Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim 1 is amended.
Claims 5-20 are new.
Claims 1-20 are examined in this office action.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
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).
Claims 1-3, 5-7, 9-10, 11-13. 15-17, 19-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moberg (US Patent No. 6362591) in view of Mounce et al. (US Pub No. 20080077081 A1).
Regarding claim 1, Moberg discloses a method of controlling a portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) comprising:
sensing that a drive system (drive motor 111, Fig. 2) of a portable infusion pump system (Fig. 2) is damaged (“… detecting an occlusion or drive system failure in a medication infusion system …” – Abstract) via a drive system detector (“… occlusion detector …” – Para [3])
in response to the sensing that the drive system detector indicates the drive system is damaged (Is current > Baseline + K? 508, Fig. 5), disabling the drive system housed in the portable infusion pump system (Stop Pump 509, Fig. 5).
Moberg does not expressly disclose including an electrically conductive element that extends along a piston rod of the drive system of the portable infusion system.
Mounce teaches including an electrically conductive element (“… U-shaped nut 114 may be made of or otherwise include a magnetic material…” – Para [0098]) that extends along a piston rod (“… the piston shaft is composed of a pair of rods 40a and 40b …” – Para [0094], Fig. 7A) of the drive system of the portable infusion system (“The rods 40a and 40b provide a rigid connection between a U-shaped nut 114 and the plunger 34.” – Para [0094], Fig. 7A)
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include including an electrically conductive element that extends along a piston rod of the drive system of the portable infusion system as taught by Mounce in order to further detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 2, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, further comprising
in response to the sensing that drive system detector indicates said drive system is damaged (Is current > Baseline + K? 508, Fig. 5), emitting an audible alarm (Provide alarm indication 510, Fig. 5) (“Should there be an occlusion … an audible, tactile, and/or display alarm typically is triggered.” – Para [15])
Regarding claim 3, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, further comprising
in response to the sensing that the drive system detector indicates said drive system is damaged (Is current > Baseline + K? 508, Fig. 5), displaying one or more alert text messages (Provide alarm indication 510, Fig. 5) (“Should there be an occlusion … an audible, tactile, and/or display alarm typically is triggered.” – Para [15]) on a user interface display of the portable infusion pump system (display panel 115, Fig. 1)
Examiner interprets a display alarm to include text messages.
Regarding claim 5, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the sensing that the drive system of the portable infusion pump system is damaged via the drive system detector, comprises:
receiving an electrical signal (Measure Current 507, Fig. 5) indicating an electrical connection with the drive system detector has been interrupted (Is Current > Baseline + K? 508, Fig. 5), wherein receiving the electrical signal indicates the drive system is damaged (“… if the measured motor current is some amount greater than a known, average baseline motor current … then it is determined that an occlusion condition has likely occurred.” – Para [23]).
Moberg does not expressly disclose the electrically conductive element.
Mounce teaches the electrically conductive element ("… U-shaped nut 114 may be made of or otherwise include a magnetic material …" - Para [0098]).
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include the electrically conductive element as taught by Mounce in order to further detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 6, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the sensing that the drive system of the portable infusion pump system is damaged via the drive system detector, comprises:
periodically measuring across the drive system detector for a voltage value (“The occlusion detector measures increased reservoir pressure indirectly by monitoring one or more motor parameters, such as voltage …” – Para [13]), wherein the voltage value indicates a change of a voltage or an electrical impedance, and the drive system is damaged (“If for example, the measured current would be high (above predetermined threshold settings) … This would be an indication of a drive system fault.” – Para [24], “Although the foregoing description involved the measurement of motor current, other motor parameters … can be measured. Such parameters may include motor voltage …” – Para [31]).
Moberg does not expressly disclose periodically measuring across the electrically conductive element of the drive system detector for a voltage value.
Mounce teaches the electrically conductive element ("… U-shaped nut 114 may be made of or otherwise include a magnetic material …" - Para [0098]).
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include the electrically conductive element as taught by Mounce in order to further detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 7, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, further comprises
determining that the voltage value is substantially greater than a ground voltage (Is Current + Baseline + K? 508, Fig. 5) (“Although the foregoing description involved the measurement of motor current, other motor parameters … can be measured. Such parameters may include motor voltage …” – Para [31]).
