DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed 2/4/26. Claims 38-52, and claims 79-83 are pending. Claims 79-83 are new.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/4/26 has been entered.
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 38-52 and 79-83 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 38-52 are drawn to a system; claims 79-80 are drawn to a method; claims 82-83 are drawn to an article of manufacture (product CRM storing instructions
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? If so, is the judicial exception integrated into a practical application of the judicial exception? A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” 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, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 38-52 recite(s) a method and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method and system are drawn to evaluating and outputting recommended medication dosing based upon received data (i.e. managing personal behavior or relationships)
In particular, claims 38, 79, and 82 recite a method for/ system configured to:
receive electronic signals indicating an analyte level of a user;
determine an analyte range that contains the analyte level;
reference a database to determine at least one medication dosage amount that was administered to the user when a measured analyte level was in the analyte range;
analyze the determined medication dosage amounts to identify patterns of medication effectiveness based on post-administration analyte responses;
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 38, 79, and 82 also recite an analyte sensor. As disclosed by the Wei reference, analyte sensors were well-known in the art at the time of filing. (par. 38) More specifically, Wei discloses: “A number of systems have been developed for the automatic monitoring of the analyte(s), like glucose, in bodily fluid such as in the blood stream, in interstitial fluid (“ISF”), dermal fluid of the dermal layer, or in other biological fluid. Some of these systems are configured so that at least a portion of a sensor is positioned below a skin surface of a user, e.g., in a blood vessel or in the subcutaneous tissue of a user, to obtain information about at least one analyte of the body… As such, these systems can be referred to as “in vivo” monitoring systems. In vivo analyte monitoring systems include “Continuous Analyte Monitoring” systems (or “Continuous Glucose Monitoring” systems) that can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule..” (par. 38-39)
Claims 38, 79, and 82 additionally recite: output at least a portion of the at least one medication dosage amount …with visual indicators distinguishing effective past medication dosages from ineffective past medication dosages for improving the user's ability to make informed medication dosing decisions.”. Claims 40, 42, 48 and 81 also recite additional steps including outputting or displaying information. The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. In the instant case the additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Claims 38, 79, and 82 recite one or more additional limitation(s), including “electronic system comprising: processing circuitry configured for processing data from an analyte sensor; and a non-transitory memory comprising a plurality of instructions….,” a database, and an electronic display. These additional components is/are generic components that perform functions well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “the processing of data and the execution of software within system 100 can be performed by one or more processors of reader device 120, computer system 170, and/or sensor control device 102. For example, raw data measured by sensor 104 can be algorithmically processed into a value that represents the analyte level and that is readily suitable for display to the user, and this can occur in sensor control device 102, reader device 120, or computer system 170. This and any other information derived from the raw data can be displayed in any of the manners described above (with respect to display 122) on any display residing on any of sensor control device 102, reader device 120, or computer system 170. " (par. 62) The disclosure also states: “As discussed above, reader device 120 can be a mobile communication device such as, for example, a WI-FI® or internet enabled smartphone, tablet, or personal digital assistant (PDA). Examples of smartphones can include, but are not limited to, those phones based on a WINDOWS® operating system, ANDROID® operating system, IPHONE® operating system, PALM WEBOS™, BLACKBERRY® operating system, or SYMBIAN™ operating system, with network connectivity for data communication over the internet or a local area network (LAN)..” (par. 63) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of the additional (generic) components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 38-52, and 79-83:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
- Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claims 39-52 are dependent from Claim 38 and include(s) all the limitations of claim(s) 38. However, the additional limitations of the claims 39-52 fail to recite significantly more than the abstract idea. More specifically, claims 39-52 recite additional limitations and steps which further define the abstract idea (e.g. describing details of the types of data; or additional steps, which do not integrate the abstract idea into a practical application.) Also, as explained previously, Claims 40, 42, and 48 also recite additional steps including outputting or displaying information. The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)).
