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 Status
Claims 1-13 are currently pending and under exam herein.
Claims 14-20 are withdrawn.
Claims 1-13 are rejected.
Claim 6 is objected to.
Elections/Restrictions
Claims 14-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed 09/08/2025.
Priority
The instant application claims benefit of U.S. Provisional Patent Application No. 63/177,009, filed April 20, 2021. At this point in the examination, the effective filing date of the claims is April 20, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed 08/10/2022 and 01/25/2023 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. The Information Disclosure Statements filed 08/11/2022 have been considered, in part. It is noted that certain references have not been considered and are lined-through, as they do not comply with the requirements set forth in 37 CFR 1.97. The instant citations lack appropriate dates and/or page numbers and/or other public information, for example, entry 27 lacks appropriate date and the listed website is inaccessible.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition, the drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Identifier “100” appears in Figure 1 , however it is not described in the specification, making the reference unclear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities: there are grammatical errors such as “sum of an amount past actual delivery”, “calculate a per cycle delivery amount of using” and “the therapeutic exogenous substance that has delivered to the user”, should read respectively “sum of an amount of past actual delivery”, “calculate a per cycle delivery amount by using” and “the therapeutic exogenous substance that has been delivered to the user”. 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.
Claim 7 recites the limitation “determine a minimum value between the estimated relative therapeutic exogenous substance concentration or a maximum insulin adjustment factor”, making it unclear whether the minimum value to be determined should be in range between the two mentioned options or whether it should be the minimum among the two. The rejection might be overcome by for example, amending the claim to recite “determine a minimum value between the estimated relative therapeutic exogenous substance and a maximum insulin adjustment factor”. For compact examination, it is assumed that the preceding suggested will be implemented.
Claim Interpretation
The claims in this application are given their broadest interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The interpretation of the following claims notifies the applicant of the interpretation of claim language to aid in the understanding of possible/rejections.
An element in Claim 7 recites “based on the determined minimum and Claims 7-9, Claim 11, Claim 12 and Claim 13 recite respectively “setting the insulin adjustment factor to be equal”; “set the maximum adjustment of the insulin adjustment factor”; “set the insulin adjustment factor as determined” and “set the insulin adjustment factor to one”, if a certain condition is met. The element in the claims is considered contingent and therefore not limitation of the claimed invention because the condition being met is not 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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgment, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106:
Eligibility Step 1: Claims 1-13 are directed to an automatic drug delivery device (machine). Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 1 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
estimate an amount of the therapeutic exogenous substance to deliver to a user (i.e., mental processes: estimation can be done mentally);
determine an insulin adjustment factor utilizing an estimated relative therapeutic exogenous substance concentration (i.e., mental process: determination of a value based on estimation can be done mentally and mathematical concepts: calculation);
calculate a compensating dose of the therapeutic exogenous substance based on the estimated amount of the therapeutic exogenous substance to deliver that is adjusted by the insulin adjustment factor (i.e., mathematical concepts: calculation);
Dependent claims 2-11 and 13 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 2 further recites:
modify the estimated amount of the therapeutic exogenous substance using the insulin adjustment factor (i.e., mathematical concepts: calculation since insulin adjustment factor is a value and mental processes: amount estimation can be done mentally);
Dependent claim 3 further recites:
and determine, based on the obtained total amount of the therapeutic exogenous substance, a total daily amount of the therapeutic exogenous substance that maintains the user within range of a target analyte measurement setting (i.e., mental process: determination of an amount can be done mentally);
Dependent claim 4 further recites:
determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary (i.e., mental process: determination can be done mentally);
and in response to the value of the estimated relative therapeutic exogenous substance concentration being within the maximum boundary and the minimum boundary, set the insulin adjustment factor to be equal to the therapeutic exogenous substance concentration (i.e., mental process: setting a value based on another value can be done mentally);
Dependent claim 5 further recites:
determine the estimated relative therapeutic exogenous substance concentration using a total daily amount of the therapeutic exogenous substance that maintained an analyte measurement value of the user within a range of a target analyte measurement setting (i.e., mental process: determination can be done mentally);
Dependent claim 6 further recites:
determine a sum of an amount past actual delivery of the therapeutic exogenous substance over a predetermined number of delivery cycles (i.e., mental process: determination of a sum can be done mentally and mathematical concepts: sum);
