DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Claim status
2. Claims 1-20 are currently pending and under exam herein.
Claims 1-20 are rejected.
Priority
3. This application is a continuation of U.S. Patent Application No. 16/150,643, filed October 3, 2018, now U.S. Patent No. 11,424,015, which is a continuation of U.S. Patent Application No. 14/039,758, filed September 27, 2013, now U.S. Patent No. 10,108,781, which claims priority to U.S. Provisional Application 61/707,593 filed September 28, 2012. Claimed benefit of domestic priority U.S. Provisional Application No. 61/707,593 filed September 28, 2012 is acknowledged. In this action, all claims are examined as though they had an effective filing date of September 28, 2012. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
4. The information disclosure statements (IDSs) submitted on 18 December 2022 (two IDSs)
2 March 2023, 10 May 2023, 15 September 2023, 29 November 2023, 30 January 2024, 20 March 2024 (two IDSs), 29 May 2024 (two IDSs), 9 July 2024, 26 September 2024, 1 November 2024 and 7 March 2025 are being considered by the examiner except for citations that are lined through because the citations could not be found.
Drawings
5. The drawing submitted on 22 August 2022 are accepted by the examiner.
Claim Objections
6. Claim 5 is objected to because of the following informalities: the claim recites “and second response rate is associated with a second corresponding time of treatment”, which is does not refer to an aforementioned response rate. One correction is to change the claim to read “and the second response rate is associated with a second corresponding time of treatment”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
7. Claims 1-20 are rejected under 35 U.S.C. 102(b) and 102(e) as being unpatentable over Wei et al. (US20110021898A1; published 27 January 2011). The italicized text corresponds to the instant claim limitations.
Regarding claims 1, 8 and 15, a method/system/device that reduces false alarms is interpreted to be one that affects a time delay for an alarm because it affects the frequency of alarm.
Regarding claims 1 and 8, Wei et al. disclose a method and system of controlling the alarms of a continuous glucose monitor to increase reliability of projected alarms and reduce false alarms. Wei et al. further discloses that the alarms are based on parameters relating to the collected patient data and that all predetermined parameters may be selectable by the patient or user (para. 0011; 0093; 0097-0101; a method [instructions for] of selecting or modifying a response rate of an analyte monitoring device).
Pertaining to claim 8, Wei et al. discloses that in accordance with the invention, there is provided an integrated glucose monitoring system, comprising a memory configured to store data relating to at least two measurements of a physiological glucose level in a patient; and at least one other medically relevant patient-specific data point of exogenous data, a user interface comprising a visual display, and a processor comprising computer-executable instructions to determine a rate of change between the at least two glucose level measurements and based on the determined rate of change, and perform various functions and processing related to data transmitted and received within the system. Wei et al. further discloses that the processor comprises a further computer-executable instruction to display information to the patient and a graphical user interface with an input device for communicating data and instructions from a patient to the processor. Wei et al. further discloses that the alarm comprises a visual alarm provided on the graphical user interface (para. 0011-0013; 0067; an analyte monitoring device, comprising: a processor; and memory operably coupled to the processor, wherein the memory includes instructions stored therein).
Regarding claim 15, Wei et al. discloses an analyte monitoring system including a sensor that is physically positioned on or in the body of a user whose analyte level is being monitored and the sensor is configured to continuously sample the analyte level of the user and convert the sampled analyte level into a corresponding data signal for transmission by the transmitter unit which can be physically coupled to the sensor. Wei et al. discloses that the transmitter unit performs data processing such as filtering and encoding on data signals, each of which corresponds to a sampled analyte level of the user, for transmission to the primary receiver unit via the communication link. Wei et al. further discloses that in connection with the receiver unit there is a data processing terminal/infusion section that may include, as examples, a personal computer, a portable computer such as a laptop or a handheld device (e.g., personal digital assistants (PDAs)), and the like, each of which may be configured for data communication with the receiver via a wired or a wireless connection. The data processing terminal/infusion section includes a processor that includes computer-executable instructions for performing various functions and processing related to, for example, data transmitted and received within the system, and one or more memory components configured to store data and computer executable instructions to do the analysis and control the alarm (Fig. 5; para. 0064-0067; 0075; 0080-0081; an analyte monitoring system comprising: a sensor electronics unit, comprising: a first processor and first memory operably coupled to the first processor; an in vivo analyte sensor operably coupled to the first processor; and a receiver configured to communicate with the sensor electronics unit, the receiver comprising: a second processor and second memory operably coupled to the second processor; wherein at least one of the first memory and second memory includes instructions stored therein [to perform the method]).