Claims 80-81 are dependent from Claim 79 and include(s) all the limitations of claim(s) 79. However, the additional limitations of the claims 80-81 fail to recite significantly more than the abstract idea. More specifically, claims 80-81 recite additional limitations which further define the abstract idea (e.g. describing details of the types of data; or additional steps, which do not integrate the abstract idea into a practical application.) Also, as explained previously, Claim 81 also recite an additional step including outputting or displaying information.
Claim 83 are dependent from Claim 82 and include(s) all the limitations of claim(s) 82. However, the additional limitations of the claim 83 fail to recite significantly more than the abstract idea. More specifically, claims 83 recite additional limitations which further define the abstract idea (e.g. describing details of the types of data; or additional steps, which do not integrate the abstract idea into a practical application.)
Therefore, claim(s) 39-52 and 79-83 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 38-52 and 79-83 is/are rejected under 35 U.S.C. 103 as being obvious over Sieh (US 20100016700 A1) in view of Wei et al ( US 20180197628 A1), and in further view of Sloan et al (US 20120232520 A1)
Claims 38 Sieh teaches an electronic system configured to display past medication dosage information, the system comprising:
processing circuitry for processing data (i.e. from an analyte sensor) ; (Fig. 2, par. 43-an exemplary internal layout of analyte measurement device 100 is shown. Analyte measurement device 100 may include a processor 200, which in some embodiments described and illustrated herein is a 32-bit RISC microcontroller; Please note the source of the data i.e. from the analyte sensor does not alter the processing function of the processor, and does patentably distinguish the system processor from the prior art) and
a non-transitory memory comprising a plurality of instructions that, when executed, (par. 43-44) causes the processing circuitry to:
receive an analyte level of a user; (par. 46- Step 302 includes measuring an analyte with the analyte measurement device. In these embodiments, the analyte is measured using electrochemical techniques and the analyte is blood glucose. In other embodiments described and illustrated herein the analyte is measured photo metrically, and the analyte is blood glucose)
determine an analyte range that contains the analyte level; (par. 51-the method may further include calculating and displaying an analyte measurement average for a weekly, monthly, quarterly, yearly, or 6 week time period. Further, the method may further include calculating a percentage of out-of-range high and out-of-range low analyte measurements over a period of time, and displaying the percentage of out-of-range high and out-of-range low analyte measurements and time period. High and low ranges can be preset on the measurement device or set by the user or a health care practitioner, and are useful in managing conditions such as diabetes.)
reference a database to determine a plurality of medication dosage amounts that were administered to the user when a measured analyte level was in the analyte range; and (par. 10-outputting dosage information for therapeutic agent to be administered to a user based on one or multiple analyte amounts or concentration values stored in the memory; par. 46-Step 304 includes calculating a recommended therapeutic agent dosage and a recommended time for administration of the recommended therapeutic agent dosage based on the type of therapeutic agent, the most recent analyte measurement value, the time of the most recent analyte measurement, previous analyte measurement values, previous therapeutic agent dosages, and the time of previous therapeutic agent dosages.)
output at least a portion of the plurality of medication dosage amounts to an electronic display. (Fig. 3: 304,306, 308; par. 46- Additionally, the therapeutic agent is insulin and the analyte measurement is blood glucose. Step 306 includes displaying the recommended therapeutic agent dosage and recommended time for administration of the recommended therapeutic agent dosage on the display of the analyte measurement device.)
Claim 38 has been amended to further recite:
receive electronic signals indicating an analyte level of a user from the analvte sensor;
analyze the determined medication dosage amounts to identify patterns of medication effectiveness based on post-administration analyte responses; and output …with visual indicators distinguishing effective past medication dosages from ineffective past medication dosages for improving the user's ability to make informed medication dosing decisions.
