DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. According to the Amendment, filed 30 January 2026, the status of the claims is as follows:
Claims 21, 25, 27, 30, 35, and 36 are currently amended;
Claims 22-24, 26, 31-34, and 37-40 are previously presented;
Claims 41 and 42 are new; and
Claims 1-20, 28, and 29 are cancelled.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 6-9, filed 30 January 2026, with respect to the rejection of claims 21-24 and 26-40 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Flaherty et al., U.S. Patent Application Publication No. 2002/0040208 A1 (“Flaherty”), have been fully considered, and are persuasive in view of the Amendment, filed 30 January 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
4. Applicant’s arguments, see Remarks, pp. 9-10, filed 30 January 2026, with respect to the rejection of claims 25 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flaherty, as applied to claim 21, and further in view of Flaherty et al., U.S. Patent Application Publication No. 2004/0010207 A1 (“Flaherty ‘207”), have been fully considered, and are persuasive in view of the Amendment, filed 30 January 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
6. Claims 21-24, 26, 27 and 30-42 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Hansen et al., W.O. 2006/120253 A2 (“Hansen”).
As to Claim 21, Hansen teaches the following:
An insulin delivery device (“medical device”) 1000 (see “In a specific aspect, the invention relates to such a device adapted to detect a condition which may lead to failure in the controlled delivery of an amount of drug to a subject.” in p. 1, ll. 5-7; and see “More specifically, fig. 12 shows an embodiment of a medical device 1000, comprising a cannula unit 1010 of the type shown in fig. 10 and a thereto mountable pump (or reservoir) unit 1050. In the shown embodiment the cannula unit comprises a housing 1015 with a shaft into which a portion 1051 of the pump unit is inserted.” in p. 23, ll. 14-18, and figs. 10-14), comprising:
a patch (“patch unit”) 400/900/1010 comprising a bottom surface (“lower mounting surface”) 431 having an adhesive (“adhesive”, not labeled) for securing the patch 400 to a skin surface of a patient (see “Fig. 10 shows a skin-mountable device in the form of a patch (or cannula) unit 400. The patch unit comprises a relatively rigid body portion 414 arranged on a flexible sheet member 430 with a lower mounting surface 431 provided with an adhesive allowing the sheet to be adhered to a skin surface of a subject.” in p. 22, ll. 29-32), wherein the patch 400 comprises a long axis (see axis, not labeled, from top of drawing to bottom of drawing in fig. 10) and a short axis (see axis, not labeled, from left of drawing to right of drawing in fig. 10);
a pump (“pump unit”) 450/1050 for delivering insulin to the patient (see “The housing further comprises a fluid inlet 415 adapted to be mounted in fluid communication with a correspond-ing fluid outlet from an attached pump unit 450, an actuator 416 for actuating an electrical contact on the attached pump, and a release member 417 adapted to release a cannula inserting mechanism when the pump unit is attached for the first time, the cannula being inserted through the opening 432.” in p. 23, ll. 3-8), wherein the pump 45/1050 is coupled to the patch 400/900/1010 and is arranged along the long axis of the patch 400/900/1010 (see “The housing further comprises a fluid inlet 415 adapted to be mounted in fluid communication with a correspond-ing fluid outlet from an attached pump unit 450, …” in p. 23, ll. 3-5), the pump 450/1050 (see “With reference to figs. 1 -9 and 16 a reciprocating coil actuator adapted to be used in combination with a reciprocating membrane pump has been described, however, the present invention is also applicable in combination with other types of expelling assemblies and actuators. With reference to fig. 20 a further drug delivery device 600 will be described.” in p. 33, l. 31, to p. 34, l. 1, and fig. 20) comprising:
a reservoir (“cylindrical reservoir”) 620 configured to store insulin (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20);
a plunger (“attached plunger”) 622 for moving the insulin out of the reservoir 620 (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20);
an actuator (“reciprocating actuator”) 640 configured to advance the plunger 622 through the reservoir 620 (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20); and
