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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 (“RCE”), including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 February 2026 (“Reply”) has been entered.
Response to Amendment
This Action is responsive to the RCE and Reply. As directed in the Reply:
Claims 1, 8-11, and 14 have been amended;
Claims 4-7, 12, 13, 16, 18, and 19 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1, 3, 8-11, 14, 15, 17, and 20 are presently pending in this application, with no claims having been previously withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to Claims 1, 3, 8-11, 14, 15, 17, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because, in the paragraph beginning with “activate a temporary,” at the second line, the word “unreliable” is missing (the claim has been treated as including that word).
Correction is required.
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 1, 3, and 8-11 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.
Claim 1 has been amended to recite, among other things, that “the at least one processor [is] configured to . . . “activate a temporary basal profile configured to be used in the closed loop mode during a period when the glucose levels are considered [sic: add “unreliable].” Applicant identifies (Reply, pg. 7, line 2) paragraph [0033]1 as providing support for this feature. The Examiner has reviewed the entire application as originally filed, and finds no written description support of this feature.
The application as-filed is silent concerning this feature, that the temporary basal profile is closed loop; indeed, the salient portions of the Specification indicate that it is open loop, or the disclosure is silent whether it is open or closed. As recently pointed out in Novartis Pharms. Corp. v. Accord Healthcare, Inc., et al., no. 2021-1070, slip op. at 5 (Fed. Cir., June 21, 2022), disclosure of a claimed feature is the focus of sec. 112(a), and that “[s]ilence is generally not disclosure” (citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)). “While a negative limitation need not be recited in the specification in haec verba, there generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives” (id.). A full review of the application as-filed reveals nothing that conveys that the inventors intended to exclude open or hybrid loop control for the temporary basal profile, for those passages in the Specification where it does not specify that the control utilizes an open, hybrid, or closed loop. For example, the Specification states:
In light of the above, systems and methods disclosed herein provide adaptive profiles in which a user can maintain a separate, stored basal profile that is applied during CGM warmup periods when glucose levels are not available from the CGM. To avoid potential undesirable fluctuations in glucose, this “warmup profile” can be configured to maintain the user’s glucose levels within a wider and higher range than the stored profile used as the baseline during closed loop delivery. Reverting to this profile is different from reverting to a default open loop basal profile because it is designed specific for CGM warmup periods when CGM based closed loop therapy will begin in the near future, rather than being used any time the pump is not in a closed loop mode. In addition, in some embodiments the system may use the CGM values measured during the warmup period to automatically adjust delivery, with the more conservative CGM warmup profile providing a safeguard against the unreliability of the CGM data during this period. The system can then revert to the stored basal profile for closed loop therapy once standard closed loop delivery is resumed following the CGM warmup period. In some embodiments, the system can automatically revert to the stored profile upon detecting that a CGM warmup period has been completed.
(Specification, pg. 11, line 14 to pg. 12, line 6; emphasis added). The Specification also states the following:
When the CGM sensor expires at step 304, the system automatically reverts to open loop therapy at step 306. At step 308, a new CGM sensor is inserted to initiate a new CGM session, which will require the sensor to go through a warmup period in which glucose levels are not available and/or too unreliable for closed loop therapy. When the CGM session is initiated, rather than activating the default basal profile for closed loop, the system activates a warmup profile at step 310 designed for use during the CGM warmup period that is less aggressive than the default basal profile. In some embodiments the system delivers therapy directly based on the warmup profile, whereas in other embodiments the system may vary delivery based on glucose levels measured during the warmup period with the less aggressive warmup profile accounting for the unreliability of the CGM data during this period.
(Specification, pg. 12, lines 11-21). This passage does not positively state that the warmup profile is open or closed loop, and strongly infers that it is open loop, because the process advances to step 306, open loop therapy, and then, “at step 314 closed loop therapy is reactivated using the default basal profile.” Lastly, paragraph [0033] of the patent application publication for this application discusses Fig. 6, which is at best agnostic about the nature of the control (closed, open, or hybrid), and suggests that it is not closed (“Once CGM communications are reestablished with available and reliable data at step 408, closed loop therapy is reactivated at step 410 using the default basal profile.”). Taken together, the originally filed Specification does not expressly state that temporary basal profile is used in a closed loop mode, and also does not exclude the use of open and/or hybrid loop modes of control, at least in part because the Specification is silent on the point.
Therefore, the foregoing limitation of Claim 1 does not find written description support in the application as-filed, is new matter to this application (35 U.S.C. § 132), and therefore there is no evidence that, as of the filing date of the application, the inventors had possession of the entire scope of Claim 1. The remaining claims depend from and therefore inherit this deficiency, without curing it, and are therefore also rejected on the same grounds.