Regarding claim 9, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, further comprises
measuring an electrical characteristic (Measure Current 507, Fig. 5)
Moberg does not expressly disclose of the electrically conductive element mounted to the piston rod
Mounce teaches of the electrically conductive element (“… U-shaped nut 114 may be made of or otherwise include a magnetic material …” – Para [0098]) mounted to the piston rod (“The rods 40a and 40b function to provide a rigid connection between a U-shaped nut 114 and the plunger 34.” – Para [0094], Fig. 7A)
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include of the electrically conductive element mounted to the piston rod as taught by Mounce in order to further detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 10, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, further comprises
indicating, by the drive system detector, damage to one or more components of the drive system when the electrical characteristic is substantially greater than zero (Is Current > Baseline + K? 508, Fig. 5) (“… if the measured motor current is some amount greater than a known, average baseline motor current … then it is determined that an occlusion condition has likely occurred.” – Para [23])
Examiner interprets the sum of the Baseline and K to be greater than zero.
Regarding claim 11, Moberg discloses a portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]), comprising:
a controller device (controller 113, Fig. 2) including a drive system detector (“… occlusion detector …” – Para [3]); and
a pump device (infusion pump 101, Fig. 1) including a drive system (drive motor 111, Fig. 2) having a piston rod (piston 109, Fig. 2), wherein the drive system detector is operable to:
sense that the drive system is damaged (“… detecting an occlusion or drive system failure in a medication infusion system …” – Abstract) based on the presence of a voltage value or an impedance ("The occlusion detector measures increased reservoir pressure indirectly by monitoring one or more motor parameters, such as voltage …" - Para [13]);
determine the measured impedance or the voltage value exceed a threshold value (Is Current + Baseline + K? 508, Fig. 5) (“Although the foregoing description involved the measurement of motor current, other motor parameters … can be measured. Such parameters may include motor voltage …” – Para [31]); and
in response to the determination the measured impedance or the voltage value exceed the threshold value (Is Current > Baseline + K? 508, Fig. 5) sensing that the drive system detector indicates the drive system is damaged (“If for example, there was a failure … the measured current would be high (above predetermined threshold settings) … This would be an indication of a drive system fault.” – Para [24]), disable the drive system from dispensing a medicine (Stop Pump 509, Fig. 5).
Moberg does not expressly disclose with an electrically conductive element that extends along the piston rod, wherein the electrically conductive element is coupled to the drive system detector, measured across the electrically conductive element;
Mounce teaches an electrically conductive element (“… U-shaped nut 114 may be made of or otherwise include a magnetic material …” – Para [0098]) that extends along the piston rod (“The rods 40a and 40b function to provide a rigid connection between a U-shaped nut 114 and the plunger 34.” – Para [0094], Fig. 7A), wherein the electrically conductive element is coupled to the drive system detector (U-shaped nut 114, Fig. 7A), measured across the electrically conductive element (“… the position of the U-shaped 114 relative to the electrical coil will have a detectable effect on the current in the coil …” – Para [0100]);
Therefore, it would have been obvious, at the time invention was made, to modify the system of Moberg to include an electrically conductive element that extends along the piston rod, wherein the electrically conductive element is coupled to the drive system detector, measured across the electrically conductive element as taught by Mounce in order to detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 12, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is operable to:
in response to the sensing that drive system detector indicates said drive system is damaged (Is current > Baseline + K? 508, Fig. 5), emit an audible alarm (Provide alarm indication 510, Fig. 5) (“Should there be an occlusion … an audible, tactile, and/or display alarm typically is triggered.” – Para [15]).
Regarding claim 13, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is operable to:
in response to the sensing that the drive system detector indicates said drive system is damaged (Is current > Baseline + K? 508, Fig. 5), display one or more alert text messages (Provide alarm indication 510, Fig. 5) (“Should there be an occlusion … an audible, tactile, and/or display alarm typically is triggered.” – Para [15]) on a user interface display of the portable infusion pump system (display panel 115, Fig. 1)
Examiner interprets a display alarm to include text messages.
