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
Claims 1-27 are currently pending. No amendments were made.
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 6 and 19 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.
Claims 6 and 19 recite the term “it” in line 2. It is unclear what “it” is. Clarification is requested.
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 1-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of structural elements, including a display. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
access analyte measurement data and event data from the one or more memories;
determine a first time frame for which to display analyte measurement data as part of a graph;
identify a plurality of events within the event data that occurred within the first time frame;
determine, based on times associated with the plurality of events, whether a first set of the plurality of events are within a predetermined proximity in the graph having the first time frame; and
provide for display the graph containing one or more event indications corresponding to the plurality of events, wherein the first set of the plurality of events are combined to be represented by a first event indication in the graph if it is determined that the first set of the plurality of events are within the predetermined proximity, and wherein each of the one or more event indications are associated with an analyte measurement within the graph
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. The accessing and providing steps also describe a concept of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Thus, the claim is also drawn to Organizing Human Activity, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites provide for display the graph containing one or more event indications corresponding to the plurality of events, wherein the first set of the plurality of events are combined to be represented by a first event indication in the graph if it is determined that the first set of the plurality of events are within the predetermined proximity, and wherein each of the one or more event indications are associated with an analyte measurement within the graph, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The providing of the graph does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the provided graph, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of:
access analyte measurement data and event data from the one or more memories
The accessing step is a well-understood, routine and conventional (WURC) activity for those in the field of medical diagnostics. Further, the accessing step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same rationale applies to claim 14.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited one or more memories is configured to perform pre-solutional data gathering activity and post-solutional activity of storing data, the display is configured to perform insignificant extra-solution activity, and the one or more processors is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-13 and 15-27 add to the Abstract Idea as the claims recite mental processing steps.. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 14, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayter et al. ‘399 (US Pub No. 2022/0000399).
Regarding claim 1, Hayter et al. ‘399 teaches a system for displaying analyte measurements (Fig. 2A reader device 120 and [0056]) comprising:
a display (display 122 and [0062]);
one or more memories for storing analyte measurement data and event data (memory 225 and [0070]); and
one or more processors (processor 222 and [0071]) configured to:
access analyte measurement data and event data from the one or more memories (Fig. 3A step 304 and [0072], [0100]);
determine a first time frame for which to display analyte measurement data as part of a graph (Fig. 5B graphical display 514 and [0180]; “Graphical display 514 can also include time periods of any of the various ranges of analyte data associated with the meal event at 314 of method 300”);
identify a plurality of events (Fig. 3D meal events 352-n and [0161]) within the event data that occurred within the first time frame (meal cluster 354 and [0161]);
determine, based on times associated with the plurality of events, whether a first set of the plurality of events are within a predetermined proximity in the graph having the first time frame (Fig. 3D meal cluster 354 and [0160]-[0161]); and
provide for display the graph (Fig. 5B graphical display 514 and [0181]) containing one or more event indications (Fig. 5B food icon 516 and [0181]) corresponding to the plurality of events, wherein the first set of the plurality of events are combined to be represented by a first event indication in the graph if it is determined that the first set of the plurality of events are within the predetermined proximity (Fig. 3D meal cluster 354 and [0160]-[0161], [0180]-[0181]), and wherein each of the one or more event indications are associated with an analyte measurement within the graph (food icon 516 and [0181]).
Regarding claim 6, Hayter et al. ‘399 teaches wherein the first event indication includes a symbol indicating the number of events with which it is associated (Fig. 5B food icon 516 and [0181]; “meal events that are clustered together can be indicated as only one event”).
Regarding claim 14, Hayter et al. ‘399 teaches a method for displaying analyte measurements as the subject matter of claim 14 is analogous to the subject matter of claim 1.
Regarding claim 19, Hayter et al. ‘399 teaches wherein the first event indication includes a symbol indicating the number of events with which it is associated (Fig. 5B food icon 516 and [0181]; “meal events that are clustered together can be indicated as only one event”).
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.
Claims 2-5, 7, 8, 11, 15-18, 20, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. ‘399 in view of Zamanakos et al. ‘420 (US Patent No. 10,867,420 – previously cited).
Regarding claim 2 and 15, Hayter et al. ‘399 teaches a graphical display 514 can also include time periods of any of the various ranges of analyte data associated with the meal event at 314 of method 300 ([0180]).
Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to:
identify a first user input as corresponding to a command for the graph to transition from the first time frame to a second time frame, wherein the second time frame is a shorter period of time than the first time frame;
determine that the set of events within the graph in the second time frame are outside of the predetermined proximity; and
in response to the first user input, automatically provide for display the graph in the second time frame, wherein the set of events are displayed in connection with the graph as at least two separate event indications.
Zamanakos et al. ‘420 teaches the one or more processors (Col. 57 lines 39-46) are further configured to:
identify a first user input as corresponding to a command for the graph to transition from the first time frame to a second time frame (Col. 25 lines 9-12, the patient is able to determine status over time, also see figure 14 depicting different time periods along with patterns, also see Col. 27 lines 5-23 the user is able to select or activate what to display), wherein the second time frame is a shorter period of time than the first time frame (Col. 32 lines 35-37, the time frame can be selected by default or by the patient, which time period is displayed in time frame);
determine that the set of events within the graph in the second time frame are outside of the predetermined proximity (Col. 35 lines 26-30, determines patterns or repeating occurrences, event scan be meal or exercise col. 41 lines 7-18); and
in response to the first user input, automatically provide for display the graph in the second time frame (Col. 27 lines 5-23 the user is able to select or activate what to display), wherein the set of events are displayed in connection with the graph as at least two separate event indications (Col. 35 lines 26-30, determines patterns or repeating occurrences, event scan be meal or exercise col. 41 lines 7-18 also see col. 40 lines 40-51, also see Figure 21 displays set of events in connection with graph, also see col. 39 lines 63-67 - col. 40 lines 1-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 to include identifying a first user input as corresponding to a command for the graph to transition from the first time frame to a second time frame, wherein the second time frame is a shorter period of time than the first time frame; determining that the set of events within the graph in the second time frame are outside of the predetermined proximity; and in response to the first user input, automatically providing for display the graph in the second time frame, wherein the set of events are displayed in connection with the graph as at least two separate event indications as Zamanakos et al. ‘420 teaches that this will aid in providing dynamic reporting functionally that can identify important information and dynamically present a report about the important information that highlights important findings to the user (Abstract).
Regarding claim 3, Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to:
identify a second user input as corresponding to a command for the graph to transition from the first time frame to a third time frame, wherein the third time frame is a longer period of time than the first time frame;
determine that one or more additional events within the graph in the third time frame are within of the predetermined proximity of the set of events; and
in response to the second user input, automatically provide for display the graph in the third time frame, wherein the set of events and the additional events are displayed in connection with the graph as a single combined event indication.
Zamanakos et al. ‘420 teaches the one or more processors (Col. 57 lines 39-46) are further configured to:
identify a second user input as corresponding to a command for the graph to transition from the first time frame to a third time frame (Col. 25 lines 9-12, the patient is able to determine status over time, also see figure 14 depicting different time periods along with patterns, also see Col. 27 lines 5-23 the user is able to select or activate what to display), wherein the third time frame is a longer period of time than the first time frame (Col. 32 lines 35-37, the time frame can be selected by default or by the patient, which time period is displayed in timeframe);
determine that one or more additional events within the graph in the third time frame are within of the predetermined proximity of the set of events (Col. 35 lines 26-30, determines patterns or repeating occurrences, event scan be meal or exercise col. 41 lines 7-18); and
in response to the second user input, automatically provide for display the graph in the third time frame (Col. 27 lines 5-23 the user is able to select or activate what to display), wherein the set of events and the additional events are displayed in connection with the graph as a single combined event indication (Col. 35 lines 26-30, determines patterns or repeating occurrences, event scan be meal or exercise col. 41 lines 7-18 also see col. 40 lines 40-51, also see Figure 21 displays set of events in connection with graph, also see col. 39 lines 63-67 - col. 40 lines 1-14, also see Figure 35 where single day traces are portrayed one above another and illustrate pattern over analyzed time frame).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 to include identifying a second user input as corresponding to a command for the graph to transition from the first time frame to a third time frame, wherein the third time frame is a longer period of time than the first time frame; determining that one or more additional events within the graph in the third time frame are within of the predetermined proximity of the set of events; and in response to the second user input, automatically providing for display the graph in the third time frame, wherein the set of events and the additional events are displayed in connection with the graph as a single combined event indication as Zamanakos et al. ‘420 teaches that this will aid in providing dynamic reporting functionally that can identify important information and dynamically present a report about the important information that highlights important findings to the user (Abstract).