a cannula (“fluid outlet 630” or “cannula 951”) 630/951 in fluid communication with the reservoir 620 and configured to be automatically inserted into an infusion site of the patient to deliver the insulin (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20);
a power source (“battery 366”) 366 comprising one or more batteries configured to power the pump 450/1050 (see “The electronic control means 360 comprises a PCB or flex-print 362 with a processor 361 for controlling the pump assembly, a battery 366, an acoustic transducer 365 providing an alarm and communication interface with the user, as well as a contact mounted on the actuator al- lowing the control means to be activated by the user when taken into use for the first time (via the actuator 216).” in p. 28, ll. 27-31, and fig. 16), wherein the power source 366/661 is arranged on a first side (“upper housing portion”) 310 of the patch 400/900/1010 (see “battery 366” arranged in the top side or “upper housing portion 310” in fig. 16, and see p. 27, ll. 21-25, and p. 28, ll. 27-31) and the pump 450/1050 is arranged on an opposing, second side (“lower housing portion”) 320 of the patch 400/900/1010 (see “pump assembly 330” arranged in the bottom side or “lower housing portion 320” in fig. 16, and see p. 27, l. 28, to p. 28, l. 5); and
a controller and transmitter module (“electronic control means”) 360 coupled to the patch 400/900/1010 (see “The electronic control means 360 comprises a PCB or flex-print 362 with a processor 361 for controlling the pump assembly, a battery 366, an acoustic transducer 365 providing an alarm and communication interface with the user, as well as a contact mounted on the actuator al-lowing the control means to be activated by the user when taken into use for the first time (via the actuator 216).” in p. 28, 27-31), wherein the controller and transmitter module 360 comprises an antenna (“a receiver and/or a transmitter”, not labeled) configured to wirelessly communicate with a hand-held user interface device (“remote controller”, not labeled, or “remote control unit 770”) 770 (see “The control means may comprise a receiver and/or a transmitter allowing the reservoir to communicate wirelessly with a remote controller.” in p. 28, ll. 31-32), wherein the controller and transmitter module 360 is configured to operate the pump 450/1050 to deliver insulin based on signals received from the hand-held user interface device (see “The drug delivery device 700 further comprises a remote control unit 770 adapted to wire- lessly communicate with the processor of the pump unit. The remote unit comprises a display 771 and user input keys 772, this allowing the remote unit to display information received from the pump unit (e.g. a visual and/or audible or tactile alarm indicating that the transcutaneous access device has disengaged from its subcutaneous position), and the user to enter flow control commands and instructions on the remote unit which is then transmitted to the pump unit. Indeed, such a remote control unit may also be used in combination with the above-disclosed pump units.” in p. 34, ll. 27-35, and fig. 21).
As to Claim 22, Hansen teaches the following:
wherein the cannula 951 is configured to extend through an opening (“central opening”) 432 at a perimeter of the patch 400 (see figs. 10 and 11).
As to Claim 23, Hansen teaches the following:
wherein the insulin delivery device 1000 is configured to administer insulin based on glucose measurements (see “Although drug infusion pumps, either disposable or durable, may provide convenience of use and improved treatment control, it has long been an object to provide a drug infusion system for the treatment of e.g. diabetes which would rely on closed loop control, i.e. being more or less fully automatic, such a system being based on the measurement of a value indicative of the condition treated, e.g. the blood glucose level in case of insulin treatment of diabetes. A given monitor system for measuring the concentration of a given substance may be based on invasive or non-invasive measuring principles. An example of the latter would be a noninvasive glucose monitor arranged on the skin surface of a patient and using near-IR spectroscopy. The sensor may be placed subcutaneously being connected to external equipment by wiring or the substance (fluid) to be analysed may be transported to an external sensor element, both arrangements requiring the placement of a subcutaneous component, the present invention addressing both arrangements.” in p. 2, l. 28, to p. 3, l. 7).
As to Claim 24, Hansen teaches the following:
wherein the patch 400/900/1010 comprises a rectangular shape (see shape of “patch unit” 400/900/1010 in figs. 10 and 12).
