DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Final Office Action is in Reply to the arguments/amendment after non-final rejection (hereinafter “Response”) dated 12/28/2025. Claim(s) 1-6 and 8-13 are presently pending. Claim(s) 1-6 and 8-13 is/are amended. Claim(s) 7 is/have been cancelled.
Response to Amendment
The rejection of claim(s) 1-8 under 35 U.S.C. 112(b) is/are withdrawn in light of the submitted amendment to the claims.
The rejection of claim(s) 1-7 and 10-13 under 35 U.S.C. 103 is/are withdrawn in light of the submitted amendment to the claims and in response to applicant(s) arguments, which are persuasive, however, as necessitated by applicant(s) amendment, which introduced newly claimed subject matter, a new rejection of the claims under 35 U.S.C. 103 as being unpatentable over Dilanni (WO2006/104806A2) in view of Yang (CN108261585A), Guerrini (U.S. Pat. Pub. No. 2016/0089494 A1), Grosman (U.S. Pat. Pub. No. 2019/0321553 A1), Bengtsson (U.S. Pat. Pub. No. 2019/0228853 A1), and Haidar (U.S. Pat. Pub. No. 2020/0197605 A1) is presented, wherein Bengtsson and Haidar are relied upon to teach the newly claimed subject matter of the applicants amended claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-6, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni (WO2006/104806A2) in view of Yang (CN108261585A), Guerrini (U.S. Pat. Pub. No. 2016/0089494 A1), Grosman (U.S. Pat. Pub. No. 2019/0321553 A1), Bengtsson (U.S. Pat. Pub. No. 2019/0228853 A1), and Haidar (U.S. Pat. Pub. No. 2020/0197605 A1).
Regarding claim 1, Dilanni discloses a bilaterally driven, wearable fluid pump (200) which may be used to infuse insulin as part of an artificial pancreas (200, see [0028-0029] and [0040]), comprising: an infusion module (fluid drive mechanism 250), including: a drug storage unit (fluid reservoir 230); a screw (threaded drive rod 252) connected to a piston (plunger 236) and a driving wheel (drive wheel 256) provided with wheel teeth (see Fig. 2-13), the driving wheel drives the screw to move by rotation, pushing the piston, provided in the drug storage unit, forward (see Fig. 2-13, [0029] and [0032-0040]); a driving unit (drive engaging member 262) cooperating with the driving wheel (see Fig. 2-13 and [0036]), the driving unit includes at least two driving portions (264a, 264b), the driving unit pivots around a pivot shaft (pivot point 162, see [0036], ln 1-2), driving the driving portions in different directions, thus pushing the wheel teeth located on the driving wheel respectively, and rotating the driving wheel (see Fig. 2-13 and [0036-0040]); a power unit (assembly of batteries 210 and linear actuator of Fig. 2 and 4-5, and [0034]) connected to the driving unit (via SMA wire portions 260a, 260b), outputting two forces in two directions on the driving unit, making the driving unit pivot in two directions around the pivot shaft (see Fig. 2 and 4-5, and [0034-0040]); and a program module (circuit board 290, comprising control circuitry of [0037-0040]), connected to the infusion module (see Fig. 1, [0029], ln 5-12, and [0037-0040]), the forces output by the power unit are controlled by the program module, thereby controlling the infusion module to infuse insulin required ([0037-0040]).
Dilanni fails to teach that the bilaterally driven artificial pancreas comprises a detection module configured to continuously detect a real-time blood glucose level, wherein the program module is connected to the detection module.
