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 .
Notice of Current Action by Different Examiner
This application has been assigned to new examiner. The undersigned examiner has reviewed the previous search to ensure it is thorough and complete. See MPEP 904.02.
Response to Amendment
This Office action is responsive to the claims filed on 12/11/2025. As directed by the amendment: Claims 7 and 16 have been amended. Claims 7-11 and 16-17 are currently pending in the application.
Claim Objections
Regarding claims 1 and 16, the limitation "after the confirmation that the drug vial is inserted in proper position is correct for the patient" contains a grammatical and/or typographical error requiring correction.
A suggested correction is: "after the confirmation that the drug vial is inserted in proper position and is correct for the patient".
The limitation "thereby the resetting does not require having to power off and on the drug infusion device" in claim 1 contains a grammatical and/or typographical error requiring correction.
A suggested correction is "and the resetting does not require having to power off and on the drug infusion device".
Claim 16 is objected to because the phrase "confirm by the controller" is redundant. The preamble of claim 16 already recites "a controller configured to...", such that the additional recitation of "confirm by the controller" unnecessarily repeats that the controller performs the recited function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7, 8, 16 and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 7 and 16, the new matter is detecting, by the controller, an error in the infusion program, as well as the detecting occurring after the confirmation that the drug vial is inserted in the proper insertion position and is correct for the patient.
The specification is silent as to any mention of a controller detecting an error in the infusion program parameters. In some embodiments, a vial-related error check is mentioned (see paras [0056]-[0057]), in which scanned vial drug identifiers are checked against the drug library or existing infusion program. But this would not constitute an "error in the infusion program" itself. Further, para [0039] discloses a clinician determining an error made during a configuration process, but this does not constitute detection by a controller.
Accordingly, the original disclosure is also silent as to an error detecting step occurring after the confirmation of a correct and properly inserted drug vial.
Further, the original disclosure is silent as to the vial-reset signal indicating that the drug vial has been removed and reinserted (claim 16 contains similar language, but specifies that the removal occurs by clinician action).The vial-reset signal appears to be only related to the removal of the vial from the receptacle space (see specification at para [0006]); no mention is made of the signal also indicating reinsertion of the vial.
The limitation "correct for the patient" in relation to the drug vial, recited in claims 7 and 16, are also not found in the specification.
Claim 8 also recites "if the vial-reset signal is received by the controller during the delivering of the drug, stopping... the delivering of the drug and resetting... to a program review point...". Claim 17 recites a similar limitation.
However, the specification is silent as to a vial-reset signal being received by the controller during the delivery of the drug; the vial-reset signal only appears to occur before delivery of the drug.
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.
Claims 7-11, 16, and any claim(s) depending therefrom, are 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.
Regarding claims 7 and 16, it is not clear what is meant by the phrase "error in the infusion program". This term is not described in the specification or implied to the degree necessary for a person of ordinary skill in the art to ascertain its meaning.
The term "infusion program error" may be typically understood to mean a flaw or defect in software code causing the program to crash, malfunction or produce an unexpected result (e.g., syntax errors, runtime errors, logical errors, etc.); however, the specification makes no mention of this.
Further, claim 7, it is not clear what is meant by a drug vial being "correct for the patient". The specification at paras [0062]–[0066] disclose confirming that the drug vial matches the an "Rx" order and is compatible with a drug library, but does not disclose that this means "correct for the patient". The specification at para [0046] discusses patient matching that occurs before insertion of the vial, not after.
Claim 8 recites "…if the vial reset signal is not received by the controller..." However, claim 8 depends from claim 7, which requires that the vial reset signal is received by the controller. Accordingly, it is unclear how the limitation of claim 8 can be satisfied while still including all of the limitations of claim 7. Therefore, the scope of claim 8 cannot be determined with reasonable certainty.
Claims 8 and 16 also recite a "program review point" to where the drug infusion program is reset; but claims 7 and 16 also recite a vial-reset signal. It is not clear if the vial-reset point is intended to be the same, or different, than the program review point. Accordingly, the metes and bounds of the claim are unclear.
Claims 9 and 10 recite "…the point to which the method is reset is a point that allows bypassing of the receiving of the indication of whether the patient to be served by the drug infusion device is a new patient..." However, the phrase "the point to which the method is reset" lacks proper antecedent basis in the claim. Accordingly, the metes and bounds of the claim are unclear.
