Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The current application has the effective filing date of 08/07/2006 according to the priority chain on the record.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 14 of U.S. Patent No. 12,245,839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent teach an invention that wholly encompasses the invention disclosed in the current application, see underlined limitation as follows:
App. 19/029,877
Pat’12,245,839 (Pat’839
1. A method for displaying a graphical representation of monitored glucose levels, the method comprising:
receiving glucose data from a predetermined time period from a continuous glucose sensor, wherein the continuous glucose sensor is configured to be subcutaneously positioned such that at least a portion of the continuous glucose sensor data is determined based on the continuous glucose sensor being in fluid contact with analytes of the user;
detecting a predetermined rate of increase in a glucose level in the glucose data;
associating a time of the predetermined rate of increase in the glucose level with a first meal event;
detecting a second predetermined rate of increase in a glucose level in the glucose data;
associating a time of the second predetermined rate of increase in the glucose level with a second meal event, the second meal event being a different type of meal event than the first meal event;
storing the first meal event, the time associated with the first meal event, and a first glucose level associated with the time of the first meal event in a database;
storing the second meal event, the time associated with the second meal event, and a second glucose level associated with the time of the second meal event in the database;
displaying a graphical representation of the first meal event, the second meal event, the first glucose level, and the second glucose level.
1. A method for displaying a graphical representation of monitored glucose levels, the method comprising:
retrieving a meal schedule associated with a user, wherein the meal schedule includes one or more meal types, and wherein the meal schedule is for a predetermined time period;
retrieving a monitored glucose level associated with the predetermined time period, wherein the monitored glucose level is based on continuous glucose sensor data from a continuous glucose sensor, and wherein the continuous glucose sensor is configured to be subcutaneously positioned such that at least a portion of the continuous glucose sensor data is determined based on the continuous glucose sensor being in fluid contact with analytes of the user;
detecting a predetermined rate of increase in glucose level for a predetermined time period based in part on the monitored glucose level, wherein the predetermined rate of increase is associated with a predefined meal event, and wherein the predetermined rate of increase meets a predetermined threshold;
identifying, in the meal schedule, a meal event that corresponds to the predefined meal event;
arranging, in the graphical representation, the predetermined rate of increase in glucose level based on the one or more meal types of the meal schedule, wherein the arranging includes visually aligning the identified meal event with the predetermined rate of increase in glucose level; and
displaying the graphical representation on a display device.
5. The method of claim 1, wherein the predetermined time period comprises at least two time periods associated with the one or more meal types.
6. The method of claim 5, wherein the monitored glucose level comprises a plurality of monitored glucose levels and the one or more meal types comprises at least two meal types, and wherein arranging the monitored glucose level comprises arranging each glucose level of the monitored glucose levels based on the at least two meal types.
11. A system for displaying a graphical representation of monitored analyte levels, the system comprising:
a processor;
computer memory readable by the processor; and
computer-readable instructions stored in the computer memory, wherein the instructions are configured to cause the processor to:
receive glucose data from a predetermined time period from a continuous glucose sensor, wherein the continuous glucose sensor is configured to be subcutaneously positioned such that at least a portion of the continuous glucose sensor data is determined based on the continuous glucose sensor being in fluid contact with analytes of the user;
detect a predetermined rate of increase in a glucose level in the glucose data;
associate a time of the predetermined rate of increase in the glucose level with a first meal event;
detect a second predetermined rate of increase in a glucose level in the glucose data; associate a time of the second predetermined rate of increase in the glucose level with a second meal event, the second meal event being a different type of meal event than the first meal event;
store the first meal event, the time associated with the first meal event, and a first glucose level associated with the time of the first meal event in a database;
store the second meal event, the time associated with the second meal event, and a second glucose level associated with the time of the second meal event in the database; and
display a graphical representation of the first meal event, the second meal event, the first glucose level, and the second glucose level.