Yang exhibits a closed loop artificial pancreas system (see Fig. 1-9) comprising a wearable patch fluid pump (patch pump 2) comprising an infusion module (portion of patch pump 2 not including the processor 202) integrated with a program module (processor 202 of the patch pump) in a similar manner to the fluid pump of Dilanni, and a detection module (dynamic blood glucose monitoring system 1) configured to continuously detect a real-time blood glucose level (see Fig. 1-9 and English Translation, pg. 5, para. 1, lines 3-4). Yang further teaches that the detection module may be connected to the program module (directly, as in the embodiment of Fig. 3 and 9, wherein the devices are integrated into a single structure, or via a wireless medium, as in the embodiments of Fig. 1 and 4-6, and 2 and 7-8) in order to supply the program module with blood glucose data, whereupon the program module may control the infusion module to infuse insulin as required based upon the provided data from the detection module (see English Translation, pg. 5, para. 4 – pg. 8, para. 3). Yang teaches that such an integrated system enables closed-loop (automatic) control of the infusion process (see English Translation, pg. 5, para. 4 – pg. 8, para. 3), allowing the artificial pancreas to automatically respond to changing blood glucose conditions within the patient, even during sleep periods wherein the patient is not able to consciously take action, thereby improving the accuracy and reliability of the treatment administered by the artificial pancreas (English Translation, pg. 1, line 19 – pg. 2, ln 8, and pg. 4, lines 6-21).
Based on the teachings of Yang, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bilaterally driven, wearable fluid pump of Dilanni to cooperate with a detection module of the type taught by Yang as part of a bilaterally driven closed-loop artificial pancreas, such that the assembly of Dilanni further comprises a detection module configured to continuously detect a real-time blood glucose level, and such that the program module is connected to the detection module, in a manner taught by Yang, in order to thereby create a functional artificial pancreas with closed-loop (automatic) control of the infusion process, allowing the artificial pancreas to automatically respond to changing blood glucose conditions within the patient, even during sleep periods wherein the patient is not able to consciously take action, thereby improving the accuracy and reliability of the treatment administered by the artificial pancreas, as described by Yang (English Translation, pg. 1, line 19 – pg. 2, ln 8, and pg. 4, lines 6-21).
Dilanni also fails to teach that and that the program module is imported a total daily dose algorithm and a current insulin infusion algorithm, and a force output of the power unit is controlled by the program module according to a calculation result of the current insulin infusion algorithm, thereby controlling the infusion module to infuse insulin required.
Yang further teaches that the program module (processor 202 of the patch pump) of such an artificial pancreas system as that of Dilanni may be configured with a closed-loop algorithm (English Translation, pg. 1, ln. 19 – pg. 2, ln 8, pg. 2, ln 26-27, and pg. 4, ln 6-16), such that the program module is imported a current insulin infusion algorithm (hypoglycemic infusion algorithm), and a force output of the power unit is controlled by the program module according to a calculation result of the current insulin infusion algorithm, thereby controlling the infusion module to infuse insulin required (English Translation, pg. 2, ln 11-20, pg. 3, ln 3-6, pg. 7, ln 6-13, and pg. 8, para. 1-3, wherein Yang discusses the process of adjusting the algorithms which are imported to and present within the processor 202 of the patch pump in order to enable the processor 202 to control the force output of the power unit, and thereby the amount of insulin delivered, in accordance with data supplied to the processor 202 concerning the condition of the patient).
Based on the teachings of Yang, and since Dilanni does not specify the technique by which the program module controls the power unit in order to thereby control the infusion module to infuse insulin required, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the program module of the bilaterally driven fluid pump of Dilanni such that the program module is imported a current insulin infusion algorithm, such that a force output of the power unit is controlled by the program module according to a calculation result of the current insulin infusion algorithm, thereby controlling the infusion module to infuse insulin required, as taught by Yang, as a matter of simply selecting a known and suitable technique of embodying the control scheme of a power unit similar to that of Dilanni, and applying the technique to the program module of Dilanni in order to improve upon this device by allowing it to operate in the same way as is described in Yang. See MPEP 2143(I)(C).