Claim Rejections - 35 USC § 103
Claims 14, 15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2016/0030669, by Harris et al. (“Harris”) in view of U.S. Patent App. Pub. No. 2017/0182248, by Rosinko (“Rosinko”), U.S. Patent App. Pub. No. 2021/0236729, by Kiani et al. (“Kiani”), U.S. Patent App. Pub. No. 2016/0331898, by Damiano et al. (“Damiano”), and U.S. Patent App. Pub. No. 2017/0252513, by Buck, Jr., et al. (“Buck”).
Harris describes a device substantially as claimed by Applicant, as follows.
Claim 14: An ambulatory infusion pump system (12), comprising:
a pump mechanism (12) configured to deliver insulin to a user ([0018]);
a communications interface configured to receive data indicative of glucose levels of a user ([0020]) detected by a continuous glucose monitoring (CGM) sensor (100); and
at least one processor (42) configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels ([0020]), the at least one processor configured to:
cause insulin to be delivered according to a closed loop mode that determines at least some therapy parameters for the user based on a default closed loop basal profile and varies a basal rate from the default closed loop basal profile based on the glucose levels to maintain the glucose levels within a closed loop target range ([0025]).
It does not, however, describe that the processor is configured to:
detect that the CGM sensor will be or is expiring;
determine that a new CGM sensor has been inserted;
cause insulin to be delivered according to a CGM warmup profile during a warmup period of the new CGM sensor according to glucose levels measured by the new CGM sensor during the warmup period, wherein the CGM warmup profile is configured to maintain the user's glucose levels within a wider target range than a target range of the default closed loop basal profile; and
reactivate the default closed loop basal profile of the closed loop mode following completion of the warmup period.
Rosinko relates to ambulatory infusion pump systems having closed loop and open loop infusion control schemes (Abstract) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Rosinko teaches that the processor such a system can instead be configured to (in the service of providing uninterrupted insulin therapy to the patient):
detect that the CGM sensor will be or is expiring (312 in Fig. 6, [0036] “failure of a user to replace a CGM sensor within the recommended expiration period (e.g., a number of days) such that the CGM sensor has lost adequate accuracy”, [0043] “expiration of sensor”);
cause insulin to be delivered according to a CGM profile (316, open loop profile); and
reactivate the default closed loop basal profile of the closed loop mode following completion of ([0035], indicating that use of the open loop mode is as a “temporary suspend feature”) the warmup period.
Kiani relates to ambulatory infusion pump systems using CGM sensors and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Kiani teaches ([0004]) that, “[t]he separate glucose sensor provides redundancy for the system to ensure continuous monitoring when one of the glucose sensors is in a warmup period, a stabilization period, or an end of life period . . . ,” and thus that each of these periods are when the CGM’s data should be considered unreliable by the processor and should thus not be used in determining insulin delivery to the patient from the pump (see also [0154], [0198], [0212], [0213]), in order to more safely deliver insulin to the patient. Kiani also teaches the processor of such systems is configured automatically activate the closed loop mode upon an expiration of the warmup period ([0198], “the user will virtually never be out of closed loop during a warmup time or any other uncertain period;” [0204], “This consistency may allow for avoidance of non-measurement periods or moments in time where closed loop would otherwise be unavailable due to follow-up devices placement in warmup time;” [0215], “In this way, the first pump can entirely deplete its insulin reservoir so that no insulin is wasted, and the second pump can seamlessly continue where the first pump left off.”).
It 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, to design Harris’s device such that the at least one processor is configured to consider the glucose levels to be unreliable during a warmup period for the CGM sensor, and to automatically activate the closed loop mode upon an expiration of the warmup period, because Kiani teaches that the data from a CGM sensor during warmup, among other states, is unreliable and should not be used for determining insulin delivery to the patient, in order to more safely deliver insulin to the patient, and Kiani also teaches using a closed loop mode for insulin delivery after the CGM has warmed up and stabilized, in order to better control insulin delivery to the patient. Kiani’s thus discloses that the processor is configured to:
determine that a new CGM sensor has been inserted; and
cause insulin to be delivered according to a CGM warmup profile during a warmup period of the new CGM sensor.
It 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, to configure Harris’s processor to perform the foregoing steps of Claim 14, because Rosinko and Kiani teach doing so in very closely related devices, in order to provide continued insulin therapy to a patient upon detection of an expiring glucose sensor, installation of a new sensor, and its warmup.
