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 .
Status of Claims
This action is in reply to the pre-appeal request filed on 07/15/25.
Claim 151 has been amended and is hereby entered.
Claims 178-180 have been added.
Claims 14-17, 148 have been canceled.
Claims 1-13, 18-147, 149-150, 160-161, 163, 165-167, 171-177 were previously canceled.
Claims 151-159, 162, 164, 168-170, 178-180 are currently pending and have been examined.
This action is made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 151-159, 162, 164, 168-170, 178-180 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 151, as amended, recites “determining, by the at least one processor, a glucose variability of the subject, a risk of hypoglycemia, and a recommended adjustment to an insulin dose based on at least one of the potential cause inputted, a type of episode, and a time of day, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high”, which appears to constitute new matter. In particular, Applicant does not point to, nor was Examiner able to find, support for this newly added language within the specification as originally filed. The specification nor the publications incorporated by reference appear to disclose the claimed subject matter.
Specifically, Claim 151, as amended, recites in part, “wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high”. In remarks dated 02/07/25, at page 6 as printed, Applicant cites to US Publication 20130085358A1 (herein after “the ‘358 publication”), incorporated by reference, as providing support for this limitation, specifically, paras. [0032] and [0059], reprinted below, and Figs. 12-19; Applicant specifically cites to Fig. 17 as providing support for the amendment (page 9 as printed).
Examiner respectfully disagrees that the ‘358 publication provides support for the amended claim language. Fig. 17 only indicates that if the median glucose is above target post-breakfast and the hypoglycemia risk is low, to increase an insulin breakfast dosage. Examiner submits that “post-breakfast” is narrower than “after a meal” as recited by instant Claim 151. The ‘358 publication does not provide support for the concept of when the median glucose is above target “post lunch” or “post dinner” and the hypoglycemia risk is low, to increase the insulin dosage. Similarly, Fig. 17 only indicates that if the median glucose is above a target glucose median after lunch or after dinner (both of which are narrower than “after a meal” as recited by instant Claim 151) and variability is high, to either make no adjustment to the dosage or decrease the dosage if variability cannot be reduced. These recommended actions of either making no adjustment to the dosage or decreasing the dose if variability cannot be reduced, post-lunch or post-dinner, are different than what is actually being claimed in instant Claim 151. Figure 17 does not indicate that if “post breakfast” median glucose is above a target and variability is high, the recommended adjustment to insulin dosage is to decrease the insulin dose. Fig. 17, nor any of the other figures in the ‘358 publication, provide support for the broader claim language of Claim 151.
Regarding paragraphs cited by Applicant in the ‘358 publication:
Para. [0032] discloses: ”In one embodiment, a database stores recommendations and corresponding conditions that are associated with or required by the recommendations. For example, a table may include predetermined conditions that are associated with one or more recommendations. Based on the conditions that exist, the appropriate recommendation may be determined. In some instances, the conditions and requirements may take into account attributes of the episodes themselves—e.g., type of episode, specific combinations of episodes present, number of episodes, relation to event or activities (e.g., meals, fasting periods, exercise, medication administration, times of day (e.g., morning, afternoon, night, sleeping periods, etc.), etc. Based on the resulting attributes of episodes found for the measurement data, the associated recommendations in the database will be selected.”
Para. [0059] discloses: “The core logic of episode analysis falls into two families: threshold based, and rate-of-change based thresholds. Looking for episodes in both directions, for example, suggests four basic episode types: low glucose/hypoglycemia (measurements below a threshold); high glucose/hyperglycemia (measurements above a threshold); glucose fall (rate-of-change more negative than a negative threshold rate); and glucose rise (rate-of-change more positive than a positive threshold rate). In one embodiment, a “within target” episode is defined to identify an episode where the measurements are maintained between an upper and lower bound for a period of time. Detection of these episodes can be done by extension of the threshold-based episode detection algorithms”.
Regarding Fig. 17, para. [0037] discloses, “FIG. 17 illustrates recommendations provided along with the option for the user to select the corresponding course of action. In the example shown, the recommendations are provided for medication adjustment purposes. For instance, a summary A10 of the health related parameters are listed for different event periods—e.g., median glucose and glucose variability are provided fasting periods to indicate that these are the areas of concern determined for this period. The user interface provides the user with suggested or recommended courses of action A11. For example, as shown for fasting, the user is presented with the option of reducing variability with no medication dose adjustment; or the option of decreasing the medication adjustment if variability cannot be reduced”.
Examiner respectfully submits that paras. [0032], [0037] and [0059] fail to provide support for instant claim 151’s recitation of “determining, by the at least one processor, a glucose variability of the subject, a risk of hypoglycemia, and a recommended adjustment to an insulin dose based on at least one of the potential cause inputted, a type of episode, and a time of day, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high.”
