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
The amendment filed 03/13/26 has been entered. Claims 1, 11, and 18 have been amended. Claims 2-10, 12-17, and 19-20 are in the original/ previously presented form. Thus, claims 1-20 remain pending in the application. There were no objections or 112 rejections previously set forth in the Non-final office action mailed 12/18/25. Therefore, there are no objections or 112 rejections withstanding.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (U.S. PGPUB No. 20110145747), hereinafter Wong, in view of Mastrototaro et al. (U.S. PGPUB No. 2008/0269714), hereinafter Mastrototaro.
Regarding claim 1, Wong discloses a processor-implemented method (see FIG. 3 and [0067]) comprising:
obtaining status information pertaining to operation (see [0060-0064]: processor 102 obtains information from fluid delivery device 46 by communications module) of a fluid delivery device (46, see [0047]: individual 12 has diabetes and uses see [0050]: therapy device 42 can be ambulatory infusion pump 46 and [0049]: software 34 on computer/mobile device/ etc.)), the status information including fluid delivery data (see [0062]: data received from pump 46 and [0063]: data includes insulin dose values/ other information pertaining to fluid delivery device);
based on the status information (see FIG. 5B, [0088]: exit criteria 228 can be particular value==status information has been reached or other status information decisions, [0091-0092], and [0107-0109]), exiting a closed-loop operating mode (see FIG. 5B) of the fluid delivery device (see [0088]: exit by exit criteria), the closed-loop operating mode (see FIG. 5B) being an operating mode in which dosage commands are automatically generated based on sensor measurement data (see [0081-0083]: processor automated method by software 34 can include optimizing insulin therapy. Thus, new dosage commands/ a dosing schedule are automatically generated by the processor through the analysis of the sensor data); and
after exiting the closed-loop operating mode (see FIG. 5B), causing generation of a user notification recommending a remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as performing exercise, ingesting particular food, taking medicine and/or responding to questions/requests) to improve viability (see [0109]) of a subsequent instance (246 and see [0107]: “It is to be appreciated that in one embodiment the exit criteria 228 can establish the condition(s) needed to be met for entry criteria 226 of a second structured collection procedure 70”) of the closed- loop operating mode (see FIG. 5B).
Wong is silent to “and fluid is delivered in accordance with the dosage commands by the fluid delivery device.”
However, Mastrototaro teaches a processor-implemented method (see Fig. 14) comprising obtaining status information pertaining to operation of a fluid delivery device (see [0099-0100]), and based on the status information, exiting a closed-loop operating mode (see [0115-0116]: exiting closed loop based on sensor readings), the method further comprises automatically generating dosage commands (see [0115-0120]) based on sensor measurement data (see [0115]: delivery system controlled automatically based on sensor readings) and fluid is delivered in accordance with the dosage commands by the fluid delivery device (see [0115-0120]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method including obtaining status information related to a fluid delivery device and exiting a closed loop where dosage commands are automatically generated based on sensor measurement as disclosed in Wong to include delivering fluid in accordance with the dosage commands as taught by Mastrototaro for the purpose of preventing over delivery of insulin (see [0118]), which would be advantageous to Wong’s device that requires user analysis of the dosage commands before intervention occurs, thus achieving “and fluid is delivered in accordance with the dosage commands by the fluid delivery device.”
Regarding claim 2, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong further discloses wherein the remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as performing exercise, ingesting particular food, taking medicine and/or responding to questions/requests) improves the viability (see [0109]) of the subsequent instance (246 and see [0107]: “It is to be appreciated that in one embodiment the exit criteria 228 can establish the condition(s) needed to be met for entry criteria 226 of a second structured collection procedure 70”) of the closed-loop operating mode (see FIG. 5B) by reducing a likelihood that the subsequent instance of the closed-loop operating mode (see FIG. 5B) will automatically exit after reentry (see [0107-0109]: adherence criteria 224 must be met prior to moving to next instance and [0104-0105]: time delay may suspend next instance if user unable to perform action==reduces likelihood of exiting after reentry).