Regarding claims 4 and 17, Hayter et al. ‘399 teaches wherein the single combined event indication is associated with a single analyte measurement (Fig. 3D meal cluster 354 and [0160]-[0161]).
Regarding claims 5 and 18, Hayter et al. ‘399 teaches wherein the events within the set of events are associated with different times (Fig. 3D meal events 352-1, 352-2, 352-3, 352-4 and [0161]).
Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the first event indication is placed within the graph at a position corresponding to a median time period between the different time periods.
Zamanakos et al. ‘240 teaches wherein the first event indication is placed within the graph at a position corresponding to a median time period between the different time periods (Col. 50 lines 19-27, stacking icons for events the method is capable of averaging events also see claim 5 can average amount of time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first event indication of Hayter et al. ‘399 to include being placed within the graph at a position corresponding to a median time period between the different time periods as Zamanakos et al. ‘240 teaches that this will aid in the user visualizing the amount of each administered (Column 50 Lines 19-21).
Regarding claims 7 and 20, Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to:
identify user input selecting a particular event indication displayed with the graph; and
in response to the selection the particular event indication, providing for display additional information relating to the one or more events associated with the event indication, wherein the additional information includes a trend graph of analyte measurements for each of the one or more events.
Zamanakos et al. ‘240 teaches the one or more processors are further configured to:
identify user input selecting a particular event indication displayed with the graph (Col. 50 Lines 27-44 the user can hover over icons to receive additional information on the event); and
in response to the selection the particular event indication, providing for display additional information relating to the one or more events associated with the event indication (Col. 50 Lines 27-44 the user can hover over icons to receive additional information on the event), wherein the additional information includes a trend graph of analyte measurements for each of the one or more events (Col. 26 lines 61- Col. 27 lines 1-2, can determine patterns in glucose traces).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 to include identifying user input selecting a particular event indication displayed with the graph; and in response to the selection the particular event indication, providing for display additional information relating to the one or more events associated with the event indication, wherein the additional information includes a trend graph of analyte measurements for each of the one or more events as Zamanakos et al. ‘240 teaches that this will aid in obtaining additional detail in a displayed report (Column 50 Lines 28-31).
Regarding claims 8 and 21, Hayter et al. ‘399 teaches wherein each trend graph displays a range of analyte measurements corresponding to predetermined periods of time before and after each of the one or more events (Fig. 5B shows that analyte measurements, as shown by the excursion indicator 408, before and after the one or more events, indicated by food icons 516.).
Regarding claims 11 and 25, Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to:
compare a most-recent analyte measurement to one or more threshold values; and
provide for display, within the graph, a current measurement indication having a color, wherein the color is based on the comparison of the analyte measurement with the one or more threshold values.
Zamanakos et al. ‘240 teaches wherein the one or more processors (Column 57 Lines 39-46) are further configured to:
compare a most-recent analyte measurement to one or more threshold values (Claim 1; compare signal traces and identify whether greater than threshold criterion); and
provide for display, within the graph, a current measurement indication having a color, wherein the color is based on the comparison of the analyte measurement with the one or more threshold values (Column 5 Lines 15-18; first color for a signal trace and second color for the signal trace above threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 to include comparing a most-recent analyte measurement to one or more threshold values; and providing for display, within the graph, a current measurement indication having a color, wherein the color is based on the comparison of the analyte measurement with the one or more threshold values as Zamanakos et al. ‘240 teaches this will aid in data visualization (Column 5 Lines 12-15).
Claims 9, 10, 12, 13, 22, 23, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. ‘399 in view of Harper et al. ‘704 (US Pub No. 2011/0193704 – previously cited).
Regarding claims 9 and 22, Hayter et al. ‘399 teaches wherein the one or more processors are further configured to:
identify a sensor that is configured to provide the analyte measurements (Fig. 1 sensor 104 and [0060]).
Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to:
determine a period of time for which the sensor will remain operation; and
provide for display a sensor-life indication in the same display as the graph, wherein the sensor-life indication includes a number indicating the period of time for which a sensor will remain operational, and wherein the sensor life indication is color-coded to indicate the unites of the represented by the number.
