DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Amendment Entered
This Office action is responsive to the Amendment filed on May 5th, 2026. The examiner acknowledges the amendments to claims 1, 9, 12, and 14, as well as the cancellation of claims 4, 13, and 15-25. Claim 26 has been added. Claims 1-3, 5-12, 14, and 26 remain pending in the application.
Response to Arguments
Applicant’s arguments, filed May 5th, 2026, with respect to the claim objections have been fully considered but are not persuasive. On page 5 of the response filed 9/16/24, Applicant argues that there is no legal, regulatory or guiding authority that supports requiring that a claim start with “A” or “The”. Examiner respectfully disagrees. MPEP 608.01(n) IV recites:
IV. CLAIM FORM AND ARRANGEMENT
A singular dependent claim 2 could read as follows:
2. The product of claim 1 in which ...
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
Therefore, the claim objections are maintained.
Applicant's arguments filed May 5th, 2026 with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At page 5, Applicant argues that the claims are patent eligible because the step of configuring the medication delivery is not an abstract idea. Examiner respectfully disagrees. "The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s) must have more than a nominal or insignificant relationship to the exception(s)." See MPEP 2106.04(d)(2). The claims do not explicitly recite any steps as to how the medication delivery is being configured and the type or amount/dosage of medication that is being configured/delivered, rather the claim recites “configuring the medication delivery based on the sensitivity”. The medication being delivered could be any kind of medication. Furthermore, it seems as if the treatment or prophylaxis limitation has a nominal or insignificant relationship to the exceptions as it is unclear how the medication delivery is being configured/adjusted, what type and amount/dosage of medication are being administered as treatment, and what condition the administration of fluid is working to prevent, reduce, or treat. The step of configuring the delivery based on the sensitivity is merely referring to the relevant pre-existing audience of doctors who used medication to treat patients. The step of configuring and delivering a medication was known to doctors, and was well-known, routinely, and conventionally used to treat patients – as evidenced by the non-patent literature of record. A clinician knowledgeable in treating patients would have known and be capable to configure and deliver the well-known, routine, and conventionally used medications. Therefore, the step of “configuring the delivery based on the sensitivity” is merely an instruction to “apply” the delivery using well-understood, routine, or conventional techniques in the field. Examiner suggests amending the claim to further specify how the medication delivery is configured/adjusted, the type and amount/dosage of medication being delivered, and the condition that is prevented, reduced, or treated, such that the treatment or prophylaxis limitation has more than a nominal or insignificant relationship to the exception. Examiner also suggests reciting that the step of configuring the medication delivery is performed by a controller that controls a pump to adjust a pumping algorithm (see para. [0015, 0063-0064, 0093, 0134] of the specification).
Applicant's arguments filed May 5th, 2026 with respect to the rejections under 35 U.S.C. 103 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
Claims 1-3, 5-14, and 26 are objected to because of the following informalities:
Claims 1, 14, and 26 should begin with “A” and claims 2-3, 5-12 should begin with “The”.
“by a patient” in claim 1 line 2 should recite “of a patient”.
“non-transient” in claim 26 line 1 should recite “non-transitory”.
Appropriate correction is required.
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 1-3, 5-12, 14, and 26 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.
Claim 1 (claims 2-3, 5-12, 14, and 26 by virtue of dependency) recites the limitation “defining a sensitivity” in lines 7-8. It is unclear if this is in addition to or the same determined sensitivity recited in line 2. The limitation is suggested to recite “defining the sensitivity”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites “wherein said perturbing and said recovering are based on one or more of: single- tone perturbation; frequency key shifting; code division multiplexing; and heterodyning” which are principles of signal processing. The “principles of signal processing” recited in claim 3 is broader than the specific signal processing principles (single- tone perturbation; frequency key shifting; code division multiplexing; and heterodyning) recited in claim 1 and do not further limit the signal processing principles of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5-12, 14, and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claims 1, the claims recite a series of steps or acts. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
Determining a sensitivity by a patient to a medication delivered in a delivery amount at a delivery frequency
Recovering an effect of the perturbation from the patient response
Defining a sensitivity
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
Claim 1 recites perturbing the delivery amount by a perturbation amount at a perturbation frequency and measuring a patient response to said perturbing, wherein said perturbing and said recovering are based on one or more of: single- tone perturbation; frequency key shifting; code division multiplexing, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The perturbing and measuring steps do not provide an improvement to the technological field, the method/steps does not effect a particular treatment or effect a particular change based on the defined sensitivity, nor does the method use a particular machine to perform the Abstract Idea.
