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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 April 2026 has been entered.
Formal Matters
Applicant's response, filed 07 April 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 16-35 are currently pending and have been examined.
Claims 16, 27, 29, and 35 have been amended.
Claims 16-35 have been rejected.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed for Application No. EP20315453.9, filed on 22 September 2023.
The instant application therefore claims the benefit of priority under 35 U.S.C 119(a)-(d). Accordingly, the effective filing date for the instant application is 17 November 2020 claiming benefit to EP20315453.9.
Claim Interpretation
Claims 16, 27, 29, and 35 recite a titration process. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Here, the term “a titration process” in claims 16, 27, 29, and 35 are not explicitly defined in the specification or the claims. However, the specification alludes to the titration process being the any generic dose adjustments known in the art specific for medication dose management machines (see the disclosure on p. 20 lines 29-34 and in Fig 5). Examiner therefore interprets the titration process to be consistent with and limited to adjusting a dosage of a medication generally and not within the scope of a wet laboratory titration for concentrating or diluting a chemical via reacting the chemical with a solution of known concentration.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-22 and 24-35 are rejected under 35 U.S.C. 103 as being unpatentable over Hoglund et al. (US Patent Application No. 2017/0091419)[hereinafter Hoglund] in view of Hoar (US Patent Application No 2021/0241905)[hereinafter Hoar] in further view of Runyon et al. (US Patent Application No. 2018/0294053)[hereinafter Runyon].
As per claim 16, Hoglund teaches on the following limitations of the claim:
a computing device comprising a memory and a processing arrangement, the memory storing instructions which, when executed by the processing arrangement, cause the computing device to is taught in the Detailed Description in ¶ 0011, ¶ 0013, ¶ 0021, and ¶ 0023-25 (teaching on a computer device with a memory and processor programed to monitor and adjust a medication dosage from patient lifestyle and biometric data)
a second wireless communication link with a fitness tracking device is taught in the Detailed Description in ¶ 0015, ¶ 0035, in the Figures at fig. 1A ref char 100 and 105, and fig. 2 (teaching on receiving lifestyle information for the patient from an activity tracking device over a network)
receive, via the first communication link, dose information comprising a previous dose ejected by the injection device is taught in the Detailed Description in ¶ 0017, ¶ 0059, and ¶ 0064 (teaching on receiving past dosage information at "past time" (Tp) for the patient from a medical device wherein the device may be a medication pump (treated as synonymous to an injection device))
determine a measure of wellbeing for a patient based on received wellbeing data is taught in the Detailed Description in ¶ 0045, ¶ 0051 and ¶ 0064 (teaching on receiving lifestyle data wherein the lifestyle information includes emotional wellness data (consistent with the instant specification's definition of wellbeing data on p. 16 line 26- p. 17 line 7) wherein the lifestyle data is utilized to generate a patient health metric)
determine at least one of: a measure of fitness for the patient based on physiological data received from the fitness tracking device via the second wireless communication link; or is taught in the Detailed Description in ¶ 0015, ¶ 0048, and ¶ 0059 (teaching on receiving lifestyle information for the patient wherein the lifestyle information includes patient activity (treated as synonymous to a measure of fitness) based on physiological data during activity from an activity tracking device)
a measure of bodyweight for the patient based on weight data is taught in the Detailed Description in ¶ 0050 and ¶ 0062 (teaching on the patient vital data including the patient's current weight)
determine an adjusted medicament dose, the determination being performed as part of a titration process and based at least in part on the dose information, the measure of wellbeing, and the at least one of the measure of fitness or the measure of bodyweight; and is taught in the Detailed Description in ¶ 0074 and ¶ 0064 (teaching on determining a new dosage recommendation (treated as synonymous to a titration process consistent with the instant application - see the claim interpretation section for further detail) based on the lifestyle data received wherein the lifestyle data includes the historical dosages, patient activity data, and emotional wellness data)
transmit a control signal indicative of the adjusted medicament dose is taught in the Detailed Description in ¶ 0074-75 (teaching on transmitting a signal to display the dosage recommendation to the user on a user interface)
Hoglund fails to teach the following limitation of claim 16. Hoar, however, does teach the following:
establish a first wireless communication link with an injection device and a second wireless communication link with a fitness tracking device is taught in the Detailed Description in ¶ 0052, ¶ 0054, ¶ 0063, in the Figures in fig. 1 ref char 14, 5, and 100 (teaching on a medication injection device connected over a network to a central disease management processors)
transmit a control signal indicative of the adjusted medicament dose to the injection device to cause the injection device to be automatically dialled a dose value corresponding to the adjusted medicament dose is taught in the Detailed Description in ¶ 0063 (teaching on automatically injecting a dose by an injection device based on the treatment recommendation output)
It would have been obvious to one of ordinary skill in the art at the time of the invention to have a smart insulin pump to deliver the determined medicament dosage as in the improvement discussed in Hoar in the system executing the medicament dosage prediction method of Hoglund. As in Hoar, it is within the capabilities of one of ordinary skill in the art to enable the automatic delivery of the medicament to the dosage recommendation with the predicted result of delivering medication according the determined dosage as needed in Hoglund.
