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 .
Response to Amendment
This office action is responsive to the amendments filed March 2, 2026.
Claims 1-8 have been amended
Claims 12-13 have been canceled
Claims 2-7 and 9-11 remain pending in their previously presented form
Claims 14-20 remain pending and unamended
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered. The arguments are persuasive in part and unpersuasive in part, as discussed below with respect to the individual rejection and claims.
Regarding claims 1-20, Applicant argues that all pending claims are directed to “technical solutions to technical problems” involving control of medicament delivery systems, that the claims address a real-world problem of individualized and dynamic insulin dosing, and that the claims do not “merely perform calculation” but instead make determinations used to adapt medicament delivery, particularly in amended claims 1 and 8 which now recite causing delivery of medicament at the determined dosage or rate.
In view of Applicant’s amendments adding explicit “causing delivery” limitations to claims 1 and 8 and the associated structural and control features recited in their dependent claims, the rejection under 35 U.S.C. §101 is withdrawn for claims 1-13. However, as discussed below, claims 14-20 remain rejected under 35 U.S.C. §101 because they are still directed to mathematical comparisons and presentation of information on a generic processor/display without additional elements that integrate the abstract idea into a practical application or amount to significantly more than the abstract idea itself.
Regarding claim 1, applicant argues that Desborough does not disclose “at least one adjustment restriction that restricts how much the new basal ratio may vary from the previous basal ratio.”
The argument is not persuasive.
Desborough discloses adjusting a baseline basal insulin rate (BBR) based on insulin actually delivered, and expressly discloses limiting the size of each daily adjustment by capping the magnitude of the change to no more than specified percentages (e.g. 10%, 5%, 3%, 2%, about 1%). See Desborough para [0093] stating that “ In some cases, adjustments to user-specific dosage parameters can be based on a threshold variation and/or can be limited to prevent excessive adjustments to user-specific dosage parameters. For example, in some cases, a daily adjustment to a user-specific dosage parameter can be limited to less than 10%, less than 5%, less than 3%, less than 2%, or to about 1%. . In some cases, an adjustment to a baseline basal rate is less than a difference between the amount of basal insulin actually delivered and the baseline basal for a specific period of time”
In the Examiner’s reading, the “previous basal ratio” corresponds to Desborough’s baseline basal rate for the relevant time period, the “new basal ratio” corresponds to the updated basal rate after adjustment, and Desborough’s explicit cap on the daily adjustment factor is an “adjustment restriction” that limits how much the updated basal ratio may differ from the previous basal ratio. Because Desborough discloses an adjustment restriction that restricts the amount by which the basal parameter may change from one iteration to the next, the limitation in question is met.
Accordingly, claim 1 remains anticipated by Desborough under 35 U.S.C § 102, and the rejection of claim 1 maintained.
Regarding claims 2, 4, and 6, which were not argued separately, they depend from claim 1 and likewise remain rejected under 35 U.S.C § 102 over Desborough for the reasons set forth for claim 1.
Regarding claims 3, 9, and 10, Applicant argues that the claims are patentable because they depend from claim 1, which Applicant asserts is not anticipated by Desborough.
As discussed above, the arguments regarding claim 1 are not persuasive. Because claim 1 remains unpatentable and Applicant has not rebutted the specific mapping and rationale for the additional limitations, the rejection of claim 3 under 35 U.S.C § 103 over Desborough in view of Lee is maintained. The status of claims 9 and 10, which now depend from allowable claim 8, are addressed below.
Regarding claim 7, Applicant contends that claim 7 is allowable because it depends from amended claim 1.
Applicant does not separately address the additional limitation of claim 7. As noted above, the rejection of claim 7 under 35 U.S.C § 103 over Desborough in view of Franke is maintained.
Regarding claim 8, in the prior office action, claim 8 was rejected under 35 U.S.C § 103 as being unpatentable over Desborough in view of El-Khatiib.
In the amendment files March 2, 2026, Applicant incorporated the limitations of claims 12 and 13 into claim 8, namely that updating the basal portion factor by a first predetermined fixed amount if the basal portion factor is below a threshold and decreasing the basal portion factor by a second predetermined fixed amount if the basal portion factor is above a threshold.
The cited prior art does not teach or suggest this particular fixed-increment, threshold-based update scheme for the basal portion factor.
Accordingly, the rejection of claim 8 under 35 U.S.C § 103 over Desborough in view of El-Khatiib is withdrawn.