Regarding claim 3, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong further discloses wherein the user notification recommending the remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as perform a bG collection) includes one or more user notifications (see [0066]: audible/tactile/visual alarm for bG measurement) to manipulate a blood glucose meter to obtain one or more blood glucose measurement values (see [0048-0050]: collection device 24 may be blood glucose meter in combination with the ambulatory infusion pump 46, see [0062-0063]: collection device sends blood glucose values to processor).
Regarding claim 4, the modified method of Wong teaches the processor-implemented method of claim 1, but Wong is silent to “wherein the remedial action includes calibrating, replacing, or recharging a sensor arrangement.”
However, Mastrototaro teaches a processor-implemented method (see FIG. 13), requiring remedial action (S630), wherein the remedial action includes calibrating, replacing, or recharging a sensor arrangement (see [0098-0101]: sensor readings indicate a target level was not reached and thus a remedial action of a calibration should be performed by the user).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method including remedial action upon exiting of a closed loop operating mode disclosed in Wong to include a remedial action of calibrating a sensor arrangement as taught by Mastrototaro for the purpose of accounting for changes in sensor sensitivity during the sensor lifespan and/or to detect when a sensor has failed (see [0098]), thus achieving “wherein the remedial action includes calibrating, replacing, or recharging a sensor arrangement.”
Regarding claim 5, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong discloses further comprising determining the viability of the subsequent instance of the closed-loop operating mode (see [0107]: subsequent instance is not initiated until entry criterion 246 is satisfied. Therefore, the process performed at entry criterion 246 determines the viability of the subsequent instance) based on determining whether a control parameter of the closed-loop operating mode can be calculated based on the sensor measurement data (see [0107-0109]: contraindication can be provided to and/ or detected by processor such as blood glucose levels. Thus, contraindications may fail 246 and make the subsequent data collection non-viable. See [0084-0087] and [0103-0105] for further explanation of the adherence criterion process) .
Regarding claim 6, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong discloses further comprising determining the viability of the subsequent instance of the closed-loop operating mode (see [0107]: subsequent instance is not initiated until entry criterion 246 is satisfied. Therefore, the process performed at entry criterion 246 determines the viability of the subsequent instance) based on determining at least one of viability, reliability, or accuracy of the sensor measurement data (see [0107-0109]: contraindication can be provided to and/ or detected by processor such as blood glucose levels. Thus, contraindications may fail 246 and make the subsequent data collection non-viable. A contraindication is a determination of a viability/ reliability of the data. See also [0084-0087], specifically [0085]: unreliable data when patient says they fasted but they did not, and see [0103-0105] for further explanation of the adherence criterion process).
Regarding claim 7, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong further discloses wherein the status information (see [0085]: example of a received bG value is 340mg/dl compared to a fasting value of 120-180mg/dl) indicates that one or more parameters (an adherence criteria 224) of the closed-loop operating mode (see FIG. 5B) are invalid or unreliable (see [0085]: adherence criterion 242 can include responses to questions that deem the sensed data unreliable, i.e. patient says they fasted when they did not).
Regarding claim 8, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong further discloses wherein the status information indicates that the fluid delivery device has delivered insulin (see [0063]: glucose values for the individual are stored such as insulin dose values/types/ supplemental doses).
Wong is silent to the status information indicates that the fluid delivery device has delivered insulin “at a maximum insulin delivery limit, at a minimum insulin delivery limit, or in a suspension state for over a certain duration.”
