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 Amendment
The Amendments to the Claims filed 05/14/2026 have been entered. Claims 1, 4, 6-8, 11, 13-15, 18, and 20 are pending in the application. Claims 2-3, 5, 9-10, 12, 16-17, and 19 have been canceled. Applicant’s amendment to the Claims have overcome each and every 35 U.S.C. 112(b) rejection previously set forth in the Non-final rejection dated 01/29/2026. Due to amendments to the claims new 35 U.S.C. 103 rejections are presented below.
Claim Rejections - 35 USC § 112
As noted above the 35 U.S.C. 112(b) rejections previously set forth have been overcome by amendment to the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 6-8, 13-15, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract idea without significantly more.
With respect to claim 1 the limitation(s):
A method comprising:
receiving, by a specimen collection scheduler of an outpatient laboratory computing system, a request to schedule a future measurement of an analyte at some time in the future;
determining, by the specimen collection scheduler, a time delta between consecutive measurements including an immediately previous measurement and the future measurement, the consecutive measurements including a proposed date and time of the future measurement of the analyte and an actual date and time of the immediately previous measurement of the analyte on a same patient;
responsive to confirming the time delta is within a same specified time of day window as the immediately previous measurement and the future measurement is within a same season as the immediately previous measurement, the same season means that the proposed date of the future measurement falls in a next calendar year and within 29 calendar days of the calendar date of the immediately previous measurement, so that seasonal biological variation between the future measurement and the immediately previous measurement is minimized,
adding the future measurement of the analyte to a schedule at the proposed time; and
collecting, by a laboratory analyzer, the analyte from the same patient in accord with the schedule, the laboratory analyzer is a clinical chemistry or hematology analyzer configured to analyze a biological specimen obtained from the patient.
These limitation(s) highlighted in (bold) is/are directed to an abstract idea and would fall within the “Mental Processes” groupings of abstract ideas. The above portion(s) of the claim(s) constitute(s) an abstract idea because:
The limitation(s) regarding “determining, by the specimen collection scheduler, a time delta between consecutive measurements including an immediately previous measurement and the future measurement, the consecutive measurements including a proposed date and time of the future measurement of the analyte and an actual date and time of the immediately previous measurement of the analyte on a same patient”, as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “an outpatient laboratory computing system,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “an outpatient laboratory computing system” language, “determining” in the context of this claim encompasses the user manually determining a difference in time between a prior date and a future date.
The limitation(s) regarding “responsive to confirming the time delta is within a same specified time of day window as the immediately previous measurement and the future measurement is within a same season as the immediately previous measurement, the same season means that the proposed date of the future measurement falls in a next calendar year and within 29 calendar days of the calendar date of the immediately previous measurement, so that seasonal biological variation between the future measurement and the immediately previous measurement is minimized”, as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “an outpatient laboratory computing system,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “an outpatient laboratory computing system” language, “confirming” in the context of this claim encompasses the user manually confirming that a future date is within a time window and during a time of day window.
The limitation(s) regarding “adding the future measurement of the analyte to a schedule at the proposed time”, as drafted, is an act of observation and evaluation that, under its broadest reasonable interpretation, covers performance of the limitation(s) in the mind. That is, other than reciting “an outpatient laboratory computing system,” nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, but for the “an outpatient laboratory computing system” language, “adding” in the context of this claim encompasses the user manually adding a proposed time to a schedule.
Further, referring to the MPEP 2106.04, the claim limitations are analogous to a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
This judicial exception is not integrated into a practical application because the non- abstract additional elements of the claims do not impose meaningful limits on practicing the abstract idea(s) recited in the preceding claim(s). In particular, the claims recited the additional elements of:
The limitation(s) regarding “collecting, by a laboratory analyzer, the analyte from the same patient in accord with the schedule, the laboratory analyzer is a clinical chemistry or hematology analyzer configured to analyze a biological specimen obtained from the patient” does/do not integrate the abstract idea into a practical application because the claim does not specify what practical application the claim is directed to. Rather the limitation is recited at such a high-level of generality that it amounts to no more than adding insignificant extra- solution activity to the judicial exception, i.e. data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they are regarded as data gathering steps necessary or routine to implement the abstract idea.
