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 .
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 recites “a hangar for holding an IV bag.” It appears that Applicant intended to claim a hanger for holding IV bangs. A hangar is a large building for storing aircraft.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe et al. (US 2013/0214655) in view of McMillan-Riley (US 2019/0117511).
With respect to Claim 1, Sharpe teaches a container for securing IV medication during use (housing 10 for holding IV fluid, Fig 1-4; "an embodiment 10 of an intravenous fluid hanger housing" para [0018]), comprising:
a housing having a removable cover (housing 10 with removable cover 30, Fig 2), the housing having an internal volume for placement of IV medication (spacing within housing body 30, 40, Fig 2);
a lock for selectively locking the cover to the housing (lock 70, 74 on cover 30, Fig 1-4; "A latch means 70, preferably a keyed latch means, is provided on the door part 30 and engages a slot 72 on the back part 40. In FIG. 2, a cam is shown, shaped and adapted to be received in the slot 72. Cam 74 is rotated by a lock 76 on the outside of door 30." para [0023]); and
a fastener for affixing the housing to an IV pole (cradles 84 and slots 80, 82 in housing 10, Fig 2; "These aligned slots 80, 82 provide a channel through which an IV pole can be positioned when the door part 30 is open (as in FIG. 2), but the closing of the door part (as in FIG. 1) closes off the open end of the slots, effectively securing the IV pole." para [0024]; "One or more cradles 84 for the IV pole allow the IV pole to be directly secured." para [0025]).
Sharpe does not specifically teach that the lock is a biometric lock.
McMillan-Riley teaches a similar locking medication container (medication device 114 with removable front cover 122 and housing enclosure 120, Fig 2-3; para [0025]; lock 140 with locking bar 144 controlled by unlocking means 148, Fig 2-3;) wherein the lock is a biometric lock (148, Fig 2; "While the depicted embodiment includes an electronic keypad 148 it is to be understood that many other forms of input/output devices are possible including, but not limited to biometric readers, fingerprint readers, retinal scanners and face recognition software" para [0031]). Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to have made the lock of Sharpe a biometric lock, as suggested by McMillan-Riley, in order to further ensure the secure holding of medications such as IVs within the housing and to prevent patient tampering.
With respect to Claim 2, Sharpe further teaches wherein the removable cover is hingedly attached to the housing (cover 30 hinged to housing 40, Fig 1-4; "Door part 30 is joined to back part 40 in a hinged manner along the left side face 20" para [0022]).
With respect to Claim 3, Sharpe as modified by McMillan-Riley above reasonably suggests that the biometric lock is a fingerprint lock ("While the depicted embodiment includes an electronic keypad 148 it is to be understood that many other forms of input/output devices are possible including, but not limited to biometric readers, fingerprint readers, retinal scanners and face recognition software"; para [0031] of McMillan-Riley).
With respect to Claim 6, Sharpe further teaches an IV pole and wherein the fastener permanently attaches the housing to the IV pole (cradles 84 and slots 80, 82 in housing 10 taught permanently attaching the housing to the IV pole, since the housing remains permanently attached to the pole while the housing is locked, Fig 2; "These aligned slots 80, 82 provide a channel through which an IV pole can be positioned when the door part 30 is open (as in FIG. 2), but the closing of the door part (as in FIG. 1) closes off the open end of the slots, effectively securing the IV pole." para [0024]; "One or more cradles 84 for the IV pole allow the IV pole to be directly secured." para [0025]).
With respect to Claim 7, Sharpe as modified by McMillan-Riley above reasonably suggests that the biometric lock is configured to store an access log ("The electronic transceiver 118 may be in wireless communication with the healthcare facility server 110 so as to remotely monitor and track the opening and closing of each storage device 114"; para [0032] of McMillan-Riley).
With respect to Claim 8, Sharpe as modified by McMillan-Riley above reasonably suggests a processor (146, Fig 3; "the lock 140 may include a processor 146"; para [0030] of McMillan-Riley).
With respect to Claim 9, Sharpe as modified by McMillan-Riley above reasonably suggests a communication port in electronic communication with the processor (wireless communication through transceiver 118, Fig 1-3; of McMillan-Riley "The electronic transceiver 118 may be in wireless communication with the healthcare facility server 110 so as to remotely monitor and track the opening and closing of each storage device 114" para [0032] of McMillan-Riley).
With respect to Claim 10, Sharpe as modified by McMillan-Riley above reasonably suggests that the processor is configured to communicate with a medication management system by way of the communication port (wireless communication through transceiver 118, Fig 1-3 of McMillan-Riley; "The electronic transceiver 118 may be in wireless communication with the healthcare facility server 110 so as to remotely monitor and track the opening and closing of each storage device 114" para [0032] of McMillan-Riley).