While Yang teaches the use of a current insulin infusion algorithm which drives the operation of the infusion module and which may be adjusted according to the physiological condition of the patient (English Translation, pg. 2-4, pg. 5, ln 30 – pg. 7, ln 13 and pg. 8, ln 1-19), Yang does not teach the use of a total daily dose algorithm as one variable factor of the current insulin infusion algorithm. It is, however, well known in the art that the insulin sensitivity of a patient, being the change in blood glucose per unit insulin administered, is a key component in determining the amount of infused insulin required by a patient during a treatment in order to obtain or maintain a target blood glucose value. As such, it is clear that insulin sensitivity is also a key component of current insulin infusion algorithms within the art such as that taught by Yang (see, for example, Guerrini, [0003-0016]). Further, it is known that the insulin sensitivity of a patient may change as a result of changing circumstances of the patient (Guerrini, [0024]). Grosman exhibits an insulin infusion device (104) similar to the device of Dilanni as modified by Yang (see above), the device comprising a program module (processor device 202) which calculates a basal rate setting (i.e. current insulin infusion rate) via imported control algorithms configured to enable closed-loop automatic control of insulin delivery by the device based upon measured blood glucose, in a manner similar to that described by Yang (see Grosman, [0025], [0031-0032], and [0043-0045]). Grosman teaches that the basal rate setting (output of the current insulin infusion algorithm) may be automatically recalculated on an ongoing basis by obtaining an updated insulin sensitivity of a patient ([0054]), in order to thereby achieve a more accurate control of a patient’s blood glucose (better glycemic outcome) within the euglycemic range ([0045] and [0054]). Grosman further teaches that the updated insulin sensitivity may be calculated based upon the average total daily dose (TDD) of insulin administered to a patient over a period of multiple days, as may be calculated by a total daily dose algorithm based upon infusion data stored in the device ([0045-0054] and [0059-0060]). Thus, taken together, Guerrini and Grosman teach that current insulin infusion algorithms, such as that of Yang, are known in the art to benefit from the use of a total daily dose algorithm of the kind taught by Grosman as a means to provide the current insulin infusion algorithm with updated insulin sensitivity data upon which the algorithm may more accurately calculate the amount of insulin needed by a patient during treatment. In other words, a total daily dose of the type taught by Grosman may serve as one variable factor of the current insulin infusion algorithm, pertinent to the insulin sensitivity factor portion of the algorithm. As such, based on these teachings, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the program module of the bilaterally driven fluid pump of Dilanni such that the program module is imported a total daily dose algorithm which may serve as one variable factor of the current insulin infusion algorithm, in the manner taught by Grosman, and to configure the program module to retain the infusion data necessary for calculation of an average total daily dose in the manner described by Grosman, thereby allowing the current insulin infusion algorithm to be fed automatically updating insulin sensitivity data upon which to provide a more accurate estimation of the amount of insulin necessary to control of a patient’s blood glucose to within the euglycemic range, as described by Grosman ([0045] and [0054]).
Finally, Dilanni fails to teach that the program module obtains an insulin dose infused per day by users, the insulin dose infused per day by users includes a total amount of daily infusion dose data, the total daily dose is obtained by calculating the total amount of daily infusion dose data in the previous two or more days according to the total daily dose algorithm, wherein the total daily dose is adopted a method of combining weighted average with a sliding data frame.
Grosman further teaches that the program module includes an automatic detection sub-module, and the program module obtains an insulin dose infused per day by users, wherein the insulin dose infused per day by users is automatically detected, stored and calculated by the automatic detection sub-module ([0045-0053], [0058], ln 11-13, and [0059-0060]), and wherein the insulin dose infused per day by users includes a total amount of daily infusion dose data ([0046] and [0053]). It would have been obvious to one of ordinary skill in the art to further incorporate these teachings of Grosman as part of the above modification of Dilanni as taught by Grosman. Grosman, however, does not give details concerning how the total daily dose may be calculated. Thus, one of ordinary skill in the art would be motivated to look to other references which may provide such details concerning insulin sensitivity factor and total daily does calculation in order to enable the teachings of Grosman to be implemented. Such references include Bengtsson, which teaches that the insulin sensitivity factor (ISF) of a patient may be calculated as a weighted average of recorded data calculated over a past estimate horizon (i.e. a sliding data frame), such as a few days, in order to screen out from the calculation events that are not representative of current physiological circumstances (such as non-adherence events, like lapses in insulin application) (see [0075-0076]) or to emphasize more recent data, which may be more relevant to current physiological circumstances (see [0189-0192]), thereby improving the accuracy of the insulin sensitivity factor calculation. Based on the teachings and example of Bengtsson, it would have been obvious to one of ordinary skill in the art to calculate the insulin sensitivity factor as a weighted average of recorded data over a past estimate horizon (sliding date frame) of several days, and it further follows that, for the same reasons of screening out from the calculation events that are not representative of current physiological circumstances and/or emphasizing more recently collected data that may be more relevant to current physiological circumstances, and in view of the teachings of Grosman (which relates the total daily dose and insulin sensitivity factor), one of ordinary skill in the art would have also found it obvious to calculate the total daily dose as a weighted average of recorded data using a sliding data frame of several days. Further, Haidar teaches that the total daily dose (TDD) of insulin for a patient may be accurately calculated based on recorded total and basal insulin delivery data over a sliding data frame of one or more days ([0031]). As such, it would further have been obvious to one of ordinary skill in the art to calculate the total daily dose of the above modification as a weighted average of recorded data using a sliding data frame of two or more days, as described by Haidar.