Further, the limitation in claim 7 of "the point to which the method is reset is a point that allows bypassing the receiving of the indication of whether the patient to be served by the drug infusion device is a new patient" is unclear because claim 7 necessarily requires receiving an indication of whether the patient to be served by the drug infusion device is a new patient. Therefore, it is not clear how claim 7 can both disclose the method step and permit bypassing of the method step at the same time.
Claim 11 recites "…setting a vial presence sensor; and upon removal of the drug vial, generating the vial-reset signal by triggering the vial presence sensor..." It is unclear what is meant by "setting a vial presence sensor" because the claim does not explain what state, configuration, or operation is being established by the "setting." Additionally, it is unclear what is meant by "triggering the vial presence sensor" because the claim does not recite any action that triggers the sensor or the meaning of the term “triggering”. Rather, the claim implies that the sensor detects the presence or absence of the drug vial. Accordingly, the scope of the claimed subject matter cannot be determined with reasonable certainty.
Claim 16 recites "…a controller configured to receive a drug vial into a receptacle space within a housing of the drug infusion device..." It is unclear how a controller, which has not been established to be a physical structure, receives a physical drug vial into a receptacle space. Accordingly, it is unclear whether Applicant intended to recite that the drug infusion device, housing, or another structural component receives the drug vial, or whether the controller merely detects or otherwise responds to insertion of the drug vial. Therefore, the metes and bounds of the claim are indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7, 8, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kaleido Insulin Infusion Pump Guidebook (ViCentra BV, published 10/31/2017, hereinafter “Kaleido Guidebook”) in view of Denzer (U.S. Pub. 2015/0045729 A1, hereinafter “Denzer”).
Regarding claim 7, Kaleido Guidebook discloses a method comprising:
performing, by a controller (such as a controller that relays information to and from a handset of a Kaleido insulin pump system and carries out instructions from the handset), a power-on self-test of a drug infusion device (see pg. 215, disclosing a pump alarm that can be issued upon determining that an infusion cartridge is expired; the pump is stopped and the user is instructed to remove the old cartridge and replace it with a new, filled cartridge before it can be restarted), the drug infusion device being capable of being connected to a patient and delivering a drug to the patient in accordance with an infusion program under control of the controller (the drug infusion device is an insulin pump that is connected to the patient and delivers insulin in accordance with basal and bolus parameters);
receiving a drug vial (insulin cartridge filled with insulin; see pg. 37, step 15) into a receptacle space (see pg. 39, step 4, disclosing pushing the pump onto the insulin cartridge "until you hear it click into place") within a housing of the drug infusion device (the casing of a fully charged pump; see pg. 25, step 4 into which is placed the insulin cartridge);
configuring, by the controller, the drug infusion device according to infusion parameters specified by the infusion program (e.g., the setting of a new basal profile disclosed on pg. 71, and/or the setting of a temporary basal rate disclosed on pg. 91; Examiner notes that the method does not actively recite, or logically imply, a specific order of steps, and therefore the steps may be generally performed in any sequence; in this case, the "configuring, by the controller step" is not required by the claims to occur before the "confirming" step discussed below);
confirming, by the controller, that the drug vial is inserted in a proper insertion position and is correct for the patient (see pg. 39, disclosing that "To let you know it has detected the inserted insulin cartridge, your pump will beep twice"; and see also pg. 40, disclosing that "your pump…can tell when you've inserted a new insulin cartridge into your pump");
prompting, by the controller with a series of prompts, a clinician to review the infusion program after confirmation that the drug vial is inserted in the proper insertion position and is correct for the patient (see pg. 49, showing a Home screen on the handset which shows the infusion program after the cannula is primed after proper insertion of the cartridge);
detecting, by the controller, an error in the infusion program after the confirmation that the drug vial is inserted in proper position and is correct for the patient (see pg. 198-199, disclosing steps to pause the pump, which causes the controller to issue a warning that a specific amount of insulin has failed to be delivered since pumping was paused; a pause to the delivery implicitly occurs after the pumping has started, and thus after the confirmation of proper drug vial insertion);
receiving, by the controller, a vial-reset signal, the vial-reset signal indicating that the drug vial has been removed from the receptacle space by the clinician after detection of the error and the same drug vial has been reinserted back into the receptacle space (see pgs. 45-47, disclosing pausing or stopping the pump; separating the cartridge from the infusion set; reinserting the cartridge back into the pump; confirming, on the handset, that the insulin cartridge in the pump is the same cartridge that was last used; sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step);
and resetting, by the controller, a configuration of an infusion program to a point after the performing of a power-on self-test automatically based on the received vial-reset signal from a sensor indicating that the vial has been removed and reinserted, thereby the resetting does not require having to power off and on the drug infusion device (see pg. 49, showing a screen indicating that the pump has been restarted and is currently running a specific daily basal profile; this resetting step does not appear to require actually turning off the pump itself, but rather, merely pausing or stopping it in order to remove the cartridge).