As to Claim 26, Hansen teaches the following:
wherein the actuator 640 comprises a motor (“drive mechanism 641” or “re-volving motor 740”) 641/740 (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5; and see “The device comprises a housing 710, a cylindrical reservoir 720 with a piston 721 and a thereto attached plunger 722, a fluid outlet 730 connected to an infusion set 731 via a flexible tube 732, a re- volving motor 740, and a drive mechanism 741 arranged between the motor and the plunger for transforming the motor input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 22-26).
As to Claim 27, Hansen teaches the following:
wherein the power source 366/661 is arranged on the first side (“upper housing portion”) 310 of the patch 400/900/1010 (see “battery 366” arranged in the top side or “upper housing portion 310” in fig. 16, and see p. 27, ll. 21-25, and p. 28, ll. 27-31) and the pump 450/1050 is arranged on the opposing, second side (“lower housing portion”) 320 of the patch 400/900/1010 in a direction of the short axis of the patch 400/900/1010 (see “pump assembly 330” arranged in the bottom side or “lower housing portion 320” in fig. 16, and see p. 27, l. 28, to p. 28, l. 5), wherein the short axis is perpendicular to the long axis in a plane of the patch 400/900/1010 (see fig. 16).
As to Claim 30, Hansen teaches the following:
wherein the patch 900 is more flexible along the short axis than along the long axis (see “The bottom part 910 further comprises two opposed leg portions 918 each with a lobe 919, the lobes providing attachment points when the bottom part is mounted to a flexible sheet or foil member 901 comprising an adhesive lower mounting surface 904 allowing the transcutaneous unit to be mounted on a skin surface of a subject.” in p. 25, ll. 18-21).
As to Claim 31, Hansen teaches the following:
wherein the antenna (“a receiver and/or a transmitter”, not labeled) extends along the long axis of the patch 400/900 (see “electronic control means 360” extending along the long axis of “pump unit 300” in fig. 16, the “electronic control means 360” comprise “a receiver and/or a transmitter “, see p. 28, ll. 31-32).
As to Claim 32, Hansen teaches the following:
wherein the pump 450/1050 has a maximum thickness of 0.75 inches (this dimension is within the scope of Hansen’s disclosure, see “The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are in- tended to serve illustrative purposes only.” in p. 16, ll. 3-5).
As to Claim 33, Hansen teaches the following:
wherein the patch 1010 comprises a non-woven material (see “The housing 1015 is provided with a pair of opposed legs 1018 and is mounted on top of a flexible sheet member 1019 with a lower adhesive surface 1020 serving as a mounting surface, the sheet member comprising an opening 1016 for the cannula 1017.” in p. 23, ll. 22-25).
As to Claim 34, Hansen teaches the following:
wherein the antenna (“a receiver and/or a transmitter”, not labeled) comprises a conductive layer on the patch 400 (see “The control means may comprise a receiver and/or a transmitter allowing the reservoir to communicate wirelessly with a remote controller.” in p. 28, ll. 31-32).