Hoglund and Hoar fails to teach the following limitation of claim 16. Runyon, however, does teach the following:
received from a balance is taught in the Detailed Description in ¶ 0027-28 and ¶ 0031 (teaching on receiving weight data from a wireless scale)
One of ordinary skill in the art before the effective filing date would combine the medication dosage modification system of Hoglund and Hoar with the smart scale transmitting weight data to the system of Runyon with the motivation of “allow[ing] the mobile device to track body weight over time” (Runyon in the Detailed Description in ¶ 0031) and “provide real time weight tracking and step counting” (Runyon in the Detailed Description in ¶ 0070).
Independent claims 27, 29, and 35 are rejected under the same rational.
As per claim 17, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the instructions, when executed by the processing arrangement, further cause the device to output at least the wellbeing data and the dose information comprising the previous dose to a server arrangement for storage is taught in the Detailed Description in ¶ 0027-28, ¶ 0062, and ¶ 0071 (teaching on storing current and historical dosage recommendations and corresponding input data in a cloud computing storage)
As per claim 18, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the physiological data comprises pulse data and wherein the instructions, when executed by the processing arrangement, cause the device to determine the measure of fitness based on the pulse data is taught in the Detailed Description in ¶ 0048 (teaching on physiological data during activity including distance traveled, blood pressure, and heart rate data (treated as synonymous to pulse data))
As per claim 19, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the physiological data comprises blood pressure data and wherein the instructions, when executed by the processing arrangement, cause the device to determine the measure of fitness based on the blood pressure data is taught in the Detailed Description in ¶ 0048 (teaching on physiological data during activity including distance traveled, blood pressure, and heart rate data (treated as synonymous to pulse data))
As per claim 20, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the physiological data comprises step count data and wherein the instructions, when executed by the processing arrangement, cause the device to determine the measure of fitness based on the step count data is taught in the Detailed Description in ¶ 0048 (teaching on physiological data during activity including distance traveled (Examiner notes travel distance is directly related to step count), blood pressure, and heart rate data (treated as synonymous to pulse data))
Hoglund fails to teach the following; Runyon, however, does disclose:
step count data is taught in the Detailed Description in ¶ 0030 (teaching on receiving steps taken when measuring a fitness activity)
One of ordinary skill in the art before the effective filing date would combine the medication dosage modification system of Hoglund and Hoar with the step count as a measure of fitness of Runyon since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably measuring activity by a user.
