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 .
Acknowledgments
In the reply, filed on July 20, 2026, Applicant amended claims 1-2, 4-5, 7-8, 11, 13-20, and 22.
Applicant added new claims 23-27.
In the non-final rejection of April 20, 2026, Examiner noted that the information disclosure statement filed January 4, 2024 (20 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant did not address the concerns in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed January 4, 2024 (39 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant did not address the concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed January 4, 2024 (31 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant did not address the concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed January 4, 2024 (18 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant submitted an information disclosure statement on July 28, 2026, correcting the indicated citation. Concern is withdrawn.
Examiner noted that the information disclosure statement filed January 4, 2024 (28 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant did not address the concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statements filed January 4, 2024, fail to comply with 37 CFR 1.98(a)(2). Applicant submitted copies of some of the indicated foreign patent documents and non-patent literature documents; however, Applicant did not provide copies of at least WO 2017205816, WO 0013580, EP 0867196, WO 9962576, EP 1177802, WO 9910049, International Search Report and Written Opinion of PCT/US2022/055745, WO 0030705, Web-Site Brochure dated 12/20/99, and WO 2018009614. Concern is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract; however, Applicant did not address all of the objections. Objection is maintained.
Examiner objected to claims 1-2, 4-5, 7-8, 11, 13-20, and 22. Applicant amended claims 1-2, 4-5, 7-8, 11, 13-20, and 22; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 2-5, 14, and 22 under 35 U.S.C. 112(b). Applicant amended claims 2, 14, and 22; however, Applicant did not address all of the rejections. Rejection is maintained.
Information Disclosure Statement
The information disclosure statement filed January 4, 2024 (20 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 20120203085 has been provided with the incorrect name of patentee of Tsukamoto. The correct name of patentee for US 20120203085 is Rebec. Thus, it is unclear whether Applicant is intending to cite US 20120203085 or another document to Tsukamoto
The citation for US 20110218495 has been provided with the incorrect name of patentee of Remebe. The correct name of patentee for US 20110218495 is Remde. Thus, it is unclear whether Applicant is intending to cite US 20110218495 or another document to Remebe
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed January 4, 2024 (39 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 6740059 has been provided with the incorrect name of patentee of Greene. The correct name of patentee for US 6740059 is Flaherty. Thus, it is unclear whether Applicant is intending to cite US 6740059 or another document to Greene
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed January 4, 2024 (31 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
US 5954699 is a withdrawn patent; thus, Examiner does not have access to the indicated document. Applicant is requested to file a copy of the indicated document
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed January 4, 2024 (28 pages) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
US 5954699 is a withdrawn patent; thus, Examiner does not have access to the indicated document. Applicant is requested to file a copy of the indicated document
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statements filed January 4, 2024, fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
Copies of foreign patent documents with lined-through citations have not been provided
Copies of non-patent literature documents with lined-through citations have not been provided
The information disclosure statement filed July 28, 2026, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
US 5954699 is a withdrawn patent; thus, Examiner does not have access to the indicated document. Applicant is requested to file a copy of the indicated document
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The abstract of the disclosure is objected to because:
In line 6, “meal detection” should be changed to “the meal detection”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 5, 8, 13, and 23-26 are objected to because of the following informalities:
In regards to claim 5, line 4, “the insulin bolus” should be changed to “an insulin bolus”.
In regards to claim 5, line 7, “an insulin bolus” should be changed to “the insulin bolus”.
In regards to claim 8, line 2, “the comprising:” should be changed to “the method comprising:”.
In regards to claim 8, line 12, “in” should be changed to “within”.
In regards to claim 13, lines 1-2, “the glucose level” should be changed to “the glucose level trend of the user”.
In regards to claim 23, line 8, “the insulin bolus request” should be changed to “the insulin bolus of the request”.
In regards to claim 24, line 2, “glucose level values” should be changed to “the glucose level values”.
In regards to claim 24, line 4, “the glucose level” should be changed to “a glucose level”.
In regards to claim 24, line 5, “the maximum” should be changed to “a maximum”.