The step of configuring the delivery based on the sensitivity is merely an instruction to “apply” the delivery using well-understood, routine, or conventional techniques in the field. "The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s) must have more than a nominal or insignificant relationship to the exception(s)." See MPEP 2106.04(d)(2). The claims do not explicitly recite any steps as to how the medication delivery is being configured and the type or amount/dosage of medication that is being delivered/configured, rather the claim recites “configuring the medication delivery based on the sensitivity”. The medication being configured and delivered could be any kind of medication. Furthermore, it seems as if the treatment or prophylaxis limitation has a nominal or insignificant relationship to the exceptions as it is unclear how the medication delivery is being configured/adjusted, what type and amount/dosage of medication are being administered as treatment, what condition the administration of fluid is working to prevent, reduce, or treat. The step of configuring the delivery based on the sensitivity is merely referring to the relevant pre-existing audience of doctors who used medication to treat patients. The step of configuring and delivering a medication was known to doctors, and was well-known, routinely, and conventionally used to treat patients – as evidenced by the non-patent literature of record. A clinician knowledgeable in treating patients would have known and be capable to configure and deliver the well-known, routine, and conventionally used medications based on a sensitivity.
Regarding claims 26 and 14, the system recited in the claim is a generic system comprising a processor configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
perturbing the deliver amount by a perturbation amount at a perturbation frequency, wherein said perturbing and said recovering are based on one or more of: single- tone perturbation; frequency key shifting; code division multiplexing;
measure a patient response to said perturbing;
configuring the delivery based on the sensitivity
The perturbing and measuring steps are well-understood, routine and conventional activities for those in the field of medical diagnostics – as evidenced by the non-patent literature of record. Further, the perturbing and measuring steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The step of configuring the delivery based on the sensitivity is merely an instruction to “apply” the delivery using well-understood, routine, or conventional techniques in the field. "The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s) must have more than a nominal or insignificant relationship to the exception(s)." See MPEP 2106.04(d)(2). The claims do not explicitly recite any steps as to how the medication delivery is being configured and the type or amount/dosage of medication that is being configured/delivered, rather the claim recites “configuring the medication delivery based on the sensitivity”. The medication being delivered could be any kind of medication. Furthermore, it seems as if the treatment or prophylaxis limitation has a nominal or insignificant relationship to the exceptions as it is unclear how the medication delivery is being configured/adjusted, what type and amount/dosage of medication are being administered as treatment, what condition the administration of fluid is working to prevent, reduce, or treat. The step of configuring the delivery based on the sensitivity is merely referring to the relevant pre-existing audience of doctors who used medication to treat patients. The step of configuring and delivering a medication was known to doctors, and was well-known, routinely, and conventionally used to treat patients – as evidenced by the non-patent literature of record. A clinician knowledgeable in treating patients would have known and be capable to configure and deliver the well-known, routine, and conventionally used medications based on a sensitivity.
Regarding claims 26 and 14, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by: Applicant’s specification (e.g., para. [0054]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g., recovering, defining) that are well-understood, routine, and conventional activities previously known to the pertinent industry and The Non-Patent Literature of record.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-3, 5-12 and 26 are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-6, 9-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rantala (US 20070208322 A1 - previously cited) in view of Anquetil (US 20080125977 A1).
Regarding claim 1, Rantala discloses a method of customizing a medication delivery (Abstract, para. [0041, 0045-0046]) comprising: determining sensitivity by a patient to a medication delivered in a delivery amount at a delivery frequency (method for calibrating the sensitivity; “delivery rate”; “amount … dose”, Abstract, para. [0035, 0037, 0039, 0044], figs. 1-2), said method comprising: perturbing the delivery amount by a perturbation amount (“changes in the amount of drug or its infusion rate … initiated automatically”; “1 mg”, para. [0035, 0038-0039, 0044], fig. 2) at a perturbation frequency (unlabeled, but at seen by peaks 9 & 11 in fig. 2, “calibration … initiated … regular intervals or … randomly chosen moments”, para. [0039-0040, 0045]); measuring a patient response to said perturbing (response/entropy signal 8, fig. 2, para. [0037-0039, 0044]); and recovering an effect of said perturbing from the patient response (change 10, 12 & delay 13 in the response/entropy signal 8 detected, fig. 2, “detecting unit … change in entropy”, para. [0038-0039, 0044]) and defining a sensitivity (“sensitivity … calculated as the ratio between the change in the measured signal and the infusion rate change”, para. [0038-0039, 0044]); and configuring the delivery based on the sensitivity (“control unit 17 … feedback loop … required infusion rate change is calculated using … sensitivity parameter … bolus and infusion rate change”, para. [0041, 0045-0046]). Rantala further discloses that the frug may be any other drug such drug that causes a measurable change in the patient's body and the signal responsive to the drug may be any such signal that changes in response to the given drug (para. [0047]).
