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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 6-7 and 10 are objected to because of the following informalities: On lines 1-2 of claim 6, the phrase “wherein the storage unit is configured” should be changed to –wherein the at least one storage unit is configured—so as to recite the same terminology as recited in claim 4. On line 3 of claim 6, the phrase “wherein the microprocessor is configured” should be changed to –wherein the at least one microprocessor is configured for—so as to recite the same terminology as recited in claim 4 and to make proper sense. On line 4 of claim 6, the phrase “retrieving the at least one level signal from the storage unit” should be changed to -- retrieving the at least one level signal from the at least one storage unit-- so as to recite the same terminology as recited in claim 4. On both lines 5 and 9 of claim 7, the phrase “the instrument control software” should be changed to –the at least one instrument control software—so as to recite the same terminology as recited on line 3 of claim 7. On line 4 of claim 10, the word –and—should be inserted before the phrase “a horizontal level of the laboratory instrument”. On line 5 of claim 10, the phrase “for displaying the item of tilt information” should be changed to –for displaying the at least one item of tilt information—in order to recite the same terminology as recited in claim 1. Appropriate correction is required.
Inventorship
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 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.
Claim(s) 1-2 and 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakata et al (US 2024/0175885).
With regards to claims 1 and 11-12, Sakata et al teach of an automatic laboratory analyzer and a computer-implemented method for detecting for analyzing components in blood or urine (see paragraph 0002 and Figure 1A). The laboratory analyzer comprises a mechanism base 35 located on an upper plate 72b of a frame 70, reagent dispensing mechanisms 7, 8, a reaction disk 1, a reagent disk 11 and a reaction tank 36 mounted on the mechanism base 35, and a level or tilt sensor 60 arranged on an upper surface of the mechanism base 35. The frame 70 of the laboratory analyzer also comprises adjuster feet 37a, 37b, 37c and 37d which can be adjusted to appropriate heights in order to maintain the analyzer at a specific level. The laboratory analyzer also comprises an evaluation and control unit 41 configured for evaluating the level signal measured by the tilt or level sensor 60 thereby determining at least one item of tilt information on the laboratory analyzer. Specifically, the control unit 41 executes a tilt check by sensing a tilt amount of the analyzer at a specific time, such as during start of an analysis operation, and comparing the sensed tilt amount to a predetermined allowable threshold tilt amount stored in a data storage unit 42 of the control unit 41. If the tilt amount measured by the tilt sensor 60 exceeds the allowable tilt amount, an alarm is output and an abnormality in the tilting of the analyzer is notified to a user. In addition, a height of the adjuster feet 37a, 37b, 37c and 37d on the frame 70 of the analyzer may be adjusted in order to correct the tilt amount of the analyzer. Sakata et al also teach that the evaluation and control unit 41 is configured for determining at least one change in the level or tilt signal as compared to the allowable tilt amount in order to detect an interfering influence on the laboratory analyzer, wherein the interfering influence may be due to sinking of a floor upon which the analyzer is provided or an adjustment failure of the adjuster feet 37a, 37b, 37c and 37d (see paragraph 0033 in Sakata et al). The at least one change in the level or tilt signal is a change from a signal indicating a level orientation of the analyzer to a signal indicating a tilted orientation of the analyzer, wherein this at least one change in the level signal is due to an interfering influence such as a sinking floor upon which the analyzer rests or an adjustment failure of the adjuster feet 37a, 37b, 37c and 37d . The corresponding method taught by Sakata et al is operated by the evaluation and control unit 41, which comprises a microprocessor or computer and a storage unit 42, so that the method is at least partially computer-implemented (claims 11-12). Overall, see Figures 1A, 1B, 2A and 4, and paragraphs 0002, 0027, 0030-0031, 0033, 0036, 0039-0040 and 0044 in Sakata et al.