Claim 151 also recites, “generating, by the at least one processor, a second graphical user interface (GUI) and at least one report accessible through the second GUI that is related to the analyte information from the first and second time periods and includes a count of a number of times the potential cause of each of the detected one or more analyte episodes was inputted by the subject for at least a subset of the detected one or more analyte episodes and the recommended adjustment to the insulin dose; and administering, using an insulin delivery device, the recommended adjustment to the insulin dose”, which also constitute new matter. As discussed above, the instant specification/publications incorporated by reference do not provide support for the prior limitation pertaining to the step of how the recommended adjustment to insulin is determined. Accordingly, the step of generating a GUI that includes the recommended adjustment to the insulin dose, “wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high” does not have support. Similarly, the limitation of administering, using an insulin delivery device, the recommended adjustment to the insulin dose, “wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high”, does not have support. As discussed above, the instant specification and publications incorporated by reference lack support for how the recommended adjustment to the insulin dose is determined. Subsequently, these limitations pertaining to generating a GUI that includes the recommended adjustment to the insulin dose and administering, using an insulin delivery dose, the recommended adjustment to the insulin dose, lack support because the determination step to arrive at the recommended adjustment to the insulin dose to be displayed via GUI and administered, as currently claimed, is not supported.
The specification discloses:
[0049] Reader device 120 can also include or be integrated with a drug (e.g., insulin, etc.)
delivery device such that they, e.g., share a common housing. The drug delivery hardware can
include a reservoir to store the drug and a pump that can be connectable to transfer tubing and an infusion cannula for administering the drug from the reservoir, through the tubing and into the
diabetic’s body by way of the cannula inserted therein.
This only discloses that a drug (insulin) delivery device may be integrated into a reader device. It generally discloses that an infusion cannula may be used for administering insulin into a patient’s body. There is no disclosure of using an insulin delivery device to administer a recommended adjustment to the insulin dosage, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high.
The specification further discloses:
[0205] At 2504, the HCP and diabetic or other caregiver can review the collected data and establish or adjust medication (e.g., insulin) therapy, such as with the aid of a GPI report 1900. At 2506, appropriate goals and thresholds can be set within the EIS by the user (the HCP, caregiver, or diabetic) to enable the production of the various reports (e.g., a median threshold goal in the GPI report) and to detect episodes and excursions (e.g., low glucose threshold, high glucose threshold, rapid rise threshold, to name a few). At 2508, the EIS can be activated and the diabetic can monitor his or her glucose with reader device 120 operating the EIS (or a glucose monitoring software and the EIS) for a first time period (e.g., a number of days or weeks). The EIS can be set to operate at only certain times of the day, such as those that have shown to be problematic in the baseline data.
[0206] At 2510, a session can be held between the HCP and the diabetic or caregiver to review the data collected by the EIS over that first time period. This can include review of one or more reports capable of generation by the EIS. For example, the episode response report 2200 can be generated and the most frequent episode cause or causes can be identified. The daily graphs 1806 within the episode response report 2200 can be then be used to identify the specific underlying behavior causing the episodes. Other reports can be utilized based on the specific situation.
[0207] At 2512, the HCP can discuss a realistic modification to behavior to address the cause, and optionally develop an action plan to assist in the behavior modification. At 2514, any requisite adjustment to medication therapy can be identified and implemented, for example, with the assistance of the GPI report 1900. This process can be repeated as necessary until the diabetic's variability levels and/or excursions are reduced to the desired levels.
This only discloses that a healthcare provider (HCP) can review various types of data collected over a time period to establish or adjust insulin based on the collected data. In particular, [0205] discloses “the HCP and diabetic or other caregiver can review the collected data and establish or adjust medication (e.g., insulin) therapy, such as with the aid of a GPI report 1900” and [0207] discloses “any requisite adjustment to medication therapy can be identified and implemented, for example, with the assistance of the GPI report 1900”. This does not provide support for generating a GUI which includes the recommended adjustment to the insulin dosage and administering, using an insulin delivery device, the recommended adjustment to the insulin dose, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high.
Examiner further notes the following paragraphs of specification:
[0316] There has been interest in the use of expert systems or machine learning (referred to collectively herein as “expert systems”) to analyze data of diabetes patients and generate therapy recommendations therefrom. For example, an architecture with expert system capabilities has been proposed (e.g., Medtronic and IBM Watson collaboration) where the architecture can have access to various types of data provided by patients (e.g., insulin pump delivery systems, glucose monitoring systems), along with access to other data (e.g., meal logs, activity monitors, heart rate monitors, location) to discover or learn correlative patterns that can be exploited to provide a personalized system that detects potential problems and warns or guides patients into actions that can prevent the problem from occurring.
This only discloses that expert systems may analyze diabetic patient data, in which the patient data may be obtained by insulin pump delivery system, to learn patterns in order to provide therapy recommendations. There is no disclosure of using an insulin delivery device to administer a recommended adjustment to the insulin dosage, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high.