9. A system for displaying a graphical representation of monitored analyte levels, the system comprising:
one or more processors;
computer memory; and
computer-readable instructions stored in the computer memory, wherein the instructions are configured to cause the one or more processors to:
retrieve a meal schedule associated with a user, wherein the meal schedule includes one or more meal types, and wherein the meal schedule is for a predetermined time period;
retrieve a monitored glucose level associated with the predetermined time period, wherein the monitored glucose level is based on continuous glucose sensor data from a continuous glucose sensor, and wherein the continuous glucose sensor is configured to be subcutaneously positioned such that at least a portion of the continuous glucose sensor data is determined based on the continuous glucose sensor being in fluid contact with analytes of the user;
detect a predetermined rate of increase in glucose level for a predetermined time period based in part on the monitored analyte level, wherein the predetermined rate of increase is associated with a predefined meal event, and wherein the predetermined rate of increase meets a predetermined threshold; identify, in the meal schedule, a meal event that corresponds to the predefined meal event;
arrange, in the graphical representation, the predetermined rate of increase in glucose level based on the one or more meal types of the meal schedule, wherein the arranging includes visually aligning the identified meal event with the predetermined rate of increase in glucose level; and display the graphical representation on a display device.
13. The system of claim 9, wherein the predetermined time period comprises at least two time periods associated with the one or more meal types.
14. The system of claim 13, wherein the monitored glucose level comprises a plurality of monitored glucose levels and the one or more meal types comprises at least two meal types, and wherein arranging the monitored glucose level comprises arranging each glucose level of the monitored glucose levels based on the at least two meal types.
Claim 1 is rejected by Pat’ 839 claim 6 (incorporating claims 1 and 5).
Claim 11 is rejected by Pat’839 claim 14 (incorporating claims 9 and 13).
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter-abstract idea under mental processes and mathematical relationships grouping without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claim 1 and 11 each discloses a method and a system; and thus, the independent claims and their corresponding dependent claims also fall under one of the four patent eligible categories.
To Step 2(a) prong 1:
Claim 1 recites:
A method for displaying a graphical representation of monitored glucose levels, the method comprising:
receiving glucose data from a predetermined time period from a continuous glucose sensor, wherein the continuous glucose sensor is configured to be subcutaneously positioned such that at least a portion of the continuous glucose sensor data is determined based on the continuous glucose sensor being in fluid contact with analytes of the user;
detecting a predetermined rate of increase in a glucose level in the glucose data;
associating a time of the predetermined rate of increase in the glucose level with a first meal event;
detecting a second predetermined rate of increase in a glucose level in the glucose data;
associating a time of the second predetermined rate of increase in the glucose level with a second meal event, the second meal event being a different type of meal event than the first meal event;
storing the first meal event, the time associated with the first meal event, and a first glucose level associated with the time of the first meal event in a database;
storing the second meal event, the time associated with the second meal event, and a second glucose level associated with the time of the second meal event in the database;
displaying a graphical representation of the first meal event, the second meal event, the first glucose level, and the second glucose level.
Claim 1, is directed to a method receiving glucose data, calculating a rate of change/increase of the glucose data, comparing said rate of change/increase to predetermined threshold, so as to identify a meal event, repeat the above steps, and displaying the accumulated detected glucose data and identified meal events. The claim under the broadest reasonable interpretation, recites a judicial exception: an abstract idea under the grouping of mental processes. Specifically, the italicized portions above, which include the steps of receiving, detecting, associating, and displaying; are all steps which can be done in a person’s mind via series of mental observations, or by using pen and paper. A person can receive glucose levels by reading glucose data and using a glucose sensor. A person can perform simply mathematical calculations to determine the rate of increase of the glucose levels and using judgement to associated the change/increase to a meal event. Lastly, a person can then use pen and paper to write down the glucose data and the associated meal event and associated times. Accordingly, claim 1 fall under the abstract idea grouping of mental processes and/or mathematical calculations.
With regard to independent claim 11, these two independent claims also fall under the abstract idea grouping of mental processes under the same rationale as discussed to claim 21 above.
As for dependent claims 2-10 and 12-20, the recited limitations are directed to naming the various meal types, setting time period for monitoring, and arranging the displayed data as a profile. These are all regarded as mental processes under BRI, because a predetermined period and meal event types (i.e. breakfast, lunch, dinner, etc.) can be visually observed and determined via mental processes.