In regards to claim 24, line 6, “the insulin bolus dose” should be changed to “the insulin bolus”.
In regards to claim 25, line 4, “delivery” should be changed to “the delivery”.
In regards to claim 25, lines 4-5, “glucose levels” should be changed to “the glucose levels”.
In regards to claim 26, line 5, “insulin boluses” should be changed to “the insulin boluses”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
21. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
22. Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 27, lines 1-5 recite: “wherein the determining of the glucose level trend and the adjusting of the specified bolus dose are performed exclusively by the processor of the insulin delivery device without transmitting the insulin bolus request to a remote bolus calculator for the determination of the glucose level trend or the adjustment of the specified bolus dose”; however, such is new matter not described in the Specification.
23. 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.
Claim 5 is 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.
In regards to claim 5, line 2 recites “the checking”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-12 and 15-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al (US 2018/0075200).
In regards to claim 1, Davis et al teaches a method performed by a processor (8) of an insulin delivery device (100), the method comprising:
monitoring glucose level values for a user with the processor of the insulin delivery device (paragraph [0086]: glucose sensor can use any known method, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescent monitoring), to provide a data stream indicative of the concentration of glucose in a host)
receiving an insulin bolus request for delivery of a specified bolus dose of insulin via the insulin delivery device to the user (Figure 1A)(paragraph [0099]: insulin pump to receive and track glucose values transmitted from analyte sensor system 8. One reason is to provide the insulin pump a capability to suspend or activate insulin administration when a glucose value falls below a threshold value)
with the processor of the insulin delivery device, determining a glucose level trend of the user based on the monitoring (paragraph [0014]: glucose trends)
with the processor of the insulin delivery device, adjusting the specified bolus dose of insulin in the insulin bolus request based on the determined glucose level trend of the user showing a glucose level characteristic (paragraph [0187]: bolus calculation should be adjusted for a determined glucose trend)
delivering an insulin bolus of the adjusted specified bolus dose to the user via the insulin delivery device (paragraph [0246]: deliver a bolus of insulin)
In regards to claim 2, Davis et al teaches wherein:
the glucose level characteristic is a substantial rise in glucose level of the user (Figure 11)
the adjusting of the specified bolus dose is performed only where the substantial rise in glucose level of the user exists (Figure 11)
In regards to claim 3, Davis et al teaches wherein the adjusting comprises determining a corrected insulin bolus dose to compensate for ingestion of a meal by the user (Figure 11).
In regards to claim 4, Davis et al teaches wherein a larger of the corrected insulin bolus dose and the specified bolus dose is set as the adjusted specified bolus dose and delivered to the user via the insulin delivery device (Figure 11)(paragraph [0246]).
In regards to claim 5, Davis et al teaches wherein
where the checking determines that there is no substantial rise in glucose level of the user (paragraph [0240]: trend is flat)
delivering the insulin bolus of the specified bolus dose to the user via the insulin delivery device (paragraph [0246]: deliver a bolus of insulin)
not performing the adjusting of the specified bolus dose (paragraph [0240]: no adjustment will generally be made)
not delivering an insulin bolus of the adjusted specified bolus dose to the user via the insulin delivery device (paragraph [0240]: no adjustment will generally be made)
In regards to claim 6, Davis et al teaches displaying on a display a notification that the adjusted specified bolus dose of insulin was delivered to the user via the insulin delivery device (Figure 11)(paragraph [0246]).
In regards to claim 7, Davis et al teaches displaying on the display a confirmation request for confirming the delivery of the adjusted specified dose (Figure 11).