Sakata et al fail to teach that the at least one interfering influence on the laboratory analyzer is a mechanical shock or an abnormal mechanical vibration. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to detect a mechanical vibration or shock of the laboratory analyzer taught by Sakata et al as an interfering influence which causes an inclination or tilt of the analyzer to change from and exceed a threshold level because any unplanned movement or physical action on the analyzer would cause an unbalance and/or tilting of the analyzer from its horizontal plane on the mechanism base 35 of the analyzer, and a mechanical shock or vibration could cause the sinking of the floor upon which the analyzer rests or cause a failure of the adjuster feet 37a, 37b, 37c and 37d on the frame 70 of the analyzer, which are taught by Sakata et al as being interfering influences on the laboratory analyzer.
With regards to claim 2, Sakata et al teach that the evaluation and control unit 41 is configured for flagging results of the laboratory analyzer generated during the detected interfering influence, wherein the flagging of the results occurs by an output unit 46 that externally displays the results of the tilt information. See paragraphs 0027, 0031 and 0040 in Sakata et al.
With regards to claim 4, Niemeyer et al teach that the evaluation and control unit 207 comprises a microprocessor or a computer and a storage unit. See paragraphs 0027, 0032, 0036, 0054, 0068, 0175, and 0268-0269 in Niemeyer et al.
With regards to claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an electrically erasable programmable read-only memory (EEPROM) as the memory in the laboratory analyzer taught by Sakata et al because Sakata et al teach that the analyzer comprises a memory (see paragraph 0044 in Sakata et al), and an electrically erasable programmable read-only memory (EEPROM) would allow data to be stored and erased as desired so that the memory is reusable.
With regards to claim 6, Sakata et al teach that the storage unit 42 is configured
for receiving the level or tilt signal from the level or tilt sensor 60 and for storing the level signal,
wherein the microprocessor in the control unit 41 is configured retrieving the level signal from the storage unit 42 and for determining the change in the level signal by analyzing the retrieved level signal. See paragraph 0040 in Sakata et al.
With regards to claims 7, 13 and 14, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method taught by Sakata et al using a computer program, software and/or a non-transient computer-readable storage medium because Sakata et al teach that the control unit 41 functions as a computer (see paragraph 0030), and the use of a computer program, software and/or a non-transient computer-readable storage medium to perform the method taught by Sakata et al would allow the automation of the method without any user or manual intervention.
With regards to claim 8, Sakata et al teach that the tilt or level sensor 60 comprises a microelectromechanical system (MEMS). See paragraph 0037 in Sakata et al.
With regards to claim 9, Sakata et al teach that the level or tilt sensor 60 is arranged on a working plane of the laboratory analyzer, wherein the working plane is the mechanism base 35 of the analyzer. See Figure 1 and paragraph 0033 in Sakata et al.
With regards to claim 10, Sakata et al teach that the item of tilt information obtained by the tilt sensor 60 comprises a tilt of the working plane of the analyzer, which is the mechanism base 35. See paragraphs 0033-0036 in Sakata et al.
Claim(s) 1-2 and 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niemeyer et al (US 2019/0388889, submitted in the IDS filed on November 20, 2023).
With regards to claims 1 and 11-14, Niemeyer et al teach of a laboratory instrument, a method for detecting an interfering influence on a laboratory instrument, a computer program and a computer-readable storage medium comprising instructions for performing a method for detecting an interfering influence on a laboratory instrument (see paragraphs 001-0003, 0012, 0054 and 0268-0269 in Niemeyer et al). The laboratory instrument 1 comprises an analysis device 200, a cartridge 100, and a level or tilt sensor 206D configured for generating a level or tilt signal and detecting an inclination or orientation of the analysis device 200 and/or the cartridge 100 (see Figures 1 and 4, and paragraphs 0026 and 0174 in Niemeyer et al). The laboratory instrument further comprises an evaluation and control unit 207 configured for evaluating the level or tilt signal to thereby determine at least one item of tilt information on the laboratory instrument (see paragraphs 0027, 0175 and 0190 in Niemeyer et al). The evaluation and control unit 207 is further configured for determining a change in a level or tilt signal to thereby detect an interfering influence on the laboratory instrument. See paragraphs 0032, 0189 -0197 in Niemeyer et al where it describes how the measured tilt signal is compared to either a start threshold level or an interruption threshold level, and if the measured tilt signal is greater than the start or interruption threshold level, which indicates that the inclination of the laboratory instrument is too great, then the test is either not initiated or is interrupted. When the test on the instrument is interrupted, this indicates that some interfering influence on the instrument has occurred to cause its inclination to reach a level above the predetermined threshold level. The at least one change in the level or tilt signal is a change from the level signal from either the start threshold value 526 or an interruption threshold value 527. During dynamic performance of the test performed by the instrument taught by Niemeyer et al, if the test has to be interrupted because the level or tilt signal measured by the tilt sensor 206D is greater than the interruption threshold value 527, then an interfering influence has occurred to the laboratory instrument to cause the instrument to tilt to a greater degree than allowed for proper performance of the test. Niemeyer et al also teach that the method can be performed by a computer program or a computer-readable storage medium comprising instrument control software (see paragraphs 0268-0269). See Figures 1 and 4, and paragraphs 0001-0003, 0012-0013, 0017-0019, 0024-0036, 0043-0044, 0054, 0068, 0174-0197, 0268-0269 and 0278 in Niemeyer et al.