Regarding claims 1,8 and 15, Wei et al. further discloses that computer-executable instructions may be configured to provide an alarm if a difference between the expected glucose level and the target glucose level exceeds a preset warning value and the preset warning value may be established by the patient or a clinician and may be provided to the system through a graphical user interface of the display. Wei et al. further discloses that the alarm is based on profiles, which are based on continuous glucose monitor (CGM) data as well as exogenous data factors such as basal insulin level, carb ratio, insulin on board, prior carbohydrate intake, basal rate, available insulin bolus and insulin sensitivity. Wei et al. further disclose that the patient may review the profiles and change the current profile (for example by selecting a stored profile such as a ‘skip-meal’ profile) and command the processor to apply the stored profile’s attributes to management of the patients’ diabetes presently. Wei et al. further discloses that parameters that trigger an alarm can be adjusted to potentially reduce the incidence of false alarms, and/or make alarms more reliable, and that all predetermined parameters [that affect the false alarms/reliability of the alarm] can be defined by the patient or user. A profile that reduces the frequency of false alarms is one in which there is a time delay for an alarm. Wei et al. further discloses that information related to meals and insulin delivery may affect a projected alarm. For example, if a projected hyperglycemia alarm were about to occur, but information related to a recent insulin bolus delivery were provided, then the projected alarm may be desirably delayed as it may be unnecessary due to the effect that the recent bolus delivery will have. (para. 0012; 0018; 0031; 0081-0083; 0093-0105; the method/[analyte monitoring device]/[analyte monitoring system] comprising: receiving, with a processor, instructions for selecting a first response rate tailored to a first user; selecting or modifying, with the processor, the response rate of the analyte monitoring device to the first response rate; and operating the analyte monitoring device with the first response rate, wherein the first response rate comprises one or more of: a frequency at which data is displayed; an amount of averaging or smoothing of analyte measurement data; and a time delay for a warning or alarm).
Pertaining to claims 1, 8 and 15, Wei et al. discloses that the preset warning value may be established by the patient or a clinician and may be provided to the system through a graphical user interface of the display (para 0081; wherein the instructions are received externally via a user interface or a communication channel of the analyte monitoring device).
Pertaining to claims 2, 9 and 16, as indicated above, Wei et al. discloses that alarm reliability and false alarms are controlled by selecting profiles which are based on continuous glucose monitor (CGM) data as well as exogenous data factors such as basal insulin level, carb ratio, insulin on board, prior carbohydrate intake, basal rate, available insulin bolus and insulin sensitivity (para. 0012; 0018; 0081-0083; 0093-0105; the method of claim 1/[analyte monitoring device of claim 8]/[analyte monitoring system of claim 15], wherein the first response rate is tailored to physiological characteristics of the first user, the physiological characteristics comprising characteristics of the user's response to medicine or analyte absorption).
Pertaining to claims 3, 10 and 17, Wei et al. discloses that an example of the increased reliability of the predictive capability features when insulin delivery and meal information are taken into account include the following: if a projected low glucose alarm was about to occur but an insulin bolus was recently given, then the projected alarm may be initiated immediately instead of waiting for the previously scheduled time (para. 0033; the method of claim 1/[analyte monitoring device of claim 8]/[analyte monitoring system of claim 15], wherein the first response rate increases the response rate of the analyte monitoring device by one or more of: increasing the frequency at which the data is displayed; decreasing the amount of averaging or smoothing of the analyte measurement data; and decreasing the time delay for the warning or alarm).
