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
Applicant has amended claims 1-20.
All previous claim objections and indefinite claim limitations have been overcome and are withdrawn.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nekoomaram et al. (US 20100313105, henceforth Nekoomaram, previously made of record).
Regarding claim 1, Nekoomaram discloses a method for selectively enabling features of an insulin pump (device 201 which includes a pump as in [0057] for insulin as in [0057]) enabled by a software package (update of [0057], the method comprising: receiving, by the insulin pump having storage (first memory of [0039]) and a processor (microprocessor of [0039]) and adapted to deliver insulin to a user ([0057]), the software package from a remote device or a mobile device (computing device 202, [0042]), the software package comprising updated software ([0022]) configured to be used by a plurality of insulin pumps (see [0035] and [0119], the update can be for multiple devices with different serial numbers), the updated software comprising computer-executable instructions that, when executed by the insulin pump, enable a pump function (see [0057], the update includes instructions for the pump to deliver expected insulin boluses); writing the software package to the storage to save the software package locally on the insulin pump (see [0055]); determining that the pump function is incompatible with the insulin pump (see [0041], compatibility checking is a part of the process); and determining not to enable the pump function corresponding to the computer- executable instructions based on determining that the pump function is incompatible with the insulin pump (see [0057], failure of proper installation causes the pump to not deliver which is a result of the pump function being activated), rendering the pump function inoperable on the insulin pump while the software package remains saved locally on the insulin pump (see [0057], [0058] and [0041], the pump device 201 which is not properly updated with the critical update is inoperable during the reset while the pump self-restores to the previous version, and the critical update remains stored in a separate area of the memory from the backup version).
Regarding claim 2, Nekoomaram discloses the method of claim 1 wherein determining that the pump function is incompatible with the insulin pump is based on at least one of user data, pump data, medical history data, training data, or pump use data (see [0084] and [0085], compatibility tables are used to determine compatibility and use pump data such as serial numbers to determine compatibility and incompatibility).
Regarding claim 5, Nekoomaram discloses the method of claim 2 further comprising determining that the pump function is compatible with the insulin pump based on at least one of updated user data, updated pump data, updated medical history data, updated training data, or updated pump use data (see [0084] and [0085], compatibility tables are used to determine compatibility and use updated pump data such as serial numbers for the newest critical update).
Regarding claim 3, Nekoomaram discloses the method of claim 1 further comprising: determining that a set time period has elapsed since determining that the pump function is incompatible with the insulin pump (this is the amount of time required for a reset, and since a failed critical update triggers a reset, the claim requirements are met once the reset has occurred as in [0051]-[0053]); and determining, after determining that the set time period has elapsed, that the pump function is compatible with the insulin pump (see [0051]-[0053], the reset allows for resumed operability and the pump function is operable again due to its compatibility with previous software versions).
Regarding claim 4, Nekoomaram discloses the method of claim 3 further comprising: enabling the pump function on the insulin pump; and executing the computer-executable instructions to perform the pump function (successful critical updates allow for proper pumping and insulin delivery, see [0057] and [0061]).
Regarding claim 6, Nekoomaram discloses the method of claim 1 further comprising: receiving an enablement command to enable the pump function on the insulin pump from the mobile device or the remote device (see [0061], the pump is commanded by device 201 which receives its instructions from computing device 202 as in [0042]); enabling the pump function on the insulin pump (see [0061]); and executing the computer-executable instructions to perform the pump function (see [0061]).
Regarding claim 7, Nekoomaram discloses the method of claim 1 further comprising: receiving an enablement command instructions to enable the pump function on the insulin pump from an external device different from the mobile device and the remote device (see [0061], the pump is commanded by device 201 which receives its instructions from server 203 in an alternative method as disclosed in [0041]); enabling the pump function on the insulin pump (see [0061]); and executing the computer-executable instructions to perform the pump function (see [0061]).
Regarding claim 8, Nekoomaram discloses a method for selectively enabling features of an insulin pump (device 201 which includes a pump as in [0057] for insulin as in [0057]) enabled by a software package (update of [0057]), the method comprising: receiving, by a user device, the software package from a remote device (see [0041] and [0066], server 203 which is the first device sends the update to pump device 201 via remote computing device 202), the software package comprising updated software ([0022]) configured to be used by a plurality of insulin pumps (see [0035] and [0119], the update can be for multiple devices with different serial numbers), the updated software comprising computer-executable instructions that, when executed by the insulin pump, enable a pump function on the insulin pump (see [0057], the update includes instructions for the pump to deliver expected insulin boluses), the insulin pump adapted to deliver insulin to a user ([0057]); sending the software package to the insulin pump to be saved locally on the insulin pump (see [0055]); determining that the pump function is incompatible with the insulin pump (see [0041], compatibility checking is a part of the process); and sending a disable instruction to the insulin pump to cause the insulin pump not to enable the pump function corresponding to the computer-executable instructions based on determining that the pump function is incompatible with the insulin pump (see [0057], failure of proper installation causes the pump to not deliver which is a result of the pump function being activated), rendering the pump function inoperable on the insulin pump while the software package remains saved locally on the insulin pump (see [0057], [0058] and [0041], the pump device 201 which is not properly updated with the critical update is inoperable during the reset while the pump self-restores to the previous version, and the critical update remains stored in a separate area of the memory from the backup version).
Regarding claim 9, Nekoomaram discloses the method of claim 8 wherein the user device comprises storage (first memory, [0039]), memory (second memory, [0040]), and a processor microprocessor of [0039], and the method further comprising writing the software package to the storage or the memory of the user device to save the software package locally on the user device (see [0055], the saving occurs locally in the first memory which is the storage as claimed).