It is noted that Kaleido does not explicitly disclose that the receptacle space comprises a sensor configured to detect installation or removal of the drug vial in the receptacle space, and the sensor sends the vial-reset signal. That is, though Kaleido discloses detection of installation of removal of the drug vial in the receptacle space, Kaleido does not disclose the use of a sensor of the receptacle space performs this function.
Denzer discloses a method of delivering a drug to a patient from a vial, comprising receiving a drug vial (cassette 200) into a receptacle space (cassette receiving section 306) within a housing (casing 302) of the drug infusion device (see Figs. 6A and 8), wherein the receptacle space comprises a sensor (detector 370) configured to detect installation or removal of the drug vial in the receptacle space (the projection(s) 210P may be sensed by or engage a detector 370 in the autoinjector 300 when the cassette 200 is inserted into the door 308 of the autoinjector 300 and the door 308 is closed; the detector 370 is electrically coupled to a microprocessor contained within the autoinjector 300, which enables the autoinjector 300 to read the cassette identification arrangement to thereby identify the cassette 200; see para. [0086], lines 10–18);
and using the sensor to send a vial-reset signal indicating that the drug vial has been removed from the receptacle (see an off, door closed signal block from the sensor; see also paras [0086] and [0106]).
A skilled artisan would have found it obvious at the time of the invention to modify the method so that the that detection of installation or removal of the drug vial (i.e., cartridge) occurs by the use of a sensor in the receptacle space, the sensor also sending the vial-reset signal, as a well-known way to determine whether the cartridge is properly inserted in the pump or not. Since Kaleido Guidebook already discloses detecting the installation or removal of the cartridge (see above), using a sensor taught by Denzer to carry out this function would have been a matter of routine skill to a person of ordinary skill in the art, resulting in the predictable success of properly determining the insertion/removal of the cartridge for carrying out the other steps taught in Kaleido Guidebook.
Regarding claim 8, Kaleido Guidebook discloses: delivering, under control of the controller, the drug from the drug vial to the patient; if the vial-reset signal is received by the controller during the delivering of the drug, stopping, by the controller, the delivering of the drug and resetting, by the controller, the method to a program review point where a subsequent option is for at least one of retain, clear, and modify the infusion program (i.e., when the insulin cartridge in the pump is the same cartridge that was last used, sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step);
and if the vial-reset signal is not received by the controller during the delivering of the drug, continue delivering the drug (i.e., if the user does not remove and reinstall the pump at all, the drug pump continues uninterrupted in its normal operating manner).
