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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/6/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments and remarks, filed on 6/6/2024, has been entered. The claim amendments do not overcome the prior art, and the previous prior art rejection stands.
Claim Status
Claims 1-3, 5-9, and 23 are pending and being examined.
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 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.
Claim(s) 1-3, 5-9, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wernerehl et al (US 20210031183 A1; hereinafter “Wernerehl”; priority filed 5/23/2018; already of record) in view of Andeshmand et al (US 20210047678 A1; hereinafter “Andeshmand”; priority filed on 8/15/2019; already of record).
Regarding claim 1, Wernerehl teaches a system (Wernerehl; Abstract; system for evacuating and for filling an array at the point of use), comprising:
(i) a cartridge (Wernerehl; Fig. 11A; para [295]; reaction container 1102) comprised of:
a plurality of chambers (Wernerehl; Fig. 11A; para [14, 295]; blister (e.g., a fluid reservoir)… blisters, the second-stage array, reagent wells or blisters; examiner interprets the plurality of chambers to comprise the blisters, array, and reagent wells), wherein the plurality of chambers comprises an extraction chamber (Wernerehl; Fig. 1; para [296]; lysis zone 1105 where cells and viruses in the sample can be lysed to free their nucleic acids) and a detection chamber (Wernerehl; Fig. 1; para [296]; a reaction zone 1106 where various method steps can be performed such as, but not limited to, nucleic acid recovery and purification, first-stage multiplex PCR, and preparation of first-stage product for second-stage PCR);
a plurality of reagent canisters, each reagent canister in the plurality comprising a reagent (Wernerehl; Fig. 11A; para [297]; a number of reagent blisters 1107 a-1107 d that can be used to provide reagents for assays run in the reaction container),
(ii) a plurality of magnetic particles which once introduced into the extraction chamber are retained therein (Wernerehl; para [304]; In one example, the one or more method steps or reactions in a first reaction zone may include, but are not limited to, sample lysis (e.g., by bead beating), isolation of lysis particles from the lysate, moving the lysate to another chamber in the reaction container, mixing silica magnetic beads with the lysate);
(iii) an instrument configured to receive the cartridge (Wernerehl; para [126]; introducing a sample into the sample introduction zone, inserting the reaction container into an instrument), the instrument comprising:
a first sonicator movable in at least one of the x-y-z coordinates (Wernerehl; para [298]; instrument 1101 may include a lysis apparatus (e.g., a bead beater like element 804 of FIG. 2, a paddle bead beater, a sonicator, etc.) for performing cell lysis in one or more portions of reaction container 1102; examiner notes that the sonicator is capable of moving in one of the three listed dimensions when in use);
a magnetic field positioned to capture the plurality of magnetic particles in the extraction chamber (Wernerehl; para [298]; instrument 1101 may include a magnet for magnetic bead capture); and
an optical unit for illumination of the detection chamber and for detection of signal therefrom (Wernerehl; para [298]; instrument 1101 may light source(s) and image capture systems for optical (e.g., fluorescent) excitation and data collection from one or more portions of the reaction container 1102).
Wernerehl does not teach wherein all or a portion of the plurality of reagent canisters is in fluid communication with a dedicated gas source.
However, Andeshmand teaches an analogous of a system for point-of-care nucleic acid amplification and detection (Andeshmand; Abstract) comprising a cartridge (Andeshmand; Fig. 92; para [213]; cartridge 1000) further comprising: a plurality of reagent canisters (Andeshmand; para [390]; reagent reservoirs, are formed within the fluidics card to for on-board storage of liquid substances, such as a wash buffer and an elution buffer) is in fluid communication with a dedicated gas source (Andeshmand; para [313]; one or more fluidic channels may specifically be pneumatic channels, wherein only pressurized air or gas is permitted to flow). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the plurality of reagent canisters of Wernerehl to be in fluid communication with the dedicated gas source as taught by Andeshmand, because Andeshmand teaches the pneumatic channels vent and reroute air or gas within the cartridge to permit flow (Andeshmand; para [313]).
Regarding claim 2, modified Wernerehl teaches the system of claim 1, wherein a portion of the plurality of reagent canisters are in fluid communication with the extraction chamber (Wernerehl; para [297]; a number of channels 1109 a-1109 g used to connect the zones of the reaction container).
Regarding claim 3, modified Wernerehl teaches the system of claim 1, wherein the reagent in a portion of the plurality of reagent canisters is a liquid reagent (Wernerehl; para [297]; The reagent blisters can contain dry reagents, liquid reagents, or a combination of both).
