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 .
Response to Amendment
The amendment filed on 12/16/2025 has been entered. Claims 1-20 are pending in the application. Claims 17-20 are new. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 9/17/2025.
Claim Objections
Claim 12 is objected to because of the following informalities:
-Claim 12, lines 1-2: please correct “the predetermined duration of time” to “the duration of time”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the countdown timer" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the countdown timer” as “a countdown timer for the duration of time”
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 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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-11, and 13-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rosinko et al. (US 2022/0184309 A1).
Regarding claim 1, Rosinko discloses a system (see Figs. 1A-C) comprising:
an implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) configured to deliver a therapy to a patient according to a therapy-delivery regimen (see par. [0094]-[0100]); and
an external device (external electronic device 108) configured to wirelessly transmit, to the implantable medical device (AMD 100), a programming update (see Fig. 7, par. [0097]-[0099], [0128]-[0129]), a timeout module, and a command instructing the implantable medical device (AMD 100) to cease a delivery of the therapy while installing the programming update (see Fig. 9, par. [0144]-[0149], [0259]-[0260]), wherein, upon a failure of the implantable medical device (AMD 100) to restart the delivery of the therapy after a duration of time indicated by the timeout module, the implantable medical device (AMD 100) is configured to output an alert indicating that the implantable medical device (AMD 100) has failed to restart (see par. [0149], [0259]-[0260], [0284]-[0285]).
Regarding claim 2, Rosinko discloses the system of claim 1, wherein the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) comprises an infusion pump (see par. [0094]-[0100]).
Regarding claim 3, Rosinko discloses the system of claim 1, wherein the programming update comprises a software update for the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) or a modification for the therapy-delivery regimen (see Fig. 9, par. [0128]-[0129], [0144]-[0149]).
Regarding claim 4, Rosinko discloses the system of claim 1, wherein the alert comprises an auditory signal, a tactile signal, or a visual signal (see par. [0285] and [0354]).
Regarding claim 5, Rosinko discloses the system of claim 1, wherein the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) is configured to wirelessly transmit the alert to the external device (external electronic device 108) (see Fig. 7, par. [0128]-[0129], [0285]).
Regarding claim 7, Rosinko discloses an implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) comprising processing circuitry configured to:
deliver a therapy to a patient according to a therapy-delivery regimen (see par. [0094]-[0100]);
wirelessly receive a programming update (see Fig. 7, par. [0097]-[0099], [0128]-[0129]) comprising a command instructing the implantable medical device (AMD 100) to cease delivery of the therapy during installation of the programming update (see Fig. 9, par. [0144]-[0149], [0259]-[0260]);
wirelessly receive a duration of time for a countdown timer (see par. [0128]-[0129], [0149], [0259]-[0260], [0284]-[0285]);
install the programming update and initiate the countdown timer for the duration of time (see Fig. 9, par. [0128]-[0129], [0149], [0259]-[0260], [0284]-[0285]); and
in response to failing to automatically restart the delivery of the therapy upon expiration of the duration of time, generate and output an alert to notify a user that the implantable medical device (AMD 100) has failed to restart (see par. [0149], [0259]-[0260], [0284]-[0285]).
Regarding claim 8, Rosinko discloses the implantable medical device of claim 7, wherein the processing circuitry is configured to terminate the countdown timer upon restarting the delivery of the therapy according to the therapy-delivery regimen (see par. [0284]-[0285]).
Regarding claim 9, Rosinko discloses the implantable medical device of claim 7, wherein the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) comprises an infusion pump (see par. [0094]-[0100]).
Regarding claim 10, Rosinko discloses the implantable medical device of claim 7, wherein the programming update is configured to update software of the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) or modify the therapy-delivery regimen (see Fig. 9, par. [0128]-[0129], [0144]-[0149]).
Regarding claim 11, Rosinko discloses the implantable medical device of claim 7, wherein the alert comprises an auditory signal, a tactile signal, or a visual signal (see par. [0285] and [0354]).
Regarding claim 13, Rosinko discloses a method (see Figs. 1A-C, 7, and 9) comprising:
receiving, by an implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]), a programming update comprising a command instructing the implantable medical device (AMD 100) to cease a delivery of a therapy during installation of the programming update (see Figs. 1A-C, 7, and 9, par. [0094]-[0100], [0144]-[0149], [0259]-[0260]);
receiving, by the implantable medical device (AMD 100), a duration of time comprising an amount of time needed for receipt and processing of the programming update and subsequent restarting of the delivery of the therapy (see par. [0128]-[0129], [0149], [0259]-[0260], [0284]-[0285]);
commencing, by the implantable medical device (AMD 100), the installation of the programming update (see Fig. 9, par. [0144]-[0149]);
upon commencing the installation of the programming update, initiating a countdown timer for the duration of time (see Fig. 9, par. [0128]-[0129], [0149], [0259]-[0260], [0284]-[0285]);
determining a failure to restart the delivery of the therapy upon expiration of the duration of time (see par. [0149], [0259]-[0260], [0284]-[0285]); and
outputting, by the implantable medical device (AMD 100), an alert to notify a user that the implantable medical device (AMD 100) has failed to restart the delivery of the therapy (see par. [0149], [0259]-[0260], [0284]-[0285]).