Regarding claim 15, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is operable to:
receive an electrical signal (Measure Current 507, Fig. 5) indicating an electrical connection with the drive system detector has been interrupted (Is Current > Baseline + K? 508, Fig. 5), wherein receiving the electrical signal indicates the drive system is damaged (“… if the measured motor current is some amount greater than a known, average baseline motor current … then it is determined that an occlusion condition has likely occurred.” – Para [23]).
Moberg does not expressly disclose the electrically conductive element
Mounce teaches the electrically conductive element ("… U-shaped nut 114 may be made of or otherwise include a magnetic material …" - Para [0098]).
Therefore, it would have been obvious, at the time invention was made, to modify the system of Moberg to include the electrically conductive element as taught by Mounce in order to detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 16, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is sensing that the drive system of the portable infusion pump system is damaged via the drive system detector, the controller is operable to:
periodically measure across the drive system detector for a voltage value (“The occlusion detector measures increased reservoir pressure indirectly by monitoring one or more motor parameters, such as voltage …” – Para [13]), wherein the voltage value indicates a change of a voltage or an electrical impedance, and the drive system is damaged (“If for example, the measured current would be high (above predetermined threshold settings) … This would be an indication of a drive system fault.” – Para [24], “Although the foregoing description involved the measurement of motor current, other motor parameters … can be measured. Such parameters may include motor voltage …” – Para [31]).
Moberg does not expressly disclose the electrically conductive element of the drive system detector for a voltage value
Mounce teaches the electrically conductive element ("… U-shaped nut 114 may be made of or otherwise include a magnetic material …" - Para [0098]).
Therefore, it would have been obvious, at the time invention was made, to modify the system of Moberg to include the electrically conductive element as taught by Mounce in order to detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 17, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is operable to:
determining that the voltage value is substantially greater than a ground voltage (Is Current + Baseline + K? 508, Fig. 5) (“Although the foregoing description involved the measurement of motor current, other motor parameters … can be measured. Such parameters may include motor voltage …” – Para [31]).
Regarding claim 19, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is further operable to:
measure an electrical characteristic (Measure Current 507, Fig. 5)
Moberg does not expressly disclose of the electrically conductive element mounted to the piston rod
Mounce teaches of the electrically conductive element (“… U-shaped nut 114 may be made of or otherwise include a magnetic material …” – Para [0098]) mounted to the piston rod (“The rods 40a and 40b function to provide a rigid connection between a U-shaped nut 114 and the plunger 34.” – Para [0094], Fig. 7A)
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include of the electrically conductive element mounted to the piston rod as taught by Mounce in order to detect the occurrence or blockage of a fluid flow path in the infusion device (Mounce, Para [0216]).
Examiner interprets magnetic materials to include some electrically conductive elements.
Regarding claim 20, , Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is further operable to:
Indicate damage to one or more components of the drive system when the electrical characteristic is substantially greater than zero (Is Current > Baseline + K? 508, Fig. 5) (“… if the measured motor current is some amount greater than a known, average baseline motor current … then it is determined that an occlusion condition has likely occurred.” – Para [23])
Examiner interprets the sum of the Baseline and K to be greater than zero.
Claim 4 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moberg (US Patent No. 6362591) in view of Mounce et al. (US Pub No. 20080077081 A1) and in further view of Yudovsky et al. (US Pub No. 20110105955 A1).
Regarding claim 4, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, further comprising
in response to the sensing that the drive system detector indicates said drive system is damaged, activating a light source of the portable infusion pump system (Should there be an occlusion … an audible, tactile, and/or display alarm typically is triggered." - Para [15]).
Moberg does not expressly disclose activating a light source … that is different from the user interface display.
Yudovsky teaches a light source that is that is different from the user interface display ("… the controller 100 may include any number of the following alert generating elements, without limitation: … a display element (such as the touch screen display element 106); a light-emitting element (LED) …" - Para [0030])
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include a light source that is that is different from the user interface display as taught by Yudovsky in order to generate one or more types of feedback (Yudovsky, Para [0030]).