In regards to claim 8, Davis et al teaches a method performed by a processor (8) of an insulin delivery device (100), the comprising:
receiving a request for delivery of an insulin bolus of a specified bolus dose to a user by the insulin delivery device (Figure 1A)(paragraph [0099]: insulin pump to receive and track glucose values transmitted from analyte sensor system 8. One reason is to provide the insulin pump a capability to suspend or activate insulin administration when a glucose value falls below a threshold value)
determining with the processor of the insulin delivery device whether the user likely has eaten within an interval (Figure 11)(paragraph [0014]: glucose trends) and/or whether the user has already received a bolus of insulin within a time window (paragraph [0246]: has already bolused)
where it is determined that the user likely has eaten within the interval and/or the user has already received the bolus of insulin within the time window, adjusting the specified bolus dose of the requested insulin bolus with the processor of the insulin delivery device to account for the user likely having eaten and/or the user having already received the bolus of insulin in the time window (paragraph [0187]: bolus calculation should be adjusted for a determined glucose trend)(paragraph [0099]: suspend… insulin administration when a glucose value falls below a threshold value)
with the processor of the insulin delivery device, causing delivery of the insulin bolus of the adjusted specified bolus dose to the user by the insulin delivery device (paragraph [0246]: deliver a bolus of insulin)
In regards to claim 9, Davis et al teaches wherein the request is from an external electronic device (110/120/130/140) (Figure 1A).
In regards to claim 10, Davis et al teaches wherein the external electronic device is a management device (110/120/130/140) for the insulin delivery device (Figure 1A).
In regards to claim 11, Davis et al teaches wherein the determining whether the user likely has eaten within the interval comprises analyzing a glucose level trend of the user (paragraph [0014]: glucose trends).
In regards to claim 12, Davis et al teaches wherein the analyzing the glucose level trend of the user comprises analyzing the glucose level trend to identify a rise in glucose level associated with ingesting a meal (Figure 11).
In regards to claim 15, Davis et al teaches wherein it is determined that the user likely has eaten within the interval and wherein the adjusting the specified bolus dose of the requested insulin bolus comprises increasing the specified bolus dose of the requested insulin bolus (Figure 11).
In regards to claim 16, Davis et al teaches wherein it is determined that the user likely has not eaten within the interval and the adjusting the specified bolus dose of the requested insulin bolus comprises decreasing the specified bolus dose of the requested insulin bolus (paragraph [0099]: suspend… insulin administration when a glucose value falls below a threshold value).
In regards to claim 17, Davis et al teaches wherein it is determined that the user has already received the bolus of insulin within the time window and the adjusting the specified bolus dose of the requested insulin bolus comprises decreasing the specified bolus dose of the requested insulin bolus (paragraph [0099]: suspend… insulin administration when a glucose value falls below a threshold value).
In regards to claim 18, Davis et al teaches wherein it is determined that the user likely has not eaten within the interval and the adjusting the specified bolus dose of the requested insulin bolus with the processor of the insulin delivery device comprises adjusting the specified bolus dose of the requested insulin bolus to zero (paragraph [0099]: suspend… insulin administration when a glucose value falls below a threshold value).
In regards to claim 19, Davis et al teaches wherein it is determined that the user has already received the bolus of insulin within the time window and the adjusting the specified bolus dose of the requested insulin bolus with the processor of the insulin delivery device comprises adjusting the specified bolus dose of the requested insulin bolus to zero (paragraph [0099]: suspend… insulin administration when a glucose value falls below a threshold value).
In regards to claim 20, Davis et al teaches an insulin delivery system (Figure 1A) for delivering insulin to a user, the insulin delivery system comprising:
an insulin delivery device (100) comprising:
a reservoir (136) storing the insulin (paragraph [0099]: insulin pump)
a non-transitory computer-readable storage medium for storing computer programming instructions for a single entity that is in control of determining doses and causing delivery of the insulin to the user from the insulin delivery device to the user (paragraph [0264]: Implementations of the subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a tangible and non-transitory computer readable medium for execution by, or to control the operation of, data processing apparatus)(paragraph [0099]: medical device 136 may be an insulin pump for administering insulin to a user, as shown in FIG. 1B. For a variety of reasons, it may be desirable for such an insulin pump to receive and track glucose values transmitted from analyte sensor system 8. One reason is to provide the insulin pump a capability to suspend or activate insulin administration when a glucose value falls below a threshold value), the single entity including:
a bolus calculator for calculating the doses for insulin boluses to be delivered to the user (Figure 11)
a controller for controlling automated insulin delivery to the user (paragraph [0019]: bolus calculator settings/parameters may include a basal rate)
a processor (8) for executing the computer programming instructions of the single entity to determine the doses and cause the delivery of the insulin to the user from the insulin delivery device (paragraph [0187]: bolus calculation)(paragraph [0246]: deliver a bolus of insulin)
a user interface (110/120/130/140) in communication with the bolus calculator
In regards to claim 21, Davis et al teaches wherein the user interface is on a remote device (110/120/130/140) that is remote from the insulin delivery device (Figure 1A).