calculate a per cycle delivery amount of using a total amount of the therapeutic exogenous substance that has delivered to the user over a preset time period (i.e., mathematical concepts: calculation);
apply a tuning factor that corresponds to the predetermined number of delivery cycles to the calculated per cycle delivery amount to obtain a divisor (i.e., mathematical concepts: “tuning factor H” [0029] is part of an equation);
divide the sum of an amount past actual delivery of the therapeutic exogenous substance over a predetermined number of delivery cycles by the obtained divisor (i.e., mathematical concepts: division, sum);
Dependent claim 7 further recites:
determine a minimum value between the estimated relative therapeutic exogenous substance concentration or a maximum insulin adjustment factor (i.e., mental process: determination of a value can be done mentally);
based on the determined minimum, determine a maximum value between the estimated relative therapeutic exogenous substance concentration and a minimum boundary (i.e., mental process: determination of a value can be done mentally);
and in response to a value of the estimated relative therapeutic exogenous substance concentration being greater than the minimum boundary, set the insulin adjustment factor to be equal to the value of the estimated relative therapeutic exogenous substance concentration (i.e., mental process: setting a value based on another value can be done mentally);
Dependent claim 8 further recites:
determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary (i.e., mental process: determination can be done mentally);
and in response to the value of the estimated relative therapeutic exogenous substance concentration being greater than the maximum boundary, set the insulin adjustment factor to be equal to a maximum insulin adjustment factor (i.e., mental process: setting a value based on another value can be done mentally);
Dependent claim 9 further recites:
determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary (i.e., mental process: determination can be done mentally);
and in response to the value of the estimated relative therapeutic exogenous substance concentration being less than the minimum boundary, set the insulin adjustment factor to be equal to the minimum boundary (i.e., mental process: setting a value based on another value can be done mentally);
Dependent claim 10 further recites:
determine a maximum adjustment of the insulin adjustment factor (i.e., mental process: determining an adjustment based on a value can be done mentally);
Dependent claim 11 further recites:
calculate a per cycle amount of the therapeutic exogenous substance delivered over a preset time (i.e., mathematical concepts: calculation);
multiply the per cycle amount, a tuning factor and a maximum threshold value together (i.e., mathematical concepts: multiplication);
determine an amount of the therapeutic exogenous substance delivered over a period of time equal to the tuning factor (i.e., mental process: determination of an amount can be done mentally);
compare a result from the multiplying to the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor (i.e., mental process: comparing a result can be done mentally);
and based on a result of the comparing, set the maximum adjustment of the insulin adjustment factor (i.e., mental process: setting a result based on an amount can be done mentally);
Dependent claim 13 further recites:
in response to result of the comparing indicating that the result is less than or equal to the determined amount of the therapeutic exogenous substance delivered over a period of time equal to the tuning factor, set the insulin adjustment factor to one (i.e., mental process: setting a value in response to a comparison can be done mentally);
Therefore, claims 1-11 and 13 recite an abstract idea.
Step 2A Prong One: [YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
Claims 2, 4-5, 7-11 and 13 dot not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional element in independent claim 1 include:
a processor;
a reservoir configured to contain a therapeutic exogenous substance;
a pump mechanism communicatively coupled to the processor, and fluidically coupled to the reservoir;
and a memory coupled to the processor and configured to store a substance delivery history and programming code
causing the calculated compensating dose of the therapeutic exogenous substance to be expelled from the reservoir by the pump mechanism.
The additional elements in dependent claim 3 include:
obtain, from the substance delivery history stored in the memory, a total amount of the therapeutic exogenous substance that has been delivered to the user over a preset time period
The additional elements in dependent claim 6 include:
and store a quotient of the dividing that is the estimated relative therapeutic exogenous substance concentration
The additional elements in dependent claim 12 include:
in response to result of the comparing indicating that the result is greater than the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor, set the insulin adjustment factor as determined to account for production of an endogenous insulin related to the therapeutic exogenous substance administered by the automatic drug delivery device
The additional elements of a processor, a drug containing reservoir, with a mechanical pump (claim 1), memory to store data (claims 1, 3, and 6), and a drug delivery device (claim 12) are insignificant extra-solution activities that are part of the data gathering process used in the recited judicial exceptions (see MPEP 2106.05(g).
When all limitations in claims 1-13 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-13 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because the reasons noted below.
Claims 2, 4-5, 7-11 and 13 dot not recite any elements in addition to the judicial exception(s).