As to Claim 35, Hansen teaches the following:
An insulin delivery system (see “In a specific aspect, the invention relates to such a device adapted to detect a condition which may lead to failure in the controlled delivery of an amount of drug to a subject.” in p. 1, ll. 5-7; and figs. 10-14), comprising:
a hand-held user interface device (“remote controller”, not labeled, or “remote control unit 770”) 770 (see fig. 21); and
an insulin delivery device (“medical device”) 1000 (see “More specifically, fig. 12 shows an embodiment of a medical device 1000, comprising a cannula unit 1010 of the type shown in fig. 10 and a thereto mountable pump (or reservoir) unit 1050. In the shown embodiment the cannula unit comprises a housing 1015 with a shaft into which a portion 1051 of the pump unit is inserted.” in p. 23, ll. 14-18) in wireless communication with the hand-held user interface device 770 to receive control signals for delivery of insulin (see “The drug delivery device 700 further comprises a remote control unit 770 adapted to wire-lessly communicate with the processor of the pump unit. The remote unit comprises a display 771 and user input keys 772, this allowing the remote unit to display information received from the pump unit (e.g. a visual and/or audible or tactile alarm indicating that the transcutaneous access device has disengaged from its subcutaneous position), and the user to enter flow control commands and instructions on the remote unit which is then transmitted to the pump unit. Indeed, such a remote control unit may also be used in combination with the above-disclosed pump units.” in p. 34, ll. 27-35, and fig. 21), the insulin delivery device 1000 comprising:
a patch (“patch unit”) 400/900/1010 comprising a bottom surface (“lower mounting surface”) 431 having an adhesive (“adhesive”, not labeled) for securing the patch 400 to a skin surface of a patient (see “Fig. 10 shows a skin-mountable device in the form of a patch (or cannula) unit 400. The patch unit comprises a relatively rigid body portion 414 arranged on a flexible sheet member 430 with a lower mounting surface 431 provided with an adhesive allowing the sheet to be adhered to a skin surface of a subject.” in p. 22, ll. 29-32), wherein the patch 400 comprises a long axis (see axis, not labeled, from top of drawing to bottom of drawing in fig. 10) and a short axis (see axis, not labeled, from left of drawing to right of drawing in fig. 10);
a pump (“pump unit”) 450/1050 for delivering insulin to the patient (see “The housing further comprises a fluid inlet 415 adapted to be mounted in fluid communication with a correspond-ing fluid outlet from an attached pump unit 450, an actuator 416 for actuating an electrical contact on the attached pump, and a release member 417 adapted to release a cannula inserting mechanism when the pump unit is attached for the first time, the cannula being inserted through the opening 432.” in p. 23, ll. 3-8), wherein the pump 45/1050 is coupled to the patch 400/900/1010 and is arranged along the long axis of the patch 400/900/1010 (see “The housing further comprises a fluid inlet 415 adapted to be mounted in fluid communication with a correspond-ing fluid outlet from an attached pump unit 450, …” in p. 23, ll. 3-5), the pump 450/1050 (see “With reference to figs. 1 -9 and 16 a reciprocating coil actuator adapted to be used in combination with a reciprocating membrane pump has been described, however, the present invention is also applicable in combination with other types of expelling assemblies and actuators. With reference to fig. 20 a further drug delivery device 600 will be described.” in p. 33, l. 31, to p. 34, l. 1, and fig. 20) comprising:
a reservoir (“cylindrical reservoir”) 620 configured to store insulin (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20);
a plunger (“attached plunger”) 622 for moving the insulin out of the reservoir 620 (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20);
an actuator (“reciprocating actuator”) 640 configured to advance the plunger 622 through the reservoir 620 (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20); and
a cannula (“fluid outlet 630” or “cannula 951”) 630/951 in fluid communication with the reservoir 620 and configured to be automatically inserted into an infusion site of the patient to deliver the insulin (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20);
a power source (“battery 366”) 366 comprising one or more batteries configured to power the pump 450/1050 (see “The electronic control means 360 comprises a PCB or flex-print 362 with a processor 361 for controlling the pump assembly, a battery 366, an acoustic transducer 365 providing an alarm and communication interface with the user, as well as a contact mounted on the actuator al- lowing the control means to be activated by the user when taken into use for the first time (via the actuator 216).” in p. 28, ll. 27-31, and fig. 16), wherein the power source 366/661 is arranged on a first side (“upper housing portion”) 310 of the patch 400/900/1010 (see “battery 366” arranged in the top side or “upper housing portion 310” in fig. 16, and see p. 27, ll. 21-25, and p. 28, ll. 27-31) and the pump 450/1050 is arranged on an opposing, second side (“lower housing portion”) 320 of the patch 400/900/1010 (see “pump assembly 330” arranged in the bottom side or “lower housing portion 320” in fig. 16, and see p. 27, l. 28, to p. 28, l. 5); and
