DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 01/15/26 have been entered in the case. Claims 21-25, 27-30 & 36 are pending for examination and claims 1-20, 26, 31-35 are cancelled.
Claim Rejections - 35 USC § 112
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.
Claims 21-25, 27-30 & 36 are 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.
Nowhere in the original specifciaotn has described the limitation that: cause the meal bolus to be delayed time from when the meal has been consumed in response to the user having a glucose level below the threshold, as recited in claim 21. Examiner acknowledges that the meal bolus to be delayed time when the user having a glucose level below the threshold. Examiner also acknowledges that when the glucose level below the threshold, the meal should be consumed.
However, the original specification does not mention that the meal bolus is to be delayed when (at the same time) that the meal has been consumed.
Claims 22-25 are being rejected due to their dependency.
In claim 27, nowhere in the original specification has described that: the processor configured to determine that the use has delayed gastric emptying, as recited in claim 27. The para [0040] states that: ... the controller 205 includes an indication whether the user has abnormal gastric emptying. .... The indication of abnormal gastric emptying may be stored in a memory communicatively coupled to the controller 205.
Having said in the para [0040] above, the indication (not a processor) determines that the user has abnormal gastric emptying.
The claim 27 is being rejected with the same analysis as noted above. Nowhere in the original specification has mentioned that the meal bolus is to be delayed when (at the same time) that the meal has been consumed). Please see the explanation in the claim 21 above.
In addition, nowhere in the original specification has described that: ... cause at least a portion of the meal bolus to be delivered a delayed time from when the meal has been consumed... The term “at least a portion of the meal bolus to be delivered a delayed time” is understood that at least or a little amount of the meal bolus to be delivered. However, the Fig. 6 shows that the time period t1-t2 (empty stomach), there is no bolus meal is delivered.
Claims 27-30 & 36 are being rejected due to their dependency.
In claim 36, the limitation “the processor is configured to determine that the user has delayed gastric emptying by accessing an indication that the user has delayed gastric emptying stored in the memory” is failing to comply with the written description requirement.
The para [0040] in the original specification states that: According to some embodiments, the information related to managing diabetes received by the controller 205 includes an indication whether the user has abnormal gastric emptying. ... The indication of abnormal gastric emptying may be stored in a memory communicatively coupled to the controller 205. The insulin timing module 225 may delay delivery of meal bolus when abnormal gastric emptying is indicated for the user.
Having said in the para [0040] above, an indication of abnormal gastric emptying is determined by the controller (but not the processor); then the insulin timing module of the controller delays delivery of the meal bolus when the user is indicated for an abnormal gastric emptying condition.
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 pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 21-25 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipate by Hellwig et al. (US 7,291,107).
Regarding claim 21, Hellwig discloses an infusion pump system 10, comprising:
a pump mechanism (insulin pump, col. 6, lines 69-63) configured to facilitate delivery of insulin to a user;
a user interface (display 16/34);
a communications device 14/18 (Fig. 1) adapted to receive one or more glucose levels from a continuous glucose monitor (col, 6, lines 69-66);
a processor, i.e., microprocessor-based control computer, functionally linked to the pump mechanism, the user interface 16, 18, 36 and the communications device (control circuit 14/32 or/and elements 40, 42, 44),
Note: the insulin pump or automatic insulin dosing or administering unit, col. 6, lines 60-63. In other words, the automatic insulin pump is including a processor functionally linked to the pump mechanism for controlling of delivering a drug.