Regarding claim 16, Kaleido Guidebook discloses a controller (such as a controller that relays information to and from a handset of a Kaleido insulin pump system and carries out instructions from the handset; see explanation, below),configured to:
perform a power-on self-test of a drug infusion device (see pg. 215, disclosing a pump alarm that can be issued upon determining that an infusion cartridge is expired; the pump is stopped and the user is instructed to remove the old cartridge and replace it with a new, filled cartridge before it can be restarted), the drug infusion device being capable of being connected to a patient and delivering a drug to the patient in accordance with an infusion program under control of the controller (the drug infusion device is an insulin pump that is connected to the patient and delivers insulin in accordance with basal and bolus parameters);
receive a drug vial (insulin cartridge filled with insulin; see pg. 37, step 15) into a receptacle space (see pg. 39, step 4, disclosing pushing the pump onto the insulin cartridge "until you hear it click into place") within a housing of the drug infusion device (the casing of a fully charged pump; see pg. 25, step 4 into which is placed the insulin cartridge);
configure the drug infusion device according to infusion parameters specified by the infusion program (e.g., the setting of a new basal profile disclosed on pg. 71, and/or the setting of a temporary basal rate disclosed on pg. 91; Examiner notes that the method does not actively recite, or logically imply, a specific order of steps, and therefore the steps may be generally performed in any sequence; in this case, the "configuring, by the controller step" is not required by the claims to occur before the "confirming" step discussed below);
confirm that the drug vial is inserted in a proper insertion position and is correct for the patient (see pg. 39, disclosing that "To let you know it has detected the inserted insulin cartridge, your pump will beep twice"; and see also pg. 40, disclosing that "your pump…can tell when you've inserted a new insulin cartridge into your pump");
prompt, with a series of prompts, a clinician to review the infusion program after confirmation that the drug vial is inserted in the proper insertion position and is correct for the patient (see pg. 49, showing a Home screen on the handset which shows the infusion program after the cannula is primed after proper insertion of the cartridge);
detect an error in the infusion program after the confirmation that the drug vial is inserted in proper position and is correct for the patient (see pg. 198-199, disclosing steps to pause the pump, which causes the controller to issue a warning that a specific amount of insulin has failed to be delivered since pumping was paused; a pause to the delivery implicitly occurs after the pumping has started, and thus after the confirmation of proper drug vial insertion);
receiving, by the controller, a vial-reset signal, the vial-reset signal indicating that the drug vial has been removed from the receptacle space by the clinician after detection of the error and the same drug vial has been reinserted back into the receptacle space (see pgs. 45-47, disclosing pausing or stopping the pump; separating the cartridge from the infusion set; reinserting the cartridge back into the pump; confirming, on the handset, that the insulin cartridge in the pump is the same cartridge that was last used; sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step);
and reset a configuration of an infusion program to a point after the performing of a power-on self-test automatically based on the received vial-reset signal from a sensor indicating that the vial has been removed and reinserted, thereby the resetting does not require having to power off and on the drug infusion device (see pg. 49, showing a screen indicating that the pump has been restarted and is currently running a specific daily basal profile; this resetting step does not appear to require actually turning off the pump itself, but rather, merely pausing or stopping it in order to remove the cartridge).
It is noted that Kaleido does not explicitly disclose that the receptacle space comprises a sensor configured to detect installation or removal of the drug vial in the receptacle space, and the sensor sends the vial-reset signal. That is, though Kaleido discloses detection of installation of removal of the drug vial in the receptacle space, Kaleido does not disclose the use of a sensor of the receptacle space performs this function.
Denzer discloses a method of delivering a drug to a patient from a vial, comprising receiving a drug vial (cassette 200) into a receptacle space (cassette receiving section 306) within a housing (casing 302) of the drug infusion device (see Figs. 6A and 8), wherein the receptacle space comprises a sensor (detector 370) configured to detect installation or removal of the drug vial in the receptacle space (the projection(s) 210P may be sensed by or engage a detector 370 in the autoinjector 300 when the cassette 200 is inserted into the door 308 of the autoinjector 300 and the door 308 is closed; the detector 370 is electrically coupled to a microprocessor contained within the autoinjector 300, which enables the autoinjector 300 to read the cassette identification arrangement to thereby identify the cassette 200; see para. [0086], lines 10–18);
and using the sensor to send a vial-reset signal indicating that the drug vial has been removed from the receptacle (see an off, door closed signal block from the sensor; see also paras [0086] and [0106]).
A skilled artisan would have found it obvious at the time of the invention to modify the method so that the that detection of installation or removal of the drug vial (i.e., cartridge) occurs by the use of a sensor in the receptacle space, the sensor also sending the vial-reset signal, as a well-known way to determine whether the cartridge is properly inserted in the pump or not. Since Kaleido Guidebook already discloses detecting the installation or removal of the cartridge (see above), using a sensor taught by Denzer to carry out this function would have been a matter of routine skill to a person of ordinary skill in the art, resulting in the predictable success of properly determining the insertion/removal of the cartridge for carrying out the other steps taught in Kaleido Guidebook.
