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 .
Claim Objections
Claims 1-25 are objected to because of the following informalities:
Claims 1, 13, and 14 should begin with “A” and claims 2-12 & 15-25 should begin with “The”.
Appropriate correction is required.
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 1-25 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 claims 1 and 14 follows.
STEP 1
Regarding claims 1 and 14, the claims recite a series of structural elements, including a system, and series of steps or acts. Thus, the claims are directed to a process (claim 1) and a machine (claim 14), 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:
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.
Claims 1 and 14 recite perturbing the delivery amount by a perturbation amount at a perturbation frequency and measuring a patient response to said perturbing, 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.
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:
a processor in communication with a pump and a sensor;
the pump is responsive to the sensor;
the sensor is configured to transmit a signal ...;
perturbing the deliver amount by a perturbation amount at a perturbation frequency;
measure a patient response to said perturbing.
The perturbing and measuring steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. 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.
Regarding claim 14, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited processor in communication with recited pump and sensor are generic pumps and sensors configured to perform pre-solutional data gathering activity, and the 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.
The Non-Patent Literature of record;
Berián, J., Bravo, I., Gardel, A., Lázaro, J. L., & Hernández, S. (2019). A Wearable Closed-Loop Insulin Delivery System Based on Low-Power SoCs. Electronics, 8(6), 612. https://doi.org/10.3390/electronics8060612;
M. J. Khodaei, N. Candelino, A. Mehrvarz and N. Jalili, "Physiological Closed-Loop Control (PCLC) Systems: Review of a Modern Frontier in Automation," in IEEE Access, vol. 8, pp. 23965-24005, 2020, doi: 10.1109/ACCESS.2020.2968440
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-12 and 15-25 merely recite 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 § 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.
Claims 1-3, 5-6, 9-16, 18-19, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rantala (US 20070208322 A1).
Regarding claim 1, Rantala discloses a method of 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]).
Regarding claim 2, Rantala 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 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 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 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 discloses the method of claim 1 wherein the perturbation frequency is variable (“randomly chosen moments”; “periodically, irregularly or at regular intervals”, para. [0040, 0045], fig. 2).
Regarding claim 10, Rantala 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 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 discloses the method of claim 9 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 13, Rantala discloses a method of customizing a medication delivery according to claim 1 (see claim 1 above, Rantala, Abstract, para. [0045-0046]) comprising controlling the delivery amount and/or the delivery frequency based on the sensitivity (“control unit 17 … feedback loop … required infusion rate change is calculated using … sensitivity parameter … bolus and infusion rate change”, para. [0045-0046]).
Regarding claim 14, Rantala discloses a system for determining sensitivity by a patient to a medication delivered in a delivery amount at a delivery frequency (system for calibrating the sensitivity; “delivery rate”; “amount … dose”, Abstract, para. [0035, 0037, 0039, 0044], figs. 1-3), said system comprising: a processor (17 & 20, fig. 3, “data processing device”; “detecting unit”, para. [0017, 0044]) configured to be in communication (as seen in fig. 3, para. [0042-0043]) with a pump (“motor driven infusion pump”, para. [0042], 18, fig. 3) and a sensor (“unit 20 … electrodes on the forehead of the patient 19”, para. [0043], fig. 3); wherein: the pump is responsive to said processor (“controlled”, para. [0044]); the sensor is configured to transmit a signal that corresponds to a physiological parameter (“entropy signal … provided as input”, para. [0043]); said processor (control unit 17, fig. 3, “data processing device”, para. [0017]) is configured to: perturb 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]); measure a patient response to said perturbing (response/entropy signal 8, fig. 2, para. [0037-0039, 0044]); and recover an effect of the perturbation from the patient response (change 10, 12 & delay 13 in the response/entropy signal 8 detected, fig. 2, “detecting unit …. Change in the entropy signal”, para. [0038-0039, 0044]) and define a sensitivity (“sensitivity … calculated as the ratio between the change in the measured signal and the infusion rate change”, para. [0038-0039, 0044]).
Regarding claim 15, Rantala discloses the system of claim 14 wherein said processor (17 & 20, fig. 3) is configured to adjust the delivery amount and/or delivery frequency based 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 16, Rantala discloses the system of claim 14 wherein said processor (17 & 20, fig. 3) is configured to perturb the delivery amount and recover the effect of the perturbation according to principles of signal processing (“data processing device”; “filtered values”; “signal processing”, para. [0017, 0039, 0043]).
Regarding claim 18, Rantala discloses the system of claim 14 wherein said processor (17 & 20, fig. 3) is configured to maintain 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]) at 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 19, Rantala discloses the system of claim 14 wherein said processor (17 & 20, fig. 3) is configured to measure at a measuring frequency (peaks 9 & 11, as seen in fig. 2, “calibration bolus 1 mg … regular intervals or randomly chosen moments”, 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 22, Rantala discloses the system of claim 14 wherein said processor (17 & 20, fig. 3) is configured to vary the perturbation frequency (“randomly chosen moments”; “periodically, irregularly or at regular intervals”, para. [0040, 0045], fig. 2).