As per claim 21, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the instructions, when executed by the processing arrangement, further cause the device to: output at least one of the measure of wellbeing, the measure of fitness, or the measure of bodyweight for display is taught in the Detailed Description in ¶ 0019 and ¶ 0075 (teaching on displaying to the user on the user display the historical metrics received for determining the dosage recommendation)
As per claim 22, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 21. Hoglund also discloses the following:
the device according to claim 21, wherein the at least one of the measure of wellbeing, the measure of fitness, or the measure of bodyweight for display are displayed along with one or more previous measures of wellbeing, measures of fitness, or measures of bodyweight is taught in the Detailed Description in ¶ 0019 and ¶ 0075 (teaching on displaying to the user on the user display the historical metrics received for determining the dosage recommendation)
As per claim 24, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund fails to teach the following; Runyon, however, does disclose:
the device according to claim 16, wherein the instructions, when executed by the processing arrangement, further cause the device to: determine whether the measure of fitness meets a first predetermined threshold is taught in the Detailed Description in ¶ 0049-50 (teaching on receiving steps taken when measuring a fitness activity and determining that a measure of fitness, here a step count, meets a predetermined threshold)
determine whether the measure of bodyweight meets a second predetermined threshold; and is taught in the Detailed Description in ¶ 0058 (teaching on receiving the user's current weight and comparing to a weight loss goal threshold to determine if a milestone has been met)
in response to determining that the measure of fitness meets the first predetermined threshold or that the measure of bodyweight meets the second predetermined threshold, output a virtual award for display at the device is taught in the Detailed Description in ¶ 0056-58, in the Figures in fig. 7, and fig. 13 (teaching on displaying either a SmartLoss or a Milestone positive feedback banner (treated as synonymous to a virtual reward) based on either the step count meeting the threshold or the weight loss goal)
One of ordinary skill in the art before the effective filing date would combine the medication dosage modification system of Hoglund and Hoar with milestone thresholds for digital award displays of Runyon with the motivation of “combin[ing] diet, exercise, and behavior modification in a manner that is easy to use and that promotes long term sustainable weight loss” (Runyon in the Background in ¶ 0004).
As per claim 25, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the instructions, when executed by the processing arrangement, further cause the device to receive food intake information input by a user and store the received food intake information is taught in the Detailed Description in ¶ 0049 and ¶ 0063 (teaching on receiving lifestyle information wherein the lifestyle information includes food or drink ingestion data from a user input and storing said lifestyle data)
As per claim 26, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund fails to teach the following; Runyon, however, does disclose:
the device according to claim 16, wherein the instructions, when executed by the processing arrangement, further cause the device to publish data corresponding to at least one of the measure of wellbeing, the measure of fitness, or the measure of bodyweight to a social media platform is taught in the Detailed Description in ¶ 0068-69 (teaching on publishing to social media weight loss reports including that day's performance flag (treated as synonymous to the measure of fitness) or the total weight loss (treated as synonymous to the measure of bodyweight)).
One of ordinary skill in the art before the effective filing date would combine the medication dosage modification system of Hoglund and Hoar with social media posting of Runyon with the motivation of “combin[ing] diet, exercise, and behavior modification in a manner that is easy to use and that promotes long term sustainable weight loss” (Runyon in the Background in ¶ 0004) by allowing users to “share weight loss progress in social media” (Runyon in the Figure Description in ¶ 0024).