However, Mastrototaro teaches a processor-implemented method (see Fig. 14) comprising obtaining status information pertaining to operation of a fluid delivery device (see [0099-0100]) and based on the status information, exiting a closed-loop operating mode (see [0115-0116]: exiting closed loop based on sensor readings), wherein the status information indicates that the fluid delivery device has delivered insulin at a maximum insulin delivery limit, at a minimum insulin delivery limit, or in a suspension state for over a certain duration (see [0104-0112]: delivery rate evaluated between max and minimum insulin limits and rate is constantly updated by control method such as s710 shown in FIG. 14).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method including obtaining status information and exiting a closed loop based on the status information as disclosed in Wong to include monitoring the specific status information of maximum and minimum insulin delivery limits as taught by Mastrototaro for the purpose of preventing over delivery of insulin (see [0118]), which would be dangerous to the individual, thus achieving the fluid delivery device has delivered insulin “at a maximum insulin delivery limit, at a minimum insulin delivery limit, or in a suspension state for over a certain duration.”
Regarding claim 9, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong further discloses wherein, in the closed-loop operating mode (see FIG. 5B), the dosage commands are automatically generated based on the sensor measurement data (see [0081-0083]: processor automated method by software 34 can include optimizing insulin therapy based on target values. Thus, new dosage commands/ a dosing schedule are automatically generated by the processor through the analysis of the sensor data) and a target physiological condition (see [0084-0087]: adherence criteria and entry condition evaluate sensed data relative to targets).
Regarding claim 10, the modified method of Wong teaches the processor-implemented method of claim 1, and Wong discloses further comprising: obtaining sensor measurement data from a sensor arrangement (biosensor 140, see FIG. 3 and [0062]: data from biosensor 140 can be from ambulatory infusion pump or see [0048-0050]: glucose meter in combination with pump), wherein exiting the closed-loop operating mode of the fluid delivery device includes exiting the closed-loop operating mode of the fluid delivery device based on the sensor measurement data (see [0088]: exit criteria 228 can be particular value==sensor measurement data has been reached or other status information decisions. Therefore, the closed loop mode is exited “based on” the data. See also [0091-0092], and [0107-0109]).
Regarding claim 11, Wong discloses a system comprising:
one or more processors (102, see FIG. 3); and
one or more processor-readable storage media (112) storing instructions which, when executed by the one or more processors, cause the one or more processors to perform operations (see [0057-0064] and [0067]) including:
obtaining status information pertaining to operation (see [0060-0064]: processor 102 obtains information from fluid delivery device 46 by communications module) of a fluid delivery device (46, see [0047]: individual 12 has diabetes and uses see [0050]: therapy device 42 can be ambulatory infusion pump 46 and [0049]: software 34 on computer/mobile device/ etc.)), the status information including fluid delivery data (see [0062]: data received from pump 46 and [0063]: data includes insulin dose values/ other information pertaining to fluid delivery device);
based on the status information (see FIG. 5B, [0088]: exit criteria 228 can be particular value==status information has been reached or other status information decisions, [0091-0092], and [0107-0109]), exiting a closed-loop operating mode (see FIG. 5B) of the fluid delivery device (see [0088]: exit by exit criteria), the closed-loop operating mode (see FIG. 5B) being an operating mode in which dosage commands are automatically generated based on sensor measurement data (see [0081-0083]: processor automated method by software 34 can include optimizing insulin therapy. Thus, new dosage commands/ a dosing schedule are automatically generated by the processor through the analysis of the sensor data); and
after exiting the closed-loop operating mode (see FIG. 5B), causing generation of a user notification recommending a remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as performing exercise, ingesting particular food, taking medicine and/or responding to questions/requests) to improve viability (see [0109]) of a subsequent instance (246 and see [0107]: “It is to be appreciated that in one embodiment the exit criteria 228 can establish the condition(s) needed to be met for entry criteria 226 of a second structured collection procedure 70”) of the closed- loop operating mode (see FIG. 5B).
Wong is silent to “and fluid is delivered in accordance with the dosage commands by the fluid delivery device.”
