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 .
This is the first office action in response to the above identified patent application filed on 04/17/2023. Claims 1-51 are currently pending and being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent Claim 1 recites the limitation "an assumed external dose" in lines 3-4. It is unclear if the recitation refer to an external dose of food or an external dose of insulin or an external dose of some other medication. Appropriate correction is required (an assumed external dose of insulin).
Dependent Claims 2-15 depend from Claim 1 and are rejected accordingly.
Independent Claim 16 recites the limitation "an assumed external dose" in lines 8-9. It is unclear if the recitation refer to an external dose of food or an external dose of insulin or an external dose of some other medication. Appropriate correction is required (an assumed external dose of insulin).
Dependent Claims 17-29 depend from Claim 16 and are rejected accordingly.
Independent Claim 30 recites the limitation "an assumed external dose" in line 9. It is unclear if the recitation refer to an external dose of food or an external dose of insulin or an external dose of some other medication. Appropriate correction is required (an assumed external dose of insulin).
Dependent Claims 31-43 depend from Claim 30 and are rejected accordingly.
Independent Claim 44 recites the limitation "an assumed external dose" in line 8. It is unclear if the recitation refer to an external dose of food or an external dose of insulin or an external dose of some other medication. Appropriate correction is required (an assumed external dose of insulin).
Dependent Claim 45 depend from Claim 44 and is rejected accordingly.
Independent Claim 46 recites the limitation "an assumed external dose" in line 13. It is unclear if the recitation refer to an external dose of food or an external dose of insulin or an external dose of some other medication. Appropriate correction is required (an assumed external dose of insulin).
Dependent Claims 47-51 depend from Claim 46 and are rejected accordingly.
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 1-16, 19, 27, 28, 30, 33-39, 41-48 and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/135,447 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the referencing copending application fully encompass the subject matter of the instant application claims and therefore anticipate the claims of the instant application. Since the claims of the instant application are anticipated by the claims of the referencing copending application, the claims of the instant application are not patentably distinct from the referencing copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/135,417 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the referencing copending application fully encompass the subject matter of the instant application claims and therefore anticipate the claims of the instant application. Since the claims of the instant application are anticipated by the claims of the referencing copending application, the claims of the instant application are not patentably distinct from the referencing copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 9, 15-18, 20-26, 29-32, 40, 42, 44, 46 and 48-50 are rejected under 35 U.S.C. 102a1 as being anticipated by Jepson et al. (US 2021/0205534).
In regards to Independent Claim 1, and with particular reference to Figures 1-3, Jepson discloses an insulin management method implemented by an insulin delivery system (medical device 108 to deliver insulin; par. 174), comprising:
determining an assumed insulin on board (prior art equation 1 in par. 186 is the same as the equation 6 in the instant application used to calculate the assumed IOB) based on an assumed external dose (pars. 340, 183 active insulin in the host’s body from a previous delivery session of the medical device 108 and/or from an external device 116) calculated (using equation 1) to correct an initial blood glucose value of the user to a target blood glucose (par. 186, 340 the active insulin amount is reduced from the bolus dose, see also equation 1 taking into account the measured glucose GC_M and the target glucose GC_T); and
delivering insulin from an insulin delivery device 108 with the insulin in the form of a plurality of correction bolus doses (par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187)
during a fasting period (when the meal component MC is zero due to not ingesting any food) in response to received blood glucose measurements (par. 172 glucose measurements by sensor 104; equation 1 also uses the glucose measures GC_M as an input),
the correction bolus doses compensated for by a determined insulin on board (pars. 185, 186, 347 the correction bolus does include an IOB component),
wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals the assumed insulin on board (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M).
Regarding dependent Claim 2, Jepson discloses wherein the insulin delivery device 108 is an automatic insulin delivery device (automatic via a controller, par. 194 mentions a controller used for carrying out the process of delivering insulin, see also figure 2 showing a processor, memory) attachable to a user's body (par. 174, the medical device 108 is wearable) for a duration of a fasting period (during a period when the hosts wearing the medical device but is not ingesting any food), and configured to refrain from administering basal insulin at a preset or default rate or in a preset or default pattern (no indication of a preset or default pattern in the disclosure).