Niemeyer et al fail to teach that the at least one interfering influence on the laboratory analyzer is a mechanical shock or an abnormal mechanical vibration. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to detect a mechanical vibration or shock of the laboratory analyzer taught by Niemeyer et al as an interfering influence which causes an inclination or tilt of the analyzer to change from and exceed either the start threshold value 526 or the interruption threshold value 527 because any unplanned movement or physical action on the analyzer caused by either a mechanical vibration or shock would cause an unbalance and/or tilting of the analyzer from its horizontal plane on the analysis device 200, and if the test performed by the laboratory instrument taught by Niemeyer et al has to be interrupted because the level signal changes from the interruption threshold signal by more than the threshold amount, this indicates that the laboratory instrument has been exposed to some interfering influence, such as a mechanical shock or vibration.
With regards to claim 2, Niemeyer et al teach that the evaluation and control unit 207 is configured for flagging and displaying the results of the laboratory instrument generated during the detection of the interfering influence. See paragraphs 0032 and 0279 in Niemeyer et al.
With regards to claim 4, Niemeyer et al teach that the evaluation and control unit 207 comprises a microprocessor or a computer and a storage unit. See paragraphs 0027, 0032, 0036, 0054, 0068, 0175, and 0268-0269 in Niemeyer et al.
With regards to claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an electrically erasable programmable read-only memory (EEPROM) as the memory in the laboratory instrument taught by Niemeyer et al because Niemeyer et al teach that the instrument comprises a memory (see paragraphs 0068 and 0278 in Niemeyer et al), and an electrically erasable programmable read-only memory (EEPROM) would allow data to be stored and erased as desired so that the memory is reusable.
With regards to claim 6, Niemeyer et al teach that the control unit 207 is configured for receiving and storing the level or tilt signal from the level or tilt sensor 206D, wherein the computer in the control unit 207 is configured for retrieving the stored level signal and for determining the change in the level signal by analyzing the retrieved level signal. See paragraphs 0027, 0032, 0036 and 0043 in Niemeyer et al.
With regards to claim 7, Niemeyer et al teach that the evaluation and control unit 207 comprises instrument control software for assessing a detected interfering influence on the laboratory instrument. This assessment comprises comparing a measured tilt signal and a degree of inclination of the instrument from the tilt sensor 206D to a threshold value, and if the measurement result is greater than the threshold value, the software determines that some interfering influence on the instrument has occurred to cause its inclination to reach a level above the predetermined threshold level. See paragraphs 0026-0032 and 0268 in Niemeyer et al.
With regards to claim 8, Niemeyer et al teach that the tilt or level sensor 206D comprises a microelectromechanical system. See paragraph 0176 in Niemeyer et al.
With regards to claim 9, Niemeyer et al teach that the level or tilt sensor 206D is arranged on a working plane 212 of the laboratory analyzer. See Figure 1 and paragraphs 0174-0178 in Niemeyer et al.
With regards to claim 10, Niemeyer et al teach that the item of tilt information obtained by the tilt sensor 206D comprises a tilt of the working plane of the analyzer, which is the housing 212 of the analysis device 200. See Figure 1 and paragraphs 0174-0178 in Niemeyer et al.
Response to Arguments
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive.