However, Mastrototaro teaches a system (see [0115]: system operates in the closed loop mode as shown in FIG. 14) comprising obtaining status information pertaining to operation of a fluid delivery device (see [0099-0100]), and based on the status information, exiting a closed-loop operating mode (see [0115-0116]: exiting closed loop based on sensor readings), the system further comprises automatically generating dosage commands (see [0115-0120]) based on sensor measurement data (see [0115]: delivery system controlled automatically based on sensor readings) and fluid is delivered in accordance with the dosage commands by the fluid delivery device (see [0115-0120]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system including obtaining status information related to a fluid delivery device and exiting a closed loop where dosage commands are automatically generated based on sensor measurement as disclosed in Wong to include delivering fluid in accordance with the dosage commands as taught by Mastrototaro for the purpose of preventing over delivery of insulin (see [0118]), which would be advantageous to Wong’s device that requires user analysis of the dosage commands before intervention occurs, thus achieving “and fluid is delivered in accordance with the dosage commands by the fluid delivery device.”
Regarding claim 12, the modified system of Wong teaches the system of claim 11, and Wong further discloses wherein the remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as performing exercise, ingesting particular food, taking medicine and/or responding to questions/requests) improves the viability (see [0109]) of the subsequent instance (246 and see [0107]: “It is to be appreciated that in one embodiment the exit criteria 228 can establish the condition(s) needed to be met for entry criteria 226 of a second structured collection procedure 70”) of the closed-loop operating mode (see FIG. 5B) by reducing a likelihood that the subsequent instance of the closed-loop operating mode (see FIG. 5B) will automatically exit after reentry (see [0107-0109]: adherence criteria 224 must be met prior to moving to next instance and [0104-0105]: time delay may suspend next instance if user unable to perform action==reduces likelihood of exiting after reentry).
Regarding claim 13, the modified system of Wong teaches the system of claim 11, but Wong is silent to “wherein the remedial action includes calibrating, replacing, or recharging a sensor arrangement.”
However, Mastrototaro teaches a system (see FIG. 3b and FIG. 13), requiring remedial action (S630), wherein the remedial action includes calibrating, replacing, or recharging a sensor arrangement (see [0098-0101]: sensor readings indicate a target level was not reached and thus a remedial action of a calibration should be performed by the user).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system including remedial action upon exiting of a closed loop operating mode disclosed in Wong to include a remedial action of calibrating a sensor arrangement as taught by Mastrototaro for the purpose of accounting for changes in sensor sensitivity during the sensor lifespan and/or to detect when a sensor has failed (see [0098]), thus achieving “wherein the remedial action includes calibrating, replacing, or recharging a sensor arrangement.”
Regarding claim 14, the modified system of Wong teaches the system of claim 11, and Wong further discloses wherein the user notification recommending the remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as perform a bG collection) includes one or more user notifications (see [0066]: audible/tactile/visual alarm for bG measurement) to manipulate a blood glucose meter to obtain one or more blood glucose measurement values (see [0048-0050]: collection device 24 may be blood glucose meter in combination with the ambulatory infusion pump 46, see [0062-0063]: collection device sends blood glucose values to processor).
Regarding claim 15, the modified system of Wong teaches the system of claim 11, and Wong further discloses wherein the operations further include determining the viability of the subsequent instance of the closed-loop operating mode (see [0107]: subsequent instance is not initiated until entry criterion 246 is satisfied. Therefore, the process performed at entry criterion 246 determines the viability of the subsequent instance) based on: whether a control parameter of the closed-loop operating mode can be calculated based on the sensor measurement data (see [0107-0109]: contraindication can be provided to and/ or detected by processor such as blood glucose levels. Thus, contraindications may fail 246 and make the subsequent data collection non-viable. See [0084-0087] and [0103-0105] for further explanation of the adherence criterion process); or at least one of viability, reliability, or accuracy of the sensor measurement data (see [0107-0109]: contraindication can be provided to and/ or detected by processor such as blood glucose levels. Thus, contraindications may fail 246 and make the subsequent data collection non-viable. A contraindication is a determination of a viability/ reliability of the data. See also [0084-0087], specifically [0085]: unreliable data when patient says they fasted but they did not, and see [0103-0105] for further explanation of the adherence criterion process).