Regarding claims 9-11, the withdrawal of the rejection of claim 8 under 35 U.S.C § 103 over Desborough in view of El-Khatiib puts claims 9-11 in a condition of allowance as they depend from claim 8.
Claims 14-20 remain rejected under 35 U.S.C § 101 as being directed to an abstract idea without significantly more, as set forth in the previous office action.
Applicant did not amend claims 14-20 and did not present any substantive arguments directed specifically to these claims in the reply of March 2, 2026.
Accordingly, the rejection of claims 14-20 under 35 U.S.C § 101 is maintained.
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 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claims recite mathematical concepts including [ratios of basal to total medicament, averages of daily components, weighted sums, thresholding and scaling], which fall withing the abstract-idea category of mathematical relationships/formulas. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are recited at a high level and amount to generic computer implementation. They do not improve computer or pump technology, are not tied to a particular machine beyond a generic controller, do not effect a transformation, and instead, represent insignificant extra-solution activity of implementing the formula on a generic system.
The identified claims and limitations that recite an abstract idea do fall within the enumerated groupings of abstract ideas in Section I of the 2018 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. Nonetheless, the claim limitations are being treated as reciting an abstract idea because individually and in combination, the additional elements are well-understood, routine, conventional in the field, as evidenced by admission in the specification that various components [pump/controller and processor/memory] may be used. Accordingly, the claims do not include an ‘inventive concept’ that amount to ‘significantly more’ than the judicial exception.
This Detailed Action will, therefore, proceed through the Alice/May test, as described in MPEP § 2106, subsection III, to show that the claims mentioned above, as drafted, are not eligible subject matter for a patent under 35 U.S.C. 101.
Regarding independent Claim 14
Step 2A, Prong One: The claim calculates averages and compares an “average meal bolus portion” against a “historical average” to generate display suggestions to increase or decrease bolus amounts by a percentage. These are mathematical comparisons and rules. The claim recites a mathematical concept.
Step 2A, Prong Two: The display and processor that “generate a suggestion” are generic and constitute mere presentation of information. There is no improvement to computer technology or particular machine. Neither is it integrated into a practical application.
Step 2B: Generating recommendations on a display based on computed ratios/averages is well-understood, routine, and conventional.
Evidence: Generating and displaying dosing suggestions based on computed average/ratios constitutes presentation of information on conventional displays and UI, which the specification describes as standard device/phone interfaces.
Dependent claims from claim 14 [claims 15-20]:
Those calculating historical averages and ratios for meal/basal/TDI are further math. Specifying that first and second percentages may be equal is a parameter choice.
Evidence: Statistical aggregations (average, sums, ratios) and configurable percentage display suggestions performed by generic processors/displays is standard in AID systems and is presented as such in the specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desborough (US Patent Application No 2017/0203039, hereinafter, Desborough).
Regarding claim 1, Desborough discloses a medicament delivery system (Desborough: para [0090], line 1) comprising:
a non-transitory storage for storing computer programming instructions (Desborough: Fig 5B (242); para [0180], lines 1-5); and
a processor for executing the computer programming instructions (Desborough: Fig 5B (241); para [0180], line 2), said computer programming instructions causing the processor to:
calculate a new basal ratio for a user that specifies what portion of total daily medicament for the user is to be delivered by basal medicament deliveries (Desborough: para [0152], lines 6-9) based on:
a previous basal ratio for the user (Desborough: para [0181], lines 26-29),
an adjustment (Desborough: para [0093], line 27) comprising:
a ratio of amounts of a medicament delivered as basal medicament deliveries to the user via an automated medicament delivery device over a period to a total amount of medicament delivered to the user over the period (Desborough: para [0181], lines 12-24]), and
at least one adjustment restriction that restricts how much the new basal ratio may vary from the previous basal ratio (Desborough: para [0093], lines 43-46);
determine a dosage for a next basal medicament delivery by the automated medicament delivery device to the user using the new basal ratio (Desborough: Fig 2 (262) para [0093], lines 1-9); and
cause the dosage of the next basal medicament delivery to be delivered to the user by the automated medicament delivery device (Desborough: para [0093]).
Regarding claim 2, Desborough discloses the medicament delivery system of claim 1, wherein the medicament is insulin (Desborough: para [0091], lines 1-6).