In regards to claim 22, Davis et al teaches wherein the remote device is a smartphone (120) or a smartwatch (140).
In regards to claim 23, Davis et al teaches wherein the determining whether the user has already received the bolus of insulin within the time window comprises comparing the request for delivery of the insulin bolus against a prior bolus delivery record stored by the insulin delivery device, the comparing including at least one of: comparing a time of the request for delivery of the insulin bolus to a time of a prior bolus delivery; comparing a carbohydrate amount associated with the request for delivery of the insulin bolus to a carbohydrate amount associated with the prior bolus delivery; or comparing a dose amount of the insulin bolus request to a dose amount of the prior bolus delivery (paragraphs [0247][0248]).
In regards to claim 24, Davis et al teaches with the processor of the insulin delivery device, determining that there is not a rise in glucose level values for the user greater than a threshold amount over a time period based on the monitoring (paragraph [0240]: trend is flat); calculating a corrected insulin bolus dose that is needed to bring the glucose level of the user to a target glucose level; and choosing the maximum of the specified bolus dose or the corrected insulin bolus dose as the insulin bolus dose to be delivered (Figure 11)(paragraph [0246]).
In regards to claim 25, Davis et al teaches the method further comprising: delivering a partial insulin bolus dose via the insulin delivery device, the partial insulin bolus dose being less than the specified bolus dose; monitoring a trend of glucose levels of the user after delivery of the partial insulin bolus dose; and based on the monitored trend of glucose levels of the user, determining whether to terminate delivery of a remainder of the specified bolus dose )paragraph [0099]).
In regards to claim 26, Davis et al teaches wherein the user interface is provided on a management device that is separate from the insulin delivery device (Figure 1A), the user interface being configured to enable input for the bolus calculator (Figures 1A, 11), wherein the user interface is in communication with the bolus calculator and the management device is restricted from initiating delivery of insulin boluses to the user without the single entity first assessing the input from the user interface (paragraph [0145]).
In regards to claim 27, Davis et al teaches wherein the determining of the glucose level trend and the adjusting of the specified bolus dose are performed exclusively by the processor of the insulin delivery device without transmitting the insulin bolus request to a remote bolus calculator for the determination of the glucose level trend or the adjustment of the specified bolus dose (Figure 1A).
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.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al, as applied to claim 11 above, and further in view of Helgeson (US 2022/0105282).
In regards to claim 13, Davis et al is silent about wherein the analyzing the glucose level is performed by one machine learning model. Helgeson teaches a method, wherein analyzing a glucose level is performed by one machine learning model (paragraphs [0100][0101]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify analyzing the glucose level, of the method of Davis et al, to be performed by one machine learning model, as taught by Helgeson, as such will determine additional injection sites to recommend to a user (paragraph [0100]) which may encourage site rotation and may reduce the effects of lipohypertrophy caused by multiple daily injections. and as a result, may improve insulin delivery (paragraph [0035]).
In regards to claim 14, Davis et al is silent about wherein the analyzing the glucose level rend of the user is performed by multiple machine learning models. Helgeson teaches a method, wherein analyzing a glucose level trend of a user is performed by multiple machine learning models (paragraphs [0100][0101]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzing the glucose level of the user, of the method of Davis et al, to be performed by multiple machine learning models, as taught by Helgeson, as such will determine additional injection sites to recommend to a user (paragraph [0100]) which may encourage site rotation and may reduce the effects of lipohypertrophy caused by multiple daily injections. and as a result, may improve insulin delivery (paragraph [0035]).