The limitation(s) regarding “receiving, by a specimen collection scheduler of an outpatient laboratory computing system, a request to schedule a future measurement of an analyte at some time in the future” does/do not integrate the abstract idea into a practical application because the claim does not specify what practical application the claim is directed to. Rather the limitation is recited at such a high-level of generality that it amounts to no more than adding insignificant extra- solution activity to the judicial exception, i.e. insignificant application. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they are regarded as not imposing meaningful limits on the claim such that it is not nominally or tangentially related to the invention.
The limitation(s) regarding “a specimen collection scheduler” and “an outpatient laboratory computing system” does/do not integrate the abstract idea into a practical application because the claim limitation is a generic computer component performing the generic computer function of receiving, storing, and comparing data such that it amounts to no more than mere instruction to apply the exception using a generic computer component.
As such Examiner does NOT view that the claims:
-Improve the functioning of a computer, or to any other technology or technical field;
-Apply the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b);
-Effect a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c); or
-Apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception – see MPEP 2106.05(e) and Vanda Memo.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements amount to no more than mere instructions to apply the exception using a generic computer component, or are well-understood, routine, and conventional (WURC) data gathering functions.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s) of “receiving a request” and “collecting the analyte” is/are viewed as insignificant extra-solution activity, such as mere data gathering in a conventional way and, therefore, does not provide an inventive concept. Similarly, with regards to the additional element(s) of “a specimen collection scheduler” and “an outpatient laboratory computing system” is/are view as a generic computer component performing the generic computer function of receiving, storing, and comparing data such that it amounts to no more than mere instruction to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Examiner further notes that such additional elements are viewed to be well- understood, routine, and conventional (WURC) as evidenced by: Taub et al. (US 20120108931 A1); Cembrowski et al. (US 20160370394 A1); Cembrowski et al. (US 20190035490 A1); Parvin et al. (US 20070198213 A1); Glauser et al. (US 20200393476 A1); Larson (US 20070226010 A1); Wang et al. (Wang, Shuo, et al. "Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes." Clinical Chemistry and Laboratory Medicine (CCLM) 60.4 (2022): 606-617.); Johnson et al. (Johnson, Paul R., Shahram Shahangian, and J. Rex Astles. "Managing biological variation data: modern approaches for study design and clinical application." Critical Reviews in Clinical Laboratory Sciences 58.7 (2021): 493-512.); and Wyse et al. (Wyse, Cathy, et al. "Seasonal and daytime variation in multiple immune parameters in humans: Evidence from 329,261 participants of the UK Biobank cohort." Iscience 24.4 (2021).).
Considering the claim as a whole, one of ordinary skill in the art would not know the practical application of the present invention since the claims do not apply or use the judicial exception in some meaningful way. As currently claimed, Examiner views that the additional elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, because the claims fails to recite clearly how the judicial exception is applied in a manner that does not monopolize the exception because the limitation regarding “receiving a request,” “collecting the analyte,” “a specimen collection scheduler” and “an outpatient laboratory computing system” can be viewed as necessary data gathering and any device and do not impose a meaningful limitation describing what problem is being remedied or solved.
Independent claims 8 and 15 are also held to be patent ineligible under 35 U.S.C. 101 because the additionally recited limitations fail to establish that the claims are not directed to an Abstract idea. Claims 8 and 15 recites the additional elements of:
The limitation(s) regarding “a compute device,” and “A machine readable storage device” does/do not integrate the abstract idea into a practical application because the claim does not specify what practical application the claim is directed to. Rather the limitation is recited at such a high-level of generality that it amounts to a generic computer component performing the generic computer function of receiving, storing, and comparing data such that it amounts to no more than mere instruction to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 6-7, 13-14, and 20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additionally recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea, as detailed below: there are no additional element(s) in the dependent claims that adds a meaningful limitation to the abstract idea to make the claims significantly more than the judicial exception (abstract idea).
Claims 6-7, 13-14, and 20 further limit the abstract idea with an abstract idea, such as an “Mental Processes” and “Mathematical Concepts”, and thus the claims are still directed to an abstract idea without significantly more.
Claims 4, 11, and 18 are seen as applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As such, claims 4, 11, and 18 are not rejected under 35 USC 101.
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, 6-8, 13-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20070226010 A1) in view of Wang et al. (Wang, Shuo, et al. "Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes." Clinical Chemistry and Laboratory Medicine (CCLM) 60.4 (2022): 606-617.) and Cembrowski et al. (US 20160370394 A1).
