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 .
Response to Amendment
This office action is responsive to the amendment filed on 02/25/2025. As directed by the amendment: Claims l , 4, 5, 6, 9-14 and 16 have been amended, no claims have been cancelled, and no claims have been added.
Thus, claims 1-20 are presently pending in the application wherein
claims 17-20 are withdrawn.
Applicant's amendments to the claims have overcome every 112 claims rejection
previously set forth in the Final Office Action mailed 10/21/2025.
Response to Arguments
Applicant's arguments filed on 01/05/2026 have been fully considered but they are not persuasive.
In response to the arguments that “None of Wu, Doyle, Gass, or Mazlish, disclose, teach, or suggest a controller configured to "ascertain, in response to the indication of the type of diabetes being Type 2 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug for Type 2 diabetes mellitus."”, examiner respectfully disagrees. Mazlish teaches a system that can be used by a type 1 or 2 diabetes patient and the operation of the controller is influenced by the administration parameters (indication of the types of diabetes being type 1 or 2) that influence the controller to specify a target amount of medicine to deliver; a frequency of delivery; and/or conditions, constraints, or algorithms for deviating a medicine administration from the target amount of medicine (for instance the upper boundary constraint) based on inputs from the sensor 3 (see column 10, lines 45-56 of Mazlish).
With regard to the arguments that “Mazlish does not teach or suggest a system that receives an indication of diabetes type, responding differently based on diabetes type, or determining different upper boundary constraints for Type 1 versus Type 2 patients”, examiner acknowledges that Mazlish does not explicitly disclose administration parameters include an indication of diabetes type but the examiner already relied on Gass to meet that limitation in the Office Action as Gass discloses a system to indicate/input an indication of Type 1 diabetes and Type 2 diabetes (para. [0029]-[003 1] of Gass).
With regard to the arguments that “Mazlish does not teach automatically ascertaining or calculating an upper boundary constraint based on diabetes type and glucose control metric. The target amount of medicine in Mazlish is a manually- set parameter applicable to any patient, not a diabetes-type-specific upper boundary constraint that is ascertained based on glucose control metrics. Additionally, Mazlish’ s administration parameters are static values or ranges uploaded during system setup (Mazlish, col. 10, lines 49-62) and thus Mazlish cannot ascertain upper boundary constraints in response to the indication of diabetes type and based on glucose control metrics as the administration parameters are statically set”, examiner respectfully disagrees. The administration parameters influence the controller to specify (determine) a target amount of medicine to deliver; a frequency of delivery; and/or conditions, constraints, or algorithms for deviating a medicine administration from the target amount of medicine. Thus when an user manually sets an input that indicates the user has type 2 diabetes, the controller specifies a target amount of medicine to deliver or constraints, or algorithms for deviating a medicine administration from the target amount of medicine. Or in other words the system ascertain an upper boundary constraint for a medicine amount for the type of diabetes indicated.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Thus, the rejections of claims 1-16 are maintained.
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 1-5, 8-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US 2020/0390973); in view of Doyle (US 2014/0200559), Gass (US 2018/0130551), and Mulish (US 10987468).
Regarding Claim 1, Wu discloses a wearable drug delivery device (fluid infusion device/infusion pump (102; Fig. l), comprising: a controller (control system (200); Fig. 2); a container containing a liquid drug (para [0023]); a pump mechanism (plunger (2 17) and motor (232)) coupled to the controller (200), wherein the pump mechanism is configured to expel the liquid drug from the container in response to control signals (command signals) from the controller (para [0035]); and a memory (memory within motor control module (212)) (In exemplary embodiments, the motor control module 212 includes or otherwise accesses a data storage element or memory, including any sort of random access memory (RAM), read only memory (ROM), flash memory, registers, hard disks, removable disks, magnetic or optical mass storage, or any other short or long term storage media or other non-transitory computer-readable medium, which is capable of storing programming instructions for execution by the motor control module 212; para [0038], lines 9-17) storing an automatic drug delivery algorithm (programming instructions) (para [0038]), the automatic drug delivery algorithm when executed by the controller, configures the controller to receive a glucose control metric (current glucose measurement value) (para [0047]); generate a control signal based on the determined amount of the dose of the liquid drug (para [0047]); and apply the control signal (output (430)) to the pump mechanism to expel the amount of the dose of the liquid drug from the container (para [0047], last sentence).
Wu does not appear to disclose receive an indication of a type of diabetes that will be controlled by the controller, wherein the controller is configured to receive an indication of Type 1 diabetes and wherein the controller is configured to receive an indication of Type 2 diabetes.