Regarding claims 4, 11 and 18, Wei et al. discloses that information related to meals and insulin delivery (i.e. exogenous data) may affect a projected alarm. For example, if a projected hyperglycemia alarm were about to occur, but information related to a recent insulin bolus delivery were provided, then the projected alarm may be desirably delayed as it may be unnecessary due to the effect that the recent bolus delivery will have (para. 0031; the method of claim 1/[analyte monitoring device of claim 8]/[analyte monitoring system of claim 15], wherein the first response rate decreases the response rate of the analyte monitoring device by one or more of: decreasing the frequency at which the data is displayed; increasing the amount of averaging or smoothing of the analyte measurement data; and increasing the time delay for the warning or alarm).
Pertaining to claims 5 and 12, Wei et al. discloses that there are multiple stored profiles (including a basal profile and for example multiple different breakfast profiles). Wei et al. further discloses that profiles of CGM data may be provided for review and selection by the patient and that the patient may review the profiles and may retune one of more of the exogenous data in accordance with a processor's analysis of those profiles. For example, the patient may lower his or her basal rate to be consistent with the results of the profiles of the basal test (or select a stored profile similar to the present conditions) by making the change on a keyboard through programming of the processor or by use of a different user interface, such as the graphical user interface provided on the display. Wei et al. further discloses that in changing a profile, this also changes which conditions trigger an alarm; for example, an alarm may become more responsive with the additional inputs of meals and insulin (i.e. the alarm may occur sooner than if the inputs were absent) (para. 0068; 0102-0105; 0107-0109; 0083; the method of claim 1 [the analyte monitoring device of claim 8], further comprising: receiving, with the processor, instructions for selecting a second response rate tailored to the first user, wherein the instructions are received externally via the user interface or the communication channel of the analyte monitoring device, and wherein the first response rate is associated with a first corresponding time of treatment and second response rate is associated with a second corresponding time of treatment; selecting or modifying, with the processor, the response rate of the analyte monitoring device to the first response rate at the first corresponding time of treatment; operating the analyte monitoring device with the first response rate at the first corresponding time of treatment; selecting or modifying, with the processor, the response rate of the analyte monitoring device to the second response rate at the second corresponding time of treatment; and operating the analyte monitoring device with the second response rate at the second corresponding time of treatment; wherein the second response rate comprises one or more of: a second frequency at which data is displayed; a second amount of averaging or smoothing of analyte measurement data, and/or one or more second time delays for a warning or alarm.
Regarding claims 6 and 13, Wei et al. discloses that the metrics used for generating profiles (CGM data and exogenous data) are specific to the user. Therefore, there can be multiple different users with user-specific profiles that each have a different effect on the alarm delay. Specifically, Wei et al. discloses that system offers the ability to fine tune various glucose management factors to permit more accurate control of a patient's glucose levels and uses patient specific data including, basal rate of insulin delivery and a carb ratio that is determined for each patient based on the patient’s characteristics (which is used to calculate insulin amounts and calculations of carbohydrate amounts). Also, the individual patient's sensitivity to insulin or “correction factor” is determined and is used to calculate the speed with which insulin affects the patient, also a factor in determining when and how much insulin to deliver to that patient. Wei et al. further discloses that the device is for patients (plural) (para. 0041; the method of claim 1 [the analyte monitoring device of claim 8], further comprising: receiving, with the processor, instructions for selecting a second response rate tailored to a second user, wherein the instructions are received externally via the user interface or the communication channel of the analyte monitoring device; selecting or modifying, with the processor, the response rate of the analyte monitoring device to the second response rate; and operating the analyte monitoring device with the second response rate; wherein the second response rate comprises one or more of: a second frequency at which data is displayed; a second amount of averaging or smoothing of analyte measurement data, and/or one or more second time delays for a warning or alarm).