With respect to Claim 11, Sharpe further teaches a hanger for holding an IV bag (86, Fig 2; "FIG. 2 also shows a means 86 for hanging an IV bag inside the housing 10" para [0027]).
With respect to Claim 12, Sharpe further teaches that at least a portion of the cover is transparent (material of housing can be any level of transparent, Fig 1-4; "Many materials will be known as useful for the housing 30. Other aspects of the design decision as to material will be influenced by further considerations, such as the desired amount of transparency/opacity of the material (wide amount of materials useful). In addition to the thermoplastics, drawn and/or pressed metal sheets would also be useful for forming the housing." para [0031]).
With respect to Claim 18, Sharpe teaches a method for securing IV medication during use (housing 10 for holding IV fluid, Fig 1-4; "an embodiment 10 of an intravenous fluid hanger housing" para [0018]), the method comprising:
unlocking a lock of an IV medication container (IV medication container 10 comprising cover 30 and back part 40, Fig 1-4; lock 70, 74 on cover 30, for locking cover 30 in a closed position against housing 40, Fig 1-4; "A latch means 70, preferably a keyed latch means, is provided on the door part 30 and engages a slot 72 on the back part 40. In FIG. 2, a cam 74 is shown, shaped and adapted to be received in the slot 72. Cam 74 is rotated by a lock 76 on the outside of door 30." para [0023]), wherein the IV medication container is secured to an IV pole (cradles 84 and slots 80, 82 in housing 40, Fig 2; "These aligned slots 80, 82 provide a channel through which an IV pole can be positioned when the door part 30 is open (as in FIG. 2), but the closing of the door part (as in FIG. 1) closes off the open end of the slots, effectively securing the IV pole." para [0024]; "One or more cradles 84 for the IV pole allow the IV pole to be directly secured." para [0025]).
Sharpe does not specifically teach that the lock is a biometric lock, such that the container will unlock the biometric lock of an IV medication container when an authorized user is authenticated, record access by the authorized user in an access log, and lock the biometric lock upon closure of the IV medication container.
McMillan-Riley teaches a similar locking medication container (medication device 114 with removable front cover 122 and housing enclosure 120, Fig 2-3; para [0025]; lock 140 with locking bar 144 controlled by unlocking means 148, Fig 2-3;) wherein the lock is a biometric lock (148, Fig 2; "While the depicted embodiment includes an electronic keypad 148 it is to be understood that many other forms of input/output devices are possible including, but not limited to biometric readers, fingerprint readers, retinal scanners and face recognition software" para [0031]) and wherein the container records access by the user ("The electronic transceiver 118 may be in wireless communication with the healthcare facility server 110 so as to remotely monitor and track the opening and closing of each storage device 114" para [0032]). The biometric lock will reengage to lock the container upon closure (para [0011]). Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to have made the lock of Sharpe a biometric lock that unlocks upon authentication of an authorized user, records access by the user, and relocks upon closure, as suggested by McMillan-Riley, in order to further ensure the secure holding and tracking of medications such as IVs within the housing and to prevent patient tampering.
With respect to Claim 20, Sharpe as modified by McMillan-Riley above reasonably suggests that the access log is maintained by a medication management system in communication with the biometric lock ("The electronic transceiver 118 may be in wireless communication with the healthcare facility server 110 so as to remotely monitor and track the opening and closing of each storage device 114" para [0032] of McMillan-Riley).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe and McMillan-Riley as applied to claim 1 above, and further in view of DeVore (US 2013/0081966).
With respect to Claim 4, Sharpe and McMillan-Riley reasonably suggest the container of Claim 1, and Sharpe further teaches the fastener (cradles 84 and slots 80, 82 in housing 40, Fig 2) is configured to be removable (cradles 84 removable from the pole upon opening of the door, Fig. 2). Sharpe, however, does not teach that the fastener is configured to be removable and is only operable from within the housing.
Devore teaches a similar IV pole attached to a box via a removable clamp (box 11 clamped to pole 13 via clamp 12, Fig 2; para [0030]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to have replaced the cradles of Sharpe with clamps, as suggested by DeVore, in order to better secure the box to the pole without the pole disconnecting from the box when the box is opened, thereby allowing for the fasteners to be removable and only operable from within the housing.