Wu does not further disclose ascertain, in response to the indication of the type of diabetes being Type 1 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug of Type 1 diabetes mellitus, wherein the upper boundary constraint is a fixed clinical multiple of a total daily dosage setting for the liquid drug; determine an amount of a dose of the liquid drug to be delivered based on the upper boundary constraint for the Type 1 diabetes mellitus. Ascertain, in response to the indication of the type of diabetes being Type 2 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug for Type 2 diabetes mellitus.
Gass teaches it was known in the art to indicate/input an indication of Type l diabetes and Type 2 diabetes (para [0029]-[0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Gass to have a controller that is configured to receive an indication of Type 1 diabetes and an indication of Type 2 diabetes in order to calculate the correction factor (para [0032]).
Doyle teaches it was known in the art to indicate the type of diabetes is Type 1 diabetes mellitus (TIDM) (para [0024], first sentence), an upper bound constraint (0) of insulin (para [0119]) and amount of glucose (Table S2) wherein the upper bound constraint (0) is a fixed clinical [fixed range between clinical trials] (para 0127-28) multiple of the insulin infusion rate to determine amount of insulin (equation 5, para 0136-38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Doyle to have an indication of a type of diabetes (Type 1 diabetes mellitus or Type 2 diabetes mellitus) that will be controlled by the controller, an upper boundary constraint for the liquid drug of Type 1 diabetes mellitus, wherein the upper boundary constraint is a fixed clinical multiple of a total daily dosage setting for the liquid drug, and determine an amount of a dose of the liquid drug to be delivered in order to prevent over delivering of insulin (para [0119]).
Mazlish teaches it was known in the art to ascertain/determine, in response to the indication of the type of diabetes being Type 2 mellitus (Multi-modal medicine delivery systems and methods provided herein may be used and performed, respectively, by a user, for example, a type 1 or 2 diabetes patient or a caregiver of a diabetes patient; column 7, lines 45-48), and glucose control metric via analyte sensor (3) (One example of such a system 2 includes the computing device 5 receiving a glucose reading from the analyte sensor 3 and communicating with the DDS 4 to determine, recommend, and/or deliver one or more doses of insulin, glucagon, or other medicine; column 8, lines 44-49), an upper boundary constraint (target amount of medicine) for the liquid drug (For example, the administration parameters may influence the operation of the DDS 4 and/or analyte sensor 3 by specifying a target amount of medicine to deliver; a frequency of delivery; and/or conditions, constraints, or algorithms for deviating a medicine administration from the target amount of medicine based on inputs from an analyte sensor 3 or based on user notification (e.g., input indicative of exercise or of a meal); column 10, lines 49-56).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Mazlish to ascertain, in response to the indication of the type of diabetes being Type 2 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug for Type 2 diabetes mellitus in order to monitor glucose levels based on the specified/determined target amount of medicine (column 8, lines 44-49 and column 10, lines 49-56).
Regarding Claim 2, Wu as modified discloses the wearable drug delivery device of claim 1, and Doyle further teaches wherein the controller is further configured by execution of the automatic drug delivery algorithm to: receive an indication of a comorbidity (hypoglycemic) of a user (para [0115]); and adjust (parameters in table S2 are adjustable, The adjustable parameters used in the PZNIPC algorithm are listed in Table S2. These parameters are adjustable in the sense that they may be adjusted, within the ranges listed in Table S2, between clinical trials; para [0175], lines 1-4), based on the indication of the comorbidity, the upper boundary constraint (target glucose value) for the liquid drug (para 0127-28); and use the adjusted upper boundary constraint to determine the amount of the dose of the liquid drug to be delivered based on the upper boundary constraint (para. [0119]).
Regarding Claim 3, Wu as modified discloses the wearable drug delivery device of claim l, and Doyle further teaches wherein the controller is further configured by execution of the automatic drug delivery algorithm to: based on the indication of the type of diabetes (para [0024], first sentence), evaluate the glucose control metric to determine a setting for the multiple of the total daily dosage setting (para 0127-28 and 0136-38). Wu discloses store the glucose control metric (the current glucose level is viewed on a computer (108) that has a memory, para [0024], lines 12-18), the determined multiple and the upper boundary constraint in the memory (para [0047], second sentence: the upper boundary constraint modified from Doyle is fully capable of being saved on the memory of Wu).
Regarding Claim 4, Wu as modified discloses the wearable drug delivery device of claim 1, and Wu further discloses store the glucose control metric, the fixed clinical multiple setting and the upper boundary constraint in the memory (para [0047] second sentence: the upper boundary constraint modified from Doyle is fully capable of being saved on the memory of Wu).
Regarding Claim 5, Wu as modified discloses the wearable drug delivery device of claim 1, Doyle further teaches wherein the controller is further configured by execution of the automatic drug delivery algorithm to: in response to the indication of the type of diabetes being for Type 1 diabetes mellitus (para [0024]), evaluate the glucose control metric to determine a multiple (fixed range between clinical trials, para 0127-28 of the total daily dosage setting (equation 5, para [0136]-[0138]).