Regarding Claims 1, 8, and 15. Larsen teaches:
A method comprising:
receiving, by a specimen collection scheduler of an outpatient laboratory computing system, a request to schedule a future measurement of an analyte at some time in the future (See para[0018]: The present invention provides a system for allowing patients or proxies for those patients to electronically scheduling medical resources. The resources scheduled can include… laboratory time.);
adding the future measurement of the analyte to a schedule at the proposed time (See para[0018]: After schedule options are provided to the patient, the computer system can accept an input from the patient interface terminal to select an appointment from the schedule options, and submit the appointment data to scheduling software for the healthcare provider to directly schedule an appointment.); and
collecting, by a laboratory analyzer, the analyte from the same patient in accord with the schedule, the laboratory analyzer is a clinical chemistry or hematology analyzer configured to analyze a biological specimen obtained from the patient (See para[0102]: a procedure can be a visit to a medical practitioner, or consist of a multi-step process including laboratory testing.).
Larsen is silent as to the language of:
determining, by the specimen collection scheduler, a time delta between consecutive measurements including an immediately previous measurement and the future measurement, the consecutive measurements including a proposed date and time of the future measurement of the analyte and an actual date and time of the immediately previous measurement of the analyte on a same patient;
responsive to confirming the time delta is within a same specified time of day window as the immediately previous measurement and the future measurement is within a same season as the immediately previous measurement, the same season means that the proposed date of the future measurement falls in a next calendar year and within 29 calendar days of the calendar date of the immediately previous measurement, so that seasonal biological variation between the future measurement and the immediately previous measurement is minimized.
Nevertheless Wang teaches:
responsive to confirming the time delta is within a same specified time of day window as the immediately previous measurement (See page 607, Sample collection and measurement: Fasting blood samples were collected in the morning from cubital vein.) and
the future measurement is within a same season as the immediately previous measurement, the same season means that the proposed date of the future measurement falls in a next calendar year and within 29 calendar days of the calendar date of the immediately previous measurement, so that seasonal biological variation between the future measurement and the immediately previous measurement is minimized (See Abstract Compared with weekly BV, for annual healthcare individuals, annual BV and related parameters can provide more accurate evaluation of laboratory results. RIper based on long-term BV data is very valuable for “personalized” diagnosis on annual health assessments.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Larsen by confirming the time delta is within a same specified time of day window as the immediately previous measurement and the future measurement is within a same season as the immediately previous measurement, the same season means that the proposed date of the future measurement falls in a next calendar year and within 29 calendar days of the calendar date of the immediately previous measurement, so that seasonal biological variation between the future measurement and the immediately previous measurement is minimized such as that of Wang. One of ordinary skill would have been motivated to modify Larsen, because determining that a measurement was within a time of day window and during the same season would have helped to provide more accurate evaluation of laboratory results, as recognized by Wang.
Wang is silent as to the language of:
determining, by the specimen collection scheduler, a time delta between consecutive measurements including an immediately previous measurement and the future measurement, the consecutive measurements including a proposed date and time of the future measurement of the analyte and an actual date and time of the immediately previous measurement of the analyte on a same patient.
Nevertheless Cembrowski teaches:
determining, by the specimen collection scheduler, a time delta between consecutive measurements including an immediately previous measurement and the future measurement, the consecutive measurements including a proposed date and time of the future measurement of the analyte and an actual date and time of the immediately previous measurement of the analyte on a same patient (See Fig. 2 and para[0043]: A time delta can be calculated for consecutive measurements of the same patient at operation 205.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Larsen by determining, by the specimen collection scheduler, a time delta between consecutive measurements including an immediately previous measurement and the future measurement, the consecutive measurements including a proposed date and time of the future measurement of the analyte and an actual date and time of the immediately previous measurement of the analyte on a same patient such as that of Cembrowski. Cembrowski teaches, “The closer the time delta range is to twenty-four hours, the lower a biologic variation is expected to be, thus a smaller value delta is expected” (See para[0039]). One of ordinary skill would have been motivated to modify Larsen, because determining a time delta between two measurements would have helped to determine the amount of biologic variation between measurements, as recognized by Cembrowski.
Regarding Claims 6, 13, and 20. Larson is silent as to the language of:
The method of claim 1, the system of claim 8, or the machine readable storage device of claim 15,
further comprising
comparing the immediately previous measurement to a range of acceptable measurement values and discarding the immediately previous measurement if it is not within the range of acceptable measurement values.