The additional elements recited in claims 1,3,6 and 12 are identified above, and carried over from Step 2A: Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at step Step 2A: Prong Two was re-evaluated at step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional element of claims 1 include:
a processor
a memory coupled to a processor configured to store a substance delivery history and programming code
a reservoir configured to contain a therapeutic exogenous substance
a pump mechanism communicatively coupled to the processor, and fluidically coupled to the reservoir
substance to be expelled from the reservoir by the pump mechanism
The additional elements of claims 3 and 6 include:
substance delivery history stored in the memory
and store a quotient
The additional element in claim 12 include:
the therapeutic exogenous substance administered by the automatic drug delivery device
One or more processors and memory are conventional computer components. The courts
have found the use of a computer or other machinery in its ordinary capacity for economic
or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose
computer or computer components after the fact to an abstract idea (e.g., a fundamental
economic practice or mathematical equation) does not provide significantly more. See
Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016)
(cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118
USPQ2d 1744, 1748 (Fed. Cir. 2016). In addition, conventionally is shown by a review article from 2012, in which Li et al. (“Compact, power-efficient architectures using microvalves and microsensors, for intrathecal, insulin, and other drug delivery systems, Advanced Drug Delivery Reviews, Volume 64, Issue 14, 2012, Pages 1639-1649, ISSN 0169-409X), demonstrate a variety of insulin and other drug delivery systems/devices that include reservoirs (abstract, line 5, pg.1639), drug delivery pump mechanisms (col.1, para.1, lines 1-8, pg. 1640), memory (col.1, para. 3, line 8, pg. 1645), and a processor (col.1, para.7, line 4, pg. 1645). Furthermore, the additional elements of storing data in claims 1, 3 and 6 and a memory coupled to a processor, and receiving input data/receiving patient data are insignificant extra-solution activity that are part of the data gathering process used in the recited judicial exceptions (see MPEP 2106.05(g)). Therefore, when taken alone, all additional elements in claims 1,3,6 and 12, do not amount to significantly more than the above-identified judicial exceptions(s). Even when evaluated as combination, the additional elements fail to transform the exceptions (s) into patent-eligible application of that exception. Thus, claims 1-13 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
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 1-3, 7-10, and 12-13 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Hayter et al. (US 2021/0050085; 8/11/2022 IDS document). The italicized text corresponds to the instant claim limitations.
Claim 1 is drawn to an automated exogenous substance dispensing device, that contains a processor, a reservoir to hold the exogenous substance, a pump mechanism that coupled to the processor, and to the reservoir, the processor is coupled with memory that stores the substance’s dispensing history data, and a programming code that, when executed by the processor, cause the drug dispensing device to: (a) estimate an amount of the exogenous insulin to deliver to a user, (b) determine an insulin adjustment factor using exogenous insulin estimate “estimated relative insulin concentration”, (c) calculate a compensatory dose of the exogenous insulin based on its estimated amount of exogenous insulin to deliver that is adjusted by the insulin sensitivity factor; (d) and cause the calculated compensating dose of the insulin to be expelled from the reservoir by the pump mechanism. In some embodiments the estimated amount of the therapeutic exogenous substance is changed using the insulin adjustment factor (claim 2); obtain, from the insulin delivery history stored in the memory, a total amount of the exogenous insulin that has been delivered to the user over a preset time period (claim 3); comparing the estimated relative insulin concentration to a maximum allowed adjustment factor, comparing the result to a minimum boundary, and if the estimated concentration is above the minimum boundary, set the insulin adjustment factor equal to that value (claim 7); determinizing whether the estimated relative drug concentration falls within a minimum limit and a maximum limit, and if the estimated is greater than the maximum boundary, set the insulin adjustment factor equal to a maximum permitted insulin adjustment factor (claim 8); determining whether the estimated concentration falls within a minimum and maximum range, and if the estimated concentration is less than the minimum boundary, set the insulin adjustment factor equal to the minimum boundary (claim 9); determining a maximum permitted adjustment of the insulin adjustment factor (claim 10); if the comparison shows that the calculated value is greater than the actual amount of therapeutic insulin delivered over the period of time, set the insulin adjustment factor in way that accounts for the body’s own insulin production resulting from the administered insulin (Claim 12); and if the comparison shows that the calculated value is less than or equal to the amount of insulin delivered over the period of time, set the insulin adjustment factor to one (claim 13).
