DETAILED ACTION
This office action is based on the claim set filed on 03/13/2026.
Claims 21, 29, and 38 have been amended.
Claims 21-40 are currently pending and have been examined.
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 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.
Claim 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 21-37 are drawn to a system and Claim 38-40 are drawn to an art of manufacturer, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 21-40 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for monitoring glucose and insulin does recommendation. Collecting a user glucose data to calculate average value over time and recommend an insulin does are steps that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Metal Process that can be performed using human mind with the aid of pencil and paper.
Independent Claim 1 recites the steps of:
“an injection pen device configured to administer insulin to a patient; one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of:
aggregating glucose data, insulin data, and carbohydrates consumption data associated with a patient;
selecting time periods based on insulin doses administered to the patient using the injection pen device temporally proximate to a meal consumed by the patient;
excluding, from the selected time periods, time periods with at least one of a blood glucose correction that is greater than a threshold blood glucose correction or an amount of insulin active within the patient that is greater than a threshold amount of insulin;
calculating, subsequent to the excluding, an average value of a post-meal glucose level of the patient over the selected time periods remaining after the excluding and across a plurality of meals consumed by the patient;
adjusting or maintaining a meal bolus insulin dose recommendation for administration using the injection pen device to the patient based on the average value of the post-meal glucose level of the patient”.
Independent Claim 29 recites the steps of:
an injection pen device configured to administer medicine to a patient; and a software application installable on a mobile communication device in communication with the injection pen device, the mobile communication device having one or more processors and one or more processor-readable media storing the software application which, when executed by the one or more processors, causes performance of:
Independent Claim 29 recites similar steps as in Claim 21
Independent Claim 38 recites the steps of:
One or more non-transitory processor readable media storing instructions which, when executed by one or more processors, cause performance of:
Independent Claim 38 recites similar steps as in Claim 21 including:
displaying the adjusted or maintained meal bolus insulin dose recommendation on at least one of a display of a mobile communication device or a display of an injection pen device
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper reciting an abstract idea for Mental Process along with Mathematical Calculations and relationships that constitute Mathematical Concepts but for the recitation of generic computer components. For example, calculating average value of glucose level, is Mathematical Concepts. For example, the limitations encompass a user the ability to collect a user data that includes glucose, insulin, carb., and time periods of doses administration to calculate average value of glucose level and recommend a dose accordingly, which are steps that that could have been performed by a human to implement the abstract idea and are steps reciting mental process that could have been performed using a human mind with aid of pen and paper and mathematical concepts, but other than the mere nominal recitation of "processor, readable media", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, non-transitory processor readable media, injection pen device, mobile device” that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions, e.g., “storing, displaying”, for calculating glucose level and displaying recommended dose such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 22-28, 30-37, and 39-40 include all of the limitations of claim(s) 21, 29, and 38, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 22-27, 30, 32-35, and 39-40, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process but for the recitation of generic computer components. The claims recite additional elements “processor” that implement the identified abstract idea. These hardware components are recited at a high level of generality to perform the steps that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 26-28, 31, and 36-37, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process” but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Subject Matter Free of Prior Art
Claims 21-40 have been found by the examiner to be free of prior art. A thorough search of the prior art was conducted and the examiner could not find a single reference or combination of references with adequate rationale to combine that would teach the claimed invention.
Regarding independent claim 21, and similarly claims 19 and 20, none of the prior art teach or fairly suggests the limitation of “calculating, subsequent to the excluding, an average value of a post-meal glucose level of the patient over the selected time periods remaining after the excluding and across a plurality of meals consumed by the patient”. The closest prior art of record is/are:
- Marcus et al. (US 2008/0071580) teaches calculating average blood glucose or sensor glucose readings for specified timeframes of selected meal event and provide an outcome where it shows events such as manual bolus and correction and excluding time periods where correction bolus was administered, however does not expressly teach calculating average blood glucose or sensor glucose readings for specified timeframes after or subsequent to excluding the events where correction was greater than a threshold.
- INAI HIROYUKI (JP6330966B1) teaches measurement of an average value of blood sugar levels during a time period and determine if the value exceed the upper limit or falls below the lower limit and accordingly issue instruction to change or adjust the amount of insulin based on the determined limit level or no instruction is issued to change insulin but does not expressly teach calculating the average glucose after or subsequent to excluding the events where correction was greater than a threshold.
- Mazlish et al. (US 2017/0203036) teaches delivery of insulin to a person with diabetes (PWD) based on the PWD's blood glucose levels and/or occlusion detector data where the deliveries of insulin basal is monitored not to exceed specific units.
- Booth et al. (US 20170228518) teaches obtaining blood glucose data of a patient that includes blood glucose measurements, blood glucose times, and insulin dosages previously administered by the patient and applying a set of filters to identify which of the blood glucose measurements associated with one of the scheduled time intervals are usable and which measurements associated with the scheduled time interval are unusable to determine a representative aggregate blood glucose measurement and determining a next recommended insulin dosage for the patient.
- Campbell et al. (US 2012/0150144) teaches calculating insulin on board (IOB) for an extended bolus being delivered by an insulin infusion pump used to calculate a suggested bolus.
- Desborough et al. (US 2018/0200441) teaches obtaining blood glucose readings of a user for generating a set of insulin delivery actions that may include delivery of a baseline basal rate and determine whether the previous insulin delivery actions include insulin beyond a threshold amount and adjusting the set of insulin delivery actions.
However, no prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, as disclosed in the claimed invention.
