. While Handique’524 discloses different types of valves in e.g., [0126] et seq., Handique’524 does not specifically disclose the valve is configured to simultaneously seal the fill channel and the vent channel along the first lower channel and the second lower channel. Handique’609 discloses in e.g., [0147], sample material passes along channel 308 to enrichment region 302. The fluid travels into the concentration region (including a circular filter whose center is typically free and whose edge 309 is secured to the chip) and through the filter leaving the cells or other particles of interest behind at an internal surface of the filter. The waste fluid, may pool on top of the device, and can be discarded, assuming a thin meniscus of liquid remains on the top of the filter to prevent drying and to provide a reservoir from which to backflow. Once the cells are trapped by the filter, the user actuates the valve 310, thus obstructing the passage of material between port 304 and enrichment region 302. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to simultaneously seal the fill and vent channels because it would increase analysis efficiency.
As to claims 12 and 13, the combination of Handique’524 and Handique’609 disclose the heater assembly comprises a conductive element configured to receive the reaction chamber; and the heater assembly is configured to heat a thermally responsive substance of the valve. See e.g., [0072] et seq.
As to claims 14-16, the combination of Handique’524 and Handique’609 disclose the detector is configured for two-color detection; the detector is configured to detect a plurality of different fluorogenic probes for syndromic testing; and the assembly is configured to receive a plurality of detectors. See e.g., [0009] et seq.
As to claim 17, the combination of Handique’524 and Handique’609 disclose the assembly is configured to receive a plurality of cartridges.. See e.g., [0009] et seq.
As to claim 19, see e.g., [0044] et seq. of Handique’524.
As to claim 20, see e.g., [0060] et seq. of Handique’524.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
9/30/2026
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