Sieh discloses the method as explained but does not expressly disclose, but Wei teaches:
receiving electronic signals indicating an analyte level of a user from the/an analyte sensor (par. 39; 41-42; par. 48-50: sensor control device 102 can wirelessly communicate the collected analyte data (such as, for example, data corresponding to monitored analyte level and/or monitored temperature data, and/or stored historical analyte related data) to reader device 120 where, in certain embodiments, it can be algorithmically processed into data representative of the analyte level of the user and then displayed to the user and/or otherwise incorporated into a diabetes monitoring regime. In some embodiments, the algorithmic processing of the raw collected measurement data to arrive at data representative of the analyte level of the user and readily displayable (or made displayable) to the user is performed by the processing circuitry of sensor control device 102);
analyze the determined medication dosage amounts to identify patterns of medication effectiveness; (Fig. 17B-C; par. 237-238: The effect of different insulin bolus dosages to a given meal may be compared by using the GRR and coding (e.g., by color or pattern) the glucose traces for the insulin dosages as shown in FIG. 17B; par. 239- The effect of different meals on a patient's glucose response may be compared by using the GRR and coding the glucose traces (e.g., by color or pattern) for each menu item as shown in FIG. 17C.);
output …with visual indicators distinguishing effective past medication dosages from ineffective past medication dosages for improving the user's ability to make informed medication dosing decisions. (par. 130; par. 137: screen 428 includes a historical graphical display 406 of the user's analyte level with indicators 408 for each detected glucose excursion or meal event: par. 170, par. 193: when used with an analyte monitoring system 100, these embodiments can capture, categorize, and index glucose responses to the meals and meal-time insulin doses (administered to compensate for the meal) and thus provide the user with additional data from which the user's insulin dosages can be perfected or “fine-tuned.” In addition, over time, the example embodiments can provide recommendations as to the titration of the bolus amount for each meal; par. 238-239)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system of claim Sieh with teaching to include the additional features. One would have been motivated to include this features to help patients better understand how their own diet impacts their body's analyte response, and to allow the individual to compare and contrast their current and historical analyte data to see their how their own efforts are related to better diet and meal section and how these choices directly affect their health. (par. 14)
Claim 38 has been further amended to recite: analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window.
Sieh and Wei do not expressly disclose, but Sloan teaches analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window (par. 89-including current prescribed medication types and dosages and an algorithm for calculating recommended medication dosage changes. Calculated medication dosage recommendations may be displayed to the patient on the display unit 620 of the health monitor device 600 for patient intervention; par. 128-130: a predetermined dose adjustment amount may be added to the current dose level to give an adjusted dose level (2490) that is greater than the current dose level); par. 131; Table 2; par. 142).
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the method/system of Sieh and Wei in combination with the teaching of Sloan to include analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window. One would have been motivated to include this feature to provide a highly adaptive system method which can update patient medication regimens as needed, based upon the user’s personal response.
claim 39 Sieh teaches the system of claim 38, wherein the database comprises a plurality of medication dosage amounts paired with the measured analyte level of the user at or near a time of administration of each of the at least one medication dosage amount. (Fig. 3-4; fig. par. 46- Step 304 includes calculating a recommended therapeutic agent dosage and a recommended time for administration of the recommended therapeutic agent dosage based on the type of therapeutic agent, the most recent analyte measurement value, the time of the most recent analyte measurement, previous analyte measurement values, previous therapeutic agent dosages, and the time of previous therapeutic agent dosages. Additionally, the therapeutic agent is insulin and the analyte measurement is blood glucose. Step 306 includes displaying the recommended therapeutic agent dosage and recommended time for administration of the recommended therapeutic agent dosage on the display of the analyte measurement device; par. 51-52: retrieving a recommended therapeutic agent dosage and associated recommended administration time from the memory (also referred to herein as a memory module), and displaying such a retrieved recommended therapeutic agent dosage and administration time to user on the visual display of the analyte measurement device.)
claim 40 Sieh teaches the system of claim 38, wherein outputting the at least a portion of the at least one medication dosage amount comprises displaying the at least a portion of the at least one medication dosage amount. (par. 10- selecting one therapeutic administration protocol from the plurality of therapeutic administration protocols; and outputting dosage information for therapeutic agent to be administered to a user based on one or multiple analyte amounts or concentration values stored in the memory.)