Regarding claim 16, the modified system of Wong teaches the system of claim 11, and Wong further discloses wherein the status information (see [0085]: example of a received bG value is 340mg/dl compared to a fasting value of 120-180mg/dl) indicates that: one or more parameters (224) of the closed-loop operating mode (see FIG. 5B) are invalid or unreliable (see [0085]: adherence criterion 242 can include responses to questions that deem the sensed data unreliable, i.e. patient says they fasted when they did not); or the fluid delivery device has delivered insulin at a maximum insulin delivery limit, at a minimum insulin delivery limit, or in a suspension state for over a certain duration.
Regarding claim 17, the modified system of Wong teaches the system of claim 11, and Wong further discloses wherein the operations further include: obtaining sensor measurement data from a sensor arrangement (biosensor 140, see FIG. 3 and [0062]: data from biosensor 140 can be from ambulatory infusion pump or see [0048-0050]: glucose meter in combination with pump), wherein exiting the closed-loop operating mode of the fluid delivery device includes exiting the closed-loop operating mode of the fluid delivery device based on the sensor measurement data (see [0088]: exit criteria 228 can be particular value==sensor measurement data has been reached or other status information decisions. Therefore, the closed loop mode is exited “based on” the data. See also [0091-0092], and [0107-0109]).
Regarding claim 18, Wong discloses one or more non-transitory processor-readable storage media storing instructions (112, see FIG. 3 and [0057-0064] and [0067]) which, when executed by one or more processors (102), cause the one or more processors (102) to perform operations including:
obtaining status information pertaining to operation (see [0060-0064]: processor 102 obtains information from fluid delivery device 46 by communications module) of a fluid delivery device (46, see [0047]: individual 12 has diabetes and uses see [0050]: therapy device 42 can be ambulatory infusion pump 46 and [0049]: software 34 on computer/mobile device/ etc.)), the status information including fluid delivery data (see [0062]: data received from pump 46 and [0063]: data includes insulin dose values/ other information pertaining to fluid delivery device);
based on the status information (see FIG. 5B, [0088]: exit criteria 228 can be particular value==status information has been reached or other status information decisions, [0091-0092], and [0107-0109]), exiting a closed-loop operating mode (see FIG. 5B) of the fluid delivery device (see [0088]: exit by exit criteria), the closed-loop operating mode (see FIG. 5B) being an operating mode in which dosage commands are automatically generated based on sensor measurement data (see [0081-0083]: processor automated method by software 34 can include optimizing insulin therapy. Thus, new dosage commands/ a dosing schedule are automatically generated by the processor through the analysis of the sensor data); and
after exiting the closed-loop operating mode (see FIG. 5B), causing generation of a user notification recommending a remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as performing exercise, ingesting particular food, taking medicine and/or responding to questions/requests) to improve viability (see [0109]) of a subsequent instance (246 and see [0107]: “It is to be appreciated that in one embodiment the exit criteria 228 can establish the condition(s) needed to be met for entry criteria 226 of a second structured collection procedure 70”) of the closed- loop operating mode (see FIG. 5B).
Wong is silent to “and fluid is delivered in accordance with the dosage commands by the fluid delivery device.”
However, Mastrototaro teaches a processor-implemented method (see Fig. 14) having a processor to perform operations (see [0115]: algorithm and see controller 12 in FIG. 1 and described in [0052]) such as comprising obtaining status information pertaining to operation of a fluid delivery device (see [0099-0100]), and based on the status information, exiting a closed-loop operating mode (see [0115-0116]: exiting closed loop based on sensor readings), the method further comprises automatically generating dosage commands (see [0115-0120]) based on sensor measurement data (see [0115]: delivery system controlled automatically based on sensor readings) and fluid is delivered in accordance with the dosage commands by the fluid delivery device (see [0115-0120]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor performing operations including obtaining status information related to a fluid delivery device and exiting a closed loop where dosage commands are automatically generated based on sensor measurement as disclosed in Wong to include delivering fluid in accordance with the dosage commands as taught by Mastrototaro for the purpose of preventing over delivery of insulin (see [0118]), which would be advantageous to Wong’s device that requires user analysis of the dosage commands before intervention occurs, thus achieving “and fluid is delivered in accordance with the dosage commands by the fluid delivery device.”