Regarding dependent Claim 3, Jepson discloses further comprising: calculating each of the plurality of correction bolus doses by comparing an evaluated blood glucose measurement to the target blood glucose to obtain a difference, adjusting the difference by a user insulin sensitivity factor to obtain a resultant dose amount, and reducing the resultant dose amount by the determined insulin on board (par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187; (pars. 185, 186, 347 the correction bolus does include an IOB component, refer to equation 1).
Regarding dependent Claim 4, Jepson discloses further comprising, at the start of the delivery from the insulin delivery device, calculating the assumed external dose to correct an initial blood glucose measurement of the user to the target blood glucose (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M).
Regarding dependent Claim 5, Jepson discloses wherein the determined insulin on board is a combination of at least the assumed insulin on board and a known delivered insulin from the delivery device during the fasting period once insulin is delivered (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M).
Regarding dependent Claim 6, Jepson discloses wherein the correction bolus doses are calculated based on a user's insulin sensitivity factor obtained for the user (equation 1 includes a ISF factor).
Regarding dependent Claim 9, Jepson discloses wherein the evaluated blood glucose measurement is evaluated at least in part by smoothing the received blood glucose measurements with a low pass filter to reduce the effect of noise and/or abrupt perturbations to obtain blood glucose values (par. 171 data is filtered).
Regarding dependent Claim 15, Jepson discloses comprising limiting the correction bolus doses to a defined maximum dose per correction bolus dose such that the correction bolus dose is a divided portion of a total correction bolus dose (par. 375 teaches maximum dose).
In regards to Independent Claim 16, and with particular reference to Figures 1-3, Jepson discloses an insulin management method implemented by a controller (par. 194 mentions a controller used for carrying out the process of delivering insulin, see also figure 2 showing a processor, memory) of an insulin delivery device (medical device 108 to deliver insulin; par. 174) for delivering insulin during a fasting period (during a period when the hosts wearing the medical device but is not ingesting any food) from a delivery device 108 in the form of a wearable automated insulin delivery device (par. 174, the medical device 108 is wearable), comprising:
determining a user insulin sensitivity factor (par. 186, the ISF factor is taken into account in equation 1 implying it is determined);
receiving blood glucose measurements; evaluating the blood glucose measurements to obtain evaluated blood glucose values (par. 172 glucose measurements by sensor 104; equation 1 also uses the glucose measures GC_M as an input; pars. 205, 311 reading high glucose levels);
determining an assumed insulin on board (prior art equation 1 in par. 186 is the same as the equation 6 in the instant application used to calculate the assumed IOB) based on an assumed external dose (pars. 340, 183 active insulin in the host’s body from a previous delivery session of the medical device 108 and/or from an external device 116) calculated (using equation 1) to correct an initial blood glucose value of the user to a target blood glucose (par. 186, 340 the active insulin amount is reduced from the bolus dose, see also equation 1 taking into account the measured glucose GC_M and the target glucose GC_T);
calculating periodic correction bolus doses by comparing an evaluated blood glucose value to a target blood glucose to obtain a difference, the difference adjusted by the user insulin sensitivity factor to obtain a resultant dose amount, and the resultant dose amount compensated by a determined insulin on board (refer to equation 1, also pars. 185, 186, 347 the correction bolus doses do include an ISF component and take into account the active insulin IOA), wherein:
correction bolus doses in an initial period are calculated using the determined insulin on board set equal to the assumed insulin on board (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M); and
delivering at least a portion of a calculated correction dose at periodic time intervals (par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187; par. 172, 328 the glucose measurement occurs periodically and so will the delivery of insulin).
Regarding dependent Claim 17, Jepson discloses wherein the assumed insulin on board (equation 1) is initially assumed to be sufficient to bring an initial blood glucose measurement GC_M into a target range GC_T and is reduced over time during the fasting period (reduced if the measured is close to the target value).
Regarding dependent Claim 18, Jepson discloses including adjusting the assumed insulin on board over time based on comparisons between to the evaluated blood glucose measurement (the assumed IOB in equation 1 changes with changes in GC_measured).
Regarding dependent Claim 20, Jepson discloses including dividing the correction dose into delivery portions with a maximum delivery rate for a maximum amount of insulin to be delivered over a given time period (pars. 328, 375 maximum allowable value).
