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 .
Response to Arguments
Applicant’s arguments, filed 4/9/2026, with respect to the rejection(s) of claim(s) 1 – 18 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Joseph et al. (US 2019/0285659 A1), have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Scott Lesher (EP 3 226 002 A1).
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 – 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al. (US 2019/0285659 A1; hereinafter “Joseph”) in view of S. Lesher (EP 3 226 002 A1; hereinafter “Lesher”).
Regarding claim 1, Joseph throughout the publication teaches a system comprising:
at least one in-vitro diagnosis device (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36), which is configured to carry out a diagnostic assay, the at least one in-vitro diagnosis device configured to detect a deviation of an internal calibration/control measurement parameter from a defined standard value, or a calibration curve, and forward it to a control unit (e.g., the main controller (host computer); paragraphs 40 and 41); and
at least one control unit (e.g., the main controller (host computer); paragraphs 40 and 41), which is bidirectionally connected to the at least one in-vitro diagnosis device (e.g., photometer calibration; paragraph 54) and is configured to perform an evaluation of the deviation of an internal calibration/control measurement parameter from a defined standard value of the at least one in-vitro diagnosis device, the at least one control unit additionally accessing data from a database for the evaluation (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54);
wherein the at least one control unit (e.g., the main controller (host computer); paragraphs 40 and 41) is configured to modify the standard value, for which a deviating internal calibration/control measurement parameter has been detected, and to transmit the modified standard value to the at least one in-vitro diagnosis device that detected the deviation to provide a consistent result value by the at least one in-vitro diagnosis device (the predetermined standard setup (a defined standard value) can be modified or changed depending on the photometer as specified by the manufacturer; paragraph 54).
Joseph does not specifically teach wherein the at least one control unit is also configured to transmit the modified standard value to one or more additional in-vitro diagnosis devices for use therein until the at least one control unit further modifies the modified standard value.
However, Lesher teaches a method and system for performing quality control on a diagnostic analyzer which includes receiving control measurement values for each of a plurality of diagnostic analyzers. The quality control value is compared with statistical criteria associated with the plurality of quality control measurement values received from the plurality of diagnostic analyzers. The plurality of peer group diagnostic analyzers receive the quality control measurement values from the quality control measurement values from the central server, which functions as a control unit (e.g., paragraphs 6 – 10). The quality control measurement values can be adjusted or modified as needed based on comparison data and transmitted to the plurality of diagnostic analyzers (e.g., paragraphs 11 – 13). The central server is configured to transmit the quality control measurement criteria or standard value to one or more diagnostic analyzers for use therein until the central server functioning as a control unit further modifies the quality measurement criteria or standard values. This same methodology for performing quality control can be applied in the Joseph system. Furthermore, it would have been logical to configure the control unit to keep transmitting the modified standard value to the one or more additional in-vitro diagnosis devices for use therein until the control unit further modifies the modified standard value, since the modified standard value already be considered to be the best and most accurate standard value being used in the operation of the in-vitro diagnostic devices until further modification and updating of the standard value is needed. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. "[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal, and even common sensical, we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references." Id. at 1368, 80 USPQ2d at 1651. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. In addition, the Examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007). In addition, the Supreme Court noted in KSR that although the test “captured a helpful insight,” an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person or ordinary skill in the art would employ.” See 127 S. Ct. at 1741, 82 USPQd at 1396. Thus, using the most recent data for the standard value would have been considered the best standard value to use until the quality control measurement is assessed and a modification in the modified standard value is required. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the at least one control unit is also configured to transmit the modified standard value to one or more additional in-vitro diagnosis devices for use therein until the at least one control unit further modifies the modified standard value.
Regarding claim 2, Joseph teaches the system as claimed in claim 1, wherein the internal calibration/control measurement parameter is associated with assay reagents used for carrying out the in-vitro diagnosis (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53).
Regarding claim 3, Joseph teaches the system as claimed in claim 1, wherein the internal calibration/control measurement parameter is a device system component parameter (e.g., paragraphs 53 and 54).