As per claim 28, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 27. Hoglund also discloses the following:
the system according to claim 27, further comprising an injection device configured to transmit dose information to the device, wherein the device is configured to determine the adjusted medicament dose based at least in part on the dose information is taught in the Detailed Description in ¶ 0017, ¶ 0059, and ¶ 0064 (teaching on receiving past dosage information at "past time" (Tp) for the patient from a medical device wherein the device may be a medication pump (treated as synonymous to an injection device))
As per claim 30, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 29. Hoglund also discloses the following:
the method of claim 29, further comprising: causing the device to output at least the wellbeing data and the dose information comprising the previous dose to a server arrangement for storage is taught in the Detailed Description in ¶ 0027-28, ¶ 0062, and ¶ 0071 (teaching on storing current and historical dosage recommendations and corresponding input data in a cloud computing storage)
As per claim 31, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 29. Hoglund also discloses the following:
the method of claim 29, wherein the physiological data comprises pulse data and wherein the method further comprises causing the device to determine the measure of fitness based on the pulse data is taught in the Detailed Description in ¶ 0048 (teaching on physiological data during activity including distance traveled, blood pressure, and heart rate data (treated as synonymous to pulse data))
As per claim 32, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 29. Hoglund also discloses the following:
the method of claim 29, wherein the physiological data comprises blood pressure data and wherein the method further comprises causing the device to determine the measure of fitness based on the blood pressure data is taught in the Detailed Description in ¶ 0048 (teaching on physiological data during activity including distance traveled, blood pressure, and heart rate data (treated as synonymous to pulse data))
As per claim 33, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 29. Hoglund also discloses the following:
the method of claim 29, wherein the physiological data comprises step count data and wherein the method further comprises causing the device to determine the measure of fitness based on the step count data is taught in the Detailed Description in ¶ 0048 (teaching on physiological data during activity including distance traveled (Examiner notes travel distance is directly related to step count), blood pressure, and heart rate data (treated as synonymous to pulse data))
Hoglund fails to teach the following; Runyon, however, does disclose:
step count data is taught in the Detailed Description in ¶ 0030 (teaching on receiving steps taken when measuring a fitness activity)
One of ordinary skill in the art before the effective filing date would combine the medication dosage modification system of Hoglund and Hoar with the step count as a measure of fitness of Runyon since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably measuring activity by a user.
As per claim 34, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 29. Hoglund also discloses the following:
the method of claim 29, further comprises causing the device to output at least one of the measure of wellbeing, the measure of fitness, or the measure of bodyweight for display is taught in the Detailed Description in ¶ 0019 and ¶ 0075 (teaching on displaying to the user on the user display the historical metrics received for determining the dosage recommendation)
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hoglund et al. (US Patent Application No. 2017/0091419)[hereinafter Hoglund] in view of Hoar (US Patent Application No 2021/0241905)[hereinafter Hoar] in further view of Runyon et al. (US Patent Application No. 2018/0294053)[hereinafter Runyon] in further view of Meltzer et al. (US Patent Application No. 2014/0357961)[hereinafter Meltzer].
As per claim 23, the combination of Hoglund, Hoar, and Runyon discloses all of the limitations of claim 16. Hoglund also discloses the following:
the device according to claim 16, wherein the instructions, when executed by the processing arrangement, further cause the device to: receive side effect data indicative of one or more side effects experienced by the patient; and determine the adjusted medicament dose based at least in part on the side effect data is taught in the Detailed Description in ¶ 0071 (teaching on receiving from the user outcome states from taking the recommended medication dosage (treated as synonymous with a side effect)).
The combination of Hoglund, Hoar, and Runyon fails to explicitly teach the following; Meltzer, however, does disclose:
receive side effect data is taught in the Detailed Description in ¶ 0053 (teaching on the patient feedback being experienced side effects explicitly).
One of ordinary skill in the art before the effective filing date would combine the medication dosage modification system of Hoglund, Hoar, and Runyon with the explicitly side effect reporting of Meltzer since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably reporting medication outcomes which one of ordinary skill would recognize includes side effects.
Response to Arguments
Applicant's arguments filed 07 April 2026 with respect to 35 USC § 101 have been fully considered and are persuasive. The § 101 rejection of claims 16-35 has been withdrawn as the claims positively recite a practical application via a prophylaxis step under MPEP § 2106.04(d)(2).
Applicant’s arguments filed 07 April 2026 with respect to 35 USC § 103 have been considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Hoar, as per the rejection above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
J. Youssef et al., A Review of Closed-Loop Algorithms for Glycemic Control in the Treatment of Type 1 Diabetes, 2 Algorithms 518-532 (March 12, 2009) teaching on review of insulin dispensing devices connected to a central processor in the § 2. History of Closed Loop Systems on p. 521 and Figure 1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JORDAN LYNN JACKSON whose telephone number is (571)272-5389. The examiner can normally be reached Monday-Friday 8:30AM-4:30PM ET.
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/JORDAN L JACKSON/Primary Examiner, Art Unit 2857
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