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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 requires that a PI control is done based on specific parameters, yet there is no disclosure on quite what a PI control actually is. Therefore, while it is clear that something is done, what exactly is being done isn’t quite clear. Without a definition of what a PI control would entail, it is not clear the Applicant had possession of the invention at the time of the filing.
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.
Claim 13 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.
The term “substantially” in claim 13 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bonds of what a substantial influence would be is not defined.
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.
Claim(s) 1-9 are is/are rejected under 35 U.S.C. 103 as being unpatentable over King (U.S. Patent Application Publication Number 2020/0164365), and further in view of Kowalski (U.S. Patent Number 5,139,744).
With respect to claim 1, King discloses and illustrates a device for incubating multiple patient samples using multiple incubation vessels, comprising: a first unit (40) having respective receptacles (34) for respective incubation vessels, where the respective unit is movably mounted in a respective position along a common linear guide axis (LFA) (see at least Figures 3-5), further comprising respective sensors (50) for providing respective sensor signals (see at least paragraph [[0043]), each of which indicates one of the respective positions, furthermore respective magnetic drive units (see at least paragraph [0021])) for respective changes of the respective positions, and furthermore a control unit (51) designed to control the respective magnetic drive units on the basis of the respective sensor signals to cause the respective changes of the respective positions (see at least paragraph [0043]). King fails to disclose and a second unit having respective receptacles for respective incubation vessels. King only discloses a single unit, sensor, and drive arrangement. However, King does disclose mounting holes 42 so that the baseplate can be positioned (fixed in place) for some other purpose, including incorporation into an overall automation system. Kowalski discloses an automated laboratory work station. As shown in at least Figure 1, there are at least 4 stations attached to a table 28. Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to use the microtiter plate system of King with the automated lab work station of Kowalski in order to provide a more precise control of the fluids in small volumes in an automated system such as in Kowalski.
With respect to claim 2, the device as claimed in claim 1, wherein the two units are each mounted and guided along the common linear guide axis (LFA) in such a way that they have only one common translational degree of freedom is shown in King in at least at least Figures 3-5.
With respect to claim 3, the device as claimed in claim 1, wherein a respective unit (40) is mechanically coupled to a common base plate (41) via a respective spring unit (46).
With respect to claim 4, the device as claimed in claim 3, wherein a respective unit (40) is mechanically coupled to the common base plate (41) via a respective spring unit (46) such that the respective unit (40) together with the respective spring unit (46) forms a respective spring-mass oscillation system (see at least Figures 3-5 of King).
With respect to claim 5, the device as claimed in claim 1, wherein the control unit (51) is designed to control the magnetic drive units (47) such that the units (40) are each maintained in oscillation with a respectively substantially identical oscillation amplitude in a direction of the linear guide axis (LFA) (see at least Figures 3-5).
With respect to claim 6, the device as claimed in claim 1, wherein the control unit (51) is designed to control the magnetic drive units (47) by means of feedback control on the basis of the sensor signals (see at least paragraph [0043] of King) such that resultant respective oscillation frequencies of the respective units are substantially identical and that the respective oscillation frequencies have a phase shift of substantially 180 degrees to each other (see at last paragraph [0079]).
With respect to claim 7, the device as claimed in claim 1, wherein the control unit (51) is designed to determine a respective current amplitude and a respective oscillation frequency for a respective unit (40) on the basis of a respective sensor signal (see at least paragraph [0043] of King), and wherein the control unit (51) is designed to adjust both units (40) to a common oscillation amplitude and a common, identical target oscillation frequency (see at last paragraph [0079]).
With respect to claim 8, the device as claimed in claim 3, wherein both units (40) with the respective spring units (46) each comprise a spring-mass oscillation system with a respectively identical resonance frequency (see at last paragraph [0058]) in an unloaded state and wherein a target oscillation frequency is below said resonance frequency (see at last paragraph [0086]).
With respect to claim 9, the device as claimed in claim 1, wherein the control unit (51) is designed to perform a PI control based on a common, identical target oscillation frequency (see at last paragraph [0076]).
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Kowalski as applied to claim 1 above, and further in view of Cook et al. (U.S. Patent Application Publication Number 2015/0132860; hereinafter referred to as Cook.).
With respect to claim 10, while King in view of Kowalski discloses the device as claimed in claim 1, King in view of Kowalski fails to disclose wherein both units have a respective heating unit. However, Cook teaches a clinical diagnostic system wherein there is a heater used in the incubation system. Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to use the heater disclosed in Cook with the system of King in view of Kowalski in order to maintain the temperature in the system to enable better reactions and performance of the system.