claim 41 Sieh teaches the system of claim 38, wherein the plurality of instructions, when executed, further causes the processing circuitry to analyze the at least one medication dosage amount to determine a smallest dose, a largest dose, and a mode dose administered. (par. 50- Further, the recommended therapeutic agent dosage does not exceed a preset maximum daily dosage. For example, a maximum daily dosage of insulin may be entered into the analyte measurement device, and subsequently limit the daily recommended therapeutic agent dosage; par. 51- recording and analyzing dosages administered; reporting summary)
claim 42 Sieh teaches the system of claim 41, wherein the plurality of instructions, when executed, further causes the processing circuitry to display the smallest dose, the largest dose, and the mode dose. (Fig. 21-24; par. 88-90)
Claim 43. Sieh teaches the system of claim 38, wherein the plurality of instructions, when executed, further causes the processing circuitry to divide the least a portion of the at least one medication dosage amount into groups based on an association with a meal with which each of the at least a portion of the at least one medication dosage amount was administered. (fig. 15-tables Fig. 19; par. 70-75; par. 83-86- Where the protocol selected is the MDI protocol in screen 1902, the HCP would select the largest meal that the user would have during the day at screen 1907 and confirm at screen 1909 the regimen with the required dosages for rapid acting at specified daily event and rapid acting at a different daily event.)
Claim 44. Sieh teaches the system of claim 38, but does not expressly disclose wherein an upper and a lower boundary of the analyte range are selected from the group consisting of the analyte level +30%, the analyte level 25%, the analyte level +20%, the analyte level +15%, the analyte level +10%, and the analyte level +5%.
Wei teaches a system and method wherein the upper and lower boundary limits for an analyte range are selected from the group consisting of the analyte level +/- 30%, the analyte level +/- 25%, the analyte level +/- 20%, the analyte level +/- 15%, the analyte level +/- 10%, and the analyte level +/- 5%. (par. 94-95: the meal monitor software can default to a “medium” (or “normal” or “default”) mode using a group of predetermined settings or the settings input by the user. The meal monitor software can provide the option to switch to a different mode, such as a “low” mode or a “high” mode where the sensitivity or magnitude of the settings are scaled to be less likely or more likely, respectively, as compared to the “medium” mode, to consider a particular span of analyte data to qualify as a potential meal event. The “low” mode and “high” mode can each be a direct percentage scaling of the settings of the “medium” mode. For example, the “low” mode may use the settings of the “normal” mode adjusted by 5%, 10%, 15%, 20%, 25%, etc., so as to decrease the likelihood that a meal event is detected. Likewise, for example, the “high” mode may use the settings of the “normal” mode adjusted by 5%, 10%, 15%, 20%, 25%, etc., so as to increase the likelihood that a meal event is detected.) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the method/system of Sieh with the teaching Wei to include groupings/ranges for analyte levels to trigger resultant system recommendations (i.e. identification of meal events; recommendations for doses) One would have been motivated to include these features to make the system more adaptable, and to customize the system sensitivity. (par. 95-the meal monitor software application can provide the option for the user to scale the sensitivity of the meal event detector in an analog or virtual-analog fashion (at least from the user's perspective))
Claim 45 Sieh discloses the system of claim 38 as explained, but does not disclose wherein an upper and a lower boundary of the analyte range are selected from the group consisting of the analyte level + 50 mg/dL, the analyte level + 40 mg/dL, the analyte level + 30 mg/dL, the analyte level + 25 mg/dL, the analyte level +20 mg/dL, and the analyte level + 10 mg/dL.
