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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/8/2026 has been entered.
Response to Amendment
The Amendment filed on 1/8/2026 has been entered. Claims 1 and 3-12 remain pending in the application.
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 and 3-12 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 recites “a stage constructed to mount a single one of a plurality of detachable substrates …wherein the plurality of detachable substrates comprises a first substrate and a second substrate.” This recitation is worded that the plurality of detachable substrates are not positively claimed. However, the claim later tries to further limit the first and second substrates with several limitations, thereby seeming to want the first and second substrates positively recited. For examination purposes, they are interpreted not to be positively recited. Claims 3-12 are rejected by virtue of their dependence on a rejected base claim. If the applicant wishes to positively recite the substrates the examiner suggests to amend the claim so that it states:
“A nucleic acid analyzer comprising:
a plurality of detachable substates,
a stage constructed to mount a single one of [[a]]the plurality of detachable substrates each having a different size in terms of a number of flow paths and each including a reaction field for analyzing a nucleic acid,
wherein the plurality of detachable substrates comprises a first substrate and a second substrate…”
Claim 4 recites “a first groove” in line 2 and claim 1 recites “a first groove.” However, this is unclear if the first groove recited in claim 4 is the same or different than the first groove recited in claim 1. For examination purposes, they are interpreted to be the same.
Claim 5 recites “a first groove” in line 3 and claim 1 recites “a first groove.” However, this is unclear if the first groove recited in claim 5 is the same or different than the first groove recited in claim 1. For examination purposes, they are interpreted to be the same.
Claim 5 recites “a second groove” in line 5 and claim 1 recites “a second groove.” However, this is unclear if the second groove recited in claim 5 is the same or different than the second groove recited in claim 1. For examination purposes, they are interpreted to be the same.
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.
Claim(s) 1- is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2011/0072914, hereinafter Lebl in view of United States Application Publication No. 2013/0017538, hereinafter Ionescu.
Regarding claim 1, Lebl teaches a nucleic acid analyzer (figure 1) comprising: a stage (item 806) constructed to mount a single one of a plurality of detachable substrates each having a different size in terms of a number of flow paths and each including a reaction field for analyzing a nucleic acid the examiner notes that the plurality of substrate is not positively claimed (MPEP § 2115) and therefore limitations regarding the plurality of substrates have minimal patentable weight, further, Lebl teaches the ability of the stage to mount a substrate (item 802)), wherein the plurality of detachable substrates comprises a first substrate and a second substrate (the detachable substrates are not positively claimed (MPEP § 2115) and is further taught in figure 9), wherein the stage comprises; a single introduction path (item 812) through which a reagent to be introduced into a mounted one of the plurality of detachable substrates is conveyed (paragraph [0057]); a first discharge path (one of the channels in item 825) to receive the reagent discharged from the mounted substrate (paragraph [0058]); a second discharge path (another one of the channels in 825) to receive the reagent discharged from the mounted substrate (paragraph [0058]); a reagent selection mechanism (item 1120) configured to select the reagent to be introduced into the mounted substrate (paragraph [0075]); an aspiration mechanism (item 1130) configured to aspirate the reagent from upstream sides of the first discharge path and the second discharge path to introduce the reagent into the mounted substrate via the introduction path (paragraph [0036]); and a first groove (the openings in the subassembly 800 which allows for the vacuum, paragraph [0057]) formed on a surface of the stage.
Lebl fails to teach a second groove located on a surface of the stage.
Ionescu teaches a device for holding substrates in which a number of vacuum chucks is utilized in order to seal the removable substrates (Ionescu, paragraph [0093]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a second groove below the first substrate because it would improve the sealing with the removable substrates (Ionescu, paragraph [0093]).