Regarding claim 19, Wong discloses the one or more non-transitory processor-readable storage media of claim 18, and Wong further discloses wherein the user notification recommending the remedial action (see [0101]: exit criteria 228 include electronic reminders==user notification to perform action such as perform a bG collection) includes one or more user notifications (see [0066]: audible/tactile/visual alarm for bG measurement) to manipulate a blood glucose meter to obtain one or more blood glucose measurement values (see [0048-0050]: collection device 24 may be blood glucose meter in combination with the ambulatory infusion pump 46, see [0062-0063]: collection device sends blood glucose values to processor).
Regarding claim 20, Wong discloses the one or more non-transitory processor-readable storage media of claim 18, and Wong further discloses wherein the status information (see [0085]: example of a received bG value is 340mg/dl compared to a fasting value of 120-180mg/dl) indicates that: one or more parameters of the closed-loop operating mode are invalid or unreliable (see [0085]: adherence criterion 242 can include responses to questions that deem the sensed data unreliable, i.e. patient says they fasted when they did not); or the fluid delivery device has delivered insulin at a maximum insulin delivery limit, at a minimum insulin delivery limit, or in a suspension state for over a certain duration.
Response to Arguments
Applicant's arguments filed 03/13/26 have been fully considered but they are not persuasive.
On page 7 of Applicant remarks, Applicant submits that Wong fails to teach fluid being delivered in accordance with the dosage commands. This argument is moot in view of the new rejection under Wong in view of Mastrototaro that teaches the newly amended limitation.
Next on page 7, Applicant argues that Wong does not disclose causing generation of a user notification recommending a remedial action “after exiting the closed-loop operating mode”. However, the examiner disagrees with this characterization of the reference. FIG. 5B shows the closed loop of Wong (as cited in the claim rejections above). FIG. 5B is an iterative loop that has multiple events (237, see [0107]: “It is to be appreciated that in one embodiment the exit criteria 228 can establish the condition(s) needed to be met for entry criteria 226 of a second structured collection procedure 70”). Therefore, exiting of the loop in FIG.5B can occur via exit criteria 228 before generation of recommending remedial action that can be a part of entry/exit criteria or other guidance of the device (see [0101]). Therefore, the examiner maintains that Wong discloses generation of a user notification recommending a remedial action “after exiting the closed-loop operating mode”.
On page 8, Applicant argues that it would not have been obvious to combine the teachings of a behavior modification program (in Applicant’s example, Wong) with fluid delivery (in Applicant’s example, Mastrototaro). Applicant asserts that this is because Wong’s behavior modification program is so different from a fluid delivery program that delivers fluid with a fluid delivery device. The examiner disagrees. Although the disclosures of Wong and Mastrototaro may relate to different usages, both Wong and Mastrototaro monitor sensor data from a fluid delivery device in a closed-loop fashion. MPEP § 2143.01.II notes that, although prior art teachings may have conflicts (i.e.: the sensor data gathered in Wong’s closed loop method is generally used for behavior modification while the sensor data gathered in Mastrototaro’s closed loop method is generally used to automate fluid delivery by a fluid delivery device), the disclosures may still be combined when the references would not have “deterred one of ordinary skill in the art from using” the teachings. Thus, a person of ordinary skill in the art would have recognized that the sensor data that is already collected in Wong’s method could be utilized for another purpose beyond behavior modification (such as for controlling fluid delivery as taught in Mastrototaro). MPEP § 2123.I states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”. Therefore, the examiner was not persuaded by this argument and has maintained the combination of Wong in view of Mastrototaro to teach fluid delivery.
Because no further arguments were presented, the examiner has subsequently maintained the depending claim rejections.
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 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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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