DETAILED ACTION
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2, 4-7, 9, 11-12, 14, 16-20, and 22-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) modifying an insulin delivery profile using a patient specific parameter. This limitation covers performance of the limitation in the mind but for the recitation of generic computer components. Accordingly, it falls within the “Mental Processes” grouping of abstract ideas.
This judicial exception is not integrated into a practical application because there is no further application of the abstract idea once the adjustment of the insulin delivery profile has been determined. The use of a processor to determine the modification amounts to no more than mere instructions to apply the exception using a generic computer component.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The use of a generic analyte monitor is merely an incorporation of a generic device within an insignificant extra-solution activity of data-gathering and does not amount to significantly more than the abstract idea. The claims are not patent eligible.
The examiner notes that claims 10 and 15 recite the actual administration, by an insulin delivery device, the adjusted insulin delivery profile. As such, these limitations incorporate a practical application to the abstract idea and are considered to be patent eligible.
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 2, 4-7, 9-12, 14-20, 22-24 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.
Claims 2, 12, and 20 recite administering insulin to a user according to an insulin delivery profile “or to administer insulin as one or more bolus insulin doses”. Accordingly, it does not necessitate that the insulin delivery device be configured to provide insulin as one or more bolus insulin doses. However, the claims then go on to specify that the patient specific parameter comprises “information about the one or more bolus insulin doses administered”. As the one or more bolus insulin doses is not necessarily required, it is unclear what it means for the patient specific parameter to comprise such information when it is not required. Accordingly, it is unclear whether then the insulin delivery device must be configured to administer bolus insulin doses, or if not, what the patient specific parameter becomes, whether it’s simply a null value or something else entirely, and how a modification to the insulin delivery profile can be done in either case. For purposes of interpretation, it will be understood that the insulin delivery device IS necessarily configured to administer insulin as one or more bolus doses.
Claim Rejections - 35 USC § 102
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2, 4-7, 9-12, 14-20, 23-24 is/are rejected under pre-AIA 35 U.S.C. 102(a) and (b) as being anticipated by Steil et al. (US 2003/0130616).
As to claims 2, 12, 18, and 20, Steil teaches a method, corresponding device, and programming for modifying an insulin delivery profile, the method comprising: monitoring analyte levels by an analyte monitor (10) over a predetermined period of time in which an insulin delivery device is configured to administer insulin to a user according to an insulin delivery profile ([0292] – the device can be configured with a basic basal rate/boluses, etc) or to administer insulin as one or more bolus insulin doses ([0073-0074]), wherein the analyte monitor comprises a transcutaneous analyte sensor ([0317]) and a transmitter (30); retrieving, by a processor (12) in communication with the analyte sensor and being part of the infusion pump (Fig. 3), the insulin delivery profile and a patient specific parameter during the predetermined period of time, wherein the patient specific parameter comprises information about the one or more bolus insulin doses administered over the predetermined period of time ([0090], [0166-0169], [0211]), determining a modification to the insulin delivery profile based on the patient specific parameter ([0090]), and adjust the insulin delivery profile based on the determined modification ([0080]). The examiner notes that as Steil teaches a closed-loop infusion system in which both glucose measurements and insulin delivery information is used to create an iterative system to adjust future infusions of insulin (Fig. 1; [0166-0169]), it results in the use of a patient specific parameter to determine modifications and adjust the delivery profile on said modification.
As to claims 4-5, 8, 14, and 21, Steil teaches the patient specific parameter comprises information associated with bolus insulin delivery, frequency and timing, and basal and bolus insulin delivery (inherent as all previous delivery of insulin is utilized in the closed loop system; see also ([0211] and [0166-0169]).
As to claim 6, Steil teaches the parameter comprises an insulin sensitivity factor ([0089] – accounting for insulin sensitivity).
As to claim 7, Steil teaches the parameter comprises a level of insulin on board ([0117]).
As to claim 9, Steil teaches the period of time comprises one or more days ([0303]).
As to claims 10, 15, and 16, Steil teaches administering the adjusted insulin delivery profile ([0092]) using an insulin delivery device ([0004]).
As to claims 11 and 17, Steil teaches the device is an infusion pump ([0004]).
As to claim 19, Steil teaches a receiver in communication with the analyte monitor comprises the processor ([0340]).
As to claim 23, Steil teaches the analyte monitor is a glucose monitor (Abstract).
As to claim 24, Steil teaches outputting, on a display in communication with the processor, the modification to the insulin delivery profile based on the patient specific parameter comprising information about the one or more bolus insulin doses.
Claim Rejections - 35 USC § 103
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.
Claim 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2003/0130616).
As to claim 22, Steil does not teach that the predetermined period of time is 72 hours. Instead, Steil teaches a predefined time window over which the glucose values are evaluated for the adjustment of controller gains ([0168]). However, it teaches that alternative embodiments can be made in which a moving time window is used, as short as one hour, or in other alternative embodiments, the time window is longer or shorter than the 24 hours depending on various factors. Accordingly, it would have been obvious to modify Steil to use a predetermined time period of 72 hours, as the use of such a period can be obtained with simple optimization within the prior art conditions of Steil or through routine experimentation. Moreover, there does not appear to be a specific criticality to the use of 72 hours which would make such a modification non-obvious.
Response to Arguments
Applicant's arguments filed 8/22/25 have been fully considered but they are not persuasive.
As to the 101 rejection, applicant has argued that the incorporation of outputting the adjusted insulin delivery profile to the insulin delivery device for administration, along with the other amendments as being an improvement to the insulin delivery systems. However, as a prior art rejection is still applied, no such improvement can be asserted as it has yet to even demonstrate novelty and/or non-obviousness. Applicant has also argued that the output of the adjusted insulin delivery profile to the insulin delivery device for administration implements a treatment and would thus be integration of a practical application. However, as previously noted by the examiner, claims 10 and 15 were not subject to the 101 rejection because it actively recites the treatment step itself by reciting the active administration or causing of the administration. In contrast, the output of the adjusted profile to the delivery device does not “affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition” to be considered a particular treatment or prophylaxis (see MPEP 2106.04(d)(2)). Accordingly, the 101 rejection still applies for the applicable claims.
As to the prior art rejection, applicant has asserted that Steil fails to disclose a system that obtains information about bolus insulin doses in addition delivered according to an insulin delivery profile over a predetermined period of time, and then modifying the insulin delivery profile based on that bolus insulin information. As noted in the above rejection, Steil teaches that the delivery system provides “finite insulin doses” into the body in response to commands from the controller ([0211]). Each finite insulin dose is in effect an individual bolus that is administered to the user. Steil also teaches that the glucose levels are monitored over a predetermined period of time, and then utilized to the controller gains for adjusting insulin amounts ([0166-0169]). This also further provides support to examiner’s assertion that the feedback loop taught by Steil must necessarily base its decisions on modifying future doses of insulin on the past knowledge of applied insulin which is correlated to current glucose measurement values as the controller gains are “self-tuned” to account for things like changes in insulin sensitivity ([0167]). Accordingly, the rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 10/16/25