With respect to claim 1, Hayter et al. discloses a medication delivery device 152 that can be any device configured to deliver a specific dose of medication (0083, lns.4-5, pg.6) and that it can be automatic (0085, lns.1-5, pg.6; An automatic drug delivery device). Hayter et al. discloses the medication delivery device having a processor (0089, ln.12, pg.7; comprising: a processor). Hayter et al. discloses a reservoir 163 containing a medication (0089, lns.9-10, pg.7; a reservoir configured to contain a therapeutic exogenous substance). Hayter et al. discloses a pump device that electronics (such as a processor) for interfacing with the user and for controlling the slow infusion of the medication, and further explains that the pump is can store the medication in a reservoir (0084, lns.9-12, pg.6; a pump mechanism communicatively coupled to the processor, and fluidically coupled to the reservoir). Hayter et al. discloses a dose guidance application (DGA) that includes software and/or firmware instructions stored in a memory of a computing device for execution by at least one processor (0053, lns.1-4, pg.3; and a memory coupled to the processor). Hayter et al. discloses that the DGA can automatically generate possible bolus insulin doses based on past dosing history (0213, Fig.9A, lns.3-5, pg.21; and configured to store a substance delivery history and programming code that, when executed by the processor, cause the drug delivery device to: estimate an amount of the therapeutic exogenous substance to deliver to a user). Hayter et al. discloses that dose guidance parameter estimates can include, but are not limited to, estimated insulin sensitivity factor/insulin correction factor (0206, col.2, lns.4-4, pg.20; determine an insulin adjustment factor) and that it uses exogenous insulin amounts (0243, col.1, lns. 15-22, pg. 24; determine an insulin adjustment factor utilizing an estimated relative therapeutic exogenous substance concentration). Hayter et al. discloses calculating an exogenous insulin dose to deliver to the patient based on the correction factor (0522; lns.1-3, pg.51; calculate a compensating dose of the therapeutic exogenous substance based on the estimated amount of the therapeutic exogenous substance to deliver that is adjusted by the insulin adjustment factor). Hayter et al. discloses a medication delivery device 152 that can be any device configured to deliver a specific dose of medication (0083, lns.4-5, pg.6; and causing the calculated compensating dose of the therapeutic exogenous substance to be expelled from the reservoir by the pump mechanism).
Regarding claim 2, Hayter et al. discloses that the exogenous insulin dose (U) is calculated using the correction factor (CF), so that by changing the correction factor changes the amount of insulin delivered (0214, eq.1, pg. 21; modify the estimated amount of the therapeutic exogenous substance using the insulin adjustment factor).
Regarding claim 3, Hayter et al. discloses that exogenous insulin metric can be a total dose of insulin within a time period (0392, lns.2-4, pg. 39), that outcome metric can include time in range (0206, col.1-2, lns.6-8, pg.20) and that the insulin dose can be generated based on a past history of the subject’s basal doses (0237, col.2, lns. 4-7, pg.23; obtain, from the substance delivery history stored in the memory, a total amount of the therapeutic exogenous substance that has been delivered to the user over a preset time period).
Regarding claim 7, Hayter et al. discloses adjusting insulin based on a comparison to a boundary (0305;eq.7, para.2, lns.1-7, pg.31) and that the correction factor can be adjusted as a parameter coming from analyte levels (0430, lns.4-7, pg.43; determine a minimum value between the estimated relative therapeutic exogenous substance concentration or a maximum insulin adjustment factor; based on the determined minimum, determine a maximum value between the estimated relative therapeutic exogenous substance concentration and a minimum boundary; and in response to a value of the estimated relative therapeutic exogenous substance concentration being greater than the minimum boundary, set the insulin adjustment factor to be equal to the value of the estimated relative therapeutic exogenous substance concentration).
Regarding claim 8, Hayter et al. discloses a defined low threshold and high threshold and determining whether glucose falls within or outside those limits (0119; Fig.6, col.2, lns. 17-22, pg. 10) and enforcing a safety limit that constrains insulin adjustment when conditions exceed such boundary (0297, col.2, lns.11-13, pg.30; determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary; and in response to the value of the estimated relative therapeutic exogenous substance concentration being greater than the maximum boundary, set the insulin adjustment factor to be equal to a maximum insulin adjustment factor).
Regarding claim 9, Hayter et al. discloses modifying the adjustment factor when values fall outside a desired range as the system limits the dose to a constrained level, meaning enforcing a minimum threshold on the adjustment (0262, lns.9-11, pg.26) and (0334, col.1-2, lns.2-4, pg.34; determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary; and in response to the value of the estimated relative therapeutic exogenous substance concentration being less than the minimum boundary, set the insulin adjustment factor to be equal to the minimum boundary).
Regarding claim 10, Hayter et al. discloses determining an analyte pattern type for at least one TOD period by executing a glucose pattern analysis- GPA algorithm, the algorithm constrains how the factor can change (a maximum amount), meaning the system determines an allowable adjustment to the insulin correction factor used in dose calculations (Fig.10A; determine a maximum adjustment of the insulin adjustment factor).
Regarding claim 12, Hayter et al. discloses determining a factor corresponding to endogenous insulin (636) and modifying the dose guidance using the factor (638), meaning adjusting the insulin dosing calculation to account for endogenous insulin (Fig.12C; in response to result of the comparing indicating that the result is greater than the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor, set the insulin adjustment factor as determined to account for production of an endogenous insulin related to the therapeutic exogenous substance administered by the automatic drug delivery device).
