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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Various claims (e.g., claims 1, 2, 3, 10, 11, 12, 19 and 20) contain conditional language that renders the claims indefinite, since it is not clear whether or not the necessary condition has actually been met.
Claim 1 discloses “when the liquid transferring assembly is moved to the inserting position, the tip on the connecting portion is inserted into the liquid storing tank of the cartridge, and when the liquid transferring assembly is moved to the disengaging position, the tip on the connecting portion disengages from the liquid storing tank of the cartridge”. If the chamber does not move into the inserting and/or disengaging position, then the intended use does not occur and is effectively void.
Claim 2 discloses “when the toggling rod is inserted into the cartridge, the toggling rod is capable of driving the cartridge to rotate along with the rotating member”. If the toggling rod is not inserted into the cartridge, then the intended use does not occur and is effectively void.
Claim 3 discloses “when the liquid transferring assembly is moved along with the lifting base to the inserting position, the connecting portion is capable of engaging with or disengaging from the tip in the tip cavity”. If the liquid transferring assembly is not moved along with the lifting base to the inserting position, then the intended use does not occur and is effectively void.
Claim 10 discloses “when the tray is moved to the house-in position, the driving member abuts the clamping mechanism and drives the clamping mechanism to clamp the cartridge on the cartridge loading position. If the tray is not moved to the house-in position, then the intended use does not occur and is effectively void.
Claim 11 discloses “when the tray is moved to the house-in position, the driving member abuts against the clamping block, and pushes the clamping block to move toward the cartridge loading position to abut against the cartridge, and the elastic member provides a resilience force to enable the clamping block to have a tendency to move away from the cartridge loading position.”. If the tray is not moved to the house-in position, then the intended use does not occur and is effectively void.
Claim 12 discloses “when the tray is moved to the house-in position, the two clamping blocks are pushed by the two driving members correspondingly to clamp the cartridge”. If the tray is not moved to the house-in position, then the intended use does not occur and is effectively void.
Claim 19 discloses “when the reacting chamber is inserted into the liquid storage assembly, the reacting chamber liquid inlet pipe is in communication with the reacting chamber liquid inlet channel, and the reacting chamber liquid discharge pipe is in communication with the reacting chamber liquid discharge channel”. If the reacting chamber is not inserted into the liquid storage assembly, then the intended use does not occur and is effectively void.
Claim 20 discloses “when the tip on the connecting portion are inserted into the liquid storing tank, sucking the reagent in the current liquid storing tank or injecting the reagent into the current liquid storing tank through the tip”. If the tip on the connecting portion is not inserted into the liquid storing tank, then the method does not occur and is effectively void.
Claims 2-20 depend on independent claim 1 and are therefore rejected for the same reason.
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 1-6, 9-11, 13 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richards et al. (hereinafter Richards) WO 2016/161022 cited in the IDS filed 07/22/2025.
Regarding claim 1, Richards discloses device of automatically detecting nucleic acid, comprising: a fixing frame (base assembly 140) [00132]; a cartridge positioning assembly (reagent stage 500 and cassette stage 800) mounted on the fixing frame and having a cartridge loading position configured to position a cartridge [00147-00148 and 00154]; a lifting assembly comprising a lifting base (pipettor 1200) provided on the fixing frame, wherein the lifting base is configured to be controllably moved toward or away from the cartridge positioning assembly in a first direction [00162-00165]; a rotating assembly comprising a rotating member (theta-axis motor 1250) provided on the lifting base, wherein the rotating member is capable of controllably rotating relative to the lifting base around a rotation axis parallel to the first direction [00162]; and a liquid transferring assembly (fluid transfer pipette 1210) mounted on the rotating member and comprising a connecting portion (pipettor mandrel 1240) configured to connect to a tip [00162 and 00164], wherein the liquid transferring assembly is capable of rotating with the rotating member to a position where the connecting portion is aligned with any liquid storing tank of the cartridge in the first direction, the liquid transferring assembly is capable of moving along with the lifting base to an inserting position or a disengaging position in the first direction [00162-00166]. Also see whole document.
