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 Status
Claims 2-21 are pending.
Claims 2-21 are examined on the merit.
Priority
The instant application claims priority to US Provisional Application 61/174,436, filed 04/30/2009. As such, the effective filing date assigned to each of claims 2-21 is 04/30/2009.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 through 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Malave et al. (US20020193679A1) and further in view of Harmon et al. (US20060095225A1).
Regarding claims 2, 9, and 16, Malave discloses a communication station is for use with a medical device and a processing device, where the medical device is an infusion pump, analyte monitor, continuous glucose monitor, glucose meter, or the like, and the processing device is a computer [0008]; reading on limitations of a method of analyzing continuous analyte sensor data associated with a host, wherein the continuous analyte sensor data is representative of analyte levels of the host.
Malave further discloses that the communication station PC software provides several data display and print options for the user to better analyze and sort the data downloaded for each patient. For instance, the PC software provides user-selectable displays (e.g., reports, and the like) and printouts of infusion pump, glucose meter and glucose monitor (i.e., sensor) data in accordance with the display screens and reports [0082]; reading on limitations of providing, on a user interface, one or more user interface features to be selected through user interaction with the one or more user interface features.
Malave further discloses that the glucose meter stores data including time stamped glucose readings [0081] and that the report may also contain data from a different download date and time to fill the 91-day period. Alternatively, the report may only cover a specific period or fraction within the downloaded data or may include more or less than 91 days [0082]; reading on limitations of receiving, through the user interface, a user selection in response to the user interaction with the one or more user interface features.
Malave further discloses that the 2 Week Modal Day report, which provides the glucose meter data from a specified 14 days so that it is plotted vs. time on a single day scale so that a user may visualize trends over 2-week period as it relates to specific times of day [0106]; reading on limitations of a selection of a desired time period during which the continuous analyte sensor data associated with the host was received;
Malave further discloses that the Current Setting report which has two main components: a listing of the current infusion pump settings and a graph of the current basal profile and the current infusion pump settings include information on: Auto Off (OFF or the hour setting if on, e.g. 10 hr) and Time Display (12 or 24 hr) [0115]; reading on limitations of a selection of a duration of an analysis time period from a plurality of durations.
Malave further discloses that the desired time periods comprise a number of analysis time periods each having the same selected duration [0108] FIG. 22 (A-B);
Malave further discloses that the report depicts Glucose Monitor data (including meter calibration & reference data) for the specified 4-day period and that the four days of data immediately prior to (and including) the specified download date will be displayed. Malave further discloses that in alternative embodiments, the user may specify other time periods [0108] FIG 22 (A-B); reading on limitations of a selection of a first analysis time period and a second analysis time period from the number of analysis time periods, wherein the first analysis time period and the second analysis time period are nonconsecutive time periods.
Malave further discloses that the report includes Continuous Glucose Measurement data (preferably, displayed on a 4-day time scale) [0108] FIG. 22(A-B); reading on limitations of accessing a first plurality of analyte readings associated with the host for the first analysis time period, wherein each of the first plurality of analyte readings is indicative of an analyte level of the host at a respective time during the first analysis time period; based on the user selection, accessing a second plurality of analyte readings associated with the host for the second analysis time period, wherein each of the second plurality of analyte readings is indicative of an analyte level of the host at a respective time during the second analysis time period.
Malave further discloses that in FIG. 22 (A-B) The top portion of the report includes the Sensor Data section that displays a 4-day continuous graph of Glucose Monitor data integrated with meter calibration and reference points. Malave further discloses that the bottom side portion includes a Glucose Goals pie chart that has three sections that show the percentage of glucose meter readings that were above, within, and below range for the selected 4 day period. The bottom side portion also has a tabular statistical data section (sensor data summary) that will include the Hours of Sensor data displayed, the Mean Glucose Level for the selected period, the Maximum and Minimum Glucose level for the selected period, the Standard Deviation of the glucose Sensor data, and the average number of meter readings per day [0109]; reading on limitations of determining a relationship between the first plurality of analyte readings and the second plurality of analyte readings, wherein the relationship indicates an improvement or deterioration of analyte control of the host between the first analysis time period and the second analysis time period and generating a performance report indicating the improvement or deterioration, wherein: the performance report includes a presentation of each of the first analysis time period and the second analysis time period divided over a plurality of intervals; and the presentation comprises superposition of the first plurality of analyte readings and the second plurality of analyte readings for each interval of the first analysis time period and the second analysis time period.