Regarding claim 13, Hayter et al. discloses reducing correction adjustments when glucose patterns indicate that more insulin correction is not needed or too much. Reducing or eliminating the correction mean applying no adjustment to the insulin dose, which is the same as using an adjustment factor of 1 (Fig.10A-B, Fig.8E; in response to result of the comparing indicating that the result is less than or equal to the determined amount of the therapeutic exogenous substance delivered over a period of time equal to the tuning factor, set the insulin adjustment factor to one).
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.
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, 7-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. (US 2021/0050085; 8/11/2022 IDS document). The italicized text corresponds to the instant claim limitations.
Claim 1 is drawn to an automated exogenous substance dispensing device, that contains a processor, a reservoir to hold the exogenous substance, a pump mechanism that coupled to the processor, and to the reservoir, the processor is coupled with memory that stores the substance’s dispensing history data, and a programming code that, when executed by the processor, cause the drug dispensing device to: (a) estimate an amount of the exogenous insulin to deliver to a user, (b) determine an insulin adjustment factor using exogenous insulin estimate “estimated relative insulin concentration”, (c) calculate a compensatory dose of the exogenous insulin based on its estimated amount of exogenous insulin to deliver that is adjusted by the insulin sensitivity factor; (d) and cause the calculated compensating dose of the insulin to be expelled from the reservoir by the pump mechanism. In some embodiments the estimated amount of the therapeutic exogenous substance is changed using the insulin adjustment factor (claim 2); obtain, from the insulin delivery history stored in the memory, a total amount of the exogenous insulin that has been delivered to the user over a preset time period (claim 3); comparing the estimated relative insulin concentration to a maximum allowed adjustment factor, comparing the result to a minimum boundary, and if the estimated concentration is above the minimum boundary, set the insulin adjustment factor equal to that value (claim 7); determinizing whether the estimated relative drug concentration falls within a minimum limit and a maximum limit, and if the estimated is greater than the maximum boundary, set the insulin adjustment factor equal to a maximum permitted insulin adjustment factor (claim 8); determining whether the estimated concentration falls within a minimum and maximum range, and if the estimated concentration is less than the minimum boundary, set the insulin adjustment factor equal to the minimum boundary (claim 9); determining a maximum permitted adjustment of the insulin adjustment factor (claim 10); if the comparison shows that the calculated value is greater than the actual amount of therapeutic insulin delivered over the period of time, set the insulin adjustment factor in way that accounts for the body’s own insulin production resulting from the administered insulin (Claim 12); and if the comparison shows that the calculated value is less than or equal to the amount of insulin delivered over the period of time, set the insulin adjustment factor to one (claim 13).
With respect to claim 1, Hayter et al. discloses a medication delivery device 152 that can be any device configured to deliver a specific dose of medication (0083, lns.4-5, pg.6) and that it can be automatic (0085, lns.1-5, pg.6; An automatic drug delivery device). Hayter et al. discloses the medication delivery device having a processor (0089, ln.12, pg.7; comprising: a processor). Hayter et al. discloses a reservoir 163 containing a medication (0089, lns.9-10, pg.7; a reservoir configured to contain a therapeutic exogenous substance). Hayter et al. discloses a pump device that electronics (such as a processor) for interfacing with the user and for controlling the slow infusion of the medication, and further explains that the pump is can store the medication in a reservoir (0084, lns.9-12, pg.6; a pump mechanism communicatively coupled to the processor, and fluidically coupled to the reservoir). Hayter et al. discloses a dose guidance application (DGA) that includes software and/or firmware instructions stored in a memory of a computing device for execution by at least one processor (0053, lns.1-4, pg.3; and a memory coupled to the processor). Hayter et al. discloses that the DGA can automatically generate possible bolus insulin doses based on past dosing history (0213, Fig.9A, lns.3-5, pg.21; and configured to store a substance delivery history and programming code that, when executed by the processor, cause the drug delivery device to: estimate an amount of the therapeutic exogenous substance to deliver to a user). Hayter et al. discloses that dose guidance parameter estimates can include, but are not limited to, estimated insulin sensitivity factor/insulin correction factor (0206, col.2, lns.4-4, pg.20; determine an insulin adjustment factor) and that it uses exogenous insulin amounts (0243, col.1, lns. 15-22, pg. 24; determine an insulin adjustment factor utilizing an estimated relative therapeutic exogenous substance concentration). Hayter et al. discloses calculating an exogenous insulin dose to deliver to the patient based on the correction factor (0522; lns.1-3, pg.51; calculate a compensating dose of the therapeutic exogenous substance based on the estimated amount of the therapeutic exogenous substance to deliver that is adjusted by the insulin adjustment factor). Hayter et al. discloses a medication delivery device 152 that can be any device configured to deliver a specific dose of medication (0083, lns.4-5, pg.6; and causing the calculated compensating dose of the therapeutic exogenous substance to be expelled from the reservoir by the pump mechanism).