Harper et al. ‘704 teaches determining a period of time for which the sensor will remain operational ([0107], sensor life indicator); and
providing for display a sensor-life indication in the same display as the graph, wherein the sensor-life indication includes a number indicating the period of time for which a sensor will remain operational ([0106], [0107], sensor indicator on display), wherein the sensor life indication is color-coded to indicate the units of time represented by the number ([0107], the display can be color coded).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 to include determining a period of time for which the sensor will remain operation; and providing for display a sensor-life indication in the same display as the graph, wherein the sensor-life indication includes a number indicating the period of time for which a sensor will remain operational, and wherein the sensor life indication is color-coded to indicate the unites of the represented by the number as Harper et al. ‘704 teaches that this will aid in determining if/when the current sensor needs to be replaced ([0106]).
Regarding claims 10 and 23, Hayter et al. ‘399 in view of Harper et al. ‘704 teaches all of the elements of the current invention as mentioned above except for wherein the number is surrounded by a plurality of ticker marks corresponding to the units of the period of time represented by the number.
However, it appears that the device of Hayter et al. ‘399 in view of Harper et al. ‘704 would operate equally well with the sensor-life number displayed as well as alerts the user (see 35 U.S.C. 101 rejection for claims 9 and 22 above). It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor life number of Hayter et al. ‘399 in view of Harper et al. ‘704 to be displayed with a plurality of ticker marks because it appears to be arbitrary design consideration which fails to patentably distinguish over Hayter et al. ‘399 in view of Harper et al. ‘704.
Regarding claims 12 and 26, Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to: determine if the one or more processors are in communication with an operational sensor, and wherein the current measurement indication pulsates if the one or more processors are in communication with the operational sensor.
Harper et al. ‘704 teaches the current measurement indication pulsates if the one or more processors are in communication with an operational sensor ([0106], [0111]; flashing and fading of the battery icon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 to include determining if the one or more processors are in communication with an operational sensor, and wherein the current measurement indication pulsates if the one or more processors are in communication with the operational sensor as Harper et al. ‘704 teaches that this will aid in determining if/when the current sensor needs to be replaced ([0106]).
Regarding claims 13 and 27, Hayter et al .’399 teaches wherein the one or more processors are further configured to:
identify a user selection of a particular point within the graph provided for display ([0148], [0153]); and
determine an analyte measurement associated with the particular point ([0153]).
Hayter et al. ‘399 in view of Harper et al. ‘704 teaches all of the elements of the current invention as mentioned above except for wherein the one or more processors are further configured to:
provide for display a color-coded analyte measurement value, wherein the color corresponds to the relation of the analyte measurement value to the one or more threshold values.
Harper et al. ‘704 teaches providing for display a color-coded analyte measurement value, wherein the color corresponds to the relation of the analyte measurement value to the one or more threshold values ([0107], the display can be color coded).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more processors of Hayter et al. ‘399 in view of Harper et al. ‘704 to include providing for display a color-coded analyte measurement value, wherein the color corresponds to the relation of the analyte measurement value to the one or more threshold values as Harper et al. ‘704 teaches that this will aid in determining if/when the current sensor needs to be replaced ([0106]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. ‘399 in view of Cabrera Jr. et al. ‘559 (US Pub No. 2018/0042559).
Regarding claim 24, Hayter et al. ‘399 teaches all of the elements of the current invention as mentioned above except for wherein the graph provided for display includes an enlarged point associated with the most recent analyte measurement, and wherein the enlarged point is configured to pulsate.
Cabrera Jr et al. ‘559 teaches wherein the graph provided for display includes an enlarged point associated with the most recent analyte measurement (Fig. 31 dot 3126 and [0318]), and wherein the enlarged point is configured to pulsate ([0318]; “The dot 3126 is surrounded by a faded ring which in some embodiments can pulsate at the same rate and be rendered in the same style as the faded ring 3119 of the analyte indicator 3118.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the graph of Hayter et al. ‘399 to include an enlarged point associated with the most recent analyte measurement, and wherein the enlarged point is configured to pulsate as Cabrera Jr et al. ‘559 teaches that this will aid in indicating the current analyte value and to draw attention ([0319]).
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791