Regarding claim 4, Joseph teaches the system as claimed in claim 1, wherein the at least one control unit is configured to perform evaluations of deviations from a defined standard value as a function of assay reagent batches used (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53), the device system components, or the device type (e.g., reference measurements are compared to measurements from a predetermined standard setup depending on the standard/specified range (per wavelength) of the photometer as specified by the manufacturer; paragraphs 53 and 54).
Regarding claim 5, Joseph teaches the system as claimed in claim 1, wherein the at least one in-vitro diagnosis device is configured additionally to forward measurement data of a patient sample measured with a patient assay to the at least one control unit (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 6, Joseph teaches the system as claimed in claim 6, wherein the at least one control unit is additionally configured to evaluate the measurement data of the patient assay with the aid of previous measurement data of patient assays, controls or calibrations (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55).
Regarding claim 7, Joseph teaches the system as claimed in claim 1, wherein the evaluation comprises a comparison of the deviations of an internal calibration/control measurement parameter and measurement data of patient assays (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55) of a multiplicity of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36).
Regarding claim 8, Joseph teaches the system as claimed in claim 1, wherein the at least one control unit (e.g., the main controller (host computer); paragraphs 40 and 41) is configured to access a database containing data relating to the measurement or calibration/control measurement parameters associated with assay reagents or containing data relating to the device system component parameters or containing data relating to patient assays (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 9, Joseph teaches the system as claimed in claim 4, wherein the standard value is modified by a correction factor determined by:
(i) an individual deviation of an in-vitro diagnosis device from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(ii) an assay reagent batch-dependent deviation (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53) of a plurality of in-vitro diagnosis devices from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(iii) a deviation of measurement data of patient assays from previous measurement data of patient assays (the variance data or deviation of each sample measurement is compared to reference measurements and used to evaluate the quality of the analyzer system and increase the accuracy of testing results; paragraph 53),
(iv) a device type-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(v) a device system component-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(vi) a deviation of the measurement or calibration/control measurement parameters from measurement or calibration/control measurement parameters in a multiplicity of in-vitro diagnosis devices (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54), or
(vii) a combination of a device system component-dependent deviation, an assay reagent batch-dependent deviation, or a deviation from measurement data of patient assays (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 10, Joseph teaches the system as claimed in claim 1, wherein the at least one in-vitro diagnosis device is configured to detect the deviation of an internal calibration/control measurement parameter from a defined standard value once per hour, per 12 hours, per day (e.g., recalibration can be executed daily, hourly, etc., or repeated at a predetermined time interval set by the user or system manufacturer; paragraph 55), per 2, 3, 4, 5, 6 days, per week, per 2, 3 weeks, per month, per 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 months, per year or over the life cycle of the at least one in-vitro diagnosis device, assay reagents or a system component or a part of the life cycle, and forward it to the at least one control unit.
Regarding claim 11, Joseph teaches a method for modifying a defined standard value of an internal calibration/control measurement parameter of at least one in-vitro diagnosis device (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36), wherein the internal calibration/control measurement parameter measured in the in-vitro diagnosis device has a deviation from the standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54) (the variance data or deviation of each sample measurement is compared to reference measurements and used to evaluate the quality of the analyzer system and increase the accuracy of testing results; paragraph 53), comprising:
forwarding the deviation to at least one control unit (e.g., the main controller (host computer); paragraphs 40, 41, 43 and 44), evaluating the deviation in the at least one control unit (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54), and
transmitting a standard value modified on the basis of the deviation to the at least one in-vitro diagnosis device that detected the deviation (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Joseph does not specifically teach the step of transmitting a standard value modified by the at least one control unit on the basis of the deviation to the at least one in-vitro diagnosis device that detected the deviation and to one or more additional in-vitro diagnosis devices for use therein until the modified standard value is further modified.