Pertaining to claims 7, 14 and 19, Wei et al. discloses that their invention is directed to a system and method for processing glucose level measurement data with exogenous data to result in more reliable projected alarms and to enable tuning of patient-specific insulin data. (para. 0010; the method of claim 1/ [analyte monitoring device of claim 8]/analyte monitoring system of claim 15], wherein the analyte is glucose).
Regarding claim 20, Wei et al. discloses that in some states, alarm decisions are based on the rate of change between two glucose level measurements and an alarm is sounded if the projected integrated glucose level for a third (future) measurement is outside of the stored safe range. Wei et al. further discloses that in another state (i.e. a more change resistant state), false alarms are reduced by basing the decision to sound an alarm on both the rate of change between two glucose level measurements and at least one or more of medically relevant datapoints (selected from the group of insulin on board, insulin sensitivity, prior carbohydrate intake, basal insulin, available insulin bolus; projection time, insulin action time, carbohydrate ratio, carbohydrate uptake time). Wei et al. further discloses that if the recommended change to one or more of the medically relevant datapoints has been performed before the third (future) timepoint, the alarm is not sounded. In this example, the first state is the system without the change to the medically relevant data point (i.e. change-resistant state is inactive) and the second state is the system with the change to the medically relevant data point (i.e. change resistant state is active) (para. 0014-0015; the analyte monitoring system of claim 15, wherein the instructions further comprise a change-resistant state that is either active or inactive, and wherein when the change-resistant state is active, analyte trend determinations are more resistant to changes in analyte levels obtained from the in vivo analyte sensor).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. Claims 1-5, 7-12 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 12-16 and 18-19, 23-26 and 29 of U.S. Patent No. US11424015B2 (reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are anticipated by the reference application as indicated in the table below. The table shows claims of the instant application that are taught by claims of the reference patent in the same row:
Instant application
US11424015B2 (reference)
Claim 1
Claims 1, (claim 3 or 4) and claim 7
Claim 2
Claim 2, (claim 3 or 4) and claim 7
Claim 3
Claims 3 and 7
Claim 4
Claims 4 and 7
Claim 5
Claims 5 and 7
Claim 7
Claim 6, (claim 3 or 4) and claim 7
Claim 8
Claim 12, (claim 14 or 15) and claim 19
Claim 9
Claim 13, (claim 14 or 15) and claim 19
Claim 10
Claims 14 and 19
Claim 11
Claims 15 and 19
Claim 12
Claim 16, (claim 14 or 15) and claim 19
Claim 14
Claim 18 (claim 14 or 15) and claim 19
Claim 15
Claim 23, (claims 25 or 26) and claim 29
Claim 16
Claim 24, (claims 25 or 26) and claim 29
Claim 17
Claims 25 and 29
Claim 18
Claims 26 and 29
Claim 19
Claim 27, (claims 25 or 26) and 29
Claim 20
Claim 28, (claims 25 or 26) and 29
This is a nonstatutory double patenting rejection.
Conclusion
9. No claims are allowed.
Claims 1-20 were analyzed under 35 U.S.C. 101 for patent eligibility and were found to be patent eligible at Step 2A prong 2, relating to an improvement integrating possible judicial exceptions into a practical application(see MPEP 2106). The improvement in this instance comprising: enabling external selection or modification to the system response rate of analyte monitoring-e.g., by a user, doctor, or other health care provider-to enable tailoring of the system response to an individual user's physiological characteristics or situation. In this way, the system response may be better matched to an individual user's characteristics or situation, thus allowing for more effective therapy, treatment, monitoring, etc., such as more effective medication rates, fewer false alarms, etc. (see specification, para. 0086).
E-mail Communications Authorization
10. Per updated USPTO Internet usage policies, Applicant and/or applicant's representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300): "Recognizing that Internet communications are not secure, / hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. / understand that a copy of these communications will be made of record in the application file."
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273- 8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER J SMITH whose telephone number is (571)272-7801. The examiner can normally be reached Monday-Friday 7:30 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.J.S./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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