Regarding claim 2, Hayter et al. discloses that the exogenous insulin dose (U) is calculated using the correction factor (CF), so that by changing the correction factor changes the amount of insulin delivered (0214, eq.1, pg. 21; modify the estimated amount of the therapeutic exogenous substance using the insulin adjustment factor).
Regarding claim 3, Hayter et al. discloses that exogenous insulin metric can be a total dose of insulin within a time period (0392, lns.2-4, pg. 39), that outcome metric can include time in range (0206, col.1-2, lns.6-8, pg.20) and that the insulin dose can be generated based on a past history of the subject’s basal doses (0237, col.2, lns. 4-7, pg.23; obtain, from the substance delivery history stored in the memory, a total amount of the therapeutic exogenous substance that has been delivered to the user over a preset time period).
Regarding claim 7, Hayter et al. discloses adjusting insulin based on a comparison to a boundary (0305;eq.7, para.2, lns.1-7, pg.31) and that the correction factor can be adjusted as a parameter coming from analyte levels (0430, lns.4-7, pg.43; determine a minimum value between the estimated relative therapeutic exogenous substance concentration or a maximum insulin adjustment factor; based on the determined minimum, determine a maximum value between the estimated relative therapeutic exogenous substance concentration and a minimum boundary; and in response to a value of the estimated relative therapeutic exogenous substance concentration being greater than the minimum boundary, set the insulin adjustment factor to be equal to the value of the estimated relative therapeutic exogenous substance concentration).
Regarding claim 8, Hayter et al. discloses a defined low threshold and high threshold and determining whether glucose falls within or outside those limits (0119; Fig.6, col.2, lns. 17-22, pg. 10) and enforcing a safety limit that constrains insulin adjustment when conditions exceed such boundary (0297, col.2, lns.11-13, pg.30; determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary; and in response to the value of the estimated relative therapeutic exogenous substance concentration being greater than the maximum boundary, set the insulin adjustment factor to be equal to a maximum insulin adjustment factor).
Regarding claim 9, Hayter et al. discloses modifying the adjustment factor when values fall outside a desired range as the system limits the dose to a constrained level, meaning enforcing a minimum threshold on the adjustment (0262, lns.9-11, pg.26) and (0334, col.1-2, lns.2-4, pg.34; determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary; and in response to the value of the estimated relative therapeutic exogenous substance concentration being less than the minimum boundary, set the insulin adjustment factor to be equal to the minimum boundary).
Regarding claim 10, Hayter et al. discloses determining an analyte pattern type for at least one TOD period by executing a glucose pattern analysis- GPA algorithm, the algorithm constrains how the factor can change (a maximum amount), meaning the system determines an allowable adjustment to the insulin correction factor used in dose calculations (Fig.10A; determine a maximum adjustment of the insulin adjustment factor).
Regarding claim 12, Hayter et al. discloses determining a factor corresponding to endogenous insulin (636) and modifying the dose guidance using the factor (638), meaning adjusting the insulin dosing calculation to account for endogenous insulin (Fig.12C; in response to result of the comparing indicating that the result is greater than the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor, set the insulin adjustment factor as determined to account for production of an endogenous insulin related to the therapeutic exogenous substance administered by the automatic drug delivery device).
Regarding claim 13, Hayter et al. discloses reducing correction adjustments when glucose patterns indicate that more insulin correction is not needed or too much. Reducing or eliminating the correction mean applying no adjustment to the insulin dose, which is the same as using an adjustment factor of 1 (Fig.10A-B, Fig.8E; in response to result of the comparing indicating that the result is less than or equal to the determined amount of the therapeutic exogenous substance delivered over a period of time equal to the tuning factor, set the insulin adjustment factor to one).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. (US 2021/0050085; 8/11/2022 IDS document) in view of Doyle et al. (US2020/0078516A1) as applied to claims 1-3, 7-10, and 12-13.
Claim 4 is drawn to when defining the insulin adjustment factor, determining that the insulin amount has a value within a maximum boundary and a minimum boundary and if so, set the insulin adjustment factor to be equal to the insulin amount. Determine the estimated insulin concentration using a total daily amount of the insulin that maintained an analyte measurement value of a user within a range. Claim 5 is drawn to determine the estimated relative insulin amount using a total daily amount of the exogenous insulin that maintained an analyte measurement value of the user within a range of a target analyte measurement setting.