Regarding claim 17, Kaleido Guidebook discloses: controlling delivery of the drug from the drug vial to the patient; stopping, by the controller, the delivering of the drug and resetting, by the controller, the method to a program review point where a subsequent option is for at least one of retain, clear, and modify the infusion program (i.e., when the insulin cartridge in the pump is the same cartridge that was last used, sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step).
Claims 7-9, 11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Denzer (U.S. Pub. 2015/0045729 A1, hereinafter “Denzer”), in view of Kaleido Guidebook.
Regarding claim 7, Denzer discloses a method comprising:
performing, by a controller (microprocessor 350; see Fig. 8), a power-on self-test of a drug infusion device (a power-on self-test is automatically performed upon waking the autoinjector 300 to ensure sufficient battery power is available for a successful injection cycle; see para. [0116], lines 5–7), the drug infusion device being capable of being connected to a patient and delivering a drug to the patient in accordance with an infusion program under control of the controller (see para. [0105]);
receiving a drug vial (cassette 200) into a receptacle space (cassette receiving section 306) within a housing (casing 302) of the drug infusion device (see Figs. 6A and 8), wherein the receptacle space comprises a sensor (detector 370) configured to detect installation or removal of the drug vial in the receptacle space (the projection(s) 210P may be sensed by or engage a detector 370 in the autoinjector 300 when the cassette 200 is inserted into the door 308 of the autoinjector 300 and the door 308 is closed. The detector 370 may be electrically coupled to a microprocessor (e.g., microprocessor 350 illustrated in Fig. 8) contained within the autoinjector 300, which enables the autoinjector 300 to read the cassette identification arrangement to thereby identify the cassette 200; see para. [0086], lines 10–18);
configuring, by the controller, the drug infusion device according to infusion parameters (elapsed predetermined time, e.g., 0.5 or 5 seconds) specified by the infusion program (instructions; see Figs.9A-B; paras. [0109]-[0110]);
confirming, by the controller, that the drug vial is inserted in a proper insertion position and is correct for the patient (the detector 370 is electrically coupled to the microprocessor 350, and the detector detects that the cassette 200 is properly installed and is valid for the drug delivery profile; see para. [0086]);
prompting, by the controller with a series of prompts (see Figs. 9A–B), a clinician to review the infusion program (review error occurrences via a user interface 312; see paras. [0100], [0106]–[0107]) after confirmation that the drug vial is inserted in the proper insertion position and is correct for the patient (the confirmation that the cassette (200) is inserted properly and valid is performed before reviewing error occurrences; see paras. [0086] and [0106]–[0107]);
detecting, by the controller, an error in the infusion program after the confirmation that the drug vial is inserted in proper position and is correct for the patient (see para [0106], disclosing various errors such as excessive autoinjector life, excessive number of injections, unrecoverable device error, dead autoinjector battery, or low temperature; Denzer discloses that after such error, a user can remove the cassette and close the door, prompting the microprocessor to place the autoinjector in the "off, door closed" state);
receiving, by the controller, a vial-reset signal (the aforementioned “off, door closed,” signal block 500) from the sensor, the vial-reset signal indicating that the drug vial has been removed from the receptacle space by the clinician (para. [0086], lines 13–18; para. [0106], lines 31–34) after detection of the error.
Denzer does not appear to disclose that the receiving of the vial-reset signal occurs after the detection of an error and the same drug vial has been reinserted back into the receptacle space;
and resetting, by the controller, a configuration of an infusion program to a point after the performing of a power-on self-test automatically based on the received vial-reset signal from a sensor indicating that the vial has been removed and reinserted, thereby the resetting does not require having to power off and on the drug infusion device.
Kaleido Guidebook discloses it may be desirable or necessary to "sometimes" remove an insulin cartridge from the pump for various reasons, and then reinsert the same cartridge later on "to carry on using it" (see pg. 45). Kaleido Guidebook discloses first pausing or stopping the pump; separating the cartridge from the infusion set; reinserting the cartridge back into the pump; confirming, on the handset, that the insulin cartridge in the pump is the same cartridge that was last used; sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step (see pgs. 45-47), which occurs after performing a self-test (see pg. 49, showing a screen indicating that the pump has been restarted and is currently running a specific daily basal profile; this resetting step does not appear to require actually turning off the pump itself, but rather, merely pausing or stopping it in order to remove the cartridge).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Denzer to incorporate the teachings of Kaleido Guidebook, in order to permit a user to remove and replace a cartridge, as was known in the art, without requiring completely resetting the device, with a reasonable expectation of success in saving time and battery power of the pump and its associated handset).