Examiner respectfully submits that different parts of different publications cannot be piecemealed together; support must be present in applications incorporated by reference for the same analysis and same recommendation as the analysis and recommendation as the instant invention. Performing a different analysis than the instant invention to output a recommendation does not adequately provide support for the instant invention.
Dependent claims 152-159, 162, 164, 168-170, 178-180 inherit the deficiencies of parent Claim 151 and are subsequently rejected.
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
35 USC 112(a) Rejections
Applicant’s remarks regarding the rejection of Claim 151 under 35 USC 112(a) have been fully considered but are not persuasive. As explained above in the 112(a) section, the instant specification only appears to provide support for determining a recommended adjustment to an insulin dosage, and does not provide support for the specific way of determining the recommended adjustment to the insulin dose as claimed. There is no disclosure of actually delivering the recommended adjusted dosage to the patient, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high.
Regarding Applicant’s citation to para. [0006] of US Publication 20140188400, incorporated by reference, Examiner respectfully disagrees that this provides adequate disclosure to provide support for the limitation administering, using an insulin delivery device, the recommended adjustment to the patient, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high.
Para. [0006] in its entirety discloses:
For example, analyte monitoring and medication delivery devices are commonly used in the treatment of a patient. One or more samples of analytes from the patient's body tissues are sensed and data is accumulated. A monitor, containing a sensor and a processor, may be used to acquire, accumulate, and process that data. Ultimately a report must be produced from that data and an analysis made by an HCP. In response to the analysis, one or more medications may be administered to the patient or other course of treatment prescribed, such as exercise and control over the timing, amount, and contents of meals. Administration of the medication may be manual by the patient such as self-injection with a syringe, by another person such as a nurse, or by a powered medication administration device, such as an infusion pump, for automatic or continuous delivery. For example, glucose monitors and insulin pumps are commonly used in the treatment and management of type 1 diabetes mellitus.
Examiner respectfully submits that this paragraph broadly discusses how insulin may be delivered to a patient via self-injection with a syringe, by another person or by a device such as an infusion pump/insulin pump (e.g., delivery device). Para. [0006] discloses that an analysis of collected patient data is “made by a HCP” (healthcare provider). This paragraph does not support administering, using an insulin delivery device, a recommended adjustment to the insulin dose, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high, as required by Claim 151.
Regarding Applicant’s remarks to US Publication 20130085358A1, also incorporated by reference, please see 112(a) Rejection section above which discusses this reference in-depth and why it is insufficient to provide support for the amended limitation “determining, by the at least one processor, a glucose variability of the subject, a risk of hypoglycemia, and a recommended adjustment to an insulin dose based on at least one of the potential cause inputted, a type of episode, and a time of day, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high”, and the subsequent steps of generating a GUI which includes the recommended adjustment and delivering, using an insulin delivery device, the recommended adjustment to the insulin dose. As explained above in 112(a) Rejection section above, the ‘358 publication is narrower than the instant application and does not provide support for the broader claimed subject matter of Claim 151.
The rejections of Claims 151-159, 162, 164, 168-170, 178-180 under 35 USC 112(a) are maintained.
35 USC 101 Rejections
The rejections of claims 151-159, 162, 164, 168-170 under 35 USC 101 are withdrawn in view of Applicant’s amendments and remarks dated 02/07/25. As amended, Claim 151 recites “determining, by the at least one processor, a glucose variability of the subject, a risk of hypoglycemia, and a recommended adjustment to an insulin dose based on at least one of the potential cause inputted, a type of episode, and a time of day, wherein, if a median glucose is above a target glucose median after a meal, the recommended adjustment to the insulin dose is to (1) increase the insulin dose if a risk of hypoglycemia is low, and (2) decrease the insulin dose if the glucose variability is high” and “administering, using an insulin delivery device, the recommended adjustment to the insulin dose”, which amounts to a practical application of the abstract idea (see prior correspondence, e.g., Non-Final action dated 08/16/24, Final Action dated 02/22/24) at Step 2A Prong 2 by effecting a particular treatment.
MPEP 2106.04(d)(2) (“Particular Treatment and Prophylaxis”) discusses examples of effecting a particular treatment for a disease or medical condition to integrate a judicial exception into a practical application. In particular, MPEP 2106.04(d)(2)(a) discusses an example of a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications, and states “This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application.” Similarly, the instant claim recites an analysis of patient-specific data to determine a recommended amount of insulin to be delivered, e.g., the amount of insulin should be increased or decreased depending on whether the patient’s risk to hypoglycemia is low or if glucose variability is high when the patient’s median glucose is above a target glucose median after a meal. The instant claim also recites a particular administration step of that administering, via an insulin delivery device, the recommended dosage (increased or decreased, depending on patient’s specific data). Therefore, Claims 151-159, 162, 164, 168-170, 178-180 are subject matter eligible.
Conclusion
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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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682