With respect to claim 11, an automated laboratory machine comprising a device as claimed in claim 1 is disclosed with King in view of Kowalski. However, King doesn’t disclose a device further comprising: a magazine (MAG) containing a plurality of incubation vessels (IG), a container (B1) containing a patient sample liquid (PPF), a container (B2) containing a buffer liquid (PUF), a container (B3) containing a bead liquid (BF) comprising beads coated with antigens or with antibodies, and a container (B4) containing a label liquid (AF) comprising antibodies or antigens labeled with a chemiluminescence label, a pipetting unit (PE) designed to dispense at least a portion of the patient sample liquid, at least a portion of the buffer liquid, at least a portion of the bead liquid and at least a portion of the label liquid into the incubation vessels and to aspirate them from the incubation vessels, and furthermore a gripping unit (G) designed to transfer incubation vessels from the magazine (MAG) to the pipetting unit (PE) and to transfer them from the pipetting unit (PE) to the respective receptacles (A), to remove them from the respective receptacles (A) and to transfer them back to the pipetting unit (PE). However, Cook teaches an automated laboratory machine (see at paragraph [0010])) further comprising: a magazine (114) containing a plurality of incubation vessels (see at least paragraph [0008]), a container (298) containing a patient sample liquid , a container containing a buffer liquid (131), a container containing a bead liquid (see at least paragraph [0146]) comprising beads coated with antigens or with antibodies (see at least paragraph [0146]), and a container containing a label liquid (see at least paragraph [0154]) comprising antibodies or antigens labeled with a chemiluminescence label, a pipetting unit (see at least paragraph [0106]) designed to dispense at least a portion of the patient sample liquid, at least a portion of the buffer liquid (see at least paragraph [0170]), at least a portion of the bead liquid and at least a portion of the label liquid into the incubation vessels and to aspirate them from the incubation vessels, and furthermore a gripping unit (see at least paragraph [0180]) designed to transfer incubation vessels from the magazine to the pipetting unit and to transfer them from the pipetting unit to the respective receptacles, to remove them from the respective receptacles and to transfer them back to the pipetting unit (see at least paragraph [0106]). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to incorporate the components disclosed in Cook with the system of King in view of Kowalski in order to provide a more complete handling of the sample to produce a more completely processed sample.
With respect to claim 12, while King in view of Kowalski disclosing the automated laboratory machine as claimed in claim 11, they fail to disclose a machine further comprising a container containing a liquid comprising an enzyme for implementation of a chemiluminescence reaction, and further comprising a reading unit for detecting an optical signal of a chemiluminescence reaction. However, Cook teaches a machine further comprising a container containing a liquid comprising an enzyme (see at least paragraph [0483]) for implementation of a chemiluminescence reaction, and further comprising a reading unit for detecting an optical signal of a chemiluminescence reaction (see at least paragraph [0153]). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to provide a means to enable a more completely processed sample.
With respect to claim 13, while King in view of Kowalski doesn’t disclose or teach the automated laboratory machine as claimed in claim 11, wherein the magnetic drives are arranged such that beads present in the bead liquid are not substantially influenced magnetically by magnetic fields of the magnetic drives, Cook teaches the methods achieve a highly effective wash method, by capturing the beads to be washed in a magnetic field, and then passing a liquid-and-air combination over the beads, in a fluidic channel using a very small amount of wash liquid (see Cook paragraph [0301]). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to utilize the teachings of Cook with the system of King in view of Kowalski such that you increase sensitivity and accuracy by decreasing the noise in the background.
With respect to claim 14, while King in view of Kowalski doesn’t disclose or teach the automated laboratory machine as claimed in claim 11, further comprising: a container containing a liquid comprising an enzyme for implementation of a chemiluminescence reaction , a dispensing unit for introducing the liquid comprising the enzyme into an incubation vessel, and a reading unit for detecting an optical signal of a chemiluminescence reaction. However, Cook teaches a liquid comprising an enzyme for implementation of a chemiluminescence reaction (see at least paragraph [0483]), a dispensing unit for introducing the liquid comprising the enzyme into an incubation vessel (see at least paragraph [0484]), and a reading unit for detecting an optical signal of a chemiluminescence reaction (see at least paragraph [0166]). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to use the teachings of Cook with the system of King in view of Kowalski in order to provide one of many failsafe mechanisms incorporated into the diagnostic system in order to provide a more reliable system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RODNEY T FRANK whose telephone number is (571)272-2193. The examiner can normally be reached M-F 9am-5:30pm.
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/RODNEY T FRANK/Examiner, Art Unit 2855
June 13, 2026
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