Wei discloses a system wherein an upper and a lower boundary of the analyte range are selected from the group consisting of the analyte level + 50 mg/dL, the analyte level + 40 mg/dL, the analyte level + 30 mg/dL, the analyte level + 25 mg/dL, the analyte level +20 mg/dL, and the analyte level + 10 mg/dL.(par. 129-130- Screen 402 can include indications 404 and 406 of analyte levels determined from data received from analyte sensor 104 (not shown). Indication 404 is a numerical display of the user's current or last received analyte level (e.g. mg/dL). Indication 406 is a graphical display depicting a trace or curve of the user's analyte level (y axis) over time (x axis) against a shaded region 407 indicative of normal or desired analyte level range; par.,147-- a sum or integration of each glucose reading is determined from the meal start time to either a) the next meal start time, or b) when the glucose readings fall within a threshold value of the meal start glucose value (e.g., within 10 mg/dL), as it can be difficult to accurately assess where the glycemic response ends. This sum or integration value is proportional to the glucose multiplied by time area of the glucose response.)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the method/system of Sieh with the teaching Wei to include groupings/ranges for analyte levels to trigger resultant system recommendations (i.e. identification of meal events; recommendations for doses) One would have been motivated to include these features to make the system more adaptable, and to customize the system sensitivity. (par. 95-the meal monitor software application can provide the option for the user to scale the sensitivity of the meal event detector in an analog or virtual-analog fashion (at least from the user's perspective))
Claim 46 Sieh teaches the system of claim 38, wherein the at least one medication dosage amount is a plurality of medication dosage amounts, wherein the plurality of instructions, when executed, further causes the processing circuitry to: analyze the plurality of medication dosage amounts to order the plurality of medication dosage amounts according to the amount of each dose; and form first, second and third groups from the plurality of medication dosage amounts. (see fig. 7; fig. 15; par. 62-Method 700 may include steps 702, 704, 706, 708, and 710. Step 702 includes retrieving previous analyte measurement and therapeutic agent dosage results. In these embodiments, previous analyte measurement and therapeutic agent dosage results are retrieved from the analyte measurement device's memory, or from a removable memory that is coupled with the analyte measurement device. Step 704 includes determining if a user of the analyte measurement device has complied with recommended analyte measurements and a recommended administration protocol.)
Claim 47 Sieh teaches the system of claim 46, wherein the first group includes a smallest medication dosage administered to the user, the second group includes a largest medication dosage administered to the user, and the third group includes a median medication dosage administered to the user. (fig. 13-14; par. 70)
Claim 48. Sieh teaches system of claim 46, wherein the plurality of instructions, when executed, further causes the processing circuitry to: determine a mode dose for each of the first, second, and third groups, and display the mode dose for each of the first, second, and third groups. (fig. 13-14; par. 51-Reporting summaries are useful in accessing conformance to recommended protocols, and are particularly useful in communicating with health care practitioners. Further, the method may further include calculating and displaying an analyte measurement average for a weekly, monthly, quarterly, yearly, or 6 week time period. Further, the method may further include calculating a percentage of out-of-range high and out-of-range low analyte measurements over a period of time, and displaying the percentage of out-of-range high and out-of-range low analyte measurements and time period. High and low ranges can be preset on the measurement device or set by the user or a health care practitioner, and are useful in managing conditions such as diabetes; See also par. 70)
Claim 49 Sieh teaches the system of claim 38, wherein the plurality of instructions, when executed, further causes the processing circuitry to rate the at least one medication dosage amount.(Fig. 16; par. 71 -reevaluation of dosages and protocols based upon results, both short and long term)
Claim 50. Sieh teaches the system of claim 49, wherein each of the plurality of medication dosages are rated according to a proximity of a measured analyte level to a goal range after a period of time after administration of each of the at least one medication dosage amount. (Fig. 15-16; par. 71 -reevaluation of dosages and protocols based upon results, both short and long term)
Claim 51 Sieh teaches the system of claim 38, wherein the plurality of instructions, when executed, further causes the processing circuitry to associate a tag with at least a second portion of the at least one medication dosage amount. (Fig. 15-16; par. 71 -reevaluation of dosages and protocols based upon results, both short and long term)
Claim 52 Sieh teaches the system of claim 51, wherein the tag comprises details of a food, emotion, or activity associated with the at least a portion of the plurality of medication dosages. (Fig. 21-24; par. 87-88: At the option of the user, various screens can be generated to provide a summary of blood glucose test, trends, therapeutic type and dosage taken. In one example, as shown in screen 2003, a summary of the therapeutic agent and the type of therapeutic agent taken at a particular time and date is provided..