As to wherein when the liquid transferring assembly is moved to the inserting position, the tip on the connecting portion is inserted into the liquid storing tank of the cartridge, and when the liquid transferring assembly is moved to the disengaging position, the tip on the connecting portion disengages from the liquid storing tank of the cartridge, the device disclosed by Richards is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Richards is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [00162-00166]. In other words, absent evidence to the contrary, the device disclosed by Richards would be able to perform the same functions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 2, Richards discloses wherein the rotating assembly further comprises a toggling rod (tip stripper collar 1260) eccentrically mounted on a side of the rotating member facing the cartridge loading position, the toggling rod is capable of moving along with the lifting base in the first direction to a position where the toggling rod is inserted into or disengaged from the cartridge [00163].
Regarding claim 3, as to wherein the liquid transferring assembly is further capable of rotating along with the rotating member to a position where the connecting portion is aligned with a tip cavity of the cartridge in the first direction, the device disclosed by Richards is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Richards is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [00162-00166]. In other words, absent evidence to the contrary, the device disclosed by Richards would be able to perform the same functions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 4, as to wherein the lifting base passes through a first position, a second position, and a third position in sequence during moving towards the cartridge, the device disclosed by Richards is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Richards is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [00162-00162].
In other words, absent evidence to the contrary, the device disclosed by Richards would be able to perform the same functions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 5, as to wherein the liquid transferring assembly is further capable of rotating along with the rotating member to a position where the connecting portion is aligned with a plunger hole of the cartridge in the first direction, and the liquid transferring assembly is capable of moving along with the lifting base toward the cartridge along the first direction to be inserted in the plunger hole, and pushing a plunger in the plunger hole, the device disclosed by Richards is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Richards is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [00162-00162].
In other words, absent evidence to the contrary, the device disclosed by Richards would be able to perform the same functions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 6, Richards discloses wherein the lifting assembly further comprises a driving mechanism (z-axis motor 1230); the driving mechanism comprises a linear driving member mounted on the fixing frame and connected to the lifting base, the linear driving member is configured to drive the lifting base to move relative to the fixing frame along the first direction [00162 and 00164]
Regarding claim 9, Richards discloses a nucleic acid detecting module (illuminator 1400 and optics system 1450) provided on the fixing frame, wherein the nucleic acid detecting module is arranged corresponding to the cartridge and is configured to perform nucleic acid detection on nucleic acid-containing liquid formed in the cartridge [00184]. Also see Figs. 14 A and 14B
Regarding claim 10, Richards discloses wherein the cartridge positioning assembly comprises: a base (one or more bearings 1010); a tray assembly comprising a tray (cassette nest 810) provided on the base and a clamping mechanism (locating pins 814) provided on the tray, wherein the tray is configured to be controllably moved relative to the base to a house-in position and a house-out position, and the cartridge loading position is provided on the tray; and a driving member (1120 linear actuator) provided corresponding to the house-in position [00158-00159].
Regarding claim 11, Richards discloses wherein the clamping mechanism comprises a clamping block and an elastic member as shown in Fig. 8A reproduced below, the clamping block is connected to the tray and is capable of moving toward or away from the cartridge loading position, the elastic member abuts against the tray and the clamping block [00155].
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Regarding claim 13, Richards discloses wherein the cartridge positioning assembly further comprises a driving assembly (stepper motor 1020) provided on the base, and the driving assembly is capable of driving the tray to move between the house-in position and the house-out position [00159].