Under Step 2(a) prong 2: The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. An example of a practical integration of a medical treatment step has been noted in Classen Immunotherapies Inc. v. Biogen IDEC 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011), in which the claimed treatment step (e.g. immunization step) is meaningful as the particular immunization schedule lowers immunization risk.
It has been established that recitation of insignificant extra solution activity do not qualify as integration of a judicial exception/abstract idea into a practical application; see MPEP 2106.05(g). Here, the independent claims 1 and 11 additional recites the additional features: (subcutaneous) continuous glucose sensor, processor(s), computer memory/database, and computer-readable instructions; these additional features are regarded as mere tools to define the field of technology of the instant application. The recited steps of retrieving and arranging analyte levels do not improve the functioning of the recited computer, i.e. processor and/or memory.
The limitation “(subcutaneous) continuous glucose sensor” recited in the claims are regarded as tools for a data gathering step, and falling under insignificant pre-solution and post-solution activity under MPEP 2106.05(g).
As for claims 9-10 and 18-19, although these claims recite “optimal medication administration profile”, these claims do not actually recite therapeutic steps or optimizing medication (schedule) steps; but merely arranging displayed data based other types of retrieved data (e.g. “medication administration profiles”, “rates of increase of the glucose levels” etc.).
The judicial exception of the independent claims are not integrated into a practical application because independent claims 21, 29 and 36 do not disclose an actual diagnosis or treatment for a particular disease under MPEP 2106.05(e).
Under Step 2b: The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-20 require the structural limitations: (subcutaneous) continuous glucose sensor, processor(s), computer memory/database, and computer-readable instructions. However, these additional limitations do not add more to the judicial exception which would amount to significantly more than an abstract idea. In fact, using these recited limitations to receive the data retrieval, associating data to event, and arrangement of data for display is considered routine and conventional in the art.
Under the Berkheimer guidance, the following reference sets the standard for well-understood, routine and conventional activities:
Worthington et al. US 6379301 B1 discloses using a analyte monitoring system (having processor and memory) as shown in Figs. 1-3, which retrieves analyte levels, and displays glucose levels arranged based to meal times. Worthington also discloses a fluid delivery system, see Figs. 6A-7.
Galley et al. US 6544212 discloses a system for glycemic control including a glucose sensor, a GUI to retrieve glucose levels, meals time, and an insulin delivery unit; see Abstract and Fig.5.
Mault et al. US 2003/0208113 discloses a portable system for glycemic control including a glucose analyte sensor, an electronic device (including processor and memory) and an insulin delivery device; see Figs. 1-2.
Rosenthal US 2004/0181132 A1 discloses a portable system for monitoring and retrieving analyte levels comprising a glucose analyte sensor and a portable device; see Fig. 1. Rosenthal further discloses arranging analyte level based on retrieved meal times, see Fig. 9A.
Brauker et al. US 2005/0192557 also discloses a portable system for monitoring and retrieving analyte levels comprising a transdermal analyte sensor, a portable controller and insulin delivery device; see Figs. 1 and 4A-4B.
(All references have been previously cited on the record on this and parent applications.)
Accordingly, viewed as a whole, neither the combination of elements, nor the implicitly disclosed elements of amount to significantly more than the judicial exception. Claims 1-20 are rejected under 35 USC 101 for patent-ineligible subject matter.
Claim Interpretation
With regard to claims 1 and 11, the limitation “detecting a predetermined rate of increase in a glucose level in the glucose data” is taken to require calculating rate of change or slope of glucose levels, and detecting when said rate of change or slope meets a “predetermined rate of increase.”
Claim Rejections - 35 US C § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fox et al. US 2005/0113653 A1 (hereinafter “Fox”) and in view of Nitzan et al. US 2007/0033074 A1 (hereinafter “Nitzan”).