Regarding claim 14, Rosinko discloses the method of claim 13, further comprising, upon restarting the delivery of the therapy, terminating, by the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]), the countdown timer (see par. [0284]-[0285]).
Regarding claim 15, Rosinko discloses the method of claim 13, wherein the alert comprises an auditory signal, a tactile signal, or a visual signal (see par. [0285] and [0354]).
Regarding claim 16, Rosinko discloses the method of claim 13, wherein the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) comprises an infusion pump (see par. [0094]-[0100]).
Regarding claim 17, Rosinko discloses the system of claim 1, wherein, upon the failure of the implantable medical device (AMD 100) to restart the delivery of the therapy after the duration of time, the implantable medical device (AMD 100) is configured to revert to a previous therapy-delivery schedule (see par. [0285], step 2712).
Regarding claim 18, Rosinko discloses the system of claim 1, wherein, upon the failure of the implantable medical device (AMD 100) to restart the delivery of the therapy after the duration of time, the implantable medical device (AMD 100) is configured to automatically log the failure to identify a gap in delivered therapy (see par. [0285], the alert can be considered logging the failure to identify the gap).
Regarding claim 19, Rosinko discloses the system of claim 1, wherein the duration of time comprises an amount of time needed for receipt and processing of the programming update and subsequent restarting of the therapy (see par. [0144]-[0145], [0149], [0259]-[0260], [0284]-[0285]).
Regarding claim 20, Rosinko discloses the system of claim 1, wherein the implantable medical device (AMD 100) is configured to reset the countdown timer upon a reinitiation of the wireless transmission (see par. [0144]-[0145], [0149], the process repeats/resets each time an update is necessary).
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 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Rosinko et al. (US 2022/0184309 A1), as applied to claims 1 and 7 above.
Regarding claim 6, Rosinko discloses the system of claim 1. However, Rosinko fails to expressly state wherein the duration of time comprises about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, or about 30 minutes.
Rosinko discloses that an alert message is generated after a duration of time passes in which the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]-[0097]) has failed to restart (see par. [0285]). The specific duration of time selected is a result effective variable in that changing the duration of time alters how quickly the user will be informed and be able to remedy unsafe conditions of the implantable medical device (see par. [0285]), which reduces disruption of care resulting from software updates (see par. [0136]). Further, it appears that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the system of Rosinko to have a duration of time within the claimed range, as it involves adjusting a software parameter capable of being adjusted. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rosinko such that the duration of time comprises about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, or about 30 minutes as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, Applicant appears to place no criticality on the range claimed, stating that "in some examples" the duration of time is within the claimed range (see Specification par. [0010]).
Regarding claim 12, Rosinko discloses the implantable medical device of claim 7. However, Rosinko fails to expressly state wherein the predetermined duration of time comprises about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, or about 30 minutes.
Rosinko discloses that an alert message is generated after a predetermined duration of time passes in which the implantable medical device (ambulatory medical pump device AMD 100 has portions which are implanted, see Figs. 1A-C, par. [0095]- [0097]) has failed to restart (see par. [0285]). The specific predetermined duration of time selected is a result effective variable in that changing the predetermined duration of time alters how quickly the user will be informed and be able to remedy unsafe conditions of the implantable medical device (see par. [0285]), which reduces disruption of care resulting from software updates (see par. [0136]). Further, it appears that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the implantable medical device of Rosinko to have a predetermined duration of time within the claimed range, as it involves adjusting a software parameter capable of being adjusted. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable medical device of Rosinko such that the predetermined duration of time comprises about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, or about 30 minutes as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, Applicant appears to place no criticality on the range claimed, stating that "in some examples" the predetermined duration of time is within the claimed range (see Specification par. [0010]).
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
In regards to claim 1, Applicant argues that Rosinko teaches away from the claimed invention. Specifically, Applicant states that Rosinko’s invention is configured to install updates between therapy sessions and therefore does not teach a timeout module and a command instructing the implantable medical device to cease a delivery of the therapy while installing the programming update as recited in the claim. This argument is not found to be persuasive. While Rosinko does state that “it is desirable to prevent disruption to therapy during the application update process” (Rosinko, par. [0148]), Rosinko also states “In some cases, a time when the application can be installed without interrupting therapy may not be identified…The user may be provided with an option as to whether to permit the update and/or when to install the application update. The option may include presenting the user with the estimated install time enabling the user to schedule the application update at a time when interruptions to therapy may be minimal…” (Rosinko, par. [0149]). In other words, Rosinko teaches that while it is preferable to install updates without delaying therapy, this is not always possible. When it is not possible to install updates without delaying therapy, the user is notified and given an estimated install time such that the user can approve the interruption to therapy at a convenient time. Thus, the user can use the external device to command the medical device to suspend therapy to install the update for a period of time based on the estimated install time (Rosinko, par. [0149], [0259]-[0260]). If, after the estimated install/suspension time passes and the therapy is not resumed, the user is alerted (Rosinko, par. [0284]-[0285]). Therefore, the Examiner interprets that Rosinko still teaches each and every limitation of the claim.
Applicant further states that Rosinko fails to teach the limitations of claims 7 and 13 which are substantially similar to those previously argued regarding claim 1. For the same reasons described above and in the rejections of claims 7 and 13, the Examiner interprets that Rosinko still teaches each and every limitation of the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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