With respect to Claim 5, Sharpe, McMillan-Riley, and DeVore reasonably suggest the container of Claim 4, and DeVore further teaches wherein the fastener is one or more of a clamp, a screw, a bolt, a latch, a buckle, and a strap ("clamp 12" para [0030]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sharpe and McMillan-Riley as applied to claims 1 and 12 above, and further in view of Wigmore (US 6,595,365).
With respect to Claim 13, Sharpe and McMillan-Riley reasonably suggest the container of claim 12 as claimed, wherein at least a portion of the cover of the container is transparent (para [0031] of Sharpe). Sharpe, however, does not explicitly teach that the cover is tinted.
Wigmore teaches a container with a locking device for storing pills or other medication (Abstract; Column 2, Line 65 through Column 3, Line 2), wherein the container may be made of amber-tinted, translucent plastic so as to shield the contained medications from ultraviolet rays that can reduce the strength of medications (Column 3, Lines 10-14; Column 5, Lines 55-62). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Sharpe’s translucent container to be made from translucent, amber-tinted plastic, as suggested by Wigmore, in order to shield the contained medications from ultraviolet rays that can reduce the strength of medications (Column 3, Lines 10-14; Column 5, Lines 55-62).
Claim 14, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe and McMillan-Riley as applied to claims 1 and 18 above, and further in view of Schoenfeld (US 2007/0244598).
With respect to Claim 14, Sharpe further teaches the container (housing 10 for holding IV fluid, Fig 1-4) but is silent as to further comprising an alarm. However, Shoenfeld teaches a similar medical container comprising an alarm (medicine cabinet 30 with drawers 36, Fig 1; "If the drawer has been left open for more than some programmed threshold time, a local alarm, i.e., buzzer, can be sounded, and the open status is also transmitted to the main hospital computer." para [0015]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Sharpe’s container to include an alarm on the container, as suggested by Shoenfeld, in order to further alert the user in case the box is not closed properly or in.a timely manner.
With respect to Claim 15, the modified Sharpe teaches container of claim 14, and as modified by Shoenfeld, further teaches wherein the alarm is configured to be triggered when the cover has been removed from the housing for a time greater than a predetermined period of time ("If the drawer has been left open for more than some programmed threshold time, a local alarm, i.e., buzzer, can be sounded, and the open status is also transmitted to the main hospital computer." para [0015] of Schoenfeld).
With respect to Claim 19, the Sharpe and MicMillan-Riley reasonably suggest the method of claim 18, and Sharpe further teaches the container (housing 10 for holding IV fluid, Fig 1-4) and as modified by McMillan-Riley further teaches the biometric lock (148, Fig 2; "While the depicted embodiment includes an electronic keypad 148 it is to be understood that many other forms of input/output devices are possible including, but not limited to biometric readers, fingerprint readers, retinal scanners and face recognition software" para [0031]), but is silent as to further comprising triggering an alarm when a period of time between unlocking the biometric lock and closure of the IV medication container exceeds a predetermined alarm time.
However, Shoenfeld teaches a similar medical container comprising an alarm (medicine cabinet 30 with drawers 36, Fig 1; "If the drawer has been left open for more than some programmed threshold time, a local alarm, i.e., buzzer, can be sounded, and the open status is also transmitted to the main hospital computer." para [0015]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Sharpe’s container to include an alarm to the container, as suggested by Shoenfeld to further alert the user in case the box is not closed properly or in a timely manner.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sharpe and McMillan-Riley as applied to claim 1 above, and further in view of Foot et al. (US 2017/0228951).
With respect to Claim 16, the modified Sharpe teaches the container of claim 1, and as modified by McMillan-Riley, further teaches the biometric lock (148, Fig 2; "While the depicted embodiment includes an electronic keypad 148 it is to be understood that many other forms of input/output devices are possible including, but not limited to biometric readers, fingerprint readers, retinal scanners and face recognition
software" para [0031]). Sharpe and McMillan-Riley, however, do not explicitly teach comprising a battery for powering the biometric lock.
Foot teaches a similar locked box comprising a rechargeable battery for powering an electronic lock (box 700, Fig 7-8; battery 804, Fig 8; "Stand-alone relay box 700 includes a battery 804 for supplying power to microcontroller 802 and other elements" para [0042]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Sharpe’s container to include a battery as the source of power to continue proper functioning of the biometric lock, as suggested by Foot, in order to ensure proper functioning over continual opening, closing, and monitoring of the lock over time without the need to be plugged in.
With respect to Claim 17, the modified Sharpe reasonably suggest the container of Claim 16, and Foot further teaches that the battery is rechargeable (battery 804, Fig 7-8; "For example, battery 804 may be a rechargeable battery" para [0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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