Regarding claim 2, Dilanni further discloses that the driving wheel includes at least two sub-wheels (258a, 258b, see Fig. 2 and [0033]).
Regarding claim 3, Dilanni further discloses that the driving wheel includes two sub-wheels (see in re claim 2), and the pivot shaft is disposed between the two sub-wheels (see Fig. 2-5 and [0036]), at least one of the driving portions (264a, 264b) is provided on each of both sides of the driving unit (see Fig. 5 and [0036]), and each of the sub-wheels is cooperated with a corresponding one of the driving portions (see Fig. 5 and 13, [0036], and [0038-0040]).
Regarding claim 5, Grosman further teaches that the program module includes an automatic detection sub-module, and the program module obtains an insulin dose infused per day by users, wherein the insulin dose infused per day by users is automatically detected, stored and calculated by the automatic detection sub-module ([0045-0053], [0058], ln 11-13, and [0059-0060]). It follows that such a configuration may be incorporated into the bilaterally driven closed-loop artificial pancreas of Dilanni as modified by Yang, Guerrini, and Grosman as part of the above modification in re claim 1 wherein the proposed combination is modified to include a total daily dose algorithm, and the program module is modified to retain the infusion data necessary for calculation of an average total daily dose in the manner described by Grosman (see in re claim 1).
Regarding claim 6, Grosman further teaches that the insulin dose infused per day by users includes a total amount of daily infusion dose data ([0046] and [0053]). It follows that such a configuration may be incorporated into the bilaterally driven closed-loop artificial pancreas of Dilanni as modified by Yang, Guerrini, and Grosman as part of the above modification in re claim 1 wherein the proposed combination is modified to include a total daily dose algorithm in the manner taught by Grosman, and the program module is modified to retain the infusion data necessary for calculation of an average total daily dose in the manner described by Grosman (see in re claim 1).
Regarding claim 10, Yang further teaches that in order to determine an ideal treatment plan for a user, an accurate judgement of the user’s physical condition, including whether the patient is asleep or exercising, is needed (English Translation, pg. 1, ln 19 – pg. 2, ln 8). As such, Yang teaches that variable factors of the control algorithms imported to the program module may include user's physical activity status, including general body stretching (posture), exercise, and sleep (English Translation, pg. 2-4 and pg. 5, ln 30 - pg. 7, ln 2, wherein such factors are measured and used to adjust the current insulin infusion algorithm – the hypoglycemia infusion algorithm – and other predictive algorithms). Yang further teaches that the user's physical activity status may be measured automatically by a motion sensor (101, 201) that is provided within the detection module or the infusion module (English Translation, pg. 8), which may automatically sense the users physical activity status and send the measured data to the program module, thereby contributing one of the variable factors of the current insulin infusion algorithm (hypoglycemia infusion algorithm) (English Translation, pg. 5, ln 30 – pg. 7, ln 13 and pg. 8, ln 1-19, wherein the motion sensor data is used to adjust both algorithms such that they are able to accurately recalculate the blood glucose value to reflect the actual condition of the patient, and thereby are able to accurately calculate an accurate dosage of insulin needed by the patient at a given time or predicted for the day). Based on these teachings of Yang, it would have been obvious to one of ordinary skill in the art to modify the bilaterally driven closed-loop artificial pancreas of Dilanni as modified by Yang, Guerrini, and Grosman according to claim 1 to further include a motion sensor as taught by Yang, which is provided in the detection module or the infusion module, and which is used to automatically sense user’s physical activity status and send this data to the program module as one of the variable factors of the current insulin infusion algorithm, as taught by Yang, such allowing for an accurate judgement of the user’s physical condition, including whether the patient is asleep or exercising, which is necessary for determining an ideal treatment plan, as described by Yang (English Translation, pg. 1, ln 19 – pg. 2, ln 8).