As described above, the plurality of detachable substrates (and therefore the first and second substrates) are not positively recited (MPEP § 2115) and therefore limitations regarding the plurality of detachable substrates have minimal patentable weight. Therefore, the limitations regarding that the mounted substrates (not positively recited from the plurality of substrates) being a first substrate with a first size and a second substrates having a second different size from the first size and then all of the limitations as to what the first and second substrates have are all regarding a structures which are not positively recited and therefore all of these structures have minimal patentable weight. The device of Lebl would be capable of mounting a first or second substrate as described in the claims and can be seen in figure 9 of Lebl.
Regarding claim 3, Lebl teaches a connection flow path (the flow paths connecting items 1102-1105 to 1120 to 1124) configured to connect a reagent container containing the reagent to the introduction path (figure 19), wherein the connection flow path does not branch in a path from the reagent container to the introduction path (figure 19).
Regarding claim 4, Lebl teaches a first groove (the openings in the subassembly 800 which allows for the vacuum, paragraph [0057]) located below the first substrate when the first substrate is attached to the nucleic acid analyzer (paragraph [0057]); and a first pump (paragraph [0057]) configured to aspirate the first substrate via the first groove (paragraph [0057]), wherein the first pump fixes the first substrate to the nucleic acid analyzer by aspirating the first substrate via the first groove (paragraph [0057]).
Regarding claim 6, the second substrate is not positively claimed and therefore any limitation on the second substrate has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Lebl.
Regarding claim 7, Lebl teaches an imaging mechanism (item 140) configured to image a specimen flowing through the first substrate or the second substrate (figure 1), wherein a range in which the imaging mechanism captures an image when the first substrate is mounted on the stage is larger than a range in which the imaging mechanism captures an image when the second substrate is mounted on the stage (intended use MPEP § 2114 (II) and is taught in figure 1).
Regarding claim 8, Lebl teaches wherein the aspiration mechanism includes: a first aspiration unit (one of the channel pumps of item 1130) connected to the first discharge path (figure 19); and a second aspiration unit (another of the channel pumps of item 1130) connected to the second discharge path (figure 19), the first aspiration unit aspirates the reagent via the first discharge path (figure 19), and the second aspiration unit aspirates the reagent via the second discharge path to introduce the reagent into the first substrate (figure 19), and the first aspiration unit aspirates the reagent via the first discharge path to introduce the reagent into the second substrate (figure 19).
Regarding claim 10, Lebl teaches wherein the reagent selection mechanism includes: a first branch path (the path between items 1102 and 1120) connected to a first reagent container containing a first reagent (figure 19); a second branch path (the path between items 1103 and 1120) connected to a second reagent container containing a second reagent (figure 19); a merging point at which the first branch path and the second branch path merge (item 1120); and a flow path configured to connect the merging point and the inlet portion (the path connection items 1120 and 1124).
Regarding claim 12, modified Lebl teaches wherein the number of paths configured to coney the reagent discharged from the first substrate is larger than the number of introduction paths (see supra).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lebl and Ionescu as applied to claim 1 above, and further in view of WO 2009/010970 A2, hereinafter Pinchas.
Regarding claim 5, Lebl teaches a first groove (the openings in the subassembly 800 which allows for the vacuum, paragraph [0057]) located below the first substrate when the first substrate is mounted on the stage (paragraph [0057]); a first pump (paragraph [0057]) configured to aspirate the first substrate via the first groove (paragraph [0057]).
Modified Lebl teaches a second groove located below the first substrate when the first substrate is mounted on the stage (see supra).
Lebl and Ionescu fail to teach a second pump configured to aspirate the first substrate via the second groove.
Pinchas teaches a device with an additional pump which can be used as a backup for the other pumps (Pinchase, page 16, lines 10-12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a second pump to the device because it would operate as a backup pump for the other pumps (Pinchase, page 16, lines 10-12).