Regarding claim 8, Denzer as modified discloses the method of claim 7 and further discloses delivering, under control of the controller, the drug from the drug vial to the patient (see para. [0105], lines 1–11). Kaleido Guidebook further discloses: delivering, under control of the controller, the drug from the drug vial to the patient; if the vial-reset signal is received by the controller during the delivering of the drug, stopping, by the controller, the delivering of the drug and resetting, by the controller, the method to a program review point where a subsequent option is for at least one of retain, clear, and modify the infusion program (i.e., when the insulin cartridge in the pump is the same cartridge that was last used, sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step);
and if the vial-reset signal is not received by the controller during the delivering of the drug, continue delivering the drug (i.e., if the user does not remove and reinstall the pump at all, the drug pump continues uninterrupted in its normal operating manner).
Regarding claim 9, Kaleido Guidebook discloses after performing the power-on self-test and before configuring the drug infusion device, receiving, by the controller, an indication of whether the patient to be served by the drug infusion device is a new patient (see pg. 137, disclosing that patient information is input into the controller of the pump before it is shipped to the patient, and can be checked by the user before any other system settings can be changed),
wherein the point to which the method is reset is a point that allows bypassing the receiving of the indication of whether the patient to be served by the drug infusion device is a new patient (i.e., reinserting the drug vial does not require the patient to check patient information; the patient can simply proceed to continuing the infusion program after reinserting the vial).
A skilled artisan would have found it obvious at the time of the invention to modify the controller of Denzer to carry out this function, in order to provide important details regarding the operation of the pump (such as the patient's height, weight, target BG, insulin to carb ratio, etc., prior to determining the proper infusion program, with a reasonable expectation of success.
Regarding claim 11, Denzer as modified discloses the method of claim 7 and further discloses, upon receiving the drug vial (200) into the receptacle space (306), setting a vial presence sensor (para. [0086], lines 10–18); and upon removal of the drug vial (see para. [0106], lines 31–34), generating the vial-reset signal by triggering the vial presence sensor (see para. [0086], lines 10–18).
Regarding claim 16, Denzer discloses a controller configured to: perform a power-on self-test of a drug infusion device (a power-on self-test is automatically performed upon waking the autoinjector 300 to ensure sufficient battery power is available for a successful injection cycle; see para. [0116], lines 5–7), the drug infusion device being capable of being connected to a patient and delivering a drug to the patient in accordance with an infusion program under control of the controller (see para. [0105]);
receive a drug vial (200) into a receptacle space (306) within a housing (302) of the drug infusion device (see Figs. 6A and 8), wherein the receptacle space comprises a sensor (370) configured to detect installation or removal of the drug vial in the receptacle space (the projection(s) 210P may be sensed by or engage a detector 370 in the autoinjector 300 when the cassette 200 is inserted into the door 308 of the autoinjector 300 and the door 308 is closed. The detector 370 may be electrically coupled to a microprocessor (e.g., microprocessor 350 illustrated in Fig. 8) contained within the autoinjector 300, which enables the autoinjector 300 to read the cassette identification arrangement to thereby identify the cassette 200; see para. [0086], lines 10–18); configure the drug infusion device according to infusion parameters (e.g., elapsed predetermined time, e.g., 0.5 or 5 seconds) specified by the infusion program (instructions; see Figs. 9A–B; see paras. [0109]–[0110]);
confirm, by the controller, that the drug vial is inserted in a proper insertion position and is correct for the patient (the detector (370) is electrically coupled to the microprocessor (350), wherein the detector detects that the cassette (200) is properly installed (via projections (210P) located at the bottom surface of the outer housing of the cassette) and is correct for the patient (drug delivery profile/valid cassette; see para. [0086]));
prompt, with a series of prompts (see Figs. 9A–B), a clinician to review the infusion program (review error occurrences via a user interface 312; see para. [0100] and paras. [0106]–[0107]) after confirmation that the drug vial is inserted in a proper insertion position and is correct for the patient (the confirmation that the cassette (200) is inserted properly and valid is performed before reviewing error occurrences; see paras. [0086] and [0106]–[0107]);
detect an error in the infusion program after the confirmation that the drug vial is inserted in proper position and is correct for the patient (see para [0106], disclosing various errors such as excessive autoinjector life, excessive number of injections, unrecoverable device error, dead autoinjector battery, or low temperature; Denzer discloses that after such error, a user can remove the cassette and close the door, prompting the microprocessor to place the autoinjector in the "off, door closed" state);
receive a vial-reset signal (the aforementioned “off, door closed,” signal block 500) from the sensor, the vial-reset signal indicating that the drug vial has been removed from the receptacle space by the clinician (para. [0086], lines 13–18; para. [0106], lines 31–34) after detection of the error; and
continue the infusion program based on not receiving any vial-reset signal (when a full ampoule is loaded, the injection process starts and finishes when the maximum service life is reached; see para. [0068]).