Wu discloses store the glucose control metric (the current glucose level is viewed on a computer (108) that has a memory, para [0024], lines 12-18), the determined multiple and the upper boundary constraint in the memory (para [0047], the upper boundary constraint modified from Doyle is fully capable of being saved on the memory of Wu).
Regarding Claim 8, Wu as modified discloses the wearable drug delivery device of claim 1, and further discloses comprising: a communication interface (user interface (240)) coupled to the controller (Figs2), the communication interface including circuitry configured to: respond to wireless signals or haptic inputs, receive the glucose control metric via a wireless signal or a haptic input (the target glucose value utilized by the pump control system (220) may be input by a patient via user interface (240) wherein the user interface (240) includes a haptic feedback device, para [0034]), and forward the glucose control metric to the controller (the pump control system (220) within the control system (200) receives the target glucose value via the user interface (240) see para [0034]).
Regarding Claim 9, Wu discloses a non-transitory computer readable medium embodied with programming code that causes a processor when executing the programming code to: obtain a glucose control metric (current glucose measurement value, see para [0047]); generate a control signal based on the determined amount of the dose of the liquid drug (para [0047]); and apply the control signal (output (430)) to a pump mechanism ((plunger (217) and motor (232)) to expel the dose of the liquid drug from a container (para [0047], last sentence).
Wu does not appear to disclose the processor when executing the programming code is configured to receive an indication of Type 1 diabetes and wherein the processor when executing the programming code is configured to receive an indication of Type 2 diabetes. Wu does not further disclose ascertain, in response to the indication of the type of diabetes being Type 1 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug of Type 1 diabetes mellitus, wherein the upper boundary constraint is a fixed clinical multiple of a total daily dosage setting for the liquid drug; determine an amount of a dose of the liquid drug to be delivered based on the upper boundary constraint for the Type 1 diabetes mellitus. Wu does not disclose ascertain, in response to the indication of the type of diabetes being Type 2 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug for Type 2 diabetes mellitus.
Gass teaches it was known in the art to indicate/input an indication of Type 1 diabetes and Type 2 diabetes (para [0029]-[0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Gass to have a controller that is configured to receive an indication of Type 1 diabetes and an indication of Type 2 diabetes in order to calculate the correction factor (para [0032]).
Doyle teaches it was known in the art to indicate the type of diabetes is Type I diabetes mellitus (TIDM) (para [0024], first sentence), an upper bound constraint (0) of insulin (para [0119]) and amount of glucose (Table S2) wherein the upper bound constraint is a fixed clinical (fixed range between clinical trials, para 0136-38) multiple of the insulin infusion rate to determine amount of insulin (equation 5, para [0136]-[0138]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Doyle to have an indication of a type of diabetes (Type 1 diabetes mellitus or Type 1 diabetes mellitus) that will be controlled by the controller, an upper boundary constraint for the liquid drug of Type 1 diabetes mellitus, wherein the upper boundary constraint is a fixed clinical multiple of a total daily dosage setting for the liquid drug, and determine an amount of a dose of the liquid drug to be delivered in order to prevent over delivering of insulin (para [0119]).
Mazlish teaches it was known in the art to ascertain/determine, in response to the indication of the type of diabetes being Type 2 mellitus (Multi-modal medicine delivery systems and methods provided herein may be used and performed, respectively, by a user, for example, a type 1 or 2 diabetes patient or a caregiver of a diabetes patient; column 7, lines 45-48), and glucose control metric via analyte sensor (3) (One example of such a system 2 includes the computing device 5 receiving a glucose reading from the analyte sensor 3 and communicating with the DDS 4 to determine, recommend, and/or deliver one or more doses of insulin, glucagon, or other medicine; column 8, lines 44-49), an upper boundary constraint (target amount of medicine) for the liquid drug (For example, the administration parameters may influence the operation of the DDS 4 and/or analyte sensor 3 by specifying a target amount of medicine to deliver; a frequency of delivery; and/or conditions, constraints, or algorithms for deviating a medicine administration from the target amount of medicine based on inputs from an analyte sensor 3 or based on user notification (e.g., input indicative of exercise or of a meal); column 10, lines 49-56).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Mazlish to ascertain, in response to the indication of the type of diabetes being Type 2 diabetes mellitus, and the glucose control metric, an upper boundary constraint for the liquid drug for Type 2 diabetes mellitus in order to monitor glucose levels based on the specified/determined target amount of medicine (column 8, lines 44-49 and column 10, lines 49-56).