Nevertheless Cembrowski teaches:
comparing the immediately previous measurement to a range of acceptable measurement values and discarding the immediately previous measurement if it is not within the range of acceptable measurement values (See para[0038]: The value delta threshold can be set by an expert or other personnel and can be set based on the analyte and the amount of error that is considered acceptable in the result without giving a false positive on determining that the laboratory analyzer 102 is to be calibrated. If a calculated value delta is greater than the value delta threshold, the filter 110 can remove the value delta from the results used by the AoD module 104 to calculate the AoD.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Larsen by comparing the immediately previous measurement to a range of acceptable measurement values and discarding the immediately previous measurement if it is not within the range of acceptable measurement values such as that of Cembrowski. Cembrowski teaches, “The value delta threshold can be set by an expert or other personnel and can be set based on the analyte and the amount of error that is considered acceptable in the result without giving a false positive on determining that the laboratory analyzer 102 is to be calibrated” (See para[0038]). One of ordinary skill would have been motivated to modify Larsen, because discarding measurements outside an acceptable range would have helped to reduce calibration false positives, as recognized by Cembrowski.
Regarding Claims 7 and 14. Larson is silent as to the language of:
The method of claim 1 or the system of claim 8,
wherein
determining whether an average of deltas of the consecutive measurements is within a specified range of acceptable average of delta values includes comparing a standard deviation of a plurality of consecutive average of delta values to a threshold standard deviation value and
the method further comprises determining the laboratory analyzer is to be calibrated in response to determining the standard deviation is greater than the threshold standard deviation.
Nevertheless Cembrowski teaches:
determining whether an average of deltas of the consecutive measurements is within a specified range of acceptable average of delta values includes comparing a standard deviation of a plurality of consecutive average of delta values to a threshold standard deviation value (See para[0065]: wherein determining whether the average of deltas is within a specified range of acceptable average of delta values includes comparing a standard deviation of a plurality of consecutive average of delta values to a threshold standard deviation value.) and
the method further comprises determining the laboratory analyzer is to be calibrated in response to determining the standard deviation is greater than the threshold standard deviation (See para[0065]: the method further comprises determining the laboratory analyzer is to be calibrated in response to determining the standard deviation is greater than the threshold standard deviation.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Larson by determining whether an average of deltas of the consecutive measurements is within a specified range of acceptable average of delta values includes comparing a standard deviation of a plurality of consecutive average of delta values to a threshold standard deviation value and the method further comprises determining the laboratory analyzer is to be calibrated in response to determining the standard deviation is greater than the threshold standard deviation such as that of Cembrowski. Cembrowski teaches, “The Standard Deviation of Duplicates (SDD) and/or average of deltas (AoD) can be calculated to determine systematic error in a laboratory analyzer and/or increased random error in the laboratory analyzer” (See para[0026]). One of ordinary skill would have been motivated to modify Larson, because determining if an analyzer needs to be calibrated using an average of deltas and a standard deviation would have helped to determine systematic error in an analyzer, as recognized by Cembrowski.
Claim(s) 4, 11, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 20070226010 A1) in view of Wang et al. (Wang, Shuo, et al. "Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes." Clinical Chemistry and Laboratory Medicine (CCLM) 60.4 (2022): 606-617.) and Cembrowski et al. (US 20160370394 A1) as applied to claims 1, 8, and 15 above, and further in view of Cembrowski et al. (US 20190035490 A1), herein Cembrowski’490.
Regarding Claims 4, 11, and 18. Larson is silent as to the language of:
The method of claim 1, the system of claim 8, or the machine readable storage device of claim 15,
further comprising:
determining a running Dahlberg's analysis for which the time delta is within the time of day windows, and the same season resulting in a Dahlberg variation;
determining the Dahlberg variation is greater than a specified threshold; and
calibrating the laboratory analyzer if the Dahlberg variation is greater than the specified threshold and an average of deltas of the consecutive measurements of the analyte is not within a specified range of acceptable average of delta values.