the processor configured to:
receive input 18/36 (col. 2, lines 4-9) through the user interface (display 66 in Fig. 2I, also see col. 5, line 1-4) programming a meal bolus (an insulin bolus recommendation) , the meal bolus calculated to be an amount of insulin configured to counteract a number of carbohydrates consumed in a meal (e.g., a correction bolus dosage after meal blousing, as shown in Figs. 2I-2K), also see steps 106-110 in Fig. 3A; a display 80 in Fig. 4A shows a number of carbohydrates consumed, see steps 112 in Fig. 5; displays 88 & 90 in Figs. 4E-4F);
determine that the user has a glucose level below a threshold (see Figs. 2L, 4B-4C); and
cause the meal bolus to be delayed time from when the meal has been consumed in response to the user having a glucose level below the threshold (e.g., the Fig. 4B shows that the glucose level below a threshold, i.e., 60md.dl, and the user has to intake fast carbohydrate to avoid hypoglycemic. At this time, no insulin is delivered. In other words, the meal bolus is to be delayed, i.e. MB = 0, also see steps 116, 180 & 190 in Fig. 7; steps 118, 200, 202, 204 & 206 in Fig. 8A).
Regarding claims 22-23, wherein the processor is configured to automatically adjust the amount of insulin (correction bolus) in the meal bolus due to the user's glucose level going of the user being below the threshold; or based at least in a part on the glucose level of the user (either low or high blood glucose level).
Regarding claim 24, wherein the processor is further configured to receive input through the user interface indicating a timing of the meal around T1, see col. 22, lines 3-5
Regarding claim 25, wherein the processor is configured to automatically adjust the amount of insulin in the meal bolus (second recommended correction insulin bolus quantity) to an adjusted amount at least in part based on an amount of insulin previously delivered to the user (e.g. a first recommended correction insulin bolus), col. 2, line 42-col. 3, line 4.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060).
Regarding claim 21, Steil discloses an infusion pump system, in Figs. 1-2 comprising:
a pump mechanism 48, in Fig. 5, configured to facilitate delivery of insulin to a user;
a user interface (display, paras [0058, 0066], or user-specific input variables, para [0045]; a manually input into a controller 12 via commands 12, para [0089] & Fig. 1; the user may wish to input a different "type" of meal, para [0134]);
a communications device 12 adapted to receive one or more glucose levels from a continuous glucose monitor 10 (para [0054], the glucose sensor system 10 generates a sensor signal 16 representative of blood glucose levels 18 in the body 20, and provides the sensor signal 16 to the controller 12);
a processor (a computer implemented process, para [0044], or a programming) functionally linked to the pump mechanism (via infusion pump 14 in Fig. 1 or element 34 in Fig. 5), the user interface and the communications device 12. Note: the infusion pump system in Steil is used for automated closed loop continuous insulin delivery. Therefore, the infusion pump system is inherently including a processor (via programming, software, or algorithms) to link with the pump mechanism, the user interface and the communications device, see Fig. 1.
Fig. 15a shows historical insulin delivery and consumed meal data. Fig. 15b shows predicted and sensor glucose data. Therefore, the processor in Steil is configured to:
receive input through the user interface (via display, as shown in Figs. 15a-15b) programming (via algorithm) a meal bolus 203 (e.g., amount of insulin delivery 203 is equivalent to a meal bolus, see Fig. 15a; the algorithm starts at block 200, wherein historical meal-type, indicator for each meal consumed by a user is stored; at block 210, store historical insulin- delivery information, i.e., meal bolus including, for each instance of insulin delivery, an insulin amount and a delivery pattern, see steps 200-210); the meal bolus 203 calculated to be an amount of insulin (by a model predictive control - MPC) configured to counteract carbohydrates 201 consumed in a meal, i.e., the historical meal (steps 200-220, and Fig. 15a);
determine that the user has a glucose level below a threshold (below value 70 mg/dl).
Note: a person skilled in the art would recognize that the blood glucose level is below 70 mg/dl considered as a threshold for low blood glucose level. In this case, the Fig. 15b shows that the blood glucose level is about 50 mg/dl 2 11:30am. At that time, no bolus is delivered. And at same time, a meal 201 has been consumed in response to the user having a glucose level about 55 mg/dl that below the threshold 70mg/dl.
Cause the meal bolus 203 to be delayed (at a delayed time around 11:30-12:15, in Fig. 15a, also see marked-up Figs. 15a below) when the meal 201 has been consumed (around at 11:30-11:45) in response to the user having a glucose level (55mg/dl, see Fig. 15b) below the threshold (70 mg/dl).