Rantala does not disclose wherein said perturbing and said recovering are based on one or more of: single-tone perturbation; frequency key shifting; code division multiplexing; and heterodyning.
However, Anquetil directed to methods of manipulating the quantum states of a molecule or collection of molecules, informed by the detected response to a perturbation (para. [0009-0010]) discloses perturbing a delivery amount at a delivery frequency (“perturb the system in order to explore and understand the response of the system”; “frequency ... amplitude”; “external perturbations 310 are applied to a target sample 320”, para. [0012, 0022, 0029, 0033-0038], fig. 3) and recovering an effect of said perturbing (“perturb the system in order to explore and understand the response of the system”; “detector may monitor the observed signal to look for the pattern expected in response to the input”; “responses of target sample 320 are measured by detector 330”, para. [0012, 0022, 0033-0038], fig. 3), wherein said perturbing and said recovering are based on one or more of: single-tone perturbation; frequency key shifting; code division multiplexing; and heterodyning (“perturbation ... heterodyne detection ... target molecule evolves according to a prescribed pattern or code ... enhance detection efficiency”, para. [0033]). Anquetil further discloses that many modifications and changes may be made to it without departing from the spirit and scope of the invention (para. [0042] (see also para. [0013, 0025-0026])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rantala such that said perturbing and said recovering are based on one or more of: single-tone perturbation; frequency key shifting; code division multiplexing; and heterodyning, in view of the teachings of Anquetil, as this would aid in enhancing detection efficiency and would aid in understanding the response of the system by empirically determining the system function by mapping the effects of different input (drug infusion rate change) sequences to the corresponding responses of the system (Anquetil, para. [0033-0038]).
Regarding claim 2, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 wherein the delivery amount and/or delivery frequency depends on the sensitivity (infusion rate change can be done automatically … required infusion rate change is calculated using the most recent sensitivity parameter … desired level, para. [0041, 0045-0046]).
Regarding claim 3, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 wherein said perturbing and said recovering are configured according to principles of signal processing (“data processing device”; “filtered values”; “signal processing”, para. [0017, 0039, 0043]).
Regarding claim 5, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 wherein the perturbation frequency (peaks 9 & 11, as seen in fig. 2, “calibration bolus 1 mg … regular intervals or randomly chosen moments”, para. [0002, 0039, 0044-0045]) is less than the delivery frequency (“steady infusion”; “infusion rate of a drug 7”, para. [0002, 0037, 0039, 0044-0045]) (as seen in fig. 2).
Regarding claim 6, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 wherein said measuring has a measuring frequency (peaks 10 & 12, as seen in fig. 2, “steady infusion”; “change (e.g. 10, 12) in the response signal … detected”; “detects … change in entropy signal … caused by the change in the infusion rate”, para. [0002, 0039, 0044-0045]) that is less than the delivery frequency (“steady infusion”; “infusion rate of a drug 7”, para. [0002, 0037, 0039, 0044-0045]) (as seen in fig. 2).
Regarding claim 9, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 further comprising varying the perturbation frequency (“randomly chosen moments”; “periodically, irregularly or at regular intervals”, para. [0040, 0045], fig. 2).
Regarding claim 10, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 wherein the perturbation frequency is selected to enable determination of a correspondence with the sensitivity (“infusion rate … added momentarily ...sensitivity of the patient to the drug at that moment determined”; “irregularly or at regular intervals”, para. [0015, 0039, 0045], fig. 2).
Regarding claim 11, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1 wherein the perturbation amount is variable (“calibration bolus of 1 mg”; “additional boluses … or reduce the infusion rate”, para. [0035, 0039, 0044], peaks 9 & 11, fig. 2).
Regarding claim 12, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 9 further comprising varying the perturbation amount (“change can also be negative ... momentarily reduced”; “calibration bolus of 1 mg”; “additional boluses … or reduce the infusion rate”, para. [0015, 0035, 0039, 0044], peaks 9 & 11, fig. 2).
