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 .
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 §§ 706.02(l)(1) - 706.02(l)(3) 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).
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Claims 1-3, 6-9, 11-13, 16-18, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims 1, 1, 3, 1, 1, 6, 1, 1, 1, 3, 1, 6, 1, 13 respectively of U.S. Patent No. 11957490 as shown below:
Application 18/611,642
US Patent 11957490
Claim 1
Claim 1
Claim 2
Claim 1
Claim 3
Claim 3
Claim 6
Claim 1
Claim 7
Claim 1
Claim 8
Claim 6
Claim 9
Claim 1
Claim 11
Claim 1
Claim 12
Claim 1
Claim 13
Claim 3
Claim 16
Claim 1
Claim 17
Claim 6
Claim 18
Claim 1
Claim 20
Claim 13
Although the claims at issue are not identical, they are not patentably distinct from each other because, the subject matters are same and the claims of the instant application are an obvious variant of the claims of Patent No. 11957490. Furthermore, scope of the claims in the instant application are met and encompassed by the corresponding claims of the Patent US 11957490.
The apparent difference in the claims’ recitation as listed above is simply emanating from the way or choice of wording used in reciting the claims, but the material recited therein is considered substantively equivalent, met and encompassed by the respective claims of the Patent.
Subject matter of method claims e.g. 1-3, 6-9 of the instant application are substantively similar to device claims 1, 1, 3, 1, 1, 6, 1 respectively of the Patent. Thus, although wording is different these claims are considered substantively similar to the respective matched claims of U.S. Patent No. 11957490. The apparent difference in the claims’ recitation as listed above is simply emanating from the way or choice of wording used in reciting the claims, but the material recited therein is considered substantively equivalent, met and encompassed by the respective conflicting claims of the Patent # 11957490.
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 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 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 of this title, 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 1-9, 11-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Soren et al. (Plougmann, Søren, Ole K. Hejlesen, and David A. Cavan. "DiasNet—a diabetes advisory system for communication and education via the internet." International Journal of Medical Informatics 64.2-3 (2001): 319-330; hereinafter Soren).
Regarding claim 1, Soren discloses a processor-implemented method (It is implemented in JAVA according to the client/ server principle and can run both as an ordinary application on a standard PC, and as an Internet JAVA applet using a standard browser; see fig. 1, “DiasNet System”, page 321) comprising: displaying, via a graphic user interface, historical physiological data of a person obtained during a historical time period, and one or more historical events that occurred during the historical time period (see Fig. 3 with p. 322-324, section 3.2 "Data section". "As the first step in using the system, blood glucose, meal and insulin data have to be entered. This is done via the Data section [ ... ] A prototype module which interfaces blood glucose meters has been developed thereby reducing the need for keying in data".
see p. 325, "Future section", "To experiment with data the patient simply clicks in the Simulation section on the day of interest, and this day is then automatically inserted in the Future section for further experiments. The layout of the Future section is identical to the Simulation section [ ... ]"; see Fig. 5 in view of Fig. 4, "The lower thin grey and upper bold grey curves show the blood glucose prediction before and after these adjustments, respectively."; As previously taught in "Simulation Section 3.3", meals and injection events are represented as bars in the graph view.);
receiving a change to at least one attribute of a historical event of the one or more historical events (see p. 325, "Future section", "In the Future section meals and insulin injections can be changed by simply using the mouse to drag the bars"); and
displaying, via the graphic user interface, adjusted historical physiological data indicating an estimated change to the historical physiological data that is resulted from the change to the at least one attribute of the historical event (see Fig. 5 with p. 325, "Future section", "In the Future section meals and insulin injections can be changed by simply using the mouse to drag the bars, and immediately seeing the resulting blood glucose prediction. As an example, the problem on November 22 has been addressed by increasing the meal at lunch time (from 30 to 50 g, as shown in the figure) and decreasing regular insulin at 17:00.The thin grey and bold grey curves show the blood glucose prediction before and after these adjustments, respectively.").