Regarding claim 5, modified Wernerehl teaches the system of claim 1, with the plurality of reagent canisters.
Wernerehl does not teach wherein one or more reagent canisters in the plurality of reagent canisters includes a frangible membrane and a piercing element.
However, Andeshmand teaches an analogous of a system for point-of-care nucleic acid amplification and detection (Andeshmand; Abstract) comprising a cartridge (Andeshmand; Fig. 92; para [213]; cartridge 1000) further comprising: one or more reagent canisters in a plurality of reagent canisters (Andeshmand; para [390]; reagent reservoirs, are formed within the fluidics card to for on-board storage of liquid substances, such as a wash buffer and an elution buffer) includes a frangible membrane and a piercing element (Andeshmand; Fig. 93; para [395]; The frangible seals 1201-1207 are ruptured with pins in the instrument). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the reagent canister of Wernerehl to comprise the frangible membrane and the piercing element as taught by Andeshmand, because Andeshmand teaches that the rupture of the seals allows fluids to flow freely through the cartridge (Andeshmand; para [395]).
Regarding claim 6, modified Wernerehl teaches the system of claim 5 (the reagent canister of Wernerehl is modified to comprise the frangible membrane and the piercing element as taught by Andeshmand), wherein the piercing element includes a hollow conduit (Andeshmand; para [395]; the fluidic channels are no longer physically blocked and fluids within the cartridge are free to flow when exposed to a motive force). Examiner notes that the fluidic channels are interpreted as part of the piercing element as the pins rupture the seal, thus exposing the channel.
Regarding claim 7, modified Wernerehl teaches the system of claim 6 (the reagent canister of Wernerehl is modified to comprise the frangible membrane and the piercing element as taught by Andeshmand), wherein gas from a dedicated gas source is movable from the gas source to a reagent canister via the hollow conduit (Andeshmand; para [313, 395]; pneumatic channels, wherein only pressurized air or gas is permitted to flow… fluidic channels are no longer physically blocked and fluids within the cartridge are free to flow when exposed to a motive force). Examiner notes that the channels interpreted as the hollow conduits are exposed to the gases upon rupture of the film.
Regarding claim 8, modified Wernerehl teaches the system of claim 1, wherein each reagent canister interacts with an actuator in the instrument (Wernerehl; para [298]; instrument 1101 may include actuators for moving fluids within one or more portions of the reaction container 1102).
Regarding claim 9, modified Wernerehl teaches the system of claim 8, wherein each reagent canister interacts with a dedicated actuator (Wernerehl; para [213]; actuator elements positioned over each of the blisters and channels).
Regarding claim 23, modified Wernerehl teaches the system of claim 1, wherein the reagent is a reagent for amplification and detection of a nucleic acid (Wernerehl; para [202]; the reagents are for nucleic acid extraction, first-stage multiplex PCR, dilution of the multiplex reaction, and preparation of second-stage PCR reagents, as well as control reactions).
Response to Arguments
Applicant’s arguments filed, 6/6/2025, have been fully considered. The arguments are not found to be persuasive, and the non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page 4-5, the Applicant argues that that Wernerehl does not disclose the cartridge assembly. Specifically, Applicant argues that the “reagent canister” of Wernerehl is structurally different/not analogous to claimed canister and emphasizes paragraphs [0015]-[0019] of the prior art. The examiner respectfully disagrees. The Applicant argues that a person of ordinary skill in the art would not have understood the description of card-like structures having wells and channels correspond to the claimed cartridge containing canisters. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 recites “a plurality of reagent canisters, each reagent canister in the plurality comprising a reagent”. The broadest reasonable interpretation of a reagent canister is a container/holder comprising a reagent. Thus, Wernerehl in view of Andeshmand teaches all of the structural claim limitations.
In the Applicant’s arguments, on page 6, the Applicant argues Wernerehl in view of Andeshmand fail to teach the sonicator movable in at least one of an x, y, or z direction. The examiner respectfully disagrees. The Applicant points out that Wernerehl does teach the sonicator in the instrument. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, a user is capable of moving the entire instrument and would therefore read on the sonicator being movable. Additionally, the Applicant notes that the sonicator disclosed by Wernerehl only mentions it in passing as an alternative with no guidance as to how one should be configured or implemented. The sonicator as claimed does not provide guidance as to how the structure relates to the cartridge. The Applicant’s claim an instrument which comprises a sonicator, all of which is disclosed by Wernerehl.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796