Examiner interprets a display alarm to include the activation of a light source.
Regarding claim 14, Moberg discloses the portable infusion pump system (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above, wherein the controller is operable to:
in response to the sensing that the drive system detector indicates said drive system is damaged, activate a light source of the portable infusion pump system (Should there be an occlusion … an audible, tactile, and/or display alarm typically is triggered." - Para [15]).
Moberg does not expressly disclose a light source that is that is different from the user interface display
Yudovsky teaches a light source that is that is different from the user interface display ("… the controller 100 may include any number of the following alert generating elements, without limitation: … a display element (such as the touch screen display element 106); a light-emitting element (LED) …" - Para [0030])
Therefore, it would have been obvious, at the time invention was made, to modify the system of Moberg to include a light source that is that is different from the user interface display as taught by Yudovsky in order to generate one or more types of feedback (Yudovsky, Para [0030]).
Examiner interprets a display alarm to include the activation of a light source.
Claim 8 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moberg (US Patent No. 6362591) in view of Mounce et al. (US Pub No. 20080077081 A1) and in further view of Alderete, Jr. et al. (US Pub No. 20120259282 A1).
Regarding claim 8, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above.
Moberg does not expressly disclose bypassing further sensing when the drive system detector indicates the drive system is damaged immediately upon connection of a pump device including the drive system to a controller device.
Alderete, Jr. teaches bypassing further sensing when the drive system detector indicates the drive system is damaged immediately upon connection of a pump device (housing 112, Fig. 2) including the drive system to a controller device (fluid reservoir 111, Fig. 2) (“The method detects insertion of the fluid reservoir into the housing … in response to the detecting, determines whether the fluid reservoir is in need of depressurization, the drive motor assembly is rewound to depressurize the fluid reservoir.” – Para [0022])
Therefore, it would have been obvious, at the time invention was made, to modify the method of Moberg to include bypassing further sensing when the drive system detector indicates the drive system is damaged immediately upon connection of a pump device including the drive system to a controller device as taught by Alderete Jr. for delivering fluid to a user (Alderete, Jr., Para [0022]).
Regarding claim 18, Moberg discloses the method (“A method and apparatus for automatically detecting an occlusion or drive system failure in a medication infusion system …” – Abstract, “The infusion pump can be … adapted to be carried by the user …” – Para [7]) recited above.
Moberg does not expressly disclose that the controller is further operable to bypass further sensing when the drive system detector indicates the drive system is damaged immediately upon connection of a pump device including the drive system to a controller device.
Alderete, Jr. teaches that the controller is further operable to bypass further sensing when the drive system detector indicates the drive system is damaged immediately upon connection of a pump device (housing 112, Fig. 2) including the drive system to a controller device (fluid reservoir 111, Fig. 2) (“The method detects insertion of the fluid reservoir into the housing … in response to the detecting, determines whether the fluid reservoir is in need of depressurization, the drive motor assembly is rewound to depressurize the fluid reservoir.” – Para [0022])
Therefore, it would have been obvious, at the time invention was made, to modify the system of Moberg to include bypassing further sensing when the drive system detector indicates the drive system is damaged immediately upon connection of a pump device including the drive system to a controller device as taught by Alderete Jr. for delivering fluid to a user (Alderete, Jr., Para [0022]).
Response to Arguments
Applicant’s arguments, see pages 12-15, filed 3/06/2025, with respect to the rejection(s) of claim(s) 1-4 under Double Patenting have been fully considered and are persuasive with the filing of a Terminal Disclaimer on 3/6/2025. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 12-15, filed 3/06/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 112, 102, 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Moberg in view of Monce.
Examiner interprets that the combination of Moberg in view of Monce teaches the limitations “including an electrically conductive element that extends along a piston rod of the drive system” of independent claim 1, as recited above.
Examiner interprets that the combination of Moberg in view of Monce and in further view of Yudvosky teaches the limitations of dependent claim 4, as recited above.
With respect to the applicant’s arguments, the rejection above teaches the claimed limitations of the newly added claims 5-20. The rejection above is maintained and all dependent claims are addressed in the claims they depend on.
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.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783