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 .
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 4 is 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.
On lines 2-3 of claim 4, the phrase “provided by the light unit” is indefinite since it is not commensurate in scope with the “at least one light unit” recited earlier in the claim. Therefore, this phrase should be changed to –provided by the at least one light unit--.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 6, 8-9 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lohan et al (WO 2020/123437, submitted in the IDS filed on March 8, 2024).
With regards to claims 1 and 8, Lohan et al teach of a sample tube handling system (see paragraph 0008 in Lohan et al where it states “In some embodiments, an apparatus for holding sample tubes is provided”, and paragraph 0062 in Lohan et al where it states “Described are racks for supporting, carrying, and transporting reagents and samples for various purposes, in particular in connection with sample preparation in a clinical context. The rack permits placement and retention of one or more sample tubes”) comprising: one or more carriers or racks 100 configured to carry a plurality of sample tubes (see paragraph 0062 in Lohan et al where it states “Described are racks for supporting, carrying, and transporting reagents and samples for various purposes, in particular in connection with sample preparation in a clinical context. The rack permits placement and retention of one or more sample tubes” and paragraph 0072 in Lohan et al where it states “The rack 100 is configured to accept a number of sample tubes 102…the rack 100 is configured to hold and retain one or more such sample tubes 102..”), a deck surface including a designated location for each of the one or more carriers (see paragraph 0064 in Lohan et al where it states “The racks are configured to be insertable into, and removable from, a diagnostic apparatus.”, paragraph 0072 in Lohan where it states “The rack 100 is configured to permit access to the sample tubes 102 to be accessed by one or more other functions of the diagnostic apparatus, such as automated pipetting”, paragraph 0133 in Lohan et al where it states “the rack 100 can be loaded with one or more sample tubes 102 only prior to being inserted into the diagnostic apparatus 300 such as used with a receiving bay with the partition 250”, paragraph 0128 in Lohan et al where it states “Figure 17 shows an example diagnostic apparatus 300…the rack 100 can be designed so that it can be easily inserted and removed from the diagnostic apparatus 300”, and Figure 17 in Lohan et al which depicts the carrier 100 being inserted into a flat surface of the diagnostic apparatus 300, wherein the receiving bay of the diagnostic apparatus 300 is the “designated location”), and a warning system that produces a warning signal when at least one of the one or more carriers is not in its designated location (see paragraph 0129 in Lohan et al where it states “the rack 100 or the diagnostic apparatus 300 can include a sensor configured to indicate proper placement of the rack 100 in the diagnostic apparatus 300. The sensor may communicate with a processor to provide the user with a warning, such as an audible warning, or a visual warning communicated via an interface, if the rack 100 is not seated correctly”). If the rack or carrier 100 is not seated correctly, then the rack or carrier 100 is not in its designated location in the diagnostic apparatus 300. It is noted that the flat surface of the diagnostic apparatus 300 taught by Lohan et al that comprises a receiving bay for receiving the racks or carriers 100 constitutes a “deck” as defined in the instant specification since it serves as a working surface for the carriers 100 during diagnostic functions of the apparatus, which is the definition of the “deck” provided in paragraph 0010 of the instant specification. See Figures 1 and 17, and paragraphs 0008, 0062, 0064, 0072, 0128-0129 and 0133 in Lohan et al.
With regards to claims 2 and 9, Lohan et al teach that the warning system of the sample tube handling system comprises a sensor unit that is positioned in the sample tube handling system to detect whether each of the one or more carriers 100 is in its designated location and produces the warning signal when at least one of the one or more carriers 100 is not in its designated location (see paragraph 0129 in Lohan et al where it states “the rack 100 or the diagnostic apparatus 300 can include a sensor configured to indicate proper placement of the rack 100 in the diagnostic apparatus 300. The sensor may communicate with a processor to provide the user with a warning, such as an audible warning, or a visual warning communicated via an interface, if the rack 100 is not seated correctly”).
With regards to claims 6 and 13, Lohan et al teach that the warning system does not produce any warning signal when the one or more carriers are in their designated locations. See paragraph 0129 in Lohan et al where it states “the rack 100 or the diagnostic apparatus 300 can include a sensor configured to indicate proper placement of the rack 100 in the diagnostic apparatus 300. The sensor may communicate with a processor to provide the user with a warning, such as an audible warning, or a visual warning communicated via an interface, if the rack 100 is not seated correctly”. From this phrase in Lohan et al, it is reasonably understood that the warning system does not produce any warning signal when the one or more carriers 100 are in their designated locations.
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.
Claim(s) 3-5 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lohan et al (WO 2020/123437, submitted in the IDS filed on March 8, 2024) in view of Winkler et al (US 2009/0162941, submitted in the IDS filed on March 8, 2024). For a teaching of Lohan et al, see previous paragraphs in this Office action.
With regards to claims 3-5 and 10-12, Lohan et al fail to teach that the warning system comprises at least one buzzer that produces an audible signal when the one or more carriers 100 are not in their designated locations in the sample tube handling system, and/or comprises at least one light unit that produces a visual signal when the one or more carriers 100 are not in their designated locations in the sample tube handling system.