The limitations of claims 1-3, 7-10, and 12-13 have been taught by Hayter et al. above.
Hayter et al. is silent to when defining the insulin adjustment factor, determining that the insulin amount has a value within a maximum boundary and a minimum boundary; and if so, set the insulin adjustment factor to be equal to the insulin amount; determining the estimated relative insulin amount using a total daily amount of the exogenous insulin that maintained an analyte measurement value of the user within a range of a target analyte measurement setting.
Regarding claim 4, Doyle et al. discloses the use of a scaling factor to incorporate a subject’s basal insulin injection characteristics in the control algorithm of an artificial pancreas system, which directed the delivery of insulin to be administered to subjects with diabetes. The scaling factor (0034, col.1, ln.5, pg.3) is equal to a ratio of two insulin basal rates, i.e., a relative insulin concentration (0034, eq 6, pg. 3). Doyle et al. further discloses that a defined minimum and maximum boundaries of a parameter that is used to calculate the insulin basal rates (0034, eq 8, pg.3; determine whether the estimated relative therapeutic exogenous substance concentration has a value within a maximum boundary and a minimum boundary; and in response to the value of the estimated relative therapeutic exogenous substance concentration being within the maximum boundary and the minimum boundary, set the insulin adjustment factor to be equal to the therapeutic exogenous substance concentration)
Regarding claim 5, Doyle et al. discloses the scaling factor (0034, col.1, ln.5, pg.3) being equal to a ratio of two insulin basal rates, i.e., a relative insulin concentration, with equation 6 further including calculation of the subject’s actual basal insulin injection characteristic (0034, eq 6, pg. 3; determine the estimated relative therapeutic exogenous substance concentration using a total daily amount of the therapeutic exogenous substance that maintained an analyte measurement value of the user within a range of a target analyte measurement setting).
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify the medical device from Hayter et al. with the insulin correction factor adjustments of Doyle et al., because Doyle et al., shows that “PID controllers that incorporate this scheme can exhibit improved performance, as shown in both model simulations and a clinical trial” (0005, col.1, lns.3-5, pg.1). A person of ordinary skill in the art would therefore have been motivated to add the insulin correction factor adjustments of Doyle et al., to improve control and ensure that the device does not over or under deliver insulin to the subject. One would have had a reasonable expectation of success for making this combination because not only both references are in the field of Proportional-Integral-Derivative (PID) controllers in insulin pumps, but also because further adjustments to the correction factor would lead to better control and improve performance.
Claim 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. (US 2021/0050085; 8/11/2022 IDS document) in view of Doyle et al. (US2020/0078516A1) as applied to claims 1-5, 7-10, and 12-13, and further in view of Bryan Mazlish. (US 2015/0352282 A1) and Scheerans et al. (Biopharmaceutics & Drug Disposition, Vol. 36, No. 2, 21 Jan. 2015, Pp. 93–103).
Claim 6 is drawn to (a) adding how much insulin was delivered over delivery cycles; (b) determine an average amount delivered per cycle over a set time period; (c) adjust the per cycle amount using a tuning factor; (d) obtain a ratio (dividing the total past delivery amount from a by the value from c); (e) and store the ratio as the estimated relative drug concentration. Claim 11 is drawn to (a) finding an average amount delivered per cycle during a preset time period; (b) scaling the per cycle delivery using a tuning factor and a threshold;(c) determining how much insulin was delivered during a specific time period tied to the tuning factor; (d) compare a scaled projected value to the actual delivered amount; (e)use the comparison result to decide what the maximum allowed adjustment should be.
The limitations of claims 1-5, 7-10, and 12-13 have been taught by Hayter et al. and Doyle et al. above.
Hayter et al. and Doyle et al. are silent to determining a sum of an amount of past actual delivery of the therapeutic exogenous substance over a predetermined number of delivery cycles; calculating a per cycle delivery amount by using a total amount of the insulin that has been delivered to the user over a preset time period; apply a tuning factor that corresponds to the predetermined number of delivery cycles to the calculated per cycle delivery amount to obtain a divisor (claim 6) and calculating a per cycle amount of the therapeutic exogenous substance delivered over a preset time; multiplying the per cycle amount, a tuning factor and a maximum threshold value together; determining an amount of the therapeutic exogenous substance delivered over a period of time equal to the tuning factor; comparing a result from the multiplying to the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor; and based on a result of the comparing, setting the maximum adjustment of the insulin adjustment factor (claim 11).