Regarding claim 1, Fox discloses a method for displaying a graphical representation of monitored glucose levels, the method comprising:
receiving glucose data from a predetermined time period from a continuous glucose sensor, wherein the continuous glucose sensor is configured to be subcutaneously positioned such that at least a portion of the continuous glucose sensor data is determined based on the continuous glucose sensor being in fluid contact with analytes of the user (see [0043-0044, 0047-0047] and Figs. 1-2, sensor set 102 comprises a subcutaneous glucose sensor for continuous monitoring of glucose level, the detected glucose data is transmitted for processing at processor108/monitor 104);
detecting a predetermined rate of increase in a glucose level in the glucose data ([0085] continuously detecting glucose data, and comparing it to predetermined rate/slope threshold, e.g. rate of increase; [0064, 0090, 0094] different threshold levels are associating with ad different type of events. In here, a first predetermined rate/slope is taken to encompass “a (first) predetermined rate of increase”);
associating a time of the predetermined rate of increase in the glucose level with a first meal event ([0020, 0072-0078] “Monitor for anticipating hyperglycemic incident”, a meal is a hyperglycemic event and see [0095: 1st sentence] “Characteristic monitors and infusion devices can use event markers that place tags in the data for events the user experiences (e.g., but not limited to, meals, exercise, and high or low blood glucose).”; events are associated with time see Figs. 6A-6D);
detecting a second predetermined rate of increase in a glucose level in the glucose data ([0085] continuously detecting glucose data, and comparing it to predetermined rate slope threshold levels, e.g. rate of increase; [0064, 0090, 0094] different threshold levels are associating with ad different type of events. In here, a second predetermined rate/slope is taken to encompass “a second predetermined rate of increase”);
associating a time of the second predetermined rate of increase in the glucose level with a second meal event ([0020, 0072-0078] “Monitor for anticipating hyperglycemic incident”, a meal is a hyperglycemic event and see [0095: 1st sentence] “Characteristic monitors and infusion devices can use event markers that place tags in the data for events the user experiences (e.g., but not limited to, meals, exercise, and high or low blood glucose).”; events are associated with time see Figs. 6A-6D);
storing the first meal event, the time associated with the first meal event, and a first glucose level associated with the time of the first meal event in a database ([0023, 0103-0104] stored and retrospective display of blood glucose and event marker); and
storing the second meal event, the time associated with the second meal event, and a second glucose level associated with the time of the second meal event in the database ([0023, 0103-0104] stored and retrospective display of blood glucose and event marker).
Fox discloses retrospective display of event markers with associated glucose measurement and times (exemplary as shown in Figs. 6A-6D); but Fox does not disclose that the second meal event being a different type of meal event than the first meal event; and displaying a graphical representation of the first meal event, the second meal event, the first glucose level, and the second glucose level.
Nitzan, another prior art reference in the analogous field of continuous glucose detection ([0127, 0249] subcutaneous glucose sensor), recording event markers associated with glucose measurements ([0099: last 3 sentences] user set glucose measurement ranges for each meal marker or meal event; [0101] user logs meal marker or meal event, e.g. breakfast, lunch, dinner; [0132] device automatically identifies a meal type based on carbohydrate entry and time of marked event), arranging the monitored analyte levels and meal schedules for graphical display ([0012, 0070] arranging detected glucose measurements, and various event makers; see Figs. 5-6 and also see Fig. 42: chart 1350 is a visual arrangement of glucose with corresponding meal markers; also see [0249:8th sentence] “[t]he overlay glucose by meal charts 1350 align the time of meal for each of the days within the selected time period”). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Fox to include event markers for identifying different meal types and to include retrospective display for graphical display of the first meal event, the second meal event, the first glucose level, and the second glucose level in view of Nitzan; the motivation for doing so is because the graphical display of glucose readings with respect to meal types, and meal times provides the advantages of allowing a medical practitioner to identify pre-prandial, and post-prandial glucose trends to optimize treatment (Nitzan: [0009]).
Regarding claim 2, Fox modified discloses the method of claim 1, wherein the one or more meal types is one of breakfast, lunch, or dinner. (See modification to claim 1 above, Fox [0015, 0018] teaches setting different slope threshold associated with various event markers; and [0101, 0132] Nitzan discloses logging carbohydrate events and device automatically identifying a meal type based on time of event marker, the meal types include breakfast, lunch, or dinner.)
