DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 10, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “modulo 29” in claims 3, 10, and 17 is used by the claim to mean “time period of 29 days,” while the accepted meaning is “a mathematical operation that returns the remainder of the division of two number.” The term is indefinite because the specification does not clearly redefine the term. Further, claims 3, 10, and 17 are indefinite because It is unclear from the language of the claim what terms are being operated on by modulo. Modulo is a mathematical Claims that depend on the above rejected claims are also rejected under 35 U.S.C. 112(b) or 35 .S.C. 112 (pre-AIA ), Second paragraph. operation that typically operates on two numbers, however the claims only recite “module 29”, therefor it is unclear what variable module is acting upon. For the purposes of examination the limitation “within modulo 29 days” shall be interpreted as requiring that the measurements used are within 29 days of each other. This rejection could be overcome by amending the claim language to clarify what variables module is acting upon.
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 1-3, 5-10, 12-17, and 19-20 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 a request to schedule a future measurement of an analyte at some time in the future;
determining 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 specified number of days window, the future measurement 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,
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.
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 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, nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, “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 specified number of days window, the future measurement 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”, 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, nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, “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, nothing in the claim language precludes the Step(s) from practically being performed in the mind. For example, “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” 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 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.
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.
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); and Glauser et al. (US 20200393476 A1).
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” and “collecting the analyte” can be viewed as a field of use, 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 specimen collection scheduler,” “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 2-3, 5-7, 9-10, 12-14, 16-17, and 19-20 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 2-3, 5-7, 9-10, 12-14, 16-17, and 19-20 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) 1-3, 6-10, 13-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taub et al. (US 20120108931 A1) in view of Cembrowski et al. (US 20160370394 A1).
Regarding Claims 1, 8, and 15. Taub teaches:
A method comprising:
receiving a request to schedule a future measurement of an analyte at some time in the future (See Fig. 13, Fig. 14, para[0006], para[0013] – para[0014], and para[0141] – para[0145]: Providing a user the option to select a time for obtaining a calibration sample of the user's blood to obtain a calibration value. A first user-determined calibration mode includes a user-configurable calibration time. According to this mode, a user can schedule their upcoming calibrations.);
responsive to confirming the time delta is within a specified number of days window (See para[0149]: calibrations are required to occur at one or more scheduled calibration time(s). For example, preset intervals may be provided, e.g., that calibration occurs at 24 hours, 48 hours, and 72 hours after sensor insertion, etc.),
the future measurement is within a same specified time of day window as the immediately previous measurement (See Fig. 13, para[0006], para[0141]: For example, exemplary optimal times to calibrate can include in the morning before leaving the house for work, or at night before going to bed.), and
the future measurement is within a same season as the immediately previous measurement (See para[0149]: calibrations are required to occur at one or more scheduled calibration time(s). For example, preset intervals may be provided, e.g., that calibration occurs at 24 hours, 48 hours, and 72 hours after sensor insertion, etc.) (Examiner note: based on a broadest reasonable interpretation of season, calibrations that occur within 24 hours of each are interpreted as being within the same season.),
adding the future measurement of the analyte to a schedule at the proposed time (See Fig. 14, para[0148] – para[0149]: After providing the notifications, the system provides the user with the option of scheduling calibration (1450). If the user elects to calibrate, such calibration is scheduled (1460).); and
collecting, by a laboratory analyzer, the analyte from the same patient in accord with the schedule (See Fig. 6 and para[0104] – para[0105]: If conditions permit (or require) calibration, and calibration is called for or expected in accordance with a calibration schedule, or user initiated, a calibration attempt may be requested (612). Calibration "attempt" for purposes hereof means that a reference measurement is used or evaluated for calibration purposes.).
Taub is silent as to the language of:
determining 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 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 Taub determining 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 Taub, 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 2, 9, and 16. Taub teaches:
The method of claim 1, the system of claim 8, or the machine readable storage device of claim 15,
wherein the same season is within 29 days of the immediately previous measurement (See para[0149]: calibrations are required to occur at one or more scheduled calibration time(s). For example, preset intervals may be provided, e.g., that calibration occurs at 24 hours, 48 hours, and 72 hours after sensor insertion, etc.).
Regarding Claims 3, 10, and 17. Taub teaches:
The method of claim 2, the system of claim 9, or the machine readable storage device of claim 16,
wherein the same season is further defined as within modulo 29 days of the immediately previous measurement, wherein modulo retains days and removes years (See para[0149]: calibrations are required to occur at one or more scheduled calibration time(s). For example, preset intervals may be provided, e.g., that calibration occurs at 24 hours, 48 hours, and 72 hours after sensor insertion, etc.).
Regarding Claims 6, 13, and 20. Taub teaches:
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 (See para[0134]: Similarly, if a requested calibration is failed, for any number of reasons (e.g., glucose outside of desirable range for calibration) the system will not accept the blood glucose measurement as a valid calibration and will not provide sensor readings and may prompt the user to perform additional calibration attempts.).
Regarding Claims 7 and 14. Taub 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 (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.).
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 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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taub 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 Taub, 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 Taub et al. (US 20120108931 A1) in view of 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. Taub 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 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.
Nevertheless Cembrowski’490 teaches:
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 (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 Taub 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 Taub, because using a Dahlberg variation would have helped to determine systematic error in a laboratory analyzer, as recognized by Cembrowski’490.
Claim(s) 5, 12, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taub et al. (US 20120108931 A1) in view of Cembrowski et al. (US 20160370394 A1) as applied to claims 1, 8, and 15 above, and further in view of Parvin et al. (US 20070198213 A1).
Regarding Claims 5, 12, and 19. Taub 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,
wherein the specified number of days window is an integer multiple of seven days.
Nevertheless Parvin teaches:
wherein the specified number of days window is an integer multiple of seven days (See para[0441], para[0569], and para[0581]: The application calculates a … weekly … mean, median and standard deviation of the patient data population generated by the main laboratory. The application maintains a rolling 7-day (7D), 30-day (30D), six months and lot to date (LTD) mean, median, standard deviation. Equilibration includes a twelve week period in which both QC data and patient data are collected and analyzed by the Biometric model.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taub wherein the specified number of days window is an integer multiple of seven days such as that of Parvin. Parvin teaches, “Recognizing and allowing for hourly, daily and seasonal variations enables the system to use both normal and abnormal patient test results” (See para[0047]). One of ordinary skill would have been motivated to modify Taub, because using measurements within 7 day time window would have helped to compensate for daily variation in patient data, as recognized by Parvin.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Glauser et al. (US 20200393476 A1) discloses scheduling analyzer to be used in validating a diagnostic test (See Abstract and para[0044]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine T. Rastovski can be reached at (571)270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARTER W FERRELL/Examiner, Art Unit 2863
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2863