a controller and transmitter module (“electronic control means”) 360 coupled to the patch 400/900/1010 (see “The electronic control means 360 comprises a PCB or flex-print 362 with a processor 361 for controlling the pump assembly, a battery 366, an acoustic transducer 365 providing an alarm and communication interface with the user, as well as a contact mounted on the actuator al-lowing the control means to be activated by the user when taken into use for the first time (via the actuator 216).” in p. 28, 27-31), wherein the controller and transmitter module 360 comprises an antenna (“a receiver and/or a transmitter”, not labeled) configured to wirelessly communicate with a hand-held user interface device (“remote controller”, not labeled, or “remote control unit 770”) 770 (see “The control means may comprise a receiver and/or a transmitter allowing the reservoir to communicate wirelessly with a remote controller.” in p. 28, ll. 31-32), wherein the controller and transmitter module 360 is configured to operate the pump 450/1050 to deliver insulin based on signals received from the hand-held user interface device (see “The drug delivery device 700 further comprises a remote control unit 770 adapted to wire- lessly communicate with the processor of the pump unit. The remote unit comprises a display 771 and user input keys 772, this allowing the remote unit to display information received from the pump unit (e.g. a visual and/or audible or tactile alarm indicating that the transcutaneous access device has disengaged from its subcutaneous position), and the user to enter flow control commands and instructions on the remote unit which is then transmitted to the pump unit. Indeed, such a remote control unit may also be used in combination with the above-disclosed pump units.” in p. 34, ll. 27-35, and fig. 21).
As to Claim 36, Hansen teaches the following:
wherein the power source 366/661 is arranged on the first side (“upper housing portion”) 310 of the patch 400/900/1010 (see “battery 366” arranged in the top side or “upper housing portion 310” in fig. 16, and see p. 27, ll. 21-25, and p. 28, ll. 27-31) and the pump 450/1050 is arranged on the opposing, second side (“lower housing portion”) 320 of the patch 400/900/1010 in a direction of the short axis of the patch 400/900/1010 (see “pump assembly 330” arranged in the bottom side or “lower housing portion 320” in fig. 16, and see p. 27, l. 28, to p. 28, l. 5), wherein the short axis is perpendicular to the long axis in a plane of the patch 400/900/1010 (see fig. 16).
As to Claim 37, Hansen teaches the following:
wherein the patch 900 is more flexible along the short axis than along the long axis (see “The bottom part 910 further comprises two opposed leg portions 918 each with a lobe 919, the lobes providing attachment points when the bottom part is mounted to a flexible sheet or foil member 901 comprising an adhesive lower mounting surface 904 allowing the transcutaneous unit to be mounted on a skin surface of a subject.” in p. 25, ll. 18-21).
As to Claim 38, Hansen teaches the following:
wherein the antenna (“a receiver and/or a transmitter”, not labeled) extends along the long axis of the patch 400/900 (see “electronic control means 360” extending along the long axis of “pump unit 300” in fig. 16, the “electronic control means 360” comprise “a receiver and/or a transmitter “, see p. 28, ll. 31-32).
As to Claim 39, Hansen teaches the following:
wherein the controller and transmitter module 360 of the insulin delivery device 1000 is in communication with a transcutaneous glucose sensor (see “Although drug infusion pumps, either disposable or durable, may provide convenience of use and improved treatment control, it has long been an object to provide a drug infusion system for the treatment of e.g. diabetes which would rely on closed loop control, i.e. being more or less fully automatic, such a system being based on the measurement of a value indicative of the condition treated, e.g. the blood glucose level in case of insulin treatment of diabetes. A given monitor system for measuring the concentration of a given substance may be based on invasive or non-invasive measuring principles. An example of the latter would be a noninvasive glucose monitor arranged on the skin surface of a patient and using near-IR spectroscopy. The sensor may be placed subcutaneously being connected to external equipment by wiring or the substance (fluid) to be analysed may be transported to an external sensor element, both arrangements requiring the placement of a subcutaneous component, the present invention addressing both arrangements.” in p. 2, l. 28, to p. 3, l. 7).