The previous objection to the abstract made in the last Office action mailed on April 29, 2026 has been withdrawn in view of the amendments made to the abstract. The previous rejections of the claims under 35 USC 112(b) made in the last Office action have also been withdrawn in view of the amendments made to the claims. However, some of the amended claims are now objected to for minor informalities, as set forth above. The previous rejection of the claims under 35 USC 103 as being obvious over Baggio et al (US 2023/0258676) has been withdrawn in view of the amendments made to the claims and Applicant’s persuasive arguments with regards to this reference.
Applicant argues the previous rejections of the claims under 35 USC 102(a)(2) as being anticipated by Sakata et al, under 35 USC 102(a)(1) as being anticipated by Niemeyer et al, and under 35 USC 103 as being obvious over either Sakata et al or Niemeyer et al by stating that both Sakata et al and Niemeyer et al fail to teach or suggest that the interfering influence on the laboratory instrument which causes at least one change in the level signal is a mechanical shock or an abnormal mechanical vibration. Applicant argues that in both the analyzers taught by Sakata et al and Niemeyer et al, a static physical state is measured rather than dynamic changes in the level signal to detect a transient event because in Sakata et al, the level threshold comparisons are used to detect a sinking of a floor upon which the analyzer is provided or an adjustment failure of the adjuster feet, and in Niemeyer et al, a laboratory test is interrupted based on a static state when the inclination of the instrument is too great. Applicant argues that it would not be obvious to redesign the static tilt-checking systems taught by Sakata et al or Niemeyer et al into active, dynamic shock-monitoring systems, and neither Sakata et al or Niemeyer et al teach of continuously evaluating a level signal to determine a dynamic change for the purpose of detecting transient events like a mechanical shock or an abnormal mechanical vibration.
These arguments are not persuasive since the instant claims do not recite that the at least one level signal is measured continuously or repeatedly during operation of the laboratory instrument to monitor dynamic changes in the tilt or inclination of the instrument due to a mechanical shock or vibration. Rather, the instant claims recite “determining at least one change in the at least one level signal” to detect an interfering influence comprising either a mechanical shock or an abnormal mechanical vibration of the laboratory instrument, which can mean that only one change of a single level signal is measured in the method and instrument, as opposed to many level signals measured continuously during a test performed by the instrument to measure a dynamic change. In the instrument and method taught by Sakata et al, the at least one change in the level or tilt signal is a change from a signal indicating a level orientation of the analyzer to a signal indicating a tilted orientation of the analyzer, wherein this at least one change in the level signal is due to an interfering influence such as a sinking floor upon which the analyzer rests or an adjustment failure of the adjuster feet 37a, 37b, 37c and 37, and both a sinking floor or a failure of the adjustment feet could reasonably be expected by one of ordinary skill in the art to occur as a result of a mechanical shock or vibration of the analyzer.
This argument is also not persuasive with regards to the reference to Niemeyer et al since Niemeyer et al teach of measuring at least one change in the level or tilt signal from either a start threshold value 526 of the level signal at the start of operation of the laboratory instrument or from an interruption threshold value 527 of the level signal measured dynamically during operation of the laboratory instrument. During dynamic performance of the test performed by the instrument taught by Niemeyer et al, if the test has to be interrupted because the level or tilt signal measured by the tilt sensor 206D is greater than the interruption threshold value 527, then an interfering influence has occurred to the laboratory instrument to cause the instrument to tilt to a greater degree than allowed for proper performance of the test. One of ordinary skill in the art would expect that any type of influence that causes a movement of the laboratory instrument taught by Niemeyer et al, such as a mechanical shock or an abnormal mechanical vibration, would serve to tilt the instrument from a level, horizontal position, and subsequently cause a change of the level or tilt signal from either the start threshold value 526 or the interruption threshold value 527. Additionally, if the test performed by the laboratory instrument is interrupted due to the measured level signal being greater than the interruption signal threshold 527, then this means that the level signal measured by the level or tilt sensor 206D is measured continuously or dynamically over the time period that the instrument is being operated. See paragraphs 0190-0197 in Niemeyer et al.
For all of the above reasons, Applicant’s arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 August 20, 2026
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