However, Lesher teaches a method and system for performing quality control on a diagnostic analyzer which includes receiving control measurement values for each of a plurality of diagnostic analyzers. The quality control value is compared with statistical criteria associated with the plurality of quality control measurement values received from the plurality of diagnostic analyzers. The plurality of peer group diagnostic analyzers receive the quality control measurement values from the quality control measurement values from the central server, which functions as a control unit (e.g., paragraphs 6 – 10). The quality control measurement values can be adjusted or modified as needed based on comparison data and transmitted to the plurality of diagnostic analyzers (e.g., paragraphs 11 – 13). The central server is configured to transmit the quality control measurement criteria or standard value to one or more diagnostic analyzers for use therein until the central server functioning as a control unit further modifies the quality measurement criteria or standard values. This same methodology for performing quality control can be applied in the Joseph system. Furthermore, it would have been logical to configure the control unit to keep transmitting the modified standard value to the one or more additional in-vitro diagnosis devices for use therein until the control unit further modifies the modified standard value, since the modified standard value already be considered to be the best and most accurate standard value being used in the operation of the in-vitro diagnostic devices until further modification and updating of the standard value is needed. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. "[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal, and even common sensical, we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references." Id. at 1368, 80 USPQ2d at 1651. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. In addition, the Examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007). In addition, the Supreme Court noted in KSR that although the test “captured a helpful insight,” an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person or ordinary skill in the art would employ.” See 127 S. Ct. at 1741, 82 USPQd at 1396. Thus, using the most recent data for the standard value would have been considered the best standard value to use until the quality control measurement is assessed and a modification in the modified standard value is required. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the step of transmitting a standard value modified by the at least one control unit on the basis of the deviation to the at least one in-vitro diagnosis device that detected the deviation and to one or more additional in-vitro diagnosis devices for use therein until the modified standard value is further modified.
Regarding claim 12, Joseph teaches the method as claimed in claim 11, wherein the internal calibration/control measurement parameter is associated with assay reagents used for carrying out the in-vitro diagnosis, or is a device system component parameter (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53).
Regarding claim 13, Joseph teaches the method as claimed in claim 11, wherein the evaluating the deviation from a defined standard value is carried out as a function of assay reagent batches used (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53), the device system components, or the device type (e.g., reference measurements are compared to measurements from a predetermined standard setup depending on the standard/specified range (per wavelength) of the photometer as specified by the manufacturer; paragraphs 53 and 54).
Regarding claim 14, Joseph teaches the method as claimed in claim 11, wherein the evaluating comprises a comparison of the deviations of an internal calibration/control measurement parameter (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55) of a multiplicity of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36).
Regarding claim 15, Joseph teaches the method as claimed in claim 11, wherein the standard value is modified by a correction factor that is determined by:
(i) an individual deviation of an in-vitro diagnosis device from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(ii) an assay reagent batch-dependent deviation (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53) of a plurality of in-vitro diagnosis devices from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(iii) a deviation of measurement data of patient assays from previous measurement data of patient assays (the variance data or deviation of each sample measurement is compared to reference measurements and used to evaluate the quality of the analyzer system and increase the accuracy of testing results; paragraph 53),
(iv) a device type-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(v) a device system component-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(vi) a deviation of the measurement or calibration/control measurement parameters from measurement or calibration/control measurement parameters in a multiplicity of in-vitro diagnosis devices (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54), or
(vii) a combination of a device system component-dependent deviation, an assay reagent batch-dependent deviation, or a deviation from measurement data of patient assays (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 16, Joseph teaches the method as claimed in claim 11, further comprising forwarding measurement data of a patient assay to the at least one control unit (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 17, Joseph teaches the method as claimed in claim 11, further comprising detecting and forwarding periodically to the at least one control unit (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44) the deviation from initial measurements of the internal calibration/control measurement parameter or the deviation of the internal calibration/control measurement parameter from a defined standard value (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55).
Regarding claim 18, Joseph teaches the method as claimed in claim 17, wherein the forwarding periodically occurs once per hour; per 12 hours; per day (e.g., recalibration can be executed daily, hourly, etc., or repeated at a predetermined time interval set by the user or system manufacturer; paragraph 55); per 2, 3, 4, 5, 6 days; per week; per 2, 3 weeks; per month; per 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 months; per year; or over the life cycle of the at least one in-vitro diagnosis device, assay reagents, or a system component or a part of the life cycle.
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 BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (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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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
Prosecution Insights