As to Claim 40, Hansen teaches the following:
wherein the insulin delivery device 1000 is configured to administer insulin based on glucose measurements (see “Although drug infusion pumps, either disposable or durable, may provide convenience of use and improved treatment control, it has long been an object to provide a drug infusion system for the treatment of e.g. diabetes which would rely on closed loop control, i.e. being more or less fully automatic, such a system being based on the measurement of a value indicative of the condition treated, e.g. the blood glucose level in case of insulin treatment of diabetes. A given monitor system for measuring the concentration of a given substance may be based on invasive or non-invasive measuring principles. An example of the latter would be a noninvasive glucose monitor arranged on the skin surface of a patient and using near-IR spectroscopy. The sensor may be placed subcutaneously being connected to external equipment by wiring or the substance (fluid) to be analysed may be transported to an external sensor element, both arrangements requiring the placement of a subcutaneous component, the present invention addressing both arrangements.” in p. 2, l. 28, to p. 3, l. 7).
As to Claim 41, Hansen teaches the following:
wherein the pump 1050 is attached to the patch 1010 via a mounting base (“housing”) 1015 (see “Fig. 12 shows an alternative embodiment of a patch unit 1010 with a pump unit 1050 by its side, and fig. 13 shows the pump unit fully but releasably attached. More specifically, fig. 12 shows an embodiment of a medical device 1000, comprising a cannula unit 1010 of the type shown in fig. 10 and a thereto mountable pump (or reservoir) unit 1050. In the shown embodiment the cannula unit comprises a housing 1015 with a shaft into which a portion 1051 of the pump unit is inserted. The shaft has a lid portion 101 1 with an opening 1012, the free end of the lid forming a flexible latch member 1013 with a lower protrusion (not shown) adapted to engage a corresponding depression 1052 in the pump unit, whereby a snap- action coupling is provided when the pump unit is inserted into the shaft of the cannula unit.” in p. 23, ll. 13-21).
As to Claim 42, Hansen teaches the following:
wherein one or more of the pump 1050, the power source 366, or the controller and transmitter module 360 is integrated into the patch 1010 (see fig. 13).
Claim Rejections - 35 USC § 103
7. 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hansen, as applied to claim 21 above, and further in view of Flaherty et al., U.S. Patent Application Publication No. 2004/0010207 A1 (“Flaherty ‘207”).
As to Claim 25, Hansen teaches the subject matter of claim 21 above. Hansen teaches the following:
wherein the actuator (“reciprocating actuator”) 640 … configured to advance the plunger 622 (see “The device comprises a housing 610, a cylindrical reservoir 620 with a piston 621 and a thereto attached plunger 622, an fluid outlet 630, a reciprocating actuator 640 (e.g. a coil actuator or a SMA actuator), and a drive mechanism 641 arranged between the actuator and the plunger for transforming the actuator input to a forwards movement of the plunger and thus the piston.” in p. 34, ll. 1-5, and fig. 20)
However, Flaherty ‘207 teaches the following:
an actuator (“Actuator portion”) 33 comprising a shape-memory alloy (“shape memory alloy or polymer”, not labeled) … (see “Actuator portion 33 further includes insertion device 43 which includes an insertion plunger 45 coupled to slider 35 at a first end thereof and having a body portion slidably disposed within guide portion 47. An insertion actuator 49 is coupled between a second end of the insertion plunger 45 and the first wall 14. Actuator portion 33 further includes withdrawal device 51 which includes a withdrawal plunger 53 coupled to slider 35 at a first end thereof and having a body portion slidably disposed within guide portion 55. A withdrawal actuator 57 is coupled between a second end of the withdrawal plunger 53 and the second wall 39. In the preferred embodiment, insertion actuator 43 and withdrawal actuator 51 each include a shape memory alloy or polymer which contracts under the influence of an electrical charge.” in para. [0071]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the in9vention was made to modify Hansen’s “reciprocating actuator 640” to Flaherty ‘207’s “Actuator portion 33” because it is a simple substitution of one known element, i.e. Hansen’s “reciprocating actuator 640”, for another, i.e. Flaherty ‘207’s “Actuator portion 33”, to obtain similar predictable results, i.e. to help the transcutaneous administration of insulin.
Conclusion
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 02/23/2026