Regarding dependent Claim 21, Jepson discloses including determining an initial user insulin sensitivity factor for the fasting period based on a received total daily basal dose information (initial ISF factor in equation 1; par. 233).
Regarding dependent Claim 22, Jepson discloses including adjusting the initial user insulin sensitivity factor by a sensitivity safety factor configured to bias the calculating periodic correction bolus doses to less insulin dosage (par. 262 determines plural ISFs implying these are adjusted).
Regarding dependent Claim 23, Jepson discloses including adjusting the target blood glucose by a target safety factor (par. 311 safety factor) based at least in part on a difference between a received blood glucose measurement and the target blood glucose (par. 186, shown in equation 1).
Regarding dependent Claim 24, Jepson discloses including adjusting the calculated correction bolus dose by an overall safety factor (par. 311 safety factor) configured to limit the calculated bolus dose to a maximum delivery rate for insulin to be delivered over a time period between delivery of correction bolus doses (par. 375 maximum allowable value).
Regarding dependent Claim 25, Jepson discloses wherein the target blood glucose is time varying to decrease over time during the fasting period and a rate of decrease over time of the target blood glucose is determined based on an assumption that blood glucose levels are being lowered by existing externally administered insulin administered prior to the fasting period (par. 186, target glucose is dependent on age and other factor which implies it varies with time).
Regarding dependent Claim 26, Jepson discloses wherein the user insulin sensitivity factor is initially (initial ISF factor in equation 1; par. 233) set at a predetermined value and adjusted over time based at least in part on a difference between received blood glucose measurements and expected blood glucose (par. 262 determines plural ISFs implying these are adjusted).
Regarding dependent Claim 29, Jepson discloses wherein delivering at least a portion of the correction doses includes delivering a first zero dose (meal component MC = 0 when no meal, that’s is, C =0, MC is in units of insulin, refer to equation 2 in par. 187).
In regards to Independent Claim 30, and with particular reference to Figures 1-3, Jepson discloses an insulin management system of an insulin delivery device (medical device 108 to deliver insulin; par. 174) in the form of an automatic (automatic via a controller, par. 194 mentions a controller used for carrying out the process of delivering insulin, see also figure 2 showing a processor, memory) insulin delivery device attachable to a user's body (par. 174, the medical device 108 is wearable) for a duration of a fasting period (during a period when the hosts wearing the medical device but is not ingesting any food), the system comprising:
a delivery component of the insulin delivery device 108 configured to deliver insulin in the form of a plurality of correction bolus doses in response to received blood glucose measurements (par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187),
the correction bolus doses compensated for by a determined insulin on board (pars. 185, 186, 347 the correction bolus does include an IOB component),
wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals the assumed insulin on board (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M).
based on an assumed external dose (pars. 340, 183 active insulin in the host’s body from a previous delivery session of the medical device 108 and/or from an external device 116) calculated (using equation 1) to correct an initial blood glucose value of the user to a target blood glucose (par. 186, 340 the active insulin amount is reduced from the bolus dose, see also equation 1 taking into account the measured glucose GC_M and the target glucose GC_T).
Regarding dependent Claim 31, Jepson discloses wherein the delivery component includes: an insulin sensitivity factor (ISF shown in equation 1 in par. 186) receiving component configured to determine a user insulin sensitivity factor; a blood glucose measurement receiving component (GC_M in equation 1 in par. 186) configured to periodically receive blood glucose measurements; a blood glucose measurement evaluating component (par. 169 glucose sensors in unit 104) configured to evaluate the blood glucose measurements; a correction dose calculating component configured to calculate the periodic correction bolus (par. 186); and the delivery component delivering at least a portion of a calculated correction dose at time intervals (via the delivering medical device 108).
Regarding dependent Claim 32, Jepson discloses wherein the insulin sensitivity factor receiving component is configured to derive an initial insulin sensitivity factor from a total daily basal dose information received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses (refer to ISF in equation 1 par. 186).
Regarding dependent Claim 40, Jepson discloses wherein the delivery component includes a safety factor component configured to provide safety factors to parameters on which the dose correction is based (par. 311 safety factor).