Response to Arguments
Applicant's arguments filed July 20, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: First, paragraph [0187] describes a healthcare provider (HCP) configuration workflow in which the HCP selects, in advance, whether a trend adjustment parameter will be applied to the bolus calculator. This paragraph describes a setup or provisioning step performed by an HCP using a remote configuration interface. It does not describe the insulin delivery device itself determining a glucose level trend at the time of a bolus request. The step described in paragraph [0187] is an HCP parameter-setting action, not a real-time on-device trend determination. Second, Davis at paragraph [0099] expressly describes the medical device - the insulin pump - as a "passive device" that receives and tracks glucose values transmitted from an analyte sensor system: "Medical device 136 may be a passive device in example embodiments of the disclosure. For example medical device 136 may be an insulin pump for administering insulin to a user, as shown in FIG. 1B." A passive device that receives transmitted glucose values does not perform the step of determining a glucose level trend; it receives data that has already been processed elsewhere. The trend determination in Davis occurs in the bolus calculator application, which Davis describes as residing on a separate display device (e.g., a smartphone or CGM-connected app), not on the insulin pump itself (Remarks, page 10). Examiner disagrees. Davis et al teaches with the processor of the insulin delivery device (100), determining a glucose level trend of the user based on the monitoring (paragraph [0014]: bolus calculator that is informed by various CGM aspects, including glucose trends). The bolus calculator resides on display device 120 (Figure 11), which is a component of the insulin delivery device (100) (Figure 1A).
In regards to claim 1, Applicant argued: Applicant respectfully submits that the Examiner's mapping again confounds two architecturally distinct components of Davis: the bolus calculator (a remote app on the patient's phone or CGM device) and the insulin delivery device (the pump). As established above, Davis treats the pump as a passive downstream executor. The trend- based dose adjustment in Davis is performed by the bolus calculator app on a separate device; the adjusted bolus recommendation is then communicated to the delivery device for execution. Davis does not disclose the processor of the insulin delivery device performing the adjustment step. The Examiner has improperly attributed the computational functions of Davis's remote bolus calculator to the insulin delivery device (Remarks, page 11). Examiner disagrees. Davis et al teaches with the processor of the insulin delivery device (100), adjusting the specified bolus dose of insulin in the insulin bolus request based on the determined glucose level trend of the user showing a glucose level characteristic (paragraph [0187]: bolus calculation should be adjusted for a determined glucose trend). The bolus calculator resides on display device 120 (Figure 11), which is a component of the insulin delivery device (100) (Figure 1A).
In regards to claim 8, Applicant argued: Applicant respectfully submits that the Examiner's mapping conflates two fundamentally distinct concepts: insulin-on-board (IOB) calculation and a determination of whether the user has already received a bolus within a time window. First, IOB is a pharmacokinetic parameter that estimates the residual physiological activity of previously administered insulin based on a decay model. It is a scalar value used as an input to a bolus dose formula: specifically, as a subtracted term in the calculation of a recommended dose. IOB does not constitute a determination of whether a bolus was recently delivered within a defined time window, nor does it involve any comparison of a current bolus request against a stored record of prior deliveries. Second, paragraph [0014] expressly locates the IOB computation in "the CGM app," not in the processor of the insulin delivery device. Davis at paragraph [0014] states that "[t]he CGM app may further be enabled to compute IOB for MDI users within the context of the bolus calculator." The IOB function Davis describes is performed by a software component on the patient's phone or CGM device, not by the insulin delivery device's processor. Third, Davis at paragraph [0099] describes the insulin delivery device as a passive receiver of glucose data. A passive receiver does not perform a determination of whether a bolus has already been delivered within a time window based on stored delivery history. Davis discloses no delivery-history comparison function on the insulin delivery device (Remarks, page 12). Examiner disagrees. Davis et al teaches determining with the processor of the insulin delivery device (100) whether the user likely has eaten within an interval (Figure 11)(paragraph [0014]: bolus calculator that is informed by various CGM aspects, including glucose trends) and/or whether the user has already received a bolus of insulin within a time window (paragraph [0246]: upon the calculation of a bolus value, a message may be sent to one or more followers, e.g., via text message, app, or the like. Such may indicate to the follower that the patient… has already bolused where such data is available). The bolus calculator resides on display device 120 (Figure 11), which is a component of the insulin delivery device (100) (Figure 1A).