Concerning the clause “wherein the CGM warmup profile is configured to maintain the user's glucose levels within a wider target range than a target range of the default closed loop basal profile,” Damiano relates to ambulatory infusion pump systems having online and offline infusion control schemes ([0023]) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Damiano teaches that the offline control scheme (the claim’s “temporary basal profile”) can be designed to maintain the user's glucose levels within a wider target range than a target range of the default closed loop basal profile (euglycemic band is 70-120 mg/dl; Fig. 4 and [0036]) (Damiano Claim 4, stating “offline operation including . . . correction dosing operations each including administration of a correction dose of insulin . . . a first target glucose level or range higher than a second target glucose level or range assumed during online operation”; [0040], discussing administration of less insulin than necessary to reduce BG than the online scheme), in order to maintain the patient’ s BG at an acceptable level. While Damiano does not discuss the lower limit of its first target glucose level, as a scalar, there are only three options: higher, lower, or the same as that of the online scheme. Taken with its higher upper target limit, this means that the ‘width’ of Damiano’s range is, respectively: unknown; wider; and wider. The Examiner immediately envisages (of the genus of lower limits; see M.P.E.P. § 2144.08(II)(1)(A)(iv)(a)) one of the two species of the lower limit as the selection of a low limit resulting in a wider target range for the offline scheme than a target range of the default closed loop basal profile. Similarly, for Claim 3, the Examiner immediately envisages the third species (lower limit in the offline mode is higher).
It 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, to design Harris-Rosinko-Kiani’s control scheme so that the temporary basal profile is configured to maintain the user's glucose levels within a wider target range than a target range of the default closed loop basal profile, and that a lowest glucose level and a highest glucose level in the wider target range are both higher than a lowest glucose level and a highest glucose level of the target range of the closed loop basal profile, because Damiano expressly describes using a higher upper limit for the target range, the Examiner immediately envisages two of the three species of possible lower limits, and thus that the two known ranges are wider than that of the online control scheme, all in service of maintaining the patient’s BG level within a medically acceptable range until online mode can resume.
Concerning the limitation, “according to glucose levels measured by the new CGM sensor during the warmup period,” Buck relates to ambulatory infusion pump systems having closed loop and open loop infusion control schemes (Abstract) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Buck teaches that the processor of such a system causes insulin to be delivered in varying amounts according to the temporary basal profile based on the unreliable CGM glucose levels ([0030], uses unreliable CGM data with a probability score to adjust gain of a statistical filter on the data, which varies the processor’s output; [0046], uses unreliable data from a CGM despite it being unreliable - “minimize the effect of glucose sensor malfunction, glucose sensor noise or poor sensing quality so as to provide an accurate estimate the actual glucose level of the person even in the presence of glucose sensor malfunction, sensor noise and/or poor sensing quality.”), so that the system can still function in a closed loop mode despite inaccurate CGM data from a single sensor, and thus continue to provide insulin therapy to the patient, without the need to use open loop mode and without the need for a second glucose sensor to be used at the same time.
It 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, to design the processor of Harris-Rosinko-Kiani’s-Damiano’s device to cause insulin to be delivered in varying amounts according to the temporary basal profile based on the unreliable glucose levels, because Buck teaches doing so in a very closely related device, in order to continue to provide insulin delivery therapy to a patient in a closed-loop mode despite unreliable data from the CGM and not enter open loop mode.
Claim 15: (The ambulatory infusion pump system of claim 14,) wherein the CGM warmup profile is a modification of the default closed loop basal profile (Kiani: profile used while new CGM is warming up is one based on prior infusion data from replaced CGM operating in closed loop mode).
Claim 17: (The ambulatory infusion pump system of claim 14, wherein a lowest glucose level and a highest glucose level in the wider target range are both higher than a lowest glucose level and a highest glucose level of the target range of the closed loop basal profile (see discussion above concerning Damiano and these features).
Claim 20: (The ambulatory infusion pump system of claim 14,) wherein the at least one processor is configured to cause insulin to be delivered according to a default open loop basal profile that is not varied based on glucose levels between when the CGM sensor expires and when the new CGM sensor is inserted (Kiani: insulin is delivered using a closed-loop scheme without regard to the unreliable data from the replaced CGM or the warming up CGM, id.).
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 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, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
1 The originally filed Specification did and does not include paragraph numbering, and Applicant does not indicate in the Reply that it refers to some other version of the Specification, leaving the Examiner to guess that Applicant refers to the published version of the application, U.S. Patent App. Pub. No. 2025/0170330.
Prosecution Insights