Further regarding claims 2, 9, and 16, Malave discloses that the report depicts Glucose Monitor data for the specified 4-day period and that the four days of data immediately prior to the specified download date will be displayed. Malave further discloses that in alternative embodiments, the user may specify other time periods [0108] FIG 22 (A-B).
Malave does not expressly discloses that the two nonconsecutive time periods are separated by at least one other analysis time period within the desired time period.
Harmon discloses a computer-implemented method of visualizing time-dependent data loading at least a first set of time-dependent data generating an output from the computer such that clinically significant excursions in the at least first set of time-dependent data are visually identified, where the at least first set of time-dependent data may be sorted according to a plurality of configurable time periods. Harmon further discloses visualizing time-dependent data of at least two time-dependent sets of data is also disclosed. The method comprises loading at least a first and second set of time-dependent data into the computer. The method also comprises calculating a percent change between the first and second set of time-dependent data (abstract).
Harmon further discloses a user-instructed report to use an encounter comparison (for example, non-consecutive time periods separated by at least one other analysis time period within the desired time period), where the user identifies the start date for the analysis of first and second date (FIG. 3). Harmon further discloses setting number of time slots to generate the report. Harmon further discloses that the selections which activate these functions may be selected at any time and be changed interactively. Harmon further discloses that number of time slots correspond to the number of possible readings during a 24-hour period of blood glucose testing (for example time periods having the same selected duration) [0042-0043].
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard to Malave and Harmon, Examiner concludes that the combination of Malave and Harmon represents simple substitution of one known element for another. Both Malave and Harmon are directed to analyte monitoring. Malave disclosed user selection of desired time periods and durations with a 4-day report during set time durations. Malave further stated that the user may specify other time periods. In the same field of research, Harmon provided the variations in the first and second time period i.e., consecutive vs. nonconsecutive, for the purpose of having more meaningful less noisy data. One ordinary skilled in the art could have substituted one known element, 4-day time period of Malave, for another, the nonconsecutive time period of Harmon, and the result of the substitution would have yielded predictable results.
Regarding claims 3, 10, and 17, Malave discloses that the report includes Continuous Glucose Measurement data (preferably, displayed on a 4 day time scale.), Modal Day display of Glucose Monitor data displayed on a 24 hour scale [0108]; reading on limitations of a duration of the first and the second analysis time periods is one of: one or more hours, one or more days, one or more weeks, one or more months, one or more quarters, or one or more years.
Regarding claims 4, 11, and 18, Malave discloses that the bottom side portion also has a tabular statistical data section that will include the Hours of Sensor data displayed, the Mean Glucose Level for the selected period, the Maximum and Minimum Glucose level for the selected period, the Standard Deviation of the glucose Sensor data, and the average number of meter readings per day and a Glucose Goals pie chart that has three sections that show the percentage of glucose meter readings that were above, within, and below range for the selected 4 day period [0109]; reading on limitations of determining the relationship between the first plurality of analyte readings and the second plurality of analyte readings comprises: determining a first metric using the first plurality of analyte readings for the first analysis time period and a second metric using the second plurality of analyte readings for the second analysis time period; comparing the first and the second metrics; and determining the relationship based on the comparing.
Regarding claims 5, 12, and 19, Malave discloses a Glucose Goals pie chart that has three sections that show the percentage of glucose meter readings that were above, within, and below range for the selected 4 day period [0109]; reading on limitations of wherein the relationship indicates an improvement or a deterioration of the second metric in relation to the first metric.
Regarding claims 6, 13, and 20, Malave disclose The bottom side portion also has a tabular statistical data section that will include the Hours of Sensor data displayed, the Mean Glucose Level for the selected period, the Maximum and Minimum Glucose level for the selected period, the Standard Deviation of the glucose Sensor data, and the average number of meter readings per day [0109]; reading on limitations of wherein each of the first and the second metrics is an analyte variability metric.