Regarding claim 4, Desborough discloses the medicament delivery system of claim 1, wherein at least one adjustment restriction includes a maximum and/or minimum value that the adjustment may assume. (Desborough: para [0093], lines 39-43)
Regarding claim 6, Desborough discloses the medicament delivery system of claim 1, wherein the at least one adjustment restriction is a scaling factor that scales the adjustment. (Desborough: para [0093] lines 39-43)
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 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Desborough in view of Lee (US Patent Application No 2022/0280721, hereinafter, Lee).
Regarding claim 3, Desborough discloses the medicament delivery system of claim 2, but fails to disclose that the determining the dosage for the next basal medicament delivery comprises multiplying a total daily insulin for the user by the new basal ratio.
Lee, however, teaches that the determining the dosage for the next basal medicament delivery comprises multiplying a total daily insulin for the user by the new basal ratio (Lee: para [0042-0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump/controller of Desborough to compute the next basal dosage as TDI multiplied by an updated basal portion (ratio), as taught by Lee, in order to use the product (TDI x updated basal portion) to obtain the next basal amount and yield predictable results when converting a daily proportion into an absolute basal dose.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Desborough in view of Franke (US Patent Application No 2019/0282752, hereinafter, Franke).
Regarding claim 7, Desborough discloses the medicament delivery system of claim 1, but fails to disclose that the medicament includes at least one of a glucagon like peptide-1 (GLP-1) agonist, pramlintide or another agent that affects a glucose level of the user.
Franke, however, teaches that the medicament delivery system of claim 1, wherein the medicament includes at least one of a glucagon like peptide-1 (GLP-1) agonist, pramlintide or another agent that affects a glucose level of the user (Franke: para [0055] Lines 10-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicament delivery system of Desborough to include delivery of additional glucose-affecting agents (e.g. a GLP-1 agonist or pramlintide), as taught by Franke, in order to administer insulin with agents that affect glycemia, including GLP-1 receptor agonists and pramlintide.
Allowable Subject Matter
Claims 5 and 8-11 are pending and allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 5, the closest prior art is Desborough.
Desborough discloses the medicament delivery system of claim 1, wherein the at least one adjustment restriction limits a difference between the previous basal ratio and the new basal ratio. Desborough discloses limiting adjustments using percentage magnitudes rather than a single predetermined fixed difference between successive basal ratios.
Other prior art or record fails to teach or suggest these predetermined fixed-amount adjustment restrictions. Accordingly, claim 5 is allowed.
Regarding claim 8, the closest prior art is Desborough in view of El-Khatiib.
Desborough discloses a medicament delivery system (Desborough: para [0090] line 1) comprising:
a non-transitory storage for storing computer programming instructions Desborough: Fig 5B (242); para [0180] lines 1-5);
a processor for executing the computer programming instructions (Desborough: Fig 5B (241); para [0180] line 2), said computer programming instructions causing the processor to:
determine an average amount of insulin delivered to a user per day to compensate for carbohydrates ingested in meals; (Desborough: para [0181] lines 18-24)
determine an average amount of insulin delivered to the user per day to correct for high glucose experienced by the user; (Desborough: para [0181] lines 18-24)
determine an average amount of insulin delivered by the user as basal deliveries; (Desborough: para [0181] lines 18-24)
compute the sum of the average amount of insulin delivered to a user per day to compensate for carbohydrates ingested in meals, the average amount of insulin delivered to the user per day to correct for high glucose experienced by the user and the average amount of insulin delivered by the user as basal deliveries; (Desborough: para [0834] lines 15-19)
determine a basal portion factor as a ratio of the average amount of insulin delivered by the user as basal deliveries to the sum (El-Khatiib: para [0834] lines 3-5), para [0835] lines 1-3, para [0836] lines 1-2);
cause the insulin to be delivered from the medicament delivery system to the user at the updated basal delivery rate (Desborough: para [0093]).
Desborough fails to disclose updating the basal portion factor by increasing it by a first predetermined fixed amount when below a threshold and decreasing it by a second predetermined fixed amount when above a threshold.
Other prior art or record fails to teach or suggest first predetermined fixed amount or the second predetermined fixed amount as a result of increasing or decreasing the basal portion factor based on the basal portion factor. Accordingly, claim 8 is allowed.
Claims 9-11 depend from claim 8 and are allowed for a least the same reasons of claim 8.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571)272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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, Michael Tsai can be reached at (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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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783