Winkler et al teach of a stopper for a container holding liquids (see paragraph 0005 in Winkler et al), wherein a buzzer notifies a user when a sensor detects that the stopper has not been correctly inserted into the top of a tube, or a visual light sensor notifies a user when a sensor detects that the stopper has not been correctly inserted into the top of a tube. See paragraph 0065 in Winkler et al which states “A rocker or shaker may comprise an opening that will only fit a stopper in a single orientation. Alternately, the rocker or shaker may comprise a sensor that notifies a user when a stopper is not properly inserted or is incorrectly oriented into the opening of the device or receptacle. The sensor may comprise an optical sensor (including by not limited to a visual light sensor or an infrared sensor), a pressure sensor, or a magnetic sensor. Notification to a user may be communicated via a graphical display, a warning light (such as a flashing light), an auditory warning (such as a buzzer or bell), a vibratory warning or any combination thereof”.
With regards to claims 3-5 and 10-12, and based upon the combination of Lohan et al and Winkler et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the warning system of the sample tube handling system taught by Lohan et al a buzzer that produces an audible signal when the one or more carriers 100 are not in their designated locations in the sample tube handling system, and/or at least one light unit that produces a visual signal when the one or more carriers 100 are not in their designated locations in the sample tube handling system because Lohan et al teach that the warning system produces either an audible or a visual warning signal when at least one of the one or more carriers 100 is not in its designated location, and Winkler et al teach that common warning signals produced by sensors for indicating the improper placement of parts in a device are audible signals produced by a buzzer or visual signals such as a warning or flashing light produced by a visual light unit.
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lohan et al (WO 2020/123437, submitted in the IDS filed on March 8, 2024) in view of Horie et al (US 2021/0096148). For a teaching of Lohan et al, see previous paragraphs in this Office action.
With regards to claims 7 and 14, Lohan et al fail to teach that the sensor unit in the warning system of the sample tube handling system comprises a distance sensor for each of the designated locations for each of the one or more carriers, that measures a distance between the distance sensor to a surface that is in the distance sensor’s line of sight, wherein the sample tube handling system uses the measured distance to detect whether each of the one or more carriers is in its designated location.
Horie et al teach of an automatic analyzer 10 comprising conveyance racks or carriers 22 holding sample tubes 21. The analyzer 10 also comprises a distance sensor 200 in a liquid level sensing mechanism 23 that includes a circuit which processes the transmission and reception of sound waves by piezoelectric elements, calculates the distance to a liquid level in the sample tubes 21 from the time from transmission to reception of a sound wave, and outputs a voltage corresponding to the distance. Horie et al also teach that the distance sensor 200, as depicted in Figure 2c, can be used to detect a distance between the distance sensor 200 to a surface of the conveyance rack or carrier 22 that is in the distance sensor’s line of sight, so that the location of the rack or carrier 22 in the automated analyzer can be detected. See paragraph 0034 in Horie et al where it states “Fig. 2(c) is a schematic view illustrating a state of liquid level sensing by the conventional ultrasonic distance sensor 200…When an ultrasonic wave is transmitted downward from the ultrasonic distance sensor 200 at the upper part, a diffusion of a sound wave as illustrated by the dotted line is generated, and when the diffused sound wave collides with something, it is reflected there. Reflected waves are detected by the ultrasonic distance sensor 200, and signals corresponding to the respective reflected waves are generated. Other than those illustrated in the figure, sound waves are reflected from the conveyance rack 22…”, paragraph 0037 in Horie et a where it states “R3 is a detection signal based on a reflected wave from the top surface of the conveyance rack”, and paragraph 0054 in Horie et al where it states “Similarly, at the timing when the top surface of the conveyance rack 22 moves under the ultrasonic distance sensor, the control of the lowering of the sound wave guide is performed.. It is to be noted that since the top surface of the conveyance rack 22 has a large area, it can be sensed even without the sound wave guide…the liquid level sensing system illustrated in Figure 7 is capable of measuring… the position at the top surface of the conveyance rack 22”.
With regards to claims 7 and 14, and based upon the combination of Lohan et al and Horie et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a distance sensor as the sensor unit in the warning system of the sample tube handling system taught by Lohan et al that measures a distance between the distance sensor to a surface of the one or more carriers 100 that is in the distance sensor’s line of sight so as to detect whether each of the one or more carriers is in its designated location because Lohan et al teach that a sensor in the sample tube handling system serves to indicate the proper placement of the carriers 100 in a surface of the diagnostic apparatus 300, and Horie et al teach that a distance sensor that measures a distance between the distance sensor to a surface of one or more carriers holding tubes in an automated analyzer that is in the distance sensor’s line of sight is one common way in which to detect the one or more carriers in the analyzer, and thus, determine whether the one or more carriers are correctly positioned in the analyzer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Vansickler et al (US 2020/0319219) who teach of an automated sample preparation system for diagnostic testing; Luoma, II (US 2007/0010019) who teach of a diagnostic assay system comprising a loading bay to receive and hold a plurality of carriers holding containers of reagents; and Antinjuntti (US 2019/0234977) who teach of a method for attaching a movable sample vessel rack in an apparatus containing a distance sensor for sensing when the movable vessel rack is in a locking position in the apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 3, 2026