Claims 79 and 82 Sieh teaches a method for displaying past medication dosage information, and non-transitory computer-readable medium storing instructions that, when executed by processing circuitry (par. 43-44), cause the processing circuitry to perform operations comprising:
receiving, by processing circuitry, electronic signals indicating an analyte level of a user (par. 46- Step 302 includes measuring an analyte with the analyte measurement device. In these embodiments, the analyte is measured using electrochemical techniques and the analyte is blood glucose. In other embodiments described and illustrated herein the analyte is measured photo metrically, and the analyte is blood glucose);
determining an analyte range that contains the analyte level; (par. 51-the method may further include calculating and displaying an analyte measurement average for a weekly, monthly, quarterly, yearly, or 6 week time period. Further, the method may further include calculating a percentage of out-of-range high and out-of-range low analyte measurements over a period of time, and displaying the percentage of out-of-range high and out-of-range low analyte measurements and time period. High and low ranges can be preset on the measurement device or set by the user or a health care practitioner, and are useful in managing conditions such as diabetes.)
referencing a database to determine a plurality of medication dosage amounts that were administered to the user when a measured analyte level was in the analyte range; (par. 10-outputting dosage information for therapeutic agent to be administered to a user based on one or multiple analyte amounts or concentration values stored in the memory; par. 46-Step 304 includes calculating a recommended therapeutic agent dosage and a recommended time for administration of the recommended therapeutic agent dosage based on the type of therapeutic agent, the most recent analyte measurement value, the time of the most recent analyte measurement, previous analyte measurement values, previous therapeutic agent dosages, and the time of previous therapeutic agent dosages.)
outputting at least a portion of the plurality of medication dosage amounts to an electronic display (Fig. 3: 304,306, 308; par. 46- Additionally, the therapeutic agent is insulin and the analyte measurement is blood glucose. Step 306 includes displaying the recommended therapeutic agent dosage and recommended time for administration of the recommended therapeutic agent dosage on the display of the analyte measurement device.).
Claim 79 further recites:
receiving electronic signals indicating an analyte level of a user from the analyte sensor;
analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window; and
outputting … with visual indicators distinguishing effective past medication dosages from ineffective past medication dosages for improving the user's ability to make informed medication dosing decisions.
Sieh discloses the method as explained but does not expressly disclose, but Wei teaches:
receiving electronic signals indicating an analyte level of a user from the/an analyte sensor (par. 39; 41-42; par. 48-50: sensor control device 102 can wirelessly communicate the collected analyte data (such as, for example, data corresponding to monitored analyte level and/or monitored temperature data, and/or stored historical analyte related data) to reader device 120 where, in certain embodiments, it can be algorithmically processed into data representative of the analyte level of the user and then displayed to the user and/or otherwise incorporated into a diabetes monitoring regime. In some embodiments, the algorithmic processing of the raw collected measurement data to arrive at data representative of the analyte level of the user and readily displayable (or made displayable) to the user is performed by the processing circuitry of sensor control device 102);
output … with visual indicators distinguishing effective past medication dosages from ineffective past medication dosages for improving the user's ability to make informed medication dosing decisions. (par. 130; par. 137: screen 428 includes a historical graphical display 406 of the user's analyte level with indicators 408 for each detected glucose excursion or meal event: par. 170, par. 193: when used with an analyte monitoring system 100, these embodiments can capture, categorize, and index glucose responses to the meals and meal-time insulin doses (administered to compensate for the meal) and thus provide the user with additional data from which the user's insulin dosages can be perfected or “fine-tuned.” In addition, over time, the example embodiments can provide recommendations as to the titration of the bolus amount for each meal; par. 238-239)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system of claim Sieh with teaching to include the additional features. One would have been motivated to include this features to help patients better understand how their own diet impacts their body's analyte response, and to allow the individual to compare and contrast their current and historical analyte data to see their how their own efforts are related to better diet and meal section and how these choices directly affect their health. (par. 14)
Claims 79 and 82 further recite: analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window.