Regarding dependent Claim 42, Jepson discloses wherein the delivery component includes a processor and a memory configured to provide non-transitory, computer-readable program instructions to the processor to execute functions of the components (par. 194 mentions a controller used for carrying out the process of delivering insulin, see also figure 2 showing a processor, memory).
In regards to Independent Claim 44, and with particular reference to Figures 1-3, Jepson discloses an automatic (automatic via a controller, par. 194 mentions a controller used for carrying out the process of delivering insulin, see also figure 2 showing a processor, memory) insulin delivery device (medical device 108 to deliver insulin; par. 174) attachable to a user's body (par. 174, the medical device 108 is wearable) for a duration of a fasting period (during a period when the hosts wearing the medical device but is not ingesting any food), the device comprising:
a durable portion (any portion that is not disposable or a onetime use; controller) including a delivery component of the insulin delivery device 108 configured to deliver insulin in the form of a plurality of correction bolus doses in response to received blood glucose measurements (par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187),
the correction bolus doses compensated for by a determined insulin on board (pars. 185, 186, 347 the correction bolus does include an IOB component),
wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals the assumed insulin on board (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M).
based on an assumed external dose (pars. 340, 183 active insulin in the host’s body from a previous delivery session of the medical device 108 and/or from an external device 116) calculated (using equation 1) to correct an initial blood glucose value of the user to a target blood glucose (par. 186, 340 the active insulin amount is reduced from the bolus dose, see also equation 1 taking into account the measured glucose GC_M and the target glucose GC_T).
and
a disposable portion including a reservoir configured to contain insulin (insulin reservoir not schematically shown but implied since the device delivers insulin to the host and prior to delivering to the host, the insulin has to be stored in a container of the device, once the container is emptied it can be disposed) and configured to automatically deliver the correction bolus doses to the user (par. 194, figure 2 automatically carrying out the process via the controller/processor/memory; par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187).
In regards to Independent Claim 46, and with particular reference to Figures 1-3, Jepson discloses a computer-implemented method for managing delivery of insulin during a fasting period (during a period when the hosts wearing the medical device but is not ingesting any food) from a delivery device (medical device 108 to deliver insulin; par. 174) in the form of a wearable automated insulin delivery device worn for the fasting period (par. 174, the medical device 108 is wearable), wherein the method is carried out by a computing application provided at a mobile user computing device (112 as shown in figure 1), the method comprising:
requesting a value from a user of a total daily basal dose information used in a defined period prior to the fasting period (as shown in figure 7, requesting value from a user via questions);
pairing the mobile user computing device 112 to a controller (par. 194 mentions a controller used for carrying out the process of delivering insulin, see also figure 2 showing a processor, memory) of the delivery device, the controller configured to deliver insulin in the form of a plurality of correction bolus doses in response to received blood glucose measurements (par. 183 bolus doses of insulin; the bolus doses are corrected by the corrected component CC and the meal component MC, par. 186, 187),
the correction bolus doses compensated for by a determined insulin on board (pars. 185, 186, 347 the correction bolus does include an IOB component),
wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals the assumed insulin on board (pars. 80, 186 during a first time period using equation 1 the assumed IOB can be set as the determined IOB for the process is just starting, after the first period of time the determined IOB will change based on new readings of glucose measurements GC_M).
based on an assumed external dose (pars. 340, 183 active insulin in the host’s body from a previous delivery session of the medical device 108 and/or from an external device 116) calculated (using equation 1) to correct an initial blood glucose value of the user to a target blood glucose (par. 186, 340 the active insulin amount is reduced from the bolus dose, see also equation 1 taking into account the measured glucose GC_M and the target glucose GC_T); and
transmitting and receiving information to and from the controller of the delivery device during the fasting period (transmitting information between the medical device 108, mobile 112, sensors 104 as shown in at least figures 1, 2, 7).
Regarding dependent Claim 48, Jepson discloses wherein the method includes pairing the mobile user computing device 112 to a blood glucose monitor 104 to transfer blood glucose measurements to the delivery device, refer to figure 1.
Regarding dependent Claim 49, Jepson discloses wherein the method provides a display of a session history of information relating to the fasting period (displaying information in par. 8, 16, 24, 42).
Regarding dependent Claim 50, Jepson discloses wherein the method includes providing user training in use of a delivery device (implied that any user needs training on a new device).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741
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