Response to Amendment
Applicant's arguments filed 03/03/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 8-11.
On page 8-9 of the remarks, Applicant argues that the claims are not directed to a judicial exception arguing “The claims are directed to a technological system that generates insulin dose recommendations in connection with a medical injection device... These operations are performed by processors executing stored instructions in a system that includes an insulin injection device and therefore do not constitute ... the claims do not recite a judicial exception under Step 2A, Prong One.” Examiner respectfully disagrees. The claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. The claim limitations, given their broadest reasonable interpretation, recite steps, i.e., analyzing/calculating a patient medicine dose information based on the received information of the patient over a period of time to adjust or remain the recommended dose for administration, which have been analyzed under Step 2A, Prong One reciting, at best, storing and using stored data (remembering), obtaining user information, medication status information, and historical usage data (observation), and calculating one or more parameter values based on the obtained information (evaluation) and determine to adjust or maintain a recommendation (judgment and opinion). These mimic human thought processes but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Mental Process. The 2019 Guidance identifies "concepts performed in the human mind (including an observation, evaluation, judgment, opinion)" as mental processes, and a category of abstract ideas. (2019 Guidance at 52 (footnote omitted); see also id. at n.15 (quoting Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139 (Fed. Cir. 2016) (mental processes can include claim steps that may be performed "mentally or by pencil and paper")); see also Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) ("Courts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person's mind.").
On page 9 of the remarks, Applicant argues that the claims are not directed to a judicial exception arguing “Even assuming, solely for the sake of argument, that the claims were considered to recite an abstract idea, the claims clearly integrate any such concept into a practical application involving a medical device system ... These operations are performed by processors executing stored instructions in a system that includes an insulin injection device and therefore do not constitute ... the claims do not recite a judicial exception under Step 2A, Prong One... the claims apply any alleged abstract concept within a specific technological framework involving physiological data processing and an insulin injection device, and therefore integrate any such concept into a practical application,” Examiner respectfully disagrees. While the claims, under BRI, recite steps such as collecting, analyzing/calculating, adjusting or maintain recommendation that encompass a judicial exception to define the identified abstract idea, the claims recite additional elements that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, e.g., an injection pen device to inject or administer medication to the patient. The claim(s), as a whole, recites an abstract idea for identifying a tracking a recommended dose of medicine and nowhere the claims nor the specification recite a technical solution improving the functioning of a computer or improves another technology or technical field rather the claimed invention is describing a solution addressing an administrative and clinical solution for identifying recommended medication dose for patient entities according to data processing and will not cause the claim to be "directed to" something other than an abstract idea.
As discussed in the rejection above, the components of the instant system, when taken alone, each execute in a manner conventionally expected of these components. At best, Applicant has claimed features that may improve an abstract idea. However, an improved abstract idea is still abstract, (SAP America v. Investpic *2-3 ("'We may assume that the techniques claimed are "groundbreaking, innovative, or even brilliant," but that is not enough for eligibility. Nor is it enough for subject-matter eligibility that claimed techniques be novel and nonobvious in light of prior art, passing muster under 35 U.S.C. §§ 102 and 103. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 89-90 (2012); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016) ("[A] claim for a new abstract idea is still an abstract idea”.
On page 10 of the remarks, Applicant argues “Even if the claims were considered to recite a judicial exception and were not found to integrate that exception into a practical application, the claims nonetheless recite an inventive concept that amounts to significantly more than any alleged abstract idea... The claims therefore recite a particular sequence of processor-executed operations performed in a system ... Because the claims recite this ordered combination of elements implemented in a system including an insulin injection device, processors, and processor-readable media storing instructions that cause performance of the recited excluding and calculating operations, the claims include significantly more than any alleged abstract idea", Examiner respectfully disagrees. Examiner described above that the instant claims do not describe any improvement to a computing system or components or technological field. In light of the Alice decision and the guidance provided in the 2019 PEG, the features listed in the claims, are not considered an improvement to another technology or technical field, or an improvement to the functioning of the computer itself. At best, these features may be considered to be an organizational issue solving managing medication dosing information, using computers. The alleged benefits that Applicants tout such as are due to administrative decisions, using computers, rather than any improvement to another technology or technical field, or an improvement to the functioning of the computer itself. By relying on computing devices to perform routine tasks more quickly or more accurately is insufficient to render a claim patent eligible (See Alice, 134 S. Ct. at 2359 "use of a computer to create electronic records, track multiple transactions, and issue simultaneous instructions" is not an inventive concept).
On page 11 of the remarks, Applicant argues “While the presently pending claims are directed to different subject matter than the claims of the parent application, they likewise recite a technological system involving an injection pen device and processor-executed operations that process physiological treatment data in order to generate insulin dose recommendations for administration using the injection pen device", Examiner respectfully disagrees. First, as noted in the Applicant remarks that the pending claims are directed to different subject matter that the claims of the parent applicant. Second, Examiner asserts that each non-provisional application is examined on its own merits, adhering to the requirements of 35 U.S.C. 101.
Therefore, the Applicant argument is found to be unpersuasive and Examiner remains the 101 rejections of claims which have been updated to address Applicant's argument.
Applicant's arguments with respect to the 35 U.S.C. § 103 rejection on page 8-11.
In response to the claim amendment and Applicant argument and remarks, Examiner with draws the prior art rejection under 35 U.S.C. 103 as described in the section “Subject Matter Free of Prior Art” above.
Conclusion
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 extension fee 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 date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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