Regarding Claim 10, Wu as modified discloses the non-transitory computer readable medium of claim 9, and Doyle further teaches wherein the programming code further causes the processor when executing the programming code to: receive an indication of a comorbidity (hypoglycemic) of a user (para [0115]); and adjust (parameters in table S2 are adjustable, The adjustable parameters used in the PZMPC algorithm are listed in Table S2. These parameters are adjustable in the sense that they may be adjusted, within the ranges listed in Table S2, between clinical trials; see para. [0175], lines 1-4), based on the indication of the comorbidity, the upper boundary constraint (target glucose value) for the liquid drug (para [0127]-[0128]); and use the adjusted upper boundary constraint to determine the amount of the dose of the liquid drug to be delivered based on the upper boundary constraint (para [01 19]).
Regarding Claim 11 , Wu as modified discloses the non-transitory computer readable medium of claim 9, and Doyle further teaches wherein the programming code further causes the processor when executing the programming code to: based on the indication of the type of diabetes (para [0024], first sentence), evaluate the glucose control metric to determine a setting for a multiple of the total daily dosage setting (para [0127-28], equation 5, para [0136-38]). Wu discloses store the glucose control metric (the current glucose level is viewed on a computer (108) that has a memory, see para [0024], lines 12-18), the determined multiple and the upper boundary constraint in the memory (para [0047], second sentence, the upper boundary constraint modified from Doyle is fully capable of being saved on the memory of Wu).
Regarding Claim 12, Wu as modified discloses the non-transitory computer readable medium of claim 9, Wu further discloses store the glucose control metric, the fixed clinical multiple setting and the upper boundary constraint in the memory (para [0047], second sentence, and the upper boundary constraint modified from Doyle is fully capable of being saved on the memory of Wu).
Regarding Claim 13, Wu as modified discloses the non-transitory computer readable medium of claim 9, Doyle further teaches wherein the programming code further causes the processor when executing the programming code to: in response to the indication of the type of diabetes being for Type 1 diabetes mellitus (para [0024], first sentence), evaluate the glucose control metric amount of glucose (Table S2) to determine a multiple (fixed range between clinical trials, see para [0127]-[0128]) of the total daily dosage setting (equation 5, para [0136-38]). Wu discloses store the glucose control metric (the current glucose level is viewed on a computer (108) that has a memory, para [0024], lines 12-18), the determined multiple and the upper boundary constraint in the memory (para [0047], second sentence and the upper boundary constraint modified from Doyle is fully capable of being saved on the memory of Wu).
Regarding Claim 16, Wu as modified discloses the non-transitory computer readable medium of claim 9, and further discloses wherein the programming code further causes the processor when executing the programming code to: receive the glucose control metric via a wireless signal or a haptic input (the target glucose value utilized by the pump control system (220) may be input by a patient via user interface (240) wherein the user interface (240) includes a haptic feedback device, para [0034]), and forward the glucose control metric to the controller (the pump control system (220) within the control system (200) receives the target glucose value via the user interface (240), para[0034]).
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US 2020/0390973); in view of Doyle (US 2014/0200559), Gass (US2018/0130551), and Mulish (US 10987468) and Bitton (WO 2006097933 A2).
Regarding Claim 7, Wu as modified discloses all the limitations of claim 1 above.
Wu does not appear to disclose a glucose control metric is a percentage of red blood cells that have sugar-coated hemoglobin over a period of time.
Bitton teaches it was known in the art to have a glucometer (20; Fig. 1) that determines blood glucose and concentration of a marker (hemoglobin (Hb)), page 9, lines 23-26). Changes in hemoglobin (Hb)/red blood cells count over time are correlated with the changes in glucose concentration (page 3, lines 9-19). Therefore, the glucose concentration is percentage of hemoglobin (changes of hemoglobin over time) over a period of time.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Bitton to have a glucose control metric is a percentage of red blood cells that have sugar-coated hemoglobin over a period of time in order to determine concentration of glucose (page 3, lines 9-19).
Regarding Claim 15, Wu as modified discloses all the limitations of claim 9 above.
Bitton teaches it was known in the art to have a glucometer (20; Fig. 1) that determines blood glucose and concentration of a marker (hemoglobin (Hb)), page 9, lines 23-26). Changes in hemoglobin (Hb)/red blood cells count over time are correlated with the changes in glucose concentration (page 3, lines 9-19). Therefore, the glucose concentration is percentage of hemoglobin (changes of hemoglobin over time) over a period of time.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Bitton to have a glucose control metric is a percentage of red blood cells that have sugar-coated hemoglobin over a period of time in order to determine concentration of glucose (page 3, lines 9-19).
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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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783
/JASON E FLICK/ Primary Examiner, Art Unit 3783 08/20/2026
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