Regarding claim 10, Nekoomaram discloses the method of claim 8 further comprising determining a user record corresponding to the insulin pump, the user record comprising user data, pump data, medical history data, training data, or pump use data (see [0084] and [0085], compatibility tables are used to determine compatibility and use pump data such as serial numbers to determine compatibility and incompatibility).
Regarding claim 11, Nekoomaram discloses the method of claim 10 wherein determining that the pump function is incompatible with the insulin pump is based on the user data, pump data, medical history data, training data, or pump use data (see [0084] and [0085], compatibility tables are used to determine compatibility and use pump data such as serial numbers to determine compatibility and incompatibility).
Regarding claim 12, Nekoomaram discloses the method of claim 10 further comprising: determining that a set time period has elapsed since determining that the pump function is incompatible with the insulin pump (this is the amount of time required for a reset, and since a failed critical update triggers a reset, the claim requirements are met once the reset has occurred as in [0051]-[0053]); and determining, after determining the set time period has elapsed, that the pump function is compatible with the insulin pump (see [0051]-[0053], the reset allows for resumed operability and the pump function is operable again due to its compatibility with previous software versions).
Regarding claim 13, Nekoomaram discloses the method of claim 12 wherein determining that the pump function is compatible with the insulin pump comprises determining the pump function is compatible with updated user data, updated pump data, updated medical history data, updated training data, or updated pump use data associated with the user record (see [0051]-[0053], after the reset is complete, the pump data is updated such that the version number of the software goes back to the last compatible software allowing the device to function again).
Regarding claim 14, Nekoomaram discloses the method of claim 10 further comprising causing the insulin pump to enable the pump function corresponding to the computer-executable instruction, based on determining that the pump function is compatible with the insulin pump (successful critical updates based on proper compatibility allow for proper pumping and insulin delivery, see [0057] and [0061]).
Regarding claim 15, Nekoomaram discloses the method of claim 8 further comprising receiving a first response from the remote device indicative of the insulin pump being incompatible with the pump function, wherein determining that the pump function is incompatible with the insulin pump is based on the first response (see [0067], the pump device 201 sends an identifier to the remote device 202 which can relay the information to the server 203).
Regarding claim 16, Nekoomaram discloses the method of claim 8 further comprising receiving a second response from an external device different from the remote device (see [0101], a compatibility table can be looked up externally by a person to allow for transmission of the proper critical update), the second response indicative of the insulin pump being incompatible with the pump function (see [0101], compatibility and incompatibility is determined from the lookup table from the external reference), wherein determining that the pump function is incompatible with the insulin pump is based on the second response (see [0101]).
Regarding claim 17, Nekoomaram discloses a method for selectively enabling features of an insulin pump (device 201 which includes a pump as in [0057] for insulin as in [0057]) enabled by a software package (update of [0057]), the method comprising: obtaining, by a remote device, the software package (see [0041] and [0066], server 203 which is the first device sends the update to pump device 201 via remote computing device 202) comprising updated software configured to be used by a plurality of insulin pumps (see [0035], [0057], and [0119], the update can be for multiple devices with different serial numbers), the updated software comprising; computer-executable instructions that, when executed by the insulin pump, enable a pump function on the insulin pump (see [0057], the update includes instructions for the pump to deliver expected insulin boluses), the insulin pump adapted to deliver insulin to a user ([0057]); sending, by the remote device, the software package to a user device associated with the insulin pump or to the insulin pump, to be saved locally on the insulin pump (see [0041], [0055], and [0066], server 203 which is the first device sends the update to pump device 201 via remote computing device 202); determining that the pump function is incompatible with the insulin pump (see [0041], compatibility checking is a part of the process); and sending a disable instruction to the user device or the insulin pump to cause the insulin pump not to enable the pump function corresponding to the computer- executable instructions based on determining that the pump function is incompatible with the insulin pump (see [0057], failure of proper installation causes the pump to not deliver which is a result of the pump function being activated), rendering the pump function inoperable on the insulin pump while the software package remains saved locally on the insulin pump (see [0057], [0058] and [0041], the pump device 201 which is not properly updated with the critical update is inoperable during the reset while the pump self-restores to the previous version, and the critical update remains stored in a separate area of the memory from the backup version).
Regarding claim 18, Nekoomaram discloses the method of claim 17 further comprising determining a user record corresponding to the insulin pump, the user record comprising user data, pump data, medical history data, training data, or pump use data (see [0084] and [0085], compatibility tables are used to determine compatibility and use pump data such as serial numbers to determine compatibility and incompatibility).
Regarding claim 19, Nekoomaram discloses the method of claim 18 wherein determining that the pump function is incompatible with the insulin pump is based on the user data, pump data, medical history data, training data, or pump use data (see [0084] and [0085], compatibility tables are used to determine compatibility and use pump data such as serial numbers to determine compatibility and incompatibility).
Regarding claim 20, Nekoomaram discloses the method of claim 19 further comprising: determining that a set time period has elapsed since determining that the pump function is incompatible with the insulin pump (this is the amount of time required for a reset, and since a failed critical update triggers a reset, the claim requirements are met once the reset has occurred as in [0051]-[0053]); and determining, after determining the set time period has elapsed, that the pump function is compatible with the insulin pump based on updated user data, updated pump data, updated medical history data, updated training data, or updated pump use associated with the user record (see [0051]-[0053], after the reset is complete, the pump data is updated such that the version number of the software goes back to the last compatible software allowing the device to function again).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 8, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783