Regarding claim 23, Rantala discloses the system of claim 14 wherein said processor is configured to maintain the perturbation frequency so as 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 24, Rantala discloses the system of claim 14 wherein said processor (17 & 20, fig. 3) is configured to vary the perturbation amount (“calibration bolus of 1 mg”; “additional boluses … or reduce the infusion rate”, para. [0035, 0039, 0044], peaks 9 & 11, fig. 2).
Regarding claim 25, Rantala discloses the system of claim 22 wherein said processor (17 & 20, fig. 3) is configured to vary the perturbation amount (“calibration bolus of 1 mg”; “additional boluses … or reduce the infusion rate”, para. [0035, 0039, 0044], peaks 9 & 11, fig. 2).
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.
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 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rantala in view of Robertson (US 8540664 B2).
Regarding claim 4, Rantala discloses the method of claim 1 and that it is also possible to calculate the sensitivity based on other filtered values derived from the signals (para. [0039]).
Rantala does not disclose wherein said perturbing and said recovering are configured according to principles selected from single-tone perturbation; frequency key shifting; code division multiplexing; heterodyning; Wiener filtering; and combinations thereof.
However, Robertson directed to a system for providing a response to a dose of a substance and/or controls the administration of the dose discloses that perturbing and recovering (figs. 6-7, col. 12 lines 8-29) are configured according to principles selected from single-tone perturbation; frequency key shifting; code division multiplexing; heterodyning; Wiener filtering; and combinations thereof (“response may be determined … techniques: …Weiner filtering”, col. 15 lines 15-28 & col. 16 lines 14-24, figs. 6-7).
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 configured according to principles selected from single-tone perturbation; frequency key shifting; code division multiplexing; heterodyning; Wiener filtering; and combinations thereof, in view of the teachings of Robertson, as this would aid in determining the response of the patient to the dose of medicine given (Robertson, col. 15 lines 15-28 & col. 16 lines 14-24, figs. 6-7).
Regarding claim 17, Rantala discloses the system of claim 14 and that it is also possible to calculate the sensitivity based on other filtered values derived from the signals (para. [0039]).
Rantala does not disclose wherein said processor is configured to perturb the delivery amount and recover the effect of the perturbation according to principles selected from single-tone perturbation; frequency key shifting; code division multiplexing; heterodyning; Wiener filtering; and combinations thereof.
However, Robertson directed to a system for providing a response to a dose of a substance and/or controls the administration of the dose discloses the processor (“processor”, col. 18 lines 43-64) is configured to perturb the delivery amount and recover the effect of the perturbation (figs. 6-7, col. 12 lines 8-29) according to principles selected from single-tone perturbation; frequency key shifting; code division multiplexing; heterodyning; Wiener filtering; and combinations thereof (“response may be determined … techniques: …Weiner filtering”, col. 15 lines 15-28 & col. 16 lines 14-24, figs. 6-7).
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 processor is configured to perturb the delivery amount and recover the effect of the perturbation according to principles selected from single-tone perturbation; frequency key shifting; code division multiplexing; heterodyning; Wiener filtering; and combinations thereof, in view of the teachings of Robertson, as this would aid in determining the response of the patient to the dose of medicine given (Robertson, col. 15 lines 15-28 & col. 16 lines 14-24, figs. 6-7).
Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rantala in view of Bendriem (US 8058620 B2).
Regarding claim 7, Rantala discloses the method of claim 1. Rantala 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 such that the perturbation frequency maximizes a signal to noise ratio of the sensitivity, in view of the teachings of Bendriem, in order to provide an optimal dose and optimize subsequent sensitivity calibration.
Regarding claim 20, Rantala discloses the system of claim 14. Rantala does not disclose wherein said processor is configured to maintain the perturbation frequency so as to maximize 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 is maintained so as to maximize 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 such that said processor is configured to maintain the perturbation frequency so as to maximize a signal to noise ratio of the sensitivity, in view of the teachings of Bendriem, in order to provide an optimal dose and optimize subsequent sensitivity calibration.
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rantala in view of Selander (US 20210267506 A1).
Regarding claim 8, Rantala discloses the method of claim 1. Rantala 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 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.
Regarding claim 21, Rantala discloses the system of claim 14. Rantala does not disclose wherein said processor is configured to demodulate 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 a computing device 115/800 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 processor (device 115/800, para. [0090, 0194]) is configured to demodulate 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 such that said processor is configured to demodulate the patient response, in view of the teachings of Selander, as this would aid in extracting data from the received signals.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Heruth (US 20050216064 A1) directed to sensitivity analysis for selecting therapy parameter sets and discloses periodically perturbing at least one therapy parameter value of the baseline therapy parameter (para. [0008, 0041]); John (US 20130144183 A1) directed to a method of determining the correct anesthesia dosage for each patient, deriving a "transfer function" for each patient using perturbation analysis, and updating the transfer function at regular intervals (i.e., for example every 20 minutes) during the operation (para, [0047-0048]); Bibian (US 11109789 B1) directed to system and method for screening, assessing, and providing mitigating treatment to improve the short- and long-term adverse outcomes of mild TBI (mTBI) and TBI.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791