Denzer does not appear to disclose a vial-reset signal indicating that the drug vial has been removed from the receptacle space and that the same drug vial has been reinserted back into the receptacle space by the clinician after detection of the error, and resetting the infusion program based on receiving the vial-reset signal, wherein the infusion program is reset without having to power off and on the drug infusion device.
Kaleido Guidebook discloses it may be desirable or necessary to "sometimes" remove an insulin cartridge from the pump for various reasons, and then reinsert the same cartridge later on "to carry on using it" (see pg. 45). Kaleido Guidebook discloses first pausing or stopping the pump; separating the cartridge from the infusion set; reinserting the cartridge back into the pump; confirming, on the handset, that the insulin cartridge in the pump is the same cartridge that was last used; sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step (see pgs. 45-47), which occurs after performing a self-test (see pg. 49, showing a screen indicating that the pump has been restarted and is currently running a specific daily basal profile; this resetting step does not appear to require actually turning off the pump itself, but rather, merely pausing or stopping it in order to remove the cartridge).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Denzer to incorporate the teachings of Kaleido Guidebook, in order to permit a user to remove and replace a cartridge, as was known in the art, without requiring completely resetting the device, with a reasonable expectation of success in saving time and battery power of the pump and its associated handset).
Regarding claim 17, Denzer discloses control of delivery of the drug from the drug vial to the patient (see para. [0105], lines 1–11). Kaleido Guidebook further discloses: stopping, by the controller, the delivering of the drug and resetting, by the controller, the method to a program review point where a subsequent option is for at least one of retain, clear, and modify the infusion program (i.e., when the insulin cartridge in the pump is the same cartridge that was last used, sending the signal of the confirmation to the controller, at which point the controller prompts the user to select a new infusion set or a priming step);
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Denzer, in view of Kaleido Guidebook, further in view of Gelfand (U.S> Pub. 2006/0270971 A1, hereinafter "Gelfand"), in view of Chaco (U.S. Pub. 2002/0044043, hereinafter "Chaco").
Regarding claim 10, Denzer does not appear to disclose after the receiving of the indication of whether the patient to be served by the drug infusion device is a new patient, receiving, by the controller, an indication of a clinical care area in which the patient is to be served by the drug infusion device; wherein the point to which the method is reset is a point before the receiving of the indication of the clinical care area.
Gelfand teaches an infusion pump, along with an indication of a clinical care area (the new patient identification is performed at a point in a predetermined 20×20 inch area; an RS-232 port is also provided, such that when mounted on an I.V. pole, the system requires an area of approximately 20×20 inches; see para. [0151], lines 8–10).
Chaco also teaches that it was known in the art to provide a controller (2420; Fig. 1) with a processing unit (2412) that identifies a patient’s room number (the CPU prioritizes the message frame utilizing transition priority data of the PATH field and then sends, to the nurse control station or stations connected in the group associated with the patient station, a message frame including tone and display data identifying the patient and the associated room number (steps 3880 and 3890; see para. [0126], lines 11–16)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Denzer and Kaleido Guidebook to incorporate the teachings of Gelfand and Chaco, thereby providing a controller that identifies the clinical care area where drug infusion is performed, in order to improve patient tracking and reduce the risk of medication errors by ensuring the correct patient is associated with the correct treatment location, with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered, but they are moot in view of the new grounds of rejection.
Conclusion
THIS ACTION IS MADE NON-FINAL.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/07/2026
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