Claim 1 thus differs from Soren in that receiving a change to at least one attribute of a historical events, such as a timing of the historical event, e.g. a marker for an event, of the one or more historical events, is adjusted from a first position in the historical time period to a second position in the historical time period, the second position corresponding to a time point in the historical time period. In other words: the user may drag a marker to a different point in time, thus simulating the effects of a past meal or injection being hypothetically shifted to an earlier or later point in time. Soren mentions only the adjustment of meal or injection doses for the sake of exploring the outcome of the blood glucose level, but not adjusting a meal or injection time.
In the given context, allowing the user to also experiment with the timing of meal intake and injection is deemed to present a straightforward further option. The timing of meal intake has an impact on the glucose curves, as also derivable from p. 325, left-hand column, first full paragraph, "Later that same day around 22:00 an additional hypoglycemic episode is predicted by the system, which can be explained by the shift in time of the evening snack, compared to the previous days", emphasis added. The glucose prediction model thus takes the time of a meal into account. Experimenting also with such timing variable in the "Future section" of Soren by means of adjusting the event bars in Soren by the already disclosed dragging interaction is thus straightforward to consider and implement. In fact, looking at Fig. 5, the dragging cursor comprising arrows in horizontal and vertical directions, and the fact that the time and doses is displayed accordingly, already provides strong hints into that direction.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the invention of Soren with the teaching of dragging the bars on the display to immediately see the result of glucose prediction, e.g. within a time frame of noon to 17.00 pm (see section 3.4 “Future Section”), to obtain, receiving a change to at least one attribute of a historical event, such as user input being adjusted from a first position in the historical time period to a second position in the historical time period, the second position corresponding to a time point in the historical time period, because, extending the drag gesture using a mouse from one position to two positions on the historical time period is an obvious option to try for one of ordinary skill in the art, choosing from a finite number of identified, predictable solutions (seeing results of one point in time or two points in time), with a reasonable expectation of success.
Regarding claim 2, Soren discloses the processor-implemented method of claim 1, wherein the at least one attribute of the historical event comprises: a quantity of an insulin dose or a meal; an intensity of an exercise; a duration of the meal or the exercise; a content of the meal; a timing of the historical event (see claim 1 rejection above which explains an attribute being a change in timing of the historical event); or any combination thereof.
Regarding claim 3, Soren discloses the processor-implemented method of claim 1, wherein the change to the at least one attribute of the historical event is received via: a voice command; an input through a touch screen or a touch pad; an input through a mouse; an input through a keyboard; an input through a motion sensing system; or any combination thereof (Fig. 5 with p. 325, "Future section", "In the Future section meals and insulin injections can be changed by simply using the mouse to drag the bars, and immediately seeing the resulting blood glucose prediction.". Soren thus also teaches adjusting a marker (a bar) by "dragging" input with "immediate" presentation of the respective simulation output).
Regarding claim 4, Soren discloses the processor-implemented method of claim 1, further comprising: receiving a new event to add to the historical time period, the new event selected from a menu of events (Other therapeutic experiments can also be performed. Utilising the ‘New item’ functionality shown to the right in Fig. 6, the patient can illustrate the effect of various insulin types: for example using ultra-short acting insulin (Lispro) instead of short acting (regular) insulin, page 325, section 3.4, ¶0003, fig. 5).
Regarding claim 5, Soren discloses the processor-implemented method of claim 4, further comprising: displaying adjusted historical physiological data indicating an estimated change to the historical physiological data that is resulted from the new event (Other therapeutic experiments can also be performed. Utilising the ‘New item’ functionality shown to the right in Fig. 6, the patient can illustrate the effect of various insulin types: for example using ultra-short acting insulin (Lispro) instead of short acting (regular) insulin, page 325, section 3.4, ¶0003, fig. 5).
Regarding claim 6, Soren discloses the processor-implemented method of claim 1, wherein displaying the adjusted historical physiological data comprises: dynamically displaying the adjusted historical physiological data indicating the estimated change to the historical physiological data that is resulted from the change as the change is being made (see p. 325, "Future section", "To experiment with data the patient simply clicks in the Simulation section on the day of interest, and this day is then automatically inserted in the Future section for further experiments. The layout of the Future section is identical to the Simulation section [ ... ]"; see Fig. 5 in view of Fig. 4, "The lower thin grey and upper bold grey curves show the blood glucose prediction before and after these adjustments, respectively."; As previously taught in "Simulation Section 3.3", meals and injection events are represented as bars in the graph view.
see Fig. 5 with p. 325, "Future section", "In the Future section meals and insulin injections can be changed by simply using the mouse to drag the bars, and immediately seeing the resulting blood glucose prediction. As an example, the problem on November 22 has been addressed by increasing the meal at lunch time (from 30 to 50 g, as shown in the figure) and decreasing regular insulin at 17:00.The thin grey and bold grey curves show the blood glucose prediction before and after these adjustments, respectively."