Regarding claim 20, Richards discloses the device of claim 1, therefore, the necessary steps must follow. See rejection of claim 1 above. Further, Richards discloses loading the cartridge on the cartridge loading position of the cartridge positioning assembly [00154-00156], wherein, each liquid storing tank of the cartridge is pre-installed with samples and various reagents for nucleic acid extraction and detection pretreatment [00146]; b, driving the liquid transferring assembly to rotate through the rotating member until the connecting portion of the liquid transferring assembly is selectively aligned with a liquid storing tank of the cartridge [00161-00166]; c, driving the liquid transferring assembly through the lifting base to enable the tip on the connecting portion to insert into or disengage from the liquid storing tank successively, and [00161-00166]; d, performing step b and step c cyclically to transfer reagent in each liquid storing tank and mixing reagents with the sample, until nucleic acid extraction and detection pretreatment are completed to obtain the nucleic acid-containing liquid; and e, performing nucleic acid detection on the nucleic acid-containing liquid [00168-00184 and 00275]. Also see [00272-00288 and 00295].
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.
Claims 7-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Richards WO 2016/161022 as applied above to claims 1-6, 9-11, 13 and 20.
Regarding claim 7, Richards discloses wherein the lifting assembly further comprises a guiding rod as shown in Fig. 13 reproduced below, the guiding rod is indirectly fixed to the fixing frame and extends in the first direction, the lifting base is slidably connected to the guiding rod; the lifting base is provided with a first sensing piece, two second photoelectric sensors configured to detect the first sensing piece are mounted on the fixing frame (The pipettor 1200 may comprise a z-contact sensor and a tip presence sensor. The z-contact sensor may indicate that the z-axis drive has moved down (negative z-direction) without a corresponding movement of the pipette arm 1270. The tip presence sensor may indicate that the tip stripper collar 1260 has been raised (positive z- direction) relative to the pipettor mandrel 1240.) [00164].
Richards does not explicitly state that the two second photoelectric sensors are arranged at intervals along the first direction. However, absent unexpected results, it would have been prima facie obvious to one of ordinary skill to provide the two second photoelectric sensors are arranged at intervals along the first direction, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
As to during the movement of the lifting base in the first direction, the first sensing piece is driven to move between the two second photoelectric sensors, the device disclosed by Richards is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Richards is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraph [00164]. In other words, absent evidence to the contrary, the device disclosed by Richards would be able to perform the same functions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
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Regarding claim 8, Richards does not expressly discloses the rotating assembly further comprising a rotary driving mechanism, the rotary driving mechanism comprises a rotary driving member, a driving pulley, a driven pulley, and a conveyor belt; the rotary driving member is mounted on the fixing frame, and the driving pulley is connected to an output shaft of the rotary driving member, the driven pulley is mounted on the rotating member and is capable of rotating synchronously with the rotating member, the conveyor belt is sleeved between the drive pulley and the driven pulley.
However, absent unexpected results, it would have been an obvious matter of design choice to provide a rotary driving mechanism, the rotary driving mechanism comprises a rotary driving member, a driving pulley, a driven pulley, and a conveyor belt; the rotary driving member is indirectly mounted on the fixing frame, and the driving pulley is connected to an output shaft of the rotary driving member, the driven pulley is mounted on the rotating member and is capable of rotating synchronously with the rotating member, the conveyor belt is sleeved between the drive pulley and the driven pulley, since applicant has not disclosed that the monolithic bent plate solves any stated problem or provides a functionally that is not achieved by Richards. Further, it appears that the invention would perform equally well with the rotating assembly as taught by Richards, motivated by a reasonable expectation of success and the selection would have provided a predictable result, namely, an effective way of rotating the pipettor mandrel 1240 in the theta direction to accomplish the instrument’s pipetting tasks during ID and AST processes.
Regarding claim 12, the rejection of claim 11 above is relied upon. Richards discloses wherein two clamping mechanisms and two driving members (linear actuator 1120 and stepper motor 1020) are provided [00159], the two clamping mechanisms are respectively located on opposite sides of the cartridge loading position [00155].
Richards does not disclose the two clamping mechanisms are in one-to-one correspondence with the two driving members.
However, absent unexpected results, it would have been an obvious matter of design choice to provide two clamping mechanisms in one-to-one correspondence with the two driving members, since applicant has not disclosed that a one-to-one correspondence solves any stated problem and it appears that the invention would perform equally well with the cassette stage of Richards.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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