Note: The Fig. 6 in the original specification of the current application states that the delayed time is in between t1-t2 with no drug. Therefore, with broadest interpretation, Examiner assumes that the delayed time happens when no drug is delivered.
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Having that said above, the delayed time happens when no drug is delivered. In this case, Steil shows in Fig. 15a that when the meal 201 has been consumed (at time period 11:30-11:45) in response to the user having a glucose level (about 55 mg/dl) below the threshold (70mg/dl); and the time period of no drug is delivered or equivalent to claimed “delayed time” is about 11:30 to 12:15, see marked-up Fig. 15a below:
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As seen in Figs. 15a-15b, the amount of insulin delivery (line 203 in Fig. 15a) is correlated with a glucose concentration (in Fig. 15b, in model predicted glucose 205, sensor glucose value 207 or meter value 209). For example: in Fig. 15b, after 9am, the glucose concertation value is about 250 mg/dl and therefore, a large amount of insulin delivery introduces into a patient to bring down the glucose concentrate level in normal range. Around at 11:30am, the glucose concentration value declines in dangerous level (about 55 mg/dl, in Fig. 15b). At this time 11:30 am, the meal bolus is delayed (see box A, in marked-up Fig. 15a, no drug delivery), the meal 201 has been consumed in response to the user having a glucose level (55mg/dl) below the threshold (70mg/dl) to avoid hypoglycemia condition in the patient.
For further explanation, the glucose concentration in Fig. 15b correlates with the historical insulin delivery and consumed meal data in Fig. 15a, see line A in the marked-up Figs 15a-15b below.
For example: As seen in Fig. 15b, around 11:30am, the glucose level is about 55 mg/dl that below the threshold 70 mg/dl and that will cause patient at risk in hypoglycemia condition. At this time, the meal bolus = 0 amount of insulin, the carbohydrate content 201 consumed in between 11:30- 11:45, the process generates a predicted glucose concentration profile a model predictive (MP) controller based on the historical meal (201, in Fig. 15a) and insulin-delivery information, see step 220 in Fig. 14. The delayed time at 11:30-12:15, the glucose concentration is below a glucose threshold, therefore, the adjusted amount of meal bolus during the delayed time period is zero amount of insulin, as shown in Fig. 15a. Around the time @12:15 or 12:30, the blood glucose starts to incline after carbohydrate meal was consumed. At this time, the meal bolus starts to kick in slowly increase so that to keep the blood glucose in target value.
Regarding claim 22, wherein the processor is configured to automatically adjust the amount of insulin in the meal bolus (at zero amount of insulin) to reduce a likelihood of the user's glucose level going below a low glucose threshold.
Regarding claim 23, wherein the processor is configured to automatically adjust the amount of insulin in the meal bolus based at least in a part on a current glucose level of the user (via sensor glucose 207 and/or meter value 209, as shown in Fig. 15b).
Regarding claim 24, wherein the processor is further configured to receive input through the user interface indicating a timing of the meal (see block 201 in Fig. 15a).
Regarding claim 25, wherein the processor is configured to automatically adjust the amount of insulin in the meal bolus 203 to an adjusted amount at least in part based on an amount of insulin previously delivered to the user, see step 220 in Fig. 14.
Response to Arguments
Applicant's arguments filed 12/19/25 have been fully considered but they are not persuasive.
Applicant states that there is no teaching or suggestion in Steil that a meal bolus is programmed and delivery of the meal bolus is delayed specifically because the user’s glucose level is below a threshold, as required in the claim 21.
In response, Steil shows that the glucose concentration in Fig. 15b correlates with the historical insulin delivery and consumed meal data in Fig. 15a, see line A in the marked-up Figs 15a-15b below; wherein a meal bolus is delayed (no drug delivered at 11:30-12:15, in Fig. 15a) is delayed because the user’s glucose level (55 mg/dl) is below a threshold (70 mg/dl). Also see the rejection above for more details.
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Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 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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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783