Also see claim 1 rejection above).
Regarding claim 7, Soren discloses the processor-implemented method of claim 1, further comprising: receiving a request to adjust the historical time period; and displaying historical physiological data of the person during the adjusted historical time period, and one or more historical events occurred during the adjusted historical time period (see p. 325, "Future section", "To experiment with data the patient simply clicks in the Simulation section on the day of interest, and this day is then automatically inserted in the Future section for further experiments. The layout of the Future section is identical to the Simulation section [ ... ]"; see Fig. 5 in view of Fig. 4, "The lower thin grey and upper bold grey curves show the blood glucose prediction before and after these adjustments, respectively."; As previously taught in "Simulation Section 3.3", meals and injection events are represented as bars in the graph view.
see p. 325, "Future section", "In the Future section meals and insulin injections can be changed by simply using the mouse to drag the bars").
Regarding claim 8, Soren discloses the processor-implemented method of claim 1, wherein displaying the historical physiological data and the one or more historical events occurred during the historical time period comprises: overlaying the one or more historical events over the historical physiological data (Fig. 5 with p. 325, "Future section", "In the Future section meals and insulin injections can be changed by simply using the mouse to drag the bars, and immediately seeing the resulting blood glucose prediction.". Soren thus also teaches adjusting a marker (a bar) by "dragging" input with "immediate" presentation of the respective simulation output.).
Regarding claim 9, Soren discloses the processor-implemented method of claim 1, wherein displaying the historical physiological data and the one or more historical events occurred during the historical time period comprises: plotting the one or more historical events apart from the historical physiological data (see p. 325, "Future section", "To experiment with data the patient simply clicks in the Simulation section on the day of interest, and this day is then automatically inserted in the Future section for further experiments. The layout of the Future section is identical to the Simulation section [ ... ]"; see Fig. 5 in view of Fig. 4, "The lower thin grey and upper bold grey curves show the blood glucose prediction before and after these adjustments, respectively."; As previously taught in "Simulation Section 3.3", meals and injection events are represented as bars in the graph view.).
Regarding claim 11, Soren discloses a system comprising:
one or more memory devices; and one or more processors communicatively coupled with the one or more memory devices, wherein the one or more processors are configured to perform operations (It is implemented in JAVA according to the client/ server principle and can run both as an ordinary application on a standard PC, and as an Internet JAVA applet using a standard browser; see fig. 1, “DiasNet System”, page 321) comprising:
displaying, via a graphic user interface, historical physiological data of a person obtained during a historical time period, and one or more historical events that occurred during the historical time period; receiving a change to at least one attribute of a historical event of the one or more historical events; and displaying, via the graphic user interface, adjusted historical physiological data indicating an estimated change to the historical physiological data that is resulted from the change to the at least one attribute of the historical event (regarding this part of the claim, although wording is different, the material is substantively similar to the independent claim 1above).
Regarding claims 12-18, although wording is different, the material is substantively similar to the claims 2-8 respectively as discussed above.
Allowable Subject Matter
Claims 10, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims [Note: Terminal Disclaimer is required to obviate the Double Patenting rejection set forth in the Office Action].
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, none of the prior arts of record, either alone or in a reasonable combination found disclosing the limitation,
the processor-implemented method of claim 1, further comprising: responsive to a value of the historical physiological data being outside of a range, suggesting an action to keep physiological data of the person within the range; and displaying adjusted historical physiological data indicating an estimated change to the historical physiological data that is resulted from the action.
Regarding system claim 19, although wording is different, the material is substantively similar to the method claim 10 discussed above.
Conclusion
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/NURUN FLORA/Primary Examiner, Art Unit 2619