Sieh and Wei do not expressly disclose, but Sloan teaches analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window (par. 89-including current prescribed medication types and dosages and an algorithm for calculating recommended medication dosage changes. Calculated medication dosage recommendations may be displayed to the patient on the display unit 620 of the health monitor device 600 for patient intervention; par. 128-130: a predetermined dose adjustment amount may be added to the current dose level to give an adjusted dose level (2490) that is greater than the current dose level); par. 131; Table 2; par. 142).
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the method/system of Sieh and Wei in combination with the teaching of Sloan to include analyzing the plurality of medication dosage amounts to identify patterns of medication effectiveness based on a change in analyte level measured by the analyte sensor occurring after administration of each medication dosage amount within a defined post-administration time window. One would have been motivated to include this feature to provide a highly adaptive system method which can update patient medication regimens as needed, based upon the user’s personal response.
Claims 80 and 83 Sieh teaches the method/product of claims 79 and 82, wherein the database comprises a plurality of medication dosage amounts paired with the measured analyte level of the user at or near a time of administration of each of the plurality of medication dosage amounts. (Fig. 3-4; fig. par. 46- Step 304 includes calculating a recommended therapeutic agent dosage and a recommended time for administration of the recommended therapeutic agent dosage based on the type of therapeutic agent, the most recent analyte measurement value, the time of the most recent analyte measurement, previous analyte measurement values, previous therapeutic agent dosages, and the time of previous therapeutic agent dosages. Additionally, the therapeutic agent is insulin and the analyte measurement is blood glucose. Step 306 includes displaying the recommended therapeutic agent dosage and recommended time for administration of the recommended therapeutic agent dosage on the display of the analyte measurement device; par. 51-52: retrieving a recommended therapeutic agent dosage and associated recommended administration time from the memory (also referred to herein as a memory module), and displaying such a retrieved recommended therapeutic agent dosage and administration time to user on the visual display of the analyte measurement device.)
Claim 81 Sieh teaches the method of claim 79, wherein outputting at least a portion of the plurality of medication dosage amounts comprises displaying the at least a portion of the plurality of medication dosage amounts. (par. 10- selecting one therapeutic administration protocol from the plurality of therapeutic administration protocols; and outputting dosage information for therapeutic agent to be administered to a user based on one or multiple analyte amounts or concentration values stored in the memory.)
Response to Arguments
Applicant's arguments filed 2/4/26 have been fully considered but they are not persuasive.
(A) Applicant argues the rejections of the claims under 35 USC 101. Specifically, applicant argues that the claims are not directed to an abstract idea, and that claim 38 does not recite an abstract idea, but rather a specific technological solution to a technological problem in diabetes management.
In response, the examiner disagrees. The claimed method and system are drawn to certain method of organizing human behavior. In particular, the claims are drawn to evaluating and outputting recommended medication dosing based upon received data (i.e. managing personal behavior or relationships).
Consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.(See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology.
However, it is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019) Note, there is no requirement for the judicial exception to provide the improvement.
In the instant case, applicant’s apparent improvement is to method of tracking, and suggesting dosages for analyte for a patient, not an improvement to the underlying technology.
(B) Applicant argues that the claims cannot be performed in the human mind.
In response, the mental process analysis of the rejection under 35 USC 101 has been withdrawn, because the system/method detects information using an analyte sensor.
(C) Applicant argues that the claims integrate any recited abstract idea into a practical application.
The examiner respectfully disagrees. The recited judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While applicant argues that the claims determine medication effectiveness, the claimed invention does not recite that this is performed (by the system). The claimed invention recites an outputting step (e.g. display) with visual indicators. However, it is not clear from the claimed invention that assessment is drawn from a system analysis (i.e. vs data that is logged by a user)
(D) Applicant argues that the prior art references do not teach the claims as amended.
In response, the examiner has provided new grounds of rejection to address the amended language of claim 38, and newly added claims 79-83.
(E) Applicant argues that the prior art does not disclose “visual indicators” regarding dose efficacy.
In response, the examiner disagrees. The claim limitations recite that the display includes visual indicators of effective and ineffective dosages, in the output step. Moreover, In response to applicant's argument that regarding the details of the visual display, the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684