Regarding claims 7, 14 and 21, Malave discloses that each day's sensor data will be uniquely colored, and a specific day's color in the ‘Sensor Data’ section will match the corresponding day color in the ‘Modal Day’ graph section. In addition, the hypoglycemic and hyperglycemic glucose limits (set in the User Preferences screen) will be indicated as dashed lines [0108]; reading on limitations of the analyte variability metric represents analyte variability in a respective one of the first or second plurality of analyte readings for the first or second analysis time period.
Regarding claims 8 and 15, Malave discloses each day's sensor data will be uniquely colored, and a specific day's color in the ‘Sensor Data’ section will match the corresponding day color in the ‘Modal Day’ graph section. In addition, the hypoglycemic and hyperglycemic glucose limits (set in the User Preferences screen) will be indicated as dashed lines [0108]; reading on limitations of wherein the analyte variability metric is one of: a mean analyte level of the respective one of the first or second plurality of analyte readings for the first or second analysis time period, a standard deviation of the respective one of the first or second plurality of analyte readings for the first or second analysis time period, a trend of the respective one of the first or second plurality of analyte readings for the first or second analysis time period, a percentage and/or quantity of days during the first or second analysis time period in which the respective one of the first or second plurality of analyte readings were within a target analyte range, or a percentage and/or quantity of days within the first or second analysis time period in which the host used a continuous analyte sensor system, used for generating the respective one of the first and the second plurality of analyte readings, for a minimum time.
Response to Applicant’s Arguments
Applicant states:
Malave provides no disclosure explicit or implicit-that suggests the selection of nonconsecutive time periods. Malave fails to teach or suggest, "the user selection comprising [...1a selection of a first analysis time period and a second analysis time period from the number of analysis time periods, wherein the first analysis time period and the second analysis time period are nonconsecutive time periods separated by at least one other analysis time period within the desired time period", as recited in independent claims 2, 9, and 16. Applicant therefore respectfully submits that independent claims 2, 9, and 16, along with the dependent claims thereon, are at least allowable over Malave for these reasons.
It is respectfully submitted that this is not persuasive. The amendments to claims necessitated a new round of art rejection. As discussed above, Malave in view of Harmon disclose the limitations of instant claims.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over (respectively) claim 1 and 7 of U.S. Patent No. 11,437,141 in view of Malave, and further in view of Harmon. Claim 7 of '141 teaches the limitations of claims 3, 10 and 17, and claim 1 of '141 teaches all but the followings:
"the performance report includes a presentation ..."
“the performance report further includes a direct comparison ...", as recited in instant claims 1, 9 and 16.
“… nonconsecutive time periods separated by at least one other analysis time period within the desired time period” as in instant claims 1, 9, and 16.
“the user selection comprising: a selection of a desired time period during which the continuous analyte sensor data associated with the host was received; a selection of a duration of an analysis time period from a plurality of durations, wherein the desired time period comprises a number of analysis time periods each having the same selected duration; and a selection of a first analysis time period and a second analysis time period from the number of analysis time periods”;
“wherein the relationship indicates an improvement or deterioration of analyte control of the host between the first analysis time period and the second analysis time period; and generating a performance report indicating the improvement or deterioration, as recited in instant claims 1, 9 and 16.
As explained above, Malave in view of Harmon teaches these limitations (Malave: 0106—0109; Figs. 17, 19A—D, 21A—B and 22A-B) and ([0106-0109] [0115], FIG. 22 (A-B)) and (Harmon: abstract, [0042-0043], and FIG. 3 and 4).
An invention would have been obvious to one of ordinary skill in the art if some teaching would have led that person to combine prior art reference teachings to arrive at the claimed invention. Prior to the time of invention, said practitioner would have followed the teachings of Malave, regarding different ways of displaying blood glucose data over time, and combined these various depictions with the invention of ‘141. Given that both '141 and Malave in view of Harmon are directed to blood glucose measurement analysis, management and visualization systems, said practitioner would have readily predicted that the combination would successfully result in a system as claimed. The inventions are therefore prima facie obvious.
Response to Applicant’s Arguments
Applicant states that the amendments presented herein render the double patenting rejection moot.
It is respectfully submitted that this is not persuasive. As stated above, Malave in view of Harmon disclose limitations of instant claims. As such, the nonstatutory double patenting rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GHAZAL SABOUR whose telephone number is (703)756-1289. The examiner can normally be reached M-F 7:30-5:00.
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, Larry D. Riggs can be reached at (571) 270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.S./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686