Regarding claim 14, Rantala, as modified by Anquetil hereinabove, discloses a system for customizing a medication delivery (Abstract, para. [0041, 0045-0046]) comprising a processor (17 & 20, fig. 3, “data processing device”; “signal processing ... detecting unit”, para. [0017, 0043-0044]) configured for the method of claim 1 (see claim 1 above).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rantala in view of Bendriem (US 8058620 B2 – previously cited).
Regarding claim 7, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1. Rantala, as modified by Anquetil hereinabove, does not disclose wherein the perturbation frequency maximizes a signal to noise ratio of the sensitivity.
However, Bendriem directed to a method for improving the quality of clinical data in PET in order to optimize the patient dose of radiopharmaceutical discloses wherein the perturbation frequency maximizes a signal to noise ratio of the sensitivity (“maximum SNR that could have been realized for any dose or uptake … optimal dose is defined as the dose … achieved peak SNR … differential dose benefit … incremental increase in SNR per unit incremental increase in dose”, col. 2 lines 47-53 & col. 5 lines 17-48 & col. 12 line 17 – col. 13 line 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 Rantala, as modified by Anquetil hereinabove, such that the perturbation frequency maximizes a signal to noise ratio of the sensitivity, in view of the teachings of Bendriem, as this would aid in providing an optimal dose and optimizing subsequent sensitivity calibration.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rantala in view of Anquetil, as applied to claim 1 above, and further in view of Selander (US 20210267506 A1 – previously cited).
Regarding claim 8, Rantala, as modified by Anquetil hereinabove, discloses the method of claim 1. Rantala, as modified by Anquetil hereinabove, does not disclose wherein said recovering comprises demodulating the patient response.
However, Selander directed to techniques for data analysis and user guidance and an ecosystem 100 for collection and analysis of data that comprises a sensor 110 including one or more wires or electrodes coupled to the body and computing device 800/115 that is configured to interface with an insulin pump to automatically determine and administer appropriate amounts of insulin (figs. 1 & 8, para. [0033, 0116, 0194]) discloses wherein said recovering comprises demodulating the patient response (“demodulates the received signal to extract data”, para. [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rantala, as modified by Anquetil hereinabove, such that said recovering comprises demodulating the patient response, in view of the teachings of Selander, as this would aid in extracting data from the received signals.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rantala in view of Anquetil, as applied to claim 1 above, and further in view of Breton (US 20170056591 A1).
Regarding claim 26, Rantala, as modified by Anquetil hereinabove discloses instructions configured for the method of claim 1 (“computer program comprising code ... executed on a data processing device”, para. [0017], control unit 17, fig. 3).
Rantala, as modified by Anquetil hereinabove does not disclose a non-transient, computer-readable medium configured for storing instructions.
However, Breton directed to system, method, and computer readable medium for dispensing insulin to a patient that recognizes patient insulin sensitivity varies over time discloses a non-transient, computer-readable medium configured for storing instructions configured for a method (“process ... executed by controller ... receives the instructions ... controller may access the program from non-transitory computer readable media”, para. [0135, 0002])b.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rantala to comprise a non-transient, computer-readable medium configured for storing instructions, in view of the teachings of Breton, as this would aid the controller/data processing device in accessing the instructions/computer program to be executed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tran (US 10998101 B1) directed to health management with sensors and a method that adjusts boluses pre-meal and at least 4 hours post-meal in 0.5 unit increments based upon the trend arrow and the patient's sensitivity (col. 13 line 60 – col. 24 line 23);
Modell (US 5022757 A) directed to a system and method for sensing a target substance in a medium and discloses that the system and method may also be used for therapy such as by controlling drug dosage before, during or after surgery and/or treatment using photodynamic sensitizers or other compounds which can be optically imaged (col. 10 lines 22-39);
R. D. Keyser, D. Copot and C. Ionescu, "Estimation of Patient Sensitivity to Drug Effect during Propofol Hypnosis," 2015 IEEE International Conference on Systems, Man, and Cybernetics, Hong Kong, China, 2015, pp. 2487-2491, doi: 10.1109/SMC.2015.435;
E.D. Lehmann and T. Deutsch 1992 J. Biomed. Eng. 14 243 DOI 10.1016/0141-5425(92)90059-T directed to insulin dosage adjustment in diabetes;
Uyttendaele et al., A 3D insulin sensitivity prediction model enables more patient-specific prediction and model-based glycaemic control, Biomedical Signal Processing and Control, Volume 46,Pages 192-200, ISSN 1746-8094, https://doi.org/10.1016/j.bspc.2018.05.032.
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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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