Regarding claim 3, Fox modified discloses the method of claim 1, wherein the predetermined time period is a time period associated with the one or more meal types. (see rejection to claim 1 above, Nitzan [0132] discloses associated time period with a meal type)
Regarding claim 4, Fox modified discloses the method of claim 1, Nitzan further discloses wherein the predetermined time period comprises at least two time periods associated with the one or more meal types ([0131] user selects a time frame for each meal type; [0135, 0139, 0146] before and after each of breakfast, lunch and dinner). It would have been obvious to further modify Fox to set a time range for threshold changes for identifying before and after each type of meal in view of Nitzan, because this would allow more comprehensive review of glucose changes with respect to meal times.
Regarding claims 5 and 6, Fox modified discloses the method of claim 1, Nitzan further discloses comprising retrieving a meal schedule for the predetermined time period, wherein at least one of the types of the first meal event and the second meal event is associated with the meal schedule and wherein the meal schedule for the predetermined time period includes one or more time periods associated with one or more of a breakfast, a lunch, and a dinner. ([0132-0133] “For example, if for the breakfast time period input box 421 6:00 am-10:00 am is selected, the DDMS may look for a meal event during this specified timeframe.”; [0249: 6th sentence] “[a]lso included are overlay glucose by meal charts 1350, retrieving meal chart 1350”, which include overlays for each of the meal events). It would have been obvious to further modify Fox to retrieve a meal schedule for the predetermined time period, set a time range for threshold changes for identifying before and after each type of meal in view of Nitzan, because this would allow more comprehensive review of glucose changes with respect to meal times.
Regarding claim 7, Fox modified discloses the method of claim 1, wherein the predetermined time period is one or more of a three day predetermined time period, a seven day predetermined time period, and less than a fourteen day predetermined time period. (Fox: [0107-0108] total time is shown as 36 hours in Fig. 6C. However, the amount of total time for monitoring is dependent on capability of storage according to [0045]. Thus, it is a mere design choice to expand monitoring predetermined time period to at least three days and less than fourteen days by expanding memory capability)
Regarding claim 8, Fox modified discloses the method of claim 6, further comprising arranging, in the graphical representation, the predetermined rate of increase in glucose level based on the one or more meal types of the meal schedule, wherein the arranging includes visually aligning the identified meal event with the predetermined rate of increase in glucose level. (see rejection to claim 1, Fox discloses arranging glucose level and meal based on times see Figs. 6A-6D; Nitzan: Fig.5-6)
Regarding claims 9 and 10, Fox modified discloses the method of claim 1, Nitzan further discloses determining an optimal medication administration profile based on one or more medication administration profiles, the rates of increase of the glucose levels, and a comparison between a number of the rates of change of the glucose level over the predetermined time period exceeding a predetermined number (Nitzan: [0138-0139]). Fox further teaches wherein the graphical representation includes the optimal medical administration profile ([0152] “. In addition, other statistics such as insulin delivery statistics and carbohydrates consumed statistics may be presented in the glucose meal event and time event table 520 along with selected blood glucose statistics for the selected adjustable analysis timeframes.”; also see [0165]). It would have been obvious to a person of ordinary skill in the art at the time of invention to further modify Fox in view of Nitzan to include determining optimal medication profile and also displaying the medication with respect to glucose and meals; the motivation for doing so is to provide a complete picture of glucose, meals and insulin for a particular patient.
Regarding claim 11, Fox teaches a system (Fig. 1: system 100; see [0043]) for displaying a graphical representation of monitored analyte levels, the system comprising: a processor (Fig.1: 108); computer memory (Fig.1: 110) readable by the processor; and computer-readable instructions stored in the computer memory ([0103]). This claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 1 above.
Regarding claim 12, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 2 above.
Regarding claim 13, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 3 above.
Regarding claims 14-15, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claims 5-6 above.
Regarding claim 16, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 7 above.
Regarding claims 17-18, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claims 8 and 9 above.
Regarding claim 18, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 9 above.
Regarding claim 19, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 10 above.
Regarding claim 20, this claim is rejected by Fox and Nitzan under the same rationale as discussed to claim 4 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 25, 2026
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