Nevertheless Cembrowski’490 teaches:
determining a running Dahlberg's analysis for which the time delta is within time of day windows, and the same season resulting in a Dahlberg variation (See para[0075] – para[0076]: For each time interval, the standard deviation of duplicates (SDD) can be calculated for all of the QC pairs or intra-patient test pairs within that interval
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determining the Dahlberg variation is greater than a specified threshold (See para[0048], para[0058], and para[0171]: If the AoD calculation is out of range, such as can be indicated by the SDD exceeding a specified SDD limit, then an error flag can be turned on.); and
calibrating the laboratory analyzer if the Dahlberg variation is greater than the specified threshold and an average of deltas of the consecutive measurements of the analyte is not within a specified range of acceptable average of delta values (See para[0030], para[0046], and para[0058]: an AoD or a standard deviation of AoDs exceeding a threshold. indicating a significant analytical shift. A significant analytical shift can mean that the laboratory analyzer requires servicing, such as usually includes re-calibration.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Larson by determining a running Dahlberg's analysis for which the time delta is within the specified number of days, time of day windows, and the same season resulting in a Dahlberg variation; determining the Dahlberg variation is greater than a specified threshold; and calibrating the laboratory analyzer if the Dahlberg variation is greater than the specified threshold and an average of deltas of the consecutive measurements of the analyte is not within a specified range of acceptable average of delta values such as that of Cembrowski’490. Cembrowski’490 teaches, “The Standard Deviation of Deltas (SDD) and/or average of deltas (AoD) can be calculated to determine systematic error in a laboratory analyzer and/or increased random error in the laboratory analyzer” (See para[0043]). One of ordinary skill would have been motivated to modify Larson, because using a Dahlberg variation would have helped to determine systematic error in a laboratory analyzer, as recognized by Cembrowski’490.
Response to Arguments
Applicant's arguments filed 05/14/2026 have been fully considered but they are not persuasive.
Applicant argues that: The explicit recitation that collection is performed by a clinical chemistry or hematology analyzer analyzing a biological specimen elevates the collecting step beyond mere data gathering to a physical technical act on a specific class of instruments.
Applicant’s arguments with respect to the rejection of the amended independent claims 1, 8, and 15 under 35 USC 101 have been fully considered but are not persuasive. Referring to the MPEP 2106.04(a)(2), Step 2A: whether a claim is directed to a judicial exception, “Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.” As described in further detail under the 35 USC 101 rejection above, the non-abstract additional elements of the independent claims are seen as either generally linking the use of the judicial exception to a particular technological environment or field of use; adding insignificant extra-solution activity to the judicial exception, i.e. necessary data gathering; or mere instructions to implement an abstract idea on a computer. In particular, the non-abstract additional elements regarding “collecting, by a laboratory analyzer, the analyte from the same patient in accord with the schedule, the laboratory analyzer is a clinical chemistry or hematology analyzer configured to analyze a biological specimen obtained from the patient” are seen as similar to “Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)” (See MPEP 5106.05(g)). Further, the non-abstract additional elements are not seen as integrating the claim as a whole into a practical application because the non- abstract additional elements are well understood, routine, and conventional activity that as shown by the recited references is widely prevalent or in common use in the relevant industry. As the amended claims 1, 8, and 15 both recite a judicial exception and are not integrated into a practical application the 35 USC 101 rejection is maintained.
Applicant argues that: The addition of the outpatient laboratory and clinical chemistry or hematology analyzer recitations creates a clear technical distinction from Taub, which discloses a personal wearable continuous glucose monitor requiring user-initiated fingerstick calibration, a materially different device, clinical context, and patient population than the claimed outpatient laboratory specimen scheduling system.
Applicant’s arguments with respect to claim(s) 1, 8, and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that: Additionally, the explicit definition of same season as falling within 29 calendar days of a next year from the calendar date of the first measurement directly overcomes the Examiner's strained mapping of Taub's hourly calibration windows to the claimed seasonal condition.
Applicant’s arguments with respect to claim(s) 1, 8, and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Johnson et al. (Johnson, Paul R., Shahram Shahangian, and J. Rex Astles. "Managing biological variation data: modern approaches for study design and clinical application." Critical Reviews in Clinical Laboratory Sciences 58.7 (2021): 493-512.) discloses methods for controlling biological variation in analytes using time of day (See Page 504).
Wyse et al. (Wyse, Cathy, et al. "Seasonal and daytime variation in multiple immune parameters in humans: Evidence from 329,261 participants of the UK Biobank cohort." Iscience 24.4 (2021).) discloses how immune parameters vary with season and daytime (See Abstract).
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 CARTER W FERRELL whose telephone number is (571)272-0551. The examiner can normally be reached Monday - Friday 10 am - 8 pm.
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/CARTER W FERRELL/Examiner, Art Unit 2857
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2857
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