In regards to claim 8, Applicant argued: Applicant respectfully submits that user-entered meal size data is not equivalent to the claimed determination of whether the user likely has eaten within an interval. The claim requires that the processor determine whether the user has likely eaten, which is an automated inference step. A system that receives manual carbohydrate entry from the user has not determined whether the user has eaten; it has received a user assertion to that effect. Davis discloses no automated detection or inference of meal ingestion by the processor of the insulin delivery device (Remarks, page 13). Examiner disagrees. Davis et al teaches determining with the processor of the insulin delivery device (100) whether the user likely has eaten within an interval (Figure 11)(paragraph [0014]: bolus calculator that is informed by various CGM aspects, including glucose trends) and/or whether the user has already received a bolus of insulin within a time window (paragraph [0246]: upon the calculation of a bolus value, a message may be sent to one or more followers, e.g., via text message, app, or the like. Such may indicate to the follower that the patient… has already bolused where such data is available).
In regards to claim 20, Applicant argued: First, paragraph [0264] is a generic boilerplate implementation paragraph describing, at the highest level of abstraction, that the subject matter of the patent can be implemented in software, hardware, or combinations thereof. It does not describe any specific structural arrangement of components on any specific device. It does not disclose a single entity on an insulin delivery device that integrates both a bolus calculator and a delivery controller. The Examiner's reliance on this paragraph to satisfy a specific structural claim limitation is misplaced. Second, Davis at paragraph [0099] describes the insulin delivery device (the pump) as a "passive device" that receives glucose values from the analyte sensor system. Paragraph [0099] states: "Medical device 136 may be a passive device in example embodiments of the disclosure. For example medical device 136 may be an insulin pump for administering insulin to a user." A passive receiver of data is structurally incompatible with a device that hosts a bolus calculator performing active dose determination. Davis's own characterization of the pump as passive forecloses the Examiner's mapping of dose-determination functions to the pump. Third, Davis at paragraph [0014] and the description of Figure 1A establish that the bolus calculator in Davis resides on a separate display device (namely, a CGM app on the patient's smartphone or dedicated display) that is distinct from the insulin delivery device. Figure 1A depicts system 100 as including separate analyte sensor system 8, display devices 110-140, medical device 136, and server system 134, all as distinct components in wireless communication. The bolus-calculator functionality is attributed to the display device component, not to medical device 136. Davis therefore does not disclose a single entity residing on the insulin delivery device that integrates both the bolus calculator and the delivery controller. Fourth, Davis at paragraph [0187] describes the bolus calculation trend adjustment as an HCP-configured parameter setting. Paragraph [0246] describes downstream notification functionality after bolus delivery. Neither paragraph discloses a structural arrangement in which a single entity on the insulin delivery device controls both dose computation and delivery actuation. The Examiner's mapping assembles these disparate paragraphs into a composite that Davis does not actually disclose (Remarks, pages 14-15). Examiner disagrees. Davis et al teaches a non-transitory computer-readable storage medium for storing computer programming instructions for a single entity that is in control of determining doses and causing delivery of the insulin to the user from the insulin delivery device (100) to the user (paragraph [0264]: Implementations of the subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a tangible and non-transitory computer readable medium for execution by, or to control the operation of, data processing apparatus)(paragraph [0099]: medical device 136 may be an insulin pump for administering insulin to a user, as shown in FIG. 1B. For a variety of reasons, it may be desirable for such an insulin pump to receive and track glucose values transmitted from analyte sensor system 8. One reason is to provide the insulin pump a capability to suspend or activate insulin administration when a glucose value falls below a threshold value), the single entity including: a bolus calculator for calculating the doses for insulin boluses to be delivered to the user (Figure 11), and a controller for controlling automated insulin delivery to the user (paragraph [0019]: bolus calculator settings/parameters may include a basal rate). System 100 is a single entity (Figure 1A) having a bolus calculator residing on display device 120 (Figure 11) and a medical device 136.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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