Regarding claim 6, Bryan Mazlish. discloses summing past insulin deliveries over time increments “cycles” (0055, col.2, lns.1-16, pgs. 5-6; determine a sum of an amount past actual delivery of the therapeutic exogenous substance over a predetermined number of delivery cycles). Bryan Mazlish. discloses calculating per cycle amounts (0.1 units) from a total amount (6 units) over a preset time period (0055, col.2, lns.1-8, pg.5; calculate a per cycle delivery amount of using a total amount of the therapeutic exogenous substance that has delivered to the user over a preset time period). Bryan Mazlish. discloses a tuning factor “fraction of absorption remaining”, which is applied to each dose based on how much of it is still active to calculate the IOB number (0053, col.2, lns. 1-7, pg.5; apply a tuning factor that corresponds to the predetermined number of delivery cycles to the calculated per cycle delivery amount to obtain a divisor).
Bryan Mazlish. is silent to dividing the sum of an amount past actual delivery of the therapeutic exogenous substance over a predetermined number of delivery cycles by the obtained divisor; and storing a quotient of the dividing that is the estimated relative therapeutic exogenous substance concentration and calculating a per cycle amount of the therapeutic exogenous substance delivered over a preset time; multiplying the per cycle amount, a tuning factor and a maximum threshold value together; determining an amount of the therapeutic exogenous substance delivered over a period of time equal to the tuning factor; comparing a result from the multiplying to the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor; and based on a result of the comparing, setting the maximum adjustment of the insulin adjustment factor.
Scheerans et al. discloses a ratio derived from cumulative prior drug delivery (Eq.4, pg.97 and col.1, para.1, lns.1-5, pg.97; divide the sum of an amount past actual delivery of the therapeutic exogenous substance over a predetermined number of delivery cycles by the obtained divisor). Scheerans et al. discloses the ratio is used as a value that represents relative drug concentration, as a ratio of 1.25% means a 125% steady-state exposure (Fig 2 and col.1, para.1, lns. 1-6, pg. 100; and store a quotient of the dividing that is the estimated relative therapeutic exogenous substance concentration).
Regarding claim 11, Scheerans et al. discloses an average amount of substance exposure over a dosing cycle/delivery cycle (Fig1. And Eq2; col.2, para.4, lns.1-5, pg.95). Scheerans et al. discloses the AUC-based accumulation ratio, a scaling metric which acts a tuning factor, multiplying a baseline value to adjust the result (col.1, para.2, lns.1-3, pg.100) and a boundary for the scaling factor (Fig.2, and col.1, para.4, lns.5-8, pg.101). Scheerans et al. discloses showing how much insulin was delivered in a time period by computing an interval total and then breaking it into specific time windows (Fig.1, col.2, para.3, lns.10-11, pg.96) and that is tied to a tuning factor because the amount of contact that if left after the dosing intervals is needed to determine the scaling factor used to predict accumulation across cycles (col.2, para.1, lns.1-8, pg.100; multiply the per cycle amount, a tuning factor and a maximum threshold value together). Scheerans et al. discloses comparing a scaled projected value to the actual delivered amount as the predicted value is linked to the measured accumulation over many dosing cycles (col.2, para.1, lns.1-5, pg. 100; compare a result from the multiplying to the determined amount of the therapeutic exogenous substance delivered over the period of time equal to the tuning factor). Scheerans et al. discloses using the comparison result to decide the maximum allowed adjustment by showing a threshold based on the predicted accumulation (col.2, para.2, lns.1-6, pg.100) and that the threshold has a limit (col.1, para.4, lns.5-7, pg. 101; and based on a result of the comparing, set the maximum adjustment of the insulin adjustment factor).
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify the medical device from Hayter et al. with the insulin correction factor adjustments of Doyle et al., with the calculations for estimating relative drug concentration of Bryan Mazlish. and Scheerans et al., because Scheerans et al. points out that calculations “can be considered as leading to non-relevant drug accumulation for any drug that shows dose and time linear pharmacokinetics” (col.1, para.4, lns.6-9, pg. 101) and Bryan Mazlish. shows that steps can be taken to “improve glycemic control in insulin delivery systems” (0013, col.1, lns. 19-23, pg.2). A person of ordinary skill in the art would therefore have been motivated to combine these teachings because Scheerans et al., suggests that calculations can be used for any drug that shows dose and time linear pharmacokinetics and Bryan Mazlish., shows improved glycemic control using automated devices. One would have had a reasonable expectation of success for making this combination because not only both references are in the field of delivering medical substances, but because they provide ways to improve glycemic control.
Conclusion
No claims are allowed.
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/A.S.E./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687