Regarding claim 11, Yang further teaches that the motion sensor includes a three-axis acceleration sensor (English Translation, pg. 2, ln 22 and pg. 5, ln 30). Such a motion sensor is incorporated into the bilaterally driven closed-loop artificial pancreas of Dilanni as modified by Yang, Guerrini, and Grosman in the above modification in re claim 10.
Regarding claim 12, both Dilanni and Yang teach that the program module and the infusion module may be connected to each other configured to form a single structure (see Dilanni, Fig. 1 and [0029], wherein the program module – circuit board 290 – and the infusion module – fluid drive mechanism 250 – are assembled together to form the fluid pump 200; and see Yang, Fig. 1-9, English Translation, pg. 5, para. 2 and pg. 8, para. 1-2, wherein the program module - processor 202 – and the infusion module – the remainder of patch pump 2 – are assembled together to form the patch fluid pump). Yang further teaches in one embodiment (Fig. 2 and 7-8) that the attached position on a skin of these two components may be different from an attached position of the detection module (see Yang, Fig. 2 and 7-8, English Translation, pg. 5, para. 2 and pg. 8, para. 1-2). It would therefore have been obvious in implementing the proposed combination in re claim 1 to provide the detection module such that the attached position on a skin of the program module and infusion module may be different from an attached position of the detection module, as exemplified by Yang, as merely an adoption of one of the several known means of providing a detection module according to the teachings of Yang.
Regarding claim 13, Yang further teaches that the detection module, the program module, and the infusion module may be connected together configured to form a single structure which is attached on only one position on a skin (see Fig. 3, English Translation, pg. 5, para. 3, and English Translation, pg. 8, para. 3). It would therefore have been obvious in implementing the proposed combination in re claim 1 to provide the detection module such that the attached position on a skin of the program module and infusion module may be different from an attached position of the detection module, as exemplified by Yang, as merely an adoption of one of the several known means of providing a detection module according to the teachings of Yang.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dilanni as modified by Yang, Guerrini, Grosman, Bengtsson, and Haidar according to claim 3, and in further view of Mahoney (U.S. Pat. Pub. No. 2003/0199824 A1).
Regarding claim 4, Dilanni as modified by Yang exhibits the bilaterally driven closed-loop artificial pancreas of claim 3. Dilanni fails to teach that the at least one driving portion on each of both sides of the driving unit is two driving portions, and the two driving portions on one of the sides of the driving unit are disposed up and down or left and right with respect to each other and the driving wheel.
Mahoney exhibits a fluid pump configuration for infusion of insulin to a patient, similar to that of Dilanni (see Fig. 1-14, [0003], and [0057-0059]), comprising a driving wheel (314) which is engaged by a pivoting driving unit (cam 374) which comprises a set of two driving portions in the form of palls (376, 378) that operate to turn the driving wheel for dispensing insulin to the patient in a similar manner to the configuration of Dilanni – that is, under the influence of a push/pull force imparted to the driving unit via an SMA wire linear actuator (350) (see Fig. 14, [0071-0084] and [0106-0111]). Mahoney teaches that the two driving portions are also disposed up and down relative to each other and the driving wheel within the frame of reference of Fig. 14 (see Fig. 14 and [0106-0111]). Mahoney teaches that the use of two driving portions configured in this manner allows the fluid pump to dispense insulin with increased flow rate resolution and slower minimum infusion rate (i.e. minimum screw rotation rate) as compared to a configuration using only one driving portion to engage the driving wheel (see [0094], [0107], ln 16-21, and [0111], ln 6-13). Mahoney explains that this configuration, in which the driving wheel is contacted by two palls and the spacing between the pall ends is less than the length of a tooth of the driving wheel, has the result of limiting the amount by which the driving wheel can turn during a single push/pull induced movement of the driving portions to be less than one tooth’s length (see Fig. 14, [0107], ln 16-21, and [0111], ln 6-13). Such is not true if only one pall or other such contacting member is used, since such a single contacting member would need to turn the wheel at least one tooth’s length in order to find the surface of the next tooth upon which to push. Because the driving wheel of Mahoney turns a screw (202) which in turn moves a piston (204) dispensing the insulin (see Fig. 3-7 and 14, [0071-0084]), it follows that a system which can impart smaller movements of the driving wheel for a given actuator motion can also dispense the insulin in smaller amounts per actuator motion, thus the configuration of Mahoney imparts greater flow rate resolution and slower minimum infusion rate as compared to a configuration using only one driving portion to engage the driving wheel. Mahoney teaches that such a slower minimum infusion rate is desirable for insulin dispensation ([0094], ln 1-4).