Modified Lebl teaches wherein the first substrate has a shape and a planar size such that both the first groove and the second groove are covered with the first substrate when the first substrate is mounted on the stage (see supra), the first pump and the second pump fix the first substrate to the nucleic acid analyzer by aspirating the first substrate via the first groove and the second groove, respectively (see supra), and the first pump fixes the second substrate to the nucleic acid analyzer by aspirating the second substrate via the first groove (see supra).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lebl and Ionescu as applied to claim 1 above, and further in view of United States Application Publication No. 2017/0191924, hereinafter Pristinski.
Regarding claim 9, Lebl teaches wherein the aspiration mechanism includes: an aspiration unit (item 1130) connected to the first discharge path and the second discharge path (figure 19).
Lebl and Ionescu fail to teach a first valve configured to block or open the first discharge path; and a second valve configured to block or open the second discharge path, the first valve opens the first discharge path, the second valve blocks the second discharge path, and the aspiration unit aspirates the reagent to introduce the reagent into the first flow path, the first valve blocks the first discharge path, the second valve opens the second discharge path, and the aspiration unit aspirates the reagent to introduce the reagent into the second flow path, and one of the first valve and the second valve is opened while the other valve is blocked, and the aspiration unit aspirates the reagent to introduce the reagent into the third flow path.
Pristinski teaches one or more valves are located in the fluid path between the pump and the channel so that fluid communication between the pump and the channel can occur (Pristinski, paragraph [0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added valves between the aspiration unit and the first and second discharge because it would allow for fluid communication between the pump and the channel can occur (Pristinski, paragraph [0031]).
Regarding how the first and second valves are controlled, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Lebl, Ionescu and Pritinski and the apparatus of modified Lebl is capable of controlling the first and second valve as claimed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lebl (see MPEP §2114).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lebl and Ionescu as applied to claim 10 above, and further in view of United States Application Publication No. 2015/0276692, hereinafter Olson.
Regarding claim 11, Lebl teaches wherein the reagent selection mechanism includes: a multi-valve valve (item 1120) configured to block or open a flow path between the first branch path and the first reagent container (figure 19); and configured to block or open a flow path between the second branch path and the second reagent container (figure 19), the reagent selection mechanism selects the first reagent by opening and blocking ports of the valve (figure 19), and the reagent selection mechanism selects the second reagent by opening and blocking ports of the valve (figure 19).
Lebl and Ionescu fail to teach a third and fourth valve to block or open flow paths between containers and the rest of the device.
Olson teaches a device with multiple valves or a multi-way valve to control the flow through the device (Olson, paragraph [0049]).
Examiner further finds that the prior art contained a device/method/product (i.e., multiple valves) which differed from the claimed device by the substitution of component(s) (i.e., a multi-way valve) with other component(s) (i.e., multiple valves), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., multi-way valve with multiple valves), and the results of the substitution (i.e., controlling the flow) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute a multi-way valve of reference Lebl with multiple valves of reference Olson, since the result would have been predictable.
Response to Arguments
The examiner notes that claim 1 is currently phrased “a stage constructed to mount a single one of a plurality of detachable substrates.” This is therefore interpreted so that only one of the detachable substrates needs to be able to mount to the stage and the other of the substrates just needs to exist with no requirement for it to connect to the stage. From applicant’s arguments and specification, it appears that applicant wants to have each of the plurality of substrates being able to be mounted to the stage. The examiner suggests to instead recite a stage constructed to mount each of the plurality of detachable substrates, one at a time or similar language to this so that it is clear that each of the detachable substrates need to be able to be mounted to the stage.
Applicant's arguments filed 1/8/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the claim 1 now positively recites the plurality of detachable substrates with the limitation “wherein the plurality of detachable substrates comprises a first substrate and second substrate” and “wherein the second substrate is mounted on the stage.” Is not found persuasive. The claim starts out as reciting that the “stage is constructed to mount a single one of a plurality of detachable substrates.” This recitation is therefore stating that the stage is constructed to mount the substrates, but does not positively recite them. The two limitations the applicant points to, just further limit the substrates, but still does not positively recite them. Please see the 112(b) rejection above for claim language to positively recite the substrates.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796