Based on the teachings of Mahoney, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion module of Dilanni such that, rather than having a single driving portion to engage the driving wheel on each side of the driving unit, the infusion module may include two driving portions on each side of the driving unit engaging the driving wheel, as taught by Mahoney, and that the two driving portions on each side of the driving unit may be disposed up and down with respect to each other and the driving wheel, as also taught by Mahoney, in order to thereby impart a greater flow rate resolution and slower minimum infusion rate to the infusion module as compared to a configuration using only one driving portion to engage each driving wheel, Mahoney teaching that such a slower minimum infusion rate is desirable for insulin dispensation (see [0094], [0107], ln 16-21, and [0111], ln 6-13).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni as modified by Yang, Guerrini, Grosman, Bengtsson, and Haidar according to claim 1, and in further view of Scherb (WO2013023014A).
Regarding claim 8, Dilanni as modified by Yang, Guerrini, and Grosman according to claim 1 exhibits the bilaterally driven closed-loop artificial pancreas of claim 1, comprising a program module which is imported a total daily dose algorithm, as described above (see in re claim 1). None of these references teach that the variable factors of the total daily dose algorithm include one or more of user’s physical activity status, physiological status, psychological status, and meal status (Grosman teaching that total daily dose may be obtained by averaging of recorded measurements of insulin administered over a period of multiple days – see Grosman [0046-0052]), however, it is known in the art that program modules (controllers) of pumps such as that of Dilanni or Yang may estimate the total daily dose of insulin needed by a user based, at least in part, on the user’s physical activity, such as the amount of exercise expected or experienced within a future/past day, and physiology, such as weight, rather than based on direct measurements of previous insulin injections (see Scherb, [0008-0009]). Scherb, for example, exhibits a program module (controller) for an insulin pump similar to that of Dilanni and Yang (see Fig. 1 and [0005], ln 7-12), and teaches that the total daily dose of insulin (daily basal need of insulin) may be estimated according to physiological conditions, such as weight and height (thereby obtaining an at-rest estimate), and may be further adjusted based upon the user’s physical activity, such as a cumulative number of hours of activity reported by the user and/or exercise/exertion level as reported by the user or measured by heart rate measurement ([0008-0009] and [0011]). It is thus clear, based on these teachings, that when implementing the modification of Dilanni to include a total daily dose algorithm as discussed in re claim 1, one of ordinary skill in the art would have also found it obvious to configure the program module of Dilanni to estimate the total daily dose of insulin according to the method of Scherb instead of based upon recorded measurements of previous insulin injections, as taught by Grosman, such that the variable factors of the total daily dose algorithm include both user’s physical activity status (hours of activity, exercise/exertion level as reported by the user or measured by heart rate measurement) and physiological status (height and weight, for example), as a matter of simply selecting one among several suitable methods of estimating the total daily dose of insulin required by a user, both being known within the art to be suitable for the purpose and configuration of the bilaterally driven closed-loop artificial pancreas of Dilanni as modified by Yang, Guerrini, and Grosman according to claim 1. See MPEP 2143(I)(C).
Regarding claim 9, Scherb further teaches that the physical activity status includes exercise ([0011], and see in re claim 8)
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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